Durata Therapeutics, Inc. Reports Full-Year 2012 Financial Results
Entered Into a $20 Million Debt Facility
CHICAGO, March 8, 2013 (GLOBE NEWSWIRE) -- Durata Therapeutics, Inc.
(Nasdaq:DRTX) today announced financial results for the year ended December
"2012 was a great year for Durata. We accomplished many things from a
clinical, regulatory and organizational perspective that position us well for
a successful 2013 and beyond," said Paul Edick, Chief Executive Officer of
Durata Therapeutics, Inc. "Our financial results reflect our increase in
spending as we were concluding our studies and preparing for submission to the
FDA and potential commercialization of dalbavancin for treatment of acute
bacterial skin and skin structure infections (ABSSSI)."
2012 Highlights and Recent Events
Our significant accomplishments include the following:
*Completed enrollment and closed our two Phase 3 clinical trials of
dalbavancin, DISCOVER 1 and DISCOVER 2. Both studies met their primary and
secondary endpoints, based on preliminary top-line data.
*Received Qualified Infectious Disease Product (QIDP) designation for
dalbavancin from the FDA, which provides Durata priority review by the
FDA, eligibility for "fast-track" status, and extension of statutory
exclusivity periods for an additional five years upon FDA approval of the
product for the treatment of ABSSSI.
*Completed our initial public offering, resulting in approximately $71.3
million of net proceeds.
*Entered into a $20.0 million debt facility on March 5, 2013 with Oxford
Finance LLC. Net proceeds are expected to be received by the end of March
2013 and used for working capital purposes.
Financial results for the year ended December 31, 2012
As of December 31, 2012, we had cash and cash equivalents plus short-term
investments of $45.3 million, compared to $11.5 million at December 31, 2011.
Net loss for the year ended December 31, 2012 (the "2012 Year") was $62.5
million, compared to a net loss of $33.0 million for the year ended December
31, 2011 (the "2011 Year").
Research and development expense for the 2012 Year was $51.7 million, compared
to $30.1 million for the 2011 Year. The $21.6 million increase from the 2011
Year to the 2012 Year principally resulted from an increase of $22.8 million
in contract research organization and other clinical trial expenses, including
consulting, and an increase of $2.1 million for personnel costs to support our
studies, partially offset by a decrease of $3.3 million related to chemistry,
manufacturing and control related expenses in the 2012 Year due to the
decrease in the acquisition of comparator products for use in our recently
completed Phase 3 clinical trials.
General and administrative expense for the 2012 Year was $9.8 million,
compared to $4.3 million for the 2011 Year. The $5.5 million increase from the
2011 Year to the 2012 Year principally resulted from an increase of $2.9
million for personnel costs, an increase of $1.6 million in legal and
consulting fees and an increase of $1.0 million for insurance and other
operating expenses to support our pre-launch activities and increased
Conference Call and Webcast Information
The company will host a conference call today, March 8, 2013 at 8:30 AM EST.
To access the call, please dial 866-632-4021 for participants in the U.S. or
Canada and 404-991-3968 for international callers (reference Conference ID
19456362). A replay of the call may be accessed through March 22, 2013 by
dialing 800-585-8367 for callers in the U.S. and Canada and 404-537-3406 for
international callers (reference Conference ID 19456362). The conference call
will also be webcast live at
The webcast will as well be available on the Investor Relations section of the
Company's website at www.duratatherapeutics.com.
Dalbavancin is an intravenous antibiotic product candidate under investigation
for once-weekly dosing, which we believe may facilitate the treatment of
patients with ABSSSI in both the in-patient and out-patient settings,
potentially reducing the length of a patient's hospital stay or avoiding
hospital admission altogether, with an impact on the overall cost of care for
About Durata Therapeutics
Durata Therapeutics is a pharmaceutical company focused on the development and
commercialization of novel therapeutics for patients with infectious diseases
and acute illnesses. Durata has now completed two global Phase 3 clinical
trials with its lead product candidate, dalbavancin, for the treatment of
patients with ABSSSI.
The Durata Therapeutics, Inc. logo is available at
Statements contained in this press release contain forward-looking statements
that involve substantial risks and uncertainties. All statements, other than
statements of historical facts, contained in this press release, including
statements regarding our strategy, future operations, future financial
position, future revenues, projected costs, prospects, plans and objectives of
management, are forward-looking statements. The words "anticipate," "believe,"
"estimate," "expect," "intend," "may," "plan," "predict," "project," "target,"
"potential," "will," "would," "could," "should," "continue," and similar
expressions are intended to identify forward-looking statements, although not
all forward-looking statements contain these identifying words.
Forward-looking statements in this press release include statements about the
preliminary top-line results of our completed Phase 3 clinical trials, the
timing of the filing of a NDA with the FDA and a MAA with the EMA, potential
commercialization of dalbavancin, the success of Durata in 2013 and beyond and
receipt of net proceeds from our debt facility with Oxford Finance LLC. Actual
results may differ materially from those indicated by these forward-looking
statements as a result of various important factors, including those discussed
in the "Risk Factors" section of our most recent annual report on Form 10-K,
which is on file with the SEC and is also available on our website. In
addition, any forward-looking statements represent our views only as of today
and should not be relied upon as representing our views as of any subsequent
date. While we may elect to update these forward-looking statements at some
point in the future, we specifically disclaim any obligation to do so, even if
our views change. Therefore, you should not rely on these forward-looking
statements as representing our views as of any date subsequent to today.
DURATA THERAPEUTICS, INC. AND SUBSIDIARIES
(A Development Stage Company)
Consolidated Balance Sheet
Assets December 31, December 31,
Cash and cash equivalents $ 32,257 $ 11,485
Short-term investments 13,094 —
Prepaid expenses and other current assets 5,844 997
Total current assets 51,195 12,482
Acquired in process research and development 15,292 15,292
Goodwill 5,811 5,811
Property and equipment, net 981 —
Restricted cash 852 —
Deferred charge 12,417 —
Other assets — 40
Total assets $ 86,548 $ 33,625
Liabilities, Redeemable Preferred Stock and
Accounts payable $ 8,618 $ 1,957
Accrued expenses 10,602 1,369
Income taxes payable 2,281 —
Total current liabilities 21,501 3,326
Non-current income tax payable 1,117 —
Contingent consideration 19,836 18,739
Other liabilities 222 —
Total liabilities 42,676 22,065
Redeemable portion - Series A Convertible Preferred — 6,000
Total stockholders' equity 43,872 5,560
Total liabilities, redeemable preferred stock $ 86,548 $ 33,625
DURATA THERAPEUTICS, INC. AND SUBSIDIARIES
(A Development Stage Company)
Consolidated Statement of Operations
(in thousands, except share and per share data)
Year ended December 31, December 31,
2012 2011 2012
Research and development expenses $ 51,695 $ 30,133 $ 86,844
General and administrative expenses 9,788 4,305 17,782
Acquisition related charges, net 1,097 1,121 8,544
Operating loss 62,580 35,559 113,170
Interest income (41) (15) (59)
Loss before income tax benefit 62,539 35,544 113,111
Income tax benefit -- (2,511) (5,811)
Net loss $ (62,539) $ (33,033) $ (107,300)
Net loss attributable to common $ (62,539) $ (33,033) $ (107,300)
Net loss per common share – Basic and $ (7.48) $ (551.51)
Weighted-average common shares – Basic 8,364,432 59,896
CONTACT: Investor Relations and Public Affairs Contact
Durata Therapeutics, Inc.
Vice President, Investor Relations and Public Affairs
Media Relations Contact
White Oak Communications, Inc.
Durata Therapeutics, Inc. Logo
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