Document_and_Entity_Informatio
Document and Entity Information | 6 Months Ended | |
Jun. 30, 2014 | Jul. 23, 2014 | |
Document Information [Line Items] | ' | ' |
Document Type | '10-Q | ' |
Amendment Flag | 'false | ' |
Document Period End Date | 30-Jun-14 | ' |
Document Fiscal Year Focus | '2014 | ' |
Document Fiscal Period Focus | 'Q2 | ' |
Trading Symbol | 'IDIX | ' |
Entity Registrant Name | 'IDENIX PHARMACEUTICALS INC | ' |
Entity Central Index Key | '0001093649 | ' |
Current Fiscal Year End Date | '--12-31 | ' |
Entity Filer Category | 'Accelerated Filer | ' |
Entity Common Stock, Shares Outstanding | ' | 151,503,782 |
Condensed_Consolidated_Balance
Condensed Consolidated Balance Sheets (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Current assets: | ' | ' |
Cash and cash equivalents | $177,613 | $122,006 |
Restricted cash | 1,402 | 1,402 |
Receivables from related party | 1,050 | 1,409 |
Other current assets | 6,222 | 4,935 |
Total current assets | 186,287 | 129,752 |
Property and equipment, net | 2,599 | 2,782 |
Receivables from related party, net of current portion | 4,555 | 5,082 |
Other assets | 4,185 | 3,395 |
Total assets | 197,626 | 141,011 |
Current liabilities: | ' | ' |
Accounts payable | 7,428 | 7,781 |
Accrued expenses | 19,666 | 9,303 |
Deferred revenue, related party | 714 | 714 |
Other current liabilities | 449 | 392 |
Total current liabilities | 28,257 | 18,190 |
Other long-term liabilities | 9,240 | 9,278 |
Deferred revenue | 4,272 | 4,272 |
Deferred revenue, related party, net of current portion | 2,917 | 3,274 |
Total liabilities | 44,686 | 35,014 |
Commitments and contingencies (Note 7) | ' | ' |
Stockholders' equity: | ' | ' |
Common stock, $0.001 par value; 200,000,000 shares authorized at June 30, 2014 and December 31, 2013; 151,470,155 and 134,119,350 shares issued and outstanding at June 30, 2014 and December 31, 2013, respectively | 151 | 134 |
Additional paid-in capital | 1,080,984 | 935,406 |
Accumulated other comprehensive income | 783 | 859 |
Accumulated deficit | -928,978 | -830,402 |
Total stockholders' equity | 152,940 | 105,997 |
Total liabilities and stockholders' equity | $197,626 | $141,011 |
Condensed_Consolidated_Balance1
Condensed Consolidated Balance Sheets (Parenthetical) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
Common stock, par value | $0.00 | $0.00 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 151,470,155 | 134,119,350 |
Common stock, shares outstanding | 151,470,155 | 134,119,350 |
Condensed_Consolidated_Stateme
Condensed Consolidated Statements of Operations and Comprehensive Loss (USD $) | 3 Months Ended | 6 Months Ended | ||
In Thousands, except Per Share data, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 |
Revenues: | ' | ' | ' | ' |
Collaboration revenue - related party | ($26,071) | $112 | ($29,078) | $964 |
Total revenues | -26,071 | 112 | -29,078 | 964 |
Operating expenses: | ' | ' | ' | ' |
Cost of revenues | ' | 368 | ' | 700 |
Research and development | 24,185 | 19,779 | 45,262 | 43,787 |
General and administrative | 14,492 | 9,141 | 24,795 | 16,676 |
Total operating expenses | 38,677 | 29,288 | 70,057 | 61,163 |
Loss from operations | -64,748 | -29,176 | -99,135 | -60,199 |
Other income, net | 286 | 257 | 560 | 528 |
Loss before income taxes | ' | ' | -98,575 | -59,671 |
Income tax expense | ' | ' | -1 | -1 |
Net loss | -64,462 | -28,919 | -98,576 | -59,672 |
Basic and diluted net loss per common share | ($0.43) | ($0.22) | ($0.67) | ($0.45) |
Shares used in computing basic and diluted net loss per common share | 150,968 | 133,960 | 148,059 | 133,959 |
Comprehensive loss: | ' | ' | ' | ' |
Net loss | -64,462 | -28,919 | -98,576 | -59,672 |
Changes in other comprehensive income: | ' | ' | ' | ' |
Foreign currency translation adjustment | -125 | 151 | -76 | -198 |
Comprehensive loss | ($64,587) | ($28,768) | ($98,652) | ($59,870) |
Condensed_Consolidated_Stateme1
Condensed Consolidated Statements of Cash Flows (USD $) | 6 Months Ended | |
In Thousands, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 |
Cash flows from operating activities: | ' | ' |
Net loss | ($98,576) | ($59,672) |
Adjustments to reconcile net loss to net cash used in operating activities: | ' | ' |
Depreciation | 538 | 1,144 |
Share-based compensation expense | 3,082 | 2,635 |
Revenue adjustment for contingently issuable shares | 29,449 | -607 |
Other | 5 | 14 |
Changes in operating assets and liabilities: | ' | ' |
Receivables from related party | 359 | 751 |
Other assets | -759 | -989 |
Accounts payable | -353 | 1,297 |
Accrued expenses and other current liabilities | 9,564 | 2,923 |
Deferred revenue, related party | -357 | -357 |
Other liabilities | -34 | -55 |
Net cash used in operating activities | -57,082 | -52,916 |
Cash flows from investing activities: | ' | ' |
Purchases of property and equipment | -336 | -881 |
Release of restricted cash | ' | 701 |
Net cash used in investing activities | -336 | -180 |
Cash flows from financing activities: | ' | ' |
Proceeds from exercise of common stock options | 6,474 | 15 |
Proceeds from issuance of common stock, net of offering costs | 106,590 | ' |
Net cash provided by financing activities | 113,064 | 15 |
Effect of changes in exchange rates on cash and cash equivalents | -39 | -145 |
Net increase (decrease) in cash and cash equivalents | 55,607 | -53,226 |
Cash and cash equivalents at beginning of period | 122,006 | 230,826 |
Cash and cash equivalents at end of period | $177,613 | $177,600 |
BUSINESS_OVERVIEW
BUSINESS OVERVIEW | 6 Months Ended |
Jun. 30, 2014 | |
BUSINESS OVERVIEW | ' |
1. BUSINESS OVERVIEW | |
Overview | |
Idenix Pharmaceuticals, Inc., which we refer to together with our wholly owned subsidiaries as Idenix, we, us or our, is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases with operations in the United States and France. Currently, our primary research and development focus is on the treatment of patients with hepatitis C virus, or HCV, using nucleotide polymerase inhibitors and NS5A inhibitors. | |
On June 9, 2014, we announced that we had entered into an agreement and plan of merger, which we refer to as the merger agreement, with Merck & Co., Inc. and its wholly-owned subsidiary, Imperial Blue Corporation, which together we refer to as Merck. On June 20, 2014, pursuant to the merger agreement, Merck commenced a tender offer, which we refer to as the offer, to purchase all of our issued and outstanding shares of common stock for $24.50 per share in cash. Consummation of the offer is subject to customary closing conditions. The tender offer will expire on August 4, 2014. We expect that the transaction will be completed in August 2014, but there can be no assurance that the offer will close in this timeframe or at all. Upon consummation of the merger we anticipate incurring merger related costs including approximately $64.0 million payable to third-parties. Upon closing of the offer and subject to the terms of the merger agreement, we will become a wholly-owned subsidiary of Merck and our common stock will cease to trade on the NASDAQ Global Market. The foregoing description of the transaction with Merck does not purport to be complete and is qualified in its entirety by reference to the merger agreement, a copy of which was filed as Exhibit 2.1 on Form 8-K filed with the Securities and Exchange Commission, or SEC, on June 9, 2014. | |
In April 2014, we completed a seven-day proof-of-concept study of IDX21437, our lead uridine nucleotide prodrug candidate. IDX21437 monotherapy was well-tolerated and showed potent antiviral activity of mean maximal viral load reductions of 4.2 to 4.3 log10 IU/mL for patients infected with HCV genotype 1, 2 or 3 receiving 300 mg once-daily of IDX21437 for seven days. We expect to initiate an all-oral pan-genotypic combination phase II clinical trial of IDX21437 and samatasvir in mid-2014. | |
IDX21459 is our follow-on uridine-based nucleotide prodrug candidate that has shown a favorable preclinical profile including potent, pan-genotypic activity and favorable safety with respect to cardiac, mitochondrial and genotoxicity assessments. In April 2014, we initiated a phase I clinical trial in several countries outside the U.S. to evaluate IDX21459 in healthy volunteers and genotype 1 HCV-infected patients at multiple doses. | |
As part of our ongoing and extensive nucleotide discovery effort, we continue to explore and develop a diverse spectrum of nucleotides with novel bases, prodrugs and sugar moieties. Our discovery efforts are currently focused on the identification of a novel nucleotide prodrug with a distinct resistance profile from our clinical nucleotide candidates that can be used in a combination strategy to treat HCV. | |
In March 2014, we and certain co-owners were granted a European Patent, EP 1 523 489, that covers 2’-methyl-2’-fluoro nucleosides for treating HCV. Subsequently, we filed infringement lawsuits against Gilead Sciences, Inc., and/or certain of its subsidiaries, which we refer to as Gilead, in France, Germany and the United Kingdom. In these lawsuits, we are seeking remedies with respect to Gilead’s marketing and sales of drugs containing SovaldiTM, which we believe infringes our European patent. Gilead has counterclaimed for invalidity of our patent in certain of these jurisdictions. We also have several other legal matters ongoing with Gilead including infringement lawsuits in the U.S. and Canada, an ongoing interference case declared by the U.S. Patent and Trademark Office, or USPTO, and invalidity matters in other foreign jurisdictions. In March 2014, related to a Norway invalidity proceeding, the Oslo District Court determined that our patent NO 330 755 covering 2’-methyl-2’-fluoro nucleoside compounds useful in the treatment of HCV and other flaviviridae infections is invalid. We filed an appeal to challenge the court’s decision. The details of these ongoing legal matters are described more fully in Note 7. | |
In January 2014, we issued 16.4 million shares of our common stock to Baupost Group, L.L.C., a related party, through a registered direct offering under a shelf registration and received $106.6 million in net proceeds. We believe our current cash and cash equivalents will be sufficient to sustain operations into at least the second half of 2015. | |
Our drug development programs and the potential commercialization of our drug candidates will require substantial cash to fund costs that we incur in connection with preclinical studies and clinical trials, regulatory review, manufacturing and sales and marketing efforts. We have incurred losses in each year since our inception and at June 30, 2014, we had an accumulated deficit of $929.0 million. We expect to incur losses over the next several years as we continue to expand our drug discovery and development efforts. As a result of continuing losses, we may seek additional funding through a combination of public or private financing, collaborative relationships or other arrangements and we may seek a partner who will assist in the future development and commercialization of our drug candidates. | |
We are subject to risks common to companies in the biopharmaceutical industry including, but not limited to, the successful development of products, clinical trial uncertainty, regulatory approval, fluctuations in operating results and financial risks, potential need for additional funding, protection of proprietary technology and patent risks, compliance with government regulations, dependence on key personnel and collaboration partners, competition, technological and medical risks and management of growth. | |
Basis of Presentation | |
The condensed consolidated financial statements reflect the operations of Idenix Pharmaceuticals, Inc. and our wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. | |
The accompanying condensed consolidated financial statements are unaudited and have been prepared by us in accordance with generally accepted accounting principles in the United States of America, or GAAP, for interim reporting. Accordingly, these interim financial statements do not include all the information and footnotes required by GAAP for complete financial statements and should be read in conjunction with the audited consolidated financial statements for the year ended December 31, 2013, which are included in our Annual Report on Form 10-K filed with the SEC on February 27, 2014. These interim financial statements are unaudited, but in the opinion of management, reflect all adjustments (including normal recurring accruals) necessary for a fair statement of the financial position and results of operations for the interim periods presented. The year ended condensed consolidated balance sheet data presented for comparative purposes was derived from audited financial statements, but does not include all disclosures required by GAAP. | |
The preparation of condensed consolidated financial statements in accordance with GAAP requires management to make estimates and judgments that may affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosures of contingent assets and liabilities. On an on-going basis, we evaluate our estimates, judgments and methodologies, including those related to revenue recognition, accrued expenses, clinical trial expenses, impairment and amortization of long-lived assets, share-based compensation, income taxes including the valuation allowance for deferred tax assets, contingencies and litigation. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results may differ from these estimates under different assumptions or conditions. | |
The results of operations for the interim periods are not necessarily indicative of the results of operations to be expected for any future period or the fiscal year ending December 31, 2014. | |
Recent Accounting Pronouncements | |
In May 2014, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update 2014-09, Revenue from Contracts with Customers, or ASU 2014-09. ASU 2014-09 supersedes the revenue recognition requirements of FASB Accounting Standards Codification Topic 605, Revenue Recognition, or ASC Topic 605, and most industry-specific guidance throughout the ASC, resulting in the creation of FASB ASC Topic 606, Revenue from Contracts with Customers. ASU 2014-09 requires entities to recognize revenue in a way that depicts the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled to in exchange for those goods or services. ASU 2014-09 provides alternative methods of retrospective adoption and is effective for fiscal years, and interim periods within those years, beginning after December 15, 2016. Early adoption is not permitted. We are currently assessing the potential impact of adopting ASU 2014-09 on our financial statements and related disclosures. |
SUMMARY_OF_SIGNIFICANT_ACCOUNT
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 6 Months Ended |
Jun. 30, 2014 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ' |
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Revenue Recognition | |
Revenue is recognized in accordance with SEC Staff Accounting Bulletin No. 101, Revenue Recognition in Financial Statements, as amended by SEC Staff Accounting Bulletin No. 104, Revenue Recognition, and for revenue arrangements entered into after June 30, 2003, in accordance with the revenue recognition guidance of the Financial Accounting Standards Board, or FASB. For multiple-element revenue arrangements entered into or materially modified after January 1, 2011, we recognize revenue under ASC Topic 605. | |
We record revenue provided that there is persuasive evidence that an arrangement exists, delivery has occurred or services have been rendered, the price is fixed or determinable and collectability is reasonably assured. | |
Collaboration Revenue — Related Party | |
In July 2012, we executed a termination and revised relationship agreement, which we refer to as the termination agreement, with Novartis Pharma AG, or Novartis, which granted Novartis a non-exclusive license to conduct clinical trials evaluating a combination of any of our and Novartis’ HCV drug candidates after the HCV drug candidates have completed dose-ranging studies, subject to meeting certain criteria. The details of the termination agreement are described more fully in Note 6. We determined that the best estimate of selling price, or BESP, of Novartis’ non-exclusive license at July 31, 2012 was $5.0 million which is recognized as collaboration revenue from related party on a straight-line basis over the term of the non-exclusive license, or seven years. In establishing BESP for the non-exclusive license, we used a discounted cash flow model and considered the likelihood of our and Novartis’ drugs being commercialized, the development and commercialization timeline, discount rate, and probable treatment combination and associated peak sales figures which generate royalty amounts. As of June 30, 2014 and December 31, 2013, the remaining balances of $3.6 million and $4.0 million, respectively, were included in deferred revenue from related party in our condensed consolidated balance sheets. | |
Also under the collaboration, Novartis is entitled to stock subscription rights. If we issue any shares of capital stock, other than in limited situations, Novartis has the right to purchase such number of shares required to maintain its percentage ownership of our voting stock for either the same consideration per share paid by others acquiring our stock or, in specified situations, for a 10% premium to the consideration per share paid by others acquiring our stock. Novartis has the right to purchase shares of our common stock when stock options are exercised under certain plans. Commencing in August 2012, the fair value of our common stock that would be issuable to Novartis is recorded as an adjustment to the revenue recognized from the collaboration with Novartis and additional paid-in capital. The fair value of this stock subscription right is estimated on a quarterly basis using a trinomial lattice valuation model which includes inputs of our per share common stock price, exercise prices of outstanding options, expected term of our options and exercise rates as well as assumptions regarding expected volatility and exercise multiples. Our stock price as of the end of each fiscal quarter has a significant impact on the fair value calculation. Typically, if the stock price increases quarter over quarter, the fair value of Novartis’ stock subscription right increases and this increase in the fair value is recorded as a reduction to revenue in the quarter with a corresponding increase to additional paid-in capital. This may result in contra-revenue, or negative revenue, being recognized in any given fiscal period. This stock subscription right is described more fully in Note 6. | |
Cash and Cash Equivalents | |
We consider all highly liquid investments purchased with a maturity date of 90 days or less at the date of purchase to be cash equivalents. | |
In connection with certain of our operating lease commitments, we issued letters of credit collateralized by cash deposits that were classified as restricted cash on the condensed consolidated balance sheets. Restricted cash amounts have been classified as current assets based on the expected release date of the restrictions. | |
Concentration of Credit Risk | |
Financial instruments that potentially subject us to concentrations of credit risk primarily consist of cash and cash equivalents and receivables from related party. We invest our excess cash and cash equivalents in interest bearing accounts at major United States financial institutions. Management mitigates credit risk by limiting the investment type and maturity to securities that preserve capital, maintain liquidity and have a high credit quality. | |
At June 30, 2014 and December 31, 2013, all of our receivables from related party were due from Novartis related to Novartis’ commitment under the termination agreement to reimburse us for contractual payments due by us to third-parties (Note 7). | |
Fair Value Measurements | |
Our financial statements include assets and liabilities that are measured at fair value on a recurring basis as of June 30, 2014 and December 31, 2013. Fair values determined by Level 1 inputs utilize observable data such as quoted prices in active markets. Fair values determined by Level 2 inputs utilize data points other than quoted prices in active markets that are observable either directly or indirectly. Fair values determined by Level 3 inputs utilize unobservable data points in which there is little or no market data, which require the reporting entity to develop its own assumptions. | |
At June 30, 2014 and December 31, 2013, we had $120.7 million and $88.0 million, respectively, invested in money market funds. Our money market investments have calculated net asset values and are therefore classified as Level 2. There were no Level 3 assets held at fair value at June 30, 2014 or at December 31, 2013. There were no gross unrealized gains or losses for the three and six months ended June 30, 2014 or 2013. | |
Accrued Expenses | |
We accrue expenses we have incurred but have not been invoiced. This process involves estimating the level of service performed by third-parties on our behalf and the associated cost incurred for these services as of each balance sheet date in our financial statements. Examples of estimated accrued expenses in which subjective judgments may be required include services provided by contract organizations for preclinical development, clinical trials and manufacturing of clinical materials. Accruals for amounts due to clinical research organizations are among our most significant estimates. In connection with these service fees, our estimates are most affected by our understanding of the status and timing of services provided relative to the actual level of services incurred by the service providers. The date on which certain services commence, the level of services performed on or before a given date and the cost of services is often subject to our judgment. We make these judgments based upon the facts and circumstances known to us. Advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when payment is made. | |
Share-Based Compensation | |
We recognize share-based compensation for employees and directors using a grant date fair value based method that results in expense being recognized in our condensed consolidated financial statements. |
NET_LOSS_PER_COMMON_SHARE
NET LOSS PER COMMON SHARE | 6 Months Ended | ||||||||||||||||
Jun. 30, 2014 | |||||||||||||||||
NET LOSS PER COMMON SHARE | ' | ||||||||||||||||
3. NET LOSS PER COMMON SHARE | |||||||||||||||||
Basic net loss per common share is computed by dividing the net loss available to common stockholders by the weighted average number of common shares outstanding during the period. Diluted net loss per common share is computed by dividing the net loss available to common stockholders by the weighted average number of common shares and other potential common shares then outstanding. Potential common shares consist of common shares issuable upon the assumed exercise of outstanding stock options (using the treasury stock method) and the issuance of contingently issuable shares subject to Novartis’ stock subscription rights (Note 6) and restricted stock awards. | |||||||||||||||||
The following sets forth the computation of basic and diluted net loss per common share: | |||||||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
(In Thousands, Except | (In Thousands, Except | ||||||||||||||||
per Share Data) | per Share Data) | ||||||||||||||||
Basic and diluted net loss per common share: | |||||||||||||||||
Net loss | $ | (64,462 | ) | $ | (28,919 | ) | $ | (98,576 | ) | $ | (59,672 | ) | |||||
Basic and diluted weighted average number of common shares outstanding | 150,968 | 133,960 | 148,059 | 133,959 | |||||||||||||
Basic and diluted net loss per common share | $ | (0.43 | ) | $ | (0.22 | ) | $ | (0.67 | ) | $ | (0.45 | ) | |||||
The following potential common shares were excluded from the calculation of basic and diluted net loss per common share because their effect was anti-dilutive: | |||||||||||||||||
Three and Six Months Ended | |||||||||||||||||
June 30, | |||||||||||||||||
2014 | 2013 | ||||||||||||||||
(In Thousands) | |||||||||||||||||
Options | 8,188 | 7,671 | |||||||||||||||
Contingently issuable shares to related party | 2,202 | 511 | |||||||||||||||
10,390 | 8,182 | ||||||||||||||||
In addition to the contingently issuable shares to related party listed in the table above, Novartis could be entitled to additional shares under its stock subscription rights which would be anti-dilutive in future periods based on our current stock price. |
ACCRUED_EXPENSES
ACCRUED EXPENSES | 6 Months Ended | ||||||||
Jun. 30, 2014 | |||||||||
ACCRUED EXPENSES | ' | ||||||||
4. ACCRUED EXPENSES | |||||||||
Accrued expenses consisted of the following: | |||||||||
June 30, | December 31, | ||||||||
2014 | 2013 | ||||||||
(In Thousands) | |||||||||
Research and development contract costs | $ | 8,765 | $ | 2,832 | |||||
Payroll and benefits | 4,053 | 2,888 | |||||||
Professional fees | 4,955 | 992 | |||||||
Accrued settlement payment | 1,050 | 1,052 | |||||||
Other | 843 | 1,539 | |||||||
$ | 19,666 | $ | 9,303 | ||||||
Other long-term liabilities consisted of the following: | |||||||||
June 30, | December 31, | ||||||||
2014 | 2013 | ||||||||
(In Thousands) | |||||||||
Accrued settlement payment | $ | 4,555 | $ | 5,082 | |||||
Research and development contract costs | 3,278 | 3,278 | |||||||
Other | 1,407 | 918 | |||||||
$ | 9,240 | $ | 9,278 | ||||||
SHAREBASED_COMPENSATION
SHARE-BASED COMPENSATION | 6 Months Ended | ||||||||||||||||
Jun. 30, 2014 | |||||||||||||||||
SHARE-BASED COMPENSATION | ' | ||||||||||||||||
5. SHARE-BASED COMPENSATION | |||||||||||||||||
The following table shows share-based compensation expense as included in our condensed consolidated statements of operations and comprehensive loss: | |||||||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
(In Thousands) | (In Thousands) | ||||||||||||||||
Research and development | $ | 569 | $ | 525 | $ | 1,052 | $ | 995 | |||||||||
General and administrative | 1,083 | 861 | 2,030 | 1,640 | |||||||||||||
Total share-based compensation expense | $ | 1,652 | $ | 1,386 | $ | 3,082 | $ | 2,635 | |||||||||
The table below illustrates the fair value per share and Black-Scholes option pricing model with the following assumptions used for grants issued: | |||||||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
Weighted average fair value of options | $ | 5.11 | $ | 3.21 | $ | 4.77 | $ | 3.04 | |||||||||
Risk-free interest rate | 1.85 | % | 1.01 | % | 1.57 | % | 0.88 | % | |||||||||
Expected dividend yield | — | — | — | — | |||||||||||||
Expected option term (in years) | 6.42 | 5.27 | 5.41 | 5.27 | |||||||||||||
Expected volatility | 80.4 | % | 79.7 | % | 81.3 | % | 80.3 | % | |||||||||
The expected option term and expected volatility were determined by examining the expected option term and expected volatilities of similarly sized biotechnology companies as well as expected term and expected volatility of our own stock. During the three months ended June 30, 2014 certain options were granted with a contractual term of 10 years. | |||||||||||||||||
The following table summarizes option activity under the equity incentive plans: | |||||||||||||||||
Number of | Weighted | ||||||||||||||||
Shares | Average Exercise | ||||||||||||||||
Price per Share | |||||||||||||||||
Options outstanding at December 31, 2013 | 7,430,965 | $ | 6.67 | ||||||||||||||
Granted | 1,907,775 | $ | 7.15 | ||||||||||||||
Cancelled | (219,685 | ) | $ | 11.77 | |||||||||||||
Exercised | (930,564 | ) | $ | 6.96 | |||||||||||||
Options outstanding at June 30, 2014 | 8,188,491 | $ | 6.61 | ||||||||||||||
Options exercisable at June 30, 2014 | 4,912,218 | $ | 6.39 | ||||||||||||||
We had an aggregate of $15.1 million of share-based compensation expense as of June 30, 2014 remaining to be amortized over a weighted average expected term of 2.71 years. |
COLLABORATION
COLLABORATION | 6 Months Ended |
Jun. 30, 2014 | |
COLLABORATION | ' |
6. COLLABORATION | |
Janssen Pharmaceuticals, Inc. Collaboration | |
In January 2013, we entered into a non-exclusive collaboration agreement with Janssen Pharmaceuticals, Inc., or Janssen, for the clinical evaluation of all-oral direct acting antiviral, or DAA, HCV combination therapies. The combination therapies involve samatasvir, our once-daily pan-genotypic NS5A inhibitor, simeprevir, a once-daily protease inhibitor jointly developed by Janssen and Medivir AB, or Medivir, and TMC647055, a once-daily non-nucleoside polymerase inhibitor, with low dose ritonavir, being developed by Janssen. | |
Under the terms of this collaboration agreement, we are conducting the clinical trials. The collaboration includes two ongoing phase II clinical trials, which we refer to as HELIX-1 and HELIX-2. HELIX-1 is a 12-week phase II clinical trial evaluating samatasvir and simeprevir plus ribavirin in treatment-naïve genotype 1b or 4 HCV-infected patients. Interim data from HELIX-1 showed the regimen was well-tolerated and that in patients receiving 50 mg of samatasvir and 150 mg of simeprevir plus ribavirin, 85% had undetectable virus levels at four weeks after completing therapy, or SVR4. The 50 mg dose was advanced into the ongoing three-DAA HELIX-2 clinical trial which was initiated in the fourth quarter of 2013. This 12-week phase II HELIX-2 clinical trial is evaluating the three-DAA combination of samatasvir, simeprevir, and TMC647055 with low-dose ritonavir, with and without ribavirin, in genotype 1 HCV-infected patients who are either treatment-naïve or have relapsed after treatment with interferon and ribavirin. We expect to report rates of sustained virologic response, or SVR, data in the second half of 2014. | |
Under this collaboration agreement, the clinical trials are conducted whereby Janssen provides us with clinical supply of simeprevir and TMC647055 at no cost. Neither party will receive any milestone or royalty payments from the other party under this agreement. Both companies retain all rights to their respective compounds under this agreement. The parties have no obligation to conduct additional clinical trials beyond those described here. Neither party has licensed any commercial rights to the other party. | |
This collaboration agreement may be terminated by either party in certain circumstances. Janssen may terminate the collaboration agreement, in its sole discretion, by providing us with 30 days written notice. If Janssen terminates the collaboration agreement in such instance, it shall reimburse us for certain of our costs associated with the collaboration. | |
If either us or Janssen materially breaches the collaboration agreement and does not cure such breach within a specified time period, the non-breaching party may terminate the collaboration agreement in its entirety. Either party may also terminate the collaboration agreement, effective immediately, if the other party files for bankruptcy, is dissolved or has a receiver appointed for substantially all of its property. Either party may also terminate the collaboration agreement to protect the safety, health or welfare of subjects in the trials. We may terminate the collaboration agreement prior to the commencement of certain activities if Janssen’s research, development and license agreement with Medivir is terminated. | |
Novartis Collaboration | |
In May 2003, we entered into the development and commercialization agreement with Novartis related to the worldwide development and commercialization of our drug candidates. In May 2003, we also entered into the stockholders’ agreement with Novartis. In July 2012, we and Novartis materially modified our collaboration by executing the termination agreement and the second amended and restated stockholders’ agreement. As of July 23, 2014, Novartis owned approximately 22% of our outstanding common stock. | |
Termination Agreement | |
Pursuant to the termination agreement, we granted Novartis a non-exclusive license to conduct clinical trials evaluating a combination of any of our and Novartis’ HCV drug candidates after the HCV drug candidates have completed dose-ranging studies, subject to meeting certain criteria. Novartis’ ability to initiate combination trials expires on the seven year anniversary of the execution of the termination agreement, or July 2019, although any combination study commenced prior to such expiration date may continue after the expiration date. We determined the BESP of the non-exclusive license at July 31, 2012 to be $5.0 million which is recognized as revenue on a straight-line basis over the term of the non-exclusive license, or seven years. During each of the three and six months ended June 30, 2014 and 2013, we recognized $0.2 million and $0.4 million, respectively, of collaboration revenue related to the non-exclusive license. As of June 30, 2014 and December 31, 2013, we had a balance of $3.6 million and $4.0 million, respectively, of deferred revenue from related party in our condensed consolidated balance sheets. Collaboration revenue was also impacted by Novartis’ stock subscription rights described below. | |
If Novartis conducts a dose-ranging study with respect to our HCV drug candidates, we have agreed to supply Novartis with our HCV drug candidates for use in such combination trials. We and Novartis have agreed to use commercially reasonable efforts to, in good faith, enter into a supply agreement and other relevant agreements in connection with any such combination trial. Additionally, under the termination agreement, following the receipt of certain data related to a combination trial and upon Novartis’ request, we and Novartis are obligated to, in good faith, use commercially reasonable efforts to negotiate a future agreement for the development, manufacture and commercialization of such combination therapy for the treatment of HCV. Neither party is obligated to negotiate for a period longer than 180 days. | |
Under the termination agreement, Novartis’ option right to license our current and future development-stage drug candidates in any therapeutic area was terminated. In exchange, we agreed to pay Novartis a royalty based on worldwide product sales of our HCV drug products, unless such drug products are prescribed in combination with Novartis’ HCV drug products. The royalty percentage will vary based on our commercialized HCV drug product, but range from the high single digits to the low double digit percentages. Royalties are payable until the later to occur of: a) expiration of the last-to-expire of specified patent rights in a country; or b) ten years after the first commercial sale of a product in such country, provided that if royalties are payable on a product after the expiration of the patent rights in a country, each of the respective royalty rates for such product in such country would be reduced by one-half. | |
Under the termination agreement, we no longer receive royalty or milestone payments from Novartis based upon worldwide product sales of telbivudine (Tyzeka®/Sebivo®) for the treatment of hepatitis B virus, or HBV. Novartis is obligated to pay for our contractual payments to Le Centre National de la Recherche Scientifique, or CNRS, and the University of Alabama at Birmingham Research Foundation, or UABRF, in connection with intellectual property related to Tyzeka®/Sebivo®. We are otherwise responsible for any payments to third-parties in connection with intellectual property necessary to sell Tyzeka®/Sebivo®. | |
Termination or Breach by Either Party | |
If either we or Novartis materially breaches the termination agreement and does not cure such breach within 30 days, the non-breaching party may terminate this agreement in its entirety. Either party may also terminate this agreement, effective immediately, if the other party files for bankruptcy, is dissolved, or has a receiver appointed for substantially all of its property. Novartis may also terminate this agreement for convenience. If Novartis terminates this agreement either because of a material breach by us that has not been cured or because we have filed for bankruptcy, Novartis may, at its election, retain the licenses granted to it by us under the termination agreement to conduct clinical trials evaluating a combination of any of our HCV drug candidates and any of Novartis’ HCV drug candidates and we would remain obligated to make royalty payments to Novartis based on sales of our HCV drug products. If we terminate this agreement either because of a material breach by Novartis that has not been cured or because Novartis has filed for bankruptcy, or if Novartis terminates this agreement for convenience, the licenses granted to Novartis to conduct combination trials terminate and we would remain obligated to make royalty payments to Novartis based on sales of our HCV drug products. | |
Indemnification | |
We have agreed to indemnify Novartis and its affiliates against losses suffered as a result of our development, manufacture and commercialization of our HCV products. We have also agreed to indemnify Novartis and its affiliates against losses suffered as a result of any breach of representations and warranties in the termination agreement, the development and commercialization agreement and a stock purchase agreement entered into in 2003. Under these agreements with Novartis, we made numerous representations and warranties to Novartis regarding our drug candidates for the treatment of HBV and HCV, including representations regarding ownership of related inventions and discoveries. In the event of a breach of any such representation or warranty by us, Novartis has the right to seek indemnification from us and, under certain circumstances, our stockholders who sold shares to Novartis in 2003, which includes certain of our current and former directors and officers, for damages suffered by Novartis as a result of such breach. The amounts for which we and our stockholders could be liable to Novartis could be substantial. | |
Second Amended and Restated Stockholders’ Agreement | |
In May 2003, we entered into the stockholders’ agreement with Novartis and in July 2012, we amended this agreement by executing the second amended and restated stockholders’ agreement which includes the terms as described below. | |
Novartis’ Registration Rights and Corporate Governance Rights | |
Under the second amended and restated stockholders’ agreement, Novartis maintains its rights to cause us to register for resale, under the Securities Act of 1933, as amended, shares held by Novartis and/or its affiliates. | |
Under the second amended and restated stockholders’ agreement, we have agreed to use our reasonable best efforts to nominate for election one designee of Novartis for so long as Novartis and its affiliates own at least 15% of our voting stock. Novartis has the rights to appoint a non-voting observer to any committee of our board of directors. Novartis has no other corporate governance rights under the second amended and restated stockholders’ agreement. | |
Novartis’ Stock Subscription Rights | |
Under the second amended and restated stockholders’ agreement, if we issue any shares of capital stock, other than in limited situations, Novartis has the right to purchase such number of shares required to maintain its percentage ownership of our voting stock for either the same consideration per share paid by others acquiring our stock or, in specified situations, for a 10% premium to the consideration per share paid by others acquiring our stock. | |
Novartis has the right to purchase shares of our common stock when stock options are exercised under certain stock option plans. Commencing in August 2012, the fair value of our common stock that would be issuable to Novartis pursuant to this right is recorded as an adjustment to the revenue recognized from the collaboration with Novartis and additional paid-in capital. The fair value of this stock subscription right is estimated on a quarterly basis using a trinomial lattice valuation model which includes inputs of our per share common stock price, exercise prices of outstanding options, expected term of our options and exercise rates as well as assumptions regarding expected volatility and exercise multiples. Our stock price as of the end of each fiscal quarter has a significant impact on the fair value calculation. Typically, if the stock price increases quarter over quarter, the fair value of Novartis’ stock subscription right increases and this increase in the fair value is recorded as a reduction to revenue in the quarter with a corresponding increase to additional paid-in capital. This may result in contra-revenue, or negative revenue, being recognized in any given fiscal period. | |
For the three months ended June 30, 2014, the $26.2 million impact of Novartis’ stock subscription rights increased additional paid-in capital and reduced collaboration revenue. For the six months ended June 30, 2014, the $29.4 million impact of Novartis’ stock subscription rights increased additional paid-in capital and reduced collaboration revenue. |
COMMITMENTS_AND_CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 6 Months Ended |
Jun. 30, 2014 | |
COMMITMENTS AND CONTINGENCIES | ' |
7. COMMITMENTS AND CONTINGENCIES | |
Product and Drug Candidates | |
In connection with the resolution of matters relating to certain of our HCV drug candidates, in May 2004, we entered into a settlement agreement with the University of Alabama at Birmingham, or UAB, which provides for a milestone payment of $1.0 million to UAB upon receipt of regulatory approval in the United States to market and sell certain HCV products invented or discovered by our former chief executive officer during the period from November 1, 1999 to November 1, 2000. This settlement agreement also provides that we will pay UAB an amount equal to 0.5% of worldwide net sales of such HCV products with a minimum sales-based payment equal to $12.0 million. Such payments would be due even in the instance where we licensed such technology to a third-party. Currently, there are no such HCV products approved and therefore there was no related liability recorded as of June 30, 2014. | |
We have potential payment obligations under the license agreement with the Universita degli Studi di Cagliari, or the University of Cagliari, pursuant to which we have the exclusive worldwide right to make, use and sell certain HCV technologies and the right to sublicense any of those rights. If we receive license fees, milestone payments or any other payments with respect to technology licensed to us by the University of Cagliari, we must provide payments to the University of Cagliari. In addition, we will be liable to the University of Cagliari for a fixed royalty payment on worldwide sales of licensed drug products that derive from the specified patents. The license agreement terminates at the expiration of all royalty payment obligations, unless terminated earlier by us, by the mutual agreement of the parties or by a material breach of the terms of the agreement. | |
Pursuant to the license agreement between us and UAB, we were granted an exclusive license to the rights that the UABRF an affiliate of UAB, Emory University and CNRS have to a 1995 U.S. patent application and progeny thereof and counterpart patent applications in Europe, Canada, Japan and Australia that cover the use of certain synthetic nucleosides for the treatment of HBV. In July 2008, we entered into a settlement agreement with UAB, UABRF and Emory University relating to our telbivudine technology. Pursuant to this settlement agreement, all contractual disputes relating to patents covering the use of certain synthetic nucleosides for the treatment of HBV and all litigation matters relating to patents and patent applications related to the use of ß-L-2’-deoxy-nucleosides for the treatment of HBV assigned to one or more of Idenix, CNRS and L’Universite Montpellier II, or the University of Montpellier, and which cover the use of Tyzeka®/Sebivo® have been resolved. UAB also agreed to abandon certain continuation patent applications it filed in July 2005. Under the terms of the settlement agreement, we paid UABRF (on behalf of UAB and Emory University) a $4.0 million upfront payment and agreed to make additional payments to UABRF equal to 20% of all royalty payments received by us from Novartis from worldwide sales of Tyzeka®/Sebivo®, subject to minimum payment obligations aggregating $11.0 million. Our payment obligations under the settlement agreement expire in August 2019. The settlement agreement was effective on June 1, 2008 and included mutual releases of all claims and covenants not to sue among the parties. It also included a release from a third-party scientist who had claimed to have inventorship rights in certain Idenix/CNRS/University of Montpellier patents. Included in the condensed consolidated balance sheets as of June 30, 2014 and December 31, 2013 was a liability of $5.6 million and $6.1 million, respectively, related to this settlement agreement. Under the termination agreement executed in July 2012, we no longer receive royalty or milestone payments from Novartis based upon worldwide product sales of Tyzeka®/Sebivo®. Novartis is required to reimburse us for our contractual payments to UABRF in connection with our intellectual property related to Tyzeka®/Sebivo®. Included in receivables from related party at June 30, 2014 and December 2013 was $5.6 million and $6.1 million, respectively, for the reimbursement from Novartis for these contractual payments to UABRF. | |
In May 2003, we and Novartis entered into an amended and restated agreement with CNRS and the University of Montpellier. The agreement includes provisions relating to ownership and commercialization of the technology which is discovered or obtained as part of the collaboration as well as rights regarding ownership and use of such technology, including telbivudine, which remain in effect following termination or expiration of the agreement. Under the cooperative agreement, we are obligated to make royalty payments for products derived from such patents, including products for HCV. Such payments would be due even in the instance where we licensed such patents to a third-party. | |
Legal Contingency | |
The USPTO has declared two interferences between Idenix and Gilead. An interference proceeding is divided into two stages. The first phase determines the application filing dates each party will have benefit of for the interfering subject matter. The party with the benefit of the earliest application filing date is deemed the ‘senior party’ and the party with the later date is deemed the ‘junior party’. The second phase of the interference determines which party was first to invent. The party who is deemed first to invent prevails in the interference proceeding. Certain or all of the claims in a patent may be declared invalid if the party does not prevail in the interference. | |
In February 2012, the first interference was declared by the USPTO concerning our co-owned U.S. Patent Application 12/131,868 and Gilead’s U.S. Patent No. 7,429,572. Both the application and patent claim certain nucleoside compounds useful in treating HCV. In January 2014, the USPTO awarded Gilead priority of invention. We have challenged this decision outside the USPTO in the U.S. District Court for the District of Delaware. | |
In December 2013, the second interference was declared by the USPTO concerning our co-owned U.S. Patent No. 7,608,600 and Gilead’s U.S. Patent Application 11/854,218. Both the patent and application claim certain nucleoside compounds useful in treating HCV. In this case, the USPTO has initially determined that we are the ‘senior party’ and that Gilead is the ‘junior party’, although that determination may change after the first phase of the interference. We cannot predict if the decision in the first interference will influence the timing and/or outcome of the second interference. | |
In June 2012, Gilead filed suit against us in the Canadian Federal Court seeking to invalidate one of our issued co-owned Canadian patents. This patent covers similar subject matter to our U.S. Patent Application 12/131,868 and U.S. Patent No. 7,608,600. In April 2014, we counterclaimed for infringement against Gilead in Canada. Through this counterclaim we are seeking remedies with respect to Gilead’s marketing and sales of drugs containing Sovaldi™, which we believe infringes our Canadian patent. The Canadian patent involved covers similar subject matter to our U.S. Patent No. 7,608,600. | |
In September 2012, Gilead filed suit against us in Norway in the Oslo District Court seeking to invalidate one of our issued co-owned Norwegian patents. Our patent, NO 330 755, covers certain 2’-methyl-2’-fluoro nucleoside compounds useful in the treatment of HCV and other flaviviridae infections, which is similar subject matter to our U.S. Patent Application 12/131,868 and U.S. Patent No. 7,608,600. In March 2014, the Oslo District Court determined that our Norwegian patent, NO 330 755, is invalid. We filed an appeal to challenge the court’s decision. In the event we do not prevail in the appeals process, we may be liable for reimbursement of legal fees incurred by Gilead of an amount, if any, as determined by the Norway court. Accordingly, no estimate regarding the range of possible loss can be made for the reimbursement of legal fees. | |
In January 2013, Gilead commenced proceedings in the Federal Court of Australia seeking a declaration of certain claims of one of our issued co-owned Australian patents. This patent covers similar subject matter to our U.S. Patent Application 12/131,868 and U.S. Patent No. 7,608,600. | |
In August 2013, we filed a request with the Chinese Patent Office’s Patent Re-examination Board, or PRB, to invalidate Gilead’s Chinese Patent No. ZL.200480019148.4. Gilead’s patent relates to 2’-fluoro-2’-methyl-nucleoside compounds that are useful for treating HCV. The request alleges that Gilead’s patent is invalid for lack of novelty over a prior filed Idenix co-owned Chinese patent application. We cannot predict whether our request will be granted by the PRB. | |
In December 2013, we filed infringement lawsuits against Gilead in the U.S District Court for the District of Massachusetts and in U.S. District Court for the District of Delaware. In the Massachusetts action, we allege that Gilead’s method of treating HCV using its Sovaldi™ product infringes our two asserted co-owned patents, U.S. Patent Nos. 6,914,054 and 7,608,597. In the Delaware action, we allege that Gilead’s method of treating HCV using its Sovaldi™ product infringes our asserted co-owned patent U.S. Patent No. 7,608,600. The Massachusetts action has been transferred to the U.S. District Court for the District of Delaware. In these lawsuits, we are seeking remedies with respect to Gilead’s marketing and sales of drugs containing Sovaldi™, which we believe infringes our U.S. patents. In the Delaware action, we also filed an interference claim between our co-owned U.S. Patent No. 7,608,600 and Gilead’s U.S. Patent No. 8,415,322. As part of that claim, we are asking that our U.S. Patent No. 7,608,600 be deemed to have priority of invention over Gilead’s U.S. Patent No. 8,415,322. | |
In March 2014, we and certain co-owners were granted a European Patent, EP 1 523 489, that covers 2’-methyl-2’-fluoro nucleosides for treating HCV. Subsequently, we filed infringement lawsuits against Gilead in France, Germany and the United Kingdom. In these lawsuits, we are seeking remedies with respect to Gilead’s marketing and sales of drugs containing Sovaldi™, which we believe infringes our European patent. The European patent involved covers similar subject matter to our U.S. Patent No. 7,608,600. Gilead has counterclaimed for invalidity of our patent in certain of these jurisdictions. | |
While we cannot predict whether we will prevail, we intend to vigorously defend all of these actions described above and any others like it brought by a third-party. These legal proceedings are likely to be expensive and time consuming. We do not believe the patents at issue in these cases are relevant to any compounds we currently have under clinical development. In the event we do not prevail in certain jurisdictions, we may be liable for reimbursement of legal fees incurred by the other party. As of June 30, 2014, we have not recorded a liability associated with any of these legal matters as we do not consider a loss to be probable. | |
On June 16 2014, two cases were filed in the Court of Chancery of the State of Delaware against Idenix, our directors and certain officers, and Merck, captioned as follows: Ronald Burns, et. al. v. Idenix Pharmaceuticals, Inc., et. al., Case No. 9764-VCG (Del. Ch.) and Emin Dulger, et. al. v. Idenix Pharmaceuticals, Inc., et. al., Case No. 9767-VCG (Del. Ch.). The two cases are putative class actions brought by purported stockholders alleging, among other things, that our directors breached their fiduciary duties by approving the merger agreement, and that we and Merck aided and abetted these alleged breaches of fiduciary duty. Both complaints seek, among other things, either to enjoin the proposed transaction or to rescind it should it be consummated, as well as money damages. | |
On June 26, 2014, a case was filed in the Trial Court of the Commonwealth of Massachusetts, Superior Court Department, for Suffolk County against Idenix, our directors, and Merck, captioned as follows: Bill Lioio, et. al. v. Idenix Pharmaceuticals, Inc., et. al., Docket No. B.L.S. 14-2010. This case is a putative class action brought by purported stockholders alleging, among other things, that our directors breached their fiduciary duties by approving the merger agreement, and that Merck aided and abetted these alleged breaches of fiduciary duty. The complaint seeks, among other things, either to enjoin the proposed transaction or to rescind it should it be consummated, as well as money damages. | |
On July 2, 2014, another case was filed in the Court of Chancery of the State of Delaware against Idenix, our directors, and Merck, captioned as follows: David Wohlberg, et. al. v. Idenix Pharmaceuticals, Inc., et. al., Case No. 9854 (Del. Ch.). This case is a putative class action brought by purported stockholders alleging, among other things, that our directors breached their fiduciary duties by approving the merger agreement and issuing a materially false and misleading Schedule 14D-9, and that Idenix and Merck aided and abetted these alleged breaches of fiduciary duty. This complaint seeks, among other things, either to enjoin the proposed transaction or to rescind it should it be consummated, as well as money damages. | |
On July 24, 2014, we, the members of our board of directors and Merck entered into a memorandum of understanding, which we refer to as the MOU, with the plaintiffs in the above-captioned actions reflecting an agreement in principle to settle the actions based on the agreement to include certain additional disclosures relating to the offer and the merger in our public filings. As defendants in the actions, to eliminate the burden, expense, distraction and uncertainties inherent in further litigation, and without admitting the validity of any allegation made in such actions, or any liability with respect thereto, we have concluded that it is desirable that the claims against us be settled on the terms reflected in the MOU. The terms of the settlement reflected in the MOU are subject to customary conditions including completion of appropriate settlement documentation, court approval and consummation of the offer and the merger. | |
The MOU provides that all actions will be dismissed with prejudice as to all defendants. Pursuant to the terms of the MOU, the parties expect to execute a stipulation of settlement, which will be subject to approval by the court, following notice to holders of shares of our common stock. There can be no assurance that the settlement will be finalized or that the court will approve the settlement. No amount of loss or range of possible loss can be reasonably estimated therefore at June 30, 2014, we have not recorded a liability associated with any of these legal matters. | |
Indemnification | |
We have agreed to indemnify Novartis and its affiliates against losses suffered as a result of the development, manufacture and commercialization of our HCV products. We have also agreed to indemnify Novartis and its affiliates against losses suffered as a result of any breach of representations and warranties in the termination agreement, development and commercialization agreement and the stock purchase agreement. Under these agreements with Novartis, we made numerous representations and warranties to Novartis regarding our HBV and HCV drug candidates, including representations regarding our ownership of the inventions and discoveries. In the event of a breach of any such representation or warranty by us, Novartis has the right to seek indemnification from us and, under certain circumstances, from our stockholders who sold shares to Novartis in 2003, which includes some of our current and former directors and officers, for damages suffered by Novartis as a result of such breach. The amounts for which we and our stockholders could be liable to Novartis could be substantial. While it is possible that we may be required to make payments pursuant to the indemnification obligations we have under these agreements, we cannot reasonably estimate the amount of such payments or the likelihood that such payments would be required. | |
Under the Janssen collaboration agreement, we agreed to indemnify Janssen against losses suffered as a result of a breach of representations and warranties in the agreement and/or any injury to a subject in a clinical trial under the collaboration agreement caused by the use or manufacture of samatasvir. We made numerous representations and warranties to Janssen. If one or more of these representations or warranties were not true at the time they were made, we would be in breach of the agreement. In the event of a breach by us or in the event of injury to a subject in a clinical trial under the collaboration agreement caused by the use or manufacture of samatasvir, Janssen has the right to seek indemnification from us for damages suffered as a result of such breach or subject injury. The amounts for which we could be liable to Janssen under these circumstances may be substantial. In the instance where a subject in a clinical trial suffers injury or death and it is not determinable which compound caused the injury or death, each party shall be responsible for defending any third-party claims alleged against the party after the application of our clinical trial insurance, to the extent applicable. |
SUMMARY_OF_SIGNIFICANT_ACCOUNT1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 6 Months Ended |
Jun. 30, 2014 | |
Revenue Recognition | ' |
Revenue Recognition | |
Revenue is recognized in accordance with SEC Staff Accounting Bulletin No. 101, Revenue Recognition in Financial Statements, as amended by SEC Staff Accounting Bulletin No. 104, Revenue Recognition, and for revenue arrangements entered into after June 30, 2003, in accordance with the revenue recognition guidance of the Financial Accounting Standards Board, or FASB. For multiple-element revenue arrangements entered into or materially modified after January 1, 2011, we recognize revenue under ASC Topic 605. | |
We record revenue provided that there is persuasive evidence that an arrangement exists, delivery has occurred or services have been rendered, the price is fixed or determinable and collectability is reasonably assured. | |
Collaboration Revenue — Related Party | |
In July 2012, we executed a termination and revised relationship agreement, which we refer to as the termination agreement, with Novartis Pharma AG, or Novartis, which granted Novartis a non-exclusive license to conduct clinical trials evaluating a combination of any of our and Novartis’ HCV drug candidates after the HCV drug candidates have completed dose-ranging studies, subject to meeting certain criteria. The details of the termination agreement are described more fully in Note 6. We determined that the best estimate of selling price, or BESP, of Novartis’ non-exclusive license at July 31, 2012 was $5.0 million which is recognized as collaboration revenue from related party on a straight-line basis over the term of the non-exclusive license, or seven years. In establishing BESP for the non-exclusive license, we used a discounted cash flow model and considered the likelihood of our and Novartis’ drugs being commercialized, the development and commercialization timeline, discount rate, and probable treatment combination and associated peak sales figures which generate royalty amounts. As of June 30, 2014 and December 31, 2013, the remaining balances of $3.6 million and $4.0 million, respectively, were included in deferred revenue from related party in our condensed consolidated balance sheets. | |
Also under the collaboration, Novartis is entitled to stock subscription rights. If we issue any shares of capital stock, other than in limited situations, Novartis has the right to purchase such number of shares required to maintain its percentage ownership of our voting stock for either the same consideration per share paid by others acquiring our stock or, in specified situations, for a 10% premium to the consideration per share paid by others acquiring our stock. Novartis has the right to purchase shares of our common stock when stock options are exercised under certain plans. Commencing in August 2012, the fair value of our common stock that would be issuable to Novartis is recorded as an adjustment to the revenue recognized from the collaboration with Novartis and additional paid-in capital. The fair value of this stock subscription right is estimated on a quarterly basis using a trinomial lattice valuation model which includes inputs of our per share common stock price, exercise prices of outstanding options, expected term of our options and exercise rates as well as assumptions regarding expected volatility and exercise multiples. Our stock price as of the end of each fiscal quarter has a significant impact on the fair value calculation. Typically, if the stock price increases quarter over quarter, the fair value of Novartis’ stock subscription right increases and this increase in the fair value is recorded as a reduction to revenue in the quarter with a corresponding increase to additional paid-in capital. This may result in contra-revenue, or negative revenue, being recognized in any given fiscal period. This stock subscription right is described more fully in Note 6. | |
Cash and Cash Equivalents | ' |
Cash and Cash Equivalents | |
We consider all highly liquid investments purchased with a maturity date of 90 days or less at the date of purchase to be cash equivalents. | |
In connection with certain of our operating lease commitments, we issued letters of credit collateralized by cash deposits that were classified as restricted cash on the condensed consolidated balance sheets. Restricted cash amounts have been classified as current assets based on the expected release date of the restrictions. | |
Concentration of Credit Risk | ' |
Concentration of Credit Risk | |
Financial instruments that potentially subject us to concentrations of credit risk primarily consist of cash and cash equivalents and receivables from related party. We invest our excess cash and cash equivalents in interest bearing accounts at major United States financial institutions. Management mitigates credit risk by limiting the investment type and maturity to securities that preserve capital, maintain liquidity and have a high credit quality. | |
At June 30, 2014 and December 31, 2013, all of our receivables from related party were due from Novartis related to Novartis’ commitment under the termination agreement to reimburse us for contractual payments due by us to third-parties (Note 7). | |
Fair Value Measurements | ' |
Fair Value Measurements | |
Our financial statements include assets and liabilities that are measured at fair value on a recurring basis as of June 30, 2014 and December 31, 2013. Fair values determined by Level 1 inputs utilize observable data such as quoted prices in active markets. Fair values determined by Level 2 inputs utilize data points other than quoted prices in active markets that are observable either directly or indirectly. Fair values determined by Level 3 inputs utilize unobservable data points in which there is little or no market data, which require the reporting entity to develop its own assumptions. | |
At June 30, 2014 and December 31, 2013, we had $120.7 million and $88.0 million, respectively, invested in money market funds. Our money market investments have calculated net asset values and are therefore classified as Level 2. There were no Level 3 assets held at fair value at June 30, 2014 or at December 31, 2013. There were no gross unrealized gains or losses for the three and six months ended June 30, 2014 or 2013. | |
Accrued Expenses | ' |
Accrued Expenses | |
We accrue expenses we have incurred but have not been invoiced. This process involves estimating the level of service performed by third-parties on our behalf and the associated cost incurred for these services as of each balance sheet date in our financial statements. Examples of estimated accrued expenses in which subjective judgments may be required include services provided by contract organizations for preclinical development, clinical trials and manufacturing of clinical materials. Accruals for amounts due to clinical research organizations are among our most significant estimates. In connection with these service fees, our estimates are most affected by our understanding of the status and timing of services provided relative to the actual level of services incurred by the service providers. The date on which certain services commence, the level of services performed on or before a given date and the cost of services is often subject to our judgment. We make these judgments based upon the facts and circumstances known to us. Advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when payment is made. | |
Share-Based Compensation | ' |
Share-Based Compensation | |
We recognize share-based compensation for employees and directors using a grant date fair value based method that results in expense being recognized in our condensed consolidated financial statements. |
NET_LOSS_PER_COMMON_SHARE_Tabl
NET LOSS PER COMMON SHARE (Tables) | 6 Months Ended | ||||||||||||||||
Jun. 30, 2014 | |||||||||||||||||
Basic and Diluted Net Loss per Common Share | ' | ||||||||||||||||
The following sets forth the computation of basic and diluted net loss per common share: | |||||||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
(In Thousands, Except | (In Thousands, Except | ||||||||||||||||
per Share Data) | per Share Data) | ||||||||||||||||
Basic and diluted net loss per common share: | |||||||||||||||||
Net loss | $ | (64,462 | ) | $ | (28,919 | ) | $ | (98,576 | ) | $ | (59,672 | ) | |||||
Basic and diluted weighted average number of common shares outstanding | 150,968 | 133,960 | 148,059 | 133,959 | |||||||||||||
Basic and diluted net loss per common share | $ | (0.43 | ) | $ | (0.22 | ) | $ | (0.67 | ) | $ | (0.45 | ) | |||||
Common Shares Excluded from Calculation of Basic and Diluted Net Loss per Common Share | ' | ||||||||||||||||
The following potential common shares were excluded from the calculation of basic and diluted net loss per common share because their effect was anti-dilutive: | |||||||||||||||||
Three and Six Months Ended | |||||||||||||||||
June 30, | |||||||||||||||||
2014 | 2013 | ||||||||||||||||
(In Thousands) | |||||||||||||||||
Options | 8,188 | 7,671 | |||||||||||||||
Contingently issuable shares to related party | 2,202 | 511 | |||||||||||||||
10,390 | 8,182 | ||||||||||||||||
ACCRUED_EXPENSES_Tables
ACCRUED EXPENSES (Tables) | 6 Months Ended | ||||||||
Jun. 30, 2014 | |||||||||
Component of Accrued Expenses | ' | ||||||||
Accrued expenses consisted of the following: | |||||||||
June 30, | December 31, | ||||||||
2014 | 2013 | ||||||||
(In Thousands) | |||||||||
Research and development contract costs | $ | 8,765 | $ | 2,832 | |||||
Payroll and benefits | 4,053 | 2,888 | |||||||
Professional fees | 4,955 | 992 | |||||||
Accrued settlement payment | 1,050 | 1,052 | |||||||
Other | 843 | 1,539 | |||||||
$ | 19,666 | $ | 9,303 | ||||||
Other Long-Term Liabilities | ' | ||||||||
Other long-term liabilities consisted of the following: | |||||||||
June 30, | December 31, | ||||||||
2014 | 2013 | ||||||||
(In Thousands) | |||||||||
Accrued settlement payment | $ | 4,555 | $ | 5,082 | |||||
Research and development contract costs | 3,278 | 3,278 | |||||||
Other | 1,407 | 918 | |||||||
$ | 9,240 | $ | 9,278 | ||||||
SHAREBASED_COMPENSATION_Tables
SHARE-BASED COMPENSATION (Tables) | 6 Months Ended | ||||||||||||||||
Jun. 30, 2014 | |||||||||||||||||
Share-Based Compensation Expense | ' | ||||||||||||||||
The following table shows share-based compensation expense as included in our condensed consolidated statements of operations and comprehensive loss: | |||||||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
(In Thousands) | (In Thousands) | ||||||||||||||||
Research and development | $ | 569 | $ | 525 | $ | 1,052 | $ | 995 | |||||||||
General and administrative | 1,083 | 861 | 2,030 | 1,640 | |||||||||||||
Total share-based compensation expense | $ | 1,652 | $ | 1,386 | $ | 3,082 | $ | 2,635 | |||||||||
Fair Value per Share and Black-Scholes Option Pricing Model with Assumptions Used for Grants Issued | ' | ||||||||||||||||
The table below illustrates the fair value per share and Black-Scholes option pricing model with the following assumptions used for grants issued: | |||||||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
Weighted average fair value of options | $ | 5.11 | $ | 3.21 | $ | 4.77 | $ | 3.04 | |||||||||
Risk-free interest rate | 1.85 | % | 1.01 | % | 1.57 | % | 0.88 | % | |||||||||
Expected dividend yield | — | — | — | — | |||||||||||||
Expected option term (in years) | 6.42 | 5.27 | 5.41 | 5.27 | |||||||||||||
Expected volatility | 80.4 | % | 79.7 | % | 81.3 | % | 80.3 | % | |||||||||
Summary of Option Activity under Equity Incentive Plans | ' | ||||||||||||||||
The following table summarizes option activity under the equity incentive plans: | |||||||||||||||||
Number of | Weighted | ||||||||||||||||
Shares | Average Exercise | ||||||||||||||||
Price per Share | |||||||||||||||||
Options outstanding at December 31, 2013 | 7,430,965 | $ | 6.67 | ||||||||||||||
Granted | 1,907,775 | $ | 7.15 | ||||||||||||||
Cancelled | (219,685 | ) | $ | 11.77 | |||||||||||||
Exercised | (930,564 | ) | $ | 6.96 | |||||||||||||
Options outstanding at June 30, 2014 | 8,188,491 | $ | 6.61 | ||||||||||||||
Options exercisable at June 30, 2014 | 4,912,218 | $ | 6.39 |
Business_Overview_Additional_I
Business Overview - Additional Information (Detail) (USD $) | 6 Months Ended | 1 Months Ended | ||
Share data in Millions, except Per Share data, unless otherwise specified | Jun. 30, 2014 | Dec. 31, 2013 | Jun. 20, 2014 | Jan. 31, 2014 |
Merck Tender Offer Proposal | The Baupost Group, L.L.C | |||
Nature Of Operations [Line Items] | ' | ' | ' | ' |
Merger agreement offer to purchase issued and outstanding stock price per share | ' | ' | $24.50 | ' |
Merger related costs | ' | ' | $64,000,000 | ' |
Shares of common stock issued pursuant to underwritten offering | ' | ' | ' | 16.4 |
Proceeds from issuance of common stock, net of offering costs | 106,590,000 | ' | ' | 106,590,000 |
Accumulated deficit | ($928,978,000) | ($830,402,000) | ' | ' |
Recovered_Sheet1
Summary of Significant Accounting Policies - Additional Information (Detail) (USD $) | 3 Months Ended | 6 Months Ended | 12 Months Ended | 1 Months Ended | 6 Months Ended | |||
In Millions, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2014 | Dec. 31, 2013 | Jun. 30, 2014 | Jul. 31, 2012 | Jul. 31, 2012 | Jun. 30, 2014 | Dec. 31, 2013 |
Novartis | Novartis | Novartis non-exclusive license to conduct combination trials | Novartis non-exclusive license to conduct combination trials | Novartis non-exclusive license to conduct combination trials | ||||
Schedule Of Significant Accounting Policies [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' |
Deferred revenue, related party | ' | ' | ' | ' | ' | $5 | $3.60 | $4 |
Terms of the termination and revised relationship agreement with a related party | ' | ' | ' | ' | ' | '7 years | '7 years | ' |
Percentage premium to the consideration per share paid by others for related party to purchase shares | ' | ' | ' | 10.00% | 10.00% | ' | ' | ' |
Maturity period of cash and cash equivalents | ' | '90 days | ' | ' | ' | ' | ' | ' |
Fair value of cash and cash equivalents | 120.7 | 120.7 | 88 | ' | ' | ' | ' | ' |
Level 3 assets held at fair value | 0 | 0 | 0 | ' | ' | ' | ' | ' |
Gross unrealized gains or losses in fair value | $0 | $0 | $0 | ' | ' | ' | ' | ' |
Basic_and_Diluted_Net_Loss_Per
Basic and Diluted Net Loss Per Common Share (Detail) (USD $) | 3 Months Ended | 6 Months Ended | ||
In Thousands, except Per Share data, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 |
Basic and diluted net loss per common share: | ' | ' | ' | ' |
Net loss | ($64,462) | ($28,919) | ($98,576) | ($59,672) |
Basic and diluted weighted average number of common shares outstanding | 150,968 | 133,960 | 148,059 | 133,959 |
Basic and diluted net loss per common share | ($0.43) | ($0.22) | ($0.67) | ($0.45) |
Common_Shares_Excluded_from_Ca
Common Shares Excluded from Calculation of Basic and Diluted Net Loss Per Common Share (Detail) | 3 Months Ended | 6 Months Ended |
In Thousands, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ' | ' |
Contingently issuable shares to a related party excluded from calculation of earnings per common share | 2,202 | 511 |
Antidilutive securities excluded from computation of earnings per share amount | 10,390 | 8,182 |
Option | ' | ' |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ' | ' |
Antidilutive securities excluded from computation of earnings per share amount | 8,188 | 7,671 |
Component_of_Accrued_Expenses_
Component of Accrued Expenses (Detail) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Schedule of Accrued Liabilities [Line Items] | ' | ' |
Research and development contract costs | $8,765 | $2,832 |
Payroll and benefits | 4,053 | 2,888 |
Professional fees | 4,955 | 992 |
Accrued settlement payment | 1,050 | 1,052 |
Other | 843 | 1,539 |
Total accrued expenses | $19,666 | $9,303 |
Other_LongTerm_Liabilities_Det
Other Long-Term Liabilities (Detail) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Other Non Current Liabilities [Line Items] | ' | ' |
Accrued settlement payment | $4,555 | $5,082 |
Research and development contract costs | 3,278 | 3,278 |
Other | 1,407 | 918 |
Other long-term liabilities | $9,240 | $9,278 |
ShareBased_Compensation_Expens
Share-Based Compensation Expense (Detail) (USD $) | 3 Months Ended | 6 Months Ended | ||
In Thousands, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' | ' |
Share-based compensation expense | $1,652 | $1,386 | $3,082 | $2,635 |
Research and development | ' | ' | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' | ' |
Share-based compensation expense | 569 | 525 | 1,052 | 995 |
General and administrative | ' | ' | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' | ' |
Share-based compensation expense | $1,083 | $861 | $2,030 | $1,640 |
Fair_Value_Per_Share_and_Black
Fair Value Per Share and Black-Scholes Option Pricing Model with Assumptions Used for Grants Issued (Detail) (USD $) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' | ' |
Weighted average fair value of options | $5.11 | $3.21 | $4.77 | $3.04 |
Risk-free interest rate | 1.85% | 1.01% | 1.57% | 0.88% |
Expected dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Expected option term | '6 years 5 months 1 day | '5 years 3 months 7 days | '5 years 4 months 28 days | '5 years 3 months 7 days |
Expected volatility | 80.40% | 79.70% | 81.30% | 80.30% |
ShareBased_Compensation_Additi
Share-Based Compensation - Additional Information (Detail) (USD $) | 3 Months Ended | 6 Months Ended |
In Millions, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2014 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' |
Expected option term | '10 years | ' |
Share-based compensation expense remaining to be amortized | $15.10 | $15.10 |
Weighted average expected term | ' | '2 years 8 months 16 days |
Summary_of_Option_Activity_und
Summary of Option Activity under Equity Incentive Plans (Detail) (USD $) | 6 Months Ended |
Jun. 30, 2014 | |
Number of Shares | ' |
Options outstanding, Beginning Balance | 7,430,965 |
Granted | 1,907,775 |
Cancelled | -219,685 |
Exercised | -930,564 |
Options outstanding, Ending Balance | 8,188,491 |
Options exercisable, at end of the period | 4,912,218 |
Weighted Average Exercise Price per Share | ' |
Options outstanding, Beginning Balance | $6.67 |
Granted | $7.15 |
Cancelled | $11.77 |
Exercised | $6.96 |
Options outstanding, Ending Balance | $6.61 |
Exercisable at end of the period | $6.39 |
Collaboration_Additional_Infor
Collaboration - Additional Information (Detail) (USD $) | 3 Months Ended | 6 Months Ended | 3 Months Ended | 6 Months Ended | 1 Months Ended | 6 Months Ended | 3 Months Ended | 6 Months Ended | |||||||
Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2014 | Jul. 31, 2012 | Jul. 23, 2014 | Jul. 31, 2012 | Jun. 30, 2014 | Dec. 31, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | |
Novartis | Novartis | Novartis | Novartis | Novartis non-exclusive license to conduct combination trials | Novartis non-exclusive license to conduct combination trials | Novartis non-exclusive license to conduct combination trials | Novartis non-exclusive license to conduct combination trials | Novartis non-exclusive license to conduct combination trials | Novartis non-exclusive license to conduct combination trials | Novartis non-exclusive license to conduct combination trials | |||||
Subsequent Event | Collaboration revenue related to the non-exclusive license | Collaboration revenue related to the non-exclusive license | Collaboration revenue related to the non-exclusive license | Collaboration revenue related to the non-exclusive license | |||||||||||
Collaboration Agreements [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Common stock outstanding, ownership percentage | ' | ' | ' | ' | ' | ' | ' | 22.00% | ' | ' | ' | ' | ' | ' | ' |
Deferred revenue, related party | ' | ' | ' | ' | ' | ' | ' | ' | $5,000,000 | $3,600,000 | $4,000,000 | ' | ' | ' | ' |
Terms of the termination and revised relationship agreement with a related party | ' | ' | ' | ' | ' | ' | ' | ' | '7 years | '7 years | ' | ' | ' | ' | ' |
Deferred revenue, related party, recognized | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 200,000 | 400,000 | 200,000 | 400,000 |
Negotiation obligation period for parties | ' | ' | ' | ' | ' | '180 days | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Term, in years, through which royalties are payable to a related party | ' | ' | ' | ' | ' | 'Royalties are payable until the later to occur of a) expiration of the last-to-expire of specified patent rights in a country; or b) ten years after the first commercial sale of a product in such country, provided that if royalties are payable on a product after the expiration of the patent rights in a country, each of the respective royalty rates for such product in such country would be reduced by one-half. | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Breach of termination agreement, maximum days to cure | ' | ' | ' | ' | ' | '30 days | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Minimum percentage of voting stock owned by related party to nominate for election as director at least one related party designee | ' | ' | ' | ' | ' | ' | 15.00% | ' | ' | ' | ' | ' | ' | ' | ' |
Percentage premium to the consideration per share paid by others for related party to purchase shares | ' | ' | ' | ' | 10.00% | 10.00% | 10.00% | ' | ' | ' | ' | ' | ' | ' | ' |
Impact on additional paid-in capital as a result of related party's stock subscription rights | ' | ' | ' | ' | 26,200,000 | 29,400,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Collaboration revenue - related party | ($26,071,000) | $112,000 | ($29,078,000) | $964,000 | ($26,200,000) | ($29,400,000) | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Commitments_and_Contingencies_
Commitments and Contingencies - Additional Information (Detail) (USD $) | 1 Months Ended | 6 Months Ended | 1 Months Ended | ||||
In Millions, unless otherwise specified | 31-May-04 | Jun. 30, 2014 | Jul. 31, 2008 | Jul. 31, 2008 | Jul. 31, 2008 | Jun. 30, 2014 | Dec. 31, 2013 |
UABRF | UABRF | UABRF | Novartis Reimbursement | Novartis Reimbursement | |||
Up Front Payment | Additional Payment | University Of Alabama At Birmingham | University Of Alabama At Birmingham | ||||
Commitments and Contingencies Disclosure [Line Items] | ' | ' | ' | ' | ' | ' | ' |
Potential milestone payment related to a settlement agreement with a third-party | $1 | ' | ' | ' | ' | ' | ' |
Percentage of payments made towards settlement agreement on net sales | ' | 0.50% | ' | ' | ' | ' | ' |
Minimum sales-based payment pursuant to settlement agreement | ' | 12 | ' | ' | ' | ' | ' |
Liability recorded as result of settlement agreement | ' | 0 | ' | ' | ' | ' | ' |
Intangible asset, net | ' | ' | ' | 4 | 11 | ' | ' |
Percentage of payments to third-party based on royalties received from related party | ' | ' | 20.00% | ' | ' | ' | ' |
Related party transaction, due from (to) related party | ' | ' | ' | ' | ' | $5.60 | $6.10 |
Settlement agreement related to intangible asset, expiration date | ' | ' | '2019-08 | ' | ' | ' | ' |