Document_and_Entity_Informatio
Document and Entity Information Document | 9 Months Ended | |
Jun. 30, 2014 | Aug. 08, 2014 | |
Document and Entity Information [Abstract] | ' | ' |
Entity Registrant Name | 'Eagle Pharmaceuticals, Inc. | ' |
Entity Central Index Key | '0000827871 | ' |
Current Fiscal Year End Date | '--09-30 | ' |
Entity Filer Category | 'Non-accelerated Filer | ' |
Document Type | '10-Q | ' |
Document Period End Date | 30-Jun-14 | ' |
Document Fiscal Year Focus | '2014 | ' |
Document Fiscal Period Focus | 'Q3 | ' |
Amendment Flag | 'false | ' |
Entity Common Stock, Shares Outstanding | ' | 14,020,133 |
Condensed_Balance_Sheets
Condensed Balance Sheets (USD $) | Jun. 30, 2014 | Sep. 30, 2013 |
Current assets: | ' | ' |
Cash and cash equivalents | $49,790,920 | $10,455,565 |
Accounts receivable | 6,712,244 | 5,124,182 |
Inventories | 329,034 | 0 |
Prepaid expenses and other current assets | 922,930 | 1,902,660 |
Total current assets | 57,755,128 | 17,482,407 |
Property and equipment, net | 359,509 | 402,286 |
Other assets | 45,000 | 46,320 |
Deferred initial public offering costs | 0 | 171,607 |
Total assets | 58,159,637 | 18,102,620 |
Current liabilities | ' | ' |
Accounts payable | 2,520,523 | 1,192,600 |
Accrued expenses | 7,468,794 | 3,129,552 |
Deferred revenue | 6,259,653 | 10,019,653 |
Total current liabilities | 16,248,970 | 14,341,805 |
Redeemable Series C Preferred Stock warrants | 0 | 1,706,829 |
Shares subject to redemption | ' | ' |
Commitments and contingencies | ' | ' |
Stockholders' Equity (Deficit): | ' | ' |
Preferred stock, 1,500,000 shares authorized and no shares issued or outstanding as of June 30, 2014; no shares authorized, issued or outstanding as of September 30, 2013 | 0 | 0 |
Common stock, $0.001 par value; 50,000,000 and 80,000,000 shares authorized as of June 30, 2014 and September 30, 2013, respectively; 14,020,133 and 3,048,131 issued and outstanding as of June 30, 2014 and September 30, 2013, respectively | 14,020 | 3,048 |
Additional paid in capital | 136,970,460 | 14,203,995 |
Accumulated deficit | -95,073,813 | -102,136,057 |
Total stockholders' equity (deficit) | 41,910,667 | -87,929,014 |
Total liabilities, shares subject to redemption and stockholders' equity (deficit) | $58,159,637 | $18,102,620 |
Condensed_Balance_Sheets_Paren
Condensed Balance Sheets (Parentheticals) (USD $) | Jun. 30, 2014 | Sep. 30, 2013 |
Preferred Stock, Shares Authorized | 1,500,000 | ' |
Preferred Stock, Shares Issued | 0 | ' |
Preferred Stock, Shares Outstanding | 0 | ' |
Common Stock, par value per share | $0.00 | $0.00 |
Common stock, shares authorized | 50,000,000 | 80,000,000 |
Common stock, shares, issued | 14,020,133 | 3,048,131 |
Common stock, shares, outstanding | 14,020,133 | 3,048,131 |
Condensed_Statements_of_Operat
Condensed Statements of Operations (USD $) | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | |
Revenues | ' | ' | ' | ' |
Product sales | $350,350 | $2,489,310 | $3,748,800 | $3,689,640 |
Royalty income | 1,941,526 | 2,585,719 | 8,774,407 | 5,349,289 |
Other income | 3,500,000 | 0 | 3,765,000 | 0 |
Total revenue | 5,791,876 | 5,075,029 | 16,288,207 | 9,038,929 |
Operating expenses | ' | ' | ' | ' |
Cost of revenue | 1,555,711 | 2,925,046 | 9,539,436 | 4,449,337 |
Research and development | 4,545,158 | 1,632,280 | 10,927,912 | 6,375,896 |
Selling, general and administrative | 2,673,405 | 1,251,051 | 5,471,727 | 6,130,634 |
Professional fee benefit | 0 | -1,993,099 | 0 | -1,993,099 |
Total operating expenses | 8,774,274 | 3,815,278 | 25,939,075 | 14,962,768 |
Income/(loss) from operations | -2,982,398 | 1,259,751 | -9,650,868 | -5,923,839 |
Interest income | 17,826 | 1,036 | 26,647 | 2,156 |
Interest expense | -4,812 | -16,018 | -6,244 | -309,121 |
Deferred financing costs | 0 | -38,567 | 0 | -96,417 |
Amortization of debt discount | 0 | -436,350 | 0 | -1,090,878 |
Change in value of warrant liability | 0 | -15,608 | -573,582 | -15,608 |
Other income | 35,305 | 332 | 35,590 | 3,202 |
Total other income/(expense) | 48,319 | -505,175 | -517,589 | -1,506,666 |
Net Income/(Loss) before income tax benefit | -2,934,079 | 754,576 | -10,168,457 | -7,430,505 |
Income tax benefit | 0 | 0 | 1,294,905 | 898,703 |
Net Income/(Loss) | -2,934,079 | 754,576 | -8,873,552 | -6,531,802 |
Less dividends on Series A, B, B-1 and C Convertible Preferred Stock | 0 | -1,074,637 | -1,666,063 | -2,704,567 |
Net loss attributable to common stockholders | ($2,934,079) | ($320,061) | ($10,539,615) | ($9,236,369) |
Loss per share attributable to common stockholders Basic and diluted (in usd per share) | ($0.21) | ($0.11) | ($1.23) | ($3.06) |
Weighted average common shares outstanding Basic and diluted (in shares) | 14,020,133 | 3,048,131 | 8,590,719 | 3,020,889 |
Condensed_Statements_of_Change
Condensed Statements of Changes in Stockholders' Equity (Deficit) Statement (USD $) | Total | Series A Convertible Preferred Stock | Series B Convertible Preferred Stock | Series B-1 Convertible Preferred Stock | Series C Convertible Preferred Stock | Series C Preferred Stock Warrants | Common stock | Common stock | Common stock | Common stock | Common stock | Common stock | Additional Paid-in Capital | Additional Paid-in Capital | Additional Paid-in Capital | Additional Paid-in Capital | Additional Paid-in Capital | Additional Paid-in Capital | Accumulated Deficit |
Series A Convertible Preferred Stock | Series B Convertible Preferred Stock | Series B-1 Convertible Preferred Stock | Series C Convertible Preferred Stock | Series C Preferred Stock Warrants | Series A Convertible Preferred Stock | Series B Convertible Preferred Stock | Series B-1 Convertible Preferred Stock | Series C Convertible Preferred Stock | Series C Preferred Stock Warrants | ||||||||||
Stockholders' equity attributable to parent, beginning balance at Sep. 30, 2013 | ($87,929,014) | ' | ' | ' | ' | ' | $3,048 | ' | ' | ' | ' | ' | $14,203,995 | ' | ' | ' | ' | ' | ($102,136,057) |
Number of shares outstanding, beginning balance at Sep. 30, 2013 | ' | ' | ' | ' | ' | ' | 3,048,131 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Stock-based compensation expense | 381,736 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 381,736 | ' | ' | ' | ' | ' | ' |
Issuance of common stock in connection with initial public offering, net of offering costs (in shares) | 3,450,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Issuance of common stock in connection with initial public offering, including underwriter's over-allotment, net of offering costs and underwriter's discount | 46,048,360 | ' | ' | ' | ' | ' | 3,450 | ' | ' | ' | ' | ' | 46,044,910 | ' | ' | ' | ' | ' | ' |
Conversion of preferred shares to common stock, (in shares) | ' | ' | ' | ' | ' | ' | ' | 2,332,051 | 1,980,431 | 1,455,753 | 1,719,693 | 32,286 | ' | ' | ' | ' | ' | ' | ' |
Conversion of preferred shares to common stock, value | ' | 20,376,622 | 30,612,234 | 19,756,221 | 20,902,812 | 2,280,443 | ' | 2,332 | 1,980 | 1,456 | 1,720 | 32 | ' | 20,374,290 | 30,610,254 | 19,754,765 | 20,901,092 | 2,280,411 | ' |
Issuance of common stock upon exercise of Redeemable Series C preferred stock warrants (in shares) | ' | ' | ' | ' | ' | ' | 1,788 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Issuance of common stock upon exercise of Redeemable Series C Preferred Stock warrants | 20,868 | ' | ' | ' | ' | ' | 2 | ' | ' | ' | ' | ' | 20,866 | ' | ' | ' | ' | ' | ' |
Dividends on Convertible Preferred Stock and forfeitures of dividends on conversion to common | 0 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | -17,601,859 | ' | ' | ' | ' | ' | 17,601,859 |
Net loss | -8,873,552 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Dividends on Convertible Preferred Stock | -1,666,063 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | -1,666,063 |
Stockholders' equity attributable to parent, ending balance at Jun. 30, 2014 | $41,910,667 | ' | ' | ' | ' | ' | $14,020 | ' | ' | ' | ' | ' | $136,970,460 | ' | ' | ' | ' | ' | ($95,073,813) |
Number of shares outstanding, ending balance at Jun. 30, 2014 | ' | ' | ' | ' | ' | ' | 14,020,133 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Condensed_Statements_of_Cash_F
Condensed Statements of Cash Flows (USD $) | 9 Months Ended | |
Jun. 30, 2014 | Jun. 30, 2013 | |
Cash flows from operating activities | ' | ' |
Net loss | ($8,873,552) | ($6,531,802) |
Adjustments to reconcile net loss to net cash used in operating activities | ' | ' |
Depreciation expense | 81,762 | 105,327 |
Stock-based compensation | 381,736 | 329,920 |
Non-cash interest expense | 0 | 309,121 |
Amortization of deferred financing costs | 0 | 96,417 |
Amortization of debt discount | 0 | 1,090,878 |
Change in fair value of warrant liability | 573,582 | 15,608 |
Changes in operating assets and liabilities | ' | ' |
(Increase) decrease in accounts receivable | -1,588,062 | 1,263,875 |
Increase in inventories | -329,034 | -199,666 |
Decrease (increase) in prepaid expenses and other current assets | 979,730 | -3,346,062 |
Decrease in other assets | 1,320 | 30,000 |
Increase in accounts payable | 1,327,923 | 194,775 |
(Decrease) increase in deferred revenue | -3,760,000 | 892,341 |
Increase in accrued expenses and other liabilities | 4,489,848 | 185,681 |
Net cash used in operating activities | -6,714,747 | -5,563,587 |
Cash flows from investing activities | ' | ' |
Purchase of property and equipment | -38,815 | -30,675 |
Proceeds from short term investments | 0 | 1,500,000 |
Net cash (used in) provided by investing activities | -38,815 | 1,469,325 |
Cash flows from financing activities | ' | ' |
Proceeds from issuance of Series C preferred stock, net of offering costs of $159,727 | 0 | 9,828,737 |
Series C preferred stock offering costs | -1,179 | ' |
Proceeds from exercise of preferred stock warrants | 20,868 | 0 |
Proceeds from issuance of common stock from initial public offering, net of issuance costs | 46,069,228 | 0 |
Net cash provided by (used in) financing activities | 46,088,917 | 9,828,737 |
Net increase (decrease) in cash | 39,335,355 | 5,734,475 |
Cash and cash equivalents at beginning of period | 10,455,565 | 5,066,886 |
Cash and cash equivalents at end of period | 49,790,920 | 10,801,361 |
Supplemental disclosures of cash flow information | ' | ' |
Interest | -6,244 | 0 |
Franchise taxes | 9,295 | 2,335 |
Conversion of note payable to Common Stock | ' | ' |
Conversion of note payable to Common Stock | 0 | 10,062,296 |
Preferred stock dividends | 0 | 2,704,567 |
Conversion of Preferred Stock and Accrued Dividends to Common Stock | ' | ' |
Conversion of note payable to Common Stock | ' | ' |
Conversion to Common Stock | 91,647,889 | 11,786,380 |
Conversion of Redeemable Warrant Liability to Common Stock | ' | ' |
Conversion of note payable to Common Stock | ' | ' |
Conversion to Common Stock | $2,280,443 | $0 |
Condensed_Statements_of_Cash_F1
Condensed Statements of Cash Flows Parenthetical (USD $) | 9 Months Ended |
Jun. 30, 2013 | |
Series C Preferred Stock [Member] | |
Net offering costs | ($159,727) |
Interim_Condensed_Financial_St
Interim Condensed Financial Statements | 9 Months Ended |
Jun. 30, 2014 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ' |
Interim Condensed Financial Statements | ' |
Interim Condensed Financial Statements | |
The accompanying unaudited interim condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) for interim information and pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) for reporting on Form 10-Q. Accordingly, certain information and footnote disclosures required for complete financial statements are not included herein. It is recommended that these condensed financial statements be read in conjunction with the financial statements and related notes that appear in Eagle Pharmaceuticals, Inc.'s (the "Company") final prospectus filed by the Company with the SEC on February 13, 2014, relating to the Company's Registration Statement on Form S-1 (File No. 001-36306) for the Company's initial public offering. In the opinion of management, all adjustments (consisting only of normal recurring adjustments) necessary for the fair presentation of the financial information for the interim periods reported have been made. Results of operations for the three and nine months ended June 30, 2014 are not necessarily indicative of the results for the year ending September 30, 2014 or any period thereafter. |
Organization_and_Business_Acti
Organization and Business Activities | 9 Months Ended |
Jun. 30, 2014 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ' |
Organization and Business Activities | ' |
Organization and Business Activities | |
Eagle Pharmaceuticals, Inc. is a pharmaceutical company focused on the development and commercialization of specialty and generic pharmaceutical products, primarily in the injectable arena within the hospital segment. The Company has agreements in place with development partners under which products will be jointly developed and profits from the sales of the products will be shared by the parties. The Company has a number of products currently under development and one currently being sold in the United States. | |
On February 18, 2014, the Company closed its initial public offering whereby the Company sold 3,350,000 shares of common stock, at a public offering price of $15.00 per share, before underwriting discounts and expenses. On March 18, 2014, the underwriters exercised an over-allotment option granted in connection with the offering of 100,000 shares of common stock at the initial public offering price, less the underwriter discount. The aggregate net proceeds received by the Company from the offering were $46,069,228. Included in this amount is $20,868 received from the exercise of Series C preferred stock warrants for 1,788 shares of common stock. | |
In connection with the initial public offering, the Company's Board of Directors approved a one-for-6.41 reverse stock split of the Company's common stock (that resulted in a proportional adjustment to the conversion ratio of the preferred stock warrants). All references to common stock, common stock equivalents and per share amounts have been changed retroactively in these condensed financial statements and accompanying footnotes have been retroactively adjusted for all periods presented to give effect to this reverse stock split, including reclassifying an equal amount to the reduction in par value of common stock to additional paid-in capital. | |
On the initial public offering date, all outstanding shares of preferred stock converted into 7,487,928 shares of common stock and the outstanding warrants were net exercised for 32,286 shares common stock at the initial public offering price. These transactions produced a significant increase in the number of shares outstanding which will impact the year-over-year comparability of the Company’s (loss) earnings per share calculations for the next twelve months. Following these transactions, the Company’s total issued common stock as of June 30, 2014 was 14,020,133 shares. |
Summary_of_Significant_Account
Summary of Significant Accounting Policies | 9 Months Ended | |||||||||||
Jun. 30, 2014 | ||||||||||||
Accounting Policies [Abstract] | ' | |||||||||||
Summary of Significant Accounting Policies | ' | |||||||||||
Summary of Significant Accounting Policies | ||||||||||||
Use of Estimates | ||||||||||||
The preparation of condensed financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed financial statements including disclosure of contingent assets and contingent liabilities at the date of the condensed financial statements and the reported amounts of revenues and expenses during the reporting period and accompanying notes. The Company's critical accounting policies are those that are both most important to the Company's financial condition and results of operations and require the most difficult, subjective or complex judgments on the part of management in their application, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. Because of the uncertainty of factors surrounding the estimates or judgments used in the preparation of the condensed financial statements, actual results may materially vary from these estimates. | ||||||||||||
Accounting Guidance Not Yet Adopted | ||||||||||||
In May 2014, the Financial Accounting Standards Board (the "FASB") issued Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers (ASU 2014-09), which supersedes nearly all existing revenue recognition guidance under U.S. GAAP. The core principle of ASU 2014-09 is to recognize revenues when promised goods or services are transferred to customers in an amount that reflects the consideration to which an entity expects to be entitled for those goods or services. ASU 2014-09 defines a five step process to achieve this core principle and, in doing so, more judgment and estimates may be required within the revenue recognition process than are required under existing U.S. GAAP. | ||||||||||||
The standard is effective for annual periods beginning after December 15, 2016, and interim periods therein, using either of the following transition methods: (i) a full retrospective approach reflecting the application of the standard in each prior reporting period with the option to elect certain practical expedients, or (ii) a retrospective approach with the cumulative effect of initially adopting ASU 2014-09 recognized at the date of adoption (which includes additional footnote disclosures). We are currently evaluating the impact of our pending adoption of ASU 2014-09 on our consolidated financial statements and have not yet determined the method by which we will adopt the standard in 2017. | ||||||||||||
Reclassifications | ||||||||||||
Certain reclassifications have been made to prior year amounts to conform with the current year presentation. | ||||||||||||
Cash and Cash Equivalents | ||||||||||||
The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents. All cash and cash equivalents are held in United States financial institutions. The carrying amount of cash and cash equivalents approximates its fair value due to its short-term nature. | ||||||||||||
The Company, at times, maintains balances with financial institutions in excess of the FDIC limit. | ||||||||||||
Fair Value of Financial Instruments | ||||||||||||
The Company's financial instruments consist of cash and cash equivalents, accounts receivable, and accounts payable. The carrying values of these financial instruments approximate their fair values due to their short term maturities. | ||||||||||||
Fair Value Measurements | ||||||||||||
U.S. GAAP establishes a framework for measuring fair value under generally accepted accounting principles and enhances disclosures about fair value measurements. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The standard describes the following fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value: | ||||||||||||
• | Level 1: Quoted prices in active markets for identical assets or liabilities. | |||||||||||
• | Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. | |||||||||||
• | Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. | |||||||||||
The fair value of interest-bearing cash and cash equivalents are classified as Level 1 at June 30, 2014 and September 30, 2013. | ||||||||||||
The Company is required by U.S. GAAP to record certain assets and liabilities at fair value on a recurring basis. | ||||||||||||
The guidance in ASC 815 required that the Company mark the value of its warrant liability (See Note 6) to market and recognize the change in valuation in its statement of operations each reporting period. Determining the warrant liability to be recorded required the Company to develop estimates to be used in calculating the fair value of the warrant. | ||||||||||||
Since these preferred stock warrants did not trade in an active securities market, the Company recognized a warrant liability and estimated the fair value of these warrants using a Probability-Weighted Expected Returns valuation model. Therefore, the warrant liability was considered a Level 3 measurement. All warrants outstanding immediately prior to the public offering were net exercised in connection with the initial public offering. There were no outstanding warrants as of June 30, 2014. | ||||||||||||
Concentration of Major Customers and Vendors | ||||||||||||
The Company's customers are its commercial and licensing partners. The Company is dependent on these commercial partners to market and sell argatroban, from which all of its current revenues are currently derived; therefore, the Company's future revenues are highly dependent on these collaboration and distribution arrangements. | ||||||||||||
The total revenues and accounts receivables broken down by major customers as a percentage of the total are as follows: | ||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||
June 30, | June 30, | |||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||
Net revenues | ||||||||||||
The Medicines Company | 51 | % | 42 | % | 42 | % | 53 | % | ||||
Sandoz, Inc. | 49 | % | 58 | % | 58 | % | 47 | % | ||||
100 | % | 100 | % | 100 | % | 100 | % | |||||
June 30, | September 30, | |||||||||||
2014 | 2013 | |||||||||||
Accounts receivable | ||||||||||||
The Medicines Company | 84 | % | 58 | % | ||||||||
Sandoz, Inc. | 15 | % | 40 | % | ||||||||
Other | 1 | % | 2 | % | ||||||||
100 | % | 100 | % | |||||||||
Currently, for argatroban, the Company uses one vendor as its sole source of supplier. Because of the unique equipment and process for manufacturing argatroban, transferring manufacturing activities for argatroban to an alternate supplier would be a time- consuming and costly endeavor, and there are only a limited number of manufacturers that are capable of performing this function for the Company. | ||||||||||||
Pre-Launch Inventory | ||||||||||||
The Company capitalizes inventory costs associated with certain products prior to regulatory approval and product launch, based on management's judgment of reasonably certain future commercial use and net realizable value, when it is reasonably certain that the pre-launch inventories will be saleable. The determination to capitalize is made once the Company (or its third party development partners) has filed an Abbreviated New Drug Application (an "ANDA") that has been acknowledged by the FDA as containing sufficient information to allow the FDA to conduct its review in an efficient and timely manner and management is reasonably certain that all regulatory and legal hurdles will be cleared. This determination is based on the particular facts and circumstances relating to the expected FDA approval of the drug product being considered, and accordingly, the time frame within which the determination is made varies from product to product. The Company could be required to write down previously capitalized costs related to pre-launch inventories upon a change in such judgment, or due to a denial or delay of approval by regulatory bodies, or a delay in commercialization, or other potential factors. As of June 30, 2014 the Company had $329,034 in inventories related to product that was not yet available to be sold. On July 22, 2014, the Company received FDA approval for the sale of the product. | ||||||||||||
Property and Equipment | ||||||||||||
Property and equipment are stated at cost. Depreciation is computed over the estimated useful lives of the assets utilizing the straight-line method. Leasehold improvements are being amortized over the shorter of their useful lives or the lease term. | ||||||||||||
Research and Development Expense | ||||||||||||
Costs incurred for research and product development, including costs incurred for technology in the development stage, are expensed as incurred. | ||||||||||||
Deferred Financing Costs | ||||||||||||
Prior to the initial public offering, costs relating to obtaining Convertible Notes were capitalized and amortized over the term of the related debt using the straight line method. Amortization of deferred financing costs charged to interest expense was $0, $38,567, $0 and $96,416 for the three and nine months ended June 30, 2014 and 2013, respectively. The unamortized balance as of June 30, 2014 and September 30, 2013 is $0. | ||||||||||||
Deferred Initial Public Offering Costs | ||||||||||||
Costs incurred of $2,073,694 related to the initial public offering, consisting primarily of professional fees, were deferred until the completion of the offering at which time such costs, as well as underwriters' fees paid, were netted against proceeds received and reclassified to Additional paid-in capital. | ||||||||||||
Advertising and Marketing | ||||||||||||
Advertising and marketing costs are expensed as incurred. Advertising and marketing costs were $596,024, $0, $685,937 and $117,977 for the three and nine months ended June 30, 2014 and 2013, respectively. | ||||||||||||
Redeemable Convertible Preferred Stock | ||||||||||||
The carrying value of redeemable convertible preferred stock was increased by periodic accretions, using the interest method so that the carrying amount would equal the redemption amount at the earliest redemption date. | ||||||||||||
Accounting for Income Taxes | ||||||||||||
The Company accounts for deferred taxes using the asset and liability method as specified by ASC 740, Income Taxes. Deferred income tax assets and liabilities are determined based on differences between the financial statement reporting and the tax basis of assets and liabilities, operating losses and tax credit carryforwards. Deferred income taxes are measured using the enacted tax rates and laws that are anticipated to be in effect when the differences are expected to reverse. The measurement of deferred income tax assets is reduced, if necessary, by a valuation allowance for any tax benefits which are not expected to be realized. The effect on deferred income tax assets and liabilities of a change in tax rates is recognized in the period that such tax rate changes are enacted. | ||||||||||||
The Company received approval to sell a portion of the Company's New Jersey net operating losses ("NOL's") as part of the Technology Business Tax Certificate Program sponsored by The New Jersey Economic Development Authority. Under the program, emerging biotechnology firms with unused net operating loss carryovers and unused research and development credits are allowed to sell these benefits to other firms. | ||||||||||||
During the nine months ended June 30, 2014 and 2013, the Company sold New Jersey state net operating loss (NJ NOL) carry forwards, which resulted in the recognition of $1,294,905 and $898,703 in tax benefits, respectively. | ||||||||||||
Revenue Recognition | ||||||||||||
Product Revenue — The Company recognizes net revenue from products manufactured and supplied to its commercial partners, when the following four basic revenue recognition criteria under the related accounting guidance are met: (1) persuasive evidence of an arrangement exists; (2) delivery has occurred or services have been rendered; (3) the fee is fixed or determinable; and (4) collectability is reasonably assured. Prior to the shipment of manufactured products, the Company conducts initial product release and stability testing in accordance with cGMP. The Company's commercial partners can return the products within contracted specified timeframes if the products do not meet the applicable inspection tests. The Company estimates its return reserves based on its experience with historical return rates. Historically, product returns have not been material. | ||||||||||||
Royalties — The Company recognizes revenue from royalties based on its commercial partners' net sales of products. Royalties are recognized as earned in accordance with contract terms when they can be reasonably estimated and collectability is reasonably assured. The Company's commercial partners are obligated to report their net product sales and the resulting royalty due to the Company within 60 days from the end of each quarter. Based on historical product sales, royalty receipts and other relevant information, the Company accrues royalty revenue each quarter and subsequently determines a true-up when it receives royalty reports from its commercial partners. Historically, these true-up adjustments have been immaterial. | ||||||||||||
Collaborative licensing and development revenue — The Company recognizes revenue from reimbursements received in connection with feasibility studies and development work for third parties when its contractual services are performed, provided collectability is reasonably assured. Its principal costs under these agreements include its personnel conducting research and development, and its allocated overhead, as the well as research and development performed by outside contractors or consultants. | ||||||||||||
The Company recognizes revenues from non-refundable up-front license fees received under collaboration agreements ratably over the performance period as determined under the collaboration agreement (estimated development period in the case of development agreements, and contract period or longest patent life in the case of supply and distribution agreements). If the estimated performance period is subsequently modified, the Company will modify the period over which the upfront license fee is recognized accordingly on a prospective basis. Upon termination of a collaboration agreement, any remaining non-refundable license fees received by the Company, which had been deferred, are generally recognized in full. All such recognized revenues are included in collaborative licensing and development revenue in its statements of operations. The Company recognizes revenue from milestone payments received under collaboration agreements when earned, provided that the milestone event is substantive, its achievability was not reasonably assured at the inception of the agreement, the Company has no further performance obligations relating to the event, and collectability is reasonably assured. If these criteria are not met, the Company recognizes milestone payments ratably over the remaining period of its performance obligations under the collaboration agreement. No such revenue was recorded in 2014 or 2013. | ||||||||||||
See Note 10 regarding Asset Sales related to Other Income of $3,500,000 recognized in June 2014. | ||||||||||||
Stock-Based Compensation | ||||||||||||
The Company accounts for stock-based compensation using the fair value provisions of ASC 718, Compensation — Stock Compensation that requires the recognition of compensation expense, using a fair-value based method, for costs related to all stock-based payments including stock options and restricted stock. This topic requires companies to estimate the fair value of the stock-based awards on the date of grant for options issued to employees and directors. The Company uses a Black-Scholes valuation model as the most appropriate valuation method for pricing these options. Awards for consultants are accounted for under ASC 505-50, Equity Based Payments to Non-Employees. Any compensation expense related to consultants is marked-to-market over the applicable vesting period as they vest. There are customary limitations on the sale or transfer of the stock. | ||||||||||||
The fair value of stock options granted to employees, directors, and consultants is estimated using the following assumptions: | ||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||
June 30, | June 30, | |||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||
Risk-free interest rate | 2.11% - 2.16% | .82% - 3.23% | 1.77% - 2.16% | .95% - 2.47% | ||||||||
Volatility | 56.84% | 64.00% | 64.00% | 36.58% - 39.65% | ||||||||
Expected term (in years) | 6.59 - 10.00 years | 6.08 - 10.00 years | 6.07 - 10.00 years | 6.08 - 9.81 years | ||||||||
Expected dividend yield | 0.00% | 0.00% | 0.00% | 0.00% | ||||||||
The risk-free rate assumption was based on U.S. Treasury instruments whose term was consistent with the expected term of the stock options. The expected stock price volatility was determined by examining the historical volatilities for industry peers as the Company did not have any trading history for its common stock. Industry peers consist of those companies in the pharmaceutical industry similar in size, stage of life-cycle and financial leverage. The expected term of stock options represents the average of the vesting period and the contractual life of the option for employees and the life of the option for consultants. The expected dividend assumption is based on the Company's history and expectation of future dividend payouts. Changes in the estimated forfeiture rates are reflected prospectively. | ||||||||||||
Net Loss Per Share | ||||||||||||
Basic loss per common share is computed based on the weighted average number of shares outstanding during the period. Diluted loss per share is computed in a manner similar to the basic loss per share, except that the weighted-average number of shares outstanding is increased to include all common shares, including those with the potential to be issued by virtue of warrants, options, convertible debt and other such convertible instruments. Diluted earnings per share contemplate a complete conversion to common shares of all convertible instruments only if they are dilutive in nature with regards to earnings per share. Since the Company has incurred net losses for all periods, basic loss per share and diluted loss per share are the same. | ||||||||||||
The anti-dilutive common shares equivalents outstanding at the three and nine months ended June 30, 2014 and 2013 were as follows: | ||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||
June 30, | June 30, | |||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||
Series A | — | 2,332,059 | 1,104,226 | 2,332,059 | ||||||||
Series B | — | 1,980,429 | 937,730 | 1,980,429 | ||||||||
Series B-1 | — | 1,455,750 | 689,295 | 1,455,750 | ||||||||
Series C | — | 1,719,690 | 814,270 | 1,719,690 | ||||||||
Series C warrants | — | 147,254 | 69,725 | 147,254 | ||||||||
Options | 990,330 | 705,655 | 891,393 | 850,749 | ||||||||
Total | 990,330 | 8,340,837 | 4,506,639 | 8,485,931 | ||||||||
Inventories
Inventories | 9 Months Ended | |||||||
Jun. 30, 2014 | ||||||||
Inventory Disclosure [Abstract] | ' | |||||||
Inventories | ' | |||||||
Inventories | ||||||||
Inventories consist of the following at June 30, 2014 and September 30, 2013: | ||||||||
June 30, | September 30, | |||||||
2014 | 2013 | |||||||
Raw material- pre launch inventory | $ | 329,034 | $ | — | ||||
$ | 329,034 | $ | — | |||||
Balance_Sheet_Accounts
Balance Sheet Accounts | 9 Months Ended | |||||||
Jun. 30, 2014 | ||||||||
Balance Sheet Related Disclosures [Abstract] | ' | |||||||
Balance Sheet Accounts | ' | |||||||
Balance Sheet Accounts | ||||||||
Prepaid and Other Current Assets | ||||||||
Prepaid and other current assets consist of the following: | ||||||||
June 30, | September 30, | |||||||
2014 | 2013 | |||||||
Prepaid expenses and other current assets | ||||||||
Prepaid Product Costs | $ | — | $ | 730,003 | ||||
Prepaid FDA User Fee | — | 1,023,291 | ||||||
Prepaid Insurance | 514,141 | 117,510 | ||||||
All Other | 408,789 | 31,856 | ||||||
Total Prepaid expenses and other current assets | $ | 922,930 | $ | 1,902,660 | ||||
Accrued Expenses | ||||||||
Accrued expenses consist of the following: | ||||||||
June 30, | September 30, | |||||||
2014 | 2013 | |||||||
Accrued expenses | ||||||||
Royalties Due to The Medicines Company | $ | 4,301,683 | $ | 1,724,061 | ||||
Royalties Due to SciDose | 859,868 | 546,756 | ||||||
Accrued Research & Development | 815,057 | 282,682 | ||||||
Accrued Professional Fees | 419,242 | 274,566 | ||||||
Accrued Salary | 244,158 | 169,568 | ||||||
Accrued Product Costs | 4,000 | 62,737 | ||||||
All Other | 824,786 | 69,182 | ||||||
Total Accrued expenses | $ | 7,468,794 | $ | 3,129,552 | ||||
Deferred Revenue | ||||||||
Deferred revenue consists of the following: | ||||||||
June 30, | September 30, | |||||||
2014 | 2013 | |||||||
Deferred revenue | ||||||||
The Medicines Company | $ | 259,653 | $ | 519,653 | ||||
Deferred Revenue for ongoing business | 259,653 | 519,653 | ||||||
Hikma Pharmaceuticals, Co. Ltd. (See Note 10) | — | 3,500,000 | ||||||
Par Pharmaceuticals Companies, Inc. | 5,500,000 | 5,500,000 | ||||||
Par Pharmaceuticals Companies, Inc./Tech Transfer | 500,000 | 500,000 | ||||||
Deferred Revenue from Asset Sales (See Note 10) | 6,000,000 | 9,500,000 | ||||||
Total Deferred revenue | $ | 6,259,653 | $ | 10,019,653 | ||||
Notes_Payable
Notes Payable | 9 Months Ended | |
Jun. 30, 2014 | ||
Debt Disclosure [Abstract] | ' | |
Notes Payable | ' | |
Notes Payable | ||
Convertible Notes | ||
The Company entered into a Convertible Note and Warrant Purchase Agreement (the "Convertible Note Agreements"), pursuant to which it issued $9,662,755 of Convertible Notes (the "Convertible Notes") to existing preferred stockholders. The loan funding was completed in two tranches on August 2, 2012 and September 26, 2012, respectively. Holders of the Convertible Notes were entitled to cumulative interest at an annual rate of 6%. Such interest accrued daily and was cumulative from the respective date. In addition, the holders received warrants to purchase preferred stock, which accrued at a monthly rate of 2% of the principal amount until the completion of a Qualified Financing, as defined in the Convertible Note Agreement, or August 1, 2013, whichever was sooner. | ||
The Convertible Notes and associated accrued interest were due and payable on August 1, 2013, unless the Convertible Notes converted earlier. Conversion could occur, upon certain triggering events or the holder elects to convert. Principal and interest accrued shall convert into shares of preferred stock: a) upon the attainment of a Qualified Financing, or b) on August 1, 2013, whichever is sooner. Upon conversion pursuant to (a), the aggregate amount converted will be divided by the offering price of the Qualified Financing to arrive at the amount of preferred stock that will be issued. Upon conversion pursuant to (b), the aggregate amount converted will be divided by $1.82 to arrive at the amount of preferred stock that will be issued. | ||
The Series C Preferred Share financing (See Note 6) represented a Qualified Financing whereby the Convertible Notes for those participating investors converted to Series C Preferred Shares. | ||
The Convertible Notes agreement was structured such that a portion of the shares of the Company's Series A preferred stock, Series B preferred stock and Series B-1 preferred stock, collectively the "Special Conversion Preferred", held by a holder, that did not participate in the financing to the full extent of its pro rata share of preferred stock ownership (a "Non-Fully Participating Holder"), was converted into shares of the Company's Common Stock, and any dividends accumulated to date were forfeited. | ||
The option for existing preferred stockholders to participate in the Convertible Notes expired on October 1, 2012. On October 2, 2012, 8,943,447 shares of preferred stock held by Non-Fully Participating Holders were converted into 1,395,226 shares of Common Stock. | ||
Warrants | ||
Prior to the initial public offering, the Company accounted for the warrants as liability instruments. The Company estimated the initial fair value of the 944,210 warrants to be $654,527 using a Probability-Weighted Expected Returns valuation model. At each reporting period, any changes to the fair value of the warrants were recorded in the statements of operations. As of June 30, 2014 and September 30, 2013, warrants to purchase 0 and 944,210 shares of common stock, respectively, were outstanding in connection with the warrants. | ||
The valuation model considered three scenarios. Two of the scenarios assumed a stockholder exit, either through sale, or dissolution. The third scenario assumed operations continue as a private company and no exit transaction occurred. The following assumptions were used in the valuation: exercise price of $1.82; implied stock price of $1.82; expected volatility of 64%; expected dividend rate of 6%; risk free interest rate of 0.83% and expiration date of six years. | ||
The following was a description of the key terms of the warrants per the warrant purchase agreement: | ||
• | Exercise period — Exercisable, in whole or in part, during the six year term commencing on the earliest to occur of: (a) the consummation of a Qualified Financing, (b) immediately prior to the consummation of a Change of Control (but subject to and contingent upon such consummation of a Change of Control) and (c) the date one year after the Initial Closing or August 1, 2013. | |
• | Exercise Price — The purchase price for the Warrant Shares issuable was: (a) $1.82, or (b) the offering price of a Qualified Financing should this occur prior to August 1, 2013. | |
• | No Rights as Stockholders — Prior to the exercise of the warrants, no holder of warrants (solely in its capacity as a holder of warrants) is entitled to any rights as a stockholder of the Company, including, without limitation, the right to vote, receive notice of any meeting of stockholders or receive dividends, allotments or other distributions. | |
In February 2014, proceeds in the amount of $20,868 were received from the exercise of Series C preferred stock warrants for 1,788 common shares. In addition, Redeemable Series C preferred stock warrants were net exercised for 32,286 shares common stock upon the closing of the initial public offering. | ||
Warrant Liability | ||
On February 18, 2014, the initial public offering date, the estimated fair value of the Convertible Note warrant liability was $2,280,378 which resulted in a charge to other income and expense of $382,630. The change in the value of the warrant liability was $0, $15,608, $573,582, and $15,608 for the three and nine months ended June 30, 2014 and 2013, respectively. As of September 30, 2013, the estimated fair value of the Convertible Note warrant liability was $1,706,829 which resulted in a charge to other income and expense of $1,052,302 for the year ended September 30, 2013. Upon the completion of the qualified offering, the warrants became exercisable into Series C Preferred Shares. The increase in the fair value of the warrant liability is primarily attributable to the liquidation preference of the Series C Preferred Shares to receive 2 times the original investment upon a liquidation event under certain circumstances. | ||
Debt Discount | ||
In connection with the Convertible Notes described above and as a result of the warrants issued with the Convertible Notes, the Company determined that a discount to the debt should be recorded in the amount of $654,528, representing its fair value and recorded as a discount to the debt instrument and amortized over the life of the instrument. The amount recorded as interest expense during the three and nine months ended June 30, 2014 and 2013 was approximately $0, $218,000, $0, and $545,000, respectively. Due to the conversion of the Convertible Notes to preferred stock, the balance of the unamortized debt discount was written off during the year ended September 30, 2013, resulting in interest expense of $545,000. | ||
Beneficial Conversion Feature | ||
A convertible financial instrument includes a beneficial conversion feature if the effective conversion price is less than the Company's market price of preferred stock on the commitment date. The effective price paid for a share is the amount allocated to the convertible instrument, divided by the number of shares the holder is entitled to upon conversion. If the convertible financial instrument is issued with warrants and/or other detachable instruments, the amount allocated to the convertible instrument is the face amount less the allocation to the detachable instruments. | ||
In connection with the Convertible Notes described above and as a result of the warrants issued with the Convertible Notes, the Company determined that the conversion rate represented a beneficial conversion feature. Accordingly, a discount on the notes was recorded in the amount of $654,528. The discount was amortized ratably with a corresponding non-cash charge to interest expense. The amount recorded as interest expense during the three and nine months ended June 30, 2014 and 2013 was approximately$0, $218,000, $0, and $545,000, respectively. Due to the conversion of the Convertible Notes to preferred stock, the balance of the unamortized beneficial conversion feature was written off during the year ended September 30, 2013, resulting in interest expense of $545,000. |
Shares_Subject_to_Redemption_C
Shares Subject to Redemption b Convertible Preferred Stock | 9 Months Ended |
Jun. 30, 2014 | |
Financial Instruments Subject to Mandatory Redemption, Settlement Terms, Share Value, Amount [Abstract] | ' |
Shares Subject to Redemption - Convertible Preferred Stock | ' |
Shares Subject to Redemption — Convertible Preferred Stock | |
Series A Convertible preferred stock | |
On March 8, 2007, the Company issued 20,237,911 shares of Series A Convertible preferred stock, par value $0.001 (the "Series A preferred stock"). The outstanding shares of the Series A preferred stock (as amended in connection with the issuance of the Series B preferred stock) is redeemable after August 11, 2013 at a redemption price per share equal to the Original Issue Price of $0.971 per share plus accrued but unpaid dividends (see "Redemption" below). The outstanding Series A convertible preferred stock converted into 2,332,051 shares of common stock upon the closing of the initial public offering. The outstanding shares of the Series A preferred stock were recorded at their estimated fair value of $19,651,000 which equaled the sale price on the date of issuance. The amount was adjusted for net offering costs of $179,806. The fair value of the Series A preferred stock had been increased through periodic accretions using the interest method for dividends (see "Preferred Stock Dividends" below) so that the carrying value equals the redemption amount on the redemption date. Accumulated dividends on the Series A preferred stock as of June 30, 2014 and September 30, 2013 were $0 and $5,721,608 respectively. The liquidation value of the Series A preferred stock was $0 and $20,236,596 as of June 30, 2014 and September 30, 2013, respectively. The accumulated dividend through the closing date of the initial public offering on February 18, 2014 of the Series A preferred stock was $97,261. | |
Series B Convertible Preferred Stock | |
On August 11, 2008, the Company issued 16,052,343 shares of Series B Convertible preferred stock, par value $0.001 (the "Series B preferred stock"). The Series B preferred stock is redeemable as described above for the Series A preferred stock at a redemption price per share equal to the Original Issue Price of $1.82 per share plus accrued but unpaid dividends (see "Redemption" below). The outstanding Series B convertible preferred stock converted into 1,980,431 shares of common stock upon the closing of the initial public offering. The outstanding shares of the Series B preferred stock were recorded at their estimated fair value of $29,215,266, which equaled the sale price on the date of issuance. The amount was adjusted for net offering costs of $125,714. The fair value of the Series B preferred stock had been increased through periodic accretions using the interest method so that the carrying value equals the redemption amount on the redemption date. Accumulated dividends on redeemable shares as of June 30, 2014, and September 30, 2013 were $0 and $7,111,465, respectively. The liquidation value of the Series B preferred stock is $0 and $30,215,567 as of June 30, 2014 and September 30, 2013, respectively. The accumulated dividend through the closing date of the initial public offering on February 18, 2014 was $172,971. | |
Series B-1 Convertible Preferred Stock | |
The Company consummated an offering of Series B-1 Convertible preferred stock, par value $0.001 (the "Series B-1 Preferred Stock") to its existing investors in two stages in February 2011 and July 2011. The Company issued an aggregate of 10,177,085 shares of Series B-1 preferred stock. The Series B-1 preferred stock is redeemable at a redemption price per share equal to the Original Issue Price of $1.82 per share plus accrued but unpaid dividends (see "Redemption" below). The outstanding series B-1 convertible preferred stock converted into 1,455,753 shares of common stock upon the closing of the initial public offering. The outstanding shares of the Series B-1 preferred stock were recorded at their estimated fair value of $17,522,294 which equaled the sale price on the date of issuance. The amount was adjusted for net offering costs of $144,250. On August 2, 2012, the Company entered into a Payoff and Exchange Agreement with an Officer/Director. The Company accepted a total of 549,451 shares of Series B-1 preferred stock in exchange for satisfaction of the principal amount of debt. The total number of outstanding shares of Series B-1 preferred stock was 9,627,634 as of September 30, 2012. The fair value of the Series B preferred stock had been increased through periodic accretions using the interest method so that the carrying value equals the redemption amount on the redemption date. Accumulated dividends on redeemable shares were $0 and $2,535,434 as of June 30, 2014 and September 30, 2013, respectively. The liquidation value of the Series B-1 preferred stock is $0 and $19,518,535 as of June 30, 2014 and September 30, 2013, respectively. The accumulated dividend through the closing date of the initial public offering on February 18, 2014 of the Series B-1 preferred stock was $125,096. | |
Series C Convertible Preferred Stock | |
The Company consummated an offering of Series C Convertible preferred stock, par value $0.001 (the "Series C preferred stock") on April 11, 2013. The Company issued an aggregate of 11,023,232 shares of Series C preferred stock. The Series C preferred stock is redeemable at a redemption price per share equal to the Original Issue Price of $1.82 per share plus accrued but unpaid dividends (see "Redemption" below). The outstanding series C convertible preferred stock converted into 1,719,693 shares of common stock upon the closing of the initial public offering. The outstanding shares of the Series C preferred stock were recorded at their estimated fair value of $20,062,296 which equaled the sale price on the date of issuance. The amount was adjusted for net offering costs of $167,465. The fair value of the Series C preferred stock had been increased through periodic accretions using the interest method so that the carrying value equals the redemption amount on the redemption date. Accumulated dividends on redeemable shares were $0 and $567,241 as of June 30, 2014 and September 30, 2013, respectively. The liquidation value of the Series C preferred stock is $0 and $20,629,537 as of June 30, 2014 and September 30, 2013, respectively. The accumulated dividend through closing date of the initial public offering on February 18, 2014 of the Series C preferred stock was $138,513. | |
On October 2, 2012, holders of preferred stock who elected not to participate in the Convertible Notes (see "Notes Payable") had their preferred stock shares convert to Common stock. Upon conversion from preferred to common, the investors forfeited all accumulated dividends from their investment date. 5,289,405 shares of Series A preferred stock were converted into 825,177 shares of Common stock and $1,718,102 in accumulated dividends was forfeited, 3,357,782 shares of Series B preferred stock were converted into 532,832 shares of Common Stock and $1,519,922 in accumulated dividends was forfeited, and 296,260 shares of Series B-1 preferred stock were converted into 46,218 shares of Common stock and $48,572 in accumulated dividends was forfeited. Concurrent with the conversion, the Company reduced the amounts authorized for the Series A, Series B, and Series B-1 preferred stock to 14,948,506 shares, 12,694,561 shares and 9,331,374 shares, respectively. |
Common_Stock_and_StockBased_Co
Common Stock and Stock-Based Compensation | 9 Months Ended | |||||||||||||||
Jun. 30, 2014 | ||||||||||||||||
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ' | |||||||||||||||
Common Stock and Stock-Based Compensation | ' | |||||||||||||||
Common Stock and Stock-Based Compensation | ||||||||||||||||
In December 2007, the Company's Board of Directors approved the 2007 Incentive Compensation Plan (the "2007 Plan") enabling the Company to grant multiple stock based awards to employees, directors and consultants, the most common being stock options and restricted stock awards. In November 2013, the Company's Board of Directors approved the 2014 Equity Incentive Plan (the "2014 Plan") which became effective on February 11, 2014. The 2007 Plan was terminated upon the effectiveness of the 2014 Plan and all shares available for issuance under the 2007 Plan were made available under the 2014 Plan. The 2014 Plan provides for the awards of incentive stock options, non-qualified stock options, restricted stock, restricted stock units and other stock-based awards. Awards generally vest equally over a period of four years from grant date. Vesting is accelerated under a change in control of the Company or in the event of death or disability to the recipient. In the event of termination, any unvested shares or options are forfeited. The Company has reserved and made available 974,311 shares of common stock for issuance under the 2014 Plan. | ||||||||||||||||
The Company recognized share-based compensation in its statements of operations for the three and nine months ended June 30, 2014 and 2013 as follows: | ||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||||
Selling, general and administrative | $ | 77,628 | $ | 84,583 | $ | 190,878 | $ | 252,626 | ||||||||
Research and development | 85,872 | 43,730 | 190,858 | 77,293 | ||||||||||||
Total | $ | 163,500 | $ | 128,313 | $ | 381,736 | $ | 329,919 | ||||||||
License_Agreements_of_Developm
License Agreements of Development and Commercialization Rights | 9 Months Ended |
Jun. 30, 2014 | |
Research and Development [Abstract] | ' |
License Agreements of Development and Commercialization Rights | ' |
License Agreements of Development and Commercialization Rights | |
Development | |
The Company has entered into several product development agreements with development partners whereby the Company acquired the exclusive rights in the United States and, in most cases, worldwide rights to a total of thirty-three products for ten years following first commercial sale of each product. The Company will share varying percentages of the profits after, in most cases, recapturing development, legal and certain operating costs, from the sales of the products with the development partners if the products are commercialized. The Company expenses these costs as incurred. | |
Commercialization Rights | |
In May 2008, the Company entered into a collaborative product development agreement with a Branded product company, whereby the Company has agreed to develop a product for the Brand Company. Under the terms of the agreement, the Brand Company acquired the exclusive worldwide rights to market the product for ten years following approval. The Company will receive a royalty on net sales of the product, dependent upon the achievement of certain goals. In addition, the Company received $750,000 upon signing which was non-refundable and recorded as revenue in the year it was received and it will receive milestones of up to $13,000,000 upon the achievement of certain goals. The Brand Company is also required to pay all out of pocket costs related to the project and also made payments to the Company totaling $2,000,000 for the development of the product, payable at $200,000 per month commencing in April 2008. In July 2013, an arbitration settlement between the two companies was reached. The Company then terminated the contract; therefore no additional revenues will be recognized. |
Asset_Sales
Asset Sales | 9 Months Ended |
Jun. 30, 2014 | |
Deferred Revenue Disclosure [Abstract] | ' |
Asset Sales | ' |
Asset Sales | |
On March 28, 2012, the Company entered into an Asset Purchase Agreement (“APA”) with Hikma Pharmaceutical Co. LTD, or Hikma. Under the terms of the agreement, Hikma acquired exclusive U.S. rights to market diclofenac/misoprostol following regulatory approval. The Company received $3,500,000 upon signing the APA. This amount was included in deferred revenue until FDA approval, since it was otherwise refundable. In addition, the Company was entitled to receive another $1,000,000 upon regulatory approval, validation batch manufacturing with inventory released for launch, and sufficient launch inventory. Before approval, this approval milestone was to be reduced for each generic competitor that received regulatory approval (excluding an "authorized generic" version of the Brand Product); however, the milestone was not to be reduced to an amount less than $500,000. The Company was to receive a royalty on Net Profits of the product for a period of ten years from the date of the first commercial sale of the product, with the royalty percentage varying depending upon certain events and competition. | |
On June 24, 2013, Hikma filed a lawsuit against the Company in the United States District Court for the Southern District of New York alleging that the Company (a) breached the Hikma, APA by failing to refund the purchase price following Hikma's purported termination of the Hikma APA as a result of the Company failing to receive timely ANDA approval, and (b) intentionally failed to disclose alleged manufacturing product defects to Hikma. The Company believed that it did not fail to receive timely ANDA approval and therefore that Hikma was not entitled to (a) terminate the Hikma APA or (b) receive a refund of the purchase price. The Company also believed that it did not intentionally fail to disclose alleged manufacturing product defects to Hikma. If Hikma had prevailed on its claims, the Company could have been required to return the $3,500,000 purchase price plus interest, as well as other damages. The Company could not estimate the possible loss or range of loss related to the Hikma litigation beyond the $3,500,000 purchase price. | |
On March 14, 2014, the Company received FDA approval of our Abbreviated New Drug Application for diclofenac/misoprostol tablets. The Company had not yet recognized the $3,500,000 as revenue since it was required to submit additional data to the FDA. In May 2014, under a CBE-30 supplement, the Company submitted additional data to the FDA with respect to manufacturing procedures of the product and achieved final approval in June 2014. | |
As of June 30, 2014, the Company has recognized the $3,500,000 purchase price as revenue in Other income in the current period as it had received FDA approval and subsequently complied with all FDA requirements. Pursuant to the in-license agreement for diclofenac/misoprostol, the Company estimated amounts due to the licensor. | |
During fiscal year 2010 and 2011, the Company divested another non-core product and received proceeds of $6,500,000, comprised of $5,500,000 as a signing milestone which is recorded in deferred revenues and $500,000 for the initiation of Tech Transfer of which $250,000 remains in deferred revenues and a second payment of $500,000 for the completion of the Tech Transfer of which $250,000 remains in deferred revenues. Under the terms of this agreement, the licensor must obtain all of the following milestones in order for the Company to earn the revenues. These milestones are a) the receipt of an approvable letter from the FDA, b) acknowledgment from the FDA that no further clinical studies will be needed and c) an approval letter from the FDA. If these milestones are not met, then the $6,000,000 in total included in deferred revenue on the balance sheet at June 30, 2014 and September 30, 2013 must be refunded and the product rights are returned to the Company. In addition, the Company may receive additional milestones of up to $3,000,000 in the future, dependent on the licensor's actively selling the product in an exclusive market position. | |
See Note 5 for a summary of Deferred Revenue related to the Asset Sales. |
Commitments
Commitments | 9 Months Ended |
Jun. 30, 2014 | |
Commitments and Contingencies Disclosure [Abstract] | ' |
Commitments | ' |
Commitments | |
At June 30, 2014, the Company has purchase obligations in the amount of $751,000 which represent the contractual commitments under a Contract Manufacturing and Supply Agreement with a supplier. The obligation under the supply agreement is primarily for finished product and research and development. | |
The Company leases its office space under a lease agreement that expires on May 31, 2015. Rental expense was $68,104, $63,873, $208,457 and $270,482 for the three and nine months ended June 30, 2014 and 2013, respectively. The remaining future lease payments under the operating lease are $249,714 as of June 30, 2014, payable monthly through May 31, 2015. |
Arbitration
Arbitration | 9 Months Ended |
Jun. 30, 2014 | |
Commitments and Contingencies Disclosure [Abstract] | ' |
Arbitration | ' |
Arbitration | |
On October 26, 2011, the Company filed a Demand for Arbitration with the American Arbitration Association against a commercial partner that licensed one of its products. Eagle's claims include breach of contract relating to the development of a new formulation of the product and lack of effort to seek and obtain regulatory approval, ultimately impacting the marketing and sale of that new formulation. As a result, Eagle alleged that it had been significantly damaged. A three person arbitration panel was appointed. The trial was completed on January 25, 2013. | |
In April 2013, the Company successfully renegotiated the terms of our legal fees to a contingent settlement as opposed to an hourly billing rate. As a result of the renegotiated terms, the Company recognized a $1,993,099 benefit. | |
On July 19, 2013, the American Arbitration Association panel awarded the Company $5,000,000 for damages plus $23,900 for apportioned costs related to the arbitration for breach of contract. The Company received the funds in September 2013 and the amount was recorded in the results of operations, net of expenses of $973,649 in the fourth quarter of fiscal year 2013. |
Legal_Proceedings
Legal Proceedings | 9 Months Ended |
Jun. 30, 2014 | |
Commitments and Contingencies Disclosure [Abstract] | ' |
Legal Proceedings | ' |
Legal Proceedings | |
Claims and lawsuits may be filed against the Company from time to time. Although the results of pending claims are always uncertain, the Company believes that it has adequate reserves or adequate insurance coverage in respect of these claims, but no assurance can be given as to the sufficiency of such reserves or insurance coverage in the event of any unfavorable outcome resulting from such actions. | |
See Notes 10 and 14 for a summary of legal proceedings with Hikma. | |
In September 2013, the Company filed a New Drug Application under Section 505(b)(2) for EP-3101 (bendamustine RTD) and notified Teva Pharmaceuticals, the holder of Treanda, the referenced approved drug in our application, of the Company's 505(b)(2) filing and paragraph IV certification. Teva filed a patent infringement lawsuit against the Company in the United States District Court for the District of Delaware on October 21, 2013 to defer the approval of the bendamustine indication. Teva's filing of the lawsuit invoked a 30-month stay of FDA approval of the Company's bendamustine product, which will delay FDA approval until the earlier of the March 2016 expiration of the 30-month stay imposed by the Hatch-Waxman Act, or such time as the district court enters judgment in the Company's favor or otherwise acts to shorten the stay. Moreover, regardless of when the 30-month stay is resolved or expires, the FDA may still be prohibited from approving the Company's 505(b)(2) NDA due to Teva's unexpired orphan drug and pediatric exclusivities for Treanda. Specifically, Teva has received orphan drug and related pediatric exclusivity expiring in September 2015 and May 2016 for the Chronic Lymphocytic Leukemia ("CLL") and indolent B-cell non-Hodgkin's Lymphoma ("NHL") indications, respectively. When a drug, such as Treanda, has orphan drug exclusivity, the FDA may not approve any other application to market the same drug for the same indication for a period of up to seven years, except in limited circumstances, such as a showing of clinical superiority over the product with orphan exclusivity. In the United States, pediatric exclusivity adds six months to any existing exclusivity period. If the Company cannot demonstrate that EP-3101 is clinically superior to Treanda, or qualify under certain other limited exceptions, the Company will not be able to enter the market for the CLL indication until September 2015 (assuming the 30-month stay is resolved by that time) or the NHL indication until May 2016. | |
In July 2014, the FDA had granted tentative approval and orphan drug designation to the Company’s New Drug Application (the "NDA") for patented Bendamustine Hydrochloride Injection, a ready-to-dilute concentrate solution (“bendamustine RTD”) for the treatment of NHL. |
Subsequent_Events
Subsequent Events | 9 Months Ended |
Jun. 30, 2014 | |
Subsequent Events [Abstract] | ' |
Subsequent Events | ' |
14. Subsequent Events | |
On August 8, 2014, the Company settled the lawsuit with Hikma related to the APA (See Note 10 “Asset Sales”). Pursuant to the terms of the settlement the Company will retain ownership of diclofenac/misoprostol including the rights to launch and commercialize the Product, and the Company will pay to Hikma a percentage of Net Profits after recovery of certain of the Company's expenses. |
Summary_of_Significant_Account1
Summary of Significant Accounting Policies (Policies) | 9 Months Ended | |||||||
Jun. 30, 2014 | ||||||||
Accounting Policies [Abstract] | ' | |||||||
Use of Estimates | ' | |||||||
Use of Estimates | ||||||||
The preparation of condensed financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed financial statements including disclosure of contingent assets and contingent liabilities at the date of the condensed financial statements and the reported amounts of revenues and expenses during the reporting period and accompanying notes. The Company's critical accounting policies are those that are both most important to the Company's financial condition and results of operations and require the most difficult, subjective or complex judgments on the part of management in their application, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. Because of the uncertainty of factors surrounding the estimates or judgments used in the preparation of the condensed financial statements, actual results may materially vary from these estimates. | ||||||||
Cash and Cash Equivalents | ' | |||||||
Cash and Cash Equivalents | ||||||||
The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents. All cash and cash equivalents are held in United States financial institutions. The carrying amount of cash and cash equivalents approximates its fair value due to its short-term nature. | ||||||||
The Company, at times, maintains balances with financial institutions in excess of the FDIC limit. | ||||||||
Fair Value of Financial Instruments | ' | |||||||
Fair Value of Financial Instruments | ||||||||
The Company's financial instruments consist of cash and cash equivalents, accounts receivable, and accounts payable. The carrying values of these financial instruments approximate their fair values due to their short term maturities. | ||||||||
Fair Value Measurements | ' | |||||||
Fair Value Measurements | ||||||||
U.S. GAAP establishes a framework for measuring fair value under generally accepted accounting principles and enhances disclosures about fair value measurements. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The standard describes the following fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value: | ||||||||
• | Level 1: Quoted prices in active markets for identical assets or liabilities. | |||||||
• | Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. | |||||||
• | Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. | |||||||
The fair value of interest-bearing cash and cash equivalents are classified as Level 1 at June 30, 2014 and September 30, 2013. | ||||||||
The Company is required by U.S. GAAP to record certain assets and liabilities at fair value on a recurring basis. | ||||||||
The guidance in ASC 815 required that the Company mark the value of its warrant liability (See Note 6) to market and recognize the change in valuation in its statement of operations each reporting period. Determining the warrant liability to be recorded required the Company to develop estimates to be used in calculating the fair value of the warrant. | ||||||||
Since these preferred stock warrants did not trade in an active securities market, the Company recognized a warrant liability and estimated the fair value of these warrants using a Probability-Weighted Expected Returns valuation model. Therefore, the warrant liability was considered a Level 3 measurement. | ||||||||
Concentration of Major Customers and Vendors | ' | |||||||
Concentration of Major Customers and Vendors | ||||||||
The Company's customers are its commercial and licensing partners. The Company is dependent on these commercial partners to market and sell argatroban, from which all of its current revenues are currently derived; therefore, the Company's future revenues are highly dependent on these collaboration and distribution arrangements. | ||||||||
Property and Equipment | ' | |||||||
Property and Equipment | ||||||||
Property and equipment are stated at cost. Depreciation is computed over the estimated useful lives of the assets utilizing the straight-line method. Leasehold improvements are being amortized over the shorter of their useful lives or the lease term. | ||||||||
Research and Development Expense | ' | |||||||
Research and Development Expense | ||||||||
Costs incurred for research and product development, including costs incurred for technology in the development stage, are expensed as incurred. | ||||||||
Deferred Financing Costs | ' | |||||||
Deferred Financing Costs | ||||||||
Prior to the initial public offering, costs relating to obtaining Convertible Notes were capitalized and amortized over the term of the related debt using the straight line method. | ||||||||
Deferred IPO Costs | ' | |||||||
Deferred Initial Public Offering Costs | ||||||||
Costs incurred of $2,073,694 related to the initial public offering, consisting primarily of professional fees, were deferred until the completion of the offering at which time such costs, as well as underwriters' fees paid, were netted against proceeds received and reclassified to Additional paid-in capital. | ||||||||
Advertising and Marketing | ' | |||||||
Advertising and Marketing | ||||||||
Advertising and marketing costs are expensed as incurred. | ||||||||
Redeemable Convertible Preferred Stock | ' | |||||||
Redeemable Convertible Preferred Stock | ||||||||
The carrying value of redeemable convertible preferred stock was increased by periodic accretions, using the interest method so that the carrying amount would equal the redemption amount at the earliest redemption date. | ||||||||
Accounting for Income Taxes | ' | |||||||
Accounting for Income Taxes | ||||||||
The Company accounts for deferred taxes using the asset and liability method as specified by ASC 740, Income Taxes. Deferred income tax assets and liabilities are determined based on differences between the financial statement reporting and the tax basis of assets and liabilities, operating losses and tax credit carryforwards. Deferred income taxes are measured using the enacted tax rates and laws that are anticipated to be in effect when the differences are expected to reverse. The measurement of deferred income tax assets is reduced, if necessary, by a valuation allowance for any tax benefits which are not expected to be realized. The effect on deferred income tax assets and liabilities of a change in tax rates is recognized in the period that such tax rate changes are enacted. | ||||||||
Revenue Recognition | ' | |||||||
Revenue Recognition | ||||||||
Product Revenue — The Company recognizes net revenue from products manufactured and supplied to its commercial partners, when the following four basic revenue recognition criteria under the related accounting guidance are met: (1) persuasive evidence of an arrangement exists; (2) delivery has occurred or services have been rendered; (3) the fee is fixed or determinable; and (4) collectability is reasonably assured. Prior to the shipment of manufactured products, the Company conducts initial product release and stability testing in accordance with cGMP. The Company's commercial partners can return the products within contracted specified timeframes if the products do not meet the applicable inspection tests. The Company estimates its return reserves based on its experience with historical return rates. Historically, product returns have not been material. | ||||||||
Royalties — The Company recognizes revenue from royalties based on its commercial partners' net sales of products. Royalties are recognized as earned in accordance with contract terms when they can be reasonably estimated and collectability is reasonably assured. The Company's commercial partners are obligated to report their net product sales and the resulting royalty due to the Company within 60 days from the end of each quarter. Based on historical product sales, royalty receipts and other relevant information, the Company accrues royalty revenue each quarter and subsequently determines a true-up when it receives royalty reports from its commercial partners. Historically, these true-up adjustments have been immaterial. | ||||||||
Collaborative licensing and development revenue — The Company recognizes revenue from reimbursements received in connection with feasibility studies and development work for third parties when its contractual services are performed, provided collectability is reasonably assured. Its principal costs under these agreements include its personnel conducting research and development, and its allocated overhead, as the well as research and development performed by outside contractors or consultants. | ||||||||
The Company recognizes revenues from non-refundable up-front license fees received under collaboration agreements ratably over the performance period as determined under the collaboration agreement (estimated development period in the case of development agreements, and contract period or longest patent life in the case of supply and distribution agreements). If the estimated performance period is subsequently modified, the Company will modify the period over which the upfront license fee is recognized accordingly on a prospective basis. Upon termination of a collaboration agreement, any remaining non-refundable license fees received by the Company, which had been deferred, are generally recognized in full. All such recognized revenues are included in collaborative licensing and development revenue in its statements of operations. The Company recognizes revenue from milestone payments received under collaboration agreements when earned, provided that the milestone event is substantive, its achievability was not reasonably assured at the inception of the agreement, the Company has no further performance obligations relating to the event, and collectability is reasonably assured. If these criteria are not met, the Company recognizes milestone payments ratably over the remaining period of its performance obligations under the collaboration agreement. | ||||||||
Stock-based Compensation | ' | |||||||
Stock-Based Compensation | ||||||||
The Company accounts for stock-based compensation using the fair value provisions of ASC 718, Compensation — Stock Compensation that requires the recognition of compensation expense, using a fair-value based method, for costs related to all stock-based payments including stock options and restricted stock. This topic requires companies to estimate the fair value of the stock-based awards on the date of grant for options issued to employees and directors. The Company uses a Black-Scholes valuation model as the most appropriate valuation method for pricing these options. Awards for consultants are accounted for under ASC 505-50, Equity Based Payments to Non-Employees. Any compensation expense related to consultants is marked-to-market over the applicable vesting period as they vest. There are customary limitations on the sale or transfer of the stock. | ||||||||
The fair value of stock options granted to employees, directors, and consultants is estimated using the following assumptions: | ||||||||
Three Months Ended | Nine Months Ended | |||||||
June 30, | June 30, | |||||||
2014 | 2013 | 2014 | 2013 | |||||
Risk-free interest rate | 2.11% - 2.16% | .82% - 3.23% | 1.77% - 2.16% | .95% - 2.47% | ||||
Volatility | 56.84% | 64.00% | 64.00% | 36.58% - 39.65% | ||||
Expected term (in years) | 6.59 - 10.00 years | 6.08 - 10.00 years | 6.07 - 10.00 years | 6.08 - 9.81 years | ||||
Expected dividend yield | 0.00% | 0.00% | 0.00% | 0.00% | ||||
The risk-free rate assumption was based on U.S. Treasury instruments whose term was consistent with the expected term of the stock options. The expected stock price volatility was determined by examining the historical volatilities for industry peers as the Company did not have any trading history for its common stock. Industry peers consist of those companies in the pharmaceutical industry similar in size, stage of life-cycle and financial leverage. The expected term of stock options represents the average of the vesting period and the contractual life of the option for employees and the life of the option for consultants. The expected dividend assumption is based on the Company's history and expectation of future dividend payouts. Changes in the estimated forfeiture rates are reflected prospectively. | ||||||||
Net Loss Per Share | ' | |||||||
Net Loss Per Share | ||||||||
Basic loss per common share is computed based on the weighted average number of shares outstanding during the period. Diluted loss per share is computed in a manner similar to the basic loss per share, except that the weighted-average number of shares outstanding is increased to include all common shares, including those with the potential to be issued by virtue of warrants, options, convertible debt and other such convertible instruments. Diluted earnings per share contemplate a complete conversion to common shares of all convertible instruments only if they are dilutive in nature with regards to earnings per share. |
Summary_of_Significant_Account2
Summary of Significant Accounting Policies (Tables) | 9 Months Ended | |||||||||||
Jun. 30, 2014 | ||||||||||||
Accounting Policies [Abstract] | ' | |||||||||||
Schedule of Revenue by Major Customers by Reporting Segments | ' | |||||||||||
The total revenues and accounts receivables broken down by major customers as a percentage of the total are as follows: | ||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||
June 30, | June 30, | |||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||
Net revenues | ||||||||||||
The Medicines Company | 51 | % | 42 | % | 42 | % | 53 | % | ||||
Sandoz, Inc. | 49 | % | 58 | % | 58 | % | 47 | % | ||||
100 | % | 100 | % | 100 | % | 100 | % | |||||
June 30, | September 30, | |||||||||||
2014 | 2013 | |||||||||||
Accounts receivable | ||||||||||||
The Medicines Company | 84 | % | 58 | % | ||||||||
Sandoz, Inc. | 15 | % | 40 | % | ||||||||
Other | 1 | % | 2 | % | ||||||||
100 | % | 100 | % | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | ' | |||||||||||
The fair value of stock options granted to employees, directors, and consultants is estimated using the following assumptions: | ||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||
June 30, | June 30, | |||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||
Risk-free interest rate | 2.11% - 2.16% | .82% - 3.23% | 1.77% - 2.16% | .95% - 2.47% | ||||||||
Volatility | 56.84% | 64.00% | 64.00% | 36.58% - 39.65% | ||||||||
Expected term (in years) | 6.59 - 10.00 years | 6.08 - 10.00 years | 6.07 - 10.00 years | 6.08 - 9.81 years | ||||||||
Expected dividend yield | 0.00% | 0.00% | 0.00% | 0.00% | ||||||||
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | ' | |||||||||||
The anti-dilutive common shares equivalents outstanding at the three and nine months ended June 30, 2014 and 2013 were as follows: | ||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||
June 30, | June 30, | |||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||
Series A | — | 2,332,059 | 1,104,226 | 2,332,059 | ||||||||
Series B | — | 1,980,429 | 937,730 | 1,980,429 | ||||||||
Series B-1 | — | 1,455,750 | 689,295 | 1,455,750 | ||||||||
Series C | — | 1,719,690 | 814,270 | 1,719,690 | ||||||||
Series C warrants | — | 147,254 | 69,725 | 147,254 | ||||||||
Options | 990,330 | 705,655 | 891,393 | 850,749 | ||||||||
Total | 990,330 | 8,340,837 | 4,506,639 | 8,485,931 | ||||||||
Inventories_Tables
Inventories (Tables) | 9 Months Ended | |||||||
Jun. 30, 2014 | ||||||||
Inventory Disclosure [Abstract] | ' | |||||||
Schedule of Inventory, Current | ' | |||||||
Inventories consist of the following at June 30, 2014 and September 30, 2013: | ||||||||
June 30, | September 30, | |||||||
2014 | 2013 | |||||||
Raw material- pre launch inventory | $ | 329,034 | $ | — | ||||
$ | 329,034 | $ | — | |||||
Balance_Sheet_Accounts_Tables
Balance Sheet Accounts (Tables) | 9 Months Ended | |||||||
Jun. 30, 2014 | ||||||||
Balance Sheet Related Disclosures [Abstract] | ' | |||||||
Schedule of Prepaid and Other Current Assets | ' | |||||||
Prepaid and other current assets consist of the following: | ||||||||
June 30, | September 30, | |||||||
2014 | 2013 | |||||||
Prepaid expenses and other current assets | ||||||||
Prepaid Product Costs | $ | — | $ | 730,003 | ||||
Prepaid FDA User Fee | — | 1,023,291 | ||||||
Prepaid Insurance | 514,141 | 117,510 | ||||||
All Other | 408,789 | 31,856 | ||||||
Total Prepaid expenses and other current assets | $ | 922,930 | $ | 1,902,660 | ||||
Schedule of Accrued Expenses | ' | |||||||
Accrued expenses consist of the following: | ||||||||
June 30, | September 30, | |||||||
2014 | 2013 | |||||||
Accrued expenses | ||||||||
Royalties Due to The Medicines Company | $ | 4,301,683 | $ | 1,724,061 | ||||
Royalties Due to SciDose | 859,868 | 546,756 | ||||||
Accrued Research & Development | 815,057 | 282,682 | ||||||
Accrued Professional Fees | 419,242 | 274,566 | ||||||
Accrued Salary | 244,158 | 169,568 | ||||||
Accrued Product Costs | 4,000 | 62,737 | ||||||
All Other | 824,786 | 69,182 | ||||||
Total Accrued expenses | $ | 7,468,794 | $ | 3,129,552 | ||||
Schedule of Deferred Revenue | ' | |||||||
Deferred revenue consists of the following: | ||||||||
June 30, | September 30, | |||||||
2014 | 2013 | |||||||
Deferred revenue | ||||||||
The Medicines Company | $ | 259,653 | $ | 519,653 | ||||
Deferred Revenue for ongoing business | 259,653 | 519,653 | ||||||
Hikma Pharmaceuticals, Co. Ltd. (See Note 10) | — | 3,500,000 | ||||||
Par Pharmaceuticals Companies, Inc. | 5,500,000 | 5,500,000 | ||||||
Par Pharmaceuticals Companies, Inc./Tech Transfer | 500,000 | 500,000 | ||||||
Deferred Revenue from Asset Sales (See Note 10) | 6,000,000 | 9,500,000 | ||||||
Total Deferred revenue | $ | 6,259,653 | $ | 10,019,653 | ||||
Common_Stock_and_StockBased_Co1
Common Stock and Stock-Based Compensation (Tables) | 9 Months Ended | |||||||||||||||
Jun. 30, 2014 | ||||||||||||||||
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ' | |||||||||||||||
Recognized Share-based Compensation in Statements of Operations | ' | |||||||||||||||
The Company recognized share-based compensation in its statements of operations for the three and nine months ended June 30, 2014 and 2013 as follows: | ||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||||
Selling, general and administrative | $ | 77,628 | $ | 84,583 | $ | 190,878 | $ | 252,626 | ||||||||
Research and development | 85,872 | 43,730 | 190,858 | 77,293 | ||||||||||||
Total | $ | 163,500 | $ | 128,313 | $ | 381,736 | $ | 329,919 | ||||||||
Organization_and_Business_Acti1
Organization and Business Activities (Details) (USD $) | 1 Months Ended | 9 Months Ended | 0 Months Ended | 0 Months Ended | 1 Months Ended | |||||||
Mar. 18, 2014 | Feb. 28, 2014 | Jun. 30, 2014 | Jun. 30, 2013 | Sep. 30, 2013 | Feb. 18, 2014 | Oct. 02, 2012 | Feb. 18, 2014 | Feb. 18, 2014 | Mar. 18, 2014 | Feb. 18, 2014 | Feb. 28, 2014 | |
IPO | Common stock | Common stock | Common stock | Common stock | Preferred stock | Warrants | ||||||
IPO | IPO | Over-allotment option | IPO | IPO | ||||||||
Subsidiary, Sale of Stock [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Issuance of common stock in connection with initial public offering, net of offering costs | ' | ' | 3,450,000 | ' | ' | ' | ' | 3,350,000 | ' | 100,000 | ' | ' |
IPO share price | ' | ' | ' | ' | ' | ' | ' | ' | $15 | ' | ' | ' |
Aggregate net proceeds received from IPO | $46,069,228 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Proceeds from exercise of preferred stock warrants | $20,868 | $20,868 | $20,868 | $0 | ' | ' | ' | ' | ' | ' | ' | ' |
Issuance of common stock upon exercise of Redeemable Series C preferred stock warrants, shares | 1,788 | 1,788 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Reverse stock split in connection with IPO | ' | ' | ' | ' | ' | 0.156 | ' | ' | ' | ' | ' | ' |
Conversion of preferred shares to common stock | ' | ' | ' | ' | ' | ' | 1,395,226 | ' | ' | ' | 7,487,928 | 32,286 |
Total issued common stock | ' | ' | 14,020,133 | ' | 3,048,131 | ' | ' | ' | ' | ' | ' | ' |
Summary_of_Significant_Account3
Summary of Significant Accounting Policies - Major Customers as a Percentage (Details) | 9 Months Ended | 12 Months Ended | 9 Months Ended | 12 Months Ended | 9 Months Ended | 12 Months Ended | 9 Months Ended | 12 Months Ended | 3 Months Ended | 9 Months Ended | 3 Months Ended | 9 Months Ended | 3 Months Ended | 9 Months Ended | ||||||
Jun. 30, 2014 | Sep. 30, 2013 | Jun. 30, 2014 | Sep. 30, 2013 | Jun. 30, 2014 | Sep. 30, 2013 | Jun. 30, 2014 | Sep. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | |
Accounts Receivable | Accounts Receivable | Accounts Receivable | Accounts Receivable | Accounts Receivable | Accounts Receivable | Accounts Receivable | Accounts Receivable | Customer Concentration Risk | Customer Concentration Risk | Customer Concentration Risk | Customer Concentration Risk | Customer Concentration Risk | Customer Concentration Risk | Customer Concentration Risk | Customer Concentration Risk | Customer Concentration Risk | Customer Concentration Risk | Customer Concentration Risk | Customer Concentration Risk | |
The Medicines Company | The Medicines Company | Sandoz, Inc. | Sandoz, Inc. | Other | Other | Net Revenues | Net Revenues | Net Revenues | Net Revenues | Net Revenues | Net Revenues | Net Revenues | Net Revenues | Net Revenues | Net Revenues | Net Revenues | Net Revenues | |||
The Medicines Company | The Medicines Company | The Medicines Company | The Medicines Company | Sandoz, Inc. | Sandoz, Inc. | Sandoz, Inc. | Sandoz, Inc. | |||||||||||||
Concentration Risk [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Percentage of concentration | 100.00% | 100.00% | 84.00% | 58.00% | 15.00% | 40.00% | 1.00% | 2.00% | 100.00% | 100.00% | 100.00% | 100.00% | 51.00% | 42.00% | 42.00% | 53.00% | 49.00% | 58.00% | 58.00% | 47.00% |
Summary_of_Significant_Account4
Summary of Significant Accounting Policies - Narrative (Details) (USD $) | 3 Months Ended | 9 Months Ended | 3 Months Ended | 9 Months Ended | 1 Months Ended | |||||
Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | Sep. 30, 2013 | Jun. 30, 2014 | |
Convertible Note and Warrant Purchase Agreement | Convertible Note and Warrant Purchase Agreement | Convertible Note and Warrant Purchase Agreement | Convertible Note and Warrant Purchase Agreement | Convertible Note and Warrant Purchase Agreement | Hikma Pharmaceuticals, Co. Ltd. | |||||
Convertible notes payable | Convertible notes payable | Convertible notes payable | Convertible notes payable | Convertible notes payable | Asset sales | |||||
Short-term Debt [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Inventory waiting upon approval to be sold | $329,034 | ' | $329,034 | ' | ' | ' | ' | ' | ' | ' |
Amortization of deferred financing costs | 0 | 38,567 | 0 | 96,417 | 0 | 38,567 | 0 | 96,416 | ' | ' |
Unamortized deferred financing costs | ' | ' | ' | ' | 0 | ' | 0 | ' | 0 | ' |
IPO costs reclassified to Additional Paid In Capital | ' | ' | 2,073,694 | ' | ' | ' | ' | ' | ' | ' |
Advertising and marketing costs | 596,024 | 0 | 685,937 | 117,977 | ' | ' | ' | ' | ' | ' |
Income tax benefit | 0 | 0 | 1,294,905 | 898,703 | ' | ' | ' | ' | ' | ' |
Royalty Revenue, Commercial Partners' Obligation of Sales Report, Term | ' | ' | '60 days | ' | ' | ' | ' | ' | ' | ' |
Deferred revenue | ' | ' | ' | ' | ' | ' | ' | ' | ' | $3,500,000 |
Summary_of_Significant_Account5
Summary of Significant Accounting Policies - Assumption of Stock Options Granted (Details) | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' | ' |
Risk-free interest minimum rate | 2.11% | 0.82% | 1.77% | 0.95% |
Risk-free interest maximum rate | 2.16% | 3.23% | 2.16% | 2.47% |
Volatility | 56.84% | 64.00% | 64.00% | ' |
Volatility minimum | ' | ' | ' | 36.58% |
Volatility maximum | ' | ' | ' | 39.65% |
Minimum | ' | ' | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' | ' |
Expected term | '6 years 7 months 2 days | '6 years 0 months 28 days | '6 years 0 months 24 days | '6 years 0 months 28 days |
Maximum | ' | ' | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' | ' |
Expected term | '10 years | '10 years | '10 years | '9 years 9 months 22 days |
Summary_of_Significant_Account6
Summary of Significant Accounting Policies - Common Shares Equivalents Outstanding (Details) | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ' | ' | ' | ' |
Anti-dilutive common shares equivalents outstanding | 990,330 | 8,340,837 | 4,506,639 | 8,485,931 |
Series A | ' | ' | ' | ' |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ' | ' | ' | ' |
Anti-dilutive common shares equivalents outstanding | 0 | 2,332,059 | 1,104,225.82 | 2,332,059 |
Series B | ' | ' | ' | ' |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ' | ' | ' | ' |
Anti-dilutive common shares equivalents outstanding | 0 | 1,980,429 | 937,729.63 | 1,980,429 |
Series B-1 | ' | ' | ' | ' |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ' | ' | ' | ' |
Anti-dilutive common shares equivalents outstanding | 0 | 1,455,750 | 689,295.05 | 1,455,750 |
Series C | ' | ' | ' | ' |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ' | ' | ' | ' |
Anti-dilutive common shares equivalents outstanding | 0 | 1,719,690 | 814,270.18 | 1,719,690 |
Series C warrants | ' | ' | ' | ' |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ' | ' | ' | ' |
Anti-dilutive common shares equivalents outstanding | 0 | 147,254 | 69,724.51 | ' |
Options | ' | ' | ' | ' |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ' | ' | ' | ' |
Anti-dilutive common shares equivalents outstanding | 990,330 | 705,655 | 891,393 | 850,749.30 |
Inventories_Details
Inventories (Details) (USD $) | Jun. 30, 2014 | Sep. 30, 2013 |
Inventory Disclosure [Abstract] | ' | ' |
Raw material - pre launch inventory | $329,034 | $0 |
Inventories | $329,034 | $0 |
Balance_Sheet_Accounts_Prepaid
Balance Sheet Accounts - Prepaid and Other Current Assets (Details) (USD $) | Jun. 30, 2014 | Sep. 30, 2013 |
Balance Sheet Related Disclosures [Abstract] | ' | ' |
Prepaid Product Costs | $0 | $730,003 |
Prepaid FDA User Fee | 0 | 1,023,291 |
Prepaid Insurance | 514,141 | 117,510 |
All Other | 408,789 | 31,856 |
Total Prepaid expenses and other current assets | $922,930 | $1,902,660 |
Balance_Sheet_Accounts_Accrued
Balance Sheet Accounts - Accrued Expenses (Details) (USD $) | Jun. 30, 2014 | Sep. 30, 2013 |
Components of Accrued Expenses [Line Items] | ' | ' |
Accrued Research & Development | $815,057 | $282,682 |
Accrued Professional Fees | 419,242 | 274,566 |
Accrued Salary | 244,158 | 169,568 |
Accrued Product Costs | 4,000 | 62,737 |
Other accrued liabilities | 824,786 | 69,182 |
Total Accrued expenses | 7,468,794 | 3,129,552 |
The Medicines Company | ' | ' |
Components of Accrued Expenses [Line Items] | ' | ' |
Royalties Due | 4,301,683 | 1,724,061 |
SciDose | ' | ' |
Components of Accrued Expenses [Line Items] | ' | ' |
Royalties Due | $859,868 | $546,756 |
Balance_Sheet_Accounts_Deferre
Balance Sheet Accounts - Deferred Revenue (Details) (USD $) | Jun. 30, 2014 | Sep. 30, 2013 |
Deferred Revenue Arrangement [Line Items] | ' | ' |
Deferred revenue | $6,259,653 | $10,019,653 |
Ongoing business | ' | ' |
Deferred Revenue Arrangement [Line Items] | ' | ' |
Deferred revenue | 259,653 | 519,653 |
Ongoing business | The Medicines Company | ' | ' |
Deferred Revenue Arrangement [Line Items] | ' | ' |
Deferred revenue | 259,653 | 519,653 |
Asset sales | ' | ' |
Deferred Revenue Arrangement [Line Items] | ' | ' |
Deferred revenue | 6,000,000 | 9,500,000 |
Asset sales | Hikma Pharmaceuticals, Co. Ltd. | ' | ' |
Deferred Revenue Arrangement [Line Items] | ' | ' |
Deferred revenue | 0 | 3,500,000 |
Asset sales excluding Tech Transfers | Par Pharmaceuticals Companies, Inc. | ' | ' |
Deferred Revenue Arrangement [Line Items] | ' | ' |
Deferred revenue | 5,500,000 | 5,500,000 |
Tech Transfer | Par Pharmaceuticals Companies, Inc. | ' | ' |
Deferred Revenue Arrangement [Line Items] | ' | ' |
Deferred revenue | $500,000 | $500,000 |
Notes_Payable_Details
Notes Payable (Details) (USD $) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 0 Months Ended | 12 Months Ended | 3 Months Ended | 12 Months Ended | 9 Months Ended | 1 Months Ended | ||||||||||||||
Mar. 18, 2014 | Feb. 28, 2014 | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | Sep. 30, 2013 | Oct. 02, 2012 | Oct. 02, 2012 | Feb. 18, 2014 | Sep. 30, 2013 | Jun. 30, 2014 | Feb. 18, 2014 | Sep. 26, 2012 | Aug. 02, 2012 | Jun. 30, 2014 | Sep. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2014 | Sep. 26, 2012 | Aug. 02, 2012 | Feb. 28, 2014 | Sep. 26, 2012 | |
Redeemable Convertible Preferred Stock | Common stock | Series C Convertible Preferred Stock | Convertible Note and Warrant Purchase Agreement | Convertible Note and Warrant Purchase Agreement | Convertible Note and Warrant Purchase Agreement | Convertible Note and Warrant Purchase Agreement | Convertible Note and Warrant Purchase Agreement | Convertible Note and Warrant Purchase Agreement | Convertible Note and Warrant Purchase Agreement | Convertible Note and Warrant Purchase Agreement | Convertible Note and Warrant Purchase Agreement | Convertible Note and Warrant Purchase Agreement | Convertible Note and Warrant Purchase Agreement | IPO | Probability-Weighted Expected Returns Valuation Model | ||||||||
Other income and expense | Other income and expense | Warrants | Series C Convertible Preferred Stock | Convertible notes payable | Convertible notes payable | Series C Preferred Stock Warrants | Convertible Note and Warrant Purchase Agreement | ||||||||||||||||
Warrants | |||||||||||||||||||||||
Short-term Debt [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Convertible Notes issued | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $9,662,755 | ' | ' | ' |
Annual interest rate | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 6.00% | ' | ' |
Warrants monthly accrual rate | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 2.00% | ' | ' | ' | ' | ' | ' | ' | ' |
Conversion price pursuant to conversion terms at maturity date | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $1.82 | ' | ' |
Conversion of stock, shares converted | ' | ' | ' | ' | ' | ' | ' | 8,943,447 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Conversion of preferred shares to common stock | ' | ' | ' | ' | ' | ' | ' | ' | 1,395,226 | 1,719,693 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 32,286 | ' |
Warrants outstanding (in shares) | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 944,210 | 0 | ' | 944,210 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Warrants liability | ' | ' | 0 | ' | 0 | ' | 1,706,829 | ' | ' | ' | 1,706,829 | ' | 2,280,378 | ' | ' | ' | ' | ' | ' | ' | ' | ' | 654,527 |
Fair value assumptions, exercise price | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $1.82 | ' | ' | ' | ' | ' |
Fair value assumptions, implied stock price | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $1.82 | ' | ' | ' | ' | ' |
Fair value assumptions, expected volatility | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 64.00% | ' | ' | ' | ' | ' |
Fair value assumptions, expected dividend rate | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 6.00% | ' | ' | ' | ' | ' |
Fair value assumptions, risk free interest rate | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 0.83% | ' | ' | ' | ' | ' |
Fair value assumptions, expiration term | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | '6 years | ' | ' | ' | ' | ' |
Expected term of warrants | ' | ' | ' | ' | '6 years | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Proceeds from exercise of preferred stock warrants | 20,868 | 20,868 | ' | ' | 20,868 | 0 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Issuance of common stock upon exercise of Redeemable Series C preferred stock warrants, shares | 1,788 | 1,788 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Warrants exercise price | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 1.82 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Change in fair value of warrant liability | ' | ' | 0 | 15,608 | 573,582 | 15,608 | ' | ' | ' | ' | ' | ' | ' | ' | ' | 382,630 | 1,052,302 | ' | ' | ' | ' | ' | ' |
Convertible preferred stock, liquidation preference multiple | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 2 | ' | ' | ' | ' |
Debt instrument, unamortized discount | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 654,528 | ' | ' | ' |
Debt interest expense | ' | ' | 0 | 218,000 | 0 | 545,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Amortization of debt discount | ' | ' | $0 | $436,350 | $0 | $1,090,878 | ' | ' | ' | ' | $545,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Shares_Subject_to_Redemption_C1
Shares Subject to Redemption b Convertible Preferred Stock (Details) (USD $) | 9 Months Ended | 0 Months Ended | 0 Months Ended | 0 Months Ended | 6 Months Ended | 0 Months Ended | |||||||||||||||||||
Jun. 30, 2014 | Feb. 18, 2014 | Oct. 02, 2012 | Mar. 08, 2007 | Jun. 30, 2014 | Sep. 30, 2013 | Oct. 03, 2012 | Feb. 18, 2014 | Oct. 02, 2012 | Aug. 11, 2008 | Jun. 30, 2014 | Sep. 30, 2013 | Oct. 03, 2012 | Feb. 18, 2014 | Oct. 02, 2012 | Jul. 31, 2011 | Jun. 30, 2014 | Sep. 30, 2013 | Oct. 03, 2012 | Sep. 30, 2012 | Aug. 02, 2012 | Feb. 18, 2014 | Apr. 11, 2013 | Jun. 30, 2014 | Sep. 30, 2013 | |
Series A Convertible Preferred Stock | Series A Convertible Preferred Stock | Series A Convertible Preferred Stock | Series A Convertible Preferred Stock | Series A Convertible Preferred Stock | Series A Convertible Preferred Stock | Series B Convertible Preferred Stock | Series B Convertible Preferred Stock | Series B Convertible Preferred Stock | Series B Convertible Preferred Stock | Series B Convertible Preferred Stock | Series B Convertible Preferred Stock | Series B-1 Convertible Preferred Stock | Series B-1 Convertible Preferred Stock | Series B-1 Convertible Preferred Stock | Series B-1 Convertible Preferred Stock | Series B-1 Convertible Preferred Stock | Series B-1 Convertible Preferred Stock | Series B-1 Convertible Preferred Stock | Series B-1 Convertible Preferred Stock | Series C Convertible Preferred Stock | Series C Convertible Preferred Stock | Series C Convertible Preferred Stock | Series C Convertible Preferred Stock | ||
Temporary Equity [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Convertible preferred stock, shares issued | ' | ' | ' | 20,237,911 | 0 | 14,948,506 | ' | ' | ' | 16,052,343 | 0 | 12,694,561 | ' | ' | ' | 10,177,085 | 0 | 9,331,374 | ' | ' | ' | ' | 11,023,232 | 0 | 11,023,232 |
Par value per share of Convertible Preferred Stock | ' | ' | ' | $0.00 | $0.00 | $0.00 | ' | ' | ' | $0.00 | $0.00 | $0.00 | ' | ' | ' | $0.00 | $0.00 | $0.00 | ' | ' | ' | ' | $0.00 | $0.00 | $0.00 |
Convertible Preferred Stock original issue price per share | ' | ' | ' | $0.97 | ' | ' | ' | ' | ' | $1.82 | ' | ' | ' | ' | ' | $1.82 | ' | ' | ' | ' | ' | ' | $1.82 | ' | ' |
Estimated fair value of convertible preferred stock | ' | ' | ' | $19,651,000 | $0 | $20,056,790 | ' | ' | ' | $29,215,266 | $0 | $30,089,853 | ' | ' | ' | $17,522,294 | $0 | $19,374,285 | ' | ' | ' | ' | $20,062,296 | $0 | $20,462,072 |
Offering cost | 1,179 | ' | ' | 179,806 | ' | ' | ' | ' | ' | 125,714 | ' | ' | ' | ' | ' | 144,250 | ' | ' | ' | ' | ' | ' | 167,465 | ' | ' |
Accumulated dividends on the Preferred Stock | ' | 97,261 | ' | ' | 0 | 5,721,608 | ' | 172,971 | ' | ' | 0 | 7,111,465 | ' | 125,096 | ' | ' | 0 | 2,535,434 | ' | ' | ' | 138,513 | ' | 0 | 567,241 |
The liquidation value of the Preferred Stock | ' | ' | ' | ' | 0 | 20,236,596 | ' | ' | ' | ' | 0 | 30,215,567 | ' | ' | ' | ' | 0 | 19,518,535 | ' | ' | ' | ' | ' | 0 | 20,629,537 |
Conversion of preferred shares to common stock | ' | 2,332,051 | 825,177 | ' | ' | ' | ' | 1,980,431 | 532,832 | ' | ' | ' | ' | 1,455,753 | 46,218 | ' | ' | ' | ' | ' | ' | 1,719,693 | ' | ' | ' |
Shares of Series B-1 Preferred Stock in exchange for satisfaction of the principal amount of debt | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 549,451 | ' | ' | ' | ' |
Convertible preferred stock, shares outstanding | ' | ' | ' | ' | 0 | 14,948,506 | ' | ' | ' | ' | 0 | 12,694,561 | ' | ' | ' | ' | 0 | 9,331,374 | ' | 9,627,634 | ' | ' | ' | 0 | 11,023,232 |
Conversion of stock, shares converted | ' | ' | 5,289,405 | ' | ' | ' | ' | ' | 3,357,782 | ' | ' | ' | ' | ' | 296,260 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Forfeitures of dividends on Convertible preferred stock | ' | ' | $1,718,102 | ' | ' | ' | ' | ' | $1,519,922 | ' | ' | ' | ' | ' | $48,572 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Convertible preferred stock, shares authorized | ' | ' | ' | ' | 0 | 14,948,506 | 14,948,506 | ' | ' | ' | 0 | 12,694,561 | 12,694,561 | ' | ' | ' | 0 | 9,331,374 | 9,331,374 | ' | ' | ' | ' | 0 | 11,901,336 |
Common_Stock_and_StockBased_Co2
Common Stock and Stock-Based Compensation - Recognized Share-based Compensation (Details) (USD $) | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' | ' | ' |
Allocated share-based compensation expense | $163,500 | $128,313 | $381,736 | $329,919 |
Selling, general and administrative | ' | ' | ' | ' |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' | ' | ' |
Allocated share-based compensation expense | 77,628 | 84,583 | 190,878 | 252,626 |
Research and development | ' | ' | ' | ' |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' | ' | ' |
Allocated share-based compensation expense | $85,872 | $43,730 | $190,858 | $77,293 |
Common_Stock_and_StockBased_Co3
Common Stock and Stock-Based Compensation - Narrative (Details) | 9 Months Ended |
Jun. 30, 2014 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ' |
Share-based payment award, award vesting period | '4 years |
Number of shares available for grant | 974,311 |
License_Agreements_of_Developm1
License Agreements of Development and Commercialization Rights (Details) (USD $) | 1 Months Ended | 9 Months Ended | 1 Months Ended | ||
31-May-08 | Apr. 30, 2008 | Jun. 30, 2014 | 31-May-08 | Jul. 31, 2013 | |
product | Collaborative Arrangement, Product [Member] | Contract Termination [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ' | ' | ' | ' | ' |
Number of products with exclusivity rights | ' | ' | 33 | ' | ' |
Marketing rights, term | ' | ' | '10 years | ' | ' |
Collaborative product development agreement, term of exclusive marketing rights for partner | ' | ' | ' | '10 years | ' |
Collaborative product development agreement, non-refundable revenue for signing | $750,000 | ' | ' | ' | ' |
Cumulative milestones upon achievement of goals | 13,000,000 | ' | ' | ' | ' |
Collaborative product development agreement, payment for product development | 2,000,000 | ' | ' | ' | ' |
Collaborative product development agreement monthly revenue | ' | 200,000 | ' | ' | ' |
Collaborative Product Development Agreement, Expected Future Receivables | ' | ' | ' | ' | $0 |
Asset_Sales_Details
Asset Sales (Details) (USD $) | 0 Months Ended | 24 Months Ended | 1 Months Ended | 24 Months Ended | ||||
Mar. 28, 2012 | Sep. 30, 2011 | Jun. 30, 2014 | Sep. 30, 2013 | Jun. 30, 2014 | Sep. 30, 2011 | Sep. 30, 2011 | Sep. 30, 2011 | |
Asset sales | Asset sales excluding Tech Transfers | Initiation of Tech Transfer [Member] | Completion of Tech Transfer [Member] | |||||
Hikma Pharmaceuticals, Co. Ltd. | Par Pharmaceuticals Companies, Inc. | Par Pharmaceuticals Companies, Inc. | Par Pharmaceuticals Companies, Inc. | |||||
Deferred Revenue Arrangement [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' |
Deferred revenue, noncurrent | ' | ' | ' | ' | ' | $5,500,000 | $250,000 | $250,000 |
Cash proceeds due to regulatory | 1,000,000 | ' | ' | ' | ' | ' | ' | ' |
Milestone reduction limit | 500,000 | ' | ' | ' | ' | ' | ' | ' |
Royalty revenue term | '10 years | ' | ' | ' | ' | ' | ' | ' |
Deferred revenue | ' | ' | ' | ' | 3,500,000 | ' | ' | ' |
Divestiture of businesses proceeds | ' | 6,500,000 | ' | ' | ' | ' | 500,000 | 500,000 |
Divestiture of business if milestones unattained | ' | ' | 6,000,000 | 6,000,000 | ' | ' | ' | ' |
Milestone addition limit | ' | ' | $3,000,000 | ' | ' | ' | ' | ' |
Commitments_Details
Commitments (Details) (USD $) | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | |
Commitments and Contingencies Disclosure [Abstract] | ' | ' | ' | ' |
Purchase obligation | $751,000 | ' | $751,000 | ' |
Operating leases rent expense | 68,104 | 63,873 | 208,457 | 270,482 |
Future operating lease payments | $249,714 | ' | $249,714 | ' |
Arbitration_Details
Arbitration (Details) (USD $) | 3 Months Ended | 9 Months Ended | 0 Months Ended | 3 Months Ended | ||
Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | Jul. 19, 2013 | Sep. 30, 2013 | |
Arbitration October 2011 | Arbitration October 2011 | |||||
Loss Contingencies [Line Items] | ' | ' | ' | ' | ' | ' |
Professional fee benefit | $0 | ($1,993,099) | $0 | ($1,993,099) | ' | ' |
Damages awarded to the Company | ' | ' | ' | ' | 5,000,000 | ' |
Apportioned costs awarded to the Company | ' | ' | ' | ' | 23,900 | ' |
Arbitration expense | ' | ' | ' | ' | ' | $973,649 |
Legal_Proceedings_Details
Legal Proceedings (Details) | 9 Months Ended |
Jun. 30, 2014 | |
Commitments and Contingencies Disclosure [Abstract] | ' |
Lawsuit invoked regulatory stay of approval | '30 months |
Orphan drug exclusivity, FDA stay of application, maximum period | '7 years |
Orphan drug exclusivity, FDA stay of application, additional domestic period for pediatric exclusivity | '6 months |