Idenix Pharmaceuticals Reports Second Quarter and Six Month 2013 Financial Results
August 07 2013 - 7:00AM
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 second quarter ended June 30, 2013.
HCV Pipeline and Business Review
Samatasvir (IDX719), NS5A Inhibitor Program
- In May 2013, Idenix initiated the phase II HELIX-1 12-week
clinical trial evaluating an all-oral, direct-acting antiviral
(DAA) HCV combination regimen of samatasvir (IDX719), Idenix's
once-daily pan-genotypic NS5A inhibitor, and simeprevir (TMC435), a
once-daily protease inhibitor jointly developed by Janssen R&D
Ireland and Medivir AB. Treatment-naïve, non-cirrhotic, genotype 1b
or 4 HCV-infected patients are enrolled in one of three treatment
groups receiving 50, 100, or 150 mg samatasvir once-daily for 12
weeks in combination with simeprevir plus ribavirin.
- The first cohort of patients (n=29) has completed enrollment.
The Data Safety Monitoring Board has reviewed all data relating to
this cohort up to 28 days of treatment and recommended that the
study continue enrollment, which is now underway.
- The treatment regimen has been well tolerated and there have
been no treatment-related serious adverse events in the clinical
trial to date.
- Rates of sustained virologic response measured four weeks after
the end of treatment (SVR4) will be available for the first cohort
of patients in the fourth quarter of 2013.
- A second trial (HELIX-2) of samatasvir, simeprevir and
TMC647055, a once-daily non-nucleoside polymerase inhibitor boosted
with low-dose ritonavir being developed by Janssen, is expected to
begin enrolling genotype 1 or 4 treatment-naïve HCV-infected
patients in the third quarter of 2013.
Nucleotide Inhibitor Program
- In June 2013, Idenix announced a request from the United States
Food and Drug Administration (FDA) for additional preclinical
safety information for IDX20963, Idenix's lead uridine nucleotide
prodrug candidate. Pending potential resolution of this request,
the initiation of clinical testing of IDX20963 in the U.S. is on
hold. Idenix has supplemental preclinical work ongoing and is
compiling data to respond to the FDA's communication. The Company
is simultaneously pursuing a clinical development strategy for
IDX20963 outside the U.S.
- Additionally, Idenix plans to file a regulatory submission to
initiate clinical trials for a second uridine nucleotide prodrug
inhibitor in the second half of 2013.
"In the second quarter, we saw significant progress of our lead
HCV development program, samatasvir, and continue to be on track to
report data from the first patient cohort in the fourth quarter of
this year," said Ron Renaud, Idenix's President and Chief Executive
Officer. "We remain committed to our HCV nucleotide franchise, and
we are actively pursuing additional paths forward with the ultimate
goal remaining the evaluation of an all-oral internally developed
pan-genotypic combination regimen including samatasvir and a
nucleotide inhibitor."
Second Quarter and Six Months Ended 2013 Financial
Results
For the second quarter ended June 30, 2013, Idenix reported
total revenues of $0.1 million, compared to total revenues of $1.4
million in the second quarter of 2012. The Company reported a net
loss of $28.9 million, or $0.22 per basic and diluted share, for
the second quarter ended June 30, 2013, compared to a net loss of
$25.4 million, or $0.23 per basic and diluted share for the second
quarter ended June 30, 2012.
For the six months ended June 30, 2013, Idenix reported total
revenues of $1.0 million, compared to total revenues of $37.1
million for the six months ended June 30, 2012. The Company
reported a net loss of $59.7 million, or $0.45 per basic and
diluted share, for the six months ended June 30, 2013, compared to
a net loss of $13.9 million, or $0.13 per basic and diluted share
for the six months ended June 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 $4.7
million in research and development expenses and $6.1 million in
general and administrative expenses mainly due to patent
interference and litigation costs.
2013 Financial Guidance
At June 30, 2013, Idenix's cash and cash equivalents totaled
$177.6 million. The Company continues to expect that its current
cash and cash equivalents will be sufficient to sustain its
operations into at least the second half of 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 8:00 a.m. ET
today. To access the call, please dial (877) 640-9809 (U.S./Canada)
or (914) 495-8528 (International) and enter passcode 20505896. 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 IDX719 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 IDX719,
IDX20963 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 March 31, 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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|
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CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME
(LOSS) |
|
|
|
|
|
(IN THOUSANDS, EXCEPT
PER SHARE DATA) |
|
|
|
|
|
(UNAUDITED) |
|
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|
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|
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Three Months Ended June
30, |
Six Months Ended |
|
June 30, |
June 30, |
|
2013 |
2012 |
2013 |
2012 |
Revenues: |
|
|
|
|
Collaboration revenue – related
party |
$ 112 |
$ 1,438 |
$ 964 |
$ 1,015 |
Other revenue |
----- |
----- |
----- |
36,068 |
Total revenues |
112 |
1,438 |
964 |
37,083 |
Operating expenses (1): |
|
|
|
|
Cost of revenues |
368 |
623 |
700 |
1,793 |
Research and development |
19,779 |
20,542 |
43,787 |
39,135 |
General and administrative |
9,141 |
5,861 |
16,676 |
10,635 |
Total operating expenses |
29,288 |
27,026 |
61,163 |
51,563 |
Loss from operations |
(29,176) |
(25,588) |
(60,199) |
(14,480) |
Other income, net |
257 |
193 |
528 |
536 |
Loss before income taxes |
(28,919) |
(25,395) |
(59,671) |
(13,944) |
Income tax expense |
----- |
----- |
(1) |
(1) |
Net loss |
$(28,919) |
$(25,395) |
$(59,672) |
$(13,945) |
|
|
|
|
|
Basic and diluted net loss per share: |
($0.22) |
($0.23) |
($0.45) |
($0.13) |
|
|
|
|
|
Shares used in calculation of basic and
diluted net loss per share: |
133,960 |
108,372 |
133,959 |
108,061 |
|
|
|
|
|
Comprehensive loss: |
|
|
|
|
Net loss |
$ (28,919) |
$ (25,395) |
$ (59,672) |
$ (13,945) |
Changes in other comprehensive
income: |
|
|
|
|
Foreign currency translation
adjustment |
151 |
(460) |
(198) |
(252) |
Comprehensive loss |
$ (28,768) |
$ (25,855) |
$ (59,870) |
$ (14,197) |
(1) Share-based
compensation expenses included in operating expenses amounted to
approximately: |
|
Research and development |
$526 |
$484 |
$995 |
$783 |
General and administrative |
861 |
703 |
1,640 |
1,135 |
|
IDENIX PHARMACEUTICALS,
INC. |
|
|
|
CONDENSED CONSOLIDATED
BALANCE SHEETS |
|
|
|
(IN
THOUSANDS) |
|
|
|
(UNAUDITED) |
|
|
|
|
|
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June 30, |
December 31, |
|
2013 |
2012 |
|
|
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ASSETS |
|
|
Cash and cash equivalents |
$ 177,600 |
$ 230,826 |
Receivables from related party |
1,033 |
1,195 |
Other current assets |
6,332 |
5,771 |
Total current assets |
184,965 |
237,792 |
Property and equipment, net |
3,119 |
3,274 |
Receivables from related party, net of
current portion |
5,622 |
6,210 |
Other assets |
4,248 |
3,589 |
Total assets |
$ 197,954 |
$ 250,865 |
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
Accounts payable and accrued expenses |
$ 20,133 |
$ 15,064 |
Deferred revenue, related party |
714 |
714 |
Other current liabilities |
420 |
154 |
Total current liabilities |
21,267 |
15,932 |
Other long-term obligations |
11,723 |
11,785 |
Deferred revenue, related party, net of
current portion |
3,631 |
3,988 |
Total liabilities |
36,621 |
31,705 |
Stockholders' equity |
161,333 |
219,160 |
Total liabilities and
stockholders' equity |
$ 197,954 |
$ 250,865 |
CONTACT: Idenix Pharmaceuticals Contact:
Teri Dahlman (617) 995-9807
(MM) (NASDAQ:IDIX)
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