Document And Entity Information
Document And Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2015 | Feb. 17, 2016 | Jun. 30, 2015 | |
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 | Yes | ||
Entity Common Stock, Shares Outstanding (in shares) | 71,510,190 | ||
Entity Public Float | $ 832.5 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2015 | ||
Document Fiscal Year Focus | 2,015 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2015 | Dec. 31, 2014 |
Current Assets: | ||
Cash and cash equivalents | $ 79,515,000 | $ 58,106,000 |
Short-term investments | 79,576,000 | 24,757,000 |
Accounts receivable, net of allowances of $7,180 and $5,816 at December 31, 2015 and 2014, respectively | 48,459,000 | 26,544,000 |
Inventories | 41,715,000 | 34,781,000 |
Prepaid expenses and other assets | 3,973,000 | 2,243,000 |
Total current assets | 253,238,000 | 146,431,000 |
Property and equipment, net | 38,382,000 | 29,872,000 |
Long-term investments | 43,219,000 | 23,262,000 |
Deferred income tax assets | 16,331,000 | 12,213,000 |
Other assets | 26,000 | 3,343,000 |
Total assets | 351,196,000 | 215,121,000 |
Current Liabilities: | ||
Accounts payable and accrued expenses | 36,354,000 | 27,454,000 |
Accrued compensation | 10,225,000 | 6,926,000 |
Accrued sales allowances | 32,713,000 | $ 11,296,000 |
Accrued litigation award | 9,567,000 | |
Total current liabilities | 88,859,000 | $ 45,676,000 |
Uncertain income tax position | 8,635,000 | 3,778,000 |
Total liabilities | $ 97,494,000 | $ 49,454,000 |
Stockholders' Equity: | ||
Preferred stock (par value $0.01 per share; 10,000,000 shares authorized; 0 shares issued and outstanding as of December 31, 2015 and 2014, respectively) | ||
Common stock (par value $0.01 per share; 100,000,000 shares authorized; 71,907,858 and 70,702,688 shares issued and outstanding as of December 31, 2015 and 2014, respectively) | $ 719,000 | $ 707,000 |
Additional paid in capital | 245,736,000 | 216,061,000 |
Unrealized gain (loss) on available-for-sale securities | (152,000) | (24,000) |
Notes receivable from stockholders | (21,000) | (21,000) |
Retained earnings (accumulated deficit) | 7,420,000 | (51,056,000) |
Total stockholders' equity | 253,702,000 | 165,667,000 |
Total liabilities and stockholders' equity | $ 351,196,000 | $ 215,121,000 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Accounts receivable, allowance for doubtful accounts | $ 7,180 | $ 5,816 |
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) | 71,907,858 | 70,702,688 |
Common stock, shares outstanding (in shares) | 71,907,858 | 70,702,688 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Income - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Net revenue | $ 330,797,000 | $ 222,125,000 | $ 99,289,000 |
Cost of revenue | 28,854,000 | 22,578,000 | 12,665,000 |
Gross profit | 301,943,000 | 199,547,000 | 86,624,000 |
Operating expenses: | |||
Sales and marketing | 80,668,000 | 58,105,000 | 29,194,000 |
Research and development | 55,281,000 | 33,136,000 | 8,499,000 |
General and administrative | 64,049,000 | $ 44,283,000 | $ 16,372,000 |
Charges related to litigation award | 9,515,000 | ||
Total operating expenses | 209,513,000 | $ 135,524,000 | $ 54,065,000 |
Operating income | $ 92,430,000 | $ 64,023,000 | 32,559,000 |
Other income (expense): | |||
Interest expense | (950,000) | ||
Interest income | $ 502,000 | $ 151,000 | 22,000 |
Other income (expense), net | 36,000 | 2,000 | (54,000) |
Total other income | 538,000 | 153,000 | (982,000) |
Income before income taxes | 92,968,000 | 64,176,000 | 31,577,000 |
Less: income tax expense/(benefit) | 34,492,000 | 26,199,000 | (8,800,000) |
Net income | 58,476,000 | 37,977,000 | $ 40,377,000 |
Unrealized loss on available-for-sale securities | (128,000) | (24,000) | |
Total comprehensive income | $ 58,348,000 | $ 37,953,000 | $ 40,377,000 |
Net income per common share: | |||
Basic (in dollars per share) | $ 0.82 | $ 0.55 | $ 0.78 |
Diluted (in dollars per share) | $ 0.77 | $ 0.52 | $ 0.70 |
Weighted average common shares outstanding | |||
Basic (in shares) | 71,592,581 | 68,759,070 | 51,839,536 |
Diluted (in shares) | 75,707,651 | 73,335,132 | 57,469,234 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity (Deficit) - USD ($) | Convertible Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Net Investment Gain (Loss) Attributable to Parent [Member] | Receivables from Stockholder [Member] | Retained Earnings [Member] | Total |
Balance (in shares) at Dec. 31, 2012 | 14,864,607 | 2,568,116 | |||||
Balance at Dec. 31, 2012 | $ 149,000 | $ 26,000 | $ 64,578,000 | $ (21,000) | $ (129,410,000) | $ (64,678,000) | |
Conversion of preferred to common stock (in shares) | (14,864,607) | 25,586,580 | |||||
Conversion of preferred to common stock | $ (149,000) | $ 256,000 | (107,000) | ||||
Conversion of notes payable to common stock (in shares) | 22,231,024 | ||||||
Conversion of notes payable to common stock | $ 222,000 | 59,062,000 | $ 59,284,000 | ||||
Issuance of common stock - initial public offering (in shares) | 13,800,000 | ||||||
Issuance of common stock - initial public offering | $ 138,000 | 32,318,000 | 32,456,000 | ||||
Issuance of common stock - employee stock purchase plan (in shares) | 376,110 | ||||||
Issuance of common stock - employee stock purchase plan | $ 4,000 | 848,000 | $ 852,000 | ||||
Exercise of stock options (in shares) | 1,807,954 | 1,807,953 | |||||
Exercise of stock options | $ 18,000 | 2,084,000 | $ 2,102,000 | ||||
Excess tax benefits on stock options and awards | 2,745,000 | 2,745,000 | |||||
Stock based compensation - stock options and awards | $ 6,339,000 | 6,339,000 | |||||
Net income (loss) | $ 40,377,000 | 40,377,000 | |||||
Balance (in shares) at Dec. 31, 2013 | 66,369,784 | ||||||
Balance at Dec. 31, 2013 | $ 664,000 | $ 167,867,000 | $ (21,000) | $ (89,033,000) | $ 79,477,000 | ||
Unrealized loss on available-for-sale securities | |||||||
Issuance of common stock - employee stock purchase plan (in shares) | 716,114 | ||||||
Issuance of common stock - employee stock purchase plan | $ 7,000 | 1,982,000 | $ 1,989,000 | ||||
Exercise of stock options (in shares) | 3,616,790 | 3,616,790 | |||||
Exercise of stock options | $ 36,000 | 8,920,000 | $ 8,956,000 | ||||
Excess tax benefits on stock options and awards | 22,003,000 | 22,003,000 | |||||
Stock based compensation - stock options and awards | $ 15,289,000 | 15,289,000 | |||||
Net income (loss) | $ 37,977,000 | 37,977,000 | |||||
Balance (in shares) at Dec. 31, 2014 | 70,702,688 | ||||||
Balance at Dec. 31, 2014 | $ 707,000 | $ 216,061,000 | $ (24,000) | $ (21,000) | $ (51,056,000) | 165,667,000 | |
Unrealized loss on available-for-sale securities | $ (24,000) | (24,000) | |||||
Issuance of common stock - employee stock purchase plan (in shares) | 151,906 | ||||||
Issuance of common stock - employee stock purchase plan | $ 2,000 | $ 2,645,000 | $ 2,647,000 | ||||
Exercise of stock options (in shares) | 1,607,683 | 1,607,683 | |||||
Exercise of stock options | $ 16,000 | 9,508,000 | $ 9,524,000 | ||||
Excess tax benefits on stock options and awards | 13,593,000 | 13,593,000 | |||||
Stock based compensation - stock options and awards | $ 20,382,000 | 20,382,000 | |||||
Net income (loss) | $ 58,476,000 | 58,476,000 | |||||
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 | |
Unrealized loss on available-for-sale securities | $ (128,000) | (128,000) | |||||
Stock based compensation - stock options and awards (in shares) | 5,781 | ||||||
Repurchase of common stock (in shares) | (560,200) | ||||||
Repurchase of common stock | $ (6,000) | $ (16,453,000) | $ (16,459,000) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Cash flows from operating activities: | |||
Net Income (Loss) Attributable to Parent | $ 58,476,000 | $ 37,977,000 | $ 40,377,000 |
Adjustments to reconcile net income to net cash provided by operating activities: | |||
Depreciation and amortization | 5,291,000 | 2,500,000 | 1,788,000 |
Stock-based compensation | 20,382,000 | 15,289,000 | 6,339,000 |
Deferred income tax benefit | (4,118,000) | $ (175,000) | $ (12,038,000) |
Loss on disposal of assets | 41,000 | ||
Excess tax benefits on stock options and awards | $ (13,593,000) | $ (22,003,000) | $ (2,745,000) |
Interest expense accrued on notes payable | 900,000 | ||
Changes in operating assets and liabilities: | |||
Accounts receivable | $ (21,915,000) | $ (10,230,000) | (13,224,000) |
Inventories | (6,934,000) | (20,253,000) | (7,433,000) |
Prepaid expenses and other current assets | 1,586,000 | (3,816,000) | (365,000) |
Accounts payable, accrued expenses and other current liabilities | $ 52,211,000 | $ 50,375,000 | 14,417,000 |
Deferred revenue | $ (3,767,000) | ||
Accrued litigation award | $ 9,423,000 | ||
Net cash provided by operating activities | $ 100,850,000 | $ 49,664,000 | $ 24,249,000 |
Cash flows from investing activities: | |||
Change in restricted cash | 400,000 | $ (400,000) | |
Purchase of investments | $ (74,904,000) | (48,043,000) | |
Purchases of property and equipment | (13,842,000) | (22,245,000) | $ (5,125,000) |
Net cash used in investing activities | (88,746,000) | (69,888,000) | (5,525,000) |
Cash flows from financing activities: | |||
Proceeds from issuance of common stock | 2,647,000 | 1,989,000 | 852,000 |
Excess tax benefits on stock options and awards | 13,593,000 | 22,003,000 | 2,745,000 |
Proceeds from exercise of stock options | 9,524,000 | $ 8,956,000 | $ 2,102,000 |
Repurchase of common stock | $ (16,459,000) | ||
Net repayments on line of credit | $ (11,858,000) | ||
Proceeds from issuance of common stock - initial public offering | 32,456,000 | ||
Net cash provided by financing activities | $ 9,305,000 | $ 32,948,000 | 26,297,000 |
Change in cash and cash equivalents | 21,409,000 | 12,724,000 | 45,021,000 |
Cash and cash equivalents, beginning of period | 58,106,000 | 45,382,000 | 361,000 |
Cash and cash equivalents, end of period | 79,515,000 | 58,106,000 | 45,382,000 |
Supplemental cash flow disclosures: | |||
Cash paid for interest expense | 0 | 0 | 0 |
Cash paid for income taxes | $ 15,351,000 | $ 2,975,000 | $ 991,000 |
Note 1 - Nature of Business
Note 1 - Nature of Business | 12 Months Ended |
Dec. 31, 2015 | |
Notes to Financial Statements | |
Organization, Consolidation and Presentation of Financial Statements Disclosure [Text Block] | 1. Nature of Business 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 specialty pharmaceutical company that develops and commercializes innovative supportive care products. We have one marketed product and one discontinued product: Subsys, a proprietary sublingual fentanyl spray for breakthrough cancer pain in opioid-tolerant patients and Dronabinol SG Capsule, a generic equivalent to Marinol, an approved second-line treatment for chemotherapy-induced nausea and vomiting and anorexia associated with weight loss in patients with AIDS, respectively. In October 2015, we entered into a settlement agreement with Mylan, our former exclusive distributor of Dronabinol SG Capsule and terminated our distribution agreement with Mylan and thus no longer market Dronabinol SG Capsule. |
Note 2 - Significant Accounting
Note 2 - Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2015 | |
Notes to Financial Statements | |
Significant Accounting Policies [Text Block] | 2. Significant Accounting Policies Principles of Consolidation The consolidated financial statements include the accounts of Insys Therapeutics, Inc. and its wholly-owned subsidiary, Insys Pharma, Inc. (“Insys Pharma”). All significant intercompany balances and transactions have been eliminated in the accompanying consolidated financial statements. Reclassification Certain amounts in prior periods have been reclassified to conform to the current period presentation. Fair Value of Financial Instruments The carrying values of our financial instruments, including cash, accounts receivable and accounts payable approximate their fair value due to the short term nature of these financial instruments. Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“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. Revenue Recognition We recognize revenue from the sale of Subsys and Dronabinol SG Capsule. 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 Subsys was commercially launched in March 2012, and is available through a U.S. Food and Drug Administration (“FDA”) mandated Risk Evaluation and Mitigation program known as the Transmucosal Immediate Release Fentanyl program (“TIRF REMS”). We sell Subsys in the United States primarily to wholesale pharmaceutical distributors and to a lesser extent, specialty retail pharmacies, or collectively our customers, on a wholesale basis, 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. Given the limited sales history of prescriptions of Subsys prior to the fourth quarter of 2013, we were not able to reliably estimate expected returns of the product at the time of shipment prior to the fourth quarter of 2013. Accordingly, we initially deferred the recognition of revenue and related product costs of Subsys product shipments until the product was dispensed through patient prescriptions. The quantity of prescription units dispensed was estimated using an analysis of third-party information, including TIRF REMS mandated data and third-party market research data. Beginning in the fourth quarter of 2013, we were able to reasonably estimate product returns of Subsys. Therefore, we began recognizing revenue for Subsys sales at the time of shipment. Accordingly, in the fourth quarter of 2013, we recognized a one-time increase of $1.5 million in net product sales of Subsys, representing product sales previously deferred, net of estimated product returns, wholesaler discounts, prompt pay discounts, stocking allowances, patient discount programs, rebates, and chargebacks. Including deferred cost of sales, this change resulted in a one-time $0.9 million increase to operating income for the year ended December 31, 2013. 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 its 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 adjustments. The allowance for product returns is included in accrued sales allowances. Wholesaler Discounts Prompt Pay Discounts Stocking Allowances Patient Discount Programs Rebates Chargebacks. Dronabinol SG Capsule Dronabinol SG Capsule was commercially launched in December 2011, and we sold Dronabinol SG Capsule exclusively to Mylan Pharmaceuticals, Inc. (“Mylan”) in the United States under a former supply and distribution agreement. Pursuant to the terms of the Mylan agreement, we manufactured Dronabinol SG Capsule under the Mylan label. Mylan distributed Dronabinol SG Capsule and on a monthly basis paid us an amount equal to the value of Dronabinol SG Capsule it sold to wholesale pharmaceutical distributors, less contractually defined deductions for chargebacks, rebates, sales discounts, distribution and storage fees, and royalties. Under the terms of the supply and distribution agreement with Mylan, we were obligated to pay Mylan a royalty of between 10% and 20% on Mylan’s net product sales, and a single digit percentage fee on such sales for distribution and storage services. We bore no risk of product return upon acceptance by Mylan. As Mylan had control over the amount it charged to wholesale pharmaceutical distributors for Dronabinol SG Capsule and the discounts offered to the distributors, the sales price was not fixed and determinable at the date we shipped such products to Mylan. Accordingly, we recognized revenue upon Mylan’s sale of products to wholesale distributors, which was the point at which the sales price was fixed and determinable. We were involved in a dispute with Mylan that commenced in May 2013 and which ultimately led to an arbitration proceeding with the American Arbitration Association (Case No. 55 122 00119 13). In October 2015, we entered into a settlement agreement and full and final mutual and general release with Mylan which settled the claims in dispute and resulted in the termination of this relationship and confirmed the termination of the former supply and distribution agreement. We do not have any current plans to manufacture or market this product in the future. Cash and Cash Equivalents We consider all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents. The carrying value of those investments approximates their fair market value due to their short maturity and liquidity. Cash and cash equivalents include cash on hand and amounts on deposit with financial institutions, which at times may exceed FDIC limits. 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, 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 Accounts Receivable, Net Trade accounts receivable are recorded at the invoice amount net of allowances for wholesaler discounts, prompt pay discounts, stocking allowances, and doubtful accounts. See “Revenue Recognition” above for a description of our wholesaler discounts, prompt pay discounts, stocking allowances and chargebacks. We evaluate the collectability of our accounts receivable based on a variety of factors including the length of time the receivables are past due, the financial health of the customer and historical experience. Inventories Inventories consist of raw materials, work-in-process and finished product and are valued at the lower of cost (first-in, first-out cost method) or market. Inventory costs are capitalized prior to regulatory approval and product launch based on management’s judgment of probable future commercial use and net realizable value of the inventory. Such judgment incorporates our knowledge and best estimate of where the relevant product is in the regulatory process, our required investment in the product, market conditions, competing products and our economic expectations for the product post-approval relative to the risk of manufacturing the product prior to approval. In evaluating the recoverability of inventories produced in preparation for product launches, we consider the probability that revenue will be obtained from the future sale of the related inventory together with the status of the product within the regulatory approval process, as well as the market for the product in its current state. We could be required to permanently write down previously capitalized costs related to pre-approval or pre-launch inventory upon a change in such judgment, due to a denial or delay of approval by regulatory bodies, a delay in commercialization, or other potential factors including product expiration. Property and Equipment Property and equipment are recorded at cost and depreciated using the straight-line method over their estimated useful lives. Maintenance and repairs that do not extend the life of assets are charged to expense when incurred. When property and equipment is disposed of, the related costs and accumulated depreciation are removed from the accounts and any gain or loss is reported in the period the transaction takes place. Property and equipment are reviewed for impairment whenever events or changes in circumstances indicate the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to estimated undiscounted cash flows expected to be generated by the asset. If the carrying amount exceeds its estimated future undiscounted cash flows, an impairment charge is recognized by the amount by which the carrying amount exceeds the fair value of the asset. Income Taxes We account for our deferred income tax assets and liabilities based on differences between the financial reporting and tax bases of assets and liabilities, and net operating loss carry forwards (the “NOLs”) and other tax credit carry forwards. These items are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in the period that includes the enactment date. We record a valuation allowance to reduce the deferred income tax assets to the amount that is more likely than not to be realized. In making such determinations, management considers all available positive and negative evidence, including scheduled reversals of deferred tax liabilities, projected future taxable income, tax planning strategies and recent financial operations. We recognize a tax benefit from uncertain tax positions when it is more likely than not that the position will be sustained upon examination, including resolutions of any related appeals or litigation processes, based on the technical merits of the position. Our policy is to classify interest and penalties associated with income tax liabilities as income tax expense in the statement of operations. Research and Development Expenses Research and development (“R&D”) costs are expensed when incurred. These costs consist of external research and development expenses incurred under agreements with third-party contract research organizations and investigative sites, third-party manufacturing organizations and consultants; employee-related expenses, which include salaries, benefits and stock-based compensation for the personnel involved in our preclinical and clinical drug development activities; and facilities expense, depreciation and other allocated expenses; and equipment and laboratory supplies. Advertising and Marketing Advertising and marketing costs are expensed as incurred. Advertising expense totaled $1,166,000, $800,000 and $645,000 for the three years ending December 31, 2015, 2014 and 2013, respectively. Legal Fees Legal fees are expensed as incurred. Accordingly, we do not accrue for estimated future legal fees to be incurred in connection with litigation and other related legal matters. Legal expense totaled $19,448,000, $16,926,000 and $1,715,000 for the three years ending December 31, 2015, 2014 and 2013, respectively. Stock-Based Compensation Expenses Stock-based compensation cost is estimated at the grant date based on the fair value of the award, and the cost is recognized as expense ratably over the vesting period. We use the Black-Scholes option pricing model for estimating the grant date fair value of stock options using the following assumptions: ● Exercise price - Prior to May 7, 2013, we determined the exercise price based on valuations using the best information available to management at the time of the valuations. Subsequent to our initial public offering of common stock (“IPO”) on May 7, 2013, the exercise price is equal to the fair market value of the stock on the grant date which is determined based on quoted market prices. ● Volatility - Prior to our IPO, we did not have a reliable history of market prices for our common stock. Following our IPO, while we have an active trading market, we do not have sufficient historical data to accurately estimate volatility for the period equivalent to the expected term of the stock option grants. Accordingly, we estimate the expected stock price volatility for our common stock by taking the median historical stock price volatility for industry peers based on daily price observations over a period equivalent to the expected term of the stock option grants. ● Expected term - The expected term is based on a simplified method which defines the term as the average of the contractual term of the options and the weighted-average vesting period for all open employee awards. ● Risk-free rate - The risk-free interest rate for the expected term of the option is based on the average market rate on U.S. treasury securities in effect during the quarter in which the options were granted. ● Dividends - The dividend yield assumption is based on our history and expectation of paying no dividends. ● Forfeitures - Forfeitures have historically been insignificant. Use of Estimates The preparation of financial statements in conformity with U.S. generally accepted accounting principles (“GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expense during the reporting period. Actual results could materially differ from those estimates. Segment Information FASB ASC No. 280, “Segment Reporting” establishes standards for reporting information about reportable segments. Operating segments are defined as components of an enterprise about which separate financial information is available that is evaluated regularly by the chief operating decision maker, or decision-making group (“CODM”), in deciding how to allocate resources and in assessing performance. The CODM evaluates revenues and gross profits based on product lines and routes to market. Based on our integration and management strategies, we operate in a single reportable segment. Recent Accounting Pronouncements In May 2014, the FASB issued Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers In August 2014, the FASB issued ASU No. 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern In July 2015, the FASB issued ASU No. 2015-11, Inventory (Topic 330): Simplifying the Measurement of Inventory In November 2015, the FASB issued ASU 2015-17, Income Taxes (Topic 470): Balance Sheet Classification of Deferred Taxes 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 |
Note 3 - Short-term and Long-te
Note 3 - Short-term and Long-term Investments | 12 Months Ended |
Dec. 31, 2015 | |
Notes to Financial Statements | |
Investment [Text Block] | 3. Short-Term and Long-Term Investments Investments consisted of the following at December 31, 2015 (in thousands): December 31, 2015 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 Investments consisted of the following at December 31, 2014 (in thousands): December 31, 2014 Cost Unrealized Gains Unrealized Losses Other- Than- Temporary Impairment Losses Fair Value Cash and Cash Equivalents Short-term Investments Long-term Investments Cash $ 44,785 $ - $ - $ - $ 44,785 $ 44,785 $ - $ - Money market securities 13,321 - - - 13,321 13,321 - - Certificates of deposit 12,657 - - - 12,657 - 3,160 9,497 Marketable securities: - Corporate securities 10,837 - (26 ) - 10,811 - 6,229 4,582 Federal agency securities 9,512 - (10 ) - 9,502 - 5,009 4,493 Municipal securities 15,037 15 (3 ) - 15,049 - 10,359 4,690 Total marketable securities 35,386 15 (39 ) - 35,362 - 21,597 13,765 $ 106,149 $ 15 $ (39 ) $ - $ 106,125 $ 58,106 $ 24,757 $ 23,262 The amortized cost and estimated fair value of the marketable securities, by maturity, are shown below (in thousands): December 31, 2015 December 31, 2014 Amortized Cost Fair Value Amortized Cost Fair Value Marketable securities: Due in one year or less $ 66,148 $ 66,094 $ 21,597 $ 21,597 Due after one year through 5 years 33,731 33,633 13,789 13,765 Due after 5 years through 10 years - - - - Due after 10 years - - - - $ 99,879 $ 99,727 $ 35,386 $ 35,362 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): December 31, 2015 December 31, 2014 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 $ 25,137 $ (68 ) $ - $ - $ 9,809 $ (26 ) $ - $ - Federal agency securities 18,759 (65 ) - - 6,490 (10 ) - - Municipal securities 22,981 (35 ) - - 1,832 (3 ) - - $ 66,877 $ (168 ) $ - $ - $ 18,131 $ (39 ) $ - $ - As of December 31, 2015 and 2014, we have concluded that 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 | 12 Months Ended |
Dec. 31, 2015 | |
Notes to Financial Statements | |
Fair Value Disclosures [Text Block] | 4. Fair Value Measurement At December 31, 2015 and 2014, we held short-term and long-term investments, as described 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 December 31, 2015 and 2014 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 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 investments measured at fair value on a recurring basis subject to the disclosure requirements of ASC 820 at December 31, 2015 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: 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 $ - Our investments measured at fair value on a recurring basis subject to the disclosure requirements of ASC 820 at December 31, 2014 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: Corporate securities $ 10,811 $ - $ 10,811 $ - Federal agency securities 9,502 - 9,502 - Municipal securities 15,049 - 15,049 - Total assets measured at fair value $ 35,362 $ - $ 35,362 $ - |
Note 5 - Inventories
Note 5 - Inventories | 12 Months Ended |
Dec. 31, 2015 | |
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): December 31, 2015 December 31, 2014 Finished goods $ 28,216 $ 30,998 Work-in-process 7,018 4,316 Raw materials and supplies 6,481 2,785 Total inventories 41,715 38,099 Less: non-current work-in-process - (3,318 ) $ 41,715 $ 34,781 As of December 31, 2015 and 2014, raw materials inventories consisted of raw materials used in the manufacture of the active pharmaceutical ingredient (“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 work-in-process represent those inventories pending FDA approval which is not expected within 12 months of the balance sheet date and are included in other assets in our consolidated balance sheets. As of December 31, 2015, 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. |
Note 6 - Property and Equipment
Note 6 - Property and Equipment | 12 Months Ended |
Dec. 31, 2015 | |
Notes to Financial Statements | |
Property, Plant and Equipment Disclosure [Text Block] | 6. Property and Equipment Property and equipment are comprised of the following (in thousands): Estimated Useful Life As of December 31, (in years) 2015 2014 Computer equipment 3 - 7 $ 2,798 $ 1,530 Scientific equipment 3 - 10 9,283 5,928 Furniture 3 - 10 2,022 1,545 Manufacturing equipment 7 - 10 19,536 13,101 Leasehold improvements * 16,771 16,688 Less: accumulated depreciation and amortization (12,028 ) (8,920 ) Total fixed assets $ 38,382 $ 29,872 * The estimated useful life of the leasehold improvements is the lesser of the lease term or the estimated useful life. Total depreciation and amortization expense for the years ended December 31, 2015, 2014 and 2013 was $5,295,000, $2,500,000 and $1,788,000, respectively. |
Note 7 - Commitments and Contin
Note 7 - Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2015 | |
Notes to Financial Statements | |
Commitments and Contingencies Disclosure [Text Block] | 7. Commitments and Contingencies Lease Commitments We lease facilities under non-cancelable operating lease agreements. Future minimum commitments for these operating leases in place as of December 31, 2015, with a remaining non-cancelable lease term in excess of one year, are as follows (in thousands): Years ending December 31, 2016 $ 2,669 2017 2,612 2018 2,721 2019 2,799 2020 2,875 Thereafter 3,841 Total $ 17,517 The terms of certain lease agreements provide for rental payments on a graduated basis. We recognize rent expense on the straight-line basis over the lease period and have accrued for rent expense incurred but not paid. Rent expense under operating leases for the years ended December 31, 2015, 2014 and 2013 was approximately $2,445,000, $1,698,000, and $498,000, respectively. 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. On October 30, 2015, we entered into an amended and restated supply, development & exclusive licensing agreement with Aptargroup, Inc. 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. The following table sets forth our aggregate minimum purchase commitments with DPT and Aptar under these agreements (in thousands): Years ending December 31, 2016 $ 2,000 2017 10,450 2018 14,650 2019 18,260 2020 20,840 Thereafter 4,330 Total $ 70,530 Defined Contribution Retirement Plans (401(k) Plan) We sponsor a 401(k) plan covering all full-time employees. Participants may contribute up to the legal limit. The 401(k) plan provides for employee contributions, and beginning October 2014, our matching contribution is 50 percent of the first 6 percent of earnings contributed by each participant. Contractual Commitments Manufacture and Supply Agreements We maintain certain manufacture and supply agreements with third party vendors for the manufacturing, processing, and packaging of Subsys which expire in 2016. As of December 31, 2015, our remaining estimated annual contractual obligations under these agreements are not material. Legal Matters Other than the matters that we have disclosed below, we from time to time become involved in various ordinary course legal disputes and claims and administrative and regulatory proceedings, which include intellectual property and commercial litigation, governmental and regulatory investigations, employee related issues and disputes and other business matters, which we do not 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 and could ultimately have a material adverse effect on our consolidated financial position and could cause the market value of our common shares to decline . While we believe we have valid defenses in these matters, litigation and governmental and regulatory investigations are inherently uncertain and we may in the future incur material judgments or enter into material settlements of claims. Except as it pertains to the $9,567,000 accrued for the dispute with Dr. Kottayil and the settlement payment related to the 2014 federal securities litigation that was covered by our director and officers insurance policies as noted below, we believe that the probability of unfavorable outcome or loss related to all of the other litigation matters discussed below 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 of 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. 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 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 could result from any government investigation or proceeding, as well as a corporate integrity agreement or similar government mandated compliance document. 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. Health Insurance Portability and Accountability Act 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. In connection with the review of this matter by the Compliance Committee of our Board of Directors, with the assistance of outside legal counsel reporting directly to the Compliance Committee, we have taken a number of remedial actions and implemented enhancements to our compliance controls regarding relationships with health care providers. We will continue to assess these matters to ensure we have an effective compliance program. 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 drug 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 agreed to make 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 early 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 unanticipated legal costs in connection with defending any claims raised. Any potential resulting fines, restitution, damages and penalties, settlement payments 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 Between May 15 and May 19, 2014, two complaints (captioned Larson v. Insys Therapeutics, Inc., Case No. 14-cv-01043-GMS) and (Li vs. Insys Therapeutics, Inc., Case No 14-cv-01077-DGC) were filed in the U.S. District Court for the District of Arizona, or Arizona District Court, against us and certain of our current officers. The complaints were brought as purported class actions, on behalf of purchasers of our common stock. 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. On July 14, 2014, several purported shareholders filed motions to consolidate the two cases, appoint a lead plaintiff, and appoint lead counsel. On August 29, 2014, the Arizona District Court issued an order consolidating the action, appointing Hongwei Li as lead plaintiff, and appointing the lead counsel. Lead plaintiffs complaint was filed on October 27, 2014. On December 11, 2014, we moved to dismiss the amended consolidated complaint. On March 19, 2015, the parties participated in a mediation and the parties subsequently agreed in principle, on April 14, 2015, to settle the action. On April 20, 2015, the parties filed a Notice of Settlement with the Court. On April 29, 2015, the Court ordered that the lawsuit be dismissed within 60 days, vacated all pending hearings, and denied all pending motions as moot. On May 28, 2015, the parties filed a Stipulation of Settlement, which provided the terms of a settlement agreement. On June 2, 2015, the Court granted preliminary approval of the settlement agreement and the potential class members have been (or will be) notified of the proposed settlement and the procedure by which they can object to the settlement or request to be excluded from the class. On December 7, 2015, the Court issued a final judgment and dismissal order granting final approval of the settlement agreement and dismissing the case with prejudice. Because we met our retainage amount under the applicable policy, we believe that any potential obligations that relate to the settlement in this matter are fully covered under our directors and officers insurance policy. Accordingly, we did not accrue for any contingencies in this matter into our operating results. 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, seek compensatory and punitive damages. Discovery on all of the foregoing claims was completed and a trial was scheduled to commence on January 27, 2014; however, on January 22, 2014, the court vacated the trial and granted plaintiffs leave to file an amended complaint to add Insys Therapeutics, Inc. as a defendant. On January 29, 2014, the plaintiffs filed a second amended complaint in the Arizona Superior Court in which Insys Therapeutics, Inc., the parent of Insys Pharma, 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 allegedthat they were entitled to rescissory damages, plaintiffs also added our majority stockholder, a private trust, as a defendant to the breach of fiduciary duty claim and plaintiffs revised their fraud claim against the Insys Pharma director defendants. On February 25, 2014, we filed a Motion to Dismiss the Kottayil Plantiffs’ claims for a statutory and common law appraisal. The motion was denied on May 2, 2014. 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 us 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. The court still had to resolve certain post-trial issues before a final judgment was entered. On June 29, 2015, we moved the court to award Insys Therapeutics, Inc. its attorneys’ fees in connection with its successful defense of plaintiff’s claims of successor liability and fraudulent transfer. The court denied Insys Therapeutics request for attorney’s fees. 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 plaintiffs’ request to submit an application for attorneys’ fees for his defense of the Insys Pharma counterclaims, finding that the request was premature. 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. Plaintiffs opening brief is due to the Court of Appeals on March 7, 2016. As a result of the final ruling, we have accrued $9,567,000 at September 30, 2015 including $2,249,000 of estimated pre-and post-judgement interest. The pending appeal (and cross appeal) could cause the estimates to vary materially from the final award. On or around November 1, 2015 we received a notice from Dr. Kottayil’s attorneys demanding indemnification for legal and other defense costs alleged to have been incurred in connection with Dr. Kottayil’s defense of the Insys Pharma counterclaims in the amount of $3,630,000. We are 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. Insys Therapeutics, Inc. vs. Mylan Pharmaceuticals . Patent-Related Matters. Wayne Automatic Fire Sprinklers |
Note 8 - Equity
Note 8 - Equity | 12 Months Ended |
Dec. 31, 2015 | |
Notes to Financial Statements | |
Stockholders' Equity Note Disclosure [Text Block] | 8. Equity Preferred Stock In August 2014, we entered into a Rights Agreement with respect to a newly-designated Series A Participating Preferred Stock. In connection with the Rights Agreement, our Board of Directors declared a dividend distribution of the right to purchase one one-hundredth of one share of our newly designated Series A Junior Participating Preferred Stock, par value $0.001 per share (a “Right”) for each outstanding share of common stock, par value $0.01 per share, held by the stockholders of the Company at the close of business on September 1, 2014 (the “Record Date”). Each Right entitles the registered holder to purchase from us one one-hundredth of a share of preferred stock (each, a “Preferred Share” and collectively, the “Preferred Shares”) at a price of $160 per one one-hundredth of a Preferred Share (the “Purchase Price”), subject to adjustment. Each one one-hundredth of a Preferred Share has the designations, powers, privileges, preferences, rights, qualifications, limitations and restrictions that are designed to make it the economic equivalent of one share of common stock. The Rights will not become exercisable until the earlier to occur of the close of business on (i) the tenth calendar day following acquisition by any person, entity or group of affiliated or associated persons of beneficial ownership of 15% or more of our outstanding shares of common stock (an “Acquiring Person”) or (ii) the tenth business day (or such later date as may be determined by action of the Board prior to such time as any person or entity becomes an Acquiring Person) following the date of commencement of, or the first announcement of, an intention to commence, a tender offer or exchange offer, the consummation of which would result in any person or entity or group of persons or entities acting in concert becoming an Acquiring Person (the earlier of such dates being called the “Distribution Date”). Until the Distribution Date, the Rights will be transferable with and only with our Common Shares. The Rights will expire ten years after the execution of the Rights Agreement unless the Rights are earlier redeemed or exchanged by us. Each Preferred Share is entitled to a minimum preferential quarterly dividend payment equal to the greater of $1.00 per share or 100 times the aggregate per share price of all cash and non-cash dividends declared per share of common stock. In the event of liquidation, the holders of the Preferred Shares would be entitled to a minimum preferential liquidation payment of $100 per share plus an amount equal to accrued and unpaid dividends and distributions thereon, provided that the Preferred Shares would be entitled to receive an aggregate amount per share equal to 100 times the aggregate amount to be distributed per share to holders of common stock. Each Preferred Share has 100 votes, voting together with the common stock. Common Stock On February 26, 2014, our Board of Directors approved a three-for-two stock split of our common stock to be effected through a stock dividend. The record date for the stock split was the close of business on March 17, 2014, with share distribution occurring on March 28, 2014. As a result of the dividend, shareholders received one additional share of Insys Therapeutics, Inc. common stock, par value $0.0002145, for each two shares they held as of the record date. All share and per share amounts have been retroactively restated for the effects of this stock split. On May 6, 2014, our shareholders approved an amendment to our certificate of incorporation to increase the authorized shares of common stock from 50,000,000 to 100,000,000 and an amendment to increase the par value for our common stock to $0.01 per share. Our consolidated financial statements and notes herein have been retroactively restated to reflect the impact of this amendment. On May 5, 2015, our Board of Directors approved a two-for-one stock split of our common stock to be effected through a stock dividend. The record date for the stock split was the close of business on May 26, 2015, with share distribution occurring on June 8, 2015. As a result of the dividend, shareholders received one additional share of Insys Therapeutics, Inc. common stock, par value $0.01, for each one share they held as of the record date. All share and per share amounts have been retroactively restated for the effects of this stock split. Initial Public Offering On May 7, 2013, we completed our IPO, pursuant to which we sold 13,800,000 shares of our common stock (4,600,000 on a pre-split basis) at a price of $2.67 per share ($8.00 on a pre-split basis), which included the underwriters’ exercise of their over-allotment option. As a result of the IPO, we raised a total of $32.5 million in net proceeds after deducting underwriting discounts and commissions of $2.6 million and offering expenses of $1.8 million. These costs have been recorded as a reduction of the proceeds received in arriving at the amount recorded in additional paid-in capital. Upon completion of the IPO, all outstanding shares of our preferred stock were converted into 25,586,590 shares of common stock (8,528,860 on a pre-split basis). Also, upon completion of our IPO, the outstanding balance of principal and accrued interest related to several promissory and demand notes in favor of entities controlled by Dr. John Kapoor in the amount of $59,284,000 were converted into 22,231,024 shares of common stock (7,410,341 at a pre-split basis). Stock Repurchase Program On November 3, 2015, we adopted a new stock repurchase program. The stock repurchase program authorizes up to $50 million in repurchases of common stock in the open market, block transactions on or off an exchange, or in privately negotiated transactions at management's discretion from time to time. The stock repurchase program is effective immediately, and there is no fixed termination date for this program. The repurchase program has no time limit and may be suspended for periods or discontinued at any time. During the year ended December 31, 2015, we acquired 560,200 shares of common stock at an aggregate price of $16,459,000. We intend to retire all acquired shares. |
Note 9 - Stock-based Compensati
Note 9 - Stock-based Compensation | 12 Months Ended |
Dec. 31, 2015 | |
Notes to Financial Statements | |
Disclosure of Compensation Related Costs, Share-based Payments [Text Block] | 9. Stock-based Compensation We currently have the following stock-based incentive plans: 2013 Employee Stock Purchase Plan The 2013 Employee Stock Purchase Plan (the “ESPP”) was adopted by our Board of Directors and approved by our stockholders, and became effective in connection with our initial public offering in May 2013. Under the terms of the ESPP, eligible employees are granted a purchase right to purchase shares of our common stock that cannot exceed 15% of their earnings, nor exceed the Board of Director defined limits on the number of our common shares that can be offered under the ESPP. The purchase right entitles the eligible employee to purchase shares at the lesser of an amount equal to 85% of the fair market value of the shares on the offering date or 85% of the fair market value of the shares on the purchase date. The ESPP authorizes the issuance of 530,400 shares of common stock (175,000 on a pre-split basis) pursuant to purchase rights granted to our employees or to employees of any of our designated affiliates. The number of shares of common stock reserved for issuance will automatically increase on January 1 of each calendar year, from January 1, 2014 through January 1, 2023, by the least of (a) 1% of the total number of shares of common stock outstanding on December 31 of the preceding calendar year, (b) 600,000 shares (200,000 on a pre-split basis), or (c) a number determined by our Board of Directors that is less than (a) and (b). The ESPP is intended to qualify as an “employee stock purchase plan” within the meaning of Section 423 of the Internal Revenue Code of 1986, as amended (the “Code”). As of December 31, 2015, 1,244,130 shares of common stock have been purchased under the ESPP. 2013 Equity Incentive Plan The 2013 Equity Incentive Plan (the “2013 Plan”) is the successor to and continuation of the 2006 Equity Incentive Plan and the Insys Pharma, Inc., Amended and Restated Equity Incentive Plan. The 2013 Plan was adopted by our Board of Directors and approved by our stockholders, and became effective in connection with our initial public offering in May 2013. The 2013 Plan provides for the grant of stock awards, including stock options, restricted stock, stock appreciation rights, performance units, performance shares and other stock awards, to our employees, directors and consultants. The number of shares of common stock reserved for issuance will automatically increase on January 1 of each calendar year, from January 1, 2014 through January 1, 2023, by the lesser of (a) 4% of the total number of shares of common stock outstanding on December 31 of the preceding calendar year; or (b) a number of shares of common stock that may be determined each year by the Registrants Board of Directors that is less than the preceding clause (a). As of December 31, 2015, options to purchase 7,138,089 shares of common stock were outstanding and 2,183,946 shares remained available for future grant. Amounts recognized in the consolidated statements of comprehensive income with respect to our stock-based compensation plans were as follows (in thousands): Years Ended December 31, 2015 2014 2013 Research and development $ 633 $ 5,498 $ 915 General and administrative 19,749 9,791 5,424 Total cost of stock-based compensation $ 20,382 $ 15,289 $ 6,339 Included in stock-based compensation for the years ended December 31, 2015 and 2014 was approximately $4,867,000 and $4,016,000, respectively, of expense associated with the accelerated vesting of option awards related to two terminated employees. There was no such accelerated vesting of option awards during 2013. The following table summarizes stock option activity during the year ended December 31, 2015: Weighted Weighted Average Aggregate Average Remaining Intrinsic Number of Exercise Contractual Value Shares Price Term (in years) (in millions) Outstanding as of December 31, 2012 6,517,719 $ 1.06 Granted 4,460,100 $ 4.86 Cancelled (174,888 ) $ 2.86 Exercised (1,807,953 ) $ 1.15 Outstanding as of December 31, 2013 8,994,978 $ 2.90 Granted 3,397,198 $ 14.57 Cancelled (1,068,224 ) $ 7.71 Exercised (3,616,790 ) $ 2.48 Outstanding as of December 31, 2014 7,707,162 $ 7.57 Granted 1,733,671 $ 29.38 Cancelled (695,061 ) $ 17.03 Exercised (1,607,683 ) $ 5.89 $ 40.2 Outstanding as of December 31, 2015 7,138,089 $ 12.33 7.8 $ 118.7 Vested and exercisable as of December 31, 2015 3,722,736 $ 6.91 7.0 $ 81.1 The aggregate intrinsic value for stock options outstanding and exercisable is defined as the positive difference between the fair market value of our common stock and the exercise price of the stock options. As of December 31, 2015, we expect to recognize $41,370,000 of stock-based compensation for our outstanding options over a weighted-average period of 2.9 years. The total fair value of shares vested for the years ended December 31, 2015, 2014, and 2013 was $25,392,000, $14,572,000 and $5,785,000, respectively. Cash received from option exercises under all share-based payment arrangements for the years ended December 31, 2015, 2014 and 2013 was $9,524,000, $8,956,000 and $2,102,000, respectively. For the years ended December 31, 2015, 2014 and 2013, we recorded net reductions of $13,593,000, $22,003,000 and $2,745,000 respectively, of our federal and state income tax liability, with an offsetting credit to additional paid-in capital resulting from the excess tax benefits related to exercised stock options. Stock Option Valuation Information The weighted-average assumptions used to estimate the fair value of employee stock options granted during the periods presented are as follows: 2015 2014 2013 Expected volatility 69.9% 69.3% 73.5% Risk-free interest rate 1.9% 1.7% 2.0% Expected term (in years) 7.0 6.0 7.0 Expected dividend yield 0.0% 0.0% 0.0% For the years ended December 31, 2015, 2014, and 2013 the weighted-average estimated fair value per option granted was $19.20, $10.53 and $5.04, respectively. |
Note 10 - Income Taxes
Note 10 - Income Taxes | 12 Months Ended |
Dec. 31, 2015 | |
Notes to Financial Statements | |
Income Tax Disclosure [Text Block] | 10. Income Taxes Income tax (benefit) expense consists of the following (in thousands): Years Ended December 31, 2015 2014 2013 Current income taxes: Federal $ 32,039 $ 22,500 $ 2,281 State and local 6,572 3,874 957 Total current income tax 38,611 26,374 3,238 Deferred income taxes: Federal (2,997 ) 867 (9,123 ) State and local (1,122 ) (1,042 ) (2,915 ) Total deferred income tax (4,119 ) (175 ) (12,038 ) Income tax expense/(benefit) $ 34,492 $ 26,199 $ (8,800 ) As of December 31, 2015, we had approximately $1.2 million of federal net operating loss carryforwards (“NOLs”) all of which are subject to a significant Section 382 limitation. Under Section 382 of the Code, substantial changes in our ownership may limit the amount of NOLs that can be utilized annually in the future to offset taxable income, if any. Specifically, this limitation may arise in the event of a cumulative change in ownership of our company of more than 50% within a three-year period as determined under the Code, which we refer to as an ownership change. Any such annual limitation may significantly reduce the utilization of these NOLs before they expire. Our ability to utilize federal NOLs created prior to the NeoPharm merger is significantly limited. For federal tax purposes, the Section 382 NOL carryforward is limited on an annual basis and begins expiring in 2018. For state tax purposes, we had approximately $268.3 million of state NOLs at December 31, 2015, all of which relate to Illinois. This $268.3 million of state NOLs excludes $1.7M of NOLs under ASC Topic 718 that have not been benefitted. Based on projections, we estimate that approximately $259.4 million of these Illinois NOLs will not be utilized. For this reason, we recorded a valuation allowance for the estimated tax benefit relating to this amount, or $20.2 million. The Illinois NOLs began expiring in 2015 if not utilized. At December 31, 2012, a full valuation allowance was placed on our net deferred tax assets because we determined that it was more likely than not that we would not benefit from these tax attributes in the future. During the fourth quarter of 2013, we determined it was more likely than not that we would be able to utilize nearly all types of our deferred tax assets, including all federal net operating loss carryforwards. This determination was made based on our profitability in 2013 and our expectations of future profitability. Accordingly, we reversed the deferred tax asset valuation allowance associated with the majority of our deferred tax assets. Deferred Income Taxes The tax effects of temporary differences and carry forwards that give rise to the deferred tax assets and liabilities are comprised of the following as of December 31 (in thousands): Deferred income tax assets: 2015 2014 NOLs and credits $ 26,931 $ 24,683 Start-up expenditures 2,896 3,349 Stock-based compensation 8,578 4,351 Allowances 1,581 2,516 Expenses currently not deductible for tax purposes 5,640 3,884 Other 284 149 Gross deferred tax assets 45,910 38,932 Deferred income tax asset valuation allowance (20,191 ) (20,402 ) Deferred income tax assets 25,719 18,530 Deferred income tax liabilities: Federal impact of state taxes (1,778 ) (1,384 ) Property and equipment (6,189 ) (4,354 ) Prepaid expenses (1,421 ) (579 ) Net deferred income tax assets $ 16,331 $ 12,213 In assessing the realization of deferred tax assets, we consider whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. We also consider the scheduled reversal of deferred tax liabilities, projected future taxable income or losses, and tax planning strategies in making this assessment. Based upon our current net income and projections for future taxable income over the periods in which the deferred tax assets are deductible, we believe that, with the exception of the Illinois NOL discussed above, the realization of these tax assets is more likely than not. As such, with the exception of the valuation allowance that has been placed on the future tax benefit relating to our Illinois NOLs, no other valuation allowance exists on our deferred tax assets at December 31, 2015. Effective Tax Rate Reconciliation: Our federal statutory tax rate is 35.0%, while our effective tax rate was 37.1% for the year ended December 31, 2015 as set forth below: 2015 2014 2013 U.S. statutory tax rate 35.0 % 35.0 % 35.0 % Increase (reduction) of income taxes resulting from: State income taxes, net of federal benefit 1.7 % 2.9 % 11.8 % Non-deductible litigation expense 4.3 % 3.0 % - Non-deductible and includible items and credits 0.8 % 0.6 % 2.3 % Research and other credits (4.6 )% (2.2 )% (1.8 )% Uncertain tax positions 2.7 % 1.8 % - Domestic manufacturing deduction (3.0 )% (0.3 )% - Other 0.4 % - (0.6 )% Change in valuation allowance (0.2 )% - (74.6 )% Total (benefit) provision for income taxes 37.1 % 40.8 % (27.9 )% The following is a reconciliation of the beginning and ending amounts of unrecognized tax benefits (in thousands): Years Ended December 31, 2015 2014 Beginning balance $ 5,366 $ 325 Additions based on current year's tax positions 3,885 450 Additions based on prior year's tax positions (240 ) 4,591 Ending balance $ 9,011 $ 5,366 We establish reserves when it is more likely than not that we will not realize the full tax benefit of a position. We had a reserve of $9,011,000 as of December 31, 2015, mostly related to tax credits of $1,971,000, state and local income tax filing positions of $5,360,000, and $1,680,000 of other permanent differences. Altho u gh it is reasonably po ssi ble that certain unrecognized tax benefits may increase or decrease within the next twelve months due to tax examination changes, settlement activities, expirations of statutes of limitations, or the impact on recognition and measurement considerations related to the results of published tax cases or other s imilar activities, we do not anticipate any significant changes to unrecognized tax benefits over the next 12 months . Approximately $406,000 of interest has been included in income taxes and accounted for on the ba l an c e sheet related to unrecognized tax pos i tions as of December 31 , 2015. Tax years subsequent to 2011 remain open to examination by federal and state taxing authorities. In addition, our reverse acquisition NOLs remain open to examination. |
Note 11 - Net Income Per Share
Note 11 - Net Income Per Share | 12 Months Ended |
Dec. 31, 2015 | |
Notes to Financial Statements | |
Earnings Per Share [Text Block] | 11. Net Income per Share Basic net income per common share is computed by dividing the net income 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 (in thousands, except per share amounts): Years Ended December 31, 2015 2014 2013 Historical net income per share - Basic Numerator: Net income $ 58,476 $ 37,977 $ 40,377 Denominator: Weighted average number of common shares outstanding 71,592,581 68,759,070 51,839,536 Basic net income per common share $ 0.82 $ 0.55 $ 0.78 Historical net income per share - Diluted Numerator: Net income $ 58,476 $ 37,977 $ 40,377 Denominator: Weighted average number of common shares outstanding 71,592,581 68,759,070 51,839,536 Effect of dilutive stock options 4,115,070 4,576,062 5,629,698 Weighted average number of common shares outstanding 75,707,651 73,335,132 57,469,234 Diluted net income per common share $ 0.77 $ 0.52 $ 0.70 The calculation of diluted net income per common share excludes the effects of 1,460,986 and 1,780,372 outstanding stock options for the year ended December 31, 2015 and 2014, respectively, as the impact of these options was anti-dilutive. There were no anti-dilutive share equivalents for the year ended December 31, 2013. |
Note 12 - Product Lines, Concen
Note 12 - Product Lines, Concentration of Credit Risk and Significant Customers | 12 Months Ended |
Dec. 31, 2015 | |
Notes to Financial Statements | |
Concentration Risk Disclosure [Text Block] | 12. Product Lines, Concentration of Credit Risk and Significant Customers We are engaged in the business of developing and selling pharmaceutical products. We have one marketed and one discontinued product line, consisting of Subsys and Dronabinol SG Capsule, respectively. 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 Years Ended December 31, 2015 2014 2013 Subsys $ 329,514 $ 219,530 $ 95,740 Dronabinol SG Capsule 1,283 2,595 3,549 Total net revenue $ 330,797 $ 222,125 $ 99,289 Percent of Revenue by Route to Market Years Ended December 31, 2015 2014 2013 Pharmaceutical wholesalers 95 % 99 % 96 % Specialty pharmaceutical retailers 5 % 0 % 0 % Generic pharmaceutical distributors 0 % 1 % 4 % 100 % 100 % 100 % All our products are sold in the United States of America. Product shipments to four pharmaceutical wholesalers accounted for 32%, 20%, 17% and 14% of shipments of Subsys for the year ended December 31, 2015. Product shipments to four pharmaceutical wholesalers accounted for 38%, 22%, 14% and 14% of shipments of Subsys for the year ended December 31, 2014. Product shipments to four pharmaceutical wholesalers accounted for 30%, 21%, 20% and 19% of shipments of Subsys for the year ended December 31, 2013. Four pharmaceutical wholesalers’ accounts receivable balances accounted for 20%, 19%, 17% and 14% of accounts receivable as of December 31, 2015. Four pharmaceutical wholesalers’ accounts receivable balances accounted for 26%, 24%, 23% and 14% of gross accounts receivable as of December 31, 2014. Currently, for Subsys, we use one vendor as our sole supplier of the active pharmaceutical ingredient in this product. Financial instruments that potentially subject us to concentrations of credit risk consist principally of cash and trade accounts receivable. We place our cash with high credit quality financial institutions and generally limit the amount of credit exposure to the amount of FDIC coverage. However, periodically during the year, we maintain cash in financial institutions in excess of the current FDIC insurance coverage limit of $250,000. We perform ongoing credit evaluations of our customers’ financial condition but do not typically require collateral to support customer receivables. We established an allowance for doubtful accounts based upon factors surrounding the credit risk of specific customers, historical trends and other information. |
Note 13 - Supplemental Financia
Note 13 - Supplemental Financial Information | 12 Months Ended |
Dec. 31, 2015 | |
Notes to Financial Statements | |
Schedule of Valuation and Qualifying Accounts Disclosure [Text Block] | 13. Supplemental Financial Information A summary of additions and deductions related to the allowances for accounts receivable for the years ended December 31, 2015 and 2014 are as follows (in thousands): Balance at Beginning of Year Charged to Costs and Expenses Utilization Balance at End of Year Allowance for doubtful accounts: Year ended December 31, 2015 $ 398 $ 413 $ - $ 811 Year ended December 31, 2014 $ - $ 398 $ - $ 398 Year ended December 31, 2013 $ - $ - $ - $ - Allowance for sales wholesaler discounts, prompt pay discounts, stocking allowances, and chargebacks: Year ended December 31, 2015 $ 5,418 $ 36,849 $ (35,898 ) $ 6,369 Year ended December 31, 2014 $ 2,748 $ 22,395 $ (19,725 ) $ 5,418 Year ended December 31, 2013 $ 834 $ 8,512 $ (6,598 ) $ 2,748 |
Note 14 - Quarterly Results of
Note 14 - Quarterly Results of Operations (Unaudited) | 12 Months Ended |
Dec. 31, 2015 | |
Notes to Financial Statements | |
Quarterly Financial Information [Text Block] | 14. Quarterly Results of Operations (Unaudited) The following table sets forth a summary of our unaudited quarterly operating results for each of the last eight quarters in the period ended December 31, 2015. We have derived this data from our unaudited consolidated interim financial statements that, in our opinion, have been prepared on substantially the same basis as the audited financial statements contained elsewhere in this report and include all normal recurring adjustments necessary for a fair presentation of the financial information for the periods presented. These unaudited quarterly results should be read in conjunction with our financial statements and notes thereto included elsewhere in this report. The operating results in any quarter are not necessarily indicative of the results that may be expected for any future period (in thousands, except per share data). Quarter Ended 12/31/15 9/30/15 6/30/15 3/31/15 Net revenue $ 91,135 $ 91,259 $ 77,633 $ 70,770 Gross profit 84,668 83,552 69,328 64,395 Net income 17,011 26,128 7,314 8,023 Net income per common share: Basic $ 0.24 $ 0.36 $ 0.10 $ 0.11 Diluted $ 0.22 $ 0.34 $ 0.10 $ 0.11 Quarter Ended 12/31/14 9/30/14 6/30/14 3/31/14 Net revenue $ 66,512 $ 58,281 $ 55,696 $ 41,636 Gross profit 60,652 52,891 49,141 36,863 Net income 9,349 11,505 9,465 7,658 Net income per common share: Basic $ 0.13 $ 0.17 $ 0.14 $ 0.12 Diluted $ 0.13 $ 0.16 $ 0.13 $ 0.11 |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies [Abstract] | |
Consolidation, Policy [Policy Text Block] | Principles of Consolidation The consolidated financial statements include the accounts of Insys Therapeutics, Inc. and its wholly-owned subsidiary, Insys Pharma, Inc. (“Insys Pharma”). All significant intercompany balances and transactions have been eliminated in the accompanying consolidated financial statements. |
Reclassification, Policy [Policy Text Block] | Reclassification Certain amounts in prior periods have been reclassified to conform to the current period presentation. |
Fair Value Measurement, Policy [Policy Text Block] | Fair Value of Financial Instruments The carrying values of our financial instruments, including cash, accounts receivable and accounts payable approximate their fair value due to the short term nature of these financial instruments. Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“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. |
Revenue Recognition, Policy [Policy Text Block] | Revenue Recognition We recognize revenue from the sale of Subsys and Dronabinol SG Capsule. 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 Subsys was commercially launched in March 2012, and is available through a U.S. Food and Drug Administration (“FDA”) mandated Risk Evaluation and Mitigation program known as the Transmucosal Immediate Release Fentanyl program (“TIRF REMS”). We sell Subsys in the United States primarily to wholesale pharmaceutical distributors and to a lesser extent, specialty retail pharmacies, or collectively our customers, on a wholesale basis, 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. Given the limited sales history of prescriptions of Subsys prior to the fourth quarter of 2013, we were not able to reliably estimate expected returns of the product at the time of shipment prior to the fourth quarter of 2013. Accordingly, we initially deferred the recognition of revenue and related product costs of Subsys product shipments until the product was dispensed through patient prescriptions. The quantity of prescription units dispensed was estimated using an analysis of third-party information, including TIRF REMS mandated data and third-party market research data. Beginning in the fourth quarter of 2013, we were able to reasonably estimate product returns of Subsys. Therefore, we began recognizing revenue for Subsys sales at the time of shipment. Accordingly, in the fourth quarter of 2013, we recognized a one-time increase of $1.5 million in net product sales of Subsys, representing product sales previously deferred, net of estimated product returns, wholesaler discounts, prompt pay discounts, stocking allowances, patient discount programs, rebates, and chargebacks. Including deferred cost of sales, this change resulted in a one-time $0.9 million increase to operating income for the year ended December 31, 2013. 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 its 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 adjustments. The allowance for product returns is included in accrued sales allowances. Wholesaler Discounts Prompt Pay Discounts Stocking Allowances Patient Discount Programs Rebates Chargebacks. Dronabinol SG Capsule Dronabinol SG Capsule was commercially launched in December 2011, and we sold Dronabinol SG Capsule exclusively to Mylan Pharmaceuticals, Inc. (“Mylan”) in the United States under a former supply and distribution agreement. Pursuant to the terms of the Mylan agreement, we manufactured Dronabinol SG Capsule under the Mylan label. Mylan distributed Dronabinol SG Capsule and on a monthly basis paid us an amount equal to the value of Dronabinol SG Capsule it sold to wholesale pharmaceutical distributors, less contractually defined deductions for chargebacks, rebates, sales discounts, distribution and storage fees, and royalties. Under the terms of the supply and distribution agreement with Mylan, we were obligated to pay Mylan a royalty of between 10% and 20% on Mylan’s net product sales, and a single digit percentage fee on such sales for distribution and storage services. We bore no risk of product return upon acceptance by Mylan. As Mylan had control over the amount it charged to wholesale pharmaceutical distributors for Dronabinol SG Capsule and the discounts offered to the distributors, the sales price was not fixed and determinable at the date we shipped such products to Mylan. Accordingly, we recognized revenue upon Mylan’s sale of products to wholesale distributors, which was the point at which the sales price was fixed and determinable. We were involved in a dispute with Mylan that commenced in May 2013 and which ultimately led to an arbitration proceeding with the American Arbitration Association (Case No. 55 122 00119 13). In October 2015, we entered into a settlement agreement and full and final mutual and general release with Mylan which settled the claims in dispute and resulted in the termination of this relationship and confirmed the termination of the former supply and distribution agreement. We do not have any current plans to manufacture or market this product in the future. |
Cash and Cash Equivalents, Policy [Policy Text Block] | Cash and Cash Equivalents We consider all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents. The carrying value of those investments approximates their fair market value due to their short maturity and liquidity. Cash and cash equivalents include cash on hand and amounts on deposit with financial institutions, which at times may exceed FDIC limits. |
Investment, Policy [Policy Text Block] | 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, 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 |
Receivables, Policy [Policy Text Block] | Accounts Receivable, Net Trade accounts receivable are recorded at the invoice amount net of allowances for wholesaler discounts, prompt pay discounts, stocking allowances, and doubtful accounts. See “Revenue Recognition” above for a description of our wholesaler discounts, prompt pay discounts, stocking allowances and chargebacks. We evaluate the collectability of our accounts receivable based on a variety of factors including the length of time the receivables are past due, the financial health of the customer and historical experience. |
Inventory, Policy [Policy Text Block] | Inventories Inventories consist of raw materials, work-in-process and finished product and are valued at the lower of cost (first-in, first-out cost method) or market. Inventory costs are capitalized prior to regulatory approval and product launch based on management’s judgment of probable future commercial use and net realizable value of the inventory. Such judgment incorporates our knowledge and best estimate of where the relevant product is in the regulatory process, our required investment in the product, market conditions, competing products and our economic expectations for the product post-approval relative to the risk of manufacturing the product prior to approval. In evaluating the recoverability of inventories produced in preparation for product launches, we consider the probability that revenue will be obtained from the future sale of the related inventory together with the status of the product within the regulatory approval process, as well as the market for the product in its current state. We could be required to permanently write down previously capitalized costs related to pre-approval or pre-launch inventory upon a change in such judgment, due to a denial or delay of approval by regulatory bodies, a delay in commercialization, or other potential factors including product expiration. |
Property, Plant and Equipment, Policy [Policy Text Block] | Property and Equipment Property and equipment are recorded at cost and depreciated using the straight-line method over their estimated useful lives. Maintenance and repairs that do not extend the life of assets are charged to expense when incurred. When property and equipment is disposed of, the related costs and accumulated depreciation are removed from the accounts and any gain or loss is reported in the period the transaction takes place. Property and equipment are reviewed for impairment whenever events or changes in circumstances indicate the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to estimated undiscounted cash flows expected to be generated by the asset. If the carrying amount exceeds its estimated future undiscounted cash flows, an impairment charge is recognized by the amount by which the carrying amount exceeds the fair value of the asset. |
Income Tax, Policy [Policy Text Block] | Income Taxes We account for our deferred income tax assets and liabilities based on differences between the financial reporting and tax bases of assets and liabilities, and net operating loss carry forwards (the “NOLs”) and other tax credit carry forwards. These items are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in the period that includes the enactment date. We record a valuation allowance to reduce the deferred income tax assets to the amount that is more likely than not to be realized. In making such determinations, management considers all available positive and negative evidence, including scheduled reversals of deferred tax liabilities, projected future taxable income, tax planning strategies and recent financial operations. We recognize a tax benefit from uncertain tax positions when it is more likely than not that the position will be sustained upon examination, including resolutions of any related appeals or litigation processes, based on the technical merits of the position. Our policy is to classify interest and penalties associated with income tax liabilities as income tax expense in the statement of operations. |
Research and Development Expense, Policy [Policy Text Block] | Research and Development Expenses Research and development (“R&D”) costs are expensed when incurred. These costs consist of external research and development expenses incurred under agreements with third-party contract research organizations and investigative sites, third-party manufacturing organizations and consultants; employee-related expenses, which include salaries, benefits and stock-based compensation for the personnel involved in our preclinical and clinical drug development activities; and facilities expense, depreciation and other allocated expenses; and equipment and laboratory supplies. |
Advertising Costs, Policy [Policy Text Block] | Advertising and Marketing Advertising and marketing costs are expensed as incurred. Advertising expense totaled $1,166,000, $800,000 and $645,000 for the three years ending December 31, 2015, 2014 and 2013, respectively. |
Legal Costs, Policy [Policy Text Block] | Legal Fees Legal fees are expensed as incurred. Accordingly, we do not accrue for estimated future legal fees to be incurred in connection with litigation and other related legal matters. Legal expense totaled $19,448,000, $16,926,000 and $1,715,000 for the three years ending December 31, 2015, 2014 and 2013, respectively. |
Share-based Compensation, Option and Incentive Plans Policy [Policy Text Block] | Stock-Based Compensation Expenses Stock-based compensation cost is estimated at the grant date based on the fair value of the award, and the cost is recognized as expense ratably over the vesting period. We use the Black-Scholes option pricing model for estimating the grant date fair value of stock options using the following assumptions: ? Exercise price - Prior to May 7, 2013, we determined the exercise price based on valuations using the best information available to management at the time of the valuations. Subsequent to our initial public offering of common stock (“IPO”) on May 7, 2013, the exercise price is equal to the fair market value of the stock on the grant date which is determined based on quoted market prices. ? Volatility - Prior to our IPO, we did not have a reliable history of market prices for our common stock. Following our IPO, while we have an active trading market, we do not have sufficient historical data to accurately estimate volatility for the period equivalent to the expected term of the stock option grants. Accordingly, we estimate the expected stock price volatility for our common stock by taking the median historical stock price volatility for industry peers based on daily price observations over a period equivalent to the expected term of the stock option grants. ? Expected term - The expected term is based on a simplified method which defines the term as the average of the contractual term of the options and the weighted-average vesting period for all open employee awards. ? Risk-free rate - The risk-free interest rate for the expected term of the option is based on the average market rate on U.S. treasury securities in effect during the quarter in which the options were granted. ? Dividends - The dividend yield assumption is based on our history and expectation of paying no dividends. ? Forfeitures - Forfeitures have historically been insignificant. |
Use of Estimates, Policy [Policy Text Block] | Use of Estimates The preparation of financial statements in conformity with U.S. generally accepted accounting principles (“GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expense during the reporting period. Actual results could materially differ from those estimates. |
Segment Reporting, Policy [Policy Text Block] | Segment Information FASB ASC No. 280, “Segment Reporting” establishes standards for reporting information about reportable segments. Operating segments are defined as components of an enterprise about which separate financial information is available that is evaluated regularly by the chief operating decision maker, or decision-making group (“CODM”), in deciding how to allocate resources and in assessing performance. The CODM evaluates revenues and gross profits based on product lines and routes to market. Based on our integration and management strategies, we operate in a single reportable segment. |
New Accounting Pronouncements, Policy [Policy Text Block] | Recent Accounting Pronouncements In May 2014, the FASB issued Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers In August 2014, the FASB issued ASU No. 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern In July 2015, the FASB issued ASU No. 2015-11, Inventory (Topic 330): Simplifying the Measurement of Inventory In November 2015, the FASB issued ASU 2015-17, Income Taxes (Topic 470): Balance Sheet Classification of Deferred Taxes 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 |
Note 3 - Short-term and Long-22
Note 3 - Short-term and Long-term Investments (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Notes Tables | |
Available-for-sale Securities [Table Text Block] | December 31, 2015 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 December 31, 2014 Cost Unrealized Gains Unrealized Losses Other- Than- Temporary Impairment Losses Fair Value Cash and Cash Equivalents Short-term Investments Long-term Investments Cash $ 44,785 $ - $ - $ - $ 44,785 $ 44,785 $ - $ - Money market securities 13,321 - - - 13,321 13,321 - - Certificates of deposit 12,657 - - - 12,657 - 3,160 9,497 Marketable securities: - Corporate securities 10,837 - (26 ) - 10,811 - 6,229 4,582 Federal agency securities 9,512 - (10 ) - 9,502 - 5,009 4,493 Municipal securities 15,037 15 (3 ) - 15,049 - 10,359 4,690 Total marketable securities 35,386 15 (39 ) - 35,362 - 21,597 13,765 $ 106,149 $ 15 $ (39 ) $ - $ 106,125 $ 58,106 $ 24,757 $ 23,262 |
Schedule of Available-for-sale Securities Reconciliation [Table Text Block] | December 31, 2015 December 31, 2014 Amortized Cost Fair Value Amortized Cost Fair Value Marketable securities: Due in one year or less $ 66,148 $ 66,094 $ 21,597 $ 21,597 Due after one year through 5 years 33,731 33,633 13,789 13,765 Due after 5 years through 10 years - - - - Due after 10 years - - - - $ 99,879 $ 99,727 $ 35,386 $ 35,362 |
Schedule of Unrealized Loss on Investments [Table Text Block] | December 31, 2015 December 31, 2014 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 $ 25,137 $ (68 ) $ - $ - $ 9,809 $ (26 ) $ - $ - Federal agency securities 18,759 (65 ) - - 6,490 (10 ) - - Municipal securities 22,981 (35 ) - - 1,832 (3 ) - - $ 66,877 $ (168 ) $ - $ - $ 18,131 $ (39 ) $ - $ - |
Note 4 - Fair Value Measureme23
Note 4 - Fair Value Measurement (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Notes Tables | |
Fair Value, Assets Measured on Recurring Basis [Table Text Block] | 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: 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 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: Corporate securities $ 10,811 $ - $ 10,811 $ - Federal agency securities 9,502 - 9,502 - Municipal securities 15,049 - 15,049 - Total assets measured at fair value $ 35,362 $ - $ 35,362 $ - |
Note 5 - Inventories (Tables)
Note 5 - Inventories (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Notes Tables | |
Schedule of Inventory, Current [Table Text Block] | December 31, 2015 December 31, 2014 Finished goods $ 28,216 $ 30,998 Work-in-process 7,018 4,316 Raw materials and supplies 6,481 2,785 Total inventories 41,715 38,099 Less: non-current work-in-process - (3,318 ) $ 41,715 $ 34,781 |
Note 6 - Property and Equipme25
Note 6 - Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Notes Tables | |
Property, Plant and Equipment [Table Text Block] | Estimated Useful Life As of December 31, (in years) 2015 2014 Computer equipment 3 - 7 $ 2,798 $ 1,530 Scientific equipment 3 - 10 9,283 5,928 Furniture 3 - 10 2,022 1,545 Manufacturing equipment 7 - 10 19,536 13,101 Leasehold improvements * 16,771 16,688 Less: accumulated depreciation and amortization (12,028 ) (8,920 ) Total fixed assets $ 38,382 $ 29,872 |
Note 7 - Commitments and Cont26
Note 7 - Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Notes Tables | |
Schedule of Future Minimum Rental Payments for Operating Leases [Table Text Block] | Years ending December 31, 2016 $ 2,669 2017 2,612 2018 2,721 2019 2,799 2020 2,875 Thereafter 3,841 Total $ 17,517 |
Long-term Purchase Commitment [Table Text Block] | Years ending December 31, 2016 $ 2,000 2017 10,450 2018 14,650 2019 18,260 2020 20,840 Thereafter 4,330 Total $ 70,530 |
Note 9 - Stock-based Compensa27
Note 9 - Stock-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Notes Tables | |
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Table Text Block] | Years Ended December 31, 2015 2014 2013 Research and development $ 633 $ 5,498 $ 915 General and administrative 19,749 9,791 5,424 Total cost of stock-based compensation $ 20,382 $ 15,289 $ 6,339 |
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) Outstanding as of December 31, 2012 6,517,719 $ 1.06 Granted 4,460,100 $ 4.86 Cancelled (174,888 ) $ 2.86 Exercised (1,807,953 ) $ 1.15 Outstanding as of December 31, 2013 8,994,978 $ 2.90 Granted 3,397,198 $ 14.57 Cancelled (1,068,224 ) $ 7.71 Exercised (3,616,790 ) $ 2.48 Outstanding as of December 31, 2014 7,707,162 $ 7.57 Granted 1,733,671 $ 29.38 Cancelled (695,061 ) $ 17.03 Exercised (1,607,683 ) $ 5.89 $ 40.2 Outstanding as of December 31, 2015 7,138,089 $ 12.33 7.8 $ 118.7 Vested and exercisable as of December 31, 2015 3,722,736 $ 6.91 7.0 $ 81.1 |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | 2015 2014 2013 Expected volatility 69.9% 69.3% 73.5% Risk-free interest rate 1.9% 1.7% 2.0% Expected term (in years) 7.0 6.0 7.0 Expected dividend yield 0.0% 0.0% 0.0% |
Note 10 - Income Taxes (Tables)
Note 10 - Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Notes Tables | |
Schedule of Components of Income Tax Expense (Benefit) [Table Text Block] | Years Ended December 31, 2015 2014 2013 Current income taxes: Federal $ 32,039 $ 22,500 $ 2,281 State and local 6,572 3,874 957 Total current income tax 38,611 26,374 3,238 Deferred income taxes: Federal (2,997 ) 867 (9,123 ) State and local (1,122 ) (1,042 ) (2,915 ) Total deferred income tax (4,119 ) (175 ) (12,038 ) Income tax expense/(benefit) $ 34,492 $ 26,199 $ (8,800 ) |
Schedule of Deferred Tax Assets and Liabilities [Table Text Block] | Deferred income tax assets: 2015 2014 NOLs and credits $ 26,931 $ 24,683 Start-up expenditures 2,896 3,349 Stock-based compensation 8,578 4,351 Allowances 1,581 2,516 Expenses currently not deductible for tax purposes 5,640 3,884 Other 284 149 Gross deferred tax assets 45,910 38,932 Deferred income tax asset valuation allowance (20,191 ) (20,402 ) Deferred income tax assets 25,719 18,530 Deferred income tax liabilities: Federal impact of state taxes (1,778 ) (1,384 ) Property and equipment (6,189 ) (4,354 ) Prepaid expenses (1,421 ) (579 ) Net deferred income tax assets $ 16,331 $ 12,213 |
Schedule of Effective Income Tax Rate Reconciliation [Table Text Block] | 2015 2014 2013 U.S. statutory tax rate 35.0 % 35.0 % 35.0 % Increase (reduction) of income taxes resulting from: State income taxes, net of federal benefit 1.7 % 2.9 % 11.8 % Non-deductible litigation expense 4.3 % 3.0 % - Non-deductible and includible items and credits 0.8 % 0.6 % 2.3 % Research and other credits (4.6 )% (2.2 )% (1.8 )% Uncertain tax positions 2.7 % 1.8 % - Domestic manufacturing deduction (3.0 )% (0.3 )% - Other 0.4 % - (0.6 )% Change in valuation allowance (0.2 )% - (74.6 )% Total (benefit) provision for income taxes 37.1 % 40.8 % (27.9 )% |
Schedule of Unrecognized Tax Benefits Roll Forward [Table Text Block] | Years Ended December 31, 2015 2014 Beginning balance $ 5,366 $ 325 Additions based on current year's tax positions 3,885 450 Additions based on prior year's tax positions (240 ) 4,591 Ending balance $ 9,011 $ 5,366 |
Note 11 - Net Income Per Share
Note 11 - Net Income Per Share (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Notes Tables | |
Schedule of Earnings Per Share, Basic and Diluted [Table Text Block] | Years Ended December 31, 2015 2014 2013 Historical net income per share - Basic Numerator: Net income $ 58,476 $ 37,977 $ 40,377 Denominator: Weighted average number of common shares outstanding 71,592,581 68,759,070 51,839,536 Basic net income per common share $ 0.82 $ 0.55 $ 0.78 Historical net income per share - Diluted Numerator: Net income $ 58,476 $ 37,977 $ 40,377 Denominator: Weighted average number of common shares outstanding 71,592,581 68,759,070 51,839,536 Effect of dilutive stock options 4,115,070 4,576,062 5,629,698 Weighted average number of common shares outstanding 75,707,651 73,335,132 57,469,234 Diluted net income per common share $ 0.77 $ 0.52 $ 0.70 |
Note 12 - Product Lines, Conc30
Note 12 - Product Lines, Concentration of Credit Risk and Significant Customers (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Notes Tables | |
Revenue from External Customers by Products and Services [Table Text Block] | Net Revenue by Product Line Years Ended December 31, 2015 2014 2013 Subsys $ 329,514 $ 219,530 $ 95,740 Dronabinol SG Capsule 1,283 2,595 3,549 Total net revenue $ 330,797 $ 222,125 $ 99,289 |
Schedules of Concentration of Risk, by Risk Factor [Table Text Block] | Percent of Revenue by Route to Market Years Ended December 31, 2015 2014 2013 Pharmaceutical wholesalers 95 % 99 % 96 % Specialty pharmaceutical retailers 5 % 0 % 0 % Generic pharmaceutical distributors 0 % 1 % 4 % 100 % 100 % 100 % |
Note 13 - Supplemental Financ31
Note 13 - Supplemental Financial Information (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Notes Tables | |
Allowance for Credit Losses on Financing Receivables [Table Text Block] | Balance at Beginning of Year Charged to Costs and Expenses Utilization Balance at End of Year Allowance for doubtful accounts: Year ended December 31, 2015 $ 398 $ 413 $ - $ 811 Year ended December 31, 2014 $ - $ 398 $ - $ 398 Year ended December 31, 2013 $ - $ - $ - $ - Allowance for sales wholesaler discounts, prompt pay discounts, stocking allowances, and chargebacks: Year ended December 31, 2015 $ 5,418 $ 36,849 $ (35,898 ) $ 6,369 Year ended December 31, 2014 $ 2,748 $ 22,395 $ (19,725 ) $ 5,418 Year ended December 31, 2013 $ 834 $ 8,512 $ (6,598 ) $ 2,748 |
Note 14 - Quarterly Results o32
Note 14 - Quarterly Results of Operations (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Notes Tables | |
Schedule of Quarterly Financial Information [Table Text Block] | Quarter Ended 12/31/15 9/30/15 6/30/15 3/31/15 Net revenue $ 91,135 $ 91,259 $ 77,633 $ 70,770 Gross profit 84,668 83,552 69,328 64,395 Net income 17,011 26,128 7,314 8,023 Net income per common share: Basic $ 0.24 $ 0.36 $ 0.10 $ 0.11 Diluted $ 0.22 $ 0.34 $ 0.10 $ 0.11 Quarter Ended 12/31/14 9/30/14 6/30/14 3/31/14 Net revenue $ 66,512 $ 58,281 $ 55,696 $ 41,636 Gross profit 60,652 52,891 49,141 36,863 Net income 9,349 11,505 9,465 7,658 Net income per common share: Basic $ 0.13 $ 0.17 $ 0.14 $ 0.12 Diluted $ 0.13 $ 0.16 $ 0.13 $ 0.11 |
Note 1 - Nature of Business (De
Note 1 - Nature of Business (Details Textual) | 12 Months Ended |
Dec. 31, 2015 | |
Subsys [Member] | |
Number of Product Lines | 1 |
Dronabinol Sg Capsule [Member] | Discontinued Operations [Member] | |
Number of Product Lines | 1 |
Note 2 - Significant Accounti34
Note 2 - Significant Accounting Policies (Details Textual) - USD ($) | Oct. 30, 2015 | Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 30, 2014 | Dec. 31, 2013 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 |
Subsys [Member] | |||||||||||||
Revenues | $ 1,500,000 | $ 329,514,000 | $ 219,530,000 | $ 95,740,000 | |||||||||
Net Income (Loss) Attributable to Parent | 900,000 | ||||||||||||
Mylan Pharmaceuticals, Inc [Member] | Minimum [Member] | |||||||||||||
Royalty Obligation as Percentage of Net Sales | 10.00% | ||||||||||||
Mylan Pharmaceuticals, Inc [Member] | Maximum [Member] | |||||||||||||
Royalty Obligation as Percentage of Net Sales | 20.00% | ||||||||||||
Minimum [Member] | |||||||||||||
Royalty Obligation as Percentage of Net Sales | 1.00% | ||||||||||||
Cash and Cash Equivalents [Member] | |||||||||||||
Investment Owned, at Fair Value | $ 3,155,000 | $ 3,155,000 | |||||||||||
Short-term Investments [Member] | |||||||||||||
Investment Owned, at Fair Value | 79,576,000 | 79,576,000 | |||||||||||
Other Long-term Investments [Member] | |||||||||||||
Investment Owned, at Fair Value | 43,219,000 | 43,219,000 | |||||||||||
Realized Investment Gains (Losses) | 0 | ||||||||||||
Revenues | 330,797,000 | 222,125,000 | 99,289,000 | ||||||||||
Net Income (Loss) Attributable to Parent | $ 17,011,000 | $ 26,128,000 | $ 7,314,000 | $ 8,023,000 | $ 9,349 | $ 11,505 | $ 9,465 | $ 7,658 | $ 58,476,000 | 37,977,000 | 40,377,000 | ||
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% | 2.00% | |||||||||||
Investment Owned, at Fair Value | $ 202,310,000 | $ 106,125,000 | $ 202,310,000 | 106,125,000 | |||||||||
Advertising Expense | 1,166,000 | 800,000 | 645,000 | ||||||||||
Legal Fees | $ 19,448,000 | $ 16,926,000 | $ 1,715,000 |
Note 3 - Short-term and Long-35
Note 3 - Short-term and Long-term Investments - Summary of Investments (Details) - USD ($) | Dec. 31, 2015 | Dec. 31, 2014 |
Cash [Member] | ||
Amortized Cost | $ 55,987,000 | $ 44,785,000 |
Investment Owned, at Fair Value | 55,987,000 | 44,785,000 |
Cash and Cash Equivalents | 55,987,000 | 44,785,000 |
Money Market Funds [Member] | ||
Amortized Cost | 20,373,000 | 13,321,000 |
Investment Owned, at Fair Value | 20,373,000 | 13,321,000 |
Cash and Cash Equivalents | 20,373,000 | 13,321,000 |
Certificates of Deposit [Member] | ||
Amortized Cost | 26,223,000 | 12,657,000 |
Investment Owned, at Fair Value | 26,223,000 | 12,657,000 |
Short-term Investments | 16,637,000 | 3,160,000 |
Long-term Investments | 9,586,000 | 9,497,000 |
Corporate Debt Securities [Member] | ||
Amortized Cost | 27,186,000 | 10,837,000 |
Investment Owned, at Fair Value | 27,118,000 | 10,811,000 |
Cash and Cash Equivalents | 1,621,000 | |
Short-term Investments | 19,181,000 | 6,229,000 |
Long-term Investments | $ 6,316,000 | 4,582,000 |
Unrealized Gains | ||
Unrealized Losses | $ (68,000) | (26,000) |
US Government Agencies Debt Securities [Member] | ||
Amortized Cost | 18,823,000 | 9,512,000 |
Investment Owned, at Fair Value | 18,758,000 | 9,502,000 |
Short-term Investments | 10,129,000 | 5,009,000 |
Long-term Investments | $ 8,629,000 | 4,493,000 |
Unrealized Gains | ||
Unrealized Losses | $ (65,000) | (10,000) |
Municipal Bonds [Member] | ||
Amortized Cost | 53,870,000 | 15,037,000 |
Investment Owned, at Fair Value | 53,851,000 | 15,049,000 |
Cash and Cash Equivalents | 1,534,000 | |
Short-term Investments | 33,629,000 | 10,359,000 |
Long-term Investments | 18,688,000 | 4,690,000 |
Unrealized Gains | 16,000 | 15,000 |
Unrealized Losses | (35,000) | (3,000) |
Marketable Securities [Member] | ||
Amortized Cost | 99,879,000 | 35,386,000 |
Investment Owned, at Fair Value | 99,727,000 | 35,362,000 |
Cash and Cash Equivalents | 3,155,000 | |
Short-term Investments | 62,939,000 | 21,597,000 |
Long-term Investments | 33,633,000 | 13,765,000 |
Unrealized Gains | 16,000 | 15,000 |
Unrealized Losses | (168,000) | (39,000) |
Amortized Cost | 202,462,000 | 106,149,000 |
Investment Owned, at Fair Value | 202,310,000 | 106,125,000 |
Cash and Cash Equivalents | 79,515,000 | 58,106,000 |
Short-term Investments | 79,576,000 | 24,757,000 |
Long-term Investments | 43,219,000 | 23,262,000 |
Unrealized Gains | 16,000 | 15,000 |
Unrealized Losses | $ (168,000) | $ (39,000) |
Note 3 - Short-term and Long-36
Note 3 - Short-term and Long-term Investments - Amortized Cost and Estimated Fair Value of Securities (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Marketable securities: | ||
Due in one year or less | $ 66,148 | $ 21,597 |
Due in one year or less | 66,094 | 21,597 |
Due after one year through 5 years | 33,731 | 13,789 |
Due after one year through 5 years | $ 33,633 | $ 13,765 |
Due after 5 years through 10 years | ||
Due after 5 years through 10 years | ||
Due after 10 years | ||
Due after 10 years | ||
Total | $ 99,879 | $ 35,386 |
Total | $ 99,727 | $ 35,362 |
Note 3 - Short-term and Long-37
Note 3 - Short-term and Long-term Investments - Gross Unrealized Losses (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Corporate Bond Securities [Member] | ||
Marketable securities: | ||
Less Than 12 Months Fair Value | $ 25,137 | $ 9,809 |
Less Than 12 Months Unrealized Loss | $ (68) | $ (26) |
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 | $ 18,759 | $ 6,490 |
Less Than 12 Months Unrealized Loss | $ (65) | $ (10) |
Greater Than 12 Months Fair Value | ||
Greater Than 12 Months Unrealized Loss | ||
Municipal Bonds [Member] | ||
Marketable securities: | ||
Less Than 12 Months Fair Value | $ 22,981 | $ 1,832 |
Less Than 12 Months Unrealized Loss | $ (35) | $ (3) |
Greater Than 12 Months Fair Value | ||
Greater Than 12 Months Unrealized Loss | ||
Less Than 12 Months Fair Value | $ 66,877 | $ 18,131 |
Less Than 12 Months Unrealized Loss | $ (168) | $ (39) |
Greater Than 12 Months Fair Value | ||
Greater Than 12 Months Unrealized Loss |
Note 4 - Fair Value Measureme38
Note 4 - Fair Value Measurement - Investments Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
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 | $ 27,118 | $ 10,811 |
Corporate Debt Securities [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Available-for-sale securities | ||
Corporate Debt Securities [Member] | ||
Available-for-sale securities | $ 27,118 | $ 10,811 |
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 | $ 18,758 | $ 9,502 |
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 | $ 18,758 | $ 9,502 |
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 | $ 53,851 | $ 15,049 |
Municipal Bonds [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Available-for-sale securities | ||
Municipal Bonds [Member] | ||
Available-for-sale securities | $ 53,851 | $ 15,049 |
Fair Value, Inputs, Level 1 [Member] | ||
Available-for-sale securities | ||
Fair Value, Inputs, Level 2 [Member] | ||
Available-for-sale securities | $ 99,727 | $ 35,362 |
Fair Value, Inputs, Level 3 [Member] | ||
Available-for-sale securities | ||
Available-for-sale securities | $ 99,727 | $ 35,362 |
Note 5 - Inventories - Componen
Note 5 - Inventories - Components of Inventories (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Finished goods | $ 28,216 | $ 30,998 |
Work-in-process | 7,018 | 4,316 |
Raw materials and supplies | 6,481 | 2,785 |
Total inventories | $ 41,715 | 38,099 |
Less: non-current work-in-process | (3,318) | |
Inventories, net | $ 41,715 | $ 34,781 |
Note 6 - Property and Equipme40
Note 6 - Property and Equipment (Details Textual) - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Depreciation, Depletion and Amortization | $ 5,295,000 | $ 2,500,000 | $ 1,788,000 |
Note 6 - Property and Equipme41
Note 6 - Property and Equipment (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | ||
Computer Equipment [Member] | Minimum [Member] | |||
Estimated Useful Life | 3 years | ||
Computer Equipment [Member] | Maximum [Member] | |||
Estimated Useful Life | 7 years | ||
Computer Equipment [Member] | |||
Property, Plant and Equipment, gross | $ 2,798 | $ 1,530 | |
Equipment [Member] | Minimum [Member] | |||
Estimated Useful Life | 3 years | ||
Equipment [Member] | Maximum [Member] | |||
Estimated Useful Life | 10 years | ||
Equipment [Member] | |||
Property, Plant and Equipment, gross | $ 9,283 | 5,928 | |
Furniture and Fixtures [Member] | Minimum [Member] | |||
Estimated Useful Life | 3 years | ||
Furniture and Fixtures [Member] | Maximum [Member] | |||
Estimated Useful Life | 10 years | ||
Furniture and Fixtures [Member] | |||
Property, Plant and Equipment, gross | $ 2,022 | 1,545 | |
Manufacturing Equipment [Member] | Minimum [Member] | |||
Estimated Useful Life | 7 years | ||
Manufacturing Equipment [Member] | Maximum [Member] | |||
Estimated Useful Life | 10 years | ||
Manufacturing Equipment [Member] | |||
Property, Plant and Equipment, gross | $ 19,536 | 13,101 | |
Leasehold Improvements [Member] | |||
Estimated Useful Life | [1] | ||
Property, Plant and Equipment, gross | [1] | $ 16,771 | 16,688 |
Less: accumulated depreciation and amortization | (12,028) | (8,920) | |
Total fixed assets | $ 38,382 | $ 29,872 | |
[1] | The estimated useful life of the leasehold improvements is the lesser of the lease term or the estimated useful life. |
Note 7 - Commitments and Cont42
Note 7 - Commitments and Contingencies (Details Textual) - USD ($) | Jan. 26, 2016 | Nov. 01, 2015 | Oct. 30, 2015 | Oct. 02, 2015 | Aug. 30, 2015 | Jun. 23, 2015 | Jun. 08, 2015 | Jun. 30, 2015 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Sep. 30, 2015 |
Minimum [Member] | Wayne Automatic Fire Sprinklers [Member] | Threatened Litigation [Member] | ||||||||||||
Loss Contingency, Damages Sought, Value | $ 75,000 | |||||||||||
Minimum [Member] | ||||||||||||
Royalty Obligation as Percentage of Net Sales | 1.00% | |||||||||||
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 | |||||||||||
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 | |||||||||||
Kottayil vs. Insys Pharma, Inc. [Member] | Threatened Litigation [Member] | ||||||||||||
Loss Contingency, Damages Sought, Value | $ 3,630,000 | |||||||||||
Loss Contingency, Range of Possible Loss, Minimum | 0 | |||||||||||
Loss Contingency, Range of Possible Loss, Maximum | $ 3,630,000 | |||||||||||
Wayne Automatic Fire Sprinklers [Member] | Threatened Litigation [Member] | ||||||||||||
Alleged Benfits Erroneously Paid By Health Benifit Plan | $ 198,000 | |||||||||||
Defined Contribution Plan, Employer Matching Contribution, Percent of Employees' Gross Pay | 6.00% | |||||||||||
Term of Aptargroup, Inc Joint Agreement | 7 years | |||||||||||
Operating Leases, Rent Expense, Net | $ 2,445,000 | $ 1,698,000 | $ 498,000 | |||||||||
Defined Contribution Plan, Employer Matching Contribution, Percent of Match | 50.00% | |||||||||||
Litigation Settlement, Expense | $ 9,515,000 |
Note 7 - Commitments and Cont43
Note 7 - Commitments and Contingencies - Future Minimum Purchase Commitments (Details) $ in Thousands | Dec. 31, 2015USD ($) |
Years ending December 31, | |
2,016 | $ 2,669 |
2,017 | 2,612 |
2,018 | 2,721 |
2,019 | 2,799 |
2,020 | 2,875 |
Thereafter | 3,841 |
Total | $ 17,517 |
Note 7 - Future Minimum Purchas
Note 7 - Future Minimum Purchase Commitments (Details) $ in Thousands | Dec. 31, 2015USD ($) |
2,016 | $ 2,000 |
2,017 | 10,450 |
2,018 | 14,650 |
2,019 | 18,260 |
2,020 | 20,840 |
Thereafter | 4,330 |
Total | $ 70,530 |
Note 8 - Equity (Details Textua
Note 8 - Equity (Details Textual) | Nov. 03, 2015USD ($)shares | May. 05, 2015$ / sharesshares | Aug. 31, 2014$ / shares | May. 07, 2013USD ($)$ / sharesshares | Feb. 26, 2014$ / sharesshares | Dec. 31, 2015USD ($)$ / sharesshares | Dec. 31, 2014USD ($)$ / sharesshares | Dec. 31, 2013USD ($)shares | May. 06, 2014$ / sharesshares | May. 05, 2014shares |
Common Class A [Member] | ||||||||||
Preferred Stock, Par or Stated Value Per Share | $ / shares | $ 0.001 | |||||||||
Preferred Stock Purchase Price | 160 | |||||||||
Minimum Ownership Percentage Acquired to Trigger Preferred Stock Purchase Rights | 15.00% | |||||||||
Preferred Stock, Dividend Rate, Per-Dollar-Amount | $ / shares | $ 1 | |||||||||
Multiple used to Determine Preferred Stock Dividend | 100 | |||||||||
Preferred Stock, Liquidation Preference Per Share | $ / shares | $ 100 | |||||||||
Number of Votes for each Preferred Share | 100 | |||||||||
Stock Split From [Member] | ||||||||||
Stockholders' Equity Note, Stock Split, Conversion Ratio | 3 | |||||||||
Stock Split To [Member] | ||||||||||
Stockholders' Equity Note, Stock Split, Conversion Ratio | 2 | |||||||||
Pre-split Basis [Member] | Convertible Preferred Stock [Member] | ||||||||||
Stock Issued During Period, Shares, Conversion of Convertible Securities | 8,528,860 | |||||||||
Pre-split Basis [Member] | Kapoor Notes [Member] | ||||||||||
Stock Issued During Period, Shares, Conversion of Convertible Securities | 7,410,341 | |||||||||
Pre-split Basis [Member] | ||||||||||
Common Stock, Par or Stated Value Per Share | $ / shares | $ 0.0002145 | |||||||||
Stock Issued During Period, Shares, New Issues | 4,600,000 | |||||||||
Share Price | $ / shares | $ 8 | |||||||||
Convertible Preferred Stock [Member] | ||||||||||
Stock Issued During Period, Shares, New Issues | ||||||||||
Stock Issued During Period, Shares, Conversion of Convertible Securities | 25,586,590 | (14,864,607) | ||||||||
Treasury Stock, Shares, Acquired | ||||||||||
Kapoor Notes [Member] | ||||||||||
Stock Issued During Period, Shares, Conversion of Convertible Securities | 22,231,024 | |||||||||
Debt Conversion, Original Debt, Amount | $ | $ 59,284,000 | |||||||||
Preferred Stock, Par or Stated Value Per Share | $ / shares | $ 0.01 | $ 0.01 | ||||||||
Stockholders' Equity Note, Stock Split, Conversion Ratio | 2 | |||||||||
Stock Issued during Period Per Share, Stock Split | 1 | 1 | ||||||||
Common Stock, Par or Stated Value Per Share | $ / shares | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 | ||||||
Common Stock, Shares Authorized | 100,000,000 | 100,000,000 | 100,000,000 | 50,000,000 | ||||||
Stock Issued During Period, Shares, New Issues | 13,800,000 | |||||||||
Share Price | $ / shares | $ 2.67 | |||||||||
Proceeds from Issuance Initial Public Offering | $ | $ 32,500,000 | $ 32,456,000 | ||||||||
Underwriting Discounts and Commissions for Public Offering | $ | 2,600,000 | |||||||||
Offering Expenses for Public Offering | $ | $ 1,800,000 | |||||||||
Stock Repurchase Program, Authorized Amount | $ | $ 50,000,000 | |||||||||
Treasury Stock, Shares, Acquired | 560,200 | |||||||||
Treasury Stock, Value, Acquired, Cost Method | $ | $ 16,459,000 |
Note 9 - Stock-based Compensa46
Note 9 - Stock-based Compensation (Details Textual) - USD ($) | 12 Months Ended | |||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Employee Stock Purchase Plan 2013 [Member] | Pre-split Basis [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 175,000 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Additional Annual Shares Automatically Authorized, Period Increase, Option Shares | 200,000 | |||
Employee Stock Purchase Plan 2013 [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Maximum Employee Subscription Rate | 15.00% | |||
Share-based Compensation Arrangement by Share-based Payment Award, Discount from Market Price, Offering Date | 85.00% | |||
Share-based Compensation Arrangement by Share-based Payment Award, Discount from Market Price, Purchase Date | 85.00% | |||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 530,400 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Additional Shares Authorized, Annual Automatic Increase, Percent | 1.00% | |||
Share-based Compensation Arrangement by Share-based Payment Award, Additional Annual Shares Automatically Authorized, Period Increase, Option Shares | 600,000 | |||
Stock Issued During Period, Shares, Employee Stock Purchase Plans | 1,244,130 | |||
Equity Incentive Plan Twenty Thirteen [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Additional Shares Authorized, Annual Automatic Increase, Percent | 4.00% | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 7,138,089 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 2,183,946 | |||
Share-based Compensation Arrangement by Share-based Payment Award Accelerated Compensation Cost | $ 4,867,000 | $ 4,016,000 | $ 0 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 7,138,089 | 7,707,162 | 8,994,978 | 6,517,719 |
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Stock Options | $ 41,370,000 | |||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 2 years 328 days | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested in Period, Fair Value | $ 25,392,000 | $ 14,572,000 | $ 5,785,000 | |
Proceeds from Stock Options Exercised | 9,524,000 | 8,956,000 | 2,102,000 | |
Employee Service Share-based Compensation, Tax Benefit from Compensation Expense | $ 13,593,000 | $ 22,003,000 | $ 2,745,000 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 19.20 | $ 10.53 | $ 5.04 |
Note 9 - Stock-based Compensa47
Note 9 - Stock-based Compensation - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Research and Development Expense [Member] | |||
Allocated share-based compensation expense | $ 633 | $ 5,498 | $ 915 |
General and Administrative Expense [Member] | |||
Allocated share-based compensation expense | 19,749 | 9,791 | 5,424 |
Allocated share-based compensation expense | $ 20,382 | $ 15,289 | $ 6,339 |
Note 9 - Stock-based Compensa48
Note 9 - Stock-based Compensation - Stock Option Activity (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Outstanding (in shares) | 7,707,162 | 8,994,978 | 6,517,719 |
Outstanding (in dollars per share) | $ 7.57 | $ 2.90 | $ 1.06 |
Granted (in shares) | 1,733,671 | 3,397,198 | 4,460,100 |
Granted (in dollars per share) | $ 29.38 | $ 14.57 | $ 4.86 |
Cancelled (in shares) | (695,061) | (1,068,224) | (174,888) |
Cancelled (in dollars per share) | $ 17.03 | $ 7.71 | $ 2.86 |
Exercised (in shares) | (1,607,683) | (3,616,790) | (1,807,953) |
Exercised (in dollars per share) | $ 5.89 | $ 2.48 | $ 1.15 |
Outstanding (in shares) | 7,138,089 | 7,707,162 | 8,994,978 |
Outstanding (in dollars per share) | $ 12.33 | $ 7.57 | $ 2.90 |
Exercised | $ 40.2 | ||
Outstanding | 7 years 292 days | ||
Outstanding | $ 118.7 | ||
Vested and exercisable as of December 31, 2015 (in shares) | 3,722,736 | ||
Vested and exercisable as of December 31, 2015 (in dollars per share) | $ 6.91 | ||
Vested and exercisable as of December 31, 2015 | 7 years | ||
Vested and exercisable as of December 31, 2015 | $ 81.1 |
Note 9 - Stock-based Compensa49
Note 9 - Stock-based Compensation - Fair Value Assumptions (Details) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Expected volatility | 69.90% | 69.30% | 73.50% |
Risk-free interest rate | 1.90% | 1.70% | 2.00% |
Expected term (in years) | 7 years | 6 years | 7 years |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Note 10 - Income Taxes (Details
Note 10 - Income Taxes (Details Textual) - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Domestic Tax Authority [Member] | |||
Operating Loss Carryforwards | $ 1,200,000 | ||
State and Local Jurisdiction [Member] | Illinois [Member] | Excluded from State Tax Net Operating Loss [Member] | |||
Deferred Tax Assets, Operating Loss Carryforwards, State and Local | 1,700,000 | ||
State and Local Jurisdiction [Member] | Illinois [Member] | |||
Deferred Tax Assets, Operating Loss Carryforwards, State and Local | 268,300,000 | ||
Deferred Tax Assets, Operating Loss Carryforwards, State and Local, Not Utilized | 259,400,000 | ||
Deferred Tax Assets, Valuation Allowance | 20,200,000 | ||
Tax Credits [Member] | |||
Unrecognized Tax Benefits | 1,971,000 | ||
State and Local Income Tax Filing Positions [Member] | |||
Unrecognized Tax Benefits | 5,360,000 | ||
Other Permanent Differences [Member] | |||
Unrecognized Tax Benefits | 1,680,000 | ||
Deferred Tax Assets, Valuation Allowance | $ 20,191,000 | $ 20,402,000 | |
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 35.00% | 35.00% | 35.00% |
Effective Income Tax Rate Reconciliation, Percent | 37.10% | 40.80% | (27.90%) |
Unrecognized Tax Benefits | $ 9,011,000 | $ 5,366,000 | $ 325,000 |
Unrecognized Tax Benefits, Interest on Income Taxes Accrued | $ 406,000 |
Note 10 - Income Taxes - Income
Note 10 - Income Taxes - Income Tax (Benefit) Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Current income taxes: | |||
Federal | $ 32,039 | $ 22,500 | $ 2,281 |
State and local | 6,572 | 3,874 | 957 |
Total current income tax | 38,611 | 26,374 | 3,238 |
Deferred income taxes: | |||
Federal | (2,997) | 867 | (9,123) |
State and local | (1,122) | (1,042) | (2,915) |
Total deferred income tax | (4,119) | (175) | (12,038) |
Income tax expense/(benefit) | $ 34,492 | $ 26,199 | $ (8,800) |
Note 10 - Income Taxes - Deferr
Note 10 - Income Taxes - Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Deferred income tax assets: | ||
NOLs and credits | $ 26,931 | $ 24,683 |
Start-up expenditures | 2,896 | 3,349 |
Stock-based compensation | 8,578 | 4,351 |
Allowances | 1,581 | 2,516 |
Expenses currently not deductible for tax purposes | 5,640 | 3,884 |
Other | 284 | 149 |
Gross deferred tax assets | 45,910 | 38,932 |
Deferred income tax asset valuation allowance | (20,191) | (20,402) |
Deferred income tax assets | 25,719 | 18,530 |
Deferred income tax liabilities: | ||
Federal impact of state taxes | (1,778) | (1,384) |
Property and equipment | (6,189) | (4,354) |
Prepaid expenses | (1,421) | (579) |
Net deferred income tax assets | $ 16,331 | $ 12,213 |
Note 10 - Income Taxes - Effect
Note 10 - Income Taxes - Effective Tax Rate Reconciliation (Details) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 35.00% | 35.00% | 35.00% |
Increase (reduction) of income taxes resulting from: | |||
State income taxes, net of federal benefit | 1.70% | 2.90% | 11.80% |
Non-deductible litigation expense | 4.30% | 3.00% | |
Non-deductible and includible items and credits | 0.80% | 0.60% | 2.30% |
Research and other credits | (4.60%) | (2.20%) | (1.80%) |
Uncertain tax positions | 2.70% | 1.80% | |
Domestic manufacturing deduction | (3.00%) | (0.30%) | |
Other | 0.40% | (0.60%) | |
Change in valuation allowance | (0.20%) | (74.60%) | |
Total (benefit) provision for income taxes | 37.10% | 40.80% | (27.90%) |
Note 10 - Income Taxes - Beginn
Note 10 - Income Taxes - Beginning and Ending Amounts of Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Beginning balance | $ 5,366 | $ 325 |
Additions based on current year's tax positions | 3,885 | 450 |
Additions based on prior year's tax positions | (240) | 4,591 |
Ending balance | $ 9,011 | $ 5,366 |
Note 11 - Net Income Per Shar55
Note 11 - Net Income Per Share (Details Textual) - shares | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 1,460,986 | 1,780,372 | 0 |
Note 11 - Net Income Per Shar56
Note 11 - Net Income Per Share - Computation of Basic and Diluted Net Income (Loss) Per Common Share (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Historical net income per share - Basic | |||
Net Income (Loss) Attributable to Parent | $ 58,476,000 | $ 37,977,000 | $ 40,377,000 |
Basic (in shares) | 71,592,581 | 68,759,070 | 51,839,536 |
Basic net income per common share (in dollars per share) | $ 0.82 | $ 0.55 | $ 0.78 |
Historical net income per share - Diluted | |||
Net Income (Loss) Attributable to Parent | $ 58,476,000 | $ 37,977,000 | $ 40,377,000 |
Weighted average number of common shares outstanding (in shares) | 71,592,581 | 68,759,070 | 51,839,536 |
Effect of dilutive stock options (in shares) | 4,115,070 | 4,576,062 | 5,629,698 |
Weighted average number of common shares outstanding (in shares) | 75,707,651 | 73,335,132 | 57,469,234 |
Diluted net income per common share (in dollars per share) | $ 0.77 | $ 0.52 | $ 0.70 |
Note 12 - Product Lines, Conc57
Note 12 - Product Lines, Concentration of Credit Risk and Significant Customers (Details Textual) | 12 Months Ended | ||
Dec. 31, 2015USD ($) | Dec. 31, 2014 | Dec. 31, 2013 | |
Subsys [Member] | |||
Number of Product Lines | 1 | ||
Dronabinol Sg Capsule [Member] | Discontinued Operations [Member] | |||
Number of Product Lines | 1 | ||
Product Shipments [Member] | Pharmaceutical Wholesalers [Member] | Customer One [Member] | |||
Concentration Risk, Percentage | 32.00% | 38.00% | 30.00% |
Product Shipments [Member] | Pharmaceutical Wholesalers [Member] | Customer Two [Member] | |||
Concentration Risk, Percentage | 20.00% | 22.00% | 21.00% |
Product Shipments [Member] | Pharmaceutical Wholesalers [Member] | Customer Three [Member] | |||
Concentration Risk, Percentage | 17.00% | 14.00% | 20.00% |
Product Shipments [Member] | Pharmaceutical Wholesalers [Member] | Customer Four [Member] | |||
Concentration Risk, Percentage | 14.00% | 14.00% | 19.00% |
Product Shipments [Member] | Pharmaceutical Wholesalers [Member] | |||
Concentration Risk, Number of Customers | 4 | 4 | 4 |
Accounts Receivable [Member] | Pharmaceutical Wholesalers [Member] | Customer One [Member] | |||
Concentration Risk, Percentage | 20.00% | 26.00% | |
Accounts Receivable [Member] | Pharmaceutical Wholesalers [Member] | Customer Two [Member] | |||
Concentration Risk, Percentage | 19.00% | 24.00% | |
Accounts Receivable [Member] | Pharmaceutical Wholesalers [Member] | Customer Three [Member] | |||
Concentration Risk, Percentage | 17.00% | 23.00% | |
Accounts Receivable [Member] | Pharmaceutical Wholesalers [Member] | Customer Four [Member] | |||
Concentration Risk, Percentage | 14.00% | 14.00% | |
Accounts Receivable [Member] | Pharmaceutical Wholesalers [Member] | |||
Concentration Risk, Number of Customers | 4 | 4 | |
Concentration Risk, Percentage | 100.00% | 100.00% | 100.00% |
Cash, FDIC Insured Amount | $ 250,000 |
Note 12 - Product Lines, Conc58
Note 12 - Product Lines, Concentration of Credit Risk and Significant Customers - Summary of Net Revenue by Product Line and Percentages (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Subsys [Member] | |||
Revenues | $ 329,514,000 | $ 219,530,000 | $ 95,740,000 |
Dronabinol Sg Capsule [Member] | |||
Revenues | 1,283,000 | 2,595,000 | 3,549,000 |
Revenues | $ 330,797,000 | $ 222,125,000 | $ 99,289,000 |
Note 12 - Product Lines, Conc59
Note 12 - Product Lines, Concentration of Credit Risk and Significant Customers - Percentage of Revenue by Route to Market (Details) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Sales Revenue, Product Line [Member] | Pharmaceutical Wholesalers [Member] | Product Concentration Risk [Member] | |||
Concentration Risk, Percentage | 95.00% | 99.00% | 96.00% |
Sales Revenue, Product Line [Member] | Specialty Pharmaceutical Retailers [Member] | Product Concentration Risk [Member] | |||
Concentration Risk, Percentage | 5.00% | 0.00% | 0.00% |
Sales Revenue, Product Line [Member] | Generic Pharmaceutical Distributor [Member] | Product Concentration Risk [Member] | |||
Concentration Risk, Percentage | 0.00% | 1.00% | 4.00% |
Concentration Risk, Percentage | 100.00% | 100.00% | 100.00% |
Note 13 - Supplemental Financ60
Note 13 - Supplemental Financial Information - Allowances for Accounts Receivables (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Allowance for Doubtful Accounts [Member] | |||
Balance at Beginning of Year | $ 398 | ||
Charged to Costs and Expenses | $ 413 | $ 398 | |
Utilization | |||
Balance at End of Year | $ 811 | $ 398 | |
Allowance for Sales Wholesaler Discountss Prompt Pay Discountss Stocking Allowancess and Chargebacks [Member] | |||
Balance at Beginning of Year | 5,418 | 2,748 | $ 834 |
Charged to Costs and Expenses | 36,849 | 22,395 | 8,512 |
Utilization | (35,898) | (19,725) | (6,598) |
Balance at End of Year | $ 6,369 | $ 5,418 | $ 2,748 |
Note 14 - Quarterly Results o61
Note 14 - Quarterly Results of Operations (Unaudited) (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 30, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Net revenue | $ 91,135,000 | $ 91,259,000 | $ 77,633,000 | $ 70,770,000 | $ 66,512 | $ 58,281 | $ 55,696 | $ 41,636 | $ 330,797,000 | $ 222,125,000 | $ 99,289,000 |
Gross profit | 84,668,000 | 83,552,000 | 69,328,000 | 64,395,000 | 60,652 | 52,891 | 49,141 | 36,863 | 301,943,000 | 199,547,000 | 86,624,000 |
Net Income (Loss) Attributable to Parent | $ 17,011,000 | $ 26,128,000 | $ 7,314,000 | $ 8,023,000 | $ 9,349 | $ 11,505 | $ 9,465 | $ 7,658 | $ 58,476,000 | $ 37,977,000 | $ 40,377,000 |
Basic (in dollars per share) | $ 0.24 | $ 0.36 | $ 0.10 | $ 0.11 | $ 0.13 | $ 0.17 | $ 0.14 | $ 0.12 | $ 0.82 | $ 0.55 | $ 0.78 |
Diluted (in dollars per share) | $ 0.22 | $ 0.34 | $ 0.10 | $ 0.11 | $ 0.13 | $ 0.16 | $ 0.13 | $ 0.11 | $ 0.77 | $ 0.52 | $ 0.70 |