Durata Therapeutics, Inc. Reports Fourth Quarter and Full-Year 2013 Financial Results
March 14 2014 - 7:00AM
Durata Therapeutics, Inc. (Nasdaq:DRTX) today announced its fourth
quarter and full year 2013 financial results.
"2013 was a year of incredible achievement for Durata, including
data presentations of our DISCOVER programs, accepted regulatory
submissions of dalbavancin in the U.S. and E.U., and activities to
prepare for commercialization. In addition, we strengthened our
balance sheet with equity and debt financings that give us
operational flexibility," said Paul R. Edick, Chief Executive
Officer of Durata Therapeutics. "2014 looks to be an exciting year
for Durata as we continue to build an organization focused on the
goal of increasing patient well-being while simultaneously
improving efficiency of health care delivery."
2013 Highlights and Recent Events
Our significant accomplishments include the following:
- We released and presented results from our DISCOVER 1 and
DISCOVER 2 Phase 3 clinical trials ("DISCOVER trials"), which
showed that dalbavancin met its primary and secondary endpoints of
early response, measured at 48 to 72 hours of therapy, and clinical
success at the end of treatment in patients with very large skin
lesions and high frequencies of fever and systemic inflammatory
response syndrome;
- In September 2013, we submitted our new drug application
("NDA") to the U.S. Food and Drug Administration ("FDA") seeking
approval for the marketing and sale of dalbavancin for the
treatment of patients with acute bacterial skin and skin structure
infections ("ABSSSI") caused by susceptible Gram-positive
microorganisms, including methicillin resistant Staphylococcus
aureus ("MRSA"), and on November 25, 2013, the FDA accepted our NDA
for priority review with an action date of May 26, 2014;
- We submitted a marketing authorization application ("MAA") to
the European Medicines Agency ("EMA") in November 2013, and on
December 20, 2013, the EMA accepted our MAA for review;
- On April 17, 2013, we completed a public offering of common
stock, resulting in approximately $54.1 million in net proceeds,
after underwriting discounts and prior to offering expenses payable
by us;
- In October 2013, we and our subsidiaries entered into a credit
agreement with PDL BioPharma, Inc. ("PDL"), which provides for up
to $70.0 million in debt financing. We used the first funding
tranche of $25.0 million to repay amounts owed to Oxford Finance
LLC ("Oxford") under our former loan agreement with Oxford, with
the remaining funds available for working capital
purposes. Upon FDA approval of dalbavancin prior to December
31, 2014, another $15.0 million will be funded to us within five
days of such approval. In addition, we may borrow up to $30.0
million, at our option, for up to nine months following FDA
approval.
Full Year 2013 Financial Results
As of December 31, 2013, we had cash and cash equivalents plus
short-term investments of $59.7 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 of 2013.
Net loss for the year ended December 31, 2013 (the "2013 Year")
was $62.1 million, compared to a net loss of $62.5 million for the
year ended December 31, 2012 (the "2012 Year").
Research and development expenses for the 2013 Year were $37.3
million, compared to $51.7 million for the 2012 Year. The $14.4
million decrease from the 2012 Year to the 2013 Year is primarily
due to the decrease in clinical trial activities following the
completion of the DISCOVER trials and is partially offset by higher
costs associated with the manufacturing of product for the
anticipated commercialization.
General and administrative expense for the 2013 Year was $18.6
million, compared to $9.8 million for the 2012 Year. The $8.8
million increase from the 2012 Year to the 2013 Year related to our
continued expansion efforts in preparation for the anticipated
commercial launch of dalbavancin and increased cost associated with
operating as a public company.
Conference Call and Webcast Information
The company will host a conference call today, March 14, 2014,
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 31699772). A replay
of the call may be accessed through March 28, 2014 by dialing
800-585-8367 for callers in the U.S. and Canada and 404-537-3406
for international callers (reference Conference ID 31699772). 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 patient well-being and healthcare efficiencies,
potential regulatory approval for dalbavancin and the ability to
obtain additional funds from PDL. 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 |
(in
thousands) |
|
|
|
|
December 31, |
December 31, |
Assets |
2013 |
2012 |
Current assets: |
|
|
Cash and cash equivalents |
$ 36,853 |
$ 32,257 |
Short-term investments |
22,880 |
13,094 |
Prepaid expenses and other
current assets |
3,367 |
5,844 |
Total current
assets |
63,100 |
51,195 |
Acquired in process research and
development |
15,292 |
15,292 |
Goodwill |
5,811 |
5,811 |
Property and equipment, net |
897 |
981 |
Restricted cash |
1,147 |
852 |
Deferred charge |
10,081 |
12,417 |
Other assets |
3,816 |
— |
Total assets |
$ 100,144 |
$ 86,548 |
Liabilities and Stockholders'
Equity |
|
|
Current liabilities: |
|
|
Accounts payable |
$ 5,275 |
$ 8,618 |
Accrued expenses |
7,116 |
10,602 |
Income taxes payable |
1,609 |
2,281 |
Total current liabilities |
14,000 |
21,501 |
Long-term debt |
25,000 |
— |
Non-current income tax payable |
1,377 |
1,117 |
Contingent consideration |
20,889 |
19,836 |
Other liabilities |
299 |
222 |
Total liabilities |
61,565 |
42,676 |
Total stockholders' equity |
38,579 |
43,872 |
Total liabilities and stockholders'
equity |
$ 100,144 |
$ 86,548 |
|
|
|
|
DURATA THERAPEUTICS,
INC. AND SUBSIDIARIES |
(A Development Stage
Company) |
Consolidated Statements of
Operations |
(in thousands, except share and
per share data) |
|
|
|
|
|
|
|
|
|
|
|
Period from |
|
|
|
|
|
inception |
|
|
|
|
|
(November 4, |
|
Three month period
ended |
|
|
2009) to |
|
December
31, |
Year ended December
31, |
December 31, |
|
2013 |
2012 |
2013 |
2012 |
2013 |
Operating expenses: |
|
|
|
|
|
Research and development
expenses |
$ 7,118 |
$ 9,440 |
$ 37,317 |
$ 51,695 |
$ 124,161 |
General and administrative
expenses |
5,215 |
3,622 |
18,602 |
9,788 |
36,384 |
Acquisition related charges,
net |
214 |
280 |
1,053 |
1,097 |
9,597 |
|
|
|
|
|
|
Operating
loss |
12,547 |
13,342 |
56,972 |
62,580 |
170,142 |
|
|
|
|
|
|
Other (income) expense |
|
|
|
|
|
Interest expense |
816 |
-- |
2,226 |
-- |
2,226 |
Loss on early extinguishment of
debt |
2,228 |
-- |
2,228 |
-- |
2,228 |
Interest income |
(13) |
(23) |
(62) |
(41) |
(121) |
Other income |
(501) |
-- |
(501) |
-- |
(501) |
Total other
(income) expense |
2,530 |
(23) |
3,891 |
(41) |
3,832 |
|
|
|
|
|
|
Loss before income tax expense (benefit) |
15,077 |
13,319 |
60,863 |
62,539 |
173,974 |
|
|
|
|
|
|
Income tax expense (benefit) |
563 |
-- |
1,278 |
-- |
(4,533) |
|
|
|
|
|
|
Net loss |
$ (15,640) |
$ (13,319) |
$ (62,141) |
$ (62,539) |
$ (169,441) |
|
|
|
|
|
|
Net loss per common share – Basic and
Diluted |
$ (0.59) |
$ (0.73) |
$ (2.57) |
$ (7.48) |
|
Weighted average common shares – Basic and
Diluted |
26,623,724 |
18,359,667 |
24,224,590 |
8,364,432 |
|
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
Media Relations Contact
Geoff Curtis
DJE Science
(312) 233-1253
geoff.curtis@djescience.com
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