Document_And_Entity_Informatio
Document And Entity Information | 6 Months Ended | |
Jun. 30, 2014 | Jul. 25, 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 | ' |
Entity Registrant Name | 'DYAX CORP | ' |
Entity Central Index Key | '0000907562 | ' |
Current Fiscal Year End Date | '--12-31 | ' |
Entity Filer Category | 'Accelerated Filer | ' |
Trading Symbol | 'DYAX | ' |
Entity Common Stock, Shares Outstanding | ' | 136,205,351 |
Consolidated_Balance_Sheets
Consolidated Balance Sheets (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Current assets: | ' | ' |
Cash and cash equivalents | $30,011 | $68,085 |
Short-term investments | 157,688 | 43,296 |
Accounts receivable, net | 5,243 | 6,506 |
Inventory | 3,224 | 2,827 |
Other current assets | 1,842 | 1,618 |
Total current assets | 198,008 | 122,332 |
Fixed assets, net | 4,677 | 4,960 |
Restricted cash | 1,100 | 1,100 |
Other assets | 4,839 | 5,815 |
Total assets | 208,624 | 134,207 |
Current liabilities: | ' | ' |
Accounts payable and accrued expenses | 10,469 | 12,542 |
Current portion of deferred revenue | 2,423 | 2,686 |
Current portion of long-term obligations | 487 | 468 |
Other current liabilities | 2,342 | 1,812 |
Total current liabilities | 15,721 | 17,508 |
Deferred revenue | 4,915 | 5,335 |
Notes payable | 81,839 | 81,516 |
Long-term obligations | 212 | 463 |
Deferred rent and other long-term liabilities | 2,983 | 3,063 |
Total liabilities | 105,670 | 107,885 |
Commitments and contingencies | ' | ' |
Stockholders' equity: | ' | ' |
Preferred stock, $0.01 par value; 1,000,000 shares authorized; 0 and 41,418 shares issued and outstanding at June 30, 2014 and December 31, 2013, respectively | 0 | 0 |
Common stock, $0.01 par value; 200,000,000 shares authorized; 136,032,792 and 121,704,480 shares issued and outstanding at June 30, 2014 and December 31, 2013, respectively | 1,360 | 1,217 |
Additional paid-in capital | 644,236 | 559,065 |
Accumulated deficit | -542,735 | -533,963 |
Accumulated other comprehensive income | 93 | 3 |
Total stockholders' equity | 102,954 | 26,322 |
Total liabilities and stockholders' equity | $208,624 | $134,207 |
Consolidated_Balance_Sheets_Pa
Consolidated Balance Sheets (Parenthetical) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
Preferred stock, par value | $0.01 | $0.01 |
Preferred stock, shares authorized | 1,000,000 | 1,000,000 |
Preferred stock, shares issued | 0 | 41,418 |
Preferred stock, shares outstanding | 0 | 41,418 |
Common stock, par value | $0.01 | $0.01 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 136,032,792 | 121,704,480 |
Common stock, shares outstanding | 136,032,792 | 121,704,480 |
Consolidated_Statements_of_Ope
Consolidated Statements of Operations and Comprehensive Loss (USD $) | 3 Months Ended | 6 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 |
Revenues: | ' | ' | ' | ' |
Product sales, net | $16,582 | $8,568 | $29,089 | $17,155 |
Development and license fee revenues | 3,003 | 2,768 | 4,613 | 6,221 |
Total revenues, net | 19,585 | 11,336 | 33,702 | 23,376 |
Costs and expenses: | ' | ' | ' | ' |
Cost of product sales | 975 | 563 | 1,760 | 1,271 |
Research and development | 8,456 | 6,450 | 15,325 | 15,121 |
Selling, general and administrative | 10,565 | 10,173 | 20,054 | 21,297 |
Total costs and expenses | 19,996 | 17,186 | 37,139 | 37,689 |
Loss from operations | -411 | -5,850 | -3,437 | -14,313 |
Other income (expense): | ' | ' | ' | ' |
Interest income | 73 | 4 | 111 | 9 |
Interest and other expenses | -2,723 | -2,586 | -5,446 | -5,321 |
Total other expense | -2,650 | -2,582 | -5,335 | -5,312 |
Net loss | -3,061 | -8,432 | -8,772 | -19,625 |
Other comprehensive income (loss): | ' | ' | ' | ' |
Unrealized gain (loss) on investments | 40 | -2 | 90 | -5 |
Comprehensive loss | -3,021 | -8,434 | -8,682 | -19,630 |
Net loss attributable to common stockholders | ($3,061) | ($8,432) | ($8,772) | ($19,625) |
Net loss per share attributable to common stockholders | ($0.02) | ($0.08) | ($0.07) | ($0.19) |
Shares used in computing basic and diluted net loss per share of common stock | 135,873,613 | 104,977,247 | 130,277,157 | 102,325,469 |
Consolidated_Statements_of_Cas
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 | ($8,772) | ($19,625) |
Adjustments to reconcile net loss to net cash used in operating activities: | ' | ' |
Amortization of purchased premium/discount | 271 | 21 |
Depreciation of fixed assets | 422 | 416 |
Non-cash interest expense | 324 | 3,117 |
Compensation expenses associated with stock-based compensation plans | 3,251 | 2,828 |
Non-cash stock issuance | 0 | 1,076 |
Changes in operating assets and liabilities: | ' | ' |
Accounts receivable | 1,263 | 886 |
Other current assets | -224 | 678 |
Inventory | 570 | 1,038 |
Accounts payable and accrued expenses | -1,537 | -1,421 |
Deferred revenue | -683 | -754 |
Long-term deferred rent | -110 | -61 |
Other | 62 | -35 |
Net cash used in operating activities | -5,163 | -11,836 |
Cash flows from investing activities: | ' | ' |
Purchase of investments | -114,573 | 0 |
Proceeds from sales and maturities of investments | 0 | 6,000 |
Purchase of fixed assets | -145 | -345 |
Net cash (used in) provided by investing activities | -114,718 | 5,655 |
Cash flows from financing activities: | ' | ' |
Gross proceeds from common and preferred stock offering | 85,100 | 30,000 |
Fees associated with common and preferred stock offering | -5,392 | -921 |
Repayment of long-term obligations | -233 | -219 |
Proceeds from the issuance of common stock under employee stock purchase plan and exercise of stock options | 2,332 | 1,230 |
Net cash provided by financing activities | 81,807 | 30,090 |
Net (decrease) increase in cash and cash equivalents | -38,074 | 23,909 |
Cash and cash equivalents at beginning of the period | 68,085 | 20,018 |
Cash and cash equivalents at end of the period | 30,011 | 43,927 |
Supplemental disclosure of cash flow information: | ' | ' |
Interest paid | $4,618 | $2,146 |
BUSINESS_OVERVIEW
BUSINESS OVERVIEW | 6 Months Ended | ||
Jun. 30, 2014 | |||
Accounting Policies [Abstract] | ' | ||
BUSINESS OVERVIEW | ' | ||
1. BUSINESS OVERVIEW | |||
Dyax Corp. (“Dyax” or “the Company”) is a biopharmaceutical company focused on: | |||
· | Hereditary Angioedema and Other Plasma-Kallikrein-Mediated Disorders | ||
The Company develops and commercializes treatments for hereditary angioedema (HAE) and is working to identify other disorders that are mediated by plasma kallikrein (PKM disorders). | |||
The Company discovered and developed KALBITOR® (ecallantide), a plasma kallikrein inhibitor, and is selling this product in the United States for the treatment of acute attacks of HAE. Additionally, the Company is developing DX-2930, a fully human monoclonal antibody inhibitor of plasma kallikrein, which is believed to be a candidate to treat HAE prophylactically. The Company has also developed a biomarker assay that detects the activation of plasma kallikrein in patient blood. It intends to use this assay to expedite the development of DX-2930 and to assist in identifying other PKM disorders. | |||
· | Licensing and Funded Research Portfolio (LFRP) | ||
The Company has a portfolio of product candidates being developed by licensees using its phage display technology. This portfolio currently includes one approved product and multiple product candidates in various stages of clinical development, including three in Phase 3 trials, for which the Company is eligible to receive future royalties and/or milestone payments. Recently, CYRAMZATM (ramucirumab) received approval from the U.S. Food and Drug Administration (FDA) as a single-agent treatment for advanced gastric cancer after prior chemotherapy. | |||
SUMMARY_OF_SIGNIFICANT_ACCOUNT
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 6 Months Ended | ||||||||||||||||
Jun. 30, 2014 | |||||||||||||||||
Accounting Policies [Abstract] | ' | ||||||||||||||||
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ' | ||||||||||||||||
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |||||||||||||||||
Basis of Presentation | |||||||||||||||||
The accompanying unaudited interim consolidated financial statements have been prepared by the Company in accordance with accounting principles generally accepted in the United States of America (GAAP) for interim financial information. It is management’s opinion that the accompanying unaudited interim consolidated financial statements reflect all adjustments (which are normal and recurring) necessary for a fair statement of the results for the interim periods. The financial statements should be read in conjunction with the consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2013. The accompanying December 31, 2013 consolidated balance sheet was derived from audited financial statements, but does not include all disclosures required by GAAP. | |||||||||||||||||
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect (i) the reported amounts of assets and liabilities, (ii) disclosure of contingent assets and liabilities at the dates of the financial statements and (iii) the reported amounts of revenue and expenses during the reporting periods. Actual results could differ from those estimates. The results of operations for the three and six months ended June 30, 2014 are not necessarily indicative of the results that may be expected for the year ending December 31, 2014. | |||||||||||||||||
Basis of Consolidation | |||||||||||||||||
The accompanying consolidated financial statements include the accounts of the Company and the Company's European subsidiaries Dyax S.A. and Dyax BV. All inter-company accounts and transactions have been eliminated. | |||||||||||||||||
Use of Estimates | |||||||||||||||||
The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make certain estimates and assumptions that affect the amounts of assets and liabilities reported and disclosure of contingent assets and liabilities at the dates of the financial statements and the reported amounts of revenue and expenses during the reporting periods. The significant estimates and assumptions in these financial statements include revenue recognition for licensing and collaboration agreements, product sales allowances, royalty interest obligations, useful lives with respect to long-lived assets, valuation of stock options, clinical trial accruals and other accrued expenses and tax valuation reserves. Actual results could differ from those estimates. | |||||||||||||||||
Concentration of Credit Risk | |||||||||||||||||
Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash, cash equivalents, short-term investments and trade accounts receivable. At June 30, 2014 and December 31, 2013, approximately 96% and 89%, respectively, of the Company's cash, cash equivalents and short-term investments were invested in money market funds backed by U.S. Treasury obligations, U.S. Treasury notes and bills, and obligations of United States government agencies held by one financial institution. The Company maintains balances in various operating accounts in excess of federally insured limits. | |||||||||||||||||
The Company provides most of its services and licenses its technology to pharmaceutical and biomedical companies worldwide, and makes all product sales to its distributors. Concentrations of credit risk with respect to trade receivable balances associated with the Company’s development and license fee revenue are usually limited on an ongoing basis, due to the diverse number of licensees and collaborators comprising the Company's customer base. Trade receivable balances associated with the Company’s product sales are comprised of only a few customers, due to the limited number of distributors the Company uses in its distribution network. The Company completes ongoing credit evaluations of their customers. As of June 30, 2014, two customers accounted for 41% (US Bio) and 18% (Walgreens) of the accounts receivable balance. As of December 31, 2013, two customers accounted for 35% (US Bio) and 26% (Walgreens) of the accounts receivable balance. | |||||||||||||||||
Cash and Cash Equivalents | |||||||||||||||||
All highly liquid investments purchased with an original maturity of ninety days or less are considered to be cash equivalents. Cash and cash equivalents consist of cash, money market and U.S. Treasury funds. | |||||||||||||||||
Investments | |||||||||||||||||
Short-term investments consist of investments with original maturities greater than ninety days and remaining maturities less than one year at period end. The Company has also classified its investments with maturities beyond one year as short-term, based on their highly liquid nature and as these marketable securities represent the investment of cash that is available for current operations. The Company considers its portfolio of investments as available-for-sale. Accordingly, these investments are recorded at fair value, which is based on quoted market prices. As of June 30, 2014, the Company's investments consisted of U.S. Treasury notes and bills with an amortized cost of $157.6 million, an estimated fair value of $157.7 million, and had an unrealized gain of $93,000, which has been recorded in other comprehensive income. As of December 31, 2013, the Company's investments consisted of United States Treasury notes and bills with an estimated fair value and amortized cost of $43.3 million, and had an unrealized gain of $3,000, which is recorded in other comprehensive income. | |||||||||||||||||
Inventories | |||||||||||||||||
Inventories are stated at the lower of cost or market with cost determined under the first-in, first-out, or FIFO, basis. The Company evaluates inventory levels and would write-down inventory that is expected to expire prior to being sold, inventory that has a cost basis in excess of its expected net realizable value, inventory in excess of expected sales requirements, or inventory that fails to meet commercial sale specifications, through a charge to cost of product sales. Included in the cost of inventory are capitalized employee stock-based compensation costs for those employees dedicated to manufacturing efforts. Inventory on-hand that will be sold beyond the Company's normal operating cycle is classified as non-current and grouped with other assets on the Company's consolidated balance sheet. | |||||||||||||||||
Fixed Assets | |||||||||||||||||
Property and equipment are recorded at cost and depreciated over the estimated useful lives of the related assets using the straight-line method. Laboratory and production equipment, furniture and office equipment are depreciated over a three to seven year period. Leasehold improvements are stated at cost and are amortized over the lesser of the non-cancelable term of the related lease or their estimated useful lives. Leased equipment is amortized over the lesser of the life of the lease or their estimated useful lives. Maintenance and repairs are charged to expense as incurred. When assets are retired or otherwise disposed of, the cost of these assets and related accumulated depreciation and amortization are eliminated from the balance sheet and any resulting gains or losses are included in operations in the period of disposal. | |||||||||||||||||
The Company records all proceeds received from the lessor for tenant improvements under the terms of its operating lease as deferred rent. The amounts are amortized on a straight-line basis over the term of the lease as an offset to rent expense. | |||||||||||||||||
Impairment of Long-Lived Assets | |||||||||||||||||
The Company’s long-lived assets, consisting primarily of fixed assets, are reviewed for impairment whenever events or changes in business circumstances indicate that the carrying amount of assets may not be fully recoverable or that the useful lives of these assets are no longer appropriate. Each impairment test is based on a comparison of the undiscounted cash flow to the recorded value of the asset. If impairment is indicated, the asset is written down to its estimated fair value, which is computed based on a discounted cash flow basis. | |||||||||||||||||
Revenue Recognition | |||||||||||||||||
The Company’s principal sources of revenue are product sales of KALBITOR and license fees, funding for research and development, and milestones and royalties derived from collaboration and license agreements. In all instances, revenue is recognized only when the price is fixed or determinable, persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, collectability of the resulting receivable is reasonably assured and the Company has no further performance obligations. | |||||||||||||||||
Product Sales and Allowances | |||||||||||||||||
Product Sales. Product sales are generated from the sale of KALBITOR to the Company’s customers, primarily wholesale and specialty distributors, and are recorded upon delivery when title and risk of loss have passed to the customer. Product sales are recorded net of applicable reserves for distributors, prompt pay and other discounts, government rebates, patient financial assistance programs, product returns and other applicable allowances. | |||||||||||||||||
Product Sales Allowances. The Company establishes reserves for trade distributor, prompt pay and volume discounts, government rebates, patient financial assistance programs, product returns and other applicable allowances. Reserves established for these discounts and allowances are classified as a reduction of accounts receivable (if the amount is payable to the customer) or a liability (if the amount is payable to a party other than the customer). | |||||||||||||||||
Allowances against receivable balances primarily relate to prompt payment discounts and are recorded at the time of sale, resulting in a reduction in product sales revenue. Accruals related to government rebates, patient financial assistance programs, product returns and other applicable allowances are recognized at the time of sale, resulting in a reduction in product sales revenue and the recording of an increase in accrued expenses. | |||||||||||||||||
The Company maintains service contracts with its distributors. These contracts include services such as inventory maintenance and patient support services. Accounting standards related to consideration given by a vendor to a customer, including a reseller of a vendor’s product, specify that each consideration given by a vendor to a customer is presumed to be a reduction of the selling price. Consideration should be characterized as a cost if the company receives, or will receive, an identifiable benefit in exchange for the consideration, and fair value of the benefit can be reasonably estimated. The Company has established that patient support services are at fair value and represent a separate and identifiable benefit because these services could be provided by separate third-party vendors. Accordingly, these costs are classified as selling, general and administrative expense. | |||||||||||||||||
Inventory maintenance fees are calculated as a percentage of KALBITOR sales price and accordingly, are classified as a reduction in product sales revenue. | |||||||||||||||||
Prompt Payment and Other Discounts. The Company offers a prompt payment discount to its United States distributors. Since the Company expects that these distributors will take advantage of this discount, the Company accrues 100% of the prompt payment discount that is based on the gross amount of each invoice, at the time of sale. This accrual is adjusted quarterly to reflect actual earned discounts. The Company also offers volume discounts to certain distributors which are accrued quarterly based on sales during the period. | |||||||||||||||||
Government Rebates and Chargebacks. The Company estimates reductions to product sales for Medicaid and Veterans' Administration (VA) programs and the Medicare Part D Coverage Gap Program, as well as for certain other qualifying federal and state government programs. The Company estimates the amount of these reductions based on available KALBITOR patient data, actual sales data and rebate claims. These allowances are adjusted each period based on actual experience. | |||||||||||||||||
Medicaid rebate reserves relate to the Company’s estimated obligations to state jurisdictions under the established reimbursement arrangements of each applicable state. Rebate accruals are recorded during the same period in which the related product sales are recognized. Actual rebate amounts are determined at the time of claim by the state, and the Company will generally make cash payments for such amounts after receiving billings from the state. | |||||||||||||||||
VA rebates or chargeback reserves represent the Company’s estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at a price lower than the list price charged to the Company’s distributor. The distributor will charge the Company for the difference between what the distributor pays for the product and the ultimate selling price to the qualified healthcare provider. Rebate accruals are established during the same period in which the related product sales are recognized. Actual chargeback amounts for Public Health Service are determined at the time of resale to the qualified healthcare provider from the distributor, and the Company will generally issue credits for such amounts after receiving notification from the distributor. | |||||||||||||||||
Although allowances and accruals are recorded at the time of product sale, certain rebates are typically paid out, on average, up to six months or longer after the sale. Reserve estimates are evaluated quarterly and if necessary, adjusted to reflect actual results. Any such adjustments will be reflected in the Company’s operating results in the period of the adjustment. | |||||||||||||||||
Product Returns. Allowances for product returns are recorded during the period in which the related product sales are recognized, resulting in a reduction to product revenue. The Company does not provide its distributors with a general right of product return. The Company permits returns if the product is damaged or defective when received by customers or if the product shelf life has expired. The Company estimates product returns based upon actual returns history and data provided by a distributor. | |||||||||||||||||
Patient Financial Assistance. The Company offers a financial assistance program for commercially insured KALBITOR patients in order to defray patients’ out-of-pocket expenses, including co-payments, to aid patients’ access to KALBITOR. The Company estimates its liability for this program based on actual but unpaid reimbursements, as well as, an estimated reserve for product sold to and held by distributors as of period end, based on the Company’s historical redemption rates. | |||||||||||||||||
An analysis of the amount of, and change in, reserves related to sales allowances is summarized as follows: | |||||||||||||||||
(In thousands) | Prompt pay | Patient | Government | Returns | Total | ||||||||||||
and other | financial | rebates and | |||||||||||||||
discounts | assistance | chargebacks | |||||||||||||||
Balance, as of December 31, 2012 | $ | 388 | $ | 165 | $ | 565 | $ | 551 | $ | 1,669 | |||||||
Current provisions relating to sales in current year | 2,565 | 498 | 2,806 | 145 | 6,014 | ||||||||||||
Adjustments relating to prior years | 23 | -38 | -79 | -141 | -235 | ||||||||||||
Payments relating to sales in current year | -2,165 | -378 | -1,380 | — | -3,923 | ||||||||||||
Payments/returns relating to sales in prior years | -327 | -157 | -278 | -232 | -994 | ||||||||||||
Balance, as of December 31, 2013 | 484 | 90 | 1,634 | 323 | 2,531 | ||||||||||||
Current provisions relating to sales in current year | 1,556 | 179 | 1,425 | 89 | 3,249 | ||||||||||||
Adjustments relating to prior years | 6 | 1 | -6 | -18 | -17 | ||||||||||||
Payments relating to sales in current year | -1,370 | -145 | -494 | — | -2,009 | ||||||||||||
Payments/returns relating to sales in prior years | -383 | -16 | -902 | -53 | -1,354 | ||||||||||||
Balance, as of June 30, 2014 | $ | 293 | $ | 109 | $ | 1,657 | $ | 341 | $ | 2,400 | |||||||
Development and License Fee Revenues | |||||||||||||||||
Collaboration Agreements. The Company enters into collaboration agreements with other companies for the research and development of therapeutic and diagnostic products. The terms of the agreements may include non-refundable signing and licensing fees, funding for research and development, payments related to manufacturing services, milestone payments and royalties on any product sales derived from collaborations. These multiple element arrangements are analyzed to determine how the deliverables, which often include license and performance obligations such as research, steering committee and manufacturing services, are separated into units of accounting. | |||||||||||||||||
For agreements entered into prior to 2011, the Company evaluated license arrangements with multiple elements in accordance with Accounting Standards Codification (ASC), 605-25 Revenue Recognition – Multiple-Element Arrangements. Since 2011, the Company has applied the guidance of ASU 2009-13 to evaluate license arrangements with multiple elements. This guidance amended the accounting standards for certain multiple element arrangements to: | |||||||||||||||||
· | Provide updated guidance on whether multiple elements exist, how the elements in an arrangement should be separated and how the arrangement considerations should be allocated to the separate elements; | ||||||||||||||||
· | Require an entity to allocate arrangement consideration to each element based on a selling price hierarchy, also called the relative selling price method, where the selling price for an element is based on vendor-specific objective evidence (VSOE), if available; third-party evidence (TPE), if available and VSOE is not available; or the best estimate of selling price (BESP), if neither VSOE or TPE is available; and | ||||||||||||||||
· | Eliminate the use of the residual method and require an entity to allocate arrangement consideration using the selling price hierarchy. | ||||||||||||||||
The Company evaluates all deliverables within an arrangement to determine whether or not they provide value to the licensee on a stand-alone basis. Based on this evaluation, the deliverables are separated into units of accounting. If VSOE or VOE is not available to determine the fair value of a deliverable, the Company determines the best estimate of selling price associated with the deliverable. The arrangement consideration, including upfront license fees and funding for research and development, is allocated to the separate units based on relative fair value. | |||||||||||||||||
VSOE is based on the price charged when an element is sold separately and represents the actual price charged for that deliverable. When VSOE cannot be established, we attempt to establish the selling price of the elements of a license arrangement based on VOE. VOE is determined based on third party evidence for similar deliverables when sold separately. In circumstances when the Company charges a licensee for pass-through costs paid to external vendors for development services, these costs represent VOE. | |||||||||||||||||
When we are unable to establish the selling price of an element using VSOE or VOE, management determines BESP for that element. The objective of BESP is to determine the price at which we would transact a sale if the element within the license agreement was sold on a stand-alone basis. Our process for establishing BESP involves management’s judgment and considers multiple factors including discounted cash flows, estimated direct expenses and other costs and available data. | |||||||||||||||||
Based on the value allocated to each unit of accounting within an arrangement, upfront fees and other guaranteed payments are allocated to each unit based on relative value. The appropriate revenue recognition method is applied to each unit and revenue is accordingly recognized as each unit is delivered. | |||||||||||||||||
For agreements entered into prior to 2011, revenue related to upfront license fees was spread over the full period of performance under the agreement, unless the license was determined to provide value to the licensee on a stand-alone basis and the fair value of the undelivered performance obligations, typically including research or steering committee services was determinable. | |||||||||||||||||
Steering committee services that were not inconsequential or perfunctory and were determined to be performance obligations were combined with other research services or performance obligations required under an arrangement, if any, to determine the level of effort required in an arrangement and the period over which the Company expected to complete its aggregate performance obligations. | |||||||||||||||||
Whenever the Company determined that an arrangement should be accounted for as a single unit of accounting, it determined the period over which the performance obligations would be completed. Revenue is recognized using either an efforts-based or time-based proportional performance (i.e. straight-line) method. The Company recognizes revenue using an efforts-based proportional performance method when the level of effort required to complete its performance obligations under an arrangement can be reasonably estimated and such performance obligations are provided on a best-efforts basis. Direct labor hours or full-time equivalents are typically used as the measurement of performance. | |||||||||||||||||
If the Company cannot reasonably estimate the level of effort to complete its performance obligations under an arrangement, then revenue under the arrangement is recognized on a straight-line basis over the period the Company is expected to complete its performance obligations. | |||||||||||||||||
Many of the Company's collaboration agreements entitle it to additional payments upon the achievement of performance-based milestones. Milestones that are tied to development or regulatory approval are not considered probable of being achieved until such approval is received. All milestones which are determined to be substantive milestones are recognized as revenue in the period in which they are met in accordance with Accounting Standards Update (ASU) No. 2010-17, Revenue Recognition – Milestone Method. Milestones tied to counter-party performance are not included in the Company’s revenue model until performance conditions are met. Milestones determined to be non-substantive are allocated to each unit of accounting within an arrangement when met. The allocation of the milestone to each unit is based on relative value and revenue related to each unit is recognized accordingly. | |||||||||||||||||
Costs of revenues related to licensees’ product development, including license fees and development and regulatory milestones are classified as research and development in the consolidated statements of operations and comprehensive loss. | |||||||||||||||||
Phage Display Library Licenses. Standard terms of the proprietary phage display library agreements generally include non-refundable signing fees, license maintenance fees, development milestone payments, product license payments and royalties on product sales. Signing fees and maintenance fees are generally recognized on a straight line basis over the term of the agreement as deliverables within these arrangements are determined to not provide the licensee with value on a stand-alone basis and therefore are accounted for as a single unit of accounting. As milestones are achieved under a phage display library license, a portion of the milestone payment, equal to the percentage of the performance period completed when the milestone is achieved, multiplied by the amount of the milestone payment, will be recognized. The remaining portion of the milestone will be recognized over the remaining performance period on a straight-line basis. If the Company has no future obligations under the license, milestone payments under these license arrangements are recognized as revenue when the milestone is achieved. Product license payments, which are optional to the licensee, are substantive and therefore are excluded from the initial allocation of the arrangement consideration. These payments are recognized as revenue when the license is issued upon exercise of the licensee’s option, if the Company has no future obligations under the agreement. If there are future obligations under the agreement, product license payments are recognized as revenue only to the extent of the fair value of the license. Amounts paid in excess of fair value are recognized in a manner similar to milestone payments. Payments received that have not met the appropriate criteria for revenue recognition are recorded as deferred revenue. | |||||||||||||||||
Phage Display Patent Licenses. The Company previously licensed its phage display patents on a non-exclusive basis to third parties for use in connection with the research and development of therapeutic, diagnostic, and other products. The core patents in this portfolio expired in November 2012. Even after patent expiration, the Company generally remains eligible under these patent licenses to receive milestones and/or royalties for products discovered prior to patent expiration, although certain existing patent licenses will no longer have a royalty obligation. The Company does not expect the expiration of these patents to have a material impact on the LFRP. | |||||||||||||||||
Standard terms of the patent rights agreements include non-refundable signing fees, non-refundable license maintenance fees, development milestone payments and/or royalties on product sales. Signing fees and maintenance fees are generally recognized on a straight line basis over the term of the agreement or through the date of patent expiry, if shorter, except that in the case of perpetual patent licenses for which fees were recognized immediately if it was determined that the Company had no future obligations under the agreement and the payments were made upfront. If the Company has no remaining performance obligations under the patent license agreement, milestones are recognized as revenue in the period in which the milestone is achieved. | |||||||||||||||||
LFRP Milestones | |||||||||||||||||
Non-substantive Milestones. Under the LFRP licenses, the Company is eligible to receive clinical development, regulatory filing and marketing approval milestones, which vary from licensee to licensee. Achievement of these milestones is contingent upon each licensee’s efforts and involves risks and uncertainty related to drug development, regulatory approval and intellectual property that could lead to milestones never being met. | |||||||||||||||||
Based on information available to the Company regarding pre-clinical and clinical candidates in the LFRP, developed using its technology and through intellectual property rights granted, it is estimated that the Company could receive up to $81 million in development milestones, $68 million in regulatory filing milestones and $96 million in marketing approval milestones. As achievement of these milestones is outside the control of the Company and is contingent upon the licensees’ efforts, they have been determined to be non-substantive milestones. | |||||||||||||||||
The Company recognized revenue of approximately $2.1 million related to milestones from the LFRP for each of the three and six months ended June 30, 2014 and approximately $75,000 and $1.3 million for the three and six months ended June 30, 2013, respectively. | |||||||||||||||||
Substantive Milestones. Under certain collaboration agreements, the Company performs funded research for various collaborators using its phage display technology and libraries. These arrangements typically include technical milestones that are based on agreed upon objectives to be met under the research campaign, which are considered to be commensurate with the Company’s performance and therefore have been determined to be substantive milestones. | |||||||||||||||||
There was no amount recognized for technical milestones during the three and six months ended June 30, 2014 and 2013. The Company is not eligible to receive any future technical milestones at this time. | |||||||||||||||||
Non-LFRP Milestones | |||||||||||||||||
In certain countries outside of the U.S., the Company has entered into licensing agreements for the development and commercialization of KALBITOR for the treatment of HAE and other angioedema indications. Under these agreements, the Company is eligible to receive certain development and sales milestones. See Note 3, Significant Transactions. | |||||||||||||||||
Royalty Revenues | |||||||||||||||||
Royalty revenue is recognized when it becomes determinable and collectability is reasonably assured; otherwise the Company recognizes royalty revenue upon receipt of payment. | |||||||||||||||||
Cost of Product Sales | |||||||||||||||||
Cost of product sales includes costs to procure, manufacture and distribute KALBITOR and manufacturing royalties. Costs associated with the manufacture of KALBITOR prior to regulatory approval in the United States were expensed when incurred as a research and development cost and accordingly, KALBITOR units sold during the three and six months ended June 30, 2013 do not include the full cost of drug manufacturing. For the three and six months ended June 30, 2014, KALBITOR units sold included the full cost of drug manufacturing. | |||||||||||||||||
Research and Development | |||||||||||||||||
Research and development costs include all direct costs, including salaries and benefits for research and development personnel, outside consultants, costs of clinical trials, sponsored research, clinical trials insurance, other outside costs, depreciation and facility costs related to the development of drug candidates, as well as certain pass-through costs under the Company’s cross license agreements related to product development by its LFRP licensees, including license fees and development and regulatory milestones. | |||||||||||||||||
Income Taxes | |||||||||||||||||
The Company utilizes the asset and liability method of accounting for income taxes in accordance with ASC 740. Under this method, deferred tax assets and liabilities are recognized for the expected future tax consequences of temporary differences between the carrying amounts and the tax basis of assets and liabilities using the enacted statutory tax rates. At June 30, 2014 and December 31, 2013, there were no unrecognized tax benefits. | |||||||||||||||||
The Company accounts for uncertain tax positions using a "more-likely-than-not" threshold for recognizing and resolving uncertain tax positions. The evaluation of uncertain tax positions is based on factors that include, but are not limited to, changes in tax law, the measurement of tax positions taken or expected to be taken in tax returns, the effective settlement of matters subject to audit, new audit activity and changes in facts or circumstances related to a tax position. The Company evaluates uncertain tax positions on a quarterly basis and adjusts the level of the liability to reflect any subsequent changes in the relevant facts surrounding the uncertain positions. | |||||||||||||||||
Translation of Foreign Currencies | |||||||||||||||||
Assets and liabilities of the Company's foreign subsidiaries are translated at period end exchange rates. Amounts included in the statements of operations are translated at the average exchange rate for the period. All currency translation adjustments are recorded to other income (expense) in the consolidated statement of operations and comprehensive loss. The Company recorded income of $3,000 for each of the three and six months ended June 30, 2014 for the translation of foreign currency. For the three and six months ending June 30, 2013 the Company recorded other income of $6,000 and other expense of $2,000, respectively, for the translation of foreign currency. | |||||||||||||||||
Share-Based Compensation | |||||||||||||||||
The Company’s share-based compensation program consists of share-based awards granted to employees in the form of stock options and restricted stock units (RSUs), as well as its 1998 Employee Stock Purchase Plan, as amended (the Purchase Plan). The Company’s share-based compensation expense is recorded in accordance with ASC 718. | |||||||||||||||||
Income or Loss Per Share | |||||||||||||||||
The Company follows the two-class method when computing net loss per share, as it had issued shares that met the definition of participating securities. The two-class method determines net loss per share for each class of common and participating securities according to dividends declared or accumulated and participation rights in undistributed earnings. The two-class method requires income available to common stockholders for the period to be allocated between common and participating securities based upon their respective rights to receive dividends, as if all income for the period had been distributed. | |||||||||||||||||
The Company presents two earnings or loss per share (EPS) amounts, basic and diluted in accordance with ASC 260. Basic earnings or loss per share is computed using the weighted average number of shares of common stock outstanding. Diluted net loss per share does not differ from basic net loss per share since potential common shares from the exercise of stock options, warrants or rights under the Purchase Plan are anti-dilutive for the three and six months ended June 30, 2014 and 2013, and therefore, are excluded from the calculation of diluted net loss per share. | |||||||||||||||||
The weighted average of stock options outstanding totaled 12,181,512 as of June 30, 2014, and the weighted average of stock options and warrants outstanding totaled 14,053,495 as of June 30, 2013. | |||||||||||||||||
Comprehensive Income (Loss) | |||||||||||||||||
The Company accounts for comprehensive income (loss) under ASC 220, Comprehensive Income, which established standards for reporting and displaying comprehensive income (loss) and its components in a full set of general purpose financial statements. The statement required that all components of comprehensive income (loss) be reported in a financial statement that is displayed with the same prominence as other financial statements. The Company is presenting comprehensive income (loss) as part of the consolidated statements of operations and comprehensive loss. | |||||||||||||||||
Business Segments | |||||||||||||||||
The Company discloses business segments under ASC 280, Segment Reporting. The statement established standards for reporting information about operating segments and disclosures about products and services, geographic areas and major customers. The Company operates as one business segment within predominantly one geographic area. | |||||||||||||||||
New Accounting Pronouncements | |||||||||||||||||
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (FASB) or other standard setting bodies, which are adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption. | |||||||||||||||||
In May 2014, the FASB issued an amendment which will replace most of the existing revenue recognition guidance within U.S. GAAP. The core principle of this guidance is that an entity should recognize revenue for the transfer of goods or services to customers in an amount that it expects to be entitled to receive for those goods or services. In doing so, companies will be required to make certain judgments and estimates, including identifying contract performance obligations, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price among separate performance obligations. Additionally, the amendment requires disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, significant judgments reached in the application of the guidance and assets recognized from the costs to obtain or fulfill a contract. Effective for the Company beginning on January 1, 2017, the amendment allows for two methods of adoption, a full retrospective method or a modified retrospective approach with the cumulative effect recognized at the date of initial application. Early adoption is not permitted. The Company is in the process of determining the method of adoption and the impact of this amendment on its consolidated financial statements. | |||||||||||||||||
SIGNIFICANT_TRANSACTIONS
SIGNIFICANT TRANSACTIONS | 6 Months Ended |
Jun. 30, 2014 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | ' |
SIGNIFICANT TRANSACTIONS | ' |
3. SIGNIFICANT TRANSACTIONS | |
CVie | |
In 2013, the Company entered into an agreement with CVie Therapeutics (CVie), a subsidiary of Lee’s Pharmaceutical Holdings Ltd., to develop and commercialize KALBITOR for the treatment of HAE and other angioedema indications in China, Hong Kong and Macau. Under the terms of this exclusive license agreement, Dyax received a $1.0 million upfront payment and is eligible to receive up to $11 million in future regulatory and sales milestones. Additionally, the Company is eligible to receive royalties on net product sales. CVie is solely responsible for all costs associated with development, regulatory activities and the commercialization of KALBITOR in its licensed territories. CVie will purchase drug product from the Company on a cost-plus basis for its commercial supply when and if KALBITOR is approved for commercial sale in the CVie territories. | |
The Company analyzed this multiple element arrangement in accordance with ASC 605 and evaluated whether the performance obligations under this agreement, including the product license, steering committee, and manufacturing services should be accounted for as a single unit or multiple units of accounting. Because of the risk associated with obtaining approval for commercial sale in the CVie territories, manufacturing services associated with commercial supply are considered a contingent deliverable and will be accounted for if and when performed. As CVie is required to obtain all drug product for both clinical development and commercial demand from the Company, all other deliverables under this arrangement were determined to provide no stand-alone value to the licensee. Accordingly, it was determined that the license, manufacturing services associated with clinical supply, and steering committee performance obligations under this agreement represent a single unit of accounting. | |
At this time, the Company cannot reasonably estimate the level of effort required to fulfill its obligations and, therefore, is recognizing revenue on a straight-line basis over the estimated development period in the CVie territories, which was extended through 2019. | |
The Company recognized revenue of $33,000 for each of the three and six months ended June 30, 2014 under this arrangement. For each of the three and six months ended June 30, 2013 the Company recognized revenue of $78,000. As of June 30, 2014, the Company has deferred $795,000 of revenue related to this arrangement, which is recorded in deferred revenue on the accompanying consolidated balance sheets. | |
Novellus | |
In 2013, the Company entered into an agreement with Novellus Biopharma AG (Novellus) to develop and commercialize KALBITOR for the treatment of HAE and other angioedema indications in select countries in Latin America, including Argentina, Brazil, Chile, Colombia, Mexico and Venezuela. Under the terms of the exclusive license agreement, the Company was entitled to receive payments totaling $800,000 in 2013, of which $500,000 was received through year-end. Additionally, the Company is eligible to receive up to $5.2 million in future regulatory and sales milestones and royalties on net product sales. Novellus is solely responsible for all costs associated with development, regulatory activities, and the commercialization of KALBITOR in their licensed territories. Novellus will purchase drug product from the Company on a cost-plus basis for its commercial supply. | |
The Company analyzed this multiple element arrangement in accordance with ASC 605 and evaluated whether the performance obligations under this agreement, including the product license, steering committee, and manufacturing services should be accounted for as a single unit or multiple units of accounting. As Novellus is required to obtain all drug product for both clinical and commercial demand from the Company, all other deliverables under this arrangement were determined to provide no stand-alone value to the licensee. Accordingly, it was determined that performance obligations under this agreement represent a single unit of accounting. | |
The Company will recognize revenue related to this arrangement, including the upfront payments, on a unit output basis, as products under clinical and commercial supply are provided to Novellus. As no supply has been provided to Novellus to date, no revenue has been recognized for the three and six months ended June 30, 2014, and the Company has deferred $800,000 of revenue related to this arrangement, which is recorded in deferred revenue on the accompanying consolidated balance sheets. | |
CMIC | |
In 2010, the Company entered into an agreement with CMIC Co., Ltd. (CMIC) to develop and commercialize subcutaneous ecallantide for the treatment of HAE and other angioedema indications in Japan. Under the terms of the agreement, the Company received a $4.0 million upfront payment and was eligible to receive development and sales milestones for ecallantide in HAE and other angioedema indications and royalties on net product sales. CMIC was solely responsible for all costs associated with development, regulatory activities, and commercialization of ecallantide for all angioedema indications in Japan. | |
CMIC provided the Company written notice of CMIC’s intent to terminate the agreement, effective in June 2014, at which time all of the rights to develop ecallantide in Japan returned to the Company. The Company has no obligations to CMIC in connection with, or following the termination. | |
Upon the commencement of the agreement in 2010, the Company analyzed this multiple element arrangement in accordance with ASC 605 and evaluated whether the performance obligations under this agreement, including the product license, development of ecallantide for the treatment of HAE and other angioedema indications in Japan, steering committee, and manufacturing services should be accounted for as a single unit or multiple units of accounting. The Company determined that there were two units of accounting. The first unit of accounting included the product license, the committed future development services and the steering committee involvement. The second unit of accounting relates to the manufacturing services. As the scope and timing of the future development of ecallantide for the treatment of HAE and other indications in the CMIC territory are the joint responsibility of the Company and CMIC, the Company could not reasonably estimate the level of effort required to fulfill its obligations under the first unit of accounting, and, as a result, the Company was recognizing revenue under the first unit of accounting on a straight-line basis over the estimated development period of ecallantide for the treatment of HAE in the CMIC territory. Upon receiving notification of CMIC’s irrevocable intent to terminate, it was determined the Company had no further obligations under this arrangement, and therefore, the full amount of deferred revenue of $2.0 million was recognized in the quarter ending December 31, 2013. | |
No revenue was recorded for the three and six months ended June 30, 2014 and there will be no further revenue recorded under this agreement. The Company recognized revenue of approximately $206,000 and $397,000 related to this agreement for the three and six months ended June 30, 2013, respectively. | |
Sigma Tau | |
The Company entered into a collaboration agreement and several amendments thereto with Sigma-Tau Rare Diseases S.A. (as successor-in-interest to Defiante Farmaceutica S.A.) (Sigma Tau) to develop and commercialize subcutaneous ecallantide for the treatment of HAE and other therapeutic indications in various territories throughout the world. | |
In March 2013, Sigma Tau’s rights to remaining territories were eliminated under a termination agreement between the Company and Sigma Tau. The principal terms of the termination agreement included provision for (i) the revocation of all licenses granted by the Company to Sigma Tau, (ii) the termination of all other obligations under the license agreement, (iii) the issuance of 271,665 shares of the Company’s common stock to Sigma Tau, and (iv) the right of Sigma Tau to receive $500,000 for every $5.0 million of compensation received by the Company during the next ten years in relation to the potential license or supply of ecallantide exclusively in those territories that had been previously licensed to Sigma Tau. During the three months ended March 31, 2013, in accordance with ASC 605-50, the $1.1 million determined to be the fair value of the common stock as of the date of issuance was recorded as a reduction to development and license fee revenue on the statement of operations and $85,000 of deferred revenue attributable to the JSC services was recognized as revenue. No additional revenue is expected to be recognized in future periods. | |
FAIR_VALUE_MEASUREMENTS
FAIR VALUE MEASUREMENTS | 6 Months Ended | |||||||||||||
Jun. 30, 2014 | ||||||||||||||
Fair Value Disclosures [Abstract] | ' | |||||||||||||
FAIR VALUE MEASUREMENTS | ' | |||||||||||||
4. FAIR VALUE MEASUREMENTS | ||||||||||||||
The following tables present information about the Company's financial assets that have been measured at fair value as of June 30, 2014 and December 31, 2013 and indicate the fair value hierarchy of the valuation inputs utilized to determine such fair value. In general, fair values determined by Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities. Fair values determined by Level 2 inputs utilize observable inputs other than Level 1 prices, 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 related assets or liabilities. Fair values determined by Level 3 inputs utilize unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. | ||||||||||||||
Description (in thousands) | June 30, | Quoted | Significant | Significant | ||||||||||
2014 | Prices in | Other | Unobservable | |||||||||||
Active | Observable | Inputs | ||||||||||||
Markets | Inputs | (Level 3) | ||||||||||||
(Level 1) | (Level 2) | |||||||||||||
Assets: | ||||||||||||||
Money Market Funds | $ | 23,159 | $ | 23,159 | $ | — | $ | — | ||||||
Marketable debt securities | 157,688 | — | 157,688 | — | ||||||||||
Total | $ | 180,847 | $ | 23,159 | $ | 157,688 | $ | — | ||||||
Description (in thousands) | December 31, | Quoted | Significant | Significant | ||||||||||
2013 | Prices in | Other | Unobservable | |||||||||||
Active | Observable | Inputs | ||||||||||||
Markets | Inputs | (Level 3) | ||||||||||||
(Level 1) | (Level 2) | |||||||||||||
Assets: | ||||||||||||||
Money Market Funds | $ | 55,569 | $ | 55,569 | $ | — | $ | — | ||||||
Marketable debt securities | 43,296 | — | 43,296 | — | ||||||||||
Total | $ | 98,865 | $ | 55,569 | $ | 43,296 | $ | — | ||||||
The following tables summarize the Company’s marketable securities at June 30, 2014 and December 31, 2013: | ||||||||||||||
June 30, 2014 | ||||||||||||||
Description (in thousands) | Amortized | Gross | Gross | Fair Value | ||||||||||
Cost | Unrealized | Unrealized | ||||||||||||
Gains | Losses | |||||||||||||
US Treasury Bills and Notes (due within 1 year) | $ | 72,262 | $ | 53 | $ | — | $ | 72,315 | ||||||
US Treasury Bills and Notes | 85,333 | 40 | — | 85,373 | ||||||||||
(due after 1 year through 2 years) | ||||||||||||||
Total | $ | 157,595 | $ | 93 | $ | — | $ | 157,688 | ||||||
December 31, 2013 | ||||||||||||||
Description (in thousands) | Amortized | Gross | Gross | Fair Value | ||||||||||
Cost | Unrealized | Unrealized | ||||||||||||
Gains | Losses | |||||||||||||
US Treasury Bills and Notes (due within 1 year) | $ | 2,001 | $ | 1 | $ | — | $ | 2,002 | ||||||
US Treasury Bills and Notes | 41,292 | 2 | — | 41,294 | ||||||||||
(due after 1 year through 2 years) | ||||||||||||||
Total | $ | 43,293 | $ | 3 | $ | — | $ | 43,296 | ||||||
As of June 30, 2014 and December 31, 2013, the Company's cash equivalents and short-term investments have been initially valued at the transaction price and subsequently valued utilizing a third party pricing service. We validate the prices provided by our third party pricing service by understanding the models used and obtaining market values from other pricing sources. | ||||||||||||||
The carrying amounts reflected in the consolidated balance sheets for cash, cash equivalents, other current assets, accounts payable and accrued expenses and other current liabilities approximate fair value due to their short-term maturities. | ||||||||||||||
INVENTORY
INVENTORY | 6 Months Ended | |||||||
Jun. 30, 2014 | ||||||||
Inventory Disclosure [Abstract] | ' | |||||||
INVENTORY | ' | |||||||
5. INVENTORY | ||||||||
Costs associated with the manufacture of KALBITOR are recorded as inventory. | ||||||||
Inventory that will be sold beyond the Company's normal operating cycle is classified as non-current and grouped with Other Assets on the Company's balance sheet. As of June 30, 2014 and December 31, 2013, approximately $4.6 million and $5.5 million of inventory, respectively, is classified as non-current. | ||||||||
Inventory consists of the following: | ||||||||
June 30, | December 31, | |||||||
2014 | 2013 | |||||||
(in thousands) | ||||||||
Raw Materials | $ | 1,116 | $ | 1,116 | ||||
Work in Progress | 5,277 | 5,965 | ||||||
Finished Goods | 1,422 | 1,281 | ||||||
Total | $ | 7,815 | $ | 8,362 | ||||
FIXED_ASSETS
FIXED ASSETS | 6 Months Ended | |||||||
Jun. 30, 2014 | ||||||||
Property Plant And Equipment [Abstract] | ' | |||||||
FIXED ASSETS | ' | |||||||
6. FIXED ASSETS | ||||||||
Fixed assets consist of the following: | ||||||||
June 30, | December 31, | |||||||
2014 | 2013 | |||||||
(in thousands) | ||||||||
Laboratory equipment | $ | 3,932 | $ | 3,932 | ||||
Furniture and office equipment | 849 | 815 | ||||||
Software and computers | 2,968 | 2,958 | ||||||
Leasehold improvements | 4,554 | 4,510 | ||||||
Total | 12,303 | 12,215 | ||||||
Less: accumulated depreciation | -7,626 | -7,255 | ||||||
$ | 4,677 | $ | 4,960 | |||||
Depreciation expense for the three and six months ended June 30, 2014 was approximately $211,000 and $422,000, respectively and $204,000 and $416,000 for the three and six months ended June 30, 2013, respectively. | ||||||||
ACCOUNTS_PAYABLE_AND_ACCRUED_E
ACCOUNTS PAYABLE AND ACCRUED EXPENSES | 6 Months Ended | |||||||
Jun. 30, 2014 | ||||||||
Payables And Accruals [Abstract] | ' | |||||||
ACCOUNTS PAYABLE AND ACCRUED EXPENSES | ' | |||||||
7. ACCOUNTS PAYABLE AND ACCRUED EXPENSES | ||||||||
Accounts payable and accrued expenses consist of the following: | ||||||||
June 30, | December 31, | |||||||
2014 | 2013 | |||||||
(in thousands) | ||||||||
Accounts payable | $ | 1,096 | $ | 1,407 | ||||
Accrued employee compensation and related taxes. | 3,921 | 4,609 | ||||||
Accrued external research and development and sales expenses | 1,498 | 1,778 | ||||||
Accrued legal | 664 | 456 | ||||||
Accrued sales allowances | 1,948 | 1,918 | ||||||
Other accrued liabilities | 1,342 | 2,374 | ||||||
Total | $ | 10,469 | $ | 12,542 | ||||
LONGTERM_OBLIGATIONS
LONG-TERM OBLIGATIONS | 6 Months Ended | |||||||
Jun. 30, 2014 | ||||||||
Debt Disclosure [Abstract] | ' | |||||||
LONG-TERM OBLIGATIONS | ' | |||||||
8. LONG-TERM OBLIGATIONS | ||||||||
Notes Payable - HealthCare Royalty Partners | ||||||||
In 2012, the Company completed the second closing under an agreement with an affiliate of HealthCare Royalty Partners (HC Royalty), which the Company entered into in December 2011 to refinance its existing loans from HC Royalty. At June 30, 2014, the aggregate principal amount of the loan was $84.5 million, consisting of a $22.8 million Tranche A Loan and a $61.7 million Tranche B Loan (collectively, the “Loan”). The Loan bears interest at a rate of 12% per annum, payable quarterly. The Loan will mature in August 2018, and can be repaid without penalty beginning in August 2015. | ||||||||
In connection with the Loan, the Company entered into a security agreement granting HC Royalty a security interest in the intellectual property related to the LFRP, and the revenues generated by the Company through the licenses of the intellectual property related to the LFRP. The security agreement does not apply to KALBITOR, DX-2930 or any of the Company’s other internal drug development programs. | ||||||||
Under the terms of the agreement, the Company is required to repay the Loan based on the annual net LFRP receipts. Until September 30, 2016, required payments are equal to the sum of 75% of the first $15.0 million in specified annual LFRP receipts and 25% of specified annual LFRP receipts over $15.0 million. After September 30, 2016, and until the maturity date or the complete repayment of the Loan, HC Royalty will receive 90% of all included LFRP receipts. If the HC Royalty portion of LFRP receipts for any quarter exceeds the interest for that quarter, then the principal balance will be reduced. Any unpaid principal will be due upon the maturity of the Loan. If the HC Royalty portion of LFRP revenues for any quarterly period is insufficient to cover the cash interest due for that period, the deficiency may be added to the outstanding principal or paid in cash by the Company. After five years from the dates of the Tranche A Loan and the Tranche B Loan, respectively, the Company must repay to HC Royalty all additional accumulated principal above the original loan amounts of $21.7 million and $58.8 million, respectively. | ||||||||
Tranche A Loan | ||||||||
Under the terms of the agreement, the Company received a loan of $20 million (Tranche A Loan) in 2011 and a commitment to refinance the amounts outstanding under the Company’s March 2009 amended and restated loan agreement (the March 2009 Loan) at a reduced interest rate in August 2012. The Tranche A Loan was unsecured and accrued interest at an annual rate of 13% through August 2012. | ||||||||
Upon execution of the Tranche A Loan, the terms of the original loans were determined to be modified under ASC 470. During the three and six months ended June 30, 2014, interest expense on the Loan is being recorded in the Company’s financial statements at an effective interest rate of 12.5%. | ||||||||
Upon modification of the original loans, the note payable balance related to the Tranche A Loan was reduced by $193,000 to reflect payment of the lender’s legal fees in conjunction with the Tranche A Loan; these fees are being accreted over the life of the Loan, through August 2018. | ||||||||
Tranche B Loan | ||||||||
In 2012, the Company completed a second closing with an affiliate of HC Royalty to refinance approximately $57.6 million outstanding under the March 2009 Loan under the same terms as the Tranche A Loan (Tranche B Loan). | ||||||||
Activity under the Loan, adjusted for discounts associated with the debt issuance, including warrants and fees, is presented for financial reporting purposes for the six months ended June 30, 2014 and for the year ended December 31, 2013, as follows: | ||||||||
June 30, 2014 | December 31, 2013 | |||||||
(in thousands) | ||||||||
Beginning balance | $ | 81,516 | $ | 78,061 | ||||
Accretion of discount | 99 | 198 | ||||||
Loan activity: | ||||||||
Interest Expense | 5,292 | 10,447 | ||||||
Payments applied to principal | — | — | ||||||
Payments applied to interest | -2,726 | -5,378 | ||||||
Accrued interest payable | -2,342 | -1,812 | ||||||
Ending balance | $ | 81,839 | $ | 81,516 | ||||
The estimated fair value of the note payable was $83.3 million at June 30, 2014, which was calculated based on level 3 inputs due to the limited availability of comparable data points. The note payable was valued using expected cash flows discounted at our estimate of the currently available market interest rate. | ||||||||
Equipment Loan | ||||||||
In 2012, the Company entered into an equipment lease line of credit for up to $3 million with Silicon Valley Bank. When drawn, the note bears interest at a 6% annual rate. The Company drew down $1.4 million from this line during 2012, which is being financed over a 3-year term. The outstanding balance of this loan was $698,000 and $931,000 as of June 30, 2014 and December 31, 2013, respectively. | ||||||||
Facility Lease | ||||||||
In 2012, the Company relocated its operations to a new facility in Burlington, Massachusetts. The new premises, consisting of approximately 45,000 rentable square feet of office and laboratory facilities, serve as the Company’s principal offices and corporate headquarters. The term of the Burlington lease is ten years, and the Company has rights to extend the term for an additional five years at fair market value subject to specified terms and conditions. The aggregate minimum lease commitment over the ten year term of the new lease is approximately $15.0 million. The Company has provided the landlord a Letter of Credit of $1.1 million to secure its obligations under the lease for which the Company has restricted cash recorded in the accompanying consolidated balance sheet. Under the terms of the Burlington lease agreement, the landlord has provided the Company with a tenant improvement allowance of $2.6 million which was used towards the cost of leasehold improvements. The Company has capitalized approximately $4.5 million in leasehold improvements associated with the Burlington facility. Costs reimbursed under the tenant improvement allowance have been recorded as deferred rent and are being amortized as a reduction to rent expense over the lease term. | ||||||||
STOCKHOLDERS_EQUITY_AND_STOCKB
STOCKHOLDER'S EQUITY AND STOCK-BASED COMPENSATION | 6 Months Ended | |||||||||||||
Jun. 30, 2014 | ||||||||||||||
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ' | |||||||||||||
STOCKHOLDER'S EQUITY AND STOCK-BASED COMPENSATION | ' | |||||||||||||
9. STOCKHOLDER’S EQUITY AND Stock-Based Compensation | ||||||||||||||
Issuance of Common Stock | ||||||||||||||
In March 2014, the Company issued 9,200,000 shares of common stock at $9.25 per share in an underwritten public offering. Net proceeds from the offering were approximately $79.7 million, after deducting offering expenses. | ||||||||||||||
In February 2014, the sole holder of 41,418 shares of preferred stock outstanding elected to convert this preferred stock into 4,141,800 shares of common stock. The Company has no remaining preferred stock outstanding. | ||||||||||||||
Equity Incentive Plan | ||||||||||||||
The Company's 1995 Equity Incentive Plan (the Equity Plan), as amended, is an equity plan under which equity awards, including awards of restricted stock, RSUs and incentive and nonqualified stock options to purchase shares of common stock may be granted to employees, consultants and directors of the Company by action of the Compensation Committee of the Board of Directors. Options are granted at the current fair market value on the date of grant, generally vest ratably over a 48-month period, and expire within ten years from date of grant. RSUs are valued at the current fair market value on the date of grant, and generally vest annually in equal installments over a four-year period. The Equity Plan is intended to attract and retain employees and to provide an incentive for employees, consultants and directors to assist the Company to achieve long-range performance goals and to enable them to participate in the long-term growth of the Company. | ||||||||||||||
In February 2014, the Company’s Board of Directors amended the Equity Plan to increase the number of shares of common stock approved for issuance under the plan and this amendment was approved by the Company’s stockholders in May 2014. At June 30, 2014, a total of 10,455,238 shares were available for future grants under the Equity Plan. | ||||||||||||||
The following table summarizes stock option activity for the period ended June 30, 2014: | ||||||||||||||
Number of | Number of | |||||||||||||
Options | RSUs | |||||||||||||
Outstanding as of December 31, 2013 | 10,628,879 | 253,124 | ||||||||||||
Granted/Awarded | 2,695,159 | 352,841 | ||||||||||||
Options Exercised/Shares Issued | -855,584 | -101,877 | ||||||||||||
Cancelled | -366,076 | -22,276 | ||||||||||||
Outstanding as of June 30, 2014 | 12,102,378 | 481,812 | ||||||||||||
Exercisable as of June 30, 2014 | 6,539,703 | — | ||||||||||||
Employee Stock Purchase Plan | ||||||||||||||
The Company's 1998 Employee Stock Purchase Plan (the Purchase Plan) allows employees to purchase shares of the Company's common stock at a discount from fair market value. Under the Purchase Plan, eligible employees may purchase shares during six-month offering periods commencing on June 1 and December 1 of each year at a price per share of 85% of the lower of the fair market value price per share on the first or last day of each six-month offering period. Participating employees may elect to have up to 10% of their base pay withheld and applied toward the purchase of such shares, subject to the limitation of 875 shares per participant per quarter. The rights of participating employees under the Purchase Plan terminate upon voluntary withdrawal from the Purchase Plan at any time or upon termination of employment. The compensation expense recognized in connection with the Plan was approximately $17,000 and $86,000 for the three and six months ended June 30, 2014, respectively, and approximately $5,000 and $51,000 for the three and six months ended June 30, 2013, respectively. There were 29,051 and 45,001 shares purchased under the Plan during the six months ended June 30, 2014 and 2013, respectively. | ||||||||||||||
In February 2014, the Company’s Board of Directors amended the Purchase Plan to increase the number of shares of common stock approved for issuance under the plan and this amendment was approved by the Company’s stockholders in May 2014. At June 30, 2014, a total of 738,909 shares were reserved and available for issuance under this Plan. | ||||||||||||||
Stock-Based Compensation Expense | ||||||||||||||
The Company measures compensation cost for all stock awards at fair value on date of grant and recognition of compensation over the service period for awards expected to vest. The fair value of stock options was determined using the Black-Scholes valuation model. Such value is recognized as expense over the service period, net of estimated forfeitures and adjusted for actual forfeitures. The estimation of stock awards that will ultimately vest requires significant judgment. The Company considers many factors when estimating expected forfeitures, including historical experience. Actual results and future changes in estimates may differ substantially from the Company's current estimates. | ||||||||||||||
The following table reflects stock compensation expense recorded, net of amounts capitalized into inventory: | ||||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||
June 30, | June 30, | |||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||
(in thousands) | ||||||||||||||
Compensation expense related to: | ||||||||||||||
Equity Incentive Plan | $ | 1,994 | $ | 879 | $ | 3,165 | $ | 2,777 | ||||||
Employee Stock Purchase Plan | 17 | 5 | 86 | 51 | ||||||||||
$ | 2,011 | $ | 884 | $ | 3,251 | 2,828 | ||||||||
Stock-based compensation expense charged to: | ||||||||||||||
Research and development | $ | 737 | $ | 280 | $ | 1,227 | $ | 508 | ||||||
Selling, general and administrative | $ | 1,274 | $ | 604 | $ | 2,024 | $ | 2,320 | ||||||
Stock-based compensation expense of $19,000 and $23,000 which has been excluded from the chart above, was capitalized into inventory for the three and six months ended June 30, 2014, respectively, and $3,000 and $7,000 for the three and six months ended June 30, 2013, respectively. Capitalized stock-based compensation is recognized into cost of product sales when the related product is sold. | ||||||||||||||
Stock-based compensation expense for the six months ending June 30, 2013 included $1.1 million related to the modification of certain stock options held by to a former executive who ceased employment in March 2013. | ||||||||||||||
INCOME_TAXES
INCOME TAXES | 6 Months Ended |
Jun. 30, 2014 | |
Income Tax Disclosure [Abstract] | ' |
INCOME TAXES | ' |
10. INCOME TAXES | |
Deferred tax assets and deferred tax liabilities are recognized based on temporary differences between the financial reporting and tax basis of assets and liabilities using future enacted rates. A valuation allowance is recorded against deferred tax assets for which the Company determines that it does not meet the criteria under ASC 740. | |
Included in the Company’s net operating loss (NOL) deferred tax asset at December 31, 2013 are approximately $8.2 million of tax deductions from the exercise of stock options. The Company has also recorded a deferred tax asset of approximately $1.8 million at December 31, 2013, reflecting the benefit of the deduction from the exercise of stock options which has been fully reserved until it is more likely than not that the benefit will be realized. The benefit from these deductions will be recorded as a credit to additional paid-in capital if and when realized through a reduction of taxes paid in cash. | |
As required by ASC 740, management of the Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets, which are comprised principally of NOL carryforwards, research and experimentation credit carryforwards, and capitalized start up expenditures and research and development expenditures amortizable over ten years on a straight-line basis. Management has determined at this time that it is more likely than not that the Company will not recognize the benefits of its federal and state deferred tax assets and, as a result, a valuation allowance of approximately $213.9 million has been established at December 31, 2013. | |
Utilization of the NOLs and tax credit carryforwards may be subject to a substantial annual limitation due to ownership change limitations that have occurred previously or that could occur in the future, as provided by Section 382 of the Internal Revenue Code of 1986 (Section 382), as well as similar state and foreign provisions. Ownership changes may limit the amount of NOLs and tax credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively. In general, an ownership change, as defined by Section 382, results from transactions that increase the ownership of 5% shareholders or public groups in the stock of a corporation by more than 50 percent in the aggregate over a three-year period. The Company completed a study to determine whether any ownership change has occurred since the Company's formation and has determined that transactions have resulted in two ownership changes, as defined by Section 382 as of December 31, 2013. There could be additional ownership changes in the future that could further limit the amount of NOLs and tax credit carryforwards that the Company can utilize. | |
As of December 31, 2013, the Company’s unrestricted federal tax NOLs available to reduce future taxable income without limitation are $262.0 million, which expire at various times beginning in 2024 through 2033. The Company’s federal research and experimentation and orphan drug credit carryforward as of December 31, 2013 available to reduce future tax liabilities without limitation are $56.8 million, which will expire at various dates beginning in 2024 through 2033. In addition, the Company has NOLs and federal tax credits that are restricted and expire at various times beginning in 2018 through 2024. These restricted NOLs and federal tax credits of $67.2 million and $4.8 million, respectively, may be utilized in part, subject to an annual limitation. Ownership changes after December 31, 2013 could further restrict the use of these NOLs and federal tax credits. | |
SUMMARY_OF_SIGNIFICANT_ACCOUNT1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 6 Months Ended | ||||||||||||||||
Jun. 30, 2014 | |||||||||||||||||
Accounting Policies [Abstract] | ' | ||||||||||||||||
Basis of Presentation | ' | ||||||||||||||||
Basis of Presentation | |||||||||||||||||
The accompanying unaudited interim consolidated financial statements have been prepared by the Company in accordance with accounting principles generally accepted in the United States of America (GAAP) for interim financial information. It is management’s opinion that the accompanying unaudited interim consolidated financial statements reflect all adjustments (which are normal and recurring) necessary for a fair statement of the results for the interim periods. The financial statements should be read in conjunction with the consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2013. The accompanying December 31, 2013 consolidated balance sheet was derived from audited financial statements, but does not include all disclosures required by GAAP. | |||||||||||||||||
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect (i) the reported amounts of assets and liabilities, (ii) disclosure of contingent assets and liabilities at the dates of the financial statements and (iii) the reported amounts of revenue and expenses during the reporting periods. Actual results could differ from those estimates. The results of operations for the three and six months ended June 30, 2014 are not necessarily indicative of the results that may be expected for the year ending December 31, 2014. | |||||||||||||||||
Basis of Consolidation | ' | ||||||||||||||||
Basis of Consolidation | |||||||||||||||||
The accompanying consolidated financial statements include the accounts of the Company and the Company's European subsidiaries Dyax S.A. and Dyax BV. All inter-company accounts and transactions have been eliminated. | |||||||||||||||||
Use of Estimates | ' | ||||||||||||||||
Use of Estimates | |||||||||||||||||
The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make certain estimates and assumptions that affect the amounts of assets and liabilities reported and disclosure of contingent assets and liabilities at the dates of the financial statements and the reported amounts of revenue and expenses during the reporting periods. The significant estimates and assumptions in these financial statements include revenue recognition for licensing and collaboration agreements, product sales allowances, royalty interest obligations, useful lives with respect to long-lived assets, valuation of stock options, clinical trial accruals and other accrued expenses and tax valuation reserves. Actual results could differ from those estimates. | |||||||||||||||||
Concentration of Credit Risk | ' | ||||||||||||||||
Concentration of Credit Risk | |||||||||||||||||
Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash, cash equivalents, short-term investments and trade accounts receivable. At June 30, 2014 and December 31, 2013, approximately 96% and 89%, respectively, of the Company's cash, cash equivalents and short-term investments were invested in money market funds backed by U.S. Treasury obligations, U.S. Treasury notes and bills, and obligations of United States government agencies held by one financial institution. The Company maintains balances in various operating accounts in excess of federally insured limits. | |||||||||||||||||
The Company provides most of its services and licenses its technology to pharmaceutical and biomedical companies worldwide, and makes all product sales to its distributors. Concentrations of credit risk with respect to trade receivable balances associated with the Company’s development and license fee revenue are usually limited on an ongoing basis, due to the diverse number of licensees and collaborators comprising the Company's customer base. Trade receivable balances associated with the Company’s product sales are comprised of only a few customers, due to the limited number of distributors the Company uses in its distribution network. The Company completes ongoing credit evaluations of their customers. As of June 30, 2014, two customers accounted for 41% (US Bio) and 18% (Walgreens) of the accounts receivable balance. As of December 31, 2013, two customers accounted for 35% (US Bio) and 26% (Walgreens) of the accounts receivable balance. | |||||||||||||||||
Cash and Cash Equivalents | ' | ||||||||||||||||
Cash and Cash Equivalents | |||||||||||||||||
All highly liquid investments purchased with an original maturity of ninety days or less are considered to be cash equivalents. Cash and cash equivalents consist of cash, money market and U.S. Treasury funds. | |||||||||||||||||
Investments | ' | ||||||||||||||||
Investments | |||||||||||||||||
Short-term investments consist of investments with original maturities greater than ninety days and remaining maturities less than one year at period end. The Company has also classified its investments with maturities beyond one year as short-term, based on their highly liquid nature and as these marketable securities represent the investment of cash that is available for current operations. The Company considers its portfolio of investments as available-for-sale. Accordingly, these investments are recorded at fair value, which is based on quoted market prices. As of June 30, 2014, the Company's investments consisted of U.S. Treasury notes and bills with an amortized cost of $157.6 million, an estimated fair value of $157.7 million, and had an unrealized gain of $93,000, which has been recorded in other comprehensive income. As of December 31, 2013, the Company's investments consisted of United States Treasury notes and bills with an estimated fair value and amortized cost of $43.3 million, and had an unrealized gain of $3,000, which is recorded in other comprehensive income. | |||||||||||||||||
Inventories | ' | ||||||||||||||||
Inventories | |||||||||||||||||
Inventories are stated at the lower of cost or market with cost determined under the first-in, first-out, or FIFO, basis. The Company evaluates inventory levels and would write-down inventory that is expected to expire prior to being sold, inventory that has a cost basis in excess of its expected net realizable value, inventory in excess of expected sales requirements, or inventory that fails to meet commercial sale specifications, through a charge to cost of product sales. Included in the cost of inventory are capitalized employee stock-based compensation costs for those employees dedicated to manufacturing efforts. Inventory on-hand that will be sold beyond the Company's normal operating cycle is classified as non-current and grouped with other assets on the Company's consolidated balance sheet. | |||||||||||||||||
Fixed Assets | ' | ||||||||||||||||
Fixed Assets | |||||||||||||||||
Property and equipment are recorded at cost and depreciated over the estimated useful lives of the related assets using the straight-line method. Laboratory and production equipment, furniture and office equipment are depreciated over a three to seven year period. Leasehold improvements are stated at cost and are amortized over the lesser of the non-cancelable term of the related lease or their estimated useful lives. Leased equipment is amortized over the lesser of the life of the lease or their estimated useful lives. Maintenance and repairs are charged to expense as incurred. When assets are retired or otherwise disposed of, the cost of these assets and related accumulated depreciation and amortization are eliminated from the balance sheet and any resulting gains or losses are included in operations in the period of disposal. | |||||||||||||||||
The Company records all proceeds received from the lessor for tenant improvements under the terms of its operating lease as deferred rent. The amounts are amortized on a straight-line basis over the term of the lease as an offset to rent expense. | |||||||||||||||||
Impairment of Long-Lived Assets | ' | ||||||||||||||||
Impairment of Long-Lived Assets | |||||||||||||||||
The Company’s long-lived assets, consisting primarily of fixed assets, are reviewed for impairment whenever events or changes in business circumstances indicate that the carrying amount of assets may not be fully recoverable or that the useful lives of these assets are no longer appropriate. Each impairment test is based on a comparison of the undiscounted cash flow to the recorded value of the asset. If impairment is indicated, the asset is written down to its estimated fair value, which is computed based on a discounted cash flow basis. | |||||||||||||||||
Revenue Recognition | ' | ||||||||||||||||
Revenue Recognition | |||||||||||||||||
The Company’s principal sources of revenue are product sales of KALBITOR and license fees, funding for research and development, and milestones and royalties derived from collaboration and license agreements. In all instances, revenue is recognized only when the price is fixed or determinable, persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, collectability of the resulting receivable is reasonably assured and the Company has no further performance obligations. | |||||||||||||||||
Product Sales and Allowances | ' | ||||||||||||||||
Product Sales and Allowances | |||||||||||||||||
Product Sales. Product sales are generated from the sale of KALBITOR to the Company’s customers, primarily wholesale and specialty distributors, and are recorded upon delivery when title and risk of loss have passed to the customer. Product sales are recorded net of applicable reserves for distributors, prompt pay and other discounts, government rebates, patient financial assistance programs, product returns and other applicable allowances. | |||||||||||||||||
Product Sales Allowances. The Company establishes reserves for trade distributor, prompt pay and volume discounts, government rebates, patient financial assistance programs, product returns and other applicable allowances. Reserves established for these discounts and allowances are classified as a reduction of accounts receivable (if the amount is payable to the customer) or a liability (if the amount is payable to a party other than the customer). | |||||||||||||||||
Allowances against receivable balances primarily relate to prompt payment discounts and are recorded at the time of sale, resulting in a reduction in product sales revenue. Accruals related to government rebates, patient financial assistance programs, product returns and other applicable allowances are recognized at the time of sale, resulting in a reduction in product sales revenue and the recording of an increase in accrued expenses. | |||||||||||||||||
The Company maintains service contracts with its distributors. These contracts include services such as inventory maintenance and patient support services. Accounting standards related to consideration given by a vendor to a customer, including a reseller of a vendor’s product, specify that each consideration given by a vendor to a customer is presumed to be a reduction of the selling price. Consideration should be characterized as a cost if the company receives, or will receive, an identifiable benefit in exchange for the consideration, and fair value of the benefit can be reasonably estimated. The Company has established that patient support services are at fair value and represent a separate and identifiable benefit because these services could be provided by separate third-party vendors. Accordingly, these costs are classified as selling, general and administrative expense. | |||||||||||||||||
Inventory maintenance fees are calculated as a percentage of KALBITOR sales price and accordingly, are classified as a reduction in product sales revenue. | |||||||||||||||||
Prompt Payment and Other Discounts. The Company offers a prompt payment discount to its United States distributors. Since the Company expects that these distributors will take advantage of this discount, the Company accrues 100% of the prompt payment discount that is based on the gross amount of each invoice, at the time of sale. This accrual is adjusted quarterly to reflect actual earned discounts. The Company also offers volume discounts to certain distributors which are accrued quarterly based on sales during the period. | |||||||||||||||||
Government Rebates and Chargebacks. The Company estimates reductions to product sales for Medicaid and Veterans' Administration (VA) programs and the Medicare Part D Coverage Gap Program, as well as for certain other qualifying federal and state government programs. The Company estimates the amount of these reductions based on available KALBITOR patient data, actual sales data and rebate claims. These allowances are adjusted each period based on actual experience. | |||||||||||||||||
Medicaid rebate reserves relate to the Company’s estimated obligations to state jurisdictions under the established reimbursement arrangements of each applicable state. Rebate accruals are recorded during the same period in which the related product sales are recognized. Actual rebate amounts are determined at the time of claim by the state, and the Company will generally make cash payments for such amounts after receiving billings from the state. | |||||||||||||||||
VA rebates or chargeback reserves represent the Company’s estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at a price lower than the list price charged to the Company’s distributor. The distributor will charge the Company for the difference between what the distributor pays for the product and the ultimate selling price to the qualified healthcare provider. Rebate accruals are established during the same period in which the related product sales are recognized. Actual chargeback amounts for Public Health Service are determined at the time of resale to the qualified healthcare provider from the distributor, and the Company will generally issue credits for such amounts after receiving notification from the distributor. | |||||||||||||||||
Although allowances and accruals are recorded at the time of product sale, certain rebates are typically paid out, on average, up to six months or longer after the sale. Reserve estimates are evaluated quarterly and if necessary, adjusted to reflect actual results. Any such adjustments will be reflected in the Company’s operating results in the period of the adjustment. | |||||||||||||||||
Product Returns. Allowances for product returns are recorded during the period in which the related product sales are recognized, resulting in a reduction to product revenue. The Company does not provide its distributors with a general right of product return. The Company permits returns if the product is damaged or defective when received by customers or if the product shelf life has expired. The Company estimates product returns based upon actual returns history and data provided by a distributor. | |||||||||||||||||
Patient Financial Assistance. The Company offers a financial assistance program for commercially insured KALBITOR patients in order to defray patients’ out-of-pocket expenses, including co-payments, to aid patients’ access to KALBITOR. The Company estimates its liability for this program based on actual but unpaid reimbursements, as well as, an estimated reserve for product sold to and held by distributors as of period end, based on the Company’s historical redemption rates. | |||||||||||||||||
An analysis of the amount of, and change in, reserves related to sales allowances is summarized as follows: | |||||||||||||||||
(In thousands) | Prompt pay | Patient | Government | Returns | Total | ||||||||||||
and other | financial | rebates and | |||||||||||||||
discounts | assistance | chargebacks | |||||||||||||||
Balance, as of December 31, 2012 | $ | 388 | $ | 165 | $ | 565 | $ | 551 | $ | 1,669 | |||||||
Current provisions relating to sales in current year | 2,565 | 498 | 2,806 | 145 | 6,014 | ||||||||||||
Adjustments relating to prior years | 23 | -38 | -79 | -141 | -235 | ||||||||||||
Payments relating to sales in current year | -2,165 | -378 | -1,380 | — | -3,923 | ||||||||||||
Payments/returns relating to sales in prior years | -327 | -157 | -278 | -232 | -994 | ||||||||||||
Balance, as of December 31, 2013 | 484 | 90 | 1,634 | 323 | 2,531 | ||||||||||||
Current provisions relating to sales in current year | 1,556 | 179 | 1,425 | 89 | 3,249 | ||||||||||||
Adjustments relating to prior years | 6 | 1 | -6 | -18 | -17 | ||||||||||||
Payments relating to sales in current year | -1,370 | -145 | -494 | — | -2,009 | ||||||||||||
Payments/returns relating to sales in prior years | -383 | -16 | -902 | -53 | -1,354 | ||||||||||||
Balance, as of June 30, 2014 | $ | 293 | $ | 109 | $ | 1,657 | $ | 341 | $ | 2,400 | |||||||
Development and License Fee Revenues | ' | ||||||||||||||||
Development and License Fee Revenues | |||||||||||||||||
Collaboration Agreements. The Company enters into collaboration agreements with other companies for the research and development of therapeutic and diagnostic products. The terms of the agreements may include non-refundable signing and licensing fees, funding for research and development, payments related to manufacturing services, milestone payments and royalties on any product sales derived from collaborations. These multiple element arrangements are analyzed to determine how the deliverables, which often include license and performance obligations such as research, steering committee and manufacturing services, are separated into units of accounting. | |||||||||||||||||
For agreements entered into prior to 2011, the Company evaluated license arrangements with multiple elements in accordance with Accounting Standards Codification (ASC), 605-25 Revenue Recognition – Multiple-Element Arrangements. Since 2011, the Company has applied the guidance of ASU 2009-13 to evaluate license arrangements with multiple elements. This guidance amended the accounting standards for certain multiple element arrangements to: | |||||||||||||||||
· | Provide updated guidance on whether multiple elements exist, how the elements in an arrangement should be separated and how the arrangement considerations should be allocated to the separate elements; | ||||||||||||||||
· | Require an entity to allocate arrangement consideration to each element based on a selling price hierarchy, also called the relative selling price method, where the selling price for an element is based on vendor-specific objective evidence (VSOE), if available; third-party evidence (TPE), if available and VSOE is not available; or the best estimate of selling price (BESP), if neither VSOE or TPE is available; and | ||||||||||||||||
· | Eliminate the use of the residual method and require an entity to allocate arrangement consideration using the selling price hierarchy. | ||||||||||||||||
The Company evaluates all deliverables within an arrangement to determine whether or not they provide value to the licensee on a stand-alone basis. Based on this evaluation, the deliverables are separated into units of accounting. If VSOE or VOE is not available to determine the fair value of a deliverable, the Company determines the best estimate of selling price associated with the deliverable. The arrangement consideration, including upfront license fees and funding for research and development, is allocated to the separate units based on relative fair value. | |||||||||||||||||
VSOE is based on the price charged when an element is sold separately and represents the actual price charged for that deliverable. When VSOE cannot be established, we attempt to establish the selling price of the elements of a license arrangement based on VOE. VOE is determined based on third party evidence for similar deliverables when sold separately. In circumstances when the Company charges a licensee for pass-through costs paid to external vendors for development services, these costs represent VOE. | |||||||||||||||||
When we are unable to establish the selling price of an element using VSOE or VOE, management determines BESP for that element. The objective of BESP is to determine the price at which we would transact a sale if the element within the license agreement was sold on a stand-alone basis. Our process for establishing BESP involves management’s judgment and considers multiple factors including discounted cash flows, estimated direct expenses and other costs and available data. | |||||||||||||||||
Based on the value allocated to each unit of accounting within an arrangement, upfront fees and other guaranteed payments are allocated to each unit based on relative value. The appropriate revenue recognition method is applied to each unit and revenue is accordingly recognized as each unit is delivered. | |||||||||||||||||
For agreements entered into prior to 2011, revenue related to upfront license fees was spread over the full period of performance under the agreement, unless the license was determined to provide value to the licensee on a stand-alone basis and the fair value of the undelivered performance obligations, typically including research or steering committee services was determinable. | |||||||||||||||||
Steering committee services that were not inconsequential or perfunctory and were determined to be performance obligations were combined with other research services or performance obligations required under an arrangement, if any, to determine the level of effort required in an arrangement and the period over which the Company expected to complete its aggregate performance obligations. | |||||||||||||||||
Whenever the Company determined that an arrangement should be accounted for as a single unit of accounting, it determined the period over which the performance obligations would be completed. Revenue is recognized using either an efforts-based or time-based proportional performance (i.e. straight-line) method. The Company recognizes revenue using an efforts-based proportional performance method when the level of effort required to complete its performance obligations under an arrangement can be reasonably estimated and such performance obligations are provided on a best-efforts basis. Direct labor hours or full-time equivalents are typically used as the measurement of performance. | |||||||||||||||||
If the Company cannot reasonably estimate the level of effort to complete its performance obligations under an arrangement, then revenue under the arrangement is recognized on a straight-line basis over the period the Company is expected to complete its performance obligations. | |||||||||||||||||
Many of the Company's collaboration agreements entitle it to additional payments upon the achievement of performance-based milestones. Milestones that are tied to development or regulatory approval are not considered probable of being achieved until such approval is received. All milestones which are determined to be substantive milestones are recognized as revenue in the period in which they are met in accordance with Accounting Standards Update (ASU) No. 2010-17, Revenue Recognition – Milestone Method. Milestones tied to counter-party performance are not included in the Company’s revenue model until performance conditions are met. Milestones determined to be non-substantive are allocated to each unit of accounting within an arrangement when met. The allocation of the milestone to each unit is based on relative value and revenue related to each unit is recognized accordingly. | |||||||||||||||||
Costs of revenues related to licensees’ product development, including license fees and development and regulatory milestones are classified as research and development in the consolidated statements of operations and comprehensive loss. | |||||||||||||||||
Phage Display Library Licenses. Standard terms of the proprietary phage display library agreements generally include non-refundable signing fees, license maintenance fees, development milestone payments, product license payments and royalties on product sales. Signing fees and maintenance fees are generally recognized on a straight line basis over the term of the agreement as deliverables within these arrangements are determined to not provide the licensee with value on a stand-alone basis and therefore are accounted for as a single unit of accounting. As milestones are achieved under a phage display library license, a portion of the milestone payment, equal to the percentage of the performance period completed when the milestone is achieved, multiplied by the amount of the milestone payment, will be recognized. The remaining portion of the milestone will be recognized over the remaining performance period on a straight-line basis. If the Company has no future obligations under the license, milestone payments under these license arrangements are recognized as revenue when the milestone is achieved. Product license payments, which are optional to the licensee, are substantive and therefore are excluded from the initial allocation of the arrangement consideration. These payments are recognized as revenue when the license is issued upon exercise of the licensee’s option, if the Company has no future obligations under the agreement. If there are future obligations under the agreement, product license payments are recognized as revenue only to the extent of the fair value of the license. Amounts paid in excess of fair value are recognized in a manner similar to milestone payments. Payments received that have not met the appropriate criteria for revenue recognition are recorded as deferred revenue. | |||||||||||||||||
Phage Display Patent Licenses. The Company previously licensed its phage display patents on a non-exclusive basis to third parties for use in connection with the research and development of therapeutic, diagnostic, and other products. The core patents in this portfolio expired in November 2012. Even after patent expiration, the Company generally remains eligible under these patent licenses to receive milestones and/or royalties for products discovered prior to patent expiration, although certain existing patent licenses will no longer have a royalty obligation. The Company does not expect the expiration of these patents to have a material impact on the LFRP. | |||||||||||||||||
Standard terms of the patent rights agreements include non-refundable signing fees, non-refundable license maintenance fees, development milestone payments and/or royalties on product sales. Signing fees and maintenance fees are generally recognized on a straight line basis over the term of the agreement or through the date of patent expiry, if shorter, except that in the case of perpetual patent licenses for which fees were recognized immediately if it was determined that the Company had no future obligations under the agreement and the payments were made upfront. If the Company has no remaining performance obligations under the patent license agreement, milestones are recognized as revenue in the period in which the milestone is achieved. | |||||||||||||||||
LFRP Milestones | |||||||||||||||||
Non-substantive Milestones. Under the LFRP licenses, the Company is eligible to receive clinical development, regulatory filing and marketing approval milestones, which vary from licensee to licensee. Achievement of these milestones is contingent upon each licensee’s efforts and involves risks and uncertainty related to drug development, regulatory approval and intellectual property that could lead to milestones never being met. | |||||||||||||||||
Based on information available to the Company regarding pre-clinical and clinical candidates in the LFRP, developed using its technology and through intellectual property rights granted, it is estimated that the Company could receive up to $81 million in development milestones, $68 million in regulatory filing milestones and $96 million in marketing approval milestones. As achievement of these milestones is outside the control of the Company and is contingent upon the licensees’ efforts, they have been determined to be non-substantive milestones. | |||||||||||||||||
The Company recognized revenue of approximately $2.1 million related to milestones from the LFRP for each of the three and six months ended June 30, 2014 and approximately $75,000 and $1.3 million for the three and six months ended June 30, 2013, respectively. | |||||||||||||||||
Substantive Milestones. Under certain collaboration agreements, the Company performs funded research for various collaborators using its phage display technology and libraries. These arrangements typically include technical milestones that are based on agreed upon objectives to be met under the research campaign, which are considered to be commensurate with the Company’s performance and therefore have been determined to be substantive milestones. | |||||||||||||||||
There was no amount recognized for technical milestones during the three and six months ended June 30, 2014 and 2013. The Company is not eligible to receive any future technical milestones at this time. | |||||||||||||||||
Non-LFRP Milestones | |||||||||||||||||
In certain countries outside of the U.S., the Company has entered into licensing agreements for the development and commercialization of KALBITOR for the treatment of HAE and other angioedema indications. Under these agreements, the Company is eligible to receive certain development and sales milestones. See Note 3, Significant Transactions. | |||||||||||||||||
Royality Revenues | ' | ||||||||||||||||
Royalty Revenues | |||||||||||||||||
Royalty revenue is recognized when it becomes determinable and collectability is reasonably assured; otherwise the Company recognizes royalty revenue upon receipt of payment. | |||||||||||||||||
Cost of Product Sales | ' | ||||||||||||||||
Cost of Product Sales | |||||||||||||||||
Cost of product sales includes costs to procure, manufacture and distribute KALBITOR and manufacturing royalties. Costs associated with the manufacture of KALBITOR prior to regulatory approval in the United States were expensed when incurred as a research and development cost and accordingly, KALBITOR units sold during the three and six months ended June 30, 2013 do not include the full cost of drug manufacturing. For the three and six months ended June 30, 2014, KALBITOR units sold included the full cost of drug manufacturing. | |||||||||||||||||
Research and Development | ' | ||||||||||||||||
Research and Development | |||||||||||||||||
Research and development costs include all direct costs, including salaries and benefits for research and development personnel, outside consultants, costs of clinical trials, sponsored research, clinical trials insurance, other outside costs, depreciation and facility costs related to the development of drug candidates, as well as certain pass-through costs under the Company’s cross license agreements related to product development by its LFRP licensees, including license fees and development and regulatory milestones. | |||||||||||||||||
Income Taxes | ' | ||||||||||||||||
Income Taxes | |||||||||||||||||
The Company utilizes the asset and liability method of accounting for income taxes in accordance with ASC 740. Under this method, deferred tax assets and liabilities are recognized for the expected future tax consequences of temporary differences between the carrying amounts and the tax basis of assets and liabilities using the enacted statutory tax rates. At June 30, 2014 and December 31, 2013, there were no unrecognized tax benefits. | |||||||||||||||||
The Company accounts for uncertain tax positions using a "more-likely-than-not" threshold for recognizing and resolving uncertain tax positions. The evaluation of uncertain tax positions is based on factors that include, but are not limited to, changes in tax law, the measurement of tax positions taken or expected to be taken in tax returns, the effective settlement of matters subject to audit, new audit activity and changes in facts or circumstances related to a tax position. The Company evaluates uncertain tax positions on a quarterly basis and adjusts the level of the liability to reflect any subsequent changes in the relevant facts surrounding the uncertain positions. | |||||||||||||||||
Translation of Foreign Currencies | ' | ||||||||||||||||
Translation of Foreign Currencies | |||||||||||||||||
Assets and liabilities of the Company's foreign subsidiaries are translated at period end exchange rates. Amounts included in the statements of operations are translated at the average exchange rate for the period. All currency translation adjustments are recorded to other income (expense) in the consolidated statement of operations and comprehensive loss. The Company recorded income of $3,000 for each of the three and six months ended June 30, 2014 for the translation of foreign currency. For the three and six months ending June 30, 2013 the Company recorded other income of $6,000 and other expense of $2,000, respectively, for the translation of foreign currency. | |||||||||||||||||
Share-Based Compensation | ' | ||||||||||||||||
Share-Based Compensation | |||||||||||||||||
The Company’s share-based compensation program consists of share-based awards granted to employees in the form of stock options and restricted stock units (RSUs), as well as its 1998 Employee Stock Purchase Plan, as amended (the Purchase Plan). The Company’s share-based compensation expense is recorded in accordance with ASC 718. | |||||||||||||||||
Income or Loss Per Share | ' | ||||||||||||||||
Income or Loss Per Share | |||||||||||||||||
The Company follows the two-class method when computing net loss per share, as it had issued shares that met the definition of participating securities. The two-class method determines net loss per share for each class of common and participating securities according to dividends declared or accumulated and participation rights in undistributed earnings. The two-class method requires income available to common stockholders for the period to be allocated between common and participating securities based upon their respective rights to receive dividends, as if all income for the period had been distributed. | |||||||||||||||||
The Company presents two earnings or loss per share (EPS) amounts, basic and diluted in accordance with ASC 260. Basic earnings or loss per share is computed using the weighted average number of shares of common stock outstanding. Diluted net loss per share does not differ from basic net loss per share since potential common shares from the exercise of stock options, warrants or rights under the Purchase Plan are anti-dilutive for the three and six months ended June 30, 2014 and 2013, and therefore, are excluded from the calculation of diluted net loss per share. | |||||||||||||||||
The weighted average of stock options outstanding totaled 12,181,512 as of June 30, 2014, and the weighted average of stock options and warrants outstanding totaled 14,053,495 as of June 30, 2013. | |||||||||||||||||
Comprehensive Income (Loss) | ' | ||||||||||||||||
Comprehensive Income (Loss) | |||||||||||||||||
The Company accounts for comprehensive income (loss) under ASC 220, Comprehensive Income, which established standards for reporting and displaying comprehensive income (loss) and its components in a full set of general purpose financial statements. The statement required that all components of comprehensive income (loss) be reported in a financial statement that is displayed with the same prominence as other financial statements. The Company is presenting comprehensive income (loss) as part of the consolidated statements of operations and comprehensive loss. | |||||||||||||||||
Business Segments | ' | ||||||||||||||||
Business Segments | |||||||||||||||||
The Company discloses business segments under ASC 280, Segment Reporting. The statement established standards for reporting information about operating segments and disclosures about products and services, geographic areas and major customers. The Company operates as one business segment within predominantly one geographic area. | |||||||||||||||||
New Accounting Pronouncements | ' | ||||||||||||||||
New Accounting Pronouncements | |||||||||||||||||
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (FASB) or other standard setting bodies, which are adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption. | |||||||||||||||||
In May 2014, the FASB issued an amendment which will replace most of the existing revenue recognition guidance within U.S. GAAP. The core principle of this guidance is that an entity should recognize revenue for the transfer of goods or services to customers in an amount that it expects to be entitled to receive for those goods or services. In doing so, companies will be required to make certain judgments and estimates, including identifying contract performance obligations, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price among separate performance obligations. Additionally, the amendment requires disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, significant judgments reached in the application of the guidance and assets recognized from the costs to obtain or fulfill a contract. Effective for the Company beginning on January 1, 2017, the amendment allows for two methods of adoption, a full retrospective method or a modified retrospective approach with the cumulative effect recognized at the date of initial application. Early adoption is not permitted. The Company is in the process of determining the method of adoption and the impact of this amendment on its consolidated financial statements. | |||||||||||||||||
SUMMARY_OF_SIGNIFICANT_ACCOUNT2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 6 Months Ended | ||||||||||||||||
Jun. 30, 2014 | |||||||||||||||||
Accounting Policies [Abstract] | ' | ||||||||||||||||
Reserves Related to Sales Allowances | ' | ||||||||||||||||
An analysis of the amount of, and change in, reserves related to sales allowances is summarized as follows: | |||||||||||||||||
(In thousands) | Prompt pay | Patient | Government | Returns | Total | ||||||||||||
and other | financial | rebates and | |||||||||||||||
discounts | assistance | chargebacks | |||||||||||||||
Balance, as of December 31, 2012 | $ | 388 | $ | 165 | $ | 565 | $ | 551 | $ | 1,669 | |||||||
Current provisions relating to sales in current year | 2,565 | 498 | 2,806 | 145 | 6,014 | ||||||||||||
Adjustments relating to prior years | 23 | -38 | -79 | -141 | -235 | ||||||||||||
Payments relating to sales in current year | -2,165 | -378 | -1,380 | — | -3,923 | ||||||||||||
Payments/returns relating to sales in prior years | -327 | -157 | -278 | -232 | -994 | ||||||||||||
Balance, as of December 31, 2013 | 484 | 90 | 1,634 | 323 | 2,531 | ||||||||||||
Current provisions relating to sales in current year | 1,556 | 179 | 1,425 | 89 | 3,249 | ||||||||||||
Adjustments relating to prior years | 6 | 1 | -6 | -18 | -17 | ||||||||||||
Payments relating to sales in current year | -1,370 | -145 | -494 | — | -2,009 | ||||||||||||
Payments/returns relating to sales in prior years | -383 | -16 | -902 | -53 | -1,354 | ||||||||||||
Balance, as of June 30, 2014 | $ | 293 | $ | 109 | $ | 1,657 | $ | 341 | $ | 2,400 | |||||||
FAIR_VALUE_MEASUREMENTS_Tables
FAIR VALUE MEASUREMENTS (Tables) | 6 Months Ended | |||||||||||||
Jun. 30, 2014 | ||||||||||||||
Fair Value Disclosures [Abstract] | ' | |||||||||||||
Financial Assets Measured at Fair Value | ' | |||||||||||||
Fair values determined by Level 3 inputs utilize unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. | ||||||||||||||
Description (in thousands) | June 30, | Quoted | Significant | Significant | ||||||||||
2014 | Prices in | Other | Unobservable | |||||||||||
Active | Observable | Inputs | ||||||||||||
Markets | Inputs | (Level 3) | ||||||||||||
(Level 1) | (Level 2) | |||||||||||||
Assets: | ||||||||||||||
Money Market Funds | $ | 23,159 | $ | 23,159 | $ | — | $ | — | ||||||
Marketable debt securities | 157,688 | — | 157,688 | — | ||||||||||
Total | $ | 180,847 | $ | 23,159 | $ | 157,688 | $ | — | ||||||
Description (in thousands) | December 31, | Quoted | Significant | Significant | ||||||||||
2013 | Prices in | Other | Unobservable | |||||||||||
Active | Observable | Inputs | ||||||||||||
Markets | Inputs | (Level 3) | ||||||||||||
(Level 1) | (Level 2) | |||||||||||||
Assets: | ||||||||||||||
Money Market Funds | $ | 55,569 | $ | 55,569 | $ | — | $ | — | ||||||
Marketable debt securities | 43,296 | — | 43,296 | — | ||||||||||
Total | $ | 98,865 | $ | 55,569 | $ | 43,296 | $ | — | ||||||
Marketable Securities | ' | |||||||||||||
The following tables summarize the Company’s marketable securities at June 30, 2014 and December 31, 2013: | ||||||||||||||
June 30, 2014 | ||||||||||||||
Description (in thousands) | Amortized | Gross | Gross | Fair Value | ||||||||||
Cost | Unrealized | Unrealized | ||||||||||||
Gains | Losses | |||||||||||||
US Treasury Bills and Notes (due within 1 year) | $ | 72,262 | $ | 53 | $ | — | $ | 72,315 | ||||||
US Treasury Bills and Notes | 85,333 | 40 | — | 85,373 | ||||||||||
(due after 1 year through 2 years) | ||||||||||||||
Total | $ | 157,595 | $ | 93 | $ | — | $ | 157,688 | ||||||
December 31, 2013 | ||||||||||||||
Description (in thousands) | Amortized | Gross | Gross | Fair Value | ||||||||||
Cost | Unrealized | Unrealized | ||||||||||||
Gains | Losses | |||||||||||||
US Treasury Bills and Notes (due within 1 year) | $ | 2,001 | $ | 1 | $ | — | $ | 2,002 | ||||||
US Treasury Bills and Notes | 41,292 | 2 | — | 41,294 | ||||||||||
(due after 1 year through 2 years) | ||||||||||||||
Total | $ | 43,293 | $ | 3 | $ | — | $ | 43,296 | ||||||
INVENTORY_Tables
INVENTORY (Tables) | 6 Months Ended | |||||||
Jun. 30, 2014 | ||||||||
Inventory Disclosure [Abstract] | ' | |||||||
Components of Inventory | ' | |||||||
Inventory consists of the following: | ||||||||
June 30, | December 31, | |||||||
2014 | 2013 | |||||||
(in thousands) | ||||||||
Raw Materials | $ | 1,116 | $ | 1,116 | ||||
Work in Progress | 5,277 | 5,965 | ||||||
Finished Goods | 1,422 | 1,281 | ||||||
Total | $ | 7,815 | $ | 8,362 | ||||
FIXED_ASSETS_Tables
FIXED ASSETS (Tables) | 6 Months Ended | |||||||
Jun. 30, 2014 | ||||||||
Property Plant And Equipment [Abstract] | ' | |||||||
Components of Fixed Assets | ' | |||||||
Fixed assets consist of the following: | ||||||||
June 30, | December 31, | |||||||
2014 | 2013 | |||||||
(in thousands) | ||||||||
Laboratory equipment | $ | 3,932 | $ | 3,932 | ||||
Furniture and office equipment | 849 | 815 | ||||||
Software and computers | 2,968 | 2,958 | ||||||
Leasehold improvements | 4,554 | 4,510 | ||||||
Total | 12,303 | 12,215 | ||||||
Less: accumulated depreciation | -7,626 | -7,255 | ||||||
$ | 4,677 | $ | 4,960 | |||||
ACCOUNTS_PAYABLE_AND_ACCRUED_E1
ACCOUNTS PAYABLE AND ACCRUED EXPENSES (Tables) | 6 Months Ended | |||||||
Jun. 30, 2014 | ||||||||
Payables And Accruals [Abstract] | ' | |||||||
Components of Accounts Payable and Accrued Expenses | ' | |||||||
Accounts payable and accrued expenses consist of the following: | ||||||||
June 30, | December 31, | |||||||
2014 | 2013 | |||||||
(in thousands) | ||||||||
Accounts payable | $ | 1,096 | $ | 1,407 | ||||
Accrued employee compensation and related taxes. | 3,921 | 4,609 | ||||||
Accrued external research and development and sales expenses | 1,498 | 1,778 | ||||||
Accrued legal | 664 | 456 | ||||||
Accrued sales allowances | 1,948 | 1,918 | ||||||
Other accrued liabilities | 1,342 | 2,374 | ||||||
Total | $ | 10,469 | $ | 12,542 | ||||
LONGTERM_OBLIGATIONS_Tables
LONG-TERM OBLIGATIONS (Tables) | 6 Months Ended | |||||||
Jun. 30, 2014 | ||||||||
Debt Disclosure [Abstract] | ' | |||||||
Activity under Loan Presented for Financial Reporting Purposes | ' | |||||||
Activity under the Loan, adjusted for discounts associated with the debt issuance, including warrants and fees, is presented for financial reporting purposes for the six months ended June 30, 2014 and for the year ended December 31, 2013, as follows: | ||||||||
June 30, 2014 | December 31, 2013 | |||||||
(in thousands) | ||||||||
Beginning balance | $ | 81,516 | $ | 78,061 | ||||
Accretion of discount | 99 | 198 | ||||||
Loan activity: | ||||||||
Interest Expense | 5,292 | 10,447 | ||||||
Payments applied to principal | — | — | ||||||
Payments applied to interest | -2,726 | -5,378 | ||||||
Accrued interest payable | -2,342 | -1,812 | ||||||
Ending balance | $ | 81,839 | $ | 81,516 | ||||
STOCKHOLDERS_EQUITY_AND_STOCKB1
STOCKHOLDER'S EQUITY AND STOCK-BASED COMPENSATION (Tables) | 6 Months Ended | |||||||||||||
Jun. 30, 2014 | ||||||||||||||
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ' | |||||||||||||
Stock Options Activity | ' | |||||||||||||
The following table summarizes stock option activity for the period ended June 30, 2014: | ||||||||||||||
Number of | Number of | |||||||||||||
Options | RSUs | |||||||||||||
Outstanding as of December 31, 2013 | 10,628,879 | 253,124 | ||||||||||||
Granted/Awarded | 2,695,159 | 352,841 | ||||||||||||
Options Exercised/Shares Issued | -855,584 | -101,877 | ||||||||||||
Cancelled | -366,076 | -22,276 | ||||||||||||
Outstanding as of June 30, 2014 | 12,102,378 | 481,812 | ||||||||||||
Exercisable as of June 30, 2014 | 6,539,703 | — | ||||||||||||
Stock Compensation Expense | ' | |||||||||||||
The following table reflects stock compensation expense recorded, net of amounts capitalized into inventory: | ||||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||
June 30, | June 30, | |||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||
(in thousands) | ||||||||||||||
Compensation expense related to: | ||||||||||||||
Equity Incentive Plan | $ | 1,994 | $ | 879 | $ | 3,165 | $ | 2,777 | ||||||
Employee Stock Purchase Plan | 17 | 5 | 86 | 51 | ||||||||||
$ | 2,011 | $ | 884 | $ | 3,251 | 2,828 | ||||||||
Stock-based compensation expense charged to: | ||||||||||||||
Research and development | $ | 737 | $ | 280 | $ | 1,227 | $ | 508 | ||||||
Selling, general and administrative | $ | 1,274 | $ | 604 | $ | 2,024 | $ | 2,320 | ||||||
Business_Overview_Additional_I
Business Overview - Additional Information (Detail) (LFRP, Phase 3 Trials) | 6 Months Ended |
Jun. 30, 2014 | |
LFRP | Phase 3 Trials | ' |
Product Information [Line Items] | ' |
Number of products to be developed | 3 |
Recovered_Sheet1
Summary of Significant Accounting Policies - Additional Information (Detail) (USD $) | 6 Months Ended | 12 Months Ended | 3 Months Ended | 6 Months Ended | 3 Months Ended | 6 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | 6 Months Ended | 12 Months Ended | 6 Months Ended | 12 Months Ended | |||||||||
Jun. 30, 2014 | Jun. 30, 2013 | Dec. 31, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2014 | Jun. 30, 2014 | Jun. 30, 2014 | Jun. 30, 2014 | Jun. 30, 2014 | Jun. 30, 2014 | Jun. 30, 2014 | Dec. 31, 2013 | Jun. 30, 2014 | Dec. 31, 2013 | Jun. 30, 2014 | Dec. 31, 2013 | Jun. 30, 2014 | Dec. 31, 2013 | |
Customers | Customers | Foreign Exchange | Foreign Exchange | Foreign Exchange | Foreign Exchange | Not Substantive Milestones | Not Substantive Milestones | Substantive Milestones | Substantive Milestones | Development Milestones | Regulatory Filing Milestones | Marketing Approval Milestones | Walgreens Infusion Services, Inc. | Walgreens Infusion Services, Inc. | US Bioservices Corporation | US Bioservices Corporation | Cash and Cash Equivalents | Cash and Cash Equivalents | US Treasury Bills and Notes | US Treasury Bills and Notes | ||
Segment | ||||||||||||||||||||||
Location | ||||||||||||||||||||||
Significant Accounting Policies [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Concentration risk percentage | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 18.00% | 26.00% | 41.00% | 35.00% | 96.00% | 89.00% | ' | ' |
Number of financial institution in which financial instruments invested | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 1 | ' | ' | ' |
Number of major customers | 2 | ' | 2 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Available-for-sale investment amortized cost | $157,595,000 | ' | $43,293,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $157,600,000 | $43,300,000 |
Available-for-sale estimated fair value | 157,688,000 | ' | 43,296,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 157,700,000 | 43,300,000 |
Unrealized gain on available-for-sale investments | 93,000 | ' | 3,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 93,000 | 3,000 |
Percentage of prompt payment discount accrued at the time of sale | 100.00% | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Standard product warranty description | 'Although allowances and accruals are recorded at the time of product sale, certain rebates are typically paid out, on average, up to six months or longer after the sale. Reserve estimates are evaluated quarterly and if necessary, adjusted to reflect actual results. | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Milestones payment receipt | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 81,000,000 | 68,000,000 | 96,000,000 | ' | ' | ' | ' | ' | ' | ' | ' |
Revenue | ' | ' | ' | ' | ' | ' | ' | 2,100,000 | 2,100,000 | 75,000 | 1,300,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Stock options and warrants purchase | 12,181,512 | 14,053,495 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Number of business segment | 1 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Number of geographic area within which the company operates predominantly | 1 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Other Expenses | ' | ' | ' | ' | ' | ' | 2,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Other Income | ' | ' | ' | $3,000 | $6,000 | $3,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Reserves_Related_to_Sales_Allo
Reserves Related to Sales Allowances (Detail) (USD $) | 6 Months Ended | 12 Months Ended |
In Thousands, unless otherwise specified | Jun. 30, 2014 | Dec. 31, 2013 |
Valuation Allowance [Line Items] | ' | ' |
Beginning balance | $2,531 | $1,669 |
Current provisions relating to sales in current year | 3,249 | 6,014 |
Adjustments relating to prior years | -17 | -235 |
Payments relating to sales in current year | -2,009 | -3,923 |
Payments/returns relating to sales in prior years | -1,354 | -994 |
Ending balance | 2,400 | 2,531 |
Prompt pay and other discounts | ' | ' |
Valuation Allowance [Line Items] | ' | ' |
Beginning balance | 484 | 388 |
Current provisions relating to sales in current year | 1,556 | 2,565 |
Adjustments relating to prior years | 6 | 23 |
Payments relating to sales in current year | -1,370 | -2,165 |
Payments/returns relating to sales in prior years | -383 | -327 |
Ending balance | 293 | 484 |
Patient financial assistance | ' | ' |
Valuation Allowance [Line Items] | ' | ' |
Beginning balance | 90 | 165 |
Current provisions relating to sales in current year | 179 | 498 |
Adjustments relating to prior years | 1 | -38 |
Payments relating to sales in current year | -145 | -378 |
Payments/returns relating to sales in prior years | -16 | -157 |
Ending balance | 109 | 90 |
Government rebates and chargebacks | ' | ' |
Valuation Allowance [Line Items] | ' | ' |
Beginning balance | 1,634 | 565 |
Current provisions relating to sales in current year | 1,425 | 2,806 |
Adjustments relating to prior years | -6 | -79 |
Payments relating to sales in current year | -494 | -1,380 |
Payments/returns relating to sales in prior years | -902 | -278 |
Ending balance | 1,657 | 1,634 |
Returns | ' | ' |
Valuation Allowance [Line Items] | ' | ' |
Beginning balance | 323 | 551 |
Current provisions relating to sales in current year | 89 | 145 |
Adjustments relating to prior years | -18 | -141 |
Payments relating to sales in current year | 0 | 0 |
Payments/returns relating to sales in prior years | -53 | -232 |
Ending balance | $341 | $323 |
Significant_Transactions_Addit
Significant Transactions - Additional Information (Detail) (USD $) | 3 Months Ended | 6 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | 12 Months Ended | ||||||||||
Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | Dec. 31, 2013 | Jun. 30, 2013 | Jun. 30, 2013 | Dec. 31, 2013 | Dec. 31, 2010 | Mar. 31, 2013 | Mar. 31, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2014 | Dec. 31, 2013 | Jun. 30, 2014 | Dec. 31, 2013 | Dec. 31, 2013 | |
CMIC Co., Ltd, (CMIC) | CMIC Co., Ltd, (CMIC) | CMIC Co., Ltd, (CMIC) | CMIC Co., Ltd, (CMIC) | Sigma Tau | Sigma Tau | CVie Therapeutics | CVie Therapeutics | CVie Therapeutics | CVie Therapeutics | Novellus Plan | Novellus Plan | Novellus Plan | Novellus Plan | ||||||
Up-front Payment Arrangement | Contract Termination | Up-front Payment Arrangement | Up-front Payment Arrangement | Up-front Payment Arrangement | |||||||||||||||
Maximum | |||||||||||||||||||
Significant Transactions [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Collaboration arrangement payment | ' | ' | ' | ' | ' | ' | ' | ' | $4,000,000 | ' | ' | ' | ' | ' | $1,000,000 | ' | ' | $500,000 | ' |
Collaboration arrangement receivable | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 11,000,000 | ' | 800,000 | ' | ' | 5,200,000 |
Revenue | 19,585,000 | 11,336,000 | 33,702,000 | 23,376,000 | ' | 206,000 | 397,000 | ' | ' | ' | ' | 33,000 | 78,000 | 33,000 | ' | ' | ' | ' | ' |
Deferred revenue | ' | ' | ' | ' | ' | ' | ' | 2 | ' | ' | ' | 795,000 | ' | 795,000 | ' | ' | 800,000 | ' | ' |
Common stock, shares issued | 136,032,792 | ' | 136,032,792 | ' | 121,704,480 | ' | ' | ' | ' | ' | 271,665 | ' | ' | ' | ' | ' | ' | ' | ' |
Consideration contractually obligated to pay contingent upon future sales | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 500,000 | ' | ' | ' | ' | ' | ' | ' | ' |
Compensation received during the next ten years in relation to the license or supply of ecallantide | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 5,000,000 | ' | ' | ' | ' | ' | ' | ' | ' |
Reduction to development and license fee revenue | ' | ' | ' | ' | ' | ' | ' | ' | ' | 1,100,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Deferred revenue, revenue recognized | ' | ' | ' | ' | ' | ' | ' | ' | ' | $85,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Financial_Assets_Measured_at_F
Financial Assets Measured at Fair Value (Detail) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Financial Assets Measured at Fair Value [Line Items] | ' | ' |
Assets fair value disclosure Recurring | $180,847 | $98,865 |
Quoted Prices in Active Markets (Level 1) | ' | ' |
Financial Assets Measured at Fair Value [Line Items] | ' | ' |
Assets fair value disclosure Recurring | 23,159 | 55,569 |
Significant Other Observable Inputs (Level 2) | ' | ' |
Financial Assets Measured at Fair Value [Line Items] | ' | ' |
Assets fair value disclosure Recurring | 157,688 | 43,296 |
Money Market Funds | ' | ' |
Financial Assets Measured at Fair Value [Line Items] | ' | ' |
Assets fair value disclosure Recurring | 23,159 | 55,569 |
Money Market Funds | Quoted Prices in Active Markets (Level 1) | ' | ' |
Financial Assets Measured at Fair Value [Line Items] | ' | ' |
Assets fair value disclosure Recurring | 23,159 | 55,569 |
Money Market Funds | Significant Other Observable Inputs (Level 2) | ' | ' |
Financial Assets Measured at Fair Value [Line Items] | ' | ' |
Assets fair value disclosure Recurring | 0 | 0 |
Marketable debt securities | ' | ' |
Financial Assets Measured at Fair Value [Line Items] | ' | ' |
Assets fair value disclosure Recurring | 157,688 | 43,296 |
Marketable debt securities | Quoted Prices in Active Markets (Level 1) | ' | ' |
Financial Assets Measured at Fair Value [Line Items] | ' | ' |
Assets fair value disclosure Recurring | 0 | 0 |
Marketable debt securities | Significant Other Observable Inputs (Level 2) | ' | ' |
Financial Assets Measured at Fair Value [Line Items] | ' | ' |
Assets fair value disclosure Recurring | $157,688 | $43,296 |
Marketable_Securities_Detail
Marketable Securities (Detail) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Marketable Securities [Line Items] | ' | ' |
Amortized Cost | $157,595 | $43,293 |
Gross Unrealized Gains | 93 | 3 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 157,688 | 43,296 |
Due In One Year Or Less | ' | ' |
Marketable Securities [Line Items] | ' | ' |
Amortized Cost | 72,262 | 2,001 |
Gross Unrealized Gains | 53 | 1 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 72,315 | 2,002 |
Due After One Year Through Two Years | ' | ' |
Marketable Securities [Line Items] | ' | ' |
Amortized Cost | 85,333 | 41,292 |
Gross Unrealized Gains | 40 | 2 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | $85,373 | $41,294 |
Inventory_Additional_Informati
Inventory - Additional Information (Detail) (Other Noncurrent Assets, USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
In Millions, unless otherwise specified | ||
Other Noncurrent Assets | ' | ' |
Inventory [Line Items] | ' | ' |
Inventory classified as non-current | $4.60 | $5.50 |
Components_of_Inventory_Detail
Components of Inventory (Detail) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Inventory [Line Items] | ' | ' |
Raw Materials | $1,116 | $1,116 |
Work in Progress | 5,277 | 5,965 |
Finished Goods | 1,422 | 1,281 |
Total | $7,815 | $8,362 |
Components_of_Fixed_Assets_Det
Components of Fixed Assets (Detail) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | |||
Fixed Assets [Line Items] | ' | ' | ' |
Laboratory equipment | $3,932 | $3,932 | ' |
Furniture and office equipment | 849 | 815 | ' |
Software and computers | 2,968 | 2,958 | ' |
Leasehold improvements | 4,554 | 4,510 | 4,500 |
Total | 12,303 | 12,215 | ' |
Less: accumulated depreciation | -7,626 | -7,255 | ' |
Property, plant and equipment, Net | $4,677 | $4,960 | ' |
Fixed_Assets_Additional_Inform
Fixed Assets - Additional Information (Detail) (USD $) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | |
Fixed Assets [Line Items] | ' | ' | ' | ' |
Depreciation expense | $211,000 | $204,000 | $422,000 | $416,000 |
Components_of_Accounts_Payable
Components of Accounts Payable and Accrued Expenses (Detail) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Accounts Payable and Accrued Liabilities [Line Items] | ' | ' |
Accounts payable | $1,096 | $1,407 |
Accrued employee compensation and related taxes. | 3,921 | 4,609 |
Accrued legal | 664 | 456 |
Accounts payable and accrued expenses | 10,469 | 12,542 |
Research and Development Operations | ' | ' |
Accounts Payable and Accrued Liabilities [Line Items] | ' | ' |
Accrued liabilities | 1,498 | 1,778 |
Sales Allowances | ' | ' |
Accounts Payable and Accrued Liabilities [Line Items] | ' | ' |
Accrued liabilities | 1,948 | 1,918 |
Other Accrued Liabilities | ' | ' |
Accounts Payable and Accrued Liabilities [Line Items] | ' | ' |
Accrued liabilities | $1,342 | $2,374 |
LongTerm_Obligations_Additiona
Long-Term Obligations - Additional Information (Detail) (USD $) | 6 Months Ended | 12 Months Ended | 6 Months Ended | 6 Months Ended | 12 Months Ended | 12 Months Ended | 6 Months Ended | 12 Months Ended | |||||||||||||
Jun. 30, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2012 | Dec. 31, 2012 | Jun. 30, 2014 | Jun. 30, 2014 | Jun. 30, 2014 | Jun. 30, 2014 | Jun. 30, 2014 | Jun. 30, 2014 | Dec. 31, 2011 | Jun. 30, 2014 | Dec. 31, 2012 | Jun. 30, 2014 | Jun. 30, 2014 | Jun. 30, 2014 | Dec. 31, 2012 | Jun. 30, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
sqft | Maximum | Extended Term | Healthcare Royalty Partners | Healthcare Royalty Partners | Healthcare Royalty Partners | Healthcare Royalty Partners | Healthcare Royalty Partners | Healthcare Royalty Partners | Healthcare Royalty Partners | Healthcare Royalty Partners | Healthcare Royalty Partners | Healthcare Royalty Partners | Healthcare Royalty Partners | Healthcare Royalty Partners | Silicon Valley Bank | Silicon Valley Bank | Silicon Valley Bank | Silicon Valley Bank | |||
Tranche A and Tranche B Loans (Original Loan) | Tranche A and Tranche B Loans (Original Loan) | Tranche A and Tranche B Loans (Original Loan) | Tranche A and Tranche B Loans (Original Loan) | Refinanced Term Loan | Refinanced Term Loan | Refinanced Term Loan | Refinanced Term Loan | LFRP | LFRP | LFRP | Equipment lease | Equipment lease | Equipment lease | Equipment lease | |||||||
Phase 3 Trials | Group Two | Group Two | Tranche A Loan | Tranche A Loan | Tranche A Loan | Tranche B Loan | Tranche A and Tranche B Loans (Original Loan) | Tranche A Loan | Tranche B Loan | Negotiable Order of Withdrawal Accounts | |||||||||||
Minimum | Legal Fee | Second Affiliated | Second Affiliated | Second Affiliated | |||||||||||||||||
Debt Disclosure [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Secured Loan | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $22,800,000 | $61,700,000 | ' | ' | ' | ' |
Debt Instrument, Maturity, Month and Year | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 'August 2018 | ' | ' | ' | ' | ' | ' |
Interest on lease | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 13.00% | ' | ' | 12.00% | ' | ' | 6.00% | ' | ' | ' |
Debt instrument maturity date | ' | ' | ' | ' | ' | ' | 30-Sep-16 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Percentage of required payment for partial repayment of debt | ' | ' | ' | ' | ' | ' | 90.00% | 75.00% | 25.00% | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Annual net LFRP receipts amount used as a basis for repayment of loan | ' | ' | ' | ' | ' | ' | ' | 15,000,000 | ' | 15,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Principal amount of Loan | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 21,700,000 | 58,800,000 | ' | ' | ' | ' |
Proceed from unsecured loan | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 20,000,000 | ' | 57,600,000 | ' | ' | ' | ' | ' | ' | ' |
Effective interest rate | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 12.50% | ' | ' | ' | ' | ' | ' | ' | ' |
Decrease in note payable | 99,000 | 198,000 | ' | ' | ' | ' | ' | ' | ' | ' | 193,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Loan principal balance | ' | ' | ' | ' | ' | 84,500,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Fair value of note payable | 83,300,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Line of credit, maximum borrowing capacity | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 3,000,000 | ' | ' | ' |
Line of credit | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 698,000 | 931,000 | 1,400,000 |
Lease agreement term | ' | ' | '10 years | ' | '0 years | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | '3 years | ' | ' | ' |
Rentable square feet of office and laboratory facilities | ' | ' | 45,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Aggregate minimum lease commitment over payment lease term | ' | ' | 15,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Letter of Credit given to landlord to secure lease obligation | ' | ' | 1,100,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Tenant improvement allowance | ' | ' | ' | 2,600,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Capitalized leasehold improvements | $4,554,000 | $4,510,000 | $4,500,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Activity_under_Loan_Presented_
Activity under Loan Presented for Financial Reporting Purposes (Detail) (USD $) | 6 Months Ended | 12 Months Ended |
In Thousands, unless otherwise specified | Jun. 30, 2014 | Dec. 31, 2013 |
Debt Instrument [Line Items] | ' | ' |
Beginning balance | $81,516 | $78,061 |
Accretion of discount | 99 | 198 |
Loan activity: | ' | ' |
Interest Expense | 5,292 | 10,447 |
Payments applied to principal | 0 | 0 |
Payments applied to interest | -2,726 | -5,378 |
Accrued interest payable | -2,342 | -1,812 |
Ending balance | $81,839 | $81,516 |
Recovered_Sheet2
Stockholder's Equity and Stock-Based Compensation - Additional Information (Detail) (USD $) | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||
Mar. 31, 2014 | Feb. 28, 2014 | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | |
Stockholders Equity Note [Line Items] | ' | ' | ' | ' | ' | ' |
Common stock, shares issued | 9,200,000 | ' | ' | ' | ' | ' |
Common stock, per share | $9.25 | ' | ' | ' | ' | ' |
Proceed from offering | $79,700,000 | ' | ' | ' | ' | ' |
Number of preferred stock converted to common stock | ' | 41,418 | ' | ' | ' | ' |
Number of common stock issued upon conversion of preferred stock | ' | 4,141,800 | ' | ' | ' | ' |
Compensation expense | ' | ' | 2,011,000 | 884,000 | 3,251,000 | 2,828,000 |
Stock-based compensation expense | ' | ' | ' | ' | 3,251,000 | 2,828,000 |
Employee Stock Purchase Plans | ' | ' | ' | ' | ' | ' |
Stockholders Equity Note [Line Items] | ' | ' | ' | ' | ' | ' |
Percentage of price per share | ' | ' | ' | ' | 85.00% | ' |
Employee stock purchase plan offering period | ' | ' | ' | ' | '6 months | ' |
Contribution of employee in percentage | ' | ' | ' | ' | 10.00% | ' |
Contribution of employee in shares | ' | ' | 875 | ' | 875 | ' |
Compensation expense | ' | ' | 17,000 | 5,000 | 86,000 | 51,000 |
Number of shares purchased in period | ' | ' | ' | ' | 29,051 | 45,001 |
Number of shares reserved and available for issuance | ' | ' | 738,909 | ' | 738,909 | ' |
1995 Equity Incentive Plan (the Equity Plan) | ' | ' | ' | ' | ' | ' |
Stockholders Equity Note [Line Items] | ' | ' | ' | ' | ' | ' |
Number of shares available for future grants | ' | ' | 10,455,238 | ' | 10,455,238 | ' |
Compensation expense | ' | ' | 1,994,000 | 879,000 | 3,165,000 | 2,777,000 |
Stock Compensation Plan | ' | ' | ' | ' | ' | ' |
Stockholders Equity Note [Line Items] | ' | ' | ' | ' | ' | ' |
Stock based compensation capitalized into inventory | ' | ' | 19,000 | 3,000 | 23,000 | 7,000 |
Stock Compensation Plan | Former Executive Officer | ' | ' | ' | ' | ' | ' |
Stockholders Equity Note [Line Items] | ' | ' | ' | ' | ' | ' |
Stock-based compensation expense | ' | ' | ' | ' | ' | $1,100,000 |
Stock Options | 1995 Equity Incentive Plan (the Equity Plan) | ' | ' | ' | ' | ' | ' |
Stockholders Equity Note [Line Items] | ' | ' | ' | ' | ' | ' |
Vesting period | ' | ' | ' | ' | '48 months | ' |
Contractual life of option | ' | ' | ' | ' | '10 years | ' |
Restricted Stock Units (RSUs) | 1995 Equity Incentive Plan (the Equity Plan) | ' | ' | ' | ' | ' | ' |
Stockholders Equity Note [Line Items] | ' | ' | ' | ' | ' | ' |
Vesting period | ' | ' | ' | ' | '0 years | ' |
Stock_Options_Activity_Detail
Stock Options Activity (Detail) | 6 Months Ended |
Jun. 30, 2014 | |
Stock Options | ' |
Options | ' |
Beginning balance | 10,628,879 |
Granted/Awarded | 2,695,159 |
Options Exercised/Shares Issued | -855,584 |
Cancelled | -366,076 |
Ending balance | 12,102,378 |
Exercisable at end of year | 6,539,703 |
Restricted Stock Units (RSUs) | ' |
Shares | ' |
Beginning balance | 253,124 |
Granted/Awarded | 352,841 |
Options Exercised/Shares Issued | -101,877 |
Cancelled | -22,276 |
Ending balance | 481,812 |
Exercisable at end of year | 0 |
Stock_Compensation_Expense_Det
Stock 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 |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' | ' | ' |
Compensation expenses | $2,011 | $884 | $3,251 | $2,828 |
Research and Development | ' | ' | ' | ' |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' | ' | ' |
Allocation of stock-based compensation expense | 737 | 280 | 1,227 | 508 |
Selling, General and Administrative | ' | ' | ' | ' |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' | ' | ' |
Allocation of stock-based compensation expense | 1,274 | 604 | 2,024 | 2,320 |
Equity Incentive Plan | ' | ' | ' | ' |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' | ' | ' |
Compensation expenses | 1,994 | 879 | 3,165 | 2,777 |
Employee Stock Purchase Plan | ' | ' | ' | ' |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' | ' | ' |
Compensation expenses | $17 | $5 | $86 | $51 |
Income_Taxes_Additional_Inform
Income Taxes - Additional Information (Detail) (USD $) | 12 Months Ended |
In Millions, unless otherwise specified | Dec. 31, 2013 |
Income Taxes [Line Items] | ' |
Deferred tax asset, exercise of stock options | $1.80 |
Deferred tax assets valuation allowance | 213.9 |
Equity method investment, ownership percentage | 5.00% |
Federal Tax | ' |
Income Taxes [Line Items] | ' |
Federal research and experimentation and orphan drug credit carryforward | 56.8 |
Restricted NOLs | 67.2 |
Federal tax credits | 4.8 |
Federal tax net operating loss carryforward | 262 |
Stock Option | ' |
Income Taxes [Line Items] | ' |
Federal tax net operating loss carryforward | $8.20 |