Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2019 | May 06, 2019 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | CDNA | |
Entity Registrant Name | CareDx, Inc. | |
Entity Central Index Key | 0001217234 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Common Stock, Shares Outstanding | 42,119,913 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 57,432 | $ 64,616 |
Accounts receivable | 12,525 | 9,760 |
Inventory | 5,177 | 4,943 |
Prepaid and other current assets | 2,444 | 1,795 |
Total current assets | 77,578 | 81,114 |
Property and equipment, net | 3,820 | 4,134 |
Operating leases right-of-use assets | 2,506 | 0 |
Intangible assets, net | 31,759 | 33,252 |
Goodwill | 12,005 | 12,005 |
Restricted cash | 191 | 192 |
Total assets | 127,859 | 130,697 |
Current liabilities: | ||
Accounts payable | 3,859 | 4,711 |
Accrued compensation | 4,860 | 9,156 |
Accrued and other liabilities | 7,651 | 5,637 |
Total current liabilities | 16,370 | 19,504 |
Deferred tax liability | 2,571 | 2,968 |
Common stock warrant liability | 10,521 | 10,003 |
Other liabilities | 2,775 | 2,294 |
Total liabilities | 32,237 | 34,769 |
Commitments and contingencies (Note 8) | 0 | 0 |
Stockholders’ equity: | ||
Preferred stock: $0.001 par value; 10,000,000 shares authorized at March 31, 2019 and December 31, 2018; no shares issued and outstanding at March 31, 2019 and December 31, 2018 | 0 | 0 |
Common stock: $0.001 par value; 100,000,000 shares authorized at March 31, 2019 and December 31, 2018; 41,912,469 shares and 41,384,960 shares issued and outstanding at March 31, 2019 and December 31, 2018, respectively | 41 | 41 |
Additional paid-in capital | 419,959 | 412,010 |
Accumulated other comprehensive loss | (5,002) | (4,278) |
Accumulated deficit | (319,376) | (311,845) |
Total stockholders' equity | 95,622 | 95,928 |
Total liabilities and stockholders’ equity | $ 127,859 | $ 130,697 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2019 | Dec. 31, 2018 |
Statement Of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 41,912,469 | 41,384,960 |
Common stock, shares outstanding | 41,912,469 | 41,384,960 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operation - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Revenue: | ||
Total revenue | $ 25,982 | $ 14,053 |
Operating expenses: | ||
Research and development | 5,614 | 3,368 |
Sales and marketing | 6,925 | 4,085 |
General and administrative | 9,106 | 5,307 |
Change in estimated fair value of contingent consideration | 144 | |
Total operating expenses | 31,378 | 19,288 |
Loss from operations | (5,396) | (5,235) |
Other income (expense): | ||
Interest income (expense), net | 342 | (2,695) |
Debt extinguishment expenses | (2,806) | |
Change in estimated fair value of common stock warrant liability and derivative liability | (3,009) | 1,321 |
Other expense, net | (74) | (3) |
Total other income (expense) | (2,741) | (4,183) |
Loss before income taxes | (8,137) | (9,418) |
Income tax benefit | 606 | 424 |
Net loss | (7,531) | (8,994) |
Net loss attributable to noncontrolling interest | (25) | |
Net loss attributable to CareDx, Inc. | $ (7,531) | $ (8,969) |
Net loss per share attributable to CareDx, Inc. (Note 3): | ||
Basic | $ (0.18) | $ (0.30) |
Diluted | $ (0.18) | $ (0.30) |
Weighted-average shares used to compute net loss per share attributable to CareDx, Inc.: | ||
Basic | 41,611,399 | 29,615,441 |
Diluted | 41,611,399 | 29,615,441 |
Testing Services [Member] | ||
Revenue: | ||
Total revenue | $ 21,518 | $ 10,604 |
Operating expenses: | ||
Cost of testing services and product | 6,838 | 4,112 |
Product [Member] | ||
Revenue: | ||
Total revenue | 4,433 | 3,307 |
Operating expenses: | ||
Cost of testing services and product | 2,895 | 2,272 |
License and Other [Member] | ||
Revenue: | ||
Total revenue | $ 31 | $ 142 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Statement Of Income And Comprehensive Income [Abstract] | ||
Net loss | $ (7,531) | $ (8,994) |
Other comprehensive loss: | ||
Foreign currency translation adjustments | (724) | (137) |
Net comprehensive loss | (8,255) | (9,131) |
Comprehensive loss attributable to noncontrolling interest, net of tax | 0 | (25) |
Comprehensive loss attributable to CareDx, Inc. | $ (8,255) | $ (9,106) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stock and Stockholders' Equity (Unaudited) - USD ($) $ in Thousands | Total | Employee [Member] | Non-Employee [Member] | Common Stock [Member] | Common Stock [Member]Employee [Member] | Common Stock [Member]Non-Employee [Member] | Additional Paid-in Capital [Member] | Additional Paid-in Capital [Member]Employee [Member] | Additional Paid-in Capital [Member]Non-Employee [Member] | Accumulated Other Comprehensive Loss [Member] | Accumulated Other Comprehensive Loss [Member]Employee [Member] | Accumulated Other Comprehensive Loss [Member]Non-Employee [Member] | Accumulated Deficit [Member] | Accumulated Deficit [Member]Employee [Member] | Accumulated Deficit [Member]Non-Employee [Member] | Noncontrolling Interest [Member] | Noncontrolling Interest [Member]Employee [Member] | Noncontrolling Interest [Member]Non-Employee [Member] |
Beginning Balance at Dec. 31, 2017 | $ (5,954) | $ 29 | $ 264,204 | $ (2,345) | $ (268,022) | $ 180 | ||||||||||||
Beginning Balance, Shares at Dec. 31, 2017 | 28,825,019 | |||||||||||||||||
Adoption of ASC 606 | ASU 2014-09 [Member] | 2,933 | $ 0 | 0 | 0 | 2,933 | 0 | ||||||||||||
Reclassification of warrants from liability to equity | 6,550 | 0 | 6,550 | 0 | 0 | 0 | ||||||||||||
Conversion of convertible debt | 38,854 | $ 6 | 38,848 | 0 | 0 | 0 | ||||||||||||
Conversion of convertible debt, Shares | 6,161,331 | |||||||||||||||||
Issuance of common stock under ESPP | 32 | $ 0 | 32 | 0 | 0 | 0 | ||||||||||||
Issuance of common stock under ESPP shares | 34,176 | |||||||||||||||||
RSU settlements, net of shares withheld | (128) | $ 0 | (128) | 0 | 0 | 0 | ||||||||||||
RSU settlements, net of shares withheld shares | 49,330 | |||||||||||||||||
Issuance of common stock for services | 62 | $ 0 | 62 | 0 | 0 | 0 | ||||||||||||
Issuance of common stock for services, Shares | 5,772 | |||||||||||||||||
Issuance of common stock for cash upon exercise of stock options | 80 | $ 0 | 80 | 0 | 0 | 0 | ||||||||||||
Issuance of common stock for cash upon exercise of stock options, Shares | 142,554 | |||||||||||||||||
Issuance of common stock for cash upon exercise of warrants | 153 | $ 0 | 153 | 0 | 0 | 0 | ||||||||||||
Issuance of common stock for cash upon exercise of warrants, Shares | 22,600 | |||||||||||||||||
Employee and non-employee share-based compensation expense | $ 573 | $ 61 | $ 0 | $ 0 | $ 573 | $ 61 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | ||||||
Noncontrolling interests upon acquisition | (692) | $ 0 | (537) | 0 | 0 | (155) | ||||||||||||
Foreign currency translation adjustment | (137) | 0 | 0 | (137) | 0 | 0 | ||||||||||||
Net loss | (8,994) | 0 | 0 | 0 | (8,969) | (25) | ||||||||||||
Ending Balance at Mar. 31, 2018 | 33,393 | $ 35 | 309,898 | (2,482) | (274,058) | 0 | ||||||||||||
Ending Balance, Shares at Mar. 31, 2018 | 35,240,782 | |||||||||||||||||
Beginning Balance at Dec. 31, 2017 | (5,954) | $ 29 | 264,204 | (2,345) | (268,022) | 180 | ||||||||||||
Beginning Balance, Shares at Dec. 31, 2017 | 28,825,019 | |||||||||||||||||
Ending Balance at Dec. 31, 2018 | 95,928 | $ 41 | 412,010 | (4,278) | (311,845) | 0 | ||||||||||||
Ending Balance, Shares at Dec. 31, 2018 | 41,384,960 | |||||||||||||||||
Issuance of common stock under ESPP | 341 | $ 0 | 341 | 0 | 0 | 0 | ||||||||||||
Issuance of common stock under ESPP shares | 31,184 | |||||||||||||||||
RSU settlements, net of shares withheld | (2,378) | $ 0 | (2,378) | 0 | 0 | 0 | ||||||||||||
RSU settlements, net of shares withheld shares | 146,159 | |||||||||||||||||
Issuance of common stock for services | 51 | $ 0 | 51 | 0 | 0 | 0 | ||||||||||||
Issuance of common stock for services, Shares | 2,112 | |||||||||||||||||
Issuance of common stock for cash upon exercise of stock options | $ 1,365 | $ 0 | 1,365 | 0 | 0 | 0 | ||||||||||||
Issuance of common stock for cash upon exercise of stock options, Shares | 251,739 | 253,347 | ||||||||||||||||
Issuance of common stock for cash upon exercise of warrants | $ 2,569 | $ 0 | 2,569 | 0 | 0 | 0 | ||||||||||||
Issuance of common stock for cash upon exercise of warrants, Shares | 94,707 | |||||||||||||||||
Employee and non-employee share-based compensation expense | $ 6,001 | $ 0 | $ 6,001 | $ 0 | $ 0 | $ 0 | ||||||||||||
Foreign currency translation adjustment | (724) | $ 0 | 0 | (724) | 0 | 0 | ||||||||||||
Net loss | (7,531) | 0 | 0 | 0 | (7,531) | 0 | ||||||||||||
Ending Balance at Mar. 31, 2019 | $ 95,622 | $ 41 | $ 419,959 | $ (5,002) | $ (319,376) | $ 0 | ||||||||||||
Ending Balance, Shares at Mar. 31, 2019 | 41,912,469 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Operating activities: | ||
Net loss | $ (7,531) | $ (8,994) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 1,161 | 1,039 |
Amortization of inventory fair market value adjustment | 164 | |
Loss on conversion of JGB Debt to shares of common stock | 2,806 | |
Amortization of debt discount and noncash interest expense | 2,084 | |
Revaluation of common stock warrant liability and derivative liability to estimated fair value | 3,009 | (1,321) |
Stock-based compensation | 6,053 | 706 |
Revaluation of contingent consideration to estimated fair value | 144 | |
Non-cash lease expense | 372 | |
Changes in operating assets and liabilities: | ||
Accounts receivable | (2,782) | (606) |
Inventory | (372) | 196 |
Prepaid and other assets | (541) | (510) |
Operating leases liabilities | (475) | |
Accounts payable | (449) | 835 |
Accrued compensation | (4,249) | (1,358) |
Accrued and other liabilities | 202 | 644 |
Change in deferred taxes | (265) | (347) |
Net cash used in operating activities | (5,867) | (4,518) |
Investing activities: | ||
Purchase of property and equipment | (543) | (62) |
Net cash used in investing activities | (543) | (754) |
Financing activities: | ||
Perceptive term loan issuance costs | (584) | |
Proceeds from issuance of common stock under employee stock purchase plan | 341 | 32 |
Taxes paid related to net share settlement of restricted stock units | (2,378) | |
Principal payments on debt and finance lease obligations | (42) | (1,633) |
Change in short term credit facility | (225) | |
Proceeds from exercise of warrants | 78 | 25 |
Proceeds from exercise of stock options | 1,365 | 80 |
Net cash used in financing activities | (688) | (2,318) |
Effect of exchange rate changes on cash and cash equivalents | (87) | 17 |
Net decrease in cash, cash equivalents and restricted cash | (7,185) | (7,573) |
Cash, cash equivalents, and restricted cash at beginning of period | 64,808 | 26,474 |
Cash, cash equivalents, and restricted cash at end of period | 57,623 | 18,901 |
Supplemental disclosure of cash flow information: | ||
Operating leases right-of-use assets | 2,506 | |
Allenex AB [Member] | ||
Investing activities: | ||
Acquisition of business and noncontrolling interests, net of cash acquired | (692) | |
Conexio [Member] | ||
Financing activities: | ||
Contingent payments related to the acquisition of Conexio Genomics Pty Ltd. | $ (52) | $ (13) |
Condensed Consolidated Statem_5
Condensed Consolidated Statements of Cash Flows (Parenthetical) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 | Mar. 31, 2018 | Dec. 31, 2017 |
Cash, Cash Equivalents and Restricted Cash as of: | ||||
Cash and cash equivalents | $ 57,432 | $ 64,616 | ||
Restricted cash | 191 | 192 | ||
Total cash, cash equivalents and restricted cash at the end of period | $ 57,623 | $ 64,808 | $ 18,901 | $ 26,474 |
Organization and Description of
Organization and Description of Business | 3 Months Ended |
Mar. 31, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Organization and Description of Business | 1. ORGANIZATION AND DESCRIPTION OF BUSINESS CareDx, Inc. (“CareDx” or the “Company”) together with its subsidiaries, is a global transplant diagnostics company with product offerings along the pre- and post-transplant continuum. The Company’s headquarters are in Brisbane, California. The primary operations are in Brisbane, U.S., Stockholm, Sweden and Fremantle, Australia. The Company focuses on discovery, development and commercialization of clinically differentiated, high-value diagnostic solutions for transplant patients. In diagnostic testing services, the Company offers AlloMap®, which is a gene expression solution for heart transplant patients and AlloSure®, which is a donor-derived cell-free DNA (“dd-cfDNA”) solution initially used for kidney transplant patients. The Company also offers high quality products that increase the chance of successful transplants by facilitating a better match between a donor and a recipient of stem cells and organs. Testing Services AlloMap is a covered service for Medicare beneficiaries since January 1, 2006. In 2018, the Medicare reimbursement rate for AlloMap was set at $3,240, which remains applicable for 2019. AlloMap has also received positive coverage decisions from many of the largest U.S. private payers. In October 2017, the Company commercially launched AlloSure, its proprietary next generation sequencing-based test that measures dd-cfDNA in kidney transplant recipients. The Medicare reimbursement rate for AlloSure is currently $2,841. AlloSure has also received payments from private payers on a case-by-case basis. However, no positive coverage decisions have yet been made for AlloSure. In September 2018, the Company initiated the Surveillance HeartCare® Outcomes Registry (“SHORE”). SHORE is a prospective, multi-center, observational, registry of patients receiving HeartCare for surveillance. HeartCare combines the gene expression profiling technology of AlloMap with the dd-cfDNA analysis of AlloSure-Heart® in one surveillance solution. AlloSure-Heart has not yet received positive coverage decisions from Medicare or other private payers. The Company has not yet made any applications to payers for reimbursement coverage of AlloSure-Heart. In February 2019, AlloSure-Lung® became available for lung transplant patients through a compassionate use program while the test is undergoing further studies. The Company has not yet made any applications to payers for reimbursement coverage of AlloSure-Lung. Products Olerup SSP® is used to type Human Leukocyte Antigen (“HLA”) alleles, based on the sequence specific primer (“SSP”) technology. Olerup SBT TM In May 2018, the Company entered into a License and Commercialization Agreement (the “License Agreement”) with Illumina, Inc. (“Illumina”), which provides the Company with worldwide distribution, development and commercialization rights to Illumina’s next generation sequencing (“NGS”) product line for use in transplantation diagnostic testing. Pursuant to the License Agreement, the Company is the exclusive worldwide distributor of Illumina’s TruSight ® Business Combination On April 25, 2019, the Company announced that it agreed to acquire OTTR Complete Transplant Management (“OTTR”). See Note 16 for further details. Liquidity The Company has incurred significant losses and negative cash flows from operations since its inception and had an accumulated deficit of $319.4 million at March 31, 2019. As of March 31, 2019, the Company had cash and cash equivalents of $57.4 million. The Company may req uire additional financing in the future to fund working capital and pay its obligations as they come due. Additional financing might include issuance of equity securities, debt, cash from collaboration agreements or a combination of these. However, there can be no assurance that the Company will be successful in acquiring additional funding at levels sufficient to fund its operations or on terms favorable to the Company. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES The significant accounting policies and estimates used in preparation of the unaudited condensed consolidated financial statements are described in the Company’s audited consolidated financial statements as of and for the year ended December 31, 2018, and the notes thereto, which are included in the Company’s Annual Report on Form 10-K. Material changes to the significant accounting policies previously disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018 are reflected below. Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”), and follow the requirements of the Securities and Exchange Commission (the “SEC”) for interim reporting. As permitted under those rules, certain footnotes and other financial information that are normally required by U.S. GAAP can be condensed or omitted. These unaudited condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments that are necessary for a fair statement of the Company’s financial information. The condensed consolidated balance sheet as of December 31, 2018 has been derived from audited consolidated financial statements as of that date but does not include all of the financial information required by U.S. GAAP for complete financial statements. Operating results for the three months ended March 31, 2019 are not necessarily indicative of the results that may be expected for the year ending December 31, 2019. The accompanying unaudited condensed consolidated financial statements include the accounts of the Company and its subsidiaries. Intercompany transactions have been eliminated. Reclassifications Certain prior year amounts have been reclassified to conform with the current year presentation, including separate presentation of debt extinguishment expenses from other expense, net. These reclassifications had no effect on the reported results of operations. Use of Estimates The preparation of unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities and the reported amounts of revenues and expenses in the unaudited condensed consolidated financial statements and accompanying notes. On an ongoing basis, management evaluates its estimates, including those related to transaction price estimates used for testing services revenue; accrued expenses for clinical studies; inventory valuation; the fair value of issued common stock warrants and embedded derivatives; the fair value of assets and liabilities acquired in a business combination or an assets acquisition (including identifiable intangible assets acquired); the fair value of contingent consideration recorded in connection with a business combination; the grant date fair value assumptions used to estimate stock-based compensation expense; income taxes; impairment of long-lived assets and indefinite-lived assets (including goodwill); and legal contingencies. Actual results could differ from those estimates. Concentrations of Credit Risk and Other Risks and Uncertainties For the three months ended March 31, 2019 and 2018, approximately 55% and 42%, respectively, of total revenue was derived from Medicare. No other payers or customers represented more than 10% of total revenue for these periods. As of March 31, 2019 and December 31, 2018, approximately 34% and 27%, respectively, of accounts receivable was due from Medicare. No other payer or customer represented more than 10% of accounts receivable on either March 31, 2019 or December 31, 2018. Leases Effective January 1, 2019, the Company adopted ASC Topic 842, Leases The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable; otherwise, the Company uses its incremental borrowing rate. The incremental borrowing rate is determined by using the rate of interest that the Company would pay to borrow on a collateralized basis an amount equal to the lease payments for a similar term and in a similar economic environment. The Company's leases have remaining terms of less than 1 year to 2.33 years, some of which include options to extend the lease term. The Company's lease terms may include renewal options that are reasonably certain to be exercised and termination options that are reasonably certain not to be exercised. Certain finance leases also include bargain purchase options of the leased equipment. Recent Accounting Pronouncements Effective January 1, 2019, the Company adopted ASC 842 using the optional transition method and applied the standard only to leases that existed at that date. Under the optional transition method, the Company does not need to restate the comparative periods in transition and will continue to present financial information and disclosures for periods before January 1, 2019 in accordance with ASC Topic 840. The Company has also chosen to apply the package of practical expedients for existing leases, which provides relief from reassessing: (i) whether a contract is or contains a lease, (ii) lease classification, and (iii) whether initial direct costs (IDCs) can be capitalized. The Company has also made some accounting policy elections to: (i) allow the Company not to separate nonlease components from lease components, and instead to account for those as a single lease component, and (ii) elect not to recognize a ROU asset and a lease liability for leases with a term of 12 months or less (“short-term leases”). Upon adoption of ASC 842 on January 1, 2019, the Company recorded a ROU asset of approximately $3.0 million and a lease liability of approximately $3.8 million. The lease liability was determined based on the present value of the remaining minimum lease payments. The ROU asset was determined based on the value of the lease liability, adjusted for the deferred rent balances of approximately $0.8 million, which were previously included in accrued and other liabilities as well as deferred rent, net of current portion. See Note 8 for further details. The standard did not have a material impact on the condensed consolidated statement of cash flows or the condensed consolidated statement of operations. In February 2018, the FASB issued ASU No. 2018-02, Income Statement – Reporting Comprehensive Income (Topic 220): Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income . In June 2018, the FASB issued ASU No. 2018-07, Compensation - Stock Compensation (Topic 718): Improvements to Nonemployee Share Based Payment Accounting In August 2018, the FASB issued ASU No. 2018-15, Intangibles – Goodwill and Other – Internal – Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract (“ASU 2018-15”). ASU 2018-15 is effective for fiscal years beginning after December 15, 2019 and interim periods therein. Early adoption of ASU 2018-15 is permitted including adoption in any interim period . The Company plans to adopt the standard during 2019. The Company expects the new standard will impact its prospective unaudited condensed consolidated financial statements after adoption related to implementation costs in a cloud computing arrangement if and when entered by the Company. In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820) |
Net Loss Per Share
Net Loss Per Share | 3 Months Ended |
Mar. 31, 2019 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 3. NET LOSS PER SHARE Basic and diluted net loss per share have been computed by dividing the net loss by the weighted-average number of common shares outstanding during the period, without consideration of common share equivalents as their effect would have been antidilutive. The following tables set forth the computation of the Company’s basic and diluted net loss per share (in thousands, except shares and per share data): Three Months Ended March 31, 2019 2018 Numerator: Net loss attributable to CareDx, Inc. used to compute basic and diluted net loss per share $ (7,531 ) $ (8,969 ) Denominator: Weighted-average shares used to compute basic and diluted net loss per share attributable to CareDx, Inc. 41,611,399 29,615,441 Net loss per share attributable to CareDx, Inc.: Basic and diluted $ (0.18 ) $ (0.30 ) The following potentially dilutive securities have been excluded from diluted net loss per share as at March 31, 2019 because their effect would be antidilutive: March 31, 2019 2018 Shares of common stock subject to outstanding options 2,536,412 1,940,010 Shares of common stock subject to outstanding common stock warrants 530,627 3,633,565 Restricted stock units 1,034,484 441,804 Shares of common stock subject to contingent consideration — 227,848 Total common stock equivalents 4,101,523 6,243,227 |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 4. 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. 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 1: Inputs which include quoted prices in active markets for identical assets and liabilities. • Level 2: Inputs other than Level 1 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 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The following table sets forth the Company’s financial assets and liabilities measured at fair value on a recurring basis, as of March 31, 2019 and December 31, 2018 (in thousands): March 31, 2019 Fair Value Measured Using (Level 1) (Level 2) (Level 3) Total Balance Assets Money market funds $ 20,543 $ — $ — $ 20,543 Liabilities Common stock warrant liability $ — $ — $ 10,521 $ 10,521 December 31, 2018 Fair Value Measured Using (Level 1) (Level 2) (Level 3) Total Balance Assets Money market funds $ 59,471 $ — $ — $ 59,471 Liabilities Common stock warrant liability $ — $ — $ 10,003 $ 10,003 The following table presents the issuances, exercises, changes in fair value and reclassifications of the Company’s Level 3 financial instruments that are measured at fair value on a recurring basis (in thousands): (Level 3) Common Balance as of December 31, 2018 $ 10,003 Exercise of warrants (2,491 ) Change in estimated fair value 3,009 Balance as of March 31, 2019 $ 10,521 The Company recognizes transfers between levels of the fair value hierarchy as of the end of the reporting period. There were no transfers between Level 1, Level 2 and Level 3 categories during the periods presented. In determining fair value, the Company uses various valuation approaches within the fair value measurement framework. The valuation methodologies used for the Company’s instruments measured at fair value and their classification in the valuation hierarchy are summarized below: • Money market funds - Investments in money market funds are classified within Level 1. At March 31, 2019 and December 31, 2018, money market funds were included on the balance sheets in cash and cash equivalents. • Common stock warrant liability – The Company utilizes a binomial-lattice pricing model (the “Monte Carlo Simulation Model”) that involves a market condition simulation to estimate the fair value of the warrants. The application of the Monte Carlo Simulation Model requires the use of a number of complex assumptions including the Company’s stock price, expected life of the warrants, stock price volatility determined from the Company’s historical stock prices and stock prices of peer companies in the diagnostics industry, and risk-free rates based on the implied yield currently available in the U.S. Treasury zero-coupon issues with a remaining term equal to the expected life of the warrants. Increases (decreases) in the assumptions discussed above result in a directionally similar impact to the fair value of the common stock warrant liability. Common Stock Warrant Liability Valuation Assumptions March 31, 2019 December 31, 2018 Private Placement Common Stock Warrant Liability Stock Price $ 31.52 $ 25.14 Exercise Price $ 1.12 $ 1.12 Remaining term (in years) 4.04 4.29 Volatility 81.00 % 79.00 % Risk-free interest rate 2.20 % 2.46 % Placement Agent Common Stock Warrant Liability Stock Price $ 31.52 $ 25.14 Exercise Price $ 1.12 $ 1.12 Remaining term (in years) 2.04 2.29 Volatility 85.00 % 86.00 % Risk-free interest rate 2.24 % 2.44 % |
Business Combinations and Asset
Business Combinations and Asset Acquisitions | 3 Months Ended |
Mar. 31, 2019 | |
Business Combinations [Abstract] | |
Business Combinations and Asset Acquisitions | 5. BUSINESS COMBINATIONS AND ASSET ACQUISITIONS Asset Acquisition Illumina License and Commercialization Agreement On May 4, 2018, the Company entered into the License Agreement with Illumina, which provides the Company with certain worldwide distribution, development and commercialization rights to Illumina’s NGS product line for use in the field of bone marrow and solid organ transplantation diagnostic testing (the “Field”). As a result, The License Agreement required the Company to make a $5.0 million initial cash payment to Illumina and further requires the Company to pay royalties in the mid-single to low-double digits on sales of future commercialized products. Pursuant to the License Agreement, the Company is obligated to complete timely development and commercialization of other NGS product lines for use in the Field, and has agreed to minimum purchase commitments of finished products and raw materials from Illumina through 2023. As the License Agreement did not meet the definition of a business combination under ASC Topic 805, Business Combinations, Costs relating to the assets acquired were $5.2 million, comprising of the cash consideration of $5.0 million and associated transaction costs of $0.2 million. A deferred tax balance was not required to be established on the License Agreement date as the book and tax basis of the intangible assets was equivalent to the amount paid. The allocation of the purchase price to identified intangible assets acquired was based on the Company’s best estimate of the fair value of such assets as of the acquisition date. Significant assumptions utilized in the valuation of identified intangible assets were based on company-specific information and projections, which are not observable in the market and are thus considered Level 3 measurements as defined by U.S. GAAP. Customer relationships represent the fair value of future projected revenue that is expected to be derived from sales of TruSight HLA products to existing customers of Illumina. The customer contracts and related relationships value has been estimated utilizing a multi-period excess earnings method under income approach, which reflects the present value of the projected cash flows that are expected to be generated by the customer relationships less charges representing the contribution of other assets to those cash flows that use projected cash flows with and without the intangible asset in place. The economic useful life was determined based on the life of the products, assuming that the existing customers will remain with the Company until the products becomes obsolete. The Company utilized a discount rate of 18% in estimating the fair value of the customer relationships. The acquired in-process technology represents the fair value of products in development that have not reached commercial production at the date of acquisition. The fair value of the products was also determined using the multi-period excess earnings method under income approach. A rate of 30% and 40% for the AlloSeq Tx acquired in-process technology and the AlloSeq BMT acquired in-process technology, respectively, was utilized to discount the cash flows to the present value. The acquired in-process technology will not be amortized until completion of the related products, which is determined to occur when the products commence commercial production. Upon completion, each acquired in-process technology product will be amortized over its estimated useful life. The following table summarizes the fair values of the intangible assets acquired as of the closing date (in thousands): Estimated Fair Value Estimated Useful Lives (Years) Customer relationships: TruSight HLA $ 380 2.6 Acquired in-process technology: AlloSeq Tx 2,719 — Acquired in-process technology: AlloSeq BMT 2,103 — Total $ 5,202 |
Goodwill and Intangible Assets
Goodwill and Intangible Assets | 3 Months Ended |
Mar. 31, 2019 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Goodwill and Intangible Assets | 6. GOODWILL AND INTANGIBLE ASSETS Goodwill Goodwill is recorded when the purchase price of an acquisition exceeds the fair value of the net tangible and identified intangible assets acquired. The Company reported $12.0 million of goodwill on the condensed consolidated balance sheet as of each of March 31, 2019 and December 31, 2018. Goodwill is tested annually for impairment at the reporting unit level during the fourth quarter or earlier upon the occurrence of certain events or substantive changes in circumstances. There were no indicators of impairment in the three months ended March 31, 2019. Intangible Assets The following tables present details of the Company’s intangible assets as of March 31, 2019 (in thousands): March 31, 2019 Gross Carrying Amount Accumulated Amortization Foreign Currency Translation Net Amount Weighted Average Remaining Useful (In Intangible assets with finite lives: Customer relationships: Allenex $ 12,650 $ (2,388 ) $ (1,454 ) $ 8,808 11.8 Customer relationships: Conexio 28 (9 ) (1 ) 18 1.8 Customer relationships: TruSight HLA 380 (123 ) — 257 1.8 Developed technology: Olerup SSP 11,650 (3,330 ) (1,256 ) 7,064 6.8 Acquired technology: QTYPE 4,510 (741 ) (524 ) 3,245 11.8 Acquired technology: Olerup SBT 127 (40 ) (5 ) 82 1.8 Acquired technology: dd-cfDNA 6,650 (762 ) — 5,888 11.6 Trademarks 2,260 (488 ) (197 ) 1,575 11.8 Total intangible assets with finite lives $ 38,255 $ (7,881 ) $ (3,437 ) $ 26,937 Acquired in-process technology: AlloSeq Tx 2,719 — — 2,719 — Acquired in-process technology: AlloSeq BMT 2,103 — — 2,103 — Total intangible assets $ 43,077 $ (7,881 ) $ (3,437 ) $ 31,759 The following tables present details of the Company’s intangible assets as of December 31, 2018 (in thousands): December 31, 2018 Gross Carrying Amount Accumulated Amortization Foreign Currency Translation Net Amount Weighted Average Remaining Useful (In Intangible assets with finite lives: Customer relationships: Allenex $ 12,650 $ (2,198 ) $ (1,129 ) $ 9,323 12.0 Customer relationships: Conexio 28 (6 ) (2 ) 20 2.0 Customer relationships: TruSight HLA 380 (86 ) — 294 2.0 Developed technology: Olerup SSP 11,650 (3,065 ) (998 ) 7,587 7.0 Acquired technology: QTYPE 4,510 (671 ) (407 ) 3,432 12.0 Acquired technology: Olerup SBT 127 (28 ) (6 ) 93 2.0 Acquired technology: dd-cfDNA 6,650 (635 ) — 6,015 11.8 Trademarks 2,260 (454 ) (140 ) 1,666 12.0 Total intangible assets with finite lives $ 38,255 $ (7,143 ) $ (2,682 ) $ 28,430 Acquired in-process technology: AlloSeq Tx 2,719 — — 2,719 — Acquired in-process technology: AlloSeq BMT 2,103 — — 2,103 — Total intangible assets $ 43,077 $ (7,143 ) $ (2,682 ) $ 33,252 Amortization expense was $0.6 million for each of the three months ended March 31, 2019 and 2018, respectively. For the three months ended March 31, 2019, expenses of $0.3 million and $0.3 million were amortized to cost of product and sales and marketing expense, respectively. For the three months ended March 31, 2018, expenses of $0.4 million and $0.2 million were amortized to cost of product and sales and marketing expense, respectively. The following table summarizes the Company’s estimated future amortization expense of intangible assets with finite lives as of March 31, 2019 (in thousands): Years Ending December 31, Cost of Product Sales and Marketing Total Remainder of 2019 $ 1,408 $ 781 $ 2,189 2020 1,878 1,042 2,920 2021 1,831 884 2,715 2022 1,831 884 2,715 2023 1,831 884 2,715 Thereafter 7,499 6,184 13,683 Total future amortization expense $ 16,278 $ 10,659 $ 26,937 The Company evaluates the carrying value of the intangible assets, not subject to amortization, related to acquired in-process technology assets, which are considered to be indefinite‑lived until the completion or abandonment of the associated research and development efforts. Accordingly, amortization of the acquired in-process technology assets will not occur until the products reach commercialization. During the period the assets are considered indefinite‑lived, they are tested for impairment on an annual basis, as well as between annual tests if the Company becomes aware of any events occurring or changes in circumstances that would indicate that the fair values of the acquired in-process technology assets are less than their carrying amounts. An impairment loss would be recorded when the fair value of an acquired in-process technology assets is less than its carrying value. If and when development is complete, which generally occurs when the products are made commercially available, the associated acquired in-process technology asset will be deemed definite‑lived and will then be amortized based on its estimated useful life. |
Balance Sheet Components
Balance Sheet Components | 3 Months Ended |
Mar. 31, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Balance Sheet Components | 7. BALANCE SHEET COMPONENTS Inventory Inventory consisted of the following (in thousands): March 31, 2019 December 2018 Finished goods $ 2,412 $ 2,506 Work in progress 811 651 Raw materials 1,954 1,786 Total inventory $ 5,177 $ 4,943 Accrued and other liabilities Accrued and other liabilities consisted of the following (in thousands): March 31, 2019 December 2018 Short-term lease liability $ 1,866 $ — Clinical studies 1,791 1,815 Professional fees 926 822 Test sample processing fees 780 657 Accrued royalty 395 285 Finance leases – current portion 174 172 Customer overpayments and refunds 173 184 Deferred purchase consideration 143 190 Software implementation costs 75 58 Uninvoiced receipts 65 — Deferred revenue 47 39 Deferred rent – current portion — 432 Other accrued expenses 1,216 983 Total accrued and other liabilities $ 7,651 $ 5,637 |
Commitments
Commitments | 3 Months Ended |
Mar. 31, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments | 8. COMMITMENTS Leases The Company leases its operating and office facilities for various terms under long-term, non-cancelable operating lease agreements in Brisbane, California; West Chester, Pennsylvania; Fremantle, Australia; and Stockholm, Sweden. The lease for the Company’s facility in Vienna, Austria is on a month-to-month basis. The facility leases expire at various dates through 2020. In the normal course of business, it is expected that these leases will be renewed or replaced by leases on other properties. The following table summarizes the lease cost for the three months ended March 31, 2019 (in thousands): March 31, 2019 Operating lease cost $ 435 Finance lease cost 56 Total lease cost $ 491 Other information: Weighted-average remaining lease term - Operating leases (in years) 1.74 Weighted-average remaining lease term - Finance leases (in years) 2.1 Weighted-average discount rate - Operating leases (%) 10.5 % Weighted-average discount rate - Finance leases (%) 6.4 % Rent expense under the non-cancelable operating leases was $0.4 million for each of the three months ended March 31, 2019 and 2018, respectively. Future minimum lease commitments under these operating and finance leases on March 31, 2019, are as follows (in thousands): Years Ending December 31, Finance Leases Operating Leases Remainder of 2019 $ 145 $ 1,665 2020 193 2,160 2021 67 124 2022 — 55 Total future minimum lease payments $ 405 $ 4,004 The current portion of obligations under finance leases is included in accrued and other liabilities on the condensed consolidated balance sheets. The long-term portion is included in other liabilities on the condensed consolidated balance sheets. Royalty Commitments The Board of Trustees of the Leland Stanford Junior University (“Stanford”) In June 2014, the Company entered into a license agreement with Stanford, or the Stanford License, which granted the Company an exclusive license to a patent relating to the diagnosis of rejection in organ transplant recipients using dd-cfDNA. Under the terms of the Stanford License, the Company is required to pay an annual license maintenance fee, six milestone payment amounts and royalties in the low single digits of net sales of products incorporating the licensed technology. The license maintenance fee may be offset against earned royalty payments due on net sales in that year. Company incurred royalties of $0.3 million in the three months ended March 31, 2019. Illumina On May 4, 2018, the Company entered into the License Agreement with Illumina. The License Agreement requires the Company to pay royalties in the mid-single to low-double digits on sales of future commercialized products. In the three months ended March 31, 2019, the Company paid no royalties to Illumina. Other Commitments Pursuant to the License Agreement with Illumina, the Company is obligated to complete timely development and commercialization of other NGS product lines for use in the Field, and has agreed to minimum purchase commitments of finished products and raw materials from Illumina through 2023. Litigation From time to time, the Company may become involved in litigation and other legal actions. The Company estimates the range of liability related to any pending litigation where the amount and range of loss can be estimated. The Company records its best estimate of a loss when the loss is considered probable. Where a liability is probable and there is a range of estimated loss with no best estimate in the range, the Company records a charge equal to at least the minimum estimated liability for a loss contingency when both of the following conditions are met: (i) information available prior to issuance of the financial statements indicates that it is probable that a liability had been incurred at the date of the financial statements and (ii) the range of loss can be reasonably estimated. In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for indemnification for certain liabilities. The exposure under these agreements is unknown because it involves claims that may be made against the Company in the future but have not yet been made. To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations. However, the Company may record charges in the future as a result of these indemnification obligations. The Company also has indemnification obligations to its directors and executive officers for specified events or occurrences, subject to some limits, while they are serving at the Company’s request in such capacities. There have been no claims to date and the Company believes the fair value of these indemnification agreements is minimal. Accordingly, the Company has not recorded any liabilities for these agreements as of March 31, 2019 and as of December 31, 2018. |
Debt
Debt | 3 Months Ended |
Mar. 31, 2019 | |
Transfers And Servicing [Abstract] | |
Debt | 9. DEBT The Company did not have any outstanding debt as of March 31, 2019 or December 31, 2018. JGB Debt In February and March 31, 2018, JGB converted the remaining $26.7 million of principal and accrued interest of the JGB Debt into an aggregate of 6,161,331shares of the Company’s common stock. In connection with these conversions in the three months ended March 31, 2018, the Company recognized $6,000 to common stock and $38.8 million to additional paid in capital; the unamortized debt discount of $2.7 million was extinguished; and the compound derivative liability of $12.1 million was also extinguished. The JGB Debt conversion resulted in a $2.8 million loss on debt extinguishment that was included in debt extinguishment expenses in the condensed consolidated statements of operations for the three months ended March 31, 2018. Danske Bank Term Loan and Credit Facility The Company repaid the full outstanding amount of SEK 47,000,000 (approximately $5.6 million) plus accrued interest of SEK 142,000 (approximately $17,000), under the Danske Term Loan and Credit Facility on April 17, 2018. FastPartner Subordinated Promissory Notes The Company repaid the full amount outstanding of SEK 21,300,000 (approximately $2.5 million), including accrued interest of SEK 1,600,000 (approximately $0.2 million), under the FastPartner Note Agreement on April 17, 2018. Mohammed Al Amoudi Subordinated Promissory Note The Company repaid the full amount outstanding of SEK 15,700,000 (approximately $1.9 million), including accrued interest of SEK 1,200,000 (approximately $0.1 million) under the Al Amoudi Note Agreement on April 17, 2018. Loan Agreement with SSP Primers Aktieboulag The Company repaid the full loan amount outstanding of SEK 10,000,000 (approximately $1.2 million), including accrued interest of SEK 650,000 (approximately $0.1 million) on February 26, 2018. |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2019 | |
Stockholders Equity Note [Abstract] | |
Stockholders' Equity | 10. STOCKHOLDERS’ EQUITY JGB Debt In the three months ended March 31, 2018, JGB converted the remaining $26.7 million of outstanding debt principal and accrued interest for a total issuance of 6,161,331 shares of the Company’s common stock at a price per share of $4.33. Contingent Consideration Liability The Company had a contingent obligation to issue 227,845 shares of the Company’s common stock to the former owners of ImmuMetrix, Inc. (“IMX”), in conjunction with its acquisition of IMX in June 2014. The shares were issuable upon the Company completing 2,500 commercial tests involving the measurement of dd-cfDNA in organ transplant recipients in the United States by June 10, 2020. The Company achieved the contingent consideration milestone of 2,500 commercial tests and issued the 227,848 shares in May 2018. 2018 Public Offering On November 16, 2018, the Company sold in the 2018 Public Offering an aggregate of 2,300,000 shares of its common stock, including 300,000 shares sold pursuant to the underwriters’ full exercise of their option to purchase additional shares at a public offering price of $24.50 per share. Total net proceeds received were $52.9 million net of underwriter’s fees and issuance costs. |
401(K) Plan
401(K) Plan | 3 Months Ended |
Mar. 31, 2019 | |
Compensation And Retirement Disclosure [Abstract] | |
401(K) Plan | 11. 401(K) PLAN The Company sponsors a 401(k) defined contribution plan covering all U.S. employees under the Internal Revenue Code of 1986, as amended. Employee contributions are voluntary and are determined on an individual basis subject to the maximum allowable under federal tax regulations. On January 1, 2018, the Company began to make contributions to the employee plan. The Company incurred expenses related to contributions to the plan of $0.2 million and $0.1 million for the three months ended March 31, 2019 and 2018, respectively. |
Warrants
Warrants | 3 Months Ended |
Mar. 31, 2019 | |
Warrants [Abstract] | |
Warrants | 12. WARRANTS The Company issues common stock warrants in connection with debt or equity financings to a lender, a placement agent or an investor. Issued warrants are considered standalone financial instruments and the terms of each warrant are analyzed for equity or liability classification in accordance with U.S. GAAP. Warrants that are classified as liabilities usually have various features that would require net-cash settlement by the Company. Warrants that are not liabilities, derivatives and/or meet the exception criteria are classified as equity. Warrants liabilities are remeasured at fair value at each period end with changes in fair value recorded in the condensed consolidated statements of operations until expired or exercised. The Company utilizes the Monte Carlo Simulation Model to estimate the fair value of its warrants. Refer to Note 4 for further details. Warrants that are classified as equity are valued at fair value on the date of issuance, recorded in additional paid in capital and not remeasured. In the three months ended March 31, 2019, warrants to purchase approximately 70,000 shares of common stock were exercised for cash proceeds of less than $0.1 million. The warrant liability was remeasured prior to the exercise and a change in fair value of $0.5 million was recorded in the condensed consolidated statement of operations. During the three months ended March 31, 2019 approximately 56,000 warrants were exercised on cashless basis and approximately 25,000 shares were issued. As of March 31, 2019, outstanding warrants to purchase common stock were: Classified as Original Term Exercise Price Number of Shares Underlying Warrants Original issue date: August 2009 Equity 10 years $ 21.78 33,473 July 2010 Equity 9 years $ 21.78 6,694 August 2012 Equity 7 years $ 21.78 111,455 January 2015 Equity 5 years $ 6.96 34,483 April 2016 Liability 7 years $ 1.12 323,021 April 2016 Liability 5 years $ 1.12 21,501 530,627 |
Stock Incentive Plans
Stock Incentive Plans | 3 Months Ended |
Mar. 31, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock Incentive Plans | 13. STOCK INCENTIVE PLANS Stock Options and Restricted Stock Units (“RSU”) The following table summarizes option and unvested RSU activity under the Company’s 2014 Equity Incentive Plan and 2016 Inducement Equity Incentive Plan and related information: Shares Available for Grant Stock Options Outstanding Weighted- Average Exercise Price Number of RSU Shares Weighted- Average Grant Date Fair Value Balance—December 31, 2018 322,178 2,501,057 $ 9.10 968,364 $ 11.49 Additional options authorized 1,655,398 — — — — Common stock awards for services (2,112 ) — — — — RSUs granted (367,800 ) — — 367,800 27.21 RSUs vested — — — (276,954 ) 13.53 Options granted (341,900 ) 341,900 27.52 — — Options exercised — (251,739 ) 5.43 — — Repurchase of common stock under employee incentive plans 83,923 — — — — RSUs forfeited 24,726 — — (24,726 ) 15.24 Options forfeited 54,096 (54,096 ) 11.53 — — Options expired 710 (710 ) 4.37 — — Balance—March 31, 2019 1,429,219 2,536,412 $ 11.89 1,034,484 $ 16.41 The total intrinsic value of options exercised was $6.0 million in the three months ended March 31, 2019. As of March 31, 2019, the total intrinsic value of outstanding RSUs was approximately $32.6 million and there were $13.5 million of unrecognized compensation costs related to RSUs, which are expected to be recognized over a weighted-average period of 2.72 years. Options outstanding that have vested and are expected to vest at March 31, 2019 are as follows: Number of Shares Weighted-Average Exercise Price Weighted-Average Remaining Contractual Life (Years) Aggregate Intrinsic (In Vested 938,223 $ 5.41 6.56 $ 24,497 Expected to vest 1,491,586 15.70 9.17 23,598 Total 2,429,809 $ 48,095 The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying stock options and the fair value of the Company’s common stock at December 31, 2018 for stock options that were in-the-money. The total fair value of options that vested during the three months period ended March 31, 2019 was $0.5 million. As of March 31, 2019, there were approximately $13.1 million of unrecognized compensation costs related to stock options, which are expected to be recognized over a weighted-average period of 3.47 years. 2014 Employee Stock Purchase Plan The Company has an Employee Stock Purchase Plan (the “ESPP”), under which employees can purchase shares of its common stock based on a percentage of their compensation, but not greater than 15% of their earnings; provided, however, an eligible employee’s right to purchase shares of the Company’s common stock may not accrue at a rate which exceeds $25,000 of the fair market value of such shares for each calendar year in which such rights are outstanding. The ESPP has consecutive offering periods of approximately six months in length. The purchase price per share must be equal to the lower of 85% of the fair value of the common stock on the first day of the offering period or on the exercise date. During the offering period in 2018 that ended on December 31, 2018, 31,184 shares were purchased for aggregate proceeds of $0.3 million from the issuance of shares, which occurred on January 2, 2019. During the offering period in 2018 that ended on June 30, 2018, 42,534 shares were purchased for aggregate proceeds of $0.3 million from the issuance of shares, which occurred on July 2, 2018. Valuation Assumptions The estimated fair values of employee stock options and ESPP shares were estimated using the Black-Scholes option-pricing model based on the following weighted-average assumptions: Three Months Ended March 31, 2019 2018 Employee stock options Expected term (in years) 6.0 6.0 Expected volatility 70.33 % 79.96 % Risk-free interest rate 2.57 % 2.51 % Expected dividend yield — % — % Employee stock purchase plan Expected term (in years) 0.5 0.5 Expected volatility 76.66 % 105.32 % Risk-free interest rate 2.51 % 1.61 % Expected dividend yield — % — % Risk-free Interest Rate : Volatility: The Company used an average historical stock price volatility of its own stock and those comparable public companies that were deemed to be representative of future stock price trends. Expected Term: The expected term represents the period for which the Company’s stock-based compensation awards are expected to be outstanding and is based on analyzing the vesting and contractual terms of the awards and the holders’ historical exercise patterns and termination behavior. Expected Dividends: The Company has not paid and does not anticipate paying any dividends in the near future. Stock-based Compensation Expense The following table summarizes stock-based compensation expense relating to employee and nonemployee stock-based awards for the three months ended March 31, 2019 and 2018, included in the condensed consolidated statements of operations as follows (in thousands): Three Months Ended March 31, 2019 2018 Cost of testing services $ 776 $ 61 Research and development 832 213 Sales and marketing 727 64 General and administrative 3,718 368 Total $ 6,053 $ 706 No tax benefit was recognized related to share-based compensation expense since the Company has never reported taxable income and has established a full valuation allowance to offset all of the potential tax benefits associated with its deferred tax assets. In addition, no amounts of stock-based compensation expense were capitalized for the periods presented. |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 14. INCOME TAXES The Company’s effective tax rate may vary from the U.S. federal statutory tax rate due to the change in the mix of earnings in tax jurisdictions with different statutory rates, benefits related to tax credits and the tax impact of non-deductible expenses and other permanent differences between income before income taxes and taxable income. For the three months ended March 31, 2019 and 2018, the Company recorded an income tax benefit of $0.6 million and $0.4 million, respectively. The income tax benefit of $0.6 million, is primarily attributable to the recognition of deferred tax assets from foreign losses and recognition of previous unrecognized tax benefits. The Company assesses the realizability of its net deferred tax assets by evaluating all available evidence, both positive and negative, including (i) cumulative results of operations in recent years, (ii) sources of recent losses, (iii) estimates of future taxable income, and (iv) the length of net operating loss carryforward periods. The Company believes that based on the history of its U.S. losses and other factors, the weight of available evidence indicates that it is more likely than not that it will not be able to realize its U.S. net deferred tax assets. Accordingly, the U.S. net deferred tax assets have been offset by a full valuation allowance. Starting in 2018, companies may be subject to global intangible low tax income (“GILTI”), which is a tax on foreign income in excess of a deemed return on tangible assets of foreign corporations as well as the new base erosion anti-abuse tax (“BEAT”) under the Tax Act. GILTI will be effectively taxed at a tax rate of 10.5%. Due to the complexity of the GILTI tax rules, companies are allowed to make an accounting policy choice of either (1) treating taxes due on future U.S. inclusions in taxable income related to GILTI as a current-period expense when incurred or (2) factoring such amounts into a company’s measurement of its deferred taxes under SAB 118. The Company has not yet made an election with respect to GILTI and does not believe GILTI will have an impact on the Company’s 2019 taxes. The Company will continue to review the GILTI and BEAT rules to determine their applicability to the Company as the rules become effective. |
Segment Reporting
Segment Reporting | 3 Months Ended |
Mar. 31, 2019 | |
Segment Reporting [Abstract] | |
Segment Reporting | 15. SEGMENT REPORTING Operating segments are defined as components of an enterprise for which separate financial information is available that is evaluated regularly by the Company’s Chief Operating Decision Maker (“CODM”), or decision making group, whose function is to allocate resources to and assess the performance of the operating segments. The Company has identified its Chief Executive Officer as the CODM. The Company operates in a single reportable segment. Revenues by geographic regions are based upon the customers’ ship-to address for product revenue and the region of testing for testing services revenue. The following table summarizes reportable revenues by geographic regions (in thousands): Three 2019 2018 Testing services revenue United States $ 21,386 $ 10,460 Rest of the World 132 144 $ 21,518 $ 10,604 Product revenue United States $ 1,832 $ 845 Europe 1,943 1,973 Rest of the World 658 489 $ 4,433 $ 3,307 License and other revenue United States $ 22 $ 142 Europe 9 — $ 31 $ 142 Total United States $ 23,240 $ 11,447 Total Europe $ 1,952 $ 1,973 Total Rest of the World $ 790 $ 633 Total $ 25,982 $ 14,053 The following table summarizes long-lived assets, consisting of property and equipment, net, by geographic regions (in thousands): March 31, 2019 December Long-lived assets: United States $ 2,985 $ 3,235 Europe 548 625 Rest of the World 287 274 Total $ 3,820 $ 4,134 |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2019 | |
Subsequent Events [Abstract] | |
Subsequent Events | 16. SUBSEQUENT EVENTS On May 7, 2019 (the “Closing Date”) the Company completed the acquisition of 100% of the outstanding equity of OTTR Complete Transplant Management (“OTTR”) for a cash consideration of $16 million. OTTR is the leading provider of organ transplant patient tracking software. OTTR provides comprehensive solutions for transplant patient management, which are currently used in over 60 leading transplant centers in the US and Canada. OTTR’s solutions enable integration with electronic medical records (EMR) systems, including Cerner and Epic, providing patient surveillance management tools and outcomes data to transplant centers. The Company plans to account for this transaction as a business combination effective as of the Closing Date. |
Organization and Description _2
Organization and Description of Business (Policies) | 3 Months Ended |
Mar. 31, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Liquidity | Liquidity The Company has incurred significant losses and negative cash flows from operations since its inception and had an accumulated deficit of $319.4 million at March 31, 2019. As of March 31, 2019, the Company had cash and cash equivalents of $57.4 million. The Company may req uire additional financing in the future to fund working capital and pay its obligations as they come due. Additional financing might include issuance of equity securities, debt, cash from collaboration agreements or a combination of these. However, there can be no assurance that the Company will be successful in acquiring additional funding at levels sufficient to fund its operations or on terms favorable to the Company. |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”), and follow the requirements of the Securities and Exchange Commission (the “SEC”) for interim reporting. As permitted under those rules, certain footnotes and other financial information that are normally required by U.S. GAAP can be condensed or omitted. These unaudited condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments that are necessary for a fair statement of the Company’s financial information. The condensed consolidated balance sheet as of December 31, 2018 has been derived from audited consolidated financial statements as of that date but does not include all of the financial information required by U.S. GAAP for complete financial statements. Operating results for the three months ended March 31, 2019 are not necessarily indicative of the results that may be expected for the year ending December 31, 2019. The accompanying unaudited condensed consolidated financial statements include the accounts of the Company and its subsidiaries. Intercompany transactions have been eliminated. |
Reclassifications | Reclassifications Certain prior year amounts have been reclassified to conform with the current year presentation, including separate presentation of debt extinguishment expenses from other expense, net. These reclassifications had no effect on the reported results of operations. |
Use of Estimates | Use of Estimates The preparation of unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities and the reported amounts of revenues and expenses in the unaudited condensed consolidated financial statements and accompanying notes. On an ongoing basis, management evaluates its estimates, including those related to transaction price estimates used for testing services revenue; accrued expenses for clinical studies; inventory valuation; the fair value of issued common stock warrants and embedded derivatives; the fair value of assets and liabilities acquired in a business combination or an assets acquisition (including identifiable intangible assets acquired); the fair value of contingent consideration recorded in connection with a business combination; the grant date fair value assumptions used to estimate stock-based compensation expense; income taxes; impairment of long-lived assets and indefinite-lived assets (including goodwill); and legal contingencies. Actual results could differ from those estimates. |
Concentrations of Credit Risk and Other Risks and Uncertainties | Concentrations of Credit Risk and Other Risks and Uncertainties For the three months ended March 31, 2019 and 2018, approximately 55% and 42%, respectively, of total revenue was derived from Medicare. No other payers or customers represented more than 10% of total revenue for these periods. As of March 31, 2019 and December 31, 2018, approximately 34% and 27%, respectively, of accounts receivable was due from Medicare. No other payer or customer represented more than 10% of accounts receivable on either March 31, 2019 or December 31, 2018. |
Leases | Leases Effective January 1, 2019, the Company adopted ASC Topic 842, Leases The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable; otherwise, the Company uses its incremental borrowing rate. The incremental borrowing rate is determined by using the rate of interest that the Company would pay to borrow on a collateralized basis an amount equal to the lease payments for a similar term and in a similar economic environment. The Company's leases have remaining terms of less than 1 year to 2.33 years, some of which include options to extend the lease term. The Company's lease terms may include renewal options that are reasonably certain to be exercised and termination options that are reasonably certain not to be exercised. Certain finance leases also include bargain purchase options of the leased equipment. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Effective January 1, 2019, the Company adopted ASC 842 using the optional transition method and applied the standard only to leases that existed at that date. Under the optional transition method, the Company does not need to restate the comparative periods in transition and will continue to present financial information and disclosures for periods before January 1, 2019 in accordance with ASC Topic 840. The Company has also chosen to apply the package of practical expedients for existing leases, which provides relief from reassessing: (i) whether a contract is or contains a lease, (ii) lease classification, and (iii) whether initial direct costs (IDCs) can be capitalized. The Company has also made some accounting policy elections to: (i) allow the Company not to separate nonlease components from lease components, and instead to account for those as a single lease component, and (ii) elect not to recognize a ROU asset and a lease liability for leases with a term of 12 months or less (“short-term leases”). Upon adoption of ASC 842 on January 1, 2019, the Company recorded a ROU asset of approximately $3.0 million and a lease liability of approximately $3.8 million. The lease liability was determined based on the present value of the remaining minimum lease payments. The ROU asset was determined based on the value of the lease liability, adjusted for the deferred rent balances of approximately $0.8 million, which were previously included in accrued and other liabilities as well as deferred rent, net of current portion. See Note 8 for further details. The standard did not have a material impact on the condensed consolidated statement of cash flows or the condensed consolidated statement of operations. In February 2018, the FASB issued ASU No. 2018-02, Income Statement – Reporting Comprehensive Income (Topic 220): Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income . In June 2018, the FASB issued ASU No. 2018-07, Compensation - Stock Compensation (Topic 718): Improvements to Nonemployee Share Based Payment Accounting In August 2018, the FASB issued ASU No. 2018-15, Intangibles – Goodwill and Other – Internal – Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract (“ASU 2018-15”). ASU 2018-15 is effective for fiscal years beginning after December 15, 2019 and interim periods therein. Early adoption of ASU 2018-15 is permitted including adoption in any interim period . The Company plans to adopt the standard during 2019. The Company expects the new standard will impact its prospective unaudited condensed consolidated financial statements after adoption related to implementation costs in a cloud computing arrangement if and when entered by the Company. In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820) |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Earnings Per Share [Abstract] | |
Computation of Basic and Diluted Net Loss Per Share | The following tables set forth the computation of the Company’s basic and diluted net loss per share (in thousands, except shares and per share data): Three Months Ended March 31, 2019 2018 Numerator: Net loss attributable to CareDx, Inc. used to compute basic and diluted net loss per share $ (7,531 ) $ (8,969 ) Denominator: Weighted-average shares used to compute basic and diluted net loss per share attributable to CareDx, Inc. 41,611,399 29,615,441 Net loss per share attributable to CareDx, Inc.: Basic and diluted $ (0.18 ) $ (0.30 ) |
Potentially Dilutive Securities Excluded from Diluted Net Loss Per Share | The following potentially dilutive securities have been excluded from diluted net loss per share as at March 31, 2019 because their effect would be antidilutive: March 31, 2019 2018 Shares of common stock subject to outstanding options 2,536,412 1,940,010 Shares of common stock subject to outstanding common stock warrants 530,627 3,633,565 Restricted stock units 1,034,484 441,804 Shares of common stock subject to contingent consideration — 227,848 Total common stock equivalents 4,101,523 6,243,227 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Assets and Liabilities Measured on Recurring Basis | The following table sets forth the Company’s financial assets and liabilities measured at fair value on a recurring basis, as of March 31, 2019 and December 31, 2018 (in thousands): March 31, 2019 Fair Value Measured Using (Level 1) (Level 2) (Level 3) Total Balance Assets Money market funds $ 20,543 $ — $ — $ 20,543 Liabilities Common stock warrant liability $ — $ — $ 10,521 $ 10,521 December 31, 2018 Fair Value Measured Using (Level 1) (Level 2) (Level 3) Total Balance Assets Money market funds $ 59,471 $ — $ — $ 59,471 Liabilities Common stock warrant liability $ — $ — $ 10,003 $ 10,003 |
Summary of Issuances, Exercises, Changes in Fair Value and Reclassifications of Level 3 Financial Instruments | The following table presents the issuances, exercises, changes in fair value and reclassifications of the Company’s Level 3 financial instruments that are measured at fair value on a recurring basis (in thousands): (Level 3) Common Balance as of December 31, 2018 $ 10,003 Exercise of warrants (2,491 ) Change in estimated fair value 3,009 Balance as of March 31, 2019 $ 10,521 |
Summary of Common Stock Warrant Liability Valuation Assumptions | Common Stock Warrant Liability Valuation Assumptions March 31, 2019 December 31, 2018 Private Placement Common Stock Warrant Liability Stock Price $ 31.52 $ 25.14 Exercise Price $ 1.12 $ 1.12 Remaining term (in years) 4.04 4.29 Volatility 81.00 % 79.00 % Risk-free interest rate 2.20 % 2.46 % Placement Agent Common Stock Warrant Liability Stock Price $ 31.52 $ 25.14 Exercise Price $ 1.12 $ 1.12 Remaining term (in years) 2.04 2.29 Volatility 85.00 % 86.00 % Risk-free interest rate 2.24 % 2.44 % |
Business Combinations and Ass_2
Business Combinations and Asset Acquisitions (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Illumina [Member] | |
Summary of Fair Values of Assets Acquired and Liabilities Assumed as of Acquisition Date | The following table summarizes the fair values of the intangible assets acquired as of the closing date (in thousands): Estimated Fair Value Estimated Useful Lives (Years) Customer relationships: TruSight HLA $ 380 2.6 Acquired in-process technology: AlloSeq Tx 2,719 — Acquired in-process technology: AlloSeq BMT 2,103 — Total $ 5,202 |
Goodwill and Intangible Assets
Goodwill and Intangible Assets (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Summary of Intangible Assets | The following tables present details of the Company’s intangible assets as of March 31, 2019 (in thousands): March 31, 2019 Gross Carrying Amount Accumulated Amortization Foreign Currency Translation Net Amount Weighted Average Remaining Useful (In Intangible assets with finite lives: Customer relationships: Allenex $ 12,650 $ (2,388 ) $ (1,454 ) $ 8,808 11.8 Customer relationships: Conexio 28 (9 ) (1 ) 18 1.8 Customer relationships: TruSight HLA 380 (123 ) — 257 1.8 Developed technology: Olerup SSP 11,650 (3,330 ) (1,256 ) 7,064 6.8 Acquired technology: QTYPE 4,510 (741 ) (524 ) 3,245 11.8 Acquired technology: Olerup SBT 127 (40 ) (5 ) 82 1.8 Acquired technology: dd-cfDNA 6,650 (762 ) — 5,888 11.6 Trademarks 2,260 (488 ) (197 ) 1,575 11.8 Total intangible assets with finite lives $ 38,255 $ (7,881 ) $ (3,437 ) $ 26,937 Acquired in-process technology: AlloSeq Tx 2,719 — — 2,719 — Acquired in-process technology: AlloSeq BMT 2,103 — — 2,103 — Total intangible assets $ 43,077 $ (7,881 ) $ (3,437 ) $ 31,759 The following tables present details of the Company’s intangible assets as of December 31, 2018 (in thousands): December 31, 2018 Gross Carrying Amount Accumulated Amortization Foreign Currency Translation Net Amount Weighted Average Remaining Useful (In Intangible assets with finite lives: Customer relationships: Allenex $ 12,650 $ (2,198 ) $ (1,129 ) $ 9,323 12.0 Customer relationships: Conexio 28 (6 ) (2 ) 20 2.0 Customer relationships: TruSight HLA 380 (86 ) — 294 2.0 Developed technology: Olerup SSP 11,650 (3,065 ) (998 ) 7,587 7.0 Acquired technology: QTYPE 4,510 (671 ) (407 ) 3,432 12.0 Acquired technology: Olerup SBT 127 (28 ) (6 ) 93 2.0 Acquired technology: dd-cfDNA 6,650 (635 ) — 6,015 11.8 Trademarks 2,260 (454 ) (140 ) 1,666 12.0 Total intangible assets with finite lives $ 38,255 $ (7,143 ) $ (2,682 ) $ 28,430 Acquired in-process technology: AlloSeq Tx 2,719 — — 2,719 — Acquired in-process technology: AlloSeq BMT 2,103 — — 2,103 — Total intangible assets $ 43,077 $ (7,143 ) $ (2,682 ) $ 33,252 |
Summary of Estimated Future Amortization Expense of Intangible Assets | The following table summarizes the Company’s estimated future amortization expense of intangible assets with finite lives as of March 31, 2019 (in thousands): Years Ending December 31, Cost of Product Sales and Marketing Total Remainder of 2019 $ 1,408 $ 781 $ 2,189 2020 1,878 1,042 2,920 2021 1,831 884 2,715 2022 1,831 884 2,715 2023 1,831 884 2,715 Thereafter 7,499 6,184 13,683 Total future amortization expense $ 16,278 $ 10,659 $ 26,937 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Summary of Inventory | Inventory consisted of the following (in thousands): March 31, 2019 December 2018 Finished goods $ 2,412 $ 2,506 Work in progress 811 651 Raw materials 1,954 1,786 Total inventory $ 5,177 $ 4,943 |
Components of Accrued and Other Liabilities | Accrued and other liabilities Accrued and other liabilities consisted of the following (in thousands): March 31, 2019 December 2018 Short-term lease liability $ 1,866 $ — Clinical studies 1,791 1,815 Professional fees 926 822 Test sample processing fees 780 657 Accrued royalty 395 285 Finance leases – current portion 174 172 Customer overpayments and refunds 173 184 Deferred purchase consideration 143 190 Software implementation costs 75 58 Uninvoiced receipts 65 — Deferred revenue 47 39 Deferred rent – current portion — 432 Other accrued expenses 1,216 983 Total accrued and other liabilities $ 7,651 $ 5,637 |
Commitments (Tables)
Commitments (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Summary of Lease Cost | The following table summarizes the lease cost for the three months ended March 31, 2019 (in thousands): March 31, 2019 Operating lease cost $ 435 Finance lease cost 56 Total lease cost $ 491 Other information: Weighted-average remaining lease term - Operating leases (in years) 1.74 Weighted-average remaining lease term - Finance leases (in years) 2.1 Weighted-average discount rate - Operating leases (%) 10.5 % Weighted-average discount rate - Finance leases (%) 6.4 % |
Future Minimum Lease Commitments under Operating and Finance Leases | Future minimum lease commitments under these operating and finance leases on March 31, 2019, are as follows (in thousands): Years Ending December 31, Finance Leases Operating Leases Remainder of 2019 $ 145 $ 1,665 2020 193 2,160 2021 67 124 2022 — 55 Total future minimum lease payments $ 405 $ 4,004 |
Warrants (Tables)
Warrants (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Common Stock [Member] | |
Class Of Warrant Or Right [Line Items] | |
Components of Warrants Outstanding | As of March 31, 2019, outstanding warrants to purchase common stock were: Classified as Original Term Exercise Price Number of Shares Underlying Warrants Original issue date: August 2009 Equity 10 years $ 21.78 33,473 July 2010 Equity 9 years $ 21.78 6,694 August 2012 Equity 7 years $ 21.78 111,455 January 2015 Equity 5 years $ 6.96 34,483 April 2016 Liability 7 years $ 1.12 323,021 April 2016 Liability 5 years $ 1.12 21,501 530,627 |
Stock Incentive Plans (Tables)
Stock Incentive Plans (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Summary of Option, Unvested RSU Activity under 2014 Equity Incentive Plan and 2016 Inducement Equity Incentive Plan and Related Information | The following table summarizes option and unvested RSU activity under the Company’s 2014 Equity Incentive Plan and 2016 Inducement Equity Incentive Plan and related information: Shares Available for Grant Stock Options Outstanding Weighted- Average Exercise Price Number of RSU Shares Weighted- Average Grant Date Fair Value Balance—December 31, 2018 322,178 2,501,057 $ 9.10 968,364 $ 11.49 Additional options authorized 1,655,398 — — — — Common stock awards for services (2,112 ) — — — — RSUs granted (367,800 ) — — 367,800 27.21 RSUs vested — — — (276,954 ) 13.53 Options granted (341,900 ) 341,900 27.52 — — Options exercised — (251,739 ) 5.43 — — Repurchase of common stock under employee incentive plans 83,923 — — — — RSUs forfeited 24,726 — — (24,726 ) 15.24 Options forfeited 54,096 (54,096 ) 11.53 — — Options expired 710 (710 ) 4.37 — — Balance—March 31, 2019 1,429,219 2,536,412 $ 11.89 1,034,484 $ 16.41 |
Summary of Options Outstanding and Exercisable Vested or Expected to Vest | Options outstanding that have vested and are expected to vest at March 31, 2019 are as follows: Number of Shares Weighted-Average Exercise Price Weighted-Average Remaining Contractual Life (Years) Aggregate Intrinsic (In Vested 938,223 $ 5.41 6.56 $ 24,497 Expected to vest 1,491,586 15.70 9.17 23,598 Total 2,429,809 $ 48,095 |
Weighted-Average Assumptions Used to Estimate Fair Values of Share-Based Awards | The estimated fair values of employee stock options and ESPP shares were estimated using the Black-Scholes option-pricing model based on the following weighted-average assumptions: Three Months Ended March 31, 2019 2018 Employee stock options Expected term (in years) 6.0 6.0 Expected volatility 70.33 % 79.96 % Risk-free interest rate 2.57 % 2.51 % Expected dividend yield — % — % Employee stock purchase plan Expected term (in years) 0.5 0.5 Expected volatility 76.66 % 105.32 % Risk-free interest rate 2.51 % 1.61 % Expected dividend yield — % — % |
Summary of Expense Relating to Employee and Nonemployee Stock-Based Payment Awards from Stock Options and RSUs | The following table summarizes stock-based compensation expense relating to employee and nonemployee stock-based awards for the three months ended March 31, 2019 and 2018, included in the condensed consolidated statements of operations as follows (in thousands): Three Months Ended March 31, 2019 2018 Cost of testing services $ 776 $ 61 Research and development 832 213 Sales and marketing 727 64 General and administrative 3,718 368 Total $ 6,053 $ 706 |
Segment Reporting (Tables)
Segment Reporting (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Segment Reporting [Abstract] | |
Reportable Revenues by Geographic Regions | Revenues by geographic regions are based upon the customers’ ship-to address for product revenue and the region of testing for testing services revenue. The following table summarizes reportable revenues by geographic regions (in thousands): Three 2019 2018 Testing services revenue United States $ 21,386 $ 10,460 Rest of the World 132 144 $ 21,518 $ 10,604 Product revenue United States $ 1,832 $ 845 Europe 1,943 1,973 Rest of the World 658 489 $ 4,433 $ 3,307 License and other revenue United States $ 22 $ 142 Europe 9 — $ 31 $ 142 Total United States $ 23,240 $ 11,447 Total Europe $ 1,952 $ 1,973 Total Rest of the World $ 790 $ 633 Total $ 25,982 $ 14,053 |
Long-Lived Assets Consisting of Property and Equipment, Net by Geographic Regions | The following table summarizes long-lived assets, consisting of property and equipment, net, by geographic regions (in thousands): March 31, 2019 December Long-lived assets: United States $ 2,985 $ 3,235 Europe 548 625 Rest of the World 287 274 Total $ 3,820 $ 4,134 |
Organization and Description _3
Organization and Description of Business - Additional Information (Detail) - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2019 | Dec. 31, 2018 | |
Schedule of Capitalization, Equity [Line Items] | ||
Accumulated deficit | $ 319,376,000 | $ 311,845,000 |
Cash and cash equivalents | 57,432,000 | 64,616,000 |
Medicare [Member] | AlloMap Testing Service [Member] | ||
Schedule of Capitalization, Equity [Line Items] | ||
Reimbursement rate | 3,240 | $ 3,240 |
Medicare [Member] | AlloSure Testing Service [Member] | ||
Schedule of Capitalization, Equity [Line Items] | ||
Reimbursement rate | $ 2,841 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies - Additional Information - Concentration of Credit Risk (Detail) | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | |
Services Revenue [Member] | Customer Concentration Risk [Member] | Minimum [Member] | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 10.00% | 10.00% | |
Services Revenue [Member] | Customer Concentration Risk [Member] | Medicare [Member] | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 55.00% | 42.00% | |
Accounts Receivable [Member] | Credit Concentration Risk [Member] | Minimum [Member] | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 10.00% | 10.00% | |
Accounts Receivable [Member] | Credit Concentration Risk [Member] | Medicare [Member] | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 34.00% | 27.00% |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2019 | Jan. 01, 2019 | Dec. 31, 2018 | |
Summary Of Significant Accounting Policies [Line Items] | |||
Remaining operating and finance lease term lower limit | less than 1 year | ||
Operating lease, right-of-use asset | $ 2,506 | $ 0 | |
ASU 2016-02 [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Operating lease, right-of-use asset | $ 3,000 | ||
Operating lease, liability | 3,800 | ||
Deferred rent | $ 800 | ||
Maximum [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Remaining lease term | 2 years 3 months 29 days |
Net Loss Per Share - Computatio
Net Loss Per Share - Computation of Basic and Diluted Net Loss Per Share (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Numerator: | ||
Net loss attributable to CareDx, Inc. used to compute basic and diluted net loss per share | $ (7,531) | $ (8,969) |
Denominator: | ||
Weighted-average shares used to compute basic and diluted net loss per share attributable to CareDx, Inc. | 41,611,399 | 29,615,441 |
Net loss per share attributable to CareDx, Inc.: | ||
Basic and diluted | $ (0.18) | $ (0.30) |
Net Loss Per Share - Potentiall
Net Loss Per Share - Potentially Dilutive Securities Excluded from Diluted Net Loss Per Share (Detail) - shares | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potential dilutive securities excluded from diluted net loss per share attributable to common stockholders, Total | 4,101,523 | 6,243,227 |
Shares of common stock subject to outstanding options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potential dilutive securities excluded from diluted net loss per share attributable to common stockholders, Total | 2,536,412 | 1,940,010 |
Shares of common stock subject to outstanding common stock warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potential dilutive securities excluded from diluted net loss per share attributable to common stockholders, Total | 530,627 | 3,633,565 |
Shares of common stock subject to contingent consideration [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potential dilutive securities excluded from diluted net loss per share attributable to common stockholders, Total | 227,848 | |
Restricted Stock Units (RSUs) [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potential dilutive securities excluded from diluted net loss per share attributable to common stockholders, Total | 1,034,484 | 441,804 |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Value of Financial Assets and Liabilities Measured on Recurring Basis (Detail) - Recurring [Member] - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Assets | ||
Money market funds | $ 20,543 | $ 59,471 |
Liabilities | ||
Common stock warrant liability | 10,521 | 10,003 |
Fair Value Measured Using - (Level 1) [Member] | ||
Assets | ||
Money market funds | 20,543 | 59,471 |
Liabilities | ||
Common stock warrant liability | 0 | 0 |
Fair Value Measured Using - (Level 2) [Member] | ||
Assets | ||
Money market funds | 0 | 0 |
Liabilities | ||
Common stock warrant liability | 0 | 0 |
Fair Value Measured Using - (Level 3) [Member] | ||
Assets | ||
Money market funds | 0 | 0 |
Liabilities | ||
Common stock warrant liability | $ 10,521 | $ 10,003 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Issuances, Exercises, Changes in Fair Value and Reclassifications of Level 3 Financial Instruments (Detail) - Fair Value Measured Using - (Level 3) [Member] - Common Stock Warrant Liability [Member] $ in Thousands | 3 Months Ended |
Mar. 31, 2019USD ($) | |
Significant Unobservable Inputs (Level 3) [Line Items] | |
Beginning Balance | $ 10,003 |
Exercise of warrants | (2,491) |
Change in estimated fair value | 3,009 |
Ending Balance | $ 10,521 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2019 | Dec. 31, 2018 | |
Fair Value Disclosures [Abstract] | ||
Transfers between Level 1, Level 2 and Level 3 categories during the periods | $ 0 | $ 0 |
Fair Value Measurements - Sum_2
Fair Value Measurements - Summary of Common Stock Warrant Liability Valuation Assumptions (Detail) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2019$ / shares | Dec. 31, 2018$ / shares | |
Private Placement Common Stock Warrant Liability [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Stock Price | $ 31.52 | $ 25.14 |
Private Placement Common Stock Warrant Liability [Member] | Exercise Price [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Exercise Price | $ 1.12 | $ 1.12 |
Private Placement Common Stock Warrant Liability [Member] | Remaining Term (in Years) [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Remaining term (in years) | 4 years 14 days | 4 years 3 months 14 days |
Private Placement Common Stock Warrant Liability [Member] | Volatility [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Derivative liability, measurement input | 81 | 79 |
Private Placement Common Stock Warrant Liability [Member] | Risk-Free Interest Rate [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Derivative liability, measurement input | 2.20 | 2.46 |
Placement Agent Common Stock Warrant Liability [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Stock Price | $ 31.52 | $ 25.14 |
Placement Agent Common Stock Warrant Liability [Member] | Exercise Price [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Exercise Price | $ 1.12 | $ 1.12 |
Placement Agent Common Stock Warrant Liability [Member] | Remaining Term (in Years) [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Remaining term (in years) | 2 years 14 days | 2 years 3 months 14 days |
Placement Agent Common Stock Warrant Liability [Member] | Volatility [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Derivative liability, measurement input | 85 | 86 |
Placement Agent Common Stock Warrant Liability [Member] | Risk-Free Interest Rate [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Derivative liability, measurement input | 2.24 | 2.44 |
Business Combinations and Ass_3
Business Combinations and Asset Acquisitions - Additional Information (Detail) $ in Millions | May 04, 2018USD ($) |
Discount Rate [Member] | Customer Relationships [Member] | |
Business Acquisition [Line Items] | |
Rate used in estimating fair value | 18 |
Illumina [Member] | |
Business Acquisition [Line Items] | |
Initial cash payment under license agreement | $ 5 |
Illumina [Member] | Discount Rate [Member] | Acquired in-process technology AlloSeq [Member] | Tx [Member] | |
Business Acquisition [Line Items] | |
Rate used in estimating fair value | 30 |
Illumina [Member] | Discount Rate [Member] | Acquired in-process technology AlloSeq [Member] | BMT [Member] | |
Business Acquisition [Line Items] | |
Rate used in estimating fair value | 40 |
Illumina [Member] | Conexio [Member] | |
Business Acquisition [Line Items] | |
Consideration paid for asset acquisition | $ 5.2 |
Asset acquisition cash consideration transferred | 5 |
Transaction costs related to asset acquisition | $ 0.2 |
Business Combinations and Ass_4
Business Combinations and Asset Acquisitions - Summary of Fair Values of Assets Acquired and Liabilities Assumed as of Acquisition Date (Detail) - USD ($) $ in Thousands | May 04, 2018 | Mar. 31, 2019 | Dec. 31, 2018 |
Customer Relationships [Member] | TruSight [Member] | |||
Business Acquisition [Line Items] | |||
Estimated useful life of identified intangible asset | 1 year 9 months 18 days | 2 years | |
Customer Relationships [Member] | TruSight [Member] | HLA [Member] | |||
Business Acquisition [Line Items] | |||
Estimated fair value of identified intangible assets | $ 380 | ||
Estimated useful life of identified intangible asset | 2 years 7 months 6 days | ||
Illumina [Member] | |||
Business Acquisition [Line Items] | |||
Estimated fair value of identified intangible assets | $ 5,202 | ||
Illumina [Member] | Acquired in-process technology AlloSeq [Member] | Tx [Member] | |||
Business Acquisition [Line Items] | |||
Estimated fair value of identified intangible assets | 2,719 | ||
Illumina [Member] | Acquired in-process technology AlloSeq [Member] | BMT [Member] | |||
Business Acquisition [Line Items] | |||
Estimated fair value of identified intangible assets | $ 2,103 |
Goodwill and Intangible Asset_2
Goodwill and Intangible Assets - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | |
Goodwill And Intangible Assets [Line Items] | |||
Goodwill | $ 12,005 | $ 12,005 | |
Amortization expense of intangible assets | 600 | $ 600 | |
Cost of Product [Member] | |||
Goodwill And Intangible Assets [Line Items] | |||
Amortization expense of intangible assets | 300 | 400 | |
Sales and Marketing Expense [Member] | |||
Goodwill And Intangible Assets [Line Items] | |||
Amortization expense of intangible assets | $ 300 | $ 200 |
Goodwill and Intangible Asset_3
Goodwill and Intangible Assets - Summary of Intangible Assets (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2019 | Dec. 31, 2018 | |
Intangible assets with finite lives: | ||
Gross Carrying Amount | $ 38,255 | $ 38,255 |
Accumulated Amortization | (7,881) | (7,143) |
Foreign Currency Translation | (3,437) | (2,682) |
Net Carrying Amount | 26,937 | 28,430 |
Intangible Assets, Net (Excluding Goodwill) | ||
Total intangible assets, Gross Carrying Amount | 43,077 | 43,077 |
Total intangible assets, Accumulated Amortization | (7,881) | (7,143) |
Total intangible assets, Foreign Currency Translation | (3,437) | (2,682) |
Total intangible assets, net | 31,759 | 33,252 |
Customer Relationships [Member] | Allenex [Member] | ||
Intangible assets with finite lives: | ||
Gross Carrying Amount | 12,650 | 12,650 |
Accumulated Amortization | (2,388) | (2,198) |
Foreign Currency Translation | (1,454) | (1,129) |
Net Carrying Amount | $ 8,808 | $ 9,323 |
Estimated useful life of identified intangible asset | 11 years 9 months 18 days | 12 years |
Customer Relationships [Member] | Conexio [Member] | ||
Intangible assets with finite lives: | ||
Gross Carrying Amount | $ 28 | $ 28 |
Accumulated Amortization | (9) | (6) |
Foreign Currency Translation | (1) | (2) |
Net Carrying Amount | $ 18 | $ 20 |
Estimated useful life of identified intangible asset | 1 year 9 months 18 days | 2 years |
Customer Relationships [Member] | TruSight [Member] | ||
Intangible assets with finite lives: | ||
Gross Carrying Amount | $ 380 | $ 380 |
Accumulated Amortization | (123) | (86) |
Foreign Currency Translation | 0 | 0 |
Net Carrying Amount | $ 257 | $ 294 |
Estimated useful life of identified intangible asset | 1 year 9 months 18 days | 2 years |
Developed Technology [Member] | ||
Intangible assets with finite lives: | ||
Gross Carrying Amount | $ 11,650 | $ 11,650 |
Accumulated Amortization | (3,330) | (3,065) |
Foreign Currency Translation | (1,256) | (998) |
Net Carrying Amount | $ 7,064 | $ 7,587 |
Estimated useful life of identified intangible asset | 6 years 9 months 18 days | 7 years |
Acquired Technology - QTYPE [Member] | ||
Intangible assets with finite lives: | ||
Gross Carrying Amount | $ 4,510 | $ 4,510 |
Accumulated Amortization | (741) | (671) |
Foreign Currency Translation | (524) | (407) |
Net Carrying Amount | $ 3,245 | $ 3,432 |
Estimated useful life of identified intangible asset | 11 years 9 months 18 days | 12 years |
Acquired Technology SBT [Member] | Olerup [Member] | ||
Intangible assets with finite lives: | ||
Gross Carrying Amount | $ 127 | $ 127 |
Accumulated Amortization | (40) | (28) |
Foreign Currency Translation | (5) | (6) |
Net Carrying Amount | $ 82 | $ 93 |
Estimated useful life of identified intangible asset | 1 year 9 months 18 days | 2 years |
Acquired Technology dd-cfDNA [Member] | ||
Intangible assets with finite lives: | ||
Gross Carrying Amount | $ 6,650 | $ 6,650 |
Accumulated Amortization | (762) | (635) |
Foreign Currency Translation | 0 | 0 |
Net Carrying Amount | $ 5,888 | $ 6,015 |
Estimated useful life of identified intangible asset | 11 years 7 months 6 days | 11 years 9 months 18 days |
Trademarks [Member] | ||
Intangible assets with finite lives: | ||
Gross Carrying Amount | $ 2,260 | $ 2,260 |
Accumulated Amortization | (488) | (454) |
Foreign Currency Translation | (197) | (140) |
Net Carrying Amount | $ 1,575 | $ 1,666 |
Estimated useful life of identified intangible asset | 11 years 9 months 18 days | 12 years |
Acquired in-process technology AlloSeq [Member] | Tx [Member] | ||
Intangible assets with indefinite lives: | ||
Net Carrying Amount | $ 2,719 | $ 2,719 |
Acquired in-process technology AlloSeq [Member] | BMT [Member] | ||
Intangible assets with indefinite lives: | ||
Foreign Currency Translation | 0 | 0 |
Net Carrying Amount | $ 2,103 | $ 2,103 |
Goodwill and Intangible Asset_4
Goodwill and Intangible Assets - Summary of Estimated Future Amortization Expense of Intangible Assets with Finite Lives (Detail) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Finite-Lived Intangible Assets, Net, Amortization Expense, Fiscal Year Maturity [Abstract] | ||
Remainder of 2019 | $ 2,189 | |
2020 | 2,920 | |
2021 | 2,715 | |
2022 | 2,715 | |
2023 | 2,715 | |
Thereafter | 13,683 | |
Net Carrying Amount | 26,937 | $ 28,430 |
Cost of Product [Member] | ||
Finite-Lived Intangible Assets, Net, Amortization Expense, Fiscal Year Maturity [Abstract] | ||
Remainder of 2019 | 1,408 | |
2020 | 1,878 | |
2021 | 1,831 | |
2022 | 1,831 | |
2023 | 1,831 | |
Thereafter | 7,499 | |
Net Carrying Amount | 16,278 | |
Sales and marketing [Member] | ||
Finite-Lived Intangible Assets, Net, Amortization Expense, Fiscal Year Maturity [Abstract] | ||
Remainder of 2019 | 781 | |
2020 | 1,042 | |
2021 | 884 | |
2022 | 884 | |
2023 | 884 | |
Thereafter | 6,184 | |
Net Carrying Amount | $ 10,659 |
Balance Sheet Components - Summ
Balance Sheet Components - Summary of Inventory (Detail) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Inventory Disclosure [Abstract] | ||
Finished goods | $ 2,412 | $ 2,506 |
Work in progress | 811 | 651 |
Raw materials | 1,954 | 1,786 |
Total inventory | $ 5,177 | $ 4,943 |
Balance Sheet Components - Comp
Balance Sheet Components - Components of Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Payables And Accruals [Abstract] | ||
Short-term lease liability | $ 1,866 | |
Clinical studies | 1,791 | $ 1,815 |
Professional fees | 926 | 822 |
Test sample processing fees | 780 | 657 |
Accrued royalty | 395 | 285 |
Finance leases – current portion | 174 | 172 |
Customer overpayments and refunds | 173 | 184 |
Deferred purchase consideration | 143 | 190 |
Software implementation costs | 75 | 58 |
Uninvoiced receipts | 65 | 0 |
Deferred revenue | 47 | 39 |
Deferred rent – current portion | 432 | |
Other accrued expenses | 1,216 | 983 |
Total accrued and other liabilities | $ 7,651 | $ 5,637 |
Commitments - Additional Inform
Commitments - Additional Information (Detail) - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Loss Contingencies [Line Items] | ||
Facility leases expiration period | 2020 | |
Rent expense under non-cancelable operating leases | $ 400,000 | $ 400,000 |
Royalties incurred | 300,000 | |
Illumina [Member] | ||
Loss Contingencies [Line Items] | ||
Royalties incurred | $ 0 |
Commitments - Summary of Lease
Commitments - Summary of Lease Cost (Detail) $ in Thousands | 3 Months Ended |
Mar. 31, 2019USD ($) | |
Commitments And Contingencies Disclosure [Abstract] | |
Operating lease cost | $ 435 |
Finance lease cost | 56 |
Total lease cost | $ 491 |
Commitments - Summary of Other
Commitments - Summary of Other Information Related to Lease (Detail) | Mar. 31, 2019 |
Other information: | |
Weighted-average remaining lease term - Operating leases (in years) | 1 year 8 months 26 days |
Weighted-average remaining lease term - Finance leases (in years) | 2 years 1 month 6 days |
Weighted-average discount rate - Operating leases (%) | 10.50% |
Weighted-average discount rate - Finance leases (%) | 6.40% |
Commitments - Future Minimum Le
Commitments - Future Minimum Lease Commitments under Operating and Finance Leases (Detail) $ in Thousands | Mar. 31, 2019USD ($) |
Finance Leases | |
Remainder of 2019 | $ 145 |
2020 | 193 |
2021 | 67 |
2022 | 0 |
Total future minimum lease payments | 405 |
Operating Leases | |
Remainder of 2019 | 1,665 |
2020 | 2,160 |
2021 | 124 |
2022 | 55 |
Total future minimum lease payments | $ 4,004 |
Debt - Additional Information (
Debt - Additional Information (Detail) | Apr. 17, 2018USD ($) | Apr. 17, 2018SEK (kr) | Feb. 26, 2018USD ($) | Feb. 26, 2018SEK (kr) | Mar. 31, 2018USD ($)shares | Mar. 31, 2018USD ($) | Mar. 31, 2019USD ($) | Dec. 30, 2018USD ($) |
Debt Instrument [Line Items] | ||||||||
Current portion of long-term debt | $ 0 | $ 0 | ||||||
Long-term debt, net of current portion | $ 0 | $ 0 | ||||||
Amount recognized to additional paid in capital | $ 38,854,000 | |||||||
Loss on debt extinguishment | 2,806,000 | |||||||
Danske Term Loan and Credit Facility [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Repayment of accrued interest | $ 17,000 | kr 142,000 | ||||||
Danske Bank A S [Member] | Danske Term Loan and Credit Facility [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Repayment of outstanding debt | 5,600,000 | 47,000,000 | ||||||
S S P Primers Aktieboulag | Allenex [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Repayment of outstanding debt | $ 1,200,000 | kr 10,000,000 | ||||||
Repayment of accrued interest | $ 100,000 | kr 650,000 | ||||||
Common Stock [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Amount recognized to additional paid in capital | 6,000 | |||||||
JGB Debt [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Debentures convertible into common stock, outstanding principal amount | $ 26,700,000 | |||||||
Debentures convertible into common stock | shares | 6,161,331 | |||||||
Amount recognized to additional paid in capital | 38,800,000 | |||||||
Extinguishment of unamortized debt discount | 2,700,000 | |||||||
Extinguishment of compound derivative liability | 12,100,000 | |||||||
JGB Debt [Member] | Other Income (Expense) [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Loss on debt extinguishment | 2,800,000 | |||||||
JGB Debt [Member] | Common Stock [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Debentures convertible into common stock, outstanding principal amount | $ 6,000 | |||||||
Subordinated Promissory Note [Member] | FastPartner AB [Member] | Allenex [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Repayment of outstanding debt | 2,500,000 | 21,300,000 | ||||||
Repayment of accrued interest | 200,000 | 1,600,000 | ||||||
Subordinated Promissory Note [Member] | Mohammed Al Amoudi [Member] | Allenex [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Repayment of outstanding debt | 1,900,000 | 15,700,000 | ||||||
Repayment of accrued interest | $ 100,000 | kr 1,200,000 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) $ / shares in Units, $ in Millions | Nov. 16, 2018USD ($)$ / sharesshares | May 22, 2018CommercialTestshares | Jun. 30, 2014shares | Mar. 31, 2019CommercialTest | Mar. 31, 2018USD ($)$ / sharesshares |
ImmuMetrix, Inc. [Member] | |||||
Class Of Stock [Line Items] | |||||
Issuable common stock under contingent obligation | 227,845 | ||||
Number of shares issued pursuant to contingent consideration | 227,848 | ||||
Milestone description | The shares were issuable upon the Company completing 2,500 commercial tests involving the measurement of dd-cfDNA in organ transplant recipients in the United States by June 10, 2020. | ||||
Commercial test, measurement and completion date | Jun. 10, 2020 | ||||
Number of commercial tests involving the measurement of cfDNA to be completed | CommercialTest | 2,500 | ||||
Number of achieved contingent consideration milestone of commercial tests involving the measurement of cfDNA | CommercialTest | 2,500 | ||||
Common Stock [Member] | 2018 Public Offering [Member] | |||||
Class Of Stock [Line Items] | |||||
Common stock shares issued | 2,300,000 | ||||
Common stock offer price per share | $ / shares | $ 24.50 | ||||
Option to purchase additional shares | 300,000 | ||||
Net proceeds from common stock shares issued at public offering | $ | $ 52.9 | ||||
Common Stock [Member] | JGB Debt [Member] | |||||
Class Of Stock [Line Items] | |||||
Conversion of debentures into shares of common stock | $ | $ 26.7 | ||||
Common stock shares issued | 6,161,331 | ||||
Common stock offer price per share | $ / shares | $ 4.33 |
401(K) Plan - Additional Inform
401(K) Plan - Additional Information (Detail) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Compensation And Retirement Disclosure [Abstract] | ||
Expense incurred related to plan | $ 0.2 | $ 0.1 |
Warrants - Additional Informati
Warrants - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Class Of Warrant Or Right [Line Items] | ||
Purchase of common stock warrants exercised | 70,000 | |
Proceeds from exercise of warrants | $ 78 | $ 25 |
Estimated fair value of warrant liability remeasurement income (expense) | $ 500 | |
Exercise of warrants | 56,000 | |
Shares issued | 25,000 | |
Maximum [Member] | ||
Class Of Warrant Or Right [Line Items] | ||
Proceeds from exercise of warrants | $ 100 |
Warrants - Outstanding Warrants
Warrants - Outstanding Warrants To Purchase Common Stock Warrants (Detail) - Common Stock [Member] | 3 Months Ended |
Mar. 31, 2019$ / sharesshares | |
Class Of Warrant Or Right [Line Items] | |
Number of Shares Underlying Warrants | 530,627 |
Class Of Warrant Or Right Issued on August 2009 [Member] | |
Class Of Warrant Or Right [Line Items] | |
Issue Date | 2009-08 |
Classified as | Equity |
Exercise Price | $ / shares | $ 21.78 |
Number of Shares Underlying Warrants | 33,473 |
Class Of Warrant Or Right Issued on August 2009 [Member] | Remaining Term (in Years) [Member] | |
Class Of Warrant Or Right [Line Items] | |
Original Term | 10 years |
Class Of Warrant Or Right Issued on July 2010 [Member] | |
Class Of Warrant Or Right [Line Items] | |
Issue Date | 2010-07 |
Classified as | Equity |
Exercise Price | $ / shares | $ 21.78 |
Number of Shares Underlying Warrants | 6,694 |
Class Of Warrant Or Right Issued on July 2010 [Member] | Remaining Term (in Years) [Member] | |
Class Of Warrant Or Right [Line Items] | |
Original Term | 9 years |
Class Of Warrant Or Right Issued on August 2012 [Member] | |
Class Of Warrant Or Right [Line Items] | |
Issue Date | 2012-08 |
Classified as | Equity |
Exercise Price | $ / shares | $ 21.78 |
Number of Shares Underlying Warrants | 111,455 |
Class Of Warrant Or Right Issued on August 2012 [Member] | Remaining Term (in Years) [Member] | |
Class Of Warrant Or Right [Line Items] | |
Original Term | 7 years |
Class Of Warrant Or Right Issued on January 2015 [Member] | |
Class Of Warrant Or Right [Line Items] | |
Issue Date | 2015-01 |
Classified as | Equity |
Exercise Price | $ / shares | $ 6.96 |
Number of Shares Underlying Warrants | 34,483 |
Class Of Warrant Or Right Issued on January 2015 [Member] | Remaining Term (in Years) [Member] | |
Class Of Warrant Or Right [Line Items] | |
Original Term | 5 years |
Class Of Warrant Or Right Issued on April 2016 [Member] | |
Class Of Warrant Or Right [Line Items] | |
Issue Date | 2016-04 |
Classified as | Liability |
Exercise Price | $ / shares | $ 1.12 |
Number of Shares Underlying Warrants | 323,021 |
Class Of Warrant Or Right Issued on April 2016 [Member] | Remaining Term (in Years) [Member] | |
Class Of Warrant Or Right [Line Items] | |
Original Term | 7 years |
Class Of Warrant Or Right Issued on April 2016 [Member] | |
Class Of Warrant Or Right [Line Items] | |
Issue Date | 2016-04 |
Classified as | Liability |
Exercise Price | $ / shares | $ 1.12 |
Number of Shares Underlying Warrants | 21,501 |
Class Of Warrant Or Right Issued on April 2016 [Member] | Remaining Term (in Years) [Member] | |
Class Of Warrant Or Right [Line Items] | |
Original Term | 5 years |
Stock Incentive Plans - Summary
Stock Incentive Plans - Summary of Option, Unvested RSU Activity under 2014 Equity Incentive Plan and 2016 Inducement Equity Incentive Plan and Related Information (Detail) | 3 Months Ended |
Mar. 31, 2019$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Shares Available for Grant, Beginning Balance | 322,178 |
Shares Available for Grant, Additional options authorized | 1,655,398 |
Shares Available for Grant, Common stock awards for services | (2,112) |
Shares Available for Grant, Options granted | (341,900) |
Shares Available for Grant, Options exercised | 0 |
Shares Available for Grant, Repurchases of common stock under employee incentive plans | 83,923 |
Shares Available for Grant, RSUs forfeited | 24,726 |
Shares Available for Grant, Options forfeited | 54,096 |
Shares Available for Grant, Options expired | 710 |
Shares Available for Grant, Ending Balance | 1,429,219 |
Number of Shares, Beginning Balance | 2,501,057 |
Number of Shares, Additional options authorized | 0 |
Number of Shares, Options granted | 341,900 |
Number of Shares, Options exercised | (251,739) |
Number of Shares, Options forfeited | (54,096) |
Number of Shares, Options expired | (710) |
Number of Shares, Ending Balance | 2,536,412 |
Weighted-Average Exercise Price, Beginning Balance | $ / shares | $ 9.10 |
Weighted-Average Exercise Price, Additional options authorized | $ / shares | 0 |
Weighted-Average Exercise Price, Options granted | $ / shares | 27.52 |
Weighted-Average Exercise Price, Options exercised | $ / shares | 5.43 |
Weighted-Average Exercise Price, Options forfeited | $ / shares | 11.53 |
Weighted-Average Exercise Price, Options expired | $ / shares | 4.37 |
Weighted-Average Exercise Price, Ending Balance | $ / shares | $ 11.89 |
Number of RSU Shares, forfeited | (24,726) |
Restricted Stock Units (RSUs) [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Shares Available for Grant | (367,800) |
Number of RSU Shares, vested | (276,954) |
Shares Available for Grant, RSUs forfeited | 24,726 |
Number of RSU Shares, Beginning Balance | 968,364 |
Shares Available for Grant | 367,800 |
Number of RSU Shares, forfeited | (24,726) |
Number of RSU Shares, Ending Balance | 1,034,484 |
Weighted Average Grant- Date Fair Value, Unvested beginning balance | $ / shares | $ 11.49 |
Weighted- Average Grant Date Fair Value, RSUs granted | $ / shares | 27.21 |
Weighted- Average Grant Date Fair Value, RSUs vested | $ / shares | 13.53 |
Weighted- Average Grant Date Fair Value, RSUs forfeited | $ / shares | 15.24 |
Weighted Average Grant- Date Fair Value, Unvested ending balance | $ / shares | $ 16.41 |
Stock Incentive Plans - Additio
Stock Incentive Plans - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended |
Mar. 31, 2019 | Jun. 30, 2018 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Total intrinsic value of options exercised | $ 6,000,000 | ||
Share-based compensation expense, tax benefit recognized | 0 | ||
Share-based compensation expense, capitalized | 0 | ||
2014 Employee Stock Purchase Plan [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Maximum value of shares which an employee can purchase per calendar year | $ 25,000 | ||
Applicable exercise date an offering period shall be equal to percentage of the lower of fair market value of common stock | 85.00% | ||
Offering period for employee stock purchases | 6 months | ||
Aggregate proceeds from the issuance of shares | $ 300,000 | $ 300,000 | |
Shares issued under ESPP | 42,534 | 31,184 | |
2014 Employee Stock Purchase Plan [Member] | Maximum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Maximum portion of earning an employee may contribute to the ESPP Plan | 15.00% | ||
Restricted Stock Units (RSUs) [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Intrinsic value of RSUs | $ 32,600,000 | ||
Total unrecognized compensation costs related to stock options and RSUs | $ 13,500,000 | ||
Stock options and RSUs expected weighted average period | 2 years 8 months 19 days | ||
Stock Options [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock options and RSUs expected weighted average period | 3 years 5 months 19 days | ||
Total unrecognized compensation costs related to stock options | $ 13,100,000 | ||
Total fair value of options vested during period | $ 500,000 |
Stock Incentive Plans - Summa_2
Stock Incentive Plans - Summary of Options Outstanding Vested and Expected to Vest (Detail) $ / shares in Units, $ in Thousands | 3 Months Ended |
Mar. 31, 2019USD ($)$ / sharesshares | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Number of Shares, Vested | shares | 938,223 |
Number of Shares, Expected to vest | shares | 1,491,586 |
Number of Shares, Total | shares | 2,429,809 |
Weighted-average Exercise Price, Vested | $ / shares | $ 5.41 |
Weighted-average Exercise Price, Expected to vest | $ / shares | $ 15.70 |
Weighted-average Remaining Contractual Life (Years), Vested | 6 years 6 months 21 days |
Weighted-average Remaining Contractual Life (Years), Expected to vest | 9 years 2 months 1 day |
Aggregate Intrinsic Value, Vested | $ | $ 24,497 |
Aggregate Intrinsic Value, Expected to vest | $ | 23,598 |
Aggregate Intrinsic Value, Total | $ | $ 48,095 |
Stock Incentive Plans - Weighte
Stock Incentive Plans - Weighted-Average Assumptions Used to Estimated Fair Values of Share-Based Awards (Detail) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Shares of common stock subject to outstanding options [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (in years) | 6 years | 6 years |
Expected volatility | 70.33% | 79.96% |
Risk-free interest rate | 2.57% | 2.51% |
Expected dividend yield | 0.00% | 0.00% |
Employee Stock Purchase Plan [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (in years) | 6 months | 6 months |
Expected volatility | 76.66% | 105.32% |
Risk-free interest rate | 2.51% | 1.61% |
Expected dividend yield | 0.00% | 0.00% |
Stock Incentive Plans - Summa_3
Stock Incentive Plans - Summary of Expense Relating to Employee and Nonemployee Stock-Based Payment Awards from Stock Options and RSUs (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share based compensation, Total expensed | $ 6,053 | $ 706 |
Cost of testing [Member] | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share based compensation, Total expensed | 776 | 61 |
Research and Development Expense [Member] | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share based compensation, Total expensed | 832 | 213 |
Sales and marketing [Member] | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share based compensation, Total expensed | 727 | 64 |
General and administrative [Member] | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share based compensation, Total expensed | $ 3,718 | $ 368 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |||
Benefit for income taxes | $ 606 | $ 424 | |
GILTI tax rate | 10.50% |
Segment Reporting - Additional
Segment Reporting - Additional Information (Detail) | 3 Months Ended |
Mar. 31, 2019Segment | |
Segment Reporting [Abstract] | |
Number of reportable segments | 1 |
Segment Reporting - Reportable
Segment Reporting - Reportable Revenues by Geographic Regions (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Segment Reporting Information [Line Items] | ||
Revenues | $ 25,982 | $ 14,053 |
United States [Member] | ||
Segment Reporting Information [Line Items] | ||
Revenues | 23,240 | 11,447 |
Rest of The World [Member] | ||
Segment Reporting Information [Line Items] | ||
Revenues | 790 | 633 |
Europe [Member] | ||
Segment Reporting Information [Line Items] | ||
Revenues | 1,952 | 1,973 |
Testing Services [Member] | ||
Segment Reporting Information [Line Items] | ||
Revenues | 21,518 | 10,604 |
Testing Services [Member] | United States [Member] | ||
Segment Reporting Information [Line Items] | ||
Revenues | 21,386 | 10,460 |
Testing Services [Member] | Rest of The World [Member] | ||
Segment Reporting Information [Line Items] | ||
Revenues | 132 | 144 |
Product [Member] | ||
Segment Reporting Information [Line Items] | ||
Revenues | 4,433 | 3,307 |
Product [Member] | United States [Member] | ||
Segment Reporting Information [Line Items] | ||
Revenues | 1,832 | 845 |
Product [Member] | Rest of The World [Member] | ||
Segment Reporting Information [Line Items] | ||
Revenues | 658 | 489 |
Product [Member] | Europe [Member] | ||
Segment Reporting Information [Line Items] | ||
Revenues | 1,943 | 1,973 |
License and Other [Member] | ||
Segment Reporting Information [Line Items] | ||
Revenues | 31 | 142 |
License and Other [Member] | United States [Member] | ||
Segment Reporting Information [Line Items] | ||
Revenues | 22 | $ 142 |
License and Other [Member] | Europe [Member] | ||
Segment Reporting Information [Line Items] | ||
Revenues | $ 9 |
Segment Reporting - Long-Lived
Segment Reporting - Long-Lived Assets Consisting of Property and Equipment, Net by Geographic Regions (Detail) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Segment Reporting Information [Line Items] | ||
Long-lived assets | $ 3,820 | $ 4,134 |
United States [Member] | ||
Segment Reporting Information [Line Items] | ||
Long-lived assets | 2,985 | 3,235 |
Europe [Member] | ||
Segment Reporting Information [Line Items] | ||
Long-lived assets | 548 | 625 |
Rest of The World [Member] | ||
Segment Reporting Information [Line Items] | ||
Long-lived assets | $ 287 | $ 274 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) - Subsequent Event [Member] - OTTR Complete Transplant Management [Member] $ in Millions | May 07, 2019Center | May 07, 2019USD ($) |
Subsequent Event [Line Items] | ||
Cash consideration | $ | $ 16 | |
Percentage of outstanding equity to be acquired | 100.00% | 100.00% |
Acquisition, closing date | May 7, 2019 | |
Number of leading transplant centers | Center | 60 |