Exhibit 99.1
For Immediate Release
Contact:
Idenix Pharmaceuticals, Inc.
Media: Teri Dahlman (617) 995-9905
Investors: Amy Sullivan (617) 995-9838
IDENIX PHARMACEUTICALS ANNOUNCES THIRD QUARTER AND NINE MONTH FINANCIAL RESULTS
Cambridge, MA; November 02, 2004- Idenix Pharmaceuticals, Inc. (NASDAQ: IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral and other infectious diseases, today reported financial results for the third quarter and nine months ended September 30, 2004. For the third quarter ended September 30, 2004, Idenix reported total revenues of $17.2 million, compared with total revenues of $12.7 million in the third quarter of 2003. Total revenues include reimbursements by Novartis Pharma AG of the expenses incurred by Idenix in connection with the development of telbivudine and valtorcitabine, Idenix’s drug candidates for the treatment of hepatitis B, and amortization of the up-front fee received when Novartis licensed the company’s hepatitis B drug candidates in May 2003. Idenix reported a net loss of approximately $7.4 million, or a loss of $0.17 per diluted share for the third quarter ended September 30, 2004, compared to a net loss of approximately $1.4 million, or $0.04 per diluted share for the third quarter ended September 30, 2003.
For the nine months ended September 30, 2004, Idenix reported total revenues of approximately $76.6 million, compared with total revenues of approximately $16.0 million for the nine months ended September 30, 2003. Idenix reported net income of approximately $7.7 million, or $0.19 per diluted share for the nine months ended September 30, 2004, compared to a net loss attributable to common stockholders of approximately $63.7 million, or $2.79 per diluted share for the nine months ended September 30, 2003. The company’s profitability for the nine months ended September 30, 2004 was due to the recognition of a $25 million cash milestone payment by Novartis, which the company received in June 2004. The milestone was attributable to the results obtained by Idenix in a phase I clinical trial of NM 283, Idenix’s lead drug candidate for the treatment of hepatitis C. The company does not expect to sustain near-term profitability.
At September 30, 2004, Idenix’s cash and cash equivalents and marketable securities totaled approximately $174 million.
“Since the end of the second quarter, we have realized several significant accomplishments,” said Jean-Pierre Sommadossi, chairman and chief executive officer of Idenix. “We have advanced our programs for the treatment of hepatitis B virus (HBV) and hepatitis C virus (HCV), completed our initial public offering, and, after the quarter closed, presented positive final data from the phase I clinical trial of NM 283, our lead HCV drug candidate, and positive interim data from our phase IIa clinical trial of NM 283. We are on track to initiate phase IIb clinical trials for NM 283 and a combination trial of valtorcitabine and telbivudine before year end.”
Business Highlights
The accomplishments achieved by Idenix subsequent to June 30, 2004 include:
| • | Completion of an initial public offering and concurrent private placement to Novartis raising approximately $132.6 million in proceeds, net of underwriting discounts and offering expenses, in July 2004. | |||
| • | Achievement of a 2004 corporate milestone with the filing of an investigational new drug application for NM 107, the active molecule into which NM 283 is converted in the body, for the treatment of hepatitis C in liver transplant patients, in October 2004. | |||
| • | Presentation of final results of the phase I dose escalation clinical trial of NM 283, a novel once-daily oral treatment for hepatitis C, at the annual meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston on November 1, 2004. Patients in the final dosing cohort of 800 mg/day achieved a mean viral load reduction of 94 percent in a 15-day treatment period. | |||
| • | Presentation of interim results of the ongoing phase IIa clinical trial of NM 283 in combination with pegylated-interferon for 19 patients at week 4 were also announced at AASLD. This interim data is from an ongoing clinical trial evaluating the safety, antiviral activity and pharmacokinetics of the combination treatment of NM 283 and pegylated interferon. Data presented at the conference demonstrate that those patients receiving the combination of NM 283 plus pegylated interferon exhibited a consistent and rapid reduction in levels of HCV in the blood serum evidencing marked antiviral activity. | |||
Additional details regarding the company’s recent data presentations can be found in press releases issued by the company on November 1, 2004.
The company also announced today that David Shlaes, M.D., Ph.D., will resign as an executive officer of the company and become a senior fellow at Idenix. In this role, Dr. Shlaes will continue to assist the company in the conduct of its preclinical activities and with the completion of nonclinical studies required for the anticipated regulatory filings with regard to the company’s drug development programs.
Conference Call Information
Idenix will hold a conference call today at 4:30 p.m. eastern time. Company management will review the financial results, as well as provide a review of recently presented data and an update on corporate milestones. The call will be available on the company’s website www.idenix.com. Please log in approximately 10 minutes before the call to ensure a timely connection.
About Idenix
Idenix Pharmaceuticals, Inc. (NASDAQ: IDIX) is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral and other infectious diseases. Idenix’s current focus is on the treatment of infections caused by hepatitis B virus, hepatitis C virus and human immunodeficiency virus (HIV). Idenix’s headquarters are located in Cambridge, Massachusetts and it has drug discovery operations in Montpellier, France and Cagliari, Italy. For further information about Idenix, please refer to http://www.idenix.com.
Forward-looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Act of 1995. Statements in this press release other than those that are historical in nature are “forward-looking statements.” Such forward looking statements, which include statements with
respect to the potential therapeutic benefits and successful development of the company’s drug candidates and the company’s drug discovery, research and clinical development, regulatory approval processes and commercialization activities, are subject to numerous factors, risks and uncertainties that may cause actual events or results to differ materially from the company’s current expectations. These risks and uncertainties relate to the results of clinical trials and other studies with respect to the drug candidates that the company has under development; the timing and success of submission, acceptance and approval of regulatory filings; the company’s dependence on its collaboration with Novartis Pharma AG; the company’s ability to obtain additional funding required to conduct its research, development and commercialization activities; the ability of the company to attract and retain qualified personnel; and the company’s ability to obtain, maintain and enforce patent and other intellectual property protection for its drug candidates and its discoveries. These and other risks are described in greater detail in the “Risk Factors” section of the company’s quarterly report on Form 10-Q for the quarter ended June 30, 2004 and filed with the Securities and Exchange Commission and other filings that the company makes with the Securities and Exchange Commission.
All forward-looking statements reflect the company’s expectations only as of the date of this release 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. Idenix anticipates that subsequent events and developments may cause these views, expectations and beliefs to change. However, while Idenix may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so.
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IDENIX PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT SHARE DATA)
(UNAUDITED)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2004 | 2003 | 2004 | 2003 | |||||||||||||
| Revenues: | ||||||||||||||||
| License fees and collaborative research and development — related party | $ | 17,052 | $ | 12,585 | $ | 76,371 | $ | 19,863 | ||||||||
| License fees and collaborative research and development — other | — | — | — | (4,165 | ) | |||||||||||
| Government research grants | 127 | 96 | 259 | 308 | ||||||||||||
| Total revenues | 17,179 | 12,681 | 76,630 | 16,006 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 19,048 | 11,411 | 55,142 | 34,926 | ||||||||||||
| General and administrative | 4,205 | 2,211 | 10,942 | 14,720 | ||||||||||||
| Sales and marketing | 1,840 | 572 | 3,653 | 1,251 | ||||||||||||
| Total operating expenses | 25,093 | 14,194 | 69,737 | 50,897 | ||||||||||||
| Income (loss) from operations | (7,914 | ) | (1,513 | ) | 6,893 | (34,891 | ) | |||||||||
| Investment income, net | 521 | 139 | 665 | 308 | ||||||||||||
| Other income (expense) | 1 | 1 | (1 | ) | (14 | ) | ||||||||||
| Income (loss) before income taxes | (7,392 | ) | (1,373 | ) | 7,557 | (34,597 | ) | |||||||||
| Income tax benefit | 39 | — | 153 | — | ||||||||||||
| Net income (loss) | (7,353 | ) | (1,373 | ) | 7,710 | (34,597 | ) | |||||||||
| Accretion of redeemable convertible preferred stock | — | — | — | (29,074 | ) | |||||||||||
| Net income (loss) attributable to common stockholders | ($7,353 | ) | ($1,373 | ) | $ | 7,710 | ($63,671 | ) | ||||||||
| Net income (loss) per share: | ||||||||||||||||
| Basic | ($0.17 | ) | ($0.04 | ) | $ | 0.20 | ($2.79 | ) | ||||||||
| Diluted | ($0.17 | ) | ($0.04 | ) | $ | 0.19 | ($2.79 | ) | ||||||||
| Shares used in calculation of net income (loss) per share: | ||||||||||||||||
| Basic | 44,520 | 36,424 | 39,190 | 22,789 | ||||||||||||
| Diluted | 44,520 | 36,424 | 41,361 | 22,789 | ||||||||||||
IDENIX PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS)
(UNAUDITED)
| September 30, | December 31, | |||||||
| 2004 | 2003 | |||||||
| ASSETS | ||||||||
| Cash and cash equivalents | $ | 131,535 | $ | 43,485 | ||||
| Marketable securities | 19,858 | — | ||||||
| Accounts receivable, related party | 14,202 | 11,152 | ||||||
| Other current assets | 4,840 | 5,717 | ||||||
| Total current assets | 170,435 | 60,354 | ||||||
| Property and equipment, net | 6,024 | 4,066 | ||||||
| Marketable securities, non-current | 22,856 | — | ||||||
| Other assets | 2,515 | 2,670 | ||||||
| Total assets | $ | 201,830 | $ | 67,090 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | ||||||||
| Accounts payable and accrued expenses | $ | 18,515 | $ | 18,535 | ||||
| Deferred revenue, related party | 9,700 | 10,756 | ||||||
| Other current liabilities | 448 | 664 | ||||||
| Total current liabilities | 28,663 | 29,955 | ||||||
| Long-term obligations | 9,393 | 10,627 | ||||||
| Deferred revenue, related party, net of current portion | 41,226 | 54,239 | ||||||
| Total liabilities | 79,282 | 94,821 | ||||||
| Stockholders’ equity (deficit) | 122,548 | (27,731 | ) | |||||
| Total liabilities and stockholders’ equity (deficit) | $ | 201,830 | $ | 67,090 | ||||