OraSure (OSUR) 10-Q 6 Nov 15 2015 Q3 Quarterly report Financial data

Document and Entity Information

Document and Entity Information - shares	9 Months Ended
	Sep. 30, 2015	Nov. 03, 2015
Document And Entity Information [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Period End Date	Sep. 30, 2015
Document Fiscal Year Focus	2,015
Document Fiscal Period Focus	Q3
Trading Symbol	OSUR
Entity Registrant Name	ORASURE TECHNOLOGIES INC
Entity Central Index Key	1,116,463
Current Fiscal Year End Date	--12-31
Entity Filer Category	Accelerated Filer
Entity Common Stock, Shares Outstanding		56,482,384

Consolidated Balance Sheets

Consolidated Balance Sheets - USD ($) $ in Thousands	Sep. 30, 2015	Dec. 31, 2014
CURRENT ASSETS:
Cash	$ 100,677	$ 92,867
Short-term investments	7,512	5,000
Accounts receivable, net of allowance for doubtful accounts of $608 and $533	17,089	16,138
Inventories	14,985	15,763
Prepaid expenses	1,400	1,140
Other current assets	159	306
Total current assets	141,822	131,214
PROPERTY AND EQUIPMENT, net	17,800	17,934
INTANGIBLE ASSETS, net	13,661	17,505
GOODWILL	18,974	21,734
OTHER ASSETS	1,589	1,246
TOTAL ASSETS	193,846	189,633
CURRENT LIABILITIES:
Accounts payable	6,964	7,148
Deferred revenue	13,302	8,043
Deferred income taxes	122	139
Accrued expenses	9,307	11,132
Total current liabilities	29,695	26,462
OTHER LIABILITIES	1,142	1,234
DEFERRED INCOME TAXES	$ 3,010	$ 3,236
COMMITMENTS AND CONTINGENCIES (Note 6)
STOCKHOLDERS' EQUITY
Preferred stock, par value $.000001, 25,000 shares authorized, none issued
Common stock, par value $.000001, 120,000 shares authorized, 56,482 and 56,187 shares issued and outstanding	$ 0	$ 0
Additional paid-in capital	348,677	344,894
Accumulated other comprehensive loss	(13,884)	(7,848)
Accumulated deficit	(174,794)	(178,345)
Total stockholders' equity	159,999	158,701
Total liabilities and stockholders' equity	$ 193,846	$ 189,633

Consolidated Balance Sheets (Pa

Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands	Sep. 30, 2015	Dec. 31, 2014
Statement of Financial Position [Abstract]
Allowance for doubtful accounts	$ 608	$ 533
Preferred stock, par value	$ 0.000001	$ 0.000001
Preferred stock, shares authorized	25,000,000	25,000,000
Preferred stock, shares issued	0	0
Common stock, par value	$ 0.000001	$ 0.000001
Common stock, shares authorized	120,000,000	120,000,000
Common stock, shares issued	56,482,000	56,187,000
Common stock, shares outstanding	56,482,000	56,187,000

Consolidated Statements of Oper

Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2015	Sep. 30, 2014	Sep. 30, 2015	Sep. 30, 2014
NET REVENUES:
Product	$ 25,714	$ 24,447	$ 75,792	$ 73,610
Other	4,147	3,398	11,545	4,173
Total revenue	29,861	27,845	87,337	77,783
COST OF PRODUCTS SOLD	9,192	9,140	28,974	29,135
Gross profit	20,669	18,705	58,363	48,648
OPERATING EXPENSES:
Research and development	2,525	2,990	8,961	8,242
Sales and marketing	9,677	9,216	26,465	30,828
General and administrative	6,931	5,617	18,971	17,317
Gain on contract termination settlement				(5,500)
Total operating expenses	19,133	17,823	54,397	50,887
Operating income (loss)	1,536	882	3,966	(2,239)
OTHER INCOME	81	268	395	244
Income (loss) before income taxes	1,617	1,150	4,361	(1,995)
INCOME TAX EXPENSE (BENEFIT)	147	10	810	(33)
NET INCOME (LOSS)	$ 1,470	$ 1,140	$ 3,551	$ (1,962)
EARNINGS (LOSS) PER SHARE:
BASIC	$ 0.03	$ 0.02	$ 0.06	$ (0.04)
DILUTED	$ 0.03	$ 0.02	$ 0.06	$ (0.04)
SHARES USED IN COMPUTING EARNINGS (LOSS) PER SHARE:
BASIC	56,482	56,018	56,427	55,897
DILUTED	56,692	56,666	56,900	55,897

Consolidated Statements of Comp

Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2015	Sep. 30, 2014	Sep. 30, 2015	Sep. 30, 2014
Statement of Comprehensive Income [Abstract]
NET INCOME (LOSS)	$ 1,470	$ 1,140	$ 3,551	$ (1,962)
OTHER COMPREHENSIVE LOSS
Currency translation adjustments	(2,858)	(2,295)	(6,036)	(2,451)
Other comprehensive loss	(2,858)	(2,295)	(6,036)	(2,451)
COMPREHENSIVE LOSS	$ (1,388)	$ (1,155)	$ (2,485)	$ (4,413)

Consolidated Statements of Cash

Consolidated Statements of Cash Flows - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2015	Sep. 30, 2014
OPERATING ACTIVITIES:
NET INCOME (LOSS)	$ 3,551	$ (1,962)
Adjustments to reconcile net income (loss) to net cash provided by operating activities:
Stock-based compensation	4,543	4,284
Depreciation and amortization	4,259	4,732
Unrealized foreign currency loss (gain)	450	(73)
Deferred income taxes	198	(33)
Changes in assets and liabilities
Accounts receivable	(1,572)	(2,111)
Inventories	633	(3,444)
Prepaid expenses and other assets	(614)	576
Accounts payable	(72)	(284)
Deferred revenue	5,269	10,433
Accrued expenses and other liabilities	(1,540)	(3,734)
Net cash provided by operating activities	15,105	8,384
INVESTING ACTIVITIES:
Purchases of short-term investments	(19,411)	(9,407)
Proceeds from maturities of short-term investments	16,450	4,432
Purchases of property and equipment	(1,885)	(2,353)
Net cash used in investing activities	(4,846)	(7,328)
FINANCING ACTIVITIES:
Proceeds from exercise of stock options	124	546
Repurchase of common stock	(883)	(639)
Net cash used in financing activities	(759)	(93)
EFFECT OF FOREIGN EXCHANGE RATE CHANGES ON CASH	(1,690)	(299)
NET INCREASE IN CASH	7,810	664
CASH, BEGINNING OF PERIOD	92,867	93,191
CASH, END OF PERIOD	100,677	93,855
Cash paid for:
Income taxes	$ 230	$ 42

The Company

The Company	9 Months Ended
	Sep. 30, 2015
Organization, Consolidation and Presentation of Financial Statements [Abstract]
The Company	1. The Company We develop, manufacture, market and sell diagnostic products and specimen collection devices using our proprietary technologies, as well as other diagnostic products, including immunoassays and other in vitro

Summary of Significant Accounti

Summary of Significant Accounting Policies	9 Months Ended
	Sep. 30, 2015
Accounting Policies [Abstract]
Summary of Significant Accounting Policies	2. Summary of Significant Accounting Policies Principles of Consolidation and Basis of Presentation The accompanying consolidated financial statements are unaudited and, in the opinion of management, include all adjustments (consisting only of normal and recurring adjustments) necessary for a fair presentation of our financial position and results of operations for these interim periods. These financial statements should be read in conjunction with the financial statements and notes thereto included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2014. Results of operations for the three and nine months ended September 30, 2015 are not necessarily indicative of the results of operations expected for the full year. Use of Estimates Short-Term Investments Our available-for-sale securities as of September 30, 2015 and December 31, 2014 consisted of guaranteed investment certificates with amortized cost and fair values of $7,512 and $5,000, respectively. Fair Value of Financial Instruments Fair value measurements of all financial assets and liabilities that are being measured and reported on a fair value basis are required to be classified and disclosed in one of the following three categories: Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities; Level 2: Quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability; and Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity). We offer a nonqualified deferred compensation plan for certain eligible employees and members of our Board of Directors. The assets of the plan are held in the name of the Company at a third-party financial institution. Separate accounts are maintained for each participant to reflect the amounts deferred by the participant and all earnings and losses on those deferred amounts. The assets of the plan are held in mutual funds and Company stock. The fair value of the plan assets as of September 30, 2015 and December 31, 2014 was $1,142 and $1,234, respectively, and was calculated using the quoted market prices of the assets as of those dates. All investments in the plan are classified as trading securities and measured as Level 1 instruments. The fair value of plan assets is included in other assets with the same amount included in other liabilities in the accompanying consolidated balance sheets. All of our available-for-sale securities are measured as Level 1 instruments as of September 30, 2015 and December 31, 2014. Inventories September 30, 2015 December 31, 2014 Raw materials $ 7,549 $ 8,539 Work in process 539 898 Finished goods 6,897 6,326 $ 14,985 $ 15,763 Prepaid Expenses and Other Noncurrent Assets ® ® Property and Equipment Intangible Assets September 30, 2015 Amortization Gross Accumulated Net Customer list 10 $ 9,410 $ (3,741 ) $ 5,669 Patents and product rights 3-10 10,449 (8,294 ) 2,155 Acquired technology 7 7,309 (4,088 ) 3,221 Tradename 15 3,607 (991 ) 2,616 $ 30,775 $ (17,114 ) $ 13,661 December 31, 2014 Amortization Gross Accumulated Net Customer list 10 $ 10,779 $ (3,508 ) $ 7,271 Patents and product rights 3-10 10,449 (7,957 ) 2,492 Acquired technology 7 8,372 (3,833 ) 4,539 Tradename 15 4,132 (929 ) 3,203 $ 33,732 $ (16,227 ) $ 17,505 Goodwill We performed our last annual impairment assessment as of July 31, 2015 utilizing a qualitative evaluation and concluded that it was more likely than not that the fair value of our DNAG reporting unit is greater than its carrying amount. We believe we have made reasonable estimates and assumptions to calculate the fair value of our reporting unit. If actual future results are not consistent with management’s estimates and assumptions, we may have to take an impairment charge in the future related to our goodwill. Future impairment tests will continue to be performed annually in the fiscal third quarter, or sooner if a triggering event occurs. As of September 30, 2015, we believe no indicators of impairment exist. The change in goodwill from $21,734 as of December 31, 2014 to $18,974 as of September 30, 2015 is a result of foreign currency translation. Revenue Recognition ® Our net revenues recorded on sales of the OraQuick ® We record shipping and handling charges billed to our customers as product revenue and the related expense as cost of products sold. Taxes assessed by governmental authorities, such as sales or value-added taxes, are excluded from product revenues. On June 10, 2014, we entered into a Master Program Services and Co-Promotion Agreement with AbbVie Bahamas Ltd., a wholly-owned subsidiary of AbbVie Inc. (“AbbVie”), to co-promote our OraQuick ® Pursuant to the Co-Promotion Agreement, we have granted exclusive co-promotion rights for the OraQuick ® ® ® Under the terms of this agreement, which runs through December 31, 2019, we are eligible to receive up to $75,000 in aggregate payments. We are recognizing these payments ratably on a monthly basis over the term of the agreement. During the third quarter of 2015, $3,397 in exclusivity payments were recognized. In addition, if certain performance-based milestones are achieved, we may be eligible to receive additional milestone payments. These payments would be based upon the aggregate number of new patients enrolled in the patient care database, in a given calendar year, after exceeding a baseline threshold, and could range from $3,500 to $55,500 annually over the term of the agreement. The first performance-based milestone period ends on December 31, 2015, but it is unlikely that a milestone will be achieved during this period. The agreement also contains certain termination, indemnification and other provisions, typical of agreements of this type. Amounts related to this agreement are recorded as other revenue in our statements of operations. On June 12, 2015, we were awarded a contract for up to $10,400 in total funding from the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response’s Biomedical Advanced Research and Development Authority (BARDA) related to our OraQuick ® ® Customer Sales Returns and Allowances ® ® Deferred Revenue Customer and Vendor Concentrations We currently purchase certain products and critical components of our products from sole-supply vendors. If these vendors are unable or unwilling to supply the required components and products, we could be subject to increased costs and substantial delays in the delivery of our products to our customers. Also, our subsidiary, DNAG, uses two third-party suppliers to manufacture its products. Our inability to have a timely supply of any of these components and products could have a material adverse effect on our business, as well as our financial condition and results of operations. Earnings (Loss) Per Share The computations of basic and diluted earnings (loss) per share are as follows: Three Months Nine Months Ended September 30, Ended September 30, 2015 2014 2015 2014 Net income (loss) $ 1,470 $ 1,140 $ 3,551 $ (1,962 ) Weighted average shares of common stock outstanding: Basic 56,482 56,018 56,427 55,897 Dilutive effect of stock options and restricted stock 210 648 473 — Diluted 56,692 56,666 56,900 55,897 Earnings (loss) per share: Basic $ 0.03 $ 0.02 $ 0.06 $ (0.04 ) Diluted $ 0.03 $ 0.02 $ 0.06 $ (0.04 ) For the three-month periods ended September 30, 2015 and 2014, outstanding common stock options and unvested restricted stock, representing 6,231 and 2,647 shares, respectively, were excluded from the computation of diluted earnings per share as their inclusion would have been anti-dilutive. For the nine months ended September 30, 2015 and 2014, outstanding common stock options and unvested restricted stock, representing 4,648 and 3,313 shares, respectively, were similarly excluded from the computation of diluted earnings (loss) per share. Foreign Currency Translation Transaction gains and losses resulting from exchange rate changes on transactions denominated in currencies other than functional currency are included in income in the period in which the change occurs. Accumulated Other Comprehensive Loss We have defined the Canadian dollar as the functional currency of our Canadian subsidiary, DNAG, and as such, the results of its operations are translated into U.S. dollars, which is the reporting currency of the Company. The $6,036 and $2,451 currency translation adjustments recorded in the first nine months of 2015 and 2014, respectively, are largely the result of the translation of our Canadian operation’s balance sheets into U.S. dollars. Recent Accounting Pronouncements Revenue from Contracts with Customers In July 2015, the FASB issues ASU 2015-11, Simplifying the Measurement of Inventory

Stockholders' Equity

Stockholders' Equity	9 Months Ended
	Sep. 30, 2015
Equity [Abstract]
Stockholders' Equity	3. Stockholders’ Equity Stock-Based Awards We grant stock-based awards under the OraSure Technologies, Inc. Stock Award Plan, as amended and restated (the “Stock Plan”). The Stock Plan permits stock-based awards to employees, outside directors and consultants or other third-party advisors. Awards which may be granted under the Stock Plan include qualified incentive stock options, nonqualified stock options, stock appreciation rights, restricted awards, performance awards and other stock-based awards. We recognize compensation expense for stock option and restricted stock awards issued to employees and directors on a straight-line basis over the requisite service period of the award. To satisfy the exercise of options or vesting of restricted stock, we issue new shares rather than purchase shares on the open market. Total compensation cost related to stock options for the nine months ended September 30, 2015 and 2014 was $2,557 and $2,286, respectively. Net cash proceeds from the exercise of stock options were $124 and $546 for the nine months ended September 30, 2015 and 2014, respectively. As a result of the Company’s net operating loss carryforward position, no actual income tax benefit was realized from stock option exercises during these periods. Compensation cost of $1,986 and $1,998 related to restricted shares was recognized during the nine months ended September 30, 2015 and 2014, respectively. In connection with the vesting of restricted shares and exercise of stock options during the nine months ended September 30, 2015 and 2014, we purchased and immediately retired 132 and 106 shares with aggregate values of $883 and $639, respectively, in satisfaction of minimum tax withholding and exercise obligations.

Accrued Expenses

Accrued Expenses	9 Months Ended
	Sep. 30, 2015
Payables and Accruals [Abstract]
Accrued Expenses	4. Accrued Expenses September 30, 2015 December 31, 2014 Payroll and related benefits $ 5,493 $ 6,620 Professional fees 1,076 480 Royalties 618 2,285 Other 2,120 1,747 $ 9,307 $ 11,132

Income Taxes

Income Taxes	9 Months Ended
	Sep. 30, 2015
Income Tax Disclosure [Abstract]
Income Taxes	5. Income Taxes During the three and nine months ended September 30, 2015, we recorded foreign tax expense of $147 and $810, respectively. Foreign taxes during the three and nine months ended September 30, 2015 includes $168 of deferred tax benefits and $198 of deferred tax expense, respectively. Foreign taxes for the three and nine months ended September 30, 2015 also include $315 and $612, respectively, of current tax expense associated with amounts payable for provincial taxes. During the three and nine months ended September 30, 2014, we recorded foreign deferred tax expense of $10 and foreign deferred tax benefits of $33, respectively. Deferred income taxes reflect the tax effects of temporary differences between the basis of assets and liabilities recognized for financial reporting and tax purposes, and net operating loss and tax credit carryforwards. The significant components of our total deferred tax liability as of September 30, 2015 relate to the tax effects of the basis differences between the intangible assets acquired in the DNAG acquisition for financial reporting and tax purposes. In 2008, we established a full valuation allowance against our U.S. deferred tax asset. Management believes the full valuation allowance is still appropriate as of September 30, 2015 and December 31, 2014 since the facts and circumstances necessitating the allowance have not changed. As a result, no U.S. federal or state income tax benefit was recorded for the three and nine-month periods ended September 30, 2015 and 2014.

Commitments and Contingencies

Commitments and Contingencies	9 Months Ended
	Sep. 30, 2015
Commitments and Contingencies Disclosure [Abstract]
Commitments and Contingencies	6. Commitments and Contingencies From time-to-time, we are involved in certain legal actions arising in the ordinary course of business. In management’s opinion, based upon the advice of counsel, the outcomes of such actions are not expected, individually or in the aggregate, to have a material adverse effect on our future financial position or results of operations.

Business Segment Information

Business Segment Information	9 Months Ended
	Sep. 30, 2015
Segment Reporting [Abstract]
Business Segment Information	7. Business Segment Information We operate our business within two reportable segments: our “OSUR” business, which consists of the development, manufacture and sale of diagnostic products, specimen collection devices and medical devices; and our molecular collection systems or “DNAG” business, which primarily consists of the manufacture, development and sale of oral fluid collection devices that are used to collect, stabilize and store samples of genetic material for molecular testing. OSUR revenues are derived primarily from products sold in the United States and internationally to various clinical laboratories, hospitals, clinics, community-based organizations, public health organizations, distributors, government agencies, physicians’ offices, commercial and industrial entities, retail pharmacies, mass merchandisers, and to consumers over the internet. OSUR also derives other revenues, including exclusivity payments for co-promotion rights and other licensing and product development activities. DNAG revenues result primarily from products sold into the commercial market which consists of customers engaged in consumer genetics, clinical genetic testing, pharmacogenomics, personalized medicine, and animal and livestock genetic testing. DNAG products are also sold into the academic research market, which consists of research laboratories, universities and hospitals. We organized our operating segments according to the nature of the products included in those segments. The accounting policies of the segments are the same as those described in the summary of significant accounting policies (see Note 2). We evaluate performance of our operating segments based on revenue and operating income (loss). We do not allocate interest income, interest expense, other income, other expenses or income taxes to our operating segments. Reportable segments have no inter-segment revenues. The following table summarizes operating segment information for the three and nine months ended September 30, 2015 and 2014, and asset information as of September 30, 2015 and December 31, 2014: Three Months Ended Nine Months Ended 2015 2014 2015 2014 Net revenues: OSUR $ 22,532 $ 20,978 $ 65,189 $ 60,260 DNAG 7,329 6,867 22,148 17,523 Total $ 29,861 $ 27,845 $ 87,337 $ 77,783 Operating income (loss): OSUR $ 725 $ (987 ) $ (111 ) $ (5,177 ) DNAG 811 1,869 4,077 2,938 Total $ 1,536 $ 882 $ 3,966 $ (2,239 ) Depreciation and amortization: OSUR $ 764 $ 820 $ 2,224 $ 2,386 DNAG 646 804 2,035 2,346 Total $ 1,410 $ 1,624 $ 4,259 $ 4,732 Capital expenditures: OSUR $ 536 $ 298 $ 1,102 $ 1,868 DNAG 204 67 783 485 Total $ 740 $ 365 $ 1,885 $ 2,353 September 30, 2015 December 31, 2014 Total assets: OSUR $ 141,506 $ 136,542 DNAG 52,340 53,091 Total $ 193,846 $ 189,633 Our products are sold principally in the United States and Europe. The following table represents total revenues by geographic area, based on the location of the customer: Three Months Ended Nine Months Ended 2015 2014 2015 2014 United States $ 24,207 $ 22,469 $ 69,695 $ 58,987 Europe 2,738 3,252 10,051 10,935 Other regions 2,916 2,124 7,591 7,861 $ 29,861 $ 27,845 $ 87,337 $ 77,783 The following table represents total long-lived assets by geographic area: September 30, 2015 December 31, 2014 United States $ 15,866 $ 16,570 Canada 1,923 1,353 Other regions 11 11 $ 17,800 $ 17,934

Summary of Significant Accoun14

Summary of Significant Accounting Policies (Policies)	9 Months Ended
	Sep. 30, 2015
Accounting Policies [Abstract]
Principles of Consolidation and Basis of Presentation	Principles of Consolidation and Basis of Presentation The accompanying consolidated financial statements are unaudited and, in the opinion of management, include all adjustments (consisting only of normal and recurring adjustments) necessary for a fair presentation of our financial position and results of operations for these interim periods. These financial statements should be read in conjunction with the financial statements and notes thereto included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2014. Results of operations for the three and nine months ended September 30, 2015 are not necessarily indicative of the results of operations expected for the full year.
Use of Estimates	Use of Estimates
Short-Term Investments	Short-Term Investments Our available-for-sale securities as of September 30, 2015 and December 31, 2014 consisted of guaranteed investment certificates with amortized cost and fair values of $7,512 and $5,000, respectively.
Fair Value of Financial Instruments	Fair Value of Financial Instruments Fair value measurements of all financial assets and liabilities that are being measured and reported on a fair value basis are required to be classified and disclosed in one of the following three categories: Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities; Level 2: Quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability; and Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity). We offer a nonqualified deferred compensation plan for certain eligible employees and members of our Board of Directors. The assets of the plan are held in the name of the Company at a third-party financial institution. Separate accounts are maintained for each participant to reflect the amounts deferred by the participant and all earnings and losses on those deferred amounts. The assets of the plan are held in mutual funds and Company stock. The fair value of the plan assets as of September 30, 2015 and December 31, 2014 was $1,142 and $1,234, respectively, and was calculated using the quoted market prices of the assets as of those dates. All investments in the plan are classified as trading securities and measured as Level 1 instruments. The fair value of plan assets is included in other assets with the same amount included in other liabilities in the accompanying consolidated balance sheets. All of our available-for-sale securities are measured as Level 1 instruments as of September 30, 2015 and December 31, 2014.
Inventories	Inventories September 30, 2015 December 31, 2014 Raw materials $ 7,549 $ 8,539 Work in process 539 898 Finished goods 6,897 6,326 $ 14,985 $ 15,763
Prepaid Expenses and Other Noncurrent Assets	Prepaid Expenses and Other Noncurrent Assets ® ®
Property and Equipment	Property and Equipment
Intangible Assets	Intangible Assets September 30, 2015 Amortization Gross Accumulated Net Customer list 10 $ 9,410 $ (3,741 ) $ 5,669 Patents and product rights 3-10 10,449 (8,294 ) 2,155 Acquired technology 7 7,309 (4,088 ) 3,221 Tradename 15 3,607 (991 ) 2,616 $ 30,775 $ (17,114 ) $ 13,661 December 31, 2014 Amortization Gross Accumulated Net Customer list 10 $ 10,779 $ (3,508 ) $ 7,271 Patents and product rights 3-10 10,449 (7,957 ) 2,492 Acquired technology 7 8,372 (3,833 ) 4,539 Tradename 15 4,132 (929 ) 3,203 $ 33,732 $ (16,227 ) $ 17,505
Goodwill	Goodwill We performed our last annual impairment assessment as of July 31, 2015 utilizing a qualitative evaluation and concluded that it was more likely than not that the fair value of our DNAG reporting unit is greater than its carrying amount. We believe we have made reasonable estimates and assumptions to calculate the fair value of our reporting unit. If actual future results are not consistent with management’s estimates and assumptions, we may have to take an impairment charge in the future related to our goodwill. Future impairment tests will continue to be performed annually in the fiscal third quarter, or sooner if a triggering event occurs. As of September 30, 2015, we believe no indicators of impairment exist. The change in goodwill from $21,734 as of December 31, 2014 to $18,974 as of September 30, 2015 is a result of foreign currency translation.
Revenue Recognition	Revenue Recognition ® Our net revenues recorded on sales of the OraQuick ® We record shipping and handling charges billed to our customers as product revenue and the related expense as cost of products sold. Taxes assessed by governmental authorities, such as sales or value-added taxes, are excluded from product revenues. On June 10, 2014, we entered into a Master Program Services and Co-Promotion Agreement with AbbVie Bahamas Ltd., a wholly-owned subsidiary of AbbVie Inc. (“AbbVie”), to co-promote our OraQuick ® Pursuant to the Co-Promotion Agreement, we have granted exclusive co-promotion rights for the OraQuick ® ® ® Under the terms of this agreement, which runs through December 31, 2019, we are eligible to receive up to $75,000 in aggregate payments. We are recognizing these payments ratably on a monthly basis over the term of the agreement. During the third quarter of 2015, $3,397 in exclusivity payments were recognized. In addition, if certain performance-based milestones are achieved, we may be eligible to receive additional milestone payments. These payments would be based upon the aggregate number of new patients enrolled in the patient care database, in a given calendar year, after exceeding a baseline threshold, and could range from $3,500 to $55,500 annually over the term of the agreement. The first performance-based milestone period ends on December 31, 2015, but it is unlikely that a milestone will be achieved during this period. The agreement also contains certain termination, indemnification and other provisions, typical of agreements of this type. Amounts related to this agreement are recorded as other revenue in our statements of operations. On June 12, 2015, we were awarded a contract for up to $10,400 in total funding from the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response’s Biomedical Advanced Research and Development Authority (BARDA) related to our OraQuick ® ®
Customer Sales Returns and Allowances	Customer Sales Returns and Allowances ® ®
Deferred Revenue	Deferred Revenue
Customer and Vendor Concentrations	Customer and Vendor Concentrations We currently purchase certain products and critical components of our products from sole-supply vendors. If these vendors are unable or unwilling to supply the required components and products, we could be subject to increased costs and substantial delays in the delivery of our products to our customers. Also, our subsidiary, DNAG, uses two third-party suppliers to manufacture its products. Our inability to have a timely supply of any of these components and products could have a material adverse effect on our business, as well as our financial condition and results of operations.
Earnings (Loss) Per Share	Earnings (Loss) Per Share The computations of basic and diluted earnings (loss) per share are as follows: Three Months Nine Months Ended September 30, Ended September 30, 2015 2014 2015 2014 Net income (loss) $ 1,470 $ 1,140 $ 3,551 $ (1,962 ) Weighted average shares of common stock outstanding: Basic 56,482 56,018 56,427 55,897 Dilutive effect of stock options and restricted stock 210 648 473 — Diluted 56,692 56,666 56,900 55,897 Earnings (loss) per share: Basic $ 0.03 $ 0.02 $ 0.06 $ (0.04 ) Diluted $ 0.03 $ 0.02 $ 0.06 $ (0.04 ) For the three-month periods ended September 30, 2015 and 2014, outstanding common stock options and unvested restricted stock, representing 6,231 and 2,647 shares, respectively, were excluded from the computation of diluted earnings per share as their inclusion would have been anti-dilutive. For the nine months ended September 30, 2015 and 2014, outstanding common stock options and unvested restricted stock, representing 4,648 and 3,313 shares, respectively, were similarly excluded from the computation of diluted earnings (loss) per share.
Foreign Currency Translation	Foreign Currency Translation Transaction gains and losses resulting from exchange rate changes on transactions denominated in currencies other than functional currency are included in income in the period in which the change occurs.
Accumulated Other Comprehensive Loss	Accumulated Other Comprehensive Loss We have defined the Canadian dollar as the functional currency of our Canadian subsidiary, DNAG, and as such, the results of its operations are translated into U.S. dollars, which is the reporting currency of the Company. The $6,036 and $2,451 currency translation adjustments recorded in the first nine months of 2015 and 2014, respectively, are largely the result of the translation of our Canadian operation’s balance sheets into U.S. dollars.
Recent Accounting Pronouncements	Recent Accounting Pronouncements Revenue from Contracts with Customers In July 2015, the FASB issues ASU 2015-11, Simplifying the Measurement of Inventory

Summary of Significant Accoun15

Summary of Significant Accounting Policies (Tables)	9 Months Ended
	Sep. 30, 2015
Accounting Policies [Abstract]
Schedule of Inventories	Inventories are stated at the lower of cost or market determined on a first-in, first-out basis and are comprised of the following: September 30, 2015 December 31, 2014 Raw materials $ 7,549 $ 8,539 Work in process 539 898 Finished goods 6,897 6,326 $ 14,985 $ 15,763
Summary of Intangible Assets	Intangible assets consist of the following: September 30, 2015 Amortization Gross Accumulated Net Customer list 10 $ 9,410 $ (3,741 ) $ 5,669 Patents and product rights 3-10 10,449 (8,294 ) 2,155 Acquired technology 7 7,309 (4,088 ) 3,221 Tradename 15 3,607 (991 ) 2,616 $ 30,775 $ (17,114 ) $ 13,661 December 31, 2014 Amortization Gross Accumulated Net Customer list 10 $ 10,779 $ (3,508 ) $ 7,271 Patents and product rights 3-10 10,449 (7,957 ) 2,492 Acquired technology 7 8,372 (3,833 ) 4,539 Tradename 15 4,132 (929 ) 3,203 $ 33,732 $ (16,227 ) $ 17,505
Computations of Basic and Diluted Earnings (Loss) per Share	The computations of basic and diluted earnings (loss) per share are as follows: Three Months Nine Months Ended September 30, Ended September 30, 2015 2014 2015 2014 Net income (loss) $ 1,470 $ 1,140 $ 3,551 $ (1,962 ) Weighted average shares of common stock outstanding: Basic 56,482 56,018 56,427 55,897 Dilutive effect of stock options and restricted stock 210 648 473 — Diluted 56,692 56,666 56,900 55,897 Earnings (loss) per share: Basic $ 0.03 $ 0.02 $ 0.06 $ (0.04 ) Diluted $ 0.03 $ 0.02 $ 0.06 $ (0.04 )

Accrued Expenses (Tables)

Accrued Expenses (Tables)	9 Months Ended
	Sep. 30, 2015
Payables and Accruals [Abstract]
Schedule of Accrued Expenses	September 30, 2015 December 31, 2014 Payroll and related benefits $ 5,493 $ 6,620 Professional fees 1,076 480 Royalties 618 2,285 Other 2,120 1,747 $ 9,307 $ 11,132

Business Segment Information (T

Business Segment Information (Tables)	9 Months Ended
	Sep. 30, 2015
Segment Reporting [Abstract]
Summary of Operating Segment and Asset Information	The following table summarizes operating segment information for the three and nine months ended September 30, 2015 and 2014, and asset information as of September 30, 2015 and December 31, 2014: Three Months Ended Nine Months Ended 2015 2014 2015 2014 Net revenues: OSUR $ 22,532 $ 20,978 $ 65,189 $ 60,260 DNAG 7,329 6,867 22,148 17,523 Total $ 29,861 $ 27,845 $ 87,337 $ 77,783 Operating income (loss): OSUR $ 725 $ (987 ) $ (111 ) $ (5,177 ) DNAG 811 1,869 4,077 2,938 Total $ 1,536 $ 882 $ 3,966 $ (2,239 ) Depreciation and amortization: OSUR $ 764 $ 820 $ 2,224 $ 2,386 DNAG 646 804 2,035 2,346 Total $ 1,410 $ 1,624 $ 4,259 $ 4,732 Capital expenditures: OSUR $ 536 $ 298 $ 1,102 $ 1,868 DNAG 204 67 783 485 Total $ 740 $ 365 $ 1,885 $ 2,353 September 30, 2015 December 31, 2014 Total assets: OSUR $ 141,506 $ 136,542 DNAG 52,340 53,091 Total $ 193,846 $ 189,633
Presentation of Total Revenues and Long-Lived Assets by Geographic Area	The following table represents total revenues by geographic area, based on the location of the customer: Three Months Ended Nine Months Ended 2015 2014 2015 2014 United States $ 24,207 $ 22,469 $ 69,695 $ 58,987 Europe 2,738 3,252 10,051 10,935 Other regions 2,916 2,124 7,591 7,861 $ 29,861 $ 27,845 $ 87,337 $ 77,783 The following table represents total long-lived assets by geographic area: September 30, 2015 December 31, 2014 United States $ 15,866 $ 16,570 Canada 1,923 1,353 Other regions 11 11 $ 17,800 $ 17,934

Summary of Significant Accoun18

Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) shares in Thousands	Jun. 12, 2015	Sep. 30, 2015	Sep. 30, 2015	Sep. 30, 2014	Sep. 30, 2015	Sep. 30, 2014	Dec. 31, 2014	Jun. 30, 2015
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Available-for-sale securities, fair values		$ 7,512,000	$ 7,512,000		$ 7,512,000		$ 5,000,000
Fair value of plan assets		1,142,000	1,142,000		1,142,000		1,234,000
Prepaid royalties								$ 1,100,000
Accumulated depreciation of property and equipment		33,252,000	33,252,000		33,252,000		31,416,000
Amount of goodwill at period end		18,974,000	18,974,000		$ 18,974,000		21,734,000
Expiration date of rights agreement					Dec. 31, 2019
Revenue recognition, milestone method description					We may be eligible to receive additional milestone payments. These payments would be based upon the aggregate number of new patients enrolled in the patient care database, in a given calendar year, after exceeding a baseline threshold, and could range from $3,500 to $55,500 annually over the term of the agreement. The first performance-based milestone period ends on December 31, 2015,
Maximum value of contract revenue from clinical and regulatory activities	$ 10,400,000
Initial contract revenue from clinical and regulatory activities	1,800,000
Remaining contract revenue from clinical and regulatory activities	$ 8,600,000
Period of contract	3 years
Additional contract revenue from clinical and regulatory activities		7,200,000
Reserve for sales return and allowances					$ 277,000		437,000
Deferred revenue		13,302,000	$ 13,302,000		$ 13,302,000		8,043,000
Number of anti-dilutive securities excluded from EPS computation			6,231	2,647	4,648	3,313
Accumulated foreign currency adjustments included in other comprehensive loss amounted		6,036,000	$ 6,036,000	$ 2,451,000	$ 6,036,000	$ 2,451,000
Up Front Payment Arrangement [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Deferred revenue		953,000	953,000		953,000		613,000
AbbVie [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Deferred revenue		12,349,000	$ 12,349,000		$ 12,349,000		$ 7,430,000
Customer One [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Percentage of concentration risk			11.00%				0.00%
Customer Two [Member] | Net Revenue [Member] | Customer Concentration Risk [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Percentage of concentration risk			11.00%	12.00%	12.00%	0.00%
Guaranteed Investment Certificates [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Available-for-sale securities, amortized cost		7,512,000	$ 7,512,000		$ 7,512,000		$ 7,512,000
Available-for-sale securities, fair values		$ 5,000,000	5,000,000		5,000,000		$ 5,000,000
Other [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Exclusivity payments recognized in lieu of sale of exclusive rights			3,397,000
Contract revenues from clinical and regulatory activities			$ 750,000
Maximum [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Payments received for sale of exclusive rights					75,000,000
Additional annual payments to be received for sale of exclusive rights					$ 55,500,000
Maximum [Member] | Buildings [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Estimated useful lives of assets					40 years
Maximum [Member] | Computer Equipment [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Estimated useful lives of assets					10 years
Maximum [Member] | Machinery and Equipment [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Estimated useful lives of assets					10 years
Maximum [Member] | Furniture and Fixtures [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Estimated useful lives of assets					10 years
Minimum [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Additional annual payments to be received for sale of exclusive rights					$ 3,500,000
Minimum [Member] | Buildings [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Estimated useful lives of assets					20 years
Minimum [Member] | Computer Equipment [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Estimated useful lives of assets					2 years
Minimum [Member] | Machinery and Equipment [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Estimated useful lives of assets					2 years
Minimum [Member] | Furniture and Fixtures [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Estimated useful lives of assets					2 years
DNA Genotek [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Number of third-party suppliers to manufacture DNAG's products					2

Summary of Significant Accoun19

Summary of Significant Accounting Policies - Schedule of Inventories (Detail) - USD ($) $ in Thousands	Sep. 30, 2015	Dec. 31, 2014
Inventory, Net [Abstract]
Raw materials	$ 7,549	$ 8,539
Work in process	539	898
Finished goods	6,897	6,326
Inventories	$ 14,985	$ 15,763

Summary of Significant Accoun20

Summary of Significant Accounting Policies - Summary of Intangible Assets (Detail) - USD ($) $ in Thousands	9 Months Ended	12 Months Ended
	Sep. 30, 2014	Dec. 31, 2014	Sep. 30, 2015
Finite-Lived Intangible Assets [Line Items]
Intangible Assets, Gross	$ 30,775	$ 33,732
Intangible Assets, Accumulated Amortization	(17,114)	(16,227)
Intangible Assets, Net	$ 13,661	$ 17,505	$ 13,661
Customer List [Member]
Finite-Lived Intangible Assets [Line Items]
Intangible Assets, Amortization Period (Years)	10 years	10 years
Intangible Assets, Gross	$ 9,410	$ 10,779
Intangible Assets, Accumulated Amortization	(3,741)	(3,508)
Intangible Assets, Net	5,669	7,271
Patents and Product Rights [Member]
Finite-Lived Intangible Assets [Line Items]
Intangible Assets, Gross	10,449	10,449
Intangible Assets, Accumulated Amortization	(8,294)	(7,957)
Intangible Assets, Net	$ 2,155	$ 2,492
Patents and Product Rights [Member] | Minimum [Member]
Finite-Lived Intangible Assets [Line Items]
Intangible Assets, Amortization Period (Years)	3 years	3 years
Patents and Product Rights [Member] | Maximum [Member]
Finite-Lived Intangible Assets [Line Items]
Intangible Assets, Amortization Period (Years)	10 years	10 years
Acquired Technology [Member]
Finite-Lived Intangible Assets [Line Items]
Intangible Assets, Amortization Period (Years)	7 years	7 years
Intangible Assets, Gross	$ 7,309	$ 8,372
Intangible Assets, Accumulated Amortization	(4,088)	(3,833)
Intangible Assets, Net	$ 3,221	$ 4,539
Tradename [Member]
Finite-Lived Intangible Assets [Line Items]
Intangible Assets, Amortization Period (Years)	15 years	15 years
Intangible Assets, Gross	$ 3,607	$ 4,132
Intangible Assets, Accumulated Amortization	(991)	(929)
Intangible Assets, Net	$ 2,616	$ 3,203

Summary of Significant Accoun21

Summary of Significant Accounting Policies - Computations of Basic and Diluted Earnings (Loss) per Share (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2015	Sep. 30, 2014	Sep. 30, 2015	Sep. 30, 2014
Earnings Per Share [Abstract]
NET INCOME (LOSS)	$ 1,470	$ 1,140	$ 3,551	$ (1,962)
Weighted average shares of common stock outstanding:
BASIC	56,482	56,018	56,427	55,897
Dilutive effect of stock options and restricted stock	210	648	473
Diluted	56,692	56,666	56,900	55,897
BASIC	$ 0.03	$ 0.02	$ 0.06	$ (0.04)
DILUTED	$ 0.03	$ 0.02	$ 0.06	$ (0.04)

Stockholders' Equity - Addition

Stockholders' Equity - Additional Information (Detail) - USD ($) shares in Thousands	9 Months Ended
	Sep. 30, 2015	Sep. 30, 2014
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation	$ 4,543,000	$ 4,284,000
Proceeds from exercise of stock options	124,000	546,000
Income tax benefit realized from stock option exercises during period	0	0
Stock Options [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation	2,557,000	2,286,000
Proceeds from exercise of stock options	124,000	546,000
Restricted Stock [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation	$ 1,986,000	$ 1,998,000
Vesting of restricted shares and exercise of stock options, withholding and exercise obligations	132	106
Restricted shares of common stock and stock options, aggregate values	$ 883,000	$ 639,000

Accrued Expenses - Schedule of

Accrued Expenses - Schedule of Accrued Expenses (Detail) - USD ($) $ in Thousands	Sep. 30, 2015	Dec. 31, 2014
Accrued Liabilities, Current [Abstract]
Payroll and related benefits	$ 5,493	$ 6,620
Professional fees	1,076	480
Royalties	618	2,285
Other	2,120	1,747
Accrued Expenses, Total	$ 9,307	$ 11,132

Income Taxes - Additional Infor

Income Taxes - Additional Information (Detail) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2015	Sep. 30, 2014	Sep. 30, 2015	Sep. 30, 2014
Income Tax Disclosure [Abstract]
Foreign tax expense	$ 147,000		$ 810,000
Foreign deferred tax expense (benefits)	(168,000)	$ 10,000	198,000	$ (33,000)
Foreign current tax expense (benefits)	315,000		612,000
U.S. federal income tax benefits	0	0	0	0
U.S. state income tax benefits	$ 0	$ 0	$ 0	$ 0

Business Segment Information -

Business Segment Information - Additional Information (Detail)	9 Months Ended
	Sep. 30, 2015Segment
Segment Reporting [Abstract]
Number of reportable segments of company	2

Business Segment Information 26

Business Segment Information - Summary of Operating Segment and Asset Information (Detail) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2015	Sep. 30, 2014	Sep. 30, 2015	Sep. 30, 2014	Dec. 31, 2014
Segment Reporting Information [Line Items]
Net revenues	$ 29,861	$ 27,845	$ 87,337	$ 77,783
Operating income (loss)	1,536	882	3,966	(2,239)
Depreciation and amortization	1,410	1,624	4,259	4,732
Capital expenditures	740	365	1,885	2,353
Total assets	193,846		193,846		$ 189,633
OSUR [Member]
Segment Reporting Information [Line Items]
Net revenues	22,532	20,978	65,189	60,260
Operating income (loss)	725	(987)	(111)	(5,177)
Depreciation and amortization	764	820	2,224	2,386
Capital expenditures	536	298	1,102	1,868
Total assets	141,506		141,506		136,542
DNAG [Member]
Segment Reporting Information [Line Items]
Net revenues	7,329	6,867	22,148	17,523
Operating income (loss)	811	1,869	4,077	2,938
Depreciation and amortization	646	804	2,035	2,346
Capital expenditures	204	$ 67	783	$ 485
Total assets	$ 52,340		$ 52,340		$ 53,091

Business Segment Information 27

Business Segment Information - Presentation of Total Revenues and Long-Lived Assets by Geographic Area (Detail) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2015	Sep. 30, 2014	Sep. 30, 2015	Sep. 30, 2014	Dec. 31, 2014
Segment Reporting, Revenue Reconciling Item [Line Items]
Revenues	$ 29,861	$ 27,845	$ 87,337	$ 77,783
Long-lived assets	17,800		17,800		$ 17,934
United States [Member]
Segment Reporting, Revenue Reconciling Item [Line Items]
Revenues	24,207	22,469	69,695	58,987
Long-lived assets	15,866		15,866		16,570
Europe [Member]
Segment Reporting, Revenue Reconciling Item [Line Items]
Revenues	2,738	3,252	10,051	10,935
Other Regions [Member]
Segment Reporting, Revenue Reconciling Item [Line Items]
Revenues	2,916	$ 2,124	7,591	$ 7,861
Long-lived assets	11		11		11
Canada [Member]
Segment Reporting, Revenue Reconciling Item [Line Items]
Long-lived assets	$ 1,923		$ 1,923		$ 1,353