
James T. Glover Ian Stone or David Schull SVP, Operations & CFO Russo Partners, LLC Anadys Pharmaceuticals, Inc. (619) 814-3510
(858) 530-3763 ian.stone@russopartnersllc.com jglover@anadyspharma.com david.schull@russopartnersllc.com
San Diego, July 30, 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 second quarter ended June 30, 2008.
"The first half of 2008 has been a remarkably productive time at Anadys," said Steve Worland, Ph.D., President and CEO. "Through the focused efforts of our employees, we have initiated dosing in three clinical programs in six months. For hepatitis C, we commenced dosing in our Phase I clinical trial of ANA598 during the second quarter, and are happy to announce today that we have now commenced dosing in our Phase I clinical trial of ANA773 for HCV. We also continue to enroll patients in our ongoing clinical trial of ANA773 for oncology. We are proud of our progress to date and look forward to achieving additional clinical milestones in the coming months.”
As of June 30, 2008, the Company’s cash, cash equivalents and securities available-for-sale totaled $42.1 million.
During the second quarter of 2008 the Company had no revenue, compared to $1.3 million for the same quarter of 2007. The revenue in the second quarter of 2007 was primarily derived from the amortization of an upfront payment and a milestone payment under a prior collaboration.
Research and development expenses were $5.5 million for the second quarter of 2008, compared to $7.0 million for the second quarter of 2007. The $1.5 million decrease primarily resulted from cost savings derived from Anadys’ completed strategic restructuring and associated termination of prior development programs. The decrease was partially offset by an increase in development costs for ANA773 in the second quarter of 2008.
General and administrative expenses were $2.0 million for the second quarter of 2008, compared to $2.3 million for the second quarter of 2007. The $0.3 million decrease primarily resulted from cost savings derived from Anadys’ completed strategic restructuring.
Operating expenses were $7.5 million for the second quarter of 2008, compared to $9.3 million for the second quarter of 2007. Included as a component of Anadys’ operating expenses were non-cash, share-based expenses of $0.7 million and $1.0 million for the second quarter of 2008 and 2007, respectively.
The net loss was $7.1 million for the second quarter of 2008, compared to a net loss of $7.0 million for the second quarter of 2007. Basic and diluted net loss per common share was $0.25 in the second quarter of 2008, compared to $0.24 in the second quarter of 2007. Non-cash share-based expense resulted in a $0.02 and $0.04 increase in basic and diluted net loss per share for the three months ended June 30, 2008 and 2007, respectively.
During the six months ended June 30, 2008 the Company had no revenue, compared to $2.4 million for the same period in 2007. The revenue recognized in the first six months of 2007 was primarily derived from the amortization of an upfront payment and a milestone payment under a prior collaboration. For the six months ended June 30, 2008, Anadys reported a net loss of $14.5 million, compared to $13.7 million for the same period last year. Basic and diluted net loss per common share was $0.51 for the six months ended June 30, 2008, compared to $0.48 for the same period in 2007.
Anadys will host a conference call at 5:00 p.m. EDT today to discuss its second 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 617-801-6888 (international), passcode 79911148. The webcast and telephone replay will be available through August 13, 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 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 occurrence, timing and pace of future clinical trials, and 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 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 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 future products 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.
Condensed Consolidated Financial Statements
| Anadys Pharmaceuticals, Inc. | |
|---|---|
| Condensed Consolidated Statements of Operations | |
| (In thousands except per share amounts) | |
| (Unaudited) | |
| Three Months Ended June 30, Six Months Ended June 30, | |
| 2008 2007 2008 2007 | |
| Revenues $ — $ 1,302 $ — $ 2,404 | |
| Operating expenses | |
| Research and development (1) 5,501 6,975 11,510 13,673 | |
| General and administrative 1,975 2,282 4,020 4,401 | |
| Total operating expenses (2) 7,476 9,257 15,530 18,074 | |
| Interest income and other, net 384 959 995 1,991 | |
| Net loss (2) $ (7,092 ) $ (6,996 ) $ (14,535 ) $ (13,679 | ) |
| Net loss per share, basic and diluted (2) $ (0.25 ) $ (0.24 ) $ (0.51 ) $ (0.48 | ) |
| Share used in calculating net loss per | |
| share, basic and diluted 28,731 28,638 28,714 28,629 | |
| (1) Includes $-and $317 as an offset in research and development expense, which represents an estimate of the net | |
| reimbursement by Novartis of ANA975 research and development costs for the three months ended June 30, 2008 | |
| and 2007, respectively. Includes $43 and $592 as an offset in research and development expense, which represents | |
| an estimate of the net reimbursement by Novartis of ANA975 research and development costs for the six months | |
| ended June 30, 2008 and 2007, respectively. | |
| (2) Includes non-cash operating expenses of $668 and $1,019 determined in accordance with Statement of Financial | |
| Accounts Standards No. 123(R), “Share-Based Payment” (SFAS No. 123(R)) or approximately $0.02 and $0.04 | |
| effect on basic and diluted net loss per common share for the three months ended June 30, 2008 and 2007, | |
| respectively. Research and development expense and general and administrative expense includes $313 and $355 of | |
| non-cash operating expenses determined in accordance with SFAS No. 123(R) for the three months ended June 30, | |
| 2008. Includes non-cash operating expenses of $1,329 and $2,108 determined in accordance with SFAS No. 123(R) | |
| or approximately $0.05 and $0.07 effect on basic and diluted net loss per common share for the six months ended | |
| June 30, 2008 and 2007, respectively. Research and development expense and general and administrative expense | |
| includes $623 and $706 of non-cash operating expenses determined in accordance with SFAS No. 123(R) for the six | |
| months ended June 30, 2008. | |
| Anadys Pharmaceuticals, Inc. Condensed Consolidated Balance Sheets (In thousands) | ||||
|---|---|---|---|---|
| Assets | June 30, 2008 (Unaudited) | December 31, 2007 (Audited) | ||
| Cash, cash equivalents and securities available-for-sale Other current assets Noncurrent assets Total assets | $ 42,112 1,276 3,560 $ 46,948 | $ $ | 56,495 1,004 4,027 61,526 | |
| Liabilities and Stockholders’ Equity | ||||
| Current liabilities Other long-term liabilities Stockholders’ equity Total liabilities and stockholders’ equity | $ 4,140 124 42,684 $ 46,948 | $ $ | 5,415 432 55,679 61,526 | |