Idenix Pharmaceuticals, Inc. Reports Third Quarter And Nine Month Financial Results
CAMBRIDGE, Mass., Nov. 3 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. , 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.
"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."
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.
Idenix Pharmaceuticals, Inc. 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.
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) 995-9838Idenix Pharmaceuticals, Inc.
CONTACT: Teri Dahlman, +1-617-995-9905, or Amy Sullivan, +1-617-995-9838both of Idenix Pharmaceuticals, Inc.
Web site: http://www.idenix.com//