- I am doing some housekeeping on the ADLR research page. ADLR stock has been on a tremendous run lately, thanks to upcoming phase 2 data as well as recent comments by the CEO hinting at M&A activity following that event and the recent reacquisition of Entereg rights from GSK.
- See below the jump for notes from a couple more webcasts that did not make it into the blog on the first go-around- 4/6/11 Needham conference and 4/28/11 1q2011 earnings conference call
- ASCRS mtg 5/14-18/2011 (#P267) present entereg data study (update - click here for link with complete abstracts)
- ADL-5945 data expected 3q11
- The above trial will use patient-reported outcomes instrument- designed to FDA specs, being used in p2 OIC studies
- OIC program: have COM patents both molecules til 2025
- ADL-6906 p2 ready for pain
- 1q2011 results late april
- doing everything possible to ensure OIC pgm is ready for p3 on completion of ongoing p2. goal start studies early 2012 (2 pivotal 12 wk efficacy and 12 month safety study, "a couple thousand" pts total)
- ADL-7445 more similar chemically to entereg vs ADL-5945 (perhaps part of why 5945 was advanced first due to worries of cardiac tox)
- PK of 5945 is especially condusive to this population
- Entereg sales enter 2011 at $30m runrate, expect it to grow, still "difficult to project."
- Click here to read the company press release
- Entereg net sales up 42% y/y 1q11 vs 1q10- includes a price increase (see q&a notes below)
- first quarter is the most challenging for companies that sell into hospital market
- $30m run rate marks level of sales where entereg is breakeven for ADLR (so cost of goods, marketing etc, ADLR sales force, and 55% share to GSK total up to ~$30m on annual basis)
- Have registered 70% of the 1600 leading hospital. 50% of these have reordered Entereg
- Most of the sales efforts now focus on increasing sales at exisitng prescribing hospitals, with some effort to get new hospitals registered
- OIC phase 2 trial enrollment progressing nicely, on schedule to report data 3q2011 - total of 200 pts
- Goal is to partner the OIC program later this year and proceed into pivotal trials in 2012
- ADLR is engaged in partner discussions now. In the industry there is a good deal of interest in this field (didn't comment on the level of interest in this particular product though...)
- $39.3m cash 3/31...burned 7.3m in 1q2011
- q&a session:
- Entereg took a 6% price increase April 2010 and a 9% increase january 2011 based on performance of product and publications of health economics benefit
- Entereg unit sales decrased from 4q10 to 1q11. Saw procedure #'s in 1q that are down from year-end levels. Excuses given were: yearend hosptial buying, annual insurance deductible issues for patients in 1q, and trends in patient scheduling of elective procedures (pretty pathetic in my opinion)
- 1q11 over 1q10 demand of Entereg up 20-25% (ie, rest of the 42% sales increase came from price increases)
- Question re why not sell right now since will obviously need more cash..."as one projects forward, we will have a need to finance"...goal is to do so via partnering OIC pgm, think this optimizes shareholder value.