Durata Therapeutics, Inc. Reports Second Quarter 2013 Financial Results
August 07 2013 - 7:30AM
Durata Therapeutics, Inc. (Nasdaq:DRTX) today announced financial
results for the quarter ended June 30, 2013.
Q2 2013 Highlights and Recent Events
Accomplishments include the following:
- Completed an equity offering in April, resulting in
approximately $54.1 million of net proceeds before deducting costs
payable by us
- Presented new data demonstrating in vitro potency of
dalbavancin against bacterial pathogens at the 23rd Annual ECCMID
Meeting
- Elected Paul A. Friedman, M.D. to the Board of Directors
- Concluded pre-New Drug Application ("NDA") clinical and CMC
meetings with the Food and Drug Administration ("FDA")
- Confirmed process and timeline for NDA submission with the
FDA
"We are pleased to reaffirm the timing of the submission of both
the NDA and the Marketing Authorization Application ("MAA")," said
Paul Edick, Chief Executive Officer of Durata Therapeutics, Inc.
"Based on discussions with the FDA, including pre-NDA meetings in
which both clinical and manufacturing data were discussed, we
intend to submit to the FDA our initial NDA submission in late
September. The MAA submission also remains on track to file with
the European Medicines Agency ("EMA") by year-end." Mr. Edick
continued, "Our cash position following our $54 million equity
raise remains strong and will enable us to successfully launch
dalbavancin in the U.S. in the second half of 2014."
Financial results for the quarter ended June 30,
2013
As of June 30, 2013, we had cash and cash equivalents plus
short-term investments of $83.5 million, compared to $45.4 million
at December 31, 2012. The increase was primarily due to the
Company's equity offering in the second quarter.
Net loss for the three months ended June 30, 2013 (the "2013
Quarter") was $18.8 million, compared to a net loss of $19.2
million for the three months ended June 30, 2012 (the "2012
Quarter").
Research and development expenses for the 2013 Quarter were
$13.2 million, compared to $16.5 million for the 2012 Quarter. The
$3.3 million decrease from the 2012 Quarter to the 2013 Quarter
principally resulted from a decrease of $7.6 million related to
clinical related trial costs as a result of completing our DISCOVER
1 and DISCOVER 2 clinical trials partially offset by an increase of
$3.6 million related to chemistry, manufacturing and control
("CMC") related expenses for the production of active
pharmaceutical ingredient ("API") for future, potential commercial
sale and a $0.5 million increase in costs related to the
preparation of the final study report and NDA submission.
General and administrative expense for the 2013 Quarter was $4.5
million, compared to $2.4 million for the 2012 Quarter. The $2.1
million increase from the 2012 Quarter to the 2013 Quarter
principally resulted from an increase of $1.8 million for personnel
costs and an increase of $0.3 million for insurance and other
operating expenses to support our pre-launch activities and
increased public company compliance requirements.
Conference Call and Webcast Information
The company will host a conference call today, August 7, 2013 at
8:30 AM EDT. 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 12148199). A replay
of the call may be accessed through August 21, 2013 by dialing
800-585-8367 for callers in the U.S. and Canada and 404-537-3406
for international callers (reference Conference ID12148199). The
conference call will also be webcast live on the Investor Relations
section of the Company's website at www.duratatherapeutics.com.
About Dalbavancin
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 these
patients.
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
completed two global Phase 3 clinical trials with its lead product
candidate, dalbavancin, under investigation for the treatment of
patients with acute bacterial skin and skin structure infections
caused by susceptible gram-positive bacteria.
Forward-looking statements
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 timing of the filing of a NDA with the FDA and
the timing of the filing of a MAA with the EMA, the potential
commercialization of dalbavancin and the sufficiency of our cash
reserves. 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 quarterly report on Form 10-Q, 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 |
(in
thousands) |
(Unaudited) |
|
|
|
Assets |
June
30, 2013 |
December
31, 2012 |
Current assets: |
|
|
Cash and cash equivalents |
$ 61,384 |
$ 32,257 |
Short-term investments |
22,095 |
13,094 |
Prepaid expenses and other
current assets |
1,857 |
5,844 |
Total current assets |
85,336 |
51,195 |
Acquired in process research and
development |
15,292 |
15,292 |
Goodwill |
5,811 |
5,811 |
Property and equipment, net |
1,009 |
981 |
Restricted cash |
1,145 |
852 |
Deferred charge |
11,235 |
12,417 |
Other assets |
576 |
— |
Total assets |
$ 120,404 |
$ 86,548 |
Liabilities and Stockholders'
Equity |
|
|
Current liabilities: |
|
|
Accounts payable |
$ 5,228 |
$ 8,618 |
Accrued expenses |
8,597 |
10,602 |
Current portion of long-term
debt |
1,205 |
— |
Income taxes payable |
— |
2,281 |
Total current liabilities |
15,030 |
21,501 |
Long-term debt (less unamortized debt
discount of $1,443 at June 30, 2013) |
17,352 |
— |
Non-current income tax payable |
1,412 |
1,117 |
Contingent consideration |
20,409 |
19,836 |
Accrued interest liability |
1,190 |
— |
Other liabilities |
318 |
222 |
Total liabilities |
55,711 |
42,676 |
Total stockholders' equity |
64,693 |
43,872 |
Total liabilities and stockholders'
equity |
$ 120,404 |
$ 86,548 |
|
|
DURATA THERAPEUTICS,
INC. AND SUBSIDIARIES |
(A Development Stage
Company) |
Consolidated Statement
of Operations |
(in thousands, except
share and per share data) |
(Unaudited) |
|
|
|
|
|
Period from |
|
|
|
|
|
inception |
|
|
|
|
|
(November 4, |
|
Three month period ended |
Six month period ended |
2009) to |
|
June
30, |
June
30, |
June 30, |
|
2013 |
2012 |
2013 |
2012 |
2013 |
Operating expenses: |
|
|
|
|
|
Research and development
expenses |
$ 13,179 |
$ 16,528 |
$ 24,271 |
$ 23,299 |
$ 111,115 |
General and administrative
expenses |
4,514 |
2,392 |
8,565 |
3,613 |
26,347 |
Acquisition related charges,
net |
289 |
272 |
573 |
540 |
9,117 |
Operating loss |
17,982 |
19,192 |
33,409 |
27,452 |
146,579 |
Other (income) expense |
|
|
|
|
|
Interest expense |
654 |
-- |
762 |
-- |
762 |
Interest income |
(11) |
(4) |
(26) |
(7) |
(85) |
Total other (income)
expense |
643 |
(4) |
736 |
(7) |
677 |
Loss before income tax expense (benefit) |
18,625 |
19,188 |
34,145 |
27,445 |
147,256 |
Income tax expense (benefit) |
210 |
-- |
458 |
-- |
(5,353) |
Net loss |
$ (18,835) |
$ (19,188) |
$ (34,603) |
$ (27,445) |
$ (141,903) |
|
|
|
|
|
|
Net loss per common share – Basic and
Diluted |
$ (0.75) |
$ (260.25) |
$ (1.59) |
$ (402.94) |
|
Weighted average common shares – Basic and
Diluted |
25,169,543 |
73,727 |
21,787,331 |
68,113 |
|
CONTACT: Investor Relations and Public Affairs Contact
Allison Wey
Durata Therapeutics, Inc.
Vice President, Investor Relations and Public Affairs
(312) 219-7017
awey@duratatherapeutics.com
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