Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2020 | Jul. 31, 2020 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2020 | |
Document Transition Report | false | |
Entity File Number | 001-37372 | |
Entity Registrant Name | Collegium Pharmaceutical, Inc. | |
Entity Incorporation, State or Country Code | VA | |
Entity Tax Identification Number | 03-0416362 | |
Entity Address, Address Line One | 100 Technology Center Drive | |
Entity Address, City or Town | Stoughton | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02072 | |
City Area Code | 781 | |
Local Phone Number | 713-3699 | |
Title of 12(b) Security | Common Stock | |
Trading Symbol | COLL | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 34,525,650 | |
Entity Central Index Key | 0001267565 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Current assets | ||
Cash and cash equivalents | $ 145,678 | $ 170,019 |
Accounts receivable | 81,195 | 72,953 |
Inventory | 18,815 | 9,643 |
Prepaid expenses and other current assets | 5,125 | 3,105 |
Total current assets | 250,813 | 255,720 |
Property and equipment, net | 15,156 | 11,854 |
Operating lease assets | 8,697 | 9,047 |
Intangible asset, net | 369,494 | 29,503 |
Restricted cash | 2,547 | |
Other noncurrent assets | 163 | 178 |
Total assets | 646,870 | 306,302 |
Current liabilities | ||
Accounts payable | 8,182 | 6,247 |
Accrued expenses | 25,111 | 33,480 |
Accrued rebates, returns and discounts | 171,053 | 157,549 |
Current portion of term notes payable | 47,069 | 3,833 |
Current portion of operating lease liabilities | 696 | 656 |
Total current liabilities | 252,111 | 201,765 |
Term notes payable, net of current portion | 133,862 | 7,667 |
Convertible senior notes | 96,046 | |
Operating lease liabilities, net of current portion | 9,084 | 9,438 |
Total liabilities | 491,103 | 218,870 |
Commitments and contingencies (see Note 14) | ||
Shareholders' equity: | ||
Preferred stock, $0.001 par value; authorized shares - 5,000,000 at June 30, 2020 and December 31, 2019; issued and outstanding shares - none at June 30, 2020 and December 31, 2019 | ||
Common stock, $0.001 par value; authorized shares - 100,000,000 at June 30, 2020 and December 31, 2019; issued and outstanding shares - 34,494,302 at June 30, 2020 and 33,678,840 at December 31, 2019 | 34 | 34 |
Additional paid-in capital | 507,124 | 447,297 |
Accumulated deficit | (351,391) | (359,899) |
Total shareholders' equity | 155,767 | 87,432 |
Total liabilities and shareholders' equity | $ 646,870 | $ 306,302 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Jun. 30, 2020 | Dec. 31, 2019 |
CONDENSED CONSOLIDATED BALANCE SHEETS | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, authorized shares | 5,000,000 | 5,000,000 |
Preferred stock, issued shares | 0 | 0 |
Preferred stock, outstanding shares | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, authorized shares | 100,000,000 | 100,000,000 |
Common stock, issued shares | 34,494,302 | 33,678,840 |
Common stock, outstanding shares | 34,494,302 | 33,678,840 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Revenues | ||||
Product revenues, net | $ 78,058 | $ 75,040 | $ 154,569 | $ 149,556 |
Cost of product revenues | ||||
Cost of product revenues (excluding intangible asset amortization) | 12,899 | 44,966 | 40,128 | 90,442 |
Intangible asset amortization | 16,795 | 3,688 | 27,090 | 7,376 |
Total cost of products revenues | 29,694 | 48,654 | 67,218 | 97,818 |
Gross profit | 48,364 | 26,386 | 87,351 | 51,738 |
Operating expenses | ||||
Research and development | 2,493 | 2,459 | 5,159 | 5,451 |
Selling, general and administrative | 29,322 | 28,935 | 60,582 | 61,287 |
Total operating expenses | 31,815 | 31,394 | 65,741 | 66,738 |
Income (loss) from operations | 16,549 | (5,008) | 21,610 | (15,000) |
Interest expense | (8,259) | (236) | (13,082) | (470) |
Interest income | 14 | 532 | 226 | 1,058 |
Income (loss) before income taxes | 8,304 | (4,712) | 8,754 | (14,412) |
Provision for income taxes | 246 | 246 | ||
Net income (loss) | $ 8,058 | $ (4,712) | $ 8,508 | $ (14,412) |
Earnings (loss) per share - basic (in dollars per share) | $ 0.23 | $ (0.14) | $ 0.25 | $ (0.43) |
Weighted-average shares - basic (in shares) | 34,395,266 | 33,397,709 | 34,247,977 | 33,338,243 |
Earnings (loss) per share - diluted (in dollars per share) | $ 0.23 | $ (0.14) | $ 0.24 | $ (0.43) |
Weighted-average shares - diluted (in shares) | 35,091,906 | 33,397,709 | 35,089,740 | 33,338,243 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||||||
Jun. 30, 2020 | Mar. 31, 2020 | Jun. 30, 2019 | Mar. 31, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | Jun. 30, 2020 | Dec. 31, 2019 | Jun. 30, 2019 | |
Operating activities | ||||||||||
Net income (loss) | $ 8,058 | $ 450 | $ (4,712) | $ (9,700) | $ 8,508 | $ (14,412) | ||||
Adjustments to reconcile net income (loss) to net cash used in operating activities: | ||||||||||
Amortization expense | 16,795 | 3,688 | 27,090 | 7,376 | $ 14,752 | |||||
Depreciation expense | 394 | 355 | ||||||||
Stock-based compensation expense | 10,535 | 8,425 | ||||||||
Non-cash lease expense | 36 | 229 | ||||||||
Non-cash interest expense for amortization of debt discount and issuance costs | 3,860 | |||||||||
Changes in operating assets and liabilities: | ||||||||||
Accounts receivable | (8,242) | (3,333) | ||||||||
Inventory | (9,785) | (2,136) | ||||||||
Prepaid expenses and other assets | (2,005) | 509 | ||||||||
Accounts payable | 1,935 | (1,209) | ||||||||
Accrued expenses | (8,645) | (3,285) | ||||||||
Accrued rebates, returns and discounts | 13,504 | 13,481 | ||||||||
Operating lease assets and liabilities | 734 | |||||||||
Other long-term liabilities | (676) | |||||||||
Net cash provided by operating activities | 37,185 | 6,058 | ||||||||
Investing activities | ||||||||||
Purchase of intangible asset | (368,226) | |||||||||
Purchases of property and equipment | (1,662) | (4,198) | ||||||||
Net cash used in investing activities | (369,888) | (4,198) | ||||||||
Financing activities | ||||||||||
Proceeds from issuances of common stock from employee stock purchase plans | 357 | 444 | ||||||||
Proceeds from the exercise of stock options | 6,080 | 299 | ||||||||
Payments made for employee restricted stock tax withholdings | (1,922) | (523) | ||||||||
Proceeds from issuance of term note, net of issuance costs of $2,456 | 192,117 | |||||||||
Proceeds from convertible senior notes, net of issuance costs of $5,473 | 138,277 | |||||||||
Repayment of term notes | (12,500) | |||||||||
Repayment of term loan | (11,500) | |||||||||
Net cash provided by financing activities | 310,909 | 220 | ||||||||
Net (decrease) increase in cash, cash equivalents and restricted cash | (21,794) | 2,080 | ||||||||
Cash, cash equivalents and restricted cash at beginning of period | 170,019 | 146,633 | 170,019 | 146,633 | 146,633 | |||||
Cash, cash equivalents and restricted cash at end of period | 148,225 | 148,713 | 148,225 | 148,713 | 170,019 | |||||
Reconciliation of cash, cash equivalents and restricted cash to the Condensed Consolidated Balance Sheets: | ||||||||||
Cash and cash equivalents | $ 145,678 | $ 170,019 | $ 148,713 | |||||||
Restricted cash | 2,547 | |||||||||
Total cash, cash equivalents and restricted cash | 148,225 | $ 170,019 | $ 148,713 | $ 146,633 | 148,225 | 148,713 | $ 146,633 | $ 148,225 | $ 170,019 | $ 148,713 |
Supplemental disclosure of cash flow information | ||||||||||
Cash paid for interest | 8,259 | 362 | ||||||||
Supplemental disclosure of non-cash activities | ||||||||||
Acquisition of property and equipment in accounts payable and accrued expenses | 1,555 | 512 | ||||||||
Accrued royalties discharged upon closing of asset acquisition | 1,145 | |||||||||
Inventory used in the construction and installation of property and equipment | $ 219 | $ 613 | ||||||||
Receivable from stock option exercises in other current assets | 5 | |||||||||
Operating lease assets assumed | 9,957 | |||||||||
Operating lease liabilities assumed | $ 10,691 |
CONSOLIDATED STATEMENTS OF CA_2
CONSOLIDATED STATEMENTS OF CASH FLOWS (Parenthetical) $ in Thousands | 6 Months Ended |
Jun. 30, 2020USD ($) | |
Term Loan | |
Debt Instrument [Line Items] | |
Issuance costs | $ 2,456 |
Convertible senior notes | |
Debt Instrument [Line Items] | |
Issuance costs | $ 5,473 |
Nature of Business
Nature of Business | 6 Months Ended |
Jun. 30, 2020 | |
Nature of Business | |
Nature of Business | 1. Nature of Business Collegium Pharmaceutical, Inc. (the “Company”) was incorporated in Delaware in April 2002 and then reincorporated in Virginia in July 2014. The Company has its principal operations in Stoughton, Massachusetts. The Company is a specialty pharmaceutical company committed to being the leader in responsible pain management. The Company’s first product, Xtampza ER, is an abuse-deterrent, extended-release, oral formulation of oxycodone. In April 2016, the Food and Drug Administration (the “FDA”) approved the Company’s new drug application (“NDA”) for Xtampza ER for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. In June 2016, the Company announced the commercial launch of Xtampza ER. The Company’s product portfolio also includes Nucynta ER and Nucynta IR (the “Nucynta Products”). In December 2017, the Company entered into a Commercialization Agreement (the “Nucynta Commercialization Agreement”) with Assertio Therapeutics, Inc. (formerly known as Depomed) (“Assertio”), pursuant to which the Company acquired the right to commercialize the Nucynta Products in the United States. The Company began shipping and recognizing product sales on the Nucynta Products on January 9, 2018 and began marketing the Nucynta Products in February 2018. Nucynta ER is an extended-release formulation of tapentadol that is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment, including neuropathic pain associated with diabetic peripheral neuropathy in adults, and for which alternate treatment options are inadequate. Nucynta IR is an immediate-release formulation of tapentadol that is indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults. On February 6, 2020, the Company entered into an Asset Purchase Agreement with Assertio (the “Nucynta Purchase Agreement”), pursuant to which the Company agreed to acquire from Assertio certain assets related to the Nucynta Products (the “Nucynta Acquisition”), including the license from Grünenthal GmbH (“Grünenthal”), for an aggregate purchase price of $375,000 , subject to certain closing and post-closing adjustments as described in the Nucynta Purchase Agreement. On February 13, 2020, the Company closed the Nucynta Acquisition in accordance with the Nucynta Purchase Agreement. Upon closing, the Nucynta Commercialization Agreement was effectively terminated and the Company’s royalty payment obligations to Assertio thereunder ceased. Following the closing, the Company will pay royalties directly to Grünenthal at a rate of In March 2020, the World Health Organization declared the continued spread of a novel coronavirus (“COVID-19”) a pandemic. The pandemic has severely impacted global economic activity, and many countries and many states in the United States have reacted to the outbreak by instituting quarantines, mandating business and school closures and restricting travel. The travel restrictions and “social distancing” recommendations resulting from the spread of COVID-19 have impacted the Company’s sales professionals’ ability to travel to and meet with healthcare providers in person. The Company periodically reviews its accounting estimates in light of changes in circumstances, facts and experience. As of the date of the filing of this Quarterly Report on Form 10-Q, the COVID-19 pandemic and actions taken to contain it have impacted revenue (due to fewer new patients beginning therapy with the Company’s products and adverse impact on the Company’s ability to promote products due to closure or limited operations of many physicians’ offices) and decreased certain operating expenses, including travel, marketing and expenses associated with participation in congresses that have been postponed. The Company believes that the disruptions caused by COVID-19 will continue through 2020 and there remains substantial uncertainty as to when such disruptions will cease (or ease). The Company’s operations are subject to certain risks and uncertainties. The principal risks include inability to successfully commercialize products, changing market conditions for products and development of competing products, changing regulatory environment and reimbursement landscape, litigation related to opioid marketing and distribution practices, manufacture of adequate commercial inventory, inability to secure adequate supplies of active pharmaceutical ingredients, key personnel retention, protection of intellectual property, patent infringement litigation and the availability of additional capital financing on terms acceptable to the Company. The Company believes that its cash and cash equivalents at June 30, 2020, together with expected cash inflows from the commercialization of its products, will enable the Company to fund its operating expenses, debt service and capital expenditure requirements under its current business plan for the foreseeable future. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2020 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying unaudited Condensed Consolidated Financial Statements include the accounts of Collegium Pharmaceutical, Inc. (a Virginia corporation) as well as the accounts of Collegium Securities Corp. (a Massachusetts corporation), incorporated in December 2015, and Collegium NF, LLC (a Delaware limited liability company), organized in December 2017, both wholly owned subsidiaries requiring consolidation. The consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial reporting and as required by Regulation S-X, Rule 10-01. Accordingly, they do not include all of the information and footnotes required by GAAP for complete consolidated financial statements. In the opinion of the Company’s management, the accompanying unaudited Condensed Consolidated Financial Statements contain all adjustments (consisting of items of a normal and recurring nature) necessary to fairly present the financial position of the Company as of June 30, 2020, the results of operations for the three and six months ended June 30, 2020 and 2019, and cash flows for the six months ended June 30, 2020 and 2019. The results of operations for the six months ended June 30, 2020 are not necessarily indicative of the results to be expected for the full year. The preparation of the Condensed Consolidated Financial Statements in accordance with GAAP requires the Company to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues, costs and expenses and the disclosure of contingent assets and liabilities in the Company’s consolidated financial statements and accompanying notes. Estimates in the Company’s consolidated financial statements include revenue recognition, including the estimates of product returns, units prescribed, discounts and allowances related to commercial sales of products, estimates of useful lives with respect to intangible assets, accounting for stock based compensation, contingencies, impairment of intangible assets, and tax valuation reserves. The Company bases estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances. The Company evaluates its estimates and assumptions on an ongoing basis. The Company’s actual results may differ from these estimates under different assumptions or conditions. The consolidated interim 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 fiscal year ended December 31, 2019 (the “Annual Report”). Significant Accounting Policies The Company’s significant accounting policies are described in Note 2, “Summary of Significant Accounting Policies,” in the Company’s Annual Report. During the interim period covered by this Quarterly Report on Form 10-Q, the Company assumed certain material assets and liabilities in connection with consummating the Nucynta Acquisition, in addition to the issuance of convertible notes and term notes that required a review for embedded derivatives. As a result, the Company adopted the following accounting policy: Embedded Derivatives The Company accounts for derivative financial instruments as either equity or liabilities in accordance with Accounting Standards Codification Topic 815, Derivatives and Hedging Other than the aforementioned changes, there have been no material changes in the Company’s significant accounting policies, other than the adoption of accounting pronouncements below, as compared to the significant accounting policies described in the Annual Report. Reclassifications The Company has reclassified certain amounts in its Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2019 to conform to the 2020 presentation. Specifically, the Company disaggregated previously reported cost of product revenues of $48,654 for the three months ended June 30, 2019 into the captions Cost of product revenues (excluding intangible asset amortization) $44,966 and Intangible asset amortization $3,688. In addition, the Company disaggregated previously reported cost of product revenues of $97,818 for the six months ended June 30, 2019 into the captions Cost of product revenues (excluding intangible asset amortization) $90,442 and Intangible asset amortization $7,376. The reclassifications relate to the presentation of the Company’s gross profit and amortization expense and were made to provide the readers of the Company’s consolidated financial statements with additional insight into how the Company and its management view and evaluate its performance and profitability. This reclassification within the consolidated statements of operations for the three and six months ended June 30, 2019 had no impact on previously reported total consolidated revenues or consolidated results of operations. Recently Adopted Accounting Pronouncements New accounting pronouncements are issued periodically by the Financial Accounting Standards Board (“FASB”) and are adopted by the Company as of the specified effective dates. The Company adopted Accounting Standard Updated (“ASU”) 2016-13 , Financial Instruments – Credit Losses (ASC Topic 326): Measurement of Credit Losses on Financial Instruments, w In March 2020, the FASB issued ASU 2020-04, Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting December 31, 2022. Upon the transition of the Company’s contracts and transactions to new reference rates in connection with reference rate reform, the Company will prospectively apply the amendments of ASU 2020-04 and disclose the effect on its consolidated financial statements Recently Issued Accounting Pronouncements Not Yet Adopted In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes |
Revenue from Contracts with Cus
Revenue from Contracts with Customers | 6 Months Ended |
Jun. 30, 2020 | |
Revenue from Contracts with Customers | |
Revenue from Contracts with Customers | 3. Revenue from Contracts with Customers The Company’s revenue to date is from sales of the Company’s products, which are primarily sold to distributors (“customers”), which in turn sell the product to pharmacies for the treatment of patients (“end users”). Revenue Recognition In accordance with Accounting Standards Codification Topic 606, Revenue from Contracts with Customers (“ASC Topic 606”), Performance Obligations The Company determined that performance obligations are satisfied and revenue is recognized when a customer takes control of the Company’s product, which occurs at a point in time. This generally occurs upon delivery of the products to customers, at which point the Company recognizes revenue and records accounts receivable, which represents the Company’s only contract asset. Payment is typically received 30 one Transaction Price and Variable Consideration Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring products or services to a customer (“transaction price”). The transaction price for product sales includes variable consideration related to sales deductions, including (1) rebates and incentives, including managed care rebates, government rebates, co-pay program incentives, and sales incentives and allowances; (2) product returns, including return estimates for both the Xtampza ER and the Nucynta Products; and, (3) trade allowances and chargebacks, including fees for distribution service fees, prompt pay discounts, and chargebacks. The Company will estimate the amount of variable consideration that should be included in the transaction price under the expected value method for all sales deductions other than trade allowances, which are estimated under the most likely amount method. These provisions reflect the expected amount of consideration to which the Company is entitled based on the terms of the contract. In addition, the Company made a policy election to exclude from the measurement of the transaction price all taxes that are assessed by a governmental authority that are imposed on revenue-producing transactions. Provisions for rebates and incentives are based on the estimated amount of rebates and incentives to be claimed on the related sales from the period. As the Company’s rebates and incentives are based on products dispensed to patients, the Company is required to estimate the expected value of claims at the time of product delivery to distributors. Given that distributors sell the product to pharmacies, which in turn dispense the product to patients, claims can be submitted significantly after the related sales are recognized. The Company’s estimates of these claims are based on the historical experience of existing or similar programs, including current contractual and statutory requirements, specific known market events and trends, industry data, and estimated distribution channel inventory levels. Accruals and related reserves required for rebates and incentives are adjusted as new information becomes available, including actual claims. If actual results vary, the Company may need to adjust these estimates, which could have an effect on earnings in the period of the adjustment. Provisions for product returns are based on product-level historical trends, as well as relevant market events and other factors. For Xtampza ER, since the product has only been commercially sold since June 2016, estimates of product returns are based on a combination of historical returns processed to date, taking into consideration the expiration date of the product upon delivery to customers, as well as forecasted customer buying patterns, shipment and prescription trends, channel inventory levels, and other specifically known market events and trends. For the Nucynta Products, estimates of product returns are primarily based on historical trends as the Nucynta Products have been commercially sold for a number of years. Provisions for trade allowances and chargebacks are primarily based on customer-level contractual terms. Accruals and related reserves are adjusted as new information becomes available, which generally consists of actual trade allowances and chargebacks processed relating to sales recognized in the period. The amount of variable consideration that is included in the transaction price may be constrained and is included in net sales only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. In general, performance obligations do not include any estimated amounts of variable consideration that are constrained. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known. The following tables summarize activity in each of the Company’s product revenue provision and allowance categories for the six months ended June 30, 2020 and 2019: Trade Rebates and Product Allowances and Six months ended June 30, 2020 Incentives (1) Returns (2) Chargebacks (3) Balance at December 31, 2019 $ 129,901 $ 27,648 $ 14,020 Provision related to current period sales 162,637 6,703 37,230 Changes in estimate related to prior period sales (171) — 85 Credits/payments made (154,145) (1,520) (36,482) Balance at June 30, 2020 $ 138,222 $ 32,831 $ 14,853 Trade Rebates and Product Allowances and Six months ended June 30, 2019 Incentives (1) Returns (2) Chargebacks (3) Balance at December 31, 2018 $ 129,318 $ 15,465 $ 14,841 Provision related to current period sales 128,509 9,150 31,988 Changes in estimate related to prior period sales (3,017) — — Credits/payments made (119,659) (1,502) (32,673) Balance at June 30, 2019 $ 135,151 $ 23,113 $ 14,156 (1) Provisions for rebates and incentives includes managed care rebates, government rebates and co-pay program incentives. Provisions for rebates and incentives are deducted from gross revenues at the time revenues are recognized and are included in accrued rebates, returns and discounts in the Company’s Consolidated Condensed Balance Sheets. (2) Provisions for product returns are deducted from gross revenues at the time revenues are recognized and are included in accrued rebates, returns and discounts in the Company’s Condensed Consolidated Balance Sheets. (3) Provisions for trade allowances and chargebacks include fees for distribution service fees, prompt pay discounts, and chargebacks. Trade allowances and chargebacks are deducted from gross revenue at the time revenues are recognized and are recorded as a reduction to accounts receivable in the Company’s Condensed Consolidated Balance Sheets. As of June 30, 2020, the Company did not have any transaction price allocated to remaining performance obligations and any costs to obtain contracts with customers, including pre-contract costs and set up costs, were immaterial. Disaggregation of Revenue The Company disaggregates its product revenue, net from contracts with customers, into the categories included in the table below. These categories depict how the nature, timing and uncertainty of revenue and cash flows are affected by economic factors: Three months ended June 30, Six months ended June 30, 2020 2019 2020 2019 Xtampza ER $ 33,557 $ 26,018 $ 65,064 $ 51,152 Nucynta Products (1) 44,501 49,022 89,505 98,404 Total product revenues, net $ 78,058 $ 75,040 $ 154,569 $ 149,556 (1) For the three months ended June 30, 2020, the Company recognized Nucynta IR and Nucynta ER product revenues, net of $29,073 and $15,427, respectively. For the three months ended June 30, 2019, the Company recognized Nucynta IR and Nucynta ER product revenues, net of $29,461 and $19,561, respectively. For the six months ended June 30, 2020, the Company recognized Nucynta IR and Nucynta ER product revenues, net of $57,044 and $32,461, respectively. For the six months ended June 30, 2019, the Company recognized Nucynta IR and Nucynta ER product revenues, net of $59,322 and $39,082, respectively. |
License Agreements
License Agreements | 6 Months Ended |
Jun. 30, 2020 | |
License Agreements | |
License Agreements | 4. License Agreements The Company periodically enters into license agreements to develop and commercialize products. During the three and six months ended June 30, 2020 and 2019, the only products sold by the Company under a license agreement were the Nucynta Products. Prior to February 13, 2020, the Company sold the Nucynta Products pursuant to the rights licensed and acquired under the Nucynta Commercialization Agreement. Effective February 13, 2020, the Company sold the Nucynta Products pursuant to the rights licensed and acquired under the Nucynta Purchase Agreement, including certain intellectual property and manufacturing rights that it did not previously own under the Commercialization Agreement (see Note 8). Nucynta Commercialization Agreement On January 9, 2018 (the “Nucynta Commercialization Closing Date”), the Company consummated the transactions contemplated by the Nucynta Commercialization Agreement, pursuant to which Assertio agreed to grant a sublicense of certain of its intellectual property related to the Nucynta Products for commercialization in the United States. The Company began recording revenues from sales of the Nucynta Products on the Nucynta Commercialization Closing Date and began commercial promotion of the Nucynta Products in February 2018. Pursuant to the Nucynta Commercialization Agreement, the Company paid a one-time, non-refundable license fee of $10,000 to Assertio on the Nucynta Commercialization Closing Date, $6,223 for transferred inventory and $1,987 as reimbursement for prepaid expenses. The Company also assumed the existing liabilities of the Nucynta Products, including $22,660 related to sales of Nucynta Products that occurred prior to the Nucynta Commercialization Closing Date. The Nucynta Commercialization Agreement initially required the Company to pay a guaranteed minimum royalty of $135,000 per year through December 2021, payable in quarterly payments of $33,750, prorated in 2018 for the Nucynta Commercialization Closing Date, as well as a variable royalty based on annual net sales over $233,000. Beginning January 2022 and for each year of the Nucynta Commercialization Agreement term thereafter, the Company was required to pay a variable royalty on annual net sales of the Nucynta Products, but without a guaranteed minimum. Effective August 2018, the Company entered into a Second Amendment to the Nucynta Commercialization Agreement to clarify the mechanism for transferring title of products to be sold by the Company pursuant to the agreement and various related matters. The Second Amendment did not have an impact on the Company’s financial statements. Effective November 2018, the Company entered into the Third Amendment to the Nucynta Commercialization Agreement to adjust the royalty structure and termination clauses. Pursuant to the amended Nucynta Commercialization Agreement, the $135,000 guaranteed minimum annual royalties were eliminated, and the Company was no longer required to secure its royalty payment obligations with a standby letter of credit. Beginning on January 1, 2019 and thereafter, the Company was obligated to make royalty payments to Assertio conditional upon net sales and based on the following royalty structure for the period between January 1, 2019 and December 31, 2021: (i) (ii) (iii) (iv) (v) The Amendment did not modify the royalties payable on sales of the Nucynta Products on and after January 1, 2022, which remained as contemplated by the Nucynta Commercialization Agreement as in effect on January 9, 2018. In addition, prior to January 1, 2022, the Company was obligated to make royalty payments to Assertio, for ultimate payment to Grünenthal, at a rate of 14% of net sales of the Nucynta Products, subject to a guaranteed royalty of $34,000 when net sales were between $180,000 and $243,000. The Amendment further provided that if annual net sales of the Nucynta Products were less than $180,000 in any 12-month period through January 1, 2022, or if they are less than $170,000 in any 12-month period commencing on January 1, 2022, Assertio had the right to terminate the Nucynta Commercialization Agreement without penalty. The Amendment further provides that the Company did not have a right to terminate the Nucynta Commercialization Agreement prior to December 31, 2021. In connection with execution of the Third Amendment to the Nucynta Commercialization Agreement, the Company issued a warrant to Assertio to purchase 1,041,667 shares of common stock of the Company (the “Warrant”) at an exercise price of $19.20 per share. The Warrant will expire in November 2022 and includes customary adjustments for changes in the Company’s capitalization. Nucynta Purchase Agreement On February 6, 2020, the Company entered into the Nucynta Purchase Agreement with Assertio, pursuant to which the Company agreed to acquire from Assertio certain intellectual property and manufacturing rights related to the Nucynta Products for an aggregate purchase price of $375,000, subject to certain closing and post-closing adjustments as described in the Nucynta Purchase Agreement. In connection with the Nucynta Purchase Agreement, the Company also agreed to assume certain regulatory and supply chain contracts and obligations related to Nucynta Products. The Nucynta Purchase Agreement contains customary representations, warranties and covenants, and indemnification provisions subject to specified limitations. After the closing of the Nucynta Purchase Agreement, for the years 2020 and 2021, the Company will pay conditional royalties directly to Grünenthal at a rate of 14% of net sales of the Nucynta Products. This royalty payment obligation will replace the Company’s previous obligation to pay a royalty rate of 14% of net sales of the Nucynta Products to Grünenthal, subject to a guaranteed royalty of $34,000 when net sales are between $180,000 and $243,000. On February 13, 2020, the Company closed the Nucynta Acquisition in accordance with the Nucynta Purchase Agreement. Upon the closing, the Nucynta Commercialization Agreement was terminated, with the exception of certain provisions thereof which survived pursuant to the terms of the Nucynta Purchase Agreement, and the Company’s royalty payment obligations to Assertio thereunder ceased. The assets acquired, liabilities assumed, and equity interests issued by the Company in connection with the Nucynta Commercialization Agreement and Nucynta Purchase Agreement are further described in Note 8. |
Earnings Per Share
Earnings Per Share | 6 Months Ended |
Jun. 30, 2020 | |
Earnings Per Share | |
Earnings Per Share | 5. Earnings Per Share Basic net earnings per share is calculated by dividing the net income (loss) by the weighted average number of shares of common stock outstanding during the period. Diluted earnings per share is computed by dividing the net income (loss) by the weighted average number of shares of common stock, plus potentially dilutive securities outstanding for the period, as determined in accordance with the treasury stock accounting method. Potentially dilutive securities outstanding include stock options, unvested restricted stock units, performance share units, warrants, and shares related to the convertible senior notes, but are only included to the extent that their addition is dilutive. The following table presents the computations of basic and dilutive earnings (loss) per common share: Three months ended June 30, Six months ended June 30, 2020 2019 (1) 2020 2019 (1) Numerator: Net income (loss) $ 8,058 $ (4,712) $ 8,508 $ (14,412) Denominator: Weighted-average shares outstanding - basic 34,395,266 33,397,709 34,247,977 33,338,243 Effect of dilutive securities: Stock options 432,688 — 491,985 — Restricted stock units 212,221 — 262,849 — Performance share units 8,796 — 8,459 — Employee Stock Purchase Program 22,822 31,608 Warrants 20,113 — 46,862 — Weighted average shares outstanding - diluted 35,091,906 33,397,709 35,089,740 33,338,243 Earnings (loss) per share — basic $ 0.23 $ (0.14) $ 0.25 $ (0.43) Earnings (loss) per share — diluted $ 0.23 $ (0.14) $ 0.24 $ (0.43) (1) The Company incurred a net loss for the three and six months ended June 30, 2019, causing inclusion of any potentially dilutive securities to have an anti-dilutive effect, which resulted in basic loss per share and dilutive loss per share being equivalent. The Company has the option to settle the conversion obligation for its convertible senior notes due in 2026 in cash, shares or any combination of the two. Since the Company intends to settle the principal amount of the convertible senior notes in cash, the Company used the treasury stock method for determining the potential dilution in the diluted earnings per share computation. For the three and six months ended June 30, 2020 the Company excluded 4,925,134 shares related to the convertible senior notes because their effect is anti-dilutive. The following table presents dilutive securities excluded from the calculation of diluted earnings per share due to their anti-dilutive effect: Three months ended June 30, Six months ended June 30, 2020 2019 2020 2019 Stock options 2,361,601 4,190,116 2,269,895 4,190,116 Warrants — 1,041,667 — 1,041,667 Restricted stock units 722,388 892,237 648,842 892,237 Performance share units 267,498 99,400 267,498 99,400 Convertible senior notes 4,925,134 — 4,925,134 — |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 6 Months Ended |
Jun. 30, 2020 | |
Fair Value of Financial Instruments | |
Fair Value of Financial Instruments | 6. Fair Value of Financial Instruments Disclosures of fair value information about financial instruments are required for financial instruments with respect to which it is practicable to estimate that value. Fair value measurements and disclosures describe the fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value, as follows: Level 1 inputs: Quoted prices (unadjusted) in active markets for identical assets or liabilities Level 2 inputs: Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly Level 3 inputs: Unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability Transfers are calculated on values as of the transfer date. There were no transfers between Levels 1, 2 and 3 during the six months ended June 30, 2020 and 2019. The following tables present the Company’s financial instruments carried at fair value using the lowest level input applicable to each financial instrument at June 30, 2020 and December 31, 2019: Significant Quoted Prices other Significant in active observable unobservable markets inputs inputs Total (Level 1) (Level 2) (Level 3) June 30, 2020 Money market funds, included in cash equivalents $ 45,065 $ 45,065 $ — $ — December 31, 2019 Money market funds, included in cash equivalents $ 94,841 $ 94,841 $ — $ — The Company’s convertible senior notes fall into the Level 2 category within the fair value level hierarchy. The fair value was determined using broker quotes in a non-active market for valuation. As of June 30, 2020, the convertible senior notes had a fair value of approximately $129,151 and a net carrying value of $96,046. The Company’s term notes fall into the Level 2 category within the fair value level hierarchy and the fair value was determined using quoted prices for similar liabilities in active markets, as well as inputs that are observable for the liability (other than quoted prices), such as interest rates that are observable at commonly quoted intervals. As of June 30, 2020, the carrying amounts of the cash and cash equivalents, accounts receivable, prepaid expenses and other current assets, accounts payable, accrued expenses, accrued rebates, returns and discounts and operating lease liabilities approximated their estimated fair values. |
Inventory
Inventory | 6 Months Ended |
Jun. 30, 2020 | |
Inventory | |
Inventory | 7. Inventory Inventory as of June 30, 2020 and December 31, 2019 consisted of the following: As of June 30, As of December 31, 2020 2019 Raw materials $ 5,153 $ 795 Work in process 2,643 1,427 Finished goods 11,019 7,421 Total inventory $ 18,815 $ 9,643 The aggregate charges related to excess inventory for the three and six months ended June 30, 2020 and 2019 were immaterial. These expenses were recorded as a component of cost of product revenues. During the three and six months ended June 30, 2020, inventory used in the construction and installation of property and equipment was $219 and $613, respectively. During the three and six months ended June 30, 2019, inventory used in the construction and installation of property and equipment was immaterial. |
Intangible Asset
Intangible Asset | 6 Months Ended |
Jun. 30, 2020 | |
Intangible Asset | |
Intangible Asset | 8. Intangible Asset As of June 30, 2020 and December 31, 2019, the Company’s only intangible asset (the “Nucynta Intangible Asset”) is related to the Nucynta Acquisition and Nucynta Commercialization Agreement. The gross carrying amount and accumulated amortization of the Nucynta Intangible Asset were as follows: As of June 30, As of December 31, 2020 2019 Gross carrying amount $ 521,170 $ 154,089 Accumulated amortization (151,676) (124,586) Intangible asset, net $ 369,494 $ 29,503 Nucynta Acquisition In February 2020, the Company entered into the Nucynta Purchase Agreement with Assertio, pursuant to which the Company acquired certain intellectual property and manufacturing rights related to the Nucynta Products, including U.S. commercialization rights, U.S. manufacturing rights, and inventory, for an aggregate purchase price of $375,000, subject to certain closing and post-closing adjustments. The Company also agreed to assume certain regulatory and supply chain contracts, and obligations related to Nucynta Products (see Note 4). In February 2020, the Company entered into a loan agreement (see Note 10) and issued convertible senior notes (see Note 11) to finance a portion of the purchase price paid pursuant to the Nucynta Purchase Agreement. The Company determined that the Nucynta Acquisition, closed in February 2020, should be accounted for as an asset acquisition in accordance with ASC Topic 805-50 because substantially all of the fair value of the gross assets acquired are concentrated in the right to commercialize the Nucynta Products in the U.S. The Company concluded that the fair value estimates of the assets surrendered was more clearly evident than the fair value of the assets received, and therefore followed a cost accumulation model to determine the consideration transferred in the asset acquisition. The consideration transferred in the asset acquisition was measured at cost, including transaction costs, assets transferred by the Company, and royalty obligations discharged by the seller. The table below represents the costs accumulated to acquire the commercial rights for the Nucynta Products based on the terms of the Nucynta Purchase Agreement, as amended: Acquisition consideration: Base purchase price $ 375,000 Cash paid for inventory 6,030 Transaction costs 6,297 Reduction for 2020 cash transferred to Assertio under the prior Nucynta Commercialization Agreement (1) (13,071) Reduction for accrued royalty obligation discharged upon closing (1) (1,145) Total acquisition consideration: $ 373,111 (1) Represents $14,216 total reduction to the base purchase price comprising of $13,071 of cash payments transferred to Assertio under the prior Nucynta Commercialization Agreement as well as a reduction for discharged pre-acquisition accrued royalties based on sales from January 1, 2020 through closing. The Company then allocated the consideration transferred to the individual assets acquired on a relative fair value basis as summarized in the table below: Assets acquired: Nucynta Intangible Asset $ 367,081 Inventory 6,030 Total consideration allocated to assets acquired: $ 373,111 The Company concluded that the consideration allocable to the Nucynta Intangible Asset for the additional intellectual property and manufacturing rights it acquired as part of the Nucynta Acquisition were incremental costs associated with the pre-existing intangible asset from the former Nucynta Commercialization Agreement, as such costs result in probable future economic benefits. Specifically, the additional intellectual property rights acquired in the Nucynta Acquisition enable the Company to eliminate royalty obligations otherwise payable to Assertio under the former Nucynta Commercialization Agreement. Nucynta Commercialization Agreement The Company determined that the Nucynta Commercialization Agreement, which closed in January 2018, should be accounted for as an asset acquisition in accordance with ASC Topic 805-50 , Under the original terms of the Nucynta Commercialization Agreement, the Company was obligated to make guaranteed annual minimum royalty payments of $537,000 to Assertio, which consisted of scheduled payments of $132,000 in 2018, $135,000 in 2019, $135,000 in 2020, and $135,000 in 2021. Due to the nature of the guaranteed minimum royalty payment obligation and the fact that it was required to be settled in cash, the Company determined that the future minimum royalty payments represented a liability that should be recorded at its fair value as of the Nucynta Commercialization Closing Date. The Company calculated the fair value of the future minimum royalty payments to be $482,300 using a discount rate of 5.7%. The discount rate was determined based on a review of observable market data relating to similar liabilities. The Company determined the $54,700 discount should be recognized as interest expense in the Statement of Operations using the effective interest method and over the repayment period from January 9, 2018 through December 2021. Prior to the Third Amendment to the Nucynta Commercialization Agreement in November 2018, the Company recognized interest expense of $19,281 relating to the minimum royalty payments and amortization expense of $107,662 related to the intangible asset. Effective November 8, 2018 (the “Third Amendment Date”), the Company entered into the Third Amendment to the Nucynta Commercialization Agreement, which eliminated the guaranteed minimum royalty payment obligations for years 2019, 2020 and 2021. As a result, the Company remeasured the remaining contractual obligation as of the Third Amendment Date and recorded a reduction of the acquired intangible asset and obligation. As of December 31, 2018, the Company had paid all of the $132,000 of minimum royalty payment obligation owed under the Nucynta Commercialization Agreement for 2018. In connection with the Third Amendment to the Nucynta Commercialization Agreement, the Company issued a warrant to Assertio to purchase 1,041,667 shares of common stock of the Company at an exercise price of $19.20 per share. The Company estimated the fair value of the warrant on the date of issuance to be approximately $8,043 using the Black-Scholes option-pricing model. See Note 12 for further detail regarding the warrant issued to Assertio. A summary of the gross carrying amount, accumulated amortization, and net book value of the Nucynta Intangible Asset from the execution of the Nucynta Commercialization Agreement through period end are as follows: Gross Carrying Value Accumulated Amortization Net Book Value Intangible Asset, net Cost basis as of acquisition date $ 515,627 $ — $ 515,627 Amortization expense from acquisition date through Third Amendment Date — (107,662) (107,662) Adjustment due to the remeasurement of liability as of Third Amendment Date (369,581) — (369,581) Additional costs incurred as of Third Amendment Date (1) 8,043 — 8,043 Amortization expense from Amendment Date through fiscal year end — (2,172) (2,172) Balance as of December 31, 2018 $ 154,089 $ (109,834) $ 44,255 Amortization expense — (14,752) (14,752) Balance as of December 31, 2019 $ 154,089 $ (124,586) $ 29,503 Amortization expense through Nucynta Acquisition — (1,754) (1,754) Additional cost incurred from Nucynta Acquisition 367,081 — 367,081 Amortization expense from Nucynta Acquisition through period end — (25,336) (25,336) Balance as of June 30, 2020: $ 521,170 $ (151,676) $ 369,494 (1) Represents fair value of warrant issued in connection with the Amendment to the Nucynta Commercialization Agreement. Amortization The Company has been amortizing the Nucynta Intangible Asset over its useful life, which is the period over which the asset is expected to contribute directly or indirectly to the future cash flows of the Company. The Company had initially determined that the useful life for the intangible asset was approximately 4.0 years from the closing date of the Nucynta Commercialization Agreement, January 9, 2018 on the basis of the majority of the cash flows expected to be realized for future product sales under the Nucynta Commercialization Agreement. The Nucynta Acquisition significantly impacted the timing and amount of future cash inflows from the sales of the Nucynta Products, and, therefore, the Company considered it to be a triggering event to remeasure the expected useful life of the Nucynta Intangible Asset. The Company determined that the useful life for the Nucynta Intangible Asset was approximately 5.9 years from the Closing Date of the Nucynta Acquisition and accordingly, the intangible asset will be amortized prospectively over its revised useful life. The Company will recognize amortization expense as a component of cost of product revenues in the Condensed Consolidated Statement of Operations on a straight-line basis over its useful life as it approximates the period of economic benefits expected to be realized from future cash inflows from sales of the Nucynta Products. Prior to the Nucynta Acquisition, the Company had recognized $126,340 of amortization expense related to the Nucynta Intangible Asset. As the accumulated cost basis of the Nucynta Intangible Asset was increased with the Nucynta Acquisition, the Company will continue to prospectively amortize the resulting net intangible asset on a straight-line basis over the remaining useful life. The following table presents amortization expense recognized for the three and six months ended June 30, 2020 and 2019: Three months ended June 30, Six months ended June 30, 2020 2019 2020 2019 Nucynta amortization expense included in cost of product revenues $ 16,795 $ 3,688 $ 27,090 $ 7,376 As of June 30, 2020, the remaining amortization period is approximately 5.5 years and is expected to be recognized in the following periods: Years ended December 31, Amortization Expense 2020 $ 33,590 2021 67,181 2022 67,181 2023 67,181 2024 67,181 2025 67,180 Remaining amortization expense: $ 369,494 |
Accrued Expenses
Accrued Expenses | 6 Months Ended |
Jun. 30, 2020 | |
Accrued Expenses | |
Accrued Expenses | 9. Accrued Expenses Accrued expenses as of June 30, 2020 and December 31, 2019 consisted of the following: As of June 30, As of December 31, 2020 2019 Accrued royalties $ 12,531 $ 21,893 Accrued product taxes and fees 3,903 — Accrued bonuses 2,331 4,047 Accrued incentive compensation 1,586 1,650 Accrued interest 1,436 473 Accrued payroll and related benefits 1,284 1,154 Accrued audit and legal 623 308 Accrued sales and marketing 424 775 Accrued other operating costs 993 3,180 Total accrued expenses $ 25,111 $ 33,480 |
Term Notes Payable
Term Notes Payable | 6 Months Ended |
Jun. 30, 2020 | |
Term Notes Payable | |
Term Notes Payable | 10. Term Notes Payable Pharmakon Term Notes On February 6, 2020, in connection with the execution of the Nucynta Purchase Agreement, the Company, together with its subsidiary, Collegium Securities Corporation, entered into a Loan Agreement (the “Loan Agreement”) with BioPharma Credit PLC, as collateral agent and lender, and BioPharma Credit Investments V (Master) LP, as lender (collectively “Pharmakon”). The Loan Agreement provides for a $200,000 secured term loan (the “term notes”), the proceeds of which were used to finance a portion of the purchase price paid pursuant to the Nucynta Purchase Agreement. O n February 13, 2020 , the Company received the net proceeds. The term notes bear interest at a rate based upon the three-month LIBOR rate, subject to a LIBOR floor of 2.0%, plus a margin of 7.5% per annum, payable quarterly in arrears. The Company is required to repay the term notes by making equal quarterly payments of principal beginning in the first quarter immediately following the third month anniversary of the Closing Date. The term notes will mature on the calendar quarter end immediately following the 48-month anniversary of the Closing Date and is guaranteed by the Company’s material domestic subsidiaries and also secured by substantially all of the Company’s material assets. On the Closing Date, the Company paid to Pharmakon a facility fee equal to 2.50% of the aggregate principal amount of the term notes, or $5,000, in addition to $427 of other expenses incurred by Pharmakon and reimbursed by the Company (together, the “discount”). Net proceeds of $194,573 were transferred to Assertio by the Company as agent in partial satisfaction of the Nucynta Purchase Agreement. In addition, the Company capitalized $2,456 of term notes issuance costs, related to legal and advisory fees. Except with respect to certain prepayments made with the proceeds from new equity issuances as described below, the Loan Agreement permits voluntary prepayment at any time, subject to a prepayment premium. The prepayment premium is equal to 3.00% of the principal amount being prepaid prior to the second-year anniversary of the Closing Date, 2.00% of the principal amount being prepaid on or after the second-year anniversary, but on or prior to the third-year anniversary, of the Closing Date, and 1.00% of the principal amount being prepaid on or after the third-year anniversary of the Closing Date, but prior to the fourth-year anniversary of the Closing Date. The Loan Agreement also includes a make-whole premium if there is a voluntary prepayment, a prepayment due to a change in control or acceleration following an Event of Default on or prior to the second-year anniversary of the Closing Date in an amount equal to foregone interest from the date of prepayment through the second-year anniversary of the Closing Date. A change of control triggers a mandatory prepayment of the term notes. The Loan Agreement also permits single voluntary prepayments of the Loan Agreement of less than or equal to $50,000 made solely from the proceeds of an equity issuance by the Company. If equity prepayment occurs prior to the second-year anniversary of the Closing Date, a prepayment premium of 5.00% would apply, with no make-whole premium. The Loan Agreement contains certain covenants and obligations of the parties, including, without limitation, covenants that require the Company to maintain $200,000 in annual net sales and covenants that limit the Company’s ability to incur additional indebtedness or liens, make acquisitions or other investments or dispose of assets outside the ordinary course of business, restrictions which limit the Company’s ability pay dividends and restrictions of net assets of subsidiaries. The Loan Agreement also contains customary events of default, including payment defaults, breaches of covenants, change of control and a material adverse change default. Failure to comply with these covenants would constitute an event of default under the Loan Agreement, notwithstanding the Company’s ability to meet its debt service obligations. The Loan Agreement also includes various customary remedies for Pharmakon following an event of default, including the acceleration of repayment of outstanding amounts under the Loan Agreement and execution upon the collateral securing obligations under the Loan Agreement. Under certain circumstances, a default interest rate will apply on outstanding obligations during the occurrence and continuance of an event of default. As of June 30, 2020, the Company was in compliance with all of its covenants. During the three and six months ended June 30, 2020, the Company recognized interest expense of $5,664 and $8,650 , respectively, related to the term notes. As of June 30, 2020, scheduled principal repayments under the term notes are as follows: Years ended December 31, Principal Payments 2020 $ 25,000 2021 50,000 2022 37,500 2023 50,000 2024 25,000 Total before unamortized discount and issuance costs $ 187,500 Less: unamortized discount and issuance costs (6,569) Total term notes $ 180,931 Silicon Valley Bank Term Loan Facility From August 2012 until January 2020, the Company maintained a term loan facility with Silicon Valley Bank (“SVB”), which was amended in connection with, and as a condition to, consummation of the transactions contemplated by the Nucynta Commercialization Agreement. Under the amended term loan (“Consent and Amendment”), the Company had a term loan facility in an amount of $11,500, which replaced the Company’s previously existing term loan facility. The proceeds of the Consent and Amendment were used to finance certain payment obligations under the Nucynta Commercialization Agreement and to repay the balance of the previously existing term loan. The Consent and Amendment bore interest at a rate per annum of 0.75% above the prime rate (as defined in the Consent and Amendment). The Company was eligible to repay the Consent and Amendment in equal consecutive monthly installments of principal plus monthly payments of accrued interest, commencing in January 2020. In January 2020, the Company prepaid the outstanding principal and accrued interest on the Consent and Amendment along with the required prepayment fees. The loss on extinguishment of the term loan was immaterial and was recorded as a component of interest expense. |
Convertible Senior Notes
Convertible Senior Notes | 6 Months Ended |
Jun. 30, 2020 | |
Convertible Senior Notes | |
Convertible Senior Notes | 11. Convertible Senior Notes On February 13, 2020, the Company issued 2.625% convertible senior notes due in 2026 (the “convertible notes”) in the aggregate principal amount of $143,750, in a public offering registered under the Securities Act of 1933, as amended. The convertible notes were issued in connection with funding the Nucynta Acquisition, and the proceeds of the convertible notes were used to finance a portion of the purchase price payable pursuant to the Nucynta Purchase Agreement. Some of the Company’s existing investors participated in the convertible notes offering. The Company may, at its option, settle the convertible notes in cash, shares of the Company’s common stock or a combination of cash and shares of the Company’s common stock. Accordingly, the Company separately accounted for the liability component (the “Liability Component”) and the embedded derivative conversion option (the “Equity Component”) of the convertible notes by allocating the proceeds between the Liability Component and the Equity Component. In connection with the issuance of the convertible notes, the Company incurred approximately $5,473 of debt issuance costs, which primarily consisted of underwriting, legal and other professional fees, and allocated these costs between the Liability Component and the Equity Component based on the allocation of the proceeds. Of the total debt issuance costs, $1,773 was allocated to the Equity Component and recorded as a reduction to additional paid-in capital and $3,700 was allocated to the Liability Component and recorded as a debt discount of the convertible notes. The portion allocated to the Liability Component is amortized to interest expense using the effective interest method over six years. The convertible notes are the Company’s senior unsecured obligations and bear interest at a rate of 2.625% per year payable semi-annually in arrears on February 15 and August 15 of each year, beginning on August 15, 2020. Before August 15, 2025, noteholders will have the right to convert their notes only upon the occurrence of certain events. From and after August 15, 2025, noteholders may convert their notes at any time at their election until the close of business on the scheduled trading day immediately before the maturity date. The Company will settle conversions by paying or delivering, as applicable, cash, shares of the Company’s common stock or a combination of cash and shares of the Company’s common stock, at the Company’s election. The notes will mature on February 15, 2026, unless earlier repurchased, redeemed or converted. The initial conversion rate is 34.2618 shares of common stock per $1 principal amount of notes, which represents an initial conversion price of approximately $29.19 per share of common stock. The conversion rate and conversion price are subject to adjustment upon the occurrence of certain events. Holders of the convertible notes may convert all or any portion of their convertible notes, in multiples of $1 principal amount, at their option only under the following circumstances: (1) during any calendar quarter commencing after the calendar quarter ending on March 31, 2020, if the last reported sale price per share of the Company’s common stock exceeds 130% of the conversion price for at least 20 trading days during the 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter; (2) during the five consecutive business days immediately after any 10 consecutive trading day period (such 10 consecutive trading day period, the “measurement period”) in which the “trading price” per $1 principal amount of the Notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price per share of the Company’s common stock on such trading day and the conversion rate on such trading day; (3) upon the occurrence of certain corporate events or distributions on the Company’s common stock; (4) if the Company calls the convertible notes for redemption; or (5) at any time from, and including, August 15, 2025 until the close of business on the scheduled trading day immediately before the maturity date. As of June 30, 2020, none of the above circumstances had occurred and as such, the convertible notes could not have been converted. The Company may not redeem the convertible notes prior to February 15, 2023. On or after February 15, 2023, the Company may redeem the convertible notes, in whole and not in part, at a cash redemption price equal to the principal amount of the Notes to be redeemed, plus accrued and unpaid interest, if any, only if the last reported sale price per share of the Company’s common stock exceeds 130% of the conversion price on: (1) each of at least 20 trading days, whether or not consecutive, during the 30 consecutive trading days ending on, and including, the trading day immediately before the date the Company sends the related redemption notice; and (2) the trading day immediately before the date the Company sends such notice. Calling any convertible note for redemption will constitute a make-whole fundamental change with respect to that convertible note, in which case the conversion rate applicable to the conversion of that convertible note, if it is converted in connection with the redemption, will be increased in certain circumstances for a specified period of time. The convertible notes have customary default provisions, including (i) a default in the payment when due (whether at maturity, upon redemption or repurchase upon fundamental change or otherwise) of the principal of, or the redemption price or fundamental change repurchase price for, any note; (ii) a default for 30 days in the payment when due of interest on any note; (iii) a default in the Company’s obligation to convert a note in accordance with the indenture; (iv) a default with respect to the Company’s obligations under the indenture related to consolidations, mergers and asset sales; (v) certain payment or other defaults by the Company or certain subsidiaries with respect to mortgages, agreements or other instruments for indebtedness for money borrowed of at least $20,000 ; and (vi) certain events of bankruptcy, insolvency and reorganization with respect to the Company or any of its significant subsidiaries. The initial carrying amount of the Liability Component of $97,200 was calculated by measuring the fair value of a similar liability that does not have an associated convertible feature. The allocation was performed in a manner that reflected the Company’s non-convertible borrowing rate for similar debt. The Equity Component of the Notes of $46,550 was recognized as a debt discount. The excess of the principal amount of the Liability Component over its carrying amount is amortized to interest expense using the effective interest method over six years. The Equity Component, which is included in the additional paid in capital portion of stockholders’ equity on the Company’s consolidated balance sheet, is not remeasured as long as it continues to meet the conditions for equity classification. As of June 30, 2020, the convertible notes outstanding consisted of the following: Liability component: Principal $ 143,750 Less: unamortized debt discount and issuance costs (47,704) Net carrying amount $ 96,046 Equity component, net of issuance costs of $1,773 $ 44,777 The Company determined the expected life of the convertible notes was equal to its six-year term. The effective interest rate on the Liability Component of the convertible notes was 10.27%. As of June 30, 2020, the “if-converted value” did not exceed the remaining principal amount of the convertible notes. The fair value of the convertible notes was determined based on data points other than quoted prices that are observable, either directly or indirectly, and has been classified as Level 2 within the fair value hierarchy. The fair value of the convertible notes, which differs from their carrying value, is influenced by market interest rates, the Company’s stock price and stock price volatility. The following table presents the total interest expense recognized related to the convertible notes during the three and six months ended June 30, 2020: Three months ended June 30, Six months ended June 30, 2020 2020 Contractual interest expense $ 933 $ 1,436 Amortization of debt discount 1,540 2,359 Amortization of debt issuance costs 122 188 Total interest expense $ 2,595 $ 3,983 As of June 30, 2020, the future minimum payments on the convertible notes were as follows: Years ended December 31, Future Minimum Payments 2020 $ 1,908 2021 3,773 2022 3,773 2023 3,773 2024 3,773 Thereafter 149,412 Total minimum payments $ 166,412 Less: interest (22,662) Less: unamortized debt discount and issuance costs (47,704) Convertible senior notes $ 96,046 |
Equity
Equity | 6 Months Ended |
Jun. 30, 2020 | |
Equity | |
Equity | 12. Equity The changes in shareholders’ equity for six months ended June 30, 2020 were as follows: Additional Total Common Stock Paid- In Accumulated Shareholders’ Shares Amount Capital Deficit Equity (Deficit) Balance, December 31, 2019 33,678,840 $ 34 $ 447,297 $ (359,899) $ 87,432 Exercise of common stock options 455,573 — 4,454 — 4,454 Issuance for employee stock purchase plan 39,411 — 357 — 357 Vesting of restricted stock units ("RSUs") 195,280 — — — — Shares withheld for employee taxes upon vesting of RSUs (63,064) — (1,358) — (1,358) Stock-based compensation — — 4,951 — 4,951 Equity component of 2020 Convertible Notes, net of issuance costs of $1,773 — — 44,777 — 44,777 Net income — — — 450 450 Balance, March 31, 2020 34,306,040 $ 34 $ 500,478 $ (359,449) $ 141,063 Exercise of common stock options 131,562 — 1,626 — 1,626 Vesting of RSUs 83,461 — — — — Shares withheld for employee taxes upon vesting of RSUs (26,761) — (564) — (564) Stock-based compensation — — 5,584 — 5,584 Net income — — — 8,058 8,058 Balance, June 30, 2020 34,494,302 $ 34 $ 507,124 $ (351,391) $ 155,767 The changes in shareholders’ equity for six months ended June 30, 2019 were as follows: Additional Total Common Stock Paid- In Accumulated Shareholders’ Shares Amount Capital Deficit Equity (Deficit) Balance, December 31, 2018 33,265,629 $ 33 $ 428,729 $ (337,177) $ 91,585 Exercise of common stock options 18,693 — 246 — 246 Issuance for employee stock purchase plan 32,826 — 444 — 444 Vesting of RSUs 101,483 — — — — Shares withheld for employee taxes upon vesting of RSUs (33,503) — (488) — (488) Stock-based compensation — — 4,263 — 4,263 Net loss — — — (9,700) (9,700) Balance, March 31, 2019 33,385,128 $ 33 $ 433,194 $ (346,877) $ 86,350 Exercise of common stock options 8,218 — 58 — 58 Vesting of RSUs 26,304 — — — — Shares withheld for employee taxes upon vesting of RSUs (3,097) — (35) — (35) Stock-based compensation — — 4,162 — 4,162 Net loss — — — (4,712) (4,712) Balance, June 30, 2019 33,416,553 $ 33 $ 437,379 $ (351,589) $ 85,823 Warrants As of June 30, 2020, the warrant issued to Assertio in November 2018 was the Company’s only outstanding warrant. In connection with the Third Amendment to the Nucynta Commercialization Agreement, the Company issued a warrant to Assertio to purchase 1,041,667 shares of common stock of the Company at an exercise price of $19.20 per share. The terms of the warrant are fixed, with the exception of customary adjustments for changes in the Company’s capitalization. The warrant may only be settled with the issuance of shares of common stock upon exercise and will expire in November 2022. The Company has recorded the relative fair value of the warrant as a component of equity interest issued by the Company as consideration transferred in the cost accumulation model for the asset acquisition. The Company estimated the fair value of the warrant on the date of issuance to be approximately $8,043 using the Black-Scholes option-pricing model. The Company concluded that the warrant met the definition of an equity instrument and was recorded as a component of additional paid-in capital in the Company’s Condensed Consolidated Balance Sheet as of the issuance date. |
Stock-based Compensation
Stock-based Compensation | 6 Months Ended |
Jun. 30, 2020 | |
Stock-based Compensation | |
Stock-based Compensation | 13. Stock-based Compensation A summary of the Company’s stock-based compensation expense included in the Condensed Consolidated Statements of Operations are as follows: Three months ended June 30, Six months ended June 30, 2020 2019 2020 2019 Research and development expenses $ 984 $ 514 $ 1,754 $ 1,081 Selling, general and administrative expenses 4,600 3,648 8,781 7,344 Total stock-based compensation expense $ 5,584 $ 4,162 $ 10,535 $ 8,425 At June 30, 2020, there was approximately $44,898 of unrecognized compensation expense related to unvested options, restricted stock units and performance stock units, which is expected to be recognized as expense over a weighted average period of approximately 2.8 years. Performance Share Units, Restricted Stock Units and Stock Options In May 2015, the Company adopted the Amended and Restated 2014 Stock Incentive Plan (the “Plan”), under which an aggregate of 2,700,000 shares of common stock were authorized for issuance to employees, officers, directors, consultants and advisors of the Company, plus an annual increase on the first day of each fiscal year until the expiration of the Plan equal to 4% of the total number of outstanding shares of common stock on December 31 st st one Performance Share Units The Company periodically grants performance share units (“PSUs”) to certain members of the Company's senior management team. PSUs vest subject to the satisfaction of annual and cumulative performance and/or market conditions established by the Compensation Committee. In January 2019, the Company granted PSUs with performance conditions related to 2019, 2020, 2021 and three-year cumulative revenue goals for Xtampza ER. The PSUs will vest following a three-year performance period, subject to the satisfaction of the performance criteria and the executive’s continued employment through the performance period. PSUs may vest in a range between 0% and 200%, based on the satisfaction of performance criteria, and no shares will be issued if the minimum applicable performance metric is not achieved. The Company recognizes compensation expense ratably over the required service period based on its estimate of the number of shares that will vest based upon the probability of achieving the performance metrics. If there is a change in the estimate of the number of shares that are likely to vest, the Company will cumulatively adjust compensation expense in the period that the change in estimate is made. In February 2020, the Company additionally granted PSUs with performance criteria related to the relative ranking of the total stockholder return (“TSR”) of the Company’s common stock in 2020, 2021, 2022 and the cumulative three-year performance period return relative to the TSR of certain peer companies within the S&P Pharmaceutical Select Industry Index. TSR will be measured based on the 30-day average stock price on the first day of each period compared to the 30-day average stock price on the last day of each period. The 2020, 2021, and 2022 PSUs will vest annually, subject to the satisfaction of the performance criteria and the executive’s continued employment through the performance period. The cumulative PSUs will vest following the three-year performance period, subject to the satisfaction of the performance criteria and the executive’s continued employment through the performance period. PSUs may vest in a range between 0% and 200%, based on the satisfaction of performance, and no shares will be issued if the minimum applicable performance metric is not achieved. As these PSUs vest based on the achievement of market conditions, the grant date fair values were determined using a Monte-Carlo valuation model. The Monte-Carlo valuation model considered a variety of potential future share prices for the Company as well as its peer companies in the selected market index. The weighted-average grant date fair value of 2020 PSUs granted with market-based vesting conditions was $28.81 based on the valuation model. A summary of the Company’s PSUs activity for the six months ended June 30, 2020 and related information is as follows: Weighted-Average Shares Grant Date Fair Value Outstanding at December 31, 2019 99,400 $ 15.90 Granted 187,978 28.49 Vested — — Forfeited — — Performance adjustment (4,155) 15.90 Outstanding at June 30, 2020 283,223 $ 24.26 The number of PSUs awarded represents the target number of shares of common stock that may be earned; however, the actual number of shares earned may vary based on the satisfaction of performance criteria. The weighted-average grant date fair value of PSUs granted for the six months ended June 30, 2020 and 2019 was $28.49 and $15.90, respectively. For the three months ended June 30, 2020 and 2019, the stock-based compensation expense for PSUs was $729 and $27, respectively. For the six months ended June 30, 2020 and 2019, the stock-based compensation expense for PSUs was $1,126 and $42, respectively. As of June 30, 2020, the unrecognized compensation cost related to performance share units was $4,343 and is expected to be recognized as expense over approximately 2.2 years. Restricted Stock Units A summary of the Company’s restricted stock units activity for the six months ended June 30, 2020 and related information is as follows: Weighted-Average Shares Grant Date Fair Value Outstanding at December 31, 2019 849,679 $ 17.10 Granted 762,607 21.37 Vested (278,741) 17.97 Forfeited (16,025) 18.87 Outstanding at June 30, 2020 1,317,520 $ 19.37 The weighted-average grant date fair value of RSUs granted for the six months ended June 30, 2020 and 2019 was $21.37 and $15.78, respectively. The total fair value of RSUs vested (measured on the date of vesting) for the six months ended June 30, 2020 and 2019 was $5,945 and $1,787, respectively. As of June 30, 2020, the unrecognized compensation cost related to RSUs was $21,688 and is expected to be recognized as expense over approximately 2.9 years. The fair value of RSUs vested during the year ended June 30, 2020 was $5,008. Stock Options A summary of the Company’s stock option activity for the six months ended June 30, 2020 and related information is as follows: Weighted- Weighted- Average Average Remaining Aggregate Exercise Price Contractual Intrinsic Shares per Share Term (in years) Value Outstanding at December 31, 2019 3,955,887 $ 16.00 7.5 $ 21,257 Granted 701,249 21.39 Exercised (587,135) 10.36 Cancelled (98,551) 20.69 Outstanding at June 30, 2020 3,971,450 $ 17.67 7.7 $ 7,866 Exercisable at June 30, 2020 2,123,646 $ 16.95 6.7 $ 5,058 The weighted-average grant date fair value of stock options granted for the six months ended June 30, 2020 and 2019 was $12.83 and $9.36, respectively. The total intrinsic value of stock options exercised for the six months ended June 30, 2020 and 2019, was $7,093 and $123, respectively. As of June 30, 2020, the unrecognized compensation cost related to outstanding options was $18,867 and is expected to be recognized as expense over approximately 2.7 years. The fair value of each stock option is estimated on the grant date using the Black-Scholes option-pricing model using the following assumptions: Six months ended June 30, 2020 2019 Risk-free interest rate 1.3 % 2.6 % Volatility 66.1 % 63.3 % Expected term (years) 6.1 6.1 Expected dividend yield — % — % Employee Stock Purchase Plan The Company’s 2015 Employee Stock Purchase Plan allows employees to purchase shares of the Company’s common stock. The purchase price is equal to 85% of the lower of the closing price of the Company’s common stock on (1) the first day of the purchase period or (2) the last day of the purchase period. During the six months ended June 30, 2020, 39,411 shares of common stock were purchased for total proceeds of $357. During the six months ended June 30, 2019, 32,826 shares of common stock were purchased for total proceeds of $444. The expense for the three months ended June 30, 2020 and 2019 was $92 and $73, respectively. The expense for the six months ended June 30, 2020 and 2019 was $171 and $173, respectively. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2020 | |
Commitments and Contingencies | |
Commitments and Contingencies | 14. Commitments and Contingencies Legal Proceedings From time to time, the Company may face legal claims or actions in the normal course of business. Except as disclosed below, the Company is not currently a party to any litigation and, accordingly, does not have any amounts recorded for any litigation related matters. Xtampza ER Litigation The Company filed the NDA for Xtampza ER as a 505(b)(2) application, which allows the Company to reference data from an approved drug listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), in this case Oxycontin. The 505(b)(2) process requires that the Company certify to the FDA and notify Purdue Pharma, L.P (“Purdue”), as the holder of the NDA and any other Orange Book-listed patent owners, that the Company does not infringe any of the patents listed for Oxycontin in the Orange Book, or that the patents are invalid. The Company made such certification and provided such notice on February 11, 2015 and such certification documented why Xtampza ER does not infringe any of the 11 Orange Book-listed patents for Oxycontin, five of which have been invalidated in court proceedings. Under the Hatch-Waxman Act of 1984, Purdue had the option to sue the Company for infringement and receive a stay of up to 30 months before the FDA could issue a final approval for Xtampza ER, unless the stay was earlier terminated. Purdue exercised its option and elected to sue the Company for infringement in the District of Delaware on March 24, 2015 asserting infringement of three of Purdue’s Orange Book-listed patents (Patent Nos. 7,674,799, 7,674,800, and 7,683,072) and a non-Orange Book-listed patent (Patent No. 8,652,497), and accordingly, received a 30-month stay of FDA approval. The Delaware court transferred the case to the District of Massachusetts. After the Company filed a partial motion for judgment on the pleadings relating to the Orange Book-listed patents, the District Court of Massachusetts ordered judgment in the Company’s favor on those three patents, and dismissed the claims asserting infringement of those patents with prejudice. Upon dismissal of those claims, the 30-month stay of FDA approval was lifted. As a result, the Company was able to obtain final approval for Xtampza ER and launch the product commercially. In November 2015, Purdue filed a follow-on suit asserting infringement of another patent, Patent No. 9,073,933, which was late-listed in the Orange Book and therefore could not trigger any stay of FDA approval. In June 2016, Purdue filed another follow-on suit asserting infringement of another non-Orange Book listed patent, Patent No. 9,155,717. In April 2017, Purdue filed another follow-on suit asserting infringement of another patent, Patent No. 9,522,919, which was late-listed in the Orange Book and therefore could not trigger any stay of FDA approval. Then, in September 2017, Purdue filed another follow-on suit asserting infringement of another non-Orange Book listed patent, Patent No. 9,693,961. On March 13, 2018, the Company filed a Petition for Post-Grant Review (“PGR”) of the ʼ961 patent with the Patent Trial and Appeal Board (“PTAB”). The PGR argues that the ʼ961 patent is invalid for lack of a written description, for lack of enablement, for indefiniteness, and as being anticipated by prior art. Purdue filed its Patent Owner Preliminary Response on July 10, 2018. The PTAB entered an order to institute post-grant review of all claims of the ’961 patent on October 4, 2018, upon a finding that it is more likely than not that the claims of the ʼ961 patent are unpatentable. Purdue filed its Patent Owner Response on January 30, 2019. The Company filed its reply on April 12, 2019, and Purdue filed a sur-reply on May 10, 2019. The PTAB held oral argument on the proceedings on July 10, 2019 and was scheduled to issue a decision on the patentability of the ʼ961 patent by no later than October 4, 2019. On September 15, 2019, Purdue commenced a voluntary case under Chapter 11 of Title 11 of the United States Bankruptcy Code in the United States Bankruptcy Court for the Southern District of New York. On September 24, 2019, Purdue gave the PTAB notice of its bankruptcy filing and sought the imposition of an automatic stay of the PGR proceedings. On October 2, 2019, the PTAB extended the one-year period for issuing its decision by up to six months. The PTAB has held several status conferences but has not issued a Final Written Decision. In October 2017, and in response to the filing of the Company’s Supplemental NDA (“sNDA”) seeking to update the drug abuse and dependence section of the Xtampza ER label, Purdue filed another suit asserting infringement of the ʼ933 and ʼ919 patents. The Company filed a motion to dismiss that action, and the Court granted its motion on January 16, 2018. The current suits have been consolidated by the District of Massachusetts, where Purdue asserted infringement of five patents: the ʼ497 patent, the ʼ933 patent, the ʼ717 patent, the ʼ919 patent, and the ʼ961 patent. The Court issued an order on September 28, 2018 in which it granted in part a motion for summary judgment filed by the Company, and in which the Court ruled that the ʼ497 and ʼ717 patents are not infringed by the Company. As a result, only the ʼ933, the ʼ919, and the ʼ961 patents remain in dispute. On October 16, 2018, the Company filed a motion to stay proceedings in the district court on the ‘961 patent pending the PGR. None of these suits are associated with any 30-month stay of FDA approval for Xtampza ER. Purdue has made a demand for monetary relief but has not quantified its alleged damages. Purdue has also requested a judgment of infringement, an adjustment of the effective date of FDA approval, and an injunction on the sale of the Company’s products accused of infringement. The Company has denied all claims and seeks a judgment that the patents are invalid and/or not infringed by the Company; the Company is also seeking a judgment that the case is exceptional, with an award to the Company of its attorneys’ fees for defending the case. A claim construction hearing was held on June 1, 2017. On November 21, 2017, the Court issued its claim construction ruling, construing certain claims of the ʼ933, ʼ497, and ʼ717 patents. No trial date has been scheduled. On September 18, 2019, Purdue gave the Court notice of its bankruptcy filing and sought the imposition of an automatic stay of the proceedings. On September 20, 2019, the matter was stayed pending further order of the Court. On July 2, 2020, the Company received notice of a motion by Purdue in the Bankruptcy Court for an order to lift the automatic stay on the proceedings in the District of Massachusetts to allow the proceedings to resume. On July 20, 2020, the Company filed a response and a motion in the Bankruptcy Court seeking an order from the Bankruptcy Court that if the automatic stay is lifted as to the Boston District Court proceedings, then the automatic stay should also be lifted as to the PGR on the ‘961 patent in the PTAB. A hearing on the motions in the bankruptcy court is scheduled for August 26, 2020. Once the stay is lifted, the Company plans to defend this case vigorously. At this stage, the Company is unable to evaluate the likelihood of an unfavorable outcome or estimate the amount or range of potential loss, if any. Nucynta Litigation On February 7, 2018, Purdue filed a patent infringement suit against the Company in the District of Delaware. Specifically, Purdue argues that the Company’s sale of immediate-release and extended-release Nucynta infringes U.S. Patent Nos. 9,861,583, 9,867,784, and 9,872,836. Purdue has made a demand for monetary relief in its complaint but has not quantified its alleged damages. On December 6, 2018, the Company filed an Amended Answer asserting an affirmative defense for patent exhaustion. On December 10, 2018, the Court granted the parties’ stipulation for resolution of the Company’s affirmative defense of patent exhaustion and stayed the action, with the exception of briefing on and resolution of the Company’s Motion for Judgment on the Pleadings related to patent exhaustion and any discovery related to that Motion. Also, on December 10, 2018, the Company filed a Rule 12(c) Motion for Judgment on the Pleadings, arguing that the Purdue’s claims were barred by the doctrine of patent exhaustion. Purdue filed its response on January 11, 2019 and the Company filed a reply on January 25, 2019. On June 18, 2019, the court heard oral argument on the Company’s Rule 12(c) Motion for Judgment on the Pleadings. On June 19, 2019, the court issued an order stating that “judgment in Collegium’s favor is warranted under the doctrine of patent exhaustion to the extent Collegium’s alleged infringing activities resulted from sales that fall within the scope of that covenant.” The court explained, however, that based on the current record, it was not possible “to determine whether title of the Nucynta Products was transferred to Collegium” from sales authorized by Purdue’s covenant not to sue. The court ordered discovery on this issue and the case remained “stayed with the exception of discovery and briefing on and resolution of the Company’s anticipated motion for summary judgment based on patent exhaustion.” On September 19, 2019, Purdue gave the court notice of its bankruptcy filing and sought the imposition of an automatic stay of the proceedings. The Nucynta litigation is subject to the automatic bankruptcy stay. Purdue has not sought to lift the automatic stay as to the Nucynta litigation. Pending resolution of the bankruptcy action, the Company plans to defend this case vigorously. At this stage, the Company is unable to evaluate the likelihood of an unfavorable outcome or estimate the amount or range of potential loss, if any. Teva Litigation The Company has fifteen patents listed in the FDA Orange Book as covering the Company’s abuse-deterrent product and methods of using it to treat patients: Patents Nos. 7,399,488; 7,771,707; 8,449,909; 8,557,291; 8,758,813; 8,840,928; 9,044,398; 9,248,195; 9,592,200; 9,682,075; 9,737,530, 9,763,883; 9,968,598; 10,004,729; and 10,188,644 (the “Orange Book Patents”). Teva Pharmaceuticals USA, Inc. (“Teva”) filed Notice Letters of Patent Certification against all of the fifteen listed Orange Book Patents alleging that they were invalid and/or not infringed by the proposed oxycodone products that are the subject of Teva’s Abbreviated New Drug Application (“ANDA”). On February 22, 2018—within the 45-day period that gives the Company a 30-month stay of FDA approval of Teva’s ANDA while the parties have an opportunity to litigate—the Company sued Teva in the District of Delaware on eleven of the Orange Book Patents. Teva responded to the Company’s complaint on May 14, 2018, alleging that the Orange Book Patents are invalid and are not infringed by Teva’s proposed ANDA products and asserting counterclaims of non-infringement and invalidity of the Orange Book Patents. The Company answered Teva’s counterclaims on June 4, 2018. The parties briefed claim construction and the court heard argument on April 12, 2019. On September 11, 2019, the Court issued a Report and Recommendation construing two of the six terms or sets of terms that are in dispute. The remaining terms will be addressed in one or more forthcoming Report and Recommendations. Fact discovery was scheduled to close on September 20, 2019 and expert discovery was scheduled to close on January 24, 2020. The Company filed a second lawsuit in the District of Delaware, asserting two additional Orange Book Patents, on November 30, 2018. Teva responded to the Company’s complaint on January 11, 2019, alleging that the asserted patents are invalid and are not infringed by Teva’s proposed ANDA products, and asserting counterclaims of non-infringement and invalidity of the asserted patents. The Company answered Teva’s counterclaims on February 1, 2019. The court consolidated the second suit with the first suit, and thus both suits are proceeding on the same schedule. The Company filed a third lawsuit in the District of Delaware, asserting one additional Orange Book Patent, on May 9, 2019. Teva responded to the Company’s complaint on June 6, 2019, alleging that the asserted patent is invalid and is not infringed by Teva’s proposed ANDA products, and asserting counterclaims of non-infringement and invalidity of the asserted patent. The Company answered Teva’s counterclaims on June 27, 2019. The parties filed a proposed Scheduling Order, which the Court entered on September 4, 2019. The parties have exchanged initial disclosures pursuant to that Order. On September 20, 2019, the parties jointly agreed to stay both litigations, which the Court so ordered. In June 2020, the Court ordered that the stay remain in place and that the parties shall file a joint status report regarding whether the stay should remain stayed by October 15, 2020. Once the stay is lifted, the Company plans to continue defending this case vigorously. Opioid Litigation On March 19, 2018, a lawsuit was filed by multiple local governments in the Circuit Court of Crittenden County, Arkansas, against the Company and other pharmaceutical manufacturers and distributors alleging a variety of claims related to opioid marketing and distribution practices. On January 29, 2019, the Company was dismissed from this litigation without prejudice. On March 21, 2018, the Company, along with other pharmaceutical manufacturers and distributors, was named in a class-action lawsuit filed in the Eastern District of Kentucky by a family practice clinic, on behalf of other similarly-situated healthcare providers. The action alleges violations of the Racketeer Influenced and Corrupt Organizations Act (“RICO”) relating to opioid marketing and distribution practices. On April 14, 2018, the lawsuit was conditionally transferred by the Judicial Panel on Multi-District Litigation to the federal Prescription Opiate Multi District Litigation (the “MDL”) in the Southern District of Ohio. On April 10, 2018, the conditional transfer was finalized and the lawsuit was docketed in the MDL on April 11, 2018. On May 4, 2018, the Company, along with other pharmaceutical manufacturers and distributors, were named in two lawsuits filed in the MDL by the Fiscal Court of Bourbon County, Kentucky and the Fiscal Court of Owen County, Kentucky, relating to opioid marketing and distribution practices. On July 11 and 12, 2018, the Company was named in four lawsuits filed in the MDL by a health system and various member hospitals. On September 26, 2018, the Company was named in two lawsuits filed in the MDL by the Fiscal Court of Lee County, Kentucky and the Fiscal Court of Wolfe County, Kentucky. On March 15, 2019, the plaintiffs in these MDL cases filed amended complaints which no longer name the Company as a defendant, effectively terminating these lawsuits as to the Company. On September 6, 2019, Triad Health Systems filed a class action lawsuit in the MDL on behalf of itself and similarly situated health care systems, generally alleging negligence, fraud, and violations of the RICO Act relating to opioid marketing and distribution practices, naming the Company and other pharmaceutical distributors and manufacturers. On October 18, 2019, three counties in Kentucky filed lawsuits in the MDL, naming the Company: the Fiscal Court of Casey County Kentucky; the Fiscal Court of Gallatin County Kentucky; and the Fiscal Court of Lewis County Kentucky. These On January 11, 2019, the City of Portsmouth filed a lawsuit in Virginia Circuit Court against the Company and other pharmaceutical manufacturers and distributors. The lawsuit alleges a variety of claims related to opioid marketing and distribution practices including public nuisance, common law fraud, negligent misrepresentation, negligence, and violations of state consumer protection laws. On October 3, 2019, the City of Portsmouth case was transferred to the MDL. On March 15, 2019, the Company was named in a lawsuit in the MDL by the City of Paterson, New Jersey. The lawsuit alleges violations of fraud, public nuisance, negligent misrepresentation, and violations of state consumer protection laws, and seeks, generally, penalties and/or injunctive relief. In April 2019, the City of Norwich, Connecticut and the Town of Enfield, Connecticut filed lawsuits in Connecticut Superior Court. The lawsuits allege violations of fraud, public nuisance, negligent misrepresentation, and violations of state consumer protection laws. On June 28, 2019, both cases were transferred to the MDL. In October 2019, the Company was named in additional Connecticut lawsuits: the City of Middletown and the Town of Wethersfield. These cases were both also transferred to the MDL in July 2019. On January 15, 2020, the Company was named in a new lawsuit in Connecticut Superior Court, filed by the Town of Windham. This case was removed and transferred to the MDL in March 2020. On June 14, 2019, the City of Trenton filed a lawsuit in New Jersey Superior Court against the Company and other pharmaceutical manufacturers and distributors. The lawsuit alleges a variety of claims related to opioid marketing and distribution practices including public nuisance, common law fraud, negligent misrepresentation, negligence, and violations of state consumer protection laws and the New Jersey Drug Dealer Liability Act. On August 23, 2019, the case was removed to the District Court of New Jersey. The plaintiff filed an opposition to coordination and requested remand, but on December 18, 2019, the case was transferred to the MDL. Each of the lawsuits in the MDL naming the Company seeks, generally, penalties and injunctive relief. None of the lawsuits naming the Company are designated as representative cases in the MDL, and therefore, are effectively currently stayed. On May 29, 2018, a lawsuit was filed by Bucks County, Pennsylvania against the Company and other pharmaceutical manufacturers and on June 12, 2018, a lawsuit was filed by Clinton County, Pennsylvania, against the Company and other pharmaceutical manufacturers and distributors. On June 6, 2018, a lawsuit was filed by Mercer County, Pennsylvania, against the Company and other pharmaceutical manufacturers and distributors. These lawsuits allege claims related to opioid marketing and distribution, including negligence, fraud, unjust enrichment, public nuisance, and violations of state consumer protections laws. These cases have been consolidated for discovery purposes in the Delaware County Court of Common Pleas as part of a consolidated proceeding of similar lawsuits brought by numerous Pennsylvania counties against other pharmaceutical manufacturers and distributors. In March 2019, three additional cases were filed in Pennsylvania by two payor groups and Warminster Township. The Company has been dismissed from both of the payor group cases. In July 2019, the Company learned of additional lawsuits alleging similar claims which were filed by Warrington Township in the Bucks County Court of Common Pleas, and filed by the City of Lock Haven in the Clinton County Court of Common Pleas. The City of Lock Haven and the Warrington Township cases have been coordinated into the consolidated proceeding before the Delaware County Court of Common Pleas. None of these cases have been designated a Track One case in which discovery would commence, and therefore are effectively stayed at present. On July 30, 2018, a lawsuit was filed by the City of Worcester, Massachusetts against the Company and other pharmaceutical manufacturers and distributors. The action alleges a variety of claims related to opioid marketing and distribution practices including public nuisance, common law fraud, negligent misrepresentation, negligence, violations of Mass Gen. Laws ch. 93A, Section 11, unjust enrichment and civil conspiracy. In February 2019, the City of Worcester case was transferred to the Business Litigation Session of the Superior Court. Additional lawsuits brought by the following cities and counties Massachusetts were filed between October 2018 and April 2019: City of Salem, City of Framingham, Town of Lynnfield, City of Springfield, City of Haverhill, City of Gloucester, Town of Canton, Town of Wakefield, City of Chicopee; Town of Natick; City of Cambridge, and Town of Randolph. Each of these additional lawsuits has been coordinated before the Business Litigation Session. The case brought by the City of Springfield was selected to advance for the purpose of motion practice, and defendants’ motions to dismiss were denied on January 3, 2020. The Company has answered the City of Cambridge complaint. For cases relevant to the Company, the Court selected the City of Springfield to advance as a bellwether case, with discovery in the remaining coordinated cases stayed. The Company disputes the allegations in these lawsuits and intends to vigorously defend these actions. At this stage, the Company is unable to evaluate the likelihood of an unfavorable outcome or estimate the amount or range of potential loss, if any. Opioid-Related Request and Subpoenas The Company, like a number of other pharmaceutical companies, has received subpoenas or civil investigative demands related to opioid sales and marketing. The Company has received such subpoenas or civil investigative demands from the Offices of the Attorney General of each of Washington, New Hampshire, Massachusetts, and Maryland. The Company is currently cooperating with each of the foregoing states in their respective investigations. |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2020 | |
Income Taxes | |
Income Taxes | 15. Income Taxes The income tax provision for the interim periods covered by this Quarterly Report on Form 10-Q reflects the Company’s estimate of the effective tax rates expected to be applicable for the full fiscal years, adjusted for any discrete events which are recorded in the period in which they occur. The estimates are reevaluated each quarter based on the Company’s estimated tax expense for the full fiscal year. The following table presents information regarding Company’s income tax expense recognized for the three and six months ended June 30, 2020 and 2019: Three months ended June 30, Six months ended June 30, 2020 2019 2020 2019 Provision for income taxes $ 246 $ — $ 246 $ — Effective tax rate 3.0% 0.0% 2.8% 0.0% The Company is subject to U.S. federal and state income taxes. For the three and six months ended June 30, 2020, the Company recorded income tax expense of $246, which reflects current state income taxes. Due to the utilization of net operating losses (or “NOLs”) carried forward, no current federal income tax expense was recorded. For the three and six months ended June 30, 2019, the Company did not record income tax expense due to the utilization of federal and state NOLs carried forward. The utilization of the Company’s NOLs has not resulted in any deferred federal tax expense because there was a full valuation allowance recorded with respect to the NOLs. Deferred tax assets and deferred tax liabilities are recognized based on temporary differences between the financial reporting and tax bases of assets and liabilities using statutory rates. The Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets, which are comprised principally of federal and state NOLs along with other tax credits. Under the applicable accounting standards, the Company considered its history of losses and concluded that it is more likely than not that the Company will not recognize the benefits of federal and state deferred tax assets. Accordingly, as of June 30, 2020, a full valuation allowance has been established against the Company’s otherwise recognizable net deferred tax assets. In March 2020, the Coronavirus Aid, Relief and Economic Security Act (“the CARES Act”) was signed into law. The CARES Act includes provisions relating to several aspects of corporate income taxes. The Company does not currently expect the CARES Act to have a significant impact on its provision for income taxes; however, it will continue to monitor the provisions of the CARES Act in relation to its operations. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2020 | |
Summary of Significant Accounting Policies | |
Basis of Accounting | Basis of Presentation The accompanying unaudited Condensed Consolidated Financial Statements include the accounts of Collegium Pharmaceutical, Inc. (a Virginia corporation) as well as the accounts of Collegium Securities Corp. (a Massachusetts corporation), incorporated in December 2015, and Collegium NF, LLC (a Delaware limited liability company), organized in December 2017, both wholly owned subsidiaries requiring consolidation. The consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial reporting and as required by Regulation S-X, Rule 10-01. Accordingly, they do not include all of the information and footnotes required by GAAP for complete consolidated financial statements. In the opinion of the Company’s management, the accompanying unaudited Condensed Consolidated Financial Statements contain all adjustments (consisting of items of a normal and recurring nature) necessary to fairly present the financial position of the Company as of June 30, 2020, the results of operations for the three and six months ended June 30, 2020 and 2019, and cash flows for the six months ended June 30, 2020 and 2019. The results of operations for the six months ended June 30, 2020 are not necessarily indicative of the results to be expected for the full year. The preparation of the Condensed Consolidated Financial Statements in accordance with GAAP requires the Company to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues, costs and expenses and the disclosure of contingent assets and liabilities in the Company’s consolidated financial statements and accompanying notes. Estimates in the Company’s consolidated financial statements include revenue recognition, including the estimates of product returns, units prescribed, discounts and allowances related to commercial sales of products, estimates of useful lives with respect to intangible assets, accounting for stock based compensation, contingencies, impairment of intangible assets, and tax valuation reserves. The Company bases estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances. The Company evaluates its estimates and assumptions on an ongoing basis. The Company’s actual results may differ from these estimates under different assumptions or conditions. The consolidated interim 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 fiscal year ended December 31, 2019 (the “Annual Report”). |
Embedded Derivatives | Embedded Derivatives The Company accounts for derivative financial instruments as either equity or liabilities in accordance with Accounting Standards Codification Topic 815, Derivatives and Hedging Other than the aforementioned changes, there have been no material changes in the Company’s significant accounting policies, other than the adoption of accounting pronouncements below, as compared to the significant accounting policies described in the Annual Report. |
Reclassifications | Reclassifications The Company has reclassified certain amounts in its Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2019 to conform to the 2020 presentation. Specifically, the Company disaggregated previously reported cost of product revenues of $48,654 for the three months ended June 30, 2019 into the captions Cost of product revenues (excluding intangible asset amortization) $44,966 and Intangible asset amortization $3,688. In addition, the Company disaggregated previously reported cost of product revenues of $97,818 for the six months ended June 30, 2019 into the captions Cost of product revenues (excluding intangible asset amortization) $90,442 and Intangible asset amortization $7,376. The reclassifications relate to the presentation of the Company’s gross profit and amortization expense and were made to provide the readers of the Company’s consolidated financial statements with additional insight into how the Company and its management view and evaluate its performance and profitability. This reclassification within the consolidated statements of operations for the three and six months ended June 30, 2019 had no impact on previously reported total consolidated revenues or consolidated results of operations. |
Recent Accounting Pronouncements | Recently Adopted Accounting Pronouncements New accounting pronouncements are issued periodically by the Financial Accounting Standards Board (“FASB”) and are adopted by the Company as of the specified effective dates. The Company adopted Accounting Standard Updated (“ASU”) 2016-13 , Financial Instruments – Credit Losses (ASC Topic 326): Measurement of Credit Losses on Financial Instruments, w In March 2020, the FASB issued ASU 2020-04, Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting December 31, 2022. Upon the transition of the Company’s contracts and transactions to new reference rates in connection with reference rate reform, the Company will prospectively apply the amendments of ASU 2020-04 and disclose the effect on its consolidated financial statements Recently Issued Accounting Pronouncements Not Yet Adopted In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes |
Revenue from Contracts with C_2
Revenue from Contracts with Customers (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Revenue from Contracts with Customers | |
Summary of product revenue provision and allowance | Trade Rebates and Product Allowances and Six months ended June 30, 2020 Incentives (1) Returns (2) Chargebacks (3) Balance at December 31, 2019 $ 129,901 $ 27,648 $ 14,020 Provision related to current period sales 162,637 6,703 37,230 Changes in estimate related to prior period sales (171) — 85 Credits/payments made (154,145) (1,520) (36,482) Balance at June 30, 2020 $ 138,222 $ 32,831 $ 14,853 Trade Rebates and Product Allowances and Six months ended June 30, 2019 Incentives (1) Returns (2) Chargebacks (3) Balance at December 31, 2018 $ 129,318 $ 15,465 $ 14,841 Provision related to current period sales 128,509 9,150 31,988 Changes in estimate related to prior period sales (3,017) — — Credits/payments made (119,659) (1,502) (32,673) Balance at June 30, 2019 $ 135,151 $ 23,113 $ 14,156 (1) Provisions for rebates and incentives includes managed care rebates, government rebates and co-pay program incentives. Provisions for rebates and incentives are deducted from gross revenues at the time revenues are recognized and are included in accrued rebates, returns and discounts in the Company’s Consolidated Condensed Balance Sheets. (2) Provisions for product returns are deducted from gross revenues at the time revenues are recognized and are included in accrued rebates, returns and discounts in the Company’s Condensed Consolidated Balance Sheets. (3) Provisions for trade allowances and chargebacks include fees for distribution service fees, prompt pay discounts, and chargebacks. Trade allowances and chargebacks are deducted from gross revenue at the time revenues are recognized and are recorded as a reduction to accounts receivable in the Company’s Condensed Consolidated Balance Sheets. |
Schedule of disaggregation of revenue | Three months ended June 30, Six months ended June 30, 2020 2019 2020 2019 Xtampza ER $ 33,557 $ 26,018 $ 65,064 $ 51,152 Nucynta Products (1) 44,501 49,022 89,505 98,404 Total product revenues, net $ 78,058 $ 75,040 $ 154,569 $ 149,556 (1) For the three months ended June 30, 2020, the Company recognized Nucynta IR and Nucynta ER product revenues, net of $29,073 and $15,427, respectively. For the three months ended June 30, 2019, the Company recognized Nucynta IR and Nucynta ER product revenues, net of $29,461 and $19,561, respectively. For the six months ended June 30, 2020, the Company recognized Nucynta IR and Nucynta ER product revenues, net of $57,044 and $32,461, respectively. For the six months ended June 30, 2019, the Company recognized Nucynta IR and Nucynta ER product revenues, net of $59,322 and $39,082, respectively. |
Earnings Per Share (Tables)
Earnings Per Share (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Earnings Per Share | |
Schedule of computations of basic and diluted net (loss) per share | Three months ended June 30, Six months ended June 30, 2020 2019 (1) 2020 2019 (1) Numerator: Net income (loss) $ 8,058 $ (4,712) $ 8,508 $ (14,412) Denominator: Weighted-average shares outstanding - basic 34,395,266 33,397,709 34,247,977 33,338,243 Effect of dilutive securities: Stock options 432,688 — 491,985 — Restricted stock units 212,221 — 262,849 — Performance share units 8,796 — 8,459 — Employee Stock Purchase Program 22,822 31,608 Warrants 20,113 — 46,862 — Weighted average shares outstanding - diluted 35,091,906 33,397,709 35,089,740 33,338,243 Earnings (loss) per share — basic $ 0.23 $ (0.14) $ 0.25 $ (0.43) Earnings (loss) per share — diluted $ 0.23 $ (0.14) $ 0.24 $ (0.43) (1) The Company incurred a net loss for the three and six months ended June 30, 2019, causing inclusion of any potentially dilutive securities to have an anti-dilutive effect, which resulted in basic loss per share and dilutive loss per share being equivalent. |
Schedule of potentially dilutive securities excluded from computations of diluted weighted-average shares outstanding | Three months ended June 30, Six months ended June 30, 2020 2019 2020 2019 Stock options 2,361,601 4,190,116 2,269,895 4,190,116 Warrants — 1,041,667 — 1,041,667 Restricted stock units 722,388 892,237 648,842 892,237 Performance share units 267,498 99,400 267,498 99,400 Convertible senior notes 4,925,134 — 4,925,134 — |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Fair Value of Financial Instruments | |
Schedule of financial instruments measured at fair value by level within fair value hierarchy | Significant Quoted Prices other Significant in active observable unobservable markets inputs inputs Total (Level 1) (Level 2) (Level 3) June 30, 2020 Money market funds, included in cash equivalents $ 45,065 $ 45,065 $ — $ — December 31, 2019 Money market funds, included in cash equivalents $ 94,841 $ 94,841 $ — $ — |
Inventory (Tables)
Inventory (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Inventory | |
Schedule of Inventory | As of June 30, As of December 31, 2020 2019 Raw materials $ 5,153 $ 795 Work in process 2,643 1,427 Finished goods 11,019 7,421 Total inventory $ 18,815 $ 9,643 |
Intangible Asset (Tables)
Intangible Asset (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Intangible Asset | |
Carrying amount of Nucynta intangible | As of June 30, As of December 31, 2020 2019 Gross carrying amount $ 521,170 $ 154,089 Accumulated amortization (151,676) (124,586) Intangible asset, net $ 369,494 $ 29,503 Gross Carrying Value Accumulated Amortization Net Book Value Intangible Asset, net Cost basis as of acquisition date $ 515,627 $ — $ 515,627 Amortization expense from acquisition date through Third Amendment Date — (107,662) (107,662) Adjustment due to the remeasurement of liability as of Third Amendment Date (369,581) — (369,581) Additional costs incurred as of Third Amendment Date (1) 8,043 — 8,043 Amortization expense from Amendment Date through fiscal year end — (2,172) (2,172) Balance as of December 31, 2018 $ 154,089 $ (109,834) $ 44,255 Amortization expense — (14,752) (14,752) Balance as of December 31, 2019 $ 154,089 $ (124,586) $ 29,503 Amortization expense through Nucynta Acquisition — (1,754) (1,754) Additional cost incurred from Nucynta Acquisition 367,081 — 367,081 Amortization expense from Nucynta Acquisition through period end — (25,336) (25,336) Balance as of June 30, 2020: $ 521,170 $ (151,676) $ 369,494 (1) Represents fair value of warrant issued in connection with the Amendment to the Nucynta Commercialization Agreement. |
Summary of costs included in acquired asset | Acquisition consideration: Base purchase price $ 375,000 Cash paid for inventory 6,030 Transaction costs 6,297 Reduction for 2020 cash transferred to Assertio under the prior Nucynta Commercialization Agreement (1) (13,071) Reduction for accrued royalty obligation discharged upon closing (1) (1,145) Total acquisition consideration: $ 373,111 (1) Represents $14,216 total reduction to the base purchase price comprising of $13,071 of cash payments transferred to Assertio under the prior Nucynta Commercialization Agreement as well as a reduction for discharged pre-acquisition accrued royalties based on sales from January 1, 2020 through closing. The Company then allocated the consideration transferred to the individual assets acquired on a relative fair value basis as summarized in the table below: Assets acquired: Nucynta Intangible Asset $ 367,081 Inventory 6,030 Total consideration allocated to assets acquired: $ 373,111 |
Summary of amortization expense | Three months ended June 30, Six months ended June 30, 2020 2019 2020 2019 Nucynta amortization expense included in cost of product revenues $ 16,795 $ 3,688 $ 27,090 $ 7,376 |
Schedule of remaining amortization period | Years ended December 31, Amortization Expense 2020 $ 33,590 2021 67,181 2022 67,181 2023 67,181 2024 67,181 2025 67,180 Remaining amortization expense: $ 369,494 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Accrued Expenses | |
Schedule of components of accrued expenses | As of June 30, As of December 31, 2020 2019 Accrued royalties $ 12,531 $ 21,893 Accrued product taxes and fees 3,903 — Accrued bonuses 2,331 4,047 Accrued incentive compensation 1,586 1,650 Accrued interest 1,436 473 Accrued payroll and related benefits 1,284 1,154 Accrued audit and legal 623 308 Accrued sales and marketing 424 775 Accrued other operating costs 993 3,180 Total accrued expenses $ 25,111 $ 33,480 |
Term Notes Payable (Tables)
Term Notes Payable (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Pharmakon Term Notes [Member] | |
Debt Instrument [Line Items] | |
Schedule of future payments under debt agreements | As of June 30, 2020, scheduled principal repayments under the term notes are as follows: Years ended December 31, Principal Payments 2020 $ 25,000 2021 50,000 2022 37,500 2023 50,000 2024 25,000 Total before unamortized discount and issuance costs $ 187,500 Less: unamortized discount and issuance costs (6,569) Total term notes $ 180,931 |
Convertible Senior Notes (Table
Convertible Senior Notes (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Debt Instrument [Line Items] | |
Summary of convertible notes outstanding | Liability component: Principal $ 143,750 Less: unamortized debt discount and issuance costs (47,704) Net carrying amount $ 96,046 Equity component, net of issuance costs of $1,773 $ 44,777 |
Schedule of total interest expense recognized related to the convertible notes | Three months ended June 30, Six months ended June 30, 2020 2020 Contractual interest expense $ 933 $ 1,436 Amortization of debt discount 1,540 2,359 Amortization of debt issuance costs 122 188 Total interest expense $ 2,595 $ 3,983 |
Convertible senior notes | |
Debt Instrument [Line Items] | |
Schedule of principal repayments of debt | As of June 30, 2020, the future minimum payments on the convertible notes were as follows: Years ended December 31, Future Minimum Payments 2020 $ 1,908 2021 3,773 2022 3,773 2023 3,773 2024 3,773 Thereafter 149,412 Total minimum payments $ 166,412 Less: interest (22,662) Less: unamortized debt discount and issuance costs (47,704) Convertible senior notes $ 96,046 |
Equity (Tables)
Equity (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Equity | |
Summary of changes in Shareholders' Equity | The changes in shareholders’ equity for six months ended June 30, 2020 were as follows: Additional Total Common Stock Paid- In Accumulated Shareholders’ Shares Amount Capital Deficit Equity (Deficit) Balance, December 31, 2019 33,678,840 $ 34 $ 447,297 $ (359,899) $ 87,432 Exercise of common stock options 455,573 — 4,454 — 4,454 Issuance for employee stock purchase plan 39,411 — 357 — 357 Vesting of restricted stock units ("RSUs") 195,280 — — — — Shares withheld for employee taxes upon vesting of RSUs (63,064) — (1,358) — (1,358) Stock-based compensation — — 4,951 — 4,951 Equity component of 2020 Convertible Notes, net of issuance costs of $1,773 — — 44,777 — 44,777 Net income — — — 450 450 Balance, March 31, 2020 34,306,040 $ 34 $ 500,478 $ (359,449) $ 141,063 Exercise of common stock options 131,562 — 1,626 — 1,626 Vesting of RSUs 83,461 — — — — Shares withheld for employee taxes upon vesting of RSUs (26,761) — (564) — (564) Stock-based compensation — — 5,584 — 5,584 Net income — — — 8,058 8,058 Balance, June 30, 2020 34,494,302 $ 34 $ 507,124 $ (351,391) $ 155,767 The changes in shareholders’ equity for six months ended June 30, 2019 were as follows: Additional Total Common Stock Paid- In Accumulated Shareholders’ Shares Amount Capital Deficit Equity (Deficit) Balance, December 31, 2018 33,265,629 $ 33 $ 428,729 $ (337,177) $ 91,585 Exercise of common stock options 18,693 — 246 — 246 Issuance for employee stock purchase plan 32,826 — 444 — 444 Vesting of RSUs 101,483 — — — — Shares withheld for employee taxes upon vesting of RSUs (33,503) — (488) — (488) Stock-based compensation — — 4,263 — 4,263 Net loss — — — (9,700) (9,700) Balance, March 31, 2019 33,385,128 $ 33 $ 433,194 $ (346,877) $ 86,350 Exercise of common stock options 8,218 — 58 — 58 Vesting of RSUs 26,304 — — — — Shares withheld for employee taxes upon vesting of RSUs (3,097) — (35) — (35) Stock-based compensation — — 4,162 — 4,162 Net loss — — — (4,712) (4,712) Balance, June 30, 2019 33,416,553 $ 33 $ 437,379 $ (351,589) $ 85,823 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Stock-based Compensation | |
Summary of stock-based compensation | Three months ended June 30, Six months ended June 30, 2020 2019 2020 2019 Research and development expenses $ 984 $ 514 $ 1,754 $ 1,081 Selling, general and administrative expenses 4,600 3,648 8,781 7,344 Total stock-based compensation expense $ 5,584 $ 4,162 $ 10,535 $ 8,425 |
Summary of performance share units activity | Weighted-Average Shares Grant Date Fair Value Outstanding at December 31, 2019 99,400 $ 15.90 Granted 187,978 28.49 Vested — — Forfeited — — Performance adjustment (4,155) 15.90 Outstanding at June 30, 2020 283,223 $ 24.26 |
Summary of restricted stock units activity | Weighted-Average Shares Grant Date Fair Value Outstanding at December 31, 2019 849,679 $ 17.10 Granted 762,607 21.37 Vested (278,741) 17.97 Forfeited (16,025) 18.87 Outstanding at June 30, 2020 1,317,520 $ 19.37 |
Summary of stock option activity | Weighted- Weighted- Average Average Remaining Aggregate Exercise Price Contractual Intrinsic Shares per Share Term (in years) Value Outstanding at December 31, 2019 3,955,887 $ 16.00 7.5 $ 21,257 Granted 701,249 21.39 Exercised (587,135) 10.36 Cancelled (98,551) 20.69 Outstanding at June 30, 2020 3,971,450 $ 17.67 7.7 $ 7,866 Exercisable at June 30, 2020 2,123,646 $ 16.95 6.7 $ 5,058 |
Schedule of fair value assumption using Black-Scholes option-pricing model | Six months ended June 30, 2020 2019 Risk-free interest rate 1.3 % 2.6 % Volatility 66.1 % 63.3 % Expected term (years) 6.1 6.1 Expected dividend yield — % — % |
Income Taxes (Tables)
Income Taxes (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Income Taxes | |
Schedule of income tax expense recognized | Three months ended June 30, Six months ended June 30, 2020 2019 2020 2019 Provision for income taxes $ 246 $ — $ 246 $ — Effective tax rate 3.0% 0.0% 2.8% 0.0% |
Nature of Business (Details)
Nature of Business (Details) - Assertio - Nucynta Purchase Agreement - Nucynta Products $ in Thousands | Feb. 06, 2020USD ($) |
Aggregate purchase price | $ 375,000 |
Royalty payment as percentage of annual net sales | 14.00% |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Cost of product revenues | $ 29,694 | $ 48,654 | $ 67,218 | $ 97,818 |
Cost of product revenues (excluding intangible asset amortization) | 12,899 | 44,966 | 40,128 | 90,442 |
Intangible asset amortization | $ 16,795 | 3,688 | $ 27,090 | 7,376 |
Adjustment | ||||
Cost of product revenues | 48,654 | 97,818 | ||
Cost of product revenues (excluding intangible asset amortization) | 44,966 | 90,442 | ||
Intangible asset amortization | $ 3,688 | $ 7,376 |
Revenue from Contracts with C_3
Revenue from Contracts with Customers - Narrative (Details) | 6 Months Ended |
Jun. 30, 2020 | |
Disaggregation of Revenue [Line Items] | |
Practical expedient incremental cost | true |
Minimum | |
Disaggregation of Revenue [Line Items] | |
Term of payment received | 30 days |
Maximum | |
Disaggregation of Revenue [Line Items] | |
Term of payment received | 90 days |
Revenue from Contracts with C_4
Revenue from Contracts with Customers - Transaction Price and Variable Consideration (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | |
Rebates and Incentives | ||
Allowance categories | ||
Balance at beginning of the period | $ 129,901 | $ 129,318 |
Provision related to current period sales | 162,637 | 128,509 |
Changes in estimate related to prior period sales | (171) | (3,017) |
Credits/payments made | (154,145) | (119,659) |
Balance at end of the period | 138,222 | 135,151 |
Product Returns | ||
Allowance categories | ||
Balance at beginning of the period | 27,648 | 15,465 |
Provision related to current period sales | 6,703 | 9,150 |
Credits/payments made | (1,520) | (1,502) |
Balance at end of the period | 32,831 | 23,113 |
Trade Allowances and Chargebacks | ||
Allowance categories | ||
Balance at beginning of the period | 14,020 | 14,841 |
Provision related to current period sales | 37,230 | 31,988 |
Changes in estimate related to prior period sales | 85 | |
Credits/payments made | (36,482) | (32,673) |
Balance at end of the period | $ 14,853 | $ 14,156 |
Revenue from Contracts with C_5
Revenue from Contracts with Customers - Disaggregation of Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Disaggregation of Revenue | ||||
Product revenues, net | $ 78,058 | $ 75,040 | $ 154,569 | $ 149,556 |
Xtampza ER | ||||
Disaggregation of Revenue | ||||
Product revenues, net | 33,557 | 26,018 | 65,064 | 51,152 |
Nucynta Products | ||||
Disaggregation of Revenue | ||||
Product revenues, net | 44,501 | 49,022 | 89,505 | 98,404 |
Nucynta IR | ||||
Disaggregation of Revenue | ||||
Product revenues, net | 29,073 | 29,461 | 57,044 | 59,322 |
Nucynta ER | ||||
Disaggregation of Revenue | ||||
Product revenues, net | $ 15,427 | $ 19,561 | $ 32,461 | $ 39,082 |
License Agreements (Details)
License Agreements (Details) - USD ($) $ / shares in Units, $ in Thousands | Feb. 06, 2020 | Jan. 09, 2018 | Nov. 30, 2018 | Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 |
License Agreements [Line Items] | |||||||
License fee | $ 29,694 | $ 48,654 | $ 67,218 | $ 97,818 | |||
Annual net sales | 78,058 | 75,040 | 154,569 | 149,556 | |||
Nucynta Products | |||||||
License Agreements [Line Items] | |||||||
Annual net sales | $ 44,501 | $ 49,022 | $ 89,505 | $ 98,404 | |||
Nucynta Commercialization Agreement | Assertio | |||||||
License Agreements [Line Items] | |||||||
License fee | $ 10,000 | ||||||
Nucynta Commercialization Agreement | Nucynta Products | Assertio | |||||||
License Agreements [Line Items] | |||||||
Payment for inventory | 6,223 | ||||||
Reimbursement for prepaid expenses | 1,987 | ||||||
Liability relating to sales | 22,660 | ||||||
Annual net sales | 135,000 | ||||||
Quarterly royalty payable | 33,750 | ||||||
Base annual net sales for variable royalty | $ 233,000 | ||||||
Third Amendment to the Commercialization Agreement | |||||||
License Agreements [Line Items] | |||||||
Number of shares that can be purchased | 1,041,667 | ||||||
Exercise price of warrant | $ 19.20 | ||||||
Third Amendment to the Commercialization Agreement | Nucynta Products | |||||||
License Agreements [Line Items] | |||||||
Minimum royalty payment eliminated | $ 135,000 | ||||||
Third Amendment to the Commercialization Agreement | Nucynta Products | Maximum | Any 12-month period through January 1, 2022 | |||||||
License Agreements [Line Items] | |||||||
Net sales limit upon which Counterparty can terminate without penalty | 180,000 | ||||||
Third Amendment to the Commercialization Agreement | Nucynta Products | Maximum | Any 12-month period commencing on January 1, 2022 | |||||||
License Agreements [Line Items] | |||||||
Net sales limit upon which Counterparty can terminate without penalty | $ 170,000 | ||||||
Third Amendment to the Commercialization Agreement | Nucynta Products | Assertio | Sales Royalty Structure 1 | |||||||
License Agreements [Line Items] | |||||||
Royalty payment as percentage of annual net sales | 65.00% | ||||||
Royalty payment limit between January 1, 2019 and December 31, 2021 | $ 180,000 | ||||||
Collaborative Arrangement, Royalty Payment Limit | $ 180,000 | ||||||
Third Amendment to the Commercialization Agreement | Nucynta Products | Assertio | Sales Royalty Structure 2 | |||||||
License Agreements [Line Items] | |||||||
Royalty payment as percentage of annual net sales | 14.00% | ||||||
Third Amendment to the Commercialization Agreement | Nucynta Products | Assertio | Sales Royalty Structure 3 | |||||||
License Agreements [Line Items] | |||||||
Royalty payment as percentage of annual net sales | 58.00% | ||||||
Third Amendment to the Commercialization Agreement | Nucynta Products | Assertio | Sales Royalty Structure 4 | |||||||
License Agreements [Line Items] | |||||||
Royalty payment as percentage of annual net sales | 20.00% | ||||||
Third Amendment to the Commercialization Agreement | Nucynta Products | Assertio | Sales Royalty Structure 5 | |||||||
License Agreements [Line Items] | |||||||
Royalty payment as percentage of annual net sales | 15.00% | ||||||
Third Amendment to the Commercialization Agreement | Nucynta Products | Assertio | prior to January 1, 2022 | |||||||
License Agreements [Line Items] | |||||||
Royalty payment as percentage of annual net sales | 14.00% | ||||||
Royalty payment limit between January 1, 2019 and December 31, 2021 | $ 34,000 | ||||||
Collaborative Arrangement, Royalty Payment Limit | 34,000 | ||||||
Third Amendment to the Commercialization Agreement | Nucynta Products | Assertio | Minimum | Sales Royalty Structure 2 | |||||||
License Agreements [Line Items] | |||||||
Royalty payment limit between January 1, 2019 and December 31, 2021 | 180,000 | ||||||
Collaborative Arrangement, Royalty Payment Limit | 180,000 | ||||||
Third Amendment to the Commercialization Agreement | Nucynta Products | Assertio | Minimum | Sales Royalty Structure 3 | |||||||
License Agreements [Line Items] | |||||||
Royalty payment limit between January 1, 2019 and December 31, 2021 | 210,000 | ||||||
Collaborative Arrangement, Royalty Payment Limit | 210,000 | ||||||
Third Amendment to the Commercialization Agreement | Nucynta Products | Assertio | Minimum | Sales Royalty Structure 4 | |||||||
License Agreements [Line Items] | |||||||
Royalty payment limit between January 1, 2019 and December 31, 2021 | 233,000 | ||||||
Collaborative Arrangement, Royalty Payment Limit | 233,000 | ||||||
Third Amendment to the Commercialization Agreement | Nucynta Products | Assertio | Minimum | Sales Royalty Structure 5 | |||||||
License Agreements [Line Items] | |||||||
Royalty payment limit between January 1, 2019 and December 31, 2021 | 258,000 | ||||||
Collaborative Arrangement, Royalty Payment Limit | 258,000 | ||||||
Third Amendment to the Commercialization Agreement | Nucynta Products | Assertio | Minimum | prior to January 1, 2022 | |||||||
License Agreements [Line Items] | |||||||
Royalty payment limit between January 1, 2019 and December 31, 2021 | 180,000 | ||||||
Collaborative Arrangement, Royalty Payment Limit | 180,000 | ||||||
Third Amendment to the Commercialization Agreement | Nucynta Products | Assertio | Maximum | Sales Royalty Structure 2 | |||||||
License Agreements [Line Items] | |||||||
Royalty payment limit between January 1, 2019 and December 31, 2021 | 210,000 | ||||||
Collaborative Arrangement, Royalty Payment Limit | 210,000 | ||||||
Third Amendment to the Commercialization Agreement | Nucynta Products | Assertio | Maximum | Sales Royalty Structure 3 | |||||||
License Agreements [Line Items] | |||||||
Royalty payment limit between January 1, 2019 and December 31, 2021 | 233,000 | ||||||
Collaborative Arrangement, Royalty Payment Limit | 233,000 | ||||||
Third Amendment to the Commercialization Agreement | Nucynta Products | Assertio | Maximum | Sales Royalty Structure 4 | |||||||
License Agreements [Line Items] | |||||||
Royalty payment limit between January 1, 2019 and December 31, 2021 | 258,000 | ||||||
Collaborative Arrangement, Royalty Payment Limit | 258,000 | ||||||
Third Amendment to the Commercialization Agreement | Nucynta Products | Assertio | Maximum | prior to January 1, 2022 | |||||||
License Agreements [Line Items] | |||||||
Royalty payment limit between January 1, 2019 and December 31, 2021 | 243,000 | ||||||
Collaborative Arrangement, Royalty Payment Limit | $ 243,000 | ||||||
Nucynta Purchase Agreement | Nucynta Products | Assertio | |||||||
License Agreements [Line Items] | |||||||
Royalty payment as percentage of annual net sales | 14.00% | ||||||
Aggregate purchase price | $ 375,000 | ||||||
Guaranteed royalty | 34,000 | ||||||
Nucynta Purchase Agreement | Nucynta Products | Assertio | Minimum | |||||||
License Agreements [Line Items] | |||||||
Royalty payment limit between January 1, 2019 and December 31, 2021 | 180,000 | ||||||
Collaborative Arrangement, Royalty Payment Limit | 180,000 | ||||||
Nucynta Purchase Agreement | Nucynta Products | Assertio | Maximum | |||||||
License Agreements [Line Items] | |||||||
Royalty payment limit between January 1, 2019 and December 31, 2021 | 243,000 | ||||||
Collaborative Arrangement, Royalty Payment Limit | $ 243,000 |
Earnings Per Share - Computatio
Earnings Per Share - Computation of Net Loss per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2020 | Mar. 31, 2020 | Jun. 30, 2019 | Mar. 31, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Net loss per common share | ||||||
Net income (loss) | $ 8,058 | $ 450 | $ (4,712) | $ (9,700) | $ 8,508 | $ (14,412) |
Weighted-average shares - basic (in shares) | 34,395,266 | 33,397,709 | 34,247,977 | 33,338,243 | ||
Weighted-average shares - diluted (in shares) | 35,091,906 | 33,397,709 | 35,089,740 | 33,338,243 | ||
Earnings (loss) per share - basic (in dollars per share) | $ 0.23 | $ (0.14) | $ 0.25 | $ (0.43) | ||
Earnings (loss) per share - diluted (in dollars per share) | $ 0.23 | $ (0.14) | $ 0.24 | $ (0.43) | ||
Stock options | ||||||
Net loss per common share | ||||||
Effect of dilutive securities | 432,688 | 491,985 | ||||
Restricted stock units | ||||||
Net loss per common share | ||||||
Effect of dilutive securities | 212,221 | 262,849 | ||||
Performance share units | ||||||
Net loss per common share | ||||||
Effect of dilutive securities | 8,796 | 8,459 | ||||
Employee Stock Purchase Program | ||||||
Net loss per common share | ||||||
Effect of dilutive securities | 22,822 | 31,608 | ||||
Warrants | ||||||
Net loss per common share | ||||||
Effect of dilutive securities | 20,113 | 46,862 |
Earnings Per Share - Summary of
Earnings Per Share - Summary of Potentially Dilutive Securities (Details) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Stock options | ||||
Anti-dilutive securities | ||||
Potentially dilutive securities excluded from the computations of diluted weighted-average shares outstanding | 2,361,601 | 4,190,116 | 2,269,895 | 4,190,116 |
Warrants | ||||
Anti-dilutive securities | ||||
Potentially dilutive securities excluded from the computations of diluted weighted-average shares outstanding | 1,041,667 | 1,041,667 | ||
Restricted stock units | ||||
Anti-dilutive securities | ||||
Potentially dilutive securities excluded from the computations of diluted weighted-average shares outstanding | 722,388 | 892,237 | 648,842 | 892,237 |
Performance share units | ||||
Anti-dilutive securities | ||||
Potentially dilutive securities excluded from the computations of diluted weighted-average shares outstanding | 267,498 | 99,400 | 267,498 | 99,400 |
Convertible senior notes | ||||
Anti-dilutive securities | ||||
Potentially dilutive securities excluded from the computations of diluted weighted-average shares outstanding | 4,925,134 | 4,925,134 |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments (Details) - USD ($) $ in Thousands | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | |
Transfer of Assets From Level 1 to Level 2 | $ 0 | $ 0 | |
Transfer of Assets From Level 2 to Level 1 | 0 | 0 | |
Transfer of Liabilities From Level 1 to Level 2 | 0 | 0 | |
Transfer of Liabilities From Level 2 to Level 1 | 0 | 0 | |
Transfer of Assets Into Level 3 | 0 | 0 | |
Transfer of Assets Out of Level 3 | 0 | 0 | |
Transfer of Liabilities Into Level 3 | 0 | 0 | |
Transfer of Liabilities Out of Level 3 | 0 | $ 0 | |
Convertible senior notes, fair value | 129,151 | ||
Net carrying value | 96,046 | ||
Money market funds | |||
Cash equivalents | 45,065 | $ 94,841 | |
Quoted Prices in active markets (Level 1) | Money market funds | |||
Cash equivalents | $ 45,065 | $ 94,841 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2020 | Dec. 31, 2019 | |
Inventory | |||
Raw materials | $ 5,153 | $ 5,153 | $ 795 |
Work in process | 2,643 | 2,643 | 1,427 |
Finished goods | 11,019 | 11,019 | 7,421 |
Total inventory | 18,815 | 18,815 | $ 9,643 |
Inventory used in the construction and installation of property and equipment | $ 219 | $ 613 |
Intangible Assets - Gross Carry
Intangible Assets - Gross Carrying amount and Accumulated Amortization (Details) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Jan. 09, 2018 |
Gross carrying amount | $ 154,089 | |||
Accumulated amortization | (124,586) | |||
Intangible assets, net | $ 369,494 | 29,503 | ||
Nucynta Products | ||||
Gross carrying amount | 521,170 | 154,089 | $ 154,089 | $ 515,627 |
Accumulated amortization | (151,676) | (124,586) | (109,834) | |
Intangible assets, net | $ 369,494 | $ 29,503 | $ 44,255 |
Intangible Assets - Costs Accum
Intangible Assets - Costs Accumulated to Acquire Intangible Asset and Consideration Transferred (Details) - Nucynta Products - USD ($) $ in Thousands | Feb. 06, 2020 | Jun. 30, 2020 |
Acquisition consideration: | ||
Base purchase price | $ 375,000 | |
Cash paid for inventory | 6,030 | |
Transaction costs | 6,297 | |
Reduction for 2020 cash transferred to Assertio under the prior Nucynta Commercialization Agreement(1) | (13,071) | |
Reduction for accrued royalty obligation discharged upon closing(1) | (1,145) | |
Total acquisition consideration | 373,111 | |
Reduction to base purchase price | 14,216 | |
Consideration transferred to assets acquired: | ||
Nucynta Intangible Asset | 367,081 | |
Inventory | 6,030 | |
Total consideration allocated to assets acquired | $ 373,111 | |
Assertio | Nucynta Purchase Agreement | ||
Finite-Lived Intangible Assets [Line Items] | ||
Aggregate purchase price | $ 375,000 |
Intangible Assets - Minimum Roy
Intangible Assets - Minimum Royalty Payments - Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | ||
Jun. 30, 2020 | Dec. 31, 2018 | Nov. 30, 2018 | |
Finite-Lived Intangible Assets [Line Items] | |||
Fair value of warrant | $ 8,043 | ||
Nucynta Commercialization Agreement | |||
Finite-Lived Intangible Assets [Line Items] | |||
Annual minimum royalty payments | 537,000 | ||
2018 | 132,000 | ||
2019 | 135,000 | ||
2020 | 135,000 | ||
2021 | 135,000 | ||
Fair Value of future minimum royalty payments | $ 482,300 | ||
Discounted rate | 5.70% | ||
Interest expense recognized | $ 54,700 | ||
Interest expense recognized, relating to royalty payments, prior to third amendment | 19,281 | ||
Amortization expense recognized prior to third amendment | $ 107,662 | ||
Third Amendment to the Commercialization Agreement | |||
Finite-Lived Intangible Assets [Line Items] | |||
Annual minimum royalty payments | $ 132,000 | ||
Common stock that may be purchased upon exercise of warrant (in shares) | 1,041,667 | ||
Exercise price of warrant (in dollars per share) | $ 19.20 |
Intangible Assets - Gross car_2
Intangible Assets - Gross carrying amount, accumulated amortization, and net book value (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | 10 Months Ended | 12 Months Ended | ||||||
Feb. 06, 2020 | Feb. 05, 2020 | Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Nov. 07, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Nov. 08, 2018 | Jan. 09, 2018 | |
Gross carrying amount | $ 154,089 | ||||||||||
Amortization expense | $ (16,795) | $ (3,688) | $ (27,090) | $ (7,376) | (14,752) | ||||||
Accumulated amortization | (124,586) | ||||||||||
Intangible assets, net | 369,494 | 369,494 | 29,503 | ||||||||
Nucynta Products | |||||||||||
Gross carrying amount | 521,170 | 521,170 | 154,089 | $ 154,089 | $ 515,627 | ||||||
Amortization expense | $ (107,662) | (2,172) | |||||||||
Accumulated amortization | (151,676) | (151,676) | (124,586) | (109,834) | |||||||
Adjustment due to remeasurement of liability | $ (369,581) | ||||||||||
Additional costs incurred | $ 8,043 | ||||||||||
Intangible assets, net | 369,494 | 369,494 | $ 29,503 | $ 44,255 | |||||||
Nucynta Purchase Agreement | |||||||||||
Gross carrying amount | 521,170 | 521,170 | |||||||||
Amortization expense | $ (25,336) | $ (1,754) | |||||||||
Accumulated amortization | (151,676) | (151,676) | |||||||||
Additional costs incurred | $ 367,081 | ||||||||||
Intangible assets, net | $ 369,494 | $ 369,494 |
Intangible Assets - Amortizatio
Intangible Assets - Amortization (Details) - USD ($) $ in Thousands | Jan. 09, 2018 | Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Nov. 07, 2018 | Dec. 31, 2019 | Dec. 31, 2018 |
Finite-Lived Intangible Assets [Line Items] | ||||||||
Useful life | 5 years 6 months | |||||||
Amortization expense recognized prior to third amendment | $ 126,340 | |||||||
Nucynta amortization expense included in cost of product revenues | $ 16,795 | $ 3,688 | 27,090 | $ 7,376 | $ 14,752 | |||
2020 | 33,590 | 33,590 | ||||||
2021 | 67,181 | 67,181 | ||||||
2022 | 67,181 | 67,181 | ||||||
2023 | 67,181 | 67,181 | ||||||
2024 | 67,181 | 67,181 | ||||||
2025 | 67,180 | 67,180 | ||||||
Intangible assets, net | 369,494 | $ 369,494 | 29,503 | |||||
Nucynta Products | ||||||||
Finite-Lived Intangible Assets [Line Items] | ||||||||
Useful life | 4 years | 5 years 10 months 24 days | ||||||
Nucynta amortization expense included in cost of product revenues | $ 107,662 | $ 2,172 | ||||||
Intangible assets, net | $ 369,494 | $ 369,494 | $ 29,503 | $ 44,255 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Accrued Expenses | ||
Accrued royalties | $ 12,531 | $ 21,893 |
Accrued product taxes and fees | 3,903 | |
Accrued bonuses | 2,331 | 4,047 |
Accrued incentive compensation | 1,586 | 1,650 |
Accrued interest | 1,436 | 473 |
Accrued payroll and related benefits | 1,284 | 1,154 |
Accrued audit and legal | 623 | 308 |
Accrued sales and marketing | 424 | 775 |
Accrued other operating costs | 993 | 3,180 |
Total accrued expenses | $ 25,111 | $ 33,480 |
Term Notes Payable - Pharmakon
Term Notes Payable - Pharmakon (Details) - Pharmakon Term Notes [Member] - USD ($) $ in Thousands | Feb. 06, 2020 | Jun. 30, 2020 | Jun. 30, 2020 |
Debt | |||
Aggregate principal amount | $ 200,000 | ||
Margin rate | 7.50% | ||
Debt maturity | 48 months | ||
Facility fee (as a percent) | 2.50% | ||
Facility fee amount | $ 5,000 | ||
Debt issuance costs | 427 | ||
Net proceeds | 194,573 | ||
Issuance cost capitalized | 2,456 | $ 6,569 | $ 6,569 |
Threshold amount of single voluntary prepayment from equity proceeds | 50,000 | ||
Threshold annual net sales to be maintained | $ 200,000 | ||
Interest expense | 5,664,000 | 8,650,000 | |
Future minimum payments | |||
2020 | 25,000 | 25,000 | |
2021 | 50,000 | 50,000 | |
2022 | 37,500 | 37,500 | |
2023 | 50,000 | 50,000 | |
2024 | 25,000 | 25,000 | |
Total, Gross | 187,500 | 187,500 | |
Total term notes | $ 180,931 | $ 180,931 | |
Prepayment prior to the second-year anniversary | |||
Debt | |||
Prepayment premium percentage | 3.00% | ||
Prepayment on or after the second-year anniversary, but on or prior to the third-year anniversary | |||
Debt | |||
Prepayment premium percentage | 2.00% | ||
Prepayment on or after the third-year anniversary | |||
Debt | |||
Prepayment premium percentage | 1.00% | ||
Single voluntary prepayment of threshold amount prior to the second-year anniversary | |||
Debt | |||
Prepayment premium percentage | 5.00% | ||
LIBOR | |||
Debt | |||
Floor rate | 2.00% |
Term Notes Payable - Silicon Va
Term Notes Payable - Silicon Valley (Details) - Silicon Valley Bank Term Loan Facility $ in Thousands | 1 Months Ended |
Jan. 31, 2020USD ($) | |
Debt | |
Line of credit | $ 11,500 |
Prime | |
Debt | |
Margin rate | 0.75% |
Convertible Senior Notes - Narr
Convertible Senior Notes - Narrative (Details) $ / shares in Units, $ in Thousands | Feb. 13, 2020USD ($)D$ / shares | Mar. 31, 2020USD ($) | Jun. 30, 2020USD ($)D | Aug. 15, 2020 |
Debt | ||||
Equity component of transaction costs for 2020 Convertible Notes | $ 1,773 | $ 1,773 | $ 1,773 | |
Conversion of convertible debt after the calendar quarter ending on march 31, 2020 | ||||
Debt | ||||
Amortization period of debt discount | 6 years | |||
Convertible senior notes | ||||
Debt | ||||
Interest rate (as a percent) | 2.625% | 2.625% | ||
Aggregate principal amount | $ 143,750 | |||
Total debt issuance cost | 5,473 | |||
Debt discount | $ 3,700 | |||
Amortization period of debt discount | 6 years | |||
Initial conversion rate | 34.2618 | |||
Conversion, threshold percentage of stock price trigger | $ / shares | $ 29.19 | |||
Consecutive business days | D | 5 | |||
Measurement period | D | 10 | |||
Threshold percentage to product of sale price of common stock and conversion rate | 98.00% | |||
Redemption, threshold percentage of stock price trigger | 130.00% | |||
Redemption, threshold trading days | D | 20 | |||
Redemption, threshold consecutive trading days | D | 30 | |||
Default period | 30 days | |||
Threshold amount of money borrowed | $ 20,000 | |||
Initial carrying amount of the Liability Component | 97,200 | |||
Carrying amount of the Equity Component | $ 46,550 | |||
Convertible senior notes | Conversion of convertible debt after the calendar quarter ending on march 31, 2020 | ||||
Debt | ||||
Conversion, threshold percentage of stock price trigger | 130.00% | |||
Conversion, threshold trading days | D | 20 | |||
Conversion, threshold consecutive trading days | D | 30 |
Convertible Senior Notes - Outs
Convertible Senior Notes - Outstanding (Details) - USD ($) $ in Thousands | Feb. 13, 2020 | Mar. 31, 2020 | Jun. 30, 2020 |
Debt | |||
Net carrying amount | $ 96,046 | ||
Equity component of transaction costs for 2020 Convertible Notes | $ 1,773 | $ 1,773 | 1,773 |
Convertible senior notes | |||
Debt | |||
Principal | 143,750 | ||
Less: unamortized debt discount and issuance costs | (47,704) | ||
Net carrying amount | 96,046 | ||
Equity component, net of issuance costs of $1,773 | $ 44,777 | ||
Debt term | 6 years | ||
Effective interest rate | 10.27% |
Convertible Senior Notes - Inte
Convertible Senior Notes - Interest Expenses (Details) - Convertible senior notes - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended |
Jun. 30, 2020 | Jun. 30, 2020 | |
Debt | ||
Contractual interest expense | $ 933 | $ 1,436 |
Amortization of debt discount | 1,540 | 2,359 |
Amortization of debt issuance costs | 122 | 188 |
Total interest expense | $ 2,595 | $ 3,983 |
Convertible Senior Notes - Futu
Convertible Senior Notes - Future Minimum Payments (Details) $ in Thousands | Jun. 30, 2020USD ($) |
Future minimum payments | |
Convertible senior notes | $ 96,046 |
Convertible senior notes | |
Future minimum payments | |
2020 | 1,908 |
2021 | 3,773 |
2022 | 3,773 |
2023 | 3,773 |
2024 | 3,773 |
Thereafter | 149,412 |
Total minimum payments | 166,412 |
Less: interest | (22,662) |
Less: unamortized debt discount and issuance costs | (47,704) |
Convertible senior notes | $ 96,046 |
Equity - Changes in Shareholder
Equity - Changes in Shareholders' Equity (Details) - USD ($) $ in Thousands | Feb. 13, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Jun. 30, 2019 | Mar. 31, 2019 | Jun. 30, 2020 | Jun. 30, 2019 |
Balance at beginning of period | $ 141,063 | $ 87,432 | $ 86,350 | $ 91,585 | $ 87,432 | $ 91,585 | |
Exercise of common stock options | 1,626 | 58 | 246 | 4,454 | |||
Issuance for employee stock purchase plan | 444 | $ 357 | |||||
Issuance for employee stock purchase plan, shares | 39,411 | 32,826 | |||||
Shares withheld for employee taxes upon vesting of RSUs | (564) | (35) | (488) | $ (1,358) | |||
Stock-based compensation | 5,584 | 4,951 | 4,162 | 4,263 | |||
Equity component of 2020 Convertible Notes, net of issuance costs of $1,773 | 44,777 | ||||||
Equity component of transaction costs for 2020 Convertible Notes | $ 1,773 | 1,773 | 1,773 | ||||
Net income (loss) | 8,058 | 450 | (4,712) | (9,700) | 8,508 | $ (14,412) | |
Balance at end of period | 155,767 | 141,063 | 85,823 | 86,350 | 155,767 | 85,823 | |
Common Stock | |||||||
Balance at beginning of period | $ 34 | $ 34 | $ 33 | $ 33 | $ 34 | $ 33 | |
Balance at beginning of year, shares | 34,306,040 | 33,678,840 | 33,385,128 | 33,265,629 | 33,678,840 | 33,265,629 | |
Exercise of common stock options, shares | 131,562 | 8,218 | 18,693 | 455,573 | |||
Issuance for employee stock purchase plan, shares | 32,826 | 39,411 | |||||
Vesting of restricted stock units, shares | 83,461 | 26,304 | 101,483 | 195,280 | |||
Shares withheld for employee taxes upon vesting of RSUs, shares | (26,761) | (3,097) | (33,503) | (63,064) | |||
Balance at end of period | $ 34 | $ 34 | $ 33 | $ 33 | $ 34 | $ 33 | |
Balance at end of year, shares | 34,494,302 | 34,306,040 | 33,416,553 | 33,385,128 | 34,494,302 | 33,416,553 | |
Additional Paid-In Capital | |||||||
Balance at beginning of period | $ 500,478 | $ 447,297 | $ 433,194 | $ 428,729 | $ 447,297 | $ 428,729 | |
Exercise of common stock options | 1,626 | 58 | 246 | 4,454 | |||
Issuance for employee stock purchase plan | 444 | 357 | |||||
Shares withheld for employee taxes upon vesting of RSUs | (564) | (35) | (488) | (1,358) | |||
Stock-based compensation | 5,584 | 4,951 | 4,162 | 4,263 | |||
Equity component of 2020 Convertible Notes, net of issuance costs of $1,773 | 44,777 | ||||||
Balance at end of period | 507,124 | 500,478 | 437,379 | 433,194 | 507,124 | 437,379 | |
Accumulated Deficit | |||||||
Balance at beginning of period | (359,449) | (359,899) | (346,877) | (337,177) | (359,899) | (337,177) | |
Net income (loss) | 8,058 | 450 | (4,712) | (9,700) | |||
Balance at end of period | $ (351,391) | $ (359,449) | $ (351,589) | $ (346,877) | $ (351,391) | $ (351,589) |
Equity (Details)
Equity (Details) - USD ($) $ / shares in Units, $ in Thousands | Jun. 30, 2020 | Nov. 30, 2018 |
Equity | ||
Fair value of warrant | $ 8,043 | |
Third Amendment to the Commercialization Agreement | ||
Equity | ||
Number of shares that can be purchased | 1,041,667 | |
Exercise price of warrant (in dollars per share) | $ 19.20 |
Stock-based Compensation - Summ
Stock-based Compensation - Summary of Stock-Based Compensation Included in Statement of Operations (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Stock-based compensation | ||||
Total stock-based compensation expense | $ 5,584 | $ 4,162 | $ 10,535 | $ 8,425 |
Research and development expenses | ||||
Stock-based compensation | ||||
Total stock-based compensation expense | 984 | 514 | 1,754 | 1,081 |
Selling, general and administrative expenses | ||||
Stock-based compensation | ||||
Total stock-based compensation expense | $ 4,600 | $ 3,648 | $ 8,781 | $ 7,344 |
Stock-based Compensation - Narr
Stock-based Compensation - Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | May 31, 2015 | |
Stock-based compensation | |||||
Unrecognized compensation cost related to outstanding options | $ 44,898 | $ 44,898 | |||
Period over which unrecognized compensation cost is expected to be recognized as expense | 2 years 9 months 18 days | ||||
Employee Stock Purchase Plan, Purchase Price Percentage | 85.00% | ||||
Issuance for employee stock purchase plan, shares | 39,411 | 32,826 | |||
Proceeds from issuances of common stock from employee stock purchase plans | $ 357 | $ 444 | |||
Total purchased proceeds | 92 | $ 73 | 171 | 173 | |
Share-based Compensation | $ 10,535 | $ 8,425 | |||
Weighted-average grant date fair value per share of grants (in dollars per share) | $ 12.83 | $ 9.36 | |||
Total intrinsic value of stock options exercised | $ 7,093 | $ 123 | |||
Stock options | |||||
Stock-based compensation | |||||
Unrecognized compensation cost related to outstanding options | 18,867 | $ 18,867 | |||
Period over which unrecognized compensation cost is expected to be recognized as expense | 2 years 8 months 12 days | ||||
Restricted stock units | |||||
Stock-based compensation | |||||
Period over which unrecognized compensation cost is expected to be recognized as expense | 2 years 10 months 24 days | ||||
Total fair value of shares vested | $ 5,945 | 1,787 | |||
Unrecognized stock-based compensation expense | 21,688 | 21,688 | |||
Fair value of restricted stock units vested | $ 5,008 | ||||
Performance share units | |||||
Stock-based compensation | |||||
Period over which unrecognized compensation cost is expected to be recognized as expense | 2 years 2 months 12 days | ||||
Vesting period | 3 years | ||||
Weighted-average grant date fair value of shares granted | $ 28.81 | ||||
Unrecognized stock-based compensation expense | 4,343 | $ 4,343 | |||
Share-based Compensation | $ 729 | $ 27 | $ 1,126 | $ 42 | |
Performance share units | Minimum | |||||
Stock-based compensation | |||||
Vesting Percentage | 0.00% | ||||
Performance share units | Maximum | |||||
Stock-based compensation | |||||
Vesting Percentage | 200.00% | ||||
2014 Stock Incentive Plan | |||||
Stock-based compensation | |||||
Shares of common stock authorized for issuance (in shares) | 2,700,000 | ||||
Increase in number of authorized shares on the first day of each fiscal year, as a percentage of outstanding common stock (as a percent) | 4.00% | ||||
Shares of common stock remaining available for future grant | 849,731 | 849,731 | |||
Vesting period | 4 years | ||||
Contractual life | 10 years | ||||
2014 Stock Incentive Plan | Minimum | |||||
Stock-based compensation | |||||
Period following termination date vested options are exercisable | 1 month | ||||
2014 Stock Incentive Plan | Maximum | |||||
Stock-based compensation | |||||
Period following termination date vested options are exercisable | 3 months |
Stock-based Compensation - Su_2
Stock-based Compensation - Summary of Restricted Stock and Performance Share Activity (Details) - $ / shares | 6 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | |
Performance share units | ||
Number of shares | ||
Balance | 99,400 | |
Granted | 187,978 | |
Performance adjustment | (4,155) | |
Balance | 283,223 | |
Weighted-average purchase price per share | ||
Balance | $ 15.90 | |
Granted | 28.49 | $ 15.90 |
Performance adjustment | 15.90 | |
Balance | $ 24.26 | |
Restricted stock units | ||
Number of shares | ||
Balance | 849,679 | |
Granted | 762,607 | |
Vested | (278,741) | |
Forfeited | (16,025) | |
Balance | 1,317,520 | |
Weighted-average purchase price per share | ||
Balance | $ 17.10 | |
Granted | 21.37 | $ 15.78 |
Vested | 17.97 | |
Forfeited | 18.87 | |
Balance | $ 19.37 |
Stock-based Compensation - Su_3
Stock-based Compensation - Summary of Stock Option Activity (Details) - Stock options $ / shares in Units, $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2020USD ($)$ / sharesshares | Dec. 31, 2019USD ($)$ / sharesshares | |
Stock option activity | ||
Outstanding | shares | 3,955,887 | |
Granted | shares | 701,249 | |
Exercised | shares | (587,135) | |
Cancelled | shares | (98,551) | |
Outstanding | shares | 3,971,450 | 3,955,887 |
Exercisable at end of period | shares | 2,123,646 | |
Weighted average exercise price per share | ||
Outstanding | $ / shares | $ 16 | |
Granted | $ / shares | 21.39 | |
Exercised | $ / shares | 10.36 | |
Cancelled | $ / shares | 20.69 | |
Outstanding | $ / shares | 17.67 | $ 16 |
Exercisable at end of period | $ / shares | $ 16.95 | |
Stock option activity, additional information | ||
Outstanding Weighted-Average Remaining Contractual Term | 7 years 8 months 12 days | 7 years 6 months |
Outstanding Aggregate Intrinsic Value | $ | $ 7,866 | $ 21,257 |
Exercisable at end of period, Weighted-Average Remaining Contractual Term | 6 years 8 months 12 days | |
Exercisable at end of period, Aggregate Intrinsic Value | $ | $ 5,058 |
Stock-based Compensation - Su_4
Stock-based Compensation - Summary of Valuation Assumptions Used (Details) | 6 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | |
Weighted-average assumptions used in the Black-Scholes option pricing model to determine the fair value of the employee stock option grants | ||
Risk-free interest rate | 1.30% | 2.60% |
Volatility | 66.10% | 63.30% |
Expected term (in years) | 6 years 1 month 6 days | 6 years 1 month 6 days |
Commitments and Contingencies (
Commitments and Contingencies (Details) | Nov. 06, 2019lawsuit | Oct. 18, 2019lawsuit | Sep. 11, 2019item | May 09, 2019patent | Sep. 26, 2018lawsuit | Jul. 12, 2018lawsuit | May 04, 2018lawsuit | Feb. 22, 2018patent | Mar. 24, 2015patent | Oct. 31, 2019lawsuit | Mar. 31, 2019itemlawsuit | Nov. 30, 2018patent | Jun. 30, 2020lawsuitpatent |
Commitments and Contingencies | |||||||||||||
Period that gives the Company a 30-month stay of FDA approval while the parties have an opportunity to litigate | 45 days | ||||||||||||
Stay period before FDA can issue a final approval unless it is terminated | 30 months | ||||||||||||
Number of lawsuits filed | 2 | 4 | 2 | ||||||||||
Purdue Pharma, L. P. patent infringement suits | |||||||||||||
Commitments and Contingencies | |||||||||||||
PTAB duration for issuing decision | 1 year | ||||||||||||
Purdue Pharma, L. P. patent infringement suits | Maximum | |||||||||||||
Commitments and Contingencies | |||||||||||||
PTAB extended duration for issuing decision | 6 months | ||||||||||||
Purdue Pharma, L. P. patent infringement suit, District of Delaware | |||||||||||||
Commitments and Contingencies | |||||||||||||
Number of patents allegedly infringed | patent | 3 | 5 | |||||||||||
Purdue Pharma, L. P. patent infringement suit, District of Massachusetts | |||||||||||||
Commitments and Contingencies | |||||||||||||
Number of patents allegedly infringed | patent | 5 | ||||||||||||
Number of patents found not infringed | patent | 3 | ||||||||||||
Number of suits that are associated with any 30-month stay of FDA approval | 0 | ||||||||||||
Teva Litigation | |||||||||||||
Commitments and Contingencies | |||||||||||||
Stay period before FDA can issue a final approval unless it is terminated | 30 months | ||||||||||||
Number of patents allegedly infringed | patent | 1 | 2 | 11 | ||||||||||
Number of patents found not infringed | patent | 11 | ||||||||||||
Number of patents listed in FDA Orange Book | patent | 15 | ||||||||||||
Number of terms or sets of terms addressed | item | 2 | ||||||||||||
Number of terms or sets of terms in dispute | item | 6 | ||||||||||||
Opioid Litigation | |||||||||||||
Commitments and Contingencies | |||||||||||||
Number of counties filed lawsuits | 3 | ||||||||||||
Number of lawsuits filed | 3 | 2 | |||||||||||
Number of lawsuits currently stayed | 0 | ||||||||||||
Number of lawsuits dismissed | 4 | ||||||||||||
Payor Groups and Warminster Township | |||||||||||||
Commitments and Contingencies | |||||||||||||
Number of lawsuits filed | 3 | ||||||||||||
Number of lawsuits currently stayed | 0 | ||||||||||||
Number of payor groups | item | 2 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Income Taxes | ||||
Provision for income taxes | $ 246 | $ 246 | ||
Effective tax rate | 3.00% | 0.00% | 2.80% | 0.00% |
Current federal income tax expense | $ 0 |