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 cant help me this is incredible.
It has begun as Greg Madison has vaticinared in many conferences .
Many formularies have switched recently from Tier 4 or 5 to Tier 3
AURYXIA IS NOW A PREFERRED DRUG
For all those shorting Keryx... THINK ABOUT IT
Prevea360 Drug Formulary Changes
Preferred 3 Tier Formulary
05/01/2015 AURYXIA TAB A Add to Tier 3
Excellus Blue Shield/blue Cross
Brand / Tier
AURYXIA 3 QL
calcium acetate 1
FOSRENOL 3 QL
QL = Quantity Limit applies
L.A. Care Covered Direct Formulary
Brand / Tier
AURYXIA TAB - 3
Horizon Blue Cross Blue Shield
AURYXIA - 3
DAKOTACARE Drug Formulary
PHOSPHATE BINDER AGENTS
lanthanum Tier 2 FOSRENOL
calcium acetate Tier 3 PHOSLO
ferric citrate Tier 3 AURYXIA
Sentiment: Strong Buy
Thank you to keystone.investments from the AMRN boards for getting these for us again! Also, as an FYI, I will be traveling next Friday and might not be able to post the scripts, so hopefully someone else can access them. Looks like this was a very solid week overall!
07/24/2015 234 160
Last week for comparison:
07/17/2015 199 127
JUNE 01, 2015
Pharma companies have long struggled to pen compelling value stories for their products. Could they learn a thing or two from the case Keryx Pharmaceuticals built for its renal drug Auryxia? James Chase reports
Download: Payer Pressure—Value-Able?.pdf
In November 2012 a New York Rangers superfan named Molly Heines successfully bid $66,000 at charity auction for a game-worn mask belonging to goaltender Henrik Lundqvist. How could a used mask possibly be worth that much money? The explanation, of course, is the same one the scribe Publilius Syrus offered to the world more than 2,000 years ago: because that's how much Heines was willing to pay for it.
In the pharma industry, the concept of value can be even more perplexing. For starters, it can mean something entirely different to each stakeholder, depending on the disease state and the market. What's more, it is measured using a bewildering mix of units—dollars, mortality, dosing, side effects, convenience and market share, to name but a few.
Nevertheless, as the healthcare landscape continues to change, the need for pharma to add, demonstrate and communicate value has never been greater. And this is where it gets a little challenging. This is an industry built on constants, not variables, one where tangibles eliminate surprises and where every action is quantifiable. But if developing and selling medicines is an exact science, the concept of value is anything but.
“For pharma and biotech companies today, value is no longer an equation but a multidimensional appeal to a range of stakeholders, who are more discerning than ever,” says Rita Glaze, EVP, director, US market access at Edelman. “The opportunity to look at value through a shared lens is exciting, but the challenge is daunting. The industry is grappling with finding a shared definition of value across stakeholders while delivering to investors and planning for investments in future innovation cycles.”
For his part, Greg Madison, president and CEO at Keryx Biopharmaceuticals, feels the landscape has changed significantly. “For years innovation was defined by big pharma as brand extensions and maybe subtle differences as a way to manage life cycles,” he explains. “Clearly, these days you can't get away with a me-too approach and expect to get the reimbursement that perhaps 10 years ago you could. Proving your value, in addition to the fact that [a drug] works and that it's safe, is critical.”
Although it might be a little harsh to label Madison as one of the aforementioned “grapplers,” he has certainly had his hands full since he took the reins of the Boston-based biotech in February—just weeks after its debut product Auryxia hit the market. “We didn't have time to do premarket development,” he says with half a smile. “We didn't even get the name Auryxia until November. Then we launched two months later.”
The fun, almost cartoonish scene he paints of Auryxia's on-the-fly scramble to market belies a truer picture—one of the smart, strategic course Madison is plotting to drive and demonstrate the value of this breakthrough pill across key constituents.
Approved in September 2014, Auryxia (ferric citrate) is a phosphate binder for dialysis patients with chronic kidney disease. While there are three or four existing competitors, Auryxia is the first and only absorbable-iron-based phosphate binder. (Dialysis patients are iron-deficient and typically receive intravenous iron or other products at dialysis to help manage their anemia.)
Patients, payers and providers
Many of these drugs come with risks of adverse events. But since Auryxia is absorbable-iron-based, patients require fewer injectables. And this, essentially, is what drives the product's true value across all stakeholders.
“Value, first and foremost, needs to go to the patient,” Madison explains. “It doesn't necessarily have to be a mortality benefit, but it's got to bring value to the patient in a significant way that makes his or her life better or more sustainable or durable overall.”
Auryxia creates value for the patient by, of course, limiting exposure to potentially harmful injectables. However, Madison points out that it doesn't make sense to communicate this value message directly to the dialysis population.
“It's much more important to go to the dialysis clinics themselves,” he says. “The doctor, the dietician, the nurses and the social worker—those are the four to whom you really need to drive the value message. The dietician sees patients maybe three days a week when they are in the dialysis chair, so they're the ones that get to know them.”
The value message to the payer is based on robust clinical trials data. In the case of Auryxia, it offered a compelling and persuasive story on two different levels. First, there was the reduction in the use of supplementary medications (such as IV iron and ESAs) during dialysis—not to mention the cost savings associated with this. Second, there was a 24% reduction in hospitalization for patients taking Auryxia.
Amy Sullivan, VP corporate development and public affairs at Keryx, notes that certain payers then took the clinical trial results and cross-referenced them with their own databanks to project potential savings. “One group calculated they would save about $1,000 per patient per year. Another factored in the hospitalization and found they would save $2,000 to $4,000 per patient per year. It's quite significant,” she says.
Sullivan adds that payers have generally been on board with Auryxia's pricing. “We entered at a price point that was, at the time, just a bit higher than the market leader,” she says. “And then the market leader took two increases, so we're now priced at a discount. So [payers feel] we've priced it responsibly, which is nice to hear.”
Healthcare providers, of course, are the owners and operators of the dialysis centers themselves. From a reimbursement landscape, the dialysis providers operate what is known as a bundle payment system, whereby they receive one payment each time a patient sits in the dialysis chair. That covers the dialysis itself as well as any injectables they administer, like IV iron or ESAs.
“They try to run a profitable business,” says Madison. “So from their perspective, we have a drug now that [reduces the need for the injectables]. It's a financial advantage for the dialysis providers as well … We've got a unique product here that aligns really nicely on the clinical side and really drives value across all the different stakeholders in this marketplace.”
Madison says the payers really represent the keys to the success of Auryxia. His objective by the end of the third quarter is to accumulate enough formulary wins to provide unrestricted access to 80% of the dialysis population.
To be continued
But the story doesn't end there. A Phase-III program is about to get under way for a new indication for Auryxia. Currently 70% enrolled, the trial will focus this time on iron-deficiency anemia (IDA) in the pre-dialysis population. “It's another unmet medical need,” Madison explains. “There are about 1.5 million patients with IDA and, really, the vast majority of those are not being treated today. The oral irons are not well tolerated and they don't work really well, and the only other option is the injectable iron that we already know has the potential for side effects and other challenges for the patient.”
If the trial is successful, the new indication could spawn another significant value story for Keryx. “The first year of dialysis produces the highest rates for morbidity, mortality and cost,” Madison continues. “When patients first show up for dialysis, they have low hemoglobin, low iron, high phosphorus levels and so on. They're in bad shape. Everything tries to get fixed at once.”
However, Madison believes Auryxia could provide a treatment option for patients in pre-dialysis to manage their iron stores and anemia. When they get to dialysis, then, they should be in a better physical state and might not need an injectable.
“It intuitively makes sense to fix all those things before they get there,” he says. “We just have to up the proof of that with data. But if that turns out to be the case, then you're driving incredible value across patients themselves, providers and insurance companies.”
Sullivan feels that there are lots of advantages to Keryx being a small company, particularly in development. “Small companies do things so much quicker and more efficiently than the big companies,” she notes. However, she has found the opposite experience to be true when negotiating with payers. “What we realized as a small, one-product company is that you don't have a lot of leverage in terms of timing. Bigger companies definitely have greater leverage in terms of importance on [the payer's] timetable. It's a double-edged sword.”
Madison agrees. “I'd rather be small. Every time stuff comes up, you can react, move quickly and go. But you just don't have the leverage behind negotiations, the ability to force timing. That's the harsh reality. You can't just go, ‘Hey, we're Pfizer, we have all this other stuff. We demand your attention right now.' ”
Another interesting piece in the value puzzle is the trend for companies to promote themselves as experts and leaders in their respective categories instead of marketing only their products. Keryx is fully on board with this approach and has already sponsored a number of community events.
“At this point, there really isn't a leader in the renal states because the big players like Amgen and Genzyme have backed away a little bit,” says Sullivan. “But our company really is focused on—and devoted to—bringing innovation to renal patients. We think it's been an underserved patient population for a number of years. So at the same time we are building the Auryxia brand, we're trying to do things with the corporate brand as well.”
THE VALUE-ADDED MESSAGE
It's one thing for a small specialty company to demonstrate value with a single breakthrough product. It's quite another for a established pharma giant to attempt to do the same with an entire stable of products. Enter AstraZeneca and its respiratory portfolio.
AZ has been in the respiratory game for four decades, but a spate of acquisitions in the past couple of years has underlined its intent to become the category leader. “We are dedicated to eliminating the burden of respiratory disease for current and future patients,” says Michael Austwick, executive director, US Respiratory Franchise at AZ. “Our strategy is to become an industry leader in -innovative inhaled and targeted therapies for asthma, chronic obstructive pulmonary disease and idiopathic pulmonary fibrosis by offering a diverse portfolio of respiratory products to meet the needs of patients across all phases of disease severity.”
The value message of the portfolio combines AZ's deep expertise in respiratory with the diversity of solutions available to patients. It also emphasizes the company's innovative technologies and products, both those currently available and those under development.
Adding to mainstay stablemates Symbicort and Pulmicort, AZ -recently acquired the rights to Actavis's branded respiratory business in the US and Canada. In the wake of the deal, AZ now controls the development and commercialization of Tudorza Pressair and Daliresp. The company is also developing a line of inhalation -therapies based on the Pearl products for COPD and asthma.
Meanwhile, two lead investigational biologic agents from AZ's MedImmune global
Sentiment: Strong Buy
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.
darrell franklin @VexImperfect 13h13 hours ago
Seems that the switch from renvela to auryxia an improvement. Phosphorus lvls lowest they've been since 2012. Less heat stress #stuckhere
Sentiment: Strong Buy
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.
Baupost accumulated upwards to 35% of IDIX stock before its buyout by MRK. On the day before the buyout announcement, IDIX was just another beat down stock like KERX is today and listed for $7.23 a share. Merck's buyout offer was for $24.50.
Baupost started accumulating KERX stock in the first quarter of 2014, increasing its stake every quarter up to and including the first quarter 2015, to where it now owns almost 22% of oustanding KERX stock. Based upon the average stock price for each of those quarters and Baupost's reported holding increases, I estimate his cost basis in almost 22 million shares to be about $14.
Two observations: One, substantial additional accumulation by Baupost of KERX is more likely than not at these low price levels. Two, a buyout price in the mid twenties for KERX should be a floor, with much higher prices likely. Why? While IDIX was just a promising clinical stage company in the Hep C space and was crowded with high powered competitors like Gilead, AbbVie and Bristol Myers Squibb, KERX has no competition in the renal space for an iron reducing, phosphate drug that is FDA approved drug with an expanded label likely that will triple its existing market.
Have a great weekend!
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.
Q1 RIONA 936 mYen (7,57 mDollar)
Q2 RIONA 1285 mYen (10,39 mDollar)
Estimates Q2 Frankie 1120 mYen
2015 Torri 4620 mYen (1155/Quarter) = 37,34 mDollar (9,34 mDollar)
Probably Torri will raise the expections for RIONA. WHAT A GREAT DAY
Shorts are in big trouble
Sentiment: Strong Buy