What changed in this filing

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Item 1. Financial Statements

2023-08-08 compared with 2023-05-09 · 248 added, 161 removed, 429 unchanged (49% of the section changed)

4 unchanged sentences

For the Three Months Ended

June 30, For the Six Months Ended

2023 2022 2023 2022

Product sales $ 285,163 $ 55,455 $ 277,706 $ 641,083

9 unchanged sentences

Interest expense ( 3,124 ) ( 6,234 ) ( 7,440 ) ( 11,110 )

Other income 24,362 1,654

Income (Loss) before income tax expense ( 292,722 ) 206,070

Income tax expense 1,183 2,662

Other income (expense) 5,532 ( 19,873 ) 29,894 ( 18,219 )

Income (Loss) before income tax expense (benefit) 57,865 ( 509,067 ) ( 234,857 ) ( 302,997 )

Income tax expense (benefit) ( 143 ) 1,418 1,040 4,080

Net income (loss) $ 58,008 $ ( 510,485 ) $ ( 235,897 ) $ ( 307,077 )

8 unchanged sentences

For the Three Months Ended

June 30, For the Six Months Ended

2023 2022 2023 2022

Net income (loss) $ 58,008 $ ( 510,485 ) $ ( 235,897 ) $ ( 307,077 )

Other comprehensive income:

Other comprehensive income (loss):

Foreign currency translation adjustment ( 5,011 ) ( 9,558 ) ( 1,800 ) ( 9,517 )

Other comprehensive income 3,211 41

Other comprehensive income (loss) ( 5,011 ) ( 9,558 ) ( 1,800 ) ( 9,517 )

Comprehensive income (loss) $ 52,997 $ ( 520,043 ) $ ( 237,697 ) $ ( 316,594 )

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Commitments and contingencies (Note 15)

Preferred stock, $ 0.01 par value, 2,000,000 shares authorized at March 31, 2023 and December 31, 2022;

no shares issued and outstanding at March 31, 2023 and December 31, 2022.

Preferred stock, $ 0.01 par value, 2,000,000 shares authorized at June 30, 2023 and December 31, 2022;

no shares issued and outstanding at June 30, 2023 and December 31, 2022.

Stockholders' deficit:

Common stock, $ 0.01 par value, 600,000,000 shares authorized at March 31, 2023 and December 31, 2022;

87,139,831 shares issued and 86,291,473 shares outstanding at March 31, 2023 and 86,806,554 shares issued and 86,039,923 shares outstanding at December 31, 2022

Common stock, $ 0.01 par value, 600,000,000 shares authorized at June 30, 2023 and December 31, 2022;

95,183,750 shares issued and 94,308,379 shares outstanding at June 30, 2023 and 86,806,554 shares issued and 86,039,923 shares outstanding at December 31, 2022

Additional paid-in capital 3,855,916 3,737,979

Accumulated deficit ( 4,511,786 ) ( 4,275,889 )

Treasury stock, cost basis, 848,358 shares at March 31, 2023 and 766,631 shares at December 31, 2022

Treasury stock, cost basis, 875,371 shares at June 30, 2023 and 766,631 shares at December 31, 2022

( 91,424 ) ( 90,659 )

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CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (DEFICIT)

Three Months Ended March 31, 2023 and 2022

Three and Six Ended June 30, 2023 and 2022

(in thousands, except share information)

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Shares Amount

Balance at March 31, 2023 87,139,831 $ 871 $ 3,767,733 $ ( 4,569,794 ) $ ( 91,226 ) $ ( 3,166 ) $ ( 895,582 )

Stock-based compensation — — 20,292 — — — 20,292

Stock issued under incentive programs 95,965 1 ( 1 ) — ( 198 ) — ( 198 )

Issuance of common stock, net of issuance costs $ 861

7,947,954 80 67,892 — — — 67,972

Foreign currency translation adjustment — — — — — ( 5,011 ) ( 5,011 )

Net income — — — 58,008 — — 58,008

Balance at June 30, 2023 95,183,750 $ 952 $ 3,855,916 $ ( 4,511,786 ) $ ( 91,424 ) $ ( 8,177 ) $ ( 754,519 )

Balance at March 31, 2022 78,722,337 $ 787 $ 3,566,292 $ ( 3,414,542 ) $ ( 85,901 ) $ ( 1,312 ) $ 65,324

Stock-based compensation — — 38,048 — — — 38,048

Stock issued under incentive programs 53,897 1 274 — ( 554 ) — ( 279 )

Foreign currency translation adjustment — — — — — ( 9,558 ) ( 9,558 )

Net loss — — — ( 510,485 ) — — ( 510,485 )

Balance at June 30, 2022 78,776,234 $ 788 $ 3,604,614 $ ( 3,925,027 ) $ ( 86,455 ) $ ( 10,870 ) $ ( 416,950 )

Common Stock Additional

Capital Accumulated

Deficit Treasury

Stock Accumulated Other

Comprehensive

Loss Total Stockholders'

Equity (Deficit)

Shares Amount

Balance at December 31, 2022 86,806,554 $ 868 $ 3,737,979 $ ( 4,275,889 ) $ ( 90,659 ) $ ( 6,377 ) $ ( 634,078 )

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Stock issued under incentive programs 429,242 4 1,106 — ( 765 ) — 345

Issuance of common stock, net of issuance costs of $ 861

7,947,954 80 67,892 — — — 67,972

Foreign currency translation adjustment — — — — — ( 1,800 ) ( 1,800 )

Net loss — — — ( 235,897 ) — — ( 235,897 )

Balance at March 31, 2023 87,139,831 $ 871 $ 3,767,733 $ ( 4,569,794 ) $ ( 91,226 ) $ ( 3,166 ) $ ( 895,582 )

Balance at June 30, 2023 95,183,750 $ 952 $ 3,855,916 $ ( 4,511,786 ) $ ( 91,424 ) $ ( 8,177 ) $ ( 754,519 )

Balance at December 31, 2021 76,433,151 $ 764 $ 3,351,967 $ ( 3,617,950 ) $ ( 85,101 ) $ ( 1,353 ) $ ( 351,673 )

4 unchanged sentences

Foreign currency translation adjustment — — — — — ( 9,517 ) ( 9,517 )

Net income — — — 203,408 — — 203,408

Balance at March 31, 2022 78,722,337 $ 787 $ 3,566,292 $ ( 3,414,542 ) $ ( 85,901 ) $ ( 1,312 ) $ 65,324

Net loss — — — ( 307,077 ) — — ( 307,077 )

Balance at June 30, 2022 78,776,234 $ 788 $ 3,604,614 $ ( 3,925,027 ) $ ( 86,455 ) $ ( 10,870 ) $ ( 416,950 )

The accompanying notes are an integral part of these financial statements.

2 unchanged sentences

(in thousands)

Three Months Ended March 31,

Six Months Ended June 30,

Operating Activities:

Net income (loss) $ ( 293,905 ) $ 203,408

Reconciliation of net income (loss) to net cash provided by (used in) operating activities:

Net loss $ ( 235,897 ) $ ( 307,077 )

Reconciliation of net loss to net cash used in operating activities:

Depreciation and amortization 19,110 13,485

1 unchanged sentence

Provision for excess and obsolete inventory 31,546 155,662

Impairment of long-lived assets 10,081 —

Right-of-use assets expensed, net of credits received — ( 3,291 )

18 unchanged sentences

Effect of exchange rate on cash, cash equivalents, and restricted cash ( 8,992 ) ( 4,453 )

Net increase (decrease) in cash, cash equivalents, and restricted cash ( 711,902 ) 55,841

Net decrease in cash, cash equivalents, and restricted cash ( 830,904 ) ( 140,744 )

Cash, cash equivalents, and restricted cash at beginning of period 1,348,845 1,528,259

1 unchanged sentence

Supplemental disclosure of non-cash activities:

Sales of common stock not settled at end of period $ 5,986 $ —

Right-of-use assets from new lease agreements $ — $ 69,366

6 unchanged sentences

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

March 31, 2023

June 30, 2023

Note 1 – Organization and Business

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(“Novavax,” and together with its wholly owned subsidiaries, the “Company”) is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.

The Company’s COVID-19 vaccine (“NVX-CoV2373,” “Nuvaxovid™,” “Covovax™,” “Novavax COVID-19 Vaccine, Adjuvanted”);

influenza vaccine candidate;

COVID-19-Influenza Combination (“CIC”) vaccine candidate;

and additional vaccine candidates, including for Omicron subvariants and bivalent formulations with prototype vaccine (“NVX-CoV2373”), are genetically engineered nanostructures of conformationally correct recombinant proteins critical to disease pathogenesis and may elicit differentiated immune responses, which may be more efficacious than naturally occurring immunity or other vaccine approaches.

NVX-CoV2373 and the Company’s other vaccine candidates incorporate the Company's proprietary Matrix-M™ adjuvant to enhance the immune response and stimulate higher levels of functional antibodies and induce a cellular immune response.

The Company has announced data from its ongoing PREVENT-19 study supporting the use of NVX-CoV2373 for homologous boosting in adults and adolescents aged 12 through 17.

Additional findings in Phase 3 COVID-19 Omicron (study 311) trial showed utility of the prototype vaccine as a heterologous booster, inducing broad immune responses against contemporary Omicron variants.

The Company has received approval, interim authorization, provisional approval, conditional marketing authorization, and emergency use authorization (“EUA”) from multiple regulatory authorities globally for NVX-CoV2373 for both adult and adolescent populations as a primary series and for both homologous and heterologous booster indications, and commenced commercial shipments of NVX-CoV2373 doses under the name “Novavax COVID-19 Vaccine, Adjuvanted” and the brand name “Nuvaxovid™” during the first quarter 2022.

The Company’s vaccines and vaccine candidates are genetically engineered nanostructures of conformationally correct recombinant proteins critical to disease pathogenesis and may elicit differentiated immune responses, which may be more efficacious than naturally occurring immunity or other vaccine approaches.

Novavax currently has one commercial program, for vaccines to prevent COVID (“Novavax COVID Vaccine, Adjuvanted”), which it markets in various territories where it is allowed to do so, under the brand name “Nuvaxovid™”.

Novavax’s prototype COVID vaccine was derived from the prototype strain of COVID and is variously referred to here and in prior financial statements without branding as “NVX-CoV2373”.

Our partners, Serum Institute of India Pvt.

(“SIIPL”) markets NVX-CoV2373 as “Covovax™.” Novavax is currently developing an updated vaccine which it refers to as its “XBB COVID vaccine.”

Beginning in 2022, the Company received approval, interim authorization, provisional approval, conditional marketing authorization, and emergency use authorization (“EUA”) from multiple regulatory authorities globally for NVX-CoV2373 for both adult and adolescent populations as a primary series and for both homologous and heterologous booster indications.

Novavax is currently seeking similar approvals from multiple regulatory authorities globally for its XBB COVID vaccine as a single dose booster for the fall 2023 and subsequently.

The Company exclusively depends on its supply agreement with SIIPL and its subsidiary, Serum Life Sciences Limited (“SLS”), for co-formulation, filling and finishing (other than in Europe) and on its service agreement with PCI Pharma Services (“PCI”) for finishing in Europe.

The Company plans to rely on these arrangements to supply the XBB COVID vaccine, if authorized, during the 2023 fall vaccination campaign and subsequently (see Note 4).

Novavax is advancing development of other vaccine candidates, including its influenza vaccine candidate, its COVID-Influenza Combination (“CIC”) vaccine candidate and additional vaccine candidates.

Novavax COVID Vaccine, Adjuvanted and its other vaccine candidates incorporate the Company’s proprietary Matrix-M™ adjuvant to enhance the immune response and stimulate higher levels of functional antibodies and induce a cellular immune response.

Note 2 – Summary of Significant Accounting Policies

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All intercompany accounts and transactions have been eliminated in consolidation.

Accumulated other comprehensive loss included a foreign currency translation loss of $ 3.2 million and $ 6.4 million at March 31, 2023 and December 31, 2022, respectively.

The aggregate foreign currency transaction gains resulting from the conversion of the transaction currency to functional currency were $ 16.3 million and $ 2.2 million for the three months ended March 31, 2023 and 2022, respectively, which are reflected in Other income.

Accumulated other comprehensive loss included a foreign currency translation loss of $ 8.2 million and $ 6.4 million at June 30, 2023 and December 31, 2022, respectively.

The aggregate foreign currency transaction gains and losses resulting from the conversion of the transaction currency to functional currency were a $ 0.2 million loss and a $ 16.1 million gain, and a $ 22.2 million and $ 21.0 million loss for the three months and six months ended June 30, 2023 and 2022, respectively, which are reflected in Other income (expense).

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, 2022.

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The accompanying unaudited consolidated financial statements have been prepared assuming that the Company will continue as a going concern within one year after the date that the financial statements are issued.

At March 31, 2023, the Company had $ 636.9 million in cash and cash equivalents and restricted cash.

In April 2023, the Company repaid $ 112.5 million related to the refund due under the Amended and Restated SARS-CoV-2 Vaccine Supply Agreement, dated July 1, 2022, as further amended on September 26, 2022, (the “Amended and Restated UK Supply Agreement”) with The Secretary of

State for Business, Energy and Industrial Strategy (as assigned to the UK Health Security Agency), acting on behalf of the government of the United Kingdom of Great Britain and Northern Ireland, which amended and restated in its entirety the SARS-CoV-2 Vaccine Supply Agreement, dated October 22, 2020, between the parties, and $ 27.0 million related to a Settlement Agreement and Release of Claims between the Company and Par Sterile Products, LLC (“Par”), as described in Note 15 below, which was fully accrued as of March 31, 2023.

During the three months ended March 31, 2023, the Company incurred a net loss of $ 293.9 million and had net cash flows used in operating activities of $ 325.6 million.

In addition, as of June 30, 2023, the Company had $ 517.9 million in cash and cash equivalents and restricted cash.

Pursuant to the June 2023 Amendment to the advance purchase agreement (“APA”) between the Company and His Majesty the King in Right of Canada, as represented by the Minister of Public Works and Government Services, as successor in interest to Her Majesty the Queen in Right of Canada, as represented by the Minister of Public Works and Government Services (“Canadian government”), the Company received $ 174.8 million from the Canadian government in July 2023 with a second installment of $ 174.8 million that is contingent and payable upon the Company’s delivery of vaccine doses in the second half of 2023 (see Note 3).

During the six months ended June 30, 2023, the Company incurred a net loss of $ 235.9 million and had net cash flows used in operating activities of $ 497.5 million.

In accordance with Accounting Standards Codification 205-40, Going Concern, the Company evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about its ability to continue as a going concern within one year after the date that these unaudited consolidated financial statements are issued.

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government, and a pending matter subject to arbitration proceedings.

The Company’s revenue projections depend on its ability to successfully develop, manufacture, distribute, and market an updated monovalent or bivalent formulation of a vaccine candidate for COVID-19 for the Fall 2023 COVID vaccine season, which is inherently uncertain and subject to a number of risks, including regulatory approval and commercial adoption.

The Company’s revenue projections depend on its ability to successfully develop, manufacture, distribute and market an updated monovalent formulation of a vaccine candidate for COVID-19 for the fall 2023 COVID vaccine season, which is inherently uncertain and subject to a number of risks, including regulatory authorization, ability to timely deliver doses and commercial adoption and market acceptance.

Further, failure to meet regulatory milestones, timely obtain supportive recommendations from governmental advisory committees, or achieve product volume or delivery timing obligations under the Company’s advance purchase agreements may require the Company to refund portions of upfront and other payments or result in reduced future payments.

For example, if the Company fails to deliver XBB COVID vaccine doses to the Canadian government in the second half of 2023, the second installment payment of $ 174.8 million will be terminated and not be payable to the Company.

Also, if the Company does not timely achieve supportive recommendations from the Joint Committee on Vaccination and Immunisation (the “JCVI”) of the government of the United Kingdom of Great Britain and Northern Ireland with respect to use of NVX-CoV2373 for (a) the general adult population as part of a SARS-CoV-2 vaccine booster campaign in the United Kingdom or (b) the general adolescent population as part of a SARS-CoV-2 vaccine booster campaign in the United Kingdom or as a primary series SARS-CoV-2 vaccination, excluding where that recommendation relates only to one or more population groups comprising less than one million members in the United Kingdom, then the Company would be required to repay up to $ 112.5 million related to the upfront payment previously received from the Authority under the Original UK Supply Agreement.

In February 2023, in connection with the execution of Modification 17 to the USG Agreement (as defined in Note 3), the U.S.

government indicated to the Company that the award may not be extended past its current period of performance.

If the USG Agreement is not amended, as the Company’s management had previously expected, then the Company may not receive all of the remaining $ 336.4 million in funding that was previously anticipated pursuant to the USG Agreement.

If the USG Agreement is not amended, as the Company’s management had previously expected, then the Company may not receive all of the remaining $ 250.6 million in funding as of June 30, 2023.

On January 24, 2023, Gavi, the Vaccine Alliance (“Gavi”) filed a demand for arbitration with the International Court of Arbitration regarding an alleged material breach by the Company of the Company’s advance purchase agreement with Gavi (the “Gavi APA”).

The outcome of that arbitration is inherently uncertain, and it is possible the Company could be required to refund all or a portion of the remaining advance payments of $ 697.4 million (see Note 3 and Note 15).

The arbitration hearing is scheduled for July 2024, with a written decision to follow.

The outcome of that arbitration is inherently uncertain, and it is possible the Company could be required to refund all or a portion of the remaining advance payments of $ 696.4 million as of June 30, 2023 (see Note 3 and Note 15).

Management believes that, given the significance of these uncertainties, substantial doubt exists regarding the Company’s ability to continue as a going concern through one year from the date that these financial statements are issued.

In May 2023, the Company announced a global restructuring and cost reduction plan.

This plan includes a more focused investment in its NVX-CoV2373 program, reduction to its pipeline spending, the continued rationalization of its manufacturing network, a reduction to the Company’s global workforce, as well as the consolidation of facilities and infrastructure.

The planned workforce reduction includes an approximately 25 % reduction in the Company’s global workforce, comprised of an approximately 20 % reduction in full-time Novavax employees and the remainder comprised of contractors and consultants.

The Company expects the full annual impact of the cost savings to be realized in 2024 and approximately half of the annual impact to be realized in 2023 due to timing of implementing the measures, and the applicable laws, regulations, and other factors in the jurisdictions in which the Company operates.

The Company expects to record a charge of approximately $ 10 million to $ 15 million related to one-time employee severance and benefit costs, the majority of which are expected to be incurred in the second quarter of 2023 and is evaluating the anticipated costs related to the consolidation of facilities and infrastructure.

the resolution of certain matters, including whether, when, and how the dispute with Gavi is resolved;

and management’s plans, which include resolving the dispute with Gavi and cost reductions associated with the Company’s global restructuring and cost reduction plan.

In May 2023, the Company announced a global restructuring and cost reduction plan (the “Restructuring Plan”) which includes a more focused investment in its NVX-CoV2373 program, reduction to its pipeline spending, the continued rationalization of its manufacturing network, a reduction to the Company’s global workforce, as well as the consolidation of facilities, and infrastructure.

The workforce reduction plan included an approximately 25 % reduction in the Company’s global workforce, comprised of an approximately 20 % reduction in full-time Novavax employees and the remainder comprised of contractors and consultants.

The Company has decided to progress CIC toward late-stage development and, as such, is assessing the impact on its workforce requirements.

The Company expects the full annual impact of the cost savings from the Restructuring Plan to be realized in 2024 and approximately half of the annual impact to be realized in 2023 due to timing of implementing the measures, and the applicable laws, regulations, and other factors in the jurisdictions in which the Company operates.

During the three months ended June 30, 2023, the Company recorded a charge of $ 4.6 million related to one-time employee severance and benefit costs and $ 10.1 million related to the consolidation of facilities and infrastructure (see Note 16).

The Company’s ability to fund Company operations is dependent upon revenue related to vaccine sales for its products and product candidates, if such product candidates receive marketing approval and are successfully commercialized, and in particular the 2023 fall COVID vaccination campaign, which is inherently uncertain and subject to a number of risks, including regulatory authorization, ability to timely deliver doses and commercial adoption and market acceptance, the resolution of certain matters, including whether, when, and how the dispute with Gavi is resolved, and management’s plans, which includes cost reductions associated with the Restructuring Plan.

Management’s plans may also include raising additional capital through a combination of equity and debt financing, collaborations, strategic alliances, and marketing, distribution, or licensing arrangements.

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Also, any collaborations, strategic alliances, and marketing, distribution, or licensing arrangements may require the Company to give up some or all of its rights to a product or technology, which in some cases may be at less than the full potential value of such rights.

In addition, the regulatory and commercial success of NVX-CoV2373 and the Company’s other vaccine candidates, including an influenza vaccine candidate, a CIC vaccine candidate, and a COVID-19 variant strain-containing monovalent or bivalent formulation, remains uncertain.

If the Company is unable to obtain additional capital, the Company will assess its capital resources and may be required to delay, reduce the scope of, or eliminate some or all of its operations, or further downsize its organization, any of which may have a material adverse effect on its business, financial condition, results of operations, and ability to operate as a going concern.

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Specifically, if a customer arrangement includes a provision whereby the customer may request a discount, return, or refund for a previously satisfied performance obligation or otherwise could have the effect of decreasing the transaction price, revenue is constrained based on an estimate of the impact to the transaction price recognized until it is probable that a significant reversal in cumulative revenue recognized will not occur.

Restructuring

The Company recognizes restructuring charges when such costs are incurred.

The Company's restructuring charges consist of employee severance and other termination benefits related to the reduction of its workforce, the consolidation of facilities, and infrastructure and other costs.

Termination benefits are expensed on the date the Company notifies the employee, unless the employee must provide future service, in which case the benefits are expensed ratably over the future service period.

Ongoing benefits are expensed when restructuring activities are probable and the benefit estimable.

See Note 16 for additional information on the severance and employee benefit costs for terminated employees and impairment of assets in connection with the Company’s Restructuring Plan.

Recent Accounting Pronouncements

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Note 3 – Revenue

The Company's accounts receivable included $ 70.2 million, $ 53.8 million, $ 425.9 million, and $ 419.7 million related to amounts that were billed to customers and $ 42.7 million, $ 28.6 million, $ 52.3 million, and $ 35.3 million related to amounts which had not yet been billed to customers as of March 31, 2023, December 31, 2022, March 31, 2022, and December 31, 2021, respectively.

During the three months ended March 31, 2023 and 2022, changes in the Company's accounts receivables, allowance for doubtful accounts, and deferred revenue balances were as follows (in thousands):

The Company's accounts receivable included $ 334.4 million and $ 53.8 million related to amounts that were billed to

customers and $ 60.5 million and $ 28.6 million related to amounts which had not yet been billed to customers as of June 30, 2023 and December 31, 2022, respectively.

During the six months ended June 30, 2023, and 2022, changes in the Company's accounts receivables, allowance for doubtful accounts, and deferred revenue balances were as follows (in thousands):

Balance, Beginning of Period Additions Deductions Balance, End of Period

Accounts receivable:

Three months ended March 31, 2023 $ 96,210 $ 146,424 $ ( 115,950 ) $ 126,684

Three months ended March 31, 2022 454,993 625,124 ( 601,961 ) 478,156

Six Months Ended June 30, 2023 $ 96,210 $ 793,039 $ ( 486,684 ) $ 402,565

Six Months Ended June 30, 2022 454,993 808,713 ( 1,069,173 ) 194,533

Allowance for doubtful accounts (1) :

Three months ended March 31, 2023 $ ( 13,835 ) $ — $ — $ ( 13,835 )

Three months ended March 31, 2022 — — — —

Six Months Ended June 30, 2023 $ ( 13,835 ) $ — $ 6,160 $ ( 7,675 )

Six Months Ended June 30, 2022 — — — —

Deferred revenue:

Three months ended March 31, 2023 $ 549,551 $ 140,324 $ ( 49 ) $ 689,826

Three months ended March 31, 2022 1,595,472 49,094 ( 108,586 ) 1,535,980

(1) There was no bad debt expense recorded during the three months ended March 31, 2023 or 2022.

Six Months Ended June 30, 2023 $ 549,551 $ 414,816 $ ( 56,957 ) $ 907,410

Six Months Ended June 30, 2022 1,595,472 49,107 ( 128,432 ) 1,516,147

(1) There was no bad debt expense recorded during the three and six months ended June 30, 2023 or 2022.

There was a $ 6.2 million reversal of a bad debt allowance during the three months ended June 30, 2023 due to the collection of a previously recognized allowance for doubtful accounts.

To estimate the allowance for doubtful accounts, the Company evaluates the credit risk related to its customers based on historical loss experience, economic conditions, the aging of receivables, and customer-specific risks.

As of March 31, 2023, the aggregate amount of the transaction price allocated to performance obligations that were unsatisfied (or partially unsatisfied), excluding amounts related to sales-based royalties, the Gavi APA, and the reduction in doses related to the Amended and Restated UK Supply Agreement, was approximately $ 3 billion of which $ 689.8 million was included in Deferred revenue.

Failure to meet regulatory milestones, timely obtain supportive recommendations from governmental advisory committees, or achieve product volume or delivery timing obligations under the Company’s advance purchase agreements (“APAs”) may require the Company to refund portions of upfront payments or result in reduced future payments, which could adversely impact the Company’s ability to realize revenue from its unsatisfied performance obligations.

(2) Deductions from Deferred revenue generally related to the recognition of revenue once performance obligations on a contract with a customer are met.

As of June 30, 2023, the aggregate amount of the transaction price allocated to performance obligations that were unsatisfied (or partially unsatisfied), excluding amounts related to sales-based royalties, the Gavi APA, and the reduction in doses related to the Amended and Restated UK Supply Agreement, was approximately $ 2 billion of which $ 907.4 million was included in Deferred revenue.

Failure to meet regulatory milestones, timely obtain supportive recommendations from governmental advisory committees, or achieve product volume or delivery timing obligations under the Company’s advance purchase agreements may require the Company to refund portions of upfront and other payments or result in reduced future payments, which could adversely impact the Company’s ability to realize revenue from its unsatisfied performance obligations.

The timing to fulfill performance obligations related to grant agreements will depend on the results of the Company's research and development activities, including clinical trials, and delivery of doses.

The timing to fulfill performance obligations related to APAs will depend on timing of product manufacturing, receipt of marketing authorizations for additional indications, delivery of doses based on customer demand, and the ability of the customer to request variant vaccine in place of the prototype

NVX-CoV2373 vaccine under certain of our APAs.

The remaining unfilled performance obligations not related to grant agreements or APAs are expected to be fulfilled in less than 12 months.

Under the terms of the Gavi APA and a separate purchase agreement between Gavi and Serum Institute of India Pvt.

(“SIIPL”), 1.1 billion doses of NVX-CoV2373 were to be made available to countries participating in the COVAX Facility.

The timing to fulfill performance obligations related to APAs will depend on the timing of product manufacturing, receipt of marketing authorizations for additional indications, delivery of doses based on customer demand, and the ability of the customer to request variant vaccine in place of the prototype NVX-CoV2373 vaccine under certain of the Company’s APAs.

Under the terms of the Gavi APA and a separate purchase agreement between Gavi and SIIPL, 1.1 billion doses of NVX-CoV2373 were to be made available to countries participating in the COVAX Facility.

The Company expected to manufacture and distribute 350 million doses of NVX-CoV2373 to countries participating under the COVAX Facility.

Under a separate purchase agreement with Gavi, SIIPL was 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 expected to deliver doses with antigen and adjuvant manufactured at facilities directly funded under the Company's funding agreement with Coalition for Epidemic Preparedness Innovations (“CEPI”), with initial doses supplied by SIIPL and Serum Life Sciences Limited (“SLS”) under a supply agreement.

The Company expected 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 could prioritize such doses to low- and middle- income countries, at lower prices.

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As of November 18, 2022, the Company had only received orders under the Gavi APA for approximately 2 million doses.

On December 2, 2022, Gavi issued a written notice purporting to terminate the Gavi APA based on Gavi’s contention that the Company repudiated the agreement and, therefore, materially breached the Gavi APA.

December 2, 2022, Gavi issued a written notice purporting to terminate the Gavi APA based on Gavi’s contention that the Company repudiated the agreement and, therefore, materially breached the Gavi APA.

Gavi also contends that, based on its purported termination of the Gavi APA, it is entitled to a refund of the Advance Payment Amount less any amounts that have been credited against the purchase price for binding orders placed by a buyer participating in the COVAX Facility.

As of March 31, 2023, the remaining Gavi Advance Payment Amount of $ 697.4 million, pending resolution of the dispute with Gavi related to a return of the remaining Advance Payment Amount, was reclassified from Deferred revenue to Other current liabilities in the Company’s consolidated balance sheets.

Since December 31, 2022, the remaining Gavi Advance Payment Amount, which is $ 696.4 million as of June 30, 2023, pending resolution of the dispute with Gavi related to a return of the remaining Advance Payment Amount, has been classified within Other current liabilities in the Company’s consolidated balance sheet.

On January 24, 2023, Gavi filed a demand for arbitration with the International Court of Arbitration based on the claims described above.

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On April 5, 2023, Gavi filed its Reply to the Company’s Counterclaims.

The arbitration hearing is scheduled for July 2024, with a written decision to follow.

Arbitration is inherently uncertain, and while the Company believes that it is entitled to retain the remaining Advance Payment Amount received from Gavi, it is possible that it could be required to refund all or a portion of the remaining Advance Payment Amount from Gavi.

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Three Months Ended

June 30, Six Months Ended

2023 2022 2023 2022

North America

$ — $ — $ — $ 64,762

Europe 1,518 — 58,785 413,745

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283,645 55,455 218,921 162,576

Total product revenue $ ( 7,457 ) $ 585,628

In May 2023, the Company extended a credit for certain doses delivered in 2022 that qualified for replacement under the contract with the customer.

This credit is the result of a single lot sold to the Australian government that upon pre-planned 6-month stability testing was found to have fallen below the defined specifications and the lot was therefore removed from the market.

The credit will be applied against the future sale of doses to the customer and, during the three months ended March 31, 2023, the Company recorded a reduction of $ 64.7 million in product sales, with a corresponding increase to Deferred revenue, non-current.

Total product sales revenue $ 285,163 $ 55,455 $ 277,706 $ 641,083

In May 2023, the Company extended a credit for certain doses delivered in 2022 that qualified for replacement under the contract with the Australian government.

The credit will be applied against the future sale of doses to the customer and, during the six months ended June 30, 2023, the Company recorded a reduction of $ 64.7 million in product sales, with a corresponding increase to Deferred revenue, non-current.

In April 2023, the Company amended its APA with the Canadian government, for the purchase of doses of NVX-CoV2373 (the “Canada APA”) to forfeit certain doses originally scheduled for delivery in 2022 for a payment of $ 100.4 million received in the second quarter of 2023.

On June 30, 2023, the Company entered into an additional amendment (the “June 2023 Amendment”) to the Canada APA.

Pursuant to the June 2023 Amendment, the parties revised the Canadian government’s previous commitment by (i) forfeiting certain doses of the NVX-CoV2373 previously scheduled for delivery, (ii) reducing the amount of doses of NVX-CoV2373 due for delivery, (iii) revising the delivery schedule for the remaining doses of NVX-CoV2373 to be delivered, and (iv) requiring use of the Biologics Manufacturing Centre (“BMC”) Inc.

to produce bulk antigen for doses in 2024 and 2025.

In connection with the forfeiture of doses of NVX-CoV2373, the Canadian government agreed to pay a total amount of $ 349.6 million to the Company in two equal installments in 2023, which total amount equals the remaining balance owed by the Canadian government with respect to such forfeited vaccine doses.

The first installment was payable upon execution of the June 2023 Amendment and the second installment is contingent and payable upon the Company’s delivery of vaccine doses in the second half of 2023.

The first installment of $ 174.8 million was received from the Canadian government in July 2023.

If the Company fails to deliver COVID-19 vaccine doses to the Canadian government in the second half of 2023, the second installment payment of $ 174.8 million will be terminated and not be payable to the Company.

The Canadian Government may terminate the Canada APA, as amended, if the Company fails to achieve regulatory approval for use of BMC for NVX-CoV2373 production on or before December 31, 2024.

The June 2023 Amendment maintained the total contract value of the original Canada APA.

Pursuant to the June 2023 Amendment, the Company and the Canadian government will endeavor to expand the Company’s previously agreed in-country commitment to Canada and to further partner to provide health, economic, and future pandemic preparedness benefits to Canada, which value may be provided through a number of activities, including without limitation, capital investments, the performance of activities or services, or the provision of technology or intellectual property licenses.

Further, the parties will endeavor to enter into a memorandum of understanding (the “MOU”) to illustrate the Company’s ability to deliver such benefits over a 15 year period with an aggregate value of not less than 100 % of the amount remaining to be paid under the June 2023 Amendment and ultimately received by the Company.

The Company agreed to hold $ 20 million in escrow for the benefit of the Canadian

government, which amount is the sole recourse available to the Canadian government in the event of non-performance under the MOU.

The Company’s U.S.

government agreement consists of a Project Agreement (the “Project Agreement”) and a Base Agreement with Advanced Technology International, the Consortium Management Firm acting on behalf of the Medical CBRN Defense Consortium in connection with the partnership formerly known as Operation Warp Speed (the Base Agreement

together with the Project Agreement are referred to as the “USG Agreement”).

In February 2023, in connection with the execution of Modification 17 to the Project Agreement, the U.S.

government indicated to the Company that the award may not be extended past its current period of performance, December 31, 2023.

government indicated to the Company that the award may not be extended past its current period of performance, which is December 31, 2023.

Also, Modification 17 included provisions requiring that the payment of $ 60.0 million of consideration associated with manufacturing work now be contingent upon meeting certain milestones, including the delivery of up to 1.5 million doses of NVX-CoV2373 and development and regulatory milestones related to commercial readiness, expansion of the EUA and development of multiple vial presentations.

As of March 31, 2023, the Company constrained the total transaction price by $ 48.0 million for consideration associated with milestones that are not fully within the Company’s control.

This constraint, in addition to other contract changes included within Modification 17, resulted in an approximately $ 29 million cumulative reduction to revenue previously recognized under the contract for the three months ended March 31, 2023.

As of June 30, 2023, the Company constrained the total transaction price by $ 48.0 million for consideration associated with milestones that are not fully within the Company’s control.

Royalties and Other

During the three months ended March 31, 2023, the Company did no t recognize revenue related to sales-based royalties.

The Company recognized $ 7.4 million in revenue related to sales-based royalties during the three months ended March 31, 2022 .

During the three and six months ended June 30, 2023, the Company did no t recognize revenue related to milestone payments or sales-based royalties.

During the three and six months ended June 30, 2022, the Company recognized a $ 20.0 million milestone payment upon the first sale of NVX-CoV2373 in Japan and $ 1.7 million and $ 9.2 million, respectively in revenue related to sales-based royalties .

Note 4 – Collaboration, License, and Supply Agreements

Serum Institute

The Company previously granted SIIPL exclusive and non-exclusive licenses for the development, co-formulation, filling and finishing, registration, and commercialization of NVX-CoV2373, its proprietary COVID-19 variant antigen candidate(s), its quadrivalent influenza vaccine candidate, and its CIC vaccine candidate.

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As a result, it is uncertain whether the Company will receive future payments from Takeda under the terms and conditions of their current collaboration and licensing agreement.

Bill & Melinda Gates Medical Research Institute

In May 2023, we entered into a 3-year agreement with the Bill & Melinda Gates Medical Research Institute to provide our Matrix-M™ adjuvant for use in preclinical vaccine research.

Other Supply Agreements

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Pursuant to the Fujifilm Settlement Agreement, the Company is responsible for payment of up to $ 185.0 million (the “Settlement Payment”) to Fujifilm in connection with cancellation of manufacturing activity at FDBT under the CSA, of which (i) $ 47.8 million, constituting the initial reservation fee under the CSA, was credited against the Settlement Payment on September 30, 2022 and (ii) the remaining balance is to be paid in four equal quarterly installments of $ 34.3 million each, which began on March 31, 2023.

As of March 31, 2023, the remaining payment of $ 102.9 million was reflected in Accrued expenses.

As of June 30, 2023, the remaining payment of $ 68.6 million was reflected in Accrued expenses.

Under the Fujifilm Settlement Agreement, Fujifilm is required to use commercially reasonable efforts to mitigate the losses associated with the vacant manufacturing capacity caused by the termination of manufacturing activities at FDBT under the Fujifilm CSA, and the final two quarterly installments will be mitigated by any replacement revenue achieved by Fujifilm between July 1, 2023 and December 31, 2023.

In May 2023, the Company issued a notice to SK bioscience Co., Ltd.

(“SK bioscience) to cancel and wind down all drug substance and drug product manufacturing activities for supply by SK bioscience to the Company.

The Company recognized $ 20.4 million of research and development expense associated with a take-or-pay obligation that became due as a result of the cancellation.

The Company continues to assess its manufacturing needs and intends to modify its global manufacturing footprint consistent with its contractual obligations to supply, and anticipated demand for, NVX-CoV2373, and in doing so, recognizes that significant costs may be incurred.

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Three Months Ended

June 30, Six Months Ended

2023 2022 2023 2022

Net income (loss), basic $ 58,008 $ ( 510,485 ) $ ( 235,897 ) $ ( 307,077 )

Interest on convertible notes, net — 3,403

Interest on convertible notes 2,582 — — —

Net income (loss), dilutive 60,590 ( 510,485 ) ( 235,897 ) ( 307,077 )

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The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported in the consolidated balance sheets that sums to the total of such amounts shown in the consolidated statements of cash flows (in thousands):

March 31, 2023 December 31, 2022

June 30, 2023 December 31, 2022

Cash and cash equivalents $ 505,912 $ 1,336,883

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Cash, cash equivalents, and restricted cash $ 517,941 $ 1,348,845

(1) Classified as Other non-current assets as of March 31, 2023 and December 31, 2022, on the consolidated balance sheets.

(1) Classified as Other non-current assets as of June 30, 2023 and December 31, 2022, on the consolidated balance sheets.

Note 7 – 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, 2023 Fair Value at December 31, 2022

Fair Value at June 30, 2023 Fair Value at December 31, 2022

Assets Level 1 Level 2 Level 3 Level 1 Level 2 Level 3

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Total convertible notes payable $ — $ 130,957 $ — $ — $ 494,900 $ —

(1) All investments are classified as Cash and cash equivalents as of March 31, 2023 and December 31, 2022, on the consolidated balance sheets.

(1) All investments are classified as Cash and cash equivalents as of June 30, 2023 and December 31, 2022, 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, such as 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 convertible notes has been estimated using observable inputs, including the price of the Company’s common stock, implied volatility, interest rates, and credit spreads.

During the three months ended March 31, 2023 and 2022, the Company did not have any transfers between levels .

During the six months ended June 30, 2023 and 2022, the Company did not have any transfers between levels.

The amount in the Company’s consolidated balance sheets for accounts payable and accrued expenses approximates its fair value due to its short-term nature.

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Inventory consisted of the following (in thousands):

March 31, 2023 December 31, 2022

June 30, 2023 December 31, 2022

Raw materials $ 10,892 $ 13,912

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Total inventory $ 23,488 $ 36,683

Inventory write-downs as a result of excess, obsolescence, expiry, or other reasons, and losses on firm purchase commitments are recorded as a component of cost of sales in our consolidated statements of operations.

For the three months ended March 31, 2023, inventory write-downs were $ 12.5 million.

For the three months ended March 31, 2023, losses on firm purchase commitments were $ 7.7 million.

There were no inventory write-downs or losses on firm purchase commitments during the three months ended March 31, 2022 .

Inventory write-downs as a result of excess, obsolescence, expiry, or other reasons, and losses on firm purchase commitments, offset by recoveries of such commitments, are recorded as a component of cost of sales in our consolidated statements of operations.

For the three and six months ended June 30, 2023, inventory write-downs were $ 19.1 million and $ 31.5 million, respectively and losses on firm purchase commitments were $ 0.7 million and $ 8.5 million, respectively.

In addition, for the three and six months ended June 30, 2023 the Company recorded recoveries on firm purchase commitments of $ 17.9 million and $ 18.8 million, respectively, related primarily to negotiated reductions to previously recognized firm purchase commitments.

For the three and six months ended June 30, 2022, inventory write-downs and losses on firm purchase commitments were $ 155.7 million and $ 99.6 million, respectively.

Note 9 – Goodwill

The Company has one reporting unit, which has a negative equity value as of ended March 31, 2023 and December 31, 2022.

The change in the carrying amounts of goodwill for the three months ended March 31, 2023 was as follows (in thousands):

The Company has one reporting unit, which has a negative equity as of June 30, 2023 and December 31, 2022.

change in the carrying amounts of goodwill for the six months ended June 30, 2023 was as follows (in thousands):

Balance at December 31, 2022 $ 126,331

Currency translation adjustments 2,035

Balance at March 31, 2023 $ 129,827

Balance at June 30, 2023 $ 128,366

Note 10 – Leases

The Company has embedded leases related to supply agreements with contract manufacturing organizations (“CMOs”) and contract manufacturing and development organizations to manufacture NVX-CoV2373, as well as operating leases for its research and development and manufacturing facilities, corporate headquarters and offices, and certain equipment.

During the three months ended March 31, 2023, the Company continued to align its global manufacturing footprint as a result of its ongoing assessment of manufacturing needs consistent with its contractual obligations related to the supply, and anticipated demand for, NVX-CoV2373.

During the three months ended March 31, 2023, the Company recognized a short-term lease expense of $ 0.7 million, related to its embedded leases and no expense was recognized for the write off of right of use (“ROU”) assets that represented assets acquired for research and development activities that did not have an alternative future use at the commencement or modification of the lease.

During the three months ended March 31, 2022, the Company recognized a short-term lease expense of $ 78.1 million, related to its embedded leases and expensed $ 10.4 million of ROU write off.

During the three months ended March 31, 2023 and 2022, the Company recognized $ 0.5 million and $ 1.1 million, respectively, of interest expense on its finance lease liabilities.

The Company has embedded leases related to supply agreements with contract manufacturing organizations (“CMOs”) and contract manufacturing and development organizations to manufacture NVX-CoV2373, as well as leases for its research and development and manufacturing facilities, corporate headquarters and offices, and certain equipment.

During the six months ended June 30, 2023, the Company continued to align its global manufacturing footprint as a result of its ongoing assessment of manufacturing needs consistent with its contractual obligations related to the supply, and anticipated demand for, NVX-CoV2373.

During the three and six months ended June 30, 2023, the Company recognized a short-term lease benefit of $ 9.2 million and $ 8.5 million, respectively, related to its embedded leases, primarily as a result of a benefit of $ 9.5 million related to a settlement executed during the three months ended June 30, 2023.

During the three and six months ended June 30, 2022, the Company recognized a short-term lease expense of $ 5.8 million and $ 83.9 million respectively, related to its embedded leases and expensed $ 9.4 million and $ 19.8 million respectively, for the write off of right of use (“ROU”) assets that represented assets acquired for research and development activities that did not have an alternative future use at the commencement or modification of the lease ROU written off.

There were no ROU assets written off during the three and six months ended June 30, 2023, related to embedded leases.

During the three and six months ended June 30, 2023, the Company recognized $ 0.5 million and $ 0.9 million of interest expense, respectively, on its finance lease liabilities.

During the three and six months ended June 30, 2022, the Company recognized $ 2.3 million and $ 3.4 million of interest expense, respectively, on its finance lease liabilities.

During the three and six months ended June 30, 2023, the Company recorded an impairment charge of $ 5.9 million related to ROU facility leases used for research and development, manufacturing and offices space that are impacted by the Restructuring Plan (see Note 16).

Note 11 – Long-Term Debt

Total convertible notes payable consisted of the following (in thousands):

March 31, 2023 December 31, 2022

June 30, 2023 December 31, 2022

Current portion:

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Total non-current convertible notes payable $ 167,248 $ 166,466

During the three months ended March 31, 2023, the Company repaid the outstanding principal amount of $ 325.0 million on its 3.75 % Convertible notes due in 2023, together with accrued but unpaid interest on the maturity date.

In February 2023, the Company repaid the outstanding principal amount of $ 325.0 million on its 3.75 % Convertible notes due in 2023, together with accrued but unpaid interest on the maturity date.

The repayment was funded by the issuance of the 5.00 % Convertible notes due 2027 and the concurrent common stock offering in December 2022, as well as cash on hand.

The interest expense incurred in connection with the Notes consisted of the following (in thousands):

The effective interest rate of the 2027 Convertible notes is 6.2 %.

The interest expense incurred in connection with the convertible notes payable consisted of the following (in thousands):

Three Months Ended

June 30, Six Months Ended

2023 2022 2023 2022

Coupon interest $ 2,191 $ 3,047 $ 5,397 $ 6,094

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In June 2021, the Company entered into an At Market Issuance Sales Agreement (the "June 2021 Sales Agreement"), which allows it to issue and sell up to $ 500 million in gross proceeds of shares of its common stock.

As of March 31, 2023, the remaining balance available under the June 2021 Sales Agreement was approximately $ 318 million.

There were no sales recorded under the June 2021 Sales Agreement during the three months ended March 31, 2023.

During the three months ended March 31, 2022, the Company sold 2.2 million shares of its common stock resulting in net proceeds of approximately $ 179 million, under its June 2021 Sales Agreement.

During the three and six months ended June 30, 2023, the Company sold 7.9 million shares of its common stock under its June 2021 Sales Agreement resulting in net proceeds of approximately $ 68 million, of which $ 6 million was included in Prepaid expenses and other current assets as of June 30, 2022 and received in cash in July 2023.

As of June 30, 2023, the remaining balance available under the June 2021 Sales Agreement was approximately $ 249 million.

During the six months ended June 30, 2022, the Company sold 2.2 million shares of its common stock resulting in net proceeds of approximately $ 179 million, under its June 2021 Sales Agreement.

Note 13 – Stock-Based Compensation

In January 2023, the Company established the 2023 Inducement Plan (the “2023 Inducement Plan”), which provides for the granting of share-based awards to individuals who were not previously employees, or following a bona fide period of non-employment, as an inducement material to such individuals entering into employment with the Company.

The Company reserved 1.0 million shares of common stock for grant under the 2023 Inducement Plan.

As of March 31, 2023, there were 0.3 million shares available for issuance under the 2023 Inducement Plan.

The Company reserved 1.0 million shares of common stock for grants under the 2023 Inducement Plan.

As of June 30, 2023, there were 0.3 million shares available for issuance under the 2023 Inducement Plan.

The 2015 Stock Incentive Plan, as amended (“2015 Plan”), was approved at the Company's annual meeting of stockholders in June 2015.

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The 2015 Plan will expire on March 4, 2025.

As of March 31, 2023, there were 0.5 million shares available for issuance under the 2015 Plan.

As of June 30, 2023, there were 0.9 million shares available for issuance under the 2015 Plan.

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.

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Grants of share-based awards are generally subject to vesting over periods ranging from one to four years .

The Company recorded stock-based compensation expense in the consolidated statements of operations as follows (in thousands):

The Company recorded stock-based compensation expense in the consolidated statements of operations as follows (in

Three Months Ended

June 30, Six Months Ended

2023 2022 2023 2022

Cost of sales $ 998 $ — $ 1,516 $ —

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Total stock-based compensation expense $ 20,292 $ 38,048 $ 48,939 $ 70,981

Total stock-based compensation capitalized and included in inventory as of March 31, 2023 and December 31, 2022 was $ 1.7 million.

As of March 31, 2023, there was approximately $ 174 million of total unrecognized compensation expense related to unvested stock options, SARs, RSUs, and the Company’s Employee Stock Purchase Plan, as amended (“ESPP”).

Total stock-based compensation capitalized and included in inventory as of June 30, 2023 and December 31, 2022 was $ 1.7 million.

As of June 30, 2023, there was approximately $ 122 million of total unrecognized compensation expense related to unvested stock options, SARs, RSUs, and the Company’s Employee Stock Purchase Plan, as amended (“ESPP”).

This unrecognized non-cash compensation expense is expected to be recognized over a weighted-average period of approximately one year .

This estimate does not include the impact of other possible stock-based awards that may be made during future periods.

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 SARs on March 31, 2023.

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 SARs exercises and vesting of RSUs for the three months ended March 31, 2023 and 2022 was approximately $ 1.5 million and $ 5.6 million, respectively.

The aggregate intrinsic value of stock options and SARs exercises and vesting of RSUs for the six months ended June 30, 2023 and 2022 was approximately $ 2 million and $ 8 million, respectively.

Stock Options and Stock Appreciation Rights

The following is a summary of stock options and SARs activity under the 2023 Inducement Plan, 2015 Plan, and 2005 Plan for the three months ended March 31, 2023:

The following is a summary of stock options and SARs activity under the 2023 Inducement Plan, 2015 Plan, and 2005 Plan for the six months ended June 30, 2023:

2023 Inducement Plan 2015 Plan 2005 Plan

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Canceled — — ( 63,839 ) 51.41 ( 5,250 ) 36.60

Outstanding at March 31, 2023 358,600 $ 10.96 4,960,166 $ 38.73 58,475 $ 119.80

Shares exercisable at March 31, 2023 — $ — 311,560 $ 40.60 58,475 $ 119.80

The fair value of stock options granted under the 2023 Inducement Plan and the 2015 Plan was estimated at the date of grant using the Black-Scholes option-pricing model with the following assumptions:

Outstanding at June 30, 2023 358,600 $ 10.96 4,845,292 $ 39.15 58,475 $ 119.80

Shares exercisable at June 30, 2023 — $ — 3,295,810 $ 40.62 58,475 $ 119.80

The fair value of stock options granted under the 2023 Inducement Plan and the 2015 Plan was estimated at the date of

grant using the Black-Scholes option-pricing model with the following assumptions:

Three Months Ended

June 30, Six Months Ended

2023 2022 2023 2022

Weighted average Black-Scholes fair value of stock options granted $ 6.79

$ 43.21 $ 7.24

Risk-free interest rate 3.5 %- 3.9 %

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120.5 %- 136.7 %

120.4 %- 140.3 %

120.5 %- 136.7 %

Expected term (in years) 3.9 - 6.4

The total aggregate intrinsic value and weighted-average remaining contractual term of stock options and SARs outstanding under the 2023 Inducement Plan, 2015 Plan and 2005 Plan as of March 31, 2023 was approximately $ 0.9 million and 7.5 years, respectively.

The total aggregate intrinsic value and weighted-average remaining contractual term of stock options and SARs exercisable under the 2023 Inducement Plan, 2015 Plan and 2005 Plan as of March 31, 2023 was approximately $ 0.7 million and 6.5 years, respectively.

The total aggregate intrinsic value and weighted-average remaining contractual term of stock options and SARs outstanding under the 2023 Inducement Plan, 2015 Plan and 2005 Plan as of June 30, 2023 was approximately $ 1.7 million and 7.3 years, respectively.

The total aggregate intrinsic value and weighted-average remaining contractual term of stock options and SARs exercisable under the 2023 Inducement Plan, 2015 Plan and 2005 Plan as of June 30, 2023 was approximately $ 1.1 million and 6.3 years, respectively.

Restricted Stock Units

The following is a summary of RSU activity for the three months ended March 31, 2023:

The following is a summary of RSU activity for the six months ended June 30, 2023:

2023 Inducement Plan 2015 Plan

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Forfeited — $ — ( 637,727 ) 29.46

Outstanding and unvested at March 31, 2023 308,390 $ 10.96 4,265,761 $ 28.26

Outstanding and unvested at June 30, 2023 308,390 $ 10.96 3,856,669 $ 26.23

Employee Stock Purchase Plan

The ESPP was approved at the Company's annual meeting of stockholders in June 2013.

The ESPP currently authorizes an aggregate of 1.1 million shares of common stock to be purchased, and the aggregate amount of shares will continue to increase 5 % on each anniversary of its adoption up to a maximum of 1.65 million shares.

The ESPP currently authorized an aggregate of 1.2 million shares of common stock to be purchased, and the aggregate amount of shares will continue to increase 5 % on each anniversary of its adoption up to a maximum of 1.65 million shares.

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, 2023, there were 0.5 million shares available for issuance under the ESPP.

As of June 30, 2023, there were 0.6 million shares available for issuance under the ESPP.

Note 14 – Income Taxes

The Company evaluates the available positive and negative evidence to estimate whether sufficient future taxable income will be generated to permit use of the existing deferred tax assets.

A significant piece of objective evidence evaluated was the cumulative loss incurred over the three-year period ended March 31, 2023 and that the Company has historically generated pretax losses.

A significant piece of objective evidence evaluated was the cumulative loss incurred over the three-year period ended June 30, 2023 and that the Company has historically generated pretax losses.

Such objective evidence limits the ability to consider other subjective evidence, such as projections for future growth.

On the basis of this evaluation, as of March 31, 2023, the Company continued to maintain a full valuation allowance against its deferred tax assets, except to the extent Net Operating Losses (“NOLs”) have been used to reduce taxable income.

On the basis of this evaluation, as of June 30, 2023, the Company continued to maintain a full valuation allowance against its deferred tax assets, except to the extent Net Operating Losses (“NOLs”) have been used to reduce taxable income.

The Company’s remaining U.S.

Federal NOLs are subject to limitation in accordance with the 2017 Tax Cuts and Jobs Act (“TCJA”), which limits allowable NOL deductions to 80% of federal taxable income.

Effective January 1, 2022, a provision of the TCJA has taken effect creating a significant change to the treatment of research and experimental expenditures under Section 174 of the IRC (“Sec.

Effective January 1, 2022, a provision of the TCJA has taken effect creating a significant change to the treatment of

research and experimental expenditures under Section 174 of the IRC (“Sec.

174 expenses”).

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174 expenses will be capitalized and amortized over a 15-year period.

The Company recognized federal, state, and foreign income tax expense of $ 1.2 million and $ 0.6 million, in total, for the three months ended March 31, 2023 and 2022, respectively.

The Company recognized foreign withholding tax expense on royalties of $ 2.1 million for the three months ended March 31, 2022.

The Company did no t recognize any foreign withholding tax expense on royalties for the three months ended March 31, 2023.

During the three months ended June 30, 2023 and 2022, the Company recognized federal, state, and foreign income tax benefit of $ 0.1 million and income tax expense of $ 1.4 million, respectively.

During the six months ended June 30, 2023 and 2022, the Company recognized income tax expense of $ 1.0 million and $ 1.9 million, respectively.

The Company recognized foreign withholding tax expense on royalties of $ 2.2 million for the six months ended June 30, 2022.

The Company did no t recognize any foreign withholding tax expense on royalties for the three months ended June 30, 2022 and the three and six months ended June 30, 2023.

Note 15 – Commitments and Contingencies

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On January 26, 2022, the Maryland Court entered an order designating David Truong, Nuggehalli Balmukund Nandkumar, and Jeffrey Gabbert as co-lead plaintiffs in the Sinnathurai Action.

The co-lead plaintiffs filed a consolidated amended complaint on March 11, 2022,

alleging that the defendants made certain purportedly false and misleading statements concerning the Company’s ability to manufacture NVX-CoV2373 on a commercial scale and to secure the NVX-CoV2373’s regulatory approval.

The co-lead plaintiffs filed a consolidated amended complaint on March 11, 2022, alleging that the defendants made certain purportedly false and misleading statements concerning the Company’s ability to manufacture NVX-CoV2373 on a commercial scale and to secure the NVX-CoV2373’s regulatory approval.

The amended complaint defines the purported class as those stockholders who purchased the Company’s securities between February 24, 2021 and October 19, 2021.

On April 25, 2022, defendants filed a motion to dismiss the consolidated amended complaint.

On April 25, 2022, the defendants filed a motion to dismiss the consolidated amended complaint.

On December 12, 2022, the Maryland Court issued a ruling granting in part and denying in part defendants’ motion to dismiss.

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On December 27, 2022, the Company filed its answer and affirmative defenses.

After the Sinnathurai Action was filed, seven derivative lawsuits were filed:

After the Sinnathurai Action was filed, eight derivative lawsuits were filed:

(i) Robert E.

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Erck, et al., No.

8:22-cv-00024-TDC (the “Kirst Action”), (iv) Amy Snyder v.

C-15-CV-21-000618 (the “Kirst Action”), (iv) Amy Snyder v.

Erck, et al., No.

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1:22-cv-01417-TDC (the “Blackburn Action”), (vi) Diego J.

(the “Mesa Action”), and (vii) Sean Acosta v.

(the “Acosta Action”).

Erck, et al., No.

2022-0770-NAC (the “Mesa Action”), (vii) Sean Acosta v.

Erck, et al., No.

2022-1133-NAC (the “Acosta Action”), and (viii) Jared Needelman v.

Erck, et al., No.

C-15-CV-23-001550 (the “Needelman Action”).

The Meyer, Yung, Snyder, and Blackburn Actions were filed in the Maryland Court.

The Kirst Action was filed in the Circuit Court for Montgomery County, Maryland, and shortly thereafter removed to the Maryland Court by the defendants.

The Needleman Action was also filed in the Circuit Court for Montgomery County, Maryland.

The Mesa and Acosta Actions were filed in the Delaware Court of Chancery (the “Delaware Court”).

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On February 10, 2023, defendants filed a motion to dismiss the Second Consolidated Derivative Action.

Plaintiffs’ filed their opposition to the motion to dismiss on April 11, 2023.

Defendant’s reply brief in further support of their motion to dismiss is due by May 11, 2023.

The plaintiffs filed their opposition to the motion to dismiss on April 11, 2023.

Defendants filed their reply brief in further support of their motion to dismiss on May 11, 2023.

On July 21, 2022, the Maryland Court issued a memorandum opinion and order remanding the Kirst Action to state court.

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On October 3, 2022, the Delaware Court entered an order granting the parties’ request to stay all proceedings and deadlines in the Mesa Action pending the earlier of dismissal of the Sinnathurai Action or the filing of an answer to the operative complaint in the Sinnathurai Action.

On January 9, 2023, the court entered an order granting the parties’ request to set a briefing schedule in connection with a motion to stay that defendants intended to file.

Pursuant to the order, defendants filed a motion to stay on January 18, 2023.

The plaintiff filed his opposition on February 8, 2023.

Defendants filed their reply on February 22, 2023.

On February 28, 2023, the court granted Defendants’ motion and stayed the Mesa Action pending the entry of a final, non-appealable judgment in the Second Consolidated Derivative Action.

On January 9, 2023, following the ruling on the motion to dismiss the Sinnathurai Action, the Delaware Court entered an order granting the Mesa Action parties’ request to set a briefing schedule in connection with a motion to stay by defendants.

On February 28, 2023, the court granted the defendants’ motion and stayed the Mesa Action pending the entry of a final, non-appealable judgment in the Second Consolidated Derivative Action.

On December 7, 2022, the Acosta Action was filed.

1 unchanged sentence

On March 9, 2023, the court entered an order granting the parties’ request to stay the Acosta Action pending the entry of a final, non-appealable judgment in the Second Consolidated Derivative Action.

On June 28, 2023 the Company, along with representatives from its insurance carriers, met with the plaintiffs and the plaintiffs of the Sinnathurai Action in mediation to engage in potential settlement discussions.

The parties continue to discuss whether an amicable resolution is possible.

On April 17, 2023, the Needelman Action was filed.

On July 12, 2023, the parties filed a stipulation and proposed order to stay the Needelman Action pending the Maryland Court’s decision on the motion to dismiss in the Second Consolidated Derivative Action.

The financial impact of this claim, as well as the claims discussed above, is not estimable.

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The Company filed its responsive brief on January 30, 2023 and the appellant filed his reply brief on February 14, 2023.

The financial impact of this claim, as well as the claims discussed above, is not estimable.

On March 29, 2022, Par submitted a demand for arbitration against the Company with the American Arbitration Association, alleging that the Company breached certain provisions of the Manufacturing and Services Agreement (the “Par MSA”) that the Company entered into with Par in September 2020 to provide fill-finish manufacturing services for NVX-CoV2373.

On June 8, 2023, the Supreme Court affirmed the Court of Chancery’s denial of the plaintiff’s fee application.

The case was closed on June 26, 2023.

On March 29, 2022, Par Sterile Products, LLC (“Par”) submitted a demand for arbitration against the Company with the American Arbitration Association, alleging that the Company breached certain provisions of the Manufacturing and Services Agreement (the “Par MSA”) that the Company entered into with Par in September 2020 to provide fill-finish manufacturing services for NVX-CoV2373.

On April 4, 2023 the parties entered into a Settlement Agreement and Release of Claims pursuant to which Novavax agreed to pay $ 27.0 million to Par, which was fully accrued for as of March 31, 2023.

Novavax characterized the payment as a $ 15.0 million termination fee due under the Par MSA and a $ 12.0 million settlement payment.

Novavax characterized the payment as a $ 15.0 million termination fee and a $ 12.0 million settlement payment.

Because Par and its parent company, Endo International plc, are parties to Chapter 11 bankruptcy proceedings, the Settlement Agreement and Release of Claims and the payment due thereunder required, and subsequently received, approval from the bankruptcy court.

The Company has made the payment required by the Settlement Agreement and Release of Claims, and, subject to the non-occurrence of certain contingencies, the arbitration will be dismissed on or about July 13, 2023.

The Company has made the payment required by the Settlement Agreement and Release of Claims, and the arbitration was dismissed with prejudice following a joint motion by Par and Novavax on August 1, 2023.

On November 18, 2022, the Company delivered written notice to Gavi to terminate the Gavi APA based on Gavi’s failure to procure the purchase of 350 million doses of NVX-CoV2373 from the Company as required by the Gavi APA.

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As of December 31, 2022, the remaining Gavi Advance Payment Amount of $ 697.4 million, pending resolution of the dispute with Gavi related to a return of the remaining Advance Payment Amount, was reclassified from Deferred revenue to Other current liabilities in the Company’s consolidated balance sheet.

On January 24, 2023, Gavi filed a demand for arbitration with the International Court of Arbitration based on the claims described above.

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On April 5, 2023, Gavi filed its Reply to the Company’s Counterclaims.

Arbitration is inherently uncertain, and while the Company believes that it is entitled to retain the remaining Advance Payment Amount received from Gavi, it is possible that it will be required to refund all or a portion of the remaining Advance Payment Amount from Gavi.

The arbitration hearing is scheduled for July 2024, with a written decision to follow.

The Company is also involved in various other legal proceedings arising in the normal course of business.

Although the outcomes of these other legal proceedings are inherently difficult to predict, the Company do not expect the resolution of these other legal proceedings to have a material adverse effect on its financial position, results of operations, or cash flows.

Note 16 – Subsequent Events

In December 2020, the Company entered into an APA with the Commonwealth of Australia for the purchase of doses of NVX-CoV2373 (the “Australia APA”).

In April 2023, the Company entered into an amendment to the Australia APA that reduced the number of doses to be delivered under the Australia APA with a commensurate increase in the per-dose price, such that the total contract value of the Australia APA was maintained, with doses to be delivered through 2024.

In January 2021, the Company entered into an APA with Her Majesty the Queen in Right of Canada as represented by the Minister of Public Works and Government Services for the purchase of doses of NVX-CoV2373 (the “Canada APA”).

In April 2023, the Company entered into an amendment to the Canada APA under which it will receive a payment of $ 100.4 million for the forfeiture of doses originally scheduled for delivery in 2022.

In May 2023, the Company announced a global restructuring and cost reduction plan.

In May 2023, the Company announced that its CIC, stand-alone influenza and high-dose COVID vaccine candidates all showed a reassuring preliminary safety profile as well as comparable reactogenicity to individual Novavax influenza and COVID vaccine candidates or authorized influenza vaccine comparators.

Additionally, all three vaccines demonstrated preliminary robust immune responses.

The primary endpoint evaluated the safety of different formulations of the CIC vaccine candidate and the quadrivalent influenza vaccine candidate compared to Fluad® and Fluzone High-Dose Quadrivalent® (Fluzone HD), as well as a high-dose COVID vaccine candidate in adults aged 50 through 80.

All three vaccine candidates contained Novavax’s patented Matrix-M adjuvant and showed reassuring preliminary safety profiles and reactogenicity that was comparable to Fluad and Fluzone HD.

Although the outcomes of these other legal proceedings are inherently difficult to predict, the Company does not expect the resolution of these other legal proceedings to have a material adverse effect on its financial position, results of operations, or cash flows.

Note 16 – Restructuring

During the three and six months ended June 30, 2023, the restructuring charge recorded by the Company as a result of the Restructuring Plan includes (in thousands):

Severance and employee benefit costs $ 4,643

Impairment of assets 10,081

Total Restructuring charge (1)

(1) Restructuring charges of $ 0.5 million, $ 2.7 million and $ 11.5 million are included in Cost of sales, Research and development and Selling, general, and administrative expenses, respectively, in the Consolidated Statements of Operations for the three and six months ended June 30, 2023.

These charges reflect substantially all expected restructuring charges under the Restructuring Plan.

Severance and employee benefit costs

Employees affected by the reduction in force under the Restructuring Plan are entitled to receive severance payments and certain termination benefits.

The Company recorded a severance and termination benefit cost in full for employees who were notified of their termination in the three months ended June 30, 3023 and had no requirements for future service.

The Company paid a total of $ 3.6 million for the severance and employee benefit costs during the three months ended June 30, 2023, and the remaining liability of $ 1.0 million is included in Accrued expenses in the Company’s Consolidated Balance Sheet as of June 30, 2023.

Impairment of assets

In connection with the Restructuring Plan, the Company evaluated its long-lived assets for impairment including certain leased laboratory and office spaces located in Gaithersburg, Maryland.

The Company performed an impairment evaluation for the applicable long-lived assets which is subject to judgment and actual results may vary from the estimates, resulting in potential future adjustments to amounts recorded.

During the three and six months ended June 30, 2023, the Company recorded an impairment charge of $ 10.1 million related to the impairment of long-lived assets, including $ 5.9 million related to ROU assets for facility leases.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1. Financial Statements