Document_and_Entity_Informatio
Document and Entity Information (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Feb. 24, 2015 | Jun. 30, 2014 | |
Document and Entity Information [Abstract] | |||
Entity Registrant Name | POZEN INC /NC | ||
Entity Central Index Key | 1059790 | ||
Current Fiscal Year End Date | -19 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Accelerated Filer | ||
Entity Public Float | $204,875,000 | ||
Entity Common Stock, Shares Outstanding | 32,246,397 | ||
Document Fiscal Year Focus | 2014 | ||
Document Fiscal Period Focus | FY | ||
Document Type | 10-K | ||
Amendment Flag | FALSE | ||
Document Period End Date | 31-Dec-14 |
Balance_Sheets
Balance Sheets (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
Current assets: | ||
Cash and cash equivalents | $40,582,415 | $32,827,732 |
Investments in warrants | 2,678,773 | 0 |
Accounts receivable | 5,629,209 | 1,673,000 |
Prepaid expenses and other current assets | 583,061 | 794,665 |
Total current assets | 49,473,458 | 35,295,397 |
Property and equipment, net of accumulated depreciation | 27,382 | 38,979 |
Noncurrent deferred tax asset | 952,900 | 0 |
Total assets | 50,453,740 | 35,334,376 |
Current liabilities: | ||
Accounts payable | 606,948 | 1,500,671 |
Accrued compensation | 1,899,456 | 3,132,468 |
Accrued expenses | 253,624 | 1,655,212 |
Deferred revenue | 0 | 11,257,300 |
Total net deferred income taxes, current | 952,900 | 0 |
Total current liabilities | 3,712,928 | 17,545,651 |
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; 32,221,397 and 30,677,437 shares issued and outstanding at December 31, 2014 and December 31, 2013, respectively | 32,221 | 30,677 |
Additional paid-in capital | 143,613,024 | 134,337,213 |
Accumulated deficit | -96,904,433 | -116,579,165 |
Total stockholders' equity | 46,740,812 | 17,788,725 |
Total liabilities and stockholders' equity | $50,453,740 | $35,334,376 |
Balance_Sheets_Parenthetical
Balance Sheets (Parenthetical) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
Preferred stock, par value (in dollars per share) | $0.00 | $0.00 |
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) | $0.00 | $0.00 |
Common stock, shares authorized (in shares) | 90,000,000 | 90,000,000 |
Common stock, shares issued (in shares) | 32,221,397 | 30,677,437 |
Common stock, shares outstanding (in shares) | 32,221,397 | 30,677,437 |
Series A Junior Participating Preferred Stock [Member] | ||
Preferred stock, par value (in dollars per share) | $0.00 | $0.00 |
Preferred stock, shares authorized (in shares) | 90,000 | 90,000 |
Statements_of_Comprehensive_In
Statements of Comprehensive Income (Loss) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Revenue: | |||
Royalty and licensing revenue | $32,394,232 | $10,322,000 | $5,349,000 |
Operating expenses: | |||
Sales, general and administrative | 10,078,771 | 17,160,810 | 19,024,164 |
Research and development | 5,739,848 | 9,945,049 | 11,866,554 |
Total operating expenses | 15,818,619 | 27,105,859 | 30,890,718 |
Interest and other income | 3,099,119 | 75,560 | 258,697 |
Net income (loss) attributable to common stockholders | 19,674,732 | -16,708,299 | -25,283,021 |
Change in unrealized gains/(loss) on marketable Securities | 0 | 3,253 | 14,388 |
Comprehensive income (loss) | $19,674,732 | ($16,705,046) | ($25,268,633) |
Basic net income (loss) per common share (in dollars per share) | $0.63 | ($0.55) | ($0.84) |
Shares used in computing basic net (loss) income per common share (in shares) | 31,359,867 | 30,449,721 | 30,091,985 |
Diluted net income (loss) per common share (in dollars per share) | $0.60 | ($0.55) | ($0.84) |
Shares used in computing diluted net income (loss) per common share (in shares) | 32,810,587 | 30,449,721 | 30,091,985 |
Statements_of_Stockholders_Equ
Statements of Stockholders' Equity (USD $) | Common Stock [Member] | Additional Paid-In Capital [Member] | Accumulated Other Comprehensive Income [Member] | Accumulated Deficit [Member] | Total |
Balance at Dec. 31, 2011 | $29,975 | $180,073,755 | ($17,641) | ($74,587,845) | $105,498,244 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Exercise of common stock options | 253 | 1,306,106 | 0 | 0 | 1,306,359 |
Payments related to net settlement of stock awards | 0 | -188,528 | 0 | 0 | -188,528 |
Issuance of common stock upon vesting of restricted stock | 94 | -94 | 0 | 0 | 0 |
Stock-based compensation | 0 | 2,729,920 | 0 | 0 | 2,729,920 |
Net income (loss) | 0 | 0 | 0 | -25,283,021 | -25,283,021 |
Other comprehensive income | 0 | 0 | 14,388 | 0 | 14,388 |
Balance at Dec. 31, 2012 | 30,322 | 183,921,159 | -3,253 | -99,870,866 | 84,077,362 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Exercise of common stock options | 151 | 661,823 | 0 | 0 | 661,974 |
Payments related to net settlement of stock awards | 0 | -522,439 | 0 | 0 | -522,439 |
Issuance of common stock upon vesting of restricted stock | 204 | -204 | 0 | 0 | 0 |
Distribution to shareholders | 0 | -53,685,512 | 0 | 0 | -53,685,512 |
Stock-based compensation | 0 | 3,962,386 | 0 | 0 | 3,962,386 |
Net income (loss) | 0 | 0 | 0 | -16,708,299 | -16,708,299 |
Other comprehensive income | 0 | 0 | 3,253 | 0 | 3,253 |
Balance at Dec. 31, 2013 | 30,677 | 134,337,213 | 0 | -116,579,165 | 17,788,725 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Exercise of common stock options | 1,484 | 7,587,445 | 0 | 0 | 7,588,929 |
Payments related to net settlement of stock awards | 0 | -192,536 | 0 | 0 | -192,536 |
Issuance of common stock upon vesting of restricted stock | 60 | -60 | 0 | 0 | 0 |
Distribution to shareholders | 0 | 0 | 0 | 0 | 0 |
Stock-based compensation | 0 | 1,880,962 | 0 | 0 | 1,880,962 |
Net income (loss) | 0 | 0 | 0 | 19,674,732 | 19,674,732 |
Other comprehensive income | 0 | 0 | 0 | 0 | 0 |
Balance at Dec. 31, 2014 | $32,221 | $143,613,024 | $0 | ($96,904,433) | $46,740,812 |
Statements_of_Cash_Flows
Statements of Cash Flows (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Operating Activities | |||
Net income (loss) | $19,674,732 | ($16,708,299) | ($25,283,021) |
Adjustments to reconcile net (loss) income to net cash provided by (used in) operating activities: | |||
Depreciation | 18,933 | 29,413 | 45,251 |
Loss on disposal of fixed assets | 0 | 5,205 | 1,535 |
Bond amortization income | 0 | 63,389 | 1,520,071 |
Gain on investment in warrants | -2,678,773 | 0 | 0 |
Noncash compensation expense | 1,880,962 | 3,962,386 | 2,729,920 |
Changes in operating assets and liabilities: | |||
Accounts receivable | -3,956,209 | -321,000 | -222,000 |
Prepaid expenses and other current assets | 211,604 | 63,758 | -158,097 |
Accounts payable and other accrued expenses | -3,528,323 | 1,026,201 | -4,782,946 |
Deferred revenue | -11,257,300 | 11,000,000 | 0 |
Net cash provided by (used in) operating activities | 365,626 | -878,947 | -26,149,287 |
Investing activities | |||
Purchase of equipment | -7,336 | -1,652 | -15,821 |
Purchase of investments | 0 | 0 | -35,922,138 |
Sale and maturities of investments | 0 | 18,838,000 | 24,395,000 |
Net cash (used in) provided by investing activities | -7,336 | 18,836,348 | -11,542,959 |
Financing activities | |||
Proceeds from issuance of common stock | 7,588,929 | 661,974 | 1,306,359 |
Distribution to shareholders | 0 | -53,685,512 | 0 |
Payments related to net settlement of stock-based awards | -192,536 | -522,439 | -188,528 |
Net cash provided by (used in) financing activities | 7,396,393 | -53,545,977 | 1,117,831 |
Net (increase) decrease in cash and cash equivalents | 7,754,683 | -35,588,576 | -36,574,415 |
Cash and cash equivalents at beginning of year | 32,827,732 | 68,416,308 | 104,990,723 |
Cash and cash equivalents at end of year | $40,582,415 | $32,827,732 | $68,416,308 |
Significant_Accounting_Policie
Significant Accounting Policies | 12 Months Ended | ||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||
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 PA product candidates which contain a combination of a proton pump inhibitor and enteric coated aspirin in a single tablet through the clinical development and pre-commercialization stage and our chief commercial officer was responsible for developing the commercialization strategy for these products and conducting all the required pre-commercialization activities. On September 3, 2013, we entered into an exclusive license agreement with sanofi-aventis U.S. LLC, or Sanofi US, for the commercialization of POZEN’s 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 81/40 and 325/40 (“PA” or “YOSPRALA”), including PA8140 and PA32540. On November 29, 2014, we executed a termination agreement with Sanofi US terminating the license agreement for PA. As of the termination date, all licenses granted to Sanofi US were terminated and all rights to the products licensed to Sanofi US under the agreement reverted to us. The termination agreement further provides for the transfer of specified commercial know-how developed by Sanofi US relating to the PA products to us and allows us, and any future collaborators, to use this know-how to commercialize the products. We are currently evaluating all strategic options available to us now that we have full ownership of the PA products. In light of the warning letter sent to our active ingredient supplier and of the time requirements necessary to complete an assessment of its strategic options, and to properly prepare the market for the launch of our YOSPRALA product candidates, we believe the products will be available for commercialization in 2016. | |||||||||||||||||
With respect to future products we may develop, we have decided that we will no longer commit substantial resources to further drug development without a partner who agrees to pay the full cost of that development. Consistent with this model, we have reduced our R&D staff and other costs and expenses as our PA development program activities wind down and intend to continue to reduce staff that is no longer required to support our then current business activities. Our board of directors and management team continue to explore potential ways to return value to our stockholders. On November 21, 2013, our Board of Directors declared a special cash distribution of $1.75 per share to all stockholders of record as of the close of business on December 11, 2013, with a payment date of December 30, 2013. This distribution represented a surplus of corporate cash and is accounted for as a return of capital to stockholders. We are committed to return as much cash to our stockholders as is prudent and may consider other cash distributions in the future. | |||||||||||||||||
Use of Estimates | |||||||||||||||||
The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts in the financial statements and accompanying notes. Actual results could differ from the estimates and assumptions used. | |||||||||||||||||
Revenue Recognition | |||||||||||||||||
Revenue for the fiscal years ended December 31, 2014, 2013 and 2012 consisted of the following royalty revenue and other licensing revenue: | |||||||||||||||||
For the year ended December 31, | |||||||||||||||||
2014 | 2013 | 2012 | |||||||||||||||
Royalty Revenue | $ | 21,136,932 | $ | 6,322,000 | $ | 4,849,000 | |||||||||||
Other licensing revenue | 11,257,300 | 4,000,000 | 500,000 | ||||||||||||||
Total licensing revenue | $ | 32,394,232 | $ | 10,322,000 | $ | 5,349,000 | |||||||||||
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® (naproxen and esomeprazole magnesium) delayed release tablets royalty revenue has been recognized when earned, as will any other future royalty revenues. For VIMOVO or those future arrangements where royalties are reasonably estimable, the Company recognizes revenue based on estimates of royalties earned during the applicable period and reflects in future revenue any differences between the estimated and actual royalties. These estimates are based upon information reported to the Company by its collaboration partners. During the fiscal years ended December 31, 2014, December 31, 2013, and December 31, 2012 the Company recognized $21.1 million, $6.3 million, and $4.8 million, respectively, for VIMOVO royalty revenue. | |||||||||||||||||
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 its PA products, 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 US terminating the license. As of the termination date, all licenses granted to Sanofi US were terminated and all rights to the products licensed to Sanofi US under the agreement reverted to us. The Company received an upfront payment of $15.0 million which is included within the license revenue in the accompanying statements of comprehensive income (loss). The revenue for the fiscal years ended December 31, 2014 and December 31, 2013 was $11.0 million and $4.0 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 and is included in other licensing revenue for the fiscal year ended December 31, 2014. | |||||||||||||||||
Cash, Cash Equivalents, Investments and Concentration of Credit Risk | |||||||||||||||||
Cash is invested in open-ended money market mutual funds, interest-bearing investment-grade debt securities and insured bank deposits. Cash is restricted to the extent of a $42,000 letter of credit in compliance with the terms of the Company’s office lease. The Company considers all highly liquid investments with maturities of 90 days or less when purchased to be cash equivalents. | |||||||||||||||||
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. Approximately 55% of the Company’s cash and cash equivalents are held in fully insured bank deposits and approximately 45% by money market mutual fund managers. | |||||||||||||||||
In connection with its acquisition of all rights, title and interest to develop, commercialize and sell Treximet® (sumatriptan / naproxen sodium) from GlaxoSmithKline (“GSK”), Pernix Therapeutics Holdings, Inc. (“Pernix”) issued the Company a warrant to purchase 500,000 shares of Pernix common stock at an exercise price of $4.28 (the closing price of Pernix common stock as listed on the NASDAQ Global Market on May 13, 2014). The common stock underlying the warrants will be registered by Pernix with the Securities and Exchange Commission and the warrant is exercisable from August 20, 2014, the closing date of the acquisition, until February 28, 2018. We are valuing the warrant using the Black-Sholes option valuation model. | |||||||||||||||||
The warrant also provides for cashless exercise whereby the holder may elect to receive the number of shares of Pernix common stock equal to the number of shares being exercised multiplied by the fair market value of one share of Pernix common stock, less $4.28 (the exercise price) divided by the fair market value of one share of Pernix common stock. Assuming a cashless exercise at December 31, 2014, this would have resulted in 272,098 shares of Pernix common stock valued at $2.6 million. Because the warrant has not been registered by Pernix with the Securities and Exchange Commission, the Company cannot sell or transfer the warrant in reliance upon Rule 144 until after November 13, 2014 when the Company meets certain holding requirements. In November 2014 Pernix submitted a filing to register the underlying shares with the Securities and Exchange Commission but as of December 31, 2014 this had not been completed and, therefore, upon exercise of the warrant the Company is restricted from transferring or selling these shares until such time as such filing is declared effective or an exemption from registration is otherwise met. | |||||||||||||||||
The following table sets forth our financial instruments carried at fair value as of December 31, 2014 and December 31, 2013: | |||||||||||||||||
Financial Instruments | |||||||||||||||||
Carried at Fair Value | |||||||||||||||||
December 31, | December 31, | ||||||||||||||||
2014 | 2013 | ||||||||||||||||
Assets: | |||||||||||||||||
Cash and cash equivalents | $ | 40,582,415 | $ | 32,827,732 | |||||||||||||
Investments in Pernix warrants | 2,678,773 | — | |||||||||||||||
Total cash and investments | $ | 43,261,188 | $ | 32,827,732 | |||||||||||||
Fair Value Measurements | |||||||||||||||||
Financial instruments consist of cash and cash equivalents, short-term investments, accounts receivable and accounts payable. The carrying values of these amounts, other than the investment in warrants, approximate the fair value due to their short-term nature. | |||||||||||||||||
A part of its acquisition of Treximet® (sumatriptan / naproxen sodium) from GlaxoSmithKline (GSK), Pernix Therapeutics Holdings, Inc. (Pernix) granted POZEN a warrant to purchase 500,000 shares of Pernix common stock at an exercise price of $4.28. The common stock underlying the warrants was registered by Pernix with the Securities and Exchange Commission and is exercisable from August 20, 2014, the closing date of the acquisition, until February 28, 2018. The warrant is valued at $2,678,773 using Black-Sholes valuation model discounted for the warrant’s lack of marketability and liquidity. | |||||||||||||||||
Short-term investments gains consisted of the investment in warrants valuation of $2,740,800 on August 20, 2014, with a mark to market adjustment of ($62,027) at December 31, 2014 and a net December 31, 2014 short-term gain of $2,678,773. | |||||||||||||||||
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 December 31, 2014, 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 December 31, 2014. | |||||||||||||||||
The following table sets forth our financial instruments carried at fair value within the fair value hierarchy and using the lowest level of input as of December 31, 2014: | |||||||||||||||||
Financial Instruments | |||||||||||||||||
Carried at Fair Value | |||||||||||||||||
Quoted prices | Significant | Significant | Total | ||||||||||||||
in active | other | unobservable | |||||||||||||||
Markets | observable | inputs | |||||||||||||||
for identical | inputs | (Level 3) | |||||||||||||||
items | (Level 2) | ||||||||||||||||
(Level 1) | |||||||||||||||||
Assets: | |||||||||||||||||
Cash and cash equivalents | $ | 40,582,415 | $ | — | $ | — | $ | 40,582,415 | |||||||||
Investment in warrants | — | 2,678,773 | — | 2,678,773 | |||||||||||||
Total cash and investments | $ | 40,582,415 | $ | 2,678,773 | $ | — | $ | 43,261,188 | |||||||||
The following table sets forth our financial instruments carried at FV within the ASC 820 hierarchy and using the lowest level of input as of December 31, 2013: | |||||||||||||||||
Financial Instruments | |||||||||||||||||
Carried at Fair Value | |||||||||||||||||
Quoted prices | Significant | Significant | |||||||||||||||
in active | other | other | |||||||||||||||
markets | observable | unobservable | |||||||||||||||
for identical | inputs | inputs | |||||||||||||||
items | |||||||||||||||||
(Level 1) | (Level 2) | (Level 3) | Total | ||||||||||||||
Cash and cash equivalents | $ | 32,827,732 | $ | — | $ | — | $ | 32,827,732 | |||||||||
Short-term investments | — | — | — | — | |||||||||||||
Total | $ | 32,827,732 | $ | — | $ | — | $ | 32,827,732 | |||||||||
The Company targets investment principally in Level 1 and Level 2 cash equivalents and financial instruments and records them at FV. The Company expects that the carrying values of cash equivalents will approximate FV because of their short maturities. | |||||||||||||||||
Equipment | |||||||||||||||||
Equipment consists primarily of computer hardware and software and furniture and fixtures and is recorded at cost. Depreciation is computed using an accelerated method over the estimated useful lives of the assets ranging from five to seven years. Accumulated depreciation at December 31, 2014 and 2013 totaled $0.7 million. | |||||||||||||||||
Research and Development Costs, Including Clinical Trial Expenses | |||||||||||||||||
Research and development costs are charged to operations as incurred. The Company has included in research and development expenses the personnel costs associated with research and development activities and costs associated with pharmaceutical development, clinical trials, toxicology activities, and regulatory matters. | |||||||||||||||||
Interest and Other Income | |||||||||||||||||
Interest and bond amortization income was $43,100 and $138,900 for the fiscal years ended December 31, 2014 and 2013, respectively. Other income also included short-term investments gains consisting of the investment in warrants with an initial valuation of $2,740, 800 on August 20, 2014, with a mark to market adjustment of ($62,027) at December 31, 2014 and a net of $377,269 related to the disgorgement of short-swing profits arising from trades by a POZEN shareholder under Section 16(b) of the Securities and Exchange Act of 1934. | |||||||||||||||||
Taxes | |||||||||||||||||
Income taxes are computed using the asset and liability approach, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the Company’s financial statements or tax returns. In estimating future tax consequences, the Company generally considers all expected future events other than enactment of changes in tax law or rates. If it is more likely than not that some or all of a deferred tax asset will not be realized, the Company records a valuation allowance. | |||||||||||||||||
Net Income (Loss) Per Share | |||||||||||||||||
Basic and diluted net income or loss per common share amounts have been computed using the weighted-average number of shares of common stock outstanding for the fiscal year ended December 31, 2014 and 2013. During the fiscal years ended December 31, 2014 and 2013, the Company had potential common stock equivalents related to its outstanding stock options. These potential common stock equivalents were not included, if the effect would have been antidilutive. The Company has excluded the impact of any shares which might be issued under the Rights Plan, detailed below, from the earnings per share calculation because the Rights are not exercisable since the specified contingent future event has not occurred. | |||||||||||||||||
Reconciliation of denominators for basic and diluted earnings per share computations: | |||||||||||||||||
Years ended December 31, | |||||||||||||||||
2014 | 2013 | 2012 | |||||||||||||||
Basic weighted average shares outstanding | 31,359,867 | 30,449,721 | 30,091,985 | ||||||||||||||
Effect of dilutive employee and director awards | 1,450,720 | — | — | ||||||||||||||
Diluted weighted-average shares outstanding and assumed conversions | 32,810,587 | 30,449,721 | 30,091,985 | ||||||||||||||
Patent Costs | |||||||||||||||||
The Company expenses patent costs, including legal expenses, in the period in which they are incurred. Patent expenses are included in general and administrative expenses in the Company’s Statements of Comprehensive Income (Loss). | |||||||||||||||||
Stock-Based Compensation | |||||||||||||||||
Stock-based compensation cost is estimated at the grant date based on the fair value of the award and is recognized as expense over the requisite service period of the award. The fair value of restricted stock awards is determined by reference to the fair market value of our common stock on the date of grant. We use the Black-Scholes model to value service condition and performance condition option awards. For awards with only service conditions and graded-vesting features, we recognize compensation cost on a straight-line basis over the requisite service period. For awards with performance conditions granted we recognize compensation cost over the expected period to achieve the performance conditions, provided achievement of the performance conditions are deemed probable. | |||||||||||||||||
Contingencies | |||||||||||||||||
We, AstraZeneca and Horizon are engaged in Paragraph IV litigation with several generic pharmaceutical companies with respect to patents listed in the Orange Book with respect to VIMOVO currently pending in the United States District Court for the District of New Jersey which is described on page [17] of this Form 10-K. | |||||||||||||||||
On March 14, 2011, we and AstraZeneca received a Paragraph IV Notice Letter from Dr. Reddy’s 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 in 2023. The ‘907 patent is assigned to Pozen and listed with respect to VIMOVO in the Orange Book. On September 19, 2011, Dr. Reddy’s amended its ANDA to include a Paragraph IV certification against the '504 patent, the '085 patent, the '872 patent, the '070 patent, and the '466 patent, which are assigned to AstraZeneca or its affiliates and listed in in the Orange Book, with respect to VIMOVO. The patents listed in the Orange Book which are owned by AstraZeneca or its affiliates expire at various times between 2014 and 2018. AstraZeneca has advised us that it has elected to exercise its first right to prosecute the infringement suit against Dr. Reddy’s. Accordingly, we and AstraZeneca filed suit against Dr. Reddy’s on April 21, 2011 in the United States District Court for the District of New Jersey, asserting only the ‘907 patent against Dr. Reddy’s. An amended complaint was filed on October 28, 2011 to include the AstraZeneca patents. On December 19, 2012, the District Court conducted a pre-trial “Markman” hearing to determine claim construction. On May 1, 2012, 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 actions 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, 2015. Expert discovery is ongoing and set to close May 21, 2015. In view of the upcoming 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 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 the Pozen and the ‘504 patent, the '085 patent, the '872 patent, the '070 patent, the '466 patent and, 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 504 patent, 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. 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 AB received Paragraph IV Notice Letter from 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 unclear 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, we and AstraZeneca filed an Opposition to Anchen’s Motion to Dismiss. On June 11, 2014, the Court granted Anchen’s Motion and dismissed the case against them. | |||||||||||||||||
On November 20, 2012 we and AstraZeneca AB received a Paragraph IV Notice Letter from Dr. Reddy’s, informing us that Dr. Reddy’s had filed a second 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 Pozen and the 504 patent, the '085 patent, the '872 patent, the '070 patent, the '466 patent and, 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. Dr. Reddy’s second 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 Dr. Reddy’s on its second ANDA filing and, accordingly, we and AstraZeneca filed suit against Dr. Reddy’s on January 4, 2013, in the United States District Court for the District of New Jersey. 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 June 28, 2013 we and AstraZeneca filed a Motion for Summary Judgment relating to the second ANDA filing asserting that U.S. Patent No. 6,926,907 is not invalid. On August 12, 2013, DRL filed an opposition to the Motion for Summary Judgment. On March 28, 2014, the District Court denied the Motion. On October 11, 2013, DRL filed a Motion for Summary Judgment asserting that the product which is the subject matter of its second ANDA does not infringe the ‘907 patent. On November 4, 2013, POZEN and AstraZeneca filed a Motion for an Order Denying DRL's Motion for Summary Judgment Pursuant to Rule 56(d) and an Opposition to DRL’s Motion. On May 29, 2014, the Court issued an order denying DRL’s Motion. This case was consolidated with the originally filed Dr. Reddy’s case and 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, 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 ‘424 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. The case is currently consolidated for discovery and pretrial purposes with the first filed Dr. Reddy’s case. | |||||||||||||||||
On May 16, 2013, POZEN and AstraZeneca AB received a Paragraph IV Notice Letter from 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 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 has advised us that it has 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 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 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 has advised us that it has 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 DRL, 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 DRL, Lupin, Watson and Mylan or, in the alternative, to consolidate the actions involving the ‘285 patent with the existing consolidated action. DRL, 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 Horizon’s 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 VIMIVO 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 and February 2, 2014, the Court granted Horizon’s motions. | |||||||||||||||||
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 $17.5 million in legal fees through the fiscal year ended December 31, 2014. 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. | |||||||||||||||||
New Accounting Pronouncements | |||||||||||||||||
Revenue from Contracts with Customers | |||||||||||||||||
In May 2014, the FASB issued new accounting rules related to revenue recognition for contracts with customers requiring revenue recognition based on the transfer of promised goods or services to customers in an amount that reflects consideration the Company expects to be entitled to in exchange for goods or services. The new rules supersede prior revenue recognition requirements and most industry-specific accounting guidance. The new rules will be effective for the Company in the first quarter of 2017 with either full retrospective or modified retrospective application required. The Company does not expect the adoption of the new accounting rules to have a material impact on the Company’s financial condition, results of operations or cash flows. |
License_Agreements
License Agreements | 12 Months Ended | |
Dec. 31, 2014 | ||
License Agreements [Abstract] | ||
License Agreements | 2 | License Agreements |
We have entered into and may continue to enter into collaborations with established pharmaceutical or pharmaceutical services companies to develop, commercialize and/or manufacture our product candidates. Our existing collaborations are described below. | ||
GlaxoSmithKline (GSK) | ||
In June 2003, we signed an agreement with GSK for the development and commercialization of proprietary combinations of a triptan (5-HT1B/1D agonist) and a long-acting NSAID. The combinations covered by the agreement are among the combinations of MT 400. Under the terms of the agreement, GSK has exclusive rights in the U.S. to commercialize all combinations which combine GSK’s triptans, including Imitrex® (sumatriptan succinate) or Amerge® (naratriptan hydrochloride), with a long-acting NSAID. We were responsible for development of the first combination product, while GSK provided formulation development and manufacturing. Pursuant to the terms of the agreement, we received $25.0 million in initial payments from GSK following termination of the waiting period under the Hart-Scott-Rodino notification program and the issuance of a specified patent. In May 2004, we received a $15.0 million milestone payment as a result of our commencement of Phase 3 clinical trial activities. In October 2005, we received a $20.0 million milestone payment upon the FDA’s acceptance for review of the NDA for Treximet, the trade name for the product. On April 26, 2008, we received, from GSK, $20.0 million in milestone payments which were associated with the approval of, and GSK’s intent to commercialize, Treximet. In addition, GSK will pay us two sales performance milestones totaling $80.0 million if certain sales thresholds are achieved. Up to an additional $10.0 million per product is payable upon achievement of milestones relating to other products. GSK will pay us royalties on all net sales of marketed products until at least the expiration of the last to expire issued applicable patent (October 2, 2025) based upon the scheduled expiration of currently issued patents. GSK may reduce, but not eliminate, the royalty payable to us if generic competitors attain a pre-determined share of the market for the combination product, or if GSK owes a royalty to one or more third parties for rights it licenses from such third parties to commercialize the product. The agreement terminates on the date of expiration of all royalty obligations unless earlier terminated by either party for a material breach or by GSK at any time upon ninety (90) days’ written notice to us for any reason or no reason. Among the contract breaches that would entitle us to terminate the agreement is GSK’s determination not to further develop or to launch the combination product under certain circumstances. GSK has the right, but not the obligation, to bring, at its own expense, an action for infringement of certain patents by third parties. If GSK does not bring any such action within a certain time frame, we have the right, at our own expense, to bring the appropriate action. With regard to certain other patent infringements, we have the sole right to bring an action against the infringing third party. Each party generally has the duty to indemnify the other for damages arising from breaches of each party’s representations, warranties and obligations under the agreement, as well as for gross negligence or intentional misconduct. We also have a duty to indemnify GSK for damages arising from our development and manufacture of MT 400 prior to the effective date of the agreement, and each party must indemnify the other for damages arising from the development and manufacture of any combination product after the effective date. | ||
On November 23, 2011, we entered into the Purchase Agreement, with CII, pursuant to which we sold, and CII purchased, our right to receive future royalty payments arising from U.S. sales of MT 400, including Treximet. | ||
On May 13, 2014, we, GSK, CII and Pernix, entered into certain agreements in connection with GSK’s divestiture of all of its rights, title and interest to develop, commercialize and sell Treximet® in the U.S. to Pernix. Upon the closing of the divestiture on August 20, 2014, GSK assigned the Treximet Agreement to Pernix. Immediately following the closing of the divestiture, Amendment No. 1 between us and Pernix became effective. Amendment No. 1, among other things, amends the royalty provisions of the Agreement to provide for a guaranteed quarterly minimum royalty of $4 million for the calendar quarters commencing on January 1, 2015 and ending on March 31, 2018 and requires that Pernix continue certain of GSK’s ongoing development activities and to undertake certain new activities, for which we will provide reasonable assistance. Amendment No. 1 also eliminates restrictions in the Agreement on our right to develop and commercialize certain dosage forms of sumatriptan/naproxen combinations outside of the United States and permits POZEN to seek approval for these combinations on the basis of the approved NDA for Treximet. Pernix has also granted us a warrant to purchase 500,000 shares of Pernix common stock at an exercise price equal to$4.28, the closing price of Pernix common stock as reported on the NASDAQ Global Market on May 13, 2014. The common stock underlying the warrants will be registered by Pernix with the Securities and Exchange Commission and will be exercisable from the August 20, 2014, the closing date of the divestiture until February 28, 2018. If the Divestiture is not consummated, the warrants will be null and void. Because the warrant has not been registered by Pernix with the Securities and Exchange Commission, the Company cannot sell or transfer the warrant in reliance upon Rule 144 until after November 13, 2014 when the Company meets certain holding requirements. Lastly, we, GSK, Pernix and CII executed a letter agreement whereby we expressly consented to the assignment by GSK and the assumption by Pernix of the Treximet Agreement. On July 30, the parties entered into Amendment No. 2 to the Treximet Agreement which will permit Pernix’s Irish affiliate to which Pernix assigned its rights to further assign the Agreement without our prior written consent as collateral security for the benefit of the lenders which financed the acquisition. Amendment No. 2 became effective upon the closing of the divestiture on August 20, 2014. | ||
AstraZeneca AB (AstraZeneca) | ||
In August 2006, we entered into a collaboration and license agreement dated as of August 1, 2006 and effective September 7, 2006 with AstraZeneca, a Swedish corporation, regarding the development and commercialization of proprietary fixed dose combinations of the PPI esomeprazole magnesium with the NSAID naproxen, in a single tablet for the management of pain and inflammation associated with conditions such as osteoarthritis and rheumatoid arthritis in patients who are at risk for developing NSAID associated gastric ulcers, as amended, the “Original Agreement”. Under the terms of the Original Agreement, we granted to AstraZeneca an exclusive, fee-bearing license, in all countries of the world except Japan, under our patents and know-how relating to combinations of gastroprotective agents and NSAIDs (other than aspirin and its derivatives). Pursuant to the terms of the agreement, we received an upfront license fee of $40.0 million from AstraZeneca following termination of the waiting period under the Hart-Scott-Rodino notification program. | ||
We retained responsibility for the development and filing of the NDA for the product in the U.S. AstraZeneca is responsible for all development activities outside the U.S., as well as for all manufacturing, marketing, sales and distribution activities worldwide. We agreed to bear all expenses related to certain specified U.S. development activities. All other development expenses, including all manufacturing-related expenses, will be paid by AstraZeneca. The agreement established joint committees with representation of both us and AstraZeneca to manage the development and commercialization of the product. The committees operate by consensus, but if consensus cannot be reached, we generally will have the deciding vote with respect to development activities required for marketing approval of the product in the U.S. and AstraZeneca generally will have the deciding vote with respect to any other matters. | ||
In September 2007, we agreed with AstraZeneca to amend the Original Agreement effective as of September 6, 2007. Under the terms of the amendment, AstraZeneca has agreed to pay us up to $345.0 million, in the aggregate, in milestone payments upon the achievement of certain development, regulatory and sales events. In September 2007 we received a $10.0 million payment upon execution of the amendment and a $20.0 million payment in recognition of the achievement of the primary endpoints for the PN400-104 study, a study which compared acid suppression of different doses of VIMOVO (formerly PN 400), and achievement of the interim results of the PN200-301 study, a six month comparative trial of PN 200 as compared to EC naproxen in patients requiring chronic NSAID therapy, meeting mutually agreed success criteria. In May 2010, we received a $20.0 million payment for the NDA approval of VIMOVO. We also received an additional $25.0 million milestone in December 2010 when VIMOVO received approval (including pricing and reimbursement approval) in a major ex-U.S. market and up to $260.0 million will be paid as sales performance milestones if certain aggregate sales thresholds are achieved. | ||
The amendment also revised the royalty rates we were to have received under the Original Agreement. Prior to the effective date of the amendment, under the terms of the Original Agreement, we were to receive a royalty based on annual net sales by AstraZeneca, its affiliates or sublicensees during the royalty term. The royalty rate varied based on the level of annual net sales of products made by AstraZeneca, its affiliates and sublicensees, ranging from the mid-single digits to the mid-teens. Under the amendment, we receive a flat, low double digit royalty rate during the royalty term on annual net sales of products made by AstraZeneca, its affiliates and sublicensees, in the U.S. and royalties ranging from the mid-single digits to the high-teens on annual net sales of products made by AstraZeneca, its affiliates and sublicensees outside of the U.S. The amendment also revised the rate of reduction to the royalty rate based upon loss of market share due to generic competition inside and outside of the U.S. to account for the new royalty structure. Our right to receive royalties from AstraZeneca for the sale of such products under the collaboration and license agreement, as amended, expires on a country-by-country basis upon the later of (a) expiration of the last-to-expire of certain patent rights relating to such products in that country, and (b) ten years after the first commercial sale of such products in such country. | ||
We further amended the Original Agreement effective October 1, 2008 to shorten the timing of AstraZeneca’s reimbursement obligation for certain development expenses incurred by us under the agreement and to update the description of the target product profile studies (as defined in the agreement) for VIMOVO. | ||
On December 31, 2014 we accrued $5.6 million of VIMOVO royalty revenue, $4.3 million related to U.S. sales and $1.3 million related to ROW sales. The agreement, unless earlier terminated, will expire upon the payment of all applicable royalties for the products commercialized under the agreement. Either party has the right to terminate the agreement by notice in writing to the other party upon or after any material breach of the agreement by the other party, if the other party has not cured the breach within 90 days after written notice to cure has been given, with certain exceptions. The parties also can terminate the agreement for cause under certain defined conditions. In addition, AstraZeneca can terminate the agreement, at any time, at will, for any reason or no reason, in its entirety or with respect to countries outside the U.S., upon 90 days’ notice. If terminated at will, AstraZeneca will owe us a specified termination payment or, if termination occurs after the product is launched, AstraZeneca may, at its option, under and subject to the satisfaction of conditions specified in the agreement, elect to transfer the product and all rights to us. | ||
On May 3, 2013, AstraZeneca informed us that, after a strategic business review, it had decided to cease promotion and sampling of VIMOVO by the end of the third quarter of 2013 in certain countries, including the U.S. and all countries in Europe, other than Spain and Portugal, which have pre-existing contractual relationships with third parties. We understand that AstraZeneca will instead now focus on those countries where the product has shown growth and which AstraZeneca believes have the greatest potential for future growth. | ||
On September 16, 2013, we and AstraZeneca entered into another amendment to the Original Agreement which made clarifications to certain intellectual property provisions of the Original Agreement to clarify that AstraZeneca’s rights under those provisions do not extend to products which contain acetyl salicylic acid. On September 16, 2013, we and AstraZeneca also executed a letter agreement whereby we agreed that in the event that AstraZeneca divested its rights and obligations to market VIMOVO in the United States to a third party, AstraZeneca would be relieved of its obligations under the Original Agreement with respect to the United States as of the effective date of such divestiture, including its obligation under the Original Agreement to guarantee the performance of such assignee and/or sublicensee. | ||
On November 18, 2013, AstraZeneca and Horizon entered into certain agreements in connection with AstraZeneca’s divestiture of all of its rights, title and interest to develop, commercialize and sell VIMOVO in the United States to Horizon. In connection with this divestiture, on November 18, 2013 we and AstraZeneca entered into an Amended and Restated Collaboration and License Agreement for the United States, the “U.S. Agreement,” and an Amended and Restated License and Collaboration Agreement for Outside the United States, the “ROW Agreement,” which agreements collectively amend and restate the Original Agreement. AstraZeneca has assigned the U.S. Agreement to Horizon in connection with the Divestiture with our consent. | ||
We and Horizon also entered into Amendment No. 1 to the U.S. Agreement which, among other things, amends the royalty provisions of the U.S. Agreement to provide for a guaranteed annual minimum royalty amount of $5 million in calendar year 2014, and a guaranteed annual minimum royalty amount of $7.5 million each calendar year thereafter, provided that the patents owned by us which cover VIMOVO are in effect and no generic forms of VIMOVO are in the marketplace. Amendment No. 1 also provides that Horizon has assumed AstraZeneca’s right to lead the on-going Paragraph IV litigation relating to VIMIVO currently pending in the United States District Court for the District of New Jersey and will assume all patent-related defense costs relating to such litigation, including reimbursement up to specified amounts of the cost of any counsel retained by us, amends certain time periods for Horizon’s delivery of quarterly sales reports to POZEN, and provides for quarterly update calls between the parties to discuss VIMOVO’s performance and Horizon’s commercialization efforts. | ||
Further, the Company, AstraZeneca and Horizon executed a letter agreement whereby POZEN expressly consented to the assignment by AstraZeneca and the assumption by Horizon of the U.S. Agreement. In addition, the letter agreement establishes a process for AstraZeneca and Horizon to determine if sales milestones set forth in the Original Agreement are achieved on a global basis and other clarifications and modifications required as a result of incorporating the provisions of the Original Agreement into the U.S. Agreement and the ROW Agreement or as otherwise agreed by the parties. | ||
sanof-aventis U.S. LLC | ||
On September 3, 2013, we entered into an exclusive license and collaboration agreement with Sanofi US for .the commercialization of products containing a combination of immediate release omeprazole and 325 mg or less of delayed release aspirin, including PA32540 and PA8140 in the United States. On November 29, 2014, we executed a termination agreement with Sanofi US terminating the license agreement for PA. As of the termination date, all licenses granted to Sanofi US were terminated and all rights to the products licensed to Sanofi US under the agreement reverted to us. The termination agreement further provides for the transfer of specified commercial know-how developed by Sanofi US relating to the PA products to us and allows us, and any future collaborators, to use this know-how to commercialize the products. | ||
Cilag GmbH International (Cilag) | ||
On March 21, 2011, we entered into a license agreement with Cilag, a division of Johnson & Johnson, for the exclusive development and commercialization of MT 400 in Brazil, Colombia, Ecuador and Peru. In December 2014 we received an executed, mutual termination from Cilag. There was no dispute between the parties regarding the license agreement and, at our request, for a period of two years after termination, Cilag has agreed to negotiate in good faith commercially reasonable terms of a supply agreement whereby Cilag would supply us or our licensees, with MT400 for a period equal to the shorter of (i) two (2) years; or (ii) until we establish an alternative supplier. We recognized approximately $257,300 in licensing revenue in the fourth quarter of as a result of this termination that had previously been recorded as deferred revenue. | ||
Patheon Pharmaceuticals Inc. (Patheon) | ||
On December 19, 2011, we entered into a Manufacturing Services Agreement, or the Supply Agreement, and a related Capital Expenditure and Equipment Agreement, or the Capital Agreement, relating to the manufacture of PA32450. Under the terms of the Supply Agreement, Patheon has agreed to manufacture, and we have agreed to purchase, a specified percentage of the Company’s requirements of the PA32540 for sale in the United States. The term of the Supply Agreement extends until December 31st of the fourth year after the we notify Patheon to begin manufacturing services under the Supply Agreement, or the Initial Term, and will automatically renew thereafter for periods of two years, unless terminated by either party upon eighteen months’ written notice prior to the expiration of the Initial Term or twelve months’ written notice prior to the expiration of any renewal term. In addition to usual and customary termination rights which allow each party to terminate the Supply Agreement for material, uncured breaches by the other party, we can terminate the Agreement upon thirty (30) days’ prior written notice if a governmental or regulatory authority takes any action or raises any objection that prevents us from importing, exporting, purchasing or selling PA32540 or if it is determined that the formulation or sale of PA32540 infringes any patent rights or other intellectual property rights of a third party. We can also terminate the Supply Agreement upon twenty-four (24) months’ prior written notice if we license, sell, assign or otherwise transfer any rights to commercialize PA32540 in the Territory to a third party. The Supply Agreement contains general and customary commercial supply terms and conditions, as well as establishing pricing for bulk product and different configurations of packaged product, which pricing will be adjusted annually as set forth in the Supply Agreement. Under the terms of the Capital Agreement, we will be responsible for the cost of purchasing certain equipment specific to the manufacture of PA32540, the cost of which, based on current volume projections, is expected to be less than $150,000. If additional equipment and facility modifications are required to meet our volume demands for PA32540, we may be required to contribute to the cost of such additional equipment and facility modifications, up to a maximum of approximately $2.5 million in the aggregate. | ||
The Supply Agreement and Capital Agreement were amended on July 10, 2013. The First Amendment to the Manufacturing and Services Agreement (the “Amendment to the Supply Agreement”) expressly incorporates the Company’s PA8140 product candidate into the Supply Agreement. The Amendment to the Supply Agreement also clarifies that the manufacturing services contemplated by the Supply Agreement include the manufacture of validation batches, but the placing of an order for such validation batches will not trigger the Commencement Date of the Initial Term (each as defined in the Supply Agreement), updates pricing for the Company’s PA32540 product candidate and a incorporates a new pricing schedule for PA8140, as well as other conforming changes to the Supply Agreement. The First Amendment to the Capital Expenditure and Equipment Agreement (the “Amendment to the Capital Agreement”), replaces the existing Schedule A of the Capital Agreement, which lists dedicated and non-dedicated capital equipment and facility modifications to be funded in whole or in part by the Company, with a new updated schedule which reflects the parties’ current assumptions regarding the need for and timing of capital equipment expenditures based upon Patheon’s current and anticipated production capacity and current volume projections for thePA32540 and PA8140. Under the terms of the Capital Agreement, the Company was previously required to contribute to the cost of such additional capital equipment and facility modifications, up to a maximum of approximately $2.5 million in the aggregate. Pursuant to the terms of the Amendment to the Capital Agreement, the parties have agreed to reduce the amount of such maximum expenditure to approximately $1.2 million dollars in light of the revised capacity and volume assumptions. |
Stockholders_Equity
Stockholders' Equity | 12 Months Ended | ||||
Dec. 31, 2014 | |||||
Stockholders' Equity [Abstract] | |||||
Stockholders' Equity | 3 | Stockholders’ Equity | |||
Shares Reserved for Future Issuance | |||||
In January 2005, the Company approved a stockholder rights plan (the “Rights Plan”), pursuant to which the Company entered into a Rights Agreement dated January 12, 2005 with StockTrans, Inc., as Rights Agent, and the Company declared a dividend of a right to acquire one preferred share purchase right (a “Right”) for each outstanding share of the Company’s Common Stock, $0.001 par value per share, to stockholders of record at the close of business on January 28, 2005. Generally, the Rights only are triggered and become exercisable if a person or group acquires beneficial ownership of 15 percent or more of the Company’s common stock or announces a tender offer for 15 percent or more of the Company’s common stock. The Rights Plan is similar to plans adopted by many other publicly-traded companies. The effect of the Rights Plan is to discourage any potential acquirer from triggering the Rights without first convincing POZEN’s Board of Directors that the proposed acquisition is fair to, and in the best interest of, the shareholders and the Company. The provisions of the Plan will substantially dilute the equity and voting interest of any potential acquirer unless the Board of Directors determines that the proposed acquisition is in the best interest of the shareholders. In connection with the Plan, the Company designated 90,000 shares of its authorized Preferred Stock as Series A Junior Participating Preferred Stock. Each Right, if and when exercisable, will entitle the registered holder to purchase from the Company one one-thousandth of a share of Series A Junior Participating Preferred Stock, $0.001 par value per share, at a purchase price of $80.00 for each one one-thousandth of a share, subject to adjustment. Each holder of a Right (except for the Acquiring Person (as defined in the Rights Plan), whose Rights will be null and void upon such event) shall thereafter have the right to receive, upon exercise, that number of shares of Common Stock of the Company (or, in certain circumstances, cash, property or other securities of the Company) which equals the exercise price of the Right divided by 50% of the current market price (as defined in the Rights Agreement) per share of Common Stock at the date of the occurrence of such event. The Rights can be terminated by POZEN’s Board of Directors and are subject to optional redemption by the Company at $0.001 per Right. The Rights Plan has a 10-year term and contains provisions requiring a periodic review and evaluation by the Board of Directors | |||||
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 December 31, 2014, shares of our common stock reserved for future issuance are as follows: | |||||
Common shares available for grant under stock option plans | 2,474,430 | ||||
Common shares issuable pursuant to options and restricted stock units granted under equity compensations plans | 3,817,920 | ||||
Rights Plan shares issuable as Series A Junior Participating Preferred Stock | 90,000 | ||||
Total Reserved | 6,382,350 |
Accrued_Expenses
Accrued Expenses | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Accrued Expenses [Abstract] | |||||||||
Accrued Expenses | 4 | Accrued Expenses | |||||||
Accrued expenses consist of the following at December 31: | |||||||||
2014 | 2013 | ||||||||
Research and development costs | $ | 55,227 | $ | 1,025,995 | |||||
Other | 198,397 | 629,217 | |||||||
$ | 253,624 | $ | 1,655,212 |
Income_Taxes
Income Taxes | 12 Months Ended | ||||||||||||
Dec. 31, 2014 | |||||||||||||
Income Taxes [Abstract] | |||||||||||||
Income Taxes | 5 | Income Taxes | |||||||||||
The Company did not record a provision for income taxes during the years ended December 31, 2014, 2013 and 2012. | |||||||||||||
Deferred income taxes reflect the net tax effects of temporary differences between the carrying amount of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s deferred tax assets are as follows at December 31: | |||||||||||||
($ in thousands) | 2014 | 2013 | |||||||||||
Current | |||||||||||||
Deferred income tax assets | |||||||||||||
Other current assets | $ | 662 | $ | 1,080 | |||||||||
Less valuation allowance | (647 | ) | (1,080 | ) | |||||||||
Total net deferred income tax assets, current | $ | 15 | $ | - | |||||||||
Deferred income tax liabilities | |||||||||||||
Investment in warrants | (968 | ) | - | ||||||||||
Total net deferred income taxes, current | $ | (953 | ) | $ | - | ||||||||
Non-current | |||||||||||||
Deferred income tax assets (liabilities) | |||||||||||||
Tax loss carryforwards | $ | 20,840 | $ | 25,909 | |||||||||
Research and development credits | 13,987 | 13,992 | |||||||||||
Equity compensation and other | 6,683 | 7,549 | |||||||||||
Total gross deferred income taxes, non-current | 41,510 | 47,450 | |||||||||||
Less valuation allowance | (40,557 | ) | (47,450 | ) | |||||||||
Total net deferred income taxes, non-current | $ | 953 | $ | - | |||||||||
Total net deferred income taxes | $ | - | $ | - | |||||||||
At December 31, 2014 and 2013, the Company had federal net operating loss carryforwards of approximately $53 million and $66.8 million respectively, state net economic loss carryforwards of approximately $78 million and $82.9 million respectively, and research and development credit carryforwards of approximately $14 million and $14 million, respectively. The federal and state net operating loss carryforwards begin to expire in 2028 and 2015, respectively, and the research and development credit carryforwards begin to expire in 2018. For financial reporting purposes, a valuation allowance has been recognized to offset the deferred tax assets related to the carryforwards, based on the Company's assessment regarding the realizability of these deferred tax assets in future periods. Of the total decrease in valuation allowance of $7.3 million, a decrease of $7.3 million was allocable to current operating activities. The utilization of the 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. The recognized tax benefit related to net operating loss carryforwards was approximately $4.8M, $0, and $0 for the years ended December 31, 2014, 2013 and 2012, respectively. | |||||||||||||
The research and development credit, which had previously expired on December 31, 2011, was reinstated as part of the American Taxpayer Relief Act of 2012 enacted on January 2, 2013. This legislation retroactively reinstated and extended the credit from the previous expiration date through December 31, 2013. As a result, the Company adjusted its deferred tax assets in 2013 for both the 2013 and 2012 research and development credits, which resulted in an increase to the deferred tax assets and a corresponding increase to the valuation allowance of $0.02 million and $0.11 million, respectively. | |||||||||||||
On July 23, 2013, North Carolina enacted House Bill 998, which reduced the corporate income tax rate from 6.9% in 2013 to 6% in 2014 and to 5% in 2015. As a result of the new enacted tax rate, the Company adjusted its deferred tax assets in 2013 by applying the lower rate, which resulted in a decrease to the deferred tax assets and a corresponding decrease to the valuation allowance of approximately $0.03 million. | |||||||||||||
The actual income tax benefit (expense) for the years ended December 31, 2014, 2013 and 2012, differed from the amounts computed by applying the U.S. federal tax rate of 35% to income (loss) before taxes as a result of the following: | |||||||||||||
($ in thousands) | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
(Loss) income before income tax | $ | 19,675 | $ | (16,708 | ) | $ | (25,283 | ) | |||||
Federal tax rate | 35 | % | 35 | % | 35 | % | |||||||
Federal income tax provision at statutory rate | 6,886 | (5,848 | ) | (8,849 | ) | ||||||||
State tax provision | 224 | (215 | ) | (343 | ) | ||||||||
7,110 | (6,063 | ) | (9,192 | ) | |||||||||
Decrease (increase) in income tax benefit resulting from: | |||||||||||||
Research and development credits | 4 | 66 | — | ||||||||||
Non-deductible expenses and other | 177 | 302 | 409 | ||||||||||
Change in state tax rate | 35 | 966 | — | ||||||||||
Change in valuation allowance | (7,326 | ) | 4,729 | 8,783 | |||||||||
Income tax expense | $ | — | $ | — | $ | — | |||||||
The Company had gross unrecognized tax benefits of approximately $0.5 million as of January 1, 2014. As of December 31, 2014, the total gross unrecognized tax benefits were approximately $0.5 million and of this total, none would reduce the Company’s effective tax rate if recognized. The Company does not anticipate a significant change in total unrecognized tax benefits or the Company’s effective tax rate due to the settlement of audits or the expiration of statutes of limitations within the next 12 months. | |||||||||||||
The Company’s policy for recording interest and penalties associated with tax audits is to record them as a component of provision for income taxes. The Company has not recorded any interest or penalty since adoption of FASB ASC 740-10. | |||||||||||||
The Company has analyzed its filing positions in all significant federal, state and foreign jurisdictions where it is required to file income tax returns, as well as open tax years in these jurisdictions. With few exceptions, the Company is no longer subject to US Federal and state and local tax examinations by tax authorities for years before 2011, although carryforward attributes that were generated prior to 2011 may still be adjusted upon examination by the Internal Revenue Service (IRS) if they either have been or will be used in a future period. No income tax returns are currently under examination by taxing authorities. | |||||||||||||
Rollforward of gross unrecognized tax positions: | |||||||||||||
($ in thousands) | |||||||||||||
Gross tax liability at January 1, 2014 | $ | 538 | |||||||||||
Additions/Decreases for tax positions of prior years | (1 | ) | |||||||||||
Additions/Decreases for tax positions of the current year | — | ||||||||||||
Gross tax liability at December 31, 2014 | $ | 537 |
Equity_Compensation_Plans
Equity Compensation Plans | 12 Months Ended | ||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||
Equity Compensation Plans [Abstract] | |||||||||||||||||
Equity Compensation Plans | 6 | Equity Compensation 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. | |||||||||||||||||
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 a spinoff or the Company’s payment of an extraordinary dividend or distribution, the 2010 Plan requires that an equitable adjustment be made to all outstanding grants to preclude dilution of rights and benefits under the plan. Consequently, as a result of the 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. | |||||||||||||||||
Our Statements of Comprehensive Income (Loss) for the fiscal years ended December 31, 2014, 2013 and 2012 include the following stock-based compensation expense: | |||||||||||||||||
Years ended December 31, | |||||||||||||||||
2014 | 2013 | 2012 | |||||||||||||||
Research and development | $ | 295,631 | $ | 765,526 | $ | 461,118 | |||||||||||
Sales, general and administrative | 1,585,331 | 3,196,860 | 2,268,802 | ||||||||||||||
Total expense | $ | 1,880,962 | $ | 3,962,386 | $ | 2,729,920 | |||||||||||
Unrecognized stock-based compensation expense, including time-based options, performance-based options and restricted stock awards, expected to be recognized over an estimated weighted-average amortization period of 2.0 years, was $4.1 million at December 31, 2014. | |||||||||||||||||
Time-Based Stock Awards | |||||||||||||||||
No new time-based awards were granted during the year ended December 31, 2014. Previously, the fair value of each time-based award was estimated on the date of grant using the Black-Scholes option valuation model, which used the assumptions described below. Our weighted-average assumptions used in the Black-Scholes valuation model for equity awards with time-based vesting provisions granted for the years ended December 31, 2013 and 2012 are shown in the following table: | |||||||||||||||||
2013 | 2012 | ||||||||||||||||
Expected volatility | 63.70% | 68.0–72.3% | |||||||||||||||
Expected dividends | 0% | 0% | |||||||||||||||
Expected terms | 6.0 Years | 6.0 Years | |||||||||||||||
Risk-free interest rate | 1.25% | 0.91–1.33% | |||||||||||||||
Weighted average grant date fair value | $ | 5.35 | $ | 4.87 | |||||||||||||
For the years ended December 31, 2013 and 2012, 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. For the years ended December 31, 2013 and 2012, the expected term was based upon average historical terms to exercise. The risk-free interest rate was based on six-year U.S. Treasury securities. The pre-vesting forfeiture rates used of the years ended December 31, 2013 and 2012 were based on historical rates. We adjust the estimated forfeiture rate based upon actual experience. | |||||||||||||||||
A summary of the time-based stock awards as of December 31, 2014, and changes during the year ended December 31, 2014, are as follows: | |||||||||||||||||
Time-Based Stock Awards | Underlying | Weighted- | Average | Aggregate | |||||||||||||
Shares | Average | Remaining | Intrinsic | ||||||||||||||
(000s) | Exercise | Contractual | Value | ||||||||||||||
Price | Term | (000s) | |||||||||||||||
(years) | |||||||||||||||||
Outstanding at December 31, 2013 | 4,315 | $ | 6.82 | 4.3 | $ | 8,553 | |||||||||||
Granted | ― | ― | |||||||||||||||
Exercised | (1,479 | ) | 5.34 | ||||||||||||||
Forfeited or expired | (495 | ) | 8.52 | ||||||||||||||
Outstanding at December 31, 2014 | 2,341 | 7.39 | 4.1 | $ | 4,382 | ||||||||||||
Exercisable at December 31, 2014 | 1,865 | $ | 8.29 | 3.4 | $ | 2,402 | |||||||||||
Vested or expected to vest at December 31, 2014 | 2,270 | $ | 7.39 | 4.1 | $ | 4,248 | |||||||||||
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. The exercise price of stock options granted during the years ended December 31, 2014, 2013 and 2012 was equal to the market price of the underlying common stock on the grant date. A total of 1,479,000 stock options were exercised during the year ended December 31, 2014 with an intrinsic value of $4.6 million, a total of 138,562 stock options were exercised during the year ended December 31, 2013 with an intrinsic value of $589,000 and a total of 252,398 stock options were exercised during the year ended December 31, 2012 with an intrinsic value of $304,000. The fair value of shares vested during the years ended December 31, 2014, 2013 and 2012 were $1.1 million, $0.6 million and $0.4 million, respectively. | |||||||||||||||||
A summary of the time-based nonvested awards as of December 31, 2014, and changes during the year ended December 31, 2014, are as follows: | |||||||||||||||||
Underlying | Weighted-Average | ||||||||||||||||
Shares | Exercise Price | ||||||||||||||||
(000s) | |||||||||||||||||
Nonvested outstanding at December 31, 2013 | 760 | $ | 4.06 | ||||||||||||||
Granted | ― | ― | |||||||||||||||
Forfeited or expired | (7 | ) | 3.87 | ||||||||||||||
Vested | (276 | ) | 4.47 | ||||||||||||||
Nonvested outstanding at December 31, 2014 | 477 | $ | 3.85 | ||||||||||||||
Restricted Stock and Restricted Stock Units | |||||||||||||||||
For the years ended December 31, 2014, 2013 and 2012, the Company recognized $1.0 million, $1.2 million and $1.0 million, respectively, in compensation expense related to restricted stock units. | |||||||||||||||||
A summary of the restricted stock awards as of December 31, 2014, and changes during the year ended December 31, 2014, are as follows: | |||||||||||||||||
Underlying | Weighted-Average | ||||||||||||||||
Shares | Exercise Price | ||||||||||||||||
(000s) | |||||||||||||||||
Restricted stock outstanding at December 31, 2013 | 747 | $ | 6.22 | ||||||||||||||
Granted | 450 | 8.32 | |||||||||||||||
Vested and released | (84 | ) | 5.32 | ||||||||||||||
Forfeited or expired | (4 | ) | 5.91 | ||||||||||||||
Restricted stock outstanding at December 31, 2014 | 1,109 | $ | 7.14 | ||||||||||||||
As of December 31, 2014 there was an aggregate $3.8 million of unrecognized compensation expense related to unvested restricted stock units. There were 627,000 unvested restricted stock units outstanding at December 31, 2014, 523,000 unvested restricted stock units outstanding at December 31, 2013, and 430,000 unvested restricted stock units outstanding at December 31, 2012. The total fair value of restricted stock that vested during the years ended December 31, 2014, 2013 and 2012 was $726,000, $863,000and $920,000, 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 immediately preceding 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 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 immediately preceding the date of grant. The underlying stock options and RSUs 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 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 vest 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 vest in accordance with the following schedule: (i) 50% upon receipt of the milestone payment by Sanofi US 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 US upon achievement of commercial readiness (as defined in the Agreement). The entire award was forfeited in 2014 upon the termination of the Sanofi US 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. In 2012, 132,883 options were forfeited in acknowledgement that certain performance goals would not be met under the PA32540 incentive program. | |||||||||||||||||
During the twelve months ended December 31, 2014, in acknowledgement that certain performance goals would not be met under the PA32540 and PA8140 incentive programs and as a result of the forfeitures and accompanying prior expense reversals, there was a net negative expense of $11,000 recorded related to the achievement of vesting criteria for performance-based awards under the PA32540 and PA8140 incentive programs. As of December 31, 2014, there was $6,000 in unrecognized compensation expense related to performance-based awards granted under the PA32540 and PA8140 incentive programs. 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. | |||||||||||||||||
A summary of the performance-based stock awards as of December 31, 2014, and changes during the fiscal year ended December 31, 2014, are as follows: | |||||||||||||||||
Underlying | Weighted-Average | ||||||||||||||||
Shares | Exercise Price | ||||||||||||||||
(000s) | |||||||||||||||||
Performance-based outstanding at December 31, 2013 | 540 | $ | 6.76 | ||||||||||||||
Granted | 73 | 7.89 | |||||||||||||||
Exercised | (46 | ) | 1.99 | ||||||||||||||
Forfeited or expired | (199 | ) | 5.77 | ||||||||||||||
Performance-based outstanding at December 31, 2014 | 368 | $ | 8.12 | ||||||||||||||
The December 31, 2014 amount is expected to be recognized at the time of the grant vesting over the period ending in second quarter 2015. Under the PA32540 and PA8140 incentive programs, there were 139,000 unvested performance-based options outstanding at December 31, 2014. No performance-based awards vested during the twelve months ended December 31, 2014 and December 31, 2012. A total of 231,000 performance-based awards vested during the twelve months ended December 31, 2013. There were 229,000 vested performance-based options outstanding at December 31, 2014. The total value of performance-based awards that vested during the year ended December 31, 2014, 2013 and 2012 was $0.0, $1.0 million and $0, respectively. There were 199,000 awards forfeited during the twelve months ended December 31, 2014, 37,000 awards forfeited during the twelve months ended December 31, 2013, and 204,123 awards forfeited during the year ended December 31, 2012. A total of 46,000 performance-based awards were exercised during the year ended December 31, 2014, 162,000 performance-based awards were exercised during the year ended December 31, 2013 and no performance-based awards were exercised during the years ended December 31, 2012. At December 31, 2014, the performance-based options had an intrinsic value of $1.3 million and a remaining weighted contractual life of 5.2 years. |
Leases
Leases | 12 Months Ended | |
Dec. 31, 2014 | ||
Leases [Abstract] | ||
Leases | 7 | Leases |
The Company leases its office space and certain equipment under cancellable and noncancellable operating lease agreements. Rent expense incurred by the Company was approximately $419,000, $419,000 and $419,000, for the fiscal years ended December 31, 2014, 2013 and 2012, respectively. At December 31, 2014 noncancellable future minimum lease payments for operating leases totaled $0.4 million, all relating to the 2015 lease agreement. | ||
On February 16, 2009, the Company modified certain terms to our existing lease agreement, dated November 21, 2001, relating to approximately 17,009 square feet of office space located at Exchange Office Building, Chapel Hill, North Carolina. Under the terms of the modification, the lease term was extended for an additional 5 years and 7 months, terminating on September 30, 2015. The modification also provides the Company with a reduced notice period of 7 months for renewals of the lease. The Company is also entitled to a 3-year lease extension option available at the end of the term and a first offer right on available space located within the Exchange Office Building property. As a result of entering into the modification, the Company’s noncancellable future minimum lease payments for operating leases increased by approximately $2.7 million over the lease term. The Company is recognizing rent expense on a straight-line basis over the term of the lease which resulted in a deferred rent balance of $62,600 at December 31, 2014. |
Retirement_Savings_Plan
Retirement Savings Plan | 12 Months Ended | |
Dec. 31, 2014 | ||
Retirement Savings Plan [Abstract] | ||
Retirement Savings Plan | 8 | Retirement Savings Plan |
The Company has adopted a defined contribution 401(k) plan (the “Plan”) covering substantially all employees who are at least 21 years of age. Based upon management’s discretion, the Company may elect to make contributions to the Plan. During the fiscal years ended December 31, 2014, 2013 and 2012, the Company made contributions of $141,887 and $191,582 and $224,420 respectively, to the Plan. |
Summary_of_Operations_by_Quart
Summary of Operations by Quarters (Unaudited) | 12 Months Ended | ||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||
Summary of Operations by Quarters (Unaudited) [Abstract] | |||||||||||||||||
Summary of Operations by Quarters (Unaudited) | 9 | Summary of Operations by Quarters (Unaudited) | |||||||||||||||
2014 | |||||||||||||||||
1st Quarter | 2nd Quarter | 3rd Quarter | 4th Quarter | ||||||||||||||
Revenue | |||||||||||||||||
Licensed revenue | $ | 7,548,676 | $ | 7,419,306 | $ | 7,539,741 | $ | 9,886,509 | |||||||||
Total revenue | 7,548,676 | 7,419,306 | 7,539,741 | 9,886,509 | |||||||||||||
Operating expenses | 4,651,396 | 4,426,615 | 3,628,176 | 3,112,431 | |||||||||||||
Income before income tax expense | 2,904,691 | 2,999,457 | 6,752,169 | 7,018,415 | |||||||||||||
Income tax expense | — | — | — | — | |||||||||||||
Net income attributable to common stockholders | $ | 2,904,691 | $ | 2,999,457 | $ | 6,752,169 | $ | 7,018,415 | |||||||||
Basic net income per common share | $ | 0.09 | $ | 0.1 | $ | 0.21 | $ | 0.22 | |||||||||
Diluted net income per common share | $ | 0.09 | $ | 0.09 | $ | 0.2 | $ | 0.21 | |||||||||
Shares used in computing basic net income per common share | 30,743,966 | 31,022,557 | 31,589,192 | 32,083,752 | |||||||||||||
Shares used in computing diluted net income per common share | 32,489,969 | 32,604,123 | 32,949,779 | 33,353,631 | |||||||||||||
Comprehensive income | $ | 2,904,691 | $ | 2,999,457 | $ | 6,752,169 | $ | 7,018,415 | |||||||||
2013 | |||||||||||||||||
1st Quarter | 2nd Quarter | 3rd Quarter | 4th Quarter | ||||||||||||||
Revenue | |||||||||||||||||
Licensed revenue | $ | 1,415,000 | $ | 1,651,000 | $ | 2,583,000 | $ | 4,673,000 | |||||||||
Total revenue | 1,415,000 | 1,651,000 | 2,583,000 | 4,673,000 | |||||||||||||
Operating expenses | 7,217,983 | 5,654,378 | 7,364,190 | 6,869,308 | |||||||||||||
Loss before income tax benefit | (5,777,932 | ) | (3,987,996 | ) | (4,767,193 | ) | (2,175,178 | ) | |||||||||
Income tax expense | — | — | — | — | |||||||||||||
Net loss attributable to common stockholders | $ | (5,777,932 | ) | $ | (3,987,996 | ) | $ | (4,767,193 | ) | $ | (2,175,178 | ) | |||||
Basic and diluted net loss per common share | $ | (0.19 | ) | $ | (0.13 | ) | $ | (0.16 | ) | $ | (0.07 | ) | |||||
Shares used in computing basic and diluted net loss per common share | 30,336,398 | 30,403,670 | 30,476,562 | 30,353,631 | |||||||||||||
Comprehensive Loss | $ | (5,774,679 | ) | $ | (3,987,996 | ) | $ | (4,767,193 | ) | $ | (2,175,178 | ) | |||||
Because of the method used in calculating per share data, the quarterly per share data will not necessarily add to the per share data as computed for the year. |
Significant_Accounting_Policie1
Significant Accounting Policies (Policies) | 12 Months Ended | ||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||
Significant Accounting Policies [Abstract] | |||||||||||||||||
Use of Estimates | Use of Estimates | ||||||||||||||||
The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts in the financial statements and accompanying notes. Actual results could differ from the estimates and assumptions used. | |||||||||||||||||
Revenue Recognition | Revenue Recognition | ||||||||||||||||
Revenue for the fiscal years ended December 31, 2014, 2013 and 2012 consisted of the following royalty revenue and other licensing revenue: | |||||||||||||||||
For the year ended December 31, | |||||||||||||||||
2014 | 2013 | 2012 | |||||||||||||||
Royalty Revenue | $ | 21,136,932 | $ | 6,322,000 | $ | 4,849,000 | |||||||||||
Other licensing revenue | 11,257,300 | 4,000,000 | 500,000 | ||||||||||||||
Total licensing revenue | $ | 32,394,232 | $ | 10,322,000 | $ | 5,349,000 | |||||||||||
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® (naproxen and esomeprazole magnesium) delayed release tablets royalty revenue has been recognized when earned, as will any other future royalty revenues. For VIMOVO or those future arrangements where royalties are reasonably estimable, the Company recognizes revenue based on estimates of royalties earned during the applicable period and reflects in future revenue any differences between the estimated and actual royalties. These estimates are based upon information reported to the Company by its collaboration partners. During the fiscal years ended December 31, 2014, December 31, 2013, and December 31, 2012 the Company recognized $21.1 million, $6.3 million, and $4.8 million, respectively, for VIMOVO royalty revenue. | |||||||||||||||||
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 its PA products, 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 US terminating the license. As of the termination date, all licenses granted to Sanofi US were terminated and all rights to the products licensed to Sanofi US under the agreement reverted to us. The Company received an upfront payment of $15.0 million which is included within the license revenue in the accompanying statements of comprehensive income (loss). The revenue for the fiscal years ended December 31, 2014 and December 31, 2013 was $11.0 million and $4.0 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 and is included in other licensing revenue for the fiscal year ended December 31, 2014. | |||||||||||||||||
Cash, Cash Equivalents, Investments and Concentration of Credit Risk | Cash, Cash Equivalents, Investments and Concentration of Credit Risk | ||||||||||||||||
Cash is invested in open-ended money market mutual funds, interest-bearing investment-grade debt securities and insured bank deposits. Cash is restricted to the extent of a $42,000 letter of credit in compliance with the terms of the Company’s office lease. The Company considers all highly liquid investments with maturities of 90 days or less when purchased to be cash equivalents. | |||||||||||||||||
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. Approximately 55% of the Company’s cash and cash equivalents are held in fully insured bank deposits and approximately 45% by money market mutual fund managers. | |||||||||||||||||
In connection with its acquisition of all rights, title and interest to develop, commercialize and sell Treximet® (sumatriptan / naproxen sodium) from GlaxoSmithKline (“GSK”), Pernix Therapeutics Holdings, Inc. (“Pernix”) issued the Company a warrant to purchase 500,000 shares of Pernix common stock at an exercise price of $4.28 (the closing price of Pernix common stock as listed on the NASDAQ Global Market on May 13, 2014). The common stock underlying the warrants will be registered by Pernix with the Securities and Exchange Commission and the warrant is exercisable from August 20, 2014, the closing date of the acquisition, until February 28, 2018. We are valuing the warrant using the Black-Sholes option valuation model. | |||||||||||||||||
The warrant also provides for cashless exercise whereby the holder may elect to receive the number of shares of Pernix common stock equal to the number of shares being exercised multiplied by the fair market value of one share of Pernix common stock, less $4.28 (the exercise price) divided by the fair market value of one share of Pernix common stock. Assuming a cashless exercise at December 31, 2014, this would have resulted in 272,098 shares of Pernix common stock valued at $2.6 million. Because the warrant has not been registered by Pernix with the Securities and Exchange Commission, the Company cannot sell or transfer the warrant in reliance upon Rule 144 until after November 13, 2014 when the Company meets certain holding requirements. In November 2014 Pernix submitted a filing to register the underlying shares with the Securities and Exchange Commission but as of December 31, 2014 this had not been completed and, therefore, upon exercise of the warrant the Company is restricted from transferring or selling these shares until such time as such filing is declared effective or an exemption from registration is otherwise met. | |||||||||||||||||
The following table sets forth our financial instruments carried at fair value as of December 31, 2014 and December 31, 2013: | |||||||||||||||||
Financial Instruments | |||||||||||||||||
Carried at Fair Value | |||||||||||||||||
December 31, | December 31, | ||||||||||||||||
2014 | 2013 | ||||||||||||||||
Assets: | |||||||||||||||||
Cash and cash equivalents | $ | 40,582,415 | $ | 32,827,732 | |||||||||||||
Investments in Pernix warrants | 2,678,773 | — | |||||||||||||||
Total cash and investments | $ | 43,261,188 | $ | 32,827,732 | |||||||||||||
Fair Value Measurement | Fair Value Measurements | ||||||||||||||||
Financial instruments consist of cash and cash equivalents, short-term investments, accounts receivable and accounts payable. The carrying values of these amounts, other than the investment in warrants, approximate the fair value due to their short-term nature. | |||||||||||||||||
A part of its acquisition of Treximet® (sumatriptan / naproxen sodium) from GlaxoSmithKline (GSK), Pernix Therapeutics Holdings, Inc. (Pernix) granted POZEN a warrant to purchase 500,000 shares of Pernix common stock at an exercise price of $4.28. The common stock underlying the warrants was registered by Pernix with the Securities and Exchange Commission and is exercisable from August 20, 2014, the closing date of the acquisition, until February 28, 2018. The warrant is valued at $2,678,773 using Black-Sholes valuation model discounted for the warrant’s lack of marketability and liquidity. | |||||||||||||||||
Short-term investments gains consisted of the investment in warrants valuation of $2,740,800 on August 20, 2014, with a mark to market adjustment of ($62,027) at December 31, 2014 and a net December 31, 2014 short-term gain of $2,678,773. | |||||||||||||||||
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 December 31, 2014, 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 December 31, 2014. | |||||||||||||||||
The following table sets forth our financial instruments carried at fair value within the fair value hierarchy and using the lowest level of input as of December 31, 2014: | |||||||||||||||||
Financial Instruments | |||||||||||||||||
Carried at Fair Value | |||||||||||||||||
Quoted prices | Significant | Significant | Total | ||||||||||||||
in active | other | unobservable | |||||||||||||||
Markets | observable | inputs | |||||||||||||||
for identical | inputs | (Level 3) | |||||||||||||||
items | (Level 2) | ||||||||||||||||
(Level 1) | |||||||||||||||||
Assets: | |||||||||||||||||
Cash and cash equivalents | $ | 40,582,415 | $ | — | $ | — | $ | 40,582,415 | |||||||||
Investment in warrants | — | 2,678,773 | — | 2,678,773 | |||||||||||||
Total cash and investments | $ | 40,582,415 | $ | 2,678,773 | $ | — | $ | 43,261,188 | |||||||||
The following table sets forth our financial instruments carried at FV within the ASC 820 hierarchy and using the lowest level of input as of December 31, 2013: | |||||||||||||||||
Financial Instruments | |||||||||||||||||
Carried at Fair Value | |||||||||||||||||
Quoted prices | Significant | Significant | |||||||||||||||
in active | other | other | |||||||||||||||
markets | observable | unobservable | |||||||||||||||
for identical | inputs | inputs | |||||||||||||||
items | |||||||||||||||||
(Level 1) | (Level 2) | (Level 3) | Total | ||||||||||||||
Cash and cash equivalents | $ | 32,827,732 | $ | — | $ | — | $ | 32,827,732 | |||||||||
Short-term investments | — | — | — | — | |||||||||||||
Total | $ | 32,827,732 | $ | — | $ | — | $ | 32,827,732 | |||||||||
The Company targets investment principally in Level 1 and Level 2 cash equivalents and financial instruments and records them at FV. The Company expects that the carrying values of cash equivalents will approximate FV because of their short maturities. | |||||||||||||||||
Equipment | Equipment | ||||||||||||||||
Equipment consists primarily of computer hardware and software and furniture and fixtures and is recorded at cost. Depreciation is computed using an accelerated method over the estimated useful lives of the assets ranging from five to seven years. Accumulated depreciation at December 31, 2014 and 2013 totaled $0.7 million. | |||||||||||||||||
Research and Development Costs, Including Clinical Trial Expenses | Research and Development Costs, Including Clinical Trial Expenses | ||||||||||||||||
Research and development costs are charged to operations as incurred. The Company has included in research and development expenses the personnel costs associated with research and development activities and costs associated with pharmaceutical development, clinical trials, toxicology activities, and regulatory matters. | |||||||||||||||||
Interest and Other Income | Interest and Other Income | ||||||||||||||||
Interest and bond amortization income was $43,100 and $138,900 for the fiscal years ended December 31, 2014 and 2013, respectively. Other income also included short-term investments gains consisting of the investment in warrants with an initial valuation of $2,740, 800 on August 20, 2014, with a mark to market adjustment of ($62,027) at December 31, 2014 and a net of $377,269 related to the disgorgement of short-swing profits arising from trades by a POZEN shareholder under Section 16(b) of the Securities and Exchange Act of 1934. | |||||||||||||||||
Taxes | Taxes | ||||||||||||||||
Income taxes are computed using the asset and liability approach, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the Company’s financial statements or tax returns. In estimating future tax consequences, the Company generally considers all expected future events other than enactment of changes in tax law or rates. If it is more likely than not that some or all of a deferred tax asset will not be realized, the Company records a valuation allowance. | |||||||||||||||||
Net Income (Loss) Per Share | Net Income (Loss) Per Share | ||||||||||||||||
Basic and diluted net income or loss per common share amounts have been computed using the weighted-average number of shares of common stock outstanding for the fiscal year ended December 31, 2014 and 2013. During the fiscal years ended December 31, 2014 and 2013, the Company had potential common stock equivalents related to its outstanding stock options. These potential common stock equivalents were not included, if the effect would have been antidilutive. The Company has excluded the impact of any shares which might be issued under the Rights Plan, detailed below, from the earnings per share calculation because the Rights are not exercisable since the specified contingent future event has not occurred. | |||||||||||||||||
Reconciliation of denominators for basic and diluted earnings per share computations: | |||||||||||||||||
Years ended December 31, | |||||||||||||||||
2014 | 2013 | 2012 | |||||||||||||||
Basic weighted average shares outstanding | 31,359,867 | 30,449,721 | 30,091,985 | ||||||||||||||
Effect of dilutive employee and director awards | 1,450,720 | — | — | ||||||||||||||
Diluted weighted-average shares outstanding and assumed conversions | 32,810,587 | 30,449,721 | 30,091,985 | ||||||||||||||
Patent Costs | Patent Costs | ||||||||||||||||
The Company expenses patent costs, including legal expenses, in the period in which they are incurred. Patent expenses are included in general and administrative expenses in the Company’s Statements of Comprehensive Income (Loss). | |||||||||||||||||
Stock-Based Compensation | Stock-Based Compensation | ||||||||||||||||
Stock-based compensation cost is estimated at the grant date based on the fair value of the award and is recognized as expense over the requisite service period of the award. The fair value of restricted stock awards is determined by reference to the fair market value of our common stock on the date of grant. We use the Black-Scholes model to value service condition and performance condition option awards. For awards with only service conditions and graded-vesting features, we recognize compensation cost on a straight-line basis over the requisite service period. For awards with performance conditions granted we recognize compensation cost over the expected period to achieve the performance conditions, provided achievement of the performance conditions are deemed probable. | |||||||||||||||||
Contingencies | Contingencies | ||||||||||||||||
We, AstraZeneca and Horizon are engaged in Paragraph IV litigation with several generic pharmaceutical companies with respect to patents listed in the Orange Book with respect to VIMOVO currently pending in the United States District Court for the District of New Jersey which is described on page [17] of this Form 10-K. | |||||||||||||||||
On March 14, 2011, we and AstraZeneca received a Paragraph IV Notice Letter from Dr. Reddy’s 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 in 2023. The ‘907 patent is assigned to Pozen and listed with respect to VIMOVO in the Orange Book. On September 19, 2011, Dr. Reddy’s amended its ANDA to include a Paragraph IV certification against the '504 patent, the '085 patent, the '872 patent, the '070 patent, and the '466 patent, which are assigned to AstraZeneca or its affiliates and listed in in the Orange Book, with respect to VIMOVO. The patents listed in the Orange Book which are owned by AstraZeneca or its affiliates expire at various times between 2014 and 2018. AstraZeneca has advised us that it has elected to exercise its first right to prosecute the infringement suit against Dr. Reddy’s. Accordingly, we and AstraZeneca filed suit against Dr. Reddy’s on April 21, 2011 in the United States District Court for the District of New Jersey, asserting only the ‘907 patent against Dr. Reddy’s. An amended complaint was filed on October 28, 2011 to include the AstraZeneca patents. On December 19, 2012, the District Court conducted a pre-trial “Markman” hearing to determine claim construction. On May 1, 2012, 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 actions 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, 2015. Expert discovery is ongoing and set to close May 21, 2015. In view of the upcoming 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 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 the Pozen and the ‘504 patent, the '085 patent, the '872 patent, the '070 patent, the '466 patent and, 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 504 patent, 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. 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 AB received Paragraph IV Notice Letter from 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 unclear 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, we and AstraZeneca filed an Opposition to Anchen’s Motion to Dismiss. On June 11, 2014, the Court granted Anchen’s Motion and dismissed the case against them. | |||||||||||||||||
On November 20, 2012 we and AstraZeneca AB received a Paragraph IV Notice Letter from Dr. Reddy’s, informing us that Dr. Reddy’s had filed a second 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 Pozen and the 504 patent, the '085 patent, the '872 patent, the '070 patent, the '466 patent and, 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. Dr. Reddy’s second 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 Dr. Reddy’s on its second ANDA filing and, accordingly, we and AstraZeneca filed suit against Dr. Reddy’s on January 4, 2013, in the United States District Court for the District of New Jersey. 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 June 28, 2013 we and AstraZeneca filed a Motion for Summary Judgment relating to the second ANDA filing asserting that U.S. Patent No. 6,926,907 is not invalid. On August 12, 2013, DRL filed an opposition to the Motion for Summary Judgment. On March 28, 2014, the District Court denied the Motion. On October 11, 2013, DRL filed a Motion for Summary Judgment asserting that the product which is the subject matter of its second ANDA does not infringe the ‘907 patent. On November 4, 2013, POZEN and AstraZeneca filed a Motion for an Order Denying DRL's Motion for Summary Judgment Pursuant to Rule 56(d) and an Opposition to DRL’s Motion. On May 29, 2014, the Court issued an order denying DRL’s Motion. This case was consolidated with the originally filed Dr. Reddy’s case and 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, 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 ‘424 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. The case is currently consolidated for discovery and pretrial purposes with the first filed Dr. Reddy’s case. | |||||||||||||||||
On May 16, 2013, POZEN and AstraZeneca AB received a Paragraph IV Notice Letter from 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 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 has advised us that it has 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 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 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 has advised us that it has 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 DRL, 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 DRL, Lupin, Watson and Mylan or, in the alternative, to consolidate the actions involving the ‘285 patent with the existing consolidated action. DRL, 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 Horizon’s 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 VIMIVO 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 and February 2, 2014, the Court granted Horizon’s motions. | |||||||||||||||||
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 $17.5 million in legal fees through the fiscal year ended December 31, 2014. 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. | |||||||||||||||||
New Accounting Pronouncements | New Accounting Pronouncements | ||||||||||||||||
Revenue from Contracts with Customers | |||||||||||||||||
In May 2014, the FASB issued new accounting rules related to revenue recognition for contracts with customers requiring revenue recognition based on the transfer of promised goods or services to customers in an amount that reflects consideration the Company expects to be entitled to in exchange for goods or services. The new rules supersede prior revenue recognition requirements and most industry-specific accounting guidance. The new rules will be effective for the Company in the first quarter of 2017 with either full retrospective or modified retrospective application required. The Company does not expect the adoption of the new accounting rules to have a material impact on the Company’s financial condition, results of operations or cash flows. |
Significant_Accounting_Policie2
Significant Accounting Policies (Tables) | 12 Months Ended | ||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||
Significant Accounting Policies [Abstract] | |||||||||||||||||
Licensing revenue | Revenue for the fiscal years ended December 31, 2014, 2013 and 2012 consisted of the following royalty revenue and other licensing revenue: | ||||||||||||||||
For the year ended December 31, | |||||||||||||||||
2014 | 2013 | 2012 | |||||||||||||||
Royalty Revenue | $ | 21,136,932 | $ | 6,322,000 | $ | 4,849,000 | |||||||||||
Other licensing revenue | 11,257,300 | 4,000,000 | 500,000 | ||||||||||||||
Total licensing revenue | $ | 32,394,232 | $ | 10,322,000 | $ | 5,349,000 | |||||||||||
Financial Instruments Carried at Fair Value | The following table sets forth our financial instruments carried at fair value within the fair value hierarchy and using the lowest level of input as of December 31, 2014: | ||||||||||||||||
Financial Instruments | |||||||||||||||||
Carried at Fair Value | |||||||||||||||||
Quoted prices | Significant | Significant | Total | ||||||||||||||
in active | other | unobservable | |||||||||||||||
Markets | observable | inputs | |||||||||||||||
for identical | inputs | (Level 3) | |||||||||||||||
items | (Level 2) | ||||||||||||||||
(Level 1) | |||||||||||||||||
Assets: | |||||||||||||||||
Cash and cash equivalents | $ | 40,582,415 | $ | — | $ | — | $ | 40,582,415 | |||||||||
Investment in warrants | — | 2,678,773 | — | 2,678,773 | |||||||||||||
Total cash and investments | $ | 40,582,415 | $ | 2,678,773 | $ | — | $ | 43,261,188 | |||||||||
The following table sets forth our financial instruments carried at FV within the ASC 820 hierarchy and using the lowest level of input as of December 31, 2013: | |||||||||||||||||
Financial Instruments | |||||||||||||||||
Carried at Fair Value | |||||||||||||||||
Quoted prices | Significant | Significant | |||||||||||||||
in active | other | other | |||||||||||||||
markets | observable | unobservable | |||||||||||||||
for identical | inputs | inputs | |||||||||||||||
items | |||||||||||||||||
(Level 1) | (Level 2) | (Level 3) | Total | ||||||||||||||
Cash and cash equivalents | $ | 32,827,732 | $ | — | $ | — | $ | 32,827,732 | |||||||||
Short-term investments | — | — | — | — | |||||||||||||
Total | $ | 32,827,732 | $ | — | $ | — | $ | 32,827,732 | |||||||||
Financial Instruments Within Fair Value Hierarchy | The following table sets forth our financial instruments carried at fair value within the fair value hierarchy and using the lowest level of input as of December 31, 2014: | ||||||||||||||||
Financial Instruments | |||||||||||||||||
Carried at Fair Value | |||||||||||||||||
Quoted prices | Significant | Significant | Total | ||||||||||||||
in active | other | unobservable | |||||||||||||||
Markets | observable | inputs | |||||||||||||||
for identical | inputs | (Level 3) | |||||||||||||||
items | (Level 2) | ||||||||||||||||
(Level 1) | |||||||||||||||||
Assets: | |||||||||||||||||
Cash and cash equivalents | $ | 40,582,415 | $ | — | $ | — | $ | 40,582,415 | |||||||||
Investment in warrants | — | 2,678,773 | — | 2,678,773 | |||||||||||||
Total cash and investments | $ | 40,582,415 | $ | 2,678,773 | $ | — | $ | 43,261,188 | |||||||||
The following table sets forth our financial instruments carried at FV within the ASC 820 hierarchy and using the lowest level of input as of December 31, 2013: | |||||||||||||||||
Financial Instruments | |||||||||||||||||
Carried at Fair Value | |||||||||||||||||
Quoted prices | Significant | Significant | |||||||||||||||
in active | other | other | |||||||||||||||
markets | observable | unobservable | |||||||||||||||
for identical | inputs | inputs | |||||||||||||||
items | |||||||||||||||||
(Level 1) | (Level 2) | (Level 3) | Total | ||||||||||||||
Cash and cash equivalents | $ | 32,827,732 | $ | — | $ | — | $ | 32,827,732 | |||||||||
Short-term investments | — | — | — | — | |||||||||||||
Total | $ | 32,827,732 | $ | — | $ | — | $ | 32,827,732 | |||||||||
Reconciliation of denominators for basic and diluted earnings per share computations | Reconciliation of denominators for basic and diluted earnings per share computations: | ||||||||||||||||
Years ended December 31, | |||||||||||||||||
2014 | 2013 | 2012 | |||||||||||||||
Basic weighted average shares outstanding | 31,359,867 | 30,449,721 | 30,091,985 | ||||||||||||||
Effect of dilutive employee and director awards | 1,450,720 | — | — | ||||||||||||||
Diluted weighted-average shares outstanding and assumed conversions | 32,810,587 | 30,449,721 | 30,091,985 |
Stockholders_Equity_Tables
Stockholders' Equity (Tables) | 12 Months Ended | ||||
Dec. 31, 2014 | |||||
Stockholders' Equity [Abstract] | |||||
Common shares reserved for future issuance | At December 31, 2014, shares of our common stock reserved for future issuance are as follows: | ||||
Common shares available for grant under stock option plans | 2,474,430 | ||||
Common shares issuable pursuant to options and restricted stock units granted under equity compensations plans | 3,817,920 | ||||
Rights Plan shares issuable as Series A Junior Participating Preferred Stock | 90,000 | ||||
Total Reserved | 6,382,350 |
Accrued_Expenses_Tables
Accrued Expenses (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Accrued Expenses [Abstract] | |||||||||
Accrued expenses | Accrued expenses consist of the following at December 31: | ||||||||
2014 | 2013 | ||||||||
Research and development costs | $ | 55,227 | $ | 1,025,995 | |||||
Other | 198,397 | 629,217 | |||||||
$ | 253,624 | $ | 1,655,212 |
Income_Taxes_Tables
Income Taxes (Tables) | 12 Months Ended | ||||||||||||
Dec. 31, 2014 | |||||||||||||
Income Taxes [Abstract] | |||||||||||||
Significant components of the company's deferred tax assets | Significant components of the Company’s deferred tax assets are as follows at December 31: | ||||||||||||
($ in thousands) | 2014 | 2013 | |||||||||||
Current | |||||||||||||
Deferred income tax assets | |||||||||||||
Other current assets | $ | 662 | $ | 1,080 | |||||||||
Less valuation allowance | (647 | ) | (1,080 | ) | |||||||||
Total net deferred income tax assets, current | $ | 15 | $ | - | |||||||||
Deferred income tax liabilities | |||||||||||||
Investment in warrants | (968 | ) | - | ||||||||||
Total net deferred income taxes, current | $ | (953 | ) | $ | - | ||||||||
Non-current | |||||||||||||
Deferred income tax assets (liabilities) | |||||||||||||
Tax loss carryforwards | $ | 20,840 | $ | 25,909 | |||||||||
Research and development credits | 13,987 | 13,992 | |||||||||||
Equity compensation and other | 6,683 | 7,549 | |||||||||||
Total gross deferred income taxes, non-current | 41,510 | 47,450 | |||||||||||
Less valuation allowance | (40,557 | ) | (47,450 | ) | |||||||||
Total net deferred income taxes, non-current | $ | 953 | $ | - | |||||||||
Total net deferred income taxes | $ | - | $ | - | |||||||||
Effective income tax reconciliation | The actual income tax benefit (expense) for the years ended December 31, 2014, 2013 and 2012, differed from the amounts computed by applying the U.S. federal tax rate of 35% to income (loss) before taxes as a result of the following: | ||||||||||||
($ in thousands) | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
(Loss) income before income tax | $ | 19,675 | $ | (16,708 | ) | $ | (25,283 | ) | |||||
Federal tax rate | 35 | % | 35 | % | 35 | % | |||||||
Federal income tax provision at statutory rate | 6,886 | (5,848 | ) | (8,849 | ) | ||||||||
State tax provision | 224 | (215 | ) | (343 | ) | ||||||||
7,110 | (6,063 | ) | (9,192 | ) | |||||||||
Decrease (increase) in income tax benefit resulting from: | |||||||||||||
Research and development credits | 4 | 66 | — | ||||||||||
Non-deductible expenses and other | 177 | 302 | 409 | ||||||||||
Change in state tax rate | 35 | 966 | — | ||||||||||
Change in valuation allowance | (7,326 | ) | 4,729 | 8,783 | |||||||||
Income tax expense | $ | — | $ | — | $ | — | |||||||
Rollforward of gross unrecognized tax positions | Rollforward of gross unrecognized tax positions: | ||||||||||||
($ in thousands) | |||||||||||||
Gross tax liability at January 1, 2014 | $ | 538 | |||||||||||
Additions/Decreases for tax positions of prior years | (1 | ) | |||||||||||
Additions/Decreases for tax positions of the current year | — | ||||||||||||
Gross tax liability at December 31, 2014 | $ | 537 |
Equity_Compensation_Plans_Tabl
Equity Compensation Plans (Tables) | 12 Months Ended | ||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||
Equity Compensation Plans [Abstract] | |||||||||||||||||
Stock-based compensation expense | Our Statements of Comprehensive Income (Loss) for the fiscal years ended December 31, 2014, 2013 and 2012 include the following stock-based compensation expense: | ||||||||||||||||
Years ended December 31, | |||||||||||||||||
2014 | 2013 | 2012 | |||||||||||||||
Research and development | $ | 295,631 | $ | 765,526 | $ | 461,118 | |||||||||||
Sales, general and administrative | 1,585,331 | 3,196,860 | 2,268,802 | ||||||||||||||
Total expense | $ | 1,880,962 | $ | 3,962,386 | $ | 2,729,920 | |||||||||||
Fair value assumptions used in the valuation of equity awards | Our weighted-average assumptions used in the Black-Scholes valuation model for equity awards with time-based vesting provisions granted for the years ended December 31, 2013 and 2012 are shown in the following table: | ||||||||||||||||
2013 | 2012 | ||||||||||||||||
Expected volatility | 63.70% | 68.0–72.3% | |||||||||||||||
Expected dividends | 0% | 0% | |||||||||||||||
Expected terms | 6.0 Years | 6.0 Years | |||||||||||||||
Risk-free interest rate | 1.25% | 0.91–1.33% | |||||||||||||||
Weighted average grant date fair value | $ | 5.35 | $ | 4.87 | |||||||||||||
Summary of time-based stock awards | A summary of the time-based stock awards as of December 31, 2014, and changes during the year ended December 31, 2014, are as follows: | ||||||||||||||||
Time-Based Stock Awards | Underlying | Weighted- | Average | Aggregate | |||||||||||||
Shares | Average | Remaining | Intrinsic | ||||||||||||||
(000s) | Exercise | Contractual | Value | ||||||||||||||
Price | Term | (000s) | |||||||||||||||
(years) | |||||||||||||||||
Outstanding at December 31, 2013 | 4,315 | $ | 6.82 | 4.3 | $ | 8,553 | |||||||||||
Granted | ― | ― | |||||||||||||||
Exercised | (1,479 | ) | 5.34 | ||||||||||||||
Forfeited or expired | (495 | ) | 8.52 | ||||||||||||||
Outstanding at December 31, 2014 | 2,341 | 7.39 | 4.1 | $ | 4,382 | ||||||||||||
Exercisable at December 31, 2014 | 1,865 | $ | 8.29 | 3.4 | $ | 2,402 | |||||||||||
Vested or expected to vest at December 31, 2014 | 2,270 | $ | 7.39 | 4.1 | $ | 4,248 | |||||||||||
Summary of time-based nonvested awards | A summary of the time-based nonvested awards as of December 31, 2014, and changes during the year ended December 31, 2014, are as follows: | ||||||||||||||||
Underlying | Weighted-Average | ||||||||||||||||
Shares | Exercise Price | ||||||||||||||||
(000s) | |||||||||||||||||
Nonvested outstanding at December 31, 2013 | 760 | $ | 4.06 | ||||||||||||||
Granted | ― | ― | |||||||||||||||
Forfeited or expired | (7 | ) | 3.87 | ||||||||||||||
Vested | (276 | ) | 4.47 | ||||||||||||||
Nonvested outstanding at December 31, 2014 | 477 | $ | 3.85 | ||||||||||||||
Summary of restricted stock awards | A summary of the restricted stock awards as of December 31, 2014, and changes during the year ended December 31, 2014, are as follows: | ||||||||||||||||
Underlying | Weighted-Average | ||||||||||||||||
Shares | Exercise Price | ||||||||||||||||
(000s) | |||||||||||||||||
Restricted stock outstanding at December 31, 2013 | 747 | $ | 6.22 | ||||||||||||||
Granted | 450 | 8.32 | |||||||||||||||
Vested and released | (84 | ) | 5.32 | ||||||||||||||
Forfeited or expired | (4 | ) | 5.91 | ||||||||||||||
Restricted stock outstanding at December 31, 2014 | 1,109 | $ | 7.14 | ||||||||||||||
Summary of performance-based stock awards | A summary of the performance-based stock awards as of December 31, 2014, and changes during the fiscal year ended December 31, 2014, are as follows: | ||||||||||||||||
Underlying | Weighted-Average | ||||||||||||||||
Shares | Exercise Price | ||||||||||||||||
(000s) | |||||||||||||||||
Performance-based outstanding at December 31, 2013 | 540 | $ | 6.76 | ||||||||||||||
Granted | 73 | 7.89 | |||||||||||||||
Exercised | (46 | ) | 1.99 | ||||||||||||||
Forfeited or expired | (199 | ) | 5.77 | ||||||||||||||
Performance-based outstanding at December 31, 2014 | 368 | $ | 8.12 |
Summary_of_Operations_by_Quart1
Summary of Operations by Quarters (Unaudited) (Tables) | 12 Months Ended | ||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||
Summary of Operations by Quarters (Unaudited) [Abstract] | |||||||||||||||||
Schedule of quarterly financial information | 2014 | ||||||||||||||||
1st Quarter | 2nd Quarter | 3rd Quarter | 4th Quarter | ||||||||||||||
Revenue | |||||||||||||||||
Licensed revenue | $ | 7,548,676 | $ | 7,419,306 | $ | 7,539,741 | $ | 9,886,509 | |||||||||
Total revenue | 7,548,676 | 7,419,306 | 7,539,741 | 9,886,509 | |||||||||||||
Operating expenses | 4,651,396 | 4,426,615 | 3,628,176 | 3,112,431 | |||||||||||||
Income before income tax expense | 2,904,691 | 2,999,457 | 6,752,169 | 7,018,415 | |||||||||||||
Income tax expense | — | — | — | — | |||||||||||||
Net income attributable to common stockholders | $ | 2,904,691 | $ | 2,999,457 | $ | 6,752,169 | $ | 7,018,415 | |||||||||
Basic net income per common share | $ | 0.09 | $ | 0.1 | $ | 0.21 | $ | 0.22 | |||||||||
Diluted net income per common share | $ | 0.09 | $ | 0.09 | $ | 0.2 | $ | 0.21 | |||||||||
Shares used in computing basic net income per common share | 30,743,966 | 31,022,557 | 31,589,192 | 32,083,752 | |||||||||||||
Shares used in computing diluted net income per common share | 32,489,969 | 32,604,123 | 32,949,779 | 33,353,631 | |||||||||||||
Comprehensive income | $ | 2,904,691 | $ | 2,999,457 | $ | 6,752,169 | $ | 7,018,415 | |||||||||
2013 | |||||||||||||||||
1st Quarter | 2nd Quarter | 3rd Quarter | 4th Quarter | ||||||||||||||
Revenue | |||||||||||||||||
Licensed revenue | $ | 1,415,000 | $ | 1,651,000 | $ | 2,583,000 | $ | 4,673,000 | |||||||||
Total revenue | 1,415,000 | 1,651,000 | 2,583,000 | 4,673,000 | |||||||||||||
Operating expenses | 7,217,983 | 5,654,378 | 7,364,190 | 6,869,308 | |||||||||||||
Loss before income tax benefit | (5,777,932 | ) | (3,987,996 | ) | (4,767,193 | ) | (2,175,178 | ) | |||||||||
Income tax expense | — | — | — | — | |||||||||||||
Net loss attributable to common stockholders | $ | (5,777,932 | ) | $ | (3,987,996 | ) | $ | (4,767,193 | ) | $ | (2,175,178 | ) | |||||
Basic and diluted net loss per common share | $ | (0.19 | ) | $ | (0.13 | ) | $ | (0.16 | ) | $ | (0.07 | ) | |||||
Shares used in computing basic and diluted net loss per common share | 30,336,398 | 30,403,670 | 30,476,562 | 30,353,631 | |||||||||||||
Comprehensive Loss | $ | (5,774,679 | ) | $ | (3,987,996 | ) | $ | (4,767,193 | ) | $ | (2,175,178 | ) |
Significant_Accounting_Policie3
Significant Accounting Policies (Details) (USD $) | 12 Months Ended |
Dec. 31, 2014 | |
General [Abstract] | |
Special cash distribution to all stockholders of record (in dollars per share) | $1.75 |
Date of declaration for special cash distribution | 21-Nov-13 |
Date of record for special cash distribution | 11-Dec-13 |
Payment date for special cash distribution | 30-Dec-13 |
Significant_Accounting_Policie4
Significant Accounting Policies, Revenue Recognition (Details) (USD $) | 3 Months Ended | 12 Months Ended | 1 Months Ended | ||||||||||
Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2013 | Sep. 30, 2013 | Jun. 30, 2013 | Mar. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Mar. 31, 2011 | Sep. 30, 2011 | |
Licensing Revenue [Abstract] | |||||||||||||
Royalty Revenue | $21,136,932 | $6,322,000 | $4,849,000 | ||||||||||
Other licensing revenue | 11,257,300 | 4,000,000 | 500,000 | ||||||||||
Total licensing revenue | 9,886,509 | 7,539,741 | 7,419,306 | 7,548,676 | 4,673,000 | 2,583,000 | 1,651,000 | 1,415,000 | 32,394,232 | 10,322,000 | 5,349,000 | ||
Cilag GmbH International [Member] | |||||||||||||
Licensing Revenue [Abstract] | |||||||||||||
Initial upfront license payment | 257,300 | ||||||||||||
Sanofil-aventis U.S. LLC [Member] | |||||||||||||
Licensing Revenue [Abstract] | |||||||||||||
Total licensing revenue | $15,000,000 |
Significant_Accounting_Policie5
Significant Accounting Policies, Cash, Cash Equivalents, Investments and Concentration of Credit Risk (Details) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Aug. 20, 2014 | Dec. 31, 2013 | |
Cash and Cash Equivalents and Concentration of Credit Risk [Abstract] | |||
Restricted cash and cash equivalents | $42,000 | ||
Cash, FDIC insured amount | 250,000 | ||
Percentage of insured cash held in bank deposits (in hundredths) | 55.00% | ||
Percentage of insured cash held by market mutual fund managers (in hundredths) | 45.00% | ||
Assets: [Abstract] | |||
Cash and cash equivalents | 40,582,415 | 32,827,732 | |
Investments in Pernix warrants | 2,678,773 | 0 | |
Total cash and investments | 43,261,188 | 32,827,732 | |
Fair Value Measurement [Abstract] | |||
Number of securities called by warrants (in shares) | 500,000 | ||
Exercise price of warrants (in dollars per share) | $4.28 | ||
Date from which warrants exercisable | 20-Aug-14 | ||
Number of shares under the terms of the warrant (in shares) | 222,656 | ||
Value of shares under the terms of the warrant | 1,700,000 | ||
Valuation of investments in warrants | 2,740,800 | 2,740,800 | |
Mark to market adjustment | -62,027 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Cash and cash equivalents | 40,582,415 | 32,827,732 | |
Investments in warrants | 2,678,773 | 0 | |
Total cash and investments | 43,261,188 | 32,827,732 | |
Recurring [Member] | |||
Assets: [Abstract] | |||
Cash and cash equivalents | 40,582,415 | 32,827,732 | |
Investments in Pernix warrants | 2,678,773 | 0 | |
Total cash and investments | 43,261,188 | 32,827,732 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Cash and cash equivalents | 40,582,415 | 32,827,732 | |
Investments in warrants | 2,678,773 | 0 | |
Total cash and investments | 43,261,188 | 32,827,732 | |
Recurring [Member] | Quoted prices in active Markets for identical items (Level 1) [Member] | |||
Assets: [Abstract] | |||
Cash and cash equivalents | 40,582,415 | 32,827,732 | |
Investments in Pernix warrants | 0 | 0 | |
Total cash and investments | 40,582,415 | 32,827,732 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Cash and cash equivalents | 40,582,415 | 32,827,732 | |
Investments in warrants | 0 | 0 | |
Total cash and investments | 40,582,415 | 32,827,732 | |
Recurring [Member] | Significant other observable inputs (Level 2) [Member] | |||
Assets: [Abstract] | |||
Cash and cash equivalents | 0 | 0 | |
Investments in Pernix warrants | 2,678,773 | 0 | |
Total cash and investments | 2,678,773 | 0 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Cash and cash equivalents | 0 | 0 | |
Investments in warrants | 2,678,773 | 0 | |
Total cash and investments | 2,678,773 | 0 | |
Recurring [Member] | Significant unobservable inputs (Level 3) [Member] | |||
Assets: [Abstract] | |||
Cash and cash equivalents | 0 | 0 | |
Investments in Pernix warrants | 0 | 0 | |
Total cash and investments | 0 | 0 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Cash and cash equivalents | 0 | 0 | |
Investments in warrants | 0 | 0 | |
Total cash and investments | $0 | $0 |
Significant_Accounting_Policie6
Significant Accounting Policies, Equipment (Details) (USD $) | 12 Months Ended | |
In Millions, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 |
Property, Plant and Equipment [Line Items] | ||
Accumulated depreciation | 0.7 | $0.70 |
Minimum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimated useful lives | 5 years | |
Maximum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimated useful lives | 7 years |
Significant_Accounting_Policie7
Significant Accounting Policies, Interest and Other Income (Details) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Aug. 20, 2014 | |
Interest and Other Income [Abstract] | |||
Interest and Other Income | $43,100 | $138,900 | |
Available-for-sale Securities, Equity Securities, Current | 2,740,800 | 2,740,800 | |
Realized Investment Gains (Losses) | -62,027 | ||
Disgorgement of short-swing profits | $377,269 |
Significant_Accounting_Policie8
Significant Accounting Policies, Net Income (Loss) Per Share (Details) | 3 Months Ended | 12 Months Ended | |||||
Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Net Income (Loss) Per Share [Abstract] | |||||||
Basis weighted average shares outstanding (in shares) | 32,083,752 | 31,589,192 | 31,022,557 | 30,743,966 | 31,359,867 | 30,449,721 | 30,091,985 |
Effect of dilutive employee and director awards (in shares) | 1,450,720 | 0 | 0 | ||||
Diluted weighted-average shares outstanding and assumed conversions (in shares) | 33,353,631 | 32,949,779 | 32,604,123 | 32,489,969 | 32,810,587 | 30,449,721 | 30,091,985 |
Significant_Accounting_Policie9
Significant Accounting Policies, Contingencies (Details) (USD $) | 12 Months Ended |
In Millions, unless otherwise specified | Dec. 31, 2014 |
Contingencies [Abstract] | |
Legal Fees | $17.50 |
License_Agreements_Details
License Agreements (Details) (USD $) | 3 Months Ended | 12 Months Ended | 1 Months Ended | 3 Months Ended | 12 Months Ended | 0 Months Ended | ||||||||||||||||||
Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2013 | Sep. 30, 2013 | Jun. 30, 2013 | Mar. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Apr. 26, 2008 | Oct. 31, 2005 | 31-May-04 | Jun. 30, 2003 | Sep. 30, 2007 | Sep. 30, 2006 | Jun. 30, 2010 | Dec. 31, 2010 | Dec. 19, 2011 | Aug. 20, 2014 | 13-May-14 | Sep. 06, 2007 | Jul. 10, 2013 | |
Payment | ||||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||
Royalty and licensing revenue | $9,886,509 | $7,539,741 | $7,419,306 | $7,548,676 | $4,673,000 | $2,583,000 | $1,651,000 | $1,415,000 | $32,394,232 | $10,322,000 | $5,349,000 | |||||||||||||
Exercise price of warrants (in dollars per share) | $4.28 | $4.28 | ||||||||||||||||||||||
GlaxoSmithKline [Member] | ||||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||
Initial payment received for license agreement | 25,000,000 | |||||||||||||||||||||||
Milestone payments received for license agreement | 20,000,000 | 20,000,000 | 15,000,000 | |||||||||||||||||||||
Number of sales performance milestone payment received upon target achieved | 2 | |||||||||||||||||||||||
Receivables under license agreement | 80,000,000 | |||||||||||||||||||||||
Maximum additional payment receivable per product upon achievement of milestones | 10,000,000 | |||||||||||||||||||||||
Pernix [Member] | ||||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||
Future minimum royalty amount, thereafter | 4,000,000 | |||||||||||||||||||||||
Warrant to purchase common stock (in shares) | 500,000 | |||||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $4.28 | |||||||||||||||||||||||
AstraZeneca AB [Member] | ||||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||
Milestone payments received for license agreement | 20,000,000 | 25,000,000 | ||||||||||||||||||||||
Upfront license fee received | 40,000,000 | |||||||||||||||||||||||
Amount in connection with execution of amendment agreement | 10,000,000 | |||||||||||||||||||||||
Amount received in recognition of the achievement of the primary endpoints | 20,000,000 | |||||||||||||||||||||||
Period of comparative trial | 6 months | |||||||||||||||||||||||
Period after the first commercial sale of the product gives the right to receive royalties | 10 years | |||||||||||||||||||||||
Period after written notice to cure the breach otherwise to terminate the agreement | 90 days | |||||||||||||||||||||||
AstraZeneca AB [Member] | Maximum [Member] | ||||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||
Receivables under license agreement | 260,000,000 | 345,000,000 | ||||||||||||||||||||||
AstraZeneca AB [Member] | V I M O V O [Member] | ||||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||
Accrued royalty revenue | 5,600,000 | 5,600,000 | ||||||||||||||||||||||
Minimum royalty amount year one | 5,000,000 | 5,000,000 | ||||||||||||||||||||||
Future minimum royalty amount, thereafter | 7,500,000 | 7,500,000 | ||||||||||||||||||||||
AstraZeneca AB [Member] | V I M O V O [Member] | U.S. [Member] | ||||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||
Accrued royalty revenue | 4,300,000 | 4,300,000 | ||||||||||||||||||||||
AstraZeneca AB [Member] | V I M O V O [Member] | Foreign [Member] | ||||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||
Accrued royalty revenue | 1,300,000 | 1,300,000 | ||||||||||||||||||||||
Cilag GmbH International [Member] | ||||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||
Royalty and licensing revenue | 257,300 | |||||||||||||||||||||||
Patheon Pharmaceuticals Inc. [Member] | ||||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||
Period for which the supply agreement can be renewed | 2 years | |||||||||||||||||||||||
Notice period to terminate the supply agreement prior to the expiration of the initial term | 18 months | |||||||||||||||||||||||
Notice period to terminate the supply agreement prior to the expiration of any renewal term | 12 months | |||||||||||||||||||||||
Notice period to terminate the supply agreement in case of material uncured breaches | 30 days | |||||||||||||||||||||||
Notice period to terminate the supply agreement if we transfer any rights to commercialize the product to a third party | 24 months | |||||||||||||||||||||||
Expected cost of purchasing certain equipment specific to the manufacture the product | 150,000 | |||||||||||||||||||||||
Maximum cost of additional equipment and facility modifications | $2,500,000 | $1,200,000 |
Stockholders_Equity_Details
Stockholders' Equity (Details) (USD $) | 12 Months Ended | |
Dec. 31, 2014 | Dec. 31, 2013 | |
Equity, Class of Treasury Stock [Line Items] | ||
Number of preferred share purchase right (in shares) | 1 | |
Common stock, par value (in dollars per share) | $0.00 | $0.00 |
Minimum percentage of beneficial ownership to trigger rights and become exercisable (in hundredths) | 15.00% | |
Minimum percentage of common stock announces as a tender offer (in hundredths) | 15.00% | |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, par value (in dollars per share) | $0.00 | $0.00 |
Percentage of current market price per share (in hundredths) | 50.00% | |
Redemption value of the right (in dollars per right) | $0.00 | |
Term of rights plan | 10 years | |
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) | 2,474,430 | |
Common shares issuable pursuant to options and restricted stock units granted under equity compensations plans (in shares) | 3,817,920 | |
Rights Plan shares issuable as Series A Junior Participating Preferred Stock (in shares) | 90,000 | |
Total reserved (in shares) | 6,382,350 | |
Series A Junior Participating Preferred Stock [Member] | ||
Equity, Class of Treasury Stock [Line Items] | ||
Preferred stock, shares authorized (in shares) | 90,000 | 90,000 |
Preferred stock, par value (in dollars per share) | $0.00 | $0.00 |
Purchase price (in dollars per one-one-thousandth of a share) | $80 |
Accrued_Expenses_Details
Accrued Expenses (Details) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
Accrued expenses [Abstract] | ||
Research and development costs | $55,227 | $1,025,995 |
Other | 198,397 | 629,217 |
Total | $253,624 | $1,655,212 |
Income_Taxes_Details
Income Taxes (Details) (USD $) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2013 | Sep. 30, 2013 | Jun. 30, 2013 | Mar. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Operating Loss Carryforwards [Line Items] | |||||||||||
Research and development credit carryforwards, expiration date | 31-Dec-18 | ||||||||||
Recognized tax benefits related to net operating loss carryforward | $5,000,000 | $0 | $0 | ||||||||
Increase in valuation allowance | -30,000 | ||||||||||
State corporate income tax rate for 2013 (in hundredths) | 6.90% | ||||||||||
State Corporate Income Tax Rate For 2014 (in hundredths) | 6.00% | ||||||||||
State Corporate Income Tax Rate For 2015 (in hundredths) | 5.00% | ||||||||||
Significant components of the Company's deferred tax assets [Abstract] | |||||||||||
Other current assets | 662,000 | 1,080,000 | 662,000 | 1,080,000 | |||||||
Less valuation allowance | -647,000 | -1,080,000 | -647,000 | -1,080,000 | |||||||
Total net deferred income tax assets, current | 15,000 | 0 | 15,000 | 0 | |||||||
Deferred Tax Liabilities, Investments | -968,000 | 0 | -968,000 | 0 | |||||||
Total net deferred income taxes, current | 952,900 | 0 | 952,900 | 0 | |||||||
Net operating loss carryforwards | 20,840,000 | 25,909,000 | 20,840,000 | 25,909,000 | |||||||
Research and development credits | 13,987,000 | 13,992,000 | 13,987,000 | 13,992,000 | |||||||
Equity compensation and other | 6,683,000 | 7,549,000 | 6,683,000 | 7,549,000 | |||||||
Total deferred tax assets | 41,510,000 | 47,450,000 | 41,510,000 | 47,450,000 | |||||||
Valuation allowance | -40,557,000 | -47,450,000 | -40,557,000 | -47,450,000 | |||||||
Deferred Tax Liabilities, Net, Noncurrent | 953,000 | 0 | 953,000 | 0 | |||||||
Total net deferred income taxes | 0 | 0 | 0 | 0 | |||||||
Effective Income Tax Reconciliation [Abstract] | |||||||||||
(Loss) income before income tax benefit | 7,018,415 | 6,752,169 | 2,999,457 | 2,904,691 | -2,175,178 | -4,767,193 | -3,987,996 | -5,777,932 | -19,674,732 | -16,708,299 | -25,283,021 |
Federal tax rate (in hundredths) | 35.00% | 35.00% | 35.00% | ||||||||
Federal income tax provision at statutory rate | 6,886,000 | -5,848,000 | -8,849,000 | ||||||||
State tax provision | 224,000 | -215,000 | -343,000 | ||||||||
Total Tax Provision | 7,110,000 | -6,063,000 | -9,192,000 | ||||||||
Decrease (increase) in income tax benefit resulting from: | |||||||||||
Research and development credits | 4,000 | 66,000 | 0 | ||||||||
Non-deductible expenses and other | 117,000 | 302,000 | 409,000 | ||||||||
Change in state tax rate | 35,000 | 966,000 | 0 | ||||||||
Change in valuation allowance | -7,326,000 | 4,729,000 | 8,783,000 | ||||||||
Income tax expense | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Gross unrecognized tax positions [Roll Forward] | |||||||||||
Gross tax liability, Opening Balance | 538,000 | 538,000 | |||||||||
Additions/Decreases for tax positions of the prior year | -1,000 | ||||||||||
Additions/Decreases for tax positions of the current year | 0 | ||||||||||
Gross tax liability, Ending Balance | 537,000 | 538,000 | 537,000 | 538,000 | |||||||
Research and Development Credit [Member] | |||||||||||
Operating Loss Carryforwards [Line Items] | |||||||||||
Increase in deferred tax assets | 20,000 | ||||||||||
Increase in valuation allowance | 110,000 | ||||||||||
Federal [Member] | |||||||||||
Operating Loss Carryforwards [Line Items] | |||||||||||
Net operating loss carryforwards | 53,000,000 | 66,800,000 | 53,000,000 | 66,800,000 | |||||||
Operating loss carryforwards, expiration dates | 31-Dec-26 | ||||||||||
State [Member] | |||||||||||
Operating Loss Carryforwards [Line Items] | |||||||||||
Net operating loss carryforwards | $78,000,000 | $82,900,000 | $78,000,000 | $82,900,000 | |||||||
Operating loss carryforwards, expiration dates | 31-Dec-14 |
Equity_Compensation_Plans_Deta
Equity Compensation Plans (Details) (USD $) | 12 Months Ended | 1 Months Ended | 12 Months Ended | 1 Months Ended | |||||||||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2010 | Apr. 30, 2010 | Sep. 30, 2008 | 31-May-08 | Dec. 31, 2011 | Dec. 31, 2008 | Oct. 31, 2011 | Jun. 30, 2007 | 31-May-04 | 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 | ||||||||||||
Time-based non-vested awards, weighted average exercise price [Roll Forward] | |||||||||||||
Share-based compensation expense | $1,880,962 | $3,962,386 | $2,729,920 | ||||||||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||||||||||||
Total expense | 1,880,962 | 3,962,386 | 2,729,920 | ||||||||||
Research and Development Expense [Member] | |||||||||||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||||||||||||
Total expense | 295,631 | 765,526 | 461,118 | ||||||||||
Selling, General and Administrative Expenses [Member] | |||||||||||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||||||||||||
Total expense | 1,585,331 | 3,196,860 | 2,268,802 | ||||||||||
Time-Based Stock Awards [Member] | |||||||||||||
Time-Based Stock Awards Fair Value Assumptions [Abstract] | |||||||||||||
Expected volatility rate (in hundredths) | 63.70% | ||||||||||||
Expected volatility, minimum (in hundredths) | 68.00% | ||||||||||||
Expected volatility, maximum (in hundredths) | 72.30% | ||||||||||||
Expected dividends (in hundredths) | 0.00% | 0.00% | |||||||||||
Expected terms | 6 years | 6 years | |||||||||||
Risk free interest rate (in hundredths) | 1.25% | ||||||||||||
Risk free interest rate, minimum (in hundredths) | 0.91% | ||||||||||||
Risk free interest rate, maximum (in hundredths) | 1.33% | ||||||||||||
Weighted average grant date fair value (in dollars per share) | $5.35 | $4.87 | |||||||||||
Time-Based Awards [Roll Forward] | |||||||||||||
Outstanding at beginning of period (in shares) | 4,315,000 | ||||||||||||
Granted (in shares) | 0 | ||||||||||||
Exercised (in shares) | -1,479,000 | 138,562 | 252,398 | ||||||||||
Forfeited or expired (in shares) | -495,000 | ||||||||||||
Outstanding at end of period (in shares) | 2,341,000 | 4,315,000 | |||||||||||
Exercisable at end of period (in shares) | 1,865,000 | ||||||||||||
Vested and expected to vest at end of period (in shares) | 2,270,000 | ||||||||||||
Weighted Average Exercise Price [Roll Forward] | |||||||||||||
Outstanding at beginning of period (in dollars per share) | $6.82 | ||||||||||||
Granted (in dollars per share) | $0 | ||||||||||||
Exercised (in dollars per share) | $5.34 | ||||||||||||
Forfeited or expired (in dollars per share) | $8.52 | ||||||||||||
Outstanding at end of period (in dollars per share) | $7.39 | $6.82 | |||||||||||
Exercisable at end of period (in dollars per share) | $8.29 | ||||||||||||
Vested or expected to vest at end of year (in dollars per share) | $7.39 | ||||||||||||
Average Remaining Contractual Term [Abstract] | |||||||||||||
Outstanding, average remaining contractual term | 4 years 1 month 6 days | 4 years 3 months 18 days | |||||||||||
Outstanding, average remaining contractual term | 4 years 1 month 6 days | 4 years 3 months 18 days | |||||||||||
Exercisable, average remaining contractual term | 3 years 4 months 24 days | ||||||||||||
Vested or expected to vest, average remaining contractual term | 4 years 1 month 6 days | ||||||||||||
Aggregate Intrinsic Value [Abstract] | |||||||||||||
Outstanding , aggregate intrinsic value at beginning of period | 8,553,000 | ||||||||||||
Outstanding, aggregate intrinsic value at end of period | 4,382,000 | 8,553,000 | |||||||||||
Exercisable, aggregate intrinsic value | 2,402,000 | ||||||||||||
Vested and expected to vest, aggregate intrinsic value | 4,248,000 | ||||||||||||
Fair value of shares vested | 1,100,000 | 600,000 | 400,000 | ||||||||||
Time-based nonvested awards, shares [Roll Forward] | |||||||||||||
Nonvested outstanding beginning of period (in shares) | 760,000 | ||||||||||||
Grants (in shares) | 0 | ||||||||||||
Forfeited or expired (in shares) | -7,000 | ||||||||||||
Vested (in shares) | -276,000 | ||||||||||||
Nonvested outstanding end of period (in shares) | 477,000 | 760,000 | |||||||||||
Time-based non-vested awards, weighted average exercise price [Roll Forward] | |||||||||||||
Nonvested outstanding at beginning of period (in dollars per share) | $4.06 | ||||||||||||
Granted (in dollars per share) | $0 | ||||||||||||
Forfeited or expired (in dollars per share) | $3.87 | ||||||||||||
Vested (in dollars per share) | $4.47 | ||||||||||||
Nonvested outstanding at end of period (in dollars per share) | $3.85 | $4.06 | |||||||||||
Performance-Based Awards [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Unrecognized stock-based compensation expense | 6,000 | ||||||||||||
Time-Based Awards [Roll Forward] | |||||||||||||
Exercised (in shares) | 46,000 | 162,000 | 0 | ||||||||||
Aggregate Intrinsic Value [Abstract] | |||||||||||||
Total intrinsic value of stock options exercised | 4,600,000 | 589,000 | 304,000 | ||||||||||
Time-based non-vested awards, weighted average exercise price [Roll Forward] | |||||||||||||
Share-based compensation expense | 11,000 | ||||||||||||
Performance-Based Awards, Restricted Stock and Stock Units [Roll Forward] | |||||||||||||
Awards outstanding at beginning of period (in shares) | 540,000 | ||||||||||||
Granted (in shares) | 73,000 | ||||||||||||
Vested and released (in shares) | -46,000 | ||||||||||||
Forfeited or expired (in shares) | -199,000 | -37,000 | -204,123 | ||||||||||
Awards outstanding at end of period (in shares) | 368,000 | 540,000 | |||||||||||
Restricted stock and performance-based awards, Weighted-Average Exercise Price [Roll Forward] | |||||||||||||
Outstanding at beginning of period (in dollars per share) | $6.76 | ||||||||||||
Granted (in dollars per share) | $7.89 | ||||||||||||
Exercised (in dollars per share) | $1.99 | ||||||||||||
Forfeited or expired (in dollars per share) | $5.77 | ||||||||||||
Outstanding at end of period (in dollars per share) | $8.12 | $6.76 | |||||||||||
Total fair value of awards that vested | 0 | 1,000,000 | 0 | ||||||||||
Non vested shares outstanding at the end of the period (in shares) | 139,000 | ||||||||||||
Shares vested during the period (in shares) | 231,000 | ||||||||||||
Performance-Based Awards [Abstract] | |||||||||||||
Intrinsic value | 1,300,000 | ||||||||||||
Remaining contractual life | 5 years 2 months 12 days | ||||||||||||
Outstanding, vested as of end of period (in shares) | 229,000 | ||||||||||||
Performance-Based Awards [Member] | Executive Officer [Member] | |||||||||||||
Performance-Based Awards, Restricted Stock and Stock Units [Roll Forward] | |||||||||||||
Granted (in shares) | 105,000 | ||||||||||||
Restricted stock and performance-based awards, Weighted-Average Exercise Price [Roll Forward] | |||||||||||||
Stock awards granted (in shares) | 65,000 | ||||||||||||
Performance-Based Awards [Member] | Employees [Member] | |||||||||||||
Performance-Based Awards, Restricted Stock and Stock Units [Roll Forward] | |||||||||||||
Granted (in shares) | 208,740 | ||||||||||||
Restricted Stock and Restricted Stock Units [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Unrecognized stock-based compensation expense | 3,800,000 | ||||||||||||
Time-based non-vested awards, weighted average exercise price [Roll Forward] | |||||||||||||
Share-based compensation expense | 1,000,000 | 1,200,000 | 1,000,000 | ||||||||||
Performance-Based Awards, Restricted Stock and Stock Units [Roll Forward] | |||||||||||||
Awards outstanding at beginning of period (in shares) | 747,000 | ||||||||||||
Granted (in shares) | 450,000 | ||||||||||||
Vested and released (in shares) | -84,000 | ||||||||||||
Forfeited or expired (in shares) | -4,000 | ||||||||||||
Awards outstanding at end of period (in shares) | 1,109,000 | 747,000 | |||||||||||
Restricted stock and performance-based awards, Weighted-Average Exercise Price [Roll Forward] | |||||||||||||
Outstanding at beginning of period (in dollars per share) | $6.22 | ||||||||||||
Granted (in dollars per share) | $8.32 | ||||||||||||
Vested and released (in dollars per share) | $5.32 | ||||||||||||
Forfeited or expired (in dollars per share) | $5.91 | ||||||||||||
Outstanding at end of period (in dollars per share) | $7.14 | $6.22 | |||||||||||
Total fair value of awards that vested | 726,000 | 863,000 | 920,000 | ||||||||||
Total Stock Awards [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Estimated weighted-average amortization period | 2 years | ||||||||||||
Unrecognized stock-based compensation expense | $4,100,000 | ||||||||||||
Restricted Stock Units [Member] | |||||||||||||
Restricted stock and performance-based awards, Weighted-Average Exercise Price [Roll Forward] | |||||||||||||
Stock awards outstanding (in shares) | 627,000 | 523,000 | 430,000 | ||||||||||
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 share 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 | ||||||||||||
PN Incentive Program [Member] | Performance-Based Awards [Member] | |||||||||||||
Restricted stock and performance-based awards, Weighted-Average Exercise Price [Roll Forward] | |||||||||||||
Granted (in dollars per share) | $10.82 | $14.45 | |||||||||||
Stock awards granted (in shares) | 11,700 | 281,433 | |||||||||||
Performance-Based Awards [Abstract] | |||||||||||||
Percentage of the options granted and vested (in hundredths) | 75.00% | 25.00% | |||||||||||
Term of awards | 10 years | 10 years | |||||||||||
PN Incentive Program [Member] | Performance-Based Awards [Member] | Executive Officer [Member] | |||||||||||||
Restricted stock and performance-based awards, Weighted-Average Exercise Price [Roll Forward] | |||||||||||||
Stock awards granted (in shares) | 20,000 | ||||||||||||
PA Incentive Program [Member] | Performance-Based Awards [Member] | |||||||||||||
Restricted stock and performance-based awards, Weighted-Average Exercise Price [Roll Forward] | |||||||||||||
Stock awards granted (in shares) | 453,960 | ||||||||||||
Stock Options forfeited | 177,818 | 132,883 | |||||||||||
Performance-Based Awards [Abstract] | |||||||||||||
Percentage of stock options and RSUs to be vested upon the acceptance of the filing of a new drug application | 33.33% | 50.00% | |||||||||||
Percentage of the stock options and RSUs to be vested upon first cycle of NDA approval | 33.33% | 50.00% | |||||||||||
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% |
Leases_Details
Leases (Details) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
sqft | |||
Leases [Abstract] | |||
Rent expense | $419,000 | $419,000 | $419,000 |
Office space (in square feet) | 17,009 | ||
Additional lease term extension | 5 years 7 months | ||
Reduced lease renewal notice period | 0 years 7 months | ||
Lease extension option available | 3 years | ||
Increase in operating leases future minimum payments | 2,700,000 | ||
Deferred rent balance | $62,600 |
Retirement_Savings_Plan_Detail
Retirement Savings Plan (Details) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Retirement Savings Plan [Abstract] | |||
Minimum age of employees to cover under defined contribution plan | 21 years | ||
Company contributions to 401(k) plan | $141,887 | $191,582 | $224,420 |
Summary_of_Operations_by_Quart2
Summary of Operations by Quarters (Unaudited) (Details) (USD $) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2013 | Sep. 30, 2013 | Jun. 30, 2013 | Mar. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Revenue | |||||||||||
Licensed revenue | $9,886,509 | $7,539,741 | $7,419,306 | $7,548,676 | $4,673,000 | $2,583,000 | $1,651,000 | $1,415,000 | $32,394,232 | $10,322,000 | $5,349,000 |
Total revenue | 9,886,509 | 7,539,741 | 7,419,306 | 7,548,676 | 4,673,000 | 2,583,000 | 1,651,000 | 1,415,000 | |||
Operating expenses | 3,112,431 | 3,628,176 | 4,426,615 | 4,651,396 | 6,869,308 | 7,364,190 | 5,654,378 | 7,217,983 | 15,818,619 | 27,105,859 | 30,890,718 |
Income before income tax expense | 7,018,415 | 6,752,169 | 2,999,457 | 2,904,691 | -2,175,178 | -4,767,193 | -3,987,996 | -5,777,932 | -19,674,732 | -16,708,299 | -25,283,021 |
Loss before income tax benefit | 7,018,415 | 6,752,169 | 2,999,457 | 2,904,691 | -2,175,178 | -4,767,193 | -3,987,996 | -5,777,932 | -19,674,732 | -16,708,299 | -25,283,021 |
Income tax expense | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Net income (loss) attributable to common stockholders | 7,018,415 | 6,752,169 | 2,999,457 | 2,904,691 | -2,175,178 | -4,767,193 | -3,987,996 | -5,777,932 | 19,674,732 | -16,708,299 | -25,283,021 |
Basic net income per common share | $0.22 | $0.21 | $0.10 | $0.09 | $0.63 | ($0.55) | ($0.84) | ||||
Diluted net income per common share | $0.21 | $0.20 | $0.09 | $0.09 | $0.60 | ($0.55) | ($0.84) | ||||
Basic and diluted net loss per common share (in dollars per share) | ($0.07) | ($0.16) | ($0.13) | ($0.19) | |||||||
Shares used in computing basic net income per common share | 32,083,752 | 31,589,192 | 31,022,557 | 30,743,966 | 31,359,867 | 30,449,721 | 30,091,985 | ||||
Shares used in computing diluted net income per common share | 33,353,631 | 32,949,779 | 32,604,123 | 32,489,969 | 32,810,587 | 30,449,721 | 30,091,985 | ||||
Shares used in computing basic and diluted net loss per common share (in shares) | 30,353,631 | 30,476,562 | 30,403,670 | 30,336,398 | |||||||
Comprehensive income (loss) | $7,018,415 | $6,752,169 | $2,999,457 | $2,904,691 | ($2,175,178) | ($4,767,193) | ($3,987,996) | ($5,774,679) | $19,674,732 | ($16,705,046) | ($25,268,633) |