Idenix Pharmaceuticals Reports Fourth Quarter and Year Ended 2013 Financial Results
February 27 2014 - 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 year ended December 31, 2013.
HCV Pipeline Review
- In January 2014, Idenix initiated the seven-day
proof-of-concept portion of a phase I/II clinical trial for
IDX21437, its lead uridine-based nucleotide prodrug candidate. Data
are expected in the first half of 2014.
- In December 2013, Idenix initiated a second 12-week phase II
clinical trial in its collaboration with Janssen Pharmaceuticals,
Inc. The HELIX-2 study is evaluating samatasvir, simeprevir and
TMC647055/r, with and without ribavirin in genotype 1-infected
patients who are either treatment-naïve or have previously relapsed
after treatment with interferon and ribavirin. Initiation of
HELIX-2 is supported by interim data recently reported from the
ongoing 12-week phase II HELIX-1 study from the Janssen
collaboration, which is evaluating the combination of samatasvir
and simeprevir plus ribavirin. Data from the HELIX-2 trial are
expected in the second half of 2014.
Business Review
- In January 2014, Idenix issued 16.4 million shares of its
common stock to The Baupost Group, L.L.C. resulting in net proceeds
to Idenix of $106.7 million.
- In January 2014, Idenix appointed Jacques Dumas, Ph.D., as its
Executive Vice President and Chief Scientific Officer. Dr. Dumas
brings over 20 years of experience in infectious disease and
oncology discovery and development, most recently as Vice President
and Head of Strategy, Infection Innovative Medicines at AstraZeneca
plc.
- In January 2014, Idenix filed an action in the United States
District Court for the District of Delaware to challenge a decision
made by the U.S. Patent and Trademark Office (USPTO) in the first
patent interference proceeding (No. 105,871) concerning one of the
Company's patent applications (U.S. Patent Application 12/131,868)
and an issued patent (U.S. Patent 7,429,572) owned by Gilead
Sciences, Inc. that covers certain 2'-methyl- 2'-fluoro nucleoside
compounds useful in the treatment of HCV.
- In December 2013, the USPTO declared a second patent
interference between Idenix's U.S. Patent 7,608,600 and Gilead
Sciences, Inc.'s U.S. Patent Application 11/854,218, both related
to the use of certain 2'-methyl, 2'-fluoro nucleoside compounds to
treat HCV infections.
- In December 2013, Idenix filed two lawsuits against Gilead
Sciences, Inc.: a patent infringement lawsuit in the U.S. District
Court in Boston, Massachusetts and a separate patent infringement
and interference lawsuit in the U.S. District Court in Wilmington,
Delaware.
"In the fourth quarter of 2013 and early part of 2014, Idenix
made significant progress across all aspects of our business, the
most important of which was to advance our nucleotide prodrug
candidate, IDX21437, into clinical trials which will support our
ultimate goal of developing an all-oral pan-genotypic combination
regimen for HCV," said Ron Renaud, Idenix's President and Chief
Executive Officer. "With the advancement of our two HCV clinical
programs, we remain on track to initiate an Idenix-sponsored
combination clinical trial of samatasvir and IDX21437 by mid-2014.
Further, we have continued to demonstrate our resolve in
aggressively protecting our intellectual property in HCV."
Fourth Quarter and Year Ended 2013 Financial
Results
For the fourth quarter ended December 31, 2013, Idenix reported
total revenues of ($0.5) million, compared to total revenues of
$0.3 million in the fourth quarter of 2012. The Company reported a
net loss of $28.7 million, or $0.21 per basic and diluted share,
for the fourth quarter ended December 31, 2013, compared to a net
loss of $22.7 million, or $0.17 per basic and diluted share for the
fourth quarter ended December 31, 2012.
For the year ended December 31, 2013, Idenix reported total
revenues of $0.5 million, compared to total revenues of $69.7
million for the year ended December 31, 2012. The Company reported
a net loss of $122.3 million, or $0.91 per basic and diluted share,
for the year ended December 31, 2013, compared to a net loss of
$32.4 million, or $0.27 per basic and diluted share for the year
ended December 31, 2012. The change in net loss was mainly due to
less revenue in 2013 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 and the recognition of $33.1 million of collaboration
revenue in 2012 primarily related to the termination and revised
relationship agreement executed in July 2012 with Novartis.
Additionally, there were increases of $14.1 million in research and
development expenses mainly due to the advancement of our drug
candidates and $11.1 million in general and administrative expenses
mainly due to patent interference and litigation costs.
2014 Financial Guidance
At December 31, 2013, Idenix's cash and cash equivalents totaled
$122.0 million. The Company expects that its current cash and cash
equivalents and the net proceeds from the January 2014 registered
direct offering of $106.7 million will be sufficient to sustain its
operations into at least the second half of 2015. This guidance
excludes milestone payments or license fees, reimbursement for
development programs and additional 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.
ABOUT THE IDENIX/JANSSEN COLLABORATION
In January 2013, Idenix entered into a non-exclusive
collaboration with Janssen Pharmaceuticals for the clinical
development of all-oral direct-acting antiviral (DAA) HCV
combination therapies. The collaboration is evaluating combinations
including samatasvir (IDX719), Idenix's once-daily pan-genotypic
NS5A inhibitor, simeprevir (TMC435), a once-daily protease
inhibitor jointly developed by Janssen R&D Ireland and Medivir
AB, and TMC647055, a once-daily NS5B non-nucleoside polymerase
inhibitor boosted with low-dose ritonavir being developed by
Janssen R&D Ireland. The HELIX-1 and HELIX-2 clinical trials
are being conducted by Idenix. Both Idenix and Janssen retain all
rights to their respective compounds under the agreement.
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 IDX21437,
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, IDX21437or our other drug candidates; the
outcome of any legal action; 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 September 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.
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IDENIX
PHARMACEUTICALS, INC. |
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CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME
(LOSS) |
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(IN THOUSANDS, EXCEPT
PER SHARE DATA) |
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(UNAUDITED) |
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Three Months Ended |
Years Ended |
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December 31, |
December 31, |
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2013 |
2012 |
2013 |
2012 |
Revenues: |
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Collaboration revenue –
related party |
$ (514) |
$ 327 |
$ 469 |
$ 33,595 |
Other revenue |
----- |
----- |
----- |
36,068 |
Total revenues |
(514) |
327 |
469 |
69,663 |
Operating expenses (1): |
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Cost of revenues |
----- |
352 |
715 |
2,654 |
Research and
development |
18,794 |
17,578 |
84,254 |
70,182 |
General and
administrative |
10,014 |
7,364 |
35,320 |
24,163 |
Restructuring
charges |
----- |
----- |
3,900 |
----- |
Intangible asset
impairment |
----- |
----- |
----- |
8,045 |
Total operating
expenses |
28,808 |
25,294 |
124,189 |
105,044 |
Loss from operations |
(29,322) |
(24,967) |
(123,720) |
(35,381) |
Other income, net |
578 |
2,152 |
1,350 |
2,892 |
Loss before income taxes |
(28,744) |
(22,815) |
(122,370) |
(32,489) |
Income tax benefit |
84 |
90 |
83 |
89 |
Net loss |
$ (28,660) |
$ (22,725) |
$ (122,287) |
$ (32,400) |
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Basic and diluted net loss per
share |
$ (0.21) |
$ (0.17) |
$ (0.91) |
$ (0.27) |
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Shares used in calculation of basic and
diluted net loss per share |
134,032 |
133,897 |
133,980 |
118,755 |
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Comprehensive loss: |
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Net loss |
$ (28,660) |
$ (22,725) |
$ (122,287) |
$ (32,400) |
Changes in other
comprehensive income: |
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Foreign currency
translation adjustment |
115 |
194 |
389 |
105 |
Comprehensive loss |
$ (28,545) |
$ (22,531) |
$ (121,898) |
$ (32,295) |
(1) Share-based compensation expenses
included in operating expenses amounted to approximately: |
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Research and
development |
$371 |
$533 |
$1,753 |
$1,810 |
General and
administrative |
832 |
1,150 |
3,307 |
3,026 |
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IDENIX PHARMACEUTICALS,
INC. |
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CONDENSED CONSOLIDATED
BALANCE SHEETS |
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(IN
THOUSANDS) |
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(UNAUDITED) |
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December 31, |
December 31, |
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2013 |
2012 |
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ASSETS |
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Cash and cash equivalents |
$122,006 |
$230,826 |
Receivables from related party |
1,409 |
1,195 |
Other current assets |
6,337 |
5,771 |
Total current assets |
129,752 |
237,792 |
Property and equipment, net |
2,782 |
3,274 |
Receivables from related party, net of
current portion |
5,082 |
6,210 |
Other assets |
3,395 |
3,589 |
Total assets |
$141,011 |
$250,865 |
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LIABILITIES AND STOCKHOLDERS' EQUITY |
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Accounts payable and accrued expenses |
$17,084 |
$15,064 |
Deferred revenue, related party |
714 |
714 |
Other current liabilities |
392 |
154 |
Total current
liabilities |
18,190 |
15,932 |
Other long-term obligations |
13,550 |
11,785 |
Deferred revenue, related party, net of
current portion |
3,274 |
3,988 |
Total liabilities |
35,014 |
31,705 |
Stockholders' equity |
105,997 |
219,160 |
Total liabilities and
stockholders' equity |
$141,011 |
$250,865 |
CONTACT: Idenix Pharmaceuticals Contact:
Teri Dahlman (617) 995-9807
(MM) (NASDAQ:IDIX)
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