Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2014 |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation |
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Use of Estimates |
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The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America (GAAP) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. |
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Principles of Consolidation |
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Synageva’s consolidated financial statements include the accounts of Synageva and its wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. |
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Reverse Merger |
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On November 2, 2011, Trimeris, Inc., a Delaware corporation (Trimeris), closed a merger transaction (the Reverse Merger) with Synageva BioPharma Corp., a privately held Delaware corporation (Private Synageva), pursuant to an Agreement and Plan of Merger and Reorganization, dated as of June 13, 2011 (the Merger Agreement), by and among Trimeris, Private Synageva and Tesla Merger Sub, Inc., a wholly owned subsidiary of Trimeris (Merger Sub). Pursuant to the Merger Agreement, Private Synageva became a wholly owned subsidiary of Trimeris through a merger of Merger Sub with and into Private Synageva, and the former stockholders of Private Synageva received shares of Trimeris that constituted a majority of the outstanding shares of Trimeris. In connection with the Reverse Merger, Trimeris changed its name to Synageva BioPharma Corp. |
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The Reverse Merger was accounted for as a reverse acquisition under which Private Synageva was considered the acquirer of Trimeris. |
Use of Estimates | Use of Estimates |
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The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America (GAAP) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. |
Principles of Consolidation | Principles of Consolidation |
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Synageva’s consolidated financial statements include the accounts of Synageva and its wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. |
Reverse Merger | Reverse Merger |
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On November 2, 2011, Trimeris, Inc., a Delaware corporation (Trimeris), closed a merger transaction (the Reverse Merger) with Synageva BioPharma Corp., a privately held Delaware corporation (Private Synageva), pursuant to an Agreement and Plan of Merger and Reorganization, dated as of June 13, 2011 (the Merger Agreement), by and among Trimeris, Private Synageva and Tesla Merger Sub, Inc., a wholly owned subsidiary of Trimeris (Merger Sub). Pursuant to the Merger Agreement, Private Synageva became a wholly owned subsidiary of Trimeris through a merger of Merger Sub with and into Private Synageva, and the former stockholders of Private Synageva received shares of Trimeris that constituted a majority of the outstanding shares of Trimeris. In connection with the Reverse Merger, Trimeris changed its name to Synageva BioPharma Corp. |
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The Reverse Merger was accounted for as a reverse acquisition under which Private Synageva was considered the acquirer of Trimeris. |
Cash and Cash Equivalents | Cash and Cash Equivalents |
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The Company considers all highly liquid investments with a remaining maturity at the date of purchase of 90 days or less to be cash equivalents. At December 31, 2014 and 2013, substantially all cash equivalents were U.S. treasury bills and amounts held in money market accounts at commercial banks. |
Investments | Investments |
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All of the Company’s investments were classified as available-for-sale at December 31, 2014 and 2013. The principal amounts of short-term investments are summarized in the tables below: |
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| | Less Than 12 Months to Maturity | |
| | Amortized | | | Unrealized | | | Unrealized | | | Fair Value | |
Cost | Gains | (Losses) |
Balance at December 31, 2014: | | | | | | | | | | | | | | | | |
U.S. Treasury securities | | $ | 364,352 | | | $ | — | | | $ | (97 | ) | | $ | 364,255 | |
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Total | | $ | 364,352 | | | $ | — | | | $ | (97 | ) | | $ | 364,255 | |
Balance at December 31, 2013: | | | | | | | | | | | | | | | | |
U.S. Treasury securities | | $ | 346,618 | | | $ | — | | | $ | (22 | ) | | $ | 346,596 | |
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Total | | $ | 346,618 | | | $ | — | | | $ | (22 | ) | | $ | 346,596 | |
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The following table presents information about the Company’s financial assets and liabilities measured at fair value on a recurring basis as of December 31, 2014: |
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| | December 31, | | | Quoted | | | Significant | | | Significant | |
2014 | Price in | Other | Unobservable |
| Active | Observable | Inputs |
| Markets | Inputs | (Level 3) |
| (Level 1) | (Level 2) | |
Assets | | | | | | | | | | | | | | | | |
Cash equivalents | | | | | | | | | | | | | | | | |
Money market fund | | $ | 71,226 | | | $ | — | | | $ | 71,226 | | | $ | — | |
US treasury securities | | | — | | | | — | | | | — | | | | — | |
Marketable securities | | | | | | | | | | | | | | | | |
US treasury securities | | | 364,255 | | | | — | | | | 364,255 | | | | — | |
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Total | | $ | 435,481 | | | $ | — | | | $ | 435,481 | | | $ | — | |
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Level 1 inputs are quoted prices in active markets for identical assets or liabilities and consist of cash on deposit. Items classified as Level 2 within the valuation hierarchy consist of U.S. government-related debt securities and money market funds. We estimate the fair values of these marketable securities by taking into consideration valuations obtained from third-party pricing sources. These pricing sources utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include market pricing based on real-time trade data for the same or similar securities, issuer credit spreads, benchmark yields, and other observable inputs. We validate the prices provided by our third-party pricing sources by understanding the models used, obtaining market values from other pricing sources and analyzing pricing data in certain instances. |
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The following table presents information about the Company’s financial assets and liabilities measured at fair value on a recurring basis as of December 31, 2013: |
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| | December 31, | | | Quoted | | | Significant | | | Significant | |
2013 | Price in | Other | Unobservable |
| Active | Observable | Inputs |
| Markets | Inputs | (Level 3) |
| (Level 1) | (Level 2) | |
Assets | | | | | | | | | | | | | | | | |
Cash equivalents | | | | | | | | | | | | | | | | |
Money market fund | | $ | 27,899 | | | $ | 27,899 | | | $ | — | | | $ | — | |
US treasury securities | | | 21,021 | | | | — | | | | 21,021 | | | | — | |
Marketable securities | | | | | | | | | | | | | | | | |
US treasury securities | | | 346,596 | | | | — | | | | 346,596 | | | | — | |
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Total | | $ | 395,516 | | | $ | 27,899 | | | $ | 367,617 | | | $ | — | |
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Impairment of Other Long-Lived Assets | Impairment of Other Long-Lived Assets |
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The Company continually evaluates whether events or circumstances have occurred that indicate that the estimated remaining useful life of long-lived assets and intangible assets may warrant revision or if events or circumstances indicate that the carrying value of these assets may be impaired. To assess whether assets have been impaired, the estimated undiscounted future cash flows for the estimated remaining useful life of the assets are compared to the carrying value. To the extent that the future cash flows are less than the carrying value, the assets are written down to the estimated fair value, based on the discounted cash flows of the asset. |
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Other-than-Temporary Impairment |
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The Company assesses other-than-temporary impairment in equity method investments in accordance with ASC 323-10, “Investments—Equity Method and Joint Ventures.” Equity method investments are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an investment might not be recoverable. To evaluate potential other-than-temporary impairments, the Company: i) determines when an investment is considered impaired; ii) evaluates whether the impairment is other-than-temporary, and iii) measures and recognizes the other-than-temporary impairment. Once an equity method investment is deemed to be other-than-temporarily impaired, it is recorded at its fair value. An impairment charge is measured as the difference between the carrying amount of the asset and the fair value. As part of the Company’s impairment assessment at year end, it evaluated the strategic equity method investment made in 2014 (described below). |
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Equity Method Investment |
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During the second quarter of 2014, Synageva made a strategic investment in a privately-held biotechnology company focused on the development of targeted treatments for liver diseases. Under the terms of the agreement, Synageva made an initial $5.0 million non-refundable payment, which in part was used to fund preclinical development through proof of concept for an undisclosed initial program. The Company has the option to fund further preclinical development, and, upon achievement of certain development milestones for the initial program, the option to acquire the company for $28.5 million plus additional payments based on achievement of development, regulatory and revenue milestones. |
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Synageva determined that this investment represents a variable interest in a variable interest entity (VIE). Variable interests in VIEs are investments or other interests that absorb portions of a VIEs expected losses or receive portions of the entity’s expected returns. According to the accounting guidance, a variable interest holder must evaluate whether it is the VIE’s primary beneficiary, to determine whether consolidation accounting is required. Only one entity can be the primary beneficiary. The Company evaluated the applicable criteria and determined that, while it may be in a position to benefit most significantly from the investment, it does not have the power to direct the activities that most significantly impact the economic performance of the VIE. The Company believes those powers reside with the management of the VIE. Therefore, the Company is not required to consolidate the VIE in its financial statements at this time. The consolidation assessment could change if significant changes to the relationship occur in the future, such as if the option to acquire is exercised. The Company also evaluated whether its involvement in the VIE provides it with “significant influence” over the investment, which determines whether to account for the investment under the equity or cost methods. The Company’s ownership percentage at the onset of the arrangement was approximately 12%, which is below the 20% presumed percentage of significant influence. However, because of the continued involvement in reviewing the progress of the development program, the Company determined that it does have a significant level of influence, as defined by the accounting guidance. |
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The initial $5.0 million investment was comprised of a $1.5 million upfront cash payment and $3.5 million cash payment for Series A-1 Preferred Stock. In addition, the Company capitalized $0.6 million of direct costs associated with the investment. Additional funding of $2.0 million was made during 2014 for additional Series A-1 Preferred Stock. The $6.1 million equity method investment was adjusted based on the Company’s pro-rata share of the investment’s net income or net loss and totaled $5.5 million after accounting for Synageva’s pro-rata share of the investments net loss throughout the year. |
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At year end, the Company evaluated the strategic equity method investment and determined that the asset was other-than-temporarily impaired, and that the estimated fair value of the investment was less than the carrying value of the investment. The Company determined the fair value of the asset to be $2.0 million, based on a discounted cash flows analysis of the asset. As such, the Company wrote down the asset to its fair value, resulting in incremental expense of $3.5 million for the year ended December 31, 2014. As of December 31, 2014, the equity method investment totaled $2.0 million and is included in other assets in our accompanying consolidated balance sheets. The Company has recorded approximately $3.5 million of research and development expense related to the impairment, and $0.6 million of “other expense” related to its pro rata portion of the VIEs operating losses since the investment was made. The remaining $2.0 million balance for the equity method investment represents the Company’s current maximum exposure to loss related to the asset. |
Other-than-Temporary Impairment | Other-than-Temporary Impairment |
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The Company assesses other-than-temporary impairment in equity method investments in accordance with ASC 323-10, “Investments—Equity Method and Joint Ventures.” Equity method investments are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an investment might not be recoverable. To evaluate potential other-than-temporary impairments, the Company: i) determines when an investment is considered impaired; ii) evaluates whether the impairment is other-than-temporary, and iii) measures and recognizes the other-than-temporary impairment. Once an equity method investment is deemed to be other-than-temporarily impaired, it is recorded at its fair value. An impairment charge is measured as the difference between the carrying amount of the asset and the fair value. As part of the Company’s impairment assessment at year end, it evaluated the strategic equity method investment made in 2014 (described below). |
Equity Method Investment | Equity Method Investment |
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During the second quarter of 2014, Synageva made a strategic investment in a privately-held biotechnology company focused on the development of targeted treatments for liver diseases. Under the terms of the agreement, Synageva made an initial $5.0 million non-refundable payment, which in part was used to fund preclinical development through proof of concept for an undisclosed initial program. The Company has the option to fund further preclinical development, and, upon achievement of certain development milestones for the initial program, the option to acquire the company for $28.5 million plus additional payments based on achievement of development, regulatory and revenue milestones. |
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Synageva determined that this investment represents a variable interest in a variable interest entity (VIE). Variable interests in VIEs are investments or other interests that absorb portions of a VIEs expected losses or receive portions of the entity’s expected returns. According to the accounting guidance, a variable interest holder must evaluate whether it is the VIE’s primary beneficiary, to determine whether consolidation accounting is required. Only one entity can be the primary beneficiary. The Company evaluated the applicable criteria and determined that, while it may be in a position to benefit most significantly from the investment, it does not have the power to direct the activities that most significantly impact the economic performance of the VIE. The Company believes those powers reside with the management of the VIE. Therefore, the Company is not required to consolidate the VIE in its financial statements at this time. The consolidation assessment could change if significant changes to the relationship occur in the future, such as if the option to acquire is exercised. The Company also evaluated whether its involvement in the VIE provides it with “significant influence” over the investment, which determines whether to account for the investment under the equity or cost methods. The Company’s ownership percentage at the onset of the arrangement was approximately 12%, which is below the 20% presumed percentage of significant influence. However, because of the continued involvement in reviewing the progress of the development program, the Company determined that it does have a significant level of influence, as defined by the accounting guidance. |
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The initial $5.0 million investment was comprised of a $1.5 million upfront cash payment and $3.5 million cash payment for Series A-1 Preferred Stock. In addition, the Company capitalized $0.6 million of direct costs associated with the investment. Additional funding of $2.0 million was made during 2014 for additional Series A-1 Preferred Stock. The $6.1 million equity method investment was adjusted based on the Company’s pro-rata share of the investment’s net income or net loss and totaled $5.5 million after accounting for Synageva’s pro-rata share of the investments net loss throughout the year. |
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At year end, the Company evaluated the strategic equity method investment and determined that the asset was other-than-temporarily impaired, and that the estimated fair value of the investment was less than the carrying value of the investment. The Company determined the fair value of the asset to be $2.0 million, based on a discounted cash flows analysis of the asset. As such, the Company wrote down the asset to its fair value, resulting in incremental expense of $3.5 million for the year ended December 31, 2014. As of December 31, 2014, the equity method investment totaled $2.0 million and is included in other assets in our accompanying consolidated balance sheets. The Company has recorded approximately $3.5 million of research and development expense related to the impairment, and $0.6 million of “other expense” related to its pro rata portion of the VIEs operating losses since the investment was made. The remaining $2.0 million balance for the equity method investment represents the Company’s current maximum exposure to loss related to the asset. |
Amortization of Developed Technology | Amortization of Developed Technology |
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The Company provides for amortization of developed technology, computed using an accelerated method based on the undiscounted cash flows received from the FUZEON royalty stream, in proportion to the estimated total undiscounted cash flows, as discussed in further in Note 5, “Goodwill and Intangible Assets, net”. |
Goodwill | Goodwill |
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The difference between the purchase price and the fair value of assets acquired and liabilities assumed in a business combination is allocated to goodwill. Goodwill is not amortized; however, it is required to be tested for impairment annually. Furthermore, testing for impairment is required on an interim basis if an event or circumstance indicates that it is more likely than not an impairment loss has been incurred. An impairment loss would be recognized to the extent that the carrying amount of goodwill exceeds its implied fair value. Absent an event that indicates a specific impairment may exist, the Company has selected December 31 as the date for performing the annual goodwill impairment test. |
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The Company adopted ASU No. 2011-08, Intangibles-Goodwill and Other (Topic 350): Testing Goodwill for Impairment, during fiscal 2012, which allows companies to perform a simplified goodwill impairment test. Entities are no longer required to calculate the fair value of the reporting unit unless the qualitative factors indicate that it is more likely than not that a reporting unit’s fair value is less than its carrying amount. We evaluated our goodwill using the simplified approach, and our goodwill was not impaired as of December 31, 2014. |
Revenue Recognition | Revenue Recognition |
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The Company’s business strategy may include entering into collaborative agreements with biotechnology and pharmaceutical companies. Revenue under collaborations may include the receipt of non-refundable license fees, payments based on achievement of development objectives, reimbursement of research and development costs and royalties on product sales. |
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The Company recognizes revenue when all of the following criteria are met: persuasive evidence of an arrangement exists, services are performed or products are delivered, the fee is fixed and determinable, and collection is reasonably assured. Determination of whether persuasive evidence exists and whether delivery has occurred or services have been rendered are based on management’s judgment regarding the fixed nature of the fee charged for deliverables and the collectability of those fees. Should changes in conditions cause management to determine these criteria are not met for future transactions, revenue recognized could be adversely affected. |
Collaboration and License Revenue | Collaboration and License Revenue |
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The Company recognizes revenue related to collaboration and license agreements in accordance with the provisions of ASC Topics 605-25 “Revenue Recognition—Multiple Element Arrangements” (ASC Topic 605-25). The Company determines the selling price of a deliverable using the hierarchy as prescribed in ASC Topic 605-25 based on VSOE, third party evidence “TPE,” or BESP. VSOE is based on the price charged when the element sold separately and is the price actually charged for that deliverable. TPE is determined based on third party evidence for a similar deliverable when sold separately and BESP is the price which the Company would transact a sale if the elements of the collaboration and license agreements were sold on a stand-alone basis. The Company evaluates the above noted hierarchy when determining the fair value of a deliverable. The process for determining VSOE, TPE, or BESP involves significant judgment on the part of the Company and can include considerations of multiple factors such as estimated direct expenses and other costs and available data. ASC 605-25 is effective prospectively for new arrangements or upon material modification of existing arrangements. |
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The Company evaluates all deliverables within an arrangement to determine whether or not they provided value on a stand-alone basis. Based on this evaluation, the deliverables are separated into units of accounting. The arrangement consideration that is fixed and determinable at the inception of the arrangement is allocated to the separate units of accounting based on the estimated selling price. The Company may exercise significant judgment in determining whether a deliverable is a separate unit of accounting as well as in estimating the selling prices of such units of accounting. |
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Whenever the Company determines that an arrangement should be accounted for as a single unit of accounting, it must determine the period over which the performance obligations will be performed and revenue will be recognized. Revenue will be recognized using either a proportional performance or straight-line method. The Company recognizes revenue using the proportional performance method provided that the Company can reasonably estimate the level of effort required to complete its performance obligations under an arrangement and such performance obligations are provided on a best-efforts basis. Direct labor hours or full-time equivalents are typically used as the measure of performance. Revenue recognized under the relative performance method would be determined by multiplying the total payments under the contract, excluding royalties and payments contingent upon achievement of substantive milestones, by the ratio of level of effort incurred to date to estimated total level of effort required to complete the Company’s performance obligations under the arrangement. Revenue is limited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined using the relative performance method, as of each reporting period. |
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Significant management judgment is required in determining the level of effort required under an arrangement and the period over which the Company is expected to complete its performance obligations under an arrangement |
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The Company applies the guidance pursuant to ASU No. 2010-17, Revenue Recognition—Milestone Method, for all sales-based, commercial and research and development milestones achieved. Under the milestone method, a payment that is contingent upon the achievement of a substantive milestone is recognized in its entirety in the period in which the milestone is achieved. A milestone is an event (i) that can be achieved based in whole or in part on either our performance or on the occurrence of a specific outcome resulting from our performance, (ii) for which there is substantive uncertainty at the date the arrangement is entered into that the event will be achieved and (iii) that would result in additional payments being due. The determination that a milestone is substantive is subject to considerable judgment and is made at the inception of the arrangement. Milestones are considered substantive when the consideration earned from the achievement of the milestone is (i) commensurate with either the Company’s performance to achieve the milestone or the enhancement of value of the item delivered as a result of a specific outcome resulting from our performance to achieve the milestone, (ii) relates solely to past performance and (iii) is reasonable relative to all deliverables and payment terms in the arrangement. The adoption of this standard in fiscal 2011 has not impacted our financial position or results of operations. |
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See Note 9, “License Agreements and Collaborations,” for additional information on specific arrangements. Collaboration and license revenue totaled approximately $0.5 million, $6.3 million and $7.9 million for the years ended December 31, 2014, 2013 and 2012, respectively. The Company’s collaboration with Mitsbushi Tanabe was completed in 2013. |
Royalty Revenue | Royalty Revenue |
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Royalty revenues are recognized in the period earned, based on contract terms when reported sales are reliably measurable and collectability is reasonably assured. Following the merger with Trimeris, we received royalties due to the Development and License Agreement with Roche (the “Roche License Agreement”). As part of the Roche License Agreement, Roche has an exclusive license to manufacture and sell FUZEON worldwide and the Company receives royalty payments equal to 16% of worldwide net sales of FUZEON occurring from and after January 1, 2011. Under the Roche License Agreement, Roche may deduct from its royalty payments to us 50% of any royalties paid to third parties which are reasonably required to allow Roche to sell FUZEON in a given country, including royalties paid to Novartis Vaccines and Diagnostics, Inc. (Novartis).” To calculate the royalty revenue paid to Synageva, a 5.5% distribution charge is deducted from Roche’s reported net sales, and Synageva receives a 16% royalty on the adjusted net sales amount. Revenue from royalties totaled $6.0 million, $7.0 million, and $7.0 million for the year ended December 31, 2014, 2013 and 2012, respectively. These royalties represent the royalty payment earned from Roche based on total worldwide net sales of FUZEON since the closing of the Reverse Merger in November 2011. |
Reimbursement of Costs | Reimbursement of Costs |
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Reimbursement of research and development costs by third party collaborators is recognized as revenue provided the Company has determined that it is acting primarily as a principal in the transaction according to the provisions outlined in the Financial Accounting Standards Board (FASB) Codification Topic 605-45, Revenue Recognition, Principal Agent Considerations, the amounts are determinable and collection of the related receivable is reasonably assured. |
Deferred Revenue | Deferred Revenue |
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Amounts received prior to satisfying the above revenue recognition criteria are recorded as deferred revenue in the accompanying consolidated balance sheets. Amounts not expected to be recognized within twelve months from the balance sheet date would be classified as long-term deferred revenue. |
Research and Development | Research and Development |
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Research and development expenses primarily consist of internal personnel expense for discovery research, pre-clinical and clinical operations, manufacturing development, medical affairs and regulatory functions as well as fees for, clinical and non-clinical studies, materials and supplies, facilities, depreciation, third-party costs for contracted services, manufacturing process improvement and testing costs, and other research and development related costs. Clinical development and manufacturing costs are a significant component of our research and development expenses. We contract with third parties that perform various clinical trial activities and outsourced manufacturing activities on our behalf in the ongoing development of our product candidates. The financial terms of these contracts are subject to negotiations and may vary from contract to contract and may result in uneven payment flow. Research and development costs are expensed as incurred if no planned alternative future use exists for the technology and if the payment is not payment for future services. The Company defers and capitalizes its nonrefundable advance payments that are for research and development activities until the related goods are delivered or the related services are performed. |
Segment Reporting | Segment Reporting |
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The Company is managed and operated as one business, focused on the discovery, development, and commercialization of therapeutic products for patients with rare diseases for which there is a high unmet medical need. The entire business is managed by a single management team with reporting to the chief executive officer. The Company does not operate separate lines of business or separate business entities with respect to its products or product candidates. Accordingly, the Company does not prepare discrete financial information with respect to separate product areas or by location and only has one reportable segment. |
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Legal, Intellectual Property ("IP") and Patent Costs | Legal, Intellectual Property (IP) and Patent Costs |
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The Company accrues estimated liabilities for loss contingencies when it is probable that a liability has been incurred and the amount of the claim assessment or damages can be reasonably estimated. Synageva expenses legal fees, IP-related and patent costs as they are incurred. |
Income Taxes | Income Taxes |
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Deferred income taxes are provided for the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes and operating loss carryforwards and credits. Valuation allowances are recorded to reduce the net deferred tax assets to amounts the Company believes are more-likely-than-not to be realized. |
Stock-Based Compensation | Stock-Based Compensation |
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The Company’s share-based compensation awards to employees, including grants of employee stock options, are valued at fair value on the date of grant, and are expensed over the requisite service period. The requisite service period is the period during which an employee is required to provide service in exchange for an award, which generally is the vesting period. |
Concentration of Credit Risk and Other Risks and Uncertainties | Concentration of Credit Risk and Other Risks and Uncertainties |
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Financial instruments that potentially subject the Company to credit risk consist principally of cash, cash equivalents and U.S. treasury securities. The Company places its cash and cash equivalents in bank deposits, money market funds, and U.S. treasury bills which are maintained at several financial institutions. Deposits in these institutions may exceed the amount of insurance provided on such deposits. Management believes it has established guidelines relative to credit quality, diversification and maturities that maintain security and liquidity. |
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The Company is subject to risks and uncertainties common to the biotechnology industry. Such risks and uncertainties include, but are not limited to: (a) results from current and planned clinical trials, (b) scientific data collected on the Company’s technologies currently in preclinical research and development, (c) decisions made by the FDA or other regulatory bodies with respect to the initiation of human clinical trials, (d) decisions made by the FDA or other regulatory bodies with respect to approval and commercial sale of any of the Company’s proposed products, (e) the commercial acceptance of any products approved for sale and the ability of the Company to manufacture, distribute and sell for a profit any products approved for sale, (f) the Company’s ability to obtain the necessary patents and proprietary rights to effectively protect its technologies, (g) the outcome of any collaborations or alliances entered into by the Company in the future with pharmaceutical or other biotechnology companies, (h) dependence on key personnel, (i) competition with better capitalized companies and (j) ability to raise additional funds. |
Basic and Diluted Net Loss per Common Share | Basic and Diluted Net Loss per Common Share |
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Basic net loss per common share has been computed by dividing net loss by the weighted average number of shares outstanding during the period. Diluted net income per share, if applicable, has been computed by dividing diluted net income by the diluted number of shares outstanding during the period. Except where the result would be antidilutive to loss from continuing operations, diluted net loss per share has been computed assuming the conversion of convertible obligations and the elimination of the related interest expense, the exercise of stock options and warrants, as well as their related income tax effects. |
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The following table sets forth the computation of basic and diluted net loss per common share: |
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| | Years Ended December 31, | | | | | |
| | 2014 | | | 2013 | | | 2012 | | | | | |
Numerator: | | | | | | | | | | | | | | | | |
Net loss | | $ | (192,648 | ) | | $ | (95,450 | ) | | $ | (42,949 | ) | | | | |
Denominator | | | | | | | | | | | | | | | | |
Weighted average common shares | | | | | | | | | | | | | | | | |
Denominator for basic calculation | | | 32,719 | | | | 28,087 | | | | 22,579 | | | | | |
Denominator for diluted calculation | | | 32,719 | | | | 28,087 | | | | 22,579 | | | | | |
Net loss per share: | | | | | | | | | | | | | | | | |
Basic | | $ | (5.89 | ) | | $ | (3.40 | ) | | $ | (1.90 | ) | | | | |
Diluted | | $ | (5.89 | ) | | $ | (3.40 | ) | | $ | (1.90 | ) | | | | |
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The Company’s potential dilutive stock options have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted-average common stock outstanding used to calculate both basic and diluted net loss per share are the same. The following shares of potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding as the effect of including such securities would be antidilutive: |
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| | As of December 31, | | | | | |
| | 2014 | | | 2013 | | | 2012 | | | | | |
Common stock equivalents | | | 3,286 | | | | 2,710 | | | | 2,529 | | | | | |
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Recently Issued and Proposed Accounting Pronouncements | Recently Issued and Proposed Accounting Pronouncements |
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In August 2014, the FASB issued Accounting Standards Update No. 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (ASU 2014-15). ASU 2014-15 requires management to assess an entity’s ability to continue as a going concern, and to provide related footnote disclosures in certain circumstances. The standard is effective for public entities for annual and interim periods beginning after December 15, 2016, with early adoption permitted. We are currently evaluating the provisions of ASU 2014-15 and assessing the impact, if any, it may have on our financial position, results of operations or cash flows. |
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In May 2014, the FASB and the International Accounting Standards Board (IASB) jointly issued Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers (ASU 2014-09), a comprehensive new revenue recognition standard that will supersede nearly all existing revenue recognition guidance. The objective of ASU 2014-09 is that a company will recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. ASU 2014-09 will be effective for the first quarter of 2017. An entity can elect to adopt ASU 2014-09 using one of two methods, either full retrospective adoption to each prior reporting period, or recognizing the cumulative effect of adoption at the date of initial application. The Company is in the process of evaluating the new standard and does not know the effect, if any, ASU 2014-09 will have on the Consolidated Financial Statements or which adoption method will be used. |
Accumulated Other Comprehensive Loss | Accumulated Other Comprehensive Loss |
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The following table summarizes the changes in accumulated other comprehensive loss, net of tax by component: |
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| | Unrealized | | | Translation | | | Total | | | | | |
Loss on | Adjustments | | | | |
Available | | | | | |
for Sale | | | | | |
Securities | | | | | |
Balance, as of December 31, 2013 | | $ | (22 | ) | | $ | (37 | ) | | $ | (59 | ) | | | | |
Other comprehensive loss before reclassifications | | | (75 | ) | | | (106 | ) | | | (181 | ) | | | | |
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Net current period other comprehensive loss | | $ | (75 | ) | | $ | (106 | ) | | $ | (181 | ) | | | | |
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Balance, as of December 31, 2014 | | $ | (97 | ) | | $ | (143 | ) | | $ | (240 | ) | | | | |