Cost of goods sold only 19 percent of net sales. This drug would make fortunes if they could sell more. Some economics of scale and it would be like printing money...
I think poor sales can be at least partly result of limited supply. There is over 60k pharmacies in USA and with current script numbers on average every 2.5 years someone comes with A script. I do not think many pharmacies have A in stock.
I do not think that trial design will be an issue. Keryx has a good track record with Auryxia (EMA, Japan and FDA approvals). Perifosine was simply a drug that was not working. I do not think that it failed because of the trial design.
Additionally, they had a meeting with the FDA before P3 to discuss the potential path forward for Auryxia and CKD (read for example Q4 2013 earnings call transcript). I think endpoints and inclusion/exclusion criteria were submitted by FDA.
I prefer buyout soon. Insiders bonuses and free shares are diluting 6,5 percent per year. Greg is hiring more tools like crazy and all he and his team can deliver is 350 scripts weekly. 10 year exclusivity in Europe is running out day by day.
After reading carefully 14A filing page 47 my take is: If the increase in the authorized shares is not approved by Annual meeting then the contingently convertible portion of the Notes can be settled in cash. Interestingly the cash sum is not $3.74 but the volume-weighted average price of common stock over a five trading day period before July 1, 2016. So Baupost thinks that share price will be much higher than $3.74 in late June (probably close to announced buyout price).
Probably the other hint is that new appointments to the board are effective immediately. There must be something urgent on the board`s table.
"as mentioned, notes totaling 16.2 million shares have already been converted, ~48.5% of total notes)..."
After reading carefully the filing, I do not think that any of the notes have already been converted.
I do not think that Keryx and akba are future mergers. Baupost has no position in akba. Butler has lot of experience from renal business (from 2002 until 2010, Mr. Butler led Genzyme’s renal division) and maybe Seth knows him.
"We have no specific understandings, arrangements or agreements with respect to any future acquisitions that would require us to issue a material amount of the additional new shares of our common stock"
There should at least couple of thousand anemic elderly wealthy Americans who can afford to pay $8000 annually for much better quality of life. 500 additional weekly off label scripts weekly would be nice.
Do you think that IV iron, epo or red blood cell transfusions are cheap. You have to go to hospital or dialysis center to get them.
In P2 mean Hgb went from 10.5 to 11 and only 40 percent responded by 1g/dl .
So better results in P3.
Do you think that decrease in phosphate is the reason why FC is not used in non-CKD anemia?