- CBST is partnered with Optimer Pharma $OPTR to promote Dificid.
- Check out the complete schedule of Upcoming Events with links to my notes.
- Here are my notes from the webcast:
- Cubicin: 1.3m patients treated to date
- new Orange Book patent listing - important because teva exclusive supplier arrangement goes thru end of last OB patent expiration
- cxa-201: if approved in all targeted indications it would reach >$1b sales with single digit market share
- '315 CDAD phase 3 program will begin 1h2012. if successful, investment will generate IRR of >25% [I got this one wrong...thought they would kill the program]
- gross cubicin revenues up 23% y/y, raised full year 2011 sales guidance by $25-35m
- cash guidance for ~$1b year end, "as always, subject to any other business development activity completed by year end" [said this with heavy emphasis...makes sense in retrospect based on Adolor acquisition announced a short time later]
- Merck $MRK has now launched cubicin in japan, predict peak $100m sales there.
- 11/4 FDA will hold hearing re draft guidance for HAP/VAP (pneumonia) drug development
- pending completion of toxicology studies with an acceptable profile, by ye2011 we'll have an IND filing (phase 1 in 2012) for new discovery program- TrpA1 ion channel inhibitor candidate for pain/inflammation
- no cubicin stocked by major wholesalers, so 3rd party data source can be inaccurate and is off by up to 60% on month to month basis. We didn't see anything to explain reporteed level of sales in the quarter except demand- no inventory build anywhere in channel
- no comment yet on cost for HAP program phase 3 trials
- 2012 expenses- will see substantial increase in R&D line.
- Worldwide '315 forecast revenue in the $400-500m range at peak with healthy margin based on very modest share assumptions. no comment on size of market overall, but "$1b" is not an unreasonable assumption for branded products
- differentiation for '315? largest unmet medical need is need to deal with relapse - even with dificid, there will be a lot of churn in this market as prescriber tries a drug with different mechanism of action after relapse
- adding Dificid to bag has improved access for cubicin
- phase 3 for '315 will not need to be run against dificid, expect comparator to be oral vancomycin
- projections calculated on launching into market with generic vancocin, but we are not predicting a date when that will happen.
- medicare/medicaid discounts reduce gross rev by 6% (accounts for half of gross to net adjustment)...projecting forward based on potential health care reform bill effect, this still doesn't go up past 10% even if all programs enacted (very unlikely).
- 4q2011 and year end conference call will be 5pm thursday 1/19/2012