Can anyone provide even a remote explanation as to how Brexit will impact a US drug company like DEPO? Probably not, but the momentum players will jump in and take any excuse provided - stupidity of the herd will dominate today!
not sure what you are looking at - the Form 4 filings represent option grants - there is a Form 3 from Redmile that shows them increasing their position?
He is missing the boat here - OMS721 won't start a "price war" - it will dominate the market. With a better safety profile - Soliris has a REMS (worse than "black box" safety warning) and requires a vaccine against meningitis two weeks prior to treatment - OMS721 will crush Solirist. OMS721 is already being used on a compassionate use basis in patients that haven't responded to Soliris. What doctor can ignore the safety risks with Soliris and choose it over OMS721 - they would be sued out of practice if a patient got sick or died because of Soliris and a safer alternative was available.
These gene therapy companies are a tough nut to crack from a valuation standpoint. There are two critical factors that are impossible at this stage to reasonably estimate - first, how long will the safety portion of a pivotal trial be and second, what kind of pricing will they be able to get for the treatment. The fear with these gene therapies is that they will create some sort of genetic mutation that will result in cancer or other "off target" side effects, so the FDA may require 2+ years of safety reviews before approving the treatment. The pricing is even more of a wild card - the value to the patient's quality of life and the economic cost is clearly there (e.g. saving a hemophiliac from routine infusions could save $300K+ per year), but will that warrant a price of $1M, $5M, $10M for these single-treatment cures - who knows? I have small investments in both QURE and SGMO, because the technology is so promising - curing people with a single treatment - but the time to approval and ultimate pricing issues (as more and more pressure is coming down on the industry) may not drive much value to shareholders. Gene therapy is really something the govt should be investing in and keep private industry out of it - it will save the healthcare system hundreds of billions if these treatments are successful, but all that value may just end up in the pockets of another healthcare company, rather than saving the taxpayers and those paying private insurance premiums any money.
The point is they have less than 6 months of cash left and will have to raise money soon - any pop from a Phase 2a trial cannot withstand the drop from a dilutive offering.
Yes, that was an interesting exchange about Firefly - you could sense that Arun was implying that NVDQ probably gave up too much to get SPY into ISRG's robots (their quarterly "partnered" revenues have been stuck around $3M for some time, despite increased procedures using Firefly?) and if ISRG wants to get the next generation of SPY technology and software, they are going to have to pay more than they are currently?
investor73498 - did you listen to the GS presentation - everything I said about Gala was confirmed - JC said it would take 6-12 months to "launch" (i.e. begin marketing) in most of the EU countries, as they have to negotiate pricing and other issues before getting individual approval - that is why the PR for the EU approval said it gives them "... a platform to begin accessing..." the various markets - they said two of the larger markets outside the EU (Japan and Brazil) will likely take even longer. He said it will take them until this time next year before they have a feel for the market potential in the EU. That is why I said you have to hope for one of three things over the next 6-9 months to drive the stock - a favorable ruling by the FDA on the US approval path for Gala, solid top-line data from the EB trial and/or solid early clinical data from the Pompe trial.
Of the three, I think the Pompe results are the least risky - lab data on the performance of ERT's translate pretty cleanly to the clinic. While the EB results will most likely be favorable, I think the "market" may not respond significantly, because they will not be final data - they are only a little over 50% enrolled and JC spoke to the fact that they are still increasing sites over the next 6 months (from 16 to 25+) in order to complete enrollment. They are starting to prepare a rolling NDA for EB this year, but EB approval is probably late 2017, at the earliest. The FDA guidance on Gala approval is the the driver that will be revealed first and the one with the most risk - any additional trial requirements will likely push the share price back to 52-week lows, before the prospects of recovery from EB and Pompe results.
Wow - your last statement confirms my point - if you believe Etep is as toxic as Drisa, your are off-the-charts stupid.
careful - BMRN BOUGHT the drug after the 100 patient trial "showed it did not work" because they looked at the pre-clinical data and early clinical data and concluded that the drug did work, but the P3 trial was flawed - they gave up the drug after the FDA and the EMA told them their drug was too toxic to ever be approved. Etep may have a "similar" mechanism as Drisa, but because of Etep's pristine safety profile, they are able to dose Etep at 5X+ higher levels than Drisa. The fact that you would bring BMRN in as a "logical" comparison shows how clueless you are.
As the company predicted, several hospitals using the T2 are presenting studies of their experiences - will this be enough to take placements in the 2nd half to a new level, or will hospitals continue to wait on the bacteria panel before committing to the T2? Lives are in the balance.....
The study period is only 90 days and the targeted completion date is Sep 30, so they would have to finish recruiting this month - probably a delay - see what they say in the upcoming presentation? The last presentation said Phase 3 data will be available in the 2nd half - also, that 100% of patients that have already completed the 90 day study period have elected to participate in the extension study, This is similar to the migalistat studies, where 90%+ of the patients stayed on the drug past the initial study period (many for years) - why would you stay on the drug if it wasn't working?
I'm not sure where you are coming from when you say Gala is the "value driver" - obviously, the market doesn't agree. The ONLY way Gala drives the share price this year is if the pending FDA meeting results in no additional study requirements and a quick path to US approval. If the FDA says more studies are required, the share price will likely take a significant hit. I am optimistic about long-term Gala sales, but it make take 3+ years for that potential to be realized. When it comes to the ERT markets, Pompe is a $800M market and Fabry is a $1.2B market, so they are significantly larger than the potential Gala market. When it comes to EB, the US market is between 15,000 and 20,000 patients - they haven't discuss pricing, but if it gets typical rare market pricing, it is at least as large as the Gala market and would be easier to penetrate.
I am long FOLD, but the wording of this announcement is as flaky as it gets "...provides a platform to begin accessing..." - the translation being that the US may only represent 30% of the global market, but it is going to be a long, complex road to access the remaining 70% - per their most recent presentation, the EU only represents 34% of the global market and it will take a while to nail down pricing and other issues with the major EU countries. Having said that, I think they might be conservative on what the market potential is - I believe they have gauged the size of the market based on current ERT sales and they have alluded to the fact that many Fabry patients don't start ERT until they have progressed or may not go on ERT at all because of immune reaction issues or the inconvenience of the infusions. Either way, Migalistat is not the short or long term value driver - in the short term it will be the EB trial success and in the long term it will be their next generation ERT in both Pompe and Fabry.
My obsession comment was directed at aeishh - he seems to have a hard-on about the CFO issue. No doubt, the CFO retirement is a strange situation, but do you really believe it is holding the share price back? If the company issued a clarifying press release indicating the CFO left because he has Stage IV cancer, do you think the share price would spike $2?
Again, you are assuming management incompetence with no evidence. Any decision to retire is inherently "personal" - saying someone is "retiring for personal reasons" is redundant - what other reason is there to retire? Your obsession with this issue is "scary"!
It is a privacy issue - they have no right to disclose the personal reasons behind an executive leaving. Your arguments are bungled - your previous post said they should have created the CMO position to "begin with" - really, hire a CMO 2 years prior to the product being approved for sale? If you are that disgusted with management, sell and move on.
You don't know the circumstances around the CFO "retiring", but you assume it is simple management incompetence. It is more likely a case of a health issue with the CFO or a family member - do you really think it was the CFO's intent to retire from a job after 6 months and he simply hid that from the company?
They hired a CMO in November, 2015 - the COO position was created in 2013, prior to them having an approved device for sale. Once the focus shifted to marketing, they needed to hire someone with that experience - obviously the COO did not have the marketing skills/experience. The reason to bet on this company is the technology - shifting management roles/people are not material to the long-term value.
I appreciate the sentiment, as OMER has been a big chunk of my portfolio for the past 4 years, but your spin is not very realistic. First off, if management "learned" about the seasonal conference issues in time to train the staff, then they had time to provide investors a heads-up on the seasonal softness in sales - the didn't announce Q4 results until Mar 8th and the obviously knew about the slow start to Q1 and decided not to disclose. That is part of the reason the shares tanked - the CEO is hiding things - instead of disclosing what is going on, he hides behind platitudes. Secondly, There never was or should have been the risk of a "large dilutive secondary", so the idea that we have been spared that risk by management's nimble actions is a joke. Assuming they need the full $20M to get to cash flow breakeven, that would have been a 5% dilution using the ATM at $10. Finally, the idea that they are holding out for the "perfect" EU partnership is ridiculous - the patent clock is ticking and any potential partner's willingness to pay a higher cut to OMER is dwindling along with the period of exclusivity.
If you want to tout management's launch of Omidria, I'm on board - the way they established and tested reimbursement to ensure docs would have no risk of coming out of pocket to even test Omidria before they launched was critical and they nailed it - if they hadn't done that, docs may have bailed on the drug before even figuring out if it worked. Beyond that, I have not been impressed with management - if it wasn't for the potential blockbuster value of OMS721, I would have bailed by now.
The original loan agreement specified they needed to hit $70M of sales in calendar 2016 in order to get access to the remaining $20M. Obviously, management entered this agreement predicting they would be cash flow positive by "mid-year" and that they wouldn't need the extra $20M to meet normal operations during the year - they failed miserably on that prediction.