last attempt: I start to be a little worried when I see statements about Valtessa like it's a $20 billion market and the stock is going to move $100 in a day. Nonetheless, most people agree that for this and ZS9 will comprise a $2-3 billion market, with Valtessa and ZS9 at least splitting the field. Few are expecting ZS9 to get a DDI black box warning, but many are expecting either that 1) it will receive a label warning on hypertension and possibly edema (for sodium sensitive patients), or 2) FDA may require longer term data (1+ years) on ZS9 to see how the battle between the ZS9 'salt bomb' and RAAS drugs fight it out. The one piece of data that we do not know are the number of patients in phase 3 that were in the 140 to 180 systolic range, since the ZS trial used 180/105 as the point for hypertension, which is close to a hypertensive emergency ( 180/120). If the group that fell between 130-180 is a significantly higher percentage than just the 180+ that ZS reported, then that by itself could trigger a black box warning or even additional testing in certain groups to see if there is worsening BP and therefore worsening kidney failure over time. But Valtessa is also not without its faults. E.G. Hypomagnesemia was a common occurrence (7%+) and must be monitored. I think the shorts are betting that a) initial scripts will be low for 4th quarter (the drug launched Oct 22 so only 2 months of scripts), and B) that once ZS9 hits the streets it will sweep the field with better, faster efficacy. Long term data is going to be a key differentiator (or not) for Valtessa, combined with a change in the black box although that change probably isn't going to make much of a difference in uptake anyway. The second full quarter of sales figures should blow away numbers, especially with Medicare approval with six weeks to go before end of Q1. The bottom line is that there isn't a credible argument anywhere that changes the fact that RLP is worth at least 2X to 6X its current cap
"I am perhaps one of the few that do expect a DDI box simply because ZSalt is a "binder" and by definition FDA places a box unless they provide clinical data (which they don't have)."
Good point lurker. As far as the disappearing posts, Yahoo must have it out for me! ;-) (As the joke goes, "look I'm not paranoid - I KNOW everyone is out to get me!!)
As in a 5% penetration represents $1 billion in revenue? That would be a $20 billion market? I don't buy it, at least not for the next 5 to 10 years. I think the market is more like 2 to 5 billion.
why? My point was that even at a $2 billion market, if RLYP gets one billion of it it is worth $3-5 billion in a buyout, and at least 3X what its market cap is right now net of debt and cash. Dream about a $20 billion market all you want, but for me I'm very happy if this triples! Then I'll decide what to do from there!
I missed the conference call. Can you post what the exact nature of the SAE was? And did they say whether the patient was taking RG-1012 in combination with Harvoni, Olysio, or Daklinza? Also did they break out the results between these subgroups? It is interesting if Olysio (and NS3/4A inhibitor) had the same results as Harvoni (and NS5A/NS5B combo).
Um, not if RG-101 needs Harvoni (which it does) to be an effective cure. RG-101 achieved around a 50% cure rate by itself. It is synergistic with a nuke and/or NS3/4 protease inhibitor - no one knows where this comes out. Meanwhile, I think RGLS will be snapped up by J&J for its Janssen subsidiary.
I like the thinking here, but if the zs004e study was supposed to be finished in July 2015, and AZT bought the company in November and finalized the buyout in Decrmber, don't you think they would have seen all that data prior to completion of the buyout? If the data were horrible, why would they have completed the buy?
233 outpatient scripts written and filled, but they say 1,229 outpatients scripts have been written in that period, or about 1,000 that are written and as of yet unfilled. That could mean a big burst of scripts in February, but you can't tell from the numbers as presented. Don't know how long it takes t fill a script, but if we got 1,000 in the last two weeks, that bodes well for next quarter! Maybe the conf call can clarify.
no I don't think so. The chart and the 1,229 are apples and oranges. The chart shows free samples plus orders filled in hospital and outpatient. The 1,229 is just written scripts, period. So you have to compare written (1,229) versus written and filled (233).
Ok I read it and stand corrected. 800 are free samples which are still written scripts, but the free samples are given while insurance and formulary issues are being worked out. Do you agree?
I don't know if shorts believe that Veltassa is a redux of Auryxia from Keryx or what, but they act like this is going to be another low revenue, high cash burn company. The numbers for February and March are going to be critical, and they are going to need to show exponential and not just incremental growth on the scripts, in order for the shorts to get nervous. Regardless, you can see how in charge they are: the stock opens at 14.96, rises up to 16.69, letting all the longs back into their little trap, and then they push the price right back down to $14. I got out at $17 yesterday before earnings and 'm staying out until there is more visibility on the ramp rate. 20 of the 6000-8000 nephrologists is 1200-1600. If each one has initially 5 qualified patients, we are looking at a reasonably quick ramp to 6000-8000 scripts in short order. But we need to see something dramatic in the next 2-3 months, specially given e high burn rate. We've got 133 salespeople, Sanofi, and Fresenius all pushing this. Another 1000 scripts for February won't cut it, IMHO.
Nobody knows more about loss carry forwards and how they can be used than the CFO of an inquiring company, so no subtle hints need to be given to anyone. This is boilerplate language. I'm afraid you're grasping at straws- not about a potential buyout, but about reading anything into this line.
My take on the money spend, as some have suggested, is that Orwin is trying to shore up as much market share as possible, educate docs as much as possible about Veltassa's long term benefits, and expand the label as quickly as possible before AZT's 6,000 member sales force hits the streets, where a sizable portion are focused on cardio and nephrology: From their website:
"AstraZeneca has a patient-centric approach to disease treatment, so we are tackling multiple risk factors by uniting our cardiovascular (CV), metabolic and chronic kidney disease (CKD) disease areas into one integrated approach – cardiovascular and metabolic disease (CVMD).
This approach means we look at the CVMD patient as a whole, rather than by disease area, because we know that cardiovascular disease (CVD) is a well-known consequence of diabetes and CKD. Each of our focus areas seek to further reduce cardiovascular morbidity and mortality, and organ damage by addressing multiple CV risk factors."
Yes, RLYP has Sanofi selling too, but they are simply in a servicing agreement - not the same as a company's own drug where profits are much, much higher. So I'm all in favor of Orwin spending like there's no tomorrow, because now through June 1 is make or break in getting Veltassa entrenched in the market. Even though its a better drug, AZT could drown it out with a lot more noise than 133 sales people can make.
lurker, after taking the bath of my life on biotech since last April, I sold everything and moved into LABU, a 3X biotech leveraged ETF that tracks the NBI, and UWTI that tracks oil futures. I'm still holding ACAD June options - we'll see how that goes - so far terribly. I think RLYP may have found a bottom at 12.27.We'll know in the next couple of weeks I think. One solid scripts report will solidify the bottom and this can start moving up.