Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2018 | Jul. 31, 2018 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2018 | |
Document Fiscal Year Focus | 2,018 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | ALNY | |
Entity Registrant Name | ALNYLAM PHARMACEUTICALS, INC. | |
Entity Central Index Key | 1,178,670 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 100,666,112 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 361,457 | $ 645,361 |
Marketable debt securities | 1,074,165 | 1,045,257 |
Marketable equity securities | 12,044 | |
Billed and unbilled collaboration receivables | 2,961 | 34,002 |
Prepaid expenses and other current assets | 51,932 | 40,120 |
Total current assets | 1,502,559 | 1,764,740 |
Marketable debt securities | 13,919 | |
Property, plant and equipment, net | 227,839 | 181,900 |
Restricted investments | 44,825 | 30,000 |
Other assets | 14,166 | 4,171 |
Total assets | 1,789,389 | 1,994,730 |
Current liabilities: | ||
Accounts payable | 11,988 | 28,355 |
Accrued expenses | 89,867 | 72,203 |
Deferred rent | 2,643 | 1,988 |
Deferred revenue | 9,161 | 41,705 |
Total current liabilities | 113,659 | 144,251 |
Deferred rent, net of current portion | 16,220 | 6,626 |
Deferred revenue, net of current portion | 4,522 | 43,075 |
Long-term debt | 30,000 | 30,000 |
Other liabilities | 4,186 | 4,347 |
Total liabilities | 168,587 | 228,299 |
Commitments and contingencies (Note 5) | ||
Stockholders’ equity: | ||
Preferred stock, $0.01 par value per share, 5,000,000 shares authorized and no shares issued and outstanding at June 30, 2018 and December 31, 2017 | ||
Common stock, $0.01 par value per share, 125,000,000 shares authorized; 100,569,034 shares issued and outstanding at June 30, 2018; 99,666,549 shares issued and outstanding at December 31, 2017 | 1,005 | 997 |
Additional paid-in capital | 4,037,853 | 3,947,552 |
Accumulated other comprehensive loss | (33,807) | (34,433) |
Accumulated deficit | (2,384,249) | (2,147,685) |
Total stockholders’ equity | 1,620,802 | 1,766,431 |
Total liabilities and stockholders’ equity | $ 1,789,389 | $ 1,994,730 |
CONDENSED CONSOLIDATED BALANCE3
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Jun. 30, 2018 | Dec. 31, 2017 |
Statement Of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 125,000,000 | 125,000,000 |
Common stock, shares issued | 100,569,034 | 99,666,549 |
Common stock, shares outstanding | 100,569,034 | 99,666,549 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) shares in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | ||
Net revenues from collaborators | $ 29,907,000 | $ 15,932,000 | $ 51,806,000 | $ 34,892,000 | |
Operating expenses: | |||||
Research and development | [1] | 137,582,000 | 90,627,000 | 234,439,000 | 177,611,000 |
General and administrative | [1] | 84,679,000 | 45,779,000 | 157,126,000 | 84,266,000 |
Total operating expenses | 222,261,000 | 136,406,000 | 391,565,000 | 261,877,000 | |
Loss from operations | (192,354,000) | (120,474,000) | (339,759,000) | (226,985,000) | |
Other income (expense): | |||||
Interest income | 6,101,000 | 2,577,000 | 11,895,000 | 4,705,000 | |
Other income (expense) | 2,208,000 | (523,000) | 2,543,000 | (3,430,000) | |
Gain on litigation settlement | 20,564,000 | 20,564,000 | |||
Total other income | 28,873,000 | 2,054,000 | 35,002,000 | 1,275,000 | |
Loss before income taxes | (163,481,000) | (118,420,000) | (304,757,000) | (225,710,000) | |
Provision for income taxes | (79,000) | (17,000) | |||
Net loss | $ (163,560,000) | $ (118,420,000) | $ (304,774,000) | $ (225,710,000) | |
Net loss per common share - basic and diluted | $ (1.63) | $ (1.34) | $ (3.04) | $ (2.59) | |
Weighted-average common shares used to compute basic and diluted net loss per common share | 100,519 | 88,098 | 100,251 | 87,068 | |
Comprehensive loss: | |||||
Net loss | $ (163,560,000) | $ (118,420,000) | $ (304,774,000) | $ (225,710,000) | |
Unrealized gain (loss) on marketable securities, net of tax | 1,046,000 | (476,000) | 626,000 | (2,412,000) | |
Reclassification adjustment for realized loss on marketable securities included in net loss | 345,000 | 1,894,000 | |||
Comprehensive loss | (162,514,000) | (118,551,000) | (304,148,000) | (226,228,000) | |
Collaboration Agreement | |||||
Net revenues from collaborators | $ 29,907,000 | $ 15,932,000 | $ 51,806,000 | $ 34,892,000 | |
[1] | Stock-based compensation expenses included in operating expenses are as follows: Research and development $11,616 $13,254 $21,753 $21,945 General and administrative 10,625 10,776 20,072 17,802 |
CONDENSED CONSOLIDATED STATEME5
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Stock-based compensation | $ 41,825 | $ 39,747 | ||
Research and Development | ||||
Stock-based compensation | $ 11,616 | $ 13,254 | 21,753 | 21,945 |
General and Administrative | ||||
Stock-based compensation | $ 10,625 | $ 10,776 | $ 20,072 | $ 17,802 |
CONDENSED CONSOLIDATED STATEME6
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2018 | Jun. 30, 2017 | |
Cash flows from operating activities: | ||
Net loss | $ (304,774) | $ (225,710) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation, amortization and accretion, net | 5,417 | 6,066 |
Stock-based compensation | 41,825 | 39,747 |
Non-cash gain on litigation settlement | (10,000) | |
Charge for 401(k) company stock match | 2,326 | 1,074 |
Unrealized gain on marketable equity securities | (2,044) | |
Realized loss on sale of marketable equity securities | 1,894 | |
Other | 608 | |
Changes in operating assets and liabilities: | ||
Proceeds from landlord lease incentive for tenant improvements | 4,480 | |
Billed and unbilled collaboration receivables | 31,041 | 7,929 |
Prepaid expenses and other assets | (21,261) | (198) |
Accounts payable | (9,735) | (8,326) |
Accrued expenses and other | 7,261 | (3,404) |
Deferred revenue | (2,887) | (1,059) |
Net cash used in operating activities | (258,351) | (181,379) |
Cash flows from investing activities: | ||
Purchases of property, plant and equipment | (43,965) | (57,803) |
Purchases of restricted investments | (14,825) | |
Purchases of marketable debt securities | (642,787) | (237,184) |
Sales and maturities of marketable securities | 629,384 | 302,392 |
Net cash (used in) provided by investing activities | (72,193) | 7,405 |
Cash flows from financing activities: | ||
Proceeds from exercise of stock options and other types of equity | 47,735 | 12,644 |
Proceeds from issuance of common stock, net of offering costs | 355,150 | |
Proceeds from issuance of common stock to Sanofi Genzyme | 21,381 | |
Payments for repurchase of common stock for employee tax withholding | (632) | (147) |
Net cash provided by financing activities | 47,103 | 389,028 |
Net (decrease) increase in cash, cash equivalents and restricted cash | (283,441) | 215,054 |
Cash, cash equivalents and restricted cash, beginning of period | 646,832 | 195,088 |
Cash, cash equivalents and restricted cash, end of period | $ 363,391 | $ 410,142 |
CONDENSED CONSOLIDATED STATEME7
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Parenthetical) - USD ($) $ in Thousands | Jun. 30, 2018 | Jun. 30, 2017 |
Statement Of Cash Flows [Abstract] | ||
Cash and cash equivalents | $ 361,457 | $ 408,671 |
Restricted cash included in long-term other assets | 1,934 | 1,471 |
Total cash, cash equivalents, and restricted cash shown in the condensed consolidated statements of cash flows | $ 363,391 | $ 410,142 |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 6 Months Ended |
Jun. 30, 2018 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation and Principles of Consolidation The accompanying condensed consolidated financial statements of Alnylam Pharmaceuticals, Inc. are unaudited and have been prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP, applicable to interim periods and, in the opinion of management, include all normal and recurring adjustments that are necessary to state fairly the results of operations for the reported periods. Our condensed consolidated financial statements have also been prepared on a basis substantially consistent with, and should be read in conjunction with, our audited consolidated financial statements for the year ended December 31, 2017, which were included in our Annual Report on Form 10-K that was filed with the Securities and Exchange Commission, or SEC, on February 15, 2018. The year-end condensed consolidated balance sheet data was derived from our audited financial statements, but does not include all disclosures required by GAAP. The results of our operations for any interim period are not necessarily indicative of the results of our operations for any other interim period or for a full fiscal year. The accompanying condensed consolidated financial statements reflect the operations of Alnylam and our wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated. Use of Estimates The preparation of financial statements in conformity with 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 condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Liquidity Based on our current operating plan, we believe that our cash, cash equivalents and marketable debt securities at June 30, 2018, together with the cash we expect to generate under our current alliances, will be sufficient to enable us to advance our Alnylam 2020 Net Loss Per Common Share We compute basic net loss per common share by dividing net loss by the weighted-average number of common shares outstanding. We compute diluted net loss per common share by dividing net loss by the weighted-average number of common shares and dilutive potential common share equivalents then outstanding. Potential common shares consist of shares issuable upon the exercise of stock options (the proceeds of which are then assumed to have been used to repurchase outstanding shares using the treasury stock method). Because the inclusion of potential common shares would be anti-dilutive for all periods presented, diluted net loss per common share is the same as basic net loss per common share. The following table sets forth for the periods presented the potential common shares (prior to consideration of the treasury stock method) excluded from the calculation of net loss per common share because their inclusion would be anti-dilutive, in thousands: At June 30, 2018 2017 Options to purchase common stock 12,794 12,372 Unvested restricted common stock 150 172 12,944 12,544 Public Offering In May 2017, we sold an aggregate of 5,000,000 shares of our common stock through an underwritten public offering at a price to the public of $71.87 per share. As a result of the offering, we received aggregate net proceeds of $355.2 million after deducting underwriting discounts and commissions and other offering expenses of $4.2 million. Equity Total stockholders’ equity at June 30, 2018 decreased by $145.6 million compared to December 31, 2017. This decrease was related primarily to our net loss, partially offset during the six months ended June 30, 2018 by an adjustment to the opening balance of our accumulated deficit related to the adoption of the new revenue standard on January 1, 2018, described below under the heading “Recent Accounting Pronouncements,” as well as increases to additional paid-in capital due to proceeds from the exercise of stock options and stock-based compensation. Fair Value Measurements The fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. 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 data points that are observable, such as quoted prices (adjusted), interest rates and yield curves. Fair values determined by Level 3 inputs utilize unobservable data points for the asset or liability, and include situations where there is little, if any, market activity for the asset or liability. The fair value hierarchy level is determined by the lowest level of significant input. Investments in Marketable Securities and Cash Equivalents We invest our excess cash balances in short-term and long-term marketable debt securities. We classify our investments in marketable debt securities as either held-to-maturity or available-for-sale based on facts and circumstances present at the time we purchased the securities. At each balance sheet date presented, we classified all of our investments in debt securities as available-for-sale. We report available-for-sale debt securities at fair value at each balance sheet date and include any unrealized holding gains and losses (the adjustment to fair value) in accumulated other comprehensive income (loss), a component of stockholders’ equity. At June 30, 2018, the balance in our accumulated other comprehensive loss was composed solely of activity related to our marketable debt securities and our investment in equity securities of Regulus Therapeutics Inc., or Regulus. Realized gains and losses are determined using the specific identification method and are included in other income (expense). We did not recognize any realized gains or losses from sales of our available-for-sale debt securities during the six months ended June 30, 2018 or 2017, and as a result, did not reclassify any amount out of accumulated other comprehensive loss for the respective period related to our available-for-sale debt securities. If any adjustment to fair value reflects a decline in the value of the marketable debt securities, we consider all available evidence to evaluate the extent to which the decline is “other than temporary,” including our intention to sell and, if so, mark the investment to market through a charge to our condensed consolidated statements of comprehensive loss. We did not record any impairment charges related to our marketable debt securities during the six months ended June 30, 2018 or 2017. Our marketable debt securities are classified as cash equivalents if the original maturity, from the date of purchase, is 90 days or less, and as marketable debt securities if the original maturity, from the date of purchase, is in excess of 90 days. Our cash equivalents are composed of certificates of deposit, commercial paper, corporate notes, U.S. government-sponsored enterprise securities, U.S. treasury securities and money market funds. Upon the adoption of the new accounting standard, discussed below under the heading “Recent Accounting Pronouncements,” effective January 1, 2018, we measure marketable equity investments (except those accounted for under the equity method of accounting or those that result in consolidation of an investee), which have readily available prices, at fair value with changes in fair value recognized in other income (expense) on our condensed consolidated statements of comprehensive loss 983,208 shares of Dicerna Pharmaceuticals, Inc., or Dicerna, common stock that we received under a Settlement Agreement and General Release entered into in April 2018, referred to as the Settlement Agreement, described more fully below at Note 5. During the second quarter of 2017, we sold all our remaining holdings in Regulus. We accounted for our investment in Regulus as an available-for-sale marketable equity security. We recognized $0.3 million and $1.9 million of realized losses from sales of our Regulus available-for-sale securities as other expense in our condensed consolidated statement of comprehensive loss during the three and six months ended June 30, 2017, respectively. Intraperiod tax allocation rules require us to allocate our provision for income taxes between continuing operations and other categories of earnings, such as other comprehensive income. In periods in which we have a year-to-date pre-tax loss from continuing operations and pre-tax income in other categories of earnings, such as other comprehensive income, we must allocate the tax provision to the other categories of earnings. We then record a related tax benefit in continuing operations. Upon sales of our marketable equity securities, we apply the aggregate portfolio approach to recognize the related tax provision or benefit into income (loss) from continuing operations. As a result, the disproportionate tax effect remains in accumulated other comprehensive income (loss) as long as we maintain an investment portfolio. At June 30, 2018 and December 31, 2017, there was $32.8 million of accumulated other comprehensive loss, net of tax, recorded on our condensed consolidated balance sheets related to our investment in Regulus. Revenue Recognition We have entered into collaboration agreements with leading pharmaceutical and life sciences companies, including Sanofi Genzyme, the specialty care global business unit of Sanofi, and The Medicines Company, or MDCO. The terms of our collaboration agreements may include consideration such as non-refundable license fees, funding of research and development services, payments due upon the achievement of clinical and pre-clinical performance-based development milestones, regulatory milestones, manufacturing services, sales-based milestones and royalties on product sales. On January 1, 2018, we adopted the new revenue standard, discussed below under the heading “Recent Accounting Pronouncements,” which amended revenue recognition principles and provides a single, comprehensive set of criteria for revenue recognition within and across all industries. Our adoption of the new revenue standard had a material impact on our condensed consolidated financial statements, as discussed below under the heading “Recent Accounting Pronouncements.” This new revenue standard applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. The new revenue standard provides a five-step framework whereby revenue is recognized when control of promised goods or services is transferred to a customer at an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. To determine revenue recognition for arrangements that we determine are within the scope of the new revenue standard, we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy a performance obligation. We only apply the five-step model to contracts when collectability of the consideration to which we are entitled in exchange for the goods or services we transfer to the customer is determined to be probable. At contract inception, once the contract is determined to be within the scope of the new revenue standard, we assess whether the goods or services promised within each contract are distinct and, therefore, represent a separate performance obligation. Goods and services that are determined not to be distinct are combined with other promised goods and services until a distinct bundle is identified. We then allocate the transaction price (the amount of consideration we expect to be entitled to from a customer in exchange for the promised goods or services) to each performance obligation and recognize the associated revenue when (or as) each performance obligation is satisfied. Our estimate of the transaction price for each contract includes all variable consideration to which we expect to be entitled. We recognize the transaction price allocated to upfront license payments as revenue upon delivery of the license to the customer and resulting ability of the customer to use and benefit from the license, if the license is determined to be distinct from the other performance obligations identified in the contract. we utilize judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied (i) at a point in time, but only for licenses determined to be distinct from other performance obligations in the contract, or (ii) over time; and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from license payments. We evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition. Many of our collaboration agreements entitle us to additional payments upon the achievement of performance-based milestones. These milestones are generally categorized into three types: development milestones, generally based on the advancement of our pipeline and initiation of clinical trials; regulatory milestones, generally based on the submission, filing or approval of regulatory applications such as a New Drug Application, or NDA, in the United States; and sales-based milestones, generally based on meeting specific thresholds of sales in certain geographic areas. For each collaboration that includes development milestone payments, we evaluate whether it is probable that the consideration associated with each milestone will not be subject to a significant reversal in the cumulative amount of revenue recognized. Amounts that meet this threshold are included in the transaction price using the most likely amount method, whereas amounts that do not meet this threshold are considered constrained and excluded from the transaction price until they meet this threshold. At the end of each subsequent reporting period, we re-evaluate the probability of a significant reversal of the cumulative revenue recognized for our milestones, and, if necessary, adjust our estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues from collaborators and loss in the period of adjustment. have not recognized any royalty revenue resulting from any of our agreements. The new revenue standard requires us to allocate the arrangement consideration on a relative standalone selling price basis for each performance obligation after determining the transaction price of the contract and identifying the performance obligations to which that amount should be allocated. The relative standalone selling price is defined in the new revenue standard as the price at which an entity would sell a promised good or service separately to a customer. If other observable transactions in which we have sold the same performance obligation separately are not available, we are required to estimate the standalone selling price of each performance obligation. Key assumptions to determine the standalone selling price may include forecasted revenues, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical and regulatory success. Whenever we determine that a contract should be accounted for as a combined performance obligation over time, we determine the period over which the performance obligations will be performed and revenue will be recognized. Revenue is recognized using the proportional performance method. Direct labor hours or full-time equivalents are typically used as the measure of performance. Significant management judgment is required in determining the level of effort required under an arrangement and the period over which we are expected to complete our performance obligations under an arrangement. We evaluate our collaborative agreements for proper classification in our consolidated statements of comprehensive loss based on the nature of the underlying activity. Transactions between collaborators recorded in our consolidated statements of comprehensive loss are recorded on either a gross or net basis, depending on the characteristics of the collaborative relationship. We generally reflect amounts due under our collaborative agreements related to cost-sharing of development activities as revenue if we have a vendor-customer relationship with our collaborator. Costs incurred or shared with our collaboration partners that are deemed to be joint-risk sharing activities are recorded as an adjustment to the related operating expense captions. For revenue generating arrangements where we, as a vendor, provide consideration to a licensor or collaborator, as a customer, we apply the accounting standard that governs such transactions. This standard addresses the accounting for revenue arrangements where both the vendor and the customer make cash payments to each other for services and/or products. A payment to a customer is presumed to be a reduction of the transaction price unless we receive an identifiable benefit for the payment and we can reasonably estimate the fair value of the benefit received. Payments to a customer that are deemed a reduction of the transaction price are recorded first as a reduction of revenue, to the extent of both cumulative revenue recorded to date and probable future revenues, which include any unamortized deferred revenue balances, under all arrangements with such customer, and then as an expense. Payments that are not deemed to be a reduction of the transaction price are recorded as an expense. Consideration that does not meet the requirements to satisfy the above revenue recognition criteria is recorded as deferred revenue in the accompanying condensed consolidated balance sheets. Although we follow detailed guidelines in measuring revenue, certain judgments affect the application of our revenue policy. For example, in connection with our existing collaboration agreements, we have recorded on our condensed consolidated balance sheets short-term and long-term deferred revenue based on our best estimate of when such revenue will be recognized. Short-term deferred revenue consists of amounts that are expected to be recognized as revenue in the next 12 months. Amounts that we expect will not be recognized within the next 12 months are classified as long-term deferred revenue. However, this estimate is based on our current operating plan and, if our operating plan should change in the future, we may recognize a different amount of deferred revenue over the next 12-month period. The estimate of deferred revenue also reflects management’s estimate of the periods of our involvement in certain of our collaborations. Our performance obligations under these collaborations consist of participation on steering committees and the performance of other research and development services. In certain instances, the timing of satisfying these obligations can be difficult to estimate. Accordingly, our estimates may change in the future. Such changes to estimates would result in a change in revenue recognition amounts. If these estimates and judgments change over the course of these agreements, it may affect the timing and amount of revenue that we recognize and record in future periods. At June 30, 2018, we had short-term and long-term deferred revenue of $9.2 million and $4.5 million, respectively, related to our collaborations. Amounts are recorded as accounts receivable when our right to consideration is unconditional. We do not assess whether a contract has a significant financing component if the expectation at contract inception is that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less. We expense incremental costs of obtaining a contract as and when incurred if the expected amortization period of the asset that we would have recognized is one year or less or the amount is immaterial. At June 30, 2018, we have not capitalized any costs to obtain any of our contracts. Other Income As described more fully below at Note 5, Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board, or FASB, issued a new revenue recognition standard, which we refer to as the new revenue standard, which amends revenue recognition principles and provides a single, comprehensive set of criteria for revenue recognition within and across all industries. The new revenue standard provides a five-step framework whereby revenue is recognized when control of promised goods or services are transferred to a customer at an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The new revenue standard also requires enhanced disclosures pertaining to revenue recognition in both interim and annual periods. In August 2015, the FASB deferred the effective date of the new revenue standard from January 1, 2017 to January 1, 2018. In March 2016, the FASB issued amendments to clarify the implementation standard on principal versus agent considerations. In April 2016, the FASB issued amendments to clarify the standard on accounting for licenses of intellectual property and identifying performance obligations. In May 2016, the FASB issued amendments related to collectibility, non-cash consideration, the presentation of sales and other similar taxes collected from customers and transition. The new revenue standard allows for adoption using a full retrospective method or a modified retrospective method. On January 1, 2018, we adopted the new revenue standard by applying the modified retrospective method to all contracts that were not completed as of January 1, 2018. As a result, while reporting periods beginning on our adoption of the new revenue standard are presented under the new revenue standard, prior period amounts have not been adjusted and continue to be presented under the revenue standard in effect prior to January 1, 2018. For contracts that were modified prior to our adoption of the new revenue standard, we reflected the aggregate effect of all modifications that occurred before the beginning of the earliest period presented when identifying performance obligations and allocating the transaction price in accordance with an available practical expedient. Our implementation approach included performing a detailed review of our collaboration agreements not completed as of the transition date. In addition, we designed internal controls to enable the preparation of financial information and have reached conclusions on key accounting assessments related to the new revenue standard, including our assessment that the impact of accounting for costs incurred to obtain a contract is immaterial. There was no impact to cash from or used in operating, financing or investing activities on our condensed consolidated statement of cash flows as a result of the adoption of the new revenue standard. The following table summarizes the cumulative effect to our condensed consolidated balance sheet upon the adoption of the new revenue standard on January 1, 2018, in thousands: Condensed Consolidated Balance Sheet Balance at December 31, 2017 Adjustments Balance at January 1, 2018 Deferred revenue, current portion $ 41,705 $ (34,463 ) $ 7,242 Deferred revenue, net of current portion $ 43,075 $ (33,747 ) $ 9,328 Accumulated deficit $ (2,147,685 ) $ 68,210 $ (2,079,475 ) The adoption of the new revenue standard resulted in a cumulative reduction of $68.2 million of deferred revenue with a corresponding adjustment to the opening balance of accumulated deficit recorded in the first quarter of 2018. This adjustment is due primarily to the application of the new revenue standard to our collaboration agreements with Sanofi Genzyme, MDCO and Kyowa Hakko Kirin Co., Ltd., or A substantial portion of the incremental $68.2 million adjustment is the result of the application of the new revenue standard regarding how entities should measure progress in satisfying performance obligations and the contract’s transaction price. In particular, for Sanofi Genzyme and MDCO, the adoption of the new revenue standard resulted in the recognition of previously deferred revenue of $45.7 million and $4.5 million, respectively, due to the change in the way we measure our performance under each agreement, from a straight-line method to a proportional performance model. As a result, at January 1, 2018, the balance of remaining deferred revenues was $3.5 million and $1.2 million, respectively, related to Sanofi Genzyme and MDCO. In addition, the adoption of the new revenue standard resulted in the recognition of $15.5 million of previously deferred revenue related to our Kyowa Hakko Kirin we had been unable to reasonably estimate our period of performance under the Kyowa Hakko Kirin agreement as we were unable to estimate the timeline of our deliverables related to the fixed-price option granted to Kyowa Hakko Kirin for any additional compounds, an obligation that was bundled with all other deliverables into a single unit of accounting. Under the new revenue standard, two distinct performance obligations were identified. The first distinct performance obligation included a license to our program targeting respiratory syncytial virus, or RSV, infection , related know-how and updates, manufacturing supply services and joint steering committee services. The second distinct performance obligation included the fixed-price option to a future follow-on compound. We allocated all consideration to the first performance obligation because the second performance obligation was deemed to have a de minimis relative selling price due to its low likelihood of occurring, in part due to our discontinuation of our RSV program. Given this fact pattern, because we do not expect to incur any future costs related to our RSV program, we concluded our performance obligations were complete in the period prior to our adoption of the new revenue standard and therefore, there would not be a future significant reversal of revenue. As a result, we recorded the $15.5 million of deferred revenue as of December 31, 2017 as an adjustment to the opening balance of our accumulated deficit on January 1, 2018. In accordance with the new revenue standard requirements, the following tables summarize the impact of adoption on our condensed consolidated balance sheet and condensed consolidated statement of comprehensive loss, in thousands: At June 30, 2018 Condensed Consolidated Balance Sheet As Reported Balances Without Adoption of New Revenue Standard Effect of Change Higher/(Lower) Deferred revenue, current portion $ 9,161 $ 9,860 $ (699 ) Deferred revenue, net of current portion $ 4,522 $ 22,514 $ (17,992 ) Accumulated deficit $ (2,384,249 ) $ (2,403,024 ) $ (18,775 ) Three Months Ended June 30, 2018 Condensed Consolidated Statement of Comprehensive Loss As Reported Balances Without Adoption of New Revenue Standard Effect of Change Higher/(Lower) Net revenues from collaborators $ 29,907 $ 46,215 $ (16,308 ) Net loss $ (163,560 ) $ (147,252 ) $ 16,308 Net loss per common share - basic and diluted $ (1.63 ) $ (1.46 ) $ 0.17 Six Months Ended June 30, 2018 Condensed Consolidated Statement of Comprehensive Loss As Reported Balances Without Adoption of New Revenue Standard Effect of Change Higher/(Lower) Net revenues from collaborators $ 51,806 $ 101,241 $ (49,435 ) Net loss $ (304,774 ) $ (255,339 ) $ 49,435 Net loss per common share - basic and diluted $ (3.04 ) $ (2.55 ) $ 0.49 In addition to the reduction to deferred revenues recorded and corresponding offset to the accumulated deficit described above, on January 6, 2018, we and Sanofi Genzyme entered into an amendment to our 2014 Sanofi Genzyme collaboration. In connection and simultaneously with entering into the amendment to the 2014 Sanofi Genzyme collaboration, we and Sanofi Genzyme also entered into an Exclusive License Agreement with respect to all TTR products, including patisiran, ALN-TTRsc02 and any back-up products, referred to as the Exclusive TTR License, and the ALN-AT3 Global License Terms with respect to fitusiran and any back-up products, referred to as the AT3 License Terms. In January 2016, the FASB issued a new standard on recognition and measurement of financial assets and financial liabilities. The new standard impacts the accounting for equity investments, financial liabilities under the fair value option, and the presentation and disclosure requirements for financial instruments. All equity investments in unconsolidated entities (other than those accounted for under the equity method of accounting) will generally be measured at fair value with changes in fair value recognized through earnings. There is no longer an available-for-sale classification (changes in fair value reported in other comprehensive income (loss)) for equity securities with readily determinable fair values. For equity investments that do not have readily determinable fair values, such as privately issued corporate equity securities, we have elected the measurement alternative. As a result, we will record these investments at cost, less any impairment, and adjust for observable price changes in orderly transactions for identical or similar investments of the same issuer. At June 30, 2018 and December 31, 2017, we did not have material equity investments without readily determinable fair values. In addition, the FASB clarified the need for a valuation allowance on deferred tax assets resulting from unrealized losses on available-for-sale debt securities. In general, the new standard requires modified retrospective application to all outstanding instruments, with a cumulative effect adjustment recorded to opening retained earnings. This standard became effective for us on January 1, 2018. This standard had an impact on our condensed consolidated financial statements and related disclosures beginning in the second quarter of 2018 as a result of the 983,208 shares of common stock of Dicerna, a publicly traded company, that we received in April 2018, described more fully above. During the three and six months ended June 30, 2018, we recorded an unrealized gain of $2.0 million for the change in the fair value of such shares of Dicerna common stock as other income on our condensed consolidated statements of comprehensive loss as a result of the application of this new standard. In February 2016, the FASB issued a new leasing standard that requires that all lessees recognize the assets and liabilities that arise from leases on the condensed consolidated balance sheet and disclose qualitative and quantitative information about its leasing arrangements. The new standard will be effective for us on January 1, 2019. Early adoption is permitted. We are currently evaluating the timing of our adoption and the expected impact that this standard could have on our condensed consolidated financial statements and related disclosures. In November 2016, the FASB issued a new standard that requires restricted cash and restricted cash equivalents be included with cash and cash equivalents when reconciling the total beginning and ending amounts for the periods shown on the condensed consolidated statements of cash flows. The new standard became effective for us on January 1, 2018 using a retrospective transition method for each period presented. For the years ended December 31, 2017 and 2016, our restricted cash and restricted cash equivalents were not significant. This standard did not have a significant impact on our condensed consolidated financial statements and related disclosures. In March 2017, the FASB issued a new standard that amends the amortization period for certain purchased callable debt securities held at a premium by shortening the amortization period for the premium to the earliest call date. The new standard will be effective for us on January 1, 2019. Early adoption is permitted. We are currently evaluating the timing of our adoption and the expected impact that this standard |
COLLABORATION AGREEMENTS
COLLABORATION AGREEMENTS | 6 Months Ended |
Jun. 30, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
COLLABORATION AGREEMENTS | 2. COLLABORATION AGREEMENTS The following table summarizes our total consolidated net revenues from collaborators, for the periods indicated, in thousands: Three Months Ended June 30, Six Months Ended June 30, Description 2018 2017 2018 2017 Sanofi Genzyme $ 23,077 $ 14,375 $ 41,930 $ 26,652 Vir Biotechnology 6,113 — 7,356 — MDCO 662 1,522 1,957 7,886 Other 55 35 563 354 Total net revenues from collaborators $ 29,907 $ 15,932 $ 51,806 $ 34,892 The following table summarizes our total consolidated net revenues from collaborators, using the prior revenue standard, for the periods indicated, in thousands: Three Months Ended June 30, Six Months Ended June 30, Description 2018 2017 2018 2017 Sanofi Genzyme $ 36,539 $ 14,375 $ 86,969 $ 26,652 Vir Biotechnology 6,113 — 7,356 — MDCO 3,508 1,522 6,353 7,886 Other 55 35 563 354 Total net revenues from collaborators $ 46,215 $ 15,932 $ 101,241 $ 34,892 The following table presents the balance of our contract liabilities at June 30, 2018 and January 1, 2018, in thousands: At June 30, 2018 At January 1, 2018 Contract liabilities: Deferred revenues $ 13,683 $ 16,570 During the six months ended June 30, 2018, we recognized the following revenues as a result of the change in the contract liability balances, in thousands: Revenue recognized in the period from: Six Months Ended June 30, 2018 Amounts included in contract liability at the beginning of the period $ 11,996 In order to determine revenue recognized in the period from contract liabilities, we first allocate revenue to the individual contract liability balance outstanding at the beginning of the period until the revenue exceeds that balance. If additional consideration is received on those contracts in subsequent periods, we assume all revenue recognized in the reporting period first applies to the beginning contract liability as opposed to a portion applying to the new consideration for the period. The following table provides the research and development expenses incurred by type that are directly attributable to each agreement for the periods indicated, in thousands: Three Months Ended June 30, Six Months Ended June 30, 2018 2017 2018 2017 Sanofi Genzyme Vir MDCO Sanofi Genzyme Vir MDCO Sanofi Genzyme Vir MDCO Sanofi Genzyme Vir MDCO Research and development Clinical trial and manufacturing $ 17,572 $ 5,497 $ — $ 43,780 $ — $ — $ 28,095 $ 6,051 $ 641 $ 84,355 $ — $ 5,095 External services 1,834 6,151 — 929 — — 4,507 6,351 — 1,496 — — Other 241 292 — 1,554 — — 750 980 — 2,990 — 24 Total research and development expenses $ 19,647 $ 11,940 $ — $ 46,263 $ — $ — $ 33,352 $ 13,382 $ 641 $ 88,841 $ — $ 5,119 The research and development expenses incurred for each agreement listed in the table above consist of costs incurred for external development and manufacturing services for which we are reimbursed, licensing payments made to the counterparty to such agreement and costs directly attributable to Sanofi Genzyme transition services. In addition, these expenses include a reasonable estimate of compensation and related costs as billed to our counterparties. As part of our revenue recognition policy, the costs in the above table are considered as an input in our determination of transaction price when they relate to consideration received for the delivery of goods or services. For the three and six months ended June 30, 2018 and 2017, we did not incur material general and administrative expenses related to our significant agreements. Product Alliances Sanofi Genzyme Collaboration In January 2014, we entered into a global, strategic collaboration with Sanofi Genzyme to discover, develop and commercialize RNAi therapeutics as Genetic Medicines to treat orphan diseases, referred to as the 2014 Sanofi Genzyme collaboration. The 2014 Sanofi Genzyme collaboration superseded and replaced the previous collaboration between us and Sanofi Genzyme entered into in October 2012 to develop and commercialize RNAi therapeutics targeting transthyretin, or TTR, for the treatment of hereditary ATTR amyloidosis, including patisiran and revusiran, in Japan and the Asia-Pacific region. On January 6, 2018, we and Sanofi Genzyme entered into an amendment to our 2014 Sanofi Genzyme collaboration. In connection and simultaneously with entering into the amendment to the 2014 Sanofi Genzyme collaboration, we and Sanofi Genzyme also entered into the Exclusive TTR License and the AT3 License Terms. As a result, we have the exclusive right to pursue the further global development and commercialization of all TTR products, including patisiran, ALN-TTRsc02 and any back-up products, and Sanofi Genzyme has the exclusive right to pursue the further global development and commercialization of fitusiran and any back-up products. The January 2018 transaction was subject to customary closing conditions and clearances, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act, and closed during the first quarter of 2018. 2012 Sanofi Genzyme Agreement Under the 2012 Sanofi Genzyme agreement, Sanofi Genzyme paid us an upfront cash payment of $22.5 million. We were also entitled to receive certain milestone payments under the 2012 Sanofi Genzyme agreement. In the fourth quarter of 2013, we earned $11.0 million in patisiran development milestones under the 2012 Sanofi Genzyme agreement. We determined that the deliverables under the 2012 Sanofi Genzyme agreement included the license, a joint steering committee and any additional TTR-specific RNAi therapeutic compounds that comprised the ALN-TTR program. We also determined that, pursuant to the accounting guidance governing revenue recognition on multiple element arrangements, the license and undelivered joint steering committee and any additional TTR-specific RNAi therapeutic compounds did not have standalone value due to the specialized nature of the services to be provided by us. In addition, while Sanofi Genzyme had the ability to grant sublicenses, it could not sublicense all or substantially all of its rights under the 2012 Sanofi Genzyme agreement. The uniqueness of our services and the limited sublicense right were indicators that standalone value was not present in the arrangement. Therefore, the deliverables were not separable and, accordingly, the license and undelivered services were treated as a single unit of accounting. We were unable to reasonably estimate the period of performance under the 2012 Sanofi Genzyme agreement, as we were unable to estimate the timeline of our deliverables related to the deliverable for any additional TTR-specific RNAi therapeutic compounds. Through December 31, 2013, under the prior revenue standard, we had deferred all revenue, or $33.5 million, under the 2012 Sanofi Genzyme agreement. 2014 Sanofi Genzyme Collaboration, as amended in January 2018 In January 2014, we entered into the 2014 Sanofi Genzyme collaboration. As noted above, the 2014 Sanofi Genzyme collaboration superseded and replaced the 2012 Sanofi Genzyme agreement and was amended in January 2018, at which time we also entered into the Exclusive TTR License and the AT3 License Terms. The 2014 Sanofi Genzyme collaboration is structured as an exclusive relationship for the worldwide development and commercialization of RNAi therapeutics in the field of Genetic Medicines, which includes our current and future Genetic Medicine programs that reach Human Proof-of-Principle Study Completion (as defined in the Sanofi Genzyme master agreement), or Human POP, by the end of 2019, subject to extension to the end of 2021 in various circumstances. We will retain product rights in the United States, Canada and Western Europe, referred to as the Alnylam Territory, while Sanofi Genzyme will obtain exclusive rights to develop and commercialize collaboration products in the rest of the world, referred to as the Sanofi Genzyme Territory, together with worldwide rights for one product. Sanofi Genzyme’s rights under the 2014 Sanofi Genzyme collaboration, described in detail below, are structured as an opt-in that is triggered upon achievement of Human POP. We maintain development control for all programs prior to Sanofi Genzyme’s opt-in and maintain development and commercialization control after Sanofi Genzyme’s opt-in for all programs in the Alnylam Territory. We will retain global rights to any RNAi therapeutic Genetic Medicine program that does not reach Human POP by the end of 2019, subject to certain limited exceptions. We retain full rights to all current and future RNAi therapeutic programs outside of the field of Genetic Medicines, including the right to form new collaborations. Under the 2014 Sanofi Genzyme collaboration, Sanofi Genzyme’s specific license rights and the programs which Sanofi Genzyme opted into prior to the 2018 amendment include the following: • Regional license terms and programs — Upon opt-in, we will retain product rights in the Alnylam Territory, while Sanofi Genzyme will obtain exclusive rights to develop and commercialize the product in the Sanofi Genzyme Territory. Sanofi Genzyme can elect this license for any of our current and future Genetic Medicine programs that complete Human POP by the end of 2019, subject to limited extension. Development costs for products once Sanofi Genzyme exercises an option will be shared between Sanofi Genzyme and us, with Sanofi Genzyme responsible for twenty percent of the global development costs. Sanofi Genzyme will be required to make payments totaling up to $75.0 million per regional product, consisting of up to $55.0 million in development milestones and $20.0 million in commercial milestones. Sanofi Genzyme will also be required to pay tiered double-digit royalties up to twenty percent for each regional product based on annual net sales, if any, of such regional product by Sanofi Genzyme, its affiliates and sublicensees. Upon the effective date of the 2014 Sanofi Genzyme collaboration, Sanofi Genzyme expanded the scope of its regional license and collaboration for patisiran, which was originally established under the 2012 Sanofi Genzyme agreement. In September 2015, Sanofi Genzyme elected to opt into our fitusiran clinical development program for the treatment of hemophilia and other rare bleeding disorders under the regional license terms. Cost-sharing for the fitusiran program began in January 2016 under the regional license terms. Sanofi Genzyme also had the right to elect to co-develop and co-commercialize fitusiran in the Alnylam Territory pursuant to the co-development/co-commercialize license terms described below. In November 2016, Sanofi Genzyme exercised this right and elected to co-develop and co-commercialize fitusiran in the Alnylam Territory. In addition, during 2016, Sanofi Genzyme elected not to opt into the development and commercialization of givosiran or cemdisiran in the Sanofi Genzyme Territory. Sanofi Genzyme’s rights with respect to patisiran and fitusiran were modified in connection with the 2018 amendment, the Exclusive TTR License the AT3 License Terms, as described below. Sanofi • Co-development/co-commercialize license terms and programs — Upon opt-in, we retained product rights in the Alnylam Territory, while Sanofi Genzyme obtained exclusive rights to develop and commercialize the product in the Sanofi Genzyme Territory, and to co-commercialize the product in the Alnylam Territory. Upon the effective date of the 2014 Sanofi Genzyme collaboration, Sanofi Genzyme expanded its regional rights for revusiran, which were originally granted under the 2012 Sanofi Genzyme agreement, to include a co-development/co-commercialize license and collaboration. In October 2016, we decided to discontinue development of revusiran. In our TTR program, we are also developing ALN-TTRsc02. Sanofi Genzyme had a right to elect a co-development/co-commercialize license for ALN-TTRsc02. As noted above, in November 2016, Sanofi Genzyme exercised its right to elect a co-development/co-commercialize license for fitusiran. Development costs for co-development/co-commercialize products, once Sanofi Genzyme exercised an option, were shared between Sanofi Genzyme and us, with Sanofi Genzyme responsible for fifty percent of the global development costs. In connection with the exercise of its co-development/co-commercialize rights for fitusiran, Sanofi Genzyme paid us approximately $6.0 million in January 2017 for its incremental share of co-development costs incurred from January 2016 through September 2016. Sanofi Genzyme was required to make certain milestone payments for fitusiran, and, prior to the discontinuation of the revusiran program, was required to make certain milestone payments for revusiran. In December 2014, we earned a development milestone payment of $25.0 million based upon the initiation of the first global Phase 3 clinical trial for revusiran. Sanofi Genzyme was also obligated to pay us a milestone of $25.0 million upon the dosing of the first patient in our ATLAS Phase 3 program for fitusiran. In addition, Sanofi Genzyme was required to pay tiered double-digit royalties up to twenty percent for each co-development/co-commercialize product based on annual net sales, if any, in the Sanofi Genzyme Territory for such co-development/co-commercialize product by Sanofi Genzyme, its affiliates and sublicensees. The parties were to share profits equally and we expected to book product sales in the Alnylam Territory. In connection with the 2018 amendment, the Exclusive TTR License the AT3 License Terms, as described below • Global license terms and programs — Sanofi Genzyme continues to have one right to a global license through 2019, subject to limited extension, for a future Genetic Medicine program that was not one of our defined Genetic Medicine programs as of the effective date of the 2014 Sanofi Genzyme collaboration. Upon opt-in, Sanofi Genzyme will obtain a worldwide license to develop and commercialize the product. Sanofi Genzyme shall be responsible for one hundred percent of global development costs for a global license product. Sanofi Genzyme will be required to make payments totaling up to $200.0 million for such global product, including up to $100.0 million in development milestones and $100.0 million in commercial milestones. Sanofi Genzyme will also be required to pay tiered double-digit royalties up to twenty percent for such global product based on annual net sales, if any, of each global product by Sanofi Genzyme, its affiliates and sublicensees. During the first quarter of 2018, Sanofi Genzyme elected not to exercise its global option for our lumasiran program. Exclusive TTR License and AT3 License Terms As noted above, the 2018 amendment, together with the Exclusive TTR License and the AT3 License Terms, revise the terms and conditions of the 2014 Sanofi Genzyme collaboration to (i) provide us the exclusive right to pursue the further global development and commercialization of all TTR products, including patisiran, ALN-TTRsc02 and any back-up products, (ii) provide Sanofi Genzyme the exclusive right to pursue the further global development and commercialization of fitusiran and any back-up products and (iii) terminate the previous co-development and co-commercialization rights related to revusiran, ALN-TTRsc02 and fitusiran under the 2014 Sanofi Genzyme collaboration. Going forward, we are funding all development and commercialization costs for patisiran and ALN-TTRsc02. We are also funding development and commercialization costs for fitusiran through the transition period, up to a cap of $50.0 million, after which Sanofi Genzyme will fund all development and commercialization costs for fitusiran. We substantially completed the transition of the fitusiran program to Sanofi Genzyme in the third quarter of 2018. Each party is responsible for its costs associated with the transfer of the respective program to the other party. Under the 2018 amendment and the Exclusive TTR License, Sanofi Genzyme will be eligible to receive (i) royalties up to twenty-five percent, increasing over time, based on annual net sales of patisiran in territories excluding the United States, Canada and Western Europe, provided royalties on annual net sales of patisiran in Japan will be twenty-five percent beginning as of the effective date of the Exclusive TTR License, (ii) tiered royalties of fifteen to thirty percent based on global annual net sales of ALN-TTRsc02 (consistent with the royalties due to us from Sanofi Genzyme on fitusiran), and (iii) tiered royalties of up to fifteen percent based on global annual net sales of any back-up products, in each case by us, our affiliates and our sublicensees. Except as described below, there will be no additional milestones due to either party with respect to patisiran, ALN-TTRsc02 or fitusiran. In consideration for the rights granted to Sanofi Genzyme under the 2018 amendment and the AT3 License Terms, Sanofi Genzyme was required to make one milestone payment of $50.0 million following the dosing of the first patient in the ATLAS Phase 3 program for fitusiran. This milestone was achieved in the first quarter of 2018. In addition, we will be eligible to receive tiered royalties of fifteen to thirty percent based on global annual net sales of fitusiran and up to fifteen percent based on global annual net sales of any back-up products, in each case by Sanofi Genzyme, its affiliates and its sublicensees. We intend to continue to work with Sanofi Genzyme to ensure continuity for the supply of fitusiran for ongoing clinical studies, and, at Sanofi Genzyme’s request, commercial sales. Sanofi Genzyme also has the right to manufacture fitusiran. Due to the uncertainty of pharmaceutical development and the high historical failure rates generally associated with drug development, we may not receive any additional milestone payments or any royalty payments from Sanofi Genzyme under the 2014 Sanofi Genzyme collaboration, as amended, or the AT3 License Terms. The 2014 Sanofi Genzyme collaboration, as amended, will continue to be governed by an alliance joint steering committee that is comprised of an equal number of representatives from each party. Additional committees manage various aspects of each regional and global program and oversee certain matters, including transition planning, that may arise under the Exclusive TTR License and the AT3 License Terms. As noted above, the Sanofi Genzyme collaboration originally entered into in 2012 was materially modified during its term when the agreement was amended in 2014, prior to our adoption of the new revenue standard on January 1, 2018. In accordance with the new revenue standard, we evaluated the Sanofi Genzyme collaboration with the aggregate effect of all modifications when identifying performance obligations, determining the transaction price and allocating the transaction price. We determined that certain promises included in these agreements are within the scope of the new revenue standard since Sanofi Genzyme is a customer with respect to the license of the rights to its territories. We also determined, however, that certain aspects of these agreements are within the scope of the collaboration accounting guidance with respect to co-commercialization activities as these activities are joint risk-sharing and are not reflective of a vendor-customer relationship. We apply the new revenue standard to all promises associated with the transfer of goods and services to a customer. We concluded that Sanofi Genzyme meets the definition of a customer as we are delivering intellectual property and know-how rights as well as research and development activities for the TTR programs and fitusiran programs in support of territories in which we are not jointly sharing the risks and rewards. We concluded that the accounting for the original 2014 Sanofi Genzyme collaboration, and the collaboration, as amended, should be assessed as separate contracts for (i) the patisiran and revusiran (TTR) programs, upon the initiation of the 2014 Sanofi Genzyme collaboration, and (ii) the subsequent opt-in by Sanofi Genzyme for the fitusiran program. In addition, we determined that the Sanofi Genzyme collaboration met the requirements to be accounted for as a contract, including that it is probable that we will collect the consideration to which we are entitled in exchange for the goods or services that will be delivered to Sanofi Genzyme. We identified contract promises or deliverables for licenses to our intellectual property and know-how rights, associated development activities, joint steering committee participation and information exchange. We determined that, pursuant to the new revenue standard (and consistent with our accounting prior to the adoption of the new revenue standard), the performance obligations were not separately identifiable and were not distinct (and did not have standalone value) due to the specialized nature of the services to be provided by us and the dependent relationship between the performance obligations. Given this fact pattern, we have concluded each of the TTR and fitusiran contracts have a single identified or combined performance obligation. When applying the previous revenue standard, we determined that the co-commercialization activities prior to the 2018 amendment were within the scope of the collaboration accounting standard since both parties would actively participate in the co-commercialization and be subject to significant risks and rewards. As a result of this determination, we recorded any payments or cash receipts for these joint risk-sharing activities as an adjustment to the related operations expense captions. The amounts recorded as a reduction of our selling, general and administrative activities were not material. The transaction price as of January 1, 2018 of $127.6 million for the 2014 Sanofi Genzyme collaboration related to the license to the TTR programs included the $22.5 million upfront payment and $11.0 million of development milestone payments earned under the now superseded 2012 Sanofi Genzyme agreement, a $25.0 million development milestone payment for revusiran achieved in 2014, the estimated patisiran and revusiran cost-share reimbursements of $63.6 million and $57.0 million, net of payments to Sanofi Genzyme, respectively, and the $51.5 million equity discount related to the stock purchase agreement, described below. Since the fair value of the stock at the time of closing was more than the consideration received by the Company by $51.5 million, we reduced the transaction price of the license and collaboration contract, treating the equity discount in a manner consistent with a payment to the customer. The transaction price related to our license to the fitusiran program as of January 1, 2018, accounted for as a separate agreement, included estimated fitusiran development cost-share reimbursements of $147.3 million, net of payments to Sanofi Genzyme. There are no refund provisions in the agreement and, therefore, none of the consideration received to date has been excluded from the transaction price calculation. None of the unearned milestones as of January 1, 2018 were included in the transaction price, as all unearned milestone amounts were determined to be fully constrained. We considered several factors, including that achievement of the milestones is outside our control and contingent upon success in clinical trials and regulatory decisions and the licensee’s efforts. Any consideration related to sales-based royalties (including milestones) will be recognized when the related sales occur as they were determined to relate predominantly to the license granted to Sanofi Genzyme and as a result have also been excluded from the transaction price. We will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur We allocated the transaction price to the combined performance obligation. We have determined that this combined performance obligation is satisfied over time based on our performance that is creating or enhancing an asset that Sanofi Genzyme controls. In this instance, Sanofi Genzyme received control over the asset, or the licensed intellectual property, and know-how, at the time the contract was executed since the licensed intellectual property and know-how meet the definition of functional intellectual property per the new revenue standard, which defines functional intellectual property as intellectual property that derives a substantial portion of its utility from its standalone functionality rather than the entity’s ongoing activities (thus, once the asset is fully developed, our ongoing involvement is not required for the licensee to derive value). The other promises included in the performance obligation, however, are enhancing the controlled asset, and thus the combined performance obligation is being satisfied over time. The new revenue standard requires a single method of measuring performance for each performance obligation satisfied over time. Since we do not have a reliable method of estimating progress based upon its outputs, it was determined that the most reliable method of estimating progress would be using a cost-to-cost input method. We have determined that our completion of certain clinical and regulatory development tasks is relevant and directly related to our progress in completing the combined performance obligation. As such, we measured our progress upon adoption and will continue to measure our progress during each reporting period based upon the amount of development costs incurred divided by the total amount of development costs expected to be incurred over the course of the agreement. We exclude costs that are not related to our completion of this performance obligation, such as the completion of tasks (and incurring of costs) associated with the marketing and commercialization of the drug. We estimated our internal costs during the last three years, excluding non-reimbursable costs that were not deemed to directly relate to the delivery of the development services to Sanofi Genzyme. Historically, we have been unable to reliably measure our performance based upon our lack of historical experience in completing the development of a drug candidate and have, as a result, defaulted to straight-line attribution for many of our licensing agreements. At the time of adoption of the new revenue standard, however, we have completed a substantial portion of our development obligations and determined we have sufficient information to estimate the remaining development costs for the fitusiran program and sufficient experience to reasonably estimate our development costs. We determined that the 2018 amendment, together with the Exclusive TTR License and the AT3 License Terms, referred to as the 2018 restructured agreement, are included in the scope of the modification provisions of the new revenue standard. We had identified that the agreement for the TTR programs under the 2014 Sanofi Genzyme collaboration should be accounted for separately from any subsequent option exercises, including with respect to fitusiran. Therefore, we concluded it is appropriate to account for the 2018 restructured agreement as two separate modifications to the 2014 Sanofi Genzyme collaboration: one related to the TTR programs and one related to the fitusiran program. Our conclusions related to scoping under the prior revenue standard are consistent with the new revenue standard. As noted above, the 2018 amendment, together with the Exclusive TTR License, provide us with the exclusive right to pursue the further global development and commercialization of all TTR products, including patisiran. We are responsible for all development and commercialization costs for patisiran and ALN-TTRsc02. As of the 2018 restructured agreement, we are no longer required to complete the delivery of any of the performance obligations under the agreement related to the TTR programs. As a result, the transaction price prior to the 2018 amendment has been reduced as we are no longer entitled to cost-share reimbursements or any of the previously constrained consideration, such as milestones and royalties. Since the 2018 amendment affected the transaction price but did not add any incremental and distinct performance obligations, we concluded this amendment should be accounted for as a change to the existing agreement and recorded the revenue on a cumulative catch-up basis. At the time of the 2018 amendment, we had $2.9 million in revenue deferred as a contract liability on our condensed consolidated balance sheet related to this contract for TTR programs, all of which we recognized in the first quarter of 2018 under the proportional performance model as we no longer expected to incur costs associated with the delivery of goods or services. If we had not adopted the new revenue standard, at the time of the 2018 restructured agreement, we would have had $25.8 million of deferred revenues on our condensed consolidated balance sheet that would have been recognized in full upon the date of the 2018 restructured agreement as we would have similarly concluded there were no ongoing deliverables under the 2018 restructured agreement related to the TTR programs. We expect to record future royalties payable to Sanofi Genzyme with respect to any sales of patisiran within cost of goods sold as Sanofi Genzyme is no longer considered our customer after the 2018 restructured agreement for sales of all TTR products, including patisiran, and as such, these royalty payments are outside of the scope of the new revenue standard, including with respect to principal versus agent guidance. The 2018 amendment, together with the AT3 License Terms, as noted above, provide Sanofi Genzyme the exclusive right to pursue the further global development and commercialization of fitusiran and any back-up products and terminates the previous co-development and co-commercialization rights related to fitusiran under the 2014 Sanofi Genzyme collaboration. The 2018 restructured agreement provides a broader license that permits global development, manufacturing and commercialization, and we are required to facilitate the transfer of all ongoing activities, contracts, intellectual property, know-how and other materials and information related to fitusiran to Sanofi Genzyme. In connection with the 2018 restructured agreement for fitusiran, we will fund development and commercialization costs for fitusiran through the transition period, which was substantially completed in the third quarter of 2018, up to a limit of $50.0 million. The only milestone under the 2018 restructured agreement, which was achieved in the first quarter of 2018 following the dosing of the first patient in the ATLAS Phase 3 program for fitusiran, is considered variable consideration for the license and transition services related to the fitusiran program. We have agreed to reimburse Sanofi Genzyme for certain transition activities that are reflected as a reduction in the transaction price. As a result, the transaction price has been reduced as we are no longer entitled to cost-share reimbursements or any of the previously constrained consideration, such as milestones and royalties. We concluded that the modification that resulted from the 2018 restructured agreement related to fitusiran would be treated as a termination and replacement of the 2014 Sanofi Genzyme collaboration and accounted for prospectively as the remaining license and transition services are considered distinct from that under the agreement prior to this modification. However, the incremental consideration under the 2018 restructured agreement does not directly reflect the standalone selling price of the incremental performance obligation. Therefore, we concluded the 2018 restructured agreement for fitusiran should be accounted for on a prospective basis. At the time of the 2018 amendment, we had $0.6 million in revenue deferred as a contract liability on our condensed consolidated balance sheet related to the 2014 Sanofi Genzyme collaboration for the fitusiran program. As of June 30, 2018, the transaction price of the 2018 restructured agreement for fitusiran is $40.8 million, primarily related to the $50.0 million milestone that was achieved in the first quarter of 2018. Consistent with our accounting prior to this 2018 modification, we are applying the sales-based royalty under the new revenue standard to exclude from the transaction price the royalties earned on Sanofi Genzyme’s sales of fitusiran as we have determined in the context of all the performance obligations, including those deliv |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 6 Months Ended |
Jun. 30, 2018 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE MEASUREMENTS | 3. FAIR VALUE MEASUREMENTS The following tables present information about our assets that are measured at fair value on a recurring basis at June 30, 2018 and December 31, 2017, and indicate the fair value hierarchy of the valuation techniques we utilized to determine such fair value, in thousands: Description At June 30, 2018 Quoted Prices in Active Markets (Level 1) Significant Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Cash equivalents: Certificates of deposit $ 5,000 $ — $ 5,000 $ — Commercial paper 3,700 — 3,700 — Corporate notes 2,000 — 2,000 — Money market funds 307,602 307,602 — — Marketable debt securities: Certificates of deposit 33,042 — 33,042 — Commercial paper 145,245 — 145,245 — Corporate notes 356,465 — 356,465 — U.S. government-sponsored enterprise securities 261,774 — 261,774 — U.S. treasury securities 277,639 — 277,639 — Marketable equity securities 12,044 12,044 — — Restricted cash (money market funds) 1,474 1,474 — — Total $ 1,405,985 $ 321,120 $ 1,084,865 $ — Description At December 31, 2017 Quoted Prices in Active Markets (Level 1) Significant Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Cash equivalents: Commercial paper $ 82,262 $ — $ 82,262 $ — Corporate notes 18,116 — 18,116 — U.S. government-sponsored enterprise securities 231,122 — 231,122 — U.S. treasury securities 62,855 — 62,855 — Money market funds 122,986 122,986 — — Marketable debt securities: Certificates of deposit 30,200 — 30,200 — Commercial paper 56,951 — 56,951 — Corporate notes 373,252 — 373,252 — U.S. government-sponsored enterprise securities 398,298 — 398,298 — U.S. treasury securities 200,475 — 200,475 — Restricted cash (money market funds) 1,471 1,471 — — Total $ 1,577,988 $ 124,457 $ 1,453,531 $ — During the six months ended June 30, 2018 and 2017, there were no transfers between Level 1 and Level 2 financial assets. The carrying amounts reflected in our condensed consolidated balance sheets for cash, billed and unbilled collaboration receivables, other current assets, accounts payable and accrued expenses approximate fair value due to their short-term maturities. As of June 30, 2018, we had $8.7 million included in long-term other assets on our condensed consolidated balance sheet that represents the discounted present value, based on a Level 2 fair value measurement, of the $13.0 million cash payment due from Dicerna by April 18, 2022 under the terms of the Settlement Agreement, described more fully above at Note 1. We are accounting for this receivable as a transaction between two parties and imputing the interest through interest income on our condensed consolidated statements of comprehensive loss. To determine the present value of this receivable, we used an interest rate of 11 percent as of the settlement date for a note that would have resulted if an independent borrower and independent lender had negotiated a similar transaction. The fair value of our long-term debt at , computed pursuant to a discounted cash flow technique using a market interest rate, was $30.1 million and is considered a Level 3 fair value measurement. The effective interest rate reflects the current market rate. |
MARKETABLE DEBT SECURITIES
MARKETABLE DEBT SECURITIES | 6 Months Ended |
Jun. 30, 2018 | |
Investments In Marketable Debt Securities [Abstract] | |
MARKETABLE DEBT SECURITIES | 4. MARKETABLE DEBT SECURITIES We obtain fair value measurement data for our marketable debt securities from independent pricing services. We perform validation procedures to ensure the reasonableness of this data. This includes meeting with the independent pricing services to understand the methods and data sources used. Additionally, we perform our own review of prices received from the independent pricing services by comparing these prices to other sources and confirming those securities are trading in active markets. The following tables summarize our marketable debt securities at June 30, 2018 and December 31, 2017, in thousands: At June 30, 2018 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Certificates of deposit $ 33,042 $ — $ — $ 33,042 Commercial paper 145,245 — — 145,245 Corporate notes 356,938 7 (480 ) 356,465 U.S. government-sponsored enterprise securities 262,109 — (335 ) 261,774 U.S. treasury securities 277,846 — (207 ) 277,639 Total $ 1,075,180 $ 7 $ (1,022 ) $ 1,074,165 At December 31, 2017 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Certificates of deposit $ 30,200 $ — $ — $ 30,200 Commercial paper 56,951 — — 56,951 Corporate notes 373,736 11 (495 ) 373,252 U.S. government-sponsored enterprise securities 399,281 — (983 ) 398,298 U.S. treasury securities 200,649 1 (175 ) 200,475 Total $ 1,060,817 $ 12 $ (1,653 ) $ 1,059,176 We classify our debt security investments based on their contractual maturity dates. The following table summarizes our available-for-sale debt securities by contractual maturity, at June 30, 2018, in thousands: At June 30, 2018 Amortized Fair Value Less than one year $ 1,075,180 $ 1,074,165 Greater than one year but less than two years — — Total $ 1,075,180 $ 1,074,165 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 6 Months Ended |
Jun. 30, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | 5. COMMITMENTS AND CONTINGENCIES Manufacturing Facility In April 2016, we purchased 12 acres of undeveloped land in Norton, Massachusetts. We are constructing a manufacturing facility at this site for drug substance, including small interfering RNAs, or siRNAs, and siRNA conjugates, for clinical and commercial use. At June 30, 2018 and December 31, 2017, property, plant and equipment, net, on our condensed consolidated balance sheets reflects $177.8 million and $140.5 million, respectively, of land and associated costs related to the construction of our drug substance manufacturing facility. Credit Agreements On April 29, 2016, we entered into (i) a Credit Agreement, or the BOA Credit Agreement, with Alnylam U.S., Inc., our wholly-owned subsidiary, as the borrower, us, as a guarantor, and Bank of America N.A., or BOA, as the lender and (ii) a Credit Agreement, or the Wells Credit Agreement, together with the BOA Credit Agreement, the Credit Agreements, by and among Alnylam U.S., Inc., as the borrower, us, as a guarantor, and Wells Fargo Bank, National Association, or Wells, as the lender. The Credit Agreements were entered into in connection with the planned build out of our new drug substance manufacturing facility. The BOA Credit Agreement provided for a $120.0 million term loan facility and was scheduled to mature on April 29, 2021. In December 2017, we repaid in full the $120.0 million outstanding principal amount under the BOA Credit Agreement and the BOA Credit Agreement terminated in accordance with its terms upon repayment of the outstanding indebtedness. The Wells Credit Agreement provides for a $30.0 million term loan facility and matures on April 29, 2021. The proceeds of the borrowing under the BOA Credit Agreement were, and under the Wells Credit Agreement are, to be used for working capital and general corporate purposes. Interest on borrowings under the BOA Credit Agreement was, and under the Wells Credit Agreement is calculated based on LIBOR plus 0.45 percent, except in the event of default. The borrower may prepay loans under the Wells Credit Agreement at any time, without premium or penalty, subject to certain notice requirements and LIBOR breakage costs. The obligations of the borrower and us under the BOA Credit Agreement were, and under the Wells Credit Agreement are secured by cash collateral in an amount equal to, at any given time, at least 100 percent of the principal amount of all term loans outstanding under such Credit Agreement at such time. At each of June 30, 2018 and December 31, 2017, we have recorded $30.0 million of cash collateral in connection with the Wells Credit Agreement as restricted investments on our condensed consolidated balance sheets. The Wells Credit Agreement contains limited representations and warranties and limited affirmative and negative covenants, including quarterly reporting obligations, as well as certain customary events of default. Litigation From time to time, we are a party to legal proceedings in the course of our business, including the matters described below. The claims and legal proceedings in which we could be involved include challenges to the scope, validity or enforceability of patents relating to our product candidates, and challenges by us to the scope, validity or enforceability of the patents held by others. These include claims by third parties that we infringe their patents. The outcome of any such legal proceedings, regardless of the merits, is inherently uncertain. In addition, litigation and related matters are costly and may divert the attention of our management and other resources that would otherwise be engaged in other activities. If we were unable to prevail in any such legal proceedings, our business, results of operations, liquidity and financial condition could be adversely affected Silence Litigation In October 2017, Silence Therapeutics plc, or Silence, served its previously announced claim in the High Court of England and Wales, or the High Court, issued in the name of Silence Therapeutics GmbH against Alnylam UK Ltd., Alnylam Pharmaceuticals, Inc., and The Medicines Company UK Ltd, referred to collectively as the Defendants. The claim seeks a declaration that patisiran, fitusiran, givosiran and inclisiran, together, the Products, are protected by Silence’s European Patent No. 2 258 847, referred to as the ‘847 patent, within the meaning of the Supplementary Protection Certificate, or SPC, Regulation of the European Union. The claim alleges that any marketing authorization for any of these Products granted to any of the Defendants is a valid authorization within the meaning of the SPC Regulation, to support an application for an SPC by Silence for each of the Products, allegedly allowing Silence to extend the expiration date of its ‘847 patent on a Product-by-Product basis, based on the amount of time in regulatory review for each of the Products, again on a Product-by-Product basis, up to a statutory maximum. In addition, Silence is seeking costs, interest and other unspecified relief. In November 2017, the Defendants submitted substantive defenses to the claim. In October 2017, we, through our affiliate Alnylam UK Ltd., and The Medicines Company UK Ltd filed and served a claim against Silence Therapeutics GmbH and Silence in the High Court seeking revocation of the ‘847 patent, as well as a declaration of non-infringement by each of the Products of the ‘847 patent, and costs and interest among other potential remedies. In November 2017, Silence filed a defense to our claim along with counter claims alleging infringement of the ‘847 patent by our Products. The High Court has set a trial date of December 3, 2018 for all claims between Silence and the Defendants. In December 2017, we filed an opposition with the European Patent Office seeking revocation of the ‘847 patent in its entirety. Although we believe the ‘847 patent is invalid and not infringed by our Products and that, therefore, Silence would not be entitled to obtain an SPC based on any of our Products, litigation and opposition proceedings are subject to inherent uncertainty, as noted above, and a court or patent office could ultimately rule against us or find that Silence’s patents are valid. In March 2018, we filed an action against Silence in the United States District Court for the District of Massachusetts seeking a declaratory judgement of non-infringement by patisiran of Silence U.S. Patent Nos: 7,893,245; 8,324,370; 8,933,215; 9,222,092; and 9,695,423, referred to as the DJ Action. In June 2018, Silence filed a motion to dismiss the DJ Action alleging lack of personal jurisdiction over Silence in Massachusetts as well as lack of subject matter jurisdiction, given that patisiran had not yet received a marketing approval in the U.S. In response, we filed an amended complaint and have sought leave of the Court to file a second amended complaint adding certain facts not included in the initial complaint to further establish personal jurisdiction in Massachusetts for Silence. On July 20, 2018, Silence filed a motion to dismiss our first amended complaint. On July 25, 2018, we filed a request to withdraw certain confidential information filed under seal from our second amended complaint. Between April and July 2018, we filed petitions for Post Grant Review of five Silence granted U.S. Patents with the U.S. Patent and Trademark Office seeking a cancellation of all claims as being unpatentable under 35 U.S.C. §§ 112 and 102. In April 2018, Silence amended its claim in the High Court further alleging that patisiran and fitusiran infringe its recently granted patent EP 1 857 547, referred to as the ‘547 patent, and seeking an injunction as well as monetary damages based on such alleged infringement. On April 23, 2018, Silence served patent infringement proceedings against us in Portugal alleging that patisiran infringes the ‘547 patent. Silence is seeking a permanent injunction against the commercialization of patisiran in Portugal. On June 29, 2018, Silence filed a Notice of Discontinuance with the High Court to withdraw its original claim alleging it is entitled to an SPC for the Products, as well as its claims alleging infringement by the Products of the ‘847 patent as granted and its claim of infringement against patisiran and fitusiran of the ‘547 patent as granted. In addition, Silence filed an unconditional amendment to both its ‘847 and ‘547 patents narrowing their claim scope in the United Kingdom from the claims as granted, and has claimed infringement by patisiran of the ‘547 patent as amended in the United Kingdom. We believe the ‘847 and ‘547 patents as originally filed and as amended were and are invalid and not infringed by any of our products and will defend against any claim of infringement brought against any of our products including the present claim of infringement by patisiran of the ‘547 patent as amended. We intend to file an opposition with the European Patent Office seeking to revoke the ‘547 patent in its entirety. Dicerna Litigation On June 10, 2015, we filed a trade secret misappropriation lawsuit against Dicerna in the Superior Court of Middlesex County, Massachusetts seeking to stop misappropriation by Dicerna of our confidential, proprietary and trade secret information related to the RNAi assets we purchased from Merck, including certain N-acetylgalactosamine, or GalNAc, conjugate technology. In addition to permanent injunctive relief, we were also seeking monetary damages from Dicerna. In August 2017, Dicerna successfully added counterclaims against us in the trade secret lawsuit alleging that our lawsuit represented abuse of process and claiming tortious interference with its business. In September 2017, we filed a motion to dismiss Dicerna’s counterclaims, which motion was denied. In addition, in August 2017, Dicerna filed a lawsuit against us in the United States District Court of Massachusetts alleging attempted monopolization by us under the Sherman Antitrust Act. In October 2017, we filed a motion to dismiss the antitrust lawsuit. On April 18, 2018, we and Dicerna entered into a Settlement Agreement resolving all ongoing litigation between the companies. The terms of the Settlement Agreement include mutual releases and dismissal with prejudice of all claims and counterclaims in the following litigation between the parties: (i) Alnylam Pharmaceuticals, Inc. v. Dicerna Pharmaceuticals, Inc. Dicerna Pharmaceuticals, Inc. v. Alnylam Pharmaceuticals, Inc. Under the terms of the Settlement Agreement, Dicerna will pay us an aggregate of $25.0 million, including an upfront cash payment of $2.0 million and 983,208 shares of Dicerna common stock, valued at $10.0 million, that were received in the second quarter of 2018, and an additional $13.0 million over the next four years, the timing of which will be dependent upon revenue Dicerna receives pursuant to future partnerships and collaborations related to Ga1NAc-conjugated RNAi research and development, provided that such additional amount must be paid by no later than April 18, 2022. In addition, Dicerna will be restricted in its development and other activities relating to oligonucleotide-based therapeutics directed toward a defined set of targets, for periods ranging from 18 months up to four years. The Settlement Agreement does not include any license to our GalNAc conjugate intellectual property or any licenses to any other intellectual property from either party. Nor does the Settlement Agreement include any admission of liability or wrongdoing by either company. |
INCOME TAXES
INCOME TAXES | 6 Months Ended |
Jun. 30, 2018 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | 6. INCOME TAXES For the three months ended June 30, 2018, we recorded a provision for income taxes of $79,000 due to foreign income taxes recorded during the second quarter of 2018. For the six months ended June 30, 2018, we recorded a net provision for income taxes of $17,000 due to foreign income taxes recorded during the first and second quarters of 2018 primarily offset by a $0.8 million benefit for refundable credits related to the TCJA. Our preliminary estimate of the TCJA and the remeasurement of our deferred tax assets and liabilities is subject to the finalization of management’s analysis related to certain matters, such as developing interpretations of the provisions of the TCJA, changes to certain estimates and the filing of our tax returns. U.S. Treasury regulations, administrative interpretations or court decisions interpreting the TCJA may require further adjustments and changes in our estimates. The final determination of the TCJA and the remeasurement of our deferred assets and liabilities will be completed as additional information becomes available, but no later than one year from the enactment of the TCJA. For the six months ended June 30, 2018, there were no changes to management’s analysis originally performed as of December 31, 2017. |
SUMMARY OF SIGNIFICANT ACCOUN14
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 6 Months Ended |
Jun. 30, 2018 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Principles of Consolidation | Basis of Presentation and Principles of Consolidation The accompanying condensed consolidated financial statements of Alnylam Pharmaceuticals, Inc. are unaudited and have been prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP, applicable to interim periods and, in the opinion of management, include all normal and recurring adjustments that are necessary to state fairly the results of operations for the reported periods. Our condensed consolidated financial statements have also been prepared on a basis substantially consistent with, and should be read in conjunction with, our audited consolidated financial statements for the year ended December 31, 2017, which were included in our Annual Report on Form 10-K that was filed with the Securities and Exchange Commission, or SEC, on February 15, 2018. The year-end condensed consolidated balance sheet data was derived from our audited financial statements, but does not include all disclosures required by GAAP. The results of our operations for any interim period are not necessarily indicative of the results of our operations for any other interim period or for a full fiscal year. The accompanying condensed consolidated financial statements reflect the operations of Alnylam and our wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with 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 condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. |
Liquidity | Liquidity Based on our current operating plan, we believe that our cash, cash equivalents and marketable debt securities at June 30, 2018, together with the cash we expect to generate under our current alliances, will be sufficient to enable us to advance our Alnylam 2020 |
Net Loss Per Common Share | Net Loss Per Common Share We compute basic net loss per common share by dividing net loss by the weighted-average number of common shares outstanding. We compute diluted net loss per common share by dividing net loss by the weighted-average number of common shares and dilutive potential common share equivalents then outstanding. Potential common shares consist of shares issuable upon the exercise of stock options (the proceeds of which are then assumed to have been used to repurchase outstanding shares using the treasury stock method). Because the inclusion of potential common shares would be anti-dilutive for all periods presented, diluted net loss per common share is the same as basic net loss per common share. The following table sets forth for the periods presented the potential common shares (prior to consideration of the treasury stock method) excluded from the calculation of net loss per common share because their inclusion would be anti-dilutive, in thousands: At June 30, 2018 2017 Options to purchase common stock 12,794 12,372 Unvested restricted common stock 150 172 12,944 12,544 |
Public Offering | Public Offering In May 2017, we sold an aggregate of 5,000,000 shares of our common stock through an underwritten public offering at a price to the public of $71.87 per share. As a result of the offering, we received aggregate net proceeds of $355.2 million after deducting underwriting discounts and commissions and other offering expenses of $4.2 million. |
Equity | Equity Total stockholders’ equity at June 30, 2018 decreased by $145.6 million compared to December 31, 2017. This decrease was related primarily to our net loss, partially offset during the six months ended June 30, 2018 by an adjustment to the opening balance of our accumulated deficit related to the adoption of the new revenue standard on January 1, 2018, described below under the heading “Recent Accounting Pronouncements,” as well as increases to additional paid-in capital due to proceeds from the exercise of stock options and stock-based compensation. |
Fair Value Measurements | Fair Value Measurements The fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. 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 data points that are observable, such as quoted prices (adjusted), interest rates and yield curves. Fair values determined by Level 3 inputs utilize unobservable data points for the asset or liability, and include situations where there is little, if any, market activity for the asset or liability. The fair value hierarchy level is determined by the lowest level of significant input. |
Investments in Marketable Securities and Cash Equivalents | Investments in Marketable Securities and Cash Equivalents We invest our excess cash balances in short-term and long-term marketable debt securities. We classify our investments in marketable debt securities as either held-to-maturity or available-for-sale based on facts and circumstances present at the time we purchased the securities. At each balance sheet date presented, we classified all of our investments in debt securities as available-for-sale. We report available-for-sale debt securities at fair value at each balance sheet date and include any unrealized holding gains and losses (the adjustment to fair value) in accumulated other comprehensive income (loss), a component of stockholders’ equity. At June 30, 2018, the balance in our accumulated other comprehensive loss was composed solely of activity related to our marketable debt securities and our investment in equity securities of Regulus Therapeutics Inc., or Regulus. Realized gains and losses are determined using the specific identification method and are included in other income (expense). We did not recognize any realized gains or losses from sales of our available-for-sale debt securities during the six months ended June 30, 2018 or 2017, and as a result, did not reclassify any amount out of accumulated other comprehensive loss for the respective period related to our available-for-sale debt securities. If any adjustment to fair value reflects a decline in the value of the marketable debt securities, we consider all available evidence to evaluate the extent to which the decline is “other than temporary,” including our intention to sell and, if so, mark the investment to market through a charge to our condensed consolidated statements of comprehensive loss. We did not record any impairment charges related to our marketable debt securities during the six months ended June 30, 2018 or 2017. Our marketable debt securities are classified as cash equivalents if the original maturity, from the date of purchase, is 90 days or less, and as marketable debt securities if the original maturity, from the date of purchase, is in excess of 90 days. Our cash equivalents are composed of certificates of deposit, commercial paper, corporate notes, U.S. government-sponsored enterprise securities, U.S. treasury securities and money market funds. Upon the adoption of the new accounting standard, discussed below under the heading “Recent Accounting Pronouncements,” effective January 1, 2018, we measure marketable equity investments (except those accounted for under the equity method of accounting or those that result in consolidation of an investee), which have readily available prices, at fair value with changes in fair value recognized in other income (expense) on our condensed consolidated statements of comprehensive loss 983,208 shares of Dicerna Pharmaceuticals, Inc., or Dicerna, common stock that we received under a Settlement Agreement and General Release entered into in April 2018, referred to as the Settlement Agreement, described more fully below at Note 5. During the second quarter of 2017, we sold all our remaining holdings in Regulus. We accounted for our investment in Regulus as an available-for-sale marketable equity security. We recognized $0.3 million and $1.9 million of realized losses from sales of our Regulus available-for-sale securities as other expense in our condensed consolidated statement of comprehensive loss during the three and six months ended June 30, 2017, respectively. Intraperiod tax allocation rules require us to allocate our provision for income taxes between continuing operations and other categories of earnings, such as other comprehensive income. In periods in which we have a year-to-date pre-tax loss from continuing operations and pre-tax income in other categories of earnings, such as other comprehensive income, we must allocate the tax provision to the other categories of earnings. We then record a related tax benefit in continuing operations. Upon sales of our marketable equity securities, we apply the aggregate portfolio approach to recognize the related tax provision or benefit into income (loss) from continuing operations. As a result, the disproportionate tax effect remains in accumulated other comprehensive income (loss) as long as we maintain an investment portfolio. At June 30, 2018 and December 31, 2017, there was $32.8 million of accumulated other comprehensive loss, net of tax, recorded on our condensed consolidated balance sheets related to our investment in Regulus. |
Revenue Recognition | Revenue Recognition We have entered into collaboration agreements with leading pharmaceutical and life sciences companies, including Sanofi Genzyme, the specialty care global business unit of Sanofi, and The Medicines Company, or MDCO. The terms of our collaboration agreements may include consideration such as non-refundable license fees, funding of research and development services, payments due upon the achievement of clinical and pre-clinical performance-based development milestones, regulatory milestones, manufacturing services, sales-based milestones and royalties on product sales. On January 1, 2018, we adopted the new revenue standard, discussed below under the heading “Recent Accounting Pronouncements,” which amended revenue recognition principles and provides a single, comprehensive set of criteria for revenue recognition within and across all industries. Our adoption of the new revenue standard had a material impact on our condensed consolidated financial statements, as discussed below under the heading “Recent Accounting Pronouncements.” This new revenue standard applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. The new revenue standard provides a five-step framework whereby revenue is recognized when control of promised goods or services is transferred to a customer at an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. To determine revenue recognition for arrangements that we determine are within the scope of the new revenue standard, we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy a performance obligation. We only apply the five-step model to contracts when collectability of the consideration to which we are entitled in exchange for the goods or services we transfer to the customer is determined to be probable. At contract inception, once the contract is determined to be within the scope of the new revenue standard, we assess whether the goods or services promised within each contract are distinct and, therefore, represent a separate performance obligation. Goods and services that are determined not to be distinct are combined with other promised goods and services until a distinct bundle is identified. We then allocate the transaction price (the amount of consideration we expect to be entitled to from a customer in exchange for the promised goods or services) to each performance obligation and recognize the associated revenue when (or as) each performance obligation is satisfied. Our estimate of the transaction price for each contract includes all variable consideration to which we expect to be entitled. We recognize the transaction price allocated to upfront license payments as revenue upon delivery of the license to the customer and resulting ability of the customer to use and benefit from the license, if the license is determined to be distinct from the other performance obligations identified in the contract. we utilize judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied (i) at a point in time, but only for licenses determined to be distinct from other performance obligations in the contract, or (ii) over time; and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from license payments. We evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition. Many of our collaboration agreements entitle us to additional payments upon the achievement of performance-based milestones. These milestones are generally categorized into three types: development milestones, generally based on the advancement of our pipeline and initiation of clinical trials; regulatory milestones, generally based on the submission, filing or approval of regulatory applications such as a New Drug Application, or NDA, in the United States; and sales-based milestones, generally based on meeting specific thresholds of sales in certain geographic areas. For each collaboration that includes development milestone payments, we evaluate whether it is probable that the consideration associated with each milestone will not be subject to a significant reversal in the cumulative amount of revenue recognized. Amounts that meet this threshold are included in the transaction price using the most likely amount method, whereas amounts that do not meet this threshold are considered constrained and excluded from the transaction price until they meet this threshold. At the end of each subsequent reporting period, we re-evaluate the probability of a significant reversal of the cumulative revenue recognized for our milestones, and, if necessary, adjust our estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues from collaborators and loss in the period of adjustment. have not recognized any royalty revenue resulting from any of our agreements. The new revenue standard requires us to allocate the arrangement consideration on a relative standalone selling price basis for each performance obligation after determining the transaction price of the contract and identifying the performance obligations to which that amount should be allocated. The relative standalone selling price is defined in the new revenue standard as the price at which an entity would sell a promised good or service separately to a customer. If other observable transactions in which we have sold the same performance obligation separately are not available, we are required to estimate the standalone selling price of each performance obligation. Key assumptions to determine the standalone selling price may include forecasted revenues, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical and regulatory success. Whenever we determine that a contract should be accounted for as a combined performance obligation over time, we determine the period over which the performance obligations will be performed and revenue will be recognized. Revenue is recognized using the proportional performance method. Direct labor hours or full-time equivalents are typically used as the measure of performance. Significant management judgment is required in determining the level of effort required under an arrangement and the period over which we are expected to complete our performance obligations under an arrangement. We evaluate our collaborative agreements for proper classification in our consolidated statements of comprehensive loss based on the nature of the underlying activity. Transactions between collaborators recorded in our consolidated statements of comprehensive loss are recorded on either a gross or net basis, depending on the characteristics of the collaborative relationship. We generally reflect amounts due under our collaborative agreements related to cost-sharing of development activities as revenue if we have a vendor-customer relationship with our collaborator. Costs incurred or shared with our collaboration partners that are deemed to be joint-risk sharing activities are recorded as an adjustment to the related operating expense captions. For revenue generating arrangements where we, as a vendor, provide consideration to a licensor or collaborator, as a customer, we apply the accounting standard that governs such transactions. This standard addresses the accounting for revenue arrangements where both the vendor and the customer make cash payments to each other for services and/or products. A payment to a customer is presumed to be a reduction of the transaction price unless we receive an identifiable benefit for the payment and we can reasonably estimate the fair value of the benefit received. Payments to a customer that are deemed a reduction of the transaction price are recorded first as a reduction of revenue, to the extent of both cumulative revenue recorded to date and probable future revenues, which include any unamortized deferred revenue balances, under all arrangements with such customer, and then as an expense. Payments that are not deemed to be a reduction of the transaction price are recorded as an expense. Consideration that does not meet the requirements to satisfy the above revenue recognition criteria is recorded as deferred revenue in the accompanying condensed consolidated balance sheets. Although we follow detailed guidelines in measuring revenue, certain judgments affect the application of our revenue policy. For example, in connection with our existing collaboration agreements, we have recorded on our condensed consolidated balance sheets short-term and long-term deferred revenue based on our best estimate of when such revenue will be recognized. Short-term deferred revenue consists of amounts that are expected to be recognized as revenue in the next 12 months. Amounts that we expect will not be recognized within the next 12 months are classified as long-term deferred revenue. However, this estimate is based on our current operating plan and, if our operating plan should change in the future, we may recognize a different amount of deferred revenue over the next 12-month period. The estimate of deferred revenue also reflects management’s estimate of the periods of our involvement in certain of our collaborations. Our performance obligations under these collaborations consist of participation on steering committees and the performance of other research and development services. In certain instances, the timing of satisfying these obligations can be difficult to estimate. Accordingly, our estimates may change in the future. Such changes to estimates would result in a change in revenue recognition amounts. If these estimates and judgments change over the course of these agreements, it may affect the timing and amount of revenue that we recognize and record in future periods. At June 30, 2018, we had short-term and long-term deferred revenue of $9.2 million and $4.5 million, respectively, related to our collaborations. Amounts are recorded as accounts receivable when our right to consideration is unconditional. We do not assess whether a contract has a significant financing component if the expectation at contract inception is that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less. We expense incremental costs of obtaining a contract as and when incurred if the expected amortization period of the asset that we would have recognized is one year or less or the amount is immaterial. At June 30, 2018, we have not capitalized any costs to obtain any of our contracts. |
Other income | Other Income As described more fully below at Note 5, |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board, or FASB, issued a new revenue recognition standard, which we refer to as the new revenue standard, which amends revenue recognition principles and provides a single, comprehensive set of criteria for revenue recognition within and across all industries. The new revenue standard provides a five-step framework whereby revenue is recognized when control of promised goods or services are transferred to a customer at an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The new revenue standard also requires enhanced disclosures pertaining to revenue recognition in both interim and annual periods. In August 2015, the FASB deferred the effective date of the new revenue standard from January 1, 2017 to January 1, 2018. In March 2016, the FASB issued amendments to clarify the implementation standard on principal versus agent considerations. In April 2016, the FASB issued amendments to clarify the standard on accounting for licenses of intellectual property and identifying performance obligations. In May 2016, the FASB issued amendments related to collectibility, non-cash consideration, the presentation of sales and other similar taxes collected from customers and transition. The new revenue standard allows for adoption using a full retrospective method or a modified retrospective method. On January 1, 2018, we adopted the new revenue standard by applying the modified retrospective method to all contracts that were not completed as of January 1, 2018. As a result, while reporting periods beginning on our adoption of the new revenue standard are presented under the new revenue standard, prior period amounts have not been adjusted and continue to be presented under the revenue standard in effect prior to January 1, 2018. For contracts that were modified prior to our adoption of the new revenue standard, we reflected the aggregate effect of all modifications that occurred before the beginning of the earliest period presented when identifying performance obligations and allocating the transaction price in accordance with an available practical expedient. Our implementation approach included performing a detailed review of our collaboration agreements not completed as of the transition date. In addition, we designed internal controls to enable the preparation of financial information and have reached conclusions on key accounting assessments related to the new revenue standard, including our assessment that the impact of accounting for costs incurred to obtain a contract is immaterial. There was no impact to cash from or used in operating, financing or investing activities on our condensed consolidated statement of cash flows as a result of the adoption of the new revenue standard. The following table summarizes the cumulative effect to our condensed consolidated balance sheet upon the adoption of the new revenue standard on January 1, 2018, in thousands: Condensed Consolidated Balance Sheet Balance at December 31, 2017 Adjustments Balance at January 1, 2018 Deferred revenue, current portion $ 41,705 $ (34,463 ) $ 7,242 Deferred revenue, net of current portion $ 43,075 $ (33,747 ) $ 9,328 Accumulated deficit $ (2,147,685 ) $ 68,210 $ (2,079,475 ) The adoption of the new revenue standard resulted in a cumulative reduction of $68.2 million of deferred revenue with a corresponding adjustment to the opening balance of accumulated deficit recorded in the first quarter of 2018. This adjustment is due primarily to the application of the new revenue standard to our collaboration agreements with Sanofi Genzyme, MDCO and Kyowa Hakko Kirin Co., Ltd., or A substantial portion of the incremental $68.2 million adjustment is the result of the application of the new revenue standard regarding how entities should measure progress in satisfying performance obligations and the contract’s transaction price. In particular, for Sanofi Genzyme and MDCO, the adoption of the new revenue standard resulted in the recognition of previously deferred revenue of $45.7 million and $4.5 million, respectively, due to the change in the way we measure our performance under each agreement, from a straight-line method to a proportional performance model. As a result, at January 1, 2018, the balance of remaining deferred revenues was $3.5 million and $1.2 million, respectively, related to Sanofi Genzyme and MDCO. In addition, the adoption of the new revenue standard resulted in the recognition of $15.5 million of previously deferred revenue related to our Kyowa Hakko Kirin we had been unable to reasonably estimate our period of performance under the Kyowa Hakko Kirin agreement as we were unable to estimate the timeline of our deliverables related to the fixed-price option granted to Kyowa Hakko Kirin for any additional compounds, an obligation that was bundled with all other deliverables into a single unit of accounting. Under the new revenue standard, two distinct performance obligations were identified. The first distinct performance obligation included a license to our program targeting respiratory syncytial virus, or RSV, infection , related know-how and updates, manufacturing supply services and joint steering committee services. The second distinct performance obligation included the fixed-price option to a future follow-on compound. We allocated all consideration to the first performance obligation because the second performance obligation was deemed to have a de minimis relative selling price due to its low likelihood of occurring, in part due to our discontinuation of our RSV program. Given this fact pattern, because we do not expect to incur any future costs related to our RSV program, we concluded our performance obligations were complete in the period prior to our adoption of the new revenue standard and therefore, there would not be a future significant reversal of revenue. As a result, we recorded the $15.5 million of deferred revenue as of December 31, 2017 as an adjustment to the opening balance of our accumulated deficit on January 1, 2018. In accordance with the new revenue standard requirements, the following tables summarize the impact of adoption on our condensed consolidated balance sheet and condensed consolidated statement of comprehensive loss, in thousands: At June 30, 2018 Condensed Consolidated Balance Sheet As Reported Balances Without Adoption of New Revenue Standard Effect of Change Higher/(Lower) Deferred revenue, current portion $ 9,161 $ 9,860 $ (699 ) Deferred revenue, net of current portion $ 4,522 $ 22,514 $ (17,992 ) Accumulated deficit $ (2,384,249 ) $ (2,403,024 ) $ (18,775 ) Three Months Ended June 30, 2018 Condensed Consolidated Statement of Comprehensive Loss As Reported Balances Without Adoption of New Revenue Standard Effect of Change Higher/(Lower) Net revenues from collaborators $ 29,907 $ 46,215 $ (16,308 ) Net loss $ (163,560 ) $ (147,252 ) $ 16,308 Net loss per common share - basic and diluted $ (1.63 ) $ (1.46 ) $ 0.17 Six Months Ended June 30, 2018 Condensed Consolidated Statement of Comprehensive Loss As Reported Balances Without Adoption of New Revenue Standard Effect of Change Higher/(Lower) Net revenues from collaborators $ 51,806 $ 101,241 $ (49,435 ) Net loss $ (304,774 ) $ (255,339 ) $ 49,435 Net loss per common share - basic and diluted $ (3.04 ) $ (2.55 ) $ 0.49 In addition to the reduction to deferred revenues recorded and corresponding offset to the accumulated deficit described above, on January 6, 2018, we and Sanofi Genzyme entered into an amendment to our 2014 Sanofi Genzyme collaboration. In connection and simultaneously with entering into the amendment to the 2014 Sanofi Genzyme collaboration, we and Sanofi Genzyme also entered into an Exclusive License Agreement with respect to all TTR products, including patisiran, ALN-TTRsc02 and any back-up products, referred to as the Exclusive TTR License, and the ALN-AT3 Global License Terms with respect to fitusiran and any back-up products, referred to as the AT3 License Terms. In January 2016, the FASB issued a new standard on recognition and measurement of financial assets and financial liabilities. The new standard impacts the accounting for equity investments, financial liabilities under the fair value option, and the presentation and disclosure requirements for financial instruments. All equity investments in unconsolidated entities (other than those accounted for under the equity method of accounting) will generally be measured at fair value with changes in fair value recognized through earnings. There is no longer an available-for-sale classification (changes in fair value reported in other comprehensive income (loss)) for equity securities with readily determinable fair values. For equity investments that do not have readily determinable fair values, such as privately issued corporate equity securities, we have elected the measurement alternative. As a result, we will record these investments at cost, less any impairment, and adjust for observable price changes in orderly transactions for identical or similar investments of the same issuer. At June 30, 2018 and December 31, 2017, we did not have material equity investments without readily determinable fair values. In addition, the FASB clarified the need for a valuation allowance on deferred tax assets resulting from unrealized losses on available-for-sale debt securities. In general, the new standard requires modified retrospective application to all outstanding instruments, with a cumulative effect adjustment recorded to opening retained earnings. This standard became effective for us on January 1, 2018. This standard had an impact on our condensed consolidated financial statements and related disclosures beginning in the second quarter of 2018 as a result of the 983,208 shares of common stock of Dicerna, a publicly traded company, that we received in April 2018, described more fully above. During the three and six months ended June 30, 2018, we recorded an unrealized gain of $2.0 million for the change in the fair value of such shares of Dicerna common stock as other income on our condensed consolidated statements of comprehensive loss as a result of the application of this new standard. In February 2016, the FASB issued a new leasing standard that requires that all lessees recognize the assets and liabilities that arise from leases on the condensed consolidated balance sheet and disclose qualitative and quantitative information about its leasing arrangements. The new standard will be effective for us on January 1, 2019. Early adoption is permitted. We are currently evaluating the timing of our adoption and the expected impact that this standard could have on our condensed consolidated financial statements and related disclosures. In November 2016, the FASB issued a new standard that requires restricted cash and restricted cash equivalents be included with cash and cash equivalents when reconciling the total beginning and ending amounts for the periods shown on the condensed consolidated statements of cash flows. The new standard became effective for us on January 1, 2018 using a retrospective transition method for each period presented. For the years ended December 31, 2017 and 2016, our restricted cash and restricted cash equivalents were not significant. This standard did not have a significant impact on our condensed consolidated financial statements and related disclosures. In March 2017, the FASB issued a new standard that amends the amortization period for certain purchased callable debt securities held at a premium by shortening the amortization period for the premium to the earliest call date. The new standard will be effective for us on January 1, 2019. Early adoption is permitted. We are currently evaluating the timing of our adoption and the expected impact that this standard could have on our condensed consolidated financial statements and related disclosures. In March 2018, the FASB issued a new standard to incorporate SEC Staff Accounting Bulletin No. 118, or SAB 118, which addresses the accounting implications of the Tax Cuts and Jobs Act |
SUMMARY OF SIGNIFICANT ACCOUN15
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Accounting Policies [Abstract] | |
Common Shares Excluded from the Calculation of Net Loss Per Common Share | The following table sets forth for the periods presented the potential common shares (prior to consideration of the treasury stock method) excluded from the calculation of net loss per common share because their inclusion would be anti-dilutive, in thousands: At June 30, 2018 2017 Options to purchase common stock 12,794 12,372 Unvested restricted common stock 150 172 12,944 12,544 |
Cumulative Effect and Impact on Condensed Consolidated Balance Sheet and Consolidated Statement of Comprehensive Loss for Adoption of New Revenue Standard | The following table summarizes the cumulative effect to our condensed consolidated balance sheet upon the adoption of the new revenue standard on January 1, 2018, in thousands: Condensed Consolidated Balance Sheet Balance at December 31, 2017 Adjustments Balance at January 1, 2018 Deferred revenue, current portion $ 41,705 $ (34,463 ) $ 7,242 Deferred revenue, net of current portion $ 43,075 $ (33,747 ) $ 9,328 Accumulated deficit $ (2,147,685 ) $ 68,210 $ (2,079,475 ) In accordance with the new revenue standard requirements, the following tables summarize the impact of adoption on our condensed consolidated balance sheet and condensed consolidated statement of comprehensive loss, in thousands: At June 30, 2018 Condensed Consolidated Balance Sheet As Reported Balances Without Adoption of New Revenue Standard Effect of Change Higher/(Lower) Deferred revenue, current portion $ 9,161 $ 9,860 $ (699 ) Deferred revenue, net of current portion $ 4,522 $ 22,514 $ (17,992 ) Accumulated deficit $ (2,384,249 ) $ (2,403,024 ) $ (18,775 ) Three Months Ended June 30, 2018 Condensed Consolidated Statement of Comprehensive Loss As Reported Balances Without Adoption of New Revenue Standard Effect of Change Higher/(Lower) Net revenues from collaborators $ 29,907 $ 46,215 $ (16,308 ) Net loss $ (163,560 ) $ (147,252 ) $ 16,308 Net loss per common share - basic and diluted $ (1.63 ) $ (1.46 ) $ 0.17 Six Months Ended June 30, 2018 Condensed Consolidated Statement of Comprehensive Loss As Reported Balances Without Adoption of New Revenue Standard Effect of Change Higher/(Lower) Net revenues from collaborators $ 51,806 $ 101,241 $ (49,435 ) Net loss $ (304,774 ) $ (255,339 ) $ 49,435 Net loss per common share - basic and diluted $ (3.04 ) $ (2.55 ) $ 0.49 |
COLLABORATION AGREEMENTS (Table
COLLABORATION AGREEMENTS (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Revenue from Collaborators | The following table summarizes our total consolidated net revenues from collaborators, for the periods indicated, in thousands: Three Months Ended June 30, Six Months Ended June 30, Description 2018 2017 2018 2017 Sanofi Genzyme $ 23,077 $ 14,375 $ 41,930 $ 26,652 Vir Biotechnology 6,113 — 7,356 — MDCO 662 1,522 1,957 7,886 Other 55 35 563 354 Total net revenues from collaborators $ 29,907 $ 15,932 $ 51,806 $ 34,892 |
Balance and Change in Contract Liabilities | The following table presents the balance of our contract liabilities at June 30, 2018 and January 1, 2018, in thousands: At June 30, 2018 At January 1, 2018 Contract liabilities: Deferred revenues $ 13,683 $ 16,570 During the six months ended June 30, 2018, we recognized the following revenues as a result of the change in the contract liability balances, in thousands: Revenue recognized in the period from: Six Months Ended June 30, 2018 Amounts included in contract liability at the beginning of the period $ 11,996 |
Schedule of Research and Development Expenses Incurred by Type that are Directly Attributable to Each Agreement | The following table provides the research and development expenses incurred by type that are directly attributable to each agreement for the periods indicated, in thousands: Three Months Ended June 30, Six Months Ended June 30, 2018 2017 2018 2017 Sanofi Genzyme Vir MDCO Sanofi Genzyme Vir MDCO Sanofi Genzyme Vir MDCO Sanofi Genzyme Vir MDCO Research and development Clinical trial and manufacturing $ 17,572 $ 5,497 $ — $ 43,780 $ — $ — $ 28,095 $ 6,051 $ 641 $ 84,355 $ — $ 5,095 External services 1,834 6,151 — 929 — — 4,507 6,351 — 1,496 — — Other 241 292 — 1,554 — — 750 980 — 2,990 — 24 Total research and development expenses $ 19,647 $ 11,940 $ — $ 46,263 $ — $ — $ 33,352 $ 13,382 $ 641 $ 88,841 $ — $ 5,119 |
Prior Revenue Standard | ASU 2014-09 Revenue from Contracts with Customers | |
Revenue from Collaborators | The following table summarizes our total consolidated net revenues from collaborators, using the prior revenue standard, for the periods indicated, in thousands: Three Months Ended June 30, Six Months Ended June 30, Description 2018 2017 2018 2017 Sanofi Genzyme $ 36,539 $ 14,375 $ 86,969 $ 26,652 Vir Biotechnology 6,113 — 7,356 — MDCO 3,508 1,522 6,353 7,886 Other 55 35 563 354 Total net revenues from collaborators $ 46,215 $ 15,932 $ 101,241 $ 34,892 |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Assets Measured on a Recurring Basis | The following tables present information about our assets that are measured at fair value on a recurring basis at June 30, 2018 and December 31, 2017, and indicate the fair value hierarchy of the valuation techniques we utilized to determine such fair value, in thousands: Description At June 30, 2018 Quoted Prices in Active Markets (Level 1) Significant Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Cash equivalents: Certificates of deposit $ 5,000 $ — $ 5,000 $ — Commercial paper 3,700 — 3,700 — Corporate notes 2,000 — 2,000 — Money market funds 307,602 307,602 — — Marketable debt securities: Certificates of deposit 33,042 — 33,042 — Commercial paper 145,245 — 145,245 — Corporate notes 356,465 — 356,465 — U.S. government-sponsored enterprise securities 261,774 — 261,774 — U.S. treasury securities 277,639 — 277,639 — Marketable equity securities 12,044 12,044 — — Restricted cash (money market funds) 1,474 1,474 — — Total $ 1,405,985 $ 321,120 $ 1,084,865 $ — Description At December 31, 2017 Quoted Prices in Active Markets (Level 1) Significant Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Cash equivalents: Commercial paper $ 82,262 $ — $ 82,262 $ — Corporate notes 18,116 — 18,116 — U.S. government-sponsored enterprise securities 231,122 — 231,122 — U.S. treasury securities 62,855 — 62,855 — Money market funds 122,986 122,986 — — Marketable debt securities: Certificates of deposit 30,200 — 30,200 — Commercial paper 56,951 — 56,951 — Corporate notes 373,252 — 373,252 — U.S. government-sponsored enterprise securities 398,298 — 398,298 — U.S. treasury securities 200,475 — 200,475 — Restricted cash (money market funds) 1,471 1,471 — — Total $ 1,577,988 $ 124,457 $ 1,453,531 $ — |
MARKETABLE DEBT SECURITIES (Tab
MARKETABLE DEBT SECURITIES (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Investments In Marketable Debt Securities [Abstract] | |
Summary of Company's Marketable Debt Securities | The following tables summarize our marketable debt securities at June 30, 2018 and December 31, 2017, in thousands: At June 30, 2018 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Certificates of deposit $ 33,042 $ — $ — $ 33,042 Commercial paper 145,245 — — 145,245 Corporate notes 356,938 7 (480 ) 356,465 U.S. government-sponsored enterprise securities 262,109 — (335 ) 261,774 U.S. treasury securities 277,846 — (207 ) 277,639 Total $ 1,075,180 $ 7 $ (1,022 ) $ 1,074,165 At December 31, 2017 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Certificates of deposit $ 30,200 $ — $ — $ 30,200 Commercial paper 56,951 — — 56,951 Corporate notes 373,736 11 (495 ) 373,252 U.S. government-sponsored enterprise securities 399,281 — (983 ) 398,298 U.S. treasury securities 200,649 1 (175 ) 200,475 Total $ 1,060,817 $ 12 $ (1,653 ) $ 1,059,176 |
Summary of Available-For-Sale Debt Securities by Contractual Maturity | The following table summarizes our available-for-sale debt securities by contractual maturity, at June 30, 2018, in thousands: At June 30, 2018 Amortized Fair Value Less than one year $ 1,075,180 $ 1,074,165 Greater than one year but less than two years — — Total $ 1,075,180 $ 1,074,165 |
Disclosure - Potential Common S
Disclosure - Potential Common Shares Excluded from the Calculation of Net Loss Per Common Share (Detail) - shares shares in Thousands | 6 Months Ended | |
Jun. 30, 2018 | Jun. 30, 2017 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of earnings per share | 12,944 | 12,544 |
Options to purchase common stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of earnings per share | 12,794 | 12,372 |
Unvested restricted common stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of earnings per share | 150 | 172 |
Summary of Significant Accoun20
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) | Apr. 18, 2018 | Jan. 01, 2018 | May 31, 2017 | Mar. 31, 2014 | Feb. 28, 2014 | Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | Dec. 31, 2017 |
Significant Accounting Policies [Line Items] | ||||||||||
Issuance of common stock, net of offering costs (in shares) | 5,000,000 | |||||||||
Underwritten public offering amount per share | $ 71.87 | |||||||||
Issuance of common stock, net of offering costs | $ 355,200,000 | |||||||||
Underwriting discounts and commissions and other offering expenses | $ 4,200,000 | |||||||||
Stockholders' equity, decrease | $ 145,600,000 | |||||||||
Gains or losses from sale of available-for-sale debt securities | 0 | $ 0 | ||||||||
Reclassification from AOCI for Available for sale debt securities | $ 0 | 0 | ||||||||
Marketable securities classified as cash equivalents, maximum original maturity | 90 days | |||||||||
Policy for marketable securities | 90 days | |||||||||
Unrealized gain on equity securities | $ 2,044,000 | |||||||||
Litigation settlement, common stock issuable from other party | 983,208 | |||||||||
Realized loss on sale of marketable equity securities | $ 345,000 | 1,894,000 | ||||||||
Accumulated other comprehensive loss, net of tax | $ 33,807,000 | 33,807,000 | $ 34,433,000 | |||||||
Deferred revenue, current portion | 9,161,000 | 9,161,000 | 41,705,000 | |||||||
Deferred revenue, net of current portion | 4,522,000 | 4,522,000 | 43,075,000 | |||||||
Capitalized cost | 0 | 0 | ||||||||
Gain on litigation settlement | 20,564,000 | 20,564,000 | ||||||||
Recognition of deferred revenue | 11,996,000 | |||||||||
ASU 2014-09 Revenue from Contracts with Customers | ||||||||||
Significant Accounting Policies [Line Items] | ||||||||||
Deferred revenue, current portion | $ 7,242,000 | |||||||||
Deferred revenue, net of current portion | 9,328,000 | |||||||||
ASU 2014-09 Revenue from Contracts with Customers | Reduction In Deferred Revenue | ||||||||||
Significant Accounting Policies [Line Items] | ||||||||||
Offsetting adjustments to accumulated deficit | (68,200,000) | |||||||||
ASU 2014-09 Revenue from Contracts with Customers | Reduction In Deferred Tax Asset | ||||||||||
Significant Accounting Policies [Line Items] | ||||||||||
Offsetting adjustments to accumulated deficit | (13,600,000) | |||||||||
Regulus Therapeutics Inc | ||||||||||
Significant Accounting Policies [Line Items] | ||||||||||
Realized loss on sale of marketable equity securities | $ 300,000 | $ 1,900,000 | ||||||||
Accumulated other comprehensive loss, net of tax | 32,800,000 | 32,800,000 | $ 32,800,000 | |||||||
Dicerna Pharmaceuticals, Inc | ||||||||||
Significant Accounting Policies [Line Items] | ||||||||||
Unrealized gain on equity securities | 2,000,000 | $ 2,000,000 | ||||||||
Litigation settlement, common stock issuable from other party | 983,208 | |||||||||
Gain on litigation settlement | $ 20,600,000 | |||||||||
Valuation at settlement date of common stock received from litigation settlement | $ 10,000,000 | |||||||||
Upfront cash payment | 2,000,000 | |||||||||
Litigation settlement discounted present value of additional payment | 8,600,000 | |||||||||
Additional payment due from litigation settlement | $ 13,000,000 | |||||||||
Litigation settlement agreement payment due date for additional payment | Apr. 18, 2022 | |||||||||
Sanofi Genzyme | ||||||||||
Significant Accounting Policies [Line Items] | ||||||||||
Issuance of common stock, net of offering costs (in shares) | 344,448 | 8,766,338 | ||||||||
Underwritten public offering amount per share | $ 85.72 | |||||||||
Sanofi Genzyme | ASU 2014-09 Revenue from Contracts with Customers | ||||||||||
Significant Accounting Policies [Line Items] | ||||||||||
Recognition of deferred revenue | 45,700,000 | |||||||||
Remaining deferred revenues | 3,500,000 | |||||||||
Mdco | ASU 2014-09 Revenue from Contracts with Customers | ||||||||||
Significant Accounting Policies [Line Items] | ||||||||||
Recognition of deferred revenue | 4,500,000 | |||||||||
Remaining deferred revenues | 1,200,000 | |||||||||
Kyowa Hakko Kirin | ASU 2014-09 Revenue from Contracts with Customers | ||||||||||
Significant Accounting Policies [Line Items] | ||||||||||
Recognition of deferred revenue | $ 15,500,000 |
Cumulative Effect to Condensed
Cumulative Effect to Condensed Consolidated Balance Sheet for Adoption of New Revenue Standard (Detail) - USD ($) $ in Thousands | Jun. 30, 2018 | Jan. 01, 2018 | Dec. 31, 2017 |
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | |||
Deferred revenue, current portion | $ 9,161 | $ 41,705 | |
Deferred revenue, net of current portion | 4,522 | 43,075 | |
Accumulated deficit | (2,384,249) | $ (2,147,685) | |
ASU 2014-09 Revenue from Contracts with Customers | |||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | |||
Deferred revenue, current portion | $ 7,242 | ||
Deferred revenue, net of current portion | 9,328 | ||
Accumulated deficit | (2,079,475) | ||
ASU 2014-09 Revenue from Contracts with Customers | Effect of Change Higher/(Lower) | |||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | |||
Deferred revenue, current portion | (699) | (34,463) | |
Deferred revenue, net of current portion | (17,992) | (33,747) | |
Accumulated deficit | $ (18,775) | $ 68,210 |
Impact on Condensed Consolidate
Impact on Condensed Consolidated Balance Sheet and Consolidated Statement of Comprehensive Loss for Adoption of New Revenue Standard (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | Jan. 01, 2018 | Dec. 31, 2017 | |
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | ||||||
Deferred revenue, current portion | $ 9,161 | $ 9,161 | $ 41,705 | |||
Deferred revenue, net of current portion | 4,522 | 4,522 | 43,075 | |||
Accumulated deficit | (2,384,249) | (2,384,249) | $ (2,147,685) | |||
Net revenues from collaborators | 29,907 | $ 15,932 | 51,806 | $ 34,892 | ||
Net loss | $ (163,560) | $ (118,420) | $ (304,774) | $ (225,710) | ||
Net loss per common share - basic and diluted | $ (1.63) | $ (1.34) | $ (3.04) | $ (2.59) | ||
Collaboration Agreement | ||||||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | ||||||
Net revenues from collaborators | $ 29,907 | $ 15,932 | $ 51,806 | $ 34,892 | ||
ASU 2014-09 Revenue from Contracts with Customers | ||||||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | ||||||
Deferred revenue, current portion | $ 7,242 | |||||
Deferred revenue, net of current portion | 9,328 | |||||
Accumulated deficit | (2,079,475) | |||||
ASU 2014-09 Revenue from Contracts with Customers | Balances Without Adoption of New Revenue Standard | ||||||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | ||||||
Deferred revenue, current portion | 9,860 | 9,860 | ||||
Deferred revenue, net of current portion | 22,514 | 22,514 | ||||
Accumulated deficit | (2,403,024) | (2,403,024) | ||||
Net revenues from collaborators | 46,215 | 101,241 | ||||
Net loss | $ (147,252) | $ (255,339) | ||||
Net loss per common share - basic and diluted | $ (1.46) | $ (2.55) | ||||
ASU 2014-09 Revenue from Contracts with Customers | Balances Without Adoption of New Revenue Standard | Collaboration Agreement | ||||||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | ||||||
Net revenues from collaborators | $ 46,215 | $ 101,241 | ||||
ASU 2014-09 Revenue from Contracts with Customers | Effect of Change Higher/(Lower) | ||||||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | ||||||
Deferred revenue, current portion | (699) | (699) | (34,463) | |||
Deferred revenue, net of current portion | (17,992) | (17,992) | (33,747) | |||
Accumulated deficit | (18,775) | (18,775) | $ 68,210 | |||
Net loss | $ 16,308 | $ 49,435 | ||||
Net loss per common share - basic and diluted | $ 0.17 | $ 0.49 | ||||
ASU 2014-09 Revenue from Contracts with Customers | Effect of Change Higher/(Lower) | Collaboration Agreement | ||||||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | ||||||
Net revenues from collaborators | $ (16,308) | $ (49,435) |
Revenue from Collaborators (Det
Revenue from Collaborators (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Total net revenues from collaborators | $ 29,907 | $ 15,932 | $ 51,806 | $ 34,892 |
Prior Revenue Standard | ASU 2014-09 Revenue from Contracts with Customers | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Total net revenues from collaborators | 46,215 | 101,241 | ||
Sanofi Genzyme | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Total net revenues from collaborators | 23,077 | 14,375 | 41,930 | 26,652 |
Sanofi Genzyme | Prior Revenue Standard | ASU 2014-09 Revenue from Contracts with Customers | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Total net revenues from collaborators | 36,539 | 86,969 | ||
Vir Biotechnology | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Total net revenues from collaborators | 6,113 | 7,356 | ||
Vir Biotechnology | Prior Revenue Standard | ASU 2014-09 Revenue from Contracts with Customers | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Total net revenues from collaborators | 6,113 | 7,356 | ||
Mdco | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Total net revenues from collaborators | 662 | 1,522 | 1,957 | 7,886 |
Mdco | Prior Revenue Standard | ASU 2014-09 Revenue from Contracts with Customers | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Total net revenues from collaborators | 3,508 | 6,353 | ||
Other | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Total net revenues from collaborators | 55 | $ 35 | 563 | $ 354 |
Other | Prior Revenue Standard | ASU 2014-09 Revenue from Contracts with Customers | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Total net revenues from collaborators | $ 55 | $ 563 |
Balance of Contract Liabilities
Balance of Contract Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2018 | Jan. 01, 2018 |
Contract liabilities: | ||
Deferred revenues | $ 13,683 | $ 16,570 |
Change in Contract Liability Ba
Change in Contract Liability Balance (Detail) $ in Thousands | 6 Months Ended |
Jun. 30, 2018USD ($) | |
Revenue recognized in the period from: | |
Amounts included in contract liability at the beginning of the period | $ 11,996 |
Schedule of Research and Develo
Schedule of Research and Development Expenses Incurred by Type that are Directly Attributable to Each Agreement (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Total research and development expenses | [1] | $ 137,582 | $ 90,627 | $ 234,439 | $ 177,611 |
Sanofi Genzyme | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Total research and development expenses | 19,647 | 46,263 | 33,352 | 88,841 | |
Vir | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Total research and development expenses | 11,940 | 13,382 | |||
Mdco | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Total research and development expenses | 641 | 5,119 | |||
Clinical trial and manufacturing | Sanofi Genzyme | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Total research and development expenses | 17,572 | 43,780 | 28,095 | 84,355 | |
Clinical trial and manufacturing | Vir | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Total research and development expenses | 5,497 | 6,051 | |||
Clinical trial and manufacturing | Mdco | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Total research and development expenses | 641 | 5,095 | |||
External services | Sanofi Genzyme | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Total research and development expenses | 1,834 | 929 | 4,507 | 1,496 | |
External services | Vir | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Total research and development expenses | 6,151 | 6,351 | |||
Other | Sanofi Genzyme | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Total research and development expenses | 241 | $ 1,554 | 750 | 2,990 | |
Other | Vir | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Total research and development expenses | $ 292 | $ 980 | |||
Other | Mdco | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Total research and development expenses | $ 24 | ||||
[1] | Stock-based compensation expenses included in operating expenses are as follows: Research and development $11,616 $13,254 $21,753 $21,945 General and administrative 10,625 10,776 20,072 17,802 |
Collaboration Agreements - Addi
Collaboration Agreements - Additional Information (Detail) | Jan. 01, 2018USD ($) | Jan. 14, 2014USD ($) | Oct. 31, 2012USD ($) | Jan. 31, 2018USD ($)MilestonePayment | May 31, 2017USD ($)$ / sharesshares | Jan. 31, 2017USD ($) | Feb. 29, 2016USD ($)shares | Jan. 31, 2015USD ($)shares | Mar. 31, 2014USD ($)shares | Feb. 28, 2014USD ($)$ / sharesshares | Jun. 30, 2018USD ($) | Mar. 31, 2018USD ($) | Jun. 30, 2017USD ($) | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) | Jun. 30, 2018USD ($) | Jun. 30, 2017USD ($) | Dec. 31, 2014USD ($) | Dec. 31, 2017USD ($) |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Deferred revenue | $ 16,570,000 | $ 13,683,000 | $ 13,683,000 | ||||||||||||||||
Revenues recognized | 29,907,000 | $ 15,932,000 | 51,806,000 | $ 34,892,000 | |||||||||||||||
Issuance of common stock, net of offering costs (in shares) | shares | 5,000,000 | ||||||||||||||||||
Proceeds from issuance of common stock to Sanofi Genzyme | 21,381,000 | ||||||||||||||||||
Common stock price | $ / shares | $ 71.87 | ||||||||||||||||||
Prior Revenue Standard | ASU 2014-09 Revenue from Contracts with Customers | |||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Revenues recognized | 46,215,000 | 101,241,000 | |||||||||||||||||
2018 Restructured Agreement | |||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Deferred revenue | 2,900,000 | ||||||||||||||||||
Maximum funding for development and commercialization costs for fitusiran, during transition period | 50,000,000 | 50,000,000 | |||||||||||||||||
2018 Restructured Agreement | Fitusiran | |||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Revenues recognized | 23,100,000 | 39,100,000 | |||||||||||||||||
2018 Restructured Agreement | Fitusiran | Prior Revenue Standard | ASU 2014-09 Revenue from Contracts with Customers | |||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Deferred revenue | $ 23,400,000 | ||||||||||||||||||
Revenues recognized | 36,500,000 | 61,100,000 | |||||||||||||||||
Incremental to transaction price | 22,800,000 | ||||||||||||||||||
2018 Restructured Agreement | Fitusiran | Maximum | |||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Amount of costs expected to be incurred | 40,000,000 | ||||||||||||||||||
2018 Restructured Agreement | Fitusiran | Minimum | |||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Amount of costs expected to be incurred | 35,000,000 | ||||||||||||||||||
2018 Restructured Agreement Related to TTR Programs | Prior Revenue Standard | ASU 2014-09 Revenue from Contracts with Customers | |||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Deferred revenue | 25,800,000 | ||||||||||||||||||
Sanofi Genzyme | |||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Upfront fee received | $ 22,500,000 | ||||||||||||||||||
Amount earned upon achievement of milestone | $ 11,000,000 | ||||||||||||||||||
Unearned milestones included in transaction price | 0 | ||||||||||||||||||
Revenues recognized | $ 23,077,000 | $ 14,375,000 | $ 41,930,000 | $ 26,652,000 | |||||||||||||||
Issuance of common stock, net of offering costs (in shares) | shares | 344,448 | 8,766,338 | |||||||||||||||||
Proceeds from issuance of common stock to Sanofi Genzyme | $ 23,000,000 | $ 700,000,000 | |||||||||||||||||
Common stock price | $ / shares | $ 85.72 | ||||||||||||||||||
Fair value of shares issued | $ 751,500,000 | ||||||||||||||||||
Excess of fair value over cash received for stock issuance | 51,500,000 | ||||||||||||||||||
Provision for (Benefit from) income taxes | $ (15,200,000) | ||||||||||||||||||
Percentage ownership interest owned by noncontrolling owners | 11.00% | 11.00% | |||||||||||||||||
Sanofi Genzyme | Concurrent Private Placement | |||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Issuance of common stock, net of offering costs (in shares) | shares | 297,501 | 744,566 | |||||||||||||||||
Proceeds from issuance of common stock to Sanofi Genzyme | $ 21,400,000 | $ 70,700,000 | |||||||||||||||||
Sanofi Genzyme | Compensatory Purposes | |||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Issuance of common stock, net of offering costs (in shares) | shares | 205,030 | 196,251 | |||||||||||||||||
Proceeds from issuance of common stock to Sanofi Genzyme | $ 14,300,000 | $ 18,300,000 | |||||||||||||||||
Sanofi Genzyme | ASU 2014-09 Revenue from Contracts with Customers | |||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Transaction price | 3,500,000 | ||||||||||||||||||
Sanofi Genzyme | Prior Revenue Standard | ASU 2014-09 Revenue from Contracts with Customers | |||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Revenues recognized | $ 36,539,000 | $ 86,969,000 | |||||||||||||||||
Sanofi Genzyme | Revusiran | |||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Amount earned upon achievement of milestone | $ 25,000,000 | ||||||||||||||||||
Sanofi Genzyme | Fitusiran | |||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Cost-share reimbursements, net of payments including transaction price | 147,300,000 | ||||||||||||||||||
Sanofi Genzyme | Product Alliances | |||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Upfront fee received | $ 22,500,000 | ||||||||||||||||||
Amount earned upon achievement of milestone | 11,000,000 | ||||||||||||||||||
Deferred revenue | $ 33,500,000 | ||||||||||||||||||
Sanofi Genzyme | Regional Collaboration Product | |||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Percentage of sharing in development cost | 20.00% | ||||||||||||||||||
Maximum number of potential future milestones | $ 75,000,000 | ||||||||||||||||||
Potential future payment for the achievement of certain development milestones | 55,000,000 | ||||||||||||||||||
Potential future payment for the achievement of specified commercialization milestones | $ 20,000,000 | ||||||||||||||||||
Royalty rate | 20.00% | ||||||||||||||||||
Sanofi Genzyme | Co-developed/ Co-commercialized Collaboration Product | |||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Percentage of sharing in development cost | 50.00% | ||||||||||||||||||
Royalty rate | 20.00% | ||||||||||||||||||
Received incremental share of co-development costs for exercise of right, fitusiran | $ 6,000,000 | ||||||||||||||||||
Expected first milestone payment to be received fitusiran | $ 25,000,000 | ||||||||||||||||||
Sanofi Genzyme | Co-developed/ Co-commercialized Collaboration Product | Revusiran | |||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Amount earned upon achievement of milestone | $ 25,000,000 | ||||||||||||||||||
Sanofi Genzyme | Global Collaboration Product | |||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Percentage of sharing in development cost | 100.00% | ||||||||||||||||||
Maximum number of potential future milestones | $ 200,000,000 | ||||||||||||||||||
Potential future payment for the achievement of certain development milestones | 100,000,000 | ||||||||||||||||||
Potential future payment for the achievement of specified commercialization milestones | 100,000,000 | ||||||||||||||||||
Royalty rate | 20.00% | ||||||||||||||||||
Sanofi Genzyme | AT3 License Terms and the Exclusive TTR License | |||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Maximum funding for development and commercialization costs for fitusiran, during transition period | $ 50,000,000 | ||||||||||||||||||
Sanofi Genzyme | TTR License | |||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Transaction price | 127,600,000 | ||||||||||||||||||
Sanofi Genzyme | TTR License | Revusiran | |||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Cost-share reimbursements, net of payments including transaction price | 57,000,000 | ||||||||||||||||||
Sanofi Genzyme | TTR License | Patisiran | |||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Cost-share reimbursements, net of payments including transaction price | $ 63,600,000 | ||||||||||||||||||
Sanofi Genzyme | TTR License | Patisiran | Japan | |||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Royalty rate | 25.00% | ||||||||||||||||||
Sanofi Genzyme | TTR License | Patisiran | Maximum | Excluding United States, Canada and Western Europe | |||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Royalty rate | 25.00% | ||||||||||||||||||
Sanofi Genzyme | TTR License | TTRsc02 | Maximum | |||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Royalty rate | 30.00% | ||||||||||||||||||
Sanofi Genzyme | TTR License | TTRsc02 | Minimum | |||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Royalty rate | 15.00% | ||||||||||||||||||
Sanofi Genzyme | TTR License | Back-up Products | Maximum | |||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Royalty rate | 15.00% | ||||||||||||||||||
Sanofi Genzyme | AT3 License Terms | |||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Royalty rate | 15.00% | ||||||||||||||||||
Number of milestone payments required | MilestonePayment | 1 | ||||||||||||||||||
Expected milestone payment to be received fitusiran | $ 50,000,000 | ||||||||||||||||||
Sanofi Genzyme | AT3 License Terms | Maximum | |||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Royalty rate | 30.00% | ||||||||||||||||||
Sanofi Genzyme | AT3 License Terms | Minimum | |||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Royalty rate | 15.00% | ||||||||||||||||||
Sanofi Genzyme | 2018 Restructured Agreement | Fitusiran | |||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Amount earned upon achievement of milestone | $ 50,000,000 | ||||||||||||||||||
Deferred revenue | $ 600,000 | ||||||||||||||||||
Transaction price | $ 40,800,000 |
Fair Value of Assets Measured o
Fair Value of Assets Measured on a Recurring Basis (Detail) - USD ($) $ in Thousands | Jun. 30, 2018 | Dec. 31, 2017 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available for sale debt securities, Fair value disclosure | $ 1,074,165 | $ 1,059,176 |
Marketable equity securities | 12,044 | |
Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable equity securities | 12,044 | |
Total | 1,405,985 | 1,577,988 |
Recurring | Quoted Prices in Active Markets (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable equity securities | 12,044 | |
Total | 321,120 | 124,457 |
Recurring | Significant Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total | 1,084,865 | 1,453,531 |
Recurring | Certificate of deposit | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 5,000 | |
Available for sale debt securities, Fair value disclosure | 33,042 | 30,200 |
Recurring | Certificate of deposit | Significant Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 5,000 | |
Available for sale debt securities, Fair value disclosure | 33,042 | 30,200 |
Recurring | Money Market Funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 307,602 | 122,986 |
Restricted cash | 1,474 | 1,471 |
Recurring | Money Market Funds | Quoted Prices in Active Markets (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 307,602 | 122,986 |
Restricted cash | 1,474 | 1,471 |
Recurring | Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 3,700 | 82,262 |
Available for sale debt securities, Fair value disclosure | 145,245 | 56,951 |
Recurring | Commercial paper | Significant Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 3,700 | 82,262 |
Available for sale debt securities, Fair value disclosure | 145,245 | 56,951 |
Recurring | Corporate notes | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 2,000 | 18,116 |
Available for sale debt securities, Fair value disclosure | 356,465 | 373,252 |
Recurring | Corporate notes | Significant Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 2,000 | 18,116 |
Available for sale debt securities, Fair value disclosure | 356,465 | 373,252 |
Recurring | U.S. government-sponsored enterprise securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 231,122 | |
Available for sale debt securities, Fair value disclosure | 261,774 | 398,298 |
Recurring | U.S. government-sponsored enterprise securities | Significant Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 231,122 | |
Available for sale debt securities, Fair value disclosure | 261,774 | 398,298 |
Recurring | U.S. treasury securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 62,855 | |
Available for sale debt securities, Fair value disclosure | 277,639 | 200,475 |
Recurring | U.S. treasury securities | Significant Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 62,855 | |
Available for sale debt securities, Fair value disclosure | $ 277,639 | $ 200,475 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) $ in Millions | Apr. 18, 2018USD ($) | Jun. 30, 2018USD ($) |
Significant Unobservable Inputs (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value of long-term debt | $ 30.1 | |
Dicerna Pharmaceuticals, Inc | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Additional payment due from litigation settlement | $ 13 | |
Litigation settlement agreement payment due date for additional payment | Apr. 18, 2022 | |
Dicerna Pharmaceuticals, Inc | Measurement Input, Present Value Discount Interest Rate | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Interest rate | 0.11 | |
Dicerna Pharmaceuticals, Inc | Level 2 | Long-term Other Assets | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value of long-term other assets | $ 8.7 |
Summary of Company's Marketable
Summary of Company's Marketable Debt Securities (Detail) - USD ($) $ in Thousands | Jun. 30, 2018 | Dec. 31, 2017 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 1,075,180 | $ 1,060,817 |
Gross Unrealized Gains | 7 | 12 |
Gross Unrealized Losses | (1,022) | (1,653) |
Fair Value | 1,074,165 | 1,059,176 |
Certificate of deposit | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 33,042 | 30,200 |
Fair Value | 33,042 | 30,200 |
Commercial paper | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 145,245 | 56,951 |
Fair Value | 145,245 | 56,951 |
Corporate notes | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 356,938 | 373,736 |
Gross Unrealized Gains | 7 | 11 |
Gross Unrealized Losses | (480) | (495) |
Fair Value | 356,465 | 373,252 |
U.S. government-sponsored enterprise securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 262,109 | 399,281 |
Gross Unrealized Losses | (335) | (983) |
Fair Value | 261,774 | 398,298 |
U.S. treasury securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 277,846 | 200,649 |
Gross Unrealized Gains | 1 | |
Gross Unrealized Losses | (207) | (175) |
Fair Value | $ 277,639 | $ 200,475 |
Summary of Available-For-Sale D
Summary of Available-For-Sale Debt Securities by Contractual Maturity (Detail) - USD ($) $ in Thousands | Jun. 30, 2018 | Dec. 31, 2017 |
Amortized Cost | ||
Less than one year | $ 1,075,180 | |
Amortized Cost | 1,075,180 | $ 1,060,817 |
Fair Value | ||
Less than one year | 1,074,165 | |
Total | $ 1,074,165 | $ 1,059,176 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) | Apr. 18, 2018USD ($)shares | Apr. 29, 2016USD ($) | Dec. 31, 2017USD ($) | Jun. 30, 2018USD ($) | Apr. 30, 2016a |
Commitments And Contingencies [Line Items] | |||||
Property, plant and equipment, net | $ 181,900,000 | $ 227,839,000 | |||
Restricted investments | 30,000,000 | 44,825,000 | |||
Litigation settlement, common stock issuable from other party | shares | 983,208 | ||||
Dicerna Pharmaceuticals, Inc | |||||
Commitments And Contingencies [Line Items] | |||||
Litigation settlement, settlement agreement date | April 18, 2018 | ||||
Litigation settlement amount | $ 25,000,000 | ||||
Upfront cash payment | $ 2,000,000 | ||||
Litigation settlement, common stock issuable from other party | shares | 983,208 | ||||
Litigation settlement, common stock value | $ 10,000,000 | ||||
Additional payment due from litigation settlement | $ 13,000,000 | ||||
Litigation settlement payment period | 4 years | ||||
Litigation settlement agreement payment due date for additional payment | Apr. 18, 2022 | ||||
Dicerna Pharmaceuticals, Inc | Minimum | Oligonucleotide | |||||
Commitments And Contingencies [Line Items] | |||||
Restriction period in development and other activities defined set of targets | 18 months | ||||
Dicerna Pharmaceuticals, Inc | Maximum | Oligonucleotide | |||||
Commitments And Contingencies [Line Items] | |||||
Restriction period in development and other activities defined set of targets | 4 years | ||||
Bank of America N.A | |||||
Commitments And Contingencies [Line Items] | |||||
Cash collateral required for principal amount outstanding, percentage | 100.00% | ||||
Bank of America N.A | Term Loan Facility | |||||
Commitments And Contingencies [Line Items] | |||||
Line of credit facility, maximum borrowing capacity | $ 120,000,000 | ||||
Repayment of outstanding principal amount in full | 120,000,000 | ||||
Line of credit facility, expiration date | Apr. 29, 2021 | ||||
Bank of America N.A | Term Loan Facility | LIBOR | |||||
Commitments And Contingencies [Line Items] | |||||
Debt instrument, basis spread on variable rate | 0.45% | ||||
Wells Fargo Bank, National Association | |||||
Commitments And Contingencies [Line Items] | |||||
Cash collateral required for principal amount outstanding, percentage | 100.00% | ||||
Restricted investments | 30,000,000 | 30,000,000 | |||
Wells Fargo Bank, National Association | Term Loan Facility | |||||
Commitments And Contingencies [Line Items] | |||||
Line of credit facility, maximum borrowing capacity | $ 30,000,000 | ||||
Line of credit facility, expiration date | Apr. 29, 2021 | ||||
Wells Fargo Bank, National Association | Term Loan Facility | LIBOR | |||||
Commitments And Contingencies [Line Items] | |||||
Debt instrument, basis spread on variable rate | 0.45% | ||||
Norton, Massachusetts | |||||
Commitments And Contingencies [Line Items] | |||||
Undeveloped land acquired | a | 12 | ||||
Norton, Massachusetts | Land and costs related to the construction of manufacturing facility | |||||
Commitments And Contingencies [Line Items] | |||||
Property, plant and equipment, net | $ 140,500,000 | $ 177,800,000 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended |
Jun. 30, 2018 | Jun. 30, 2018 | |
Income Tax Disclosure [Abstract] | ||
Provision for income taxes | $ 79,000 | $ 17,000 |
Tax cuts and jobs act of benefit for refundable credits | $ 800,000 |