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Achillion HCV Update
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Achillion Announces Positive Proof-of-Concept Data With ACH-3102
-Second-Generation Pan-Genotypic NS5A Inhibitor Achieves Potent Antiviral Activity of Mean Maximum 3.74 Log10 Reduction Following a Single Dose - - Initiated Enrollment in a Phase 2 Clinical Trial Evaluating ACH-3102 Plus Ribavirin for the Treatment of HCV Genotype 1b-
http://www.natap.org/2012/HCV/100112_03.htm
Achillion Provides Update on Clinical HCV Development Programs
http://www.natap.org/2013/HCV/010213_04.htm
February 20, 2013
Achillion Reports 2012 Fourth Quarter and Year-End Financial Results
- Conference call and webcast to be held today, February 20th, at 5:00 pm EST -
NEW HAVEN, Conn., Feb. 20, 2013 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today reported financial results for the three and twelve months ended December 31, 2012.
For the three months ended December 31, 2012, the Company reported a net loss of $11.2 million, compared to a net loss of $12.4 million in the three months ended December 31, 2011. For the full year ended December 31, 2012, the Company's net loss was $47.1 million, compared to a net loss of $44.2 million for the year ended December 31, 2011. Cash and cash equivalents and marketable securities at December 31, 2012 were $77.4 million.
Recent HCV Pipeline Accomplishments
· Announced plans to initiate in the second quarter of 2013 a Phase 2 clinical trial evaluating 12 weeks of therapy consisting of sovaprevir and ACH-3102, with ribavirin, for the treatment of genotype 1 treatment-naive HCV;
· Reported interim Phase 2 results indicating that six out of eight patients receiving 12 weeks of therapy consisting of ACH-3102 and ribavirin for the treatment of genotype 1b, IL28B CC genotype, HCV achieved rapid virologic response (RVR) and three out of three patients who completed treatment also remained HCV RNA undetectable four weeks after completion of therapy (SVR4); and
· Achieved Phase 1 proof-of-concept with once daily ACH-2684, a second generation protease inhibitor, in genotype 1 HCV patients, with and without cirrhosis.
Anticipated Clinical Milestones for 2013
ACH-3102: Phase 2 second-generation NS5A inhibitor
· Expand the Phase 2 clinical trial evaluating 12 weeks of therapy consisting of ACH-3102 and ribavirin, for the treatment of genotype 1b treatment-naive HCV during the second quarter of 2013;
· Report SVR4 results following 12 weeks of therapy consisting of ACH-3102 and ribavirin for the treatment of genotype 1b, IL28B CC genotype, HCV in the second quarter of 2013; and
· Provide RVR results from the Phase 2 trial of ACH-3102 and ribavirin for genotype 1b treatment-naive HCV during the third quarter of 2013.
Combination of sovaprevir and ACH-3102 for the treatment of genotype 1 HCV
· Initiate dosing patients in a Phase 2 trial evaluating 12 weeks of sovaprevir and ACH-3102, with ribavirin, for the treatment of genotype 1 HCV during the second quarter of 2013; and
· Report interim Phase 2 results from this first sovaprevir and ACH-3102 combination, including RVR, during the third quarter of 2013.
Fourth Quarter 2012 Financial Results
The Company reported a net loss of $11.2 million for the three months ended December 31, 2012, compared to a net loss of $12.4 million for the three months ended December 31, 2011. Research and development expenses were $8.4 million in the fourth quarter of 2012, compared to $9.9 million for the same period of 2011, the decrease primarily resulting from the timing of clinical trial activities, offset by an increase in development group personnel. Revenue for the three months ended December 31, 2012 totaled $118,000 compared to $62,000 in the three months ended December 31, 2011.
For the three months ended December 31, 2012, general and administrative expenses totaled $2.9 million, compared to $2.6 million in the same period in 2011, the increase primarily resulting from higher business development and professional services fees.
Year-end 2012 Financial Results
For the year ended December 31, 2012, the Company reported a net loss of $47.1 million, compared to a net loss of $44.2 million in 2011. For the year ended December 31, 2012, research and development expenses totaled $39.0 million, compared to $35.4 million in 2011. The increase in research and development expenses was primarily a result of increased personnel levels and increased clinical trial costs associated with the development of sovaprevir and ACH-3102, offset by decreased manufacturing expenses for ACH-2684.
Total revenues were $2.6 million for the year ended December 31, 2012, compared to $247,000 for the year ended December 31, 2011. The majority of revenue during 2012 was related to recognition of $2.5 million of deferred revenue under the Company's former collaboration with Gilead Sciences, Inc.
General and administrative expenses were $10.9 million for the year ended December 31, 2012, compared to $9.2 million for the year ended December 31, 2011, the increase primarily resulting from increased non-cash stock compensation combined with increased business development and professional services fees.
2013 Financial Guidance
At December 31, 2012, Achillion had cash and cash equivalents and marketable securities of approximately $77.4 million. The Company expects that research and development expenses during 2013 will be approximately $50 million and that net cash used in operating activities in 2013 will approximate $55 million based on current operating plans, anticipated timelines and the estimated cost of clinical trials and product development programs. The net loss per share is anticipated to approximate $0.75 per share.
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Achillion Pharmaceuticals Announces Proposed Public Offering of Common Stock
February 20, 2013
NEW HAVEN, Conn., Feb. 20, 2013 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) announced today that it has commenced an underwritten public offering of $125 million of its common stock. In connection with this offering, Achillion plans to grant the underwriters a 30-day option to purchase additional shares of its common stock. Citigroup and Leerink Swann LLC are acting as joint book-running managers for the offering. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
The offering is being made by Achillion pursuant to a shelf registration statement on Form S-3 previously filed with the Securities and Exchange Commission (SEC), which the SEC declared effective on November 21, 2012. A preliminary prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC's website located at http://www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus relating to this offering may be obtained from Citigroup, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, via telephone at 1-800-831-9146 or email at batprospectusdept@citi.com or from Leerink Swann LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, via telephone number (800) 808-7525, Ext. 4814, or email at syndicate@leerink.com.
This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor will there be any sale of, these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state or other jurisdiction.
About Achillion Pharmaceuticals, Inc.
Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease.
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