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8-K - FORM 8-K - IDENIX PHARMACEUTICALS INC | c20965e8vk.htm |
Exhibit 99.1
IDENIX PHARMACEUTICALS REPORTS SECOND QUARTER AND SIX MONTH
2011 FINANCIAL RESULTS AND PROVIDES PIPELINE UPDATE
2011 FINANCIAL RESULTS AND PROVIDES PIPELINE UPDATE
Cambridge, Mass., August 8, 2011 -
| Lead nucleotide polymerase inhibitor IDX184 advancing clinically The Company has initiated dosing of IDX184 in combination with pegylated interferon and ribavirin (Peg-IFN/RBV) in a Phase IIb hepatitis C virus (HCV) trial | ||
| HCV pipeline progressing The Company has selected IDX719 as lead NS5A candidate, has identified IDX077 and IDX791 as two potential PI preclinical candidates, and is presently focused on generating and selecting promising novel nucleotide prodrug inhibitors |
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, 2011. At June 30, 2011, Idenixs cash and cash equivalents totaled $78.4
million.
Ron Renaud, President and Chief Executive Officer, stated, Over the last nine months, we have made
significant progress in our product development pipeline. We are very pleased to have advanced
IDX184, our lead novel nucleoside polymerase inhibitor, into a Phase IIb clinical study for
patients with HCV infection. We anticipate reporting interim data from this study in the fourth
quarter of 2011.
Mr. Renaud continued, In addition to IDX184, we are excited about the significant progress we have
made in our pipeline of novel nucleotide polymerase inhibitors. By leveraging Idenixs scientific
expertise in this area, we have been able to generate many interesting and innovative preclinical
HCV nucleotide prodrugs. We continue to believe this therapeutic class has the potential to become
the backbone of the evolving HCV treatment paradigm. In addition, our lead NS5A inhibitor (IDX719)
is currently in IND-enabling studies and we are looking forward to a year-end regulatory filing.
Second Quarter and Six Month 2011 Financial Results
For the second quarter ended June 30, 2011, Idenix reported total revenues of $1.0 million,
compared to total revenues of $1.3 million in the second quarter of 2010. The Company reported a
net loss of $13.9 million, or a loss of $0.15 per basic and diluted share, for the second quarter
ended June 30, 2011, compared to a net loss of $16.3 million, or a loss of $0.23 per basic and
diluted share for the second quarter ended June 30, 2010.
For the six months ended June 30, 2011, Idenix reported total revenues of $5.0 million, compared to
total revenues of $4.0 million in the six months ended June 30, 2010. The Company reported a net
loss of $22.1 million, or a loss of $0.27 per basic and diluted share, for the six months ended
June 30, 2011, compared to a net loss of $32.5 million, or a loss of $0.47 per basic and diluted
share for the six months ended June 30, 2010. The $10.4 million reduction in net loss in 2011 was
due primarily to lower expenses associated with the Companys HCV drug candidates, IDX184 and
IDX320, and non-recurring restructuring expenses in 2010. During the first half of 2010, the
Company was conducting a Phase IIa clinical trial for IDX184 and clinical trials for IDX320,
whereas there were no ongoing trials for either drug candidate in the six months ended June 30,
2011. The Company expects expenses to increase during the second half of 2011 as a result of the
initiation of a Phase IIb clinical trial for IDX184 in July 2011.
2011 Financial Guidance
The Company expects that its current cash, cash equivalents and the anticipated royalty payments
associated with product sales of Tyzeka®/Sebivo® (telbivudine) will be sufficient to satisfy its
cash needs until at least the second quarter of 2012. This guidance assumes no additional milestone
payments, license fees, reimbursement for development programs and no financing activities.
Operational Highlights
IDX184 Program
IDX184, Idenixs lead pipeline candidate, is an investigational oral guanosine nucleotide
polymerase inhibitor for the treatment of HCV that has demonstrated antiviral activity in both
preclinical and clinical development.
In July 2011, the Company initiated enrollment of 100 HCV-infected patients into a 12-week Phase
IIb trial of IDX184 in combination with pegylated interferon and ribavirin, and has begun dosing
patients in this study. The Company anticipates releasing interim one month safety and antiviral
activity data on the first 30 patients from the Phase IIb trial in the fourth quarter of 2011.
Novel Nucleotide Prodrug Program
Idenix has identified and is advancing in preclinical development additional highly potent
nucleotide polymerase inhibitors, including both purine and pyrimidine compounds. As part of this
effort, the Company is also pursuing several innovative prodrug approaches to preferentially
deliver these agents to the liver.
NS5A Program
Idenix has selected IDX719 as the lead candidate for its NS5A program. In preclinical studies,
IDX719 has shown potent activity and broad genotypic coverage. Studies to enable an
Investigational New Drug (IND) application remain on track, and the Company expects to submit
regulatory filings by year-end 2011 and begin the clinical program in early 2012.
Protease Inhibitor (PI) Program
Idenix has identified two potential PI candidates, IDX077 and IDX791, with broad genotypic
activity. The Company expects to continue preclinical work in 2011, which could result in the
selection of a lead candidate by year-end 2011.
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. Idenixs current focus is on the treatment of patients with chronic hepatitis C
infection. For further information about Idenix, please refer to www.idenix.com.
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 86055177. A slide
presentation will accompany the conference call and can be accessed on the Investor section of the
Idenix website at www.idenix.com. Please log on approximately 10 minutes prior to the
start of the call to ensure adequate time for any downloads that may be necessary.
A replay of the conference call and webcast will be available until August 22, 2011, by dialing
800-642-1687 (U.S./Canada) or 706-645-9291 (International) and enter the passcode 86055177.
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 Companys 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 Companys
potential pipeline candidates, including any expressed or implied statements regarding the efficacy
and safety of IDX184 or any other drug candidate; the successful development of novel combinations
of direct-acting antivirals for the treatment of hepatitis C; the likelihood and success of any
future clinical trials involving our drug candidates; and expectations with respect to additional
milestone payments, future royalty payments, 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; managements
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 Companys ability to obtain additional
funding required to conduct its research, development and commercialization activities; the
Companys dependence on its collaborations with Novartis Pharma AG and GlaxoSmithKline/ViiV
Healthcare; changes in the Companys business plan or objectives; the ability of the Company to
attract and retain qualified personnel; competition in general; and the Companys 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 managements expectations are described in greater detail under the
heading Risk Factors in the Companys annual report on Form 10-K for the year ended December 31,
2010 and the quarterly report on Form 10-Q for the quarter ended March 31, 2011, 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 Companys estimates only as of the date of this release
(unless another date is indicated) and should not be relied upon as reflecting the Companys 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 Companys estimates change.
Idenix Pharmaceuticals Contacts:
Kelly Barry (617) 995-9033 (media)
Eric Hoffman (617) 224-4485 (investors)
Kelly Barry (617) 995-9033 (media)
Eric Hoffman (617) 224-4485 (investors)
IDENIX PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT PER SHARE DATA)
(UNAUDITED)
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
Revenues: |
||||||||||||||||
Collaboration revenue related party |
$ | 388 | $ | 527 | $ | 3,733 | $ | 2,943 | ||||||||
Other revenue |
656 | 789 | 1,312 | 1,056 | ||||||||||||
Total revenues |
1,044 | 1,316 | 5,045 | 3,999 | ||||||||||||
Operating expenses (1): |
||||||||||||||||
Cost of revenues |
590 | 675 | 1,136 | 1,234 | ||||||||||||
Research and development |
10,257 | 12,149 | 18,339 | 23,911 | ||||||||||||
General and administrative |
4,480 | 5,091 | 8,394 | 9,868 | ||||||||||||
Restructuring charges |
| | | 2,238 | ||||||||||||
Total operating expenses |
15,327 | 17,915 | 27,869 | 37,251 | ||||||||||||
Loss from operations |
(14,283 | ) | (16,599 | ) | (22,824 | ) | (33,252 | ) | ||||||||
Other income, net |
374 | 347 | 680 | 788 | ||||||||||||
Loss before income taxes |
(13,909 | ) | (16,252 | ) | (22,144 | ) | (32,464 | ) | ||||||||
Income tax expense |
| (4 | ) | (1 | ) | (5 | ) | |||||||||
Net loss |
$ | (13,909 | ) | $ | (16,256 | ) | $ | (22,145 | ) | $ | (32,469 | ) | ||||
Basic and diluted net loss per share: |
($0.15 | ) | ($0.23 | ) | ($0.27 | ) | ($0.47 | ) | ||||||||
Shares used in calculation of basic and diluted net
loss per share: |
92,737 | 70,446 | 82,982 | 68,419 | ||||||||||||
(1) Share-based compensation expenses included in
operating expenses amounted to approximately: |
||||||||||||||||
Research and development |
$ | 280 | $ | 314 | $ | 551 | $ | 634 | ||||||||
General and administrative |
352 | 643 | 678 | 1,304 |
IDENIX PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS)
(UNAUDITED)
June 30, | December 31, | |||||||
2011 | 2010 | |||||||
ASSETS |
||||||||
Cash and cash equivalents |
$ | 78,353 | $ | 46,115 | ||||
Receivables from related party |
1,170 | 840 | ||||||
Other current assets |
3,138 | 2,535 | ||||||
Total current assets |
82,661 | 49,490 | ||||||
Intangible asset, net |
9,275 | 9,843 | ||||||
Property and equipment, net |
6,072 | 7,179 | ||||||
Other assets |
4,272 | 3,372 | ||||||
Total assets |
$ | 102,280 | $ | 69,884 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY (DEFICIT) |
||||||||
Accounts payable and accrued expenses |
$ | 9,460 | $ | 14,030 | ||||
Deferred revenue, related party |
3,037 | 3,036 | ||||||
Other current liabilities |
3,053 | 2,928 | ||||||
Total current liabilities |
15,550 | 19,994 | ||||||
Other long-term obligations |
50,857 | 52,398 | ||||||
Deferred revenue, related party, net of current portion |
27,079 | 28,588 | ||||||
Total liabilities |
93,486 | 100,980 | ||||||
Stockholders equity (deficit) |
8,794 | (31,096 | ) | |||||
Total liabilities and stockholders equity (deficit) |
$ | 102,280 | $ | 69,884 | ||||