
| Investor Contact: | Media Contact: |
| James T. Glover SVP, Operations & CFO Anadys Pharmaceuticals, Inc. (858) 530-3763 jglover@anadyspharma.com | Ian Stone or David Schull Russo Partners, LLC (619) 814-3510 ian.stone@russopartnersllc.com david.schull@russopartnersllc.com |
San Diego, October 23, 2008 – Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS), a clinical-stage biopharmaceutical company dedicated to improving patient care by developing novel medicines in the areas of hepatitis C and oncology, today reported its financial results and highlights for the third quarter ended September 30, 2008.
"We continue to make rapid progress in both of our hepatitis C development programs," said Steve Worland Ph.D., President and CEO of Anadys. "We completed our first clinical study of ANA598 in healthy volunteers and have now completed the healthy volunteer portion of our ongoing ANA773 study. For both programs, we are very encouraged by the data and look forward to initiating patient dosing this quarter."
As of September 30, 2008, the Company’s cash, cash equivalents and securities available-for-sale totaled $34.4 million.
During the third quarter of 2008 the Company had no revenue, compared to $21.5 million for the same quarter of 2007. The revenue in the third quarter of 2007 was primarily derived from the recognition of previously deferred revenue associated with an upfront payment and a milestone payment under a prior collaboration.
Research and development expenses were $7.6 million for the third quarter of 2008 and 2007. During the third quarter of 2008, cost savings derived from Anadys’ completed strategic restructuring and associated termination of prior development programs were offset by a significant increase in ANA598 development costs.
General and administrative expenses were $2.1 million for the third quarter of 2008, compared to $2.4 million for the third quarter of 2007. The $0.3 million decrease primarily resulted from cost savings derived from Anadys’ completed strategic restructuring.
Operating expenses were $9.7 million for the third quarter of 2008, compared to $10.0 million for the third quarter of 2007. Included as a component of Anadys’ operating expenses were non-cash, share-based expenses of $0.7 million and $1.4 million for the third quarter of 2008 and 2007, respectively.
The net loss was $9.3 million for the third quarter of 2008, compared to net income of $12.3 million for the third quarter of 2007. Basic and diluted net loss per common share was $0.32 in the third quarter of 2008, compared to net income per common share of $0.43 in the third quarter of 2007. Non-cash share-based expense resulted in a $0.03 increase in basic and diluted net loss per share for the third quarter of 2008 compared to a $0.05 decrease in basic and diluted net income per share for the third quarter 2007.
During the nine months ended September 30, 2008 the Company had no revenue, compared to $23.9 million for the same period in 2007. The revenue recognized in the first nine months of 2007 was primarily derived from the amortization of an upfront payment and a milestone payment under a prior collaboration and the recognition of the previously deferred revenue upon termination of the collaboration. Operating expenses during the nine months ended September 30, 2008 were $25.2 million compared to $28.1 million for the nine months ended September 30, 2007. The decrease in operating expenses was a result of cost savings derived from Anadys’ completed restructuring partially offset by increases in development costs for ANA598 and ANA773. For the nine months ended September 30, 2008, Anadys reported a net loss of $23.9 million, compared to $1.4 million for the same period last year. Basic and diluted net loss per common share was $0.83 for the nine months ended September 30, 2008, compared to $0.05 for the same period in 2007.
Anadys will host a conference call at 5:00 p.m. EDT today to discuss its third quarter financial results and highlights and to provide an update on its development programs. A live webcast of the call will be available online at www.anadyspharma.com. A telephone replay will also be available approximately one hour after completion of the call. To access the telephone replay, dial 888-286-8010 (domestic) or 617801-6888 (international), passcode 86226986. The webcast and telephone replay will be available through November 6, 2008.
Anadys Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company dedicated to improving patient care by developing novel medicines in the areas of hepatitis C and oncology. For the treatment of chronic hepatitis C, the Company is developing two potentially complementary agents, ANA598, a non-nucleoside polymerase inhibitor and ANA773, an oral TLR7 agonist prodrug. The Company is also developing ANA773 for the treatment of cancer.
Statements in this press release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, references to the expected timing and planned development activities for ANA598 and ANA773, including the trial design, occurrence, timing, and pace of future clinical trials, the timing for obtaining viral load data and expectations regarding such data, as well as the anticipated future clinical benefits of ANA598 and ANA773. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause Anadys' actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. For example, the results of preclinical studies and early clinical trials may not be predictive of future results, and Anadys cannot provide any assurances that ANA598 or ANA773 will not have unforeseen safety issues, will have favorable results in future clinical trials or will receive regulatory approval. In addition, Anadys' results may be affected by competition from other biotechnology and pharmaceutical companies, its effectiveness at managing its financial resources, its ability to enter into collaborations around its product candidates, its ability to successfully develop and market products, difficulties or delays in its preclinical studies or clinical trials, difficulties or delays in manufacturing its clinical trials materials, the scope and validity of patent protection for its products, regulatory developments involving its product candidates and its ability to obtain additional funding to support its operations. Risk factors that may cause actual results to differ are more fully discussed in Anadys' SEC filings, including Anadys' Form 10-K for the year ended December 31, 2007 and Anadys’ most recent Form 10-Q. All forward-looking statements are qualified in their entirety by this cautionary statement. Anadys is providing this information as of this date and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
Anadys Pharmaceuticals, Inc. Condensed Consolidated Statements of Operations
| (In thousands except per share amounts) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| (Unaudited) | |||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
| 2008 | 2007 | 2008 | 2007 | ||||||||||||
| Revenues | $ | — | $ | 21,489 | $ | — | $ 23,892 | ||||||||
| Operating expenses Research and development (1) | 7,581 | 7,602 | 19,091 | 21,275 | |||||||||||
| General and administrative | 2,084 | 2,444 | 6,104 | 6,844 | |||||||||||
| Total operating expenses (2) | 9,665 | 10,046 | 25,195 | 28,119 | |||||||||||
| Interest income and other, net | 316 | 864 | 1,311 | 2,855 | |||||||||||
| Net (loss) income (2) | $ (9,349 | ) | $ 12,307 | $ (23,884 | ) | $ (1,372 | ) | ||||||||
| Net (loss) income per share, basic and diluted (2) | $ (0.32 | ) | $ 0.43 | $ (0.83 | ) | $ (0.05 | ) | ||||||||
| Share used in calculating net (loss) | |||||||||||||||
| income per share, basic and diluted | 28,775 | 28,651 | 28,734 | 28,637 | |||||||||||
Anadys Pharmaceuticals, Inc. Condensed Consolidated Balance Sheets
| (In thousands) | |||
|---|---|---|---|
| September 30, | December 31, | ||
| 2008 | 2007 | ||
| (Unaudited) | (Audited) | ||
| Assets | |||
| Cash, cash equivalents and securities available-for-sale | $ 34,352 | $ 56,495 | |
| Other current assets | 2,442 | 1,004 | |
| Noncurrent assets | 1,999 | 4,027 | |
| Total assets | $ 38,793 | $ 61,526 | |
| Liabilities and Stockholders’ Equity | |||
| Current liabilities | $ | 5,549 | $ 5,415 |
| Other long-term liabilities | 38 | 432 | |
| Stockholders’ equity | 33,206 | 55,679 | |
| Total liabilities and stockholders’ equity | $ 38,793 | $ 61,526 | |