Full Press Release Details
BERKELEY, CA--(Marketwire - July 30, 2010) - Dynavax Technologies Corporation (NASDAQ: DVAX) today reported financial results for the second quarter ended June
30, 2010, including $57.4 million in cash and cash equivalents. This
compared to $30.1 million at March 31, 2010. In April, the Company
completed a financing which resulted in net proceeds of $41 million. The
$13.7 million cash usage for the second quarter primarily reflected
accelerated enrollment and immunization of over 2,400 subjects in the
HEPLISAVTM Phase 3 lot-to-lot consistency and safety study and to a lesser
extent, planned investment in early clinical development of the Company's
universal flu vaccine and autoimmune program.
Total revenues for the second quarter 2010 were $2.2 million, compared to
$15.9 million reported for the second quarter in 2009, of which $13.0
million was non-cash deferred revenue recognized following the termination
of the Merck collaboration.
Total operating expenses for the second quarter 2010 were $18.5 million,
versus $17.3 million reported for the first quarter 2010, driven by
intensified clinical and manufacturing activities for HEPLISAV. Total
operating expenses for the second quarter 2009 were $13.0 million prior to
restarting the HEPLISAV clinical program in September 2009.
One-time events affected the net loss for the first half of 2010 and 2009.
Net loss for the second quarter 2010 was $28.0 million, or $0.34 per share,
which included non-operating expense of $11 million resulting from the
issuance of common stock and warrants to Symphony in connection with the
Company's April 2010 financing. Net income for the second quarter 2009 was
$4.1 million, or $0.10 per share, reflecting the non-cash deferred revenue
of $13 million described above.
The tables included as part of this press release provide a reconciliation
of GAAP revenues and operating expenses to pro forma revenues and operating
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.
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. Future actual operating and
financial results may differ materially 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 and 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. Past financial results are not necessarily
indicative of future financial performance. 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
Dynavax's website at www.dynavax.com is not incorporated by reference in
the Company's current periodic reports with the SEC.
- tables to follow -
DYNAVAX TECHNOLOGIES CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
Three Months Ended Six Months Ended
-------------------- --------------------
--------- --------- --------- ---------
Collaboration revenue $ 1,341 $ 14,596 $ 8,762 $ 32,288
Grant revenue 617 895 1,479 2,034
Service and license revenue 233 393 294 906
--------- --------- --------- ---------
Total revenues 2,191 15,884 10,535 35,228
Research and development 14,045 9,239 26,525 19,571
General and administrative 4,173 3,533 8,743 7,957
Amortization of intangible
assets 245 245 490 490
--------- --------- --------- ---------
Total operating expenses 18,463 13,017 35,758 28,018
--------- --------- --------- ---------
Income (loss) from operations (16,272) 2,867 (25,223) 7,210
Interest income 39 46 41 156
Interest expense (431) (12) (830) (27)
Other income (expense) (11,340) 226 (11,176) (120)
--------- --------- --------- ---------
Net income (loss) (28,004) 3,127 (37,188) 7,219
Add: Losses attributed to
noncontrolling interest in SDI -- 983 -- 1,992
--------- --------- --------- ---------
Net income (loss) attributable
to Dynavax $ (28,004) $ 4,110 $ (37,188) $ 9,211
--------- --------- --------- ---------
Basic net income (loss) per
share attributable to Dynavax
stockholders $ (0.34) $ 0.10 $ (0.54) $ 0.23
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Shares used to compute basic