UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form
(Mark One)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
or
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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:
(Exact name of registrant as specified in its charter)
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(State or other jurisdiction of |
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(IRS Employer |
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(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:
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Title of each class: |
Trading symbol(s): |
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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.
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).
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.
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Accelerated filer |
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Non-accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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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 2, 2019, the registrant had outstanding
INDEX
DYNAVAX TECHNOLOGIES CORPORATION
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Page No. |
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Item 1. |
4 |
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Condensed Consolidated Balance Sheets as of June 30, 2019 and December 31, 2018 |
4 |
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5 |
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5 |
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6 |
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Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2019 and 2018 |
7 |
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8 |
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Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
22 |
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Item 3. |
28 |
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Item 4. |
28 |
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Item 1. |
29 |
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Item 1A. |
29 |
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Item 2. |
44 |
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Item 5. |
44 |
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Item 6. |
45 |
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47 |
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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 our ability to successfully commercialize HEPLISAV-B® and our anticipated market opportunity and level of sales of HEPLISAV-B, our ability to successfully develop and timely obtain regulatory approval of SD-101, DV281 and our other early stage compounds or successfully pursue strategic alternatives for such compounds, our business, collaboration and regulatory strategy, our ability to achieve anticipated cost reductions and whether or not we may incur other material charges not currently contemplated due to events that may occur as a result of, or associated with our restructuring, our intellectual property position, our product development efforts, our ability to manufacture commercial supply and meet regulatory requirements, the timing of the introduction of our products, 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, where appropriate, its subsidiary Dynavax GmbH.
3
PART I. FINANCIAL INFORMATION
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ITEM 1. |
FINANCIAL STATEMENTS |
Dynavax Technologies Corporation
Condensed Consolidated Balance Sheets
(In thousands, except per share amounts)
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June 30, |
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December 31, |
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2019 |
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2018 |
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(unaudited) |
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(Note 1) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
$ |
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$ |
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Marketable securities available-for-sale |
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Accounts and other receivables, net |
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Inventories, net |
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Prepaid expenses and other current assets |
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Total current assets |
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Property and equipment, net |
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Intangible assets, net |
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Operating lease right-of-use assets |
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- |
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Goodwill |
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Restricted cash |
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Other assets |
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Total assets |
$ |
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$ |
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Liabilities and stockholders’ equity |
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Current liabilities: |
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Accounts payable |
$ |
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$ |
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Accrued research and development |
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Accrued liabilities |
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Other current liabilities |
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Total current liabilities |
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Long-term debt, net |
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Long-term portion of lease liabilities |
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- |
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Other long-term liabilities |
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Total liabilities |
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Commitments and contingencies (Note 6) |
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Stockholders’ equity: |
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Preferred stock: $ December 31, 2018; December 31, 2018 |
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Common stock: $ June 30, 2019 and December 31, 2018; issued and outstanding at June 30, 2019 and December 31, 2018, respectively |
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Additional paid-in capital |
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Accumulated other comprehensive loss |
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( |
) |
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( |
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Accumulated deficit |
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( |
) |
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( |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity |
$ |
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$ |
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See accompanying notes.
4
Dynavax Technologies Corporation
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
(Unaudited)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2019 |
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2018 |
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2019 |
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2018 |
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Revenues: |
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Product revenue, net |
$ |
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$ |
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$ |
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$ |
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Collaboration revenue |
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- |
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- |
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- |
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Total revenues |
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Operating expenses: |
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Cost of sales - product |
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Cost of sales - amortization of intangible assets |
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Research and development |
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Selling, general and administrative |
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Restructuring |
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- |
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- |
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Total operating expenses |
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Loss from operations |
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( |
) |
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( |
) |
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( |
) |
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( |
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Other income (expense): |
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Interest income |
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Interest expense |
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( |
) |
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( |
) |
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( |
) |
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( |
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Other (expense) income, net |
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( |
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Net loss |
$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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$ |
( |
) |
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Basic and diluted net loss per share |
$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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Weighted average shares used to compute basic and diluted net loss per share |
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Condensed Consolidated Statements of Comprehensive Loss
(In thousands)
(Unaudited)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2019 |
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2018 |
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2019 |
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2018 |
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Net loss |
$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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Other comprehensive income (loss), net of tax: |
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Unrealized gain (loss) on marketable securities available-for-sale |
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( |
) |
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Foreign currency translation adjustments |
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( |
) |
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( |
) |
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( |
) |
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Total other comprehensive income (loss) |
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( |
) |
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( |
) |
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Total comprehensive loss |
$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
See accompanying notes.
5
Dynavax Technologies Corporation
Condensed Consolidated Statements of Stockholders’ Equity
(In thousands)
(Unaudited)
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Common Stock |
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Three Months Ended June 30, 2019 |
Shares |
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Par Amount |
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Additional Paid-In Capital |
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Accumulated Other Comprehensive (Loss) Income |
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Accumulated Deficit |
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Total Stockholders' Equity |
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Balances at March 31, 2019 |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
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$ |
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Issuance of common stock upon exercise of stock options and restricted stock awards, net |
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- |
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- |
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- |
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Issuance of common stock, net of issuance costs |
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- |
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- |
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- |
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Stock compensation expense |
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- |
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- |
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- |
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- |
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Total other comprehensive income |
|
- |
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- |
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- |
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- |
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Net loss |
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- |
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- |
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- |
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|
|
- |
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|
( |
) |
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|
( |
) |
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Balances at June 30, 2019 |
|
|
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|
$ |
|
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|
$ |
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|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
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Six Months Ended June 30, 2019 |
|
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|
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Balances at December 31, 2018 |
|
|
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|
$ |
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|
$ |
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|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
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|
|
Issuance of common stock upon exercise of stock options and restricted stock awards, net |
|
|
|
|
|
- |
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|
|
|
|
|
|
- |
|
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|
- |
|
|
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Issuance of common stock under Employee Stock Purchase Plan |
|
|
|
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
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Issuance of common stock, net of issuance costs |
|
|
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|
|
|
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
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Stock compensation expense |
|
- |
|
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|
- |
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|
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|
|
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|
- |
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|
- |
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Total other comprehensive income |
|
- |
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|
- |
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|
|
- |
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|
|
|
|
|
|
- |
|
|
|
|
|
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Net loss |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
|
( |
) |
|
Balances at June 30, 2019 |
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
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Common Stock |
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Three Months Ended June 30, 2018 |
Shares |
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Par Amount |
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Additional Paid-In Capital |
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Accumulated Other Comprehensive (Loss) Income |
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Accumulated Deficit |
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Total Stockholders' Equity |
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||||||
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Balances at March 31, 2018 |
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
|
Issuance (withholding) of common stock upon exercise of stock options and restricted stock awards, net |
|
|
|
|
|
|
|
|
|
( |
) |
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
Stock compensation expense |
|
- |
|
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
Total other comprehensive loss |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
|
- |
|
|
|
( |
) |
|
Net loss |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
|
( |
) |
|
Balances at June 30, 2018 |
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
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Six Months Ended June 30, 2018 |
|
|
|
|
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|
|
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|
|
|
|
|
|
|
|
|
|
|
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|
Balances at December 31, 2017 |
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
|
Issuance (withholding) of common stock upon exercise of stock options and restricted stock awards, net |
|
|
|
|
|
|
|
|
|
( |
) |
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
Issuance of common stock under Employee Stock Purchase Plan |
|
|
|
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
Stock compensation expense |
|
- |
|
|
|
- |
|
|
|
|
|
|
|
- |
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|
|
- |
|
|
|
|
|
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Total other comprehensive loss |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
|
- |
|
|
|
( |
) |
|
Net loss |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
|
( |
) |
|
Balances at June 30, 2018 |
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
See accompanying notes.
6
Dynavax Technologies Corporation
Condensed Consolidated Statements of Cash Flows
(In thousands)
(Unaudited)
|
|
Six Months Ended June 30, |
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|||||
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2019 |
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2018 |
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Operating activities |
|
|
|
|
|
|
|
|
Net loss |
$ |
( |
) |
|
$ |
( |
) |
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
|
|
|
|
|
|
Amortization of right-of-use assets |
|
|
|
|
|
- |
|
|
Accretion of discounts on marketable securities |
|
( |
) |
|
|
( |
) |
|
Stock compensation expense |
|
|
|
|
|
|
|
|
Cost of sales - amortization of intangible assets |
|
|
|
|
|
|
|
|
Non-cash interest expense |
|
|
|
|
|
|
|
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts and other receivables, net |
|
( |
) |
|
|
( |
) |
|
Inventories, net |
|
( |
) |
|
|
( |
) |
|
Prepaid expenses and other current assets |
|
( |
) |
|
|
( |
) |
|
Other assets |
|
|
|
|
|
( |
) |
|
Accounts payable |
|
|
|
|
|
|
|
|
Lease liabilities |
|
( |
) |
|
|
- |
|
|
Accrued liabilities and other liabilities |
|
( |
) |
|
|
|
|
|
Net cash used in operating activities |
|
( |
) |
|
|
( |
) |
|
Investing activities |
|
|
|
|
|
|
|
|
Acquisition of technology licenses |
|
( |
) |
|
|
( |
) |
|
Purchases of marketable securities |
|
( |
) |
|
|
( |
) |
|
Proceeds from maturities of marketable securities |
|
|
|
|
|
|
|
|
Purchases of property and equipment, net |
|
( |
) |
|
|
( |
) |
|
Net cash used in investing activities |
|
( |
) |
|
|
( |
) |
|
Financing activities |
|
|
|
|
|
|
|
|
Proceeds from long-term debt, net |
|
|
|
|
|
|
|
|
Proceeds from issuance of common stock, net |
|
|
|
|
|
- |
|
|
Proceeds (tax withholding) from exercise of stock options and restricted stock awards, net |
|
|
|
|
|
( |
) |
|
Proceeds from Employee Stock Purchase Plan |
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
|
|
|
|
|
|
Effect of exchange rate changes on cash, cash equivalents and restricted cash |
|
( |
) |
|
|
( |
) |
|
Net (decrease) increase in cash, cash equivalents and restricted cash |
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