CAMBRIDGE, Mass., Feb. 23, 2012 /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 fourth quarter and year ended December 31, 2011 as well as the advancement of
its hepatitis C virus (HCV) development pipeline.
Operational Highlights
IDX184 Program
The Company's lead program, IDX184, is a pan-genotypic oral
nucleotide polymerase inhibitor for the treatment of HCV. In
July 2011, Idenix initiated
enrollment of treatment-naive HCV-infected patients into a 12-week
phase IIb clinical trial of IDX184 in combination with pegylated
interferon and ribavirin. In January
2012, the Company reported an interim analysis from this
study of the first 31 patients who completed 28 days of treatment
demonstrating favorable safety and antiviral activity. At 12 weeks,
the Complete Early Virologic Response (cEVR < 25 IU/mL) was 93%
for the 100 mg IDX184 arm (n=15) and 81% for the 50 mg IDX184 arm
(n=16) of the study (intent-to-treat analysis). The side effect
profile of the combined therapy has remained consistent with the
known safety profile for pegylated interferon and ribavirin.
In February 2012, the U.S. Food
and Drug Administration removed the partial clinical hold on IDX184
after review of the interim phase IIb data and the independent Data
Safety Monitoring Board's recommendation to continue the study. The
Company has now begun enrollment of an additional 30 patients under
expanded enrollment criteria in the ongoing phase IIb clinical
trial. Additionally, the Company anticipates implementing a broad
phase IIb program with IDX184, focusing on the evaluation of
interferon-free direct-acting antiviral (DAA) combination regimens,
in the coming months.
IDX719 Program
In January 2012, the Company
initiated a phase I clinical study of IDX719, its NS5A inhibitor
candidate. The first part of the study is evaluating the safety,
pharmacokinetics and food effect of IDX719 in 48 healthy volunteers
at single doses ranging from 5 to 100 mg. Dosing up to 50 mg has
been completed in healthy volunteers and to date IDX719 has been
well tolerated. A cohort of eight HCV genotype 1-infected patients
received single doses of IDX719 of either 1, 5, 10 or 25 mg (2
patients per dose). Mean maximal viral load reductions were 1.9
log(10), 2.6 log(10), 3.3 log(10) and 3.7 log(10), respectively. A
3-day proof-of-concept segment of the study in treatment-naive
genotype 1 HCV-infected patients is expected to begin in the second
quarter of 2012 with additional cohorts of genotype 2, 3, or 4
HCV-infected patients to be added during the study.
Nucleotide Discovery Program
In January 2012, Idenix selected
two nucleotide inhibitors, IDX19368 and IDX19370, as potential
clinical candidates from its novel nucleotide prodrug discovery
program. IDX19368 has demonstrated strong potency in preclinical
studies and as a result the Company has chosen IDX19368 as its lead
candidate and expects to submit an investigational new drug
application (IND) for IDX19368 in mid-2012. The Company continues
to identify new promising compounds and evaluate multiple
candidates for further development from this discovery program.
"Our focus for 2012 will be to build on the progress we made
last year through the continued advancement of our pipeline of
novel HCV drug candidates," said Ron
Renaud, Idenix's President and Chief Executive Officer. "Now
that the partial clinical hold has been removed for IDX184, we will
be able to explore the full potential of this promising nucleotide
polymerase inhibitor in combination with other DAAs in a broad
phase IIb program. The early results are promising for IDX719, our
NS5A inhibitor, in HCV patients and we look forward to completing
the phase I clinical trial, as well as initiating a phase I study
for our next-generation nucleotide inhibitor, IDX19368. We believe
that the potent and pan-genotypic profiles of our drug candidates
support their potential role in future HCV combination
regimens."
Fourth Quarter and Year End 2011 Financial Results
For the fourth quarter ended December 31,
2011, Idenix reported total revenues of ($0.7) million, compared to total revenues of
$2.4 million in the fourth quarter of
2010. In the fourth quarter of 2011, the Company recorded a charge
against revenue related to the impact of the stock subscription
rights of Novartis Pharma AG (Novartis), which is described in more
detail below. The Company reported a net loss of $18.1 million, or a loss of $0.18 per basic and diluted share, for the fourth
quarter ended December 31, 2011,
compared to a net loss of $16.2
million, or a loss of $0.22
per basic and diluted share for the fourth quarter ended
December 31, 2010.
Under the stock purchase agreement that Idenix entered into with
Novartis in 2003, Novartis has the right to maintain its percentage
ownership in Idenix by purchasing shares of Idenix's common stock
when stock options are exercised under certain stock plans. As of
December 31, 2011, the fair market
value of Idenix's common stock that would be issuable to Novartis
under this stock subscription right, less the exercise price that
would be paid by Novartis impacted the consolidated statements of
operations as a reduction of the revenue associated with the
Novartis collaboration. For the fourth quarter ended December 31, 2011, the Company recorded
$2.0 million of revenue related to
the Novartis collaboration and a charge against revenue of
$3.4 million due to this stock
subscription right resulting in net contra-revenue related to
Novartis of $1.4 million as shown in
the consolidated statements of operations.
For the year ended December 31,
2011, Idenix reported total revenues of $7.0 million, compared to total revenues of
$10.2 million in the year ended
December 31, 2010. The Company
reported a net loss of $52.0 million,
or a loss of $0.57 per basic and
diluted share, for the year ended December
31, 2011, compared to a net loss of $61.6 million, or a loss of $0.87 per basic and diluted share for the year
ended December 31, 2010. The
$9.6 million reduction in net loss in
2011 was due primarily to $7.2
million of non-recurring severance and restructuring
expenses in 2010.
2012 Financial Guidance
At December 31, 2011, Idenix's
cash and cash equivalents totaled $118.3
million. 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 sustain its operations through at least the next twelve months
from December 31, 2011. This guidance
assumes no milestone payments, license fees, reimbursement for
development programs and no financing activities.
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 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 48802750. 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 March 8, 2012, by dialing (855)
859-2056 (U.S./Canada) or (404)
537-3406 (International) and enter the passcode 48802750.
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, IDX719,
IDX368 or any other drug candidate; the successful development of
novel combinations of direct-acting antivirals for the treatment of
HCV; the likelihood and success of any future clinical trials
involving our drug candidates; and expectations with respect to
future milestone or 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 collaboration with
Novartis; 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 September 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
December 31,
|
Years
Ended
December 31,
|
|
|
2011
|
|
2010
|
|
2011
|
|
2010
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
Collaboration revenue – related party
|
$ (1,387)
|
|
$ (135)
|
|
$ 4,328
|
|
$ 6,231
|
|
|
Other
revenue
|
655
|
|
2,570
|
|
2,623
|
|
3,991
|
|
|
Total
revenues
|
(732)
|
|
2,435
|
|
6,951
|
|
10,222
|
|
|
Operating expenses
(1):
|
|
|
|
|
|
|
|
|
|
Cost
of revenues
|
593
|
|
965
|
|
2,324
|
|
2,765
|
|
|
Research and development
|
12,811
|
|
8,958
|
|
41,341
|
|
44,506
|
|
|
General and
administrative
|
4,399
|
|
9,132
|
|
16,694
|
|
23,439
|
|
|
Restructuring charges
|
-----
|
|
-----
|
|
-----
|
|
2,238
|
|
|
Total
operating expenses
|
17,803
|
|
19,055
|
|
60,359
|
|
72,948
|
|
|
Loss from operations
|
(18,535)
|
|
(16,620)
|
|
(53,408)
|
|
(62,726)
|
|
|
Other income, net
|
348
|
|
419
|
|
1,368
|
|
1,131
|
|
|
Loss before income taxes
|
(18,187)
|
|
(16,201)
|
|
(52,040)
|
|
(61,595)
|
|
|
Income tax benefit
|
62
|
|
44
|
|
61
|
|
40
|
|
|
Net loss
|
$(18,125)
|
|
$(16,157)
|
|
$(51,979)
|
|
$(61,555)
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per
share
|
($0.18)
|
|
($0.22)
|
|
($0.57)
|
|
($0.87)
|
|
|
Shares used in calculation of
basic and diluted net loss per share
|
100,973
|
|
73,011
|
|
90,831
|
|
70,715
|
|
|
(1) Share-based compensation
expenses included in operating expenses amounted to
approximately:
|
|
|
Research and development
|
$
246
|
|
$
272
|
|
$ 1,066
|
|
$ 1,214
|
|
|
General and
administrative
|
335
|
|
3,253
|
|
1,357
|
|
5,203
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
IDENIX
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(IN
THOUSANDS)
(UNAUDITED)
|
|
|
December
31,
2011
|
December
31,
2010
|
|
ASSETS
|
|
|
|
Cash and cash
equivalents
|
$ 118,271
|
$ 46,115
|
|
Receivables from related
party
|
1,157
|
840
|
|
Other current assets
|
4,410
|
2,535
|
|
Total current assets
|
123,838
|
49,490
|
|
Intangible asset, net
|
8,708
|
9,843
|
|
Property and equipment,
net
|
4,696
|
7,179
|
|
Other assets
|
3,802
|
3,372
|
|
Total assets
|
$
141,044
|
$
69,884
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY (DEFICIT)
|
|
|
|
Accounts payable and accrued
expenses
|
$ 11,299
|
$ 14,030
|
|
Deferred revenue, related
party
|
2,897
|
3,036
|
|
Other current
liabilities
|
36,329
|
2,928
|
|
Total current liabilities
|
50,525
|
19,994
|
|
Other long-term
obligations
|
14,912
|
52,398
|
|
Deferred revenue, related party,
net of current portion
|
24,382
|
28,588
|
|
Total liabilities
|
89,819
|
100,980
|
|
Stockholders' equity
(deficit)
|
51,225
|
(31,096)
|
|
Total liabilities and stockholders' equity
(deficit)
|
$
141,044
|
$
69,884
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Idenix Pharmaceuticals Contacts:
Kelly Barry (617) 995-9033
(media)
Teri Dahlman (617) 995-9807
(investors)
SOURCE Idenix Pharmaceuticals, Inc.