Ariad 4Q / Year End Conference Call
General Impressions: Nothing much to report, so the notes are quite boring. Lots of cash burning this year because they're working hard to expand ponatinib / iclusig use as well as trying to re-play the ponatinib script with the next drug 113. Only small tidbits that I could pick up on was that ponatinib is under-reported in the IMS numbers and that they don't capture academic centers... I think these are the places where earlier / more aggressive use of ponatinib is more likely.
As for 113, they seem to want to maximize the dose and were speaking a lot about EGF-R WT / mutant in lung cancer. I know that they have previously seen some activity here, but the vague chatter makes me think that they're seen a little more since the last update.
Prepared Remarks
- cash used in operations in 2013 will be ~255-265 M
- R&D expenses will be ~238-248 M (8-10% on discovery research, remaining split 3:1 in favour of Iclusig)
- 164 M at the end of 2012, with 310 M raised in early 2013
- 195-205 left in 2013; sufficient to move into 4Q 2014
- currently using sell-through method for iclusig... recognize revenue when shipped to patient
- expected to transition to sell-in (upon shipment) when they have sufficient experience to support this approach
- no guidance right now on 2013 revenues
- Ariad Europe has been set up with country managers and field force is being slowly hired; looking to be ready by July 1, 2013
- MAA under review and expect response in Q3 2013
- Canada, Switzerland and Australia responses due in 2H2013
- EPIC trial continues and anticipate full enrollment by year end; includes interim analysis when 250 patients have been on trial for 1 year (expect mid 2014)
- expect to file for regulatory approval in Japan in mid 2014
- randomized phase 3 SPIRIT3 in collaboration with UK national cancer research institute... switching patients who have been treated in first line TKI upon suboptimal response or treatment failure
- 113... transition to phase 2 expansion cohort in 1H2013
- planning pivotal trial in 113 in ALK+ NSCLC patients resistant to crizotinib
- for iclusig, they have transitioned 50 of the 100 compassionate use patients onto drug
- 100 unique prescribers of iclusig to date (gives a vague floor for the # of prescriptions)
- they say IMS has about 40% capture rate right now on the actual prescriptions; does not capture academic centers
Question and Answer
- no info on whether they've reached MTD on 113... last update was that they're at the 300 mg dose level; next update at ASCO
- they're seeing use of Iclusig in patients following 1, 2 or 3 TKI failures
- last PK data shows that blood levels of 113 exceed IC50 for ALK and EGF-R and their mutants... they say they want to substantially exceed, which suggests they'd be happier to go higher to better get at EGF-R and its variants
- no new drug candidate to hit the clinic this year
