golong ($6.6M every quarter not month) - None of the stock owners (Institutions/HFs) would accept any BO below $2.5B. First of all ZS Pharma was bought w/o any approval and look at where their drug might be headed. Secondly, did we not do a secondary in March for $38/shr? If so, then the expectation would be 3X of where we are now which would be about $67/shr and almost $2.8B today. I believe an approval is worth a lot more than an NDA with the FDA with a trial still only 10% completed.
Is a secondary possible? If the revenue (sales) is not as robust initially AND the $6.6M each qtr from VF is not enough, they may need to raise another $100M+ with 3M shares at $35 or so to cover any additional trials (PAH/BP reduction). This could be a boon to the stock's PPS also. They need to get an MAA in the EU early next year (with VF running lead) and get approved in Japan in 2016. That will bring in the needed revenue and potentially remove any more need to dilute. Sorry I misunderstood the initial ???? Have a good thanksgiving!
As for a Buyout? I think all parties will want to see what occurs in the 1st Qtr of 2016. AZ projects that ZS-9 will have over $1B in sales (I think by 2018) but how they came to that w/o pricing is a bit confusing. IF we say that Veltassa also achieves $1B in sales by 2018, and all goes well in the 1st Qtr, we may exceed the $2.7B offer and maybe go for $3B (about $75/shr).
The $40M upfront payment from VF? They are getting that in $6.6M increments over 6 quarters (starting 3rd Qtr 2015).
"Relypsa Inc (NASDAQ:RLYP) closed at $21.52 with an increase of 0.14%. The $895.95M company on November 6, 2015 announced results of a pre-specified sub-group analysis from the Phase 3 OPAL-HK trial of Veltassa™ (patiromer) for oral suspension. Data showed Veltassa significantly reduced and maintained control of blood potassium levels in hyperkalemic CKD patients age 65 and older who were also receiving renin angiotensin aldosterone system (RAAS) inhibitor therapy. Veltassa was recently approved by the U.S. Food and Drug Administration as the first new medicine for the treatment of hyperkalemia in more than 50 years.
A separate post-hoc analysis also from the OPAL-HK trial showed Veltassa’s efficacy in treating hyperkalemia was not diminished by concomitant use of diuretics. Veltassa was well tolerated in both sub-groups, with mild-to-moderate constipation as the most common adverse event.
“These data suggest Veltassa’s efficacy is similar for patients older than 65 years and for younger patients. This is important because older patients have a greater chance of developing elevated blood potassium levels due to common co-morbid conditions,” said presenter Matthew R. Weir, M.D., lead investigator of the OPAL-HK trial and professor and director, Division of Nephrology, University of Maryland School of Medicine. “We have also shown in a retrospective analysis that Veltassa’s efficacy remained consistent with concomitant diuretic use. Diuretics are frequently prescribed to people with CKD and heart failure to reduce fluid volume and blood pressure, or to control symptoms.”
Lurker, that is a tough one. But IF they get 5K patients the first month and grow by 5K each month, that gets them about 60K patients. Remember each physician has other physicians they are associated with and each have many patients. They have had 10 weeks working on this launch. So, to ONLY get 5K patients would be a bit disappointing. Sanofi has lots of "connections" and an existing network AND has "skin in the game" too. This is why the PPS is not as advanced as it should be. Nobody really has a good feel for the possibility/scripts, so most are estimating conservatively.
That would 96K (at $500 per) monthly prescriptions or maybe 40K-50K patients in 2016. Unless that is after costs (labor, R&D)? Seems WAY too low to me. I have (WAG) 35K patients at $3000 (6 months) which is my low end and is over $100M for 2016.
Since Veltassa is already approved, does anything preclude Relypsa from providing, and doctors from prescribing, before January. Not implying sales, but "free" use for any doctor requesting some "samples"? Unless the drug is not available until January. One would think that might be a prudent move. This way some doctors would feel assured before actual sales/costs?
Location Bridgewater, NJ
Date Posted: November 24, 2015
Manager, Project Engineering will have responsibility for implementation and maintenance of utilities and operations for internal and external manufacturing and development of pharmaceutical drug products as well as a supporting role for process development experimentation.
* Key member of a dynamic scientifically driven team, dedicated to the development and optimization of robust manufacturing processes for drug products.
* Owner and/or the Execution Lead, for one or more processes in their respective area of specialization, including but not limited to: Implementation and maintenance of internal manufacturing/process development utilities (HVAC, CCA, N2, TCUs, Fume hoods, etc.) and facility (clean rooms), technical transfer of existing technology to contract organizations.
* Work with external contractor network to support manufacturing and process development capabilities.
* Key contributor to process development strategies to define manufacturing processes for clinical and commercial products.
* Design and execute complex experiments to characterize drug product manufacturing processes utilizing various technologies.
* Apply fundamental engineering principles to characterize and solve process challenges across multiple unit operations, utilizing both experimental and process simulation/modeling approaches.
* Utilize appropriate research tools, instrumentation, technologies, and methodologies to support efficient and effective drug product process development.
* Assume departmental responsibilities for assigned projects and equipment.
* Maintain safety, regulatory, and compliance standards as they relate to the manufacturing and development of pharmaceuticals.
* Prepare technical reports, publications and oral presentations
Anybody ever see this reiterated, changed or in the news??
"BofA/Merrill Lynch reinstates coverage on Relypsa, Inc. (NASDAQ: RLYP) with a Buy rating and a price target of $55.00.
Analyst Catherine Hu expect Relypsa approval sometime in 4Q15. She sees limited risks to approval as the phase 3 trial was conducted under a Special Protocol Assessment with the FDA.
Hu said shares are attractively priced given the limited risks to approval and our expectation for a steady global sales ramp up over ~$1 billion."
This means BOFA agrees with Oppenheimer ($55), Nomura agrees with Wedbush ($75) and Cantor agrees with Mizuho ($42). Guggenheim is at $46 and Stifel is at $48 and Citi I think is at $45. Am I missing any?
JJPP (Biologix SA article) posted that the valuation for Relypsa is minimized by their deal with VF for rights outside of US and Japan (still unknown value). Not sure that is true as a BIG Pharma could work its way through to own it all. But if the US is assess at minimally $1B/year (I expect more) and Japan is another $1B (not sure of this) what really is the value? Any other thoughts/opinions? Given the ZS005 data from ZS Pharma
Smile (don't kill me for posting this), if Merck wanted this company for $800m-$1B, I believe it would be sold. They get everything they "had" but now has been upgraded and the patented process. If the Cohorts are reaching (was it 8?) w/o SAEs and if tumor remission/reduction.......just not sure there are any offers in the making.
Let's see 10 days ago Paris attacks kill over 100 (130 last count) and the market actually moves up reasonably the next week.
Today, a Russian jet is shot down by TURKEY for a invading air space - and the market TANKS!!!
This is more #$%$ reason for the market to go down whenever it wants to. Push button ETFs etc. Garbage!
"BioMarin drisapersen approval probability near zero, says Baird
Baird believes BioMarin's chance of receiving FDA approval for drisapersen is near zero after further review of the FDA's briefing documents. The firm believes long-term exposure to drisapersen could lead to death with the chance of thrombocytopenia worse than they thought. Baird maintains its Neutral rating and lowered its price target to $100 from $147 on BioMarin shares, which are halted today as the FDA's advisory committee meets to discuss the New Drug Application for the drug."
as dysfunctional as the garbage poster(s) who is incessantly post drivel. Nobody who knows anything posts for obvious reasons and THAT will change soon enough. In the meantime, IGNORE works wonders!
Probably should have said slower enrollments versus dropouts. This trial will not get completed next summer but maybe the FDA still approves with "exceptions"? This is different than Veltassa since it is now approved and will be in the medical community (and not 50 years old). No necessity to cut corners for ZS-9 approval. Trading today is quite volatile, we hit $21.73 and dropped almost 50 cents in a minute - climbing back - market is taking notice?
Let's say you are almost correct? Then how can this trial replicate any real life situations as they keep adding to the exceptions versus the inclusions? Who is going to monitor these patients for ALL the possibilities when a decision (after initial treatment) has to be made going forward?
Lurker - probably trying to prove that ZS-9 actually "lowered" the BP when it was ridiculously high? FYI I posted earlier a change to the exceptions list of their trial that might explain there dropouts????
Also changed the following wording (I think these are included at the bottom of exceptions):
- Subjects on dialysis.
- Subjects randomized into the previous ZS-002, ZS-003, ZS-004, or ZS- 004E studies.
- Subjects on dialysis.
- Subjects randomized into the previous ZS-002, ZS-003, ZS-004, or ZS-004E studies.
- Documented GFR <15 mL/min within 90 days prior to study entry. (not sure what this is???)