What changed in this filing

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Item 9A. Controls and Procedures

2021-02-25 compared with 2020-03-26 · 119 added, 38 removed, 178 unchanged (47% of the section changed)

4 unchanged sentences

Management’s Report on Internal Control Over Financial Reporting

Due to a transition period established by SEC rules applicable to newly public companies, this Annual Report on Form 10-K does not include a report of management’s assessment regarding internal control over financial reporting.

Attestation Report of the Registered Public Accounting Firm

This Annual Report on Form 10-K does not include an attestation report of our registered public accounting firm due to an exemption provided by the JOBS Act for “emerging growth companies.”

Management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rules 13a-15(f)) under the Exchange Act.

Our internal control over financial reporting is designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of consolidated financial statements for external purposes in accordance with generally accepted accounting principles.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.

Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

Management assessed the effectiveness of our internal control over financial reporting based on the framework set forth by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”) in Internal Control—Integrated Framework (2013 Framework).

Based on our assessment, we concluded that our internal control over financial reporting was effective as of December 31, 2020.

The effectiveness of our internal control over financial reporting has been audited by Ernst & Young LLP, an independent registered public accounting firm, as stated in their attestation report herein, which expresses an unqualified opinion on the effectiveness of our internal control over financial reporting as of December 31, 2020.

Changes in Internal Control Over Financial Reporting

There were no changes in our internal control over financial reporting that occurred during our fourth fiscal quarter ended December 31, 2020 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Report of Independent Registered Public Accounting Firm

To the Stockholders and the Board of Directors

of Vir Biotechnology, Inc.

Opinion on Internal Control over Financial Reporting

We have audited Vir Biotechnology, Inc.’s internal control over financial reporting as of December 31, 2020, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria).

In our opinion, Vir Biotechnology, Inc.

(the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, 2020, based on the COSO criteria.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2020 and 2019, the related

consolidated statements of operations, comprehensive loss, convertible preferred stock and stockholders’ equity (deficit) and cash flows for each of the three years in the period ended December 31, 2020, and the related notes and our report dated February 25, 2021 expressed an unqualified opinion thereon.

Basis for Opinion

The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting included in the accompanying Management's Report on Internal Control over Financial Reporting.

Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit.

We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S.

federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audit in accordance with the standards of the PCAOB.

Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects.

Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances.

We believe that our audit provides a reasonable basis for our opinion.

Definition and Limitations of Internal Control Over Financial Reporting

A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles.

A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company;

(2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company;

and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.

/s/ Ernst & Young LLP

Redwood City, California

February 25, 2021

Other Information.

24 unchanged sentences

333-233604), filed with the SEC on September 3, 2019).

Amended and Restated Warrant, issued to Takeda Ventures, Inc (incorporated herein by reference to Exhibit 4.3 to the Company’s Registration Statement on Form S-1 (File No.

333-233604), filed with the SEC on September 3, 2019).

Description of Capital Stock.

Description of Capital Stock (incorporated herein by reference to Exhibit 4.4 to the Company’s Form 10-K (File No.

001-39083), filed with the SEC on March 26, 2020).

Vir Biotechnology, Inc.

9 unchanged sentences

Form of Restricted Stock Unit Grant Notice and Unit Award Agreement under Vir Biotechnology, Inc.

2019 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.4 to the Company’s Registration Statement on Form S-1 (File No.

333-233604), filed with the SEC on September 3, 2019).

2019 Equity Incentive Plan.

Vir Biotechnology, Inc.

4 unchanged sentences

333-233604), filed with the SEC on September 3, 2019).

Non-Employee Director Compensation Policy (incorporated herein by reference to Exhibit 10.8 to the Company’s Registration Statement on Form S-1 (File No.

333-233604), filed with the SEC on September 3, 2019).

Non-Employee Director Compensation Policy.

Amended and Restated Employment Letter Agreement between the Company and George Scangos, dated August 27, 2019 (incorporated herein by reference to Exhibit 10.9 to the Company’s Registration Statement on Form S-1 (File No.

4 unchanged sentences

333-233604), filed with the SEC on September 3, 2019).

First Amendment to Amended and Restated Employment Letter Agreement between the Company and Michael Kamarck, dated March 13, 2020.

First Amendment to Amended and Restated Employment Letter Agreement between the Company and Michael Kamarck, dated March 13, 2020 (incorporated herein by reference to Exhibit 10.12 to the Company’s Form 10-K (File No.

001-39083), filed with the SEC on March 26, 2020).

Amended and Restated Employment Letter Agreement between the Company and Phil Pang, dated August 27, 2019 (incorporated herein by reference to Exhibit 10.12 to the Company’s Registration Statement on Form S-1 (File No.

4 unchanged sentences

333-233604), filed with the SEC on September 3, 2019).

Employment Letter Agreement between the Company and Steven Rice, dated August 22, 2019 (incorporated herein by reference to Exhibit 10.3 to the Company’s Form 10-Q (File No.

001-39083), filed with the SEC on November 10, 2020).

Promotion Letter Agreement between the Company and Steven Rice, dated July 30, 2020 (incorporated herein by reference to Exhibit 10.4 to the Company’s Form 10-Q (File No.

001-39083), filed with the SEC on November 10, 2020).

Vir Biotechnology, Inc.

5 unchanged sentences

333-233604), filed with the SEC on September 3, 2019).

Amendment No.

1 to the Collaboration and License Agreement between the Company and Alnylam Pharmaceuticals, Inc., dated December 17, 2019.

Amendment No.

2 to the Collaboration and License Agreement between the Company and Alnylam Pharmaceuticals, Inc., dated March 3, 2020.

Amendment No.1 to the Collaboration and License Agreement between the Company and Alnylam Pharmaceuticals, Inc., dated December 17, 2019 (incorporated herein by reference to Exhibit 10.19 to the Company’s Form 10-K (File No.

001-39083), filed with the SEC on March 26, 2020).

Amendment No.2 to the Collaboration and License Agreement between the Company and Alnylam Pharmaceuticals, Inc., dated March 3, 2020 (incorporated herein by reference to Exhibit 10.20 to the Company’s Form 10-K (File No.

001-39083), filed with the SEC on March 26, 2020).

Amendment No.3 to the Collaboration and License Agreement between the Company and Alnylam Pharmaceuticals, Inc., dated April 1, 2020 (incorporated herein by reference to Exhibit 10.21 to the Company’s Registration Statement on Form S-1 (File No.

333-239689), filed with the SEC on July 6, 2020).

Letter Agreement between the Company and Alnylam Pharmaceuticals, Inc., dated December 23, 2020.

Common Stock Issuance Agreement between the Company and Alnylam Pharmaceuticals, Inc., dated October 16, 2017 (incorporated herein by reference to Exhibit 10.18 to the Company’s Registration Statement on Form S-1 (File No.

1 unchanged sentence

Amendment No.

1 to the Common Stock Issuance Agreement between the Company and Alnylam Pharmaceuticals, Inc., dated December 17, 2019.

1 to the Common Stock Issuance Agreement between the Company and Alnylam Pharmaceuticals, Inc., dated December 17, 2019 (incorporated herein by reference to Exhibit 10.22 to the Company’s Form 10-K (File No.

001-39083), filed with the SEC on March, 26, 2020).

Letter Agreement between the Company and Alnylam Pharmaceuticals, Inc., dated November 13, 2018 (incorporated herein by reference to Exhibit 10.19 to the Company’s Registration Statement on Form S-1 (File No.

2 unchanged sentences

333-233604), filed with the SEC on September 3, 2019).

Amendment No.

1 to License Agreement between the Company and MedImmune, LLC, dated September 1, 2020.

Second Revised and Restated Master License Agreement between the Company and Oregon Health & Science University, dated August 27, 2019 (incorporated herein by reference to Exhibit 10.21 to the Company’s Registration Statement on Form S-1 (File No.

13 unchanged sentences

Amendment No.

1 to the Grant Agreement between the Company and the Bill & Melinda Gates Foundation, dated April 18, 2019.

1 to the Grant Agreement between the Company and the Bill & Melinda Gates Foundation, dated April 18, 2019 (incorporated herein by reference to Exhibit 10.31 to the Company’s Form 10-K (File No.

001-39083), filed with the SEC on March 26, 2020).

Amendment No.

2 to the Grant Agreement between the Company and the Bill & Melinda Gates Foundation, dated February 24, 2020.

2 to the Grant Agreement between the Company and the Bill & Melinda Gates Foundation, dated February 24, 2020 (incorporated herein by reference to Exhibit 10.32 to the Company’s Form 10-K (File No.

001-39083), filed with the SEC on March 26, 2020).

Amendment No.

3 to the Grant Agreement between the Company and the Bill & Melinda Gates Foundation, dated May 22, 2020.

Amendment No.

4 to the Grant Agreement between the Company and the Bill & Melinda Gates Foundation, dated December 8, 2020.

Grant Agreement between the Company and the Bill & Melinda Gates Foundation, dated March 16, 2018 (incorporated herein by reference to Exhibit 10.27 to the Company’s Registration Statement on Form S-1 (File No.

1 unchanged sentence

Amendment No.

1 to the Grant Agreement between the Company and the Bill & Melinda Gates Foundation, dated April 22, 2019.

1 to the Grant Agreement between the Company and the Bill & Melinda Gates Foundation, dated April 22, 2019 (incorporated herein by reference to Exhibit 10.34 to the Company’s Form 10-K (File No.

001-39083), filed with the SEC on March 26, 2020).

Amendment No.

2 to the Grant Agreement between the Company and the Bill & Melinda Gates Foundation, dated October 28, 2019.

2 to the Grant Agreement between the Company and the Bill & Melinda Gates Foundation, dated October 28, 2019 (incorporated herein by reference to Exhibit 10.35 to the Company’s Form 10-K (File No.

001-39083), filed with the SEC on March 26, 2020).

Amendment No.

3 to the Grant Agreement between the Company and the Bill & Melinda Gates Foundation, dated May 29, 2020 (incorporated herein by reference to Exhibit 10.12 to the Company’s Form 10-Q (File No.

001-39083), filed with the SEC on August 11, 2020).

Amended and Restated Exclusive License Agreement between the Company (as successor in interest to Humabs BioMed SA (f/k/a Humabs Holding GmbH)) and the Institute for Research in Biomedicine, dated December 16, 2011 (incorporated herein by reference to Exhibit 10.28 to the Company’s Registration Statement on Form S-1 (File No.

12 unchanged sentences

333-233604), filed with the SEC on September 3, 2019).

Second Amendment to Exclusive License Agreement between the Company and The Rockefeller University, dated September 28, 2020 .

Sub-License and Collaboration Agreement between the Company (as successor in interest to Humabs BioMed SA) and MedImmune, LLC, dated March 20, 2012 (incorporated herein by reference to Exhibit 10.35 to the Company’s Registration Statement on Form S-1 (File No.

18 unchanged sentences

333-233604), filed with the SEC on September 3, 2019).

Sublease Agreement between the Company and Dropbox, Inc., dated November 4, 2020.

Patent License Agreement between the Company and Xencor, Inc., dated August 15, 2019 (incorporated herein by reference to Exhibit 10.44 to the Company’s Registration Statement on Form S-1 (File No.

333-233604), filed with the SEC on September 3, 2019).

Patent License Agreement between the Company and Xencor, Inc., dated March 25, 2020 (incorporated herein by reference to Exhibit 99.1 to the Company’s Form 8-K (File No.

001-39083), filed with the SEC on June 19, 2020).

Preliminary Collaboration Agreement between the Company, GlaxoSmithKline Intellectual Property Development Limited and GlaxoSmithKline Biologicals SA, dated April 5, 2020 (incorporated herein by reference to Exhibit 10.53 to the Company’s Registration Statement on Form S-1 (File No.

333-239689), filed with the SEC on July 6, 2020).

Definitive Collaboration Agreement between the Company, Glaxo Wellcome UK Limited and Beecham S.A., dated June 9, 2020 (incorporated herein by reference to Exhibit 10.54 to the Company’s Registration Statement on Form S-1 (File No.

333-239689), filed with the SEC on July 6, 2020).

Stock Purchase Agreement between the Company and Glaxo Group Limited, dated April 5, 2020 (incorporated herein by reference to Exhibit 10.55 to the Company's Registration Statement on Form S-1 (File No.

333-239689), filed with the SEC on July 6, 2020) .

Clinical Development and Manufacturing Agreement between the Company and Biogen Inc., dated May 22, 2020 (incorporated herein by reference to Exhibit 10.56 to the Company’s Registration Statement on Form S-1 (File No.

333-239689), filed with the SEC on July 6, 2020).

Binding Letter Agreement between the Company and Samsung Biologics Co., Ltd., dated April 9, 2020 (incorporated herein by reference to Exhibit 10.57 to the Company’s Registration Statement on Form S-1 (File No.

333-239689), filed with the SEC on July 6, 2020).

Assignment and Novation Agreement among the Company, GlaxoSmithKline Trading Services Limited and Samsung Biologics Co., Ltd., dated July 31, 2020 (incorporated herein by reference to Exhibit 99.2 to the Company’s Form 8-K (File No.

001-39083), filed with the SEC on August 7, 2020).

Development and Manufacturing Collaboration Agreement between the Company and Wuxi Biologics (Hong Kong) Limited, dated February 25, 2020 (incorporated herein by reference to Exhibit 10.58 to the Company’s Registration Statement on Form S-1 (File No.

333-239689), filed with the SEC on July 6, 2020).

Letter of Intent between the Company and Wuxi Biologics (Hong Kong) Limited, dated June 15, 2020 (incorporated herein by reference to Exhibit 10.59 to the Company’s Registration Statement on Form S-1 (File No.

333-239689), filed with the SEC on July 6, 2020).

Assignment and Novation Agreement among the Company, GlaxoSmithKline Trading Services Limited and WuXi Biologics (Hong Kong) Limited, dated July 29, 2020 (incorporated herein by reference to Exhibit 99.1 to the Company’s Form 8-K (File No.

001-39083), filed with the SEC on August 7, 2020).

Sales Agreement, dated as of November 10, 2020, by and between the registrant and Cowen and Company, LLC.

(incorporated by reference to Exhibit 1.2 to the Company’s registration statement on Form S-3 (Filed No.

333-250013), filed with the SEC on November 10, 2020).

List of subsidiaries of the Company (incorporated herein by reference to Exhibit 21.1 to the Company’s Registration Statement on Form S-1 (File No.

15 unchanged sentences

Certain portions of this exhibit (indicated by “[***]”) have been omitted pursuant to confidential treatment.

The certification attached as Exhibit 32.1 that accompany this Annual Report on Form 10-K is not deemed filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Annual Report on Form 10-K, irrespective of any general incorporation language contained in such filing.

The certification attached as Exhibit 32.1 that accompany this Annual Report on Form 10-K is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Annual Report on Form 10-K, irrespective of any general incorporation language contained in such filing.

Form 10-K Summary

1 unchanged sentence

VIR BIOTECHNOLOGY, INC.

March 26, 2020

February 25, 2021

/s/ George Scangos

2 unchanged sentences

(Principal Executive Officer)

March 26, 2020

February 25, 2021

/s/ Howard Horn

Chief Financial Officer and Secretary

(Principal Financial Officer)

(Principal Financial and Accounting Officer)

POWER OF ATTORNEY

3 unchanged sentences

President, Chief Executive Officer and

March 26, 2020

February 25, 2021

George Scangos, Ph.D.

2 unchanged sentences

Chief Financial Officer and Secretary (Principal Financial and Accounting Officer)

March 26, 2020

/s/ Vicki Sato, Ph.D.

February 25, 2021

/s/ Vicki Sato

Chairman of the Board of Directors

March 26, 2020

February 25, 2021

Vicki Sato, Ph.D.

/s/ Kristina Burow

March 26, 2020

Kristina Burow

/s/ Janet Napolitano

February 25, 2021

Janet Napolitano

/s/ Robert More

March 26, 2020

February 25, 2021

/s/ Robert Nelsen

March 26, 2020

February 25, 2021

Robert Nelsen

/s/ Dipchand Nishar

March 26, 2020

February 25, 2021

Dipchand Nishar

/s/ Robert Perez

March 26, 2020

February 25, 2021

/s/ Saira Ramasastry

March 26, 2020

February 25, 2021

Saira Ramasastry

/s/ Phillip Sharp, Ph.D.

March 26, 2020

/s/ Phillip Sharp

February 25, 2021

Phillip Sharp, Ph.D.

/s/ Elliott Sigal

February 25, 2021

Elliott Sigal, M.D., Ph.D.

/s/ Jeffrey S.

February 25, 2021

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-K

Item 9A. Controls and Procedures