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.

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 10-Q

 

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2021

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission File Number: 001-39083

 

Vir Biotechnology, Inc.

(Exact name of registrant as specified in its charter)

 

 

Delaware

81-2730369

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

499 Illinois Street, Suite 500, San Francisco, California

94158

(Address of principal executive offices)

(Zip Code)

 

Registrant’s telephone number, including area code: (415) 906-4324

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange on which registered

Common stock, par value $0.0001 per share

 

VIR

 

Nasdaq Global Select Market

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

 

 

Accelerated filer

 

 

 

 

 

Non-accelerated filer

 

 

Smaller reporting company

 

 

 

 

 

 

 

 

 

 

 

 

Emerging growth company

 

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No

As of November 1, 2021, the registrant had 130,880,159 shares of common stock, $0.0001 par value per share, outstanding.

 


Table of Contents

 

 

 

Page

PART I.

FINANCIAL INFORMATION

 

Item 1.

Financial Statements (unaudited)

4

 

Condensed Consolidated Balance Sheets as of September 30, 2021 and December 31, 2020 (unaudited)

4

 

Condensed Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2021 and 2020 (unaudited)

5

 

Condensed Consolidated Statements of Comprehensive Income (Loss) for the Three and Nine Months Ended September 30, 2021 and 2020 (unaudited)

6

 

Condensed Consolidated Statements of Stockholders’ Equity for the Three and Nine Months Ended September 30, 2021 and 2020 (unaudited)

7

 

Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2021 and 2020 (unaudited)

9

 

Notes to Unaudited Condensed Consolidated Financial Statements

10

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

34

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

45

Item 4.

Controls and Procedures

46

PART II.

OTHER INFORMATION

 

Item 1.

Legal Proceedings

47

Item 1A.

Risk Factors

47

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

84

Item 3.

Defaults Upon Senior Securities

84

Item 4.

Mine Safety Disclosures

84

Item 5.

Other Information

84

Item 6.

Exhibits

85

Signatures

86

 

 

1


SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This Quarterly Report on Form 10-Q contains forward-looking statements about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q, including statements regarding our strategy, future financial condition, future operations, research and development, planned clinical trials and preclinical studies, technology platforms, the timing and likelihood of regulatory filings and approvals for our product candidates, our ability to commercialize our product candidates, the potential benefits of collaborations, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology.

 

We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of known and unknown risks, uncertainties and assumptions described in the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this report. Other sections of this report may include additional factors that could harm our business and financial performance. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for our management to predict all risk factors nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements.

 

In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. Although we believe that we have a reasonable basis for each forward-looking statement contained in this report, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur at all. You should refer to the section titled “Risk Factors” for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. Except as required by law, we undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.

 

 

2


RISK FACTOR SUMMARY

 

Investing in our securities involves a high degree of risk. Below is a summary of material factors that make an investment in our securities speculative or risky. Importantly, this summary does not address all of the risks that we face. Additional discussion of the risks summarized in this risk factor summary, as well as other risks that we face, can be found under the heading “Risk Factors” in Part II of this Quarterly Report on Form 10-Q.

 

Our business is subject to a number of risks of which you should be aware before making a decision to invest in our common stock. These risks include, among others, the following:

We have incurred significant net losses since inception and anticipate that we will continue to incur net losses for the foreseeable future and therefore, may not be able maintain profitability.
Our limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability.
We will require substantial additional funding to finance our operations. If we are unable to raise capital when needed, we could be forced to delay, reduce or terminate certain of our development programs or other operations.
We are committing substantial financial resources and personnel and making substantial capital commitments with third parties in furtherance of our pursuit of a potential therapy for COVID-19, the disease caused by the virus SARS-CoV-2, and we may be unable to secure sufficient capital, market demand or manufacturing capacity to successfully develop and commercialize a therapy that treats the virus in a timely manner, if at all.
Our future success is substantially dependent on the successful clinical development, regulatory approval and commercialization of EUA product(s) and our product candidates in a timely manner. If we are not able to obtain required regulatory approvals and marketing authorizations, we will not be able to commercialize our product candidates and our ability to generate product revenue will be adversely affected.
We are a party to strategic collaboration and license agreements pursuant to which we are obligated to make substantial payments upon achievement of milestone events and, in certain cases, have relinquished important rights over the development and commercialization of certain current and future product candidates. We also intend to explore additional strategic collaborations, which may never materialize or may require that we relinquish rights to and control over the development and commercialization of our product candidates.
Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials and we cannot assure you that any ongoing, planned or future clinical trials will lead to results sufficient for the necessary regulatory approvals.
Clinical product development involves a lengthy and expensive process. We may incur additional costs and encounter substantial delays or difficulties in our clinical trials.
Our business could be materially adversely affected by the effects of health pandemics or epidemics, including the current COVID-19 pandemic and future outbreaks of the disease.
The market price of our common stock has been, and in the future, may be, volatile and fluctuate substantially, which could result in substantial losses for purchasers of our common stock.
We intend to rely on third parties to produce clinical and commercial supplies of our product candidates.
If we are unable to obtain and maintain patent protection for our product candidates and technology, or if the scope of the patent protection obtained is not sufficiently broad or robust, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to successfully commercialize our product candidates and technology may be adversely affected.
We are highly dependent on our key personnel, and if we are not able to retain these members of our management team or recruit and retain additional management, clinical and scientific personnel, our business will be harmed.

3


PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

VIR BIOTECHNOLOGY, INC.

Condensed Consolidated Balance Sheets

(in thousands, except share and per share data)

(unaudited)

 

 

 

September 30,
2021

 

 

December 31,
2020

 

ASSETS

 

 

 

 

 

 

CURRENT ASSETS:

 

 

 

 

 

 

Cash and cash equivalents

 

$

714,521

 

 

$

436,575

 

Short-term investments

 

 

55,560

 

 

 

300,286

 

Restricted cash and cash equivalents, current

 

 

6,112

 

 

 

7,993

 

Receivable from collaboration

 

 

93,003

 

 

 

 

Equity investments

 

 

169,369

 

 

 

 

Prepaid expenses and other current assets

 

 

27,772

 

 

 

27,511

 

Total current assets

 

 

1,066,337

 

 

 

772,365

 

Intangible assets, net

 

 

33,421

 

 

 

33,820

 

Goodwill

 

 

16,937

 

 

 

16,937

 

Property and equipment, net

 

 

26,610

 

 

 

17,946

 

Operating right-of-use assets

 

 

57,566

 

 

 

61,947

 

Restricted cash and cash equivalents, noncurrent

 

 

6,999

 

 

 

6,919

 

Other assets

 

 

2,343

 

 

 

8,827

 

TOTAL ASSETS

 

$

1,210,213

 

 

$

918,761

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

CURRENT LIABILITIES:

 

 

 

 

 

 

Accounts payable

 

$

4,225

 

 

$

5,077

 

Accrued and other liabilities

 

 

64,845

 

 

 

76,936

 

Deferred revenue, current portion

 

 

96,154

 

 

 

6,451

 

Contingent consideration, current portion

 

 

68,500

 

 

 

10,600

 

Total current liabilities

 

 

233,724

 

 

 

99,064

 

Deferred revenue, noncurrent

 

 

3,815

 

 

 

3,815

 

Operating lease liabilities, noncurrent

 

 

68,604

 

 

 

66,556

 

Contingent consideration, noncurrent

 

 

20,720

 

 

 

25,374

 

Deferred tax liability

 

 

3,253

 

 

 

3,253

 

Other long-term liabilities

 

 

3,823

 

 

 

3,847

 

TOTAL LIABILITIES

 

 

333,939

 

 

 

201,909

 

Commitments and contingencies (Note 8)

 

 

 

 

 

 

STOCKHOLDERS’ EQUITY:

 

 

 

 

 

 

Preferred stock, $0.0001 par value; 10,000,000 shares authorized as of September 30, 2021 and
   December 31, 2020;
no shares issued and outstanding as of September 30, 2021 and
   December 31, 2020

 

 

 

 

 

 

Common stock, $0.0001 par value; 300,000,000 shares authorized as of September 30, 2021 and
   December 31, 2020;
130,826,122 and 127,416,740 shares issued and outstanding as
   of September 30, 2021 and December 31, 2020, respectively

 

 

13

 

 

 

13

 

Additional paid-in capital

 

 

1,541,422

 

 

 

1,385,301

 

Accumulated other comprehensive loss

 

 

(1,307

)

 

 

(1,278

)

Accumulated deficit

 

 

(663,854

)

 

 

(667,184

)

TOTAL STOCKHOLDERS’ EQUITY

 

 

876,274

 

 

 

716,852

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

 

$

1,210,213

 

 

$

918,761

 

 

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

4


VIR BIOTECHNOLOGY, INC.

Condensed Consolidated Statements of Operations

(in thousands, except share and per share data)

(unaudited)

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

Collaboration revenue

 

$

102,398

 

 

$

 

 

$

107,731

 

 

$

 

Contract revenue

 

 

315

 

 

 

188

 

 

 

169,581

 

 

 

44,197

 

Grant revenue

 

 

903

 

 

 

1,740

 

 

 

5,356

 

 

 

7,690

 

License revenue from a related party

 

 

 

 

 

 

 

 

 

 

 

22,747

 

Total revenue

 

 

103,616

 

 

 

1,928

 

 

 

282,668

 

 

 

74,634

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Cost of revenue

 

 

7,836

 

 

 

 

 

 

8,988

 

 

 

 

Research and development

 

 

98,669

 

 

 

70,684

 

 

 

319,665

 

 

 

215,316

 

Selling, general and administrative

 

 

50,496

 

 

 

18,859

 

 

 

105,016

 

 

 

47,894

 

Total operating expenses

 

 

157,001

 

 

 

89,543

 

 

 

433,669

 

 

 

263,210

 

Loss from operations

 

 

(53,385

)

 

 

(87,615

)

 

 

(151,001

)

 

 

(188,576

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Change in fair value of equity investments

 

 

164,072

 

 

 

 

 

 

164,072

 

 

 

 

Interest income

 

 

11

 

 

 

412

 

 

 

272

 

 

 

2,548

 

Other income (expense), net

 

 

64

 

 

 

2,616

 

 

 

(9,430

)

 

 

(6,904

)

Total other income (expense)

 

 

164,147

 

 

 

3,028

 

 

 

154,914

 

 

 

(4,356

)

Income (loss) before provision for income taxes

 

 

110,762

 

 

 

(84,587

)

 

 

3,913

 

 

 

(192,932

)

Provision for income taxes

 

 

(334

)

 

 

(22

)

 

 

(583

)

 

 

(84

)

Net income (loss)

 

$

110,428

 

 

$

(84,609

)

 

$

3,330

 

 

$

(193,016

)

Net income (loss) per share, basic

 

$

0.85

 

 

$

(0.67

)

 

$

0.03

 

 

$

(1.66

)

Net income (loss) per share, diluted

 

$

0.82

 

 

$

(0.67

)

 

$

0.02

 

 

$

(1.66

)

Weighted-average shares outstanding, basic

 

 

130,665,831

 

 

 

125,810,907

 

 

 

129,520,837

 

 

 

116,427,529

 

Weighted-average shares outstanding, diluted

 

 

133,854,419

 

 

 

125,810,907

 

 

 

133,318,979

 

 

 

116,427,529

 

 

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

5


VIR BIOTECHNOLOGY, INC.

Condensed Consolidated Statements of Comprehensive Income (Loss)

(in thousands)

(unaudited)

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Net income (loss)

 

$

110,428

 

 

$

(84,609

)

 

$

3,330

 

 

$

(193,016

)

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain (loss) on investments

 

 

13

 

 

 

(196

)

 

 

(71

)

 

 

99

 

Amortization of actuarial loss

 

 

14

 

 

 

6

 

 

 

42

 

 

 

17

 

Other comprehensive income (loss)

 

 

27

 

 

 

(190

)

 

 

(29

)

 

 

116

 

Comprehensive income (loss)

 

$

110,455

 

 

$

(84,799

)

 

$

3,301

 

 

$

(192,900

)

 

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

6


VIR BIOTECHNOLOGY, INC.

Condensed Consolidated Statements of Stockholders’ Equity

(in thousands, except share amounts)

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

Total

 

 

 

Common Stock

 

 

Paid-in

 

 

Comprehensive

 

 

Accumulated

 

 

Stockholders'

 

 

 

Share

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Equity

 

Balance at June 30, 2021

 

 

130,479,975

 

 

$

13

 

 

$

1,512,928

 

 

$

(1,334

)

 

$

(774,282

)

 

$

737,325

 

Issuance of common stock to settle a contingent consideration

 

 

42,737

 

 

 

 

 

 

1,860

 

 

 

 

 

 

 

 

 

1,860

 

Vesting of restricted common stock

 

 

1,852

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exercise of stock options

 

 

301,558

 

 

 

 

 

 

3,690

 

 

 

 

 

 

 

 

 

3,690

 

Stock-based compensation

 

 

 

 

 

 

 

 

22,944

 

 

 

 

 

 

 

 

 

22,944

 

Other comprehensive income

 

 

 

 

 

 

 

 

 

 

 

27

 

 

 

 

 

 

27

 

Net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

110,428

 

 

 

110,428

 

Balance at September 30, 2021

 

 

130,826,122

 

 

$

13

 

 

$

1,541,422

 

 

$

(1,307

)

 

$

(663,854

)

 

$

876,274

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

Total

 

 

 

Common Stock

 

 

Paid-in

 

 

Comprehensive

 

 

Accumulated

 

 

Stockholders'

 

 

 

Share

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Equity

 

Balance at June 30, 2020

 

 

117,727,086

 

 

$

12

 

 

$

1,040,988

 

 

$

(295

)

 

$

(476,926

)

 

$

563,779

 

Issuance of common stock in connection with a
  follow-on offering, net of issuance costs of $
21,786

 

 

8,214,285

 

 

 

1

 

 

 

323,213

 

 

 

 

 

 

 

 

 

323,214

 

Vesting of restricted common stock

 

 

561,255

 

 

 

 

 

 

427

 

 

 

 

 

 

 

 

 

427

 

Exercise of stock options

 

 

489,005

 

 

 

 

 

 

1,152

 

 

 

 

 

 

 

 

 

1,152

 

Stock-based compensation

 

 

 

 

 

 

 

 

8,582

 

 

 

 

 

 

 

 

 

8,582

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(190

)

 

 

 

 

 

(190

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(84,609

)

 

 

(84,609

)

Balance at September 30, 2020

 

 

126,991,631

 

 

$

13

 

 

$

1,374,362

 

 

$

(485

)

 

$

(561,535

)

 

$

812,355

 

 

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

7


VIR BIOTECHNOLOGY, INC.

Condensed Consolidated Statements of Stockholders’ Equity

(in thousands, except share amounts)

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

Total

 

 

 

Common Stock

 

 

Paid-in

 

 

Comprehensive

 

 

Accumulated

 

 

Stockholders'

 

 

 

Share

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Equity

 

Balance at December 31, 2020

 

 

127,416,740

 

 

$

13

 

 

$

1,385,301

 

 

$

(1,278

)

 

$

(667,184

)

 

$

716,852

 

Issuance of common stock in connection with a
  collaboration agreement

 

 

1,924,927

 

 

 

 

 

 

85,213

 

 

 

 

 

 

 

 

 

85,213

 

Issuance of common stock to settle a contingent consideration

 

 

42,737

 

 

 

 

 

 

1,860

 

 

 

 

 

 

 

 

 

1,860

 

Vesting of restricted common stock

 

 

89,261

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exercise of stock options

 

 

1,352,457

 

 

 

 

 

 

9,635

 

 

 

 

 

 

 

 

 

9,635

 

Stock-based compensation

 

 

 

 

 

 

 

 

59,413

 

 

 

 

 

 

 

 

 

59,413

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(29

)

 

 

 

 

 

(29

)

Net income