e8vk
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D) OF THE
SECURITIES AND EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): July 31, 2007
DYNAVAX TECHNOLOGIES
CORPORATION
(Exact name of registrant as specified in charter)
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Delaware
(State or other jurisdiction of
incorporation)
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000-50577
(Commission File Number)
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33-0728374
(I.R.S. Employer Identification No.) |
2929 Seventh Street, Suite 100
Berkeley, California 94710
(Address of principal executive offices and zip code)
Registrants telephone number, including area code: (510) 848-5100
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c)) |
Item 2.02. Results of Operations and Financial Condition.
On July 31, 2007, Dynavax Technologies Corporation issued a press release announcing its fiscal
2007 second quarter financial results. A copy of the press release is attached as Exhibit 99.1 to
this current report and is incorporated herein by reference.
The information in this current report and in the 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 Technologies Corporation, whether made before or after the date hereof,
regardless of any general incorporation language in such filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
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Exhibit No. |
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Description |
99.1
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Press release, dated July 31, 2007 entitled Dynavax
Announces Second Quarter 2007 Financial Results. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly
caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.
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Dynavax Technologies Corporation
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Dated: August 1, 2007 |
By: |
/s/ Michael Ostrach |
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Michael Ostrach, Vice President, Chief Business |
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Officer and General Counsel |
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INDEX TO EXHIBITS
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Exhibit |
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Number |
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Description |
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99.1
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Press release, dated July 31, 2007 entitled Dynavax
Announces Second Quarter 2007 Financial Results. |
exv99w1
Exhibit 99.1
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2929 Seventh Street, Suite 100 |
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Berkeley, CA 94710 |
Contact:
Dynavax Technologies Corporation
Deborah A. Smeltzer
VP Operations & Chief Financial Officer
Phone (510) 665-7222
Email: dsmeltzer@dynavax.com
DYNAVAX ANNOUNCES SECOND QUARTER 2007 FINANCIAL RESULTS
BERKELEY, Calif. July 31, 2007 Dynavax Technologies Corporation (Nasdaq: DVAX) today reported
financial results for the second quarter and six months ended June 30, 2007.
As of June 30, 2007, Dynavax reported cash, cash equivalents, marketable securities and investments
held by Symphony Dynamo, Inc. (SDI) totaling $82.6 million. This compares to $86.2 million at
December 31, 2006.
Both of Dynavaxs advanced product candidates, HEPLISAV for the prevention of hepatitis B and
TOLAMBA for the treatment of ragweed allergy, have progressed. With the expected completion of the
pivotal HEPLISAV trial in Canada and in Europe, we have an opportunity to submit a BLA in 2008. The
recently announced project financing from Deerfield Management for TOLAMBA provides us with the
tools to design and implement studies that could, if successful, lead to a BLA submission. Clearly,
these are accomplishments that underscore the broadly enabling product potential of our TLR9
agonist approach, said Dino Dina, MD, president and chief executive officer.
Total revenues were $1.8 million and $3.8 million for the three and six months ended June 30, 2007,
respectively, compared to $0.5 million and $0.8 million for the same periods in 2006. The increase
in revenues resulted from our collaboration with AstraZeneca, service and license revenue from
customers of Dynavax Europe, and grant revenue primarily from the NIH. The reported revenues do not
include collaboration funding from SDI. Including the collaboration funding from SDI, pro forma
revenues were $4.9 million and $10.4 million, respectively, for the three and six months ended June
30, 2007, compared to $2.5 million and $2.8 million for the same periods in 2006.
more
Dynavax 2Q 2007 Results
July 31, 2007
Page 2 of 6
Total operating expenses were $23.6 million and $41.7 million for the three and six months ended
June 30, 2007, respectively, compared to $18.5 million and $27.7 million for the same periods in
2006. The increase in operating expenses resulted primarily from increased clinical development and
licensing activities related to the Companys product candidate HEPLISAV, the expansion of the
Companys operations to include Dynavax Europe, and reimbursable expenses related to SDI programs.
Operating expenses include a one-time $5 million license payment for the commercialization of
HEPLISAV, and non-cash charges for stock-based compensation, acquired in-process research and
development and amortization of intangible assets resulting from the April 2006 acquisition of
Rhein Biotech GmbH (Dynavax Europe). Excluding one-time and non-cash charges, pro forma operating
expenses were $17.7 million and $34.7 million, respectively, for the three and six months ended
June 30, 2007, compared to $13.4 million and $21.9 million for the same periods in 2006.
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.
Net loss for the second quarter 2007 was $17.7 million, or $0.45 per share, compared to a net loss
of $15.3 million, or $0.50 per share, for the same period in 2006. Net loss for the six months of
2007 was $30.8 million, or $0.78 per share, compared to a net loss of $23.4 million, or $0.77 per
share, for the same period in 2006. The increase in net loss was due primarily to increased
clinical development expenditures on the Companys product candidates and overall organizational
growth. The increase in shares used to compute net loss per share resulted from the Companys
equity financing activities completed in the fourth quarter 2006.
About Dynavax
Dynavax Technologies Corporation discovers, develops, and intends to commercialize innovative TLR9
agonist-based products to treat and prevent infectious diseases, allergies, cancer, and chronic
inflammatory diseases using versatile, proprietary approaches that alter immune system responses in
highly specific ways. Our TLR9 agonists are based on immunostimulatory sequences, or ISS, which are
short DNA sequences that enhance the ability of the immune system to fight disease and control
chronic inflammation. Our product candidates include: HEPLISAV, a hepatitis B vaccine in Phase 3;
TOLAMBA, a clinical ragweed allergy immunotherapy; a therapy for non-Hodgkins lymphoma (NHL) in
Phase 2 and for metastatic colorectal cancer in Phase 1; and a therapy for hepatitis B also in
Phase 1. Our preclinical asthma and COPD program is partnered with AstraZeneca. Our preclinical
work on a vaccine for influenza is partially funded by the NIH. Our colorectal cancer trial and our
preclinical hepatitis C therapeutic program are funded by Symphony Dynamo, Inc. While the NIH and
SDI provide program support, Dynavax has retained rights to seek strategic partners for future
development and commercialization. For more information, please visit
http://www.dynavax.com.
more
Dynavax 2Q 2007 Results
July 31, 2007
Page 3 of 6
This press release contains forward-looking statements that are subject to a number of risks and
uncertainties, including statements about planned clinical trials and BLA submissions for our
product candidates HEPLISAV and TOLAMBA and our financial position. Actual results may differ
materially from those set forth in this press release due to the risks and uncertainties inherent
in our business, including difficulties or delays in development and achieving our related
timelines; achieving the objectives of our collaborative and licensing agreements such as our SDI
and AstraZeneca arrangements; and obtaining regulatory approval for our products; the scope and
validity of patent protection for our products; possible claims against us based on the patent
rights of others; our ability to obtain additional financing to support our operations; and other
risks detailed in the Risk Factors section of our Quarterly Report on Form 10-Q. We undertake no
obligation to revise or update information herein to reflect events or circumstances in the future,
even if new information becomes available.
Tables to follow
Dynavax 2Q 2007 Results
July 31, 2007
Page 4 of 6
DYNAVAX TECHNOLOGIES CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(Unaudited)
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Three Months Ended |
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Six Months Ended |
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June 30, |
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June 30, |
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2007 |
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2006 |
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2007 |
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2006 |
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Revenues: |
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Collaboration revenue |
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$ |
752 |
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$ |
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$ |
1,499 |
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$ |
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Service and license revenue |
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461 |
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224 |
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570 |
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224 |
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Grant revenue |
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587 |
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305 |
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1,715 |
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593 |
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Total revenues |
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1,800 |
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529 |
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3,784 |
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817 |
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Operating expenses: |
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Research and development (2) |
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19,164 |
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10,762 |
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32,796 |
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17,354 |
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General and administrative (3) |
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4,206 |
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3,380 |
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8,386 |
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5,983 |
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Acquired in-process research and
development |
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4,180 |
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4,180 |
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Amortization of intangible assets |
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252 |
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196 |
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503 |
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196 |
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Total operating expenses (1) |
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23,622 |
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18,518 |
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41,685 |
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27,713 |
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Loss from operations |
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(21,822 |
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(17,989 |
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(37,901 |
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(26,896 |
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Interest and other income, net |
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1,081 |
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685 |
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2,054 |
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1,420 |
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Loss including noncontrolling
interest in Symphony Dynamo, Inc |
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(20,741 |
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(17,304 |
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(35,847 |
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(25,476 |
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Amount attributed to noncontrolling
interest in Symphony Dynamo, Inc |
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3,037 |
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2,031 |
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5,053 |
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2,031 |
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Net loss |
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$ |
(17,704 |
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$ |
(15,273 |
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$ |
(30,794 |
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$ |
(23,445 |
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Basic and diluted net loss per share |
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$ |
(0.45 |
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$ |
(0.50 |
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$ |
(0.78 |
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$ |
(0.77 |
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Shares used to compute basic and
diluted net loss per share |
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39,741 |
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30,536 |
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39,734 |
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30,524 |
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(1) |
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Total operating expenses excluding non-cash stock-based compensation charges are $22.9
million and $40.2 million for the three and six months ended June 30, 2007, respectively.
Total operating expenses excluding non-cash stock-based compensation charges are $17.8
million and $26.3 million for the three and six months ended June 30, 2006, respectively. |
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(2) |
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Research and development expenses included non-cash stock-based compensation charges
of $0.3 million and $0.5 million for the three and six months ended June 30, 2007,
respectively. Research and development expenses included non-cash stock-based compensation
charges of $0.3 million and $0.6 million for the three and six months ended June 30, 2006,
respectively. |
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(3) |
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General and administrative expenses included non-cash stock-based compensation
charges of $0.4 million and $1.0 million for the three and six months ended June 30, 2007,
respectively. General and administrative expenses included non-cash stock-based
compensation charges of $0.5 million and $0.8 million for the three and six months ended
June 30, 2006, respectively. |
more
Dynavax 2Q 2007 Results
July 31, 2007
Page 5 of 6
DYNAVAX TECHNOLOGIES CORPORATION
RECONCILIATION OF GAAP REVENUES TO PRO FORMA REVENUES
(In thousands)
(Unaudited)
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Three Months Ended |
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Six Months Ended |
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June 30, |
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June 30, |
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2007 |
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2006 |
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2007 |
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2006 |
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GAAP revenues |
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$ |
1,800 |
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$ |
529 |
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$ |
3,784 |
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$ |
817 |
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ADD: |
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Collaboration funding incurred under SDI programs |
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3,136 |
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1,998 |
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6,632 |
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1,998 |
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Pro forma revenues (1) |
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$ |
4,936 |
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$ |
2,527 |
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$ |
10,416 |
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$ |
2,815 |
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(1) |
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These pro forma amounts are intended to illustrate the companys revenues to be
inclusive of collaboration funding provided for the SDI programs. 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 programs funded under
the SDI arrangement. 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)
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Three Months Ended |
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Six Months Ended |
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June 30, |
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June 30, |
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2007 |
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2006 |
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2007 |
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2006 |
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GAAP operating expenses |
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$ |
23,622 |
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$ |
18,518 |
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$ |
41,685 |
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$ |
27,713 |
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LESS: |
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Licensing fee |
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5,000 |
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5,000 |
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Stock-based compensation expense |
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698 |
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730 |
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1,497 |
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1,396 |
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Acquired in-process research and development |
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4,180 |
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4,180 |
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Amortization of intangible assets |
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252 |
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196 |
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503 |
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196 |
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Pro forma operating expenses (2) |
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$ |
17,681 |
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$ |
13,412 |
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$ |
34,685 |
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$ |
21,941 |
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(2) |
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These pro forma amounts are intended to illustrate the companys operating expenses
excluding certain non-cash charges in accordance with the financials 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 2Q 2007 Results
July 31, 2007
Page 6 of 6
DYNAVAX TECHNOLOGIES CORPORATION
SELECTED BALANCE SHEET DATA
(In thousands)
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June 30, |
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December 31, |
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2007 |
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2006 |
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Assets |
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(unaudited) |
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Cash and cash equivalents and marketable securities (1) |
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$ |
82,578 |
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$ |
86,194 |
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Property and equipment, net |
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6,040 |
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5,200 |
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Goodwill |
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2,312 |
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2,312 |
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Other intangible assets, net |
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3,879 |
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4,382 |
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Other assets |
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3,673 |
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4,802 |
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Total assets |
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$ |
98,482 |
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$ |
102,890 |
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Liabilities, noncontrolling interest and stockholders equity |
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Current liabilities |
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$ |
13,589 |
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$ |
13,701 |
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Noncurrent portion of deferred revenue |
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10,000 |
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10,000 |
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Other long-term liabilities |
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9,531 |
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117 |
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Noncontrolling interest in Symphony Dynamo, Inc |
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17,514 |
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2,016 |
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Stockholders equity |
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47,848 |
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|
77,056 |
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Total liabilities, noncontrolling interest and stockholders
equity |
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$ |
98,482 |
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$ |
102,890 |
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(1) |
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These amounts also include investments held by Symphony Dynamo, Inc. of $35.1 million
as of June 30, 2007. |
# # #