Document And Entity Information
Document And Entity Information - shares | 3 Months Ended | |
Mar. 31, 2019 | May 06, 2019 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | INSY | |
Entity Registrant Name | Insys Therapeutics, Inc. | |
Entity Central Index Key | 0001516479 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Common Stock, Shares Outstanding (in shares) | 74,569,163 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Current Assets: | ||
Cash and cash equivalents | $ 36,513 | $ 31,552 |
Short-term investments | 47,380 | 64,126 |
Accounts receivable, net | 6,087 | 12,610 |
Inventories, net | 7,246 | 8,608 |
Prepaid expenses and other current assets | 8,501 | 9,396 |
Total current assets | 105,727 | 126,292 |
Property and equipment, net | 47,810 | 52,086 |
Operating lease right-of-use assets | 11,036 | |
Long-term investments | 3,726 | 8,446 |
Other assets | 4,301 | 5,703 |
Total assets | 172,600 | 192,527 |
Current Liabilities: | ||
Accounts payable and accrued expenses (including accrued legal expenses of $56,843 and $32,625 at March 31, 2019 and December 31, 2018, respectively | 67,095 | 50,778 |
Accrued compensation | 2,640 | 6,437 |
Accrued sales allowances | 7,157 | 8,162 |
Current portion of operating lease liabilities | 1,839 | |
Current portion of uncertain income tax positions | 1,219 | |
Accrued litigation award and settlements | 115,265 | 41,402 |
Total current liabilities | 195,215 | 106,779 |
Operating lease liabilities | 12,163 | |
Noncurrent accrued litigation awards and settlements | 125,000 | 125,000 |
Uncertain income tax positions | 3,861 | 3,767 |
Other noncurrent liabilities | 85 | 81 |
Total liabilities | 336,324 | 235,627 |
Commitments and Contingencies (Note 8) | ||
Stockholders' Deficit: | ||
Preferred stock (par value $0.001 per share; 10,000,000 shares authorized; 0 shares issued and outstanding as of March 31, 2019 and December 31, 2018, respectively) | 0 | 0 |
Common stock (par value $0.01 per share; 100,000,000 shares authorized; 74,513,286 and 74,381,303 shares issued and outstanding as of March 31, 2019 and December 31, 2018, respectively) | 745 | 744 |
Additional paid in capital | 295,634 | 292,508 |
Unrealized loss on available-for-sale securities, net of tax | (176) | (269) |
Accumulated deficit | (459,927) | (336,083) |
Total stockholders' deficit | (163,724) | (43,100) |
Total liabilities and stockholders' deficit | $ 172,600 | $ 192,527 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Statement Of Financial Position [Abstract] | ||
Accrued legal expenses | $ 56,843 | $ 32,625 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 100,000,000 | 100,000,000 |
Common stock, shares issued (in shares) | 74,513,286 | 74,381,303 |
Common stock, shares outstanding (in shares) | 74,513,286 | 74,381,303 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Income Statement [Abstract] | ||
Net revenue | $ 7,630 | $ 23,911 |
Cost of revenue | 4,575 | 2,204 |
Gross profit | 3,055 | 21,707 |
Operating expenses: | ||
Sales and marketing | 4,119 | 9,051 |
Research and development | 10,523 | 12,260 |
General and administrative | 10,986 | 9,552 |
Legal | 25,677 | 10,337 |
Charges related to litigation award and settlements | 73,863 | 740 |
Total operating expenses | 125,168 | 41,940 |
Operating loss | (122,113) | (20,233) |
Other income (expense): | ||
Interest income | 423 | 503 |
Other expense, net | (908) | (469) |
Total other income (expense) | (485) | 34 |
Loss before income taxes | (122,598) | (20,199) |
Income tax expense | 1,246 | 171 |
Net loss | (123,844) | (20,370) |
Unrealized gain (loss) on available-for-sale securities, net of tax of $27 and $0 | 93 | (112) |
Total comprehensive loss | $ (123,751) | $ (20,482) |
Net loss per common share: | ||
Basic | $ (1.66) | $ (0.28) |
Diluted | $ (1.66) | $ (0.28) |
Weighted average common shares outstanding | ||
Basic | 74,426,030 | 73,745,202 |
Diluted | 74,426,030 | 73,745,202 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Income Statement [Abstract] | ||
Unrealized gain (loss) on available-for-sale securities, tax | $ 27 | $ 0 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity (Deficit) (Unaudited) - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid in Capital [Member] | Unrealized Gain (Loss) on Available-For-Sale Securities [Member] | Notes Receivable From Stockholders [Member] | Accumulated Deficit [Member] |
Balance at Dec. 31, 2017 | $ 66,209 | $ 736 | $ 278,356 | $ (438) | $ (21) | $ (212,424) |
Balance (in shares) at Dec. 31, 2017 | 73,612,052 | |||||
Adoption of new accounting standard ASC 606 | 848 | 848 | ||||
Exercise of stock options | 524 | $ 2 | 522 | |||
Exercise of stock options (in shares) | 146,859 | |||||
Stock-based compensation- stock options, awards, and restricted stock units | 3,170 | 3,170 | ||||
Unrealized gain (loss) on available-for-sale securities, net of tax | (112) | (112) | ||||
Vesting of restricted stock units (in shares) | 49,910 | |||||
Write-off of notes receivable from stockholders | 21 | $ 21 | ||||
Net loss | (20,370) | (20,370) | ||||
Balance at Mar. 31, 2018 | 50,290 | $ 738 | 282,048 | (550) | (231,946) | |
Balance (in shares) at Mar. 31, 2018 | 73,808,821 | |||||
Balance at Dec. 31, 2018 | (43,100) | $ 744 | 292,508 | (269) | (336,083) | |
Balance (in shares) at Dec. 31, 2018 | 74,381,303 | |||||
Exercise of stock options | $ 18 | 18 | ||||
Exercise of stock options (in shares) | 4,537 | 4,537 | ||||
Stock-based compensation- stock options, awards, and restricted stock units | $ 3,109 | 3,109 | ||||
Unrealized gain (loss) on available-for-sale securities, net of tax | 93 | 93 | ||||
Vesting of restricted stock units | $ 1 | (1) | ||||
Vesting of restricted stock units (in shares) | 127,446 | |||||
Net loss | (123,844) | (123,844) | ||||
Balance at Mar. 31, 2019 | $ (163,724) | $ 745 | $ 295,634 | $ (176) | $ (459,927) | |
Balance (in shares) at Mar. 31, 2019 | 74,513,286 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Cash flows from operating activities: | ||
Net loss | $ (123,844) | $ (20,370) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Inventory obsolescence reserve | 2,831 | 528 |
Depreciation and amortization | 1,961 | 1,938 |
Stock-based compensation | 3,109 | 3,170 |
Loss on disposal of property and equipment | 851 | 108 |
Impairment on property and equipment | 129 | |
Write-off of notes receivable and other assets due from stockholders | 26 | |
Non-cash operating lease expense | (34) | |
Amortization of investment discount | (58) | 93 |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | 6,523 | 6,002 |
Inventories | 195 | 1,035 |
Prepaid expenses and other current assets | 1,633 | (361) |
Accounts payable, accrued expenses and other current and noncurrent liabilities | 15,968 | (6,535) |
Accrued sales allowances | (1,005) | (3,777) |
Accrued litigation award and settlements | 75,082 | 740 |
Net cash used in operating activities | (16,659) | (17,403) |
Cash flows from investing activities: | ||
Purchases of investments | (6,005) | (25,394) |
Proceeds from sales of investments | 6,880 | |
Proceeds from maturities of investments | 27,622 | 22,703 |
Purchases of property and equipment | (15) | (760) |
Net cash provided by investing activities | 21,602 | 3,429 |
Cash flows from financing activities: | ||
Proceeds from exercise of stock options | 18 | 524 |
Net cash provided by financing activities | 18 | 524 |
Change in cash and cash equivalents | 4,961 | (13,450) |
Cash and cash equivalents, beginning of period | 31,552 | 31,999 |
Cash and cash equivalents, end of period | 36,513 | 18,549 |
Supplemental cash flow disclosures: | ||
Cash paid (refunded) for income taxes, net | (66) | 43 |
Non-cash capital expenditures | $ 9 | $ 889 |
Nature of Business and Basis of
Nature of Business and Basis of Presentation | 3 Months Ended |
Mar. 31, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Nature of Business and Basis of Presentation | 1. Nature of Business and Basis of Presentation Insys Therapeutics, Inc., which was incorporated in Delaware in June 1990, and our subsidiaries (collectively, “we,” “us,” and “our”) maintain headquarters in Chandler, Arizona. We are a specialty pharmaceutical company that develops and commercializes innovative drugs and novel drug delivery systems of therapeutic molecules that improve patients’ quality of life. As of March 31, 2019, we have two marketed products: SUBSYS®, a proprietary sublingual fentanyl spray indicated for the management of BTCP patients 18 years of age and older who are already receiving and are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain; and SYNDROS®, a proprietary, orally administered liquid formulation of dronabinol for the treatment of nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments and anorexia associated with weight loss in patients with AIDS. The accompanying condensed consolidated financial statements are unaudited and have been prepared in accordance with U.S. GAAP, pursuant to rules and regulations of the SEC. Certain information and footnote disclosures have been condensed or omitted pursuant to such rules and regulations. In the opinion of management, the accompanying unaudited condensed consolidated financial statements include normal recurring adjustments that are necessary for a fair presentation of the results for the interim periods presented. Certain recurring seasonal factors relating to the commencement of a new calendar year may have an adverse effect on net revenue in the first quarter. These unaudited condensed consolidated financial statements should be read in conjunction with our audited consolidated financial statements and notes thereto for the fiscal year ended December 31, 2018, included in our Annual Report on Form 10-K. The results of operations for the three months ended March 31, 2019, are not necessarily indicative of results to be expected for the full fiscal year or any other periods. The preparation of the unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make a number of estimates and judgments that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expense during the reported period. On an ongoing basis, we evaluate our estimates, including those related to revenue recognition (which are affected by prescriptions dispensed, wholesaler discounts, patient discount programs, rebates, returns, and chargebacks), inventories, legal liabilities and settlements, stock-based compensation expense, income taxes, and deferred tax valuation allowances. We base our estimates on historical experience and on various other assumptions that are believed by management to be reasonable under the circumstances. Actual results could materially differ from these estimates. All significant intercompany balances and transactions have been eliminated in the accompanying unaudited condensed consolidated financial statements. Going Concern Uncertainty As of March 31, 2019, the Company had an accumulated deficit of $459.9 million , negative cash flows of $16.7 million from operating activities for the three months ended March 31, 2019, and significant ongoing legal expenses. While we have no outstanding debt, our available liquidity is limited to $87.6 million in cash and cash equivalents and investments as of March 31, 2019, and we expect to have continued negative cash flows from operating activities. We have experienced recurring and increasing losses from operations over the previous 18 months due to significant declines in the TIRF market and significant legal expenses resulting from the DOJ Investigation and other significant litigation matters to which we are subject (see Note 8 of the notes to our unaudited condensed consolidated financial statements for a discussion of these legal matters). We have estimated liabilities of approximately $240.3 million as of March 31, 2019 for proposed settlements of our various litigation matters, and there are other matters for which we have not been able to determine a reasonable estimated loss. Furthermore, we are uncertain if we will be able to complete a final settlement with the DOJ because of the Company’s inability to fulfill demands made by the DOJ, including the execution of a security agreement relating to the assets of the Company to collateralize payments under the settlement. These factors raise substantial doubt about the Company’s ability to continue as a going concern within one year of the issuance date of these unaudited condensed consolidated financial statements. Management’s plans, in order to meet our operating cash flow requirements, include the pursuit of strategic alternatives related to the sale or licensing of the Company’s assets. On November 5, 2018, we announced that we commenced a process to review strategic alternatives for our portfolio of opioid-related assets, including SUBSYS®, as well as formulations of buprenorphine and the combination of buprenorphine/naloxone. The Company has engaged Lazard Freres & Co. LLC to advise the Company on capital planning and the evaluation of strategic alternatives. There are no assurances that the Company will be successful in implementing a strategic plan for the sale or licensing of its assets in order to address its impending liquidity constraints. If the Company cannot successfully implement its strategic plan for the sale or licensing of its assets, and/or reach an agreement with the DOJ, its liquidity, financial condition and business prospects will be materially and adversely affected. Accordingly, it may be necessary for the Company to file a voluntary petition for relief under Chapter 11 of the United States Bankruptcy Code in order to implement a restructuring. Our Board of Directors has not made any decisions related to any strategic alternatives at this time. R ecently Adopted Accounting Pronouncements Effective January 1, 2019, we adopted the requirements of ASU No. 2016-02, “Leases: (Topic 842),” and all related amendments (“new lease standard”). The core principle of the new lease standard 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. We initially applied the new lease standard at the adoption date of January 1, 2019, with no cumulative effect adjustment to retained earnings, and elected all of the practical expedients, with the exception of hindsight to determine the lease term, and combining lease and non-lease components. We have elected not to apply the recognition and measurement requirements of the new lease standard to short-term leases, which are those with terms of twelve months or less with no option or intent to purchase the underlying asset at the term of the lease. We recognize lease payments associated with short-term leases on a straight-line basis over the term of the lease. We have presented additional qualitative and quantitative disclosures regarding the Company’s lease obligations as required upon implementation of ASC 842 in Note 7, Leases Leases Effective January 1, 2019, we adopted ASU No. 2017-08, “Receivables—Nonrefundable Fees and Other Costs (Subtopic 310-20): Premium Amortization on Purchased Callable Debt Securities,” to amend the amortization period for certain purchased callable debt securities held at a premium. The ASU shortens the amortization period for the premium to the earliest call date. Under current U.S. GAAP, entities generally amortize the premium as an adjustment of yield over the contractual life of the instrument. The adoption of this guidance had no impact on our unaudited condensed consolidated financial statements. Recent Accounting Pronouncements In August 2018, the FASB issued ASU No. 2018-13, “Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement,” to improve the effectiveness of disclosures. The amendments remove, modify, and add certain disclosure requirements in Topic 820, “Fair Value Measurement.” The amendments on changes in unrealized gains and losses, the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements, and the narrative description of measurement uncertainty should be applied prospectively for only the most recent interim or annual period presented in the initial fiscal year of adoption. All other amendments should be applied retrospectively to all periods presented upon their effective date. The amendments are effective for fiscal years beginning after December 15, 2019. Early adoption is permitted, including adoption in an interim period. Furthermore, an entity is permitted to early adopt any removed or modified disclosures upon issuance of the update and delay adoption of the additional disclosures until their effective date. We do not expect this amendment to have a material impact on our consolidated financial statements. In June 2016, the FASB issued ASU No. 2016-13, “Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments.” The amendments effected by this ASU affect entities holding financial assets and net investment in leases that are not accounted for at fair value through net income and are effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years, and early adoption is permitted. ASU 2016-13 amends the impairment model to utilize an expected loss methodology in place of the currently used incurred loss methodology, which will result in the timelier recognition of losses. We do not expect this amendment to have a material impact on our consolidated financial statements. |
Revenue Recognition
Revenue Recognition | 3 Months Ended |
Mar. 31, 2019 | |
Revenue From Contract With Customer [Abstract] | |
Revenue Recognition | 2. Revenue Recognition SUBSYS® was commercially launched in March 2012 and is monitored by an FDA-mandated REMS program known as the TIRF REMS. SYNDROS® was commercially launched in July 2017. We sell all of our products in the United States to our customers. See Note 11, Product Lines, Concentration of Credit Risk and Significant Customers To determine revenue recognition for contractual arrangements that we determine are within the scope of ASC Topic 606, we perform the following five steps: (i) identify each contract with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to our performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy the relevant performance obligation. We only apply the five-step model to contracts when it is probable that we will collect the consideration we are entitled to in exchange for the goods we transfer to the customer. We recognize revenue from the sale of our commercially approved products, SUBSYS® and SYNDROS®, when we transfer control of our products to our customers, as our contracts have a single performance obligation (delivery of our product to their preferred location) . Revenue is measured as the amount of consideration we expect to receive in exchange for transferring goods. Any shipping and handling activities that we perform, whether before or after a customer has obtained control of the products, are considered activities to fulfill our obligation to transfer the products, and are recorded as incurred within sales and marketing expenses. We offer the following discounts to our customers: Wholesaler and Retailer Discounts. We offer discounts to certain wholesale distributors and specialty retailers based on contractually determined rates. We record receivables due from the wholesalers and retailers net of these discounts upon shipment to the respective wholesale distributors and retail pharmacies. Prompt Pay Discounts . We offer cash discounts to our customers, generally 2% of the sales price, as an incentive for prompt payment. We record receivables net of these cash discounts 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 record receivables due from the wholesalers and retailers net of these discounts upon shipment to the respective wholesale distributors and retail pharmacies. The extended payment terms are not greater than 12 months and therefore do not include a financing component. As is customary in the pharmaceutical industry, it is common for our contracts to include product sales allowances that can decrease the transaction price and are therefore considered to be variable consideration. Product sales allowances, which include product returns, patient discount programs, rebates and chargebacks, are variable consideration and are based on amounts owed or to be claimed on the related sales. We estimate variable consideration when determining the transaction price using the expected value method. We assess whether variable consideration is constrained and only include estimated amounts in the transaction price to the extent it is probable that a significant reversal of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is resolved. Our estimates of variable consideration and determination of whether to include estimated amounts in the transaction price are based largely on historical data, and take into consideration the terms of our agreements with customers and third-party payers and the levels of inventory within the distribution channels that may result in future discounts taken. In certain cases, such as patient assistance programs, our estimates are based on estimated utilization. If actual future results vary, we may need to adjust these estimates, which could have an effect on revenue in the period of adjustment. During the three months ended March 31, 2019, we recognized revenue of $0.5 million related to changes in the estimated transaction price allocated to performance obligations satisfied in prior periods. Product Returns. We allow customers to return product for credit beginning six months prior to, and ending 12 months following, the product expiration date. SUBSYS® currently has a shelf life of 36 or 48 months from the date of manufacture, depending on the manufacture date, and SYNDROS® currently has a shelf life of 24 or 36 months from the date of manufacture, depending on the manufacture date. We have monitored actual return history since product launch, which provides us with a basis to reasonably estimate future product returns, taking into consideration the shelf life of product at the time of shipment, shipment and prescription trends, estimated distribution channel inventory levels and consideration of the introduction of competitive products. Because of the shelf life of our products and our return policy of issuing credits on returned product that is within six months before, and up to 12 months following, the product expiration date, there may be a significant period of time between when the product is shipped and when we issue credits on returned products. Accordingly, we may have to adjust these estimates, which could have a material effect on net revenue and earnings in the period of adjustment. The allowance for product returns is included in accrued sales allowances. Patient Discount Programs . We offer discount card programs to patients, in which patients receive discounts on their prescriptions that are reimbursed by us to the retailer. We estimate the total amount that will be redeemed based on a percentage of actual redemptions applied to inventory in the distribution and retail channels. The allowance for patient discount programs is included in accrued sales allowances. Rebates. We participate in certain rebate programs, which provide discounted prescriptions to qualified insured patients. Under these rebate programs, we pay a rebate to the third-party administrator of the program, generally two to three months after the quarter in which prescriptions subject to the rebate are filled. We estimate and accrue these rebates based on current and estimated future contract prices, historical and estimated future percentages of products prescribed to qualified patients and estimated levels of inventory in the distribution channel. The allowance for rebates is included in accrued sales allowances. Chargebacks. We provide discounts primarily to authorized users of the FSS of the General Services Administration under an FSS contract negotiated by the Department of Veterans Affairs and various organizations under Medicaid contracts and regulations. These organizations purchase products from the wholesale distributors at a discounted price, and the wholesale distributors then charge back to us the difference between the current retail price and the price the organization paid for the product. We estimate chargebacks based on estimated wholesaler inventory levels, current contract and estimated future prices and historical chargeback activity. We do not have any significant extended payment terms as payment is received shortly after the point of sale. As of March 31, 2019, the majority of our accounts receivables were related to product sales. For the three months ended March 31, 2019, the Company had no material bad-debt write-offs in the unaudited condensed consolidated statement of operations and comprehensive income (loss) and there were no contract assets, contract liabilities or deferred contract costs |
Short-Term and Long-Term Invest
Short-Term and Long-Term Investments | 3 Months Ended |
Mar. 31, 2019 | |
Schedule Of Investments [Abstract] | |
Short-Term and Long-Term Investments | 3. Short-Term and Long-Term Investments Our policy for short-term and long-term investments is to establish a high-quality portfolio that preserves principal, meets liquidity needs, avoids inappropriate concentrations, and delivers an appropriate yield in relationship to our investment guidelines and market conditions. Short-term and long-term investments consist of corporate and various government agency and municipal debt securities, commercial paper, as well as certificates of deposit that have maturity dates that are greater than 90 days. Certificates of deposit and commercial paper are carried at cost, which approximates fair value. We classify our marketable securities as available-for-sale in accordance with FASB ASC Topic 320, “Investments — Debt and Equity Securities.” Investments in debt securities that are classified as available-for-sale are carried at fair value with unrealized gains and losses reported in stockholders’ equity, net of related tax effects. There were no reclassifications on available-for-sale securities during the three months ended March 31, 2019. A decline in the market value of any available-for-sale security below cost that is deemed to be other than temporary results in impairment of the fair value of the investment. If we had unrealized losses and declines in value judged to be other than temporary, we would have been required to include those changes in other income (expense) in the unaudited condensed consolidated statements of operations and comprehensive loss. Premiums and discounts are amortized or accreted over the life of the related available-for-sale security. The cost of securities sold is calculated using the specific identification method. At March 31, 2019, our certificates of deposit and commercial paper as well as our marketable securities have been recorded at an estimated fair value of $3,537,000, $47,380,000, and $3,208,000 in cash and cash equivalents, short-term and long-term investments, respectively. Cash, cash equivalents and investments consisted of the following at March 31, 2019 (in thousands): Cost Gross Unrealized Gains Gross Unrealized Losses Other- Than- Temporary Impairment Losses Fair Value Cash and Cash Equivalents Short-term Investments Long-term Investments Cash and cash equivalents $ 8,716 $ — $ — $ — $ 8,716 $ 8,716 $ — $ — Money market securities 24,260 — — — 24,260 24,260 — — Marketable securities: Certificates of deposit 9,044 — — — 9,044 — 8,064 980 Commercial paper 7,068 — — — 7,068 3,537 3,531 — Corporate securities 20,279 1 (30 ) — 20,250 — 20,250 — Federal agency securities 16,481 1 (69 ) — 16,413 — 14,185 2,228 Municipal securities 1,352 — (2 ) — 1,350 — 1,350 — Total marketable securities 54,224 2 (101 ) — 54,125 3,537 47,380 3,208 Preferred stock 518 — — — 518 — — 518 $ 87,718 $ 2 $ (101 ) $ — $ 87,619 $ 36,513 $ 47,380 $ 3,726 Cash, cash equivalents and investments consisted of the following at December 31, 2018 (in thousands): Cost Gross Unrealized Gains Gross Unrealized Losses Other- Than- Temporary Impairment Losses Fair Value Cash and Cash Equivalents Short-term Investments Long-term Investments Cash and cash equivalents $ 18,773 $ — $ — $ — $ 18,773 $ 18,773 $ — $ — Money market securities 6,389 — — — 6,389 6,389 — — Marketable securities: Certificates of deposit 10,967 — — — 10,967 — 8,437 2,530 Commercial paper 11,468 — — — 11,468 5,890 5,578 — Corporate securities 35,393 — (89 ) — 35,304 500 33,356 1,448 Federal agency securities 19,470 — (124 ) — 19,346 — 15,396 3,950 Municipal securities 1,365 — (6 ) — 1,359 — 1,359 - Total marketable securities 78,663 — (219 ) — 78,444 6,390 64,126 7,928 Preferred stock 518 — — — 518 — — 518 $ 104,343 $ — $ (219 ) $ — $ 104,124 $ 31,552 $ 64,126 $ 8,446 The amortized cost and estimated fair value of the marketable securities by maturity, are shown below (in thousands): As of March 31, 2019 As of December 31, 2018 Amortized Cost Fair Value Amortized Cost Fair Value Marketable securities: Due in one year or less $ 50,995 $ 50,918 $ 70,667 $ 70,517 Due after one year through 5 years 3,229 3,207 7,996 7,927 Due after 5 years through 10 years — — — — Due after 10 years — — — — $ 54,224 $ 54,125 $ 78,663 $ 78,444 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): As of March 31, 2019 As of December 31, 2018 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 $ 6,836 $ (3 ) $ 8,366 $ (28 ) $ 16,075 $ (16 ) $ 17,985 $ (73 ) Federal agency securities 998 — 12,431 (68 ) 3,727 (1 ) 14,625 (122 ) Municipal securities — — 1,350 (2 ) — 0 1,359 (7 ) $ 7,834 $ (3 ) $ 22,147 $ (98 ) $ 19,802 $ (17 ) $ 33,969 $ (202 ) 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. We did not have any unrealized gains or losses or decline in values judged to be other than temporary during the three months ended March 31, 2019. |
Fair Value Measurement
Fair Value Measurement | 3 Months Ended |
Mar. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurement | 4. Fair Value Measurement FASB ASC Topic 820, “Fair Value Measurement”, defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. It also establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows: Level 1: Observable inputs such as quoted prices in active markets; Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions. At March 31, 2019 and December 31, 2018, we held short-term and long-term investments, as discussed in Note 3, Short-Term and Long-Term Investments Property and Equipment, Net Our assets and liabilities subject to the disclosure requirements of ASC 820 at March 31, 2019, were as follows (in thousands): Fair Value Measurement at Reporting Date Total Quoted Prices in active Markets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Gains (Losses) Recurring fair value measurements Marketable securities: Certificates of deposit $ 9,044 $ — $ 9,044 $ — $ — Commercial paper 7,068 — 7,068 — — Corporate securities 20,250 — 20,250 — — Federal agency securities 16,413 — 16,413 — — Municipal securities 1,350 — 1,350 — — Total recurring fair value measurements $ 54,125 $ — $ 54,125 $ — $ — Nonrecurring fair value measurements Property and equipment (see Note 6) $ — $ — $ — $ — $ (129 ) Our assets and liabilities subject to the disclosure requirements of ASC 820 at December 31, 2018, were as follows (in thousands): Fair Value Measurement at Reporting Date Total Quoted Prices in active Markets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Gains (Losses) Recurring fair value measurements Marketable securities: Certificates of deposit $ 10,967 $ — $ 10,967 $ — $ — Commercial paper 11,468 — 11,468 — — Corporate securities 35,304 — 35,304 — — Federal agency securities 19,346 — 19,346 — — Municipal securities 1,359 — 1,359 — — Total recurring fair value measurements $ 78,444 $ — $ 78,444 $ — $ — Nonrecurring fair value measurements Property and equipment (see Note 6) $ — $ — $ — $ — $ (1,487 ) |
Inventories, Net
Inventories, Net | 3 Months Ended |
Mar. 31, 2019 | |
Inventory Disclosure [Abstract] | |
Inventories, Net | 5. Inventories, net Inventories are stated at lower of cost or NRV. Cost, which includes amounts related to materials and costs incurred by our contract manufacturers, is determined on a first-in, first-out basis. Inventories are reviewed periodically for potential excess, dated or obsolete status. Management evaluates the carrying value of inventories on a regular basis, taking into account such factors as historical and anticipated future sales compared to quantities on hand, the price we expect to obtain for products in their respective markets compared with historical cost and the remaining shelf life of goods on hand. The components of inventories, net of allowances, are as follows (in thousands): As of As of March 31, 2019 December 31, 2018 Finished goods $ 1,437 $ 2,489 Work-in-process 3,661 3,542 Raw materials and supplies 2,148 2,577 Total inventories 7,246 8,608 Plus: non-current raw materials and finished goods 2,667 4,330 $ 9,913 $ 12,938 As of March 31, 2019 and December 31, 2018, raw materials inventories consisted of raw materials used in the manufacture of the dronabinol API for SYNDROS® in our U.S.-based, state-of-the-art dronabinol manufacturing facility, the fentanyl API for SUBSYS®, and component parts and packaging materials used in the manufacture of both SUBSYS® and SYNDROS®. Work-in-process consisted of actual production costs, including facility overhead and tooling costs of in-process dronabinol, SUBSYS® and SYNDROS® products. Finished goods inventories consisted of finished SUBSYS® and SYNDROS® products. Non-current raw materials and finished goods represent those inventories not expected to be consumed or sold within 12 months of the balance sheet date and are included in other assets in our unaudited condensed consolidated balance sheets. As of March 31, 2019 and December 31, 2018, all work-in-process inventory is expected to be used within 12 months of the balance sheet date and, therefore, is classified as current assets in our unaudited condensed consolidated balance sheets. We maintain an allowance for excess and obsolete inventory, as well as inventory where its cost is in excess of its NRV. Inventories at March 31, 2019 and December 31, 2018, were reported net of these reserves of $5,561,000 and $2,938,000, respectively. During the three months ended March 31, 2019, we increased these reserves by approximately $1,521,000, partially offset by a decrease of $207,000 for the destruction of previously reserved product. During the three months ended March 31, 2018, we decreased these reserves by approximately $5,000,000 for the destruction of previously reserved product, partially offset by an increase to the reserves of approximately $500,000. |
Property and Equipment, Net
Property and Equipment, Net | 3 Months Ended |
Mar. 31, 2019 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment, Net | 6. Property and Equipment, Net Property and equipment are recorded at cost and depreciated using the straight-line method over their estimated useful lives; leasehold improvements are recorded at cost and depreciated using the straight-line method over the shorter of their estimated useful lives or remaining lease term. Maintenance and repairs that do not extend the life of assets are charged to expense when incurred. When property and equipment is disposed of, the related costs and accumulated depreciation are removed from the unaudited condensed consolidated balance sheets, and any gain or loss is reported in other income (expense) in the period the transaction takes place. During the three months ended March 31, 2019 and 2018, we recorded losses on the disposal of property and equipment of $851,000 and $108,000, respectively. Property and equipment are reviewed for impairment whenever events or changes in circumstances indicate the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to estimated undiscounted cash flows expected to be generated by the asset. If the carrying amount exceeds its estimated future undiscounted cash flows, an impairment charge is recognized by the amount by which the carrying amount exceeds the fair value of the asset. The fair value is measured on a nonrecurring basis using unobservable (Level 3) inputs. Impairment charges are reported in the period the impairment is identified. During the three months ended March 31, 2019, we recorded impairment charges in research and development of $129,000. The charge during the three months ended March 31, 2019 was the result of operating failures of equipment that had a cost of $171,000 and accumulated depreciation of $42,000. The equipment had little or no scrap value due to its specialized nature, and was written down to its estimated fair value of $0. There were no such charges during the three months ended March 31, 2018. |
Leases
Leases | 3 Months Ended |
Mar. 31, 2019 | |
Leases [Abstract] | |
Leases | 7. Leases As discussed in Note 1, we adopted the requirements of the new lease standard on January 1, 2019. Prior to January 1, 2019, we accounted for leases in accordance with ASC Topic 840, Leases Our operating lease portfolio consists of building leases. We lease office and lab space in Chandler, Arizona and Round Rock, Texas, under lease agreements that expire between June 2021 and February 2032. We have the option to extend our primary manufacturing facility operating lease for two 5-year periods following the February 2032 expiration date. We have the option the extend a second operating lease for one 5-year period following the June 2021 expiration date. Neither of these optional renewal periods have been included in the operating ROU assets or operating lease liabilities on our unaudited condensed consolidated financial statements. We have the option to extend a third operating lease on an annual basis through January 2022, and this renewal option has been included in the operating ROU assets and operating lease liabilities on our unaudited condensed consolidated financial statements. Our primary manufacturing facility lease requires us to maintain an irrevocable letter of credit in the amount of $267,000 during the term of the lease and up to 30 days after the expiration date. Our operating lease expense for the three months ended March 31, 2019 was $721,000. Cash paid for amounts included in the measurement of operating lease liabilities was $755,000 for the three months ended March 31, 2019. Lease expense recorded under Topic 840 for the three months ended March 31, 2018 was $1,007,000. As of March 31, 2019, the weighted average remaining lease term of our operating leases is 8.4 years, and the weighted average discount rate of our operating leases is 9.25%. The maturities of our operating lease liabilities under Topic 842 as of March 31, 2019 are as follows (in thousands): Years ending December 31, Remainder of 2019 $ 2,289 2020 3,128 2021 2,340 2022 1,283 2023 1,295 Thereafter 11,851 Total operating lease payments 22,186 Less: imputed interest 8,184 Total current and non-current operating lease liabilities $ 14,002 The future minimum commitments of our operating leases under Topic 840 as of December 31, 2018 are as follows (in thousands): Years ending December 31, 2019 $ 3,044 2020 3,128 2021 2,340 2022 1,283 2023 1,295 Thereafter 11,851 Total operating lease payments $ 22,941 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 8 . Commitments and Contingencies Legal Matters Other than the matters that we have disclosed below, we from time to time become involved in various ordinary course legal and administrative proceedings, which include intellectual property, commercial, governmental and regulatory investigations, employee-related issues and private litigation, which we do not currently believe are either individually or collectively material. We record accruals for contingencies when it is probable that a liability has been incurred and the amount can be reasonably estimated. These accruals are adjusted periodically as assessments change or additional information becomes available. If the reasonable estimate of a probable loss is a range, and no amount within the range is a better estimate, the minimum amount in the range is accrued. If a loss is not probable or a probable loss cannot be reasonably estimated, no liability is recorded. We have established reserves for certain of our legal matters. Our loss estimates are generally developed in consultation with outside counsel and outside accounting experts and are based on analyses of potential outcomes. As legal and governmental proceedings, disputes and investigations are inherently unpredictable and in part, beyond our control, unless otherwise indicated, we cannot reasonably predict the outcome of these legal proceedings, nor can we estimate the amount of loss, or range of loss, if any, that may result from these proceedings. While our liability in connection with certain claims cannot be currently estimated, the resolution in any reporting period of one or more of these matters could have a significant impact on our consolidated financial condition, results of operations, liquidity, and cash flows for that future period, and could ultimately have a material adverse effect on our consolidated financial position and could cause the market value of our common shares to decline. While we believe we have valid defenses in these matters, litigation and governmental and regulatory investigations are inherently uncertain, and we may in the future incur material judgments or enter into material settlements of claims. Consistent with the practice of many publicly-traded companies, we have entered into, and continue to enter into, indemnity agreements with our executive officers and certain members of our board of directors. These indemnity agreements broadly provide for us to advance expenses (including attorneys’ fees) incurred in connection with any legal proceeding, as well as indemnification for any and all expenses, actually and reasonably incurred, in connection with the investigation, defense, settlement or appeal of such a proceeding, in connection with matters related to their position. These indemnity agreements provide that the indemnitee shall repay all amounts so advanced if it shall ultimately be determined by final judicial decision from where there is no further right of appeal that the indemnitee is not entitled to be indemnified. Government Proceedings Like other companies in the pharmaceutical industry, we are subject to extensive regulation by national, state and local government agencies in the United States. As a result, interaction with government agencies occurs in the normal course of our operations. The following is a brief description of pending governmental investigations that we believe are potentially or actually material at this time. It is possible that criminal charges and substantial payments, fines and/or civil penalties or damages or exclusion from federal healthcare programs or other administrative actions, as well as a corporate integrity agreement, deferred prosecution or deferred exclusion agreement, or similar government mandated compliance document that institutes significant restrictions or obligations, could result for us from any government investigation or proceeding. In addition, even certain investigations that are not discussed below and which we do not deem to be material at this time could be determined to be material and could have a material adverse effect on our financial condition, results of operations and cash flows. HHS Investigation . We received a subpoena, dated December 9, 2013, from the OIG in connection with an investigation of potential violations involving HHS programs. This subpoena was issued in connection with an investigation by the U.S. Attorney’s Office for the Central District of California and requested documents regarding our business, including the commercialization of SUBSYS®. We continue to cooperate with this investigation and have produced substantial documents in response to the subpoena and have provided other requested information. On April 13, 2018, the United States intervened in part and declined to intervene in part in five lawsuits: United States ex rel. Guzman v. Insys Therapeutics, Inc. United States ex rel Doe v. Insys Therapeutics, Inc. United States ex rel. Andersson v. Insys Therapeutics, Inc. United States ex rel. Erickson v. Insys Therapeutics, Inc. United States ex rel. Doe v. Insys Therapeutics, Inc. The States of California, Colorado, Indiana, Minnesota, New York, North Carolina, and Virginia (the “Plaintiff States”) elected to intervene in part and declined to intervene in part in United States ex rel. Guzman v. Insys Therapeutics, Inc. United States ex rel. Doe v. Insys Therapeutics, Inc. The United States’ Complaint in Intervention, which was ordered unsealed on May 11, 2018, brings claims for False Claims Act: Presentation of False Claims pursuant to 31 U.S.C. § 3729(a)(1)(A), False Claims Act: Using False Statements to Get False Claims Paid pursuant to 31 U.S.C. § 3729(a)(1)(B), Payment by Mistake, and Unjust Enrichment. This case is currently stayed, and we continue to have ongoing discussion with respect to the DOJ Investigation (as discussed below). The qui tam HIPAA Investigation . On September 8, 2014, we received a subpoena issued pursuant to HIPAA from the U.S. Attorney’s Office for the District of Massachusetts. The subpoena requested documents regarding SUBSYS®, including our sales and marketing practices related to this product. This investigation also relates to activities in our patient services hub. We continue to cooperate with this investigation and have produced a substantial number of documents in response to the subpoena and have provided other requested information. DOJ Investigation and Agreement in Principle . We collectively refer to the HHS and HIPAA investigations discussed above as the “DOJ Investigation.” In connection with our cooperation, we have been engaged in discussions with the DOJ about these matters, including a resolution of potential liability exposure. Management accrued, as of September 30, 2017, an aggregate of $150,000,000, which represented our best estimate of the minimum liability exposure that we expected to be paid out over five years in connection with the DOJ Investigation. This estimate reflected a minimum exposure at which management had determined a willingness to settle these matters. The accrual was recorded in accrued litigation award and settlements on our consolidated balance sheets and as an operating expense on our consolidated statements of operations and comprehensive income (loss). On August 8, 2018, we announced that we reached an agreement in principle with the DOJ to settle the DOJ’s civil and criminal investigation into inappropriate sales and commercial practices by some former company employees. Our initial estimate of the minimum liability exposure we previously accrued in connection with the DOJ Investigation of $150,000,000 expected to be paid over five years remains unchanged as of December 31, 2018, with the potential for contingency-based payments associated with certain events that, if they were to occur, management estimates would require additional payments ranging from $0 to $75,000,000. For the three months ended March 31, 2019, we accrued interest expense in connection with the DOJ Investigation of approximately $1,063,000, which is recorded in charges related to litigation award and settlements in these unaudited condensed consolidated statements of operations and comprehensive income (loss). This agreement in principle is subject to the negotiation of final settlement documents with the government. We are uncertain if the Company will be able to complete a final settlement with the DOJ because of the Company’s inability to fulfill demands made by the DOJ, including the execution of a security agreement relating to the assets of the Company to collateralize payments under the settlement. We expect that a final settlement, if it were to be completed, would include other material non-financial terms and conditions, including a fraud-based criminal felony plea by one of our subsidiaries and a deferred prosecution agreement with the Company related to the actions of our former employees. Additionally, we expect that a final settlement, if it were to be completed, will include a corporate integrity agreement and conditional exclusion release between the Company and OIG that will require the Company to exit the opioid business within 12 months of the effective date, in addition to other provisions. If executed, these agreements will require continued cooperation with the federal government’s prosecutions, enhancements to our compliance program, fulfillment of reporting and monitoring obligations, and management certifications, among other requirements. In addition, compliance with the terms of these agreements will impose additional costs and burdens on us, including some form of employee training, third party reviews, compliance monitoring, reporting obligations and management attention. More importantly, if we fail to comply with the final agreement with DOJ and OIG, the DOJ or OIG may impose substantial monetary penalties or exclude us from federal healthcare programs, including Medicare, Medicaid or the VA, which would have a material adverse effect on our business, financial condition and results of operations. Because other material, non-financial terms and conditions remain subject to the negotiation of final settlement documents, we cannot provide assurances as to the timing of the execution of final documentation and, like any pending negotiation, there is uncertainty as to the outcome. Moreover, any such final settlement is likely to involve entry into final agreements, which will impose significant costs and burdens and obligations on our business operations and could materially and adversely affect our results of operations and financial conditions as we implement and adhere to such requirements. Failure to enter into a settlement agreement with the DOJ will likely result in the indictment of the Company by the U.S. Government. At this time, the aforementioned accrual does not currently meet the more likely than not standard to recognize a tax benefit; therefore, we have recognized no tax benefit for it in these unaudited condensed consolidated financial statements. It is possible that some or all of this accrual may meet the more likely than not standard in the future, at which time a tax benefit would be recognized. SEC Investigation . On January 11, 2018, the SEC's Los Angeles Regional office requested that the Company voluntarily provide information on the Company's: (1) restatement of the Company’s interim unaudited condensed consolidated financial statements as of and for the quarters ended September 30, June 30, and March 31, 2016 and 2015, filed on April 7, 2017; (2) sales and marketing practices; and (3) compliance program, internal controls and enhancements thereto. The Company provided such information and cooperated with the SEC's investigation, including responding to requests or demands for documents and other information. On October 4, 2018, the SEC notified the Company in writing that it had concluded its investigation and, based on information as of the date of the notification, it does not intend to recommend an SEC enforcement action against the Company. Healthcare Professionals and Former Employees Related Investigations. Investigations of Healthcare Professionals. A number of healthcare practitioners who formerly interacted with our Company are under investigation or have been charged in criminal proceedings. In addition to the below investigations that are specifically directed at us, we have received governmental agency requests for information, including subpoenas, from at least the following governmental bodies: the USAO and/or HHS OIG of California (Los Angeles), Central District of California, Colorado, Connecticut, Eastern District of Michigan, Eastern District of New York, Florida (Jacksonville), Kansas, Middle District of Florida, Middle District of Pennsylvania, New Hampshire, New Jersey, Northern District of California, Northern District of Georgia, Northern District of Texas, Rhode Island, Southern District of Alabama, Southern District of New York, Southern District of Ohio, Western District of New York, and the states of Arizona, Delaware, Maryland and New York, regarding specific healthcare professionals with which we have interacted with in those states. In addition, at least the following healthcare practitioners formerly interacting with our Company have been charged as follows: On or about June 23, 2015, a nurse practitioner located in Connecticut, who served on our speaker bureau in connection with our speaker programs designed to educate and promote product awareness and safety for external healthcare providers, pled guilty to violating the federal Anti-Kickback Statute in connection with payments of approximately $83,000 from us. On or about November 7, 2016, a healthcare professional located in Michigan who served on our speaker bureau pled guilty to healthcare fraud in connection, in part, with receiving payments from us. On February 23, 2017, two Alabama healthcare professionals who served on our speaker bureau were convicted on 19 of 20 counts brought against them, which included charges related to distribution of a controlled substance, drug conspiracy, healthcare fraud conspiracy and money laundering. On or about March 22, 2017, the U.S. Attorney’s Office for the District of New Hampshire filed an indictment against a physician assistant, who served on our speaker bureau, charging him with violating the federal Anti-Kickback Statute and conspiring to violate the federal Anti-Kickback Statute in connection with payments received for serving as an Insys promotional speaker. On December 18, 2018, a jury convicted the physician assistant on all seven counts. On or about October 20, 2017, a healthcare professional in Rhode Island, who served on our speaker bureau pled guilty to healthcare fraud and conspiracy to receive kickbacks in connection with payments of approximately $188,000 from us. On or about March 14, 2018, the U.S. Attorney’s Office for the Southern District of New York filed an indictment against five healthcare professionals who served on our speaker bureau, charging them with conspiracy to violate the federal Anti-Kickback Statute, violation of the federal Anti-Kickback Statute, and conspiracy to commit honest services fraud, and charged certain of them with aggravated identity theft, false statements, and wrongful disclosure of individually identifiable health information. On or about June 4, 2018, a Florida healthcare professional who served on our speaker bureau pled guilty to conspiracy to receive healthcare kickbacks in connection, in part, with receiving payments from us. On or about June 28, 2018, an Ohio healthcare professional who served on our speaker bureau was indicted for violating the federal Anti-Kickback Statute in connection with receiving payments of more than $103,000 from us. Investigations of Former Employees. A number of our former employees have been charged in criminal proceedings related to our federal investigations and the following is certain information related thereto. On or about February 18, 2016, one of our former sales employees located in Alabama pled guilty to a conspiracy to violate the federal Anti-Kickback Statute in connection with two convicted Alabama healthcare professionals mentioned above. On or about April 23, 2018, the former sales employee was sentenced to six months’ home confinement. On or about June 8, 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 healthcare professionals who prescribed our product and served on our speaker bureau. On June 1, 2017, the former district sales manager was charged in a superseding indictment with additional charges of honest services wire fraud and aggravated identity theft in connection with falsifying sign-in sheets for our speaker programs. On or about March 16, 2018, records were unsealed indicating that the two former employees each pled guilty to the following counts contained in a superseding indictment: conspiracy to violate the Anti-Kickback Statue, violation of the Anti-Kickback Statue, violation of HIPAA, conspiracy to commit honest services wire fraud, and aggravated identity theft, and that the former sales representative also pled guilty to healthcare fraud. On or about December 8, 2016, the U.S. Attorney’s Office for the District of Massachusetts issued an indictment against six former employees, including Michael L. Babich, our former President, CEO and director, on charges including racketeering conspiracy, conspiracy to commit mail fraud, conspiracy to commit wire fraud, conspiracy to violate the Anti-Kickback Statute and forfeiture (the “Original Indictment”). On or about October 26, 2017, the U.S. Attorney’s Office for the District of Massachusetts issued a superseding indictment in connection with the Original Indictment and added charges against our former President, CEO and director, Dr. John N. Kapoor. After Dr. Kapoor’s indictment, he agreed to put his ownership of our common stock in a trust to be controlled independently, which was effective as of February 27, 2018. The related voting trust agreement was filed with the SEC on a Current Report on Form 8-K on March 1, 2018. On September 11, 2018, the U.S. Attorney’s Office for the District of Massachusetts filed a second superseding indictment which contained one count of racketeering conspiracy for all the defendants. This superseding indictment includes a request for forfeiture upon conviction of any interest or property acquired or maintained in violation of such charges, which expressly includes any and all shares of the Company’s common stock or options to purchase such stock, salaries, bonuses and other benefits. On or around November 28, 2018, Alec Burlakoff pleaded guilty to the racketeering conspiracy count in the second superseding indictment. On or around January 9, 2019, Michael L. Babich pleaded guilty to one count of conspiracy to commit violations of (a) 18 U.S.C. § 1341 (mail fraud) and (b) 18 U.S.C. § 1343 (wire fraud) and one count of mail fraud; aiding and abetting (18 U.S.C. §§ 1341 and 1342). On May 2, 2019, Dr. Kapoor and the four other former employees were convicted on the racketeering conspiracy count in the second superseding indictment. As prescribed by the indemnity agreements we entered into with these former executives, we are responsible for any and all expenses, actually and reasonably incurred in their defense, subject to certain limitations set forth in the indemnity agreements. We have recognized expenses associated with the criminal and civil defense of Dr. Kapoor of approximately $18,100,000 for the three months ended March 31, 2019. As of March 31, 2019, we have reported $38,100,000 in accrued legal expense in the accompanying unaudited condensed consolidated balance sheet as of March 31, 2019. The Company is disputing the reasonableness of a portion of these expenses as they relate to the criminal defense and is analyzing the reasonableness of the civil defense expenses. We continue to accrue all of these costs in our unaudited condensed consolidated statements of operations and comprehensive income (loss). During the three months ended March 31, 2019, the Company made cash payments of $1,800,000 related to these legal expenses incurred as part of Dr. Kapoor’s criminal defense. If such disputed amounts are subsequently determined not to be due and payable, we would recognize a reversal of these expenses in a future period. The reversal of these expenses could have a material impact on our unaudited condensed consolidated statements of operations and comprehensive income (loss). If it is subsequently determined that all of these costs are reasonable, and the Company is required to pay the remaining balance, this could have a material adverse impact on our cash position and liquidity. Consistent with the terms of the indemnity agreement, if Kapoor’s criminal conviction is upheld on appeal, it is expected that the Company will seek to claw back all sums paid pursuant to that agreement. On or about February 8, 2017, a former district sales manager in the Northeast was charged in federal court in New Haven, Connecticut, with violating the federal Anti-Kickback Statute in connection with interacting with healthcare professionals who prescribed our product and served on our speaker bureau. On August 8, 2018, the former district sales manager pleaded guilty to engaging in a kickback scheme that defrauded federal healthcare programs. On April 5, 2017, the U.S. Attorney’s Office for the District of Massachusetts filed an information charging a former prior authorization specialist and manager of our patient services hub with one count of wire fraud conspiracy; the former employee pled guilty to that information on June 19, 2017. On or about July 11, 2017, a former district sales manager pled guilty to conspiring to violate the federal Anti-Kickback Statute related to her activities in the Southern District of Alabama, as well as the Middle and Southern Districts of Florida, including in connection with the two convicted Alabama healthcare professionals mentioned above. On or about May 30, 2018, a former specialty sales professional pled guilty to a second-degree charge of conspiracy to commit commercial bribery related to her activities in New Jersey. Except as otherwise indicated, we understand that each of these indicted individuals have entered pleas of not guilty to the charges against them. Given the ongoing investigations related to our Company and former employees, as well as other individuals associated with our Company, including healthcare professionals, it is possible that additional individual or company criminal charges and convictions and pleas could result from our ongoing federal and state government investigations and related proceedings and the foregoing disclosure and the disclosure below is merely intended to provide general insight into the comprehensive nature of the scope and breadth of investigations that are being conducted related to our Company and is not, nor is it intended to be, an exhaustive listing of every charge, conviction or pleading in connection with our Company. Ongoing State-Related Investigations . We have received CIDs or subpoenas, as the case may be, from at least each of the following state’s Office of the Attorney General (or similarly named and authorized office) which have ongoing investigations directed at our Company: Arizona, Colorado, Florida, Kansas, Kentucky, Maryland, Minnesota, Missouri, New Jersey, New York, North Carolina, Pennsylvania, Rhode Island, Virginia, Washington, and Wisconsin. Moreover, we have received an administrative subpoena from the California Insurance Commissioner. In addition, we understand that numerous physicians practicing within several of the aforementioned states have received subpoenas from certain state Attorney General or Department of Justice offices in connection with interactions with us. Generally, these CIDs and subpoenas request documents regarding SUBSYS®, including our sales and marketing practices related to SUBSYS® in the applicable state, as well as our patient services hub. We are cooperating with each of these investigations and have produced, or anticipate producing, documents in response to these CIDs, subpoenas and related requests for information from each office. In an effort to reach a global resolution of all claims brought by, or that could be brought by, state Attorneys General (or similarly named and authorized offices), we have engaged in preliminary discussions with a multistate group of Attorneys General. Ongoing Complaints filed in connection with State Related Investigations In connection with the investigation by the State of Arizona, on August 30, 2017, the Arizona Attorney General filed a complaint on behalf of the State of Arizona against us in the Maricopa County, Arizona Superior Court. The complaint asserts claims for violations of the Arizona Consumer Fraud Act in connection with the sales and marketing of SUBSYS® in Arizona and in connection with our patient services hub. The complaint seeks a permanent injunction preventing us from engaging in practices in violation of the Arizona Consumer Fraud Act, restitution to consumers and other persons, disgorgement of profits, civil penalties, and investigative costs. On or about November 10, 2017, we filed a motion to dismiss. On January 17, 2018, the Court dismissed, based upon preemption by the federal Sunshine Act, the State’s claim to the extent related to remedies that are based upon the payment and disclosure of speaker fees, but did not dismiss the rest of the complaint. The State filed a motion for leave to amend its complaint, which the Court granted. We filed our answer to the amended complaint on April 5, 2018. In connection with the investigation by the State of New Jersey, on October 5, 2017, the New Jersey Attorney General, on behalf of the State of New Jersey, and the Acting Director of the New Jersey Division of Consumer Affairs filed a complaint against us in the Superior Court of New Jersey, Chancery Division, Middlesex Vicinage. The complaint asserts claims for violations of the New Jersey Consumer Fraud Act and for violations of the New Jersey False Claims Act in connection with the sales and marketing of SUBSYS® in New Jersey and in connection with our patient services hub. The complaint seeks a permanent injunction preventing us from engaging in practices in violation of the New Jersey Consumer Fraud Act, disgorgement of profits, civil penalties, treble damages for alleged violations of the New Jersey False Claims Act, and costs and attorneys’ fees. On November 16, 2017, the New Jersey Attorney General filed an Amended Complaint, which we moved to dismiss on January 8, 2018. The New Jersey Attorney General opposed our motion on March 28, 2018, and we replied. On December 19, 2018, the Court denied our motion to dismiss. On December 21, 2017, Attorney General of the State of North Carolina filed a complaint in Wake County, North Carolina Superior Court against us. The complaint asserts claims related to alleged violations of the North Carolina Consumer Protection Act. On or about September 25, 2018, we moved to dismiss the complaint. The motion remains pending. On February 1, 2018, the Attorney General of the State of New York, filed a complaint against us in the Supreme Court of the State of New York, County of New York. The complaint asserts claims related to alleged deceptive acts and practices. We moved to dismiss the complaint on April 18, 2018. In response, on May 25, 2018, the New York Attorney General opposed our motion to dismiss and filed a cross-motion for partial summary judgment related to the State’s commercial bribery claim. On June 29, 2018, we filed a reply in support of our motion to dismiss and opposed the State’s motion for partial summary judgment. The Court conducted oral argument on the motions to dismiss and the cross-motion for summary judgement on October 4, 2018, and subsequently denied both motions. On February 5, 2018, the Consumer Protection Division, Office of the Attorney General of Maryland, filed a petition to enforce an administrative subpoena against us. The State voluntarily dismissed the action on September 5, 2018. On September 6, 2018, however, the Consumer Protection Division, Office of the Attorney General of Maryland, filed a Statement of Charges against us with the Consumer Protection Division, Office of the Attorney General. Insys filed its response to the Statement of Charges on October 17, 2018. On November 21, 2018, Insys filed a Motion to Dismiss the Statement of Charges. On January 31, 2019, the Administrative Law Judge issued a Proposed Ruling on Motion to Dismiss Statement of Charges in which he recommended that the Consumer Protection Division deny the Motion to Dismiss. The merits hearing is scheduled to begin in August 2019. On May 30, 2018, the Attorney General of the State of Minnesota and the Minnesota Board of Pharmacy filed a complaint against us in the Hennepin County District Court, State of Minnesota. The complaint asserts claims related to alleged deceptive acts and practices and consumer fraud, as well as claims under the Minnesota Wholesale Drug Distribution Licensing Act (Minn. Stat. § 151.461). On August 28, 2018, Insys moved to dismiss the complaint. On the same day, the Attorney General and the Board of Pharmacy filed a motion for temporary injunction. The Court held oral argument on both the motion to dismiss and the motion for temporary injunction, and the Court denied both motions on January 15, 2019. Also, on May 30, 2018, the Minnesota Board of Pharmacy filed an administrative action against us before the State of Minnesota Office of Administrative Hearings for the Board of Pharmacy, which seeks a determination regarding whether certain alleged conduct by Insys constitutes grounds for disciplinary action. The Office of Administrative Hearings has set a hearing in this matter for September 2019. On November 19, 2018, the Attorney General of the Commonwealth of Kentucky filed a complaint against us in the Hardin County Circuit Court, Commonwealth of Kentucky. The complaint asserts claims related to alleged violations of the Kentucky Consumer Protection Act, as well as Medicaid and Kentucky Assistance Program Fraud, public nuisance, fraud, unjust enrichment, negligence, negligence per se, and punitive damages. On January 16, 2019, Insys moved to dismiss the complaint. The motion remains pending. Management accrued, as of March 31, 2019, an aggregate of $48,000,000, which represents our best estimate of the minimum liability exposure that we expect to be paid out in connection with the potential settlement of current claims or potential future claims by various states, as discussed above. We estimate that the range of potential loss related to these matters is between $48,000,000 and $130,000,000. The accrual was recorded in accrued litigation award and settlements on the unaudited condensed consolidated balance sheets and as an operating expense on the unaudited condensed consolidated statements of operations and comprehensive loss. Multi-District Prescription Opioid Litigation . We have been named along with various other opioid manufacturers, opioid distributors, prescribers, pharmacies, and others in complaints focused on the national opioid epidemic filed by various cities, counties, states, Native American tribes, and third-party payers in many state and federal courts in Alabama, Arizona, Arkansas, California, Connecticut, Florida, Georgia, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah and West Virginia. We are involved in more than 800 of these cases, the majority of which have been consolidated into multi-district litigation (MDL No. 2804) in the Northern District of Ohio. Most of the cases in the multi-district litigation are presently stayed while the Court seeks to facilitate a resolution. On April 2, 2018, the United States filed a motion to participate in settlement discussions and as a friend of the court. Additionally, the Court set certain cases for a litigation track, and those cases will move forward toward trial, which is scheduled to commence on October 21, 2019. Additionally, the Court recently set another set of c |
Stock-based Compensation
Stock-based Compensation | 3 Months Ended |
Mar. 31, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-based Compensation | 9 . Stock-based Compensation Amounts recognized in the unaudited condensed consolidated statements of operations and comprehensive loss with respect to our stock-based compensation plans were as follows (in thousands): Three Months Ended March 31, 2019 2018 Research and development $ 715 $ 847 General and administrative 2,394 2,323 Total cost of stock-based compensation $ 3,109 $ 3,170 Included in stock-based compensation for the three months ended March 31, 2019 and 2018 was approximately $786,000 and $0, respectively, of expense associated with the accelerated vesting of options awards related to terminated employees. The following table summarizes stock option activity during the three months ended March 31, 2019: Weighted Weighted Average Aggregate Average Remaining Intrinsic Number of Exercise Contractual Value Shares Price Term (in years) (in millions) Vested and exercisable as of December 31, 2018 3,798,636 $ 12.33 6.1 $ 1.2 Outstanding as of December 31, 2018 6,127,202 $ 11.55 Granted 2,543,119 $ 3.94 Cancelled (525,882 ) $ 10.58 Exercised (4,537 ) $ 4.05 Outstanding as of March 31, 2019 8,139,902 $ 9.24 7.6 $ 4.0 Vested and exercisable as of March 31, 2019 4,095,983 $ 12.02 5.9 $ 2.2 As of March 31, 2019, we expected to recognize $15,780,000 of stock-based compensation for outstanding options over a weighted-average period of 2.8 years. From time to time we grant restricted stock units to certain employees and directors. Restricted stock units are valued at the closing market price of our common stock on the day of grant and the total value of the units is recognized as expense ratably over the vesting period of the grants. The following table summarizes restricted stock unit activity during the three months ended March 31, 2019: Weighted Average Grant-Date Number of Fair Value Units Per Unit Outstanding as of December 31, 2018 535,828 $ 9.01 Granted 486,494 $ 4.06 Exercised (127,446 ) $ 9.61 Cancelled (90,749 ) $ 0.69 Outstanding as of March 31, 2019 804,127 $ 2.43 As of March 31, 2019, we expected to recognize $3,671,000 of stock-based compensation for outstanding restricted stock units over a weighted-average period of 2.0 years. Cash received from option exercises under all stock-based payment arrangements for the three months ended March 31, 2019 and 2018 was $18,000 and $524,000, respectively. |
Net Loss per Share
Net Loss per Share | 3 Months Ended |
Mar. 31, 2019 | |
Earnings Per Share [Abstract] | |
Net Loss per Share | 10 . Net Loss per Share Basic net loss per common share is computed by dividing the net loss allocable to the common stockholders by the weighted average number of common shares outstanding during the period. As we have incurred a net loss for the three months ended March 31, 2019 and 2018, basic and diluted per share amounts are the same, since the effect of potential common share equivalents is anti-dilutive. The following table sets forth the computation of basic and diluted net loss per common share (dollars in thousands, except per share amounts): Three Months Ended March 31, 2019 2018 Historical net loss per share - Basic Numerator: Net loss $ (123,844 ) $ (20,370 ) Denominator: Weighted average number of common shares outstanding 74,426,030 73,745,202 Basic net loss per common share $ (1.66 ) $ (0.28 ) Historical net loss per share - Diluted Numerator: Net loss $ (123,844 ) $ (20,370 ) Denominator: Weighted average number of common shares outstanding 74,426,030 73,745,202 Effect of dilutive stock options — — Weighted average number of common shares outstanding 74,426,030 73,745,202 Diluted net loss per common share $ (1.66 ) $ (0.28 ) |
Product Lines, Concentration of
Product Lines, Concentration of Credit Risk and Significant Customers | 3 Months Ended |
Mar. 31, 2019 | |
Segment Reporting [Abstract] | |
Product Lines, Concentration of Credit Risk and Significant Customers | 1 1 . Product Lines, Concentration of Credit Risk and Significant Customers We are engaged in the business of developing and selling pharmaceutical products. During the three months ended March 31, 2019, we had two product lines, SUBSYS® and SYNDROS®. Our CODM evaluates revenues based on product lines. The following tables summarize our net revenue by product line, as well as the percentage of revenue by route to market (in thousands): Net Revenue by Product Line Three Months Ended March 31, 2019 2018 SUBSYS ® $ 7,233 $ 23,274 SYNDROS ® 397 637 Total net revenue $ 7,630 $ 23,911 Percent of Revenue by Route to Market Three Months Ended March 31, 2019 2018 Pharmaceutical wholesalers 61 % 61 % Specialty pharmaceutical retailers 39 % 39 % 100 % 100 % All our products are sold in the United States of America. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2019 | |
Subsequent Events [Abstract] | |
Subsequent Events | 12. Subsequent Events Leadership Changes and Compensation Arrangements On April 14, 2019, Saeed Motahari resigned as President and Chief Executive Officer and Andrew G. Long was appointed as Chief Executive Officer. In connection with these leadership changes, Andrece Housley was appointed as Chief Financial Officer, succeeding Mr. Long, and Dr. Venkat Goskonda was promoted to Chief Scientific Officer, overseeing the Company’s research and development and manufacturing activities. On April 17, 2019, the Company’s Board of Directors approved cash retention bonuses for each of Mr. Long, Chief Executive Officer of the Company; Andrece Housley, Chief Financial Officer of the Company; and Mark Nance, Chief Legal Officer and General Counsel of the Company, in the amounts of $1,100,000, $400,000 and $613,000, respectively. The retention bonuses include certain terms and conditions, including full clawback if any such officer’s employment terminates under certain conditions within twelve months of the agreement date. On April 23, 2019, the Company exercised its authority pursuant to Mr. Motahari’s Employment Agreement via power of attorney to tender his resignation as a director of the Company (in connection with his resignation as Chief Executive Officer). Grant from National Institute on Drug Abuse On May 7, 2019, the Company was awarded a grant from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), for a series of clinical studies designed to evaluate the effects of pharmaceutical-grade cannabidiol (CBD) on craving and relapse prevention in opioid use disorder. The total grant amount is $10.3 million over 5 years and is subject to certain milestones. We will provide the drug required for the studies, R&D expertise and clinical and regulatory support, among other services in kind. Suspension of 2013 Employee Stock Purchase Plan Effective May 10, 2019, the Board of Directors suspended indefinitely the 2013 Employee Stock Purchase Plan (the “ESPP”). |
Nature of Business and Basis _2
Nature of Business and Basis of Presentation (Policies) | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Going Concern Uncertainty | Going Concern Uncertainty As of March 31, 2019, the Company had an accumulated deficit of $459.9 million , negative cash flows of $16.7 million from operating activities for the three months ended March 31, 2019, and significant ongoing legal expenses. While we have no outstanding debt, our available liquidity is limited to $87.6 million in cash and cash equivalents and investments as of March 31, 2019, and we expect to have continued negative cash flows from operating activities. We have experienced recurring and increasing losses from operations over the previous 18 months due to significant declines in the TIRF market and significant legal expenses resulting from the DOJ Investigation and other significant litigation matters to which we are subject (see Note 8 of the notes to our unaudited condensed consolidated financial statements for a discussion of these legal matters). We have estimated liabilities of approximately $240.3 million as of March 31, 2019 for proposed settlements of our various litigation matters, and there are other matters for which we have not been able to determine a reasonable estimated loss. Furthermore, we are uncertain if we will be able to complete a final settlement with the DOJ because of the Company’s inability to fulfill demands made by the DOJ, including the execution of a security agreement relating to the assets of the Company to collateralize payments under the settlement. These factors raise substantial doubt about the Company’s ability to continue as a going concern within one year of the issuance date of these unaudited condensed consolidated financial statements. Management’s plans, in order to meet our operating cash flow requirements, include the pursuit of strategic alternatives related to the sale or licensing of the Company’s assets. On November 5, 2018, we announced that we commenced a process to review strategic alternatives for our portfolio of opioid-related assets, including SUBSYS®, as well as formulations of buprenorphine and the combination of buprenorphine/naloxone. The Company has engaged Lazard Freres & Co. LLC to advise the Company on capital planning and the evaluation of strategic alternatives. There are no assurances that the Company will be successful in implementing a strategic plan for the sale or licensing of its assets in order to address its impending liquidity constraints. If the Company cannot successfully implement its strategic plan for the sale or licensing of its assets, and/or reach an agreement with the DOJ, its liquidity, financial condition and business prospects will be materially and adversely affected. Accordingly, it may be necessary for the Company to file a voluntary petition for relief under Chapter 11 of the United States Bankruptcy Code in order to implement a restructuring. Our Board of Directors has not made any decisions related to any strategic alternatives at this time. |
Recently Adopted Accounting Pronouncements | R ecently Adopted Accounting Pronouncements Effective January 1, 2019, we adopted the requirements of ASU No. 2016-02, “Leases: (Topic 842),” and all related amendments (“new lease standard”). The core principle of the new lease standard 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. We initially applied the new lease standard at the adoption date of January 1, 2019, with no cumulative effect adjustment to retained earnings, and elected all of the practical expedients, with the exception of hindsight to determine the lease term, and combining lease and non-lease components. We have elected not to apply the recognition and measurement requirements of the new lease standard to short-term leases, which are those with terms of twelve months or less with no option or intent to purchase the underlying asset at the term of the lease. We recognize lease payments associated with short-term leases on a straight-line basis over the term of the lease. We have presented additional qualitative and quantitative disclosures regarding the Company’s lease obligations as required upon implementation of ASC 842 in Note 7, Leases Leases Effective January 1, 2019, we adopted ASU No. 2017-08, “Receivables—Nonrefundable Fees and Other Costs (Subtopic 310-20): Premium Amortization on Purchased Callable Debt Securities,” to amend the amortization period for certain purchased callable debt securities held at a premium. The ASU shortens the amortization period for the premium to the earliest call date. Under current U.S. GAAP, entities generally amortize the premium as an adjustment of yield over the contractual life of the instrument. The adoption of this guidance had no impact on our unaudited condensed consolidated financial statements. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In August 2018, the FASB issued ASU No. 2018-13, “Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement,” to improve the effectiveness of disclosures. The amendments remove, modify, and add certain disclosure requirements in Topic 820, “Fair Value Measurement.” The amendments on changes in unrealized gains and losses, the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements, and the narrative description of measurement uncertainty should be applied prospectively for only the most recent interim or annual period presented in the initial fiscal year of adoption. All other amendments should be applied retrospectively to all periods presented upon their effective date. The amendments are effective for fiscal years beginning after December 15, 2019. Early adoption is permitted, including adoption in an interim period. Furthermore, an entity is permitted to early adopt any removed or modified disclosures upon issuance of the update and delay adoption of the additional disclosures until their effective date. We do not expect this amendment to have a material impact on our consolidated financial statements. In June 2016, the FASB issued ASU No. 2016-13, “Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments.” The amendments effected by this ASU affect entities holding financial assets and net investment in leases that are not accounted for at fair value through net income and are effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years, and early adoption is permitted. ASU 2016-13 amends the impairment model to utilize an expected loss methodology in place of the currently used incurred loss methodology, which will result in the timelier recognition of losses. We do not expect this amendment to have a material impact on our consolidated financial statements. |
Short-Term and Long-Term Inve_2
Short-Term and Long-Term Investments (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Schedule Of Investments [Abstract] | |
Summary of Cash, Cash Equivalents and Investments | Cash, cash equivalents and investments consisted of the following at March 31, 2019 (in thousands): Cost Gross Unrealized Gains Gross Unrealized Losses Other- Than- Temporary Impairment Losses Fair Value Cash and Cash Equivalents Short-term Investments Long-term Investments Cash and cash equivalents $ 8,716 $ — $ — $ — $ 8,716 $ 8,716 $ — $ — Money market securities 24,260 — — — 24,260 24,260 — — Marketable securities: Certificates of deposit 9,044 — — — 9,044 — 8,064 980 Commercial paper 7,068 — — — 7,068 3,537 3,531 — Corporate securities 20,279 1 (30 ) — 20,250 — 20,250 — Federal agency securities 16,481 1 (69 ) — 16,413 — 14,185 2,228 Municipal securities 1,352 — (2 ) — 1,350 — 1,350 — Total marketable securities 54,224 2 (101 ) — 54,125 3,537 47,380 3,208 Preferred stock 518 — — — 518 — — 518 $ 87,718 $ 2 $ (101 ) $ — $ 87,619 $ 36,513 $ 47,380 $ 3,726 Cash, cash equivalents and investments consisted of the following at December 31, 2018 (in thousands): Cost Gross Unrealized Gains Gross Unrealized Losses Other- Than- Temporary Impairment Losses Fair Value Cash and Cash Equivalents Short-term Investments Long-term Investments Cash and cash equivalents $ 18,773 $ — $ — $ — $ 18,773 $ 18,773 $ — $ — Money market securities 6,389 — — — 6,389 6,389 — — Marketable securities: Certificates of deposit 10,967 — — — 10,967 — 8,437 2,530 Commercial paper 11,468 — — — 11,468 5,890 5,578 — Corporate securities 35,393 — (89 ) — 35,304 500 33,356 1,448 Federal agency securities 19,470 — (124 ) — 19,346 — 15,396 3,950 Municipal securities 1,365 — (6 ) — 1,359 — 1,359 - Total marketable securities 78,663 — (219 ) — 78,444 6,390 64,126 7,928 Preferred stock 518 — — — 518 — — 518 $ 104,343 $ — $ (219 ) $ — $ 104,124 $ 31,552 $ 64,126 $ 8,446 |
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): As of March 31, 2019 As of December 31, 2018 Amortized Cost Fair Value Amortized Cost Fair Value Marketable securities: Due in one year or less $ 50,995 $ 50,918 $ 70,667 $ 70,517 Due after one year through 5 years 3,229 3,207 7,996 7,927 Due after 5 years through 10 years — — — — Due after 10 years — — — — $ 54,224 $ 54,125 $ 78,663 $ 78,444 |
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): As of March 31, 2019 As of December 31, 2018 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 $ 6,836 $ (3 ) $ 8,366 $ (28 ) $ 16,075 $ (16 ) $ 17,985 $ (73 ) Federal agency securities 998 — 12,431 (68 ) 3,727 (1 ) 14,625 (122 ) Municipal securities — — 1,350 (2 ) — 0 1,359 (7 ) $ 7,834 $ (3 ) $ 22,147 $ (98 ) $ 19,802 $ (17 ) $ 33,969 $ (202 ) |
Fair Value Measurement (Tables)
Fair Value Measurement (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Summary of Assets and Liabilities Measured at Fair Value on Recurring and Nonrecurring Basis | Our assets and liabilities subject to the disclosure requirements of ASC 820 at March 31, 2019, were as follows (in thousands): Fair Value Measurement at Reporting Date Total Quoted Prices in active Markets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Gains (Losses) Recurring fair value measurements Marketable securities: Certificates of deposit $ 9,044 $ — $ 9,044 $ — $ — Commercial paper 7,068 — 7,068 — — Corporate securities 20,250 — 20,250 — — Federal agency securities 16,413 — 16,413 — — Municipal securities 1,350 — 1,350 — — Total recurring fair value measurements $ 54,125 $ — $ 54,125 $ — $ — Nonrecurring fair value measurements Property and equipment (see Note 6) $ — $ — $ — $ — $ (129 ) Our assets and liabilities subject to the disclosure requirements of ASC 820 at December 31, 2018, were as follows (in thousands): Fair Value Measurement at Reporting Date Total Quoted Prices in active Markets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Gains (Losses) Recurring fair value measurements Marketable securities: Certificates of deposit $ 10,967 $ — $ 10,967 $ — $ — Commercial paper 11,468 — 11,468 — — Corporate securities 35,304 — 35,304 — — Federal agency securities 19,346 — 19,346 — — Municipal securities 1,359 — 1,359 — — Total recurring fair value measurements $ 78,444 $ — $ 78,444 $ — $ — Nonrecurring fair value measurements Property and equipment (see Note 6) $ — $ — $ — $ — $ (1,487 ) |
Inventories, Net (Tables)
Inventories, Net (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Inventory Disclosure [Abstract] | |
Schedule of Components of Inventories Net of Allowances | The components of inventories, net of allowances, are as follows (in thousands): As of As of March 31, 2019 December 31, 2018 Finished goods $ 1,437 $ 2,489 Work-in-process 3,661 3,542 Raw materials and supplies 2,148 2,577 Total inventories 7,246 8,608 Plus: non-current raw materials and finished goods 2,667 4,330 $ 9,913 $ 12,938 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Leases [Abstract] | |
Summary of Maturities of Operating Lease Liabilities under Topic 842 | The maturities of our operating lease liabilities under Topic 842 as of March 31, 2019 are as follows (in thousands): Years ending December 31, Remainder of 2019 $ 2,289 2020 3,128 2021 2,340 2022 1,283 2023 1,295 Thereafter 11,851 Total operating lease payments 22,186 Less: imputed interest 8,184 Total current and non-current operating lease liabilities $ 14,002 |
Summary of Future Minimum Commitments for Operating Leases under Topic 840 | The future minimum commitments of our operating leases under Topic 840 as of December 31, 2018 are as follows (in thousands): Years ending December 31, 2019 $ 3,044 2020 3,128 2021 2,340 2022 1,283 2023 1,295 Thereafter 11,851 Total operating lease payments $ 22,941 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Summary of Aggregate Minimum Purchase Commitments and Exclusive Supply Rights | The following table sets forth our aggregate minimum purchase commitments and exclusive supply rights with Aptar under these agreements (in thousands): Years ending December 31, Remainder of 2019 $ 2,000 2020 2,000 2021 2,000 2022 — 2023 — Total $ 6,000 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Amounts Recognized in Unaudited Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) with Respect to Stock-Based Compensation Plans | Amounts recognized in the unaudited condensed consolidated statements of operations and comprehensive loss with respect to our stock-based compensation plans were as follows (in thousands): Three Months Ended March 31, 2019 2018 Research and development $ 715 $ 847 General and administrative 2,394 2,323 Total cost of stock-based compensation $ 3,109 $ 3,170 |
Summary of Stock Option Activity | The following table summarizes stock option activity during the three months ended March 31, 2019: Weighted Weighted Average Aggregate Average Remaining Intrinsic Number of Exercise Contractual Value Shares Price Term (in years) (in millions) Vested and exercisable as of December 31, 2018 3,798,636 $ 12.33 6.1 $ 1.2 Outstanding as of December 31, 2018 6,127,202 $ 11.55 Granted 2,543,119 $ 3.94 Cancelled (525,882 ) $ 10.58 Exercised (4,537 ) $ 4.05 Outstanding as of March 31, 2019 8,139,902 $ 9.24 7.6 $ 4.0 Vested and exercisable as of March 31, 2019 4,095,983 $ 12.02 5.9 $ 2.2 |
Summary of Restricted Stock Unit Activity | The following table summarizes restricted stock unit activity during the three months ended March 31, 2019: Weighted Average Grant-Date Number of Fair Value Units Per Unit Outstanding as of December 31, 2018 535,828 $ 9.01 Granted 486,494 $ 4.06 Exercised (127,446 ) $ 9.61 Cancelled (90,749 ) $ 0.69 Outstanding as of March 31, 2019 804,127 $ 2.43 |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Earnings Per Share [Abstract] | |
Schedule of Computation of Basic and Diluted Net Loss Per Common Share | The following table sets forth the computation of basic and diluted net loss per common share (dollars in thousands, except per share amounts): Three Months Ended March 31, 2019 2018 Historical net loss per share - Basic Numerator: Net loss $ (123,844 ) $ (20,370 ) Denominator: Weighted average number of common shares outstanding 74,426,030 73,745,202 Basic net loss per common share $ (1.66 ) $ (0.28 ) Historical net loss per share - Diluted Numerator: Net loss $ (123,844 ) $ (20,370 ) Denominator: Weighted average number of common shares outstanding 74,426,030 73,745,202 Effect of dilutive stock options — — Weighted average number of common shares outstanding 74,426,030 73,745,202 Diluted net loss per common share $ (1.66 ) $ (0.28 ) |
Product Lines, Concentration _2
Product Lines, Concentration of Credit Risk and Significant Customers (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Segment Reporting [Abstract] | |
Summary of Net Revenue by Product Line | The following tables summarize our net revenue by product line, as well as the percentage of revenue by route to market (in thousands): Net Revenue by Product Line Three Months Ended March 31, 2019 2018 SUBSYS ® $ 7,233 $ 23,274 SYNDROS ® 397 637 Total net revenue $ 7,630 $ 23,911 |
Percentage of Revenue by Route to Market | Percent of Revenue by Route to Market Three Months Ended March 31, 2019 2018 Pharmaceutical wholesalers 61 % 61 % Specialty pharmaceutical retailers 39 % 39 % 100 % 100 % |
Nature of Business and Basis _3
Nature of Business and Basis of Presentation - Additional Information (Details) | 3 Months Ended | |||
Mar. 31, 2019USD ($)ProductLine | Mar. 31, 2018USD ($) | Jan. 01, 2019USD ($) | Dec. 31, 2018USD ($) | |
Nature Of Business [Line Items] | ||||
Number of Product Lines | ProductLine | 2 | |||
Accumulated deficit | $ (459,927,000) | $ (336,083,000) | ||
Negative cash flows from operating activities | (16,659,000) | $ (17,403,000) | ||
Debt outstanding | 0 | |||
Estimated litigation liabilities | 240,300,000 | |||
Total operating lease liabilities | 14,002,000 | $ 14,400,000 | ||
Operating lease right-of-use assets | 11,036,000 | 11,400,000 | ||
Adjustment [Member] | ||||
Nature Of Business [Line Items] | ||||
Deferred rent | (3,000,000) | |||
Tenant improvement allowances | $ (1,400,000) | |||
Maximum [Member] | ||||
Nature Of Business [Line Items] | ||||
Cash and cash equivalents and investments | 87,600,000 | |||
Estimated litigation liabilities | 130,000,000 | |||
Minimum [Member] | ||||
Nature Of Business [Line Items] | ||||
Estimated litigation liabilities | $ 48,000,000 |
Revenue Recognition - Additiona
Revenue Recognition - Additional Information (Details) $ in Millions | 3 Months Ended |
Mar. 31, 2019USD ($) | |
Disaggregation Of Revenue [Line Items] | |
Revenue recognized | $ 0.5 |
SUBSYS [Member] | |
Disaggregation Of Revenue [Line Items] | |
Cash Discount, Percent | 2.00% |
Product Return, Period Prior to Expiration | 6 months |
Product Return, Period After Expiration | 12 months |
SUBSYS [Member] | Minimum [Member] | |
Disaggregation Of Revenue [Line Items] | |
Shelf Life of Product from Date of Manufacture | 36 months |
SUBSYS [Member] | Maximum [Member] | |
Disaggregation Of Revenue [Line Items] | |
Shelf Life of Product from Date of Manufacture | 48 months |
SYNDROS [Member] | |
Disaggregation Of Revenue [Line Items] | |
Product Return, Period Prior to Expiration | 6 months |
Product Return, Period After Expiration | 12 months |
SYNDROS [Member] | Minimum [Member] | |
Disaggregation Of Revenue [Line Items] | |
Shelf Life of Product from Date of Manufacture | 24 months |
SYNDROS [Member] | Maximum [Member] | |
Disaggregation Of Revenue [Line Items] | |
Shelf Life of Product from Date of Manufacture | 36 months |
Short-Term and Long-Term Inve_3
Short-Term and Long-Term Investments - Additional Information (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Dec. 31, 2018 | |
Schedule Of Investments [Line Items] | ||
Reclassifications on available-for-sale securities | $ 0 | |
Cash and cash equivalents, estimated fair value | 36,513,000 | $ 31,552,000 |
Short-term investments, estimated fair value | 47,380,000 | 64,126,000 |
Long-term investments, estimated fair value | 3,726,000 | 8,446,000 |
Unrealized investment gains (losses) | 0 | |
Marketable Securities [Member] | ||
Schedule Of Investments [Line Items] | ||
Cash and cash equivalents, estimated fair value | 3,537,000 | 6,390,000 |
Short-term investments, estimated fair value | 47,380,000 | 64,126,000 |
Long-term investments, estimated fair value | $ 3,208,000 | $ 7,928,000 |
Short-Term and Long-Term Inve_4
Short-Term and Long-Term Investments - Summary of Cash, Cash Equivalents and Investments (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Schedule Of Investments [Line Items] | ||
Cash and cash equivalents, Cost | $ 36,513 | $ 31,552 |
Cash and cash equivalents, Fair Value | 36,513 | 31,552 |
Marketable securities, Cost | 54,224 | 78,663 |
Marketable securities, Gross Unrealized Gains | 2 | |
Marketable securities, Gross Unrealized Losses | (101) | (219) |
Marketable securities, Fair Value | 54,125 | 78,444 |
Short-term Investments | 47,380 | 64,126 |
Long-term Investments | 3,726 | 8,446 |
Cost | 87,718 | 104,343 |
Fair Value | 87,619 | 104,124 |
Commercial Paper [Member] | ||
Schedule Of Investments [Line Items] | ||
Cash and cash equivalents, Fair Value | 3,537 | 5,890 |
Marketable securities, Cost | 7,068 | 11,468 |
Marketable securities, Fair Value | 7,068 | 11,468 |
Short-term Investments | 3,531 | 5,578 |
Corporate Securities [Member] | ||
Schedule Of Investments [Line Items] | ||
Cash and cash equivalents, Fair Value | 500 | |
Marketable securities, Cost | 20,279 | 35,393 |
Marketable securities, Gross Unrealized Gains | 1 | |
Marketable securities, Gross Unrealized Losses | (30) | (89) |
Marketable securities, Fair Value | 20,250 | 35,304 |
Short-term Investments | 20,250 | 33,356 |
Long-term Investments | 1,448 | |
Federal Agency Securities [Member] | ||
Schedule Of Investments [Line Items] | ||
Marketable securities, Cost | 16,481 | 19,470 |
Marketable securities, Gross Unrealized Gains | 1 | |
Marketable securities, Gross Unrealized Losses | (69) | (124) |
Marketable securities, Fair Value | 16,413 | 19,346 |
Short-term Investments | 14,185 | 15,396 |
Long-term Investments | 2,228 | 3,950 |
Municipal Securities [Member] | ||
Schedule Of Investments [Line Items] | ||
Marketable securities, Cost | 1,352 | 1,365 |
Marketable securities, Gross Unrealized Losses | (2) | (6) |
Marketable securities, Fair Value | 1,350 | 1,359 |
Short-term Investments | 1,350 | 1,359 |
Marketable Securities [Member] | ||
Schedule Of Investments [Line Items] | ||
Cash and cash equivalents, Fair Value | 3,537 | 6,390 |
Marketable securities, Cost | 54,224 | 78,663 |
Marketable securities, Gross Unrealized Gains | 2 | |
Marketable securities, Gross Unrealized Losses | (101) | (219) |
Marketable securities, Fair Value | 54,125 | 78,444 |
Short-term Investments | 47,380 | 64,126 |
Long-term Investments | 3,208 | 7,928 |
Preferred Stock [Member] | ||
Schedule Of Investments [Line Items] | ||
Marketable securities, Cost | 518 | 518 |
Marketable securities, Fair Value | 518 | 518 |
Long-term Investments | 518 | 518 |
Cash and Cash Equivalents [Member] | ||
Schedule Of Investments [Line Items] | ||
Cash and cash equivalents, Cost | 8,716 | 18,773 |
Cash and cash equivalents, Fair Value | 8,716 | 18,773 |
Money Market Securities [Member] | ||
Schedule Of Investments [Line Items] | ||
Cash and cash equivalents, Cost | 24,260 | 6,389 |
Cash and cash equivalents, Fair Value | 24,260 | 6,389 |
Certificates of Deposit [Member] | ||
Schedule Of Investments [Line Items] | ||
Marketable securities, Cost | 9,044 | 10,967 |
Marketable securities, Fair Value | 9,044 | 10,967 |
Short-term Investments | 8,064 | 8,437 |
Long-term Investments | $ 980 | $ 2,530 |
Short-Term and Long-Term Inve_5
Short-Term and Long-Term Investments - Summary of Amortized Cost and Estimated Fair Value of Securities by Maturity (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Marketable securities: | ||
Due in one year or less, Amortized Cost | $ 50,995 | $ 70,667 |
Due after one year through 5 years, Amortized Cost | 3,229 | 7,996 |
Marketable securities, Cost | 54,224 | 78,663 |
Due in one year or less, Fair Value | 50,918 | 70,517 |
Due after one year through 5 years, Fair Value | 3,207 | 7,927 |
Marketable securities, Fair Value | $ 54,125 | $ 78,444 |
Short-Term and Long-Term Inve_6
Short-Term and Long-Term Investments - Summary of Gross Unrealized Losses and Fair Value of Investments (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Marketable securities: | ||
Less Than 12 Months Fair Value | $ 7,834 | $ 19,802 |
Less Than 12 Months Unrealized Loss | (3) | (17) |
Greater Than 12 Months Fair Value | 22,147 | 33,969 |
Greater Than 12 Months Unrealized Loss | (98) | (202) |
Corporate Bond Securities [Member] | ||
Marketable securities: | ||
Less Than 12 Months Fair Value | 6,836 | 16,075 |
Less Than 12 Months Unrealized Loss | (3) | (16) |
Greater Than 12 Months Fair Value | 8,366 | 17,985 |
Greater Than 12 Months Unrealized Loss | (28) | (73) |
Federal Agency Securities [Member] | ||
Marketable securities: | ||
Less Than 12 Months Fair Value | 998 | 3,727 |
Less Than 12 Months Unrealized Loss | (1) | |
Greater Than 12 Months Fair Value | 12,431 | 14,625 |
Greater Than 12 Months Unrealized Loss | (68) | (122) |
Municipal Securities [Member] | ||
Marketable securities: | ||
Less Than 12 Months Unrealized Loss | 0 | |
Greater Than 12 Months Fair Value | 1,350 | 1,359 |
Greater Than 12 Months Unrealized Loss | $ (2) | $ (7) |
Fair Value Measurement - Additi
Fair Value Measurement - Additional Information (Details) - Nonrecurring Fair Value Measurements [Member] - USD ($) | Mar. 31, 2019 | Dec. 31, 2018 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets measured at fair value on nonrecurring basis | $ 0 | $ 0 |
Liabilities measured at fair value on nonrecurring basis | $ 0 | $ 0 |
Fair Value Measurement - Summar
Fair Value Measurement - Summary of Assets and Liabilities Measured at Fair Value on Recurring and Nonrecurring Basis (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2019 | Dec. 31, 2018 | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | $ 54,125 | $ 78,444 |
Commercial Paper [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 7,068 | 11,468 |
Corporate Securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 20,250 | 35,304 |
Federal Agency Securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 16,413 | 19,346 |
Municipal Securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 1,350 | 1,359 |
Recurring Fair Value Measurements [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 54,125 | 78,444 |
Recurring Fair Value Measurements [Member] | Certificates of Deposit [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 9,044 | 10,967 |
Recurring Fair Value Measurements [Member] | Commercial Paper [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 7,068 | 11,468 |
Recurring Fair Value Measurements [Member] | Corporate Securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 20,250 | 35,304 |
Recurring Fair Value Measurements [Member] | Federal Agency Securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 16,413 | 19,346 |
Recurring Fair Value Measurements [Member] | Municipal Securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 1,350 | 1,359 |
Nonrecurring Fair Value Measurements [Member] | Property and Equipment [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total Gains (Losses), Property and equipment | (129) | (1,487) |
Significant Other Observable Inputs (Level 2) [Member] | Recurring Fair Value Measurements [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 54,125 | 78,444 |
Significant Other Observable Inputs (Level 2) [Member] | Recurring Fair Value Measurements [Member] | Certificates of Deposit [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 9,044 | 10,967 |
Significant Other Observable Inputs (Level 2) [Member] | Recurring Fair Value Measurements [Member] | Commercial Paper [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 7,068 | 11,468 |
Significant Other Observable Inputs (Level 2) [Member] | Recurring Fair Value Measurements [Member] | Corporate Securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 20,250 | 35,304 |
Significant Other Observable Inputs (Level 2) [Member] | Recurring Fair Value Measurements [Member] | Federal Agency Securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 16,413 | 19,346 |
Significant Other Observable Inputs (Level 2) [Member] | Recurring Fair Value Measurements [Member] | Municipal Securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | $ 1,350 | $ 1,359 |
Inventories, Net - Schedule of
Inventories, Net - Schedule of Components of Inventories Net of Allowances (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Inventory Disclosure [Abstract] | ||
Finished goods | $ 1,437 | $ 2,489 |
Work-in-process | 3,661 | 3,542 |
Raw materials and supplies | 2,148 | 2,577 |
Total inventories | 7,246 | 8,608 |
Plus: non-current raw materials and finished goods | 2,667 | 4,330 |
Inventories, net | $ 9,913 | $ 12,938 |
Inventories, Net - Additional I
Inventories, Net - Additional Information (Details) - USD ($) | 3 Months Ended | ||
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | |
Inventory [Line Items] | |||
Inventory Valuation Reserves | $ 5,561,000 | $ 2,938,000 | |
Inventory obsolescence reserve | 2,831,000 | $ 528,000 | |
Increase (decrease) in inventory valuation reserves | 1,521,000 | (5,000,000) | |
Inventory Valuation and Obsolescence [Member] | |||
Inventory [Line Items] | |||
Inventory obsolescence reserve | $ (207,000) | $ 500,000 |
Property and Equipment, Net - A
Property and Equipment, Net - Additional Information (Details) - USD ($) | 1 Months Ended | 3 Months Ended | |
Feb. 28, 2019 | Mar. 31, 2019 | Mar. 31, 2018 | |
Property Plant And Equipment [Line Items] | |||
Losses on disposal of property and equipment | $ 900,000 | $ 851,000 | $ 108,000 |
Operating failures of equipment cost | 171,000 | ||
Depreciation | 42,000 | ||
Fair value of property and equipment | 0 | ||
Research and Development [Member] | |||
Property Plant And Equipment [Line Items] | |||
Impairment charges | $ 129,000 | $ 0 |
Leases - Additional Information
Leases - Additional Information (Details) | 3 Months Ended | |
Mar. 31, 2019USD ($)RenewalTermOption | Mar. 31, 2018USD ($) | |
Lessee Lease Description [Line Items] | ||
Operating lease expense | $ 721,000 | |
Cash paid for measurement of operating lease liabilities | $ 755,000 | |
Lease expense | $ 1,007,000 | |
Weighted average remaining lease term of operating leases | 8 years 4 months 24 days | |
Weighted average discount rate of operating leases | 9.25% | |
Office and Lab Space [Member] | ||
Lessee Lease Description [Line Items] | ||
Operating lease, expiration date range start | Jun. 30, 2021 | |
Operating lease, expiration date range end | Feb. 29, 2032 | |
Third Operating Lease [Member] | ||
Lessee Lease Description [Line Items] | ||
Operating lease, expiration date | Jan. 31, 2022 | |
Primary Manufacturing Facility [Member] | ||
Lessee Lease Description [Line Items] | ||
Operating lease, number of renewal term option following expiration date | RenewalTermOption | 2 | |
Operating lease, option to extend term | 5 years | |
Operating lease option to extend, description | option to extend our primary manufacturing facility operating lease for two 5-year periods following the February 2032 expiration date | |
Operating lease, existence of option to extend | true | |
Operating lease, irrevocable letter of credit balance required to be maintained | $ 267,000 | |
Operating lease, period after expiration date for letter of credit required to be maintained | 30 days | |
Second Primary Manufacturing Facility [Member] | ||
Lessee Lease Description [Line Items] | ||
Operating lease, number of renewal term option following expiration date | RenewalTermOption | 1 | |
Operating lease, option to extend term | 5 years | |
Operating lease option to extend, description | We have the option the extend a second operating lease for one 5-year period following the June 2021 expiration date. |
Leases - Summary of Maturities
Leases - Summary of Maturities of Operating Lease Liabilities under Topic 842 (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Jan. 01, 2019 |
Years ending December 31, | ||
Remainder of 2019 | $ 2,289 | |
2020 | 3,128 | |
2021 | 2,340 | |
2022 | 1,283 | |
2023 | 1,295 | |
Thereafter | 11,851 | |
Total operating lease payments | 22,186 | |
Less: imputed interest | 8,184 | |
Total current and non-current operating lease liabilities | $ 14,002 | $ 14,400 |
Leases - Summary of Future Mini
Leases - Summary of Future Minimum Commitments for Operating Leases under Topic 840 (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Years ending December 31, | |
2019 | $ 3,044 |
2020 | 3,128 |
2021 | 2,340 |
2022 | 1,283 |
2023 | 1,295 |
Thereafter | 11,851 |
Total operating lease payments | $ 22,941 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) | Apr. 10, 2019USD ($) | Feb. 22, 2019USD ($) | Feb. 19, 2019USD ($) | Aug. 08, 2018USD ($) | Jun. 01, 2018USD ($) | Oct. 20, 2017USD ($) | Jul. 12, 2017USD ($) | Apr. 06, 2017USD ($) | Mar. 01, 2016 | Nov. 01, 2015USD ($) | Jun. 23, 2015USD ($) | Feb. 28, 2019USD ($) | Jun. 28, 2018USD ($) | Oct. 30, 2015 | Apr. 30, 2015 | Mar. 31, 2019USD ($)LawsuitDevice | Mar. 31, 2018USD ($) | Sep. 30, 2017USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Apr. 30, 2018USD ($) | Apr. 13, 2018Lawsuit | Mar. 31, 2017USD ($) |
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||
Estimated Contingent Liability | $ 240,300,000 | |||||||||||||||||||||||
Income Tax benefit | 1,246,000 | $ 171,000 | ||||||||||||||||||||||
Litigation settlement, expense | 73,863,000 | 740,000 | ||||||||||||||||||||||
Accrued legal expense | 56,843,000 | $ 32,625,000 | ||||||||||||||||||||||
Purchase Obligation | 6,000,000 | |||||||||||||||||||||||
Losses on disposal of property and equipment | $ 900,000 | 851,000 | 108,000 | |||||||||||||||||||||
Renaissance [Member] | ||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||
Purchase Obligation Per Calendar Year | $ 3,000,000 | |||||||||||||||||||||||
Purchase Obligation | $ 12,000,000 | |||||||||||||||||||||||
Contractual Obligation | $ 0 | |||||||||||||||||||||||
Extended period of agreement | 2020 | |||||||||||||||||||||||
Renaissance [Member] | Scenario Forecast [Member] | ||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||
Purchase Obligation Per Calendar Year | $ 2,000,000 | $ 2,000,000 | ||||||||||||||||||||||
Purchase Obligation | $ 7,000,000 | |||||||||||||||||||||||
Aptargroup, Inc [Member] | ||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||
Join agreement period | 7 years | |||||||||||||||||||||||
Purchase Obligation | $ 9,000,000 | $ 20,790,000 | ||||||||||||||||||||||
Minimum devices to be purchased to evade annual flat fee | Device | 1,000,000 | |||||||||||||||||||||||
Contractual Obligation | $ 6,000,000 | |||||||||||||||||||||||
Settled Litigation [Member] | ||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||
Estimated Contingent Liability | 48,000,000 | |||||||||||||||||||||||
Federal Securities Litigation [Member] | ||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||
Estimated Contingent Liability | 19,800,000 | |||||||||||||||||||||||
Maximum [Member] | ||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||
Estimated Contingent Liability | 130,000,000 | |||||||||||||||||||||||
Maximum [Member] | Aptargroup, Inc [Member] | ||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||
Tiered royalties as percentage of net revenue | 1.00% | |||||||||||||||||||||||
Purchase Obligation Per Calendar Year | $ 500,000 | |||||||||||||||||||||||
Maximum [Member] | Federal Securities Litigation [Member] | ||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||
Estimated Contingent Liability | 24,600,000 | |||||||||||||||||||||||
Minimum [Member] | ||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||
Estimated Contingent Liability | 48,000,000 | |||||||||||||||||||||||
Minimum [Member] | Federal Securities Litigation [Member] | ||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||
Estimated Contingent Liability | 15,600,000 | |||||||||||||||||||||||
U S Department Of Justice [Member] | ||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||
Number of lawsuits declined to intervene in part | Lawsuit | 5 | |||||||||||||||||||||||
Estimated Contingent Liability | 150,000,000 | |||||||||||||||||||||||
Litigation settlement payment period | 5 years | 5 years | ||||||||||||||||||||||
Accrued interest expense | 1,063,000 | |||||||||||||||||||||||
Income Tax benefit | $ 0 | |||||||||||||||||||||||
U S Department Of Justice [Member] | Maximum [Member] | ||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||
Estimated Contingent Liability | $ 150,000,000 | $ 150,000,000 | ||||||||||||||||||||||
Loss Contingency, Estimate of Possible Loss | 75,000,000 | |||||||||||||||||||||||
U S Department Of Justice [Member] | Minimum [Member] | ||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||
Loss Contingency, Estimate of Possible Loss | $ 0 | |||||||||||||||||||||||
Anti-Kickback Statute Litigation [Member] | Settled Litigation [Member] | ||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||
Payments In Question | $ 83,000 | |||||||||||||||||||||||
Anti-Kickback Statute Litigation [Member] | Minimum [Member] | Settled Litigation [Member] | ||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||
Payments In Question | $ 103,000 | |||||||||||||||||||||||
Kickbacks [Member] | Settled Litigation [Member] | ||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||
Payments In Question | $ 188,000 | |||||||||||||||||||||||
Criminal and Civil Defense Of Dr. Kapoor [Member] | Indemnity Agreements [Member] | ||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||
Litigation settlement, expense | 18,100,000 | |||||||||||||||||||||||
Accrued legal expense | 38,100,000 | |||||||||||||||||||||||
Cash payments on legal expenses | $ 1,800,000 | |||||||||||||||||||||||
Multi-District Prescription Opioid Litigation [Member] | ||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||
Description of allegation | We have also been named, along with various other opioid manufacturers and distributors, in putative class action complaints that seek to assert claims allegedly related to the national opioid epidemic on behalf of (1) purchasers of health insurance between 1996 and the present, and (2) children born addicted to opioids. Most of these cases have been consolidated into MDL No. 2804. Finally, Insys has been named in at least one lawsuit in which a personal injury plaintiff sued Insys and other opioid manufacturers for harm allegedly caused by a tortfeasor who was addicted to opioids. | |||||||||||||||||||||||
Multi-District Prescription Opioid Litigation [Member] | Maximum [Member] | ||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||
Number of lawsuit personal injury plaintiff | Lawsuit | 1 | |||||||||||||||||||||||
Gotham Asset Management, LLC [Member] | Threatened Litigation [Member] | Subsequent Event [Member] | ||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||
Loss Contingency, Damages Sought, Value | $ 20,000,000 | |||||||||||||||||||||||
Kottayil vs. Insys Pharma, Inc. [Member] | Threatened Litigation [Member] | ||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||
Loss Contingency, Damages Sought, Value | $ 3,630,000 | $ 3,630,000 | ||||||||||||||||||||||
Loss Contingency, Damages Sought, Description | On or around November 1, 2015, we received a notice from Dr. Kottayil’s attorneys demanding indemnification for legal and other defense costs alleged to have been incurred in connection with Dr. Kottayil’s defense of the Insys Pharma counterclaims in the amount of $3,630,000. We responded to these demands by, among other things, requesting supporting documents and information from the plaintiffs’ counsel, which we have not received. On June 1, 2018, Dr. Kottayil filed a complaint in Superior Court in the State of Arizona in and for the County of Maricopa against Insys Pharma, Inc., our wholly owned subsidiary. The complaint seeks indemnification in the amount of $3,630,000, plus interest. | |||||||||||||||||||||||
Legal rate of interest percentage over Federal Reserve discount rate | 5.00% | |||||||||||||||||||||||
Kottayil vs. Insys Pharma, Inc. [Member] | Maximum [Member] | Threatened Litigation [Member] | ||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||
Loss Contingency, Estimate of Possible Loss | $ 3,630,000 | |||||||||||||||||||||||
Kottayil vs. Insys Pharma, Inc. [Member] | Minimum [Member] | Threatened Litigation [Member] | ||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||
Loss Contingency, Estimate of Possible Loss | $ 0 | |||||||||||||||||||||||
Anthem Blue Cross of California Vs Insys Therapeutics Inc [Member] | Minimum [Member] | ||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||
Loss Contingency, Damages Sought, Value | $ 19,000,000 | |||||||||||||||||||||||
United Healthcare Services, Inc. [Member] | ||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||
Estimated Contingent Liability | $ 3,600,000 | $ 3,600,000 | ||||||||||||||||||||||
Claims paid to plaintiff | $ 50,000,000 | |||||||||||||||||||||||
United Healthcare Services, Inc. [Member] | Settled Litigation [Member] | ||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||
Estimated Contingent Liability | 16,000,000 | |||||||||||||||||||||||
United Healthcare Services, Inc. [Member] | Maximum [Member] | ||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||
Estimated Contingent Liability | 10,000,000 | |||||||||||||||||||||||
United Healthcare Services, Inc. [Member] | Minimum [Member] | ||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||
Estimated Contingent Liability | $ 2,000,000 | |||||||||||||||||||||||
Horizon Blue Cross Blue Shield of New Jersey [Member] | Minimum [Member] | ||||||||||||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||||||||||||
Loss Contingency, Damages Sought, Value | $ 4,000,000 | |||||||||||||||||||||||
Loss Contingency Excess Damages Sought Value | $ 2,000,000 |
Commitments and Contingencies_2
Commitments and Contingencies - Summary of Aggregate Minimum Purchase Commitments and Exclusive Supply Rights (Details) $ in Thousands | Mar. 31, 2019USD ($) |
Years ending December 31, | |
Remainder of 2019 | $ 2,000 |
2020 | 2,000 |
2021 | 2,000 |
Total | $ 6,000 |
Stock-based Compensation - Amou
Stock-based Compensation - Amounts Recognized in Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss with Respect to Stock-Based Compensation Plans (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total cost of stock-based compensation | $ 3,109 | $ 3,170 |
Research and Development Expense [Member] | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total cost of stock-based compensation | 715 | 847 |
General and Administrative Expense [Member] | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total cost of stock-based compensation | $ 2,394 | $ 2,323 |
Stock-based Compensation - Addi
Stock-based Compensation - Additional Information (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Share-based Compensation Arrangement by Share-based Payment Award Accelerated Compensation Cost | $ 786,000 | $ 0 |
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Stock Options | 15,780,000 | |
Proceeds from Stock Options Exercised | $ 18,000 | $ 524,000 |
Stock Options [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 2 years 9 months 18 days | |
Restricted Stock Units [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 2 years | |
Employee service share-based compensation, nonvested awards, compensation not yet recognized | $ 3,671,000 |
Stock-based Compensation - Summ
Stock-based Compensation - Summary of Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | 12 Months Ended |
Mar. 31, 2019 | Dec. 31, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ||
Number of Shares, Vested and exercisable, Beginning balance | 3,798,636 | |
Number of Shares, Outstanding, Beginning balance | 6,127,202 | |
Number of Shares, Granted | 2,543,119 | |
Number of Shares, Cancelled | (525,882) | |
Number of Shares, Exercised | (4,537) | |
Number of Shares, Outstanding, Ending balance | 8,139,902 | 6,127,202 |
Number of Shares, Vested and exercisable, Ending balance | 4,095,983 | 3,798,636 |
Weighted Average Exercise Price, Vested and exercisable, Beginning balance | $ 12.33 | |
Weighted Average Exercise Price, Outstanding, Beginning balance | 11.55 | |
Weighted Average Exercise Price, Granted | 3.94 | |
Weighted Average Exercise Price, Cancelled | 10.58 | |
Weighted Average Exercise Price, Exercised | 4.05 | |
Weighted Average Exercise Price, Outstanding, Ending balance | 9.24 | $ 11.55 |
Weighted Average Exercise Price, Vested and exercisable, Ending balance | $ 12.02 | $ 12.33 |
Weighted Average Remaining Contractual Term, Vested and exercisable | 5 years 10 months 24 days | 6 years 1 month 6 days |
Weighted Average Remaining Contractual Term, Outstanding as of March 31, 2019 | 7 years 7 months 6 days | |
Aggregate Intrinsic Value, Vested and exercisable | $ 2.2 | $ 1.2 |
Aggregate Intrinsic Value, Outstanding as of March 31, 2019 | $ 4 |
Stock-based Compensation - Su_2
Stock-based Compensation - Summary of Restricted Stock Unit Activity (Details) - Restricted Stock Units [Member] | 3 Months Ended |
Mar. 31, 2019$ / sharesshares | |
Number of Shares [Abstract] | |
Number of Units, Outstanding, Beginning balance | shares | 535,828 |
Number of Units, Granted | shares | 486,494 |
Number of units, Exercised | shares | (127,446) |
Number of Units, Cancelled | shares | (90,749) |
Number of Units, Outstanding, Ending balance | shares | 804,127 |
Weighted Average Grant Date Fair Value Per Unit [Abstract] | |
Weighted Average Grant-Date Fair Value Per Unit, Outstanding, Beginning balance | $ / shares | $ 9.01 |
Weighted Average Grant-Date Fair Value Per Unit, Granted | $ / shares | 4.06 |
Weighted Average Grant-Date Fair Value Per Unit, Exercised | $ / shares | 9.61 |
Weighted Average Grant-Date Fair Value Per Unit, Cancelled | $ / shares | 0.69 |
Weighted Average Grant-Date Fair Value Per Unit, Outstanding, Ending balance | $ / shares | $ 2.43 |
Net Loss per Share - Additional
Net Loss per Share - Additional Information (Details) - shares | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Earnings Per Share [Abstract] | ||
Anti-dilutive securities excluded from computation of earnings per share, Shares | 8,944,029 | 7,615,687 |
Net Loss per Share - Computatio
Net Loss per Share - Computation of Basic and Diluted Net Loss Per Common Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Historical net loss per share - Basic | ||
Net loss | $ (123,844) | $ (20,370) |
Weighted average number of common shares outstanding | 74,426,030 | 73,745,202 |
Basic net loss per common share | $ (1.66) | $ (0.28) |
Historical net loss per share - Diluted | ||
Net loss | $ (123,844) | $ (20,370) |
Weighted average number of common shares outstanding | 74,426,030 | 73,745,202 |
Weighted average number of common shares outstanding | 74,426,030 | 73,745,202 |
Diluted net loss per common share | $ (1.66) | $ (0.28) |
Product Lines, Concentration _3
Product Lines, Concentration of Credit Risk and Significant Customers - Additional Information (Details) | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2019ProductLineWholesalerRetailer | Mar. 31, 2018WholesalerRetailer | Dec. 31, 2018WholesalerRetailer | |
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | |||
Number of Product Lines | ProductLine | 2 | ||
Customer Concentration Risk [Member] | Sales Revenue Net [Member] | Pharmaceutical Wholesaler Customer One [Member] | |||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | |||
Concentration Risk, Percentage | 24.00% | 31.00% | |
Customer Concentration Risk [Member] | Sales Revenue Net [Member] | Pharmaceutical Wholesaler Customer Two [Member] | |||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | |||
Concentration Risk, Percentage | 21.00% | 18.00% | |
Customer Concentration Risk [Member] | Sales Revenue Net [Member] | Pharmaceutical Wholesaler Customer Three [Member] | |||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | |||
Concentration Risk, Percentage | 13.00% | ||
Customer Concentration Risk [Member] | Sales Revenue Net [Member] | Pharmaceutical Wholesalers [Member] | |||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | |||
Concentration Risk, Number of Customers | Wholesaler | 3 | 2 | |
Customer Concentration Risk [Member] | Sales Revenue Net [Member] | Specialty Pharmaceutical Retailers Customer One [Member] | |||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | |||
Concentration Risk, Percentage | 20.00% | 22.00% | |
Customer Concentration Risk [Member] | Sales Revenue Net [Member] | Specialty Pharmaceutical Retailers Customer Two [Member] | |||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | |||
Concentration Risk, Percentage | 19.00% | 17.00% | |
Customer Concentration Risk [Member] | Sales Revenue Net [Member] | Specialty Pharmaceutical Retailers [Member] | |||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | |||
Concentration Risk, Number of Customers | Retailer | 2 | 2 | |
Customer Concentration Risk [Member] | Accounts Receivable [Member] | Pharmaceutical Wholesaler Customer One [Member] | |||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | |||
Concentration Risk, Percentage | 25.00% | 58.00% | |
Customer Concentration Risk [Member] | Accounts Receivable [Member] | Pharmaceutical Wholesaler Customer Two [Member] | |||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | |||
Concentration Risk, Percentage | 24.00% | ||
Customer Concentration Risk [Member] | Accounts Receivable [Member] | Pharmaceutical Wholesaler Customer Three [Member] | |||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | |||
Concentration Risk, Percentage | 16.00% | ||
Customer Concentration Risk [Member] | Accounts Receivable [Member] | Pharmaceutical Wholesalers [Member] | |||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | |||
Concentration Risk, Number of Customers | Wholesaler | 3 | 1 | |
Customer Concentration Risk [Member] | Accounts Receivable [Member] | Specialty Pharmaceutical Retailers Customer One [Member] | |||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | |||
Concentration Risk, Percentage | 20.00% | 19.00% | |
Customer Concentration Risk [Member] | Accounts Receivable [Member] | Specialty Pharmaceutical Retailers Customer Two [Member] | |||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | |||
Concentration Risk, Percentage | 13.00% | 11.00% | |
Customer Concentration Risk [Member] | Accounts Receivable [Member] | Specialty Pharmaceutical Retailers [Member] | |||
Product Lines Concentration Of Credit Risk And Significant Customers [Line Items] | |||
Concentration Risk, Number of Customers | Retailer | 2 | 2 |
Product Lines, Concentration _4
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 | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Segment Reporting Information [Line Items] | ||
Revenues | $ 7,630 | $ 23,911 |
SUBSYS [Member] | ||
Segment Reporting Information [Line Items] | ||
Revenues | 7,233 | 23,274 |
SYNDROS [Member] | ||
Segment Reporting Information [Line Items] | ||
Revenues | $ 397 | $ 637 |
Product Lines, Concentration _5
Product Lines, Concentration of Credit Risk and Significant Customers - Percentage of Revenue by Route to Market (Details) - Sales Revenue, Product Line [Member] - Customer Concentration Risk [Member] | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Segment Reporting Information [Line Items] | ||
Concentration Risk Percentage | 100.00% | 100.00% |
Pharmaceutical Wholesalers [Member] | ||
Segment Reporting Information [Line Items] | ||
Concentration Risk Percentage | 61.00% | 61.00% |
Specialty Pharmaceutical Retailers [Member] | ||
Segment Reporting Information [Line Items] | ||
Concentration Risk Percentage | 39.00% | 39.00% |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) - Subsequent Event [Member] - USD ($) | May 07, 2019 | Apr. 17, 2019 |
National Institute on Drug Abuse [Member] | ||
Subsequent Event [Line Items] | ||
Total grant amount | $ 10,300,000 | |
Grant term | 5 years | |
Chief Executive Officer [Member] | ||
Subsequent Event [Line Items] | ||
Cash retention bonuses | $ 1,100,000 | |
Chief Financial Officer [Member] | ||
Subsequent Event [Line Items] | ||
Cash retention bonuses | 400,000 | |
Chief Legal Officer and General Counsel [Member] | ||
Subsequent Event [Line Items] | ||
Cash retention bonuses | $ 613,000 |