- narrowed net loss to $1.4m in qtr - 2 cents per share
- ~$5.1m raised in 1q2011 (3.2m warrants at $1.50 and 0.2m options)
- methotrexate (MTX): pressure assisted jet device. rapid enrollment rate in clinical trial is validation of physician interest. could launch 2013 accoridng to current plan
- recently held discussion w/ EU officicals- the US path should be largely sufficient (see below from q&a). would file slightly after US filing. will seek partner for EU commercialization
- Tjet human growth hormone (Teva) continues to perform ahead of expectations-leading to increased royalties
- Tjet encouraging new pt starts in march and new manage care wins
- ferring (HgH in EU)- new markets and increased sales in existng mkts
- epipen: continue to make progress but no comment due to litigation
- redesigned 2nd device (resubmitted in 2010) currently under active FDA review, hope for 2011 approval
- first pen filed w/in next 12 months by Teva
- 2nd pen- PK studies done. will progress into clinical studies (no date given)
- anturol- pdufa 12/8/11. expect p3 data summer 2011 at appropriate medical meeting
- expect to conclude anturol partnering transaction, see interest from a number of potential partners
- libigel- p3 efficacy enrolled and data fall 2011. AIS received 25% of licensing and milestone fees from BPAX
- elestrin sales showing steady growth (relaunched and marketed by Azur)
- nesterone contraceptive gel -continue to look for potential partners with the population council, have some initial interest.
- $3.6m total revenues. Of this, product sales $1.4m. licensing/development rev $1.4m; royalties up 87% to $0.7m from $0.4m in 1q2010
- r&d expense down to $1.7m in 1q2011 due to anturol study/nda complete
- $13.1m cash 3/31/11- more than 12 months cash w/o any new deals/milestones
- q&a session:
- matt kaplan:
- MTX data summer 2011 from primary clinical trial, just in the process of completing this now. use of vibex mtx shows PK behavior that is approp for tx of RA pts. compare to other dosage forms. then meet w/ fda before filing NDA 1q2012.
- not required and don't expect to need long term RA efficacy studies
- have met with EU regulatory body- they agreed with their plan. small amt of additional CMC work, not more clinical work needed. canada and eu filings shortly after US> have had some intial partner interest already
- anturol- pleased with where they are in disucssions and leave it at that, plan to partner before approval.
- epipen- worst case goes to trial 2/2012. believe have strong position- think case is delay tactic. mentioned settlement as possibility.
- 2nd injector product is generic, so no potential for litigation
- roth capital:
- MTX- couple months ahead of schedule on enrollment/dosing. one site had 10 pts ready before had IND clearance. have not annoucned # pts in this or future studies for competitive reasons.
- involved in bpax bus dev discussions? we are in touch regarding future of libigel. working with bpax to ensure both companies get a good deal. hope that any potential partner wuld want worldwide rights, so then AIS would have to be involved. hope for significant partner fairly soon.
- 10.8m warrants outstanding. $2 strike due in july 2012 (4m) 1m to LLY $3.78 exp 2013. 5m exp 2014 at $1-1.10.
- question re breakdown of US/international sales...will be in 10q filed today