Document And Entity Information
Document And Entity Information - shares | 3 Months Ended | |
Mar. 31, 2017 | May 02, 2017 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2017 | |
Document Fiscal Year Focus | 2,017 | |
Document Fiscal Period Focus | Q1 | |
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) | 72,125,321 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($) $ in Thousands | Mar. 31, 2017 | Dec. 31, 2016 |
Current Assets: | ||
Cash and cash equivalents | $ 68,373 | $ 104,642 |
Short-term investments | 86,914 | 78,238 |
Accounts receivable, net of allowances of $4,105 and $6,144 at March 31, 2017 and December 31, 2016, respectively | 13,313 | 20,654 |
Inventories, net | 21,288 | 20,414 |
Prepaid expenses and other current assets | 7,048 | 5,695 |
Total current assets | 196,936 | 229,643 |
Property and equipment, net | 46,009 | 43,172 |
Long-term investments | 63,193 | 53,796 |
Deferred income tax assets, net | 27,708 | 23,243 |
Other assets | 3,750 | 6,282 |
Total assets | 337,596 | 356,136 |
Current Liabilities: | ||
Accounts payable and accrued expenses | 28,205 | 27,359 |
Accrued compensation | 4,236 | 8,833 |
Accrued sales allowances | 19,352 | 28,955 |
Accrued litigation award and settlements | 10,067 | 13,467 |
Total current liabilities | 61,860 | 78,614 |
Uncertain income tax position | 7,950 | 7,933 |
Total liabilities | 69,810 | 86,547 |
Commitments and contingencies (Note 6) | ||
Stockholders' Equity: | ||
Preferred stock (par value $0.01 per share; 10,000,000 shares authorized; 0 shares issued and outstanding as of March 31, 2017 and December 31, 2016, respectively) | 0 | 0 |
Common stock (par value $0.01 per share; 100,000,000 shares authorized; 72,114,799 and 71,923,550 shares issued and outstanding as of March 31, 2017 and December 31, 2016, respectively) | 721 | 719 |
Additional paid in capital | 261,173 | 256,529 |
Unrealized loss on available-for-sale securities, net of tax | (227) | (302) |
Notes receivable from stockholders | (21) | (21) |
Retained earnings | 6,140 | 12,664 |
Total stockholders' equity | 267,786 | 269,589 |
Total liabilities and stockholders' equity | $ 337,596 | $ 356,136 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - USD ($) $ in Thousands | Mar. 31, 2017 | Dec. 31, 2016 |
Statement Of Financial Position [Abstract] | ||
Accounts receivable, allowance for doubtful accounts | $ 4,105 | $ 6,144 |
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
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) | 72,114,799 | 71,923,550 |
Common stock, shares outstanding (in shares) | 72,114,799 | 71,923,550 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Income Statement [Abstract] | ||
Net revenue | $ 35,962 | $ 60,421 |
Cost of revenue | 4,639 | 4,638 |
Gross profit | 31,323 | 55,783 |
Operating expenses: | ||
Sales and marketing | 15,658 | 19,800 |
Research and development | 12,934 | 19,035 |
General and administrative | 15,042 | 14,698 |
Total operating expenses | 43,634 | 53,533 |
Operating income (loss) | (12,311) | 2,250 |
Other income: | ||
Interest income | 435 | 225 |
Other income, net | 26 | 49 |
Total other income | 461 | 274 |
Income (loss) before income taxes | (11,850) | 2,524 |
Income tax expense (benefit) | (5,326) | 234 |
Net income (loss) | (6,524) | 2,290 |
Unrealized gain on available-for-sale securities, net of tax | 75 | 166 |
Total comprehensive income (loss) | $ (6,449) | $ 2,456 |
Net income (loss) per common share: | ||
Basic | $ (0.09) | $ 0.03 |
Diluted | $ (0.09) | $ 0.03 |
Weighted average common shares outstanding | ||
Basic | 71,945,743 | 71,592,089 |
Diluted | 71,945,743 | 74,462,878 |
Condensed Consolidated Stateme5
Condensed Consolidated Statement of Stockholders' Equity - 3 months ended Mar. 31, 2017 - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid in Capital [Member] | Unrealized Gain (Loss) on Available-For-Sale Securities [Member] | Notes Receivable From Stockholders [Member] | Retained Earnings [Member] |
Balance (in shares) at Dec. 31, 2016 | 71,923,550 | |||||
Balance at Dec. 31, 2016 | $ 269,589 | $ 719 | $ 256,529 | $ (302) | $ (21) | $ 12,664 |
Exercise of stock options (in shares) | 191,249 | 191,249 | ||||
Exercise of stock options | $ 654 | $ 2 | 652 | |||
Stock based compensation - stock options and awards | 3,992 | 3,992 | ||||
Unrealized gain on available-for-sale securities, net of tax | 75 | 75 | ||||
Net loss | (6,524) | (6,524) | ||||
Balance (in shares) at Mar. 31, 2017 | 72,114,799 | |||||
Balance at Mar. 31, 2017 | $ 267,786 | $ 721 | $ 261,173 | $ (227) | $ (21) | $ 6,140 |
Condensed Consolidated Stateme6
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Cash flows from operating activities: | ||
Net income (loss) | $ (6,524) | $ 2,290 |
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: | ||
Depreciation and amortization | 1,774 | 1,527 |
Stock-based compensation | 3,992 | 4,126 |
Deferred income tax benefit | (4,465) | (585) |
Excess tax benefits on stock options and awards | (653) | |
Amortization of investment discount | 347 | 569 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 7,341 | 26,609 |
Inventories | 1,658 | (1,665) |
Prepaid expenses and other current assets | (1,353) | (104) |
Accounts payable, accrued expenses and other current liabilities | (16,039) | (19,939) |
Accrued litigation award and settlements | (3,400) | |
Net cash provided by (used in) operating activities | (16,669) | 12,175 |
Cash flows from investing activities: | ||
Purchase of investments | (46,510) | (22,574) |
Proceeds from sales of investments | 1,620 | 2,108 |
Proceeds from maturities of investments | 26,545 | 16,607 |
Purchases of property and equipment | (1,909) | (2,623) |
Net cash used in investing activities | (20,254) | (6,482) |
Cash flows from financing activities: | ||
Excess tax benefits on stock options and awards | 653 | |
Proceeds from exercise of stock options | 654 | 1,310 |
Repurchase of common stock | (13,351) | |
Net cash provided by (used in) financing activities | 654 | (11,388) |
Change in cash and cash equivalents | (36,269) | (5,695) |
Cash and cash equivalents, beginning of period | 104,642 | 79,515 |
Cash and cash equivalents, end of period | 68,373 | 73,820 |
Supplemental cash flow disclosures: | ||
Cash paid for income taxes | 14 | |
Non-cash capital expenditures | $ 2,702 | $ 140 |
Note 1 - Nature of Business and
Note 1 - Nature of Business and Basis of Presentation | 3 Months Ended |
Mar. 31, 2017 | |
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. We have one marketed product: SUBSYS®, a proprietary sublingual fentanyl spray for BTCP in opioid-tolerant adult patients; and one product: SYNDROS™, awaiting final labeling approval by the FDA, prior to commercial launch, after receiving FDA approval in July 2016 and DEA scheduling in March 2017. 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, 2016, included in our Annual Report on Form 10-K. The results of operations for the three months ended March 31, 2017 and 2016 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, liabilities, revenues, expenses, and related disclosure of contingent assets and liabilities. On an on-going basis, we evaluate our estimates, including those related to revenue recognition (which is affected by prescriptions dispensed, wholesaler discounts, patient discount programs, rebates, and chargebacks), inventories, stock-based compensation expense, 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 may 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, 2017, we adopted ASU No. 2016-09, Compensation-Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting. Among other requirements, the new guidance requires all tax effects related to share-based payments at settlement (or expiration) to be recorded through the income statement. Previously, tax benefits in excess of compensation cost ("windfalls") were recorded in equity, and tax deficiencies ("shortfalls") were recorded in equity to the extent of previous windfalls, and then to the income statement. As required, this change was applied prospectively to all excess tax benefits and tax deficiencies resulting from settlements. Under the new guidance, the windfall tax benefit is to be recorded when it arises, subject to normal valuation allowance considerations. Excess tax benefits that were not previously recognized because the related tax deduction had not reduced current taxes payable were recorded through a cumulative effect adjustment as of the date of the adoption. As required, this change was applied on a modified retrospective basis, with a cumulative effect adjustment of change in accounting principle of approximately $368,000 as a deferred tax asset with a corresponding valuation allowance of $368,000, which were offset in retained earnings. Additionally, our condensed consolidated statement of cash flows now presents excess tax benefits as an operating activity, adjusted prospectively with no adjustments made to prior periods. Additionally, ASU No. 2016-09 addressed the presentation of employee taxes paid on the statement of cash flows. We are now required to present the cost of shares withheld from the employee to satisfy the employees’ income tax liability as a financing activity on the statement of cash flows rather than as an operating cash flow. This change was applied on a retrospective basis, as required, but did not impact the condensed consolidated statement of cash flows for the three months ended March 31, 2016. ASU 2016-09 also permits entities to make an accounting policy election related to how forfeitures will impact the recognition of compensation cost for stock-based compensation to either estimate the total number of awards for which the requisite service period will not be rendered, as currently required, or to account for forfeitures as they occur. Upon adoption of ASU 2016-09, we elected to change our accounting policy to account for forfeitures as they occur. As required, this change was applied on a modified retrospective basis; however, as of December 31, 2016, we had estimated no forfeitures relating to the outstanding equity awards. As a result, no adjustment was required. Going forward, the adoption of ASU 2016-09 could cause volatility in the effective tax rate, as the excess tax benefits associated with the exercise of stock options could generate a significant discrete income tax benefit in a particular interim period, potentially creating volatility in net income and net income per share period-to-period and period-over-period. Effective January 1, 2017, we adopted ASU No. 2015-11, Inventory (Topic 330): Simplifying the Measurement of Inventory. Prior to January 1, 2017, we measured inventory at the lower of cost or market. This guidance requires us to measure inventory at the lower of cost and NRV, which eliminates the need to determine replacement cost and evaluate whether it is above the ceiling (NRV) or below the floor (NRV less a normal profit margin). The guidance defines NRV as the “estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation.” The adoption of this guidance did not have a material impact on our condensed consolidated financial statements. 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 consolidated financial statements. In October 2016, the FASB issued ASU No. 2016-16, Income Taxes (Topic 740): Intra-Entity Transfers of Assets Other Than Inventory, to improve the accounting for the income tax consequences of intra-entity transfers of assets other than inventory. Current U. S. GAAP prohibits the recognition of current and deferred income taxes for an intra-entity asset transfer until the asset has been sold to an outside party, which is an exception to the principle of comprehensive recognition of current and deferred income taxes in U. S. GAAP. The amendments in this update eliminate the exception for an intra-entity transfer of an asset other than inventory. The amendments should be applied on a modified retrospective transition basis, and are effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years, and early adoption is permitted. We are currently evaluating the impact of these amendments on our consolidated financial statements. In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments. The amendments effected by this ASU affect entities required to present a statement of cash flows and provide specific guidance on a variety of cash flow issues to reduce current and potential future diversity in practice. The amendments are effective for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years, and early adoption is permitted. An entity that elects early adoption must adopt all of the amendments in the same period. The amendments should be applied using a retrospective transition method to each period presented. We are currently evaluating the impact of these amendments on our 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 are currently evaluating the impact of these amendments on our 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 are currently evaluating the impact of these amendments on our consolidated financial statements and related disclosures; however, based on our current operating leases, we do not expect that the adoption of this guidance will have a material impact on the consolidated financial statements. See Note 6, Commitments and Contingencies, In January 2016, the FASB issued ASU No. 2016-01, Financial Instruments—Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities, which amended the Financial Instruments topic of the ASC to address certain aspects of recognition, measurement, presentation, and disclosure of financial instruments. The amendments will be effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years, and early adoption is not permitted. These amendments should be applied by means of a cumulative-effect adjustment to the balance sheet as of the beginning of the fiscal year of adoption. The amendments related to equity securities without readily determinable fair values (including disclosure requirements) should be applied prospectively to equity investments that exist as of the date of adoption. We are currently evaluating the impact of these amendments on our consolidated financial statements In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606). The new 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 standard requires that reporting companies disclose the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers. The new standard is required to be applied either retrospectively to each prior reporting period presented or retrospectively with the cumulative effect of initially applying it recognized at the date of initial application. In March 2016 and April 2016, the FASB issued ASU No. 2016-08 and ASU No. 2016-10, respectively, which further clarified the implementation guidance on principal versus agent considerations contained in ASU No. 2014-09 and the identification of performance obligations and licensing, respectively. In May 2016, the FASB issued ASU 2016-12, Narrow-Scope Improvements and Practical Expedients, which provides clarification on assessing the collectability criterion, presentation of sales taxes, measurement date for non-cash consideration and completed contracts at transition. These standards will be effective for annual periods beginning after December 15, 2017, and interim periods therein, using either of the following transition methods: (i) a full retrospective approach reflecting the application of the standard in each prior reporting period with the option to elect certain practical expedients, or (ii) a retrospective approach with the cumulative effect of initially adopting ASU 2014-09 recognized at the date of adoption (which includes additional footnote disclosures). Early adoption is permitted, but not before December 15, 2016, the original effective date of the standard. We are currently analyzing ASU 2014-09, and the related ASUs, to evaluate the impact of the new standard on existing contracts with our customers. This includes reviewing current accounting policies and practices to identify potential differences that would result from applying the requirements under the new standard. We initiated a contract review process during 2016 and expect to complete the contract evaluations and validate results by the end of the second quarter of 2017. We have also started evaluating our existing accounting policies and the new disclosure requirements and expect to complete our evaluation of the impacts of the accounting and disclosure requirements on our business processes, controls and systems by the end of the second quarter of 2017. Additionally, we will continue to monitor industry activities and any additional guidance provided by regulators, standards setters, or the accounting profession and adjust our assessment and implementation plans accordingly. Full implementation will be completed by the end of 2017. We have not yet determined our selected method of transition. |
Note 2 - Revenue Recognition
Note 2 - Revenue Recognition | 3 Months Ended |
Mar. 31, 2017 | |
Revenue Recognition [Abstract] | |
Revenue Recognition | 2. Revenue Recognition We recognize revenue from the sale of SUBSYS®. Revenue is recognized when (i) persuasive evidence of an arrangement exists, (ii) delivery has occurred and title has passed, (iii) the price is fixed or determinable and (iv) collectability is reasonably assured. SUBSYS® was commercially launched in March 2012 and is monitored by an FDA-mandated REMS program known as the TIRF REMS. We sell SUBSYS® in the United States to wholesale pharmaceutical distributors and directly to retail pharmacies, collectively our customers, subject to rights of return within a period beginning six months prior to, and ending 12 months following, product expiration. SUBSYS® currently has a shelf life of 36 months from the date of manufacture. We record revenue for SUBSYS® at the time the customer receives the shipment. We recognize estimated product sales allowances as a reduction of product sales in the same period the related revenue is recognized. Product sales allowances are based on amounts owed or to be claimed on the related sales. These estimates 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, we recognize the cost of patient discounts as a reduction of revenue based on estimated utilization. If actual future results vary, we may need to adjust these estimates, which could have an effect on product 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. The shelf life of SUBSYS® is currently 36 months from the date of manufacture. 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 after, 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 product. Accordingly, we may have to adjust these estimates, which could have an effect on product sales 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 upon shipment to the respective wholesale distributors and retail pharmacies. Patient Discount Programs . We offer discount card programs to patients for SUBSYS®, 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 redemption applied to inventory in the distribution and retail channel. 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 sold 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 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. |
Note 3 - Short-term and Long-te
Note 3 - Short-term and Long-term Investments | 3 Months Ended |
Mar. 31, 2017 | |
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 No. 320, Investments — Debt and Equity Securities. Available-for-sale securities 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 months ended March 31, 2017 and 2016. 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. We did not have any unrealized gains or losses or decline in values judged to be other than temporary during the three months ended March 31, 2017 and 2016. 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 income (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 March 31, 2017, our certificates of deposit and commercial paper as well as our marketable securities have been recorded at an estimated fair value of $5,009,000, $86,914,000, and $63,193,000 in cash and cash equivalents, short-term and long-term investments, respectively. Investments consisted of the following at March 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 $ 28,562 $ — $ — $ — $ 28,562 $ 28,562 $ — $ — Money market securities 34,802 — — — 34,802 34,802 — — Marketable securities: Certificates of deposit 25,919 — — — 25,919 — 14,055 11,864 Commercial paper 11,963 — — — 11,963 4,497 7,466 — Corporate securities 53,815 6 (120 ) — 53,701 — 34,371 19,330 Federal agency securities 33,320 3 (94 ) — 33,229 — 10,502 22,727 Municipal securities 30,326 6 (28 ) — 30,304 512 20,520 9,272 Total marketable securities 155,343 15 (242 ) — 155,116 5,009 86,914 63,193 $ 218,707 $ 15 $ (242 ) $ — $ 218,480 $ 68,373 $ 86,914 $ 63,193 Investments consisted of the following at December 31, 2016 (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 $ 49,331 $ — $ — $ — $ 49,331 $ 49,331 $ — $ — Money market securities 54,015 — — — 54,015 54,015 — — Marketable securities: Certificates of deposit 26,114 — — — 26,114 — 13,855 12,259 Commercial paper 1,485 — — — 1,485 — 1,485 — Corporate securities 39,562 — (135 ) — 39,427 500 25,681 13,246 Federal agency securities 30,660 4 (92 ) — 30,572 — 10,854 19,718 Municipal securities 35,811 2 (81 ) — 35,732 796 26,363 8,573 Total marketable securities 133,632 6 (308 ) — 133,330 1,296 78,238 53,796 $ 236,978 $ 6 $ (308 ) $ — $ 236,676 $ 104,642 $ 78,238 $ 53,796 The amortized cost and estimated fair value of the marketable securities by maturity, are shown below (in thousands): March 31, 2017 December 31, 2016 Amortized Cost Fair Value Amortized Cost Fair Value Marketable securities: Due in one year or less $ 93,976 $ 93,924 $ 80,092 $ 80,027 Due after one year through 5 years 61,367 61,192 53,540 53,303 Due after 5 years through 10 years — — — — Due after 10 years — — — — $ 155,343 $ 155,116 $ 133,632 $ 133,330 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): March 31, 2017 December 31, 2016 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 $ 48,277 $ (120 ) $ — $ — $ 38,027 $ (134 ) $ 401 $ (1 ) Federal agency securities 26,878 (93 ) 1,205 (1 ) 26,449 (91 ) 1,217 (1 ) Municipal securities 16,870 (28 ) — — 30,373 (81 ) 100 — $ 92,025 $ (241 ) $ 1,205 $ (1 ) $ 94,849 $ (306 ) $ 1,718 $ (2 ) As of March 31, 2017 and 2016, we have concluded that all the unrealized losses on our marketable securities are temporary in nature. Marketable securities are reviewed quarterly for possible other-than-temporary impairment. 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. Additionally, we do not intend to sell, and it is not probable that we will be required to sell, any of the securities before the recovery of their amortized cost basis. |
Note 4 - Fair Value Measurement
Note 4 - Fair Value Measurement | 3 Months Ended |
Mar. 31, 2017 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurement | 4. Fair Value Measurement FASB ASC No. 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 March 31, 2017 and December 31, 2016, 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. All available-for-sale investments held by us at March 31, 2017 and December 31, 2016 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 our investment in a long-term corporate convertible promissory note and a warrant to purchase shares issued in connection with the convertible promissory note, which converted to convertible preferred stock on December 30, 2016. This stock is not listed on any security exchange. The fair value of the preferred stock approximates its carrying value at March 31, 2017 and December 31, 2016. Our investments measured at fair value on a recurring basis subject to the disclosure requirements of ASC 820 at March 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) Marketable securities: Certificates of deposit $ 25,919 $ — $ 25,919 $ — Commercial paper 11,963 — 11,963 — Corporate securities 53,701 — 53,183 518 Federal agency securities 33,229 — 33,229 — Municipal securities 30,304 — 30,304 — Total assets measured at fair value $ 155,116 $ — $ 154,598 $ 518 Our investments measured at fair value on a recurring basis subject to the disclosure requirements of ASC 820 at December 31, 2016 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) Marketable securities: Certificates of deposit $ 26,114 $ — $ 26,114 $ — Commercial paper 1,485 — 1,485 — Corporate securities 39,427 — 38,927 500 Federal agency securities 30,572 — 30,572 — Municipal securities 35,732 — 35,732 — Total assets measured at fair value $ 133,330 $ — $ 132,830 $ 500 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 months ended March 31, 2017 and 2016 (in thousands): Three Months Ended March 31, 2017 2016 Convertible stock Balance, beginning of period $ 500 $ — Change in fair value 18 — Purchases — — Balance, end of period $ 518 $ — |
Note 5 - Inventories, Net
Note 5 - Inventories, Net | 3 Months Ended |
Mar. 31, 2017 | |
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): March 31, December 31, 2017 2016 Finished goods $ 7,105 $ 8,408 Work-in-process 6,760 6,183 Raw materials and supplies 7,423 5,823 Total inventories 21,288 20,414 Plus: non-current raw materials and supplies and finished goods 3,725 6,257 $ 25,013 $ 26,671 As of March 31, 2017 and December 31, 2016, raw materials inventories consisted of raw materials used in the manufacture of the API in our U.S.-based, state-of-the-art dronabinol manufacturing facility and component parts and packaging materials used in the manufacture of SUBSYS®. Work-in-process consists of actual production costs, including facility overhead and tolling costs of in-process dronabinol and SUBSYS® products. Finished goods inventories consisted of finished SUBSYS® products. Non-current raw materials and supplies 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 March 31, 2017, and December 31, 2016, all work-in-process inventory is expected to be used within 12 months of the balance sheet date and, therefore, is classified as current inventory. We maintain an allowance for excess and obsolete inventory, as well as inventory where its cost is in excess of its NRV. Inventories at March 31, 2017 and December 31, 2016 were reported net of these reserves of $8.9 million and $6.8 million, respectively. During the three months ended March 31, 2017, we increased these reserves by $2.1 million. There was no similar expense during the three months ended March 31, 2016. |
Note 6 - Commitments and Contin
Note 6 - Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2017 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 6. 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 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 financial condition, results of operations and cash flows for that future period, 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 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. Department of Health and Human Services 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. This subpoena requests documents regarding our business, including the commercialization of SUBSYS®. We are cooperating with this investigation and have produced documents in response to the subpoena and have provided other requested information. We believe a loss is probable with respect to this investigation, but we are not in a position to estimate a range of such loss or other scope and outcome associated with this investigation. 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 requests 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 are cooperating with this investigation and have produced documents in response to the subpoena and have provided other requested information. We believe a loss is probable with respect to this investigation, but we are not in a position to estimate a range of such loss or other scope and outcome associated with this investigation. 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. Several of our former employees have been charged in criminal proceedings related to our federal investigations. 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 regard to two Alabama health care professionals who prescribed our product SUBSYS®. These two Alabama health care professionals, 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, were charged by the U.S. Attorney’s Office for the Southern District of Alabama, and on or about February 23, 2017, 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. Moreover, 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. Both of these employees have pled not guilty. On or about October 13, 2016, a former prior authorization specialist and manager of our patient services hub was charged by the U.S. Attorney’s Office for the District of Massachusetts with conspiracy to commit wire fraud in connection with our provision of prior authorization support related to our patient services hub. 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. 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. Other than the former Alabama sales employee, each of these indicted individuals have entered pleas of not guilty to the charges against them. It is possible that additional individual criminal charges and convictions and pleas could result from our ongoing federal and state government investigations and related proceedings. We continue to assess these matters to ensure we have an effective compliance program. State Related Investigations . We have received CIDs or subpoenas, as the case may be, from each of the Office of the Attorney General (or similarly named and authorized office) of the State of Arizona, Colorado, Florida, Illinois, Massachusetts, Maryland, Minnesota, New Hampshire, New Jersey, New York, Oregon, Pennsylvania 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 each applicable state Attorney General or Department of Justice office 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 documents in response to these CIDs, subpoenas and related requests for information from each office. 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 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 State of Illinois, on August 25, 2016, the Illinois Office of the Attorney General filed a complaint on behalf of the State of Illinois against us in the Circuit Court of Cook County, Illinois, Chancery Division. The complaint asserts a claim for violation of the Illinois Consumer Fraud and Deceptive Business Practices Act in connection with the sales and marketing of SUBSYS® in Illinois. The complaint seeks injunctive relief, including a permanent injunction preventing us from engaging in commerce in the State of Illinois, and civil penalties. The Circuit Court of Cook County extended the time for us to answer or otherwise respond to the complaint and the next status hearing is May 12, 2017. We continue to cooperate with this investigation and to engage in discussions with the Illinois Office of the Attorney General. 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 sheet 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 have made a reasonable estimate of a probable loss of approximately $500,000. We continue to cooperate with the State of Massachusetts investigation, including producing documents in response to certain requests for information. This estimated amount was accrued in the consolidated balance sheet as of March 31, 2017. Investigations of Physicians . In addition to the above investigations that are specifically directed at us, we have received governmental agency requests for information, including subpoenas, from the USAO of Connecticut, Eastern District of Michigan, Florida (Jacksonville), Kansas, New Hampshire, Rhode Island, Southern District of New York, Southern District of Ohio, Southern District of Alabama, Northern District of Texas and Western District of New York regarding specific physicians that we have interacted with in those states. Opioid Litigation . Many federal and governmental agencies 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. Common prescription drugs that contain opioids are drugs such as oxycodone, hydrocodone and fentanyl. Our product, SUBSYS®, is a fentanyl-based product in the TIRF class. Certain stakeholders in the health care community, regulatory bodies and governmental agencies may associate us with, or determine that we are a part of, this perceived opioid abuse epidemic. Like all TIRF products, our product is part of the mandatory TIRF REMS program, which is designed “to ensure informed risk-benefit decisions before initiating treatment, and while patients are treated to ensure appropriate use of TIRF medicines” and “to mitigate the risk of misuse, abuse, addiction, overdose and serious complications due to medication errors with the use of TIRF medicines.” Nevertheless, from time to time, we may be included in litigation or investigations that are directed at the abuse of opioids in the United States. For example, in May 2014, Santa Clara and Orange Counties in California filed a complaint in state court in Orange County, California against numerous pharmaceutical manufacturers alleging claims related to opioid marketing practices, including false advertising, unfair competition, and public nuisance. Despite the fact that we are not named specifically in the complaint and this lawsuit was recently stayed, we have received a preservation notice letter from the Office of the County Counsel for the County of Santa Clara. From time to time, we may be included in these types of litigations as a result of the fact that we market an opioid product. In addition, 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 requests documents regarding our business, including the commercialization of SUBSYS®. We intend to cooperate with this inquiry. With the exception of the investigations by the ODOJ, the State of New Hampshire and the State of Massachusetts, 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 complaint was brought as a purported class action on behalf of purchasers of our common stock between March 3, 2015 and January 25, 2016. In general, the plaintiffs allege that the defendants violated the anti-fraud provisions of the federal securities laws by making materially false and misleading statements regarding our business, operations and compliance with laws during the class period, thereby artificially inflating the price of our common stock. On June 3, 2016, the court appointed Clark Miller to serve as lead plaintiff. On June 24, 2016, the plaintiff filed a first amended complaint naming a former employee of Insys Therapeutics, Inc. as an additional defendant and extending the class period. On December 22, 2016, the plaintiff filed a second amended complaint, primarily to add allegations relating to an indictment of Michael L. Babich and certain of our former employees announced on December 8, 2016, and to extend the class period from August 12, 2014 through December 8, 2016. On January 12, 2017, the defendants moved to dismiss the second amended complaint. The plaintiff seeks unspecified monetary damages and other relief. We intend to vigorously defend against this claim. On or about March 17, 2017, a complaint (captioned Kayd Currier v. Insys Therapeutics, Inc., et al., Case 1:17-cv-01954-PAC) was filed in United States District Court for the Southern District of New York against us and certain of our officers. The complaint was brought as a purported class action on behalf of purchasers of our securities between February 23, 2016 and March 15, 2017. In general, the plaintiffs allege that the defendants violated the anti-fraud provisions of the federal securities laws by making materially false and misleading statements regarding our business and financial results during the class period, thereby artificially inflating the price of our securities. On or about March 28, 2017, a second complaint making similar allegations (captioned Hans E. Erdmann v. Insys Therapeutics, Inc., et al., Case 1:17-cv-02225-PAC) was filed in the same Court. The plaintiffs in both actions seek unspecified monetary damages and other relief. We intend to vigorously defend against these claims. Derivative Litigation. On or about August 26, 2016, Gary Hirt and Precieux Art Jewelers Inc. filed a derivative complaint in the Court of Chancery of Delaware against members of our Board of Directors and Michael L. Babich. The plaintiffs allege, among other things, that the defendants breached their fiduciary duties by (a) knowingly overseeing the implementation of an illegal sales and marketing program, (b) consciously disregarding their duty of oversight of our compliance with laws and (c) trading on the basis of material non-public information. On November 8, 2016, the plaintiffs filed an amended derivative complaint, and on January 26, 2017, the plaintiffs supplemented the amended derivative complaint, primarily to add allegations relating to the indictment of Michael L. Babich and certain of our former employees announced on December 8, 2016. On November 22, 2016, the defendants moved to dismiss the action. On or about February 2, 2017, Michael Bourque filed a derivative complaint in the Court of Chancery against members of our Board of Directors; Michael L. Babich; Franc Del Fosse, our General Counsel; and Sanga Emmanuel, our Vice President and Chief Compliance Officer. The Bourque derivative complaint contains similar claims as the other derivative complaint. All parties stipulated to consolidate the two actions, and the consolidated action is captioned In re Insys Therapeutics, Inc. Derivative Litigation, C.A. No. 12696-VCMR. Following the submission of motions for appointment as lead counsel, the Court held a hearing on March 23, 2017, and appointed counsel for Gary Hirt and Precieux Art Jewelers Inc. as lead counsel. Lead counsel is required to designate an operative complaint or file a consolidated complaint. The plaintiffs seek unspecified monetary damages and other relief derivatively on behalf of Insys Therapeutics, Inc. We intend to vigorously defend against these claims. General Litigation and Disputes Kottayil vs. Insys Pharma, Inc . On September 29, 2009, Insys Pharma, Inc., our wholly owned subsidiary, and certain of our officers and the five directors who comprised the Insys Pharma board of directors as of June 2009, as well as their spouses, were named as defendants in a lawsuit in the Superior Court of the State of Arizona, Maricopa County, or the Arizona Superior Court, brought by Santosh Kottayil, Ph.D., certain of his family members and a trust of which Dr. Kottayil is the trustee. Dr. Kottayil formerly served as President, Chief Scientific Officer and a director of Insys Pharma, among other positions. The complaint brought a cause of action for statutory and common law appraisal of Dr. Kottayil’s Insys Pharma common stock. The cause of action for appraisal relates to a reverse stock split that Insys Pharma effected in June 2009, which resulted in Dr. Kottayil’s ownership position becoming a fractional share of Insys Pharma common stock. Following the reverse stock split, Insys Pharma cancelled all resulting fractional shares, including the fractional share held by Dr. Kottayil, and offered a cash payment in lieu of the fractional shares. The complaint also brought causes of action for breach of fiduciary duty, fraud and negligent misrepresentation in the defendants’ dealings with Dr. Kottayil on the subject of his compensation and stock ownership in Insys Pharma. In January 2010, the plaintiffs added claims seeking to rescind Dr. Kottayil’s assignment to Insys Pharma of his interest in all of the fentanyl and dronabinol patent applications previously assigned to Insys Pharma and to recover the benefits of those interests. Dr. Kottayil was seeking, among other relief, the fair value of his Insys Pharma common stock as of June 2, 2009, compensatory and punitive damages, and rescission of all assignments to Insys Pharma of his interest in the patent applications, as well as attorneys’ fees, costs and interest. In February 2010, Insys Pharma and the other defendants answered and filed counter-claims to Dr. Kottayil’s amended complaint. The counter-claims include actions for breach of fiduciary duty, fraud and negligent misrepresentations and omissions with respect to the time during which Dr. Kottayil was employed at Insys Pharma. The counter-claims, among other relief, sought compensatory and punitive damages. On January 29, 2014, the plaintiffs filed a second amended complaint in the Arizona Superior Court in which Insys Therapeutics, Inc. was also named as defendant in this lawsuit. This amended complaint filed by plaintiffs re-alleged substantially the same claims set forth in the prior complaint, except that plaintiffs also alleged that they were entitled to rescissory damages, added our majority stockholder, a private trust, as a defendant to the breach of fiduciary duty claim and revised their fraud claim against the Insys Pharma director defendants. The trial commenced on December 1, 2014, with the evidence phase of the trial completed on January 29, 2015. On June 8, 2015, the court issued findings of fact and conclusions of law in its final trial ruling. Specifically, the court found (i) in favor of Insys Pharma, our majority stockholder, a private trust and four of the Insys Pharma directors who were on the board in July 2008 on plaintiffs’ claim for breach of fiduciary duty arising out of transactions the board approved in July 2008, (ii) found in favor of plaintiffs and against Insys Pharma, Inc., our majority stockholder, a private trust and three of the Insys Pharma directors who were on the board in June 2009 on plaintiffs’ claims under Delaware law and for breach of fiduciary duties arising out of the reverse stock split the board approved in June 2009 in the amount of $7,317,450, along with pre-judgment and post-judgment interest and court costs, (iii) found in favor of two of the Insys Pharma directors who were on the Insys Pharma board as of June 2009 and against plaintiffs on plaintiffs’ breach of fiduciary duty claims, (iv) found in favor of Insys Pharma and against plaintiff (Kottayil) on his claim for rescission of the patent application assignments that he entered in favor of Insys Pharma before and after his employment terminated, (v) found in favor of Insys Therapeutics, Inc. and against plaintiff on plaintiffs' claims of successor liability and fraudulent transfer, and (vi) found in favor of Kottayil and against Insys Pharma on Insys Pharma’s counterclaims of breach of fiduciary duty, fraud, and negligent misrepresentation. On October 2, 2015, the court entered a final judgment, awarding plaintiffs the amount of $7,317,450, along with pre-judgment interest from June 2, 2009, and post-judgment interest, from October 2, 2015, at the rate of 4.25% per annum, compounded quarterly and taxable costs in the amount of $93,163. On the same date, the court denied Kottayil’s request to submit an application for attorneys’ fees for his defense of the Insys Pharma counterclaims, finding that the request was premature. As a result of the final ruling, we have accrued $9,567,000 at March 31, 2017, including $2,249,000 of estimated pre-judgement interest, which represents our current best estimate of this contingent liability. The final outcome of the appeal could cause this estimate to vary materially from the final award. On October 20, 2015, plaintiffs appealed the foregoing judgment and on November 4, 2015, Insys Pharma and the other defendants against whom judgment was entered filed a notice of cross-appeal. The appeal and cross-appeal remain pending before the Court of Appeals for the State of Arizona. On or around November 1, 2015, we received a notice from the plaintiff’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 yet. Accordingly, we are still in the process of assessing the merit of such claims as well as evaluating the basis for the costs claimed. Because of the uncertainty surrounding the ultimate outcome, we have not accrued for this claim at this time; however, we believe that that it is reasonably possible that there may be a material loss associated with this claim and we currently estimate the range of the reasonably possible loss to be between $0 and the $3,630,000 claimed. On or about August 1, 2016, plaintiffs filed opening and reply and cross response briefs and we filed our answering and cross-appeal brief and our reply in support of our cross-appeal. On Wednesday, April 5, 2017, the Arizona Court of Appeals conducted oral argument on the plaintiffs’ appeal and on our cross-appeal. The parties now await a decision from the Arizona Court of Appeals. Markland . On July 1, 2016, Robert N. Markland, as the Personal Representative of the Estate of Carolyn S. Markland filed a complaint in the Circuit Court, Fourth Judicial Circuit, in and for Duval County, Florida, against Insys Therapeutics, Inc. The complaint states that it is a wrongful death products liability action brought pursuant to Section 768.16, et seq. under Florida law in connection with a death occurring in July 2014 and includes a claim of negligent marketing. The lawsuit seeks unspecified damages for past expenses and costs, pain and suffering and loss of consortium and earnings. On August 4, 2016, we removed this case to federal district court in the Middle District of Florida. On September 2, 2016, we filed a motion to dismiss and are awaiting the court’s ruling. We intend to vigorously defend this matter and based on currently available information, we do not believe any resolution of this matter will have a material adverse effect on our business, financial position, or future results of operations. Buchalter . On September 9, 2016, Jeffrey Buchalter filed a complaint in the Circuit Court for Anne Arundel County, Maryland, Case No. C-02-cv-16-002718, against Dr. William Tham, Physical Medicine & Pain Management Associates, Maryland Neurological Institute, various physician assistants, and Insys Therapeutics, Inc. Plaintiff’s complaint states it is a personal injury action against Insys related to negligent misrepresentation, failure to warn and fraud under state laws. The lawsuit seeks unspecified compensatory and punitive damages. We have filed a motion to dismiss and on or about May 6, 2017, the court denied the motion to dismiss. We intend to vigorously defend this matter and based on currently available information, we do not believe any resolution of this matter will have a material adverse effect on our business, financial position, or future results of operations. Colby . On or about January 25, 2017, Mackenzie Colby filed a complaint in the State of New Hampshire Strafford County Superior Court, Case No. 219-2017-CV-00040, against Christopher Clough, PA, Dr. O’Connell’s Pain Care Centers, Inc., and Insys Therapeutics, Inc. Plaintiff’s complaint states it is a personal injury action against Mr. Clough related to medical negligence, against O’Connell’s Pain Care Centers, Inc. for respondeat superior claims, and against Insys Therapeutics, Inc. for negligence, all under state laws. The lawsuit seeks unspecified compensatory and punitive damages. We intend to vigorously defend this matter and based on currently available information, we do not believe any resolution of this matter will have a material adverse effect on our business, financial position, or future results of operations. Perusse . On or about February 21, 2017, John Perusse filed a complaint in the State of New Hampshire Strafford County Superior Court, Case No. 219-2017-CV-00067, against Christopher Clough, PA, Dr. John J Schermerhorn, Dr. O’Connell’s Pain Care Centers, Inc., and Insys Therapeutics, Inc. Plaintiff’s complaint states it is a personal injury action against Mr. Clough related to medical negligence, against O’Connell’s Pain Care Centers, Inc. for respondeat superior claims, and against Insys Therapeutics, Inc. and Dr. Schermerhorn for negligence, all under state laws. The lawsuit seeks unspecified compensatory and punitive damages. We filed a motion to dismiss/strike on April 20, 2017 and plaintiff filed a motion to amend the complaint on April 25, 2017. Both of these motions are pending. We intend to vigorously defend this matter and based on currently available information, we do not believe any resolution of this matter will have a material adverse effect on our business, financial position, or future results of operations. Cassell . On or about March 8, 2017, Jerome Cassell filed a complaint in the State of New Hampshire Strafford County Superior Court, Case No. 219-2017-CV-00085, against Christopher Clough, PA, Dr. John J Schermerhorn, Dr. O’Connell’s Pain Care Centers, Inc., and Insys Therapeutics, Inc. Plaintiff’s complaint states it is a personal injury action against Mr. Clough related to medical negligence, against O’Connell’s Pain Care Centers, Inc. for respondeat superior claims, and against Insys Therapeutics, Inc. and Dr. Schermerhorn for negligence, all under state laws. The lawsuit seeks unspecified compensatory and punitive damages. We filed a motion to dismiss/strike on April 18, 2017 and plaintiff filed a motion to amend the complaint on April 25, 2017. Both of these motions are pending. We intend to vigorously defend this matter and based on currently available information, we do not believe any resolution of this matter will have a material adverse effect on our business, financial position, or future results of operations. Carver . On or about March 20, 2017, a qui tam complaint entitled United States ex rel. Lori L. Carver v. Physicians Pain Specialists of Alabama, P.C., Xiulu Ruan, M.D., John Patrick Couch, M.D., C&R Pharmacy, LLC, Castle Medical, LLC, Insys Therapeutics, Inc., Industrial Pharmacy Management, LLC and Christopher Manfuso; Case No. 13-392, that had been filed under seal with the U.S. District Court for the Southern Distr |
Note 7 - Stock-based Compensati
Note 7 - Stock-based Compensation | 3 Months Ended |
Mar. 31, 2017 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-based Compensation | 7. Stock-based Compensation Amounts recognized in the condensed consolidated statements of operations and comprehensive income (loss) with respect to our stock-based compensation plans were as follows (in thousands): Three Months Ended March 31, 2017 2016 Research and development $ 1,033 $ 861 General and administrative 2,959 3,265 Total cost of stock-based compensation $ 3,992 $ 4,126 The following table summarizes stock option activity during the three months ended March 31, 2017: 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, 2016 4,474,906 $ 9.05 Outstanding as of December 31, 2016 7,300,873 $ 12.36 Granted 1,216,000 $ 12.53 Cancelled (301,133 ) $ 17.30 Exercised (191,249 ) $ 3.42 Outstanding as of March 31, 2017 8,024,491 $ 12.42 7.5 $ 21.1 Vested and exercisable as of March 31, 2017 4,570,276 $ 9.61 6.3 $ 20.7 As of March 31, 2017, we expected to recognize $33,459,000 of stock-based compensation for outstanding options over a weighted-average period of 2.8 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 three months ended March 31, 2017: Weighted Average Number of Grant-Date Fair Units Value Per Unit Outstanding as of December 31, 2016 — $ — Granted 282,000 $ 12.65 Vested — $ — Cancelled (2,000 ) $ 12.65 Outstanding as of March 31, 2017 280,000 $ 12.65 As of March 31, 2017, we expected to recognize $3,394,000 of stock-based compensation for outstanding restricted stock units over a weighted-average period of 2.7 years. Cash received from option exercises under all stock-based payment arrangements for the three months ended March 31, 2017 and 2016 was $654,000 and $1,310,000, respectively. For the three months ended March 31, 2016, we recorded net reductions of $653,000 of our federal and state income tax liability, with an offsetting credit to additional paid-in capital, resulting from the excess tax benefits of stock options. Effective January 1, 2017, the adoption of ASU 2016-09 eliminated the recognition of excess tax benefits of stock options in additional paid-in capital. All excess tax benefits and tax deficiencies on stock-based payment awards are recognized as income tax expense or benefit in the consolidated statement of operations and comprehensive income (loss). The tax effects of exercised or vested awards are treated as discrete items in the reporting period in which they occur. For the three months ended March 31, 2017, we recorded net reductions of $192,000 of our federal and state income tax liability, with an offsetting credit recorded within income tax expense, resulting from the excess tax benefits of stock options. |
Note- 8 - Net Income (Loss) per
Note- 8 - Net Income (Loss) per Share | 3 Months Ended |
Mar. 31, 2017 | |
Earnings Per Share [Abstract] | |
Net Income (Loss) per Share | 8. Net Income (Loss) per Share Basic net income (loss) per common share is computed by dividing the net income 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 income (loss) per common share (dollars in thousands, except per share amounts): Three Months Ended March 31, 2017 2016 Historical net income (loss) per share - Basic Numerator: Net income (loss) $ (6,524 ) $ 2,290 Denominator: Weighted average number of common shares outstanding 71,945,743 71,592,089 Basic net income (loss) per common share $ (0.09 ) $ 0.03 Historical net income (loss) per share - Diluted Numerator: Net income (loss) $ (6,524 ) $ 2,290 Denominator: Weighted average number of common shares outstanding 71,945,743 71,592,089 Effect of dilutive stock options — 2,870,789 Weighted average number of common shares outstanding 71,945,743 74,462,878 Diluted net income (loss) per common share $ (0.09 ) $ 0.03 As we have incurred a net loss for the three months ended March 31, 2017, basic and diluted per share amounts are the same, since the effect of potential common share equivalents is anti-dilutive. |
Note 9 - Product Lines, Concent
Note 9 - Product Lines, Concentration of Credit Risk and Significant Customers | 3 Months Ended |
Mar. 31, 2017 | |
Segment Reporting [Abstract] | |
Product Lines, Concentration of Credit Risk and Significant Customers | 9. Product Lines, Concentration of Credit Risk and Significant Customers We are engaged in the business of developing and selling pharmaceutical products. In 2017 and 2016, we had one product line, SUBSYS®. Our chief operating decision-maker evaluates revenues based on product lines. The following table summarizes our percentage of revenue by route to market (in thousands): Percent of Revenue by Route to Market Three Months Ended March 31, 2017 2016 Pharmaceutical wholesalers 66 % 73 % Specialty pharmaceutical retailers 34 % 27 % 100 % 100 % All our products are sold in the United States of America. Product shipments to our four largest pharmaceutical wholesalers accounted for 21%, 20%, 11%, and 10% of total shipments and product shipments to one specialty pharmaceutical retailer accounted for 31% of total shipments for the three months ended March 31, 2017. Product shipments to our three largest pharmaceutical wholesalers accounted for 21%, 19% and 16% of total shipments and product shipments to one specialty pharmaceutical retailer accounted for 27% of total shipments for the three months ended March 31, 2016. Our four largest pharmaceutical wholesalers’ accounts receivable balances accounted for 28%, 21%, 20%, and 16% of gross accounts receivable as of March 31, 2017. Our two largest pharmaceutical wholesalers’ accounts receivable balances accounted for 25% and 25% of gross accounts receivable as of March 31, 2016. |
Nature of Business and Basis of
Nature of Business and Basis of Presentation (Policies) | 3 Months Ended |
Mar. 31, 2017 | |
Accounting Policies [Abstract] | |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements Effective January 1, 2017, we adopted ASU No. 2016-09, Compensation-Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting. Among other requirements, the new guidance requires all tax effects related to share-based payments at settlement (or expiration) to be recorded through the income statement. Previously, tax benefits in excess of compensation cost ("windfalls") were recorded in equity, and tax deficiencies ("shortfalls") were recorded in equity to the extent of previous windfalls, and then to the income statement. As required, this change was applied prospectively to all excess tax benefits and tax deficiencies resulting from settlements. Under the new guidance, the windfall tax benefit is to be recorded when it arises, subject to normal valuation allowance considerations. Excess tax benefits that were not previously recognized because the related tax deduction had not reduced current taxes payable were recorded through a cumulative effect adjustment as of the date of the adoption. As required, this change was applied on a modified retrospective basis, with a cumulative effect adjustment of change in accounting principle of approximately $368,000 as a deferred tax asset with a corresponding valuation allowance of $368,000, which were offset in retained earnings. Additionally, our condensed consolidated statement of cash flows now presents excess tax benefits as an operating activity, adjusted prospectively with no adjustments made to prior periods. Additionally, ASU No. 2016-09 addressed the presentation of employee taxes paid on the statement of cash flows. We are now required to present the cost of shares withheld from the employee to satisfy the employees’ income tax liability as a financing activity on the statement of cash flows rather than as an operating cash flow. This change was applied on a retrospective basis, as required, but did not impact the condensed consolidated statement of cash flows for the three months ended March 31, 2016. ASU 2016-09 also permits entities to make an accounting policy election related to how forfeitures will impact the recognition of compensation cost for stock-based compensation to either estimate the total number of awards for which the requisite service period will not be rendered, as currently required, or to account for forfeitures as they occur. Upon adoption of ASU 2016-09, we elected to change our accounting policy to account for forfeitures as they occur. As required, this change was applied on a modified retrospective basis; however, as of December 31, 2016, we had estimated no forfeitures relating to the outstanding equity awards. As a result, no adjustment was required. Going forward, the adoption of ASU 2016-09 could cause volatility in the effective tax rate, as the excess tax benefits associated with the exercise of stock options could generate a significant discrete income tax benefit in a particular interim period, potentially creating volatility in net income and net income per share period-to-period and period-over-period. Effective January 1, 2017, we adopted ASU No. 2015-11, Inventory (Topic 330): Simplifying the Measurement of Inventory. Prior to January 1, 2017, we measured inventory at the lower of cost or market. This guidance requires us to measure inventory at the lower of cost and NRV, which eliminates the need to determine replacement cost and evaluate whether it is above the ceiling (NRV) or below the floor (NRV less a normal profit margin). The guidance defines NRV as the “estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation.” The adoption of this guidance did not have a material impact on our condensed consolidated financial statements. |
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 consolidated financial statements. In October 2016, the FASB issued ASU No. 2016-16, Income Taxes (Topic 740): Intra-Entity Transfers of Assets Other Than Inventory, to improve the accounting for the income tax consequences of intra-entity transfers of assets other than inventory. Current U. S. GAAP prohibits the recognition of current and deferred income taxes for an intra-entity asset transfer until the asset has been sold to an outside party, which is an exception to the principle of comprehensive recognition of current and deferred income taxes in U. S. GAAP. The amendments in this update eliminate the exception for an intra-entity transfer of an asset other than inventory. The amendments should be applied on a modified retrospective transition basis, and are effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years, and early adoption is permitted. We are currently evaluating the impact of these amendments on our consolidated financial statements. In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments. The amendments effected by this ASU affect entities required to present a statement of cash flows and provide specific guidance on a variety of cash flow issues to reduce current and potential future diversity in practice. The amendments are effective for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years, and early adoption is permitted. An entity that elects early adoption must adopt all of the amendments in the same period. The amendments should be applied using a retrospective transition method to each period presented. We are currently evaluating the impact of these amendments on our 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 are currently evaluating the impact of these amendments on our 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 are currently evaluating the impact of these amendments on our consolidated financial statements and related disclosures; however, based on our current operating leases, we do not expect that the adoption of this guidance will have a material impact on the consolidated financial statements. See Note 6, Commitments and Contingencies, In January 2016, the FASB issued ASU No. 2016-01, Financial Instruments—Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities, which amended the Financial Instruments topic of the ASC to address certain aspects of recognition, measurement, presentation, and disclosure of financial instruments. The amendments will be effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years, and early adoption is not permitted. These amendments should be applied by means of a cumulative-effect adjustment to the balance sheet as of the beginning of the fiscal year of adoption. The amendments related to equity securities without readily determinable fair values (including disclosure requirements) should be applied prospectively to equity investments that exist as of the date of adoption. We are currently evaluating the impact of these amendments on our consolidated financial statements In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606). The new 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 standard requires that reporting companies disclose the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers. The new standard is required to be applied either retrospectively to each prior reporting period presented or retrospectively with the cumulative effect of initially applying it recognized at the date of initial application. In March 2016 and April 2016, the FASB issued ASU No. 2016-08 and ASU No. 2016-10, respectively, which further clarified the implementation guidance on principal versus agent considerations contained in ASU No. 2014-09 and the identification of performance obligations and licensing, respectively. In May 2016, the FASB issued ASU 2016-12, Narrow-Scope Improvements and Practical Expedients, which provides clarification on assessing the collectability criterion, presentation of sales taxes, measurement date for non-cash consideration and completed contracts at transition. These standards will be effective for annual periods beginning after December 15, 2017, and interim periods therein, using either of the following transition methods: (i) a full retrospective approach reflecting the application of the standard in each prior reporting period with the option to elect certain practical expedients, or (ii) a retrospective approach with the cumulative effect of initially adopting ASU 2014-09 recognized at the date of adoption (which includes additional footnote disclosures). Early adoption is permitted, but not before December 15, 2016, the original effective date of the standard. We are currently analyzing ASU 2014-09, and the related ASUs, to evaluate the impact of the new standard on existing contracts with our customers. This includes reviewing current accounting policies and practices to identify potential differences that would result from applying the requirements under the new standard. We initiated a contract review process during 2016 and expect to complete the contract evaluations and validate results by the end of the second quarter of 2017. We have also started evaluating our existing accounting policies and the new disclosure requirements and expect to complete our evaluation of the impacts of the accounting and disclosure requirements on our business processes, controls and systems by the end of the second quarter of 2017. Additionally, we will continue to monitor industry activities and any additional guidance provided by regulators, standards setters, or the accounting profession and adjust our assessment and implementation plans accordingly. Full implementation will be completed by the end of 2017. We have not yet determined our selected method of transition. |
Note 3 - Short-term and Long-17
Note 3 - Short-term and Long-term Investments (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Schedule Of Investments [Abstract] | |
Summary of Investments | Investments consisted of the following at March 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 $ 28,562 $ — $ — $ — $ 28,562 $ 28,562 $ — $ — Money market securities 34,802 — — — 34,802 34,802 — — Marketable securities: Certificates of deposit 25,919 — — — 25,919 — 14,055 11,864 Commercial paper 11,963 — — — 11,963 4,497 7,466 — Corporate securities 53,815 6 (120 ) — 53,701 — 34,371 19,330 Federal agency securities 33,320 3 (94 ) — 33,229 — 10,502 22,727 Municipal securities 30,326 6 (28 ) — 30,304 512 20,520 9,272 Total marketable securities 155,343 15 (242 ) — 155,116 5,009 86,914 63,193 $ 218,707 $ 15 $ (242 ) $ — $ 218,480 $ 68,373 $ 86,914 $ 63,193 Investments consisted of the following at December 31, 2016 (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 $ 49,331 $ — $ — $ — $ 49,331 $ 49,331 $ — $ — Money market securities 54,015 — — — 54,015 54,015 — — Marketable securities: Certificates of deposit 26,114 — — — 26,114 — 13,855 12,259 Commercial paper 1,485 — — — 1,485 — 1,485 — Corporate securities 39,562 — (135 ) — 39,427 500 25,681 13,246 Federal agency securities 30,660 4 (92 ) — 30,572 — 10,854 19,718 Municipal securities 35,811 2 (81 ) — 35,732 796 26,363 8,573 Total marketable securities 133,632 6 (308 ) — 133,330 1,296 78,238 53,796 $ 236,978 $ 6 $ (308 ) $ — $ 236,676 $ 104,642 $ 78,238 $ 53,796 |
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): March 31, 2017 December 31, 2016 Amortized Cost Fair Value Amortized Cost Fair Value Marketable securities: Due in one year or less $ 93,976 $ 93,924 $ 80,092 $ 80,027 Due after one year through 5 years 61,367 61,192 53,540 53,303 Due after 5 years through 10 years — — — — Due after 10 years — — — — $ 155,343 $ 155,116 $ 133,632 $ 133,330 |
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): March 31, 2017 December 31, 2016 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 $ 48,277 $ (120 ) $ — $ — $ 38,027 $ (134 ) $ 401 $ (1 ) Federal agency securities 26,878 (93 ) 1,205 (1 ) 26,449 (91 ) 1,217 (1 ) Municipal securities 16,870 (28 ) — — 30,373 (81 ) 100 — $ 92,025 $ (241 ) $ 1,205 $ (1 ) $ 94,849 $ (306 ) $ 1,718 $ (2 ) |
Note 4 - Fair Value Measureme18
Note 4 - Fair Value Measurement (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Fair Value Disclosures [Abstract] | |
Summary of Investments Measured at Fair Value on Recurring Basis | Our investments measured at fair value on a recurring basis subject to the disclosure requirements of ASC 820 at March 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) Marketable securities: Certificates of deposit $ 25,919 $ — $ 25,919 $ — Commercial paper 11,963 — 11,963 — Corporate securities 53,701 — 53,183 518 Federal agency securities 33,229 — 33,229 — Municipal securities 30,304 — 30,304 — Total assets measured at fair value $ 155,116 $ — $ 154,598 $ 518 Our investments measured at fair value on a recurring basis subject to the disclosure requirements of ASC 820 at December 31, 2016 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) Marketable securities: Certificates of deposit $ 26,114 $ — $ 26,114 $ — Commercial paper 1,485 — 1,485 — Corporate securities 39,427 — 38,927 500 Federal agency securities 30,572 — 30,572 — Municipal securities 35,732 — 35,732 — Total assets measured at fair value $ 133,330 $ — $ 132,830 $ 500 |
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 months ended March 31, 2017 and 2016 (in thousands): Three Months Ended March 31, 2017 2016 Convertible stock Balance, beginning of period $ 500 $ — Change in fair value 18 — Purchases — — Balance, end of period $ 518 $ — |
Note 5 - Inventories, Net (Tabl
Note 5 - Inventories, Net (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Inventory Disclosure [Abstract] | |
Schedule of Components of Inventories Net of Allowances | March 31, December 31, 2017 2016 Finished goods $ 7,105 $ 8,408 Work-in-process 6,760 6,183 Raw materials and supplies 7,423 5,823 Total inventories 21,288 20,414 Plus: non-current raw materials and supplies and finished goods 3,725 6,257 $ 25,013 $ 26,671 |
Note 6 - Commitments and Cont20
Note 6 - Commitments and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Commitments And Contingencies Disclosure [Abstract] | |
Summary of Aggregate Minimum Purchase Commitments | The following table sets forth our aggregate minimum purchase commitments with DPT and Aptar under these agreements (in thousands): Years ending December 31, Remainder of 2017 $ 6,000 2018 7,500 2019 8,410 2020 8,550 2021 4,330 Thereafter — Total $ 34,790 |
Note 7 - Stock-based Compensa21
Note 7 - Stock-based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
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 income (loss) with respect to our stock-based compensation plans were as follows (in thousands): Three Months Ended March 31, 2017 2016 Research and development $ 1,033 $ 861 General and administrative 2,959 3,265 Total cost of stock-based compensation $ 3,992 $ 4,126 |
Summary of Stock Option Activity | The following table summarizes stock option activity during the three months ended March 31, 2017: 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, 2016 4,474,906 $ 9.05 Outstanding as of December 31, 2016 7,300,873 $ 12.36 Granted 1,216,000 $ 12.53 Cancelled (301,133 ) $ 17.30 Exercised (191,249 ) $ 3.42 Outstanding as of March 31, 2017 8,024,491 $ 12.42 7.5 $ 21.1 Vested and exercisable as of March 31, 2017 4,570,276 $ 9.61 6.3 $ 20.7 |
Summary of Restricted Stock Unit Activity | The following table summarizes restricted stock unit activity during the three months ended March 31, 2017: Weighted Average Number of Grant-Date Fair Units Value Per Unit Outstanding as of December 31, 2016 — $ — Granted 282,000 $ 12.65 Vested — $ — Cancelled (2,000 ) $ 12.65 Outstanding as of March 31, 2017 280,000 $ 12.65 |
Note- 8 - Net Income (Loss) P22
Note- 8 - Net Income (Loss) Per Share (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Earnings Per Share [Abstract] | |
Schedule of Computation of Basic and Diluted Net Income (Loss) Per Common Share | The following table sets forth the computation of basic and diluted net income (loss) per common share (dollars in thousands, except per share amounts): Three Months Ended March 31, 2017 2016 Historical net income (loss) per share - Basic Numerator: Net income (loss) $ (6,524 ) $ 2,290 Denominator: Weighted average number of common shares outstanding 71,945,743 71,592,089 Basic net income (loss) per common share $ (0.09 ) $ 0.03 Historical net income (loss) per share - Diluted Numerator: Net income (loss) $ (6,524 ) $ 2,290 Denominator: Weighted average number of common shares outstanding 71,945,743 71,592,089 Effect of dilutive stock options — 2,870,789 Weighted average number of common shares outstanding 71,945,743 74,462,878 Diluted net income (loss) per common share $ (0.09 ) $ 0.03 |
Note 9 - Product Lines, Conce23
Note 9 - Product Lines, Concentration of Credit Risk and Significant Customers (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Segment Reporting [Abstract] | |
Percentage of Revenue by Route to Market | The following table summarizes our percentage of revenue by route to market (in thousands): Percent of Revenue by Route to Market Three Months Ended March 31, 2017 2016 Pharmaceutical wholesalers 66 % 73 % Specialty pharmaceutical retailers 34 % 27 % 100 % 100 % |
Note 1 - Nature of Business a24
Note 1 - Nature of Business and Basis of Presentation (Details Textual) | 3 Months Ended | |
Mar. 31, 2017USD ($)ProductLine | Dec. 31, 2016USD ($)shares | |
ASU No. 2016-09 [Member] | ||
Nature Of Business [Line Items] | ||
Estimated forfeitures relating to outstanding equity awards | shares | 0 | |
Adjustment to forfeitures relating to outstanding equity awards | $ 0 | |
ASU No. 2016-09 [Member] | Deferred Tax Asset [Member] | ||
Nature Of Business [Line Items] | ||
Cumulative effect adjustment of change in accounting principle | $ 368,000 | |
ASU No. 2016-09 [Member] | Deferred Tax Asset Valuation Allowance [Member] | ||
Nature Of Business [Line Items] | ||
Cumulative effect adjustment of change in accounting principle | $ 368,000 | |
SUBSYS [Member] | ||
Nature Of Business [Line Items] | ||
Number of Product Lines | ProductLine | 1 | |
SYNDROS [Member] | ||
Nature Of Business [Line Items] | ||
Number of Product Awaiting Approval | ProductLine | 1 |
Note 2 - Revenue Recognition (D
Note 2 - Revenue Recognition (Details Textual) - SUBSYS [Member] | 3 Months Ended |
Mar. 31, 2017 | |
Revenue Recognition [Line Items] | |
Shelf Life of Product from Date of Manufacture | 36 months |
Product Return, Period Prior to Expiration | 6 months |
Product Return, Period After Expiration | 12 months |
Cash Discount, Percent | 2.00% |
Note 3 - Short-term and Long-26
Note 3 - Short-term and Long-term Investments (Details Textual) - USD ($) | 3 Months Ended | ||
Mar. 31, 2017 | Mar. 31, 2016 | Dec. 31, 2016 | |
Schedule Of Investments [Line Items] | |||
Reclassifications on available-for-sale securities | $ 0 | $ 0 | |
Investment Owned, at Fair Value | 218,480,000 | $ 236,676,000 | |
Cash and Cash Equivalents [Member] | |||
Schedule Of Investments [Line Items] | |||
Investment Owned, at Fair Value | 5,009,000 | ||
Short-term Investments [Member] | |||
Schedule Of Investments [Line Items] | |||
Investment Owned, at Fair Value | 86,914,000 | ||
Long-term Investments [Member] | |||
Schedule Of Investments [Line Items] | |||
Investment Owned, at Fair Value | $ 63,193,000 |
Note 3 - Short-term and Long-27
Note 3 - Short-term and Long-term Investments - Summary of Investments (Details) - USD ($) $ in Thousands | Mar. 31, 2017 | Dec. 31, 2016 | Mar. 31, 2016 | Dec. 31, 2015 |
Schedule Of Investments [Line Items] | ||||
Cost | $ 218,707 | $ 236,978 | ||
Unrealized Gains | 15 | 6 | ||
Unrealized Losses | (242) | (308) | ||
Fair Value | 218,480 | 236,676 | ||
Cash and Cash Equivalents | 68,373 | 104,642 | $ 73,820 | $ 79,515 |
Short-term Investments | 86,914 | 78,238 | ||
Long-term Investments | 63,193 | 53,796 | ||
Commercial Paper [Member] | ||||
Schedule Of Investments [Line Items] | ||||
Cost | 11,963 | 1,485 | ||
Fair Value | 11,963 | 1,485 | ||
Cash and Cash Equivalents | 4,497 | |||
Short-term Investments | 7,466 | 1,485 | ||
Corporate Securities [Member] | ||||
Schedule Of Investments [Line Items] | ||||
Cost | 53,815 | 39,562 | ||
Unrealized Gains | 6 | |||
Unrealized Losses | (120) | (135) | ||
Fair Value | 53,701 | 39,427 | ||
Cash and Cash Equivalents | 500 | |||
Short-term Investments | 34,371 | 25,681 | ||
Long-term Investments | 19,330 | 13,246 | ||
Federal Agency Securities [Member] | ||||
Schedule Of Investments [Line Items] | ||||
Cost | 33,320 | 30,660 | ||
Unrealized Gains | 3 | 4 | ||
Unrealized Losses | (94) | (92) | ||
Fair Value | 33,229 | 30,572 | ||
Short-term Investments | 10,502 | 10,854 | ||
Long-term Investments | 22,727 | 19,718 | ||
Municipal Securities [Member] | ||||
Schedule Of Investments [Line Items] | ||||
Cost | 30,326 | 35,811 | ||
Unrealized Gains | 6 | 2 | ||
Unrealized Losses | (28) | (81) | ||
Fair Value | 30,304 | 35,732 | ||
Cash and Cash Equivalents | 512 | 796 | ||
Short-term Investments | 20,520 | 26,363 | ||
Long-term Investments | 9,272 | 8,573 | ||
Marketable Securities [Member] | ||||
Schedule Of Investments [Line Items] | ||||
Cost | 155,343 | 133,632 | ||
Unrealized Gains | 15 | 6 | ||
Unrealized Losses | (242) | (308) | ||
Fair Value | 155,116 | 133,330 | ||
Cash and Cash Equivalents | 5,009 | 1,296 | ||
Short-term Investments | 86,914 | 78,238 | ||
Long-term Investments | 63,193 | 53,796 | ||
Cash [Member] | ||||
Schedule Of Investments [Line Items] | ||||
Cost | 28,562 | 49,331 | ||
Fair Value | 28,562 | 49,331 | ||
Cash and Cash Equivalents | 28,562 | 49,331 | ||
Money Market Securities [Member] | ||||
Schedule Of Investments [Line Items] | ||||
Cost | 34,802 | 54,015 | ||
Fair Value | 34,802 | 54,015 | ||
Cash and Cash Equivalents | 34,802 | 54,015 | ||
Certificates of Deposit [Member] | ||||
Schedule Of Investments [Line Items] | ||||
Cost | 25,919 | 26,114 | ||
Fair Value | 25,919 | 26,114 | ||
Short-term Investments | 14,055 | 13,855 | ||
Long-term Investments | $ 11,864 | $ 12,259 |
Note 3 - Short-term and Long-28
Note 3 - Short-term and Long-term Investments - Summary of Amortized Cost and Estimated Fair Value of Securities By Maturity (Details) - USD ($) $ in Thousands | Mar. 31, 2017 | Dec. 31, 2016 |
Marketable securities: | ||
Due in one year or less, Amortized Cost | $ 93,976 | $ 80,092 |
Due after one year through 5 years, Amortized Cost | 61,367 | 53,540 |
Total, Amortized Cost | 155,343 | 133,632 |
Due in one year or less, Fair Value | 93,924 | 80,027 |
Due after one year through 5 years, Fair Value | 61,192 | 53,303 |
Total, Fair value | $ 155,116 | $ 133,330 |
Note 3 - Short-term and Long-29
Note 3 - Short-term and Long-term Investments - Summary of Gross Unrealized Losses and Fair Value of Investments (Details) - USD ($) $ in Thousands | Mar. 31, 2017 | Dec. 31, 2016 |
Marketable securities: | ||
Less Than 12 Months Fair Value | $ 92,025 | $ 94,849 |
Less Than 12 Months Unrealized Loss | (241) | (306) |
Greater Than 12 Months Fair Value | 1,205 | 1,718 |
Greater Than 12 Months Unrealized Loss | (1) | (2) |
Corporate Bond Securities [Member] | ||
Marketable securities: | ||
Less Than 12 Months Fair Value | 48,277 | 38,027 |
Less Than 12 Months Unrealized Loss | (120) | (134) |
Greater Than 12 Months Fair Value | 401 | |
Greater Than 12 Months Unrealized Loss | (1) | |
Federal Agency Securities [Member] | ||
Marketable securities: | ||
Less Than 12 Months Fair Value | 26,878 | 26,449 |
Less Than 12 Months Unrealized Loss | (93) | (91) |
Greater Than 12 Months Fair Value | 1,205 | 1,217 |
Greater Than 12 Months Unrealized Loss | (1) | (1) |
Municipal Securities [Member] | ||
Marketable securities: | ||
Less Than 12 Months Fair Value | 16,870 | 30,373 |
Less Than 12 Months Unrealized Loss | $ (28) | (81) |
Greater Than 12 Months Fair Value | $ 100 |
Note 4 - Fair Value Measureme30
Note 4 - Fair Value Measurement - Summary of Investments Measured at Fair Value on Recurring Basis (Detail) - USD ($) $ in Thousands | Mar. 31, 2017 | Dec. 31, 2016 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | $ 155,116 | $ 133,330 |
Significant Other Observable Inputs (Level 2) [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 154,598 | 132,830 |
Significant Unobservable Inputs (Level 3) [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 518 | 500 |
Certificates of Deposit [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 25,919 | 26,114 |
Certificates of Deposit [Member] | Significant Other Observable Inputs (Level 2) [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 25,919 | 26,114 |
Commercial Paper [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 11,963 | 1,485 |
Commercial Paper [Member] | Significant Other Observable Inputs (Level 2) [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 11,963 | 1,485 |
Corporate Securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 53,701 | 39,427 |
Corporate Securities [Member] | Significant Other Observable Inputs (Level 2) [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 53,183 | 38,927 |
Corporate Securities [Member] | Significant Unobservable Inputs (Level 3) [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 518 | 500 |
Federal Agency Securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 33,229 | 30,572 |
Federal Agency Securities [Member] | Significant Other Observable Inputs (Level 2) [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 33,229 | 30,572 |
Municipal Securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 30,304 | 35,732 |
Municipal Securities [Member] | Significant Other Observable Inputs (Level 2) [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | $ 30,304 | $ 35,732 |
Note 4 - Fair Value Measureme31
Note 4 - Fair Value Measurement - Summary of Additional Information about Assets Measured at Fair Value (Detail) $ in Thousands | 3 Months Ended |
Mar. 31, 2017USD ($) | |
Fair Value Disclosures [Abstract] | |
Balance, beginning of period | $ 500 |
Change in fair value | 18 |
Balance, end of period | $ 518 |
Note 5 - Inventories, Net - Sch
Note 5 - Inventories, Net - Schedule of Components of Inventories Net of Allowances (Details) - USD ($) $ in Thousands | Mar. 31, 2017 | Dec. 31, 2016 |
Inventory Disclosure [Abstract] | ||
Finished goods | $ 7,105 | $ 8,408 |
Work-in-process | 6,760 | 6,183 |
Raw materials and supplies | 7,423 | 5,823 |
Total inventories | 21,288 | 20,414 |
Plus: non-current raw materials and supplies and finished goods | 3,725 | 6,257 |
Inventories, net | $ 25,013 | $ 26,671 |
Note 5 - Inventories, Net (Deta
Note 5 - Inventories, Net (Details Textual) - USD ($) | 3 Months Ended | ||
Mar. 31, 2017 | Mar. 31, 2016 | Dec. 31, 2016 | |
Inventory Disclosure [Abstract] | |||
Inventory Valuation Reserves | $ 8,900,000 | $ 6,800,000 | |
Increase in inventory valuation reserves | $ 2,100,000 | $ 0 |
Note 6 - Commitments and Cont34
Note 6 - Commitments and Contingencies (Details Textual) - USD ($) | Jul. 14, 2016 | Mar. 01, 2016 | Nov. 01, 2015 | Oct. 02, 2015 | Jun. 23, 2015 | Jun. 08, 2015 | Oct. 30, 2015 | Apr. 30, 2015 | Mar. 31, 2017 | Dec. 31, 2015 | Jun. 30, 2016 |
Commitments And Contingencies [Line Items] | |||||||||||
Purchase Obligation | $ 34,790,000 | ||||||||||
Anti-Kickback Statute Litigation [Member] | Settled Litigation [Member] | |||||||||||
Commitments And Contingencies [Line Items] | |||||||||||
Payments In Question | $ 83,000 | ||||||||||
Oregon Department of Justice [Member] | Settled Litigation [Member] | |||||||||||
Commitments And Contingencies [Line Items] | |||||||||||
Litigation Settlement, Amount | $ 1,100,000 | ||||||||||
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] | |||||||||||
Loss Contingency, Estimate of Possible Loss | 500,000 | ||||||||||
Kottayil vs. Insys Pharma, Inc. [Member] | Settled Litigation [Member] | |||||||||||
Commitments And Contingencies [Line Items] | |||||||||||
Litigation Settlement, Amount | $ 7,317,450 | ||||||||||
Loss Contingency, Damages Awarded, Value | $ 7,317,450 | ||||||||||
Litigation Settlement, Post-Judgment Interest | 4.25% | ||||||||||
Litigation Settlement, Expense | $ 93,163 | ||||||||||
Estimated Contingent Liability | 9,567,000 | ||||||||||
Kottayil vs. Insys Pharma, Inc. [Member] | Settled Litigation [Member] | Settlement Interest [Member] | |||||||||||
Commitments And Contingencies [Line Items] | |||||||||||
Estimated Contingent Liability | $ 2,249,000 | ||||||||||
Kottayil vs. Insys Pharma, Inc. [Member] | Threatened Litigation [Member] | |||||||||||
Commitments And Contingencies [Line Items] | |||||||||||
Loss Contingency, Damages Sought, Value | $ 3,630,000 | ||||||||||
Kottayil vs. Insys Pharma, Inc. [Member] | Threatened Litigation [Member] | Minimum [Member] | |||||||||||
Commitments And Contingencies [Line Items] | |||||||||||
Loss Contingency, Estimate of Possible Loss | 0 | ||||||||||
Kottayil vs. Insys Pharma, Inc. [Member] | Threatened Litigation [Member] | Maximum [Member] | |||||||||||
Commitments And Contingencies [Line Items] | |||||||||||
Loss Contingency, Estimate of Possible Loss | $ 3,630,000 | ||||||||||
DPT [Member] | |||||||||||
Commitments And Contingencies [Line Items] | |||||||||||
Extended period of agreement | 2,020 | ||||||||||
Purchase Obligation Per Calendar Year | $ 4,000,000 | ||||||||||
Purchase Obligation | $ 16,000,000 | $ 49,740,000 | |||||||||
AptarGroup, Inc [Member] | |||||||||||
Commitments And Contingencies [Line Items] | |||||||||||
Join agreement period | 7 years | ||||||||||
AptarGroup, Inc [Member] | Maximum [Member] | |||||||||||
Commitments And Contingencies [Line Items] | |||||||||||
Tiered royalties as percentage of net revenue | 1.00% |
Note 6 - Commitments and Cont35
Note 6 - Commitments and Contingencies - Summary of Aggregate Minimum Purchase Commitments (Details) $ in Thousands | Mar. 31, 2017USD ($) |
Years ending December 31, | |
Remainder of 2017 | $ 6,000 |
2,018 | 7,500 |
2,019 | 8,410 |
2,020 | 8,550 |
2,021 | 4,330 |
Total | $ 34,790 |
Note 7 - Stock-based Compensa36
Note 7 - Stock-based Compensation - Amounts Recognized in Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) with Respect to Stock-Based Compensation Plans (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total cost of stock-based compensation | $ 3,992 | $ 4,126 |
Research and Development Expense [Member] | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total cost of stock-based compensation | 1,033 | 861 |
General and Administrative Expense [Member] | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total cost of stock-based compensation | $ 2,959 | $ 3,265 |
Note 7 - Stock-based Compensa37
Note 7 - Stock-based Compensation - Summary of Stock Option Activity (Detail) $ / shares in Units, $ in Millions | 3 Months Ended |
Mar. 31, 2017USD ($)$ / sharesshares | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Number of Shares, Vested and exercisable, Beginning balance | shares | 4,474,906 |
Number of Shares, Outstanding, Beginning balance | shares | 7,300,873 |
Number of Shares, Granted | shares | 1,216,000 |
Number of Shares, Cancelled | shares | (301,133) |
Number of Shares, Exercised | shares | (191,249) |
Number of Shares, Outstanding, Ending balance | shares | 8,024,491 |
Number of Shares, Vested and exercisable, Ending balance | shares | 4,570,276 |
Weighted Average Exercise Price, Vested and exercisable, Beginning balance | $ / shares | $ 9.05 |
Weighted Average Exercise Price, Outstanding, Beginning balance | $ / shares | 12.36 |
Weighted Average Exercise Price, Granted | $ / shares | 12.53 |
Weighted Average Exercise Price, Cancelled | $ / shares | 17.30 |
Weighted Average Exercise Price, Exercised | $ / shares | 3.42 |
Weighted Average Exercise Price, Outstanding, Ending balance | $ / shares | 12.42 |
Weighted Average Exercise Price, Vested and exercisable, Ending balance | $ / shares | $ 9.61 |
Weighted Average Remaining Contractual Term, Outstanding as of September 30, 2016 | 7 years 6 months |
Weighted Average Remaining Contractual Term, Vested and exercisable as of March 31, 2017 | 6 years 3 months 18 days |
Aggregate Intrinsic Value, Outstanding as of September 30 2016 | $ | $ 21.1 |
Aggregate Intrinsic Value, Vested and exercisable as of March 31,2017 | $ | $ 20.7 |
Note 7 - Stock-based Compensa38
Note 7 - Stock-based Compensation (Details Textual) - USD ($) | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Stock Options | $ 33,459,000 | |
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 2 years 9 months 18 days | |
Proceeds from Stock Options Exercised | $ 654,000 | $ 1,310,000 |
Employee Service Share-based Compensation, Tax Benefit from Compensation Expense | 653,000 | |
Income tax expense | (5,326,000) | $ 234,000 |
ASU No. 2016-09 [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Income tax expense | $ 192,000 | |
Restricted Stock Unit [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 8 months 12 days | |
Employee service share-based compensation, nonvested awards, compensation not yet recognized | $ 3,394,000 |
Note 7 - Stock-based Compensa39
Note 7 - Stock-based Compensation - Summary of Restricted Stock Unit Activity (Detail) - Restricted Stock Unit [Member] | 3 Months Ended |
Mar. 31, 2017$ / sharesshares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Number of Units, Granted | shares | 282,000 |
Number of Units, Cancelled | shares | (2,000) |
Number of Units, Outstanding, Ending balance | shares | 280,000 |
Weighted Average Grant-Date Fair Value Per Unit, Granted | $ / shares | $ 12.65 |
Weighted Average Grant-Date Fair Value Per Unit, Cancelled | $ / shares | 12.65 |
Weighted Average Grant-Date Fair Value Per Unit, Outstanding, Ending balance | $ / shares | $ 12.65 |
Note 8 - Net Income (Loss) Per
Note 8 - Net Income (Loss) Per Share - Computation of Basic and Diluted Net Income (Loss) Per Common Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Historical net income (loss) per share - Basic | ||
Net income (loss) | $ (6,524) | $ 2,290 |
Weighted average number of common shares outstanding | 71,945,743 | 71,592,089 |
Basic net income (loss) per common share | $ (0.09) | $ 0.03 |
Historical net income (loss) per share - Diluted | ||
Net income (loss) | $ (6,524) | $ 2,290 |
Weighted average number of common shares outstanding | 71,945,743 | 71,592,089 |
Effect of dilutive stock options | 2,870,789 | |
Weighted average number of common shares outstanding | 71,945,743 | 74,462,878 |
Diluted net income (loss) per common share | $ (0.09) | $ 0.03 |
Note 8 - Net Income (Loss) Pe41
Note 8 - Net Income (Loss) Per Share (Details Textual) - shares | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Earnings Per Share [Abstract] | ||
Anti-dilutive securities excluded from computation of earnings per share, Shares | 74,665 | 3,419,359 |
Note 9 - Product Lines, Conce42
Note 9 - Product Lines, Concentration of Credit Risk and Significant Customers - Percentage of Revenue by Route to Market (Details) - Sales Revenue, Product Line [Member] - Product Concentration Risk [Member] | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Segment Reporting Information [Line Items] | ||
Concentration Risk Percentage | 100.00% | 100.00% |
Pharmaceutical Wholesalers [Member] | ||
Segment Reporting Information [Line Items] | ||
Concentration Risk Percentage | 66.00% | 73.00% |
Specialty Pharmaceutical Retailers [Member] | ||
Segment Reporting Information [Line Items] | ||
Concentration Risk Percentage | 34.00% | 27.00% |
Note 9 - Product Lines, Conce43
Note 9 - Product Lines, Concentration of Credit Risk and Significant Customers (Details Textual) - Wholesaler | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Pharmaceutical Wholesalers [Member] | Product Shipments [Member] | ||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | ||
Concentration Risk, Number of Customers | 4 | 3 |
Pharmaceutical Wholesalers [Member] | Product Shipments [Member] | Customer One [Member] | ||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | ||
Concentration Risk, Percentage | 21.00% | 21.00% |
Pharmaceutical Wholesalers [Member] | Product Shipments [Member] | Customer Two [Member] | ||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | ||
Concentration Risk, Percentage | 20.00% | 19.00% |
Pharmaceutical Wholesalers [Member] | Product Shipments [Member] | Customer Three [Member] | ||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | ||
Concentration Risk, Percentage | 11.00% | 16.00% |
Pharmaceutical Wholesalers [Member] | Product Shipments [Member] | Customer Four [Member] | ||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | ||
Concentration Risk, Percentage | 10.00% | |
Pharmaceutical Wholesalers [Member] | Accounts Receivable [Member] | ||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | ||
Concentration Risk, Number of Customers | 4 | 2 |
Pharmaceutical Wholesalers [Member] | Accounts Receivable [Member] | Customer One [Member] | ||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | ||
Concentration Risk, Percentage | 28.00% | 25.00% |
Pharmaceutical Wholesalers [Member] | Accounts Receivable [Member] | Customer Two [Member] | ||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | ||
Concentration Risk, Percentage | 21.00% | 25.00% |
Pharmaceutical Wholesalers [Member] | Accounts Receivable [Member] | Customer Three [Member] | ||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | ||
Concentration Risk, Percentage | 20.00% | |
Pharmaceutical Wholesalers [Member] | Accounts Receivable [Member] | Customer Four [Member] | ||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | ||
Concentration Risk, Percentage | 16.00% | |
Pharmaceutical Retailer [Member] | Product Shipments [Member] | Customer One [Member] | ||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | ||
Concentration Risk, Percentage | 31.00% | 27.00% |
Concentration Risk, Number of Customers | 1 | 1 |
Pharmaceutical Retailer [Member] | Accounts Receivable [Member] | Customer One [Member] | ||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | ||
Concentration Risk, Number of Customers | 1 |