ALNYLAM PHARMACEUTICALS, INC. 10-Q

ITEM 1. FINANCIAL STATEMENTS (Unaudited) CONDENSED CONSOLIDATED BALANCE SHEETS AS OF JUNE 3 0 , 2020 AND DECEMBER 31, 201 9 5 CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS FOR THE THREE AND SIX MONTHS ENDED JUNE 3 0 , 2020 AND 2019 6 CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY FOR THE THREE AND SIX MONTHS ENDED JUNE 3 0 , 2020 AND 2019 7 CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE SIX MONTHS ENDED JUNE 3 0 , 2020 AND 2019 9 NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS 10 ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 27 ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 36 ITEM 4. CONTROLS AND PROCEDURES 36 PART II. OTHER INFORMATION ITEM 1. LEGAL PROCEEDINGS 38 ITEM 1A. RISK FACTORS 38 ITEM 6. EXHIBITS 72 SIGNATURES 73 “Alnylam,” ONPATTRO ® , GIVLAARI ® , Alnylam Act ® and Alnylam Assist ® are registered trademarks of Alnylam Pharmaceuticals, Inc. Our logo, trademarks and service marks are property of Alnylam. All other trademarks or service marks appearing in this Quarterly Report on Form 10-Q are the property of their respective holders. 2 CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of the federal securities laws, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and are including this statement for purposes of complying with those safe harbor provisions. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “could,” “expects,” “plans,” “intends,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about: • risks related to the direct or indirect impact of the COVID-19 global pandemic or any future pandemic, such as the scope and duration of the pandemic, government actions and restrictive measures implemented in response, material delays in diagnoses of rare diseases, initiation or continuation of treatment for diseases addressed by our products, or in patient enrollment in clinical trials, potential clinical trial, regulatory review and inspection or supply chain disruptions, and other potential impacts to our business, the effectiveness or timeliness of steps taken by us to mitigate the impact of the pandemic, and our ability to execute business continuity plans to address disruptions caused by the COVID-19 or any future pandemic; • our views with respect to the potential for RNAi therapeutics, including ONPATTRO, GIVLAARI, lumasiran, patisiran, inclisiran, vutrisiran and fitusiran; • our plans for additional global regulatory filings and the continuing product launches of ONPATTRO and GIVLAARI; • our expectations regarding the advancement of lumasiran and inclisiran through regulatory review and toward the market; • the progress of our research and development programs; • our current and anticipated clinical trials and expectations regarding the reporting of data from these trials; • our expectations regarding potential market size for, and the successful commercialization of, ONPATTRO, GIVLAARI or any future products, including lumasiran and inclisiran; • the timing of regulatory filings and interactions with or actions or advice of regulatory authorities, which may affect the design, initiation, timing, continuation and/or progress of clinical trials or result in the need for additional pre-clinical and/or clinical testing or the timing or likelihood of regulatory approvals; • our ability or, with respect to inclisiran, our partner’s ability, to obtain and maintain regulatory approval, pricing and reimbursement for O NPATTRO, GIVLAARI or any future products, including lumasiran and inclisiran ; • the status of our manufacturing operations and the construction of our manufacturing facility and any delays, interruptions or failures in the manufacture and supply of ONPATTRO, GIVLAARI, lumasiran, inclisiran, or any of our other product candidates by our contract manufacturers or by us; • our progress continuing to build and leverage global commercial infrastructure; • successfully launching, marketing and selling our approved products globally; • our ability to successfully expand the indication for ONPATTRO in the future; • the possible impact of any competing products on the commercial success of ONPATTRO and GIVLAARI and our product candidates, including lumasiran and inclisiran, and, with respect to inclisiran, our partner's ability to compete against such products; • our ability to manage our growth and operating expenses; • our expectations regarding our STAr pipeline growth strategy and our ability to meet or exceed our Alnylam 2020 guidance for the advancement and commercialization of RNAi therapeutics; • our expectations regarding the length of time our current cash, cash equivalents and marketable debt and equity securities will support our operations based on our current operating plan; • our belief that the funding provided by our strategic financing collaboration with The Blackstone Group Inc. and certain of its affiliates should enable us to achieve a self-sustainable profile without the need for future equity financing; • our dependence on third parties for development, manufacture and distribution of products; 3 • our expectations regarding our corporate collaborations, including potential future licensing fees and milestone and royalty payments under existing or future agreements; • obtaining, maintaining and protecting our intellectual property; • our ability to attract and retain qualified key management and scientists, development, medical and commercial staff, consultants and advisors; • the outcome of litigation or other legal proceedings; • the risk of government investigations; • regulatory developments in the United States, or U.S., and foreign countries; • the impact of laws and regulations; • developments relating to our competitors and our industry; and • other risks and uncertainties, including those listed under the caption Part II, Item 1A, "Risk Factors" of this Quarterly Report on Form 10-Q. The risks set forth above are not exhaustive. Other sections of this Quarterly Report may include additional factors that could adversely affect our business and financial performance. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time and it is not possible for management to predict all risk factors, nor can we assess the impact of all risk factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Any forward-looking statements in this Quarterly Report on Form 10-Q reflect our current views with respect to future events and with respect to our business and future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those described under Part II, Item 1A, "Risk Factors" and elsewhere in this Quarterly Report on Form 10-Q. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future. You are advised, however, to consult any further disclosure we make in our reports filed with the SEC. This Quarterly Report on Form 10-Q may include data that we obtained from industry publications and third-party research, surveys and studies. Industry publications and third-party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. This Quarterly Report on Form 10-Q also may include data based on our own internal estimates and research, including estimates regarding the impact of the COVID-19 pandemic on our financial statements and business operations. Our internal estimates have not been verified by any independent source and, while we believe any data obtained from industry publications and third-party research, surveys and studies are reliable, we have not independently verified such data. Such third-party data, as well as our internal estimates and research, are subject to a high degree of uncertainty and risk due to a variety of factors, including those described in Part II, Item 1A, "Risk Factors" and elsewhere in this Quarterly Report on Form 10-Q. These and other factors could cause our results to differ materially from those expressed in this Quarterly Report on Form 10-Q. 4 Table of Contents ALNYLAM PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except per share amounts) (Unaudited) June 30, 2020 December 31, 2019 ASSETS Current assets: Cash and cash equivalents $ 580,829 $ 547,178 Marketable debt securities 1,258,425 975,017 Marketable equity securities 86,310 13,967 Accounts receivable, net 69,115 43,011 Inventory 77,418 56,348 Prepaid expenses and other current assets 88,349 80,343 Total current assets 2,160,446 1,715,864 Property, plant and equipment, net 439,126 425,179 Operating lease right-of-use assets 229,674 221,197 Restricted investments 24,725 14,825 Receivable related to the sale of future royalties 500,000 — Other assets 20,396 18,069 Total assets $ 3,374,367 $ 2,395,134 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $ 26,125 $ 49,884 Accrued expenses 211,186 197,201 Operating lease liability 33,447 27,688 Deferred revenue 107,587 77,821 Liability related to the sale of future royalties 5,957 — Total current liabilities 384,302 352,594 Operating lease liability, net of current portion 281,618 276,135 Deferred revenue, net of current portion 281,530 318,383 Liability related to the sale of future royalties, net of current portion 1,008,336 — Other liabilities 18,855 9,330 Total liabilities 1,974,641 956,442 Commitments and contingencies (Note 13) Stockholders’ equity: Preferred stock, $ 0.01 par value per share, 5,000 shares authorized and no shares issued and outstanding as of June 30, 2020 and December 31, 2019 — — Common stock, $ 0.01 par value per share, 250,000 shares authorized; 115,647 shares issued and outstanding as of June 30, 2020; 112,188 shares issued and outstanding as of December 31, 2019 1,156 1,122 Additional paid-in capital 5,520,320 5,201,176 Accumulated other comprehensive loss ( 33,212 ) ( 36,518 ) Accumulated deficit ( 4,088,538 ) ( 3,727,088 ) Total stockholders’ equity 1,399,726 1,438,692 Total liabilities and stockholders’ equity $ 3,374,367 $ 2,395,134 The accompanying notes are an integral part of these condensed consolidated financial statements. 5 Table of Contents ALNYLAM PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (In thousands, except per share amounts) (Unaudited) Three Months Ended June 30, Six Months Ended June 30, 2020 2019 2020 2019 Statements of Operations Revenues: Net product revenues $ 77,533 $ 38,231 $ 149,471 $ 64,522 Net revenues from collaborations 26,429 6,483 53,967 13,486 Total revenues 103,962 44,714 203,438 78,008 Operating costs and expenses: Cost of goods sold 19,929 4,326 33,231 7,673 Research and development 154,996 163,890 324,567 293,017 Selling, general and administrative 127,896 112,769 254,657 202,377 Total operating costs and expenses 302,821 280,985 612,455 503,067 Loss from operations ( 198,859 ) ( 236,271 ) ( 409,017 ) ( 425,059 ) Other income: Interest expense ( 27,248 ) — ( 27,248 ) — Interest income 3,165 8,781 8,645 16,306 Other income (expense) 45,039 ( 453 ) 68,071 ( 410 ) Change in fair value of liability obligation — 9,422 — 9,422 Total other income 20,956 17,750 49,468 25,318 Loss before income taxes ( 177,903 ) ( 218,521 ) ( 359,549 ) ( 399,741 ) Provision for income taxes ( 1,326 ) ( 960 ) ( 1,901 ) ( 1,655 ) Net loss $ ( 179,229 ) $ ( 219,481 ) $ ( 361,450 ) $ ( 401,396 ) Net loss per common share - basic and diluted $ ( 1.56 ) $ ( 2.02 ) $ ( 3.18 ) $ ( 3.75 ) Weighted-average common shares used to compute basic and diluted net loss per common share 114,911 108,576 113,830 106,997 Statements of Comprehensive Loss Net loss $ ( 179,229 ) $ ( 219,481 ) $ ( 361,450 ) $ ( 401,396 ) Other comprehensive (loss) income: Unrealized (loss) gain on marketable debt securities ( 1,796 ) 462 2,249 822 Foreign currency translation 571 842 911 842 Defined benefit pension plans, net of tax 72 ( 4,282 ) 146 ( 4,282 ) Total other comprehensive (loss) income ( 1,153 ) ( 2,978 ) 3,306 ( 2,618 ) Comprehensive loss $ ( 180,382 ) $ ( 222,459 ) $ ( 358,144 ) $ ( 404,014 ) The accompanying notes are an integral part of these condensed consolidated financial statements. 6 Table of Contents ALNYLAM PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (In thousands) (Unaudited) Common Stock Additional Paid-in Capital Accumulated Other Comprehensive Loss Accumulated Deficit Total Stockholders’ Equity Shares Amount Balance as of December 31, 2019 112,188 $ 1,122 $ 5,201,176 $ ( 36,518 ) $ ( 3,727,088 ) $ 1,438,692 Exercise of common stock options, net of tax withholdings 976 9 54,212 — — 54,221 Issuance of common stock under equity plans 4 — — — — — Stock-based compensation expense related to equity-classified awards — — 34,578 — — 34,578 Other comprehensive income — — — 4,459 — 4,459 Net loss — — — — ( 182,221 ) ( 182,221 ) Balance as of March 31, 2020 113,168 1,131 5,289,966 ( 32,059 ) ( 3,909,309 ) 1,349,729 Exercise of common stock options, net of tax withholdings 1,233 12 91,861 — — 91,873 Issuance of common stock under equity plans 283 3 5,298 — — 5,301 Issuance of common stock to strategic partners, net of closing costs 963 10 99,488 — — 99,498 Stock-based compensation expense related to equity-classified awards — — 33,707 — — 33,707 Other comprehensive loss — — — ( 1,153 ) — ( 1,153 ) Net loss — — — — ( 179,229 ) ( 179,229 ) Balance as of June 30, 2020 115,647 $ 1,156 $ 5,520,320 $ ( 33,212 ) $ ( 4,088,538 ) $ 1,399,726 The accompanying notes are an integral part of these condensed consolidated financial statements. 7 Table of Contents ALNYLAM PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (In thousands) (Unaudited) Common Stock Additional Paid-in Capital Accumulated Other Comprehensive Loss Accumulated Deficit Total Stockholders’ Equity Shares Amount Balance as of December 31, 2018 101,177 $ 1,011 $ 4,175,139 $ ( 33,213 ) $ ( 2,840,972 ) $ 1,301,965 Exercise of common stock options, net of tax withholdings 207 3 11,406 — — 11,409 Issuance of common stock under equity plans 4 — ( 58 ) — — ( 58 ) Issuance of common stock under benefit plans 12 — 784 — — 784 Issuance of common stock, net of costs 5,000 50 381,850 — — 381,900 Stock-based compensation expense related to equity-classified awards — — 32,541 — — 32,541 Other comprehensive income, net of tax — — — 360 — 360 Net loss — — — — ( 181,915 ) ( 181,915 ) Balance as of March 31, 2019 106,400 1,064 4,601,662 ( 32,853 ) ( 3,022,887 ) 1,546,986 Exercise of common stock options, net of tax withholdings 203 2 6,180 — — 6,182 Issuance of common stock under equity plans 55 — 4,022 — — 4,022 Issuance of common stock under benefit plans 12 — 1,089 — — 1,089 Issuance of common stock to strategic partners, net of closing costs 4,444 44 390,533 — — 390,577 Stock-based compensation expense related to equity-classified awards — — 30,798 — — 30,798 Other comprehensive loss, net of tax — — — ( 2,978 ) — ( 2,978 ) Net loss — — — — ( 219,481 ) ( 219,481 ) Balance as of June 30, 2019 111,114 $ 1,110 $ 5,034,284 $ ( 35,831 ) $ ( 3,242,368 ) $ 1,757,195 The accompanying notes are an integral part of these condensed consolidated financial statements. 8 Table of Contents ALNYLAM PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (In thousands) (Unaudited) Six Months Ended June 30, 2020 2019 Cash flows from operating activities: Net loss $ ( 361,450 ) $ ( 401,396 ) Non-cash adjustments to reconcile net loss to net cash (used in) provided by operating activities: Depreciation and amortization 15,813 7,694 Amortization and interest accretion related to operating leases 18,971 18,584 Non-cash imputed interest expense on liability related to the sale of future royalties 27,248 — Stock-based compensation 68,333 62,635 Unrealized gain on marketable equity securities ( 69,643 ) — Change in fair value of liability obligation — ( 9,422 ) Other 4,372 ( 1,924 ) Changes in operating assets and liabilities: Accounts receivable, net ( 26,099 ) ( 11,934 ) Proceeds from landlord lease incentive for tenant improvements 1,991 18,700 Inventory ( 24,178 ) ( 15,040 ) Prepaid expenses and other assets ( 13,560 ) 5,319 Accounts payable, accrued expenses and other liabilities 2,036 43,559 Deferred revenue ( 7,090 ) 399,173 Operating lease liability ( 18,235 ) ( 15,763 ) Net cash (used in) provided by operating activities ( 381,491 ) 100,185 Cash flows from investing activities: Purchases of property, plant and equipment ( 36,275 ) ( 65,293 ) Purchases of marketable debt securities ( 1,140,421 ) ( 834,563 ) Sales and maturities of marketable securities 859,354 713,106 Purchases of restricted investments ( 9,900 ) — Other investing activities ( 300 ) — Net cash used in investing activities ( 327,542 ) ( 186,750 ) Cash flows from financing activities: Proceeds from exercise of stock options and other types of equity, net 151,512 21,641 Proceeds from the sale of future royalties 500,000 — Proceeds from issuance of common stock to strategic partners, net of closing costs 99,498 400,000 Proceeds from public offering, net of costs — 381,900 Payment of transaction costs related to sale of future royalties and term loan facility ( 8,128 ) — Net cash provided by financing activities 742,882 803,541 Effect of exchange rate changes on cash, cash equivalents and restricted cash ( 196 ) ( 3 ) Net increase in cash, cash equivalents and restricted cash 33,653 716,973 Cash, cash equivalents and restricted cash, beginning of period 549,628 422,631 Cash, cash equivalents and restricted cash, end of period $ 583,281 $ 1,139,604 Supplemental disclosure of noncash investing and financing activities: Capital expenditures included in accounts payable and accrued expenses $ 6,402 $ 25,893 Lease liabilities arising from obtaining right-of-use assets $ 15,077 $ 1,728 Receivable and liability related to the sale of future royalties $ 500,000 $ — The accompanying notes are an integral part of these condensed consolidated financial statements. 9 Table of Contents ALNYLAM PHARMACEUTICALS, INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) 1. NATURE OF BUSINESS Alnylam Pharmaceuticals, Inc. (also referred to as Alnylam, we, our or us) commenced operations on June 14, 2002 as a biopharmaceutical company seeking to develop and commercialize novel therapeutics based on RNA interference, or RNAi. We are committed to the advancement of our company strategy of building a multi-product, global, commercial biopharmaceutical company with a deep and sustainable clinical pipeline of RNAi therapeutics for future growth and a robust, organic research engine for sustainable innovation and great potential for patient impact. Since inception, we have focused on discovering, developing and commercializing RNAi therapeutics by establishing and maintaining a strong intellectual property position in the RNAi field, establishing strategic alliances with leading pharmaceutical and life sciences companies, generating revenues through licensing agreements, and ultimately developing and commercializing RNAi therapeutics globally, either independently or with our strategic partners. We have devoted substantially all of our efforts to business planning, research, development, manufacturing and early commercial efforts, acquiring, filing and expanding intellectual property rights, recruiting management and technical staff, and raising capital. In August 2018, we received approval for ONPATTRO from the United States Food and Drug Administration, or FDA, and began commercializing and generating product revenues in the U.S., and also received marketing authorization for ONPATTRO from the European Commission, or EC. As of June 30, 2020, we have launched ONPATTRO in the U.S., Europe, Japan and in several additional countries. In November 2019, we received approval for GIVLAARI from the FDA and began commercializing and generating product revenues in the U.S. in December 2019. In March 2020, we received marketing authorization for GIVLAARI from the EC, and as of June 30, 2020, we have launched GIVLAARI in several countries in Europe. Regulatory filings in additional markets are pending or planned for 2020 and beyond for both products. In April 2020, we entered into a broad strategic financing collaboration with The Blackstone Group Inc. and certain of its affiliates which includes a purchase and sale agreement, a credit agreement, a stock purchase agreement, and potential funding for certain research and development activities, subject to completion of a definitive agreement, under which The Blackstone Group Inc., and certain of its affiliates, will provide up to $ 2.00 billion to support our advancement of innovative RNAi therapeutics. Each executed agreement is a separate unit of account and was recorded at fair value. Please read Note 5, Note 9 and Note 10, respectively, for additional information regarding each executed agreement set forth above. 2. BASIS OF PRESENTATION AND PRINCIPLES OF CONSOLIDATION The accompanying condensed consolidated financial statements of Alnylam 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, 2019, which were included in our Annual Report on Form 10-K that was filed with the Securities and Exchange Commission on February 13, 2020. 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. Our significant accounting policies are described in Note 2 of the Notes to Consolidated Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2019. Updates to our significant accounting policies, including the liability related to the sale of future royalties accounting policy, resulting from the execution of a purchase and sale agreement with certain affiliates of The Blackstone Group Inc., are discussed below. Reclassification Certain prior period amounts in the condensed consolidated financial statements have been reclassified to conform to the current period presentation. Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America, or 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. The full extent to which the COVID-19 pandemic will directly or indirectly impact our business, results of operations and financial condition, including sales, expenses, reserves and allowances, the supply of our products and product candidates, clinical trials and research and development costs, 10 Table of Contents ALNYLAM PHARMACEUTICALS, INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain it or treat COVID-19, as well as the economic impact on local, regional, national and international customers and markets. We have made estimates of the impact of COVID-19 within our financial statements and there may be changes to those estimates in future periods. Actual results may differ from these estimates. Liquidity Based on our current operating plan, we believe that our cash, cash equivalents and marketable debt and equity securities as of June 30, 2020, together with the cash we expect to generate from product sales and under our alliances and strategic financing collaboration, will be sufficient to enable us to advance our long-term strategic goals for multiple years from the filing of this Quarterly Report on Form 10-Q. Liability Related to the Sale of Future Royalties We account for the liability related to the sale of future royalties as a debt financing, as we have significant continuing involvement in the generation of the cash flows. Interest on the liability related to the sale of future royalties will be recognized using the effective interest rate method over the life of the related royalty stream. The liability related to the sale of future royalties and the related interest expense are based on our current estimates of future royalties and commercial milestones expected to be paid over the life of the arrangement. We will periodically assess the expected payments and to the extent the amount or timing of our future estimated payments is materially different than our previous estimates, we will account for any such change by adjusting the liability related to the sale of future royalties and prospectively recognizing the related non-cash interest expense. Recently Adopted Accounting Pronouncements In June 2016, the Financial Accounting Standards Board, or FASB, issued new accounting guidance which requires entities to record expected credit losses for certain financial instruments, including trade receivables, as an allowance that reflects the entity's current estimate of credit losses expected to be incurred. For available-for-sale debt securities in unrealized loss positions, the new standard requires allowances to be recorded instead of reducing the amortized cost of the investment. The new standard became effective for us on January 1, 2020 and did not have a significant impact on our condensed consolidated financial statements and related disclosures. In August 2018, the FASB issued amendments to accounting guidance that eliminate, add and modify certain disclosure requirements on fair value measurements. The new standard became effective for us on January 1, 2020 and did not have a significant impact on our condensed consolidated financial statements and related disclosures. In August 2018, the FASB issued new accounting guidance to clarify the accounting for implementation costs in cloud computing arrangements (hosting arrangements). The new standard requires a customer in a cloud computing arrangement to determine which implementation costs to capitalize as assets or expense as incurred. Capitalized implementation costs related to a hosting arrangement that is a service contract will be amortized over the term of the hosting arrangement, beginning when the module or component of the hosting arrangement is ready for its intended use. The new standard became effective for us on January 1, 2020 and did not have a significant impact on our condensed consolidated financial statements and related disclosures. In November 2018, the FASB issued new accounting guidance to clarify the interaction between the accounting guidance for collaborative arrangements and revenue from contracts with customers. The new standard became effective for us on January 1, 2020 using a retrospective transition method. This standard did not have a significant impact on our condensed consolidated financial statements and related disclosures. In December 2019, the FASB issued amendments to accounting guidance that simplify the accounting for income taxes, as part of its initiative to reduce complexity in the accounting standards. The amendments eliminate certain exceptions related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences. The amendments also clarify and simplify other aspects of the accounting for income taxes. We early adopted the amendments as of January 1, 2020, on a prospective basis. The amendments did not have a significant impact on our condensed consolidated financial statements and related disclosures. 11 Table of Contents ALNYLAM PHARMACEUTICALS, INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) 3. NET PRODUCT REVENUES Net product revenues consist of the following: Three Months Ended June 30, Six Months Ended June 30, (In thousands) 2020 2019 2020 2019 United States $ 40,929 $ 28,192 $ 83,399 $ 46,952 Europe 25,357 10,039 46,523 17,570 Rest of World (primarily Japan) 11,247 — 19,549 — Total $ 77,533 $ 38,231 $ 149,471 $ 64,522 Three Months Ended June 30, Six Months Ended June 30, (In thousands) 2020 2019 2020 2019 ONPATTRO $ 66,535 $ 38,231 $ 133,199 $ 64,522 GIVLAARI 10,998 — 16,272 — Total $ 77,533 $ 38,231 $ 149,471 $ 64,522 The following table presents the balance of our receivables related to our net product revenues: (In thousands) As of June 30, 2020 As of December 31, 2019 Receivables included in “Accounts receivable, net” $ 59,250 $ 28,082 4. NET REVENUES FROM COLLABORATIONS Net revenues from collaborations consist of the following: Three Months Ended June 30, Six Months Ended June 30, (In thousands) 2020 2019 2020 2019 Regeneron Pharmaceuticals (Regeneron) $ 15,413 $ 700 $ 34,916 $ 700 Vir Biotechnology (Vir) 6,448 1,091 12,964 2,019 The Medicines Company (MDCO) 3,878 — 4,938 1,745 Sanofi Genzyme (Sanofi) 373 4,383 373 8,500 Other 317 309 776 522 Total $ 26,429 $ 6,483 $ 53,967 $ 13,486 The following table presents the balance of our receivables and contract liabilities related to our collaboration agreements: (In thousands) As of June 30, 2020 As of December 31, 2019 Receivables included in “Accounts receivable, net” $ 9,865 $ 14,929 Contract liabilities included in “Deferred revenue” $ 152,258 $ 153,117 The following table presents revenue recognized as a result of changes in contract liability related to our collaboration agreements: Three Months Ended June 30, Six Months Ended June 30, (In thousands) 2020 2019 2020 2019 Amounts included in contract liability at the beginning of the period $ 16,826 $ 1,091 $ 31,504 $ 2,019 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 12 Table of Contents ALNYLAM PHARMACEUTICALS, INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) 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 research and development expenses incurred by type, for which we recognize net revenue, that are directly attributable to our collaboration agreements, by collaboration partner: Three Months Ended June 30, 2020 2019 (In thousands) Clinical Trial and Manufacturing External Services Other Clinical Trial and Manufacturing External Services Other Regeneron $ 2,784 $ 24 $ 12,632 $ 515 $ 51 $ 425 Vir 1,039 157 3,599 248 12 211 MDCO — — 278 65 — 10 Sanofi 199 12 165 2,945 81 34 Total $ 4,022 $ 193 $ 16,674 $ 3,773 $ 144 $ 680 Six Months Ended June 30, 2020 2019 (In thousands) Clinical Trial and Manufacturing External Services Other Clinical Trial and Manufacturing External Services Other Regeneron $ 7,396 $ 24 $ 24,123 $ 515 $ 51 $ 425 Vir 1,378 209 5,292 542 248 340 MDCO 998 — 544 1,677 10 60 Sanofi 199 29 396 7,771 216 93 Total $ 9,971 $ 262 $ 30,355 $ 10,505 $ 525 $ 918 The research and development expenses incurred for each agreement listed in the table above consist of costs incurred for (i) clinical and manufacturing expenses, (ii) external services including consulting services and lab supplies and services, and (iii) other expenses, including professional services, facilities and overhead allocations, and a reasonable estimate of compensation and related costs as billed to our counterparties, for which we recognize net revenue from collaborations. For the three and six months ended June 30, 2020 and 2019, we did not incur material selling, general and administrative expenses related to our collaboration agreements. Product Alliances Vir Biotechnology, Inc. In October 2017, we and Vir Biotechnology, Inc., or Vir, entered into a collaboration and license agreement, or the Vir Agreement, for the development and commercialization of RNAi therapeutics for infectious diseases, including chronic hepatitis B virus, or HBV, infection. Pursuant to the Vir Agreement, we granted to Vir an exclusive license to develop, manufacture and commercialize ALN-HBV02 (VIR-2218), for all uses and purposes other than certain excluded fields, as set forth in the Vir Agreement. In addition, we granted Vir an exclusive option for up to four additional RNAi therapeutic programs for the treatment of infectious diseases. Under the terms of the Vir Agreement, for each product arising from the HBV program, including ALN-HBV02, we retain the right to opt into a profit-sharing arrangement prior to the start of a Phase 3 clinical trial. In addition, we have the right on a product-by-product basis with respect to each additional infectious disease program that Vir elects to pursue, to opt into a profit-sharing arrangement for each such product at any time during a specified period prior to the achievement of clinical proof of concept for each such product. Pursuant to the Vir Agreement, Vir paid us an upfront fee of $ 10.0 million and issued to us 1,111,111 shares of its common stock. Under the Vir Agreement, we may also receive milestone payments upon the achievement of certain development, regulatory and commercial milestones, as well as royalties on the net sales of licensed products, if any, ranging from high-single-digit to sub-teen double-digit percentages. In March 2020, we achieved a development milestone relating to ALN-HBV02 and earned a $ 15.0 million cash milestone and 1,111,111 shares of Vir's common stock, which were received in the 13 Table of Contents ALNYLAM PHARMACEUTICALS, INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) second quarter of 2020. In June 2020, we achieved a $ 10.0 million milestone payment from Vir related to Vir's sublicensee option exercise on ALN-HBV02. 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 under the Vir Agreement. In March and April 2020, we entered into amendments to the Vir Agreement to expand our collaboration to include the development and commercialization of RNAi therapeutics targeting SARS-CoV-2, the virus that causes the disease COVID-19, along with three additional targets focused on human host factors for SARS-CoV-2, including angiotensin converting enzyme-2, or ACE2 and transmembrane protease, serine 2, or TMPRSS2, and potentially a third mutually selected host factor target. Under the Vir amendments, we and Vir will each be responsible for pre-clinical development costs incurred by each such party in performing its allocated responsibilities under an agreed-upon initial pre-clinical development plan. We and Vir will equally share costs incurred in connection with the manufacture of non-GMP drug product required for pre-clinical development prior to filing an IND for the first product in the coronavirus program. Vir will lead all development and commercialization of any selected development candidates. At clinical proof of concept, we will have an option to share equally in the profits and losses associated with the development and commercialization of the coronavirus program. Alternatively, we may elect to earn development and commercialization milestones and royalties on net sales of products resulting from the collaboration in amounts agreed upon for the coronavirus program. Unless terminated earlier in accordance with the terms of the agreement, the Vir Agreement expires on a licensed product-by-product and country-by-country basis upon expiration of all royalty payment obligations under the agreement. If Vir does not exercise its option for an infectious disease program, the Vir Agreement will expire upon the expiration of the applicable option period with respect to such program. However, if we exercise our profit-sharing option for any product, the term of the agreement will continue until the expiration of the profit-sharing arrangement for such product. Either party may terminate the agreement in the event the other party fails to cure a material breach, or upon patent-related challenges by the other party. In addition, Vir has the right to terminate the agreement on a program-by-program basis or in its entirety for any reason on 90 days’ written notice. We identified one performance obligation under the Vir Agreement, as amended, comprised of: i) the exclusive license to develop, manufacture and commercialize RNAi therapeutics (including ALN-HBV02 and other infectious diseases); ii) the obligation to deliver four additional development candidates and supply product for each of the RNAi therapeutic programs for the treatment of infectious diseases; and iii) the obligation to deliver up to four development candidates and supply product for RNAi therapeutic programs targeting SARS-CoV-2. The license is not distinct from the services, including the obligation to deliver development candidates and supply product, as Vir cannot benefit on its own from the value of the license without receipt of such services and supply. We measure proportional performance over time using an input method based on cost incurred relative to the total estimated costs for the identified performance obligation, on a quarterly basis, by determining the proportion of effort incurred as a percentage of total effort we expect to expend. This ratio is applied to the total transaction price. Management has applied significant judgment in the process of developing our estimates. Any changes to these estimates will be recognized in the period in which they change as a cumulative catch up. We re-evaluate the transaction price as of the end of each reporting period and as of June 30, 2020, the total transaction price was determined to be $ 143.6 million, an increase of $ 38.4 million from the transaction price of $ 105.2 million as of March 31, 2020. As of June 30, 2020, the transaction price is comprised of the upfront payment, fair value of non-cash equity consideration at contract inception, milestones achieved and variable consideration related to development, manufacture and supply activities. The total transaction price is allocated entirely to the single performance obligation. We utilized the expected value method to determine the amount of reimbursement for these activities. We determined any variable consideration related to sales-based royalties and milestones related to the exclusive license to be constrained and therefore excluded such consideration from the transaction price. As of June 30, 2020, the aggregate amount of the transaction price allocated to the performance obligation that was unsatisfied was $ 103.7 million, which is expected to be recognized through the term of the Vir Agreement as the services are performed. Regeneron Pharmaceuticals, Inc. On April 8, 2019, we entered into a global, strategic collaboration with Regeneron Pharmaceuticals, Inc., or Regeneron, to discover, develop and commercialize RNAi therapeutics for a broad range of diseases by addressing therapeutic targets expressed in the eye and central nervous system, or CNS, in addition to a select number of targets expressed in the liver, which we refer to as the Regeneron Collaboration. The Regeneron Collaboration is governed by a Master Agreement, referred to as the Regeneron Master Agreement, which became effective on May 21, 2019, or the Effective Date. In connection with the Regeneron Master Agreement, we and Regeneron entered into (i) a binding co-co collaboration term sheet covering the continued development of cemdisiran, our C5 small interfering RNA, or siRNA, currently in Phase 2 development for C5 14 Table of Contents ALNYLAM PHARMACEUTICALS, INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) complement-mediated diseases, as a monotherapy and (ii) a binding license term sheet to evaluate anti-C5 antibody-siRNA combinations for C5 complement-mediated diseases including evaluating the combination of Regeneron’s pozelimab (REGN3918), currently in Phase 1 development, and cemdisiran. The C5 co-co collaboration and license agreements were executed in August 2019. Under the terms of the Regeneron Collaboration, we are working exclusively with Regeneron to discover RNAi therapeutics for eye and CNS diseases for an initial five -year research period, which we refer to as the Initial Research Term. Regeneron has an option to extend the Initial Research Term (referred to as the Research Term Extension Period, and together with the Initial Research Term, the Research Term) for up to an additional two years , for a research term extension fee of up to $ 400.0 million. The Regeneron Collaboration also covers a select number of RNAi therapeutic programs designed to target genes expressed in the liver, including our previously announced collaboration with Regeneron to identify RNAi therapeutics for the chronic liver disease nonalcoholic steatohepatitis. We retain broad global rights to all of our other unpartnered liver-directed clinical and pre-clinical pipeline programs. The Regeneron Collaboration is governed by a joint steering committee that is comprised of an equal number of representatives from each party. Regeneron will lead development and commercialization for all programs targeting eye diseases (subject to limited exceptions), entitling us to certain potential milestone and royalty payments pursuant to the terms of a license agreement, the form of which has been agreed upon by the parties. We and Regeneron will alternate leadership on CNS and liver programs, with the lead party retaining global development and commercial responsibility. For CNS and liver programs, both we and Regeneron will have the option at lead candidate selection to enter into a co-co collaboration agreement, the form of which has been agreed upon by the parties, whereby both companies will share equally all costs of, and profits from, all development and commercialization activities under the program. If the non-lead party elects to not enter into a co-co collaboration agreement with respect to a given CNS or liver program, we and Regeneron will enter into a license agreement with respect to such program and the lead party will be the “Licensee” for the purposes of the license agreement. If the lead party for a CNS or liver program elects to not enter into the co-co collaboration agreement, then we and Regeneron will enter into a license agreement with respect to such program and leadership of the program will transfer to the other party and the former non-lead party will be the “Licensee” for the purposes of the license agreement. With respect to the programs directed to C5 complement-mediated diseases, we retain control of cemdisiran monotherapy development, and Regeneron is leading combination product development. Under the C5 co-co collaboration agreement, we and Regeneron equally share costs and potential future profits on any monotherapy program. Under the C5 license agreement, for cemdisiran to be used as part of a combination product, Regeneron is solely responsible for all development and commercialization costs and we will receive low double-digit royalties and commercial milestones of up to $ 325.0 million on any potential combination product sales. The C5 co-co collaboration agreement, the C5 license agreement, and the Master Agreement have been combined for accounting purposes and treated as a single agreement. In connection with the Regeneron Master Agreement, Regeneron made an upfront payment of $ 400.0 million. We are also eligible to receive up to an additional $ 200.0 million in milestone payments upon achievement of certain criteria during early clinical development for eye and CNS programs. We and Regeneron plan to advance programs directed to up to 30 targets under the Regeneron Collaboration during the Initial Research Term. For each program, Regeneron will provide us with $ 2.5 million in funding at program initiation and an additional $ 2.5 million at lead candidate identification, with the potential for approximately $ 30.0 million in annual discovery funding to us as the Regeneron Collaboration reaches steady state. Regeneron has the right to terminate the Regeneron Master Agreement for convenience upon ninety days ’ notice. The termination of the Regeneron Master Agreement does not affect the term of any license agreement or co-co collaboration agreement then in effect. In addition, either party may terminate the Regeneron Master Agreement for a material breach by, or insolvency of, the other party. Unless earlier terminated pursuant to its terms, the Regeneron Master Agreement will remain in effect with respect to each program until (a) such program becomes a terminated program or (b) the parties enter into a license agreement or co-co collaboration agreement with respect to such program. The Regeneron Master Agreement includes various representations, warranties, covenants, dispute escalation and resolution mechanisms, indemnities and other provisions customary for transactions of this nature. For any license agreement subsequently entered into, the licensee will generally be responsible for its own costs and expenses incurred in connection with the development and commercialization of the collaboration products. The licensee will pay to the licensor certain development and/or commercialization milestone payments totaling up to $ 150.0 million for each collaboration product. In addition, following the first commercial sale of the applicable collaboration product under a license agreement, the licensee is required to make certain tiered royalty payments, ranging from low double-digits up to 20 %, to the licensor based on the aggregate annual net sales of the collaboration product, subject to customary reductions. For any co-co collaboration agreement subsequently entered into, we and Regeneron will share equally all costs of, and profits from, development and commercialization activities. In the event that a party exercises its opt-out right, the lead party will be responsible for all costs and expenses incurred in connection with the development and commercialization of the 15 Table of Contents ALNYLAM PHARMACEUTICALS, INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) collaboration products under the applicable co-co collaboration agreement, subject to continued sharing of costs through defined points. If a party exercises its opt-out right, following the first commercial sale of the applicable collaboration product under a co-co collaboration agreement, the lead party is required to make certain tiered royalty payments, ranging from low double-digits up to 20 %, to the other party based on the aggregate annual net sales of the collaboration product and the timing of the exercise of the opt-out right, subject to customary reductions and a reduction for opt-out transition costs. Due to the uncertainty of pharmaceutical development and the high historical failure rates generally associated with drug development, we may not receive any milestone or royalty payments from Regeneron under the Regeneron Master Agreement, the C5 license agreement, or any future license agreement, or under any co-co collaboration agreement in the event we exercise our opt-out right. Our obligations under the Regeneron Collaboration include: (i) a research license and research services, collectively referred to as the Research Services Obligation; (ii) a worldwide license to cemdisiran for combination therapies, and manufacturing and supply, and development service obligations, collectively referred to as the C5 License Obligation; and (iii) development, manufacturing and commercialization activities for cemdisiran monotherapies, referred to as the C5 Co-Co Obligation. The research license is not distinct from the research services primarily as a result of Regeneron being unable to benefit on its own or with other resources reasonably available, as the license is providing access to specialized expertise, particularly as it relates to RNAi technology that is not available in the marketplace. Similarly, the worldwide license to cemdisiran for combination therapies is not distinct from the manufacturing and supply, and development service obligations, as Regeneron cannot benefit on its own from the value of the license without receipt of supply. Separately, the cemdisiran monotherapy co-co collaboration agreement is under the scope of ASC 808 as we and Regeneron are both active participants in the development and manufacturing activities and are exposed to significant risks and rewards that are dependent on commercial success of the activities of the arrangement. The development and manufacturing activities are a combined unit of account under the scope of ASC 808 and are not deliverables under ASC 606. The total transaction price is comprised of the $ 400.0 million upfront payment and additional variable consideration related to research, development, manufacturing and supply activities related to the Research Services Obligation and the C5 License Obligation. We utilized the expected value method to determine the amount of reimbursement for these activities. We determined that any variable consideration related to sales-based royalties and milestones related to the worldwide license to cemdisiran for combination therapies is deemed to be constrained and therefore has been excluded from the transaction price. In addition, we are eligible to receive future milestones upon the achievement of certain criteria during early clinical development for the eye and CNS programs. We are also eligible to receive royalties on future commercial sales for certain eye, CNS or liver targets, if any; however, these amounts are excluded from variable consideration under the Regeneron Collaboration as we are only eligible to receive such amounts if, after a drug candidate is identified, the form of license agreement is subsequently executed resulting in a license that is granted to Regeneron. Any such subsequently granted license would represent a separate transaction under ASC 606. We allocated the initial transaction price to each unit of account based on the applicable accounting guidance as follows, in thousands: Performance Obligations Standalone Selling Price Transaction Price Allocated Accounting Guidance Research Services Obligation $ 130,700 $ 183,100 ASC 606 C5 License Obligation 97,600 92,500 ASC 606 C5 Co-Co Obligation 364,600 246,000 ASC 808 $ 521,600 The transaction price was allocated to the obligations based on the relative estimated standalone selling prices of each obligation, over which management has applied significant judgment. We developed the estimated standalone selling price for the licenses included in the Research Services Obligation and the C5 License Obligation primarily based on the probability-weighted present value of expected future cash flows associated with each license related to each specific program. In developing such estimate, we applied judgment in the determination of the forecasted revenues, taking into consideration the applicable market conditions and relevant entity-specific factors, the expected number of targets or indications expected to be pursued under each license, the probability of success, the time needed to develop a product candidate pursuant to the associated license and the discount rate. We developed the estimated standalone selling price for the services and/or manufacturing and supply included in each of the obligations, as applicable, primarily based on the nature of the services to be performed and/or goods to be manufactured and estimates of the associated costs. The estimated standalone selling price of the C5 Co-Co Obligation was developed by estimating the present value of expected future cash flows that Regeneron is entitled to 16 Table of Contents ALNYLAM PHARMACEUTICALS, INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) receive. In developing such estimate, we applied judgment in determining the indications that will be pursued, the forecasted revenues for such indications, the probability of success and the discount rate. For the Research Services Obligation and the C5 License Obligation accounted for under ASC 606, we measure proportional performance over time using an input method based on cost incurred relative to the total estimated costs for each of the identified obligations, on a quarterly basis, by determining the proportion of effort incurred as a percentage of total effort we expect to expend. This ratio is applied to the transaction price allocated to each obligation. Management has applied significant judgment in the process of developing our estimates. Any changes to these estimates will be recognized in the period in which they change as a cumulative catch up. We re-evaluate the transaction price as of the end of each reporting period and during the quarter ended June 30, 2020, there was no change to the transaction price calculated at December 31, 2019. For the C5 Co-Co Obligation accounted for under ASC 808, the transaction price allocated to this obligation is recognized using a proportional performance method. Revenue recognized under this agreement, inclusive of the amount allocated to the C5 Co-Co Obligation and future cost reimbursements, is accounted for as collaboration revenue. The following table provides a summary of the transaction price allocated to each unit of account based on the applicable accounting guidance, in addition to revenue activity during the period, in thousands: Transaction Price Allocated Revenue Recognized During Deferred Revenue Performance Obligations As of June 30, 2020 Three Months Ended June 30, 2020 Six Months Ended June 30, 2020 As of June 30, 2020 As of December 31, 2019 Accounting Guidance Research Services Obligation $ 200,600 $ 10,300 $ 22,600 $ 67,100 $ 84,800 ASC 606 C5 License Obligation 108,500 — — 65,800 65,800 ASC 606 C5 Co-Co Obligation 246,000 2,900 7,100 236,000 243,000 ASC 808 $ 555,100 $ 13,200 $ 29,700 $ 368,900 $ 393,600 As of June 30, 2020, the aggregate amount of the transaction price allocated to the remaining Research Services Obligation and C5 License Obligation that was unsatisfied is $ 265.5 million, which is expected to be recognized through the term of the Regeneron Collaboration as the services are performed. This amount excludes the transaction price allocated to the C5 Co-Co Obligation accounted for under ASC 808. Deferred revenue related to the Regeneron Collaboration is classified as either current or non-current in the condensed consolidated balance sheets based on the period the revenue is expected to be recognized. The Medicines Company In February 2013, we and The Medicines Company, or MDCO, entered into a license and collaboration agreement pursuant to which we granted to MDCO an exclusive, worldwide license to develop, manufacture and commercialize RNAi therapeutics targeting proprotein convertase subtilisin/kexin type 9, or PCSK9, for the treatment of hypercholesterolemia and other human diseases, including inclisiran. We refer to this agreement, as amended through the date hereof, as the MDCO License Agreement. Under the MDCO License Agreement, MDCO paid us an upfront cash payment of $ 25.0 million. As of June 30, 2020, we have earned $ 30.0 million of development milestones and upon achievement of certain events, we will be entitled to receive additional milestone payments, up to an aggregate of $ 150.0 million, $ 50.0 million in specified regulatory milestones and $ 100.0 million in specified commercialization milestones. In addition, we will be entitled to royalties ranging from 10 % up to 20 % based on annual worldwide net sales, if any, of licensed products by MDCO, its affiliates and sublicensees, subject to reduction under specified circumstances. 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 under the MDCO License Agreement. The collaboration between us and MDCO is governed by a joint steering committee comprised of an equal number of representatives from each party. In April 2016, we and MDCO entered into a supply and technical transfer agreement to provide for our supply of inclisiran to MDCO, in accordance with the terms of the MDCO agreement. MDCO now has the sole right and responsibility to manufacture and supply inclisiran for development and commercialization under the MDCO development plan, subject to the terms of the MDCO agreement and the supply and technical transfer agreement. Unless terminated earlier in accordance with the terms of the agreement, the MDCO License Agreement expires on a licensed product-by-licensed product and country-by-country basis upon expiration of the last royalty term for any licensed product in any country, where a royalty term is defined as the latest to occur of (1) the expiration of the last valid claim of patent rights covering a licensed product, (2) the expiration of the Regulatory Exclusivity, as defined in the MDCO License Agreement, and (3) the twelfth anniversary of the first commercial sale of the licensed product in such country. We estimate 17 Table of Contents ALNYLAM PHARMACEUTICALS, INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) that our fundamental RNAi patents covering licensed products under the MDCO License Agreement will expire both in and outside of the U.S. generally between 2016 and 2028. We also estimate that our inclisiran product-specific patents covering licensed products under the MDCO License Agreement will expire in the U.S., Europe, China and Japan in 2036 and elsewhere at the end of 2033. These patent rights are subject to potential patent term extensions and/or supplemental protection certificates extending such terms in countries where such extensions may become available due to regulatory delay. In addition, more patent filings relating to the collaboration may be made in the future. We evaluated the MDCO License Agreement and concluded that MDCO meets the definition of a customer and that the MDCO License Agreement is a contract. We determined the transaction price, identified the performance obligations and allocated the transaction price to each performance obligation. We also determined that substantially all of our performance obligations are within the scope of the revenue standard as they relate to the delivery of goods and services to a customer for that customer’s use in monetizing an asset. Specifically, we concluded that MDCO meets the definition of a customer as we are delivering intellectual property and know-how rights as well as research and development activities. In addition, we determined that the MDCO License Agreement 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 MDCO. We determined that, pursuant to the 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 the MDCO License Agreement has a single identified or combined performance obligation. None of the unearned milestones are included in the transaction price, as all unearned milestone amounts are not considered likely of achievement and therefore 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 MDCO and as a result have also been excluded from the transaction price. During 2018, we completed the performance obligations identified in the MDCO License Agreement, including the supply and technical transfer agreement, however, we continue to receive additional orders for supply. We consider such orders as promised goods to be distinct from the other performance obligations since MDCO now has the ability to begin manufacturing on its own through its own vendors. Such option orders will be treated as separate agreements and any associated revenue will be recognized upon transfer of control. On January 6, 2020, Novartis AG completed its acquisition of MDCO. Sanofi Genzyme On April 8, 2019, we and Sanofi Genzyme entered into an amendment to our 2014 Sanofi Genzyme collaboration, which we refer to as the Collaboration Amendment. Under the Collaboration Amendment, we and Sanofi Genzyme agreed to conclude the research and option phase under our collaboration agreement. In connection and simultaneously with entering into the Collaboration Amendment, we and Sanofi Genzyme also entered into the Amended and Restated ALN-AT3 Global License Terms with respect to ALN-AT3 (fitusiran) and certain back-up products, which we refer to as the A&R AT3 License Terms. The A&R AT3 License Terms amend and restate the ALN-AT3 Global License Terms entered into by us and Sanofi Genzyme in January 2018 to modify certain of the business terms. The material collaboration terms for fitusiran, as previously announced, will continue unchanged. In connection with entering into the Collaboration Amendment and the A&R AT3 License Terms, we agreed to advance, at our cost, a selected investigational asset in an undisclosed rare genetic disease through the end of IND-enabling studies. Following completion of such studies, we will transition, at our cost, such asset to Sanofi Genzyme. Thereafter, Sanofi Genzyme will fund all potential future development and commercialization costs for such asset. If this asset is developed and approved, we will be eligible to receive tiered double-digit royalties on global net sales. No changes were made to our Exclusive License Agreement with Sanofi Genzyme, referred to as the Exclusive TTR License, pursuant to which we have global rights for the development and commercialization of ONPATTRO, together with vutrisiran and all back-up products, which remains in full force and effect. 5. LIABILITY RELATED TO THE SALE OF FUTURE ROYALTIES On April 10, 2020, we entered into a purchase and sale agreement, or Purchase Agreement, with BX Bodyguard Royalties L.P. (an affiliate of The Blackstone Group Inc.), or Blackstone Royalties, under which Blackstone Royalties acquired 50 % of royalties payable, or Royalty Interest, with respect to net sales by MDCO, its affiliates or sublicensees of inclisiran and any other licensed products under the MDCO License Agreement, and 75 % of the commercial milestone payments payable under the MDCO License Agreement, together with the Royalty Interest, the Purchased Interest. If Blackstone Royalties does not receive payments in respect of the Royalty Interest by December 31, 2029, equaling at least $ 1.00 billion, Blackstone Royalties 18 Table of Contents ALNYLAM PHARMACEUTICALS, INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) will receive 55 % of the Royalty Interest beginning on January 1, 2030. In consideration for the sale of the Purchased Interest, Blackstone Royalties paid us $ 500.0 million in April 2020 and has an unconditional obligation to pay us an additional $ 500.0 million on September 30, 2021, which was recorded as a receivable upon execution of the Purchase Agreement. We continue to own or control all inclisiran intellectual property rights and are responsible for certain ongoing manufacturing and supply obligations related to the generation of the Purchased Interest. Due to our continuing involvement, we will continue to account for any royalties and commercial milestones due to us under the MDCO License Agreement as revenue in our condensed consolidated statement of operations and comprehensive loss and recorded the proceeds from this transaction as a liability, net of closing costs, on our condensed consolidated balance sheet. In order to determine the amortization of the liability related to the sale of future royalties, we are required to estimate the total amount of future payments to Blackstone Royalties over the life of the Purchase Agreement. The $ 1.00 billion liability, recorded at execution of the agreement, will be accreted to the total of these royalty and commercial milestone payments as interest expense over the life of the Purchase Agreement. At execution, our estimate of this total interest expense resulted in an effective annual interest rate of 11 %. This estimate contains assumptions that impact both the amount recorded at execution and the interest expense that will be recognized in future periods. As payments are made to Blackstone Royalties, the balance of the liability will be effectively repaid over the life of the Purchase Agreement. As inclisiran is not yet approved for sale, the exact timing and amount of repayment is likely to change each reporting period. A significant increase or decrease in net sales of inclisiran will materially impact the liability related to the sale of future royalties, interest expense and the time period for repayment. We will periodically assess the expected payments to Blackstone Royalties and to the extent the amount or timing of such payments is materially different than our initial estimates, we will prospectively adjust the amortization of the liability related to the sale of future royalties and the related interest expense. As of June 30, 2020, the carrying value of the liability related to the sale of future royalties was $ 1.01 billion, net of closing costs of $ 13.0 million. The carrying value of the liability related to the sale of future royalties approximates fair value as of June 30, 2020 and is based on our current estimates of future royalties and commercial milestones expected to be paid to Blackstone Royalties over the life of the arrangement, which are considered Level 3 inputs. For the three and six months ended June 30, 2020, we recognized interest expense of $ 27.2 million. The following table shows the activity with respect to the liability related to the sale of future royalties during the three months ended June 30, 2020, in thousands: Liability related to the sale of future royalties as of April 10, 2020 $ 1,000,000 Capitalized closing costs ( 12,955 ) Interest expense recognized 27,248 Carrying value of liability related to sale of future royalties as of June 30, 2020 $ 1,014,293 19 Table of Contents ALNYLAM PHARMACEUTICALS, INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) 6. FAIR VALUE MEASUREMENTS The following tables present information about our assets that are measured at fair value on a recurring basis and indicate the fair value hierarchy of the valuation techniques we utilized to determine such fair value: (In thousands) As of June 30, 2020 Quoted Prices in Active Markets (Level 1) Significant Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Cash equivalents: U.S. treasury securities $ 9,999 $ — $ 9,999 $ — Money market funds 425,769 425,769 — — Marketable debt securities: Commercial paper 11,613 — 11,613 — Corporate notes 62,763 — 62,763 — U.S. government-sponsored enterprise securities 244,071 — 244,071 — U.S. treasury securities 939,978 — 939,978 — Marketable equity securities 86,310 45,522 40,788 — Restricted cash (money market funds) 1,483 1,483 — — Total $ 1,781,986 $ 472,774 $ 1,309,212 $ — (In thousands) As of December 31, 2019 Quoted Prices in Active Markets (Level 1) Significant Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Cash equivalents: Commercial paper $ 3,439 $ — $ 3,439 $ — U.S. treasury securities 336,693 — 336,693 — Money market funds 119,882 119,882 — — Marketable debt securities: Certificates of deposit 4,301 — 4,301 — Commercial paper 36,474 — 36,474 — Corporate notes 146,040 — 146,040 — U.S. government-sponsored enterprise securities 32,488 — 32,488 — U.S. treasury securities 755,714 — 755,714 — Marketable equity securities 13,967 13,967 — — Restricted cash (money market funds) 1,482 1,482 — — Total $ 1,450,480 $ 135,331 $ 1,315,149 $ — During the six months ended June 30, 2020 and 2019, there were no transfers between Level 1 and Level 2 financial assets. The carrying amounts reflected in our condensed consolidated balance sheets for cash, accounts receivable, net, other current assets, accounts payable and accrued expenses approximate fair value due to their short-term maturities. In March 2020, pursuant to the Vir Agreement, we achieved a development milestone relating to ALN-HBV02 and earned a $ 15.0 million cash milestone and 1,111,111 shares of Vir's common stock, which were received in the second quarter of 2020. As a result of certain securities law restrictions, our Vir common stock is subject to a 180 -day holding period. As such, we have recorded the investment at fair value, with the effect of the holding period restriction estimated using an option pricing valuation model, which is considered a Level 2 input. During the second quarter of 2020, we recognized an unrealized loss of $ 4.7 million to adjust our investment in Vir common stock to fair value as of June 30, 2020. 7. MARKETABLE DEBT SECURITIES We invest our excess cash balances in marketable debt securities and at each balance sheet date presented, we classify all of our investments in debt securities as available-for-sale and as current assets as they represent the investment of funds 20 Table of Contents ALNYLAM PHARMACEUTICALS, INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) available for current operations. We did no t record any impairment charges related to our marketable debt securities during the three and six months ended June 30, 2020 or 2019. The following tables summarize our marketable debt securities: As of June 30, 2020 (In thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Commercial paper $ 11,613 $ — $ — $ 11,613 Corporate notes 62,590 175 ( 2 ) 62,763 U.S. government-sponsored enterprise securities 243,907 197 ( 33 ) 244,071 U.S. treasury securities 947,928 2,140 ( 91 ) 949,977 Total $ 1,266,038 $ 2,512 $ ( 126 ) $ 1,268,424 As of December 31, 2019 (In thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Certificates of deposit $ 4,303 $ — $ ( 2 ) $ 4,301 Commercial paper 39,913 — — 39,913 Corporate notes 146,016 58 ( 34 ) 146,040 U.S. government-sponsored enterprise securities 32,487 3 ( 2 ) 32,488 U.S. treasury securities 1,092,293 185 ( 71 ) 1,092,407 Total $ 1,315,012 $ 246 $ ( 109 ) $ 1,315,149 The fair values of our marketable debt securities by classification in the condensed consolidated balance sheets were as follows: (In thousands) As of June 30, 2020 As of December 31, 2019 Cash and cash equivalents $ 9,999 $ 340,132 Marketable debt securities 1,258,425 975,017 Total $ 1,268,424 $ 1,315,149 8. OTHER BALANCE SHEET DETAILS The components of inventory are summarized as follows: (In thousands) As of June 30, 2020 As of December 31, 2019 Raw materials $ 43,515 $ 15,418 Work in progress 20,686 38,275 Finished goods 13,217 2,655 Total $ 77,418 $ 56,348 As of June 30, 2020, we capitalized $ 11.5 million of inventory produced for commercial sale for products awaiting regulatory approval. As of December 31, 2019, there was no capitalized inventory for products awaiting regulatory approval. 21 Table of Contents ALNYLAM PHARMACEUTICALS, INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within our condensed consolidated balance sheets that sum to the total of these amounts shown in the condensed consolidated statements of cash flows: As of June 30, (In thousands) 2020 2019 Cash and cash equivalents $ 580,829 $ 1,136,289 Restricted cash included in prepaid expenses and other current assets 5 332 Restricted cash included in long-term other assets 2,447 2,983 Total cash, cash equivalents, and restricted cash shown in the condensed consolidated statements of cash flows $ 583,281 $ 1,139,604 The following tables summarize the changes in accumulated other comprehensive (loss) income, by component: (In thousands) Loss on Investment in Joint Venture Defined Benefit Pension Plans Unrealized Gains from Debt Securities Foreign Currency Translation Adjustment Total Accumulated Other Comprehensive Loss Balance as of December 31, 2019 $ ( 32,792 ) $ ( 3,520 ) $ 137 $ ( 343 ) $ ( 36,518 ) Other comprehensive income before reclassifications — — 2,138 911 3,049 Amounts reclassified from other comprehensive income — 146 111 — 257 Net other comprehensive income — 146 2,249 911 3,306 Balance as of June 30, 2020 $ ( 32,792 ) $ ( 3,374 ) $ 2,386 $ 568 $ ( 33,212 ) (In thousands) Loss on Investment in Joint Venture Defined Benefit Pension Plans Unrealized Losses from Debt Securities Foreign Currency Translation Adjustment Total Accumulated Other Comprehensive Loss Balance as of December 31, 2018 $ ( 32,792 ) $ — $ ( 421 ) $ — $ ( 33,213 ) Other comprehensive income before reclassifications — ( 4,282 ) 478 842 ( 2,962 ) Amounts reclassified from other comprehensive income — — 344 — 344 Net other comprehensive income (loss) — ( 4,282 ) 822 842 ( 2,618 ) Balance as of June 30, 2019 $ ( 32,792 ) $ ( 4,282 ) $ 401 $ 842 $ ( 35,831 ) Amounts reclassified out of accumulated other comprehensive loss relate to settlements of marketable debt securities and amortization of our pension obligation which are recorded as interest income and other income, respectively, in the condensed consolidated statements of operations and comprehensive loss. 9. CREDIT AGREEMENT On April 10, 2020, we entered into the Credit Agreement among us, certain of our subsidiaries (such subsidiaries, together with us, the Loan Parties), funds or accounts managed or advised by GSO Capital Partners LP and certain other affiliates of T he Blackstone Group Inc. , and the other lenders from time to time parties thereto, collectively, the Lenders, and Wilmington Trust, National Association, as the administrative agent for the Lenders. The Credit Agreement provides for a senior secured delayed 22 Table of Contents ALNYLAM PHARMACEUTICALS, INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) draw term loan facility of up to $ 700.0 million to be funded in three tranches, collectively referred to as the Term Loans, as follows: Tranche Requested No Later Than Aggregate Principal Amount, up to (in thousands) Tranche 1 Loan December 31, 2020 $ 200,000 Tranche 2 Loan June 30, 2021 250,000 Tranche 3 Loan December 31, 2021 250,000 Total $ 700,000 In addition, we may (a) at any time following April 10, 2021, request an increase in respect of the unfunded commitments in an amount not to exceed $ 50.0 million on terms to be agreed and subject to the consent of the Lenders providing such increase and/or (b) at any time prior to April 10, 2021, cancel the unfunded commitments or reallocate the unfunded commitments in respect of the Tranche 2 Loan or Tranche 3 Loan to the Tranche 1 Loan and/or the Tranche 2 Loan in an amount not to exceed $ 100.0 million in the aggregate for all such cancellations or reallocations. The Tranche 1 Loan will be requested no later than December 31, 2020, the Tranche 2 Loan will be requested no later than June 30, 2021 and the Tranche 3 Loan will be requested no later than December 31, 2021, in each case, subject to customary terms and conditions, including, in the case of the Tranche 2 Loan and Tranche 3 Loan, either (a) the first sale of inclisiran in the U.S. for end use or consumption after FDA regulatory approval thereof or (b) revenue attributable to ONPATTRO and GIVLAARI equal to or greater than $ 300.0 million as of the last day of the most recently ended twelve month period, referred to as the Subsequent Borrowing Conditions. In the event the Subsequent Borrowing Conditions are not satisfied as of the dates set forth in the table above, the Tranche 2 Loan and Tranche 3 Loan will be funded if such Subsequent Borrowing Conditions are satisfied on or prior to December 31, 2022. The Term Loans mature seven years from the date the Tranche 1 Loan is funded, referred to as the Tranche 1 Funding Date. We can elect an interest rate of either LIBOR plus 7 %, subject to a floor of 1 %, or a base rate plus 6 %, subject to a floor of 2 %. We may, at our option, pay interest in kind on interest due within a three -year period beginning on the Tranche 1 Funding Date at a rate that is 1 % higher than the interest rate otherwise applicable to such Term Loan . On the date any Tranche 1 Loan, Tranche 2 Loan or Tranche 3 Loan is funded, we will pay a funding fee equal to 2.5 % of the principal amount of the Term Loans funded on such date. In addition, we will pay an exit fee equal to 1 % of the commitments in respect of the Term Loans, payable upon any repayment of the Term Loans or termination of the unfunded Term Loan commitments. We are obligated to pay interest due on the Term Loans for a two -year period beginning on the Tranche 1 Funding Date which will be calculated without regard to the Term Loans being prepaid or an unfunded tranche being terminated during this period (in whole or in part). Any prepayments of Term Loans or terminations of unfunded tranches that occur between 2 to 5 years from the Tranche 1 Funding Date are subject to a fee of up to 5 % of the loan principal that is prepaid or the amount of the unfunded tranche that is terminated. All obligations under the Credit Agreement are secured, subject to certain exceptions, by security interests in the following assets: (1) intellectual property owned by us relating to ONPATTRO, GIVLAARI and vutrisiran, (2) the equity interests held by the Loan Parties in their subsidiaries, (3) all of our ownership of the inclisiran royalty remaining after the royalty purchase under the Purchase Agreement, and (4) material real property, and certain personal property, including, without limitation, cash held in certain deposit accounts of the Loan Parties and equipment. The Credit Agreement contains negative covenants that, among other things and subject to certain exceptions, could restrict our ability to, incur additional liens, incur additional indebtedness, make investments, including acquisitions, engage in fundamental changes, sell or dispose of assets that constitute collateral, including certain intellectual property, pay dividends or make any distribution or payment on or redeem, retire or purchase any equity interests, amend, modify or waive certain material agreements or organizational documents and make payments of certain subordinated indebtedness. Additionally, the Credit Agreement contains certain customary representations and warranties, affirmative covenants and provisions relating to events of default, including nonpayment of principal, interest and other amounts; failure to comply with covenants; the rendering of judgments or orders or default by us in respect of other material indebtedness; and certain insolvency and ERISA events. The Credit Agreement also requires us to have consolidated liquidity of at least $ 100.0 million as of the last day of each fiscal quarter. As of June 30, 2020, we were in compliance with the applicable terms and conditions of the covenants under the Credit Agreement. No later than December 31, 2020, we will draw the Tranche 1 Loan based on the terms of the Credit Agreement. As of June 30, 2020, we had not yet drawn down on the Term Loans. 23 Table of Contents ALNYLAM PHARMACEUTICALS, INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) 10. EQUITY Blackstone Equity Placement On April 10, 2020, we entered into a stock purchase agreement, or Investors SPA, with certain affiliates of The Blackstone Group Inc., or Investors, pursuant to which we sold 963,486 shares of our common stock to the Investors for aggregate cash consideration of $ 100.0 million, or $ 103.79 per share, as part of the broad strategic financing collaboration with The Blackstone Group Inc. The Investors SPA contains customary representations, warranties, and covenants of each of the parties thereto. Regeneron Equity Placement On April 8, 2019, we executed a stock purchase agreement with Regeneron, or the Regeneron SPA, to sell 4,444,445 shares of our common stock for aggregate cash consideration of $ 400.0 million, or $ 90.00 per share, which we refer to as the Equity Transaction. Under the terms of the Regeneron SPA, if at the time of closing of the Equity Transaction, a sufficient number of authorized shares of common stock under our Restated Certificate of Incorporation was not available, the $ 400.0 million of equity under the Regeneron SPA would instead have been issued in the form of 1,481,482 shares of our Series A redeemable convertible preferred stock, par value $ 0.01 per share, at a purchase price of $ 270.00 per share, that would have converted automatically into common stock on a 1-for- 3 basis upon stockholder approval of additional authorized shares of common stock. The Regeneron SPA contains customary representations, warranties and covenants of each of the parties thereto. On April 25, 2019, following the receipt of stockholder approval at our 2019 annual meeting, a Certificate of Amendment was filed to our Restated Certificate of Incorporation to increase the number of authorized shares of common stock from 125,000,000 to 250,000,000 shares, providing for a sufficient number of authorized shares of common stock available to be issued to Regeneron pursuant to the Equity Transaction. On May 21, 2019, subsequent to the expiration of the applicable pre-merger waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, Regeneron purchased 4,444,445 shares of our common stock for aggregate cash consideration of $ 400.0 million. Because we had an obligation to Regeneron as of April 8, 2019 that may have resulted in the issuance of redeemable convertible preferred stock, we were required to follow the guidance in ASC 480 and mark-to-market the obligation to potentially issue this redeemable security until April 25, 2019, when it became known that the obligation would be fulfilled in common stock. The final mark-to-market adjustment of this obligation under ASC 480 resulted in us recording a gain of $ 9.4 million included in other income in the consolidated statements of comprehensive loss during the three and six months ended June 30, 2019, with the offsetting adjustment to equity netting against the $ 400.0 million proceeds that were received upon closing. Public Offering In January 2019, 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 $ 77.50 per share. As a result of the offering, we received aggregate net proceeds of $ 381.9 million after deducting underwriting discounts and commissions and other offering expenses of approximately $ 5.6 million. 11. STOCK-BASED COMPENSATION The following table summarizes stock-based compensation expenses included in operating costs and expenses: Three Months Ended June 30, Six Months Ended June 30, (In thousands) 2020 2019 2020 2019 Research and development $ 15,790 $ 15,282 $ 31,839 $ 31,407 Selling, general and administrative 17,965 15,321 36,494 31,228 Total $ 33,755 $ 30,603 $ 68,333 $ 62,635 12. 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 during the period. 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 outstanding during the period. 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. 24 Table of Contents ALNYLAM PHARMACEUTICALS, INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) The following common share equivalents were excluded from the calculation of net loss per common share because their inclusion would be anti-dilutive: As of June 30, (In thousands) 2020 2019 Options to purchase common stock 12,437 13,771 Unvested restricted common stock 1,188 696 Total 13,625 14,467 13. COMMITMENTS AND CONTINGENCIES Litigation From time to time, we may be a party to litigation, arbitration or other 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 products or 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 or breach our license or other agreements with such third parties. 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. Our accounting policy for accrual of legal costs is to recognize such expenses as incurred. Securities Litigation On September 26, 2018, Caryl Hull Leavitt, individually and on behalf of all others similarly situated, filed a class action complaint for violation of federal securities laws against us, our Chief Executive Officer and our former Chief Financial Officer in the United States District Court for the Southern District of New York. By stipulation of the parties and Order of the Court dated November 20, 2018, the action was transferred to the United States District Court for the District of Massachusetts. On May 8, 2019, the Court entered an order appointing a lead plaintiff, and on July 3, 2019, lead plaintiff filed a consolidated class action complaint, or the Complaint. In addition to the originally named defendants, the Complaint also named as defendants certain of our other executive officers, and purported to be brought on behalf of a class of persons who acquired our securities between September 20, 2017 and September 12, 2018 and sought to recover damages caused by defendants’ alleged violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, and Rule 10b-5 promulgated thereunder. The Complaint alleged, among other things, that the defendants made materially false and misleading statements related to the efficacy and safety of our product, ONPATTRO. The plaintiff sought, among other things, the designation of this action as a class action, an award of unspecified compensatory damages, interest, costs and expenses, including counsel fees and expert fees, and other relief as the court deems appropriate. All defendants filed a motion to dismiss the Complaint in its entirety on July 31, 2019. The motion to dismiss was fully briefed on September 30, 2019. On March 23, 2020, the Court allowed our motion and dismissed the Complaint without prejudice. Pursuant to a prior Order of the Court, on June 1, 2020, plaintiff filed a motion seeking leave to file a further amended complaint. That motion was fully briefed on June 22, 2020, and remains pending with the Court. On September 12, 2019, the Chester County Employees Retirement Fund, individually and on behalf of all others similarly situated, filed a purported securities class action complaint for violation of federal securities laws against us, certain of our current and former directors and officers, and the underwriters of our November 14, 2017 public stock offering, in the Supreme Court of the State of New York, New York County. On November 7, 2019, plaintiff filed an amended complaint, or the New York Complaint. The New York Complaint is brought on behalf of an alleged class of those who purchased our securities pursuant and/or traceable to our November 14, 2017 public stock offering. The New York Complaint purports to allege claims arising under Sections 11, 12(a)(2) and 15 of the Securities Act of 1933, as amended, and generally alleges that the defendants violated the federal securities laws by, among other things, making material misstatements or omissions concerning the results of our APOLLO Phase 3 clinical trial of patisiran. The plaintiff seeks, among other things, the designation of the action as a class action, an award of unspecified compensatory damages, rescissory damages, interest, costs and expenses, including counsel fees and expert fees, and other relief as the court deems appropriate. All defendants filed a joint motion to dismiss the New York Complaint in its entirety on December 20, 2019. Plaintiff’s response to that motion was filed on February 3, 2020, and defendants filed a joint reply on March 4, 2020. On June 2, 2020, the Court heard oral argument on defendants' motion, at which time it took the motion under advisement. 25 Table of Contents ALNYLAM PHARMACEUTICALS, INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) We believe that the allegations contained in the complaints are without merit and intend to defend the cases vigorously. We cannot predict at this point the length of time that these actions will be ongoing or the liabilities, if any, which may arise therefrom. 14. DEFINED BENEFIT PLANS We maintain defined benefit plans for employees in certain countries outside the U.S., including retirement benefit plans required by applicable local law. The unfunded benefit obligation corresponds to the projected benefit obligations of which the discounted net present value is calculated based on years of employment, expected salary increases and pension adjustments, offset by the fair value of the assets held by plan. The unfunded benefit obligation was approximately $ 4.3 million as of June 30, 2020 and December 31, 2019, and is recorded in other liabilities on the condensed consolidated balance sheet. The total net periodic benefit cost for the three and six months ended June 30, 2020 and 2019 was not material. 26 Table of Contents