CAMBRIDGE, Mass., Nov. 3 /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 third
quarter and nine months ended September 30, 2005. For the third
quarter ended September 30, 2005, Idenix reported total revenues of
$15.6 million, compared with total revenues of $17.2 million in the
third 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 product
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 product candidates. Idenix reported a net loss
of $13.7 million, or a loss of $0.28 per diluted share for the
third quarter ended September 30, 2005, compared to a net loss of
$7.4 million, or a loss of $0.17 per diluted share for the third
quarter ended September 30, 2004. For the nine months ended
September 30, 2005, Idenix reported total revenues of $46.6
million, compared with total revenues of $76.6 million for the nine
months ended September 30, 2004. The company reported a net loss of
$36.4 million, or a loss of $0.76 per diluted share for the nine
months ended September 30, 2005, compared with net income of $7.7
million, or $0.19 per diluted share for the nine months ended
September 30, 2004. Total revenues in the 2004 period included a
$25 million milestone payment received from Novartis related to
valopicitabine, or NM283, Idenix's product candidate for the
treatment of hepatitis C. The company's profitability for the nine
months ended September 30, 2004 was attributable to the recognition
of this $25 million milestone payment. At September 30, 2005,
Idenix's cash, cash equivalents and marketable securities totaled
$114.9 million. Business Highlights "The last four months have been
very productive for Idenix," said Jean- Pierre Sommadossi, chairman
and chief executive officer of Idenix. "We reported positive data
from both our hepatitis B and hepatitis C programs and completed a
successful follow-on offering." The following accomplishments were
realized by Idenix over the last four months: * The company
reported data from the phase III GLOBE study of telbivudine. After
1 year of treatment, the data indicate that telbivudine, when
compared to lamivudine, showed statistically significantly greater
efficacy on all virologic endpoints evaluated in this study in both
HBeAg-positive and HBeAg-negative patients. Telbivudine met
superiority criteria for the primary clinical efficacy endpoint of
therapeutic response in HBeAg-positive patients and met
non-inferiority criteria on the therapeutic response endpoint in
HBeAg-negative patients. Both treatments were well tolerated;
however, patients treated with telbivudine showed significantly
less resistance and fewer ALT flares as compared to lamivudine.
Transient creatine kinase (CK) elevations, not requiring treatment
modification, were more common with telbivudine as compared to
lamivudine. In the GLOBE study, the most frequently reported
adverse events, regardless of attributability to study treatment,
were upper respiratory infection and fatigue, which were equally
common for telbivudine and lamivudine. * The company also reported
positive interim data from the phase IIb clinical trial of
valopicitabine in treatment-refractory patients. This clinical
trial is a head-to-head study comparing the combination of
valopicitabine and Pegasys(R) to ribavirin and 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. The data at week 4 and week 12 of
treatment indicate that patients treated with valopicitabine
combined with Pegasys(R) showed statistically significant
improvements in suppression of HCV replication and in rates of
early virologic response as compared to patients retreated with
Pegasys(R) and ribavirin. Early virologic response is defined as
reduction of at least 2 log10, or greater than 99%, from the
baseline levels of HCV RNA in a patient's blood. In this trial,
valopicitabine has demonstrated satisfactory safety and tolerance
overall, to date. A low percentage of patients have discontinued
due to adverse events. Two discontinuations due to serious adverse
events were considered attributable to study treatment (anemia and
dehydration) and both resolved. To date, there is no predominant
treatment-limiting adverse event or laboratory abnormality. * In
October 2005, the company completed an underwritten public offering
and sold 7,278,020 shares of its common stock at a price of $20.61
per share, including 3,939,131 shares to Novartis Pharma AG,
resulting in net proceeds to the company of approximately $145.5
million. Following the offering, Novartis owns approximately 56% of
Idenix's outstanding common stock. "We anticipate the high level of
activity at Idenix to continue through year-end, with five
presentations of currently available data scheduled at the annual
meeting of the American Association for the Study of Liver Diseases
in November, the anticipated submission of a new drug application
with the U.S. Food and Drug Administration, or FDA, for telbivudine
in December, and a scheduled end of phase IIb meeting with the FDA
in late November for valopicitabine," Sommadossi continued. "The
results of the end of phase IIb meeting with the FDA will help
define our plans for a phase III registration trial of
valopicitabine in treatment-refractory, genotype-1 hepatitis C
patients, which we currently anticipate beginning by the end of the
first quarter of 2006." 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 $65 million and
$73 million in 2005, which would result in 2005 year-end cash, cash
equivalents and marketable securities of between $229 million and
$237 million, including the net proceeds of approximately $145.5
million from the recently completed public offering. Conference
Call Information Idenix will hold a conference call today at 4:30
p.m. Eastern time. To access the call please dial 800-774-5358
US/Canada or 706-643-0743 International and enter passcode 1725059
or to listen to a live webcast of the call, go to "Events" in the
Idenix Investor Center at http://www.idenix.com/. Please log in
approximately 10 minutes before the call to ensure a timely
connection. An archived webcast will be available on the Idenix
website for two weeks after the call. A replay of the call will
also be available from 8:00 p.m. ET on November 3, 2005, until 8:00
p.m. ET on November 17, 2005. To access the replay, please dial
800-642-1687 or 706-645-9291 (international), and provide the
passcode 1725059. 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 and regulatory approval 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 in Exhibit 99.2 to the
company's current report on Form 8-K filed on October 25, 2005 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. IDENIX
PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (IN THOUSANDS, EXCEPT PER SHARE DATA) (UNAUDITED) Three
Months Ended Nine Months Ended September 30, September 30, 2005
2004 2005 2004 Revenues: License fees and collaborative research
and development - related party $15,506 $17,052 $46,315 $76,371
Government research grants 124 127 300 259 Total revenues 15,630
17,179 46,615 76,630 Operating expenses: Research and development
21,488 19,048 63,141 55,142 General and administrative 4,800 4,205
14,744 10,942 Sales and marketing 4,222 1,840 8,055 3,653 Total
operating expenses 30,510 25,093 85,940 69,737 (Loss) income from
operations (14,880) (7,914) (39,325) 6,893 Investment income, net
717 521 2,339 665 Other (expense) income (2) 1 (4) (1) (Loss)
income before income taxes (14,165) (7,392) (36,990) 7,557 Income
tax benefit 467 39 593 153 Net (loss) income $(13,698) $(7,353)
$(36,397) $7,710 Net (loss) income per share: Basic ($0.28) ($0.17)
($0.76) $0.20 Diluted ($0.28) ($0.17) ($0.76) $0.19 Shares used in
calculation of net loss (income) per share: Basic 48,220 44,520
48,100 39,190 Diluted 48,220 44,520 48,100 41,361 IDENIX
PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (IN
THOUSANDS) (UNAUDITED) September 30, December 31, 2005 2004 ASSETS
Cash and cash equivalents $ 41,807 $ 42,083 Restricted cash 411 -
Marketable securities 61,042 38,429 Accounts receivable, related
party 16,660 16,243 Other current assets 4,166 3,231 Total current
assets 124,086 99,986 Property and equipment, net 9,793 6,805
Marketable securities, net of current portion 12,001 76,754 Other
assets 4,724 3,573 Total assets $ 150,604 $ 187,118 LIABILITIES AND
STOCKHOLDERS' EQUITY Accounts payable and accrued expenses $ 22,574
$ 19,919 Deferred revenue, related party 8,683 9,695 Other current
liabilities 406 249 Total current liabilities 31,663 29,863
Long-term obligations 8,937 9,418 Deferred revenue, related party,
net of current position 28,219 38,779 Total liabilities 68,819
78,060 Stockholders' equity 81,785 109,058 Total liabilities and
stockholders' equity $150,604 $187,118 Contact: Idenix
Pharmaceuticals, Inc. Media: Teri Dahlman (617) 995-9905 Investors:
Amy Sullivan (617) 995-9838 DATASOURCE: Idenix Pharmaceuticals,
Inc. CONTACT: Teri Dahlman, +1-617-995-9905, or Amy Sullivan,
+1-617-995-9838 both of Idenix Pharmaceuticals, Inc. Web site:
http://www.idenix.com/
Copyright
(MM) (NASDAQ:IDIX)
Historical Stock Chart
From Jun 2024 to Jul 2024
(MM) (NASDAQ:IDIX)
Historical Stock Chart
From Jul 2023 to Jul 2024