Document_and_Entity_Informatio
Document and Entity Information (USD $) | 12 Months Ended | ||
In Millions, except Share data, unless otherwise specified | Dec. 31, 2014 | Mar. 02, 2015 | Jun. 30, 2014 |
Document and Entity Information | |||
Entity Registrant Name | VERACYTE, INC. | ||
Entity Central Index Key | 1384101 | ||
Document Type | 10-K | ||
Document Period End Date | 31-Dec-14 | ||
Amendment Flag | FALSE | ||
Current Fiscal Year End Date | -19 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Public Float | $122.40 | ||
Entity Common Stock, Shares Outstanding | 22,551,242 | ||
Document Fiscal Year Focus | 2014 | ||
Document Fiscal Period Focus | FY |
CONSOLIDATED_BALANCE_SHEETS
CONSOLIDATED BALANCE SHEETS (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Current assets: | ||
Cash and cash equivalents | $35,014 | $71,220 |
Accounts receivable, net of allowance of $84 and $107 as of December 31, 2014 and 2013 | 3,050 | 1,143 |
Supplies inventory | 3,696 | 2,567 |
Prepaid expenses and other current assets | 1,218 | 1,477 |
Deferred tax asset | 300 | |
Restricted cash | 70 | |
Total current assets | 43,348 | 76,407 |
Property and equipment, net | 4,161 | 2,952 |
In-process research and development | 16,000 | |
Goodwill | 1,057 | |
Restricted cash | 118 | 118 |
Other assets | 155 | 153 |
Total assets | 64,839 | 79,630 |
Current liabilities: | ||
Accounts payable | 7,397 | 5,294 |
Accrued liabilities | 7,851 | 7,594 |
Deferred Genzyme co-promotion fee | 1,897 | 2,500 |
Total current liabilities | 17,145 | 15,388 |
Long-term debt | 4,923 | 4,899 |
Deferred tax liability | 300 | |
Deferred rent, net of current portion | 149 | 286 |
Deferred Genzyme co-promotion fee, net of current portion | 948 | 2,614 |
Total liabilities | 23,465 | 23,187 |
Commitments and contingencies (Note 7) | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value; 5,000,000 shares authorized, 0 shares issued and outstanding as of December 31, 2014 and 2013 | ||
Common stock, $0.001 par value; 125,000,000 shares authorized, 22,523,529 and 21,143,313 shares issued and outstanding as of December 31, 2014 and 2013 | 23 | 21 |
Additional paid-in capital | 156,373 | 142,071 |
Accumulated deficit | -115,022 | -85,649 |
Total stockholders' equity | 41,374 | 56,443 |
Total liabilities and stockholders' equity | $64,839 | $79,630 |
CONSOLIDATED_BALANCE_SHEETS_Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, except Share data, unless otherwise specified | ||
CONSOLIDATED BALANCE SHEETS | ||
Accounts receivable, allowance (in dollars) | $84 | $107 |
Preferred stock, par value (in dollars per share) | $0.00 | $0.00 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $0.00 | $0.00 |
Common stock, shares authorized | 125,000,000 | 125,000,000 |
Common stock, shares issued | 22,523,529 | 21,143,313 |
Common stock, shares outstanding | 22,523,529 | 21,143,313 |
CONSOLIDATED_STATEMENTS_OF_OPE
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (USD $) | 12 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | |||
Revenue | $38,190 | $21,884 | $11,628 |
Operating expenses: | |||
Cost of revenue | 16,606 | 12,607 | 7,584 |
Research and development | 9,804 | 7,810 | 6,608 |
Selling and marketing | 21,932 | 12,540 | 8,447 |
General and administrative | 18,854 | 12,100 | 7,918 |
Total operating expenses | 67,196 | 45,057 | 30,557 |
Loss from operations | -29,006 | -23,173 | -18,929 |
Interest expense | -439 | -233 | |
Other income (expense), net | 72 | -2,174 | 280 |
Net loss | -29,373 | -25,580 | -18,649 |
Comprehensive loss | ($29,373) | ($25,580) | ($18,649) |
Net loss per common share, basic and diluted (in dollars per share) | ($1.36) | ($6.15) | ($28.68) |
Shares used to compute net loss per common share, basic and diluted (in shares) | 21,639,374 | 4,158,664 | 650,333 |
CONSOLIDATED_STATEMENTS_OF_CON
CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) (USD $) | Convertible Preferred Stock. | Series C | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Total |
In Thousands, except Share data, unless otherwise specified | ||||||
Balance at Dec. 31, 2011 | $1 | $653 | ($41,420) | ($40,766) | ||
Balance at Dec. 31, 2011 | 49,296 | |||||
Balance (in shares) at Dec. 31, 2011 | 594,941 | |||||
Balance (in shares) at Dec. 31, 2011 | 45,147,999 | |||||
Increase (Decrease) in Convertible Preferred Stock and Stockholders' Equity (Deficit) | ||||||
Issuance of convertible preferred stock, net of issuance costs and preferred stock liability | 14,076 | |||||
Issuance of convertible preferred stock, net of issuance costs and preferred stock liability (in shares) | 7,936,508 | |||||
Issuance of common stock on exercise of stock options | 76 | 76 | ||||
Issuance of common stock on exercise of stock options (in shares) | 72,743 | 72,743 | ||||
Stock-based compensation expense (employee) | 590 | 590 | ||||
Stock-based compensation expense (non-employee) | 85 | 85 | ||||
Equity-based compensation | 193 | 193 | ||||
Net loss | -18,649 | -18,649 | ||||
Comprehensive loss | -18,649 | -18,649 | ||||
Balance at Dec. 31, 2012 | 1 | 1,597 | -60,069 | -58,471 | ||
Balance (in shares) at Dec. 31, 2012 | 667,684 | |||||
Balance at Dec. 31, 2012 | 63,372 | |||||
Balance (in shares) at Dec. 31, 2012 | 53,084,507 | |||||
Increase (Decrease) in Convertible Preferred Stock and Stockholders' Equity (Deficit) | ||||||
Issuance of convertible preferred stock, net of issuance costs and preferred stock liability | 12,997 | |||||
Issuance of convertible preferred stock, net of issuance costs and preferred stock liability (in shares) | 6,904,761 | |||||
Extinguishment of the preferred stock liability | 2,653 | |||||
Issuance of common stock on exercise of stock options | 552 | 552 | ||||
Issuance of common stock on exercise of stock options (in shares) | 377,966 | 377,966 | ||||
Issuance of common stock in initial public offering, net of discounts and commissions of $4,642 and issuance costs of $2,507 | 5 | 59,151 | 59,156 | |||
Issuance of common stock in initial public offering, net of discounts and commissions of $4,642 and issuance costs of $2,507 (in shares) | 5,100,351 | |||||
Conversion of preferred stock into common stock upon initial public offering | -79,022 | 15 | 79,007 | 79,022 | ||
Conversion of preferred stock into common stock upon initial public offering (in shares) | -59,989,268 | 14,997,312 | ||||
Reclassification of preferred stock warrant liability into additional paid-in capital upon initial public offering | 261 | 261 | ||||
Common stock subject to repurchase | -3 | -3 | ||||
Stock-based compensation expense (employee) | 1,041 | 1,041 | ||||
Stock-based compensation expense (non-employee) | 206 | 206 | ||||
Equity-based compensation | 259 | 259 | ||||
Net loss | -25,580 | -25,580 | ||||
Comprehensive loss | -25,580 | -25,580 | ||||
Balance at Dec. 31, 2013 | 21 | 142,071 | -85,649 | 56,443 | ||
Balance (in shares) at Dec. 31, 2013 | 21,143,313 | |||||
Increase (Decrease) in Convertible Preferred Stock and Stockholders' Equity (Deficit) | ||||||
Issuance of common stock on exercise of stock options | 1 | 674 | 675 | |||
Issuance of common stock on exercise of stock options (in shares) | 402,100 | 402,100 | ||||
Issuance of common stock on cashless exercise of warrant (in shares) | 13,739 | |||||
Common stock subject to repurchase | 3 | 3 | ||||
Issuance of common stock for acquisition | 1 | 10,077 | 10,078 | |||
Issuance of common stock in the merger acquisition (in shares) | 964,377 | |||||
Stock-based compensation expense (employee) | 3,388 | 3,388 | ||||
Stock-based compensation expense (non-employee) | 160 | 160 | ||||
Net loss | -29,373 | -29,373 | ||||
Comprehensive loss | -29,373 | -29,373 | ||||
Balance at Dec. 31, 2014 | $23 | $156,373 | ($115,022) | $41,374 | ||
Balance (in shares) at Dec. 31, 2014 | 22,523,529 |
CONSOLIDATED_STATEMENTS_OF_CON1
CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) (Parenthetical) (USD $) | 12 Months Ended | 0 Months Ended | 1 Months Ended | 2 Months Ended | |
Dec. 31, 2013 | Dec. 31, 2012 | Nov. 30, 2012 | Jun. 30, 2013 | Dec. 31, 2012 | |
Issuance of convertible preferred stock, preferred stock liability | $861,000 | ||||
Issuance of common stock in initial public offering, discounts and commissions | 4,642,000 | ||||
Issuance of common stock in initial public offering, issuance cost | 2,507,000 | ||||
Series C | |||||
Issuance of convertible preferred stock, issue price (in dollars per share) | $1.89 | $1.89 | $1.89 | ||
Issuance of convertible preferred stock, issuance cost | 53 | 53 | 63,000 | ||
Issuance of convertible preferred stock, preferred stock liability | $861,000 |
CONSOLIDATED_STATEMENTS_OF_CAS
CONSOLIDATED STATEMENTS OF CASH FLOWS (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Operating activities | |||
Net loss | ($29,373) | ($25,580) | ($18,649) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization | 1,175 | 999 | 706 |
Bad debt expense | 54 | 109 | 225 |
Genzyme co-promotion fee amortization | -2,269 | -2,500 | -2,386 |
Stock-based compensation | 3,548 | 1,247 | 675 |
Equity-based compensation | 259 | ||
Amortization of debt discount and issuance costs | 97 | 56 | |
Interest on debt balloon payment | 81 | 42 | |
Change in value of preferred stock liability | 2,070 | -278 | |
Change in value of preferred stock warrant liability | 86 | ||
Changes in operating assets and liabilities: | |||
Accounts receivable | -1,961 | -683 | -565 |
Supplies inventory | -1,129 | -1,517 | -771 |
Prepaid expenses and current other assets | -38 | -722 | -191 |
Other assets | -46 | 24 | -119 |
Accounts payable | 1,874 | 3,348 | 1,348 |
Accrued liabilities and deferred rent | 355 | 3,862 | 2,579 |
Deferred Genzyme co-promotion fee | 10,000 | ||
Net cash used in operating activities | -27,632 | -19,159 | -7,167 |
Investing activities | |||
Purchases of property and equipment | -2,024 | -1,332 | -1,462 |
Cash remitted for acquisition, net of cash received | -6,916 | ||
Change in restricted cash | -70 | 50 | |
Net cash used in investing activities | -9,010 | -1,282 | -1,462 |
Financing activities | |||
Proceeds from the issuance of long-term debt, net of debt issuance costs | 4,877 | ||
Payment of end-of-term obligation | -110 | ||
Proceeds from issuance of redeemable convertible preferred stock, net of issuance costs | 12,945 | 14,989 | |
Proceeds from issuance of common stock in initial public offering, gross | 66,304 | ||
Commissions and issuance costs relating to the initial public offering | -129 | -7,019 | |
Proceeds from the exercise of common stock options | 675 | 552 | 76 |
Net cash provided by financing activities | 436 | 77,659 | 15,065 |
Net increase (decrease) in cash and cash equivalents | -36,206 | 57,218 | 6,436 |
Cash and cash equivalents at beginning of period | 71,220 | 14,002 | 7,566 |
Cash and cash equivalents at end of period | 35,014 | 71,220 | 14,002 |
Supplementary cash flow information of non cash investing and financing activities: | |||
Fair value of common stock issued for acquisition | 10,078 | ||
Non-cash issuance of long-term debt | 5,000 | ||
Non-cash repayment of long-term debt | -5,000 | ||
Purchases of property and equipment included in accounts payable and accrued liabilities | 383 | 25 | 109 |
Non-cash purchases of property and equipment | 257 | ||
Preferred stock liability | 861 | ||
Transfer of preferred stock liability to equity | 2,653 | ||
Convertible preferred stock issuance costs included in accounts payable | 52 | ||
Preferred stock warrants | 175 | ||
Conversion of preferred stock warrant liability to common stock warrants | 261 | ||
Issuance of common stock from the non-cash exercise of common stock warrants | 187 | ||
Conversion of convertible preferred stock to common stock | 79,022 | ||
IPO costs included in accounts payable and accrued liabilities | 129 | ||
Cash paid for interest on debt | 307 | 132 | |
Transfer of equity-based compensation from liabilities to equity | $259 | $193 |
Organization_and_Description_o
Organization and Description of Business | 12 Months Ended |
Dec. 31, 2014 | |
Organization and Description of Business | |
Organization and Description of Business | |
1. Organization and Description of Business | |
Veracyte, Inc. (the "Company") was incorporated in the state of Delaware on August 15, 2006 as Calderome, Inc. Calderome operated as an incubator until early 2008. On March 4, 2008, the Company changed its name to Veracyte, Inc. Veracyte is a diagnostics company pioneering the field of molecular cytology to improve patient outcomes and lower healthcare costs. The Company specifically targets diseases that often require invasive procedures for an accurate diagnosis—diseases where many healthy patients undergo costly interventions that ultimately prove unnecessary. The Company improves the accuracy of diagnosis at an earlier stage of patient care by deriving clinically actionable genomic information from cytology samples. | |
The Company's first commercial solution, the Afirma® Thyroid FNA Analysis, includes as its centerpiece the Gene Expression Classifier ("GEC"). The GEC helps physicians reduce the number of unnecessary surgeries by employing a proprietary 142-gene signature to preoperatively determine whether thyroid nodules previously classified by cytopathology as indeterminate can be reclassified as benign. The comprehensive offering also includes cytopathology testing and the Afirma Malignancy Classifiers, launched in May 2014. The Company markets and sells Afrma through a co-promotion agreement with Genzyme Corporation, a subsidiary of Sanofi. | |
On September 16, 2014, the Company acquired Allegro Diagnostics Corp. ("Allegro") to accelerate its entry into pulmonology, the Company's second planned clinical area. Allegro was a privately-held company based in Maynard, Massachusetts, focused on the development of genomic tests to improve the preoperative diagnosis of lung cancer. See Note 4. The Company intends to enter the lung cancer diagnostics market by mid-2015 with the Percepta™ Bronchial Genomic Classifier ("Percepta"), a test designed to resolve diagnostic ambiguity among the approximately 250,000 patients in the United States who undergo bronchoscopy each year to assess potentially cancerous lung nodules. | |
The Company's operations are based in South San Francisco, California and Austin, Texas, and it operates in one segment in the United States. | |
Initial Public Offering | |
On November 4, 2013, the Company completed an initial public offering ("IPO") of its common stock. In connection with its IPO, the Company issued and sold 5,100,351 shares of common stock at a price to the public of $13.00 per share. As a result of the IPO, the Company received $59.2 million in net proceeds, after deducting underwriting discounts and commissions of $4.6 million and offering expenses of $2.5 million payable by the Company. In connection with the IPO, the Company's outstanding shares of convertible preferred stock were automatically converted into 14,997,312 shares of common stock. | |
Summary_of_Significant_Account
Summary of Significant Accounting Policies | 12 Months Ended | ||||||||||
Dec. 31, 2014 | |||||||||||
Summary of Significant Accounting Policies | |||||||||||
Summary of Significant Accounting Policies | |||||||||||
2. Summary of Significant Accounting Policies | |||||||||||
Basis of Presentation | |||||||||||
The Company's consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States ("GAAP"). The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary. All intercompany accounts and transactions have been eliminated in consolidation. | |||||||||||
Use of Estimates | |||||||||||
The preparation of the consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Significant items subject to such estimates include: revenue recognition; contractual allowances; allowance for doubtful accounts; the useful lives of property and equipment; the recoverability of long-lived assets; the estimation of the fair value of intangible assets; the determination of fair value of the Company's common stock prior to the Company's IPO; stock options; preferred stock liability; income tax uncertainties, including a valuation allowance for deferred tax assets; and contingencies. The Company bases these estimates on historical and anticipated results, trends, and various other assumptions that the Company believes are reasonable under the circumstances, including assumptions as to future events. These estimates form the basis for making judgments about the carrying values of assets and liabilities and recorded revenue and expenses that are not readily apparent from other sources. Actual results could differ from those estimates and assumptions. | |||||||||||
Liquidity | |||||||||||
The Company has incurred net losses since its inception and expects to incur additional losses in 2015 and in future years. As of December 31, 2014, the Company had an accumulated deficit of $115.0 million. The Company may never achieve revenue sufficient to offset its expenses. The Company believes its cash and cash equivalents of $35.0 million as of December 31, 2014 and its revenue from the sale of Afirma in 2015 will be sufficient to meet its anticipated cash requirements for at least the next 12 months. | |||||||||||
If the Company is not able to generate revenue to finance its cash requirements, the Company will need to finance future cash needs primarily through public or private equity offerings, debt financings, borrowings or strategic collaborations or licensing arrangements. If the Company is not able to secure additional funding when needed, on acceptable terms, it may have to delay, reduce the scope of or eliminate one or more research and development programs or selling and marketing initiatives which may have a material adverse effect on the Company's business, results of operations, financial condition and/or its ability to fund its scheduled obligations on a timely basis or at all. | |||||||||||
Concentrations of Credit Risk and Other Risks and Uncertainties | |||||||||||
The Company's cash and cash equivalents are deposited with one major financial institution in the United States, as required by the loan and security agreement discussed in Note 8. Deposits in this institution may exceed the amount of insurance provided on such deposits. The Company has not experienced any losses on its deposits of cash and cash equivalents. | |||||||||||
Several of the components of the Company's sample collection kit and test reagents are obtained from single-source suppliers. If these single-source suppliers fail to satisfy the Company's requirements on a timely basis, it could suffer delays in being able to deliver its diagnostic solution, a possible loss of revenue, or incur higher costs, any of which could adversely affect its operating results. | |||||||||||
The Company is also subject to credit risk from its accounts receivable related to its sales of Afirma. The Company generally does not perform evaluations of customers' financial condition and generally does not require collateral. | |||||||||||
Through December 31, 2014, all of the Company's revenue have been derived from the sale of Afirma. The Company's solution to date has been delivered primarily to physicians in the United States. The Company's third-party payers in excess of 10% of revenue and their related revenue as a percentage of total revenue were as follows: | |||||||||||
Year Ended | |||||||||||
December 31, | |||||||||||
2014 | 2013 | 2012 | |||||||||
Medicare | 26 | % | 32 | % | 34 | % | |||||
Aetna | 11 | % | 9 | % | 13 | % | |||||
United Healthcare | 18 | % | 18 | % | 12 | % | |||||
| | | | | | | | | | | |
55 | % | 59 | % | 59 | % | ||||||
| | | | | | | | | | | |
| | | | | | | | | | | |
As the number of payers reimbursing for Afirma increases, the percentage of revenue derived from Medicare and other significant third-party payers has changed and will continue to change as a percentage of total revenue. | |||||||||||
The Company's significant third-party payers and their related accounts receivable balance at December 31, 2014 and 2013 as a percentage of total accounts receivable are as follows: | |||||||||||
December 31, | |||||||||||
2014 | 2013 | ||||||||||
Medicare | 64 | % | 78 | % | |||||||
Aetna | 12 | % | — | ||||||||
United Healthcare | 14 | % | 3 | % | |||||||
No other third-party payer represented more than 10% of the Company's accounts receivable balances for these periods. | |||||||||||
Cash Equivalents | |||||||||||
Cash equivalents consist of short-term, highly liquid investments with original maturities of three months or less from the date of purchase. Cash equivalents consist primarily of amounts invested in a money market account primarily consisting of U.S. Treasury reserves. | |||||||||||
Restricted Cash | |||||||||||
The Company reserved $70,000 in cash as of December 31, 2014 to cover liabilities associated with the acquisition of Allegro as discussed in Note 4. This restricted cash is included in current assets on the Company's consolidated balance sheet. | |||||||||||
The Company had long-term deposits of $118,000 as of December 31, 2014 and 2013, restricted from withdrawal and held by a bank in the form of collateral for letters of credit. The balance for each period consists of a letter of credit totaling $118,000 held as security for the lease of the Company's office space in South San Francisco, California. This restricted cash is included in long-term assets on the Company's consolidated balance sheets. | |||||||||||
Allowance for Doubtful Accounts | |||||||||||
The Company estimates an allowance for doubtful accounts against its individual accounts receivable based on estimates of expected reimbursement consistent with historical payment experience in relation to the amounts billed. Bad debt expense is included in general and administrative expense on the Company's statements of operations and comprehensive loss. Accounts receivable are written off against the allowance when there is substantive evidence that the account will not be paid. | |||||||||||
The balance of allowance for doubtful accounts as of December 31, 2014 and 2013, including charges to bad debt expense and write-offs, net of recoveries, was as follows: | |||||||||||
As of | |||||||||||
December 31, | |||||||||||
2014 | 2013 | ||||||||||
(In thousands) | |||||||||||
Beginning balance | $ | 107 | $ | 222 | |||||||
Charged to expense | 54 | 109 | |||||||||
Write-offs, net of recoveries | (77 | ) | (224 | ) | |||||||
| | | | | | | | ||||
Ending balance | $ | 84 | $ | 107 | |||||||
| | | | | | | | ||||
| | | | | | | | ||||
Supplies Inventory | |||||||||||
Supplies inventory consists of test reagents and other consumables used in the sample collection kits and in cytopathology and GEC test processing and are valued at the lower of cost or market value. Cost is determined using actual costs on a first-in, first-out basis. | |||||||||||
Property and Equipment | |||||||||||
Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation is computed using the straight-line method over the estimated useful lives of the assets, generally between three and five years. Leasehold improvements are amortized using the straight-line method over the shorter of the estimated useful life of the asset or the term of the lease. Maintenance and repairs are charged to expense as incurred, and improvements and betterments are capitalized. When assets are retired or otherwise disposed of, the cost and accumulated depreciation are removed from the balance sheet and any resulting gain or loss is reflected in the statements of operations and comprehensive loss in the period realized. | |||||||||||
Internal-use Software | |||||||||||
The Company capitalizes costs incurred in the application development stage to design and implement the software used in the tracking and reporting of laboratory activity. Costs incurred in the development of application software are capitalized and amortized over an estimated useful life of three years on a straight line basis. The total cost, accumulated depreciation and net book value was $927,000, $330,000 and $597,000, respectively, as of December 31, 2014, and was $482,000, $195,000 and $287,000, respectively, as of December 31, 2013, and are included in property and equipment in the Company's consolidated balance sheets. During the years ended December 31, 2014 and 2013, the Company capitalized $445,000 and $212,000, respectively, of software development costs. Amortization expense totaled $135,000, $108,000 and $47,000 in the years ended December 31, 2014, 2013 and 2012, respectively. | |||||||||||
Business Combination | |||||||||||
The Company accounts for acquisitions using the acquisition method of accounting which requires the recognition of tangible and identifiable intangible assets acquired and liabilities assumed at their estimated fair values as of the business combination date. The Company allocates any excess purchase price over the estimated fair value assigned to the net tangible and identifiable intangible assets acquired and liabilities assumed to goodwill. Transaction costs are expensed as incurred in general and administrative expenses. Results of operations and cash flows of acquired companies are included in the Company's operating results from the date of acquisition. | |||||||||||
Goodwill | |||||||||||
Goodwill, derived from the Company's acquisition of Allegro, is reviewed for impairment on an annual basis or more frequently if events or circumstances indicate that it may be impaired. The Company's goodwill evaluation is based on both qualitative and quantitative assessments regarding the fair value of goodwill relative to its carrying value. The Company has determined that it operates in a single segment and has a single reporting unit associated with the development and commercialization of diagnostic products. In the event the Company determines that it is more likely than not the carrying value of the reporting unit is higher than its fair value, quantitative testing is performed comparing recorded values to estimated fair values. If impairment is present, the impairment loss is measured as the excess of the recorded goodwill over its implied fair value. The Company performs its annual evaluation of goodwill during the fourth quarter of each fiscal year. There was no impairment for the year ended December 31, 2014. | |||||||||||
Intangible Assets | |||||||||||
The Company's intangible assets are comprised of acquired in-process research and development, or IPR&D. The fair value of IPR&D acquired through a business combination is capitalized as an indefinite-lived intangible asset until the completion or abandonment of the related research and development activities. IPR&D is tested for impairment annually or when events or circumstances indicate that the fair value may be below the carrying value of the asset. There was no impairment for the year ended December 31, 2014. If and when research and development is complete, the associated assets would then be amortized over their estimated useful lives. | |||||||||||
Impairment of Long-lived Assets | |||||||||||
The Company annually reviews long-lived and indefinite lived assets other than goodwill for impairment or whenever events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable. The Company recognizes an impairment loss when the total of estimated future undiscounted cash flows expected to result from the use of the asset and its eventual disposition are less than its carrying amount. Impairment, if any, would be assessed using discounted cash flows or other appropriate measures of fair value. There were no impairments for the years ended December 31, 2014 and 2013. | |||||||||||
Bonus Accruals | |||||||||||
The Company accrues for liabilities under discretionary employee and executive bonus plans. These estimated compensation liabilities are based on progress against corporate objectives approved by the Board of Directors, compensation levels of eligible individuals, and target bonus percentage levels. The Board of Directors and the Compensation Committee of the Board of Directors review and evaluate the performance against these objectives and ultimately determine what discretionary payments are made. The Company accrued $1.1 million as of December 31, 2014 and 2013 for liabilities associated with these employee and executive bonus plans which are included in accrued liabilities in the Company's consolidated balance sheets. | |||||||||||
Fair Value of Financial Instruments | |||||||||||
The carrying amounts of certain financial instruments including cash and cash equivalents, accounts receivable, prepaid expenses and other current assets, accounts payable and accrued liabilities approximate fair value due to their relatively short maturities. | |||||||||||
Revenue Recognition | |||||||||||
The Company's revenue is generated from the provision of diagnostic services using the Afirma solution. The Company's service is completed upon the delivery of test results to the prescribing physician which triggers the billing for the service. The Company recognizes revenue related to billings for Medicare and commercial payers on an accrual basis, net of contractual adjustments, when a reasonable estimate of reimbursement can be made. These contractual adjustments represent the difference between the list price (the billing rate) and the reimbursement rate for each payer. Upon ultimate collection, the amount received from Medicare and commercial payers where reimbursement was estimated is compared to previous estimates and the contractual allowance is adjusted accordingly. Until a contract has been negotiated with a commercial payer or governmental program, the Afirma solution may or may not be covered by these entities' existing reimbursement policies. In addition, patients do not enter into direct agreements with the Company that commit them to pay any portion of the cost of the tests in the event that their insurance declines to reimburse the Company. In the absence of an agreement with the patient or other clearly enforceable legal right to demand payment from the patient, the related revenue is only recognized upon the earlier of payment notification, if applicable, or cash receipt. | |||||||||||
For all services performed, the Company considers whether or not the following revenue recognition criteria are met: persuasive evidence of an arrangement exists; delivery has occurred or services have been rendered; and a reasonable estimate of reimbursement can be made. | |||||||||||
Persuasive evidence of an arrangement exists and delivery is deemed to have occurred upon delivery of a patient report to the prescribing physician. The assessment of whether a reasonable estimate of reimbursement can be made requires significant judgment by management. Where management's judgment indicates a reasonable estimate of reimbursement can be made, revenue is recognized upon delivery of the patient report. Some patients have out-of-pocket costs for amounts not covered by their insurance carrier, and the Company may bill the patient directly for these amounts in the form of co-payments and co-insurance in accordance with their insurance carrier and health plans. Some payers may not cover the Company's GEC as ordered by the prescribing physician under their reimbursement policies. The Company pursues reimbursement from such patients on a case-by-case basis. In the absence of contracted reimbursement coverage or the ability to reasonably estimate reimbursement, the Company recognizes revenue upon receipt of third-party payer notification of payment or when cash is received. | |||||||||||
Revenue recognized when cash is received was $25.7 million, $14.6 million and $7.5 million for the years ended December 31, 2014, 2013 and 2012, respectively. Revenue recognized on an accrual basis was $12.5 million, $7.3 million and $4.1 million for the years ended December 31, 2014, 2013 and 2012, respectively. | |||||||||||
Cost of Revenue | |||||||||||
Cost of revenue is expensed as incurred and includes material and service costs, cytopathology testing services performed by a third-party pathology group, stock-based compensation expense, direct labor costs, equipment and infrastructure expenses associated with testing samples, shipping charges to transport samples, and allocated overhead including rent, information technology, equipment depreciation and utilities. | |||||||||||
Research and Development | |||||||||||
Research and development costs are charged to operations as incurred. Research and development costs include, but are not limited to, payroll and personnel-related expenses, stock-based compensation expense, prototype materials, laboratory supplies, consulting costs, costs associated with setting up and conducting clinical studies at domestic and international sites, and allocated overhead including rent, information technology, equipment depreciation and utilities. | |||||||||||
Income Taxes | |||||||||||
The Company accounts for income taxes under the liability method. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amounts expected to be realized. | |||||||||||
The Company assesses all material positions taken in any income tax return, including all significant uncertain positions, in all tax years that are still subject to assessment or challenge by relevant taxing authorities. The Company's assessment of an uncertain tax position begins with the initial determination of the position's sustainability and is measured at the largest amount of benefit that is more-likely-than-not of being realized upon ultimate settlement. As of each balance sheet date, unresolved uncertain tax positions must be reassessed, and the Company will determine whether (i) the factors underlying the sustainability assertion have changed and (ii) the amount of the recognized tax benefit is still appropriate. The recognition and measurement of tax benefits requires significant judgment. Judgments concerning the recognition and measurement of a tax benefit may change as new information becomes available. | |||||||||||
Stock-based Compensation | |||||||||||
Stock-based compensation expense for equity instruments issued to employees is measured based on the grant-date fair value of the awards. The fair value of each employee stock option is estimated on the date of grant using the Black-Scholes option-pricing model. The Company recognizes compensation costs on a straight-line basis for all employee stock based compensation awards that are expected to vest over the requisite service period of the awards, which is generally the awards' vesting period. Forfeitures are required to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. | |||||||||||
Equity awards issued to non-employees are valued using the Black-Scholes option-pricing model and are subject to re-measurement as the underlying equity awards vest. | |||||||||||
Net Loss per Common Share | |||||||||||
Basic net loss per common share is calculated by dividing net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period, without consideration of common stock equivalents. Diluted net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted-average number of common share equivalents outstanding for the period determined using the treasury stock method. Potentially dilutive securities consisting of options and warrants to purchase common stock are considered to be common stock equivalents and were excluded from the calculation of diluted net loss per common share because their effect would be anti-dilutive for all periods presented. | |||||||||||
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, requiring an entity to recognize the amount of revenue to which it expects to be entitled for the transfer of promised goods or services to customers. The updated standard will replace most existing revenue recognition guidance in GAAP when it becomes effective and permits the use of either the retrospective or cumulative effect transition method. Early adoption is not permitted. The updated standard becomes effective for the Company in the first quarter of fiscal 2017. The Company has not yet selected a transition method and is currently evaluating the potential effect of the updated standard on its financial statements. | |||||||||||
In August 2014, FASB issued Accounting Standards Update No. 2014-15, Presentation of Financial Statements Going Concern—Disclosure of Uncertainties about an Entity's Ability to Continue as a Going Concern. The amendments require management to assess an entity's ability to continue as a going concern by incorporating and expanding upon certain principles that are currently in U.S. auditing standards. Specifically, the amendments: (1) provide a definition of the term substantial doubt; (2) require an evaluation every reporting period including interim periods; (3) provide principles for considering the mitigating effect of management's plans; (4) require certain disclosures when substantial doubt is alleviated as a result of consideration of management's plans; (5) require an express statement and other disclosures when substantial doubt is not alleviated; and (6) require an assessment for a period of one year after the date that the financial statements are issued (or available to be issued). ASU 2014-15 will be effective for annual periods ending after December 15, 2016 and interim periods within annual periods beginning after December 15, 2016 with early adoption permitted. ASU 2014-15 will be effective for the Company beginning with its annual report for fiscal 2016 and interim periods thereafter. The Company has not yet determined the effect of the adoption of this standard on the Company's consolidated financial statements. | |||||||||||
Net_Loss_Per_Common_Share
Net Loss Per Common Share | 12 Months Ended | ||||||||||
Dec. 31, 2014 | |||||||||||
Net Loss Per Common Share | |||||||||||
Net Loss Per Common Share | |||||||||||
3. Net Loss Per Common Share | |||||||||||
The following table presents the calculation of basic and diluted net loss per common share for the years ended December 31, 2014, 2013 and 2012 (in thousands, except share and per share amounts): | |||||||||||
Year Ended | |||||||||||
December 31, | |||||||||||
2014 | 2013 | 2012 | |||||||||
Net loss | $ | (29,373 | ) | $ | (25,580 | ) | $ | (18,649 | ) | ||
| | | | | | | | | | | |
| | | | | | | | | | | |
Shares used to compute net loss per common share, basic and diluted | 21,639,374 | 4,158,664 | 650,333 | ||||||||
| | | | | | | | | | | |
| | | | | | | | | | | |
Net loss per common share, basic and diluted | $ | (1.36 | ) | $ | (6.15 | ) | $ | (28.68 | ) | ||
| | | | | | | | | | | |
| | | | | | | | | | | |
The following outstanding common stock equivalents have been excluded from diluted net loss per common share for the years ended December 31, 2014 and 2013 because their inclusion would be anti-dilutive: | |||||||||||
Year Ended | |||||||||||
December 31, | |||||||||||
2014 | 2013 | ||||||||||
Shares of common stock subject to outstanding options | 3,249,469 | 2,359,287 | |||||||||
Shares of common stock issuable upon exercise of warrants | — | 24,801 | |||||||||
| | | | | | | | ||||
Total shares of common stock equivalents | 3,249,469 | 2,384,088 | |||||||||
| | | | | | | | ||||
| | | | | | | | ||||
Business_Combination
Business Combination | 12 Months Ended | |||||||
Dec. 31, 2014 | ||||||||
Business Combination | ||||||||
Business Combination | ||||||||
4. Business Combination | ||||||||
On September 16, 2014, the Company acquired Allegro via a merger with Full Moon Acquisition, Inc., a wholly-owned subsidiary of the Company. Allegro was a privately-held company based in Maynard, Massachusetts, focused on the development of genomic tests to improve the preoperative diagnosis of lung cancer. Allegro merged with Full Moon, (the "Merger"), with Allegro surviving the Merger as a wholly-owned subsidiary of the Company. At the effective time of the Merger, each share of the common stock of Full Moon issued and outstanding immediately prior to the effective time of the Merger was automatically converted into one share of common stock of Allegro and represented the only outstanding common stock of Allegro at the effective time of the Merger; all previously issued and outstanding shares of common stock of Allegro were canceled. The Series A preferred stock of Allegro issued and outstanding immediately prior to the effective time of the Merger was canceled and automatically converted into the right to receive a total of 964,377 shares of the Company's common stock and $2.7 million in cash. Outstanding indebtedness of Allegro totaling $4.3 million was settled in cash by the Company on the effective date of the Merger. All outstanding stock options under Allegro's equity incentive plan were canceled. | ||||||||
The acquisition of Allegro is expected to accelerate the Company's molecular diagnostics business into the pulmonology diagnostics market. Allegro's lung cancer test is designed to help physicians determine which patients with lung nodules who have had a non-diagnostic bronchoscopy result are at low risk for cancer and can thus be safely monitored with CT scans rather than undergoing invasive procedures. The Company plans to launch its lung cancer test in the middle of 2015. | ||||||||
The Merger was accounted for using the acquisition method of accounting with the Company treated as the accounting acquirer. The purchase price was allocated based on the estimated fair value of the assets acquired and liabilities assumed at the date of the acquisition. | ||||||||
The Company incurred approximately $0.5 million in acquisition-related costs related to the Merger, which primarily consisted of legal, accounting and valuation-related expenses. In addition, the Company incurred $1.2 million related to transaction bonuses and severance payments to former Allegro employees associated with the Merger. These expenses were recorded in general and administrative expense in the accompanying consolidated statements of operations and comprehensive loss. Total expenses and net loss associated with the acquired Allegro business in the Company's consolidated statements of operations and comprehensive loss were not separately identifiable due to the integration with the Company's operations. | ||||||||
The acquisition consideration was comprised of (in thousands): | ||||||||
Stock | $ | 10,078 | ||||||
Cash | 2,725 | |||||||
Payment of outstanding indebtedness | 4,290 | |||||||
| | | | | ||||
Total acquisition consideration | $ | 17,093 | ||||||
| | | | | ||||
| | | | | ||||
The stock consideration of $10.1 million was determined based on the closing price of the Company's common stock on September 16, 2014 ($10.45 per share). | ||||||||
The fair value of the assets acquired and liabilities assumed at the closing date of the Merger are summarized below (in thousands): | ||||||||
Cash and cash equivalents | $ | 29 | ||||||
Prepaid expenses | 3 | |||||||
Other current assets | 13 | |||||||
In-process research and development ("IPR&D") | 16,000 | |||||||
Goodwill | 1,057 | |||||||
Accrued liabilities | (9 | ) | ||||||
| | | | | ||||
Total net assets acquired | $ | 17,093 | ||||||
| | | | | ||||
| | | | | ||||
The fair value of IPR&D was determined using the multi-period excess earnings method of the income approach, which estimates the economic benefits of the IPR&D over multiple time periods by identifying the cash flows associated with the use of the asset, based on forecasts prepared by management, and deducting a periodic charge reflecting a fair return for the use of contributory assets. The forecasted cash flows were discounted based on a discount rate of 18.5%. The discount rate represents the Company's weighted average return on assets and was benchmarked against the internal rate of return and cost of capital of guideline publicly traded companies. The fair value of the IPR&D was capitalized as of the closing date of the Merger and is subsequently accounted for as an indefinite-lived intangible asset, tested for impairment at least annually, until completion or abandonment of the associated research and development activities. Once complete, amortization of the acquired IPR&D asset into earnings will commence. The Company estimates that the acquired IPR&D asset will have a useful life of less than 20 years after taking into consideration expected use of the asset, legal or regulatory provisions that may limit or extend the life of the asset, as well as the effects of obsolescence and other economic factors. | ||||||||
Goodwill, which represents the purchase price in excess of the fair value of net assets acquired, is not expected to be deductible for income tax purposes. This goodwill is reflective of the value derived from the expected acceleration of the Company's entry into the pulmonology market. | ||||||||
Pro Forma Financial Information (Unaudited) | ||||||||
The following pro forma financial information is based on the historical financial statements of the Company and presents the Company's results as if the Merger had occurred as of January 1, 2013 (in thousands): | ||||||||
Year Ended | ||||||||
December 31, | ||||||||
2014 | 2013 | |||||||
Revenue | $ | 38,190 | $ | 21,884 | ||||
| | | | | | | | |
| | | | | | | | |
Net loss | $ | (29,090 | ) | $ | (28,605 | ) | ||
| | | | | | | | |
| | | | | | | | |
The pro forma results present the combined historical results of operations with adjustments to reflect one-time charges including: | ||||||||
• | The reversal of costs related to transaction bonuses and other payments to employees and acquisition-related expenses directly related to the Merger of $2.2 million for the year ended December 31, 2014; and | |||||||
• | the elimination of interest expense related to Allegro indebtedness of $2.3 million and $4.5 million for the years ended December 31, 2014 and 2013, respectively. | |||||||
The pro forma information presented does not purport to present what the actual results would have been had the Merger actually occurred on January 1, 2013, nor is the information intended to project results for any future period. | ||||||||
Balance_Sheet_Components
Balance Sheet Components | 12 Months Ended | ||||||||||
Dec. 31, 2014 | |||||||||||
Balance Sheet Components | |||||||||||
Balance Sheet Components | |||||||||||
5. Balance Sheet Components | |||||||||||
Property and Equipment, Net | |||||||||||
Property and equipment consisted of the following (in thousands): | |||||||||||
Year Ended | |||||||||||
December 31, | |||||||||||
2014 | 2013 | ||||||||||
Leasehold improvements | $ | 788 | $ | 779 | |||||||
Laboratory equipment | 4,199 | 2,946 | |||||||||
Computer equipment | 875 | 645 | |||||||||
Software, including software developed for internal use | 1,353 | 901 | |||||||||
Furniture and fixtures | 197 | 189 | |||||||||
Construction-in-process | 739 | 307 | |||||||||
| | | | | | | | ||||
Total property and equipment, at cost | 8,151 | 5,767 | |||||||||
Accumulated depreciation and amortization | (3,990 | ) | (2,815 | ) | |||||||
| | | | | | | | ||||
Total property and equipment, net | $ | 4,161 | $ | 2,952 | |||||||
| | | | | | | | ||||
| | | | | | | | ||||
Depreciation and amortization expense was $1,175,000, $999,000 and $706,000 for the years ended December 31, 2014, 2013 and 2012, respectively, and was recorded in the statements of operations and comprehensive loss as follows (in thousands): | |||||||||||
Year Ended | |||||||||||
December 31, | |||||||||||
2014 | 2013 | 2012 | |||||||||
Cost of revenue | $ | 677 | $ | 593 | $ | 401 | |||||
Research and development | 187 | 179 | 184 | ||||||||
Selling and marketing | 101 | 54 | 46 | ||||||||
General and administrative | 210 | 173 | 75 | ||||||||
| | | | | | | | | | | |
Total depreciation and amortization expense | $ | 1,175 | $ | 999 | $ | 706 | |||||
| | | | | | | | | | | |
| | | | | | | | | | | |
Accrued Liabilities | |||||||||||
Accrued liabilities consisted of the following (in thousands): | |||||||||||
Year Ended | |||||||||||
December 31, | |||||||||||
2014 | 2013 | ||||||||||
Accrued compensation expenses | $ | 2,673 | $ | 1,962 | |||||||
Accrued Genzyme co-promotion fees | 3,309 | 4,915 | |||||||||
Accrued other | 1,869 | 717 | |||||||||
| | | | | | | | ||||
Total accrued liabilities | $ | 7,851 | $ | 7,594 | |||||||
| | | | | | | | ||||
| | | | | | | | ||||
Fair_Value_Measurements
Fair Value Measurements | 12 Months Ended | |||||||
Dec. 31, 2014 | ||||||||
Fair Value Measurements | ||||||||
Fair Value Measurements | ||||||||
6. Fair Value Measurements | ||||||||
The Company records its financial assets and liabilities at fair value. The carrying amounts of certain financial instruments of the Company, including cash and cash equivalents, prepaid expenses and other current assets, accounts payable and accrued liabilities, approximate fair value due to their relatively short maturities. The carrying value of debt approximates its fair value because the interest rate approximates market rates that the Company could obtain for debt with similar terms. The accounting guidance for fair value provides a framework for measuring fair value, clarifies the definition of fair value, and expands disclosures regarding fair value measurements. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The accounting guidance establishes a three-tiered hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value as follows: | ||||||||
• | Level I: Inputs which include quoted prices in active markets for identical assets and liabilities. | |||||||
• | Level II: Inputs other than Level I that are observable, either directly or indirectly, 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. | |||||||
• | Level III: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. | |||||||
The fair value of the Company's financial assets, which consist only of money market funds, was $33.2 million and $70.0 million as of December 31, 2014 and December 31, 2013, respectively, and are Level I assets as described above. | ||||||||
The Company has no Level III liabilities as of December 31, 2014 and 2013. The following table sets forth the changes in the fair value of the Company's Level III financial liabilities, which consisted of a preferred stock liability during 2013, which were measured on a recurring basis (in thousands): | ||||||||
December 31, | ||||||||
2014 | 2013 | |||||||
Beginning balance | $ | — | $ | 583 | ||||
Change in fair value of preferred stock liability recorded as other expense, net | — | 2,070 | ||||||
Settlement of preferred stock liability | — | (2,653 | ) | |||||
Fair value of preferred stock warrant liability | — | 175 | ||||||
Change in fair value of preferred stock warrant liability recorded as other expense, net | — | 86 | ||||||
Conversion of preferred stock warrant liability | — | (261 | ) | |||||
| | | | | | | | |
Ending balance | $ | — | $ | — | ||||
| | | | | | | | |
| | | | | | | | |
In November 2012, the Company recorded a preferred stock liability as investors received the right to purchase from the Company, on the same terms, additional shares of Series C convertible preferred stock, in a second tranche. As the investors held a majority of the board seats, the decision to complete the second tranche was deemed to be outside the control of the Company. The preferred stock liability was valued using the option-pricing method, which resulted in an initial fair value of $0.9 million for the Company's obligation to sell the convertible preferred stock. In June 2013, the Company settled the preferred stock liability upon completion of the sale of the second tranche of Series C convertible preferred stock. Immediately prior to settlement, the Company revalued the preferred stock liability to $2.7 million and recorded other expense of $2.1 million related to the change in value of the liability through that date. The preferred stock liability was valued using the option-pricing method with the following assumptions: 100% probability of success of the second tranche, fair value of Series C preferred stock of $2.39, a term of 0.003 years and expected volatility of 36.4%. | ||||||||
Commitments_and_Contingencies
Commitments and Contingencies | 12 Months Ended | ||||
Dec. 31, 2014 | |||||
Commitments and Contingencies | |||||
Commitments and Contingencies | |||||
7. Commitments and Contingencies | |||||
Operating Leases | |||||
The Company leases its headquarters and South San Francisco laboratory facilities under a non-cancelable lease agreement that expires March 31, 2016. The Company provided security deposits in the form of irrevocable standby letters of credit secured with restricted cash deposits at the Company's primary bank. The Company deposited $118,000 in restricted cash accounts as collateral for the lease which is included in restricted cash in the Company's consolidated balance sheets as of December 31, 2014 and 2013. | |||||
The Company also leases laboratory space in Austin, Texas. The lease expires on July 31, 2018. The Company provided a cash security deposit of $75,000, which is included in other assets in the Company's consolidated balance sheets as of December 31, 2014 and 2013. | |||||
Future minimum lease payments under non-cancelable operating leases as of December 31, 2014 are as follows (in thousands): | |||||
Year Ending December 31, | Amounts | ||||
2015 | $ | 989 | |||
2016 | 413 | ||||
2017 | 222 | ||||
2018 | 130 | ||||
Thereafter | — | ||||
| | | | | |
Total minimum lease payments | $ | 1,754 | |||
| | | | | |
| | | | | |
The Company recognizes rent expense on a straight-line basis over the non-cancelable lease period. Facilities rent expense was $852,000, $840,000 and $711,000 for the years ended December 31, 2014, 2013 and 2012, respectively. | |||||
Supplies Purchase Commitments | |||||
The Company had a non-cancelable purchase commitment with two suppliers to purchase a minimum quantity of supplies for approximately $715,000 at December 31, 2014, all of which is expected to be paid in early 2015. | |||||
Debt Obligations | |||||
See Note 8, Debt. | |||||
Contingencies | |||||
From time to time, the Company may be involved in legal proceedings arising in the ordinary course of business. The Company believes there is no litigation pending that could have, individually or in the aggregate, a material adverse effect on the financial position, results of operations or cash flows. | |||||
Debt
Debt | 12 Months Ended | |||||||
Dec. 31, 2014 | ||||||||
Debt | ||||||||
Debt | ||||||||
8. Debt | ||||||||
In June 2013, the Company entered into a loan and security agreement ("Original Loan") with a financial institution to fund its working capital and other general corporate needs. The Original Loan provided for term loans of up to $10.0 million in aggregate. The Company drew down $5.0 million in funds under the agreement in June 2013, and did not draw the remaining $5.0 million on or before the expiration date of March 31, 2014. The Company was required to repay the outstanding principal in 30 equal installments beginning 18 months after the date of the borrowing and was due in full in June 2017. The Original Loan had an interest rate of 6.06% per annum, carried prepayment penalties of 2.25% and 1.50% for prepayment within one and two years, respectively, and 0.75% thereafter. | ||||||||
In December 2014, the Company amended certain terms and conditions of the Original Loan ("Amended Loan"). The Amended Loan provides for term loans of up to $15.0 million in aggregate, in three tranches of $5.0 million each. The Company borrowed $5.0 million under the first tranche in December 2014 and used the funds for repayment of the $5.0 million in principal outstanding under the Original Loan, in a cashless transaction. In addition, the Company paid the accrued but unpaid interest of $14,000 due on the Original Loan and the related end-of-term payment of $110,000. The Amended Loan waived the prepayment premium of $75,000 under the Original Loan and reduced the end-of-term payment of $225,000 under the Original Loan to $110,000. The second $5.0 million tranche under the Amended Loan is available through December 31, 2015 and the Company may borrow the third $5.0 million tranche any time through June 30, 2016 after achieving the third tranche revenue milestone as defined in the Amended Loan. | ||||||||
The carrying value of the debt approximates its fair value because the interest rate approximates market rates that the Company could obtain for debt with similar terms. Under the Amended Loan borrowing, the Company is required to repay the outstanding principal in 24 equal installments beginning 24 months after the date of the borrowing and is due in full in December 2018. The first tranche of the Amended Loan bears interest at a rate of 5.00% per annum. The Amended Loan carries prepayment penalties of 2.00% and 1.00% for prepayment within one and two years, respectively, and no prepayment penalty thereafter. In connection with the Amended Loan, the Company paid approximately $45,000 in third-party fees. | ||||||||
The Amended Loan results in a debt modification under ASC 470-50, Modifications and Extinguishments, as the change in present value of the remaining cash flows associated with the Original Loan and Amended Loan are not substantial. | ||||||||
As of December 31, 2014 and 2013, the net debt obligation was as follows (in thousands): | ||||||||
December 31, | ||||||||
2014 | 2013 | |||||||
Debt and unpaid accrued end-of term payment | $ | 5,003 | $ | 5,042 | ||||
Unamorized note discount | (80 | ) | (143 | ) | ||||
| | | | | | | | |
Net debt obligation | $ | 4,923 | $ | 4,899 | ||||
| | | | | | | | |
| | | | | | | | |
Future principal payments under the Amended Loan are as follows (in thousands): | ||||||||
Year ending December 31: | ||||||||
2015 | $ | — | ||||||
2016 | — | |||||||
2017 | 2,437 | |||||||
2018 | 2,563 | |||||||
| | | | | ||||
Total | $ | 5,000 | ||||||
| | | | | ||||
| | | | | ||||
The obligation at December 31, 2014 includes an end-of-term payment of $237,500, representing 4.75% of the total outstanding principal balance, which accretes over the life of the loan as interest expense. As a result of the debt discount and the end-of-term payment, the effective interest rate for the loan differs from the contractual rate. | ||||||||
Interest expense on the debt was as follows (in thousands): | ||||||||
Year Ended | ||||||||
December 31, | ||||||||
2014 | 2013 | |||||||
Nominal interest | $ | 296 | $ | 158 | ||||
Amortization of debt discount | 62 | 33 | ||||||
End-of-term payment interest | 81 | 42 | ||||||
| | | | | | | | |
Total | $ | 439 | $ | 233 | ||||
| | | | | | | | |
| | | | | | | | |
Upon execution of the Original Loan, the Company issued the financial institution a warrant to purchase shares of Series C convertible preferred stock at $7.56 per share. At the time of issuance, the aggregate fair value of the warrant for the 24,801 shares exercisable under the warrant was $175,000. The fair value of the warrant was deducted from total proceeds, resulting in a debt discount to be amortized to interest expense over 48 months, through the maturity date of the Original Loan, using the effective interest rate method, and was recorded as a preferred stock warrant liability. The warrant was converted to a warrant to purchase the Company's common stock upon the completion of the Company's IPO. See Note 9. | ||||||||
The Company's obligations under the Amended Loan are secured by a security interest in substantially all of its assets, excluding its intellectual property and certain other assets. The Amended Loan contains customary conditions related to borrowing, events of default, and covenants, including covenants limiting the Company's ability to dispose of assets, undergo a change in control, merge with or acquire other entities, incur debt, incur liens, pay dividends or other distributions to holders of its capital stock, repurchase stock and make investments, in each case subject to certain exceptions. The Amended Loan also allows the lender to call the debt in the event there is a material adverse change in the Company's business or financial condition. The Company is required to be in compliance with a minimum liquidity or minimum revenue covenant. As of December 31, 2014, the Company was in compliance with the financial covenants. | ||||||||
Convertible_Preferred_Stock_Wa
Convertible Preferred Stock Warrant | 12 Months Ended |
Dec. 31, 2014 | |
Convertible Preferred Stock Warrant | |
Convertible Preferred Stock Warrant | |
9. Convertible Preferred Stock Warrant | |
In June 2013, in conjunction with the execution of the Original Loan, as discussed in Note 8, the Company issued to the lender a warrant to purchase up to 49,602 shares of Series C convertible preferred stock with an exercise price of $7.56 per share. Upon the draw-down of the $5.0 million term loan, the related warrant became exercisable for 24,801 shares. In November 2013, in connection with the Company's IPO, the warrant automatically became exercisable for 24,801 shares at an exercise price of $7.56 per share. The lender exercised the warrant with respect to 24,801 shares through a cashless exercise in March 2014, resulting in the issuance of 13,739 shares of the Company's common stock. | |
The fair value of the then currently exercisable portion of the warrant in the amount of $175,000 was recorded as a preferred stock warrant liability upon issuance and was subject to re-measurement at each reporting period up to the closing date of the IPO when the Series C preferred stock converted into common stock. The fair value of the warrant upon issuance was calculated using the Black-Scholes option-pricing model with the following assumptions: Series C preferred stock value of $2.40 per share, contractual term of 7.3 years, risk-free interest rate of 2.1%, expected volatility of 73.7%, and expected dividend yield of 0%. Just prior to the closing of the IPO, the fair value of the warrant was approximately $261,000, and was calculated using the Black-Scholes option-pricing model with the following assumptions: Series C preferred stock value of $13.14 per share, contractual term of 7.0 years, risk-free interest rate of 2.0%, expected volatility of 81.4%, and expected dividend yield of 0%. The change in the fair value of approximately $86,000 was reported as an expense for the year ended December 31, 2013 and was included in other income (expense), net, in the statements of operations and comprehensive loss. The warrant was converted into a warrant to purchase common stock upon the completion of the IPO in 2013, and was reclassified to additional paid- in-capital in the Company's consolidated balance sheet. | |
Convertible_Preferred_Stock
Convertible Preferred Stock | 12 Months Ended |
Dec. 31, 2014 | |
Convertible Preferred Stock | |
Convertible Preferred Stock | |
10. Convertible Preferred Stock | |
In November 2012, the Company recorded a preferred stock liability as the investors received the right to purchase from the Company, on the same terms, additional shares of Series C convertible preferred stock, in a second tranche. As the investors held a majority of the board seats, the decision to complete the second tranche was deemed to be outside the control of the Company. The preferred stock liability was valued using the option-pricing method with the following assumptions: 100% probability of success of the second tranche, fair value of Series C preferred stock of $1.78, a term of 0.67 years and expected volatility of 44%. This resulted in an initial fair value of $0.9 million for the Company's obligation to sell the convertible preferred stock. At December 31, 2012, the Company revalued the preferred stock liability to $0.6 million, and recorded the $0.3 million valuation decrease to other income (expense), net, in the Company's statements of operations and comprehensive loss. In June 2013, the Company revalued the preferred stock liability to $2.7 million and recorded the $2.1 million valuation increase to other income (expense), net, in the Company's consolidated statements of operations and comprehensive loss. In June 2013, the $2.7 million liability was settled upon the issuance of the second tranche of Series C convertible preferred stock and was reclassified to additional paid-in-capital in the Company's consolidated balance sheets. | |
On November 4, 2013, the Company completed its IPO. In connection with the IPO, the Company's 59,989,268 outstanding shares of convertible preferred stock were automatically converted into 14,997,312 shares of common stock. | |
Stockholders_Equity_Deficit
Stockholders' Equity (Deficit) | 12 Months Ended | |||||||
Dec. 31, 2014 | ||||||||
Stockholders' Equity | ||||||||
Stockholders' Equity | ||||||||
11. Stockholders' Equity | ||||||||
Common Stock | ||||||||
The Company's Restated Certificate of Incorporation authorizes the Company to issue 125,000,000 shares of common stock with a par value of $0.001 per share. The holder of each share of common stock shall have one vote for each share of stock. The common stockholders are also entitled to receive dividends whenever funds and assets are legally available and when declared by the Board of Directors, subject to the prior rights of holders of all series of convertible preferred stock outstanding. No dividends have been declared as of December 31, 2014. | ||||||||
As of December 31, 2014 and 2013, the Company had reserved shares of common stock for issuance as follows: | ||||||||
December 31, | December 31, | |||||||
2014 | 2013 | |||||||
Options issued and outstanding | 3,249,469 | 2,359,287 | ||||||
Options available for grant under stock option plans | 1,341,252 | 1,787,802 | ||||||
Common stock warrants issued and outstanding | — | 24,801 | ||||||
| | | | | | | | |
Total | 4,590,721 | 4,171,890 | ||||||
| | | | | | | | |
| | | | | | | | |
Preferred Stock | ||||||||
The Company's Restated Certificate of Incorporation authorizes the Company to issue 5,000,000 shares of preferred stock with a par value of $0.001 per share. No shares were issued and outstanding at December 31, 2014 or 2013. | ||||||||
Stock_Incentive_Plans
Stock Incentive Plans | 12 Months Ended | ||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||
Stock Incentive Plans | |||||||||||||||||
Stock Incentive Plans | |||||||||||||||||
12. Stock Incentive Plans | |||||||||||||||||
Stock Option Plans | |||||||||||||||||
In February 15, 2008, the Company adopted the 2008 Stock Plan (the "2008 Plan"). The 2008 Plan provides for the granting of options to purchase common stock and common stock to employees, directors and consultants of the Company. The Company may grant incentive stock options ("ISOs"), non-statutory stock options ("NSOs") or restricted stock under the 2008 Plan. ISOs may only be granted to Company employees (including directors who are also considered employees). NSOs and restricted stock may be granted to Company employees, directors and consultants. Options may be granted for terms of up to ten years from the date of grant, as determined by the Board of Directors, provided however, that with respect to an ISO granted to a person who owns stock representing more than 10% of the voting power of all classes of stock of the Company, the term shall be for no more than five years from the date of grant. The exercise price of options granted must be at a price no less than 100% of the estimated fair value of the shares on the date of grant, as determined by the Board of Directors, provided however, that with respect to an ISO granted to an employee who at the time of grant of such option owns stock representing more than 10% of the voting power of all classes of stock of the Company, the exercise price shall not be less than 110% of the estimated fair value of the shares on the date of grant. Options granted to newly hired employees generally vest over four years (generally 25% after one year and monthly thereafter). Options granted to employees as part of annual bonus compensation are generally fully vested at the grant date. | |||||||||||||||||
On October 2, 2013, the Company adopted the 2013 Stock Incentive Plan (the "2013 Plan"). The 2013 Plan was subsequently approved by the Company's stockholders and became effective on November 4, 2013, immediately before the closing of the Company's IPO. Following the effectiveness of the 2013 Plan, no additional options will be granted under the 2008 Plan. An aggregate of 1,700,000 shares were initially reserved for issuance under the 2013 Plan. In addition, to the extent that any awards outstanding or subject to vesting restrictions under the 2008 Plan are subsequently forfeited or terminated for any reason before being exercised or settled, the shares of common stock reserved for issuance pursuant to such awards as of the closing of the IPO will become available for issuance under the 2013 Plan. The remaining shares available for grant under the 2008 Plan became available for issuance under the 2013 Plan upon the closing of the IPO. On the first day of each year from 2014 to 2023, the 2013 Plan authorizes an annual increase of the lesser of 4% of outstanding shares on the last day of the immediately preceding fiscal year or a lesser amount as determined by the Company's Board of Directors. As of December 31, 2014, 1,341,252 shares were available for future issuance under the 2013 Plan. | |||||||||||||||||
Pursuant to the 2013 Plan, stock options, restricted shares, stock units, including restricted stock units and stock appreciation rights may be granted to employees, consultants, and outside directors of the Company. Options granted may be either ISOs or NSOs. | |||||||||||||||||
Stock options are governed by stock option agreements between the Company and recipients of stock options. ISOs and NSOs may be granted under the 2013 Plan at an exercise price of not less than 100% of the fair market value of the common stock on the date of grant, determined by the Compensation Committee of the Board of Directors. Options become exercisable and expire as determined by the Compensation Committee, provided that the term of ISOs may not exceed ten years from the date of grant. Stock option agreements may provide for accelerated exercisability in the event of an optionee's death, disability, or retirement or other events. | |||||||||||||||||
Any outside director who was not previously an employee and who first joins the Company's Board of Directors on or after the effective date of the 2013 Plan will be automatically granted an initial NSO to purchase 35,000 shares of common stock upon first becoming a member of the Board of Directors. Twenty-five percent of the shares subject to the initial option will vest and become exercisable on the first anniversary of the date of grant. The balance (i.e. the remaining 75%) will vest and become exercisable over three years in equal monthly installments. On the first business day after each regularly scheduled annual meeting of stockholders, each outside director who was not elected to the Board of Directors for the first time at such meeting and who will continue serving as a member of the Board of Directors thereafter will be automatically granted an option to purchase 10,000 shares of common stock, provided that the outside director has served on the Board of Directors for at least six months. Each annual option will vest and become exercisable on the first anniversary of the date of grant, or immediately prior to the next regular annual meeting of the Company's stockholders following the date of grant if the meeting occurs prior to the first anniversary date. The options granted to outside directors will have a per share exercise price equal to 100% of the fair market value of the underlying shares on the date of grant and will become fully vested in the event of a change of control. In addition, such options will terminate on the earlier of (i) the day before the 10th anniversary of the date of grant or (ii) the date 12 months after the termination of the outside director's service for any reason. | |||||||||||||||||
The following table summarizes activity under the Company's stock option plans (aggregate intrinsic value in thousands): | |||||||||||||||||
Shares | Stock Options | Weighted | Weighted Average | Aggregate | |||||||||||||
Available | Outstanding | Average | Remaining | Intrinsic | |||||||||||||
for Grant | Exercise Price | Contractual Life | Value | ||||||||||||||
(Years) | |||||||||||||||||
Balance—December 31, 2011 | 474,961 | 1,429,737 | $ | 1.55 | 8.22 | $ | 1,221 | ||||||||||
Additional options authorized | 743,100 | — | |||||||||||||||
Granted | (931,944 | ) | 931,944 | 2.78 | |||||||||||||
Canceled | 61,269 | (61,269 | ) | 1.97 | |||||||||||||
Exercised | — | (72,743 | ) | 1.05 | |||||||||||||
| | | | | | | | | | | | | | | | | |
Balance—December 31, 2012 | 347,386 | 2,227,669 | $ | 2.06 | 8.17 | $ | 4,311 | ||||||||||
Additional options authorized | 1,950,000 | — | |||||||||||||||
Granted | (695,029 | ) | 695,029 | 5.32 | |||||||||||||
Canceled | 185,445 | (185,445 | ) | 2.69 | |||||||||||||
Exercised | — | (377,966 | ) | 1.46 | |||||||||||||
| | | | | | | | | | | | | | | | | |
Balance—December 31, 2013 | 1,787,802 | 2,359,287 | $ | 3.07 | 7.84 | $ | 26,964 | ||||||||||
Additional options authorized | 845,732 | — | |||||||||||||||
Granted | (1,488,492 | ) | 1,488,492 | 13.38 | |||||||||||||
Canceled | 196,210 | (196,210 | ) | 9.37 | |||||||||||||
Exercised | — | (402,100 | ) | 1.68 | |||||||||||||
| | | | | | | | | | | | | | | | | |
Balance—December 31, 2014 | 1,341,252 | 3,249,469 | $ | 7.59 | 7.88 | $ | 12,400 | ||||||||||
| | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | |
Options vested and exercisable—December 31, 2014 | 1,370,944 | $ | 2.92 | 6.44 | $ | 9,287 | |||||||||||
Options vested and expected to vest—December 31, 2014 | 3,092,476 | $ | 7.32 | 7.81 | $ | 12,295 | |||||||||||
The aggregate intrinsic value was calculated as the difference between the exercise price of the options to purchase common stock and the fair market value of the Company's common stock, which was $9.66 per share as of December 31, 2014 and $14.50 per share as of December 31, 2013. | |||||||||||||||||
The weighted average fair value of options to purchase common stock granted was $9.08, $4.19 and $1.95 for the years ended December 31, 2014, 2013 and 2012, respectively. | |||||||||||||||||
The weighted average fair value of stock options vested was $3.07, $2.12 and $1.40 per share for the years ended December 31, 2014, 2013 and 2012, respectively. The aggregate estimated grant date fair value of employee options to purchase common stock vested during the years ended December 31, 2014 and 2013 was $1.6 million and $1.3 million, respectively. | |||||||||||||||||
The weighted-average fair value of stock options exercised was $1.18 and $0.97 for the years ended December 31, 2014 and 2013, respectively. The intrinsic value of stock options exercised was $3.2 million, $4.9 million and $0.2 million for the years ended December 31, 2014, 2013 and 2012, respectively. | |||||||||||||||||
Stock-based Compensation | |||||||||||||||||
The following table summarizes stock-based compensation expense related to stock options for the years ended December 31, 2014, 2013 and 2012, and are included in the consolidated statements of operations and comprehensive loss as follows (in thousands): | |||||||||||||||||
Year Ended December 31, | |||||||||||||||||
2014 | 2013 | 2012 | |||||||||||||||
Cost of revenue | $ | 51 | $ | 34 | $ | 26 | |||||||||||
Research and development | 790 | 250 | 131 | ||||||||||||||
Selling and marketing | 707 | 169 | 111 | ||||||||||||||
General and administrative | 2,000 | 794 | 407 | ||||||||||||||
| | | | | | | | | | | |||||||
Total stock-based compensation expense | $ | 3,548 | $ | 1,247 | $ | 675 | |||||||||||
| | | | | | | | | | | |||||||
| | | | | | | | | | | |||||||
As of December 31, 2014, the Company had $9.9 million of unrecognized compensation expense related to unvested stock options, which is expected to be recognized over an estimated weighted-average period of 3.0 years. | |||||||||||||||||
The estimated grant-date fair value of employee stock options was calculated using the Black-Scholes option-pricing model, based on the following assumptions: | |||||||||||||||||
Year Ended December 31, | |||||||||||||||||
2014 | 2013 | 2012 | |||||||||||||||
Weighted-average volatility | 70.19 - 78.54% | 80.42 - 81.41% | 82.07 - 84.33% | ||||||||||||||
Weighted-average expected term (years) | 5.50 - 6.08 | 5.00 - 6.08 | 5.00 - 6.08 | ||||||||||||||
Risk-free interest rate | 1.66 - 2.04% | 0.88 - 2.11% | 0.65 - 1.19% | ||||||||||||||
Expected dividend yield | — | — | — | ||||||||||||||
The estimated grant-date fair value of non-employee stock options was calculated using the Black-Scholes option-pricing model, based on the following assumptions: | |||||||||||||||||
Year Ended December 31, | |||||||||||||||||
2014 | 2013 | 2012 | |||||||||||||||
Weighted-average volatility | 73.20 - 74.48% | 77.86 - 78.14% | 81.14 - 82.11% | ||||||||||||||
Weighted-average expected term (years) | 8.75 - 10.00 | 7.72 - 9.75 | 8.23 - 9.93 | ||||||||||||||
Risk-free interest rate | 2.09 - 2.20% | 2.59 - 2.99% | 1.43 - 1.77% | ||||||||||||||
Expected dividend yield | — | — | — | ||||||||||||||
Equity-based Compensation | |||||||||||||||||
In February 2013, the Company's Board of Directors authorized the grant of 100,498 fully vested stock options at a fair value of $2.59, determined using the Black-Scholes option-pricing valuation model, resulting in a $259,000 expense in the year ended December 31, 2012. Upon issuance of the options, the accrued liability was reclassified into additional paid-in capital. For the years ended December 31, 2014 and 2013, the Company paid executive bonuses only in the form of cash. | |||||||||||||||||
Genzyme_Copromotion_Agreement
Genzyme Co-promotion Agreement | 12 Months Ended |
Dec. 31, 2014 | |
Genzyme Co-promotion Agreement | |
Genzyme Co-promotion Agreement | |
13. Genzyme Co-Promotion Agreement | |
In January 2012, the Company and Genzyme Corporation ("Genzyme") executed a co-promotion agreement for the co-exclusive rights and license to promote and market the Company's Afirma thyroid diagnostic solution in the United States and in 40 named countries. In exchange, the Company received a $10.0 million upfront co-promotion fee from Genzyme in February 2012. Under the terms of the agreement, Genzyme will receive a percentage of U.S. cash receipts that the Company has received related to Afirma as co-promotion fees. The percentage was 50% in 2012, 40% from January 2013 through February 2014, and 32% beginning in February 2014. Genzyme's obligation to also spend up to $500,000 for qualifying clinical development activities in countries that require additional testing for approval expired in July 2014. | |
On August 12, 2014, the Company signed a binding Letter of Agreement with Genzyme to amend terms of the co-promotion agreement. On November 7, 2014, the Company signed an Amended and Restated U.S. Co-Promotion Agreement ("Amended Agreement") with Genzyme. Under the Amended Agreement, the co-promotion fees Genzyme will receive as a percentage of U.S. cash receipts were reduced from 32% to 15% beginning January 1, 2015. Through August 11, 2014, the Company amortized the $10.0 million upfront co-promotion fee over a four-year period, which was management's best estimate of the life of the agreement, in part because after that period either party could have terminated the agreement without penalty. Effective August 12, 2014, the Company extended the amortization period from January 2016 to June 2016, the modified earliest period either party could terminate the agreement without penalty. The Company accounted for the change in accounting estimate prospectively. Either party may terminate the agreement with six months prior notice, however, under the Amended Agreement, neither party can terminate the agreement for convenience prior to June 30, 2016. The agreement with Genzyme expires in 2027. | |
On November 7, 2014, the Company signed a binding Letter of Agreement (the "LOA") with Genzyme to negotiate a potential co-promotion agreement to promote Afirma GEC in countries other than the United States. The LOA provided an exclusive negotiation period to attempt to negotiate in good faith until December 12, 2014 a mutually agreeable co-promotion agreement ("Ex-U.S. Co-Promotion Agreement") pursuant to which the companies could co-promote the test in six initial countries. During such exclusive negotiation period, both parties were prohibited from negotiating with any third party with respect to those six countries. On December 12, 2014 the parties amended the LOA to extend the exclusive negotiation period from December 12, 2014 to January 31, 2015. During the extended period, the terms of the original co-promotion agreement with respect to countries outside the U.S. would remain in effect, including the payment to Genzyme of 32% of net revenues received by the Company on the test in countries outside the U.S. On January 30, 2015 the parties further amended the LOA to extend the exclusive negotiation period to February 14, 2015. | |
On February 13, 2015, the Company signed an Ex-U.S. Co-Promotion Agreement with Genzyme for the promotion of the Afirma GEC test with exclusivity in five countries outside the United States initially and in other countries agreed to from time to time. See Note 18, Subsequent Event. | |
The Company incurred $12.0 million, $8.6 million and $5.5 million in co-promotion expense in the years ended December 31, 2014, 2013 and 2012, respectively, which is included in selling and marketing expenses in the consolidated statements of operations and comprehensive loss. The Company's outstanding obligation to Genzyme totaled $6.0 million and $6.7 million at December 31, 2014 and December 31, 2013, respectively. Of the $6.0 million obligation at December 31, 2014, $2.7 million is included in accounts payable and $3.3 million is included in accrued liabilities in the Company's consolidated balance sheets. Of the $6.7 million obligation at December 31, 2013, $1.8 million is included in accounts payable and $4.9 million is included in accrued liabilities in the Company's consolidated balance sheets. | |
The Company amortized $2.3 million, $2.5 million and $2.4 million of the $10.0 million up-front co-promotion fee in the years ended December 31, 2014, 2013 and 2012, respectively, which is reflected as a reduction to selling and marketing expenses in the consolidated statements of operations and comprehensive loss. | |
Thyroid_Cytopathology_Partners
Thyroid Cytopathology Partners | 12 Months Ended |
Dec. 31, 2014 | |
Thyroid Cytopathology Partners. | |
Thyroid Cytopathology Partners | |
14. Thyroid Cytopathology Partners | |
In 2010, the Company entered into an arrangement with Pathology Resource Consultants, P.A. ("PRC") to set up and manage a specialized pathology practice to provide testing services to the Company. There is no direct monetary compensation from the Company to PRC as a result of this arrangement. The Company's service agreement is with the specialized pathology practice, Thyroid Cytopathology Partners, ("TCP"), and is effective through December 31, 2015, and thereafter automatically renews every year unless either party provides notice of intent not to renew at least 12 months prior to the end of the then-current term. Under the service agreement, the Company pays TCP based on a fixed price per test schedule, which is reviewed periodically for changes in market pricing. Subsequent to December 2012, an amendment to the service agreement allows TCP to use a portion of the Company's facility in Austin, Texas. The Company does not have an ownership interest in or provide any form of financial or other support to TCP. | |
The Company has concluded that TCP represents a variable interest entity and that the Company is not the primary beneficiary as it does not have the ability to direct the activities that most significantly impact TCP's economic performance. Therefore, the Company does not consolidate TCP. All amounts paid to TCP under the service agreement are expensed as incurred and included in cost of revenue in the consolidated statements of operations and comprehensive loss. The Company incurred $4.0 million, $3.2 million and $1.8 million in the years ended December 31, 2014, 2013 and 2012, respectively, in cytopathology testing and evaluation services expenses with TCP. The Company's outstanding obligations to TCP for cytopathology testing services were $1.1 million and $0.6 million as of December 31, 2014 and 2013, respectively, and are included in accounts payable in the Company's consolidated balance sheets. | |
TCP reimburses the Company for a proportionate share of the Company's rent and related operating expense costs for the leased facility. TCP's portion of rent and related operating expense costs for the shared space at the Austin, Texas facility was $86,000 and $49,000 for the years ended December 31, 2014 and 2013. TCP reimbursed the Company $59,000 in 2013 and the resulting excess payment of $10,000 was included in accounts payable in the Company's consolidated balance sheets at December 31, 2013. | |
Income_Taxes
Income Taxes | 12 Months Ended | ||||||||||
Dec. 31, 2014 | |||||||||||
Income Taxes | |||||||||||
Income Taxes | |||||||||||
15. Income Taxes | |||||||||||
The Company generated a pretax loss of $29.4 million, $25.6 million and $18.6 million in the United States for the years ended December 31, 2014, 2013 and 2012, respectively. Since inception, the Company has not generated any pretax income or loss outside of the United States. The Company did not record a provision or benefit for income taxes during the years ended December 31, 2014, 2013 and 2012. | |||||||||||
The Company follows FASB ASC No. 740, Income Taxes for the Computation and Presentation of its Tax Provision. The following table presents a reconciliation of the tax expense computed at the statutory federal rate and the Company's tax expense for the period presented (in thousands): | |||||||||||
Year Ended December, 31, | |||||||||||
2014 | 2013 | 2012 | |||||||||
U.S. federal taxes at statutory rate | $ | (9,987 | ) | $ | (8,697 | ) | $ | (6,341 | ) | ||
State tax (net of federal benefit) | 5 | 11 | (1,074 | ) | |||||||
Permanent differences | 64 | 790 | (23 | ) | |||||||
Incentive stock options | 672 | 355 | 284 | ||||||||
Tax credits | (461 | ) | (502 | ) | (113 | ) | |||||
Change in valuation allowance | 9,707 | 8,043 | 7,267 | ||||||||
| | | | | | | | | | | |
Total | $ | — | $ | — | $ | — | |||||
| | | | | | | | | | | |
| | | | | | | | | | | |
Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company's deferred tax assets and liabilities are as follows (in thousands): | |||||||||||
Year Ended December 31, | |||||||||||
2014 | 2013 | 2012 | |||||||||
Current deferred tax assets: | |||||||||||
Genzyme co-promotion agreement | $ | 793 | $ | 1,005 | $ | 1,001 | |||||
Accruals and deferred rent | 1,819 | 599 | 148 | ||||||||
| | | | | | | | | | | |
Gross deferred tax assets | 2,612 | 1,604 | 1,149 | ||||||||
Valuation allowance | (2,312 | ) | (1,603 | ) | (1,145 | ) | |||||
| | | | | | | | | | | |
Net deferred tax assets | 300 | 1 | 4 | ||||||||
| | | | | | | | | | | |
Non-current deferred tax assets: | |||||||||||
Net operating loss carryforwards | 41,971 | 28,569 | 20,536 | ||||||||
Research and development credits | 1,916 | 1,455 | 954 | ||||||||
Stock-based compensation | 826 | 313 | 154 | ||||||||
Genzyme co-promotion agreement | 202 | 787 | 2,048 | ||||||||
Accruals, deferred rent and other | 1,562 | 106 | 9 | ||||||||
| | | | | | | | | | | |
Gross deferred tax assets | 46,477 | 31,230 | 23,701 | ||||||||
Valuation allowance | (41,127 | ) | (31,216 | ) | (23,622 | ) | |||||
| | | | | | | | | | | |
Net deferred tax assets | 5,350 | 14 | 79 | ||||||||
| | | | | | | | | | | |
Deferred tax liabilities: | |||||||||||
Property and equipment | (60 | ) | (15 | ) | (83 | ) | |||||
In-process research and development | (5,590 | ) | — | — | |||||||
| | | | | | | | | | | |
Gross deferred tax liabilities | (5,650 | ) | (15 | ) | (83 | ) | |||||
| | | | | | | | | | | |
Net non-current deferred tax liabilities | (300 | ) | (1 | ) | (4 | ) | |||||
| | | | | | | | | | | |
Total deferred tax assets | $ | — | $ | — | $ | — | |||||
| | | | | | | | | | | |
| | | | | | | | | | | |
The Company has established a full valuation allowance against its net deferred tax assets due to the uncertainty surrounding realization of such assets. The valuation allowance increased $10.6 million and $8.1 million during the years ended December 31, 2014 and 2013, respectively. | |||||||||||
As of December 31, 2014, the Company had net operating loss carryforwards of approximately $113.6 million and $60.6 million available to reduce future taxable income, if any, for federal and state income tax purposes, respectively. Of these amounts, $0.2 million represent federal and state deductions from stock-based compensation, which will be recorded as an adjustment to additional paid-in capital when they reduce tax payable. The U.S. federal net operating loss carryforwards will begin to expire in 2026 while for state purposes, the net operating losses will begin to expire in 2018. | |||||||||||
As of December 31, 2014, the Company had net credit carryforwards of approximately $2.2 million and $1.6 million available to reduce future taxable income, if any, for federal and state income tax purposes, respectively. The federal credit carryforwards begin to expire in 2028. California credits have no expiration date. | |||||||||||
The Internal Revenue Code of 1986, as amended, imposes restrictions on the utilization of net operating losses and tax credits in the event of an "ownership change" of a corporation. Accordingly, a company's ability to use net operating losses and tax credits may be limited as prescribed under Internal Revenue Code Section 382 and 383 ("IRC Section 382"). Events which may cause limitations in the amount of the net operating losses or tax credits that the Company may use in any one year include, but are not limited to, a cumulative ownership change of more than 50% over a three-year period. Utilization of the federal and state net operating losses may be subject to substantial annual limitation due to the ownership change limitations provided by the IRC Section 382 rules and similar state provisions. In the event the Company has any changes in ownership, net operating losses and research and development credit carryovers could be limited and may expire unutilized. | |||||||||||
Uncertain Tax Positions | |||||||||||
As of December 31, 2014, the Company had unrecognized tax benefits of $1.6 million, none of which would currently affect the Company's effective tax rate if recognized due to the Company's deferred tax assets being fully offset by a valuation allowance. The Company does not anticipate that the amount of unrecognized tax benefits relating to tax positions existing at December 31, 2014 will significantly increase or decrease within the next 12 months. | |||||||||||
A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows (in thousands): | |||||||||||
Year Ended | |||||||||||
December 31, | |||||||||||
2014 | 2013 | 2012 | |||||||||
Unrecognized tax benefits, beginning of period | $ | 727 | $ | 481 | $ | 341 | |||||
Gross increases—tax position in prior period | 548 | 68 | 67 | ||||||||
Gross increases—current period tax positions | 296 | 178 | 73 | ||||||||
| | | | | | | | | | | |
Unrecognized tax benefits, end of period | $ | 1,571 | $ | 727 | $ | 481 | |||||
| | | | | | | | | | | |
| | | | | | | | | | | |
It is the Company's policy to include penalties and interest expense related to income taxes as a component of other income (expense), net, and interest expense, respectively, as necessary. There was no interest expense or penalties related to unrecognized tax benefits recorded through December 31, 2014. | |||||||||||
The Company's major tax jurisdictions are the United States and California. All of the Company's tax years will remain open for examination by the Federal and state tax authorities for three and four years, respectively, from the date of utilization of the net operating loss or research and development credit. The Company does not have any tax audits pending. | |||||||||||
401k_Plan
401(k) Plan | 12 Months Ended |
Dec. 31, 2014 | |
401(k) Plan | |
401(k) Plan | |
16. 401(k) Plan | |
The Company sponsors a 401(k) defined contribution plan covering all employees. There were no employer contributions to the plan in the years ended December 31, 2014 and 2013. | |
Selected_Quarterly_Financial_D
Selected Quarterly Financial Data (Unaudited) | 12 Months Ended | |||||||||||||
Dec. 31, 2014 | ||||||||||||||
Selected Quarterly Financial Data (Unaudited) | ||||||||||||||
Selected Quarterly Financial Data (Unaudited) | ||||||||||||||
17. Selected Quarterly Financial Data (Unaudited) | ||||||||||||||
The following table presents selected unaudited consolidated financial data for each of the eight quarters in the two-year period ended December 31, 2014. The Company believes this information reflects all recurring adjustments necessary to fairly present this information when read in conjunction with the Company's financial statements and the related notes. Net loss per common share, basic and diluted, for the four quarters of each fiscal year may not sum to the total for the fiscal year because of the different number of shares outstanding during each period. The results of operations for any quarter are not necessarily indicative of the results to be expected for any future period. | ||||||||||||||
Quarter Ended | March 31 | June 30 | September 30 | December 31 | ||||||||||
(In thousands, except share and per share data) | ||||||||||||||
2014:00:00 | ||||||||||||||
Total revenues | $ | 7,476 | $ | 8,677 | $ | 9,838 | $ | 12,199 | ||||||
Net loss | (6,674 | ) | (6,655 | ) | (7,902 | ) | (8,142 | ) | ||||||
Net loss per common share, basic and diluted | (0.32 | ) | (0.31 | ) | (0.37 | ) | (0.36 | ) | ||||||
Shares used to compute net loss per common share, basic and diluted | 21,148,342 | 21,237,196 | 21,648,660 | 22,508,250 | ||||||||||
2013:00:00 | ||||||||||||||
Total revenues | $ | 4,384 | $ | 5,068 | $ | 5,594 | $ | 6,838 | ||||||
Net loss | (6,895 | ) | (6,490 | ) | (6,303 | ) | (5,892 | ) | ||||||
Net loss per common share, basic and diluted | (9.04 | ) | (7.53 | ) | (6.59 | ) | (0.42 | ) | ||||||
Shares used to compute net loss per common share, basic and diluted | 763,021 | 861,839 | 955,890 | 13,944,239 | ||||||||||
Subsequent_Event
Subsequent Event | 12 Months Ended |
Dec. 31, 2014 | |
Subsequent Event. | |
Subsequent Event | |
18. Subsequent Event (Unaudited) | |
On February 13, 2015, the Company signed an Ex-U.S. Co-Promotion Agreement with Genzyme for the promotion of the Afirma GEC test with exclusivity in five countries outside the United States initially and in other countries agreed to from time to time. The term of the agreement is January 1, 2015 and continuing until December 31, 2019 with extension of the agreement possible upon agreement of the parties. Country specific terms have been established under this agreement for Brazil and Singapore and a right of first negotiation has been established for Canada, the Netherlands and Italy. The Company will pay Genzyme 25% of net revenue in Brazil and Singapore over a five-year period commencing January 1, 2015. Beginning in the fourth year of the agreement, if the Company terminates the agreement for convenience, the Company may be required to pay a termination fee contingent on the number of GEC billable results generated. | |
Summary_of_Significant_Account1
Summary of Significant Accounting Policies (Policies) | 12 Months Ended | ||||||||||
Dec. 31, 2014 | |||||||||||
Summary of Significant Accounting Policies | |||||||||||
Basis of Presentation | Basis of Presentation | ||||||||||
The Company's consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States ("GAAP"). The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary. All intercompany accounts and transactions have been eliminated in consolidation. | |||||||||||
Use of Estimates | Use of Estimates | ||||||||||
The preparation of the consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Significant items subject to such estimates include: revenue recognition; contractual allowances; allowance for doubtful accounts; the useful lives of property and equipment; the recoverability of long-lived assets; the estimation of the fair value of intangible assets; the determination of fair value of the Company's common stock prior to the Company's IPO; stock options; preferred stock liability; income tax uncertainties, including a valuation allowance for deferred tax assets; and contingencies. The Company bases these estimates on historical and anticipated results, trends, and various other assumptions that the Company believes are reasonable under the circumstances, including assumptions as to future events. These estimates form the basis for making judgments about the carrying values of assets and liabilities and recorded revenue and expenses that are not readily apparent from other sources. Actual results could differ from those estimates and assumptions. | |||||||||||
Liquidity | Liquidity | ||||||||||
The Company has incurred net losses since its inception and expects to incur additional losses in 2015 and in future years. As of December 31, 2014, the Company had an accumulated deficit of $115.0 million. The Company may never achieve revenue sufficient to offset its expenses. The Company believes its cash and cash equivalents of $35.0 million as of December 31, 2014 and its revenue from the sale of Afirma in 2015 will be sufficient to meet its anticipated cash requirements for at least the next 12 months. | |||||||||||
If the Company is not able to generate revenue to finance its cash requirements, the Company will need to finance future cash needs primarily through public or private equity offerings, debt financings, borrowings or strategic collaborations or licensing arrangements. If the Company is not able to secure additional funding when needed, on acceptable terms, it may have to delay, reduce the scope of or eliminate one or more research and development programs or selling and marketing initiatives which may have a material adverse effect on the Company's business, results of operations, financial condition and/or its ability to fund its scheduled obligations on a timely basis or at all. | |||||||||||
Concentrations of Credit Risk and Other Risks and Uncertainties | Concentrations of Credit Risk and Other Risks and Uncertainties | ||||||||||
The Company's cash and cash equivalents are deposited with one major financial institution in the United States, as required by the loan and security agreement discussed in Note 8. Deposits in this institution may exceed the amount of insurance provided on such deposits. The Company has not experienced any losses on its deposits of cash and cash equivalents. | |||||||||||
Several of the components of the Company's sample collection kit and test reagents are obtained from single-source suppliers. If these single-source suppliers fail to satisfy the Company's requirements on a timely basis, it could suffer delays in being able to deliver its diagnostic solution, a possible loss of revenue, or incur higher costs, any of which could adversely affect its operating results. | |||||||||||
The Company is also subject to credit risk from its accounts receivable related to its sales of Afirma. The Company generally does not perform evaluations of customers' financial condition and generally does not require collateral. | |||||||||||
Through December 31, 2014, all of the Company's revenue have been derived from the sale of Afirma. The Company's solution to date has been delivered primarily to physicians in the United States. The Company's third-party payers in excess of 10% of revenue and their related revenue as a percentage of total revenue were as follows: | |||||||||||
Year Ended | |||||||||||
December 31, | |||||||||||
2014 | 2013 | 2012 | |||||||||
Medicare | 26 | % | 32 | % | 34 | % | |||||
Aetna | 11 | % | 9 | % | 13 | % | |||||
United Healthcare | 18 | % | 18 | % | 12 | % | |||||
| | | | | | | | | | | |
55 | % | 59 | % | 59 | % | ||||||
| | | | | | | | | | | |
| | | | | | | | | | | |
As the number of payers reimbursing for Afirma increases, the percentage of revenue derived from Medicare and other significant third-party payers has changed and will continue to change as a percentage of total revenue. | |||||||||||
The Company's significant third-party payers and their related accounts receivable balance at December 31, 2014 and 2013 as a percentage of total accounts receivable are as follows: | |||||||||||
December 31, | |||||||||||
2014 | 2013 | ||||||||||
Medicare | 64 | % | 78 | % | |||||||
Aetna | 12 | % | — | ||||||||
United Healthcare | 14 | % | 3 | % | |||||||
No other third-party payer represented more than 10% of the Company's accounts receivable balances for these periods. | |||||||||||
Cash Equivalents | Cash Equivalents | ||||||||||
Cash equivalents consist of short-term, highly liquid investments with original maturities of three months or less from the date of purchase. Cash equivalents consist primarily of amounts invested in a money market account primarily consisting of U.S. Treasury reserves. | |||||||||||
Restricted Cash | Restricted Cash | ||||||||||
The Company reserved $70,000 in cash as of December 31, 2014 to cover liabilities associated with the acquisition of Allegro as discussed in Note 4. This restricted cash is included in current assets on the Company's consolidated balance sheet. | |||||||||||
The Company had long-term deposits of $118,000 as of December 31, 2014 and 2013, restricted from withdrawal and held by a bank in the form of collateral for letters of credit. The balance for each period consists of a letter of credit totaling $118,000 held as security for the lease of the Company's office space in South San Francisco, California. This restricted cash is included in long-term assets on the Company's consolidated balance sheets. | |||||||||||
Allowance for Doubtful Accounts | Allowance for Doubtful Accounts | ||||||||||
The Company estimates an allowance for doubtful accounts against its individual accounts receivable based on estimates of expected reimbursement consistent with historical payment experience in relation to the amounts billed. Bad debt expense is included in general and administrative expense on the Company's statements of operations and comprehensive loss. Accounts receivable are written off against the allowance when there is substantive evidence that the account will not be paid. | |||||||||||
The balance of allowance for doubtful accounts as of December 31, 2014 and 2013, including charges to bad debt expense and write-offs, net of recoveries, was as follows: | |||||||||||
As of | |||||||||||
December 31, | |||||||||||
2014 | 2013 | ||||||||||
(In thousands) | |||||||||||
Beginning balance | $ | 107 | $ | 222 | |||||||
Charged to expense | 54 | 109 | |||||||||
Write-offs, net of recoveries | (77 | ) | (224 | ) | |||||||
| | | | | | | | ||||
Ending balance | $ | 84 | $ | 107 | |||||||
| | | | | | | | ||||
| | | | | | | | ||||
Supplies Inventory | Supplies Inventory | ||||||||||
Supplies inventory consists of test reagents and other consumables used in the sample collection kits and in cytopathology and GEC test processing and are valued at the lower of cost or market value. Cost is determined using actual costs on a first-in, first-out basis. | |||||||||||
Property and Equipment | Property and Equipment | ||||||||||
Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation is computed using the straight-line method over the estimated useful lives of the assets, generally between three and five years. Leasehold improvements are amortized using the straight-line method over the shorter of the estimated useful life of the asset or the term of the lease. Maintenance and repairs are charged to expense as incurred, and improvements and betterments are capitalized. When assets are retired or otherwise disposed of, the cost and accumulated depreciation are removed from the balance sheet and any resulting gain or loss is reflected in the statements of operations and comprehensive loss in the period realized. | |||||||||||
Internal-use Software | Internal-use Software | ||||||||||
The Company capitalizes costs incurred in the application development stage to design and implement the software used in the tracking and reporting of laboratory activity. Costs incurred in the development of application software are capitalized and amortized over an estimated useful life of three years on a straight line basis. The total cost, accumulated depreciation and net book value was $927,000, $330,000 and $597,000, respectively, as of December 31, 2014, and was $482,000, $195,000 and $287,000, respectively, as of December 31, 2013, and are included in property and equipment in the Company's consolidated balance sheets. During the years ended December 31, 2014 and 2013, the Company capitalized $445,000 and $212,000, respectively, of software development costs. Amortization expense totaled $135,000, $108,000 and $47,000 in the years ended December 31, 2014, 2013 and 2012, respectively. | |||||||||||
Business Combination | Business Combination | ||||||||||
The Company accounts for acquisitions using the acquisition method of accounting which requires the recognition of tangible and identifiable intangible assets acquired and liabilities assumed at their estimated fair values as of the business combination date. The Company allocates any excess purchase price over the estimated fair value assigned to the net tangible and identifiable intangible assets acquired and liabilities assumed to goodwill. Transaction costs are expensed as incurred in general and administrative expenses. Results of operations and cash flows of acquired companies are included in the Company's operating results from the date of acquisition. | |||||||||||
Goodwill | Goodwill | ||||||||||
Goodwill, derived from the Company's acquisition of Allegro, is reviewed for impairment on an annual basis or more frequently if events or circumstances indicate that it may be impaired. The Company's goodwill evaluation is based on both qualitative and quantitative assessments regarding the fair value of goodwill relative to its carrying value. The Company has determined that it operates in a single segment and has a single reporting unit associated with the development and commercialization of diagnostic products. In the event the Company determines that it is more likely than not the carrying value of the reporting unit is higher than its fair value, quantitative testing is performed comparing recorded values to estimated fair values. If impairment is present, the impairment loss is measured as the excess of the recorded goodwill over its implied fair value. The Company performs its annual evaluation of goodwill during the fourth quarter of each fiscal year. There was no impairment for the year ended December 31, 2014. | |||||||||||
Intangible Assets | Intangible Assets | ||||||||||
The Company's intangible assets are comprised of acquired in-process research and development, or IPR&D. The fair value of IPR&D acquired through a business combination is capitalized as an indefinite-lived intangible asset until the completion or abandonment of the related research and development activities. IPR&D is tested for impairment annually or when events or circumstances indicate that the fair value may be below the carrying value of the asset. There was no impairment for the year ended December 31, 2014. If and when research and development is complete, the associated assets would then be amortized over their estimated useful lives. | |||||||||||
Impairment of Long-lived Assets | Impairment of Long-lived Assets | ||||||||||
The Company annually reviews long-lived and indefinite lived assets other than goodwill for impairment or whenever events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable. The Company recognizes an impairment loss when the total of estimated future undiscounted cash flows expected to result from the use of the asset and its eventual disposition are less than its carrying amount. Impairment, if any, would be assessed using discounted cash flows or other appropriate measures of fair value. There were no impairments for the years ended December 31, 2014 and 2013. | |||||||||||
Bonus Accruals | Bonus Accruals | ||||||||||
The Company accrues for liabilities under discretionary employee and executive bonus plans. These estimated compensation liabilities are based on progress against corporate objectives approved by the Board of Directors, compensation levels of eligible individuals, and target bonus percentage levels. The Board of Directors and the Compensation Committee of the Board of Directors review and evaluate the performance against these objectives and ultimately determine what discretionary payments are made. The Company accrued $1.1 million as of December 31, 2014 and 2013 for liabilities associated with these employee and executive bonus plans which are included in accrued liabilities in the Company's consolidated balance sheets. | |||||||||||
Fair Value of Financial Instruments | Fair Value of Financial Instruments | ||||||||||
The carrying amounts of certain financial instruments including cash and cash equivalents, accounts receivable, prepaid expenses and other current assets, accounts payable and accrued liabilities approximate fair value due to their relatively short maturities. | |||||||||||
Revenue Recognition | Revenue Recognition | ||||||||||
The Company's revenue is generated from the provision of diagnostic services using the Afirma solution. The Company's service is completed upon the delivery of test results to the prescribing physician which triggers the billing for the service. The Company recognizes revenue related to billings for Medicare and commercial payers on an accrual basis, net of contractual adjustments, when a reasonable estimate of reimbursement can be made. These contractual adjustments represent the difference between the list price (the billing rate) and the reimbursement rate for each payer. Upon ultimate collection, the amount received from Medicare and commercial payers where reimbursement was estimated is compared to previous estimates and the contractual allowance is adjusted accordingly. Until a contract has been negotiated with a commercial payer or governmental program, the Afirma solution may or may not be covered by these entities' existing reimbursement policies. In addition, patients do not enter into direct agreements with the Company that commit them to pay any portion of the cost of the tests in the event that their insurance declines to reimburse the Company. In the absence of an agreement with the patient or other clearly enforceable legal right to demand payment from the patient, the related revenue is only recognized upon the earlier of payment notification, if applicable, or cash receipt. | |||||||||||
For all services performed, the Company considers whether or not the following revenue recognition criteria are met: persuasive evidence of an arrangement exists; delivery has occurred or services have been rendered; and a reasonable estimate of reimbursement can be made. | |||||||||||
Persuasive evidence of an arrangement exists and delivery is deemed to have occurred upon delivery of a patient report to the prescribing physician. The assessment of whether a reasonable estimate of reimbursement can be made requires significant judgment by management. Where management's judgment indicates a reasonable estimate of reimbursement can be made, revenue is recognized upon delivery of the patient report. Some patients have out-of-pocket costs for amounts not covered by their insurance carrier, and the Company may bill the patient directly for these amounts in the form of co-payments and co-insurance in accordance with their insurance carrier and health plans. Some payers may not cover the Company's GEC as ordered by the prescribing physician under their reimbursement policies. The Company pursues reimbursement from such patients on a case-by-case basis. In the absence of contracted reimbursement coverage or the ability to reasonably estimate reimbursement, the Company recognizes revenue upon receipt of third-party payer notification of payment or when cash is received. | |||||||||||
Revenue recognized when cash is received was $25.7 million, $14.6 million and $7.5 million for the years ended December 31, 2014, 2013 and 2012, respectively. Revenue recognized on an accrual basis was $12.5 million, $7.3 million and $4.1 million for the years ended December 31, 2014, 2013 and 2012, respectively. | |||||||||||
Cost of Revenue | Cost of Revenue | ||||||||||
Cost of revenue is expensed as incurred and includes material and service costs, cytopathology testing services performed by a third-party pathology group, stock-based compensation expense, direct labor costs, equipment and infrastructure expenses associated with testing samples, shipping charges to transport samples, and allocated overhead including rent, information technology, equipment depreciation and utilities. | |||||||||||
Research and Development | Research and Development | ||||||||||
Research and development costs are charged to operations as incurred. Research and development costs include, but are not limited to, payroll and personnel-related expenses, stock-based compensation expense, prototype materials, laboratory supplies, consulting costs, costs associated with setting up and conducting clinical studies at domestic and international sites, and allocated overhead including rent, information technology, equipment depreciation and utilities. | |||||||||||
Income Taxes | Income Taxes | ||||||||||
The Company accounts for income taxes under the liability method. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amounts expected to be realized. | |||||||||||
The Company assesses all material positions taken in any income tax return, including all significant uncertain positions, in all tax years that are still subject to assessment or challenge by relevant taxing authorities. The Company's assessment of an uncertain tax position begins with the initial determination of the position's sustainability and is measured at the largest amount of benefit that is more-likely-than-not of being realized upon ultimate settlement. As of each balance sheet date, unresolved uncertain tax positions must be reassessed, and the Company will determine whether (i) the factors underlying the sustainability assertion have changed and (ii) the amount of the recognized tax benefit is still appropriate. The recognition and measurement of tax benefits requires significant judgment. Judgments concerning the recognition and measurement of a tax benefit may change as new information becomes available. | |||||||||||
Stock-based Compensation | Stock-based Compensation | ||||||||||
Stock-based compensation expense for equity instruments issued to employees is measured based on the grant-date fair value of the awards. The fair value of each employee stock option is estimated on the date of grant using the Black-Scholes option-pricing model. The Company recognizes compensation costs on a straight-line basis for all employee stock based compensation awards that are expected to vest over the requisite service period of the awards, which is generally the awards' vesting period. Forfeitures are required to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. | |||||||||||
Equity awards issued to non-employees are valued using the Black-Scholes option-pricing model and are subject to re-measurement as the underlying equity awards vest. | |||||||||||
Net Loss per Common Share | Net Loss per Common Share | ||||||||||
Basic net loss per common share is calculated by dividing net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period, without consideration of common stock equivalents. Diluted net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted-average number of common share equivalents outstanding for the period determined using the treasury stock method. Potentially dilutive securities consisting of options and warrants to purchase common stock are considered to be common stock equivalents and were excluded from the calculation of diluted net loss per common share because their effect would be anti-dilutive for all periods presented. | |||||||||||
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, requiring an entity to recognize the amount of revenue to which it expects to be entitled for the transfer of promised goods or services to customers. The updated standard will replace most existing revenue recognition guidance in GAAP when it becomes effective and permits the use of either the retrospective or cumulative effect transition method. Early adoption is not permitted. The updated standard becomes effective for the Company in the first quarter of fiscal 2017. The Company has not yet selected a transition method and is currently evaluating the potential effect of the updated standard on its financial statements. | |||||||||||
In August 2014, FASB issued Accounting Standards Update No. 2014-15, Presentation of Financial Statements Going Concern—Disclosure of Uncertainties about an Entity's Ability to Continue as a Going Concern. The amendments require management to assess an entity's ability to continue as a going concern by incorporating and expanding upon certain principles that are currently in U.S. auditing standards. Specifically, the amendments: (1) provide a definition of the term substantial doubt; (2) require an evaluation every reporting period including interim periods; (3) provide principles for considering the mitigating effect of management's plans; (4) require certain disclosures when substantial doubt is alleviated as a result of consideration of management's plans; (5) require an express statement and other disclosures when substantial doubt is not alleviated; and (6) require an assessment for a period of one year after the date that the financial statements are issued (or available to be issued). ASU 2014-15 will be effective for annual periods ending after December 15, 2016 and interim periods within annual periods beginning after December 15, 2016 with early adoption permitted. ASU 2014-15 will be effective for the Company beginning with its annual report for fiscal 2016 and interim periods thereafter. The Company has not yet determined the effect of the adoption of this standard on the Company's consolidated financial statements. | |||||||||||
Summary_of_Significant_Account2
Summary of Significant Accounting Policies (Tables) | 12 Months Ended | ||||||||||
Dec. 31, 2014 | |||||||||||
Summary of Significant Accounting Policies | |||||||||||
Schedule of balance of allowance for doubtful accounts, including charges to bad debt expense and write-offs, net of recoveries | |||||||||||
As of | |||||||||||
December 31, | |||||||||||
2014 | 2013 | ||||||||||
(In thousands) | |||||||||||
Beginning balance | $ | 107 | $ | 222 | |||||||
Charged to expense | 54 | 109 | |||||||||
Write-offs, net of recoveries | (77 | ) | (224 | ) | |||||||
| | | | | | | | ||||
Ending balance | $ | 84 | $ | 107 | |||||||
| | | | | | | | ||||
| | | | | | | | ||||
Revenue concentration risk | Revenue | |||||||||||
Summary of Significant Accounting Policies | |||||||||||
Schedule of the Company's third-party payers as a percentage of total | |||||||||||
Year Ended | |||||||||||
December 31, | |||||||||||
2014 | 2013 | 2012 | |||||||||
Medicare | 26 | % | 32 | % | 34 | % | |||||
Aetna | 11 | % | 9 | % | 13 | % | |||||
United Healthcare | 18 | % | 18 | % | 12 | % | |||||
| | | | | | | | | | | |
55 | % | 59 | % | 59 | % | ||||||
| | | | | | | | | | | |
| | | | | | | | | | | |
Gross receivables concentration risk | Accounts receivable | |||||||||||
Summary of Significant Accounting Policies | |||||||||||
Schedule of the Company's third-party payers as a percentage of total | |||||||||||
December 31, | |||||||||||
2014 | 2013 | ||||||||||
Medicare | 64 | % | 78 | % | |||||||
Aetna | 12 | % | — | ||||||||
United Healthcare | 14 | % | 3 | % | |||||||
Net_Loss_Per_Common_Share_Tabl
Net Loss Per Common Share (Tables) | 12 Months Ended | ||||||||||
Dec. 31, 2014 | |||||||||||
Net Loss Per Common Share | |||||||||||
Schedule of the calculation of basic and diluted net loss per common share | The following table presents the calculation of basic and diluted net loss per common share for the years ended December 31, 2014, 2013 and 2012 (in thousands, except share and per share amounts): | ||||||||||
Year Ended | |||||||||||
December 31, | |||||||||||
2014 | 2013 | 2012 | |||||||||
Net loss | $ | (29,373 | ) | $ | (25,580 | ) | $ | (18,649 | ) | ||
| | | | | | | | | | | |
| | | | | | | | | | | |
Shares used to compute net loss per common share, basic and diluted | 21,639,374 | 4,158,664 | 650,333 | ||||||||
| | | | | | | | | | | |
| | | | | | | | | | | |
Net loss per common share, basic and diluted | $ | (1.36 | ) | $ | (6.15 | ) | $ | (28.68 | ) | ||
| | | | | | | | | | | |
| | | | | | | | | | | |
Schedule of outstanding shares of common stock equivalents that have been excluded from diluted net loss per common share | |||||||||||
Year Ended | |||||||||||
December 31, | |||||||||||
2014 | 2013 | ||||||||||
Shares of common stock subject to outstanding options | 3,249,469 | 2,359,287 | |||||||||
Shares of common stock issuable upon exercise of warrants | — | 24,801 | |||||||||
| | | | | | | | ||||
Total shares of common stock equivalents | 3,249,469 | 2,384,088 | |||||||||
| | | | | | | | ||||
| | | | | | | | ||||
Business_Combination_Tables
Business Combination (Tables) | 12 Months Ended | |||||||
Dec. 31, 2014 | ||||||||
Business Combination | ||||||||
Schedule of pro forma financial information as if the Merger had occurred as of January1, 2013 | The following pro forma financial information is based on the historical financial statements of the Company and presents the Company's results as if the Merger had occurred as of January 1, 2013 (in thousands): | |||||||
Year Ended | ||||||||
December 31, | ||||||||
2014 | 2013 | |||||||
Revenue | $ | 38,190 | $ | 21,884 | ||||
| | | | | | | | |
| | | | | | | | |
Net loss | $ | (29,090 | ) | $ | (28,605 | ) | ||
| | | | | | | | |
| | | | | | | | |
Allegro | ||||||||
Business Combination | ||||||||
Schedule of acquisition consideration | The acquisition consideration was comprised of (in thousands): | |||||||
Stock | $ | 10,078 | ||||||
Cash | 2,725 | |||||||
Payment of outstanding indebtedness | 4,290 | |||||||
| | | | | ||||
Total acquisition consideration | $ | 17,093 | ||||||
| | | | | ||||
| | | | | ||||
Schedule of fair value of assets acquired and liabilities assumed | The fair value of the assets acquired and liabilities assumed at the closing date of the Merger are summarized below (in thousands): | |||||||
Cash and cash equivalents | $ | 29 | ||||||
Prepaid expenses | 3 | |||||||
Other current assets | 13 | |||||||
In-process research and development ("IPR&D") | 16,000 | |||||||
Goodwill | 1,057 | |||||||
Accrued liabilities | (9 | ) | ||||||
| | | | | ||||
Total net assets acquired | $ | 17,093 | ||||||
| | | | | ||||
| | | | | ||||
Balance_Sheet_Components_Table
Balance Sheet Components (Tables) | 12 Months Ended | ||||||||||
Dec. 31, 2014 | |||||||||||
Balance Sheet Components | |||||||||||
Schedule of property and equipment | Property and equipment consisted of the following (in thousands): | ||||||||||
Year Ended | |||||||||||
December 31, | |||||||||||
2014 | 2013 | ||||||||||
Leasehold improvements | $ | 788 | $ | 779 | |||||||
Laboratory equipment | 4,199 | 2,946 | |||||||||
Computer equipment | 875 | 645 | |||||||||
Software, including software developed for internal use | 1,353 | 901 | |||||||||
Furniture and fixtures | 197 | 189 | |||||||||
Construction-in-process | 739 | 307 | |||||||||
| | | | | | | | ||||
Total property and equipment, at cost | 8,151 | 5,767 | |||||||||
Accumulated depreciation and amortization | (3,990 | ) | (2,815 | ) | |||||||
| | | | | | | | ||||
Total property and equipment, net | $ | 4,161 | $ | 2,952 | |||||||
| | | | | | | | ||||
| | | | | | | | ||||
Schedule of depreciation and amortization expense recorded in the statements of operations and comprehensive loss | Depreciation and amortization expense was $1,175,000, $999,000 and $706,000 for the years ended December 31, 2014, 2013 and 2012, respectively, and was recorded in the statements of operations and comprehensive loss as follows (in thousands): | ||||||||||
Year Ended | |||||||||||
December 31, | |||||||||||
2014 | 2013 | 2012 | |||||||||
Cost of revenue | $ | 677 | $ | 593 | $ | 401 | |||||
Research and development | 187 | 179 | 184 | ||||||||
Selling and marketing | 101 | 54 | 46 | ||||||||
General and administrative | 210 | 173 | 75 | ||||||||
| | | | | | | | | | | |
Total depreciation and amortization expense | $ | 1,175 | $ | 999 | $ | 706 | |||||
| | | | | | | | | | | |
| | | | | | | | | | | |
Schedule of accrued liabilities | Accrued liabilities consisted of the following (in thousands): | ||||||||||
Year Ended | |||||||||||
December 31, | |||||||||||
2014 | 2013 | ||||||||||
Accrued compensation expenses | $ | 2,673 | $ | 1,962 | |||||||
Accrued Genzyme co-promotion fees | 3,309 | 4,915 | |||||||||
Accrued other | 1,869 | 717 | |||||||||
| | | | | | | | ||||
Total accrued liabilities | $ | 7,851 | $ | 7,594 | |||||||
| | | | | | | | ||||
| | | | | | | | ||||
Fair_Value_Measurements_Tables
Fair Value Measurements (Tables) | 12 Months Ended | |||||||
Dec. 31, 2014 | ||||||||
Fair Value Measurements | ||||||||
Summary of the changes in the fair value of the Company's Level 3 financial liabilities, which are measured on a recurring basis | The following table sets forth the changes in the fair value of the Company's Level III financial liabilities, which consisted of a preferred stock liability during 2013, which were measured on a recurring basis (in thousands): | |||||||
December 31, | ||||||||
2014 | 2013 | |||||||
Beginning balance | $ | — | $ | 583 | ||||
Change in fair value of preferred stock liability recorded as other expense, net | — | 2,070 | ||||||
Settlement of preferred stock liability | — | (2,653 | ) | |||||
Fair value of preferred stock warrant liability | — | 175 | ||||||
Change in fair value of preferred stock warrant liability recorded as other expense, net | — | 86 | ||||||
Conversion of preferred stock warrant liability | — | (261 | ) | |||||
| | | | | | | | |
Ending balance | $ | — | $ | — | ||||
| | | | | | | | |
| | | | | | | | |
Commitments_and_Contingencies_
Commitments and Contingencies (Tables) | 12 Months Ended | ||||
Dec. 31, 2014 | |||||
Commitments and Contingencies | |||||
Schedule of future minimum lease payments under non-cancelable operating leases | Future minimum lease payments under non-cancelable operating leases as of December 31, 2014 are as follows (in thousands): | ||||
Year Ending December 31, | Amounts | ||||
2015 | $ | 989 | |||
2016 | 413 | ||||
2017 | 222 | ||||
2018 | 130 | ||||
Thereafter | — | ||||
| | | | | |
Total minimum lease payments | $ | 1,754 | |||
| | | | | |
| | | | | |
Debt_Tables
Debt (Tables) | 12 Months Ended | |||||||
Dec. 31, 2014 | ||||||||
Debt | ||||||||
Schedule of net debt obligation | As of December 31, 2014 and 2013, the net debt obligation was as follows (in thousands): | |||||||
December 31, | ||||||||
2014 | 2013 | |||||||
Debt and unpaid accrued end-of term payment | $ | 5,003 | $ | 5,042 | ||||
Unamorized note discount | (80 | ) | (143 | ) | ||||
| | | | | | | | |
Net debt obligation | $ | 4,923 | $ | 4,899 | ||||
| | | | | | | | |
| | | | | | | | |
Schedule of future principal payments under the Amended Loan | Future principal payments under the Amended Loan are as follows (in thousands): | |||||||
Year ending December 31: | ||||||||
2015 | $ | — | ||||||
2016 | — | |||||||
2017 | 2,437 | |||||||
2018 | 2,563 | |||||||
| | | | | ||||
Total | $ | 5,000 | ||||||
| | | | | ||||
| | | | | ||||
Schedule of interest expense on debt | Interest expense on the debt was as follows (in thousands): | |||||||
Year Ended | ||||||||
December 31, | ||||||||
2014 | 2013 | |||||||
Nominal interest | $ | 296 | $ | 158 | ||||
Amortization of debt discount | 62 | 33 | ||||||
End-of-term payment interest | 81 | 42 | ||||||
| | | | | | | | |
Total | $ | 439 | $ | 233 | ||||
| | | | | | | | |
| | | | | | | | |
Stockholders_Equity_Deficit_Ta
Stockholders' Equity (Deficit) (Tables) | 12 Months Ended | |||||||
Dec. 31, 2014 | ||||||||
Stockholders' Equity | ||||||||
Schedule of reserved shares of common stock for issuance | ||||||||
December 31, | December 31, | |||||||
2014 | 2013 | |||||||
Options issued and outstanding | 3,249,469 | 2,359,287 | ||||||
Options available for grant under stock option plans | 1,341,252 | 1,787,802 | ||||||
Common stock warrants issued and outstanding | — | 24,801 | ||||||
| | | | | | | | |
Total | 4,590,721 | 4,171,890 | ||||||
| | | | | | | | |
| | | | | | | | |
Stock_Incentive_Plans_Tables
Stock Incentive Plans (Tables) | 12 Months Ended | ||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||
Stock incentive plans | |||||||||||||||||
Summary of activity under the Company's stock option plans | The following table summarizes activity under the Company's stock option plans (aggregate intrinsic value in thousands): | ||||||||||||||||
Shares | Stock Options | Weighted | Weighted Average | Aggregate | |||||||||||||
Available | Outstanding | Average | Remaining | Intrinsic | |||||||||||||
for Grant | Exercise Price | Contractual Life | Value | ||||||||||||||
(Years) | |||||||||||||||||
Balance—December 31, 2011 | 474,961 | 1,429,737 | $ | 1.55 | 8.22 | $ | 1,221 | ||||||||||
Additional options authorized | 743,100 | — | |||||||||||||||
Granted | (931,944 | ) | 931,944 | 2.78 | |||||||||||||
Canceled | 61,269 | (61,269 | ) | 1.97 | |||||||||||||
Exercised | — | (72,743 | ) | 1.05 | |||||||||||||
| | | | | | | | | | | | | | | | | |
Balance—December 31, 2012 | 347,386 | 2,227,669 | $ | 2.06 | 8.17 | $ | 4,311 | ||||||||||
Additional options authorized | 1,950,000 | — | |||||||||||||||
Granted | (695,029 | ) | 695,029 | 5.32 | |||||||||||||
Canceled | 185,445 | (185,445 | ) | 2.69 | |||||||||||||
Exercised | — | (377,966 | ) | 1.46 | |||||||||||||
| | | | | | | | | | | | | | | | | |
Balance—December 31, 2013 | 1,787,802 | 2,359,287 | $ | 3.07 | 7.84 | $ | 26,964 | ||||||||||
Additional options authorized | 845,732 | — | |||||||||||||||
Granted | (1,488,492 | ) | 1,488,492 | 13.38 | |||||||||||||
Canceled | 196,210 | (196,210 | ) | 9.37 | |||||||||||||
Exercised | — | (402,100 | ) | 1.68 | |||||||||||||
| | | | | | | | | | | | | | | | | |
Balance—December 31, 2014 | 1,341,252 | 3,249,469 | $ | 7.59 | 7.88 | $ | 12,400 | ||||||||||
| | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | |
Options vested and exercisable—December 31, 2014 | 1,370,944 | $ | 2.92 | 6.44 | $ | 9,287 | |||||||||||
Options vested and expected to vest—December 31, 2014 | 3,092,476 | $ | 7.32 | 7.81 | $ | 12,295 | |||||||||||
Stock-based Compensation | |||||||||||||||||
Stock incentive plans | |||||||||||||||||
Summary of share-based compensation expense | The following table summarizes stock-based compensation expense related to stock options for the years ended December 31, 2014, 2013 and 2012, and are included in the consolidated statements of operations and comprehensive loss as follows (in thousands): | ||||||||||||||||
Year Ended December 31, | |||||||||||||||||
2014 | 2013 | 2012 | |||||||||||||||
Cost of revenue | $ | 51 | $ | 34 | $ | 26 | |||||||||||
Research and development | 790 | 250 | 131 | ||||||||||||||
Selling and marketing | 707 | 169 | 111 | ||||||||||||||
General and administrative | 2,000 | 794 | 407 | ||||||||||||||
| | | | | | | | | | | |||||||
Total stock-based compensation expense | $ | 3,548 | $ | 1,247 | $ | 675 | |||||||||||
| | | | | | | | | | | |||||||
| | | | | | | | | | | |||||||
Stock-based Compensation, employees | |||||||||||||||||
Stock incentive plans | |||||||||||||||||
Schedule of assumptions used to calculate estimated grant date fair value of stock options using the Black-Scholes option-pricing valuation model | |||||||||||||||||
Year Ended December 31, | |||||||||||||||||
2014 | 2013 | 2012 | |||||||||||||||
Weighted-average volatility | 70.19 - 78.54% | 80.42 - 81.41% | 82.07 - 84.33% | ||||||||||||||
Weighted-average expected term (years) | 5.50 - 6.08 | 5.00 - 6.08 | 5.00 - 6.08 | ||||||||||||||
Risk-free interest rate | 1.66 - 2.04% | 0.88 - 2.11% | 0.65 - 1.19% | ||||||||||||||
Expected dividend yield | — | — | — | ||||||||||||||
Stock-based Compensation, non-employees | |||||||||||||||||
Stock incentive plans | |||||||||||||||||
Schedule of assumptions used to calculate estimated grant date fair value of stock options using the Black-Scholes option-pricing valuation model | |||||||||||||||||
Year Ended December 31, | |||||||||||||||||
2014 | 2013 | 2012 | |||||||||||||||
Weighted-average volatility | 73.20 - 74.48% | 77.86 - 78.14% | 81.14 - 82.11% | ||||||||||||||
Weighted-average expected term (years) | 8.75 - 10.00 | 7.72 - 9.75 | 8.23 - 9.93 | ||||||||||||||
Risk-free interest rate | 2.09 - 2.20% | 2.59 - 2.99% | 1.43 - 1.77% | ||||||||||||||
Expected dividend yield | — | — | — | ||||||||||||||
Income_Taxes_Tables
Income Taxes (Tables) | 12 Months Ended | ||||||||||
Dec. 31, 2014 | |||||||||||
Income Taxes | |||||||||||
Schedule of reconciliation of tax expense computed at the statutory federal rate and the Company's tax expense | The following table presents a reconciliation of the tax expense computed at the statutory federal rate and the Company's tax expense for the period presented (in thousands): | ||||||||||
Year Ended December, 31, | |||||||||||
2014 | 2013 | 2012 | |||||||||
U.S. federal taxes at statutory rate | $ | (9,987 | ) | $ | (8,697 | ) | $ | (6,341 | ) | ||
State tax (net of federal benefit) | 5 | 11 | (1,074 | ) | |||||||
Permanent differences | 64 | 790 | (23 | ) | |||||||
Incentive stock options | 672 | 355 | 284 | ||||||||
Tax credits | (461 | ) | (502 | ) | (113 | ) | |||||
Change in valuation allowance | 9,707 | 8,043 | 7,267 | ||||||||
| | | | | | | | | | | |
Total | $ | — | $ | — | $ | — | |||||
| | | | | | | | | | | |
| | | | | | | | | | | |
Schedule of significant components of the Company's deferred tax assets and liabilities | Significant components of the Company's deferred tax assets and liabilities are as follows (in thousands): | ||||||||||
Year Ended December 31, | |||||||||||
2014 | 2013 | 2012 | |||||||||
Current deferred tax assets: | |||||||||||
Genzyme co-promotion agreement | $ | 793 | $ | 1,005 | $ | 1,001 | |||||
Accruals and deferred rent | 1,819 | 599 | 148 | ||||||||
| | | | | | | | | | | |
Gross deferred tax assets | 2,612 | 1,604 | 1,149 | ||||||||
Valuation allowance | (2,312 | ) | (1,603 | ) | (1,145 | ) | |||||
| | | | | | | | | | | |
Net deferred tax assets | 300 | 1 | 4 | ||||||||
| | | | | | | | | | | |
Non-current deferred tax assets: | |||||||||||
Net operating loss carryforwards | 41,971 | 28,569 | 20,536 | ||||||||
Research and development credits | 1,916 | 1,455 | 954 | ||||||||
Stock-based compensation | 826 | 313 | 154 | ||||||||
Genzyme co-promotion agreement | 202 | 787 | 2,048 | ||||||||
Accruals, deferred rent and other | 1,562 | 106 | 9 | ||||||||
| | | | | | | | | | | |
Gross deferred tax assets | 46,477 | 31,230 | 23,701 | ||||||||
Valuation allowance | (41,127 | ) | (31,216 | ) | (23,622 | ) | |||||
| | | | | | | | | | | |
Net deferred tax assets | 5,350 | 14 | 79 | ||||||||
| | | | | | | | | | | |
Deferred tax liabilities: | |||||||||||
Property and equipment | (60 | ) | (15 | ) | (83 | ) | |||||
In-process research and development | (5,590 | ) | — | — | |||||||
| | | | | | | | | | | |
Gross deferred tax liabilities | (5,650 | ) | (15 | ) | (83 | ) | |||||
| | | | | | | | | | | |
Net non-current deferred tax liabilities | (300 | ) | (1 | ) | (4 | ) | |||||
| | | | | | | | | | | |
Total deferred tax assets | $ | — | $ | — | $ | — | |||||
| | | | | | | | | | | |
| | | | | | | | | | | |
Schedule of reconciliation of the beginning and ending amount of unrecognized tax benefits | A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows (in thousands): | ||||||||||
Year Ended | |||||||||||
December 31, | |||||||||||
2014 | 2013 | 2012 | |||||||||
Unrecognized tax benefits, beginning of period | $ | 727 | $ | 481 | $ | 341 | |||||
Gross increases—tax position in prior period | 548 | 68 | 67 | ||||||||
Gross increases—current period tax positions | 296 | 178 | 73 | ||||||||
| | | | | | | | | | | |
Unrecognized tax benefits, end of period | $ | 1,571 | $ | 727 | $ | 481 | |||||
| | | | | | | | | | | |
| | | | | | | | | | | |
Selected_Quarterly_Financial_D1
Selected Quarterly Financial Data (Unaudited) (Tables) | 12 Months Ended | |||||||||||||
Dec. 31, 2014 | ||||||||||||||
Selected Quarterly Financial Data (Unaudited) | ||||||||||||||
Schedule of selected quarterly financial data (unaudited) | ||||||||||||||
Quarter Ended | March 31 | June 30 | September 30 | December 31 | ||||||||||
(In thousands, except share and per share data) | ||||||||||||||
2014:00:00 | ||||||||||||||
Total revenues | $ | 7,476 | $ | 8,677 | $ | 9,838 | $ | 12,199 | ||||||
Net loss | (6,674 | ) | (6,655 | ) | (7,902 | ) | (8,142 | ) | ||||||
Net loss per common share, basic and diluted | (0.32 | ) | (0.31 | ) | (0.37 | ) | (0.36 | ) | ||||||
Shares used to compute net loss per common share, basic and diluted | 21,148,342 | 21,237,196 | 21,648,660 | 22,508,250 | ||||||||||
2013:00:00 | ||||||||||||||
Total revenues | $ | 4,384 | $ | 5,068 | $ | 5,594 | $ | 6,838 | ||||||
Net loss | (6,895 | ) | (6,490 | ) | (6,303 | ) | (5,892 | ) | ||||||
Net loss per common share, basic and diluted | (9.04 | ) | (7.53 | ) | (6.59 | ) | (0.42 | ) | ||||||
Shares used to compute net loss per common share, basic and diluted | 763,021 | 861,839 | 955,890 | 13,944,239 | ||||||||||
Organization_and_Description_o1
Organization and Description of Business (Details) (USD $) | 0 Months Ended | 12 Months Ended | |
In Millions, except Share data, unless otherwise specified | Nov. 04, 2013 | Dec. 31, 2014 | Dec. 31, 2013 |
item | |||
Organization and Description of Business | |||
Number of patients who undergo bronchoscopy in the United States each year | 250,000 | ||
Initial Public Offering | |||
Net proceeds from issuance of common stock in IPO | $59.20 | ||
Underwriting discounts and commissions | 4.6 | ||
Offering expenses | $2.50 | ||
Common Stock | |||
Initial Public Offering | |||
Number of shares issued and sold in IPO | 5,100,351 | 5,100,351 | |
Issuance price per share in IPO (in dollars per share) | $13 | 9.66 | $14.50 |
Common stock issued on automatic conversion of outstanding convertible preferred stock (in shares) | 14,997,312 | 14,997,312 |
Summary_of_Significant_Account3
Summary of Significant Accounting Policies (Details) (USD $) | 12 Months Ended | |||
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 |
Institution | ||||
Liquidity | ||||
Accumulated deficit | ($115,022) | ($85,649) | ||
Cash and cash equivalents | 35,014 | 71,220 | 14,002 | 7,566 |
Concentrations of Credit Risk and Other Risks and Uncertainties | ||||
Number of major financial institutions with which the company's cash and cash equivalents are deposited | 1 | |||
Restricted Cash | ||||
Cash reserved to cover liabilities associated with Merger | 70 | |||
Long term deposit consisting of letter of credit serving as security for lease | 118 | 118 | ||
Activity of allowance for doubtful accounts | ||||
Beginning balance | 107 | 222 | ||
Charged to expense | 54 | 109 | 225 | |
Write-offs, net of recoveries | -77 | -224 | ||
Ending balance | $84 | $107 | $222 | |
Revenue | Revenue concentration risk | ||||
Concentrations of Credit Risk and Other Risks and Uncertainties | ||||
Concentrations of credit risk (as a percent) | 55.00% | 59.00% | 59.00% | |
Revenue | Revenue concentration risk | Medicare | ||||
Concentrations of Credit Risk and Other Risks and Uncertainties | ||||
Concentrations of credit risk (as a percent) | 26.00% | 32.00% | 34.00% | |
Revenue | Revenue concentration risk | Aetna | ||||
Concentrations of Credit Risk and Other Risks and Uncertainties | ||||
Concentrations of credit risk (as a percent) | 11.00% | 9.00% | 13.00% | |
Revenue | Revenue concentration risk | United Healthcare | ||||
Concentrations of Credit Risk and Other Risks and Uncertainties | ||||
Concentrations of credit risk (as a percent) | 18.00% | 18.00% | 12.00% | |
Accounts receivable | Gross receivables concentration risk | Medicare | ||||
Concentrations of Credit Risk and Other Risks and Uncertainties | ||||
Concentrations of credit risk (as a percent) | 64.00% | 78.00% | ||
Accounts receivable | Gross receivables concentration risk | Aetna | ||||
Concentrations of Credit Risk and Other Risks and Uncertainties | ||||
Concentrations of credit risk (as a percent) | 12.00% | |||
Accounts receivable | Gross receivables concentration risk | United Healthcare | ||||
Concentrations of Credit Risk and Other Risks and Uncertainties | ||||
Concentrations of credit risk (as a percent) | 14.00% | 3.00% |
Summary_of_Significant_Account4
Summary of Significant Accounting Policies (Details 2) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Internal-use Software | |||
Total cost | $8,151,000 | $5,767,000 | |
Accumulated depreciation | 3,990,000 | 2,815,000 | |
Net book value | 4,161,000 | 2,952,000 | |
Minimum | |||
Property and Equipment and Internal-use Software | |||
Estimated useful life | 3 years | ||
Maximum | |||
Property and Equipment and Internal-use Software | |||
Estimated useful life | 5 years | ||
Capitalized software | |||
Property and Equipment and Internal-use Software | |||
Estimated useful life | 3 years | ||
Internal-use Software | |||
Total cost | 927,000 | 482,000 | |
Accumulated depreciation | 330,000 | 195,000 | |
Net book value | 597,000 | 287,000 | |
Capitalized costs | 445,000 | 212,000 | |
Amortization expense | $135,000 | $108,000 | $47,000 |
Summary_of_Significant_Account5
Summary of Significant Accounting Policies (Details 3) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Asset impairment | |||
Goodwill impairment | $0 | ||
Indefinite lived assets, other than goodwill, impairment | 0 | ||
Long-lived asset impairment | 0 | 0 | |
Bonus Accruals | |||
Accrued liabilities associated with employee and executive bonus plans | 1,100,000 | 1,100,000 | |
Revenue Recognition | |||
Revenue recognized when cash is received | 25,700,000 | 14,600,000 | 7,500,000 |
Revenue recognized on accrual basis | $12,500,000 | $7,300,000 | $4,100,000 |
Net_Loss_Per_Common_Share_Deta
Net Loss Per Common Share (Details) (USD $) | 3 Months Ended | 12 Months Ended | |||||||||
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2013 | Sep. 30, 2013 | Jun. 30, 2013 | Mar. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Calculation of basic and diluted net loss per common share | |||||||||||
Net loss | ($8,142) | ($7,902) | ($6,655) | ($6,674) | ($5,892) | ($6,303) | ($6,490) | ($6,895) | ($29,373) | ($25,580) | ($18,649) |
Shares used to compute net loss per common share, basic and diluted (in shares) | 22,508,250 | 21,648,660 | 21,237,196 | 21,148,342 | 13,944,239 | 955,890 | 861,839 | 763,021 | 21,639,374 | 4,158,664 | 650,333 |
Net loss per common share, basic and diluted (in dollars per share) | ($0.36) | ($0.37) | ($0.31) | ($0.32) | ($0.42) | ($6.59) | ($7.53) | ($9.04) | ($1.36) | ($6.15) | ($28.68) |
Outstanding shares of common stock equivalents that have been excluded from diluted net loss per common share | |||||||||||
Total shares of common stock equivalents (in shares) | 3,249,469 | 2,384,088 | |||||||||
Options | |||||||||||
Outstanding shares of common stock equivalents that have been excluded from diluted net loss per common share | |||||||||||
Total shares of common stock equivalents (in shares) | 3,249,469 | 2,359,287 | |||||||||
Common Stock Warrants | |||||||||||
Outstanding shares of common stock equivalents that have been excluded from diluted net loss per common share | |||||||||||
Total shares of common stock equivalents (in shares) | 24,801 |
Business_Combination_Details
Business Combination (Details) (USD $) | 12 Months Ended | 0 Months Ended | |
Dec. 31, 2014 | Dec. 31, 2013 | Sep. 16, 2014 | |
Fair value of the assets acquired and liabilities assumed: | |||
Goodwill | $1,057,000 | ||
Pro-Forma Financial Information | |||
Revenue | 38,190,000 | 21,884,000 | |
Net loss | -29,090,000 | -28,605,000 | |
Allegro | |||
Business Acquisition [Line Items] | |||
Number of Allegro shares received for each share of common stock issued and outstanding of a wholly-owned subsidiary of the Company | 1 | ||
Conversion right, number of shares | 964,377 | ||
Conversion right, cash | 2,700,000 | ||
Outstanding indebtedness settled in cash | 4,300,000 | ||
Acquisition-related costs | 500,000 | ||
Transaction bonuses and severance payments | 1,200,000 | ||
Acquisition consideration | |||
Stock | 10,078,000 | ||
Cash | 2,725,000 | ||
Payment of outstanding indebtedness | 4,290,000 | ||
Total acquisition consideration | 17,093,000 | ||
Closing price of Company's common stock | $10.45 | ||
Fair value of the assets acquired and liabilities assumed: | |||
Cash and cash equivalents | 29,000 | ||
Prepaid expenses | 3,000 | ||
Other current assets | 13,000 | ||
In-process research and development | 16,000,000 | ||
Goodwill | 1,057,000 | ||
Accrued liabilities | -9,000 | ||
Total net assets acquired | 17,093,000 | ||
Discount rate (as a percent) | 18.50% | ||
Allegro | Transaction bonus and other payments to employees and acquisition related costs | |||
Pro-Forma Financial Information | |||
Net loss | 2,200,000 | ||
Allegro | Interest expense related to indebtedness of acquired entity | |||
Pro-Forma Financial Information | |||
Net loss | $2,300,000 | $4,500,000 | |
Allegro | IPR&D | Maximum | |||
Fair value of the assets acquired and liabilities assumed: | |||
Useful life | 20 years |
Balance_Sheet_Components_Detai
Balance Sheet Components (Details) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Property and Equipment, Net | |||
Total property and equipment, at cost | $8,151,000 | $5,767,000 | |
Accumulated depreciation and amortization | -3,990,000 | -2,815,000 | |
Total property and equipment, net | 4,161,000 | 2,952,000 | |
Depreciation and amortization expense | 1,175,000 | 999,000 | 706,000 |
Cost of revenue | |||
Property and Equipment, Net | |||
Depreciation and amortization expense | 677,000 | 593,000 | 401,000 |
Research and development | |||
Property and Equipment, Net | |||
Depreciation and amortization expense | 187,000 | 179,000 | 184,000 |
Selling and marketing | |||
Property and Equipment, Net | |||
Depreciation and amortization expense | 101,000 | 54,000 | 46,000 |
General and administrative | |||
Property and Equipment, Net | |||
Depreciation and amortization expense | 210,000 | 173,000 | 75,000 |
Leasehold improvements | |||
Property and Equipment, Net | |||
Total property and equipment, at cost | 788,000 | 779,000 | |
Laboratory equipment | |||
Property and Equipment, Net | |||
Total property and equipment, at cost | 4,199,000 | 2,946,000 | |
Computer equipment | |||
Property and Equipment, Net | |||
Total property and equipment, at cost | 875,000 | 645,000 | |
Software, including software developed for internal use | |||
Property and Equipment, Net | |||
Total property and equipment, at cost | 1,353,000 | 901,000 | |
Furniture and fixtures | |||
Property and Equipment, Net | |||
Total property and equipment, at cost | 197,000 | 189,000 | |
Construction-in-process | |||
Property and Equipment, Net | |||
Total property and equipment, at cost | $739,000 | $307,000 |
Balance_Sheet_Components_Detai1
Balance Sheet Components (Details 2) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Accrued Liabilities | ||
Accrued compensation expenses | $2,673 | $1,962 |
Accrued Genzyme co-promotion fees | 3,309 | 4,915 |
Accrued other | 1,869 | 717 |
Total accrued liabilities | $7,851 | $7,594 |
Fair_Value_Measurements_Detail
Fair Value Measurements (Details) (Recurring, Level I, Money market funds, USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Millions, unless otherwise specified | ||
Recurring | Level I | Money market funds | ||
Fair value measurements | ||
Financial Assets | $33.20 | $70 |
Fair_Value_Measurements_Detail1
Fair Value Measurements (Details 2) (USD $) | 1 Months Ended | 12 Months Ended | |
In Thousands, unless otherwise specified | Jun. 30, 2013 | Dec. 31, 2013 | Dec. 31, 2012 |
Preferred stock liability | |||
Changes in the fair value of the Company's Level 3 financial liabilities | |||
Settlement of preferred stock | ($2,700) | ||
Recurring | Level 3 | |||
Changes in the fair value of the Company's Level 3 financial liabilities | |||
Beginning balance | 583 | ||
Ending balance | 583 | ||
Recurring | Level 3 | Preferred stock liability | |||
Changes in the fair value of the Company's Level 3 financial liabilities | |||
Change in fair value of preferred stock liability recorded as other expense, net | 2,070 | ||
Settlement of preferred stock | -2,653 | ||
Recurring | Level 3 | Preferred stock warrant liability | |||
Changes in the fair value of the Company's Level 3 financial liabilities | |||
Fair value of liability | 175 | ||
Change in fair value of preferred stock liability recorded as other expense, net | 86 | ||
Conversion of preferred stock warrant liability | ($261) |
Fair_Value_Measurements_Detail2
Fair Value Measurements (Details 3) (USD $) | 12 Months Ended | 0 Months Ended | 1 Months Ended | |||
Dec. 31, 2013 | Dec. 31, 2012 | Jun. 17, 2013 | Nov. 30, 2012 | Nov. 03, 2013 | Jun. 30, 2013 | |
Fair value measurements | ||||||
Change in value of preferred stock liability | $2,070,000 | ($278,000) | ||||
Series C | ||||||
Assumptions used to calculate fair value of preferred stock liability using the option-pricing method | ||||||
Estimated fair value common stock (in dollars per share) | $2.39 | $1.78 | $13.14 | $2.40 | ||
Preferred stock liability | ||||||
Fair value measurements | ||||||
Fair value of liability | 600,000 | 2,700,000 | 900,000 | |||
Change in value of preferred stock liability | ($300,000) | $2,100,000 | ||||
Assumptions used to calculate fair value of preferred stock liability using the option-pricing method | ||||||
Probability of success of the second tranche (as a percent) | 100.00% | 100.00% | ||||
Term | 1 day | 8 months 1 day | ||||
Expected volatility (as a percent) | 36.40% | 44.00% |
Commitments_and_Contingencies_1
Commitments and Contingencies (Details) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
item | |||
Operating Leases | |||
Restricted cash | $118,000 | $118,000 | |
Future minimum lease payments under non-cancelable operating leases | |||
2015 | 989,000 | ||
2016 | 413,000 | ||
2017 | 222,000 | ||
2018 | 130,000 | ||
Total minimum lease payments | 1,754,000 | ||
Facilities rent expense | 852,000 | 840,000 | 711,000 |
Supplies Purchase Commitments | |||
Number of suppliers with which Company has non-cancelable purchase commitment | 2 | ||
Non-cancelable purchase commitment | 715,000 | ||
Laboratory facilities, Austin, Texas | |||
Operating Leases | |||
Cash security deposit | $75,000 | $75,000 |
Debt_Details
Debt (Details) (USD $) | 1 Months Ended | 12 Months Ended | 1 Months Ended | ||||||
Jun. 30, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2014 | Nov. 30, 2013 | Nov. 03, 2013 | Dec. 01, 2014 | Nov. 30, 2014 | Mar. 31, 2014 | |
installment | |||||||||
tranche | |||||||||
Debt | |||||||||
Amount drawn down | $5,000,000 | ||||||||
Cash paid for interest on debt | 307,000 | 132,000 | |||||||
Long-term debt, net of current portion | 4,923,000 | 4,899,000 | 4,923,000 | ||||||
Interest expense on debt | |||||||||
Total | 81,000 | 42,000 | |||||||
Convertible Preferred Stock Warrants | |||||||||
Interest expense on debt | |||||||||
Exercise price of warrant to purchase shares of Series C convertible preferred stock (in dollars per share) | $7.56 | $7.56 | |||||||
Number of shares for which warrant became exercisable | 24,801 | ||||||||
Aggregate fair value of the warrant for the shares exercisable under the warrant | 175,000 | 261,000 | |||||||
Amortization period of debt discount | 48 months | ||||||||
Term Loans | |||||||||
Debt | |||||||||
Maximum borrowing capacity | 10,000,000 | 15,000,000 | 15,000,000 | ||||||
Amount not drawn | 5,000,000 | ||||||||
Number of installments | 24 | 24 | |||||||
Period after which debt is repayable | 24 months | ||||||||
Prepayment penalties for prepayment within one year of the loan origination (as a percent) | 2.00% | ||||||||
Prepayment penalties for prepayment within two years of the loan origination (as a percent) | 1.00% | ||||||||
Prepayment penalties for prepayment after two years of the loan origination (as a percent) | 0.00% | ||||||||
Number of tranches | 3 | 3 | |||||||
Cash paid for interest on debt | 14,000 | ||||||||
End-of term payment | 110,000 | ||||||||
Amount of prepayment premium waived | 75,000 | ||||||||
Amount of end of term payment | 237,500 | 237,500 | 110,000 | 225,000 | |||||
Third-party fees paid | 45,000 | ||||||||
Debt and unpaid accrued end-of-term payment | 5,003,000 | 5,042,000 | 5,003,000 | ||||||
Unamortized note discount | -80,000 | -143,000 | -80,000 | ||||||
Net debt obligation | 4,923,000 | 4,899,000 | 4,923,000 | ||||||
Future principal payments | |||||||||
2017 | 2,437,000 | 2,437,000 | |||||||
2018 | 2,563,000 | 2,563,000 | |||||||
Total | 5,000,000 | 5,000,000 | |||||||
Interest expense on debt | |||||||||
End of term payment as a percentage of total outstanding principal balance | 4.75% | ||||||||
Nominal interest | 296,000 | 158,000 | |||||||
Amortization of debt discount | 62,000 | 33,000 | |||||||
End of term payment interest | 81,000 | 42,000 | |||||||
Total | 439,000 | 233,000 | |||||||
Term Loans | Term Loan Due 2017 | |||||||||
Debt | |||||||||
Amount drawn down | 5,000,000 | ||||||||
Number of installments | 30 | ||||||||
Period after which debt is repayable | 18 months | ||||||||
Interest rate (as a percent) | 6.06% | ||||||||
Prepayment penalties for prepayment within one year of the loan origination (as a percent) | 2.25% | ||||||||
Prepayment penalties for prepayment within two years of the loan origination (as a percent) | 1.50% | ||||||||
Prepayment penalties for prepayment after two years of the loan origination (as a percent) | 0.75% | ||||||||
Repayment of debt | 5,000,000 | ||||||||
Term Loans | Term Loan Tranche One | |||||||||
Debt | |||||||||
Maximum borrowing capacity | 5,000,000 | 5,000,000 | |||||||
Amount drawn down | 5,000,000 | ||||||||
Interest rate (as a percent) | 5.00% | 5.00% | |||||||
Term Loans | Term Loan Tranche Two | |||||||||
Debt | |||||||||
Maximum borrowing capacity | 5,000,000 | 5,000,000 | |||||||
Amount drawn down | 5,000,000 | ||||||||
Term Loans | Term Loan Tranche Three | |||||||||
Debt | |||||||||
Maximum borrowing capacity | $5,000,000 | $5,000,000 |
Convertible_Preferred_Stock_Wa1
Convertible Preferred Stock Warrant (Details) (USD $) | 1 Months Ended | 12 Months Ended | 0 Months Ended | 1 Months Ended | |||
Jun. 30, 2013 | Dec. 31, 2013 | Nov. 03, 2013 | Mar. 31, 2014 | Jun. 17, 2013 | Nov. 30, 2012 | Nov. 30, 2013 | |
Convertible preferred stock warrant | |||||||
Amount drawn down on term loan | $5,000,000 | ||||||
Assumptions used to calculate fair value of warrant upon issuance using Black-Scholes option-pricing valuation model | |||||||
Amount of change in the fair value reported as an expense in other income (expense), net | 86,000 | ||||||
Series C | |||||||
Assumptions used to calculate fair value of warrant upon issuance using Black-Scholes option-pricing valuation model | |||||||
Estimated fair value common stock (in dollars per share) | $2.40 | $13.14 | $2.39 | $1.78 | |||
Convertible Preferred Stock Warrants | |||||||
Convertible preferred stock warrant | |||||||
Number of shares of preferred stock that can be purchased by each warrant | 49,602 | ||||||
Exercise price of warrant to purchase shares of Series C convertible preferred stock (in dollars per share) | $7.56 | $7.56 | |||||
Number of shares for which warrant became exercisable | 24,801 | 24,801 | |||||
Number of warrants exercised | 24,801 | ||||||
Issuance of common stock on cashless exercise of warrant (in shares) | 13,739 | ||||||
Fair value of currently exercisable portion of the warrant | 175,000 | 261,000 | |||||
Assumptions used to calculate fair value of warrant upon issuance using Black-Scholes option-pricing valuation model | |||||||
Contractual term | 7 years 3 months 18 days | 7 years | |||||
Risk-free interest rate (as a percent) | 2.10% | 2.00% | |||||
Expected volatility (as a percent) | 73.70% | 81.40% | |||||
Expected dividend yield (as a percent) | 0.00% | 0.00% | |||||
Amount of change in the fair value reported as an expense in other income (expense), net | $86,000 |
Convertible_Preferred_Stock_De
Convertible Preferred Stock (Details) (USD $) | 12 Months Ended | 0 Months Ended | 1 Months Ended | 0 Months Ended | ||||
Dec. 31, 2013 | Dec. 31, 2012 | Jun. 17, 2013 | Jun. 30, 2013 | Nov. 30, 2012 | Nov. 04, 2013 | Dec. 31, 2014 | Nov. 03, 2013 | |
Convertible preferred stock | ||||||||
Preferred stock liability valuation decrease recorded in other income (expense), net | ($2,070,000) | $278,000 | ||||||
Preferred stock liability | ||||||||
Assumptions used to calculate fair value of preferred stock liability using the option-pricing method | ||||||||
Probability of success of the second tranche (as a percent) | 100.00% | 100.00% | ||||||
Contractual term | 1 day | 8 months 1 day | ||||||
Expected volatility (as a percent) | 36.40% | 44.00% | ||||||
Convertible preferred stock | ||||||||
Preferred stock liability | 600,000 | 2,700,000 | 900,000 | |||||
Preferred stock liability valuation decrease recorded in other income (expense), net | 300,000 | -2,100,000 | ||||||
Preferred stock liability settled | ($2,700,000) | |||||||
Common Stock | ||||||||
Assumptions used to calculate fair value of preferred stock liability using the option-pricing method | ||||||||
Estimated fair value common stock (in dollars per share) | $14.50 | $13 | $9.66 | |||||
Convertible preferred stock | ||||||||
Conversion of preferred stock into common stock upon initial public offering (in shares) | 14,997,312 | 14,997,312 | ||||||
Convertible Preferred Stock. | ||||||||
Convertible preferred stock | ||||||||
Convertible preferred stock converted to common stock (in shares) | 59,989,268 | |||||||
Conversion of preferred stock into common stock upon initial public offering (in shares) | -59,989,268 | |||||||
Series C | ||||||||
Assumptions used to calculate fair value of preferred stock liability using the option-pricing method | ||||||||
Estimated fair value common stock (in dollars per share) | $2.39 | $2.40 | $1.78 | $13.14 |
Stockholders_Equity_Details
Stockholders' Equity (Details) (USD $) | 12 Months Ended | ||||
Dec. 31, 2014 | Dec. 31, 2013 | Nov. 04, 2013 | Dec. 31, 2012 | Dec. 31, 2011 | |
Vote | |||||
Stockholders' Equity | |||||
Authorized shares of common stock | 125,000,000 | 125,000,000 | |||
Par value of shares of common stock (in dollars per share) | $0.00 | $0.00 | |||
Number of votes for each share of stock | 1 | ||||
Dividends declared | $0 | ||||
Common Stock | |||||
Options issued and outstanding (in shares) | 3,249,469 | 2,359,287 | 2,227,669 | 1,429,737 | |
Options available for grant under stock option plans (in shares) | 1,341,252 | 1,787,802 | 347,386 | 474,961 | |
Shares of common stock reserved for issuance | 4,590,721 | 4,171,890 | |||
Preferred stock, shares authorized | 5,000,000 | 5,000,000 | 5,000,000 | ||
Preferred stock, par value (in dollars per share) | $0.00 | $0.00 | $0.00 | ||
Preferred stock, shares issued | 0 | 0 | |||
Preferred stock, shares outstanding | 0 | 0 | |||
Options | |||||
Common Stock | |||||
Options issued and outstanding (in shares) | 3,249,469 | 2,359,287 | |||
Options available for grant under stock option plans (in shares) | 1,341,252 | 1,787,802 | |||
Common Stock Warrants | |||||
Common Stock | |||||
Common stock warrants issued and outstanding (in shares) | 24,801 |
Stock_Incentive_Plans_Details
Stock Incentive Plans (Details) | 0 Months Ended | 12 Months Ended | ||||
Feb. 15, 2008 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 | Oct. 02, 2013 | |
Stock incentive plans | ||||||
Number of shares available for issuance | 1,341,252 | 1,787,802 | 347,386 | 474,961 | ||
Options | ||||||
Stock incentive plans | ||||||
Number of shares available for issuance | 1,341,252 | 1,787,802 | ||||
2008 Plan | Options | Minimum | ||||||
Stock incentive plans | ||||||
Exercise price of options granted expressed as a percentage of its fair value | 100.00% | |||||
2008 Plan | Options | Maximum | ||||||
Stock incentive plans | ||||||
Term of options granted | 10 years | |||||
2008 Plan | Options | Newly hired employee | ||||||
Stock incentive plans | ||||||
Vesting period | 4 years | |||||
Percentage of award vesting after one year | 25.00% | |||||
2008 Plan | ISO | Minimum | ||||||
Stock incentive plans | ||||||
Voting power of person owning stock (as a percent) | 10.00% | |||||
Option price as a percentage of estimated fair value of shares on date of grant to a person owning stock representing more than 10% of voting power of all classes of stock | 110.00% | |||||
2008 Plan | ISO | Maximum | ||||||
Stock incentive plans | ||||||
Term of options granted to a person owning stock representing more than 10% of voting power of all classes of stock | 5 years | |||||
2013 Plan | ||||||
Stock incentive plans | ||||||
Number of additional shares reserved for issuance | 1,700,000 | |||||
Maximum annual increase in outstanding shares on the last day of the immediately preceding fiscal year (as a percent) | 4.00% | |||||
Number of shares available for issuance | 1,341,252 | |||||
2013 Plan | Options | Outside director serving as a member of Board of Directors for at least six months | ||||||
Stock incentive plans | ||||||
Shares granted as annual grant | 10,000 | |||||
2013 Plan | Options | Outside director serving as a member of Board of Directors for at least six months | Minimum | ||||||
Stock incentive plans | ||||||
Period for which director has to serve as board of director to receive grant to purchase shares | 6 months | |||||
2013 Plan | Options | Outside director | ||||||
Stock incentive plans | ||||||
Exercise price of options granted expressed as a percentage of its fair value | 100.00% | |||||
2013 Plan | Options | Outside director | Maximum | ||||||
Stock incentive plans | ||||||
Expiration period after termination of service | 12 months | |||||
2013 Plan | ISO | Minimum | ||||||
Stock incentive plans | ||||||
Exercise price of options granted expressed as a percentage of its fair value | 100.00% | |||||
2013 Plan | ISO | Maximum | ||||||
Stock incentive plans | ||||||
Term of options granted | 10 years | |||||
2013 Plan | NSO | Minimum | ||||||
Stock incentive plans | ||||||
Exercise price of options granted expressed as a percentage of its fair value | 100.00% | |||||
2013 Plan | NSO | Outside director who was not previously an employee | ||||||
Stock incentive plans | ||||||
Percentage of award vesting after one year | 25.00% | |||||
Shares granted as initial grant | 35,000 | |||||
Percentage of award granted which vests on a monthly basis | 0.75 | |||||
Period over which remaining shares will vest on a monthly basis | 3 years |
Stock_Incentive_Plans_Details_
Stock Incentive Plans (Details 2) (USD $) | 12 Months Ended | ||||
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 | Nov. 04, 2013 |
Shares Available for Grant | |||||
Balance at the beginning of the period (in shares) | 1,787,802 | 347,386 | 474,961 | ||
Additional options authorized (in shares) | 845,732 | 1,950,000 | 743,100 | ||
Granted (in shares) | -1,488,492 | -695,029 | -931,944 | ||
Canceled (in shares) | 196,210 | 185,445 | 61,269 | ||
Balance at the end of the period (in shares) | 1,341,252 | 1,787,802 | 347,386 | 474,961 | |
Stock Options Outstanding | |||||
Balance at beginning of the period (in shares) | 2,359,287 | 2,227,669 | 1,429,737 | ||
Granted (in shares) | 1,488,492 | 695,029 | 931,944 | ||
Canceled (in shares) | -196,210 | -185,445 | -61,269 | ||
Exercised (in shares) | -402,100 | -377,966 | -72,743 | ||
Balance at the end of the period (in shares) | 3,249,469 | 2,359,287 | 2,227,669 | 1,429,737 | |
Options vested and exercisable at the end of the period (in shares) | 1,370,944 | ||||
Options vested and expected to vest at the end of the period (in shares) | 3,092,476 | ||||
Weighted Average Exercise Price | |||||
Balance at beginning of the period (in dollars per share) | $3.07 | $2.06 | $1.55 | ||
Granted (in dollars per share) | $13.38 | $5.32 | $2.78 | ||
Canceled (in dollars per share) | $9.37 | $2.69 | $1.97 | ||
Exercised (in dollars per share) | $1.68 | $1.46 | $1.05 | ||
Balance at the end of the period (in dollars per share) | $7.59 | $3.07 | $2.06 | $1.55 | |
Options vested and exercisable at the end of the period (in dollars per share) | $2.92 | ||||
Options vested and expected to vest at the end of the period (in dollars per share) | $7.32 | ||||
Weighted Average Remaining Contractual Life | |||||
Balance at the beginning of the period | 7 years 10 months 17 days | 7 years 10 months 2 days | 8 years 2 months 1 day | 8 years 2 months 19 days | |
Balance at the end of the period | 7 years 10 months 17 days | 7 years 10 months 2 days | 8 years 2 months 1 day | 8 years 2 months 19 days | |
Options vested and exercisable at the end of the period | 6 years 5 months 9 days | ||||
Options vested and expected to vest at the end of the period | 7 years 9 months 22 days | ||||
Aggregate Intrinsic Value | |||||
Balance at the beginning of the period (in dollars) | $26,964 | $4,311 | $1,221 | ||
Balance at the end of the period (in dollars) | 12,400 | 26,964 | 4,311 | 1,221 | |
Options vested and exercisable at the end of the period (in dollars) | 9,287 | ||||
Options vested and expected to vest at the end of the period (in dollars) | $12,295 | ||||
Common Stock | |||||
Stock Options Outstanding | |||||
Exercised (in shares) | -402,100 | -377,966 | -72,743 | ||
Additional disclosures | |||||
Estimated fair value common stock (in dollars per share) | $9.66 | $14.50 | $13 |
Stock_Incentive_Plans_Details_1
Stock Incentive Plans (Details 3) (USD $) | 12 Months Ended | ||
In Millions, except Per Share data, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Stock Incentive Plans | |||
Weighted average fair value of options to purchase common stock granted (in dollars per share) | $9.08 | $4.19 | $1.95 |
Weighted average fair value of vested options (in dollars per share) | $3.07 | $2.12 | $1.40 |
Stock incentive plans | |||
Weighted average fair value of stock options exercised (in dollars per share) | $1.18 | $0.97 | |
Intrinsic value of stock options exercised (in dollars) | $3.20 | $4.90 | $0.20 |
Employee stock options | |||
Stock incentive plans | |||
Total estimated grant date fair value of options to purchase common stock vested (in dollars) | $1.60 | $1.30 |
Stock_Incentive_Plans_Details_2
Stock Incentive Plans (Details 4) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Stock-based Compensation | |||
Stock-based compensation | |||
Share-based compensation expense (in dollars) | $3,548,000 | $1,247,000 | $675,000 |
Unrecognized compensation expense (in dollars) | 9,900,000 | ||
Period over which unrecognized compensation expense expected to be recognized | 3 years | ||
Stock-based Compensation | Cost of revenue | |||
Stock-based compensation | |||
Share-based compensation expense (in dollars) | 51,000 | 34,000 | 26,000 |
Stock-based Compensation | Research and development | |||
Stock-based compensation | |||
Share-based compensation expense (in dollars) | 790,000 | 250,000 | 131,000 |
Stock-based Compensation | Selling and marketing | |||
Stock-based compensation | |||
Share-based compensation expense (in dollars) | 707,000 | 169,000 | 111,000 |
Stock-based Compensation | General and administrative | |||
Stock-based compensation | |||
Share-based compensation expense (in dollars) | $2,000,000 | $794,000 | $407,000 |
Stock-based Compensation, employees | |||
Assumptions used to calculate estimated fair value of stock options using the Black-Scholes option-pricing valuation model | |||
Weighted-average volatility, low end of range (as a percent) | 70.19% | 80.42% | 82.07% |
Weighted-average volatility, high end of range (as a percent) | 78.54% | 81.41% | 84.33% |
Risk-free interest rate, low end of range (as a percent) | 1.66% | 0.88% | 0.65% |
Risk-free interest rate, high end of range (as a percent) | 2.04% | 2.11% | 1.19% |
Stock-based Compensation, employees | Minimum | |||
Assumptions used to calculate estimated fair value of stock options using the Black-Scholes option-pricing valuation model | |||
Weighted-average expected term | 5 years 6 months | 5 years | 5 years |
Stock-based Compensation, employees | Maximum | |||
Assumptions used to calculate estimated fair value of stock options using the Black-Scholes option-pricing valuation model | |||
Weighted-average expected term | 6 years 29 days | 6 years 29 days | 6 years 29 days |
Stock-based Compensation, non-employees | |||
Assumptions used to calculate estimated fair value of stock options using the Black-Scholes option-pricing valuation model | |||
Weighted-average volatility, low end of range (as a percent) | 73.20% | 77.86% | 81.14% |
Weighted-average volatility, high end of range (as a percent) | 74.48% | 78.14% | 82.11% |
Risk-free interest rate, low end of range (as a percent) | 2.09% | 2.59% | 1.43% |
Risk-free interest rate, high end of range (as a percent) | 2.20% | 2.99% | 1.77% |
Stock-based Compensation, non-employees | Minimum | |||
Assumptions used to calculate estimated fair value of stock options using the Black-Scholes option-pricing valuation model | |||
Weighted-average expected term | 8 years 9 months | 7 years 8 months 19 days | 8 years 2 months 23 days |
Stock-based Compensation, non-employees | Maximum | |||
Assumptions used to calculate estimated fair value of stock options using the Black-Scholes option-pricing valuation model | |||
Weighted-average expected term | 10 years | 9 years 9 months | 9 years 11 months 5 days |
Stock_Incentive_Plans_Details_3
Stock Incentive Plans (Details 5) (USD $) | 12 Months Ended | 1 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Feb. 28, 2013 | |
Stock-based compensation | ||||
Options granted (in shares) | 1,488,492 | 695,029 | 931,944 | |
Weighted average fair value of stock options vested (in dollars per share) | $3.07 | $2.12 | $1.40 | |
Equity-based Compensation, executive bonuses | ||||
Stock-based compensation | ||||
Options granted (in shares) | 100,498 | |||
Weighted average fair value of stock options vested (in dollars per share) | $2.59 | |||
Share-based compensation expense (in dollars) | $259,000 |
Genzyme_Copromotion_Agreement_
Genzyme Co-promotion Agreement (Details) (USD $) | 12 Months Ended | 0 Months Ended | 1 Months Ended | 7 Months Ended | 10 Months Ended | 14 Months Ended | 2 Months Ended | ||||||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Jan. 01, 2015 | Aug. 12, 2014 | Feb. 29, 2012 | Aug. 11, 2014 | Dec. 31, 2014 | Feb. 27, 2014 | Jan. 31, 2015 | Jan. 31, 2012 | Nov. 07, 2014 | Feb. 13, 2015 | |
country | country | country | |||||||||||
Genzyme Co-promotion Agreement | |||||||||||||
Co-promotion fee received from Genzyme | $10,000,000 | ||||||||||||
Amortization of up-front co-promotion fee | 2,269,000 | 2,500,000 | 2,386,000 | ||||||||||
Co-promotion agreement | Genzyme | |||||||||||||
Genzyme Co-promotion Agreement | |||||||||||||
Co-promotion expenses | 12,000,000 | 8,600,000 | 5,500,000 | ||||||||||
Outstanding obligation to Genzyme | 6,000,000 | 6,700,000 | 6,000,000 | ||||||||||
Amortization of up-front co-promotion fee | 2,300,000 | 2,500,000 | 2,400,000 | ||||||||||
Co-promotion agreement | Genzyme | Accounts payable | |||||||||||||
Genzyme Co-promotion Agreement | |||||||||||||
Outstanding obligation to Genzyme | 2,700,000 | 1,800,000 | 2,700,000 | ||||||||||
Co-promotion agreement | Genzyme | Accrued liabilities | |||||||||||||
Genzyme Co-promotion Agreement | |||||||||||||
Outstanding obligation to Genzyme | 3,300,000 | 4,900,000 | 3,300,000 | ||||||||||
Afirma thyroid diagnostic solution co-promotion agreement | Genzyme | |||||||||||||
Genzyme Co-promotion Agreement | |||||||||||||
Number of countries outside United States for exclusive promotion under the agreement | 40 | ||||||||||||
Co-promotion fee received from Genzyme | 10,000,000 | ||||||||||||
Co-promotion fees as a percentage of cash receipts | 50.00% | 32.00% | 40.00% | ||||||||||
Maximum amount to be spent by co-promoter for qualifying clinical development activities in countries that require additional testing | $500,000 | ||||||||||||
Co-promotion fees as a percentage of cash receipts for remaining periods | 15.00% | ||||||||||||
Amortization period of co-promotion fee | 4 years | ||||||||||||
Termination notification period | 6 months | ||||||||||||
Ex-U.S. Co-Promotion Agreement | Genzyme | |||||||||||||
Genzyme Co-promotion Agreement | |||||||||||||
Number of countries outside United States for exclusive promotion under the agreement | 6 | ||||||||||||
Co-promotion fees as a percentage of cash receipts | 32.00% | ||||||||||||
Ex-U.S. Co-Promotion Agreement | Genzyme | Subsequent Event | |||||||||||||
Genzyme Co-promotion Agreement | |||||||||||||
Number of countries outside United States for exclusive promotion under the agreement | 5 |
Thyroid_Cytopathology_Partners1
Thyroid Cytopathology Partners (Details) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Thyroid Cytopathology Partners | |||
Outstanding obligations | $7,397,000 | $5,294,000 | |
Thyroid Cytopathology Partners | |||
Thyroid Cytopathology Partners | |||
Notice of intent not to renew period | 12 months | ||
Expenses for cytopathology testing and evaluation services | 4,000,000 | 3,200,000 | 1,800,000 |
Outstanding obligations | 1,100,000 | 600,000 | |
Reduction to rent expense for TCP's portion of costs for shared space | 86,000 | 49,000 | |
Reimbursed rent | 59,000 | ||
Excess payment included in accounts payable | $10,000 |
Income_Taxes_Details
Income Taxes (Details) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Income Taxes | |||
Pretax loss | $29,400,000 | $25,600,000 | $18,600,000 |
Reconciliation of tax expense computed at the statutory federal rate and the Company's tax expense | |||
U.S. federal taxes at statutory rate | -9,987,000 | -8,697,000 | -6,341,000 |
State taxes (net of federal benefit) | 5,000 | 11,000 | -1,074,000 |
Permanent differences | 64,000 | 790,000 | -23,000 |
Incentive stock options | 672,000 | 355,000 | 284,000 |
Tax credits | -461,000 | -502,000 | -113,000 |
Change in valuation allowance | 9,707,000 | 8,043,000 | 7,267,000 |
Current deferred tax assets: | |||
Genzyme co-promotion agreement | 793,000 | 1,005,000 | 1,001,000 |
Accruals and deferred rent | 1,819,000 | 599,000 | 148,000 |
Gross deferred tax assets | 2,612,000 | 1,604,000 | 1,149,000 |
Valuation allowance | -2,312,000 | -1,603,000 | -1,145,000 |
Net deferred tax assets | 300,000 | 1,000 | 4,000 |
Non-current deferred tax assets: | |||
Net operating loss carryforwards | 41,971,000 | 28,569,000 | 20,536,000 |
Research and development credits | 1,916,000 | 1,455,000 | 954,000 |
Stock-based compensation | 826,000 | 313,000 | 154,000 |
Genzyme co-promotion agreement | 202,000 | 787,000 | 2,048,000 |
Accruals, deferred rent and other | 1,562,000 | 106,000 | 9,000 |
Gross deferred tax assets | 46,477,000 | 31,230,000 | 23,701,000 |
Valuation allowance | -41,127,000 | -31,216,000 | -23,622,000 |
Net deferred tax assets | 5,350,000 | 14,000 | 79,000 |
Deferred tax liabilities: | |||
Property and equipment | -60,000 | -15,000 | -83,000 |
In-process research and development | -5,590,000 | ||
Gross deferred tax liabilities | -5,650,000 | -15,000 | -83,000 |
Net non-current deferred tax liabilities | -300,000 | -1,000 | -4,000 |
Increase in valuation allowance against deferred tax assets | 10,600,000 | 8,100,000 | |
Operating loss carryforwards | |||
Federal and state net operating loss carryforwards related to stock-based compensation | 200,000 | ||
Federal | |||
Operating loss carryforwards | |||
Net operating loss carryforwards | 113,600,000 | ||
State | |||
Operating loss carryforwards | |||
Net operating loss carryforwards | $60,600,000 |
Income_Taxes_Details_2
Income Taxes (Details 2) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Reconciliation of the beginning and ending amount of unrecognized tax benefits | |||
Unrecognized tax benefits, beginning of period | $727,000 | $481,000 | $341,000 |
Gross increases-tax position in prior period | 548,000 | 68,000 | 67,000 |
Gross increases-current period tax positions | 296,000 | 178,000 | 73,000 |
Unrecognized tax benefits, end of period | 1,571,000 | 727,000 | 481,000 |
Interest expense or penalties related to unrecognized tax benefits | 0 | ||
Federal | |||
Credit carryforwards | |||
Credit carryforwards available to reduce future taxable income | 2,200,000 | ||
State | |||
Credit carryforwards | |||
Credit carryforwards available to reduce future taxable income | $1,600,000 |
Income_Taxes_Details_3
Income Taxes (Details 3) | 12 Months Ended |
Dec. 31, 2014 | |
Federal | |
Income tax examination | |
Income tax examination period | 3 years |
State | |
Income tax examination | |
Income tax examination period | 4 years |
401k_Plan_Details
401(k) Plan (Details) (USD $) | 12 Months Ended | |
Dec. 31, 2014 | Dec. 31, 2013 | |
401(k) Plan | ||
Employer contributions to the plan | $0 | $0 |
Selected_Quarterly_Financial_D2
Selected Quarterly Financial Data (Unaudited) (Details) (USD $) | 3 Months Ended | 12 Months Ended | |||||||||
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2013 | Sep. 30, 2013 | Jun. 30, 2013 | Mar. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Selected Quarterly Financial Data (Unaudited) | |||||||||||
Total revenues | $12,199 | $9,838 | $8,677 | $7,476 | $6,838 | $5,594 | $5,068 | $4,384 | $38,190 | $21,884 | $11,628 |
Net loss | ($8,142) | ($7,902) | ($6,655) | ($6,674) | ($5,892) | ($6,303) | ($6,490) | ($6,895) | ($29,373) | ($25,580) | ($18,649) |
Net loss per common share, basic and diluted | ($0.36) | ($0.37) | ($0.31) | ($0.32) | ($0.42) | ($6.59) | ($7.53) | ($9.04) | ($1.36) | ($6.15) | ($28.68) |
Shares used to compute net loss per common share, basic and diluted (in shares) | 22,508,250 | 21,648,660 | 21,237,196 | 21,148,342 | 13,944,239 | 955,890 | 861,839 | 763,021 | 21,639,374 | 4,158,664 | 650,333 |
Subsequent_Event_Unaudited_Det
Subsequent Event (Unaudited) (Details) (Ex-U.S. Co-Promotion Agreement, Genzyme) | 0 Months Ended | ||
Jan. 01, 2015 | Nov. 07, 2014 | Feb. 13, 2015 | |
country | country | ||
Subsequent Events | |||
Number of countries outside United States for exclusive promotion under the agreement | 6 | ||
Subsequent Event | |||
Subsequent Events | |||
Number of countries outside United States for exclusive promotion under the agreement | 5 | ||
Co-promotion fee paid as a percentage of net revenue | 25.00% | ||
Period of agreement | 5 years |