LOL, Yes counting chickens before they hatch is fun, unless U R Bryan, he counts broken eggs that are safely in the nest. Not nearly as many eggs will break as he hopes, but maybe more will hatch than I hope. This could get Bryan to puke again, lol, let's see. Blaah, all over his libraries computer.
Another well thought out response. U need ask your boss for a raise, let him know you intend to do some real research, and give more than glib responses. Projected revenue from a pipeline falls in that category. Stay out of the dumpster, take some Pepto, hope you feel better.
Question? is that 3.5 billion the total market? OR opko's share? GM only sells so many cars, the competition sells the rest. The big pharmas competing against OPKO are not going to say, here take the HGH market or CKD market we give up. 10% penetration is big though I do expect Opko to take the bulk of CKD, and HGH markets, until it happens, it is spec. Chuck, do not spend your profits just yet, lol., wait and see, might even be bigger than 3.5 NO ONE knows yet.
An interim analysis of 6 months data demonstrated that all doses of Lagova used in the study provided strong catch-up growth response better than historical controls of daily growth hormone therapy.
The baseline characteristics of all patients were comparable among all groups. Interim analysis of the PK profile following administration of Lagova demonstrates a significantly extended half-life as reflected by the T1/2 and AUC respectively. A dose dependent PD (IGF-1) response was observed between Lagova cohorts, reaching steady state with no accumulation or excessive levels. All cohorts demonstrated promising “catch-up” growth, in line with reported age and GHD severity-matched data. The annualized height velocities are more than 12 cm, which correlates with the PK/PD profile in those patients.
First to cover wins.
Based on ? You R throwing out a number 16-21 based on what revenue projection? If you take 4k, psa test, testosterone test, vit D tests, Rayaldy, Rolapitant, HGH, and the current but growing 100M pharma revenue, what type of revenue are you looking at? Combined these are no less than 25Billion total markets, if opko gets 5% penetration, that puts revenue in the 1.2-1.5B range? So curious where you get your PT from, and what revenue numbers you think are attainable? I think revenue rayaldy is no less than 400M, but likely over 1B, or 2B alone. But even at 400M, Rayaldy, 100M HGH, 25M rolapitant, 50M for all diagnostics, and 200m all pharma division non-biotec, ie, vitamins, veternary etc., that is still roughly 800m, but it will be more. Opko will do more than 2-3% penetration, at .5-1% penetration opko is in your 16 range.
Everyone has an opinion. The reality is at this point all we can do is buy and wait. So many look at the addressable market and get all excited. The addressable Rayaldy market is 12 Billion, reality is only about 1/3 take a script, 4b, so that is the real market until the sales prove otherwise. It is possible that the drs. treating the other 2/3 of the patients with NOTHING or OTC vitamin D are doing so waiting around for Rayaldy, or they do not SEE a NEED for a SCRIPT. It is also possible they think the current available drugs do more harm than good which is not off the table either. Truth is everyone is giving their best guess, but we JUST DO NOT KNOW anything yet. Taking as little as 10-20% market share is BIG PENETRATION. So of the 4 billion currently on a script Rayaldy and OPKO will do well to get 10%-20% year 1, 400K-800K, but like everyone here, that is my guess. If they could pull that off total revenue will be over 1b, pt 28-32.
From the 4th Q earnings report: Net loss for the full 2013 year was $114.8 million compared to $31.3 million for the 2012 period. The increase in net loss for the 2013 full year was primarily related to the previously mentioned research and development expenses related to our Rayaldy™ and hGH-CTP clinical trials, interest expense on the 2033 Senior Notes, and non-recurring costs related to strategic and business development activities, as well as the following non-cash charges:
$36.5 million related to the change in fair value of derivative instruments, principally related to embedded derivatives that are part of the 2033 Senior Notes;
This 36.5 loss ie., senior notes are the bonds.
$11.5 million on losses from investments in equity method investees;
$8.7 million loss from early conversion of some of the 2033 Senior Notes and
$6.9 million related to the change in fair value of contingent consideration payable in connection with prior acquisitions.
So of this 114.8 loss, 36.5 + 8.7 = 45.2 million was from the bonds, but not the interest on the bonds, just conversion, and I believe PPS at year end minus conversion price. Total paper loss last year was
63.6 million or 55.4%.
My point is this big paper loss, 36.5M gets reduced by whatever percent of total bonds that were just converted, but I believe the actual paper loss is free to vary based on current share price, and original conversion price or maybe a function of bond prices moving around.
Last paragraph of Article above says 1 year trial, this is mid point, 6 month data, so by EOY. It is only phase 2, so NDA as it stands maybe late 2016, approval 2017.
I see no reason the fda does not fast track this treatment if phase 2 is as expected.
The last 2 sentences says it all, the drug is equal to standard of care because it is only a long acting version, weekly not daily injections, fda will be a slam dunk once phase 3 is finished. Not only one instead of 7 injections, think of the COST savings for the individuals or the insurance companies. YES we will only pay for this once weekly injection, we no longer cover daily injections for the same drug.
MIAMI--(BUSINESS WIRE)-- OPKO Health, Inc. (NYSE: OPK), a multinational biopharmaceutical and diagnostics company that is developing a novel long-acting human growth hormone product (hGH-CTP) for the treatment of growth hormone deficiency (GHD), today announced it will hold a conference call and webcast on Tuesday, June 24, 2014 at 8:30 a.m. EDT (7:30 a.m. CDT).
During the call, OPKO Biologics management will discuss data from the company's advanced phase 2 trial of hGH-CTP in growth hormone deficient pediatric subjects. The pharmacokinetic and pharmacodynamics portion of the results will also be presented at a poster presentation on the prior Monday afternoon from 2:00 p.m. to 4:00 p.m. EDT (1:00 p.m. to 3:00 p.m. CDT) during the International Congress of Endocrinology and Endocrine Society's Annual Meeting and Expo at the McCormick Place West in Chicago, IL. The poster is titled "Pharmacokinetics and Pharmacodynamics Profile of Once-Weekly, CTP-Modified Human Growth Hormone (MOD-4023): Phase 2 Dose Finding Study in Children with GH Deficiency". An additional poster titled "Production and Characterization of MOD-4023, a LONG Acting Growth Hormone and Supporting Clinical and Commercial Drug Product Supply" will be presented in parallel.
The data to be discussed during the call will include six month height velocity and safety data from the company's phase 2 trial, which is a one year dose finding study administering hGH-CTP to growth hormone deficient children once a week using daily hGH as a comparator arm. These data affirmed that a single weekly injection of hGH-CTP has the potential to replace seven consecutive daily injections of currently marketed hGH, further validating the optimal dose and dosing regimen for the upcoming phase 3 trial in pediatric patients. In addition, hGH-CTP demonstrated a very good safety and tolerability profile in this ongoing study, with no unexpected adverse events.
I think it is all spelled out in the deal, I forget what the first amount to be paid is, but maybe only 10M or so. The payments are staggered, based on events, total 110M I think. That is all before royalties.
MET ALL primary and secondary end points announced May 12TH, SO it is a go, FDA announcement any day now. Notice how another Lakeweed prediction falls into the trash. His LOGIC OPKO did not pay anything for the drug so it will fail. AMAZING, and people bought into THAT!!!! Best 5 million investment of decade, well time will tell.
As of now, no shares available to short at IAB. See if today's 6.68 holds, that is the new line in the sand, but nwbo did bounce up .50 off that line. Chance it is retested 50/50. If Nwbo does damage control, the chances go way down. As of the close no shares to short is a positive. If somehow 6.68 gets breached, we have a small gap around 6.00, max pain 5.80, small shot at getting there.
" First read with an open mind " Opening sentence of dribble, " I do not believe direct has any chance " talk about close minded, no reason to read beyond the first sentence. Obviously written by someone with blinders who already knows all, has solid conclusions, is inflexible, without the ability to be objective. The mechanism of action intuitively is too overly simplistic for the likes of gravity to work. An invisible force pulling on things, get real. There is always a dearth of evidence until there isn't, then it becomes so obvious every kid knows it is true without evidence. Well, let us say they do not need a peer revue to confirm gravity, it becomes a given in time.
yah, done deal. It might be only 50% fund ownership etc., I cannot be bothered figuring it out, I leave math to bryan.
We all know opko IS A private company under Frosts control 100% under his control. WE ARE along for the ride. Insiders own OVER 50%, closer to 55% of all shares. That leaves 45% for FUNDS, SHORTS, and us, retailers. So when fund ownership looks small it is not 18% of 100% as it appears. Fund ownership is nearer 70% of float, BUY A clue, silver knows this, he might be a dope, but he knows, and distorts. No opko LONG gets fooled by the MF,
LONG, lol, hi Miami.