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 27, 2006
DYNAVAX TECHNOLOGIES CORPORATION
(Exact name of registrant as specified in charter)
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Delaware |
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000-50577 |
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33-0728374 |
(State or other jurisdiction of incorporation)
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(Commission File Number)
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(I.R.S. Employer
Identification No.) |
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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:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o 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 27, 2006, Dynavax Technologies Corporation issued a press release announcing its
fiscal 2006 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.
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Exhibit |
Number |
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Description |
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99.1 |
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Press Release, dated July 27,
2006, announcing Dynavax Technologies
Corporation Fiscal 2006 Second Quarter 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: July 27, 2006 |
By: |
/s/ Deborah A. Smeltzer
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Deborah A. Smeltzer, Vice President |
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Operations and Chief Financial Officer |
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INDEX TO EXHIBITS
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Exhibit |
Number |
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Description |
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99.1 |
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Press Release, dated July 27,
2006, announcing Dynavax Technologies
Corporation Fiscal 2006 Second Quarter Financial Results. |
exv99w1
Exhibit 99.1
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2929 Seventh Street, Suite 100
Berkeley, CA 94710 |
Contact:
Dynavax Technologies Corporation
Jane M. Green, PhD
Corporate Communications
Phone (510) 665-4630
Email: jgreen@dvax.com
DYNAVAX ANNOUNCES SECOND QUARTER 2006
FINANCIAL RESULTS
BERKELEY, Calif. July 27, 2006 Dynavax Technologies Corporation (Nasdaq: DVAX) today reported
financial results for the second quarter 2006.
During the second quarter 2006, Dynavax completed two significant transactions designed to expand
the Companys operations and advance its early-stage pipeline. These transactions as well as
related charges are reflected in the Companys consolidated financial statements.
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Symphony Dynamo, Inc. (SDI) was created in connection with a collaboration with Symphony
Capital Partners, LP to advance specific ISS-based programs for cancer, hepatitis B therapy
and hepatitis C therapy through certain stages of clinical development. During the second
quarter 2006, SDI received $20 million of the $50 million funding commitment. The results
of operations of SDI are included in the consolidated results of Dynavax since the date of
formation. |
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Dynavax acquired Rhein Biotech GmbH (Rhein), renamed Dynavax Europe, through which the
Company gained ownership of a current European GMP-certified vaccine manufacturing
facility, control over the production and supply of its hepatitis B surface antigen, and
management and personnel with expertise in biopharmaceutical product development and
production. The results of operations of Rhein are included in the consolidated results of
Dynavax since the date of acquisition. |
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One-time cash payments totaling approximately $17 million were made during the quarter
relating to these transactions. |
Total revenues for the second quarter ended June 30, 2006 were $0.5 million compared to $1.0
million for the same period in 2005. Revenues in the second quarter 2006 consisted of services and
license fees from Dynavax Europe for the first time and grants awarded by the National Institute of
Allergy and Infectious Diseases and by the Alliance for Lupus Research. Total revenues for the six
months ended June 30, 2006 were $0.8 million compared to $13.7 million for the same period in 2005.
Collaboration revenue for the six months ended June 30, 2005 included accelerated recognition of
$7.0 million in deferred revenue following the end of Dynavaxs collaboration with UCB Farchim in
March 2005.
Total operating expenses were $18.5 million for the second quarter 2006 compared to $10.0 million
for the same period in 2005. Total operating expenses for the six months ended June 30, 2006 were
$27.7 million compared to $18.0 million for the comparable period in 2005. Total operating expenses
in the second quarter 2006 increased by $8.5 million, which included a one-time charge of $4.2
million for acquired in-process research and development resulting from the April 2006 acquisition
of Rhein, and $4.3 million from ongoing operating expenses. The growth in ongoing operating
expenses resulted primarily from increased activities related to the Companys lead product
candidates TOLAMBA and HEPLISAV, as well as the expansion of the Companys operations from
Dynavax Europe and programs funded by SDI.
Reimbursable expenses related to the SDI programs were $2.0 million for the three and six months
ended June 30, 2006, as reflected in Loss attributed to noncontrolling interest in Symphony Dynamo,
Inc. in the Companys Condensed Consolidated Statement of Operations.
Net loss for the second quarter ended June 30, 2006 was $15.3 million, or $0.50 per diluted share,
compared to net loss of $8.6 million, or $0.35 per diluted share, for the same period in 2005. The
increase in net loss for the quarter ended June 30, 2006 was due primarily to increased operating
expenses associated with the Companys clinical programs and the non-recurring charge for acquired
in-process research and development. Net loss for the six months ended June 30, 2006 was $23.4
million, or $0.77 per diluted share, compared to $3.5 million, or $0.14 per diluted share, for the
same period in 2005.
As of June 30, 2006, Dynavax reported that cash, cash equivalents and marketable securities totaled
$41.7 million compared to $75.1 million at December 31, 2005. In addition, the Company reported
$19.0 million in investments held by SDI. Cash, cash equivalents and marketable securities declined
over the six month period in 2006 due to the one-time cash payments totaling approximately $17
million associated with the Rhein acquisition and the formation of SDI, and $16 million of net cash
used for ongoing operations.
Dynavax had a productive second quarter of 2006, said Dino Dina, MD, president and chief
executive officer. We implemented an innovative financing transaction with Symphony Capital
Partners designed to advance our second-generation TLR-based pipeline. We completed the acquisition
of Rhein as our European base of manufacturing operations. And, we rapidly and successfully
initiated the TOLAMBA DARTT study, and expanded the enrollment due to the high level of interest
among investigators and allergy sufferers in this novel, disease-modifying intervention. We
anticipate additional important clinical activities over the coming months
including initiation of a pivotal Phase 3 trial for HEPLISAV and initiation of trials in solid
tumors in our cancer program.
Conference Call and Webcast Today
Dynavax will hold a conference call to discuss these financial results today at 2:00 p.m. Pacific
Time / 5:00 p.m. Eastern Time. Interested parties may listen to the webcast live at
http://www.dynavax.com by clicking on the Events tab under the heading, Investors. The webcast
is also being distributed over CCBNs Investor Distribution Network to both institutional and
individual investors. Individual investors can listen to the call through CCBNs individual
investor center at http://www.fulldisclosure.com or by visiting any of the investor sites in
CCBNs Individual Investor Network. Institutional investors can access the call via CCBNs
password-protected event management site, StreetEvents, at http://www.streetevents.com. A
telephonic replay will be available through August 3, 2006 by dialing 888.286.8010, access code:
67521357. International callers can dial 617.801.6888, access code: 67521357.
About Dynavax
Dynavax Technologies Corporation discovers, develops, and intends to commercialize innovative TLR-9
agonist-based products to treat and prevent allergies, infectious diseases, cancer, and chronic
inflammatory diseases using versatile, proprietary approaches that alter immune system responses in
highly specific ways. Our clinical development programs 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. Dynavaxs pipeline includes: TOLAMBA, a ragweed allergy
immunotherapeutic, for which a major safety and efficacy trial is currently underway, and that is
in a supportive clinical trial in ragweed allergic children; HEPLISAV, a hepatitis B vaccine that
is currently in a Phase 3 clinical trial; SUPERVAX, a hepatitis B vaccine; a cancer therapy
currently in a Phase 2 clinical trial and anticipated to enter clinical trials in solid tumors; an
asthma immunotherapeutic that has shown preliminary safety and pharmacology in a Phase 2a clinical
trial; and preclinical programs in hepatitis B therapy and hepatitis C therapy.
Dynavax cautions you that this press release contains forward-looking statements, including without
limitation the plans to initiate a pivotal Phase 3 trial for HEPLISAV and clinical trials in solid
tumors; and the potential for continued development of existing clinical programs. Actual results
may differ materially from those set forth in this release due to the risks and uncertainties
inherent in Dynavaxs business including, without limitation, risks relating to: the progress and
timing of its current and anticipated clinical trials; difficulties or delays in developing,
testing and manufacturing products to support clinical development plans; the scope and validity of
patent protection for product candidates; competition from other companies working with ISS
technologies and products; the ability to obtain additional financing to support operations; and
other risks detailed in the Risk Factors section of Dynavaxs Annual Report on Form 10-K and
Quarterly Report on Form 10-Q. All forward-looking statements are made as of the date hereof and
Dynavax undertakes no obligation to revise or update information provided in this press release.
***
DYNAVAX TECHNOLOGIES CORPORATION
CONDENSED 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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2006 |
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2005 |
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2006 |
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2005 |
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Revenues: |
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Collaboration revenue |
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$ |
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$ |
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$ |
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$ |
12,199 |
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Service and license revenue |
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224 |
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224 |
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Grant revenue |
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305 |
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953 |
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593 |
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1,452 |
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Total revenues |
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529 |
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953 |
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817 |
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13,651 |
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Operating expenses: |
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Research and development |
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10,762 |
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7,493 |
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17,354 |
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13,148 |
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General and administrative |
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3,380 |
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2,473 |
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5,983 |
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4,813 |
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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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196 |
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196 |
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Total operating expenses |
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18,518 |
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9,966 |
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27,713 |
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17,961 |
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Loss from operations |
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(17,989 |
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(9,013 |
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(26,896 |
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(4,310 |
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Interest and other income, net |
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685 |
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434 |
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1,420 |
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801 |
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Loss including noncontrolling interest in
Symphony Dynamo, Inc. |
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(17,304 |
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(8,579 |
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(25,476 |
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(3,509 |
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Loss attributed to noncontrolling interest in
Symphony Dynamo, Inc. |
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2,031 |
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2,031 |
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Net loss |
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$ |
(15,273 |
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$ |
(8,579 |
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$ |
(23,445 |
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$ |
(3,509 |
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Basic and diluted net loss per share |
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$ |
(0.50 |
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$ |
(0.35 |
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$ |
(0.77 |
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$ |
(0.14 |
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Shares used to compute basic and diluted net
loss per share |
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30,536 |
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24,745 |
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30,524 |
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24,734 |
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DYNAVAX TECHNOLOGIES CORPORATION
SELECTED BALANCE SHEET DATA
(In thousands)
(Unaudited)
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June 30, |
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December 31, |
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2006 |
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2005 |
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Assets |
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Cash and cash equivalents and marketable securities |
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$ |
41,703 |
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$ |
75,110 |
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Investments held by Symphony Dynamo, Inc. |
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19,044 |
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Other current assets |
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2,393 |
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2,374 |
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Property and equipment, net |
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4,986 |
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2,197 |
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Goodwill |
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2,312 |
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Other intangible assets, net |
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4,884 |
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Other assets |
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1,302 |
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412 |
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Total assets |
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$ |
76,624 |
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$ |
80,093 |
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Liabilities, noncontrolling interest and stockholders equity |
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Current and long-term liabilities |
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$ |
8,593 |
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$ |
5,730 |
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Noncontrolling interest in Symphony Dynamo, Inc. |
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9,728 |
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Stockholders equity |
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58,303 |
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74,363 |
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Total liabilities, noncontrolling interest and stockholders equity |
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$ |
76,624 |
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$ |
80,093 |
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