BERKELEY, CA--(Marketwire - May 06, 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 CEO.
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.
Conference Call
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 http://investors.dynavax.com/newsevents.cfm.
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, 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)
(Unaudited)
Three Months Ended
March 31,
--------------------
2010 2009
--------- ---------
Revenues:
Collaboration revenue $ 7,421 $ 17,692
Grant revenue 862 1,139
Service and license revenue 61 513
--------- ---------
Total revenues 8,344 19,344
Operating expenses:
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
SDI -- 1,009
--------- ---------
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
(In thousands)
(Unaudited)
Three Months Ended
March 31,
---------------------
2010 2009
---------- ----------
GAAP revenues $ 8,344 $ 19,344
ADD:
Collaboration funding incurred under SDI programs -- 747
LESS:
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.
DYNAVAX TECHNOLOGIES CORPORATION
RECONCILIATION OF GAAP OPERATING EXPENSES TO PRO FORMA OPERATING EXPENSES
(In thousands)
(Unaudited)
Three Months Ended
March 31,
---------------------
2010 2009
---------- ----------
GAAP operating expenses $ 17,295 $ 15,001
LESS:
Stock-based compensation expense 541 519
Amortization of intangible assets 245 245
---------- ----------
Pro forma operating expenses(2) $ 16,509 $ 14,237
========== ==========
(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)
March 31, December 31,
2010 2009
----------- ------------
Assets
Cash and cash equivalents and marketable
securities $ 30,080 $ 36,720
Property and equipment, net 7,199 7,997
Goodwill 2,312 2,312
Other intangible assets, net 1,034 1,279
Other assets 3,659 2,162
----------- ------------
Total assets $ 44,284 $ 50,470
=========== ============
Liabilities and stockholders' equity
Accounts payable $ 1,091 $ 1,686
Accrued liabilities 10,571 7,507
Warrant liability to Holdings 2,315 2,567
Current portion of deferred revenue 2,384 2,718
Noncurrent portion of deferred revenue 16,726 17,083
Long-term note payable to Holdings 9,741 9,342
Long-term contingent liability to Holdings 3,109 3,040
Other long-term liabilities 146 151
Stockholders' equity (deficit) (1,799) 6,376
----------- ------------
Total liabilities and stockholders' equity $ 44,284 $ 50,470
=========== ============
