CAMBRIDGE, Mass., Nov. 6 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX), a biopharmaceutical company engaged in the discovery and development 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, 2007. At September 30, 2007, Idenix's cash, cash equivalents and marketable securities totaled approximately $136.5 million.
For the third quarter ended September 30, 2007, Idenix reported total revenues of $10.9 million, compared with total revenues of $19.6 million in the third quarter of 2006. Total revenues for the third quarter of 2007 consist of reimbursement by Novartis Pharma AG of expenses incurred by Idenix in connection with the development of Tyzeka(R)/Sebivo(R) (telbivudine), valtorcitabine and valopicitabine, Idenix's product and product candidates for the treatment of hepatitis B virus (HBV) and hepatitis C virus (HCV), respectively, and the amortization of the up-front fees received by Idenix in connection with Novartis' license of telbivudine, valtorcitabine and valopicitabine and product sales of Tyzeka/Sebivo. Idenix reported a net loss of $30.5 million, or a loss of $0.54 per basic and diluted share for the third quarter ended September 30, 2007, compared to a net loss of $19.7 million, or a loss of $0.35 per basic and diluted share for the third quarter ended September 30, 2006. Included in the net loss for the third quarter ended September 30, 2007 was a $6.4 million restructuring charge primarily related to severance costs and impairment of certain fixed assets related to the transition of commercialization, development and manufacturing activities for telbivudine to Novartis. Idenix currently expects to incur approximately $3 million to $5 million in additional charges relating to this restructuring over the next two quarters. Also in connection with the restructuring, the company accelerated the depreciation of certain assets equal to approximately $1.9 million in the quarter ended September 30, 2007 and expects to record approximately an additional $1 million of accelerated depreciation charges in the fourth quarter of 2007.
For the nine months ended September 30, 2007, Idenix reported total revenues of $55.4 million, compared with total revenues of $52.1 million for the nine months ended September 30, 2006. The company reported a net loss of $65.0 million, or a loss of $1.16 per basic and diluted share for the nine months ended September 30, 2007, compared with $51.5 million, or a loss of $0.92 per basic and diluted share for the nine months ended September 30, 2006.
Significant events in the last quarter include:
-- Announced a strategic restructuring whereby Novartis, Idenix's
collaboration partner, effective October 1, 2007, assumed full
responsibility for the development, manufacturing and commercialization
activities relating to Tyzeka/Sebivo, including ongoing and future
clinical trials and regulatory filings. In place of the previous
revenue sharing arrangement, Idenix will receive a royalty on worldwide
product sales. As a result of these changes, Idenix is reducing its
workforce by approximately 100 positions, the majority of which
supported the development and commercialization of Tyzeka/Sebivo in the
United States and Europe. Idenix estimates that this restructuring will
result in savings of $40 million to $45 million, including associated
third party and marketing costs, on an annualized basis.
-- Completed a single-dose pharmacokinetic (PK) study and a 7-day multi-
dose study in healthy volunteers for the company's non-nucleoside
reverse transcriptase inhibitor (NNRTI) candidate IDX899 for the
treatment of HIV. The full preclinical data and these first human data
were submitted for presentation at the Conference on Retroviruses and
Opportunistic Infections (CROI), which will be held in February 2008.
"While this has been a challenging time in the evolution of Idenix, we continue to be optimistic about the company's future," said Jean-Pierre Sommadossi, Ph.D., chairman and chief executive officer of Idenix. "The restructuring will allow us to devote our resources to the discovery and development of antiviral drugs for the treatment of HCV and HIV. We have had active HCV and HIV discovery programs underway for the past 18 months and are very excited about the candidates in our pipeline."
2007 Financial Guidance
Idenix continues to expect to end 2007 with between $100 million and $110 million of cash, cash equivalents and marketable securities.
Conference Call and Webcast Information
Idenix will hold a conference call today at 4:30 p.m. ET. To access the call please dial 800-471-3635 U.S./Canada or 706-758-9475 International and enter passcode 21545602. To listen to a live webcast of the call, go to "Calendar of 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. A replay of the conference call and webcast will be available until November 20, 2007. To access the replay, please dial 800-642-1687 U.S./Canada or 706-645-9291 International and enter the passcode 21545602.
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 and other infectious diseases. Idenix's current focus is on the treatment of infections caused by hepatitis C virus and HIV. 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 "expect," "may," "plans," "will," or similar expressions, or by express or implied statements with respect to the company's clinical development programs or commercialization activities in HIV or hepatitis C, or any potential pipeline candidates and expectations with respect to additional milestone payments and cash balances at the end of 2007. 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. There can be no guarantees that historical sales of Tyzeka/Sebivo will in any way suggest future royalty payments or royalty rates owed to the company, or 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. In particular, 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 dependence on its collaboration with Novartis Pharma AG; 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. These and other risks which may impact management's expectations are described in greater detail under the caption "Risk Factors" in the company's annual report on Form 10-K for the year ended December 31, 2006 and the Quarterly Report on Form 10- Q for the quarter ended June 30, 2007, each as filed with the Securities and Exchange Commission (SEC) and other filings that the company makes with the SEC.
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.
Idenix Pharmaceuticals' Contacts:
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)
Three Months Ended Nine Months Ended
September 30, September 30,
2007 2006 2007 2006
- related party $9,153 $19,590 $52,178 $51,898
Product sales 1,725 ----- 3,188 -----
Government research grants 10 55 60 171
Total revenues 10,888 19,645 55,426 52,069
Operating expenses (1):
Cost of sales 277 ----- 514 -----
Research and development 18,421 26,083 65,545 73,013
Selling, general and
administrative 18,393 15,924 54,070 38,727
Restructuring and impairment
charges 6,439 ------- 6,439 -------
Total operating expenses 43,530 42,007 126,568 111,740
Loss from operations (32,642) (22,362) (71,142) (59,671)
Investment income, net 1,718 2,563 5,498 7,217
Loss before income taxes (30,924) (19,799) (65,644) (52,454)
Income tax benefit 375 84 624 948
Net loss $(30,549) $(19,715) $(65,020) $(51,506)
Basic and diluted net loss
per share: ($0.54) ($0.35) ($1.16) ($0.92)
Shares used in calculation
of basic and diluted net
loss per share: 56,189 56,058 56,162 55,981
(1) Stock-based compensation
expenses included in operating
expenses amounted to
Research and development $553 $713 $2,444 $2,246
Selling, general and
administrative 1,326 1,830 3,859 4,527
Restructuring and impairment
charges 968 ----- 968 -----
IDENIX PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
September 30, December 31,
Cash and cash equivalents $51,285 $55,892
Marketable securities 52,519 71,251
Receivables from related party 7,758 12,035
Other current assets 7,527 8,427
Total current assets 119,089 147,605
Property and equipment, net 17,261 17,448
Marketable securities, non-current 32,678 59,208
Other assets 8,772 4,204
Total assets $177,800 $228,465
LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable and accrued expenses $29,276 $23,429
Deferred revenue, related party 9,123 13,490
Other current liabilities 500 527
Total current liabilities 38,899 37,446
Long-term obligations 7,422 8,523
Deferred revenue, related party, net of
current position 43,335 40,471
Total liabilities 89,656 86,440
Stockholders' equity 88,144 142,025
Total liabilities and stockholders' equity $177,800 $228,465
|SOURCE Idenix Pharmaceuticals, Inc.|
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