Idenix Pharmaceuticals Reports First Quarter 2012 Financial Results and HCV Development Program Progress
May 02 2012 - 4:05PM
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, 2012 and
progress of its hepatitis C virus (HCV) development programs.
Operational Highlights
IDX184 Program, an HCV nucleotide polymerase
inhibitor
- The company reported interim data for the first cohort of 31
patients from an ongoing 12-week phase IIb clinical trial of IDX184
in combination with pegylated interferon and ribavirin (PegIFN/RBV)
which demonstrated favorable safety and potent antiviral activity
at 12 weeks of treatment.
- The company has completed enrollment of the second cohort of 30
additional patients after the U.S. Food and Drug Administration
removed the partial clinical hold on IDX184 in February. To date,
IDX184 continues to be well tolerated with a safety profile similar
to the known side effect profile for PegIFN/RBV treatment.
IDX719 Program, an HCV NS5A inhibitor
- The company completed a single-ascending dose study in healthy
volunteers and genotype 1, 2 and 3 HCV-infected patients. IDX719
was well tolerated and demonstrated potent pan-genotypic antiviral
activity with more than 3 log10 viral load reductions achieved in
the 100 mg dose group.
- A three-day proof-of-concept segment of the study in
treatment-naïve genotype 1, 2, 3 or 4 HCV-infected patients is
ongoing.
Nucleotide Discovery Program
- Idenix selected IDX19368 as its lead candidate and expects to
submit an investigational new drug application for IDX19368 in
mid-2012.
"The first quarter has been a productive one for Idenix as our
three HCV development programs continued to move forward," said Ron
Renaud, Idenix's President and Chief Executive Officer. "We are on
track to achieve our near-term goals of initiating our first
all-oral DAA combination trial for IDX184 and a protease inhibitor,
generating IDX719 proof-of-concept data and moving IDX19368 into
the clinic. As we continue to advance our programs, we continue to
build on the promising profiles of our HCV candidates as potential
components of future HCV combination treatments."
First Quarter Ended 2012 Financial Results
For the first quarter ended March 31, 2012, Idenix reported
total revenues of $35.6 million, compared to total revenues of $4.0
million in the first quarter of 2011. The Company reported a net
income of $11.4 million, or $0.11 per basic share and $0.10 per
diluted share, for the first quarter ended March 31, 2012, compared
to a net loss of $8.2 million, or $0.11 per basic and diluted share
for the first quarter ended March 31, 2011. In the first quarter
ended March 31 2012, Idenix reported net income due to the
recognition of $36.1 million of deferred revenue related to the
termination of the license agreement with ViiV Healthcare Company
on March 15, 2012. However, the Company expects to report a net
loss for the year ending December 31, 2012 and for the next several
years as it continues to expand its drug discovery and development
efforts.
2012 Financial Guidance
At March 31, 2012, Idenix's cash and cash equivalents totaled
$105.3 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 December 31, 2012. 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.
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,
IDX19368 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, 2011 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 INCOME
(LOSS) |
|
|
|
(IN THOUSANDS, EXCEPT
PER SHARE DATA) |
|
|
|
(UNAUDITED) |
|
|
|
|
Three Months Ended March
31, |
|
2012 |
2011 |
Revenues: |
|
|
Collaboration revenue – related
party |
(423) |
3,345 |
Other revenue |
36,068 |
656 |
Total revenues |
35,645 |
4,001 |
Operating expenses (1): |
|
|
Cost of revenues |
1,170 |
547 |
Research and development |
18,593 |
8,083 |
General and
administrative |
4,774 |
3,914 |
Total operating expenses |
24,537 |
12,544 |
Income (loss) from operations |
11,108 |
(8,543) |
Other income, net |
342 |
308 |
Income (loss) before income taxes |
11,450 |
(8,235) |
Income tax expense |
(1) |
(1) |
Net income (loss) |
$11,449 |
$(8,236) |
Earnings (loss) per common
share: |
|
Basic |
$ 0.11 |
$ (0.11) |
Diluted |
$ 0.10 |
$ (0.11) |
Weighted average number of common
shares outstanding: |
Basic |
107,751 |
73,118 |
Diluted |
112,330 |
73,118 |
Comprehensive income (loss): |
|
Net income (loss) |
$ 11,449 |
$ (8,236) |
Changes in other
comprehensive income: |
|
Foreign currency translation
adjustment |
208 |
278 |
Comprehensive income (loss) |
$ 11,657 |
$ (7,958) |
(1) Share-based compensation
expenses included in operating expenses amounted to
approximately: |
Research and development |
$298 |
$271 |
General and administrative |
432 |
326 |
|
IDENIX PHARMACEUTICALS,
INC. |
|
|
|
CONDENSED CONSOLIDATED
BALANCE SHEETS |
|
|
|
(IN
THOUSANDS) |
|
|
|
(UNAUDITED) |
|
|
|
|
|
|
|
March 31, 2012 |
December 31, 2011 |
|
|
|
ASSETS |
|
|
Cash and cash equivalents |
$105,258 |
$118,271 |
Receivables from related party |
1,214 |
1,157 |
Other current assets |
3,361 |
4,410 |
Total current assets |
109,833 |
123,838 |
Intangible asset, net |
8,424 |
8,708 |
Property and equipment, net |
4,550 |
4,696 |
Other assets |
4,334 |
3,802 |
Total assets |
$127,141 |
$141,044 |
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
Accounts payable and accrued expenses |
$15,430 |
$11,299 |
Deferred revenue, related party |
2,796 |
2,897 |
Other current liabilities |
397 |
36,329 |
Total current liabilities |
18,623 |
50,525 |
Other long-term obligations |
14,698 |
14,912 |
Deferred revenue, related party, net of
current portion |
22,834 |
24,382 |
Total liabilities |
56,155 |
89,819 |
Stockholders' equity |
70,986 |
51,225 |
Total liabilities and stockholders'
equity |
$127,141 |
$141,044 |
CONTACT: Idenix Pharmaceuticals Contacts:
Kelly Barry (617) 995-9033 (media)
Teri Dahlman (617) 995-9807 (investors)
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