Document_and_Entity_Informatio
Document and Entity Information | 9 Months Ended | |
Sep. 30, 2014 | Oct. 31, 2014 | |
Document Information [Line Items] | ' | ' |
Document Type | '10-Q | ' |
Amendment Flag | 'false | ' |
Document Period End Date | 30-Sep-14 | ' |
Document Fiscal Year Focus | '2014 | ' |
Document Fiscal Period Focus | 'Q3 | ' |
Trading Symbol | 'CLVS | ' |
Entity Registrant Name | 'CLOVIS ONCOLOGY, INC. | ' |
Entity Central Index Key | '0001466301 | ' |
Current Fiscal Year End Date | '--12-31 | ' |
Entity Filer Category | 'Large Accelerated Filer | ' |
Entity Common Stock, Shares Outstanding | ' | 33,964,440 |
Consolidated_Statements_of_Ope
Consolidated Statements of Operations and Comprehensive Loss (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, except Per Share data, unless otherwise specified | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 |
Revenues: | ' | ' | ' | ' |
License and milestone revenue | ' | ' | $13,625 | ' |
Operating expenses: | ' | ' | ' | ' |
Research and development | 34,965 | 16,063 | 87,556 | 44,001 |
General and administrative | 5,267 | 4,312 | 15,852 | 11,022 |
Acquired in-process research and development | ' | ' | 8,806 | 250 |
Amortization of intangible asset | ' | ' | 3,409 | ' |
Accretion of contingent purchase consideration | 888 | ' | 2,571 | ' |
Total expenses | 41,120 | 20,375 | 118,194 | 55,273 |
Operating loss | -41,120 | -20,375 | -104,569 | -55,273 |
Other income (expense), net | 1,770 | 55 | 1,934 | -56 |
Loss before income taxes | -39,350 | -20,320 | -102,635 | -55,329 |
Income tax expense | -292 | ' | -2,489 | ' |
Net loss | -39,642 | -20,320 | -105,124 | -55,329 |
Basic and diluted net loss per common share | ($1.17) | ($0.68) | ($3.10) | ($2) |
Basic and diluted weighted average common shares outstanding | 33,921 | 30,047 | 33,871 | 27,614 |
Comprehensive loss | ($58,809) | ($20,299) | ($126,126) | ($55,314) |
Consolidated_Balance_Sheets
Consolidated Balance Sheets (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Current assets: | ' | ' |
Cash and cash equivalents | $516,585 | $323,228 |
Prepaid research and development expenses | 2,241 | 976 |
Other current assets | 7,925 | 4,392 |
Total current assets | 526,751 | 328,596 |
Property and equipment, net | 2,846 | 955 |
Intangible assets | 220,723 | 244,518 |
Goodwill | 68,482 | 74,811 |
Other assets | 12,725 | 755 |
Total assets | 831,527 | 649,635 |
Current liabilities: | ' | ' |
Accounts payable | 2,428 | 4,420 |
Accrued research and development expenses | 23,832 | 12,548 |
Other accrued expenses | 4,719 | 3,984 |
Total current liabilities | 30,979 | 20,952 |
Contingent purchase consideration | 55,445 | 55,754 |
Deferred income taxes, net | 69,307 | 74,955 |
Convertible senior notes | 287,500 | ' |
Other non-current liabilities | 6 | 88 |
Total liabilities | 443,237 | 151,749 |
Commitments and contingencies (Note 14) | ' | ' |
Stockholders' equity: | ' | ' |
Preferred stock, par value $0.001 per share; 10,000,000 shares authorized, no shares issued and outstanding at September 30, 2014 and December 31, 2013 | ' | ' |
Common stock, $0.001 par value per share, 100,000,000 shares authorized at September 30, 2014 and December 31, 2013; 33,964,065 and 33,897,321 shares issued and outstanding at September 30, 2014 and December 31, 2013, respectively | 34 | 34 |
Additional paid-in capital | 778,700 | 762,170 |
Accumulated other comprehensive (loss) income | -16,306 | 4,696 |
Accumulated deficit | -374,138 | -269,014 |
Total stockholders' equity | 388,290 | 497,886 |
Total liabilities and stockholders' equity | $831,527 | $649,635 |
Consolidated_Balance_Sheets_Pa
Consolidated Balance Sheets (Parenthetical) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
Preferred stock, par value | $0.00 | $0.00 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $0.00 | $0.00 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 33,964,065 | 33,897,321 |
Common stock, shares outstanding | 33,964,065 | 33,897,321 |
Consolidated_Statements_of_Cas
Consolidated Statements of Cash Flows (USD $) | 9 Months Ended | |
In Thousands, unless otherwise specified | Sep. 30, 2014 | Sep. 30, 2013 |
Operating activities | ' | ' |
Net loss | ($105,124) | ($55,329) |
Adjustments to reconcile net loss to net cash used in operating activities: | ' | ' |
Depreciation and amortization | 3,772 | 185 |
Share-based compensation expense | 15,585 | 6,663 |
Change in value of contingent purchase consideration | -309 | ' |
Deferred income taxes | 761 | ' |
Changes in operating assets and liabilities, net of acquisition of a business: | ' | ' |
Prepaid and accrued research and development expenses | 7,152 | 1,990 |
Other operating assets | -3,941 | -5 |
Accounts payable | -1,889 | -1,463 |
Other accrued expenses | 892 | 81 |
Net cash used in operating activities | -83,101 | -47,878 |
Investing activities | ' | ' |
Purchases of property and equipment | -2,191 | -80 |
Net cash used in investing activities | -2,191 | -80 |
Financing activities | ' | ' |
Proceeds from the issuance of convertible senior notes | 287,500 | ' |
Proceeds from the sale of common stock, net of issuance costs | ' | 259,071 |
Proceeds from exercise of stock options and employee stock purchases | 763 | 1,403 |
Payment of debt issuance costs | -9,165 | ' |
Net cash provided by financing activities | 279,098 | 260,474 |
Effect of exchange rate changes on cash and cash equivalents | -449 | 11 |
Increase in cash and cash equivalents | 193,357 | 212,527 |
Cash and cash equivalents at beginning of period | 323,228 | 144,097 |
Cash and cash equivalents at end of period | $516,585 | $356,624 |
Nature_of_Business_and_Basis_o
Nature of Business and Basis of Presentation | 9 Months Ended |
Sep. 30, 2014 | |
Nature of Business and Basis of Presentation | ' |
1. Nature of Business and Basis of Presentation | |
Clovis Oncology, Inc. (the “Company”) commenced operations in May 2009. The Company is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the United States, Europe and other international markets. The Company has and intends to continue to license or acquire rights to oncology compounds in all stages of development. In exchange for the right to develop and commercialize these compounds, the Company generally expects to provide the licensor with a combination of up-front payments, milestone payments and royalties on future sales. In addition, the Company generally expects to assume the responsibility for future drug development and commercialization costs. The Company currently operates in one segment. Since inception, the Company’s operations have consisted primarily of developing in-licensed compounds, evaluating new product acquisition candidates and general corporate activities. In the first quarter of 2014, the Company exited the development stage, with the recognition of $13.6 million in license and milestone revenue related to its lucitanib collaboration and license agreement with Les Laboratoires Servier (“Servier”). The license and milestone revenue recognized is the first significant revenue from principal operations and therefore, the Company is no longer considered a development stage company. | |
Basis of Presentation | |
All financial information presented includes the accounts of the Company’s wholly-owned subsidiaries. All significant intercompany balances and transactions have been eliminated in consolidation. The unaudited financial statements of Clovis Oncology, Inc. included herein reflect all adjustments, consisting only of normal recurring adjustments, which in the opinion of management are necessary to fairly state our financial position, results of operations and cash flows for the periods presented. Interim results may not be indicative of the results that may be expected for the full year. Certain information and footnote disclosures normally included in audited financial statements prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) have been condensed or omitted pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). These financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto which are included in our Annual Report on Form 10-K for the year ended December 31, 2013 for a broader discussion of our business and the opportunities and risks inherent in such business. | |
Use of Estimates | |
The preparation of these financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, expenses, revenue and related disclosures. On an ongoing basis, management evaluates its estimates, including estimates related to contingent purchase consideration, the allocation of purchase consideration, intangible assets, clinical trial accruals and share-based compensation expense. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. Actual results may differ from those estimates or assumptions. | |
Liquidity | |
The Company has incurred significant net losses since inception and has relied on its ability to fund its operations through debt and equity financings. Management expects operating losses and negative cash flows to continue for the foreseeable future. As the Company continues to incur losses, transition to profitability is dependent upon the successful development, approval and commercialization of its product candidates and achieving a level of revenues adequate to support the Company’s cost structure. The Company may never achieve profitability, and unless or until it does, the Company will continue to need to raise additional cash. Management intends to fund future operations through additional private or public debt or equity offerings and may seek additional capital through arrangements with strategic partners or from other sources. |
Summary_of_Significant_Account
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2014 | |
Summary of Significant Accounting Policies | ' |
2. Summary of Significant Accounting Policies | |
The Company’s significant accounting policies are described in Note 2 of the Notes to the Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2013. | |
Recent Accounting Pronouncements | |
In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09, “Revenue from Contracts with Customers (Topic 606).” ASU 2014-09 specifies the accounting for revenue from contracts with customers and establishes disclosure requirements relating to the nature, timing and uncertainty of revenue and cash flows arising from an entity’s contracts with customers. This update is effective for annual and interim periods beginning after December 15, 2016 and allows for either full retrospective or modified retrospective adoption. Early adoption is not permitted. The Company is currently evaluating its planned method of adoption and the impact the standard may have on its consolidated financial statements and related disclosures. | |
In August 2014, the FASB issued ASU No. 2014-15, “Disclosure of Uncertainties About an Entity’s Ability to Continue as a Going Concern,” which requires management to evaluate whether there are conditions or events that raise substantial doubt about an entity’s ability to continue as a going concern and to provide disclosures when certain criteria are met. The guidance is effective for annual periods beginning in 2016 and interim reporting periods starting in the first quarter of 2017. Early application is permitted. The Company does not expect the standard will have an impact on its disclosures. |
EOS_Acquisition
EOS Acquisition | 9 Months Ended |
Sep. 30, 2014 | |
EOS Acquisition | ' |
3. EOS Acquisition | |
On November 19, 2013, the Company acquired all of the outstanding common and preferred stock of Ethical Oncology Science, S.p.A. (“EOS”). The initial purchase consideration was comprised of a cash payment of $11.8 million and the issuance of $173.7 million of the Company’s common stock to the former EOS shareholders. The Company may make additional purchase payments to the previous EOS shareholders if certain lucitanib regulatory and sales milestones are achieved. The range of the potential contingent milestone payments are zero to an estimated maximum of $65.0 million and €115.0 million. The Company recorded a liability for the estimated fair value of these payments, which totaled $55.4 million and $55.8 million at September 30, 2014 and December 31, 2013, respectively. |
Financial_Instruments_and_Fair
Financial Instruments and Fair Value Measurement | 9 Months Ended | ||||||||||||||||
Sep. 30, 2014 | |||||||||||||||||
Financial Instruments and Fair Value Measurement | ' | ||||||||||||||||
4. Financial Instruments and Fair Value Measurement | |||||||||||||||||
Cash, Cash Equivalents and Marketable Securities | |||||||||||||||||
The Company considers all highly liquid investments with original maturities at the date of purchase of three months or less to be cash equivalents. Cash and cash equivalents include bank demand deposits and money market funds that invest primarily in certificate of deposits, commercial paper and U.S. government and U.S. government agency obligations. | |||||||||||||||||
Marketable securities with original maturities greater than three months are considered to be available-for-sale securities and historically consisted of U.S. agency obligations, U.S. government obligations and corporate debt obligations. Available-for-sale securities are reported at fair value and unrealized gains and losses are included in accumulated other comprehensive income on the Consolidated Balance Sheets. Realized gains and losses, amortization of premiums and discounts and interest and dividends earned are included in other income (expense), net on the Consolidated Statements of Operations and Comprehensive Loss. The cost of investments for purposes of computing realized and unrealized gains and losses is based on the specific identification method. Investments with maturities beyond one year are classified as short-term based on management’s intent to fund current operations with these securities or to make them available for current operations. A decline in the market value of a security below its cost value that is deemed to be other than temporary is charged to earnings and results in the establishment of a new cost basis for the security. | |||||||||||||||||
Fair Value of Financial Instruments | |||||||||||||||||
Fair value is defined as the exchange price that would be received to sell an asset or paid to transfer a liability (at exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The three levels of inputs that may be used to measure fair value include: | |||||||||||||||||
Level 1: | Quoted prices in active markets for identical assets or liabilities. The Company’s Level 1 assets consist of money market investments. The Company does not have Level 1 liabilities. | ||||||||||||||||
Level 2: | Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities in active markets or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. The Company does not have Level 2 assets or liabilities. | ||||||||||||||||
Level 3: | Unobservable inputs that are supported by little or no market activity. The Company does not have Level 3 assets. The contingent purchase consideration related to the undeveloped lucitanib product rights acquired in 2013 with the purchase of EOS is a Level 3 liability. The fair value of this liability is based on unobservable inputs and includes valuations for which there is little, if any, market activity. See Note 3 of the Company’s 2013 Form 10-K for further discussion of the unobservable inputs and valuation techniques related to the contingent purchase consideration liability. | ||||||||||||||||
The following table identifies the Company’s assets and liabilities that were measured at fair value on a recurring basis (in thousands): | |||||||||||||||||
Balance | Level 1 | Level 2 | Level 3 | ||||||||||||||
September 30, 2014 | |||||||||||||||||
Assets: | |||||||||||||||||
Money market | $ | 447,986 | $ | 447,986 | $ | — | $ | — | |||||||||
Total assets at fair value | $ | 447,986 | $ | 447,986 | $ | — | $ | — | |||||||||
Liabilities: | |||||||||||||||||
Contingent purchase consideration | $ | 55,445 | $ | — | $ | — | $ | 55,445 | |||||||||
Total liabilities at fair value | $ | 55,445 | $ | — | $ | — | $ | 55,445 | |||||||||
December 31, 2013 | |||||||||||||||||
Assets: | |||||||||||||||||
Money market | $ | 318,886 | $ | 318,886 | $ | — | $ | — | |||||||||
Total assets at fair value | $ | 318,886 | $ | 318,886 | $ | — | $ | — | |||||||||
Liabilities: | |||||||||||||||||
Contingent purchase consideration | $ | 55,754 | $ | — | $ | — | $ | 55,754 | |||||||||
Total liabilities at fair value | $ | 55,754 | $ | — | $ | — | $ | 55,754 | |||||||||
There were no transfers between Level 1 and Level 2 during the nine months ended September 30, 2014. | |||||||||||||||||
The following table rolls forward the fair value of Level 3 instruments (significant unobservable inputs) in thousands: | |||||||||||||||||
For the Nine | |||||||||||||||||
Months Ended | |||||||||||||||||
September 30, 2014 | |||||||||||||||||
Liabilities: | |||||||||||||||||
Balance at beginning of period | $ | 55,754 | |||||||||||||||
Accretion | 2,571 | ||||||||||||||||
Change in foreign currency gains and losses | (2,880 | ) | |||||||||||||||
Balance at end of period | $ | 55,445 | |||||||||||||||
The change in the fair value of Level 3 instruments is included in accretion of contingent purchase consideration and other income (expense), net for the change in foreign currency gains and losses on the Consolidated Statements of Operations and Comprehensive Loss. |
Other_Current_Assets
Other Current Assets | 9 Months Ended | ||||||||
Sep. 30, 2014 | |||||||||
Other Current Assets | ' | ||||||||
5. Other Current Assets | |||||||||
Other current assets are comprised of the following (in thousands): | |||||||||
September 30, 2014 | December 31, 2013 | ||||||||
Receivable from partners | $ | 6,544 | $ | 2,921 | |||||
VAT recoverable | 45 | 950 | |||||||
Prepaid expenses and other | 1,336 | 521 | |||||||
Other current assets | $ | 7,925 | $ | 4,392 | |||||
Intangible_Assets_and_Goodwill
Intangible Assets and Goodwill | 9 Months Ended |
Sep. 30, 2014 | |
Intangible Assets and Goodwill | ' |
6. Intangible Assets and Goodwill | |
Intangible acquired in-process research and development (“IPR&D”) assets were established as part of the purchase accounting of EOS in November 2013. The intangible asset balance at September 30, 2014 and December 31, 2013 was $220.7 million and $244.5 million, respectively. The balance decreased $20.4 million over the prior year due to changes in foreign currency translation rates. In addition, the Company recorded a $3.4 million reduction in the intangible assets driven by lower expected future milestone revenue cash flows from our lucitanib development activities due to the receipt of a lucitanib milestone payment from Servier during the first quarter of 2014. This reduction was reported as amortization of intangible asset on the Consolidated Statements of Operations and Comprehensive Loss. | |
Recurring amortization of these assets will commence when the useful lives of the intangible assets have been determined. IPR&D intangible assets are evaluated for impairment at least annually or more frequently if impairment indicators exist and any reduction in fair value will be recognized as an expense in the Consolidated Statements of Operations and Comprehensive Loss. | |
The acquisition of EOS in November 2013 generated a goodwill balance of $74.8 million at December 31, 2013. This balance decreased to $68.5 million at September 30, 2014 due to changes in foreign currency translation rates. |
Other_Accrued_Expenses
Other Accrued Expenses | 9 Months Ended | ||||||||
Sep. 30, 2014 | |||||||||
Other Accrued Expenses | ' | ||||||||
7. Other Accrued Expenses | |||||||||
Other accrued expenses are comprised of the following (in thousands): | |||||||||
September 30, 2014 | December 31, 2013 | ||||||||
Accrued personnel costs | $ | 3,404 | $ | 3,356 | |||||
Accrued corporate legal fees and professional services | 132 | 257 | |||||||
Accrued expenses – other | 1,183 | 371 | |||||||
Other accrued expenses | $ | 4,719 | $ | 3,984 | |||||
Convertible_Senior_Notes
Convertible Senior Notes | 9 Months Ended | ||||||||
Sep. 30, 2014 | |||||||||
Convertible Senior Notes | ' | ||||||||
8. Convertible Senior Notes | |||||||||
On September 9, 2014, we completed a private placement of $287.5 million aggregate principal amount of 2.5% convertible senior notes due 2021 (the “Notes”) resulting in net proceeds to the Company of $278.3 million after deducting offering expenses. In accordance with the accounting guidance, the conversion feature did not meet the criteria for bifurcation, and the entire principal amount was recorded as a long-term liability on the Consolidated Balance Sheets. | |||||||||
The Notes are governed by the terms of the indenture between the Company, as issuer, and The Bank of New York Mellon Trust Company, N.A., as trustee. The Notes are senior unsecured obligations and bear interest at a rate of 2.5% per year, payable semi-annually in arrears on March 15 and September 15 of each year, beginning March 15, 2015. The Notes will mature on September 15, 2021, unless earlier converted, redeemed or repurchased. | |||||||||
Holders may convert all or any portion of the Notes at any time prior to the close of business on the business day immediately preceding the maturity date. Upon conversion, the holders will receive shares of our common stock at an initial conversion rate of 16.1616 shares per $1,000 in principal amount of Notes, equivalent to a conversion price of approximately $61.88 per share. The conversion rate is subject to adjustment upon the occurrence of certain events described in the indenture, but will not be adjusted for any accrued and unpaid interest. In addition, following certain corporate events that occur prior to the maturity date or upon our issuance of a notice of redemption, we will increase the conversion rate for holders who elect to convert the Notes in connection with such a corporate event or during the related redemption period in certain circumstances. | |||||||||
On or after September 15, 2018, we may redeem the Notes, at our option, in whole or in part, if the last reported sale price of our common stock has been at least 150% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period ending not more than two trading days preceding the date on which we provide written notice of redemption at a redemption price equal to 100% of the principal amount of the Notes to be redeemed plus accrued and unpaid interest to, but excluding, the redemption date. No sinking fund is provided for the Notes. | |||||||||
If we undergo a fundamental change, as defined in the indenture, prior to the maturity date of the Notes, holders may require us to repurchase for cash all or any portion of the Notes at a fundamental change repurchase price equal to 100% of the principal amount of the Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. | |||||||||
The Notes rank senior in right of payment to any of our indebtedness that is expressly subordinated in right of payment to the Notes; equal in right of payment to all of our liabilities that are not so subordinated; effectively junior in right of payment to any secured indebtedness to the extent of the value of the assets securing such indebtedness; and structurally junior to all indebtedness and other liabilities (including trade payables) of our subsidiaries. | |||||||||
In connection with the issuance of the Notes, the Company incurred $9.2 million of debt issuance costs, which is included in other assets on the Consolidated Balance Sheets. The debt issuance costs are amortized as interest expense over the expected life of the Notes using the effective interest method. The Company determined the expected life of the debt was equal to the seven-year term of the Notes. As of September 30, 2014, the balance of unamortized debt issuance costs was $9.1 million. | |||||||||
The fair value of the Notes was $297.3 million at September 30, 2014 and was determined using Level 2 inputs based on the indicative pricing published by certain investment banks or trading levels of the Notes, which are not listed on any securities exchange or quoted on an inter-dealer automated quotation system. | |||||||||
The following table sets forth total interest expense, included in other income (expense), net on the Consolidated Statements of Operations and Comprehensive Loss, recognized related to the Notes during the three and nine months ended September 30, 2014 (in thousands): | |||||||||
Three Months Ended | Nine Months Ended | ||||||||
September 30, 2014 | September 30, 2014 | ||||||||
Contractual interest expense | $ | 439 | $ | 439 | |||||
Amortization of debt issuance costs | 72 | 72 | |||||||
Total interest expense | $ | 511 | $ | 511 | |||||
Stockholders_Equity
Stockholders' Equity | 9 Months Ended | ||||||||
Sep. 30, 2014 | |||||||||
Stockholders' Equity | ' | ||||||||
9. Stockholders’ Equity | |||||||||
Common Stock | |||||||||
In June 2013, the Company sold 3,819,444 shares of its common stock in a public offering at $72.00 per share. The net offering proceeds realized after deducting offering expenses and underwriters’ discounts and commissions were $259.1 million. | |||||||||
Accumulated Other Comprehensive Income (Loss) | |||||||||
The accumulated balances related to each component of other comprehensive income (loss) are summarized as follows (in thousands): | |||||||||
Foreign | Total | ||||||||
Currency | Accumulated | ||||||||
Translation | Other | ||||||||
Adjustments | Comprehensive | ||||||||
Income (Loss) | |||||||||
Balance December 31, 2013 | $ | 4,696 | $ | 4,696 | |||||
Period change | (21,002 | ) | (21,002 | ) | |||||
Balance September 30, 2014 | $ | (16,306 | ) | $ | (16,306 | ) | |||
Balance December 31, 2012 | $ | 53 | $ | 53 | |||||
Period change | 4,643 | 4,643 | |||||||
Balance December 31, 2013 | $ | 4,696 | $ | 4,696 | |||||
The period change between December 31, 2013 and September 30, 2014 was primarily due to the currency translation of the IPR&D intangible assets, goodwill and deferred income taxes associated with the acquisition of EOS in November 2013. |
ShareBased_Compensation
Share-Based Compensation | 9 Months Ended | ||||||||||||||||
Sep. 30, 2014 | |||||||||||||||||
Share-Based Compensation | ' | ||||||||||||||||
10. Share-Based Compensation | |||||||||||||||||
Share-based compensation expense for all equity based programs, including stock options and the employee stock purchase plan, for the three and nine months ended September 30, 2014 and 2013, respectively, was recognized in the accompanying Consolidated Statements of Operations and Comprehensive Loss as follows: | |||||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
Research and development | $ | 2,991 | $ | 1,138 | $ | 8,005 | $ | 3,095 | |||||||||
General and administrative | 2,445 | 1,653 | 7,580 | 3,568 | |||||||||||||
Total share-based compensation expense | $ | 5,436 | $ | 2,791 | $ | 15,585 | $ | 6,663 | |||||||||
The Company did not recognize a tax benefit related to share-based compensation expense during the three and nine months ended September 30, 2014 and 2013, respectively, as the Company maintains net operating loss carryforwards and has established a valuation allowance against the entire net deferred tax asset as of September 30, 2014. No share-based compensation expense was capitalized on our Consolidated Balance Sheets as of September 30, 2014 and December 31, 2013. | |||||||||||||||||
The following table summarizes the activity relating to the Company’s options to purchase common stock for the nine month period ended September 30, 2014: | |||||||||||||||||
Number of | Weighted- | Weighted- | Aggregate | ||||||||||||||
Options | Average | Average | Intrinsic | ||||||||||||||
Exercise | Remaining | Value | |||||||||||||||
Price | Contractual | ||||||||||||||||
Term (Years) | |||||||||||||||||
Outstanding at December 31, 2013 | 2,520,170 | $ | 21.19 | ||||||||||||||
Granted | 1,449,457 | 62 | |||||||||||||||
Exercised | (60,449 | ) | 8.96 | ||||||||||||||
Forfeited | (23,813 | ) | 34.96 | ||||||||||||||
Outstanding at September 30, 2014 | 3,885,365 | $ | 36.52 | 8.29 | $ | 64,790,012 | |||||||||||
Vested and expected to vest at September 30, 2014 | 3,620,712 | $ | 35.23 | 8.22 | $ | 63,341,213 | |||||||||||
Vested at September 30, 2014 | 1,503,631 | $ | 19.47 | 7.3 | $ | 41,643,182 | |||||||||||
The aggregate intrinsic value in the table above represents the pretax intrinsic value, based on our closing stock price of $45.36 as of September 30, 2014, which would have been received by the option holders had all option holders with in-the-money options exercised their options as of that date. | |||||||||||||||||
Presented in the table below are financial details associated with our stock options during the three and nine months ended September 30, 2014 and 2013: | |||||||||||||||||
Three Months Ended September 30, | |||||||||||||||||
2014 | 2013 | ||||||||||||||||
Weighted-average grant-date fair value per share | $ | 27.85 | $ | 43.43 | |||||||||||||
Intrinsic value of options exercised | $ | 4,391 | $ | 85,589 | |||||||||||||
Cash received from stock option exercises | $ | 341 | $ | 34,711 | |||||||||||||
Nine Months Ended September 30, | |||||||||||||||||
2014 | 2013 | ||||||||||||||||
Weighted-average grant-date fair value per share | $ | 39.13 | $ | 18.43 | |||||||||||||
Intrinsic value of options exercised | $ | 2,754,669 | $ | 5,801,963 | |||||||||||||
Cash received from stock option exercises | $ | 541,508 | $ | 1,223,023 | |||||||||||||
As of September 30, 2014, the unrecognized share-based compensation expense related to nonvested options, adjusted for expected forfeitures, was $51.6 million and the estimated weighted-average remaining vesting period was 3.0 years. |
License_Agreements
License Agreements | 9 Months Ended |
Sep. 30, 2014 | |
License Agreements | ' |
11. License Agreements | |
Rociletinib (CO-1686) | |
In May 2010, the Company entered into a worldwide license agreement with Avila Therapeutics, Inc. (now part of Celgene Corporation) to discover, develop and commercialize a covalent inhibitor of mutant forms of the epidermal growth factor receptor (“EGFR”) gene product. Rociletinib was identified as the lead drug candidate to be developed under the license agreement. The Company is responsible for all preclinical, clinical, regulatory and other activities necessary to develop and commercialize rociletinib. The Company made an up-front payment of $2.0 million upon execution of the license agreement and is obligated to pay royalties on net sales of rociletinib, based on the volume of annual net sales achieved. Celgene has the option to increase royalty rates by electing to reimburse a portion of the development expenses incurred by the Company. This option must be exercised within a limited period of time after Celgene is notified of our intent to pursue regulatory approval of rociletinib in the U.S. or European Union as a first line therapy. Such notice was provided to Celgene on June 4, 2014, and on September 2, 2014, we received notification from Celgene that the company elected not to exercise this option. | |
In January 2013, the Company entered into an exclusive license agreement with Gatekeeper Pharmaceuticals, Inc. (“Gatekeeper”) to acquire exclusive rights under patent applications associated with mutant EGFR inhibitors and methods of treatment. Pursuant to the terms of the license agreement, the Company made an up-front payment of $250,000 upon execution of the agreement, which was recognized as acquired in-process research and development expense. If rociletinib is approved for commercial sale, the Company will pay royalties to Gatekeeper on future net sales. | |
In February 2014, the Company initiated a Phase II study for rociletinib which resulted in a $5.0 million milestone payment to Celgene as required by the license agreement. This payment was recognized as acquired in-process research and development expense. The Company may be required to pay up to an additional aggregate of $110.0 million in development and regulatory milestone payments if certain clinical study objectives and regulatory filings, acceptances and approvals are achieved. In addition, the Company may be required to pay up to an aggregate of $120.0 million in sales milestones if certain annual sales targets are achieved. | |
Rucaparib | |
In June 2011, the Company entered into a worldwide license agreement with Pfizer Inc. to acquire exclusive development and commercialization rights to Pfizer’s drug candidate known as rucaparib. This drug candidate is a small molecule inhibitor of poly (ADP-ribose) polymerase (“PARP”), which the Company is developing for the treatment of selected solid tumors. Pursuant to the terms of the license agreement, the Company made a $7.0 million up-front payment to Pfizer. | |
In April 2014, the Company initiated a pivotal registrational study for rucaparib, which resulted in a $0.4 million milestone payment to Pfizer as required by the license agreement. This payment was recognized as acquired in-process research and development expense. | |
The Company is responsible for all development and commercialization costs of rucaparib and, if approved, Pfizer will receive royalties on the net sales of the product. In addition, Pfizer is eligible to receive up to $258.5 million of further payments, in aggregate, if certain development, regulatory and sales milestones are achieved. | |
In April 2012, the Company entered into a license agreement with AstraZeneca UK Limited to acquire exclusive rights associated with rucaparib under a family of patents and patent applications that claim methods of treating patients with PARP inhibitors in certain indications. The license enables the development and commercialization of rucaparib for the uses claimed by these patents. Pursuant to the terms of the license agreement, the Company made an up-front payment of $250,000 upon execution of the agreement, which was recognized as acquired in-process research and development expense. The Company may be required to pay up to an aggregate of $0.7 million in milestone payments if certain regulatory filings, acceptances and approvals are achieved. If approved, AstraZeneca will also receive royalties on any net sales of rucaparib. | |
Lucitanib | |
In connection with its November 2013 acquisition of EOS, the Company gained rights to develop and commercialize lucitanib, an oral, selective tyrosine kinase inhibitor. As further described below, EOS licensed the worldwide rights, excluding China, to develop and commercialize lucitanib from Advenchen Laboratories LLC (“Advenchen”). Subsequently, rights to develop and commercialize lucitanib in markets outside the U.S. and Japan were sublicensed by EOS to Servier in exchange for up-front milestone fees, royalties on sales of lucitanib in the sublicensed territories and research and development funding commitments. | |
In October 2008, EOS entered into an exclusive license agreement with Advenchen to develop and commercialize lucitanib on a global basis, excluding China. The Company is obligated to pay Advenchen royalties on net sales of lucitanib, based on the volume of annual net sales achieved. In addition, the Company is obligated to pay to Advenchen 25% of any consideration, excluding royalties, received pursuant to any sublicense agreements for lucitanib, including the agreement with Servier. In the first quarter of 2014, the Company recognized acquired in-process research and development expense of $3.4 million, which represents 25% of the sublicense agreement consideration of $13.6 million received from Servier upon the end of opposition and appeal of the lucitanib patent by the European Patent Office. | |
In September 2012, EOS entered into a collaboration and license agreement with Servier whereby EOS sublicensed to Servier exclusive rights to develop and commercialize lucitanib in all countries outside of the U.S., Japan and China. In exchange for these rights, EOS received an up-front payment and is entitled to receive additional payments upon achievement of specified development, regulatory and commercial milestones up to €90.0 million in the aggregate. In addition, the Company is entitled to receive sales milestone payments if specified annual sales targets for lucitanib are met, which, in the aggregate, could total €250.0 million. The Company is also entitled to receive royalties on net sales of lucitanib by Servier. | |
The development, regulatory and commercial milestones represent non-refundable amounts that would be paid by Servier to the Company if certain milestones are achieved in the future. These milestones, if achieved, are substantive as they relate solely to past performance, are commensurate with estimated enhancement of value associated with the achievement of each milestone as a result of the Company’s performance, which are reasonable relative to the other deliverables and terms of the arrangement, and are unrelated to the delivery of any further elements under the arrangement. | |
The Company and Servier are developing lucitanib pursuant to a development plan agreed to between the parties. Servier is responsible for all of the initial global development costs under the agreed upon plan up to €80.0 million. Cumulative global development costs, if any, in excess of €80.0 million will be shared equally between the Company and Servier. Beginning in the third quarter of 2014, depending on the expense type, reimbursements are determined using a standard rate approved by the Company and Servier or actual costs incurred. Previously, reimbursements were determined based on actual costs. Reimbursements are recorded as a reduction to research and development expense in the Consolidated Statements of Operations and Comprehensive Loss. | |
The Company recorded a $6.5 million and $2.9 million receivable at September 30, 2014 and December 31, 2013, respectively, for the reimbursable development costs incurred under the global development plan, which is included in other current assets on the Consolidated Balance Sheets. For the three and nine months ending September 30, 2014, we recorded reductions in research and development expense of $4.1 million and $7.9 million, respectively, for reimbursable development costs due from Servier. |
Net_Loss_Per_Common_Share
Net Loss Per Common Share | 9 Months Ended |
Sep. 30, 2014 | |
Net Loss Per Common Share | ' |
12. Net Loss Per Common Share | |
Basic net loss per share is calculated by dividing net loss by the weighted-average number of common shares outstanding during the period. Diluted net loss per share is computed by dividing net loss by the weighted-average number of common share equivalents outstanding using the treasury stock method for the stock options and the if-converted method for the Notes. As a result of our net losses for the periods presented, all potentially dilutive common share equivalents were considered anti-dilutive and were excluded from the computation of diluted net loss per share. |
Income_Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2014 | |
Income Taxes | ' |
13. Income Taxes | |
Income tax expense of $2.5 million was recorded during the nine months ended September 30, 2014 due to taxable income earned in a foreign jurisdiction resulting from milestone revenue received during the first quarter of 2014. This expense was partially offset by a deferred tax benefit recognized upon the write down of an intangible asset in the first quarter of 2014 (see Note 6). The Company maintains a valuation allowance against the majority of the net deferred tax assets held at September 30, 2014 and intends to maintain this valuation allowance until there is sufficient evidence that consistent future earnings can be achieved, which is uncertain at this time. |
Commitments_and_Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2014 | |
Commitments and Contingencies | ' |
14. Commitments and Contingencies | |
Royalty and License Fee Commitments | |
The Company has entered into certain license agreements, as identified in Note 11, with third parties that include the payment of development and regulatory milestones, as well as royalty payments, upon the achievement of pre-established development, regulatory and commercial targets. The Company’s payment obligation related to these license agreements is contingent upon the successful development, regulatory approval and commercialization of the licensed products. Due to the nature of these arrangements, the future potential payments are inherently uncertain, and accordingly, no amounts have been recorded in the Company’s Consolidated Balance Sheets at September 30, 2014 and December 31, 2013. | |
Development and Manufacturing Agreement Commitments | |
In February 2013, the Company entered into a development and manufacturing agreement with a third-party supplier for the production of the active ingredient for rucaparib. Under the Development and Manufacturing Agreement, the Company will provide the third-party supplier a rolling 24-month forecast that will be updated by the Company on a quarterly basis. The Company is obligated to order the quantity specified in the first 12 months of any forecast. As of September 30, 2014, no purchase commitments were established under this agreement. |
Subsequent_Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2014 | |
Subsequent Events | ' |
15. Subsequent Events | |
The Company evaluated events up to the filing date of these interim financial statements and determined that no subsequent activity required disclosure. |
Nature_of_Business_and_Basis_o1
Nature of Business and Basis of Presentation (Policies) | 9 Months Ended |
Sep. 30, 2014 | |
Basis of Presentation | ' |
Basis of Presentation | |
All financial information presented includes the accounts of the Company’s wholly-owned subsidiaries. All significant intercompany balances and transactions have been eliminated in consolidation. The unaudited financial statements of Clovis Oncology, Inc. included herein reflect all adjustments, consisting only of normal recurring adjustments, which in the opinion of management are necessary to fairly state our financial position, results of operations and cash flows for the periods presented. Interim results may not be indicative of the results that may be expected for the full year. Certain information and footnote disclosures normally included in audited financial statements prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) have been condensed or omitted pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). These financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto which are included in our Annual Report on Form 10-K for the year ended December 31, 2013 for a broader discussion of our business and the opportunities and risks inherent in such business. | |
Use of Estimates | ' |
Use of Estimates | |
The preparation of these financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, expenses, revenue and related disclosures. On an ongoing basis, management evaluates its estimates, including estimates related to contingent purchase consideration, the allocation of purchase consideration, intangible assets, clinical trial accruals and share-based compensation expense. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. Actual results may differ from those estimates or assumptions. | |
Liquidity | ' |
Liquidity | |
The Company has incurred significant net losses since inception and has relied on its ability to fund its operations through debt and equity financings. Management expects operating losses and negative cash flows to continue for the foreseeable future. As the Company continues to incur losses, transition to profitability is dependent upon the successful development, approval and commercialization of its product candidates and achieving a level of revenues adequate to support the Company’s cost structure. The Company may never achieve profitability, and unless or until it does, the Company will continue to need to raise additional cash. Management intends to fund future operations through additional private or public debt or equity offerings and may seek additional capital through arrangements with strategic partners or from other sources. | |
Recent Accounting Pronouncements | ' |
Recent Accounting Pronouncements | |
In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09, “Revenue from Contracts with Customers (Topic 606).” ASU 2014-09 specifies the accounting for revenue from contracts with customers and establishes disclosure requirements relating to the nature, timing and uncertainty of revenue and cash flows arising from an entity’s contracts with customers. This update is effective for annual and interim periods beginning after December 15, 2016 and allows for either full retrospective or modified retrospective adoption. Early adoption is not permitted. The Company is currently evaluating its planned method of adoption and the impact the standard may have on its consolidated financial statements and related disclosures. | |
In August 2014, the FASB issued ASU No. 2014-15, “Disclosure of Uncertainties About an Entity’s Ability to Continue as a Going Concern,” which requires management to evaluate whether there are conditions or events that raise substantial doubt about an entity’s ability to continue as a going concern and to provide disclosures when certain criteria are met. The guidance is effective for annual periods beginning in 2016 and interim reporting periods starting in the first quarter of 2017. Early application is permitted. The Company does not expect the standard will have an impact on its disclosures. | |
Cash, Cash Equivalents | ' |
The Company considers all highly liquid investments with original maturities at the date of purchase of three months or less to be cash equivalents. Cash and cash equivalents include bank demand deposits and money market funds that invest primarily in certificate of deposits, commercial paper and U.S. government and U.S. government agency obligations. | |
Marketable Securities | ' |
Marketable securities with original maturities greater than three months are considered to be available-for-sale securities and historically consisted of U.S. agency obligations, U.S. government obligations and corporate debt obligations. Available-for-sale securities are reported at fair value and unrealized gains and losses are included in accumulated other comprehensive income on the Consolidated Balance Sheets. Realized gains and losses, amortization of premiums and discounts and interest and dividends earned are included in other income (expense), net on the Consolidated Statements of Operations and Comprehensive Loss. The cost of investments for purposes of computing realized and unrealized gains and losses is based on the specific identification method. Investments with maturities beyond one year are classified as short-term based on management’s intent to fund current operations with these securities or to make them available for current operations. A decline in the market value of a security below its cost value that is deemed to be other than temporary is charged to earnings and results in the establishment of a new cost basis for the security. |
Financial_Instruments_and_Fair1
Financial Instruments and Fair Value Measurement (Tables) | 9 Months Ended | ||||||||||||||||
Sep. 30, 2014 | |||||||||||||||||
Assets and Liabilities Measured at Fair Value on Recurring Basis | ' | ||||||||||||||||
The following table identifies the Company’s assets and liabilities that were measured at fair value on a recurring basis (in thousands): | |||||||||||||||||
Balance | Level 1 | Level 2 | Level 3 | ||||||||||||||
September 30, 2014 | |||||||||||||||||
Assets: | |||||||||||||||||
Money market | $ | 447,986 | $ | 447,986 | $ | — | $ | — | |||||||||
Total assets at fair value | $ | 447,986 | $ | 447,986 | $ | — | $ | — | |||||||||
Liabilities: | |||||||||||||||||
Contingent purchase consideration | $ | 55,445 | $ | — | $ | — | $ | 55,445 | |||||||||
Total liabilities at fair value | $ | 55,445 | $ | — | $ | — | $ | 55,445 | |||||||||
December 31, 2013 | |||||||||||||||||
Assets: | |||||||||||||||||
Money market | $ | 318,886 | $ | 318,886 | $ | — | $ | — | |||||||||
Total assets at fair value | $ | 318,886 | $ | 318,886 | $ | — | $ | — | |||||||||
Liabilities: | |||||||||||||||||
Contingent purchase consideration | $ | 55,754 | $ | — | $ | — | $ | 55,754 | |||||||||
Total liabilities at fair value | $ | 55,754 | $ | — | $ | — | $ | 55,754 | |||||||||
Roll-forward of Fair Value of Level 3 Instruments (significant unobservable inputs) | ' | ||||||||||||||||
The following table rolls forward the fair value of Level 3 instruments (significant unobservable inputs) in thousands: | |||||||||||||||||
For the Nine | |||||||||||||||||
Months Ended | |||||||||||||||||
September 30, 2014 | |||||||||||||||||
Liabilities: | |||||||||||||||||
Balance at beginning of period | $ | 55,754 | |||||||||||||||
Accretion | 2,571 | ||||||||||||||||
Change in foreign currency gains and losses | (2,880 | ) | |||||||||||||||
Balance at end of period | $ | 55,445 | |||||||||||||||
Other_Current_Assets_Tables
Other Current Assets (Tables) | 9 Months Ended | ||||||||
Sep. 30, 2014 | |||||||||
Other Current Assets | ' | ||||||||
Other current assets are comprised of the following (in thousands): | |||||||||
September 30, 2014 | December 31, 2013 | ||||||||
Receivable from partners | $ | 6,544 | $ | 2,921 | |||||
VAT recoverable | 45 | 950 | |||||||
Prepaid expenses and other | 1,336 | 521 | |||||||
Other current assets | $ | 7,925 | $ | 4,392 | |||||
Other_Accrued_Expenses_Tables
Other Accrued Expenses (Tables) | 9 Months Ended | ||||||||
Sep. 30, 2014 | |||||||||
Other Accrued Expenses | ' | ||||||||
Other accrued expenses are comprised of the following (in thousands): | |||||||||
September 30, 2014 | December 31, 2013 | ||||||||
Accrued personnel costs | $ | 3,404 | $ | 3,356 | |||||
Accrued corporate legal fees and professional services | 132 | 257 | |||||||
Accrued expenses – other | 1,183 | 371 | |||||||
Other accrued expenses | $ | 4,719 | $ | 3,984 | |||||
Convertible_Senior_Notes_Table
Convertible Senior Notes (Tables) | 9 Months Ended | ||||||||
Sep. 30, 2014 | |||||||||
Schedule of Total Interest Expense Included in Other Income (Expense), Net on Consolidated Statements of Operations and Comprehensive Loss Recognized Related to Notes | ' | ||||||||
The following table sets forth total interest expense, included in other income (expense), net on the Consolidated Statements of Operations and Comprehensive Loss, recognized related to the Notes during the three and nine months ended September 30, 2014 (in thousands): | |||||||||
Three Months Ended | Nine Months Ended | ||||||||
September 30, 2014 | September 30, 2014 | ||||||||
Contractual interest expense | $ | 439 | $ | 439 | |||||
Amortization of debt issuance costs | 72 | 72 | |||||||
Total interest expense | $ | 511 | $ | 511 | |||||
Stockholders_Equity_Tables
Stockholders' Equity (Tables) | 9 Months Ended | ||||||||
Sep. 30, 2014 | |||||||||
Component of Other Comprehensive Income (Loss) | ' | ||||||||
The accumulated balances related to each component of other comprehensive income (loss) are summarized as follows (in thousands): | |||||||||
Foreign | Total | ||||||||
Currency | Accumulated | ||||||||
Translation | Other | ||||||||
Adjustments | Comprehensive | ||||||||
Income (Loss) | |||||||||
Balance December 31, 2013 | $ | 4,696 | $ | 4,696 | |||||
Period change | (21,002 | ) | (21,002 | ) | |||||
Balance September 30, 2014 | $ | (16,306 | ) | $ | (16,306 | ) | |||
Balance December 31, 2012 | $ | 53 | $ | 53 | |||||
Period change | 4,643 | 4,643 | |||||||
Balance December 31, 2013 | $ | 4,696 | $ | 4,696 | |||||
ShareBased_Compensation_Tables
Share-Based Compensation (Tables) | 9 Months Ended | ||||||||||||||||
Sep. 30, 2014 | |||||||||||||||||
Share-Based Compensation Expense Recognized in Accompanying Statements of Operations | ' | ||||||||||||||||
Share-based compensation expense for all equity based programs, including stock options and the employee stock purchase plan, for the three and nine months ended September 30, 2014 and 2013, respectively, was recognized in the accompanying Consolidated Statements of Operations and Comprehensive Loss as follows: | |||||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
Research and development | $ | 2,991 | $ | 1,138 | $ | 8,005 | $ | 3,095 | |||||||||
General and administrative | 2,445 | 1,653 | 7,580 | 3,568 | |||||||||||||
Total share-based compensation expense | $ | 5,436 | $ | 2,791 | $ | 15,585 | $ | 6,663 | |||||||||
Summary of Stock Options Activity | ' | ||||||||||||||||
The following table summarizes the activity relating to the Company’s options to purchase common stock for the nine month period ended September 30, 2014: | |||||||||||||||||
Number of | Weighted- | Weighted- | Aggregate | ||||||||||||||
Options | Average | Average | Intrinsic | ||||||||||||||
Exercise | Remaining | Value | |||||||||||||||
Price | Contractual | ||||||||||||||||
Term (Years) | |||||||||||||||||
Outstanding at December 31, 2013 | 2,520,170 | $ | 21.19 | ||||||||||||||
Granted | 1,449,457 | 62 | |||||||||||||||
Exercised | (60,449 | ) | 8.96 | ||||||||||||||
Forfeited | (23,813 | ) | 34.96 | ||||||||||||||
Outstanding at September 30, 2014 | 3,885,365 | $ | 36.52 | 8.29 | $ | 64,790,012 | |||||||||||
Vested and expected to vest at September 30, 2014 | 3,620,712 | $ | 35.23 | 8.22 | $ | 63,341,213 | |||||||||||
Vested at September 30, 2014 | 1,503,631 | $ | 19.47 | 7.3 | $ | 41,643,182 | |||||||||||
Schedule of Share-Based Compensation Arrangements by Share-Based Payment Award | ' | ||||||||||||||||
Presented in the table below are financial details associated with our stock options during the three and nine months ended September 30, 2014 and 2013: | |||||||||||||||||
Three Months Ended September 30, | |||||||||||||||||
2014 | 2013 | ||||||||||||||||
Weighted-average grant-date fair value per share | $ | 27.85 | $ | 43.43 | |||||||||||||
Intrinsic value of options exercised | $ | 4,391 | $ | 85,589 | |||||||||||||
Cash received from stock option exercises | $ | 341 | $ | 34,711 | |||||||||||||
Nine Months Ended September 30, | |||||||||||||||||
2014 | 2013 | ||||||||||||||||
Weighted-average grant-date fair value per share | $ | 39.13 | $ | 18.43 | |||||||||||||
Intrinsic value of options exercised | $ | 2,754,669 | $ | 5,801,963 | |||||||||||||
Cash received from stock option exercises | $ | 541,508 | $ | 1,223,023 |
Nature_of_Business_and_Basis_o2
Nature of Business and Basis of Presentation - Additional Information (Detail) (USD $) | 9 Months Ended | 3 Months Ended |
In Thousands, unless otherwise specified | Sep. 30, 2014 | Mar. 31, 2014 |
Les Laboratoires Servier | ||
Nature Of Business [Line Items] | ' | ' |
License and milestone revenue | $13,625 | $13,600 |
EOS_Acquisition_Additional_Inf
EOS Acquisition - Additional Information (Detail) | Sep. 30, 2014 | Dec. 31, 2013 | Nov. 19, 2013 | Sep. 30, 2014 | Dec. 31, 2013 | Nov. 19, 2013 | Nov. 19, 2013 | Nov. 19, 2013 |
USD ($) | USD ($) | Ethical Oncology Science, S.p.A. | Ethical Oncology Science, S.p.A. | Ethical Oncology Science, S.p.A. | Ethical Oncology Science, S.p.A. | Ethical Oncology Science, S.p.A. | Ethical Oncology Science, S.p.A. | |
USD ($) | USD ($) | USD ($) | Regulatory and Sales Milestones | Regulatory and Sales Milestones | Regulatory and Sales Milestones | |||
Maximum | Maximum | Minimum | ||||||
USD ($) | EUR (€) | USD ($) | ||||||
Business Acquisition [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' |
Business acquisition cash payments made on acquisition | ' | ' | $11,800,000 | ' | ' | ' | ' | ' |
Business acquisition, common stock issued at acquisition date | ' | ' | 173,700,000 | ' | ' | ' | ' | ' |
Future potential cash consideration payments | ' | ' | ' | ' | ' | 65,000,000 | 115,000,000 | 0 |
Fair value of contingent consideration | $55,445,000 | $55,754,000 | ' | $55,400,000 | $55,800,000 | ' | ' | ' |
Assets_and_Liabilities_Measure
Assets and Liabilities Measured at Fair Value on Recurring Basis (Detail) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ' | ' |
Assets at fair value | $447,986 | $318,886 |
Contingent purchase consideration | 55,445 | 55,754 |
Liabilities at fair value | 55,445 | 55,754 |
Money Market | ' | ' |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ' | ' |
Assets at fair value | 447,986 | 318,886 |
Fair Value, Inputs, Level 1 | ' | ' |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ' | ' |
Assets at fair value | 447,986 | 318,886 |
Fair Value, Inputs, Level 1 | Money Market | ' | ' |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ' | ' |
Assets at fair value | 447,986 | 318,886 |
Fair Value, Inputs, Level 3 | ' | ' |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ' | ' |
Contingent purchase consideration | 55,445 | 55,754 |
Liabilities at fair value | $55,445 | $55,754 |
Fair_Value_Measurements_Additi
Fair Value Measurements - Additional Information (Detail) (USD $) | Sep. 30, 2014 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ' |
Transfers between Level 1 and Level 2 | $0 |
Rollforward_of_Fair_Value_of_L
Roll-forward of Fair Value of Level 3 Instruments (significant unobservable inputs) (Detail) (Fair Value, Inputs, Level 3, USD $) | 9 Months Ended |
In Thousands, unless otherwise specified | Sep. 30, 2014 |
Fair Value, Inputs, Level 3 | ' |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ' |
Balance at beginning of period | $55,754 |
Accretion | 2,571 |
Change in foreign currency gains and losses | -2,880 |
Balance at end of period | $55,445 |
Other_Current_Assets_Detail
Other Current Assets (Detail) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Other Current Assets [Line Items] | ' | ' |
Receivable from partners | $6,544 | $2,921 |
VAT recoverable | 45 | 950 |
Prepaid expenses and other | 1,336 | 521 |
Other current assets | $7,925 | $4,392 |
Intangible_Assets_and_Goodwill1
Intangible Assets and Goodwill - Additional Information (Detail) (USD $) | 9 Months Ended | |
Sep. 30, 2014 | Dec. 31, 2013 | |
Intangible Assets And Goodwill [Line Items] | ' | ' |
Intangible assets | $220,723,000 | $244,518,000 |
Decrease in intangible assets due to changes in foreign currency translation rates | -20,400,000 | ' |
Impairment charges for intangible assets | 3,409,000 | ' |
Goodwill | 68,482,000 | 74,811,000 |
In Process Research and Development | ' | ' |
Intangible Assets And Goodwill [Line Items] | ' | ' |
Intangible assets | 220,700,000 | 244,500,000 |
Ethical Oncology Science, S.p.A. | ' | ' |
Intangible Assets And Goodwill [Line Items] | ' | ' |
Goodwill | $68,500,000 | $74,800,000 |
Other_Accrued_Expenses_Detail
Other Accrued Expenses (Detail) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Accrued Liabilities [Line Items] | ' | ' |
Accrued personnel costs | $3,404 | $3,356 |
Accrued corporate legal fees and professional services | 132 | 257 |
Accrued expenses - other | 1,183 | 371 |
Other accrued expenses | $4,719 | $3,984 |
Convertible_Senior_Notes_Addit
Convertible Senior Notes - Additional Information (Detail) (USD $) | 0 Months Ended | 9 Months Ended | |
Sep. 09, 2014 | Sep. 30, 2014 | Sep. 09, 2014 | |
D | D | ||
Debt Instrument [Line Items] | ' | ' | ' |
Convertible senior notes, aggregate principal amount | ' | $287,500,000 | ' |
Net proceeds form convertible senior notes | ' | 287,500,000 | ' |
Convertible Senior Unsecured Notes | ' | ' | ' |
Debt Instrument [Line Items] | ' | ' | ' |
Convertible senior notes, aggregate principal amount | ' | ' | 287,500,000 |
Convertible senior notes, interest rate | ' | ' | 2.50% |
Net proceeds form convertible senior notes | 278,300,000 | ' | ' |
Convertible senior notes, frequency of periodic payment | ' | 'Semi-annually | ' |
Debt instrument, beginning date of periodic payment | ' | 15-Mar-15 | ' |
Convertible senior notes, maturity date | ' | 15-Sep-21 | ' |
Convertible senior notes, initial conversion price per share | ' | ' | $61.88 |
Common stock initial conversion rate per $1,000 in principal amount | 16.1616 | ' | ' |
Last reported sale price of common stock | 150.00% | ' | ' |
Debt instrument, conversion in effect for number of trading days | 20 | ' | ' |
Debt instrument conversion, consecutive trading day period | '30 days | ' | ' |
Debt instrument redemption price percentage to principal amount | 100.00% | ' | ' |
Debt instrument redemption description | ' | 'On or after September 15, 2018, we may redeem the Notes, at our option, in whole or in part, if the last reported sale price of our common stock has been at least 150% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period ending not more than two trading days preceding the date on which we provide written notice of redemption at a redemption price equal to 100% of the principal amount of the Notes to be redeemed plus accrued and unpaid interest to, but excluding, the redemption date. | ' |
Debt instrument, redemption period start date | ' | 15-Sep-18 | ' |
Debt instrument, trading days preceding redemption notice, maximum | ' | 2 | ' |
Debt instrument repurchase percentage | ' | 100.00% | ' |
Debt issuance costs | ' | 9,200,000 | ' |
Debt instrument term | ' | '7 years | ' |
Unamortized debt issuance costs | ' | 9,100,000 | ' |
Convertible Senior Unsecured Notes | Semi Annual Payment, First payment date | ' | ' | ' |
Debt Instrument [Line Items] | ' | ' | ' |
Interest payment date on senior notes | ' | '--03-15 | ' |
Convertible Senior Unsecured Notes | Semi Annual Payment, Second payment date | ' | ' | ' |
Debt Instrument [Line Items] | ' | ' | ' |
Interest payment date on senior notes | ' | '--09-15 | ' |
Convertible Senior Unsecured Notes | Fair Value, Inputs, Level 2 | ' | ' | ' |
Debt Instrument [Line Items] | ' | ' | ' |
Debt instrument, fair value | ' | $297,300,000 | ' |
Schedule_of_Total_Interest_Exp
Schedule of Total Interest Expense Included in Other Income (Expense), Net on Consolidated Statements of Operations and Comprehensive Loss Recognized Related to Notes (Detail) (USD $) | 3 Months Ended | 9 Months Ended |
In Thousands, unless otherwise specified | Sep. 30, 2014 | Sep. 30, 2014 |
Debt Instrument [Line Items] | ' | ' |
Contractual interest expense | $439 | $439 |
Amortization of debt issuance costs | 72 | 72 |
Total interest expense | $511 | $511 |
Stockholders_Equity_Additional
Stockholders' Equity - Additional Information (Detail) (USD $) | 9 Months Ended | 1 Months Ended | |
In Thousands, except Share data, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2014 | Jun. 30, 2013 |
Common Stock | |||
Class of Stock [Line Items] | ' | ' | ' |
Common stock, shares issued | ' | ' | 3,819,444 |
Sale of stock price per share | ' | $45.36 | $72 |
Proceeds from the sale of common stock, net of issuance costs | $259,071 | ' | $259,100 |
Component_of_Other_Comprehensi
Component of Other Comprehensive Income (Loss) (Detail) (USD $) | 9 Months Ended | 12 Months Ended |
In Thousands, unless otherwise specified | Sep. 30, 2014 | Dec. 31, 2013 |
Accumulated Other Comprehensive Income (Loss) [Line Items] | ' | ' |
Beginning balance | $4,696 | $53 |
Period change | -21,002 | 4,643 |
Ending balance | -16,306 | 4,696 |
Foreign Currency Translation Adjustments | ' | ' |
Accumulated Other Comprehensive Income (Loss) [Line Items] | ' | ' |
Beginning balance | 4,696 | 53 |
Period change | -21,002 | 4,643 |
Ending balance | ($16,306) | $4,696 |
ShareBased_Compensation_Expens
Share-Based Compensation Expense Recognized in Accompanying Statements of Operations (Detail) (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, unless otherwise specified | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' | ' |
Share-based compensation expense | $5,436 | $2,791 | $15,585 | $6,663 |
Research and development | ' | ' | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' | ' |
Share-based compensation expense | 2,991 | 1,138 | 8,005 | 3,095 |
General and administrative | ' | ' | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' | ' |
Share-based compensation expense | $2,445 | $1,653 | $7,580 | $3,568 |
ShareBased_Compensation_Additi
Share-Based Compensation - Additional Information (Detail) (USD $) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Dec. 31, 2013 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' | ' | ' |
Share-based compensation expense, tax benefit recognized | $0 | $0 | $0 | $0 | ' |
Capitalized share-based compensation expense | ' | ' | 0 | ' | 0 |
Closing stock price | $45.36 | ' | $45.36 | ' | ' |
Unrecognized stock-based compensation expense related to nonvested options | $51,600,000 | ' | $51,600,000 | ' | ' |
Unrecognized stock-based compensation expense related to nonvested options, weighted-average remaining vesting period | ' | ' | '3 years | ' | ' |
Summary_of_Stock_Options_Activ
Summary of Stock Options Activity (Detail) (USD $) | 9 Months Ended |
Sep. 30, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' |
Beginning Balance, Number of Options Outstanding | 2,520,170 |
Granted, Number of Options Outstanding | 1,449,457 |
Exercised, Number of Options Outstanding | -60,449 |
Forfeited, Number of Options Outstanding | -23,813 |
Ending Balance, Number of Options Outstanding | 3,885,365 |
Vested and expected to vest, Number of Options Outstanding | 3,620,712 |
Vested, Number of Options Outstanding | 1,503,631 |
Beginning Balance, Weighted Average Exercise Price | $21.19 |
Granted, Weighted Average Exercise Price | $62 |
Exercised, Weighted Average Exercise Price | $8.96 |
Forfeited, Weighted Average Exercise Price | $34.96 |
Ending Balance, Weighted Average Exercise Price | $36.52 |
Vested and expected to vest, Weighted Average Exercise Price | $35.23 |
Vested, Weighted Average Exercise Price | $19.47 |
Outstanding, Weighted Average Remaining Contractual Term (Years) | '8 years 3 months 15 days |
Vested and expected to vest, Weighted Average Remaining Contractual Term (Years) | '8 years 2 months 19 days |
Vested, Weighted Average Remaining Contractual Term (Years) | '7 years 3 months 18 days |
Outstanding, Aggregate Intrinsic Value | $64,790,012 |
Vested and expected to vest, Aggregate Intrinsic Value | 63,341,213 |
Vested, Aggregate Intrinsic Value | $41,643,182 |
Schedule_of_ShareBased_Compens
Schedule of Share-Based Compensation Arrangements by Share-Based Payment Award (Detail) (USD $) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' | ' |
Weighted-average grant-date fair value per share | $27.85 | $43.43 | $39.13 | $18.43 |
Intrinsic value of options exercised | $4,391 | $85,589 | $2,754,669 | $5,801,963 |
Cash received from stock option exercises | $341 | $34,711 | $541,508 | $1,223,023 |
License_Agreements_Additional_
License Agreements - Additional Information (Detail) | 9 Months Ended | 1 Months Ended | 3 Months Ended | 9 Months Ended | 1 Months Ended | 9 Months Ended | 1 Months Ended | 3 Months Ended | 1 Months Ended | ||||||||||
Sep. 30, 2014 | Sep. 30, 2013 | Dec. 31, 2013 | Sep. 30, 2012 | Sep. 30, 2014 | Mar. 31, 2014 | Sep. 30, 2014 | Dec. 31, 2013 | Feb. 28, 2014 | Apr. 30, 2014 | Sep. 30, 2014 | Apr. 30, 2012 | Oct. 31, 2008 | Mar. 31, 2014 | 31-May-10 | Jan. 31, 2013 | Jun. 30, 2011 | Apr. 30, 2012 | Feb. 28, 2014 | |
USD ($) | USD ($) | USD ($) | Les Laboratoires Servier | Les Laboratoires Servier | Les Laboratoires Servier | Les Laboratoires Servier | Les Laboratoires Servier | License Agreement Terms | License Agreement Terms | License Agreement Terms | License Agreement Terms | License Agreement Terms | License Agreement Terms | Up-front license payment | Up-front license payment | Up-front license payment | Up-front license payment | Regulatory Milestone Payment | |
EUR (€) | USD ($) | USD ($) | USD ($) | USD ($) | License Agreements Licensor Avila Therapeutics | License Agreements Licensor Pfizer | License Agreements Licensor Pfizer | License Agreements Licensor Astra Zeneca U K Ltd | Advenchen Laboratories LLC | Advenchen Laboratories LLC | License Agreement Terms | License Agreement Terms | License Agreement Terms | License Agreement Terms | License Agreement Terms | ||||
Name of drug product in-licensed by the entity - Rociletinib | Rucaparib | Rucaparib | Rucaparib | USD ($) | License Agreements Licensor Avila Therapeutics | License Agreements Licensor Gatekeeper | License Agreements Licensor Pfizer | License Agreements Licensor Astra Zeneca U K Ltd | License Agreements Licensor Avila Therapeutics | ||||||||||
USD ($) | USD ($) | USD ($) | USD ($) | Name of drug product in-licensed by the entity - Rociletinib | Name of drug product in-licensed by the entity - Rociletinib | Rucaparib | Rucaparib | Name of drug product in-licensed by the entity - Rociletinib | |||||||||||
USD ($) | USD ($) | USD ($) | USD ($) | USD ($) | |||||||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Up-front payment | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $2,000,000 | $250,000 | $7,000,000 | $250,000 | ' |
Acquired in process research and development costs | 8,806,000 | 250,000 | ' | ' | ' | ' | ' | ' | ' | 400,000 | ' | ' | ' | 3,400,000 | ' | ' | ' | ' | 5,000,000 |
Future expected development and regulatory payment | ' | ' | ' | ' | ' | ' | ' | ' | 110,000,000 | ' | ' | 700,000 | ' | ' | ' | ' | ' | ' | ' |
Sales milestone payments | ' | ' | ' | ' | ' | ' | ' | ' | 120,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Future expected development, regulatory and sales milestone payments | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 258,500,000 | ' | ' | ' | ' | ' | ' | ' | ' |
Percentage of Non-Royalty Consideration Payable on Sublicense Agreements | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 25.00% | ' | ' | ' | ' | ' | ' |
Sublicense agreement consideration | 13,625,000 | ' | ' | ' | ' | 13,600,000 | ' | ' | ' | ' | ' | ' | ' | 13,600,000 | ' | ' | ' | ' | ' |
Additional payments receivable on achievement | ' | ' | ' | 90,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Additional payments receivable on attaining the sales target | ' | ' | ' | 250,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Initial global development costs reimbursable | ' | ' | ' | 80,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Development cost receivable | 6,544,000 | ' | 2,921,000 | ' | 6,500,000 | ' | 6,500,000 | 2,900,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Reduction in research and development expense for reimbursable development costs due from Servier | ' | ' | ' | ' | $4,100,000 | ' | $7,900,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Income_Taxes_Additional_Inform
Income Taxes - Additional Information (Detail) (USD $) | 3 Months Ended | 9 Months Ended |
In Thousands, unless otherwise specified | Sep. 30, 2014 | Sep. 30, 2014 |
Income Taxes [Line Items] | ' | ' |
Income tax expense | $292 | $2,489 |
Commitments_and_Contingencies_
Commitments and Contingencies - Additional Information (Detail) (USD $) | 1 Months Ended | |
Feb. 28, 2013 | Sep. 30, 2014 | |
Purchase Commitment, Excluding Long-term Commitment [Line Items] | ' | ' |
Purchase commitment | ' | $0 |
Contractual agreement quarterly forecasts required period | '24 months | ' |
Contractual agreement obligated forecast period | '12 months | ' |