CAMBRIDGE, Mass., Feb. 25, 2013 (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 fourth quarter and year ended December 31, 2012.
HCV Pipeline and Business Review
IDX719, NS5A Inhibitor Program
- In January 2013, Idenix entered into a non-exclusive collaboration with Janssen Pharmaceuticals, Inc. for the clinical development of all-oral direct-acting antiviral (DAA) HCV combination therapies. The collaboration will evaluate combinations including IDX719, Idenix's once-daily pan-genotypic NS5A inhibitor, simeprevir (TMC435), a once-daily protease inhibitor jointly developed by Janssen and Medivir AB, and TMC647055, a once-daily non-nucleoside polymerase inhibitor, boosted with low dose ritonavir, being developed by Janssen. Clinical development plans include an initial drug-drug interaction study to begin in the first quarter of 2013, followed by phase II studies as agreed between the companies and pending approval from regulatory authorities.
Nucleotide Inhibitor Program
- The Company expects to file an investigational new drug application (IND) for a lead uridine-based nucleotide analog candidate from its next-generation nucleotide prodrug discovery program in the first half of 2013. The Company also expects to conduct IND-enabling studies for additional nucleotide prodrugs in 2013.
- In February 2013, Idenix elected to discontinue the development of IDX184 and IDX19368, the Company's guanosine-based nucleotide prodrug programs, after the U.S. Food and Drug Administration (FDA) communicated that the programs would remain on a clinical hold that began in August 2012 due to cardiac adverse events seen in a competitor's phase II clinical trial of BMS-986094.
"In 2013, one of our primary goals is to generate IDX719 data in all-oral combination therapies, initially through collaborations beginning in the first half of the year, and subsequently with our own nucleotide prodrug by year end. Also, we have an intensive, rapidly accelerating nucleotide discovery effort and are on track to file one IND from this program in the first half of 2013 and at least one additional IND by the end of the year," said Ron Renaud, Idenix's President and Chief Executive Officer. "With promising candidates from two HCV classes advancing in the clinic by the end of the year, we believe we will be in a good position to evaluate multiple all-oral combination therapies for HCV."
Fourth Quarter and Year Ended 2012 Financial Results
For the fourth quarter ended December 31, 2012, Idenix reported total revenues of $0.3 million, compared to total revenues of ($0.7) million in the fourth quarter of 2011. The Company reported a net loss of $22.7 million, or $0.17 per basic and diluted share, for the fourth quarter ended December 31, 2012, compared to a net loss of $18.1 million, or $0.18 per basic and diluted share for the fourth quarter ended December 31, 2011.
For the year ended December 31, 2012, Idenix reported total revenues of $69.7 million, compared to total revenues of $7.0 million for the year ended December 31, 2011. The Company reported a net loss of $32.4 million, or $0.27 per basic and diluted share, for the year ended December 31, 2012, compared to a net loss of $52.0 million, or $0.57 per basic and diluted share for the year ended December 31, 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 and $27.1 million of additional revenue recognized in the third quarter of 2012 as a result of the restructuring of our collaboration with Novartis Pharma AG in July 2012. These amounts were offset by increases in research and development expenses of $28.8 million related primarily to IDX184 and IDX719, professional and legal costs of $7.1 million and an $8.0 million intangible asset impairment charge in the third quarter of 2012 related to the termination agreement with Novartis.
2013 Financial Guidance
At December 31, 2012, Idenix's cash and cash equivalents totaled $230.8 million. The Company expects that its current cash and cash equivalents will be sufficient to sustain its operations into at least the second half of 2014. This guidance assumes no milestone payments, license fees, reimbursement for development programs and no financing activities.
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.
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 IDX719 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 IDX719 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 September 30, 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)|
| Three Months Ended |
| Years Ended |
|Collaboration revenue – related party||$ 327||$ (1,387)||$ 33,595||$ 4,328|
|Operating expenses (1):|
|Cost of revenues||352||593||2,654||2,324|
|Research and development||17,578||12,811||70,182||41,341|
|General and administrative||7,364||4,399||24,163||16,694|
|Intangible asset impairment||-----||-----||8,045||-----|
|Total operating expenses||25,294||17,803||105,044||60,359|
|Loss from operations||(24,967)||(18,535)||(35,381)||(53,408)|
|Other income, net||2,152||348||2,892||1,368|
|Loss before income taxes||(22,815)||(18,187)||(32,489)||(52,040)|
|Income tax benefit||90||62||89||61|
|Net loss||$ (22,725)||$ (18,125)||$ (32,400)||$ (51,979)|
|Basic and diluted net loss per share||($ 0.17)||($ 0.18)||($ 0.27)||($ 0.57)|
|Shares used in calculation of basic and diluted net loss per share||133,897||100,973||118,755||90,831|
|Net loss||$ (22,725)||$ (18,125)||$ (32,400)||$ (51,979)|
|Changes in other comprehensive income:|
|Foreign currency translation adjustment||194||(325)||105||(318)|
|Comprehensive loss||$ (22,531)||$ (18,450)||$ (32,295)||$ (52,297)|
|(1) Share-based compensation expenses included in operating expenses amounted to approximately:|
|Research and development||$ 533||$ 246||$ 1,810||$ 1,066|
|General and administrative||1,150||335||3,026||1,357|
|IDENIX PHARMACEUTICALS, INC.|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|December 31, 2012||December 31, 2011|
|Cash and cash equivalents||$ 230,826||$ 118,271|
|Receivables from related party||1,195||1,157|
|Other current assets||5,771||4,410|
|Total current assets||237,792||123,838|
|Intangible asset, net||-----||8,708|
|Property and equipment, net||3,274||4,696|
|Receivables from related party, net of current portion||6,210||-----|
|Total assets||$ 250,865||$ 141,044|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accounts payable and accrued expenses||$ 15,064||$ 11,299|
|Deferred revenue, related party||714||2,897|
|Other current liabilities||154||36,329|
|Total current liabilities||15,932||50,525|
|Other long-term obligations||11,785||14,912|
|Deferred revenue, related party, net of current portion||3,988||24,382|
|Total liabilities and stockholders' equity||$ 250,865||$ 141,044|
CONTACT: Idenix Pharmaceuticals Contacts: Kelly Barry (617) 995-9033 (media) Teri Dahlman (617) 995-9807 (investors)Source:Idenix Pharmaceuticals