Still expecting it to get closer to 80-100%, do not pay attention to the CLOWN, 15% in a quarter growth is excellent, as is 60% in a year.
Also note cash on hand 134M, cash burn of ONLY 22M, LAST Q cash burn was 29M, so cash burn dropped by
7 million dollars. That is good news.
The 25.5 loss " COULD " read 10.1 less but they chose to take an R&D charge of 10.1 for the purchase of Inspiro. All in all earnings, cash on hand etc., in line or better.
Pharmaceutical product revenue for the three months ended June 30, 2014 increased approximately 15% to $21.4 million compared to $18.6 million for the 2013 period. This increase was principally the result of increased revenue from OPKO's active pharmaceutical ingredient business at FineTech as well as increased pharmaceutical product revenue at OPKO Spain and OPKO Mexico. Total revenue for the three months ended June 30, 2014 was $23.5 million compared to $23.8 million for the 2013 period. Total revenue for the three months ended June 30, 2013 included non-recurring revenue of $2.0 million related to OPKO's transactions with Pharmsynthez.
Net loss for the three months ended June 30, 2014 was $25.5 million, compared to $3.4 million in the comparable period of 2013. The increase in net loss was significantly impacted by an $8.5 million gain related to the successful exit of a strategic investment in the three months ended June 30, 2013. Net loss for the three months ended June 30, 2014 included $10.1 million of non-recurring expense related to the write-off of acquired in-process research and development expense related to the Inspiro acquisition. OPKO continued to increase its investment in research and development activities during the three months ended June 30, 2014 related to its ongoing Phase 3 programs for Rayaldee and hGH-CTP. As a result, OPKO's spending on research and development increased $6.7 million to $16.2 million for the three months ended June 30, 2014 from $9.6 million for the three months ended June 30, 2013.
For the six months ended June 30, 2014, pharmaceutical product revenue increased approximately 21% to $41.2 million compared to $34.1 million for the 2013 period. The increase in pharmaceutical product revenue was principally the result of increased revenue from FineTech, OPKO Spain and OPKO Mexico. Total revenue for the six months ended June 30, 2014 was $45.8 million compared to $55.2 million for the 2013 period. Total revenue for the three months ended June 30, 2013 included non-cash, non-recurring revenue of $12.5 million related to OPKO's transaction with RXi, which was partially offset by increased product revenue.
No firm date, there are two identical phase 3 tests going on, one is complete. The other maybe another couple months. They then will get paper work together and submit to FDA, THEN it is at the FDA for MONTHS. SO they submit in 2015, by MARCH, will hear back by Late 2015, or real early 2016, then they can sell
Phase 1 to phase 3 is roughly 10 years to get an approval. So when YOU see phase 2, it is roughly 5 years more. Phase three start to approval 3 or more years depending on the study, but this is on average.
OH, ps., phase 3 results and then needs FDA approval. Hope you were kidding asking that, you play in biotech, you need know this stuff. Well OR be a GREAT CHARTIST. U do rely on charts, so, if it works.
I am putting the cart before the horse stating positive p3 results positive, opko has said nothing yet. However they did state they are going ahead with a whole new trial, for a different indication with the drug. Reading between the lines here, but I figured that meant Rayaldee met all end points in this study which they will announce after the close. I for one do not expect much of a POP on the news, but hope I am wrong. I think consensus is the drug will not be that big of a money maker. Frost thinks it will generate well over 1 B, time will tell who is right. Regardless, I do not touch that position, IT IS a multi-year, now 3 year hold for me, will hold through 2016 minimum.
U might try calling opko's medical lab, they might have word on insurance carriers. I read HERE for what is worth, ( maybe nothing ) that at least one insurance company was covering it.
4k will take 12 to 18 months to get full insurance coverage, so that is a known. The sales forces is growing, but there are still many areas of the country with positions open. 4k will continue to roll out but it will be SLOW for the first year, do not expect much until insurance kicks in and the sales force is in place. To get 4k up and rolling is a BIG project, FIRST, they need the sales force, then they NEED educate the Drs., and throw in the insurance issue, it will take time. I expect 4k sales under a million, a drop in the bucket. If they even have 1-2 million in sales I will be surprised, it is too early in the game to expect more.
Orphan status is basically meaningless until a drug is approved. Nice to get it because it holds off generic competition for 4 extra years, but getting the drug approved is the issue. Arry appears dead in the water right now, needs phase data to get it moving. Some Orphan drug announcement might have popped it a dime, or even a quarter, but nothing sustainable. Need top line data here to have any impact.
Earnings call, 8:30 am Opko, 9:30 am arry 8/12/2014.
Opko will have a loss in the .07-.12 range as expected, Rayaldee phase 3 was a success, not sure if Rayaldee news moves the stock. Frost thinks over 1b revenue, LW, 35M, my bet is on Dr. PF.
Retail shorts get an invite to the barbecue by the hedge funds, unaware they are the menu. The hedge funds will use them to toast marshmallows.
In a healthy person, OTC D, though it degrades quickly, the healthy person will absorb and store some D. Over a few months an otherwise healthy person can build D to satisfactory levels. I have read this can take about 6 months if they start out severely deficient. It is my understanding that with Rayaldee the optimal level can be achieved and maintained within two weeks. So it might be where Rayaldee is used for a month or two to clear up symptoms of D deficiency, then an OTC for maintenance. Just a thought.
That is my understanding. After two hours OTC is basically out of the body, you would need take pills every two hours, 12 times a day to get the benefit of Rayaldee. Rayaldee level can be controlled by raising or lowering dosage to keep D at whatever level is considered perfect. No arguing that people with healthy kidneys can utilize OTC, or convert sunlight, but can those options be monitored properly to achieve maximum benefit? Those options at best would be hit or miss, or require a heavy pill burden. If a patient absolutely NEEDS vitamin D, and needs it at a specified level RDEE is the only real option. Insurance payments, and possible conditions is a whole different issue, I leave those to Frost, and the fda. Vitamin D affects things like calcium, and phosphorous levels which have roles in brain function, and bone condition. Too little D and you can get an imbalance just as too much creates high blood calcium levels.
That is the untouchable advantage RDEE has. It can put D at a steady level, 24/7, no other option can do that.
Google an article, the benefits of sunlight. Trees make a chemical for their survival initiated by the sun and uv rays, humans do too. Nearly every disease in humans has a link to lack of sun exposure. OUR photosynthesis. The deal with RDEE is it can get the level perfect, and keep it perfect year round, I agree with your initial thought BUT OTC degrades in to useless in about one maybe 2 hours. ANYONE regardless of condition, NEEDS CONSTANT steady D like we got before clothing prevented natural absorption. Time will tell, but it is a big drug. Funny is if we went naked, danced around a fire, no drugs, let alone artificial sun light.
anyone who shorted after June 17 is using a snorkel or covered and is licking their wounds. Price goes much higher a snorkel will be of little use, crazy to hang on to an anchor while swimming up stream. Need volume to pop through 9.50, it will happen sooner than later, retail shorts get roasted AGAIN. Funds do not care, they can hold a loser for years, or cover and make it up elsewhere, it isn't their money anyway. It is just one bad trade, not a margin call. The clowns here it is a different story, but as long as there is a tree in a park somewhere, you have a home, and Brian as a roomy.
Nice if we get another 8-9% move, or better.