Dynavax Announces Second Quarter 2008 Financial Results
Revenues Increase for Quarter, Per Share Net Loss Narrows
BERKELEY, Calif. (Business Wire EON/PRWEB ) August 5, 2008 --
Dynavax Technologies Corporation (Nasdaq:DVAX) today reported financial
results for the second quarter and six months ended June 30, 2008.
As of June 30, 2008, Dynavax reported cash, cash equivalents, marketable
securities and investments held by Symphony Dynamo, Inc. (SDI) totaling
$63.1 million. This compares to $88.2 million at December 31, 2007.
For the second quarter 2008, total revenues were $10.0 million, compared
to $1.8 million reported for the second quarter in 2007. Revenues for
the six months ended 2008 were $16.3 million, compared to $3.8 million
for the same period in 2007. The increase in revenues for the second
quarter and year-to-date reflects research and development funding under
our collaboration with Merck & Co. Inc. (Merck) 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 $11.4 million and $19.3
million for the three and six months ended June 30, 2008, respectively,
compared to $4.9 million and $10.4 million for the same periods in 2007.
For the second quarter 2008, total operating expenses were $16.6
million, compared to $23.6 million for the second quarter in 2007.
Operating expenses for the six months ended 2008 were $36.5 million,
compared to $41.7 million for the same period in 2007. The decline in
operating expenses for the second quarter and year-to-date resulted
primarily from a reduction in clinical development costs. The operating
expenses in 2007 also included a one-time license payment for the
commercialization of HEPLISAV. Excluding the one-time and other non-cash
charges for stock-based compensation and amortization of intangible
assets, pro forma operating expenses were $15.6 million and $34.6
million for the three and six months ended June 30, 2008, respectively,
compared to $17.7 million and $34.7 million for the same periods in 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 $6.1 million, or $0.15 per share, reported for the
second quarter 2008 improved from the net loss of $17.7 million, or
$0.45 per share, for the same period in 2007. The net loss of $18.5
million, or $0.47 per share, reported for the six months ended 2008 was
also significantly less than the net loss of $30.8 million, or $0.78 per
share, for the same period in 2007. For the second quarter and
year-to-date, the improvement in net loss reflected the increase in
revenues, in particular, revenue associated with the Merck collaboration.
Webcast Today
Dynavax will webcast a discussion of the HEPLISAV Phase 3 data announced
today along with the company’s second quarter
2008 financial results on Tuesday, August 5, 2008 at 4:30 p.m. Eastern
Daylight Time / 1:30 p.m. Pacific Daylight Time. The webcast can be
accessed on Dynavax’s website at http://investors.dynavax.com/events.cfm.
A telephonic replay of the discussion will be available through August
19, 2008 by dialing 1-888-203-1112, access code: 4643391. International
callers can dial 1-719-457-0820, access code: 4643391.
About Dynavax
Dynavax Technologies Corporation discovers, develops, and intends to
commercialize innovative TLR9 agonist-based products to treat and
prevent infectious diseases, allergy, 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 clinical product candidates include: HEPLISAV,
a hepatitis B vaccine partnered with Merck & Co., Inc.; a therapy for
metastatic colorectal cancer; and therapies for hepatitis B and C. Our
preclinical asthma and COPD program is partnered with AstraZeneca. The
NIH partially funds our preclinical universal influenza vaccine program
that is being coordinated with Novartis. Symphony Dynamo Inc. (SDI)
funds our colorectal cancer and hepatitis C therapeutic programs. 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.
Forward-looking Statements
This press release contains forward-looking statements that are subject
to a number of risks and uncertainties. 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, resuming development and obtaining regulatory approval for
HEPLISAV; continuation of our third party collaboration and funding
arrangements; 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 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.
|
DYNAVAX TECHNOLOGIES CORPORATION
|
|
CONSOLIDATED STATEMENTS OF OPERATIONS
|
|
(In thousands, except per share amounts)
|
|
|
(Unaudited)
|
|
|
|
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
|
|
|
2008
|
|
|
|
2007
|
|
|
|
2008
|
|
|
|
2007
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
Collaboration revenue
|
$
|
7,701
|
|
|
$
|
752
|
|
|
$
|
13,475
|
|
|
$
|
1,499
|
|
|
|
Grant revenue
|
|
1,122
|
|
|
|
587
|
|
|
|
1,446
|
|
|
|
1,715
|
|
|
|
Service and license revenue
|
|
1,155
|
|
|
|
461
|
|
|
|
1,371
|
|
|
|
570
|
|
|
Total revenues
|
|
9,978
|
|
|
|
1,800
|
|
|
|
16,292
|
|
|
|
3,784
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
Research and development (2)
|
|
12,946
|
|
|
|
19,164
|
|
|
|
28,066
|
|
|
|
32,796
|
|
|
|
General and administrative (3)
|
|
3,420
|
|
|
|
4,206
|
|
|
|
7,991
|
|
|
|
8,386
|
|
|
|
Amortization of intangible assets
|
|
245
|
|
|
|
252
|
|
|
|
490
|
|
|
|
503
|
|
|
Total operating expenses (1)
|
|
16,611
|
|
|
|
23,622
|
|
|
|
36,547
|
|
|
|
41,685
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
(6,633
|
)
|
|
|
(21,822
|
)
|
|
|
(20,255
|
)
|
|
|
(37,901
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other income, net
|
|
405
|
|
|
|
1,118
|
|
|
|
1,376
|
|
|
|
2,119
|
|
|
Interest expense
|
|
(1,340
|
)
|
|
|
(37
|
)
|
|
|
(2,684
|
)
|
|
|
(65
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Loss including noncontrolling interest in Symphony Dynamo, Inc.
(SDI).
|
|
(7,568
|
)
|
|
|
(20,741
|
)
|
|
|
(21,563
|
)
|
|
|
(35,847
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Amount attributed to noncontrolling interest in SDI
|
|
1,489
|
|
|
|
3,037
|
|
|
|
3,055
|
|
|
|
5,053
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
$
|
(6,079
|
)
|
|
$
|
(17,704
|
)
|
|
$
|
(18,508
|
)
|
|
$
|
(30,794
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share
|
$
|
(0.15
|
)
|
|
$
|
(0.45
|
)
|
|
$
|
(0.47
|
)
|
|
$
|
(0.78
|
)
|
|
Shares used to compute basic and diluted net loss per share
|
|
39,806
|
|
|
|
39,741
|
|
|
|
39,795
|
|
|
|
39,734
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
Total operating expenses excluding non-cash stock-based
compensation charges are $15.8 million and $35.1 million for the
three and six months ended June 30, 2008, respectively. 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.
|
|
(2)
|
Research and development expenses included non-cash stock-based
compensation charges of $0.4 million and $0.6 million for the
three and six months ended June 30, 2008, respectively. 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.
|
|
(3)
|
General and administrative expenses included non-cash stock-based
compensation charges of $0.4 million and $0.9 million for the
three and six months ended June 30, 2008, respectively. 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.
|
|
DYNAVAX TECHNOLOGIES CORPORATION
|
|
RECONCILIATION OF GAAP REVENUES TO PRO FORMA REVENUES
|
|
(In thousands)
|
|
(Unaudited)
|
|
|
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
|
|
2008
|
|
2007
|
|
2008
|
|
2007
|
|
|
|
|
|
|
|
|
|
|
|
GAAP revenues
|
$ 9,978
|
|
$ 1,800
|
|
$ 16,292
|
|
$ 3,784
|
|
ADD:
Collaboration funding incurred under SDI programs
|
1,432
|
|
3,136
|
|
2,963
|
|
6,632
|
|
Pro forma revenues (1)
|
$ 11,410
|
|
$ 4,936
|
|
$ 19,255
|
|
$ 10,416
|
|
|
|
|
|
|
|
|
|
|
|
(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
June 30,
|
|
Six Months Ended
June 30,
|
|
|
|
2008
|
|
2007
|
|
2008
|
|
2007
|
|
|
|
|
|
|
|
|
|
|
|
GAAP operating expenses
|
$ 16,611
|
|
$ 23,622
|
|
$ 36,547
|
|
$ 41,685
|
|
LESS:
Stock-based compensation expense
|
775
|
|
689
|
|
1,436
|
|
1,497
|
|
Licensing fee
|
—
|
|
5,000
|
|
—
|
|
5,000
|
|
Amortization of intangible assets
|
245
|
|
252
|
|
490
|
|
503
|
|
Pro forma operating expenses (2)
|
$ 15,591
|
|
$ 17,681
|
|
$34,621
|
|
$ 34,685
|
|
|
|
|
|
|
|
|
|
|
|
(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)
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
December 31,
|
|
|
|
2008
|
|
2007
|
|
Assets
|
(unaudited)
|
|
|
|
|
Cash and cash equivalents and marketable securities (1)
|
$
|
63,115
|
|
$
|
88,248
|
|
|
Property and equipment, net
|
|
11,165
|
|
|
7,314
|
|
|
Goodwill
|
|
2,312
|
|
|
2,312
|
|
|
Other intangible assets, net
|
|
2,749
|
|
|
3,239
|
|
|
Other assets
|
|
17,597
|
|
|
19,336
|
|
Total assets
|
$
|
96,938
|
|
$
|
120,449
|
|
|
|
|
|
|
|
Liabilities, noncontrolling interest and stockholders’
equity
|
|
|
|
|
|
Current liabilities
|
$
|
15,442
|
|
$
|
19,904
|
|
|
Noncurrent portion of deferred revenue
|
|
39,785
|
|
|
40,792
|
|
|
Liability from Program Option exercised under the SDI collaboration
|
|
15,000
|
|
|
15,000
|
|
|
Other long-term liabilities
|
|
7,611
|
|
|
5,622
|
|
|
Noncontrolling interest in SDI.
|
|
5,286
|
|
|
8,341
|
|
|
Stockholders’ equity
|
|
13,814
|
|
|
30,790
|
|
Total liabilities, noncontrolling interest and stockholders’
equity
|
$
|
96,938
|
|
$
|
120,449
|
|
|
|
|
|
|
|
(1)
|
These amounts include investments held by SDI of $28.0 million and
$31.6 million as of June 30, 2008 and December 31, 2007,
respectively.
|
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