CAMBRIDGE, Mass., Nov. 2, 2011 /PRNewswire/ -- 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, 2011. At September 30, 2011, Idenix's cash and cash
equivalents totaled $64.7
million.
Third Quarter and Nine Month 2011 Financial Results
For the third quarter ended September 30,
2011, Idenix reported total revenues of $2.6 million, compared to total revenues of
$3.8 million in the third quarter of
2010. The Company reported a net loss of $11.7 million, or a loss of $0.12 per basic and diluted share, for the third
quarter ended September 30, 2011,
compared to 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.
For the nine months ended September 30,
2011, Idenix reported total revenues of $7.7 million, compared to total revenues of
$7.8 million in the nine months ended
September 30, 2010. The Company
reported a net loss of $33.9 million,
or a loss of $0.39 per basic and
diluted share, for the nine months ended September 30, 2011, compared to 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. The $11.5 million
reduction in net loss in 2011 was due primarily to $5.5 million of lower expenses related to
devoting fewer resources to our protease inhibitor and
non-nucleoside polymerase inhibitor programs during 2011,
$3.1 million lower salaries and
personnel related costs, $2.6 million
of lower costs related to the timing of clinical trials of IDX184
and $2.2 million of non-recurring
restructuring expenses in 2010. Offsetting these amounts was an
increase of $3.7 million in expenses
related to the preclinical development of our NS5A drug
candidates.
2011 Financial Guidance
The Company expects that its current cash, cash equivalents and the
anticipated royalty payments associated with product sales of
Tyzeka®/Sebivo® (telbivudine) will be sufficient to satisfy its
cash needs into at least the second quarter of 2012. This guidance
assumes no additional milestone payments, license fees,
reimbursement for development programs and no financing
activities.
Operational Highlights
IDX184 Program
The Company's lead program, IDX184, is a pan-genotypic oral
nucleotide polymerase inhibitor that has shown potent antiviral
activity in both preclinical and clinical studies. IDX184 is a
proprietary liver-targeted prodrug of 2'-methyl guanosine
monophosphate with a high barrier to resistance in
vitro.
In July 2011, the Company
initiated enrollment of 100 HCV-infected patients into a 12-week
Phase IIb clinical trial of IDX184 in combination with pegylated
interferon and ribavirin. The Company will report an interim
analysis from this study after the first 30 patients have completed
28 days of treatment. The Company initiated dosing of the first 20
patients, and is currently enrolling the remaining ten patients.
There have been no safety signals to date. Based on the current
rate of enrollment, the Company expects to complete one month
dosing of the first 30 patients in December
2011, and anticipates releasing interim one month safety and
antiviral activity data for the first 30 patients from the Phase
IIb trial early in the first quarter of 2012.
Discovery Programs
IDX719, the Company's lead NS5A inhibitor candidate, has shown
potent and broad genotypic activity. The Company expects to submit
regulatory filings by year end 2011 and begin the clinical program
in early 2012.
The Company's novel nucleotide program continues to make
significant progress and has generated many preclinical compounds.
Given the progress of the Company's nucleotide prodrugs, the
Company is reallocating discovery and development resources from
its protease inhibitor program to the nucleotide program. The
Company will continue to evaluate potential partnerships and
licensing agreements for its protease inhibitor drug candidates and
related intellectual property.
Upcoming Meetings/Conferences
American Association for the Study of Liver Diseases Meeting
(AASLD)
Idenix will present two posters at AASLD in San Francisco, California:
- McCarville, et al, "Patterns of NS5B mutations in a
3-day clinical trial of HCV non-nucleoside polymerase inhibitor
IDX375" will be presented in a poster session on November 5, 2011 starting at 2:00pm PT
- McCarville, et al, "In vivo resistance profile of IDX320
after 3 days of dosing in genotype 1 HCV-infected patients"
will be presented in a poster session on November 5, 2011 starting at 2:00pm PT
HEP DART Meeting
Idenix will have a presentation at HEP DART in Koloa, Hawaii:
- Mayers, D. and Standring, D., "Combination DAA Strategies to
Cure HCV" will be featured as an oral presentation on
December 4, 2011
Credit Suisse 2011 Healthcare Conference
Idenix management will present a corporate overview at the Credit
Suisse 2011 Healthcare Conference on November 9, 2011 at 4:30
p.m. MST at the Arizona Biltmore Hotel, Phoenix.
The live and archived webcast of the company presentation can be
accessed under "Calendar of Events" in the Idenix Investor Center
at www.idenix.com. Please log in approximately 5-10 minutes before
the event to ensure a timely connection. The archived replay will
be available on the Idenix website for two weeks following the
conference.
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.
CONFERENCE CALL AND WEBCAST INFORMATION
Idenix will hold a conference call today at 4:30 p.m. ET. To access the call, please dial
(877) 640-9809 (U.S./Canada) or
(914) 495-8528 (International) and enter passcode 22292830. A slide
presentation will accompany the conference call and can be accessed
on the Investor section of the Idenix website at www.idenix.com.
Please log on approximately 10 minutes prior to the start of the
call to ensure adequate time for any downloads that may be
necessary.
A replay of the conference call and webcast will be available
until November 16, 2011, by dialing
(855) 859-2056 (U.S./Canada) or
(404) 537-3406 (International) and enter the passcode 22292830.
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," "intends," "will," and similar expressions
are also intended to identify forward-looking statements, as are
expressed or implied statements with respect to the Company's
potential pipeline candidates, including any expressed or implied
statements regarding the efficacy and safety of IDX184 or any other
drug candidate; the successful development of novel combinations of
direct-acting antivirals for the treatment of hepatitis C; the
likelihood and success of any future clinical trials involving our
drug candidates; and expectations with respect to additional
milestone payments, future royalty payments, funding of operations
and future cash balances. 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; 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/ViiV Healthcare; 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 the Company's annual report on Form 10-K
for the year ended December 31, 2010
and the quarterly report on Form 10-Q for the quarter ended
June 30, 2011, each 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,
|
|
|
2011
|
|
2010
|
|
2011
|
|
2010
|
|
Revenues:
|
|
|
|
|
|
|
|
|
Collaboration revenue – related party
|
$ 1,982
|
|
$ 3,424
|
|
$ 5,715
|
|
$ 6,366
|
|
Other
revenue
|
656
|
|
364
|
|
1,967
|
|
1,421
|
|
Total
revenues
|
2,638
|
|
3,788
|
|
7,682
|
|
7,787
|
|
Operating expenses
(1):
|
|
|
|
|
|
|
|
|
Cost
of revenues
|
595
|
|
566
|
|
1,731
|
|
1,800
|
|
Research and development
|
10,190
|
|
11,637
|
|
28,530
|
|
35,548
|
|
General and
administrative
|
3,900
|
|
4,440
|
|
12,293
|
|
14,308
|
|
Restructuring charges
|
-----
|
|
-----
|
|
-----
|
|
2,238
|
|
Total
operating expenses
|
14,685
|
|
16,643
|
|
42,554
|
|
53,894
|
|
Loss from operations
|
(12,047)
|
|
(12,855)
|
|
(34,872)
|
|
(46,107)
|
|
Other income (expense), net
|
338
|
|
(76)
|
|
1,019
|
|
712
|
|
Loss before income taxes
|
(11,709)
|
|
(12,931)
|
|
(33,853)
|
|
(45,395)
|
|
Income tax benefit (expense)
|
-----
|
|
1
|
|
(1)
|
|
(3)
|
|
Net loss
|
$(11,709)
|
|
$(12,930)
|
|
$(33,854)
|
|
$(45,398)
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per
share:
|
($0.12)
|
|
($0.18)
|
|
($0.39)
|
|
($0.65)
|
|
Shares used in calculation of
basic and diluted net loss per share:
|
96,133
|
|
72,934
|
|
87,414
|
|
69,941
|
|
|
|
|
(1) Share-based compensation
expenses included in operating
expenses amounted to
approximately:
|
|
|
Research and development
|
$
269
|
|
$
308
|
|
$
820
|
|
$ 942
|
|
General and
administrative
|
345
|
|
646
|
|
1,023
|
|
1,950
|
|
|
|
|
|
|
|
|
|
|
|
IDENIX
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(IN
THOUSANDS)
(UNAUDITED)
|
|
|
September
30,
2011
|
December
31,
2010
|
|
ASSETS
|
|
|
|
|
|
|
|
Receivables from related
party
|
$ 64,693
|
$ 46,115
|
|
Cash and cash
equivalents
|
1,161
|
840
|
|
Other current assets
|
3,845
|
2,535
|
|
|
Total current assets
|
69,699
|
49,490
|
|
Intangible asset, net
|
8,992
|
9,843
|
|
Property and equipment,
net
|
5,647
|
7,179
|
|
Other assets
|
4,451
|
3,372
|
|
|
Total assets
|
$
88,789
|
$
69,884
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS'
DEFICIT
|
|
|
|
|
|
|
|
Accounts payable and accrued
expenses
|
$ 8,952
|
$ 14,030
|
|
Deferred revenue, related
party
|
3,040
|
3,036
|
|
Other current
liabilities
|
3,104
|
2,928
|
|
|
Total current
liabilities
|
15,096
|
19,994
|
|
Other long-term
obligations
|
49,659
|
52,398
|
|
Deferred revenue, related party,
net of current portion
|
26,343
|
28,588
|
|
|
Total liabilities
|
91,098
|
100,980
|
|
Stockholders' deficit
|
(2,309)
|
(31,096)
|
|
|
Total liabilities and
stockholders' deficit
|
$
88,789
|
$
69,884
|
|
|
|
|
|
|
|
|
|
|
|
Idenix Pharmaceuticals Contacts:
Kelly Barry (617) 995-9033
(media)
Eric Hoffman (617) 224-4485
(investors)
SOURCE Idenix Pharmaceuticals, Inc.