Relypsa Inc (RLYP)

[ClearlyStocks]

Nice gap up already

[Panzer]

Shorts covering like crazy no doubt

[Panzer]

Panzer loaded in RLYP. Ez money

[Mitshu35]

Relypsa Inc. (NASDAQ:RLYP) has renewed respect among analysts now that the Food and Drug Administration (FDA) has unexpectedly delayed approval of AstraZeneca’s (ADR) (NYSE:AZN) competing hyperkalemia treatment, ZS-9. On Friday, Wedbush reaffirmed its Outperform rating and price target of $51 on Relypsa, citing improving investor sentiment. The stock closed at $19.96 on Friday.

Relypsa markets a hyperkalemia drug called Veltassa - the first treatment for the disease approved in over 50 years. Hyperkalemia is characterized by dangerously high potassium levels in the bloodstream and is commonly found in patients suffering from underlying conditions of chronic kidney disease (CKD) or heart failure (HF). Some drugs, including RAAS inhibitors like ACE inhibitors or ARBs, which are often prescribed to CKD or HF patients, can cause hyperkalemia as a side-effect. The condition results in abnormal heart rhythms and can be potentially life-threatening. Veltassa was approved by the FDA in October 2015 as an alternative to an age-old medicine called Kayexalate, which has been commonly linked with adverse events including intestinal cell death, gastrointestinal bleeding, and constipation in the past. Veltassa itself carried FDA’s strictest black-box warning which cited its tendency to interact adversely with other oral drugs if taken six hours apart, stating that it is “not appropriate for rapid correction of severe hyperkalemia because lowering of serum potassium may take hours to days.” The drug’s launch was disappointing at best, with physicians hesitant in prescribing a new, risky drug that would require changing of “the habit of a lifetime,” as put by Relypsa CEO John Orwin in the company’s first-quarter earnings call.

Late on May 26, however, Relypsa got a major boost when AstraZeneca announced that its closely-watched hyperkalemia alternative, ZS-9, had been rejected by the FDA. The agency issued a complete response letter (CRL) to the drug-maker, citing need for fixing some manufacturing issues although no additional clinical trials were asked for. Analysts believe the snag would delay ZS-9’s launch until at least 2017, which is great news for Veltassa because ZS-9 was expected to not carry FDA’s boxed warning, making it a possibly better alternative drug.


Wedbush analyst Liana Moussatos said in a recent research note that ZS-9’s delay will give Relypsa more than a year to establish Veltassa as the preferred chronic treatment for hyperkalemia. “Since then we have observed increasing investor interest in Veltassa and RLYP stock value has increased,” she added. Note that the addressable hyperkalemia market is huge; about 3 million patients suffer from the condition in the US. Veltassa is priced at about $595 for a 30-day supply or over $7,000-a-year per patient. The chronic treatment can result in a staggering market size of $21 billion.

She further said that the bear arguments against Veltassa, which have been making rounds since ZS-9 was slapped with a CRL, are starting to sound “hollow.” “Since the ZS-9 CRL we have heard bear arguments about Veltassa having many adverse events reported to the FDA; however, the FDA has not issued any warnings. We believe this is due to adverse events being common in CKD and heart failure patients and not being considered to be drug related,” she commented. “Veltassa is a nonabsorbed bead-shaped polymer that binds potassium and releases calcium. The most common adverse event in clinical trials was constipation. By contrast, we anticipate drug-related adverse events (especially sodium related hypertension and edema) to increase with longer-term use of ZS-9 due to its mechanism which elevates sodium in these universally sodium restricted CKD and heart failure patients.”


The analyst further dispelled concerns that the specialty pharmacy hub (Veltassa Konnect) for prescribing Veltassa may be inconvenient for doctors due to hassles like extra paperwork, compared to the expected retail prescribing of ZS-9. “We understand that reimbursement hurdles are likely to be the same for ZS-9 as for Veltassa and that while the specialty pharmacy hub (Veltassa Konnect) provides patient assistance when payors require prior authorization for initial prescriptions, retail patients have no such assistance when a retail pharmacist tells them their prescription was rejected by their insurance company. Consequently, we see the potential for a higher rate of unfilled prescriptions for ZS-9, if approved,” she said.

Ms. Moussatos also believes there is possibility that Relypsa will be able to get FDA’s boxed warning removed from Veltassa’s label by the end of this year. The company recently applied for a label change with the FDA based on new Phase 1 trial data of Veltassa from drug-drug interaction studies. “Relypsa recently announced submission of a sNDA to the FDA with data from the Phase 1 drug-drug interaction (DDI) study that showed no reduction in activity when dosing of Veltassa and certain drugs commonly prescribed for CKD and heart failure were separated by three hours and no clinically meaningful interaction for many drugs when co-administered with Veltassa. Given these results, we believe Relypsa is likely to be successful in requesting the FDA remove the black box warning, reduce the drugdrug separation time from 6 hours to 3 hours and having the DDI results included in a standard section of the package insert,” the analyst stated.

Note that many physicians are in the process of changing their age-old practice of using traditional intermittent hyperkalemia treatment to chronic add-on therapy. Relypsa’s commercial chief Scott Garland said in the last earnings call that a vast majority of nephrologists and cardiologists, some 73-97%, are aware of Veltassa and the drug’s script trend will increase gradually but surely. The latest events suggest a much faster pickup. Mizuho’s Irina Rivkind Koffler has also been optimistic about Veltassa’s future prospects in a research note. "Veltassa has demonstrated a number of cardio-renal protective properties at recent medical conferences like its ability to also lower blood pressure, sodium, and aldosterone levels that we think may be attractive to buyers. Additionally, with uncertainty around the ZS-9 launch Veltassa could have scarcity value. Mgmt also indicated that some payers are more receptive to coverage since they were previously waiting for ZS-9 approval to make a decision,” she said.

Veltassa is expected to pull in about $1.4 billion in annual sales eventually, making Relypsa an attractive takeover target. Ms. Koffler also stroked the renewed possibility of Relypsa acquisition by larger players with improved Veltassa prospects. Sanofi SA, which is already partnering with Relypsa for Veltassa’s US marketing, AstraZeneca, which acquired ZS-9 along with its maker ZS Pharma for $2.7 billion in November, Pfizer, and Biogen have been cited as possible acquirers.

[ClearlyStocks]

Filled $20s

[ClearlyStocks]

$RLYP $20.60s I'm long. 45% is short. Should be a nice short covering squeeze.

[Mitshu35]

BTIG affirms Relypsa (Nasdaq: RLYP) at Buy with a price target of $35 following recent conversations with management.

Analyst Timothy Chiang commented, We recently hosted a Q&A session with Relypsa’s senior management team to discuss a number of key items including the recent CRL received by AstraZeneca (NYSE: AZN) on ZS-9 and what impact that will have on its Veltassa (for the treatment of hyperkalemia). In addition, we discussed other items including the current reimbursement environment for Veltassa, as well as what the key inflection points might be.

In sum, while payor headwinds are likely to remain, we think it may now be less of challenge to gain formulary access, especially now that its competitor (ZS-9) has been delayed.

We expect Veltassa prescription trends to continue to rise steadily in 2016, with a pick up occurring in the second half as insurance coverage is attained. In addition, we expect an FDA decision within the next 4-6 months on the Co.’s proposed labeling changes (to narrow the dosing separation window for Veltassa with other medications). Overall, we remain positive on RLYP shares and believe Veltassa is well-positioned to generate meaningful sales longer term.

[Mitshu35]

I am as well, but maybe just a reflection of the currently out-of-favor biotech sector. I am not sure that ZS-9 will ever get approved....I think AZN can address the CRL manufacturing issues but may have a bigger hurdle to get over once the FDA reviews on the trial data (or lack thereof). Future for RLYP seems quite strong now (was good before the CRL but even better now). Just need to see shorts cover so the stock can really move up in earnest now.

I think there were 3 analysts who either reiterated or upgraded their price targets over the weekend...a holiday weekend at that. Looks like a lot of eyes/attention on RLYP now. Picked up quite a few more shares this morning - market cap is way too low now given their prospects IMO.

[value1008]

Thanks for that-- i'm surprised the Citi analyst still has such a relatively low PT of $25 for RLYP.

[Mitshu35]

Link to Citi comments - worth reading:

https://pbs.twimg.com/media/Cjdj4neW0AAlQP-.jpg

[nsomniyak]

That reads as though it is old - what date was that from?

[Mitshu35]

Relypsa Inc (RLYP.O), a U.S. developer of treatments for high blood potassium, is exploring a sale following overtures from a number of potential buyers, according to several people familiar with the matter.

Relypsa shares jumped as much as 68 percent on the news on Thursday, giving it a market capitalization of close to $1 billion. The stock was up 50 percent at $21.78 percent at mid-afternoon. Relypsa is working with investment bank Centerview Partners Holdings LLC to review offers, the people said this week. The discussions are in their early stages and may not lead to a sale, said the sources, who asked not to be identified because the talks are private.

Relypsa declined to comment. Centerview did not respond to a request for comment.

Relypsa and its primary competitor, ZS Pharma, are racing to develop treatments for hyperkalemia, or excessive potassium in the blood. Some analysts estimate the market to be worth about $6 billion.

Interest in Relypsa has picked up in recent months after the $2.7 billion sale of ZS Pharma to AstraZeneca Plc (AZN.L), the people said. Several companies that unsuccessfully bid for ZS Pharma have reached out to Relypsa, the sources said.

Relypsa, based in Redwood City, California, received U.S. Food and Drug Administration approval in October for the sale of its primary hyperkalemia drug Veltessa. ZS Pharma's rival drug, ZS-9, is awaiting FDA approval.

The sources said they expect ZS-9 to outperform Veltessa over time.

Relypsa's stock has been caught in the recent biotech sell-off, dropping from more than $30 in August to around $14 early Thursday.

Merck & Co Inc (MRK.N), Pfizer Inc (PFE.N) and Biogen Inc (BIIB.O) have all expressed interest in acquiring undervalued biotechnology companies.

Unlike some of its biotech peers, Relypsa has strong finances, with nearly $300 million of cash and near-term investments as of September.

About 17 percent of Relypsa's stock is owned by its largest investor, investment firm OrbiMed Advisors LLC.

[Mitshu35]

we expect pharma interest in owning RLYP to materially accelerate - Citi comments after zs9 CRL

[$$$eeker]

$RLYP Maybe but I don't think so. It was up over $24 premarket.

[warrentt]

People are just taking profit. But it ran up close to $21 early today. I will add long term position when the dust settle again.

[warrentt]

You are good.

[rahrah]

can't believe AZN didn't take a hit on the news?

[$$$eeker]

$RLYP shorts working on this one.

[Warchest]

we have a flipper today ~

[bullrider2]

We're up more than 30% today. RLYP could see $30 when the market open.

[H2R]

... and RLYP PPS action should be 'interesting' today :)

Good luck to Longs :)

[H2R]

ZS-9 Gets a CRL!

https://www.astrazeneca.com/media-centre/press-releases/2016/astrazeneca-receives-complete-response-letter-from-us-fda-for-sodium-zirconium-cyclosilicate-zs-9-for-oral-suspension-for-treatment-of-hyperkalaemia-27052016.html

27 May 2016

AstraZeneca today announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for sodium zirconium cyclosilicate (ZS-9), the investigational medicine being developed for the treatment of hyperkalaemia (high potassium level in the blood serum) by ZS Pharma, a wholly-owned subsidiary of AstraZeneca.

The CRL refers to observations arising from a pre-approval manufacturing inspection. The FDA also acknowledged receipt of recently-submitted data which it has yet to review. The CRL does not require the generation of new clinical data. AstraZeneca and ZS Pharma are evaluating the content of the CRL and will work closely with the FDA to determine the appropriate next steps for the NDA.

AstraZeneca remains committed to the development of sodium zirconium cyclosilicate as a treatment option for patients with hyperkalaemia. Interactions are ongoing with other health authorities in the European Union and Australia, where sodium zirconium cyclosilicate is currently under separate regulatory review.

[salgovernale69]

No news, which means likely CRL, which will be PR'ed at 2 am EST, 8 am UK time.

[H2R]

RLYP PPS up AH, but I don't see the ZS-9 news

Anyone has a link on the FDA decision for ZS-9?

[H2R]

ZS-9 PDUFA Date is Upon Us

Let's see what happens on May 26 with ZS 9. This could clarify the market and could potentially influence the medium term outlook for RLYP, either in terms of pure market share (most of it? half? less?) or in terms of potential acquisition.

The pundits and analysts will have a field day. RLYP longs could benefit from it. Hopefully :)

GLTA Longs!

[Mitshu35]

This was from December, I didn't realize before posting. Sorry for any confusion, but I believe the BO price target is in line and consistent with others I have seen. Market cap is currently way too low!

[Mike Larry]

Do you have a link?

[Mitshu35]

Published yesterday:

Cantor Fitzgerald reaffirmed their buy rating on shares of Relypsa Inc (NASDAQ:RLYP) in a research report report published on Monday morning. Cantor Fitzgerald currently has a $41.00 target price on the stock.

RLYP has been the subject of several other reports. Wedbush lowered their price objective on Relypsa from $52.00 to $51.00 and set an outperform rating for the company in a research report on Monday, May 9th. Citigroup Inc. lowered their price objective on Relypsa from $45.00 to $38.00 in a research report on Friday, February 19th. Raymond James initiated coverage on Relypsa in a research report on Friday, April 1st. They set a market perform rating for the company. BTIG Research reaffirmed a buy rating and set a $45.00 price objective on shares of Relypsa in a research report on Tuesday, January 26th. Finally, Cowen and Company reaffirmed a buy rating on shares of Relypsa in a research report on Sunday, April 17th. Two research analysts have rated the stock with a sell rating, two have issued a hold rating, twelve have assigned a buy rating and one has issued a strong buy rating to the company. The stock presently has a consensus rating of Buy and an average price target of $36.36.

Relypsa (NASDAQ:RLYP) opened at 14.14 on Monday. Relypsa has a 12 month low of $10.26 and a 12 month high of $37.45. The company’s market cap is $632.72 million. The firm’s 50-day moving average is $17.00 and its 200-day moving average is $19.12.

Relypsa (NASDAQ:RLYP) last released its quarterly earnings data on Wednesday, May 4th. The company reported ($1.26) earnings per share (EPS) for the quarter, topping the Thomson Reuters’ consensus estimate of ($1.46) by $0.20. The business had revenue of $12.40 million for the quarter, compared to analyst estimates of $6.88 million. During the same period in the prior year, the company posted ($0.78) earnings per share. On average, analysts anticipate that Relypsa will post ($5.91) EPS for the current fiscal year.

In other Relypsa news, CFO Kristine M. Ball bought 7,000 shares of the business’s stock in a transaction dated Wednesday, March 16th. The stock was acquired at an average cost of $12.15 per share, with a total value of $85,050.00. Following the purchase, the chief financial officer now owns 28,290 shares in the company, valued at approximately $343,723.50. The transaction was disclosed in a document filed with the SEC, which is accessible through the SEC website. Also, Director Thomas J. Schuetz bought 30,000 shares of the business’s stock in a transaction dated Tuesday, March 15th. The shares were acquired at an average cost of $13.39 per share, with a total value of $401,700.00. Following the completion of the purchase, the director now owns 33,962 shares in the company, valued at approximately $454,751.18.

Several institutional investors have modified their holdings of the company. Schwab Charles Investment Management Inc. increased its position in shares of Relypsa by 21.4% in the fourth quarter. Schwab Charles Investment Management Inc. now owns 106,548 shares of the company’s stock worth $3,020,000 after buying an additional 18,770 shares during the period. Wells Fargo & Company MN increased its position in Relypsa by 2,235.5% in the fourth quarter. Wells Fargo & Company MN now owns 236,987 shares of the company’s stock valued at $6,715,000 after buying an additional 226,840 shares during the last quarter. California Public Employees Retirement System purchased a new position in Relypsa during the fourth quarter valued at $3,826,000. Jennison Associates increased its position in Relypsa by 0.5% in the third quarter. Jennison Associates now owns 303,767 shares of the company’s stock valued at $5,623,000 after buying an additional 1,567 shares during the last quarter. Finally, Convector Capital Management LP purchased a new position in Relypsa during the fourth quarter valued at $1,326,000.

Relypsa, Inc is a biopharmaceutical company. The Company is focused on the discovery, development and commercialization of polymer-based drugs to treat conditions that are often overlooked and undertreated, but that can have a serious impact on patients’ lives and even be life-threatening. The Company’s first drug candidate is Veltassa (NASDAQ:RLYP) for oral suspension, or Veltassa, for the treatment of hyperkalemia.

[H2R]

SmithOnStock: Two 2016 scenarios

Lots of variable to analyze, plus of course May 26...

Here is a quick summary from the SoS article:

The 2016 Working Scenario:

Using those estimates I can then project quarterly sales rates and annualized sales rates at the end of each quarter as is shown in the following table. This set of assumptions results in a full year sales estimate of $16.3 million and the annualized run rate at the end of 2016 would be $35.0 million

The 2016 Optimistic Scenario:

This optimistic scenario would result in full year sales of $40.8 million and an annualized run rate of $153.9 million as of December 2016.

[Mitshu35]

As Veltassa Continues To Grow, BTIG Still Buying Relypsa

Jim Swanson. Bezinga Staff Writer
May 17, 2016 8:12am

Relypsa Inc
RLYP has released monthly Veltassa prescription trends for April, with paid prescriptions rising to 928 in the fourth full month following the launch of the drug and the company having dispensed 1,216 starter packs.

BTIG’s Timothy Chiang maintains a Buy rating on the company, with a price target of $35.

Veltassa Growing

“We believe the launch of Veltassa will continue to show gradual increases in paid monthly prescriptions, with more meaningful increases expected in 2H16,” Chiang stated.

The analyst maintains the CY16, CY17 and CY18 Veltassa sales forecasts at $26.5 million, $84.5 million and $203 million, respectively.

The company is expected to see loss per share during CY16–CY18, turning breakeven in 2019 with an estimated EPS of $2.02 in 2020.

“Post the Co.’s recent debt financing, cash and short term investments totalled ~$336 million as of the end of 1Q, which we think will be sufficient to get the Co. through this year and 1H17,” Chiang mentioned.

Competition

Chiang expects the FDA approval decision for AstraZeneca plc (ADR)
AZN ZS-9 to come in by May 26. This product could be a potential competitor for Veltassa.

“While we expect Relypsa shares to remain volatile in front of this decision, we believe there is ample room for two hyperkalemia treatments, as our Veltassa sales forecasts reflect just low-to-mid single digit penetration in an addressable patient population of ~3 million patients,” the analyst added.

[Mitshu35]

Relypsa's Veltassa Continues An Upward Trajectory Among Nephrologists But Familiarity And Use Is More Muted Among Cardiologists

ZUG, Switzerland, May 18, 2016 /PRNewswire/ -- According to the most recent monthly nephrology survey fielded at the end of April (n=112), the user base for Veltassa continues to expand with more than half of the nephrologists in trial mode. Current users have high satisfaction levels and physicians consistently report that a healthy number of their hyperkalemic patients are Veltassa candidates across all treatment settings. Overall the majority of nephrologists expect to increase their use of Veltassa in the near term and very few nephrologists do not see a role for Veltassa in their practice.

The six-hour dose separation requirement is noted as the leading disadvantage with nearly 90% of the respondents indicating that this does somewhat limit their use of Veltassa. This is largely consistent with feedback from cardiologists (n=93), although familiarity with Veltassa and trial rates are significantly lower among cardiologists compared to nephrologists. Both specialists agree that Veltassa is most beneficial as a long term therapy as it allows for the extended the use of ACE/ARB therapy in CKD/CHF patients.

European physicians may soon have access to Veltassa as well. Vifor Fresenius Medical Care Renal Pharma submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for Veltassa in late April. According to Market Dynamix: Hyperkalemia in the EU5, over 300 cardiologists and nephrologists reported that the unmet need for a new hyperkalemia treatment is high. Cardiologists estimate that 40% of their patients with CHF and CKD would be candidates for chronic treatment, the highest among various patient types prone to hyperkalemia. There are significant differences between the five major countries in terms of potassium resin use. Similar to the US market, nephrologists were significantly more familiar with pipeline agents compared to their cardiology counterparts.

May could introduce more paradigm shifting with the potential approval of AstraZeneca's ZS-9. Familiarity with ZS-9 has reached an all-time high among nephrologists with about 40% reporting high familiarity with the drug.

[Mitshu35]

Wedbush analyst Liana Moussatos reiterated an Outperform rating and $51 price target on Relypsa, Inc. (NASDAQ: RLYP), saying the April prescriptions reflect physicians testing Veltassa prior to widespread change of practice. Moussatos also said with the FDA decision for potentially approving ZS-9 as an alternative potassium binder, they anticipate RLYP shares could appreciate due to decreased competition risk if ZS-9's label mentions adverse events such as edema and hypertension.

As expected, April launch metrics point to a gradual launch as physicians test Veltassa before wide adoption. In April, 1,216 patients received a free starter supply of Veltassa, 928 outpatient retail prescriptions were filled, and 288 hospital/institution Veltassa units were sold.

"Relypsa previously said that it anticipates a gradual launch ramp due to having to break new ground with physician practice as Veltassa is the first approved chronic hyperkalemia treatment and physicians are used to episodic treatment by discontinuing RAAS inhibitors and/or short-term treatment with sodium polystyrene sulfonate (SPS)," the analyst commented. "While we understand there are positive anecdotal comments from physicians testing Veltassa, we believe widespread use could take some time as we understand patients may visit their specialists every six months; however, our long-term view of Veltassa being a breakthrough and potential billion dollar treatment for hyperkalemia remains intact."

[H2R]

May 16 8-K: Scripts Report

http://investor.relypsa.com/secfiling.cfm?filingID=1193125-16-591863&CIK=1416792
(Reformatted for legibility)


In the outpatient setting:
• 1,216 new patients started taking Veltassa with a free starter supply.
• 928 outpatient prescriptions were covered by payers and dispensed (retail TRx).

In the hospital/institution setting:
• 288 units were sold to hospitals and other institutions (non-retail).

Comparison to Previous Month


New patients who started taking Veltassa with a free starter supply
March 1-31, 2016 1,277 (average 290 patients/week)
April 1-30, 2016 1,216 (average 290 patients/week)

Outpatient prescriptions covered and dispensed (retail TRx)
March 1-31, 2016 706 (average 160 prescriptions/week)
April 1-30, 2016 928 (average 221 prescriptions/week)


Hospital/institution units sold (non-retail)
March 1-31, 2016 201 (average 46 units/week)
April 1-30, 2016 288 (average 69 units/week)

[JoshuaHarris]

This must be old? Date?

[Mitshu35]

AstraZeneca rumored to be mulling Relypsa takeover, Daily Mail says AstraZeneca (AZN), which previously acquired ZS Pharma, is now rumored to be eyeing ZS's chief competitor, Relypsa (RLYP), according to the Daily Mail. Market talk was of a potential $46 per share offer for the developer of renal, cardiovascular and metabolic disease treatments, said the Daily Mail's "Market Report." Relypsa, which has been mentioned as a potential takeover target in several prior media reports, is up 2% in pre-market trading.

[JoshuaHarris]

FDA rejection of ZS-9 would be idea for Relypsa. IMO pps would soar. More likely is approval but hopefully with BB warning.

[warrentt]

Does the majority think if FDA approve ZS-9 on May 24 then Replypsa have greater chance of being bought out?

If the FDA reject ZS-9 then wouldn't Replypsa worth a lot more?

[thet0nzz]

H2R---
I'm sure Larry Smith will be issuing an update on RLYP in light of the 150M debt financing. Would you be kind enough to give a summation of his thoughts when he does so? Thank you in advance.

[ClearlyStocks]

Left for dead

[H2R]

European Submission for Veltassa (PR)

Vifor Fresenius Medical Care Renal Pharma and Relypsa Announce Submission of Marketing Authorization Application Requesting European Approval of Veltassa® for the Treatment of Hyperkalemia

ST. GALLEN, Switzerland and REDWOOD CITY, Calif., April 25, 2016 (GLOBE NEWSWIRE) -- Vifor Fresenius Medical Care Renal Pharma Ltd. (VFMCRP), a common company of Galenica and Fresenius Medical Care, and Relypsa, Inc. (NASDAQ:RLYP), a biopharmaceutical company, today announced that VFMCRP has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Veltassa® (patiromer) for oral suspension. VFMCRP is seeking approval of Veltassa for the treatment of hyperkalemia, or elevated blood potassium levels, in the European Union (EU) through the EU centralized procedure.

Veltassa was approved by the U.S. Food and Drug Administration (FDA) for the treatment of hyperkalemia in the United States on October 21, 2015, becoming the first new medicine in more than 50 years for people with elevated serum potassium.

"The MAA submission for Veltassa represents an important milestone in our efforts to bring hyperkalemia patients in Europe a new treatment option as soon as possible," said Stefan Schulze, chief executive officer of VFMCRP. "Relypsa has been an excellent partner supporting the preparation of this robust submission, which is based on positive efficacy and safety results from an extensive clinical development program that included many patients from Europe."

"As a recognized global leader in nephrology, VFMCRP shares our commitment to bringing Veltassa to hyperkalemia patients around the world," said John A. Orwin, president and chief executive officer of Relypsa. "This MAA submission brings us another step closer to achieving that goal for people with hyperkalemia in Europe."

The European submission for Veltassa is supported by data from a comprehensive clinical development program that included:

The pivotal Phase 3 OPAL-HK study, which was conducted under a FDA Special Protocol Assessment and evaluated Veltassa in hyperkalemic patients with chronic kidney disease (CKD) who were taking renin angiotensin aldosterone system (RAAS) inhibitors;
The Phase 2 AMETHYST-DN trial, which evaluated the use of Veltassa over 52 weeks in hyperkalemic patients with CKD and type 2 diabetes who were taking RAAS inhibitors;
An open-label, uncontrolled, Phase 1 study that evaluated the onset-of-action of Veltassa in hyperkalemic CKD patients.
The European submission will undergo a formal acceptance and validation phase by the EMA during May 2016. After this period, an official regulatory review will be undertaken.

[H2R]

Smith On Stocks: Buy recommendation

https://smithonstocks.com/relypsa-analyzing-march-results-of-the-veltassa-launch-rlyp-buy-17-60/

(Won't copy the subscription based article; SoS is one of my favorite sites)

Main ideas:
Strong momentum on small numbers for now, difficult to project for the next couple of years;

May 26th PDUFA for ZS-9 could turn into a catalyst depending on FDA's assessment.

Buy recommendation at current PPS

[H2R]

And a negative outlook from SA's George Rho (Whom I do like actually)

http://seekingalpha.com/article/3965876-avoid-relypsa

The main point is that in the next couple of years, the revenue will be low and that the projection past that is more of an art. I'm more optimistic, but I thought this would be worth sharing here too.

Furthermore, George Rho does not give credence to an upcoming BO.

The Company's One (and only) Product

Veltassa was approved by the FDA on October 21, 2015, making it the first new medicine approved for the treatment of hyperkalemia, or elevated blood potassium levels, in more than 50 years. Made in powder form consisting of smooth, spherical beads, the potassium binder is mixed with water and taken once-a-day with food. The new medicine is not absorbed and acts within the gastrointestinal tract, binding to potassium in exchange for calcium, primarily in the colon. The potassium is then excreted from the body through the normal excretion process.

Veltassa is not be used as an emergency treatment for life-threatening hyperkalemia, though, because of its delayed onset of action. Very important, too, the prescribing information for Veltassa includes a Boxed Warning that the drug binds to many other orally administered medications, which could decrease their absorption and reduce their effectiveness. As such, the instructions call for other oral medications to be administered at least 6 hours before or 6 hours after Veltassa. Doctors are to choose between Veltassa and the other oral medication if adequate dosing separation is not possible.

As noted above, Veltassa was launched late last December. In the out-patient setting, it's provided to patients as a 30-day supply, consisting of 30 single-use packets. The wholesale acquisition cost is $595 and this price is the same for each of the three dosage strengths. The wholesale acquisition cost for hospitals is $119 for a pack holding four single-use packets of the 8.4 g dose.

Wall Street's consensus mean revenue estimate for 2016 is $39.4 million, derived from 12 data points, which range from a low of $23.6 million and a high of $66.5 million. The consensus figure for 2017 is $86.1 million, with a low and high of $27.6 million and $127.6 million, respectively. Wall Street's bottom-line expectations also vary greatly for both years. Significantly, though, not a single analyst - out of 12 for 2016 and 14 for 2017 - expects Relypsa to be profitable in either year. The consensus is for losses of $5.23 a share this year and $3.82 next year.

[H2R]

8-K: Positive Outlook from Brean Capital Analyst Difei Yang

https://tipranks.whotrades.com/blog/43710745426?utm_source=maxsocial&frpp_id=zacksFbLnkdPost&utm_term=zacksFbLnkdPost&utm_content=post

Brean Capital analyst Difei Yang weighed in on biotech company Relypsa after the company updated its March and Q1 monthly prescription numbers through the 8-K. Relypsa’s lead drug is Veltassa, used to treat elevated potassium levels.

The analyst notes that, “while the [prescription] data did not blow investors away, it met our expectations; as such, we are keeping our Q1 and full-year estimates intact.” The data from the March and Q1 data revealed that the company reported 1,277 units of free starter-supply; a 75% increase from the month prior, and 706 retail units, marking a 102% increase from the month prior. Yang elaborates on these figures, explaining, “With the numbers meeting our expectations, we are keeping our full year sales estimates the same,” restating her 2016 sales estimate of $29.7 million, well below the consensus of $39.4 million. However her first quarter sales estimates of $7.3 million are in-line with consensus.

Yang explains, “Given significant unmet needs for hyperkalemia, we assume a conservative revenue forecast at a 7% discount rate. Our estimates assume a slow market acceptance of Veltassa and imminent approval of ZS-9.”

Further, Benzinga reported late last week that Relypsa has dropped Centerview as its M&A advisor, though Relypsa has declined to comment on this. In light of this, Yang comments, “Though Centerview is now out of the running as the M&A advisor, we still believe that a deal may materialize.” Further, the analyst assures, “We still view a take out as being probable due to strategic fit with a larger pharma company.”

Despite the analyst’s conservative outlook, Yang reiterates a Buy rating on the stock with a $26.00 price target.

[H2R]

Script Numbers 8-K, April 15:
http://investor.relypsa.com/sec.cfm

The 8-K goes over the end of month scripts. I had to reformat from the 8-K, hopefully that kept it clear.

March 1-31, 2016
In the outpatient setting:

• 1,277 new patients started taking Veltassa with a free-starter supply.
• 706 outpatient prescriptions were covered by payers and dispensed (retail TRx).

In the hospital/institution setting:
• 201 units were sold to hospitals and other institutions (non-retail).



Overall Quarterly Numbers

Outpatient setting

New patients who started taking Veltassa with a free starter-supply
Jan: 409 (average 102 patients/week)
Feb: 812 (average 203 patients/week)
Mar: 1,277 (average 290 patients/week)
Q1 : 2,498

Outpatient prescriptions covered and dispensed (retail TRx)
Jan: 99 (average 25 prescriptions/week)
Feb: 350 (average 87 prescriptions/week)
Mar: 706 (average 160 prescriptions/week)
Q1 : 1,155

Hospital/institution setting
Hospital/institution units sold (non-retail)
Jan: 56 (average 14 units/week)
Feb: 117 (average 29 units/week)
Mar: 201 (average 46 units/week)
Q1 : 374

[Vector93]

Benzinga?! Are you serious?

People actually fell for this?!

"The source added that due to the expense of such expertise, Centerview's presence in ongoing M&A evaluation at Relypsa can only occur over a limited period."

That's not how this works. That's not how any of this works!

This actually makes me think the deal is done and someone is desperate to GTFO before they find themselves short at +$60.

[go2sleepjj]

Big short tomorrow

[ADVFN_beastmode]

Trash!!!!

[faxedreceipts]

I'm guessing this goes back to the pre BO rumor PR from the other day. The company needs to sell the product and stop the rumors.

[H2R]

Consensus $42: SA O'Neil Summary of BO Potential PPS

IF (big IF) the BO is going through,
http://seekingalpha.com/article/3964623-relypsa-rely-rumors

What are analysts saying about the deal and the upside potential?

Wedbush - outperform and $52 PT: most logical acquirer is Sanofi, which "has been clearly successful at counter detailing metal-based phosphate binders." Sanofi is already involved with Veltassa and is likely to accelerate Veltassa uptake considering its long-term relationship with nephrologists who prescribe phosphate binders. ZS Pharma equivalent price is $62 per share based on 43.3 million shares outstanding.

Citi -$30 PT: low end of the range is the 42% premium for ZS Pharma last year, which translates to a $1.4 billion price or $33 per share. High end of the range - Veltassa peak sales of $770 million versus ZS-9 estimate of $930 million and a deal based on ZS Pharma peak sales multiple, which translates into $51 per share. The firm also noted that there were four additional bidders for ZS Pharma in addition to AstraZeneca and Actelion.

Stifel - $36 PT: DCF using a big pharma cost of capital (8%) and a 25% tax rate yields $55 per share. The firm was speculating a $75 takeover price in December 2015, but has lowered it due to Veltassa's lower than expected uptake. Stifel also thinks that Relypsa's negotiating position is somewhat constrained due to financing needs and that the company would need $500 million to bridge it to cash flow break-even. In a note from December 2015, Stifel noted that "any of the Veltassa-mediated anti-hypersensitive benefit speculation was to be validated in a large/prospective randomized trial - which the company has hinted on initiating in FY16 - then it might be equally appropriate to argue a ZSPH-like bid may not come close to appropriately reflecting longer-term valuation."

BTIG thinks Relypsa could fetch $45 to $50 per share.
Raymond James (market perform) is questioning the timing of these rumors and thinks that fair value is around $16 based on Veltassa peak sales of $920 million by 2027. The firm's bull case scenario assumes a Veltassa peak within 6 years, which could drive the stock to the mid-$50s while they think the acquisition price should be around $35.
Cantor Fitzgerald - $42 PT: Relypsa takeover makes sense for the firm. Based on ZS Pharma takeout, Relypsa could fetch $75 per share.

The consensus price target is $42 and most of the analysts speculate that the takeover price should be above that level - the average takeover price estimate is around $53. Citi has the lowest price at the bottom of the range ($33 per share), but I think that the rationale for the low end of the range does not make sense since ZS Pharma's share price was near all-time highs when the takeover was announced. The estimate also completely disregards the value of the company as it just slaps a premium on the current price based on the ZS Pharma deal.

Note: SmithOnStocks says between 35 and 90, depending on a number of scenarios.

[BigGreen101]

Nice link.

As for the label, RLYP did in vitro drug-drug interaction (DDI) and found Veltassa interacted. The FDA then issued guidance for other compounds to test this effect, which includes ZS-9.

Unless ZS-9 has been tested in vitro and potentially in vivo, this compound will also get the same label as Veltassa. A second factor for ZS-9 is the salt content, which will restrict use in some patients. JMO