Idenix Pharmaceuticals Reports Second Quarter and Six Month 2012 Financial Results and HCV Program Update

Wed Aug 8, 2012 4:05pm EDT

* Reuters is not responsible for the content in this press release.

CAMBRIDGE, Mass., Aug. 8, 2012 (GLOBE NEWSWIRE) -- 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 second quarter and six months ended June 30, 2012 and provided an update of its hepatitis C virus (HCV) development programs.

Operational Highlights

IDX184, an HCV nucleotide polymerase inhibitor

  • The Company reported interim data in June for the first cohort of 31 patients from an ongoing phase IIb clinical trial of IDX184 in combination with pegylated interferon and ribavirin (PegIFN/RBV). Of the patients who achieved an extended rapid virologic response (undetectable levels of virus at 4 weeks and 12 weeks) and completed an additional 12 weeks of PegIFN/RBV (n=9), 100% of patients (4/4) in the 100 mg arm and 80% of patients (4/5) in the 50 mg arm achieved a sustained virologic response four weeks after the completion of treatment (SVR4).
  • Recently an independent data safety monitoring board reviewed the safety data for this study and confirmed that the side effect profile of IDX184 combined with PegIFN/RBV is consistent with that of PegIFN/RBV alone.

IDX719, an HCV NS5A inhibitor

  • IDX719 demonstrated pan-genotypic activity in a recent proof-of-concept clinical trial in genotypes 1- 4, treatment-naive HCV patients, as reported in June. After administration of 100 mg IDX719 once daily for three days, mean maximal viral load reductions were > 3.4 log10 in genotype 1, 3 and 4 HCV-infected patients. There was greater variability in responses among genotype 2 HCV-infected patients, who had mean maximal viral load reductions of 2.0 log10. As previously announced, the Company is conducting pharmacokinetic and sequencing analyses to further characterize the results in the genotype 2 study cohort. In addition, more detailed findings from the study will be presented at the American Association for the Study of Liver Diseases (AASLD) in November 2012.
  • Idenix recently announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for IDX719. With a Fast Track designation, there is an opportunity for more frequent interactions with the FDA and the possibility of a priority review, which would reduce the length of the standard FDA review period.

IDX19368, an HCV nucleotide polymerase inhibitor

  • Idenix recently submitted an investigational new drug application (IND) for its drug candidate, IDX19368. Idenix expects to initiate clinical trials in the third quarter of 2012.

Novartis Termination and Revised Relationship Agreement

  • Idenix entered into a development and commercialization collaboration in May 2003 with Novartis Pharma AG (Novartis). In July 2012, Novartis and Idenix amended the collaboration and executed a termination and revised relationship agreement. This agreement allows Idenix increased flexibility to optimize the value of its pipeline and to be well-positioned to develop all-oral direct-acting antiviral combination treatments with potential collaborators.

Underwritten Offering

  • In August 2012, Idenix issued 25.3 million shares of its common stock pursuant to an underwritten offering and received net proceeds of approximately $190.6 million.

"In the second quarter, data from our two lead clinical programs reaffirmed the antiviral activity of IDX184 and its potential as a key component in combination HCV therapy, as well as highlighted the pan-genotypic activity of IDX719. As we continue to advance these drug candidates, we also are on track to begin our third clinical program shortly," said Ron Renaud, Idenix's President and Chief Executive Officer. "With this progress, we believe we have substantially increased the value of our pipeline in 2012, further enhancing our position as a lead innovator in new treatments for HCV."

Second Quarter and Six Months Ended 2012 Financial Results

For the second quarter ended June 30, 2012, Idenix reported total revenues of $1.4 million, compared to total revenues of $1.0 million in the second quarter of 2011. The Company reported a net loss of $25.4 million, or $0.23 per basic and diluted share, for the second quarter ended June 30, 2012, compared to a net loss of $13.9 million, or $0.15 per basic and diluted share for the second quarter ended June 30, 2011.

For the six months ended June 30, 2012, Idenix reported total revenues of $37.1 million, compared to total revenues of $5.0 million for the six months ended June 30, 2011. The Company reported a net loss of $13.9 million, or $0.13 per basic and diluted share, for the six months ended June 30, 2012, compared to a net loss of $22.1 million, or $0.27 per basic and diluted share for the six months ended June 30, 2011. The change in net loss is mainly due to additional revenue as a result of the recognition of $36.1 million of deferred revenue in the first quarter of 2012 related to the termination of the license agreement with ViiV Healthcare Company offset by an increase in research and development expenses of $20.8 million in 2012 as compared to 2011. The increase in expenses was primarily due to $14.8 million related to our phase IIb clinical trial of IDX184 and our clinical trials of IDX719 as well as $6.1 million related to preclinical costs of IDX19368 in 2012.

2012 Financial Guidance

At June 30, 2012, Idenix's cash and cash equivalents totaled $79.3 million. The Company expects that its current cash, cash equivalents and the net proceeds from the underwritten offering of $190.6 million, will be sufficient to sustain its operations through at least March 31, 2014. This guidance assumes no milestone payments, license fees, reimbursement for development programs and no financing activities.

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 patients with hepatitis C infection. 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 "expect," "plans," "anticipates," "intends," "will," and similar expressions are also intended to identify forward-looking statements, as are expressed or implied statements with respect to the Company's potential pipeline candidates, including any expressed or implied statements regarding the efficacy and safety of IDX184, IDX719, IDX19368 or any other drug candidate; the successful development of novel combinations of direct-acting antivirals for the treatment of HCV; the likelihood and success of any future clinical trials involving IDX184, IDX719, IDX19368 or our other drug candidates; and expectations with respect to funding of operations and future cash balances. 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 the following: there can be no guarantees 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 expectations regarding the benefits of the restructuring of its collaboration with Novartis; 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 annual report on Form 10-K for the year ended December 31, 2011 and the quarterly report on Form 10-Q for the quarter ended March 31, 2012, each as filed with the Securities and Exchange Commission (SEC) and in any subsequent periodic or current report 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 AND COMPREHENSIVE LOSS
         
(IN THOUSANDS, EXCEPT PER SHARE DATA)
         
(UNAUDITED)
         
  Three Months Ended
June 30,
Six Months Ended
June 30,
  2012 2011 2012 2011
Revenues:        
Collaboration revenue – related party $1,438 $388 $1,015 $3,733
Other revenue   ----  656 36,068 1,312
Total revenues  1,438 1,044 37,083 5,045
Operating expenses (1):        
Cost of revenues 623 590 1,793 1,136
Research and development 20,542 10,257 39,135 18,339
General and administrative  5,861 4,480 10,635 8,394
Total operating expenses  27,026 15,327 51,563 27,869
Loss from operations (25,588) (14,283) (14,480) (22,824)
Other income, net  193 374 536 680
Loss before income taxes  (25,395) (13,909) (13,944) (22,144)
Income tax expense  ---- ---- (1) (1)
Net loss   $ (25,395)  $ (13,909)  $ (13,945)  $ (22,145)
         
Basic and diluted net loss per share:   $ (0.23)  $ (0.15)  $ (0.13)  $ (0.27)
         
Shares used in computing basic and diluted net loss per share:  108,372 92,737 108,061 82,982
         
Comprehensive loss:        
Net loss  $ (25,395)  $ (13,909)  $ (13,945)  $ (22,145)
Changes in other comprehensive income:        
Foreign currency translation adjustment (460) 115 (252) 393
Comprehensive loss  $ (25,855)  $ (13,794)  $ (14,197)  $ (21,752)
(1) Share-based compensation expenses included in operating expenses amounted to approximately:    
 Research and development $484 $280 $783 $551
 General and administrative 703 352 1,135 678
     
     
IDENIX PHARMACEUTICALS, INC.
     
CONDENSED CONSOLIDATED BALANCE SHEETS 
     
(IN THOUSANDS) 
     
(UNAUDITED) 
     
     
  June 30,
2012
December 31,
2011
     
ASSETS    
Cash and cash equivalents $79,309 $118,271
Receivables from related party 1,300 1,157
Other current assets 2,579 4,410
 Total current assets 83,188 123,838
Intangible asset, net 8,140 8,708
Property and equipment, net 4,088 4,696
Other assets 4,423 3,802
 Total assets $99,839 $141,044
     
LIABILITIES AND STOCKHOLDERS' EQUITY    
Accounts payable and accrued expenses $12,505 $11,299
Deferred revenue, related party 2,772 2,897
Other current liabilities 536 36,329
 Total current liabilities 15,813 50,525
Other long-term obligations 14,476 14,912
Deferred revenue, related party, net of current portion 21,947 24,382
 Total liabilities 52,236 89,819
Stockholders' equity 47,603 51,225
 Total liabilities and stockholders' equity $99,839 $141,044
CONTACT: Idenix Pharmaceuticals Contacts:
         Kelly Barry (617) 995-9033 (media)
         Daniella Beckman (617) 224-4471 (investors)
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