- "noteworthy that is our second consecutive profitable qtr"
- no need to raise capital to run day to day operations (10q leaves open possibility of raising funds to acquire company or in-license drugs)
- plan to file 2 NDAs in 2012 (Belinostat has slipped from earlier 2011 guidance), one could be approved 2012 (Belinostat), one in 2013 (Apaziquone)
- colon cancer indication: 145k cases/yr in US. Fusilev already a successful drug in europe and japan despite generic competition w/o shortage ($PFE, $SNY, takeda together >$180m annually). believe $SPPI can generate $200m per yr eventually. strong US patent protection
- ramped up Fusilev supply starting 2h2010. Received EU product in Feb 2011 to label and supply to pts in US. Expanded manuf to include several new sites. "limited supply will soon be behind us'
- zevalin is apparently now the "second" revENUE generating drug (funny how it used to be the main attraction)
- Excuses for poor 1q11 Zev sales: copays reset 1/1. "2q sales off to a great start." april sales ~$3m. annaul sales will continue to grow gradually. further growth after bioscan removal. pdufa 11/20/11
- annual zev sales could exceed $100m. 5% penetration in indolent NHL could mean $300m sales. 'good pharmacoeconomic proposition"
- final clinical apaziquone evaluations dec 2011. lock database, analyze, then file NDA 2012
- belinostat. 100+ PTCL sites, complete enrollment 2011, file NDA 2012.
- each of these drugs has a greater market potential than fusilev/zevalin
- zev- will initiate study in agressive lymphoma
- believe there are other gems in the portfolio (seems like its been 2 years since we heard about any other candidates though).
- Fusilev is a lyophilized product- can only produce batches of 10-30k vials. need larger vial size for CRC- 175mg per vial ready to use. old- inject water, shake, leave sitting.
- Q&A Session:
- large receivable on balance sheet because most sales occurred at end of feb and march; customers have 60-75 days to make payment.
- AR>total sales for qtr because revenues booked net of expected rebates, chargebacks, etc
- marketing points for fusilev? "easy launch" b/c of doctor familiarity. know to use in different dosage. 1) approval for CRC 2) ready and sustainable supply 3) reimbursement [to me these aren't really marketing points to convince someone to choose Fusilev over generic]
- Additional fusilev studies planned? one or more studies for further use of fusilev for CRC. "Still don't know if we have the right dose" compare equal mg doses 400mg/m2 Fusilev vs leucovorin. believe can show safety and efficacy advantage (why not start this trial long ago!?)
- leucovorin (generic) has add'l label for first line use. fusilev only for 2nd/3rd line. SPPI's label fits w/ orphan drug designation- thought this was more impt that 1st line converage b/c believe will be reimbursemnt for adjuvant and localized disease
- Fusilev patent thru- end of 2019. orphan drug thru 2018. so unlikely for generic at risk launch
- The new planned Zevalin trial will be conducted w/o bioscan (don't have to wait for PDUFA to start this trial). will conduct will SPA (but don't have this yet). on track to start by ye11
- analyst- generic should be available later this month
- "nightmare" for providers to switch back and forth between doses (huh?..this doesn't hold water to me)..."will have switching back in some cases but believe bulk of drs will cont w/ fusilev."
- eur/japan fusilev used 10x more often than generic
- agrressive lymphona- fundamentally diff disease. (NHL- slow, multiple relapse over 10-15 yrs)...instead, cure upfront or relapse and have only one choice- stem cell transplant...maintanence rituxan does not provide any benefit
- Design of new Zevalin trial- upfront CHOP/ritux, responders randomized to observation or Zev. outcome OS
- why y/y Zevalin down? copay excuse doesnt fly for this. do you expect y/y full yr growth? think 2011 will be higher than 29m in 2010. higher "year after year" but no answer to Q
- Fusilev new CRC trial design- stratisfy based on risk factors and randomize. follow safety and outcome of PFS and OS. size under discussion. 800-1000 pts at largest depending on assumptions. can enroll v rapidly. topline data such as safety comparisons can read out rapidly. survial maybe 3 years start to finish. target initialization end of 2011
- are seeing a number of new accts ordering zev. no hard #s
- apaz-japan pgm. first repeat PK, this is almost enrolled. within next 2q's will begin formal bridging studies.
- on track to initiate Apaz. high risk baldder cancer trial in next 3 months
- no PTCL top line data presented at ash 2011
- excuse 1q11 vs 1q10 decline is mix of govt vs private payers (if this is true, should have bene prepared with hard numbers)
- Increase sales force size after Fusilev approval? now need to call on solid tumor and lymphoma specialists- "small impact on size of force"
- Inc r&d spend-no 2012 guidance, but sounds like could be higher than 2011. major expense of the new trails would be 2012 and 2013, not 2011.
- hope for belinostat revenue in 2012