Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2018 | Oct. 30, 2018 | |
Document and Entity Information | ||
Entity Registrant Name | VIVUS INC | |
Entity Central Index Key | 881,524 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2018 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 10,629,923 | |
Document Fiscal Year Focus | 2,018 | |
Document Fiscal Period Focus | Q3 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 58,022 | $ 66,392 |
Available-for-sale securities | 57,096 | 159,943 |
Accounts receivable, net | 23,625 | 12,187 |
Inventories | 21,603 | 17,712 |
Prepaid expenses and other current assets | 7,744 | 7,178 |
Total current assets | 168,090 | 263,412 |
Property and equipment, net | 381 | 542 |
Intangible and other non-current assets | 137,918 | 1,014 |
Total assets | 306,389 | 264,968 |
Current liabilities: | ||
Accounts payable | 4,483 | 10,072 |
Accrued and other liabilities | 31,924 | 21,475 |
Deferred revenue | 2,159 | 2,075 |
Current portion of long-term debt | 5,147 | |
Total current liabilities | 38,566 | 38,769 |
Long-term debt, net of current portion | 300,182 | 230,536 |
Deferred revenue, net of current portion | 3,686 | 4,674 |
Non-current accrued and other liabilities | 258 | 327 |
Total liabilities | 342,692 | 274,306 |
Commitments and contingencies | ||
Stockholders' deficit | ||
Preferred stock; $1.00 par value; 5,000 shares authorized; no shares issued and outstanding at September 30, 2018 and December 31, 2017 | 0 | 0 |
Common stock; $.001 par value; 200,000 shares authorized; 10,628 and 10,603 shares issued and outstanding at September 30, 2018 and December 31, 2017, respectively | 11 | 11 |
Additional paid-in capital | 840,100 | 834,824 |
Accumulated other comprehensive loss | (399) | (608) |
Accumulated deficit | (876,015) | (843,565) |
Total stockholders' deficit | (36,303) | (9,338) |
Total liabilities and stockholders' deficit | $ 306,389 | $ 264,968 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares shares in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
CONDENSED CONSOLIDATED BALANCE SHEETS | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000 | 5,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 200,000 | 200,000 |
Common stock, shares issued | 10,628 | 10,603 |
Common stock, shares outstanding | 10,628 | 10,603 |
Consolidated Statements Of Oper
Consolidated Statements Of Operations - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Revenue: | ||||
Revenues | $ 18,088 | $ 15,193 | $ 44,948 | $ 53,432 |
Operating expenses: | ||||
Cost of goods sold (excluding amortization) | 3,484 | 3,423 | 9,400 | 12,798 |
Amortization of Intangible Assets | 3,638 | 91 | 5,002 | 453 |
Selling, general and administrative | 8,456 | 8,388 | 30,235 | 31,449 |
Research and development | 2,102 | 865 | 5,547 | 4,059 |
Total operating expenses | 17,680 | 12,767 | 50,184 | 48,759 |
Income (loss) from operations | 408 | 2,426 | (5,236) | 4,673 |
Interest expense and other expense, net | 9,595 | 8,412 | 27,162 | 25,112 |
Loss before income taxes | (9,187) | (5,986) | (32,398) | (20,439) |
Provision for (benefit from) income taxes | 36 | 8 | 52 | (3) |
Net loss | $ (9,223) | $ (5,994) | $ (32,450) | $ (20,436) |
Basic and diluted net loss per share: | ||||
Basic and diluted net loss per share (in dollars per share) | $ (0.87) | $ (0.57) | $ (3.06) | $ (1.93) |
Shares used in per share computation: | ||||
Basic and diluted (in shares) | 10,628 | 10,583 | 10,617 | 10,567 |
Net Product Revenue | ||||
Revenue: | ||||
Revenues | $ 16,484 | $ 9,911 | $ 39,366 | $ 36,049 |
License and Milestone Revenue | ||||
Revenue: | ||||
Revenues | 2,500 | 7,500 | ||
Supply Revenue | ||||
Revenue: | ||||
Revenues | 478 | 2,133 | 3,203 | 8,064 |
Royalty Revenue | ||||
Revenue: | ||||
Revenues | $ 1,126 | $ 649 | $ 2,379 | $ 1,819 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | ||||
Net loss | $ (9,223) | $ (5,994) | $ (32,450) | $ (20,436) |
Other comprehensive loss: | ||||
Unrealized gain on securities, net of taxes | 109 | 125 | 208 | 359 |
Translation adjustment | 1 | |||
Comprehensive loss | $ (9,114) | $ (5,869) | $ (32,241) | $ (20,077) |
Consolidated Statements Of Cash
Consolidated Statements Of Cash Flow - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
Cash flows from operating activities: | ||
Net loss | $ (32,450) | $ (20,436) |
Adjustments to reconcile net loss to net cash used for operating activities: | ||
Depreciation and amortization | 5,197 | 656 |
Amortization of debt issuance costs and discounts | 15,390 | 15,163 |
Amortization of discount or premium on available-for-sale securities | 638 | 605 |
Share-based compensation expense | 2,650 | 2,221 |
Changes in assets and liabilities: | ||
Accounts receivable | (11,438) | (2,328) |
Inventories | (3,276) | 2,744 |
Prepaid expenses and other assets | (577) | 4,490 |
Accounts payable | (5,589) | (277) |
Accrued and other liabilities | 3,698 | 4,211 |
Deferred revenue | (904) | (18,534) |
Net cash used for operating activities | (26,661) | (11,485) |
Cash flows from investing activities: | ||
Property and equipment purchases | (34) | (21) |
Acquisition of PANCREAZE license | (135,000) | |
Purchases of available-for-sale securities | (7,604) | (20,915) |
Proceeds from maturity of available-for-sale securities | 48,356 | 29,120 |
Proceeds from sales of available-for-sale securities | 61,666 | 13,413 |
Net cash (used for) provided by investing activities | (32,616) | 21,597 |
Cash flows from financing activities: | ||
Net proceeds from debt issuance | 107,991 | |
Repayments of notes payable | (57,187) | (21,770) |
Net proceeds from exercise of common stock options | 79 | |
Sale of common stock through employee stock purchase plan | 24 | 26 |
Net cash provided by (used for) financing activities | 50,907 | (21,744) |
Net decrease in cash and cash equivalents | (8,370) | (11,632) |
Cash and cash equivalents: | ||
Beginning of period | 66,392 | 84,783 |
End of period | $ 58,022 | $ 73,151 |
Basis and Significant Accountin
Basis and Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2018 | |
BASIS OF PRESENTATION | |
Business and Significant Accounting Policies | 1. BUSINESS AND SIGNIFICANT ACCOUNTING POLICIES VIVUS is a specialty pharmaceutical company with three approved therapies (Qsymia®, STENDRA® and PANCREAZE®) and one product candidate in active clinical development (VI-0106). Qsymia (phentermine and topiramate extended release) is approved by the U.S. Food and Drug Administration, or FDA, for chronic weight management. STENDRA (avanafil) is approved by FDA for erectile dysfunction, or ED, and by the European Commission, or EC, under the trade name SPEDRA, for the treatment of ED. In June 2018, the Company acquired the U.S. and Canadian commercial rights for PANCREAZE (pancrelipase), which is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions. The Company commercializes Qsymia and PANCREAZE in the U.S. through a small sales force supported by an internal commercial team. The Company licenses the commercial rights to STENDRA/SPEDRA in the U.S., EU and other countries and to PANCREAZE in Canada. VI-0106 (tacrolimus) is in active clinical development and is being studied in patients with pulmonary arterial hypertension, or PAH. When reference is made to the “Company” or “VIVUS” in these footnotes, it refers to the Delaware corporation, or VIVUS, Inc., and, unless the context otherwise requires, its California predecessor, as well as all of its consolidated subsidiaries. Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or U.S. GAAP, for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been included. Operating results for the three and nine months ended September 30, 2018 are not necessarily indicative of the results that may be expected for the year ending December 31, 2018. Management has evaluated all events and transactions that occurred after September 30, 2018 through the date these unaudited condensed consolidated financial statements were filed. There were no events or transactions during this period that require recognition or disclosure in these unaudited condensed consolidated financial statements. The December 31, 2017 condensed consolidated balance sheet data was derived from audited financial statements, but does not include all disclosures required by U.S. GAAP. The unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017 as filed on March 14, 2018 with the Securities and Exchange Commission, or SEC, and as amended by the Form 10-K/A filed on April 26, 2018 with the SEC. Certain amounts have been reclassified to conform to current year presentation. The unaudited condensed consolidated financial statements include the accounts of VIVUS, Inc. and its wholly-owned subsidiaries. All significant intercompany accounts and transactions have been eliminated. Reverse Stock Split On September 10, 2018, the Company effected a one-for-10 reverse stock split of its common stock. As a result of the reverse stock split, every 10 shares of the Company’s pre-reverse split common stock issued and outstanding was combined and converted into one issued and outstanding share of post-reverse split common stock without any change in the par value of the shares. Accordingly, an amount equal to the par value of the decreased shares resulting from the reverse stock split was reclassified from “Common stock” to “Additional paid-in capital.” No fractional shares were issued as a result of the reverse stock split; any fractional shares that would have resulted were rounded up to the nearest whole share. Proportionate voting rights and other rights of stockholders were not affected by the reverse stock split, other than as a result of the rounding up of potential fractional shares. All stock options, warrants and restricted stock units outstanding and common stock reserved for issuance under the Company’s equity incentive plans immediately prior to the reverse stock split were adjusted by dividing the number of affected shares of common stock by 10 and, where applicable, multiplying the exercise price by 10. All share and per share amounts related to common stock, stock options, warrants and restricted stock units have been restated for all periods to give retroactive effect to the reverse stock split. Use of Estimates The preparation of these unaudited condensed consolidated financial statements requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues, expenses and related disclosures. On an ongoing basis, the Company evaluates its estimates, including critical accounting policies or estimates related to available-for-sale securities, debt instruments, research and development expenses, income taxes, inventories, revenues, contingencies and litigation and share-based compensation. The Company bases its estimates on historical experience, information received from third parties and on various market specific and other relevant assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ significantly from those estimates under different assumptions or conditions. Significant Accounting Policies There have been no changes to the Company’s significant accounting policies since the Company’s Annual Report on Form 10-K for the year ended December 31, 2017 with the exception of its revenue recognition policy as discussed in Note 2. Recent Accounting Pronouncement Adopted In May 2014, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers . This standard is a comprehensive new revenue recognition model that requires revenue to be recognized in a manner to depict the transfer of goods or services to a customer at an amount that reflects the consideration expected to be received in exchange for those goods or services. This new standard supersedes most previously-existing revenue recognition guidance. The Company adopted this standard in January 2018 using the modified retrospective basis. See Note 2. In August 2016, the FASB issued Accounting Standards Update 2016-15, Statement of Cash Flows (Topic 230) Classification of Certain Cash Receipts and Cash Payments . The standard clarifies how certain cash receipts and cash payments will be presented and classified in the statement of cash flows. The Company adopted this standard in January 2018, and it had no impact on its consolidated financial statements. Recent Accounting Pronouncements Not Yet Adopted In February 2016, the FASB issued Accounting Standards Update 2016-02, Leases (Topic 842), which modifies the accounting by lessees for all leases with a term greater than 12 months. This standard will require lessees to recognize on the balance sheet the assets and liabilities for the rights and obligations created by those leases. For public companies, this standard is effective for annual and interim periods beginning on or after December 15, 2018. Early adoption is permitted, but the Company intends to adopt this guidance effective January 1, 2019 using a modified retrospective transition method, not adjusting comparative periods. The Company’s only significant lease is its operating lease for its corporate headquarters, although it has several smaller leases. The Company is completing its analysis, but expects the adoption of this guidance to have a significant impact on its balance sheets as it will recognize right of use assets and corresponding lease liabilities. The Company expects the impact on accumulated deficit to be minimal. The Company expects the overall ongoing recognition of expense to be similar to current guidance, though the classification of such expense could be significantly different. |
Revenues
Revenues | 9 Months Ended |
Sep. 30, 2018 | |
REVENUE INFORMATION | |
Revenue from Contract with Customer | 2. REVENUES On January 1, 2018, the Company adopted Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers , or Topic 606. Topic 606 supersedes the revenue recognition requirements in Topic 605 Revenue Recognition , or Topic 605, and requires entities to recognize revenue when control of the promised goods or services is transferred to customers at an amount that reflects the consideration to which the entity expects to be entitled to in exchange for those goods or services. The Company adopted Topic 606 as of January 1, 2018 using the modified retrospective transition method applied to those contracts which were not completed as of January 1, 2018. Results for reporting periods beginning on or after January 1, 2018 are presented under Topic 606, while prior period amounts are not adjusted and continue to be reported in accordance with our historic accounting under Topic 605. Due in large part to the change in accounting estimate made by the Company in the first quarter of 2017, revenue amounts as reported for the three and nine months ended September 30, 2017 under Topic 605 are approximately the same as they would have been under Topic 606, and the Company did not have or record a cumulative impact of adopting Topic 606 as of January 1, 2018. Revenue Recognition For all revenue transactions, the Company evaluates its contracts with its customers to determine revenue recognition using the following five-step model: 1) 2) 3) 4) 5) Product Revenue Product revenue is recognized at the time of shipment at which time the Company has satisfied its performance obligation. Product revenue is recognized net of consideration paid to the Company’s customers, wholesalers and certified pharmacies. Such consideration is for services rendered by the wholesalers and pharmacies in accordance with the wholesalers and certified pharmacy services network agreements, and includes a fixed rate per prescription shipped and monthly program management and data fees. These services are not deemed sufficiently separable from the customers’ purchase of the product; therefore, they are recorded as a reduction of revenue at the time of revenue recognition. Other product revenue allowances include a reserve for estimated product returns, certain prompt pay discounts and allowances offered to the Company’s customers, program rebates and chargebacks. These product revenue allowances are recognized as a reduction of revenue at the date at which the related revenue is recognized. The Company also offers discount programs to patients. Calculating certain of these items involves estimates and judgments based on sales or invoice data, contractual terms, utilization rates, new information regarding changes in these programs’ regulations and guidelines that would impact the amount of the actual rebates or chargebacks. The Company reviews the adequacy of product revenue allowances on a quarterly basis. Amounts accrued for product revenue allowances are adjusted when trends or significant events indicate that adjustment is appropriate and to reflect actual experience. See Note 9 for product reserve balances. Change in Accounting Estimate in 2017 The Company ships units of Qsymia through a distribution network that includes certified retail pharmacies. The Company began shipping Qsymia in September 2012 and grants rights to its customers to return unsold product from six months prior to and up to 12 months subsequent to product expiration. This has resulted in a potential return period of from 24 to 36 months depending on the ship date of the product. As the Company had no previous experience in selling Qsymia and given its lengthy return period, the Company was not initially able to reliably estimate expected returns of Qsymia at the time of shipment, which was required by the accounting literature at the time, and therefore recognized revenue when units were dispensed to patients through prescriptions, at which point the product was not subject to return, or when the expiration period had ended. Beginning in the first quarter of 2017, with 48 months of returns experience, the Company believed that it had sufficient data and experience from selling Qsymia to reliably estimate expected returns. Therefore, beginning in the first quarter of 2017, under the then relevant accounting literature, the Company began recognizing revenue from the sales of Qsymia upon shipment and recording a reserve for expected returns at the time of shipment. In accordance with this change in accounting estimate, in the first quarter of 2017 the Company recognized a one-time adjustment relating to products that had been previously shipped, consisting of $17.9 million of gross revenues, adjusted for an expected returns reserve of $5.7 million and estimated gross-to-net charges of $4.9 million, for a net impact of $7.3 million in revenues. The Company also recorded increased cost of goods sold of $0.6 million and marketing expense of $0.7 million associated with the change in accounting estimate. The increase in net product revenue resulted in a decrease in net loss of $6.0 million or $0.57 per share for the nine months ended September 30, 2017. Supply Revenue The Company produces STENDRA/SPEDRA through a contract manufacturing partner and then sells it to the Company’s commercialization partners. The Company is the primary responsible party in the commercial supply arrangements and bears significant risk in the fulfillment of the obligations, including risks associated with manufacturing, regulatory compliance and quality assurance, as well as inventory, financial and credit loss. As such, the Company recognizes supply revenue on a gross basis as the principal party in the arrangements. The Company recognizes supply revenue at the time of shipment and, in the unusual case where the product does not meet contractually-specified product dating criteria at the time of shipment to the partner, the Company records a reserve for estimated product returns. There are no such reserves as of September 30, 2018. License and Milestone Revenue License and milestone revenues related to arrangements, usually license and/or supply agreements, entered into by the Company are recognized by following the five-step process outlined above. The allocation and timing of recognition of such revenue will be determined by that process and the amounts recognized and the timing of that recognition may not exactly follow the wording of the agreement as the amount allocated following the accounting analysis of the agreement may differ and the timing of recognition of a significant performance obligation may predate the contractual date. Royalty Revenue The Company relies on data provided by its collaboration partner in determining its contractually-based royalty revenue. Such data includes accounting estimates and reports for various discounts and allowances, including product returns. The Company records royalty revenues based on the best data available and makes any adjustments to such revenues as such information becomes available. Revenue by Source and Geography Revenue disaggregated by revenue source and by geographic region was as follows (in thousands): Three Months Ended September 30, 2018 2017 U.S. ROW Total U.S. ROW Total Qsymia—Net product revenue $ 9,737 $ — $ 9,737 $ 9,911 $ — $ 9,911 Qsymia—License revenue — — — — 2,500 2,500 PANCREAZE - Net product revenue 6,747 — 6,747 — — — PANCREAZE - Royalty revenue — 576 576 — — — STENDRA/SPEDRA—Supply revenue — 478 478 1,070 1,063 2,133 STENDRA/SPEDRA—Royalty revenue — 550 550 — 649 649 Total revenue $ 16,484 $ 1,604 (1) $ 18,088 $ 10,981 $ 4,212 (2) $ 15,193 Nine Months Ended September 30, 2018 2017 U.S. ROW Total U.S. ROW Total Qsymia—Net product revenue $ 30,503 $ — $ 30,503 $ 36,049 $ — $ 36,049 Qsymia—License revenue — — — 5,000 2,500 7,500 PANCREAZE - Net product revenue 8,863 — 8,863 — — — PANCREAZE - Royalty revenue — 650 650 — — — STENDRA/SPEDRA—Supply revenue 1,071 2,132 3,203 4,845 3,219 8,064 STENDRA/SPEDRA—Royalty revenue — 1,729 1,729 — 1,819 1,819 Total revenue $ 40,437 $ 4,511 (3) $ 44,948 $ 45,894 $ 7,538 (4) $ 53,432 (1) $1.0 million of which was attributable to Germany and $0.6 million of which was attributable to Canada. (2) $1.7 million of which was attributable to Germany and $2.5 million of which was attributable to South Korea. (3) $3.9 million of which was attributable to Germany and $0.6 million of which was attributable to Canada. (4) $5.0 million of which was attributable to Germany and $2.5 million of which was attributable to South Korea. Revenue and cost of goods sold by source was as follows (in thousands): Three Months Ended September 30, 2018 2017 Qsymia PANCREAZE STENDRA/ SPEDRA Total Qsymia STENDRA/ SPEDRA Total Net product revenue $ 9,737 $ 6,747 $ — $ 16,484 $ 9,911 $ — $ 9,911 License — — — — 2,500 — 2,500 Supply revenue — — 478 478 — 2,133 2,133 Royalty revenue — 576 550 1,126 — 649 649 Total revenue $ 9,737 $ 7,323 $ 1,028 $ 18,088 $ 12,411 $ 2,782 $ 15,193 Cost of goods sold (excluding amortization) $ 953 $ 2,006 $ 525 $ 3,484 $ 1,428 $ 1,995 $ 3,423 Amortization of intangible assets $ 91 $ 3,547 $ — $ 3,638 $ 91 $ — $ 91 Nine Months Ended September 30, 2018 2017 Qsymia PANCREAZE STENDRA/ SPEDRA Total Qsymia STENDRA/ SPEDRA Total Net product revenue $ 30,503 $ 8,863 $ — $ 39,366 $ 36,049 $ — $ 36,049 License — — — — 7,500 — 7,500 Supply revenue — — 3,203 3,203 — 8,064 8,064 Royalty revenue — 650 1,729 2,379 — 1,819 1,819 Total revenue $ 30,503 $ 9,513 $ 4,932 $ 44,948 $ 43,549 $ 9,883 $ 53,432 Cost of goods sold (excluding amortization) $ 3,648 $ 2,574 $ 3,178 $ 9,400 $ 5,311 $ 7,487 $ 12,798 Amortization of intangible assets $ 272 $ 4,730 $ — $ 5,002 $ 453 $ — $ 453 |
Share-Based Compensation
Share-Based Compensation | 9 Months Ended |
Sep. 30, 2018 | |
SHARE-BASED COMPENSATION. | |
Disclosure of Compensation Related Costs, Share-based Payments [Text Block] | 3. SHARE-BASED COMPENSATION Total share-based compensation expense for all of the Company’s share-based awards was as follows (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2018 2017 2018 2017 Cost of goods sold $ 18 $ 13 $ 48 $ 41 Selling, general and administrative 581 2,368 Research and development 77 234 Total share-based compensation expense $ $ $ $ Share-based compensation costs capitalized as part of the cost of inventory were $4,000 and $3,000 for the three months ended September 30, 2018 and 2017, respectively, and $5,000 and $8,000 for the nine months ended September 30, 2018 and 2017, respectively. |
Cash, Cash Equivalents, And Ava
Cash, Cash Equivalents, And Available-For-Sale Securities | 9 Months Ended |
Sep. 30, 2018 | |
CASH, CASH EQUIVALENTS, AND AVAILABLE-FOR-SALE SECURITIES | |
CASH, CASH EQUIVALENTS, AND AVAILABLE-FOR-SALE SECURITIES | 4. CASH, CASH EQUIVALENTS, AND AVAILABLE-FOR-SALE SECURITIES The fair value and the amortized cost of cash, cash equivalents, and available-for-sale securities by major security type are presented in the tables that follow (in thousands). As of September 30, 2018 Gross Gross Amortized Unrealized Unrealized Estimated Cash and cash equivalents and available-for-sale securities Cost Gains Losses Fair Value Cash and money market funds $ 58,022 $ — $ — $ 58,022 U.S. Treasury securities 14,513 — (156) 14,357 Corporate debt securities 42,982 6 (249) 42,739 Total 115,517 6 (405) 115,118 Less amounts classified as cash and cash equivalents (58,022) — — (58,022) Total available-for-sale securities $ 57,495 $ 6 $ (405) $ 57,096 As of December 31, 2017 Gross Gross Amortized Unrealized Unrealized Estimated Cash and cash equivalents and available-for-sale securities Cost Gains Losses Fair Value Cash and money market funds $ 66,392 $ — $ — $ 66,392 U.S. Treasury securities 21,070 1 (139) 20,932 Corporate debt securities 139,481 16 (486) 139,011 Total 226,943 17 (625) 226,335 Less amounts classified as cash and cash equivalents (66,392) — — (66,392) Total available-for-sale securities $ 160,551 $ 17 $ (625) $ 159,943 As of September 30, 2018, the Company’s available-for-sale securities had original contractual maturities up to 57 months. However, the Company may sell these securities prior to their stated maturities in response to changes in the availability of and the yield on alternative investments as well as liquidity requirements. As these securities are readily marketable and are viewed by the Company as available to support current operations, securities with maturities beyond 12 months are classified as current assets. Due to their short-term maturities, the Company believes that the fair value of its bank deposits, accounts payable and accrued expenses approximate their carrying value. Fair Value Measurements Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Three levels of inputs, of which the first two are considered observable and the last unobservable, may be used to measure fair value. The three levels are: · Level 1 — Quoted prices in active markets for identical assets or liabilities. · Level 2 — Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. · Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The following table represents the fair value hierarchy for our cash equivalents and available-for-sale securities by major security type (in thousands): As of September 30, 2018 Level 1 Level 2 Level 3 Total Cash and money market funds $ 58,022 $ — $ — $ 58,022 U.S. Treasury securities 14,357 — — 14,357 Corporate debt securities — 42,739 — 42,739 Total $ 72,379 $ 42,739 $ — $ 115,118 As of December 31, 2017 Level 1 Level 2 Level 3 Total Cash and money market funds $ 66,392 $ — $ — $ 66,392 U.S. Treasury securities 20,932 — — 20,932 Corporate debt securities — 139,011 — 139,011 Total $ 87,324 $ 139,011 $ — $ 226,335 |
Accounts Receivable
Accounts Receivable | 9 Months Ended |
Sep. 30, 2018 | |
ACCOUNTS RECEIVABLE | |
ACCOUNTS RECEIVABLE | 5. ACCOUNTS RECEIVABLE Accounts receivable consist of the following (in thousands): Balance as of September 30, December 31, 2018 2017 Qsymia $ 11,514 $ 10,400 PANCREAZE 11,126 — STENDRA/SPEDRA 1,158 1,982 23,798 12,382 Qsymia allowance for cash discounts (173) (195) Net $ 23,625 $ |
Inventories
Inventories | 9 Months Ended |
Sep. 30, 2018 | |
INVENTORIES | |
INVENTORIES | 6. INVENTORIES Inventories consist of the following (in thousands): Balance as of September 30, December 31, 2018 2017 Raw materials $ 15,383 $ 13,663 Work-in-process 1,815 2,264 Finished goods 4,405 1,785 Inventories $ 21,603 $ 17,712 Raw materials inventories consist primarily of the active pharmaceutical ingredients, or API, for Qsymia and STENDRA/SPEDRA. At December 31, 2017, work-in-process and finished goods inventory consist of Qsymia and STENDRA/SPEDRA and, at September 30, 2018, also included PANCREAZE inventory. Inventories are stated at the lower of cost or net realizable value. Cost is determined using the first in, first out method for all inventories, which are valued using a weighted-average cost method calculated for each production batch. The Company periodically evaluates the carrying value of inventory on hand for potential excess amounts over demand using the same lower of cost or net realizable value approach as that used to value the inventory. |
Prepaid Expenses And Other Curr
Prepaid Expenses And Other Current Assets | 9 Months Ended |
Sep. 30, 2018 | |
OTHER CURRENT ASSETS | |
PREPAID EXPENSES AND OTHER ASSETS | 7. Prepaid expenses and other current assets consist of the following (in thousands): Balance as of September 30, December 31, 2018 2017 Prepaid sales and marketing expenses $ 1,579 $ 1,538 Taxes receivable 2,008 1,222 Prepaid insurance 149 1,124 Other prepaid expenses and assets 4,008 3,294 Total $ 7,744 $ 7,178 These costs have been deferred as prepaid expenses and other current assets on the condensed consolidated balance sheets and will be either (i) charged to expense accordingly when the related prepaid services are rendered to the Company, or (ii) converted to cash when the receivable is collected by the Company. The amounts included in other prepaid expenses and assets consist primarily of prepayments for future services, non-trade receivables, prepaid interest and interest income receivable. |
Non-Current Assets
Non-Current Assets | 9 Months Ended |
Sep. 30, 2018 | |
NON-CURRENT ASSETS | |
NON-CURRENT ASSETS | 8. INTANGIBLE AND OTHER NON-CURRENT ASSETS Intangible and other non-current assets consist of the following (in thousands): September 30, 2018 December 31, 2017 Cost Accumulated Amortization Net Cost Accumulated Amortization Net PANCREAZE license (1) $ 141,895 $ (4,730) $ 137,165 $ — $ — $ — Janssen patents (2) 3,050 (2,506) 544 3,050 (2,235) 815 Other non-current assets 209 — 209 199 — 199 Total $ 145,154 $ (7,236) $ 137,918 $ 3,249 $ (2,235) $ 1,014 _________________ (1) In June 2018, the Company acquired the rights to license PANCREAZE in the U.S. and Canada, as described further in Note 12. The rights are being amortized over their estimated useful life of 10 years using the straight-line method. (2) In September 2014, the Company acquired certain patents relating to Qsymia from Janssen Pharmaceuticals, approximately $3.1 million of which was recorded as an intangible asset. The patents are being amortized over their estimated useful life of 5.5 years using the straight-line method. Other non-current assets primarily consist of real estate deposits. Amortization of intangible assets was $3.6 million and $5.0 million for the three and nine months ended September 30, 2018, respectively. Amortization of intangible assets was $91,000 and $0.5 million for the three and nine months ended September 30, 2017, respectively. Future expected amortization expenses for intangible assets as of September 30, 2018 are as follows (in thousands): 2018 (remainder) $ 3,639 2019 14,552 2020 14,280 2021 14,190 2022 14,190 Thereafter 76,858 Total $ 137,709 |
Accrued And Other Liabilities
Accrued And Other Liabilities | 9 Months Ended |
Sep. 30, 2018 | |
ACCRUED AND OTHER LIABILITIES | |
ACCRUED AND OTHER LIABILITIES | 9. Accrued and other liabilities consist of the following (in thousands): Balance as of September 30, December 31, 2018 2017 Accrued employee compensation and benefits $ 2,765 $ 3,642 Reserve for product returns (see Note 2) 12,995 7,854 Product-related accruals (see Note 2) 6,235 5,751 Accrued interest on debt (see Note 13) 1,730 410 Accrued manufacturing costs 5,679 1,238 Other accrued liabilities 2,520 2,580 Total $ 31,924 $ 21,475 The amounts included in other accrued liabilities consist of obligations primarily related to sales, marketing, research, clinical development, corporate activities, the STENDRA license and royalties. |
Non-Current Accrued And Other L
Non-Current Accrued And Other Liabilities | 9 Months Ended |
Sep. 30, 2018 | |
NON-CURRENT ACCRUED AND OTHER LIABILITIES | |
NON-CURRENT ACCRUED AND OTHER LIABILITIES | 10. NON-CURRENT ACCRUED AND OTHER LIABILITIES Non-current accrued and other liabilities at September 30, 2018 and December 31, 2017 were primarily comprised of deferred rent and security deposits. |
Deferred Revenue
Deferred Revenue | 9 Months Ended |
Sep. 30, 2018 | |
DEFERRED REVENUE | |
DEFERRED REVENUE | 11. Deferred revenue relates to a prepayment for future royalties on sales of SPEDRA. In the three and nine months ended September 30, 2018, the Company recorded $0.3 million and $0.9 million, respectively, of revenues which had been deferred as of December 31, 2017. These amounts were applied against the prepayment for future royalties. |
License, Commercialization And
License, Commercialization And Supply Agreements | 9 Months Ended |
Sep. 30, 2018 | |
LICENSE, COMMERCIALIZATION AND SUPPLY AGREEMENTS | |
LICENSE, COMMERCIALIZATION AND SUPPLY AGREEMENTS | 12. LICENSE, COMMERCIALIZATION AND SUPPLY AGREEMENTS MTPC In January 2001, the Company entered into an exclusive development, license and clinical trial and commercial supply agreement with Tanabe Seiyaku Co., Ltd., now Mitsubishi Tanabe Pharma Corporation, or MTPC, for the development and commercialization of avanafil. Under the terms of the agreement, MTPC agreed to grant an exclusive license to the Company for products containing avanafil outside of Japan, North Korea, South Korea, China, Taiwan, Singapore, Indonesia, Malaysia, Thailand, Vietnam and the Philippines. The Company agreed to grant MTPC an exclusive, royalty free license within those countries for oral products that we develop containing avanafil. The MTPC agreement contains a number of milestone payments to be made by us based on various triggering events. The term of the MTPC agreement is based on a country by country and on a product by product basis. In August 2012, the Company entered into an amendment to the agreement with MTPC that permitted the Company to manufacture the API and tablets for STENDRA by itself or through third parties. In 2015, the Company transferred the manufacturing of the API and tablets for STENDRA to Sanofi. The Company maintains royalty obligations to MTPC which have been passed through to our commercialization partners. Menarini In July 2013, the Company entered into a license and commercialization agreement, or the Menarini License Agreement, and a supply agreement, or the Menarini Supply Agreement, with the Menarini Group through its subsidiary Berlin Chemie AG, or Menarini. Under the terms of the Menarini License Agreement, Menarini received an exclusive license to commercialize and promote SPEDRA for the treatment of ED in over 40 countries, including the EU, plus Australia and New Zealand. Additionally, the Company transferred to Menarini ownership of the marketing authorization for SPEDRA in the EU for the treatment of ED, which was granted by the EC in June 2013. Under the Menarini License Agreement, the Company has and is entitled to receive milestone payments based on certain net sales targets, plus royalties on SPEDRA sales. Under the terms of the Menarini Supply Agreement, the Company will supply Menarini with SPEDRA drug product until December 31, 2018. Menarini also has the right to manufacture SPEDRA independently, provided that it continues to satisfy certain minimum purchase obligations to the Company. Following the expiration of the Menarini Supply Agreement, Menarini will be responsible for its own supply of SPEDRA. Either party may terminate the Menarini Supply Agreement for the other party’s uncured material breach or bankruptcy, or upon the termination of the Menarini License Agreement. Sanofi In December 2013, the Company entered into a license and commercialization agreement, or the Sanofi License Agreement, with Sanofi. Under the terms of the Sanofi License Agreement, Sanofi received an exclusive license to commercialize and promote avanafil for therapeutic use in humans in Africa, the Middle East—Turkey and Commonwealth of Independent States, including Russia, or the Sanofi Territory. In July 2013, the Company entered into a Commercial Supply Agreement with Sanofi Chimie to manufacture and supply the API for avanafil on an exclusive basis in the United States and other territories and on a semi-exclusive basis in Europe, including the EU, Latin America and other territories. In November 2013, the Company entered into a Manufacturing and Supply Agreement with Sanofi Winthrop Industrie to manufacture and supply the avanafil tablets on an exclusive basis in the United States and other territories and on a semi exclusive basis in Europe, including the EU, Latin America and other territories. The Company has minimum annual purchase commitments under these agreements for at least the initial five-year term. On March 23, 2017, the Company and Sanofi entered into the Termination, Rights Reversion and Transition Services Agreement, or the Transition Agreement, effective February 28, 2017. Under the Transition Agreement, effective upon the thirtieth (30th) day following February 28, 2017, the Sanofi License Agreement terminated for all countries in the Sanofi Territory. In addition, under the Transition Agreement, Sanofi provides the Company with certain transition services in support of ongoing regulatory approval efforts while the Company seeks to obtain a new commercial partner or partners for the Sanofi Territory. The Company pays certain transition service fees to Sanofi as part of the Transition Agreement. Metuchen On September 30, 2016, the Company entered into a license and commercialization agreement, or the Metuchen License Agreement, and a commercial supply agreement, or the Metuchen Supply Agreement, with Metuchen Pharmaceuticals LLC, or Metuchen. Under the terms of the Metuchen License Agreement, Metuchen received an exclusive license to develop, commercialize and promote STENDRA in the United States, Canada, South America and India, or the Metuchen Territory, effective October 1, 2016. The Company and Metuchen have agreed not to develop, commercialize, or in-license any other product that operates as a PDE-5 inhibitor in the Metuchen Territory for a limited time period, subject to certain exceptions. The Metuchen License Agreement will terminate upon the expiration of the last-to-expire payment obligations under the Metuchen License Agreement; upon expiration of the term of the Metuchen License Agreement, the exclusive license granted under the Metuchen License Agreement shall become fully paid-up, royalty-free, perpetual and irrevocable as to the Company but not certain trademark royalties due to MTPC. Metuchen will obtain STENDRA exclusively from the Company for a mutually agreed term pursuant to the Metuchen Supply Agreement. Metuchen may elect to transfer the control of the supply chain for STENDRA for the Metuchen Territory to itself or its designee by assigning to Metuchen the Company’s agreements with the contract manufacturer. For 2016 and each subsequent calendar year during the term of the Metuchen Supply Agreement, if Metuchen fails to purchase an agreed minimum purchase amount of STENDRA from the Company, it will reimburse the Company for the shortfall as it relates to the Company’s out of pocket costs to acquire certain raw materials needed to manufacture STENDRA. Upon the termination of the Metuchen Supply Agreement (other than by Metuchen for the Company’s uncured material breach or upon completion of the transfer of the control of the supply chain), Metuchen’s agreed minimum purchase amount of STENDRA from the Company shall accelerate for the entire then current initial term or renewal term, as applicable. The initial term under the Metuchen Supply Agreement will be for a period of five years, with automatic renewal for successive two-year periods unless either party provides a termination notice to the other party at least two years in advance of the expiration of the then current term. Alvogen In September 2017, the Company entered into a license and commercialization agreement, or the Alvogen License Agreement, and a commercial supply agreement, or the Alvogen Supply Agreement, with Alvogen Malta Operations (ROW) Ltd, or Alvogen. Under the terms of the Alvogen License Agreement, Alvogen will be solely responsible for obtaining and maintaining regulatory approvals for all sales and marketing activities for Qsymia in South Korea. The Company received an upfront payment of $2.5 million in September 2017, which was recorded in license and milestone revenue in the third quarter of 2017, and is eligible to receive additional payments upon Alvogen achieving marketing authorization, commercial launch and reaching a sales milestone. Additionally, the Company will receive a royalty on Alvogen’s Qsymia net sales in South Korea. Under the Alvogen Supply Agreement, the Company will supply product to Alvogen. PANCREAZE In June 2018, the Company closed on an Asset Purchase Agreement, or the PANCREAZE Purchase Agreement, with Janssen Pharmaceuticals, Inc., or Janssen, pursuant to which the Company acquired the rights to PANCREAZE and PANCREASE MT in the U.S. and Canada and certain existing inventory for a purchase price of $135.0 million in cash. Related to the acquisition, the Company also acquired all of the outstanding shares of Willow Biopharma Inc., or Willow. Willow had no significant assets at the time of acquisition. The Company issued fully-exercisable warrants to the former owners of Willow for the purchase of 357,000 shares of the Company’s common stock at an exercise price of $3.70 per share and agreed to assume certain of Willow’s liabilities. The amounts paid to the former owners were accounted for as a fee for the acquisition of PANCREAZE. As all the PANCREAZE assets acquired were a part of one product line, the PANCREAZE Purchase Agreement was accounted for as an asset acquisition, with an intangible asset of $141.9 million for the PANCREAZE license recorded on the balance sheet, which was comprised of the purchase price of $135.0 million, the fair value of the warrants issued of $0.8 million, the value of liabilities assumed of $0.4 million, the value of the Willow liabilities assumed of $1.5 million and accruals for estimated destruction of future unsalable inventory of $6.3 million, less the net value of PANCREAZE inventory acquired of $2.1 million. The fair value of the warrants issued was estimated using the Black-Scholes option pricing model, using a term of 7.0 years, an estimated volatility of 61.6%, a risk-free interest rate of 2.91% and an expected dividend yield of 0%. The intangible asset is being amortized over an expected useful life of 10 years, which corresponds with the expiration of certain significant patent rights related to PANCREAZE. In connection with the PANCREAZE Purchase Agreement, the Company and Janssen also entered into transition services agreements pursuant to which Janssen and a Canadian affiliate of Janssen will provide certain transition services to the Company in the U.S. and Canada as the Company transitions to full control over the PANCREAZE supply chain. The Company and Johnson & Johnson Health Care Systems Inc., a New Jersey corporation and an affiliate of Janssen, also entered into a Long-Term Collaboration Agreement pursuant to which they will cooperate in the reporting and certification of pricing and sales data and the payment of rebates and discounts under certain governmental programs. |
Long-Term Debt And Commitments
Long-Term Debt And Commitments | 9 Months Ended |
Sep. 30, 2018 | |
LONG-TERM DEBT AND COMMITMENTS | |
LONG-TERM DEBT AND COMMITMENTS | 13. LONG-TERM DEBT AND COMMITMENTS The Company’s indebtedness consists of the following (in thousands): Balance as of September 30, December 31, 2018 2017 Senior secured notes due 2018 $ — $ 6,187 Unamortized discount and debt issuance costs — (7) Senior secured notes due 2018, net — 6,180 Convertible senior notes due 2020 190,000 250,000 Unamortized discount and debt issuance costs 3,685 (20,497) Convertible senior notes due 2020, net 193,685 229,503 Senior secured notes due 2024 110,000 — Unamortized premium and debt issuance costs, net (3,503) — Senior secured notes due 2024, net 106,497 — Total debt 300,182 235,683 Less current portion — 5,147 Total long-term debt $ 300,182 $ 230,536 Senior Secured Notes Due 2024 In June 2018, the Company entered into an indenture, or the Indenture, with U.S. Bank National Association as trustee and collateral agent regarding the purchase agreement entered into with affiliates of Athyrium Capital Management (collectively, the “Purchasers”) for the issuance and sale of (i) $110.0 million of 10.375% senior secured notes due 2024, or the Notes, (ii) up to an additional $10.0 million of 10.375% senior secured notes due 2024 to be issued subsequently at the Company’s option within 12 months of the Notes issue date, subject to certain conditions, and (iii) a warrant for 330,000 shares issued concurrently with the issuance of the Notes. The Notes were issued at a purchase price equal to 99% of the principal amount. The Notes contain customary representations, warranties, covenants, conditions and indemnities. The Company used the net proceeds from the issuance of the Notes to pay (i) certain fees, costs and expenses relating to the issuance and sale of the Notes, (ii) to finance a portion of the PANCREAZE Asset Acquisition, (iii) to repurchase $60.0 million of the Company’s outstanding 4.5% Convertible Senior Notes due 2020, or the Convertible Notes, from the Purchasers or their affiliates for a purchase price of $51.0 million (plus accrued but unpaid interest to the repurchase date) and (iv) for general corporate purposes. The fair value of the warrant issued was estimated using the Black-Scholes option pricing model, using a term of 6.0 years, an estimated volatility of 62.7%, a risk-free interest rate of 2.83% and an expected dividend yield of 0%. The Indenture has an effective interest rate of 11.3% and includes customary covenants and events of default, including covenants that, among other things, restrict the incurrence of future indebtedness, the granting of liens, the making of investments, distributions or dividends, and the Company’s ability to merge, consolidate or sell assets, in each case subject to certain exceptions. In addition, the Indenture includes certain financial maintenance covenants related to minimum cash balances and minimum quarterly net revenues related to PANCREAZE. Future estimated payments on all of the Company’s indebtedness as of September 30, 2018 are as follows (in thousands): 2018 (remainder) $ 7,128 2019 19,963 2020 206,163 2021 36,131 2022 41,299 Thereafter 55,400 $ 366,084 Cardiovascular Outcomes Trial As a condition of FDA granting approval to commercialize Qsymia in the U.S., the Company agreed to complete certain post-marketing requirements. One requirement was to perform a cardiovascular outcomes trial, or CVOT, on Qsymia. The cost of a CVOT is estimated to be between $180.0 million and $220.0 million incurred over a period of approximately five years. The Company is working with FDA to significantly reduce or remove the requirements of the CVOT. To date, the Company has not incurred expenses related to the CVOT. |
Net Income (Loss) Per Share
Net Income (Loss) Per Share | 9 Months Ended |
Sep. 30, 2018 | |
NET INCOME (LOSS) PER SHARE | |
NET INCOME (LOSS) PER SHARE | 14. NET LOSS PER SHARE The Company computes basic net loss per share applicable to common stockholders based on the weighted average number of common shares outstanding during the applicable period. Diluted net income per share is based on the weighted average number of common and common equivalent shares, which represent shares that may be issued in the future upon the exercise of outstanding stock options or upon a net share settlement of the Company’s Convertible Notes. Common share equivalents are excluded from the computation in periods in which they have an anti-dilutive effect. Stock options for which the price exceeds the average market price over the period have an anti-dilutive effect on net income per share and, accordingly, are excluded from the calculation. The triggering conversion conditions that allow holders of the Convertible Notes to convert have not been met. If such conditions are met and the note holders opt to convert, the Company may choose to pay in cash, common stock, or a combination thereof; however, if this occurs, the Company has the intent and ability to net share settle this debt security; thus the Company uses the treasury stock method for earnings per share purposes. Due to the effect of the capped call instrument purchased in relation to the Convertible Notes, there would be no net shares issued until the market value of the Company’s stock exceeds $200 per share, and thus no impact on diluted net income per share. Further, when there is a net loss, potentially dilutive common equivalent shares are not included in the calculation of net loss per share since their inclusion would be anti-dilutive. As the Company recognized a net loss for each of the three-month periods ended September 30, 2018 and 2017, all potential common equivalent shares were excluded for these periods as they were anti-dilutive. Awards and options which were not included in the computation of diluted net loss per share because the effect would be anti-dilutive were 1,499,000 and 1,399,000, respectively, for the three months ended September 30, 2018 and 2017 and 1,629,000 and 1,330,000, respectively, for the nine months ended September 30, 2018 and 2017. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2018 | |
INCOME TAXES | |
INCOME TAXES | 15. INCOME TAXES For the three and nine months ended September 30, 2018, the Company recorded a provision for income taxes of $36,000 and $52,000, respectively. For the three and nine months ended September 30, 2017, the Company recorded a provision of $8,000 and a benefit of $3,000, respectively. The benefit and provision for income taxes for each of the periods was primarily comprised of state taxes during the period. The Company periodically evaluates the realizability of its net deferred tax assets based on all available evidence, both positive and negative. The realization of net deferred tax assets is dependent on the Company’s ability to generate sufficient future taxable income during periods prior to the expiration of tax attributes to fully utilize these assets. The Company weighed both positive and negative evidence and determined that there is a continued need for a full valuation allowance on its deferred tax assets in the United States as of September 30, 2018. Should the Company determine that it would be able to realize its remaining deferred tax assets in the foreseeable future, an adjustment to its remaining deferred tax assets would cause a material increase to income in the period such determination is made. As of September 30, 2018, the Company’s unrecognized tax benefits were related to federal and California research and development credits which result in an unrecognized tax benefit balance of $144,000. The Company does not expect to have any other significant changes to unrecognized tax benefits through the end of the fiscal year. Because of the Company’s history of tax losses, certain tax years remain open to tax audit. The Company’s policy is to recognize interest and penalties related to uncertain tax positions (if any) as a component of the income tax provision. |
Legal Matters
Legal Matters | 9 Months Ended |
Sep. 30, 2018 | |
LEGAL MATTERS | |
LEGAL MATTERS | 16. LEGAL MATTERS The Company is not aware of any asserted or unasserted claims against it where it believes that an unfavorable resolution would have an adverse material impact on the operations or financial position of the Company . |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2018 | |
SUBSEQUENT EVENTS | |
SUBSEQUENT EVENTS | 17. SUBSEQUENT EVENTS On October 11, 2018, the Company entered into a first supplemental indenture, or the First Supplemental Indenture, to its Indenture, which is further described in Note 13. The First Supplemental Indenture amended the Indenture to provide, among other things, additional capacity for the Company to repurchase up to $20.0 million aggregate principal amount of its outstanding Convertible Notes from time to time prior to May 31, 2019. On October 17, 2018, the Company settled a purchase of approximately $8.6 million outstanding principal amount of its Convertible Notes from a holder in a private transaction for $7.1 million plus all accrued but unpaid interest. |
Business And Significant Polici
Business And Significant Policies (Policies) | 9 Months Ended |
Sep. 30, 2018 | |
BASIS OF PRESENTATION | |
Use of Estimates | Use of Estimates The preparation of these unaudited condensed consolidated financial statements requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues, expenses and related disclosures. On an ongoing basis, the Company evaluates its estimates, including critical accounting policies or estimates related to available-for-sale securities, debt instruments, research and development expenses, income taxes, inventories, revenues, contingencies and litigation and share-based compensation. The Company bases its estimates on historical experience, information received from third parties and on various market specific and other relevant assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ significantly from those estimates under different assumptions or conditions. |
Recent Accounting Pronouncements | Recent Accounting Pronouncement Adopted In May 2014, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers . This standard is a comprehensive new revenue recognition model that requires revenue to be recognized in a manner to depict the transfer of goods or services to a customer at an amount that reflects the consideration expected to be received in exchange for those goods or services. This new standard supersedes most previously-existing revenue recognition guidance. The Company adopted this standard in January 2018 using the modified retrospective basis. See Note 2. In August 2016, the FASB issued Accounting Standards Update 2016-15, Statement of Cash Flows (Topic 230) Classification of Certain Cash Receipts and Cash Payments . The standard clarifies how certain cash receipts and cash payments will be presented and classified in the statement of cash flows. The Company adopted this standard in January 2018, and it had no impact on its consolidated financial statements. Recent Accounting Pronouncements Not Yet Adopted In February 2016, the FASB issued Accounting Standards Update 2016-02, Leases (Topic 842), which modifies the accounting by lessees for all leases with a term greater than 12 months. This standard will require lessees to recognize on the balance sheet the assets and liabilities for the rights and obligations created by those leases. For public companies, this standard is effective for annual and interim periods beginning on or after December 15, 2018. Early adoption is permitted, but the Company intends to adopt this guidance effective January 1, 2019 using a modified retrospective transition method, not adjusting comparative periods. The Company’s only significant lease is its operating lease for its corporate headquarters, although it has several smaller leases. The Company is completing its analysis, but expects the adoption of this guidance to have a significant impact on its balance sheets as it will recognize right of use assets and corresponding lease liabilities. The Company expects the impact on accumulated deficit to be minimal. The Company expects the overall ongoing recognition of expense to be similar to current guidance, though the classification of such expense could be significantly different. |
Revenue Recognition | Revenue Recognition For all revenue transactions, the Company evaluates its contracts with its customers to determine revenue recognition using the following five-step model: 1) 2) 3) 4) 5) Product Revenue Product revenue is recognized at the time of shipment at which time the Company has satisfied its performance obligation. Product revenue is recognized net of consideration paid to the Company’s customers, wholesalers and certified pharmacies. Such consideration is for services rendered by the wholesalers and pharmacies in accordance with the wholesalers and certified pharmacy services network agreements, and includes a fixed rate per prescription shipped and monthly program management and data fees. These services are not deemed sufficiently separable from the customers’ purchase of the product; therefore, they are recorded as a reduction of revenue at the time of revenue recognition. Other product revenue allowances include a reserve for estimated product returns, certain prompt pay discounts and allowances offered to the Company’s customers, program rebates and chargebacks. These product revenue allowances are recognized as a reduction of revenue at the date at which the related revenue is recognized. The Company also offers discount programs to patients. Calculating certain of these items involves estimates and judgments based on sales or invoice data, contractual terms, utilization rates, new information regarding changes in these programs’ regulations and guidelines that would impact the amount of the actual rebates or chargebacks. The Company reviews the adequacy of product revenue allowances on a quarterly basis. Amounts accrued for product revenue allowances are adjusted when trends or significant events indicate that adjustment is appropriate and to reflect actual experience. See Note 9 for product reserve balances. Change in Accounting Estimate in 2017 The Company ships units of Qsymia through a distribution network that includes certified retail pharmacies. The Company began shipping Qsymia in September 2012 and grants rights to its customers to return unsold product from six months prior to and up to 12 months subsequent to product expiration. This has resulted in a potential return period of from 24 to 36 months depending on the ship date of the product. As the Company had no previous experience in selling Qsymia and given its lengthy return period, the Company was not initially able to reliably estimate expected returns of Qsymia at the time of shipment, which was required by the accounting literature at the time, and therefore recognized revenue when units were dispensed to patients through prescriptions, at which point the product was not subject to return, or when the expiration period had ended. Beginning in the first quarter of 2017, with 48 months of returns experience, the Company believed that it had sufficient data and experience from selling Qsymia to reliably estimate expected returns. Therefore, beginning in the first quarter of 2017, under the then relevant accounting literature, the Company began recognizing revenue from the sales of Qsymia upon shipment and recording a reserve for expected returns at the time of shipment. In accordance with this change in accounting estimate, in the first quarter of 2017 the Company recognized a one-time adjustment relating to products that had been previously shipped, consisting of $17.9 million of gross revenues, adjusted for an expected returns reserve of $5.7 million and estimated gross-to-net charges of $4.9 million, for a net impact of $7.3 million in revenues. The Company also recorded increased cost of goods sold of $0.6 million and marketing expense of $0.7 million associated with the change in accounting estimate. The increase in net product revenue resulted in a decrease in net loss of $6.0 million or $0.57 per share for the nine months ended September 30, 2017. Supply Revenue The Company produces STENDRA/SPEDRA through a contract manufacturing partner and then sells it to the Company’s commercialization partners. The Company is the primary responsible party in the commercial supply arrangements and bears significant risk in the fulfillment of the obligations, including risks associated with manufacturing, regulatory compliance and quality assurance, as well as inventory, financial and credit loss. As such, the Company recognizes supply revenue on a gross basis as the principal party in the arrangements. The Company recognizes supply revenue at the time of shipment and, in the unusual case where the product does not meet contractually-specified product dating criteria at the time of shipment to the partner, the Company records a reserve for estimated product returns. There are no such reserves as of September 30, 2018. License and Milestone Revenue License and milestone revenues related to arrangements, usually license and/or supply agreements, entered into by the Company are recognized by following the five-step process outlined above. The allocation and timing of recognition of such revenue will be determined by that process and the amounts recognized and the timing of that recognition may not exactly follow the wording of the agreement as the amount allocated following the accounting analysis of the agreement may differ and the timing of recognition of a significant performance obligation may predate the contractual date. Royalty Revenue The Company relies on data provided by its collaboration partner in determining its contractually-based royalty revenue. Such data includes accounting estimates and reports for various discounts and allowances, including product returns. The Company records royalty revenues based on the best data available and makes any adjustments to such revenues as such information becomes available. |
Available-for-Sale Securities | As of September 30, 2018, the Company’s available-for-sale securities had original contractual maturities up to 57 months. However, the Company may sell these securities prior to their stated maturities in response to changes in the availability of and the yield on alternative investments as well as liquidity requirements. As these securities are readily marketable and are viewed by the Company as available to support current operations, securities with maturities beyond 12 months are classified as current assets. Due to their short-term maturities, the Company believes that the fair value of its bank deposits, accounts payable and accrued expenses approximate their carrying value. |
Inventories | Inventories are stated at the lower of cost or net realizable value. Cost is determined using the first in, first out method for all inventories, which are valued using a weighted-average cost method calculated for each production batch. The Company periodically evaluates the carrying value of inventory on hand for potential excess amounts over demand using the same lower of cost or net realizable value approach as that used to value the inventory |
Income Taxes | The Company’s policy is to recognize interest and penalties related to uncertain tax positions (if any) as a component of the income tax provision. |
Revenue (Tables)
Revenue (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
REVENUE INFORMATION | |
Schedule of net product revenue by geographic region | Revenue by Source and Geography Revenue disaggregated by revenue source and by geographic region was as follows (in thousands): Three Months Ended September 30, 2018 2017 U.S. ROW Total U.S. ROW Total Qsymia—Net product revenue $ 9,737 $ — $ 9,737 $ 9,911 $ — $ 9,911 Qsymia—License revenue — — — — 2,500 2,500 PANCREAZE - Net product revenue 6,747 — 6,747 — — — PANCREAZE - Royalty revenue — 576 576 — — — STENDRA/SPEDRA—Supply revenue — 478 478 1,070 1,063 2,133 STENDRA/SPEDRA—Royalty revenue — 550 550 — 649 649 Total revenue $ 16,484 $ 1,604 (1) $ 18,088 $ 10,981 $ 4,212 (2) $ 15,193 Nine Months Ended September 30, 2018 2017 U.S. ROW Total U.S. ROW Total Qsymia—Net product revenue $ 30,503 $ — $ 30,503 $ 36,049 $ — $ 36,049 Qsymia—License revenue — — — 5,000 2,500 7,500 PANCREAZE - Net product revenue 8,863 — 8,863 — — — PANCREAZE - Royalty revenue — 650 650 — — — STENDRA/SPEDRA—Supply revenue 1,071 2,132 3,203 4,845 3,219 8,064 STENDRA/SPEDRA—Royalty revenue — 1,729 1,729 — 1,819 1,819 Total revenue $ 40,437 $ 4,511 (3) $ 44,948 $ 45,894 $ 7,538 (4) $ 53,432 (1) $1.0 million of which was attributable to Germany and $0.6 million of which was attributable to Canada. (2) $1.7 million of which was attributable to Germany and $2.5 million of which was attributable to South Korea. (3) $3.9 million of which was attributable to Germany and $0.6 million of which was attributable to Canada. (4) $5.0 million of which was attributable to Germany and $2.5 million of which was attributable to South Korea. |
Schedule of Revenue And Cost Of Goods Sold By Source | Three Months Ended September 30, 2018 2017 Qsymia PANCREAZE STENDRA/ SPEDRA Total Qsymia STENDRA/ SPEDRA Total Net product revenue $ 9,737 $ 6,747 $ — $ 16,484 $ 9,911 $ — $ 9,911 License — — — — 2,500 — 2,500 Supply revenue — — 478 478 — 2,133 2,133 Royalty revenue — 576 550 1,126 — 649 649 Total revenue $ 9,737 $ 7,323 $ 1,028 $ 18,088 $ 12,411 $ 2,782 $ 15,193 Cost of goods sold (excluding amortization) $ 953 $ 2,006 $ 525 $ 3,484 $ 1,428 $ 1,995 $ 3,423 Amortization of intangible assets $ 91 $ 3,547 $ — $ 3,638 $ 91 $ — $ 91 Nine Months Ended September 30, 2018 2017 Qsymia PANCREAZE STENDRA/ SPEDRA Total Qsymia STENDRA/ SPEDRA Total Net product revenue $ 30,503 $ 8,863 $ — $ 39,366 $ 36,049 $ — $ 36,049 License — — — — 7,500 — 7,500 Supply revenue — — 3,203 3,203 — 8,064 8,064 Royalty revenue — 650 1,729 2,379 — 1,819 1,819 Total revenue $ 30,503 $ 9,513 $ 4,932 $ 44,948 $ 43,549 $ 9,883 $ 53,432 Cost of goods sold (excluding amortization) $ 3,648 $ 2,574 $ 3,178 $ 9,400 $ 5,311 $ 7,487 $ 12,798 Amortization of intangible assets $ 272 $ 4,730 $ — $ 5,002 $ 453 $ — $ 453 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
SHARE-BASED COMPENSATION. | |
Schedule of share-based compensation expense | Total share-based compensation expense for all of the Company’s share-based awards was as follows (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2018 2017 2018 2017 Cost of goods sold $ 18 $ 13 $ 48 $ 41 Selling, general and administrative 581 2,368 Research and development 77 234 Total share-based compensation expense $ $ $ $ |
Cash, Cash Equivalents, And A_2
Cash, Cash Equivalents, And Available-For-Sale Securities (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
CASH, CASH EQUIVALENTS, AND AVAILABLE-FOR-SALE SECURITIES | |
Schedule of fair value and amortized cost of cash, cash equivalents, and available-for-sale securities by major security type | As of September 30, 2018 Gross Gross Amortized Unrealized Unrealized Estimated Cash and cash equivalents and available-for-sale securities Cost Gains Losses Fair Value Cash and money market funds $ 58,022 $ — $ — $ 58,022 U.S. Treasury securities 14,513 — (156) 14,357 Corporate debt securities 42,982 6 (249) 42,739 Total 115,517 6 (405) 115,118 Less amounts classified as cash and cash equivalents (58,022) — — (58,022) Total available-for-sale securities $ 57,495 $ 6 $ (405) $ 57,096 As of December 31, 2017 Gross Gross Amortized Unrealized Unrealized Estimated Cash and cash equivalents and available-for-sale securities Cost Gains Losses Fair Value Cash and money market funds $ 66,392 $ — $ — $ 66,392 U.S. Treasury securities 21,070 1 (139) 20,932 Corporate debt securities 139,481 16 (486) 139,011 Total 226,943 17 (625) 226,335 Less amounts classified as cash and cash equivalents (66,392) — — (66,392) Total available-for-sale securities $ 160,551 $ 17 $ (625) $ 159,943 |
Schedule of Fair Value of Separate Accounts by Major Category of Investment | The following table represents the fair value hierarchy for our cash equivalents and available-for-sale securities by major security type (in thousands): As of September 30, 2018 Level 1 Level 2 Level 3 Total Cash and money market funds $ 58,022 $ — $ — $ 58,022 U.S. Treasury securities 14,357 — — 14,357 Corporate debt securities — 42,739 — 42,739 Total $ 72,379 $ 42,739 $ — $ 115,118 As of December 31, 2017 Level 1 Level 2 Level 3 Total Cash and money market funds $ 66,392 $ — $ — $ 66,392 U.S. Treasury securities 20,932 — — 20,932 Corporate debt securities — 139,011 — 139,011 Total $ 87,324 $ 139,011 $ — $ 226,335 |
Accounts Receivable (Tables)
Accounts Receivable (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
ACCOUNTS RECEIVABLE | |
Schedule of accounts receivable | Accounts receivable consist of the following (in thousands): Balance as of September 30, December 31, 2018 2017 Qsymia $ 11,514 $ 10,400 PANCREAZE 11,126 — STENDRA/SPEDRA 1,158 1,982 23,798 12,382 Qsymia allowance for cash discounts (173) (195) Net $ 23,625 $ |
Inventories (Tables)
Inventories (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
INVENTORIES | |
Schedule of inventories | Inventories consist of the following (in thousands): Balance as of September 30, December 31, 2018 2017 Raw materials $ 15,383 $ 13,663 Work-in-process 1,815 2,264 Finished goods 4,405 1,785 Inventories $ 21,603 $ 17,712 |
Prepaid Expenses And Other Cu_2
Prepaid Expenses And Other Current Assets (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
OTHER CURRENT ASSETS | |
Schedule of prepaid expenses and other assets | Prepaid expenses and other current assets consist of the following (in thousands): Balance as of September 30, December 31, 2018 2017 Prepaid sales and marketing expenses $ 1,579 $ 1,538 Taxes receivable 2,008 1,222 Prepaid insurance 149 1,124 Other prepaid expenses and assets 4,008 3,294 Total $ 7,744 $ 7,178 |
Intangibles and Noncurrent Asse
Intangibles and Noncurrent Assets (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
NON-CURRENT ASSETS | |
Schedule of Finite-Lived Intangible Assets And Other Noncurrent Assets | Intangible and other non-current assets consist of the following (in thousands): September 30, 2018 December 31, 2017 Cost Accumulated Amortization Net Cost Accumulated Amortization Net PANCREAZE license (1) $ 141,895 $ (4,730) $ 137,165 $ — $ — $ — Janssen patents (2) 3,050 (2,506) 544 3,050 (2,235) 815 Other non-current assets 209 — 209 199 — 199 Total $ 145,154 $ (7,236) $ 137,918 $ 3,249 $ (2,235) $ 1,014 _________________ (1) In June 2018, the Company acquired the rights to license PANCREAZE in the U.S. and Canada, as described further in Note 12. The rights are being amortized over their estimated useful life of 10 years using the straight-line method. (2) In September 2014, the Company acquired certain patents relating to Qsymia from Janssen Pharmaceuticals, approximately $3.1 million of which was recorded as an intangible asset. The patents are being amortized over their estimated useful life of 5.5 years using the straight-line method. |
Future Expected Amortization Expenses For Intangible Assets | Future expected amortization expenses for intangible assets as of September 30, 2018 are as follows (in thousands): 2018 (remainder) $ 3,639 2019 14,552 2020 14,280 2021 14,190 2022 14,190 Thereafter 76,858 Total $ 137,709 |
Accrued And Other Liabilities (
Accrued And Other Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
ACCRUED AND OTHER LIABILITIES | |
Schedule of accrued and other liabilities | Accrued and other liabilities consist of the following (in thousands): Balance as of September 30, December 31, 2018 2017 Accrued employee compensation and benefits $ 2,765 $ 3,642 Reserve for product returns (see Note 2) 12,995 7,854 Product-related accruals (see Note 2) 6,235 5,751 Accrued interest on debt (see Note 13) 1,730 410 Accrued manufacturing costs 5,679 1,238 Other accrued liabilities 2,520 2,580 Total $ 31,924 $ 21,475 |
Long-Term Debt (Tables)
Long-Term Debt (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
LONG-TERM DEBT AND COMMITMENTS | |
Schedule of debt | The Company’s indebtedness consists of the following (in thousands): Balance as of September 30, December 31, 2018 2017 Senior secured notes due 2018 $ — $ 6,187 Unamortized discount and debt issuance costs — (7) Senior secured notes due 2018, net — 6,180 Convertible senior notes due 2020 190,000 250,000 Unamortized discount and debt issuance costs 3,685 (20,497) Convertible senior notes due 2020, net 193,685 229,503 Senior secured notes due 2024 110,000 — Unamortized premium and debt issuance costs, net (3,503) — Senior secured notes due 2024, net 106,497 — Total debt 300,182 235,683 Less current portion — 5,147 Total long-term debt $ 300,182 $ 230,536 |
Schedule of Maturities of Long-term Debt | Future estimated payments on all of the Company’s indebtedness as of September 30, 2018 are as follows (in thousands): 2018 (remainder) $ 7,128 2019 19,963 2020 206,163 2021 36,131 2022 41,299 Thereafter 55,400 $ 366,084 |
Business And Significant Accoun
Business And Significant Accounting Policies (Details) | Sep. 10, 2018 | Sep. 30, 2018item |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Number of Approved Federal Drug Administration Therapies | 3 | |
Number of product candidate in active clinical development | 1 | |
one-for-10 reverse stock split of common stock | 10 |
Revenue, Narratives (Details)
Revenue, Narratives (Details) - USD ($) $ in Thousands | 1 Months Ended | 9 Months Ended | 21 Months Ended |
Sep. 30, 2012 | Sep. 30, 2018 | Sep. 30, 2018 | |
Qsymia | |||
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Months of Returns Experience | 48 months | ||
Qsymia | Minimum | |||
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Product Shelf Life Term | 6 months | ||
Potential Return Period | 24 months | ||
Qsymia | Maximum | |||
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Product Shelf Life Term | 12 months | ||
Potential Return Period | 36 months | ||
Supply agreement | STENDRA/SPEDRA | |||
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Revenue Recognition, Sales Returns, Reserve for Sales Returns | $ 0 |
Revenue, New Accounting Pronoun
Revenue, New Accounting Pronouncements (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | |||||
Sep. 30, 2018 | Sep. 30, 2017 | Mar. 31, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Jan. 01, 2018 | Dec. 31, 2017 | |
Change in Accounting Estimate [Line Items] | |||||||
Retained Earnings (Accumulated Deficit) | $ (876,015) | $ (876,015) | $ (843,565) | ||||
Net Income (Loss) Attributable to Parent | $ (9,223) | $ (5,994) | $ (32,450) | $ (20,436) | |||
Earnings Per Share, Basic and Diluted | $ (0.87) | $ (0.57) | $ (3.06) | $ (1.93) | |||
Cost of Goods Sold. | $ 3,484 | $ 3,423 | $ 9,400 | $ 12,798 | |||
Difference between Revenue Guidance in Effect before and after Topic 606 [Member] | Accounting Standards Update 2014-09 [Member] | |||||||
Change in Accounting Estimate [Line Items] | |||||||
Retained Earnings (Accumulated Deficit) | $ 0 | ||||||
Change in accounting estimate | Qsymia | |||||||
Change in Accounting Estimate [Line Items] | |||||||
Sales Revenue, Goods, Gross | $ 17,900 | ||||||
Sales Returns, Goods | 5,700 | ||||||
Sales Allowances, Goods | 4,900 | ||||||
Revenue, Net | 7,300 | ||||||
Net Income (Loss) Attributable to Parent | $ 6,000 | ||||||
Earnings Per Share, Basic and Diluted | $ 0.57 | ||||||
Cost of Goods Sold. | 600 | ||||||
Marketing Expense | $ 700 |
Revenue By Geography (Details)
Revenue By Geography (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Geographic Information | ||||
Revenues | $ 18,088 | $ 15,193 | $ 44,948 | $ 53,432 |
Qsymia | ||||
Geographic Information | ||||
Revenues | 9,737 | 12,411 | 30,503 | 43,549 |
PANCREAZE | ||||
Geographic Information | ||||
Revenues | 7,323 | 9,513 | ||
STENDRA/SPEDRA | ||||
Geographic Information | ||||
Revenues | 1,028 | 2,782 | 4,932 | 9,883 |
U.S. | ||||
Geographic Information | ||||
Revenues | 16,484 | 10,981 | 40,437 | 45,894 |
ROW | ||||
Geographic Information | ||||
Revenues | 1,604 | 4,212 | 4,511 | 7,538 |
Germany | ||||
Geographic Information | ||||
Revenues | 1,000 | 1,700 | 3,900 | 5,000 |
Canada | ||||
Geographic Information | ||||
Revenues | 600 | 600 | ||
South Korea | ||||
Geographic Information | ||||
Revenues | 2,500 | 2,500 | ||
Net Product Revenue | ||||
Geographic Information | ||||
Revenues | 16,484 | 9,911 | 39,366 | 36,049 |
Net Product Revenue | Qsymia | ||||
Geographic Information | ||||
Revenues | 9,737 | 9,911 | 30,503 | 36,049 |
Net Product Revenue | PANCREAZE | ||||
Geographic Information | ||||
Revenues | 6,747 | 8,863 | ||
Net Product Revenue | U.S. | Qsymia | ||||
Geographic Information | ||||
Revenues | 9,737 | 9,911 | 30,503 | 36,049 |
Net Product Revenue | U.S. | PANCREAZE | ||||
Geographic Information | ||||
Revenues | 6,747 | 8,863 | ||
Royalty Revenue | ||||
Geographic Information | ||||
Revenues | 1,126 | 649 | 2,379 | 1,819 |
Royalty Revenue | PANCREAZE | ||||
Geographic Information | ||||
Revenues | 576 | 650 | ||
Royalty Revenue | STENDRA/SPEDRA | ||||
Geographic Information | ||||
Revenues | 550 | 649 | 1,729 | 1,819 |
Royalty Revenue | ROW | PANCREAZE | ||||
Geographic Information | ||||
Revenues | 576 | 650 | ||
Royalty Revenue | ROW | STENDRA/SPEDRA | ||||
Geographic Information | ||||
Revenues | 550 | 649 | 1,729 | 1,819 |
Supply Revenue | ||||
Geographic Information | ||||
Revenues | 478 | 2,133 | 3,203 | 8,064 |
Supply Revenue | STENDRA/SPEDRA | ||||
Geographic Information | ||||
Revenues | 478 | 2,133 | 3,203 | 8,064 |
Supply Revenue | U.S. | STENDRA/SPEDRA | ||||
Geographic Information | ||||
Revenues | 1,070 | 1,071 | 4,845 | |
Supply Revenue | ROW | STENDRA/SPEDRA | ||||
Geographic Information | ||||
Revenues | $ 478 | 1,063 | $ 2,132 | 3,219 |
License Revenue | ||||
Geographic Information | ||||
Revenues | 2,500 | 7,500 | ||
License Revenue | Qsymia | ||||
Geographic Information | ||||
Revenues | 2,500 | 7,500 | ||
License Revenue | U.S. | Qsymia | ||||
Geographic Information | ||||
Revenues | 5,000 | |||
License Revenue | ROW | Qsymia | ||||
Geographic Information | ||||
Revenues | $ 2,500 | $ 2,500 |
Revenue and Cost Of Goods Sold
Revenue and Cost Of Goods Sold By Source (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Geographic Information | ||||
Revenues | $ 18,088 | $ 15,193 | $ 44,948 | $ 53,432 |
Cost of goods sold (excluding amortization) | 3,484 | 3,423 | 9,400 | 12,798 |
Amortization of Intangible Assets | 3,638 | 91 | 5,002 | 453 |
Qsymia | ||||
Geographic Information | ||||
Revenues | 9,737 | 12,411 | 30,503 | 43,549 |
Cost of goods sold (excluding amortization) | 953 | 1,428 | 3,648 | 5,311 |
Amortization of Intangible Assets | 91 | 91 | 272 | 453 |
PANCREAZE | ||||
Geographic Information | ||||
Revenues | 7,323 | 9,513 | ||
Cost of goods sold (excluding amortization) | 2,006 | 2,574 | ||
Amortization of Intangible Assets | 3,547 | 4,730 | ||
STENDRA/SPEDRA | ||||
Geographic Information | ||||
Revenues | 1,028 | 2,782 | 4,932 | 9,883 |
Cost of goods sold (excluding amortization) | 525 | 1,995 | 3,178 | 7,487 |
Net Product Revenue | ||||
Geographic Information | ||||
Revenues | 16,484 | 9,911 | 39,366 | 36,049 |
Net Product Revenue | Qsymia | ||||
Geographic Information | ||||
Revenues | 9,737 | 9,911 | 30,503 | 36,049 |
Net Product Revenue | PANCREAZE | ||||
Geographic Information | ||||
Revenues | 6,747 | 8,863 | ||
Royalty Revenue | ||||
Geographic Information | ||||
Revenues | 1,126 | 649 | 2,379 | 1,819 |
Royalty Revenue | PANCREAZE | ||||
Geographic Information | ||||
Revenues | 576 | 650 | ||
Royalty Revenue | STENDRA/SPEDRA | ||||
Geographic Information | ||||
Revenues | 550 | 649 | 1,729 | 1,819 |
Supply Revenue | ||||
Geographic Information | ||||
Revenues | 478 | 2,133 | 3,203 | 8,064 |
Supply Revenue | STENDRA/SPEDRA | ||||
Geographic Information | ||||
Revenues | $ 478 | 2,133 | $ 3,203 | 8,064 |
License Revenue | ||||
Geographic Information | ||||
Revenues | 2,500 | 7,500 | ||
License Revenue | Qsymia | ||||
Geographic Information | ||||
Revenues | $ 2,500 | $ 7,500 |
Share-Based Compensation (Detai
Share-Based Compensation (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
SHARE-BASED COMPENSATION | ||||
Share-based compensation | $ 676 | $ 753 | $ 2,650 | $ 2,221 |
Cost of goods sold | ||||
SHARE-BASED COMPENSATION | ||||
Share-based compensation | 18 | 13 | 48 | 41 |
Selling, general and administrative | ||||
SHARE-BASED COMPENSATION | ||||
Share-based compensation | 581 | 652 | 2,368 | 1,920 |
Research and development | ||||
SHARE-BASED COMPENSATION | ||||
Share-based compensation | 77 | 88 | 234 | 260 |
Inventory | ||||
SHARE-BASED COMPENSATION | ||||
Total share-based compensation cost capitalized as part of cost of inventory | $ 4 | $ 3 | $ 5 | $ 8 |
Cash, Cash Equivalents, And A_3
Cash, Cash Equivalents, And Available-For-Sale Securities (Fair Value of Cash, Cash Equivalents, and Available-For-Sale Securities) (Details) - USD ($) $ in Thousands | 3 Months Ended | |||
Sep. 30, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Dec. 31, 2016 | |
Cash and cash equivalents and available-for-sale securities, Amortized Cost | ||||
Cash and Cash Equivalents, at Carrying Value | $ 58,022 | $ 66,392 | $ 73,151 | $ 84,783 |
Available-for-sale securities including cash and cash equivalents, Amortized Cost Total | 115,517 | 226,943 | ||
Less amounts classified as cash equivalents, Amortized Cost | (58,022) | (66,392) | $ (73,151) | $ (84,783) |
Available-for-sale Debt Securities, Amortized Cost Basis, Total | 57,495 | 160,551 | ||
Available-for-sale securities, Gross Unrealized Gains | 6 | 17 | ||
Available-for-sale securities, Gross Unrealized Losses | (405) | (625) | ||
Available-for-sale Securities, Debt Securities, Current | 57,096 | 159,943 | ||
Cash and cash equivalents and available-for-sale securities, Estimated Fair Value | ||||
Cash and Cash Equivalents, Fair Value Disclosure | 58,022 | 66,392 | ||
Cash and cash equivalents and available for sale securities, Fair Value Disclosure | 115,118 | 226,335 | ||
Less amounts classified as cash equivalents, Estimated Fair Value | (58,022) | (66,392) | ||
Available-for-sale Securities, Debt Securities, Current | $ 57,096 | 159,943 | ||
Maximum original contractual maturities of available for sale securities | 57 months | |||
U.S. Treasury securities | ||||
Cash and cash equivalents and available-for-sale securities, Amortized Cost | ||||
Available-for-sale Debt Securities, Amortized Cost Basis, Total | $ 14,513 | 21,070 | ||
Available-for-sale securities, Gross Unrealized Gains | 1 | |||
Available-for-sale securities, Gross Unrealized Losses | (156) | (139) | ||
Available-for-sale Securities, Debt Securities, Current | 14,357 | 20,932 | ||
Cash and cash equivalents and available-for-sale securities, Estimated Fair Value | ||||
Available-for-sale Securities, Debt Securities, Current | 14,357 | 20,932 | ||
Corporate Debt Securities [Member] | ||||
Cash and cash equivalents and available-for-sale securities, Amortized Cost | ||||
Available-for-sale Debt Securities, Amortized Cost Basis, Total | 42,982 | 139,481 | ||
Available-for-sale securities, Gross Unrealized Gains | 6 | 16 | ||
Available-for-sale securities, Gross Unrealized Losses | (249) | (486) | ||
Available-for-sale Securities, Debt Securities, Current | 42,739 | 139,011 | ||
Cash and cash equivalents and available-for-sale securities, Estimated Fair Value | ||||
Available-for-sale Securities, Debt Securities, Current | 42,739 | 139,011 | ||
Cash and money market funds | ||||
Cash and cash equivalents and available-for-sale securities, Amortized Cost | ||||
Cash and Cash Equivalents, at Carrying Value | 58,022 | 66,392 | ||
Less amounts classified as cash equivalents, Amortized Cost | (58,022) | (66,392) | ||
Available-for-sale securities, Gross Unrealized Losses | 0 | |||
Cash and cash equivalents and available-for-sale securities, Estimated Fair Value | ||||
Cash and Cash Equivalents, Fair Value Disclosure | 58,022 | 66,392 | ||
Less amounts classified as cash equivalents, Estimated Fair Value | $ (58,022) | $ (66,392) |
Cash, Cash Equivalents, And A_4
Cash, Cash Equivalents, And Available-For-Sale Securities (Fair Value Hierarchy for Cash Equivalents and Available-For-Sale Securities) (Details) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Fair value measurements | ||
Cash and Cash Equivalents, Fair Value Disclosure | $ 58,022 | $ 66,392 |
Available-for-sale Securities, Debt Securities, Current | 57,096 | 159,943 |
Cash and cash equivalents and available for sale securities, Fair Value Disclosure | 115,118 | 226,335 |
U.S. Treasury securities | ||
Fair value measurements | ||
Available-for-sale Securities, Debt Securities, Current | 14,357 | 20,932 |
Corporate Debt Securities [Member] | ||
Fair value measurements | ||
Available-for-sale Securities, Debt Securities, Current | 42,739 | 139,011 |
Level 1 | ||
Fair value measurements | ||
Cash and Cash Equivalents, Fair Value Disclosure | 58,022 | 66,392 |
Cash and cash equivalents and available for sale securities, Fair Value Disclosure | 72,379 | 87,324 |
Level 1 | U.S. Treasury securities | ||
Fair value measurements | ||
Available-for-sale Securities, Debt Securities, Current | 14,357 | 20,932 |
Level 1 | Corporate Debt Securities [Member] | ||
Fair value measurements | ||
Available-for-sale Securities, Debt Securities, Current | 0 | 0 |
Level 2 | ||
Fair value measurements | ||
Cash and Cash Equivalents, Fair Value Disclosure | 0 | 0 |
Cash and cash equivalents and available for sale securities, Fair Value Disclosure | 42,739 | 139,011 |
Level 2 | U.S. Treasury securities | ||
Fair value measurements | ||
Available-for-sale Securities, Debt Securities, Current | 0 | 0 |
Level 2 | Corporate Debt Securities [Member] | ||
Fair value measurements | ||
Available-for-sale Securities, Debt Securities, Current | 42,739 | 139,011 |
Level 3 | ||
Fair value measurements | ||
Cash and Cash Equivalents, Fair Value Disclosure | 0 | 0 |
Cash and cash equivalents and available for sale securities, Fair Value Disclosure | 0 | 0 |
Level 3 | U.S. Treasury securities | ||
Fair value measurements | ||
Available-for-sale Securities, Debt Securities, Current | 0 | 0 |
Level 3 | Corporate Debt Securities [Member] | ||
Fair value measurements | ||
Available-for-sale Securities, Debt Securities, Current | $ 0 | $ 0 |
Accounts Receivable (Details)
Accounts Receivable (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2017 | |
Accounts Receivable, Gross, Current | $ 23,798 | $ 12,382 |
Accounts receivable, net | 23,625 | 12,187 |
Qsymia | ||
Accounts Receivable, Gross, Current | 11,514 | 10,400 |
Qsymia | Reserve for cash discount | ||
Qsymia allowance for cash discounts | (173) | (195) |
PANCREAZE | ||
Accounts Receivable, Gross, Current | 11,126 | |
STENDRA/SPEDRA | ||
Accounts Receivable, Gross, Current | $ 1,158 | $ 1,982 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Inventory balances | ||
Raw materials | $ 15,383 | $ 13,663 |
Work in process | 1,815 | 2,264 |
Finished goods | 4,405 | 1,785 |
Total | $ 21,603 | $ 17,712 |
Prepaid Expenses And Other Cu_3
Prepaid Expenses And Other Current Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
OTHER CURRENT ASSETS | ||
Prepaid sales and marketing expenses | $ 1,579 | $ 1,538 |
Taxes receivable | 2,008 | 1,222 |
Prepaid insurance | 149 | 1,124 |
Other prepaid expenses and assets | 4,008 | 3,294 |
Total | $ 7,744 | $ 7,178 |
Intangible And Other NonCurrent
Intangible And Other NonCurrent Assets (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||
Jun. 30, 2018 | Sep. 30, 2014 | Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | |
Accumulated Amortization | $ (7,236) | $ (7,236) | $ (2,235) | ||||
Net intangible assets | 137,709 | 137,709 | |||||
Prepaid Expense Other, Noncurrent | 209 | 209 | 199 | ||||
Other Assets, Noncurrent | 145,154 | 145,154 | 3,249 | ||||
Other Assets, Miscellaneous, Noncurrent | 137,918 | 137,918 | 1,014 | ||||
Amortization of Intangible Assets | 3,638 | $ 91 | 5,002 | $ 453 | |||
Janssen | |||||||
Finite-Lived Patents, Gross | $ 3,100 | ||||||
Patents | Janssen | |||||||
Finite-Lived Intangible Assets, Gross | 3,050 | 3,050 | 3,050 | ||||
Accumulated Amortization | (2,506) | (2,506) | (2,235) | ||||
Net intangible assets | 544 | 544 | $ 815 | ||||
Finite-Lived Intangible Asset, Useful Life | 5 years 6 months | ||||||
License | PANCREAZE | |||||||
Finite-Lived Intangible Assets, Gross | 141,895 | 141,895 | |||||
Accumulated Amortization | (4,730) | (4,730) | |||||
Net intangible assets | $ 137,165 | $ 137,165 | |||||
Finite-Lived Intangible Asset, Useful Life | 10 years |
Intangible Future Expected Amor
Intangible Future Expected Amortization Expenses (Details) $ in Thousands | Sep. 30, 2018USD ($) |
Finite-Lived Intangible Assets, Net [Abstract] | |
2018 (Remainder) | $ 3,639 |
2,019 | 14,552 |
2,020 | 14,280 |
2,021 | 14,190 |
2,022 | 14,190 |
Thereafter | 76,858 |
Net intangible assets | $ 137,709 |
Accrued And Other Liabilities_2
Accrued And Other Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
ACCRUED AND OTHER LIABILITIES | ||
Accrued employee compensation and benefits | $ 2,765 | $ 3,642 |
Reserve for product returns (See Note 2) | 12,995 | 7,854 |
Product-related accruals (see Note 2) | 6,235 | 5,751 |
Accrued interest on debt (see Note 13) | 1,730 | 410 |
Accrued manufacturing costs | 5,679 | 1,238 |
Other accrued liabilities | 2,520 | 2,580 |
Total | $ 31,924 | $ 21,475 |
Deferred Revenue (Details)
Deferred Revenue (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended |
Sep. 30, 2018 | Sep. 30, 2018 | |
SPEDRA | ||
DEFERRED REVENUE | ||
Deferred Revenue, Revenue Recognized | $ 0.3 | $ 0.9 |
License, Commercialization An_2
License, Commercialization And Supply Agreements (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||
Jun. 30, 2018USD ($)$ / sharesshares | Sep. 30, 2017USD ($) | Nov. 30, 2013 | Jul. 31, 2013country | Sep. 30, 2018USD ($) | Sep. 30, 2017USD ($) | Sep. 30, 2018USD ($) | Sep. 30, 2017USD ($) | |
License, Commercialization, and Development Agreements with Third Parties | ||||||||
Revenues | $ 18,088 | $ 15,193 | $ 44,948 | $ 53,432 | ||||
Payments to Acquire Businesses, Gross | $ 135,000 | |||||||
PANCREAZE | ||||||||
License, Commercialization, and Development Agreements with Third Parties | ||||||||
Finite-Lived License Agreements, Gross | $ 141,900 | |||||||
PANCREAZE | Warrants Issued | ||||||||
License, Commercialization, and Development Agreements with Third Parties | ||||||||
Fair Value Assumptions, Expected Term | 7 years | |||||||
Fair Value Assumptions, Expected Volatility Rate | 61.60% | |||||||
Fair Value Assumptions, Risk Free Interest Rate | 2.91% | |||||||
Fair Value Assumptions, Expected Dividend Rate | 0.00% | |||||||
PANCREAZE | Janssen | ||||||||
License, Commercialization, and Development Agreements with Third Parties | ||||||||
Payments to Acquire Businesses, Gross | $ 135,000 | |||||||
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Current Liabilities, Other | 400 | |||||||
Business Combination Recognized Identifiable Assets Acquired And Liabilities Assumed Accruals For Estimated Destruction Of Future Unsalable Inventory | 6,300 | |||||||
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Inventory | $ 2,100 | |||||||
PANCREAZE | Willow Biopharma Member | ||||||||
License, Commercialization, and Development Agreements with Third Parties | ||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | shares | 357,000 | |||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 3.70 | |||||||
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Current Liabilities, Other | $ 1,500 | |||||||
PANCREAZE | Willow Biopharma Member | Warrants Issued | ||||||||
License, Commercialization, and Development Agreements with Third Parties | ||||||||
Business Combination, Consideration Transferred, Equity Interests Issued and Issuable | $ 800 | |||||||
License and commercialization agreement | Menarini Group | ||||||||
License, Commercialization, and Development Agreements with Third Parties | ||||||||
Number of European countries covered under the license agreement | country | 40 | |||||||
License and commercialization agreement | Qsymia | Alvogen | ||||||||
License, Commercialization, and Development Agreements with Third Parties | ||||||||
Revenues | $ 2,500 | |||||||
License and commercialization agreement | PANCREAZE | ||||||||
License, Commercialization, and Development Agreements with Third Parties | ||||||||
Acquired Finite-lived Intangible Assets, Weighted Average Useful Life | 10 years | |||||||
Supply agreement | Avanafil Tablets Member | Sanofi Winthrop | Minimum | ||||||||
License, Commercialization, and Development Agreements with Third Parties | ||||||||
Long-term Purchase Commitment, Period | 5 years | |||||||
Supply agreement | STENDRA/SPEDRA | Metuchen | ||||||||
License, Commercialization, and Development Agreements with Third Parties | ||||||||
Initial term | 5 years | |||||||
Additional period of auto-renewal | 2 years | |||||||
Supply agreement | STENDRA/SPEDRA | Metuchen | Minimum | ||||||||
License, Commercialization, and Development Agreements with Third Parties | ||||||||
Termination notice of license and supply agreement | 2 years |
Long-Term Debt (Schedule of Deb
Long-Term Debt (Schedule of Debt) (Details) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Long-term debt | ||
Net carrying value | $ 300,182 | $ 235,683 |
Less current portion | 5,147 | |
Long-term debt, net of current portion | 300,182 | 230,536 |
Senior Secured Notes Due 2018 | ||
Long-term debt | ||
Senior Secured Notes | 6,187 | |
Debt Instrument, Unamortized Discount (Premium) and Debt Issuance Costs, Net | (7) | |
Net carrying value | 6,180 | |
Convertible Senior Notes Due 2020 | ||
Long-term debt | ||
Senior Secured Notes | 190,000 | 250,000 |
Debt Instrument, Unamortized Discount (Premium) and Debt Issuance Costs, Net | 3,685 | (20,497) |
Net carrying value | 193,685 | $ 229,503 |
Senior Secured Notes Due 2024 member | ||
Long-term debt | ||
Senior Secured Notes | 110,000 | |
Debt Instrument, Unamortized Discount (Premium) and Debt Issuance Costs, Net | (3,503) | |
Net carrying value | $ 106,497 |
Long-Term Debt (Narrative) (Det
Long-Term Debt (Narrative) (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |
Jun. 30, 2018 | Sep. 30, 2018 | Sep. 30, 2018 | Sep. 30, 2017 | |
Long-term debt | ||||
Repayments of Notes Payable | $ 57,187 | $ 21,770 | ||
FDA Approval Qsymia (PMR and CVOT) Member | ||||
Long-term debt | ||||
Contractual Obligation Term | 5 years | |||
Minimum | FDA Approval Qsymia (PMR and CVOT) Member | ||||
Long-term debt | ||||
Contractual Obligation | $ 180,000 | 180,000 | ||
Maximum | FDA Approval Qsymia (PMR and CVOT) Member | ||||
Long-term debt | ||||
Contractual Obligation | $ 220,000 | $ 220,000 | ||
Convertible Senior Notes Due 2020 | ||||
Long-term debt | ||||
Debt Instrument, Interest Rate, Stated Percentage | 4.50% | |||
Extinguishment of Debt, Amount | $ 60,000 | |||
Repayments of Notes Payable | $ 51,000 | |||
Senior Secured Note Athyrium Due 2024 Member | ||||
Long-term debt | ||||
Long-term Debt, Weighted Average Interest Rate, at Point in Time | 11.30% | |||
Senior Secured Note Athyrium Due 2024 Member | Athyrium Capital Management Affiliates Member | ||||
Long-term debt | ||||
Senior Notes | $ 110,000 | |||
Debt Instrument, Interest Rate, Stated Percentage | 10.375% | |||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 330,000 | |||
Debt Instrument, Redemption Price, Percentage of Principal Amount Redeemed | 99.00% | |||
Senior Secured Note Athyrium Due 2024 Member | Warrants Issued | Athyrium Capital Management Affiliates Member | ||||
Long-term debt | ||||
Fair Value Assumptions, Expected Term | 6 years | |||
Fair Value Assumptions, Expected Volatility Rate | 62.70% | |||
Fair Value Assumptions, Risk Free Interest Rate | 2.83% | |||
Fair Value Assumptions, Expected Dividend Rate | 0.00% | |||
Additional Senior Secured Note Athyrium Due 2024 Member | Athyrium Capital Management Affiliates Member | ||||
Long-term debt | ||||
Senior Notes | $ 10,000 | |||
Debt Instrument, Interest Rate, Stated Percentage | 10.375% | |||
Debt Instrument, Term | 12 months |
Long Term Debt Future Amortizat
Long Term Debt Future Amortization (Details) $ in Thousands | Sep. 30, 2018USD ($) |
LONG-TERM DEBT AND COMMITMENTS | |
2018 (remainder) | $ 7,128 |
2,019 | 19,963 |
2,020 | 206,163 |
2,021 | 36,131 |
2,022 | 41,299 |
Thereafter | 55,400 |
Total | $ 366,084 |
Net Income (Loss) Per Share (De
Net Income (Loss) Per Share (Details) - $ / shares shares in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Net income (loss) per share. | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 1,499 | 1,399 | 1,629 | 1,330 |
Convertible Senior Notes Due 2020 | Convertible Common Stock | ||||
Net income (loss) per share. | ||||
Net shares issued | 0 | 0 | 0 | 0 |
Minimum stock price to trigger conversion of debt (in dollars per share) | $ 200 | $ 200 | $ 200 | $ 200 |
Dilutive Securities impact on diluted net income (in dollars per share) | $ 0 | $ 0 | $ 0 | $ 0 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
INCOME TAXES | ||||
Income Tax Expense (Benefit) | $ 36 | $ 8 | $ 52 | $ (3) |
Unrecognized Tax Benefits | $ 144 | $ 144 |
Subsequent Events (Details)
Subsequent Events (Details) - Subsequent event - Athyrium Capital Management Affiliates Member - 4.5% Senior Convertible Notes, Redemption, Prior to May 31, 2019 - USD ($) $ in Millions | Oct. 17, 2018 | Oct. 11, 2018 |
Convertible Notes Athyrium 2020 Member | ||
Debt Instrument, Repurchased Face Amount | $ 7.1 | |
Debt Instrument, Repurchase Amount | $ 8.6 | |
Maximum | First Supplemental Indenture Senior Secured Note Athyrium due 2024 Member | ||
Additional Capacity To Repurchase Principal Amount of Convertibile Notes | $ 20 |