Good info. VRTX won't say this level. This drug will generate billions for sure and profit margin is very high as well.
Given new break-though treatment, politician will not come on way. They would look coming in way for Innovation. End of day, this is good stock to own.
Sentiment: Strong Buy
1 continued) Approving a med that is extremely safe and for a population with no other treatment will be a feather in the administration’s cap. And those are two other reasons: The drug is extremely safe and there is no other treatment available for those Cfers and it will means several years waiting otherwise. Finally, Vertex’s assay has a proven record of predicting clinical benefits, making its drugs the perfect candidate for approval based on in vitro.
2) The Phase 3 for 6-11 was significant for two main reasons beyond the obvious that it will be approved in U.S. The results of the lung clearance index indicate the EU study will also be positive and support approval as the results were -.8 and the target was -.7. Second, the results were positive enough that some parents who might not considered trying or doctors who might not have scripted, will be more likely to with the 2.5 FEV improvement and the -.8. That will support a faster uptake for 6-11.
concluded: 3) The comments (and lack thereof) on Phase 2 next generation imply that the trials in healthy volunteers are going well. Remember: Vertex in prior conferences stressed it had more next gen correctors to go into clinic, but said nothing about that this time. If the results are looking great, there is no reason to add more to the clinic. Vertex already is thinking of multiple doses for BOTH correctors for phase 2. It knows the preliminary results and they must be good for both to comment on both going to phase 2. Vertex stressed that it took to clinic drugs it believed could be made into a drug, not just had good results in vitro. Again, Vertex knows already how the trials are going and wouldn’t have made that comment absent a belief they will go forward. Vertex stressed that the longer it takes to get to Phase 2 the better because it is an escalating dose trial and that means they are able to increase the dose and get higher exposure without problems and they’ve obviously been doing that for 2 months already. All boding well for the next gen correctors. And Vertex’s assays are highly predictive, which means the triple will reach het-mins and get heteros to 70% (Kalydeco only got g551 to 50%).
In Vertex’s earnings call, there were several significant points which the market does not seem understand...if it did, the price would have skyrocketed.
1) The residual-function sNDA will not merely expand the Kalydeco label, but if approved (which I believe it will be, for reasons noted below), it will provide a basis for a quick expansion of Orkambi. As Vertex noted, the sNDA presents both a scientific and a policy question. The science it believes is solid to support expanding to cover residual function. The policy question is how do you handle rare mutations where there are only 6 or 10 individuals who have those medications. As Vertex noted, this is the issue presented with “precision medicine.” Once the sNDA is approved, that is the green light for expanding gene-based medicines based on in vitro evidence (or possibly a small, short trial). This provides the potential of thousands of more Cfers on label for Orkambi (and later 661 combo) fairly quickly. There are about 2000 different cystic fibrosis mutation and the het-min trial is only looking at 120 mutations, the residual function at 27, and the gating ones are around 20. That means there are a large number of other mutations (1500-1800), which likely show some in vitro response to Kalydeco or Orkambi. (Vertex will have in vitro results for all the mutations.) In other words, there are hundreds of mutations that like ddf508 will respond to Orkambi. Once the FDA green lights the sNDA for residual function, the next step will be to reach those who will benefit from Orkambi.
So this why I think the FDA will approve the sNDA: It has not set a meeting of the pulmonary committee and I do not see the FDA rejecting the application without a committee reviewing it and there isn’t time to call a committee meeting before the action date. Obama’s state of the union stressed precision medicine with a Cfer in the audience. continued.
24/7 Wall St. also has a similar idea, Q. The report is difficult to open. So quote it below.
[[ Vertex Pharmaceuticals Inc. (NASDAQ: VRTX) recently had its cystic fibrosis treatment Kalydeco (ivacaftor), accepted for review of a supplemental New Drug Application (sNDA). The FDA granted Vertex’s request for Priority Review of this sNDA and a target review date of February 6. This could be a turning point for Vertex, as the stock has gotten beaten up over the past couple of weeks. Shares ended last week at $90.75, with a consensus analyst price target of $140.25 and a 52-week trading range of $81.98 to $143.45. ]]
holding VRTX right now is a mistake, it's going much lower...
plus, you got lucky when they got their FDA approval. Without that, it would be 20 now.
Don't mistake luck for good investing.
To think lightening will strike twice for you is a little overly optimistic. It could be that public policy dampens biotech for a few years.
Estimates also get revised up as well, depending on news flow.Let's see what happen to these estimates on Feb 7. They will likely go up when 1500 more CF patients with residual function mutations in the US are approved for treatment with Kalydeco monotherapy. Represents 400+ million more in revenue. Factor in approval of 2500 508dd CF patients ages 6-11 likely to be approved for treatment in the US with Orkambi later this year, and you can double that additional revenue number over the next two years. This is on top of the continued adoption of use of Orkambi by the great majority of 5088dd patients approved for use in patients ages 12 and older in this country and the EU and Canada. Election rhetoric about the cost of pharmaceuticals will die down after November, and if Republicans maintain majority control of the House, it will not likely translate into any legislation to control drug pricing which would crush risk taking destroying advances research and innovation in medicine.
Average up is successful until you learn one day bomb wipeout everything. My strategy is Average Down including slow selling when price start going up. This way I can buy back when go down.
I have VRTX with average down into $40 3 years ago. Company start going up and I keep selling and keep limited share at $130. Now price go down I able to use that cash to buy more then sell on single day for 8% profit and keep 1/8 of share which has same average as my other ($40 discounting 1day profit)
Now if you think this is disaster strategy than everyone know how much you know about investing.
Sentiment: Strong Buy
Here's all the knowledge you need to know what to do with VRTX:
In the last 90 days, the eps estimates for 2016 have dropped from $3.60/sh to $2.65.
2017 has dropped from $7.42 to $5.98.
I never buy a stock that has declining sentiment, and one of the most important components of sentiment is the eps estimate.
While the SP seems very cheap from a recent history perspective, I suspect it is going lower. A BO is the only way, imo, the SP goes up.
wow, I am truly jubilant to see such knowledge displayed on a message board. This is something you rarely see. You have given me hope that the world is not full of idiots and I mean that sincerely. Now, if we can only get the stock to start acting better.
As you may be aware, Vertex is quietly developing cancer drugs: three of them VX 970, VX 803, and VX 984 in clinical trials. They are inhibitors of DNA damage repair, and most effective when they are given together with DNA damaging agents such as chemo and radiation. In 2015, they estimated, there were 1.6 million newly diagnosed cancer cases in the US and 600 thousand of patients would die. About 2/3 of all cancer patients would receive radiotherapy in their illness. I highlight the above drugs as effective sensitizers to radiotherapy because radiation, particularly high energy radiation, is an effective DNA damaging agent, and can be delivered to (and focused on) a localized tumors without seriously damaging surrounding normal tissues.
Vertex is recruiting and also 'not-yet recruiting' participants to multiple clinical trials for VX 970, and some results will be available sometime this year. Both VX 970 and VX 803 block damage repair by allowing the cell division cycle to proceed so that damaged DNA leads to broken chromosomes. VX 984 blocks non-homologous end-joining repair, being an inhibitor of DNA dependent protein kinase. Chemo or radiation alone cannot kill all tumor cells, but there is a chance that they could kill almost all tumor cells when used with above sensitizers. Any remaining tumor cells can be mopped up with immuno-oncology drugs such PD-1 or PD-L1 inhibitors. Chemo and radiation would remain the first line of battle against tumors for a long time. About 1 million people would have received radiotherapy in 2015. Both radiotherapy and chemo are expensive and they better be used with sensitizers to make them effective.
"I didn't predict price whether it will go up or down."
"If it success this stock will reach 100 "
Make up your mind, pls...
Never will RLYP get to even 50.
At 100, it will have a mkt cap of about 5.5BB, accounting for the current shrs, and the additional shrs it will offer later this yr.
To justify that kind of mkt cap, they would need revs of about $1B.
This yr looks like 46M. Plus, and don't forget this, they are burning thru 60-70M/Q, which means by the end of 2016 they will have spent 275M to get 46M in revenue.
So in 5 yrs, maybe, the rev could be 600M, just a guess, and they will be spending, in 5 yrs, at least 400M/yr.
$100M in profits at a 20 PE gives you a mkt cap of $2B, or a SP of about 35.
You are either very poorly educated, or someone who doesn't use English as a primary language. I'll go with that.
Regardless of language, you know nothing about investing. There are no investing books that tell you that averaging down is a good idea. Cramer says that, are you learning from him? Well, he only recommends very large cap very strong stocks, with little volatility.
Averaging down will lose all your money, my dentist averaged down in the oil stocks, I told him more than once that oil was going to 30 or 40, he lost a bundle.
Averaging up, when things are in an uptrend, is successful investing.
If you were in bios for the last 6 months, and "averaged down" vs selling everything, you lost your shirt.
That's bcse most bios have almost no real value.
RLYP no no real value. How much would you pay for a business that's losing money faster than they are growing sales?
The current mkt cap is 785M, current fcsted 2016 rev is 47M, and 2016 loss is 4.20/sh. A LOSS OF OVER $4/SH!!!!! And you will pay 18/sh for a stock losing that much?
In 2016, they will have to do another SO. Unless they demonstrate revs will be MUCH more than 46M, their mkt cap really shd be closer to $500M, or even less.
The idiots who say 45 looked at the ZSPH deal. That is history, not gonna happen for RLYP. CELG invested in AGIO at 104/sh, it's 40 or so, is AGIO worth 104? No.
So my tgt for RLYP is 12-14/sh, unless they can clearly show that they can get revs to more than 46M this yr, and well over 100M in 2017.
Clear enough for you? The best reason I hear for it being higher is bcse someone else paid more for someone else. That is a very stupid reason to own a stock.
you need to explain why you think it will drop 30% just because it drop 30% in last 2-3 week.
I didn't predict price whether it will go up or down. You are predicting here. Infact when i start investing, I plan on how to average down if it go down. Mean not all in when buy.
With regard to Drug product. FDA don't approve product if it not working. In Market place whether it success or fail determine later. If it success this stock will reach 100 without buyout. If fail it might go down to 0.
Sentiment: Strong Buy
"RLYP is great stock..."
You must be some kind of genius, pls explain to me how a stock that's down over 30% in 2-3 weeks is a great stock! That would really be something I can learn from!!
RLYP might be back to 30 in a month, but I bet it's closer to 12 in the next 4 months...
Shorts aren't hurting We've been making money for a while now. If you happen to short at 81..... just hold it long enough and you'll turn a profit. This company does not have the ability to sustain its bloated, price gauging dependent market cap. Cheers!
I bought and sold a few times since the last 2 weeks and made a few $$$ per share each transaction but I missed the $81.89 price point this morning because I was still sleeping (could never thought it could go down that low in one session). I saw the $87.55 but I did not buy because GILD, CELG, ABT, PFE, MRK, NVS were tanking so I took the wait and see approach. Shortly after, I bought GILD at $87.8, PFE $30.3, MRK $49.05 and almost pulled the trigger on CELG at $96.05.
I think biotech is in a bear market right now so I will buy VRTX when it drops to the 70s and monitor GILD, CELG, AMGN for a while longer.
A very wild ride today from $91 to $82 and back :) good luck to all VRTX share holders.