Full Press Release Details
BERKELEY, CA--(Marketwire - May 6, 2010) - Dynavax Technologies Corporation (NASDAQ: DVAX) today reported financial results for the first quarter ended March
31, 2010, including $30.1 million in cash and cash equivalents. Total cash
for the first quarter 2010 does not include $41 million in net proceeds
from the public offering completed on April 16, 2010.
"With the completion of the recent financing, we are poised to achieve our
most critical goals, including completion of the Phase 3 study required for
submitting our BLA for HEPLISAV , initiating clinical development for
our Universal Flu and TLR autoimmune products, and positioning hepatitis B
and C therapeutics for out-licensing," noted Dino Dina, M.D., President and
The tables included as part of this press release provide a reconciliation
of GAAP revenues and operating expenses to pro forma revenues and operating
Dynavax will webcast a conference call today at 4:30 p.m. EDT (1:30 p.m.
PDT). The live and archived webcast can be accessed by visiting the
investor relations section of the Company's Web site at
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, including statements relating to
clinical trials and BLA submission. Actual results may differ materially
from those set forth in this press release 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, 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. 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)
--------------------
Collaboration revenue $ 7,421 $ 17,692
Grant revenue 862 1,139
Service and license revenue 61 513
Total revenues 8,344 19,344
Research and development 12,480 10,332
General and administrative 4,570 4,424
Amortization of intangible assets 245 245
Total operating expenses 17,295 15,001
Loss from operations (8,951) 4,343
Interest income 2 110
Interest expense (399) (15)
Other income (expense) 164 (346)
Net income (loss) (9,184) 4,092
Add: Losses attributed to noncontrolling interest in
Net income (loss) attributable to Dynavax $ (9,184) $ 5,101
Basic and diluted net income (loss) per share
attributable to Dynavax common stockholders $ (0.17) $ 0.13
Shares used to compute basic net income (loss) per
share attributable to Dynavax common stockholders 54,364 39,889
DYNAVAX TECHNOLOGIES CORPORATION
RECONCILIATION OF GAAP REVENUES TO PRO FORMA REVENUES
---------------------
---------- ----------
GAAP revenues $ 8,344 $ 19,344
Collaboration funding incurred under SDI programs -- 747
Non-cash deferred revenue from Merck collaboration -- 15,537
---------- ----------
Pro forma revenues(1) $ 8,344 $ 4,554
========== ==========
(1) These pro forma amounts are intended to illustrate the Company's
revenues including collaboration funding provided for the SDI programs
and excluding certain non-cash items. 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 operating programs. 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.