Document And Entity Information
Document And Entity Information - shares | 3 Months Ended | |
Mar. 29, 2019 | Apr. 22, 2019 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 29, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | exel | |
Entity Registrant Name | EXELIXIS, INC. | |
Entity Central Index Key | 0000939767 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Emerging Growth Company | false | |
Entity Small Business | false | |
Current Fiscal Year End Date | --01-03 | |
Entity Common Stock, Shares Outstanding | 301,767,356 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 29, 2019 | Dec. 28, 2018 | [1] |
Current assets: | |||
Cash and cash equivalents | $ 373,937 | $ 314,775 | |
Short-term investments | 425,713 | 378,559 | |
Trade and other receivables | 107,670 | 162,771 | |
Other receivables | 7,445 | 16,056 | |
Inventory, net | 10,143 | 9,838 | |
Unbilled collaboration revenue | 7,244 | 0 | |
Prepaid expenses and other current assets | 14,146 | 15,017 | |
Total current assets | 946,298 | 897,016 | |
Long-term investments | 218,619 | 157,187 | |
Long-term restricted cash and investments | 1,100 | 1,100 | |
Property and equipment, net | 50,553 | 50,897 | |
Operating lease right-of-use assets | 13,921 | 5,867 | |
Deferred tax assets, net | 243,717 | 244,111 | |
Goodwill | 63,684 | 63,684 | |
Other long-term assets | 3,902 | 2,424 | |
Total assets | 1,541,794 | 1,422,286 | |
Current liabilities: | |||
Accounts payable | 9,748 | 10,901 | |
Accrued clinical trial liabilities | 23,055 | 18,231 | |
Accrued compensation and benefits | 22,550 | 32,142 | |
Rebates and fees due to customers | 19,708 | 14,954 | |
Accrued collaboration liabilities | 7,556 | 7,419 | |
Current portion of deferred revenue | 2,376 | 0 | |
Other current liabilities | 40,139 | 21,825 | |
Total current liabilities | 125,132 | 105,472 | |
Long-term portion of lease liabilities | 19,958 | 12,178 | |
Long-term portion of deferred revenue | 8,323 | 15,897 | |
Other long-term liabilities | 3,361 | 1,286 | |
Total liabilities | 156,774 | 134,833 | |
Commitments | |||
Stockholders’ equity | |||
Preferred stock, $0.001 par value, 10,000,000 shares authorized and no shares issued | 0 | 0 | |
Common stock, $0.001 par value; 400,000,000 shares authorized; issued and outstanding: 301,519,885 and 299,876,080 at March 31, 2019 and December 31, 2018, respectively | 302 | 300 | |
Additional paid-in capital | 2,188,578 | 2,168,217 | |
Accumulated other comprehensive income (loss) | 728 | (701) | |
Accumulated deficit | (804,588) | (880,363) | |
Total stockholders’ equity | 1,385,020 | 1,287,453 | |
Total liabilities and stockholders’ equity | $ 1,541,794 | $ 1,422,286 | |
[1] | The Condensed Consolidated Balance Sheet as of December 31, 2018 has been derived from the audited financial statements as of that date. |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 29, 2019 | Dec. 28, 2018 | [1] |
Preferred stock | |||
Par value (in dollars per share) | $ 0.001 | $ 0.001 | |
Shares authorized (in shares) | 10,000,000 | 10,000,000 | |
Shares issued (in shares) | 0 | 0 | |
Common stock | |||
Par value (in dollars per share) | $ 0.001 | $ 0.001 | |
Shares authorized (in shares) | 400,000,000 | 400,000,000 | |
Shares issued (in shares) | 301,519,885 | 299,876,080 | |
Shares outstanding (in shares) | 301,519,885 | 299,876,080 | |
[1] | The Condensed Consolidated Balance Sheet as of December 31, 2018 has been derived from the audited financial statements as of that date. |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Income - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 29, 2019 | Mar. 30, 2018 | |
Total revenues | $ 215,487 | $ 213,719 |
Operating expenses: | ||
Cost of goods sold | 7,501 | 5,639 |
Research and development | 63,289 | 37,757 |
Selling, general and administrative | 60,138 | 54,016 |
Total operating expenses | 130,928 | 97,412 |
Income from operations | 84,559 | 116,307 |
Other income (expense), net: | ||
Interest income | 6,087 | 1,895 |
Other, net | 25 | 169 |
Total other income (expense), net: | 6,112 | 2,064 |
Income before income taxes | 90,671 | 118,371 |
Provision for income taxes | (14,896) | (2,514) |
Net income | $ 75,775 | $ 115,857 |
Net income per share, basic (in dollars per share) | $ 0.25 | $ 0.39 |
Net income per share, diluted (in dollars per share) | $ 0.24 | $ 0.37 |
Shares used in computing net income per share, basic (in shares) | 300,542 | 296,421 |
Shares used in computing net income per share, diluted (in shares) | 314,644 | 313,691 |
Net product revenues | ||
Total revenues | $ 179,581 | $ 134,272 |
Collaboration revenue | ||
Total revenues | $ 35,906 | $ 79,447 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Income - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 29, 2019 | Mar. 30, 2018 | |
Statement of Comprehensive Income [Abstract] | ||
Net income | $ 75,775 | $ 115,857 |
Other comprehensive income (loss): | ||
Net unrealized gains or losses on available-for-sale securities, net of tax impact of $394 and $0, respectively | 1,429 | (540) |
Total other comprehensive income (loss) | 1,429 | (540) |
Comprehensive income | $ 77,204 | $ 115,317 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Comprehensive Income (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 29, 2019 | Mar. 30, 2018 | |
Statement of Comprehensive Income [Abstract] | ||
Unrealized gains or losses on available-for-sale securities, tax impact | $ 394 | $ 0 |
Reclassification adjustments to net income resulting from realized gains or losses on sale of securities | $ 0 | $ 0 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit | |
Balance (in shares) at Dec. 29, 2017 | 296,209,426 | |||||
Balance at Dec. 29, 2017 | $ 284,961 | $ 296 | $ 2,114,184 | $ (347) | $ (1,829,172) | |
Net income | 115,857 | 115,857 | ||||
Other comprehensive income (loss) | (540) | (540) | ||||
Issuance of common stock under equity incentive and stock purchase plans (in shares) | 484,904 | |||||
Issuance of common stock under equity incentive and stock purchase plans | 1,678 | $ 1 | 1,677 | |||
Stock-based compensation | 9,305 | 9,305 | ||||
Balance (in shares) at Mar. 30, 2018 | 296,694,330 | |||||
Balance at Mar. 30, 2018 | $ 669,766 | $ 297 | 2,125,166 | (887) | (1,454,810) | |
Balance (in shares) at Dec. 28, 2018 | 299,876,080 | [1] | 299,876,080 | |||
Balance at Dec. 28, 2018 | $ 1,287,453 | [1] | $ 300 | 2,168,217 | (701) | (880,363) |
Net income | 75,775 | 75,775 | ||||
Other comprehensive income (loss) | 1,429 | 1,429 | ||||
Issuance of common stock under equity incentive and stock purchase plans (in shares) | 1,643,805 | |||||
Issuance of common stock under equity incentive and stock purchase plans | 7,834 | $ 2 | 7,832 | |||
Stock-based compensation | $ 12,529 | 12,529 | ||||
Balance (in shares) at Mar. 29, 2019 | 301,519,885 | 301,519,885 | ||||
Balance at Mar. 29, 2019 | $ 1,385,020 | $ 302 | $ 2,188,578 | $ 728 | $ (804,588) | |
[1] | The Condensed Consolidated Balance Sheet as of December 31, 2018 has been derived from the audited financial statements as of that date. |
Condensed Consolidated Statem_5
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 29, 2019 | Mar. 30, 2018 | ||
Statement of Cash Flows [Abstract] | |||
Net income | $ 75,775 | $ 115,857 | |
Adjustments to reconcile net income (loss) to net cash provided by operating activities: | |||
Depreciation and amortization | 1,962 | 371 | |
Stock-based compensation expense | 12,529 | 9,305 | |
401(k) matching contributions made in common stock | 2,469 | 1,880 | |
Amortization and other right-of-use assets | (7,730) | 0 | |
Gain on other equity investments | 0 | (209) | |
Other | (1,415) | (158) | |
Changes in assets and liabilities: | |||
Trade receivables, net | 55,101 | (10,819) | |
Other receivables | 8,741 | 64 | |
Inventory, net | (305) | (906) | |
Unbilled collaboration revenue | (7,753) | (38,014) | |
Prepaid expenses and other current assets | 871 | 1,900 | |
Other long-term assets | (4,854) | (346) | |
Accounts payable | (1,294) | (183) | |
Accrued compensation and benefits | (9,592) | (317) | |
Accrued clinical trial liabilities | 4,824 | (4,498) | |
Rebates and fees due customers | 4,754 | 4,424 | |
Accrued collaboration liabilities | 137 | (1,000) | |
Current and long-term deferred revenue | (1,313) | (2,652) | |
Long-term portion of lease liabilities | 7,517 | (35) | |
Other current and long-term liabilities | 21,169 | (2,856) | |
Net cash provided by operating activities | 161,593 | 71,808 | |
Cash flows from investing activities: | |||
Purchases of Property and equipment and other, net | (2,307) | (2,947) | |
Purchases of investments | (239,869) | (116,537) | |
Proceeds from maturities of investments | 129,820 | 87,504 | |
Proceeds from sale of investments | 4,699 | 6,238 | |
Proceeds from other equity investments | 0 | 209 | |
Net cash used in investing activities | (107,657) | (25,533) | |
Cash flows from financing activities: | |||
Proceeds from exercise of stock options | 6,817 | 1,875 | |
Taxes paid related to net share settlement of equity awards | (1,580) | (2,129) | |
Principal payments on financing lease obligation | (11) | 0 | |
Net cash provided by (used in) financing activities | 5,226 | (254) | |
Net increase in cash, cash equivalents and restricted cash | 59,162 | 46,021 | |
Cash, cash equivalents and restricted cash at beginning of period | 315,875 | 188,314 | |
Cash, cash equivalents and restricted cash at end of period | 375,037 | 234,335 | |
Supplemental cash flow disclosure | |||
Right-of-use assets obtained in exchange for lease obligations | [1] | 8,170 | 17,180 |
Unpaid liabilities incurred to acquire Property and equipment | $ 141 | $ 6,608 | |
[1] | Amounts for the three months ended March 31, 2019 include receipt of a tenant inventive payment. Amounts for the three months ended March 31, 2018 include the transition adjustment for the adoption of Accounting Standards Codification (ASC) Topic 842, Leases. |
Organization and Summary of Sig
Organization and Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 29, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Organization Exelixis, Inc. (Exelixis, we, our or us) is an oncology-focused biotechnology company that strives to accelerate the discovery, development and commercialization of new medicines for difficult-to-treat cancers. Since we were founded in 1994, four products resulting from our discovery efforts have progressed through clinical development an d received regulatory approval; three have a growing commercial presence in markets worldwide, and we expect that the fourth will soon enter the marketplace in Japan. Two are derived from cabozantinib, an inhibitor of multiple tyrosine kinases including MET, AXL, VEGF receptors and RET. These are: CABOMETYX® (cabozantinib) tablets approved for advanced renal cell carcinoma and previously treated hepatocellular carcinoma and COMETRIQ® (cabozantinib) capsules approved for progressive, metastatic medullary thyroid cancer. The other two products resulting from our discovery efforts are: COTELLIC® (cobimetinib), an inhibitor of MEK, approved as part of a combination regimen to treat a specific form of advanced melanoma and marketed under a collaboration with Genentech, Inc. (a member of the Roche Group) (Genentech); and MINNEBRO™ (esaxerenone), an oral, non-steroidal, selective blocker of the mineralocorticoid receptor, recently approved for the treatment of hypertension in Japan and licensed to Daiichi Sankyo Company, Limited (Daiichi Sankyo). Basis of Consolidation The accompanying Condensed Consolidated Financial Statements include the accounts of Exelixis and those of our wholly-owned subsidiaries. These entities’ functional currency is the U.S. dollar. All intercompany balances and transactions have been eliminated. Basis of Presentation The accompanying unaudited Condensed Consolidated Financial Statements have been prepared in accordance with accounting principles generally accepted in the U.S. for interim financial information and pursuant to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission (SEC). Accordingly, they do not include all of the information and footnotes required by U.S. generally accepted accounting principles for complete financial statements. In our opinion, all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation of our financial statements for the periods presented have been included. We have adopted a 52- or 53-week fiscal year policy that generally ends on the Friday closest to December 31 st . Fiscal year 2019 will end on January 3, 2020 and fiscal year 2018 ended on December 28, 2018. For convenience, references in this report as of and for the fiscal periods ended March 29, 2019 and March 30, 2018, and as of and for the fiscal years ending January 3, 2020 and ended December 28, 2018, are indicated as being as of and for the periods ended March 31, 2019 and March 31, 2018, and the years ending December 31, 2019 and ended December 31, 2018, respectively. Similarly, references in this report to the first day of the fiscal year ended January 3, 2020 are indicated as being as of January 1, 2019. Operating results for the three months ended March 31, 2019 are not necessarily indicative of the results that may be expected for the year ending December 31, 2019 or for any future period. The accompanying Condensed Consolidated Financial Statements and Notes thereto should be read in conjunction with our Consolidated Financial Statements and Notes thereto for the year ended December 31, 2018 , included in our Annual Report on Form 10-K filed with the SEC on February 22, 2019 . Segment Information We operate in one business segment that focuses on the discovery, development and commercialization of new medicines for difficult-to-treat cancers . Our Chief Executive Officer, as the chief operating decision-maker, manages and allocates resources to our operations on a total consolidated basis. Consistent with this decision-making process, our Chief Executive Officer uses consolidated, single-segment financial information for purposes of evaluating performance, forecasting future period financial results, allocating resources and setting incentive targets. All of our long-lived assets are located in the U.S. See “Note 2. Revenues” for enterprise-wide disclosures about product sales, revenues from major customers and revenues by geographic region. Use of Estimates The preparation of the accompanying Condensed Consolidated Financial Statements conforms to accounting principles generally accepted in the U.S., which requires management to make judgments, estimates and assumptions that affect the reported amounts of assets, liabilities, equity, revenues and expenses, and related disclosures. On an ongoing basis, management evaluates its estimates including, but not limited to: those related to revenue recognition, including determining the nature and timing of satisfaction of performance obligations, and determining the standalone selling price of performance obligations, and variable consideration such as rebates, chargebacks, sales returns, sales allowances, and milestone payments included in collaboration arrangements; the amounts of revenues and expenses under our profit and loss sharing agreement; the recoverability of inventory; the amounts of operating lease right-of-use assets and lease liabilities; the amounts of deferred tax assets and liabilities including the related valuation allowance; the accrual for certain liabilities including accrued clinical trial liabilities; and valuations of equity awards used to determine stock-based compensation, including certain awards with vesting subject to market or performance conditions. We base our estimates on historical experience and on various other market-specific and other relevant assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ materially from those estimates. Reclassifications Certain prior period amounts in the accompanying Condensed Consolidated Financial Statements have been reclassified to conform to current period presentation. Total revenues and Selling, general and administrative expenses for the three months ended March 31, 2018 have been adjusted to reflect the reclassification of the $1.4 million profit related to the profit-sharing arrangement with Genentech for the commercialization of COTELLIC. In our Condensed Consolidated Financial Statements included in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2018, the net profit had been classified as Selling, general and administrative expenses as we expected an overall loss under the agreement for the year ended December 31, 2018. Subsequent to March 31, 2018, we determined that the U.S. commercialization of COTELLIC would result in a profit for the year ended December 31, 2018 and therefore, we had reclassified the profit for the three months ended March 31, 2018 from Selling, general and administrative expenses to Collaboration revenues in our financial statements issued after March 31, 2018. Accordingly, we have also reclassified the profit for the three months ended March 31, 2018 in the accompanying Condensed Consolidated Financial Statements to be consistent with our presentation for the year ended December 31, 2018. For more information on our collaboration agreement with Genentech, see “Note 3. Collaboration Agreements” to our Consolidated Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2018 . Recently Adopted Accounting Pronouncements On January 1, 2019, we adopted ASU 2018-02, Income Statement—Reporting Comprehensive Income (Topic 220) (ASU 2018-02). There was no financial impact from the adoption of ASU 2018-02 and we did not make an election to reclassify the income tax effects of the Tax Cuts and Jobs Act of 2017 from Accumulated other comprehensive income (loss) to Accumulated deficit. In connection with the adoption of ASU 2018-02, we have adopted the individual unit of account approach for releasing income tax effects from Accumulated other comprehensive income (loss) . On January 1, 2019, we also adopted ASU 2017-08 , Receivables—Nonrefundable Fees and Other Costs (Subtopic 310-20) (ASU 2017-08). ASU 2017-08 shortens the amortization period for certain callable debt securities held at a premium. Specifically, ASU 2017-08 requires the premium to be amortized to the earliest call date. ASU 2017-08 does not require an accounting change for securities held at a discount; the discount continues to be amortized to maturity. The financial impact from the adoption of ASU 2017-08 was nominal. Recent Accounting Pronouncements Not Yet Adopted In November 2018, the Financial Accounting Standards Board (the FASB) issued ASU No. 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 (ASU 2018-18). ASU 2018-18 clarifies that certain transactions between collaborative arrangement participants should be accounted for as revenue under Topic 606 when the counterparty is a customer for a distinct good or service (i.e. a unit of account). For units of account that are in the scope of Topic 606, all of the guidance in Topic 606 should be applied, including the guidance on recognition, measurement, presentation and disclosure. ASU 2018-18 also adds a reference in Topic 808 to the unit of account guidance in ASC 606 and requires that it be applied only to assess whether transactions in a collaborative arrangement are in the scope of Topic 606. ASU 2018-18 will preclude entities from presenting amounts related to transactions with a counterparty in a collaborative arrangement that is not a customer as revenue from contracts with customers. ASU 2018-18 is effective for us for all interim and annual reporting periods beginning after December 15, 2019. Early adoption is permitted. We are in the process of assessing the impact of ASU 2018-18 on our Condensed Consolidated Financial Statements. In August 2018, the FASB issued ASU No. 2018-15, Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40): Customer's Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract (ASU 2018-15). ASU 2018-15 aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software (and hosting arrangements that include an internal-use software license). Accordingly, ASU 2018-15 requires a customer in a hosting arrangement that is a service contract to follow the guidance in Subtopic 350-40 to determine which implementation costs to capitalize as an asset related to the service contract and which costs to expense. ASU 2018-15 also requires us to expense the capitalized implementation costs of a hosting arrangement that is a service contract over the term of the hosting arrangement, which includes reasonably certain renewals. ASU 2018-15 is effective for us for all interim and annual reporting periods beginning after December 15, 2019. Early adoption is permitted. We are in the process of assessing the impact of ASU 2018-15 on our Condensed Consolidated Financial Statements. In January 2017, the FASB issued ASU No. 2017-04, Intangibles—Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment (ASU 2017-04) . ASU 2017-04 eliminated Step 2 from the goodwill impairment test. Instead, under the amendments in ASU 2017-04, an entity should perform its annual, or interim, goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount. An entity should recognize an impairment charge for the amount by which the carrying amount exceeds the reporting unit’s fair value; however, the loss recognized should not exceed the total amount of goodwill allocated to that reporting unit. Additionally, an entity should consider income tax effects from any tax deductible goodwill on the carrying amount of the reporting unit when measuring the goodwill impairment loss, if applicable. ASU 2017-04 is effective for all interim and annual reporting periods beginning after December 15, 2019. Early adoption is permitted. We do not expect the adoption of ASU 2017-04 to have a material impact on our Condensed Consolidated Financial Statements. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326) (ASU 2016-13) . ASU 2016-13 implements an impairment model, known as the current expected credit loss model, that is based on expected losses rather than incurred losses. Under the new guidance, an entity will recognize as an allowance its estimate of expected credit losses. 2016-13 is effective for all interim and annual reporting periods beginning after December 15, 2019. Early adoption is permitted. We do not expect the adoption of ASU 2016-13 to have a material impact on our Condensed Consolidated Financial Statements. |
Revenues
Revenues | 3 Months Ended |
Mar. 29, 2019 | |
Revenue from Contract with Customer [Abstract] | |
REVENUES | REVENUES Revenues by disaggregated category were as follows (in thousands): Three Months Ended March 31, 2019 2018 Product revenues: Gross product revenues $ 223,750 $ 159,436 Discounts and allowances (44,169 ) (25,164 ) Net product revenues 179,581 134,272 Collaboration revenues: License revenues (1) 24,509 69,030 Research and development service revenues (2) 11,928 10,099 Other collaboration revenues (3) (531 ) 318 Total collaboration revenues 35,906 79,447 Total revenues $ 215,487 $ 213,719 ____________________ (1) License revenues included the immediate recognition of the portion of milestones allocated to the transfer of intellectual property licenses for which it had become probable in the current period that the milestone would be achieved and a significant revenue reversal would not occur, as well as royalty revenues from Ipsen Pharma SAS (Ipsen) and Genentech. (2) Research and development service revenues included the recognition of deferred revenue for the portion of upfront and milestone payments that have been allocated to research and development service performance obligations, as well as development cost reimbursements earned on our collaboration agreements. (3) Other collaboration revenues included the profit on the U.S. commercialization of COTELLIC from Genentech and revenues on product supply services provided to Ipsen and Takeda Pharmaceutical Company Ltd. (Takeda), which were partially offset by the 3% royalty we are required to pay GlaxoSmithKline (GSK) on the net sales by Ipsen of any product incorporating cabozantinib. Net product revenues, License revenues and Research and development services revenues were recorded in accordance with Topic 606 for all periods presented. Net product revenues and License revenues related to goods and intellectual property licenses transferred at a point in time and Research and development services revenues related to services performed over time. Other collaboration revenues, which included the p rofit on the U.S. commercialization of COTELLIC and net losses on product supply services, were recorded in accordance with ASC Topic 808, Collaborative Arrangements for all periods presented . Net product revenues disaggregated by product were as follows (in thousands): Three Months Ended March 31, 2019 2018 CABOMETYX $ 175,890 $ 128,934 COMETRIQ 3,691 5,338 Net product revenues $ 179,581 $ 134,272 Total revenues disaggregated by significant customer were as follows (dollars in thousands): Three Months Ended March 31, 2019 2018 Dollars Percent of total Dollars Percent of total Caremark L.L.C. $ 32,698 15 % $ 26,388 12 % Affiliates of McKesson Corporation 25,311 12 % 21,331 10 % Accredo Health, Incorporated 22,495 10 % 18,286 9 % Affiliates of AmerisourceBergen Corporation 21,902 10 % 15,736 7 % Ipsen 21,868 10 % 53,809 25 % Others, individually less than 10% of Total revenues for all periods presented 91,213 43 % 78,169 37 % Total revenues $ 215,487 100 % $ 213,719 100 % Total revenues disaggregated by geographic region were as follows (in thousands): Three Months Ended March 31, 2019 2018 U.S. $ 182,126 $ 136,993 Europe 21,868 53,809 Rest of the world 11,493 22,917 Total revenues $ 215,487 $ 213,719 Net product revenues are attributed to geographic region based on the ship-to location. Collaboration revenues are attributed to geographic region based on the location of our collaboration partners’ headquarters. Product Sales Discounts and Allowances The activities and ending reserve balances for each significant category of discounts and allowances (which constitute variable consideration) were as follows (in thousands): Chargebacks and Discounts for Prompt Payment Other Customer Credits/Fees and Co-pay Assistance Rebates Returns Total Balance at December 31, 2018 $ 2,322 $ 3,038 $ 11,916 $ — $ 17,276 Provision related to sales made in: Current period 27,153 3,875 12,905 — 43,933 Prior periods — 9 227 — 236 Payments and customer credits issued (27,367 ) (4,189 ) (8,073 ) — (39,629 ) Balance at March 31, 2019 $ 2,108 $ 2,733 $ 16,975 $ — $ 21,816 Chargebacks and discounts for prompt payment are recorded as a reduction of trade receivables and the remaining reserve balances are classified as Other current liabilities in the accompanying Condensed Consolidated Balance Sheets. Contract Assets and Liabilities We receive payments from our licensees based on billing schedules established in each contract. Amounts are recorded as accounts receivable when our right to consideration is unconditional. Upfront and milestone payments may require deferral of revenue recognition to a future period until we perform our obligations under these arrangements and are recorded as deferred revenue upon receipt or when due. We may also recognize revenue in advance of the contractual billing schedule and such amounts are recorded as unbilled collaboration revenue when recognized. Changes in our contract assets and liabilities under Topic 606 were as follows (in thousands): Contract Assets: Unbilled Collaboration Revenue Contract Liabilities: Deferred Revenue Current Portion Long-term Portion Current Portion Long-term Portion Balance at December 31, 2018 $ — $ — $ — $ 15,897 Increases as a result of a change in transaction price and recognition of revenues as services are performed 10,222 1,450 — — Transfer to receivables from contract assets recognized at the beginning of the period (543 ) — — — Increases as a result of the deferral of milestones achieved in period, excluding amounts recognized as revenue — — — — Revenue recognized that was included in the contract liability balance at the beginning of the period — — (1,313 ) — Other adjustments (1) (2,435 ) (1,450 ) 3,689 (7,574 ) Balance at March 31, 2019 $ 7,244 $ — $ 2,376 $ 8,323 ____________________ (1) Includes reclassification of deferred revenue from long-term to current and adjustments made due to netting of contract assets and liabilities by collaboration agreement. During the three months ended March 31, 2019 and 2018 , we recognized $25.3 million and $71.3 million , respectively, in revenues under Topic 606 for performance obligations satisfied in previous periods. Such revenues primarily related to milestone and royalty payments allocated to our license performance obligations of our collaborations with Ipsen, Takeda and Bristol-Myers Squibb Company (BMS). |
Collaboration Agreements
Collaboration Agreements | 3 Months Ended |
Mar. 29, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
COLLABORATION AGREEMENTS | COLLABORATION AGREEMENTS We have established multiple collaborations with leading pharmaceutical companies for the commercialization and further development of cabozantinib, as well as with smaller, discovery-focused biotechnology companies to expand our product pipeline. Additionally, in line with our business strategy prior to the commercialization of our first product, COMETRIQ, we entered into other collaborations with leading pharmaceutical companies including Genentech, Daiichi Sankyo and BMS for other compounds and programs in our portfolio. See “Note 3. Collaboration Agreements” to our Consolidated Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2018 for a description of each of our collaboration agreements. Under these collaborations, we are generally entitled to receive milestone and royalty payments, and for certain collaborations, payments for product supply services, development cost reimbursements, and/or profit-sharing payments. See “Note 2. Revenues” for information on collaboration revenues recognized during the three months ended March 31, 2019 and 2018 . Cabozantinib Commercial Collaborations Ipsen Collaboration In February 2016, we entered into a collaboration and license agreement with Ipsen for the commercialization and further development of cabozantinib. Pursuant to the terms of the collaboration agreement, Ipsen received exclusive commercialization rights for current and potential future cabozantinib indications outside of the U.S., Canada and Japan. The collaboration agreement was subsequently amended in December 2016 to include commercialization rights in Canada. We have also agreed to collaborate with Ipsen on the development of cabozantinib for current and potential future indications. Collaboration revenues under the collaboration agreement with Ipsen were as follows (in thousands): Three Months Ended March 31, 2019 2018 Ipsen collaboration revenues $ 21,868 $ 53,809 As of March 31, 2019 , $46.8 million of the transaction price allocated to our research and development services performance obligation had not been satisfied. As of March 31, 2019 , the net contract liability for the collaboration agreement with Ipsen was $10.7 million , of which 2.4 million was included in the Current portion of deferred revenue and $8.3 million was included in the Long-term portion of deferred revenue in the accompanying Condensed Consolidated Balance Sheets. Takeda Collaboration In January 2017, we entered into a collaboration and license agreement with Takeda. See “Note 11. Subsequent Events - Amendment to Collaboration Agreement with Takeda” for information regarding an amendment to our collaboration agreement with Takeda. Pursuant to this collaboration agreement, Takeda has exclusive commercialization rights for current and potential future cabozantinib indications in Japan, and the parties have agreed to collaborate on the clinical development of cabozantinib in Japan. Collaboration revenues under the collaboration agreement with Takeda were as follows (in thousands): Three Months Ended March 31, 2019 2018 Takeda collaboration revenues $ 11,493 $ 2,917 As of March 31, 2019 , $25.2 million of the transaction price allocated to our research and development services performance obligation had not been satisfied. As of March 31, 2019 , the net contract asset for the collaboration agreement with Takeda was $7.2 million , which was included in Unbilled collaboration revenue in the accompanying Condensed Consolidated Balance Sheets. GlaxoSmithKline (GSK) In October 2002, we established a product development and commercialization collaboration agreement with GSK. Under the terms of the collaboration agreement, GSK had the right to choose cabozantinib for further development and commercialization, but notified us in October 2008 that it had waived its right to select the compound for such activities. Although the collaboration agreement was terminated in December 2014, GSK continues to be entitled to a 3% royalty we are required to pay on all net sales of any product incorporating cabozantinib by us and our collaboration partners. Royalties accruing to GSK in connection with the sales of cabozantinib are included in Cost of goods sold for sales by us and as a reduction of Collaboration revenues for sales by Ipsen. Such royalties accruing to GSK were as follows (in thousands): Three Months Ended March 31, 2019 2018 Royalties accruing to GSK $ 7,282 $ 5,125 Genentech Collaboration In December 2006, we out-licensed the development and commercialization of cobimetinib to Genentech pursuant to a worldwide collaboration agreement. Under the terms of the collaboration agreement, we developed cobimetinib through the determination of the maximum tolerated dose in a phase 1 clinical trial, and Genentech had the option to co-develop cobimetinib, an option that Genentech exercised, and in March 2009, we granted to Genentech an exclusive worldwide revenue-bearing license to cobimetinib, at which point Genentech became responsible for completing the phase 1 clinical trial and the subsequent clinical development. In November 2015, the U.S. Food and Drug Administration approved cobimetinib, under the brand name COTELLIC, in combination with Genentech’s Zelboraf (vemurafenib) as a treatment for patients with BRAF V600E or V600K mutation-positive advanced melanoma. COTELLIC in combination with Zelboraf has also been approved in the European Union and multiple additional countries for use in the same indication. Profits on U.S. commercialization and Royalty revenues on ex-U.S. sales were as follows (in thousands): Three Months Ended March 31, 2019 2018 Profits on U.S. commercialization $ 1,055 $ 1,373 Royalty revenues on ex-U.S. sales $ 1,490 $ 1,349 |
Cash and Investments
Cash and Investments | 3 Months Ended |
Mar. 29, 2019 | |
Investments, Debt and Equity Securities [Abstract] | |
CASH AND INVESTMENTS | CASH AND INVESTMENTS Cash, Cash Equivalents and Restricted Cash A reconciliation of Cash, cash equivalents, and restricted cash reported within our Condensed Consolidated Balance Sheets to the amount reported within the accompanying Condensed Consolidated Statements of Cash Flows was as follows (in thousands): March 31, 2019 December 31, 2018 March 31, 2018 December 31, 2017 Cash and cash equivalents $ 373,937 $ 314,775 $ 232,331 $ 183,164 Restricted cash included in short-term restricted cash and investments — — 504 504 Restricted cash included in long-term restricted cash and investments 1,100 1,100 1,500 4,646 Cash, cash equivalents, and restricted cash as reported within the accompanying Condensed Consolidated Statements of Cash Flows $ 375,037 $ 315,875 $ 234,335 $ 188,314 Restricted cash includes certificates of deposit used to collateralize letters of credit and, in prior periods, a purchasing card program. Cash and Investments Cash and investments by security type were as follows (in thousands): March 31, 2019 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Investments available-for-sale: Money market funds $ 75,171 $ — $ — $ 75,171 Commercial paper 414,317 — — 414,317 Corporate bonds 417,303 1,257 (175 ) 418,385 U.S. Treasury and government sponsored enterprises 84,448 41 (2 ) 84,487 Total investments available-for-sale 991,239 1,298 (177 ) 992,360 Cash and restricted cash 1,019 — — 1,019 Certificates of deposit 25,990 — — 25,990 Total cash and investments $ 1,018,248 $ 1,298 $ (177 ) $ 1,019,369 December 31, 2018 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Investments available-for-sale: Money market funds $ 47,744 $ — $ — $ 47,744 Commercial paper 381,134 — (1 ) 381,133 Corporate bonds 344,741 180 (857 ) 344,064 U.S. Treasury and government sponsored enterprises 55,224 2 (25 ) 55,201 Total investments available-for-sale 828,843 182 (883 ) 828,142 Cash and restricted cash 6,883 — — 6,883 Certificates of deposit 16,596 — — 16,596 Total cash and investments $ 852,322 $ 182 $ (883 ) $ 851,621 Gains and losses on the sales of investments available-for-sale were nominal during the three months ended March 31, 2019 and 2018 . The fair value and gross unrealized losses on investments available-for-sale in an unrealized loss position were as follows (in thousands): March 31, 2019 In an Unrealized Loss Position Less than 12 Months In an Unrealized Loss Position 12 Months or Greater Total Fair Value Gross Fair Value Gross Fair Value Gross Corporate bonds $ 49,233 $ (39 ) $ 45,010 $ (136 ) $ 94,243 $ (175 ) U.S. Treasury and government sponsored enterprises — — 7,990 (2 ) 7,990 (2 ) Total $ 49,233 $ (39 ) $ 53,000 $ (138 ) $ 102,233 $ (177 ) December 31, 2018 In an Unrealized Loss Position Less than 12 Months In an Unrealized Loss Position 12 Months or Greater Total Fair Value Gross Fair Value Gross Fair Value Gross Corporate bonds $ 236,162 $ (606 ) $ 39,627 $ (251 ) $ 275,789 $ (857 ) U.S. Treasury and government sponsored enterprises 28,105 (16 ) 9,182 (9 ) 37,287 (25 ) Commercial paper 7,091 (1 ) — — 7,091 (1 ) Total $ 271,358 $ (623 ) $ 48,809 $ (260 ) $ 320,167 $ (883 ) There were 69 and 199 investments in an unrealized loss position as of March 31, 2019 and December 31, 2018 , respectively. During the three months ended March 31, 2019 and 2018 we did no t record any other-than-temporary impairment charges on our available-for-sale securities. Based upon our quarterly impairment review, we determined that the unrealized losses were not attributed to credit risk, but were primarily associated with changes in interest rates. Based on the scheduled maturities of our investments and our determination that it was more likely than not that we will hold these investments for a period of time sufficient for a recovery of our cost basis, we concluded that the unrealized losses in our investment securities were not other-than-temporary. The fair value of investments available-for-sale by contractual maturity were as follows (in thousands): March 31, December 31, 2018 Maturing in one year or less $ 784,432 $ 674,455 Maturing after one year through five years 207,928 153,687 Total investments available-for-sale $ 992,360 $ 828,142 Related Party Transactions BlackRock, Inc. (BlackRock), a global provider of investment, advisory and risk management solutions, reported that as of December 31, 2018 , the most recent date for which they reported ownership data, their beneficial ownership was more than 10% of our outstanding common stock. BlackRock manages a portion of our cash and investments portfolio. As of March 31, 2019 and December 31, 2018 , respectively, the fair value of cash and investments managed by BlackRock was $356.0 million and $298.5 million , which included $0.8 million and $3.0 million invested in the BlackRock Liquidity Money Market Fund. We incurred $0.1 million in fees for BlackRock advisory services performed during the three months ended March 31, 2019 . |
Inventory
Inventory | 3 Months Ended |
Mar. 29, 2019 | |
Inventory Disclosure [Abstract] | |
INVENTORY | INVENTORY Inventory consisted of the following (in thousands): March 31, December 31, 2018 Raw materials $ 2,245 $ 1,922 Work in process 6,514 6,170 Finished goods 4,862 3,836 Total $ 13,621 $ 11,928 Balance Sheet classification: Current portion included in Inventory $ 10,143 $ 9,838 Long-term portion included in Other long-term assets 3,478 2,090 Total $ 13,621 $ 11,928 Write-downs related to excess and expiring inventory are charged to Cost of goods sold or the cost of supplied product included in Collaboration revenues . Such write-downs were $0.2 million for the three months ended March 31, 2019 . There were no such write-downs for the three months ended and March 31, 2018 . Inventory not expected to be used in production or sold in the next 12 months is classified as Other long-term assets in the accompanying Condensed Consolidated Balance Sheets. As of both March 31, 2019 and December 31, 2018 , the long-term portion of inventory consisted of portions of our raw materials and finished goods, and as March 31, 2019 , also a portion of our work in process. |
Property and Equipment
Property and Equipment | 3 Months Ended |
Mar. 29, 2019 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY AND EQUIPMENT | PROPERTY AND EQUIPMENT Property and equipment consisted of the following (in thousands): March 31, December 31, Leasehold improvements $ 33,811 $ 33,941 Computer equipment and software 15,110 15,022 Furniture and fixtures 12,908 12,709 Laboratory equipment 6,764 5,668 Construction in progress 1,231 866 69,824 68,206 Less: accumulated depreciation and amortization (19,271 ) (17,309 ) Property and equipment, net $ 50,553 $ 50,897 Depreciation expense was $2.0 million and $0.4 million for the three months ended March 31, 2019 and 2018 , respectively. |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 29, 2019 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
STOCK-BASED COMPENSATION | STOCK-BASED COMPENSATION We allocated the stock-based compensation expense for our equity incentive plans and our 2000 Employee Stock Purchase Plan (ESPP) as follows (in thousands): Three Months Ended March 31, 2019 2018 Research and development $ 4,306 $ 3,033 Selling, general and administrative 8,223 6,272 Total stock-based compensation $ 12,529 $ 9,305 We have several equity incentive plans under which we have granted stock options and restricted stock units (RSUs) to employees and directors. At March 31, 2019 , 14,586,459 shares were available for grant under our equity incentive plans. We used a Monte Carlo simulation pricing model to value stock options that include market vesting conditions and a Black-Scholes Merton option pricing model to value other stock options and ESPP purchases. The weighted average grant-date fair value per share of stock options and ESPP purchases were as follows: Three Months Ended March 31, 2019 2018 Stock options $ 9.21 $ 11.52 ESPP $ 4.67 $ 7.39 The grant-date fair value of stock option grants and ESPP purchases was estimated using the following assumptions: Three Months Ended March 31, 2019 2018 Stock options: Risk-free interest rate 2.22 % 2.40 % Dividend yield — % — % Volatility 49 % 54 % Expected life 4.0 years 4.0 years ESPP: Risk-free interest rate 2.48 % 1.53 % Dividend yield — % — % Volatility 57 % 53 % Expected life 6 months 6 months We considered our implied volatility and our historical volatility in developing our estimates of expected volatility. The assumptions for the expected life of stock options were based on historical exercise patterns and post-vesting termination behavior. The risk-free interest rate is based on U.S. Treasury rates with the same or similar term as the underlying award. Our dividend rate is based on historical experience and our investors’ current expectations. The fair value of RSUs was based on the closing price of the underlying common stock on the date of grant. Activity for stock options during the three months ended March 31, 2019 was as follows (dollars in thousands , except per share amounts): Shares Weighted Average Exercise Price Per Share Weighted Average Remaining Contractual Term Aggregate Intrinsic Value Options outstanding at December 31, 2018 22,674,062 $ 8.71 Granted 246,820 $ 22.94 Exercised (1,413,766 ) $ 4.91 Forfeited (44,200 ) $ 14.32 Expired (22,925 ) $ 22.12 Options outstanding at March 31, 2019 21,439,991 $ 9.10 3.6 years $ 317,143 Exercisable at March 31, 2019 15,714,721 $ 6.01 2.9 years $ 280,307 As of March 31, 2019 , there was $44.1 million of unrecognized compensation expense related to our unvested stock options. The compensation expense for the unvested stock options will be recognized over a weighted-average period of 2.5 years . Activity for RSUs during the three months ended March 31, 2019 was as follows (dollars in thousands , except per share amounts): Shares Weighted Average Grant Date Fair Value Per Share Weighted Average Remaining Contractual Term Aggregate Intrinsic Value RSUs outstanding at December 31, 2018 4,857,334 $ 18.42 Awarded 123,410 $ 22.94 Vested and released (194,296 ) $ 7.83 Forfeited (100,630 ) $ 18.13 RSUs outstanding at March 31, 2019 4,685,818 $ 18.98 2.0 years $ 111,522 During 2018, in connection with our long-term incentive compensation program, we awarded 693,131 RSUs that will vest upon the achievement of certain product revenue, late-stage clinical development and pipeline expansion performance targets (PSUs). The PSUs were designed to drive the performance of our management team toward the achievement of key corporate objectives and will be forfeited if the performance targets are not met by December 31, 2021. Expense recognition for PSUs commences when it is determined that attainment of the performance goal is probable. As of March 31, 2019 , we have not recognized any compensation expense related to these PSUs and the total unrecognized compensation expense was $12.7 million . As of March 31, 2019 , there was $77.0 million of unrecognized compensation expense related to our unvested RSUs, including the PSUs described above. The compensation expense for the unvested RSUs will be recognized over a weighted-average period of 2.9 years . |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 29, 2019 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | INCOME TAXES Our effective income tax rate was 16.4% during the three months ended March 31, 2019 as compared to 2.1% for the three months ended March 31, 2018 . The Provision for income taxes relating to our pre-tax income for the three months ended March 31, 2018 was largely offset by a valuation allowance against our net operating loss carryforwards and other deferred tax assets. At December 31, 2018, we released substantially all of our valuation allowance against our deferred tax assets, after we determined that it was more likely than not that these deferred tax assets would be realized. The effective tax rate for the three months ended March 31, 2019 differed from the U.S. federal statutory rate of 21% primarily was due to excess tax benefits related to the exercise of certain stock options during the quarter. |
Net Income Per Share
Net Income Per Share | 3 Months Ended |
Mar. 29, 2019 | |
Earnings Per Share [Abstract] | |
NET INCOME PER SHARE | NET INCOME PER SHARE The computation of basic and diluted net income per share was as follows (in thousands, except per share amounts): Three Months Ended March 31, 2019 2018 Numerator: Net income $ 75,775 $ 115,857 Denominator: Weighted-average shares of common stock outstanding used in computing basic net income per share 300,542 296,421 Dilutive securities 14,102 17,270 Weighted-average shares of common stock outstanding and dilutive securities used in computing diluted net income per share 314,644 313,691 Net income per share, basic $ 0.25 $ 0.39 Net income per share, diluted $ 0.24 $ 0.37 Dilutive securities include outstanding stock options, unvested RSUs and ESPP contributions. Potential shares of common stock not included in the computation of diluted net income per share because to do so would be anti-dilutive was as follows (in thousands): Three Months Ended March 31, 2019 2018 Potentially dilutive securities 5,089 1,907 |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 29, 2019 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE MEASUREMENTS | FAIR VALUE MEASUREMENTS The classification within the fair value hierarchy of our financial assets that were measured and recorded at fair value on a recurring basis was as follows (in thousands): March 31, 2019 Level 1 Level 2 Total Money market funds $ 75,171 $ — $ 75,171 Commercial paper — 414,317 414,317 Corporate bonds — 418,385 418,385 U.S. Treasury and government sponsored enterprises — 84,487 84,487 Total investments available-for-sale 75,171 917,189 992,360 Certificates of deposit — 25,990 25,990 Total financial assets carried at fair value $ 75,171 $ 943,179 $ 1,018,350 December 31, 2018 Level 1 Level 2 Total Money market funds $ 47,744 $ — $ 47,744 Commercial paper — 381,133 381,133 Corporate bonds — 344,064 344,064 U.S. Treasury and government sponsored enterprises — 55,201 55,201 Total investments available-for-sale 47,744 780,398 828,142 Certificates of deposit — 16,596 16,596 Total financial assets carried at fair value $ 47,744 $ 796,994 $ 844,738 We did not have any financial liabilities measured and recorded at fair value on a recurring basis as of March 31, 2019 or December 31, 2018 . We did not have any financial assets or liabilities classified as Level 3 in the fair value hierarchy as of March 31, 2019 or December 31, 2018 . There were no transfers of financial assets or liabilities between Levels 1, 2 and 3 during the three months ended March 31, 2019 or 2018 . When available, we value investments based on quoted prices for those financial instruments, which is a Level 1 input. Our remaining investments are valued using third-party pricing sources, which use observable market prices, interest rates and yield curves observable at commonly quoted intervals for similar assets as observable inputs for pricing, which is a Level 2 input. See “Note 11. Commitments” to our Consolidated Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2018 for a description of the determination of the amount of our operating lease liabilities. Our remaining financial assets and liabilities include cash and restricted cash, Trade receivables, net, Other receivables, Accounts payable, Accrued compensation and benefits, Accrued clinical trial liabilities, Accrued collaboration liabilities, Rebates and fees due to customers and other current and long-term liabilities. Those financial assets and liabilities are carried at cost which approximates their fair values. |
Subsequent Event
Subsequent Event | 3 Months Ended |
Mar. 29, 2019 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENT | SUBSEQUENT EVENTS Lease Amendment On April 1, 2019, we entered into an amendment to the existing Lease Agreement (the Lease) relating to our corporate headquarters located at 1851, 1801, and 1751 Harbor Bay Parkway, Alameda, California (the Premises). The Lease Amendment provides, among other things, for the (i) expansion of the Premises by 37,544 square feet of office facilities located at 1601 Harbor Bay Parkway, Alameda, California (the 1601 Expansion Space) and (ii) surrender of 2,703 square feet of office facilities located at 1751 Harbor Bay Parkway, Alameda, California (the 1751 Space). We surrendered the 1751 Space on April 15, 2019 and the term for the 1601 Expansion Space will begin ninety days after the landlord’s delivery of the entire 1601 Expansion Space (the 1601 Expansion Space Commencement Date). The term for the 1601 Expansion Space is expected to commence on December 1, 2019, and will run coterminous with the term of the Lease for the existing space, which ends on January 31, 2028. We have been provided an allowance of $1.7 million for tenant improvements to the 1601 Expansion Space. Following April 15, 2019, the monthly base rent for the Premises, other than the 1601 Expansion Space, is $224,505 through January 31, 2020, increasing throughout the remainder of the term to $283,933 at the end of the term. Following the 1601 Expansion Space Commencement Date, the monthly base rent for the 1601 Expansion Space will be $71,334 through November 30, 2020, increasing throughout the remainder of the term to $90,481 at the end of the term. The aggregate contractual base rent for the entire 169,606 square feet of the Premises from April 15, 2019, through the remainder of the Lease term will be approximately $34.6 million . In addition, we are required to pay the landlord for certain operating expenses and taxes they incur related to the Premises. Amendment to Collaboration Agreement with Takeda On April 29, 2019, we executed an amendment to our January 2017 collaboration agreement with Takeda (the Amendment), which will become effective on May 7, 2019. The Amendment, among other things, reduces the amount of reimbursements we will receive from Takeda for costs associated with our required global pharmacovigilance activities and limits those reimbursements to $1.0 million per year. It also increases the total potential development, regulatory and first-sale milestone payments to be paid to us by Takeda for second-line renal cell carcinoma (RCC) , first-line RCC and second-line hepatocellular carcinoma by an aggregate of $12.0 million to $102.0 million , including an increase from $10.0 million to $16.0 million for the milestone we expect to receive for the April 2019 submission of a regulatory application for cabozantinib as a treatment for patients with advanced RCC to the Japanese Ministry of Health, Labour and Welfare. We continue to be eligible to receive additional development, regulatory and first-sale milestone payments for other potential future indications. The Amendment also increases the amount of Takeda’s potential sales-based milestones by an aggregate of $3.0 million to $86.0 million . We continue to be eligible to receive royalties on net sales of cabozantinib in Japan. |
Organization and Summary of S_2
Organization and Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 29, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Consolidation | Basis of Consolidation The accompanying Condensed Consolidated Financial Statements include the accounts of Exelixis and those of our wholly-owned subsidiaries. These entities’ functional currency is the U.S. dollar. All intercompany balances and transactions have been eliminated. |
Basis of Presentation | Basis of Presentation The accompanying unaudited Condensed Consolidated Financial Statements have been prepared in accordance with accounting principles generally accepted in the U.S. for interim financial information and pursuant to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission (SEC). Accordingly, they do not include all of the information and footnotes required by U.S. generally accepted accounting principles for complete financial statements. In our opinion, all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation of our financial statements for the periods presented have been included. |
Fiscal Period | We have adopted a 52- or 53-week fiscal year policy that generally ends on the Friday closest to December 31 st . Fiscal year 2019 will end on January 3, 2020 and fiscal year 2018 ended on December 28, 2018. For convenience, references in this report as of and for the fiscal periods ended March 29, 2019 and March 30, 2018, and as of and for the fiscal years ending January 3, 2020 and ended December 28, 2018, are indicated as being as of and for the periods ended March 31, 2019 and March 31, 2018, and the years ending December 31, 2019 and ended December 31, 2018, respectively. |
Segment Information | Segment Information We operate in one business segment that focuses on the discovery, development and commercialization of new medicines for difficult-to-treat cancers . Our Chief Executive Officer, as the chief operating decision-maker, manages and allocates resources to our operations on a total consolidated basis. Consistent with this decision-making process, our Chief Executive Officer uses consolidated, single-segment financial information for purposes of evaluating performance, forecasting future period financial results, allocating resources and setting incentive targets. All of our long-lived assets are located in the U.S. |
Use of Estimates | Use of Estimates The preparation of the accompanying Condensed Consolidated Financial Statements conforms to accounting principles generally accepted in the U.S., which requires management to make judgments, estimates and assumptions that affect the reported amounts of assets, liabilities, equity, revenues and expenses, and related disclosures. On an ongoing basis, management evaluates its estimates including, but not limited to: those related to revenue recognition, including determining the nature and timing of satisfaction of performance obligations, and determining the standalone selling price of performance obligations, and variable consideration such as rebates, chargebacks, sales returns, sales allowances, and milestone payments included in collaboration arrangements; the amounts of revenues and expenses under our profit and loss sharing agreement; the recoverability of inventory; the amounts of operating lease right-of-use assets and lease liabilities; the amounts of deferred tax assets and liabilities including the related valuation allowance; the accrual for certain liabilities including accrued clinical trial liabilities; and valuations of equity awards used to determine stock-based compensation, including certain awards with vesting subject to market or performance conditions. We base our estimates on historical experience and on various other market-specific and other relevant assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ materially from those estimates. |
Reclassifications | Reclassifications Certain prior period amounts in the accompanying Condensed Consolidated Financial Statements have been reclassified to conform to current period presentation. |
Recently Adopted Accounting Pronouncements and Recent Accounting Pronouncements Not Yet Adopted | Recently Adopted Accounting Pronouncements On January 1, 2019, we adopted ASU 2018-02, Income Statement—Reporting Comprehensive Income (Topic 220) (ASU 2018-02). There was no financial impact from the adoption of ASU 2018-02 and we did not make an election to reclassify the income tax effects of the Tax Cuts and Jobs Act of 2017 from Accumulated other comprehensive income (loss) to Accumulated deficit. In connection with the adoption of ASU 2018-02, we have adopted the individual unit of account approach for releasing income tax effects from Accumulated other comprehensive income (loss) . On January 1, 2019, we also adopted ASU 2017-08 , Receivables—Nonrefundable Fees and Other Costs (Subtopic 310-20) (ASU 2017-08). ASU 2017-08 shortens the amortization period for certain callable debt securities held at a premium. Specifically, ASU 2017-08 requires the premium to be amortized to the earliest call date. ASU 2017-08 does not require an accounting change for securities held at a discount; the discount continues to be amortized to maturity. The financial impact from the adoption of ASU 2017-08 was nominal. Recent Accounting Pronouncements Not Yet Adopted In November 2018, the Financial Accounting Standards Board (the FASB) issued ASU No. 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 (ASU 2018-18). ASU 2018-18 clarifies that certain transactions between collaborative arrangement participants should be accounted for as revenue under Topic 606 when the counterparty is a customer for a distinct good or service (i.e. a unit of account). For units of account that are in the scope of Topic 606, all of the guidance in Topic 606 should be applied, including the guidance on recognition, measurement, presentation and disclosure. ASU 2018-18 also adds a reference in Topic 808 to the unit of account guidance in ASC 606 and requires that it be applied only to assess whether transactions in a collaborative arrangement are in the scope of Topic 606. ASU 2018-18 will preclude entities from presenting amounts related to transactions with a counterparty in a collaborative arrangement that is not a customer as revenue from contracts with customers. ASU 2018-18 is effective for us for all interim and annual reporting periods beginning after December 15, 2019. Early adoption is permitted. We are in the process of assessing the impact of ASU 2018-18 on our Condensed Consolidated Financial Statements. In August 2018, the FASB issued ASU No. 2018-15, Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40): Customer's Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract (ASU 2018-15). ASU 2018-15 aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software (and hosting arrangements that include an internal-use software license). Accordingly, ASU 2018-15 requires a customer in a hosting arrangement that is a service contract to follow the guidance in Subtopic 350-40 to determine which implementation costs to capitalize as an asset related to the service contract and which costs to expense. ASU 2018-15 also requires us to expense the capitalized implementation costs of a hosting arrangement that is a service contract over the term of the hosting arrangement, which includes reasonably certain renewals. ASU 2018-15 is effective for us for all interim and annual reporting periods beginning after December 15, 2019. Early adoption is permitted. We are in the process of assessing the impact of ASU 2018-15 on our Condensed Consolidated Financial Statements. In January 2017, the FASB issued ASU No. 2017-04, Intangibles—Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment (ASU 2017-04) . ASU 2017-04 eliminated Step 2 from the goodwill impairment test. Instead, under the amendments in ASU 2017-04, an entity should perform its annual, or interim, goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount. An entity should recognize an impairment charge for the amount by which the carrying amount exceeds the reporting unit’s fair value; however, the loss recognized should not exceed the total amount of goodwill allocated to that reporting unit. Additionally, an entity should consider income tax effects from any tax deductible goodwill on the carrying amount of the reporting unit when measuring the goodwill impairment loss, if applicable. ASU 2017-04 is effective for all interim and annual reporting periods beginning after December 15, 2019. Early adoption is permitted. We do not expect the adoption of ASU 2017-04 to have a material impact on our Condensed Consolidated Financial Statements. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326) (ASU 2016-13) . ASU 2016-13 implements an impairment model, known as the current expected credit loss model, that is based on expected losses rather than incurred losses. Under the new guidance, an entity will recognize as an allowance its estimate of expected credit losses. 2016-13 is effective for all interim and annual reporting periods beginning after December 15, 2019. Early adoption is permitted. We do not expect the adoption of ASU 2016-13 to have a material impact on our Condensed Consolidated Financial Statements. |
Revenue | Chargebacks and discounts for prompt payment are recorded as a reduction of trade receivables and the remaining reserve balances are classified as Other current liabilities in the accompanying Condensed Consolidated Balance Sheets. Contract Assets and Liabilities We receive payments from our licensees based on billing schedules established in each contract. Amounts are recorded as accounts receivable when our right to consideration is unconditional. Upfront and milestone payments may require deferral of revenue recognition to a future period until we perform our obligations under these arrangements and are recorded as deferred revenue upon receipt or when due. We may also recognize revenue in advance of the contractual billing schedule and such amounts are recorded as unbilled collaboration revenue when recognized. Net product revenues, License revenues and Research and development services revenues were recorded in accordance with Topic 606 for all periods presented. Net product revenues and License revenues related to goods and intellectual property licenses transferred at a point in time and Research and development services revenues related to services performed over time. Other collaboration revenues, which included the p rofit on the U.S. commercialization of COTELLIC and net losses on product supply services, were recorded in accordance with ASC Topic 808, Collaborative Arrangements for all periods presented . Net product revenues are attributed to geographic region based on the ship-to location. Collaboration revenues are attributed to geographic region based on the location of our collaboration partners’ headquarters. |
Revenues (Tables)
Revenues (Tables) | 3 Months Ended |
Mar. 29, 2019 | |
Revenue from Contract with Customer [Abstract] | |
Disaggregation of Revenue | Revenues by disaggregated category were as follows (in thousands): Three Months Ended March 31, 2019 2018 Product revenues: Gross product revenues $ 223,750 $ 159,436 Discounts and allowances (44,169 ) (25,164 ) Net product revenues 179,581 134,272 Collaboration revenues: License revenues (1) 24,509 69,030 Research and development service revenues (2) 11,928 10,099 Other collaboration revenues (3) (531 ) 318 Total collaboration revenues 35,906 79,447 Total revenues $ 215,487 $ 213,719 ____________________ (1) License revenues included the immediate recognition of the portion of milestones allocated to the transfer of intellectual property licenses for which it had become probable in the current period that the milestone would be achieved and a significant revenue reversal would not occur, as well as royalty revenues from Ipsen Pharma SAS (Ipsen) and Genentech. (2) Research and development service revenues included the recognition of deferred revenue for the portion of upfront and milestone payments that have been allocated to research and development service performance obligations, as well as development cost reimbursements earned on our collaboration agreements. (3) Other collaboration revenues included the profit on the U.S. commercialization of COTELLIC from Genentech and revenues on product supply services provided to Ipsen and Takeda Pharmaceutical Company Ltd. (Takeda), which were partially offset by the 3% royalty we are required to pay GlaxoSmithKline (GSK) on the net sales by Ipsen of any product incorporating cabozantinib. Net product revenues, License revenues and Research and development services revenues were recorded in accordance with Topic 606 for all periods presented. Net product revenues and License revenues related to goods and intellectual property licenses transferred at a point in time and Research and development services revenues related to services performed over time. Other collaboration revenues, which included the p rofit on the U.S. commercialization of COTELLIC and net losses on product supply services, were recorded in accordance with ASC Topic 808, Collaborative Arrangements for all periods presented . Net product revenues disaggregated by product were as follows (in thousands): Three Months Ended March 31, 2019 2018 CABOMETYX $ 175,890 $ 128,934 COMETRIQ 3,691 5,338 Net product revenues $ 179,581 $ 134,272 Total revenues disaggregated by significant customer were as follows (dollars in thousands): Three Months Ended March 31, 2019 2018 Dollars Percent of total Dollars Percent of total Caremark L.L.C. $ 32,698 15 % $ 26,388 12 % Affiliates of McKesson Corporation 25,311 12 % 21,331 10 % Accredo Health, Incorporated 22,495 10 % 18,286 9 % Affiliates of AmerisourceBergen Corporation 21,902 10 % 15,736 7 % Ipsen 21,868 10 % 53,809 25 % Others, individually less than 10% of Total revenues for all periods presented 91,213 43 % 78,169 37 % Total revenues $ 215,487 100 % $ 213,719 100 % Total revenues disaggregated by geographic region were as follows (in thousands): Three Months Ended March 31, 2019 2018 U.S. $ 182,126 $ 136,993 Europe 21,868 53,809 Rest of the world 11,493 22,917 Total revenues $ 215,487 $ 213,719 |
Activities and Ending Reserve Balances for Significant Categories of Discounts and Allowances | The activities and ending reserve balances for each significant category of discounts and allowances (which constitute variable consideration) were as follows (in thousands): Chargebacks and Discounts for Prompt Payment Other Customer Credits/Fees and Co-pay Assistance Rebates Returns Total Balance at December 31, 2018 $ 2,322 $ 3,038 $ 11,916 $ — $ 17,276 Provision related to sales made in: Current period 27,153 3,875 12,905 — 43,933 Prior periods — 9 227 — 236 Payments and customer credits issued (27,367 ) (4,189 ) (8,073 ) — (39,629 ) Balance at March 31, 2019 $ 2,108 $ 2,733 $ 16,975 $ — $ 21,816 |
Contract Assets and Liabilities under Topic 606 | Changes in our contract assets and liabilities under Topic 606 were as follows (in thousands): Contract Assets: Unbilled Collaboration Revenue Contract Liabilities: Deferred Revenue Current Portion Long-term Portion Current Portion Long-term Portion Balance at December 31, 2018 $ — $ — $ — $ 15,897 Increases as a result of a change in transaction price and recognition of revenues as services are performed 10,222 1,450 — — Transfer to receivables from contract assets recognized at the beginning of the period (543 ) — — — Increases as a result of the deferral of milestones achieved in period, excluding amounts recognized as revenue — — — — Revenue recognized that was included in the contract liability balance at the beginning of the period — — (1,313 ) — Other adjustments (1) (2,435 ) (1,450 ) 3,689 (7,574 ) Balance at March 31, 2019 $ 7,244 $ — $ 2,376 $ 8,323 ____________________ (1) Includes reclassification of deferred revenue from long-term to current and adjustments made due to netting of contract assets and liabilities by collaboration agreement. |
Collaboration Agreements (Table
Collaboration Agreements (Tables) | 3 Months Ended |
Mar. 29, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Collaborative Revenues Under Collaboration Agreement | Profits on U.S. commercialization and Royalty revenues on ex-U.S. sales were as follows (in thousands): Three Months Ended March 31, 2019 2018 Profits on U.S. commercialization $ 1,055 $ 1,373 Royalty revenues on ex-U.S. sales $ 1,490 $ 1,349 Collaboration revenues under the collaboration agreement with Ipsen were as follows (in thousands): Three Months Ended March 31, 2019 2018 Ipsen collaboration revenues $ 21,868 $ 53,809 Collaboration revenues under the collaboration agreement with Takeda were as follows (in thousands): Three Months Ended March 31, 2019 2018 Takeda collaboration revenues $ 11,493 $ 2,917 |
Cash and Investments (Tables)
Cash and Investments (Tables) | 3 Months Ended |
Mar. 29, 2019 | |
Investments, Debt and Equity Securities [Abstract] | |
Reconciliation of Cash, Cash Equivalents, and Restricted Cash | A reconciliation of Cash, cash equivalents, and restricted cash reported within our Condensed Consolidated Balance Sheets to the amount reported within the accompanying Condensed Consolidated Statements of Cash Flows was as follows (in thousands): March 31, 2019 December 31, 2018 March 31, 2018 December 31, 2017 Cash and cash equivalents $ 373,937 $ 314,775 $ 232,331 $ 183,164 Restricted cash included in short-term restricted cash and investments — — 504 504 Restricted cash included in long-term restricted cash and investments 1,100 1,100 1,500 4,646 Cash, cash equivalents, and restricted cash as reported within the accompanying Condensed Consolidated Statements of Cash Flows $ 375,037 $ 315,875 $ 234,335 $ 188,314 |
Reconciliation of Cash, Cash Equivalents, and Restricted Cash | A reconciliation of Cash, cash equivalents, and restricted cash reported within our Condensed Consolidated Balance Sheets to the amount reported within the accompanying Condensed Consolidated Statements of Cash Flows was as follows (in thousands): March 31, 2019 December 31, 2018 March 31, 2018 December 31, 2017 Cash and cash equivalents $ 373,937 $ 314,775 $ 232,331 $ 183,164 Restricted cash included in short-term restricted cash and investments — — 504 504 Restricted cash included in long-term restricted cash and investments 1,100 1,100 1,500 4,646 Cash, cash equivalents, and restricted cash as reported within the accompanying Condensed Consolidated Statements of Cash Flows $ 375,037 $ 315,875 $ 234,335 $ 188,314 |
Investments by Security Type | Cash and investments by security type were as follows (in thousands): March 31, 2019 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Investments available-for-sale: Money market funds $ 75,171 $ — $ — $ 75,171 Commercial paper 414,317 — — 414,317 Corporate bonds 417,303 1,257 (175 ) 418,385 U.S. Treasury and government sponsored enterprises 84,448 41 (2 ) 84,487 Total investments available-for-sale 991,239 1,298 (177 ) 992,360 Cash and restricted cash 1,019 — — 1,019 Certificates of deposit 25,990 — — 25,990 Total cash and investments $ 1,018,248 $ 1,298 $ (177 ) $ 1,019,369 December 31, 2018 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Investments available-for-sale: Money market funds $ 47,744 $ — $ — $ 47,744 Commercial paper 381,134 — (1 ) 381,133 Corporate bonds 344,741 180 (857 ) 344,064 U.S. Treasury and government sponsored enterprises 55,224 2 (25 ) 55,201 Total investments available-for-sale 828,843 182 (883 ) 828,142 Cash and restricted cash 6,883 — — 6,883 Certificates of deposit 16,596 — — 16,596 Total cash and investments $ 852,322 $ 182 $ (883 ) $ 851,621 |
Fair Value and Gross Unrealized Losses of Investments Available-for-Sale in an Unrealized Loss Position | The fair value and gross unrealized losses on investments available-for-sale in an unrealized loss position were as follows (in thousands): March 31, 2019 In an Unrealized Loss Position Less than 12 Months In an Unrealized Loss Position 12 Months or Greater Total Fair Value Gross Fair Value Gross Fair Value Gross Corporate bonds $ 49,233 $ (39 ) $ 45,010 $ (136 ) $ 94,243 $ (175 ) U.S. Treasury and government sponsored enterprises — — 7,990 (2 ) 7,990 (2 ) Total $ 49,233 $ (39 ) $ 53,000 $ (138 ) $ 102,233 $ (177 ) December 31, 2018 In an Unrealized Loss Position Less than 12 Months In an Unrealized Loss Position 12 Months or Greater Total Fair Value Gross Fair Value Gross Fair Value Gross Corporate bonds $ 236,162 $ (606 ) $ 39,627 $ (251 ) $ 275,789 $ (857 ) U.S. Treasury and government sponsored enterprises 28,105 (16 ) 9,182 (9 ) 37,287 (25 ) Commercial paper 7,091 (1 ) — — 7,091 (1 ) Total $ 271,358 $ (623 ) $ 48,809 $ (260 ) $ 320,167 $ (883 ) |
Fair Value of Cash Equivalents and Investments by Contractual Maturity | The fair value of investments available-for-sale by contractual maturity were as follows (in thousands): March 31, December 31, 2018 Maturing in one year or less $ 784,432 $ 674,455 Maturing after one year through five years 207,928 153,687 Total investments available-for-sale $ 992,360 $ 828,142 |
Inventory (Tables)
Inventory (Tables) | 3 Months Ended |
Mar. 29, 2019 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventory consisted of the following (in thousands): March 31, December 31, 2018 Raw materials $ 2,245 $ 1,922 Work in process 6,514 6,170 Finished goods 4,862 3,836 Total $ 13,621 $ 11,928 Balance Sheet classification: Current portion included in Inventory $ 10,143 $ 9,838 Long-term portion included in Other long-term assets 3,478 2,090 Total $ 13,621 $ 11,928 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 3 Months Ended |
Mar. 29, 2019 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and equipment consisted of the following (in thousands): March 31, December 31, Leasehold improvements $ 33,811 $ 33,941 Computer equipment and software 15,110 15,022 Furniture and fixtures 12,908 12,709 Laboratory equipment 6,764 5,668 Construction in progress 1,231 866 69,824 68,206 Less: accumulated depreciation and amortization (19,271 ) (17,309 ) Property and equipment, net $ 50,553 $ 50,897 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 29, 2019 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Allocated Employee Stock-Based Compensation Expense | We allocated the stock-based compensation expense for our equity incentive plans and our 2000 Employee Stock Purchase Plan (ESPP) as follows (in thousands): Three Months Ended March 31, 2019 2018 Research and development $ 4,306 $ 3,033 Selling, general and administrative 8,223 6,272 Total stock-based compensation $ 12,529 $ 9,305 |
Weighted Average Grant-Date Fair Value of Stock Options and ESPP Purchases | The weighted average grant-date fair value per share of stock options and ESPP purchases were as follows: Three Months Ended March 31, 2019 2018 Stock options $ 9.21 $ 11.52 ESPP $ 4.67 $ 7.39 |
Valuation Assumptions Used to Estimate Grant-Date Fair Value | The grant-date fair value of stock option grants and ESPP purchases was estimated using the following assumptions: Three Months Ended March 31, 2019 2018 Stock options: Risk-free interest rate 2.22 % 2.40 % Dividend yield — % — % Volatility 49 % 54 % Expected life 4.0 years 4.0 years ESPP: Risk-free interest rate 2.48 % 1.53 % Dividend yield — % — % Volatility 57 % 53 % Expected life 6 months 6 months |
Stock Option Activity | Activity for stock options during the three months ended March 31, 2019 was as follows (dollars in thousands , except per share amounts): Shares Weighted Average Exercise Price Per Share Weighted Average Remaining Contractual Term Aggregate Intrinsic Value Options outstanding at December 31, 2018 22,674,062 $ 8.71 Granted 246,820 $ 22.94 Exercised (1,413,766 ) $ 4.91 Forfeited (44,200 ) $ 14.32 Expired (22,925 ) $ 22.12 Options outstanding at March 31, 2019 21,439,991 $ 9.10 3.6 years $ 317,143 Exercisable at March 31, 2019 15,714,721 $ 6.01 2.9 years $ 280,307 |
RSU Activity | Activity for RSUs during the three months ended March 31, 2019 was as follows (dollars in thousands , except per share amounts): Shares Weighted Average Grant Date Fair Value Per Share Weighted Average Remaining Contractual Term Aggregate Intrinsic Value RSUs outstanding at December 31, 2018 4,857,334 $ 18.42 Awarded 123,410 $ 22.94 Vested and released (194,296 ) $ 7.83 Forfeited (100,630 ) $ 18.13 RSUs outstanding at March 31, 2019 4,685,818 $ 18.98 2.0 years $ 111,522 |
Net Income Per Share (Tables)
Net Income Per Share (Tables) | 3 Months Ended |
Mar. 29, 2019 | |
Earnings Per Share [Abstract] | |
Computation of Basic and Diluted Net Income Per Share | The computation of basic and diluted net income per share was as follows (in thousands, except per share amounts): Three Months Ended March 31, 2019 2018 Numerator: Net income $ 75,775 $ 115,857 Denominator: Weighted-average shares of common stock outstanding used in computing basic net income per share 300,542 296,421 Dilutive securities 14,102 17,270 Weighted-average shares of common stock outstanding and dilutive securities used in computing diluted net income per share 314,644 313,691 Net income per share, basic $ 0.25 $ 0.39 Net income per share, diluted $ 0.24 $ 0.37 |
Potential Shares of Common Stock Not Included in the Computation of Diluted Net Income (Loss) Per Share | Potential shares of common stock not included in the computation of diluted net income per share because to do so would be anti-dilutive was as follows (in thousands): Three Months Ended March 31, 2019 2018 Potentially dilutive securities 5,089 1,907 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 29, 2019 | |
Fair Value Disclosures [Abstract] | |
Classification of Financial Assets Measured and Recorded at Fair Value on a Recurring Basis | The classification within the fair value hierarchy of our financial assets that were measured and recorded at fair value on a recurring basis was as follows (in thousands): March 31, 2019 Level 1 Level 2 Total Money market funds $ 75,171 $ — $ 75,171 Commercial paper — 414,317 414,317 Corporate bonds — 418,385 418,385 U.S. Treasury and government sponsored enterprises — 84,487 84,487 Total investments available-for-sale 75,171 917,189 992,360 Certificates of deposit — 25,990 25,990 Total financial assets carried at fair value $ 75,171 $ 943,179 $ 1,018,350 December 31, 2018 Level 1 Level 2 Total Money market funds $ 47,744 $ — $ 47,744 Commercial paper — 381,133 381,133 Corporate bonds — 344,064 344,064 U.S. Treasury and government sponsored enterprises — 55,201 55,201 Total investments available-for-sale 47,744 780,398 828,142 Certificates of deposit — 16,596 16,596 Total financial assets carried at fair value $ 47,744 $ 796,994 $ 844,738 |
Organization and Summary of S_3
Organization and Summary of Significant Accounting Policies (Details) $ in Thousands | 3 Months Ended | |
Mar. 29, 2019USD ($)segmentproduct | Mar. 30, 2018USD ($) | |
Organization And Summary Of Significant Policies [Line Items] | ||
Number of products that entered in the commercial marketplace | 4 | |
Number of business segments | segment | 1 | |
Selling, general and administrative | $ | $ 60,138 | $ 54,016 |
Restatement Adjustment | ||
Organization And Summary Of Significant Policies [Line Items] | ||
Selling, general and administrative | $ | $ (1,400) | |
Commercial Presence in Markets Worldwide | ||
Organization And Summary Of Significant Policies [Line Items] | ||
Number of products that entered in the commercial marketplace | 3 | |
Products Derived from Cabozantinib | ||
Organization And Summary Of Significant Policies [Line Items] | ||
Number of products that entered in the commercial marketplace | 2 |
Revenues - Revenues by Disaggre
Revenues - Revenues by Disaggregated Category (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 29, 2019 | Mar. 30, 2018 | |
Disaggregation of Revenue [Line Items] | ||
Total revenues | $ 215,487 | $ 213,719 |
Collaborative Arrangement with Ipsen | ||
Disaggregation of Revenue [Line Items] | ||
Total revenues | $ 21,868 | 53,809 |
GSK | Collaborative Arrangement with Ipsen | ||
Disaggregation of Revenue [Line Items] | ||
Percent of royalty on net sale | 3.00% | |
Net product revenues | ||
Disaggregation of Revenue [Line Items] | ||
Total revenues | $ 179,581 | 134,272 |
Gross product revenues | ||
Disaggregation of Revenue [Line Items] | ||
Total revenues | 223,750 | 159,436 |
Discounts and allowances | ||
Disaggregation of Revenue [Line Items] | ||
Total revenues | 44,169 | 25,164 |
Total collaboration revenues | ||
Disaggregation of Revenue [Line Items] | ||
Total revenues | 35,906 | 79,447 |
License revenues | ||
Disaggregation of Revenue [Line Items] | ||
Total revenues | 24,509 | 69,030 |
Research and development services revenues | ||
Disaggregation of Revenue [Line Items] | ||
Total revenues | 11,928 | 10,099 |
Other collaboration revenues | ||
Disaggregation of Revenue [Line Items] | ||
Total revenues | $ (531) | $ 318 |
Revenues - Net Product Revenues
Revenues - Net Product Revenues Disaggregated by Product (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 29, 2019 | Mar. 30, 2018 | |
Disaggregation of Revenue [Line Items] | ||
Net product revenues | $ 215,487 | $ 213,719 |
Net product revenues | ||
Disaggregation of Revenue [Line Items] | ||
Net product revenues | 179,581 | 134,272 |
CABOMETYX | ||
Disaggregation of Revenue [Line Items] | ||
Net product revenues | 175,890 | 128,934 |
COMETRIQ | ||
Disaggregation of Revenue [Line Items] | ||
Net product revenues | $ 3,691 | $ 5,338 |
Revenues - Revenues Disaggregat
Revenues - Revenues Disaggregated by Significant Customer (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 29, 2019 | Mar. 30, 2018 | |
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||
Total revenues | $ 215,487 | $ 213,719 |
Revenue | Customer Concentration Risk | ||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||
Percent of total revenues | 100.00% | 100.00% |
Caremark L.L.C. | ||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||
Total revenues | $ 32,698 | $ 26,388 |
Caremark L.L.C. | Revenue | Customer Concentration Risk | ||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||
Percent of total revenues | 15.00% | 12.00% |
Affiliates of McKesson Corporation | ||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||
Total revenues | $ 25,311 | $ 21,331 |
Affiliates of McKesson Corporation | Revenue | Customer Concentration Risk | ||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||
Percent of total revenues | 12.00% | 10.00% |
Accredo Health, Incorporated | ||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||
Total revenues | $ 22,495 | $ 18,286 |
Accredo Health, Incorporated | Revenue | Customer Concentration Risk | ||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||
Percent of total revenues | 10.00% | 9.00% |
Affiliates of AmerisourceBergen Corporation | ||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||
Total revenues | $ 21,902 | $ 15,736 |
Affiliates of AmerisourceBergen Corporation | Revenue | Customer Concentration Risk | ||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||
Percent of total revenues | 10.00% | 7.00% |
Ipsen | ||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||
Total revenues | $ 21,868 | $ 53,809 |
Ipsen | Revenue | Customer Concentration Risk | ||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||
Percent of total revenues | 10.00% | 25.00% |
Others, individually less than 10% of Total revenues for all periods presented | ||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||
Total revenues | $ 91,213 | $ 78,169 |
Others, individually less than 10% of Total revenues for all periods presented | Revenue | Customer Concentration Risk | ||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||
Percent of total revenues | 43.00% | 37.00% |
Revenues - Revenues Disaggreg_2
Revenues - Revenues Disaggregated by Geographic Region (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 29, 2019 | Mar. 30, 2018 | |
Disaggregation of Revenue [Line Items] | ||
Total revenues | $ 215,487 | $ 213,719 |
U.S. | ||
Disaggregation of Revenue [Line Items] | ||
Total revenues | 182,126 | 136,993 |
Europe | ||
Disaggregation of Revenue [Line Items] | ||
Total revenues | 21,868 | 53,809 |
Rest of the world | ||
Disaggregation of Revenue [Line Items] | ||
Total revenues | $ 11,493 | $ 22,917 |
Revenues - Activities and Endin
Revenues - Activities and Ending Reserve Balances for Significant Categories of Discounts and Allowances (Details) $ in Thousands | 3 Months Ended |
Mar. 29, 2019USD ($) | |
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |
Balance at December 31, 2018 | $ 17,276 |
Provision related to sales made in: | |
Current period | 43,933 |
Prior periods | 236 |
Payments and customer credits issued | (39,629) |
Balance at March 31, 2019 | 21,816 |
Chargebacks and Discounts for Prompt Payment | |
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |
Balance at December 31, 2018 | 2,322 |
Provision related to sales made in: | |
Current period | 27,153 |
Prior periods | 0 |
Payments and customer credits issued | (27,367) |
Balance at March 31, 2019 | 2,108 |
Other Customer Credits/Fees and Co-pay Assistance | |
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |
Balance at December 31, 2018 | 3,038 |
Provision related to sales made in: | |
Current period | 3,875 |
Prior periods | 9 |
Payments and customer credits issued | (4,189) |
Balance at March 31, 2019 | 2,733 |
Rebates | |
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |
Balance at December 31, 2018 | 11,916 |
Provision related to sales made in: | |
Current period | 12,905 |
Prior periods | 227 |
Payments and customer credits issued | (8,073) |
Balance at March 31, 2019 | 16,975 |
Returns | |
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |
Balance at December 31, 2018 | 0 |
Provision related to sales made in: | |
Current period | 0 |
Prior periods | 0 |
Payments and customer credits issued | 0 |
Balance at March 31, 2019 | $ 0 |
Revenues - Changes in Contract
Revenues - Changes in Contract Assets and Liabilities under Topic 606 (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 29, 2019 | Mar. 30, 2018 | ||
Contract Assets - Current Portion | |||
Balance | [1] | $ 0 | |
Increases as a result of a change in transaction price and recognition of revenues as services are performed | 10,222 | ||
Transfer to receivables from contract assets recognized at the beginning of the period | (543) | ||
Other | (2,435) | ||
Balance | 7,244 | ||
Contract Assets - Long-term Portion | |||
Increases as a result of a change in transaction price and recognition of revenues as services are performed | 1,450 | ||
Other | (1,450) | ||
Balance | 0 | ||
Contract Liabilities - Current Portion | |||
Balance | [1] | 0 | |
Increases as a result of the deferral of milestones achieved in period, excluding amounts recognized as revenue | 0 | ||
Revenue recognized that was included in the contract liability balance at the beginning of the period | (1,313) | ||
Other | 3,689 | ||
Balance | 2,376 | ||
Contract Liabilities - Long-term Portion | |||
Balance | [1] | 15,897 | |
Increases as a result of the deferral of milestones achieved in period, excluding amounts recognized as revenue | 0 | ||
Other | (7,574) | ||
Balance | 8,323 | ||
Revenues recognized for performance obligations satisfied in previous periods | 25,300 | $ 71,300 | |
Balances Without the Adoption of Topic 606 | |||
Contract Assets - Current Portion | |||
Balance | 0 | ||
Contract Assets - Long-term Portion | |||
Balance | 0 | ||
Contract Liabilities - Current Portion | |||
Balance | 0 | ||
Contract Liabilities - Long-term Portion | |||
Balance | $ 15,897 | ||
[1] | The Condensed Consolidated Balance Sheet as of December 31, 2018 has been derived from the audited financial statements as of that date. |
Collaboration Agreements - Coll
Collaboration Agreements - Collaboration Revenues under the Collaboration Agreement with Ipsen (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 29, 2019 | Mar. 30, 2018 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Total revenues | $ 215,487 | $ 213,719 |
Collaborative Arrangement with Ipsen | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Total revenues | $ 21,868 | $ 53,809 |
Collaboration Agreements - Ipse
Collaboration Agreements - Ipsen Collaboration (Details) - USD ($) $ in Thousands | Mar. 29, 2019 | Dec. 28, 2018 | [1] |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Net contract liability, current portion of deferred revenue | $ 2,376 | $ 0 | |
Net contract liability, long-term portion of deferred revenue | 8,323 | $ 15,897 | |
Collaborative Arrangement with Ipsen | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Remaining performance obligation | 46,800 | ||
Net contract liability | 10,700 | ||
Net contract liability, current portion of deferred revenue | 2,400 | ||
Net contract liability, long-term portion of deferred revenue | $ 8,300 | ||
[1] | The Condensed Consolidated Balance Sheet as of December 31, 2018 has been derived from the audited financial statements as of that date. |
Collaboration Agreements - Co_2
Collaboration Agreements - Collaboration Revenues under the Collaboration Agreement with Takeda (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 29, 2019 | Mar. 30, 2018 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Total revenues | $ 215,487 | $ 213,719 |
Collaborative Arrangement with Takeda | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Total revenues | $ 11,493 | $ 2,917 |
Collaboration Agreements - Take
Collaboration Agreements - Takeda Collaboration (Details) - Collaborative Arrangement with Takeda $ in Millions | Mar. 29, 2019USD ($) |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Remaining performance obligation | $ 25.2 |
Net contract liability | $ 7.2 |
Collaboration Agreements - Roya
Collaboration Agreements - Royalty Revenues under the Collaboration Agreement with GSK (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 29, 2019 | Mar. 30, 2018 | |
Collaboration Agreement with GlaxoSmithKline | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Royalties accruing to GSK | $ 7,282 | $ 5,125 |
GSK | Collaborative Arrangement with Ipsen | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Percent of royalty on net sale | 3.00% |
Collaboration Agreements - Ro_2
Collaboration Agreements - Royalty Revenues under the Collaboration Agreement with Genentech (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 29, 2019 | Mar. 30, 2018 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Royalty revenues on ex-U.S. sales | $ 215,487 | $ 213,719 |
COTELLIC | Collaborative Arrangement with Genentech | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Royalty revenues on ex-U.S. sales | 1,490 | 1,349 |
Profits and losses on U.S. commercialization | $ 1,055 | $ 1,373 |
Cash and Investments - Reconcil
Cash and Investments - Reconciliation of Cash, Cash Equivalents, and Restricted Cash (Details) - USD ($) $ in Thousands | Mar. 29, 2019 | Dec. 28, 2018 | Mar. 30, 2018 | Dec. 29, 2017 | |
Cash and Cash Equivalents [Abstract] | |||||
Cash and cash equivalents | $ 373,937 | $ 314,775 | [1] | $ 232,331 | $ 183,164 |
Restricted cash included in short-term restricted cash and investments | 0 | 0 | [1] | 504 | 504 |
Restricted cash included in long-term restricted cash and investments | 1,100 | 1,100 | [1] | 1,500 | 4,646 |
Cash, cash equivalents, and restricted cash as reported within the accompanying Condensed Consolidated Statements of Cash Flows | $ 375,037 | $ 315,875 | $ 234,335 | $ 188,314 | |
[1] | The Condensed Consolidated Balance Sheet as of December 31, 2018 has been derived from the audited financial statements as of that date. |
Cash and Investments - Investme
Cash and Investments - Investments by Security Type (Details) - USD ($) $ in Thousands | Mar. 29, 2019 | Dec. 28, 2018 | Mar. 30, 2018 | Dec. 29, 2017 |
Investment [Line Items] | ||||
Amortized Cost | $ 991,239 | $ 828,843 | ||
Amortized Cost | 375,037 | 315,875 | $ 234,335 | $ 188,314 |
Gross Unrealized Gains | 1,298 | 182 | ||
Gross Unrealized Losses | (177) | (883) | ||
Fair Value | 992,360 | 828,142 | ||
Total cash and investments, amortized cost | 1,018,248 | 852,322 | ||
Total cash and investments, fair value | 1,019,369 | 851,621 | ||
Money market funds | ||||
Investment [Line Items] | ||||
Amortized Cost | 75,171 | 47,744 | ||
Gross Unrealized Gains | 0 | 0 | ||
Gross Unrealized Losses | 0 | 0 | ||
Fair Value | 75,171 | 47,744 | ||
Commercial paper | ||||
Investment [Line Items] | ||||
Amortized Cost | 414,317 | 381,134 | ||
Gross Unrealized Gains | 0 | 0 | ||
Gross Unrealized Losses | 0 | (1) | ||
Fair Value | 414,317 | 381,133 | ||
Corporate bonds | ||||
Investment [Line Items] | ||||
Amortized Cost | 417,303 | 344,741 | ||
Gross Unrealized Gains | 1,257 | 180 | ||
Gross Unrealized Losses | (175) | (857) | ||
Fair Value | 418,385 | 344,064 | ||
U.S. Treasury and government sponsored enterprises | ||||
Investment [Line Items] | ||||
Amortized Cost | 84,448 | 55,224 | ||
Gross Unrealized Gains | 41 | 2 | ||
Gross Unrealized Losses | (2) | (25) | ||
Fair Value | 84,487 | 55,201 | ||
Cash and restricted cash | ||||
Investment [Line Items] | ||||
Amortized Cost | 1,019 | 6,883 | ||
Fair Value | 1,019 | 6,883 | ||
Certificates of deposit | ||||
Investment [Line Items] | ||||
Amortized Cost | 25,990 | 16,596 | ||
Fair Value | $ 25,990 | $ 16,596 |
Cash and Investments - Fair Val
Cash and Investments - Fair Value and Gross Unrealized Losses of Investments Available-for-Sale in an Unrealized Loss Position (Details) - USD ($) $ in Thousands | Mar. 29, 2019 | Dec. 28, 2018 |
Fair Value | ||
In an Unrealized Loss Position Less than 12 Months | $ 49,233 | $ 271,358 |
In an Unrealized Loss Position 12 Months or Greater | 53,000 | 48,809 |
Total | 102,233 | 320,167 |
Gross Unrealized Losses | ||
In an Unrealized Loss Position Less than 12 Months | (39) | (623) |
In an Unrealized Loss Position 12 Months or Greater | (138) | (260) |
Total | (177) | (883) |
U.S. Treasury and government sponsored enterprises | ||
Fair Value | ||
In an Unrealized Loss Position Less than 12 Months | 0 | 28,105 |
In an Unrealized Loss Position 12 Months or Greater | 7,990 | 9,182 |
Total | 7,990 | 37,287 |
Gross Unrealized Losses | ||
In an Unrealized Loss Position Less than 12 Months | 0 | (16) |
In an Unrealized Loss Position 12 Months or Greater | (2) | (9) |
Total | (2) | (25) |
Corporate bonds | ||
Fair Value | ||
In an Unrealized Loss Position Less than 12 Months | 49,233 | 236,162 |
In an Unrealized Loss Position 12 Months or Greater | 45,010 | 39,627 |
Total | 94,243 | 275,789 |
Gross Unrealized Losses | ||
In an Unrealized Loss Position Less than 12 Months | (39) | (606) |
In an Unrealized Loss Position 12 Months or Greater | (136) | (251) |
Total | $ (175) | (857) |
Commercial paper | ||
Fair Value | ||
In an Unrealized Loss Position Less than 12 Months | 7,091 | |
In an Unrealized Loss Position 12 Months or Greater | 0 | |
Total | 7,091 | |
Gross Unrealized Losses | ||
In an Unrealized Loss Position Less than 12 Months | (1) | |
In an Unrealized Loss Position 12 Months or Greater | 0 | |
Total | $ (1) |
Cash and Investments - Narrativ
Cash and Investments - Narrative (Details) | 3 Months Ended | 9 Months Ended | ||
Mar. 29, 2019USD ($)investment | Mar. 30, 2018USD ($) | Sep. 28, 2018USD ($) | Dec. 28, 2018USD ($)investment | |
Investments, Debt and Equity Securities [Abstract] | ||||
Gain (loss) on sales of investments available-for-sale | $ 0 | $ 0 | ||
Number of investments in an unrealized loss position | investment | 69 | 199 | ||
Other-than-temporary impairment charges on available-for-sale securities | $ 0 | $ 0 | ||
Beneficial ownership interest by BlackRock (more than) | 10.00% | |||
Fair value of cash and investments managed by BlackRock | $ 356,000,000 | $ 298,500,000 | ||
Fair value of cash and investments managed by BlackRock in the BlackRock Liquidity Money Market Fund | $ 800,000 | $ 3,000,000 | ||
Fees for advisory services paid to BlackRock | $ 100,000 |
Cash and Investments - Fair V_2
Cash and Investments - Fair Value of Cash Equivalents and Investments by Contractual Maturity (Details) - USD ($) $ in Thousands | Mar. 29, 2019 | Dec. 28, 2018 |
Investments, Debt and Equity Securities [Abstract] | ||
Maturing in one year or less | $ 784,432 | $ 674,455 |
Maturing after one year through five years | 207,928 | 153,687 |
Total | $ 992,360 | $ 828,142 |
Inventory (Details)
Inventory (Details) - USD ($) | 3 Months Ended | ||
Mar. 29, 2019 | Mar. 30, 2018 | Dec. 28, 2018 | |
Inventory [Line Items] | |||
Raw materials | $ 2,245,000 | $ 1,922,000 | |
Work in process | 6,514,000 | 6,170,000 | |
Finished goods | 4,862,000 | 3,836,000 | |
Total | 13,621,000 | 11,928,000 | |
Write-downs on inventory | 200,000 | $ 0 | |
Current portion included in Inventory | |||
Inventory [Line Items] | |||
Total | 10,143,000 | 9,838,000 | |
Long-term portion included in Other long-term assets | |||
Inventory [Line Items] | |||
Total | $ 3,478,000 | $ 2,090,000 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) $ in Thousands | Mar. 29, 2019 | Dec. 28, 2018 | |
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | $ 69,824 | $ 68,206 | |
Less: accumulated depreciation and amortization | (19,271) | (17,309) | |
Property and equipment, net | 50,553 | 50,897 | [1] |
Leasehold improvements | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | 33,811 | 33,941 | |
Computer equipment and software | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | 15,110 | 15,022 | |
Furniture and fixtures | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | 12,908 | 12,709 | |
Laboratory equipment | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | 6,764 | 5,668 | |
Construction in progress | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | $ 1,231 | $ 866 | |
[1] | The Condensed Consolidated Balance Sheet as of December 31, 2018 has been derived from the audited financial statements as of that date. |
Property and Equipment - Narrat
Property and Equipment - Narrative (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 29, 2019 | Mar. 30, 2018 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expense | $ 2 | $ 0.4 |
Stock-Based Compensation - Allo
Stock-Based Compensation - Allocated Employee Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 29, 2019 | Mar. 30, 2018 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Stock-based compensation | $ 12,529 | $ 9,305 |
Research and development | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Stock-based compensation | 4,306 | 3,033 |
Selling, general and administrative | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Stock-based compensation | $ 8,223 | $ 6,272 |
Stock-Based Compensation - Narr
Stock-Based Compensation - Narrative (Details) $ in Millions | 3 Months Ended |
Mar. 29, 2019USD ($)shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of shares available for grant (in shares) | shares | 14,586,459 |
Stock Options | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unrecognized compensation expense | $ | $ 44.1 |
Weighted-average cost recognition period | 2 years 5 months 26 days |
PSUs | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unrecognized compensation expense | $ | $ 12.7 |
RSUs awarded (in shares) | shares | 693,131 |
RSUs | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unrecognized compensation expense | $ | $ 77 |
Weighted-average cost recognition period | 2 years 11 months 1 day |
RSUs awarded (in shares) | shares | 123,410 |
Stock-Based Compensation - Weig
Stock-Based Compensation - Weighted Average Grant-Date Fair Value of Stock Options and ESPP Purchases (Details) - $ / shares | 3 Months Ended | |
Mar. 29, 2019 | Mar. 30, 2018 | |
Stock options | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Weighted average grant-date fair value (in dollars per share) | $ 9.21 | $ 11.52 |
ESPP | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Weighted average grant-date fair value (in dollars per share) | $ 4.67 | $ 7.39 |
Stock-Based Compensation - Valu
Stock-Based Compensation - Valuation Assumptions Used to Estimate Grant-Date Fair Value (Details) | 3 Months Ended | |
Mar. 29, 2019 | Mar. 30, 2018 | |
Stock options | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate | 2.22% | 2.40% |
Dividend yield | 0.00% | 0.00% |
Expected volatility | 49.00% | 54.00% |
Expected life | 3 years 11 months 19 days | 3 years 11 months 23 days |
ESPP | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate | 2.48% | 1.53% |
Dividend yield | 0.00% | 0.00% |
Expected volatility | 57.00% | 53.00% |
Expected life | 6 months | 6 months |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock Option Activity (Details) $ / shares in Units, $ in Thousands | 3 Months Ended |
Mar. 29, 2019USD ($)$ / sharesshares | |
Shares | |
Options outstanding at beginning of period (in shares) | shares | 22,674,062 |
Granted (in shares) | shares | 246,820 |
Exercised (in shares) | shares | (1,413,766) |
Forfeited (in shares) | shares | (44,200) |
Expired (in shares) | shares | (22,925) |
Options outstanding at end of period (in shares) | shares | 21,439,991 |
Exercisable at end of period (in shares) | shares | 15,714,721 |
Weighted Average Exercise Price Per Share | |
Options outstanding at beginning of period (in dollars per share) | $ / shares | $ 8.71 |
Granted (in dollars per share) | $ / shares | 22.94 |
Exercised (in dollars per share) | $ / shares | 4.91 |
Forfeited (in dollars per share) | $ / shares | 14.32 |
Expired (in dollars per share) | $ / shares | 22.12 |
Options outstanding at end of period (in dollars per share) | $ / shares | 9.10 |
Exercisable at end of period (in dollars per share) | $ / shares | $ 6.01 |
Weighted Average Remaining Contractual Term | |
Options outstanding at end of period | 3 years 7 months 13 days |
Exercisable at end of period | 2 years 10 months 24 days |
Aggregate Intrinsic Value | |
Options outstanding at end of period | $ | $ 317,143 |
Exercisable at end of period | $ | $ 280,307 |
Stock-Based Compensation - RSU
Stock-Based Compensation - RSU Activity (Details) - RSUs $ / shares in Units, $ in Thousands | 3 Months Ended |
Mar. 29, 2019USD ($)$ / sharesshares | |
Shares | |
RSUs outstanding at beginning of period (in shares) | shares | 4,857,334 |
Awarded (in shares) | shares | 123,410 |
Vested and released (in shares) | shares | (194,296) |
Forfeited (in shares) | shares | (100,630) |
RSUs outstanding at end of period (in shares) | shares | 4,685,818 |
Weighted Average Grant Date Fair Value Per Share | |
RSUs outstanding at beginning of period (in dollars per share) | $ / shares | $ 18.42 |
Awarded (in dollars per share) | $ / shares | 22.94 |
Vested and released (in dollars per share) | $ / shares | 7.83 |
Forfeited (in dollars per share) | $ / shares | 18.13 |
RSUs outstanding at end of period (in dollars per share) | $ / shares | $ 18.98 |
Weighted Average Remaining Contractual Term | |
RSUs outstanding at end of period | 2 years |
Aggregate Intrinsic Value | |
RSUs outstanding at end of period | $ | $ 111,522 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 29, 2019 | Mar. 30, 2018 | |
Income Tax Disclosure [Abstract] | ||
Effective Income Tax Rate Reconciliation, Percent | 16.40% | 2.10% |
Provision for income taxes | $ 14,896 | $ 2,514 |
Net Income Per Share - Computat
Net Income Per Share - Computation of Basic and Diluted Net Income Per Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 29, 2019 | Mar. 30, 2018 | |
Numerator: | ||
Net income | $ 75,775 | $ 115,857 |
Denominator: | ||
Weighted-average shares of common stock outstanding used in computing basic net income per share (in shares) | 300,542 | 296,421 |
Dilutive securities (in shares) | 14,102 | 17,270 |
Weighted-average shares of common stock outstanding and dilutive securities used in computing diluted net income per share (in shares) | 314,644 | 313,691 |
Net income per share, basic (in dollars per share) | $ 0.25 | $ 0.39 |
Net income per share, diluted (in dollars per share) | $ 0.24 | $ 0.37 |
Net Income Per Share - Potentia
Net Income Per Share - Potential Shares of Common Stock Not Included in the Computation of Diluted Net Income (Loss) Per Share (Details) - shares shares in Thousands | 3 Months Ended | |
Mar. 29, 2019 | Mar. 30, 2018 | |
Potentially dilutive securities | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive shares (in shares) | 5,089 | 1,907 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) $ in Thousands | Mar. 29, 2019 | Dec. 28, 2018 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total investments available-for-sale | $ 992,360 | $ 828,142 |
Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total investments available-for-sale | 992,360 | 828,142 |
Financial assets | 1,018,350 | 844,738 |
Level 1 | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total investments available-for-sale | 75,171 | 47,744 |
Financial assets | 75,171 | 47,744 |
Level 2 | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total investments available-for-sale | 917,189 | 780,398 |
Financial assets | 943,179 | 796,994 |
Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total investments available-for-sale | 75,171 | 47,744 |
Money market funds | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total investments available-for-sale | 75,171 | 47,744 |
Money market funds | Level 1 | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total investments available-for-sale | 75,171 | 47,744 |
Money market funds | Level 2 | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total investments available-for-sale | 0 | 0 |
Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total investments available-for-sale | 414,317 | 381,133 |
Commercial paper | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total investments available-for-sale | 414,317 | 381,133 |
Commercial paper | Level 1 | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total investments available-for-sale | 0 | 0 |
Commercial paper | Level 2 | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total investments available-for-sale | 414,317 | 381,133 |
Corporate bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total investments available-for-sale | 418,385 | 344,064 |
Corporate bonds | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total investments available-for-sale | 418,385 | 344,064 |
Corporate bonds | Level 1 | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total investments available-for-sale | 0 | 0 |
Corporate bonds | Level 2 | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total investments available-for-sale | 418,385 | 344,064 |
U.S. Treasury and government sponsored enterprises | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total investments available-for-sale | 84,487 | 55,201 |
U.S. Treasury and government sponsored enterprises | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total investments available-for-sale | 84,487 | 55,201 |
U.S. Treasury and government sponsored enterprises | Level 1 | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total investments available-for-sale | 0 | 0 |
U.S. Treasury and government sponsored enterprises | Level 2 | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total investments available-for-sale | 84,487 | 55,201 |
Certificates of deposit | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Certificates of deposit | 25,990 | 16,596 |
Certificates of deposit | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Certificates of deposit | 25,990 | 16,596 |
Certificates of deposit | Level 1 | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Certificates of deposit | 0 | 0 |
Certificates of deposit | Level 2 | Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Certificates of deposit | $ 25,990 | $ 16,596 |
Subsequent Event (Details)
Subsequent Event (Details) | Apr. 29, 2019USD ($) | Apr. 15, 2019USD ($)ft² | Dec. 28, 2018USD ($) | Apr. 01, 2019USD ($)ft² |
Collaborative Arrangement with Takeda | ||||
Subsequent Event [Line Items] | ||||
Milestone payments earned | $ 10,000,000 | |||
Subsequent Event | Collaborative Arrangement with Takeda | ||||
Subsequent Event [Line Items] | ||||
Limit on reimbursement per year | $ 1,000,000 | |||
Increase in maximum amount eligible for development and regulatory milestones | 12,000,000 | |||
Maximum amount eligible for development and regulatory milestones | 102,000,000 | |||
Milestone payments earned | 16,000,000 | |||
Increase in maximum amount eligible for commercial milestones under collaborations agreement | 3,000,000 | |||
Maximum amount eligible for commercial milestones under collaborations agreement | $ 86,000,000 | |||
Subsequent Event | Corporate Headquarters, Alameda, California | ||||
Subsequent Event [Line Items] | ||||
Operating lease, expansion (in square feet) | ft² | 37,544 | |||
Operating lease, surrendered (in square feet) | ft² | 2,703 | |||
Tenant improvement allowance | $ 1,700,000 | |||
Area of lease property (in square feet) | ft² | 169,606 | |||
Aggregate contractual base rent | $ 34,600,000 | |||
Subsequent Event | Corporate Headquarters, Alameda, California | Minimum | ||||
Subsequent Event [Line Items] | ||||
Monthly base rent | 224,505 | |||
Operating lease, not yet commenced, monthly base rent | 71,334 | |||
Subsequent Event | Corporate Headquarters, Alameda, California | Maximum | ||||
Subsequent Event [Line Items] | ||||
Monthly base rent | 283,933 | |||
Operating lease, not yet commenced, monthly base rent | $ 90,481 |
Uncategorized Items - exel-2019
Label | Element | Value |
Accounting Standards Update 2016-09 [Member] | ||
Cumulative Effect of New Accounting Principle in Period of Adoption | us-gaap_CumulativeEffectOfNewAccountingPrincipleInPeriodOfAdoption | $ 258,505,000 |
Accounting Standards Update 2016-09 [Member] | Retained Earnings [Member] | ||
Cumulative Effect of New Accounting Principle in Period of Adoption | us-gaap_CumulativeEffectOfNewAccountingPrincipleInPeriodOfAdoption | $ 258,505,000 |