Some high points from Briefing.com:
7:43 am Ariad Pharm beats by $0.07, beats on revs; provides clinical trial updates ( ARIA) : Reports Q4 (Dec) loss of $0.40 per share, $0.07 better than the Capital IQ Consensus Estimate of ($0.47); revenues rose 11251.4% year/year to $8.4 mln vs the $6.31 mln consensus. Net loss was $0.36 per share, for the same period in 2012. The increase in net loss is primarily due to an increase in operating expenses of $21.6 million, reflecting commercialization of Iclusig, as well as continued development of marketed product and product candidates, offset in part by Iclusig product revenues noted above.
Cash Position
As of December 31, 2013, cash, cash equivalents and marketable securities totaled $237.2 million, compared to $164.4 million at December 31, 2012.
Financial Guidance for 2014
Co anticipate cash used in operations in 2014 to range from $165 million to $175 million. Guidance includes: Research and development expenses of $140 million to $150 million, reflecting development activities for Iclusig and AP26113, and ongoing discovery research efforts. Expenses related to Iclusig represent ~75% of total research and development expenses
Clinical updates
Iclusig was re-launched in the U.S. in mid-January with all members of the commercial team in place. Through the first five weeks of commercialization, approximately 180 out of 305 patients from the single-patient IND program have transitioned to commercial supply. We anticipate that approximately 50 additional patients will transition by the end of this quarter.
Additionally, we expect that 7% to 10% of patients from the IND program will remain on Iclusig but will qualify for free drug through co's patient assistance program. As expected, the remaining 18% to 20% of patients, predominantly those with advanced phase disease, will discontinue Iclusig from the IND program.
Co anticipates the majority of the remaining EU pricing approvals will occur in the second half of 2014.
Iclusig Clinical Development - A new clinical trial for Iclusig will begin in the second half of 2014 as part of FDA post-marketing requirements.Patient enrollment and follow up in the Phase 2 portion of the Phase 1/2 clinical trial of AP26113 are ongoing, and we plan to begin a pivotal Phase 2 trial of AP26113 in ALK+ non-small cell lung cancer patients resistant to crizotinib later in the first quarter of this year. We expect this trial to be the basis for co's initial registration of AP26113. Co expects to nominate a potential best-in-class development candidate in the second half of 2014. This compound is a product of co's internal discovery program driven by structure-based drug design. The candidate will be an orally active small-molecule drug, targeted against an oncogenic kinase in a class that is well understood and clinically validated, but with a unique target product profile. |
