CAMBRIDGE, Mass., Oct. 29 /PRNewswire-FirstCall/ -- Idenix
Pharmaceuticals, Inc. (Nasdaq: IDIX), a biopharmaceutical company
engaged in the discovery and development of drugs for the treatment
of human viral diseases, today reported unaudited financial results
for the third quarter and nine months ended September 30, 2010. At September 30, 2010, Idenix's cash and cash
equivalents totaled $37.0
million.
Third Quarter 2010 Financial Results
For the third quarter ended September 30,
2010, Idenix reported total revenues of $3.8 million, compared to total revenues of
$3.1 million in the third quarter of
2009. The company reported a net loss of $12.9 million, or a loss of $0.18 per basic and diluted share, for the third
quarter ended September 30, 2010,
compared to a net loss of $ $11.7
million, or a loss of $0.18
per basic and diluted share for the third quarter ended
September 30, 2009.
For the nine months ended September 30,
2010, Idenix reported total revenues of $7.8 million, compared to total revenues of
$9.6 million for the nine months
ended September 30, 2009. The company
reported a net loss of $45.4 million,
or a loss of $0.65 per basic and
diluted share, for the nine months ended September 30, 2010, compared to a net loss of
$40.9 million, or a loss of
$0.68 per basic and diluted share,
for the nine months ended September 30,
2009.
2010 Financial Guidance
The company expects that its current cash and cash equivalents,
the anticipated royalty payments associated with product sales of
Tyzeka®/Sebivo® (telbivudine) and its ability and intent to manage
expenditures will be sufficient to satisfy our cash needs for at
least the next 12 months. This guidance assumes no additional
milestone payments, license fees, reimbursement for development
programs and no financing activities.
Regulatory Update
In September 2010, the U.S. Food
and Drug Administration (FDA) placed two of our HCV drug
candidates, IDX184 and IDX320, on clinical hold following a 14-day
drug-drug interaction study of a combination of IDX184 and IDX320
in healthy volunteers. Idenix is working with the FDA to determine
the next steps in the development of these drug candidates.
About Idenix
Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a
biopharmaceutical company engaged in the discovery and development
of drugs for the treatment of human viral diseases. Idenix's
current focus is on the treatment of patients with chronic
hepatitis C infection. For further information about Idenix, please
refer to www.idenix.com.
Forward-Looking Statements
This press release contains "forward-looking statements" for
purposes of the safe harbor provisions of The Private Securities
Litigation Reform Act of 1995, including but not limited to the
statements regarding the company's future business and financial
performance. For this purpose, any statements contained herein that
are not statements of historical fact may be deemed forward-looking
statements. Without limiting the foregoing, the words "expect,"
"plans," "anticipates," "will," "expects," "goal," "estimates,"
"projects," "would," "could," "targets," and similar expressions
are also intended to identify forward-looking statements, as are
expressed or implied statements with respect to the company's
clinical development programs or commercialization activities in
hepatitis C, or any potential pipeline candidates, including any
expressed or implied statements regarding the efficacy and safety
of our drug candidates, the likelihood and success of any future
clinical trials involving our drug candidates or successful
development of novel combinations of direct-acting antivirals for
the treatment of hepatitis C. Actual results may differ materially
from those indicated by such forward-looking statements as a result
of risks and uncertainties, including but not limited to the
following: there can be no guarantees that the company will advance
any clinical product candidate or other component of its potential
pipeline to the clinic, to the regulatory process or to
commercialization; management's expectations could be affected by
unexpected regulatory actions or delays, including the current
clinical hold on IDX184 and IDX320; uncertainties relating to, or
unsuccessful results of, clinical trials, including additional data
relating to the ongoing clinical trials evaluating its product
candidates; the company's ability to obtain additional funding
required to conduct its research, development and commercialization
activities; the company's dependence on its collaborations with
Novartis Pharma AG and GlaxoSmithKline; changes in the company's
business plan or objectives; the ability of the company to attract
and retain qualified personnel; competition in general; and the
company's ability to obtain, maintain and enforce patent and other
intellectual property protection for its product candidates and its
discoveries. Such forward-looking statements involve known and
unknown risks, uncertainties and other factors that may cause
actual results to be materially different from any future results,
performance or achievements expressed or implied by such
statements. These and other risks which may impact management's
expectations are described in greater detail under the heading
"Risk Factors" in each of the company's annual report on Form 10-K
for the year ended December 31, 2009
and quarterly report on form 10-Q for the quarter ended
June 30, 2010, as filed with the
Securities and Exchange Commission (SEC) and in any subsequent
periodic or current report that the company files with the SEC.
All forward-looking statements reflect the company's estimates
only as of the date of this release (unless another date is
indicated) and should not be relied upon as reflecting the
company's views, expectations or beliefs at any date subsequent to
the date of this release. While Idenix may elect to update these
forward-looking statements at some point in the future, it
specifically disclaims any obligation to do so, even if the
company's estimates change.
IDENIX
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(IN
THOUSANDS, EXCEPT PER SHARE DATA)
(UNAUDITED)
|
|
|
Three Months
Ended September 30,
|
Nine Months
Ended September 30,
|
|
|
2010
|
|
2009
|
|
2010
|
|
2009
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
Collaboration revenue – related party
|
$ 3,424
|
|
$ 2,840
|
|
$ 6,366
|
|
$ 8,937
|
|
|
Other
revenue
|
364
|
|
267
|
|
1,421
|
|
631
|
|
|
Total revenues
|
3,788
|
|
3,107
|
|
7,787
|
|
9,568
|
|
|
Operating expenses
(1):
|
|
|
|
|
|
|
|
|
|
Cost
of revenues
|
566
|
|
546
|
|
1,800
|
|
1,500
|
|
|
Research and development
|
11,637
|
|
9,349
|
|
35,548
|
|
31,599
|
|
|
General and
administrative
|
4,440
|
|
5,207
|
|
14,308
|
|
16,579
|
|
|
Restructuring charges
|
-
|
|
-
|
|
2,238
|
|
1,506
|
|
|
Total operating expenses
|
16,643
|
|
15,102
|
|
53,894
|
|
51,184
|
|
|
Loss from operations
|
(12,855)
|
|
(11,995)
|
|
(46,107)
|
|
(41,616)
|
|
|
Other income (expense), net
|
(76)
|
|
323
|
|
712
|
|
791
|
|
|
Loss before income taxes
|
(12,931)
|
|
(11,672)
|
|
(45,395)
|
|
(40,825)
|
|
|
Income tax benefit (expense)
|
1
|
|
5
|
|
(3)
|
|
(82)
|
|
|
Net loss
|
$(12,930)
|
|
$(11,667)
|
|
$(45,398)
|
|
$(40,907)
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per
share:
|
($0.18)
|
|
($0.18)
|
|
($0.65)
|
|
($0.68)
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in calculation of
basic and diluted net loss per share:
|
72,934
|
|
63,493
|
|
69,941
|
|
59,861
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Share-based compensation
expenses included in operating expenses amounted to
approximately:
|
|
|
|
|
|
|
|
|
|
Research and development
|
$
308
|
|
$
363
|
|
$
942
|
|
$ 1,210
|
|
|
General and
administrative
|
646
|
|
745
|
|
1,950
|
|
2,345
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
IDENIX
PHARMACEUTICALS, INC.
|
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|
(IN
THOUSANDS)
|
|
(UNAUDITED)
|
|
|
|
September
30,
|
December
31,
|
|
|
|
2010
|
2009
|
|
|
|
|
|
|
ASSETS
|
|
|
|
Cash and cash
equivalents
|
$ 37,020
|
$ 46,519
|
|
Receivables from related
party
|
1,069
|
1,049
|
|
Other current assets
|
3,725
|
4,012
|
|
|
Total current assets
|
41,814
|
51,580
|
|
Intangible asset, net
|
10,142
|
11,069
|
|
Property and equipment,
net
|
7,658
|
10,091
|
|
Marketable securities
|
-
|
1,584
|
|
Other assets
|
3,475
|
2,326
|
|
|
Total assets
|
$ 63,089
|
$ 76,650
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS'
DEFICIT
|
|
|
|
Accounts payable and accrued
expenses
|
$ 12,603
|
$ 10,720
|
|
Deferred revenue, related
party
|
3,115
|
6,155
|
|
Other current
liabilities
|
2,130
|
1,469
|
|
|
Total current
liabilities
|
17,848
|
18,344
|
|
Long-term obligations
|
36,381
|
32,983
|
|
Deferred revenue, related party,
net of current portion
|
30,113
|
30,776
|
|
|
Total liabilities
|
84,342
|
82,103
|
|
Stockholders' deficit
|
(21,253)
|
(5,453)
|
|
|
Total liabilities and
stockholders' deficit
|
$ 63,089
|
$ 76,650
|
|
|
|
|
|
Idenix Pharmaceuticals
Contacts:
|
|
Jonae Barnes (617) 224-4485
(investors)
|
|
Kelly Barry (617) 995-9033
(media)
|
|
|
SOURCE Idenix Pharmaceuticals, Inc.
Copyright . 29 PR Newswire