SAN DIEGO, Feb. 24 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. , a biopharmaceutical company dedicated to improving patient care by developing novel medicines for the treatment of hepatitis C, today reported its financial results and program highlights for the fourth quarter and year ended December 31, 2009.
“In the past year we’ve significantly advanced the development of ANA598, our wholly owned non-nucleoside polymerase inhibitor in development for the treatment of hepatitis C,” said Steve Worland, Ph.D., President and CEO of Anadys. “The twelve week Phase II results announced today demonstrate the ability of ANA598 to significantly accelerate the rate of patients achieving undetectable levels of virus when added to current treatment. The durability of antiviral response through twelve weeks and a very favorable safety profile to date position ANA598 as one of the most attractive and advanced polymerase inhibitors in the HCV development landscape today, ready for clinical trials exploring the use of ANA598 in combination with other direct antivirals.”
Recent Highlights
Today, Anadys reported preliminary results from an ongoing Phase II study demonstrating that 73% of hepatitis C patients treated with 200 mg ANA598 twice daily in combination with pegylated interferon and ribavirin (SOC) achieved undetectable levels of virus (<15 IU/mL) at week 12, known as complete Early Virological Response or cEVR. No patient experienced viral rebound on ANA598. ANA598 was well tolerated through twelve weeks, with no serious adverse events reported and a profile of adverse events in the ANA598 group comparable to the group receiving SOC alone.
Financial Results
As of December 31, 2009, the Company’s cash, cash equivalents and securities available-for-sale totaled $20.5 million compared to $27.9 million as of December 31, 2008. The decrease in cash, cash equivalents and securities available-for-sale is the result of our cash utilization to fund operations during 2009 partially offset by proceeds of approximately $16.0 million received from a “registered direct” offering of common stock and warrants in early June 2009.
Total operating expenses were $5.6 million for the fourth quarter of 2009, compared to $8.9 million for the fourth quarter of 2008. Included as a component of Anadys’ operating expenses were non-cash, share-based expenses of $0.4 million and $0.7 million for the fourth quarter of 2009 and 2008, respectively.
Research and development expenses were $4.0 million for the fourth quarter of 2009, compared to $6.9 million for the fourth quarter of 2008. The $2.9 million decrease was primarily attributable to cost savings associated with our strategic restructuring initiated in June 2009 which included a $1.5 million decrease in ANA773 development costs.
General and administrative expenses were $1.6 million for the fourth quarter of 2009, compared to $2.0 million for the fourth quarter of 2008. The $0.4 million decrease primarily resulted from cost savings associated with our strategic restructuring and the relocation of our corporate headquarters to a smaller facility during July 2009.
The net loss was $4.3 million for the fourth quarter of 2009, compared to a net loss of $8.5 million for the fourth quarter of 2008. Included in the net loss for the fourth quarter of 2009 is a $1.3 million gain resulting from a decrease in the liability associated with our common stock warrants from September 30, 2009 to December 31, 2009. The warrants were issued in connection with our “registered direct” offering in early June 2009. Basic and diluted net loss per common share was $0.11 in the fourth quarter of 2009, compared to $0.30 in the fourth quarter of 2008. Non-cash share-based expense resulted in a $0.01 and $0.02 increase in basic and diluted net loss per share for the fourth quarter of 2009 and 2008, respectively.
For the twelve months ended December 31, 2009, Anadys reported a net loss of $27.3 million, compared to $32.4 million for the same period last year. Basic and diluted net loss per common share was $0.81 and $1.13 for the twelve months ended December 31, 2009 and 2008, respectively.
2009 Development Program Highlights
ANA598-non-nucleoside HCV polymerase inhibitor in Phase II development.
ANA773-oral inducer of endogenous interferons that acts via the toll like receptor 7 (TLR7) pathway.
2009 Operational Highlights
Conference Call Webcast and Slides
Anadys will host a conference call at 5:00 pm Eastern Standard Time today to discuss its fourth quarter year-end 2009 financial results and highlights and to present the 12-week results at 200 mg bid in the ongoing ANA598 Phase II study. A live webcast of the call, including accompanying slides, 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 92658014. The webcast and telephone replay will be available through March 10, 2010.
About Anadys
Anadys Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to improving patient care by developing novel medicines for the treatment of hepatitis C. The Company believes hepatitis C represents a large unmet medical need in which meaningful improvements in treatment outcomes may be attainable with the introduction of new medicines. The Company is developing ANA598, a non-nucleoside polymerase inhibitor for the treatment of hepatitis C. The Company has also investigated the potential of ANA773, an oral, small-molecule inducer of endogenous interferons that acts via the Toll-like receptor 7, or TLR7, pathway in hepatitis C.
Safe Harbor Statement
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 (i) the belief that the durability of antiviral response through twelve weeks and a very favorable safety profile to date position ANA598 as one of the most attractive and advanced polymerase inhibitors in the HCV development landscape today, ready for clinical trials exploring the use of ANA598 in combination with other direct antivirals; (ii) assessments of the safety and tolerability profile of ANA598 based on the 200 mg bid 12 week results; (iii) the ability for patients to achieve a SVR in the ANA598 Phase II study; and (iv) the belief that ANA773 holds promise as a potential replacement for injectable interferon products in HCV therapy. 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 and early clinical studies may not be predictive of future results, and Anadys cannot provide any assurances that ANA598 will not have unforeseen safety issues or will continue to have favorable results as the Phase II trial progresses. 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 transactions 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 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, 2008 and Anadys’ Form 10-Q for the quarter ended September 30, 2009. 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.
(1) Includes non-cash share-based expenses of $384 and $699 or approximately $0.01 and $0.02 effect on basic and diluted net loss per common share for the three months ended December 31, 2009 and 2008, respectively. Research and development expense and general and administrative expense includes $123 and $261, respectively, of non-cash share-based expenses for the three months ended December 31, 2009. Includes non-cash share-based expenses of $2,714 and $2,763 or approximately $0.08 and $0.10 effect on basic and diluted net loss per common share for the twelve months ended December 31, 2009 and 2008, respectively. Research and development expense and general and administrative expense includes $1,354 and $1,360, respectively, of non-cash share-based expenses for the twelve months ended December 31, 2009.
Pegasys(R) and Copegus(R) are registered trademarks of Hoffman-La Roche Inc.
CONTACT: Investors, Amy Conrad of Anadys Pharmaceuticals, Inc.,
+1-858-530-3607, aconrad@anadyspharma.com; or Media, Ian Stone,
ian.stone@russopartnersllc.com, or David Schull,
david.schull@russopartnersllc.com, both of Russo Partners, LLC,
+1-619-528-2220, for Anadys Pharmaceuticals, Inc.
Web site: http://www.anadyspharma.com/
