Dynavax Announces First Quarter 2008 Financial Results
Revenues Increase for Quarter, Per Share Net Loss Narrows
BERKELEY, Calif. (Business Wire EON) April 29, 2008 --
Dynavax Technologies Corporation (Nasdaq: DVAX) today reported financial
results for the first quarter ended March 31, 2008.
As of March 31, 2008, Dynavax reported cash, cash equivalents,
marketable securities and investments held by Symphony Dynamo, Inc.
(SDI) totaling $73.2 million. This compares to $88.2 million at December
31, 2007.
For the first quarter 2008, total revenues were $6.3 million, compared
to $2.0 million reported for the first quarter in 2007. The increase in
revenues for the first quarter reflects research and development funding
from Merck & Co. Inc. for HEPLISAVTM, our
hepatitis B vaccine product candidate. The reported revenues do not
include collaboration funding from Symphony Dynamo Inc. (SDI) for cancer
and HCV clinical activities. On a pro forma basis, including the
collaboration funding from SDI, revenues were $7.8 million for the first
quarter 2008, compared to $5.5 million for the first quarter 2007.
The company indicated that HEPLISAV had been placed on clinical hold by
the U.S. Food & Drug Administration (FDA) prior to the close of the
quarter, and is working with its commercialization partner Merck to
respond in a timely manner.
For the first quarter 2008, total operating expenses were $19.9 million
compared to $18.1 million for the first quarter 2007. The increase in
operating expenses resulted primarily from overall organizational growth
in the U.S. to support the Company’s product
pipeline and the expansion of our manufacturing capabilities in Europe
related to potential commercialization of HEPLISAV. The operating
expenses included non-cash charges for stock-based compensation and
amortization of intangible assets. Excluding the non-cash charges, pro
forma operating expenses were $19.0 million for the first quarter
2008 compared to $17.0 million for the first quarter 2007.
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.
The net loss of $12.4 million, or $0.31 per share, reported for the
first quarter 2008 was less than the net loss of $13.1 million, or $0.33
per share, for the same period in 2007. For the first quarter, the
improvement in net loss reflected the increase in revenues, in
particular, revenue associated with the Merck collaboration.
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 partnered with Merck & Co., Inc.; TOLAMBATM,
a ragweed allergy immunotherapy in Phase 2; a therapy for metastatic
colorectal cancer in Phase 1; and a therapy for hepatitis B in Phase 1.
Our preclinical asthma and COPD program is partnered with AstraZeneca.
The NIH partially funds our preclinical work on a vaccine for influenza.
SDI funds our colorectal cancer and hepatitis C therapeutic programs,
and Deerfield Management has committed funding for our allergy programs.
While Deerfield, 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.
Forward-looking Statements
This press release contains "forward-looking statements," including
statements related to the clinical status of HEPLISAV, the timing of
discussions with and responses to the FDA regarding the current clinical
hold and whether or not further clinical development will be permitted.
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, initiation and
completion of clinical trials, 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; achieving our Merck
collaborative agreement objectives and obtaining regulatory approval for
HEPLISAV; the scope and validity of patent protection and the
possibility of 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 Annual
Report on Form 10-K. We undertake no obligation to revise or update
information herein to reflect events or circumstances in the future,
even if new information becomes available.
|
DYNAVAX TECHNOLOGIES CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(Unaudited)
|
|
|
|
|
|
Three Months Ended
March 31,
|
|
|
|
2008
|
|
|
|
2007
|
|
|
Revenues:
|
|
|
|
|
Collaboration revenue
|
$
|
5,774
|
|
|
$
|
747
|
|
|
Grant revenue
|
|
324
|
|
|
|
1,128
|
|
|
Service and license revenue
|
|
216
|
|
|
|
109
|
|
|
Total revenues
|
|
6,314
|
|
|
|
1,984
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
Research and development (2)
|
|
15,120
|
|
|
|
13,632
|
|
|
General and administrative (3)
|
|
4,571
|
|
|
|
4,180
|
|
|
Amortization of intangible assets
|
|
245
|
|
|
|
251
|
|
|
Total operating expenses (1)
|
|
19,936
|
|
|
|
18,063
|
|
|
|
|
|
|
|
Loss from operations
|
|
(13,622
|
)
|
|
|
(16,079
|
)
|
|
|
|
|
|
|
Interest and other income, net
|
|
971
|
|
|
|
1,001
|
|
|
Interest expense
|
|
(1,344
|
)
|
|
|
(28
|
)
|
|
|
|
|
|
|
Loss including noncontrolling interest in Symphony Dynamo, Inc.
|
|
(13,995
|
)
|
|
|
(15,106
|
)
|
|
|
|
|
|
|
Amount attributed to noncontrolling interest in Symphony Dynamo, Inc.
|
|
1,566
|
|
|
|
2,016
|
|
|
|
|
|
|
|
Net loss
|
$
|
(12,429
|
)
|
|
$
|
(13,090
|
)
|
|
|
|
|
|
|
Basic and diluted net loss per share
|
$
|
(0.31
|
)
|
|
$
|
(0.33
|
)
|
|
Shares used to compute basic and diluted net loss per share
|
|
39,785
|
|
|
|
39,727
|
|
(1) Total operating expenses excluding non-cash stock-based compensation
charges were $19.3 million and $17.3 million for the first quarter ended
March 31, 2008 and 2007, respectively.
(2) Research and development expenses included non-cash stock-based
compensation charges of $0.2 million for both the first quarters ended
March 31, 2008 and 2007.
(3) General and administrative expenses included non-cash stock-based
compensation charges of $0.5 million and $0.6 million for the first
quarter ended March 31, 2008 and 2007, respectively.
|
DYNAVAX TECHNOLOGIES CORPORATION
RECONCILIATION OF GAAP REVENUES TO PRO FORMA REVENUES
(In thousands)
(Unaudited)
|
|
|
|
|
|
Three Months Ended
March 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
|
|
|
GAAP revenues
|
$
|
6,314
|
|
$
|
1,984
|
|
ADD:
Collaboration funding incurred under SDI programs
|
|
1,531
|
|
|
3,496
|
|
Pro forma revenues (1)
|
$
|
7,845
|
|
$
|
5,480
|
(1) These pro forma amounts are intended to illustrate the Company’s
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 Company’s
consolidated statement of operations, but would have been reported as
revenue if SDI’s 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 Company’s
revenues because it provides investors the ability to evaluate the
Company’s 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)
|
|
|
|
|
|
Three Months Ended
March 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
|
|
|
GAAP operating expenses
|
$
|
19,936
|
|
$
|
18,063
|
|
LESS:
Stock-based compensation expense
|
|
661
|
|
|
808
|
|
Amortization of intangible assets
|
|
245
|
|
|
251
|
|
Pro forma operating expenses (2)
|
$
|
19,030
|
|
$
|
17,004
|
(2) These pro forma amounts are intended to illustrate the Company’s
operating expenses excluding certain non-cash charges in accordance with
the financial statements that management uses to evaluate the Company’s
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.
|
DYNAVAX TECHNOLOGIES CORPORATION
SELECTED BALANCE SHEET DATA
(In thousands)
|
|
|
|
|
|
|
|
March 31,
|
|
December 31,
|
|
|
|
2008
|
|
|
2007
|
|
Assets
|
(unaudited)
|
|
|
|
Cash and cash equivalents and marketable securities (1)
|
$
|
73,161
|
|
$
|
88,248
|
|
Property and equipment, net
|
|
10,268
|
|
|
7,314
|
|
Goodwill
|
|
2,312
|
|
|
2,312
|
|
Other intangible assets, net
|
|
2,994
|
|
|
3,239
|
|
Other assets
|
|
16,597
|
|
|
19,336
|
|
Total assets
|
$
|
105,332
|
|
$
|
120,449
|
|
|
|
|
|
|
Liabilities, noncontrolling interest and stockholders’
equity
|
|
|
|
|
Current liabilities
|
$
|
16,547
|
|
$
|
19,904
|
|
Noncurrent portion of deferred revenue
|
|
40,127
|
|
|
40,792
|
|
Liability from Program Option exercised under the SDI collaboration
|
|
15,000
|
|
|
15,000
|
|
Other long-term liabilities
|
|
7,616
|
|
|
5,622
|
|
Noncontrolling interest in Symphony Dynamo, Inc.
|
|
6,775
|
|
|
8,341
|
|
Stockholders’ equity
|
|
19,267
|
|
|
30,790
|
|
Total liabilities, noncontrolling interest and stockholders’
equity
|
$
|
105,332
|
|
$
|
120,449
|
(1) These amounts include investments held by Symphony Dynamo, Inc. of
$29.5 million and $31.6 million as of March 31, 2008 and December 31,
2007, respectively.
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