Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2015 | Oct. 30, 2015 | |
Document and Entity Information [Abstract] | ||
Entity Registrant Name | POZEN INC /NC | |
Entity Central Index Key | 1,059,790 | |
Current Fiscal Year End Date | --12-31 | |
Entity Well-known Seasoned Issuer | No | |
Entity Voluntary Filers | No | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 32,777,755 | |
Document Fiscal Year Focus | 2,015 | |
Document Fiscal Period Focus | Q3 | |
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2015 |
CONSOLIDATED BALANCE SHEETS (Un
CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($) | Sep. 30, 2015 | Dec. 31, 2014 |
Current assets: | ||
Cash and cash equivalents | $ 36,991,056 | $ 40,582,415 |
Investments in warrants | 0 | 2,678,773 |
Accounts receivable | 5,820,184 | 5,629,209 |
Prepaid expenses and other current assets | 396,860 | 583,061 |
Total current assets | 43,208,100 | 49,473,458 |
Property and equipment, net of accumulated depreciation | 22,115 | 27,382 |
Noncurrent deferred tax asset | 0 | 952,900 |
Total assets | 43,230,215 | 50,453,740 |
Current liabilities: | ||
Accounts payable | 1,127,705 | 606,948 |
Accrued compensation | 6,727,299 | 1,899,456 |
Accrued expenses | 5,197,830 | 253,624 |
Current deferred tax liability | 0 | 952,900 |
Total current liabilities | 13,052,834 | 3,712,928 |
Long-term liabilities: | ||
Accrued compensation | 1,131,017 | 0 |
Total liabilities | 14,183,851 | 3,712,928 |
Preferred stock, $0.001 par value; 10,000,000 shares authorized, issuable in series, of which 90,000 shares are designated Series A Junior Participating Preferred Stock, none outstanding | 0 | 0 |
Common stock, $0.001 par value, 90,000,000 shares authorized; 32,765,541 and 32,221,397 shares issued and outstanding at September 30, 2015 and December 31, 2014, respectively | 32,766 | 32,221 |
Additional paid-in capital | 150,374,747 | 143,613,024 |
Accumulated deficit | (121,361,149) | (96,904,433) |
Total stockholders' equity | 29,046,364 | 46,740,812 |
Total liabilities and stockholders' equity | $ 43,230,215 | $ 50,453,740 |
CONSOLIDATED BALANCE SHEETS (U3
CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) - $ / shares | Sep. 30, 2015 | Dec. 31, 2014 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 90,000,000 | 90,000,000 |
Common stock, shares issued (in shares) | 32,765,541 | 32,221,397 |
Common stock, shares outstanding (in shares) | 32,765,541 | 32,221,397 |
Series A Junior Participating Preferred Stock [Member] | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 90,000 | 90,000 |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Revenue: | ||||
Licensing revenue | $ 5,820,184 | $ 7,539,741 | $ 15,425,499 | $ 22,507,723 |
Operating expenses: | ||||
Selling, general and administrative | 12,206,807 | 2,573,958 | 33,662,567 | 7,897,698 |
Research and development | 1,806,649 | 1,054,218 | 5,092,080 | 4,808,488 |
Total operating expenses | 14,013,456 | 3,628,176 | 38,754,647 | 12,706,186 |
Interest and other income (loss) | 17,140 | 2,840,604 | (153,568) | 2,854,781 |
(Loss) income before income tax expense | (8,176,132) | 6,752,169 | (23,482,716) | 12,656,318 |
Income tax benefit (expense) | (27,000) | 0 | 974,000 | 0 |
Net (loss) income attributable to common stockholders | $ (8,149,132) | $ 6,752,169 | $ (24,456,716) | $ 12,656,318 |
Basic net (loss) income per common share (in dollars per share) | $ (0.25) | $ 0.21 | $ (0.75) | $ 0.41 |
Shares used in computing basic net (loss) income per common share (in shares) | 32,732,686 | 31,589,192 | 32,476,358 | 31,118,572 |
Diluted net (loss) income per common share (in dollars per share) | $ (0.25) | $ 0.20 | $ (0.75) | $ 0.39 |
Shares used in computing diluted net (loss) income per common share (in shares) | 32,732,686 | 32,949,779 | 32,476,358 | 32,614,051 |
Comprehensive (loss) income | $ (8,149,132) | $ 6,752,169 | $ (24,456,716) | $ 12,656,318 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) | 9 Months Ended | |
Sep. 30, 2015 | Sep. 30, 2014 | |
Operating activities | ||
Net (loss) income | $ (24,456,716) | $ 12,656,318 |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 12,705 | 13,975 |
Loss on sale of warrants | 199,373 | 0 |
Gain on investment in warrants | 0 | (2,449,021) |
Noncash compensation expense | 5,673,287 | 1,914,614 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (190,975) | (3,866,741) |
Prepaid expenses and other current assets | 186,201 | (301,438) |
Accounts payable and other accrued expenses | 11,423,823 | (3,281,199) |
Deferred Revenue | 0 | (7,000,000) |
Net cash used in operating activities | (7,152,302) | (2,313,492) |
Investing activities | ||
Purchase of equipment | (7,438) | (4,426) |
Proceeds from sale of warrants | 2,479,400 | 0 |
Net cash provided by (used in) investing activities | 2,471,962 | (4,426) |
Financing activities | ||
Proceeds from issuance of common stock | 1,684,341 | 5,622,871 |
Payments related to net settlement of stock-based awards | (595,360) | (192,488) |
Net cash provided by financing activities | 1,088,981 | 5,430,383 |
Net (decrease) increase in cash and cash equivalents | (3,591,359) | 3,112,465 |
Cash and cash equivalents at beginning of period | 40,582,415 | 32,827,732 |
Cash and cash equivalents at end of period | $ 36,991,056 | $ 35,940,197 |
Significant Accounting Policies
Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2015 | |
Significant Accounting Policies [Abstract] | |
Significant Accounting Policies | 1. Significant Accounting Policies General POZEN Inc. (“we” or “POZEN” or the “Company”) was incorporated in the State of Delaware on September 25, 1996 and is operating in a single reportable segment. The Company has been a pharmaceutical company committed to transforming medicine that transforms lives. Since inception, the Company has focused its efforts on developing products which can provide improved efficacy, safety or patient convenience in the treatment of acute and chronic pain and pain related conditions and has developed a portfolio of integrated aspirin therapies. Historically, the Company has entered into collaboration agreements to commercialize its product candidates. The Company’s licensing revenues include upfront payments, additional payments if and when certain milestones in the product’s development or commercialization are reached, and the eventual royalty payments based on product sales. We decided to retain ownership of our proprietary, investigational, coordinated-delivery tablets combining immediate-release omeprazole, a proton pump inhibitor, or PPI, and enteric-coated, or EC, aspirin in a single tablet, now known as YOSPRALA ® Retirement of John R. Plachetka; Appointment of Adrian Adams as Chief Executive Officer and Andrew I. Koven as President and Chief Business Officer On June 1, 2015, that John R. Plachetka, Pharm.D., our Chairman of the Board of Directors, Chief Executive Officer and President retired effective immediately. Dr. Plachetka also resigned from the Company’ Proposed Business Combination with Tribute Pharmaceuticals Canada Inc. On June 8, 2015, we and Tribute Pharmaceuticals Canada Inc. (“Tribute”) agreed to a business combination under the terms of the Agreement and Plan of Merger and Arrangement, among Tribute, Aguono Limited (which was renamed Aralez Pharmaceuticals Limited and which, prior to the merger effective time, as defined in the Merger Agreement, will re-register as a public limited company incorporated in Ireland and be renamed as Aralez Pharmaceuticals plc) (“Parent”), Trafwell Limited (which was renamed Aralez Pharmaceutical Holdings Limited) (“Ltd2”), ARLZ US Acquisition Corp., ARLZ CA Acquisition Corp. (“Can Merger Sub”) and POZEN, dated as of June 8, 2015, as amended (the “Merger Agreement”). On August 19, 2015, the parties amended the Merger Agreement pursuant to that certain Amendment No. 1 to the Merger Agreement, whereby ARLZ US Acquisition II Corp. (“US Merger Sub”) replaced ARLZ US Acquisition Corp. in order to optimize the corporate structure of the Parent in the future. In order to effect the transactions contemplated by the Merger Agreement, US Merger Sub, an indirect subsidiary of Parent, will be merged with and into the Company (the “Merger”). We will be the surviving corporation and, through the Merger, will become an indirect wholly-owned subsidiary of Parent. The merger of the Company into US Merger Sub will be effected under Delaware law so that we will be reorganized into a holding company structure. In accordance with the Merger Agreement, Can Merger Sub will offer to acquire, and will acquire, all of the outstanding Tribute common shares, no par value per share (the “Tribute Common Shares”) pursuant to a court approved plan of arrangement in Canada in the manner provided for by the Merger Agreement (the “Arrangement”). The Parent Shares (as defined below) to be issued to Tribute shareholders in the Arrangement are not being registered pursuant to this registration statement. Upon completion of the Arrangement, Tribute will also become an indirect wholly-owned subsidiary of Parent. Upon completion, the Merger and the Arrangement do not constitute a change of control of the Company. As a result of the Merger, each share of the Company’s common stock will be converted into the right to receive from Parent one ordinary share of Parent, $0.001 nominal value per share each. A “Parent Share” and collectively, the “Parent Shares” (the “Merger Consideration”) for each share of the Company common stock that they own as of the record date (as defined below). Pursuant to the Arrangement, each outstanding Tribute Common Share will be exchanged for 0.1455 Parent Shares. Upon completion of the Merger and Arrangement, current stockholders of the Company will own approximately 66% of the outstanding Parent Shares, and current Tribute shareholders will own approximately 34% of the outstanding Parent Shares before giving effect to (i) any exercise of outstanding options and warrants or the vesting and delivery of shares underlying restricted stock units (“RSUs”) of either company and (ii) the Parent Shares to be issued to new investors pursuant to the equity and debt financings described below. It is expected that Parent Shares will be listed and traded on the NASDAQ Stock Market LLC (“NASDAQ”) under the symbol “ARLZ” and application has been made to list the Parent Shares on the Toronto Stock Exchange (the ‘TSX”) under the symbol “ARZ”. In connection with the proposed Merger and Arrangement, Parent filed with the U.S. Securities and Exchange Commission (“SEC”) a registration statement on Form S-4 on July 20, 2015, as amended by Amendment No. 1 to the Form S-4 filed on August 19, 2015, that includes the joint proxy statement/prospectus of Parent and the Company that also constitutes a prospectus of Parent. Such registration statement has not yet been declared effective by the SEC. We plan to mail the joint proxy statement/prospectus to our stockholders in connection with the transaction. Note: Update if S-4 becomes effective and proxy mailed to shareholders before 10-Q filed The completion of the Merger and Arrangement is subject to the approval of our stockholders and the shareholders of Tribute. In addition, the Merger and the Arrangement are subject to other customary closing conditions, including, among others, (i) the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, if applicable, (ii) the declaration by the SEC of the effectiveness of the joint proxy Statement/prospectus of the Parent and the Company on Form S-4. Note: Update if S-4 becomes effective and proxy mailed to shareholders before 10-Q filed, (iii) the approval of the listing on the NASDAQ Stock Market LLC and the Toronto Stock Exchange of the Parent Shares to be issued in connection with the Merger and Arrangement, and (iv) the conditions to closing the equity and debt financings described below having been met or waived. NOTE: DLA to amend to reflect the amendments to the Facility Agreement On June On June 8, 2015, we also executed a Share Subscription Agreement (the “Subscription Agreement”) by and among the QLT Inc., a specialty pharmaceutical corporation existing under the laws of the Province of British Columbia, Canada (“Purchaser”), Tribute, Parent, us and the following investors: Deerfield Private Design; Deerfield International; Deerfield Partners; EoR1 Capital Fund, L.P.; EcoR1 Capital Fund Qualified, L.P.; Broadfin Healthcare Master Fund, Ltd; JW Partners, LP, and JW Opportunities Fund, LLC (each, an “Investor” and together, the “Investors”). Pursuant to the Subscription Agreement, Parent will sell to Purchaser and the Investors up to $75 million of the Parent Shares in a private placement at a purchase price of $7.20 per Parent Share. The Subscription Agreement provides that the Company will prepare and file two registration statements with the SEC or such form as may be required to effect a registration of the Parent Shares issued under the Subscription Agreement within 60 days of the date of the signing of the Subscription Agreement and for certain other registration rights for each of Purchaser and the Investors under the Securities Act and the rules and regulations thereunder, or any similar successor statute, and applicable state securities laws. This agreement does not close until the closing of the Merger. A description of the Merger Agreement, the Facility Agreement and the Subscription Agreement, as well as other agreements related to the Merger and financing transactions is set forth in a Form 8-K we filed with the SEC on June 8, 2015 and copies of these agreements are attached as exhibits to such Form 8-K. The foregoing description of these agreements does not purport to be complete and is qualified in its entirety by reference to the full text of the agreements. Basis of Presentation The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, POZEN Limited, Aralez R&D and Aralez Pharmaceuticals US Inc. POZEN Limited was formed in May 2015 as an intellectual property development and product sales company. Aralez R&D Inc. was formed in September 2015 to perform research and development services as directed by Pozen Limited, including, but not limited to, research activities with respect to intellectual property owned or licensed by Pozen Limited. Aralez Pharmaceuticals US Inc. was formed in July 2015 as a non-exclusive distributor of product developed and manufactured by Pozen Limited. All intercompany transactions and balances have been eliminated. The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial reporting and the instructions to Form 10-Q and do not include all of the information and footnotes required for complete financial statements. In the opinion of the Company’s management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of the results for the interim periods have been included. Operating results for the three and nine months ended September 30, 2015 are not necessarily indicative of the results for the year ending December 31, 2015 or future periods. The accompanying financial statements should be read in conjunction with the Company’s audited financial statements and related notes included in the Company’s Annual Report on Form 10-K filed on March 11, 2015 and available on the website of the SEC (www.sec.gov). The accompanying balance sheet as of December 31, 2014 has been derived from the audited balance sheet as of that date included in the Form 10-K. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2015 | |
Summary of Significant Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Use of Estimates— Accrued expenses, including contracted costs— The Company believes that its current assumptions and other considerations used to estimate accrued expenses for the period are appropriate. However, determining the date on which certain contract services commence, the extent of services performed on or before a given date and the cost of such, paid and unpaid, involves subjective judgments and estimates and often must be based upon information provided by third parties. In the event that management does not identify certain contract costs which have begun to be incurred or under- or over-estimates the extent of services performed or the costs of such services, management adjusts costs during the period in which the information becomes available. Accrued costs related to product development and operating activities, based upon the progress of these activities covered by the related contracts, invoices received and estimated costs totaled $5.2 million at September 30, 2015 and $0.3 million at December 31, 2014. The variance, at each of these ending periods, between the actual expenses incurred and the estimated expenses accrued was not material or significant. Accrued Employee Compensation— In June 2015, we announced the adoption of an employee severance plan to provide severance benefits to eligible employees terminated involuntarily under certain circumstances. Under the plan these employees will be paid on-going payments of approximately $4.2 million. Employees are required to render service beyond a minimum period; therefore, such benefits are being accrued over the respective service period. The first payment was made in November 2015 and payments will continue through September 2017. Through the quarter ended September 30, 2015, $470,000 was recorded as R&D expense and $1.2 million was recorded as selling, general and administrative expense. Since no cash payment were incurred through the quarter ended September 30, 2015, the 2015 expense was recorded as accrued compensation. Revenue Recognition— With regard to royalty revenues, the Company’s licensing agreements have terms that include royalty payments based on the manufacture, sale or use of the Company’s products or technology. VIMOVO ® Also, with regard to the licensing revenues, the Company’s licensing agreements have had terms that include upfront payments upon contract signing and additional payments if and when certain milestones in the product’s development or commercialization are reached. Historically, the non-refundable portion of upfront payments received under the Company’s existing agreements is deferred by the Company upon receipt and recognized on a straight-line basis over periods ending on the anticipated date of regulatory approvals, as specified in the agreements relating to the product candidates, or the conclusion of any obligation on the part of the Company. If regulatory approvals or other events relating to our product candidates are accelerated, delayed or not ultimately obtained, then the amortization of revenues for these products is prospectively accelerated or reduced accordingly. Milestone payments along with the refundable portions of up-front payments are recognized as licensing revenue upon the achievement of specified milestones if (i) the milestone is substantive in nature and the achievement of the milestone was not reasonably assured at the inception of the agreement; and (ii) the fees are non-refundable. Any milestone payments received prior to satisfying these revenue recognition criteria are recorded as deferred revenue. In September 2013, the Company announced the signing of an exclusive license agreement for its PA products with Sanofi U.S., including, PA8140 and PA32540, in the United States to commercialize all PA combinations that contain 325 mg or less of enteric-coated aspirin in the United States. On November 29, 2014, we executed a termination agreement with Sanofi U.S. terminating the license. As of the termination date, all licenses granted to Sanofi U.S. were terminated and all rights to the products licensed to Sanofi U.S. under the agreement reverted to us. The Company received an upfront payment of $15.0 million which was included within the license revenue and was completely amortized by the end of the 2014 fiscal year. The licensing revenue for the three and nine months ended September 30, 2014 was $2.0 million and $7.0 million, respectively. On March 21, 2011, the Company entered into a license agreement with Cilag GmbH International (“Cilag”) a division of Johnson & Johnson, for the exclusive development and commercialization of MT 400 in Brazil, Colombia, Ecuador and Peru. Cilag’s upfront payment of $257,300 was deferred until the licensing agreement’s termination on December 22, 2014 and was included in other licensing revenue for the fiscal year ended December 31, 2014. Income Taxes— The accounting estimates used to compute the interim provision for income taxes may change as new events occur, additional information is obtained, or the tax environment changes. Since our inception, we have incurred substantial cumulative losses and may incur recurring losses in future periods. The utilization of these loss carryforwards to reduce future income taxes will depend on the Company’s ability to generate sufficient taxable income prior to the expiration of the loss carryforwards. In addition, the maximum annual use of net operating loss and research credit carryforwards is limited in certain situations where changes occur in stock ownership. We currently file income tax returns in the U.S. federal jurisdiction, and the state of North Carolina. We are no longer subject to federal or North Carolina income tax examinations by tax authorities for years before 2012. However, the loss carryforwards generated prior to 2012 may still be subject to change, if we subsequently begin utilizing these losses in a year that is open under statute and subject to federal or North Carolina income tax examinations by tax authorities. On May 21, 2015, the Company formed Pozen Limited, which was organized under the laws of Ireland, for the purpose of acquiring the rights to commercialize Yosprala, Treximet and MT 400. On May 27, 2015, the Company and Pozen Limited entered into an intercompany license agreement whereby the Company granted Pozen Limited a non-exclusive right to exercise certain product technologies and related intangible rights with respect to Yosprala, Treximet and MT 400. In consideration of the grant of the non-exclusive license, Pozen Limited made a fixed royalty payment and will pay additional contingent royalty payments to the Company. As a result of the intercompany license arrangement, the Company may utilize certain of its existing deferred tax assets to reduce current year income resulting from the transaction. As of September 30, 2015, no cash payment has been made relative to the intercompany license agreement. At the time cash payment is made, the Company may be subject to withholding taxes. No provision has been made for these future potential withholding tax obligations. At September 30, 2015, we had no unrecognized tax benefits that would reduce the Company’s effective tax rate if recognized. We recognize any interest and penalties accrued related to unrecognized tax benefits as income tax expense. During the nine months ended September 30, 2015 and 2014, there were no such interest and penalties. The Company currently anticipates being able to utilize existing US tax attributes to offset expected US taxable income in 2015, including US taxable income resulting from the intercompany license agreement with POZEN Limited. The Company believes that should the proposed business combination with Tribute Pharmaceuticals Canada Inc. be completed as anticipated within the next twelve months, it is reasonably possible that an unrecognized tax benefit of $17M to $19M related to utilization of these US tax attributes may be established. Additionally, the Company may determine it necessary to make future cash payments of these amounts. The establishment of this unrecognized tax position would impact our effective tax rate. Cash, Cash Equivalents, Investments and Concentration of Credit Risk — The Company invests in high-credit quality investments in accordance with its investment policy, which attempts to minimize the possibility of loss. However, cash and cash equivalents include financial instruments that potentially subject the Company to a concentration of credit risk. Cash and cash equivalents are of a highly liquid nature and are held with high credit quality financial institutions and money market mutual fund managers. Cash held directly with financial institutions is insured up to $250,000 per account and any excess amounts are uninsured. Cash is also held in insured bank deposits through a cash management program that offers a bank network ensuring full FDIC insurance on all deposits. The Company’s cash and cash equivalents are held in fully insured bank deposits and approximately 5% by money market mutual fund managers. In connection with its acquisition of all rights, title and interest to develop, commercialize and sell Treximet ® The following table sets forth our financial instruments carried at fair value as of September 30, 2015 and December 31, 2014: Financial Instruments Carried at Fair Value September 30, 2015 December 31, 2014 Assets: Cash and cash equivalents $ 36,991,056 $ 40,582,415 Investments in Pernix warrants ― 2,678,773 Total cash and investments $ 36,991,056 $ 43,261,188 Fair Value of Financial Instruments Financial instruments consist of cash and cash equivalents, short-term investments, accounts receivable and accounts payable. The carrying values of these amounts approximate the fair value due to their short-term nature. Fair Value Measurement The Company defines fair value (“FV”) as the price that would be received to sell an asset or paid to transfer a liability ("the exit price") in an orderly transaction between market participants at the measurement date. The FV hierarchy for inputs maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available. The Company uses the following hierarchy of inputs to measure FV: ☐ Level 1 - quoted prices in active markets for identical assets and liabilities. ☐ Level 2 - observable inputs other than quoted prices in active markets for identical assets and liabilities, including quoted prices in active markets for instruments that are similar or quoted prices in markets that are not active for identical or similar instruments and model-derived valuations in which all significant inputs and value drivers are observable in active markets. ☐ Level 3 - unobservable inputs that are significant to the overall valuation, for which there is little or no market data available and which require the Company to develop its own assumptions. The Company values investments using the most observable inputs available that are current as of the measurement date and classifies them according to the lowest level of inputs used. Observable inputs are inputs that market participants would use in pricing the asset or liability developed from market data obtained from independent sources. Unobservable inputs are inputs that reflect the Company’s judgment concerning the assumptions that market participants would use in pricing the asset or liability developed from the best information available under the circumstances. The financial assets for which we perform recurring measurements are cash equivalents and investments in warrants. As of September 30, 2015, financial assets utilizing Level 1 inputs included cash equivalents. Financial assets utilizing Level 2 inputs included investments in warrants. Fair value is a market-based measure considered from the perspective of a market participant who holds the asset or owes the liability rather than an entity-specific measure. Therefore, even when market assumptions are not readily available, our own assumptions are set to reflect those that market participants would use in pricing the asset or liability at the measurement date. Our Level 1 valuations are based on the market approach and consist primarily of quoted prices for identical items on active securities exchanges. Our Level 2 valuations may also use the market approach and are based on significant other observable inputs such as quoted prices for financial instruments not traded on a daily basis. We did not rely on Level 3 input for valuation of our securities at September 30, 2015. Stock Plans In 1996, the Company established a Stock Option Plan (the “Option Plan”) and authorized the issuance of options to attract and retain quality employees and to allow such employees to participate in the growth of the Company. In June 2000, the stockholders approved the POZEN Inc. 2000 Equity Compensation Plan (the “2000 Plan”) and the 2000 Plan became effective upon the completion of the Company’s initial public offering in October 2000, after which time no further grants were made under the Option Plan. In May 2004, the stockholders approved an amendment to and restatement of the 2000 Plan. The amendment to the 2000 Plan provided for an increase in the number of shares of common stock authorized for issuance under the 2000 Plan from 3,000,000 to 5,500,000 shares. In June 2007, the stockholders approved the amendment and restatement of the 2000 Plan to, among other things, increase the number of shares authorized for issuance under the 2000 Plan to 6,500,000 shares and continue the various performance criteria for use in establishing specific vesting targets for certain awards. In June 2010, stockholders approved the POZEN Inc. 2010 Equity Compensation Plan, (“the 2010 Plan”), a successor incentive compensation plan to the 2000 Plan which was merged with and into the 2010 Plan and all grants outstanding under the 2000 Plan were issued or transferred under the 2010 Plan. The 2010 Plan provides for grants of incentive stock options, nonqualified stock options, stock awards, and other stock-based awards, such as restricted stock units and stock appreciation rights (“SARs”), to employees, non-employee directors, and consultants and advisors who perform services for us and our subsidiaries. The 2010 Plan authorizes up to 7,452,327 shares of common stock for issuance, which includes 2,000,000 shares of our common stock which were in excess of the number of shares previously reserved under the 2000 Plan. The maximum number of shares for which any individual may receive grants in any calendar year is 1,000,000 shares. The Compensation Committee of the Board of Directors, which administers the 2010 Plan, will determine the terms and conditions of options, including when they become exercisable. Neither our Board nor the Committee can amend the 2010 Plan or options previously granted under the Plan to permit a repricing of options or SARs, without prior stockholder approval. If options granted under the 2010 Plan expire or are terminated for any reason without being exercised, or if stock awards, performance units, or other stock-based awards are forfeited or otherwise terminate, the shares of common stock underlying the grants will again be available for awards granted under the 2010 Plan. As a result of a December 31, 2013 cash dividend distribution, a dividend equivalent totaling 987,000 shares was provided to all outstanding grants. The adjustments were in the form of additional RSUs to RSU holders or an adjustment to both the outstanding number of options and their strike price, in compliance with Sections 409A and 424 of the Internal Revenue Code. If the Merger becomes effective, we intend to terminate the 2010 Omnibus Equity Incentive Plan and no further grants will be made thereunder, and shares with respect to all grants outstanding under the 2010 Plan will be issued under or transferred to the Aralez Pharmaceuticals plc 2015 Long-Term Incentive Plan. Time-Based Stock Awards For the nine months ended September 30, 2015 and 2014, the Company recognized $517,000 and $720,000, respectively, in compensation expense related to time-base stock awards. No new time-based awards were granted during the nine months ended September 30, 2015 and September 30, 2014. Previously, the fair value of each time-based award was estimated on the date of grant using the Black-Scholes option valuation model. Historically, the expected volatility rate was estimated based on an equal weighting of the historical volatility of POZEN common stock over approximately a six-year period, the expected term was based upon average historical terms to exercise and the risk-free interest rate was based on six-year U.S. Treasury securities. The pre-vesting forfeiture rates used were also based on historical rates. We adjust the estimated forfeiture rate based upon actual experience. A summary of the time-based stock awards as of September 30, 2015, and changes during the nine months ended September 30, 2015, are as follows: Time-Based Stock Awards Underlying Shares (000s) Weighted-Average Exercise Price Average Remaining Contractual Term (years) Aggregate Intrinsic Value (000s) Outstanding at December 31, 2014 2,341 $ 7.39 4.1 $ 4,382 Granted ― ― Exercised (65 ) 4.09 Forfeited or expired ― ― Outstanding at March 31, 2015 2,277 7.48 3.8 $ 3,796 Exercisable at March 31, 2015 2,095 $ 7.79 3.5 $ 3,098 Vested or expected to vest at March 31, 2015 2,249 $ 7.48 3.8 $ 3,751 Granted ― ― Exercised (582 ) 5.84 Forfeited or expired (33 ) 13.77 Outstanding at June 30, 2015 1,662 7.90 3.5 $ 5,467 Exercisable at June 30, 2015 1,480 $ 8.39 3.1 $ 4,300 Vested or expected to vest at June 30, 2015 1,634 $ 7.90 3.5 $ 5,377 Granted ― ― Exercised (68 ) 4.95 Forfeited or expired (3 ) 3.87 Outstanding at September 30, 2015 1,591 8.03 3.2 $ 1,053 Exercisable at September 30, 2015 1,528 $ 8.20 3.0 $ 929 Vested or expected to vest at September 30, 2015 1,581 $ 8.03 3.2 $ 1,047 The aggregate intrinsic value of options outstanding represents the pretax value (the period’s closing market price, less the exercise price, times the number of in-the-money options) that would have been received by all option holders had they exercised their options at the end of the period. A total of 715,000 stock options were exercised during the nine months ended September 30, 2015 with an intrinsic value of $2.1 million, and a total of 994,000 stock options were exercised during the nine months ended September 30, 2014 with an intrinsic value of $2.7 million. A summary of the time-based nonvested awards as of September 30, 2015, and changes during the nine months ended September 30, 2015, are as follows: Underlying Shares (000s) Weighted-Average Exercise Price Nonvested outstanding at December 31, 2014 477 $ 3.85 Granted ― ― Forfeited or expired ― ― Vested (296 ) 4.47 Nonvested outstanding at March 31, 2015 181 $ 3.87 Granted ― ― Forfeited or expired ― ― Vested ― ― Nonvested outstanding at June 30, 2015 181 $ 3.87 Granted ― ― Forfeited or expired (3 ) 3.87 Vested (115 ) 3.87 Nonvested outstanding at September 30, 2015 63 $ 3.87 Restricted Stock and Restricted Stock Units For the nine months ended September 30, 2015 and 2014, the Company recognized $4.4 million and $770,000, respectively, in compensation expense related to restricted stock units. A summary of the restricted stock unit awards as of September 30, 2015, and changes during the nine months ended September 30, 2015, are as follows: Underlying Shares (000s) Weighted-Average Exercise Price Restricted stock outstanding at December 31, 2014 1,109 $ 7.14 Granted ― ― Vested and released (49 ) 7.17 Forfeited or expired ― ― Restricted stock outstanding at March 31, 2015 1,060 $ 7.14 Granted 3,543 7.76 Vested and released (37 ) 7.35 Forfeited or expired ― ― Restricted stock outstanding at June 30, 2015 4,566 $ 7.62 Granted 113 11.18 Vested and released ― ― Forfeited or expired (5 ) 7.22 Restricted stock outstanding at September 30, 2015 4,674 $ 7.70 As of September 30, 2015 there was an aggregate $27.9 million of unrecognized compensation expense related to unvested restricted stock units. Of the aggregate amount, $24.0 million unrecognized compensation expense related to unvested restricted stock units under the June 2015 award of 3,421,562 restricted stock units with a grant-date per-share fair value of $7.64. There were 3.9 million unvested restricted stock units outstanding at September 30, 2015 and 401,000 unvested restricted stock units outstanding at September 30, 2014. The total fair value of restricted stock that vested during the nine months ended September 30, 2015 and 2014 was $636,000 and $726,000, respectively. Performance-Based Awards In May 2008, pursuant to an incentive program (the “PN incentive program”) approved by the Compensation Committee of the Board of Directors of the Company, stock options were granted to all of the Company’s employees, including its executive officers, to purchase an aggregate of 281,433 shares of common stock with an exercise price of $14.45 per share. In September 2008, additional stock options were granted under the PN incentive program, to purchase 11,700 shares of common stock at an exercise price of $10.82 per share. The stock options have a ten-year term and have an exercise price equal to the closing sale price of the Company’s common stock, as reported on the NASDAQ Global Market, on the date of grant. Twenty-five percent (25%) of the PN incentive program options granted vested in 2009, upon completion of the performance goal and the remaining seventy-five percent (75%) of the options granted vested in 2010 upon the completion of the remaining performance goals. The fair value of the performance-based options granted under the PN incentive program was estimated as of the grant date using the Black-Scholes option valuation model without consideration of the performance measures. The options also include provisions that require satisfactory employee performance prior to vesting. Additionally, 20,000 options were granted to an executive officer in May 2008 under the PN incentive plan, with similar grant and exercise terms. The Company recognized compensation costs for these awards over the expected service period. In October 2011, pursuant to an incentive program (the “PA32540 incentive program”) approved by the Compensation Committee of the Board of Directors of the Company, stock options and RSUs were granted to all of the Company’s employees, including its executive officers, to purchase an aggregate of 453,960 shares of common stock. The underlying stock options and RSUs were performance-based and focus on the successful completion of certain value-enhancing events for the Company’s YOSPRALA product candidate. The stock options have a ten-year term and have an exercise price equal to the closing sale price of the Company’s common stock, as reported on the NASDAQ Global Market, on the date of grant. The underlying stock options and RSUs vested or will vest in accordance with the following schedule: (a) one-third (1/3) upon the acceptance of the filing of a new drug application (the “NDA”) for YOSPRALA, assuming the NDA filing is made prior to December 31, 2012, (b) one-third (1/3) upon first cycle NDA approval of YOSPRALA (otherwise 16.5% upon NDA approval after first cycle), and (c) one-third (1/3) upon execution of a significant partnering transaction for YOSPRALA in a major territory as determined by the Compensation Committee of the Company, in its sole discretion, at the time of such transaction, subject in each case to continued employment or service to the Company. During a pre-submission meeting with respect to its NDA for YOSPRALA in April 2012, the U.S. Food and Drug Administration, or FDA suggested that the Company also seek approval for a lower dose formulation of the product containing 81 mg of enteric coated aspirin as part of its NDA for YOSPRALA. The Company decided to include data and information relating to a lower dose formulation in its NDA. Generation of additional data with respect to lower dose formulation of YOSPRALA and incorporation of data into the NDA for YOSPRALA would delay submission of the NDA from the original planned submission date. Therefore, in October 2012, the Compensation Committee granted performance-based incentive awards (the “PA8140 incentive program”) both to compensate the employees for the expected loss of value under the PA32540 Incentive Program, as well as to provide additional incentive to employees to complete the value-added activities required for submission and approval of the lower dose product. The Compensation Committee granted an aggregate of 208,740 restricted stock units to various employees of the Company, including 105,000 restricted stock units granted to the Company’s named executive officers. The restricted stock units were performance-based and vested in accordance with the following schedule: (a) one-half (1/2) upon the acceptance by the FDA of the filing of an NDA for a lower dose YOSPRALA product candidate, and (b) one-half (1/2) upon approval by the FDA of an NDA for a lower dose YOSPRALA product candidate. In 2012, 132,883 options were forfeited in acknowledgement that certain performance goals would not be met under the PA32540 incentive program. In April 2014, the Compensation Committee granted an aggregate of 73,000 restricted stock units to various employees of the Company, including 65,000 restricted stock units granted to the Company’s named executive officers. The restricted stock units were performance-based and vested in accordance with the following schedule: (i) 50% upon receipt of the milestone payment by Sanofi U.S. under the License and Collaboration Agreement, dated as of September 3, 2013 (the "Agreement") to be received upon approval by the U.S. Food and Drug Administration of the PA product candidates; and (ii) 50% upon receipt of the milestone payment by Sanofi U.S. upon achievement of commercial readiness (as defined in the Agreement). The entire award was forfeited in 2014 upon the termination of the Sanofi U.S. agreement. In 2014, a total of 177,818 options were forfeited in acknowledgement that certain performance goals would not be met under the PA32540 and PA8140 incentive programs. As of September 30, 2015, there was $2,000 in unrecognized compensation expense related to performance-based awards granted under the PA32540 and PA8140 incentive programs. During the nine months ended September 30, 2015, the Company recognized $784,000 in compensation expense related to performance-based awards, of which $779,000 was recognized related to the performance-based stock awards vesting acceleration, as defined under the separation agreement with the Company’s former President and Chief Executive Officer. During the nine months ended September 30, 2014, there was expense of $425,000 recorded for performance-based awards. A summary of the performance-based stock awards as of September 30, 2015, and changes during the nine months ended September 30, 2015, are as follows: Underlying Shares (000s) Weighted-Average Exercise Price Performance-based outstanding at December 31, 2014 368 $ 8.12 Granted ― ― Exercised (10 ) 1.98 Forfeited or expired ― ― Performance-based outstanding at March 31, 2015 358 $ 8.29 Granted ― ― Exercised (15 ) 5.17 Forfeited or expired (30 ) 9.15 Performance-based outstanding at June 30, 2015 313 $ 8.36 Granted 154 8.83 Exercised (15 ) 5.56 Forfeited or expired (8 ) 4.66 Performance-based outstanding at September 30, 2015 444 $ 8.69 The September 30, 2015 remaining expense amount is expected to be recognized, at the time of the grant vesting, over the period ending in first quarter 2016. Under the PA32540 and PA8140 incentive programs, there were 122,000 unvested performance-based options outstanding at September 30, 2015. No performance-based awards vested during the nine months ended September 30, 2015 and September 30, 2014. There were 444,000 and 243,000 vested performance-based options outstanding at September 30, 2015 and September 30, 2014, respectively. There were 37,000 awards forfeited during the nine months ended September 30, 2015 and 88,000 awards forfeited during the nine months ended September 30, 2014. A total of 40,000 performance-based awards were exercised during the nine months ended September 30, 2015 and 32,000 performance-based awards were exercised during the nine months ended September 30, 2014. At September 30, 2015, the performance-based options had an intrinsic value of $1.5 million and a remaining weighted contractual life of 6.2 years. Net Income (Loss) Per Share Reconciliation of denominators for basic and diluted earnings per share computations: Three months ended September 30, Nine months ended September 30, 2015 2014 2015 2014 Basic weighted average shares outstanding 32,732,686 31,589,192 32,476,358 31,118,572 Effect of dilutive employee and director awards ― 1,360,587 ― 1,495,479 Diluted weighted-average shares outstanding and assumed conversions 32,732,686 32,949,779 32,476,358 32,614,051 If there is any change in the number or kind of shares of company stock outstanding or if the value of outstanding shares of company stock is substantially reduced as a result of an extraordinary dividend or distribution, the Company’s 2010 Stock Option Plan requires that an equitable adjustment be made to all outstanding grants to preclude dilution of rights and benefits under the plan. Therefore, as a result of the December 31, 2013 cash dividend distribution, a dividend equivalent was provided to all outstanding grants. The adjustments were in the form of additional RSUs to RSU holders or an adjustment to both the outstanding number of options and their strike price; all adjustments were made in compliance with Sections 409A and 424 of the Internal Revenue Code. In addition, the 2010 Stock Option Plan provides for an adjustment to the number of common shares available for grant under the stock option plan. Therefore, as a result of the December 31, 2013 cash dividend distribution, the number of common shares available for grant was adjusted by 416,971 shares and that increase is reflected in the table below. At September 30, 2015, shares of our common stock reserved for future issuance are as follows: Common shares available for grant under stock option plans 2,163,703 Common shares issuable pursuant to options and restricted stock units granted under equity compensations plans 6,709,036 Rights Plan shares issuable as Series A Junior Participating Preferred Stock 90,000 Total Reserved 8,962,739 Leases— New Accounting Pronouncements — Revenue from Contracts with Customers: Contingencies , asserting only the ‘907 patent against Dr. Reddy’s. An amended complaint was filed on October 28, 2011 On December 19, 2012, the District Court conducted a pre-trial “Markman” hearing to determine claim construction. On May 1, 2013, the Court issued a Markman Order construing the claim terms disputed by the parties. On April 15, 2013 a Stipulation of Partial Dismissal was filed which sought dismissal of all infringement claims relating to the '504 patent, the '085 patent, the '872 patent, the '070 patent, and the '466 patent (which are each assigned to AstraZeneca), as well as Dr. Reddy’s defenses and counterclaims relating to those patents. On April 18, 2013, the District Court issued a Stipulation and Order dismissing with prejudice those claims and defenses. The first Dr. Reddy’s case is considered the lead case and has been consolidated with the other actions as described below for the purpose of pre-trial and discovery. A scheduling order for this case, and all of the consolidated cases, was issued by the Court on June 27, 2014. Fact discovery closed in the consolidated case on November 20, 2014 and expert discovery closed on June 25, 2015. In view of the retirement of presiding Judge Pisano, on February 9, 2015, the consolidated cases were reassigned to Judge Mary L. Cooper. On June 13, 2011, we and AstraZeneca received a Paragraph IV Notice Letter from Lupin Ltd., or Lupin, informing us that Lupin had filed an ANDA with the FDA seeking regulatory approval to market a generic version of VIMOVO before the expiration of the ‘907 patent, which is assigned to POZEN and the ‘504 patent, the '085 patent, the '872 patent, the '070 patent, and the '466 patent, each of which are assigned to AstraZeneca or its affiliates. The patents are listed with respect to VIMOVO in the Orange Book and expire at various times betw |
Summary of Significant Account8
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2015 | |
Summary of Significant Accounting Policies [Abstract] | |
Use of Estimates | Use of Estimates— |
Accrued expenses, including contracted costs | Accrued expenses, including contracted costs— The Company believes that its current assumptions and other considerations used to estimate accrued expenses for the period are appropriate. However, determining the date on which certain contract services commence, the extent of services performed on or before a given date and the cost of such, paid and unpaid, involves subjective judgments and estimates and often must be based upon information provided by third parties. In the event that management does not identify certain contract costs which have begun to be incurred or under- or over-estimates the extent of services performed or the costs of such services, management adjusts costs during the period in which the information becomes available. Accrued costs related to product development and operating activities, based upon the progress of these activities covered by the related contracts, invoices received and estimated costs totaled $5.2 million at September 30, 2015 and $0.3 million at December 31, 2014. The variance, at each of these ending periods, between the actual expenses incurred and the estimated expenses accrued was not material or significant. |
Accrued Employee Compensation | Accrued Employee Compensation— In June 2015, we announced the adoption of an employee severance plan to provide severance benefits to eligible employees terminated involuntarily under certain circumstances. Under the plan these employees will be paid on-going payments of approximately $4.2 million. Employees are required to render service beyond a minimum period; therefore, such benefits are being accrued over the respective service period. The first payment was made in November 2015 and payments will continue through September 2017. Through the quarter ended September 30, 2015, $470,000 was recorded as R&D expense and $1.2 million was recorded as selling, general and administrative expense. Since no cash payment were incurred through the quarter ended September 30, 2015, the 2015 expense was recorded as accrued compensation. |
Revenue Recognition | Revenue Recognition— With regard to royalty revenues, the Company’s licensing agreements have terms that include royalty payments based on the manufacture, sale or use of the Company’s products or technology. VIMOVO ® Also, with regard to the licensing revenues, the Company’s licensing agreements have had terms that include upfront payments upon contract signing and additional payments if and when certain milestones in the product’s development or commercialization are reached. Historically, the non-refundable portion of upfront payments received under the Company’s existing agreements is deferred by the Company upon receipt and recognized on a straight-line basis over periods ending on the anticipated date of regulatory approvals, as specified in the agreements relating to the product candidates, or the conclusion of any obligation on the part of the Company. If regulatory approvals or other events relating to our product candidates are accelerated, delayed or not ultimately obtained, then the amortization of revenues for these products is prospectively accelerated or reduced accordingly. Milestone payments along with the refundable portions of up-front payments are recognized as licensing revenue upon the achievement of specified milestones if (i) the milestone is substantive in nature and the achievement of the milestone was not reasonably assured at the inception of the agreement; and (ii) the fees are non-refundable. Any milestone payments received prior to satisfying these revenue recognition criteria are recorded as deferred revenue. In September 2013, the Company announced the signing of an exclusive license agreement for its PA products with Sanofi U.S., including, PA8140 and PA32540, in the United States to commercialize all PA combinations that contain 325 mg or less of enteric-coated aspirin in the United States. On November 29, 2014, we executed a termination agreement with Sanofi U.S. terminating the license. As of the termination date, all licenses granted to Sanofi U.S. were terminated and all rights to the products licensed to Sanofi U.S. under the agreement reverted to us. The Company received an upfront payment of $15.0 million which was included within the license revenue and was completely amortized by the end of the 2014 fiscal year. The licensing revenue for the three and nine months ended September 30, 2014 was $2.0 million and $7.0 million, respectively. On March 21, 2011, the Company entered into a license agreement with Cilag GmbH International (“Cilag”) a division of Johnson & Johnson, for the exclusive development and commercialization of MT 400 in Brazil, Colombia, Ecuador and Peru. Cilag’s upfront payment of $257,300 was deferred until the licensing agreement’s termination on December 22, 2014 and was included in other licensing revenue for the fiscal year ended December 31, 2014. |
Income Taxes | Income Taxes— The accounting estimates used to compute the interim provision for income taxes may change as new events occur, additional information is obtained, or the tax environment changes. Since our inception, we have incurred substantial cumulative losses and may incur recurring losses in future periods. The utilization of these loss carryforwards to reduce future income taxes will depend on the Company’s ability to generate sufficient taxable income prior to the expiration of the loss carryforwards. In addition, the maximum annual use of net operating loss and research credit carryforwards is limited in certain situations where changes occur in stock ownership. We currently file income tax returns in the U.S. federal jurisdiction, and the state of North Carolina. We are no longer subject to federal or North Carolina income tax examinations by tax authorities for years before 2012. However, the loss carryforwards generated prior to 2012 may still be subject to change, if we subsequently begin utilizing these losses in a year that is open under statute and subject to federal or North Carolina income tax examinations by tax authorities. On May 21, 2015, the Company formed Pozen Limited, which was organized under the laws of Ireland, for the purpose of acquiring the rights to commercialize Yosprala, Treximet and MT 400. On May 27, 2015, the Company and Pozen Limited entered into an intercompany license agreement whereby the Company granted Pozen Limited a non-exclusive right to exercise certain product technologies and related intangible rights with respect to Yosprala, Treximet and MT 400. In consideration of the grant of the non-exclusive license, Pozen Limited made a fixed royalty payment and will pay additional contingent royalty payments to the Company. As a result of the intercompany license arrangement, the Company may utilize certain of its existing deferred tax assets to reduce current year income resulting from the transaction. As of September 30, 2015, no cash payment has been made relative to the intercompany license agreement. At the time cash payment is made, the Company may be subject to withholding taxes. No provision has been made for these future potential withholding tax obligations. At September 30, 2015, we had no unrecognized tax benefits that would reduce the Company’s effective tax rate if recognized. We recognize any interest and penalties accrued related to unrecognized tax benefits as income tax expense. During the nine months ended September 30, 2015 and 2014, there were no such interest and penalties. The Company currently anticipates being able to utilize existing US tax attributes to offset expected US taxable income in 2015, including US taxable income resulting from the intercompany license agreement with POZEN Limited. The Company believes that should the proposed business combination with Tribute Pharmaceuticals Canada Inc. be completed as anticipated within the next twelve months, it is reasonably possible that an unrecognized tax benefit of $17M to $19M related to utilization of these US tax attributes may be established. Additionally, the Company may determine it necessary to make future cash payments of these amounts. The establishment of this unrecognized tax position would impact our effective tax rate. |
Cash, Cash Equivalents, Investments and Concentration of Credit Risk | Cash, Cash Equivalents, Investments and Concentration of Credit Risk — The Company invests in high-credit quality investments in accordance with its investment policy, which attempts to minimize the possibility of loss. However, cash and cash equivalents include financial instruments that potentially subject the Company to a concentration of credit risk. Cash and cash equivalents are of a highly liquid nature and are held with high credit quality financial institutions and money market mutual fund managers. Cash held directly with financial institutions is insured up to $250,000 per account and any excess amounts are uninsured. Cash is also held in insured bank deposits through a cash management program that offers a bank network ensuring full FDIC insurance on all deposits. The Company’s cash and cash equivalents are held in fully insured bank deposits and approximately 5% by money market mutual fund managers. In connection with its acquisition of all rights, title and interest to develop, commercialize and sell Treximet ® The following table sets forth our financial instruments carried at fair value as of September 30, 2015 and December 31, 2014: Financial Instruments Carried at Fair Value September 30, 2015 December 31, 2014 Assets: Cash and cash equivalents $ 36,991,056 $ 40,582,415 Investments in Pernix warrants ― 2,678,773 Total cash and investments $ 36,991,056 $ 43,261,188 Fair Value of Financial Instruments Financial instruments consist of cash and cash equivalents, short-term investments, accounts receivable and accounts payable. The carrying values of these amounts approximate the fair value due to their short-term nature. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Financial instruments consist of cash and cash equivalents, short-term investments, accounts receivable and accounts payable. The carrying values of these amounts approximate the fair value due to their short-term nature. |
Fair Value Measurement | Fair Value Measurement The Company defines fair value (“FV”) as the price that would be received to sell an asset or paid to transfer a liability ("the exit price") in an orderly transaction between market participants at the measurement date. The FV hierarchy for inputs maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available. The Company uses the following hierarchy of inputs to measure FV: ☐ Level 1 - quoted prices in active markets for identical assets and liabilities. ☐ Level 2 - observable inputs other than quoted prices in active markets for identical assets and liabilities, including quoted prices in active markets for instruments that are similar or quoted prices in markets that are not active for identical or similar instruments and model-derived valuations in which all significant inputs and value drivers are observable in active markets. ☐ Level 3 - unobservable inputs that are significant to the overall valuation, for which there is little or no market data available and which require the Company to develop its own assumptions. The Company values investments using the most observable inputs available that are current as of the measurement date and classifies them according to the lowest level of inputs used. Observable inputs are inputs that market participants would use in pricing the asset or liability developed from market data obtained from independent sources. Unobservable inputs are inputs that reflect the Company’s judgment concerning the assumptions that market participants would use in pricing the asset or liability developed from the best information available under the circumstances. The financial assets for which we perform recurring measurements are cash equivalents and investments in warrants. As of September 30, 2015, financial assets utilizing Level 1 inputs included cash equivalents. Financial assets utilizing Level 2 inputs included investments in warrants. Fair value is a market-based measure considered from the perspective of a market participant who holds the asset or owes the liability rather than an entity-specific measure. Therefore, even when market assumptions are not readily available, our own assumptions are set to reflect those that market participants would use in pricing the asset or liability at the measurement date. Our Level 1 valuations are based on the market approach and consist primarily of quoted prices for identical items on active securities exchanges. Our Level 2 valuations may also use the market approach and are based on significant other observable inputs such as quoted prices for financial instruments not traded on a daily basis. We did not rely on Level 3 input for valuation of our securities at September 30, 2015. |
Stock Plans | Stock Plans In 1996, the Company established a Stock Option Plan (the “Option Plan”) and authorized the issuance of options to attract and retain quality employees and to allow such employees to participate in the growth of the Company. In June 2000, the stockholders approved the POZEN Inc. 2000 Equity Compensation Plan (the “2000 Plan”) and the 2000 Plan became effective upon the completion of the Company’s initial public offering in October 2000, after which time no further grants were made under the Option Plan. In May 2004, the stockholders approved an amendment to and restatement of the 2000 Plan. The amendment to the 2000 Plan provided for an increase in the number of shares of common stock authorized for issuance under the 2000 Plan from 3,000,000 to 5,500,000 shares. In June 2007, the stockholders approved the amendment and restatement of the 2000 Plan to, among other things, increase the number of shares authorized for issuance under the 2000 Plan to 6,500,000 shares and continue the various performance criteria for use in establishing specific vesting targets for certain awards. In June 2010, stockholders approved the POZEN Inc. 2010 Equity Compensation Plan, (“the 2010 Plan”), a successor incentive compensation plan to the 2000 Plan which was merged with and into the 2010 Plan and all grants outstanding under the 2000 Plan were issued or transferred under the 2010 Plan. The 2010 Plan provides for grants of incentive stock options, nonqualified stock options, stock awards, and other stock-based awards, such as restricted stock units and stock appreciation rights (“SARs”), to employees, non-employee directors, and consultants and advisors who perform services for us and our subsidiaries. The 2010 Plan authorizes up to 7,452,327 shares of common stock for issuance, which includes 2,000,000 shares of our common stock which were in excess of the number of shares previously reserved under the 2000 Plan. The maximum number of shares for which any individual may receive grants in any calendar year is 1,000,000 shares. The Compensation Committee of the Board of Directors, which administers the 2010 Plan, will determine the terms and conditions of options, including when they become exercisable. Neither our Board nor the Committee can amend the 2010 Plan or options previously granted under the Plan to permit a repricing of options or SARs, without prior stockholder approval. If options granted under the 2010 Plan expire or are terminated for any reason without being exercised, or if stock awards, performance units, or other stock-based awards are forfeited or otherwise terminate, the shares of common stock underlying the grants will again be available for awards granted under the 2010 Plan. As a result of a December 31, 2013 cash dividend distribution, a dividend equivalent totaling 987,000 shares was provided to all outstanding grants. The adjustments were in the form of additional RSUs to RSU holders or an adjustment to both the outstanding number of options and their strike price, in compliance with Sections 409A and 424 of the Internal Revenue Code. If the Merger becomes effective, we intend to terminate the 2010 Omnibus Equity Incentive Plan and no further grants will be made thereunder, and shares with respect to all grants outstanding under the 2010 Plan will be issued under or transferred to the Aralez Pharmaceuticals plc 2015 Long-Term Incentive Plan. Time-Based Stock Awards For the nine months ended September 30, 2015 and 2014, the Company recognized $517,000 and $720,000, respectively, in compensation expense related to time-base stock awards. No new time-based awards were granted during the nine months ended September 30, 2015 and September 30, 2014. Previously, the fair value of each time-based award was estimated on the date of grant using the Black-Scholes option valuation model. Historically, the expected volatility rate was estimated based on an equal weighting of the historical volatility of POZEN common stock over approximately a six-year period, the expected term was based upon average historical terms to exercise and the risk-free interest rate was based on six-year U.S. Treasury securities. The pre-vesting forfeiture rates used were also based on historical rates. We adjust the estimated forfeiture rate based upon actual experience. A summary of the time-based stock awards as of September 30, 2015, and changes during the nine months ended September 30, 2015, are as follows: Time-Based Stock Awards Underlying Shares (000s) Weighted-Average Exercise Price Average Remaining Contractual Term (years) Aggregate Intrinsic Value (000s) Outstanding at December 31, 2014 2,341 $ 7.39 4.1 $ 4,382 Granted ― ― Exercised (65 ) 4.09 Forfeited or expired ― ― Outstanding at March 31, 2015 2,277 7.48 3.8 $ 3,796 Exercisable at March 31, 2015 2,095 $ 7.79 3.5 $ 3,098 Vested or expected to vest at March 31, 2015 2,249 $ 7.48 3.8 $ 3,751 Granted ― ― Exercised (582 ) 5.84 Forfeited or expired (33 ) 13.77 Outstanding at June 30, 2015 1,662 7.90 3.5 $ 5,467 Exercisable at June 30, 2015 1,480 $ 8.39 3.1 $ 4,300 Vested or expected to vest at June 30, 2015 1,634 $ 7.90 3.5 $ 5,377 Granted ― ― Exercised (68 ) 4.95 Forfeited or expired (3 ) 3.87 Outstanding at September 30, 2015 1,591 8.03 3.2 $ 1,053 Exercisable at September 30, 2015 1,528 $ 8.20 3.0 $ 929 Vested or expected to vest at September 30, 2015 1,581 $ 8.03 3.2 $ 1,047 The aggregate intrinsic value of options outstanding represents the pretax value (the period’s closing market price, less the exercise price, times the number of in-the-money options) that would have been received by all option holders had they exercised their options at the end of the period. A total of 715,000 stock options were exercised during the nine months ended September 30, 2015 with an intrinsic value of $2.1 million, and a total of 994,000 stock options were exercised during the nine months ended September 30, 2014 with an intrinsic value of $2.7 million. A summary of the time-based nonvested awards as of September 30, 2015, and changes during the nine months ended September 30, 2015, are as follows: Underlying Shares (000s) Weighted-Average Exercise Price Nonvested outstanding at December 31, 2014 477 $ 3.85 Granted ― ― Forfeited or expired ― ― Vested (296 ) 4.47 Nonvested outstanding at March 31, 2015 181 $ 3.87 Granted ― ― Forfeited or expired ― ― Vested ― ― Nonvested outstanding at June 30, 2015 181 $ 3.87 Granted ― ― Forfeited or expired (3 ) 3.87 Vested (115 ) 3.87 Nonvested outstanding at September 30, 2015 63 $ 3.87 Restricted Stock and Restricted Stock Units For the nine months ended September 30, 2015 and 2014, the Company recognized $4.4 million and $770,000, respectively, in compensation expense related to restricted stock units. A summary of the restricted stock unit awards as of September 30, 2015, and changes during the nine months ended September 30, 2015, are as follows: Underlying Shares (000s) Weighted-Average Exercise Price Restricted stock outstanding at December 31, 2014 1,109 $ 7.14 Granted ― ― Vested and released (49 ) 7.17 Forfeited or expired ― ― Restricted stock outstanding at March 31, 2015 1,060 $ 7.14 Granted 3,543 7.76 Vested and released (37 ) 7.35 Forfeited or expired ― ― Restricted stock outstanding at June 30, 2015 4,566 $ 7.62 Granted 113 11.18 Vested and released ― ― Forfeited or expired (5 ) 7.22 Restricted stock outstanding at September 30, 2015 4,674 $ 7.70 As of September 30, 2015 there was an aggregate $27.9 million of unrecognized compensation expense related to unvested restricted stock units. Of the aggregate amount, $24.0 million unrecognized compensation expense related to unvested restricted stock units under the June 2015 award of 3,421,562 restricted stock units with a grant-date per-share fair value of $7.64. There were 3.9 million unvested restricted stock units outstanding at September 30, 2015 and 401,000 unvested restricted stock units outstanding at September 30, 2014. The total fair value of restricted stock that vested during the nine months ended September 30, 2015 and 2014 was $636,000 and $726,000, respectively. Performance-Based Awards In May 2008, pursuant to an incentive program (the “PN incentive program”) approved by the Compensation Committee of the Board of Directors of the Company, stock options were granted to all of the Company’s employees, including its executive officers, to purchase an aggregate of 281,433 shares of common stock with an exercise price of $14.45 per share. In September 2008, additional stock options were granted under the PN incentive program, to purchase 11,700 shares of common stock at an exercise price of $10.82 per share. The stock options have a ten-year term and have an exercise price equal to the closing sale price of the Company’s common stock, as reported on the NASDAQ Global Market, on the date of grant. Twenty-five percent (25%) of the PN incentive program options granted vested in 2009, upon completion of the performance goal and the remaining seventy-five percent (75%) of the options granted vested in 2010 upon the completion of the remaining performance goals. The fair value of the performance-based options granted under the PN incentive program was estimated as of the grant date using the Black-Scholes option valuation model without consideration of the performance measures. The options also include provisions that require satisfactory employee performance prior to vesting. Additionally, 20,000 options were granted to an executive officer in May 2008 under the PN incentive plan, with similar grant and exercise terms. The Company recognized compensation costs for these awards over the expected service period. In October 2011, pursuant to an incentive program (the “PA32540 incentive program”) approved by the Compensation Committee of the Board of Directors of the Company, stock options and RSUs were granted to all of the Company’s employees, including its executive officers, to purchase an aggregate of 453,960 shares of common stock. The underlying stock options and RSUs were performance-based and focus on the successful completion of certain value-enhancing events for the Company’s YOSPRALA product candidate. The stock options have a ten-year term and have an exercise price equal to the closing sale price of the Company’s common stock, as reported on the NASDAQ Global Market, on the date of grant. The underlying stock options and RSUs vested or will vest in accordance with the following schedule: (a) one-third (1/3) upon the acceptance of the filing of a new drug application (the “NDA”) for YOSPRALA, assuming the NDA filing is made prior to December 31, 2012, (b) one-third (1/3) upon first cycle NDA approval of YOSPRALA (otherwise 16.5% upon NDA approval after first cycle), and (c) one-third (1/3) upon execution of a significant partnering transaction for YOSPRALA in a major territory as determined by the Compensation Committee of the Company, in its sole discretion, at the time of such transaction, subject in each case to continued employment or service to the Company. During a pre-submission meeting with respect to its NDA for YOSPRALA in April 2012, the U.S. Food and Drug Administration, or FDA suggested that the Company also seek approval for a lower dose formulation of the product containing 81 mg of enteric coated aspirin as part of its NDA for YOSPRALA. The Company decided to include data and information relating to a lower dose formulation in its NDA. Generation of additional data with respect to lower dose formulation of YOSPRALA and incorporation of data into the NDA for YOSPRALA would delay submission of the NDA from the original planned submission date. Therefore, in October 2012, the Compensation Committee granted performance-based incentive awards (the “PA8140 incentive program”) both to compensate the employees for the expected loss of value under the PA32540 Incentive Program, as well as to provide additional incentive to employees to complete the value-added activities required for submission and approval of the lower dose product. The Compensation Committee granted an aggregate of 208,740 restricted stock units to various employees of the Company, including 105,000 restricted stock units granted to the Company’s named executive officers. The restricted stock units were performance-based and vested in accordance with the following schedule: (a) one-half (1/2) upon the acceptance by the FDA of the filing of an NDA for a lower dose YOSPRALA product candidate, and (b) one-half (1/2) upon approval by the FDA of an NDA for a lower dose YOSPRALA product candidate. In 2012, 132,883 options were forfeited in acknowledgement that certain performance goals would not be met under the PA32540 incentive program. In April 2014, the Compensation Committee granted an aggregate of 73,000 restricted stock units to various employees of the Company, including 65,000 restricted stock units granted to the Company’s named executive officers. The restricted stock units were performance-based and vested in accordance with the following schedule: (i) 50% upon receipt of the milestone payment by Sanofi U.S. under the License and Collaboration Agreement, dated as of September 3, 2013 (the "Agreement") to be received upon approval by the U.S. Food and Drug Administration of the PA product candidates; and (ii) 50% upon receipt of the milestone payment by Sanofi U.S. upon achievement of commercial readiness (as defined in the Agreement). The entire award was forfeited in 2014 upon the termination of the Sanofi U.S. agreement. In 2014, a total of 177,818 options were forfeited in acknowledgement that certain performance goals would not be met under the PA32540 and PA8140 incentive programs. As of September 30, 2015, there was $2,000 in unrecognized compensation expense related to performance-based awards granted under the PA32540 and PA8140 incentive programs. During the nine months ended September 30, 2015, the Company recognized $784,000 in compensation expense related to performance-based awards, of which $779,000 was recognized related to the performance-based stock awards vesting acceleration, as defined under the separation agreement with the Company’s former President and Chief Executive Officer. During the nine months ended September 30, 2014, there was expense of $425,000 recorded for performance-based awards. A summary of the performance-based stock awards as of September 30, 2015, and changes during the nine months ended September 30, 2015, are as follows: Underlying Shares (000s) Weighted-Average Exercise Price Performance-based outstanding at December 31, 2014 368 $ 8.12 Granted ― ― Exercised (10 ) 1.98 Forfeited or expired ― ― Performance-based outstanding at March 31, 2015 358 $ 8.29 Granted ― ― Exercised (15 ) 5.17 Forfeited or expired (30 ) 9.15 Performance-based outstanding at June 30, 2015 313 $ 8.36 Granted 154 8.83 Exercised (15 ) 5.56 Forfeited or expired (8 ) 4.66 Performance-based outstanding at September 30, 2015 444 $ 8.69 The September 30, 2015 remaining expense amount is expected to be recognized, at the time of the grant vesting, over the period ending in first quarter 2016. Under the PA32540 and PA8140 incentive programs, there were 122,000 unvested performance-based options outstanding at September 30, 2015. No performance-based awards vested during the nine months ended September 30, 2015 and September 30, 2014. There were 444,000 and 243,000 vested performance-based options outstanding at September 30, 2015 and September 30, 2014, respectively. There were 37,000 awards forfeited during the nine months ended September 30, 2015 and 88,000 awards forfeited during the nine months ended September 30, 2014. A total of 40,000 performance-based awards were exercised during the nine months ended September 30, 2015 and 32,000 performance-based awards were exercised during the nine months ended September 30, 2014. At September 30, 2015, the performance-based options had an intrinsic value of $1.5 million and a remaining weighted contractual life of 6.2 years. |
Net Income (Loss) Per Share | Net Income (Loss) Per Share Reconciliation of denominators for basic and diluted earnings per share computations: Three months ended September 30, Nine months ended September 30, 2015 2014 2015 2014 Basic weighted average shares outstanding 32,732,686 31,589,192 32,476,358 31,118,572 Effect of dilutive employee and director awards ― 1,360,587 ― 1,495,479 Diluted weighted-average shares outstanding and assumed conversions 32,732,686 32,949,779 32,476,358 32,614,051 If there is any change in the number or kind of shares of company stock outstanding or if the value of outstanding shares of company stock is substantially reduced as a result of an extraordinary dividend or distribution, the Company’s 2010 Stock Option Plan requires that an equitable adjustment be made to all outstanding grants to preclude dilution of rights and benefits under the plan. Therefore, as a result of the December 31, 2013 cash dividend distribution, a dividend equivalent was provided to all outstanding grants. The adjustments were in the form of additional RSUs to RSU holders or an adjustment to both the outstanding number of options and their strike price; all adjustments were made in compliance with Sections 409A and 424 of the Internal Revenue Code. In addition, the 2010 Stock Option Plan provides for an adjustment to the number of common shares available for grant under the stock option plan. Therefore, as a result of the December 31, 2013 cash dividend distribution, the number of common shares available for grant was adjusted by 416,971 shares and that increase is reflected in the table below. At September 30, 2015, shares of our common stock reserved for future issuance are as follows: Common shares available for grant under stock option plans 2,163,703 Common shares issuable pursuant to options and restricted stock units granted under equity compensations plans 6,709,036 Rights Plan shares issuable as Series A Junior Participating Preferred Stock 90,000 Total Reserved 8,962,739 |
Leases | Leases— |
New Accounting Pronouncements | New Accounting Pronouncements — Revenue from Contracts with Customers: |
Contingencies | Contingencies , asserting only the ‘907 patent against Dr. Reddy’s. An amended complaint was filed on October 28, 2011 On December 19, 2012, the District Court conducted a pre-trial “Markman” hearing to determine claim construction. On May 1, 2013, the Court issued a Markman Order construing the claim terms disputed by the parties. On April 15, 2013 a Stipulation of Partial Dismissal was filed which sought dismissal of all infringement claims relating to the '504 patent, the '085 patent, the '872 patent, the '070 patent, and the '466 patent (which are each assigned to AstraZeneca), as well as Dr. Reddy’s defenses and counterclaims relating to those patents. On April 18, 2013, the District Court issued a Stipulation and Order dismissing with prejudice those claims and defenses. The first Dr. Reddy’s case is considered the lead case and has been consolidated with the other actions as described below for the purpose of pre-trial and discovery. A scheduling order for this case, and all of the consolidated cases, was issued by the Court on June 27, 2014. Fact discovery closed in the consolidated case on November 20, 2014 and expert discovery closed on June 25, 2015. In view of the retirement of presiding Judge Pisano, on February 9, 2015, the consolidated cases were reassigned to Judge Mary L. Cooper. On June 13, 2011, we and AstraZeneca received a Paragraph IV Notice Letter from Lupin Ltd., or Lupin, informing us that Lupin had filed an ANDA with the FDA seeking regulatory approval to market a generic version of VIMOVO before the expiration of the ‘907 patent, which is assigned to POZEN and the ‘504 patent, the '085 patent, the '872 patent, the '070 patent, and the '466 patent, each of which are assigned to AstraZeneca or its affiliates. The patents are listed with respect to VIMOVO in the Orange Book and expire at various times between 2014 and 2023. Lupin’s Paragraph IV Notice Letter asserts that its generic product will not infringe the listed patents or that the listed patents are invalid or unenforceable. AstraZeneca has advised us that it has elected to exercise its first right to prosecute the infringement suit against Lupin and, accordingly, we and AstraZeneca filed suit against Lupin on July 25, 2011 in the United States District Court for the District of New Jersey. On November 19, 2014, an amended complaint was filed in which the '085 patent, the '872 patent, the '070 patent, and the '466 patent, all assigned to AstraZeneca or its affiliates, were not asserted against Lupin. On December 3, 2014, another amended complaint was filed in which the ‘504 patent, assigned to AstraZeneca or its affiliates, was not asserted against Lupin. The case is currently consolidated for discovery and pretrial purposes with the first filed Dr. Reddy’s case. On September 19, 2011, we and AstraZeneca received Paragraph IV Notice Letter from Anchen Pharmaceuticals, Inc., or Anchen, informing us that Anchen had filed an ANDA with the FDA seeking regulatory approval to market a generic version of VIMOVO before the expiration of the ‘907 patent, the '085 patent, the '070 patent, and the '466 patent. The patents are among those listed with respect to VIMOVO in the Orange Book and expire at various times between 2018 and 2023. Anchen’s Paragraph IV Notice Letter asserts that its generic product will not infringe those patents or that those patents are invalid or unenforceable. AstraZeneca has advised us that it has elected to exercise its first right to prosecute the infringement suit against Anchen and, accordingly, we and AstraZeneca filed suit against Anchen on October 28, 2011 in the United States District Court for the District of New Jersey. On October 4, 2013, Anchen filed an amendment to its ANDA seeking to change its Paragraph IV certification to a Paragraph III. It is not known to the Company when or if the FDA will enter Anchen’s amendment. On October 25, 2013, Anchen filed a Motion to Dismiss the case against it, based on its proposed re-certification. On November 18, 2013, On November 20, 2012 received a Paragraph IV Notice Letter from Dr. Reddy’s, that Dr. Reddy’s had filed a second ANDA with the FDA seeking regulatory approval to market a generic version of VIMOVO Dr. Reddy’s on its second ANDA filing Dr. Reddy’s January 4, 2013 On April 15, 2013 a Stipulation of Partial Dismissal was filed which sought dismissal of all infringement claims relating to the '504 patent, the '085 patent, the '872 patent, the '070 patent, and the '466 patent (which are each assigned to AstraZeneca), as well as Dr. Reddy’s defenses and counterclaims relating to those patents. On April 18, 2013, the District Court issued the Stipulation and Order dismissing with prejudice those claims and defenses. On November 4, 2013, On July 9, 2015, Dr. Reddy’s renewed its Motion for Summary Judgment that Dr. Reddy’s is currently consolidated for discovery and pretrial purposes with the first filed Dr. Reddy’s case. On March 29, 2013, we and AstraZeneca received a Paragraph IV Notice Letter from Watson Laboratories, Inc. – Florida, or Watson, now Actavis, informing us that it had filed an ANDA with the FDA seeking regulatory approval to market a generic version of VIMOVO before the expiration of the ‘907 patent, which is assigned to the Company, and the ‘504 patent, the '085 patent, the '872 patent, the '070 patent, and the '466 patent, each of which assigned to AstraZeneca or its affiliates. The patents are listed with respect to VIMOVO in the Orange Book and expire at various times between 2014 and 2023. Watson’s Paragraph IV Notice Letter asserts that its generic product will not infringe the listed patents or that the listed patents are invalid or unenforceable. AstraZeneca has advised us that it has elected to exercise its first right to prosecute the infringement suit against Watson. On May 10, 2013, we and AstraZeneca filed a patent infringement lawsuit against Watson in the U.S. District Court of New Jersey. On March 11, 2015, a Stipulation of Counts Related to Certain Patents was filed which sought dismissal of all infringement claims relating to the '504 patent, the '085 patent, the '872 patent, the '070 patent, and the '466 patent (which are each assigned to AstraZeneca), as well as Actavis’s defenses and counterclaims relating to those patents and the ‘424 patent. On April 9, 2015, the District Court issued a Stipulation and Order dismissing with prejudice those claims and defenses. The case is currently consolidated for discovery and pretrial purposes with the first filed Dr. Reddy’s case. On May 16, 2013, we and AstraZeneca received a Paragraph IV Notice Letter from Mylan Pharmaceuticals Inc., or Mylan informing us that it had filed an ANDA with the FDA seeking regulatory approval to market a generic version of VIMOVO before the expiration of the ‘907 patent, which is assigned to the Company and the ‘504 patent, the '085 patent, the ‘424 patent, the '872 patent, the '070 patent, and the '466 patent, each of which is assigned to AstraZeneca or its affiliates. The patents are listed with respect to VIMOVO in the Orange Book and expire at various times between 2014 and 2023. Mylan’s Paragraph IV Notice Letter asserts that its generic product will not infringe the listed patents or that the listed patents are invalid or unenforceable. AstraZeneca advised us that it had elected to exercise its first right to prosecute the infringement suit against Mylan. On June 28, 2013, we and AstraZeneca filed a patent infringement lawsuit against Mylan in the U.S. District Court of New Jersey. On February 13, 2015, the Court entered a Joint Stipulation of Dismissal of Counts Related to Certain Patents, dismissing claims related to the ‘504 patent, the '085 patent, the ‘424 patent, the '872 patent, the '070 patent, and the '466 patent, each of which is assigned to AstraZeneca or its affiliates. The case is currently consolidated for discovery and pretrial purposes with the first filed Dr. Reddy’s case. On October 15, 2013, the United States Patent Office issued U.S. Patent No. 8,555,285 (the “’285 patent”). The ‘285 patent, entitled “Pharmaceutical compositions for the coordinated delivery of NSAIDs” and assigned to POZEN, is related to the ‘907 patent. AstraZeneca advised us that it elected to exercise its first right to prosecute the infringement of the ‘285 patent and, accordingly, on October 23, 2013, we, and AstraZeneca filed patent infringement lawsuits against Dr. Reddy’s, Lupin, Watson and Mylan in the U.S. District Court of New Jersey alleging that their ANDA products infringe the ‘285 patent. On November 8, 2013, we, and AstraZeneca filed a Motion to Amend the Complaint in the actions against Dr. Reddy’s, Lupin, Watson and Mylan or, in the alternative, to consolidate the actions involving the ‘285 patent with the existing consolidated action. Dr. Reddy’s, Lupin, Watson and Mylan have each filed answers to the respective amended complaints, thus adding claims relating to the ‘285 patent against each of the Defendants to the consolidated case . As part of the purchase of all of AstraZeneca’s rights, title and interest to develop, commercialize and sell VIMOVO in the United States, Horizon has assumed AstraZeneca’s right to lead the above-described Paragraph IV litigation relating to VIMOVO currently pending in the United States District Court for the District of New Jersey and has assumed patent-related defense costs relating to such litigation, including reimbursement up to specified amounts of the cost of any counsel retained by us. On December 12, 2013, Horizon filed Motions to Join under Fed.R.Civ.Proc. 25(c) as a co-plaintiff in each of the above referenced actions and the consolidated action. On January 31, 2014, February 2, 2014, and February 20, 2014, the Court granted Horizon’s motions. On October 7, 2014, the United States Patent Office issued United States Patent No. 8,852,636 (“the ‘636 patent”). The ‘636 patent, entitled “Pharmaceutical compositions for the coordinated delivery of NSAIDs” and assigned to POZEN, is related to the ‘907 and ‘285 patents. On October 14, 2014, the United States Patent Office issued United States Patent No. 8,858,996 (“the ‘996 patent”). The ‘996 patent, entitled “Pharmaceutical compositions for the coordinated delivery of NSAIDs” and assigned to POZEN, is also related to the ‘907 and ‘285 patents. On October 21, 2014, the United States Patent Office issued United State Patent No. 8,865,190 (“the ‘190 patent”). The ‘190 patent, entitled “Pharmaceutical compositions for the coordinated delivery of NSAIDs” and assigned to POZEN, is related to the ‘907 and ‘285 patents. Horizon has advised us that it has elected to exercise its first right to prosecute the infringement of the ‘636, ‘996 and ‘190 patents and, accordingly, on May 13, 2015, we, and Horizon filed patent infringement lawsuits against Dr. Reddy’s, Lupin, Actavis and Mylan in the U.S. District Court of New Jersey alleging that their ANDA products infringe the ‘636 and ‘996 patents. On June 18, 2013, we, and Horizon filed an Amended Complaint in the actions against Dr. Reddy’s, Lupin, Watson and Mylan, adding the ‘190 patent to the case. The cases are in the initial phase. A Scheduling Conference was held on October 27, 2015. On February 24, 2015, Dr. Reddy’s filed a Petition for Inter Partes Review ("IPR") of the ’285 patent with the Patent Trials and Appeals Board (“PTAB”) of the U.S. Patent and Trademark Office. We and Horizon filed a Preliminary Response on July 13, 2015. On October 9, 2015, the PTAB denied Dr. Reddy’s Petition. On May 21, 2015, the Coalition for Affordable Drugs VII L.L.C., or CFAD, filed a Petition for IPR of the ’907 patent with the PTAB of the U.S. Patent and Trademark Office. On September 18, 2015, we and Horizon filed a Preliminary Response. The PTAB has three months from the date of the Preliminary Response in which to institute or deny the IPR proceeding. If the PTAB decides to institute the IPR proceeding, CFAD will have the opportunity to challenge the validity of the ’907 patent in whole or in part before the PTAB via a patent validity trial. We and Horizon intend to defend the validity of the ’907 patent in both the IPR and district court settings. On June 5, 2015, CFAD filed a Petition for IPR of the’966 patent with the PTAB of the U.S. Patent and Trademark Office. On September 18, 2015, we and Horizon filed a Preliminary Response. Upon receipt of such a Preliminary Response, the PTAB has three months from the date of the Preliminary Response in which to institute or deny the IPR proceeding. If the PTAB decides to institute the IPR proceeding, CFAD will have the opportunity to challenge the validity of the ’966 patent in whole or in part before the PTAB via a patent validity trial. We and Horizon intend to defend the validity of the ’966 patent in both the IPR and district court settings. On August 7, 2015, CFAD filed a Petition for IPR of the ‘636 patent with the PTAB of the U.S. Patent and Trademark Office. We and Horizon may file an optional Preliminary Response by November 17, 2015. Upon receipt of such a Preliminary Response, the PTAB has three months in which to institute or deny the IPR proceeding. If the PTAB decides to institute the IPR proceeding, CFAD will have the opportunity to challenge the validity of the ‘636 patent in whole or in part before the PTAB via a patent validity trial. We and Horizon intend to defend the validity of the ’636 patent in both the IPR and district court settings. On August 12, 2015, CFAD filed a Petition for IPR of the ‘621 patent with the PTAB of the U.S. Patent and Trademark Office. We and Horizon may file an optional Preliminary Response by November 24, 2015. Upon receipt of such a Preliminary Response, the PTAB has three months in which to institute or deny the IPR proceeding. If the PTAB decides to institute the IPR proceeding, CFAD will have the opportunity to challenge the validity of the ‘621 patent in whole or in part before the PTAB via a patent validity trial. We and Horizon intend to defend the validity of the ’621 patent in both the IPR and district court settings. On August 19, 2015, Lupin filed three Petitions for IPR, seeking review of the ‘996, ‘636 and ‘190 patents with the PTAB of the U.S. Patent and Trademark Office. We and Horizon may file an optional Preliminary Responses by November 28, 2015. Upon receipt of each Preliminary Response, the PTAB has three months in which to institute or deny the respective IPR proceeding. If the PTAB decides to institute the IPR proceeding, Lupin will have the opportunity to challenge the validity of the respective patents in whole or in part before the PTAB via a patent validity trial. We and Horizon intend to defend the validity of the ‘996, ‘636 and ‘190 patents in both the IPR and district court settings. In Canada, on January 20, 2015, AstraZeneca Canada Inc., or AstraZeneca Canada, received a Notice of Allegation from Mylan Pharmaceuticals ULC, or Mylan Canada, informing that Mylan Canada has filed an Abbreviated New Drug Submission or, ANDS, in Canada for approval of its naproxen/esomeprazole magnesium tablets and alleging non-infringement of some of the claims and invalidity of POZEN’s Canadian Patent No. 2,449,098 (the “'098 patent”). AstraZeneca Canada is the licensee pursuant to a Collaboration Agreement with us, and the '098 patent is listed in respect of AstraZeneca Canada’s VIMOVO products. A Notice of Allegation in Canada is similar to a Paragraph IV Notice Letter in the United States, and in response, we and AstraZeneca Canada, as the patentee, commenced a proceeding in the Federal Court of Canada in relation to the '098 patent on March 5, 2015. The Canadian proceeding is summary in nature and expected to be completed before March 5, 2017. The current schedule as approved by the Court provides for the service of affidavit evidence of AstraZeneca Canada and POZEN by September 11, 2015 and affidavit evidence of Mylan Canada by January, 8, 2016. The parties are to complete cross-examinations on the affidavit evidence by April 29, 2016. The Written Records for the hearing are to be served by AstraZeneca and POZEN by July 4, 2016 and by Mylan Canada by September 2, 2016. A three day hearing of the matter has been scheduled to begin on November 21, 2016. . The proceeding will decide whether approval for Mylan Canada’s naproxen/esomeprazole magnesium tablets will be prohibited until the expiry of the '098 patent because none of Mylan Canada’s allegations in respect of the '098 patent are justified; the proceeding will not finally decide '098 patent validity or infringement. The '098 patent expires on May 31, 2022. On April 24, 2015, we and Horizon received a third Paragraph IV Notice Letter from Dr. Reddy’s Dr. Reddy’s amended certifications relate to Dr. Reddy’s On June 1, 2015, we and Horizon received a second Paragraph IV Notice Letter from Actavis Actavis’ amended certifications relate to Actavis’s On July 17, 2015, we and Horizon received a second Paragraph IV Notice Letter from Lupin Lupin’s amended certifications relate to Lupin’s On October 12, 2015, we and Horizon received a third Paragraph IV Notice Letter from Actavis Actavis’ amended certifications relate to Actavis’s As with any litigation proceeding, we cannot predict with certainty the patent infringement suit against Dr. Reddy’s, Lupin, Mylan and Watson relating to a generic version of VIMOVO. We have incurred an aggregate of $18.2 million in legal fees through September 30, 2015 related to our intellectual property litigation. Furthermore, we will have to incur additional expenses in connection with the lawsuits relating to VIMOVO, which may be substantial. In the event of an adverse outcome or outcomes, our business could be materially harmed. Moreover, responding to and defending pending litigation will result in a significant diversion of management’s attention and resources and an increase in professional fees. |
Summary of Significant Account9
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Summary of Significant Accounting Policies [Abstract] | |
Financial Instruments Carried at Fair Value | The following table sets forth our financial instruments carried at fair value as of September 30, 2015 and December 31, 2014: Financial Instruments Carried at Fair Value September 30, 2015 December 31, 2014 Assets: Cash and cash equivalents $ 36,991,056 $ 40,582,415 Investments in Pernix warrants ― 2,678,773 Total cash and investments $ 36,991,056 $ 43,261,188 |
Summary of Time-Based Stock Awards | A summary of the time-based stock awards as of September 30, 2015, and changes during the nine months ended September 30, 2015, are as follows: Time-Based Stock Awards Underlying Shares (000s) Weighted-Average Exercise Price Average Remaining Contractual Term (years) Aggregate Intrinsic Value (000s) Outstanding at December 31, 2014 2,341 $ 7.39 4.1 $ 4,382 Granted ― ― Exercised (65 ) 4.09 Forfeited or expired ― ― Outstanding at March 31, 2015 2,277 7.48 3.8 $ 3,796 Exercisable at March 31, 2015 2,095 $ 7.79 3.5 $ 3,098 Vested or expected to vest at March 31, 2015 2,249 $ 7.48 3.8 $ 3,751 Granted ― ― Exercised (582 ) 5.84 Forfeited or expired (33 ) 13.77 Outstanding at June 30, 2015 1,662 7.90 3.5 $ 5,467 Exercisable at June 30, 2015 1,480 $ 8.39 3.1 $ 4,300 Vested or expected to vest at June 30, 2015 1,634 $ 7.90 3.5 $ 5,377 Granted ― ― Exercised (68 ) 4.95 Forfeited or expired (3 ) 3.87 Outstanding at September 30, 2015 1,591 8.03 3.2 $ 1,053 Exercisable at September 30, 2015 1,528 $ 8.20 3.0 $ 929 Vested or expected to vest at September 30, 2015 1,581 $ 8.03 3.2 $ 1,047 |
Summary of Time-Based Nonvested Awards | A summary of the time-based nonvested awards as of September 30, 2015, and changes during the nine months ended September 30, 2015, are as follows: Underlying Shares (000s) Weighted-Average Exercise Price Nonvested outstanding at December 31, 2014 477 $ 3.85 Granted ― ― Forfeited or expired ― ― Vested (296 ) 4.47 Nonvested outstanding at March 31, 2015 181 $ 3.87 Granted ― ― Forfeited or expired ― ― Vested ― ― Nonvested outstanding at June 30, 2015 181 $ 3.87 Granted ― ― Forfeited or expired (3 ) 3.87 Vested (115 ) 3.87 Nonvested outstanding at September 30, 2015 63 $ 3.87 |
Summary of Restricted Stock Awards | A summary of the restricted stock unit awards as of September 30, 2015, and changes during the nine months ended September 30, 2015, are as follows: Underlying Shares (000s) Weighted-Average Exercise Price Restricted stock outstanding at December 31, 2014 1,109 $ 7.14 Granted ― ― Vested and released (49 ) 7.17 Forfeited or expired ― ― Restricted stock outstanding at March 31, 2015 1,060 $ 7.14 Granted 3,543 7.76 Vested and released (37 ) 7.35 Forfeited or expired ― ― Restricted stock outstanding at June 30, 2015 4,566 $ 7.62 Granted 113 11.18 Vested and released ― ― Forfeited or expired (5 ) 7.22 Restricted stock outstanding at September 30, 2015 4,674 $ 7.70 |
Summary of Performance-Based Stock Awards | A summary of the performance-based stock awards as of September 30, 2015, and changes during the nine months ended September 30, 2015, are as follows: Underlying Shares (000s) Weighted-Average Exercise Price Performance-based outstanding at December 31, 2014 368 $ 8.12 Granted ― ― Exercised (10 ) 1.98 Forfeited or expired ― ― Performance-based outstanding at March 31, 2015 358 $ 8.29 Granted ― ― Exercised (15 ) 5.17 Forfeited or expired (30 ) 9.15 Performance-based outstanding at June 30, 2015 313 $ 8.36 Granted 154 8.83 Exercised (15 ) 5.56 Forfeited or expired (8 ) 4.66 Performance-based outstanding at September 30, 2015 444 $ 8.69 |
Reconciliation of Denominators for Basic and Diluted Earnings per Share Computations | Reconciliation of denominators for basic and diluted earnings per share computations: Three months ended September 30, Nine months ended September 30, 2015 2014 2015 2014 Basic weighted average shares outstanding 32,732,686 31,589,192 32,476,358 31,118,572 Effect of dilutive employee and director awards ― 1,360,587 ― 1,495,479 Diluted weighted-average shares outstanding and assumed conversions 32,732,686 32,949,779 32,476,358 32,614,051 |
Common Shares Reserved for Future Issuance | At September 30, 2015, shares of our common stock reserved for future issuance are as follows: Common shares available for grant under stock option plans 2,163,703 Common shares issuable pursuant to options and restricted stock units granted under equity compensations plans 6,709,036 Rights Plan shares issuable as Series A Junior Participating Preferred Stock 90,000 Total Reserved 8,962,739 |
Significant Accounting Polici10
Significant Accounting Policies, Proposed Business Combination (Details) - $ / shares | Jun. 08, 2015 | Sep. 30, 2015 | Dec. 31, 2014 |
Proposed Business Combination with Tribute Pharmaceuticals Canada Inc. [Abstract] | |||
Nominal value of convertible shares (in dollars per share) | $ 0.001 | $ 0.001 | |
Tribute [Member] | Common Stock [Member] | |||
Proposed Business Combination with Tribute Pharmaceuticals Canada Inc. [Abstract] | |||
Conversion rate for outstanding shares (in shares) | 0.1455 | ||
Parent [Member] | Common Stock [Member] | |||
Proposed Business Combination with Tribute Pharmaceuticals Canada Inc. [Abstract] | |||
Nominal value of convertible shares (in dollars per share) | $ 0.001 | ||
Conversion rate for outstanding shares (in shares) | 1 | ||
Parent [Member] | Shareholders of POZEN [Member] | |||
Proposed Business Combination with Tribute Pharmaceuticals Canada Inc. [Abstract] | |||
Percentage of stockholder ownership of outstanding shares | 66.00% | ||
Parent [Member] | Shareholders of Tribute [Member] | |||
Proposed Business Combination with Tribute Pharmaceuticals Canada Inc. [Abstract] | |||
Percentage of stockholder ownership of outstanding shares | 34.00% |
Significant Accounting Polici11
Significant Accounting Policies, Facility Agreement (Details) - Lenders [Member] - Line of Credit Facility [Member] $ / shares in Units, $ in Millions | Jun. 08, 2015USD ($)$ / shares |
Facility Agreement [Abstract] | |
Aggregate principle amount of facility agreement | $ 275 |
Portion of principle made available for permitted acquisitions | 200 |
2.5% Senior Secured Convertible Promissory Note [Member] | |
Facility Agreement [Abstract] | |
Portion of princple in the form of 2.5% senior secured convertible promissory note | $ 75 |
Rate of senior secured convertible promissory note | 2.50% |
Senior secured convertible promissory note term | 6 years |
Conversion price (in dollars per share) | $ / shares | $ 9.54 |
Significant Accounting Polici12
Significant Accounting Policies, Subscription Agreement (Details) - Private Placement [Member] $ / shares in Units, $ in Millions | Jun. 08, 2015USD ($)Statement$ / shares |
Parent [Member] | |
Subscription Agreement [Abstract] | |
Value of shares for private placement | $ 75 |
Purchase price (in dollars per share) | $ / shares | $ 7.20 |
POZEN [Member] | |
Subscription Agreement [Abstract] | |
Number of registration statements to be filed with SEC | Statement | 2 |
Period for filing registration statements | 60 days |
Summary of Significant Accoun13
Summary of Significant Accounting Policies (Details) - USD ($) | Sep. 30, 2015 | May. 31, 2015 | Dec. 31, 2014 |
Accrued expenses, including contracted costs [Abstract] | |||
Accrued costs related to product development and operating activities | $ 5,200,000 | $ 300,000 | |
Accrued Employee Compensation [Abstract] | |||
Accrued employee compensation | 6,727,299 | $ 1,899,456 | |
Former Officer [Member] | Separation Agreement [Member] | |||
Accrued Employee Compensation [Abstract] | |||
One-time payment to former Chief Executive Officer | $ 2,000,000 | ||
On-going payments for a deferred compensation arrangement | $ 3,100,000 | ||
Deferred compensation payments incurred | 108,000 | ||
Employees [Member] | Employee Severance Plan [Member] | |||
Accrued Employee Compensation [Abstract] | |||
On-going payments for a deferred compensation arrangement | 4,200,000 | ||
Deferred compensation payments incurred | 0 | ||
Employees [Member] | Employee Severance Plan [Member] | Research and Development Expense [Member] | |||
Accrued Employee Compensation [Abstract] | |||
Accrued employee compensation | 470,000 | ||
Employees [Member] | Employee Severance Plan [Member] | Selling, General and Administrative Expenses [Member] | |||
Accrued Employee Compensation [Abstract] | |||
Accrued employee compensation | $ 1,200,000 |
Summary of Significant Accoun14
Summary of Significant Accounting Policies, Revenue Recognition (Details) - USD ($) | Mar. 21, 2011 | Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | Dec. 31, 2014 |
Licensing Revenue [Abstract] | ||||||
Royalty revenue | $ 5,800,000 | $ 5,500,000 | $ 15,400,000 | $ 15,500,000 | ||
Licensing revenue | $ 5,820,184 | 7,539,741 | $ 15,425,499 | 22,507,723 | ||
Cilag GmbH International [Member] | ||||||
Licensing Revenue [Abstract] | ||||||
Initial upfront license payment | $ 257,300 | |||||
Sanofil-aventis U.S. LLC [Member] | ||||||
Licensing Revenue [Abstract] | ||||||
Licensing revenue | $ 2,000,000 | $ 7,000,000 | $ 15,000,000 |
Summary of Significant Accoun15
Summary of Significant Accounting Policies, Income Taxes (Details) - USD ($) | 9 Months Ended | |
Sep. 30, 2015 | Sep. 30, 2014 | |
Income Taxes [Abstract] | ||
Cash payments for intercompany license agreement | $ 0 | |
Federal [Member] | ||
Income Taxes [Abstract] | ||
Effective tax rate | 4.29% | 0.00% |
Unrecognized tax benefits | $ 0 | |
Provision for future potential witholding tax obligations | 0 | |
Federal [Member] | Minimum [Member] | ||
Income Taxes [Abstract] | ||
Expected unrecognized tax benefit within the next 12 months from acquistion | 17,000,000 | |
Federal [Member] | Maximum [Member] | ||
Income Taxes [Abstract] | ||
Expected unrecognized tax benefit within the next 12 months from acquistion | $ 19,000,000 |
Summary of Significant Accoun16
Summary of Significant Accounting Policies, Cash, Cash Equivalents, Investments and Concentrations of Credit Risk (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Mar. 31, 2015 | Sep. 30, 2015 | Sep. 30, 2014 | Dec. 31, 2014 | |
Cash and Cash Equivalents and Concentration of Credit Risk [Abstract] | ||||
Cash, FDIC insured amount | $ 250,000 | |||
Percentage of insured cash held by market mutual fund managers | 5.00% | |||
Number of securities called by warrants | 500,000 | |||
Exercise price of warrants (in dollars per share) | $ 4.28 | |||
Proceeds from sale of warrants | $ 2,479,400 | $ 2,479,400 | $ 0 | |
Loss on sale of warrants | 199,373 | $ 0 | ||
Assets [Abstract] | ||||
Cash and cash equivalents | 36,991,056 | $ 40,582,415 | ||
Investments in Pernix warrants | 0 | 2,678,773 | ||
Total cash and investments | $ 36,991,056 | $ 43,261,188 |
Summary of Significant Accoun17
Summary of Significant Accounting Policies, Stock Plan (Details) - shares | 12 Months Ended | |||||
Dec. 31, 2013 | Dec. 31, 2010 | Sep. 30, 2015 | Jun. 30, 2007 | May. 31, 2004 | Jun. 30, 2000 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of additional shares authorized for issuance (in shares) | 416,971 | |||||
Pozen, Inc. 2000 Equity Compensation Plan [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of shares authorized for issuance (in shares) | 6,500,000 | 5,500,000 | 3,000,000 | |||
Pozen, Inc. 2010 Equity Compensation Plan [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of shares authorized for issuance (in shares) | 7,452,327 | |||||
Number of additional shares authorized for issuance (in shares) | 2,000,000 | |||||
Number of shares grants an individual may receive (in shares) | 1,000,000 | |||||
Pozen, Inc. 2010 Equity Compensation Plan [Member] | Other than Options [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of additional shares authorized for issuance (in shares) | 987,000 |
Summary of Significant Accoun18
Summary of Significant Accounting Policies, Time-Based Stock Awards (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Sep. 30, 2008 | May. 31, 2008 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Sep. 30, 2015 | Sep. 30, 2014 | Dec. 31, 2014 | |
Time-Based Stock Awards [Abstract] | ||||||||
Time-Based compensation expense | $ 5,673,287 | $ 1,914,614 | ||||||
Time-Based Awards [Roll Forward] | ||||||||
Granted (in shares) | 0 | 0 | 0 | |||||
Time based nonvested awards [Roll Forward] | ||||||||
Nonvested outstanding at beginning of period (in shares) | 181,000 | 181,000 | 477,000 | 477,000 | ||||
Granted (in shares) | 0 | 0 | 0 | |||||
Forfeited or expired (in shares) | (3,000) | 0 | 0 | |||||
Vested (in shares) | (115,000) | 0 | (296,000) | |||||
Nonvested outstanding at end of period (in shares) | 63,000 | 181,000 | 181,000 | 63,000 | 477,000 | |||
Time-Based Stock Awards [Member] | ||||||||
Time-Based Stock Awards [Abstract] | ||||||||
Time-Based compensation expense | $ 517,000 | $ 720,000 | ||||||
Expected term of volatility rate | 6 years | |||||||
Expected term of risk free interest rate | 6 years | |||||||
Stock options exercised (in shares) | 715,000 | 994,000 | ||||||
Total intrinsic value of stock options exercised | $ 2,000,000 | $ 2,700,000 | ||||||
Time-Based Awards [Roll Forward] | ||||||||
Outstanding at beginning of period (in shares) | 1,662,000 | 2,277,000 | 2,341,000 | 2,341,000 | ||||
Granted (in shares) | 0 | 0 | 0 | 0 | 0 | |||
Exercised (in shares) | (68,000) | (582,000) | (65,000) | |||||
Forfeited or expired (in shares) | (3,000) | (33,000) | 0 | |||||
Outstanding at end of period (in shares) | 1,591,000 | 1,662,000 | 2,277,000 | 1,591,000 | 2,341,000 | |||
Exercisable at end of period (in shares) | 1,528,000 | 1,480,000 | 2,095,000 | 1,528,000 | ||||
Vested or expected to vest at end of period (in shares) | 1,581,000 | 1,634,000 | 2,249,000 | 1,581,000 | ||||
Weighted Average Exercise Price [Roll Forward] | ||||||||
Outstanding at beginning of period (in dollars per share) | $ 7.90 | $ 7.48 | $ 7.39 | $ 7.39 | ||||
Granted (in dollars per share) | 0 | 0 | 0 | |||||
Exercised (in dollars per share) | 4.95 | 5.84 | 4.09 | |||||
Forfeited or expired (in dollars per share) | 3.87 | 13.77 | 0 | |||||
Outstanding at end of period (in dollars per share) | 8.03 | 7.90 | 7.48 | 8.03 | $ 7.39 | |||
Exercisable at end of period (in dollars per share) | 8.20 | 8.39 | 7.79 | 8.20 | ||||
Vested or expected to vest at end of year (in dollars per share) | $ 8.03 | $ 7.90 | $ 7.48 | $ 8.03 | ||||
Remaining Contractual Life and Aggregate Intrinsic Value [Abstract] | ||||||||
Outstanding, average remaining contractual term | 3 years 2 months 12 days | 3 years 6 months | 3 years 9 months 18 days | 4 years 1 month 6 days | ||||
Outstanding, aggregate intrinsic value | $ 1,053,000 | $ 5,467,000 | $ 3,796,000 | $ 1,053,000 | $ 4,382,000 | |||
Exercisable, average remaining contractual term | 3 years | 3 years 1 month 6 days | 3 years 6 months | |||||
Exercisable, aggregate intrinsic value | $ 929,000 | $ 4,300,000 | $ 3,098,000 | 929,000 | ||||
Vested or expected to vest, average remaining contractual term | 3 years 2 months 12 days | 3 years 6 months | 3 years 9 months 18 days | |||||
Vested and expected to vest, aggregate intrinsic value | $ 1,047,000 | $ 5,377,000 | $ 3,751,000 | $ 1,047,000 | ||||
Time based nonvested awards [Roll Forward] | ||||||||
Granted (in shares) | 0 | 0 | 0 | 0 | 0 | |||
Time-based nonvested awards, weighted average exercise price [Roll Forward] | ||||||||
Outstanding at beginning of period (in dollars per share) | $ 7.90 | $ 7.48 | $ 7.39 | $ 7.39 | ||||
Outstanding at end of period (in dollars per share) | 8.03 | 7.90 | 7.48 | 8.03 | $ 7.39 | |||
Nonvested Time-Based Stock Awards [Member] | ||||||||
Weighted Average Exercise Price [Roll Forward] | ||||||||
Outstanding at beginning of period (in dollars per share) | 3.87 | 3.87 | 3.85 | 3.85 | ||||
Outstanding at end of period (in dollars per share) | 3.87 | 3.87 | 3.87 | 3.87 | 3.85 | |||
Time-based nonvested awards, weighted average exercise price [Roll Forward] | ||||||||
Outstanding at beginning of period (in dollars per share) | 3.87 | 3.87 | 3.85 | 3.85 | ||||
Granted (in dollars per share) | 0 | 0 | 0 | |||||
Forfeited or expired (in dollars per share) | 3.87 | 0 | 0 | |||||
Vested (in dollars per share) | 3.87 | 0 | 4.47 | |||||
Outstanding at end of period (in dollars per share) | $ 3.87 | $ 3.87 | $ 3.87 | $ 3.87 | $ 3.85 | |||
Restricted Stock Units [Member] | ||||||||
Time-Based Stock Awards [Abstract] | ||||||||
Time-Based compensation expense | $ 4,400,000 | $ 770,000 | ||||||
Performance-Based Awards [Member] | ||||||||
Time-Based Stock Awards [Abstract] | ||||||||
Stock options exercised (in shares) | (40,000) | (32,000) | ||||||
PN Incentive Program [Member] | Performance-Based Awards [Member] | ||||||||
Weighted Average Exercise Price [Roll Forward] | ||||||||
Granted (in dollars per share) | $ 10.82 | $ 14.45 |
Summary of Significant Accoun19
Summary of Significant Accounting Policies, Restricted Stock and Restricted Stock Units (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||
Apr. 30, 2014 | Oct. 31, 2012 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Sep. 30, 2015 | Sep. 30, 2014 | |
Restricted Stock and Restricted Stock Units [Abstract] | |||||||
Share-based Compensation | $ 5,673,287 | $ 1,914,614 | |||||
Time-Based Stock Awards [Member] | |||||||
Restricted Stock and Restricted Stock Units [Abstract] | |||||||
Share-based Compensation | $ 517,000 | $ 720,000 | |||||
Restricted Stock Units [Member] | |||||||
Restricted Stock and Restricted Stock Units [Abstract] | |||||||
Nonvested awards outstanding at end of period (in shares) | 3,900,000 | 3,900,000 | 401,000 | ||||
Unrecognized stock-based compensation expense | $ 27,900,000 | $ 27,900,000 | |||||
Share-based Compensation | 4,400,000 | $ 770,000 | |||||
Total fair value of restricted stock that vested | $ 636,000 | $ 726,000 | |||||
Restricted Stock and Stock Units [Roll Forward] | |||||||
Awards outstanding at beginning of period (in shares) | 4,566,000 | 1,060,000 | 1,109,000 | 1,109,000 | |||
Granted (in shares) | 113,000 | 3,543,000 | 0 | ||||
Vested and released (in shares) | 0 | (37,000) | (49,000) | ||||
Forfeited or expired (in shares) | (5,000) | 0 | 0 | ||||
Awards outstanding at end of period (in shares) | 4,674,000 | 4,566,000 | 1,060,000 | 4,674,000 | |||
Restricted Stock Awards, Weighted-Average Exercise Price [Roll Forward] | |||||||
Outstanding at beginning of period (in dollars per share) | $ 7.62 | $ 7.14 | $ 7.14 | $ 7.14 | |||
Granted (in dollars per share) | 7.76 | 7.76 | 0 | ||||
Vested and released (in dollars per share) | 0 | 7.35 | 7.17 | ||||
Forfeited or expired (in dollars per share) | 7.22 | 0 | 0 | ||||
Outstanding at end of period (in dollars per share) | $ 7.70 | $ 7.62 | $ 7.14 | $ 7.70 | |||
Performance-Based Awards [Member] | |||||||
Restricted Stock and Stock Units [Roll Forward] | |||||||
Granted (in shares) | 73,000 | ||||||
Awards outstanding at end of period (in shares) | 444,000 | 444,000 | 243,000 | ||||
Performance-Based Awards [Member] | Executive Officer [Member] | |||||||
Restricted Stock and Stock Units [Roll Forward] | |||||||
Granted (in shares) | 105,000 | ||||||
Performance-Based Awards [Member] | Employees [Member] | |||||||
Restricted Stock and Stock Units [Roll Forward] | |||||||
Granted (in shares) | 208,740 | ||||||
June 2015 Award [Member] | Restricted Stock Units [Member] | |||||||
Restricted Stock and Restricted Stock Units [Abstract] | |||||||
Nonvested awards outstanding at end of period (in shares) | 3,421,562 | 3,421,562 | |||||
Unrecognized stock-based compensation expense | $ 24,000,000 | $ 24,000,000 | |||||
Grant-date fair value (in dollars per share) | $ 7.64 | $ 7.64 | |||||
PA Incentive Program [Member] | Performance-Based Awards [Member] | |||||||
Restricted Stock and Restricted Stock Units [Abstract] | |||||||
Unrecognized stock-based compensation expense | $ 2,000 | $ 2,000 |
Summary of Significant Accoun20
Summary of Significant Accounting Policies, Performance-Based Awards (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||||
Apr. 30, 2014 | Oct. 31, 2012 | Oct. 31, 2011 | Apr. 30, 2010 | Sep. 30, 2008 | May. 31, 2008 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Sep. 30, 2015 | Sep. 30, 2014 | Dec. 31, 2014 | Dec. 31, 2012 | |
Time-Based Stock Awards [Member] | |||||||||||||
Performance Based Awards [Abstract] | |||||||||||||
Exercise price of options granted (in dollars per share) | $ 0 | $ 0 | $ 0 | ||||||||||
Exercised (in shares) | 715,000 | 994,000 | |||||||||||
Restricted Stock Units [Member] | |||||||||||||
Performance Based Awards [Abstract] | |||||||||||||
Unrecognized stock-based compensation expense | $ 27,900,000 | $ 27,900,000 | |||||||||||
Granted (in shares) | 113,000 | 3,543,000 | 0 | ||||||||||
Shares vested during the period (in shares) | 4,674,000 | 4,566,000 | 1,060,000 | 4,674,000 | 1,109,000 | ||||||||
Performance-Based Awards [Member] | |||||||||||||
Performance Based Awards [Abstract] | |||||||||||||
Stock awards granted (in shares) | 154,000 | 0 | 0 | ||||||||||
Granted (in shares) | 73,000 | ||||||||||||
Stock Options forfeited (in shares) | (8,000) | (30,000) | 0 | ||||||||||
Recognized stock-based compensation expense | $ 784,000 | $ 425,000 | |||||||||||
Intrinsic value | $ 1,500,000 | $ 1,500,000 | |||||||||||
Outstanding, vested as of end of period (in shares) | 122,000 | 122,000 | |||||||||||
Remaining contractual life | 6 years 2 months 12 days | ||||||||||||
Shares vested during the period (in shares) | 444,000 | 444,000 | 243,000 | ||||||||||
Vested (in shares) | 0 | 0 | |||||||||||
Forfeited (in shares) | (37,000) | (88,000) | |||||||||||
Exercised (in shares) | (40,000) | (32,000) | |||||||||||
Performance-Based Awards [Roll Forward] | |||||||||||||
Performance-based outstanding at beginning of period (in shares) | 313,000 | 358,000 | 368,000 | 368,000 | |||||||||
Granted (in shares) | 154,000 | 0 | 0 | ||||||||||
Exercised (in shares) | (15,000) | (15,000) | (10,000) | ||||||||||
Forfeited or expired (in shares) | (8,000) | (30,000) | 0 | ||||||||||
Performance-based outstanding at end of period (in shares) | 444,000 | 313,000 | 358,000 | 444,000 | 368,000 | ||||||||
Performance Based Aawards, Weighted Average Exercise Price [Roll Forward] | |||||||||||||
Performance-based outstanding at beginning of period (in dollars per share) | $ 8.36 | $ 8.29 | $ 8.12 | $ 8.12 | |||||||||
Granted (in dollars per share) | 8.83 | 0 | 0 | ||||||||||
Exercised (in dollars per share) | 5.56 | 5.17 | 1.98 | ||||||||||
Forfeited or expired (in dollars per share) | 4.66 | 9.15 | 0 | ||||||||||
Performance-based outstanding at end of period (in dollars per share) | $ 8.69 | $ 8.36 | $ 8.29 | $ 8.69 | $ 8.12 | ||||||||
Performance-Based Awards [Member] | Executive Officer [Member] | |||||||||||||
Performance Based Awards [Abstract] | |||||||||||||
Stock awards granted (in shares) | 65,000 | ||||||||||||
Granted (in shares) | 105,000 | ||||||||||||
Performance-Based Awards [Roll Forward] | |||||||||||||
Granted (in shares) | 65,000 | ||||||||||||
Performance-Based Awards [Member] | Employees [Member] | |||||||||||||
Performance Based Awards [Abstract] | |||||||||||||
Granted (in shares) | 208,740 | ||||||||||||
Performance-Based Awards [Member] | Former Officer [Member] | |||||||||||||
Performance Based Awards [Abstract] | |||||||||||||
Recognized stock-based compensation expense | $ 779,000 | ||||||||||||
June 2015 Award [Member] | Restricted Stock Units [Member] | |||||||||||||
Performance Based Awards [Abstract] | |||||||||||||
Unrecognized stock-based compensation expense | $ 24,000,000 | 24,000,000 | |||||||||||
PN Incentive Program [Member] | Performance-Based Awards [Member] | |||||||||||||
Performance Based Awards [Abstract] | |||||||||||||
Stock awards granted (in shares) | 281,433 | ||||||||||||
Exercise price of options granted (in dollars per share) | $ 10.82 | $ 14.45 | |||||||||||
Term of awards | 10 years | ||||||||||||
Percentage of the options granted and vested | 75.00% | 25.00% | |||||||||||
Percentage of stock options and RSUs to be vested upon the acceptance of the filing of a new drug application | 50.00% | ||||||||||||
Percentage of the stock options and RSUs to be vested upon first cycle of NDA approval | 50.00% | ||||||||||||
Performance-Based Awards [Roll Forward] | |||||||||||||
Granted (in shares) | 281,433 | ||||||||||||
PN Incentive Program [Member] | Performance-Based Awards [Member] | Executive Officer [Member] | |||||||||||||
Performance Based Awards [Abstract] | |||||||||||||
Stock awards granted (in shares) | 11,700 | 20,000 | |||||||||||
Performance-Based Awards [Roll Forward] | |||||||||||||
Granted (in shares) | 11,700 | 20,000 | |||||||||||
PA Incentive Program [Member] | Performance-Based Awards [Member] | |||||||||||||
Performance Based Awards [Abstract] | |||||||||||||
Unrecognized stock-based compensation expense | $ 2,000 | $ 2,000 | |||||||||||
Term of awards | 10 years | ||||||||||||
Percentage of stock options and RSUs to be vested upon the acceptance of the filing of a new drug application | 33.33% | ||||||||||||
Percentage of the stock options and RSUs to be vested upon first cycle of NDA approval | 33.33% | ||||||||||||
Percentage of the stock options and RSUs to be vested if first cycle of NDA not approved by December 31 2012 | 16.50% | ||||||||||||
Percentage of the stock options and RSUs to be vested upon execution of a significant partnering transaction | 33.33% | ||||||||||||
Percentage of RSU's to be vested upon approval of U.S. Food and Drug Administration | 50.00% | ||||||||||||
Percentage of RSUs to be vested upon commercial readiness | 50.00% | ||||||||||||
Stock Options forfeited (in shares) | 177,818 | 132,883 | |||||||||||
Performance-Based Awards [Roll Forward] | |||||||||||||
Forfeited or expired (in shares) | 177,818 | 132,883 | |||||||||||
PA Incentive Program [Member] | Performance-Based Awards [Member] | Executive Officer [Member] | |||||||||||||
Performance Based Awards [Abstract] | |||||||||||||
Stock awards granted (in shares) | 453,960 | ||||||||||||
Performance-Based Awards [Roll Forward] | |||||||||||||
Granted (in shares) | 453,960 |
Summary of Significant Accoun21
Summary of Significant Accounting Policies, Net Loss Per Share (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Net Income (Loss) Per Share [Abstract] | ||||
Basic weighted average shares outstanding (in shares) | 32,732,686 | 31,589,192 | 32,476,358 | 31,118,572 |
Effect of dilutive employee and director awards (in shares) | 0 | 1,360,587 | 0 | 1,495,479 |
Diluted weighted-average shares outstanding and assumed conversions (in shares) | 32,732,686 | 32,949,779 | 32,476,358 | 32,614,051 |
Summary of Significant Accoun22
Summary of Significant Accounting Policies, Common Stock Reserved for Future Issuance (Details) - shares | 12 Months Ended | |
Dec. 31, 2013 | Sep. 30, 2015 | |
Summary of Significant Accounting Policies [Abstract] | ||
Increase in shares authorized shares for grant (in shares) | 416,971 | |
Common stock reserved for future issuance [Abstract] | ||
Common shares available for grant under stock option plans (in shares) | 2,163,703 | |
Common shares issuable pursuant to options and restricted stock units granted under equity compensations plans (in shares) | 6,709,036 | |
Rights Plan shares issuable as Series A Junior Participating Preferred Stock (in shares) | 90,000 | |
Total Reserved | 8,962,739 |
Summary of Significant Accoun23
Summary of Significant Accounting Policies, Leases (Details) | Jul. 15, 2015USD ($) | Sep. 30, 2015USD ($)ft² |
Leases [Abstract] | ||
Office space (in square feet) | ft² | 17,009 | |
Additional lease term extension | 5 years 7 months | |
Lease extension notice period | 7 months | |
Lease extension option available | 3 years | |
Increase in operating leases future minimum payments | $ 2,700,000 | |
Deferred rent balance | $ (3,400) | |
Increase in deferred rent | $ 52,000 |
Summary of Significant Accoun24
Summary of Significant Accounting Policies, Contingencies (Details) $ in Millions | 9 Months Ended |
Sep. 30, 2015USD ($) | |
Contingencies [Abstract] | |
Legal fees | $ 18.2 |