Idenix Pharmaceuticals Reports Second Quarter and Six Month 2013 Financial Results

Idenix Pharmaceuticals Reports Second Quarter and Six Month 2013 Financial

CAMBRIDGE, Mass., Aug. 7, 2013 (GLOBE NEWSWIRE) -- 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

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.


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 under
"Events & Presentations".The archived webcast will be available for two weeks
following the call on the Idenix website.


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


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.

                            Three Months Ended June 30, Six Months Ended
                            June 30,                    June 30,
                            2013          2012          2013       2012
Collaboration revenue –      $ 112         $ 1,438       $ 964      $ 1,015
related party
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   ($0.22)       ($0.23)       ($0.45)    ($0.13)
per share:
Shares used in calculation
of basic and diluted net     133,960       108,372       133,959    108,061
loss per share:
Comprehensive loss:                                              
Net loss                     $ (28,919)    $ (25,395)    $ (59,672) $ (13,945)
Changes in other                                                 
comprehensive income:
Foreign currency translation 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

                                                       June 30,  December 31,
                                                       2013      2012
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

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