Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2018 | Apr. 30, 2018 | |
Document and Entity Information | ||
Entity Registrant Name | COLLEGIUM PHARMACEUTICAL, INC | |
Entity Central Index Key | 1,267,565 | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2018 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 33,044,050 | |
Document Fiscal Year Focus | 2,018 | |
Document Fiscal Period Focus | Q1 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Current assets | ||
Cash and cash equivalents | $ 128,249 | $ 118,697 |
Accounts receivable | 66,036 | 9,969 |
Inventory | 7,902 | 1,813 |
Prepaid expenses and other current assets | 5,526 | 3,005 |
Total current assets | 207,713 | 133,484 |
Property and equipment, net | 1,612 | 1,826 |
Intangible assets, net | 486,100 | |
Restricted cash | 703 | 97 |
Other long-term assets | 150 | 161 |
Total assets | 696,278 | 135,568 |
Current liabilities | ||
Accounts payable | 9,336 | 5,684 |
Accrued expenses | 17,436 | 8,541 |
Accrued rebates, returns and discounts | 92,400 | 15,784 |
Current portion of asset acquisition obligations | 131,056 | |
Current portion of term loan payable | 1,479 | |
Total current liabilities | 250,228 | 31,488 |
Asset acquisition obligations, long-term | 343,727 | |
Term loan payable, long-term | 11,500 | |
Total liabilities | 605,455 | 31,488 |
Commitments and contingencies (see Note 12) | ||
Shareholders' equity: | ||
Preferred stock, $0.001 par value; authorized shares - 5,000,000 at March 31, 2018 and December 31, 2017; issued and outstanding shares - none at March 31, 2018 and December 31, 2017 | ||
Common stock, $0.001 par value; authorized shares - 100,000,000 at March 31, 2018 and December 31, 2017; issued and outstanding shares - 33,027,579 at March 31, 2018 and 32,770,678 at December 31, 2017 | 33 | 33 |
Additional paid-in capital | 407,491 | 402,096 |
Accumulated deficit | (316,701) | (298,049) |
Total shareholders' equity | 90,823 | 104,080 |
Total liabilities and shareholders' equity | $ 696,278 | $ 135,568 |
CONDENSED CONSOLIDATED BALANCE3
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Mar. 31, 2018 | Dec. 31, 2017 |
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 | 33,027,579 | 32,770,678 |
Common stock, outstanding shares | 33,027,579 | 32,770,678 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Revenues | ||
Product revenues, net | $ 63,749 | $ 2,172 |
Costs and expenses | ||
Cost of product revenues | 43,106 | 371 |
Research and development | 2,268 | 2,130 |
Selling, general and administrative | 31,582 | 22,847 |
Total costs and expenses | 76,956 | 25,348 |
Loss from operations | (13,207) | (23,176) |
Interest expense | (5,700) | |
Interest income | 255 | 98 |
Net loss | $ (18,652) | $ (23,078) |
Loss per share - basic and diluted | $ (0.57) | $ (0.79) |
Weighted-average shares - basic and diluted | 32,903,674 | 29,350,268 |
CONDENSED CONSOLIDATED STATEME5
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Operating activities | ||
Net loss | $ (18,652) | $ (23,078) |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | ||
Depreciation expense | 482 | 208 |
Amortization expense | 29,526 | |
Lease incentive obligation | (9) | |
Stock-based compensation expense | 2,728 | 1,821 |
Non-cash interest expense | 5,528 | |
Changes in operating assets and liabilities: | ||
Accounts receivable | (56,067) | (1,220) |
Inventories | 134 | (179) |
Prepaid expenses and other assets | (523) | (148) |
Accounts payable | 3,652 | (2,313) |
Accrued expenses | 8,900 | (2,521) |
Accrued rebates, returns and discounts | 53,955 | |
Deferred revenue | 3,751 | |
Net cash provided by (used in) operating activities | 29,663 | (23,688) |
Investing activities | ||
Cash paid for asset acquisition | (18,761) | |
Purchases of property and equipment | (356) | (29) |
Net cash used in investing activities | (19,117) | (29) |
Financing activities | ||
Cash paid for common stock offerings costs | (30) | |
Proceeds from issuances of common stock from employee stock purchase plans | 510 | 673 |
Proceeds from term loan amendment, net of repayment of amended term loan | 10,020 | |
Repayment of asset acquisition obligations | (13,045) | |
Repayment of term note | (666) | |
Proceeds from the exercise of stock options | 2,373 | 94 |
Payments made for employee restricted stock tax withholdings | (216) | (51) |
Net cash (used in) provided by financing activities | (388) | 50 |
Net increase (decrease) in cash, cash equivalents and restricted cash | 10,158 | (23,667) |
Cash, cash equivalents and restricted cash at beginning of period | 118,794 | 153,322 |
Cash, and cash equivalents and restricted cash at end of period | 128,952 | 129,655 |
Supplemental disclosure of cash flow information | ||
Cash paid for offering costs | 30 | |
Cash paid for interest | 109 | 49 |
Supplemental disclosure of non-cash activities | ||
Offering costs in accrued expenses | 25 | 112 |
Acquisition of property and equipment in accrued expenses | 129 | $ 99 |
Asset acquisition transaction costs in accrued expenses | 116 | |
Liabilities assumed from asset acquisition in accrued rebates, returns and discounts | $ 22,660 |
Nature of Business
Nature of Business | 3 Months Ended |
Mar. 31, 2018 | |
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 Canton, Massachusetts. The Company is a specialty pharmaceutical company focused on becoming the leader in responsible pain management by developing and commercializing innovative, differentiated products for patients suffering from pain . The Company’s first product, Xtampza ER®, or Xtampza, is an abuse-deterrent, extended-release, oral formulation of oxycodone, a widely prescribed opioid medication. In April 2016, the U.S. Food and Drug Administration (“FDA”) approved the Company’s new drug application (“NDA”) filing for Xtampza 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. In December 2017, the Company and its wholly owned subsidiary, Collegium NF, LLC (“Collegium NF”) entered into a Commercialization Agreement with Depomed, Inc. (“Depomed”), pursuant to which Depomed agreed to grant a sublicense of certain of its intellectual property related to Nucynta ER and IR products (the “Nucynta Products”) to the Company for commercialization of the Nucynta Products in the United States. On January 9, 2018, the parties amended the Commercialization Agreement (as amended, the “Commercialization Agreement”) and consummated the transactions contemplated thereby. 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 moderate to severe acute pain in adults. The Company began shipping and recognizing product sales on the Nucynta Products on January 9, 2018 and began commercial promotion of the Nucynta Products in February 2018. The assets and liabilities assumed by the Company in connection with the Commercialization Agreement are further described in Note 7. 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 product candidates (including development of competing products), changing regulatory environment and reimbursement landscape, negative outcome of clinical trials, inability or delay in completing clinical trials or obtaining regulatory approvals, key personnel retention and protection of intellectual property, patent infringement litigation and the availability of additional capital financing on terms acceptable to the Company. The Company has experienced net losses and negative cash flows from operating activities since its inception, and, as of March 31, 2018 had an accumulated deficit of $316,701. The Company expects to continue to incur net losses in the near future. A successful transition to profitable operations is dependent upon achieving a level of revenues adequate to support the Company’s cost structure. The Company believes that its cash and cash equivalents at March 31, 2018, 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 into 2020 . The Company may never achieve profitability, and unless and until it does, the Company will continue to need to raise additional cash. Management intends to fund future operations through additional private or public debt or equity offerings and may seek additional capital through arrangements with strategic partners or from other sources. If the Company is unable to obtain financing or increase profitability, the related lack of liquidity will have a material adverse effect on the Company’s operations and future prospects. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2018 | |
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 financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States (“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 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 March 31, 2018, the results of operations for three months ended March 31, 2018 and 2017 , and cash flows for the three months ended March 31, 2018 and 2017. The results of operations for the three months ended March 31, 2018 are not necessarily indicative of the results to be expected for the full year. When preparing financial statements in conformity with GAAP, the Company must make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in the Company’s financial statements and accompanying notes. The most significant estimates in the Company’s financial statements relate to revenue recognition, including the estimates of product returns, units prescribed, discounts and allowances related to commercial sales of its products, estimates utilized in the valuation of inventory, estimates of useful lives with respect to intangible assets, accounting for stock-based compensation, contingencies, 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 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. 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. Controlled Equity Offering Sales Agreement In March 2017, the Company entered into a Controlled Equity Offering Sales Agreement (the “ATM Sales Agreement”), with Cantor Fitzgerald & Co., as sales agent (“Cantor Fitzgerald”), pursuant to which the Company may issue and sell, from time to time, through Cantor Fitzgerald, shares of the Company’s common stock, up to an aggregate offering price of $60,000 (the “ATM Shares”). Under the ATM Sales Agreement, Cantor Fitzgerald may sell the ATM Shares by methods deemed to be an “at-the-market” offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended (the “Securities Act”), including sales made directly on The NASDAQ Global Select Market, on any other existing trading market for the ATM Shares or to or through a market maker. In addition, under the ATM Sales Agreement, Cantor Fitzgerald may sell the ATM Shares by any other method permitted by law, including in privately negotiated transactions. The Company is not obligated to make any sales of the ATM Shares under the ATM Sales Agreement. The Company or Cantor Fitzgerald may suspend or terminate the offering of ATM Shares upon notice to the other party and subject to other conditions. The Company will pay Cantor Fitzgerald a commission of up to 3.0% of the gross proceeds from the sale of the ATM Shares pursuant to the ATM Sales Agreement and has agreed to provide Cantor Fitzgerald with customary indemnification and contribution rights. As of March 31, 2018, the Company had sold an aggregate of 3,126,998 shares at an average gross sales price of $11.36 per share generating net proceeds of $34,283, after deduction of underwriting discounts and commissions and expenses payable by the Company. All shares sold pursuant to the ATM Sales agreement were sold during the year ended December 31, 2017. The Company did not sell any shares pursuant to the ATM sales agreement during the three months ended March 31, 2018. Advertising and Product Promotion Costs Advertising and product promotion costs are included in selling, general and administrative expenses and were $2,562 and $3,860 in the three months ended March 31, 2018 and 2017 respectively. Advertising and product promotion costs are expensed as incurred. Restricted Cash Restricted cash represents cash held in a depository account at a financial institution to collateralize a conditional stand‑by letter of credit related to the Company’s facility lease agreements. Restricted cash is reported as non‑current unless the restrictions are expected to be released in the next twelve months. Leases Effective March 2018, the Company entered into a lease for its new corporate headquarters (the “Lease”) pursuant to which the Company will lease approximately 50,678 of rentable square feet of space, in Stoughton, Massachusetts. The Lease will commence when the tenant improvements in the space are substantially complete and will continue thereafter for a term of ten years. The Company has the right to extend the term of the Lease for two additional five-year terms, provided that written notice is provided to the Landlord no later than twelve months prior to the expiration of the current Lease term. The initial annual base rent is $1,214, or $23.95 per rentable square foot, and will increase annually by 2.5% to 3.1% over the subsequent Lease years. The Company is still evaluating when it plans to take possession of the new space and when the Lease term will commence. Income Taxes For the three months ended March 31, 2018 and 2017, the Company did not record a current or deferred income tax expense or (benefit) due to current and historical losses incurred by the Company. The Company's losses before income taxes consist solely of losses from domestic operations. As of March 31, 2018, the Company has recorded a full valuation allowance for deferred tax assets including NOL and tax credit carryovers. The Tax Cuts and Jobs Act of 2017 (“TCJA” or “2017 Tax Act”), which was signed into law in December 2017, has resulted in significant changes to the U.S. corporate income tax system. The SEC staff issued Staff Accounting Bulletin (SAB) 118, which provides guidance on accounting for enactment effects of the TCJA. The Company has not finalized its review of the impact of TCJA on the NOL rules, and the impact, if any, to the Company’s ability to utilize and carryover net operating losses. For additional information related to the TCJA, please read Note 13, Income Taxes, to our consolidated financial statements included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2017. 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. In May 2014, the FASB issued Accounting Standards Update, or ASU, 2014-09, Revenue from Contracts with Customers (Topic 606) , which amends the guidance for accounting for revenue from contracts with customers. This ASU supersedes the revenue recognition requirements in ASC Topic 605, Revenue Recognition , and creates a new Topic 606, Revenue from Contracts with Customers . In 2015, 2016 and 2017, the FASB issued additional ASUs related to Topic 606, including ASUs 2015-14, 2016-08, 2016-10, 2016-12, 2016-20, 2017-13, 2017-14, that delayed the effective date of and clarified various aspects of the new guidance, including principal versus agent considerations, identifying performance obligations, and licensing. The Company adopted ASC Topic 606, Revenue from Contracts with Customers , on January 1, 2018 using the modified retrospective method for all contracts not completed as of the date of adoption. The adoption of ASU 2014-09 did not have an impact on the Company’s consolidated financial position, results of operations, equity or cash flows as of the adoption date or for the three months ended March 31, 2018. Refer to Note 3 "Revenue from Contracts with Customers" for the required disclosures and a discussion of the Company's policies related to revenue recognition. In August 2016, the FASB issued ASU 2016-15, Classification of Certain Cash Receipts and Cash Payments , and in November 2016, the FASB issued ASU 2016-18, Restricted Cash . The purpose of ASU 2016-15 is to reduce the diversity in presentation and classification of the following items within the Statement of Cash Flows: debt prepayments, settlement of zero coupon debt instruments, contingent consideration payments, insurance proceeds, securitization transactions and distributions from equity method investees. The update also addresses classification of transactions that have characteristics of more than one class of cash flows. ASU 2016-18 requires the Statement of Cash Flows to explain the change during the period in the total of cash, cash equivalents, and amounts generally described as restricted cash or restricted cash equivalents. Therefore, amounts generally described as restricted cash and restricted cash equivalents should be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the Statement of Cash Flows. The Company adopted these new standards on January 1, 2018 using the retrospective transition method as required with respect to each period presented. The adoption of these standards did not have an impact on the Company’s consolidated financial statements. Recently Issued Accounting Pronouncements Not Yet Adopted In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) . ASU 2016-02 most significantly impacts lessee accounting and disclosures. First, this guidance requires lessees to identify arrangements that should be accounted for as leases. Under ASU 2016-02, for lease arrangements exceeding a 12-month term, a right-of-use asset and lease obligation is recorded by the lessee for all leases, whether operating or financing, while the income statement will reflect lease expense for operating leases and amortization/interest expense for financing leases. The Balance Sheet amount recorded for existing leases at the date of adoption of ASU 2016-02 must be calculated using the applicable incremental borrowing rate at the date of adoption. Leases with a term of 12 months or less will be accounted for in a manner similar to existing guidance for operating leases. In addition, ASU 2016-02 requires the use of the modified retrospective method, which will require adjustment to all comparative periods presented in the consolidated financial statements. This guidance is effective for public companies for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018. Early adoption is permitted for all entities. The Company has not chosen early adoption for this ASU and is currently evaluating its effect on the Company’s consolidated financial statements. Based on its preliminary assessment, the Company expects to recognize a right-to-use asset and corresponding lease liability on its Balance Sheet related to lease agreement for its corporate headquarters upon adoption of this ASU. |
Revenue from Contracts with Cus
Revenue from Contracts with Customers | 3 Months Ended |
Mar. 31, 2018 | |
Revenue from Contracts with Customers | |
Revenue from Contract with Customer | 3. Revenue from Contracts with Customers The Company’s only source of revenue to date has been generated by sales of the Company’s products, which are primarily sold to distributors and retailers (“customers”), which in turn sell the product to pharmacies for the treatment of patients (“end users”). Revenue Recognition In accordance with ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”), the Company recognizes revenue when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Adoption of ASC Topic 606, Revenue from Contracts with Customers The Company adopted ASC 606 on January 1, 2018 using the modified retrospective method. Under this method, prior periods were not retrospectively adjusted and, as a result, the reported results for 2018 reflect the application of ASC 606 guidance while the reported results for 2017 were prepared under the guidance of ASC Topic 605, Revenue Recognition (“legacy GAAP”). Immediately prior to the adoption date of January 1, 2018, the Company recognized revenue in accordance with legacy GAAP, or when there was persuasive evidence of an arrangement; title and risk of loss had passed to the customer; when estimated provisions for chargebacks, rebates, sales incentives and allowances, distribution service fees, and returns were reasonably determinable; and when collectability was reasonably assured. The satisfaction of these criteria generally occurred upon delivery of products to customers, or the sell-in method of revenue recognition under legacy GAAP. The Company began recognizing revenue on the sell-in method in the third quarter of 2017. Prior to the third quarter of 2017, the Company recognized revenue when products were dispensed to end users, or the sell-through method of revenue recognition under legacy GAAP, as the Company did not have sufficient experience with product sales to estimate returns at the time product was sold to customers. As a result of the considerations discussed above, the Company concluded that, as of the adoption date, it would record revenue net of a provision for estimated chargebacks, rebates, sales incentives and allowances, distribution service fees, and returns upon delivery of products to customers under either the sell-in method of revenue recognition under legacy GAAP or under Topic 606 as of the adoption date. Therefore, the adoption of Topic 606 did not have a material impact on the Company’s consolidated financial position, results of operations, equity or cash flows as of January 1, 2018, however, periods presented prior to the third quarter of 2017, when the Company recognized revenue on the sell-through method under legacy GAAP, would be impacted. For the three months ended March 31, 2017, the Company determined that, under Topic 606, the only significant changes to the reported results for the three months ended March 31, 2017 under Topic 606 would be higher product sales of $1,220 due to the acceleration of revenue recognition for product sales in which recognition was previously deferred due to the fees not being fixed or determinable under the sell-through method under legacy GAAP. Performance Obligations The Company determined that performance obligations are satisfied and 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 chargebacks, rebates, sales incentives and allowances, distribution service fees, and returns. The Company will estimate the amount of variable consideration that should be included in the transaction price under the expected value method. T hese estimates take into consideration a range of possible outcomes that are probability-weighted for relevant factors such as the Company’s historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. These provisions reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the contract. 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 table summarizes activity in each of the Company’s product revenue provision and allowance categories for the three months ended March 31, 2018: Rebates and Product Trade Allowances and Incentives (1) Returns (2) Chargebacks (3) Balance at December 31, 2017 $ 12,647 $ 3,137 $ 2,256 Provision related to current period sales 58,591 4,047 16,650 Changes in estimate related to prior period sales (32) - - Credits/payments made (7,842) (809) (4,253) Balance at March 31, 2018 $ 63,364 $ 6,375 $ 14,653 (1) Rebates and discounts includes managed care rebates, government rebates, co-pay program incentives, and sales incentives and allowances. Provisions for rebates and discounts 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. (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) Trade allowances and chargebacks includes 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. In addition to the above, the Company also recorded a liability of $22,660, representing the assumed rebate liabilities relating to sales of Nucynta Products that occurred prior to the closing date of January 9, 2018 which the Company is liable for under the terms of the Commercialization Agreement. This assumed liability is included as a component of the intangible asset acquired and as a component of accrued rebates, returns and discounts as of March 31, 2018 in the Company’s Condensed Consolidated Balance Sheets. As of March 31, 2018, 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 Product revenues, net consisted of the following: Three Months Ended March 31, 2018 2017 Xtampza $ 15,795 $ 2,172 Nucynta 47,954 — Total product revenues, net $ 63,749 $ 2,172 |
Loss per Common Share
Loss per Common Share | 3 Months Ended |
Mar. 31, 2018 | |
Loss per Common Share | |
Loss per Common Share | 4. Loss per Common Share The following table presents the computations of basic and dilutive net loss per share: Three months ended March 31, 2018 2017 Loss attributable to common shareholders — basic and diluted $ (18,652) $ (23,078) Weighted-average number of common shares used in net loss per share - basic and diluted 32,903,674 29,350,268 Loss per share - basic and diluted $ (0.57) $ (0.79) The following potentially dilutive securities, which represent all outstanding potentially dilutive securities, were excluded from the calculation of diluted net loss per share due to their anti-dilutive effect (in common stock equivalent shares): Three months ended March 31, 2018 2017 Outstanding stock options 3,592,233 2,835,630 Warrants 2,445 2,445 Unvested restricted stock (1) 19,303 69,870 Restricted stock units 497,686 153,361 (1) - Includes shares of unvested restricted stock remaining from the early exercise of stock options. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 3 Months Ended |
Mar. 31, 2018 | |
Fair Value of Financial Instruments | |
Fair Value of Financial Instruments | 5. Fair Value of Financial Instruments Disclosures of fair value information about financial instruments are required, whether recognized in the Balance Sheet or not, 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 The following tables present the Company’s financial instruments carried at fair value using the lowest level input applicable to each financial instrument at March 31, 2018 and December 31, 2017. Significant Quoted Prices other Significant in active observable unobservable markets inputs inputs March 31, 2018 Total (Level 1) (Level 2) (Level 3) Money market funds, included in cash equivalents $ 81,479 $ 81,479 $ — $ — December 31, 2017 Money market funds, included in cash equivalents $ 81,225 $ 81,225 $ — $ — The Company’s cash equivalents are comprised of money market funds that are measured on a recurring basis based on quoted market prices. As of March 31, 2018 and December 31, 2017 the carrying amounts of cash and cash equivalents, accounts receivable, prepaid expenses, inventory, intangible assets, accounts payable, accrued expenses, accrued rebates, returns and discounts, and term loan payable approximated their estimated fair values. In connection with the Commercialization Agreement for the Nucynta Products, the Company recorded a liability of $482,300 representing the fair value of the future minimum royalty payments owed under the terms of the Commercialization Agreement. The fair value of the minimum royalty payments was measured by calculating the present value of the minimum royalty payments using a discount rate of 5.7%. The discount rate is a Level 2 input which was based on a review of observable market data of similar liabilities. The liability associated with the future minimum royalty payments is included as a component of the intangible asset acquired and as a component of the obligations assumed in connection with the Commercialization Agreement, which is further described in Note 7. As of March 31, 2018, the carrying amounts of the a sset acquisition obligations approximated its estimated fair value. |
Inventory
Inventory | 3 Months Ended |
Mar. 31, 2018 | |
Inventory | |
Inventory | 6. Inventory Inventory consisted of the following: As of March 31, As of December 31, 2018 2017 Raw materials $ 532 $ 616 Work in process 496 322 Finished goods 6,874 875 Total inventory $ 7,902 $ 1,813 The aggregate charges related to excess inventory for both the March 31, 2018 and 2017 were immaterial. These expenses were recorded as a component of cost of product revenues. |
Intangible Assets and Asset Acq
Intangible Assets and Asset Acquisition Obligations | 3 Months Ended |
Mar. 31, 2018 | |
Intangible Assets and Asset Acquisition Obligations | |
Intangible Assets and Asset Acquisition Obligations | 7. Intangible Assets and Asset Acquisition Obligations As of March 31, 2018, the Company’s only intangible asset related to the Company’s Commercialization Agreement with Depomed, pursuant to which Depomed agreed to grant a sublicense of certain of its intellectual property related to the Nucynta Products to the Company for commercialization of the Nucynta Products in the United States (the “Nucynta Intangible Asset”). The Company closed the transactions contemplated by the Commercialization Agreement, as amended, on January 9, 2018, and began marketing the Nucynta Products in February 2018. Nucynta Intangible Asset The Company determined that the Commercialization Agreement represented an asset acquisition, as substantially all of the fair value of the gross assets acquired is concentrated in the sublicense of the Nucynta Products, which is a single identifiable asset or group. The consideration transferred in the asset acquisition was measured at cost, including transaction costs, assets transferred by the acquirer, and liabilities assumed by the acquirer. The transaction resulted in the Company receiving the assets and assuming the liabilities noted below, which were recognized at cost as a component of intangible assets in the Company’s Condensed Consolidated Balance Sheets during the three months ended March 31, 2018: Upfront cash paid for Nucynta asset acquisition $ 18,877 Identifiable assets acquired and liabilities assumed: Intangible assets $ 515,627 Inventory 6,223 Prepaid expenses 1,987 Minimum royalty payments (482,300) Other liabilities (22,660) Total $ 18,877 The Company will amortize the intangible asset relating to the Commercialization Agreement 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 determined that the useful life for the intangible asset is approximately 4.0 years from the closing date of January 9, 2018. The Company will recognize amortization expense as cost of product revenues in the Statement of Operations on a straight-line basis over its useful life as it approximates cash flows. For the three months ended March 31, 2018, the Company recognized amortization expense of $29,526. As of March 31, 2018, the remaining amortization period is approximately 3.8 years and estimated amortization for the remainder of 2018, 2019, 2020, and 2021 is expected to be $97,219, $129,627, $129,627, and $129,627, respectively. As of March 31, 2018, the gross carrying amount and accumulated amortization of the Nucynta intangible were as follows: As of March 31, 2018 Gross carrying amount $ 515,626 Accumulated amortization (29,526) Intangible assets, net $ 486,100 Nucynta Asset Acquisition Obligations From January 9, 2018 through December 2021, under the terms of the Commercialization Agreement, the Company will be required to pay a minimum royalty of $135,000 per year, payable in quarterly payments of $33,750, prorated in 2018 for the closing date of January 9, 2018. The total required minimum royalty payment from the closing date of January 9, 2018 through December 2021 is $537,000. Payments are swept to Depomed daily based on proceeds received for Nucynta Product sales, and minimum payments are paid in full within 45 days of the quarter end. Due to the nature of the obligation and fact that it will be settled in cash, the Company determined that the minimum royalty payments represented a liability incurred at the closing of the transaction and that the liability should be recorded at its fair value as of the closing date on the Company’s Condensed Consolidated Balance Sheet. The Company calculated the fair value of the minimum royalty payments to be $482,300, which was the calculated present value of the minimum royalty payments using a discount rate of 5.7%. The discount rate was determined based on a review of observable market data of similar liabilities. The Company will recognize the $54,700 discount as interest expense in the Statement of Operations using the effective interest method and will recognize the interest over the repayment period from January 9, 2018 through December 2021. For the three months ended March 31, 2018, the Company recognized interest expense of $5,528 relating to the minimum royalty payments. As of March 31, 2018, the remaining estimated interest expense relating to the minimum royalty payments for the remainder of 2018, 2019, 2020, and 2021 is expected to be $16,855, $17,138, $10,907, and $4,272, respectively. For the three months ended March 31, 2018, the prorated minimum royalty payment of $30,750 became due and payable. As of March 31, 2018, the Company paid $13,045 in royalty payments and the remaining $17,705 of the minimum royalty payment will be paid within 45 days of March 31, 2018. As of March 31, 2018, the remaining minimum royalty payments due under the Commercialization Agreement are as follows: 2018 $ 118,955 2019 135,000 2020 135,000 2021 135,000 Total remaining minimum royalty payments due $ 523,955 Less: Unamortized discount (49,172) Carrying value of minimum royalty payments $ 474,783 Onsolis Intangible Asset In May 2016, the Company entered into an agreement with BioDelivery Sciences International, Inc. (“BDSI”) to license the rights to develop, manufacture, and commercialize Onsolis® (fentanyl buccal soluble film), or Onsolis, in the United States. Onsolis is a Transmucosal Immediate-Release Fentanyl (“TIRF”) film indicated for the management of breakthrough pain in certain cancer patients. During the year ended December 31, 2016, the Company made an upfront payment of $2,500 and recorded the payment as a component of intangible assets. On December 8, 2017, the Company, after a review of its product portfolio, provided written notice to BDSI of termination of the License and Development Agreement. The termination was effective pursuant to the terms of such agreement on March 8, 2018. Upon such termination of the License Agreement, the Company’s rights to develop and commercialize Onsolis reverted to BDSI. As a result of this notice of termination, the Company determined that the carrying amount of the intangible asset was not recoverable and that the carrying amount exceeded its fair value. As such, an impairment loss of $1,845 was recognized and included as a component of sales, general and administrative expense during the year ended December 31, 2017 and the net intangible asset is zero as of March 31, 2018 and December 31, 2017. During the three months ended March 31, 2018 and 2017, the Company recognized amortization expense of zero and $130, respectively. Amortization Expense Amortization expense relating to the Company’s intangible assets for the three months ended March 31, 2018 and 2017 was as follows: March 31, March 31, 2018 2017 Nucynta amortization expense included in cost of product revenues $ 29,526 $ - Onsolis amortization expense included in selling, general and administrative expense - 130 Total amortization expense $ 29,526 $ 130 |
Accrued Expenses
Accrued Expenses | 3 Months Ended |
Mar. 31, 2018 | |
Accrued Expenses | |
Accrued Expenses | 8. Accrued Expenses Accrued expenses consisted of the following: As of March 31, As of December 31, 2018 2017 Accrued cost of product revenues $ 6,710 $ — Accrued incentive compensation 2,937 1,790 Accrued inventory 2,367 — Accrued payroll and related benefits 1,579 1,382 Accrued other operating costs 1,453 877 Accrued bonuses 883 2,940 Accrued sales and marketing 719 624 Accrued audit and legal 554 405 Accrued development costs 136 517 Accrued interest 98 6 Total accrued expenses $ 17,436 $ 8,541 |
Term Loan Payable
Term Loan Payable | 3 Months Ended |
Mar. 31, 2018 | |
Term Loan Payable | |
Term Loan Payable | 9. Term Loan Payable On August 28, 2012, the Company entered into a loan agreement (“Original Term Loan”) with Silicon Valley Bank (“SVB”) to borrow up to a maximum amount of $1,000. The Original Term Loan bore interest at a rate per annum of 2.25% above the prime rate fixed at the time of advance of the Original Term Loan (5.50%). The Original Term Loan was subsequently amended in 2014 and 2015 to provide for additional borrowings of up to $8,000, adjust the interest rate, extend the loan draw period, and modify loan covenants (as amended, the “Existing Term Loan”). As of December 31, 2017, the future payments under the Existing Term Loan were $1,479. In connection with, and as a condition to, consummation of the transactions contemplated by the Commercialization Agreement with Depomed, the Company entered into a Consent and Amendment to Loan and Security Agreement (the “Consent and Amendment”) with SVB to amend the Existing Term Loan. The Consent and Amendment provided the Company with a new term loan facility in an original principal amount of $11,500 (the “New Term Loan”), which replaced the Existing Term Loan and the proceeds of which were used by the Company to finance certain payment obligations under the Commercialization Agreement and to repay the balance of the Existing Term Loan. The Consent and Amendment also provided SVB’s consent with respect to transactions contemplated by the Commercialization Agreement, including the delivery by SVB of a standby letter of credit in an aggregate amount of $33,750. The New Term Loan bears interest at a rate per annum of 0.75% above the prime rate (as defined in the Consent and Amendment). The Company will repay the New Term Loan in equal consecutive monthly installments of principal plus monthly payments of accrued interest, commencing in July 2019, provided that, if the Company achieves EBITDA (as defined in the Consent and Amendment) in excess of $2,500 for two (2) consecutive calendar quarters prior to June 2019, such payments will commence in January 2020. All outstanding principal and accrued and unpaid interest under the New Term Loan, and all other outstanding obligations with respect to the New Term Loan, are due and payable in full in December 2022. The Company may prepay the New Term Loan, in full but not in part, with a prepayment fee of (i) 3.0% of the outstanding principal balance prior to the first anniversary of the Consent and Amendment, (ii) 2.0% of the outstanding principal balance following the first anniversary of the Consent and Amendment and prior to the second anniversary of the Consent and Amendment and (iii) 1.0% of the outstanding principal balance following the second anniversary of the Consent and Amendment, plus, in each case, a final payment fee of $719. The New Term Loan was further amended on March 30, 2018, extending the required refinancing date to August 1, 2018. Under the New Term Loan, the Company will be required to maintain a liquidity ratio of at least 2.0 to 1.0. Any amounts outstanding during the continuance of any event of default under the New Term Loan will bear additional interest at the per annum rate of 5.0%. As of March 31, 2018, scheduled principle repayments under the Company’s term loan are as follows: 2018 $ — 2019 1,642 2020 3,286 2021 3,286 2022 3,286 Balance $ 11,500 |
Equity
Equity | 3 Months Ended |
Mar. 31, 2018 | |
Equity | |
Equity | 10. Equity The changes in shareholders’ equity for the three months ended March 31, 2018 were as follows: Additional Total Common Stock Paid- In Accumulated Shareholders’ Shares Amount Capital Deficit Equity (Deficit) Balance, December 31, 2017 32,770,678 $ 33 $ 402,096 $ (298,049) $ 104,080 Exercise of common stock options 183,987 — 2,373 — 2,373 Issuance for employee stock purchase plan 50,151 — 510 — 510 Vesting of restricted stock units 32,573 — — — — Shares withheld for employee taxes upon vesting of restricted stock units (9,810) — (216) — (216) Stock-based compensation — — 2,728 — 2,728 Net loss — — — (18,652) (18,652) Balance, March 31, 2018 33,027,579 $ 33 $ 407,491 $ (316,701) $ 90,823 |
Stock-based Compensation
Stock-based Compensation | 3 Months Ended |
Mar. 31, 2018 | |
Stock-based Compensation | |
Stock-based Compensation | 11. 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 March 31, 2018 2017 Research and development expenses $ 324 $ 209 Selling, general and administrative expenses 2,404 1,612 Total stock-based compensation expense $ 2,728 $ 1,821 At March 31, 2018, there was approximately $33,065 of unrecognized compensation expense related to unvested options, restricted stock units and restricted stock awards, which is expected to be recognized as expense over a weighted average period of approximately 3.2 years. Restricted Stock Awards, 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 31st of the immediately preceding calendar year (or a lower amount as otherwise determined by the board of directors prior to January 1st). As of March 31, 2018, there were A summary of the Company’s restricted stock award activity for the three months ended March 31, 2018 and related information is as follows: Weighted-Average Purchase Price Shares per Share Unvested at December 31, 2017 10,816 $ 5.73 Granted — — Vested (8,112) Unvested at March 31, 2018 (1) 2,704 $ (1) A summary of the Company’s restricted stock units activity for the three months ended March 31, 2018 and related information is as follows: Weighted-Average Shares Grant Date Fair Value Outstanding at December 31, 2017 218,872 $ 12.64 Granted 312,787 23.51 Settled (32,573) 15.39 Forfeited (1,400) 21.00 Outstanding at March 31, 2018 497,686 $ 19.27 A summary of the Company’s stock option activity and related information follows: Weighted- Weighted- Average Average Remaining Aggregate Exercise Price Contractual Intrinsic Shares per Share Term (in years) Value Outstanding at December 31, 2017 3,037,690 $ 8.4 $ 16,829 Granted 792,920 Exercised (183,987) Cancelled (54,390) Outstanding at March 31, 2018 3,592,233 $ $ 36,741 Exercisable at March 31, 2018 1,086,727 $ $ 13,453 Vested and expected to vest at March 31, 2018 3,335,355 $ $ 35,236 The fair value of each stock option is estimated on the grant date using the Black-Scholes option-pricing model using the following assumptions: Three months ended March 31, 2018 2017 Risk-free interest rate % % Volatility % % Expected term (years) 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 our common stock on (1) the first day of the purchase period or (2) the last day of the purchase period. During the three months ended March 31, 2018, 50,151 shares of common stock were purchased for total proceeds of $510. The expense for the three months ended March 31, 2018 and 2017 was $122 and $106, respectively. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2018 | |
Commitments and Contingencies | |
Commitments and Contingencies | 12. Commitments and Contingencies 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 Litigation The Company filed the NDA for Xtampza 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 OP. The 505(b)(2) process requires that the Company certifies 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 OP 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 does not infringe any of the 11 Orange Book listed patents for OxyContin OP, 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. 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 label, Purdue filed another suit asserting infringement of the ʼ933 and ʼ919 patent. 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 continues to assert infringement of five patents: the ʼ497 patent, the ʼ933 patent, the ʼ717 patent, the ʼ919 patent, and the ʼ961 patent. None of these suits are associated with any stay of FDA approval for the Xtampza drug product. Purdue has made a demand for monetary relief but has not quantified their alleged damages. Purdue has also requested a judgment of infringement 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 fees for defending the case. The parties are in the early stages of fact discovery. Written discovery has commenced with depositions expected to commence during the second half of 2018. A claim construction and summary judgment 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. At this time, the Motion for Summary Judgment, which asserted that claims of the ’933, ’497, and ’717 patents are invalid and not infringed, remains pending. The Company is not able to predict with certainty when the Court will decide the Company’s motion. The Scheduling Order has been amended to stay the close of fact discovery until after the Court decides our Motion for Summary Judgment. No trial date has been scheduled. The Company is, and plans to continue, defending 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 Collegium NF, LLC and Collegium Pharmaceutical, Inc. 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. The Company filed its answer to the Complaint on April 9, 2018. Purdue filed its answer to the Company’s counterclaims on April 30, 2018. The parties are required to submit a proposed scheduling order to the court by May 9, 2018. 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 twelve patents listed in the FDA Orange Book as covering the Company’s abuse-deterrent product and methods of using it to treat patients: Patents N os . 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 and 9 , 763,883 . Teva Pharmaceuticals USA Orange Book . Teva’s response to the Company’s complaint is due on May 14, 2018. The Company plans to assert and defend its intellectual property vigorously in this case. 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 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. The action alleges a variety of claims related to opioid marketing and distribution practices, including false advertising, deceptive trade practices, public nuisance, unjust enrichment, violations of state narcotics statutes and civil conspiracy. The suit seeks monetary penalties. The Company was served with the lawsuit on April 30, 2018. On March 21, 2018, the Company and other pharmaceutical manufacturers and distributors were 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 relating to opioid marketing and distribution practices. The lawsuit seeks, generally, penalties and/or injunctive relief. On April 2, 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. The lawsuit is not designated as a representative case in the MDL and, therefore, is effectively currently 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, and Massachusetts. The Company is currently cooperating with the each of the foregoing states in their respective investigations |
Summary of Significant Accoun18
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2018 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | 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 financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States (“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 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 March 31, 2018, the results of operations for three months ended March 31, 2018 and 2017 , and cash flows for the three months ended March 31, 2018 and 2017. The results of operations for the three months ended March 31, 2018 are not necessarily indicative of the results to be expected for the full year. When preparing financial statements in conformity with GAAP, the Company must make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in the Company’s financial statements and accompanying notes. The most significant estimates in the Company’s financial statements relate to revenue recognition, including the estimates of product returns, units prescribed, discounts and allowances related to commercial sales of its products, estimates utilized in the valuation of inventory, estimates of useful lives with respect to intangible assets, accounting for stock-based compensation, contingencies, 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 |
Advertising and Product Promotion Costs | Advertising and Product Promotion Costs Advertising and product promotion costs are included in selling, general and administrative expenses and were $2,562 and $3,860 in the three months ended March 31, 2018 and 2017 respectively. Advertising and product promotion costs are expensed as incurred. |
Restricted Cash | Restricted Cash Restricted cash represents cash held in a depository account at a financial institution to collateralize a conditional stand‑by letter of credit related to the Company’s facility lease agreements. Restricted cash is reported as non‑current unless the restrictions are expected to be released in the next twelve months. |
Leases | Leases Effective March 2018, the Company entered into a lease for its new corporate headquarters (the “Lease”) pursuant to which the Company will lease approximately 50,678 of rentable square feet of space, in Stoughton, Massachusetts. The Lease will commence when the tenant improvements in the space are substantially complete and will continue thereafter for a term of ten years. The Company has the right to extend the term of the Lease for two additional five-year terms, provided that written notice is provided to the Landlord no later than twelve months prior to the expiration of the current Lease term. The initial annual base rent is $1,214, or $23.95 per rentable square foot, and will increase annually by 2.5% to 3.1% over the subsequent Lease years. The Company is still evaluating when it plans to take possession of the new space and when the Lease term will commence. |
Income Taxes | Income Taxes For the three months ended March 31, 2018 and 2017, the Company did not record a current or deferred income tax expense or (benefit) due to current and historical losses incurred by the Company. The Company's losses before income taxes consist solely of losses from domestic operations. As of March 31, 2018, the Company has recorded a full valuation allowance for deferred tax assets including NOL and tax credit carryovers. The Tax Cuts and Jobs Act of 2017 (“TCJA” or “2017 Tax Act”), which was signed into law in December 2017, has resulted in significant changes to the U.S. corporate income tax system. The SEC staff issued Staff Accounting Bulletin (SAB) 118, which provides guidance on accounting for enactment effects of the TCJA. The Company has not finalized its review of the impact of TCJA on the NOL rules, and the impact, if any, to the Company’s ability to utilize and carryover net operating losses. For additional information related to the TCJA, please read Note 13, Income Taxes, to our consolidated financial statements included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2017. |
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. In May 2014, the FASB issued Accounting Standards Update, or ASU, 2014-09, Revenue from Contracts with Customers (Topic 606) , which amends the guidance for accounting for revenue from contracts with customers. This ASU supersedes the revenue recognition requirements in ASC Topic 605, Revenue Recognition , and creates a new Topic 606, Revenue from Contracts with Customers . In 2015, 2016 and 2017, the FASB issued additional ASUs related to Topic 606, including ASUs 2015-14, 2016-08, 2016-10, 2016-12, 2016-20, 2017-13, 2017-14, that delayed the effective date of and clarified various aspects of the new guidance, including principal versus agent considerations, identifying performance obligations, and licensing. The Company adopted ASC Topic 606, Revenue from Contracts with Customers , on January 1, 2018 using the modified retrospective method for all contracts not completed as of the date of adoption. The adoption of ASU 2014-09 did not have an impact on the Company’s consolidated financial position, results of operations, equity or cash flows as of the adoption date or for the three months ended March 31, 2018. Refer to Note 3 "Revenue from Contracts with Customers" for the required disclosures and a discussion of the Company's policies related to revenue recognition. In August 2016, the FASB issued ASU 2016-15, Classification of Certain Cash Receipts and Cash Payments , and in November 2016, the FASB issued ASU 2016-18, Restricted Cash . The purpose of ASU 2016-15 is to reduce the diversity in presentation and classification of the following items within the Statement of Cash Flows: debt prepayments, settlement of zero coupon debt instruments, contingent consideration payments, insurance proceeds, securitization transactions and distributions from equity method investees. The update also addresses classification of transactions that have characteristics of more than one class of cash flows. ASU 2016-18 requires the Statement of Cash Flows to explain the change during the period in the total of cash, cash equivalents, and amounts generally described as restricted cash or restricted cash equivalents. Therefore, amounts generally described as restricted cash and restricted cash equivalents should be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the Statement of Cash Flows. The Company adopted these new standards on January 1, 2018 using the retrospective transition method as required with respect to each period presented. The adoption of these standards did not have an impact on the Company’s consolidated financial statements. Recently Issued Accounting Pronouncements Not Yet Adopted In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) . ASU 2016-02 most significantly impacts lessee accounting and disclosures. First, this guidance requires lessees to identify arrangements that should be accounted for as leases. Under ASU 2016-02, for lease arrangements exceeding a 12-month term, a right-of-use asset and lease obligation is recorded by the lessee for all leases, whether operating or financing, while the income statement will reflect lease expense for operating leases and amortization/interest expense for financing leases. The Balance Sheet amount recorded for existing leases at the date of adoption of ASU 2016-02 must be calculated using the applicable incremental borrowing rate at the date of adoption. Leases with a term of 12 months or less will be accounted for in a manner similar to existing guidance for operating leases. In addition, ASU 2016-02 requires the use of the modified retrospective method, which will require adjustment to all comparative periods presented in the consolidated financial statements. This guidance is effective for public companies for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018. Early adoption is permitted for all entities. The Company has not chosen early adoption for this ASU and is currently evaluating its effect on the Company’s consolidated financial statements. Based on its preliminary assessment, the Company expects to recognize a right-to-use asset and corresponding lease liability on its Balance Sheet related to lease agreement for its corporate headquarters upon adoption of this ASU. |
Revenue from Contracts with C19
Revenue from Contracts with Customers (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Revenue from Contracts with Customers | |
Summary of product revenue provision and allowance | Rebates and Product Trade Allowances and Incentives (1) Returns (2) Chargebacks (3) Balance at December 31, 2017 $ 12,647 $ 3,137 $ 2,256 Provision related to current period sales 58,591 4,047 16,650 Changes in estimate related to prior period sales (32) - - Credits/payments made (7,842) (809) (4,253) Balance at March 31, 2018 $ 63,364 $ 6,375 $ 14,653 (1) Rebates and discounts includes managed care rebates, government rebates, co-pay program incentives, and sales incentives and allowances. Provisions for rebates and discounts 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. (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) Trade allowances and chargebacks includes 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 March 31, 2018 2017 Xtampza $ 15,795 $ 2,172 Nucynta 47,954 — Total product revenues, net $ 63,749 $ 2,172 |
Loss per Common Share (Tables)
Loss per Common Share (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Loss per Common Share | |
Schedule of computations of basic and diluted net loss per share | Three months ended March 31, 2018 2017 Loss attributable to common shareholders — basic and diluted $ (18,652) $ (23,078) Weighted-average number of common shares used in net loss per share - basic and diluted 32,903,674 29,350,268 Loss per share - basic and diluted $ (0.57) $ (0.79) |
Schedule of potentially dilutive securities excluded from computations of diluted weighted-average shares outstanding | Three months ended March 31, 2018 2017 Outstanding stock options 3,592,233 2,835,630 Warrants 2,445 2,445 Unvested restricted stock (1) 19,303 69,870 Restricted stock units 497,686 153,361 (1) - Includes shares of unvested restricted stock remaining from the early exercise of stock options. |
Fair Value of Financial Instr21
Fair Value of Financial Instruments (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
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 March 31, 2018 Total (Level 1) (Level 2) (Level 3) Money market funds, included in cash equivalents $ 81,479 $ 81,479 $ — $ — December 31, 2017 Money market funds, included in cash equivalents $ 81,225 $ 81,225 $ — $ — |
Inventory (Tables)
Inventory (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Inventory | |
Schedule of Inventory | As of March 31, As of December 31, 2018 2017 Raw materials $ 532 $ 616 Work in process 496 322 Finished goods 6,874 875 Total inventory $ 7,902 $ 1,813 |
Intangible Assets and Asset A23
Intangible Assets and Asset Acquisition Obligations (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Intangible Assets and Asset Acquisition Obligations | |
Schedule of recognized assets and assuming liabilities | Upfront cash paid for Nucynta asset acquisition $ 18,877 Identifiable assets acquired and liabilities assumed: Intangible assets $ 515,627 Inventory 6,223 Prepaid expenses 1,987 Minimum royalty payments (482,300) Other liabilities (22,660) Total $ 18,877 |
Carrying amount of Nucynta intangible | As of March 31, 2018 Gross carrying amount $ 515,626 Accumulated amortization (29,526) Intangible assets, net $ 486,100 |
Schedule of remaining minimum royalty payments | 2018 $ 118,955 2019 135,000 2020 135,000 2021 135,000 Total remaining minimum royalty payments due $ 523,955 Less: Unamortized discount (49,172) Carrying value of minimum royalty payments $ 474,783 |
Summary of amortization expense | March 31, March 31, 2018 2017 Nucynta amortization expense included in cost of product revenues $ 29,526 $ - Onsolis amortization expense included in selling, general and administrative expense - 130 Total amortization expense $ 29,526 $ 130 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Accrued Expenses | |
Schedule of components of accrued expenses | As of March 31, As of December 31, 2018 2017 Accrued cost of product revenues $ 6,710 $ — Accrued incentive compensation 2,937 1,790 Accrued inventory 2,367 — Accrued payroll and related benefits 1,579 1,382 Accrued other operating costs 1,453 877 Accrued bonuses 883 2,940 Accrued sales and marketing 719 624 Accrued audit and legal 554 405 Accrued development costs 136 517 Accrued interest 98 6 Total accrued expenses $ 17,436 $ 8,541 |
Term Loan Payable (Tables)
Term Loan Payable (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Term Loan Payable | |
Schedule of future payments under debt agreements | 2018 $ — 2019 1,642 2020 3,286 2021 3,286 2022 3,286 Balance $ 11,500 |
Equity (Tables)
Equity (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Equity | |
Summary of Changes in Shareholders' Equity | Additional Total Common Stock Paid- In Accumulated Shareholders’ Shares Amount Capital Deficit Equity (Deficit) Balance, December 31, 2017 32,770,678 $ 33 $ 402,096 $ (298,049) $ 104,080 Exercise of common stock options 183,987 — 2,373 — 2,373 Issuance for employee stock purchase plan 50,151 — 510 — 510 Vesting of restricted stock units 32,573 — — — — Shares withheld for employee taxes upon vesting of restricted stock units (9,810) — (216) — (216) Stock-based compensation — — 2,728 — 2,728 Net loss — — — (18,652) (18,652) Balance, March 31, 2018 33,027,579 $ 33 $ 407,491 $ (316,701) $ 90,823 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Stock-based Compensation | |
Summary of stock-based compensation included in statement of operations | Three months ended March 31, 2018 2017 Research and development expenses $ 324 $ 209 Selling, general and administrative expenses 2,404 1,612 Total stock-based compensation expense $ 2,728 $ 1,821 |
Summary of restricted stock awards activity | Weighted-Average Purchase Price Shares per Share Unvested at December 31, 2017 10,816 $ 5.73 Granted — — Vested (8,112) Unvested at March 31, 2018 (1) 2,704 $ (1) |
Summary of restricted stock units activity | Weighted-Average Shares Grant Date Fair Value Outstanding at December 31, 2017 218,872 $ 12.64 Granted 312,787 23.51 Settled (32,573) 15.39 Forfeited (1,400) 21.00 Outstanding at March 31, 2018 497,686 $ 19.27 |
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, 2017 3,037,690 $ 8.4 $ 16,829 Granted 792,920 Exercised (183,987) Cancelled (54,390) Outstanding at March 31, 2018 3,592,233 $ $ 36,741 Exercisable at March 31, 2018 1,086,727 $ $ 13,453 Vested and expected to vest at March 31, 2018 3,335,355 $ $ 35,236 |
Schedule of weighted-average assumptions used in Black-Scholes option-pricing model | Three months ended March 31, 2018 2017 Risk-free interest rate % % Volatility % % Expected term (years) Expected dividend yield — % — % |
Nature of Business (Details)
Nature of Business (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2018 | Dec. 31, 2017 | |
Nature of Business | |||
Accumulated deficit | $ 316,701 | $ 298,049 | |
Public offering of common stock, net of issuance costs (in shares) | 3,126,998 | ||
Offering price (in dollars per share) | $ 11.36 | ||
Sale of Stock, Consideration Received if Additional Shares are Issued | $ 60,000 | ||
Commission fee percentage on gross proceeds from sale of ATM shares | 3.00% | ||
Proceeds from the offering, after deducting underwriting discounts and commissions | $ 34,283 |
Summary of Significant Accoun29
Summary of Significant Accounting Policies - Narrative (Details) | 3 Months Ended | |
Mar. 31, 2018USD ($)ft²item$ / sharesshares | Mar. 31, 2017USD ($) | |
Stock Issued During Period, Shares, New Issues | shares | 3,126,998 | |
Shares Issued, Price Per Share | $ / shares | $ 11.36 | |
Marketing and Advertising Expense | $ 2,562,000 | $ 3,860,000 |
Net cash used in investing activities | $ (19,117,000) | $ (29,000) |
Square of feet of space | ft² | 50,678 | |
Lease term | 10 years | |
Number of renewal periods | item | 2 | |
Term of lease extension option | 5 years | |
Initial annual base rent | $ 1,214,000 | |
Annual increase in base rent (per square foot) | $ 23.95 | |
Minimum | ||
Increase in annual base rent | 2.50% | |
Maximum | ||
Increase in annual base rent | 3.10% |
Revenue from Contracts with C30
Revenue from Contracts with Customers - Narrative (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2018USD ($) | |
Revenue from Contracts with Customers | |
Revenue recognition for product sales | $ 1,220 |
Practical expedient incremental cost | true |
Asset acquisition liabilities assumed in accrued rebates, returns and discounts | $ 22,660 |
Revenue from Contracts with C31
Revenue from Contracts with Customers - contract liabilities (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2018USD ($) | |
Rebates and Incentives | |
Allowance categories | |
Balance at Beginning of the period | $ 12,647 |
Provision related to current period sales | 58,591 |
Changes in estimate related to prior period sales | (32) |
Credits/payments made | (7,842) |
Balance at End of the period | 63,364 |
Product Returns | |
Allowance categories | |
Balance at Beginning of the period | 3,137 |
Provision related to current period sales | 4,047 |
Credits/payments made | (809) |
Balance at End of the period | 6,375 |
Trade Allowances and Chargebacks | |
Allowance categories | |
Balance at Beginning of the period | 2,256 |
Provision related to current period sales | 16,650 |
Credits/payments made | (4,253) |
Balance at End of the period | $ 14,653 |
Revenue from Contracts with C32
Revenue from Contracts with Customers - Disaggregation of Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Disaggregation of Revenue | ||
Revenue | $ 63,749 | $ 2,172 |
Xtampza | ||
Disaggregation of Revenue | ||
Revenue | 15,795 | $ 2,172 |
Nucynta | ||
Disaggregation of Revenue | ||
Revenue | $ 47,954 |
Loss per Common Share - Computa
Loss per Common Share - Computation of Earnings per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Loss per Common Share | ||
Net loss | $ (18,652) | $ (23,078) |
Loss attributable to common shareholders — basic and diluted | $ (18,652) | $ (23,078) |
Weighted-average number of common shares used in net loss per share - basic and diluted | 32,903,674 | 29,350,268 |
Loss per share - basic and diluted | $ (0.57) | $ (0.79) |
Loss per Common Share - Summary
Loss per Common Share - Summary of Potentially Dilutive Securities (Details) - shares | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Stock options | ||
Anti-dilutive securities | ||
Potentially dilutive securities excluded from the computations of diluted weighted-average shares outstanding | 3,592,233 | 2,835,630 |
Warrants | ||
Anti-dilutive securities | ||
Potentially dilutive securities excluded from the computations of diluted weighted-average shares outstanding | 2,445 | 2,445 |
Unvested restricted stock | ||
Anti-dilutive securities | ||
Potentially dilutive securities excluded from the computations of diluted weighted-average shares outstanding | 19,303 | 69,870 |
Restricted stock units | ||
Anti-dilutive securities | ||
Potentially dilutive securities excluded from the computations of diluted weighted-average shares outstanding | 497,686 | 153,361 |
Fair Value of Financial Instr35
Fair Value of Financial Instruments (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Dec. 31, 2017 | |
Royalty liability | $ 482,300 | |
Discount rate used to calculate present value of royalty payments | 5.70% | |
Money market funds | ||
Cash equivalents | $ 81,479 | $ 81,225 |
Quoted Prices in active markets (Level 1) | Money market funds | ||
Cash equivalents | $ 81,479 | $ 81,225 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Inventory | ||
Raw materials | $ 532 | $ 616 |
Work in process | 496 | 322 |
Finished goods | 6,874 | 875 |
Total inventory | $ 7,902 | $ 1,813 |
Intangible Assets and Asset A37
Intangible Assets and Asset Acquisition Obligations - Recognized at cost component of intangible assets (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2018USD ($) | |
Intangible Assets and Asset Acquisition Obligations | |
Upfront cash paid for Nucynta asset acquisition | $ 18,877 |
Identifiable assets acquired and liabilities assumed: | |
Intangible assets | 515,627 |
Inventory | 6,223 |
Prepaid expenses | 1,987 |
Minimum royalty payments | (482,300) |
Other liabilities | (22,660) |
Total | $ 18,877 |
Intangible Assets and Asset A38
Intangible Assets and Asset Acquisition Obligations - Amortization expense for Nucynta Intangible Asset (Details) - USD ($) $ in Thousands | Jan. 09, 2018 | Mar. 31, 2018 |
Intangible Assets and Asset Acquisition Obligations | ||
Useful life | 4 years | |
Accumulated amortization | $ 29,526 | |
Remaining amortization period | 3 years 9 months 18 days | |
Reminder of 2018 | $ 97,219 | |
2,019 | 129,627 | |
2,020 | 129,627 | |
2,021 | $ 129,627 |
Intangible Assets and Asset A39
Intangible Assets and Asset Acquisition Obligations - Gross carrying amount and accumulated amortization (Details) $ in Thousands | Mar. 31, 2018USD ($) |
Accumulated amortization | $ (29,526) |
Commercialization Agreement - Nucynta [Member] | |
Gross carrying amount | 515,626 |
Accumulated amortization | (29,526) |
Intangible assets, net | $ 486,100 |
Intangible Assets and Asset A40
Intangible Assets and Asset Acquisition Obligations - Nucynta Asset Acquisition Obligations (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Jan. 09, 2018 | |
Intangible Assets and Asset Acquisition Obligations | ||
Annual royalty payable | $ 135,000 | |
Quarterly royalty payable | $ 33,750 | |
Minimum royalty payable | $ 537,000 | |
Royalty payment period | 45 days | |
Fair Value of royalty payments | $ 482,300 | |
Discounted cash flow rate | 5.70% | |
Discount | $ 54,700 | |
Interest expense | 5,528 | |
Royalty payment due before payment | 30,750 | |
Remainder of 2018 | 16,855 | |
2,019 | 17,138 | |
2,020 | 10,907 | |
2,021 | 4,272 | |
Payment of royalty | 13,045 | |
Quarterly payment due | $ 17,705 |
Intangible Assets and Asset A41
Intangible Assets and Asset Acquisition Obligations - Remaining minimum royalty payments (Details) $ in Thousands | Mar. 31, 2018USD ($) |
Intangible Assets and Asset Acquisition Obligations | |
2,018 | $ 118,955 |
2,019 | 135,000 |
2,020 | 135,000 |
2,021 | 135,000 |
Total remaining minimum royalty payments due | 523,955 |
Less: Unamortized discount | (49,172) |
Carrying value of minimum royalty payments | $ 474,783 |
Intangible Assets and Asset A42
Intangible Assets and Asset Acquisition Obligations - Onsolis Intangible Asset (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2018 | Mar. 31, 2017 | Dec. 31, 2017 | Dec. 31, 2016 | |
Finite-Lived Intangible Assets [Line Items] | ||||
Amortization expense | $ 29,526 | $ 130 | ||
Onsolis | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Upfront cash payment | $ 2,500 | |||
Intangible assets, net | $ 0 | $ 0 | ||
Selling, general and administrative expenses | Onsolis | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Impairment loss | $ 1,845 | |||
Amortization expense | $ 130 |
Intangible Assets and Asset A43
Intangible Assets and Asset Acquisition Obligations - Amortization Expense for Onsolis Intangible Asset (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Finite-Lived Intangible Assets [Line Items] | ||
Amortization expense | $ 29,526 | $ 130 |
Nucynta | Cost of product revenues | ||
Finite-Lived Intangible Assets [Line Items] | ||
Amortization expense | $ 29,526 | |
Onsolis | Selling, general and administrative expenses | ||
Finite-Lived Intangible Assets [Line Items] | ||
Amortization expense | $ 130 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Accrued Expenses | ||
Accrued cost of product revenues | $ 6,710 | |
Accrued incentive compensation | 2,937 | $ 1,790 |
Accrued inventory | 2,367 | |
Accrued payroll and related benefits | 1,579 | 1,382 |
Accrued other operating costs | 719 | 624 |
Accrued bonuses | 1,453 | 877 |
Accrued sales and marketing | 883 | 2,940 |
Accrued audit and legal | 554 | 405 |
Accrued development costs | 136 | 517 |
Accrued interest | 98 | 6 |
Total accrued expenses | $ 17,436 | $ 8,541 |
Term Loan Payable (Details)
Term Loan Payable (Details) $ in Thousands | 3 Months Ended | |||
Mar. 31, 2018USD ($)itemshares | Dec. 31, 2017USD ($) | Aug. 31, 2012USD ($) | Aug. 28, 2012USD ($) | |
Loan and Security Agreements | ||||
Maximum borrowing capacity | $ 1,000 | |||
Proceeds from term loan amendment, net of repayment of amended term loan | $ 10,020 | |||
Public offering of common stock, net of issuance costs (in shares) | shares | 3,126,998 | |||
2,019 | $ 1,642 | $ 1,479 | ||
Term loan | Silicon Valley Bank loan agreement | Prime | ||||
Loan and Security Agreements | ||||
Variable interest rate margin (as a percent) | 2.25% | |||
Interest rate (as a percent) | 5.50% | |||
Term loan | Silicon Valley Bank loan agreement Amendment No. 2 | ||||
Loan and Security Agreements | ||||
Maximum borrowing capacity | $ 8,000 | |||
New Term Loan | Silicon Valley Bank Loan Agreement Consent and Sixth Amendment | ||||
Loan and Security Agreements | ||||
Original principal amount | $ 11,500 | |||
Threshold limit of EDITDA to repay principal and interest prior to specific date | $ 2,500 | |||
Number of consecutive calendar quarters to maintain threshold limit of EDITDA to repay principal and interest prior to specific date | item | 2 | |||
Final payment fee | $ 719 | |||
Minimum liquidity ratio | 2 | |||
Additional interest rate in event of default | 5 | |||
New Term Loan | Silicon Valley Bank Loan Agreement Consent and Sixth Amendment | Prime | ||||
Loan and Security Agreements | ||||
Variable interest rate margin (as a percent) | 0.75% | |||
Variable rate basis | prime rate | |||
Standby letter of credit | New Term Loan | ||||
Loan and Security Agreements | ||||
Maximum borrowing capacity | $ 33,750 | |||
Prior to first anniversary | New Term Loan | Silicon Valley Bank Loan Agreement Consent and Sixth Amendment | ||||
Loan and Security Agreements | ||||
Prepayment fee (as a percent) | 3 | |||
Between first anniversary and second anniversary | New Term Loan | Silicon Valley Bank Loan Agreement Consent and Sixth Amendment | ||||
Loan and Security Agreements | ||||
Prepayment fee (as a percent) | 2 | |||
Following second anniversary | New Term Loan | Silicon Valley Bank Loan Agreement Consent and Sixth Amendment | ||||
Loan and Security Agreements | ||||
Prepayment fee (as a percent) | 1 |
Term Loan Payable - Future Paym
Term Loan Payable - Future Payments (Details) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Future payments under term loan | ||
2,019 | $ 1,642 | $ 1,479 |
2,020 | 3,286 | |
2,021 | 3,286 | |
2,022 | 3,286 | |
Balance | $ 11,500 |
Equity - Changes in Shareholder
Equity - Changes in Shareholders' Equity (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Balance at beginning of period | $ 104,080 | |
Exercise of common stock options | $ 2,373 | |
Exercise of common stock options, shares | 183,987 | |
Issuance for employee stock purchase plan | $ 510 | |
Issuance for employee stock purchase plan, shares | 50,151 | |
Shares withheld for employee taxes upon vesting of restricted stock units | $ (216) | |
Public offering of common stock, net of issuance costs (in shares) | 3,126,998 | |
Stock-based compensation expense | $ 2,728 | |
Net loss | (18,652) | $ (23,078) |
Balance at end of period | 90,823 | |
Cash paid for common stock offerings costs | 30 | |
Common Stock | ||
Balance at beginning of period | $ 33 | |
Balance at beginning of year, shares | 32,770,678 | |
Exercise of common stock options, shares | 183,987 | |
Issuance for employee stock purchase plan, shares | 50,151 | |
Vesting of restricted stock units, shares | 32,573 | |
Shares withheld for employee taxes upon vesting of restricted stock units, shares | (9,810) | |
Balance at end of period | $ 33 | |
Balance at end of year, shares | 33,027,579 | |
Additional Paid-In Capital | ||
Balance at beginning of period | $ 402,096 | |
Exercise of common stock options | 2,373 | |
Issuance for employee stock purchase plan | 510 | |
Shares withheld for employee taxes upon vesting of restricted stock units | (216) | |
Stock-based compensation expense | 2,728 | |
Balance at end of period | 407,491 | |
Accumulated Deficit | ||
Balance at beginning of period | (298,049) | |
Net loss | (18,652) | |
Balance at end of period | $ (316,701) |
Stock-based Compensation - Narr
Stock-based Compensation - Narrative (Details) - USD ($) | 3 Months Ended | |||
Mar. 31, 2018 | Mar. 31, 2017 | Dec. 31, 2017 | May 31, 2015 | |
Stock-based compensation | ||||
Shares of common stock authorized for issuance outstanding (in shares) | 3,592,233 | 3,037,690 | ||
Employee Stock Purchase Plan, Purchase Price Percentage | 85.00% | |||
Issuance for employee stock purchase plan, shares | 50,151 | |||
Proceeds from issuances of common stock from employee stock purchase plans | $ 510,000 | $ 673,000 | ||
Employee Stock Purchase Plan, Compensation Expense | 122,000 | $ 106,000 | ||
Restricted Stock Awards And Restricted Stock Units | ||||
Stock-based compensation | ||||
Unrecognized compensation cost related to outstanding options | $ 33,065 | |||
Period over which unrecognized compensation cost is expected to be recognized as expense | 3 years 2 months 12 days | |||
2014 Stock Incentive Plan | ||||
Stock-based compensation | ||||
Shares of common stock authorized for issuance (in shares) | 2,700,000 | |||
Shares of common stock remaining available for future grant | 1,395,405 | |||
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% | |||
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 - Summ
Stock-based Compensation - Summary of Stock-Based Compensation Included in Statement of Operations (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Stock-based compensation | ||
Total stock-based compensation expense | $ 2,728 | $ 1,821 |
Research and development expenses | ||
Stock-based compensation | ||
Total stock-based compensation expense | 324 | 209 |
Selling, general and administrative expenses | ||
Stock-based compensation | ||
Total stock-based compensation expense | $ 2,404 | $ 1,612 |
Stock-based Compensation - Su50
Stock-based Compensation - Summary of Restricted Stock Award Activity (Details) - Restricted Stock Awards | 3 Months Ended |
Mar. 31, 2018$ / sharesshares | |
Restricted stock awards | |
Balance | 10,816 |
Vested/Settled | (8,112) |
Balance | 2,704 |
Unvested remaining from the early exercise of stock options (in shares) | 16,599 |
Weighted-average purchase price per share | |
Balance | $ / shares | $ 5.73 |
Vested/Settled | $ / shares | 5.73 |
Balance | $ / shares | $ 5.73 |
Stock-based Compensation - Su51
Stock-based Compensation - Summary of Restricted Stock Units Activity (Details) - Restricted stock units | 3 Months Ended |
Mar. 31, 2018$ / sharesshares | |
Restricted stock awards | |
Balance | shares | 218,872 |
Granted | shares | 312,787 |
Vested/Settled | shares | (32,573) |
Forfeited | shares | (1,400) |
Balance | shares | 497,686 |
Weighted-average purchase price per share | |
Balance | $ / shares | $ 12.64 |
Granted | $ / shares | 23.51 |
Vested/Settled | $ / shares | 15.39 |
Forfeited | $ / shares | 21 |
Balance | $ / shares | $ 19.27 |
Stock-based Compensation - Su52
Stock-based Compensation - Summary of Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2018 | Dec. 31, 2017 | |
Stock option activity | ||
Outstanding | 3,037,690 | |
Granted | 792,920 | |
Exercised | (183,987) | |
Cancelled | (54,390) | |
Outstanding | 3,592,233 | 3,037,690 |
Exercisable at end of period | 1,086,727 | |
Vested and expected to vest at end of period | 3,335,355 | |
Weighted average exercise price per share | ||
Outstanding | $ 13 | |
Granted | 24.23 | |
Exercised | 12.90 | |
Cancelled | 15.27 | |
Outstanding | 15.45 | $ 13 |
Exercisable at end of period | 13.17 | |
Vested and expected to vest at end of period | $ 15.09 | |
Stock option activity, additional information | ||
Outstanding Weighted-Average Remaining Contractual Term | 8 years 7 months 6 days | 8 years 4 months 24 days |
Outstanding Aggregate Intrinsic Value | $ 36,741 | $ 16,829 |
Exercisable at end of period, Weighted-Average Remaining Contractual Term | 7 years 7 months 6 days | |
Exercisable at end of period, Aggregate Intrinsic Value | $ 13,453 | |
Vested and expected to vest at end of period, Weighted-Average Remaining Contractual Term | 8 years 6 months | |
Vested and expected to vest at end of period, Aggregate Intrinsic Value | $ 35,236 |
Stock-based Compensation - Su53
Stock-based Compensation - Summary of Valuation Assumptions Used (Details) | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
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 | 2.60% | 2.10% |
Volatility | 64.00% | 72.30% |
Expected term (in years) | 6 years 2 months 1 day | 6 years 22 days |
Commitments and Contingencies (
Commitments and Contingencies (Details) - patent | Mar. 24, 2015 | Feb. 11, 2015 | Mar. 31, 2018 |
Purdue Pharma, L. P. patent infringement suit, District of Delaware | |||
Contingencies | |||
Stay period before FDA can issue a final approval unless it is terminated | 30 months | ||
Number of patents asserted infringed | 3 | ||
Teva Litigation [member] | |||
Contingencies | |||
Stay period before FDA can issue a final approval unless it is terminated | 30 days | ||
Number of patents asserted infringed | 11 | ||
Number of patents listed in FDA Orange Book | 12 | ||
Teva Litigation [member] | Maximum | |||
Contingencies | |||
Stay period before FDA can issue a final approval unless it is terminated | 45 days | ||
Xtampza Litigation | |||
Contingencies | |||
Stay period before FDA can issue a final approval unless it is terminated | 30 months | ||
Total number of Orange Book patents asserted to have been infringed | 11 | ||
Total number of non-Orange Book patents asserted to have been infringed | 5 |