Idenix Pharmaceuticals Reports Fourth Quarter and Year End 2009 Financial Results
CAMBRIDGE, Mass., Feb. 25 /PRNewswire-FirstCall/ -- 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 fourth quarter and year ended December 31, 2009. At December 31, 2009, Idenix's cash, cash equivalents and marketable securities totaled $48.1 million.
Business Highlights
- In the fourth quarter of 2009, Idenix initiated a 14-day dose-ranging phase IIa study evaluating IDX184, a once-daily liver-targeted HCV nucleotide prodrug, in combination with pegylated interferon and ribavirin (PegIFN/RBV) in treatment-naïve HCV genotype 1 infected patients. All patients in the 50 mg cohort, the lowest dose in this study, have completed treatment. The mean viral load reduction +/- standard deviation at 14 days for the 50 mg cohort receiving IDX184 in combination with PegIFN/RBV (n=16) was -2.7 +/- 1.3 log10 IU/ml compared to -1.9 +/- 1.1 log10 IU/ml for the group receiving placebo plus PegIFN/RBV (n=4). Two IDX184-treated patients achieved undetectable virus levels (< 15 IU/mL) at Day 14 as well as a third IDX184-treated patient by Day 21 compared to none in the placebo plus PegIFN/RBV group. The safety profile of IDX184 combined with PegIFN/RBV remains consistent with the laboratory and side effect profile of PegIFN/RBV. The study is progressing with enrollment of the 100 mg cohort.
- In January 2010, the company announced data from the first five cohorts (25 mg QD, 50 mg QD, 100 mg QD, 200 mg QD and 200 mg BID) in an ongoing double-blind, placebo-controlled phase I study for IDX375, an HCV non-nucleoside polymerase inhibitor. Data suggest a favorable pharmacokinetic and safety profile in healthy volunteers. This clinical trial was conducted under a European clinical trial application (CTA) using the choline salt form of IDX375. In the first quarter of 2010, Idenix submitted a CTA for a free acid form of IDX375. The active pharmaceutical ingredient as a free acid allows improved manufacturing processes and long-term stability of the drug product, providing diverse formulation options. Idenix plans to continue the phase I program with higher single and multiple doses of the free acid form of IDX375 in healthy volunteers.
- In December 2009, Idenix submitted a CTA for IDX320, an HCV protease inhibitor exhibiting nanomolar potency, broad genotypic coverage and favorable pharmacokinetics in preclinical studies. A double-blind, placebo-controlled phase I clinical trial evaluating single and multiple ascending doses of IDX320 in healthy volunteers is ongoing.
- In 2009, GSK2248761/IDX899, a non-nucleoside reverse transcriptase inhibitor for the treatment of HIV-1, progressed through long-term chronic toxicology studies and drug-drug interaction studies in healthy volunteers with a favorable safety and drug-drug interaction profile. A broad phase IIb clinical development program is anticipated to begin in 2010.
"We are pleased with the progress our partner, GlaxoSmithKline, has achieved with GSK2248761 and with our accomplishment of advancing three clinical candidates from major HCV drug classes to human testing. We look forward to GSK's initiation of phase IIb studies with GSK2248761 and multiple data readouts from our HCV programs throughout the year," said Jean-Pierre Sommadossi, Ph.D., chairman and chief executive officer of Idenix. "In 2010, as the profiles of our HCV drug candidates continue to emerge, we will seek to build a combination drug development strategy, both internally and with partners, to advance the future HCV treatment paradigm."
Fourth Quarter and Full Year 2009 Financial Results
For the fourth quarter ended December 31, 2009, Idenix reported total revenues of $3.0 million, compared to total revenues of $4.3 million in the fourth quarter of 2008. The company reported a net loss of $12.3 million, or a loss of $0.19 per basic and diluted share, for the fourth quarter ended December 31, 2009, compared to a net loss of $13.9 million, or a loss of $0.25 per basic and diluted share for the fourth quarter ended December 31, 2008.
For the twelve months ended December 31, 2009, Idenix reported total revenues of $12.6 million, compared to total revenues of $10.0 million for the twelve months ended December 31, 2008. The majority of the increase was due to additional license fee revenue and royalty revenue recognized, related to our collaborations with GlaxoSmithKline and Novartis Pharma AG, as compared to the same period in 2008. The company reported a net loss of $53.2 million, or a loss of $0.87 per basic and diluted share for the twelve months ended December 31, 2009, compared to $70.2 million, or a loss of $1.24 per basic and diluted share for the twelve months ended December 31, 2008. The change in net loss was primarily a result of lower operating expenses in 2009 as compared to 2008.
2010 Financial Guidance
The company expects that its current cash, cash equivalents and marketable securities can fund operations through at least the next twelve months. This guidance assumes no milestone payments, license fees, reimbursement for development programs and no financing activities.
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 54113451. To listen to a live webcast of the call, go to "Calendar of Events" in the Idenix Investor Center at 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 March 11, 2010. To access the replay, please dial (800) 642-1687 U.S./Canada or (706) 645-9291 International and enter the passcode 54113451.
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 infections caused by the hepatitis C virus. For further information about Idenix, please refer to www.idenix.com.
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 "expects," "plans," "anticipates," "will," "estimates," "projects," "would," "could," "targets," and similar expressions are also intended to identify forward-looking statements, as are 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, future royalty payments and cash balances at the end of 2009. 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: there can be no guarantees that historical sales of Tyzeka®/Sebivo® (telbivudine) 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; 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 collaborations with Novartis Pharma AG and GlaxoSmithKline; 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 quarterly report on Form 10-Q for the quarter ended September 30, 2009 as filed with the Securities and Exchange Commission (SEC), and in any subsequent periodic or current reports 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.
IDENIX PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT PER SHARE DATA)
(UNAUDITED)
Three Months Ended Years Ended
------------------ -----------
December 31, December 31,
------------ ------------
2009 2008 2009 2008
---- ---- ---- ----
Revenues:
Collaboration revenue –
related party $2,780 $4,247 $11,717 $9,815
Other revenue 269 21 899 234
------ ----- ----- -----
Total revenues 3,049 4,268 12,616 10,049
Operating expenses (1):
Cost of revenues 710 479 2,210 1,745
Research and development 10,268 11,949 41,867 53,887
General and administrative 4,889 5,702 21,467 27,130
Restructuring and impairment
charges - - 1,506 297
------ ----- ----- -----
Total operating expenses 15,867 18,130 67,050 83,059
------ ------ ------ ------
Loss from operations (12,818) (13,862) (54,434) (73,010)
Other income (expense), net 502 (110) 1,188 2,755
------ ----- ----- -----
Loss before income taxes (12,316) (13,972) (53,246) (70,255)
Income tax benefit 4 23 27 49
------ ----- ----- -----
Net loss $(12,312) $(13,949) $(53,219) $(70,206)
======== ======== ======== ========
Basic and diluted net loss per
share: ($0.19) ($0.25) ($0.87) ($1.24)
====== ====== ====== ======
Shares used in calculation of
basic and diluted net loss
per share: 66,357 56,524 61,498 56,403
====== ====== ====== ======
(1) Share-based compensation expenses included in operating expenses
amounted to approximately:
Research and development $336 $440 $1,546 $2,005
General and administrative 724 790 3,069 3,397
IDENIX PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS)
(UNAUDITED)
December 31, December 31,
2009 2008
------- -------
ASSETS
Cash and cash equivalents $46,519 $41,509
- 1,424
Marketable securities 1,049 894
Receivables from related party 4,012 6,214
------- -------
Other current assets
Total current assets 51,580 50,041
Intangible asset, net 11,069 12,387
Property and equipment, net 10,091 13,238
Marketable securities 1,584 3,145
Other assets 2,326 969
------- -------
Total assets $76,650 $79,780
======= =======
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
Accounts payable and accrued expenses $10,720 $13,136
Deferred revenue, related party 6,155 5,965
Other current liabilities 1,469 475
------- -------
Total current liabilities 18,344 19,576
Long-term obligations 32,983 17,061
Deferred revenue, related party, net of
current portion 30,776 35,790
------- -------
Total liabilities 82,103 72,427
Stockholders' equity (deficit) (5,453) 7,353
------- -------
Total liabilities and stockholders'
equity (deficit) $76,650 $79,780
======= =======
Idenix Pharmaceuticals Contact:
Teri Dahlman (617) 995-9905
SOURCE Idenix Pharmaceuticals, Inc.
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