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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, 2020

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 6, 2020, the registrant had 127,388,620 shares of common stock, $0.0001 par value per share, outstanding.

 

 

 


Table of Contents

 

 

 

Page

PART I.

FINANCIAL INFORMATION

 

Item 1.

Financial Statements (unaudited)

3

 

Condensed Consolidated Balance Sheets as of September 30, 2020 (unaudited) and December 31, 2019

3

 

Condensed Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2020 and 2019 (unaudited)

4

 

Condensed Consolidated Statements of Comprehensive Loss for the Three and Nine Months Ended September 30, 2020 and 2019 (unaudited)

5

 

Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit) for the Three and Nine Months Ended September 30, 2020 and 2019 (unaudited)

6

 

Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2020 and 2019 (unaudited)

8

 

Notes to Unaudited Condensed Consolidated Financial Statements

9

Item 2.

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

35

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

46

Item 4.

Controls and Procedures

47

PART II.

OTHER INFORMATION

 

Item 1.

Legal Proceedings

48

Item 1A.

Risk Factors

48

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

96

Item 3.

Defaults Upon Senior Securities

96

Item 4.

Mine Safety Disclosures

96

Item 5.

Other Information

96

Item 6.

Exhibits

97

Signatures

98

 


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


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,

2020

 

 

December 31,

2019

 

ASSETS

 

 

 

 

 

 

 

 

CURRENT ASSETS:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

462,521

 

 

$

109,335

 

Short-term investments

 

 

364,074

 

 

 

274,101

 

Restricted cash and cash equivalents, current

 

 

9,363

 

 

 

6,181

 

Prepaid expenses and other current assets

 

 

13,614

 

 

 

13,378

 

Total current assets

 

 

849,572

 

 

 

402,995

 

Intangible assets, net

 

 

33,944

 

 

 

35,694

 

Goodwill

 

 

16,937

 

 

 

16,937

 

Property and equipment, net

 

 

16,948

 

 

 

16,308

 

Operating right-of-use assets

 

 

14,762

 

 

 

 

Restricted cash and cash equivalents, noncurrent

 

 

1,201

 

 

 

7,300

 

Long-term investments

 

 

 

 

 

24,290

 

Other assets

 

 

9,895

 

 

 

8,547

 

TOTAL ASSETS

 

$

943,259

 

 

$

512,071

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

CURRENT LIABILITIES:

 

 

 

 

 

 

 

 

Accounts payable

 

 

6,796

 

 

$

5,881

 

Accrued and other liabilities

 

 

44,339

 

 

 

26,495

 

Deferred revenue, current portion

 

 

5,563

 

 

 

6,181

 

Contingent consideration, current portion

 

 

20,300

 

 

 

8,200

 

Derivative liability

 

 

 

 

 

12,449

 

Total current liabilities

 

 

76,998

 

 

 

59,206

 

Deferred revenue, noncurrent

 

 

3,815

 

 

 

12,670

 

Operating lease liabilities, noncurrent

 

 

12,092

 

 

 

 

Contingent consideration, noncurrent

 

 

31,712

 

 

 

9,380

 

Deferred tax liability

 

 

3,305

 

 

 

3,305

 

Other long-term liabilities

 

 

2,982

 

 

 

3,568

 

TOTAL LIABILITIES

 

 

130,904

 

 

 

88,129

 

Commitments and contingencies (Note 9)

 

 

 

 

 

 

 

 

STOCKHOLDERS’ EQUITY:

 

 

 

 

 

 

 

 

Preferred stock, $0.0001 par value; 10,000,000 shares authorized as of September 30,

   2020 and December 31, 2019; no shares issued and outstanding as of September 30,

   2020 and December 31, 2019

 

 

 

 

 

 

Common stock, $0.0001 par value; 300,000,000 shares authorized as of September 30,

   2020 and December 31, 2019; 126,991,631 and 107,648,925 shares issued and

   outstanding as of September 30, 2020 and December 31, 2019, respectively

 

 

13

 

 

 

11

 

Additional paid-in capital

 

 

1,374,362

 

 

 

793,051

 

Accumulated other comprehensive loss

 

 

(485

)

 

 

(601

)

Accumulated deficit

 

 

(561,535

)

 

 

(368,519

)

TOTAL STOCKHOLDERS’ EQUITY

 

 

812,355

 

 

 

423,942

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

 

$

943,259

 

 

$

512,071

 

 

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

3


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,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Grant revenue

 

$

1,740

 

 

$

1,166

 

 

$

7,690

 

 

$

6,771

 

License revenue from a related party

 

 

 

 

 

 

 

 

22,747

 

 

 

 

Contract revenue

 

 

188

 

 

 

237

 

 

 

44,197

 

 

 

340

 

Total revenue

 

 

1,928

 

 

 

1,403

 

 

 

74,634

 

 

 

7,111

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

70,684

 

 

 

39,863

 

 

 

215,316

 

 

 

95,541

 

General and administrative

 

 

18,859

 

 

 

9,220

 

 

 

47,894

 

 

 

25,790

 

Total operating expenses

 

 

89,543

 

 

 

49,083

 

 

 

263,210

 

 

 

121,331

 

Loss from operations

 

 

(87,615

)

 

 

(47,680

)

 

 

(188,576

)

 

 

(114,220

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

412

 

 

 

2,012

 

 

 

2,548

 

 

 

6,564

 

Other income (expense), net

 

 

2,616

 

 

 

(2,659

)

 

 

(6,904

)

 

 

(3,251

)

Total other income (expense)

 

 

3,028

 

 

 

(647

)

 

 

(4,356

)

 

 

3,313

 

Loss before benefit from (provision for) income taxes

 

 

(84,587

)

 

 

(48,327

)

 

 

(192,932

)

 

 

(110,907

)

Benefit from (provision for) income taxes

 

 

(22

)

 

 

13

 

 

 

(84

)

 

 

(5

)

Net loss

 

$

(84,609

)

 

$

(48,314

)

 

$

(193,016

)

 

$

(110,912

)

Net loss per share, basic and diluted

 

$

(0.67

)

 

$

(4.60

)

 

$

(1.66

)

 

$

(11.53

)

Weighted-average shares outstanding, basic and diluted

 

 

125,810,907

 

 

 

10,500,848

 

 

 

116,427,529

 

 

 

9,615,379

 

 

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

4


VIR BIOTECHNOLOGY, INC.

Condensed Consolidated Statements of Comprehensive Loss

(in thousands)

(unaudited)

 

 

 

Three Months Ended

September 30,

 

 

Nine Months Ended

September 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Net loss

 

$

(84,609

)

 

$

(48,314

)

 

$

(193,016

)

 

$

(110,912

)

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain (loss) on investments

 

 

(196

)

 

 

(159

)

 

99

 

 

 

95

 

Amortization of actuarial loss

 

 

6

 

 

 

 

 

17

 

 

 

 

Other comprehensive income (loss)

 

 

(190

)

 

 

(159

)

 

 

116

 

 

 

95

 

Comprehensive loss

 

$

(84,799

)

 

$

(48,473

)

 

$

(192,900

)

 

$

(110,817

)

 

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

 

 

5


VIR BIOTECHNOLOGY, INC.

Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit)

(in thousands, except share amounts)

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

 

Total

 

 

 

Convertible Preferred Stock

 

 

 

Common Stock

 

 

Paid-in

 

 

Comprehensive

 

 

Accumulated

 

 

Stockholders'

 

 

 

Share

 

 

Amount

 

 

 

Share

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Equity (Deficit)

 

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

 

Total

 

 

 

Convertible Preferred Stock

 

 

 

Common Stock

 

 

Paid-in

 

 

Comprehensive

 

 

Accumulated

 

 

Stockholders'

 

 

 

Share

 

 

Amount

 

 

 

Share

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Equity (Deficit)

 

Balance at June 30, 2019

 

 

88,112,733

 

 

$

636,612

 

 

 

 

9,722,838

 

 

$

1

 

 

$

19,226

 

 

$

240

 

 

$

(256,434

)

 

$

(236,967

)

Issuance of common stock in connection with a license agreement

 

 

 

 

 

 

 

 

 

38,888

 

 

 

 

 

 

617

 

 

 

 

 

 

 

 

 

617

 

Repayment of promissory notes, net of unvested common stock

 

 

 

 

 

 

 

 

 

1,390,925

 

 

 

 

 

 

1,355

 

 

 

 

 

 

 

 

 

1,355

 

Vesting of restricted common stock

 

 

 

 

 

 

 

 

 

337,075

 

 

 

 

 

 

119

 

 

 

 

 

 

 

 

 

119

 

Exercise of stock options

 

 

 

 

 

 

 

 

 

238,506

 

 

 

 

 

 

364

 

 

 

 

 

 

 

 

 

364

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,188

 

 

 

 

 

 

 

 

 

2,188

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(159

)

 

 

 

 

 

(159

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(48,314

)

 

 

(48,314

)

Balance at September 30, 2019

 

 

88,112,733

 

 

$

636,612

 

 

 

 

11,728,232

 

 

$

1

 

 

$

23,869

 

 

$

81

 

 

$

(304,748

)

 

$

(280,797

)

 

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

6


VIR BIOTECHNOLOGY, INC.

Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit)

(in thousands, except share amounts)

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

 

Total

 

 

 

Convertible Preferred Stock

 

 

 

Common Stock

 

 

Paid-in

 

 

Comprehensive

 

 

Accumulated

 

 

Stockholders'

 

 

 

Share

 

 

Amount