Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2018 | Oct. 29, 2018 | |
Document And Entity Information [Abstract] | ||
Entity Registrant Name | AGIOS PHARMACEUTICALS INC | |
Trading Symbol | AGIO | |
Entity Central Index Key | 1,439,222 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2018 | |
Document Fiscal Year Focus | 2,018 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false | |
Entity Common Stock, Shares Outstanding | 58,178,676 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 156,478 | $ 102,724 |
Marketable securities | 513,414 | 321,212 |
Accounts receivable, net | 2,631 | 0 |
Collaboration receivable – related party | 3,395 | 2,448 |
Collaboration receivable – other | 440 | 0 |
Royalty receivable – related party | 1,863 | 1,222 |
Inventory | 863 | 0 |
Prepaid expenses and other current assets | 16,458 | 17,655 |
Total current assets | 695,542 | 445,261 |
Marketable securities | 208,508 | 143,814 |
Property and equipment, net | 24,613 | 24,431 |
Other non-current assets | 416 | 891 |
Total assets | 929,079 | 614,397 |
Current liabilities: | ||
Accounts payable | 16,616 | 22,767 |
Accrued expenses | 25,303 | 34,031 |
Deferred revenue – related party | 42,141 | 37,842 |
Deferred rent | 686 | 301 |
Total current liabilities | 84,746 | 94,941 |
Deferred revenue, net of current portion – related party | 66,294 | 125,798 |
Deferred rent, net of current portion | 17,826 | 18,155 |
Total liabilities | 168,866 | 238,894 |
Stockholders’ equity: | ||
Preferred stock, $0.001 par value; 25,000,000 shares authorized; no shares issued or outstanding at September 30, 2018 and December 31, 2017 | 0 | 0 |
Common stock, $0.001 par value; 125,000,000 shares authorized; 58,167,932 and 48,826,153 shares issued and outstanding at September 30, 2018 and December 31, 2017, respectively | 58 | 49 |
Additional paid-in capital | 1,775,113 | 1,174,904 |
Accumulated other comprehensive loss | (2,119) | (1,389) |
Accumulated deficit | (1,012,839) | (798,061) |
Total stockholders’ equity | 760,213 | 375,503 |
Total liabilities and stockholders’ equity | $ 929,079 | $ 614,397 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2018 | Dec. 31, 2017 |
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) | 58,167,932 | 48,826,153 |
Common stock, shares outstanding (in shares) | 58,167,932 | 48,826,153 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Revenues: | ||||
Revenues | $ 15,198 | $ 11,358 | $ 64,374 | $ 33,212 |
Costs and expenses: | ||||
Cost of sales | 695 | 0 | 695 | 0 |
Research and development (net of $1,078 and $6,343 of cost reimbursement from related party for the three and nine months ended September 30, 2017) | 82,561 | 72,917 | 247,515 | 215,465 |
Sales, general and administrative | 31,104 | 17,458 | 82,287 | 48,411 |
Total costs and expenses | 114,360 | 90,375 | 330,497 | 263,876 |
Loss from operations | (99,162) | (79,017) | (266,123) | (230,664) |
Interest income | 4,498 | 1,880 | 11,889 | 4,279 |
Net loss | $ (94,664) | $ (77,137) | $ (254,234) | $ (226,385) |
Net loss per share – basic and diluted (usd per share) | $ (1.63) | $ (1.59) | $ (4.45) | $ (4.94) |
Weighted-average number of common shares used in computing net loss per share – basic and diluted (in shares) | 58,033,386 | 48,459,424 | 57,158,492 | 45,851,203 |
Product revenue, net | ||||
Revenues: | ||||
Revenues | $ 4,465 | $ 0 | $ 4,465 | $ 0 |
Collaboration revenue - related party | ||||
Revenues: | ||||
Revenues | 8,732 | 10,643 | 42,478 | 32,497 |
Collaboration revenue - other | ||||
Revenues: | ||||
Revenues | 0 | 0 | 12,440 | 0 |
Royalty revenue - related party | ||||
Revenues: | ||||
Revenues | $ 2,001 | $ 715 | $ 4,991 | $ 715 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Operations (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Income Statement [Abstract] | ||||
Related party research and development expense | $ 0 | $ 1,078 | $ 0 | $ 6,343 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (94,664) | $ (77,137) | $ (254,234) | $ (226,385) |
Other comprehensive income (loss) | ||||
Unrealized gain (loss) on available-for-sale securities | 279 | 135 | (730) | (202) |
Comprehensive loss | $ (94,385) | $ (77,002) | $ (254,964) | $ (226,587) |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
Operating activities | ||
Net loss | $ (254,234) | $ (226,385) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 5,261 | 4,778 |
Stock-based compensation expense | 55,170 | 35,128 |
Net amortization of premium and discounts on investments | (2,540) | 25 |
(Gain) loss on disposal of property and equipment | (20) | 40 |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | (2,631) | 0 |
Collaboration receivable – related party | (947) | 1,397 |
Collaboration receivable – other | (440) | 0 |
Royalty receivable – related party | (641) | (715) |
Inventory | (863) | 0 |
Prepaid expenses and other current and non-current assets | 1,711 | (1,886) |
Accounts payable | (5,830) | 742 |
Accrued expenses | (8,537) | (1,242) |
Deferred revenue – related party | (15,749) | (20,141) |
Deferred rent | 56 | (2,519) |
Net cash used in operating activities | (230,234) | (210,778) |
Investing activities | ||
Purchases of marketable securities | (755,368) | (604,525) |
Proceeds from maturities and sales of marketable securities | 500,281 | 508,116 |
Purchases of property and equipment | (5,933) | (3,347) |
Net cash used in investing activities | (261,020) | (99,756) |
Financing activities | ||
Payment of public offering costs, net of reimbursements | (391) | (89) |
Proceeds from public offering of common stock, net of commissions | 516,206 | 270,250 |
Net proceeds from stock option exercises and employee stock purchase plan | 29,193 | 12,360 |
Net cash provided by financing activities | 545,008 | 282,521 |
Net change in cash and cash equivalents | 53,754 | (28,013) |
Cash and cash equivalents at beginning of the period | 102,724 | 160,754 |
Cash and cash equivalents at end of the period | 156,478 | 132,741 |
Supplemental disclosure of non-cash investing and financing transactions | ||
Additions to property and equipment in accounts payable and accrued expenses | 501 | 226 |
Proceeds from stock option exercises in other current assets | 39 | 95 |
Public offering costs in other current assets, net of amounts in accounts payable and accrued expenses | $ 0 | $ 318 |
Overview and Basis of Presentat
Overview and Basis of Presentation | 9 Months Ended |
Sep. 30, 2018 | |
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, with the goal of making transformative, first- or best-in-class medicines. Our therapeutic areas of focus are cancer and rare genetic diseases, or RGDs, which are diseases that are directly caused by changes in genes or chromosomes, often passed from one generation to the next. Most RGDs are often associated with severe or life-threatening features. The incidence of a single RGD can vary widely but is generally very infrequent, usually equal to or less than one per 100,000 births. In both areas of cancer and RGDs, we are seeking to unlock the biology of cellular metabolism as a platform to create transformative therapies. We are located in Cambridge, Massachusetts. Basis of presentation The condensed consolidated balance sheet as of September 30, 2018, the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2018 and 2017, and cash flows for the nine months ended September 30, 2018 and 2017 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 September 30, 2018, our results of operations for the three and nine months ended September 30, 2018 and 2017, and cash flows for the nine months ended September 30, 2018 and 2017. The financial data and the other financial information disclosed in these notes to the condensed consolidated financial statements related to the three and nine-month period are also unaudited. The results of operations for the three and nine months ended September 30, 2018 are not necessarily indicative of the results to be expected for the year ending December 31, 2018 or for any other future annual or interim period. The year-end condensed consolidated balance sheet data 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. Accordingly, 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, 2017 that was filed with the Securities and Exchange Commission, or the SEC, on February 14, 2018. Our condensed consolidated financial statements include our accounts and the accounts of our wholly owned subsidiaries, Agios Securities Corporation, Agios International Sarl, and Agios Limited. All intercompany transactions have been eliminated in consolidation. The condensed consolidated financial statements have been prepared in conformity with U.S. GAAP. Liquidity In January 2018, we completed a public offering of 8,152,986 shares of common stock at an offering price of $67.00 per share. We received net proceeds from this offering of $516.2 million, after deducting underwriting discounts and commissions paid by us. As of September 30, 2018, we had cash, cash equivalents and marketable securities of $878.4 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 marketable securities will be sufficient to fund current operations for at least the next twelve months from the issuance date of these financial statements. |
Summary of Significant Accounti
Summary of Significant Accounting Policies and Recent Accounting Pronouncements | 9 Months Ended |
Sep. 30, 2018 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies and Recent Accounting Pronouncements | Summary of Significant Accounting Policies and Recent Accounting Pronouncements Significant accounting policies Accounts receivable, net Our trade accounts receivable arise from product sales and represent amounts due from specialty distributors and specialty pharmacy providers in the U.S. We monitor the financial performance and creditworthiness of our customers so that we can properly assess and respond to changes in their credit profile. We reserve against these receivables for estimated losses that may arise from a customer’s inability to pay. Amounts determined to be uncollectible are charged or written-off against the reserve. Concentrations of credit risk Financial instruments which potentially subject us to credit risk consist primarily of cash, cash equivalents, and marketable securities. We hold these investments in highly rated financial institutions, and, by policy, limit the amounts of credit exposure to any one financial institution. These amounts at times may exceed federally insured limits. We have not experienced any credit losses in such accounts and do not believe we are exposed to any significant credit risk on these funds. We have no off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts, option contracts, or other hedging arrangements. We are also subject to credit risk on our receivables, including trade receivables from our customers and collaboration and royalty receivables from Celgene Corporation, or Celgene, and CStone Pharmaceuticals, or CStone. Concentrations of credit risk with respect to receivables, which are typically unsecured, are somewhat mitigated due to the number of customers using our products. Our trade receivables arise from product sales in the U.S. and have standard payment terms that generally require payment within 30 to 60 days. We have evaluated the creditworthiness of our customers, including Celgene, and determined them to be creditworthy. To date we have not experienced any losses with respect to our receivables. Inventory Inventory is stated at the lower of cost or estimated net realizable value on a first-in, first-out basis. Prior to the regulatory approval of our product candidates, we incur expenses for the manufacture of drug product that could potentially be available to support the commercial launch of those products. Until the date at which regulatory approval has been received or is otherwise considered probable, we record all such costs as research and development expenses. Our wholly owned product, TIBSOVO® (ivosidenib), received approval from the U.S. Food and Drug Administration, or FDA, on July 20, 2018 for the treatment of adult patients with relapsed or refractory acute myeloid leukemia, or R/R AML, with susceptible isocitrate dehydrogenase 1, or IDH1, mutation as detected by an FDA-approved test, and we began to capitalize inventories of TIBSOVO® beginning on July 20, 2018. We perform an assessment of the recoverability of capitalized inventory during each reporting period and write down any excess and obsolete inventory to its estimated net realizable value in the period in which the impairment is first identified. Such impairment charges, should they occur, are recorded as a component of cost of sales in the condensed consolidated statements of operations. The determination of whether inventory costs will be realizable requires the use of estimates by management. If actual market conditions are less favorable than projected by management, additional write-downs of inventory may be required. Revenue from Contracts with Customers In May 2014, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, No. 2014-09, Revenue from Contracts with Customers (Topic 606) , which was codified as Accounting Standards Codification 606, Revenue from Contracts with Customers, or ASC 606, and amended through subsequent ASUs. We adopted ASC 606 effective January 1, 2018 using the modified retrospective method. Under this method, we recognized the cumulative effect of the change in the opening balance of accumulated deficit in the current period condensed consolidated balance sheet. In adopting ASC 606, we applied the practical expedient that permits aggregating the effect of all contract modifications that occurred prior to January 1, 2018. No other practical expedients were used. Upon finalization of our assessment, which resulted in changes to our estimates as of December 31, 2017, the impact of the cumulative effect of the accounting changes upon the adoption of the standard (in thousands) is as follows: December 31, 2017 Cumulative Effect January 1, 2018 Deferred revenue – related party, current and net of current portions $ 163,640 $ (39,456) $ 124,184 Accumulated deficit (798,061) 39,456 (758,605) The following tables summarize the effects of adopting ASC 606 on our unaudited condensed consolidated financial statements (in thousands, except per share data): Condensed Consolidated Balance Sheets September 30, 2018 Under Topic Under Topic Effect of Accounts receivable, net $ 2,631 $ 2,631 $ — Collaboration receivable – related party 3,395 3,395 — Collaboration receivable – other 440 — 440 Total current assets 695,542 695,102 440 Total assets 929,079 928,639 440 Deferred revenue – related party 42,141 33,648 8,493 Total current liabilities 84,746 76,253 8,493 Deferred revenue, net of current portion – related party 66,294 107,714 (41,420) Total liabilities 168,866 201,793 (32,927) Accumulated deficit (1,012,839) (1,046,206) 33,367 Total stockholders’ equity 760,213 726,846 33,367 Total liabilities and stockholders’ equity 929,079 928,639 440 Condensed Consolidated Statements of Operations Three Months Ended September 30, 2018 Nine Months Ended September 30, 2018 Under Topic Under Topic Effect of Under Topic Under Topic Effect of Product revenue, net $ 4,465 $ 4,465 $ — $ 4,465 $ 4,465 $ — Collaboration revenue – related party 8,732 10,137 (1,405) 42,478 46,096 (3,618) Collaboration revenue – other — — — 12,440 12,000 440 Research and development expense 82,561 81,714 847 247,515 244,604 2,911 Total cost and expenses 114,360 113,513 847 330,497 327,586 2,911 Loss from operations (99,162) (96,910) (2,252) (266,123) (260,034) (6,089) Net loss (94,664) (92,412) (2,252) (254,234) (248,145) (6,089) Net loss per share – basic and diluted (1.63) (1.59) (0.04) (4.45) (4.34) (0.11) Condensed Consolidated Statements of Comprehensive Loss Three Months Ended September 30, 2018 Nine Months Ended September 30, 2018 Under Topic Under Topic Effect of Under Topic Under Topic Effect of Net loss $ (94,664) $ (92,412) $ (2,252) $ (254,234) $ (248,145) $ (6,089) Comprehensive loss (94,385) (92,133) (2,252) (254,964) (248,875) (6,089) Condensed Consolidated Statements of Cash Flows Nine Months Ended September 30, 2018 Under Topic Under Topic Effect of Net loss $ (254,234) $ (248,145) $ (6,089) Adjustments to reconcile net loss to net cash used in operating activities: Accounts receivable, net (2,631) (2,631) — Collaboration receivable – related party (947) (947) — Collaboration receivable – other (440) — (440) Deferred revenue – related party (15,749) (22,278) 6,529 Cost of Sales Cost of sales consists primarily of manufacturing costs of TIBSOVO ® . Based on our policy to expense costs associated with the manufacturing of our products prior to regulatory approval, certain of the manufacturing costs associated with product shipments of TIBSOVO® recorded during the three and nine months ended September 30, 2018 were expensed prior to July 20, 2018 and, therefore, are not included in costs of sales during the current period. Recent accounting pronouncements In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842), which was codified as ASC 842, Leases , and amended through subsequent ASUs. We are in the process of reviewing our existing lease contracts and continue to evaluate the accounting implications of ASC 842. We will adopt the guidance effective January 1, 2019 using the modified retrospective transition approach and we expect to elect the package of practical expedients, both provided for under ASU No. 2018-11, Leases (Topic 842): Targeted Improvements . The package of practical expedients allows us not to reassess whether contracts are or contain leases, lease classification, and whether initial direct costs qualify for capitalization. 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 | 9 Months Ended |
Sep. 30, 2018 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements We record cash equivalents and marketable securities at fair value. ASC 820, Fair Value Measurements and Disclosures , establishes a fair value hierarchy for those instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and our own assumptions (unobservable inputs). The hierarchy consists of three levels: Level 1 – Unadjusted quoted prices in active markets for identical assets or liabilities. Level 2 – Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs which are observable, directly or indirectly, for substantially the full term of the asset or liability. Level 3 – Unobservable inputs that reflect our own assumptions about the assumptions market participants would use in pricing the asset or liability in which there is little, if any, market activity for the asset or liability at the measurement date. The following table summarizes our cash equivalents and marketable securities measured at fair value on a recurring basis as of September 30, 2018 (in thousands): Level 1 Level 2 Level 3 Total Cash equivalents $ 129,123 $ 24,001 $ — $ 153,124 Marketable securities: Certificates of deposit — 954 — 954 U.S. Treasuries — 266,119 — 266,119 Government securities — 114,407 — 114,407 Corporate debt securities — 340,442 — 340,442 Total cash equivalents and marketable securities $ 129,123 $ 745,923 $ — $ 875,046 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 September 30, 2018. There have been no changes to the valuation methods during the nine months ended September 30, 2018. We evaluate transfers between levels at the end of each reporting period. There were no transfers between Level 1 and Level 2 during the nine months ended September 30, 2018. We have no financial assets or liabilities that were classified as Level 3 at any point during the nine months ended September 30, 2018. |
Marketable Securities
Marketable Securities | 9 Months Ended |
Sep. 30, 2018 | |
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, with unrealized gains and losses included as a component of accumulated other comprehensive loss in stockholders’ equity and a component of total comprehensive loss in the condensed consolidated statements of comprehensive loss, until realized. Realized gains and losses are included in investment income on a specific-identification basis. There were no realized gains or losses on marketable securities for the three and nine months ended September 30, 2018 and 2017 and, as a result, there were no reclassifications of any amounts out of accumulated other comprehensive loss for those periods. Marketable securities at September 30, 2018 consisted of the following (in thousands): Amortized Unrealized Unrealized Fair Current: Certificates of deposit $ 960 $ — $ (6) $ 954 U.S Treasuries 244,818 — (302) 244,516 Government securities 61,522 — (163) 61,359 Corporate debt securities 206,948 — (363) 206,585 Non-current: Certificates of deposit — — — — U.S Treasuries 21,860 — (257) 21,603 Government securities 53,301 — (253) 53,048 Corporate debt securities 134,632 — (775) 133,857 Total marketable securities $ 724,041 $ — $ (2,119) $ 721,922 Marketable securities at December 31, 2017 consisted of the following (in thousands): Amortized Unrealized Unrealized Fair Current: Certificates of deposit $ 8,081 $ — $ (11) $ 8,070 U.S. Treasuries 113,852 — (119) 113,733 Government securities 44,421 — (57) 44,364 Corporate debt securities 155,222 — (177) 155,045 Non-current: Certificates of deposit 960 — (8) 952 U.S. Treasuries 36,165 — (311) 35,854 Government securities 23,992 — (182) 23,810 Corporate debt securities 83,722 — (524) 83,198 Total marketable securities $ 466,415 $ — $ (1,389) $ 465,026 At September 30, 2018 and December 31, 2017, 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 one year to two years, and (ii) we do not intend to liquidate within the next twelve months, although these funds are available for use and therefore classified as available-for-sale. At September 30, 2018 and December 31, 2017, we held 236 and 240 debt securities that were in an unrealized loss position for less than one year, respectively. The aggregate fair value of debt securities in an unrealized loss position at September 30, 2018 and December 31, 2017 was $659.8 million and $439.4 million, respectively. There were no individual securities that were in a significant unrealized loss position as of September 30, 2018 and December 31, 2017. Given our intent and ability to hold such securities until recovery, and the lack of material of change in the credit risk of these investments, we do not consider these marketable securities to be other-than-temporarily impaired as of September 30, 2018 and December 31, 2017. |
Inventory
Inventory | 9 Months Ended |
Sep. 30, 2018 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventory Inventory consists of the following (in thousands): September 30, Raw materials $ — Work-in-process 788 Finished goods 75 Total Inventory $ 863 |
Accrued Expenses
Accrued Expenses | 9 Months Ended |
Sep. 30, 2018 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | Accrued Expenses Accrued expenses consist of the following (in thousands): September 30, December 31, Accrued compensation $ 11,748 $ 15,693 Accrued research and development costs 10,535 14,849 Accrued professional fees 2,509 3,140 Accrued other 511 349 Total accrued expenses $ 25,303 $ 34,031 |
Product Revenue
Product Revenue | 9 Months Ended |
Sep. 30, 2018 | |
Revenue from Contract with Customer [Abstract] | |
Product Revenue | Product Revenue Our wholly owned product, TIBSOVO®, received approval from the FDA on July 20, 2018 for the treatment of adult patients with R/R AML with a susceptible IDH1 mutation. Upon FDA approval of TIBSOVO® in the U.S. we began generating product revenue from sales of TIBSOVO®. We sell TIBSOVO® 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. 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. To date, our source of product revenue has been U.S. sales of TIBSOVO®. Total net product revenue was $4.5 million for the three and nine months ended September 30, 2018, respectively. The following table summarizes balances and activity in each of the product revenue allowance and reserve categories for the nine months ended September 30, 2018 (in thousands): Contractual Adjustments Government Rebates Returns Total Balance at December 31, 2017 $ — $ — $ — $ — Current provisions relating to sales in the current year 360 135 106 601 Payments/returns relating to sales in the current year (180) — — (180) Balance at September 30, 2018 $ 180 $ 135 $ 106 $ 421 Total revenue-related reserves above, included in our condensed consolidated balance sheets, are summarized as follows (in thousands): September 30, 2018 Reduction of accounts receivable $ 98 Component of accrued expenses 323 Total revenue-related reserves $ 421 The following table presents changes in our contract assets and liabilities during the nine months ended September 30, 2018 (in thousands): December 31, 2017 Additions Deductions September 30, 2018 Contract assets (1) Accounts receivable, net $ — $ 5,328 $ (2,697) $ 2,631 |
Collaboration and License Agree
Collaboration and License Agreements | 9 Months Ended |
Sep. 30, 2018 | |
Revenue Recognition and Deferred Revenue [Abstract] | |
Collaboration and License Agreements | Collaboration and License Agreements Celgene Corporation To date, our revenue has primarily been generated from our collaboration agreements with Celgene, or collectively, the Collaboration Agreements. Celgene 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. The 2010 Agreement was amended in October 2011 and July 2014. 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 AG-881 products. The AG-881 Agreements were terminated effective September 4, 2018. In May 2016, we entered into a master research and collaboration agreement with Celgene, or the 2016 Agreement. 2016 Agreement In May 2016, we entered into the 2016 Agreement focused on metabolic immuno-oncology, or MIO, a developing field which aims to modulate the activity of relevant immune cells by targeting critical metabolic nodes, thereby enhancing the immune mediated anti-tumor response. In addition to new programs identified under the 2016 Agreement, both parties also agreed that all future development and commercialization of two remaining cancer metabolism programs discovered under the 2010 Agreement, including AG-270, an inhibitor of methionine adenosyltransferase 2a, will now be governed by the 2016 Agreement. During the research term of the 2016 Agreement, we plan to conduct research programs focused on discovering compounds that are active against metabolic targets in the immuno-oncology, or IO, field. The initial four one For each program under the 2016 Agreement, we may nominate compounds that meet specified criteria as development candidates and, in limited circumstances, Celgene may also nominate compounds as development candidates for each such program. Celgene may designate the applicable program for further development following any such nomination, after which we may conduct, at our expense, additional preclinical and clinical development for such program through the completion of an initial phase 1 dose escalation study. At the end of the research term, Celgene may designate for continued development up to three research programs for which development candidates have yet to be nominated, which are referred to as continuation programs. We may conduct further research and preclinical and clinical development activities on any continuation program, at our expense, through the completion of an initial phase 1 dose escalation study. We granted Celgene the right to obtain exclusive options for development and commercialization rights for each program that Celgene has designated for further development, and for each continuation program. Celgene may exercise each such option beginning on the designation of a development candidate for such program (or on the designation of such program as a continuation program) and ending on the earlier of: (i) the end of a specified period after we have furnished Celgene with specified information about the initial phase 1 dose escalation study for such program, or (ii) January 1, 2030. Research programs that have applications in the inflammation or autoimmune, or I&I, field that may result from the 2016 Agreement will also be subject to the exclusive options described above. We will retain rights to any program that Celgene does not designate for further development or as to which it does not exercise its option. Under the terms of the 2016 Agreement, following Celgene’s exercise of its option with respect to a program, the parties will enter into either a co-development and co-commercialization agreement if such program is in the IO field, or a license agreement if such program is in the I&I field. Under each co-development and co-commercialization agreement, the two parties will co-develop and co-commercialize licensed products worldwide. Either we or Celgene will lead development and commercialization of licensed products for the United States, and Celgene will lead development and commercialization of licensed products outside of the United States. Depending on the country, the parties will each have the right to provide a portion of field-based marketing activities. Under each license agreement, Celgene will have the sole right to develop and commercialize licensed products worldwide. Co-development and co-commercialization agreements Under each co-development and co-commercialization agreement entered into under the 2016 Agreement, the parties will split all post-option exercise worldwide development costs, subject to specified exceptions, as well as any profits from any net sales of, or commercialization losses related to, licensed products in the IO field. Celgene has the option to designate one program in the IO field as the 65/35 program, for which Celgene will be the lead party for the United States and will have a 65% profit or loss share. For programs in the IO field other than the 65/35 program, we and Celgene will alternate, on a program-by-program basis, being the lead party for the United States, with us having the right to be the lead party for the first such program, and each party will have a 50% profit or loss share. The lead party for the United States will book commercial sales of licensed products, if any, in the United States, and Celgene will book commercial sales of licensed products, if any, outside of the United States. License agreements Under each license agreement under the 2016 Agreement, Celgene will be responsible for all post-option exercise worldwide development and associated costs, subject to specified exceptions, as well as worldwide commercialization and associated costs, for licensed products in the I&I field. Financial terms Under the terms of the 2016 Agreement, we received an initial upfront payment in the amount of $200.0 million. The 2016 Agreement provides specified rights to extend the research term for up to two, or in specified cases, up to four, additional years by paying a $40.0 million per-year extension fee. Celgene will pay an $8.0 million designation fee for each program that Celgene designates for further development and for each continuation program. During the three months ended March 31, 2017, we received $8.0 million from Celgene upon the designation of AG-270 as a development candidate. For each program as to which Celgene exercises its option to develop and commercialize, subject to antitrust clearance, Celgene will pay an option exercise fee of at least $30.0 million for any designated development program and at least $35.0 million for any continuation programs. In certain cases, Celgene may exercise its option to develop and commercialize two early-stage I&I programs, prior to Celgene designating the program for further development, by paying an option exercise fee of $10.0 million. We are eligible to receive the following milestone-based payments associated with the 2016 Agreement: Program Milestone Amount 65/35 program in IO field Specified clinical development event $25.0 million 65/35 program in IO field Specified regulatory milestone events Up to $183.8 million 50/50 program in IO field Specified clinical development event $20.0 million 50/50 program in IO field Specified regulatory milestone events Up to $148.8 million I&I field Specified clinical development event $25.0 million I&I field Specified regulatory milestone events Up to $236.3 million I&I field Specified commercial milestone events Up to $125.0 million Additionally, for each licensed program in the I&I field, we are eligible to receive royalties at tiered, low double-digit percentage rates on Celgene’s net sales, if any. Opt-out right Under the 2016 Agreement, we may elect to opt out of the cost and profit share under any co-development and co-commercialization agreement, subject to specified exceptions. Upon opting out, Celgene will have the sole right to develop, manufacture and commercialize the applicable licensed products throughout the world, at its cost, and we will undertake transitional activities reasonably necessary to transfer the development, manufacture and commercialization of such licensed products to Celgene, at our expense. Further, in lieu of the profit or loss sharing described above, we would be eligible to receive royalties at tiered, low double-digit percentage rates on Celgene’s net sales, if any, of the applicable licensed products. However, we would continue to be eligible to receive the developmental and regulatory milestone-based payments described above. Term The term of the 2016 Agreement commenced on May 17, 2016 and, if not terminated earlier, will expire upon the later of the last-to-expire of the research term and all option exercise periods, or, if an option is exercised by Celgene for one or more programs in the collaboration, upon the termination or expiration of the last-to-exist co-development and co-commercialization agreement or license agreement, as applicable, for any such program. Termination Subject to specified exceptions, Celgene may terminate the 2016 Agreement in its entirety for any reason by providing us with prior written notice if there are no active co-development and co-commercialization agreements or license agreements in place or on a program-by-program basis if there are no active co-development and co-commercialization agreements or license agreements in place for the terminated program(s). Either party may terminate the 2016 Agreement for the insolvency of the other party. On a program-by-program basis, prior to the exercise of an option, either party may terminate the 2016 Agreement either in its entirety or with respect to one or more programs on prior written notice to the other party in the case of an uncured material breach by the other party that frustrates the fundamental purpose of the 2016 Agreement. Following the exercise of an option for a program, either party may terminate the 2016 Agreement with respect to such program if such party terminates the co-development and co-commercialization agreement or license agreement for such program for an uncured material breach by the other party that frustrates the fundamental purpose of such agreement. Either party may terminate a co-development and co-commercialization agreement or a license agreement upon the bankruptcy or insolvency of the other party. Either party also has the right to terminate the co-development and co-commercialization agreement or license agreement if the other party or any of its affiliates challenges the validity, scope or enforceability of or otherwise opposes, any patent included within the intellectual property rights licensed to the other party under such agreement. Exclusivity While any of Celgene’s options remain available under the 2016 Agreement, subject to specified exceptions, we may not directly or indirectly develop, manufacture or commercialize, outside of the 2016 Agreement, any therapeutic modality in the IO or I&I field with specified activity against a metabolic target. During the term of each co-development and co-commercialization agreement and license agreement, subject to specified exceptions, neither we nor Celgene may directly or indirectly develop, manufacture or commercialize outside of such agreement any therapeutic modality in any field with specified activity against the metabolic target that is the focus of the program licensed under such agreement. Ivosidenib Letter Agreement In May 2016, we entered into a letter agreement with Celgene regarding ivosidenib, or the Ivosidenib Letter Agreement. Under the Ivosidenib Letter Agreement, the parties agreed to terminate the 2010 Agreement, effective as of August 15, 2016, as to the program directed to the IDH1 target, for which ivosidenib is the lead development candidate. Under the 2010 Agreement, Celgene had held development and commercialization rights to the IDH1 program outside of the United States, and we held such rights inside the United States. As a result of the termination, we obtained global rights to ivosidenib and the IDH1 program. Neither party will have any further financial obligation, including royalties or milestone payments, to the other concerning ivosidenib or the IDH1 program. Under the terms of the termination, the parties also agreed to conduct specified transitional activities in connection with the termination. In addition, pursuant to the Ivosidenib Letter Agreement, the parties are released from their exclusivity obligations under the 2010 Agreement with respect to the IDH1 program. The termination did not affect the AG-881 Agreements, which were directed to both the IDH1 target and the isocitrate dehydrogenase 2, or IDH2, target, and were subsequently terminated in September 2018 as discussed below. Termination of AG-881 Agreements In September 2018, we and Celgene agreed to terminate the AG-881 Agreements effective as of September 4, 2018. From and after September 4, 2018, we obtained sole global rights to AG-881. Neither we nor Celgene will have any further financial obligation under the AG-881 Agreements, including milestones, royalties or other payments, except that (a) Celgene shall be eligible to receive royalties from us at a low single-digit percentage rate on worldwide net sales of products containing AG-881 and (b) we and Celgene shall split certain agreed-upon worldwide development costs for AG-881 until December 31, 2018. In addition, for a specified period and subject to specified exceptions, Celgene and its affiliates shall be prohibited from developing, manufacturing or commercializing any product that inhibits IDH1 at specified levels of binding for any indication and we shall be prohibited from developing, manufacturing or commercializing AG-881 in hematologic indications. 2010 Agreement In April 2010, we entered into the 2010 Agreement, which was amended in October 2011 and July 2014. The goal of the collaboration was to discover, develop and commercialize disease-altering therapies in oncology based on our cancer metabolism research platform. We initially led discovery, preclinical and early clinical development for all cancer metabolism programs under the collaboration. The discovery phase of the 2010 Agreement expired in April 2016. Upon agreement to terminate the 2010 Agreement, effective as of August 15, 2016, as to the program directed to the IDH1 target, for which ivosidenib is the lead development candidate, 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. We have exercised our right to participate in a portion of commercialization activities in the United States for IDHIFA® in accordance with the applicable commercialization plan. On August 1, 2017, the FDA granted Celgene approval of IDHIFA® for the treatment of adult patients with R/R AML with an IDH2 mutation as detected by an FDA-approved test. 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. Under the 2010 Agreement, we receive royalties at tiered, low-double digit to mid-teen percentage rates on net sales of IDHIFA®. Unless terminated earlier by either party, the term of the 2010 Agreement will continue until the expiration of all royalty terms with respect to IDHIFA®. Celgene may terminate this agreement for convenience in its entirety upon ninety days written notice to us. If either party is in material breach and fails to cure such breach within the specified cure period, the other party may terminate the 2010 Agreement in its entirety. Either party may terminate the agreement in the event of specified insolvency events involving the other party. Accounting analysis and revenue recognition – collaboration revenue On January 1, 2018 we adopted ASC 606 under the modified retrospective method. Prior to January 1, 2018 we accounted for the Collaboration Agreements under ASC 605-25, Multiple Element Arrangements. Accounting under ASC 606 In adopting ASC 606, we applied the practical expedient that permits aggregating the effect of all contract modifications that occurred prior to January 1, 2018. No other practical expedients were used. Similar to the accounting under ASC 605-25, the 2016 Agreement was determined to be a modification of the 2010 Agreement and the AG-881 Agreements. In determining the appropriate amount of revenue to be recognized under ASC 606, 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. As part of the accounting for these arrangements, we must develop assumptions that require judgment to determine the stand-alone selling price, or SSP, for each performance obligation identified in the contract. We use key assumptions to determine the SSP, which include forecast of revenues, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical and regulatory success. The satisfied and unsatisfied performance obligations at the time of the ASC 606 adoption, each of which are considered by us to be distinct within the context of the contract, their SSP, the method of recognizing the allocated consideration, and the period through which they are expected to be recognized are as follows: Performance Obligations SSP No. of Performance Obligation(s) Recognition Method Fully satisfied at time of adoption Licenses (1) $86.7 million 4 Fully satisfied; recognized upon adoption of ASC 606 Research and development services (2) $350.7 million 10 Fully satisfied; recognized upon adoption of ASC 606 Partially satisfied at time of adoption Research and development services (2) $266.6 million 6 Proportionally as services are delivered over the performance period, expected to be through September 2022 (3) (1) The SSP was developed by probability weighting multiple cash flow scenarios using the income approach. Our management estimates within the models include the expected, probability-weighted net profits from estimated future sales, an estimate of the direct cost incurred to generate future cash flows, a discount rate and other business forecast factors. There are significant judgments and estimates inherent in the determination of the SSP of these units of accounting. These judgments and estimates include assumptions regarding future operating performance, the timelines of the clinical trials and regulatory approvals, and other factors. If different reasonable assumptions are utilized, the SSP and revenue recognized would vary. (2) The SSP was developed using our management’s best estimate of the cost of obtaining these services at arm’s length from a third-party provider and using internal full time equivalent costs to support the development services. (3) We determined that recognizing revenue on a proportional basis using the ratio of effort incurred to date compared to the total estimated effort required to complete the performance obligation best depicts the satisfaction of our obligations under the Collaboration Agreements. During the three and nine months ended September 30, 2018, we recognized the following as collaboration revenue (in thousands): Three Months Ended September 30, 2018 Nine Months Ended September 30, 2018 Performance Obligation Under Topic Under Topic Effect of Under Topic Under Topic Effect of Collaboration revenue - related party Licenses $ — $ — $ — $ 15,000 $ 15,000 $ — Research and development services 7,504 8,864 (1,360) 23,698 27,184 (3,486) Committee participation — 45 (45) — 132 (132) Reduction of research and development expenses Development services — 847 (847) — 2,911 (2,911) During the three and nine months ended September 30, 2018 and 2017, we recognized as collaboration revenue the following non-contingent consideration allocated to each performance obligation (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2018 2017 2018 2017 Licenses $ — $ — $ 15,000 $ — On-going research and development services 7,504 9,708 23,698 30,374 Committee participation — 41 — 124 Consideration for development and commercialization services performed by us, that were not considered performance obligations as of the modification dates, are recognized as collaboration revenue or a reduction of research and development expenses in the period in which they are earned. There was no impact from the adoption of ASC 606 on these obligations. For the three and nine months ended September 30, 2018 and 2017, we recognized the following collaboration revenue and reduction of research and development expenses related to such expenses (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2018 2017 2018 2017 Collaboration revenue - related party Development activities $ 312 $ — $ 902 $ — Commercialization activities 916 894 2,878 1,999 Reduction of research and development expenses Research and development activities — — — 14 For the three and nine months ended September 30, 2018 and 2017, we recognized the following totals of collaboration revenue and reduction of research and development expenses (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2018 2017 2018 2017 Collaboration revenue - related party $ 8,732 $ 10,643 $ 42,478 $ 32,497 Reduction of research and development expenses — 1,078 — 6,343 The following table presents changes in our contract assets and liabilities during the nine months ended September 30, 2018 (in thousands): December 31, 2017 Additions Deductions September 30, 2018 Contract assets (1) Collaboration receivable – related party $ 2,448 $ 26,233 $ (25,286) $ 3,395 Royalty receivable – related party 1,222 4,853 (4,212) 1,863 Contract liabilities (2) Deferred revenue – related party, current and net of current portions 163,640 7,976 (63,181) 108,435 (1) Additions to contract assets relate to amounts billed to Celgene for reimbursable costs incurred by us during the reporting period. Deductions to contract assets relate to collection of receivables during the reporting period. (2) Additions to contract liabilities relate to consideration from Celgene during the reporting period. Deductions to contract liabilities relate to deferred revenue recognized as revenue during the reporting period and the cumulative catch-up adjustment recognized upon adoption of ASC 606 on January 1, 2018. During the three and nine months ended September 30, 2018, we recognized the following as revenue due to changes in the contract liability balances (in thousands): September 30, 2018 Three Months Ended Nine Months Ended Amounts included in the contract liability at the beginning of the period $ 7,555 $ 23,472 Performance obligations satisfied in previous periods 219 762 As of September 30, 2018, the aggregate amount of the transaction price allocated to performance obligations that are partially unsatisfied was $115.9 million. We consider the total consideration expected to be earned in the next twelve months for services to be performed as current deferred revenue, and consideration that is expected to be earned subsequent to twelve months from the balance sheet date as non-current deferred revenue. Accounting analysis and revenue recognition – 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). 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 and nine months ended September 30, 2018 and 2017, we recognized the following as royalty revenue (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2018 2017 2018 2017 Royalty revenue – related party $ 2,001 $ 715 $ 4,991 $ 715 Accounting analysis and revenue recognition – 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 not considered probable of being achieved and are excluded from the transaction price until those approvals are received. During the three months ended June 30, 2018, Celgene submitted an MAA to the EMA for IDHIFA® for IDH2 mutant-positive R/R AML. As a result of the filing, we determined that a $15.0 million milestone payment for filing of a first new drug application equivalent in an ex-U.S. country was considered probable of being reached as of June 30, 2018 and a significant reversal of revenue would not occur in future periods. As the underlying performance obligation, or delivery of the license to enasidenib, had been satisfied as of June 2014, the milestone payment was recognized in full as collaboration revenue during the three months ended June 30, 2018. No other milestones were achieved during the three months ended September 30, 2018 and three and nine months ended September 30, 2017. The next potential milestone expected to be achieved under our collaboration agreements with Celgene is the first regulatory approval in any of China, Japan or a major European country. Achievement of this event will result in milestone payment of $35.0 million under the 2010 Agreement. CStone Pharmaceuticals In June 2018, we entered into an exclusive license agreement with CStone, 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. We retain development and commercialization rights for the rest of the world. Pursuant to the CStone Agreement, CStone will initially be responsible for the development and commercialization of ivosidenib in AML, cholangiocarcinoma, and, at our discretion, brain cancer indications. Under the terms of 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 $412.0 million in milestone payments upon the achievement of certain development, regulatory and sales milestone events. Approximately half of the milestone payments are related to the development and commercialization of ivosidenib in AML, cholangiocarcinoma and the other half of the milestone payments are related to brain cancer indications, including glioma. We will also be entitled to receive tiered royalties, ranging from 15% to 19% percent, on annual net sales, if any, of ivosidenib. CStone is responsible for all costs it incurs in developing, obtaining regulatory approval of, and commercializing ivosidenib in China, Hong Kong, Macau, and Taiwan, as well as certain costs incurred by us. During the term of the CStone Agreement, each party and its affiliates are prohibited from developing or commercializing any other compound or product that inhibits IDH1 mutations at specified levels of binding, in the case of CStone, anywhere in the world, and in our case, in China, Hong Kong, Macau, and Taiwan. Termination Unless earlier terminated, the CStone Agreement will expire upon the expiration of the last royalty term for the last licensed product within the scope of the CStone Agreement. At any time after CStone has obtained regulatory approval in mainland China in R/R AML and the last patient has been enrolled in a specified clinical trial (or, if earlier, at any time that CStone acquires or is acquired by an entity with a competing or restricted product), CStone may terminate the CStone Agreement in its entirety by providing us with prior written notice. Either party may, subject to specified cure periods, terminate the CStone Agreement in the event of the other party’s uncured material breach. Either party may terminate the CStone Agreement under specified circumstances relating to the other party’s insolvency. We have the right to terminate the CStone Agreement immediately if CStone or its affiliates or sublicensees or subcontractors challenges the validity, patentability, or enforceability of certain patent rights that relate to ivosidenib and are owned by or licensed to us or our affiliates. Accounting analysis and revenue recognition - collaboration revenue The CStone Agreement was determined to be within the scope of ASC 606. Accordingly, 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. As part of the accounting for the CStone Agreement, we developed assumptions that require judgment to determine the SSP for each performance obligation identified in the contract. We use key assumptions to determine the SSP, which include forecast of revenues, development timelines, reimbursement rates, discount rates and probabilities of technical and regulatory success. The satisfied and unsatisfied performance obligations, each of which are considered by us to be distinct within the context of the contract, their SSP, the method of recognizing the allocated consideration, and the period through which they are expected to be recognized are as follows: Performance Obligations SSP No. of Performance Recognition Method License (1) $16.4 million 1 Fully satisfied; recognized upon execution of CStone Agreement Development service (2) $1.7 million 1 Proportionally as services are delivered over the performance period, expected to be through September 2020 (3) (1) The SSP was developed by probability weighting multiple cash flow scenarios using the income approach. Our management estimates within the models include the expected, probability-weighted net profits from estimated future sales, an estimate of the direct costs incurred to generate future cash flows, a discount rate and other business forecast factors. There are significant judgments and estimates inherent in the determination of the SSP of these units of accounting. These judgments and estimates include assumptions regarding future operating performance, the timelines of the clinical trials and regulatory approvals, and other factors. If different reasonable assumptions are utilized, the SSP and revenue recognized would vary. (2) The SSP was developed using our management’s best estimate of the cost of obtaining these services at arm’s length from a third-party provider. (3) We determined that recognizing revenue on a proportional basis using the ratio of effort incurred to date compared to the total estimated effort required to complete the performance obligation best depicts the satisfaction of our obligations under the CStone Agreement. During the three and nine months ended September 30, 2018, we recognized as collaboration revenue the following non-contingent consideration allocated to each performance obligation (in thousan |
Share-Based Payments
Share-Based Payments | 9 Months Ended |
Sep. 30, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [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. 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 remained outstanding and effective. As of September 30, 2018, the total number of shares reserved under the 2007 Plan and the 2013 Plan are 8,024,444, and we had 1,918,363 shares available for future issuance under the 2013 Plan. Stock options The following table presents stock option activity for the nine months ended September 30, 2018: Number of Weighted-Average Exercise Price Outstanding at December 31, 2017 5,577,562 $ 49.58 Granted 1,293,020 78.35 Exercised (1,078,290) 24.13 Forfeited/Expired (306,978) 76.15 Outstanding at September 30, 2018 5,485,314 $ 59.88 Exercisable at September 30, 2018 2,774,270 $ 54.67 Vested and expected to vest at September 30, 2018 5,485,314 $ 59.88 At September 30, 2018, the total unrecognized compensation expense related to unvested stock option awards was $107.4 million, 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 nine months ended September 30, 2018: Number of Weighted-Average Grant Date Fair Value Unvested shares at December 31, 2017 125,584 $ 47.46 Granted 409,896 78.89 Vested (57,250) 41.76 Forfeited (24,494) 70.89 Unvested shares at September 30, 2018 453,736 $ 75.31 As of September 30, 2018, there was approximately $25.1 million of total unrecognized compensation expense related to RSUs, which we expect to be recognized over a weighted-average period of approximately 2.1 years. Performance-based stock units The following table presents PSU activity for the nine months ended September 30, 2018: Number of Weighted-Average Grant Date Fair Value Unvested shares at December 31, 2017 176,186 $ 52.98 Granted — — Vested — — Forfeited (9,155) 64.44 Unvested shares at September 30, 2018 167,031 $ 52.36 As of September 30, 2018, there was approximately $1.1 million of total unrecognized compensation expense related to PSUs, which we expect to be recognized over a weighted-average period of approximately 0.3 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 53,255 shares and 59,651 shares during the nine months ended September 30, 2018 and 2017, respectively, under the 2013 ESPP. The 2013 ESPP provides participating employees with the opportunity to purchase up to an aggregate of 327,272 shares of our common stock. As of September 30, 2018, we had 160,536 shares 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 (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2018 2017 2018 2017 Stock options $ 12,953 $ 11,330 $ 38,736 $ 32,315 Restricted stock units 3,338 634 7,940 2,104 Performance-based stock units 7,656 — 7,656 — Employee stock purchase plan 246 243 838 709 Total stock-based compensation expense $ 24,193 $ 12,207 $ 55,170 $ 35,128 Expenses related to equity-based awards were allocated as follows in the condensed consolidated statements of operations (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2018 2017 2018 2017 Research and development expense $ 13,399 $ 7,620 $ 31,706 $ 22,835 Sales, general and administrative expense 10,794 4,587 23,464 12,293 Total stock-based compensation expense $ 24,193 $ 12,207 $ 55,170 $ 35,128 |
Loss per Share
Loss per Share | 9 Months Ended |
Sep. 30, 2018 | |
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 for which the performance vesting conditions have been met, and ESPP options are 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 and Nine Months Ended September 30, 2018 2017 Stock options 5,485,314 5,820,611 Restricted stock units 453,736 120,000 Performance-based stock units 167,031 — Employee stock purchase plan 5,332 5,348 Total common stock equivalents 6,111,413 5,945,959 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies and Recent Accounting Pronouncements (Policies) | 9 Months Ended |
Sep. 30, 2018 | |
Accounting Policies [Abstract] | |
Basis of presentation | Basis of presentation The condensed consolidated balance sheet as of September 30, 2018, the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2018 and 2017, and cash flows for the nine months ended September 30, 2018 and 2017 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 September 30, 2018, our results of operations for the three and nine months ended September 30, 2018 and 2017, and cash flows for the nine months ended September 30, 2018 and 2017. The financial data and the other financial information disclosed in these notes to the condensed consolidated financial statements related to the three and nine-month period are also unaudited. The results of operations for the three and nine months ended September 30, 2018 are not necessarily indicative of the results to be expected for the year ending December 31, 2018 or for any other future annual or interim period. The year-end condensed consolidated balance sheet data 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. Accordingly, 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, 2017 that was filed with the Securities and Exchange Commission, or the SEC, on February 14, 2018. Our condensed consolidated financial statements include our accounts and the accounts of our wholly owned subsidiaries, Agios Securities Corporation, Agios International Sarl, and Agios Limited. All intercompany transactions have been eliminated in consolidation. The condensed consolidated financial statements have been prepared in conformity with U.S. GAAP. |
Accounts receivable, net | Accounts receivable, net Our trade accounts receivable arise from product sales and represent amounts due from specialty distributors and specialty pharmacy providers in the U.S. We monitor the financial performance and creditworthiness of our customers so that we can |
Concentrations of credit risk | Concentrations of credit risk Financial instruments which potentially subject us to credit risk consist primarily of cash, cash equivalents, and marketable securities. We hold these investments in highly rated financial institutions, and, by policy, limit the amounts of credit exposure to any one financial institution. These amounts at times may exceed federally insured limits. We have not experienced any credit losses in such accounts and do not believe we are exposed to any significant credit risk on these funds. We have no off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts, option contracts, or other hedging arrangements. We are also subject to credit risk on our receivables, including trade receivables from our customers and collaboration and royalty receivables from Celgene Corporation, or Celgene, and CStone Pharmaceuticals, or CStone. Concentrations of credit risk with respect to receivables, which are typically unsecured, are somewhat mitigated due to the number of customers using our products. Our trade receivables arise from product sales in the U.S. and have standard payment terms that generally require payment within 30 to 60 days. We have evaluated the creditworthiness of our customers, including Celgene, and determined them to be creditworthy. To date we have not experienced any losses with respect to our receivables. |
Inventory | Inventory Inventory is stated at the lower of cost or estimated net realizable value on a first-in, first-out basis. Prior to the regulatory approval of our product candidates, we incur expenses for the manufacture of drug product that could potentially be available to support the commercial launch of those products. Until the date at which regulatory approval has been received or is otherwise considered probable, we record all such costs as research and development expenses. Our wholly owned product, TIBSOVO® (ivosidenib), received approval from the U.S. Food and Drug Administration, or FDA, on July 20, 2018 for the treatment of adult patients with relapsed or refractory acute myeloid leukemia, or R/R AML, with susceptible isocitrate dehydrogenase 1, or IDH1, mutation as detected by an FDA-approved test, and we began to capitalize inventories of TIBSOVO® beginning on July 20, 2018. We perform an assessment of the recoverability of capitalized inventory during each reporting period and write down any excess and obsolete inventory to its estimated net realizable value in the period in which the impairment is first identified. Such impairment charges, should they occur, are recorded as a component of cost of sales in the condensed consolidated statements of operations. The determination of whether inventory costs will be realizable requires the use of estimates by management. If actual market conditions are less favorable than projected by management, additional write-downs of inventory may be required. |
Cost of Sales | Cost of Sales Cost of sales consists primarily of manufacturing costs of TIBSOVO ® . Based on our policy to expense costs associated with the manufacturing of our products prior to regulatory approval, certain of the manufacturing costs associated with product shipments of TIBSOVO® recorded |
Recent accounting pronouncements | Recent accounting pronouncements In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842), which was codified as ASC 842, Leases , and amended through subsequent ASUs. We are in the process of reviewing our existing lease contracts and continue to evaluate the accounting implications of ASC 842. We will adopt the guidance effective January 1, 2019 using the modified retrospective transition approach and we expect to elect the package of practical expedients, both provided for under ASU No. 2018-11, Leases (Topic 842): Targeted Improvements . The package of practical expedients allows us not to reassess whether contracts are or contain leases, lease classification, and whether initial direct costs qualify for capitalization. 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. 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, with unrealized gains and losses included as a component of accumulated other comprehensive loss in stockholders’ equity and a component of total comprehensive loss in the condensed consolidated statements of |
Product Revenue | 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. 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. |
Collaboration Revenue | On January 1, 2018 we adopted ASC 606 under the modified retrospective method. Prior to January 1, 2018 we accounted for the Collaboration Agreements under ASC 605-25, Multiple Element Arrangements. Accounting under ASC 606 In adopting ASC 606, we applied the practical expedient that permits aggregating the effect of all contract modifications that occurred prior to January 1, 2018. No other practical expedients were used. Similar to the accounting under ASC 605-25, the 2016 Agreement was determined to be a modification of the 2010 Agreement and the AG-881 Agreements. In determining the appropriate amount of revenue to be recognized under ASC 606, 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. As part of the accounting for these arrangements, we must develop assumptions that require judgment to determine the stand-alone selling price, or SSP, for each performance obligation identified in the contract. We use key assumptions to determine the SSP, which include forecast of revenues, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical and regulatory success. |
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 for which the performance vesting conditions have been met, and ESPP options are considered to be common stock equivalents. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies and Recent Accounting Pronouncements (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Accounting Policies [Abstract] | |
Schedule of Impact of New Accounting Pronouncements | Upon finalization of our assessment, which resulted in changes to our estimates as of December 31, 2017, the impact of the cumulative effect of the accounting changes upon the adoption of the standard (in thousands) is as follows: December 31, 2017 Cumulative Effect January 1, 2018 Deferred revenue – related party, current and net of current portions $ 163,640 $ (39,456) $ 124,184 Accumulated deficit (798,061) 39,456 (758,605) The following tables summarize the effects of adopting ASC 606 on our unaudited condensed consolidated financial statements (in thousands, except per share data): Condensed Consolidated Balance Sheets September 30, 2018 Under Topic Under Topic Effect of Accounts receivable, net $ 2,631 $ 2,631 $ — Collaboration receivable – related party 3,395 3,395 — Collaboration receivable – other 440 — 440 Total current assets 695,542 695,102 440 Total assets 929,079 928,639 440 Deferred revenue – related party 42,141 33,648 8,493 Total current liabilities 84,746 76,253 8,493 Deferred revenue, net of current portion – related party 66,294 107,714 (41,420) Total liabilities 168,866 201,793 (32,927) Accumulated deficit (1,012,839) (1,046,206) 33,367 Total stockholders’ equity 760,213 726,846 33,367 Total liabilities and stockholders’ equity 929,079 928,639 440 Condensed Consolidated Statements of Operations Three Months Ended September 30, 2018 Nine Months Ended September 30, 2018 Under Topic Under Topic Effect of Under Topic Under Topic Effect of Product revenue, net $ 4,465 $ 4,465 $ — $ 4,465 $ 4,465 $ — Collaboration revenue – related party 8,732 10,137 (1,405) 42,478 46,096 (3,618) Collaboration revenue – other — — — 12,440 12,000 440 Research and development expense 82,561 81,714 847 247,515 244,604 2,911 Total cost and expenses 114,360 113,513 847 330,497 327,586 2,911 Loss from operations (99,162) (96,910) (2,252) (266,123) (260,034) (6,089) Net loss (94,664) (92,412) (2,252) (254,234) (248,145) (6,089) Net loss per share – basic and diluted (1.63) (1.59) (0.04) (4.45) (4.34) (0.11) Condensed Consolidated Statements of Comprehensive Loss Three Months Ended September 30, 2018 Nine Months Ended September 30, 2018 Under Topic Under Topic Effect of Under Topic Under Topic Effect of Net loss $ (94,664) $ (92,412) $ (2,252) $ (254,234) $ (248,145) $ (6,089) Comprehensive loss (94,385) (92,133) (2,252) (254,964) (248,875) (6,089) Condensed Consolidated Statements of Cash Flows Nine Months Ended September 30, 2018 Under Topic Under Topic Effect of Net loss $ (254,234) $ (248,145) $ (6,089) Adjustments to reconcile net loss to net cash used in operating activities: Accounts receivable, net (2,631) (2,631) — Collaboration receivable – related party (947) (947) — Collaboration receivable – other (440) — (440) Deferred revenue – related party (15,749) (22,278) 6,529 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
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 September 30, 2018 (in thousands): Level 1 Level 2 Level 3 Total Cash equivalents $ 129,123 $ 24,001 $ — $ 153,124 Marketable securities: Certificates of deposit — 954 — 954 U.S. Treasuries — 266,119 — 266,119 Government securities — 114,407 — 114,407 Corporate debt securities — 340,442 — 340,442 Total cash equivalents and marketable securities $ 129,123 $ 745,923 $ — $ 875,046 |
Marketable Securities (Tables)
Marketable Securities (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Marketable Securities | Marketable securities at September 30, 2018 consisted of the following (in thousands): Amortized Unrealized Unrealized Fair Current: Certificates of deposit $ 960 $ — $ (6) $ 954 U.S Treasuries 244,818 — (302) 244,516 Government securities 61,522 — (163) 61,359 Corporate debt securities 206,948 — (363) 206,585 Non-current: Certificates of deposit — — — — U.S Treasuries 21,860 — (257) 21,603 Government securities 53,301 — (253) 53,048 Corporate debt securities 134,632 — (775) 133,857 Total marketable securities $ 724,041 $ — $ (2,119) $ 721,922 Marketable securities at December 31, 2017 consisted of the following (in thousands): Amortized Unrealized Unrealized Fair Current: Certificates of deposit $ 8,081 $ — $ (11) $ 8,070 U.S. Treasuries 113,852 — (119) 113,733 Government securities 44,421 — (57) 44,364 Corporate debt securities 155,222 — (177) 155,045 Non-current: Certificates of deposit 960 — (8) 952 U.S. Treasuries 36,165 — (311) 35,854 Government securities 23,992 — (182) 23,810 Corporate debt securities 83,722 — (524) 83,198 Total marketable securities $ 466,415 $ — $ (1,389) $ 465,026 |
Inventory (Tables)
Inventory (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventory consists of the following (in thousands): September 30, Raw materials $ — Work-in-process 788 Finished goods 75 Total Inventory $ 863 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consist of the following (in thousands): September 30, December 31, Accrued compensation $ 11,748 $ 15,693 Accrued research and development costs 10,535 14,849 Accrued professional fees 2,509 3,140 Accrued other 511 349 Total accrued expenses $ 25,303 $ 34,031 |
Product Revenue (Tables)
Product Revenue (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Revenue from Contract with Customer [Abstract] | |
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 nine months ended September 30, 2018 (in thousands): Contractual Adjustments Government Rebates Returns Total Balance at December 31, 2017 $ — $ — $ — $ — Current provisions relating to sales in the current year 360 135 106 601 Payments/returns relating to sales in the current year (180) — — (180) Balance at September 30, 2018 $ 180 $ 135 $ 106 $ 421 |
Schedule of Revenue Related Reserves | Total revenue-related reserves above, included in our condensed consolidated balance sheets, are summarized as follows (in thousands): September 30, 2018 Reduction of accounts receivable $ 98 Component of accrued expenses 323 Total revenue-related reserves $ 421 |
Schedule of Changes in Contract Assets and Liabilities, Product Revenue | The following table presents changes in our contract assets and liabilities during the nine months ended September 30, 2018 (in thousands): December 31, 2017 Additions Deductions September 30, 2018 Contract assets (1) Accounts receivable, net $ — $ 5,328 $ (2,697) $ 2,631 |
Collaboration and License Agr_2
Collaboration and License Agreements (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Revenue Recognition and Deferred Revenue [Abstract] | |
Schedule of Milestone-Based Payments Associated With 2016 Agreement | We are eligible to receive the following milestone-based payments associated with the 2016 Agreement: Program Milestone Amount 65/35 program in IO field Specified clinical development event $25.0 million 65/35 program in IO field Specified regulatory milestone events Up to $183.8 million 50/50 program in IO field Specified clinical development event $20.0 million 50/50 program in IO field Specified regulatory milestone events Up to $148.8 million I&I field Specified clinical development event $25.0 million I&I field Specified regulatory milestone events Up to $236.3 million I&I field Specified commercial milestone events Up to $125.0 million |
Schedule of Satisfied and Unsatisfied Performance Obligations | The satisfied and unsatisfied performance obligations at the time of the ASC 606 adoption, each of which are considered by us to be distinct within the context of the contract, their SSP, the method of recognizing the allocated consideration, and the period through which they are expected to be recognized are as follows: Performance Obligations SSP No. of Performance Obligation(s) Recognition Method Fully satisfied at time of adoption Licenses (1) $86.7 million 4 Fully satisfied; recognized upon adoption of ASC 606 Research and development services (2) $350.7 million 10 Fully satisfied; recognized upon adoption of ASC 606 Partially satisfied at time of adoption Research and development services (2) $266.6 million 6 Proportionally as services are delivered over the performance period, expected to be through September 2022 (3) (1) The SSP was developed by probability weighting multiple cash flow scenarios using the income approach. Our management estimates within the models include the expected, probability-weighted net profits from estimated future sales, an estimate of the direct cost incurred to generate future cash flows, a discount rate and other business forecast factors. There are significant judgments and estimates inherent in the determination of the SSP of these units of accounting. These judgments and estimates include assumptions regarding future operating performance, the timelines of the clinical trials and regulatory approvals, and other factors. If different reasonable assumptions are utilized, the SSP and revenue recognized would vary. (2) The SSP was developed using our management’s best estimate of the cost of obtaining these services at arm’s length from a third-party provider and using internal full time equivalent costs to support the development services. (3) We determined that recognizing revenue on a proportional basis using the ratio of effort incurred to date compared to the total estimated effort required to complete the performance obligation best depicts the satisfaction of our obligations under the Collaboration Agreements. |
Schedule of Impact of New Accounting Pronouncements, Impact on Collaboration Revenue | During the three and nine months ended September 30, 2018, we recognized the following as collaboration revenue (in thousands): Three Months Ended September 30, 2018 Nine Months Ended September 30, 2018 Performance Obligation Under Topic Under Topic Effect of Under Topic Under Topic Effect of Collaboration revenue - related party Licenses $ — $ — $ — $ 15,000 $ 15,000 $ — Research and development services 7,504 8,864 (1,360) 23,698 27,184 (3,486) Committee participation — 45 (45) — 132 (132) Reduction of research and development expenses Development services — 847 (847) — 2,911 (2,911) |
Summary of Multiple-deliverable Arrangements Revenue, Allocated to Each Performance Obligation | During the three and nine months ended September 30, 2018 and 2017, we recognized as collaboration revenue the following non-contingent consideration allocated to each performance obligation (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2018 2017 2018 2017 Licenses $ — $ — $ 15,000 $ — On-going research and development services 7,504 9,708 23,698 30,374 Committee participation — 41 — 124 |
Summary of Multiple-deliverable Arrangements Revenue | For the three and nine months ended September 30, 2018 and 2017, we recognized the following collaboration revenue and reduction of research and development expenses related to such expenses (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2018 2017 2018 2017 Collaboration revenue - related party Development activities $ 312 $ — $ 902 $ — Commercialization activities 916 894 2,878 1,999 Reduction of research and development expenses Research and development activities — — — 14 For the three and nine months ended September 30, 2018 and 2017, we recognized the following totals of collaboration revenue and reduction of research and development expenses (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2018 2017 2018 2017 Collaboration revenue - related party $ 8,732 $ 10,643 $ 42,478 $ 32,497 Reduction of research and development expenses — 1,078 — 6,343 |
Schedule of Changes in Contract Assets and Liabilities | The following table presents changes in our contract assets and liabilities during the nine months ended September 30, 2018 (in thousands): December 31, 2017 Additions Deductions September 30, 2018 Contract assets (1) Collaboration receivable – related party $ 2,448 $ 26,233 $ (25,286) $ 3,395 Royalty receivable – related party 1,222 4,853 (4,212) 1,863 Contract liabilities (2) Deferred revenue – related party, current and net of current portions 163,640 7,976 (63,181) 108,435 (1) Additions to contract assets relate to amounts billed to Celgene for reimbursable costs incurred by us during the reporting period. Deductions to contract assets relate to collection of receivables during the reporting period. (2) Additions to contract liabilities relate to consideration from Celgene during the reporting period. Deductions to contract liabilities relate to deferred revenue recognized as revenue during the reporting period and the cumulative catch-up adjustment recognized upon adoption of ASC 606 on January 1, 2018. During the three and nine months ended September 30, 2018, we recognized the following as revenue due to changes in the contract liability balances (in thousands): September 30, 2018 Three Months Ended Nine Months Ended Amounts included in the contract liability at the beginning of the period $ 7,555 $ 23,472 Performance obligations satisfied in previous periods 219 762 |
Schedule of Royalty Revenue | During the three and nine months ended September 30, 2018 and 2017, we recognized the following as royalty revenue (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2018 2017 2018 2017 Royalty revenue – related party $ 2,001 $ 715 $ 4,991 $ 715 |
Summary of Performance Obligations, CStone Agreement | The satisfied and unsatisfied performance obligations, each of which are considered by us to be distinct within the context of the contract, their SSP, the method of recognizing the allocated consideration, and the period through which they are expected to be recognized are as follows: Performance Obligations SSP No. of Performance Recognition Method License (1) $16.4 million 1 Fully satisfied; recognized upon execution of CStone Agreement Development service (2) $1.7 million 1 Proportionally as services are delivered over the performance period, expected to be through September 2020 (3) (1) The SSP was developed by probability weighting multiple cash flow scenarios using the income approach. Our management estimates within the models include the expected, probability-weighted net profits from estimated future sales, an estimate of the direct costs incurred to generate future cash flows, a discount rate and other business forecast factors. There are significant judgments and estimates inherent in the determination of the SSP of these units of accounting. These judgments and estimates include assumptions regarding future operating performance, the timelines of the clinical trials and regulatory approvals, and other factors. If different reasonable assumptions are utilized, the SSP and revenue recognized would vary. (2) The SSP was developed using our management’s best estimate of the cost of obtaining these services at arm’s length from a third-party provider. (3) We determined that recognizing revenue on a proportional basis using the ratio of effort incurred to date compared to the total estimated effort required to complete the performance obligation best depicts the satisfaction of our obligations under the CStone Agreement. |
Summary of Multiple-deliverable Arrangements Revenue, Allocated to Each Performance Obligation, CStone Agreement | During the three and nine months ended September 30, 2018, we recognized as collaboration revenue the following non-contingent consideration allocated to each performance obligation (in thousands): September 30, 2018 Three Months Ended Nine Months Ended Under Topic 606 Under Topic 605 Effect of Change Under Topic 606 Under Topic 605 Effect of Change Collaboration revenue - other License $ — $ — $ — $ 12,440 $ 12,000 $ 440 |
Schedule of Changes in Contract Assets and Liabilities, CStone Agreement | The following table presents changes in our contract assets during the nine months ended September 30, 2018 (in thousands): December 31, 2017 Additions Deductions September 30, 2018 Contract assets (1) Collaboration receivable - other $ — $ 12,440 $ (12,000) $ 440 (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) | 9 Months Ended |
Sep. 30, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Summary of Company's Stock Option Activity | The following table presents stock option activity for the nine months ended September 30, 2018: Number of Weighted-Average Exercise Price Outstanding at December 31, 2017 5,577,562 $ 49.58 Granted 1,293,020 78.35 Exercised (1,078,290) 24.13 Forfeited/Expired (306,978) 76.15 Outstanding at September 30, 2018 5,485,314 $ 59.88 Exercisable at September 30, 2018 2,774,270 $ 54.67 Vested and expected to vest at September 30, 2018 5,485,314 $ 59.88 |
Unvested Stock Unit Activity | The following table presents RSU activity for the nine months ended September 30, 2018: Number of Weighted-Average Grant Date Fair Value Unvested shares at December 31, 2017 125,584 $ 47.46 Granted 409,896 78.89 Vested (57,250) 41.76 Forfeited (24,494) 70.89 Unvested shares at September 30, 2018 453,736 $ 75.31 |
Schedule of Performance-Based Units | The following table presents PSU activity for the nine months ended September 30, 2018: Number of Weighted-Average Grant Date Fair Value Unvested shares at December 31, 2017 176,186 $ 52.98 Granted — — Vested — — Forfeited (9,155) 64.44 Unvested shares at September 30, 2018 167,031 $ 52.36 |
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 (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2018 2017 2018 2017 Stock options $ 12,953 $ 11,330 $ 38,736 $ 32,315 Restricted stock units 3,338 634 7,940 2,104 Performance-based stock units 7,656 — 7,656 — Employee stock purchase plan 246 243 838 709 Total stock-based compensation expense $ 24,193 $ 12,207 $ 55,170 $ 35,128 |
Summary of Allocated Stock-Based Compensation Expense | Expenses related to equity-based awards were allocated as follows in the condensed consolidated statements of operations (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2018 2017 2018 2017 Research and development expense $ 13,399 $ 7,620 $ 31,706 $ 22,835 Sales, general and administrative expense 10,794 4,587 23,464 12,293 Total stock-based compensation expense $ 24,193 $ 12,207 $ 55,170 $ 35,128 |
Loss per Share (Tables)
Loss per Share (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
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 and Nine Months Ended September 30, 2018 2017 Stock options 5,485,314 5,820,611 Restricted stock units 453,736 120,000 Performance-based stock units 167,031 — Employee stock purchase plan 5,332 5,348 Total common stock equivalents 6,111,413 5,945,959 |
Overview and Basis of Present_2
Overview and Basis of Presentation - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 9 Months Ended | |
Jan. 31, 2018 | Sep. 30, 2018 | Sep. 30, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Number of shares issued from public offering (in shares) | 8,152,986 | ||
Offer price (in usd per share) | $ 67 | ||
Proceeds from public offering of common stock, net of commissions | $ 516,200 | $ 516,206 | $ 270,250 |
Cash, cash equivalents, and short-term investments | $ 878,400 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies and Recent Accounting Pronouncements - Impact of the Cumulative Effect of Accounting Changes Upon Adoption of ASC 606 (Details) - USD ($) $ in Thousands | Sep. 30, 2018 | Jan. 01, 2018 | Dec. 31, 2017 |
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||
Deferred revenue – related party, current and net of current portions | $ 124,184 | ||
Accumulated deficit | $ (1,012,839) | (758,605) | $ (798,061) |
Under Topic 605 | |||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||
Deferred revenue – related party, current and net of current portions | 163,640 | ||
Accumulated deficit | (1,046,206) | $ (798,061) | |
Accounting Standards Update 2014-09 | Effect of Change | |||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||
Deferred revenue – related party, current and net of current portions | (39,456) | ||
Accumulated deficit | $ 33,367 | $ 39,456 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies and Recent Accounting Pronouncements - Schedule of Effects of Adopting ASC 606 on Unaudited Balance Sheet (Details) - USD ($) $ in Thousands | Sep. 30, 2018 | Jan. 01, 2018 | Dec. 31, 2017 |
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||
Accounts receivable, net | $ 2,631 | $ 0 | |
Collaboration receivable – related party | 3,395 | 2,448 | |
Collaboration receivable – other | 440 | 0 | |
Total current assets | 695,542 | 445,261 | |
Total assets | 929,079 | 614,397 | |
Deferred revenue – related party | 42,141 | 37,842 | |
Total current liabilities | 84,746 | 94,941 | |
Deferred revenue, net of current portion – related party | 66,294 | 125,798 | |
Total liabilities | 168,866 | 238,894 | |
Accumulated deficit | (1,012,839) | $ (758,605) | (798,061) |
Total stockholders' equity | 760,213 | 375,503 | |
Total liabilities and stockholders’ equity | 929,079 | 614,397 | |
Under Topic 605 | |||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||
Accounts receivable, net | 2,631 | ||
Collaboration receivable – related party | 3,395 | ||
Collaboration receivable – other | 0 | ||
Total current assets | 695,102 | ||
Total assets | 928,639 | ||
Deferred revenue – related party | 33,648 | ||
Total current liabilities | 76,253 | ||
Deferred revenue, net of current portion – related party | 107,714 | ||
Total liabilities | 201,793 | ||
Accumulated deficit | (1,046,206) | $ (798,061) | |
Total stockholders' equity | 726,846 | ||
Total liabilities and stockholders’ equity | 928,639 | ||
Accounting Standards Update 2014-09 | Effect of Change | |||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||
Accounts receivable, net | 0 | ||
Collaboration receivable – related party | 0 | ||
Collaboration receivable – other | 440 | ||
Total current assets | 440 | ||
Total assets | 440 | ||
Deferred revenue – related party | 8,493 | ||
Total current liabilities | 8,493 | ||
Deferred revenue, net of current portion – related party | (41,420) | ||
Total liabilities | (32,927) | ||
Accumulated deficit | 33,367 | $ 39,456 | |
Total stockholders' equity | 33,367 | ||
Total liabilities and stockholders’ equity | $ 440 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies and Recent Accounting Pronouncements - Schedule of Effects of Adopting ASC 606 on Unaudited Statements of Operations (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Revenues | $ 15,198 | $ 11,358 | $ 64,374 | $ 33,212 |
Research and development expense | 82,561 | 72,917 | 247,515 | 215,465 |
Total costs and expenses | 114,360 | 90,375 | 330,497 | 263,876 |
Loss from operations | (99,162) | (79,017) | (266,123) | (230,664) |
Net loss | $ (94,664) | $ (77,137) | $ (254,234) | $ (226,385) |
Net loss per share – basic and diluted (usd per share) | $ (1.63) | $ (1.59) | $ (4.45) | $ (4.94) |
Under Topic 605 | ||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Research and development expense | $ 81,714 | $ 244,604 | ||
Total costs and expenses | 113,513 | 327,586 | ||
Loss from operations | (96,910) | (260,034) | ||
Net loss | $ (92,412) | $ (248,145) | ||
Net loss per share – basic and diluted (usd per share) | $ (1.59) | $ (4.34) | ||
Accounting Standards Update 2014-09 | Effect of Change | ||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Research and development expense | $ 847 | $ 2,911 | ||
Total costs and expenses | 847 | 2,911 | ||
Loss from operations | (2,252) | (6,089) | ||
Net loss | $ (2,252) | $ (6,089) | ||
Net loss per share – basic and diluted (usd per share) | $ (0.04) | $ (0.11) | ||
Product revenue, net | ||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Revenues | $ 4,465 | $ 0 | $ 4,465 | $ 0 |
Product revenue, net | Under Topic 605 | ||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Revenues | 4,465 | 4,465 | ||
Product revenue, net | Accounting Standards Update 2014-09 | Effect of Change | ||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Revenues | 0 | 0 | ||
Collaboration revenue - related party | ||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Revenues | 8,732 | 10,643 | 42,478 | 32,497 |
Collaboration revenue - related party | Under Topic 605 | ||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Revenues | 10,137 | 46,096 | ||
Collaboration revenue - related party | Accounting Standards Update 2014-09 | Effect of Change | ||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Revenues | (1,405) | (3,618) | ||
Collaboration revenue - other | ||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Revenues | 0 | $ 0 | 12,440 | $ 0 |
Collaboration revenue - other | Under Topic 605 | ||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Revenues | 0 | 12,000 | ||
Collaboration revenue - other | Accounting Standards Update 2014-09 | Effect of Change | ||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Revenues | $ 0 | $ 440 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies and Recent Accounting Pronouncements - Schedule of Effects of Adopting ASC 606 on Unaudited Statements of Comprehensive Loss (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Net loss | $ (94,664) | $ (77,137) | $ (254,234) | $ (226,385) |
Comprehensive loss | (94,385) | $ (77,002) | (254,964) | $ (226,587) |
Under Topic 605 | ||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Net loss | (92,412) | (248,145) | ||
Comprehensive loss | (92,133) | (248,875) | ||
Accounting Standards Update 2014-09 | Effect of Change | ||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Net loss | (2,252) | (6,089) | ||
Comprehensive loss | $ (2,252) | $ (6,089) |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies and Recent Accounting Pronouncements - Schedule of Effects of Adopting ASC 606 on Unaudited Statements of Cash Flows (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Net loss | $ (94,664) | $ (77,137) | $ (254,234) | $ (226,385) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||||
Accounts receivable, net | (2,631) | 0 | ||
Collaboration receivable – related party | (947) | 1,397 | ||
Collaboration receivable – other | (440) | 0 | ||
Deferred revenue – related party | (15,749) | (15,749) | $ (20,141) | |
Under Topic 605 | ||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Net loss | (92,412) | (248,145) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||
Accounts receivable, net | (2,631) | |||
Collaboration receivable – related party | (947) | |||
Collaboration receivable – other | 0 | |||
Deferred revenue – related party | (22,278) | |||
Accounting Standards Update 2014-09 | Effect of Change | ||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Net loss | $ (2,252) | (6,089) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||
Accounts receivable, net | 0 | |||
Collaboration receivable – related party | 0 | |||
Collaboration receivable – other | (440) | |||
Deferred revenue – related party | $ 6,529 |
Fair Value Measurements - Cash
Fair Value Measurements - Cash Equivalents and Marketable Securities Measured at Fair Value on a Recurring Basis (Details) - Fair Value, Measurements, Recurring $ in Thousands | Sep. 30, 2018USD ($) |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Cash equivalents | $ 153,124 |
Total cash equivalents and marketable securities | 875,046 |
Certificates of deposit | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Marketable securities | 954 |
U.S. Treasuries | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Marketable securities | 266,119 |
Government securities | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Marketable securities | 114,407 |
Corporate debt securities | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Marketable securities | 340,442 |
Level 1 | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Cash equivalents | 129,123 |
Total cash equivalents and marketable securities | 129,123 |
Level 1 | Certificates of deposit | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Marketable securities | 0 |
Level 1 | U.S. Treasuries | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Marketable securities | 0 |
Level 1 | Government securities | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Marketable securities | 0 |
Level 1 | Corporate debt securities | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Marketable securities | 0 |
Level 2 | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Cash equivalents | 24,001 |
Total cash equivalents and marketable securities | 745,923 |
Level 2 | Certificates of deposit | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Marketable securities | 954 |
Level 2 | U.S. Treasuries | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Marketable securities | 266,119 |
Level 2 | Government securities | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Marketable securities | 114,407 |
Level 2 | Corporate debt securities | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Marketable securities | 340,442 |
Level 3 | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Cash equivalents | 0 |
Total cash equivalents and marketable securities | 0 |
Level 3 | Certificates of deposit | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Marketable securities | 0 |
Level 3 | U.S. Treasuries | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Marketable securities | 0 |
Level 3 | Government securities | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Marketable securities | 0 |
Level 3 | Corporate debt securities | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Marketable securities | $ 0 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) | Sep. 30, 2018USD ($) |
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 | 9 Months Ended | |||
Sep. 30, 2018USD ($)security | Sep. 30, 2017USD ($) | Sep. 30, 2018USD ($)security | Sep. 30, 2017USD ($) | Dec. 31, 2017USD ($)security | |
Schedule of Available-for-sale Securities [Line Items] | |||||
Realized gain (loss) on marketable securities | $ 0 | $ 0 | $ 0 | $ 0 | |
Reclassifications out of accumulated other comprehensive income | $ 0 | $ 0 | $ 0 | $ 0 | |
Established time period for liquidation | 12 months | ||||
Debt securities in an unrealized loss position | security | 236 | 236 | 240 | ||
Aggregate fair value of debt securities in an unrealized loss position | $ 659,800,000 | $ 659,800,000 | $ 439,400,000 | ||
Maximum | |||||
Schedule of Available-for-sale Securities [Line Items] | |||||
Minimum maturity (in years) | 1 year | ||||
Maximum maturity (in years) | 2 years | ||||
Minimum | |||||
Schedule of Available-for-sale Securities [Line Items] | |||||
Minimum maturity (in years) | 1 year |
Marketable Securities - Summary
Marketable Securities - Summary of Marketable Securities (Details) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 724,041 | $ 466,415 |
Unrealized Gains | 0 | 0 |
Unrealized Losses | (2,119) | (1,389) |
Fair Value | 721,922 | 465,026 |
Current: | Certificates of deposit | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 960 | 8,081 |
Unrealized Gains | 0 | 0 |
Unrealized Losses | (6) | (11) |
Fair Value | 954 | 8,070 |
Current: | U.S. Treasuries | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 244,818 | 113,852 |
Unrealized Gains | 0 | 0 |
Unrealized Losses | (302) | (119) |
Fair Value | 244,516 | 113,733 |
Current: | Government securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 61,522 | 44,421 |
Unrealized Gains | 0 | 0 |
Unrealized Losses | (163) | (57) |
Fair Value | 61,359 | 44,364 |
Current: | Corporate debt securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 206,948 | 155,222 |
Unrealized Gains | 0 | 0 |
Unrealized Losses | (363) | (177) |
Fair Value | 206,585 | 155,045 |
Non-current: | Certificates of deposit | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 0 | 960 |
Unrealized Gains | 0 | 0 |
Unrealized Losses | 0 | (8) |
Fair Value | 0 | 952 |
Non-current: | U.S. Treasuries | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 21,860 | 36,165 |
Unrealized Gains | 0 | 0 |
Unrealized Losses | (257) | (311) |
Fair Value | 21,603 | 35,854 |
Non-current: | Government securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 53,301 | 23,992 |
Unrealized Gains | 0 | 0 |
Unrealized Losses | (253) | (182) |
Fair Value | 53,048 | 23,810 |
Non-current: | Corporate debt securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 134,632 | 83,722 |
Unrealized Gains | 0 | 0 |
Unrealized Losses | (775) | (524) |
Fair Value | $ 133,857 | $ 83,198 |
Inventory - Schedule of Invento
Inventory - Schedule of Inventory (Details) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 0 | |
Work-in-process | 788 | |
Finished goods | 75 | |
Total inventory | $ 863 | $ 0 |
Inventory - Additional Informat
Inventory - Additional Information (Details) | 3 Months Ended |
Sep. 30, 2018USD ($) | |
Inventory Disclosure [Abstract] | |
Inventory write-downs | $ 0 |
Accrued Expenses - Summary of A
Accrued Expenses - Summary of Accrued Expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Payables and Accruals [Abstract] | ||
Accrued compensation | $ 11,748 | $ 15,693 |
Accrued research and development costs | 10,535 | 14,849 |
Accrued professional fees | 2,509 | 3,140 |
Accrued other | 511 | 349 |
Total accrued expenses | $ 25,303 | $ 34,031 |
Product Revenue - Additional In
Product Revenue - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Disaggregation of Revenue [Line Items] | ||||
Revenues | $ 15,198 | $ 11,358 | $ 64,374 | $ 33,212 |
Product revenue, net | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | $ 4,465 | $ 0 | $ 4,465 | $ 0 |
Product Revenue - Schedule of P
Product Revenue - Schedule of Product Revenue Allowance and Reserves (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2018USD ($) | |
Contractual Adjustments [Roll Forward] | |
Contract adjustments, beginning balance | $ 0 |
Contractual adjustments, current provisions relating to sales in the current year | 360 |
Contractual adjustments, payments/returns relating to sales in the current year | (180) |
Contract adjustments, ending balance | 180 |
Government Rebates [Roll Forward] | |
Government rebates, beginning balance | 0 |
Government rebates, current provisions relating to sales in the current year | 135 |
Government rebates, payments/returns relating to sales in the current year | 0 |
Government rebates, ending balance | 135 |
Product Returns [Roll Forward] | |
Return reserve, beginning balance | 0 |
Returns, current provisions relating to sales in the current year | 106 |
Returns, payments/returns relating to sales in the current year | 0 |
Return reserve, ending balance | 106 |
Allowance for Doubtful Accounts Receivable [Roll Forward] | |
Total allowances and reserves, beginning balance | 0 |
Total allowances and reserves, current provisions relating to sales in the current year | 601 |
Total allowances and reserves, payments/returns relating to sales in the current year | (180) |
Total allowances and reserves, ending balance | $ 421 |
Product Revenue - Schedule of R
Product Revenue - Schedule of Revenue-Related Reserves (Details) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Revenue from Contract with Customer [Abstract] | ||
Reduction of accounts receivable | $ 98 | |
Component of accrued expenses | 323 | |
Total revenue-related reserves | $ 421 | $ 0 |
Product Revenue - Schedule of C
Product Revenue - Schedule of Changes in Contract Assets and Liabilities, Product Revenue (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2018USD ($) | |
Contract assets | |
Contract assets, beginning balance | $ 0 |
Additions | 5,328 |
Deductions | (2,697) |
Contract assets, ending balance | $ 2,631 |
Collaboration and License Agr_3
Collaboration and License Agreements - 2016 Agreement (Details) - 2016 Agreement | 1 Months Ended |
May 31, 2016extensionprogram | |
Celgene | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Number of research programs that can be designated for continued development after the research term | program | 3 |
Celgene | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Remaining cancer metabolism programs | program | 2 |
Term of agreements | 4 years |
Extension period | extension | 2 |
Number of allowable special case extensions | extension | 4 |
Special case extension term | 1 year |
Collaboration and License Agr_4
Collaboration and License Agreements - Co-Development and Co-Commercialization Agreements (Details) - Co-Development and Co-Commercialization Agreements - Celgene | 1 Months Ended |
May 31, 2016 | |
65/35 Program | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Profit or loss share percentage | 65.00% |
Other Than 65/35 Program | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Profit or loss share percentage | 50.00% |
Collaboration and License Agr_5
Collaboration and License Agreements - Financial Terms (Details) - Celgene - 2016 Agreement | May 17, 2016USD ($) | May 31, 2016USD ($)extension | Mar. 31, 2017USD ($) |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Initial payment received | $ 8,000,000 | $ 200,000,000 | $ 8,000,000 |
Extension period | extension | 2 | ||
Number of allowable special case extensions | extension | 4 | ||
Upfront payment agreement extension fee receivable | $ 40,000,000 | ||
Option exercise fee receivable | 30,000,000 | ||
Additional option exercise fee for further development | 10,000,000 | ||
Minimum | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Minimum option exercise fee receivable for continuation program | $ 35,000,000 |
Collaboration and License Agr_6
Collaboration and License Agreements - Summary of Milestone-based Receivable Payments (Details) - Celgene $ in Millions | May 31, 2016USD ($) |
Specified clinical development event | Co Commercial Agreement | |
Revenue Recognition, Milestone Method [Line Items] | |
Milestone-based receivable payments, eligible to be received | $ 25 |
Specified clinical development event | 65/35 Program | Co-Development and Co-Commercialization Agreements | |
Revenue Recognition, Milestone Method [Line Items] | |
Milestone-based receivable payments, eligible to be received | 25 |
Specified clinical development event | Other Than 65/35 Program | Co-Development and Co-Commercialization Agreements | |
Revenue Recognition, Milestone Method [Line Items] | |
Milestone-based receivable payments, eligible to be received | 20 |
Specified regulatory milestone events | Maximum | Co Commercial Agreement | |
Revenue Recognition, Milestone Method [Line Items] | |
Milestone-based receivable payments, eligible to be received | 236.3 |
Specified regulatory milestone events | Maximum | 65/35 Program | Co-Development and Co-Commercialization Agreements | |
Revenue Recognition, Milestone Method [Line Items] | |
Milestone-based receivable payments, eligible to be received | 183.8 |
Specified regulatory milestone events | Maximum | Other Than 65/35 Program | Co-Development and Co-Commercialization Agreements | |
Revenue Recognition, Milestone Method [Line Items] | |
Milestone-based receivable payments, eligible to be received | 148.8 |
Specified commercial milestone events | Maximum | Co Commercial Agreement | |
Revenue Recognition, Milestone Method [Line Items] | |
Milestone-based receivable payments, eligible to be received | $ 125 |
Collaboration and License Agr_7
Collaboration and License Agreements - AG-881 Agreements (Details) | Sep. 30, 2018USD ($) |
AG-881 program licenses | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Milestone payment for filing of first NDA | $ 35,000,000 |
Collaboration and License Agr_8
Collaboration and License Agreements - 2010 Agreement (Details) - 2010 Agreement $ in Millions | Sep. 30, 2018USD ($) |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Milestone-based receivable payments, eligible to be received | $ 80 |
Milestone payments upon achievement of specified regulatory milestone events | 55 |
Milestone payment upon achievement of a specified commercial milestone event | $ 25 |
Collaboration and License Agr_9
Collaboration and License Agreements - Schedule of Satisfied and Unsatisfied Performance Obligations (Details) $ in Millions | 9 Months Ended |
Sep. 30, 2018USD ($)performance_obligation | |
Licenses | Transferred at Point in Time | |
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |
Stand-alone selling price | $ | $ 86.7 |
No. of Performance Obligation(s) | performance_obligation | 4 |
Research services | Transferred at Point in Time | |
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |
Stand-alone selling price | $ | $ 350.7 |
No. of Performance Obligation(s) | performance_obligation | 10 |
Research services | Transferred over Time | |
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |
Stand-alone selling price | $ | $ 266.6 |
No. of Performance Obligation(s) | performance_obligation | 6 |
Collaboration and License Ag_10
Collaboration and License Agreements - Schedule of Effect of Adopting ASC 606 by Performance Obligation (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Collaboration revenue – related party | $ 8,732 | $ 10,643 | $ 42,478 | $ 32,497 |
Reduction of research and development expenses | 0 | $ 1,078 | 0 | $ 6,343 |
Licenses | ||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Collaboration revenue – related party | 0 | 15,000 | ||
Licenses | Under Topic 605 | Accounting Standards Update 2014-09 | ||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Collaboration revenue – related party | 0 | 15,000 | ||
Licenses | Effect of Change | Accounting Standards Update 2014-09 | ||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Collaboration revenue – related party | 0 | 0 | ||
Research services | ||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Collaboration revenue – related party | 7,504 | 23,698 | ||
Research services | Under Topic 605 | Accounting Standards Update 2014-09 | ||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Collaboration revenue – related party | 8,864 | 27,184 | ||
Research services | Effect of Change | Accounting Standards Update 2014-09 | ||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Collaboration revenue – related party | (1,360) | (3,486) | ||
Committee participation | ||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Collaboration revenue – related party | 0 | 0 | ||
Committee participation | Under Topic 605 | Accounting Standards Update 2014-09 | ||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Collaboration revenue – related party | 45 | 132 | ||
Committee participation | Effect of Change | Accounting Standards Update 2014-09 | ||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Collaboration revenue – related party | (45) | (132) | ||
Development services | ||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Reduction of research and development expenses | 0 | 0 | ||
Development services | Under Topic 605 | Accounting Standards Update 2014-09 | ||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Reduction of research and development expenses | 847 | 2,911 | ||
Development services | Effect of Change | Accounting Standards Update 2014-09 | ||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Reduction of research and development expenses | $ (847) | $ (2,911) |
Collaboration and License Ag_11
Collaboration and License Agreements - Summary of Collaboration Revenue Following Non-Contingent Consideration Allocated to Each Performance Obligation (Details) - Collaborative arrangement, product - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Licenses | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Collaboration revenue – related party | $ 0 | $ 0 | $ 15,000 | $ 0 |
Research services | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Collaboration revenue – related party | 7,504 | 9,708 | 23,698 | 30,374 |
Committee participation | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Collaboration revenue – related party | $ 0 | $ 41 | $ 0 | $ 124 |
Collaboration and License Ag_12
Collaboration and License Agreements - Development and Commercialization Expense Not Contemplated As Part Of Modifications (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Collaboration revenue – related party | $ 8,732 | $ 10,643 | $ 42,478 | $ 32,497 |
Reduction of research and development expenses | 0 | 1,078 | 0 | 6,343 |
Development services | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Reduction of research and development expenses | 0 | 0 | ||
Collaborative arrangement, product | Not Included In Modification Due To High Level Of Uncertainty | Development services | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Collaboration revenue – related party | 312 | 0 | 902 | 0 |
Collaborative arrangement, product | Not Included In Modification Due To High Level Of Uncertainty | Commercialization activities | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Collaboration revenue – related party | 916 | 894 | 2,878 | 1,999 |
Collaborative arrangement, product | Not Included In Modification Due To High Level Of Uncertainty | Research and development activities | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Reduction of research and development expenses | $ 0 | $ 0 | $ 0 | $ 14 |
Collaboration and License Ag_13
Collaboration and License Agreements - Collaboration Revenue and Research and Development Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Revenue Recognition and Deferred Revenue [Abstract] | ||||
Collaboration revenue – related party | $ 8,732 | $ 10,643 | $ 42,478 | $ 32,497 |
Reduction of research and development expenses | $ 0 | $ 1,078 | $ 0 | $ 6,343 |
Collaboration and License Ag_14
Collaboration and License Agreements - Schedule of Changes in Contract Assets and Liabilities (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2018 | Sep. 30, 2018 | |
Contract assets | ||
Contract assets, beginning balance | $ 0 | |
Additions | 5,328 | |
Deductions | (2,697) | |
Contract assets, ending balance | $ 2,631 | 2,631 |
Contract liabilities | ||
Additions | 7,555 | 23,472 |
Collaboration receivable – related party | ||
Contract assets | ||
Contract assets, beginning balance | 2,448 | |
Additions | 26,233 | |
Deductions | (25,286) | |
Contract assets, ending balance | 3,395 | 3,395 |
Royalty receivable – related party | ||
Contract assets | ||
Contract assets, beginning balance | 1,222 | |
Additions | 4,853 | |
Deductions | (4,212) | |
Contract assets, ending balance | 1,863 | 1,863 |
Deferred revenue – related party, current and net of current portions | ||
Contract liabilities | ||
Contract liabilities, beginning balance | 163,640 | |
Additions | 7,976 | |
Deductions | (63,181) | |
Contract liabilities, ending balance | $ 108,435 | $ 108,435 |
Collaboration and License Ag_15
Collaboration and License Agreements - Schedule of Revenues as a Result of Changes in Contract Asset and Contract Liabilities (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2018 | Sep. 30, 2018 | |
Revenue Recognition and Deferred Revenue [Abstract] | ||
Amounts included in the contract liability at the beginning of the period | $ 7,555 | $ 23,472 |
Performance obligations satisfied in previous periods | $ 219 | $ 762 |
Collaboration and License Ag_16
Collaboration and License Agreements - Remaining Unsatisfied Performance Obligations (Details) $ in Millions | Sep. 30, 2018USD ($) |
Revenue Recognition and Deferred Revenue [Abstract] | |
Remaining unsatisfied performance obligation | $ 115.9 |
Collaboration and License Ag_17
Collaboration and License Agreements - Accounting Analysis and Revenue Recognition - Royalty and Milestone Revenue (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Jun. 30, 2018 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Revenues | $ 15,198,000 | $ 11,358,000 | $ 64,374,000 | $ 33,212,000 | |
Milestones achieved | 0 | 0 | 0 | 0 | |
2010 Agreement | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Milestone payment for filing of first NDA | $ 15,000,000 | ||||
AG-881 program licenses | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Milestone payment for filing of first NDA | 35,000,000 | 35,000,000 | |||
Royalty revenue - related party | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Revenues | $ 2,001,000 | $ 715,000 | $ 4,991,000 | $ 715,000 |
Collaboration and License Ag_18
Collaboration and License Agreements - CStone Pharmaceuticals Purchase Agreement (Details) - CStone Pharmaceuticals - CStone Agreement - USD ($) $ in Thousands | 1 Months Ended | |
Jun. 30, 2018 | Sep. 30, 2018 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Initial payment received | $ 12,000 | |
Potential future milestone payments | $ 412,000 | |
Minimum | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Royalty percentage | 15.00% | |
Maximum | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Royalty percentage | 19.00% |
Collaboration and License Ag_19
Collaboration and License Agreements - Satisfied and Unsatisfied Performance Obligations Under CStone Agreement (Details) $ in Millions | 1 Months Ended | 9 Months Ended |
Jun. 30, 2018USD ($)performance_obligation | Sep. 30, 2018USD ($)performance_obligation | |
Licenses | Transferred at Point in Time | ||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||
Stand-alone selling price | $ | $ 86.7 | |
No. of Performance Obligation(s) | performance_obligation | 4 | |
Licenses | Transferred at Point in Time | CStone Agreement | ||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||
Stand-alone selling price | $ | $ 16.4 | |
No. of Performance Obligation(s) | performance_obligation | 1 | |
Development services | Transferred over Time | CStone Agreement | ||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||
Stand-alone selling price | $ | $ 1.7 | |
No. of Performance Obligation(s) | performance_obligation | 1 |
Collaboration and License Ag_20
Collaboration and License Agreements - Collaboration Revenue for Non-Contingent Consideration Allocation to Undelivered Element Under CStone Agreement (Details) - Licenses - CStone Agreement - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2018 | Sep. 30, 2018 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Collaboration revenue – related party | $ 0 | $ 12,440 |
Accounting Standards Update 2014-09 | Under Topic 605 | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Collaboration revenue – related party | 0 | 12,000 |
Accounting Standards Update 2014-09 | Effect of Change | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Collaboration revenue – related party | $ 0 | $ 440 |
Collaboration and License Ag_21
Collaboration and License Agreements - Changes in Contract Assets and Liabilities Under CStone Agreement (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2018USD ($) | |
Contract assets | |
Contract assets, beginning balance | $ 0 |
Additions | 5,328 |
Deductions | (2,697) |
Contract assets, ending balance | 2,631 |
Collaboration receivable – related party | |
Contract assets | |
Contract assets, beginning balance | 2,448 |
Additions | 26,233 |
Deductions | (25,286) |
Contract assets, ending balance | 3,395 |
Collaboration receivable – related party | CStone Agreement | |
Contract assets | |
Contract assets, beginning balance | 0 |
Additions | 12,440 |
Deductions | (12,000) |
Contract assets, ending balance | $ 440 |
Collaboration and License Ag_22
Collaboration and License Agreements - Performance Obligation Revenue and Royalty and Milestone Revenue Under CStone Agreement (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2018 | Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Revenue Recognition and Deferred Revenue [Abstract] | |||||
Revenue from remaining performance obligations under CStone Agreement | $ 1,300,000 | $ 1,300,000 | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Revenues | 15,198,000 | $ 11,358,000 | 64,374,000 | $ 33,212,000 | |
Milestones achieved | 0 | 0 | 0 | 0 | |
CStone Agreement | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Milestones achieved | 0 | 0 | |||
Milestone payment for dosing of first patient | 5,000,000 | 5,000,000 | |||
Royalty revenue - related party | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Revenues | $ 2,001,000 | $ 715,000 | $ 4,991,000 | $ 715,000 | |
Royalty revenue - related party | CStone Agreement | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Revenues | $ 0 |
Collaboration and License Ag_23
Collaboration and License Agreements - Aurigene Discovery Technologies Limited (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
May 31, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Apr. 30, 2017 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Upfront payment | $ 82,561 | $ 72,917 | $ 247,515 | $ 215,465 | ||
Aurigene Discovery Technologies Limited | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Upfront payment | $ 3,000 | |||||
Potential future milestone payments | $ 17,000 | |||||
DHODH Phase One Clinical Trial | Aurigene Discovery Technologies Limited | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Potential future milestone payments | $ 2,000 | $ 2,000 |
Share-Based Payments - Addition
Share-Based Payments - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Compensation expense expected to be recognized | $ 24,193 | $ 12,207 | $ 55,170 | $ 35,128 |
Restricted stock units | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total unrecognized compensation expense related to stock option | 25,100 | 25,100 | ||
Compensation expense expected to be recognized | 3,338 | 634 | $ 7,940 | 2,104 |
Weighted-average period to recognize compensation expense (in years) | 2 years 1 month 6 days | |||
Performance-Based Stock Units (PSUs) | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Compensation expense expected to be recognized | $ 7,656 | $ 0 | $ 7,656 | $ 0 |
Weighted-average period to recognize compensation expense (in years) | 3 months 18 days | |||
2007 Plan and 2013 Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Common stock reserved for issuance (in shares) | 8,024,444 | 8,024,444 | ||
Shares available for future issuance (in shares) | 1,918,363 | 1,918,363 | ||
2013 Stock Incentive Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total unrecognized compensation expense related to stock option | $ 107,400 | $ 107,400 | ||
Weighted-average period to recognize compensation expense (in years) | 2 years 8 months 12 days | |||
2013 Stock Incentive Plan | Performance-Based Stock Units (PSUs) | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total unrecognized compensation expense related to stock option | $ 1,100 | $ 1,100 | ||
2013 Employee Stock Purchase Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares available for future issuance (in shares) | 160,536 | 160,536 | ||
Shares issued under 2013 ESPP (in shares) | 53,255 | 59,651 | ||
Opportunity to purchase of common stock (in shares) | 327,272 |
Share-Based Payments - Summary
Share-Based Payments - Summary of Company's Stock Option Activity (Details) | 9 Months Ended |
Sep. 30, 2018$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward] | |
Number of Stock Options, Outstanding, Beginning balance (in shares) | shares | 5,577,562 |
Number of Stock Options, Granted (in shares) | shares | 1,293,020 |
Number of Stock Options, Exercised (in shares) | shares | (1,078,290) |
Number of Stock Options, Forfeited/Expired (in shares) | shares | (306,978) |
Number of Stock Options, Outstanding, Ending balance (in shares) | shares | 5,485,314 |
Number of Stock Options, Exercisable (in shares) | shares | 2,774,270 |
Number of Stock Options, Vested and expected to vest (in shares) | shares | 5,485,314 |
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 | $ 49.58 |
Weighted-Average Exercise Price, Granted (in usd per share) | $ / shares | 78.35 |
Weighted-Average Exercise Price, Exercised (in usd per share) | $ / shares | 24.13 |
Weighted-Average Exercise Price, Forfeited/Expired (in usd per share) | $ / shares | 76.15 |
Weighted-Average Exercise Price, Outstanding, Ending balance (in usd per share) | $ / shares | 59.88 |
Weighted-Average Exercise Price, Exercisable (in usd per share) | $ / shares | 54.67 |
Weighted-Average Exercise Price, Vested and expected to vest (in usd per share) | $ / shares | $ 59.88 |
Share-Based Payments - Summar_2
Share-Based Payments - Summary of Unvested RSUs Activity (Details) - Restricted stock units | 9 Months Ended |
Sep. 30, 2018$ / 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 | 125,584 |
Granted (in shares) | shares | 409,896 |
Vested (in shares) | shares | (57,250) |
Forfeited/expired (in shares) | shares | (24,494) |
Unvested shares end of period (in shares) | shares | 453,736 |
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 | $ 47.46 |
Weighted-average grant date fair value, Granted (in usd per share) | $ / shares | 78.89 |
Weighted-average grant date fair value, Vested (in usd per share) | $ / shares | 41.76 |
Weighted-average grant date fair value, Forfeited/expired (in usd per share) | $ / shares | 70.89 |
Weighted-average grant date fair value, Unvested shares end of period (in usd per share) | $ / shares | $ 75.31 |
Share-Based Payments - Schedule
Share-Based Payments - Schedule of Performance-Based Units (Details) - Performance-Based Stock Units (PSUs) | 9 Months Ended |
Sep. 30, 2018$ / 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 | 176,186 |
Granted (in shares) | shares | 0 |
Vested (in shares) | shares | 0 |
Forfeited/expired (in shares) | shares | (9,155) |
Unvested shares end of period (in shares) | shares | 167,031 |
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 | $ 52.98 |
Weighted-average grant date fair value, Granted (in usd per share) | $ / shares | 0 |
Weighted-average grant date fair value, Vested (in usd per share) | $ / shares | 0 |
Weighted-average grant date fair value, Forfeited/expired (in usd per share) | $ / shares | 64.44 |
Weighted-average grant date fair value, Unvested shares end of period (in usd per share) | $ / shares | $ 52.36 |
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 | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | $ 24,193 | $ 12,207 | $ 55,170 | $ 35,128 |
Stock options | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 12,953 | 11,330 | 38,736 | 32,315 |
Restricted stock units | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 3,338 | 634 | 7,940 | 2,104 |
Performance-Based Stock Units (PSUs) | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 7,656 | 0 | 7,656 | 0 |
Employee Stock Purchase Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | $ 246 | $ 243 | $ 838 | $ 709 |
Share-Based Payments - Stock-Ba
Share-Based Payments - Stock-Based Compensation Expense for Employee and Non-Employee Stock Options, Restricted Stock Units, Performance-Based Stock Options, Performance-Based Stock Units and Employee Stock Purchase Plan Shares (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | $ 24,193 | $ 12,207 | $ 55,170 | $ 35,128 |
Research and development expense | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 13,399 | 7,620 | 31,706 | 22,835 |
Sales, general and administrative expense | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | $ 10,794 | $ 4,587 | $ 23,464 | $ 12,293 |
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 | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of earnings per share (in shares) | 6,111,413 | 5,945,959 | 6,111,413 | 5,945,959 |
Stock options | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of earnings per share (in shares) | 5,485,314 | 5,820,611 | 5,485,314 | 5,820,611 |
Restricted stock units | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of earnings per share (in shares) | 453,736 | 120,000 | 453,736 | 120,000 |
Performance-Based Stock Units (PSUs) | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of earnings per share (in shares) | 167,031 | 0 | 167,031 | 0 |
Employee stock purchase plan | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of earnings per share (in shares) | 5,332 | 5,348 | 5,332 | 5,348 |