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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 June 30, 2024

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

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 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 August 1, 2024, the registrant had outstanding 131,044,383 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 June 30, 2024 and December 31, 2023

4

Condensed Consolidated Statements of Operations for the Three and Six Months Ended June 30, 2024 and 2023

5

 

Condensed Consolidated Statements of Comprehensive Income (Loss) for the Three and Six Months Ended June 30, 2024 and 2023

6

 

Condensed Consolidated Statements of Stockholders’ Equity for the Three and Six Months Ended June 30, 2024 and 2023

7

Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2024 and 2023

8

Notes to Unaudited Condensed Consolidated Financial Statements

9

Item 2.

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

24

Item 3.

Quantitative and Qualitative Disclosures about Market Risk

33

Item 4.

Controls and Procedures

33

PART II OTHER INFORMATION

 

Item 1.

Legal Proceedings

34

Item 1A.

Risk Factors

34

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

63

Item 3.

Defaults upon Senior Securities

63

Item 4.

Mine Safety Disclosures

63

Item 5.

Other Information

63

Item 6.

Exhibits

65

SIGNATURES

67

 

 

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 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 that stems 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, our ability to advance our other product candidates, such as our shingles, Tdap 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 (including our ability to collect on accounts receivables), anticipated future revenue, as well as our plans, objectives, strategies, expectations and intentions for our business. 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 after the date they are made.

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)

 

 

June 30,

 

 

December 31,

 

 

2024

 

 

2023

 

 

(unaudited)

 

 

(Note 1)

 

Assets

 

 

 

Current assets:

 

 

 

Cash and cash equivalents

$

112,501

 

 

$

150,279

 

Marketable securities available-for-sale

 

623,111

 

 

 

592,023

 

Accounts receivables, net of allowance for doubtful accounts of $12,313 at June 30, 2024 and December 31, 2023, respectively

 

61,654

 

 

 

40,607

 

Other receivables

 

976

 

 

 

3,926

 

Inventories

 

62,462

 

 

 

53,290

 

Prepaid expenses and other current assets

 

21,308

 

 

 

18,995

 

Total current assets

 

882,012

 

 

 

859,120

 

Property and equipment, net

 

36,105

 

 

 

37,297

 

Operating lease right-of-use assets

 

22,526

 

 

 

24,287

 

Goodwill

 

2,007

 

 

 

2,067

 

Other assets

 

73,671

 

 

 

74,325

 

Total assets

$

1,016,321

 

 

$

997,096

 

Liabilities and stockholders’ equity

 

 

 

 

Current liabilities:

 

 

 

 

Accounts payable

$

4,555

 

 

$

5,245

 

Accrued research and development

 

4,581

 

 

 

2,982

 

Accrued liabilities

 

48,488

 

 

 

49,448

 

Other current liabilities

 

4,568

 

 

 

4,520

 

Total current liabilities

 

62,192

 

 

 

62,195

 

Convertible Notes, net of debt discount of $2,228 and $2,802 at June 30, 2024 and December 31, 2023, respectively (Note 7)

 

223,272

 

 

 

222,698

 

Long-term portion of lease liabilities

 

27,473

 

 

 

29,720

 

CEPI accrual long-term (Note 6)

 

60,337

 

 

 

60,337

 

Other long-term liabilities

 

198

 

 

 

74

 

Total liabilities

 

373,472

 

 

 

375,024

 

Commitments and contingencies (Note 5)

 

 

 

 

Stockholders’ equity:

 

 

 

 

Preferred stock: $0.001 par value, 5,000 shares authorized at
  June 30, 2024 and December 31, 2023;
zero shares outstanding at
  June 30, 2024 and December 31, 2023

 

-

 

 

 

-

 

Common stock: $0.001 par value, 278,000 shares authorized at
  June 30, 2024 and December 31, 2023;
130,984 shares and 129,530
   shares issued and outstanding at June 30, 2024 and December 31, 2023,
   respectively

 

131

 

 

 

130

 

Additional paid-in capital

 

1,575,548

 

 

 

1,554,634

 

Accumulated other comprehensive loss

 

(4,911

)

 

 

(2,108

)

Accumulated deficit

 

(927,919

)

 

 

(930,584

)

Total stockholders’ equity

 

642,849

 

 

 

622,072

 

Total liabilities and stockholders’ equity

$

1,016,321

 

 

$

997,096

 

 

See accompanying notes.

 

4


 

Dynavax Technologies Corporation

Condensed Consolidated Statements of Operations

(In thousands, except per share amounts)

(Unaudited)

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

Product revenue, net

 

$

70,188

 

 

$

56,440

 

 

$

118,032

 

 

$

99,891

 

Other revenue

 

 

3,607

 

 

 

3,809

 

 

 

6,552

 

 

 

7,283

 

Total revenues

 

 

73,795

 

 

 

60,249

 

 

 

124,584

 

 

 

107,174

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Cost of sales - product

 

 

11,985

 

 

 

13,537

 

 

 

22,952

 

 

 

28,249

 

Research and development

 

 

14,950

 

 

 

13,046

 

 

 

28,478

 

 

 

26,651

 

Selling, general and administrative

 

 

41,662

 

 

 

37,071

 

 

 

85,727

 

 

 

73,614

 

Bad debt expense

 

 

-

 

 

 

-

 

 

 

-

 

 

 

12,313

 

Total operating expenses

 

 

68,597

 

 

 

63,654

 

 

 

137,157

 

 

 

140,827

 

Income (loss) from operations

 

 

5,198

 

 

 

(3,405

)

 

 

(12,573

)

 

 

(33,653

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

9,201

 

 

 

7,378

 

 

 

18,668

 

 

 

13,975

 

Interest expense

 

 

(1,698

)

 

 

(1,688

)

 

 

(3,393

)

 

 

(3,374

)

Sublease income (Note 5)

 

 

2,205

 

 

 

1,993

 

 

 

603

 

 

 

3,591

 

Other

 

 

-

 

 

 

(71

)

 

 

103

 

 

 

(48

)

Net income (loss) before income taxes

 

 

14,906

 

 

 

4,207

 

 

 

3,408

 

 

 

(19,509

)

Provision for income taxes

 

 

(3,520

)

 

 

(776

)

 

 

(743

)

 

 

(1,392

)

Net income (loss)

 

$

11,386

 

 

$

3,431

 

 

$

2,665

 

 

$

(20,901

)

Net income (loss) per share attributable to common stockholders

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

0.09

 

 

$

0.03

 

 

$

0.02

 

 

$

(0.16

)

Diluted

 

$

0.08

 

 

$

0.03

 

 

$

0.02

 

 

$

(0.16

)

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

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

130,916

 

 

 

128,625

 

 

 

130,551

 

 

 

128,275

 

Diluted

 

 

154,468

 

 

 

152,142

 

 

 

133,582

 

 

 

128,275

 

See accompanying notes.

 

5


 

Condensed Consolidated Statements of Comprehensive Income (Loss)

(In thousands)

(Unaudited)

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

 

Net income (loss)

 

$

11,386

 

 

$

3,431

 

 

$

2,665

 

 

$

(20,901

)

 

Other comprehensive (loss) income, net of tax:

 

 

 

 

 

 

 

 

 

 

 

 

 

Change in unrealized loss on marketable securities available-for-sale

 

 

(289

)

 

 

(1,197

)

 

 

(1,746

)

 

 

(531

)

 

Cumulative foreign currency translation adjustments

 

 

(249

)

 

 

25

 

 

 

(1,057

)

 

 

597

 

 

Total other comprehensive (loss) income

 

 

(538

)

 

 

(1,172

)

 

 

(2,803

)

 

 

66

 

 

Total comprehensive income (loss)

 

$

10,848

 

 

$

2,259

 

 

$

(138

)

 

$

(20,835

)

 

 

See accompanying notes.

 

 

 

6


 

Dynavax Technologies Corporation

Condensed Consolidated Statements of Stockholders’ Equity

(In thousands)

(Unaudited)

 

 

 

Common Stock

 

 

Preferred Stock

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended June 30, 2024

 

Shares

 

 

Par Amount

 

 

Shares

 

 

Par Amount

 

 

Additional
Paid-In Capital

 

 

Accumulated
Other
Comprehensive Loss

 

 

Accumulated Deficit

 

 

Total
Stockholders' Equity

 

Balances at March 31, 2024

 

 

130,859

 

 

$

131

 

 

 

-

 

 

$

-

 

 

$

1,562,027

 

 

$

(4,373

)

 

$

(939,305

)

 

$

618,480

 

Issuance of common stock upon exercise of stock options

 

 

54

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

419

 

 

 

-

 

 

 

-

 

 

 

419

 

Issuance of common stock upon release of restricted stock awards, net of statutory tax withholdings

 

 

71

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(416

)

 

 

-

 

 

 

-

 

 

 

(416

)

Stock compensation expense

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

13,518

 

 

 

-

 

 

 

-

 

 

 

13,518

 

Total other comprehensive loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(538

)

 

 

-

 

 

 

(538

)

Net income

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

11,386

 

 

 

11,386

 

Balances at June 30, 2024

 

 

130,984

 

 

$

131

 

 

 

-

 

 

$

-

 

 

$

1,575,548

 

 

$

(4,911

)

 

$

(927,919

)

 

$

642,849

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Six Months Ended June 30, 2024

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balances at December 31, 2023

 

 

129,530

 

 

$

130

 

 

 

-

 

 

$

-

 

 

$

1,554,634

 

 

$

(2,108

)

 

$

(930,584

)

 

$

622,072

 

Issuance of common stock upon exercise of stock options

 

 

294

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

2,054

 

 

 

-

 

 

 

-

 

 

 

2,054

 

Issuance of common stock upon release of restricted stock awards, net of statutory tax withholdings

 

 

1,066

 

 

 

1

 

 

 

-

 

 

 

-

 

 

 

(8,576

)

 

 

-

 

 

 

-

 

 

 

(8,575

)

Issuance of common stock under Employee Stock Purchase Plan

 

 

94

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

904

 

 

 

-

 

 

 

-

 

 

 

904

 

Stock compensation expense

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

26,532

 

 

 

-

 

 

 

-

 

 

 

26,532

 

Total other comprehensive loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(2,803

)

 

 

-

 

 

 

(2,803

)

Net income

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

2,665

 

 

 

2,665

 

Balances at June 30, 2024

 

 

130,984

 

 

$

131

 

 

 

-

 

 

$

-

 

 

$

1,575,548

 

 

$

(4,911

)

 

$

(927,919

)

 

$

642,849

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common Stock

 

 

Preferred Stock

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended June 30, 2023

 

Shares

 

 

Par Amount

 

 

Shares

 

 

Par Amount

 

 

Additional
Paid-In Capital

 

 

Accumulated
Other
Comprehensive (Loss) Income

 

 

Accumulated Deficit

 

 

Total
Stockholders' Equity

 

Balances at March 31, 2023

 

 

128,472

 

 

$

128

 

 

 

-

 

 

$

-

 

 

$

1,516,331

 

 

$

(4,200

)

 

$

(948,527

)

 

$

563,732

 

Issuance of common stock upon exercise of stock options

 

 

203

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

1,378

 

 

 

-

 

 

 

-

 

 

 

1,378

 

Issuance of common stock upon release of restricted stock awards, net of statutory tax withholdings

 

 

104

 

 

 

1

 

 

 

-

 

 

 

-

 

 

 

(727

)

 

 

-

 

 

 

-

 

 

 

(726

)

Stock compensation expense

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

10,562

 

 

 

-

 

 

 

-

 

 

 

10,562

 

Total other comprehensive income

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(1,172

)

 

 

-

 

 

 

(1,172

)

Net income

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

3,431

 

 

 

3,431

 

Balances at June 30, 2023

 

 

128,779

 

 

$

129

 

 

 

-

 

 

$

-

 

 

$

1,527,544

 

 

$

(5,372

)

 

$

(945,096

)

 

$

577,205

 

Six Months Ended June 30, 2023

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balances at December 31, 2022

 

 

127,604

 

 

$

128

 

 

 

-

 

 

$

-

 

 

$

1,510,518

 

 

$

(5,438

)

 

$

(924,195

)

 

$

581,013

 

Issuance of common stock upon exercise of stock options

 

 

244

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

1,617

 

 

 

-

 

 

 

-

 

 

 

1,617

 

Issuance of common stock upon release of restricted stock awards, net of statutory tax withholdings

 

 

850

 

 

 

1

 

 

 

-

 

 

 

-

 

 

 

(5,964

)

 

 

-

 

 

 

-

 

 

 

(5,963

)

Issuance of common stock under Employee Stock Purchase Plan

 

 

81

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

777

 

 

 

-

 

 

 

-

 

 

 

777

 

Stock compensation expense

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

20,596

 

 

 

-

 

 

 

-

 

 

 

20,596

 

Total other comprehensive income

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

66

 

 

 

-

 

 

 

66

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(20,901

)

 

 

(20,901

)

Balances at June 30, 2023

 

 

128,779

 

 

$

129

 

 

 

-

 

 

$

-

 

 

$

1,527,544

 

 

$

(5,372

)

 

$

(945,096

)

 

$

577,205

 

 

See accompanying notes.

 

 

 

7


 

Dynavax Technologies Corporation

Condensed Consolidated Statements of Cash Flows

(In thousands)

(Unaudited)

 

 

Six Months Ended June 30,

 

2024

 

 

2023

 

Operating activities

 

 

 

 

 

Net income (loss)

$

2,665

 

 

$

(20,901

)

Adjustments to reconcile net income (loss) to net cash (used in) provided by operating activities:

 

 

 

 

 

Depreciation and amortization

 

2,259

 

 

 

2,113

 

Amortization of right-of-use assets

 

1,668

 

 

 

1,335

 

Inventory write off

 

1,264

 

 

 

-

 

Sublease termination loss (Note 5)

 

4,765

 

 

 

-

 

Accretion of discounts on marketable securities

 

(8,465

)

 

 

(7,263

)

Stock-based compensation expense

 

26,532

 

 

 

20,596

 

Bad debt expense (Note 6)

 

-

 

 

 

12,313

 

Non-cash interest expense

 

574

 

 

 

556

 

Changes in operating assets and liabilities:

 

 

 

 

 

Accounts and other receivables, net

 

(18,097

)

 

 

42,448

 

Inventories

 

(10,436

)

 

 

6,358

 

Prepaid expenses and other current assets

 

(6,290

)

 

 

(3,172

)

Other assets

 

(101

)

 

 

703

 

Accounts payable

 

(569

)

 

 

(151

)

Lease liabilities

 

(2,109

)

 

 

(1,679

)

Accrued and other liabilities

 

374

 

 

 

2,412

 

Net cash (used in) provided by operating activities

 

(5,966

)

 

 

55,668

 

Investing activities

 

 

 

 

 

Purchases of marketable securities

 

(326,121

)

 

 

(259,531

)

Proceeds from maturities and redemption of marketable securities

 

301,713

 

 

 

233,953

 

Purchases of property and equipment, net

 

(1,528

)

 

 

(2,034

)

Net cash used in investing activities

 

(25,936

)

 

 

(27,612

)

Financing activities

 

 

 

 

 

Proceeds from exercise of stock options

 

2,054

 

 

 

1,617

 

Proceeds from Employee Stock Purchase Plan

 

904

 

 

 

777

 

Payments for taxes related to net share settlement of restricted stock units

 

(8,576

)

 

 

(5,778

)

Net cash used in financing activities

 

(5,618

)

 

 

(3,384

)

Effect of exchange rate changes on cash and cash equivalents, and restricted cash

 

(265

)

 

 

150

 

Net (decrease) increase in cash and cash equivalents, and restricted cash

 

(37,785

)

 

 

24,822

 

Cash and cash equivalents, and restricted cash at beginning of period

 

150,556

 

 

 

202,211

 

Cash and cash equivalents, and restricted cash at end of period

$

112,771

 

 

$

227,033

 

Supplemental disclosure of cash flow information

 

 

 

 

 

Cash paid during the period for income taxes

$

2,963

 

 

$

710

 

Cash paid during the period for interest

$

2,819

 

 

$

2,819

 

Reclassification of contract asset from other current assets to other assets

$

-

 

 

$

71,307

 

Reclassification of CEPI accrual to CEPI accrual long-term

$

-

 

 

$

(60,337

)

Advance Payments forgiven per CEPI-Bio E Assignment Agreement (Note 6)

$

-

 

 

$

(47,401

)

Non-cash investing and financing activities:

 

 

 

 

 

Purchases of property and equipment, not yet paid

$

574

 

 

$

540

 

Right-of-use assets obtained in exchange of operating lease liabilities

$

-

 

 

$

901

 

 

See accompanying notes.

 

8


 

Dynavax Technologies Corporation

Notes to Condensed Consolidated Financial Statements

(Unaudited)

 

1. Organization

Dynavax Technologies Corporation (“we,” “our,” “us,” “Dynavax” or the “Company”) is a commercial stage biopharmaceutical company developing and commercializing innovative vaccines to help protect the world against infectious diseases. Our first marketed product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted] is approved in the United States, the European Union and Great Britain for the prevention of infection caused by all known subtypes of hepatitis B virus in adults aged 18 years and older. In May 2022, we commenced commercial shipments of HEPLISAV-B in Germany.

We are advancing a pipeline of differentiated product candidates that leverage our CpG 1018® adjuvant, the adjuvant used in HEPLISAV-B, to develop improved vaccines in indications with unmet medical needs. These programs include vaccine candidates under development for shingles and Tdap, and a plague vaccine candidate program in collaboration with and fully funded by the U.S. Department of Defense ("DoD").

Additionally, we manufacture and have supplied in the past CpG 1018 adjuvant, the adjuvant used in HEPLISAV-B, through both commercial supply agreements, and through preclinical and clinical research collaborations with third-party organizations.

Basis of Presentation

Our accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and pursuant to the instructions to Form 10-Q and Article 10 of Regulation S-X. In our opinion, these unaudited condensed consolidated financial statements include all adjustments, consisting of normal recurring adjustments, which we consider necessary to present fairly our financial position and the results of our operations and cash flows. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP have been condensed or omitted. Interim-period results are not necessarily indicative of results of operations or cash flows to be expected for a full-year period or any other interim-period.

The condensed consolidated balance sheet as of December 31, 2023 has been derived from audited financial statements at that date, but excludes some disclosures required by GAAP for complete financial statements.

The unaudited condensed consolidated financial statements and these notes should be read in conjunction with the audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”).

The unaudited condensed consolidated financial statements include the accounts of Dynavax and our wholly-owned subsidiaries, Dynavax GmbH, located in Düsseldorf, Germany, Dynavax India LLP, located in India, and a branch of Dynavax registered in Italy. All significant intercompany accounts and transactions among these entities have been eliminated from the unaudited condensed consolidated financial statements. We operate in one business segment: discovery, development and commercialization of novel vaccines.

Use of Estimates

The preparation of unaudited condensed consolidated financial statements in conformity with GAAP requires management to make informed estimates and assumptions that may affect the amounts reported in the unaudited condensed consolidated financial statements and accompanying notes, including amounts of revenues and expenses during the reported periods. Management’s estimates are based on historical information available as of the date of the unaudited condensed consolidated financial statements and various other assumptions we believe are reasonable under the circumstances. On an ongoing basis, we evaluate our estimates, judgments and methodologies. Significant estimates and assumptions in the unaudited condensed consolidated financial statements include those related to revenue recognition; accounts receivable; useful lives of long-lived assets; valuation procedures for right-of-use assets and operating lease liabilities; valuation of inventory; research and development expenses; contingencies and share-based compensation. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results may differ materially from these estimates under different assumptions or conditions. Changes in estimates are reflected in reported results in the period in which they become known.

 

9


 

Recent Accounting Pronouncements

Accounting Standards Update 2016-13

In November 2023, the Financial Accounting Standards Board (“FASB”) issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which requires public entities to disclose information about their reportable segments’ significant expenses and other segment items on an interim and annual basis. Public entities with a single reportable segment are required to apply the disclosure requirements in ASU 2023-07, as well as all existing segment disclosures and reconciliation requirements in ASC 280 on an interim and annual basis. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and for interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. We are currently evaluating the impact of adopting ASU 2023-07.

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which requires public entities, on an annual basis, to provide disclosure of specific categories in the rate reconciliation, as well as disclosure of income taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. We are currently evaluating the impact of adopting ASU 2023-09.

 

2. Fair Value Measurements

We measure fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The accounting standard describes a fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value which are the following:

Level 1—Observable inputs, such as quoted prices in active markets for identical assets or liabilities;
Level 2—Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities; and
Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities; therefore, requiring an entity to develop its own valuation techniques and assumptions.

Assets and liabilities are classified based on the lowest level of input that is significant to the fair value measurements. We review the fair value hierarchy classification on a quarterly basis. Changes in the ability to observe valuation inputs may result in a reclassification of levels for certain assets or liabilities within the fair value hierarchy. There were no transfers between Level 1, 2 and 3 during the three and six months ended June 30, 2024.

The carrying amounts of cash equivalents, accounts and other receivables, accounts payable and accrued liabilities are considered reasonable estimates of their respective fair value because of their short-term nature.

 

10


 

Recurring Fair Value Measurements

The following table represents the fair value hierarchy for our financial assets (cash equivalents and marketable securities) measured at fair value on a recurring basis (in thousands):

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

June 30, 2024

 

 

 

 

 

 

 

 

 

 

 

Assets

 

 

 

 

 

 

 

 

 

 

 

Money market funds

$

96,611

 

 

$

-

 

 

$

-

 

 

$

96,611

 

U.S. treasuries

 

-

 

 

 

134,696

 

 

 

-

 

 

 

134,696

 

U.S. government agency securities

 

-

 

 

 

172,084

 

 

 

-

 

 

 

172,084

 

Corporate debt securities

 

-

 

 

 

323,954

 

 

 

-

 

 

 

323,954

 

Total assets

$

96,611

 

 

$

630,734

 

 

$

-

 

 

$

727,345

 

 

 

 

 

 

 

 

 

 

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

December 31, 2023

 

 

 

 

 

 

 

 

 

 

 

Assets

 

 

 

 

 

 

 

 

 

 

 

Money market funds

$

131,635

 

 

$

-

 

 

$

-

 

 

$

131,635

 

U.S. treasuries

 

-

 

 

 

74,237

 

 

 

-

 

 

 

74,237

 

U.S. government agency securities

 

-

 

 

 

216,688

 

 

 

-

 

 

 

216,688

 

Corporate debt securities

 

-

 

 

 

308,552

 

 

 

-

 

 

 

308,552

 

Total assets

$

131,635

 

 

$