roll outs scheduled through out South America, Russia and the Cis countries, and Europe. Currently 4k is available in England, Scotland and Wales, with other countries set to launch over the next 12-18 months. Israel is a given have not seen mention of Canada, but we do own one company up North so I am sure it is in the cards. Roll out might seem slow at first but a global launch takes time. Opko has interests in about a dozen countries and these inroads will be maximized.
Rolapitant final data and NDA in June-July, Rayaldy finishes phase 3 August, Outside chance England Nat Insurance kicks in, which has been an issue, and News on US insurance coverage on 4k. Outside chance on Hep B drug going to FDA, 4k launch in two three countries. Opko does not have a big home run cancer type drug, but it will hit a ton of singles. Opko has a stable of drugs that just work better than the current market leaders. Once a week injection, VS daily, = market leader in time. So nothing earth shattering but each event is one more step to profitability and eventual, eoy 2016 billion in revenue, pt 28-32.
He does erectile dysfunction and implants, so he could help them I guess, lol.
It is true, if a recommend is for stop for futility it can be ignored, but not for safety issues. My GUESS is that most/none continue if a stop for futility happens, and think the company would HAVE TO make this info public, but it is in fact an option the company can exercise. The DMC makes recommendations it is then up to the company to act. Safety concerns are a different issue with a different set of rules where the FDA gets notified, a stop for safety is immediate. A stop for efficacy can also be ignored, he does not mention that. If you stop for efficacy and the FDA deems the study under powered you have to start over and lose all data.
Yes I am aware of that, that said, this analyst has a reputation and a career. If he ever leaves LTS for another firm could outlandish upgrades and price targets for OPKO bring up ethics questions, morality questions ??? I doubt Frost has told him what to say, or price targets, it would jeopardize Frost's and DeGeeter's credibility. LTS is one of 4 firms with a buy rating, of those Oppenheimer and Jefferies carry more weight, everyone ignores the LTS upgrade because of the Frost connection. So we can through it out too, that lowers the pt from 12.83 to 11.83, lts has the highest by 1.00, he has always been higher by 1.00.
Opko is not close to profitable yet, R&D expense has gone way up year over year. We now have all the Prolar R&D expense, and just completed the 4k phase 3 study, plus multiple Rayaldee studies. In 2012 R&D expense was about 19 million, 2013 53 million excluding 4k phase 3. Revenue during that time went from 47 million to 96 Million. Loss per share went from .11 to .32. Though revenue doubled, R&D went up 2.5 times and the loss grew 3X along with R&D expense 2.5x.
Revenue last q was about 20 million, I expect near 23 million this Q, 15% Q/Q growth, the unknown is citicoline sales which could add 5-6 million bringing revenue to 25-26 million. Another unknown is Peru, and if that purchase generated any revenue, if so it will be small, maybe 500k-1 million.
Last year half the losses were paper losses on derivatives but the market ignores that, however Opko exited the year with more cash on hand. Expect loss in the .15 range, estimate is a loss of .10, so maybe a .05 miss but a shot at beating the 23M revenue by 2-3 million.
There is no hidden revenue or magic here, Opko needs revenue to double one more time to go eps. positive, it is going to happen but not for a few more quarters.
In the past 8 quarters, the day of earnings, the stock has moved as little as .01 to as much as a .25. I have a hunch the phase 3 studies might have cost a little more than was projected by the analysts, but then it is only a hunch. It would take a big revenue beat in the 8-10m range to move the stock, IMHO. Opko is just getting going, 4k will roll out slow, and do a gradual build of revenue as Opko launches it globally. That is the key, that and getting insurance carries on board. Waiting on England and think it happens this year. US will happen late this year early next.
For the past three years it was the 10th which is a SAT., so likely 9th or 12th I am figuring 12TH but only Dr. frost really knows.
Last year Opko had two beats and two misses, the beats, .02, and .05, the misses, -.07, -.11, with the biggest
loss in any Q being -.17 on an -.06 estimate. The miss was caused by derivatives not operating expense, the stock weakened by .25 for the week. Current estimates are 23M revenue, -.10 loss. The loss could be bigger if phase 3 was more expensive than anticipated, roll out preparation for 4k, money well spent, or if derivatives on the books swing negative. The loss is likely in the -.10 to -.15 range, but not more. That -.17 showed a LARGE derivative loss that will not be duplicated this period. Hoping for more than 23M in revenue, which is only 15% Q/Q growth, 25M would be nice at 25% q/q. The Y/Y comparison will be LOWER due to RXII purchase of 12 million of assets. Opko will not have " dismal earnings " but in line, with a few items that could cause a -.01to -.05 miss. Outside shot at beat if citicoline sales are in the 4-5 million range, and if Uruguay revenue is in the 500K range and derivatives swing positive. So obviously it is every ones best guess but these items will be in the equation whether a beat or miss.
Thanks, but most things are just my opinions based on looking at filings for background. All this the earnings will be terrible talk made me think why? Why would they be terrible? I see no single thing since expenses should have stayed steady more or less Q/Q. I mention why they could miss cause they have before, and also why they could beat, less likely, but they have beat before too. I expect hohum earnings near what is expected, max of .05 beat or miss. THE -.10 IS AN ESTIMATE only, the market treats them as if they are the holy grail from mount high, they are not. They are a couple of guys BEST GUESS, just like my estimate is my best GUESS.
Negotiating the price takes many many months in most cases, can be a year or more. Then there is the mater of uptake, how many Drs. will offer the treatment prior to approval. So there are two big unknowns and mystery revenue that will not likely materialize until 2015. Prior to finalizing the negotiations the phase 3 data will likely be out, the direct data a given. Funds have taken tiny positions, many because their charters require holding all stocks, or all in a sector. These funds have the best research but can still miss great buys, that said, of the 48 funds taking positions only one owns more than 1m shares, and combined all funds only own 6m/48 an average of 125k shares. Take out the one 2m holder the average drops to 85k shares per fund.
.0001% of assets for many.
The short interest is almost = fund ownership and with the small float shorting against the box is commonly practiced. This stock is fairly priced in this 5.00 range given the potential and risk. My take is the funds who really control the movement have no faith in the phase 2 data especially in light of imuc's stellar phase 2 data.
Nwbo will either go to a buck or to 1000, the market is waiting on phase 3 data, Germany could easily pull their deal if phase three fails, these are the reasons I think the market by and large has ignored Germany, the market does not believe.
I am long, but with a small position, gamble money.
There have been private placements that do not show up, regardless and including those, institutional ownership is small. If the market believed in the technology, and the importance of Germany nwbo would be nearer 50.00, than 5.00, this is an objective view. Noway this would be a 5.00 stock if the market thought phase 3 is to succeed and a potential cure for gbm was discovered by nwbo.
I am long because I think it works, and all longs are betting against the PRO funds who have ignored NWBO. By ignore I am saying 6 million mutual fund ownership is being ignored. We longs are all gambling on this one.
Press releases issued at or after ASCO’s public release do not violate ASCO policies. So my take is NWBO can give info on or after the 14th. If the data is exceptional I expect NWBO to announce a phase 3 for direct, or that they are looking to partner a phase 3 for direct. That is the optimistic outcome.
Go to asco and then exhibitors, nwbo has 5 booths, they have mentioned it on a few occasions.
Popps, that was funny. Same guy who got in a stock at .06 and it is now at .01.
R&D expense should drop once Rayaldee phase three is complete, and plus Opko finished the 4k study. 2013 R&D expense was 33 million higher than 2012 coming in at 53 million. I expect R&D to drop by about 15 million, which can help fund 4k roll out. Ended the year with 185 million cash, enough cash to fund current R&D, 4k rollout for two years. Cash is NOT an issue. Fully half of 2013 losses were derivative losses, no impact on cash.
Thanks but not much to say, everything was about what we figured, loss .11, revenue 23M. No horrible misses, no surprises, R&D expenses in line, but should drop over next two Q's, unless they initiate new ones, product launch in Spain and SA were already noted here. The savings on R&D should offset a large part of 4k launch, stock is acting like most earnings days, moving more with the sector than earnings news. Global launch of 4k even with moderate uptake could get opk eps. positive by q4, an outside shot at that. They noted Spain's revenue up but did not say if it was due to citicoline, but figure it had some impact. That will only grow over time, it has only been out there 4-5 months. So I guess those recent news releases were not earnings related, just Opko releasing news as it happened.