Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2015 | Oct. 31, 2015 | |
Document and Entity Information | ||
Entity Registrant Name | GENOMIC HEALTH INC | |
Entity Central Index Key | 1,131,324 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2015 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 32,542,356 | |
Document Fiscal Year Focus | 2,015 | |
Document Fiscal Period Focus | Q3 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
Current assets: | ||
Cash and cash equivalents | $ 28,010 | $ 29,726 |
Short-term marketable securities (see Note 3) | 70,003 | 73,934 |
Accounts receivable (net of allowance for doubtful accounts; 2015 - $3,926, 2014 - $3,628) | 33,754 | 34,916 |
Prepaid expenses and other current assets | 10,238 | 9,944 |
Total current assets | 142,005 | 148,520 |
Property and equipment, net | 34,682 | 21,860 |
Other assets | 1,656 | 15,541 |
Total assets | 178,343 | 185,921 |
Current liabilities: | ||
Accounts payable | 5,595 | 6,987 |
Accrued compensation and employee benefits | 20,804 | 17,708 |
Accrued license fees | 2,197 | 2,656 |
Accrued expenses and other current liabilities | 14,465 | 10,444 |
Deferred revenues | 251 | 335 |
Other current liabilities | 208 | 208 |
Total current liabilities | 43,520 | 38,338 |
Other liabilities | $ 2,294 | $ 2,070 |
Commitments (see Note 5) | ||
Stockholders' equity: | ||
Common stock | $ 3 | $ 3 |
Additional paid- in capital | 386,738 | 370,496 |
Accumulated other comprehensive income (loss) | 1,332 | (15) |
Accumulated deficit | (225,434) | (194,861) |
Treasury stock, at cost | 30,110 | 30,110 |
Total stockholders' equity | 132,529 | 145,513 |
Total liabilities and stockholders' equity | $ 178,343 | $ 185,921 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
Condensed Consolidated Balance Sheets | ||
Accounts receivable, allowance for doubtful accounts | $ 3,926 | $ 3,628 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) shares in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Revenues: | ||||
Product revenues | $ 73,554,000 | $ 69,101,000 | $ 212,325,000 | $ 206,580,000 |
Operating expenses: | ||||
Cost of product revenues | 13,718,000 | 11,979,000 | 39,513,000 | 36,241,000 |
Research and development | 13,480,000 | 13,891,000 | 47,193,000 | 40,527,000 |
Selling and marketing | 35,369,000 | 34,059,000 | 107,964,000 | 102,702,000 |
General and administrative | 16,425,000 | 15,007,000 | 48,594,000 | 44,750,000 |
Total operating expenses | 78,992,000 | 74,936,000 | 243,264,000 | 224,220,000 |
Loss from operations | (5,438,000) | (5,835,000) | (30,939,000) | (17,640,000) |
Interest income | 54,000 | 47,000 | 163,000 | 144,000 |
Other income (expense), net | (158,000) | (345,000) | (207,000) | (537,000) |
Loss before income taxes | (5,542,000) | (6,133,000) | (30,983,000) | (18,033,000) |
Income tax (benefit) expense | 6,301,000 | 129,000 | (410,000) | 292,000 |
Net loss | $ (11,843,000) | $ (6,262,000) | $ (30,573,000) | $ (18,325,000) |
Basic and diluted net loss per share (in dollars per share) | $ (0.36) | $ (0.20) | $ (0.95) | $ (0.58) |
Shares used in computing basic and diluted net loss per share | 32,498 | 31,590 | 32,294 | 31,339 |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Comprehensive Income (Loss) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Condensed Consolidated Statements of Comprehensive Income (Loss) | ||||
Net loss | $ (11,843) | $ (6,262) | $ (30,573) | $ (18,325) |
Other comprehensive income (loss): | ||||
Unrealized gain (loss) on available-for-sale marketable securities, net of tax expense (benefit) of $6,206 and $(765) for the three and nine months ended September 30, 2015, respectively, and $0 for the three and nine months ended September 30, 2014 | (10,696) | (5) | 1,347 | (14) |
Comprehensive loss | $ (22,539) | $ (6,267) | $ (29,226) | $ (18,339) |
Condensed Consolidated Stateme6
Condensed Consolidated Statements of Comprehensive Income (Loss) (Parenthtical) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Condensed Consolidated Statements of Comprehensive Income (Loss) | ||||
Unrealized gain (loss) on available-for-sale marketable securities, tax expense (benefit) | $ 6,206 | $ 0 | $ (765) | $ 0 |
Condensed Consolidated Stateme7
Condensed Consolidated Statements of Cash Flows - USD ($) | 9 Months Ended | |
Sep. 30, 2015 | Sep. 30, 2014 | |
Operating activities | ||
Net loss | $ (30,573,000) | $ (18,325,000) |
Adjustments to reconcile net loss to net cash (used in) provided by operating activities: | ||
Depreciation and amortization | 5,076,000 | 5,197,000 |
Employee stock-based compensation | 12,055,000 | 12,596,000 |
Write-off of previously capitalized software costs | 635,000 | |
Impairment of assets held for sale and other long-lived assets | 414,000 | |
Outside director restricted stock awarded in lieu of fees | 150,000 | 170,000 |
Gain on disposal of property and equipment | (61,000) | (72,000) |
Deferred tax benefit from unrealized gain on available-for-sale marketable securities | (765,000) | |
Changes in assets and liabilities: | ||
Accounts receivable | 1,162,000 | (1,521,000) |
Prepaid expenses and other assets | (383,000) | 242,000 |
Accounts payable | (1,816,000) | 672,000 |
Accrued compensation and employee benefits | 3,096,000 | 650,000 |
Accrued expenses and other liabilities | 1,863,000 | 2,979,000 |
Deferred revenues | (84,000) | (397,000) |
Net cash (used in) provided by operating activities | (9,645,000) | 2,605,000 |
Investing activities | ||
Purchases of property and equipment | (16,056,000) | (5,588,000) |
Proceeds from sale of property and equipment | 42,000 | 117,000 |
Purchases of marketable securities | (54,605,000) | (72,221,000) |
Maturities of marketable securities | 74,505,000 | 76,826,000 |
Purchase of other investments | (2,000,000) | |
Net cash provided by (used in) investing activities | 3,886,000 | (2,866,000) |
Financing activities | ||
Net proceeds from issuance of common stock under stock plans | 7,766,000 | 7,703,000 |
Withholding taxes related to restricted stock units net share settlement | (3,723,000) | (3,483,000) |
Net cash provided by financing activities | 4,043,000 | 4,220,000 |
Net (decrease) increase in cash and cash equivalents | (1,716,000) | 3,959,000 |
Cash and cash equivalents at the beginning of the period | 29,726,000 | 33,279,000 |
Cash and cash equivalents at the end of the period | 28,010,000 | 37,238,000 |
Non-cash investing and financing activities | ||
Accrued purchase of property and equipment | 4,128,000 | $ 874,000 |
Change in fair value of equity investment | $ 2,083,000 |
Organization and Summary of Sig
Organization and Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2015 | |
Organization and Summary of Significant Accounting Policies | |
Organization and Summary of Significant Accounting Policies | Note 1. Organization and Summary of Significant Accounting Policies The Company Genomic Health, Inc. (the “Company”) is a global healthcare company that provides clinically-actionable genomic information to personalize cancer treatment. The Company develops and globally commercializes genomic ‑based clinical laboratory services that analyze the underlying biology of cancer, allowing physicians and patients to make individualized treatment decisions. The Company is translating significant amounts of genomic data that will be useful for treatment planning throughout the cancer patient’s journey, from diagnosis to treatment selection and monitoring. The Company was incorporated in Delaware in August 2000. The Company’s first product, the Onco type DX invasive breast cancer test, was launched in 2004 and is used for early stage invasive breast cancer patients to predict the likelihood of breast cancer recurrence and the likelihood of chemotherapy benefit. In January 2010, the Company launched its second product, the Onco type DX colon cancer test, which is used to predict the likelihood of colon cancer recurrence in patients with stage II disease. In December 2011, the Company made Onco type DX available for patients with ductal carcinoma in situ (“DCIS”), a pre ‑invasive form of breast cancer. This test provides a DCIS score that is used to predict the likelihood of local recurrence. In June 2012, the Company began offering the Onco type DX colon cancer test for use in patients with stage III disease treated with oxaliplatin ‑containing adjuvant therapy. In May 2013, the Company launched the Onco type DX prostate cancer test. The test provides a Genomic Prostate Score, or GPS, to predict disease aggressiveness in men with low risk disease. This test is used to improve treatment decisions for prostate cancer patients, in conjunction with the Gleason score, or tumor grading. Principles of Consolidation The accompanying condensed consolidated financial statements include all the accounts of the Company and its wholly-owned subsidiaries. The Company had two wholly-owned subsidiaries at September 30, 2015: Genomic Health International Holdings, LLC, which was established in Delaware in 2010 and supports the Company’s international sales and marketing efforts; and Oncotype Laboratories, Inc., which was established in 2012, and is inactive. Genomic Health International Holdings, LLC has 10 wholly-owned subsidiaries. The functional currency for the Company’s wholly-owned subsidiaries incorporated outside the United States is the U.S. dollar. All significant intercompany balances and transactions have been eliminated. Basis of Presentation and Use of Estimates The accompanying interim period condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”). The condensed consolidated balance sheet as of September 30, 2015, condensed consolidated statements of operations and comprehensive income (loss) for the three and nine months ended September 30, 2015 and 2014, and condensed consolidated statements of cash flows for the nine months ended September 30, 2015 and 2014 are unaudited, but include all adjustments, consisting only of normal recurring adjustments, which the Company considers necessary for a fair presentation of its financial position, operating results and cash flows for the periods presented. The condensed consolidated balance sheet at December 31, 2014 has been derived from audited financial statements, but it does not include certain information and notes required by GAAP for complete consolidated financial statements. The preparation of financial statements in conformity with GAAP requires management to make judgments, assumptions and estimates that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosures in the Company’s condensed consolidated financial statements and accompanying notes. Actual results could differ materially from those estimates. The accompanying interim period condensed consolidated financial statements and related financial information should be read in conjunction with the audited consolidated financial statements and the related notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2014. Certain reclassifications have been made to prior period amounts to conform to the current period presentation. For the three and nine months ended September 30, 2014, a reclassification of certain expenses from research and development to selling and marketing was made in the condensed consolidated statements of operations to conform to the current period presentation. Revenue Recognition The Company derives its revenues from product sales. The majority of the Company’s historical product revenues have been derived from the sale of the Onco type DX breast cancer test. The Company generally bills third ‑party payors upon generation and delivery of a patient report to the physician. As such, the Company takes assignment of benefits and the risk of collection with the third ‑party payor. The Company generally bills the patient directly for amounts owed after multiple requests for payment have been denied or only partially paid by the insurance carrier. The Company pursues case ‑by ‑case reimbursement where medical policies are not in place or payment history has not been established. The Company’s product revenues for tests performed are recognized when the following revenue recognition criteria are met: (1) persuasive evidence that an arrangement exists; (2) delivery has occurred or services have been rendered; (3) the fee is fixed or determinable; and (4) collectability is reasonably assured. Criterion (1) is satisfied when the Company has an arrangement to pay or a contract with the payor in place addressing reimbursement for the Onco type DX test. In the absence of such arrangements, the Company considers that criterion (1) is satisfied when a third ‑party payor pays the Company for the test performed. Criterion (2) is satisfied when the Company performs the test and generates and delivers to the physician, or makes available on its web portal, a patient report. When evaluating whether the fee is fixed or determinable and collectible, the Company considers whether it has sufficient history to reliably estimate the total fee that will be received from a payor and a payor’s individual payment patterns. Determination of criteria (3) and (4) are based on management’s judgments regarding whether the fee charged for products or services delivered is fixed or determinable, and the collectability of those fees under any contract or arrangement. Based upon at least several months of payment history, the Company reviews the number of tests paid against the number of tests billed and the payor’s outstanding balance for unpaid tests to determine whether payments are being made at a consistently high percentage of tests billed and at appropriate amounts given the arrangement or contracted payment amount. The estimated accrual amounts per test, recorded upon delivery of a patient report, are calculated for each accrual payor and are based on the arrangement or contracted price adjusted for individual payment patterns resulting from co-payment amounts and excluded services in healthcare plans. The Company also reduces sales for an estimate of amounts that qualify as patient assistance and related deductions that do not qualify for revenue recognition. When a payment received for an individual test is either higher or lower than the estimated accrual amount, the Company recognizes the difference as either cash revenue, in the case of higher payments, or in the case of lower payments, a charge against either the patient assistance program and related deductions reserve or the allowance for doubtful accounts, as applicable. To the extent all criteria set forth above are not met when test results are delivered, product revenues are recognized when cash is received from the payor. The Company has exclusive distribution agreements for one or more of its Onco type DX tests with distributors covering more than 90 countries. The distributor generally provides certain marketing and administrative services to the Company within its territory. As a condition of these agreements, the distributor generally pays the Company an agreed upon fee per test and the Company processes the tests. The same revenue recognition criteria described above generally apply to tests received through distributors. To the extent all criteria set forth above are not met when test results are delivered, product revenues are generally recognized when cash is received from the distributor. From time to time, the Company receives requests for refunds of payments, generally due to overpayments made by third-party payors. Upon becoming aware of a refund request, the Company establishes an accrued liability for tests covered by the refund request until such time as the Company determines whether or not a refund is due. Accrued refunds were $532,000 and $944,000 at September 30, 2015 and December 31, 2014, respectively, and are included in accrued expenses and other current liabilities. Advance payments received in excess of revenues recognized are classified as deferred revenue until such time as the revenue recognition criteria have been met. Allowance for Doubtful Accounts The Company accrues an allowance for doubtful accounts against its accounts receivable based on estimates consistent with historical payment experience. Bad debt expense is included in general and administrative expense on the Company’s condensed consolidated statements of operations. Accounts receivable are written off against the allowance when the appeals process is exhausted, when an unfavorable coverage decision is received or when there is other substantive evidence that the account will not be paid. The Company’s allowance for doubtful accounts as of September 30, 2015 and December 31, 2014 was $3.9 million and $ 3.6 million, respectively. Write-offs for doubtful accounts of $1.7 million and $4.0 million were recorded against the allowance during the three and nine months ended September 30, 2015, respectively, and write-offs of $1.0 million and $4.0 million were recorded against the allowance during the three and nine months ended September 30, 2014, respectively. Bad debt expense was $2.1 million and $4.7 million for the three and nine months ended September 30, 2015, respectively, and $1.7 million and $4.8 million for the three and nine months ended September 30, 2014, respectively. Investments in Equity Securities Beginning in 2011, the Company made investments in various tranches of the preferred stock of Invitae Corporation (“Invitae”), which at the time was a privately-held company, such that the carrying value of this investment was $13.9 million at December 31, 2014. On February 18, 2015, Invitae completed an initial public offering of its common stock and the Company’s preferred stock investment automatically converted into 2,207,793 shares of Invitae common stock. This investment is accounted for under the cost method as an available-for-sale marketable security and valued at $15.9 million at September 30, 2015. Unrealized gains or losses resulting from changes in the fair value of this investment will be recorded in other comprehensive income until the securities are sold. These securities were subject to a lock-up agreement that expired in August 2015 and continue to be subject to the resale limitations of Rule 144 under the Securities Act of 1933. Property and Equipment Property and equipment, including purchased and internally developed software are stated at cost. Depreciation is calculated using the straight ‑line method over the estimated useful lives of the assets, which generally range from three to seven years. Leasehold improvements are amortized using the straight ‑line method over the estimated useful lives of the assets or the remaining term of the lease, whichever is shorter. The Company wrote off $57,000 and $635,000 of previously capitalized software costs for the three and nine months ended September 30, 2015, respectively. Recently Issued Accounting Pronouncements In April 2015, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update No. 2015-05, Intangibles - Goodwill and Other - Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Fees Paid in a Cloud Computing Arrangement (“ASU 2015-05”). This amendment provides guidance to help entities determine whether a cloud computing arrangement contains a software license that should be accounted for as internal-use software or as a service contract. ASU 2015-05 is effective for interim and annual reporting periods beginning after December 15, 2015, with early adoption permitted. Upon adoption, an entity has the option to apply the provisions of ASU 2015-05 either prospectively to all arrangements entered into or materially modified, or retrospectively. The Company does not expect the impact of the adoption of ASU 2015-05 to be material to its consolidated financial statements. In May 2014, the FASB issued Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers (“ASU 2014-09”) to provide guidance on revenue recognition. ASU 2014-09 requires a company to recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. In doing so, companies will need to use more judgment and make more estimates than under current guidance. These may include identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each separate performance obligation. In July 2015, the FASB deferred the effective date for annual reporting periods beginning after December 15, 2017 (including interim reporting periods within those periods). Early adoption is permitted to the original effective date of December 15, 2016 (including interim reporting periods within those periods). The amendments may be applied retrospectively to each prior period presented or retrospectively with the cumulative effect recognized as of the date of initial application. The Company is currently evaluating the impact of adopting ASU 2014-09 on its consolidated financial statements. |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Sep. 30, 2015 | |
Net Loss Per Share | |
Net Loss Per Share | Note 2. Net Loss Per Share Basic net loss per share is calculated by dividing net loss for the period by the weighted-average number of common shares outstanding for the period without consideration of potential common shares. Diluted net loss per share is calculated by dividing net loss by the weighted-average number of common shares outstanding for the period and dilutive potential common shares for the period determined using the treasury-stock method. For purposes of this calculation, options to purchase common stock and restricted stock unit (“RSU”) awards are considered to be potential common shares and are not included in the calculation of diluted net loss per share because their effect is anti-dilutive. Options to purchase 671,000 and 853,000 shares of the Company’s common stock were outstanding during the three and nine months ended September 30, 2015, respectively, and 106,000 and 116,000 RSUs were outstanding during the three and nine months ended September 30, 2015, respectively, but were not included in the computation of diluted net loss per share because their effect is anti-dilutive. Options to purchase 1.0 million shares of the Company’s common stock were outstanding during the three and nine months ended September 30, 2014, respectively, and 139,000 and 109,000 RSUs were outstanding during the three and nine months ended September 30, 2014, respectively, but were not included in the computation of diluted net loss per share because their effect is anti-dilutive. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2015 | |
Fair Value Measurements | |
Fair Value Measurements | Note 3. Fair Value Measurements The Company measures certain financial assets, including cash equivalents and marketable securities, at their fair value on a recurring basis. The fair value of these financial assets was determined based on a hierarchy of three levels of inputs, of which the first two are considered observable and the last unobservable, as follows: Level 1: Quoted prices in active markets for identical assets or liabilities; Level 2: Observable inputs other than Level 1 inputs, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities; and Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability. The Company did not have any non-financial assets or liabilities that were measured or disclosed at fair value on a recurring basis at either September 30, 2015 or December 31, 2014, respectively. The following tables set forth the Company’s financial instruments that were measured at fair value on a recurring basis at September 30, 2015 and December 31, 2014 by level within the fair value hierarchy: Actively Quoted Significant Markets for Other Significant Identical Observable Unobservable Balance at Assets Inputs Inputs September 30, Level 1 Level 2 Level 3 2015 (In thousands) As of September 30, 2015: Assets Money market deposits $ $ — $ — $ Commercial paper — — Corporate debt securities — — Corporate equity securities — — Total $ $ $ — $ Actively Quoted Significant Markets for Other Significant Identical Observable Unobservable Balance at Assets Inputs Inputs December 31, Level 1 Level 2 Level 3 2014 (In thousands) As of December 31, 2014: Assets Money market deposits $ $ — $ — $ Commercial paper — — Corporate debt securities — — Total $ $ $ — $ The Company’s commercial paper and corporate bonds are classified as Level 2 as they are valued using multi-dimensional relational pricing models that use observable market inputs, including benchmark yields, reported trades, broker-dealer quotes, issuer spreads, benchmark securities, bids, offers and reference data. Not all inputs listed are available for use in the evaluation process on any given day for each security evaluation. In addition, market indicators and industry and economic events are monitored and may serve as a trigger to acquire further corroborating market data. The Company’s corporate equity securities are classified as Level 2 while subject to certain restrictions on sale. The Company’s corporate equity securities at September 30, 2015 were previously recorded as investments in a privately held company and included in other assets as of December 31, 2014. There were no transfers between Level 1 and Level 2 categories during the three or nine months ended September 30, 2015 and 2014 , respectively. All of the Company’s marketable securities are classified as available-for-sale. The following tables illustrate the Company’s available-for-sale marketable securities as of the dates indicated: September 30, 2015 Amortized Unrealized Unrealized Estimated Cost Gains Losses Fair Value (In thousands) Commercial paper $ $ $ — $ Corporate debt securities Corporate equity securities — Total $ $ $ $ December 31, 2014 Amortized Unrealized Unrealized Estimated Cost Gains Losses Fair Value (In thousands) Commercial paper $ $ $ — $ Corporate debt securities — Total $ $ $ $ The Company had no realized gains or losses on available-for-sale marketable securities for the three and nine months ended September 30, 2015 and 2014, respectively. All of the Company’s available-for-sale marketable securities had contractual maturities of one year or less as of September 30, 2015 and December 31, 2014. |
Collaboration and Commercial Te
Collaboration and Commercial Technology Licensing Agreements | 9 Months Ended |
Sep. 30, 2015 | |
Collaboration and Commercial Technology Licensing Agreements | |
Collaboration and Commercial Technology Licensing Agreements | Note 4. Collaboration and Commercial Technology Licensing Agreements The Company has entered into a variety of collaboration and specimen transfer agreements relating to its development efforts. The Company recorded collaboration expenses of $1.4 million and $10.8 million for the three and nine months ended September 30, 2015, respectively, and $1.9 million and $4.1 million for the three and nine months ended September 30, 2014, respectively, relating to services provided in connection with these agreements. The $10.8 million of collaboration expense for the nine months ended September 30, 2015 includes a one-time $5.5 million expense for the wind-down of a license agreement and development program as described below. In addition to these expenses, some of the agreements contain provisions for royalties from inventions resulting from the collaborations. The Company has specified options and rights relating to joint inventions arising out of the collaborations. The Company is a party to various agreements under which it licenses technology on a non-exclusive basis in the field of human diagnostics. Access to these licenses enables the Company to process its Onco type DX tests. While certain agreements contain provisions for fixed annual payments, license fees are generally calculated as a percentage of product revenues, with rates that vary by agreement and may be tiered, and payments that may be capped at annual minimum or maximum amounts. The Company recognized costs recorded under these agreements totaling $2.3 million and $6.9 million for the three and nine months ended September 30, 2015, respectively, and $2.4 million and $7.2 million for the three and nine months ended September 30, 2014, respectively, which were included in cost of product revenues. In November 2013, the Company entered into an exclusive license agreement to develop and commercialize a test to predict benefit from DNA damage-based chemotherapy drugs, such as anthracycline-based regimens, in high risk breast cancer. The Company made an up-front payment of $9.0 million, which was recognized in research and development expense in the fourth quarter of 2013, and milestone payments would have been required if certain clinical and commercial endpoints were achieved in the future. With successful commercialization of a test, the Company would have been obligated to pay royalties. During the quarter ended March 31, 2015, the Company accrued $5.5 million in anticipation of the wind-down of this license agreement and development program, which was recognized as research and development expense in the accompanying condensed consolidated statements of operations. The license agreement was terminated in May 2015 and, as a result, the Company has no future obligations under this agreement. The Company is required to make a series of fixed annual payments under a collaboration agreement beginning with the one year anniversary of achieving a key milestone for the Company’s DCIS clinical study in June 2014. As of September 30, 2015, future annual payments under this agreement totaled $1.7 million, including payments of $604,000 , $604,000 , and $504,000 due in 2015, 2016, and 2017, respectively. |
Commitments
Commitments | 9 Months Ended |
Sep. 30, 2015 | |
Commitments | |
Commitments | Note 5. Commitments Lease Obligations In September 2005, the Company entered into a non-cancelable lease for 48,000 square feet of laboratory and office space that the Company currently occupies in Redwood City, California. In November 2010, the Company executed an amendment to extend the term of the lease through March 2019, with an option for the Company to extend the term of the lease for an additional five years. The agreement included lease incentive obligations of $834,000 that are being amortized on a straight line basis over the life of the lease. In January 2007, the Company entered into a non-cancelable lease for an additional 48,000 square feet of laboratory and office space in a nearby location. In November 2010, the Company executed an amendment to extend the term of the lease through March 2018, with an option for the Company to extend the lease for an additional five years. The agreement included lease incentive obligations totaling $283,000 that are being amortized on a straight line basis over the life of the lease. In October 2009, the Company entered into a non-cancelable agreement to lease an additional 30,500 square feet of office space near the locations the Company occupies. The lease expires in March 2018, with an option for the Company to extend the term of the lease for an additional five years. The agreement includes lease incentive obligations of $307,000 that are being amortized on a straight line basis over the life of the lease. In August 2013, the Company entered into a non-cancelable agreement to lease an additional 18,400 square feet of laboratory and office space near the locations the Company currently occupies. The lease expires in March 2019, with an option for the Company to extend the term of the lease for an additional five years. In July 2014, the Company leased an additional 5,500 square feet in the same location on the same terms. The agreements include lease incentive obligations of $358,000 that are being amortized on a straight line basis over the life of the lease. In May 2010, the Company’s European subsidiary entered into a non-cancelable lease for approximately 2,500 square feet of office space in Geneva, Switzerland. In May 2014, the Company executed an amendment to extend the terms of the lease and executed a new lease for approximately 5,000 square feet of additional space in the same location. Both leases expire in May 2016. Future non-cancelable commitments under these operating leases at September 30, 2015 were as follows: Annual Payments (In thousands) Years Ending December 31, 2015 (remainder of year) $ 2016 2017 2018 2019 Total minimum payments $ |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2015 | |
Stock-Based Compensation | |
Stock-Based Compensation | Note 6. Stock-Based Compensation Stock Options The Company granted options to purchase 17,000 and 449,667 shares of common stock to employees during the three and nine months ended September 30, 2015, respectively, and options to purchase 442,010 shares of common stock to employees during nine months ended September 30, 2014. There were no options granted during the three months ended September 30, 2014. For the three and nine months ended September 30, 2015, the Company issued 69,123 and 335,192 shares of common stock in connection with the exercise of stock options with a weighted-average exercise price of $12.62 and $15.70 per share, respectively. For the three and nine months ended September 30, 2014, the Company issued 166,090 and 424,840 shares of common stock in connection with the exercise of stock options with a weighted-average exercise price of $15.47 and $12.85 per share, respectively. Performance-Based Vesting Stock Options During the nine months ended September 30, 2015, the Company granted performance-based vesting stock options (“PV stock options”) to purchase 148,100 shares of common stock. There were no PV stock options granted during the three months ended September 30, 2015 or the three and nine months ended September 30, 2014. The number of shares potentially issuable under PV stock options is subject to the attainment of pre-established, objective performance goals over a specified period. In addition, the awards have a service vesting criteria following the achievement of performance criteria through February 2019. The Company recognizes the fair value of these awards to the extent the achievement of the related performance criteria is estimated to be probable. If a performance criterion is subsequently determined to not be probable of achievement, any related expense is reversed in the period such determination is made. Conversely, if a performance criterion is not currently expected to be achieved but is later determined to be probable of achievement, a “catch-up” entry is recorded in the period such determination is made for the expense that would have been recognized had the performance criterion been probable of achievement since the grant of the award. As of September 30, 2015, the achievement of the performance criteria was not estimated to be probable. Changes in the Company’s assessment of the probability of achievement of performance criteria could result in expense being accrued or reversed in future periods. Restricted Stock Units During the three and nine months ended September 30, 2015, the Company awarded 19,319 and 403,825 RSUs with a grant-date fair value of $530,000 and $12.5 million, or $27.46 and $30.85 per share, respectively. During the three and nine months ended September 30, 2014, the Company awarded 21,970 and 367,157 RSUs with a grant-date fair value of $607,000 and $10.7 million , or $27.64 and $29.07 per share, respectively. Each RSU entitles the recipient to receive one share of the Company’s common stock upon vesting. RSUs awarded to employees generally vest as to one -third of the total number of shares awarded annually over a three -year period. During the three and nine months ended September 30, 2015, the Company issued 9,780 and 174,997 shares of common stock in connection with the vesting of RSUs with a weighted-average grant date fair value of $31.72 and $29.79 per share, respectively. During the three and nine months ended September 30, 2014, the Company issued 9,901 and 182,574 shares of common stock in connection with the vesting of RSUs with a weighted-average grant date fair value of $30.69 and $28.30 per share, respectively. Performance-Based Vesting Restricted Stock Units During the nine months ended September 30, 2015, the Company awarded 22,980 performance-based vesting restricted stock units (“PVRSUs”) with a grant-date fair value of $715,000 , or $31.12 per share. The amount potentially available under a PVRSU is subject to the attainment of pre-established, objective performance goals over a specified period. In addition, the awards have a service vesting criteria following the achievement of performance criteria through February 2018. During the nine months ended September 30, 2014, the Company awarded 44,630 PVRSUs with a grant-date fair value of $1.2 million or $27.21 per share. In addition, these awards have a service vesting criteria following the achievement of performance criteria through February 2016. During the nine months ended September 30, 2015, the Company issued 4,227 shares of common stock in connection with the vesting of PVRSUs with a weighted-average grant date fair value of $27.21 per share. As of September 30, 2015, there were 29,133 PVRSUs outstanding with a grant date fair value of $883,000 . The Company recognizes the fair value of these awards to the extent the achievement of the related performance criteria is estimated to be probable. If a performance criterion is subsequently determined to not be probable of achievement, any related expense is reversed in the period such determination is made. Conversely, if a performance criterion is not currently expected to be achieved but is later determined to be probable of achievement, a “catch-up” entry is recorded in the period such determination is made for the expense that would have been recognized had the performance criterion been probable of achievement since the grant of the award. As of September 30, 2015, the achievement of the performance criteria was not estimated to be probable. Changes in the Company’s assessment of the probability of achievement of performance criteria could result in expense being accrued or reversed in future periods. Restricted Stock in Lieu of Directors’ Fees Outside members of the Company’s Board of Directors may elect to receive fully-vested restricted stock in lieu of cash compensation for services as a director. During the three and nine months ended September 30, 2015, the Company issued 1,825 and 5,025 shares of restricted stock to outside directors, with a grant date fair value of $50,000 and $150,000 , and a weighted-average grant date fair value of $27.34 and $29.79 per share, respectively. During the three and nine months ended September 30, 2014, the Company issued 2,148 and 6,109 shares of restricted stock to outside directors, with a grant date fair value of $60,000 and $170,000 , and a weighted-average grant date fair value of $27.86 and $27.78 per share, respectively. Employee Stock Purchase Plan During the nine months ended September 30, 2015, 108,674 shares of common stock were issued under the Company’s Employee Stock Purchase Plan (“ESPP”). There were no shares issued during the three months ended September 30, 2014. A total of 1,250,000 shares of common stock have been reserved for issuance under the ESPP, of which 651,064 shares were available for issuance as of September 30, 2015. As of September 30, 2015, there was $222,000 of unrecognized compensation expense related to the ESPP, which is expected to be recognized over a period of tw o months. Employee Stock-Based Compensation Expense The Company recognized employee stock-based compensation expense of $3.9 million and $12.1 million for the three and nine months ended September 30, 2015, respectively, and $4.0 million and $12.6 million for the three and nine months ended September 30, 2014, respectively. Employee stock-based compensation expense includes expense related to stock option grants, RSU awards, PVRSU awards and stock purchased under the ESPP. Employee stock-based compensation expense is calculated based on awards expected to vest and has been reduced for estimated forfeitures. Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Employee stock-based compensation expense also includes expense related to stock options granted to outside directors of the Company. Valuation Assumptions The Company values its stock option grants using the Black-Scholes option valuation model. Option valuation models require the input of highly subjective assumptions that can vary over time. The Company’s assumptions regarding expected volatility are based on the historical volatility of the Company’s common stock. The expected life of options granted is estimated based on historical option exercise data and assumptions related to unsettled options. The risk-free interest rate is estimated using published rates for U.S. Treasury securities with a remaining term approximating the expected life of the options granted. The Company uses a dividend yield of zero as it has never paid cash dividends and does not anticipate paying cash dividends in the foreseeable future. |
Segment Information
Segment Information | 9 Months Ended |
Sep. 30, 2015 | |
Segment Information | |
Segment Information | Note 7. Segment Information The Company operates in one business segment, which primarily focuses on the development and global commercialization of genomic based clinical laboratory services that analyze the underlying biology of cancer, allowing physicians and patients to make individualized treatment decisions. As of September 30, 2015, the majority of the Company’s product revenues have been derived from sales of one product, the Onco type DX breast cancer test. The following table summarizes total revenue from customers by geographic region. Product revenues are attributed to countries based on ship-to location. Three Months Ended Nine Months Ended September 30, September 30, 2015 2014 2015 2014 (In thousands) (In thousands) United States $ $ $ $ Outside of the United States Total revenues $ $ $ $ |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2015 | |
Income Taxes | |
Income Taxes | Note 8. Income Taxes The Company recorded income tax expense of $ 6.3 million and an income tax benefit of $ 410,000 for the three and nine months ended September 30, 2015, respectively, which was computed using the “discrete” (or “cut-off”) method. The income tax expense and benefit for the three and nine months ended September 30, 2015 are principally comprised of a deferred tax expense and a deferred tax benefit generated by the unrealized gain recognized during the period on available-for-sale marketable securities, which is included in other comprehensive income. The intraperiod tax allocation rules limit the amount of benefit recognized to the lesser of year-to-date pre-tax loss or year-to-date unrealized gain recognized on available-for-sale marketable securities included in other comprehensive income. Therefore, the tax benefit will change accordingly in subsequent periods. The deferred tax expense of $6.2 million recorded in the three months ended September 30, 2015 was increased by $96,000 of miscellaneous state income tax and foreign income tax expense. The deferred tax benefit of $765,000 recorded in the nine months ended September 30, 2015 was offset by $355,000 of miscellaneous state income tax and foreign income tax expense. Income tax expense for the three and nine months ended September 30, 2014 was $129,000 and $292,000 , respectively, which was computed using the same method and was principally comprised of state income taxes and foreign taxes. Based on all available objective evidence, the Company believes that it is more likely than not that its net deferred tax assets will not be fully realized. Accordingly, the Company maintained a valuation allowance against all of its net deferred tax assets as of each of September 30, 2015 and December 31, 2014. The Company will continue to maintain a full valuation allowance until there is sufficient evidence to support recoverability of its deferred tax assets. The Company had $1.6 million of unrecognized tax benefits at each of September 30, 2015 and December 31, 2014. The Company does not anticipate a material change to its unrecognized tax benefits over the next 12 months that would affect its effective tax rate. Unrecognized tax benefits may change during the next 12 months for items that arise in the ordinary course of business. Accrued interest and penalties related to unrecognized tax benefits are recognized as part of the Company’s income tax provision in its condensed consolidated statements of operations. The statute of limitations remain open for the years 2000 through 2015 in U.S. federal and state jurisdictions, and for the years 2010 through 2015 in foreign jurisdictions. |
Organization and Summary of S16
Organization and Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2015 | |
Organization and Summary of Significant Accounting Policies | |
Principles of Consolidation | Principles of Consolidation The accompanying condensed consolidated financial statements include all the accounts of the Company and its wholly-owned subsidiaries. The Company had two wholly-owned subsidiaries at September 30, 2015: Genomic Health International Holdings, LLC, which was established in Delaware in 2010 and supports the Company’s international sales and marketing efforts; and Oncotype Laboratories, Inc., which was established in 2012, and is inactive. Genomic Health International Holdings, LLC has 10 wholly-owned subsidiaries. The functional currency for the Company’s wholly-owned subsidiaries incorporated outside the United States is the U.S. dollar. All significant intercompany balances and transactions have been eliminated. |
Basis of Presentation and Use of Estimates | Basis of Presentation and Use of Estimates The accompanying interim period condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”). The condensed consolidated balance sheet as of September 30, 2015, condensed consolidated statements of operations and comprehensive income (loss) for the three and nine months ended September 30, 2015 and 2014, and condensed consolidated statements of cash flows for the nine months ended September 30, 2015 and 2014 are unaudited, but include all adjustments, consisting only of normal recurring adjustments, which the Company considers necessary for a fair presentation of its financial position, operating results and cash flows for the periods presented. The condensed consolidated balance sheet at December 31, 2014 has been derived from audited financial statements, but it does not include certain information and notes required by GAAP for complete consolidated financial statements. The preparation of financial statements in conformity with GAAP requires management to make judgments, assumptions and estimates that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosures in the Company’s condensed consolidated financial statements and accompanying notes. Actual results could differ materially from those estimates. The accompanying interim period condensed consolidated financial statements and related financial information should be read in conjunction with the audited consolidated financial statements and the related notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2014. Certain reclassifications have been made to prior period amounts to conform to the current period presentation. For the three and nine months ended September 30, 2014, a reclassification of certain expenses from research and development to selling and marketing was made in the condensed consolidated statements of operations to conform to the current period presentation. |
Revenue Recognition | Revenue Recognition The Company derives its revenues from product sales. The majority of the Company’s historical product revenues have been derived from the sale of the Onco type DX breast cancer test. The Company generally bills third ‑party payors upon generation and delivery of a patient report to the physician. As such, the Company takes assignment of benefits and the risk of collection with the third ‑party payor. The Company generally bills the patient directly for amounts owed after multiple requests for payment have been denied or only partially paid by the insurance carrier. The Company pursues case ‑by ‑case reimbursement where medical policies are not in place or payment history has not been established. The Company’s product revenues for tests performed are recognized when the following revenue recognition criteria are met: (1) persuasive evidence that an arrangement exists; (2) delivery has occurred or services have been rendered; (3) the fee is fixed or determinable; and (4) collectability is reasonably assured. Criterion (1) is satisfied when the Company has an arrangement to pay or a contract with the payor in place addressing reimbursement for the Onco type DX test. In the absence of such arrangements, the Company considers that criterion (1) is satisfied when a third ‑party payor pays the Company for the test performed. Criterion (2) is satisfied when the Company performs the test and generates and delivers to the physician, or makes available on its web portal, a patient report. When evaluating whether the fee is fixed or determinable and collectible, the Company considers whether it has sufficient history to reliably estimate the total fee that will be received from a payor and a payor’s individual payment patterns. Determination of criteria (3) and (4) are based on management’s judgments regarding whether the fee charged for products or services delivered is fixed or determinable, and the collectability of those fees under any contract or arrangement. Based upon at least several months of payment history, the Company reviews the number of tests paid against the number of tests billed and the payor’s outstanding balance for unpaid tests to determine whether payments are being made at a consistently high percentage of tests billed and at appropriate amounts given the arrangement or contracted payment amount. The estimated accrual amounts per test, recorded upon delivery of a patient report, are calculated for each accrual payor and are based on the arrangement or contracted price adjusted for individual payment patterns resulting from co-payment amounts and excluded services in healthcare plans. The Company also reduces sales for an estimate of amounts that qualify as patient assistance and related deductions that do not qualify for revenue recognition. When a payment received for an individual test is either higher or lower than the estimated accrual amount, the Company recognizes the difference as either cash revenue, in the case of higher payments, or in the case of lower payments, a charge against either the patient assistance program and related deductions reserve or the allowance for doubtful accounts, as applicable. To the extent all criteria set forth above are not met when test results are delivered, product revenues are recognized when cash is received from the payor. The Company has exclusive distribution agreements for one or more of its Onco type DX tests with distributors covering more than 90 countries. The distributor generally provides certain marketing and administrative services to the Company within its territory. As a condition of these agreements, the distributor generally pays the Company an agreed upon fee per test and the Company processes the tests. The same revenue recognition criteria described above generally apply to tests received through distributors. To the extent all criteria set forth above are not met when test results are delivered, product revenues are generally recognized when cash is received from the distributor. From time to time, the Company receives requests for refunds of payments, generally due to overpayments made by third-party payors. Upon becoming aware of a refund request, the Company establishes an accrued liability for tests covered by the refund request until such time as the Company determines whether or not a refund is due. Accrued refunds were $532,000 and $944,000 at September 30, 2015 and December 31, 2014, respectively, and are included in accrued expenses and other current liabilities. Advance payments received in excess of revenues recognized are classified as deferred revenue until such time as the revenue recognition criteria have been met. |
Allowance for Doubtful Accounts | Allowance for Doubtful Accounts The Company accrues an allowance for doubtful accounts against its accounts receivable based on estimates consistent with historical payment experience. Bad debt expense is included in general and administrative expense on the Company’s condensed consolidated statements of operations. Accounts receivable are written off against the allowance when the appeals process is exhausted, when an unfavorable coverage decision is received or when there is other substantive evidence that the account will not be paid. The Company’s allowance for doubtful accounts as of September 30, 2015 and December 31, 2014 was $3.9 million and $ 3.6 million, respectively. Write-offs for doubtful accounts of $1.7 million and $4.0 million were recorded against the allowance during the three and nine months ended September 30, 2015, respectively, and write-offs of $1.0 million and $4.0 million were recorded against the allowance during the three and nine months ended September 30, 2014, respectively. Bad debt expense was $2.1 million and $4.7 million for the three and nine months ended September 30, 2015, respectively, and $1.7 million and $4.8 million for the three and nine months ended September 30, 2014, respectively. |
Investments in Equity Securities | Investments in Equity Securities Beginning in 2011, the Company made investments in various tranches of the preferred stock of Invitae Corporation (“Invitae”), which at the time was a privately-held company, such that the carrying value of this investment was $13.9 million at December 31, 2014. On February 18, 2015, Invitae completed an initial public offering of its common stock and the Company’s preferred stock investment automatically converted into 2,207,793 shares of Invitae common stock. This investment is accounted for under the cost method as an available-for-sale marketable security and valued at $15.9 million at September 30, 2015. Unrealized gains or losses resulting from changes in the fair value of this investment will be recorded in other comprehensive income until the securities are sold. These securities were subject to a lock-up agreement that expired in August 2015 and continue to be subject to the resale limitations of Rule 144 under the Securities Act of 1933. |
Property and Equipment | Property and Equipment Property and equipment, including purchased and internally developed software are stated at cost. Depreciation is calculated using the straight ‑line method over the estimated useful lives of the assets, which generally range from three to seven years. Leasehold improvements are amortized using the straight ‑line method over the estimated useful lives of the assets or the remaining term of the lease, whichever is shorter. The Company wrote off $57,000 and $635,000 of previously capitalized software costs for the three and nine months ended September 30, 2015, respectively. |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements In April 2015, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update No. 2015-05, Intangibles - Goodwill and Other - Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Fees Paid in a Cloud Computing Arrangement (“ASU 2015-05”). This amendment provides guidance to help entities determine whether a cloud computing arrangement contains a software license that should be accounted for as internal-use software or as a service contract. ASU 2015-05 is effective for interim and annual reporting periods beginning after December 15, 2015, with early adoption permitted. Upon adoption, an entity has the option to apply the provisions of ASU 2015-05 either prospectively to all arrangements entered into or materially modified, or retrospectively. The Company does not expect the impact of the adoption of ASU 2015-05 to be material to its consolidated financial statements. In May 2014, the FASB issued Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers (“ASU 2014-09”) to provide guidance on revenue recognition. ASU 2014-09 requires a company to recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. In doing so, companies will need to use more judgment and make more estimates than under current guidance. These may include identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each separate performance obligation. In July 2015, the FASB deferred the effective date for annual reporting periods beginning after December 15, 2017 (including interim reporting periods within those periods). Early adoption is permitted to the original effective date of December 15, 2016 (including interim reporting periods within those periods). The amendments may be applied retrospectively to each prior period presented or retrospectively with the cumulative effect recognized as of the date of initial application. The Company is currently evaluating the impact of adopting ASU 2014-09 on its consolidated financial statements. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Fair Value Measurements | |
Schedule of financial instruments measured at fair value on recurring basis | Actively Quoted Significant Markets for Other Significant Identical Observable Unobservable Balance at Assets Inputs Inputs September 30, Level 1 Level 2 Level 3 2015 (In thousands) As of September 30, 2015: Assets Money market deposits $ $ — $ — $ Commercial paper — — Corporate debt securities — — Corporate equity securities — — Total $ $ $ — $ Actively Quoted Significant Markets for Other Significant Identical Observable Unobservable Balance at Assets Inputs Inputs December 31, Level 1 Level 2 Level 3 2014 (In thousands) As of December 31, 2014: Assets Money market deposits $ $ — $ — $ Commercial paper — — Corporate debt securities — — Total $ $ $ — $ |
Summary of available-for-sale marketable securities | September 30, 2015 Amortized Unrealized Unrealized Estimated Cost Gains Losses Fair Value (In thousands) Commercial paper $ $ $ — $ Corporate debt securities Corporate equity securities — Total $ $ $ $ December 31, 2014 Amortized Unrealized Unrealized Estimated Cost Gains Losses Fair Value (In thousands) Commercial paper $ $ $ — $ Corporate debt securities — Total $ $ $ $ |
Commitments (Tables)
Commitments (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Commitments | |
Schedule of future non-cancelable commitments under operating leases | Annual Payments (In thousands) Years Ending December 31, 2015 (remainder of year) $ 2016 2017 2018 2019 Total minimum payments $ |
Segment Information (Tables)
Segment Information (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Segment Information | |
Summary of total revenue from customers by geographic region | Three Months Ended Nine Months Ended September 30, September 30, 2015 2014 2015 2014 (In thousands) (In thousands) United States $ $ $ $ Outside of the United States Total revenues $ $ $ $ |
Organization and Summary of S20
Organization and Summary of Significant Accounting Policies Principles of Consolidation (Details) | Feb. 18, 2015shares | Sep. 30, 2015USD ($) | Sep. 30, 2014USD ($) | Sep. 30, 2015USD ($)subsidiaryTestcountry | Sep. 30, 2014USD ($) | Dec. 31, 2014USD ($) |
Principles of Consolidation | ||||||
Number of wholly-owned subsidiaries | subsidiary | 2 | |||||
Revenue Recognition | ||||||
Minimum Number of Tests by Exclusive Distribution Agreements | Test | 1 | |||||
Minimum Number of Countries Covered for Exclusive Distribution Agreements | country | 90 | |||||
Accrued refunds | $ 532,000 | $ 532,000 | $ 944,000 | |||
Allowance for Doubtful Accounts | ||||||
Allowance for doubtful accounts | 3,900,000 | 3,900,000 | 3,600,000 | |||
Allowance for Doubtful Accounts Receivable, Write-offs | 1,700,000 | $ 1,000,000 | 4,000,000 | $ 4,000,000 | ||
Bad debt expense | 2,100,000 | $ 1,700,000 | $ 4,700,000 | $ 4,800,000 | ||
Property and equipment | Minimum | ||||||
Property and Equipment and Internal-Use Software | ||||||
Estimated useful lives of the assets | 3 years | |||||
Property and equipment | Maximum | ||||||
Property and Equipment and Internal-Use Software | ||||||
Estimated useful lives of the assets | 7 years | |||||
Software costs | ||||||
Property and Equipment and Internal-Use Software | ||||||
Capital expenditure written off | $ 57,000 | $ 635,000 | ||||
Invitae | ||||||
Investments in Privately Held Companies | ||||||
Carrying value of investments in privately held companies | $ 13,900,000 | |||||
Initial public offering of its common stock and converted to common stock (in shares) | shares | 2,207,793 | |||||
Available-for-sale marketable security | $ 15,900,000 | |||||
Genomic Health International Holdings, LLC | ||||||
Principles of Consolidation | ||||||
Number of wholly-owned subsidiaries | subsidiary | 10 |
Net Loss Per Share (Details)
Net Loss Per Share (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Options to purchase common stock | ||||
Net Loss Per Share | ||||
Awards outstanding but not included in the computation of diluted net income (loss) per share (in shares) | 671,000 | 1,000,000 | 853,000 | |
Restricted Stock Units | ||||
Net Loss Per Share | ||||
Awards outstanding but not included in the computation of diluted net income (loss) per share (in shares) | 106,000 | 139,000 | 116,000 | 109,000 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 | Sep. 30, 2014 |
Assets measured at fair value on a recurring basis: | |||
Transfer of assets from level 1 to level 2 | $ 0 | $ 0 | |
Transfer of assets from level 2 to level 1 | 0 | 0 | |
Transfer of liabilities from level 1 to level 2 | 0 | 0 | |
Transfer of liabilities from level 2 to level 1 | 0 | $ 0 | |
Recurring basis | |||
Assets measured at fair value on a recurring basis: | |||
Total assets at fair value | 89,884 | $ 88,581 | |
Recurring basis | Money market deposits | |||
Assets measured at fair value on a recurring basis: | |||
Total assets at fair value | 19,130 | 12,397 | |
Recurring basis | Commercial paper | |||
Assets measured at fair value on a recurring basis: | |||
Total assets at fair value | 18,749 | 29,749 | |
Recurring basis | Corporate debt securities | |||
Assets measured at fair value on a recurring basis: | |||
Total assets at fair value | 36,065 | 46,435 | |
Recurring basis | Corporate equity securities | |||
Assets measured at fair value on a recurring basis: | |||
Total assets at fair value | 15,940 | ||
Recurring basis | Actively Quoted Markets for Identical Assets Level 1 | |||
Assets measured at fair value on a recurring basis: | |||
Total assets at fair value | 19,130 | 12,397 | |
Recurring basis | Actively Quoted Markets for Identical Assets Level 1 | Money market deposits | |||
Assets measured at fair value on a recurring basis: | |||
Total assets at fair value | 19,130 | 12,397 | |
Recurring basis | Significant Other Observable Inputs Level 2 | |||
Assets measured at fair value on a recurring basis: | |||
Total assets at fair value | 70,754 | 76,184 | |
Recurring basis | Significant Other Observable Inputs Level 2 | Commercial paper | |||
Assets measured at fair value on a recurring basis: | |||
Total assets at fair value | 18,749 | 29,749 | |
Recurring basis | Significant Other Observable Inputs Level 2 | Corporate debt securities | |||
Assets measured at fair value on a recurring basis: | |||
Total assets at fair value | 36,065 | $ 46,435 | |
Recurring basis | Significant Other Observable Inputs Level 2 | Corporate equity securities | |||
Assets measured at fair value on a recurring basis: | |||
Total assets at fair value | $ 15,940 |
Fair Value Measurements Availab
Fair Value Measurements Available-For-Sale Marketable Securities (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Dec. 31, 2014 | |
Marketable securities classified as available-for-sale | ||||
Amortized Cost | $ 67,906 | $ 67,906 | $ 73,949 | |
Unrealized Gains | 2,101 | 2,101 | 19 | |
Unrealized Losses | (4) | (4) | (34) | |
Estimated Fair Value | 70,003 | $ 70,003 | $ 73,934 | |
Realized gains on available-for-sale marketable securities | 0 | $ 0 | ||
Realized losses on available-for-sale marketable securities | 0 | $ 0 | ||
Available For Sale Marketable Securities Maturity Maximum | 1 year | 1 year | ||
Commercial paper | ||||
Marketable securities classified as available-for-sale | ||||
Amortized Cost | 18,732 | $ 18,732 | $ 29,730 | |
Unrealized Gains | 17 | 17 | 19 | |
Estimated Fair Value | 18,749 | 18,749 | 29,749 | |
Corporate debt securities | ||||
Marketable securities classified as available-for-sale | ||||
Amortized Cost | 35,317 | 35,317 | 44,219 | |
Unrealized Gains | 1 | 1 | ||
Unrealized Losses | (4) | (4) | (34) | |
Estimated Fair Value | 35,314 | 35,314 | $ 44,185 | |
Corporate equity securities | ||||
Marketable securities classified as available-for-sale | ||||
Amortized Cost | 13,857 | 13,857 | ||
Unrealized Gains | 2,083 | 2,083 | ||
Estimated Fair Value | $ 15,940 | $ 15,940 |
Collaboration and Commercial 24
Collaboration and Commercial Technology Licensing Agreements (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2015 | Mar. 31, 2015 | Sep. 30, 2014 | Dec. 31, 2013 | Sep. 30, 2015 | Sep. 30, 2014 | |
Research and development expense. | ||||||
Collaboration and Commercial Technology Licensing Agreements | ||||||
Milestone payment | $ 5,500,000 | |||||
Specimen transfer agreements | ||||||
Collaboration and Commercial Technology Licensing Agreements | ||||||
Collaboration expense | $ 1,400,000 | $ 1,900,000 | $ 10,800,000 | $ 4,100,000 | ||
Oncotype DX DCIS score agreement | ||||||
Fixed annual payments | ||||||
Capitalized milestone payment | 1,700,000 | |||||
2,015 | 604,000 | 604,000 | ||||
2,016 | 604,000 | 604,000 | ||||
2,017 | 504,000 | 504,000 | ||||
Exclusive license agreement | Research and development expense. | ||||||
Collaboration and Commercial Technology Licensing Agreements | ||||||
Up-front payment | $ 9,000,000 | |||||
Technology license agreements | Cost of product revenues | ||||||
Collaboration and Commercial Technology Licensing Agreements | ||||||
Costs recorded under collaborative arrangements | $ 2,300,000 | $ 2,400,000 | $ 6,900,000 | $ 7,200,000 |
Commitments (Details)
Commitments (Details) | 1 Months Ended | ||||||||
Aug. 31, 2013ft² | Nov. 30, 2010 | Oct. 31, 2009USD ($)ft² | Sep. 30, 2015USD ($) | Jul. 31, 2014USD ($)ft² | May. 31, 2014ft² | May. 31, 2010ft² | Jan. 31, 2007USD ($)ft² | Sep. 30, 2005USD ($)ft² | |
Non-cancelable commitments under operating leases | |||||||||
2015 (remainder of year) | $ 986,000 | ||||||||
2,016 | 3,871,000 | ||||||||
2,017 | 3,867,000 | ||||||||
2,018 | 2,476,000 | ||||||||
2,019 | 504,000 | ||||||||
Total minimum payments | $ 11,704,000 | ||||||||
Leased laboratory and office space located in Redwood City, California | |||||||||
Non-cancelable operating leases | |||||||||
Area leased under non-cancelable operating lease agreement (in square feet) | ft² | 48,000 | ||||||||
Period of time for which entity has an option to extend lease term | 5 years | ||||||||
Lease incentive obligations | $ 834,000 | ||||||||
Leased laboratory and office space located near the leased facility in Redwood City, California | |||||||||
Non-cancelable operating leases | |||||||||
Area leased under non-cancelable operating lease agreement (in square feet) | ft² | 48,000 | ||||||||
Period of time for which entity has an option to extend lease term | 5 years | ||||||||
Lease incentive obligations | $ 283,000 | ||||||||
Leased office space located near the leased facility in Redwood City, California | |||||||||
Non-cancelable operating leases | |||||||||
Area leased under non-cancelable operating lease agreement (in square feet) | ft² | 30,500 | ||||||||
Period of time for which entity has an option to extend lease term | 5 years | ||||||||
Lease incentive obligations | $ 307,000 | ||||||||
Second leased laboratory and office space located near the leased facility in Redwood City, California | |||||||||
Non-cancelable operating leases | |||||||||
Area leased under non-cancelable operating lease agreement (in square feet) | ft² | 18,400 | ||||||||
Period of time for which entity has an option to extend lease term | 5 years | ||||||||
Additional area leased (in square feet) | ft² | 5,500 | ||||||||
Lease incentive obligations | $ 358,000 | ||||||||
Leased office space located in Geneva, Switzerland | European subsidiary | |||||||||
Non-cancelable operating leases | |||||||||
Area leased under non-cancelable operating lease agreement (in square feet) | ft² | 2,500 | ||||||||
Additional area leased (in square feet) | ft² | 5,000 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Employee Stock-Based Compensation Expense | ||||
Allocated Share-based Compensation Expense | $ 3,900,000 | $ 4,000,000 | $ 12,100,000 | $ 12,600,000 |
Weighted-average fair values and assumptions used in calculation of fair value | ||||
Dividend yield (as a percent) | 0.00% | 0.00% | ||
Employee Stock Purchase Plan | ||||
Stock awards other than options | ||||
Shares of common stock issued | 108,674 | 108,674 | ||
Employee Stock Purchase Plan | ||||
Shares of common stock reserved for issuance under the ESPP | 1,250,000 | 1,250,000 | ||
Shares of common stock available for future grant | 651,064 | 651,064 | ||
Unrecognized compensation expense (in dollars) | $ 222,000 | $ 222,000 | ||
Weighted-average period of recognition of unrecognized stock-based compensation expense | 2 months | |||
Employee Stock Options | ||||
Stock Option Grants | ||||
Options granted (in shares) | 17,000 | 0 | 449,667 | 442,010 |
Stock Options | ||||
Stock Option Grants | ||||
Options exercised (in shares) | 69,123 | 166,090 | 335,192 | 424,840 |
Options exercised (in dollars per share) | $ 12.62 | $ 15.47 | $ 15.70 | $ 12.85 |
Performance Shares | ||||
Stock Option Grants | ||||
Options granted (in shares) | 0 | 0 | 148,100 | 0 |
Granted (in shares) | 22,980 | 44,630 | ||
Weighted-average grant date fair value (in dollars per share) | $ 31.12 | $ 27.21 | ||
Stock awards other than options | ||||
Grant-date fair value (in dollars) | $ 715,000 | $ 1,200,000 | ||
Grant-date fair value outstanding (in dollars) | $ 883,000 | $ 883,000 | ||
Stock outstanding (in shares) | 29,133 | 29,133 | ||
Performance Shares | Service-Based Vesting | ||||
Stock Option Grants | ||||
Weighted-average grant date fair value (in dollars per share) | $ 27.21 | |||
Stock awards other than options | ||||
Shares of common stock issued | 4,227 | |||
Restricted Stock Units | ||||
Stock Option Grants | ||||
Granted (in shares) | 19,319 | 21,970 | 403,825 | 367,157 |
Weighted-average grant date fair value (in dollars per share) | $ 27.46 | $ 27.64 | $ 30.85 | $ 29.07 |
Stock awards other than options | ||||
Grant-date fair value (in dollars) | $ 530,000 | $ 607,000 | $ 12,500,000 | $ 10,700,000 |
Number of shares of common stock to be received for each restricted stock unit | 1 | |||
Restricted Stock Units | Service-Based Vesting | ||||
Stock Option Grants | ||||
Weighted-average grant date fair value (in dollars per share) | $ 31.72 | $ 30.69 | $ 29.79 | $ 28.30 |
Stock awards other than options | ||||
Shares of common stock issued | 9,780 | 9,901 | 174,997 | 182,574 |
Restricted Stock Units | Employees | Annual vesting over vesting period | ||||
Stock awards other than options | ||||
Vesting percentage | 33.00% | |||
Vesting period | 3 years | |||
Restricted Stock | Outside directors | ||||
Stock Option Grants | ||||
Granted (in shares) | 1,825 | 2,148 | 5,025 | 6,109 |
Weighted-average grant date fair value (in dollars per share) | $ 27.34 | $ 27.86 | $ 29.79 | $ 27.78 |
Stock awards other than options | ||||
Grant-date fair value (in dollars) | $ 50,000 | $ 60,000 | $ 150,000 | $ 170,000 |
Segment Information (Details)
Segment Information (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015USD ($)product | Sep. 30, 2014USD ($) | Sep. 30, 2015USD ($)segmentproduct | Sep. 30, 2014USD ($) | |
Segment information | ||||
Number of business segments in which the entity operates | segment | 1 | |||
Number of products from which the majority of the entity's product revenues have been derived | product | 1 | 1 | ||
Total revenues | $ 73,554 | $ 69,101 | $ 212,325 | $ 206,580 |
United States | ||||
Segment information | ||||
Total revenues | 63,051 | 57,777 | 181,459 | 171,863 |
Outside of the United States | ||||
Segment information | ||||
Total revenues | $ 10,503 | $ 11,324 | $ 30,866 | $ 34,717 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | Dec. 31, 2014 | |
Income tax (benefit) expense | $ 6,301,000 | $ 129,000 | $ (410,000) | $ 292,000 | |
Deferred tax expense | 6,200,000 | (765,000) | |||
Unrecognized tax benefits | 1,600,000 | 1,600,000 | $ 1,600,000 | ||
State and foreign tax authority | |||||
Income tax (benefit) expense | $ 96,000 | $ 355,000 |