Document_and_Entity_Informatio
Document and Entity Information | 6 Months Ended | |
Mar. 31, 2015 | Apr. 30, 2015 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | FALSE | |
Document Period End Date | 31-Mar-15 | |
Document Fiscal Year Focus | 2015 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | ENTA | |
Entity Registrant Name | ENANTA PHARMACEUTICALS INC | |
Entity Central Index Key | 1177648 | |
Current Fiscal Year End Date | -21 | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 18,692,026 |
Consolidated_Balance_Sheets
Consolidated Balance Sheets (USD $) | Mar. 31, 2015 | Sep. 30, 2014 |
In Thousands, unless otherwise specified | ||
Current assets: | ||
Cash and cash equivalents | $25,751 | $30,699 |
Short-term marketable securities | 139,721 | 60,065 |
Accounts receivable | 7,081 | 1,724 |
Unbilled receivables | 1,550 | 2,770 |
Deferred tax assets | 1,451 | 11,123 |
Prepaid expenses and other current assets | 2,230 | 1,594 |
Total current assets | 177,784 | 107,975 |
Property and equipment, net | 2,295 | 1,803 |
Long-term marketable securities | 61,330 | 41,003 |
Deferred tax assets | 3,867 | 4,198 |
Restricted cash | 608 | 436 |
Total assets | 245,884 | 155,415 |
Current liabilities: | ||
Accounts payable | 2,343 | 1,874 |
Accrued expenses | 2,910 | 2,872 |
Income taxes payable | 14,537 | |
Total current liabilities | 19,790 | 4,746 |
Warrant liability | 1,442 | 1,584 |
Other long-term liabilities | 252 | 229 |
Total liabilities | 21,669 | 6,761 |
Commitments and contingencies (Note 11) | ||
Stockholders' equity: | ||
Common stock; $0.01 par value; 100,000,000 shares authorized at March 31, 2015 and September 30, 2014; 18,899,211 and 18,803,390 shares issued, and 18,690,395 and 18,594,574 shares outstanding, at March 31, 2015 and September 30, 2014, respectively | 189 | 188 |
Additional paid-in capital | 226,295 | 221,580 |
Treasury stock, at par value; 208,816 shares at March 31, 2015 and September 30, 2014, respectively | -2 | -2 |
Accumulated other comprehensive loss | -17 | -100 |
Accumulated deficit | -2,250 | -73,012 |
Total stockholders' equity | 224,215 | 148,654 |
Total liabilities and stockholders' equity | 245,884 | 155,415 |
Series 1 Nonconvertible Preferred Stock [Member] | ||
Current liabilities: | ||
Series 1 nonconvertible preferred stock | $185 | $202 |
Consolidated_Balance_Sheets_Pa
Consolidated Balance Sheets (Parenthetical) (USD $) | Mar. 31, 2015 | Sep. 30, 2014 |
Statement of Financial Position [Abstract] | ||
Common stock, par value | $0.01 | $0.01 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 18,899,211 | 18,803,390 |
Common stock, shares outstanding | 18,690,395 | 18,594,574 |
Treasury stock, shares | 208,816 | 208,816 |
Consolidated_Statements_of_Ope
Consolidated Statements of Operations (USD $) | 3 Months Ended | 6 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 | Mar. 31, 2015 | Mar. 31, 2014 |
Income Statement [Abstract] | ||||
Revenue | $57,367 | $2,160 | $134,865 | $3,053 |
Operating expenses: | ||||
Research and development | 5,368 | 4,722 | 9,887 | 8,985 |
General and administrative | 3,438 | 2,565 | 6,207 | 4,652 |
Total operating expenses | 8,806 | 7,287 | 16,094 | 13,637 |
Income (loss) from operations | 48,561 | -5,127 | 118,771 | -10,584 |
Other income (expense): | ||||
Interest income | 229 | 114 | 356 | 223 |
Interest expense | -2 | -4 | -4 | -9 |
Change in fair value of warrant liability and Series 1 nonconvertible preferred stock | -17 | -186 | 159 | -203 |
Total other income (expense), net | 210 | -76 | 511 | 11 |
Net income (loss) before income taxes | 48,771 | -5,203 | 119,282 | -10,573 |
Income tax expense | -20,018 | 0 | -48,520 | 0 |
Net income (loss) | $28,753 | ($5,203) | $70,762 | ($10,573) |
Net income (loss) per share: | ||||
Basic | $1.54 | ($0.28) | $3.80 | ($0.58) |
Diluted | $1.49 | ($0.28) | $3.67 | ($0.58) |
Weighted average common shares outstanding: | ||||
Basic | 18,679,898 | 18,353,628 | 18,641,060 | 18,149,330 |
Diluted | 19,268,565 | 18,353,628 | 19,275,969 | 18,149,330 |
Consolidated_Statements_of_Com
Consolidated Statements of Comprehensive Income (Loss) (USD $) | 3 Months Ended | 6 Months Ended | ||
In Thousands, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 | Mar. 31, 2015 | Mar. 31, 2014 |
Statement of Comprehensive Income [Abstract] | ||||
Net income (loss) | $28,753 | ($5,203) | $70,762 | ($10,573) |
Other comprehensive income: | ||||
Net unrealized gains on marketable securities, net of tax of $55, $0, $58 and $0 | 78 | 29 | 83 | 63 |
Total other comprehensive income | 78 | 29 | 83 | 63 |
Comprehensive income (loss) | $28,831 | ($5,174) | $70,845 | ($10,510) |
Consolidated_Statements_of_Com1
Consolidated Statements of Comprehensive Income (Loss) (Parenthetical) (USD $) | 3 Months Ended | 6 Months Ended | ||
In Thousands, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 | Mar. 31, 2015 | Mar. 31, 2014 |
Statement of Comprehensive Income [Abstract] | ||||
Net unrealized gains (losses) on marketable securities, tax | $55 | $0 | $58 | $0 |
Consolidated_Statements_of_Cas
Consolidated Statements of Cash Flows (USD $) | 6 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
Cash flows from operating activities | ||
Net income (loss) | $70,762 | ($10,573) |
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: | ||
Depreciation and amortization expense | 270 | 154 |
Non-cash interest expense | 4 | 9 |
Change in fair value of warrant liability and Series 1 nonconvertible preferred stock | -159 | 203 |
Stock-based compensation expense | 2,457 | 1,111 |
Gain on sale of marketable securities | -1 | |
Premium on marketable securities | -1,621 | -473 |
Amortization of premium on marketable securities | 1,032 | 1,202 |
Deferred income taxes | 11,864 | |
Income tax benefit from exercise of stock options | -1,919 | |
Changes in operating assets and liabilities: | ||
Accounts receivable | -5,357 | -190 |
Unbilled receivables | 1,220 | -820 |
Prepaid expenses and other current assets | 42 | -293 |
Accounts payable | 488 | 316 |
Accrued expenses | -391 | -718 |
Income taxes payable | 14,537 | |
Deferred revenue | 41 | |
Other long-term liabilities | 23 | 30 |
Net cash provided by (used in) operating activities | 93,251 | -10,001 |
Cash flows from investing activities | ||
Purchases of property and equipment | -356 | -165 |
Increase in restricted cash | -172 | |
Purchases of marketable securities | -135,832 | -24,572 |
Sales of marketable securities | 2,210 | 7,413 |
Maturities of marketable securities | 33,692 | 35,921 |
Net cash provided by (used in) investing activities | -100,458 | 18,597 |
Cash flows from financing activities | ||
Proceeds from exercise of stock options | 340 | 646 |
Income tax benefit from exercise of stock options | 1,919 | |
Net cash provided by financing activities | 2,259 | 646 |
Net decrease in cash and cash equivalents | -4,948 | 9,242 |
Cash and cash equivalents at beginning of period | 30,699 | 8,859 |
Cash and cash equivalents at end of period | 25,751 | 18,101 |
Supplemental disclosure of cash flow information: | ||
Cash paid for income taxes | 22,066 | |
Series 1 Nonconvertible Preferred Stock [Member] | ||
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: | ||
Change in fair value of warrant liability and Series 1 nonconvertible preferred stock | ($159) | $203 |
Nature_of_the_Business_and_Bas
Nature of the Business and Basis of Presentation | 6 Months Ended | |
Mar. 31, 2015 | ||
Accounting Policies [Abstract] | ||
Nature of the Business and Basis of Presentation | 1 | Nature of the Business and Basis of Presentation |
Enanta Pharmaceuticals, Inc. (the “Company”), incorporated in Delaware in 1995, is a research and development-focused biotechnology company that uses its chemistry-driven approach and drug discovery capabilities to create small molecule drugs for the treatment of viral infections and liver diseases. The Company has programs to develop novel protease, NS5A, cyclophilin and nucleotide polymerase inhibitors targeted against the hepatitis C virus (“HCV”) and also recently announced a new focus area in non-alcoholic steatohepatitis (“NASH”). Additionally, the Company has programs to discover new chemical entities for the treatment of other diseases. | ||
The Company is subject to risks common to companies in the biotechnology industry including, but not limited to, the uncertainties of research and development, competition from technological innovations of others, dependence on collaborative arrangements, protection of proprietary technology, dependence on key personnel, compliance with government regulations and the need for financial resources to fund research and development activities. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval, prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel infrastructure and extensive compliance reporting capabilities. | ||
Unaudited Interim Financial Information | ||
The consolidated balance sheet at September 30, 2014 was derived from the audited financial statements, but does not include all disclosures required by accounting principles generally accepted in the United States of America (“GAAP”). The accompanying unaudited consolidated financial statements as of March 31, 2015 and for the three and six months ended March 31, 2015 and 2014 have been prepared by the Company, pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial statements. Certain information and note disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. These financial statements should be read in conjunction with the Company’s audited financial statements and the notes thereto for the fiscal year ended September 30, 2014 included in the Company’s Annual Report on Form 10-K for that fiscal year. | ||
In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for a fair statement of the Company’s financial position as of March 31, 2015 and results of operations for the three and six months ended March 31, 2015 and 2014 and cash flows for the six months ended March 31, 2015 and 2014 have been made. The results of operations for the three and six months ended March 31, 2015 are not necessarily indicative of the results of operations that may be expected for subsequent quarters or the year ending September 30, 2015. | ||
The accompanying consolidated financial statements have been prepared in conformity with GAAP. All dollar amounts in the consolidated financial statements and in the notes to the consolidated financial statements, except share and per share amounts, are in thousands unless otherwise indicated. |
Summary_of_Significant_Account
Summary of Significant Accounting Policies | 6 Months Ended | |
Mar. 31, 2015 | ||
Accounting Policies [Abstract] | ||
Summary of Significant Accounting Policies | 2 | Summary of Significant Accounting Policies |
Use of Estimates | ||
The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements, and the reported amounts of revenues and expenses during the reporting period. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, valuation of warrants, Series 1 nonconvertible preferred stock and stock-based awards; the useful lives of property and equipment; and the accounting for income taxes, including uncertain tax positions. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Actual results could differ from the Company’s estimates. | ||
Revenue Recognition | ||
The Company’s revenue has been generated primarily through collaborative research and license agreements. The terms of these agreements contain multiple deliverables, which may include (i) licenses, (ii) research and development activities, and (iii) participation in joint research and development steering committees. The terms of these agreements may include nonrefundable upfront license fees, payments for research and development activities, payments based upon the achievement of certain milestones, and royalty payments based on product sales derived from the collaboration. In all instances, revenue is recognized only when the price is fixed or determinable, persuasive evidence of an arrangement exists, delivery has occurred or the services have been rendered, collectibility of the resulting receivable is reasonably assured, and the Company has fulfilled its performance obligations under the contract. | ||
For agreements entered into prior to October 1, 2011, the Company evaluated license agreements with multiple deliverables to determine if the deliverable elements could be recognized separately by considering (i) if the delivered elements (typically the license) had standalone value to the customer, (ii) if the fair value of any undelivered elements (typically the research and development services and the steering committee activities) could be determined based on vendor-specific objective evidence (“VSOE”) or vendor objective evidence (“VOE”), and (iii) if the arrangement included a general right of return relative to the delivered item, the delivery or performance of the undelivered item was considered probable and substantially within the control of the Company. VSOE of fair value was based on the consistent price of a deliverable when the Company regularly sold it on a standalone basis. Alternatively, VOE was based upon third-party objective evidence of fair value. If the delivered elements had value on a standalone basis and the fair value of the undelivered elements could be determined based on VSOE or VOE, revenues of such elements were then accounted for separately as delivered with arrangement consideration allocated to the delivered elements based on the residual value method. If either (i) the delivered elements were considered to not have standalone value or (ii) VSOE or VOE of fair value for any of the undelivered elements could not be determined, the arrangement was accounted for as a single unit of accounting and all payments received were recognized as revenue over the estimated period of performance of the entire arrangement. | ||
On October 1, 2011, the Company adopted Accounting Standards Update (“ASU”) No. 2009-13, Multiple-Deliverable Revenue Arrangements (“ASU 2009-13”). This guidance, which applies to multiple-element arrangements entered into or materially modified on or after October 1, 2011, amends the criteria for separating and allocating consideration in a multiple-element arrangement by modifying the fair value requirements for revenue recognition and eliminating the use of the residual value method. The selling prices of deliverables under the arrangement may be derived using third-party evidence (“TPE”) or a best estimate of selling price (“BESP”), if VSOE is not available. The objective of BESP is to determine the price at which the Company would transact a sale if the element within the license agreement was sold on a standalone basis. Establishing BESP involves management’s judgment and considers multiple factors, including market conditions and company-specific factors including those factors contemplated in negotiating the agreements as well as internally developed models that include assumptions related to market opportunity, discounted cash flows, estimated development costs, probability of success, and the time needed to commercialize a product candidate pursuant to the license. In validating the Company’s BESP, the Company considers whether changes in key assumptions used to determine the BESP will have a significant effect on the allocation of the arrangement consideration between the multiple deliverables. Deliverables under the arrangement are separate units of accounting if (i) the delivered item has value to the customer on a standalone basis, and (ii) if the arrangement includes a general right of return relative to the delivered item, delivery or performance of the undelivered item is considered probable and substantially within the control of the Company. The arrangement consideration that is fixed or determinable at the inception of the arrangement is allocated to the separate units of accounting based on their relative selling prices. The appropriate revenue recognition model is applied to each element, and revenue is accordingly recognized as each element is delivered. The Company may exercise significant judgment in determining whether a deliverable is a separate unit of accounting. The Company elected to adopt ASU 2009-13 prospectively as of October 1, 2011. | ||
In determining the separate units of accounting, the Company evaluates whether the license has standalone value to the collaborator based on consideration of the relevant facts and circumstances for each arrangement. Factors considered in this determination include the research and development capabilities of the collaborator and the availability of relevant research expertise in the marketplace. In addition, the Company considers whether or not (i) the collaborator can use the license for its intended purpose without the receipt of the remaining deliverables, (ii) the value of the license is dependent on the undelivered items, and (iii) the collaborator or other vendors can provide the undelivered items. | ||
Under a collaborative research and license agreement, a steering committee is typically responsible for overseeing the general working relationships, determining the protocols to be followed in the research and development performed, and evaluating the results from the continued development of the product in order to determine the clinical studies to be performed. The Company evaluates whether its participation in joint research and development steering committees is a substantive obligation or whether the services are considered inconsequential or perfunctory. The Company’s participation on a steering committee is considered “participatory” and therefore accounted for as a separate element when the collaborator requires the participation of the Company to ensure all elements of an arrangement are maximized. Steering committee services that are considered participatory are combined with other research services or performance obligations required under an arrangement, if any, in determining the level of effort required in an arrangement and the period over which the Company expects to complete its aggregate performance obligations. Alternatively, the Company’s participation on a steering committee is considered “protective” and therefore not accounted for as a separate element in a case where the Company can exercise or control when to be involved at its own discretion. Factors the Company considers in determining if its participation in a joint steering committee is participating or protective include: (i) which party negotiated or requested the steering committee, (ii) how frequently the steering committee meets, (iii) whether or not there are any penalties or other recourse if the Company does not attend the steering committee meetings, (iv) which party has decision making authority on the steering committee, and (v) whether or not the collaborator has the requisite experience and expertise associated with the research and development of the licensed intellectual property. | ||
For all periods presented, whenever the Company determines that an element is delivered over a period of time, revenue is recognized using either a proportional performance model or a straight-line model over the period of performance, which is typically the research and development term. Full-time equivalents (“FTEs”) are typically used as the measure of performance. At each reporting period, the Company reassesses its cumulative measure of performance and makes appropriate adjustments, if necessary. The Company recognizes revenue using the proportional performance model whenever the Company can make reasonably reliable estimates of the level of effort required to complete its performance obligations under an arrangement. Revenue recognized under the proportional performance model at each reporting period is determined by multiplying the total expected payments under the contract (excluding royalties and payments contingent upon achievement of milestones) by the ratio of the level of effort incurred to date to the estimated total level of effort required to complete the performance obligations under the arrangement. Revenue is limited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined using the proportional performance model as of each reporting period. Alternatively, if the Company cannot make reasonably reliable estimates of the level of effort required to complete its performance obligations under an arrangement, then revenue under the arrangement is recognized on a straight-line basis over the period expected to complete the Company’s performance obligations. If and when a contingent milestone payment is earned, the additional consideration to be received is allocated to the separate units of accounting in the arrangement based on their relative selling prices at the inception of the arrangement. Revenue is limited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined on a straight-line basis as of the period end date. If the Company cannot reasonably estimate when its performance obligation period ends, then revenue is deferred until the Company can reasonably estimate when the performance obligation period ends. | ||
Royalty revenue is recognized based on contractual terms when reported sales are reliably measurable and collectibility is reasonably assured, provided that there are no performance obligations then remaining. | ||
During the three and six months ended March 31, 2015 and 2014, the Company also generated revenue from a government contract, under which the Company is reimbursed for certain allowable costs for the funded project. Revenue from the government contract is recognized when the related service is performed. The related costs incurred by the Company under the government contract are included in research and development expenses in the statements of operations. | ||
Amounts received prior to satisfying all revenue recognition criteria are recorded as deferred revenue in the accompanying consolidated balance sheets. Amounts not expected to be recognized as revenue within the next twelve months of the consolidated balance sheet date are classified as long-term deferred revenue. | ||
In the event that a collaborative research and license agreement is terminated and the Company then has no further performance obligations, the Company recognizes as revenue any amounts that had not previously been recorded as revenue but were classified as deferred revenue at the date of such termination. | ||
Recently Issued Accounting Pronouncements | ||
In May, 2014, the Financial Accounting Standards Board (the “FASB”) issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606), which supersedes all existing revenue recognition requirements, including most industry-specific guidance. The new standard requires a company to recognize revenue when it transfers goods or services to customers in an amount that reflects the consideration that the company expects to receive for those goods or services. The new standard will be effective for the Company on October 1, 2017; however there is a pending proposal to delay the effective period by one year. The Company is currently evaluating the potential impact that Topic 606 may have on its financial position and results of operations. |
Fair_Value_of_Financial_Assets
Fair Value of Financial Assets and Liabilities | 6 Months Ended | ||||||||||||||||
Mar. 31, 2015 | |||||||||||||||||
Fair Value Disclosures [Abstract] | |||||||||||||||||
Fair Value of Financial Assets and Liabilities | 3 | Fair Value of Financial Assets and Liabilities | |||||||||||||||
The following tables present information about the Company’s financial assets and liabilities that were subject to fair value measurement on a recurring basis as of March 31, 2015 and September 30, 2014 and indicate the fair value hierarchy of the valuation inputs utilized to determine such fair value: | |||||||||||||||||
Fair Value Measurements as of March 31, 2015 Using: | |||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | ||||||||||||||
Assets: | |||||||||||||||||
Money market fund | $ | 22,364 | $ | — | $ | — | $ | 22,364 | |||||||||
Commercial paper | — | 12,484 | — | 12,484 | |||||||||||||
Corporate bonds | — | 156,003 | — | 156,003 | |||||||||||||
U.S. Agency bonds | — | 32,564 | — | 32,564 | |||||||||||||
$ | 22,364 | $ | 201,051 | $ | — | $ | 223,415 | ||||||||||
Liabilities: | |||||||||||||||||
Warrant liability | $ | — | $ | — | $ | 1,442 | $ | 1,442 | |||||||||
Series 1 nonconvertible preferred stock | — | — | 185 | 185 | |||||||||||||
$ | — | $ | — | $ | 1,627 | $ | 1,627 | ||||||||||
Fair Value Measurements as of September 30, 2014 Using: | |||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | ||||||||||||||
Assets: | |||||||||||||||||
Money market fund | $ | 30,239 | $ | — | $ | — | $ | 30,239 | |||||||||
Commercial paper | — | 7,499 | — | 7,499 | |||||||||||||
Corporate bonds | — | 88,056 | — | 88,056 | |||||||||||||
U.S. Agency bonds | — | 5,513 | — | 5,513 | |||||||||||||
$ | 30,239 | $ | 101,068 | $ | — | $ | 131,307 | ||||||||||
Liabilities: | |||||||||||||||||
Warrant liability | $ | — | $ | — | $ | 1,584 | $ | 1,584 | |||||||||
Series 1 nonconvertible preferred stock | — | — | 202 | 202 | |||||||||||||
$ | — | $ | — | $ | 1,786 | $ | 1,786 | ||||||||||
During the three and six months ended March 31, 2015 and 2014, there were no transfers between Level 1, Level 2 and Level 3. | |||||||||||||||||
As of March 31, 2015 and September 30, 2014, the warrant liability was comprised of the values of warrants for the purchase of Series 1 nonconvertible preferred stock measured at fair value. The outstanding Series 1 nonconvertible preferred stock was also measured at fair value. The fair value of both of these instruments was based on significant inputs not observable in the market, which represented a Level 3 measurement within the fair value hierarchy. The Company utilized a probability-weighted valuation model which takes into consideration various outcomes that may require the Company to transfer assets upon exercise. The fair value of warrants to purchase our Series 1 nonconvertible preferred stock was $1,442 and $1,584, at March 31, 2015 and September 30, 2014, respectively. The fair value of Series 1 nonconvertible preferred stock was $185 and $202 as of March 31, 2015 and September 30, 2014, respectively. Changes in the fair value of the warrant liability and Series 1 nonconvertible preferred stock are recognized in the consolidated statements of operations. | |||||||||||||||||
The recurring Level 3 fair value measurements of the Company’s warrant liability and Series 1 nonconvertible preferred stock using probability-weighted discounted cash flow include the following significant unobservable inputs: | |||||||||||||||||
Unobservable Input | Range | ||||||||||||||||
(Weighted | |||||||||||||||||
Average) | |||||||||||||||||
Warrant liability and Series 1 nonconvertible preferred stock | Probabilities of payout | 10% - 55% | |||||||||||||||
Periods in which payout is expected to occur | 2016 – 2017 | ||||||||||||||||
Discount rate | 4.25% | ||||||||||||||||
The following table provides a rollforward of the aggregate fair values of the Company’s warrants for the purchase of Series 1 nonconvertible preferred stock and the outstanding Series 1 nonconvertible preferred stock for which fair value is determined by Level 3 inputs: | |||||||||||||||||
Warrant | Series 1 | ||||||||||||||||
liability | nonconvertible | ||||||||||||||||
preferred | |||||||||||||||||
stock | |||||||||||||||||
Balance, September 30, 2014 | $ | 1,584 | $ | 202 | |||||||||||||
Decrease in fair value | (142 | ) | (17 | ) | |||||||||||||
Balance, March 31, 2015 | $ | 1,442 | $ | 185 | |||||||||||||
Marketable_Securities
Marketable Securities | 6 Months Ended | ||||||||||||||||
Mar. 31, 2015 | |||||||||||||||||
Investments, Debt and Equity Securities [Abstract] | |||||||||||||||||
Marketable Securities | 4 | Marketable Securities | |||||||||||||||
As of March 31, 2015 and September 30, 2014, the fair value of available-for-sale marketable securities by type of security was as follows: | |||||||||||||||||
March 31, 2015 | |||||||||||||||||
Amortized Cost | Gross Unrealized | Gross Unrealized | Fair Value | ||||||||||||||
Gains | Losses | ||||||||||||||||
Commercial paper | $ | 12,484 | $ | — | $ | — | $ | 12,484 | |||||||||
Corporate bonds | 155,984 | 98 | (79 | ) | 156,003 | ||||||||||||
U.S. Agency bonds | 32,542 | 22 | — | 32,564 | |||||||||||||
$ | 201,010 | $ | 120 | $ | (79 | ) | $ | 201,051 | |||||||||
September 30, 2014 | |||||||||||||||||
Amortized Cost | Gross Unrealized | Gross Unrealized | Fair Value | ||||||||||||||
Gains | Losses | ||||||||||||||||
Commercial paper | $ | 7,499 | $ | — | $ | — | $ | 7,499 | |||||||||
Corporate bonds | 88,156 | 14 | (114 | ) | 88,056 | ||||||||||||
U.S. Agency bonds | 5,513 | — | — | 5,513 | |||||||||||||
$ | 101,168 | $ | 14 | $ | (114 | ) | $ | 101,068 | |||||||||
As of March 31, 2015, marketable securities consisted of investments that mature within one year, with the exception of certain corporate bonds, which have maturities within two years and an aggregate fair value of $61,330. | |||||||||||||||||
As of September 30, 2014, marketable securities consisted of investments that mature within one year, with the exception of certain corporate bonds and U.S. Agency bonds, which have maturities within three years and an aggregate fair value of $41,003. |
Accrued_Expenses_and_Other_Lon
Accrued Expenses and Other Long-Term Liabilities | 6 Months Ended | ||||||||
Mar. 31, 2015 | |||||||||
Payables and Accruals [Abstract] | |||||||||
Accrued Expenses and Other Long-Term Liabilities | 5 | Accrued Expenses and Other Long-Term Liabilities | |||||||
Accrued expenses (current) and other long-term liabilities consisted of the following as of March 31, 2015 and September 30, 2014: | |||||||||
March 31, | September 30, | ||||||||
2015 | 2014 | ||||||||
Accrued expenses: | |||||||||
Accrued payroll and related expenses | $ | 683 | $ | 1,275 | |||||
Accrued preclinical and clinical expenses | 517 | 493 | |||||||
Accrued vendor manufacturing expenses | 563 | 116 | |||||||
Accrued third-party license fees | 196 | 240 | |||||||
Accrued professional fees | 328 | 436 | |||||||
Accrued other | 623 | 312 | |||||||
$ | 2,910 | $ | 2,872 | ||||||
Other long-term liabilities: | |||||||||
Accrued rent expense | $ | 161 | $ | 153 | |||||
Asset retirement obligation | 91 | 76 | |||||||
$ | 252 | $ | 229 | ||||||
Collaboration_Agreements
Collaboration Agreements | 6 Months Ended | |
Mar. 31, 2015 | ||
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Collaboration Agreements | 6 | Collaboration Agreements |
AbbVie Collaboration | ||
On November 27, 2006, the Company entered into a Collaborative Development and License Agreement (the “AbbVie Agreement”) with Abbott Laboratories to identify, develop and commercialize HCV NS3 and NS3/4A protease inhibitor compounds, including paritaprevir (previously known as ABT-450). The agreement, which was amended in January and December 2009, was assigned by Abbott to AbbVie Inc. on January 1, 2013 in connection with Abbott’s transfer of its research-based pharmaceuticals business to AbbVie. The agreement was subsequently amended further in October 2014 and March 2015. | ||
Under the terms of the AbbVie Agreement, as amended, AbbVie paid to the Company upfront license payments and FTE reimbursements to fund research activities. The Company is also eligible to receive milestone payments for the successful development by AbbVie of one or more HCV compounds as well as annually tiered royalties per product ranging from the low double digits up to twenty percent, or on a blended basis from the low double digits up to the high teens, on net sales by AbbVie allocated to the collaboration’s protease inhibitors. Under the terms of the agreement, as amended in October 2014, 30% of net sales of a 3-DAA regimen containing paritaprevir will be allocated to paritaprevir, and 45% of net sales of a 2-DAA regimen containing paritaprevir will be allocated to paritaprevir. For ABT-493, 50% of net sales of a 2-DAA regimen containing ABT-493 will be allocated to ABT-493, and 33 1⁄3% of net sales of a 3-DAA regimen containing ABT-493 will be allocated to ABT-493. If there is any active ingredient other than DAA’s in any ABT-493-containing regimen sold by AbbVie, there will be a further adjustment to net sales based on the relative value of the non-DAA ingredient. | ||
Deliverables under the AbbVie Agreement included a license, research services and participation on a steering committee. The Company concluded that all deliverables under the AbbVie Agreement should be treated as a single unit of accounting. Accordingly, revenue was recognized using the proportional performance model over the period during which the Company performed research services. The Company completed all remaining service obligations under the agreement as of June 2011. All milestone payments received after June 2011 are recognized as revenue when the respective milestone is achieved by AbbVie. | ||
Through September 30, 2014, the Company had received upfront license payments, proceeds from a sale of preferred stock, research funding payment, and milestone payments totaling $160,000 from AbbVie. | ||
In December 2014, the Company earned and recognized as revenue a $75,000 milestone amount due from AbbVie as a result of U.S. regulatory approval by the FDA for AbbVie’s first treatment regimen containing a collaboration compound. In January 2015, the Company earned and recognized as revenue a $50,000 milestone payment from AbbVie upon commercialization regulatory approval of VIEKIRAX in Europe. | ||
As a result, during the three and six months ended March 31, 2015, the Company recognized milestone revenue of $50,000 and $125,000, respectively. The Company’s first product, paritaprevir, was a part of AbbVie’s new treatment regimen for HCV approved by the FDA on December 19, 2014. During the three and six months ended March 31, 2015, the Company recognized royalty revenue of $6,961 and $8,353, respectively. | ||
As of March 31, 2015, the Company was eligible to receive additional milestone payments totaling up to $30,000 upon AbbVie’s achievement of commercialization regulatory approval of a paritaprevir-containing regimen in Japan. The Company is also eligible to receive additional milestone payments totaling up to $80,000 upon AbbVie’s achievement of similar commercialization regulatory approval milestones in the U.S. and other selected world markets for each additional protease inhibitor commercialized by AbbVie. | ||
Novartis Collaboration | ||
On February 16, 2012, the Company entered into a license and collaboration agreement with Novartis (the “Novartis Agreement”) for the development, manufacture and commercialization of its lead development candidate, EDP-239, from its NS5A HCV inhibitor program. | ||
On September 30, 2014 the Company entered into an amendment to its 2012 collaboration and license agreement with Novartis to return to the Company full rights to its NS5A inhibitor program, including EDP-239, and to transition the proof-of-concept study to the Company. The Company owes no future payments to Novartis in connection with this transfer except for any unused drug product or ingredients that the Company may choose to buy from Novartis. | ||
NIAID Contract | ||
On September 30, 2011, the Company entered into a contract with the National Institute of Allergy and Infectious Diseases (“NIAID”), a division of the National Institutes of Health (“NIH”), which contract provided for up to $42,700 in potential development funding to the Company over a five-year period. Under this contract NIAID has funded the preclinical and clinical development of a bridged bicyclic antibiotic to be used as a medical countermeasure against multiple biodefense Category A and B bacteria. | ||
Funding originally paid or committed by NIAID has totaled approximately $23,500. In December 2014, the company communicated to NIAID its strategic decision not to continue commercial development of the antibiotic candidate for non-biodefense indications. In February 2015, NIAID and the Company amended the contract to decrease the total committed funding to $21,000 and its completion date to August 2015 upon the Company’s delivery of the study report for the Phase 1 clinical study. | ||
The Company recognizes revenue under this agreement as development services are performed in accordance with the funding agreement. During the three months ended March 31, 2015 and 2014, $406 and $2,160 of revenue, respectively, was recognized under this agreement. During the six months ended March 31, 2015 and 2014, the Company recognized revenue of $1,512 and $3,053, respectively. |
Warrants_to_Purchase_Series_1_
Warrants to Purchase Series 1 Nonconvertible Preferred Stock and Series 1 Nonconvertible Preferred Stock | 6 Months Ended | |
Mar. 31, 2015 | ||
Equity [Abstract] | ||
Warrants to Purchase Series 1 Nonconvertible Preferred Stock and Series 1 Nonconvertible Preferred Stock | 7 | Warrants to Purchase Series 1 Nonconvertible Preferred Stock and Series 1 Nonconvertible Preferred Stock |
In October and November 2010, the Company issued warrants to purchase up to a total of 1,999,989 shares of Series 1 nonconvertible preferred stock, which expire on October 4, 2017. As these warrants are free-standing financial instruments that may require the Company to transfer assets upon exercise, these warrants are classified as liabilities. The Company is required to remeasure the fair value of these preferred stock warrants at each reporting date, with any adjustments recorded within the change in fair value of warrant liability included in other income (expense) in the consolidated statement of operations. On February 5, 2014, 225,408 warrants were exercised resulting in the net issuance of 223,153 shares of Series 1 nonconvertible preferred stock. As of March 31, 2015 and September 30, 2014, the total fair value of the Series 1 nonconvertible preferred stock was $185 and $202, respectively. As of March 31, 2015 and September 30, 2014, the total fair value of the Series 1 nonconvertible preferred stock warrants was $1,442 and $1,584, respectively. |
StockBased_Awards
Stock-Based Awards | 6 Months Ended | ||||||||||||||||
Mar. 31, 2015 | |||||||||||||||||
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||||||||||||||||
Stock-Based Awards | 8 | Stock-Based Awards | |||||||||||||||
2012 Equity Incentive Plan | |||||||||||||||||
The Company’s 2012 Equity Incentive Plan (the “2012 Plan”) permits the Company to sell or issue common stock or restricted common stock or to grant incentive stock options or nonqualified stock options for the purchase of common stock, restricted stock units, stock appreciation rights or other cash incentive awards, to employees, members of the board of directors and consultants of the Company. The number of shares of common stock that may be issued under the 2012 Plan is subject to increase by the number of shares forfeited under any options terminated and not exercised under the 2012 Plan or the previous plan, known as the 1995 Equity Incentive Plan, as well as by a number of additional shares automatically on the first day of each fiscal year equal to the lowest amount among the following: (i) 3% of the Company’s outstanding shares of common stock as of that date, (ii) 2,088,167 shares of common stock, or (iii) a lower amount determined by the board of directors. On October 1, 2014, the number of shares of common stock that may be issued under the 2012 Plan was increased by 557,863. As of March 31, 2015, 529,176 shares remained available for future grant. | |||||||||||||||||
Stock Option Valuation | |||||||||||||||||
The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model. To date the Company lacks sufficient company-specific historical volatility information. Therefore, it estimates its expected stock volatility based on the historical volatility of a selected group of publicly traded peer companies and expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own traded stock price. The expected term of the Company’s stock options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future. The relevant data used to determine the value of the stock option grants is as follows, presented on a weighted average basis: | |||||||||||||||||
Three Months Ended March 31, | Six Months Ended March 31, | ||||||||||||||||
2015 | 2014 | 2015 | 2014 | ||||||||||||||
Risk-free interest rate | 1.65 | % | 1.93 | % | 1.85 | % | 1.9 | % | |||||||||
Expected term (in years) | 5.73 | 6.07 | 6.01 | 6.09 | |||||||||||||
Expected volatility | 72 | % | 77 | % | 75 | % | 74 | % | |||||||||
Expected dividend yield | 0 | % | 0 | % | 0 | % | 0 | % | |||||||||
The Company recognizes compensation expense for only the portion of awards that are expected to vest. In developing a forfeiture rate estimate, the Company has considered its historical experience to estimate pre-vesting forfeitures for service-based awards. The impact of a forfeiture rate adjustment will be recognized in full in the period of adjustment, and if the actual forfeiture rate is materially different from the Company’s estimate, the Company may be required to record adjustments to stock-based compensation expense in future periods. | |||||||||||||||||
As required by the 2012 Plan, the exercise price for awards granted is not to be less than the fair value of common shares as estimated by the Company as of the date of grant. For the periods prior to the March 2013 IPO, the Company valued its common stock by taking into consideration its most recently available valuation of common shares performed by management and the board of directors as well as additional factors which may have changed since the date of the most recent contemporaneous valuation through the date of grant. For the periods after the IPO, the Company based fair value of its common stock on the quoted market price. | |||||||||||||||||
The following table summarizes stock option activity during the six months ended March 31, 2015: | |||||||||||||||||
Shares | Weighted | Weighted | Aggregate | ||||||||||||||
Issuable | Average | Average | Intrinsic | ||||||||||||||
Under | Exercise | Remaining | Value | ||||||||||||||
Options | Price | Contractual | |||||||||||||||
Term | |||||||||||||||||
(in years) | |||||||||||||||||
Outstanding as of September 30, 2014 | 1,389,437 | $ | 15.39 | 7.2 | $ | 33,573 | |||||||||||
Granted | 408,455 | 42.24 | |||||||||||||||
Exercised | (95,821 | ) | 3.54 | ||||||||||||||
Expired | (8,625 | ) | 20.73 | ||||||||||||||
Outstanding as of March 31, 2015 | 1,693,446 | $ | 22.51 | 7.5 | $ | 19,109 | |||||||||||
Options vested and expected to vest as of March 31, 2015 | 1,507,790 | $ | 23.26 | 7.5 | $ | 11,787 | |||||||||||
Options exercisable as of March 31, 2015 | 729,603 | $ | 11.04 | 5.6 | $ | 14,658 | |||||||||||
In March 2013, the Company granted certain executives a total of 167,052 options that vest upon the achievement of certain performance-based targets. The grant date fair value of these options was $2,479. During the three and six months ended March 31, 2015, the Company recorded no compensation expense related to these options as none of the remaining performance-based targets became probable of being achieved during these periods. During the three months ended March 31, 2014, one performance-based target was achieved and the Company recorded compensation expense of $206 related to that target. | |||||||||||||||||
Market and Performance-based Stock Awards | |||||||||||||||||
In February 2015, the Company awarded certain executive officers a total of 41,800 share units consisting of 20,900 performance share units, or PSUs, and 20,900 relative total shareholder return units, or rTSRUs. The number of units represents the target number of shares of common stock that may be earned; however, the actual number of shares that may be earned ranges from 0% to 200% of the target number. | |||||||||||||||||
The PSUs will vest and result in issuance, or settlement, of common shares, based upon continued employment and achievement of specified research and development milestones on or before December 16, 2016. The aggregate grant date fair value of the 20,900 PSUs ranges between $0 and $1,501. During the three months ended March 31, 2015, the Company recorded no compensation expense related to the PSU awards as none of the performance-based targets was probable of being achieved during this period. | |||||||||||||||||
The rTSRUs will vest and result in the issuance of common stock based on continuing employment and the relative ranking of the total shareholder return, or TSR, of the Company’s common stock in relation to the TSR of the component companies in the NASDAQ Biotech Index over a two-year period based on a comparison of average closing stock prices in December 2014 and December 2016. The number of market-based rTSRUs awarded represents the target number of shares of common stock that may be earned; however, the actual number of shares that may be earned ranges from 0% to 200% of the target number. | |||||||||||||||||
The Company used a Monte Carlo simulation model to estimate that the grant-date fair value of the rTSRUs was $554. The table below sets forth the assumptions used to value the awards and the estimated grant-date fair value: | |||||||||||||||||
Risk-free interest rate | 0.61 | % | |||||||||||||||
Dividend yield | 0 | % | |||||||||||||||
Expected volatility | 55.66 | % | |||||||||||||||
Remaining performance period (years) | 1.86 | ||||||||||||||||
Estimated fair value per share of rTSRUs granted | $ | 26.51 | |||||||||||||||
The fair value related to the rTSRUs will be recorded as compensation expense over the period from date of grant to December 2016 regardless of whether the target relative total shareholder returns are reached. | |||||||||||||||||
The Company recorded stock-based compensation expense for the three and six months ended March 31, 2015 and 2014 in the following expense categories: | |||||||||||||||||
Three Months Ended | Six Months Ended | ||||||||||||||||
March 31, | March 31, | ||||||||||||||||
2015 | 2014 | 2015 | 2014 | ||||||||||||||
Research and development | $ | 396 | $ | 228 | $ | 637 | $ | 366 | |||||||||
General and administrative | 1,034 | 524 | 1,820 | 745 | |||||||||||||
$ | 1,430 | $ | 752 | $ | 2,457 | $ | 1,111 | ||||||||||
As of March 31, 2015, the Company had an aggregate of $18,488 of unrecognized stock-based compensation cost, which is expected to be recognized over a weighted average period of 3.1 years. | |||||||||||||||||
Employee Stock Purchase Plan | |||||||||||||||||
Under the Employee Stock Purchase Plan (the “ESPP”), a total of 185,614 shares of common stock were reserved for issuance. As of March 31, 2015, the Company has not commenced any offering under the ESPP and no shares have been issued. |
Net_Income_Loss_Per_Share
Net Income (Loss) Per Share | 6 Months Ended | ||||||||||||||||
Mar. 31, 2015 | |||||||||||||||||
Earnings Per Share [Abstract] | |||||||||||||||||
Net Income (Loss) Per Share | 9 | Net Income (Loss) Per Share | |||||||||||||||
Basic and diluted net income (loss) per share attributable to common stockholders was calculated as follows for the three and six months ended March 31, 2015 and 2014: | |||||||||||||||||
Three Months Ended | Six Months Ended | ||||||||||||||||
March 31, | March 31, | ||||||||||||||||
2015 | 2014 | 2015 | 2014 | ||||||||||||||
Basic net income (loss) per share: | |||||||||||||||||
Numerator: | |||||||||||||||||
Net income (loss) | $ | 28,753 | $ | (5,203 | ) | $ | 70,762 | $ | (10,573 | ) | |||||||
Denominator: | |||||||||||||||||
Weighted average common shares outstanding—basic | 18,679,898 | 18,353,628 | 18,641,060 | 18,149,330 | |||||||||||||
Net income (loss) per share—basic | $ | 1.54 | $ | (0.28 | ) | $ | 3.8 | $ | (0.58 | ) | |||||||
Diluted net income (loss) per share: | |||||||||||||||||
Numerator: | |||||||||||||||||
Net income (loss) | $ | 28,753 | $ | (5,203 | ) | $ | 70,762 | $ | (10,573 | ) | |||||||
Denominator: | |||||||||||||||||
Weighted average common shares outstanding—basic | 18,679,898 | 18,353,628 | 18,641,060 | 18,149,330 | |||||||||||||
Dilutive effect of common stock equivalents | 588,667 | — | 634,909 | — | |||||||||||||
Weighted average common shares outstanding—diluted | 19,268,565 | 18,353,628 | 19,275,969 | 18,149,330 | |||||||||||||
Net income (loss) per share—diluted | $ | 1.49 | $ | (0.28 | ) | $ | 3.67 | $ | (0.58 | ) | |||||||
Stock options for the purchase of 696,445 and 1,505,947 weighted average shares were excluded from the computation of diluted net income per share for the three months ended March 31, 2015 and March 31, 2014, respectively, because those options had an anti-dilutive impact due to either the net loss attributable to common stockholders incurred for the period or to the assumed proceeds per share using the treasury stock method being greater than the average fair value of the Company’s common shares for those periods. | |||||||||||||||||
Stock options for the purchase of 489,123 and 1,583,885 weighted average shares were excluded from the computation of diluted net income per share for the six months ended March 31, 2015 and March 31, 2014, respectively, because those options had an anti-dilutive impact due to either the net loss attributable to common stockholders incurred for the period or to the assumed proceeds per share using the treasury stock method being greater than the average fair value of the Company’s common shares for those periods. |
Income_Taxes
Income Taxes | 6 Months Ended | |
Mar. 31, 2015 | ||
Income Tax Disclosure [Abstract] | ||
Income Taxes | 10 | Income Taxes |
For the three months ended March 31, 2015 and March 31, 2014, the Company recorded an income tax provisions of $20,018 and $0, respectively, representing effective tax rates of 41.0% and 0.0%, respectively. The income tax provision for the three months ended March 31, 2015 was attributable to the federal and state taxes provided on the earnings of the Company’s operations, all of which are domestic. During the three months ended March 31, 2015, the gross deferred tax assets decreased by $434 primarily as a result of the utilization of net operating losses due to income before income taxes generated during the period. No provision for income tax was recorded for the three months ended March 31, 2014, as the Company maintained a valuation allowance against its deferred tax assets. The valuation allowance was released during the three months ended June 30, 2014. | ||
For the six months ended March 31, 2015 and March 31, 2014, the Company recorded an income tax provision of $48,520 and $0, respectively. During the six months ended March 31, 2015, the gross deferred tax assets decreased by $10,002 primarily as a result of the utilization of net operating losses due to income before income taxes generated during the period. No provision for income tax was recorded for the six months ended March 31, 2014, as the Company maintained a valuation allowance against its deferred tax assets. | ||
The Company files tax returns as prescribed by the tax laws of the jurisdictions in which it operates. In the normal course of business, the Company is subject to examination by federal and state jurisdictions, where applicable. There are currently no pending income tax examinations. The Company’s tax years are still open under statute from 2007 to the present. Earlier years may be examined to the extent that tax credit or net operating loss carryforwards are used in future periods. | ||
The Company had no unrecognized tax benefits as of March 31, 2015 or September 30, 2014. Unrecognized tax benefits represent tax positions for which reserves have been established. The Company’s policy is to record interest and penalties related to uncertain tax positions as part of its income tax provision. |
Commitments_and_Contingencies
Commitments and Contingencies | 6 Months Ended | ||||
Mar. 31, 2015 | |||||
Commitments and Contingencies Disclosure [Abstract] | |||||
Commitments and Contingencies | 11 | Commitments and Contingencies | |||
Leases | |||||
In March 2015 the Company amended its lease of office and laboratory space to expand the rented space and extend the lease term beginning in the fourth fiscal quarter of 2015. As amended, the lease expires in September 2022. Payment escalation as specified in the lease agreement is accrued such that rent expense is recognized on a straight-line basis over the term of occupancy. The Company recorded rent expense of $243 and $237 for the three months ended March 31, 2015 and 2014, respectively, and $480 and $474 for the six months ended March 31, 2015 and 2014, respectively. | |||||
Future minimum lease payments for operating leases as of March 31, 2015 are as follows: | |||||
Year ending September 30, | |||||
2015 | $ | 637 | |||
2016 | 1,958 | ||||
2017 | 2,010 | ||||
2018 | 2,062 | ||||
2019 | 2,117 | ||||
Thereafter | 6,493 | ||||
Total | $ | 15,277 | |||
In connection with the lease, the Company has outstanding a $608 and $436 letter of credit, collateralized by a money market account, as of March 31, 2015 and September 30, 2014, respectively. The Company classified such amounts as restricted cash. | |||||
Intellectual Property Licenses | |||||
The Company has a non-exclusive intellectual property license agreement with a third party, under which the Company is required to pay $200 in fiscal 2015 and (1) annual maintenance fees of $105 for each year that the agreement remains in effect, commencing on the first anniversary of the agreement, in order to maintain the right to use the license, and (2) a one-time fee of $50 in each circumstance in which the Company provides the licensed intellectual property to one of its collaborators with the prior consent of the licensor. | |||||
The Company also has a non-exclusive license with respect to patents it uses in its HCV research. Under the license, the Company is obligated to pay milestones totaling up to $5,000, plus low single digit royalties, for the development and regulatory approval of each HCV product outside of the Company’s collaboration with AbbVie and any other collaboration it may enter into in the future with a partner that has already licensed these patents. | |||||
Litigation and Contingencies Related to Use of Intellectual Property | |||||
From time to time, the Company may become subject to legal proceedings, claims and litigation arising in the ordinary course of business. The Company currently is not a party to any threatened or pending litigation. However, third parties might allege that the Company or its collaborators are infringing their patent rights or that the Company is otherwise violating their intellectual property rights. Such third parties may resort to litigation against the Company or its collaborators, which the Company has agreed to indemnify. With respect to some of these patents, the Company expects that it will be required to obtain licenses and could be required to pay license fees or royalties, or both. These licenses may not be available on acceptable terms, or at all. A costly license, or inability to obtain a necessary license, could have a material adverse effect on the Company’s financial condition, results of operations or cash flows. The Company accrues contingent liabilities when it is probable that future expenditures will be made and such expenditures can be reasonably estimated. |
Summary_of_Significant_Account1
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Mar. 31, 2015 | |
Accounting Policies [Abstract] | |
Use of Estimates | Use of Estimates |
The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements, and the reported amounts of revenues and expenses during the reporting period. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, valuation of warrants, Series 1 nonconvertible preferred stock and stock-based awards; the useful lives of property and equipment; and the accounting for income taxes, including uncertain tax positions. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Actual results could differ from the Company’s estimates. | |
Revenue Recognition | Revenue Recognition |
The Company’s revenue has been generated primarily through collaborative research and license agreements. The terms of these agreements contain multiple deliverables, which may include (i) licenses, (ii) research and development activities, and (iii) participation in joint research and development steering committees. The terms of these agreements may include nonrefundable upfront license fees, payments for research and development activities, payments based upon the achievement of certain milestones, and royalty payments based on product sales derived from the collaboration. In all instances, revenue is recognized only when the price is fixed or determinable, persuasive evidence of an arrangement exists, delivery has occurred or the services have been rendered, collectibility of the resulting receivable is reasonably assured, and the Company has fulfilled its performance obligations under the contract. | |
For agreements entered into prior to October 1, 2011, the Company evaluated license agreements with multiple deliverables to determine if the deliverable elements could be recognized separately by considering (i) if the delivered elements (typically the license) had standalone value to the customer, (ii) if the fair value of any undelivered elements (typically the research and development services and the steering committee activities) could be determined based on vendor-specific objective evidence (“VSOE”) or vendor objective evidence (“VOE”), and (iii) if the arrangement included a general right of return relative to the delivered item, the delivery or performance of the undelivered item was considered probable and substantially within the control of the Company. VSOE of fair value was based on the consistent price of a deliverable when the Company regularly sold it on a standalone basis. Alternatively, VOE was based upon third-party objective evidence of fair value. If the delivered elements had value on a standalone basis and the fair value of the undelivered elements could be determined based on VSOE or VOE, revenues of such elements were then accounted for separately as delivered with arrangement consideration allocated to the delivered elements based on the residual value method. If either (i) the delivered elements were considered to not have standalone value or (ii) VSOE or VOE of fair value for any of the undelivered elements could not be determined, the arrangement was accounted for as a single unit of accounting and all payments received were recognized as revenue over the estimated period of performance of the entire arrangement. | |
On October 1, 2011, the Company adopted Accounting Standards Update (“ASU”) No. 2009-13, Multiple-Deliverable Revenue Arrangements (“ASU 2009-13”). This guidance, which applies to multiple-element arrangements entered into or materially modified on or after October 1, 2011, amends the criteria for separating and allocating consideration in a multiple-element arrangement by modifying the fair value requirements for revenue recognition and eliminating the use of the residual value method. The selling prices of deliverables under the arrangement may be derived using third-party evidence (“TPE”) or a best estimate of selling price (“BESP”), if VSOE is not available. The objective of BESP is to determine the price at which the Company would transact a sale if the element within the license agreement was sold on a standalone basis. Establishing BESP involves management’s judgment and considers multiple factors, including market conditions and company-specific factors including those factors contemplated in negotiating the agreements as well as internally developed models that include assumptions related to market opportunity, discounted cash flows, estimated development costs, probability of success, and the time needed to commercialize a product candidate pursuant to the license. In validating the Company’s BESP, the Company considers whether changes in key assumptions used to determine the BESP will have a significant effect on the allocation of the arrangement consideration between the multiple deliverables. Deliverables under the arrangement are separate units of accounting if (i) the delivered item has value to the customer on a standalone basis, and (ii) if the arrangement includes a general right of return relative to the delivered item, delivery or performance of the undelivered item is considered probable and substantially within the control of the Company. The arrangement consideration that is fixed or determinable at the inception of the arrangement is allocated to the separate units of accounting based on their relative selling prices. The appropriate revenue recognition model is applied to each element, and revenue is accordingly recognized as each element is delivered. The Company may exercise significant judgment in determining whether a deliverable is a separate unit of accounting. The Company elected to adopt ASU 2009-13 prospectively as of October 1, 2011. | |
In determining the separate units of accounting, the Company evaluates whether the license has standalone value to the collaborator based on consideration of the relevant facts and circumstances for each arrangement. Factors considered in this determination include the research and development capabilities of the collaborator and the availability of relevant research expertise in the marketplace. In addition, the Company considers whether or not (i) the collaborator can use the license for its intended purpose without the receipt of the remaining deliverables, (ii) the value of the license is dependent on the undelivered items, and (iii) the collaborator or other vendors can provide the undelivered items. | |
Under a collaborative research and license agreement, a steering committee is typically responsible for overseeing the general working relationships, determining the protocols to be followed in the research and development performed, and evaluating the results from the continued development of the product in order to determine the clinical studies to be performed. The Company evaluates whether its participation in joint research and development steering committees is a substantive obligation or whether the services are considered inconsequential or perfunctory. The Company’s participation on a steering committee is considered “participatory” and therefore accounted for as a separate element when the collaborator requires the participation of the Company to ensure all elements of an arrangement are maximized. Steering committee services that are considered participatory are combined with other research services or performance obligations required under an arrangement, if any, in determining the level of effort required in an arrangement and the period over which the Company expects to complete its aggregate performance obligations. Alternatively, the Company’s participation on a steering committee is considered “protective” and therefore not accounted for as a separate element in a case where the Company can exercise or control when to be involved at its own discretion. Factors the Company considers in determining if its participation in a joint steering committee is participating or protective include: (i) which party negotiated or requested the steering committee, (ii) how frequently the steering committee meets, (iii) whether or not there are any penalties or other recourse if the Company does not attend the steering committee meetings, (iv) which party has decision making authority on the steering committee, and (v) whether or not the collaborator has the requisite experience and expertise associated with the research and development of the licensed intellectual property. | |
For all periods presented, whenever the Company determines that an element is delivered over a period of time, revenue is recognized using either a proportional performance model or a straight-line model over the period of performance, which is typically the research and development term. Full-time equivalents (“FTEs”) are typically used as the measure of performance. At each reporting period, the Company reassesses its cumulative measure of performance and makes appropriate adjustments, if necessary. The Company recognizes revenue using the proportional performance model whenever the Company can make reasonably reliable estimates of the level of effort required to complete its performance obligations under an arrangement. Revenue recognized under the proportional performance model at each reporting period is determined by multiplying the total expected payments under the contract (excluding royalties and payments contingent upon achievement of milestones) by the ratio of the level of effort incurred to date to the estimated total level of effort required to complete the performance obligations under the arrangement. Revenue is limited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined using the proportional performance model as of each reporting period. Alternatively, if the Company cannot make reasonably reliable estimates of the level of effort required to complete its performance obligations under an arrangement, then revenue under the arrangement is recognized on a straight-line basis over the period expected to complete the Company’s performance obligations. If and when a contingent milestone payment is earned, the additional consideration to be received is allocated to the separate units of accounting in the arrangement based on their relative selling prices at the inception of the arrangement. Revenue is limited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined on a straight-line basis as of the period end date. If the Company cannot reasonably estimate when its performance obligation period ends, then revenue is deferred until the Company can reasonably estimate when the performance obligation period ends. | |
Royalty revenue is recognized based on contractual terms when reported sales are reliably measurable and collectibility is reasonably assured, provided that there are no performance obligations then remaining. | |
During the three and six months ended March 31, 2015 and 2014, the Company also generated revenue from a government contract, under which the Company is reimbursed for certain allowable costs for the funded project. Revenue from the government contract is recognized when the related service is performed. The related costs incurred by the Company under the government contract are included in research and development expenses in the statements of operations. | |
Amounts received prior to satisfying all revenue recognition criteria are recorded as deferred revenue in the accompanying consolidated balance sheets. Amounts not expected to be recognized as revenue within the next twelve months of the consolidated balance sheet date are classified as long-term deferred revenue. | |
In the event that a collaborative research and license agreement is terminated and the Company then has no further performance obligations, the Company recognizes as revenue any amounts that had not previously been recorded as revenue but were classified as deferred revenue at the date of such termination. | |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements |
In May, 2014, the Financial Accounting Standards Board (the “FASB”) issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606), which supersedes all existing revenue recognition requirements, including most industry-specific guidance. The new standard requires a company to recognize revenue when it transfers goods or services to customers in an amount that reflects the consideration that the company expects to receive for those goods or services. The new standard will be effective for the Company on October 1, 2017; however there is a pending proposal to delay the effective period by one year. The Company is currently evaluating the potential impact that Topic 606 may have on its financial position and results of operations. |
Fair_Value_of_Financial_Assets1
Fair Value of Financial Assets and Liabilities (Tables) | 6 Months Ended | ||||||||||||||||
Mar. 31, 2015 | |||||||||||||||||
Fair Value Disclosures [Abstract] | |||||||||||||||||
Financial Assets and Liabilities that were Subject to Fair Value Measurement on Recurring Basis | The following tables present information about the Company’s financial assets and liabilities that were subject to fair value measurement on a recurring basis as of March 31, 2015 and September 30, 2014 and indicate the fair value hierarchy of the valuation inputs utilized to determine such fair value: | ||||||||||||||||
Fair Value Measurements as of March 31, 2015 Using: | |||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | ||||||||||||||
Assets: | |||||||||||||||||
Money market fund | $ | 22,364 | $ | — | $ | — | $ | 22,364 | |||||||||
Commercial paper | — | 12,484 | — | 12,484 | |||||||||||||
Corporate bonds | — | 156,003 | — | 156,003 | |||||||||||||
U.S. Agency bonds | — | 32,564 | — | 32,564 | |||||||||||||
$ | 22,364 | $ | 201,051 | $ | — | $ | 223,415 | ||||||||||
Liabilities: | |||||||||||||||||
Warrant liability | $ | — | $ | — | $ | 1,442 | $ | 1,442 | |||||||||
Series 1 nonconvertible preferred stock | — | — | 185 | 185 | |||||||||||||
$ | — | $ | — | $ | 1,627 | $ | 1,627 | ||||||||||
Fair Value Measurements as of September 30, 2014 Using: | |||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | ||||||||||||||
Assets: | |||||||||||||||||
Money market fund | $ | 30,239 | $ | — | $ | — | $ | 30,239 | |||||||||
Commercial paper | — | 7,499 | — | 7,499 | |||||||||||||
Corporate bonds | — | 88,056 | — | 88,056 | |||||||||||||
U.S. Agency bonds | — | 5,513 | — | 5,513 | |||||||||||||
$ | 30,239 | $ | 101,068 | $ | — | $ | 131,307 | ||||||||||
Liabilities: | |||||||||||||||||
Warrant liability | $ | — | $ | — | $ | 1,584 | $ | 1,584 | |||||||||
Series 1 nonconvertible preferred stock | — | — | 202 | 202 | |||||||||||||
$ | — | $ | — | $ | 1,786 | $ | 1,786 | ||||||||||
Fair Value Measurements of the Company's Warrant Liability and Series 1 Nonconvertible Preferred Stock | The recurring Level 3 fair value measurements of the Company’s warrant liability and Series 1 nonconvertible preferred stock using probability-weighted discounted cash flow include the following significant unobservable inputs: | ||||||||||||||||
Unobservable Input | Range | ||||||||||||||||
(Weighted | |||||||||||||||||
Average) | |||||||||||||||||
Warrant liability and Series 1 nonconvertible preferred stock | Probabilities of payout | 10% - 55% | |||||||||||||||
Periods in which payout is expected to occur | 2016 – 2017 | ||||||||||||||||
Discount rate | 4.25% | ||||||||||||||||
Rollforward of Aggregate Fair Values of Warrants | The following table provides a rollforward of the aggregate fair values of the Company’s warrants for the purchase of Series 1 nonconvertible preferred stock and the outstanding Series 1 nonconvertible preferred stock for which fair value is determined by Level 3 inputs: | ||||||||||||||||
Warrant | Series 1 | ||||||||||||||||
liability | nonconvertible | ||||||||||||||||
preferred | |||||||||||||||||
stock | |||||||||||||||||
Balance, September 30, 2014 | $ | 1,584 | $ | 202 | |||||||||||||
Decrease in fair value | (142 | ) | (17 | ) | |||||||||||||
Balance, March 31, 2015 | $ | 1,442 | $ | 185 | |||||||||||||
Marketable_Securities_Tables
Marketable Securities (Tables) | 6 Months Ended | ||||||||||||||||
Mar. 31, 2015 | |||||||||||||||||
Investments, Debt and Equity Securities [Abstract] | |||||||||||||||||
Fair Value of Available-for-Sale Marketable Securities by Type of Security | As of March 31, 2015 and September 30, 2014, the fair value of available-for-sale marketable securities by type of security was as follows: | ||||||||||||||||
March 31, 2015 | |||||||||||||||||
Amortized Cost | Gross Unrealized | Gross Unrealized | Fair Value | ||||||||||||||
Gains | Losses | ||||||||||||||||
Commercial paper | $ | 12,484 | $ | — | $ | — | $ | 12,484 | |||||||||
Corporate bonds | 155,984 | 98 | (79 | ) | 156,003 | ||||||||||||
U.S. Agency bonds | 32,542 | 22 | — | 32,564 | |||||||||||||
$ | 201,010 | $ | 120 | $ | (79 | ) | $ | 201,051 | |||||||||
September 30, 2014 | |||||||||||||||||
Amortized Cost | Gross Unrealized | Gross Unrealized | Fair Value | ||||||||||||||
Gains | Losses | ||||||||||||||||
Commercial paper | $ | 7,499 | $ | — | $ | — | $ | 7,499 | |||||||||
Corporate bonds | 88,156 | 14 | (114 | ) | 88,056 | ||||||||||||
U.S. Agency bonds | 5,513 | — | — | 5,513 | |||||||||||||
$ | 101,168 | $ | 14 | $ | (114 | ) | $ | 101,068 | |||||||||
Accrued_Expenses_and_Other_Lon1
Accrued Expenses and Other Long-Term Liabilities (Tables) | 6 Months Ended | ||||||||
Mar. 31, 2015 | |||||||||
Payables and Accruals [Abstract] | |||||||||
Accrued Expenses (Current) and Other Long-Term Liabilities | Accrued expenses (current) and other long-term liabilities consisted of the following as of March 31, 2015 and September 30, 2014: | ||||||||
March 31, | September 30, | ||||||||
2015 | 2014 | ||||||||
Accrued expenses: | |||||||||
Accrued payroll and related expenses | $ | 683 | $ | 1,275 | |||||
Accrued preclinical and clinical expenses | 517 | 493 | |||||||
Accrued vendor manufacturing expenses | 563 | 116 | |||||||
Accrued third-party license fees | 196 | 240 | |||||||
Accrued professional fees | 328 | 436 | |||||||
Accrued other | 623 | 312 | |||||||
$ | 2,910 | $ | 2,872 | ||||||
Other long-term liabilities: | |||||||||
Accrued rent expense | $ | 161 | $ | 153 | |||||
Asset retirement obligation | 91 | 76 | |||||||
$ | 252 | $ | 229 | ||||||
StockBased_Awards_Tables
Stock-Based Awards (Tables) | 6 Months Ended | ||||||||||||||||
Mar. 31, 2015 | |||||||||||||||||
Data Used to Determine Value of Stock Option Grants, Presented on Weighted Average Basis | The relevant data used to determine the value of the stock option grants is as follows, presented on a weighted average basis: | ||||||||||||||||
Three Months Ended March 31, | Six Months Ended March 31, | ||||||||||||||||
2015 | 2014 | 2015 | 2014 | ||||||||||||||
Risk-free interest rate | 1.65 | % | 1.93 | % | 1.85 | % | 1.9 | % | |||||||||
Expected term (in years) | 5.73 | 6.07 | 6.01 | 6.09 | |||||||||||||
Expected volatility | 72 | % | 77 | % | 75 | % | 74 | % | |||||||||
Expected dividend yield | 0 | % | 0 | % | 0 | % | 0 | % | |||||||||
Stock Option Activity | The following table summarizes stock option activity during the six months ended March 31, 2015: | ||||||||||||||||
Shares | Weighted | Weighted | Aggregate | ||||||||||||||
Issuable | Average | Average | Intrinsic | ||||||||||||||
Under | Exercise | Remaining | Value | ||||||||||||||
Options | Price | Contractual | |||||||||||||||
Term | |||||||||||||||||
(in years) | |||||||||||||||||
Outstanding as of September 30, 2014 | 1,389,437 | $ | 15.39 | 7.2 | $ | 33,573 | |||||||||||
Granted | 408,455 | 42.24 | |||||||||||||||
Exercised | (95,821 | ) | 3.54 | ||||||||||||||
Expired | (8,625 | ) | 20.73 | ||||||||||||||
Outstanding as of March 31, 2015 | 1,693,446 | $ | 22.51 | 7.5 | $ | 19,109 | |||||||||||
Options vested and expected to vest as of March 31, 2015 | 1,507,790 | $ | 23.26 | 7.5 | $ | 11,787 | |||||||||||
Options exercisable as of March 31, 2015 | 729,603 | $ | 11.04 | 5.6 | $ | 14,658 | |||||||||||
Stock-Based Compensation Expense | The Company recorded stock-based compensation expense for the three and six months ended March 31, 2015 and 2014 in the following expense categories: | ||||||||||||||||
Three Months Ended | Six Months Ended | ||||||||||||||||
March 31, | March 31, | ||||||||||||||||
2015 | 2014 | 2015 | 2014 | ||||||||||||||
Research and development | $ | 396 | $ | 228 | $ | 637 | $ | 366 | |||||||||
General and administrative | 1,034 | 524 | 1,820 | 745 | |||||||||||||
$ | 1,430 | $ | 752 | $ | 2,457 | $ | 1,111 | ||||||||||
Total Shareholder Return Units TSRU [Member] | |||||||||||||||||
Data Used to Determine Value of Stock Option Grants, Presented on Weighted Average Basis | The table below sets forth the assumptions used to value the awards and the estimated grant-date fair value: | ||||||||||||||||
Risk-free interest rate | 0.61 | % | |||||||||||||||
Dividend yield | 0 | % | |||||||||||||||
Expected volatility | 55.66 | % | |||||||||||||||
Remaining performance period (years) | 1.86 | ||||||||||||||||
Estimated fair value per share of rTSRUs granted | $ | 26.51 |
Net_Income_Loss_Per_Share_Tabl
Net Income (Loss) Per Share (Tables) | 6 Months Ended | ||||||||||||||||
Mar. 31, 2015 | |||||||||||||||||
Earnings Per Share [Abstract] | |||||||||||||||||
Basic and Diluted Net Income (Loss) Per Share Attributable to Common Stockholders | Basic and diluted net income (loss) per share attributable to common stockholders was calculated as follows for the three and six months ended March 31, 2015 and 2014: | ||||||||||||||||
Three Months Ended | Six Months Ended | ||||||||||||||||
March 31, | March 31, | ||||||||||||||||
2015 | 2014 | 2015 | 2014 | ||||||||||||||
Basic net income (loss) per share: | |||||||||||||||||
Numerator: | |||||||||||||||||
Net income (loss) | $ | 28,753 | $ | (5,203 | ) | $ | 70,762 | $ | (10,573 | ) | |||||||
Denominator: | |||||||||||||||||
Weighted average common shares outstanding—basic | 18,679,898 | 18,353,628 | 18,641,060 | 18,149,330 | |||||||||||||
Net income (loss) per share—basic | $ | 1.54 | $ | (0.28 | ) | $ | 3.8 | $ | (0.58 | ) | |||||||
Diluted net income (loss) per share: | |||||||||||||||||
Numerator: | |||||||||||||||||
Net income (loss) | $ | 28,753 | $ | (5,203 | ) | $ | 70,762 | $ | (10,573 | ) | |||||||
Denominator: | |||||||||||||||||
Weighted average common shares outstanding—basic | 18,679,898 | 18,353,628 | 18,641,060 | 18,149,330 | |||||||||||||
Dilutive effect of common stock equivalents | 588,667 | — | 634,909 | — | |||||||||||||
Weighted average common shares outstanding—diluted | 19,268,565 | 18,353,628 | 19,275,969 | 18,149,330 | |||||||||||||
Net income (loss) per share—diluted | $ | 1.49 | $ | (0.28 | ) | $ | 3.67 | $ | (0.58 | ) | |||||||
Commitments_and_Contingencies_
Commitments and Contingencies (Tables) | 6 Months Ended | ||||
Mar. 31, 2015 | |||||
Commitments and Contingencies Disclosure [Abstract] | |||||
Future Minimum Lease Payments for Operating Leases | Future minimum lease payments for operating leases as of March 31, 2015 are as follows: | ||||
Year ending September 30, | |||||
2015 | $ | 637 | |||
2016 | 1,958 | ||||
2017 | 2,010 | ||||
2018 | 2,062 | ||||
2019 | 2,117 | ||||
Thereafter | 6,493 | ||||
Total | $ | 15,277 | |||
Fair_Value_of_Financial_Assets2
Fair Value of Financial Assets and Liabilities - Financial Assets and Liabilities that were Subject to Fair Value Measurement on Recurring Basis (Detail) (USD $) | Mar. 31, 2015 | Sep. 30, 2014 |
In Thousands, unless otherwise specified | ||
Assets: | ||
Available for sale securities, fair value | $201,051 | $101,068 |
Assets, Fair Value Disclosure, Total | 223,415 | 131,307 |
Liabilities: | ||
Liabilities, Fair Value Disclosure, Total | 1,627 | 1,786 |
Warrant Liability [Member] | ||
Liabilities: | ||
Liabilities | 1,442 | 1,584 |
Money Market Fund [Member] | ||
Assets: | ||
Available for sale securities, fair value | 22,364 | 30,239 |
Commercial Paper [Member] | ||
Assets: | ||
Available for sale securities, fair value | 12,484 | 7,499 |
Corporate Bonds [Member] | ||
Assets: | ||
Available for sale securities, fair value | 156,003 | 88,056 |
U.S. Agency Bonds [Member] | ||
Assets: | ||
Available for sale securities, fair value | 32,564 | 5,513 |
Series 1 Nonconvertible Preferred Stock [Member] | ||
Liabilities: | ||
Liabilities | 185 | 202 |
Level 1 [Member] | ||
Assets: | ||
Assets, Fair Value Disclosure, Total | 22,364 | 30,239 |
Level 1 [Member] | Money Market Fund [Member] | ||
Assets: | ||
Available for sale securities, fair value | 22,364 | 30,239 |
Level 2 [Member] | ||
Assets: | ||
Assets, Fair Value Disclosure, Total | 201,051 | 101,068 |
Level 2 [Member] | Commercial Paper [Member] | ||
Assets: | ||
Available for sale securities, fair value | 12,484 | 7,499 |
Level 2 [Member] | Corporate Bonds [Member] | ||
Assets: | ||
Available for sale securities, fair value | 156,003 | 88,056 |
Level 2 [Member] | U.S. Agency Bonds [Member] | ||
Assets: | ||
Available for sale securities, fair value | 32,564 | 5,513 |
Level 3 [Member] | ||
Liabilities: | ||
Liabilities, Fair Value Disclosure, Total | 1,627 | 1,786 |
Level 3 [Member] | Warrant Liability [Member] | ||
Liabilities: | ||
Liabilities | 1,442 | 1,584 |
Level 3 [Member] | Series 1 Nonconvertible Preferred Stock [Member] | ||
Liabilities: | ||
Liabilities | $185 | $202 |
Fair_Value_of_Financial_Assets3
Fair Value of Financial Assets and Liabilities - Additional Information (Detail) (USD $) | 3 Months Ended | 6 Months Ended | |||
Mar. 31, 2015 | Mar. 31, 2014 | Mar. 31, 2015 | Mar. 31, 2014 | Sep. 30, 2014 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Transfers between Level 1, Level 2 and Level 3 | $0 | $0 | $0 | $0 | |
Series 1 Nonconvertible Preferred Stock [Member] | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Fair value of Series 1 nonconvertible preferred stock | 185,000 | 185,000 | 202,000 | ||
Warrant Liability [Member] | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Fair value of Series 1 nonconvertible preferred stock | $1,442,000 | $1,442,000 | $1,584,000 |
Fair_Value_of_Financial_Assets4
Fair Value of Financial Assets and Liabilities - Fair Value Measurements of the Company's Warrant Liability and Series 1 Nonconvertible Preferred Stock (Detail) (Warrant Liability [Member], Series 1 Nonconvertible Preferred Stock [Member]) | 6 Months Ended |
Mar. 31, 2015 | |
Fair Value Inputs, Liabilities, Quantitative Information [Line Items] | |
Periods in which payout is expected to occur, beginning | 2016 |
Periods in which payout is expected to occur, ending | 2017 |
Discount rate | 4.25% |
Minimum [Member] | |
Fair Value Inputs, Liabilities, Quantitative Information [Line Items] | |
Probabilities of payout | 10.00% |
Maximum [Member] | |
Fair Value Inputs, Liabilities, Quantitative Information [Line Items] | |
Probabilities of payout | 55.00% |
Fair_Value_of_Financial_Assets5
Fair Value of Financial Assets and Liabilities - Rollforward of Aggregate Fair Values of Warrants (Detail) (USD $) | 6 Months Ended |
In Thousands, unless otherwise specified | Mar. 31, 2015 |
Series 1 Nonconvertible Preferred Stock [Member] | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Beginning Balance | $202 |
Decrease in fair value | -17 |
Ending Balance | 185 |
Warrant Liability [Member] | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Beginning Balance | 1,584 |
Decrease in fair value | -142 |
Ending Balance | $1,442 |
Marketable_Securities_Fair_Val
Marketable Securities - Fair Value of Available-for-Sale Marketable Securities by Type of Security (Detail) (USD $) | Mar. 31, 2015 | Sep. 30, 2014 |
In Thousands, unless otherwise specified | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $201,010 | $101,168 |
Gross Unrealized Gains | 120 | 14 |
Gross Unrealized Losses | -79 | -114 |
Fair Value | 201,051 | 101,068 |
Commercial Paper [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 12,484 | 7,499 |
Fair Value | 12,484 | 7,499 |
Corporate Bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 155,984 | 88,156 |
Gross Unrealized Gains | 98 | 14 |
Gross Unrealized Losses | -79 | -114 |
Fair Value | 156,003 | 88,056 |
U.S. Agency Bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 32,542 | 5,513 |
Gross Unrealized Gains | 22 | |
Fair Value | $32,564 | $5,513 |
Marketable_Securities_Addition
Marketable Securities - Additional Information (Detail) (USD $) | 6 Months Ended | 12 Months Ended |
In Thousands, unless otherwise specified | Mar. 31, 2015 | Sep. 30, 2014 |
Schedule of Available-for-sale Securities [Line Items] | ||
Marketable securities maturing in greater than one year, aggregate fair value | 61,330 | 41,003 |
Short Term Marketable Securities [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Maturity period of the marketable securities | Within one year | Within one year |
Corporate Bond Securities [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Maturity period of the marketable securities | Within two years | Within three years |
U.S. Agency Bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Maturity period of the marketable securities | Within three years |
Accrued_Expenses_and_Other_Lon2
Accrued Expenses and Other Long-Term Liabilities - Accrued Expenses (Current) and Other Long-Term Liabilities (Detail) (USD $) | Mar. 31, 2015 | Sep. 30, 2014 |
In Thousands, unless otherwise specified | ||
Accrued expenses: | ||
Accrued payroll and related expenses | $683 | $1,275 |
Accrued preclinical and clinical expenses | 517 | 493 |
Accrued vendor manufacturing expenses | 563 | 116 |
Accrued third-party license fees | 196 | 240 |
Accrued professional fees | 328 | 436 |
Accrued other | 623 | 312 |
Accrued expenses | 2,910 | 2,872 |
Other long-term liabilities: | ||
Accrued rent expense | 161 | 153 |
Asset retirement obligation | 91 | 76 |
Other long-term liabilities | $252 | $229 |
Collaboration_Agreements_Addit
Collaboration Agreements - Additional Information (Detail) (USD $) | 1 Months Ended | 3 Months Ended | 6 Months Ended | 0 Months Ended | 12 Months Ended | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jan. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Mar. 31, 2015 | Mar. 31, 2015 | Mar. 31, 2015 | Sep. 30, 2014 | Feb. 28, 2015 | Mar. 31, 2014 | Mar. 31, 2014 | Sep. 30, 2011 | |
AbbVie [Member] | |||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||
Collaboration agreement date | 27-Nov-06 | ||||||||||
Collaboration agreement tiered royalty description | From the low double digits up to twenty percent, or on a blended basis from the low double digits up to the high teens, on net sales | ||||||||||
Upfront license payments, preferred stock sale proceeds, research funding, and milestone payments | $160,000,000 | ||||||||||
Milestone revenue recognized | 50,000,000 | 75,000,000 | 50,000,000 | 125,000,000 | |||||||
Royalty recognized | 6,961,000 | 8,353,000 | |||||||||
AbbVie [Member] | Additional Funding Agreement Terms [Member] | |||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||
Expected proceed from milestone payment | 80,000,000 | ||||||||||
AbbVie [Member] | JAPAN | |||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||
Expected proceed from milestone payment | 30,000,000 | ||||||||||
AbbVie [Member] | Paritaprevir 3-DAA Regimen [Member] | |||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||
Percentage of net sales to be allocated | 30.00% | ||||||||||
AbbVie [Member] | Paritaprevir 2-DAA Regimen [Member] | |||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||
Percentage of net sales to be allocated | 45.00% | ||||||||||
AbbVie [Member] | Abt 493 2-DAA Regimen [Member] | |||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||
Percentage of net sales to be allocated | 50.00% | ||||||||||
AbbVie [Member] | Abt 493 3-DAA Regimen [Member] | |||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||
Percentage of net sales to be allocated | 33.33% | ||||||||||
Novartis [Member] | |||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||
Future milestone payments | 0 | ||||||||||
National Institutes of Health, National Institute of Allergy and Infectious Diseases [Member] | |||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||
Collaboration agreement date | 30-Sep-11 | ||||||||||
Amended contract for development, amount | 21,000,000 | ||||||||||
Funding related to research and development | 23,500,000 | 23,500,000 | 23,500,000 | ||||||||
Revenue from grants | 406,000 | 1,512,000 | 2,160,000 | 3,053,000 | |||||||
National Institutes of Health, National Institute of Allergy and Infectious Diseases [Member] | Maximum [Member] | |||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||
Amended contract for development, amount | $42,700,000 | ||||||||||
Awarded contract for development, contract period | 5 years |
Warrants_to_Purchase_Series_1_1
Warrants to Purchase Series 1 Nonconvertible Preferred Stock and Series 1 Nonconvertible Preferred Stock - Additional Information (Detail) (USD $) | 0 Months Ended | 6 Months Ended | |||
In Thousands, except Share data, unless otherwise specified | Feb. 05, 2014 | Mar. 31, 2015 | Sep. 30, 2014 | Nov. 30, 2010 | Oct. 31, 2010 |
Series 1 Nonconvertible Preferred Stock [Member] | |||||
Class of Warrant or Right [Line Items] | |||||
Number of shares issuable upon exercise of the warrants | 1,999,989 | 1,999,989 | |||
Warrant expiration date | 4-Oct-17 | ||||
Warrant exercised | 225,408 | ||||
Warrants issuance | 223,153 | ||||
Fair value of Series 1 nonconvertible preferred stock | $185 | $202 | |||
Warrant Liability [Member] | |||||
Class of Warrant or Right [Line Items] | |||||
Fair value of Series 1 nonconvertible preferred stock | $1,442 | $1,584 |
StockBased_Awards_Additional_I
Stock-Based Awards - Additional Information (Detail) (USD $) | 0 Months Ended | 6 Months Ended | 1 Months Ended | 3 Months Ended | ||
Mar. 31, 2015 | Mar. 31, 2015 | Mar. 31, 2013 | Mar. 31, 2015 | Mar. 31, 2014 | Oct. 01, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Options granted to executives | 408,455 | |||||
Aggregate of unrecognized stock-based compensation cost | $18,488,000 | $18,488,000 | $18,488,000 | |||
Weighted average recognition period | 3 years 1 month 6 days | |||||
Common stock reserved | 185,614 | 185,614 | 185,614 | |||
Shares issued under the ESPP | 0 | |||||
Performance Share Units [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Options granted to executives | 20,900 | |||||
Compensation expenses | 0 | |||||
Performance Share Units [Member] | Minimum [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of shares range percentage | 0.00% | |||||
Fair value of performance shares units | 0 | |||||
Performance Share Units [Member] | Maximum [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of shares range percentage | 200.00% | |||||
Fair value of performance shares units | 1,501 | |||||
Total Shareholder Return Units TSRU [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Options granted to executives | 20,900 | |||||
Fair value of options at the grant date | 554,000 | |||||
Total Shareholder Return Units TSRU [Member] | Minimum [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of shares range percentage | 0.00% | |||||
Total Shareholder Return Units TSRU [Member] | Maximum [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of shares range percentage | 200.00% | |||||
Executive Officer [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Options granted to executives | 41,800 | 167,052 | ||||
Fair value of options at the grant date | 2,479,000 | |||||
Compensation expenses | $0 | $0 | $206,000 | |||
2012 Equity Incentive Plan [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Common stock shares authorized | 557,863 | |||||
Percentage of potential common stock shares to be issued | 3.00% | |||||
Potential number of common stock shares to be issued | 2,088,167 | |||||
Shares available for future grant | 529,176 | 529,176 | 529,176 |
StockBased_Awards_Data_Used_to
Stock-Based Awards - Data Used to Determine Value of Stock Option Grants, Presented on Weighted Average Basis (Detail) | 3 Months Ended | 6 Months Ended | ||
Mar. 31, 2015 | Mar. 31, 2014 | Mar. 31, 2015 | Mar. 31, 2014 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ||||
Risk-free interest rate | 1.65% | 1.93% | 1.85% | 1.90% |
Expected term (in years) | 5 years 8 months 23 days | 6 years 26 days | 6 years 4 days | 6 years 1 month 2 days |
Expected volatility | 72.00% | 77.00% | 75.00% | 74.00% |
Expected dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
StockBased_Awards_Stock_Option
Stock-Based Awards - Stock Option Activity (Detail) (USD $) | 0 Months Ended | 6 Months Ended |
In Thousands, except Share data, unless otherwise specified | Sep. 30, 2014 | Mar. 31, 2015 |
Shares Issuable Under Options | ||
Outstanding as of beginning of period | 1,389,437 | 1,389,437 |
Granted | 408,455 | |
Exercised | -95,821 | |
Expired | -8,625 | |
Outstanding as of end of period | 1,693,446 | |
Options vested and expected to vest as of end of period | 1,507,790 | |
Options exercisable as of end of period | 729,603 | |
Weighted Average Exercise Price | ||
Outstanding as of beginning of period | $15.39 | $15.39 |
Granted | $42.24 | |
Exercised | $3.54 | |
Expired | $20.73 | |
Outstanding as of ending balance | $22.51 | |
Options vested and expected to vest as of end of period | $23.26 | |
Options exercisable as of end of period | $11.04 | |
Weighted Average Remaining Contractual Term (In years) | ||
Outstanding as of end of period | 7 years 2 months 12 days | 7 years 6 months |
Options vested and expected to vest as of end period | 7 years 6 months | |
Options exercisable as of end of period | 5 years 7 months 6 days | |
Aggregate Intrinsic Value | ||
Outstanding as of beginning of period | $33,573 | $33,573 |
Outstanding as of end of period | 19,109 | |
Options vested and expected to vest as of end of period | 11,787 | |
Options exercisable as of end of period | $14,658 |
StockBased_Awards_Weighted_Ave
Stock-Based Awards - Weighted Average Assumptions Used To Value Awards and Estimated Grant Date Fair Value (Detail) (USD $) | 3 Months Ended | 6 Months Ended | ||
Mar. 31, 2015 | Mar. 31, 2014 | Mar. 31, 2015 | Mar. 31, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Risk-free interest rate | 1.65% | 1.93% | 1.85% | 1.90% |
Dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Expected volatility | 72.00% | 77.00% | 75.00% | 74.00% |
Remaining performance period (years) | 5 years 8 months 23 days | 6 years 26 days | 6 years 4 days | 6 years 1 month 2 days |
Total Shareholder Return Units TSRU [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Risk-free interest rate | 0.61% | |||
Dividend yield | 0.00% | |||
Expected volatility | 55.66% | |||
Remaining performance period (years) | 1 year 10 months 10 days | |||
Estimated fair value per share of rTSRUs granted | 26.51 |
StockBased_Awards_StockBased_C
Stock-Based Awards - Stock-Based Compensation Expense (Detail) (USD $) | 3 Months Ended | 6 Months Ended | ||
In Thousands, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 | Mar. 31, 2015 | Mar. 31, 2014 |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | $1,430 | $752 | $2,457 | $1,111 |
Research and Development [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | 396 | 228 | 637 | 366 |
General and Administrative [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | $1,034 | $524 | $1,820 | $745 |
Net_Income_Loss_Per_Share_Basi
Net Income (Loss) Per Share - Basic and Diluted Net Income (Loss) Per Share Attributable to Common Stockholders (Detail) (USD $) | 3 Months Ended | 6 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 | Mar. 31, 2015 | Mar. 31, 2014 |
Basic net income (loss) per share: | ||||
Net income (loss) | $28,753 | ($5,203) | $70,762 | ($10,573) |
Weighted average common shares outstanding-basic | 18,679,898 | 18,353,628 | 18,641,060 | 18,149,330 |
Net income (loss) per share-basic | $1.54 | ($0.28) | $3.80 | ($0.58) |
Diluted net income (loss) per share: | ||||
Net income (loss) | $28,753 | ($5,203) | $70,762 | ($10,573) |
Weighted average common shares outstanding-basic | 18,679,898 | 18,353,628 | 18,641,060 | 18,149,330 |
Dilutive effect of common stock equivalents | 588,667 | 634,909 | ||
Weighted average common shares outstanding-diluted | 19,268,565 | 18,353,628 | 19,275,969 | 18,149,330 |
Net income (loss) per share-diluted | $1.49 | ($0.28) | $3.67 | ($0.58) |
Net_Income_Loss_Per_Share_Addi
Net Income (Loss) Per Share - Additional Information (Detail) (Stock Option [Member]) | 3 Months Ended | 6 Months Ended | ||
Mar. 31, 2015 | Mar. 31, 2014 | Mar. 31, 2015 | Mar. 31, 2014 | |
Stock Option [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Shares excluded from the computation of diluted net income per share | 696,445 | 1,505,947 | 489,123 | 1,583,885 |
Income_Taxes_Additional_Inform
Income Taxes - Additional Information (Detail) (USD $) | 3 Months Ended | 6 Months Ended | |||
Mar. 31, 2015 | Mar. 31, 2014 | Mar. 31, 2015 | Mar. 31, 2014 | Sep. 30, 2014 | |
Income Tax Disclosure [Abstract] | |||||
Income tax provision | $20,018,000 | $0 | $48,520,000 | $0 | |
Effective income tax rates | 41.00% | 0.00% | |||
Gross deferred tax assets related to net operating loss carry forwards, Decrease | 434,000 | 10,002,000 | |||
Unrecognized tax benefits | $0 | $0 | $0 |
Commitments_and_Contingencies_1
Commitments and Contingencies - Additional Information (Detail) (USD $) | 3 Months Ended | 6 Months Ended | |||
In Thousands, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 | Mar. 31, 2015 | Mar. 31, 2014 | Sep. 30, 2014 |
Commitments And Contingencies [Line Items] | |||||
Rent expense | $243 | $237 | $480 | $474 | |
Office lease expiration period | Sep-22 | ||||
Outstanding letter of credit | 608 | 608 | 436 | ||
Maintenance fees | 105 | ||||
One-time fee | 50 | ||||
Company's obligation to pay | 5,000 | ||||
Fiscal Year 2015 [Member] | |||||
Commitments And Contingencies [Line Items] | |||||
License expense | $200 |
Commitments_and_Contingencies_2
Commitments and Contingencies - Future Minimum Lease Payments for Operating Leases (Detail) (USD $) | Mar. 31, 2015 |
In Thousands, unless otherwise specified | |
Commitments and Contingencies Disclosure [Abstract] | |
2015 | $637 |
2016 | 1,958 |
2017 | 2,010 |
2018 | 2,062 |
2019 | 2,117 |
Thereafter | 6,493 |
Total | $15,277 |