Idenix Pharmaceuticals Reports First Quarter 2014 Financial Results and HCV Pipeline Review
02 May 2014 - 6:05AM
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 first quarter ended March 31, 2014.
HCV Pipeline Review
- In April 2014, Idenix reported positive seven-day
proof-of-concept data from a phase I/II clinical trial for
IDX21437, the Company's lead uridine-based nucleotide prodrug
candidate. The trial demonstrated that IDX21437 was well tolerated
and exhibited potent pan-genotypic activity with mean maximal viral
load reductions of 4.2 - 4.3 log10 IU/mL for treatment-naïve
genotype 1, 2 and 3 HCV-infected patients in the highest dose group
(300 mg) for seven days. Based on these findings, the 300 mg dose
of IDX21437 has been chosen for an anticipated phase II combination
study of IDX21437 with samatasvir, Idenix's pan-genotypic NS5A
inhibitor. This phase II study is expected to initiate
mid-2014.
- Further, under a collaboration with Janssen Pharmaceuticals,
Inc., Idenix is evaluating samatasvir, simeprevir and TMC647055/r
in a phase II clinical program. HELIX-1 recently reported safety
and sustained virologic response rate (SVR4) findings at a medical
meeting, and HELIX-2 is expected to report SVR4 data in the second
half of 2014. In this phase II program, samatasvir-containing
regimens have been administered to more than 140 patients for
12-week treatment durations and have been safe and well tolerated
to date.
- Additionally, in April 2014, Idenix initiated enrollment for
the healthy volunteer portion of a phase I clinical trial of
IDX21459, a follow-on, uridine-based nucleotide prodrug candidate,
in Europe. IDX21459 has shown a favorable preclinical profile
including potent, pan-genotypic activity and favorable safety with
respect to cardiac, mitochondrial and genotoxicity
assessments.
"Idenix continues to make strong progress in advancing our
multiple clinical trials with a key goal of initiating a
combination study of IDX21437 with samatasvir for an all-oral
pan-genotypic regimen for HCV," said Ron Renaud, Idenix's President
and Chief Executive Officer. "The nucleotide prodrug/NS5A inhibitor
combination could play a major role in HCV treatment due to a
number of factors, including the scarcity of this combination, the
potential to deliver the convenience of once-daily dosing with one
pill, and the potential to be safe and potent with a high barrier
to resistance and limited drug-drug interaction concerns.
Importantly, we believe our combination has the potential to
provide an additional treatment option for patients, physicians and
payers in the evolving HCV landscape."
Registered Direct Offering
In January 2014, the Company issued 16.4 million shares of its
common stock to Baupost Group, L.L.C. through a registered direct
offering under a shelf registration and received $106.6 million in
net proceeds.
First Quarter 2014 Financial Results
For the first quarter ended March 31, 2014, Idenix reported
total revenues of $(3.0) million, compared to total revenues of
$0.9 million in the first quarter of 2013. The Company reported a
net loss of $34.1 million, or $0.24 per basic and diluted share,
for the first quarter ended March 31, 2014, compared to a net loss
of $30.8 million, or $0.23 per basic and diluted share for the
first quarter ended March 31, 2013. In the first quarter of 2014,
the Company recorded a charge against revenue related to the impact
of the stock subscription rights of Novartis Pharma AG, which is
described in more detail in the Company's quarterly report on Form
10-Q for the quarter ended March 31, 2014.
2014 Financial Guidance
At March 31, 2014, Idenix's cash and cash equivalents totaled
$205.0 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 2015. This guidance
assumes no milestone payments or license fees, no reimbursement for
development programs and no financing activities.
ABOUT IDENIX
Idenix Pharmaceuticals, Inc. is a biopharmaceutical company
engaged in the discovery and development of drugs for the treatment
of human viral diseases. Idenix is headquartered in Cambridge,
Massachusetts (USA). Its clinical development operations and drug
discovery operations are conducted in Cambridge and in the
Company's European laboratories in Montpellier, France. 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,
IDX21437 or IDX21459 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, IDX21437 or IDX21459 or any
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; 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, 2013 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 AND COMPREHENSIVE
LOSS |
(IN THOUSANDS, EXCEPT
PER SHARE DATA) |
(UNAUDITED) |
|
|
|
|
|
|
|
Three Months Ended March
31, |
|
2014 |
2013 |
Revenues: |
|
|
Collaboration revenue – related
party |
$ (3,007) |
$852 |
Total revenues |
(3,007) |
852 |
Operating expenses (1): |
|
|
Cost of revenues |
-- |
332 |
Research and development |
21,077 |
24,008 |
General and
administrative |
10,303 |
7,535 |
Total operating expenses |
31,380 |
31,875 |
Loss from operations |
(34,387) |
(31,023) |
Other income, net |
274 |
271 |
Loss before income taxes |
(34,113) |
(30,752) |
Income tax expense |
(1) |
(1) |
Net loss |
$ (34,114) |
$ (30,753) |
Basic and diluted net loss per
share |
($0.24) |
($0.23) |
Shares used in calculation of basic and
diluted net loss per share |
145,118 |
133,958 |
Comprehensive loss: |
|
|
Net loss |
$ (34,114) |
$ (30,753) |
Changes in other comprehensive
income: |
|
|
Foreign currency translation
adjustment |
49 |
(349) |
Comprehensive loss |
$ (34,065) |
$ (31,102) |
(1) Share-based compensation expenses
included in operating expenses amounted to approximately: |
|
|
Research and development |
$483 |
$469 |
General and administrative |
947 |
779 |
|
IDENIX PHARMACEUTICALS,
INC. |
CONDENSED CONSOLIDATED
BALANCE SHEETS |
(IN
THOUSANDS) |
(UNAUDITED) |
|
|
|
|
|
|
|
March 31, |
December 31, |
|
2014 |
2013 |
|
|
|
ASSETS |
|
|
Cash and cash equivalents |
$205,008 |
$122,006 |
Receivables from related party |
1,292 |
1,409 |
Other current assets |
5,600 |
6,337 |
Total current assets |
211,900 |
129,752 |
Property and equipment, net |
2,538 |
2,782 |
Receivables from related party, net of
current portion |
4,842 |
5,082 |
Other assets |
3,852 |
3,395 |
Total assets |
$223,132 |
$141,011 |
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
Accounts payable and accrued expenses |
$20,935 |
$17,084 |
Deferred revenue, related party |
714 |
714 |
Other current liabilities |
279 |
392 |
Total current liabilities |
21,928 |
18,190 |
Other long-term obligations |
13,709 |
13,550 |
Deferred revenue, related party, net of
current portion |
3,095 |
3,274 |
Total liabilities |
38,732 |
35,014 |
Stockholders' equity |
184,400 |
105,997 |
Total liabilities and stockholders'
equity |
$223,132 |
$141,011 |
CONTACT: Idenix Pharmaceuticals Contact:
Teri Dahlman (617) 995-9807
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