Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2014 |
Accounting Policies [Abstract] | ' |
The Company | ' |
The Company |
BioCryst Pharmaceuticals, Inc. (the “Company”) is a biotechnology company that designs, optimizes and develops novel drugs that block key enzymes involved in the pathogenesis of diseases. The Company focuses on rare and infectious diseases in which unmet medical needs exist and that are aligned with its capabilities and expertise. The Company was incorporated in Delaware in 1986 and its headquarters is located in Durham, North Carolina. The Company integrates the disciplines of biology, crystallography, medicinal chemistry and computer modeling to discover and develop small molecule pharmaceuticals through the process known as structure-guided drug design. BioCryst has incurred losses and negative cash flows from operations since inception. |
Based on its current operating plans, the Company expects it has sufficient liquidity, with its existing cash and investments of $34,220, to continue its planned operations into the first quarter of 2015. The Company’s liquidity needs, and ability to address those needs, will largely be determined by the success of its product candidates and key development and regulatory events in the future. In order to continue its operations substantially beyond the first quarter of 2015 it will need to: (1) successfully secure or increase U.S. Government funding of its programs; (2) out-license rights to certain of its product candidates, pursuant to which the Company would receive cash milestones; (3) raise additional capital through equity or debt financings or from other sources; (4) obtain product candidate regulatory approvals, which would generate revenue and cash flow; (5) reduce spending on one or more research and development programs; and/or (6) restructure operations. The Company will continue to incur operating losses and negative cash flows until revenues reach a level sufficient to support ongoing operations. |
Basis of Presentation | ' |
Basis of Presentation |
Beginning in March 2011, the consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, JPR Royalty Sub LLC (“Royalty Sub”). Royalty Sub was formed in connection with a $30,000 financing transaction the Company completed on March 9, 2011. See Note 4, Royalty Monetization, for a further description of this transaction. All intercompany transactions and balances have been eliminated. |
The Company’s consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) for interim financial reporting and the instructions to Form 10-Q and do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. Such financial statements reflect all adjustments that are, in management’s opinion, necessary to present fairly, in all material respects, the Company’s consolidated financial position, results of operations, and cash flows. There were no adjustments other than normal recurring adjustments. |
These financial statements should be read in conjunction with the financial statements for the year ended December 31, 2013 and the notes thereto included in the Company’s 2013 Annual Report on Form 10-K. Interim operating results are not necessarily indicative of operating results for the full year. The balance sheet as of December 31, 2013 has been derived from the audited consolidated financial statements included in the Company’s most recent Annual Report on Form 10-K. |
Reclassifications | ' |
Reclassifications |
In the first quarter of 2014, the Company changed its classification of patent costs. This change resulted in $196 of patent expenses being reclassified from research and development expense to general and administrative expense for the three months ended March 31, 2013. This reclassification had no effect on previously reported total operating expenses or net loss amounts. |
Cash and Cash Equivalents | ' |
Cash and Cash Equivalents |
The Company generally considers cash equivalents to be all cash held in commercial checking accounts, money market accounts or investments in debt instruments with maturities of three months or less at the time of purchase. The carrying value of cash and cash equivalents approximates fair value due to the short-term nature of these items. |
Restricted Cash | ' |
Restricted Cash |
Restricted cash as of March 31, 2014 reflects $150 the Company is required to maintain in an interest bearing certificate of deposit to serve as collateral for a corporate credit card program. |
Investments | ' |
Investments |
The Company invests in high credit quality investments in accordance with its investment policy, which is designed to minimize the possibility of loss. The objective of the Company’s investment policy is to ensure the safety and preservation of invested funds, as well as maintaining liquidity sufficient to meet cash flow requirements. The Company places its excess cash with high credit quality financial institutions, commercial companies, and government agencies in order to limit the amount of its credit exposure. Per its policy, the Company is able to invest in marketable debt securities that may consist of U.S. Government and government agency securities, money market and mutual fund investments, municipal and corporate notes and bonds, commercial paper and asset or mortgage-backed securities, among others. The Company’s investment policy requires it to purchase high-quality marketable securities with a maximum individual maturity of three years and requires an average portfolio maturity of no more than 18 months. Some of the securities the Company invests in may have market risk. This means that a change in prevailing interest rates may cause the principal amount of the investment to fluctuate. To minimize this risk, the Company schedules its investments with maturities that coincide with expected cash flow needs, thus avoiding the need to redeem an investment prior to its maturity date. Accordingly, the Company does not believe it has a material exposure to interest rate risk arising from its investments. Generally, the Company’s investments are not collateralized. The Company has not realized any significant losses from its investments. |
The Company classifies all of its investments as available-for-sale. Unrealized gains and losses on investments are recognized in comprehensive income/(loss), unless an unrealized loss is considered to be other than temporary, in which case the unrealized loss is charged to operations. The Company periodically reviews its investments for other than temporary declines in fair value below cost basis and whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company believes the individual unrealized losses represent temporary declines primarily resulting from interest rate changes. Realized gains and losses are reflected in interest and other income in the Consolidated Statements of Comprehensive Loss and are determined using the specific identification method with transactions recorded on a settlement date basis. Investments with original maturities at date of purchase beyond three months and which mature at or less than 12 months from the balance sheet date are classified as current. Investments with a maturity beyond 12 months from the balance sheet date are classified as long-term. At March 31, 2014, the Company believes that the costs of its investments are recoverable in all material respects. |
The following tables summarize the fair value of the Company’s investments by type. The estimated fair value of the Company’s fixed income investments are classified as Level 2 in the fair value hierarchy as defined in U.S. GAAP. These fair values are obtained from independent pricing services which utilize Level 2 inputs. |
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| | March 31, 2014 | |
| | Amortized | | | Accrued | | | Gross | | | Gross | | | Estimated | |
Cost | Interest | Unrealized | Unrealized | Fair Value |
| | Gains | Losses | |
Obligations of U.S. Government and its agencies | | $ | 4,800 | | | $ | 1 | | | $ | — | | | $ | 1 | | | $ | 4,800 | |
Corporate debt securities | | | 6,045 | | | | 46 | | | | 2 | | | | 1 | | | | 6,092 | |
Commercial paper | | | 9,592 | | | | — | | | | 2 | | | | — | | | | 9,594 | |
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Total investments | | $ | 20,437 | | | $ | 47 | | | $ | 4 | | | $ | 2 | | | $ | 20,486 | |
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| | December 31, 2013 | |
| | Amortized | | | Accrued | | | Gross | | | Gross | | | Estimated | |
Cost | Interest | Unrealized | Unrealized | Fair Value |
| | Gains | Losses | |
Obligations of U.S. Government and its agencies | | $ | 4,899 | | | $ | 1 | | | $ | 1 | | | $ | — | | | $ | 4,901 | |
Corporate debt securities | | | 8,528 | | | | 47 | | | | 2 | | | | 1 | | | | 8,576 | |
Commercial paper | | | 5,994 | | | | — | | | | 2 | | | | — | | | | 5,996 | |
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Total investments | | $ | 19,421 | | | $ | 48 | | | $ | 5 | | | $ | 1 | | | $ | 19,473 | |
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The following table summarizes the scheduled maturity for the Company’s investments at March 31, 2014 and December 13, 2013. |
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| | 2014 | | | 2013 | | | | | | | | | | | | | |
Maturing in one year or less | | $ | 17,807 | | | $ | 16,891 | | | | | | | | | | | | | |
Maturing after one year through two years | | | 2,679 | | | | 2,582 | | | | | | | | | | | | | |
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Total investments | | $ | 20,486 | | | $ | 19,473 | | | | | | | | | | | | | |
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Receivables | ' |
Receivables |
Receivables are recorded for amounts due to the Company related to reimbursable research and development costs from the U.S. Department of Health and Human Services or royalty receivables from Shionogi & Co. Ltd. At March 31, 2014 and December 31, 2013, the Company had the following receivables. |
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| | March 31, 2014 | | | | | | | | | |
| | Billed | | | Unbilled | | | Total | | | | | | | | | |
U.S. Department of Health and Human Services | | $ | 195 | | | $ | 1,270 | | | $ | 1,465 | | | | | | | | | |
Shionogi & Co. Ltd. | | | 1,815 | | | | — | | | | 1,815 | | | | | | | | | |
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Total receivables | | $ | 2,010 | | | $ | 1,270 | | | $ | 3,280 | | | | | | | | | |
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| | December 31, 2013 | | | | | | | | | |
| | Billed | | | Unbilled | | | Total | | | | | | | | | |
U.S. Department of Health and Human Services | | $ | 90 | | | $ | 1,573 | | | $ | 1,663 | | | | | | | | | |
Shionogi & Co. Ltd. | | | 452 | | | | — | | | | 452 | | | | | | | | | |
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Total receivables | | $ | 542 | | | $ | 1,573 | | | $ | 2,115 | | | | | | | | | |
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Monthly invoices are submitted to the U.S. Department of Health and Human Services related to reimbursable research and development costs. The Company is also entitled to monthly reimbursement of indirect costs based on rates stipulated in the underlying contract. The Company’s calculations of its indirect cost rates are subject to audit by the federal government. |
Patents and Licenses | ' |
Patents and Licenses |
The Company seeks patent protection on internally developed processes and products. All patent related costs are expensed to general and administrative expenses when incurred as recoverability of such expenditures is uncertain. |
Accrued Expenses | ' |
Accrued Expenses |
The Company generally enters into contractual agreements with third-party vendors who provide research and development, manufacturing, and other services in the ordinary course of business. Some of these contracts are subject to milestone-based invoicing and services are completed over an extended period of time. The Company records liabilities under these contractual commitments when it determines an obligation has been incurred, regardless of the timing of the invoice. This process involves reviewing open contracts and purchase orders, communicating with applicable Company personnel to identify services that have been performed on its behalf and estimating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced or otherwise notified of actual cost. The majority of service providers invoice the Company monthly in arrears for services performed. The Company makes estimates of accrued expenses as of each balance sheet date in its financial statements based on the facts and circumstances. The Company periodically confirms the accuracy of its estimates with the service providers and makes adjustments if necessary. Examples of estimated accrued expenses include: |
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| • | | fees paid to Clinical Research Organizations (“CROs”) in connection with preclinical and toxicology studies and clinical trials; | | | | | | | | | | | | | | | | | |
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| • | | fees paid to investigative sites in connection with clinical trials; | | | | | | | | | | | | | | | | | |
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| • | | fees paid to contract manufacturers in connection with the production of our raw materials, drug substance and drug products; and | | | | | | | | | | | | | | | | | |
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| • | | professional fees. | | | | | | | | | | | | | | | | | |
The Company bases its expenses related to clinical trials on its estimates of the services received and efforts expended pursuant to contracts with multiple research institutions and clinical research organizations that conduct and manage clinical trials on the Company’s behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. Payments under some of these contracts depend on factors such as the successful enrollment of patients and the completion of clinical trial milestones. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, the Company will adjust the accrual accordingly. Accrued expenses as of March 31, 2014 and December 31, 2013 included $2,076 and $2,210, respectively, of research and development costs. |
Income Taxes | ' |
Income Taxes |
The liability method is used in the Company’s accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on differences between financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. |
Accumulated Other Comprehensive (Loss) Income | ' |
Accumulated Other Comprehensive (Loss) Income |
Accumulated other comprehensive (loss) income is comprised of unrealized gains and losses on investments available-for-sale and is disclosed as a separate component of stockholders’ equity. No reclassifications out of accumulated other comprehensive (loss) income were recorded during the three months ended March 31, 2014 and 2013. |
Revenue Recognition | ' |
Revenue Recognition |
The Company recognizes revenues from collaborative and other research and development arrangements and product sales. Revenue is realized or realizable and earned when all of the following criteria are met: (i) persuasive evidence of an arrangement exists; (ii) delivery has occurred or services have been rendered; (iii) the seller’s price to the buyer is fixed or determinable; and (iv) collectability is reasonably assured. |
Collaborative and Other Research and Development Arrangements and Royalties |
Revenue from license fees, royalty payments, event payments, and research and development fees are recognized as revenue when the earnings process is complete and the Company has no further continuing performance obligations or the Company has completed the performance obligations under the terms of the agreement. Fees received under licensing agreements that are related to future performance are deferred and recognized over an estimated period determined by management based on the terms of the agreement and the products licensed. In the event a license agreement contains multiple deliverables, the Company evaluates whether the deliverables are separate or combined units of accounting. Revisions to revenue or profit estimates as a result of changes in the estimated revenue period are recognized prospectively. |
Under certain of our license agreements, the Company receives royalty payments based upon our licensees’ net sales of covered products. The Company recognizes royalty revenues when it can reliably estimate such amounts and collectability is reasonably assured. |
Reimbursements received for direct out-of-pocket expenses related to research and development costs are recorded as revenue in the Consolidated Statements of Comprehensive Loss rather than as a reduction in expenses. Event payments are recognized as revenue upon the achievement of specified events if (1) the event is substantive in nature and the achievement of the event was not reasonably assured at the inception of the agreement and (2) the fees are non-refundable and non-creditable. Any event payments received prior to satisfying these criteria are recorded as deferred revenue. Under the Company’s contracts with the U.S. Department of Health and Human Services, (“BARDA/HHS”), and the National Institute of Allergy and Infectious Diseases (“NIAID/HHS”), revenue is recognized as reimbursable direct and indirect costs are incurred. |
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Product Sales |
Sales are recognized when there is persuasive evidence that an arrangement exists, title has passed, the price was fixed and determinable, and collectability is reasonably assured. Product sales are recognized net of estimated allowances, discounts, sales returns, chargebacks and rebates. |
The Company recorded the following revenues for the three months ended March 31, 2014 and 2013: |
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| | 2014 | | | 2013 | | | | | | | | | | | | | |
Royalty revenue | | $ | 1,821 | | | $ | 1,924 | | | | | | | | | | | | | |
Collaborative and other research and development revenues: | | | | | | | | | | | | | | | | | | | | |
U.S. Department of Health and Human Services | | | 1,341 | | | | 1,334 | | | | | | | | | | | | | |
Shionogi (Japan) | | | 296 | | | | 296 | | | | | | | | | | | | | |
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Total revenues | | $ | 3,458 | | | $ | 3,554 | | | | | | | | | | | | | |
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Collaborative and Other Research and Development Arrangements and Royalties | ' |
Collaborative and Other Research and Development Arrangements and Royalties |
Revenue from license fees, royalty payments, event payments, and research and development fees are recognized as revenue when the earnings process is complete and the Company has no further continuing performance obligations or the Company has completed the performance obligations under the terms of the agreement. Fees received under licensing agreements that are related to future performance are deferred and recognized over an estimated period determined by management based on the terms of the agreement and the products licensed. In the event a license agreement contains multiple deliverables, the Company evaluates whether the deliverables are separate or combined units of accounting. Revisions to revenue or profit estimates as a result of changes in the estimated revenue period are recognized prospectively. |
Under certain of our license agreements, the Company receives royalty payments based upon our licensees’ net sales of covered products. The Company recognizes royalty revenues when it can reliably estimate such amounts and collectability is reasonably assured. |
Reimbursements received for direct out-of-pocket expenses related to research and development costs are recorded as revenue in the Consolidated Statements of Comprehensive Loss rather than as a reduction in expenses. Event payments are recognized as revenue upon the achievement of specified events if (1) the event is substantive in nature and the achievement of the event was not reasonably assured at the inception of the agreement and (2) the fees are non-refundable and non-creditable. Any event payments received prior to satisfying these criteria are recorded as deferred revenue. Under the Company’s contracts with the U.S. Department of Health and Human Services, (“BARDA/HHS”), and the National Institute of Allergy and Infectious Diseases (“NIAID/HHS”), revenue is recognized as reimbursable direct and indirect costs are incurred. |
Product Sales | ' |
Product Sales |
Sales are recognized when there is persuasive evidence that an arrangement exists, title has passed, the price was fixed and determinable, and collectability is reasonably assured. Product sales are recognized net of estimated allowances, discounts, sales returns, chargebacks and rebates. |
The Company recorded the following revenues for the three months ended March 31, 2014 and 2013: |
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| | 2014 | | | 2013 | | | | | | | | | | | | | |
Royalty revenue | | $ | 1,821 | | | $ | 1,924 | | | | | | | | | | | | | |
Collaborative and other research and development revenues: | | | | | | | | | | | | | | | | | | | | |
U.S. Department of Health and Human Services | | | 1,341 | | | | 1,334 | | | | | | | | | | | | | |
Shionogi (Japan) | | | 296 | | | | 296 | | | | | | | | | | | | | |
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Total revenues | | $ | 3,458 | | | $ | 3,554 | | | | | | | | | | | | | |
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Research and Development Expenses | ' |
Research and Development Expenses |
The Company’s research and development costs are charged to expense when incurred. Research and development expenses include all direct and indirect development costs related to the development of the Company’s portfolio of product candidates. Advance payments for goods or services that will be used or rendered for future research and development activities are deferred and capitalized. Such amounts are recognized as expense when the related goods are delivered or the related services are performed. Research and development expenses include, among other items, personnel costs, including salaries and benefits, manufacturing costs, clinical, regulatory, and toxicology services performed by CROs, materials and supplies, and overhead allocations consisting of various administrative and facilities related costs. Most of the Company’s manufacturing and clinical and preclinical studies are performed by third-party CROs. Costs for studies performed by CROs are accrued by the Company over the service periods specified in the contracts and estimates are adjusted, if required, based upon the Company’s on-going review of the level of services actually performed. |
Additionally, the Company has license agreements with third parties, such as Albert Einstein College of Medicine of Yeshiva University (“AECOM”), Industrial Research, Ltd. (“IRL”), and the University of Alabama at Birmingham (“UAB”), which require fees related to sublicense agreements or maintenance fees. The Company expenses sublicense payments as incurred unless they are related to revenues that have been deferred, in which case the expenses are deferred and recognized over the related revenue recognition period. The Company expenses maintenance payments as incurred. |
Deferred collaboration expenses represent sub-license payments, paid to the Company’s academic partners upon receipt of consideration from various commercial partners, and other consideration paid to our academic partners for modification to existing license agreements. These deferred expenses would not have been incurred without receipt of such payments or modifications from the Company’s commercial partners and are being expensed in proportion to the related revenue being recognized. The Company believes that this accounting treatment appropriately matches expenses with the associated revenue. |
Stock-Based Compensation | ' |
Stock-Based Compensation |
All share-based payments, including grants of stock option awards and restricted stock awards, are recognized in the Company’s Consolidated Statements of Comprehensive Loss based on their fair values. The fair value of stock option awards is estimated using the Black-Scholes option pricing model. The fair value of restricted stock awards is based on the grant date closing price of the common stock. Stock-based compensation cost is recognized as expense on a straight-line basis over the requisite service period of the award. |
Interest Expense and Deferred Financing Costs | ' |
Interest Expense and Deferred Financing Costs |
Interest expense for the three months ended March 31, 2014 and 2013 was $1,242 and $1,180, respectively, and relates to the issuance of the PhaRMA Notes (defined in Note 4). Costs directly associated with the issuance of the PhaRMA Notes have been capitalized and are included in other non-current assets on the Consolidated Balance Sheets. These costs are being amortized to interest expense over the term of the PhaRMA Notes using the effective interest rate method. Amortization of deferred financing costs included in interest expense was $110 for each of the three months ended March 31, 2014 and 2013. |
Currency Hedge Agreement | ' |
Currency Hedge Agreement |
In connection with the issuance by Royalty Sub of the PhaRMA Notes, the Company entered into a Currency Hedge Agreement (defined in Note 4) to hedge certain risks associated with changes in the value of the Japanese yen relative to the U.S. dollar. The Currency Hedge Agreement does not qualify for hedge accounting treatment; therefore, mark-to-market adjustments are recognized in the Company’s Consolidated Statements of Comprehensive Loss. Cumulative mark-to-market adjustments for the three months ended March 31, 2014 and 2013 resulted in a loss of $1,526 and a gain of $1,957, respectively. Mark-to-market adjustments are determined by a third party pricing model that uses quoted prices in markets that are not actively traded and for which significant inputs are observable directly or indirectly, representing Level 2 in the fair value hierarchy as defined by U.S. GAAP. The Company is also required to post collateral in connection with the mark-to-market adjustments based on thresholds defined in the Currency Hedge Agreement. As of March 31, 2014, $1,530 of hedge collateral was posted under the agreement. No hedge collateral was posted under the agreement as of December 31, 2013. |
Net Loss Per Share | ' |
Net Loss Per Share |
Net loss per share is based upon the weighted average number of common shares outstanding during the period. Diluted loss per share is equivalent to basic net loss per share for all periods presented herein because common equivalent shares from unexercised stock options and common shares expected to be issued under the Company’s employee stock purchase plan were anti-dilutive. The calculation of diluted earnings per share for the three months ended March 31, 2014 and 2013 does not include 5,206 and 681, respectively, of such potential common shares, as their impact would be anti-dilutive. |
Use of Estimates | ' |
Use of Estimates |
The preparation of financial statements in conformity with U.S. GAAP requires the Company to make estimates and assumptions that affect the amounts reported in the financial statements. Actual results could differ from those estimates. |
Concentration of Market Risk | ' |
Concentration of Market Risk |
The reimbursement of peramivir and BCX4430 development expenses is a significant source of the Company’s revenue and one which has an underlying cash flow stream. This revenue and cash flow is earned under cost-plus-fixed-fee contracts with BARDA/HHS and NIAID/HHS, respectively. The Company relies on BARDA/HHS and NIAID/HHS to reimburse predominantly all of the development costs for its peramivir and BCX4430 programs, respectively. Accordingly, reimbursement of these expenses represents a significant portion of the Company’s collaborative and other research and development revenues. The completion and/or termination of these programs/collaborations could negatively impact the Company’s future Consolidated Statements of Comprehensive Loss and Cash Flows. In addition, the Company also recognizes royalty revenue from the net sales of RAPIACTA®; however, the underlying cash flow from these royalty payments goes directly to pay the interest, and then the principal, on the Company’s non-recourse notes payable. Payment of the interest and the ultimate repayment of principal of these notes will be entirely funded by future royalty payments derived from net sales of RAPIACTA®. At March 31, 2014, there was a significant underpayment of interest on the PhaRMA Notes, which if unpaid at September 1, 2014, will constitute an event of default under the PhaRMA Notes. If an event of default were to occur under the PhaRMA Notes, the holders of the PhaRMA Notes may be able to foreclose on the collateral securing the PhaRMA Notes and our equity interest in Royalty Sub and exercise other remedies available to them under the indenture in respect of the PhaRMA Notes. In such event, we may not realize the benefit of future royalty payments that might otherwise accrue to us following repayment of the PhaRMA Notes and we might otherwise be adversely affected. The Company’s drug development activities are performed by a limited group of third party vendors. If any of these vendors were unable to perform their services, this could significantly impact the Company’s ability to complete its drug development activities. |
Credit Risk | ' |
Credit Risk |
Cash equivalents and investments are financial instruments which potentially subject the Company to concentration of risk to the extent recorded on the Consolidated Balance Sheets. The Company deposits excess cash with major financial institutions in the United States. Balances may exceed the amount of insurance provided on such deposits. The Company believes it has established guidelines for investment of its excess cash relative to diversification and maturities that maintain safety and liquidity. To minimize the exposure due to adverse shifts in interest rates, the Company maintains a portfolio of investments with an average maturity of approximately 24 months or less. The majority of the Company’s receivables are due from the U.S. Government, for which there is no assumed credit risk. |
Recent Accounting Pronouncements | ' |
Recent Accounting Pronouncements |
There have been no recent accounting pronouncements or changes in accounting pronouncements since the recent accounting pronouncements described in the Company’s 2013 Annual Report on Form 10-K that are of significance to the Company. |