Document And Entity Information
Document And Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2016 | Mar. 28, 2017 | Jun. 30, 2016 | |
Document And Entity Information [Abstract] | |||
Entity Registrant Name | Insys Therapeutics, Inc. | ||
Entity Central Index Key | 1,516,479 | ||
Trading Symbol | insy | ||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2016 | ||
Document Fiscal Year Focus | 2,016 | ||
Document Fiscal Period Focus | FY | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Filer Category | Accelerated Filer | ||
Entity Common Stock, Shares Outstanding (in shares) | 71,957,343 | ||
Entity Public Float | $ 300 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Current Assets: | ||
Cash and cash equivalents | $ 104,642 | $ 79,515 |
Short-term investments | 78,238 | 79,576 |
Accounts receivable, net of allowances of $6,144 and $8,367 at December 31, 2016 and 2015, respectively | 20,654 | 47,272 |
Inventories | 21,743 | 41,715 |
Prepaid expenses and other current assets | 5,695 | 3,973 |
Total current assets | 230,972 | 252,051 |
Property and equipment, net | 43,172 | 38,382 |
Long-term investments | 53,796 | 43,219 |
Deferred income tax assets, net | 23,243 | 17,607 |
Other assets | 4,953 | 26 |
Total assets | 356,136 | 351,285 |
Current Liabilities: | ||
Accounts payable and accrued expenses | 27,359 | 35,611 |
Accrued compensation | 8,833 | 10,225 |
Accrued sales allowances | 28,955 | 35,033 |
Accrued litigation awards and settlements | 13,467 | 9,567 |
Total current liabilities | 78,614 | 90,436 |
Uncertain income tax position | 7,933 | 8,544 |
Total liabilities | 86,547 | 98,980 |
Commitments and Contingencies (Note 7) | ||
Stockholders' Equity: | ||
Preferred stock (par value $0.01 per share; 10,000,000 shares authorized; 0 shares issued and outstanding as of December 31, 2016 and 2015, respectively) | 0 | 0 |
Common stock (par value $0.01 per share; 100,000,000 shares authorized; 71,923,550 and 71,907,858 shares issued and outstanding as of December 31, 2016 and 2015, respectively) | 719 | 719 |
Additional paid in capital | 256,529 | 246,685 |
Unrealized loss on available-for-sale securities, net of tax | (302) | (152) |
Notes receivable from stockholders | (21) | (21) |
Retained earnings | 12,664 | 5,074 |
Total stockholders' equity | 269,589 | 252,305 |
Total liabilities and stockholders' equity | $ 356,136 | $ 351,285 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Statement Of Financial Position [Abstract] | ||
Accounts receivable, allowance for doubtful accounts | $ 6,144 | $ 8,367 |
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) | 71,923,550 | 71,907,858 |
Common stock, shares outstanding (in shares) | 71,923,550 | 71,907,858 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Income - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Income Statement [Abstract] | |||
Net revenue | $ 242,275,000 | $ 330,323,000 | $ 219,092,000 |
Cost of revenue | 25,393,000 | 28,854,000 | 22,578,000 |
Gross profit | 216,882,000 | 301,469,000 | 196,514,000 |
Operating expenses: | |||
Sales and marketing | 69,651,000 | 80,668,000 | 58,105,000 |
Research and development | 73,913,000 | 56,781,000 | 33,136,000 |
General and administrative | 62,092,000 | 62,948,000 | 44,283,000 |
Charges related to litigation award and settlements | 3,900,000 | 10,616,000 | |
Total operating expenses | 209,556,000 | 211,013,000 | 135,524,000 |
Operating income | 7,326,000 | 90,456,000 | 60,990,000 |
Other income: | |||
Interest income | 1,039,000 | 502,000 | 151,000 |
Other income, net | 59,000 | 36,000 | 2,000 |
Total other income | 1,098,000 | 538,000 | 153,000 |
Income before income taxes | 8,424,000 | 90,994,000 | 61,143,000 |
Less: income tax expense | 834,000 | 32,941,000 | 25,089,000 |
Net income | 7,590,000 | 58,053,000 | 36,054,000 |
Unrealized loss on available-for-sale securities, net of tax | (150,000) | (128,000) | (24,000) |
Total comprehensive income | $ 7,440,000 | $ 57,925,000 | $ 36,030,000 |
Net income per common share: | |||
Basic | $ 0.11 | $ 0.81 | $ 0.52 |
Diluted | $ 0.10 | $ 0.77 | $ 0.49 |
Weighted average common shares outstanding | |||
Basic | 71,618,793 | 71,592,581 | 68,759,070 |
Diluted | 74,145,918 | 75,707,651 | 73,335,132 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Net Investment Gain (Loss) Attributable to Parent [Member] | Receivables from Stockholder [Member] | Retained Earnings [Member] |
Balance (in shares) at Dec. 31, 2013 | 66,369,784 | |||||
Balance at Dec. 31, 2013 | $ 79,477 | $ 664 | $ 167,867 | $ (21) | $ (89,033) | |
Exercise of stock options (in shares) | 3,616,790 | 3,616,790 | ||||
Exercise of stock options | $ 8,956 | $ 36 | 8,920 | |||
Issuance of common stock- employee stock purchase plan (in shares) | 716,114 | |||||
Issuance of common stock- employee stock purchase plan | 1,989 | $ 7 | 1,982 | |||
Excess tax benefits on stock options and awards | 21,449 | 21,449 | ||||
Stock based compensation - stock options and awards | 15,289 | 15,289 | ||||
Unrealized loss on available-for-sale securities, net of tax | (24) | $ (24) | ||||
Net income | 36,054 | 36,054 | ||||
Balance (in shares) at Dec. 31, 2014 | 70,702,688 | |||||
Balance at Dec. 31, 2014 | $ 163,190 | $ 707 | 215,507 | (24) | (21) | (52,979) |
Exercise of stock options (in shares) | 1,607,683 | 1,607,683 | ||||
Exercise of stock options | $ 9,524 | $ 16 | 9,508 | |||
Issuance of common stock- employee stock purchase plan (in shares) | 151,906 | |||||
Issuance of common stock- employee stock purchase plan | 2,647 | $ 2 | 2,645 | |||
Excess tax benefits on stock options and awards | 13,596 | 13,596 | ||||
Stock based compensation - stock options and awards (in shares) | 5,781 | |||||
Stock based compensation - stock options and awards | 21,882 | 21,882 | ||||
Unrealized loss on available-for-sale securities, net of tax | $ (128) | (128) | ||||
Repurchase of common stock (in shares) | (560,200) | (560,200) | ||||
Repurchase of common stock | $ (16,459) | $ (6) | (16,453) | |||
Net income | 58,053 | 58,053 | ||||
Balance (in shares) at Dec. 31, 2015 | 71,907,858 | |||||
Balance at Dec. 31, 2015 | $ 252,305 | $ 719 | 246,685 | (152) | (21) | 5,074 |
Exercise of stock options (in shares) | 637,721 | 637,721 | ||||
Exercise of stock options | $ 3,803 | $ 6 | 3,797 | |||
Issuance of common stock- employee stock purchase plan (in shares) | 221,046 | |||||
Issuance of common stock- employee stock purchase plan | 2,280 | $ 2 | 2,278 | |||
Tax deficiency on stock options and awards | (1,729) | (1,729) | ||||
Stock based compensation - stock options and awards | 21,589 | 21,589 | ||||
Unrealized loss on available-for-sale securities, net of tax | $ (150) | (150) | ||||
Repurchase of common stock (in shares) | (843,075) | (843,075) | ||||
Repurchase of common stock | $ (16,099) | $ (8) | (16,091) | |||
Net income | 7,590 | 7,590 | ||||
Balance (in shares) at Dec. 31, 2016 | 71,923,550 | |||||
Balance at Dec. 31, 2016 | $ 269,589 | $ 719 | $ 256,529 | $ (302) | $ (21) | $ 12,664 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Cash flows from operating activities: | |||
Net income | $ 7,590 | $ 58,053 | $ 36,054 |
Adjustments to reconcile net income to net cash provided by operating activities: | |||
Depreciation and amortization | 6,249 | 5,291 | 2,500 |
Stock-based compensation | 21,589 | 21,882 | 15,289 |
Deferred income tax benefit | (5,636) | (4,914) | (655) |
Loss on disposal of assets | 41 | ||
Excess tax benefits on stock options and awards | 1,729 | (13,596) | (21,449) |
Amortization of investment discount | 2,029 | 1,431 | 367 |
Changes in operating assets and liabilities: | |||
Accounts receivable | 26,618 | (23,770) | (7,796) |
Inventories | 15,044 | (3,616) | (23,571) |
Prepaid expenses and other current assets | (1,721) | 1,345 | (2,967) |
Accounts payable, accrued expenses and other current liabilities | (18,487) | 50,708 | 52,813 |
Accrued litigation award and settlements | 3,900 | 9,423 | |
Net cash provided by operating activities | 58,904 | 102,278 | 50,585 |
Cash flows from investing activities: | |||
Change in restricted cash | 400 | ||
Purchase of investments | (115,375) | (138,470) | (56,605) |
Proceeds from sales of investments | 7,948 | 25,492 | |
Proceeds from maturities of investments | 96,009 | 36,643 | 8,195 |
Purchases of property and equipment | (10,614) | (13,842) | (22,245) |
Net cash used in investing activities | (22,032) | (90,177) | (70,255) |
Cash flows from financing activities: | |||
Proceeds from issuance of common stock | 2,280 | 2,647 | 1,989 |
Excess tax benefits on stock options and awards | (1,729) | 13,596 | 21,449 |
Proceeds from exercise of stock options | 3,803 | 9,524 | 8,956 |
Repurchase of common stock | (16,099) | (16,459) | |
Net cash provided by (used in) financing activities | (11,745) | 9,308 | 32,394 |
Change in cash and cash equivalents | 25,127 | 21,409 | 12,724 |
Cash and cash equivalents, beginning of period | 79,515 | 58,106 | 45,382 |
Cash and cash equivalents, end of period | 104,642 | 79,515 | 58,106 |
Supplemental cash flow disclosures: | |||
Cash paid for income taxes | 10,742 | $ 15,351 | $ 2,975 |
Non-cash capital expenditures | $ 425 |
Note 1 - Nature of Business
Note 1 - Nature of Business | 12 Months Ended |
Dec. 31, 2016 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Nature of Business | 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 commercial-stage specialty pharmaceutical company that develops and commercializes innovative supportive care products. We have one commercially marketed product: SUBSYS®, a proprietary sublingual fentanyl spray for BTCP in opioid-tolerant adult patients; and one product: SYNDROS™, awaiting final labeling approval by the FDA, prior to commercial launch, after receiving FDA approval in July 2016 and DEA scheduling in March 2017. |
Note 2 - Significant Accounting
Note 2 - Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2016 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | 2. Significant Accounting Policies Revision of Previously Issued Financial Statements for Correction of Immaterial Errors During the three months ended September 30, 2016, we identified an error related to the accounting for the rebates component of our product sales allowances since 2014.. We determined that we had incorrectly applied the accounting guidance in Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) No. 605, “Revenue Recognition” by miscalculating our rebate obligations on government payer and managed care contracts. In addition, we recorded out-of-period adjustments that resulted in an increase in operating expenses of $1,500,000 related to stock option modifications during the three months ended March 31, 2016 and a decrease in income tax expense of $834,000 related to the deductible interest expense portion of the accrued litigation award and settlements recorded during 2016. We assessed the materiality of these errors on our prior annual financial statements, assessing materiality both quantitatively and qualitatively, in accordance with the SEC’s Staff Accounting Bulletin (“SAB”) No. 99 and SAB No. 108 and concluded that the errors were not material to our consolidated financial statements for the years ended December 31, 2015 and 2014. However, to correctly present net revenue, operating expenses and income tax expense in the appropriate periods, management revised its previously issued financial statements for the years ended December 31, 2015 and 2014. Certain amounts in prior periods as previously reported have been reclassified to conform to the current period presentation. The following tables summarize the impact and financial statement line items impacted by the revision adjustments as of and for the years ended December 31, 2015 and 2014 : As of December 31, 2015 (in thousands) Consolidated Balance Sheet: As previously reported Adjustments As revised Deferred income tax assets, net 16,331 1,276 17,607 Total assets 350,009 1,276 351,285 Accounts payable and accrued expenses 36,354 (743 ) 35,611 Accrued sales allowances 31,526 3,507 35,033 Total current liabilities 87,672 2,764 90,436 Uncertain income tax position 8,635 (91 ) 8,544 Total liabilities 96,307 2,673 98,980 Additional paid in capital 245,736 949 246,685 Retained earnings 7,420 (2,346 ) 5,074 Total stockholders' equity 253,702 (1,397 ) 252,305 Total liabilities and stockholders' equity $ 350,009 $ 1,276 $ 351,285 Year Ended December 31, 2015 (in thousands, except per share data) Consolidated Statement of Comprehensive Income: As previously reported Adjustments As revised Net revenue $ 330,797 $ (474 ) $ 330,323 Gross profit 301,943 (474 ) 301,469 Operating expenses: Research and development 55,281 1,500 56,781 Total operating expenses 209,513 1,500 211,013 Operating income 92,430 (1,974 ) 90,456 Income before income taxes 92,968 (1,974 ) 90,994 Less: income tax expense 34,492 (1,551 ) 32,941 Net income 58,476 (423 ) 58,053 Total comprehensive income $ 58,348 $ (423 ) $ 57,925 Net income per common share: Basic $ 0.82 $ (0.01 ) $ 0.81 Diluted $ 0.77 $ (0.00 ) $ 0.77 Year Ended December 31, 2015 (in thousands) Consolidated Statement of Cash Flows: As previously reported Adjustments As revised Cash flows from operating activities: Stock-based compensation $ 20,382 $ 1,500 $ 21,882 Deferred income tax benefit (4,118 ) (796 ) (4,914 ) Excess tax benefits on stock options and awards (13,593 ) (3 ) (13,596 ) Prepaid expenses and other current assets 1,311 34 1,345 Accounts payable, accrued expenses and other current liabilities 51,023 (315 ) 50,708 Net cash provided by operating activities 102,281 (3 ) 102,278 Cash flows from financing activities: Excess tax benefits on stock options and awards 13,593 3 13,596 Net cash provided by financing activities $ 9,305 $ 3 $ 9,308 As of December 31, 2014 (in thousands) Consolidated Statement of Stockholders' Equity: As previously reported Adjustments As revised Additional paid in capital 216,061 (554 ) 215,507 Retained earnings (51,056 ) (1,923 ) (52,979 ) Total stockholders' equity 165,667 (2,477 ) 163,190 Total liabilities and stockholders' equity $ 215,121 $ 514 $ 215,635 Year Ended December 31, 2014 (in thousands) Consolidated Statement of Comprehensive Income: As previously reported Adjustments As revised Net revenue $ 222,125 $ (3,033 ) $ 219,092 Gross profit 199,547 (3,033 ) 196,514 Operating income 64,023 (3,033 ) 60,990 Income before income taxes 64,176 (3,033 ) 61,143 Less: income tax expense 26,199 (1,110 ) 25,089 Net income 37,977 (1,923 ) 36,054 Total comprehensive income $ 37,953 $ (1,923 ) $ 36,030 Net income per common share: Basic $ 0.55 $ (0.03 ) $ 0.52 Diluted $ 0.52 $ (0.03 ) $ 0.49 Year Ended December 31, 2014 (in thousands) Consolidated Statement of Cash Flows: As previously reported Adjustments As revised Cash flows from operating activities: Deferred income tax benefit (175 ) (480 ) (655 ) Excess tax benefits on stock options and awards (22,003 ) 554 (21,449 ) Prepaid expenses and other current assets (2,933 ) (34 ) (2,967 ) Accounts payable, accrued expenses and other current liabilities 50,376 2,437 52,813 Net cash provided by operating activities 50,031 554 50,585 Cash flows from financing activities: Excess tax benefits on stock options and awards 22,003 (554 ) 21,449 Net cash provided by financing activities $ 32,948 $ (554 ) $ 32,394 Principles of Consolidation The consolidated financial statements include the accounts of Insys Therapeutics, Inc. and its wholly-owned subsidiaries. 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. FASB ASC No. 820, “Fair Value Measurement” defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. It also establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows: Level 1: Observable inputs such as quoted prices in active markets; Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions. Revenue Recognition We recognize revenue from the sale of SUBSYS®. Revenue is recognized when (i) persuasive evidence of an arrangement exists, (ii) delivery has occurred and title has passed, (iii) the price is fixed or determinable and (iv) collectability is reasonably assured. SUBSYS® 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 to wholesale pharmaceutical distributors and directly to specialty retail pharmacies (collectively, our customers) subject to rights of return within a period beginning six months prior to, and ending 12 months following, product expiration. SUBSYS® currently has a shelf life of 36 months from the date of manufacture. We record revenue for SUBSYS® at the time the customer receives the shipment. We recognize estimated product sales allowances as a reduction of product sales in the same period the related revenue is recognized. Product sales allowances are based on amounts owed or to be claimed on the related sales. These estimates take into consideration the terms of our agreements with customers and third-party payers and the levels of inventory within the distribution channels that may result in future discounts taken. In certain cases, such as patient assistance programs, we recognize the cost of patient discounts as a reduction of revenue based on estimated utilization. If actual future results vary, we may need to adjust these estimates, which could have an effect on product revenue in the period of adjustment. Our product sales allowances include: Product Returns. We allow customers to return product for credit within six months before and up to 12 months following its product expiration date. The shelf life of SUBSYS® is currently 36 months from the date of manufacture. We have monitored actual return history since product launch, which provides us with a basis to reasonably estimate future product returns, taking into consideration the shelf life of product at the time of shipment, shipment and prescription trends, estimated distribution channel inventory levels, and consideration of the introduction of competitive products. Because of the shelf life of our products and our return policy of issuing credits on returned product that is within six months before and up to 12 months after 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. We offer discounts to certain wholesale distributors based on contractually determined rates. We accrue the discount as a reduction of receivables due from the wholesalers upon shipment to the respective wholesale distributors and retail pharmacies. Prompt Pay Discounts. We offer cash discounts to our customers, generally 2.0% of the sales price, as an incentive for prompt payment. We account for cash discounts by reducing accounts receivable by the full amount of the discount. Stocking Allowances. We may offer discounts and extended payment terms, generally in the month of the initial commercial launch of a new product and on the first order made by certain wholesale distributors and retail pharmacies based on contractually determined rates. We accrue the discount as a reduction of receivables due from the wholesalers upon shipment to the respective wholesale distributors and retail pharmacies. Patient Discount Programs . We offer discount card programs to patients for SUBSYS® in which patients receive discounts on their prescriptions that are reimbursed by us to the retailer. We estimate the total amount that will be redeemed based on a percentage of actual redemption applied to inventory in the distribution and retail channels. The allowance for patient discount programs is included in accrued sales allowances. Rebates. We participate in certain rebate programs, which provide discounted prescriptions to qualified insured patients. Under these rebate programs, we pay a rebate to the third-party administrator of the program, generally two to three months after the quarter in which prescriptions subject to the rebate are filled. We estimate and accrue these rebates based on current contract prices, historical and estimated future percentages of products sold to qualified patients and estimated levels of inventory in the distribution channel. The allowance for rebates is included in accrued sales allowances. Chargebacks. We provide discounts primarily to authorized users of the FSS of the General Services Administration under an FSS contract negotiated by the Department of Veterans Affairs and various organizations under Medicaid contracts and regulations. These entities purchase products from the wholesale distributors at a discounted price, and the wholesale distributors then charge back to us the difference between the current retail price and the price the entity paid for the product. We estimate and accrue chargebacks based on estimated wholesaler inventory levels, current contract prices and historical chargeback activity. The allowance for chargebacks is included as a reduction to accounts receivable. Dronabinol SG Capsule Our Dronabinol SG Capsule product was commercially launched in December 2011, and we sold Dronabinol SG Capsule exclusively to Mylan in the United States under a 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 and commercial paper are carried at cost which approximates fair value. We classify our marketable securities as available-for-sale in accordance with FASB ASC Topic 320, Investments — Debt and Equity Securities. 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. In the ordinary course of business, and consistent with industry practices, we may from time to time offer extended payment terms to our customers as an incentive for new product launches or in other circumstances. These extended payment terms do not represent a significant risk to the collectability of accounts receivable as of the period-end and are evaluated in accordance with ASC 605 —Revenue Recognition 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 losses (“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 operating results. 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 consolidated statements of comprehensive income. 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 $1,572,000, $1,166,000 and $800,000 for the years ended December 31, 2016, 2015 and 2014, 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 $22,840,000, $19,448,000 and $16,926,000 for the years ended December 31, 2016, 2015 and 2014, 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, which is generally three to four years, on a straight-line basis. 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 accounting principles generally accepted in the United States of America (“U.S. 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 October 2016, the FASB issued ASU No. 2016-16, Income Taxes (Topic 740): Intra-Entity Transfers of Assets Other Than Inventory, to improve the accounting for the income tax consequences of intra-entity transfers of assets other than inventory. Current U. S. GAAP prohibits the recognition of current and deferred income taxes for an intra-entity asset transfer until the asset has been sold to an outside party, which is an exception to the principle of comprehensive recognition of current and deferred income taxes in U. S. GAAP. The amendments in this update eliminate the exception for an intra-entity transfer of an asset other than inventory. The amendments should be applied on a modified retrospective transition basis, and are effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years, and early adoption is permitted. We are currently evaluating the impact of these amendments on our consolidated financial statements. In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments. The amendments affect entities required to present a statement of cash flows and provides specific guidance on a variety of cash flow issues to reduce current and potential future diversity in practice. The amendments are effective for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years, and early adoption is permitted. An entity that elects early adoption must adopt all of the amendments in the same period. The amendments should be applied using a retrospective transition method to each period presented. We are currently evaluating the impact of these amendments on our consolidated financial statements. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. The amendments affect entities holding financial assets and net investment in leases that are not accounted for at fair value through net income, and are effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years, and early adoption is permitted. ASU 2016-13 amends the impairment model to utilize an expected loss methodology in place of the currently used incurred loss methodology, which will result in the timelier recognition of losses. We are currently evaluating the impact of these amendments on our consolidated financial statements. In March 2016, the FASB issued ASU No. 2016-09, Compensation-Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting, to reduce complexity in accounting standards involving several aspects of the accounting for employee share-based payment transactions, including (1) the income tax consequences, (2) classification of awards as either equity or liabilities, and (3) classification in the statement of cash flows. The amendments will be effective for financial statements issued for fiscal years beginning after December 15, 2016, including interim periods within those fiscal years. Amendments related to the timing of when excess tax benefits are recognized, minimum statutory withholding requirements, forfeitures, and intrinsic value should be applied using a modified retrospective transition, amendments related to the presentation of employee taxes paid on the statement of cash flows when an employer withholds shares to meet the minimum statutory withholding requirement should be applied retrospectively, amendments requiring recognition of excess tax benefits and tax deficiencies in the income statement and the practical expedient for estimating expected term should be applied prospectively, and amendments related to the presentation of excess tax benefits on the statement of cash flows can be applied using either a prospective transition method or a retrospective transition method. We will adopt the new guidance in the first quarter of 2017. Under the new guidance, excess tax benefits related to equity compensation will be recognized in the provision for income taxes in the consolidated statements of comprehensive income rather than in additional paid-in capital in the consolidated balance sheets and will be applied on a prospective basis. We have not yet determined our selected method of transition for changes to the statements of cash flows related to the classification of excess tax benefits and employee taxes paid for share-based payment arrangements. The related financial statement impacts of adopting the above aspects of this ASU are not expected to be material. However, depending on several factors such as the market price of our common stock, employee exercise behavior and corporate income tax rates, the excess tax benefits associated with the exercise of stock options could generate a significant discrete income tax benefit in a particular interim period potentially creating volatility in net income and net income per share period-to-period and period-over-period. In February 2016, the FASB issued ASU No. 2016-02, Leases: (Topic 842), to provide guidance on recognizing lease assets and lease liabilities on the balance sheet and disclosing key information about leasing arrangements, specifically differentiating between different types of leases. The core principle of Topic 842 is that a lessee should recognize the assets and liabilities that arise from all leases. The recognition, measurement, and presentation of expenses and cash flows arising from a lease by a lessee have not significantly changed from previous U.S. GAAP guidance. There continues to be a differentiation between finance leases and operating leases. However, the principal difference from previous guidance is that the lease assets and lease liabilities arising from operating leases should be recognized in the balance sheet. The accounting applied by a lessor is largely unchanged from that applied under previous U.S. GAAP guidance. The amendments will be effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years, and early adoption is permitted. In transition, lessees and lessors are required to recognize and measure leases at the beginning of the earliest period presented using a modified retrospective approach. The modified retrospective approach includes a number of optional practical expedients that entities may elect to apply. These practical expedients relate to the identification and classification of leases that commenced before the effective date, initial direct costs for leases that commenced before the effective date, and the ability to use hindsight in evaluating lessee options to extend or terminate a lease or to purchase the underlying asset. An entity that elects to apply the practical expedients will, in effect, continue to account for leases that commence before the effective date in accordance with previous U.S. GAAP guidance unless the lease is modified, except that lessees are required to recognize a right-of-use asset and a lease liability for all operating leases at each reporting date based on the present value of the remaining minimum rental payments that were tracked and disclosed under previous U.S. GAAP guidance. We are currently evaluating the impact of these amendments on our consolidated financial statements and related disclosures; however, based on our current operating leases, we do not expect that the adoption of this guidance will have a material impact on the consolidated financial statements. See Note 7, Commitments and Contingencies, In January 2016, the FASB issued ASU No. 2016-01, Financial Instruments—Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities, which amended the Financial Instruments topic of the ASC to address certain aspects of recognition, measurement, presentation, and disclosure of financial instruments. The amendments will be effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years, and early adoption is not permitted. These amendments should be applied by means of a cumulative-effect adjustment to the balance sheet as of the beginning of the fiscal year of adoption. The amendments related to equity securities without readily determinable fair values (including disclosure requirements) should be applied prospectively to equity investments that exist as of the date of adoption. We are currently evaluating the impact of these amendments on our consolidated financial statements. In July 2015, the FASB issued ASU No. 2015-11, Inventory (Topic 330): Simplifying the Measurement of Inventory. The guidance requires entities to measure most inventory at the lower of cost and NRV, thereby simplifying the current guidance under which an entity must measure inventory at the lower of cost or market. Under the new guidance, inventory is measured at the lower of cost and NRV, which eliminates the need to determine replacement cost and evaluate whether it is above the ceiling (NRV) or below the floor (NRV less a normal profit margin). The guidance defines NRV as the “estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation.” The guidance is effective for annual periods beginning after December 15, 2016, and interim periods therein. We will adopt the new guidance in the first quarter of 2017. We do not believe that the adoption of this guidance will have a material impact on our consolidated financial statements. In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606). The new standard aims to achieve a consistent application of revenue recognition within the United States, resulting in a single revenue model to be applied by reporting companies under U.S. GAAP. Under the new model, recognition of revenue occurs when a customer obtains control of promised goods or services in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. In addition, the new standard requires that reporting companies disclose the nature, amount |
Note 3 - Short-term and Long-te
Note 3 - Short-term and Long-term Investments | 12 Months Ended |
Dec. 31, 2016 | |
Schedule Of Investments [Abstract] | |
Short-Term and Long-Term Investments | 3. Short-Term and Long-Term Investments Investments consisted of the following at December 31, 2016 (in thousands): December 31, 2016 Cost Unrealized Gains Unrealized Losses Other- Than- Temporary Impairment Losses Fair Value Cash and Cash Equivalents Short-term Investments Long-term Investments Cash $ 49,331 $ — $ — $ — $ 49,331 $ 49,331 $ — $ — Money market securities 54,015 — — — 54,015 54,015 — — Marketable securities: Certificates of deposit 26,114 — — — 26,114 — 13,855 12,259 Commercial paper 1,485 — — — 1,485 — 1,485 — Corporate securities 39,562 — (135 ) — 39,427 500 25,681 13,246 Federal agency securities 30,660 4 (92 ) — 30,572 — 10,854 19,718 Municipal securities 35,811 2 (81 ) — 35,732 796 26,363 8,573 Total marketable securities 133,632 6 (308 ) — 133,330 1,296 78,238 53,796 $ 236,978 $ 6 $ (308 ) $ — $ 236,676 $ 104,642 $ 78,238 $ 53,796 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 — — Marketable securities: Certificates of deposit 26,223 — — — 26,223 — 16,637 9,586 Commercial paper 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 126,102 16 (168 ) — 125,950 3,155 79,576 43,219 $ 202,462 $ 16 $ (168 ) $ — $ 202,310 $ 79,515 $ 79,576 $ 43,219 The amortized cost and estimated fair value of the marketable securities, by maturity, are shown below (in thousands): December 31, 2016 December 31, 2015 Amortized Cost Fair Value Amortized Cost Fair Value Marketable securities: Due in one year or less $ 80,092 $ 80,027 $ 82,785 $ 82,731 Due after one year through 5 years 53,540 53,303 43,317 43,219 Due after 5 years through 10 years — — — — Due after 10 years — — — — $ 133,632 $ 133,330 $ 126,102 $ 125,950 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, 2016 December 31, 2015 Less Than 12 Months Greater Than 12 Months Less Than 12 Months Greater Than 12 Months Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss Marketable securities: Corporate securities $ 38,027 $ (134 ) $ 401 $ (1 ) $ 25,137 $ (68 ) $ — $ — Federal agency securities 26,449 (91 ) 1,217 (1 ) 18,759 (65 ) — — Municipal securities 30,373 (81 ) 100 — 22,981 (35 ) — — $ 94,849 $ (306 ) $ 1,718 $ (2 ) $ 66,877 $ (168 ) $ — $ — As of December 31, 2016 and 2015, 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, 2016 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurement | 4. Fair Value Measurement At December 31, 2016 and 2015, 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, 2016 and 2015, have been valued based on Level 2 inputs. Available-for-sale securities classified within Level 2 of the fair value hierarchy are valued utilizing reports from an independent third-party public quotation service based on closing prices on the last business day of the period presented. In addition, we use the public quotation service to perform price testing by comparing quoted prices listed in reports provided by the asset managers that hold our investments to quotes listed through the public quotation service. These asset managers utilize an independent pricing source to obtain quotes for most fixed income securities, and utilize internal procedures to validate the prices obtained. Our Level 3 asset represents our investment in a long-term corporate convertible promissory note and a warrant to purchase shares issued in connection with the convertible promissory note, which converted to convertible preferred stock as of December 31, 2016. This stock is not listed on any security exchange. The fair value of the preferred stock approximates its carrying value at December 31, 2016. Our investments measured at fair value on a recurring basis subject to the disclosure requirements of ASC 820 at December 31, 2016 were as follows (in thousands): Fair Value Measurement at Reporting Date Total Quoted Prices in active Markets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Marketable securities: Certificates of deposit $ 26,114 $ — $ 26,114 $ — Commercial paper 1,485 — 1,485 — Corporate securities 39,427 — 38,927 500 Federal agency securities 30,572 — 30,572 — Municipal securities 35,732 — 35,732 — Total assets measured at fair value $ 133,330 $ — $ 132,830 $ 500 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: Certificates of deposit $ 26,223 $ — $ 26,223 $ — Commercial paper — — — — 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 $ 125,950 $ — $ 125,950 $ — The following table presents additional information about assets measured at fair value on a recurring basis and for which we utilize Level 3 inputs to determine fair value for the years ended December 31, 2016 and 2015 (in thousands): December 31, 2016 2015 Convertible stock Balance, beginning of period $ — $ — Change in fair value — — Purchases 500 — Balance, end of period $ 500 $ — |
Note 5 - Inventories
Note 5 - Inventories | 12 Months Ended |
Dec. 31, 2016 | |
Inventory Disclosure [Abstract] | |
Inventories | 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, 2016 December 31, 2015 Finished goods $ 8,408 $ 28,216 Work-in-process 6,183 7,018 Raw materials and supplies 7,152 6,481 Total inventories 21,743 41,715 Plus: non-current finished goods 4,928 — $ 26,671 $ 41,715 As of December 31, 2016 and 2015, raw materials inventories consisted of raw materials used in the manufacture of the API in our U.S.-based, state-of-the-art dronabinol manufacturing facility and component parts and packaging materials used in the manufacture of SUBSYS®. Work-in-process consists of actual production costs, including facility overhead and tolling costs of in-process dronabinol and SUBSYS® products. Finished goods inventories consisted of finished SUBSYS® products. Non-current finished goods represent those inventories not expected to be sold within 12 months of the balance sheet date and are included in other assets in our consolidated balance sheets. As of December 31, 2016, all work-in-process inventory is expected to be used within 12 months of the balance sheet date and, therefore, is classified as current inventory. We maintain an allowance for excess and obsolete inventory, as well as inventory where its cost is in excess of its net realizable value. Inventory at December 31, 2016 and 2015 were reported net of these reserves of $6,793,000 and $100,000, respectively. |
Note 6 - Property and Equipment
Note 6 - Property and Equipment | 12 Months Ended |
Dec. 31, 2016 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment | 6. Property and Equipment Property and equipment are comprised of the following (in thousands): Estimated Useful Life As of December 31, (in years) 2016 2015 Computer equipment 3 — 7 $ 3,462 $ 2,798 Scientific equipment 3 — 10 12,930 9,283 Furniture 3 — 10 3,128 2,022 Manufacturing equipment 7 — 10 20,583 19,536 Leasehold improvements * 23,243 16,771 Less: accumulated depreciation and amortization (20,174 ) (12,028 ) Total fixed assets $ 43,172 $ 38,382 * 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, 2016, 2015 and 2014 was $6,249,000, $5,291,000 and $2,500,000, respectively. As of December 31, 2016 and 2015, respectively, there was $6,857,000 and $7,391,000 of construction in progress included in total fixed assets that had not been placed into service and was not subject to depreciation. |
Note 7 - Commitments and Contin
Note 7 - Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2016 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 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, 2016, with a remaining non-cancelable lease term in excess of one year, are as follows (in thousands): Years ending December 31, 2017 $ 3,113 2018 3,310 2019 3,405 2020 3,495 2021 2,526 Thereafter 14,429 Total $ 30,278 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. Landlord incentives are recorded as deferred rent and amortized on a straight-line basis over the lease term. Deferred rent was approximately $3,003,000 as of December 31, 2016 and $3,160,000 as of December 31, 2015. Rent expense under operating leases for the years ended December 31, 2016, 2015 and 2014 was approximately $2,757,000, $2,445,000, and $1,698,000, respectively. Letters of Credit As of December 31, 2016, we had a $400,000 unused letter of credit related to the requirements of our facility lease agreement. Material Agreements In April 2015, we entered into an amendment to our manufacturing and supply agreement with DPT, which extends our existing manufacturing and supply agreement to produce SUBSYS® until the end of 2020. In addition to extending the term, this amendment added certain minimum purchase commitments. In October 2015, we entered into an amended and restated supply, development & exclusive licensing agreement with Aptargroup, Inc. (“Aptar”) which, among other things, extended our exclusive supply rights to the current sublingual device, currently utilized by SUBSYS®, as well any new device(s) jointly developed by the two companies for a period of seven years. In addition to extending the term, this amendment added certain minimum purchase commitments and requires certain tiered royalties as a percentage of net revenue to be paid by us ranging from less than one percent to the low single digits, commencing in March 2016 through the term of this agreement, from our sales of SUBSYS® and future products that use the Aptar spray device technology. As of December 31, 2016, our remaining estimated annual contractual obligation under our agreement with Aptar was $20,290,000. In January 2016, we assigned our rights, title, duties and obligations of our manufacturing and supply agreement with DPT and our supply, development & exclusive licensing agreement with Aptar from our parent to our manufacturing subsidiary as part of a corporate restructuring. In July 2016, we, through our manufacturing subsidiary, entered into a further amendment to our DPT manufacturing and supply agreement dated May 24, 2011, as amended. This amendment effectively eliminates any prior minimum purchase (and batch) obligations that had been set forth in the amendment dated April 30, 2015 and replaces it with a new annual purchase commitment of $4,000,000 per calendar year commencing January 1, 2017 through December 31, 2020. As a result, the cumulative effect related to this amendment reduces our aggregated minimum purchase commitments with DPT from $49,740,000 to $16,000,000 through December 31, 2020. As of December 31, 2016, our remaining estimated annual contractual obligation under our agreement with DPT was $16,000,000. All purchase commitments required under our agreements with DPT and Aptar were met during the years ended December 31, 2016 and 2015. The following table sets forth our aggregate minimum purchase commitments with DPT and Aptar under these agreements (in thousands): Years ending December 31, 2017 $ 7,500 2018 7,500 2019 8,410 2020 8,550 2021 4,330 Thereafter — Total $ 36,290 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. During the years ended December 31, 2016 and 2015, matching contribution plan expenses totaled approximately $730,000 and $670,000, respectively. Matching contributions for the year ended December 31, 2014 were nominal Legal Matters Other than the matters that we have disclosed below, we from time to time become involved in various ordinary course legal and administrative proceedings, which include intellectual property, commercial, governmental and regulatory investigations, employee related issues and private litigation, which we do not currently believe are either individually or collectively material. We record accruals for contingencies when it is probable that a liability has been incurred and the amount can be reasonably estimated. These accruals are adjusted periodically as assessments change or additional information becomes available. If the reasonable estimate of a probable loss is a range, and no amount within the range is a better estimate, the minimum amount in the range is accrued. If a loss is not probable or a probable loss cannot be reasonably estimated, no liability is recorded. We have established reserves for certain of our legal matters. Our loss estimates are generally developed in consultation with outside counsel and are based on analyses of potential outcomes. As legal and governmental proceedings, disputes and investigations are inherently unpredictable and, in part, beyond our control, unless otherwise indicated, we cannot reasonably predict the outcome of these legal proceedings, nor can we estimate the amount of loss, or range of loss, if any, that may result from these proceedings. While our liability in connection with certain claims cannot be currently estimated, the resolution in any reporting period of one or more of these matters could have a significant impact on our financial condition, results of operations and cash flows for that future period and could ultimately have a material adverse effect on our consolidated financial position and could cause the market value of our common shares to decline. While we believe we have valid defenses in these matters, litigation and governmental and regulatory investigations are inherently uncertain and we may in the future incur material judgments or enter into material settlements of claims. Government Proceedings Like other companies in the pharmaceutical industry, we are subject to extensive regulation by national, state and local government agencies in the United States. As a result, interaction with government agencies occurs in the normal course of our operations. The following is a brief description of pending governmental investigations 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, as well as a corporate integrity agreement or similar government mandated compliance document that institutes significant restrictions or obligations, could result for us from any government investigation or proceeding. In addition, even certain investigations that are not discussed below and which we do not deem to be material at this time could be determined to be material and could have a material adverse effect on our financial condition, results of operations and cash flows. Department of Health and Human Services Investigation . We received a subpoena, dated December 9, 2013, from the Office of Inspector General of the HHS in connection with an investigation of potential violations involving HHS programs. This subpoena was issued in connection with an investigation by the U.S. Attorney’s Office for the Central District of California. This subpoena requests documents regarding our business, including the commercialization of SUBSYS®. We are cooperating with this investigation and have produced documents in response to the subpoena and have provided other requested information. We believe a loss is probable with respect to this investigation, but we are not in a position to estimate a range of such loss or other scope and outcome associated with this investigation. HIPAA Investigation . On September 8, 2014, we received a subpoena issued pursuant to HIPAA from the U.S. Attorney’s Office for the District of Massachusetts. The subpoena requests documents regarding SUBSYS®, including our sales and marketing practices related to this product. This investigation also relates to activities in our patient services hub. We are cooperating with this investigation and have produced documents in response to the subpoena and have provided other requested information. We believe a loss is probable with respect to this investigation, but we are not in a position to estimate a range of such loss or other scope and outcome associated with this investigation. On or about June 23, 2015, a nurse practitioner located in Connecticut, who served on our speaker bureau in connection with our speaker programs designed to educate and promote product awareness and safety for external health care providers, pled guilty to violating the federal Anti-Kickback Statute in connection with payments of approximately $83,000 from us. Several of our former employees have been charged in criminal proceedings. On or about February 18, 2016, one of our former sales employees located in Alabama pled guilty to a conspiracy to violate the federal Anti-Kickback Statute in regards to two Alabama health care professionals who prescribed our product SUBSYS®. These two Alabama health care professionals, who served on our speaker bureau in connection with our speaker programs designed to educate and promote product awareness and safety for external health care providers, were charged by the U.S. Attorney’s Office for the Southern District of Alabama, and on or about February 23, 2017, were convicted on 19 of 20 counts brought against them which included charges related to distribution of a controlled substance, drug conspiracy, healthcare fraud conspiracy and money laundering. Moreover, on or about June 19, 2016, a former district sales manager in New York and a former sales representative in New Jersey were charged in a federal court in Manhattan, New York with violating the federal Anti-Kickback Statute in connection with interacting with health care professionals who prescribed our product and served on our speaker bureau. Both of these employees have pled not guilty. On or about October 13, 2016, a former prior authorization specialist and manager of our patient services hub was charged by the U.S. Attorney’s Office for the District of Massachusetts with conspiracy to commit wire fraud in connection with the Company’s provision of prior authorization support related to our patient services hub. On or about December 8, 2016, the U.S. Attorney’s Office for the District of Massachusetts issued an indictment against six former employees, including Michael L. Babich, our former President, CEO and director, on charges including racketeering conspiracy, conspiracy to commit mail fraud, conspiracy to commit wire fraud, conspiracy to violate the Anti-Kickback Statute and forfeiture. Other than the former Alabama sales employee, each of these indicted individuals have entered pleas of not guilty to the charges against them. It is possible that additional individual criminal charges and convictions and pleas could result from our ongoing federal and state government investigations and related proceedings. We continue to assess these matters to ensure we have an effective compliance program. State Related Investigations . We have received Civil Investigative Demands (“CIDs”) or subpoenas, as the case may be, from each of the Office of the Attorney General (or similarly named and authorized office) of the State of Arizona, Colorado, Florida, Illinois, Massachusetts, Maryland, Minnesota, New Hampshire, New Jersey, New York, Oregon, Pennsylvania and Washington. Moreover, we have received an administrative subpoena from the California Insurance Commissioner. In addition, we understand that numerous physicians practicing within several of the aforementioned states have received subpoenas from each applicable state Attorney General or Department of Justice office in connection with interactions with us. Generally, these CIDs and subpoenas request documents regarding SUBSYS®, including our sales and marketing practices related to SUBSYS® in the applicable state, as well as our patient services hub. We are cooperating with each of these investigations and have produced documents in response to these CIDs, subpoenas and related requests for information from each office. In connection with the investigation by the Oregon Department of Justice (“ODOJ”) we entered into a settlement agreement with the ODOJ referred to as an Assurance of Voluntary Compliance (“AVC”), and made monetary payments totaling approximately $1,100,000. The AVC requires us to maintain certain controls and processes around our promotional and sales activity related to SUBSYS® in Oregon. This AVC expressly provides that we do not admit any violation of law or regulation. This settlement was reached as result of our cooperation with the ODOJ's investigation and after producing documents in response to certain CIDs and related requests for information from the ODOJ. All monetary payments in connection with this settlement were made prior to December 31, 2015. In connection with the investigation by the State of Illinois, on August 25, 2016, the Illinois Office of the Attorney General filed a complaint on behalf of the State of Illinois against the Company in the Circuit Court of Cook County, Illinois, Chancery Division. The complaint asserts a claim for violation of the Illinois Consumer Fraud and Deceptive Business Practices Act in connection with the sales and marketing of SUBSYS® in Illinois. The complaint seeks injunctive relief, including a permanent injunction preventing us from engaging in commerce in the State of Illinois and civil penalties. The Circuit Court of Cook County extended the time for us to answer or otherwise respond to the complaint and the next status hearing is April 7, 2017. We continue to cooperate with this investigation and to engage in discussion with the Illinois Office of the Attorney General. In connection with the investigation by the State of New Hampshire, we entered into a settlement agreement with the State of New Hampshire referred to as an assurance of discontinuance, and made monetary payments totaling approximately $2,900,000 to the State of New Hampshire and a charitable contribution of $500,000 to be used by a New Hampshire charitable foundation in preventing or remediating problems related to abuse, misuse or misprescribing of opioid drugs. The assurance of discontinuance expressly provides that we do not admit any violation of law or regulation and requires us to maintain certain controls and processes around our promotional and sales activity related to SUBSYS® in New Hampshire. This settlement was reached as result of our cooperation with the State of New Hampshire investigation and after producing documents in response to certain requests for information by the State of New Hampshire. These amounts have been accrued in the consolidated balance sheet as of December 31, 2016 and the payments in connection with this settlement were made after December 31, 2016. In connection with the investigation by the State of Massachusetts, we have made a reasonable estimate of a probable loss of approximately $500,000. We continue to cooperate with the State of Massachusetts investigation, including producing documents in response to certain requests for information. This estimated amount has been accrued in the consolidated balance sheet as of December 31, 2016. Investigations of Physicians . In addition to the above investigations that are specifically directed at our company, we have received governmental agency requests for information, including subpoenas, from the USAO of Connecticut, Eastern District of Michigan, Florida (Jacksonville), Kansas, New Hampshire, Rhode Island, Southern District of New York, Southern District of Alabama and Western District of New York regarding specific physicians that we have interacted with in those states. Opioid Litigation . Many federal and governmental agencies are focused on the abuse of opioids in the United States and agencies such as the HHS have expressed their belief that the United States is in the midst of a prescription opioid abuse epidemic. Common prescription drugs that contain opioids are drugs such as oxycodone, hydrocodone and fentanyl. Our product, SUBSYS®, is a fentanyl-based product in the TIRF class. Certain stakeholders in the healthcare community, regulatory bodies and governmental agencies may associate us with, or determine that we are a part of, this perceived opioid abuse epidemic. Like all TIRF products, our product is part of the mandatory TIRF REMS program which is designed “to ensure informed risk-benefit decisions before initiating treatment, and while patients are treated to ensure appropriate use of TIRF medicines” and “to mitigate the risk of misuse, abuse, addiction, overdose and serious complications due to medication errors with the use of TIRF medicines.” Nevertheless, from time to time, we may be included in litigation or investigations that are directed at the abuse of opioids in the United States. For example, in May 2014, Santa Clara and Orange Counties in California filed a complaint in state court in Orange County, California against numerous pharmaceutical manufacturers alleging claims related to opioid marketing practices, including false advertising, unfair competition, and public nuisance. Despite the fact that we are not named specifically in the complaint and this lawsuit was recently stayed, we have received a preservation notice letter from the Office of the County Counsel for the County of Santa Clara. From time to time, we may be included in these types of litigations as a result of the fact that we market an opioid product. In addition, on March 28, 2017, the Ranking Member of the With the exception of the investigations by the ODOJ, the State of New Hampshire and the State of Massachusetts which we have quantified above, and the investigations by the Department of Health and Human Services and HIPAA for which we have responded to subpoenas as requested, we believe a loss from an unfavorable outcome of these governmental proceedings is reasonably possible and an estimate of the amount or range of loss from an unfavorable outcome is not determinable at these stages. We believe we have meritorious legal positions and will continue to represent our interests vigorously in these matters. However, responding to government investigations has and could continue to burden us with substantial legal costs in connection with defending any claims raised. Any potential resulting fines, restitution, damages and penalties, settlement payments, pleas or exclusion from federal health care programs or other administrative actions, as well as any related actions brought by shareholders or other third parties, could have a material adverse effect on our financial position, results of operations or cash flows. Additionally, these matters could also have a negative impact on our reputation and divert the attention of our management from operating our business. Federal Securities Litigation and Derivative Complaints Federal Securities Litigation. On or about February 2, 2016, a complaint (captioned Richard Di Donato v. Insys Therapeutics, Inc., et al., Case 2:16-cv-00302-NVW) was filed in the United States District Court for the District of Arizona, against us and certain of our current and former officers. The complaint was brought as a purported class action on behalf of purchasers of our common stock between March 3, 2015 and January 25, 2016. In general, the plaintiffs allege that the defendants violated the anti-fraud provisions of the federal securities laws by making materially false and misleading statements regarding our business, operations and compliance with law during the class period, thereby artificially inflating the price of our common stock. On June 3, 2016, the court appointed Clark Miller to serve as lead plaintiff. On June 24, 2016, the plaintiff filed a first amended complaint naming a former employee of Insys Therapeutics, Inc. as an additional defendant and extending the class period. On December 22, 2016, the plaintiff filed a second amended complaint, primarily to add allegations relating to an indictment of Michael L. Babich and certain of our former employees announced on December 8, 2016 and to extend the class period from August 12, 2014 through December 8, 2016. On January 12, 2017, the defendants moved to dismiss the second amended complaint. The plaintiff seeks unspecified monetary damages and other relief. We intend to vigorously defend against this claim. On or about March 17, 2017, a complaint (captioned Kayd Currier v. Insys Therapeutics, Inc., et al., Case 1:17-cv-01954-PAC) was filed in United States District Court for the Southern District of New York, against us and certain of our officers. The complaint was brought as a purported class action on behalf of purchasers of our securities between February 23, 2016 and March 15, 2017. In general, the plaintiffs allege that the defendants violated the anti-fraud provisions of the federal securities laws by making materially false and misleading statements regarding our business and financial results during the class period, thereby artificially inflating the price of our securities. On or about March 28, 2017, a second complaint making similar allegations (captioned Hans E. Erdmann v. Insys Therapeutics, Inc., et al., Case 1:17-cv-02225-PAC) was filed in the same Court. The plaintiffs in both actions seek unspecified monetary damages and other relief. We intend to vigorously defend against these claims. Derivative Litigation. On or about August 26, 2016, Gary Hirt and Precieux Art Jewelers Inc. filed a derivative complaint in the Court of Chancery of Delaware against members of our Board of Directors and Michael L. Babich. The plaintiffs allege, among other things, that the defendants breached their fiduciary duties by (a) knowingly overseeing the implementation of an illegal sales and marketing program, (b) consciously disregarding their duty of oversight of our compliance with law and (c) trading on the basis of material non-public information. On November 8, 2016, the plaintiffs filed an amended derivative complaint, and on January 26, 2017 the plaintiffs supplemented the amended derivative complaint, primarily to add allegations relating to the indictment of Michael L. Babich and certain of our former employees announced on December 8, 2016. On November 22, 2016, the defendants moved to dismiss the action. On or about February 2, 2017, Michael Bourque filed a derivative complaint in the Court of Chancery against members of our Board of Directors; Michael L. Babich; Franc Del Fosse, our General Counsel; and Sanga Emmanuel, our Vice President and Chief Compliance Officer. The Bourque derivative complaint contains similar claims as the other derivative complaint. All parties stipulated to consolidate the two actions, and the consolidated action is captioned In re Insys Therapeutics, Inc. Derivative Litigation, C.A. No. 12696-VCMR. Following the submission of motions for appointment as lead counsel, the Court held a hearing on March 23, 2017, and appointed counsel for Gary Hirt and Precieux Art Jewelers Inc. as lead counsel. Lead counsel is required to designate an operative complaint or file a consolidated complaint. The plaintiffs seek unspecified monetary damages and other relief derivatively on behalf of the company. We intend to vigorously defend against these claims. General Litigation and Disputes Kottayil vs. Insys Pharma, Inc . On September 29, 2009, Insys Pharma, Inc., our wholly owned subsidiary, and certain of our officers and the five directors who comprised the Insys Pharma board of directors as of June 2009, as well as their spouses, were named as defendants in a lawsuit in the Superior Court of the State of Arizona, Maricopa County, or the Arizona Superior Court, brought by Santosh Kottayil, Ph.D., certain of his family members and a trust of which Dr. Kottayil is the trustee. Dr. Kottayil formerly served as President, Chief Scientific Officer and a director of Insys Pharma, among other positions. The complaint brought a cause of action for statutory and common law appraisal of Dr. Kottayil’s Insys Pharma common stock. The cause of action for appraisal relates to a reverse stock split that Insys Pharma effected in June 2009, which resulted in Dr. Kottayil’s ownership position becoming a fractional share of Insys Pharma common stock. Following the reverse stock split, Insys Pharma cancelled all resulting fractional shares, including the fractional share held by Dr. Kottayil, and offered a cash payment in lieu of the fractional shares. The complaint also brought causes of action for breach of fiduciary duty, fraud and negligent misrepresentation in the defendants’ dealings with Dr. Kottayil on the subject of his compensation and stock ownership in Insys Pharma. In January 2010, the plaintiffs added claims seeking to rescind Dr. Kottayil’s assignment to Insys Pharma of his interest in all of the fentanyl and dronabinol patent applications previously assigned to Insys Pharma and to recover the benefits of those interests. Dr. Kottayil was seeking, among other relief, the fair value of his Insys Pharma common stock as of June 2, 2009, compensatory and punitive damages, and rescission of all assignments to Insys Pharma of his interest in the patent applications, as well as attorneys’ fees, costs and interest. In February 2010, Insys Pharma and the other defendants answered and filed counter-claims to Dr. Kottayil’s amended complaint. The counter-claims include actions for breach of fiduciary duty, fraud and negligent misrepresentations and omissions with respect to the time during which Dr. Kottayil was employed at Insys Pharma. The counter-claims, among other relief, sought compensatory and punitive damages. On January 29, 2014, the plaintiffs filed a second amended complaint in the Arizona Superior Court in which Insys Therapeutics, Inc. was also named as defendant in this lawsuit. This amended complaint filed by plaintiffs re-alleged substantially the same claims set forth in the prior complaint, except that plaintiffs also alleged that they were entitled to rescissory damages, added our majority stockholder, a private trust, as a defendant to the breach of fiduciary duty claim and revised their fraud claim against the Insys Pharma director defendants. The trial commenced on December 1, 2014 with the evidence phase of the trial completed on January 29, 2015. On June 8, 2015, the court issued findings of fact and conclusions of law in its final trial ruling. Specifically, the court found (i) in favor of Insys Pharma, our majority stockholder, a private trust and four of the Insys Pharma directors who were on the board in July 2008 on plaintiffs’ claim for breach of fiduciary duty arising out of transactions the board approved in July 2008, (ii) found in favor of plaintiffs and against Insys Pharma, Inc., our majority stockholder, a private trust and three of the Insys Pharma directors who were on the board in June 2009 on plaintiffs’ claims under Delaware law and for breach of fiduciary duties arising out of the reverse stock split the board approved in June 2009 in the amount of $7,317,450, along with pre-judgment and post-judgment interest and court costs, (iii) found in favor of two of the Insys Pharma directors who were on the Insys Pharma board as of June 2009 and against plaintiffs on plaintiffs’ breach of fiduciary duty claims, (iv) found in favor of Insys Pharma and against plaintiff (Kottayil) on his claim for rescission of the patent application assignments that he entered in favor of Insys Pharma before and after his employment terminated, (v) found in favor of Insys Therapeutics, Inc. and against plaintiff on plaintiffs' claims of successor liability and fraudulent transfer, and (vi) found in favor of Kottayil and against Insys Pharma on Insys Pharma’s counterclaims of breach of fiduciary duty, fraud, and negligent misrepresentation. On October 2, 2015, the court entered a final judgment, awarding plaintiffs the amount of $7,317,450, along with pre-judgment interest from June 2, 2009, and post-judgment interest, from October 2, 2015, at the rate of 4.25% per annum, compounded quarterly and taxable costs in the amount of $93,163. On the same date, the court denied Kottayil’s request to submit an application for attorneys’ fees for his defense of the Insys Pharma counterclaims, finding that the request was premature. As a result of the final ruling, we have accrued $9,567,000 at December 31, 2016, including $2,249,000 of estimated pre-judgement interest, which represents our current best estimate of this contingent liability. The final outcome of the appeal could cause this estimate to vary materially from the final award. On October 20, 2015, plaintiffs appealed the foregoing judgment and on November 4, 2015, Insys Pharma and the other defendants against whom judgment was entered filed a notice of cross-appeal. The appeal and cross-appeal remain pending before the Court of Appeals for the State of Arizona. On or around November 1, 2015, we received a notice from the Plaintiff’s attorneys demanding indemnification for legal and other defense costs alleged to have been incurred in connection with Dr. Kottayil’s defense of the Insys Pharma counterclaims in the amount of $3,630,000. We responded to these demands by, among other things, requesting for supporting documents and information from the Plaintiffs’ counsel which we have not received yet. Accordingly, we are still in the process of assessing the merit of such claims as well as evaluating the basis for the costs claimed. Because of the uncertainty surrounding the ultimate outcome we have not accrued for this claim at this time; however, we believe that that it is reasonably possible that there may be a material loss associated with this claim and we currently estimate the range of the reasonably possible loss to be between $0 and the $3,630,000 claimed. As of August 1, 2016, Plaintiffs have filed opening and reply and cross response briefs and we have filed our answering and cross-appeal brief and our reply in support of our cross-appeal. The court has granted but not yet scheduled oral argument. Markland . On July 1, 2016, Robert N. Markland, as the Personal Representative of the Estate of Carolyn S. Markland filed a complaint in the Circuit Court, Fourth Judicial Circuit, in and for Duval County Florida against our parent, Insys Therapeutics, Inc. The complaint states it is a wrongful death products liability action brought pursuant to Section 768.16, et seq. under Florida law in connection with a death occurring in July 2014 and includes a claim of negligent marketing. The lawsuit seeks unspecified damages for past expenses and costs, pain and suffering and loss of consortium and earnings. On August 4, 2016, we removed this case to federal district court in the Middle District of Florida. On September 2, 2016, we filed a motion to dismiss and are awaiting the court’s ruling. We intend to vigorously defend this matter and based on currently available information, we do not believe any resolution of this matter will have a material adverse effect on the Company's business, financial position, or future results of operations. Buchalter . On September 9, 2016, Jeffrey Buchalter filed a complaint in the Circuit Court for Anne Arundel County, Maryland against Dr. William Tham, Physical Medicine & Pain Management Associates, Maryland Neurological Institute, various physician assistants, and Insys Therapeutics, Inc. Plaintiff’s complaint states it is a personal injury action against Insys related to negligent misrepresentation, failure to warn and fraud under state laws. The lawsuit seeks unspecified compensatory and punitive damages. We have filed a motion to sismiss and are awaiting the court’s ruling We intend to vigorously defend this matter and based on currently available information, we do not believe any resolution of this matter will have a m |
Note 8 - Equity
Note 8 - Equity | 12 Months Ended |
Dec. 31, 2016 | |
Equity [Abstract] | |
Equity | 8. Equity Preferred Stock In August 2014, we entered into a Rights Agreement with respect to a newly-designated Series A Junior 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 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 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 were 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 were 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 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 were retroactively restated for the effects of this stock split. Stock Repurchase Program On November 5, 2015, we announced a stock repurchase program. The stock repurchase program authorizes up to $50 million in repurchases of common stock. This program was effective immediately and has no planned expiration date. The following table summarizes our share repurchase activity for our share repurchase program: Number of Shares Purchased Cost of Share Purchases Shares purchased at December 31, 2014 — $ — Shares purchased during 2015 560,200 $ 16,459,000 Shares purchased at December 31, 2015 560,200 $ 16,459,000 Shares purchased during 2016 843,075 16,099,000 Shares purchased at December 31, 2016 1,403,275 $ 32,558,000 As of December 31, 2016, we had $17,442,000 remaining under this program. |
Note 9 - Stock-based Compensati
Note 9 - Stock-based Compensation | 12 Months Ended |
Dec. 31, 2016 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-based Compensation | 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 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, 2016, 1,465,176 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 our Board of Directors that is less than the preceding clause (a). As of December 31, 2016, options to purchase 7,300,873 shares of common stock were outstanding and 4,259,755 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, 2016 2015 2014 (As Revised) Research and development $ 3,931 $ 2,133 $ 5,498 General and administrative 17,658 19,749 9,791 Total cost of stock-based compensation $ 21,589 $ 21,882 $ 15,289 Included in stock-based compensation for the years ended December 31, 2016, 2015 and 2014 was approximately $3,878,000, $4,867,000 and $4,016,000, respectively, of expense associated with the accelerated vesting of option awards related to terminated employees. The following table summarizes stock option activity during the year ended December 31, 2016: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (in Aggregate Intrinsic Value (in millions) Outstanding as of December 31, 2013 8,994,978 $ 1.06 Granted 3,397,198 $ 4.86 Cancelled (1,068,224 ) $ 2.86 Exercised (3,616,790 ) $ 1.15 Outstanding as of December 31, 2014 7,707,162 $ 2.90 Granted 1,733,671 $ 14.57 Cancelled (695,061 ) $ 7.71 Exercised (1,607,683 ) $ 2.48 Outstanding as of December 31, 2015 7,138,089 $ 7.57 Granted 2,337,043 $ 14.86 Cancelled (1,536,538 ) $ 18.67 Exercised (637,721 ) $ 5.96 $ 7.0 Outstanding as of December 31, 2016 7,300,873 $ 12.36 7.3 $ 18.7 Vested and exercisable as of December 31, 2016 4,474,906 $ 9.05 6.4 $ 18.0 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, 2016, we expect to recognize $31,171,000 of stock-based compensation for our outstanding options over a weighted-average period of 2.6 years. The total fair value of shares vested for the years ended December 31, 2016, 2015, and 2014 was $19,970,000, $25,392,000 and $14,572,000, respectively. Cash received from option exercises under all share-based payment arrangements for the years ended December 31, 2016, 2015 and 2014 was $3,803,000, $9,524,000 and $8,956,000, respectively. For the years ended December 31, 2016, 2015 and 2014, we recorded net reductions of $122,000, $13,593,000 and $22,003,000 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: 2016 2015 2014 Expected volatility 63.3 % 69.9 % 69.3 % Risk-free interest rate 1.6 % 1.9 % 1.7 % Expected term (in years) 7.0 7.0 6.0 Expected dividend yield 0.0 % 0.0 % 0.0 % For the years ended December 31, 2016, 2015, and 2014, the weighted-average estimated fair value per option granted was $9.20, $19.20 and $10.53, respectively. |
Note 10 - Income Taxes
Note 10 - Income Taxes | 12 Months Ended |
Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 10. Income Taxes Income tax expense consists of the following (in thousands): Years Ended December 31, 2016 2015 2014 (As Revised) (As Revised) Current income taxes: Federal $ 5,916 $ 31,383 $ 21,949 State and local 554 6,473 3,794 Total current income tax 6,470 37,856 25,743 Deferred income taxes: Federal (7,762 ) (3,759 ) 465 State and local 2,126 (1,156 ) (1,119 ) Total deferred income tax (5,636 ) (4,915 ) (654 ) Income tax expense $ 834 $ 32,941 $ 25,089 As of December 31, 2016, we had approximately $1.1 million of federal 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 $268.1 million of state NOLs at December 31, 2016, all of which relate to Illinois. This $268.1 million of state NOLs excludes $0.6 million of NOLs under ASC Topic 718 that have not been benefitted. Based on projections, we estimate that approximately $266.1 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 $20.6 million. The Illinois NOLs began expiring in 2015 if not utilized. 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): 2016 2015 (As Revised) Deferred income tax assets: NOLs and credits $ 27,046 $ 26,910 Start-up expenditures 2,604 2,896 Stock-based compensation 11,727 8,578 Allowances 1,264 1,581 Expenses currently not deductible for tax purposes 10,652 6,129 Other 1,963 1,142 Gross deferred tax assets 55,256 47,236 Deferred income tax asset valuation allowance (23,508 ) (20,203 ) Deferred income tax assets 31,748 27,033 Deferred income tax liabilities: Federal impact of state taxes (1,073 ) (1,817 ) Property and equipment (6,246 ) (6,189 ) Prepaid expenses (1,186 ) (1,420 ) Net deferred income tax assets $ 23,243 $ 17,607 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 Arizona research and development credit and 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 a portion of our Arizona research and development credit and our Illinois NOLs of $23.5 million, no other valuation allowance exists on our deferred tax assets at December 31, 2016. We have increased the valuation allowance by $3.3 million from December 31, 2015. Effective Tax Rate Reconciliation: Our federal statutory tax rate is 35.0%, while our effective tax rate was 9.9% for the year ended December 31, 2016, as set forth below: 2016 2015 2014 (As Revised) (As Revised) 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 (0.1 )% 2.3 % 4.1 % Non-deductible litigation expense 3.4 % 3.5 % 3.2 % Non-deductible and includible items 7.5 % 0.7 % 0.7 % Non-deductible lobbying expense 8.3 % — — Research and other credits (63.5 )% (5.4 )% (3.6 )% Uncertain tax positions 4.2 % 2.7 % 1.9 % Domestic manufacturing deduction (14.6 )% (3.0 )% (0.3 )% Stock based compensation 5.1 % 0.4 % 0.1 % Tax exempt interest income (1.5 )% — — Other 0.6 % — — Change in valuation allowance 25.5 % (0.1 )% — Total provision for income taxes 9.9 % 36.1 % 41.1 % The following is a reconciliation of the beginning and ending amounts of unrecognized tax benefits (in thousands): Years Ended December 31, 2016 2015 (As Revised) Beginning balance $ 8,920 $ 5,323 Additions based on current year's tax positions 758 3,837 Additions based on prior year's tax positions 122 (240 ) Ending balance $ 9,800 $ 8,920 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 $9,800,000 as of December 31, 2016, mostly related to tax credits of $2,610,000, state and local income tax filing positions of $5,412,000, and $1,778,000 of other permanent differences. Although it is reasonably possible 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 similar activities, we do not anticipate any significant changes to unrecognized tax benefits over the next 12 months. Approximately $706,000 of interest has been included in income taxes and accounted for on the balance sheet related to unrecognized tax positions as of December 31, 2016. We are currently under examination in the U.S. for tax years 2014 and 2015. Because of NOLs and research credit carryovers, substantially all of our tax years remain open to examination. |
Note-11 - Net Income per Share
Note-11 - Net Income per Share | 12 Months Ended |
Dec. 31, 2016 | |
Earnings Per Share [Abstract] | |
Net Income per Share | 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, 2016 2015 2014 (As Revised) (As Revised) Historical net income per share - Basic Numerator: Net income $ 7,590 $ 58,053 $ 36,054 Denominator: Weighted average number of common shares outstanding 71,618,793 71,592,581 68,759,070 Basic net income per common share $ 0.11 $ 0.81 $ 0.52 Historical net income per share - Diluted Numerator: Net income $ 7,590 $ 58,053 $ 36,054 Denominator: Weighted average number of common shares outstanding 71,618,793 71,592,581 68,759,070 Effect of dilutive stock options 2,527,125 4,115,070 4,576,062 Weighted average number of common shares outstanding 74,145,918 75,707,651 73,335,132 Diluted net income per common share $ 0.10 $ 0.77 $ 0.49 The calculation of diluted net income per common share excludes the effects of 2,596,324, 1,460,986 and 1,780,372 outstanding stock options for the year ended December 31, 2016, 2015, 2014, respectively, as the impact of these options was anti-dilutive. |
Note 12 - Product Lines, Concen
Note 12 - Product Lines, Concentration of Credit Risk and Significant Customers | 12 Months Ended |
Dec. 31, 2016 | |
Segment Reporting [Abstract] | |
Product Lines, Concentration of Credit Risk and Significant Customers | 12. Product Lines, Concentration of Credit Risk and Significant Customers We are engaged in the business of developing and selling pharmaceutical products. In 2016, we have one product line, SUBSYS®. Our chief operating decision-maker evaluates revenues based on product lines. The following tables summarize our net revenue by product line, as well as the percentages of revenue by route to market (in thousands): Net Revenue by Product Line Years Ended December 31, 2016 2015 2014 (As Revised) (As Revised) Subsys $ 242,275 $ 329,040 $ 216,497 Dronabinol SG Capsule — 1,283 2,595 Total net revenue $ 242,275 $ 330,323 $ 219,092 Percent of Revenue by Route to Market Years Ended December 31, 2016 2015 2014 Pharmaceutical wholesalers 67 % 95 % 99 % Specialty pharmaceutical retailers 33 % 5 % 0 % Generic pharmaceutical distributors 0 % 0 % 1 % 100 % 100 % 100 % All our products are sold in the United States of America. Product shipments to our four largest pharmaceutical wholesaler customers accounted for 17%, 16%, 15% and 14% of total shipments and product shipments to one specialty pharmaceutical retailer accounted for 32% of total shipments for the year ended December 31, 2016. Product shipments to our four largest pharmaceutical wholesaler customers accounted for 32%, 20%, 17% and 14% of total shipments for the year ended December 31, 2015. Product shipments to our four largest pharmaceutical wholesaler customers accounted for 38%, 22%, 14% and 14% of shipments of SUBSYS® for the year ended December 31, 2014. Four pharmaceutical wholesalers’ accounts receivable balances accounted for 36%, 23%, 21% and 13% of gross accounts receivable as of December 31, 2016. Four pharmaceutical wholesalers’ accounts receivable balances accounted for 20%, 19%, 17% and 14% of gross accounts receivable as of December 31, 2015. 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 are exposed to credit risk in the event of a default by the institutions holding our cash to the extent recorded on the consolidated balance sheet. 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, 2016 | |
Valuation And Qualifying Accounts [Abstract] | |
Supplemental Financial Information | 13. Supplemental Financial Information A summary of additions and deductions related to the allowances for accounts receivable for the years ended December 31, 2016, 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, 2016 $ 811 $ (96 ) $ (30 ) $ 685 Year ended December 31, 2015 $ 398 $ 413 $ — $ 811 Year ended December 31, 2014 $ — $ 398 $ — $ 398 Allowance for sales wholesaler discounts, prompt pay discounts, stocking allowances, and chargebacks: Year ended December 31, 2016 $ 7,556 $ 27,968 $ (30,065 ) $ 5,459 Year ended December 31, 2015 (As Revised) $ 5,418 $ 38,036 $ (35,898 ) $ 7,556 Year ended December 31, 2014 (As Revised) $ 2,748 $ 22,395 $ (19,725 ) $ 5,418 |
Note 14 - Quarterly Results of
Note 14 - Quarterly Results of Operations (Unaudited) | 12 Months Ended |
Dec. 31, 2016 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Financial Information | 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, 2016. We have derived this data from our unaudited condensed consolidated interim financial statements that, in our opinion, have been prepared on substantially the same basis as the audited consolidated 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 consolidated 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. As discussed in Note 2, our management concluded that the errors related to the miscalculation of rebate obligations on government payer and managed care contracts in addition to the out-of-period adjustments related to stock option modifications during the three months ended March 31, 2016 and the accounting for tax benefits associated with accrued litigation award and settlements recorded during 2016, were not material to our consolidated financial statements for the years ended December 31, 2015 and 2014. However, to correctly present net revenue in the appropriate period during 2016 and 2015, our unaudited condensed consolidated interim financial statements as of and for the quarters ended September 30, June 30, and March 31, 2016 and 2015 will be restated in Quarterly Reports on Form 10-Q/A to make the necessary accounting adjustments in the corresponding quarterly periods. The adjustments shown below represent the impact of the correction of errors to previously issued unaudited condensed consolidated interim financial information as described in Note 2 (in thousands, except per share data). Quarter Ended 12/31/16 9/30/16 6/30/16 3/31/16 Net revenue - as originally reported $ 54,860 $ 55,180 $ 67,121 $ 61,962 Adjustment - prior period underestimation of sales allowances — 2,593 2,100 (1,541 ) Net revenue (As Restated) $ 54,860 $ 57,773 $ 69,221 $ 60,421 Gross profit (1) - as originally reported $ 45,055 $ 50,503 $ 60,848 $ 57,324 Adjustment - prior period underestimation of sales allowances — 2,593 2,100 (1,541 ) Gross profit (1) (As Restated) $ 45,055 $ 53,096 $ 62,948 $ 55,783 Total operating expenses - as originally reported $ 48,688 $ 50,831 $ 56,504 $ 55,033 Adjustment - prior period stock option modification — — — (1,500 ) Total operating expenses (As Restated) $ 48,688 $ 50,831 $ 56,504 $ 53,533 Income (loss) before income taxes - as originally reported $ (3,341 ) $ (47 ) $ 4,595 $ 2,565 Adjustment — 2,593 2,100 (41 ) Income before income taxes (As Restated) $ (3,341 ) $ 2,546 $ 6,695 $ 2,524 Income tax expense (benefit) - as originally reported $ 311 $ (237 ) $ 240 $ 131 Adjustment — (142 ) 428 103 Income tax expense (benefit) (As Restated) $ 311 $ (379 ) $ 668 $ 234 Net income (loss) (2) - as originally reported $ (3,652 ) $ 190 $ 4,355 $ 2,434 Adjustment — 2,735 1,672 (144 ) Net income (loss) (2) (As Restated) $ (3,652 ) $ 2,925 $ 6,027 $ 2,290 Total comprehensive income (loss) - as originally reported $ (3,880 ) $ 32 $ 4,425 $ 2,600 Adjustment — 2,735 1,672 (144 ) Total comprehensive income (loss) (As Restated) $ (3,880 ) $ 2,767 $ 6,097 $ 2,456 Net income (loss) per common share: Basic - as originally reported $ (0.05 ) $ — $ 0.06 $ 0.03 Adjustment — 0.04 0.02 0.00 Basic (As Restated) $ (0.05 ) $ 0.04 $ 0.08 $ 0.03 Diluted - as originally reported $ (0.05 ) $ — $ 0.06 $ 0.03 Adjustment — 0.04 0.02 0.00 Diluted (As Restated) $ (0.05 ) $ 0.04 $ 0.08 $ 0.03 Quarter Ended 12/31/15 9/30/15 6/30/15 3/31/15 Net revenue - as originally reported $ 91,135 $ 91,259 $ 77,633 $ 70,770 Adjustment - prior period underestimation of sales allowances 2,779 (2,742 ) 2,567 (3,078 ) Net revenue (As Restated) $ 93,914 $ 88,517 $ 80,200 $ 67,692 Gross profit - as originally reported $ 84,668 $ 83,552 $ 69,328 $ 64,395 Adjustment - prior period underestimation of sales allowances 2,779 (2,742 ) 2,567 (3,078 ) Gross profit (As Restated) $ 87,447 $ 80,810 $ 71,895 $ 61,317 Total operating expenses - as originally reported $ 54,948 $ 44,431 $ 57,370 $ 52,764 Adjustment - prior period stock option modification 1,500 — — — Total operating expenses (As Restated) $ 56,448 $ 44,431 $ 57,370 $ 52,764 Income before income taxes - as originally reported $ 29,907 $ 39,212 $ 12,093 $ 11,756 Adjustment 1,279 (2,742 ) 2,567 (3,078 ) Income before income taxes (As Restated) $ 31,186 $ 36,470 $ 14,660 $ 8,678 Income tax expense - as originally reported $ 12,896 $ 13,084 $ 4,779 $ 3,733 Adjustment 147 (1,244 ) 468 (922 ) Income tax expense (As Restated) $ 13,043 $ 11,840 $ 5,247 $ 2,811 Net income - as originally reported $ 17,011 $ 26,128 $ 7,314 $ 8,023 Adjustment 1,132 (1,498 ) 2,099 (2,156 ) Net income (As Restated) $ 18,143 $ 24,630 $ 9,413 $ 5,867 Total comprehensive income - as originally reported $ 16,826 $ 26,178 $ 7,293 $ 8,051 Adjustment 1,132 (1,498 ) 2,099 (2,156 ) Total comprehensive income (As Restated) $ 17,958 $ 24,680 $ 9,392 $ 5,895 Net income per common share: Basic - as originally reported $ 0.24 $ 0.36 $ 0.10 $ 0.11 Adjustment 0.01 (0.02 ) 0.03 (0.03 ) Basic (As Restated) $ 0.25 $ 0.34 $ 0.13 $ 0.08 Diluted - as originally reported $ 0.22 $ 0.34 $ 0.10 $ 0.11 Adjustment 0.02 (0.02 ) 0.02 (0.03 ) Diluted (As Restated) $ 0.24 $ 0.32 $ 0.12 $ 0.08 (1) The fourth quarter of 2016 includes an allowance of $5,800,000 for excess and obsolete SUBSYS® inventory. (2) The fourth quarter of 2016 includes charges related to litigation award and settlements of $3,900,000. |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2016 | |
Accounting Policies [Abstract] | |
Revision of Previously Issued Financial Statements for Correction of Immaterial Errors | Revision of Previously Issued Financial Statements for Correction of Immaterial Errors During the three months ended September 30, 2016, we identified an error related to the accounting for the rebates component of our product sales allowances since 2014.. We determined that we had incorrectly applied the accounting guidance in Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) No. 605, “Revenue Recognition” by miscalculating our rebate obligations on government payer and managed care contracts. In addition, we recorded out-of-period adjustments that resulted in an increase in operating expenses of $1,500,000 related to stock option modifications during the three months ended March 31, 2016 and a decrease in income tax expense of $834,000 related to the deductible interest expense portion of the accrued litigation award and settlements recorded during 2016. We assessed the materiality of these errors on our prior annual financial statements, assessing materiality both quantitatively and qualitatively, in accordance with the SEC’s Staff Accounting Bulletin (“SAB”) No. 99 and SAB No. 108 and concluded that the errors were not material to our consolidated financial statements for the years ended December 31, 2015 and 2014. However, to correctly present net revenue, operating expenses and income tax expense in the appropriate periods, management revised its previously issued financial statements for the years ended December 31, 2015 and 2014. Certain amounts in prior periods as previously reported have been reclassified to conform to the current period presentation. The following tables summarize the impact and financial statement line items impacted by the revision adjustments as of and for the years ended December 31, 2015 and 2014 : As of December 31, 2015 (in thousands) Consolidated Balance Sheet: As previously reported Adjustments As revised Deferred income tax assets, net 16,331 1,276 17,607 Total assets 350,009 1,276 351,285 Accounts payable and accrued expenses 36,354 (743 ) 35,611 Accrued sales allowances 31,526 3,507 35,033 Total current liabilities 87,672 2,764 90,436 Uncertain income tax position 8,635 (91 ) 8,544 Total liabilities 96,307 2,673 98,980 Additional paid in capital 245,736 949 246,685 Retained earnings 7,420 (2,346 ) 5,074 Total stockholders' equity 253,702 (1,397 ) 252,305 Total liabilities and stockholders' equity $ 350,009 $ 1,276 $ 351,285 Year Ended December 31, 2015 (in thousands, except per share data) Consolidated Statement of Comprehensive Income: As previously reported Adjustments As revised Net revenue $ 330,797 $ (474 ) $ 330,323 Gross profit 301,943 (474 ) 301,469 Operating expenses: Research and development 55,281 1,500 56,781 Total operating expenses 209,513 1,500 211,013 Operating income 92,430 (1,974 ) 90,456 Income before income taxes 92,968 (1,974 ) 90,994 Less: income tax expense 34,492 (1,551 ) 32,941 Net income 58,476 (423 ) 58,053 Total comprehensive income $ 58,348 $ (423 ) $ 57,925 Net income per common share: Basic $ 0.82 $ (0.01 ) $ 0.81 Diluted $ 0.77 $ (0.00 ) $ 0.77 Year Ended December 31, 2015 (in thousands) Consolidated Statement of Cash Flows: As previously reported Adjustments As revised Cash flows from operating activities: Stock-based compensation $ 20,382 $ 1,500 $ 21,882 Deferred income tax benefit (4,118 ) (796 ) (4,914 ) Excess tax benefits on stock options and awards (13,593 ) (3 ) (13,596 ) Prepaid expenses and other current assets 1,311 34 1,345 Accounts payable, accrued expenses and other current liabilities 51,023 (315 ) 50,708 Net cash provided by operating activities 102,281 (3 ) 102,278 Cash flows from financing activities: Excess tax benefits on stock options and awards 13,593 3 13,596 Net cash provided by financing activities $ 9,305 $ 3 $ 9,308 As of December 31, 2014 (in thousands) Consolidated Statement of Stockholders' Equity: As previously reported Adjustments As revised Additional paid in capital 216,061 (554 ) 215,507 Retained earnings (51,056 ) (1,923 ) (52,979 ) Total stockholders' equity 165,667 (2,477 ) 163,190 Total liabilities and stockholders' equity $ 215,121 $ 514 $ 215,635 Year Ended December 31, 2014 (in thousands) Consolidated Statement of Comprehensive Income: As previously reported Adjustments As revised Net revenue $ 222,125 $ (3,033 ) $ 219,092 Gross profit 199,547 (3,033 ) 196,514 Operating income 64,023 (3,033 ) 60,990 Income before income taxes 64,176 (3,033 ) 61,143 Less: income tax expense 26,199 (1,110 ) 25,089 Net income 37,977 (1,923 ) 36,054 Total comprehensive income $ 37,953 $ (1,923 ) $ 36,030 Net income per common share: Basic $ 0.55 $ (0.03 ) $ 0.52 Diluted $ 0.52 $ (0.03 ) $ 0.49 Year Ended December 31, 2014 (in thousands) Consolidated Statement of Cash Flows: As previously reported Adjustments As revised Cash flows from operating activities: Deferred income tax benefit (175 ) (480 ) (655 ) Excess tax benefits on stock options and awards (22,003 ) 554 (21,449 ) Prepaid expenses and other current assets (2,933 ) (34 ) (2,967 ) Accounts payable, accrued expenses and other current liabilities 50,376 2,437 52,813 Net cash provided by operating activities 50,031 554 50,585 Cash flows from financing activities: Excess tax benefits on stock options and awards 22,003 (554 ) 21,449 Net cash provided by financing activities $ 32,948 $ (554 ) $ 32,394 |
Principles of Consolidation | Principles of Consolidation The consolidated financial statements include the accounts of Insys Therapeutics, Inc. and its wholly-owned subsidiaries. All significant intercompany balances and transactions have been eliminated in the accompanying consolidated financial statements. |
Reclassification | Reclassification Certain amounts in prior periods have been reclassified to conform to the current period presentation. |
Fair Value of Financial Instruments | 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. FASB ASC No. 820, “Fair Value Measurement” defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. It also establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows: Level 1: Observable inputs such as quoted prices in active markets; Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions. |
Revenue Recognition | Revenue Recognition We recognize revenue from the sale of SUBSYS®. Revenue is recognized when (i) persuasive evidence of an arrangement exists, (ii) delivery has occurred and title has passed, (iii) the price is fixed or determinable and (iv) collectability is reasonably assured. SUBSYS® 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 to wholesale pharmaceutical distributors and directly to specialty retail pharmacies (collectively, our customers) subject to rights of return within a period beginning six months prior to, and ending 12 months following, product expiration. SUBSYS® currently has a shelf life of 36 months from the date of manufacture. We record revenue for SUBSYS® at the time the customer receives the shipment. We recognize estimated product sales allowances as a reduction of product sales in the same period the related revenue is recognized. Product sales allowances are based on amounts owed or to be claimed on the related sales. These estimates take into consideration the terms of our agreements with customers and third-party payers and the levels of inventory within the distribution channels that may result in future discounts taken. In certain cases, such as patient assistance programs, we recognize the cost of patient discounts as a reduction of revenue based on estimated utilization. If actual future results vary, we may need to adjust these estimates, which could have an effect on product revenue in the period of adjustment. Our product sales allowances include: Product Returns. We allow customers to return product for credit within six months before and up to 12 months following its product expiration date. The shelf life of SUBSYS® is currently 36 months from the date of manufacture. We have monitored actual return history since product launch, which provides us with a basis to reasonably estimate future product returns, taking into consideration the shelf life of product at the time of shipment, shipment and prescription trends, estimated distribution channel inventory levels, and consideration of the introduction of competitive products. Because of the shelf life of our products and our return policy of issuing credits on returned product that is within six months before and up to 12 months after 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. We offer discounts to certain wholesale distributors based on contractually determined rates. We accrue the discount as a reduction of receivables due from the wholesalers upon shipment to the respective wholesale distributors and retail pharmacies. Prompt Pay Discounts. We offer cash discounts to our customers, generally 2.0% of the sales price, as an incentive for prompt payment. We account for cash discounts by reducing accounts receivable by the full amount of the discount. Stocking Allowances. We may offer discounts and extended payment terms, generally in the month of the initial commercial launch of a new product and on the first order made by certain wholesale distributors and retail pharmacies based on contractually determined rates. We accrue the discount as a reduction of receivables due from the wholesalers upon shipment to the respective wholesale distributors and retail pharmacies. Patient Discount Programs . We offer discount card programs to patients for SUBSYS® in which patients receive discounts on their prescriptions that are reimbursed by us to the retailer. We estimate the total amount that will be redeemed based on a percentage of actual redemption applied to inventory in the distribution and retail channels. The allowance for patient discount programs is included in accrued sales allowances. Rebates. We participate in certain rebate programs, which provide discounted prescriptions to qualified insured patients. Under these rebate programs, we pay a rebate to the third-party administrator of the program, generally two to three months after the quarter in which prescriptions subject to the rebate are filled. We estimate and accrue these rebates based on current contract prices, historical and estimated future percentages of products sold to qualified patients and estimated levels of inventory in the distribution channel. The allowance for rebates is included in accrued sales allowances. Chargebacks. We provide discounts primarily to authorized users of the FSS of the General Services Administration under an FSS contract negotiated by the Department of Veterans Affairs and various organizations under Medicaid contracts and regulations. These entities purchase products from the wholesale distributors at a discounted price, and the wholesale distributors then charge back to us the difference between the current retail price and the price the entity paid for the product. We estimate and accrue chargebacks based on estimated wholesaler inventory levels, current contract prices and historical chargeback activity. The allowance for chargebacks is included as a reduction to accounts receivable. Dronabinol SG Capsule Our Dronabinol SG Capsule product was commercially launched in December 2011, and we sold Dronabinol SG Capsule exclusively to Mylan in the United States under a supply and distribution agreement. We do not have any current plans to manufacture or market this product in the future. |
Cash and Cash Equivalents | 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 | 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 and commercial paper are carried at cost which approximates fair value. We classify our marketable securities as available-for-sale in accordance with FASB ASC Topic 320, Investments — Debt and Equity Securities. |
Accounts Receivable, Net | 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. In the ordinary course of business, and consistent with industry practices, we may from time to time offer extended payment terms to our customers as an incentive for new product launches or in other circumstances. These extended payment terms do not represent a significant risk to the collectability of accounts receivable as of the period-end and are evaluated in accordance with ASC 605 —Revenue Recognition |
Inventories | 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 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 | 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 losses (“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 operating results. 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 consolidated statements of comprehensive income. |
Research and Development Expenses | 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 Advertising and marketing costs are expensed as incurred. Advertising expense totaled $1,572,000, $1,166,000 and $800,000 for the years ended December 31, 2016, 2015 and 2014, respectively. |
Legal Fees | 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 $22,840,000, $19,448,000 and $16,926,000 for the years ended December 31, 2016, 2015 and 2014, respectively. |
Stock-Based Compensation Expenses | 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, which is generally three to four years, on a straight-line basis. 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 | Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America (“U.S. 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 | 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 | Recent Accounting Pronouncements In October 2016, the FASB issued ASU No. 2016-16, Income Taxes (Topic 740): Intra-Entity Transfers of Assets Other Than Inventory, to improve the accounting for the income tax consequences of intra-entity transfers of assets other than inventory. Current U. S. GAAP prohibits the recognition of current and deferred income taxes for an intra-entity asset transfer until the asset has been sold to an outside party, which is an exception to the principle of comprehensive recognition of current and deferred income taxes in U. S. GAAP. The amendments in this update eliminate the exception for an intra-entity transfer of an asset other than inventory. The amendments should be applied on a modified retrospective transition basis, and are effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years, and early adoption is permitted. We are currently evaluating the impact of these amendments on our consolidated financial statements. In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments. The amendments affect entities required to present a statement of cash flows and provides specific guidance on a variety of cash flow issues to reduce current and potential future diversity in practice. The amendments are effective for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years, and early adoption is permitted. An entity that elects early adoption must adopt all of the amendments in the same period. The amendments should be applied using a retrospective transition method to each period presented. We are currently evaluating the impact of these amendments on our consolidated financial statements. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. The amendments affect entities holding financial assets and net investment in leases that are not accounted for at fair value through net income, and are effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years, and early adoption is permitted. ASU 2016-13 amends the impairment model to utilize an expected loss methodology in place of the currently used incurred loss methodology, which will result in the timelier recognition of losses. We are currently evaluating the impact of these amendments on our consolidated financial statements. In March 2016, the FASB issued ASU No. 2016-09, Compensation-Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting, to reduce complexity in accounting standards involving several aspects of the accounting for employee share-based payment transactions, including (1) the income tax consequences, (2) classification of awards as either equity or liabilities, and (3) classification in the statement of cash flows. The amendments will be effective for financial statements issued for fiscal years beginning after December 15, 2016, including interim periods within those fiscal years. Amendments related to the timing of when excess tax benefits are recognized, minimum statutory withholding requirements, forfeitures, and intrinsic value should be applied using a modified retrospective transition, amendments related to the presentation of employee taxes paid on the statement of cash flows when an employer withholds shares to meet the minimum statutory withholding requirement should be applied retrospectively, amendments requiring recognition of excess tax benefits and tax deficiencies in the income statement and the practical expedient for estimating expected term should be applied prospectively, and amendments related to the presentation of excess tax benefits on the statement of cash flows can be applied using either a prospective transition method or a retrospective transition method. We will adopt the new guidance in the first quarter of 2017. Under the new guidance, excess tax benefits related to equity compensation will be recognized in the provision for income taxes in the consolidated statements of comprehensive income rather than in additional paid-in capital in the consolidated balance sheets and will be applied on a prospective basis. We have not yet determined our selected method of transition for changes to the statements of cash flows related to the classification of excess tax benefits and employee taxes paid for share-based payment arrangements. The related financial statement impacts of adopting the above aspects of this ASU are not expected to be material. However, depending on several factors such as the market price of our common stock, employee exercise behavior and corporate income tax rates, the excess tax benefits associated with the exercise of stock options could generate a significant discrete income tax benefit in a particular interim period potentially creating volatility in net income and net income per share period-to-period and period-over-period. In February 2016, the FASB issued ASU No. 2016-02, Leases: (Topic 842), to provide guidance on recognizing lease assets and lease liabilities on the balance sheet and disclosing key information about leasing arrangements, specifically differentiating between different types of leases. The core principle of Topic 842 is that a lessee should recognize the assets and liabilities that arise from all leases. The recognition, measurement, and presentation of expenses and cash flows arising from a lease by a lessee have not significantly changed from previous U.S. GAAP guidance. There continues to be a differentiation between finance leases and operating leases. However, the principal difference from previous guidance is that the lease assets and lease liabilities arising from operating leases should be recognized in the balance sheet. The accounting applied by a lessor is largely unchanged from that applied under previous U.S. GAAP guidance. The amendments will be effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years, and early adoption is permitted. In transition, lessees and lessors are required to recognize and measure leases at the beginning of the earliest period presented using a modified retrospective approach. The modified retrospective approach includes a number of optional practical expedients that entities may elect to apply. These practical expedients relate to the identification and classification of leases that commenced before the effective date, initial direct costs for leases that commenced before the effective date, and the ability to use hindsight in evaluating lessee options to extend or terminate a lease or to purchase the underlying asset. An entity that elects to apply the practical expedients will, in effect, continue to account for leases that commence before the effective date in accordance with previous U.S. GAAP guidance unless the lease is modified, except that lessees are required to recognize a right-of-use asset and a lease liability for all operating leases at each reporting date based on the present value of the remaining minimum rental payments that were tracked and disclosed under previous U.S. GAAP guidance. We are currently evaluating the impact of these amendments on our consolidated financial statements and related disclosures; however, based on our current operating leases, we do not expect that the adoption of this guidance will have a material impact on the consolidated financial statements. See Note 7, Commitments and Contingencies, In January 2016, the FASB issued ASU No. 2016-01, Financial Instruments—Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities, which amended the Financial Instruments topic of the ASC to address certain aspects of recognition, measurement, presentation, and disclosure of financial instruments. The amendments will be effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years, and early adoption is not permitted. These amendments should be applied by means of a cumulative-effect adjustment to the balance sheet as of the beginning of the fiscal year of adoption. The amendments related to equity securities without readily determinable fair values (including disclosure requirements) should be applied prospectively to equity investments that exist as of the date of adoption. We are currently evaluating the impact of these amendments on our consolidated financial statements. In July 2015, the FASB issued ASU No. 2015-11, Inventory (Topic 330): Simplifying the Measurement of Inventory. The guidance requires entities to measure most inventory at the lower of cost and NRV, thereby simplifying the current guidance under which an entity must measure inventory at the lower of cost or market. Under the new guidance, inventory is measured at the lower of cost and NRV, which eliminates the need to determine replacement cost and evaluate whether it is above the ceiling (NRV) or below the floor (NRV less a normal profit margin). The guidance defines NRV as the “estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation.” The guidance is effective for annual periods beginning after December 15, 2016, and interim periods therein. We will adopt the new guidance in the first quarter of 2017. We do not believe that the adoption of this guidance will have a material impact on our consolidated financial statements. In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606). The new standard aims to achieve a consistent application of revenue recognition within the United States, resulting in a single revenue model to be applied by reporting companies under U.S. GAAP. Under the new model, recognition of revenue occurs when a customer obtains control of promised goods or services in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. In addition, the new standard requires that reporting companies disclose the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers. The new standard is required to be applied either retrospectively to each prior reporting period presented or retrospectively with the cumulative effect of initially applying it recognized at the date of initial application. In March 2016 and April 2016, the FASB issued ASU No. 2016-08 and ASU No. 2016-10, respectively, which further clarified the implementation guidance on principal versus agent considerations contained in ASU No. 2014-09 and the identification of performance obligations and licensing, respectively. In May 2016, the FASB issued ASU 2016-12, narrow-scope improvements and practical expedients which provides clarification on assessing the collectability criterion, presentation of sales taxes, measurement date for non-cash consideration and completed contracts at transition. These standards will be effective for annual periods beginning after December 15, 2017, and interim periods therein, using either of the following transition methods: (i) a full retrospective approach reflecting the application of the standard in each prior reporting period with the option to elect certain practical expedients, or (ii) a retrospective approach with the cumulative effect of initially adopting ASU 2014-09 recognized at the date of adoption (which includes additional footnote disclosures). Early adoption is permitted, but not before December 15, 2016, the original effective date of the standard. We are currently analyzing ASU 2014-09, and the related ASU's, to evaluate the impact of the new standard on existing contracts with our customers. This includes reviewing current accounting policies and practices to identify potential differences that would result from applying the requirements under the new standard. We initiated a contract review process during 2016 and expect to complete the contract evaluations and validate results by the end of the second quarter of 2017. We have also started evaluating our existing accounting policies and the new disclosure requirements and expect to complete our evaluation of the impacts of the accounting and disclosure requirements on our business processes, controls and systems by the end of the second quarter of 2017. Full implementation will be completed by the end of 2017. We have not yet determined our selected method of transition. |
Note 2 - Significant Accounti22
Note 2 - Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Accounting Policies [Abstract] | |
Summary of Amounts and Financial Statement Line Items Impacted by Revisions | The following tables summarize the impact and financial statement line items impacted by the revision adjustments as of and for the years ended December 31, 2015 and 2014 : As of December 31, 2015 (in thousands) Consolidated Balance Sheet: As previously reported Adjustments As revised Deferred income tax assets, net 16,331 1,276 17,607 Total assets 350,009 1,276 351,285 Accounts payable and accrued expenses 36,354 (743 ) 35,611 Accrued sales allowances 31,526 3,507 35,033 Total current liabilities 87,672 2,764 90,436 Uncertain income tax position 8,635 (91 ) 8,544 Total liabilities 96,307 2,673 98,980 Additional paid in capital 245,736 949 246,685 Retained earnings 7,420 (2,346 ) 5,074 Total stockholders' equity 253,702 (1,397 ) 252,305 Total liabilities and stockholders' equity $ 350,009 $ 1,276 $ 351,285 Year Ended December 31, 2015 (in thousands, except per share data) Consolidated Statement of Comprehensive Income: As previously reported Adjustments As revised Net revenue $ 330,797 $ (474 ) $ 330,323 Gross profit 301,943 (474 ) 301,469 Operating expenses: Research and development 55,281 1,500 56,781 Total operating expenses 209,513 1,500 211,013 Operating income 92,430 (1,974 ) 90,456 Income before income taxes 92,968 (1,974 ) 90,994 Less: income tax expense 34,492 (1,551 ) 32,941 Net income 58,476 (423 ) 58,053 Total comprehensive income $ 58,348 $ (423 ) $ 57,925 Net income per common share: Basic $ 0.82 $ (0.01 ) $ 0.81 Diluted $ 0.77 $ (0.00 ) $ 0.77 Year Ended December 31, 2015 (in thousands) Consolidated Statement of Cash Flows: As previously reported Adjustments As revised Cash flows from operating activities: Stock-based compensation $ 20,382 $ 1,500 $ 21,882 Deferred income tax benefit (4,118 ) (796 ) (4,914 ) Excess tax benefits on stock options and awards (13,593 ) (3 ) (13,596 ) Prepaid expenses and other current assets 1,311 34 1,345 Accounts payable, accrued expenses and other current liabilities 51,023 (315 ) 50,708 Net cash provided by operating activities 102,281 (3 ) 102,278 Cash flows from financing activities: Excess tax benefits on stock options and awards 13,593 3 13,596 Net cash provided by financing activities $ 9,305 $ 3 $ 9,308 Year Ended December 31, 2014 (in thousands) Consolidated Statement of Comprehensive Income: As previously reported Adjustments As revised Net revenue $ 222,125 $ (3,033 ) $ 219,092 Gross profit 199,547 (3,033 ) 196,514 Operating income 64,023 (3,033 ) 60,990 Income before income taxes 64,176 (3,033 ) 61,143 Less: income tax expense 26,199 (1,110 ) 25,089 Net income 37,977 (1,923 ) 36,054 Total comprehensive income $ 37,953 $ (1,923 ) $ 36,030 Net income per common share: Basic $ 0.55 $ (0.03 ) $ 0.52 Diluted $ 0.52 $ (0.03 ) $ 0.49 Year Ended December 31, 2014 (in thousands) Consolidated Statement of Cash Flows: As previously reported Adjustments As revised Cash flows from operating activities: Deferred income tax benefit (175 ) (480 ) (655 ) Excess tax benefits on stock options and awards (22,003 ) 554 (21,449 ) Prepaid expenses and other current assets (2,933 ) (34 ) (2,967 ) Accounts payable, accrued expenses and other current liabilities 50,376 2,437 52,813 Net cash provided by operating activities 50,031 554 50,585 Cash flows from financing activities: Excess tax benefits on stock options and awards 22,003 (554 ) 21,449 Net cash provided by financing activities $ 32,948 $ (554 ) $ 32,394 |
Note 3 - Short-term and Long-23
Note 3 - Short-term and Long-term Investments (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Schedule Of Investments [Abstract] | |
Summary of Investments | Investments consisted of the following at December 31, 2016 (in thousands): December 31, 2016 Cost Unrealized Gains Unrealized Losses Other- Than- Temporary Impairment Losses Fair Value Cash and Cash Equivalents Short-term Investments Long-term Investments Cash $ 49,331 $ — $ — $ — $ 49,331 $ 49,331 $ — $ — Money market securities 54,015 — — — 54,015 54,015 — — Marketable securities: Certificates of deposit 26,114 — — — 26,114 — 13,855 12,259 Commercial paper 1,485 — — — 1,485 — 1,485 — Corporate securities 39,562 — (135 ) — 39,427 500 25,681 13,246 Federal agency securities 30,660 4 (92 ) — 30,572 — 10,854 19,718 Municipal securities 35,811 2 (81 ) — 35,732 796 26,363 8,573 Total marketable securities 133,632 6 (308 ) — 133,330 1,296 78,238 53,796 $ 236,978 $ 6 $ (308 ) $ — $ 236,676 $ 104,642 $ 78,238 $ 53,796 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 — — Marketable securities: Certificates of deposit 26,223 — — — 26,223 — 16,637 9,586 Commercial paper 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 126,102 16 (168 ) — 125,950 3,155 79,576 43,219 $ 202,462 $ 16 $ (168 ) $ — $ 202,310 $ 79,515 $ 79,576 $ 43,219 |
Summary of Amortized Cost and Estimated Fair Value of Securities By Maturity | The amortized cost and estimated fair value of the marketable securities, by maturity, are shown below (in thousands): December 31, 2016 December 31, 2015 Amortized Cost Fair Value Amortized Cost Fair Value Marketable securities: Due in one year or less $ 80,092 $ 80,027 $ 82,785 $ 82,731 Due after one year through 5 years 53,540 53,303 43,317 43,219 Due after 5 years through 10 years — — — — Due after 10 years — — — — $ 133,632 $ 133,330 $ 126,102 $ 125,950 |
Summary of Gross Unrealized Losses and Fair Value of Investments | The following table shows the gross unrealized losses and the fair value of our investments, with unrealized losses that are not deemed to be other-than-temporarily impaired aggregated by investment category and length of time that individual securities have been in a continuous unrealized loss position (in thousands): December 31, 2016 December 31, 2015 Less Than 12 Months Greater Than 12 Months Less Than 12 Months Greater Than 12 Months Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss Marketable securities: Corporate securities $ 38,027 $ (134 ) $ 401 $ (1 ) $ 25,137 $ (68 ) $ — $ — Federal agency securities 26,449 (91 ) 1,217 (1 ) 18,759 (65 ) — — Municipal securities 30,373 (81 ) 100 — 22,981 (35 ) — — $ 94,849 $ (306 ) $ 1,718 $ (2 ) $ 66,877 $ (168 ) $ — $ — |
Note 4 - Fair Value Measureme24
Note 4 - Fair Value Measurement (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Fair Value Disclosures [Abstract] | |
Summary of Investments Measured at Fair Value on Recurring Basis | Our investments measured at fair value on a recurring basis subject to the disclosure requirements of ASC 820 at December 31, 2016 were as follows (in thousands): Fair Value Measurement at Reporting Date Total Quoted Prices in active Markets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Marketable securities: Certificates of deposit $ 26,114 $ — $ 26,114 $ — Commercial paper 1,485 — 1,485 — Corporate securities 39,427 — 38,927 500 Federal agency securities 30,572 — 30,572 — Municipal securities 35,732 — 35,732 — Total assets measured at fair value $ 133,330 $ — $ 132,830 $ 500 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: Certificates of deposit $ 26,223 $ — $ 26,223 $ — Commercial paper — — — — 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 $ 125,950 $ — $ 125,950 $ — |
Summary of Additional Information about Assets Measured at Fair Value | The following table presents additional information about assets measured at fair value on a recurring basis and for which we utilize Level 3 inputs to determine fair value for the years ended December 31, 2016 and 2015 (in thousands): December 31, 2016 2015 Convertible stock Balance, beginning of period $ — $ — Change in fair value — — Purchases 500 — Balance, end of period $ 500 $ — |
Note 5 - Inventories (Tables)
Note 5 - Inventories (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Inventory Disclosure [Abstract] | |
Schedule of Components of Inventories Net of Allowances | December 31, 2016 December 31, 2015 Finished goods $ 8,408 $ 28,216 Work-in-process 6,183 7,018 Raw materials and supplies 7,152 6,481 Total inventories 21,743 41,715 Plus: non-current finished goods 4,928 — $ 26,671 $ 41,715 |
Note 6 - Property and Equipme26
Note 6 - Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Property Plant And Equipment [Abstract] | |
Components of Property and Equipment | Property and equipment are comprised of the following (in thousands): Estimated Useful Life As of December 31, (in years) 2016 2015 Computer equipment 3 — 7 $ 3,462 $ 2,798 Scientific equipment 3 — 10 12,930 9,283 Furniture 3 — 10 3,128 2,022 Manufacturing equipment 7 — 10 20,583 19,536 Leasehold improvements * 23,243 16,771 Less: accumulated depreciation and amortization (20,174 ) (12,028 ) Total fixed assets $ 43,172 $ 38,382 * The estimated useful life of the leasehold improvements is the lesser of the lease term or the estimated useful life. |
Note 7 - Commitments and Cont27
Note 7 - Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Commitments And Contingencies Disclosure [Abstract] | |
Summary of Future Minimum Commitments for Operating Leases | Years ending December 31, 2017 $ 3,113 2018 3,310 2019 3,405 2020 3,495 2021 2,526 Thereafter 14,429 Total $ 30,278 |
Summary of Aggregate Minimum Purchase Commitments | Years ending December 31, 2017 $ 7,500 2018 7,500 2019 8,410 2020 8,550 2021 4,330 Thereafter — Total $ 36,290 |
Note 8 - Equity (Tables)
Note 8 - Equity (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Equity [Abstract] | |
Summary of Share Repurchase Activity | The following table summarizes our share repurchase activity for our share repurchase program: Number of Shares Purchased Cost of Share Purchases Shares purchased at December 31, 2014 — $ — Shares purchased during 2015 560,200 $ 16,459,000 Shares purchased at December 31, 2015 560,200 $ 16,459,000 Shares purchased during 2016 843,075 16,099,000 Shares purchased at December 31, 2016 1,403,275 $ 32,558,000 |
Note 9 - Stock-based Compensa29
Note 9 - Stock-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Amounts Recognized in Condensed Consolidated Statements of Income and Comprehensive income with Respect to Stock-Based Compensation Plans | 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, 2016 2015 2014 (As Revised) Research and development $ 3,931 $ 2,133 $ 5,498 General and administrative 17,658 19,749 9,791 Total cost of stock-based compensation $ 21,589 $ 21,882 $ 15,289 |
Summary of Stock Option Activity | The following table summarizes stock option activity during the year ended December 31, 2016: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (in Aggregate Intrinsic Value (in millions) Outstanding as of December 31, 2013 8,994,978 $ 1.06 Granted 3,397,198 $ 4.86 Cancelled (1,068,224 ) $ 2.86 Exercised (3,616,790 ) $ 1.15 Outstanding as of December 31, 2014 7,707,162 $ 2.90 Granted 1,733,671 $ 14.57 Cancelled (695,061 ) $ 7.71 Exercised (1,607,683 ) $ 2.48 Outstanding as of December 31, 2015 7,138,089 $ 7.57 Granted 2,337,043 $ 14.86 Cancelled (1,536,538 ) $ 18.67 Exercised (637,721 ) $ 5.96 $ 7.0 Outstanding as of December 31, 2016 7,300,873 $ 12.36 7.3 $ 18.7 Vested and exercisable as of December 31, 2016 4,474,906 $ 9.05 6.4 $ 18.0 |
Summary of Weighted-Average Assumptions used to Estimate Fair Value of Employee Stock Options | The weighted-average assumptions used to estimate the fair value of employee stock options granted during the periods presented are as follows: 2016 2015 2014 Expected volatility 63.3 % 69.9 % 69.3 % Risk-free interest rate 1.6 % 1.9 % 1.7 % Expected term (in years) 7.0 7.0 6.0 Expected dividend yield 0.0 % 0.0 % 0.0 % |
Note 10 - Income Taxes (Tables)
Note 10 - Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |
Income Tax Expense | Years Ended December 31, 2016 2015 2014 (As Revised) (As Revised) Current income taxes: Federal $ 5,916 $ 31,383 $ 21,949 State and local 554 6,473 3,794 Total current income tax 6,470 37,856 25,743 Deferred income taxes: Federal (7,762 ) (3,759 ) 465 State and local 2,126 (1,156 ) (1,119 ) Total deferred income tax (5,636 ) (4,915 ) (654 ) Income tax expense $ 834 $ 32,941 $ 25,089 |
Deferred Tax Assets | 2016 2015 (As Revised) Deferred income tax assets: NOLs and credits $ 27,046 $ 26,910 Start-up expenditures 2,604 2,896 Stock-based compensation 11,727 8,578 Allowances 1,264 1,581 Expenses currently not deductible for tax purposes 10,652 6,129 Other 1,963 1,142 Gross deferred tax assets 55,256 47,236 Deferred income tax asset valuation allowance (23,508 ) (20,203 ) Deferred income tax assets 31,748 27,033 Deferred income tax liabilities: Federal impact of state taxes (1,073 ) (1,817 ) Property and equipment (6,246 ) (6,189 ) Prepaid expenses (1,186 ) (1,420 ) Net deferred income tax assets $ 23,243 $ 17,607 |
Effective Tax Rate Reconciliation | 2016 2015 2014 (As Revised) (As Revised) 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 (0.1 )% 2.3 % 4.1 % Non-deductible litigation expense 3.4 % 3.5 % 3.2 % Non-deductible and includible items 7.5 % 0.7 % 0.7 % Non-deductible lobbying expense 8.3 % — — Research and other credits (63.5 )% (5.4 )% (3.6 )% Uncertain tax positions 4.2 % 2.7 % 1.9 % Domestic manufacturing deduction (14.6 )% (3.0 )% (0.3 )% Stock based compensation 5.1 % 0.4 % 0.1 % Tax exempt interest income (1.5 )% — — Other 0.6 % — — Change in valuation allowance 25.5 % (0.1 )% — Total provision for income taxes 9.9 % 36.1 % 41.1 % |
Beginning and Ending Amounts of Unrecognized Tax Benefits | Years Ended December 31, 2016 2015 (As Revised) Beginning balance $ 8,920 $ 5,323 Additions based on current year's tax positions 758 3,837 Additions based on prior year's tax positions 122 (240 ) Ending balance $ 9,800 $ 8,920 |
Note-11 - Net Income Per Share
Note-11 - Net Income Per Share (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Earnings Per Share [Abstract] | |
Schedule of Computation of Basic and Diluted Net Income (Loss) Per Common Share | Years Ended December 31, 2016 2015 2014 (As Revised) (As Revised) Historical net income per share - Basic Numerator: Net income $ 7,590 $ 58,053 $ 36,054 Denominator: Weighted average number of common shares outstanding 71,618,793 71,592,581 68,759,070 Basic net income per common share $ 0.11 $ 0.81 $ 0.52 Historical net income per share - Diluted Numerator: Net income $ 7,590 $ 58,053 $ 36,054 Denominator: Weighted average number of common shares outstanding 71,618,793 71,592,581 68,759,070 Effect of dilutive stock options 2,527,125 4,115,070 4,576,062 Weighted average number of common shares outstanding 74,145,918 75,707,651 73,335,132 Diluted net income per common share $ 0.10 $ 0.77 $ 0.49 |
Note 12 - Product Lines, Conc32
Note 12 - Product Lines, Concentration of Credit Risk and Significant Customers (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Segment Reporting [Abstract] | |
Summary of Net Revenue by Product Line and Percentages | Net Revenue by Product Line Years Ended December 31, 2016 2015 2014 (As Revised) (As Revised) Subsys $ 242,275 $ 329,040 $ 216,497 Dronabinol SG Capsule — 1,283 2,595 Total net revenue $ 242,275 $ 330,323 $ 219,092 |
Percentage of Revenue by Route to Market | Percent of Revenue by Route to Market Years Ended December 31, 2016 2015 2014 Pharmaceutical wholesalers 67 % 95 % 99 % Specialty pharmaceutical retailers 33 % 5 % 0 % Generic pharmaceutical distributors 0 % 0 % 1 % 100 % 100 % 100 % |
Note 13 - Supplemental Financ33
Note 13 - Supplemental Financial Information (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Valuation And Qualifying Accounts [Abstract] | |
Allowances for Accounts Receivables | Balance at Beginning of Year Charged to Costs and Expenses Utilization Balance at End of Year Allowance for doubtful accounts: Year ended December 31, 2016 $ 811 $ (96 ) $ (30 ) $ 685 Year ended December 31, 2015 $ 398 $ 413 $ — $ 811 Year ended December 31, 2014 $ — $ 398 $ — $ 398 Allowance for sales wholesaler discounts, prompt pay discounts, stocking allowances, and chargebacks: Year ended December 31, 2016 $ 7,556 $ 27,968 $ (30,065 ) $ 5,459 Year ended December 31, 2015 (As Revised) $ 5,418 $ 38,036 $ (35,898 ) $ 7,556 Year ended December 31, 2014 (As Revised) $ 2,748 $ 22,395 $ (19,725 ) $ 5,418 |
Note 14 - Quarterly Results o34
Note 14 - Quarterly Results of Operations (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Quarterly Financial Information Disclosure [Abstract] | |
Schedule of Quarterly Results of Operations | Quarter Ended 12/31/16 9/30/16 6/30/16 3/31/16 Net revenue - as originally reported $ 54,860 $ 55,180 $ 67,121 $ 61,962 Adjustment - prior period underestimation of sales allowances — 2,593 2,100 (1,541 ) Net revenue (As Restated) $ 54,860 $ 57,773 $ 69,221 $ 60,421 Gross profit (1) - as originally reported $ 45,055 $ 50,503 $ 60,848 $ 57,324 Adjustment - prior period underestimation of sales allowances — 2,593 2,100 (1,541 ) Gross profit (1) (As Restated) $ 45,055 $ 53,096 $ 62,948 $ 55,783 Total operating expenses - as originally reported $ 48,688 $ 50,831 $ 56,504 $ 55,033 Adjustment - prior period stock option modification — — — (1,500 ) Total operating expenses (As Restated) $ 48,688 $ 50,831 $ 56,504 $ 53,533 Income (loss) before income taxes - as originally reported $ (3,341 ) $ (47 ) $ 4,595 $ 2,565 Adjustment — 2,593 2,100 (41 ) Income before income taxes (As Restated) $ (3,341 ) $ 2,546 $ 6,695 $ 2,524 Income tax expense (benefit) - as originally reported $ 311 $ (237 ) $ 240 $ 131 Adjustment — (142 ) 428 103 Income tax expense (benefit) (As Restated) $ 311 $ (379 ) $ 668 $ 234 Net income (loss) (2) - as originally reported $ (3,652 ) $ 190 $ 4,355 $ 2,434 Adjustment — 2,735 1,672 (144 ) Net income (loss) (2) (As Restated) $ (3,652 ) $ 2,925 $ 6,027 $ 2,290 Total comprehensive income (loss) - as originally reported $ (3,880 ) $ 32 $ 4,425 $ 2,600 Adjustment — 2,735 1,672 (144 ) Total comprehensive income (loss) (As Restated) $ (3,880 ) $ 2,767 $ 6,097 $ 2,456 Net income (loss) per common share: Basic - as originally reported $ (0.05 ) $ — $ 0.06 $ 0.03 Adjustment — 0.04 0.02 0.00 Basic (As Restated) $ (0.05 ) $ 0.04 $ 0.08 $ 0.03 Diluted - as originally reported $ (0.05 ) $ — $ 0.06 $ 0.03 Adjustment — 0.04 0.02 0.00 Diluted (As Restated) $ (0.05 ) $ 0.04 $ 0.08 $ 0.03 Quarter Ended 12/31/15 9/30/15 6/30/15 3/31/15 Net revenue - as originally reported $ 91,135 $ 91,259 $ 77,633 $ 70,770 Adjustment - prior period underestimation of sales allowances 2,779 (2,742 ) 2,567 (3,078 ) Net revenue (As Restated) $ 93,914 $ 88,517 $ 80,200 $ 67,692 Gross profit - as originally reported $ 84,668 $ 83,552 $ 69,328 $ 64,395 Adjustment - prior period underestimation of sales allowances 2,779 (2,742 ) 2,567 (3,078 ) Gross profit (As Restated) $ 87,447 $ 80,810 $ 71,895 $ 61,317 Total operating expenses - as originally reported $ 54,948 $ 44,431 $ 57,370 $ 52,764 Adjustment - prior period stock option modification 1,500 — — — Total operating expenses (As Restated) $ 56,448 $ 44,431 $ 57,370 $ 52,764 Income before income taxes - as originally reported $ 29,907 $ 39,212 $ 12,093 $ 11,756 Adjustment 1,279 (2,742 ) 2,567 (3,078 ) Income before income taxes (As Restated) $ 31,186 $ 36,470 $ 14,660 $ 8,678 Income tax expense - as originally reported $ 12,896 $ 13,084 $ 4,779 $ 3,733 Adjustment 147 (1,244 ) 468 (922 ) Income tax expense (As Restated) $ 13,043 $ 11,840 $ 5,247 $ 2,811 Net income - as originally reported $ 17,011 $ 26,128 $ 7,314 $ 8,023 Adjustment 1,132 (1,498 ) 2,099 (2,156 ) Net income (As Restated) $ 18,143 $ 24,630 $ 9,413 $ 5,867 Total comprehensive income - as originally reported $ 16,826 $ 26,178 $ 7,293 $ 8,051 Adjustment 1,132 (1,498 ) 2,099 (2,156 ) Total comprehensive income (As Restated) $ 17,958 $ 24,680 $ 9,392 $ 5,895 Net income per common share: Basic - as originally reported $ 0.24 $ 0.36 $ 0.10 $ 0.11 Adjustment 0.01 (0.02 ) 0.03 (0.03 ) Basic (As Restated) $ 0.25 $ 0.34 $ 0.13 $ 0.08 Diluted - as originally reported $ 0.22 $ 0.34 $ 0.10 $ 0.11 Adjustment 0.02 (0.02 ) 0.02 (0.03 ) Diluted (As Restated) $ 0.24 $ 0.32 $ 0.12 $ 0.08 (1) The fourth quarter of 2016 includes an allowance of $5,800,000 for excess and obsolete SUBSYS® inventory. (2) The fourth quarter of 2016 includes charges related to litigation award and settlements of $3,900,000. |
Note 1 - Nature of Business (De
Note 1 - Nature of Business (Details Textual) | 12 Months Ended |
Dec. 31, 2016ProductLine | |
SUBSYS [Member] | |
Nature Of Business [Line Items] | |
Number of Product Lines | 1 |
SYNDROS [Member] | |
Nature Of Business [Line Items] | |
Number of Product Lines | 1 |
Note 2 - Significant Accounti36
Note 2 - Significant Accounting Policies (Details Textual) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2016USD ($) | Sep. 30, 2016USD ($) | Jun. 30, 2016USD ($) | Mar. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Sep. 30, 2015USD ($) | Jun. 30, 2015USD ($) | Mar. 31, 2015USD ($) | Dec. 31, 2016USD ($)Segment | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | |
Significant Accounting Policies [Line Items] | |||||||||||
Total operating expenses | $ 48,688,000 | $ 50,831,000 | $ 56,504,000 | $ 53,533,000 | $ 56,448,000 | $ 44,431,000 | $ 57,370,000 | $ 52,764,000 | $ 209,556,000 | $ 211,013,000 | $ 135,524,000 |
Realized Investment Gains (Losses) | 0 | 0 | 0 | ||||||||
Reclassifications on available-for-sale securities | 0 | ||||||||||
Investment Owned, at Fair Value | 236,676,000 | $ 202,310,000 | 236,676,000 | 202,310,000 | |||||||
Advertising Expense | 1,572,000 | 1,166,000 | 800,000 | ||||||||
Legal Fees | $ 22,840,000 | 19,448,000 | $ 16,926,000 | ||||||||
Number of reportable segment | Segment | 1 | ||||||||||
Minimum [Member] | |||||||||||
Significant Accounting Policies [Line Items] | |||||||||||
Stock-based compensation award, vesting period | 3 years | ||||||||||
Maximum [Member] | |||||||||||
Significant Accounting Policies [Line Items] | |||||||||||
Stock-based compensation award, vesting period | 4 years | ||||||||||
Cash and Cash Equivalents [Member] | |||||||||||
Significant Accounting Policies [Line Items] | |||||||||||
Investment Owned, at Fair Value | 1,296,000 | $ 1,296,000 | |||||||||
Short-term Investments [Member] | |||||||||||
Significant Accounting Policies [Line Items] | |||||||||||
Investment Owned, at Fair Value | 78,238,000 | 78,238,000 | |||||||||
Other Long-term Investments [Member] | |||||||||||
Significant Accounting Policies [Line Items] | |||||||||||
Investment Owned, at Fair Value | $ 53,796,000 | $ 53,796,000 | |||||||||
SUBSYS [Member] | |||||||||||
Significant Accounting Policies [Line Items] | |||||||||||
Product Return, Period Prior to Expiration | 6 months | ||||||||||
Product Return, Period After Expiration | 12 months | ||||||||||
Shelf Life of Product from Date of Manufacture | 36 months | ||||||||||
Cash Discount, Percent | 2.00% | 2.00% | |||||||||
Restatement Adjustment | |||||||||||
Significant Accounting Policies [Line Items] | |||||||||||
Total operating expenses | $ 1,500,000 |
Note 2 - Significant Accounti37
Note 2 - Significant Accounting Policies - Adjusted Consolidated Balance Sheet (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 |
Error Corrections And Prior Period Adjustments Restatement [Line Items] | ||||
Deferred income tax assets, net | $ 23,243 | $ 17,607 | ||
Total assets | 356,136 | 351,285 | ||
Accounts payable and accrued expenses | 27,359 | 35,611 | ||
Accrued sales allowances | 28,955 | 35,033 | ||
Total current liabilities | 78,614 | 90,436 | ||
Uncertain income tax position | 7,933 | 8,544 | ||
Total liabilities | 86,547 | 98,980 | ||
Additional paid in capital | 256,529 | 246,685 | $ 215,507 | |
Retained earnings | 12,664 | 5,074 | (52,979) | |
Total stockholders' equity | 269,589 | 252,305 | 163,190 | $ 79,477 |
Total liabilities and stockholders' equity | $ 356,136 | 351,285 | 215,635 | |
Scenario, Previously Reported | ||||
Error Corrections And Prior Period Adjustments Restatement [Line Items] | ||||
Deferred income tax assets, net | 16,331 | |||
Total assets | 350,009 | |||
Accounts payable and accrued expenses | 36,354 | |||
Accrued sales allowances | 31,526 | |||
Total current liabilities | 87,672 | |||
Uncertain income tax position | 8,635 | |||
Total liabilities | 96,307 | |||
Additional paid in capital | 245,736 | 216,061 | ||
Retained earnings | 7,420 | (51,056) | ||
Total stockholders' equity | 253,702 | 165,667 | ||
Total liabilities and stockholders' equity | 350,009 | 215,121 | ||
Restatement Adjustment | ||||
Error Corrections And Prior Period Adjustments Restatement [Line Items] | ||||
Deferred income tax assets, net | 1,276 | |||
Total assets | 1,276 | |||
Accounts payable and accrued expenses | (743) | |||
Accrued sales allowances | 3,507 | |||
Total current liabilities | 2,764 | |||
Uncertain income tax position | (91) | |||
Total liabilities | 2,673 | |||
Additional paid in capital | 949 | (554) | ||
Retained earnings | (2,346) | (1,923) | ||
Total stockholders' equity | (1,397) | (2,477) | ||
Total liabilities and stockholders' equity | $ 1,276 | $ 514 |
Note 2 - Significant Accounti38
Note 2 - Significant Accounting Policies - Adjusted Consolidated Statement of Comprehensive Income (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |||||||||||||
Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |||||
Error Corrections And Prior Period Adjustments Restatement [Line Items] | |||||||||||||||
Net revenue | $ 54,860,000 | $ 57,773,000 | $ 69,221,000 | $ 60,421,000 | $ 93,914,000 | $ 88,517,000 | $ 80,200,000 | $ 67,692,000 | $ 242,275,000 | $ 330,323,000 | $ 219,092,000 | ||||
Gross profit | 45,055,000 | [1] | 53,096,000 | [1] | 62,948,000 | [1] | 55,783,000 | [1] | 87,447,000 | 80,810,000 | 71,895,000 | 61,317,000 | 216,882,000 | 301,469,000 | 196,514,000 |
Operating expenses: | |||||||||||||||
Research and development | 73,913,000 | 56,781,000 | 33,136,000 | ||||||||||||
Total operating expenses | 48,688,000 | 50,831,000 | 56,504,000 | 53,533,000 | 56,448,000 | 44,431,000 | 57,370,000 | 52,764,000 | 209,556,000 | 211,013,000 | 135,524,000 | ||||
Operating income | 7,326,000 | 90,456,000 | 60,990,000 | ||||||||||||
Income before income taxes | (3,341,000) | 2,546,000 | 6,695,000 | 2,524,000 | 31,186,000 | 36,470,000 | 14,660,000 | 8,678,000 | 8,424,000 | 90,994,000 | 61,143,000 | ||||
Less: income tax expense | 311,000 | (379,000) | 668,000 | 234,000 | 13,043,000 | 11,840,000 | 5,247,000 | 2,811,000 | 834,000 | 32,941,000 | 25,089,000 | ||||
Net income | (3,652,000) | [2] | 2,925,000 | [2] | 6,027,000 | [2] | 2,290,000 | [2] | 18,143,000 | 24,630,000 | 9,413,000 | 5,867,000 | 7,590,000 | 58,053,000 | 36,054,000 |
Total comprehensive income | $ (3,880,000) | $ 2,767,000 | $ 6,097,000 | $ 2,456,000 | $ 17,958,000 | $ 24,680,000 | $ 9,392,000 | $ 5,895,000 | $ 7,440,000 | $ 57,925,000 | $ 36,030,000 | ||||
Net income per common share: | |||||||||||||||
Basic | $ (0.05) | $ 0.04 | $ 0.08 | $ 0.03 | $ 0.25 | $ 0.34 | $ 0.13 | $ 0.08 | $ 0.11 | $ 0.81 | $ 0.52 | ||||
Diluted | $ (0.05) | $ 0.04 | $ 0.08 | $ 0.03 | $ 0.24 | $ 0.32 | $ 0.12 | $ 0.08 | $ 0.10 | $ 0.77 | $ 0.49 | ||||
Scenario, Previously Reported | |||||||||||||||
Error Corrections And Prior Period Adjustments Restatement [Line Items] | |||||||||||||||
Net revenue | $ 55,180,000 | $ 67,121,000 | $ 61,962,000 | $ 91,135,000 | $ 91,259,000 | $ 77,633,000 | $ 70,770,000 | $ 330,797,000 | $ 222,125,000 | ||||||
Gross profit | 50,503,000 | [1] | 60,848,000 | [1] | 57,324,000 | [1] | 84,668,000 | 83,552,000 | 69,328,000 | 64,395,000 | 301,943,000 | 199,547,000 | |||
Operating expenses: | |||||||||||||||
Research and development | 55,281,000 | ||||||||||||||
Total operating expenses | 50,831,000 | 56,504,000 | 55,033,000 | 54,948,000 | 44,431,000 | 57,370,000 | 52,764,000 | 209,513,000 | |||||||
Operating income | 92,430,000 | 64,023,000 | |||||||||||||
Income before income taxes | (47,000) | 4,595,000 | 2,565,000 | 29,907,000 | 39,212,000 | 12,093,000 | 11,756,000 | 92,968,000 | 64,176,000 | ||||||
Less: income tax expense | (237,000) | 240,000 | 131,000 | 12,896,000 | 13,084,000 | 4,779,000 | 3,733,000 | 34,492,000 | 26,199,000 | ||||||
Net income | 190,000 | [2] | 4,355,000 | [2] | 2,434,000 | [2] | 17,011,000 | 26,128,000 | 7,314,000 | 8,023,000 | 58,476,000 | 37,977,000 | |||
Total comprehensive income | 32,000 | $ 4,425,000 | $ 2,600,000 | $ 16,826,000 | $ 26,178,000 | $ 7,293,000 | $ 8,051,000 | $ 58,348,000 | $ 37,953,000 | ||||||
Net income per common share: | |||||||||||||||
Basic | $ 0.06 | $ 0.03 | $ 0.24 | $ 0.36 | $ 0.10 | $ 0.11 | $ 0.82 | $ 0.55 | |||||||
Diluted | $ 0.06 | $ 0.03 | $ 0.22 | $ 0.34 | $ 0.10 | $ 0.11 | $ 0.77 | $ 0.52 | |||||||
Restatement Adjustment | |||||||||||||||
Error Corrections And Prior Period Adjustments Restatement [Line Items] | |||||||||||||||
Net revenue | $ (474,000) | $ (3,033,000) | |||||||||||||
Gross profit | (474,000) | (3,033,000) | |||||||||||||
Operating expenses: | |||||||||||||||
Research and development | 1,500,000 | ||||||||||||||
Total operating expenses | 1,500,000 | ||||||||||||||
Operating income | (1,974,000) | (3,033,000) | |||||||||||||
Income before income taxes | 2,593,000 | $ 2,100,000 | $ (41,000) | $ 1,279,000 | $ (2,742,000) | $ 2,567,000 | $ (3,078,000) | (1,974,000) | (3,033,000) | ||||||
Less: income tax expense | (142,000) | 428,000 | 103,000 | 147,000 | (1,244,000) | 468,000 | (922,000) | (1,551,000) | (1,110,000) | ||||||
Net income | 2,735,000 | 1,672,000 | (144,000) | 1,132,000 | (1,498,000) | 2,099,000 | (2,156,000) | (423,000) | (1,923,000) | ||||||
Total comprehensive income | $ 2,735,000 | $ 1,672,000 | $ (144,000) | $ 1,132,000 | $ (1,498,000) | $ 2,099,000 | $ (2,156,000) | $ (423,000) | $ (1,923,000) | ||||||
Net income per common share: | |||||||||||||||
Basic | $ 0.04 | $ 0.02 | $ 0 | $ 0.01 | $ (0.02) | $ 0.03 | $ (0.03) | $ (0.01) | $ (0.03) | ||||||
Diluted | $ 0.04 | $ 0.02 | $ 0 | $ 0.02 | $ (0.02) | $ 0.02 | $ (0.03) | $ 0 | $ (0.03) | ||||||
[1] | The fourth quarter of 2016 includes an allowance of $5,800,000 for excess and obsolete SUBSYS® inventory. | ||||||||||||||
[2] | The fourth quarter of 2016 includes charges related to litigation award and settlements of $3,900,000. |
Note 2 - Significant Accounti39
Note 2 - Significant Accounting Policies - Adjusted Consolidated Statement of Cash Flow (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Cash flows from operating activities: | |||
Stock-based compensation | $ 21,589 | $ 21,882 | $ 15,289 |
Deferred income tax benefit | (5,636) | (4,914) | (655) |
Excess tax benefits on stock options and awards | 1,729 | (13,596) | (21,449) |
Prepaid expenses and other current assets | (1,721) | 1,345 | (2,967) |
Accounts payable, accrued expenses and other current liabilities | (18,487) | 50,708 | 52,813 |
Net cash provided by operating activities | 58,904 | 102,278 | 50,585 |
Cash flows from financing activities: | |||
Excess tax benefits on stock options and awards | (1,729) | 13,596 | 21,449 |
Net cash provided by financing activities | $ (11,745) | 9,308 | 32,394 |
Scenario, Previously Reported | |||
Cash flows from operating activities: | |||
Stock-based compensation | 20,382 | ||
Deferred income tax benefit | (4,118) | (175) | |
Excess tax benefits on stock options and awards | (13,593) | (22,003) | |
Prepaid expenses and other current assets | 1,311 | (2,933) | |
Accounts payable, accrued expenses and other current liabilities | 51,023 | 50,376 | |
Net cash provided by operating activities | 102,281 | 50,031 | |
Cash flows from financing activities: | |||
Excess tax benefits on stock options and awards | 13,593 | 22,003 | |
Net cash provided by financing activities | 9,305 | 32,948 | |
Restatement Adjustment | |||
Cash flows from operating activities: | |||
Stock-based compensation | 1,500 | ||
Deferred income tax benefit | (796) | (480) | |
Excess tax benefits on stock options and awards | (3) | 554 | |
Prepaid expenses and other current assets | 34 | (34) | |
Accounts payable, accrued expenses and other current liabilities | (315) | 2,437 | |
Net cash provided by operating activities | (3) | 554 | |
Cash flows from financing activities: | |||
Excess tax benefits on stock options and awards | 3 | (554) | |
Net cash provided by financing activities | $ 3 | $ (554) |
Note 3 - Short-term and Long-40
Note 3 - Short-term and Long-term Investments - Summary of Investments (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 |
Schedule Of Investments [Line Items] | ||||
Cost | $ 236,978 | $ 202,462 | ||
Unrealized Gains | 6 | 16 | ||
Unrealized Losses | (308) | (168) | ||
Fair Value | 236,676 | 202,310 | ||
Cash and Cash Equivalents | 104,642 | 79,515 | $ 58,106 | $ 45,382 |
Short-term Investments | 78,238 | 79,576 | ||
Long-term Investments | 53,796 | 43,219 | ||
Cash [Member] | ||||
Schedule Of Investments [Line Items] | ||||
Cost | 49,331 | 55,987 | ||
Fair Value | 49,331 | 55,987 | ||
Cash and Cash Equivalents | 49,331 | 55,987 | ||
Money Market Securities [Member] | ||||
Schedule Of Investments [Line Items] | ||||
Cost | 54,015 | 20,373 | ||
Fair Value | 54,015 | 20,373 | ||
Cash and Cash Equivalents | 54,015 | 20,373 | ||
Certificates of Deposit [Member] | ||||
Schedule Of Investments [Line Items] | ||||
Cost | 26,114 | 26,223 | ||
Fair Value | 26,114 | 26,223 | ||
Short-term Investments | 13,855 | 16,637 | ||
Long-term Investments | 12,259 | 9,586 | ||
Commercial Paper [Member] | ||||
Schedule Of Investments [Line Items] | ||||
Cost | 1,485 | |||
Fair Value | 1,485 | |||
Short-term Investments | 1,485 | |||
Corporate Securities [Member] | ||||
Schedule Of Investments [Line Items] | ||||
Cost | 39,562 | 27,186 | ||
Unrealized Losses | (135) | (68) | ||
Fair Value | 39,427 | 27,118 | ||
Cash and Cash Equivalents | 500 | 1,621 | ||
Short-term Investments | 25,681 | 19,181 | ||
Long-term Investments | 13,246 | 6,316 | ||
Federal Agency Securities [Member] | ||||
Schedule Of Investments [Line Items] | ||||
Cost | 30,660 | 18,823 | ||
Unrealized Gains | 4 | |||
Unrealized Losses | (92) | (65) | ||
Fair Value | 30,572 | 18,758 | ||
Short-term Investments | 10,854 | 10,129 | ||
Long-term Investments | 19,718 | 8,629 | ||
Municipal Securities [Member] | ||||
Schedule Of Investments [Line Items] | ||||
Cost | 35,811 | 53,870 | ||
Unrealized Gains | 2 | 16 | ||
Unrealized Losses | (81) | (35) | ||
Fair Value | 35,732 | 53,851 | ||
Cash and Cash Equivalents | 796 | 1,534 | ||
Short-term Investments | 26,363 | 33,629 | ||
Long-term Investments | 8,573 | 18,688 | ||
Marketable Securities [Member] | ||||
Schedule Of Investments [Line Items] | ||||
Cost | 133,632 | 126,102 | ||
Unrealized Gains | 6 | 16 | ||
Unrealized Losses | (308) | (168) | ||
Fair Value | 133,330 | 125,950 | ||
Cash and Cash Equivalents | 1,296 | 3,155 | ||
Short-term Investments | 78,238 | 79,576 | ||
Long-term Investments | $ 53,796 | $ 43,219 |
Note 3 - Short-term and Long-41
Note 3 - Short-term and Long-term Investments - Summary of Amortized Cost and Estimated Fair Value of Securities By Maturity (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Marketable securities: | ||
Due in one year or less, Amortized Cost | $ 80,092 | $ 82,785 |
Due after one year through 5 years, Amortized Cost | 53,540 | 43,317 |
Total, Amortized Cost | 133,632 | 126,102 |
Due in one year or less, Fair Value | 80,027 | 82,731 |
Due after one year through 5 years, Fair Value | 53,303 | 43,219 |
Total, Fair value | $ 133,330 | $ 125,950 |
Note 3 - Short-term and Long-42
Note 3 - Short-term and Long-term Investments - Summary of Gross Unrealized Losses and Fair Value of Investments (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Marketable securities: | ||
Less Than 12 Months Fair Value | $ 94,849 | $ 66,877 |
Less Than 12 Months Unrealized Loss | (306) | (168) |
Greater Than 12 Months Fair Value | 1,718 | |
Greater Than 12 Months Unrealized Loss | (2) | |
Corporate Bond Securities [Member] | ||
Marketable securities: | ||
Less Than 12 Months Fair Value | 38,027 | 25,137 |
Less Than 12 Months Unrealized Loss | (134) | (68) |
Greater Than 12 Months Fair Value | 401 | |
Greater Than 12 Months Unrealized Loss | (1) | |
Federal Agency Securities [Member] | ||
Marketable securities: | ||
Less Than 12 Months Fair Value | 26,449 | 18,759 |
Less Than 12 Months Unrealized Loss | (91) | (65) |
Greater Than 12 Months Fair Value | 1,217 | |
Greater Than 12 Months Unrealized Loss | (1) | |
Municipal Securities [Member] | ||
Marketable securities: | ||
Less Than 12 Months Fair Value | 30,373 | 22,981 |
Less Than 12 Months Unrealized Loss | (81) | $ (35) |
Greater Than 12 Months Fair Value | $ 100 |
Note 4 - Fair Value Measureme43
Note 4 - Fair Value Measurement - Summary of Investments Measured at Fair Value on Recurring Basis (Detail) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | $ 133,330 | $ 125,950 |
Significant Other Observable Inputs (Level 2) [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 132,830 | 125,950 |
Significant Unobservable Inputs (Level 3) [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 500 | |
Certificates of Deposit [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 26,114 | 26,223 |
Certificates of Deposit [Member] | Significant Other Observable Inputs (Level 2) [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 26,114 | 26,223 |
Commercial Paper [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 1,485 | |
Commercial Paper [Member] | Significant Other Observable Inputs (Level 2) [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 1,485 | |
Corporate Securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 39,427 | 27,118 |
Corporate Securities [Member] | Significant Other Observable Inputs (Level 2) [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 38,927 | 27,118 |
Corporate Securities [Member] | Significant Unobservable Inputs (Level 3) [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 500 | |
Federal Agency Securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 30,572 | 18,758 |
Federal Agency Securities [Member] | Significant Other Observable Inputs (Level 2) [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 30,572 | 18,758 |
Municipal Securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 35,732 | 53,851 |
Municipal Securities [Member] | Significant Other Observable Inputs (Level 2) [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | $ 35,732 | $ 53,851 |
Note 4 - Fair Value Measureme44
Note 4 - Fair Value Measurement - Summary of Additional Information about Assets Measured at Fair Value (Detail) $ in Thousands | 12 Months Ended |
Dec. 31, 2016USD ($) | |
Fair Value Disclosures [Abstract] | |
Purchases | $ 500 |
Balance, end of period | $ 500 |
Note 5 - Inventories - Schedule
Note 5 - Inventories - Schedule of Components of Inventories Net of Allowances (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Inventory Disclosure [Abstract] | ||
Finished goods | $ 8,408 | $ 28,216 |
Work-in-process | 6,183 | 7,018 |
Raw materials and supplies | 7,152 | 6,481 |
Total inventories | 21,743 | 41,715 |
Plus: non-current finished goods | 4,928 | |
Inventories, net | $ 26,671 | $ 41,715 |
Note 5 - Inventories (Details T
Note 5 - Inventories (Details Textual) - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 |
Inventory Disclosure [Abstract] | ||
Inventory Valuation Reserves | $ 6,793,000 | $ 100,000 |
Note 6 - Property and Equipme47
Note 6 - Property and Equipment - Components of Property and Equipment (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | ||
Property Plant And Equipment [Line Items] | |||
Less: accumulated depreciation and amortization | $ (20,174) | $ (12,028) | |
Total fixed assets | 43,172 | 38,382 | |
Computer Equipment [Member] | |||
Property Plant And Equipment [Line Items] | |||
Property, Plant and Equipment, gross | $ 3,462 | 2,798 | |
Computer Equipment [Member] | Minimum [Member] | |||
Property Plant And Equipment [Line Items] | |||
Estimated Useful Life | 3 years | ||
Computer Equipment [Member] | Maximum [Member] | |||
Property Plant And Equipment [Line Items] | |||
Estimated Useful Life | 7 years | ||
Equipment [Member] | |||
Property Plant And Equipment [Line Items] | |||
Property, Plant and Equipment, gross | $ 12,930 | 9,283 | |
Equipment [Member] | Minimum [Member] | |||
Property Plant And Equipment [Line Items] | |||
Estimated Useful Life | 3 years | ||
Equipment [Member] | Maximum [Member] | |||
Property Plant And Equipment [Line Items] | |||
Estimated Useful Life | 10 years | ||
Furniture and Fixtures [Member] | |||
Property Plant And Equipment [Line Items] | |||
Property, Plant and Equipment, gross | $ 3,128 | 2,022 | |
Furniture and Fixtures [Member] | Minimum [Member] | |||
Property Plant And Equipment [Line Items] | |||
Estimated Useful Life | 3 years | ||
Furniture and Fixtures [Member] | Maximum [Member] | |||
Property Plant And Equipment [Line Items] | |||
Estimated Useful Life | 10 years | ||
Manufacturing Equipment [Member] | |||
Property Plant And Equipment [Line Items] | |||
Property, Plant and Equipment, gross | $ 20,583 | 19,536 | |
Manufacturing Equipment [Member] | Minimum [Member] | |||
Property Plant And Equipment [Line Items] | |||
Estimated Useful Life | 7 years | ||
Manufacturing Equipment [Member] | Maximum [Member] | |||
Property Plant And Equipment [Line Items] | |||
Estimated Useful Life | 10 years | ||
Leasehold Improvements [Member] | |||
Property Plant And Equipment [Line Items] | |||
Estimated Useful Life | [1] | ||
Property, Plant and Equipment, gross | [1] | $ 23,243 | $ 16,771 |
[1] | The estimated useful life of the leasehold improvements is the lesser of the lease term or the estimated useful life. |
Note 6 - Property and Equipme48
Note 6 - Property and Equipment (Details Textual) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Property Plant And Equipment [Abstract] | |||
Depreciation, Depletion and Amortization | $ 6,249,000 | $ 5,291,000 | $ 2,500,000 |
Construction in progress | $ 6,857,000 | $ 7,391,000 |
Note 7 - Commitments and Cont49
Note 7 - Commitments and Contingencies - Summary of Future Minimum Commitments for Operating Leases (Details) $ in Thousands | Dec. 31, 2016USD ($) |
Years ending December 31, | |
2,017 | $ 3,113 |
2,018 | 3,310 |
2,019 | 3,405 |
2,020 | 3,495 |
2,021 | 2,526 |
Thereafter | 14,429 |
Total | $ 30,278 |
Note 7 - Commitments and Cont50
Note 7 - Commitments and Contingencies (Details Textual) - USD ($) | Jul. 14, 2016 | Nov. 01, 2015 | Oct. 02, 2015 | Jun. 23, 2015 | Jun. 08, 2015 | Oct. 30, 2015 | Dec. 31, 2016 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Jun. 30, 2016 |
Commitments And Contingencies [Line Items] | |||||||||||
Deferred rent | $ 3,003,000 | $ 3,003,000 | $ 3,160,000 | ||||||||
Operating Leases, Rent Expense, Net | 2,757,000 | 2,445,000 | $ 1,698,000 | ||||||||
Purchase Obligation | 36,290,000 | $ 36,290,000 | |||||||||
Defined Contribution Plan, Employer Matching Contribution, Percent of Employees' Gross Pay | 6.00% | ||||||||||
Defined Contribution Plan, Employer Matching Contribution, Percent of Match | 50.00% | ||||||||||
Defined contribution plan, employer matching contribution plan expenses | $ 730,000 | 670,000 | |||||||||
Litigation Settlement, Expense | 3,900,000 | 3,900,000 | 10,616,000 | ||||||||
Anti-Kickback Statute Litigation [Member] | Settled Litigation [Member] | |||||||||||
Commitments And Contingencies [Line Items] | |||||||||||
Payments In Question | $ 83,000 | ||||||||||
Oregon Department of Justice [Member] | Settled Litigation [Member] | |||||||||||
Commitments And Contingencies [Line Items] | |||||||||||
Litigation Settlement, Amount | $ 1,100,000 | ||||||||||
State of New Hampshire [Member] | |||||||||||
Commitments And Contingencies [Line Items] | |||||||||||
Charitable Contribution | 500,000 | ||||||||||
State of New Hampshire [Member] | Settled Litigation [Member] | |||||||||||
Commitments And Contingencies [Line Items] | |||||||||||
Litigation Settlement, Amount | 2,900,000 | ||||||||||
State of Massachusetts [Member] | Settled Litigation [Member] | |||||||||||
Commitments And Contingencies [Line Items] | |||||||||||
Loss Contingency, Estimate of Possible Loss | 500,000 | 500,000 | |||||||||
Kottayil vs. Insys Pharma, Inc. [Member] | Settled Litigation [Member] | |||||||||||
Commitments And Contingencies [Line Items] | |||||||||||
Litigation Settlement, Amount | $ 7,317,450 | ||||||||||
Loss Contingency, Damages Awarded, Value | $ 7,317,450 | ||||||||||
Litigation Settlement, Post-Judgment Interest | 4.25% | ||||||||||
Litigation Settlement, Expense | $ 93,163 | ||||||||||
Estimated Contingent Liability | 9,567,000 | 9,567,000 | |||||||||
Kottayil vs. Insys Pharma, Inc. [Member] | Settled Litigation [Member] | Settlement Interest [Member] | |||||||||||
Commitments And Contingencies [Line Items] | |||||||||||
Estimated Contingent Liability | 2,249,000 | 2,249,000 | |||||||||
Kottayil vs. Insys Pharma, Inc. [Member] | Threatened Litigation [Member] | |||||||||||
Commitments And Contingencies [Line Items] | |||||||||||
Loss Contingency, Damages Sought, Value | $ 3,630,000 | ||||||||||
Kottayil vs. Insys Pharma, Inc. [Member] | Threatened Litigation [Member] | Minimum [Member] | |||||||||||
Commitments And Contingencies [Line Items] | |||||||||||
Loss Contingency, Estimate of Possible Loss | 0 | ||||||||||
Kottayil vs. Insys Pharma, Inc. [Member] | Threatened Litigation [Member] | Maximum [Member] | |||||||||||
Commitments And Contingencies [Line Items] | |||||||||||
Loss Contingency, Estimate of Possible Loss | $ 3,630,000 | ||||||||||
DPT [Member] | |||||||||||
Commitments And Contingencies [Line Items] | |||||||||||
Contractual Obligation | 16,000,000 | 16,000,000 | |||||||||
Purchase Obligation Per Calendar Year | $ 4,000,000 | ||||||||||
Purchase Obligation | $ 16,000,000 | $ 49,740,000 | |||||||||
Aptargroup, Inc [Member] | |||||||||||
Commitments And Contingencies [Line Items] | |||||||||||
Term of Aptargroup, Inc Joint Agreement | 7 years | ||||||||||
Contractual Obligation | 20,290,000 | 20,290,000 | |||||||||
Letter of Credit Per Facility Lease Agreement [Member] | |||||||||||
Commitments And Contingencies [Line Items] | |||||||||||
Unused letter of credit | $ 400,000 | $ 400,000 |
Note 7 - Commitments and Cont51
Note 7 - Commitments and Contingencies - Summary of Aggregate Minimum Purchase Commitments (Details) $ in Thousands | Dec. 31, 2016USD ($) |
Years ending December 31, | |
2,017 | $ 7,500 |
2,018 | 7,500 |
2,019 | 8,410 |
2,020 | 8,550 |
2,021 | 4,330 |
Total | $ 36,290 |
Note 8 - Equity (Details Textua
Note 8 - Equity (Details Textual) | May 05, 2015$ / shares | Feb. 26, 2014$ / shares | Aug. 31, 2014Vote$ / sharesshares | Dec. 31, 2016USD ($)$ / sharesshares | Dec. 31, 2015$ / sharesshares | Nov. 05, 2015USD ($) | May 06, 2014$ / sharesshares | May 05, 2014shares |
Class Of Stock [Line Items] | ||||||||
Preferred Stock, Par or Stated Value Per Share | $ 0.01 | $ 0.01 | ||||||
Common Stock, Par or Stated Value Per Share | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 | ||||
Stockholders' Equity Note, Stock Split, Conversion Ratio | 2 | 1.5 | ||||||
Stock Issued during Period Per Share, Stock Split | 1 | 0.5 | ||||||
Common Stock, Shares Authorized | shares | 100,000,000 | 100,000,000 | 100,000,000 | 50,000,000 | ||||
Stock Repurchase Program, Authorized Amount | $ | $ 50,000,000 | |||||||
Pre-split Basis [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Common Stock, Par or Stated Value Per Share | $ 0.0002145 | |||||||
Common Stock [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Preferred Stock, Par or Stated Value Per Share | $ 0.001 | |||||||
Common Stock, Par or Stated Value Per Share | $ 0.01 | |||||||
Dividend declared, number of Series A Junior Participating Preferred Stock entitled per right | shares | 0.01 | |||||||
Preferred Stock Purchase Price | $ 160 | |||||||
Minimum Ownership Percentage Acquired to Trigger Preferred Stock Purchase Rights | 15.00% | |||||||
Rights expiry period | 10 years | |||||||
Preferred Stock, Dividend Rate, Per-Dollar-Amount | $ 1 | |||||||
Multiple used to Determine Preferred Stock Dividend | 100 | |||||||
Preferred Stock, Liquidation Preference Per Share | $ 100 | |||||||
Number of Votes for each Preferred Share | Vote | 100 | |||||||
Kapoor Notes [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Stock Repurchase Program, Remaining Authorized Amount | $ | $ 17,442,000 |
Note 8 - Equity - Summary of Sh
Note 8 - Equity - Summary of Share Repurchase Activity (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Equity [Abstract] | ||
Number of Shares Purchased, Beginning Balance | 560,200 | |
Number of Shares Purchased during Period | 843,075 | 560,200 |
Number of Shares Purchased, Ending Balance | 1,403,275 | 560,200 |
Cost of Share Purchases, Beginning Balance | $ 16,459,000 | |
Cost of Share Purchases during Period | 16,099,000 | $ 16,459,000 |
Cost of Share Purchases, Ending Balance | $ 32,558,000 | $ 16,459,000 |
Note 9 - Stock-based Compensa54
Note 9 - Stock-based Compensation (Details Textual) - USD ($) | 12 Months Ended | |||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 7,300,873 | 7,138,089 | 7,707,162 | 8,994,978 |
Share-based Compensation Arrangement by Share-based Payment Award Accelerated Compensation Cost | $ 3,878,000 | $ 4,867,000 | $ 4,016,000 | |
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Stock Options | $ 31,171,000 | |||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 2 years 7 months 6 days | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested in Period, Fair Value | $ 19,970,000 | 25,392,000 | 14,572,000 | |
Proceeds from Stock Options Exercised | 3,803,000 | 9,524,000 | 8,956,000 | |
Employee Service Share-based Compensation, Tax Benefit from Compensation Expense | $ 122,000 | $ 13,593,000 | $ 22,003,000 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 9.20 | $ 19.20 | $ 10.53 | |
Employee Stock Purchase Plan 2013 [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
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 | 1,465,176 | |||
Employee Stock Purchase Plan 2013 [Member] | Pre-split Basis [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Additional Annual Shares Automatically Authorized, Period Increase, Option Shares | 200,000 | |||
Equity Incentive Plan 2013 [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
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 | 7,300,873 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 4,259,755 |
Note 9 - Stock-based Compensa55
Note 9 - Stock-based Compensation - Amounts Recognized in Condensed Consolidated Statements of Income and Comprehensive Income with Respect to Stock-Based Compensation Plans (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Total cost of stock-based compensation | $ 21,589 | $ 21,882 | $ 15,289 |
Research and Development Expense [Member] | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Total cost of stock-based compensation | 3,931 | 2,133 | 5,498 |
General and Administrative Expense [Member] | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Total cost of stock-based compensation | $ 17,658 | $ 19,749 | $ 9,791 |
Note 9 - Stock-based Compensa56
Note 9 - Stock-based Compensation - Summary of Stock Option Activity (Detail) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |||
Number of Shares, Outstanding, Beginning balance | 7,138,089 | 7,707,162 | 8,994,978 |
Number of Shares, Granted | 2,337,043 | 1,733,671 | 3,397,198 |
Number of Shares, Cancelled | (1,536,538) | (695,061) | (1,068,224) |
Number of Shares, Exercised | (637,721) | (1,607,683) | (3,616,790) |
Number of Shares, Outstanding, Ending balance | 7,300,873 | 7,138,089 | 7,707,162 |
Number of Shares, Vested and exercisable as of December 31, 2016 | 4,474,906 | ||
Weighted Average Exercise Price, Outstanding, Beginning balance | $ 7.57 | $ 2.90 | $ 1.06 |
Weighted Average Exercise Price, Granted | 14.86 | 14.57 | 4.86 |
Weighted Average Exercise Price, Cancelled | 18.67 | 7.71 | 2.86 |
Weighted Average Exercise Price, Exercised | 5.96 | 2.48 | 1.15 |
Weighted Average Exercise Price, Outstanding, Ending balance | 12.36 | $ 7.57 | $ 2.90 |
Weighted Average Exercise Price, Vested and exercisable as of December 31, 2016 | $ 9.05 | ||
Weighted Average Remaining Contractual Term, Outstanding as of December 31, 2016 | 7 years 3 months 18 days | ||
Weighted Average Remaining Contractual Term, Vested and exercisable as of December 31, 2016 | 6 years 4 months 24 days | ||
Aggregate Intrinsic Value, Exercised | $ 7 | ||
Aggregate Intrinsic Value, Outstanding as of December 31, 2016 | 18.7 | ||
Aggregate Intrinsic Value, Vested and exercisable as of December 31, 2016 | $ 18 |
Note 9 - Stock-based Compensa57
Note 9 - Stock-based Compensation - Summary of Weighted-Average Assumptions used to Estimate Fair Value of Employee Stock Options (Detail) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |||
Expected volatility | 63.30% | 69.90% | 69.30% |
Risk-free interest rate | 1.60% | 1.90% | 1.70% |
Expected term (in years) | 7 years | 7 years | 6 years |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Note 10 - Income Taxes - Income
Note 10 - Income Taxes - Income Tax Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Current income taxes: | |||||||||||
Federal | $ 5,916 | $ 31,383 | $ 21,949 | ||||||||
State and local | 554 | 6,473 | 3,794 | ||||||||
Total current income tax | 6,470 | 37,856 | 25,743 | ||||||||
Deferred income taxes: | |||||||||||
Federal | (7,762) | (3,759) | 465 | ||||||||
State and local | 2,126 | (1,156) | (1,119) | ||||||||
Total deferred income tax | (5,636) | (4,915) | (654) | ||||||||
Income tax expense | $ 311 | $ (379) | $ 668 | $ 234 | $ 13,043 | $ 11,840 | $ 5,247 | $ 2,811 | $ 834 | $ 32,941 | $ 25,089 |
Note 10 - Income Taxes (Details
Note 10 - Income Taxes (Details Textual) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Income Tax Disclosure [Line Items] | |||
Deferred Tax Assets, Valuation Allowance | $ 23,508,000 | $ 20,203,000 | |
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 35.00% | 35.00% | 35.00% |
Effective Income Tax Rate Reconciliation, Percent | 9.90% | 36.10% | 41.10% |
Unrecognized Tax Benefits | $ 9,800,000 | $ 8,920,000 | $ 5,323,000 |
Unrecognized Tax Benefits that would Affect Effective Tax Rate if Recognized | 9,800,000 | ||
Unrecognized Tax Benefits, Interest on Income Taxes Accrued | 706,000 | ||
Tax Credits [Member] | |||
Income Tax Disclosure [Line Items] | |||
Unrecognized Tax Benefits | 2,610,000 | ||
State and Local Income Tax Filing Positions [Member] | |||
Income Tax Disclosure [Line Items] | |||
Unrecognized Tax Benefits | 5,412,000 | ||
Other Permanent Differences [Member] | |||
Income Tax Disclosure [Line Items] | |||
Unrecognized Tax Benefits | 1,778,000 | ||
Portion of Arizona Research and Development Credit and Illinois Net Operating Loss Carryforwards [Member] | |||
Income Tax Disclosure [Line Items] | |||
Deferred Tax Assets, Valuation Allowance | 23,500,000 | ||
Deferred Tax Assets, Increase in Valuation Allowance | 3,300,000 | ||
Domestic Tax Authority [Member] | |||
Income Tax Disclosure [Line Items] | |||
Operating Loss Carryforwards | 1,100,000 | ||
State and Local Jurisdiction [Member] | Illinois [Member] | |||
Income Tax Disclosure [Line Items] | |||
Deferred Tax Assets, Operating Loss Carryforwards, State and Local | 268,100,000 | ||
Deferred Tax Assets, Operating Loss Carryforwards, State and Local, Not Utilized | 266,100,000 | ||
Deferred Tax Assets, Valuation Allowance | 20,600,000 | ||
Deferred Tax Assets, Operating Loss Carryforwards, State and Local, Not Benefitted | $ 600,000 |
Note 10 - Income Taxes - Deferr
Note 10 - Income Taxes - Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Deferred income tax assets: | ||
NOLs and credits | $ 27,046 | $ 26,910 |
Start-up expenditures | 2,604 | 2,896 |
Stock-based compensation | 11,727 | 8,578 |
Allowances | 1,264 | 1,581 |
Expenses currently not deductible for tax purposes | 10,652 | 6,129 |
Other | 1,963 | 1,142 |
Gross deferred tax assets | 55,256 | 47,236 |
Deferred income tax asset valuation allowance | (23,508) | (20,203) |
Deferred income tax assets | 31,748 | 27,033 |
Deferred income tax liabilities: | ||
Federal impact of state taxes | (1,073) | (1,817) |
Property and equipment | (6,246) | (6,189) |
Prepaid expenses | (1,186) | (1,420) |
Net deferred income tax assets | $ 23,243 | $ 17,607 |
Note 10 - Income Taxes - Effect
Note 10 - Income Taxes - Effective Tax Rate Reconciliation (Details) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Income Tax Disclosure [Abstract] | |||
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 | (0.10%) | 2.30% | 4.10% |
Non-deductible litigation expense | 3.40% | 3.50% | 3.20% |
Non-deductible and includible items | 7.50% | 0.70% | 0.70% |
Non-deductible lobbying expense | 8.30% | ||
Research and other credits | (63.50%) | (5.40%) | (3.60%) |
Uncertain tax positions | 4.20% | 2.70% | 1.90% |
Domestic manufacturing deduction | (14.60%) | (3.00%) | (0.30%) |
Stock based compensation | 5.10% | 0.40% | 0.10% |
Tax exempt interest income | (1.50%) | ||
Other | 0.60% | ||
Change in valuation allowance | 25.50% | (0.10%) | |
Total provision for income taxes | 9.90% | 36.10% | 41.10% |
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, 2016 | Dec. 31, 2015 | |
Reconciliation Of Unrecognized Tax Benefits Excluding Amounts Pertaining To Examined Tax Returns Roll Forward | ||
Beginning balance | $ 8,920 | $ 5,323 |
Additions based on current year's tax positions | 758 | 3,837 |
Additions based on prior year's tax positions | 122 | (240) |
Ending balance | $ 9,800 | $ 8,920 |
Note 11 - Net Income Per Share
Note 11 - Net Income Per Share - Computation of Basic and Diluted Net Income (Loss) Per Common Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||||||
Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |||||
Historical net income per share - Basic | |||||||||||||||
Net income | $ (3,652) | [1] | $ 2,925 | [1] | $ 6,027 | [1] | $ 2,290 | [1] | $ 18,143 | $ 24,630 | $ 9,413 | $ 5,867 | $ 7,590 | $ 58,053 | $ 36,054 |
Weighted average number of common shares outstanding | 71,618,793 | 71,592,581 | 68,759,070 | ||||||||||||
Basic net income per common share | $ (0.05) | $ 0.04 | $ 0.08 | $ 0.03 | $ 0.25 | $ 0.34 | $ 0.13 | $ 0.08 | $ 0.11 | $ 0.81 | $ 0.52 | ||||
Historical net income per share - Diluted | |||||||||||||||
Net income | $ (3,652) | [1] | $ 2,925 | [1] | $ 6,027 | [1] | $ 2,290 | [1] | $ 18,143 | $ 24,630 | $ 9,413 | $ 5,867 | $ 7,590 | $ 58,053 | $ 36,054 |
Weighted average number of common shares outstanding | 71,618,793 | 71,592,581 | 68,759,070 | ||||||||||||
Effect of dilutive stock options | 2,527,125 | 4,115,070 | 4,576,062 | ||||||||||||
Weighted average number of common shares outstanding | 74,145,918 | 75,707,651 | 73,335,132 | ||||||||||||
Diluted net income per common share | $ (0.05) | $ 0.04 | $ 0.08 | $ 0.03 | $ 0.24 | $ 0.32 | $ 0.12 | $ 0.08 | $ 0.10 | $ 0.77 | $ 0.49 | ||||
[1] | The fourth quarter of 2016 includes charges related to litigation award and settlements of $3,900,000. |
Note 11 - Net Income Per Shar64
Note 11 - Net Income Per Share (Details Textual) - shares | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Earnings Per Share [Abstract] | |||
Anti-dilutive securities excluded from computation of earnings per share, Shares | 2,596,324 | 1,460,986 | 1,780,372 |
Note 12 - Product Lines, Conc65
Note 12 - Product Lines, Concentration of Credit Risk and Significant Customers - Summary of Net Revenue by Product Line and Percentages (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Segment Reporting Information [Line Items] | |||||||||||
Revenues | $ 54,860 | $ 57,773 | $ 69,221 | $ 60,421 | $ 93,914 | $ 88,517 | $ 80,200 | $ 67,692 | $ 242,275 | $ 330,323 | $ 219,092 |
SUBSYS [Member] | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Revenues | $ 242,275 | 329,040 | 216,497 | ||||||||
Dronabinol SG Capsule [Member] | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Revenues | $ 1,283 | $ 2,595 |
Note 12 - Product Lines, Conc66
Note 12 - Product Lines, Concentration of Credit Risk and Significant Customers - Percentage of Revenue by Route to Market (Details) - Sales Revenue, Product Line [Member] - Product Concentration Risk [Member] | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Segment Reporting Information [Line Items] | |||
Concentration Risk Percentage | 100.00% | 100.00% | 100.00% |
Pharmaceutical Wholesalers [Member] | |||
Segment Reporting Information [Line Items] | |||
Concentration Risk Percentage | 67.00% | 95.00% | 99.00% |
Specialty Pharmaceutical Retailers [Member] | |||
Segment Reporting Information [Line Items] | |||
Concentration Risk Percentage | 33.00% | 5.00% | 0.00% |
Generic Pharmaceutical Distributor [Member] | |||
Segment Reporting Information [Line Items] | |||
Concentration Risk Percentage | 0.00% | 0.00% | 1.00% |
Note 12 - Product Lines, Conc67
Note 12 - Product Lines, Concentration of Credit Risk and Significant Customers (Details Textual) | 12 Months Ended | ||
Dec. 31, 2016USD ($)Wholesaler | Dec. 31, 2015Wholesaler | Dec. 31, 2014Wholesaler | |
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | |||
Cash, FDIC Insured Amount | $ | $ 250,000 | ||
Pharmaceutical Wholesalers [Member] | Product Shipments [Member] | |||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | |||
Concentration Risk, Number of Customers | 4 | 4 | 4 |
Pharmaceutical Wholesalers [Member] | Product Shipments [Member] | Customer One [Member] | |||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | |||
Concentration Risk, Percentage | 17.00% | 32.00% | 38.00% |
Pharmaceutical Wholesalers [Member] | Product Shipments [Member] | Customer Two [Member] | |||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | |||
Concentration Risk, Percentage | 16.00% | 20.00% | 22.00% |
Pharmaceutical Wholesalers [Member] | Product Shipments [Member] | Customer Three [Member] | |||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | |||
Concentration Risk, Percentage | 15.00% | 17.00% | 14.00% |
Pharmaceutical Wholesalers [Member] | Product Shipments [Member] | Customer Four [Member] | |||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | |||
Concentration Risk, Percentage | 14.00% | 14.00% | 14.00% |
Pharmaceutical Wholesalers [Member] | Accounts Receivable [Member] | |||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | |||
Concentration Risk, Number of Customers | 4 | 4 | |
Pharmaceutical Wholesalers [Member] | Accounts Receivable [Member] | Customer One [Member] | |||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | |||
Concentration Risk, Percentage | 36.00% | 20.00% | |
Pharmaceutical Wholesalers [Member] | Accounts Receivable [Member] | Customer Two [Member] | |||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | |||
Concentration Risk, Percentage | 23.00% | 19.00% | |
Pharmaceutical Wholesalers [Member] | Accounts Receivable [Member] | Customer Three [Member] | |||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | |||
Concentration Risk, Percentage | 21.00% | 17.00% | |
Pharmaceutical Wholesalers [Member] | Accounts Receivable [Member] | Customer Four [Member] | |||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | |||
Concentration Risk, Percentage | 13.00% | 14.00% | |
Pharmaceutical Retailer [Member] | Product Shipments [Member] | Customer One [Member] | |||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | |||
Concentration Risk, Percentage | 32.00% | ||
Concentration Risk, Number of Customers | 1 |
Note 13 - Supplemental Financ68
Note 13 - Supplemental Financial Information - Allowances for Accounts Receivables (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Allowance for Doubtful Accounts [Member] | |||
Valuation And Qualifying Accounts Disclosure [Line Items] | |||
Balance at Beginning of Year | $ 811 | $ 398 | |
Charged to Costs and Expenses | (96) | 413 | $ 398 |
Utilization | (30) | ||
Balance at End of Year | 685 | 811 | 398 |
Allowance for Sales Wholesaler Discounts Prompt Pay Discounts Stocking Allowances and Chargebacks [Member] | |||
Valuation And Qualifying Accounts Disclosure [Line Items] | |||
Balance at Beginning of Year | 7,556 | 5,418 | 2,748 |
Charged to Costs and Expenses | 27,968 | 38,036 | 22,395 |
Utilization | (30,065) | (35,898) | (19,725) |
Balance at End of Year | $ 5,459 | $ 7,556 | $ 5,418 |
Note 14 - Quarterly Results o69
Note 14 - Quarterly Results of Operations (Unaudited) - Schedule of Quarterly Results of Operations (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |||||||||||||
Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |||||
Quarterly Financial Information [Line Items] | |||||||||||||||
Net revenue | $ 54,860,000 | $ 57,773,000 | $ 69,221,000 | $ 60,421,000 | $ 93,914,000 | $ 88,517,000 | $ 80,200,000 | $ 67,692,000 | $ 242,275,000 | $ 330,323,000 | $ 219,092,000 | ||||
Gross profit | 45,055,000 | [1] | 53,096,000 | [1] | 62,948,000 | [1] | 55,783,000 | [1] | 87,447,000 | 80,810,000 | 71,895,000 | 61,317,000 | 216,882,000 | 301,469,000 | 196,514,000 |
Total operating expenses | 48,688,000 | 50,831,000 | 56,504,000 | 53,533,000 | 56,448,000 | 44,431,000 | 57,370,000 | 52,764,000 | 209,556,000 | 211,013,000 | 135,524,000 | ||||
Income before income taxes | (3,341,000) | 2,546,000 | 6,695,000 | 2,524,000 | 31,186,000 | 36,470,000 | 14,660,000 | 8,678,000 | 8,424,000 | 90,994,000 | 61,143,000 | ||||
Income tax expense (benefit) | 311,000 | (379,000) | 668,000 | 234,000 | 13,043,000 | 11,840,000 | 5,247,000 | 2,811,000 | 834,000 | 32,941,000 | 25,089,000 | ||||
Net income (loss) | (3,652,000) | [2] | 2,925,000 | [2] | 6,027,000 | [2] | 2,290,000 | [2] | 18,143,000 | 24,630,000 | 9,413,000 | 5,867,000 | 7,590,000 | 58,053,000 | 36,054,000 |
Total comprehensive income | $ (3,880,000) | $ 2,767,000 | $ 6,097,000 | $ 2,456,000 | $ 17,958,000 | $ 24,680,000 | $ 9,392,000 | $ 5,895,000 | $ 7,440,000 | $ 57,925,000 | $ 36,030,000 | ||||
Net income per common share: | |||||||||||||||
Basic | $ (0.05) | $ 0.04 | $ 0.08 | $ 0.03 | $ 0.25 | $ 0.34 | $ 0.13 | $ 0.08 | $ 0.11 | $ 0.81 | $ 0.52 | ||||
Diluted | $ (0.05) | $ 0.04 | $ 0.08 | $ 0.03 | $ 0.24 | $ 0.32 | $ 0.12 | $ 0.08 | $ 0.10 | $ 0.77 | $ 0.49 | ||||
As Originally Reported [Member] | |||||||||||||||
Quarterly Financial Information [Line Items] | |||||||||||||||
Net revenue | $ 55,180,000 | $ 67,121,000 | $ 61,962,000 | $ 91,135,000 | $ 91,259,000 | $ 77,633,000 | $ 70,770,000 | $ 330,797,000 | $ 222,125,000 | ||||||
Gross profit | 50,503,000 | [1] | 60,848,000 | [1] | 57,324,000 | [1] | 84,668,000 | 83,552,000 | 69,328,000 | 64,395,000 | 301,943,000 | 199,547,000 | |||
Total operating expenses | 50,831,000 | 56,504,000 | 55,033,000 | 54,948,000 | 44,431,000 | 57,370,000 | 52,764,000 | 209,513,000 | |||||||
Income before income taxes | (47,000) | 4,595,000 | 2,565,000 | 29,907,000 | 39,212,000 | 12,093,000 | 11,756,000 | 92,968,000 | 64,176,000 | ||||||
Income tax expense (benefit) | (237,000) | 240,000 | 131,000 | 12,896,000 | 13,084,000 | 4,779,000 | 3,733,000 | 34,492,000 | 26,199,000 | ||||||
Net income (loss) | 190,000 | [2] | 4,355,000 | [2] | 2,434,000 | [2] | 17,011,000 | 26,128,000 | 7,314,000 | 8,023,000 | 58,476,000 | 37,977,000 | |||
Total comprehensive income | 32,000 | $ 4,425,000 | $ 2,600,000 | $ 16,826,000 | $ 26,178,000 | $ 7,293,000 | $ 8,051,000 | $ 58,348,000 | $ 37,953,000 | ||||||
Net income per common share: | |||||||||||||||
Basic | $ 0.06 | $ 0.03 | $ 0.24 | $ 0.36 | $ 0.10 | $ 0.11 | $ 0.82 | $ 0.55 | |||||||
Diluted | $ 0.06 | $ 0.03 | $ 0.22 | $ 0.34 | $ 0.10 | $ 0.11 | $ 0.77 | $ 0.52 | |||||||
Adjustment [Member] | |||||||||||||||
Quarterly Financial Information [Line Items] | |||||||||||||||
Net revenue | $ (474,000) | $ (3,033,000) | |||||||||||||
Gross profit | (474,000) | (3,033,000) | |||||||||||||
Total operating expenses | 1,500,000 | ||||||||||||||
Income before income taxes | 2,593,000 | $ 2,100,000 | $ (41,000) | $ 1,279,000 | $ (2,742,000) | $ 2,567,000 | $ (3,078,000) | (1,974,000) | (3,033,000) | ||||||
Income tax expense (benefit) | (142,000) | 428,000 | 103,000 | 147,000 | (1,244,000) | 468,000 | (922,000) | (1,551,000) | (1,110,000) | ||||||
Net income (loss) | 2,735,000 | 1,672,000 | (144,000) | 1,132,000 | (1,498,000) | 2,099,000 | (2,156,000) | (423,000) | (1,923,000) | ||||||
Total comprehensive income | $ 2,735,000 | $ 1,672,000 | $ (144,000) | $ 1,132,000 | $ (1,498,000) | $ 2,099,000 | $ (2,156,000) | $ (423,000) | $ (1,923,000) | ||||||
Net income per common share: | |||||||||||||||
Basic | $ 0.04 | $ 0.02 | $ 0 | $ 0.01 | $ (0.02) | $ 0.03 | $ (0.03) | $ (0.01) | $ (0.03) | ||||||
Diluted | $ 0.04 | $ 0.02 | $ 0 | $ 0.02 | $ (0.02) | $ 0.02 | $ (0.03) | $ 0 | $ (0.03) | ||||||
Adjustment [Member] | Prior Period Underestimation of Sales Allowances [Member] | |||||||||||||||
Quarterly Financial Information [Line Items] | |||||||||||||||
Net revenue | $ 2,593,000 | $ 2,100,000 | $ (1,541,000) | $ 2,779,000 | $ (2,742,000) | $ 2,567,000 | $ (3,078,000) | ||||||||
Gross profit | $ 2,593,000 | $ 2,100,000 | (1,541,000) | 2,779,000 | $ (2,742,000) | $ 2,567,000 | $ (3,078,000) | ||||||||
Adjustment [Member] | Prior Period Stock Option Modification [Member] | |||||||||||||||
Quarterly Financial Information [Line Items] | |||||||||||||||
Total operating expenses | $ (1,500,000) | $ 1,500,000 | |||||||||||||
[1] | The fourth quarter of 2016 includes an allowance of $5,800,000 for excess and obsolete SUBSYS® inventory. | ||||||||||||||
[2] | The fourth quarter of 2016 includes charges related to litigation award and settlements of $3,900,000. |
Note 14 - Quarterly Results o70
Note 14 - Quarterly Results of Operations (Unaudited) - Schedule of Quarterly Results of Operations (Parenthetical) (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2016 | Dec. 31, 2015 | |
Quarterly Financial Information [Line Items] | |||
Charges related to litigation award and settlements | $ 3,900,000 | $ 3,900,000 | $ 10,616,000 |
SUBSYS [Member] | Inventory Valuation and Obsolescence [Member] | |||
Quarterly Financial Information [Line Items] | |||
Allowance for inventory | $ 5,800,000 |