I dont think its light years away and here is why. OPK clearly will not market the drug based on Frost's comments about OPK being a Renal and Urological focused company. This is a drug they would license. The HGH licensing happened on phase 2 data, with the same technology platform (although slightly different than HGH - peg). Phase 1 initiates this year. If OPK does a phase 2, thats two to three years and we could see a licensing deal. I think this is far less than light years. Years later are the drug sales royalties.
I agree, and thats based on US 12 billion market alone. Then read Burnaka's post about global sales outside the US.
I am watching closely for progress on Oxyntomudulin, its gonna be HUGE ... sorry couldn't help it, ya know the Fatso Drug.
I think the answer may be somewhere in the middle. I agree with what the definitions of Priority review and SPA are. However, if a Standard review normally takes 10-12 months, with or without an SPA, one should assume that with an SPA, it should take less time than a review without an SPA. A review with an SPA does not need analyze the design of the trial and validate the approach from scratch. This work has already been done. They only need to validate that the SPA was followed. This should take less time than a complete bottoms up analysis. I am sure they do not advertise any time reductions, but that what I think.
While Rayaldee could be considered a me too drug, the side affects of Calcitrol are such that they are not prescribed at levels needed where they would be therapeutic. The risk is too high for most patients with CKD. For these patients one could argue an orphan status for Rayaldee since the existing treatment is barely affective with an acceptable level of risk.
Interesting, but sadly, not shocked by much these days. LH made a jump at the same but settled down much faster. Not holding my breath for the SEC either.
Frost has not bought in how many days? Now... what could OPK license to both companies that would seriously increase their margins and improve the service to the customer? Hmmm?
Would love to see that deal
First of all, thanks for the post walstreetguru. I have thought about posting something similar, but as this post proves, for the most point, why bother given the reaction. Anyway, I put this together as a back of the napkin in the Summer of 2013 from OPK's Jeffries slides. That means this does not include Inspiro, Oxytomodulin, 4kScore, and EirGen
Looking at the slides from the Jefferies conference OPK states the following as market share:
All phase 3. Not sure if market numbers are global or US only
Claros 1 - US Market only
Vit D 3.5 bn
No Market numbers provided for 4kScore so not included here , a big gap
A 21,475,000,000 market described
Assuming a 20% market share / penetration across the board, which is a very broad brush and will obviously vary by product, this produces
$4,295,500,000 annually for an eps of $10.38
Amgen 14.5x 2014 to 13.5x 2015 earnings
Gilead 18x 2014 to 12x 2015 earnings
Biogen Idec 27x 2014 to 22x 2015 earnings
Celgene 20x 2014 to 15x 2015 earnings
Valuation of OPK @ 10x earnings (with of 20% market) to be conservative $42,947,250,000 @103.8 per share
Of course the operative question is when would OPK achieve these levels of market penetration? That I do not presume to say I have any idea about. But I think the pipeline can definitely support $100 and with Oxytomodulin alone, should it be successful and licensed could be much higher.
My two cents... fire away or not. Everyone is free to use their own rationale on market penetration, I think I was conservative, and the same for valuation x earnings.
I wrote back to confirm the meeting time and was advised today that it is "tentatively scheduled from 10am - 11am" on June 18th.
Miami, sorry for the confusion. Tickets are purchased are airline tickets to travel to MIA for the day. Have the meetings in the past been scheduled for 6 hours through lunch ( I assume there is a lunch break ) ? Thats the only thing that seemed odd to me to speculate about.
Burn, I have been wondering about this as well and agree with what you say. But, I cannot help but wonder if eventually it could be. Example, the Vitamin D council is suggesting 10 to 20 thousand units per day may be too low. As a supplement 20k units per day may be ok, but they say that pharmacological levels have yet to be established. Thats several pills a day and potentially multiple times a day. Which makes me wonder if Rayaldee for some other purpose than CKD could be prescribed at lower doses than used for CKD with its slow release formulation requiring perhaps a single pill once a day rather than 2 pills twice a day (if 5k units per pill, the ones I have now are 2k, so thats 5 pills twice a day if you want 20k units) Possible?
I contacted Opko to confirm the date. The next OPKO Board & Annual Shareholders Meeting will be conducted on Thursday, June 18th, 2015 from 9:00 AM – 3:00 PM at 4400 Biscayne Blvd. Miami, FL 33137. They advised that if you’re planning to attend, to please give them a call a week before the meeting to confirm that the schedule remains unchanged.
Always wanted to attend. This will be my first. Tickets are purchased.
Who else is going?
Sentiment: Strong Buy
I have noticed that the early pre-market action seems to correlate to the TASE. On Fridays, when the TASE is closed, pre-market actions appears to be very low.. Any chance TASE trades are picked up as pre-market trades on the NASDAQ?
What is unclear to me is if for non CKD people, that over the counter vitamin D could not provide these benefits. In looking at the vitamin D council's site, they discuss toxicity levels by measuring high calcium in the blood. But they are talking about over 300,000 IU per day for 3 months for these levels. Maybe the calcification risk is much higher at these levels for CKD patients vs non CKD patients which is where Rayaldee does its magic by not raising calcium levels. The article eludes to "pharmacological" doses for vitamin D. To me, whatever that pharmacological dose is and at what point for non CKD patients benefits are achieved due to the increased dose without a rise in calcium blood levels is where the potential lies for Rayaldee. Will be interesting to see.
Sentiment: Strong Buy
Off label uses of Rayaldee beyond renal / CKD, which there are initial studies for, are what I think will happen sooner than later. I agree that Oxyntomodulin will take some time to gather the clinical data that ensures it value in any future deals, but it likely gets licensed too according to what PF said.
Sentiment: Strong Buy