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8-K - FORM 8-K - IDENIX PHARMACEUTICALS INC | c13321e8vk.htm |
Exhibit 99.1
FOR IMMEDIATE RELEASE
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 REPORTS FOURTH QUARTER AND YEAR END 2010 FINANCIAL RESULTS
Cambridge, Mass., Feb. 28, 2011 - 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, 2010. At December 31, 2010, Idenixs cash and cash equivalents totaled $46.1
million.
Business Highlights
| IDX184 Update | ||
In February 2011, the U.S. Food and Drug Administration (FDA) removed the full clinical hold for IDX184. The program was placed on partial clinical hold, which allows Idenix to resume clinical trials involving IDX184 immediately. Idenix plans to initiate a Phase IIb 12-week clinical trial of IDX184 in combination with pegylated interferon and ribavirin in the second half of 2011. Under the partial clinical hold, Idenix will share interim data from the Phase IIb study with the FDA. | |||
| IDX375, an HCV Non-Nucleoside Polymerase Inhibitor | ||
In the first quarter of 2011, Idenix completed a three-day proof-of-concept study of IDX375 in treatment-naïve genotype 1-infected patients. Mean viral load reductions after three days of IDX375 monotherapy were 1.3, 2.3, and 2.7 log10 IU/mL at doses of 100, 200, and 400 mg BID, respectively. Overall, IDX375 was generally safe and well-tolerated at the three doses tested. | |||
| HCV NS5A Inhibitor Program | ||
Idenix is developing NS5A compounds with pan-genotypic activity. Two drug candidates have been selected for preclinical development, and Idenix plans to file an Investigational New Drug (IND) application or Clinical Trial Application (CTA) for one of these candidates in 2011. | |||
| HCV Protease Inhibitor Follow-On Program | ||
Idenix has discontinued further development of IDX320 following its conclusion that IDX320 likely caused the observed toxicity in the drug-drug interaction (DDI) study with IDX184. Idenix has follow-on drug candidates in the protease inhibitor class that are currently in preclinical development. Idenix anticipates selecting a clinical candidate with broad genotypic activity in 2011. | |||
| HCV Nucleoside/tides and Prodrugs | ||
Idenix is committed to an intensive and renewed strategy in the discovery and development of nucleoside/tides, with potential application against HCV and other infectious diseases. Currently, Idenix is pursuing multiple follow-on and novel nucleoside/tide programs. |
| GSK2248761, known as 761 (formerly IDX899), an HIV NNRTI | ||
In February 2011, Idenix was informed by ViiV Healthcare Company (ViiV) that 761 was placed on clinical hold by the FDA. ViiV has full responsibility for the development of 761, including any regulatory interactions. |
We are very pleased that the FDA has allowed IDX184, our lead HCV nucleoside inhibitor drug
candidate, to advance directly into clinical trials, said Ron Renaud, President and CEO. We
gained insights about our most advanced clinical drug candidates as we prepared our response to the
FDA clinical hold, and can apply this knowledge to ongoing preclinical programs. We are excited
about our renewed focus on our nucleoside capabilities, as well as multiple opportunities to
develop diverse direct-acting antiviral drug candidate classes for HCV.
Fourth Quarter and Full Year 2010 Financial Results
For the fourth quarter ended December 31, 2010, Idenix reported total revenues of $2.4 million,
compared to total revenues of $3.0 million in the fourth quarter of 2009. The company reported a
net loss of $16.2 million, or a loss of $0.22 per basic and diluted share, for the fourth quarter
ended December 31, 2010, compared to 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.
For the twelve months ended December 31, 2010, Idenix reported total revenues of $10.2 million,
compared to total revenues of $12.6 million for the twelve months ended December 31, 2009. The
company reported a net loss of $61.6 million, or a loss of $0.87 per basic and diluted share, for
the twelve months ended December 31, 2010, compared to 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.
2011 Financial Guidance
The company expects that its current cash and cash equivalents, the anticipated royalty payments
associated with product sales of Tyzeka®/Sebivo® (telbivudine) and its ability and intent to manage
expenditures will be sufficient to satisfy its cash needs for at least the next 12 months. This
guidance assumes no additional 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. 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 44647149. 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 14, 2011. To
access the replay, please dial (800) 642-1687 U.S./Canada or (706) 645-9291 International and enter
the passcode 44647149.
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, 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 our drug candidates, the
likelihood and success of any future clinical trials involving our drug candidates. 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 each
of the companys annual report on Form 10-K for the year ended December 31, 2009 and quarterly
report on form 10-Q for the quarter ended September 30, 2010, 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, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT PER SHARE DATA)
(UNAUDITED)
Three Months Ended | Years Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
2010 | 2009 | 2010 | 2009 | |||||||||||||
Revenues: |
||||||||||||||||
Collaboration revenue related party |
$ | (135 | ) | $ | 2,780 | $ | 6,231 | $ | 11,717 | |||||||
Other revenue |
2,570 | 269 | 3,991 | 899 | ||||||||||||
Total revenues |
2,435 | 3,049 | 10,222 | 12,616 | ||||||||||||
Operating expenses (1): |
||||||||||||||||
Cost of revenues |
965 | 710 | 2,765 | 2,210 | ||||||||||||
Research and development |
8,958 | 10,268 | 44,506 | 41,867 | ||||||||||||
General and administrative |
9,132 | 4,889 | 23,439 | 21,467 | ||||||||||||
Restructuring charges |
| | 2,238 | 1,506 | ||||||||||||
Total operating expenses |
19,055 | 15,867 | 72,948 | 67,050 | ||||||||||||
Loss from operations |
(16,620 | ) | (12,818 | ) | (62,726 | ) | (54,434 | ) | ||||||||
Other income, net |
419 | 475 | 1,131 | 1,266 | ||||||||||||
Loss before income taxes |
(16,201 | ) | (12,343 | ) | (61,595 | ) | (53,168 | ) | ||||||||
Income tax benefit (expense) |
44 | 31 | 40 | (51 | ) | |||||||||||
Net loss |
$ | (16,157 | ) | $ | (12,312 | ) | $ | (61,555 | ) | $ | (53,219 | ) | ||||
Basic and diluted net loss per share: |
($0.22 | ) | ($0.19 | ) | ($0.87 | ) | ($0.87 | ) | ||||||||
Shares used in calculation of basic and
diluted net loss per share: |
73,011 | 66,357 | 70,715 | 61,498 | ||||||||||||
(1) | Share-based compensation expenses included in operating expenses amounted to approximately: |
Research and development |
$ | 272 | $ | 336 | $ | 1,214 | $ | 1,546 | ||||||||
General and administrative |
3,253 | 724 | 5,203 | 3,068 |
IDENIX PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS)
(UNAUDITED)
December 31, | December 31, | |||||||
2010 | 2009 | |||||||
ASSETS |
||||||||
Cash and cash equivalents |
$ | 46,115 | $ | 46,519 | ||||
Receivables from related party |
840 | 1,049 | ||||||
Other current assets |
2,535 | 4,012 | ||||||
Total current assets |
49,490 | 51,580 | ||||||
Intangible asset, net |
9,843 | 11,069 | ||||||
Property and equipment, net |
7,179 | 10,091 | ||||||
Marketable securities |
| 1,584 | ||||||
Other assets |
3,372 | 2,326 | ||||||
Total assets |
$ | 69,884 | $ | 76,650 | ||||
LIABILITIES AND STOCKHOLDERS DEFICIT |
||||||||
Accounts payable and accrued expenses |
$ | 14,030 | $ | 10,720 | ||||
Deferred revenue, related party |
3,036 | 6,155 | ||||||
Other current liabilities |
2,928 | 1,469 | ||||||
Total current liabilities |
19,994 | 18,344 | ||||||
Other long-term liabilities |
52,398 | 32,983 | ||||||
Deferred revenue, related party, net of current portion |
28,588 | 30,776 | ||||||
Total liabilities |
100,980 | 82,103 | ||||||
Stockholders deficit |
(31,096 | ) | (5,453 | ) | ||||
Total liabilities and stockholders deficit |
$ | 69,884 | $ | 76,650 | ||||