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 expenses.
About HEPLISAV
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.
About Dynavax
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)
(Unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
-------------------- --------------------
2010 2009 2010 2009
--------- --------- --------- ---------
Revenues:
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
Operating expenses:
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
========= ========= ========= =========
Shares used to compute basic
net income (loss) per share
attributable to Dynavax
stockholders 82,012 39,923 68,264 39,906
========= ========= ========= =========
Diluted net income (loss) per
share attributable to Dynavax
stockholders $ (0.34) $ 0.10 $ (0.54) $ 0.23
========= ========= ========= =========
Shares used to compute diluted
net income (loss) per share
attributable to Dynavax
stockholders 82,012 40,064 68,264 39,906
========= ========= ========= =========
DYNAVAX TECHNOLOGIES CORPORATION
RECONCILIATION OF GAAP REVENUES TO PRO FORMA REVENUES
(In thousands)
(Unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
----------------- -----------------
2010 2009 2010 2009
-------- -------- -------- --------
GAAP revenues $ 2,191 $ 15,884 $ 10,535 $ 35,228
ADD:
Collaboration funding incurred
under SDI programs -- 795 -- 1,542
LESS:
Non-cash deferred revenue from
Merck collaboration -- 12,948 -- 28,485
-------- -------- -------- --------
Pro forma revenues (1) $ 2,191 $ 3,731 $ 10,535 $ 8,285
======== ======== ======== ========
(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.
DYNAVAX TECHNOLOGIES CORPORATION
RECONCILIATION OF GAAP OPERATING EXPENSES TO PRO FORMA OPERATING EXPENSES
(In thousands)
(Unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
----------------- -----------------
2010 2009 2010 2009
-------- -------- -------- --------
GAAP operating expenses $ 18,463 $ 13,017 $ 35,758 $ 28,018
LESS:
Stock-based compensation expense 425 667 966 1,186
Amortization of intangible assets 245 245 490 490
-------- -------- -------- --------
Pro forma operating expenses (2) $ 17,793 $ 12,105 $ 34,302 $ 26,342
======== ======== ======== ========
(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)
(Unaudited)
June 30, December 31,
2010 2009
------------ ------------
Assets
Cash and cash equivalents and marketable
securities $ 57,378 $ 36,720
Property and equipment, net 6,324 7,997
Goodwill 2,312 2,312
Other intangible assets, net 789 1,279
Other assets 4,875 2,162
------------ ------------
Total assets $ 71,678 $ 50,470
============ ============
Liabilities and stockholders' equity
Accounts payable $ 1,033 $ 1,686
Accrued liabilities 14,644 7,507
Warrant liability to Holdings 12,029 2,567
Current portion of deferred revenue 1,429 2,718
Noncurrent portion of deferred revenue 16,369 17,083
Long-term note payable to Holdings 10,140 9,342
Long-term contingent liability to Holdings 3,161 3,040
Other long-term liabilities 65 151
Stockholders' equity 12,808 6,376
------------ ------------
Total liabilities and stockholders' equity $ 71,678 $ 50,470
============ ============
