Now that people know Adam is a fraud, a cheat and a lackey for "the Street", hopefully he will be fired but if not, please stop giving this creature any credence by believing anything he says. He is a self serving fool that's has no other function but to destroy companies by spreading incorrect news and rumors that cause people to sell prematurely. His days as an analyst appear to be numbered. Cramer won't like all the negative press that's surrounding him and will most likely release him from his staff of reporters.
I called Keryx on Friday and spoke with the receptionist regarding the first AP article and explaining how incorrect it was and asked to speak with Investor relations then, but Amy was getting on a plane. When I called today the receptionist actually remembered me. She said, "oh yes, you called on Friday" and I told her that I was the first person to clarify to the AP lawyer Brian Barrett all of the inaccuracies in the article by Matt Perrone, which was subsequently corrected, albeit without pointing out significantly exactly what was corrected, and after significant damage had been done. She told me there was no one I could speak with, but after I told her about all of the legwork I did on Friday she transferred me to Amy. I asked her WHY there have been no PR's affirming the company's positive stance on Zerenex and refuting all of the misconceptions regarding the label "precaution". She said that generally just makes things worse, and she was aware of ALL of the negative articles, FBR statement, and the fact that NOTHING positive has been published. She did tell me that Ron will have much more prepared than his usual conference presentation tomorrow and it will be very upbeat and positive, along with providing clarification on the company's position post approval. I said the champagne must have tasted pretty sour with all of the misconception. misleading, misunderstandings, and manipulation. Apparently KERX was notified a few weeks ago about the name and hoped to have a new name approved by the approval, but that is still being determined. She did say to "hang in there" and was very receptive to all of the points I was making, including the lack of any positive press or articles on virtually all web outlets including Yahoo, Barron's, the New York Times, and AP. Expect a powerful presentation tomorrow by Ron and the team and I hope it perks the stock up a bit.
Sentiment: Strong Buy
In Japan, sales started in the last week of May 2014 when formulary was approved. Over the course of the year, there was steady and significant sales growth, from a couple of million in may and June to approximately $7.7 million in the most recent quarter and a total of more than $15.4 million in 2014 revenues. There are two important things to note: during that time period the yen declined against the dollar by more than 20%, so on a unit basis, sales were even stronger than the dollar numbers suggest; and the starting point, May 22, was when the drug was fully on formulary in Japan.. In the United States, we get formulary placement and reimbursement one carrier at a time. It is unrealistic to expect any meaningful sales until the vast majority of insurance carriers are covering the drug. Imagine if you were a doctor. Are you going to prescribe this to a patient whose carrier does not cover the drug? Are you going to even bother to check until most carriers are paying for the drug? The fact that we are seeing any sales at all at this point is interesting, but IT DOES NOT MEAN ANYTHING UNTIL THE DRUG IS COVERED. Kerx gave guidance that they would complete meetings with the 16 major carriers by the end of April. The thing we should be measuring at this point is not sales -- it is successful completion of these carrier meetings and formulary and coverage inclusion between now and end of April. Then starting in May, we will be on a level playing field with other drugs, and we then should definitely measure the sales trends and the sales growth. If they are anything like what we have seen in Japan from a market penetration perspective , we should be in very good shape. It is unfortunate that we have this period of exposure to the "failed launch" short story. But do not believe it or let a declining stock price convince you that this drug is not a powerful addition to the nephrologists' pharma arsenal. It is way too soon to make that call. Hang tough
05/22/2015 TRx: 249 NRx: 199
In comparison, last week's were:
05/15/2015 TRx: 214 NRx: 165
Solid week! Wonder how Memorial Day will impact this week's numbers that come out next Friday.
There has been a bit of probably unintentional mis-information on the board that should get clarified. I called the FDA for clarification. First, there is no PDUFA queue other than the natural queue that is set up by PDUFA date. Early releases are not done in order of the PDUFA date. There are target PDUFA dates and the FDA completes their review when they complete their review. Different divisions of the FDA have primary responsibility for review of drugs that fall within their division (ours is cardio/renal). So there are others that may have their PDUFA date after ours that may already have been approved or that may be approved before we hear anything. Second,If the PDUFA date falls on a weekend or business holiday, for purposes of measuring PDUFA target compliance, the date shifts to the next available business day. For our purposes, the FDA thinks of KERX's PDUFA date as Sept. 8. As for release of the approval/denial info, the FDA provides both the CRL or the approval to the company generally by fax before releasing the information publicly. They do NOT wait for a company press release before going public with the information but typically, they announce approvals on their website on the day following the approval. If you take a look on the FDA approval site you will see that the approval date is almost always the day before the posting date on the site. Finally , according to the officer I spoke with, with rare exceptions, they only announce approvals to companies and post information on their FDA website between the hours of 8;30 and 4:30 Monday through Friday.
Not that this all means anything -- by my reading that still means KERX could have received a fax today at 4:30 and be working on their press release for tomorrow. I actually do expect that we will hear something before next Monday. But either way,I thought it would be helpful to at least share the FDA answers to my questions -- always good to get it straight from the horse's mouth
VERY good week based on prior performance! As always, HUGE thank you to keystone.investments from the Amarin (AMRN) boards for getting these for us!
Auryxia: WE 03/13/2015
TR x: 151 (up from 99)
NR x: 134 (up from 89)
I've tried to refrain from posting and empowering the ignorance being spewed, but here's why I'm holding and/or adding to my position if/when I find the cash:
1. Risk/reward is heavily tipped in longs favor at current valuation at this point in time. $1.3B (current mkt cap) represents the value of cash plus the JT Torii opportunity alone, and you can see my previous posts for how I arrived at that calculation (~$77m/yr ebitda to KERX). I don't include R&D, SG&A, etc in that calculation because KERX could stop their selling/research efforts and still earn Japan royalties (i.e. looking at it from a margin of safety perspective). Anyway, US ESRD/NDD-CKD market, EU, and ROW represents upside and one of these has already come to fruition (US ESRD approval). If you take the most conservative estimate from our haters at FBR for US ESRD sales ($476m) and assume a 20% profit after costs/panion's take, you'd have an additional ~$95m in ebitda, bringing the total to $172m. Apply a 15x p/e and you're at ~$2.6B (~$28 stock). Again this doesn't include US market for NDD-CKD, EU, or ROW markets.
2. Large institutional holders like Baupost are in it for the long haul. If you're wondering if they're still holding, do some research on Baupost/Seth Klarman and their investment style/background and you will have no doubts. They have modeled this out with best/worst/base case scenarios and have deemed it a solid enough investment to take a large stake.
3. Big pharma has a patent cliff and dearth of new blockbuster drugs in the pipeline, hence why companies like ITMN and IDIX received such lofty valuations in buyouts. It appears that Ron has his sights set on launching the drug and proving the value to potential suitors before coming to terms on a buyout, but make no mistake that this is likely still the exit strategy here and could come at any time.
Patience will win this game. Stick with KERX and make money.
I can now state truthfully that the SEC has assigned a complaint number and an investigator to my written request concerning certain aspects of trading and media manipulation concerning Keryx stock. I do NOT know if they will find any of my concerns to be illegal or if the stock has been manipulated illegally. I do know someone will at least look at it. Every long on this Board should have written out a complaint to the SEC. If that has been done or is being done the weight of our concerns may merit a more in depth look. Together the ant can bring down many things march larger and supposedly more powerful.
Twenty stocks in the market have a proprietary metric called utilization perentage higher than 70. KERX is given a utilization percentage of 76.19 by Markit, the tenth highest in the market.
For the full story, google "Market rebound: Here are the names that may get short squeezed"
"According to Markit, a proprietary metric called utilization captures the ratio of securities in lending programs that are currently out on loan, expressed in percentage terms.
"A utilization above 70 is an indication that the majority of the supply of shares for short sellers has been exhausted. We have found that when utilization gets to these levels borrow costs typically increase, which makes staying with short positions more expensive," said analyst Andrew Laird of Markit.
"A stock with high utilization can be especially vulnerable to a short squeeze on the back of positive information, as high utilization is an indication of a crowding."
And it is this transaction level data that Markit claims provides an advantage in estimating short squeeze expectations much better when compared with traditional short interest data provided by exchanges on a bimonthly basis"
I have no doubt that Keryx gets approved very shortly. Some have said that all the approval is baked into the $16 price. I do not believe that. So many shorts and manipulators have prematurely held the actual price down. If we get approved just for patients using dialysis then the pop will be musts to $20. Approval with pre dialysis patients also go up to mid to high $20. Add usage for relief of iron deficiency anemia then you add GI doctors and the price rolls into the $30. Add. A buyout rumor and to any approval add 15-20%. Actual buy out offer and price could reach high $30 to $ $40. I know this is just speculation but all these new Vermin trying to free up shares indicates that shorts are beginning to weaken and covering is about to start in earnest. Just my humble and semi intelligent opinion but there will be some serious money earned by longs in the VERY near future. The Vermin could not get price below $16 which indicates strength of stock. I also love having Greenfield and Baupoint as fellow investors. Sort of reduces lots of stress. See all you fellow longs in NYC in front of Keryx headquarters shortly to celebrate our HARD earned new wealth.
First, I have to say that in the near future I will not be able to post as I will likely be privy to some non public information. The only aspect of keryx that I believe I am really capable of providing useful info about is the effectiveness and tolerability of auryxia. My view in that regard is more positive every day. Since I last posted, the dangers of iv iron in high doses have been born out by the new black box warning on ferraheme.. In my opinion, and I think most nephrologists would agree, the evidence against high doses of iv iron makes an effective oral treatment, that can be given in low frequent doses, more attractive. In addition, there was an abstract presented at the NKF spring meeting that analyzed the effects on anemia and iron stores in patients with non dialysis ckd given to pts for phosphorus binding and the results were very good. ...to me the sales data are irrelevant at this point. In the US it is just going to take time to be more widely adopted and I am not sure what to make of Japan's data but I would expect continued slow but steady growth. The use of auryxia in the non dial dependent patients, if and when approved for the treatment of anemia, will result in exponential growth very likely. Good luck to you and all the longs.
He was and is a class act. He knows that his expertise is in the drug development and not commercialization. That is why he brought Madison and company onto the team. He built KERX on a very lean budget and advanced the company's prospects through the regulatory processes from near bankruptcy to the cusp of commercialization. I am impressed that he has seen what is in the best interests of shareholders as this company moves into commercialization and is prepared to step aside to let someone with more directly relevant expertise lead the way. Despite last year's relatively muted stock performance, Ron has shepherded the stock from literally cents on the dollar to a billion plus enterprise with a potential blockbuster compound approved and advancing for other indications. In my mind, for long term holders, we all owe him a debt of gratitude and should look forward as Greg brings this company to its next meaningful iteration..
One thing I would point out. All you folks who are attributing this move to Baupost should think twice. Baupost's filings state that they are not seeking to influence management or take any active role in the management of the company. It is partially because of this hands off role that Baupost is able to avoid more frequent filings when they change their kERX stake. Rest assured, the company definitely gave Baupost a courtesy call about the news and maybe even solicited assurance that this move would not change their view of the company.. But I am certain that Baupost did not negotiate this transition. Baupost's exit comes from a sale of the company; and that sale will happen at the highest price when Auryxia is showing commercial success and the drug is ripe for CKD approval.
I personally wish Ron a ton of luck and thank him for the wealth he has created for me and my family. Now let's see what Greg can accomplish getting this thing blasting off the launchpad!
1. Is an effective phosphate binder
2. Increased ferritin (Renvela/Phoslo +2% … Auryxia + 51% (p=.0001))
3. Increased TSAT (Renvela/Phoslo -3% … Auryxia + 26% (p=.0001))
4. Lowers Iron-IVs (= $hundreds of millions saved / year)
5. Lowers ESA’s (= $hundreds of millions saved / year)
6. Causes higher hemoglobin (Renvela/Phoslo -0.6(g/dL … Auryxia +0.2 g/dL (p = .0105)
7. Causes lower FGF-23 (Placebo +11% … Auryxia -37% (p = .017)
8. Has fewer side effects
9. Results in fewer hospitalizations (= $thousands saved per member per year, not to mention what this means to patients)
10. Saves veins – “I think another important point for those patients with CKD who eventually progress is simply avoiding intravenous cannulations and hospitalizations and infusion center admissions are not only cost savings but they are vein savings. Meaning that avoiding intravenous therapy of any type is a priority for patients who are ultimately progressing toward end-stage renal disease care to preserve their veins for arteriovenous distally.” -- Dr. Glenn Chowtow - Chief, Division of Nephrology and Professor of Medicine at Stanford University School of Medicine, 11/5/13 conference call.
11. U.S, Phosphate Binder sales growing @ 11-12% / year (= doubling in 6.3 years)
All of this is documented in the 1/28/13 PR, the 11/5/13 CC transcript, and the late 2014 conference calls.
Sentiment: Strong Buy
I think that sfgrrridoc did a good job of pointing out the value of zerenex in the treatment of iron deficiency anemia in patients with end stage renal disease. I would like to explain how this would work in practical situations. If a patient is already on a phosphate binder (which is the most common scenario) and the doctor wishes to replace the current binder with zerenex, he or she would likely discontinue or reduce the dose of the current binder and start a low dose of zerenex. They should also consider stopping iv iron if the iron stores are adequate. Phosphorus levels and iron saturation would dictate the titration of the dose of zerenex. If phosphorus levels are in target but iron stores remain low, it is best to give some iv iron along with the zerenex. If phosphotus levels are high but iron stores are adequate or high, an additional phosphate binder may need to be used....To say that zerenex causes iron overload is to assume that the nephrologist will just continue to give the drug regardless of the iron studies and phosphorus levels. That is tantamount to assuming that an antihypertensive will cause symptomatic low blood pressure. Obviously, in that situation, any competent doctor would lower the dose of the antihypertensive drug.
So the question is, using this reasoning, will there be enough zerenex used to make investing in the company that makes this drug a good investment. Based on all of the data available about iron deficiency and hyperphosphatemia in dialysis patients and the current market cap of the company I believe it is a very good investment even just considering the use in dialysis patients. If zerenex is used in non dialysis ckd patients to any extent it becomes better and if you believe, as I do, that the drug may ultimately be used in patients without kidney disease that have iron deficieny it becomes better still.