-- Enrollment initiated for a phase I/II clinical trial for
IDX21437, a next-generation uridine nucleotide prodrug inhibitor
for the treatment of hepatitis C virus infection (HCV) --
Initiation planned for HELIX-2 combination study in collaboration
with Janssen Pharmaceuticals, Inc. including pan-genotypic HCV NS5A
inhibitor, samatasvir -- Idenix to host conference call / webcast
at 4:30 p.m. ET today
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 ended September 30,
2013.
HCV Pipeline Review
Nucleotide Inhibitor Program
- IDX21437, a next-generation uridine nucleotide prodrug
inhibitor, has received approval to enter clinical trials in Canada
and Belgium. Idenix has initiated enrollment for the healthy
volunteer portion of a phase I/II clinical trial. Extensive
preclinical testing for IDX21437 demonstrated favorable antiviral
activity across genotypes 1-6 and a safety profile which supported
advancement into clinical trials.
- Idenix is conducting additional preclinical work as requested
by the United States Food and Drug Administration for IDX20963, a
uridine nucleotide prodrug candidate.
Samatasvir (IDX719), NS5A Inhibitor Program
- All patients (n=63) have completed enrollment in Part A of the
phase II 12-week HELIX-1 clinical trial evaluating an all-oral,
direct-acting antiviral (DAA) HCV combination regimen of
samatasvir, Idenix's once-daily pan-genotypic NS5A inhibitor, and
simeprevir, a once-daily NS3/4A protease inhibitor jointly
developed by Janssen R&D Ireland and Medivir AB, and ribavirin
in treatment-naive, non-cirrhotic, genotype 1b or 4 HCV-infected
patients. SVR4 data for patients in Part A of the study are
anticipated to be available in the fourth quarter of 2013. Part B
of the ongoing HELIX-1 clinical trial includes exploratory cohorts
which have been added to evaluate the safety and antiviral activity
of a 25 mg dose of samatasvir in genotype 1b-infected patients and
of a 100 mg dose of samatasvir in genotype 6-infected
patients.
- Idenix is planning to initiate a second 12-week phase II
clinical trial in collaboration with Janssen Pharmaceuticals, Inc.,
HELIX-2, which will evaluate the 3-DAA combination of samatasvir,
simeprevir and TMC647055, a once-daily NS5B non-nucleoside
polymerase inhibitor boosted with low-dose ritonavir being
developed by Janssen R&D Ireland, with and without ribavirin in
genotype 1-infected patients who are either treatment-naive or have
previously relapsed after treatment with pegylated interferon and
ribavirin.
"A key objective for our development teams has been to commence
a clinical trial for our nucleotide prodrug program this year,"
said Ron Renaud, Idenix's President and Chief Executive Officer.
"Based on the differentiated profile we've seen in our preclinical
research, we believe IDX21437 has strong potential to be a key
component of a fixed-dose all-oral pan-genotypic regimen,
specifically in combination therapy with our NS5A inhibitor."
Mr. Renaud continued, "We are also pleased with the progress of
the phase II program for samatasvir. The ongoing HELIX-1 study is
building the safety and antiviral efficacy profile for samatasvir
as part of a 12-week all-oral treatment regimen and supporting
future combination studies, including the 3-DAA HELIX-2 study, as
well as the evaluation of a pan-genotypic combination with IDX21437
in 2014."
Third Quarter and Nine Months Ended 2013 Financial
Results
For the third quarter ended September 30, 2013, Idenix reported
total revenues of less than $0.1 million, compared to total
revenues of $32.3 million in the third quarter of 2012. The Company
reported a net loss of $34.0 million, or $0.25 per basic and
diluted share, for the third quarter ended September 30, 2013,
compared to a net income of $4.3 million, or $0.03 per basic and
diluted share for the third quarter ended September 30, 2012.
For the nine months ended September 30, 2013, Idenix reported
total revenues of $1.0 million, compared to total revenues of $69.3
million for the nine months ended September 30, 2012. The Company
reported a net loss of $93.6 million, or $0.70 per basic and
diluted share, for the nine months ended September 30, 2013,
compared to a net loss of $9.7 million, or $0.09 per basic and
diluted share for the nine months ended September 30, 2012. The
change in net loss was mainly due to additional revenue as a result
of the recognition of $36.1 million of deferred revenue in the
first quarter of 2012 related to the termination of the license
agreement with ViiV Healthcare Company. Additionally, there were
increases of $12.9 million in research and development expenses
mainly due to the advancement of our drug candidates and $8.5
million in general and administrative expenses mainly due to patent
interference and litigation costs.
2013 Financial Guidance
At September 30, 2013, Idenix's cash and cash equivalents
totaled $148.8 million. The Company continues to expect that its
current cash and cash equivalents will be sufficient to sustain its
operations through December 2014. This guidance assumes no
milestone payments or license fees, no reimbursement for
development programs and no financing activities.
CONFERENCE CALL AND WEBCAST INFORMATION
Idenix management will host a conference call at 4:30 p.m. ET
today. To access the call, please dial (877) 640-9809
(U.S./Canada) or (914) 495-8528 (International) and enter passcode
90503423. A live webcast will be available through the
Investor section of the Idenix website at www.idenix.com under
"Events & Presentations". The archived webcast will be
available for two weeks following the call on the Idenix
website.
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.
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 samatasvir 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
samatasvir, IDX20963, IDX21437 or our other drug candidates; and
expectations with respect to 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 expectations regarding the benefits of
the restructuring of 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, 2012 and the quarterly report on
Form 10-Q for the quarter ended June 30, 2013, 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. |
|
|
|
|
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CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME
(LOSS) |
|
|
|
|
|
(IN THOUSANDS, EXCEPT
PER SHARE DATA) |
|
|
|
|
|
(UNAUDITED) |
|
|
|
|
|
|
Three Months Ended
September 30, |
Nine Months Ended
September 30, |
|
2013 |
2012 |
2013 |
2012 |
Revenues: |
|
|
|
|
Collaboration revenue – related
party |
$19 |
$32,253 |
$983 |
$33,268 |
Other revenue |
-- |
-- |
-- |
36,068 |
Total revenues |
19 |
32,253 |
983 |
69,336 |
Operating expenses (1): |
|
|
|
|
Cost of revenues |
15 |
509 |
715 |
2,302 |
Research and development |
21,673 |
13,469 |
65,460 |
52,604 |
General and administrative |
8,630 |
6,164 |
25,306 |
16,798 |
Restructuring charges |
3,900 |
-- |
3,900 |
-- |
Intangible asset impairment |
-- |
8,045 |
-- |
8,045 |
Total operating expenses |
34,218 |
28,187 |
95,381 |
79,749 |
Income (loss) from operations |
(34,199) |
4,066 |
(94,398) |
(10,413) |
Other income, net |
244 |
205 |
772 |
740 |
Income (loss) before income taxes |
(33,955) |
4,271 |
(93,626) |
(9,673) |
Income tax expense |
-- |
-- |
(1) |
(1) |
Net income (loss) |
$(33,955) |
$4,271 |
$(93,627) |
$(9,674) |
Earnings (loss) per common share: |
|
|
|
|
Basic |
$(0.25) |
$0.03 |
$(0.70) |
$(0.09) |
Diluted |
$(0.25) |
$0.03 |
$(0.70) |
$(0.09) |
Weighted average number of common
shares outstanding: |
|
|
|
Basic |
133,969 |
124,770 |
133,962 |
113,671 |
Diluted |
133,969 |
126,847 |
133,962 |
113,671 |
Comprehensive income (loss): |
|
|
|
|
Net income (loss) |
$(33,955) |
$4,271 |
$(93,627) |
$(9,674) |
Changes in other comprehensive
income: |
|
|
|
|
Foreign currency translation
adjustment |
472 |
163 |
274 |
(89) |
Comprehensive income (loss) |
$(33,483) |
$4,434 |
$(93,353) |
$(9,763) |
(1) Share-based compensation
expenses included in operating expenses amounted to
approximately: |
Research and development |
$387 |
$495 |
$1,382 |
$1,277 |
General and administrative |
835 |
741 |
2,475 |
1,877 |
|
IDENIX PHARMACEUTICALS,
INC. |
|
|
|
CONDENSED CONSOLIDATED
BALANCE SHEETS |
|
|
|
(IN
THOUSANDS) |
|
|
|
(UNAUDITED) |
|
|
|
|
September 30, |
December 31, |
|
2013 |
2012 |
|
|
|
ASSETS |
Cash and cash equivalents |
$148,832 |
$230,826 |
Receivables from related party |
1,657 |
1,195 |
Other current assets |
5,878 |
5,771 |
Total current assets |
156,367 |
237,792 |
Property and equipment, net |
2,920 |
3,274 |
Receivables from related party, net of
current portion |
5,354 |
6,210 |
Other assets |
3,593 |
3,589 |
Total assets |
$168,234 |
$250,865 |
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY |
Accounts payable and accrued expenses |
$19,612 |
$15,064 |
Deferred revenue, related party |
714 |
714 |
Other current liabilities |
698 |
154 |
Total current liabilities |
21,024 |
15,932 |
Other long-term obligations |
11,460 |
11,785 |
Deferred revenue, related party, net of
current portion |
3,452 |
3,988 |
Total liabilities |
35,936 |
31,705 |
Stockholders' equity |
132,298 |
219,160 |
Total liabilities and stockholders'
equity |
$168,234 |
$250,865 |
CONTACT: Idenix Pharmaceuticals:
Teri Dahlman (617) 995-9807
(MM) (NASDAQ:IDIX)
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