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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 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, 2022

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: 001-34207

 

Dynavax Technologies Corporation

(Exact name of registrant as specified in its charter)

 

 

Delaware

 

33-0728374

(State or other jurisdiction of
incorporation or organization)

 

(IRS Employer
Identification No.)

2100 Powell Street, Suite 720

Emeryville, CA 94608

(510) 848-5100

(Address, including Zip Code, and telephone number, including area code, of the registrant’s principal executive offices)

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, $0.001 par value

DVAX

The Nasdaq Stock Market LLC

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 registration 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, a 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 Act). Yes ☐ No

As of November 1, 2022, the registrant had outstanding 127,584,879 shares of common stock.

 

 


 

INDEX

DYNAVAX TECHNOLOGIES CORPORATION

 

 

Page No.

PART I FINANCIAL INFORMATION

 

 

Item 1.

Financial Statements (unaudited)

4

 

Condensed Consolidated Balance Sheets as of September 30, 2022 and December 31, 2021

4

 

Condensed Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2022 and 2021

5

 

Condensed Consolidated Statements of Comprehensive Income (Loss) for the Three and Nine Months Ended September 30, 2022 and 2021

6

 

Condensed Consolidated Statements of Stockholders’ Equity for the Three and Nine Months Ended September 30, 2022 and 2021

7

 

Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2022 and 2021

8

 

Notes to Condensed Consolidated Financial Statements

9

Item 2.

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

30

Item 3.

Quantitative and Qualitative Disclosures about Market Risk

39

Item 4.

Controls and Procedures

39

PART II OTHER INFORMATION

 

Item 1.

Legal Proceedings

40

Item 1A.

Risk Factors

40

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

65

Item 3.

Defaults upon Senior Securities

65

Item 4.

Mine Safety Disclosures

65

Item 5.

Other Information

65

Item 6.

Exhibits

67

SIGNATURES

69

 

 

2


 

FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to a number of risks and uncertainties. All statements that are not historical facts are forward-looking statements, including statements about the direct and indirect impact of the ongoing COVID-19 global pandemic on our business and operations, including sales of HEPLISAV-B®, our ability to successfully commercialize HEPLISAV-B, CpG 1018 adjuvant or any future product, our anticipated market opportunity and level of sales of HEPLISAV-B and CpG 1018 adjuvant, our ability to manufacture sufficient supply of HEPLISAV-B to meet future demand, our business, collaboration and regulatory strategy, our ability to successfully support the development, manufacture and commercialization of other vaccines containing our CpG 1018 adjuvant, including any current or potential vaccine or vaccine candidate for COVID-19 that stem from any of our collaborations, our ability to manufacture sufficient supply of CpG 1018 adjuvant to meet potential future demand in connection with new vaccines, including COVID-19 vaccines, our ability to advance our other product candidates, such as our Tdap, shingles and plague programs, and to otherwise develop and expand our clinical research pipeline, meet regulatory requirements, including post-marketing obligations and commitments, uncertainty regarding our capital needs and future operating results and profitability, anticipated sources of funds, liquidity and cash needs, as well as our plans, objectives, strategies, expectations and intentions. These statements appear throughout this Quarterly Report on Form 10-Q and can be identified by the use of forward-looking language such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “future,” or “intend,” or the negative of these terms or other variations or comparable terminology.

Actual results may vary materially from those in our forward-looking statements as a result of various factors that are identified in “Item 1A—Risk Factors” and “Item 2—Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this document. No assurance can be given that the risk factors described in this Quarterly Report on Form 10-Q are all of the factors that could cause actual results to vary materially from the forward-looking statements. All forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q. Readers should not place undue reliance on these forward-looking statements and are cautioned that any such forward-looking statements are not guarantees of future performance. We assume no obligation to update any forward-looking statements.

This Quarterly Report on Form 10-Q includes trademarks and registered trademarks of Dynavax Technologies Corporation. Products or service names of other companies mentioned in this Quarterly Report on Form 10-Q may be trademarks or registered trademarks of their respective owners. References herein to “we,” “our,” “us,” “Dynavax” or the “Company” refer to Dynavax Technologies Corporation and its subsidiaries.

 

 

3


 

PART I. FINANCIAL INFORMATION

 

ITEM 1. FINANCIAL STATEMENTS

Dynavax Technologies Corporation

Condensed Consolidated Balance Sheets

(In thousands, except per share amounts)

 

 

September 30,

 

 

December 31,

 

 

2022

 

 

2021

 

 

(unaudited)

 

 

(Note 1)

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

$

198,576

 

 

$

436,189

 

Marketable securities available-for-sale

 

387,910

 

 

 

109,761

 

Accounts receivables, net

 

129,772

 

 

 

116,216

 

Other receivables

 

1,346

 

 

 

15,600

 

Inventories, net

 

102,609

 

 

 

61,335

 

Prepaid manufacturing

 

12,727

 

 

 

159,655

 

Prepaid expenses and other current assets

 

100,004

 

 

 

73,764

 

Total current assets

 

932,944

 

 

 

972,520

 

Property and equipment, net

 

35,352

 

 

 

35,020

 

Operating lease right-of-use assets

 

25,680

 

 

 

25,964

 

Goodwill

 

1,835

 

 

 

2,125

 

Restricted cash

 

189

 

 

 

219

 

Other assets

 

3,337

 

 

 

3,398

 

Total assets

$

999,337

 

 

$

1,039,246

 

Liabilities and stockholders’ equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

$

3,050

 

 

$

2,600

 

Accrued research and development

 

4,300

 

 

 

4,688

 

CEPI accrual (Note 6)

 

107,738

 

 

 

128,848

 

Accrued liabilities

 

38,209

 

 

 

49,796

 

Warrant liability

 

-

 

 

 

18,016

 

Deferred revenue

 

87,395

 

 

 

349,864

 

Other current liabilities

 

3,388

 

 

 

2,590

 

Total current liabilities

 

244,080

 

 

 

556,402

 

Convertible Notes, net of debt discount of $4,197 and $5,010 at September 30, 2022, and December 31, 2021, respectively

 

221,303

 

 

 

220,490

 

Long-term portion of lease liabilities

 

33,127

 

 

 

34,316

 

Other long-term liabilities

 

251

 

 

 

5,664

 

Total liabilities

 

498,761

 

 

 

816,872

 

Commitments and contingencies (Note 5)

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

Common stock: $0.001 par value; 278,000 shares authorized at
September 30, 2022 and December 31, 2021;
127,581 shares and 122,945
   shares issued and outstanding at September 30, 2022 and December 31, 2021,
   respectively

 

127

 

 

 

123

 

Additional paid-in capital

 

1,501,639

 

 

 

1,441,868

 

Accumulated other comprehensive loss

 

(9,262

)

 

 

(2,266

)

Accumulated deficit

 

(991,928

)

 

 

(1,217,351

)

Total stockholders’ equity

 

500,576

 

 

 

222,374

 

Total liabilities and stockholders’ equity

$

999,337

 

 

$

1,039,246

 

 

See accompanying notes.

 

4


 

Dynavax Technologies Corporation

Condensed Consolidated Statements of Operations

(In thousands, except per share amounts)

(Unaudited)

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

Product revenue, net

 

$

163,815

 

 

$

106,996

 

 

$

531,462

 

 

$

242,558

 

Other revenue

 

 

3,920

 

 

 

1,274

 

 

 

6,729

 

 

 

1,814

 

Total revenues

 

 

167,735

 

 

 

108,270

 

 

 

538,191

 

 

 

244,372

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Cost of sales - product

 

 

61,334

 

 

 

60,090

 

 

 

184,665

 

 

 

99,560

 

Research and development

 

 

12,962

 

 

 

6,186

 

 

 

33,746

 

 

 

21,111

 

Selling, general and administrative

 

 

32,042

 

 

 

26,926

 

 

 

100,393

 

 

 

70,932

 

Gain on sale of assets (Note 5)

 

 

-

 

 

 

(1,000

)

 

 

(1,000

)

 

 

(1,000

)

Total operating expenses

 

 

106,338

 

 

 

92,202

 

 

 

317,804

 

 

 

190,603

 

Income from operations

 

 

61,397

 

 

 

16,068

 

 

 

220,387

 

 

 

53,769

 

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

2,562

 

 

 

39

 

 

 

3,588

 

 

 

134

 

Interest expense

 

 

(1,685

)

 

 

(1,676

)

 

 

(5,048

)

 

 

(9,497

)

Sublease income

 

 

2,026

 

 

 

2,022

 

 

 

5,660

 

 

 

5,714

 

Loss on debt extinguishment

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(5,232

)

Change in fair value of warrant liability (Note 10)

 

 

-

 

 

 

(45,121

)

 

 

1,801

 

 

 

(68,576

)

Other

 

 

(208

)

 

 

238

 

 

 

(63

)

 

 

622

 

Net income (loss) before income taxes

 

 

64,092

 

 

 

(28,430

)

 

 

226,325

 

 

 

(23,066

)

Provision for income taxes

 

 

(283

)

 

 

-

 

 

 

(902

)

 

 

-

 

Net income (loss)

 

$

63,809

 

 

$

(28,430

)

 

$

225,423

 

 

$

(23,066

)

Net income (loss) per share attributable to common stockholders:

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

0.50

 

 

$

(0.24

)

 

$

1.79

 

 

$

(0.20

)

Diluted

 

$

0.43

 

 

$

(0.24

)

 

$

1.51

 

 

$

(0.20

)

Weighted-average shares used in computing net income (loss) per share attributable to common stockholders:

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

127,062

 

 

 

116,903

 

 

 

125,997

 

 

 

114,540

 

Diluted

 

 

151,538

 

 

 

116,903

 

 

 

150,433

 

 

 

114,540

 

See accompanying notes.

 

5


 

Condensed Consolidated Statements of Comprehensive Income (Loss)

(In thousands)

(Unaudited)

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Net income (loss)

 

$

63,809

 

 

$

(28,430

)

 

$

225,423

 

 

$

(23,066

)

Other comprehensive income (loss), net of tax:

 

 

 

 

 

 

 

 

 

 

 

 

Change in unrealized gain (loss) on marketable securities available-for-sale

 

 

(395

)

 

 

(18

)

 

 

(2,296

)

 

 

11

 

Foreign currency translation adjustments

 

 

(2,307

)

 

 

(797

)

 

 

(4,700

)

 

 

(1,812

)

Total other comprehensive (loss)

 

 

(2,702

)

 

 

(815

)

 

 

(6,996

)

 

 

(1,801

)

Total comprehensive income (loss)

 

$

61,107

 

 

$

(29,245

)

 

$

218,427

 

 

$

(24,867

)

 

See accompanying notes.

 

 

 

6


 

Dynavax Technologies Corporation

Condensed Consolidated Statements of Stockholders’ Equity

(In thousands)

(Unaudited)

 

 

 

Common Stock

 

 

Preferred Stock

 

 

Additional
Paid-In

 

 

Accumulated
Other
Comprehensive

 

 

Accumulated

 

 

Total
Stockholders'

 

Three Months Ended September 30, 2022

 

Shares

 

 

Par Amount

 

 

Shares

 

 

Par Amount

 

 

Capital

 

 

(Loss) Income

 

 

Deficit

 

 

Equity

 

Balances at June 30, 2022

 

 

126,439

 

 

$

126

 

 

 

-

 

 

$

-

 

 

$

1,484,970

 

 

$

(6,560

)

 

$

(1,055,737

)

 

$

422,799

 

Issuance of common stock upon exercise of stock options and/or release of restricted stock awards, net

 

 

1,070

 

 

 

1

 

 

 

-

 

 

 

-

 

 

 

7,336

 

 

 

-

 

 

 

-

 

 

 

7,337

 

Issuance of common stock under Employee Stock Purchase Plan

 

 

72

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

720

 

 

 

-

 

 

 

-

 

 

 

720

 

Stock compensation expense

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

8,613

 

 

 

-

 

 

 

-

 

 

 

8,613

 

Total other comprehensive loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(2,702

)

 

 

-

 

 

 

(2,702

)

Net income

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

63,809

 

 

 

63,809

 

Balances at September 30, 2022

 

 

127,581

 

 

$

127

 

 

 

-

 

 

$

-

 

 

$

1,501,639

 

 

$

(9,262

)

 

$

(991,928

)

 

$

500,576

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Nine Months Ended September 30, 2022

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balances at December 31, 2021

 

 

122,945

 

 

$

123

 

 

 

-

 

 

$

-

 

 

$

1,441,868

 

 

$

(2,266

)

 

$

(1,217,351

)

 

$

222,374

 

Issuance of common stock upon exercise of warrants

 

 

1,879

 

 

 

2

 

 

 

-

 

 

 

-

 

 

 

24,668

 

 

 

-

 

 

 

-

 

 

 

24,670

 

Issuance of common stock upon exercise of stock options and/or release of restricted stock awards, net

 

 

2,603

 

 

 

2

 

 

 

-

 

 

 

-

 

 

 

9,485

 

 

 

-

 

 

 

-

 

 

 

9,487

 

Issuance of common stock under Employee Stock Purchase Plan

 

 

154

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

1,430

 

 

 

-

 

 

 

-

 

 

 

1,430

 

Stock compensation expense

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

24,188

 

 

 

-

 

 

 

-

 

 

 

24,188

 

Total other comprehensive loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(6,996

)

 

 

-

 

 

 

(6,996

)

Net income

 

 

-

 

 

 

-

 

 

 

-