Item 1. Financial Statements
Item 1. Financial Statements
NOVAVAX, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share information)
March 31,
2021 December 31,
2020
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents $ 1,995,482 $ 553,398
Marketable securities 2,250 157,649
Restricted cash 32,128 93,880
Accounts receivable 56,898 262,012
Unbilled services 45,295 —
Prepaid expenses and other current assets 114,731 181,264
Total current assets 2,246,784 1,248,203
Restricted cash 1,460 1,460
Property and equipment, net 192,044 179,954
Intangible assets, net 5,270 5,725
Goodwill 130,879 135,379
Other non-current assets 31,929 11,758
Total assets $ 2,608,366 $ 1,582,479
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable $ 113,605 $ 54,332
Accrued expenses 148,611 142,468
Deferred revenue 822,809 273,228
Current portion of finance lease liabilities 121,144 105,862
Other current liabilities 2,386 3,782
Total current liabilities 1,208,555 579,672
Convertible notes payable 322,390 322,035
Non-current finance lease liabilities 16,696 40,083
Other non-current liabilities 21,598 13,480
Total liabilities 1,569,239 955,270
Commitments and contingencies
Preferred stock, $ 0.01 par value, 2,000,000 shares authorized at March 31, 2021 and December 31, 2020; no shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively
— —
Stockholders' equity:
Common stock, $ 0.01 par value, 600,000,000 shares authorized at March 31, 2021 and December 31, 2020; and 74,470,583 shares issued and 74,061,594 shares outstanding at March 31, 2021 and 71,350,365 shares issued and 70,953,739 shares outstanding at December 31, 2020
745 714
Additional paid-in capital 3,180,114 2,535,476
Accumulated deficit ( 2,096,918 ) ( 1,874,199 )
Treasury stock, 408,989 shares, cost basis at March 31, 2021 and 396,626 shares, cost basis at December 31, 2020
( 44,457 ) ( 41,806 )
Accumulated other comprehensive (loss) income ( 357 ) 7,024
Total stockholders’ equity 1,039,127 627,209
Total liabilities and stockholders’ equity $ 2,608,366 $ 1,582,479
The accompanying notes are an integral part of these financial statements.
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NOVAVAX, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share information)
(unaudited)
For the Three Months Ended
March 31,
2021 2020
Revenue:
Government contracts $ 382,704 $ —
Grant and other 64,525 3,377
Total revenue 447,229 3,377
Expenses:
Research and development 592,671 16,895
General and administrative 63,190 9,379
Total expenses 655,861 26,274
Loss from operations ( 208,632 ) ( 22,897 )
Other income (expense):
Investment income 362 436
Interest expense ( 4,839 ) ( 3,403 )
Other expense ( 6,593 ) —
Net loss before income tax expense $ ( 219,702 ) $ ( 25,864 )
Income tax expense 3,017 —
Net loss $ ( 222,719 ) $ ( 25,864 )
Basic and diluted net loss per share $ ( 3.05 ) $ ( 0.58 )
Basic and diluted weighted average number of common shares outstanding 73,035 44,421
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(in thousands)
(unaudited)
For the Three Months Ended
March 31,
2021 2020
Net loss $ ( 222,719 ) $ ( 25,864 )
Other comprehensive income (loss):
Net unrealized losses on marketable securities available-for-sale, net of reclassifications ( 9 ) ( 132 )
Foreign currency translation adjustment ( 7,372 ) ( 1,846 )
Other comprehensive loss ( 7,381 ) ( 1,978 )
Comprehensive loss $ ( 230,100 ) $ ( 27,842 )
The accompanying notes are an integral part of these financial statements.
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NOVAVAX, INC.
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (DEFICIT)
Three Months Ended March 31, 2021 and 2020
(unaudited)
Common Stock Additional
Paid-in
Capital Accumulated
Deficit Treasury
Stock Other
Comprehensive
Income (Loss) Stockholders'
Equity
(Deficit)
Shares Amount
(in thousands, except share information)
Balance at December 31, 2020 71,350,365 $ 714 $ 2,535,476 $ ( 1,874,199 ) $ ( 41,806 ) $ 7,024 $ 627,209
Non-cash stock-based compensation — — 53,060 — — — 53,060
Stock issued under incentive programs 541,251 5 26,745 — ( 2,651 ) — 24,099
Issuance of common stock, net of issuance costs of $ 7,292
2,578,967 26 564,833 — — — 564,859
Unrealized loss on marketable securities — — — — — ( 9 ) ( 9 )
Foreign currency translation adjustment — — — — — ( 7,372 ) ( 7,372 )
Net loss — — — ( 222,719 ) — — ( 222,719 )
Balance at March 31, 2021 74,470,583 $ 745 $ 3,180,114 $ ( 2,096,918 ) $ ( 44,457 ) $ ( 357 ) $ 1,039,127
Balance at December 31, 2019 32,399,352 $ 324 $ 1,260,551 $ ( 1,431,801 ) $ ( 2,583 ) $ ( 12,508 ) $ ( 186,017 )
Non-cash stock-based compensation — — 3,965 — — — 3,965
Stock issued under incentive programs 33,239 — 60 — ( 55 ) — 5
Issuance of common stock, net of issuance costs of $ 2,498
21,473,731 215 185,703 — — — 185,918
Unrealized loss on marketable securities — — — — — ( 132 ) ( 132 )
Foreign currency translation adjustment — — — — — ( 1,846 ) ( 1,846 )
Net loss — — — ( 25,864 ) — — ( 25,864 )
Balance at March 31, 2020 53,906,322 $ 539 $ 1,450,279 $ ( 1,457,665 ) $ ( 2,638 ) $ ( 14,486 ) $ ( 23,971 )
The accompanying notes are an integral part of these financial statements.
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NOVAVAX, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)
Three Months Ended
March 31,
2021 2020
Operating Activities:
Net loss $ ( 222,719 ) $ ( 25,864 )
Reconciliation of net loss to net cash used in operating activities:
Depreciation and amortization 2,317 925
Non-cash stock-based compensation 53,060 3,965
Right-of-use assets expensed 951 —
Other 6,362 356
Changes in operating assets and liabilities:
Receivables, prepaid expenses and other assets 220,205 4,521
Accounts payable and accrued expenses 53,325 ( 8,450 )
Deferred revenue 549,584 1,437
Net cash provided by (used in) operating activities 663,085 ( 23,110 )
Investing Activities:
Capital expenditures ( 13,781 ) ( 122 )
Purchases of marketable securities ( 2,167 ) ( 57,606 )
Proceeds from maturities and sale of marketable securities 157,557 —
Net cash provided by (used in) investing activities 141,609 ( 57,728 )
Financing Activities:
Net proceeds from sales of common stock 564,859 185,918
Proceeds from the exercise of stock-based awards 26,750 5
Treasury stock related to tax withholding on stock-based awards ( 2,651 ) —
Finance lease payments ( 11,971 ) —
Net cash provided by financing activities 576,987 185,923
Effect of exchange rate on cash, cash equivalents and restricted cash ( 1,349 ) ( 73 )
Net increase in cash, cash equivalents and restricted cash 1,380,332 105,012
Cash, cash equivalents and restricted cash at beginning of period 648,738 82,180
Cash, cash equivalents and restricted cash at end of period $ 2,029,070 $ 187,192
Supplemental disclosure of non-cash activities:
Capital expenditures included in accounts payable and accrued expenses $ 9,076 $ 125
Right-of-use assets from new lease agreements $ 9,770 $ —
Supplemental disclosure of cash flow information:
Cash interest payments $ 7,530 $ 6,094
Cash paid for income taxes $ 3,017 $ —
The accompanying notes are an integral part of these financial statements.
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NOVAVAX, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
March 31, 2021
(unaudited)
Note 1 – Organization
Novavax, Inc. (“Novavax,” and together with its wholly owned subsidiaries, Novavax AB and Novavax CZ, the “Company”) is a biotechnology company that promotes improved global health through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases and address urgent, global health needs. The Company’s vaccine candidates, including both its coronavirus vaccine candidate, NVX-CoV2373, and its lead influenza vaccine candidate, NanoFlu TM , are genetically engineered, three-dimensional nanostructures of recombinant proteins critical to disease pathogenesis and may elicit differentiated immune responses, which may be more efficacious than naturally occurring immunity or traditional vaccines. NVX-CoV2373 and NanoFlu include the use of the Company's proprietary Matrix-M™ adjuvant.
Note 2 – Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) for interim financial information and the instructions to Form 10-Q and Article 10 of Regulation S-X. The consolidated balance sheet as of March 31, 2021, the consolidated statements of operations and the consolidated statements of comprehensive loss for the three months ended March 31, 2021 and 2020, the consolidated statements of changes in stockholders’ equity (deficit) for the three months ended March 31, 2021 and 2020 and the consolidated statements of cash flows for the three months ended March 31, 2021 and 2020 are unaudited, but include all adjustments (consisting of normal recurring adjustments) that the Company considers necessary for a fair presentation of the financial position, operating results, comprehensive loss, changes in stockholders’ equity (deficit) and cash flows, respectively, for the periods presented. Although the Company believes that the disclosures in these unaudited consolidated financial statements are adequate to make the information presented not misleading, certain information and footnote information normally included in consolidated financial statements prepared in accordance with U.S. GAAP have been condensed or omitted as permitted under the rules and regulations of the United States Securities and Exchange Commission (“SEC”).
The unaudited consolidated financial statements include the accounts of Novavax, Inc. and its wholly owned subsidiaries, Novavax AB and Novavax CZ. All intercompany accounts and transactions have been eliminated in consolidation.
The accompanying unaudited consolidated financial statements are presented in U.S. dollars. The functional currency of Novavax AB, which is located in Sweden, is the local currency (Swedish Krona), and the functional currency of Novavax CZ, which is located in the Czech Republic, is the local currency (Czech Koruna). The translation of assets and liabilities of these subsidiaries to U.S. dollars is made at the exchange rate in effect at the consolidated balance sheet date, while equity accounts are translated at historical rates. The translation of the statement of operations data is made at the average exchange rate in effect for the period. The translation of operating cash flow data is made at the average exchange rate in effect for the period, and investing and financing cash flow data is translated at the exchange rate in effect at the date of the underlying transaction. Translation gains and losses are recognized as a component of accumulated other comprehensive loss in the accompanying unaudited consolidated balance sheets. Accumulated other comprehensive (loss) income included a foreign currency translation balance of $( 0.4 ) million and $ 7.0 million as of March 31, 2021 and December 31, 2020, respectively.
The accompanying unaudited consolidated financial statements should be read in conjunction with the financial statements and notes thereto included in the Company's Annual Report on Form 10-K for the year ended December 31, 2020. Results for this or any interim period are not necessarily indicative of results for any future interim period or for the entire year. The Company operates in one business segment.
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Use of Estimates
The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenue and expenses during the reporting period. Actual results could differ materially from those estimates.
Cash and Cash Equivalents
Cash and cash equivalents consist of highly liquid investments with maturities of three months or less from the date of purchase. Cash and cash equivalents consist of the following at (in thousands):
March 31,
2021 December 31,
2020
Cash $ 135,729 $ 122,312
Money market funds 233,344 96,116
Government-backed securities 54,250 44,250
Treasury securities 25,022 44,052
Corporate debt securities 1,547,137 246,668
Cash and cash equivalents $ 1,995,482 $ 553,398
Cash equivalents are recorded at cost, which approximate fair value due to their short-term nature.
Marketable Securities
The Company invests in marketable securities that generally consist of debt securities with maturities greater than three months from the date of purchase that include commercial paper, government-backed securities, treasury securities, corporate notes and agency securities. Classification of marketable securities between current and non-current is dependent upon the maturity date at the balance sheet date taking into consideration the Company's ability and intent to hold the investment to maturity.
Interest and dividend income are recorded when earned and included in investment income in the consolidated statements of operations. Premiums and discounts, if any, on marketable securities are amortized or accreted to maturity and included in investment income in the consolidated statements of operations. The specific identification method is used in computing realized gains and losses on the sale of the Company's securities.
The Company classifies its marketable securities with readily determinable fair values as “available-for-sale.” Investments in securities that are classified as available-for-sale are measured at fair market value in the consolidated balance sheets, and unrealized gains and losses on marketable securities are reported as a separate component of stockholders' equity (deficit) until realized. Marketable securities are evaluated periodically to determine whether a decline in value is “other-than-temporary.” The term “other-than-temporary” is not intended to indicate a permanent decline in value. Rather, it means that the prospects for a near term recovery of value are not necessarily favorable, or that there is a lack of evidence to support fair values equal to, or greater than, the carrying value of the security. Management reviews criteria, such as the magnitude and duration of the decline, as well as the Company's ability to hold the securities, including whether the Company will be required to sell a security prior to recovery of its amortized cost basis, the investment issuer's financial condition and business outlook to predict whether the loss in value is other-than-temporary. Realized gains and losses and declines in value determined to be other-than-temporary are recorded as other income (expense) in the consolidated statements of operations.
Restricted Cash
The Company’s current and non-current restricted cash includes payments received under the Coalition for Epidemic Preparedness Innovations (“CEPI”) funding agreements, payments received under the Bill & Melinda Gates Foundation (“BMGF”) grant agreements and cash collateral accounts under letters of credit that serve as security deposits for certain facility leases. The Company will utilize the CEPI and BMGF funds as it incurs expenses for services performed under these agreements.
As of March 31, 2021, the restricted cash balances (both current and non-current) consisted of $ 1.2 million for payments received from BMGF, $ 30.9 million of payments under the CEPI funding agreements and $ 1.5 million of security
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deposits. As of December 31, 2020, the restricted cash balances (both current and non-current) consisted of $ 1.5 million for payments received from BMGF, $ 92.4 million of payments under the CEPI funding agreements and $ 1.5 million of security deposits of security deposits.
The following table provides a reconciliation of cash, cash equivalents and restricted cash reported in the consolidated balance sheets that sum to the total of the same such amounts shown in the statement of cash flows (in thousands):
March 31,
2021 December 31,
2020
Cash and cash equivalents $ 1,995,482 $ 553,398
Restricted cash current 32,128 93,880
Restricted cash non-current 1,460 1,460
Cash, cash equivalents and restricted cash $ 2,029,070 $ 648,738
Income Taxes
The Company accounts for income taxes in accordance with ASC Topic 740, Income Taxes . Under the liability method, deferred income taxes are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis and operating loss carryforwards.
The Company has historically generated significant federal, state and foreign tax net operating losses, which may be subject to limitation in future periods. Management has fully reserved the related deferred tax assets with a valuation allowance in the current reporting period as more likely than not the related benefit will not be realized. The Company is currently subject to examination in all open tax years.
During the three months ended March 31, 2021, the Company recognized $ 3.0 million of income tax expense related to foreign withholding tax on an advance payment of a license fee.
Net Loss per Share
Net loss per share is computed using the weighted average number of shares of common stock outstanding. As of March 31, 2021 and 2020, the Company had outstanding stock options, stock appreciation rights (“SARs”) and unvested restricted stock units (“RSUs”) totaling 6,273,234 and 4,968,953 , respectively.
As of March 31, 2021, the Company’s Notes (see Note 8) would have been convertible into approximately 2,385,800 shares of the Company’s common stock assuming a common stock price of $ 136.20 or higher. These shares, after giving effect to the add back of interest expense and unamortized debt issuance costs on the Notes (see Note 8) and any shares due to the Company upon settlement of its capped call transactions are excluded from the computation, as their effect is antidilutive.
Recent Accounting Pronouncements
Not Yet Adopted
In August 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”), which will simplify the accounting for certain financial instruments with characteristics of liabilities and equity, including certain convertible instruments and contracts in an entity’s own equity. Specifically, the new standard will remove the separation models required for convertible debt with cash conversion features and convertible instruments with beneficial conversion features. It will also remove certain settlement conditions that are currently required for equity contracts to qualify for the derivative scope exception and will simplify the diluted earnings per share calculation for convertible instruments. ASU 2020-06 will be effective January 1, 2022 for the Company and may be applied using a full or modified retrospective approach. Early adoption is permitted, but no earlier than January 1, 2021 for the Company. Management has evaluated the impact of adopting ASU 2020-06 and has determined that it will not have a material impact on the Company’s consolidated financial statements.
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Note 3 – Fair Value Measurements
The following table represents the Company's fair value hierarchy for its financial assets and liabilities (in thousands):
Fair Value at March 31, 2021 Fair Value at December 31, 2020
Assets Level 1 Level 2 Level 3 Level 1 Level 2 Level 3
Money market funds(1) $ 233,344 $ — $ — $ 96,116 $ — $ —
Government-backed securities(1) — 54,250 — — 44,250 —
Treasury securities(2) — 25,022 — — 54,088 —
Corporate debt securities(3) — 1,549,387 — — 373,681 —
Agency securities — — — — 20,600 —
Total cash equivalents and marketable securities $ 233,344 $ 1,628,659 $ — $ 96,116 $ 492,619 $ —
Liabilities
Convertible notes payable $ — $ 533,705 $ — $ — $ 407,238 $ —
(1) Classified as cash and cash equivalents as of March 31, 2021 and December 31, 2020, respectively, on the consolidated balance sheets.
(2) Includes $ 25,022 and $ 44,052 classified as cash and cash equivalents as of March 31, 2021 and December 31, 2020, respectively, on the consolidated balance sheets.
(3) Includes $ 1,547,137 and $ 246,668 classified as cash and cash equivalents as of March 31, 2021 and December 31, 2020, respectively, on the consolidated balance sheets.
Fixed-income investments categorized as Level 2 are valued at the custodian bank by a third-party pricing vendor's valuation models that use verifiable observable market data, e.g., interest rates and yield curves observable at commonly quoted intervals and credit spreads, bids provided by brokers or dealers or quoted prices of securities with similar characteristics. Pricing of the Company's Notes (see Note 8) has been estimated using other observable inputs, including the price of the Company's common stock, implied volatility, interest rates and credit spreads among others.
During the three months ended March 31, 2021 and 2020, the Company did not have any transfers between levels .
Note 4 – Marketable Securities
Marketable securities classified as available-for-sale as of March 31, 2021 and December 31, 2020 were comprised of (in thousands):
March 31, 2021 December 31, 2020
Amortized
Cost Gross
Unrealized
Gains Gross
Unrealized
Losses Fair Value Amortized
Cost Gross
Unrealized
Gains Gross
Unrealized
Losses Fair Value
Treasury securities $ — $ — $ — $ — $ 10,038 $ — $ ( 2 ) $ 10,036
Corporate debt securities 2,250 — — 2,250 127,003 13 ( 3 ) 127,013
Agency securities — — — — 20,599 1 — 20,600
Total marketable securities $ 2,250 $ — $ — $ 2,250 $ 157,640 $ 14 $ ( 5 ) $ 157,649
The primary objective of the Company's investment policy is the preservation of capital; thus, the Company's investment policy limits investments to certain types of instruments with high-grade credit ratings, places restrictions on maturities and concentrations in certain industries and requires the Company to maintain a certain level of liquidity.
Note 5 – Acquisition of Novavax CZ
The results of operations from Novavax CZ, acquired in May 2020, have been included in the consolidated financial statements since the date of acquisition. As a result, the consolidated financial results for the three months ended March 31, 2020 do not reflect Novavax CZ results. During the three months ended March 31, 2021, Novavax CZ did not recognize any revenue, recorded an exchange rate loss on intercompany loans of $ 5.9 million that is included in other expense in the Consolidated Statement of Operations, and a net loss of $ 16.7 million from Novavax CZ operations.
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The supplemental pro forma financial information for the periods set forth below gives effect to the acquisition as if it had occurred as of January 1, 2020. The pro forma financial information is presented for informational purposes only and is not necessarily indicative of the results of operations that would have been achieved had the acquisition been consummated as of that time. The unaudited pro forma financial information combines the historical results of operations of the Company and Novavax CZ for the periods presented below and reflects the application of certain pro forma adjustments (in thousands, except per share amounts):
Three Months Ended
March 31,
2021 2020
Revenue $ 447,229 $ 3,377
Net loss ( 222,719 ) ( 27,625 )
Basic and diluted net loss per share $ ( 3.05 ) $ ( 0.53 )
Pro forma adjustments include the recognition of depreciation expense based on the acquisition date fair value and remaining useful lives of Novavax CZ fixed assets (net of historical depreciation expense) and the elimination of costs related to the acquisition, which are non-recurring in nature.
Note 6 – Goodwill and Other Intangible Assets
Goodwill
The change in the carrying amounts of goodwill for the three months ended March 31, 2021 was as follows (in thousands):
Amount
Balance at December 31, 2020 $ 135,379
Currency translation adjustments ( 4,500 )
Balance at March 31, 2021 $ 130,879
Identifiable Intangible Assets
Purchased intangible assets consisted of the following as of March 31, 2021 and December 31, 2020 (in thousands):
March 31, 2021 December 31, 2020
Gross
Carrying
Amount Accumulated
Amortization Intangible
Assets, Net Gross
Carrying
Amount Accumulated
Amortization Intangible
Assets, Net
Finite-lived intangible assets:
Proprietary adjuvant technology $ 8,545 $ ( 3,275 ) $ 5,270 $ 9,099 $ ( 3,374 ) $ 5,725
Collaboration agreements 3,859 ( 3,859 ) — 4,109 ( 4,109 ) —
Total identifiable intangible assets $ 12,404 $ ( 7,134 ) $ 5,270 $ 13,208 $ ( 7,483 ) $ 5,725
Amortization expense for the three months ended March 31, 2021 and 2020 was $ 0.1 million and $ 0.2 million respectively.
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Estimated amortization expense for existing intangible assets for the remainder of 2021 and for each of the five succeeding years ending December 31 will be as follows (in thousands):
Year Amount
2021 (remainder) $ 320
2022 427
2023 427
2024 427
2025 427
2026 427
Note 7 - Leases
During the three months ended March 31, 2021, the Company determined that a supply agreement with a contract manufacturing organization was an arrangement that contained an embedded lease under ASC Topic 842, Leases (“ASC 842”) as it has the exclusive use of, and control over, a portion of the manufacturing facility and equipment of the supplier during the contractual term of the arrangement. The lease has a term of 12 months or less at the commencement date and lease payments are recognized as an expense on a straight-line basis over the lease term and variable lease payments, which do not depend on an index or rate, as an expense in the period in which the variable lease costs are incurred based on performance or usage in accordance with contractual agreements. During the three months ended March 31, 2021, the Company recognized a short-term lease expense of $ 127.6 million related to its embedded leases, including a new lease that commenced during the first quarter of 2021. During the three months ended March 31, 2020, the Company did no t incur any short-term embedded lease expense.
Note 8 – Long-Term Debt
Convertible Notes
The Company incurred approximately $ 10.0 million of debt issuance costs during the first quarter of 2016 relating to the issuance of $ 325 million aggregate principal amount of convertible senior unsecured notes that will mature on February 1, 2023 (the “Notes”), which were recorded as a reduction to the Notes on the consolidated balance sheet. The $ 10.0 million of debt issuance costs is being amortized and recognized as additional interest expense over the seven years contractual term of the Notes on a straight-line basis, which approximates the effective interest rate method.
Total convertible notes payable consisted of the following at (in thousands):
March 31,
2021 December 31,
2020
Principal amount of Notes $ 325,000 $ 325,000
Unamortized debt issuance costs ( 2,610 ) ( 2,965 )
Total convertible notes payable $ 322,390 $ 322,035
Interest expense incurred in connection with the Notes consisted of the following (in thousands):
Three Months Ended
March 31,
2020 2019
Coupon interest at 3.75 %
$ 3,047 $ 3,047
Amortization of debt issuance costs 356 356
Total interest expense on Notes $ 3,403 $ 3,403
Note 9 – Stockholders' Equity (Deficit)
In January 2021, the Company entered into an At Market Issuance Sales Agreement ("January 2021 Sales Agreement"), which allows it to issue and sell up to $ 500 million in gross proceeds of its common stock. During the first quarter of 2021, the Company sold 1.7 million shares of common stock under the January 2021 Sales Agreement resulting in $ 452.0 million in net proceeds, leaving $ 42.2 million remaining.
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In November 2020, the Company entered into an At Market Issuance Sales Agreement ("November 2020 Sales Agreement"), which allowed it to issue and sell up to $ 500 million in gross proceeds of its common stock. From January 1, 2021 through January 20, 2021, the Company sold 0.9 million shares of common stock resulting in $ 113.0 million in net proceeds, leaving $ 27.2 million remaining under the agreement. The Company terminated the November 2020 Sales Agreement by mutual agreement upon entering into the January 2021 Sales Agreement.
During the first quarter of 2020, the Company sold 21.5 million shares of common stock resulting in $ 185.9 million in net proceeds under its various At Market Issuance Sales Agreement.
Note 10 – Stock-Based Compensation
Stock Options
The 2015 Stock Incentive Plan, as amended (“2015 Plan”), was approved at the Company's annual meeting of stockholders in June 2015. Under the 2015 Plan, equity awards may be granted to officers, directors, employees and consultants of and advisors to the Company and any present or future subsidiary.
The 2015 Plan authorizes the issuance of up to 10.9 million shares of common stock under equity awards granted under the 2015 Plan. All such shares authorized for issuance under the 2015 Plan have been reserved. The 2015 Plan will expire on March 4, 2025.
The Amended and Restated 2005 Stock Incentive Plan (“2005 Plan”) expired in February 2015 and no new awards may be made under such plan, although awards will continue to be outstanding in accordance with their terms.
The 2015 Plan permits and the 2005 Plan permitted the grant of stock options (including incentive stock options), restricted stock, stock appreciation rights and restricted stock units. In addition, under the 2015 Plan, unrestricted stock, stock units and performance awards may be granted. Stock options and stock appreciation rights generally have a maximum term of ten years and may be or were granted with an exercise price that is no less than 100 % of the fair market value of the Company's common stock at the time of grant. Grants of stock options are generally subject to vesting over periods ranging from one to four years .
Stock Options and Stock Appreciation Rights
The following is a summary of stock options and SARs activity under the 2015 Plan and 2005 Plan for the three months ended March 31, 2021:
2015 Plan 2005 Plan
Stock
Options and SARs Weighted-Average
Exercise
Price Stock
Options Weighted-Average
Exercise
Price
Outstanding at January 1, 2021 5,420,463 $ 38.05 214,186 $ 88.11
Granted 32,958 $ 132.14 — $ —
Exercised ( 437,054 ) $ 51.42 ( 35,401 ) $ 106.49
Canceled ( 6,270 ) $ 27.65 — $ —
Outstanding at March 31, 2021 5,010,097 $ 37.52 178,785 $ 84.47
Shares exercisable at March 31, 2021 590,006 $ 72.46 178,785 $ 84.47
Shares available for grant at March 31, 2021 2,381,759
The fair value of stock options granted under the 2015 Plan was estimated at the date of grant using the Black-Scholes option-pricing model with the following assumptions:
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Three Months Ended
March 31,
2021 2020
Weighted average Black-Scholes fair value of stock options granted $ 116.26 $ 5.39
Risk-free interest rate 0.5 %- 0.9 %
0.6 %- 1.5 %
Dividend yield — % — %
Volatility 124.7 %- 140.3 %
133.6 %- 142.6 %
Expected term (in years) 4.1 - 5.3
3.9
The total aggregate intrinsic value and weighted-average remaining contractual term of stock options and SARs outstanding under the 2015 Plan and 2005 Plan as of March 31, 2021 was approximately $ 738 million and 8.4 years, respectively. The total aggregate intrinsic value and weighted-average remaining contractual term of stock options and SARs exercisable under the 2015 Plan and 2005 Plan as of March 31, 2021 was $ 81.6 million and 5.3 years, respectively. The aggregate intrinsic value represents the total intrinsic value (the difference between the Company's closing stock price on the last trading day of the period and the exercise price, multiplied by the number of in-the-money stock options and SARs) that would have been received by the holders had all stock option and SAR holders exercised their stock options and stock appreciation rights on March 31, 2021. This amount is subject to change based on changes to the closing price of the Company's common stock. The aggregate intrinsic value of stock options and vesting of restricted stock awards for the three months ended March 31, 2021 and 2020 was $ 81.5 million and $ 0.2 million, respectively.
Employee Stock Purchase Plan
The Employee Stock Purchase Plan, as amended (the “ESPP”), was approved at the Company's annual meeting of stockholders in June 2013. The ESPP currently authorizes an aggregate of 600,000 shares of common stock to be purchased. The ESPP allows employees to purchase shares of common stock of the Company at each purchase date through payroll deductions of up to a maximum of 15 % of their compensation, at 85 % of the lesser of the market price of the shares at the time of purchase or the market price on the beginning date of an option period (or, if later, the date during the option period when the employee was first eligible to participate). As of March 31, 2021, there were 212,897 shares available for issuance under the ESPP.
The ESPP is considered compensatory for financial reporting purposes. As such, the fair value of ESPP shares was estimated at the date of grant using the Black-Scholes option-pricing model with the following assumptions:
Three Months Ended
March 31,
2021 2020
Range of Black-Scholes fair values of ESPP shares granted $ 128.70 -$ 238.85
$ 2.57 -$ 35.00
Risk-free interest rate 0.1 % 1.5 %- 2.6 %
Dividend yield — % — %
Volatility 120.4 %- 159.4 %
66.6 %- 154.4 %
Expected term (in years) 0.5 - 2.0
0.5 - 2.0
Restricted Stock Units
The following is a summary of restricted stock units activity for the three months ended March 31, 2021:
Number of
Shares Per Share
Weighted-
Average
Fair Value
Outstanding and Unvested at January 1, 2020 1,044,980 $ 72.59
Restricted stock units granted 69,732 $ 181.24
Restricted stock units vested ( 26,097 ) $ 68.44
Restricted stock units forfeited ( 4,263 ) $ 142.88
Outstanding and Unvested at March 31, 2021 1,084,352 $ 79.39
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The Company recorded all stock-based compensation expense in the consolidated statements of operations as follows (in thousands):
Three Months Ended
March 31,
2021 2020
Research and development $ 23,790 $ 1,908
General and administrative 29,270 2,057
Total stock-based compensation expense $ 53,060 $ 3,965
As of March 31, 2021, there was approximately $ 276 million of total unrecognized compensation expense related to unvested stock options, SARs, restricted stock units and the ESPP. The increase in unrecognized compensation expense is primarily due to the significant increase in the Company's common stock price in 2020. This unrecognized non-cash compensation expense is expected to be recognized over a weighted-average period of 1.1 years, and will be allocated between research and development and general and administrative expenses accordingly. This estimate does not include the impact of other possible stock-based awards that may be made during future periods and awards that require approval by the stockholders.
Note 11 – Contingencies
In February 2021, a Novavax stockholder filed a derivative complaint against members of the Company's board of directors and certain senior management in the Delaware Court of Chancery with Novavax as a nominal defendant. The complaint challenges equity awards made in April 2020 and in June 2020 on the ground that they were “spring-loaded,” that is, made at a time when certain board members or members of senior management allegedly possessed undisclosed positive material information concerning the Company. The complaint asserts claims for breach of fiduciary duty, waste, and unjust enrichment. The plaintiff seeks an award of damages to the Company, an order rescinding the 2020 awards or requiring disgorgement, and an award of attorneys’ fees incurred in connection with the litigation. The defendants intend to move to dismiss the complaint in its entirety. The financial impact of the plaintiff's claim is not estimable.
Note 12 – Revenue
Government Contracts and Grants
During the three months ended March 31, 2021, the Company performed research and development under government contracts and grant, license and clinical development agreements. Revenue primarily consisted of funding under U.S. government contracts and the Company's funding arrangement with the CEPI to advance the clinical development and manufacturing of NVX-CoV2373. The Company’s U.S. government contracts comprise an agreement with Advanced Technology International (“ATI”), the Consortium Management Firm acting on behalf of the Medical CBRN Defense Consortium in connection with the partnership formerly known as Operation Warp Speed (“OWS”) and a contract with the U.S. Department of Defense (the “DoD”). The Company’s revenue from CEPI comprises grant and forgivable loan funding. The
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latter is repayable if the proceeds from the sales of NVX-CoV2373 to one or more third parties covers the Company’s costs of manufacturing the vaccine, not including manufacturing costs funded by CEPI.
The Company recorded revenue from its government contracts and grants as follows (in thousands):
Three Months Ended
March 31,
2021 2020
Government contracts
OWS $ 363,560 $ —
DoD 19,144 —
Grants and other
CEPI 61,561 2,258
BMGF
2,628 256
Other 336 863
Total $ 447,229 $ 3,377
Collaboration and License Agreements
In February 2021, the Company finalized an expanded collaboration and license agreement with SK bioscience to manufacture and commercialize NVX-CoV2373 for sale to the government of Korea. Concurrently, SK bioscience finalized an advance purchase agreement with the Korean government to supply 40 million doses of NVX-CoV2373 to the Republic of Korea beginning in 2021. The agreement is in addition to the Company's existing manufacturing arrangement with SK bioscience entered into in August 2020. Under these agreements, SK bioscience has been granted an exclusive license to develop, manufacture and commercialize NVX-CoV2373 in the Republic of Korea. SK bioscience will expand its capacity to manufacture the antigen component of NVX-CoV2373 for use in the final drug product globally, including product distributed by the COVAX Facility. SK bioscience will also purchase a certain quantity of NVX-CoV2373 directly from the Company, subject to approval by relevant regulatory authority, and sufficient doses of Matrix-M adjuvant to manufacture the remainder of the 40 million doses of NVX-CoV2373 it expects to sell to the Korean government. SK bioscience will pay a tiered royalty in the low to middle double-digit range on the sale of NVX-CoV2373.
In February 2021, the Company finalized a collaboration agreement previously announced in August 2020, with Takeda Pharmaceutical Company Limited (“Takeda”) for the exclusive development, manufacturing and commercialization of NVX-CoV2373 in Japan. Under the agreement, the Company will transfer technology and supply the Matrix-M adjuvant to Takeda, who will manufacture the antigen component of NVX-CoV2373. Takeda will receive funding from the Government of Japan’s Ministry of Health, Labour and Welfare to support the technology transfer, establishment of infrastructure and scale-up of manufacturing. The Company will be entitled to receive royalty payments based on the achievement of certain development and commercial milestones, as well as on a portion of net profits from the sale of the vaccine.
Vaccine Supply Agreements
During the first quarter of 2021, the Company entered into various advanced purchase agreements ("APAs"), including an agreement with Her Majesty the Queen in Right of Canada as represented by the Minister of Public Works and Government Services to supply 52 million doses of NVX-CoV2373. The Company will submit an application for regulatory approval in Canada following its first submission for regulatory approval in another priority market and the Canada authority will provide reasonable assistance to the Company with obtaining such regulatory approval. As part of the agreement, Canada will have the option to purchase up to an additional 24 million doses. In February 2021, the Company reached a MOU with the Canadian government to produce NVX-CoV2373 in Canada. The Company plans to produce NVX-CoV2373 at the National Research Council’s Biologics Manufacturing Centre in Montreal once both the vaccine candidate and the facility receive Health Canada approvals.
In February 2021, the Company entered into a Memorandum of Understanding ("MOU") with Gavi, the Vaccine Alliance ("Gavi"), to provide 1.1 billion cumulative doses of NVX-CoV2373 for the COVAX Facility. In April 2021, the Company finalized an APA with Gavi for vaccine supply and global distribution to COVAX Facility (see Note 13).
During the three months ended March 31, 2021, changes in the Company's accounts receivables, unbilled services and deferred revenue balances were as follows (in thousands):
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December 31, 2020 Additions Deductions March 31, 2021
Accounts receivable $ 262,012 $ 948,083 $ ( 1,153,197 ) $ 56,898
Unbilled services — 240,751 ( 195,456 ) 45,295
Deferred revenue 273,228 755,873 ( 206,292 ) 822,809
As of March 31, 2021, the deferred revenue of $ 822.8 million primarily comprised of approximately $ 772 million related to upfront payments under APAs.
The aggregate amount of the transaction price allocated to performance obligations that were unsatisfied (or partially unsatisfied) was $ 5.0 billion as at March 31, 2021. The Company expects to fulfil its unsatisfied performance obligations within 12 months.
Note 13 – Subsequent Events
In May 2021, the Company finalized an APA with Gavi, building upon its MOU previously announced in February 2021. Under the terms of the agreement, 1.1 billion doses of NVX-CoV2373 are to be made available to countries participating in the COVAX Facility, which was established to allocate and distribute vaccines equitably to participating countries and economies. The Company expects to manufacture and distribute 350 million of NVX-CoV2373 to countries participating under the COVAX Facility. Under a separate purchase agreement with Gavi, SIIPL is expected to manufacture and deliver the balance of the 1.1 billion doses of NVX-CoV2373 for low- and middle-income countries participating in the COVAX Facility. The Company expects to deliver doses with antigen and adjuvant manufactured at facilities directly funded under the Company's funding agreement with CEPI. The Company expects to supply significant doses that Gavi would allocate to low, middle and high income countries, subject to certain limitations, utilizing a tiered pricing schedule and Gavi may prioritize such doses to low and middle income countries, at lower prices. Additionally, the Company may provide additional doses, to the extent available from CEPI funded manufacturing facilities, in the event that SIIPL cannot materially deliver expected vaccine doses to the COVAX Facility.Together with SIIPL, the Company expects to initiate delivery of the cumulative 1.1 billion doses in the third quarter of 2021, pending receipt of appropriate regulatory authorizations. Under the agreement, the Company expects to receive an upfront payment from Gavi and an additional payment after securing emergency use listing for NVX-CoV2373 by the World Health Organization. Under the agreement, the Company expects to receive an upfront payment from Gavi and an additional payment after securing emergency use listing for NVX-CoV2373 by the World Health Organization.
In April 2021, the Company's OWS agreement was amended to fully fund the agreement up to $ 1.75 billion to support certain activities related to the development of NVX-CoV2373 and the manufacture and delivery of the vaccine candidate to the U.S. Government. OWS is a partnership among components of the U.S. Department of Health and Human Services and the U.S. Department of Defense working to accelerate the development, manufacturing and distribution of COVID-19 vaccines, therapeutics, and diagnostics.
In April 2021, the Company announced the pre-print publication of data from a Phase 2b clinical trial in children demonstrating up to 77 % efficacy for a malaria vaccine candidate, R21, created by the University of Oxford that includes the Company's Matrix-M adjuvant and is licensed to SIIPL. The Company will manufacture and supply the Matrix-M component of R21 to SIIPL. Additionally, SIIPL has the rights to use Matrix-M in the vaccine in regions where the disease is endemic and will pay royalties to the Company on its market sales of the vaccine. The Company will have commercial rights to sell and distribute the SIIPL-manufactured vaccine in certain countries, primarily in the travelers’ and military vaccine markets.
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.