Document And Entity Information
Document And Entity Information - shares | 6 Months Ended | |
Jun. 30, 2016 | Jul. 29, 2016 | |
Document Information [Line Items] | ||
Entity Registrant Name | Insys Therapeutics, Inc. | |
Entity Central Index Key | 1,516,479 | |
Trading Symbol | insy | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Current Reporting Status | Yes | |
Entity Voluntary Filers | No | |
Entity Well-known Seasoned Issuer | No | |
Entity Common Stock, Shares Outstanding (in shares) | 71,595,156 | |
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2016 | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($) | Jun. 30, 2016 | Dec. 31, 2015 |
Current Assets: | ||
Cash and cash equivalents | $ 69,290,000 | $ 79,515,000 |
Short-term investments | 89,081,000 | 79,576,000 |
Accounts receivable, net of allowances of $6,590 and $7,180 at June 30, 2016 and December 31, 2015, respectively | 41,049,000 | 48,459,000 |
Inventories | 29,215,000 | 41,715,000 |
Prepaid expenses and other assets | 5,359,000 | 3,973,000 |
Total current assets | 233,994,000 | 253,238,000 |
Property and equipment, net | 39,930,000 | 38,382,000 |
Long-term investments | 35,339,000 | 43,219,000 |
Deferred income tax assets | 18,615,000 | 16,331,000 |
Other assets | 10,170,000 | 26,000 |
Total assets | 338,048,000 | 351,196,000 |
Current Liabilities: | ||
Accounts payable and accrued expenses | 22,200,000 | 36,354,000 |
Accrued compensation | 9,104,000 | 10,225,000 |
Accrued sales allowances | 30,419,000 | 32,713,000 |
Accrued litigation award | 9,567,000 | 9,567,000 |
Total current liabilities | 71,290,000 | 88,859,000 |
Uncertain income tax position | 7,471,000 | 8,635,000 |
Total liabilities | 78,761,000 | 97,494,000 |
Commitments and contingencies | ||
Stockholders' Equity: | ||
Preferred stock (par value $0.01 per share; 10,000,000 shares authorized; 0 shares issued and outstanding as of June 30, 2016 and December 31, 2015) | 0 | 0 |
Common stock (par value $0.01 per share; 100,000,000 shares authorized; 71,574,365 and 71,907,858 shares issued and outstanding as of June 30, 2016 and December 31, 2015, respectively) | 716,000 | 719,000 |
Additional paid in capital | 244,299,000 | 245,736,000 |
Unrealized gain (loss) on available-for-sale securities | 84,000 | (152,000) |
Notes receivable from stockholders | (21,000) | (21,000) |
Retained earnings | 14,209,000 | 7,420,000 |
Total stockholders' equity | 259,287,000 | 253,702,000 |
Total liabilities and stockholders' equity | $ 338,048,000 | $ 351,196,000 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Accounts receivable, allowance for doubtful accounts | $ 6,590 | $ 7,180 |
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) | 71,574,365 | 71,907,858 |
Common stock, shares outstanding (in shares) | 71,574,365 | 71,907,858 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Income and Comprehensive Income (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Net revenue | $ 67,121,000 | $ 77,633,000 | $ 129,083,000 | $ 148,403,000 |
Cost of revenue | 6,273,000 | 8,305,000 | 10,911,000 | 14,680,000 |
Gross profit | 60,848,000 | 69,328,000 | 118,172,000 | 133,723,000 |
Operating expenses: | ||||
Sales and marketing | 19,691,000 | 21,986,000 | 39,491,000 | 42,902,000 |
Research and development | 22,889,000 | 17,796,000 | 43,424,000 | 28,398,000 |
General and administrative | 13,924,000 | 15,284,000 | 28,622,000 | 28,530,000 |
Charges related to litigation award | 2,304,000 | 10,304,000 | ||
Total operating expenses | 56,504,000 | 57,370,000 | 111,537,000 | 110,134,000 |
Operating income | 4,344,000 | 11,958,000 | 6,635,000 | 23,589,000 |
Other income: | ||||
Interest income | 256,000 | 105,000 | 481,000 | 230,000 |
Other income (expense), net | (5,000) | 30,000 | 44,000 | 30,000 |
Total other income | 251,000 | 135,000 | 525,000 | 260,000 |
Income before income taxes | 4,595,000 | 12,093,000 | 7,160,000 | 23,849,000 |
Income tax expense | 240,000 | 4,779,000 | 371,000 | 8,512,000 |
Net income | 4,355,000 | 7,314,000 | 6,789,000 | 15,337,000 |
Unrealized gain on available-for-sale securities | 70,000 | (21,000) | 236,000 | 7,000 |
Total comprehensive income | $ 4,425,000 | $ 7,293,000 | $ 7,025,000 | $ 15,344,000 |
Net income per common share: | ||||
Basic (in dollars per share) | $ 0.06 | $ 0.10 | $ 0.09 | $ 0.22 |
Diluted (in dollars per share) | $ 0.06 | $ 0.10 | $ 0.09 | $ 0.20 |
Weighted average common shares outstanding | ||||
Basic (in shares) | 71,543,809 | 71,517,442 | 71,567,949 | 71,217,137 |
Diluted (in shares) | 74,053,550 | 75,478,649 | 74,281,838 | 75,255,048 |
Condensed Consolidated Stateme5
Condensed Consolidated Statement of Stockholders' Equity (Unaudited) - 6 months ended Jun. 30, 2016 - USD ($) | Common Stock [Member] | Additional Paid-in Capital [Member] | AOCI Attributable to Parent [Member] | Receivables from Stockholder [Member] | Retained Earnings [Member] | Total |
Balance (in shares) at Dec. 31, 2015 | 71,907,858 | |||||
Balance at Dec. 31, 2015 | $ 719,000 | $ 245,736,000 | $ (152,000) | $ (21,000) | $ 7,420,000 | $ 253,702,000 |
Exercise of stock options (in shares) | 376,985 | 376,985 | ||||
Exercise of stock options | $ 4,000 | 2,119,000 | $ 2,123,000 | |||
Issuance of common stock- employee stock purchase plan (in shares) | 132,597 | |||||
Issuance of common stock- employee stock purchase plan | $ 1,000 | 1,575,000 | 1,576,000 | |||
Excess tax benefits on stock options and awards | 389,000 | 389,000 | ||||
Stock based compensation - stock options and awards | 10,572,000 | 10,572,000 | ||||
Unrealized gain on available-for-sale securities | 236,000 | 236,000 | ||||
Repurchase of common stock (in shares) | (843,075) | |||||
Repurchase of common stock | $ (8,000) | (16,092,000) | (16,100,000) | |||
Net income (loss) | 6,789,000 | 6,789,000 | ||||
Balance (in shares) at Jun. 30, 2016 | 71,574,365 | |||||
Balance at Jun. 30, 2016 | $ 716,000 | $ 244,299,000 | $ 84,000 | $ (21,000) | $ 14,209,000 | $ 259,287,000 |
Condensed Consolidated Stateme6
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Cash flows from operating activities: | ||
Net income | $ 6,789,000 | $ 15,337,000 |
Adjustments to reconcile net income to net cash provided by operating activities: | ||
Depreciation and amortization | 3,023,000 | 2,457,000 |
Stock-based compensation | 10,572,000 | 7,947,000 |
Deferred income tax benefit | (2,284,000) | (1,513,000) |
Loss on disposal of assets | 41,000 | |
Excess tax benefits on stock options and awards | (389,000) | (7,416,000) |
Amortization of investment (premium) discount | 1,266,000 | 473,000 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 7,410,000 | (12,606,000) |
Inventories | 2,355,000 | (772,000) |
Prepaid expenses and other assets | (1,384,000) | (424,000) |
Accounts payable, accrued expenses and other current liabilities | (18,346,000) | 29,042,000 |
Net cash provided by operating activities | 9,012,000 | 32,566,000 |
Cash flows from investing activities: | ||
Purchase of investments | (42,398,000) | (47,419,000) |
Proceeds from sales of investments | 4,348,000 | 11,270,000 |
Proceeds from maturities of investments | 35,396,000 | 12,613,000 |
Purchases of property and equipment | (4,571,000) | (8,106,000) |
Net cash (used in) investing activities | (7,225,000) | (31,642,000) |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock | 1,576,000 | 1,478,000 |
Excess tax benefits on stock options and awards | 389,000 | 7,416,000 |
Proceeds from exercise of stock options | 2,123,000 | 6,111,000 |
Repurchase of common stock | (16,100,000) | |
Net cash (used in) provided by financing activities | (12,012,000) | 15,005,000 |
Change in cash and cash equivalents | (10,225,000) | 15,929,000 |
Cash and cash equivalents, beginning of period | 79,515,000 | 58,106,000 |
Cash and cash equivalents, end of period | 69,290,000 | 74,035,000 |
Supplemental cash flow disclosures: | ||
Cash paid for interest expense | 0 | 0 |
Cash paid for income taxes | $ 6,624,000 | $ 3,350,000 |
Note 1 - Nature of Business and
Note 1 - Nature of Business and Basis of Presentation | 6 Months Ended |
Jun. 30, 2016 | |
Notes to Financial Statements | |
Organization, Consolidation and Presentation of Financial Statements Disclosure [Text Block] | 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. 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, 2015 included in our Annual Report on Form 10-K. The results of operations for the three and six months ended June 30, 2016 and 2015 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 and 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. Recent Accounting Pronouncements In June 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2016-13 Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. The amendments 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. 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 more timely recognition of losses. We are currently evaluating the impact of this amendment on our financial statements. In May 2016, the FASB issued ASU No. 2016-12, Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients, to clarify certain core recognition principles including collectability, sales tax presentation, noncash consideration, contract modifications and completed contracts at transition and disclosures no longer required if the full retrospective transition method is adopted. The effective date and transition requirements for these amendments are the same as the effective date and transition requirements of ASU 2014-09 (discussed below). We are currently evaluating the impact of this amendment on our financial statements. In April 2016, the FASB issued ASU No. 2016-10, Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing, to clarify the following two aspects of Topic 606: 1) identifying performance obligations, and 2) the licensing implementation guidance. The effective date and transition requirements for these amendments are the same as the effective date and transition requirements of ASU 2014-09 (discussed below). We are currently evaluating the impact of this amendment on our financial statements. In March 2016, the FASB issued ASU No. 2016-09, Compensation-Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting, to reduce complexity in accounting standards involving several aspects of the accounting for employee share-based payment transactions, including (1) the income tax consequences, (2) classification of awards as either equity or liabilities, and (3) classification on the statement of cash flows. The amendments will be effective for financial statements issued for fiscal years beginning after December 15, 2016, including interim periods within those fiscal years, and early adoption is permitted. Amendments related to the timing of when excess tax benefits are recognized, minimum statutory withholding requirements, forfeitures, and intrinsic value should be applied using a modified retrospective transition, amendments related to the presentation of employee taxes paid on the statement of cash flows when an employer withholds shares to meet the minimum statutory withholding requirement should be applied retrospectively, amendments requiring recognition of excess tax benefits and tax deficiencies in the income statement and the practical expedient for estimating expected term should be applied prospectively, and amendments related to the presentation of excess tax benefits on the statement of cash flows can be applied using either a prospective transition method or a retrospective transition method. An entity that elects early adoption must adopt all of the amendments in the same period. We are currently evaluating the impact of this amendment on our financial statements. In March 2016, the FASB issued ASU No. 2016-08, Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations, to clarify the implementation guidance on principal versus agent considerations and address how an entity should assess whether it is the principal or the agent in contracts that include three or more parties. The effective date and transition requirements for these amendments are the same as the effective date and transition requirements of ASU 2014-09 (discussed below). We are currently evaluating the impact of this amendment on our 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 GAAP. 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 GAAP. 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 commence before the effective date in accordance with previous GAAP 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 GAAP. We are currently evaluating the impact of this amendment on our financial statements. 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 Accounting Standards Codification 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 this amendment on our financial statements. In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers, which will supersede nearly all existing revenue recognition guidance under U.S. GAAP. The core principle of ASU 2014-09 is to recognize revenues when promised goods or services are transferred to customers in an amount that reflects the consideration to which an entity expects to be entitled for those goods or services. ASU 2014-09 defines a five step process to achieve this core principle and, in doing so, more judgment and estimates may be required within the revenue recognition process than are required under existing U.S. GAAP. As amended by the FASB in July 2015, the standard is 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). We are currently evaluating the impact of the pending adoption of ASU 2014-09 on our consolidated financial statements and have not yet determined the method by which we will adopt the standard in 2018. In July 2015, the FASB issued guidance that requires entities to measure most inventory at the lower of cost and NRV, thereby simplifying the current guidance under which an entity must measure inventory at the lower of cost or market. Under the new guidance, inventory is measured 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 guidance is effective for annual periods beginning after December 15, 2016, and interim periods therein. Early application is permitted. We are currently evaluating the impact of adoption of this guidance on our financial position and results of operations. |
Note 2 - Revenue Recognition
Note 2 - Revenue Recognition | 6 Months Ended |
Jun. 30, 2016 | |
Notes to Financial Statements | |
Revenue Recognition [Text Block] | 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 payors 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. 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. Prompt Pay Discounts Patient Discount Programs Rebates Chargebacks. |
Note 3 - Short-term and Long-te
Note 3 - Short-term and Long-term Investments | 6 Months Ended |
Jun. 30, 2016 | |
Notes to Financial Statements | |
Investment [Text Block] | 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, as well as certificates of deposit that have maturity dates that are greater than 90 days. Certificates of deposit are carried at cost which approximates fair value. We classify our marketable securities as available-for-sale in accordance with FASB Accounting Standards Codification Topic 320, Investments — Debt and Equity Securities Investments consisted of the following at June 30, 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 $ 40,571 $ - $ - $ - $ 40,571 $ 40,571 $ - $ - Money market securities 27,964 - - - 27,964 27,964 - - Certificates of deposit 26,600 - - - 26,600 - 18,467 8,133 Marketable securities: Corporate securities 35,048 27 (6 ) - 35,069 - 26,102 8,967 Federal agency securities 16,592 3 (1 ) - 16,594 - 10,594 6,000 Municipal securities 46,851 63 (2 ) - 46,912 755 33,918 12,239 Total marketable securities 98,491 93 (9 ) - 98,575 755 70,614 27,206 ` $ 193,626 $ 93 $ (9 ) $ - $ 193,710 $ 69,290 $ 89,081 $ 35,339 Investments consisted of the following at December 31, 2015 (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 $ 55,987 $ - $ - $ - $ 55,987 $ 55,987 $ - $ - Money market securities 20,373 - - - 20,373 20,373 - - Certificates of deposit 26,223 - - - 26,223 - 16,637 9,586 Marketable securities: Corporate securities 27,186 - (68 ) - 27,118 1,621 19,181 6,316 Federal agency securities 18,823 - (65 ) - 18,758 - 10,129 8,629 Municipal securities 53,870 16 (35 ) - 53,851 1,534 33,629 18,688 Total marketable securities 99,879 16 (168 ) - 99,727 3,155 62,939 33,633 $ 202,462 $ 16 $ (168 ) $ - $ 202,310 $ 79,515 $ 79,576 $ 43,219 The amortized cost and estimated fair value of the marketable securities at June 30, 2016, by maturity, are shown below (in thousands): June 30, 2016 December 31, 2015 Amortized Cost Fair Value Amortized Cost Fair Value Marketable securities: Due in one year or less $ 71,342 $ 71,368 $ 66,148 $ 66,094 Due after one year through 5 years 27,149 27,207 33,731 33,633 Due after 5 years through 10 years - - - - Due after 10 years - - - - $ 98,491 $ 98,575 $ 99,879 $ 99,727 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 at June 30, 2016 (in thousands): June 30, 2016 December 31, 2015 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 $ 14,577 $ (6 ) $ - $ - $ 25,137 $ (68 ) $ - $ - Federal agency securities 6,566 (1 ) - - 18,759 (65 ) - - Municipal securities 8,626 (2 ) - - 22,981 (35 ) - - $ 29,769 $ (9 ) $ - $ - $ 66,877 $ (168 ) $ - $ - As of June 30, 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 | 6 Months Ended |
Jun. 30, 2016 | |
Notes to Financial Statements | |
Fair Value Disclosures [Text Block] | 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 June 30, 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. Our Level 2 assets consist of available-for-sale securities that are valued utilizing reports from third-party asset managers that hold our investments, showing closing prices on the last business day of the period presented. 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. In addition, we use an independent third-party to perform price testing, comparing a sample of quoted prices listed in the asset managers’ reports to quotes listed through a public quotation service. Our Level 3 asset represents a long-term corporate convertible promissory note and a warrant to purchase shares issued in connection with the convertible promissory note. The note is not listed on any security exchange. The fair value of the convertible promissory note and warrant approximate their carrying values at June 30, 2016. Our investments measured at fair value on a recurring basis subject to the disclosure requirements of ASC 820 at June 30, 2016 and December 31, 2015 were as follows (in thousands): Fair Value Measurement at Reporting Date June 30, 2016 Quoted Prices in active Markets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Marketable securities: Corporate securities $ 35,069 $ - $ 34,569 $ 500 Federal agency securities 16,594 - 16,594 - Municipal securities 46,912 - 46,912 - Total assets measured at fair value $ 98,575 $ - $ 98,075 $ 500 Fair Value Measurement at Reporting Date December 31, 2015 Quoted Prices in active Markets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Marketable securities: Corporate securities $ 27,118 $ - $ 27,118 $ - Federal agency securities 18,758 - 18,758 - Municipal securities 53,851 - 53,851 - Total assets measured at fair value $ 99,727 $ - $ 99,727 $ - 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 (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2016 2015 2016 2015 Convertible note Balance, beginning of period $ - $ - $ - $ - Change in fair value - - - - Purchases 500 - 500 - Balance, end of period $ 500 $ - $ 500 $ - |
Note 5 - Inventories
Note 5 - Inventories | 6 Months Ended |
Jun. 30, 2016 | |
Notes to Financial Statements | |
Inventory Disclosure [Text Block] | 5. Inventories Inventories are stated at lower of cost or market. Cost, which includes amounts related to materials and costs incurred by our contract manufacturers, is determined on a first-in, first-out basis. Inventories are reviewed periodically for potential excess, dated or obsolete status. Management evaluates the carrying value of inventories on a regular basis, taking into account such factors as historical and anticipated future sales compared to quantities on hand, the price we expect to obtain for products in their respective markets compared with historical cost and the remaining shelf life of goods on hand. The components of inventories, net of allowances, are as follows (in thousands): June 30, 2016 December 31, 2015 Finished goods $ 14,200 $ 28,216 Work-in-process 7,128 7,018 Raw materials and supplies 7,887 6,481 Total inventories 29,215 41,715 Plus: non-current finished goods 10,145 - $ 39,360 $ 41,715 As of June 30, 2016 and December 31, 2015, 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 finished goods represent those inventories not expected to be sold within 12 months of the balance sheet date and are included in other assets in our condensed consolidated unaudited balance sheets. As of June 30, 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 net realizable value. Inventory at June 30, 2016 and December 31, 2015 were reported net of these reserves of $1.4 million and $0.1 million, respectively. |
Note 6 - Commitments and Contin
Note 6 - Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2016 | |
Notes to Financial Statements | |
Commitments and Contingencies Disclosure [Text Block] | 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. As legal and governmental proceedings are inherently unpredictable and, in part, beyond our control, unless otherwise indicated, we cannot currently 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. A future adverse outcome in any of these proceedings could have a material adverse effect on our business, financial condition, results of operations and cash flows, and could cause the market value of our common stock to decline. 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 which we believe are potentially material at this time. It is possible that criminal charges and substantial payments, fines and/or civil penalties or damages could result from any government investigation or proceeding, as well as a corporate integrity agreement or similar government mandated compliance document, whether we deem an investigation to be material or not at this time. Department of Health and Human Services Investigation. HIPPA 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. 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 regards to two Alabama health care professionals who prescribed our product Subsys. Those two Alabama health care professionals 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. We continue to assess these matters to ensure we have an effective compliance program. State Related Investigations. In connection with the investigation by the ODOJ we have entered into a settlement agreement with the ODOJ referred to as an AVC, and have 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. Investigations of Physicians. Opioid Litigation With the exception of the ODOJ investigation which we have quantified above, we believe a loss from an unfavorable outcome of these 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 shareholders 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 On or about February 2, 2016, a complaint (captioned Richard Di Donato v. Insys Therapeutics, Inc., Case 2:16-cv-00302-NVW) was filed in the Arizona District Court, against us and certain of our current and former officers. This 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 federal securities laws by making intentionally false and misleading statements regarding our business and operations, therefore artificially inflating the price of our common stock. The plaintiffs seek unspecified monetary damages and other relief. We intend to vigorously defend this claim. General Litigation and Disputes Kottayil vs. Insys Pharma, Inc. 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 June 30, 2016, including $2,249,000 of estimated pre-and post-judgement interest. The final outcome of the appeal could cause the estimates 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 for 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. As of August 1, 2016, Plaintiffs have filed opening and reply and cross response briefs and we have filed our answering and cross-appeal brief and our reply in support of our cross-appeal. We intend to request an oral argument, after which the court may set a hearing date. Except as it pertains to the $9,567,000 accrued for the dispute with Dr. Kottayil and the potential for damages in the Federal Securities litigation that we believe should be sufficiently covered by our director and officers insurance policies (once we have met any applicable retainage requirement under the applicable policy), we believe that the probability of unfavorable outcome or loss related to all of the above litigation matters and an estimate of the amount or range of loss, if any, from an unfavorable outcome are not determinable at this time. We believe we have meritorious legal positions and will continue to represent our interests vigorously in these matters but the range possible outcomes on these matters is very broad and we are not able to provide a reasonable estimate of our potential liability, if any, nor are we able to predict the outcome of each litigation matter. Responding to each of these litigation matters, defending any claims raised, and any resulting fines, restitution, damages and penalties, or settlement payments as well as any related actions brought by shareholders or other third parties, could have a material impact on our reputation, business and financial condition and divert the attention of our management from operating our business. Wayne Automatic Fire Sprinklers Markland. Material Agreements In April 2015, we entered into an amendment to our manufacturing and supply agreement with DPT, which extends our existing manufacturing and supply agreement to produce Subsys until the end of 2020. In addition to extending the term, this amendment added certain minimum purchase commitments. In October 2015, we entered into an amended and restated supply, development & exclusive licensing agreement with Aptar which, among other things, extended our exclusive supply rights to the current sublingual device, currently utilized by Subsys, as well any new device(s) jointly developed by the two companies for a period of seven years. In addition to extending the term, this amendment added certain minimum purchase commitments and requires certain tiered royalties as a percentage of net revenue to be paid by us ranging from less than one percent to the low single digits, commencing in March 2016 through the term of this agreement, from our sales of Subsys and future products that use the Aptar spray device technology. In January 2016, we assigned our rights, title, duties and obligations of our manufacturing and supply agreement with DPT and our supply, development & exclusive licensing agreement with Aptar from our parent to our manufacturing subsidiary as part of a corporate restructuring. In July 2016, we, through our manufacturing subsidiary, entered into a further amendment to our DPT manufacturing and supply agreement dated May 24, 2011. This amendment effectively eliminates any prior minimum purchase (and batch) obligations that had been set forth in this agreement and replaces it with a new annual purchase commitment of $4,000,000 per calendar year commencing January 1, 2017 through December 31, 2020. As a result, the cumulative effect related to this amendment reduces our aggregated minimum purchase commitments with DPT from $49,740,000 to $16,000,000. 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 2016 1,790 2017 6,000 2018 7,500 2019 8,410 2020 8,550 Thereafter 4,330 Total $ 36,580 |
Note 7 - Stock-based Compensati
Note 7 - Stock-based Compensation | 6 Months Ended |
Jun. 30, 2016 | |
Notes to Financial Statements | |
Disclosure of Compensation Related Costs, Share-based Payments [Text Block] | 7. Stock-based Compensation Amounts recognized in the condensed consolidated statements of income and comprehensive income with respect to our stock-based compensation plans were as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2016 2015 2016 2015 Research and development $ 1,063 $ 448 $ 3,424 $ 789 General and administrative 3,883 3,779 7,148 7,158 Total cost of stock-based compensation $ 4,946 $ 4,227 $ 10,572 $ 7,947 As of June 30, 2016, we expected to recognize $48,200,100 of stock-based compensation for outstanding options over a weighted-average period of 3.0 years. The following table summarizes stock option activity as of December 31, 2015 and for the six months ended June 30, 2016: 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, 2015 3,772,736 $ 6.91 Outstanding as of December 31, 2015 7,138,089 $ 12.33 Granted 2,124,393 $ 14.91 Cancelled (435,423 ) $ 16.90 Exercised (376,985 ) $ 5.63 Outstanding as of June 30, 2016 8,450,074 $ 13.04 7.9 $ 32.4 Vested and exercisable as of June 30, 2016 4,131,635 $ 8.40 6.7 $ 28.1 Cash received from option exercises under all share-based payment arrangements for the six months ended June 30, 2016 and 2015 was $2,123,000 and $6,111,000, respectively. For the six months ended June 30, 2016 and 2015, we recorded net reductions of $389,000 and $7,416,000, respectively, 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. |
Note 8 - Net Income Per Share
Note 8 - Net Income Per Share | 6 Months Ended |
Jun. 30, 2016 | |
Notes to Financial Statements | |
Earnings Per Share [Text Block] | 8. Net Income per Share Basic net income 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 per common share (dollars in thousands, except per share amounts): Three Months Ended Six Months Ended June 30, June 30, 2016 2015 2016 2015 Historical net income per share - Basic Numerator: Net income $ 4,355 $ 7,314 $ 6,789 $ 15,337 Denominator: Weighted average number of common shares outstanding 71,543,809 71,517,442 71,567,949 71,217,137 Basic net income per common share $ 0.06 $ 0.10 $ 0.09 $ 0.22 Historical net income per share - Diluted Numerator: Net income $ 4,355 $ 7,314 $ 6,789 $ 15,337 Denominator: Weighted average number of common shares outstanding 71,543,809 71,517,442 71,567,949 71,217,137 Effect of dilutive stock options 2,509,741 3,961,207 2,713,889 4,037,911 Weighted average number of common shares outstanding 74,053,550 75,478,649 74,281,838 75,255,048 Diluted net income per common share $ 0.06 $ 0.10 $ 0.09 $ 0.20 Anti-dilutive share equivalents included 5,067,070 and 1,274,490 outstanding stock options as of June 30, 2016 and 2015, respectively. |
Note 9 - Product Lines, Concent
Note 9 - Product Lines, Concentration of Credit Risk and Significant Customers | 6 Months Ended |
Jun. 30, 2016 | |
Notes to Financial Statements | |
Concentration Risk Disclosure [Text Block] | 9. Product Lines, Concentration of Credit Risk and Significant Customers We are engaged in the business of developing and selling pharmaceutical products. In 2016, we have one product line, Subsys. Our chief operating decision-maker evaluates revenues based on product lines. The following tables summarize our net revenue by product line, as well as the percentages of revenue by route to market (in thousands): Net Revenue by Product Line Three Months Ended June 30, Six Months Ended June 30, 2016 2015 2016 2015 Subsys $ 67,121 $ 76,700 $ 129,083 $ 147,240 Dronabinol SG Capsule - 933 - 1,163 Total net revenue $ 67,121 $ 77,633 $ 129,083 $ 148,403 Percent of Revenue by Route to Market Three Months Ended June 30, Six Months Ended June 30, 2016 2015 2016 2015 Pharmaceutical wholesalers 69 % 99 % 71 % 99 % Specialty pharmaceutical retailers 31 % 1 % 29 % 1 % 100 % 100 % 100 % 100 % All our products are sold in the United States of America. Product shipments to four pharmaceutical wholesalers accounted for 18%, 17%, 16%, and 13% of total shipments and product shipments to one specialty pharmaceutical retailer accounted for 29% of total shipments for the six months ended June 30, 2016. Product shipments to four pharmaceutical wholesalers accounted for 33%, 20%, 18% and 15% of total shipments for the six months ended June 30, 2015. Four pharmaceutical wholesalers’ accounts receivable balances accounted for 23%, 18%, 15%, and 14% of gross accounts receivable and one specialty pharmaceutical retailers’ accounts receivable balance accounted for 20% of gross accounts receivable balance as of June 30, 2016. Four pharmaceutical wholesalers’ accounts receivable balances accounted for 35%, 20%, 18% and 12% of gross accounts receivable as of June 30, 2015. |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2016 | |
Accounting Policies [Abstract] | |
New Accounting Pronouncements, Policy [Policy Text Block] | Recent Accounting Pronouncements In June 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2016-13 Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. The amendments 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. 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 more timely recognition of losses. We are currently evaluating the impact of this amendment on our financial statements. In May 2016, the FASB issued ASU No. 2016-12, Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients, to clarify certain core recognition principles including collectability, sales tax presentation, noncash consideration, contract modifications and completed contracts at transition and disclosures no longer required if the full retrospective transition method is adopted. The effective date and transition requirements for these amendments are the same as the effective date and transition requirements of ASU 2014-09 (discussed below). We are currently evaluating the impact of this amendment on our financial statements. In April 2016, the FASB issued ASU No. 2016-10, Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing, to clarify the following two aspects of Topic 606: 1) identifying performance obligations, and 2) the licensing implementation guidance. The effective date and transition requirements for these amendments are the same as the effective date and transition requirements of ASU 2014-09 (discussed below). We are currently evaluating the impact of this amendment on our financial statements. In March 2016, the FASB issued ASU No. 2016-09, Compensation-Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting, to reduce complexity in accounting standards involving several aspects of the accounting for employee share-based payment transactions, including (1) the income tax consequences, (2) classification of awards as either equity or liabilities, and (3) classification on the statement of cash flows. The amendments will be effective for financial statements issued for fiscal years beginning after December 15, 2016, including interim periods within those fiscal years, and early adoption is permitted. Amendments related to the timing of when excess tax benefits are recognized, minimum statutory withholding requirements, forfeitures, and intrinsic value should be applied using a modified retrospective transition, amendments related to the presentation of employee taxes paid on the statement of cash flows when an employer withholds shares to meet the minimum statutory withholding requirement should be applied retrospectively, amendments requiring recognition of excess tax benefits and tax deficiencies in the income statement and the practical expedient for estimating expected term should be applied prospectively, and amendments related to the presentation of excess tax benefits on the statement of cash flows can be applied using either a prospective transition method or a retrospective transition method. An entity that elects early adoption must adopt all of the amendments in the same period. We are currently evaluating the impact of this amendment on our financial statements. In March 2016, the FASB issued ASU No. 2016-08, Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations, to clarify the implementation guidance on principal versus agent considerations and address how an entity should assess whether it is the principal or the agent in contracts that include three or more parties. The effective date and transition requirements for these amendments are the same as the effective date and transition requirements of ASU 2014-09 (discussed below). We are currently evaluating the impact of this amendment on our 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 GAAP. 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 GAAP. 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 commence before the effective date in accordance with previous GAAP 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 GAAP. We are currently evaluating the impact of this amendment on our financial statements. 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 Accounting Standards Codification 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 this amendment on our financial statements. In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers, which will supersede nearly all existing revenue recognition guidance under U.S. GAAP. The core principle of ASU 2014-09 is to recognize revenues when promised goods or services are transferred to customers in an amount that reflects the consideration to which an entity expects to be entitled for those goods or services. ASU 2014-09 defines a five step process to achieve this core principle and, in doing so, more judgment and estimates may be required within the revenue recognition process than are required under existing U.S. GAAP. As amended by the FASB in July 2015, the standard is 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). We are currently evaluating the impact of the pending adoption of ASU 2014-09 on our consolidated financial statements and have not yet determined the method by which we will adopt the standard in 2018. In July 2015, the FASB issued guidance that requires entities to measure most inventory at the lower of cost and NRV, thereby simplifying the current guidance under which an entity must measure inventory at the lower of cost or market. Under the new guidance, inventory is measured 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 guidance is effective for annual periods beginning after December 15, 2016, and interim periods therein. Early application is permitted. We are currently evaluating the impact of adoption of this guidance on our financial position and results of operations. |
Note 3 - Short-term and Long-17
Note 3 - Short-term and Long-term Investments (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Notes Tables | |
Available-for-sale Securities [Table Text Block] | Cost Unrealized Gains Unrealized Losses Other- Than- Temporary Impairment Losses Fair Value Cash and Cash Equivalents Short-term Investments Long-term Investments Cash $ 40,571 $ - $ - $ - $ 40,571 $ 40,571 $ - $ - Money market securities 27,964 - - - 27,964 27,964 - - Certificates of deposit 26,600 - - - 26,600 - 18,467 8,133 Marketable securities: Corporate securities 35,048 27 (6 ) - 35,069 - 26,102 8,967 Federal agency securities 16,592 3 (1 ) - 16,594 - 10,594 6,000 Municipal securities 46,851 63 (2 ) - 46,912 755 33,918 12,239 Total marketable securities 98,491 93 (9 ) - 98,575 755 70,614 27,206 ` $ 193,626 $ 93 $ (9 ) $ - $ 193,710 $ 69,290 $ 89,081 $ 35,339 Cost Unrealized Gains Unrealized Losses Other- Than- Temporary Impairment Losses Fair Value Cash and Cash Equivalents Short-term Investments Long-term Investments Cash $ 55,987 $ - $ - $ - $ 55,987 $ 55,987 $ - $ - Money market securities 20,373 - - - 20,373 20,373 - - Certificates of deposit 26,223 - - - 26,223 - 16,637 9,586 Marketable securities: Corporate securities 27,186 - (68 ) - 27,118 1,621 19,181 6,316 Federal agency securities 18,823 - (65 ) - 18,758 - 10,129 8,629 Municipal securities 53,870 16 (35 ) - 53,851 1,534 33,629 18,688 Total marketable securities 99,879 16 (168 ) - 99,727 3,155 62,939 33,633 $ 202,462 $ 16 $ (168 ) $ - $ 202,310 $ 79,515 $ 79,576 $ 43,219 |
Schedule of Available-for-sale Securities Reconciliation [Table Text Block] | June 30, 2016 December 31, 2015 Amortized Cost Fair Value Amortized Cost Fair Value Marketable securities: Due in one year or less $ 71,342 $ 71,368 $ 66,148 $ 66,094 Due after one year through 5 years 27,149 27,207 33,731 33,633 Due after 5 years through 10 years - - - - Due after 10 years - - - - $ 98,491 $ 98,575 $ 99,879 $ 99,727 |
Schedule of Unrealized Loss on Investments [Table Text Block] | June 30, 2016 December 31, 2015 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 $ 14,577 $ (6 ) $ - $ - $ 25,137 $ (68 ) $ - $ - Federal agency securities 6,566 (1 ) - - 18,759 (65 ) - - Municipal securities 8,626 (2 ) - - 22,981 (35 ) - - $ 29,769 $ (9 ) $ - $ - $ 66,877 $ (168 ) $ - $ - |
Note 4 - Fair Value Measureme18
Note 4 - Fair Value Measurement (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Notes Tables | |
Fair Value, Assets Measured on Recurring Basis [Table Text Block] | Fair Value Measurement at Reporting Date June 30, 2016 Quoted Prices in active Markets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Marketable securities: Corporate securities $ 35,069 $ - $ 34,569 $ 500 Federal agency securities 16,594 - 16,594 - Municipal securities 46,912 - 46,912 - Total assets measured at fair value $ 98,575 $ - $ 98,075 $ 500 Fair Value Measurement at Reporting Date December 31, 2015 Quoted Prices in active Markets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Marketable securities: Corporate securities $ 27,118 $ - $ 27,118 $ - Federal agency securities 18,758 - 18,758 - Municipal securities 53,851 - 53,851 - Total assets measured at fair value $ 99,727 $ - $ 99,727 $ - |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Table Text Block] | Three Months Ended June 30, Six Months Ended June 30, 2016 2015 2016 2015 Convertible note Balance, beginning of period $ - $ - $ - $ - Change in fair value - - - - Purchases 500 - 500 - Balance, end of period $ 500 $ - $ 500 $ - |
Note 5 - Inventories (Tables)
Note 5 - Inventories (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Notes Tables | |
Schedule of Inventory, Current [Table Text Block] | June 30, 2016 December 31, 2015 Finished goods $ 14,200 $ 28,216 Work-in-process 7,128 7,018 Raw materials and supplies 7,887 6,481 Total inventories 29,215 41,715 Plus: non-current finished goods 10,145 - $ 39,360 $ 41,715 |
Note 6 - Commitments and Cont20
Note 6 - Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Notes Tables | |
Long-term Purchase Commitment [Table Text Block] | Years ending December 31, Remainder of 2016 1,790 2017 6,000 2018 7,500 2019 8,410 2020 8,550 Thereafter 4,330 Total $ 36,580 |
Note 7 - Stock-based Compensa21
Note 7 - Stock-based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Notes Tables | |
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Table Text Block] | Three Months Ended June 30, Six Months Ended June 30, 2016 2015 2016 2015 Research and development $ 1,063 $ 448 $ 3,424 $ 789 General and administrative 3,883 3,779 7,148 7,158 Total cost of stock-based compensation $ 4,946 $ 4,227 $ 10,572 $ 7,947 |
Schedule of Share-based Compensation, Stock Options, Activity [Table Text Block] | 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, 2015 3,772,736 $ 6.91 Outstanding as of December 31, 2015 7,138,089 $ 12.33 Granted 2,124,393 $ 14.91 Cancelled (435,423 ) $ 16.90 Exercised (376,985 ) $ 5.63 Outstanding as of June 30, 2016 8,450,074 $ 13.04 7.9 $ 32.4 Vested and exercisable as of June 30, 2016 4,131,635 $ 8.40 6.7 $ 28.1 |
Note 8 - Net Income Per Share (
Note 8 - Net Income Per Share (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Notes Tables | |
Schedule of Earnings Per Share, Basic and Diluted [Table Text Block] | Three Months Ended Six Months Ended June 30, June 30, 2016 2015 2016 2015 Historical net income per share - Basic Numerator: Net income $ 4,355 $ 7,314 $ 6,789 $ 15,337 Denominator: Weighted average number of common shares outstanding 71,543,809 71,517,442 71,567,949 71,217,137 Basic net income per common share $ 0.06 $ 0.10 $ 0.09 $ 0.22 Historical net income per share - Diluted Numerator: Net income $ 4,355 $ 7,314 $ 6,789 $ 15,337 Denominator: Weighted average number of common shares outstanding 71,543,809 71,517,442 71,567,949 71,217,137 Effect of dilutive stock options 2,509,741 3,961,207 2,713,889 4,037,911 Weighted average number of common shares outstanding 74,053,550 75,478,649 74,281,838 75,255,048 Diluted net income per common share $ 0.06 $ 0.10 $ 0.09 $ 0.20 |
Note 9 - Product Lines, Conce23
Note 9 - Product Lines, Concentration of Credit Risk and Significant Customers (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Notes Tables | |
Revenue from External Customers by Products and Services [Table Text Block] | Net Revenue by Product Line Three Months Ended June 30, Six Months Ended June 30, 2016 2015 2016 2015 Subsys $ 67,121 $ 76,700 $ 129,083 $ 147,240 Dronabinol SG Capsule - 933 - 1,163 Total net revenue $ 67,121 $ 77,633 $ 129,083 $ 148,403 |
Schedules of Concentration of Risk, by Risk Factor [Table Text Block] | Percent of Revenue by Route to Market Three Months Ended June 30, Six Months Ended June 30, 2016 2015 2016 2015 Pharmaceutical wholesalers 69 % 99 % 71 % 99 % Specialty pharmaceutical retailers 31 % 1 % 29 % 1 % 100 % 100 % 100 % 100 % |
Note 1 - Nature of Business a24
Note 1 - Nature of Business and Basis of Presentation (Details Textual) | 6 Months Ended |
Jun. 30, 2016 | |
Subsys [Member] | |
Number of Product Lines | 1 |
Note 2 - Revenue Recognition (D
Note 2 - Revenue Recognition (Details Textual) | 6 Months Ended |
Jun. 30, 2016 | |
Subsys [Member] | |
Product Return, Period Prior to Expiration | 180 days |
Product Return, Period After Expiration | 1 year |
Shelf Life of Product from Date of Manufacture | 3 years |
Cash Discount, Percent | 2.00% |
Note 3 - Short-term and Long-26
Note 3 - Short-term and Long-term Investments (Details Textual) - USD ($) | Jun. 30, 2016 | Dec. 31, 2015 |
Cash and Cash Equivalents [Member] | ||
Investment Owned, at Fair Value | $ 755,000 | |
Short-term Investments [Member] | ||
Investment Owned, at Fair Value | 89,081,000 | |
Other Long-term Investments [Member] | ||
Investment Owned, at Fair Value | 35,339,000 | |
Investment Owned, at Fair Value | $ 193,710,000 | $ 202,310,000 |
Note 3 - Short-term and Long-27
Note 3 - Short-term and Long-term Investments - Summary of Investments (Details) - USD ($) | Jun. 30, 2016 | Dec. 31, 2015 | Jun. 30, 2015 | Dec. 31, 2014 |
Cash [Member] | ||||
Amortized Cost | $ 40,571,000 | $ 55,987,000 | ||
Investment Owned, at Fair Value | 40,571,000 | 55,987,000 | ||
Cash and Cash Equivalents | 40,571,000 | 55,987,000 | ||
Money Market Funds [Member] | ||||
Amortized Cost | 27,964,000 | 20,373,000 | ||
Investment Owned, at Fair Value | 27,964,000 | 20,373,000 | ||
Cash and Cash Equivalents | 27,964,000 | 20,373,000 | ||
Certificates of Deposit [Member] | ||||
Amortized Cost | 26,600,000 | 26,223,000 | ||
Investment Owned, at Fair Value | 26,600,000 | 26,223,000 | ||
Short-term Investments | 18,467,000 | 16,637,000 | ||
Long-term Investments | 8,133,000 | 9,586,000 | ||
Corporate Debt Securities [Member] | ||||
Amortized Cost | 35,048,000 | 27,186,000 | ||
Investment Owned, at Fair Value | 35,069,000 | 27,118,000 | ||
Cash and Cash Equivalents | 1,621,000 | |||
Short-term Investments | 26,102,000 | 19,181,000 | ||
Long-term Investments | 8,967,000 | 6,316,000 | ||
Unrealized Gains | 27,000 | |||
Unrealized Losses | (6,000) | (68,000) | ||
US Government Agencies Debt Securities [Member] | ||||
Amortized Cost | 16,592,000 | 18,823,000 | ||
Investment Owned, at Fair Value | 16,594,000 | 18,758,000 | ||
Short-term Investments | 10,594,000 | 10,129,000 | ||
Long-term Investments | 6,000,000 | 8,629,000 | ||
Unrealized Gains | 3,000 | |||
Unrealized Losses | (1,000) | (65,000) | ||
Municipal Bonds [Member] | ||||
Amortized Cost | 46,851,000 | 53,870,000 | ||
Investment Owned, at Fair Value | 46,912,000 | 53,851,000 | ||
Cash and Cash Equivalents | 755,000 | 1,534,000 | ||
Short-term Investments | 33,918,000 | 33,629,000 | ||
Long-term Investments | 12,239,000 | 18,688,000 | ||
Unrealized Gains | 63,000 | 16,000 | ||
Unrealized Losses | (2,000) | (35,000) | ||
Marketable Securities [Member] | ||||
Amortized Cost | 98,491,000 | 99,879,000 | ||
Investment Owned, at Fair Value | 98,575,000 | 99,727,000 | ||
Cash and Cash Equivalents | 755,000 | 3,155,000 | ||
Short-term Investments | 70,614,000 | 62,939,000 | ||
Long-term Investments | 27,206,000 | 33,633,000 | ||
Unrealized Gains | 93,000 | 16,000 | ||
Unrealized Losses | (9,000) | (168,000) | ||
Amortized Cost | 193,626,000 | 202,462,000 | ||
Investment Owned, at Fair Value | 193,710,000 | 202,310,000 | ||
Cash and Cash Equivalents | 69,290,000 | 79,515,000 | $ 74,035,000 | $ 58,106,000 |
Short-term Investments | 89,081,000 | 79,576,000 | ||
Long-term Investments | 35,339,000 | 43,219,000 | ||
Unrealized Gains | 93,000 | 16,000 | ||
Unrealized Losses | $ (9,000) | $ (168,000) |
Note 3 - Short-term and Long-28
Note 3 - Short-term and Long-term Investments - Amortized Cost and Estimated Fair Value of Securities (Details) - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Marketable securities: | ||
Due in one year or less | $ 71,342 | $ 66,148 |
Due in one year or less | 71,368 | 66,094 |
Due after one year through 5 years | 27,149 | 33,731 |
Due after one year through 5 years | 27,207 | 33,633 |
Due after 5 years through 10 years | ||
Due after 5 years through 10 years | ||
Due after 10 years | ||
Due after 10 years | ||
Total | 98,491 | 99,879 |
Total | $ 98,575 | $ 99,727 |
Note 3 - Short-term and Long-29
Note 3 - Short-term and Long-term Investments - Gross Unrealized Losses (Details) - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Corporate Bond Securities [Member] | ||
Marketable securities: | ||
Less Than 12 Months Fair Value | $ 14,577 | $ 25,137 |
Less Than 12 Months Unrealized Loss | (6) | (68) |
Greater Than 12 Months Fair Value | ||
Greater Than 12 Months Unrealized Loss | ||
US Government Agencies Debt Securities [Member] | ||
Marketable securities: | ||
Less Than 12 Months Fair Value | 6,566 | 18,759 |
Less Than 12 Months Unrealized Loss | (1) | (65) |
Greater Than 12 Months Fair Value | ||
Greater Than 12 Months Unrealized Loss | ||
Municipal Bonds [Member] | ||
Marketable securities: | ||
Less Than 12 Months Fair Value | 8,626 | 22,981 |
Less Than 12 Months Unrealized Loss | (2) | (35) |
Greater Than 12 Months Fair Value | ||
Greater Than 12 Months Unrealized Loss | ||
Less Than 12 Months Fair Value | 29,769 | 66,877 |
Less Than 12 Months Unrealized Loss | (9) | (168) |
Greater Than 12 Months Fair Value | ||
Greater Than 12 Months Unrealized Loss |
Note 4 - Fair Value Measureme30
Note 4 - Fair Value Measurement - Investments Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Corporate Debt Securities [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Available-for-sale securities | ||
Corporate Debt Securities [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Available-for-sale securities | 34,569 | 27,118 |
Corporate Debt Securities [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Available-for-sale securities | 500 | |
Corporate Debt Securities [Member] | ||
Available-for-sale securities | 35,069 | 27,118 |
US Government Agencies Debt Securities [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Available-for-sale securities | ||
US Government Agencies Debt Securities [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Available-for-sale securities | 16,594 | 18,758 |
US Government Agencies Debt Securities [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Available-for-sale securities | ||
US Government Agencies Debt Securities [Member] | ||
Available-for-sale securities | 16,594 | 18,758 |
Municipal Bonds [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Available-for-sale securities | ||
Municipal Bonds [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Available-for-sale securities | 46,912 | 53,851 |
Municipal Bonds [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Available-for-sale securities | ||
Municipal Bonds [Member] | ||
Available-for-sale securities | 46,912 | 53,851 |
Fair Value, Inputs, Level 1 [Member] | ||
Available-for-sale securities | ||
Fair Value, Inputs, Level 2 [Member] | ||
Available-for-sale securities | 98,075 | 99,727 |
Fair Value, Inputs, Level 3 [Member] | ||
Available-for-sale securities | 500 | |
Available-for-sale securities | $ 98,575 | $ 99,727 |
Note 4 - Fair Value Measureme31
Note 4 - Fair Value Measurement - Additional Information about Assets Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Balance, beginning of period | ||||
Change in fair value | ||||
Purchases | 0.5 | 0.5 | ||
Balance, end of period | $ 0.5 | $ 0.5 |
Note 5 - Inventories (Details T
Note 5 - Inventories (Details Textual) - USD ($) $ in Millions | Jun. 30, 2016 | Dec. 31, 2015 |
Inventory Valuation Reserves | $ 1.4 | $ 0.1 |
Note 5 - Inventories - Componen
Note 5 - Inventories - Components of Inventories (Details) - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Finished goods | $ 14,200 | $ 28,216 |
Work-in-process | 7,128 | 7,018 |
Raw materials and supplies | 7,887 | 6,481 |
Total inventories | 29,215 | 41,715 |
Plus: non-current finished goods | 10,145 | |
Inventories, net | $ 39,360 | $ 41,715 |
Note 6 - Commitments and Cont34
Note 6 - Commitments and Contingencies (Details Textual) - USD ($) | Jul. 14, 2016 | Jan. 26, 2016 | Nov. 01, 2015 | Oct. 30, 2015 | Oct. 02, 2015 | Jun. 23, 2015 | Jun. 08, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | Dec. 31, 2015 |
Anti-Kickback Statute Litigation [Member] | Settled Litigation [Member] | ||||||||||||
Payments In Question | $ 83,000 | |||||||||||
Oregon Department of Justice [Member] | Settled Litigation [Member] | ||||||||||||
Litigation Settlement, Amount | $ 1,100,000 | |||||||||||
Kottayil vs. Insys Pharma, Inc. [Member] | Settled Litigation [Member] | Settlement Interest [Member] | ||||||||||||
Estimated Litigation Liability | $ 2,249,000 | $ 2,249,000 | ||||||||||
Kottayil vs. Insys Pharma, Inc. [Member] | Settled Litigation [Member] | ||||||||||||
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 Litigation Liability | 9,567,000 | 9,567,000 | ||||||||||
Kottayil vs. Insys Pharma, Inc. [Member] | Threatened Litigation [Member] | Minimum [Member] | ||||||||||||
Loss Contingency, Estimate of Possible Loss | $ 0 | |||||||||||
Kottayil vs. Insys Pharma, Inc. [Member] | Threatened Litigation [Member] | Maximum [Member] | ||||||||||||
Loss Contingency, Estimate of Possible Loss | 3,630,000 | |||||||||||
Kottayil vs. Insys Pharma, Inc. [Member] | Threatened Litigation [Member] | ||||||||||||
Loss Contingency, Damages Sought, Value | $ 3,630,000 | |||||||||||
Wayne Automatic Fire Sprinklers [Member] | Threatened Litigation [Member] | Minimum [Member] | ||||||||||||
Loss Contingency, Damages Sought, Value | $ 75,000 | |||||||||||
Subsequent Event [Member] | DPT [Member] | ||||||||||||
Purchase Obligation Per Calendar Year | $ 4,000,000 | |||||||||||
Purchase Obligation | $ 16,000,000 | |||||||||||
DPT [Member] | ||||||||||||
Purchase Obligation | 49,740,000 | 49,740,000 | ||||||||||
Litigation Settlement, Expense | $ 2,304,000 | $ 10,304,000 | ||||||||||
Term of Aptargroup, Inc Joint Agreement | 7 years | |||||||||||
Purchase Obligation | $ 36,580,000 | $ 36,580,000 |
Note 6 - Commitments and Cont35
Note 6 - Commitments and Contingencies - Future Minimum Purchase Commitments (Details) $ in Thousands | Jun. 30, 2016USD ($) |
Years ending December 31, | |
Remainder of 2016 | $ 1,790 |
2,017 | 6,000 |
2,018 | 7,500 |
2,019 | 8,410 |
2,020 | 8,550 |
Thereafter | 4,330 |
Total | $ 36,580 |
Note 7 - Stock-based Compensa36
Note 7 - Stock-based Compensation (Details Textual) - USD ($) | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Stock Options | $ 48,200,100 | |
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 3 years | |
Proceeds from Stock Options Exercised | $ 2,123,000 | $ 6,111,000 |
Employee Service Share-based Compensation, Tax Benefit from Compensation Expense | $ 389,000 | $ 7,416,000 |
Note 7 - Stock-based Compensa37
Note 7 - Stock-based Compensation - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Research and Development Expense [Member] | ||||
Allocated share-based compensation expense | $ 1,063 | $ 448 | $ 3,424 | $ 789 |
General and Administrative Expense [Member] | ||||
Allocated share-based compensation expense | 3,883 | 3,779 | 7,148 | 7,158 |
Allocated share-based compensation expense | $ 4,946 | $ 4,227 | $ 10,572 | $ 7,947 |
Note 7 - Stock-based Compensa38
Note 7 - Stock-based Compensation - Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Millions | 6 Months Ended | |
Jun. 30, 2016 | Dec. 31, 2015 | |
Vested and exercisable as of December 31, 2015 (in shares) | 4,131,635 | 3,772,736 |
Vested and exercisable as of December 31, 2015 (in dollars per share) | $ 8.40 | $ 6.91 |
Outstanding (in shares) | 7,138,089 | |
Outstanding (in dollars per share) | $ 12.33 | |
Granted (in shares) | 2,124,393 | |
Granted (in dollars per share) | $ 14.91 | |
Cancelled (in shares) | (435,423) | |
Cancelled (in dollars per share) | $ 16.90 | |
Exercised (in shares) | (376,985) | |
Exercised (in dollars per share) | $ 5.63 | |
Outstanding (in shares) | 8,450,074 | |
Outstanding (in dollars per share) | $ 13.04 | |
Outstanding | 7 years 328 days | |
Outstanding | $ 32.4 | |
Vested and exercisable as of June 30, 2016 (in shares) | 4,131,635 | 3,772,736 |
Vested and exercisable as of June 30, 2016 | 6 years 255 days | |
Vested and exercisable as of June 30, 2016 | $ 28.1 |
Note 8 - Net Income Per Share39
Note 8 - Net Income Per Share (Details Textual) - shares | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 5,067,070 | 1,274,490 |
Note 8 - Net Income Per Share -
Note 8 - Net Income Per Share - Computation of Basic and Diluted Net Income (Loss) Per Common Share (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Net income | $ 4,355,000 | $ 7,314,000 | $ 6,789,000 | $ 15,337,000 |
Basic (in shares) | 71,543,809 | 71,517,442 | 71,567,949 | 71,217,137 |
Basic net income per common share (in dollars per share) | $ 0.06 | $ 0.10 | $ 0.09 | $ 0.22 |
Historical net income per share - Diluted | ||||
Net income | $ 4,355,000 | $ 7,314,000 | $ 6,789,000 | $ 15,337,000 |
Weighted average number of common shares outstanding (in shares) | 71,543,809 | 71,517,442 | 71,567,949 | 71,217,137 |
Effect of dilutive stock options (in shares) | 2,509,741 | 3,961,207 | 2,713,889 | 4,037,911 |
Weighted average number of common shares outstanding, diluted (in shares) | 74,053,550 | 75,478,649 | 74,281,838 | 75,255,048 |
Diluted net income per common share (in dollars per share) | $ 0.06 | $ 0.10 | $ 0.09 | $ 0.20 |
Note 9 - Product Lines, Conce41
Note 9 - Product Lines, Concentration of Credit Risk and Significant Customers (Details Textual) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Subsys [Member] | ||||
Number of Product Lines | 1 | |||
Pharmaceutical Wholesalers [Member] | Product Shipments [Member] | Customer One [Member] | ||||
Concentration Risk, Percentage | 18.00% | 33.00% | ||
Pharmaceutical Wholesalers [Member] | Product Shipments [Member] | Customer Two [Member] | ||||
Concentration Risk, Percentage | 17.00% | 20.00% | ||
Pharmaceutical Wholesalers [Member] | Product Shipments [Member] | Customer Three [Member] | ||||
Concentration Risk, Percentage | 16.00% | 18.00% | ||
Pharmaceutical Wholesalers [Member] | Product Shipments [Member] | Customer Four [Member] | ||||
Concentration Risk, Percentage | 13.00% | 15.00% | ||
Pharmaceutical Wholesalers [Member] | Product Shipments [Member] | ||||
Concentration Risk, Number of Customers | 4 | 4 | ||
Pharmaceutical Wholesalers [Member] | Accounts Receivable [Member] | Customer One [Member] | ||||
Concentration Risk, Percentage | 23.00% | 35.00% | ||
Pharmaceutical Wholesalers [Member] | Accounts Receivable [Member] | Customer Two [Member] | ||||
Concentration Risk, Percentage | 18.00% | 20.00% | ||
Pharmaceutical Wholesalers [Member] | Accounts Receivable [Member] | Customer Three [Member] | ||||
Concentration Risk, Percentage | 15.00% | 18.00% | ||
Pharmaceutical Wholesalers [Member] | Accounts Receivable [Member] | Customer Four [Member] | ||||
Concentration Risk, Percentage | 14.00% | 12.00% | ||
Pharmaceutical Wholesalers [Member] | Accounts Receivable [Member] | ||||
Concentration Risk, Number of Customers | 4 | 4 | ||
Specialty Pharmaceutical Retailers [Member] | Product Shipments [Member] | ||||
Concentration Risk, Number of Customers | 1 | |||
Concentration Risk, Percentage | 29.00% | |||
Specialty Pharmaceutical Retailers [Member] | Accounts Receivable [Member] | ||||
Concentration Risk, Number of Customers | 1 | |||
Concentration Risk, Percentage | 20.00% | |||
Concentration Risk, Percentage | 100.00% | 100.00% | 100.00% | 100.00% |
Note 9 - Product Lines, Conce42
Note 9 - Product Lines, Concentration of Credit Risk and Significant Customers - Summary of Net Revenue by Product Line and Percentages (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Subsys [Member] | ||||
Revenues | $ 67,121 | $ 76,700 | $ 129,083 | $ 147,240 |
Dronabinol Sg Capsule [Member] | ||||
Revenues | 933 | 1,163 | ||
Revenues | $ 67,121 | $ 77,633 | $ 129,083 | $ 148,403 |
Note 9 - Product Lines, Conce43
Note 9 - Product Lines, Concentration of Credit Risk and Significant Customers - Percentage of Revenue by Route to Market (Details) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Sales Revenue, Product Line [Member] | Pharmaceutical Wholesalers [Member] | Product Concentration Risk [Member] | ||||
Concentration Risk, Percentage | 69.00% | 99.00% | 71.00% | 99.00% |
Sales Revenue, Product Line [Member] | Specialty Pharmaceutical Retailers [Member] | Product Concentration Risk [Member] | ||||
Concentration Risk, Percentage | 31.00% | 1.00% | 29.00% | 1.00% |
Concentration Risk, Percentage | 100.00% | 100.00% | 100.00% | 100.00% |