Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2015 | Oct. 31, 2015 | |
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, 2015 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Common Stock, Shares Outstanding | 20,688,914 | |
Document Fiscal Year Focus | 2,015 | |
Document Fiscal Period Focus | Q3 |
BALANCE SHEETS
BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
Current assets: | ||
Cash and cash equivalents | $ 105,460 | $ 1,634 |
Refundable PDUFA fee | 2,335 | |
Prepaid expenses and other current assets | 866 | 527 |
Total current assets | 106,326 | 4,496 |
Property and equipment, net | 627 | 514 |
Restricted cash | 97 | 80 |
Total assets | 107,050 | 5,090 |
Current liabilities: | ||
Accounts payable | 3,237 | 2,208 |
Accrued expenses | 2,681 | 1,956 |
Current portion of deferred rent and lease note payable | 15 | 59 |
Current portion of term loan payable | 2,667 | 1,194 |
Convertible bridge notes with related parties | 5,000 | |
Total current liabilities | 8,600 | 10,417 |
Lease incentive obligation | 76 | 101 |
Term loan payable, long-term | 4,813 | 6,813 |
Total liabilities | $ 13,489 | $ 17,331 |
Commitments and contingencies (See Note 9) | ||
Shareholders’ equity (deficit): | ||
Common stock, $0.001 par value; authorized shares - 100,000,000 at September 30, 2015 and 72,000,000 at December 31, 2014; issued and outstanding shares - 20,687,829 at September 30, 2015 and 1,006,219 at December 31, 2014 | $ 20 | $ 1 |
Additional paid-in capital | 213,027 | 12,407 |
Accumulated deficit | (119,483) | (101,753) |
Treasury stock | (3) | (3) |
Total shareholders' equity (deficit) | 93,561 | (89,348) |
Total liabilities, convertible redeemable preferred stock and shareholders' equity (deficit) | $ 107,050 | 5,090 |
Series A convertible redeemable preferred stock | ||
Convertible redeemable preferred stock | ||
Convertible redeemable preferred stock | 12,781 | |
Series B convertible redeemable preferred stock | ||
Convertible redeemable preferred stock | ||
Convertible redeemable preferred stock | 51,212 | |
Series C convertible redeemable preferred stock | ||
Convertible redeemable preferred stock | ||
Convertible redeemable preferred stock | $ 13,114 |
BALANCE SHEETS (Parenthetical)
BALANCE SHEETS (Parenthetical) - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, authorized shares | 100,000,000 | 72,000,000 |
Common stock, issued shares | 20,687,829 | 1,006,219 |
Common stock, outstanding shares | 20,687,829 | 1,006,219 |
Series A convertible redeemable preferred stock | ||
Convertible redeemable preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Convertible redeemable preferred stock, authorized shares | 0 | 18,498,419 |
Convertible redeemable preferred stock, issued shares | 0 | 9,232,334 |
Convertible redeemable preferred stock, outstanding shares | 0 | 9,232,334 |
Convertible redeemable preferred stock, liquidation preference | $ 0 | $ 12,781 |
Series B convertible redeemable preferred stock | ||
Convertible redeemable preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Convertible redeemable preferred stock, authorized shares | 0 | 27,324,237 |
Convertible redeemable preferred stock, issued shares | 0 | 27,324,237 |
Convertible redeemable preferred stock, outstanding shares | 0 | 27,324,237 |
Convertible redeemable preferred stock, liquidation preference | $ 0 | $ 51,212 |
Series C convertible redeemable preferred stock | ||
Convertible redeemable preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Convertible redeemable preferred stock, authorized shares | 0 | 8,658,344 |
Convertible redeemable preferred stock, issued shares | 0 | 8,658,008 |
Convertible redeemable preferred stock, outstanding shares | 0 | 0 |
Convertible redeemable preferred stock, liquidation preference | $ 0 | $ 13,114 |
Series D convertible redeemable preferred stock | ||
Convertible redeemable preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Convertible redeemable preferred stock, authorized shares | 0 | 0 |
Convertible redeemable preferred stock, issued shares | 0 | 0 |
Convertible redeemable preferred stock, outstanding shares | 0 | 0 |
Convertible redeemable preferred stock, liquidation preference | $ 0 | $ 0 |
STATEMENTS OF OPERATIONS
STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Operating expenses: | ||||
Research and development | $ 3,358 | $ 5,818 | $ 6,444 | $ 12,652 |
General and administrative | 5,907 | 687 | 11,027 | 1,686 |
Total operating expenses | 9,265 | 6,505 | 17,471 | 14,338 |
Loss from operations | (9,265) | (6,505) | (17,471) | (14,338) |
Other expense: | ||||
Interest expense, net | 97 | 51 | 350 | 110 |
Gain on extinguishment | (91) | |||
Total other expense, net | 97 | 51 | 259 | 110 |
Net loss | $ (9,362) | $ (6,556) | $ (17,730) | $ (14,448) |
Net loss per share - basic and diluted (in dollars per share) | $ (0.46) | $ (7.85) | $ (0.94) | $ (18.26) |
Weighted-average number of common shares used in net loss per share-basic and diluted (in shares) | 20,531,406 | 940,627 | 11,179,756 | 926,597 |
STATEMENTS OF CASH FLOWS
STATEMENTS OF CASH FLOWS - USD ($) | 9 Months Ended | |
Sep. 30, 2015 | Sep. 30, 2014 | |
Operating activities | ||
Net loss | $ (17,730,000) | $ (14,448,000) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 130,000 | 141,000 |
Lease incentive | (25,000) | (25,000) |
Stock-based compensation expense | 1,217,000 | 16,000 |
Non cash interest expense | 6,000 | 6,000 |
Accrual of back end fees related to note payable | (12,000) | |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (338,000) | (139,000) |
Refundable PDUFA fee | 2,335,000 | |
Accounts payable | 962,000 | 1,563,000 |
Accrued expenses | 815,000 | 2,518,000 |
Net cash used in operating activities | (12,628,000) | (10,380,000) |
Investing activities | ||
Purchases of property and equipment | (175,000) | |
Net cash used in investing activities | (175,000) | |
Financing activities | ||
(Repayment of) borrowing from term note | (619,000) | 7,044,000 |
Repayment of lease note payable | (44,000) | (46,000) |
Restricted cash | (16,000) | |
Proceeds from the exercise of stock options | 472,000 | 9,000 |
Net cash provided by financing activities | 116,629,000 | 7,007,000 |
Net increase (decrease) in cash and cash equivalents | 103,826,000 | (3,373,000) |
Cash and cash equivalents at beginning of period | 1,634,000 | 7,551,000 |
Cash and cash equivalents at end of period | 105,460,000 | 4,178,000 |
Supplemental disclosure of noncash activities | ||
Accruals of dividends and accretion to redemption value | 24,572,000 | 2,469,000 |
Conversion of bridge note to preferred stock | 5,000,000 | |
Cash paid for interest | 260,000 | 46,000 |
Cash paid for taxes | 4,000 | |
Repayment of term note with proceeds of notes payable | $ 944,000 | |
Common stock | ||
Financing activities | ||
Proceeds from issuance of stock, net of issuance costs | 72,029,000 | |
Series D convertible redeemable preferred stock | ||
Financing activities | ||
Proceeds from issuance of stock, net of issuance costs | 44,807,000 | |
Supplemental disclosure of noncash activities | ||
Accruals of dividends and accretion to redemption value | 24,572,000 | |
Conversion of redeemable convertible preferred stock into common stock | All series of convertible redeemable preferred stock | ||
Supplemental disclosure of noncash activities | ||
Preferred stock conversion to common stock | $ 120,302,000 |
STATEMENTS OF CASH FLOWS (Paren
STATEMENTS OF CASH FLOWS (Parenthetical) $ in Thousands | 9 Months Ended |
Sep. 30, 2015USD ($) | |
Common stock | |
Preferred stock | |
Stock issuance costs | $ 2,408 |
Series D convertible redeemable preferred stock | |
Preferred stock | |
Stock issuance costs | $ 193 |
Nature of Business
Nature of Business | 9 Months Ended |
Sep. 30, 2015 | |
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 planning to commercialize next-generation abuse-deterrent products that incorporate the Company’s patented DETERx® platform technology for the treatment of chronic pain and other diseases. The Company’s lead product candidate, Xtampza ER ™ , or Xtampza, is an abuse-deterrent, extended-release, oral formulation of oxycodone, a widely prescribed opioid medication. Xtampza has received Fast Track status from the U.S. Food and Drug Administration (‘‘FDA’’). The Company’s new drug application (‘‘NDA’’) filing for Xtampza was accepted by the FDA on February 10, 2015. On February 25, 2015, the FDA set a Prescription Drug User Fee Act, or PDUFA, goal date of October 12, 2015 for completion of its review of the Xtampza NDA. On November 6, 2015, the FDA granted tentative approval to the Xtampza NDA 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. With a tentative approval, the FDA has determined that Xtampza meets the required quality, safety and efficacy standards for approval but that it is subject to an automatic stay of up to 30 months as a result of patent litigation filed by Purdue Pharma, L.P (Purdue) in March 2015. The Company’s operations are subject to certain risks and uncertainties. The principal risks include negative outcome of clinical trials, inability or delay in completing clinical trials or obtaining regulatory approvals, changing market conditions for products being developed by the Company, 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. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2015 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 2. Summary of Significant Accounting Policies Basis of presentation The accompanying unaudited condensed 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 management, all adjustments (including those which are normal and recurring) considered necessary for a fair presentation of the interim financial information have been included. When preparing financial statements in conformity with GAAP, the Company must make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, expenses and related disclosures at the date of the financial statements. Actual results could differ from those estimates. Additionally, operating results for the interim periods ended September 30, 2015 and 2014 are not necessarily indicative of the results that may be expected for any other interim period or for the full year. The condensed interim financial statements should be read in conjunction with the audited financial statements and notes thereto included in the Company’s Prospectus dated May 6, 2015 (“Prospectus”) filed pursuant to Rule 424 (b) (4) under the Securities Act of 1933, as amended, with the Securities and Exchange Commission (“SEC”) on May 7, 2015 in conjunction with the Company’s initial public offering of common stock. Initial Public Offering In May 2015, the Company closed an initial public offering (“IPO”) of its common stock, which resulted in the sale of 6,670,000 shares of its common stock at a public offering price of $12.00 per share, including 870,000 shares of common stock upon the exercise by the underwriters of their option to purchase additional shares at the public offering price. The Company received proceeds from the IPO of approximately $72 ,029 , after deducting underwriting discounts, commissions and expenses payable by the Company. In connection with preparing for the IPO, the Company’s Board of Directors and shareholders approved a one -for-6.9 reverse stock split of the Company’s common stock. The reverse stock split became effective in April 2015. All share and per share amounts in the condensed interim financial statements and notes thereto have been retroactively adjusted for all periods presented to give effect to this reverse stock split, including reclassifying an amount equal to the reduction in par value of common stock to additional paid-in capital. In connection with the closing of the IPO, all of the Company’s outstanding convertible preferred stock automatically converted to common stock in May 2015, resulting in an additional 12,591,456 shares of common stock of the Company becoming outstanding. The significant increase in common stock outstanding in May 2015 is expected to impact the year-over-year comparability of the Company’s net loss per share calculations in future periods. Subsequent Events The Company considers events or transactions that occur after the balance sheet date but prior to the issuance of the financial statements to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure. Through the date of the filing of this Form 10-Q, the Company has concluded that no subsequent events have occurred that require disclosure, except as described in Note 9. Critical Accounting Policies Earnings (Loss) per Common Share Earnings (loss) per common share is calculated using the two-class method, which is an earnings allocation formula that determines earnings (loss) per share for the holders of the Company’s common shares and participating securities. All series of preferred stock contain participation rights in any dividend paid by the Company and are deemed to be participating securities. Earnings available to common shareholders and participating convertible redeemable preferred shares is allocated first to the preferred stock based upon the distribution criteria in the Company’s Articles of Incorporation then the remainder to the common shareholders. The participating securities do not include a contractual obligation to share in losses of the Company and are not included in the calculation of net loss per share in the periods that have a net loss. Diluted earnings per share is computed using the more dilutive of (a) the two-class method, or (b) the if-converted method. The Company allocates earnings first to preferred shareholders based on dividend rights and then to common and preferred shareholders based on ownership interests. The weighted-average number of common shares included in the computation of diluted earnings (loss) gives effect to all potentially dilutive common equivalent shares, including outstanding stock options, warrants, convertible redeemable preferred stock and the potential issuance of stock upon the conversion of the Company’s convertible notes. Common stock equivalent shares are excluded from the computation of diluted earnings (loss) per share if their effect is antidilutive. Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board (“FASB”), issued Accounting Standards Update (“ASU”), No. 2014-09, which amends the guidance for accounting for revenue from contracts with customers. This ASU supersedes the revenue recognition requirements in Accounting Standards Codification (“ASC”), Topic 605, Revenue Recognition, and creates a new Topic 606, Revenue from Contracts with Customers. Two adoption methods are permitted: retrospectively to all prior reporting periods presented, with certain practical expedients permitted; or retrospectively with the cumulative effect of initially adopting the ASU recognized at the date of initial application. On August 12, 2015, the FASB issued ASU No. 2015-14, which defers the effective date of ASU No. 2014-09 by one year to December 15, 2017 for annual reporting periods beginning after that date, including interim periods within those periods. The FASB also approved permitting early adoption of the standard, but not before the original effective date of December 15, 2016. The Company has not yet determined which adoption method it will utilize or the effect that the adoption of this guidance will have on its financial statements. In July 2015, the FASB issued ASU No. 2015-11, which amends existing guidance for measurement of inventory. Current inventory guidance requires an entity to measure inventory at the lower of cost or market. Market could be replacement cost, net realizable value, or net realizable value less an approximately normal profit margin. The amendments do not apply to inventory that is measured using last-in, first-out (LIFO) or the retail inventory method. The amendments apply to all other inventory, which includes inventory that is measured using first-in, first-out or average cost. An entity should measure all inventory to which the amendments apply at the lower of cost and net realizable value. Net realizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. Subsequent measurement is unchanged for inventory measured using LIFO or the retail inventory method. The amendments in the ASU No. 2015-11 more closely align the measurement of inventory pursuant to GAAP with the measurement of inventory pursuant to International Financial Reporting Standards. The amendments are effective for fiscal years beginning after December 15, 2016, and interim periods within fiscal years beginning after December 15, 2017. The amendments should be applied prospectively with earlier application permitted as of the beginning of an interim or annual reporting period. The Company does not expect the adoption of this guidance to have a material impact on its condensed financial statements. |
Net Loss per Common Share
Net Loss per Common Share | 9 Months Ended |
Sep. 30, 2015 | |
NET LOSS PER COMMON SHARE | |
NET LOSS PER COMMON SHARE | 3. Net Loss per Common Share Three months ended Nine months ended September 30, September 30, 2015 2014 2015 2014 Net loss $ $ $ $ Extinguishment of preferred stock - see note 7 — — — Accretion of prior preferred stock - see note 7 — Accretion and dividends of Series D preferred stock — — — Loss attributable to common shareholders — basic and diluted $ $ $ $ Weighted-average number of common shares used in net loss per share—basic and diluted Net loss per share—basic and diluted $ $ $ $ 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 Nine months ended September 30, September 30, 2015 2014 2015 2014 Outstanding stock options Warrants Redeemable convertible preferred stock - - Unvested restricted stock |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 9 Months Ended |
Sep. 30, 2015 | |
Fair Value of Financial Instruments | |
Fair Value of Financial Instruments | 4. Fair Value of Financial Instruments The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. The fair value hierarchy is now established that prioritizes valuation inputs based on the observable nature of those inputs. The fair value hierarchy applies only to the valuation inputs used in determining the reported fair value of the investments and is not a measure of the investment credit quality. The hierarchy defines three levels of valuation inputs: Level 1 inputs Quoted prices 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 September 30, 2015 and December 31, 2014. Significant Quoted Prices other Significant in active observable unobservable markets inputs inputs Description Total (Level 1) (Level 2) (Level 3) September 30, 2015 Money market funds, included in cash equivalents $ $ $ — $ — December 31, 2014 Money market funds, included in cash equivalents $ $ $ — $ — The Company’s cash equivalents are comprised of money market funds that are measured on a recurring basis based on quoted market prices. |
Accrued Expenses
Accrued Expenses | 9 Months Ended |
Sep. 30, 2015 | |
ACCRUED EXPENSES | |
ACCRUED EXPENSES | 5. Accrued Expenses Accrued expenses consisted of the following: September 30, 2015 December 31, 2014 Accrued compensation $ $ Accrued development costs Accrued marketing — Accrued audit and legal Accrued interest Accrued other Total accrued expenses $ $ |
Convertible Bridge Note with Re
Convertible Bridge Note with Related Party | 9 Months Ended |
Sep. 30, 2015 | |
Convertible Bridge Note with Related Party | |
Convertible Bridge Note with Related Party | 6. Convertible Bridge Note with Related Party In November and December 2014, the Company entered into a Note Purchase Agreement (the "Bridge Notes") allowing for the issuance of $5,000 of convertible promissory notes to a group of investors (the "Holders") bearing interest at a rate per annum of 6.0% . The Holders are related parties of the Company. In connection with the Series D convertible preferred stock financing (see note 7), the Bridge Notes converted into Series D convertible preferred stock. Upon the conversion, the Company recognized a gain on extinguishment of $91 . |
Convertible Preferred Stock
Convertible Preferred Stock | 9 Months Ended |
Sep. 30, 2015 | |
Convertible Preferred Stock | |
Convertible Preferred Stock | 7. Convertible Preferred Stock In March 2015, the Company issued and sold an aggregate of 41,666,667 shares of Series D convertible preferred stock for aggregate consideration of $50,000 , comprised of $45,000 in cash and conversion of $5,000 in Bridge Notes. The accrued interest on the convertible notes was waived. Concurrently with the issuance of the Series D Preferred Stock, the Company amended and restated its Articles of Incorporation (the “Amended Articles”). The Company made certain amendments to the terms of the Series A, Series B , and Series C Preferred Stock (together, the “Prior Preferred Stock”). Prior to the adoption of the Amended Articles, the Series A, Series B, and Series C Preferred Stock accrued dividends at a rate of 4.5% , 8.0% and 8.0% per annum, respectively, per share. All accrued and unpaid dividends on the Prior Preferred Stock were automatically cancelled and forfeited and the Prior Preferred Stock no longer accrued dividends. Prior to the cancellation and forfeiture of accrued dividends, the Prior Preferred Stock had accrued dividends of $622 during 2015. The holders of outstanding shares of Prior Preferred Stock were entitled to receive dividends, when, as and if declared by the Board of Directors. The mandatory conversion for all series of Prior Preferred Stock was modified so as to occur upon an initial public offering with gross proceeds in excess of $50,000 . The amendments to the Prior Preferred Stock were treated as an extinguishment which resulted in a gain on extinguishment of $31,806 . The gain on extinguishment was added to net loss to arrive at income available to common shareholders in the calculation of earnings per share. During the nine months and three months ended September 30, 2015, total accrued dividends and accretion for preferred stock was $24,572 and none , respectively. In connection with the closing of the IPO, all of the Company’s outstanding convertible preferred stock automatically converted to common stock in May 2015, resulting in an additional 12,591,456 shares of common stock of the Company becoming outstanding. |
Stock-based Compensation
Stock-based Compensation | 9 Months Ended |
Sep. 30, 2015 | |
STOCK BASED COMPENSATION | |
STOCK BASED COMPENSATION | 8. Stock-based Compensation In July 2014, the Company adopted the 2014 Stock Incentive Plan (the "Plan"), under which 525,700 shares of common stock are authorized for issuance to employees, officers, directors, consultants and advisors of the Company. In connection with the Company's reincorporation into Virginia in July 2014, each outstanding option to purchase shares of common stock under the Company’s 2012 Stock Incentive Plan and 2002 Stock Plan, was automatically terminated and replaced with an option to purchase shares of common stock under the Plan having the same vesting terms and exercise price as the option that was replaced. The Plan provides for granting of both Internal Revenue Service qualified incentive stock options ("ISOs") and non-qualified options ("NQs"), restricted stock awards ("RSAs") and restricted stock units ("RSUs"). Stock options generally vest over a four year period of service; however, certain options contain performance conditions. The options generally have a ten year contractual life and, upon termination, vested options are generally exercisable between one and three months following the termination date, while unvested options are forfeited immediately. In April 2015, the Plan was amended to increase the maximum number of shares of common stock that may be issued to 2,700,000 shares. In addition, an “evergreen provision” was added to the Plan that allows for an annual increase in the number of shares of common stock available for issuance under the Plan. The annual increase will be added on the first day of each fiscal year beginning with the fiscal year ending December 31, 2016, and on each anniversary thereof until the expiration of the Plan equal to 4% of the outstanding shares of our common stock on December 31st of the immediately preceding fiscal year (or such lesser number of shares of common stock as determined by the board of directors). Restricted common stock A summary of the Company’s restricted stock activity for the nine months ended September 30, 2015 and related information is as follows: Weighted average purchase price Shares per share Unvested at December 31, 2014 $ Granted Vested Unvested at September 30, 2015 (1) $ (1) Excludes 72,463 shares of unvested restricted stock remaining from the early exercise of stock options as of September 30, 2015. Stock options 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 (years) Value Outstanding at December 31, 2014 $ Granted Exercised Cancelled Outstanding at September 30, 2015 $ $ Exercisable at September 30, 2015 $ $ Vested and expected to vest at September 30, 2015 $ $ 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, 2015 2014 Risk-free interest rate % % Dividend yield - - Volatility % % Expected term (years) |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2015 | |
COMMITMENTS AND CONTINGENCIES. | |
COMMITMENTS AND CONTINGENCIES | 9. Commitments and Contingencies 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 can elect to sue the Company for infringement, and if they do, receive a stay of up to 30 months before the FDA can issue a final approval for Xtampza, unless the stay is earlier terminated. On March 24, 2015, Purdue sued the Company in the District of Delaware asserting infringement of four patents. On March 26, 2015, Purdue filed a second suit against the Company in the District of Massachusetts asserting infringement of the same four patents. On July 23, 2015, Purdue voluntarily dismissed the Massachusetts suit. On August 6, 2015, the Delaware court dismissed the suit in Delaware and issued a memorandum opinion finding the Delaware court lacks personal jurisdiction over the Company Following the dismissal in Delaware, on August 6, 2015, the Company filed a complaint in the Southern District of New York asserting an action to obtain patent certainty, and requesting that the New York court find that Xtampza will not infringe any valid patent claim of the patents asserted by Purdue in the Delaware action. Also on August 6, 2015, Purdue sued the Company in the District of Massachusetts asserting the same claims as the prior suit. On August 7, 2015, Purdue filed a motion in the Delaware court requesting reconsideration of the August 6, 2015 order that dismissed the case. In the motion requesting reconsideration, Purdue asked that the Delaware court find that it does have personal jurisdiction over the Company and then transfer the case to the District of Massachusetts. On October 7, 2015, the Delaware court transferred the case to the District of Massachusetts. On November 9, 2015, the Company filed a motion for summary judgment, for which it requested expedited hearing in Massachusetts. At this time the Company is unable to provide meaningful quantification of how this litigation may impact its future financial condition, results of operations, or cash flows. In March 2015, the Company amended its lease to include an additional 9,660 square feet of space for a total of 19,335 square feet. In addition, the lease term was extended and now terminates on the date that is 5 years following August 2015 which is the date that the landlord delivered the expansion space with certain improvements substantially completed. At the Company’s election, the lease term may be extended for an additional 5 ‐ year term. |
Summary of Significant Accoun16
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2015 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Basis of presentation | Basis of presentation The accompanying unaudited condensed 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 management, all adjustments (including those which are normal and recurring) considered necessary for a fair presentation of the interim financial information have been included. When preparing financial statements in conformity with GAAP, the Company must make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, expenses and related disclosures at the date of the financial statements. Actual results could differ from those estimates. Additionally, operating results for the interim periods ended September 30, 2015 and 2014 are not necessarily indicative of the results that may be expected for any other interim period or for the full year. The condensed interim financial statements should be read in conjunction with the audited financial statements and notes thereto included in the Company’s Prospectus dated May 6, 2015 (“Prospectus”) filed pursuant to Rule 424 (b) (4) under the Securities Act of 1933, as amended, with the Securities and Exchange Commission (“SEC”) on May 7, 2015 in conjunction with the Company’s initial public offering of common stock. |
Initial Public Offering | Initial Public Offering In May 2015, the Company closed an initial public offering (“IPO”) of its common stock, which resulted in the sale of 6,670,000 shares of its common stock at a public offering price of $12.00 per share, including 870,000 shares of common stock upon the exercise by the underwriters of their option to purchase additional shares at the public offering price. The Company received proceeds from the IPO of approximately $72 ,029 , after deducting underwriting discounts, commissions and expenses payable by the Company. In connection with preparing for the IPO, the Company’s Board of Directors and shareholders approved a one -for-6.9 reverse stock split of the Company’s common stock. The reverse stock split became effective in April 2015. All share and per share amounts in the condensed interim financial statements and notes thereto have been retroactively adjusted for all periods presented to give effect to this reverse stock split, including reclassifying an amount equal to the reduction in par value of common stock to additional paid-in capital. In connection with the closing of the IPO, all of the Company’s outstanding convertible preferred stock automatically converted to common stock in May 2015, resulting in an additional 12,591,456 shares of common stock of the Company becoming outstanding. The significant increase in common stock outstanding in May 2015 is expected to impact the year-over-year comparability of the Company’s net loss per share calculations in future periods. |
Subsequent Events | Subsequent Events The Company considers events or transactions that occur after the balance sheet date but prior to the issuance of the financial statements to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure. Through the date of the filing of this Form 10-Q, the Company has concluded that no subsequent events have occurred that require disclosure, except as described in Note 9. |
Earnings (Loss) per Common Share | Earnings (Loss) per Common Share Earnings (loss) per common share is calculated using the two-class method, which is an earnings allocation formula that determines earnings (loss) per share for the holders of the Company’s common shares and participating securities. All series of preferred stock contain participation rights in any dividend paid by the Company and are deemed to be participating securities. Earnings available to common shareholders and participating convertible redeemable preferred shares is allocated first to the preferred stock based upon the distribution criteria in the Company’s Articles of Incorporation then the remainder to the common shareholders. The participating securities do not include a contractual obligation to share in losses of the Company and are not included in the calculation of net loss per share in the periods that have a net loss. Diluted earnings per share is computed using the more dilutive of (a) the two-class method, or (b) the if-converted method. The Company allocates earnings first to preferred shareholders based on dividend rights and then to common and preferred shareholders based on ownership interests. The weighted-average number of common shares included in the computation of diluted earnings (loss) gives effect to all potentially dilutive common equivalent shares, including outstanding stock options, warrants, convertible redeemable preferred stock and the potential issuance of stock upon the conversion of the Company’s convertible notes. Common stock equivalent shares are excluded from the computation of diluted earnings (loss) per share if their effect is antidilutive. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board (“FASB”), issued Accounting Standards Update (“ASU”), No. 2014-09, which amends the guidance for accounting for revenue from contracts with customers. This ASU supersedes the revenue recognition requirements in Accounting Standards Codification (“ASC”), Topic 605, Revenue Recognition, and creates a new Topic 606, Revenue from Contracts with Customers. Two adoption methods are permitted: retrospectively to all prior reporting periods presented, with certain practical expedients permitted; or retrospectively with the cumulative effect of initially adopting the ASU recognized at the date of initial application. On August 12, 2015, the FASB issued ASU No. 2015-14, which defers the effective date of ASU No. 2014-09 by one year to December 15, 2017 for annual reporting periods beginning after that date, including interim periods within those periods. The FASB also approved permitting early adoption of the standard, but not before the original effective date of December 15, 2016. The Company has not yet determined which adoption method it will utilize or the effect that the adoption of this guidance will have on its financial statements. In July 2015, the FASB issued ASU No. 2015-11, which amends existing guidance for measurement of inventory. Current inventory guidance requires an entity to measure inventory at the lower of cost or market. Market could be replacement cost, net realizable value, or net realizable value less an approximately normal profit margin. The amendments do not apply to inventory that is measured using last-in, first-out (LIFO) or the retail inventory method. The amendments apply to all other inventory, which includes inventory that is measured using first-in, first-out or average cost. An entity should measure all inventory to which the amendments apply at the lower of cost and net realizable value. Net realizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. Subsequent measurement is unchanged for inventory measured using LIFO or the retail inventory method. The amendments in the ASU No. 2015-11 more closely align the measurement of inventory pursuant to GAAP with the measurement of inventory pursuant to International Financial Reporting Standards. The amendments are effective for fiscal years beginning after December 15, 2016, and interim periods within fiscal years beginning after December 15, 2017. The amendments should be applied prospectively with earlier application permitted as of the beginning of an interim or annual reporting period. The Company does not expect the adoption of this guidance to have a material impact on its condensed financial statements. |
Net Loss per Common Share (Tabl
Net Loss per Common Share (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
NET LOSS PER COMMON SHARE | |
Schedule of computations of basic and diluted net loss per share | Three months ended Nine months ended September 30, September 30, 2015 2014 2015 2014 Net loss $ $ $ $ Extinguishment of preferred stock - see note 7 — — — Accretion of prior preferred stock - see note 7 — Accretion and dividends of Series D preferred stock — — — Loss attributable to common shareholders — basic and diluted $ $ $ $ Weighted-average number of common shares used in net loss per share—basic and diluted Net loss per share—basic and diluted $ $ $ $ |
Schedule of potentially dilutive securities excluded from computations of diluted weighted-average shares outstanding | Three months ended Nine months ended September 30, September 30, 2015 2014 2015 2014 Outstanding stock options Warrants Redeemable convertible preferred stock - - Unvested restricted stock |
Fair Value of Financial Instr18
Fair Value of Financial Instruments (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
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, 2015 Money market funds, included in cash equivalents $ $ $ — $ — December 31, 2014 Money market funds, included in cash equivalents $ $ $ — $ — |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
ACCRUED EXPENSES | |
Schedule of components of accrued expenses | September 30, 2015 December 31, 2014 Accrued compensation $ $ Accrued development costs Accrued marketing — Accrued audit and legal Accrued interest Accrued other Total accrued expenses $ $ |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
STOCK BASED COMPENSATION | |
Summary of restricted stock awards | Weighted average purchase price Shares per share Unvested at December 31, 2014 $ Granted Vested Unvested at September 30, 2015 (1) $ (1) Excludes 72,463 shares of unvested restricted stock remaining from the early exercise of stock options as of September 30, 2015. |
Summary of stock option activity | Weighted- Weighted- average average remaining Aggregate exercise price contractual Intrinsic Shares per share term (years) Value Outstanding at December 31, 2014 $ Granted Exercised Cancelled Outstanding at September 30, 2015 $ $ Exercisable at September 30, 2015 $ $ Vested and expected to vest at September 30, 2015 $ $ |
Schedule of weighted-average assumptions used in Black-Scholes option-pricing model | Nine months ended September 30, 2015 2014 Risk-free interest rate % % Dividend yield - - Volatility % % Expected term (years) |
Nature of Business (Details)
Nature of Business (Details) - USD ($) $ in Thousands | 1 Months Ended | ||
Mar. 31, 2015 | Sep. 30, 2015 | Dec. 31, 2014 | |
NATURE OF BUSINESS | |||
Maximum period automatic stay in effect | 30 months | ||
Deficit accumulated | |||
Deficit accumulated | $ 119,483 | $ 101,753 |
Summary of Significant Accoun22
Summary of Significant Accounting Policies (Details) $ / shares in Units, $ in Millions | 1 Months Ended |
May. 31, 2015USD ($)$ / sharesshares | |
Initial public offering | |
Sale of stock | |
Common stock sold (in shares) | 6,670,000 |
Offering price (in dollars per share) | $ / shares | $ 12 |
Proceeds from the offering, after deducting underwriting discounts and commissions | $ | $ 72 |
Underwriters over-allotment option | |
Sale of stock | |
Common stock sold (in shares) | 870,000 |
Summary of Significant Accoun23
Summary of Significant Accounting Policies (Details 2) | 1 Months Ended | |
May. 31, 2015shares | Apr. 30, 2015 | |
Conversion of stock | ||
Common stock split ratio | 0.144927536 | |
Conversion of redeemable convertible preferred stock into common stock | All series of convertible redeemable preferred stock | ||
Conversion of stock | ||
Number of shares of common stock into which convertible preferred stock was converted | 12,591,456 |
Net Loss Per Common Share (Deta
Net Loss Per Common Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||
Mar. 31, 2015 | Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Net loss per common share | |||||
Net loss | $ (9,362) | $ (6,556) | $ (17,730) | $ (14,448) | |
Extinguishment of preferred stock | 31,806 | ||||
Loss attributable to common stockholders - basic and diluted | $ (9,362) | $ (7,388) | $ (10,496) | $ (16,917) | |
Weighted-average number of common shares used in net loss per share-basic and diluted (in shares) | 20,531,406 | 940,627 | 11,179,756 | 926,597 | |
Net loss per share - basic and diluted (in dollars per share) | $ (0.46) | $ (7.85) | $ (0.94) | $ (18.26) | |
Series A, Series B and Series C convertible redeemable preferred stock | |||||
Net loss per common share | |||||
Extinguishment of preferred stock | $ 31,806 | ||||
Accretion and dividends of preferred stock | $ (832) | $ (23,327) | $ (2,469) | ||
Series D convertible redeemable preferred stock | |||||
Net loss per common share | |||||
Accretion and dividends of preferred stock | $ (1,245) |
Net Loss Per Common Share (De25
Net Loss Per Common Share (Details 2) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Stock options | ||||
Anti-dilutive securities | ||||
Potentially dilutive securities outstanding excluded from the computations of diluted weighted-average shares outstanding (in shares) | 1,356,246 | 311,365 | 1,356,246 | 311,365 |
Warrants | ||||
Anti-dilutive securities | ||||
Potentially dilutive securities outstanding excluded from the computations of diluted weighted-average shares outstanding (in shares) | 2,445 | 18,810 | 2,445 | 18,810 |
All series of convertible redeemable preferred stock | ||||
Anti-dilutive securities | ||||
Potentially dilutive securities outstanding excluded from the computations of diluted weighted-average shares outstanding (in shares) | 6,552,820 | 6,552,820 | ||
Restricted stock | ||||
Anti-dilutive securities | ||||
Potentially dilutive securities outstanding excluded from the computations of diluted weighted-average shares outstanding (in shares) | 153,589 | 28,536 | 153,589 | 28,536 |
Fair Value of Financial Instr26
Fair Value of Financial Instruments (Details) - Estimate of fair value - Recurring - Money market funds - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
Cash equivalents | $ 104,911 | $ 457 |
Quoted Prices in active markets (Level 1) | ||
Cash equivalents | $ 104,911 | $ 457 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
ACCRUED EXPENSES | ||
Accrued compensation | $ 1,169 | $ 635 |
Accrued development costs | 597 | 970 |
Accrued marketing | 685 | |
Accrued audit and legal | 109 | 249 |
Accrued interest | 31 | 71 |
Accrued other | 90 | 31 |
Total accrued expenses | $ 2,681 | $ 1,956 |
Convertible Bridge Note with 28
Convertible Bridge Note with Related Party (Details) - USD ($) $ in Thousands | 1 Months Ended | 2 Months Ended | 9 Months Ended |
Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2015 | |
Related party transactions | |||
Gain on extinguishment | $ 91 | ||
6.0% Convertible promissory notes | |||
Related party transactions | |||
Gain on extinguishment | $ 91 | ||
Bridge Notes Purchase Agreement | Investors | 6.0% Convertible promissory notes | |||
Related party transactions | |||
Amount issued | $ 5,000 | ||
Stated interest rate | 6.00% |
Convertible Preferred Stock (De
Convertible Preferred Stock (Details) - USD ($) | 1 Months Ended | 2 Months Ended | 3 Months Ended | 9 Months Ended | ||
May. 31, 2015 | Mar. 31, 2015 | Feb. 28, 2015 | Sep. 30, 2015 | Sep. 30, 2015 | Sep. 30, 2014 | |
Preferred stock | ||||||
Principal amount converted | $ 5,000,000 | |||||
Accruals of dividends and accretion to redemption value | 24,572,000 | $ 2,469,000 | ||||
Gain on extinguishment for amendment to dividend terms | 31,806,000 | |||||
6.0% Convertible promissory notes | ||||||
Preferred stock | ||||||
Principal amount converted | $ 5,000,000 | |||||
Series D convertible redeemable preferred stock | ||||||
Preferred stock | ||||||
Issuance of stock (in shares) | 41,666,667 | |||||
Aggregate consideration | $ 50,000,000 | |||||
Cash consideration from issuance of preferred stock | 45,000,000 | |||||
Accruals of dividends and accretion to redemption value | $ 0 | $ 24,572,000 | ||||
Series A convertible redeemable preferred stock | ||||||
Preferred stock | ||||||
Dividend rate (as a percent) | 4.50% | |||||
Series B convertible redeemable preferred stock | ||||||
Preferred stock | ||||||
Dividend rate (as a percent) | 8.00% | |||||
Series C convertible redeemable preferred stock | ||||||
Preferred stock | ||||||
Dividend rate (as a percent) | 8.00% | |||||
Series A, Series B and Series C convertible redeemable preferred stock | ||||||
Preferred stock | ||||||
Accrued dividends | $ 622,000 | |||||
Gain on extinguishment for amendment to dividend terms | 31,806,000 | |||||
Series A, Series B and Series C convertible redeemable preferred stock | Mandatory conversion, initial public offering | Minimum | ||||||
Preferred stock | ||||||
Gross proceeds from sale of stock | $ 50,000,000 | |||||
All series of convertible redeemable preferred stock | Conversion of redeemable convertible preferred stock into common stock | ||||||
Preferred stock | ||||||
Number of shares of common stock into which convertible preferred stock was converted | 12,591,456 |
Stock-based Compensation (Detai
Stock-based Compensation (Details) - shares | 1 Months Ended | 9 Months Ended | |
Apr. 30, 2015 | Sep. 30, 2015 | Jul. 31, 2014 | |
Stock options | |||
Stock-based compensation | |||
Vesting period | 4 years | ||
Contractual life | 10 years | ||
Stock options | Minimum | |||
Stock-based compensation | |||
Period following termination date vested options are exercisable | 1 month | ||
Stock options | Maximum | |||
Stock-based compensation | |||
Period following termination date vested options are exercisable | 3 months | ||
2014 Stock Incentive Plan | |||
Stock-based compensation | |||
Shares of common stock authorized for issuance (in shares) | 2,700,000 | 525,700 | |
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% |
Stock-based Compensation (Det31
Stock-based Compensation (Details 2) | 9 Months Ended |
Sep. 30, 2015$ / sharesshares | |
Restricted stock awards | |
Unvested at beginning of year (in shares) | 15,387 |
Granted (in shares) | 194,694 |
Vested (in shares) | (128,955) |
Unvested at end of year (in shares) | 81,126 |
Weighted-average purchase price per share | |
Unvested at beginning of year (in dollars per share) | $ / shares | $ 0.69 |
Granted (in dollars per share) | $ / shares | 5.73 |
Vested (in dollars per share) | $ / shares | 5.13 |
Unvested at end of year (in dollars per share) | $ / shares | $ 5.73 |
Restricted stock | |
Restricted stock awards | |
Unvested remaining from the early exercise of stock options (in shares) | 72,463 |
Stock-based Compensation (Det32
Stock-based Compensation (Details 3) $ / shares in Units, $ in Thousands | 9 Months Ended |
Sep. 30, 2015USD ($)$ / sharesshares | |
Stock option activity | |
Outstanding at beginning of year (in shares) | shares | 281,029 |
Granted (in shares) | shares | 1,197,452 |
Exercised (in shares) | shares | (121,729) |
Cancelled (in shares) | shares | (506) |
Outstanding at end of period (in shares) | shares | 1,356,246 |
Exercisable at end of period (in shares) | shares | 208,438 |
Vested and expected to vest at end of period (in shares) | shares | 1,341,543 |
Weighted average exercise price per share | |
Outstanding at beginning of year (in dollars per share) | $ 0.69 |
Granted (in dollars per share) | 10.47 |
Exercised (in dollars per share) | 3.89 |
Cancelled (in dollars per share) | 2.06 |
Outstanding at end of period (in dollars per share) | 9.04 |
Exercisable at end of period (in dollars per share) | 2.65 |
Vested and expected to vest at end of period (in dollars per share) | $ 9.13 |
Stock option activity, additional information | |
Outstanding at end of period, Weighted-average remaining contractual term | 9 years 2 months 12 days |
Exercisable at end of period, Weighted-average remaining contractual term | 7 years 10 months 24 days |
Vested and expected to vest at end of period, weighted-average remaining contractual term | 9 years 2 months 12 days |
Outstanding at end of period, Aggregate Intrinsic Value | $ | $ 17,722 |
Exercisable at end of period, Aggregate Intrinsic Value | $ | 4,056 |
Vested and expected to vest at end of period, Aggregate Intrinsic Value | $ | $ 18,595 |
Stock-based Compensation (Det33
Stock-based Compensation (Details 4) | 9 Months Ended | |
Sep. 30, 2015 | Sep. 30, 2014 | |
Weighted-average assumptions used in the Black-Scholes option pricing model to determine the fair value of the employee stock option grants | ||
Risk-free interest rate | 1.70% | 1.80% |
Volatility | 77.00% | 77.00% |
Expected term (in years) | 6 years 2 months 16 days | 6 years 3 months |
Commitments and Contingencies (
Commitments and Contingencies (Details) - patent | Mar. 26, 2015 | Mar. 24, 2015 | Sep. 30, 2015 |
Purdue Pharma, L. P. patent infringement suit, District of Delaware | |||
Contingencies | |||
Number of patents asserted to have been infringed | 4 | ||
Purdue Pharma, L. P., patent infringement suit, District of Massachusetts | |||
Contingencies | |||
Number of patents asserted to have been infringed | 4 | ||
Hatch-Waxman Act of 1984 election to sue for patent infringement | Maximum | |||
Contingencies | |||
Stay period before FDA can issue a final approval if patent litigation is elected | 30 months |
Commitments and Contingencies35
Commitments and Contingencies (Details 2) | 1 Months Ended |
Mar. 31, 2015ft² | |
Office and research facility operating lease | |
Lease | |
Square of feet of space | 19,335 |
Term of lease extension option | 5 years |
Amendment to office and research facility operating lease | |
Lease | |
Square of feet of space | 9,660 |
Delivery of expansion space with substantial completion of certain improvements | Office and research facility operating lease | |
Lease | |
Lease term | 5 years |