Document And Entity Information
Document And Entity Information - shares | 6 Months Ended | |
Jun. 30, 2018 | Aug. 05, 2018 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2018 | |
Document Fiscal Year Focus | 2,018 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | insy | |
Entity Registrant Name | Insys Therapeutics, Inc. | |
Entity Central Index Key | 1,516,479 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding (in shares) | 74,244,874 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($) $ in Thousands | Jun. 30, 2018 | Dec. 31, 2017 |
Current Assets: | ||
Cash and cash equivalents | $ 16,090 | $ 31,999 |
Short-term investments | 88,813 | 85,189 |
Accounts receivable, net of allowances of $2,626 and $3,832 at June 30, 2018 and December 31, 2017, respectively | 20,067 | 21,513 |
Inventories, net | 10,001 | 17,408 |
Prepaid expenses and other current assets | 21,143 | 19,833 |
Total current assets | 156,114 | 175,942 |
Property and equipment, net | 52,892 | 55,174 |
Long-term investments | 18,605 | 46,733 |
Other assets | 7,534 | 1,231 |
Total assets | 235,145 | 279,080 |
Current Liabilities: | ||
Accounts payable and accrued expenses | 33,569 | 30,438 |
Accrued compensation | 5,322 | 8,808 |
Accrued sales allowances | 12,582 | 16,290 |
Deferred revenue | 1,109 | |
Accrued litigation award and settlements | 150,134 | 150,534 |
Total current liabilities | 201,607 | 207,179 |
Uncertain income tax positions | 8,901 | 8,619 |
Total liabilities | 210,508 | 215,798 |
Commitments and Contingencies (Note 7) | ||
Stockholders' Equity: | ||
Preferred stock (par value $0.001 per share; 10,000,000 shares authorized; 0 shares issued and outstanding as of June 30, 2018 and December 31, 2017, respectively) | 0 | 0 |
Common stock (par value $0.01 per share; 100,000,000 shares authorized; 74,224,373 and 73,612,052 shares issued and outstanding as of June 30, 2018 and December 31, 2017, respectively) | 742 | 736 |
Additional paid in capital | 286,556 | 278,356 |
Unrealized loss on available-for-sale securities, net of tax | (438) | (438) |
Notes receivable from stockholders | (21) | |
Accumulated deficit | (262,223) | (215,351) |
Total stockholders' equity | 24,637 | 63,282 |
Total liabilities and stockholders' equity | $ 235,145 | $ 279,080 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - USD ($) $ in Thousands | Jun. 30, 2018 | Dec. 31, 2017 |
Statement Of Financial Position [Abstract] | ||
Accounts receivable, allowance for doubtful accounts | $ 2,626 | $ 3,832 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 100,000,000 | 100,000,000 |
Common stock, shares issued (in shares) | 74,224,373 | 73,612,052 |
Common stock, shares outstanding (in shares) | 74,224,373 | 73,612,052 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Income Statement [Abstract] | ||||
Net revenue | $ 23,466 | $ 42,576 | $ 47,377 | $ 78,538 |
Cost of revenue | 3,596 | 3,921 | 5,800 | 8,560 |
Gross profit | 19,870 | 38,655 | 41,577 | 69,978 |
Operating expenses: | ||||
Sales and marketing | 9,079 | 13,292 | 18,130 | 28,950 |
Research and development | 16,473 | 14,103 | 28,733 | 27,037 |
General and administrative | 10,875 | 10,643 | 20,427 | 20,573 |
Legal | 11,148 | 6,483 | 21,485 | 11,595 |
Charges related to litigation award and settlements | 4,450 | 740 | 4,450 | |
Total operating expenses | 47,575 | 48,971 | 89,515 | 92,605 |
Operating loss | (27,705) | (10,316) | (47,938) | (22,627) |
Other income: | ||||
Interest income | 484 | 465 | 987 | 900 |
Other income (expense), net | (3) | 13 | (472) | 39 |
Total other income | 481 | 478 | 515 | 939 |
Loss before income taxes | (27,224) | (9,838) | (47,423) | (21,688) |
Income tax expense (benefit) | 126 | (1,654) | 297 | (6,980) |
Net loss | (27,350) | (8,184) | (47,720) | (14,708) |
Unrealized gain (loss) on available-for-sale securities, net of tax | 112 | (24) | 51 | |
Total comprehensive loss | $ (27,238) | $ (8,208) | $ (47,720) | $ (14,657) |
Net loss per common share: | ||||
Basic | $ (0.37) | $ (0.11) | $ (0.65) | $ (0.20) |
Diluted | $ (0.37) | $ (0.11) | $ (0.65) | $ (0.20) |
Weighted average common shares outstanding | ||||
Basic | 73,920,645 | 72,169,361 | 73,832,924 | 72,057,552 |
Diluted | 73,920,645 | 72,169,361 | 73,832,924 | 72,057,552 |
Condensed Consolidated Stateme5
Condensed Consolidated Statement of Stockholders' Equity - 6 months ended Jun. 30, 2018 - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid in Capital [Member] | Unrealized Loss on Available-For-Sale Securities [Member] | Notes Receivable From Stockholders [Member] | Accumulated Deficit [Member] |
Balance at Dec. 31, 2017 | $ 63,282 | $ 736 | $ 278,356 | $ (438) | $ (21) | $ (215,351) |
Balance (in shares) at Dec. 31, 2017 | 73,612,052 | |||||
Adoption of new accounting standard ASC 606 | 848 | 848 | ||||
Exercise of stock options | $ 916 | $ 4 | 912 | |||
Exercise of stock options (in shares) | 409,129 | 409,129 | ||||
Issuance of common stock- employee stock purchase plan | $ 736 | $ 2 | 734 | |||
Issuance of common stock- employee stock purchase plan (in shares) | 149,282 | |||||
Stock-based compensation- stock options, awards, and restricted stock units | 6,554 | 6,554 | ||||
Vesting of restricted stock units (in shares) | 53,910 | |||||
Write-off of notes receivable from stockholders | 21 | $ 21 | ||||
Net loss | (47,720) | (47,720) | ||||
Balance at Jun. 30, 2018 | $ 24,637 | $ 742 | $ 286,556 | $ (438) | $ (262,223) | |
Balance (in shares) at Jun. 30, 2018 | 74,224,373 |
Condensed Consolidated Stateme6
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2018 | Jun. 30, 2017 | |
Cash flows from operating activities: | ||
Net loss | $ (47,720) | $ (14,708) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Inventory obsolescence reserve | 1,005 | 2,959 |
Depreciation and amortization | 3,751 | 3,688 |
Stock-based compensation | 6,554 | 8,280 |
Deferred income tax benefit | (3,308) | |
Loss on disposal of property and equipment | 108 | 0 |
Impairment on property and equipment | 1,487 | |
Write-off of notes receivable and other assets due from stockholders | 26 | |
Amortization of investment discount | 114 | 676 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 1,446 | (3,318) |
Inventories | 930 | 345 |
Prepaid expenses and other current assets | (2,087) | (5,921) |
Accounts payable, accrued expenses and other current and noncurrent liabilities | (5,275) | (16,990) |
Accrued litigation award and settlements | (400) | 1,050 |
Net cash used in operating activities | (40,061) | (27,247) |
Cash flows from investing activities: | ||
Purchase of investments | (35,889) | (72,060) |
Proceeds from sales of investments | 11,855 | 2,919 |
Proceeds from maturities of investments | 48,424 | 47,422 |
Purchases of property and equipment | (1,890) | (9,013) |
Net cash provided by (used in) investing activities | 22,500 | (30,732) |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock | 736 | 836 |
Proceeds from exercise of stock options | 916 | 2,331 |
Net cash provided by financing activities | 1,652 | 3,167 |
Change in cash and cash equivalents | (15,909) | (54,812) |
Cash and cash equivalents, beginning of period | 31,999 | 104,642 |
Cash and cash equivalents, end of period | 16,090 | 49,830 |
Supplemental cash flow disclosures: | ||
Cash paid (refunded) for income taxes, net | (7) | 1,793 |
Non-cash capital expenditures | $ 1,174 | $ 642 |
Note 1 - Nature of Business and
Note 1 - Nature of Business and Basis of Presentation | 6 Months Ended |
Jun. 30, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Nature of Business and Basis of Presentation | 1. Nature of Business and Basis of Presentation Insys Therapeutics, Inc., which was incorporated in Delaware in June 1990, and our subsidiaries (collectively, “we,” “us,” and “our”) maintain headquarters in Chandler, Arizona. We are a commercial-stage specialty pharmaceutical company that develops and commercializes innovative supportive care products. As of June 30, 2018, we have two marketed products: SUBSYS®, a proprietary sublingual fentanyl spray for BTCP in opioid-tolerant adult patients; and SYNDROS®, a proprietary, orally administered liquid formulation of dronabinol for the treatment of CINV and anorexia associated with weight loss in patients with AIDS. The accompanying condensed consolidated financial statements are unaudited and have been prepared in accordance with U.S. GAAP, pursuant to rules and regulations of the SEC. Certain information and footnote disclosures have been condensed or omitted pursuant to such rules and regulations. In the opinion of management, the accompanying condensed consolidated financial statements include normal recurring adjustments that are necessary for a fair presentation of the results for the interim periods presented. These condensed consolidated financial statements should be read in conjunction with our audited consolidated financial statements and notes thereto for the fiscal year ended December 31, 2017, included in our Annual Report on Form 10-K. The results of operations for the three and six months ended June 30, 2018 and 2017, are not necessarily indicative of results to be expected for the full fiscal year or any other periods. The preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires management to make a number of estimates and judgments that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expense during the reported period. On an ongoing basis, we evaluate our estimates, including those related to revenue recognition (which are affected by prescriptions dispensed, wholesaler discounts, patient discount programs, rebates, returns, and chargebacks), inventories, fair value of investments, legal liabilities and settlements, stock-based compensation expense, impairment, uncertain tax positions, and deferred tax valuation allowances. We base our estimates on historical experience and on various other assumptions that are believed by management to be reasonable under the circumstances. Actual results could materially differ from these estimates. Certain prior period amounts have been reclassified to conform with current period presentation. All significant intercompany balances and transactions have been eliminated in the accompanying unaudited condensed consolidated financial statements. Recently Adopted Accounting Pronouncements Effective January 1, 2018, we adopted the requirements of ASU No. 2014-09, “Revenue from Contracts with Customers (ASC Topic 606),” and all the related amendments (“new revenue standard”). The new revenue standard aims to achieve a consistent application of revenue recognition within the United States, resulting in a single revenue model to be applied by reporting companies under U.S. GAAP. Under the new model, recognition of revenue occurs when a customer obtains control of promised goods or services in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. In addition, the new revenue standard requires that reporting companies disclose the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers. We used the modified retrospective transition method for all contracts that were not completed as of the adoption date. In addition, we have applied the practical expedient to contract modifications, as allowed by the SEC, but did not have any material contract modifications to be included in the initial adoption of ASC Topic 606. The comparative information in these condensed consolidated financial statements has not been restated and continues to be reported under ASC Topic 605, “Revenue Recognition.” We expect the impact of the adoption of the new standard to be immaterial to our net income (loss) on an ongoing basis. We recognize revenue when we transfer control of our products to our customers, as our contracts have a single performance obligation (delivery of our product to their preferred location). Our sales revenue from SUBSYS® continues to be recognized when product is delivered to wholesale pharmaceutical distributors and specialty retail pharmacies (collectively, our customers). In accordance with the new revenue standard, our sales revenue from SYNDROS® is now recognized when product is delivered to our customers, where revenue was previously deferred until the right of return no longer existed, which occurred at the earlier of the time SYNDROS® units were sold to health care facilities or dispensed through patient prescriptions, or the expiration of the right of return. It is common for our contracts to include product sales allowances that can decrease the transaction price and are therefore considered to be variable consideration. In accordance with the new revenue standard, we estimate the amount of variable consideration promised in the contract using the expected value (probability weighted estimate) method. We do not have any significant extended payment terms as payment is received shortly after the point of sale. See Note 2, Revenue Recognition The cumulative effect of the changes made to our January 1, 2018 condensed consolidated balance sheets for the adoption of the new revenue standard was as follows (in thousands): Balance at December 31, 2017 Adjustments due to adoption of ASC Topic 606 Balance at January 1, 2018 Condensed Consolidated Balance Sheets: Inventories, net 17,408 (59 ) 17,349 Accrued sales allowances 16,290 320 16,610 Deferred revenue 1,109 (1,109 ) — Accumulated deficit (215,351 ) 848 (214,503 ) The impact of adopting the new revenue standard on our condensed consolidated statements of operations and comprehensive loss Three Months Ended Six Months Ended June 30, 2018 June 30, 2018 Balances without Adopting ASC Topic 606 Impact of Adopting ASC Topic 606 As Reported Balances without Adopting ASC Topic 606 Impact of Adopting ASC Topic 606 As Reported Condensed Consolidated Statements of Operations and Comprehensive Loss: Net revenue $ 23,432 $ 34 $ 23,466 $ 47,178 199 $ 47,377 Cost of revenue 3,592 4 3,596 5,786 14 5,800 Gross profit 19,840 30 19,870 41,392 185 41,577 Operating loss (27,735 ) 30 (27,705 ) (48,123 ) 185 (47,938 ) Loss before income taxes (27,254 ) 30 (27,224 ) (47,608 ) 185 (47,423 ) Net loss (27,380 ) 30 (27,350 ) (47,905 ) 185 (47,720 ) The impact of adopting the new revenue standard on our condensed consolidated balance sheets was as follows (in thousands): June 30, 2018 Balances without Adopting ASC Topic 606 Impact of Adopting ASC Topic 606 As Reported Condensed Consolidated Balance Sheets: Inventories, net $ 9,928 73 $ 10,001 Total current assets 156,041 73 156,114 Total assets 235,072 73 235,145 Accrued sales allowances 12,353 229 12,582 Deferred revenue 1,537 (1,537 ) — Total liabilities 211,816 (1,308 ) 210,508 Accumulated deficit (262,408 ) 185 (262,223 ) Total stockholders' equity 24,452 185 24,637 Effective January 1, 2018, we adopted ASU No. 2016-01, “Financial Instruments—Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities,” and ASU No. 2018-03, “Technical Corrections and Improvements to Financial Instruments—Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities.” These standards amended the Financial Instruments topic of the ASC to address certain aspects of recognition, measurement, presentation, and disclosure of financial instruments. The standard requires that unrealized gains and losses on investments in equity securities to be recognized in net income (loss). The adoption of this guidance did not have a material impact on our condensed consolidated financial statements. Effective January 1, 2018, we adopted ASU No. 2016-15, “Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments.” The guidance clarifies how certain cash flow transactions are classified in the statement of cash flows. The adoption of this guidance did not have a material impact on our condensed consolidated financial statements. Effective January 1, 2018, we adopted ASU No. 2016-16, “Income Taxes (Topic 740): Intra-Entity Transfers of Assets Other Than Inventory.” Prior to January 1, 2018, U. S. GAAP prohibited the recognition of current and deferred income taxes for an intra-entity asset transfer until the asset was sold to an outside party, which was an exception to the principle of comprehensive recognition of current and deferred income taxes in U. S. GAAP. This guidance eliminates the exception for an intra-entity transfer of an asset other than inventory. The adoption of this guidance did not have a material impact on our condensed consolidated financial statements. Effective January 1, 2018, we adopted ASU No. 2017-09, “Compensation—Stock Compensation (Topic 718): Scope of Modification Accounting.” The ASU requires modification accounting to a share-based payment award unless all of the following are the same immediately before and after the change: the award’s fair value; the award’s vesting conditions; and the award’s classification as an equity instrument or a liability instrument. The adoption of this guidance did not have a material impact on our condensed consolidated financial statements. Effective January 1, 2018, we adopted ASU No. 2018-05, “Income Taxes (Topic 740): Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 118 (SEC Update).” The standard addresses any uncertainty or diversity of views in practice regarding the application of ASC Topic 740 in situations where a registrant did not have the necessary information available, prepared, or analyzed (including computations) in reasonable detail to complete the accounting under ASC Topic 740 for certain income tax effects of the 2017 Tax Cuts and Jobs Act (the “Act”) for the reporting period in which the Act was enacted. The Company recognized the provisional tax impacts of the Act in the fourth quarter of 2017. During the first quarter of 2018, the Company did not identify any additional information regarding these provisional calculations. As a result, the Company continues to anticipate finalizing its analysis in connection with the completion of the Company's tax return for 2017 to be filed in 2018. In June 2018, the FASB issued ASU No. 2018-07, “Compensation—Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting.” The standard expands the scope of ASC Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees, and supersedes ASC Topic 505-50, “Equity – Equity Based Payments to Non-Employees.” Previously, the fair value of share-based payment awards to nonemployees was determined by the measurement date, which was the earlier of the date at which a commitment for performance by the counterparty is reached or the date at which the counterparty’s performance is complete. This concept caused significant differences in the accounting for share-based payment to nonemployees as compared to share-based payments to employees. Furthermore, the previous guidance required employers to revalue share-based payments to nonemployees at each reporting period if a measurement date could not be established, causing fluctuations in the resulting expense from period to period. The new standard eliminates the measurement date concept and requires the fair value of share-based payments to nonemployees to be measured on the grant date, consistent with share-based payments to employees. We early adopted the standard during the three months ended June 30, 2018. We remeasured the fair value of our equity-classified share-based payments to nonemployees for which a measurement date had not been established as of the adoption date of January 1, 2018. Because we had previously remeasured our share-based payments to nonemployees at each reporting period, the adoption did not result in a cumulative effect adjustment to opening retained earnings. The impact of this adoption on the condensed consolidated financial statements for the three months ended March 31, 2018 was an increase to stock-based compensation reported in general and administrative expenses of approximately $259,000, with an offset to additional paid-in capital. Recent Accounting Pronouncements In March 2017, the FASB issued ASU No. 2017-08, “Receivables—Nonrefundable Fees and Other Costs (Subtopic 310-20): Premium Amortization on Purchased Callable Debt Securities,” to amend the amortization period for certain purchased callable debt securities held at a premium. The ASU shortens the amortization period for the premium to the earliest call date. Under current U.S. GAAP, entities generally amortize the premium as an adjustment of yield over the contractual life of the instrument. The amendments should be applied on a modified retrospective basis and are effective for fiscal years beginning after December 15, 2018. Early adoption is permitted, including adoption in an interim period. We are currently evaluating the impact of this amendment on our condensed consolidated financial statements. In June 2016, the FASB issued ASU No. 2016-13, “Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments.” The amendments effected by this ASU affect entities holding financial assets and net investment in leases that are not accounted for at fair value through net income and are effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years, and early adoption is permitted. ASU 2016-13 amends the impairment model to utilize an expected loss methodology in place of the currently used incurred loss methodology, which will result in the timelier recognition of losses. We do not expect this amendment to have a material impact on our condensed consolidated financial statements. In February 2016, the FASB issued ASU No. 2016-02, “Leases: (Topic 842),” to provide guidance on recognizing lease assets and lease liabilities on the balance sheet and disclosing key information about leasing arrangements, specifically differentiating between different types of leases. The core principle of Topic 842 is that a lessee should recognize the assets and liabilities that arise from all leases. The recognition, measurement, and presentation of expenses and cash flows arising from a lease by a lessee have not significantly changed from previous U.S. GAAP guidance. There continues to be a differentiation between finance leases and operating leases. However, the principal difference from previous guidance is that the lease assets and lease liabilities arising from operating leases should be recognized in the balance sheet. The accounting applied by a lessor is largely unchanged from that applied under previous U.S. GAAP guidance. The amendments will be effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years, and early adoption is permitted. In transition, lessees and lessors are required to recognize and measure leases at the beginning of the earliest period presented using a modified retrospective approach. The modified retrospective approach includes a number of optional practical expedients that entities may elect to apply. These practical expedients relate to the identification and classification of leases that commenced before the effective date, initial direct costs for leases that commenced before the effective date, and the ability to use hindsight in evaluating lessee options to extend or terminate a lease or to purchase the underlying asset. An entity that elects to apply the practical expedients will, in effect, continue to account for leases that commenced before the effective date in accordance with previous U.S. GAAP guidance unless the lease is modified, except that lessees are required to recognize a right-of-use asset and a lease liability for all operating leases at each reporting date based on the present value of the remaining minimum rental payments that were tracked and disclosed under previous U.S. GAAP guidance. We currently expect that most of our operating lease commitments will be subject to the update and recognized as right-of-use assets and operating lease liabilities upon adoption. We expect the standard to have a material impact on our assets and liabilities for the addition of right-of-use assets and lease liabilities, but we do not expect it to have a material impact to our results of operations or liquidity. |
Note 2 - Revenue Recognition
Note 2 - Revenue Recognition | 6 Months Ended |
Jun. 30, 2018 | |
Revenue Recognition [Abstract] | |
Revenue Recognition | 2. Revenue Recognition To determine revenue recognition for contractual arrangements that we determine are within the scope of ASC Topic 606, we perform the following five steps: (i) identify each contract with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to our performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy the relevant performance obligation. We only apply the five-step model to contracts when it is probable that we will collect the consideration we are entitled to in exchange for the goods we transfer to the customer. We recognize revenue from the sale of our commercially approved products, SUBSYS® and SYNDROS®, when we transfer control of our products to our customers, as our contracts have a single performance obligation (delivery of our product to their preferred location) . Revenue is measured as the amount of consideration we expect to receive in exchange for transferring goods. Any shipping and handling activities that we perform, whether before or after a customer has obtained control of the products, are considered activities to fulfill our obligation to transfer the products, and are recorded as incurred within sales and marketing expenses. SUBSYS® was commercially launched in March 2012 and is monitored by an FDA-mandated REMS program known as the TIRF REMS. SYNDROS® was commercially launched in July 2017. We sell all of our products in the United States to wholesale pharmaceutical distributors and directly to specialty retail pharmacies (collectively, our customers). See Note 10, Product Lines, Concentration of Credit Risk and Significant Customers, As is customary in the pharmaceutical industry, it is common for our contracts to include product sales allowances that can decrease the transaction price and are therefore considered to be variable consideration. Product sales allowances are based on amounts owed or to be claimed on the related sales. We estimate variable consideration when determining the transaction price using the expected value method. We assess whether variable consideration is constrained and only include estimated amounts in the transaction price to the extent it is probable that a significant reversal of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is resolved. Our estimates of variable consideration and determination of whether to include estimated amounts in the transaction price are based largely on historical data, and take into consideration the terms of our agreements with customers and third-party payers and the levels of inventory within the distribution channels that may result in future discounts taken. In certain cases, such as patient assistance programs, our estimates are based on estimated utilization. If actual future results vary, we may need to adjust these estimates, which could have an effect on revenue in the period of adjustment. Our product sales allowances include: Product Returns. We allow customers to return product for credit beginning six months prior to, and ending 12 months following, the product expiration date. SUBSYS® currently has a shelf life of 36 or 48 months from the date of manufacture, depending on the manufacture date, and SYNDROS® currently has a shelf life of 24 or 36 months from the date of manufacture, depending on the manufacture date. We have monitored actual return history since product launch, which provides us with a basis to reasonably estimate future product returns, taking into consideration the shelf life of product at the time of shipment, shipment and prescription trends, estimated distribution channel inventory levels and consideration of the introduction of competitive products. Because of the shelf life of our products and our return policy of issuing credits on returned product that is within six months before, and up to 12 months following, the product expiration date, there may be a significant period of time between when the product is shipped and when we issue credits on returned products. Accordingly, we may have to adjust these estimates, which could have an effect on net revenue and earnings in the period of adjustment. The allowance for product returns is included in accrued sales allowances. Wholesaler and Retailer Discounts. We offer discounts to certain wholesale distributors and specialty retailers based on contractually determined rates. We accrue the discount as a reduction of receivables due from the wholesalers and retailers upon shipment to the respective wholesale distributors and retail pharmacies. Prompt Pay Discounts . We offer cash discounts to our customers, generally 2% of the sales price, as an incentive for prompt payment. We account for cash discounts by reducing accounts receivable by the full amount of the discount. Stocking Allowances . We may offer discounts and extended payment terms, generally in the month of the initial commercial launch of a new product and on the first order made by certain wholesale distributors and retail pharmacies based on contractually determined rates. We accrue the discount as a reduction of receivables due from the wholesalers and retailers upon shipment to the respective wholesale distributors and retail pharmacies. The extended payment terms are not greater than 12 months and therefore do not include a financing component. Patient Discount Programs . We offer discount card programs to patients, in which patients receive discounts on their prescriptions that are reimbursed by us to the retailer. We estimate the total amount that will be redeemed based on a percentage of actual redemptions applied to inventory in the distribution and retail channels. The allowance for patient discount programs is included in accrued sales allowances. Rebates . We participate in certain rebate programs, which provide discounted prescriptions to qualified insured patients. Under these rebate programs, we pay a rebate to the third-party administrator of the program, generally two to three months after the quarter in which prescriptions subject to the rebate are filled. We estimate and accrue these rebates based on current and estimated future contract prices, historical and estimated future percentages of products prescribed to qualified patients and estimated levels of inventory in the distribution channel. The allowance for rebates is included in accrued sales allowances. Chargebacks. We provide discounts primarily to authorized users of the FSS of the General Services Administration under an FSS contract negotiated by the Department of Veterans Affairs and various organizations under Medicaid contracts and regulations. These organizations purchase products from the wholesale distributors at a discounted price, and the wholesale distributors then charge back to us the difference between the current retail price and the price the organization paid for the product. We estimate and accrue chargebacks based on estimated wholesaler inventory levels, current contract and estimated future prices and historical chargeback activity. Estimated chargebacks are recognized as a reduction of revenue in the same period the related revenue is recognized. The allowance for chargebacks is included as a reduction to accounts receivable. As of June 30, 2018, the majority of our accounts receivables were related to product sales. For the three and six months ended June 30, 2018, the Company had no material bad-debt expense and there were no contract assets, contract liabilities or deferred contract costs |
Note 3 - Short-term and Long-te
Note 3 - Short-term and Long-term Investments | 6 Months Ended |
Jun. 30, 2018 | |
Schedule Of Investments [Abstract] | |
Short-Term and Long-Term Investments | 3. Short-Term and Long-Term Investments Our policy for short-term and long-term investments is to establish a high-quality portfolio that preserves principal, meets liquidity needs, avoids inappropriate concentrations, and delivers an appropriate yield in relationship to our investment guidelines and market conditions. Short-term and long-term investments consist of corporate and various government agency and municipal debt securities, commercial paper, as well as certificates of deposit that have maturity dates that are greater than 90 days. Certificates of deposit and commercial paper are carried at cost, which approximates fair value. We classify our marketable securities as available-for-sale in accordance with FASB ASC Topic 320, “Investments — Debt and Equity Securities.” Investments in debt securities that are classified as available-for-sale are carried at fair value with unrealized gains and losses reported in stockholders’ equity, net of related tax effects. There were no reclassifications on available-for-sale securities during the three and six months ended June 30, 2018 and 2017. A decline in the market value of any available-for-sale security below cost that is deemed to be other than temporary results in impairment of the fair value of the investment. If we had unrealized gains and losses and declines in value judged to be other than temporary, we would have been required to include those changes in other income (expense) in the condensed consolidated statements of operations and comprehensive loss. Premiums and discounts are amortized or accreted over the life of the related available-for-sale security. The cost of securities sold is calculated using the specific identification method. At June 30, 2018, our certificates of deposit and commercial paper as well as our marketable securities have been recorded at an estimated fair value of $599,000, $88,813,000, and $18,605,000 in cash and cash equivalents, short-term and long-term investments, respectively. Investments consisted of the following at June 30, 2018 (in thousands): Cost Unrealized Gains Unrealized Losses Other- Than- Temporary Impairment Losses Fair Value Cash and Cash Equivalents Short-term Investments Long-term Investments Cash and cash equivalents $ 6,425 $ — $ — $ — $ 6,425 $ 6,425 $ — $ — Money market securities 9,066 — — — 9,066 9,066 — — Marketable securities: Certificates of deposit 14,528 — — — 14,528 — 7,827 6,701 Commercial paper 15,228 — — — 15,228 599 14,629 — Corporate securities 44,159 — (222 ) — 43,937 — 41,488 2,449 Federal agency securities 29,877 — (205 ) — 29,672 — 20,568 9,104 Municipal securities 4,663 — (11 ) — 4,652 — 4,301 351 Total marketable securities 108,455 — (438 ) — 108,017 599 88,813 18,605 $ 123,946 $ — $ (438 ) $ — $ 123,508 $ 16,090 $ 88,813 $ 18,605 Investments consisted of the following at December 31, 2017 (in thousands): Cost Unrealized Gains Unrealized Losses Other- Than- Temporary Impairment Losses Fair Value Cash and Cash Equivalents Short-term Investments Long-term Investments Cash and cash equivalents $ 12,183 $ — $ — $ — $ 12,183 $ 12,183 $ — $ — Money market securities 15,317 — — — 15,317 15,317 — — Marketable securities: Certificates of deposit 18,447 — — — 18,447 — 7,474 10,973 Commercial paper 10,560 — — — 10,560 1,499 9,061 — Corporate securities 59,613 — (206 ) — 59,407 1,500 39,622 18,285 Federal agency securities 37,793 — (203 ) — 37,590 1,500 20,015 16,075 Municipal securities 10,446 — (29 ) — 10,417 — 9,017 1,400 Total marketable securities 136,859 — (438 ) — 136,421 4,499 85,189 46,733 $ 164,359 $ — $ (438 ) $ — $ 163,921 $ 31,999 $ 85,189 $ 46,733 The amortized cost and estimated fair value of the marketable securities by maturity, are shown below (in thousands): June 30, 2018 December 31, 2017 Amortized Cost Fair Value Amortized Cost Fair Value Marketable securities: Due in one year or less $ 89,618 $ 89,362 $ 90,071 $ 89,937 Due after one year through 5 years 18,537 18,355 46,788 46,484 Due after 5 years through 10 years — — — — Due after 10 years 300 300 — — $ 108,455 $ 108,017 $ 136,859 $ 136,421 The following table shows the gross unrealized losses and the fair value of our investments, with unrealized losses that are not deemed to be other-than-temporarily impaired aggregated by investment category and length of time that individual securities have been in a continuous unrealized loss position (in thousands): June 30, 2018 December 31, 2017 Less Than 12 Months Greater Than 12 Months Less Than 12 Months Greater Than 12 Months Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss Marketable securities: Corporate securities $ 28,904 $ (135 ) $ 14,023 $ (87 ) $ 245 $ (153 ) $ 7,839 $ (52 ) Federal agency securities 17,362 (113 ) 11,911 (92 ) 26,244 (89 ) 11,346 (114 ) Municipal securities 2,358 (5 ) 1,030 (6 ) 50,537 (18 ) 1,145 (12 ) $ 48,624 $ (253 ) $ 26,964 $ (185 ) $ 77,026 $ (260 ) $ 20,330 $ (178 ) We did not have any unrealized gains or losses or decline in values judged to be other than temporary during the three and six months ended June 30, 2018 and 2017. This review includes an analysis of the facts and circumstances of each individual investment such as the severity of loss, the expectation for that security’s performance and the creditworthiness of the issuer. |
Note 4 - Fair Value Measurement
Note 4 - Fair Value Measurement | 6 Months Ended |
Jun. 30, 2018 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurement | 4. Fair Value Measurement FASB ASC Topic 820, Fair Value Measurement, defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. It also establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows: Level 1: Observable inputs such as quoted prices in active markets; Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions. At June 30, 2018 and December 31, 2017, we held short-term and long-term investments, as discussed in Note 3, that are required to be measured at fair value on a recurring basis. Except as discussed in Note 6, we had no assets or liabilities measured at fair value on a nonrecurring basis at June 30, 2018 and December 31, 2017. Substantially all available-for-sale investments held by us at June 30, 2018 and December 31, 2017, have been valued based on Level 2 inputs. Available-for-sale securities classified within Level 2 of the fair value hierarchy are valued utilizing reports from an independent third-party public quotation service based on closing prices on the last business day of the period presented. In addition, we use the public quotation service to perform price testing by comparing quoted prices listed in reports provided by the asset managers that hold our investments to quotes listed through the public quotation service. These asset managers utilize an independent pricing source to obtain quotes for most fixed income securities and utilize internal procedures to validate the prices obtained. Our Level 3 asset represents an investment in convertible preferred stock that is not listed on any security exchange. The fair value of the preferred stock approximates its carrying value at June 30, 2018 and December 31, 2017. Our assets and liabilities subject to the disclosure requirements of ASC Topic 820 at June 30, 2018, were as follows (in thousands): Fair Value Measurement at Reporting Date Total Quoted Prices in active Markets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Gains (Losses) Recurring fair value measurements Marketable securities: Certificates of deposit $ 14,528 $ — $ 14,528 $ — Commercial paper 15,228 — 15,228 — Corporate securities 43,937 — 43,419 518 Federal agency securities 29,672 — 29,672 — Municipal securities 4,652 — 4,652 — Total recurring fair value measurements $ 108,017 $ — $ 107,499 $ 518 Nonrecurring fair value measurements Property and equipment (see Note 6) — — — — $ (1,487 ) Total nonrecurring fair value measurements $ — $ — $ — $ — $ (1,487 ) Our assets and liabilities subject to the disclosure requirements of ASC Topic 820 at December 31, 2017, were as follows (in thousands): Fair Value Measurement at Reporting Date Total Quoted Prices in active Markets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Recurring fair value measurements Marketable securities: Certificates of deposit $ 18,447 $ — $ 18,447 $ — Commercial paper 10,560 — 10,560 — Corporate securities 59,407 — 58,889 518 Federal agency securities 37,590 — 37,590 — Municipal securities 10,417 — 10,417 — Total recurring fair value measurements $ 136,421 $ — $ 135,903 $ 518 The following table presents additional information about assets measured at fair value on a recurring basis and for which we utilize Level 3 inputs to determine fair value for the three and six months ended June 30, 2018 and 2017 (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2018 2017 2018 2017 Convertible preferred stock Balance, beginning of period $ 518 $ 518 $ 518 $ 500 Change in fair value — — — 18 Balance, end of period $ 518 $ 518 $ 518 $ 518 |
Note 5 - Inventories, Net
Note 5 - Inventories, Net | 6 Months Ended |
Jun. 30, 2018 | |
Inventory Disclosure [Abstract] | |
Inventories, Net | 5. Inventories, net Inventories are stated at lower of cost or NRV. Cost, which includes amounts related to materials and costs incurred by our contract manufacturers, is determined on a first-in, first-out basis. Inventories are reviewed periodically for potential excess, dated or obsolete status. Management evaluates the carrying value of inventories on a regular basis, taking into account such factors as historical and anticipated future sales compared to quantities on hand, the price we expect to obtain for products in their respective markets compared with historical cost and the remaining shelf life of goods on hand. The components of inventories, net of allowances, are as follows (in thousands): June 30, December 31, 2018 2017 Finished goods $ 2,521 $ 4,709 Work-in-process 4,302 5,752 Raw materials and supplies 3,178 6,947 Total inventories 10,001 17,408 Plus: non-current raw materials and finished goods 6,358 826 $ 16,359 $ 18,234 As of June 30, 2018 and December 31, 2017, raw materials inventories consisted of raw materials used in the manufacture of the dronabinol API for SYNDROS® in our U.S.-based, state-of-the-art dronabinol manufacturing facility, the fentanyl API for SUBSYS®, and component parts and packaging materials used in the manufacture of both SUBSYS® and SYNDROS®. Work-in-process consisted of actual production costs, including facility overhead and tooling costs of in-process dronabinol, SUBSYS® and SYNDROS® products. Finished goods inventories consisted of finished SUBSYS® and SYNDROS® products and deferred SYNDROS® cost of revenue of $0 and $59,000 as of June 30, 2018 and December 31, 2017, respectively. There was no deferred SYNDROS® cost of revenue as of June 30, 2018, due to the adoption of ASC Topic 606 on January 1, 2018. Non-current raw materials and finished goods represent those inventories not expected to be consumed or sold within 12 months of the balance sheet date and are included in other assets in our condensed consolidated balance sheets. As of June 30, 2018 and December 31, 2017, all work-in-process inventory is expected to be used within 12 months of the balance sheet date and, therefore, is classified as current assets in our condensed consolidated balance sheets. We maintain an allowance for excess and obsolete inventory, as well as inventory where its cost is in excess of its NRV. Inventories at June 30, 2018 and December 31, 2017, were reported net of these reserves of $9,599,000 and $13,664,000, respectively. During the three and six months ended June 30, 2018, we decreased these reserves by approximately $5,068,000 for the destruction of previously reserved product, partially offset by an increase to the reserves of approximately $1,005,000 and $477,000, respectively. During the three and six months ended June 30, 2017, we increased these reserves by approximately $2,959,000 and $1,185,000, respectively. |
Note 6 - Property and Equipment
Note 6 - Property and Equipment, Net | 6 Months Ended |
Jun. 30, 2018 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment, Net | 6. Property and Equipment, Net Property and equipment are recorded at cost and depreciated using the straight-line method over their estimated useful lives; leasehold improvements are recorded at cost and depreciated using the straight-line method over the shorter of their estimated useful lives or remaining lease term. Maintenance and repairs that do not extend the life of assets are charged to expense when incurred. When property and equipment is disposed of, the related costs and accumulated depreciation are removed from the condensed consolidated balance sheets, and any gain or loss is reported in other income (expense) in the period the transaction takes place. During the three and six months ended June 30, 2018, we recorded losses on the disposal of property and equipment of $0 and $108,000, respectively. There were no such charges during the three and six months ended June 30, 2017. Property and equipment are reviewed for impairment whenever events or changes in circumstances indicate the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to estimated undiscounted cash flows expected to be generated by the asset. If the carrying amount exceeds its estimated future undiscounted cash flows, an impairment charge is recognized by the amount by which the carrying amount exceeds the fair value of the asset. The fair value is measured on a nonrecurring basis using unobservable (Level 3) inputs. Impairment charges are reported in the period the impairment is identified. During the three and six months ended June 30, 2018, we recorded impairment charges in research and development of $1,487,000, as the result of a decision to abandon a partially constructed device manufacturing machine with a cost of $1,487,000 and no associated depreciation. There were no such charges during the three and six months ended June 30, 2017. |
Note 7 - Commitments and Contin
Note 7 - Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 7. Commitments and Contingencies Legal Matters Other than the matters that we have disclosed below, we from time to time become involved in various ordinary course legal and administrative proceedings, which include intellectual property, commercial, governmental and regulatory investigations, employee-related issues and private litigation, which we do not currently believe are either individually or collectively material. We record accruals for contingencies when it is probable that a liability has been incurred and the amount can be reasonably estimated. These accruals are adjusted periodically as assessments change or additional information becomes available. If the reasonable estimate of a probable loss is a range, and no amount within the range is a better estimate, the minimum amount in the range is accrued. If a loss is not probable or a probable loss cannot be reasonably estimated, no liability is recorded. We have established reserves for certain of our legal matters. Our loss estimates are generally developed in consultation with outside counsel and outside accounting experts and are based on analyses of potential outcomes. As legal and governmental proceedings, disputes and investigations are inherently unpredictable and in part, beyond our control, unless otherwise indicated, we cannot reasonably predict the outcome of these legal proceedings, nor can we estimate the amount of loss, or range of loss, if any, that may result from these proceedings. While our liability in connection with certain claims cannot be currently estimated, the resolution in any reporting period of one or more of these matters could have a significant impact on our consolidated financial condition, results of operations, liquidity, and cash flows for that future period, and could ultimately have a material adverse effect on our consolidated financial position and could cause the market value of our common shares to decline. While we believe we have valid defenses in these matters, litigation and governmental and regulatory investigations are inherently uncertain, and we may in the future incur material judgments or enter into material settlements of claims. Government Proceedings Like other companies in the pharmaceutical industry, we are subject to extensive regulation by national, state and local government agencies in the United States. As a result, interaction with government agencies occurs in the normal course of our operations. The following is a brief description of pending governmental investigations that we believe are potentially or actually material at this time. It is possible that criminal charges and substantial payments, fines and/or civil penalties or damages or exclusion from federal health care programs or other administrative actions, as well as a corporate integrity agreement, deferred prosecution agreement, or similar government mandated compliance document that institutes significant restrictions or obligations, could result for us from any government investigation or proceeding. In addition, even certain investigations that are not discussed below and which we do not deem to be material at this time could be determined to be material and could have a material adverse effect on our financial condition, results of operations and cash flows. HHS Investigation . We received a subpoena, dated December 9, 2013, from the Office of Inspector General of the HHS in connection with an investigation of potential violations involving HHS programs. This subpoena was issued in connection with an investigation by the U.S. Attorney’s Office for the Central District of California and requested documents regarding our business, including the commercialization of SUBSYS®. We continue to cooperate with this investigation and have produced substantial documents in response to the subpoena and have provided other requested information. On April 13, 2018, the United States intervened in part and declined to intervene in part in five lawsuits: United States ex rel. Guzman v. Insys Therapeutics, Inc. United States ex rel Doe v. Insys Therapeutics, Inc. United States ex rel. Andersson v. Insys Therapeutics, Inc. United States ex rel. Erickson v. Insys Therapeutics, Inc. United States ex rel. Doe v. Insys Therapeutics, Inc. The States of California, Colorado, Indiana, Minnesota, New York, North Carolina, and Virginia (the “Plaintiff States”) elected to intervene in part and declined to intervene in part in United States ex rel. Guzman v. Insys Therapeutics, Inc. United States ex rel. Doe v. Insys Therapeutics, Inc. The United States’ Complaint in Intervention, which was ordered unsealed on May 11, 2018, brings claims for False Claims Act: Presentation of False Claims pursuant to 31 U.S.C. § 3729(a)(1)(A), False Claims Act: Using False Statements to Get False Claims Paid pursuant to 31 U.S.C. § 3729(a)(1)(B), Payment by Mistake, and Unjust Enrichment. This case is currently stayed and we continue to have ongoing discussion with respect to the DOJ Investigation (as discussed below). The qui tam HIPAA Investigation . On September 8, 2014, we received a subpoena issued pursuant to HIPAA from the U.S. Attorney’s Office for the District of Massachusetts. The subpoena requested documents regarding SUBSYS®, including our sales and marketing practices related to this product. This investigation also relates to activities in our patient services hub. We continue to cooperate with this investigation and have produced a substantial number of documents in response to the subpoena and have provided other requested information. DOJ Investigation and Agreement in Principle . We collectively refer to the HHS and HIPAA investigations discussed above as the “DOJ Investigation”. In connection with our cooperation, we have been engaged in discussions with the DOJ about these matters, including a resolution of potential liability exposure. Management accrued, as of September 30, 2017, an aggregate of $150,000,000, which represented our best estimate of the minimum liability exposure that we expected to be paid out over five years in connection with the DOJ Investigation. This estimate reflected a minimum exposure at which management had determined a willingness to settle these matters. The accrual was recorded in accrued litigation award and settlements on our condensed consolidated balance sheets and as an operating expense on our condensed consolidated statements of operations and comprehensive loss. On August 8, 2018, we announced that we reached an agreement in principle with the DOJ to settle the DOJ’s civil and criminal investigation into inappropriate sales and commercial practices by some former company employees. Our initial estimate of the minimum liability exposure we previously accrued in connection with the DOJ Investigation of $150,000,000 expected to be paid over five years remains unchanged as of June 30, 2018, with the potential for contingency-based payments associated with certain events that, if they were to occur, management estimates would require additional payments ranging from $0 to $75,000,000. This agreement in principle is subject to the negotiation of final settlement documents with the government. We expect that a final settlement would include other material non-financial terms and conditions which will also be subject to negotiation. Because other material, non-financial terms and conditions remain subject to the negotiation of final settlement documents, we cannot provide assurances as to the timing of the execution of final documentation and, like any pending negotiation, there is uncertainty as to the outcome. Moreover, any such final settlement is likely to involve entry into final agreements, which will impose significant costs and burdens and obligations on our business operations and could materially and adversely affect our results of operations and financial conditions as we implement and adhere to such requirements. At this time, the aforementioned accrual does not currently meet the more likely than not standard for tax deductibility; therefore, we have recognized no tax benefit for it in the condensed consolidated financial statements. It is possible that some or all of this accrual may meet the more likely than not standard in the future, at which time the benefit would be recognized. SEC Investigation . On January 11, 2018, the SEC's Los Angeles Regional office requested that the Company voluntarily provide information on the Company's: (1) restatement of the Company’s interim unaudited condensed consolidated financial statements as of and for the quarters ended September 30, June 30, and March 31, 2016 and 2015, filed on April 7, 2017; (2) sales and marketing practices; and (3) compliance program, internal controls and enhancements thereto. The Company has provided such information and continues to cooperate with the SEC's investigation, including by responding to requests or demands for documents and other information. Health Care Professionals and Former Employees Related Investigations. Investigations of Health Care Professionals. A number of health care practitioners who formerly interacted with our company are under investigation or have been charged in criminal proceedings. In addition to the below investigations that are specifically directed at us, we have received governmental agency requests for information, including subpoenas, from at least the following governmental bodies: the USAO and/or HHS OIG of California (Los Angeles), Central District of California, Colorado, Connecticut, Eastern District of Michigan, Eastern District of New York, Florida (Jacksonville), Kansas, Middle District of Florida, Middle District of Pennsylvania, New Hampshire, New Jersey, Northern District of California, Northern District of Texas, Rhode Island, Southern District of Alabama, Southern District of New York, Southern District of Ohio, Western District of New York, and the states of Arizona, Delaware, Maryland and New York, regarding specific health care professionals with which we have interacted with in those states. In addition, at least the following health care practitioners formerly interacting with our company have been charged as follows: On or about June 23, 2015, a nurse practitioner located in Connecticut, who served on our speaker bureau in connection with our speaker programs designed to educate and promote product awareness and safety for external health care providers, pled guilty to violating the federal Anti-Kickback Statute in connection with payments of approximately $83,000 from us. On or about November 7, 2016, a health care professional located in Michigan who served on our speaker bureau pled guilty to healthcare fraud in connection, in part, with receiving payments from us. On February 23, 2017, two Alabama health care professionals who served on our speaker bureau were convicted on 19 of 20 counts brought against them, which included charges related to distribution of a controlled substance, drug conspiracy, health care fraud conspiracy and money laundering. On or about March 22, 2017, the U.S. Attorney’s Office for the District of New Hampshire filed an indictment against a physician assistant, who served on our speaker bureau, charging him with violating the federal Anti-Kickback Statute and conspiring to violate the federal Anti-Kickback Statute in connection with payments received for serving as an Insys promotional speaker. The physician assistant pled not guilty. On or about October 20, 2017, a health care professional in Rhode Island, who served on our speaker bureau pled guilty to health care fraud and conspiracy to receive kickbacks in connection with payments of approximately $188,000 from us. On or about March 14, 2018, the U.S. Attorney’s Office for the Southern District of New York filed an indictment against five health care professionals who served on our speaker bureau, charging them with conspiracy to violate the federal Anti-Kickback Statute, violation of the federal Anti-Kickback Statute, and conspiracy to commit honest services fraud, and charged certain of them with aggravated identity theft, false statements, and wrongful disclosure of individually identifiable health information. On or about June 4, 2018, a Florida health care professional who served on our speaker bureau pled guilty to conspiracy to receive healthcare kickbacks in connection, in part, with receiving payments from us. On or about June 28, 2018, an Ohio health care professional who served on our speaker bureau was indicted for violating the federal Anti-Kickback Statute in connection with receiving payments of more than $103,000 from us. Investigations of Former Employees. A number of our former employees have been charged in criminal proceedings related to our federal investigations and the following is certain information related thereto. On or about February 18, 2016, one of our former sales employees located in Alabama pled guilty to a conspiracy to violate the federal Anti-Kickback Statute in connection with two convicted Alabama health care professionals mentioned above. On or about April 23, 2018, the former sales employee was sentenced to six months home confinement. On or about June 19, 2016, a former district sales manager in New York and a former sales representative in New Jersey were charged in a federal court in Manhattan, New York, with violating the federal Anti-Kickback Statute in connection with interacting with health care professionals who prescribed our product and served on our speaker bureau. On June 1, 2017, the former district sales manager was charged in a superseding indictment with additional charges of honest services wire fraud and aggravated identity theft in connection with falsifying sign-in sheets for our speaker programs. On or about March 16, 2018, records were unsealed indicating that the two former employees each pled guilty to conspiracy to violate the Anti-Kickback Statue, violation of the Anti-Kickback Statue, violation of HIPAA, conspiracy to commit honest services wire fraud, and aggravated identity theft, and that the former sales representative also pled guilty to health care fraud. On or about December 8, 2016, the U.S. Attorney’s Office for the District of Massachusetts issued an indictment against six former employees, including Michael L. Babich, our former President, CEO and director, on charges including racketeering conspiracy, conspiracy to commit mail fraud, conspiracy to commit wire fraud, conspiracy to violate the Anti-Kickback Statute and forfeiture (the “Original Indictment”). On or about October 26, 2017, the U.S. Attorney’s Office for the District of Massachusetts issued a superseding indictment in connection with the Original Indictment and added charges against our former President, CEO and director, Dr. John N. Kapoor. After Dr. Kapoor’s indictment, he agreed to put his ownership in our common stock in a trust to be controlled independently, which was executed on February 27, 2018 and filed with the Securities and Exchange Commission on a Current Report on Form 8-K on March 1, 2018. On or about February 8, 2017, a former district sales manager in the Northeast was charged in federal court in New Haven, Connecticut, with violating the federal Anti-Kickback Statute in connection with interacting with health care professionals who prescribed our product and served on our speaker bureau. On April 5, 2017, the U.S. Attorney’s Office for the District of Massachusetts filed an information charging a former prior authorization specialist and manager of our patient services hub with one count of wire fraud conspiracy; the former employee pled guilty to that information on June 19, 2017. On or about July 11, 2017, a former district sales manager pled guilty to conspiring to violate the federal Anti-Kickback Statute related to her activities in the Southern District of Alabama, as well as the Middle and Southern Districts of Florida, including in connection with the two convicted Alabama health care professionals mentioned above. On or about May 30, 2018, a former specialty sales professional pled guilty to a second-degree charge of conspiracy to commit commercial bribery related to her activities in New Jersey. Except as otherwise indicated, we understand that each of these indicted individuals have entered pleas of not guilty to the charges against them. Given the ongoing investigations related to our company and our current and former employees, as well as other individuals associated with our company, including health care professionals, it is possible that additional individual or company criminal charges and convictions and pleas could result from our ongoing federal and state government investigations and related proceedings and the foregoing disclosure and the disclosure below is merely intended to provide general insight into the comprehensive nature of the scope and breadth of investigations that are being conducted related to our company and is not, nor is it intended to be, an exhaustive listing of every charge, conviction or pleading in connection with our company. We continue to assess these matters to ensure we have an effective compliance program. Ongoing State-Related Investigations . We have received CIDs or subpoenas, as the case may be, from at least each of the following state’s Office of the Attorney General (or similarly named and authorized office) which have ongoing investigations directed at our company: Arizona, Colorado, Florida, Kansas, Kentucky, Maryland, Minnesota, Missouri, New Jersey, New York, North Carolina, Pennsylvania, Rhode Island, Virginia and Washington. Moreover, we have received an administrative subpoena from the California Insurance Commissioner. In addition, we understand that numerous physicians practicing within several of the aforementioned states have received subpoenas from certain state Attorney General or Department of Justice offices in connection with interactions with us. Generally, these CIDs and subpoenas request documents regarding SUBSYS®, including our sales and marketing practices related to SUBSYS® in the applicable state, as well as our patient services hub. We are cooperating with each of these investigations and have produced, or anticipate producing, documents in response to these CIDs, subpoenas and related requests for information from each office. Resolved State-Related Investigations. Our company has resolved investigations conducted by certain states’ Office of the Attorney General (or similarly named and authorized office) as follows: In connection with the investigation by the ODOJ, we entered into a settlement agreement with the ODOJ, referred to as an AVC, and made monetary payments totaling approximately $1,100,000. The AVC requires us to maintain certain controls and processes around our promotional and sales activity related to SUBSYS® in Oregon. This AVC expressly provides that we do not admit any violation of law or regulation. This settlement was reached as a result of our cooperation with the ODOJ's investigation and after producing documents in response to certain CIDs and related requests for information from the ODOJ. All monetary payments in connection with this settlement were made prior to December 31, 2015. In connection with the investigation by the Illinois Office of the Attorney General, such office filed a complaint against us on behalf of the State of Illinois on August 25, 2016, in the Circuit Court of Cook County, Illinois, Chancery Division, asserting a claim for violation of the Illinois Consumer Fraud and Deceptive Business Practices Act in connection with the sales and marketing of SUBSYS®. On August 18, 2017, the Circuit Court of Cook County entered a Final Judgment and Consent Decree, which, among other things, provided for a monetary payment of $4,450,000 by Insys and requires us to maintain certain controls and processes around our promotional and sales activity related to SUBSYS® in Illinois. The Final Judgment and Consent Decree expressly provides that we do not admit any violation of law or regulation. All monetary payments in connection with this Final Judgment and Consent Decree were accrued in the consolidated balance sheets as of June 30, 2017 and the payments in connection with this settlement were made prior to September 30, 2017. In connection with the investigation by the State of New Hampshire, we entered into a settlement agreement with the State of New Hampshire referred to as an assurance of discontinuance, and made monetary payments totaling approximately $2,900,000 to the State of New Hampshire and a charitable contribution of $500,000 to be used by a New Hampshire charitable foundation in preventing or remediating problems related to abuse, misuse or misprescribing of opioid drugs. The assurance of discontinuance expressly provides that we do not admit any violation of law or regulation and requires us to maintain certain controls and processes around our promotional and sales activity related to SUBSYS® in New Hampshire. This settlement was reached as a result of our cooperation with the State of New Hampshire investigation and after producing documents in response to certain requests for information by the State of New Hampshire. These amounts were accrued in the consolidated balance sheets as of December 31, 2016 and the payments in connection with this settlement were made during the three months ended March 31, 2017. In connection with the investigation by the State of Massachusetts, we entered into a settlement with the State of Massachusetts, which was entered by the Superior Court of the Commonwealth of Massachusetts in a Final Judgment by Consent on October 5, 2017. The Final Judgment by Consent provided for a monetary payment of $500,000 and requires us to maintain certain controls and processes around our promotional and sales activity related to Massachusetts. The Final Judgment by Consent expressly provides that we do not admit any liability or wrongdoing. The amount of the monetary payment was accrued in the consolidated balance sheets as of September 30, 2017 and the payments in connection with this settlement were made during the three months ended December 31, 2017. Ongoing Complaints filed in connection with State AG Investigations . Our Company has several ongoing legal proceedings related to complaints filed in connection with investigations conducted by certain states’ Office of the Attorney General (or similarly named and authorized office) as follows: In connection with the investigation by the State of Arizona, on August 30, 2017, the Arizona Attorney General filed a complaint on behalf of the State of Arizona against us in the Maricopa County, Arizona Superior Court. The complaint asserts claims for violations of the Arizona Consumer Fraud Act in connection with the sales and marketing of SUBSYS® in Arizona and in connection with our patient services hub. The complaint seeks a permanent injunction preventing us from engaging in practices in violation of the Arizona Consumer Fraud Act, restitution to consumers and other persons, disgorgement of profits, civil penalties, and investigative costs. On or about November 10, 2017, we filed a motion to dismiss. On January 17, 2018, the Court dismissed, based upon preemption by the federal Sunshine Act, the State’s claim to the extent related to remedies that are based upon the payment and disclosure of speaker fees, but did not dismiss the rest of the complaint. The State filed a motion for leave to amend its complaint, which the Court granted. We filed our answer to the amended complaint on April 5, 2018. In connection with the investigation by the State of New Jersey, on October 5, 2017, the New Jersey Attorney General, on behalf of the State of New Jersey, and the Acting Director of the New Jersey Division of Consumer Affairs filed a complaint against us in the Superior Court of New Jersey, Chancery Division, Middlesex Vicinage. The complaint asserts claims for violations of the New Jersey Consumer Fraud Act and for violations of the New Jersey False Claims Act in connection with the sales and marketing of SUBSYS® in New Jersey and in connection with our patient services hub. The complaint seeks a permanent injunction preventing us from engaging in practices in violation of the New Jersey Consumer Fraud Act, disgorgement of profits, civil penalties, treble damages for alleged violations of the New Jersey False Claims Act, and costs and attorneys’ fees. On November 16, 2017, the New Jersey Attorney General filed an Amended Complaint, which we moved to dismiss on January 8, 2018. The New Jersey Attorney General opposed our motion on March 28, 2018, and we replied. The Court held oral argument on the motion on June 18, 2018. On December 21, 2017, Attorney General of the State of North Carolina filed a complaint in Wake County, North Carolina Superior Court against us. The complaint asserts claims related to alleged violations of the North Carolina Consumer Protection Act. Our response to this complaint is due on September 27, 2018. On February 1, 2018, the Attorney General of the State of New York, filed a complaint against us in the Supreme Court of the State of New York, County of New York. The complaint asserts claims related to alleged deceptive acts and practices. We moved to dismiss the complaint on April 18, 2018. In response, on May 25, 2018, the New York Attorney General opposed our motion to dismiss and filed a cross-motion for partial summary judgment related to the State’s commercial bribery claim. On June 29, 2018, we filed a reply in support of our motion to dismiss and opposed the State’s motion for partial summary judgment. Oral argument on the motions currently scheduled for August 23, 2018. On February 5, 2018, the Consumer Protection Division, Office of the Attorney General of Maryland, filed a petition to enforce an administrative subpoena against us. Our response to this petition was filed on April 2, 2018. On April 23, 2018, the Maryland Attorney General filed a motion to strike our response and for judgment on the pleadings, and on April 27, 2018, filed a renewed motion to strike and for judgment on the pleadings. On May 8, 2018, we filed a response to the Maryland Attorney General’s initial motion to strike our response and for judgment on the pleadings, arguing that the motion was moot. On May 10, 2018, the Court issued an order confirming that the motion was moot. On May 14, 2018, we filed our response to the renewed motion to strike and for judgment on the pleadings, and on May 18, 2018, the Maryland Attorney General filed its reply. On July 25, 2018, the Court held a hearing on the Maryland Attorney General’s renewed motion to strike and for judgment on the pleadings. On July 26, 2018, the Court denied the motion. The Court also scheduled a pretrial conference for September 7, 2018. On May 30, 2018, the Attorney General of the State of Minnesota and the Minnesota Board of Pharmacy filed a complaint against us in the Hennepin County District Court, State of Minnesota. The complaint asserts claims related to alleged deceptive acts and practices and consumer fraud, as well as claims under the Minnesota Wholesale Drug Distribution Licensing Act (Minn. Stat. § 151.461). On the same day, the Minnesota Board of Pharmacy filed an administrative action against us before the State of Minnesota Office of Administrative Hearings for the Board of Pharmacy, which seeks a determination regarding whether certain alleged conduct by Insys constitutes grounds for disciplinary action. We have not yet responded to either action. Multi-District Prescription Opioid Litigation . We have been named along with various other opioid manufacturers, opioid distributors, prescribers, pharmacies, and others in complaints focused on the national opioid epidemic filed by various cities, counties, states, Native American tribes, and third-party payers in many state and federal courts in Alabama, Arizona, Arkansas, California, Connecticut, Florida, Georgia, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah and West Virginia. We are involved in approximately 500 of these cases, the majority of which have been consolidated into multi-district litigation (No. 2804) in the Northern District of Ohio. Most of the cases in the multi-district litigation are presently stayed while the Court seeks to facilitate a resolution. On April 2, 2018, the United States filed a motion to participate in settlement discussions and as a friend of the court. Additionally, the Court set certain cases for a litigation track, and those cases will move forward toward trial, which is scheduled to commence on March 18, 2019. Putative Class Action Litigation . We have been named, along with various other opioid manufacturers and distributors, in putative class action complaints that seek to assert claims allegedly related to the national opioid epidemic on behalf of purchasers of health insurance between 1996 and the present in the states of California, Illinois, Massachusetts, New Jersey, and New York. Congressional and Other Inquiries . Many federal agencies and branches are focused on the abuse of opioids in the United States and agencies such as the HHS have expressed their belief that the United States is in the midst of a prescription opioid abuse epidemic. Moreover, President Trump has declared the opioid crisis to be a public health emergency and has made it a priority to address this crisis. Members of our U.S. Congress have been conducting hearings and other inquiries into causes and solutions to the national opioid epidemic that have involved inquiries into our Company’s practices. For example, on March 28, 2017, the Ranking Member of the Committee on Homeland Security and Governmental Affairs of the United States Senate distributed a letter to five manufacturers of opioid products, including us, requesting documents and information intended to aid such committee in understanding the challenges industry practices pose to efforts to curb opioid addiction and stem rising prescription drug costs for the federal government. This letter requested documents regarding our business, including the commercialization of SUBSYS®. This inquiry continues and has resulted in at least three reports that mention or address our Company. We continue to cooperate with this inquiry. Similarly, on August 2, 2018, bipartisan leaders of the House of Representatives Committee on Energy and Commerce sent letters to three manufacturers of opioid products, including us, requesting documents and information intended to aid such committee in investigating potential breakdowns in the controlled substances supply chain which may have contributed to the nation’s opioid epidemic. This letter requested documents regarding our business, sales practices, and speaker programs. We intend to cooperate with this inquiry. With the exception of the investigations by the ODOJ, the State of New Hampshire, the State of Illinois, the State of Massachusetts, and the DOJ, which we have quantified above, we believe a loss from an unfavorable outcome of these federal and state governmental proceedings is reasonably possible and an estimate of the amount or range of loss from an unfavorable outcome is not determinable at these stages. We believe we have meritorious legal positions and will continue to represent our interests vigorously in these matters. However, responding to government investigations has and could continue to burden us with substantial legal costs in connection with defending any claims raised. Any potential resulting fines, restitution, damages and penalties, settlement payments, pleas or exclusion from federal health care programs or other administrative actions, as well as any related actions brought by stockholders or other third parties, could have a material adverse effect on our financial position, results of operations or cash flows. Additionally, these matters could also have a negative impact on our reputation and divert the attention of our management from operating our business. Federal Securities Litigation and Derivative Complaints Federal Securities Litigation. On or about February 2, 2016, a complaint (captioned Richard Di Donato v. Insys Therapeutics, Inc., et al., Case 2:16-cv-00302-NVW) was filed in the United States District Court for the District of Arizona against us and certain of our current and former officers. The complai |
Note 8 - Stock-based Compensati
Note 8 - Stock-based Compensation | 6 Months Ended |
Jun. 30, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-based Compensation | 8. Stock-based Compensation Amounts recognized in the condensed consolidated statements of operations and comprehensive loss with respect to our stock-based compensation plans were as follows (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2018 2017 2018 2017 Research and development $ 736 $ 784 $ 1,583 $ 1,817 General and administrative 2,648 3,504 4,971 6,463 Total cost of stock-based compensation $ 3,384 $ 4,288 $ 6,554 $ 8,280 The following table summarizes stock option activity during the six months ended June 30, 2018: Weighted Weighted Average Aggregate Average Remaining Intrinsic Number of Exercise Contractual Value Shares Price Term (in years) (in millions) Vested and exercisable as of December 31, 2017 3,499,957 $ 11.43 Outstanding as of December 31, 2017 6,332,415 $ 12.10 Granted 1,305,700 $ 7.88 Cancelled (605,506 ) $ 14.03 Exercised (409,129 ) $ 2.30 Outstanding as of June 30, 2018 6,623,480 $ 11.69 7.6 $ 5.5 Vested and exercisable as of June 30, 2018 3,412,459 $ 12.47 6.3 $ 4.8 As of June 30, 2018, we expected to recognize $20,394,000 of stock-based compensation for outstanding options over a weighted-average period of 2.6 years. From time to time we grant restricted stock units to certain employees and directors. Restricted stock units are valued at the closing market price of our common stock on the day of grant and the total value of the units is recognized as expense ratably over the vesting period of the grants. The following table summarizes restricted stock unit activity during the six months ended June 30, 2018: Weighted Average Grant-Date Number of Fair Value Units Per Unit Outstanding as of December 31, 2017 381,900 $ 10.27 Granted 283,770 $ 8.04 Exercised (53,910 ) $ 12.65 Cancelled (35,637 ) $ 8.86 Outstanding as of June 30, 2018 576,123 $ 9.04 As of June 30, 2018, we expected to recognize $3,925,000 of stock-based compensation for outstanding restricted stock units over a weighted-average period of 2.0 years. Cash received from option exercises under all stock-based payment arrangements for the six months ended June 30, 2018 and 2017 was $916,000 and $2,331,000, respectively. For the six months ended June 30, 2018 and 2017, we recorded net reductions of $2,210,000 and $108,000, respectively, of our federal and state income tax liability, with an offsetting credit within income tax expense, resulting from the excess tax benefits of stock options. A full valuation allowance was recorded against these reductions during the six months ended June 30, 2018. |
Note- 9 - Net Loss per Share
Note- 9 - Net Loss per Share | 6 Months Ended |
Jun. 30, 2018 | |
Earnings Per Share [Abstract] | |
Net Loss per Share | 9. Net Loss per Share Basic net loss per common share is computed by dividing the net loss allocable to the common stockholders by the weighted average number of common shares outstanding during the period. The diluted income per share further includes any common shares available to be issued upon exercise of outstanding stock options if such inclusion would be dilutive. The following table sets forth the computation of basic and diluted net loss per common share (dollars in thousands, except per share amounts): Three Months Ended Six Months Ended June 30, June 30, 2018 2017 2018 2017 Historical net loss per share - Basic Numerator: Net loss $ (27,350 ) $ (8,184 ) $ (47,720 ) $ (14,708 ) Denominator: Weighted average number of common shares outstanding 73,920,645 72,169,361 73,832,924 72,057,552 Basic net loss per common share $ (0.37 ) $ (0.11 ) $ (0.65 ) $ (0.20 ) Historical net loss per share - Diluted Numerator: Net loss $ (27,350 ) $ (8,184 ) $ (47,720 ) $ (14,708 ) Denominator: Weighted average number of common shares outstanding 73,920,645 72,169,361 73,832,924 72,057,552 Effect of dilutive stock options — — — — Weighted average number of common shares outstanding 73,920,645 72,169,361 73,832,924 72,057,552 Diluted net loss per common share $ (0.37 ) $ (0.11 ) $ (0.65 ) $ (0.20 ) As we have incurred a net loss for the six months ended June 30, 2018 and 2017, basic and diluted per share amounts are the same, since the effect of potential common share equivalents is anti-dilutive. |
Note 10 - Product Lines, Concen
Note 10 - Product Lines, Concentration of Credit Risk and Significant Customers | 6 Months Ended |
Jun. 30, 2018 | |
Segment Reporting [Abstract] | |
Product Lines, Concentration of Credit Risk and Significant Customers | 10. Product Lines, Concentration of Credit Risk and Significant Customers We are engaged in the business of developing and selling pharmaceutical products. During the three and six months ended June 30, 2018, we had two product lines, SUBSYS® and SYNDROS®. Our CODM evaluates revenues based on product lines. The following tables summarizes our net revenue by product line, as well as the percentage of revenue by route to market (in thousands): Net Revenue by Product Line Three Months Ended Six Months Ended June 30, June 30, 2018 2017 2018 2017 SUBSYS ® $ 22,470 $ 42,576 $ 45,744 $ 78,538 SYNDROS ® 996 — 1,633 — Total net revenue $ 23,466 $ 42,576 $ 47,377 $ 78,538 Percent of Revenue by Route to Market Three Months Ended Six Months Ended June 30, June 30, 2018 2017 2018 2017 Pharmaceutical wholesalers 59 % 59 % 60 % 62 % Specialty pharmaceutical retailers 41 % 41 % 40 % 38 % 100 % 100 % 100 % 100 % All our products are sold in the United States of America. Product shipments to our three largest pharmaceutical wholesalers accounted for 31%, 15% and 11% of total shipments and product shipments to our two largest specialty pharmaceutical retailers accounted for 22% and 17% of total shipments for the six months ended June 30, 2018. Product shipments to our three largest pharmaceutical wholesalers accounted for 24%, 18%, and 11% of total shipments and product shipments to our two largest specialty pharmaceutical retailers accounted for 27% and 11% of total shipments for the six months ended June 30, 2017. Our three largest pharmaceutical wholesalers’ accounts receivable balances accounted for 43%, 12%, and 11% of gross accounts receivable and our two largest specialty pharmaceutical retailers’ accounts receivable balances accounted for 22% and 15% of gross accounts receivable balance as of June 30, 2018. Three pharmaceutical wholesalers’ accounts receivable balances accounted for 44%, 18%, and 10% of gross accounts receivable balance as of December 31, 2017, and two specialty pharmaceutical retailers’ accounts receivable balances accounted for 13% and 12% of gross accounts receivable as of December 31, 2017. |
Nature of Business and Basis of
Nature of Business and Basis of Presentation (Policies) | 6 Months Ended |
Jun. 30, 2018 | |
Accounting Policies [Abstract] | |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements Effective January 1, 2018, we adopted the requirements of ASU No. 2014-09, “Revenue from Contracts with Customers (ASC Topic 606),” and all the related amendments (“new revenue standard”). The new revenue standard aims to achieve a consistent application of revenue recognition within the United States, resulting in a single revenue model to be applied by reporting companies under U.S. GAAP. Under the new model, recognition of revenue occurs when a customer obtains control of promised goods or services in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. In addition, the new revenue standard requires that reporting companies disclose the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers. We used the modified retrospective transition method for all contracts that were not completed as of the adoption date. In addition, we have applied the practical expedient to contract modifications, as allowed by the SEC, but did not have any material contract modifications to be included in the initial adoption of ASC Topic 606. The comparative information in these condensed consolidated financial statements has not been restated and continues to be reported under ASC Topic 605, “Revenue Recognition.” We expect the impact of the adoption of the new standard to be immaterial to our net income (loss) on an ongoing basis. We recognize revenue when we transfer control of our products to our customers, as our contracts have a single performance obligation (delivery of our product to their preferred location). Our sales revenue from SUBSYS® continues to be recognized when product is delivered to wholesale pharmaceutical distributors and specialty retail pharmacies (collectively, our customers). In accordance with the new revenue standard, our sales revenue from SYNDROS® is now recognized when product is delivered to our customers, where revenue was previously deferred until the right of return no longer existed, which occurred at the earlier of the time SYNDROS® units were sold to health care facilities or dispensed through patient prescriptions, or the expiration of the right of return. It is common for our contracts to include product sales allowances that can decrease the transaction price and are therefore considered to be variable consideration. In accordance with the new revenue standard, we estimate the amount of variable consideration promised in the contract using the expected value (probability weighted estimate) method. We do not have any significant extended payment terms as payment is received shortly after the point of sale. See Note 2, Revenue Recognition The cumulative effect of the changes made to our January 1, 2018 condensed consolidated balance sheets for the adoption of the new revenue standard was as follows (in thousands): Balance at December 31, 2017 Adjustments due to adoption of ASC Topic 606 Balance at January 1, 2018 Condensed Consolidated Balance Sheets: Inventories, net 17,408 (59 ) 17,349 Accrued sales allowances 16,290 320 16,610 Deferred revenue 1,109 (1,109 ) — Accumulated deficit (215,351 ) 848 (214,503 ) The impact of adopting the new revenue standard on our condensed consolidated statements of operations and comprehensive loss Three Months Ended Six Months Ended June 30, 2018 June 30, 2018 Balances without Adopting ASC Topic 606 Impact of Adopting ASC Topic 606 As Reported Balances without Adopting ASC Topic 606 Impact of Adopting ASC Topic 606 As Reported Condensed Consolidated Statements of Operations and Comprehensive Loss: Net revenue $ 23,432 $ 34 $ 23,466 $ 47,178 199 $ 47,377 Cost of revenue 3,592 4 3,596 5,786 14 5,800 Gross profit 19,840 30 19,870 41,392 185 41,577 Operating loss (27,735 ) 30 (27,705 ) (48,123 ) 185 (47,938 ) Loss before income taxes (27,254 ) 30 (27,224 ) (47,608 ) 185 (47,423 ) Net loss (27,380 ) 30 (27,350 ) (47,905 ) 185 (47,720 ) The impact of adopting the new revenue standard on our condensed consolidated balance sheets was as follows (in thousands): June 30, 2018 Balances without Adopting ASC Topic 606 Impact of Adopting ASC Topic 606 As Reported Condensed Consolidated Balance Sheets: Inventories, net $ 9,928 73 $ 10,001 Total current assets 156,041 73 156,114 Total assets 235,072 73 235,145 Accrued sales allowances 12,353 229 12,582 Deferred revenue 1,537 (1,537 ) — Total liabilities 211,816 (1,308 ) 210,508 Accumulated deficit (262,408 ) 185 (262,223 ) Total stockholders' equity 24,452 185 24,637 Effective January 1, 2018, we adopted ASU No. 2016-01, “Financial Instruments—Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities,” and ASU No. 2018-03, “Technical Corrections and Improvements to Financial Instruments—Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities.” These standards amended the Financial Instruments topic of the ASC to address certain aspects of recognition, measurement, presentation, and disclosure of financial instruments. The standard requires that unrealized gains and losses on investments in equity securities to be recognized in net income (loss). The adoption of this guidance did not have a material impact on our condensed consolidated financial statements. Effective January 1, 2018, we adopted ASU No. 2016-15, “Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments.” The guidance clarifies how certain cash flow transactions are classified in the statement of cash flows. The adoption of this guidance did not have a material impact on our condensed consolidated financial statements. Effective January 1, 2018, we adopted ASU No. 2016-16, “Income Taxes (Topic 740): Intra-Entity Transfers of Assets Other Than Inventory.” Prior to January 1, 2018, U. S. GAAP prohibited the recognition of current and deferred income taxes for an intra-entity asset transfer until the asset was sold to an outside party, which was an exception to the principle of comprehensive recognition of current and deferred income taxes in U. S. GAAP. This guidance eliminates the exception for an intra-entity transfer of an asset other than inventory. The adoption of this guidance did not have a material impact on our condensed consolidated financial statements. Effective January 1, 2018, we adopted ASU No. 2017-09, “Compensation—Stock Compensation (Topic 718): Scope of Modification Accounting.” The ASU requires modification accounting to a share-based payment award unless all of the following are the same immediately before and after the change: the award’s fair value; the award’s vesting conditions; and the award’s classification as an equity instrument or a liability instrument. The adoption of this guidance did not have a material impact on our condensed consolidated financial statements. Effective January 1, 2018, we adopted ASU No. 2018-05, “Income Taxes (Topic 740): Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 118 (SEC Update).” The standard addresses any uncertainty or diversity of views in practice regarding the application of ASC Topic 740 in situations where a registrant did not have the necessary information available, prepared, or analyzed (including computations) in reasonable detail to complete the accounting under ASC Topic 740 for certain income tax effects of the 2017 Tax Cuts and Jobs Act (the “Act”) for the reporting period in which the Act was enacted. The Company recognized the provisional tax impacts of the Act in the fourth quarter of 2017. During the first quarter of 2018, the Company did not identify any additional information regarding these provisional calculations. As a result, the Company continues to anticipate finalizing its analysis in connection with the completion of the Company's tax return for 2017 to be filed in 2018. In June 2018, the FASB issued ASU No. 2018-07, “Compensation—Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting.” The standard expands the scope of ASC Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees, and supersedes ASC Topic 505-50, “Equity – Equity Based Payments to Non-Employees.” Previously, the fair value of share-based payment awards to nonemployees was determined by the measurement date, which was the earlier of the date at which a commitment for performance by the counterparty is reached or the date at which the counterparty’s performance is complete. This concept caused significant differences in the accounting for share-based payment to nonemployees as compared to share-based payments to employees. Furthermore, the previous guidance required employers to revalue share-based payments to nonemployees at each reporting period if a measurement date could not be established, causing fluctuations in the resulting expense from period to period. The new standard eliminates the measurement date concept and requires the fair value of share-based payments to nonemployees to be measured on the grant date, consistent with share-based payments to employees. We early adopted the standard during the three months ended June 30, 2018. We remeasured the fair value of our equity-classified share-based payments to nonemployees for which a measurement date had not been established as of the adoption date of January 1, 2018. Because we had previously remeasured our share-based payments to nonemployees at each reporting period, the adoption did not result in a cumulative effect adjustment to opening retained earnings. The impact of this adoption on the condensed consolidated financial statements for the three months ended March 31, 2018 was an increase to stock-based compensation reported in general and administrative expenses of approximately $259,000, with an offset to additional paid-in capital. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In March 2017, the FASB issued ASU No. 2017-08, “Receivables—Nonrefundable Fees and Other Costs (Subtopic 310-20): Premium Amortization on Purchased Callable Debt Securities,” to amend the amortization period for certain purchased callable debt securities held at a premium. The ASU shortens the amortization period for the premium to the earliest call date. Under current U.S. GAAP, entities generally amortize the premium as an adjustment of yield over the contractual life of the instrument. The amendments should be applied on a modified retrospective basis and are effective for fiscal years beginning after December 15, 2018. Early adoption is permitted, including adoption in an interim period. We are currently evaluating the impact of this amendment on our condensed consolidated financial statements. In June 2016, the FASB issued ASU No. 2016-13, “Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments.” The amendments effected by this ASU affect entities holding financial assets and net investment in leases that are not accounted for at fair value through net income and are effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years, and early adoption is permitted. ASU 2016-13 amends the impairment model to utilize an expected loss methodology in place of the currently used incurred loss methodology, which will result in the timelier recognition of losses. We do not expect this amendment to have a material impact on our condensed consolidated financial statements. In February 2016, the FASB issued ASU No. 2016-02, “Leases: (Topic 842),” to provide guidance on recognizing lease assets and lease liabilities on the balance sheet and disclosing key information about leasing arrangements, specifically differentiating between different types of leases. The core principle of Topic 842 is that a lessee should recognize the assets and liabilities that arise from all leases. The recognition, measurement, and presentation of expenses and cash flows arising from a lease by a lessee have not significantly changed from previous U.S. GAAP guidance. There continues to be a differentiation between finance leases and operating leases. However, the principal difference from previous guidance is that the lease assets and lease liabilities arising from operating leases should be recognized in the balance sheet. The accounting applied by a lessor is largely unchanged from that applied under previous U.S. GAAP guidance. The amendments will be effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years, and early adoption is permitted. In transition, lessees and lessors are required to recognize and measure leases at the beginning of the earliest period presented using a modified retrospective approach. The modified retrospective approach includes a number of optional practical expedients that entities may elect to apply. These practical expedients relate to the identification and classification of leases that commenced before the effective date, initial direct costs for leases that commenced before the effective date, and the ability to use hindsight in evaluating lessee options to extend or terminate a lease or to purchase the underlying asset. An entity that elects to apply the practical expedients will, in effect, continue to account for leases that commenced before the effective date in accordance with previous U.S. GAAP guidance unless the lease is modified, except that lessees are required to recognize a right-of-use asset and a lease liability for all operating leases at each reporting date based on the present value of the remaining minimum rental payments that were tracked and disclosed under previous U.S. GAAP guidance. We currently expect that most of our operating lease commitments will be subject to the update and recognized as right-of-use assets and operating lease liabilities upon adoption. We expect the standard to have a material impact on our assets and liabilities for the addition of right-of-use assets and lease liabilities, but we do not expect it to have a material impact to our results of operations or liquidity. |
Note 1 - Nature of Business a18
Note 1 - Nature of Business and Basis of Presentation (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
ASC Topic 606 (Revenue from Contracts with Customers) [Member] | |
Schedule of Impact of Adoption of New Revenue Standard | The cumulative effect of the changes made to our January 1, 2018 condensed consolidated balance sheets for the adoption of the new revenue standard was as follows (in thousands): Balance at December 31, 2017 Adjustments due to adoption of ASC Topic 606 Balance at January 1, 2018 Condensed Consolidated Balance Sheets: Inventories, net 17,408 (59 ) 17,349 Accrued sales allowances 16,290 320 16,610 Deferred revenue 1,109 (1,109 ) — Accumulated deficit (215,351 ) 848 (214,503 ) The impact of adopting the new revenue standard on our condensed consolidated statements of operations and comprehensive loss Three Months Ended Six Months Ended June 30, 2018 June 30, 2018 Balances without Adopting ASC Topic 606 Impact of Adopting ASC Topic 606 As Reported Balances without Adopting ASC Topic 606 Impact of Adopting ASC Topic 606 As Reported Condensed Consolidated Statements of Operations and Comprehensive Loss: Net revenue $ 23,432 $ 34 $ 23,466 $ 47,178 199 $ 47,377 Cost of revenue 3,592 4 3,596 5,786 14 5,800 Gross profit 19,840 30 19,870 41,392 185 41,577 Operating loss (27,735 ) 30 (27,705 ) (48,123 ) 185 (47,938 ) Loss before income taxes (27,254 ) 30 (27,224 ) (47,608 ) 185 (47,423 ) Net loss (27,380 ) 30 (27,350 ) (47,905 ) 185 (47,720 ) The impact of adopting the new revenue standard on our condensed consolidated balance sheets was as follows (in thousands): June 30, 2018 Balances without Adopting ASC Topic 606 Impact of Adopting ASC Topic 606 As Reported Condensed Consolidated Balance Sheets: Inventories, net $ 9,928 73 $ 10,001 Total current assets 156,041 73 156,114 Total assets 235,072 73 235,145 Accrued sales allowances 12,353 229 12,582 Deferred revenue 1,537 (1,537 ) — Total liabilities 211,816 (1,308 ) 210,508 Accumulated deficit (262,408 ) 185 (262,223 ) Total stockholders' equity 24,452 185 24,637 |
Note 3 - Short-term and Long-19
Note 3 - Short-term and Long-term Investments (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Schedule Of Investments [Abstract] | |
Summary of Investments | Investments consisted of the following at June 30, 2018 (in thousands): Cost Unrealized Gains Unrealized Losses Other- Than- Temporary Impairment Losses Fair Value Cash and Cash Equivalents Short-term Investments Long-term Investments Cash and cash equivalents $ 6,425 $ — $ — $ — $ 6,425 $ 6,425 $ — $ — Money market securities 9,066 — — — 9,066 9,066 — — Marketable securities: Certificates of deposit 14,528 — — — 14,528 — 7,827 6,701 Commercial paper 15,228 — — — 15,228 599 14,629 — Corporate securities 44,159 — (222 ) — 43,937 — 41,488 2,449 Federal agency securities 29,877 — (205 ) — 29,672 — 20,568 9,104 Municipal securities 4,663 — (11 ) — 4,652 — 4,301 351 Total marketable securities 108,455 — (438 ) — 108,017 599 88,813 18,605 $ 123,946 $ — $ (438 ) $ — $ 123,508 $ 16,090 $ 88,813 $ 18,605 Investments consisted of the following at December 31, 2017 (in thousands): Cost Unrealized Gains Unrealized Losses Other- Than- Temporary Impairment Losses Fair Value Cash and Cash Equivalents Short-term Investments Long-term Investments Cash and cash equivalents $ 12,183 $ — $ — $ — $ 12,183 $ 12,183 $ — $ — Money market securities 15,317 — — — 15,317 15,317 — — Marketable securities: Certificates of deposit 18,447 — — — 18,447 — 7,474 10,973 Commercial paper 10,560 — — — 10,560 1,499 9,061 — Corporate securities 59,613 — (206 ) — 59,407 1,500 39,622 18,285 Federal agency securities 37,793 — (203 ) — 37,590 1,500 20,015 16,075 Municipal securities 10,446 — (29 ) — 10,417 — 9,017 1,400 Total marketable securities 136,859 — (438 ) — 136,421 4,499 85,189 46,733 $ 164,359 $ — $ (438 ) $ — $ 163,921 $ 31,999 $ 85,189 $ 46,733 |
Summary of Amortized Cost and Estimated Fair Value of Securities By Maturity | The amortized cost and estimated fair value of the marketable securities by maturity, are shown below (in thousands): June 30, 2018 December 31, 2017 Amortized Cost Fair Value Amortized Cost Fair Value Marketable securities: Due in one year or less $ 89,618 $ 89,362 $ 90,071 $ 89,937 Due after one year through 5 years 18,537 18,355 46,788 46,484 Due after 5 years through 10 years — — — — Due after 10 years 300 300 — — $ 108,455 $ 108,017 $ 136,859 $ 136,421 |
Summary of Gross Unrealized Losses and Fair Value of Investments | The following table shows the gross unrealized losses and the fair value of our investments, with unrealized losses that are not deemed to be other-than-temporarily impaired aggregated by investment category and length of time that individual securities have been in a continuous unrealized loss position (in thousands): June 30, 2018 December 31, 2017 Less Than 12 Months Greater Than 12 Months Less Than 12 Months Greater Than 12 Months Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss Marketable securities: Corporate securities $ 28,904 $ (135 ) $ 14,023 $ (87 ) $ 245 $ (153 ) $ 7,839 $ (52 ) Federal agency securities 17,362 (113 ) 11,911 (92 ) 26,244 (89 ) 11,346 (114 ) Municipal securities 2,358 (5 ) 1,030 (6 ) 50,537 (18 ) 1,145 (12 ) $ 48,624 $ (253 ) $ 26,964 $ (185 ) $ 77,026 $ (260 ) $ 20,330 $ (178 ) |
Note 4 - Fair Value Measureme20
Note 4 - Fair Value Measurement (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Fair Value Disclosures [Abstract] | |
Summary of Assets and Liabilities Measured at Fair Value on Recurring and Nonrecurring Basis | Our assets and liabilities subject to the disclosure requirements of ASC Topic 820 at June 30, 2018, were as follows (in thousands): Fair Value Measurement at Reporting Date Total Quoted Prices in active Markets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Gains (Losses) Recurring fair value measurements Marketable securities: Certificates of deposit $ 14,528 $ — $ 14,528 $ — Commercial paper 15,228 — 15,228 — Corporate securities 43,937 — 43,419 518 Federal agency securities 29,672 — 29,672 — Municipal securities 4,652 — 4,652 — Total recurring fair value measurements $ 108,017 $ — $ 107,499 $ 518 Nonrecurring fair value measurements Property and equipment (see Note 6) — — — — $ (1,487 ) Total nonrecurring fair value measurements $ — $ — $ — $ — $ (1,487 ) Our assets and liabilities subject to the disclosure requirements of ASC Topic 820 at December 31, 2017, were as follows (in thousands): Fair Value Measurement at Reporting Date Total Quoted Prices in active Markets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Recurring fair value measurements Marketable securities: Certificates of deposit $ 18,447 $ — $ 18,447 $ — Commercial paper 10,560 — 10,560 — Corporate securities 59,407 — 58,889 518 Federal agency securities 37,590 — 37,590 — Municipal securities 10,417 — 10,417 — Total recurring fair value measurements $ 136,421 $ — $ 135,903 $ 518 |
Summary of Additional Information about Assets Measured at Fair Value | The following table presents additional information about assets measured at fair value on a recurring basis and for which we utilize Level 3 inputs to determine fair value for the three and six months ended June 30, 2018 and 2017 (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2018 2017 2018 2017 Convertible preferred stock Balance, beginning of period $ 518 $ 518 $ 518 $ 500 Change in fair value — — — 18 Balance, end of period $ 518 $ 518 $ 518 $ 518 |
Note 5 - Inventories, Net (Tabl
Note 5 - Inventories, Net (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Inventory Disclosure [Abstract] | |
Schedule of Components of Inventories Net of Allowances | The components of inventories, net of allowances, are as follows (in thousands): June 30, December 31, 2018 2017 Finished goods $ 2,521 $ 4,709 Work-in-process 4,302 5,752 Raw materials and supplies 3,178 6,947 Total inventories 10,001 17,408 Plus: non-current raw materials and finished goods 6,358 826 $ 16,359 $ 18,234 |
Note 7 - Commitments and Cont22
Note 7 - Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
Summary of Aggregate Minimum Purchase Commitments and Exclusive Supply Rights | The following table sets forth our aggregate minimum purchase commitments and exclusive supply rights with Renaissance and Aptar under these agreements (in thousands): Years ending December 31, Remainder of 2018 $ 2,370 2019 4,000 2020 4,000 2021 2,000 2022 — Thereafter — Total $ 12,370 |
Note 8 - Stock-based Compensa23
Note 8 - Stock-based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Amounts Recognized in Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) with Respect to Stock-Based Compensation Plans | Amounts recognized in the condensed consolidated statements of operations and comprehensive loss with respect to our stock-based compensation plans were as follows (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2018 2017 2018 2017 Research and development $ 736 $ 784 $ 1,583 $ 1,817 General and administrative 2,648 3,504 4,971 6,463 Total cost of stock-based compensation $ 3,384 $ 4,288 $ 6,554 $ 8,280 |
Summary of Stock Option Activity | The following table summarizes stock option activity during the six months ended June 30, 2018: Weighted Weighted Average Aggregate Average Remaining Intrinsic Number of Exercise Contractual Value Shares Price Term (in years) (in millions) Vested and exercisable as of December 31, 2017 3,499,957 $ 11.43 Outstanding as of December 31, 2017 6,332,415 $ 12.10 Granted 1,305,700 $ 7.88 Cancelled (605,506 ) $ 14.03 Exercised (409,129 ) $ 2.30 Outstanding as of June 30, 2018 6,623,480 $ 11.69 7.6 $ 5.5 Vested and exercisable as of June 30, 2018 3,412,459 $ 12.47 6.3 $ 4.8 |
Summary of Restricted Stock Unit Activity | The following table summarizes restricted stock unit activity during the six months ended June 30, 2018: Weighted Average Grant-Date Number of Fair Value Units Per Unit Outstanding as of December 31, 2017 381,900 $ 10.27 Granted 283,770 $ 8.04 Exercised (53,910 ) $ 12.65 Cancelled (35,637 ) $ 8.86 Outstanding as of June 30, 2018 576,123 $ 9.04 |
Note- 9 - Net Loss Per Share (T
Note- 9 - Net Loss Per Share (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Earnings Per Share [Abstract] | |
Schedule of Computation of Basic and Diluted Net Loss Per Common Share | The following table sets forth the computation of basic and diluted net loss per common share (dollars in thousands, except per share amounts): Three Months Ended Six Months Ended June 30, June 30, 2018 2017 2018 2017 Historical net loss per share - Basic Numerator: Net loss $ (27,350 ) $ (8,184 ) $ (47,720 ) $ (14,708 ) Denominator: Weighted average number of common shares outstanding 73,920,645 72,169,361 73,832,924 72,057,552 Basic net loss per common share $ (0.37 ) $ (0.11 ) $ (0.65 ) $ (0.20 ) Historical net loss per share - Diluted Numerator: Net loss $ (27,350 ) $ (8,184 ) $ (47,720 ) $ (14,708 ) Denominator: Weighted average number of common shares outstanding 73,920,645 72,169,361 73,832,924 72,057,552 Effect of dilutive stock options — — — — Weighted average number of common shares outstanding 73,920,645 72,169,361 73,832,924 72,057,552 Diluted net loss per common share $ (0.37 ) $ (0.11 ) $ (0.65 ) $ (0.20 ) |
Note 10 - Product Lines, Conc25
Note 10 - Product Lines, Concentration of Credit Risk and Significant Customers (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Segment Reporting [Abstract] | |
Summary of Net Revenue by Product Line | The following tables summarizes our net revenue by product line, as well as the percentage of revenue by route to market (in thousands): Net Revenue by Product Line Three Months Ended Six Months Ended June 30, June 30, 2018 2017 2018 2017 SUBSYS ® $ 22,470 $ 42,576 $ 45,744 $ 78,538 SYNDROS ® 996 — 1,633 — Total net revenue $ 23,466 $ 42,576 $ 47,377 $ 78,538 |
Percentage of Revenue by Route to Market | Percent of Revenue by Route to Market Three Months Ended Six Months Ended June 30, June 30, 2018 2017 2018 2017 Pharmaceutical wholesalers 59 % 59 % 60 % 62 % Specialty pharmaceutical retailers 41 % 41 % 40 % 38 % 100 % 100 % 100 % 100 % |
Note 1 - Nature of Business a26
Note 1 - Nature of Business and Basis of Presentation (Details Textual) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2018USD ($)ProductLine | Mar. 31, 2018USD ($) | Jun. 30, 2017USD ($) | Jun. 30, 2018USD ($)ProductLine | Jun. 30, 2017USD ($) | |
Nature Of Business [Line Items] | |||||
Number of Product Lines | ProductLine | 2 | 2 | |||
Stock-based compensation expenses | $ 3,384,000 | $ 4,288,000 | $ 6,554,000 | $ 8,280,000 | |
General and Administrative Expense [Member] | |||||
Nature Of Business [Line Items] | |||||
Stock-based compensation expenses | $ 2,648,000 | $ 3,504,000 | $ 4,971,000 | $ 6,463,000 | |
ASC Topic 718 (Compensation-Stock Compensation) [Member] | General and Administrative Expense [Member] | |||||
Nature Of Business [Line Items] | |||||
Stock-based compensation expenses | $ 259,000 |
Note 1 - Nature of Business a27
Note 1 - Nature of Business and Basis of Presentation - Schedule of Impact of Adoption of New Revenue Standard on Condensed Consolidated Balance Sheets (Details) - USD ($) $ in Thousands | Jun. 30, 2018 | Jan. 01, 2018 | Dec. 31, 2017 |
Condensed Consolidated Balance Sheets: | |||
Inventories, net | $ 10,001 | $ 17,408 | |
Accrued sales allowances | 12,582 | 16,290 | |
Deferred revenue | 1,109 | ||
Accumulated deficit | (262,223) | $ (215,351) | |
ASC Topic 606 (Revenue from Contracts with Customers) [Member] | |||
Condensed Consolidated Balance Sheets: | |||
Inventories, net | $ 17,349 | ||
Accrued sales allowances | 16,610 | ||
Accumulated deficit | (214,503) | ||
ASC Topic 606 (Revenue from Contracts with Customers) [Member] | Impact of Adopting ASC Topic 606 [Member] | |||
Condensed Consolidated Balance Sheets: | |||
Inventories, net | 73 | (59) | |
Accrued sales allowances | 229 | 320 | |
Deferred revenue | (1,537) | (1,109) | |
Accumulated deficit | $ 185 | $ 848 |
Note 1 - Nature of Business a28
Note 1 - Nature of Business and Basis of Presentation - Schedule of Impact of Adopting New Revenue on Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Condensed Consolidated Statements of Operations and Comprehensive Loss: | ||||
Net revenue | $ 23,466 | $ 42,576 | $ 47,377 | $ 78,538 |
Cost of revenue | 3,596 | 3,921 | 5,800 | 8,560 |
Gross profit | 19,870 | 38,655 | 41,577 | 69,978 |
Operating loss | (27,705) | (10,316) | (47,938) | (22,627) |
Loss before income taxes | (27,224) | (9,838) | (47,423) | (21,688) |
Net loss | (27,350) | $ (8,184) | (47,720) | $ (14,708) |
ASC Topic 606 (Revenue from Contracts with Customers) [Member] | Balances without Adopting ASC Topic 606 [Member] | ||||
Condensed Consolidated Statements of Operations and Comprehensive Loss: | ||||
Net revenue | 23,432 | 47,178 | ||
Cost of revenue | 3,592 | 5,786 | ||
Gross profit | 19,840 | 41,392 | ||
Operating loss | (27,735) | (48,123) | ||
Loss before income taxes | (27,254) | (47,608) | ||
Net loss | (27,380) | (47,905) | ||
ASC Topic 606 (Revenue from Contracts with Customers) [Member] | Impact of Adopting ASC Topic 606 [Member] | ||||
Condensed Consolidated Statements of Operations and Comprehensive Loss: | ||||
Net revenue | 34 | 199 | ||
Cost of revenue | 4 | 14 | ||
Gross profit | 30 | 185 | ||
Operating loss | 30 | 185 | ||
Loss before income taxes | 30 | 185 | ||
Net loss | $ 30 | $ 185 |
Note 1 - Nature of Business a29
Note 1 - Nature of Business and Basis of Presentation - Schedule of Impact of Adopting New Revenue on Balance Sheets (Details) - USD ($) $ in Thousands | Jun. 30, 2018 | Jan. 01, 2018 | Dec. 31, 2017 |
Condensed Consolidated Balance Sheets: | |||
Inventories, net | $ 10,001 | $ 17,408 | |
Total current assets | 156,114 | 175,942 | |
Total assets | 235,145 | 279,080 | |
Accrued sales allowances | 12,582 | 16,290 | |
Deferred revenue | 1,109 | ||
Total liabilities | 210,508 | 215,798 | |
Accumulated deficit | (262,223) | (215,351) | |
Total stockholders' equity | 24,637 | $ 63,282 | |
ASC Topic 606 (Revenue from Contracts with Customers) [Member] | |||
Condensed Consolidated Balance Sheets: | |||
Inventories, net | $ 17,349 | ||
Accrued sales allowances | 16,610 | ||
Accumulated deficit | (214,503) | ||
ASC Topic 606 (Revenue from Contracts with Customers) [Member] | Balances without Adopting ASC Topic 606 [Member] | |||
Condensed Consolidated Balance Sheets: | |||
Inventories, net | 9,928 | ||
Total current assets | 156,041 | ||
Total assets | 235,072 | ||
Accrued sales allowances | 12,353 | ||
Deferred revenue | 1,537 | ||
Total liabilities | 211,816 | ||
Accumulated deficit | (262,408) | ||
Total stockholders' equity | 24,452 | ||
ASC Topic 606 (Revenue from Contracts with Customers) [Member] | Impact of Adopting ASC Topic 606 [Member] | |||
Condensed Consolidated Balance Sheets: | |||
Inventories, net | 73 | (59) | |
Total current assets | 73 | ||
Total assets | 73 | ||
Accrued sales allowances | 229 | 320 | |
Deferred revenue | (1,537) | (1,109) | |
Total liabilities | (1,308) | ||
Accumulated deficit | 185 | $ 848 | |
Total stockholders' equity | $ 185 |
Note 2 - Revenue Recognition (D
Note 2 - Revenue Recognition (Details Textual) | 6 Months Ended |
Jun. 30, 2018 | |
SUBSYS [Member] | |
Revenue Recognition [Line Items] | |
Product Return, Period Prior to Expiration | 6 months |
Product Return, Period After Expiration | 12 months |
Cash Discount, Percent | 2.00% |
SUBSYS [Member] | Minimum [Member] | |
Revenue Recognition [Line Items] | |
Shelf Life of Product from Date of Manufacture | 36 months |
SUBSYS [Member] | Maximum [Member] | |
Revenue Recognition [Line Items] | |
Shelf Life of Product from Date of Manufacture | 48 months |
SYNDROS [Member] | |
Revenue Recognition [Line Items] | |
Product Return, Period Prior to Expiration | 6 months |
Product Return, Period After Expiration | 12 months |
Cash Discount, Percent | 2.00% |
SYNDROS [Member] | Minimum [Member] | |
Revenue Recognition [Line Items] | |
Shelf Life of Product from Date of Manufacture | 24 months |
SYNDROS [Member] | Maximum [Member] | |
Revenue Recognition [Line Items] | |
Shelf Life of Product from Date of Manufacture | 36 months |
Note 3 - Short-term and Long-31
Note 3 - Short-term and Long-term Investments (Details Textual) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | Dec. 31, 2017 | |
Schedule Of Investments [Line Items] | |||||
Reclassifications on available-for-sale securities | $ 0 | $ 0 | $ 0 | $ 0 | |
Investment Owned, at Fair Value | 123,508,000 | 123,508,000 | $ 163,921,000 | ||
Other than temporary impairment losses on available-for-sale securities | 0 | $ 0 | 0 | $ 0 | |
Certificates of Deposit [Member] | |||||
Schedule Of Investments [Line Items] | |||||
Investment Owned, at Fair Value | 599,000 | 599,000 | |||
Short-term Investments [Member] | |||||
Schedule Of Investments [Line Items] | |||||
Investment Owned, at Fair Value | 88,813,000 | 88,813,000 | |||
Long-term Investments [Member] | |||||
Schedule Of Investments [Line Items] | |||||
Investment Owned, at Fair Value | $ 18,605,000 | $ 18,605,000 |
Note 3 - Short-term and Long-32
Note 3 - Short-term and Long-term Investments - Summary of Investments (Details) - USD ($) $ in Thousands | Jun. 30, 2018 | Dec. 31, 2017 |
Schedule Of Investments [Line Items] | ||
Cash and cash equivalents, Cost | $ 16,090 | $ 31,999 |
Marketable securities, Cost | 108,455 | 136,859 |
Marketable securities, Unrealized Losses | (438) | (438) |
Marketable securities, Fair Value | 108,017 | 136,421 |
Short-term Investments | 88,813 | 85,189 |
Long-term Investments | 18,605 | 46,733 |
Cost | 123,946 | 164,359 |
Fair Value | 123,508 | 163,921 |
Commercial Paper [Member] | ||
Schedule Of Investments [Line Items] | ||
Cash and cash equivalents, Cost | 599 | 1,499 |
Marketable securities, Cost | 15,228 | 10,560 |
Marketable securities, Fair Value | 15,228 | 10,560 |
Short-term Investments | 14,629 | 9,061 |
Corporate Securities [Member] | ||
Schedule Of Investments [Line Items] | ||
Cash and cash equivalents, Cost | 1,500 | |
Marketable securities, Cost | 44,159 | 59,613 |
Marketable securities, Unrealized Losses | (222) | (206) |
Marketable securities, Fair Value | 43,937 | 59,407 |
Short-term Investments | 41,488 | 39,622 |
Long-term Investments | 2,449 | 18,285 |
Federal Agency Securities [Member] | ||
Schedule Of Investments [Line Items] | ||
Cash and cash equivalents, Cost | 1,500 | |
Marketable securities, Cost | 29,877 | 37,793 |
Marketable securities, Unrealized Losses | (205) | (203) |
Marketable securities, Fair Value | 29,672 | 37,590 |
Short-term Investments | 20,568 | 20,015 |
Long-term Investments | 9,104 | 16,075 |
Municipal Securities [Member] | ||
Schedule Of Investments [Line Items] | ||
Marketable securities, Cost | 4,663 | 10,446 |
Marketable securities, Unrealized Losses | (11) | (29) |
Marketable securities, Fair Value | 4,652 | 10,417 |
Short-term Investments | 4,301 | 9,017 |
Long-term Investments | 351 | 1,400 |
Marketable Securities [Member] | ||
Schedule Of Investments [Line Items] | ||
Cash and cash equivalents, Cost | 599 | 4,499 |
Marketable securities, Cost | 108,455 | 136,859 |
Marketable securities, Unrealized Losses | (438) | (438) |
Marketable securities, Fair Value | 108,017 | 136,421 |
Short-term Investments | 88,813 | 85,189 |
Long-term Investments | 18,605 | 46,733 |
Cash and Cash Equivalents [Member] | ||
Schedule Of Investments [Line Items] | ||
Cash and cash equivalents, Cost | 6,425 | 12,183 |
Cash and cash equivalents, Fair Value | 6,425 | 12,183 |
Money Market Securities [Member] | ||
Schedule Of Investments [Line Items] | ||
Cash and cash equivalents, Cost | 9,066 | 15,317 |
Cash and cash equivalents, Fair Value | 9,066 | 15,317 |
Certificates of Deposit [Member] | ||
Schedule Of Investments [Line Items] | ||
Marketable securities, Cost | 14,528 | 18,447 |
Marketable securities, Fair Value | 14,528 | 18,447 |
Short-term Investments | 7,827 | 7,474 |
Long-term Investments | $ 6,701 | $ 10,973 |
Note 3 - Short-term and Long-33
Note 3 - Short-term and Long-term Investments - Summary of Amortized Cost and Estimated Fair Value of Securities By Maturity (Details) - USD ($) $ in Thousands | Jun. 30, 2018 | Dec. 31, 2017 |
Marketable securities: | ||
Due in one year or less, Amortized Cost | $ 89,618 | $ 90,071 |
Due after one year through 5 years, Amortized Cost | 18,537 | 46,788 |
Due after 10 years, Amortized Cost | 300 | |
Marketable securities, Cost | 108,455 | 136,859 |
Due in one year or less, Fair Value | 89,362 | 89,937 |
Due after one year through 5 years, Fair Value | 18,355 | 46,484 |
Due after 10 years, Fair Value | 300 | |
Total, Fair value | $ 108,017 | $ 136,421 |
Note 3 - Short-term and Long-34
Note 3 - Short-term and Long-term Investments - Summary of Gross Unrealized Losses and Fair Value of Investments (Details) - USD ($) $ in Thousands | Jun. 30, 2018 | Dec. 31, 2017 |
Marketable securities: | ||
Less Than 12 Months Fair Value | $ 48,624 | $ 77,026 |
Less Than 12 Months Unrealized Loss | (253) | (260) |
Greater Than 12 Months Fair Value | 26,964 | 20,330 |
Greater Than 12 Months Unrealized Loss | (185) | (178) |
Corporate Bond Securities [Member] | ||
Marketable securities: | ||
Less Than 12 Months Fair Value | 28,904 | 245 |
Less Than 12 Months Unrealized Loss | (135) | (153) |
Greater Than 12 Months Fair Value | 14,023 | 7,839 |
Greater Than 12 Months Unrealized Loss | (87) | (52) |
Federal Agency Securities [Member] | ||
Marketable securities: | ||
Less Than 12 Months Fair Value | 17,362 | 26,244 |
Less Than 12 Months Unrealized Loss | (113) | (89) |
Greater Than 12 Months Fair Value | 11,911 | 11,346 |
Greater Than 12 Months Unrealized Loss | (92) | (114) |
Municipal Securities [Member] | ||
Marketable securities: | ||
Less Than 12 Months Fair Value | 2,358 | 50,537 |
Less Than 12 Months Unrealized Loss | (5) | (18) |
Greater Than 12 Months Fair Value | 1,030 | 1,145 |
Greater Than 12 Months Unrealized Loss | $ (6) | $ (12) |
Note 4 - Fair Value Measureme35
Note 4 - Fair Value Measurement (Details Textual) - USD ($) | Jun. 30, 2018 | Dec. 31, 2017 |
Fair Value Disclosures [Abstract] | ||
Assets measured at fair value on nonrecurring basis | $ 0 | $ 0 |
Liabilities measured at fair value on nonrecurring basis | $ 0 | $ 0 |
Note 4 - Fair Value Measureme36
Note 4 - Fair Value Measurement - Summary of Assets and Liabilities Measured at Fair Value on Recurring and Nonrecurring Basis (Detail) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2018 | Dec. 31, 2017 | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | $ 108,017 | $ 136,421 |
Total Gains (Losses), Property and equipment | (1,487) | |
Commercial Paper [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 15,228 | 10,560 |
Corporate Securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 43,937 | 59,407 |
Federal Agency Securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 29,672 | 37,590 |
Municipal Securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 4,652 | 10,417 |
Recurring Fair Value Measurements [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 108,017 | 136,421 |
Recurring Fair Value Measurements [Member] | Certificates of Deposit [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 14,528 | 18,447 |
Recurring Fair Value Measurements [Member] | Commercial Paper [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 15,228 | 10,560 |
Recurring Fair Value Measurements [Member] | Corporate Securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 43,937 | 59,407 |
Recurring Fair Value Measurements [Member] | Federal Agency Securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 29,672 | 37,590 |
Recurring Fair Value Measurements [Member] | Municipal Securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 4,652 | 10,417 |
Nonrecurring Fair Value Measurements [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total Gains (Losses), Property and equipment | (1,487) | |
Nonrecurring Fair Value Measurements [Member] | Property and Equipment [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total Gains (Losses), Property and equipment | (1,487) | |
Significant Other Observable Inputs (Level 2) [Member] | Recurring Fair Value Measurements [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 107,499 | 135,903 |
Significant Other Observable Inputs (Level 2) [Member] | Recurring Fair Value Measurements [Member] | Certificates of Deposit [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 14,528 | 18,447 |
Significant Other Observable Inputs (Level 2) [Member] | Recurring Fair Value Measurements [Member] | Commercial Paper [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 15,228 | 10,560 |
Significant Other Observable Inputs (Level 2) [Member] | Recurring Fair Value Measurements [Member] | Corporate Securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 43,419 | 58,889 |
Significant Other Observable Inputs (Level 2) [Member] | Recurring Fair Value Measurements [Member] | Federal Agency Securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 29,672 | 37,590 |
Significant Other Observable Inputs (Level 2) [Member] | Recurring Fair Value Measurements [Member] | Municipal Securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 4,652 | 10,417 |
Significant Unobservable Inputs (Level 3) [Member] | Recurring Fair Value Measurements [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 518 | 518 |
Significant Unobservable Inputs (Level 3) [Member] | Recurring Fair Value Measurements [Member] | Corporate Securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | $ 518 | $ 518 |
Note 4 - Fair Value Measureme37
Note 4 - Fair Value Measurement - Summary of Additional Information about Assets Measured at Fair Value (Detail) - Convertible Preferred Stock [Member] - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Fair Value Assets Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||||
Balance, beginning of period | $ 518 | $ 518 | $ 518 | $ 500 |
Change in fair value | 18 | |||
Balance, end of period | $ 518 | $ 518 | $ 518 | $ 518 |
Note 5 - Inventories, Net - Sch
Note 5 - Inventories, Net - Schedule of Components of Inventories Net of Allowances (Details) - USD ($) $ in Thousands | Jun. 30, 2018 | Dec. 31, 2017 |
Inventory Disclosure [Abstract] | ||
Finished goods | $ 2,521 | $ 4,709 |
Work-in-process | 4,302 | 5,752 |
Raw materials and supplies | 3,178 | 6,947 |
Total inventories | 10,001 | 17,408 |
Plus: non-current raw materials and finished goods | 6,358 | 826 |
Inventories, net | $ 16,359 | $ 18,234 |
Note 5 - Inventories, Net (Deta
Note 5 - Inventories, Net (Details Textual) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | Dec. 31, 2017 | |
Inventory [Line Items] | |||||
Inventory Valuation Reserves | $ 9,599,000 | $ 9,599,000 | $ 13,664,000 | ||
Inventory obsolescence reserve | 1,005,000 | $ 2,959,000 | |||
Increase (decrease) in inventory valuation reserves | (5,068,000) | $ 2,959,000 | (5,068,000) | $ 1,185,000 | |
Deferred cost of revenue | 0 | 0 | $ 59,000 | ||
Inventory Valuation and Obsolescence [Member] | |||||
Inventory [Line Items] | |||||
Inventory obsolescence reserve | $ 1,005,000 | $ 477,000 |
Note 6 - Property and Equipme40
Note 6 - Property and Equipment, Net (Details Textual) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Property Plant And Equipment [Line Items] | ||||
Loss on disposal of property and equipment | $ 0 | $ 0 | $ 108,000 | $ 0 |
Impairment charges | 1,487,000 | |||
Partially constructed device manufacturing machine, abandoned cost | 1,487,000 | 1,487,000 | ||
Depreciation | 0 | 0 | ||
Research and Development [Member] | ||||
Property Plant And Equipment [Line Items] | ||||
Impairment charges | $ 1,487,000 | $ 0 | $ 1,487,000 | $ 0 |
Note 7 - Commitments and Cont41
Note 7 - Commitments and Contingencies (Details Textual) | Aug. 08, 2018USD ($) | Jun. 28, 2018USD ($) | Jun. 01, 2018USD ($) | Oct. 31, 2017USD ($) | Oct. 20, 2017USD ($) | Oct. 01, 2017USD ($) | Jul. 12, 2017USD ($) | Apr. 06, 2017USD ($) | Mar. 01, 2016 | Nov. 01, 2015USD ($) | Jun. 23, 2015USD ($) | Oct. 30, 2015 | Apr. 30, 2015 | Jun. 30, 2018USD ($)Device | Jun. 30, 2017USD ($) | Mar. 31, 2017USD ($) | Jun. 30, 2018USD ($)Device | Jun. 30, 2017USD ($) | Sep. 30, 2017USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2015USD ($) | May 01, 2018USD ($) | Apr. 30, 2018USD ($) | Apr. 13, 2018Lawsuit |
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||||
Income Tax benefit | $ 126,000 | $ (1,654,000) | $ 297,000 | $ (6,980,000) | ||||||||||||||||||||||
Purchase Obligation | 12,370,000 | 12,370,000 | ||||||||||||||||||||||||
Renaissance [Member] | ||||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||||
Purchase Obligation | $ 7,000,000 | $ 12,000,000 | ||||||||||||||||||||||||
Contractual Obligation | 4,870,000 | $ 4,870,000 | ||||||||||||||||||||||||
Extended period of agreement | 2,020 | |||||||||||||||||||||||||
Renaissance [Member] | Scenario Forecast [Member] | ||||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||||
Purchase Obligation Per Calendar Year | $ 2,000,000 | $ 2,000,000 | $ 3,000,000 | |||||||||||||||||||||||
Renaissance [Member] | Loss on Long-term Purchase Commitment [Member] | Cost of Revenue [Member] | ||||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||||
Loss on purchase commitments | $ 1,195,000 | |||||||||||||||||||||||||
Aptargroup, Inc [Member] | ||||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||||
Join agreement period | 7 years | |||||||||||||||||||||||||
Purchase Obligation | $ 9,000,000 | $ 20,790,000 | ||||||||||||||||||||||||
Minimum devices to be purchased to evade annual flat fee | Device | 1,000,000 | 1,000,000 | ||||||||||||||||||||||||
Contractual Obligation | $ 7,500,000 | $ 7,500,000 | ||||||||||||||||||||||||
Maximum [Member] | Aptargroup, Inc [Member] | ||||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||||
Tiered royalties as percentage of net revenue | 1.00% | |||||||||||||||||||||||||
Purchase Obligation Per Calendar Year | $ 500,000 | |||||||||||||||||||||||||
U S Department Of Justice [Member] | ||||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||||
Number of lawsuits declined to intervene in part | Lawsuit | 5 | |||||||||||||||||||||||||
Litigation settlement payment period | 5 years | 5 years | ||||||||||||||||||||||||
U S Department Of Justice [Member] | Subsequent Event [Member] | ||||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||||
Income Tax benefit | $ 0 | |||||||||||||||||||||||||
U S Department Of Justice [Member] | Maximum [Member] | ||||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||||
Estimated Contingent Liability | $ 150,000,000 | $ 150,000,000 | $ 150,000,000 | |||||||||||||||||||||||
U S Department Of Justice [Member] | Maximum [Member] | Subsequent Event [Member] | ||||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||||
Loss Contingency, Estimate of Possible Loss | 75,000,000 | |||||||||||||||||||||||||
U S Department Of Justice [Member] | Minimum [Member] | Subsequent Event [Member] | ||||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||||
Loss Contingency, Estimate of Possible Loss | $ 0 | |||||||||||||||||||||||||
Anti-Kickback Statute Litigation [Member] | Settled Litigation [Member] | ||||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||||
Payments In Question | $ 83,000 | |||||||||||||||||||||||||
Anti-Kickback Statute Litigation [Member] | Minimum [Member] | Settled Litigation [Member] | ||||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||||
Payments In Question | $ 103,000 | |||||||||||||||||||||||||
Kickbacks [Member] | Settled Litigation [Member] | ||||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||||
Payments In Question | $ 188,000 | |||||||||||||||||||||||||
Oregon Department of Justice [Member] | Settled Litigation [Member] | ||||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||||
Litigation Settlement, Amount | $ 1,100,000 | |||||||||||||||||||||||||
State of Illinois [Member] | Settled Litigation [Member] | ||||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||||
Litigation Settlement, Amount | $ 4,450,000 | |||||||||||||||||||||||||
State of New Hampshire [Member] | ||||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||||
Charitable Contribution | 500,000 | |||||||||||||||||||||||||
State of New Hampshire [Member] | Settled Litigation [Member] | ||||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||||
Litigation Settlement, Amount | $ 2,900,000 | |||||||||||||||||||||||||
State of Massachusetts [Member] | Settled Litigation [Member] | ||||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||||
Litigation Settlement, Amount | $ 500,000 | |||||||||||||||||||||||||
Kottayil vs. Insys Pharma, Inc. [Member] | Threatened Litigation [Member] | ||||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||||
Loss Contingency, Damages Sought, Description | On or around November 1, 2015, we received a notice from Dr. Kottayil’s attorneys demanding indemnification for legal and other defense costs alleged to have been incurred in connection with Dr. Kottayil’s defense of the Insys Pharma counterclaims in the amount of $3,630,000. We responded to these demands by, among other things, requesting supporting documents and information from the plaintiffs’ counsel, which we have not received. On June 1, 2018, Dr. Kottayil filed a complaint in Superior Court in the State of Arizona in and for the County of Maricopa against Insys Pharma, Inc., our wholly owned subsidiary. The complaint seeks indemnification in the amount of $3,630,000, plus interest. | |||||||||||||||||||||||||
Loss Contingency, Damages Sought, Value | $ 3,630,000 | $ 3,630,000 | ||||||||||||||||||||||||
Kottayil vs. Insys Pharma, Inc. [Member] | Maximum [Member] | Threatened Litigation [Member] | ||||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||||
Loss Contingency, Estimate of Possible Loss | 3,630,000 | |||||||||||||||||||||||||
Kottayil vs. Insys Pharma, Inc. [Member] | Minimum [Member] | Threatened Litigation [Member] | ||||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||||
Loss Contingency, Estimate of Possible Loss | $ 0 | |||||||||||||||||||||||||
Anthem Blue Cross of California Vs Insys Therapeutics Inc [Member] | Minimum [Member] | ||||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||||
Loss Contingency, Damages Sought, Value | $ 19,000,000 | |||||||||||||||||||||||||
Horizon Blue Cross Blue Shield of New Jersey [Member] | ||||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||||
Loss Contingency, Damages Sought, Value | $ 4,400,000 |
Note 7 - Commitments and Cont42
Note 7 - Commitments and Contingencies - Summary of Aggregate Minimum Purchase Commitments and Exclusive Supply Rights (Details) $ in Thousands | Jun. 30, 2018USD ($) |
Years ending December 31, | |
Remainder of 2018 | $ 2,370 |
2,019 | 4,000 |
2,020 | 4,000 |
2,021 | 2,000 |
Total | $ 12,370 |
Note 8 - Stock-based Compensa43
Note 8 - Stock-based Compensation - Amounts Recognized in Condensed Consolidated Statements of Operations and Comprehensive Loss with Respect to Stock-Based Compensation Plans (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total cost of stock-based compensation | $ 3,384 | $ 4,288 | $ 6,554 | $ 8,280 |
Research and Development Expense [Member] | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total cost of stock-based compensation | 736 | 784 | 1,583 | 1,817 |
General and Administrative Expense [Member] | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total cost of stock-based compensation | $ 2,648 | $ 3,504 | $ 4,971 | $ 6,463 |
Note 8 - Stock-based Compensa44
Note 8 - Stock-based Compensation - Summary of Stock Option Activity (Detail) $ / shares in Units, $ in Millions | 6 Months Ended |
Jun. 30, 2018USD ($)$ / sharesshares | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Number of Shares, Vested and exercisable, Beginning balance | shares | 3,499,957 |
Number of Shares, Outstanding, Beginning balance | shares | 6,332,415 |
Number of Shares, Granted | shares | 1,305,700 |
Number of Shares, Cancelled | shares | (605,506) |
Number of Shares, Exercised | shares | (409,129) |
Number of Shares, Outstanding, Ending balance | shares | 6,623,480 |
Number of Shares, Vested and exercisable, Ending balance | shares | 3,412,459 |
Weighted Average Exercise Price, Vested and exercisable, Beginning balance | $ / shares | $ 11.43 |
Weighted Average Exercise Price, Outstanding, Beginning balance | $ / shares | 12.10 |
Weighted Average Exercise Price, Granted | $ / shares | 7.88 |
Weighted Average Exercise Price, Cancelled | $ / shares | 14.03 |
Weighted Average Exercise Price, Exercised | $ / shares | 2.30 |
Weighted Average Exercise Price, Outstanding, Ending balance | $ / shares | 11.69 |
Weighted Average Exercise Price, Vested and exercisable, Ending balance | $ / shares | $ 12.47 |
Weighted Average Remaining Contractual Term, Outstanding as of June 30, 2018 | 7 years 7 months 6 days |
Weighted Average Remaining Contractual Term, Vested and exercisable as of June 30, 2018 | 6 years 3 months 18 days |
Aggregate Intrinsic Value, Outstanding as of June 30, 2018 | $ | $ 5.5 |
Aggregate Intrinsic Value, Vested and exercisable as of June 30, 2018 | $ | $ 4.8 |
Note 8 - Stock-based Compensa45
Note 8 - Stock-based Compensation (Details Textual) - USD ($) | 6 Months Ended | |
Jun. 30, 2018 | Jun. 30, 2017 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Stock Options | $ 20,394,000 | |
Proceeds from Stock Options Exercised | 916,000 | $ 2,331,000 |
Employee Service Share-based Compensation, Tax Benefit from Compensation Expense | $ 2,210,000 | $ 108,000 |
Stock Options [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 2 years 7 months 6 days | |
Restricted Stock Units [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 2 years | |
Employee service share-based compensation, nonvested awards, compensation not yet recognized | $ 3,925,000 |
Note 8 - Stock-based Compensa46
Note 8 - Stock-based Compensation - Summary of Restricted Stock Unit Activity (Detail) - Restricted Stock Units [Member] | 6 Months Ended |
Jun. 30, 2018$ / sharesshares | |
Number of Shares [Abstract] | |
Number of Units, Outstanding, Beginning balance | shares | 381,900 |
Number of Units, Granted | shares | 283,770 |
Number of units, Exercised | shares | (53,910) |
Number of Units, Cancelled | shares | (35,637) |
Number of Units, Outstanding, Ending balance | shares | 576,123 |
Weighted Average Grant Date Fair Value Per Unit [Abstract] | |
Weighted Average Grant-Date Fair Value Per Unit, Outstanding, Beginning balance | $ / shares | $ 10.27 |
Weighted Average Grant-Date Fair Value Per Unit, Granted | $ / shares | 8.04 |
Weighted Average Grant-Date Fair Value Per Unit, Exercised | $ / shares | 12.65 |
Weighted Average Grant-Date Fair Value Per Unit, Cancelled | $ / shares | 8.86 |
Weighted Average Grant-Date Fair Value Per Unit, Outstanding, Ending balance | $ / shares | $ 9.04 |
Note 9 - Net Loss Per Share - C
Note 9 - Net Loss Per Share - Computation of Basic and Diluted Net Loss Per Common Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Historical net loss per share - Basic | ||||
Net loss | $ (27,350) | $ (8,184) | $ (47,720) | $ (14,708) |
Weighted average number of common shares outstanding | 73,920,645 | 72,169,361 | 73,832,924 | 72,057,552 |
Basic net loss per common share | $ (0.37) | $ (0.11) | $ (0.65) | $ (0.20) |
Historical net loss per share - Diluted | ||||
Net loss | $ (27,350) | $ (8,184) | $ (47,720) | $ (14,708) |
Weighted average number of common shares outstanding | 73,920,645 | 72,169,361 | 73,832,924 | 72,057,552 |
Weighted average number of common shares outstanding | 73,920,645 | 72,169,361 | 73,832,924 | 72,057,552 |
Diluted net loss per common share | $ (0.37) | $ (0.11) | $ (0.65) | $ (0.20) |
Note 9 - Net Loss Per Share (De
Note 9 - Net Loss Per Share (Details Textual) - shares | 6 Months Ended | |
Jun. 30, 2018 | Jun. 30, 2017 | |
Earnings Per Share [Abstract] | ||
Anti-dilutive securities excluded from computation of earnings per share, Shares | 5,632,270 | 5,559,590 |
Note 10 - Product Lines, Conc49
Note 10 - Product Lines, Concentration of Credit Risk and Significant Customers (Details Textual) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2018ProductLine | Jun. 30, 2018ProductLineWholesaler | Jun. 30, 2017Wholesaler | Dec. 31, 2017Wholesaler | |
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | ||||
Number of Product Lines | ProductLine | 2 | 2 | ||
Customer Concentration Risk [Member] | Sales Revenue Net [Member] | Pharmaceutical Wholesaler Customer One [Member] | ||||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | ||||
Concentration Risk, Percentage | 31.00% | 24.00% | ||
Customer Concentration Risk [Member] | Sales Revenue Net [Member] | Pharmaceutical Wholesaler Customer Two [Member] | ||||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | ||||
Concentration Risk, Percentage | 15.00% | 18.00% | ||
Customer Concentration Risk [Member] | Sales Revenue Net [Member] | Pharmaceutical Wholesaler Customer Three [Member] | ||||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | ||||
Concentration Risk, Percentage | 11.00% | 11.00% | ||
Customer Concentration Risk [Member] | Sales Revenue Net [Member] | Pharmaceutical Wholesalers [Member] | ||||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | ||||
Concentration Risk, Number of Customers | 3 | 3 | ||
Customer Concentration Risk [Member] | Sales Revenue Net [Member] | Specialty Pharmaceutical Retailers Customer One [Member] | ||||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | ||||
Concentration Risk, Percentage | 22.00% | 27.00% | ||
Customer Concentration Risk [Member] | Sales Revenue Net [Member] | Specialty Pharmaceutical Retailers Customer Two [Member] | ||||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | ||||
Concentration Risk, Percentage | 17.00% | 11.00% | ||
Customer Concentration Risk [Member] | Sales Revenue Net [Member] | Specialty Pharmaceutical Retailers [Member] | ||||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | ||||
Concentration Risk, Number of Customers | 2 | 2 | ||
Customer Concentration Risk [Member] | Accounts Receivable [Member] | Pharmaceutical Wholesaler Customer One [Member] | ||||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | ||||
Concentration Risk, Percentage | 43.00% | 44.00% | ||
Customer Concentration Risk [Member] | Accounts Receivable [Member] | Pharmaceutical Wholesaler Customer Two [Member] | ||||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | ||||
Concentration Risk, Percentage | 12.00% | 18.00% | ||
Customer Concentration Risk [Member] | Accounts Receivable [Member] | Pharmaceutical Wholesaler Customer Three [Member] | ||||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | ||||
Concentration Risk, Percentage | 11.00% | 10.00% | ||
Customer Concentration Risk [Member] | Accounts Receivable [Member] | Pharmaceutical Wholesalers [Member] | ||||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | ||||
Concentration Risk, Number of Customers | 3 | 3 | ||
Customer Concentration Risk [Member] | Accounts Receivable [Member] | Specialty Pharmaceutical Retailers Customer One [Member] | ||||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | ||||
Concentration Risk, Percentage | 22.00% | 13.00% | ||
Customer Concentration Risk [Member] | Accounts Receivable [Member] | Specialty Pharmaceutical Retailers Customer Two [Member] | ||||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | ||||
Concentration Risk, Percentage | 15.00% | 12.00% | ||
Customer Concentration Risk [Member] | Accounts Receivable [Member] | Specialty Pharmaceutical Retailers [Member] | ||||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | ||||
Concentration Risk, Number of Customers | 2 | 2 |
Note 10 - Product Lines, Conc50
Note 10 - Product Lines, Concentration of Credit Risk and Significant Customers - Summary of Net Revenue by Product Line and Percentages (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Segment Reporting Information [Line Items] | ||||
Revenues | $ 23,466 | $ 42,576 | $ 47,377 | $ 78,538 |
SUBSYS [Member] | ||||
Segment Reporting Information [Line Items] | ||||
Revenues | 22,470 | $ 42,576 | 45,744 | $ 78,538 |
SYNDROS [Member] | ||||
Segment Reporting Information [Line Items] | ||||
Revenues | $ 996 | $ 1,633 |
Note 10 - Product Lines, Conc51
Note 10 - Product Lines, Concentration of Credit Risk and Significant Customers - Percentage of Revenue by Route to Market (Details) - Sales Revenue, Product Line [Member] - Customer Concentration Risk [Member] | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Segment Reporting Information [Line Items] | ||||
Concentration Risk Percentage | 100.00% | 100.00% | 100.00% | 100.00% |
Pharmaceutical Wholesalers [Member] | ||||
Segment Reporting Information [Line Items] | ||||
Concentration Risk Percentage | 59.00% | 59.00% | 60.00% | 62.00% |
Specialty Pharmaceutical Retailers [Member] | ||||
Segment Reporting Information [Line Items] | ||||
Concentration Risk Percentage | 41.00% | 41.00% | 40.00% | 38.00% |