Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2017 | Oct. 31, 2017 | |
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 | Sep. 30, 2017 | |
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 | 32,562,277 | |
Document Fiscal Year Focus | 2,017 | |
Document Fiscal Period Focus | Q3 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Current assets: | ||
Cash and cash equivalents | $ 107,611 | $ 153,225 |
Accounts receivable | 5,823 | 2,129 |
Inventory | 1,401 | 1,316 |
Prepaid expenses and other current assets | 4,061 | 1,905 |
Total current assets | 118,896 | 158,575 |
Property and equipment, net | 1,632 | 1,038 |
Intangible assets, net | 1,877 | 2,103 |
Restricted cash | 97 | 97 |
Other long-term assets | 171 | 204 |
Total assets | 122,673 | 162,017 |
Current liabilities: | ||
Accounts payable | 4,982 | 9,106 |
Accrued expenses | 19,268 | 8,879 |
Deferred revenue | 4,944 | |
Current portion of term loan payable | 2,146 | 2,667 |
Total current liabilities | 26,396 | 25,596 |
Lease incentive obligation | 8 | 34 |
Term loan payable, long-term | 1,479 | |
Total liabilities | 26,404 | 27,109 |
Commitments and contingencies (see Note 10) | ||
Shareholders' equity: | ||
Preferred stock, $0.001 par value; authorized shares - 5,000,000 at September 30, 2017 and December 31, 2016; issued and outstanding shares - none at September 30, 2017 and December 31, 2016 | ||
Common stock, $0.001 par value; authorized shares - 100,000,000 at September 30, 2017 and December 31, 2016; issued and outstanding shares - 30,765,100 at September 30, 2017 and 29,364,100 at December 31, 2016 | 31 | 29 |
Additional paid-in capital | 376,884 | 358,063 |
Accumulated deficit | (280,646) | (223,184) |
Total shareholders' equity | 96,269 | 134,908 |
Total liabilities and shareholders' equity | $ 122,673 | $ 162,017 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2017 | Dec. 31, 2016 |
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 | 30,765,100 | 29,364,100 |
Common stock, outstanding shares | 30,765,100 | 29,364,100 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Revenues | ||||
Product revenues, net | $ 11,950 | $ 408 | $ 17,682 | $ 408 |
Costs and expenses | ||||
Cost of product revenues | 553 | 29 | 1,501 | 29 |
Research and development | 2,069 | 3,254 | 6,378 | 11,617 |
Selling, general and administrative | 22,758 | 23,567 | 67,667 | 55,266 |
Total costs and expenses | 25,380 | 26,850 | 75,546 | 66,912 |
Loss from operations | (13,430) | (26,442) | (57,864) | (66,504) |
Other expense (income): | ||||
Interest income (expense), net | 167 | (2) | 402 | (113) |
Net loss | $ (13,263) | $ (26,444) | $ (57,462) | $ (66,617) |
Loss per share - basic and diluted | $ (0.45) | $ (1.13) | $ (1.95) | $ (2.85) |
Weighted-average shares - basic and diluted | 29,753,043 | 23,460,340 | 29,517,396 | 23,334,558 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Operating activities | ||
Net loss | $ (57,462) | $ (66,617) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 464 | 360 |
Lease incentive | (26) | (25) |
Stock-based compensation expense | 5,867 | 4,137 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (3,694) | (1,679) |
Inventories | (85) | (1,576) |
Prepaid expenses and other assets | (33) | (114) |
Accounts payable | (4,124) | 5,401 |
Accrued expenses | 10,315 | 4,409 |
Deferred revenue | (4,944) | 3,938 |
Net cash used in operating activities | (53,722) | (51,766) |
Investing activities | ||
Purchase of intangible assets | (2,500) | |
Purchases of property and equipment | (818) | (136) |
Net cash used in investing activities | (818) | (2,636) |
Financing activities | ||
Proceeds from issuances of common stock from public offerings, net of issuance costs of $507 and $526 | 9,425 | 51,619 |
Proceeds from issuances of common stock from employee stock purchase plans | 1,141 | |
Repayment of term note | (2,000) | (2,000) |
Proceeds from the exercise of stock options | 428 | 114 |
Payments made for employee restricted stock tax withholdings | (68) | |
Net cash provided by financing activities | 8,926 | 49,733 |
Net (decrease) increase in cash and cash equivalents | (45,614) | (4,669) |
Cash and cash equivalents at beginning of period | 153,225 | 95,697 |
Cash and cash equivalents at end of period | 107,611 | 91,028 |
Supplemental disclosure of cash flow information | ||
Cash paid for offering costs | 447 | 512 |
Cash paid for interest | 121 | $ 226 |
Supplemental disclosure of non-cash activities | ||
Offering costs in accrued expenses | 60 | |
Receivable from issuance of common stock from at-the-market offering in other current assets | 2,090 | |
Acquisition of property and equipment in accrued expenses | $ 97 |
CONSOLIDATED STATEMENTS OF CAS6
CONSOLIDATED STATEMENTS OF CASH FLOWS (Parenthetical) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
CONSOLIDATED STATEMENTS OF CASH FLOWS | ||
Issuance costs | $ 507 | $ 526 |
NATURE OF BUSINESS
NATURE OF BUSINESS | 9 Months Ended |
Sep. 30, 2017 | |
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 developing and commercializing next-generation abuse-deterrent products that incorporate the Company’s patented DETERx® technology platform for the treatment of chronic pain and other diseases. 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. 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, the need to retain key personnel and protect 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 September 30, 2017 had an accumulated deficit of $280,646. The Company expects to continue to incur net losses in the foreseeable 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 September 30, 2017, together with expected cash inflows from the commercialization of Xtampza, as well as proceeds from its ATM offering through October 2017 (see note 2), will enable the Company to fund its operating expenses, debt service and capital expenditure requirements into mid-2019. 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 | 9 Months Ended |
Sep. 30, 2017 | |
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, a wholly-owned subsidiary 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 as of September 30, 2017, the results of operations for three and nine months ended September 30, 2017 and 2016 , and cash flows for the nine months ended September 30, 2017 and 2016. The results of operations for the three and nine months ended September 30, 2017 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 Xtampza, estimates utilized in the valuation of inventory, estimates of useful lives with respect to intangible assets, accounting for stock-based compensation, contingencies, intangible assets, tax valuation reserves and accrued expenses. 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. Public Offerings of Common Stock In January 2016, the Company issued and sold in a public offering an aggregate of 2,750,000 shares of its common stock at $20.00 per share. The Company received net proceeds from this public offering of approximately $51,174, after deduction of underwriting discounts and commissions and expenses payable by the Company. In October 2016, the Company issued and sold in a public offering an aggregate of 5,750,000 shares of its common stock at $16.00 per share. The Company received net proceeds from this public offering of approximately $86,166, after deduction of underwriting discounts and commissions and expenses payable by the Company. 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 September 30, 2017, the Company had sold an aggregate of 1,148,466 ATM Shares under the ATM Sales Agreement at an average gross sales price of $10.42 per share generating net proceeds of $11,455, after deduction of underwriting discounts and commissions and expenses payable by the Company, all of which were sold during the three months ended September 30, 2017. Revenue Recognition Revenue for product sales is recognized when there is persuasive evidence of an arrangement, title and risk of loss have passed to the customer, which generally occurs upon delivery, and when estimated provisions for chargebacks, rebates, sales incentives and allowances, distribution service fees, and returns are reasonably determinable, and when collectability is reasonably assured. Product sales are recorded net of estimated chargebacks, rebates, sales incentives and allowances, distribution service fees, as well as estimated product returns. Beginning in the third quarter of 2017, the Company has determined that it has sufficient experience with sales of Xtampza to estimate its returns at time of shipment. The Company sells its products primarily to distributors and retailers (“customers”), which in turn sell the product to pharmacies for the treatment of patients. The Company provides the right of return to its customers for a limited time before and after its expiration date. As a result of its experience to date with Xtampza sales, the Company determined that it can reasonably estimate the amount of future product returns. The effect on income from operations and on net income is that the Company is able to recognize revenue earlier on the sell-in method, net of a provision for estimated returns, because the Company can record revenue once sold to the customer rather than waiting until the product is sold to the end user on a sell-through method. The Company recorded a one-time $4,377 increase to revenues during the three months ended September 30, 2017 as a result of the Company’s change to the sell-in method in the third quarter of 2017. Subsequent Events The Company considers events or transactions that occur after the balance sheet date but before the financial statements are issued to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure. Subsequent events have been evaluated through the date of issuance of these financial statements. In October 2017, the Company sold an additional 1,793,290 ATM Shares under the ATM Sales Agreement at an average gross sales price of $11.29 per share generating net proceeds of $19,646, after deduction of underwriting discounts and commissions and expenses payable by the Company. 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 on Form 10-K for the fiscal year ended December 31, 2016. Advertising and Product Promotion Costs Advertising and product promotion costs are included in selling, general and administrative expenses and were $2,489 and $3,486 in the three months ended September 30, 2017 and 2016 respectively. Advertising and product promotion costs were $8,916 and $10,492 in the nine months ended September 30, 2017 and 2016 respectively. Advertising and product promotion costs are expensed as incurred. Recent 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 (ASC 606), Revenue from Contracts with Customers , which affects any entity that either enters into contracts with customers to transfer goods and services or enters into contracts for the transfer of nonfinancial assets. In August 2015, the FASB issued ASU 2015-14, Revenue from Contracts with Customers , which defers the effective date of ASU 2014-09 for all entities by one year. ASU 2014-09, which has been codified with the Accounting Standards Codification as Topic 606, is now effective for public companies for annual reporting periods beginning after December 15, 2017, including interim periods within those reporting periods. ASC 606 outlines a single comprehensive model for entities to use in accounting for revenue arising from contracts with customers and supersedes most current revenue recognition guidance, including industry-specific guidance. In addition, ASC 606 provides guidance on accounting for certain revenue-related costs including, but not limited to, when to capitalize costs associated with obtaining and fulfilling a contract. ASC 606 provides companies with two implementation methods. Companies can choose to apply the standard retrospectively to each prior reporting period presented (full retrospective application) or retrospectively with the cumulative effect of initially applying the standard as an adjustment to the opening balance of retained earnings of the annual reporting period that includes the date of initial application (modified retrospective application). Since ASU 2014-09 was issued, several additional ASUs have been issued and incorporated within ASC 606 to clarify various elements of the guidance. The Company will adopt the standard in the first quarter of 2018 using the modified retrospective method. The new standard differs from the current accounting standard in many respects, including the accounting for variable consideration. Under the Company’s current accounting policy, the Company recognizes product revenues and cost of product revenues at time of delivery to customers. The Company is still evaluating its contracts with customers and assessing the potential impacts of the new standard on existing arrangements. However, the Company does not expect the implementation of this guidance will have a material impact on its consolidated financial statements as the timing of revenue recognition for product sales is not expected to change significantly. 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 similar to existing guidance for operating leases today. 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. 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 amendments in these updates are effective for public business entities for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. The Company will adopt these standards in the first quarter of 2018 using the retrospective transition method as required with respect to each period presented. The Company expects the adoption of these standards will result in an increase in net cash provided by investing activities of $16 for the year ended December 31, 2015. The Company does not expect the adoption of these standards to have a material impact on its consolidated financial statements for the years ended December 31, 2016 or December 31, 2017. |
LOSS PER COMMON SHARE
LOSS PER COMMON SHARE | 9 Months Ended |
Sep. 30, 2017 | |
LOSS PER COMMON SHARE | |
LOSS PER COMMON SHARE | 3. Loss per Common Share The following table presents the computations of basic and dilutive net loss per share: Three months ended September 30, Nine months ended September 30, 2017 2016 2017 2016 Loss attributable to common shareholders — basic and diluted $ (13,263) $ (26,444) $ (57,462) $ (66,617) Weighted-average number of common shares used in net loss per share - basic and diluted 29,753,043 23,460,340 29,517,396 23,334,558 Loss per share - basic and diluted $ (0.45) $ (1.13) $ (1.95) $ (2.85) 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 September 30, Nine months ended September 30, 2017 2016 2017 2016 Outstanding stock options 3,056,954 2,258,775 3,056,954 2,258,775 Warrants 2,445 2,445 2,445 2,445 Unvested restricted stock (1) 44,586 95,159 44,586 95,159 Restricted stock units 218,872 41,739 218,872 41,739 (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 | 9 Months Ended |
Sep. 30, 2017 | |
FAIR VALUE OF FINANCIAL INSTRUMENTS | |
FAIR VALUE OF FINANCIAL INSTRUMENTS | 4. Fair Value of Financial Instruments Disclosures of fair value information about financial instruments are required, whether or not recognized in the balance sheet, 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 in (unadjusted) 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 September 30, 2017 and December 31, 2016. Significant Quoted Prices other Significant in active observable unobservable markets inputs inputs Description Total (Level 1) (Level 2) (Level 3) September 30, 2017 Money market funds, included in cash equivalents $ 81,026 $ 81,026 $ — $ — December 31, 2016 Money market funds, included in cash equivalents $ 125,515 $ 125,515 $ — $ — 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 September 30, 2017 and December 31, 2016 the carrying amounts of cash and cash equivalents, accounts receivable, prepaid expenses, accounts payable, accrued expenses, deferred revenue and loan payable approximated their estimated fair values because of the short-term nature of these financial instruments. |
INVENTORY
INVENTORY | 9 Months Ended |
Sep. 30, 2017 | |
INVENTORY | |
INVENTORY | 5. Inventory Inventory consisted of the following: As of September 30, As of December 31, 2017 2016 Raw materials $ 599 $ 294 Work in process 168 67 Finished goods 634 955 Total inventory $ 1,401 $ 1,316 The aggregate charges related to excess inventory for both the nine months ended September 30, 2017 and 2016 were immaterial. These expenses were recorded as a component of cost of product revenues. |
INTANGIBLE ASSETS
INTANGIBLE ASSETS | 9 Months Ended |
Sep. 30, 2017 | |
INTANGIBLE ASSETS | |
INTANGIBLE ASSETS | 6. 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. The Company expects to launch the product after the completion of the transfer of manufacturing and required submission to the FDA of a Prior Approval Supplement. Subject to FDA approval of the Prior Approval Supplement, the Company expects to launch Onsolis in mid-2018. In addition, during the term of the License Agreement, milestone payments in the aggregate amount of $21,000 may become payable by the Company subject to the satisfaction of certain commercialization, intellectual property, and net sales milestones, including $4,000 upon the first commercial sale of the product in the U.S. Finally, the Company will be required to pay royalties in the upper teens based on annual net sales of the product in the U.S. As of September 30, 2017, the Company has not satisfied the criteria for triggering payment of milestones or royalties under the License Agreement and has not recognized any liabilities for such milestones or royalties in its consolidated financial statements. The Company made an upfront payment of $2,500 and is contractually committed to reimburse BDSI up to a maximum of $2,000 for its out-of-pocket expenses incurred in connection with the manufacturing transfer. The Company recorded the upfront payment as an intangible asset on the Condensed Consolidated Balance Sheet and will amortize it on a straight-line basis over the remaining patent life. As of September 30, 2017, the Company has reimbursed BDSI approximately $1,391 for its out-of-pocket expenses incurred in connection with the manufacturing transfer. As a result of U.S. Patent No. 9,597,288 being issued in March 2017, the patent protection for Onsolis was extended through July 2027, a period of approximately 11.2 years from the date of original acquisition. As such, the Company revised the useful life of its intangible asset during the three months ended March 31, 2017 from 3.7 years to 11.2 years. During the three months ended September 30, 2017, the Company recognized amortization expense of $48 compared to $227 for the three months ended September 30, 2016. For the nine months ended September 30, 2017 the Company recognized amortization expense of $225 compared to $227 for the nine months ended September 30, 2016. As of September 30, 2017, the remaining amortization period is approximately 9.8 years and estimated remaining amortization for 2017, 2018, 2019, 2020, 2021 and thereafter is expected to be $47, $191, $191 $191, $191 and $1,066, respectively. |
ACCRUED EXPENSES
ACCRUED EXPENSES | 9 Months Ended |
Sep. 30, 2017 | |
ACCRUED EXPENSES | |
ACCRUED EXPENSES | 7. Accrued Expenses Accrued expenses consisted of the following: As of September 30, As of December 31, 2017 2016 Accrued rebates, returns and discounts $ 10,345 $ — Accrued bonuses 2,089 2,210 Accrued payroll and related benefits 1,762 1,217 Accrued incentive compensation 1,671 1,160 Accrued development costs 1,120 2,485 Accrued sales and marketing 1,076 801 Accrued other operating costs 792 572 Accrued audit and legal 404 416 Accrued interest 9 18 Total accrued expenses $ 19,268 $ 8,879 |
EQUITY
EQUITY | 9 Months Ended |
Sep. 30, 2017 | |
EQUITY | |
EQUITY | 8. Equity The changes in shareholders’ equity for the nine months ended September 30, 2017 were as follows: Additional Total Common Stock Paid- In Accumulated Shareholders’ Shares Amount Capital Deficit Equity (Deficit) Balance, December 31, 2016 29,364,100 $ 29 $ 358,063 $ (223,184) $ 134,908 Exercise of common stock options 131,755 1 427 — 428 Issuance for employee stock purchase plan 110,841 — 1,141 — 1,141 Vesting of restricted stock units 14,757 — — — — Shares withheld for employee taxes upon vesting of restricted stock units (4,819) — (68) — (68) Issuance of common stock resulting from at-the-market transactions, net of issuance costs of $507 1,148,466 1 11,454 — 11,455 Stock-based compensation — — 5,867 — 5,867 Net loss — — — (57,462) (57,462) Balance, September 30, 2017 30,765,100 $ 31 $ 376,884 $ (280,646) $ 96,269 |
STOCK BASED COMPENSATION
STOCK BASED COMPENSATION | 9 Months Ended |
Sep. 30, 2017 | |
STOCK BASED COMPENSATION | |
STOCK BASED COMPENSATION | 9. 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 Nine months ended September 30, September 30, 2017 2016 2017 2016 Research and development expenses $ 222 $ 171 $ 673 $ 474 Selling, general and administrative expenses 1,878 1,470 5,194 3,663 Total stock-based compensation expense $ 2,100 $ 1,641 $ 5,867 $ 4,137 At September 30, 2017, there was approximately $18,889 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 2.7 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 are 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 September 30, 2017, there were A summary of the Company’s restricted stock award activity for the nine months ended September 30, 2017 and related information is as follows: Weighted-Average Purchase Price Shares per Share Unvested at December 31, 2016 43,265 $ 5.73 Granted — — Vested (24,336) Unvested at September 30, 2017 (1) 18,929 $ (1) A summary of the Company’s restricted stock units activity for the nine months ended September 30, 2017 and related information is as follows: Weighted-Average Shares Grant Date Fair Value Outstanding at December 31, 2016 41,741 $ 16.15 Granted 211,018 12.45 Settled (14,757) 16.15 Forfeited (19,130) 15.52 Outstanding at September 30, 2017 218,872 $ 12.64 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, 2016 2,326,801 $ 8.7 $ 7,927 Granted 1,261,373 Exercised (131,755) Cancelled (399,465) Outstanding at September 30, 2017 3,056,954 $ $ 3,604 Exercisable at September 30, 2017 940,101 $ $ 1,727 Vested and expected to vest at September 30, 2017 2,909,114 $ $ 3,571 The fair value of each stock option is estimated on the grant date using the Black-Scholes option-pricing model using the following assumptions: Nine months ended September 30, 2017 2016 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 as designated by the Company’s Board of Directors 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 nine months ended September 30, 2017, 110,841 shares of common stock were purchased for total proceeds of $1,141. The expense for the three months ended September 30, 2017 and 2016 was $74 and $143, respectively. The expense for the nine months ended September 30, 2017 and 2016 was $288 and $311, respectively. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 9 Months Ended |
Sep. 30, 2017 | |
COMMITMENTS AND CONTINGENCIES | |
COMMITMENTS AND CONTINGENCIES | 10. 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. The Company’s NDA filing for Xtampza is 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. In connection with the 505(b)(2) process, the Company certified to the FDA and notified 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. Under the Hatch-Waxman Act of 1984 (the “Hatch-Waxman Act”), 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 regulatory approval for Xtampza, unless the stay was earlier terminated. Purdue exercised its option and elected to sue the Company for infringement in the District of Delaware in March 2015 asserting infringement of three of Purdue’s Orange Book ‑ listed patents and one non-Orange Book-listed patent. In October 2015, the Delaware case was transferred to 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 favor of the Company 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 obtained final approval of its Xtampza ER products and has launched the products 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. These suits were consolidated by the District of Massachusetts into the original action where Purdue’s infringement claim relating to the ’497 patent remains pending. Purdue continues to assert infringement of these three patents against the Company, none of which is associated with any stay of FDA approval. 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, and seeks a judgment that the case is exceptional, with an award to the Company of its fees for defending the case. In April 2017, Purdue filed another suit asserting infringement of U.S. Patent No. 9,522,919, related to the previously asserted ’933 patent, which recently issued and was late-listed in the Orange Book and therefore could not trigger any stay of FDA approval. Purdue has similarly made a demand for monetary relief and has requested judgment of infringement and an injunction on the sale of the Company’s accused products. The Company will oppose this action. In September 2017, Purdue filed another suit in the United States District Court, District of Massachusetts, asserting infringement of U.S. Patent No. 9,693,961 (the “’961” patent). The ʼ961 patent is not Orange Book-listed and is unrelated to the patents asserted in the lead case. Because the ʼ961 patent is not Orange Book-listed, it cannot trigger any stay of FDA approval. Purdue has similarly made a demand for monetary relief and has requested judgment of infringement and an injunction on the sale of the Company’s accused products. The Company has not yet filed an answer or otherwise responded to this Complaint. In October 2017, and in response to the filing of the Company’s supplemental New Drug Application (“NDA”), Purdue filed another suit in the United States District Court, District of Massachusetts, asserting infringement of the ʼ933 and ʼ919 patent. At this time, it is unclear if the suit will trigger an additional stay of FDA approval of the Company’s label change proposed by its supplemental NDA. The Company has not yet filed an answer or otherwise responded to this Complaint. Purdue continues to assert infringement of four remaining patents by the Company in the lead case, which are the ʼ919 patent, the ʼ933 patent, U.S. Patent No. 8,652,497, U.S. and U.S. Patent No. 9,155,717. The parties are in the early stages of fact discovery. Written discovery has commenced with depositions expected to commence in the fourth quarter of 2017. The parties are also in the claims construction stage of the patent litigation. The parties have briefed their proposed construction. The Company has also filed a motion for summary judgment that the asserted claims of the ’933, ’497, and ’717 patents are invalid and not infringed. The Court heard argument on the claims construction issues and on the Company’s summary judgment motion on June 1, 2017. The Company is not able to predict with certainty when the Court will decide claim construction or the Company’s motion. No trial date has been scheduled. The Company is, and plans to continue, defending this case vigorously. At this stage, we are unable to evaluate the likelihood of an unfavorable outcome or estimate the amount or range of potential loss, if any. At this time the Company is unable to provide meaningful quantification of how this potential litigation may impact its future financial condition, results of operations, or cash flows. |
SUMMARY OF SIGNIFICANT ACCOUN17
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 9 Months Ended |
Sep. 30, 2017 | |
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, a wholly-owned subsidiary 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 as of September 30, 2017, the results of operations for three and nine months ended September 30, 2017 and 2016 , and cash flows for the nine months ended September 30, 2017 and 2016. The results of operations for the three and nine months ended September 30, 2017 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 Xtampza, estimates utilized in the valuation of inventory, estimates of useful lives with respect to intangible assets, accounting for stock-based compensation, contingencies, intangible assets, tax valuation reserves and accrued expenses. 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. |
Revenue Recognition | Revenue Recognition Revenue for product sales is recognized when there is persuasive evidence of an arrangement, title and risk of loss have passed to the customer, which generally occurs upon delivery, and when estimated provisions for chargebacks, rebates, sales incentives and allowances, distribution service fees, and returns are reasonably determinable, and when collectability is reasonably assured. Product sales are recorded net of estimated chargebacks, rebates, sales incentives and allowances, distribution service fees, as well as estimated product returns. Beginning in the third quarter of 2017, the Company has determined that it has sufficient experience with sales of Xtampza to estimate its returns at time of shipment. The Company sells its products primarily to distributors and retailers (“customers”), which in turn sell the product to pharmacies for the treatment of patients. The Company provides the right of return to its customers for a limited time before and after its expiration date. As a result of its experience to date with Xtampza sales, the Company determined that it can reasonably estimate the amount of future product returns. The effect on income from operations and on net income is that the Company is able to recognize revenue earlier on the sell-in method, net of a provision for estimated returns, because the Company can record revenue once sold to the customer rather than waiting until the product is sold to the end user on a sell-through method. The Company recorded a one-time $4,377 increase to revenues during the three months ended September 30, 2017 as a result of the Company’s change to the sell-in method in the third quarter of 2017. |
Subsequent Events | Subsequent Events The Company considers events or transactions that occur after the balance sheet date but before the financial statements are issued to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure. Subsequent events have been evaluated through the date of issuance of these financial statements. |
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 $2,489 and $3,486 in the three months ended September 30, 2017 and 2016 respectively. Advertising and product promotion costs were $8,916 and $10,492 in the nine months ended September 30, 2017 and 2016 respectively. Advertising and product promotion costs are expensed as incurred. |
Recent Accounting Pronouncements | Recent 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 (ASC 606), Revenue from Contracts with Customers , which affects any entity that either enters into contracts with customers to transfer goods and services or enters into contracts for the transfer of nonfinancial assets. In August 2015, the FASB issued ASU 2015-14, Revenue from Contracts with Customers , which defers the effective date of ASU 2014-09 for all entities by one year. ASU 2014-09, which has been codified with the Accounting Standards Codification as Topic 606, is now effective for public companies for annual reporting periods beginning after December 15, 2017, including interim periods within those reporting periods. ASC 606 outlines a single comprehensive model for entities to use in accounting for revenue arising from contracts with customers and supersedes most current revenue recognition guidance, including industry-specific guidance. In addition, ASC 606 provides guidance on accounting for certain revenue-related costs including, but not limited to, when to capitalize costs associated with obtaining and fulfilling a contract. ASC 606 provides companies with two implementation methods. Companies can choose to apply the standard retrospectively to each prior reporting period presented (full retrospective application) or retrospectively with the cumulative effect of initially applying the standard as an adjustment to the opening balance of retained earnings of the annual reporting period that includes the date of initial application (modified retrospective application). Since ASU 2014-09 was issued, several additional ASUs have been issued and incorporated within ASC 606 to clarify various elements of the guidance. The Company will adopt the standard in the first quarter of 2018 using the modified retrospective method. The new standard differs from the current accounting standard in many respects, including the accounting for variable consideration. Under the Company’s current accounting policy, the Company recognizes product revenues and cost of product revenues at time of delivery to customers. The Company is still evaluating its contracts with customers and assessing the potential impacts of the new standard on existing arrangements. However, the Company does not expect the implementation of this guidance will have a material impact on its consolidated financial statements as the timing of revenue recognition for product sales is not expected to change significantly. 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 similar to existing guidance for operating leases today. 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. 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 amendments in these updates are effective for public business entities for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. The Company will adopt these standards in the first quarter of 2018 using the retrospective transition method as required with respect to each period presented. The Company expects the adoption of these standards will result in an increase in net cash provided by investing activities of $16 for the year ended December 31, 2015. The Company does not expect the adoption of these standards to have a material impact on its consolidated financial statements for the years ended December 31, 2016 or December 31, 2017 |
LOSS PER COMMON SHARE (Tables)
LOSS PER COMMON SHARE (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
LOSS PER COMMON SHARE | |
Schedule of computations of basic and diluted net loss per share | Three months ended September 30, Nine months ended September 30, 2017 2016 2017 2016 Loss attributable to common shareholders — basic and diluted $ (13,263) $ (26,444) $ (57,462) $ (66,617) Weighted-average number of common shares used in net loss per share - basic and diluted 29,753,043 23,460,340 29,517,396 23,334,558 Loss per share - basic and diluted $ (0.45) $ (1.13) $ (1.95) $ (2.85) |
Schedule of potentially dilutive securities excluded from computations of diluted weighted-average shares outstanding | Three months ended September 30, Nine months ended September 30, 2017 2016 2017 2016 Outstanding stock options 3,056,954 2,258,775 3,056,954 2,258,775 Warrants 2,445 2,445 2,445 2,445 Unvested restricted stock (1) 44,586 95,159 44,586 95,159 Restricted stock units 218,872 41,739 218,872 41,739 (1) - Includes shares of unvested restricted stock remaining from the early exercise of stock options. |
FAIR VALUE OF FINANCIAL INSTR19
FAIR VALUE OF FINANCIAL INSTRUMENTS (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
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 Description Total (Level 1) (Level 2) (Level 3) September 30, 2017 Money market funds, included in cash equivalents $ 81,026 $ 81,026 $ — $ — December 31, 2016 Money market funds, included in cash equivalents $ 125,515 $ 125,515 $ — $ — |
INVENTORY (Tables)
INVENTORY (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
INVENTORY | |
Schedule of Inventory | As of September 30, As of December 31, 2017 2016 Raw materials $ 599 $ 294 Work in process 168 67 Finished goods 634 955 Total inventory $ 1,401 $ 1,316 |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
ACCRUED EXPENSES | |
Schedule of components of accrued expenses | As of September 30, As of December 31, 2017 2016 Accrued rebates, returns and discounts $ 10,345 $ — Accrued bonuses 2,089 2,210 Accrued payroll and related benefits 1,762 1,217 Accrued incentive compensation 1,671 1,160 Accrued development costs 1,120 2,485 Accrued sales and marketing 1,076 801 Accrued other operating costs 792 572 Accrued audit and legal 404 416 Accrued interest 9 18 Total accrued expenses $ 19,268 $ 8,879 |
EQUITY (Tables)
EQUITY (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
EQUITY | |
Summary of Changes in Shareholders' Equity | Additional Total Common Stock Paid- In Accumulated Shareholders’ Shares Amount Capital Deficit Equity (Deficit) Balance, December 31, 2016 29,364,100 $ 29 $ 358,063 $ (223,184) $ 134,908 Exercise of common stock options 131,755 1 427 — 428 Issuance for employee stock purchase plan 110,841 — 1,141 — 1,141 Vesting of restricted stock units 14,757 — — — — Shares withheld for employee taxes upon vesting of restricted stock units (4,819) — (68) — (68) Issuance of common stock resulting from at-the-market transactions, net of issuance costs of $507 1,148,466 1 11,454 — 11,455 Stock-based compensation — — 5,867 — 5,867 Net loss — — — (57,462) (57,462) Balance, September 30, 2017 30,765,100 $ 31 $ 376,884 $ (280,646) $ 96,269 |
STOCK BASED COMPENSATION (Table
STOCK BASED COMPENSATION (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
STOCK BASED COMPENSATION | |
Summary of stock-based compensation included in statement of operations | Three months ended Nine months ended September 30, September 30, 2017 2016 2017 2016 Research and development expenses $ 222 $ 171 $ 673 $ 474 Selling, general and administrative expenses 1,878 1,470 5,194 3,663 Total stock-based compensation expense $ 2,100 $ 1,641 $ 5,867 $ 4,137 |
Summary of restricted stock awards activity | Weighted-Average Purchase Price Shares per Share Unvested at December 31, 2016 43,265 $ 5.73 Granted — — Vested (24,336) Unvested at September 30, 2017 (1) 18,929 $ (1) |
Summary of restricted stock units activity | Weighted-Average Shares Grant Date Fair Value Outstanding at December 31, 2016 41,741 $ 16.15 Granted 211,018 12.45 Settled (14,757) 16.15 Forfeited (19,130) 15.52 Outstanding at September 30, 2017 218,872 $ 12.64 |
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, 2016 2,326,801 $ 8.7 $ 7,927 Granted 1,261,373 Exercised (131,755) Cancelled (399,465) Outstanding at September 30, 2017 3,056,954 $ $ 3,604 Exercisable at September 30, 2017 940,101 $ $ 1,727 Vested and expected to vest at September 30, 2017 2,909,114 $ $ 3,571 |
Schedule of weighted-average assumptions used in Black-Scholes option-pricing model | Nine months ended September 30, 2017 2016 Risk-free interest rate % % Volatility % % Expected term (years) Expected dividend yield — % — % |
NATURE OF BUSINESS (Details)
NATURE OF BUSINESS (Details) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
NATURE OF BUSINESS | ||
Accumulated deficit | $ 280,646 | $ 223,184 |
SUMMARY OF SIGNIFICANT ACCOUN25
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Narrative (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||
Oct. 31, 2017 | Mar. 31, 2017 | Oct. 31, 2016 | Jan. 31, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2015 | |
Stock Issued During Period, Shares, New Issues | 5,750,000 | 2,750,000 | 1,148,466 | ||||||
Shares Issued, Price Per Share | $ 16 | $ 20 | $ 10.42 | $ 10.42 | |||||
Sale of Stock, Consideration Received on Transaction | $ 86,166,000 | $ 51,174,000 | $ 11,455,000 | ||||||
Sale of Stock, Consideration Received if Additional Shares are Issued | $ 60,000,000 | ||||||||
Commission fee percentage on gross proceeds from sale of ATM shares | 3.00% | ||||||||
Increase in revenue due to change in selling method | $ 4,377,000 | ||||||||
Marketing and Advertising Expense | $ 2,489,000 | $ 3,486,000 | 8,916,000 | $ 10,492,000 | |||||
Net cash used in investing activities | $ (818,000) | $ (2,636,000) | |||||||
Accounting Standards Update 2016-18 And 2016-15 [Member] | |||||||||
Net cash used in investing activities | $ 16,000 | ||||||||
Subsequent Event [Member] | |||||||||
Shares Issued, Price Per Share | $ 11.29 | ||||||||
Sale of Stock, Consideration Received on Transaction | $ 19,646,000 | ||||||||
Sale of Stock, Consideration Received if Additional Shares are Issued | $ 1,793,290 |
LOSS PER COMMON SHARE - Computa
LOSS PER COMMON SHARE - Computation of Earnings per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
LOSS PER COMMON SHARE | ||||
Net loss | $ (13,263) | $ (26,444) | $ (57,462) | $ (66,617) |
Loss attributable to common shareholders — basic and diluted | $ (13,263) | $ (26,444) | $ (57,462) | $ (66,617) |
Weighted-average number of common shares used in net loss per share - basic and diluted | 29,753,043 | 23,460,340 | 29,517,396 | 23,334,558 |
Loss per share - basic and diluted | $ (0.45) | $ (1.13) | $ (1.95) | $ (2.85) |
LOSS PER COMMON SHARE - Summary
LOSS PER COMMON SHARE - Summary of Potentially Dilutive Securities (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Stock options | ||||
Anti-dilutive securities | ||||
Potentially dilutive securities excluded from the computations of diluted weighted-average shares outstanding | 3,056,954 | 2,258,775 | 3,056,954 | 2,258,775 |
Warrants | ||||
Anti-dilutive securities | ||||
Potentially dilutive securities excluded from the computations of diluted weighted-average shares outstanding | 2,445 | 2,445 | 2,445 | 2,445 |
Unvested restricted stock | ||||
Anti-dilutive securities | ||||
Potentially dilutive securities excluded from the computations of diluted weighted-average shares outstanding | 44,586 | 95,159 | 44,586 | 95,159 |
Restricted stock units | ||||
Anti-dilutive securities | ||||
Potentially dilutive securities excluded from the computations of diluted weighted-average shares outstanding | 218,872 | 41,739 | 218,872 | 41,739 |
FAIR VALUE OF FINANCIAL INSTR28
FAIR VALUE OF FINANCIAL INSTRUMENTS (Details) - Estimate of fair value - Recurring - Money market funds - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Cash equivalents | $ 81,026 | $ 125,515 |
Quoted Prices in active markets (Level 1) | ||
Cash equivalents | $ 81,026 | $ 125,515 |
INVENTORY (Details)
INVENTORY (Details) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
INVENTORY | ||
Raw materials | $ 599 | $ 294 |
Work in process | 168 | 67 |
Finished goods | 634 | 955 |
Total inventory | $ 1,401 | $ 1,316 |
INTANGIBLE ASSETS (Details)
INTANGIBLE ASSETS (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||
Mar. 31, 2017 | May 31, 2016 | Sep. 30, 2017 | Mar. 31, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
INTANGIBLE ASSETS | |||||||
Milestone payments payable contingent on the satisfaction of certain commercialization, intellectual property, and net sales milestones | $ 21,000 | ||||||
Milestone payment contingent on the first commercial sale of the product in the U.S. | 4,000 | ||||||
Upfront payment classified as an intangible asset | 2,500 | ||||||
Maximum reimbursement amount for out-of-pocket expenses | $ 2,000 | ||||||
Out-Of-Pocket Expenses Reimbursed | $ 1,391 | ||||||
Remaining amortization period | 11 years 2 months 12 days | 3 years 8 months 12 days | 9 years 9 months 18 days | ||||
Amortization expense | $ 48 | $ 227 | $ 225 | $ 227 | |||
Estimated amortization for 2017 | 47 | 47 | |||||
Estimated amortization for 2018 | 191 | 191 | |||||
Estimated amortization for 2019 | 191 | 191 | |||||
Estimated amortization for 2020 | 191 | 191 | |||||
Estimated amortization for 2021 | 191 | 191 | |||||
Estimated amortization thereafter | $ 1,066 | $ 1,066 |
ACCRUED EXPENSES (Details)
ACCRUED EXPENSES (Details) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
ACCRUED EXPENSES | ||
Accrued rebates, returns and discounts | $ 10,345 | |
Accrued bonuses | 2,089 | $ 2,210 |
Accrued payroll and related benefits | 1,762 | 1,217 |
Accrued incentive compensation | 1,671 | 1,160 |
Accrued development costs | 1,120 | 2,485 |
Accrued sales and marketing | 1,076 | 801 |
Accrued other operating costs | 792 | 572 |
Accrued audit and legal | 404 | 416 |
Accrued interest | 9 | 18 |
Total accrued expenses | $ 19,268 | $ 8,879 |
EQUITY - Changes in Shareholder
EQUITY - Changes in Shareholders' Equity (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
Oct. 31, 2016 | Jan. 31, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Balance at beginning of period | $ 134,908 | |||||
Exercise of common stock options | $ 428 | |||||
Exercise of common stock options, shares | 131,755 | |||||
Issuance for employee stock purchase plan | $ 1,141 | |||||
Issuance for employee stock purchase plan, shares | 110,841 | |||||
Shares withheld for employee taxes upon vesting of restricted stock units | $ (68) | |||||
Issuance of common stock resulting from at-the-market transactions, net of issuance costs of $507 | $ 11,455 | |||||
Issuance of common stock resulting from at-the-market transactions, net of issuance costs of $507 (in shares) | 5,750,000 | 2,750,000 | 1,148,466 | |||
Stock-based compensation expense | $ 5,867 | |||||
Net loss | $ (13,263) | $ (26,444) | (57,462) | $ (66,617) | ||
Balance at end of period | 96,269 | 96,269 | ||||
Issuance costs | 507 | $ 526 | ||||
Common Stock | ||||||
Balance at beginning of period | $ 29 | |||||
Balance at beginning of year, shares | 29,364,100 | |||||
Exercise of common stock options | $ 1 | |||||
Exercise of common stock options, shares | 131,755 | |||||
Issuance for employee stock purchase plan, shares | 110,841 | |||||
Shares withheld for employee taxes upon vesting of restricted stock units, shares | (4,819) | |||||
Issuance of common stock resulting from at-the-market transactions, net of issuance costs of $507 | $ 1 | |||||
Issuance of common stock resulting from at-the-market transactions, net of issuance costs of $507 (in shares) | 1,148,466 | |||||
Vesting of restricted stock units, shares | 14,757 | |||||
Balance at end of period | $ 31 | $ 31 | ||||
Balance at end of year, shares | 30,765,100 | 30,765,100 | ||||
Additional Paid-In Capital | ||||||
Balance at beginning of period | $ 358,063 | |||||
Exercise of common stock options | 427 | |||||
Issuance for employee stock purchase plan | 1,141 | |||||
Shares withheld for employee taxes upon vesting of restricted stock units | (68) | |||||
Issuance of common stock resulting from at-the-market transactions, net of issuance costs of $507 | 11,454 | |||||
Stock-based compensation expense | 5,867 | |||||
Balance at end of period | $ 376,884 | 376,884 | ||||
Accumulated Deficit | ||||||
Balance at beginning of period | (223,184) | |||||
Net loss | (57,462) | |||||
Balance at end of period | $ (280,646) | $ (280,646) |
STOCK BASED COMPENSATION - Narr
STOCK BASED COMPENSATION - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2016 | May 31, 2015 | |
Stock-based compensation | ||||||
Unrecognized compensation cost related to outstanding options | $ 18,889 | $ 18,889 | ||||
Shares of common stock authorized for issuance outstanding (in shares) | 3,056,954 | 3,056,954 | 2,326,801 | |||
Employee Stock Purchase Plan, Purchase Price Percentage | 85.00% | |||||
Issuance for employee stock purchase plan, shares | 110,841 | |||||
Proceeds from issuances of common stock from employee stock purchase plans | $ 1,141 | |||||
Employee Stock Purchase Plan, Compensation Expense | $ 74 | $ 143 | $ 288 | $ 311 | ||
Stock options | ||||||
Stock-based compensation | ||||||
Period over which unrecognized compensation cost is expected to be recognized as expense | 2 years 8 months 12 days | |||||
2014 Stock Incentive Plan | ||||||
Stock-based compensation | ||||||
Shares of common stock authorized for issuance (in shares) | 2,700,000 | |||||
Share of common stock remaining available for future grant | 1,142,277 | 1,142,277 | ||||
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 | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Stock-based compensation | ||||
Total stock-based compensation expense | $ 2,100 | $ 1,641 | $ 5,867 | $ 4,137 |
Research and development expenses | ||||
Stock-based compensation | ||||
Total stock-based compensation expense | 222 | 171 | 673 | 474 |
Selling, general and administrative expenses | ||||
Stock-based compensation | ||||
Total stock-based compensation expense | $ 1,878 | $ 1,470 | $ 5,194 | $ 3,663 |
STOCK BASED COMPENSATION - Su35
STOCK BASED COMPENSATION - Summary of Restricted Stock Award Activity (Details) - Restricted Stock Awards | 9 Months Ended |
Sep. 30, 2017$ / sharesshares | |
Restricted stock awards | |
Balance | 43,265 |
Vested/Settled | (24,336) |
Balance | 18,929 |
Unvested remaining from the early exercise of stock options (in shares) | 25,657 |
Weighted-average purchase price per share | |
Balance | $ / shares | $ 5.73 |
Vested/Settled | $ / shares | 5.73 |
Balance | $ / shares | $ 5.73 |
STOCK BASED COMPENSATION - Su36
STOCK BASED COMPENSATION - Summary of Restricted Stock Units (RSUs) Activity (Details) - Restricted stock units | 9 Months Ended |
Sep. 30, 2017$ / sharesshares | |
Restricted stock awards | |
Balance | shares | 41,741 |
Granted | shares | 211,018 |
Vested/Settled | shares | (14,757) |
Forfeited | shares | (19,130) |
Balance | shares | 218,872 |
Weighted-average purchase price per share | |
Balance | $ / shares | $ 16.15 |
Granted | $ / shares | 12.45 |
Vested/Settled | $ / shares | 16.15 |
Forfeited | $ / shares | 15.52 |
Balance | $ / shares | $ 12.64 |
STOCK BASED COMPENSATION - Su37
STOCK BASED COMPENSATION - Summary of Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2017 | Dec. 31, 2016 | |
Stock option activity | ||
Outstanding | 2,326,801 | |
Granted | 1,261,373 | |
Exercised | (131,755) | |
Cancelled | (399,465) | |
Outstanding | 3,056,954 | 2,326,801 |
Exercisable at end of period | 940,101 | |
Vested and expected to vest at end of period | 2,909,114 | |
Weighted average exercise price per share | ||
Outstanding | $ 13.07 | |
Granted | 12.06 | |
Exercised | 3.25 | |
Cancelled | 13.62 | |
Outstanding | 13 | $ 13.07 |
Exercisable at end of period | 12.80 | |
Vested and expected to vest at end of period | $ 13.08 | |
Stock option activity, additional information | ||
Outstanding Weighted-Average Remaining Contractual Term | 8 years 7 months 6 days | 8 years 8 months 12 days |
Outstanding Aggregate Intrinsic Value | $ 3,604 | $ 7,927 |
Exercisable at end of period, Weighted-Average Remaining Contractual Term | 7 years 9 months 18 days | |
Exercisable at end of period, Aggregate Intrinsic Value | $ 1,727 | |
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 | $ 3,571 |
STOCK BASED COMPENSATION - Su38
STOCK BASED COMPENSATION - Summary of Valuation Assumptions Used (Details) | 9 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
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 | 2.00% | 1.50% |
Volatility | 71.00% | 77.00% |
Expected term (in years) | 6 years 4 days | 6 years 7 days |
Dividend yield |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Details) - patent | 1 Months Ended | 9 Months Ended |
Oct. 31, 2017 | Sep. 30, 2017 | |
Purdue Pharma, L. P. patent infringement suits | ||
Contingencies | ||
Total number of Orange Book patents asserted to have been infringed | 3 | |
Total number of non-Orange Book patents asserted to have been infringed | 1 | |
Purdue Pharma, L. P. patent infringement suits | Maximum | ||
Contingencies | ||
Stay period before FDA can issue a final approval unless it is terminated | 30 months | |
Purdue Pharma, L. P. patent infringement suit, District of Massachusetts | ||
Contingencies | ||
Total number of patents asserted to have been infringed | 4 |