Idenix Pharmaceuticals (IDIX) reported a loss of 22 cents per share in the third quarter of 2013, wider than the Zacks Consensus Estimate loss of 21 cents. The year-ago net income was 10 cents.
Third-quarter revenues plunged to $0.1 million from $32.2 million and were significantly below the Zacks Consensus Estimate of $2 million.
Research and development expense surged 60.9% year over year to $21.7 million. General and administrative expense surged 40.0% year over year to $8.6 million.
Idenix expects its current cash balance of $148.8 million to be sufficient to sustain its operations through 2014.
We remind investors that Idenix suffered a setback in Jun 2013 when the U.S. Food and Drug Administration (:FDA) asked the company to provide additional preclinical safety information on its lead uridine nucleotide prodrug candidate, IDX20963.
IDX20963 is being developed for the treatment of hepatitis C virus (:HCV). The study has been put on hold. Nevertheless, Idenix is working to resolve this issue with the FDA and develop IDX20963 outside the U.S.
On the other hand, Idenix’s IDX21437, a next-generation uridine nucleotide prodrug inhibitor which is also being developed for the treatment of HCV has received approval for clinical trials in Canada and Belgium. The enrollment process is ongoing.
Meanwhile, in May 2013, Idenix initiated a phase II study (HELIX-1), evaluating the combination of HCV candidates, samatasvir (IDX719) and simeprevir (TMC435). The study is being conducted in collaboration with Janssen Pharmaceuticals, Inc., a Johnson & Johnson (JNJ) company.
The study is fully enrolled and initial data from the study is expected in the fourth quarter of 2013. Idenix plans to initiate a second phase II trial (HELIX-2) on samatasvir, simeprevir and TMC647055 in 2014.
The results were disappointing with both earnings and revenue missing the estimates.
Nevertheless, we expect progress with other HCV candidates, notwithstanding the clinical hold on the company’s lead uridine nucleotide prodrug candidate, IDX20963.