golong? The FDA did not ask for additional clinical data because they never even looked at what they got (last minute). Iit wasn't from ZS005 (most likely) which is the LT trial to see if ZS-9 is safe to use beyond a few weeks. I do agree with your financing/cost issues as we get through the next 2-3 months it will be a bigger issue.
Pharma - get you facts straight please. The $40M was just the initial contract payment. There are other "payments" with milestones coming THEN the 22% royalty kicks in once Veltassa gets EU approval. Relypsa also avoided the expense of launching V in all other countries EXCEPT Japan (Asia right?).
Glenn - did you find anything on Wainwright (Arce)? Cowen chimed in as a buy on 5/27 but still no PT
anton - she did great research for Cantor on relypsa (had a $42 PT too) last July then moved on to Mizuho in September. She also set a $42 PT in November after approval. Not sure WHY she did a 180 of late - makes no sense based on all we now know. Her ranking have soured (with the 2016 BIO smash down) so maybe she thought she would play the sell side? Her Credibility has taken a major hit IMO.
Lurker - I may be taking a BIG LEAP here but I have the gnawing feeling that the problems with ZS-9 are bigger than what we now have heard (manufacturing). They changed their ZS005 trial significantly (IMO) and won't have data available probably until next Feb-Mar - IF they get all their patients to 12 months. Then the SAE's - are they worse or better or same as November's %'s? Besides financing here, everybody is pounding on the 4 month script numbers in a NEW market!!! I agree with cancelling the SNY contract because they should be adding 2K scripts/month by May or at least June to the tally. IF this CKD.HK, PAH and other indications for Veltassa markets are too small (over estimated) than we were all spoofed by EVERYONE involved (key Docs, NKF (kidney foundation) and the lot. This market is just ridiculously chopping down almost any BIO that is not a BP for reasons unknown to me. We took our hits starting last August and one would have to believe they (mm's, algorithms, banks etc.) should be easing up on BIOs a little. Overpriced drugs and outrageous hospital costs are not every BIOs issue or problem. Anyway - GL2U
Thx Anton (not sure why the site I use is wrong) Net ADD was 2.3M+ shrs
from the 13F/13G website but I see it is inaccurate (agree) so March 31st from NASDAQ:
ORBIMED ADVISORS LLC 03/31/2016 7,400,000 (held)
JANUS CAPITAL MANAGEMENT LLC 03/31/2016 4,383,213 612,218 (added)
JHL CAPITAL GROUP LLC 03/31/2016 3,000,000 750,000 (added)
STATE STREET CORP 03/31/2016 2,216,498 1,141,229 (added)
VANGUARD GROUP INC 03/31/2016 2,083,434 123,471 (added)
DEERFIELD MANAGEMENT CO 03/31/2016 1,873,471 973,190 (added and added more 2nd Qtr)
BLACKROCK FUND ADVISORS 03/31/2016 1,773,301 182,193 (added)
FMR LLC 03/31/2016 1,753,800 293,600 (added)
WELLINGTON MANAGEMENT GROUP LLP 03/31/2016 1,105,296 (897,185) (reduced)
FRANKLIN RESOURCES INC 03/31/2016 801,100 (held)
BLACKROCK INSTITUTIONAL TRUST COMPANY, N.A. 03/31/2016 729,438 9,019 (added)
SUSQUEHANNA INTERNATIONAL GROUP, LLP 03/31/2016 541,088 (266,577) (reduced)
EMERALD MUTUAL FUND ADVISERS TRUST 03/31/2016 518,859 32,500 (added)
UBS ASSET MANAGEMENT AMERICAS INC 03/31/2016 515,790 86,890 (added)
EMERALD ADVISERS INC/PA 03/31/2016 507,359 15,770 (added)
ROYCE & ASSOCIATES LP 03/31/2016 467,700 60,000 (added)
VOYA INVESTMENT MANAGEMENT LLC 03/31/2016 453,720 6,000 (added)
MARSHALL WACE LLP 03/31/2016 448,773 448,773 New
JPMORGAN CHASE & CO 03/31/2016 378,047 4,419 (added)
SCOPIA CAPITAL MANAGEMENT LP 03/31/2016 363,810 363,810 New
annie - how do you know this? Logically, all the points needing clarification have been done/accomplished. YES, we have financing issues in 2017 and the launch/sales has not knocked our socks off but it is a new drug in an untapped market. So, now is the time IF there is to be a BO because there is nothing left to hurdle. Even the BB will be removed of diminished. We have patents until 2029/2030. MAA has been submitted (should hear of acceptance soon). 15M shares traded on Friday, who were the sellers and buyers or were shorts leaving their position(s)?
Here is the top list of Tutes on March 31st:
Orbimed Advisors LLC 7,400,000
Janus Capital Management LLC 4,383,213
State Street 2,216,498
Vanguard Group 2,083,434
Deerfield Management Co NY 1,873,471 (added lately)
Blackrock Fund Advisors 1,773,301
Fmr LLC 1,753,800
Wellington Management Co LLP 1,105,296
Franklin Resources 801,100
Blackrock Institutional Trust Company, NA 729,438
Emerald Mutual Fund Advisers Trust 518,859
Ubs Global Asset Management Americas 515,790
Emerald Advisers Incpa 507,359
Largest 100K+ shares added to their positions (or new) in 1st Qtr:
VISIUM ASSET MANAGEMENT, LP 03/31/2016 1,583,300 1,338,986 (added)
INVESCO LTD. 03/31/2016 566,028 566,028 New
BAKER BROS. ADVISORS LP 03/31/2016 1,500,000 500,000 (added)
SENZAR ASSET MANAGEMENT, LLC 03/31/2016 1,104,998 415,891 (added)
NORGES BANK 12/31/2015 443,525 403,525 (added)
PRICE T ROWE ASSOCIATES INC /MD/ 03/31/2016 9,645,081 368,935 (added MORE!! why?)
RENAISSANCE TECHNOLOGIES LLC 03/31/2016 183,787 183,787 New
MILLENNIUM MANAGEMENT LLC 03/31/2016 213,238 168,472 (added)
Your choice - respectfully. Did you buy some shares on Friday? I would think 95% of those who read this MB are disgusted with "wall street" and the market's manipulation of RLYP. If the "tutes" were selling this past qtr or even the last 7 weeks, I would be out (too). But for now, THEY must see some upward movement soon jst not sure what will drive that. GL
One would think that Relypsa is in a perfect situation with all that has been accomplished in the last 6+ months. So, unless the CKD/HK (tell that to the National Kidney Foundation) is a rare disease that does not require medication (most everybody and AZN would be wrong then), RLYP is a great buy. Remember we carry forward about $300M in debt (is that correct?) which would offset taxes on revenue for the purchaser. So, maybe the forward looking revenue is $500M/yr. Still make RLYP worth at least $1.8B - $2.3B. Add the $200M+ in cash (not including the $150M loan). Add to that no competition for probably 12 months! To me, this now seems like a NO BRAINER. GLTA
topgun - more players are in this over $30/shr (tutes) and they will have a say but I would agree with a $2B BO which will pretty much cover ALL bigger owners cost + some gains. $46-$50 will avoid lawsuits etc. Selling for $28/shr is $1.25B or so and that would be a scam!
gamebirdy - For me, your post sums it up. this kind of comment should be posted by some of our loyal Analysts that have a clue. The hill that was once there for ZS-9 has now become a mountain for a variety of reasons. This drug would have to be equal, if not greater, than Veltassa but it is actually inferior. So, why should it be approved with possible negative patient impact? Also, maybe the data was ZS004E's but why would they (AZN) have waited so long to send to the FDA? As for Veltassa, the positives keep coming with the additional studies/trials. BP should be seeing ALL that has occurred. The only real issue that remains (besides RLYP's financing) is assessing the CKD/HK market's size (which goes beyond that market per PAH and other results) for Veltassa AND SALES reach. Get rid of Sanofi now and pay off VIFOR (Galenica) and you (BP) own the whole USA/ROW market. Huge opportunity!!! thx
New data was from/for the manufacturing issue/correction (per FierceBIO/AZN). So, the extension of ZS005 was not even discussed/mentioned. Those 2 new trials in November could have been for this issue?? Not sure but either way - CRL. They sure as heck did not just find out about this in the last few weeks.
Agree - now is the time with the separation between any competition and all the other DUCKS (see checklist 2016) are in a row. Next week should produce some REAL noise
Launch Veltassa (check)
Secure $45M at the ATM (check) YUCK1
Complete Phase I DDI trial and report (check)
Veltassa gets covered by most insurance plans (check)
Have Veltassa added to Medicare Formulary (CHECK)
Report monthly on Scripts (check)
Insiders purchase shares (check)
Tutes add in 1st Quarter (over 2M shares) (check)
File MAA in the EU for Veltassa approval (VF) (check)
Secure more financing of $150M to get into 2017 (check) - YUCK2
File sNDA with FDA to change label BB from 6 hrs (check)
Report on other trial's progress/successes (check)
ZS-9 does NOT get approved May 26th - delayed 9-16 months) CHECK!!!
And the PPS is barely $18? YUCK3
Have a good weekend/holiday everyone and feel free to add to the checklist!!!
And these indexes still loom heavy over BIOs. Nasdaq is looking better but that did little for us today!
anton - almost 15M shares traded and EVERYONE but a few lately lost today. Cracker Box Palace - we were expecting this - the CLOWN show continues