Delaware
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33-0728374
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(State or other jurisdiction of
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(IRS Employer
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incorporation)
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Identification No.)
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The information with respect to item 2.02 in this current report and its accompanying exhibit shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this current report and in the accompanying exhibit shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by Dynavax, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Dynavax Technologies Corporation
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Date: May 06, 2010
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By:
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/s/ Michael S. Ostrach
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Michael S. Ostrach
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Vice President
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Exhibit No.
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Description
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EX-99.1
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Press Release, dated May 6, 2010 titled "Dynavax Reports 2010 First Quarter Financial Results."
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EX-5.1
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Opinion of Cooley LLP.
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Exhibit 99.1 |
DYNAVAX |
DYNAVAX TECHNOLOGIES 2929 Seventh Street, Suite 100 Berkeley, CA 94710 |
Contact: Jennifer Lew Vice President, Finance 510-665-7217 jlew@dynavax.com |
DYNAVAX REPORTS 2010 FIRST QUARTER FINANCIAL RESULTS
Conference Call and Webcast Today at 4:30 pm EDT
BERKELEY, CA May 6, 2010 Dynavax Technologies Corporation (NASDAQ: DVAX) today reported financial results for the first quarter ended March 31, 2010, including $30.1 million in cash and cash equivalents. Total cash for the first quarter 2010 does not include $41 million in net proceeds from the public offering completed on April 16, 2010.
With the completion of the recent financing, we are poised to achieve our most critical goals, including completion of the Phase 3 study required for submitting our BLA for HEPLISAVTM, initiating clinical development for our Universal Flu and TLR autoimmune products, and positioning hepatitis B and C therapeutics for out-licensing, noted Dino Dina, M.D., President and CEO.
The tables included as part of this press release provide a reconciliation of GAAP revenues and operating expenses to pro forma revenues and operating expenses.
Conference Call |
Dynavax will webcast a conference call today at 4:30 p.m. EDT (1:30 p.m. PDT). The live and archived webcast can be accessed by visiting the investor relations section of the Company's Web site at http://investors.dynavax.com/newsevents.cfm.
About HEPLISAV |
HEPLISAV is an investigational adult hepatitis B vaccine. The vaccine candidate is being evaluated in two Phase 3 studies that are directed toward fulfilling licensure requirements in U.S., Canada and Europe. In a completed pivotal Phase 3 trial, HEPLISAV demonstrated increased, rapid protection with fewer doses than current licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV and is developing the vaccine for large, high-value populations that are less responsive to current licensed vaccines, including individuals with chronic kidney disease. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist known as ISS to enhance the immune response.
more |
About Dynavax |
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV, an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Forward Looking Statements |
This press release contains forward-looking statements, that are subject to a number of risks and uncertainties, including statements relating to clinical trials and BLA submission. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether successful clinical and regulatory development and approval of HEPLISAV can occur in a timely manner or without significant additional studies or difficulties or delays in development or clinical trial enrollment, whether the studies can support registration for commercialization of HEPLISAV; the results of clinical trials and the impact of those results on the initiation and completion of subsequent trials and issues arising in the regulatory process; the Company's ability to obtain additional financing to support the development and commercialization of HEPLISAV and its other operations, possible claims against the Company based on the patent rights of others; and other risks detailed in the Risk Factors section of our current periodic reports with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavaxs website at www.dynavax.com is not incorporated by reference in the Companys current periodic reports with the SEC.
tables to follow |
DYNAVAX TECHNOLOGIES CORPORATION | ||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
(In thousands, except per share amounts) | ||||||||
(Unaudited) | ||||||||
Three Months Ended | ||||||||
March 31, | ||||||||
2010 | 2009 | |||||||
Revenues: | ||||||||
Collaboration revenue | $ | 7,421 | $ | 17,692 | ||||
Grant revenue | 862 | 1,139 | ||||||
Service and license revenue | 61 | 513 | ||||||
Total revenues | 8,344 | 19,344 | ||||||
Operating expenses: | ||||||||
Research and development | 12,480 | 10,332 | ||||||
General and administrative | 4,570 | 4,424 | ||||||
Amortization of intangible assets | 245 | 245 | ||||||
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Total operating expenses | 17,295 | 15,001 | ||||||
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Loss from operations | (8,951) | 4,343 | ||||||
Interest income | 2 | 110 | ||||||
Interest expense | (399) | (15) | ||||||
Other income (expense) | 164 | (346) | ||||||
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Net income (loss) | (9,184) | 4,092 | ||||||
Add: Losses attributed to noncontrolling interest in SDI | | 1,009 | ||||||
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Net income (loss) attributable to Dynavax | $ | (9,184) | $ | 5,101 | ||||
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Basic and diluted net income (loss) per share attributable to | ||||||||
Dynavax common stockholders | $ | (0.17) | $ | 0.13 | ||||
Shares used to compute basic net income (loss) per share | ||||||||
attributable to Dynavax common stockholders | 54,364 | 39,889 | ||||||
more |
DYNAVAX TECHNOLOGIES CORPORATION
RECONCILIATION OF GAAP REVENUES TO PRO FORMA REVENUES (In thousands) (Unaudited)
Three Months Ended | ||||||||
March 31, | ||||||||
2010 | 2009 | |||||||
GAAP revenues | $ | 8,344 | $ | 19,344 | ||||
ADD: | ||||||||
Collaboration funding incurred under SDI programs | | 747 | ||||||
LESS: | ||||||||
Non-cash deferred revenue from Merck collaboration | | 15,537 | ||||||
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Pro forma revenues (1) | $ | 8,344 | $ | 4,554 | ||||
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(1) | These pro forma amounts are intended to illustrate the Companys revenues including collaboration funding provided for the SDI programs and excluding certain non-cash items. The collaboration funding is reflected in the amount attributed to the noncontrolling interest in SDI in the Companys consolidated statement of operations, but would have been reported as revenue if SDIs results of operations were not consolidated with those of the Company. Management of the Company believes the pro forma results are a more useful measure of the Companys revenues because it provides investors the ability to evaluate the Companys operations in the manner that management uses to assess the continued progress of operating programs. |
These pro forma results are not in accordance with, or an alternative for, generally accepted accounting principles and may be different from pro forma measures used by other companies. | |
DYNAVAX TECHNOLOGIES CORPORATION
RECONCILIATION OF GAAP OPERATING EXPENSES TO PRO FORMA OPERATING EXPENSES
(In thousands) (Unaudited)
Three Months Ended | ||||
March 31, | ||||
2010 | 2009 | |||
GAAP operating expenses | $ 17,295 | $ 15,001 | ||
LESS: | ||||
Stock-based compensation expense | 541 | 519 | ||
Amortization of intangible assets | 245 | 245 | ||
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Pro forma operating expenses (2) | $ 16,509 | $ 14,237 |
(2) | These pro forma amounts are intended to illustrate the Companys operating expenses excluding certain non-cash charges in accordance with the financial statements that management uses to evaluate the Companys operations. These pro forma results are not in accordance with, or an alternative for, generally accepted accounting principles and may be different from pro forma measures used by other companies. |
more |
DYNAVAX TECHNOLOGIES CORPORATION | ||||||||
SELECTED BALANCE SHEET DATA | ||||||||
(In thousands) | ||||||||
(Unaudited) | ||||||||
March 31, | December 31, | |||||||
2010 | 2009 | |||||||
Assets | ||||||||
Cash and cash equivalents and marketable securities | $ | 30,080 | $ | 36,720 | ||||
Property and equipment, net | 7,199 | 7,997 | ||||||
Goodwill | 2,312 | 2,312 | ||||||
Other intangible assets, net | 1,034 | 1,279 | ||||||
Other assets | 3,659 | 2,162 | ||||||
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Total assets | $ | 44,284 | $ | 50,470 | ||||
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Liabilities and stockholders equity | ||||||||
Accounts payable | $ | 1,091 | $ | 1,686 | ||||
Accrued liabilities | 10,571 | 7,507 | ||||||
Warrant liability to Holdings | 2,315 | 2,567 | ||||||
Current portion of deferred revenue | 2,384 | 2,718 | ||||||
Noncurrent portion of deferred revenue | 16,726 | 17,083 | ||||||
Long-term note payable to Holdings | 9,741 | 9,342 | ||||||
Long-term contingent liability to Holdings | 3,109 | 3,040 | ||||||
Other long-term liabilities | 146 | 151 | ||||||
Stockholders equity (deficit) | (1,799) | 6,376 | ||||||
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Total liabilities and stockholders equity | $ | 44,284 | $ | 50,470 | ||||
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# # # |
May 6, 2010
Dynavax Technologies Corporation
2929 Seventh Street, Suite 100
Berkeley, CA 94710
RE: Dynavax Technologies Corporation
Ladies and Gentlemen:
You have requested our opinion with respect to certain matters in connection with the sale by Dynavax Technologies Corporation (the "Company") of 800,860 shares of the Company's Common Stock (the "Shares") under the Equity Distribution Agreement dated as of August 17, 2009 by and between the Company and Wedbush Morgan Securities, Inc. (the "Agreement").
In connection with this opinion, we have examined and relied upon the representations and warranties as to factual matters contained in and made pursuant to the Agreement by the various parties and originals or copies certified to our satisfaction, of such records, documents, certificates, opinions, memoranda and other instruments as in our judgment are necessary or appropriate to enable us to render the opinion expressed below.
In rendering this opinion, we have assumed: the genuineness and authenticity of all signatures on original documents; the authenticity of all documents submitted to us as originals; the conformity to originals of all documents submitted to us as copies; the accuracy, completeness and authenticity of certificates of public officials; and the due authorization, execution and delivery of all documents, where authorization, execution and delivery are prerequisites to the effectiveness of such documents. We have also assumed that all individuals executing and delivering documents had the legal capacity to so execute and deliver.
On the basis of the foregoing, in reliance thereon and with the foregoing qualification, we are of the opinion that the Shares have been duly authorized and validly issued and are outstanding, fully paid and nonassessable.
Very truly yours,
Cooley llp
By: /s/ Glen Y. Sato
Glen Y. Sato