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Idenix Pharmaceuticals Reports Second Quarter and Six Month
Financial Results
-- Initial results indicate that telbivudine has met the primary endpoint in
the phase III GLOBE study --
CAMBRIDGE, Mass., July 28 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals,
Inc. (NASDAQ:IDIX), a biopharmaceutical company engaged in the discovery,
development and commercialization of drugs for the treatment of human viral and
other infectious diseases, today reported unaudited financial results for the
second quarter and six months ended June 30, 2005.
For the second quarter ended June 30, 2005, Idenix reported total revenues of
$16.1 million, compared with total revenues of $42.8 million in the second
quarter of 2004. Total revenues include reimbursement by Novartis of expenses
incurred by Idenix in connection with the development of telbivudine and
valtorcitabine, Idenix's drug candidates for the treatment of hepatitis B, and
amortization of the up-front fees paid to Idenix in May 2003 when Novartis
licensed Idenix's hepatitis B drug candidates. In the 2004 quarter, total
revenues also included a $25 million milestone payment received from Novartis
related to the successful completion by Idenix of a phase I clinical trial of
valopicitabine, or NM283, Idenix's lead drug candidate for the treatment of
hepatitis C. Idenix reported a net loss of $13.4 million or a loss of $0.28 per
diluted share for the second quarter ended June 30, 2005, compared to net income
of $21.0 million, or $0.53 per diluted share for the second quarter ended June
30, 2004.
For the six months ended June 30, 2005, Idenix reported total revenues of $31.0
million, compared with total revenues of $59.5 million for the six months ended
June 30, 2004. The company reported a net loss of $22.7 million, or a loss of
$0.47 per diluted share for the six months ended June 30, 2005, compared with
net income of $15.1 million, or $0.39 per diluted share for the six months
ended June 30, 2004.
The profitability experienced by the company for the quarter ended and six
months ended June 30, 2004 was due to the recognition of the $25 million
milestone payment received from Novartis during the second quarter of 2004. At
June 30, 2005, Idenix's cash, cash equivalents and marketable securities
totaled $129.1 million.
Business Highlights
"We have achieved significant milestones in our hepatitis B and hepatitis C
development programs over the last three months," said Jean-Pierre Sommadossi,
chairman and chief executive officer of Idenix. "Most significantly, as we
reported in a separate press release today, the initial data indicate that
telbivudine has met the primary efficacy endpoint in the 1,370 patient phase
III GLOBE study. We anticipate finalizing the GLOBE data set shortly and plan
to submit the complete data as a late-breaker abstract to the American
Association for the Study of Liver Diseases for presentation at its annual
meeting in November."
Additionally, the following accomplishments were realized by Idenix over the
last three months:
* The company presented 2-year phase IIb telbivudine data at the 2005
Digestive Disease Week annual meeting that further demonstrated the
correlation between early and profound viral suppression and markers of
improved clinical outcomes.
* The company completed enrollment (with 190 patients) of the phase IIb
clinical trial of valopicitabine in treatment refractory patients. This
clinical trial, which has been extended to 48 weeks, is a head-to-head
trial comparing the combination of valopicitabine plus Pegasys(R) to
ribavirin plus Pegasys(R) in hepatitis C genotype 1 patients who have
previously failed at least 3 months of treatment with pegylated
interferon plus ribavirin, the current standard therapy. Idenix expects
to report preliminary clinical data from this phase IIb trial in the
fall of 2005 and currently anticipates initiating a phase III clinical
trial in this patient population in the first half of 2006.
* The company initiated the phase IIb trial of valopicitabine in
treatment-naive hepatitis C genotype 1 patients at clinical sites in
late July. This trial is designed to quantitatively assess the
antiviral dose-response relationship for valopicitabine in treatment
regimens comprising combinations of Pegasys(R) with various
valopicitabine dosing regimens. The goal of this study is to identify
the optimal combination regimen (valopicitabine plus pegylated
interferon) for further study in phase III trials in treatment naive
patients.
2005 Expectations
Based on the expected timing and cost of current and anticipated clinical
trials and the planned growth of Idenix's commercial operations, the company
currently expects its net use of cash to be between $70 million and $80 million
in 2005, which would result in 2005 year-end cash, cash equivalents and
marketable securities of between $77 million and $87 million.
Conference Call Information
Idenix will hold a conference call today at 4:30 p.m. Eastern time. Company
management will review financial results, provide an update on ongoing clinical
trials, review 2005 corporate milestones and discuss updated financial guidance.
A live webcast of the call will be available on the company's website
http://www.idenix.com/. Please log in approximately 10 minutes before the call
to ensure a timely connection.
About Idenix
Idenix Pharmaceuticals, Inc. (NASDAQ:IDIX) is a biopharmaceutical company
engaged in the discovery, development and commercialization of drugs for the
treatment of human viral and other infectious diseases. Idenix's current focus
is on the treatment of infections caused by hepatitis B virus, hepatitis C
virus and human immunodeficiency virus (HIV). Idenix's headquarters are located
in Cambridge, Massachusetts. The company also has drug discovery and development
operations in Montpellier, France and drug discovery operations in Cagliari,
Italy. For further information about Idenix, please refer to
http://www.idenix.com/.
Forward-looking Statements
This press release contains "forward-looking statements" within the meaning of
The Private Securities Litigation Reform Act of 1995. Such forward-looking
statements can be identified by the use of forward-looking terminology such as
"anticipate," "plan to," "expects," or similar expressions or by express or
implied discussions regarding potential therapeutic benefits and successful
development of telbivudine, valopicitabine and the company's other product
candidates. Such forward-looking statements are subject to numerous factors,
risks and uncertainties that may cause actual events or results to differ
materially from the company's current expectations. These risks and
uncertainties relate to the results of clinical trials and other studies with
respect to telbivudine, valopicitabine and the other product candidates that
the company has under development; the timing and success of submission,
acceptance and approval of regulatory filings; the company's dependence on its
collaboration with Novartis Pharma AG; the company's ability to obtain
additional funding required to conduct its research, development and
commercialization activities; 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 telbivudine, valopicitabine, its other product candidates and its
discoveries. These and other risks are described in greater detail under the
caption "Factors That May Affect Future Results" in the company's quarterly
report on Form 10-Q for the quarter ended March 31, 2005 and filed with the
Securities and Exchange Commission and other filings that the company makes
with the Securities and Exchange Commission.
All forward-looking statements reflect the company's expectations only as of
the date of this release 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. Idenix anticipates that subsequent events and developments may
cause these views, expectations and beliefs to change. However, while Idenix
may elect to update these forward-looking statements at some point in the
future, it specifically disclaims any obligation to do so.
Pegasys(R) is a registered trademark of Hoffmann-La Roche.
Contact:
Idenix Pharmaceuticals, Inc.
Media: Teri Dahlman (617) 995-9905
Investors: Amy Sullivan (617) 995-9838
IDENIX PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT PER SHARE DATA)
(UNAUDITED)
Three Months Ended Six Months Ended
June 30, June 30,
2005 2004 2005 2004
Revenues:
License fees and
collaborative research
and development -
related party $15,983 $42,689 $30,809 $59,319
Government research grants 99 67 176 132
Total revenues 16,082 42,756 30,985 59,451
Operating expenses:
Research and development 23,190 17,684 41,653 36,094
General and administrative 4,749 3,275 9,944 6,737
Sales and marketing 2,414 912 3,833 1,813
Total operating expenses 30,353 21,871 55,430 44,644
(Loss) income from operations (14,271) 20,885 (24,445) 14,807
Investment income, net 803 66 1,622 144
Other expense (2) (1) (2) (2)
(Loss) income before
income taxes (13,470) 20,950 (22,825) 14,949
Income tax benefit 37 --- 126 114
Net (loss) income $(13,433) $20,950 $(22,699) $15,063
Net (loss) income per share:
Basic ($0.28) $0.57 ($0.47) $0.41
Diluted ($0.28) $0.53 ($0.47) $0.39
Shares used in calculation of net loss (income) per share:
Basic 48,119 36,517 48,038 36,495
Diluted 48,119 39,225 48,038 38,924
IDENIX PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS)
(UNAUDITED)
June 30, December 31,
2005 2004
ASSETS
Cash and cash equivalents $46,673 $42,083
Marketable securities 69,897 38,429
Accounts receivable, related party 15,784 16,243
Other current assets 3,068 3,231
Total current assets 135,422 99,986
Property and equipment, net 7,512 6,805
Marketable securities, net of current portion 12,503 76,754
Other assets 4,258 3,573
Total assets $159,695 $187,118
LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable and accrued expenses $18,397 $19,919
Deferred revenue, related party 9,283 9,695
Other current liabilities 344 249
Total current liabilities 28,024 29,863
Long-term obligations 8,426 9,418
Deferred revenue, related party, net of current
position 32,489 38,779
Total liabilities 68,939 78,060
Stockholders' equity 90,756 109,058
Total liabilities and stockholders'
equity $159,695 $187,118
DATASOURCE: Idenix Pharmaceuticals, Inc.
CONTACT: Teri Dahlman, Media, +1-617-995-9905, or Amy Sullivan,
Investors, +1-617-995-9838, both of Idenix Pharmaceuticals, Inc.
Web site: http://www.idenix.com/