Document_and_Entity_Informatio
Document and Entity Information | 3 Months Ended | |
Mar. 31, 2014 | Apr. 24, 2014 | |
Document And Entity Information [Abstract] | ' | ' |
Document Type | '10-Q | ' |
Amendment Flag | 'false | ' |
Document Period End Date | 31-Mar-14 | ' |
Document Fiscal Year Focus | '2014 | ' |
Document Fiscal Period Focus | 'Q1 | ' |
Trading Symbol | 'DRRX | ' |
Entity Registrant Name | 'DURECT CORP | ' |
Entity Central Index Key | '0001082038 | ' |
Current Fiscal Year End Date | '--12-31 | ' |
Entity Filer Category | 'Accelerated Filer | ' |
Entity Common Stock, Shares Outstanding | ' | 110,522,882 |
Condensed_Balance_Sheets
Condensed Balance Sheets (USD $) | Mar. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Current assets: | ' | ' |
Cash and cash equivalents | $1,970 | $7,836 |
Short-term investments | 15,838 | 12,753 |
Accounts receivable (net of allowances of $197 at March 31, 2014 and $144 at December 31, 2013) | 2,108 | 2,349 |
Inventories | 3,510 | 3,502 |
Prepaid expenses and other current assets | 2,064 | 1,888 |
Total current assets | 25,490 | 28,328 |
Property and equipment (net of accumulated depreciation of $20,638 and $20,488 at March 31, 2014 and December 31, 2013, respectively) | 1,837 | 1,985 |
Goodwill | 6,399 | 6,399 |
Intangible assets, net | 13 | 18 |
Long-term investments | 3,611 | 3,352 |
Long-term restricted investments | 350 | 450 |
Other long-term assets | 288 | 288 |
Total assets | 37,988 | 40,820 |
Current liabilities: | ' | ' |
Accounts payable | 1,161 | 736 |
Accrued liabilities | 3,869 | 5,865 |
Contract research liabilities | 202 | 329 |
Deferred revenue, current portion | 255 | 255 |
Total current liabilities | 5,487 | 7,185 |
Deferred revenue, non-current portion | 1,232 | 1,296 |
Other long-term liabilities | 1,604 | 1,618 |
Commitments and contingencies | ' | ' |
Stockholders' equity: | ' | ' |
Preferred stock | ' | ' |
Common stock | 11 | 11 |
Additional paid-in capital | 394,044 | 391,504 |
Accumulated other comprehensive income | 5 | 1 |
Accumulated deficit | -364,395 | -360,795 |
Stockholders' equity | 29,665 | 30,721 |
Total liabilities and stockholders' equity | $37,988 | $40,820 |
Condensed_Balance_Sheets_Paren
Condensed Balance Sheets (Parenthetical) (USD $) | Mar. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Statement Of Financial Position [Abstract] | ' | ' |
Allowances for accounts receivable | $197 | $144 |
Accumulated depreciation on property and equipment | $20,638 | $20,488 |
Condensed_Statements_of_Compre
Condensed Statements of Comprehensive Loss (USD $) | 3 Months Ended | |
In Thousands, except Per Share data, unless otherwise specified | Mar. 31, 2014 | Mar. 31, 2013 |
Income Statement [Abstract] | ' | ' |
Collaborative research and development and other revenue (see Note 2) | $3,512 | $913 |
Product revenue, net | 2,781 | 3,240 |
Total revenues | 6,293 | 4,153 |
Operating expenses: | ' | ' |
Cost of product revenues | 1,063 | 1,658 |
Research and development | 5,469 | 4,789 |
Selling, general and administrative | 3,363 | 2,901 |
Total operating expenses | 9,895 | 9,348 |
Loss from operations | -3,602 | -5,195 |
Other income (expense): | ' | ' |
Interest and other income (expenses) | 3 | 14 |
Interest expense | -1 | -2 |
Net other income (expense) | 2 | 12 |
Net loss | -3,600 | -5,183 |
Net loss per share | ' | ' |
Basic | ($0.03) | ($0.05) |
Diluted | ($0.03) | ($0.05) |
Weighted-average shares used in computing net loss per share | ' | ' |
Basic | 110,468 | 101,881 |
Diluted | 110,468 | 101,881 |
Total comprehensive loss | ($3,596) | ($5,181) |
Condensed_Statements_of_Cash_F
Condensed Statements of Cash Flows (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2014 | Mar. 31, 2013 |
Cash flows from operating activities | ' | ' |
Net loss | ($3,600) | ($5,183) |
Adjustments to reconcile net loss to net cash used in operating activities: | ' | ' |
Depreciation and amortization | 155 | 258 |
Stock-based compensation | 726 | 945 |
Changes in assets and liabilities: | ' | ' |
Accounts receivable | 241 | 599 |
Inventories | -9 | 341 |
Prepaid expenses and other assets | -176 | 449 |
Accounts payable | 425 | -952 |
Accrued and other liabilities | -285 | 626 |
Contract research liabilities | -127 | -60 |
Deferred revenue | -64 | -400 |
Total adjustments | 886 | 1,806 |
Net cash used in operating activities | -2,714 | -3,377 |
Cash flows from investing activities | ' | ' |
Purchases of property and equipment | -2 | -26 |
Purchases of available-for-sale securities | -6,060 | -5,382 |
Proceeds from maturities of available-for-sale securities | 2,820 | 5,840 |
Net cash (used in) provided by investing activities | -3,242 | 432 |
Cash flows from financing activities | ' | ' |
Payments on equipment financing obligations | -2 | -2 |
Net proceeds from issuances of common stock | 92 | 2 |
Net cash provided by financing activities | 90 | ' |
Net decrease in cash and cash equivalents | -5,866 | -2,945 |
Cash and cash equivalents, beginning of the period | 7,836 | 11,195 |
Cash and cash equivalents, end of the period | $1,970 | $8,250 |
Summary_of_Significant_Account
Summary of Significant Accounting Policies | 3 Months Ended | ||||||||
Mar. 31, 2014 | |||||||||
Accounting Policies [Abstract] | ' | ||||||||
Summary of Significant Accounting Policies | ' | ||||||||
Note 1. Summary of Significant Accounting Policies | |||||||||
Nature of Operations | |||||||||
DURECT Corporation (the Company) was incorporated in the state of Delaware on February 6, 1998. The Company is a pharmaceutical company developing therapies based on its proprietary drug formulations and delivery platform technologies. The Company has several products under development by itself and with third party collaborators. The Company also manufactures and sells osmotic pumps used in laboratory research, and designs, develops and manufactures a wide range of standard and custom biodegradable polymers and excipients for pharmaceutical and medical device clients for use as raw materials in their products. In addition, the Company conducts research and development of pharmaceutical products in collaboration with third party pharmaceutical and biotechnology companies. | |||||||||
Basis of Presentation | |||||||||
The accompanying unaudited financial statements include the accounts of the Company. These financial statements have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission (SEC), and therefore do not include all the information and footnotes necessary for a complete presentation of the Company’s results of operations, financial position and cash flows in conformity with U.S. generally accepted accounting principles (U.S. GAAP). The unaudited financial statements reflect all adjustments (consisting only of normal recurring adjustments) which are, in the opinion of management, necessary for a fair presentation of the financial position at March 31, 2014, the operating results and comprehensive loss for the three months ended March 31, 2014 and 2013, and cash flows for the three months ended March 31, 2014 and 2013. The balance sheet as of December 31, 2013 has been derived from audited financial statements at that date but does not include all of the information and footnotes required by U.S. GAAP for complete financial statements. These financial statements and notes should be read in conjunction with the Company’s audited financial statements and notes thereto, included in the Company’s annual report on Form 10-K for the fiscal year ended December 31, 2013 filed with the SEC. | |||||||||
The results of operations for the interim periods presented are not necessarily indicative of results that may be expected for any other interim period or for the full fiscal year. | |||||||||
Inventories | |||||||||
Inventories are stated at the lower of cost or market, with cost determined on a first-in, first-out basis. The Company’s inventories consisted of the following (in thousands): | |||||||||
March 31, | December 31, | ||||||||
2014 | 2013 | ||||||||
(unaudited) | |||||||||
Raw materials | $ | 1,348 | $ | 1,404 | |||||
Work in process | 1,371 | 1,063 | |||||||
Finished goods | 791 | 1,035 | |||||||
Total inventories | $ | 3,510 | $ | 3,502 | |||||
Revenue Recognition | |||||||||
Revenue from the sale of products is recognized when there is persuasive evidence that an arrangement exists, the product is shipped and title transfers to customers, provided no continuing obligation on the Company’s part exists, the price is fixed or determinable and the collectability of the amounts owed is reasonably assured. The Company enters into license and collaboration agreements under which it may receive upfront license fees, research funding and contingent milestone payments and royalties. The Company’s deliverables under these arrangements typically consist of granting licenses to intellectual property rights and providing research and development services. The accounting standards contain a presumption that separate contracts entered into at or near the same time with the same entity or related parties were negotiated as a package and should be evaluated as a single agreement. | |||||||||
Revenue on cost-plus-fee contracts, such as under contracts to perform research and development for others, is recognized as the related services are rendered as determined by the extent of reimbursable costs incurred plus estimated fees thereon. | |||||||||
Comprehensive Income (Loss) | |||||||||
Components of other comprehensive income (loss) are comprised entirely of unrealized gains and losses on the Company’s available-for-sale securities for all periods presented and are included in total comprehensive income (loss) as follows (in thousands). | |||||||||
Three months ended | |||||||||
March 31, | |||||||||
2014 | 2013 | ||||||||
Net loss | $ | (3,600 | ) | $ | (5,183 | ) | |||
Net change in unrealized gain on available-for-sale investments, net of tax | 4 | 2 | |||||||
Comprehensive loss | $ | (3,596 | ) | $ | (5,181 | ) | |||
The tax effect of the changes in accumulated other comprehensive income (loss) was immaterial for the periods presented. Accumulated other comprehensive income as of March 31, 2014 and December 31, 2013 is entirely comprised of net unrealized gains on available-for-sale securities. | |||||||||
Net Income (Loss) Per Share | |||||||||
Basic net income (loss) per share is calculated by dividing the net income (loss) by the weighted-average number of common shares outstanding. Diluted net income (loss) per share is computed using the weighted-average number of common shares outstanding and common stock equivalents (i.e., options to purchase common stock) outstanding during the period, if dilutive, using the treasury stock method for options and warrants. | |||||||||
Options to purchase approximately 19.0 million and 21.0 million shares of common stock were excluded from the denominator in the calculation of diluted net loss per share for the three months ended March 31, 2014 and 2013, respectively, as the effect would be anti-dilutive. |
Strategic_Agreements
Strategic Agreements | 3 Months Ended | ||||||||
Mar. 31, 2014 | |||||||||
Organization Consolidation And Presentation Of Financial Statements [Abstract] | ' | ||||||||
Strategic Agreements | ' | ||||||||
Note 2. Strategic Agreements | |||||||||
The collaborative research and development and other revenues associated with the Company’s major third-party collaborators are as follows (in thousands): | |||||||||
Three months ended | |||||||||
March 31, | |||||||||
2014 | 2013 | ||||||||
Collaborator | |||||||||
Impax Laboratories, Inc. (Impax) (1) | $ | 2,090 | $ | — | |||||
Zogenix, Inc. (Zogenix) (2) | 782 | 253 | |||||||
Pain Therapeutics, Inc. (Pain Therapeutics) | 451 | — | |||||||
Pfizer Inc. (Pfizer) | 14 | 13 | |||||||
Others | 175 | 647 | |||||||
Total collaborative research and development and other revenue | $ | 3,512 | $ | 913 | |||||
-1 | Amounts related to recognition of upfront fees were $2.0 million and zero for three months ended March 31, 2014 and 2013, respectively; the Company and Impax signed a license agreement effective January 3, 2014. | ||||||||
-2 | Amounts related to ratable recognition of upfront fees were $64,000 and $50,000 for three months ended March 31, 2014 and 2013, respectively; the Company and Zogenix had previously been working together under a feasibility agreement pursuant to which the Company’s research and development costs were reimbursed by Zogenix. | ||||||||
Agreement with Impax Laboratories, Inc. | |||||||||
On January 3, 2014, the Company and Impax Laboratories, Inc. (Impax) entered into a definitive agreement (the Impax Agreement). Pursuant to the Agreement, the Company has granted Impax an exclusive worldwide license to the Company’s proprietary TRANSDUR transdermal delivery technology and other intellectual property to develop and commercialize ELADUR, the Company’s investigational transdermal bupivacaine patch for the treatment of pain associated with post-herpetic neuralgia (PHN), in addition to selling certain assets and rights in and related to the product. Impax will control and fund the development and commercialization programs, and the parties will establish a joint management committee to oversee, review and coordinate the development and commercialization activities of the parties under the Impax Agreement. Impax will reimburse the Company for certain future research and development it may be requested to conduct on the product. | |||||||||
In connection with the Agreement, Impax paid a non-refundable upfront fee to the Company of $2.0 million in January 2014. The Company’s technology transfer activities were considered integral to utilizing the licensed intellectual property and, accordingly, the deliverables were accounted for as a single unit of accounting. The $2.0 million upfront fee was recognized as collaborative research and development revenue in the first quarter of 2014 when the license to the intellectual property right was delivered and the technology transfer with respect to this product candidate was completed. Impax agreed to make contingent cash payments to the Company of up to $61.0 million payable based upon the achievement of predefined milestones, of which $31.0 million are development-based milestones and $30.0 million are sales-based milestones (none of which has been achieved as of March 31, 2014). Since the milestones are expected to be achieved at a point in time when there are no performance obligations or remaining deliverables of the Company, the milestones are expected to be recognized in full upon achievement. Upon the first commercialization of ELADUR by Impax, the Company would also receive a tiered mid single-digit to low double-digit royalty on annual net product sales determined on a country-by-country basis. Impax is also required to pay to the Company a percentage of fees received in connection with any sublicense of the licensed rights. Impax may terminate the Impax Agreement without cause at any time upon prior written notice, and either party may terminate the Impax Agreement upon certain circumstances including written notice of a material uncured breach. | |||||||||
The following table provides a summary of collaborative research and development revenue recognized under the Impax Agreement (in thousands). The cumulative aggregate payments received by the Company as of March 31, 2014 were $2.1 million under the agreement. | |||||||||
Three months ended | |||||||||
March 31, | |||||||||
2014 | 2013 | ||||||||
Recognition of upfront payment | $ | 2,000 | $ | — | |||||
Research and development expenses reimbursable by Impax | 90 | — | |||||||
Total collaborative research and development revenue | $ | 2,090 | $ | — | |||||
Agreement with Pain Therapeutics, Inc. | |||||||||
In December 2002, the Company entered into an exclusive agreement with Pain Therapeutics, Inc. (Pain Therapeutics) to develop and commercialize on a worldwide basis REMOXY and other oral sustained release, abuse deterrent opioid products incorporating four specified opioid drugs, using the ORADUR technology. Total collaborative research and development revenue recognized under the agreements with Pain Therapeutics was $451,000 and zero for the three months ended March 31, 2014 and 2013, respectively. The cumulative aggregate payments received by the Company from Pain Therapeutics as of March 31, 2014 were $35.2 million under this agreement. | |||||||||
Under the terms of this agreement, Pain Therapeutics paid the Company an upfront license fee of $1.0 million, with the potential for an additional $9.3 million in performance milestone payments based on the successful development and approval of the four ORADUR-based opioids. Of these potential milestones, $9.3 million are development-based milestones (of which $1.7 million have been achieved as of March 31, 2014). There are no sales-based milestones under the agreement. | |||||||||
In March 2009, King Pharmaceuticals (King) assumed the responsibility for further development of REMOXY from Pain Therapeutics. As a result of this change, the Company continues to perform REMOXY-related activities in accordance with the terms and conditions set forth in the license agreement between the Company and Pain Therapeutics. King was substituted in lieu of Pain Therapeutics with respect to interactions with the Company in its performance of those activities including the obligation to pay the Company with respect to all REMOXY-related costs incurred by the Company. In February 2011, Pfizer acquired King and thereby assumed the rights and obligations of King with respect to REMOXY; accordingly, amounts attributed to King are now shown as Pfizer figures. | |||||||||
Total collaborative research and development revenue recognized for REMOXY-related work performed by the Company for Pfizer was $14,000 and $13,000 for the three months ended March 31, 2014 and 2013, respectively. Prior to March 2009, the Company recognized collaborative research and development revenue for REMOXY-related work under the agreements with Pain Therapeutics. The cumulative aggregate payments received by the Company from Pfizer as of March 31, 2014 were $7.1 million under this agreement. | |||||||||
Long Term Supply Agreement with King (now Pfizer) | |||||||||
In August 2009, the Company signed an exclusive long term excipient supply agreement with respect to REMOXY with King. In February 2011, Pfizer acquired King and thereby assumed the rights and obligations of King with respect to this long term supply agreement. This agreement stipulates the terms and conditions under which the Company will supply to King, based on the Company’s manufacturing cost plus a specified percentage mark-up, two key excipients used in the manufacture of REMOXY. | |||||||||
Total revenues recognized related to these excipients were zero and $273,000 in the three months ended March 31, 2014 and 2013, respectively. The associated cost of goods sold was zero and $219,000 in the three months ended March 31, 2014 and 2013, respectively. | |||||||||
Agreement with Zogenix, Inc. | |||||||||
On July 11, 2011, the Company and Zogenix, Inc., (Zogenix), entered into a Development and License Agreement (the Zogenix Agreement). The Company and Zogenix had previously been working together under a feasibility agreement pursuant to which the Company’s research and development costs were reimbursed by Zogenix. Under the Zogenix Agreement, Zogenix will be responsible for the clinical development and commercialization of a proprietary, long-acting injectable formulation of risperidone using the Company’s SABER controlled-release formulation technology in combination with Zogenix’s DosePro® needle-free, subcutaneous drug delivery system. DURECT will be responsible for non-clinical, formulation and CMC development activities. The Company will be reimbursed by Zogenix for its research and development efforts on the product. | |||||||||
Zogenix paid a non-refundable upfront fee to the Company of $2.25 million in July 2011. The Company’s research and development services are considered integral to utilizing the licensed intellectual property and, accordingly, the deliverables are accounted for as a single unit of accounting. The $2.25 million upfront fee will be recognized as collaborative research and development revenue ratably over the term of the Company’s continuing research and development involvement with Zogenix with respect to this product candidate. Zogenix is obligated to pay the Company up to $103 million in total future milestone payments with respect to the product subject to and upon the achievement of various developments, regulatory and sales milestones. Of these potential milestones, $28 million are development-based milestones (none of which has been achieved as of March 31, 2014), and $75 million are sales-based milestones (none of which has been achieved as of March 31, 2014). Zogenix is also required to pay a mid single-digit to low double-digit percentage patent royalty on annual net sales of the product determined on a jurisdiction-by-jurisdiction basis. The patent royalty term is equal to the later of the expiration of all DURECT technology patents or joint patent rights in a particular jurisdiction, the expiration of marketing exclusivity rights in such jurisdiction, or 15 years from first commercial sale in such jurisdiction. After the patent royalty term, Zogenix will continue to pay royalties on annual net sales of the product at a reduced rate for so long as Zogenix continues to sell the product in the jurisdiction. Zogenix is also required to pay to the Company a tiered percentage of fees received in connection with any sublicense of the licensed rights. | |||||||||
The Company granted to Zogenix an exclusive worldwide license, with sub-license rights, to the Company’s intellectual property rights related to the Company’s proprietary polymeric and non-polymeric controlled-release formulation technology to make and have made, use, offer for sale, sell and import risperidone products, where risperidone is the sole active agent, for administration by injection in the treatment of schizophrenia, bipolar disorder or other psychiatric related disorders in humans. The Company retains the right to supply Zogenix’s Phase III clinical trial and commercial product requirements on the terms set forth in the Zogenix Agreement. | |||||||||
The Company retains the right to terminate the Zogenix Agreement with respect to specific countries if Zogenix fails to advance the development of the product in such country, either directly or through a sublicensee. In addition, either party may terminate the Zogenix Agreement upon insolvency or bankruptcy of the other party, upon written notice of a material uncured breach or if the other party takes any act impairing such other party’s relevant intellectual property rights. Zogenix may terminate the Zogenix Agreement upon written notice if during the development or commercialization of the product, the product becomes subject to one or more serious adverse drug experiences or if either party receives notice from a regulatory authority, independent review committee, data safety monitory board or other similar body alleging significant concern regarding a patient safety issue. Zogenix may also terminate the Zogenix Agreement with or without cause, at any time upon prior written notice. | |||||||||
The following table provides a summary of collaborative research and development revenue recognized under the agreements with Zogenix (in thousands). The cumulative aggregate payments received by the Company as of March 31, 2014 were $11.0 million under these agreements. | |||||||||
Three months ended | |||||||||
March 31, | |||||||||
2014 | 2013 | ||||||||
Ratable recognition of upfront payment | $ | 64 | $ | 50 | |||||
Research and development expenses reimbursable by Zogenix | 718 | 203 | |||||||
Total collaborative research and development revenue | $ | 782 | $ | 253 | |||||
Financial_Instruments
Financial Instruments | 3 Months Ended | ||||||||||||||||
Mar. 31, 2014 | |||||||||||||||||
Fair Value Disclosures [Abstract] | ' | ||||||||||||||||
Financial Instruments | ' | ||||||||||||||||
Note 3. Financial Instruments | |||||||||||||||||
Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The Company’s valuation techniques used to measure fair value maximize the use of observable inputs and minimize the use of unobservable inputs. The Company follows a fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value. These levels of inputs are the following: | |||||||||||||||||
• | Level 1—Quoted prices in active markets for identical assets or liabilities. | ||||||||||||||||
• | Level 2—Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. | ||||||||||||||||
• | Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. | ||||||||||||||||
The Company’s financial instruments are valued using quoted prices in active markets or based upon other observable inputs. Money market funds are classified as Level 1 financial assets. Certificates of deposit, commercial paper, corporate debt securities, and U.S. Government agency securities are classified as Level 2 financial assets. The fair value of the Level 2 assets is estimated using pricing models using current observable market information for similar securities. The Company’s Level 2 investments include U.S. government-backed securities and corporate securities that are valued based upon observable inputs that may include benchmark yields, reported trades, broker/dealer quotes, issuer spreads, two-sided markets, benchmark securities, bids, offers and reference data including market research publications. The fair value of the Company’s commercial paper is based upon the time to maturity and discounted using the three-month treasury bill rate. The average remaining maturity of the Company’s Level 2 investments as of March 31, 2014 is less than twelve months and these investments are rated by S&P and Moody’s at AAA or AA- for securities and A1 or P1 for commercial paper. | |||||||||||||||||
The following is a summary of available-for-sale securities as of March 31, 2014 and December 31, 2013 (in thousands): | |||||||||||||||||
March 31, 2014 | |||||||||||||||||
Amortized | Unrealized | Unrealized | Estimated | ||||||||||||||
Cost | Gain | Loss | Fair | ||||||||||||||
Value | |||||||||||||||||
Money market funds | $ | 11 | $ | — | $ | — | $ | 11 | |||||||||
Certificates of deposit | 350 | — | — | 350 | |||||||||||||
Commercial paper | 500 | — | — | 500 | |||||||||||||
Corporate debt | 4,893 | 1 | — | 4,894 | |||||||||||||
U.S. Government agencies | 14,451 | 4 | — | 14,455 | |||||||||||||
$ | 20,205 | $ | 5 | $ | — | $ | 20,210 | ||||||||||
Reported as: | |||||||||||||||||
Cash and cash equivalents | $ | 411 | $ | — | $ | — | $ | 411 | |||||||||
Short-term investments | 15,835 | 3 | — | 15,838 | |||||||||||||
Long-term investments | 3,609 | 2 | — | 3,611 | |||||||||||||
Long-term restricted investments | 350 | — | — | 350 | |||||||||||||
$ | 20,205 | $ | 5 | $ | — | $ | 20,210 | ||||||||||
December 31, 2013 | |||||||||||||||||
Amortized | Unrealized | Unrealized | Estimated | ||||||||||||||
Cost | Gain | Loss | Fair | ||||||||||||||
Value | |||||||||||||||||
Money market funds | $ | 34 | $ | — | $ | — | $ | 34 | |||||||||
Certificates of deposit | 450 | — | — | 450 | |||||||||||||
Commercial paper | 1,249 | — | — | 1,249 | |||||||||||||
Corporate debt | 3,257 | 1 | — | 3,258 | |||||||||||||
U.S. Government agencies | 16,898 | 1 | (1 | ) | 16,898 | ||||||||||||
$ | 21,888 | $ | 2 | $ | (1 | ) | $ | 21,889 | |||||||||
Reported as: | |||||||||||||||||
Cash and cash equivalents | $ | 5,334 | $ | — | $ | — | $ | 5,334 | |||||||||
Short-term investments | 12,752 | 2 | (1 | ) | 12,753 | ||||||||||||
Long-term investments | 3,352 | — | — | 3,352 | |||||||||||||
Long-term restricted investments | 450 | — | — | 450 | |||||||||||||
$ | 21,888 | $ | 2 | $ | (1 | ) | $ | 21,889 | |||||||||
The following is a summary of the cost and estimated fair value of available-for-sale securities at March 31, 2014, by contractual maturity (in thousands): | |||||||||||||||||
March 31, 2014 | |||||||||||||||||
Amortized | Estimated | ||||||||||||||||
Cost | Fair | ||||||||||||||||
Value | |||||||||||||||||
Mature in one year or less | $ | 16,585 | $ | 16,588 | |||||||||||||
Mature after one year through five years | 3,609 | 3,611 | |||||||||||||||
$ | 20,194 | $ | 20,199 | ||||||||||||||
There were no securities that have had an unrealized loss for more than 12 months as of March 31, 2014. | |||||||||||||||||
As of December 31, 2013, unrealized losses on available-for-sale investments are not attributed to credit risk and are considered to be temporary. The Company believes that it is more-likely-than-not that investments in an unrealized loss position will be held until maturity or the recovery of the cost basis of the investment. To date, the Company has not recorded any impairment charges on marketable securities related to other-than-temporary declines in market value. |
StockBased_Compensation
Stock-Based Compensation | 3 Months Ended | ||||||||||||||||
Mar. 31, 2014 | |||||||||||||||||
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ' | ||||||||||||||||
Stock-Based Compensation | ' | ||||||||||||||||
Note 4. Stock-Based Compensation | |||||||||||||||||
As of March 31, 2014, the Company has three stock-based compensation plans. The stock-based compensation cost that has been included in the statements of comprehensive loss is shown as below (in thousands): | |||||||||||||||||
Three months ended | |||||||||||||||||
March 31, | |||||||||||||||||
2014 | 2013 | ||||||||||||||||
Cost of product revenues | $ | 37 | $ | 49 | |||||||||||||
Research and development | 415 | 570 | |||||||||||||||
Selling, general and administrative | 274 | 326 | |||||||||||||||
Total stock-based compensation | $ | 726 | $ | 945 | |||||||||||||
As of March 31, 2014 and December 31, 2013, $13,000 of stock-based compensation cost was capitalized in inventory on the Company’s balance sheets. | |||||||||||||||||
The Company uses the Black-Scholes option pricing model to value its stock options. The expected life computation is based on historical exercise patterns and post-vesting termination behavior. The Company considered its historical volatility in developing its estimate of expected volatility. | |||||||||||||||||
The Company used the following assumptions to estimate the fair value of stock options granted (including fully vested options issued in January 2014 and February 2013) and shares purchased under its employee stock purchase plan for the three months ended March 31, 2014 and 2013: | |||||||||||||||||
Stock Options | Employee Stock | ||||||||||||||||
Purchase Plan | |||||||||||||||||
Three months ended | Three months ended | ||||||||||||||||
March 31, | March 31, | ||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
Risk-free rate | 2.0-2.8 | % | 0.8-1.5 | % | 0.1 | % | 0.2 | % | |||||||||
Expected dividend yield | — | — | — | — | |||||||||||||
Expected life of option (in years) | 6.5-9.3 | 5.3-7.8 | 0.5 | 1.3 | |||||||||||||
Volatility | 77-84 | % | 77-86 | % | 81 | % | 69 | % | |||||||||
Forfeiture rate | 7.2 | % | 8.4 | % | — | — |
Summary_of_Significant_Account1
Summary of Significant Accounting Policies (Policies) | 3 Months Ended | ||||||||
Mar. 31, 2014 | |||||||||
Accounting Policies [Abstract] | ' | ||||||||
Nature of Operations | ' | ||||||||
Nature of Operations | |||||||||
DURECT Corporation (the Company) was incorporated in the state of Delaware on February 6, 1998. The Company is a pharmaceutical company developing therapies based on its proprietary drug formulations and delivery platform technologies. The Company has several products under development by itself and with third party collaborators. The Company also manufactures and sells osmotic pumps used in laboratory research, and designs, develops and manufactures a wide range of standard and custom biodegradable polymers and excipients for pharmaceutical and medical device clients for use as raw materials in their products. In addition, the Company conducts research and development of pharmaceutical products in collaboration with third party pharmaceutical and biotechnology companies. | |||||||||
Basis of Presentation | ' | ||||||||
Basis of Presentation | |||||||||
The accompanying unaudited financial statements include the accounts of the Company. These financial statements have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission (SEC), and therefore do not include all the information and footnotes necessary for a complete presentation of the Company’s results of operations, financial position and cash flows in conformity with U.S. generally accepted accounting principles (U.S. GAAP). The unaudited financial statements reflect all adjustments (consisting only of normal recurring adjustments) which are, in the opinion of management, necessary for a fair presentation of the financial position at March 31, 2014, the operating results and comprehensive loss for the three months ended March 31, 2014 and 2013, and cash flows for the three months ended March 31, 2014 and 2013. The balance sheet as of December 31, 2013 has been derived from audited financial statements at that date but does not include all of the information and footnotes required by U.S. GAAP for complete financial statements. These financial statements and notes should be read in conjunction with the Company’s audited financial statements and notes thereto, included in the Company’s annual report on Form 10-K for the fiscal year ended December 31, 2013 filed with the SEC. | |||||||||
The results of operations for the interim periods presented are not necessarily indicative of results that may be expected for any other interim period or for the full fiscal year. | |||||||||
Inventories | ' | ||||||||
Inventories | |||||||||
Inventories are stated at the lower of cost or market, with cost determined on a first-in, first-out basis. The Company’s inventories consisted of the following (in thousands): | |||||||||
March 31, | December 31, | ||||||||
2014 | 2013 | ||||||||
(unaudited) | |||||||||
Raw materials | $ | 1,348 | $ | 1,404 | |||||
Work in process | 1,371 | 1,063 | |||||||
Finished goods | 791 | 1,035 | |||||||
Total inventories | $ | 3,510 | $ | 3,502 | |||||
Revenue Recognition | ' | ||||||||
Revenue Recognition | |||||||||
Revenue from the sale of products is recognized when there is persuasive evidence that an arrangement exists, the product is shipped and title transfers to customers, provided no continuing obligation on the Company’s part exists, the price is fixed or determinable and the collectability of the amounts owed is reasonably assured. The Company enters into license and collaboration agreements under which it may receive upfront license fees, research funding and contingent milestone payments and royalties. The Company’s deliverables under these arrangements typically consist of granting licenses to intellectual property rights and providing research and development services. The accounting standards contain a presumption that separate contracts entered into at or near the same time with the same entity or related parties were negotiated as a package and should be evaluated as a single agreement. | |||||||||
Revenue on cost-plus-fee contracts, such as under contracts to perform research and development for others, is recognized as the related services are rendered as determined by the extent of reimbursable costs incurred plus estimated fees thereon. | |||||||||
Comprehensive Income (Loss) | ' | ||||||||
Comprehensive Income (Loss) | |||||||||
Components of other comprehensive income (loss) are comprised entirely of unrealized gains and losses on the Company’s available-for-sale securities for all periods presented and are included in total comprehensive income (loss) as follows (in thousands). | |||||||||
Three months ended | |||||||||
March 31, | |||||||||
2014 | 2013 | ||||||||
Net loss | $ | (3,600 | ) | $ | (5,183 | ) | |||
Net change in unrealized gain on available-for-sale investments, net of tax | 4 | 2 | |||||||
Comprehensive loss | $ | (3,596 | ) | $ | (5,181 | ) | |||
The tax effect of the changes in accumulated other comprehensive income (loss) was immaterial for the periods presented. Accumulated other comprehensive income as of March 31, 2014 and December 31, 2013 is entirely comprised of net unrealized gains on available-for-sale securities. | |||||||||
Net Income (Loss) Per Share | ' | ||||||||
Net Income (Loss) Per Share | |||||||||
Basic net income (loss) per share is calculated by dividing the net income (loss) by the weighted-average number of common shares outstanding. Diluted net income (loss) per share is computed using the weighted-average number of common shares outstanding and common stock equivalents (i.e., options to purchase common stock) outstanding during the period, if dilutive, using the treasury stock method for options and warrants. | |||||||||
Options to purchase approximately 19.0 million and 21.0 million shares of common stock were excluded from the denominator in the calculation of diluted net loss per share for the three months ended March 31, 2014 and 2013, respectively, as the effect would be anti-dilutive. |
Summary_of_Significant_Account2
Summary of Significant Accounting Policies (Tables) | 3 Months Ended | ||||||||
Mar. 31, 2014 | |||||||||
Accounting Policies [Abstract] | ' | ||||||||
Summary of Components of Inventories | ' | ||||||||
The Company’s inventories consisted of the following (in thousands): | |||||||||
March 31, | December 31, | ||||||||
2014 | 2013 | ||||||||
(unaudited) | |||||||||
Raw materials | $ | 1,348 | $ | 1,404 | |||||
Work in process | 1,371 | 1,063 | |||||||
Finished goods | 791 | 1,035 | |||||||
Total inventories | $ | 3,510 | $ | 3,502 | |||||
Summary of Components of Comprehensive Income (Loss) | ' | ||||||||
Components of other comprehensive income (loss) are comprised entirely of unrealized gains and losses on the Company’s available-for-sale securities for all periods presented and are included in total comprehensive income (loss) as follows (in thousands). | |||||||||
Three months ended | |||||||||
March 31, | |||||||||
2014 | 2013 | ||||||||
Net loss | $ | (3,600 | ) | $ | (5,183 | ) | |||
Net change in unrealized gain on available-for-sale investments, net of tax | 4 | 2 | |||||||
Comprehensive loss | $ | (3,596 | ) | $ | (5,181 | ) | |||
Strategic_Agreements_Tables
Strategic Agreements (Tables) | 3 Months Ended | ||||||||
Mar. 31, 2014 | |||||||||
Summary of Collaborative Research and Development and Other Revenues Associated with Company's Major Third-Party Collaborators | ' | ||||||||
The collaborative research and development and other revenues associated with the Company’s major third-party collaborators are as follows (in thousands): | |||||||||
Three months ended | |||||||||
March 31, | |||||||||
2014 | 2013 | ||||||||
Collaborator | |||||||||
Impax Laboratories, Inc. (Impax) (1) | $ | 2,090 | $ | — | |||||
Zogenix, Inc. (Zogenix) (2) | 782 | 253 | |||||||
Pain Therapeutics, Inc. (Pain Therapeutics) | 451 | — | |||||||
Pfizer Inc. (Pfizer) | 14 | 13 | |||||||
Others | 175 | 647 | |||||||
Total collaborative research and development and other revenue | $ | 3,512 | $ | 913 | |||||
-1 | Amounts related to recognition of upfront fees were $2.0 million and zero for three months ended March 31, 2014 and 2013, respectively; the Company and Impax signed a license agreement effective January 3, 2014. | ||||||||
-2 | Amounts related to ratable recognition of upfront fees were $64,000 and $50,000 for three months ended March 31, 2014 and 2013, respectively; the Company and Zogenix had previously been working together under a feasibility agreement pursuant to which the Company’s research and development costs were reimbursed by Zogenix. | ||||||||
Agreement with Impax Laboratories, Inc. [Member] | ' | ||||||||
Summary of Collaborative Research and Development Revenue Recognized | ' | ||||||||
The following table provides a summary of collaborative research and development revenue recognized under the Impax Agreement (in thousands). The cumulative aggregate payments received by the Company as of March 31, 2014 were $2.1 million under the agreement. | |||||||||
Three months ended | |||||||||
March 31, | |||||||||
2014 | 2013 | ||||||||
Recognition of upfront payment | $ | 2,000 | $ | — | |||||
Research and development expenses reimbursable by Impax | 90 | — | |||||||
Total collaborative research and development revenue | $ | 2,090 | $ | — | |||||
Agreement with Zogenix, Inc. [Member] | ' | ||||||||
Summary of Collaborative Research and Development Revenue Recognized | ' | ||||||||
The following table provides a summary of collaborative research and development revenue recognized under the agreements with Zogenix (in thousands). The cumulative aggregate payments received by the Company as of March 31, 2014 were $11.0 million under these agreements. | |||||||||
Three months ended | |||||||||
March 31, | |||||||||
2014 | 2013 | ||||||||
Ratable recognition of upfront payment | $ | 64 | $ | 50 | |||||
Research and development expenses reimbursable by Zogenix | 718 | 203 | |||||||
Total collaborative research and development revenue | $ | 782 | $ | 253 | |||||
Financial_Instruments_Tables
Financial Instruments (Tables) | 3 Months Ended | ||||||||||||||||
Mar. 31, 2014 | |||||||||||||||||
Fair Value Disclosures [Abstract] | ' | ||||||||||||||||
Summary of Available-for-Sale Securities | ' | ||||||||||||||||
The following is a summary of available-for-sale securities as of March 31, 2014 and December 31, 2013 (in thousands): | |||||||||||||||||
March 31, 2014 | |||||||||||||||||
Amortized | Unrealized | Unrealized | Estimated | ||||||||||||||
Cost | Gain | Loss | Fair | ||||||||||||||
Value | |||||||||||||||||
Money market funds | $ | 11 | $ | — | $ | — | $ | 11 | |||||||||
Certificates of deposit | 350 | — | — | 350 | |||||||||||||
Commercial paper | 500 | — | — | 500 | |||||||||||||
Corporate debt | 4,893 | 1 | — | 4,894 | |||||||||||||
U.S. Government agencies | 14,451 | 4 | — | 14,455 | |||||||||||||
$ | 20,205 | $ | 5 | $ | — | $ | 20,210 | ||||||||||
Reported as: | |||||||||||||||||
Cash and cash equivalents | $ | 411 | $ | — | $ | — | $ | 411 | |||||||||
Short-term investments | 15,835 | 3 | — | 15,838 | |||||||||||||
Long-term investments | 3,609 | 2 | — | 3,611 | |||||||||||||
Long-term restricted investments | 350 | — | — | 350 | |||||||||||||
$ | 20,205 | $ | 5 | $ | — | $ | 20,210 | ||||||||||
December 31, 2013 | |||||||||||||||||
Amortized | Unrealized | Unrealized | Estimated | ||||||||||||||
Cost | Gain | Loss | Fair | ||||||||||||||
Value | |||||||||||||||||
Money market funds | $ | 34 | $ | — | $ | — | $ | 34 | |||||||||
Certificates of deposit | 450 | — | — | 450 | |||||||||||||
Commercial paper | 1,249 | — | — | 1,249 | |||||||||||||
Corporate debt | 3,257 | 1 | — | 3,258 | |||||||||||||
U.S. Government agencies | 16,898 | 1 | (1 | ) | 16,898 | ||||||||||||
$ | 21,888 | $ | 2 | $ | (1 | ) | $ | 21,889 | |||||||||
Reported as: | |||||||||||||||||
Cash and cash equivalents | $ | 5,334 | $ | — | $ | — | $ | 5,334 | |||||||||
Short-term investments | 12,752 | 2 | (1 | ) | 12,753 | ||||||||||||
Long-term investments | 3,352 | — | — | 3,352 | |||||||||||||
Long-term restricted investments | 450 | — | — | 450 | |||||||||||||
$ | 21,888 | $ | 2 | $ | (1 | ) | $ | 21,889 | |||||||||
Summary of Cost and Estimated Fair Value of Available-for-Sale Securities at by Contractual Maturity | ' | ||||||||||||||||
The following is a summary of the cost and estimated fair value of available-for-sale securities at March 31, 2014, by contractual maturity (in thousands): | |||||||||||||||||
March 31, 2014 | |||||||||||||||||
Amortized | Estimated | ||||||||||||||||
Cost | Fair | ||||||||||||||||
Value | |||||||||||||||||
Mature in one year or less | $ | 16,585 | $ | 16,588 | |||||||||||||
Mature after one year through five years | 3,609 | 3,611 | |||||||||||||||
$ | 20,194 | $ | 20,199 | ||||||||||||||
StockBased_Compensation_Tables
Stock-Based Compensation (Tables) | 3 Months Ended | ||||||||||||||||
Mar. 31, 2014 | |||||||||||||||||
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ' | ||||||||||||||||
Summary of Stock-Based Compensation Cost that has been Included in the Statements of Comprehensive Loss | ' | ||||||||||||||||
As of March 31, 2014, the Company has three stock-based compensation plans. The stock-based compensation cost that has been included in the statements of comprehensive loss is shown as below (in thousands): | |||||||||||||||||
Three months ended | |||||||||||||||||
March 31, | |||||||||||||||||
2014 | 2013 | ||||||||||||||||
Cost of product revenues | $ | 37 | $ | 49 | |||||||||||||
Research and development | 415 | 570 | |||||||||||||||
Selling, general and administrative | 274 | 326 | |||||||||||||||
Total stock-based compensation | $ | 726 | $ | 945 | |||||||||||||
Summary of Assumptions Used to Estimate Fair Value of Options Granted and Shares Purchased | ' | ||||||||||||||||
The Company used the following assumptions to estimate the fair value of stock options granted (including fully vested options issued in January 2014 and February 2013) and shares purchased under its employee stock purchase plan for the three months ended March 31, 2014 and 2013: | |||||||||||||||||
Stock Options | Employee Stock | ||||||||||||||||
Purchase Plan | |||||||||||||||||
Three months ended | Three months ended | ||||||||||||||||
March 31, | March 31, | ||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
Risk-free rate | 2.0-2.8 | % | 0.8-1.5 | % | 0.1 | % | 0.2 | % | |||||||||
Expected dividend yield | — | — | — | — | |||||||||||||
Expected life of option (in years) | 6.5-9.3 | 5.3-7.8 | 0.5 | 1.3 | |||||||||||||
Volatility | 77-84 | % | 77-86 | % | 81 | % | 69 | % | |||||||||
Forfeiture rate | 7.2 | % | 8.4 | % | — | — |
Summary_of_Significant_Account3
Summary of Significant Accounting Policies - Additional Information (Detail) | 3 Months Ended | |
In Millions, unless otherwise specified | Mar. 31, 2014 | Mar. 31, 2013 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ' | ' |
State of incorporation | 'Delaware | ' |
Date of incorporation | 6-Feb-98 | ' |
Stock Options [Member] | ' | ' |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ' | ' |
Options to purchase common stock excluded from the denominator in the calculation of diluted net income(loss) per share | 19 | 21 |
Summary_of_Significant_Account4
Summary of Significant Accounting Policies - Summary of Components of Inventories (Detail) (USD $) | Mar. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Inventory Net [Abstract] | ' | ' |
Raw materials | $1,348 | $1,404 |
Work in process | 1,371 | 1,063 |
Finished goods | 791 | 1,035 |
Total inventories | $3,510 | $3,502 |
Summary_of_Significant_Account5
Summary of Significant Accounting Policies - Summary of Components of Comprehensive Income (loss) (Detail) (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2014 | Mar. 31, 2013 |
Comprehensive Income Net Of Tax [Abstract] | ' | ' |
Net loss | ($3,600) | ($5,183) |
Net change in unrealized gain on available-for-sale investments, net of tax | 4 | 2 |
Comprehensive loss | ($3,596) | ($5,181) |
Strategic_Agreements_Summary_o
Strategic Agreements - Summary of Collaborative Research and Development and Other Revenues Associated with Company's Major Third-Party Collaborators (Detail) (USD $) | 3 Months Ended | |
Mar. 31, 2014 | Mar. 31, 2013 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ' | ' |
Total collaborative research and development and other revenue | $3,512,000 | $913,000 |
Zogenix, Inc. [Member] | ' | ' |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ' | ' |
Total collaborative research and development and other revenue | 782,000 | 253,000 |
Impax Laboratories, Inc. [Member] | ' | ' |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ' | ' |
Total collaborative research and development and other revenue | 2,090,000 | ' |
Pain Therapeutics, Inc. [Member] | ' | ' |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ' | ' |
Total collaborative research and development and other revenue | 451,000 | ' |
Pfizer Inc. [Member] | ' | ' |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ' | ' |
Total collaborative research and development and other revenue | 14,000 | 13,000 |
Others [Member] | ' | ' |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ' | ' |
Total collaborative research and development and other revenue | $175,000 | $647,000 |
Strategic_Agreements_Summary_o1
Strategic Agreements - Summary of Collaborative Research and Development and Other Revenues Associated with Company's Major Third-Party Collaborators (Parenthetical) (Detail) (USD $) | 3 Months Ended | |
Mar. 31, 2014 | Mar. 31, 2013 | |
Zogenix, Inc. [Member] | ' | ' |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ' | ' |
Amounts related to the ratable recognition of upfront fees | $64,000 | $50,000 |
Impax Laboratories, Inc. [Member] | ' | ' |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ' | ' |
Amounts related to the ratable recognition of upfront fees | $2,000,000 | $0 |
Strategic_Agreements_Agreement
Strategic Agreements - Agreement with Impax Laboratories, Inc. - Additional Information (Detail) (USD $) | 0 Months Ended | 3 Months Ended | |
Jan. 03, 2014 | Mar. 31, 2014 | Mar. 31, 2013 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ' | ' | ' |
Total collaborative research and development and other revenue | ' | $3,512,000 | $913,000 |
Agreement with Impax Laboratories, Inc. [Member] | ' | ' | ' |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ' | ' | ' |
Non-refundable upfront fee | 2,000,000 | ' | ' |
Total collaborative research and development and other revenue | ' | 2,090,000 | ' |
Future milestone payments | 61,000,000 | ' | ' |
Cumulative aggregate payments received by the Company | ' | 2,100,000 | ' |
Agreement with Impax Laboratories, Inc. [Member] | Development-Based Milestones [Member] | ' | ' | ' |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ' | ' | ' |
Future milestone payments | 31,000,000 | ' | ' |
Agreement with Impax Laboratories, Inc. [Member] | Sales-Based Milestones [Member] | ' | ' | ' |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ' | ' | ' |
Future milestone payments | 30,000,000 | ' | ' |
Revenue recognition milestone achieved | ' | ' | ' |
Strategic_Agreements_Summary_o2
Strategic Agreements - Summary of Collaborative Research and Development Revenue Recognized (Detail) (USD $) | 3 Months Ended | |
Mar. 31, 2014 | Mar. 31, 2013 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ' | ' |
Total collaborative research and development and other revenue | $3,512,000 | $913,000 |
Agreement with Zogenix, Inc. [Member] | ' | ' |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ' | ' |
Ratable recognition of upfront payment | 64,000 | 50,000 |
Research and development expenses reimbursable by Impax | 718,000 | 203,000 |
Total collaborative research and development and other revenue | 782,000 | 253,000 |
Agreement with Impax Laboratories, Inc. [Member] | ' | ' |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ' | ' |
Ratable recognition of upfront payment | 2,000,000 | ' |
Research and development expenses reimbursable by Impax | 90,000 | ' |
Total collaborative research and development and other revenue | $2,090,000 | ' |
Strategic_Agreements_Agreement1
Strategic Agreements - Agreement with Pain Therapeutics, Inc. - Additional Information (Detail) (USD $) | 1 Months Ended | 3 Months Ended | 136 Months Ended | |
Dec. 31, 2002 | Mar. 31, 2014 | Mar. 31, 2013 | Mar. 31, 2014 | |
Drug | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ' | ' | ' | ' |
Total collaborative research and development and other revenue | ' | $3,512,000 | $913,000 | ' |
Agreement with Pain Therapeutics, Inc. [Member] | ' | ' | ' | ' |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ' | ' | ' | ' |
Number of specified opioid drugs | 4 | ' | ' | ' |
Total collaborative research and development and other revenue | ' | 451,000 | 0 | ' |
Cumulative aggregate payments received by the Company | ' | ' | ' | 35,200,000 |
Upfront license fee | ' | 1,000,000 | ' | ' |
Performance milestone payments based on successful development | ' | 9,300,000 | ' | 9,300,000 |
Agreement with Pfizer [Member] | ' | ' | ' | ' |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ' | ' | ' | ' |
Total collaborative research and development and other revenue | ' | 14,000 | 13,000 | ' |
Cumulative aggregate payments received by the Company | ' | ' | ' | 7,100,000 |
Development-Based Milestones [Member] | Agreement with Pain Therapeutics, Inc. [Member] | ' | ' | ' | ' |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ' | ' | ' | ' |
Performance milestone payments based on successful development | ' | 9,300,000 | ' | 9,300,000 |
Revenue recognition milestone achieved | ' | 1,700,000 | ' | ' |
Sales-Based Milestones [Member] | Agreement with Pain Therapeutics, Inc. [Member] | ' | ' | ' | ' |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ' | ' | ' | ' |
Performance milestone payments based on successful development | ' | ' | ' | ' |
Strategic_Agreements_Long_Term
Strategic Agreements - Long Term Supply Agreement with King - Additional Information (Detail) (USD $) | 3 Months Ended | |
Mar. 31, 2014 | Mar. 31, 2013 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ' | ' |
Product revenue, net | $2,781,000 | $3,240,000 |
Cost of goods sold | 1,063,000 | 1,658,000 |
Agreement with Pfizer [Member] | ' | ' |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ' | ' |
Product revenue, net | 0 | 273,000 |
Cost of goods sold | $0 | $219,000 |
Strategic_Agreements_Agreement2
Strategic Agreements - Agreement with Zogenix, Inc. - Additional Information (Detail) (Agreement with Zogenix, Inc. [Member], USD $) | 3 Months Ended | 32 Months Ended | |||
In Millions, unless otherwise specified | Mar. 31, 2014 | Mar. 31, 2014 | Mar. 31, 2014 | Mar. 31, 2014 | Jul. 31, 2011 |
Development-Based Milestones [Member] | Sales-Based Milestones [Member] | Up-front Payment Arrangement [Member] | Up-front Payment Arrangement [Member] | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ' | ' | ' | ' | ' |
Non-refundable upfront fee | ' | ' | ' | $2.25 | $2.25 |
Future milestone payments | 103 | 28 | 75 | ' | ' |
Revenue recognition milestone achieved | ' | 0 | 0 | ' | ' |
Patent royalty term | '15 years | ' | ' | ' | ' |
Cumulative aggregate payments received by the Company | $11 | ' | ' | ' | ' |
Financial_Instruments_Summary_
Financial Instruments - Summary of Available-for-Sale Securities (Detail) (USD $) | Mar. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Schedule of Available-for-sale Securities [Line Items] | ' | ' |
Amortized Cost | $20,205 | $21,888 |
Unrealized Gain | 5 | 2 |
Unrealized Loss | ' | -1 |
Estimated Fair Value | 20,210 | 21,889 |
Money market funds [Member] | ' | ' |
Schedule of Available-for-sale Securities [Line Items] | ' | ' |
Amortized Cost | 11 | 34 |
Unrealized Gain | ' | ' |
Unrealized Loss | ' | ' |
Estimated Fair Value | 11 | 34 |
Certificates of deposit [Member] | ' | ' |
Schedule of Available-for-sale Securities [Line Items] | ' | ' |
Amortized Cost | 350 | 450 |
Unrealized Gain | ' | ' |
Unrealized Loss | ' | ' |
Estimated Fair Value | 350 | 450 |
Commercial paper [Member] | ' | ' |
Schedule of Available-for-sale Securities [Line Items] | ' | ' |
Amortized Cost | 500 | 1,249 |
Unrealized Gain | ' | ' |
Unrealized Loss | ' | ' |
Estimated Fair Value | 500 | 1,249 |
Corporate debt [Member] | ' | ' |
Schedule of Available-for-sale Securities [Line Items] | ' | ' |
Amortized Cost | 4,893 | 3,257 |
Unrealized Gain | 1 | 1 |
Unrealized Loss | ' | ' |
Estimated Fair Value | 4,894 | 3,258 |
U.S. Government agencies [Member] | ' | ' |
Schedule of Available-for-sale Securities [Line Items] | ' | ' |
Amortized Cost | 14,451 | 16,898 |
Unrealized Gain | 4 | 1 |
Unrealized Loss | ' | -1 |
Estimated Fair Value | 14,455 | 16,898 |
Cash and cash equivalents [Member] | ' | ' |
Schedule of Available-for-sale Securities [Line Items] | ' | ' |
Amortized Cost | 411 | 5,334 |
Unrealized Gain | ' | ' |
Unrealized Loss | ' | ' |
Estimated Fair Value | 411 | 5,334 |
Short-term investments [Member] | ' | ' |
Schedule of Available-for-sale Securities [Line Items] | ' | ' |
Amortized Cost | 15,835 | 12,752 |
Unrealized Gain | 3 | 2 |
Unrealized Loss | ' | -1 |
Estimated Fair Value | 15,838 | 12,753 |
Long-term investments [Member] | ' | ' |
Schedule of Available-for-sale Securities [Line Items] | ' | ' |
Amortized Cost | 3,609 | 3,352 |
Unrealized Gain | 2 | ' |
Unrealized Loss | ' | ' |
Estimated Fair Value | 3,611 | 3,352 |
Long-term restricted investments [Member] | ' | ' |
Schedule of Available-for-sale Securities [Line Items] | ' | ' |
Amortized Cost | 350 | 450 |
Unrealized Gain | ' | ' |
Unrealized Loss | ' | ' |
Estimated Fair Value | $350 | $450 |
Financial_Instruments_Summary_1
Financial Instruments - Summary of Cost and Estimated Fair Value of Available-for-Sale Securities at by Contractual Maturity (Detail) (USD $) | Mar. 31, 2014 |
In Thousands, unless otherwise specified | |
Investments Debt And Equity Securities [Abstract] | ' |
Mature in one year or less, Amortized Cost | $16,585 |
Mature after one year through five years, Amortized Cost | 3,609 |
Amortized Cost | 20,194 |
Mature in one year or less, Estimated Fair Value | 16,588 |
Mature after one year through five years, Estimated Fair Value | 3,611 |
Estimated Fair Value | $20,199 |
Financial_Instruments_Addition
Financial Instruments - Additional Information (Detail) (USD $) | Mar. 31, 2014 |
Investments Debt And Equity Securities [Abstract] | ' |
Unrealized loss of securities | ' |
StockBased_Compensation_Additi
Stock-Based Compensation - Additional Information (Detail) (USD $) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2014 | Dec. 31, 2013 | |
Plans | ||
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ' | ' |
Number of stock-based compensation plans | 3 | ' |
Stock-based compensation cost capitalized in inventory | $13,000 | $13,000 |
StockBased_Compensation_Summar
Stock-Based Compensation - Summary of Stock-Based Compensation Cost that has been Included in the Statements of Comprehensive Loss (Detail) (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2014 | Mar. 31, 2013 |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' |
Total stock-based compensation | $726 | $945 |
Cost of product revenues [Member] | ' | ' |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' |
Total stock-based compensation | 37 | 49 |
Research and development [Member] | ' | ' |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' |
Total stock-based compensation | 415 | 570 |
Selling, general and administrative [Member] | ' | ' |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' |
Total stock-based compensation | $274 | $326 |
StockBased_Compensation_Summar1
Stock-Based Compensation - Summary of Assumptions Used to Estimate Fair Value of Options Granted and Shares Purchased (Detail) | 3 Months Ended | |
Mar. 31, 2014 | Mar. 31, 2013 | |
Employee Stock Purchase Plan [Member] | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' |
Risk-free rate | 0.10% | 0.20% |
Expected dividend yield | ' | ' |
Expected life of option (in years) | '6 months | '1 year 3 months 18 days |
Volatility | 81.00% | 69.00% |
Forfeiture rate | ' | ' |
Stock Option Plan [Member] | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' |
Risk-free rate, minimum | 2.00% | 0.80% |
Risk-free rate, maximum | 2.80% | 1.50% |
Expected dividend yield | ' | ' |
Volatility, minimum | 77.00% | 77.00% |
Volatility, maximum | 84.00% | 86.00% |
Forfeiture rate | 7.20% | 8.40% |
Stock Option Plan [Member] | Minimum [Member] | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' |
Expected life of option (in years) | '6 years 6 months | '5 years 3 months 18 days |
Stock Option Plan [Member] | Maximum [Member] | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' |
Expected life of option (in years) | '9 years 3 months 18 days | '7 years 9 months 18 days |