My opinion regarding the article and the company's responsibilities with regard to it has not changed. And I'm not sure what updates on the gofundme site have to do with anything other than relating Jordan's general progress in recovery; and I didn't find the latest update "vague" in the least - Jordan is working hard on his recovery. The only cognitive dissonance around here originates with the people who think that they need to parse every third word to find some "hidden meaning."
The situation here is quite clear: Patient #1 is doing quite well, perhaps much better than expected; the FDA has let us take off the training wheels; and the company is doing precisely what they said they were going to do in terms of patient updates. Frankly, this is about as good as it gets.
If you are asking whether the NSS should make a significant difference in preventing encystment and scarring even within the guidelines of the current standard of care, the answer is "yes".
Same tune I've been singing for quite awhile now, nosticks. Every time this comes up I steer people to the statement Perrin made about patient updates. Don't expect them unless something truly extraordinary happens. People around here sure do fuss about the lack of PR's but then when they get one they don't bother to read the darned thing...
First time around we had fewer sites and more patients were excluded. It's reasonable to expect that this enrollment will take less time than the last one did.
Mid January is about right for the 90 Day Assessment, but "we" won't likely hear anything more than we did at the 60 Day Assessment, which was, as I recall, nothing.
I'm looking for an announcement that the company is submitting data to the FDA IAW the approved study design and an announcement of any material feedback that the FDA provides (now that we are pre-approved for Patient #2) but I'm not expecting any patient updates other than those that Perrin indicated that they would provide.
We should get a PR when the second enrollment phase opens in January and another when we actually get the patient enrolled (whenever that happens).
"Doing it on his own" and "Moving his legs independent of the use of his arms, trunk and hips" are two very different questions. SCI patients in rehab move their legs using other parts of their bodies all the time. It's an important feature of therapy to #$%$ the decline in tissue health in the legs and the potential catastrophic health consequences of that (stroke, thrombosis, etc.).
It's great that Jordan's general recovery is going this well, but what we are getting here is that the kid is really working to make himself better. And that could very well equate to a recognition of the Scaffold's role in reducing the impact of SCI.
I think we can be pretty sure he is doing it on his own, but from the sounds of it he is using his trunk and hips to move his legs through the water. Considering the nature of his injury and the fact that he hasn't been doing P/T for all that long, that's great news. The kid's a trooper, that's for sure.
Exercise in water is in common use in Physical Therapy because the action of moving the legs through water using the trunk and arms is very helpful in developing core and upper body strength while the body's natural buoyancy helps the patient fight the effects of gravity. For a patient with Jordan's type of injury building trunk and arms strength is crucial.
As a reference point, ISRG's margins run from 25% to 28% but they don't have to size and manufacture their products based on patient criteria. Our margins will be lower because our costs to produce each scaffold will be higher.
This isn't like a drug company that can run at 40-50% Gross to Net because they can achieve economies of scale on the production end. Mass production of the NSS just isn't feasible.
$9 Million isn't even close to what they will need for full commercialization; I 'm figuring that the warrants will get them from the end of the Safety Study to around the kick-off of the Pivotal Study. We burn around $3 to $4 Million a Quarter now with NSS being the only product in the pipeline.
I'm assuming a doubling of shares for purposes of outyear estimates because my thinking is that we will see more than one dilution prior to full commercialization, or else we will land a partner who will alleviate those costs in return for the lion's share of the net. NVIV is running on very low overhead right now, as they should be, but companies like this live and die by their R&D and that will be expensive.
First of all you NEVER price in "hype" - you simply cannot associate that with value. Secondly, 10% of the Chronic Market is huge. Remember that many people won't be candidates for this procedure because of age, general condition of health or other factors all of which tend to decline the longer they have been injured.
I went with the doubling of shares because the company is going to need a huge infusion of capital to get through the Pivotal Studies and ramp up to full commercialization. And a partnership will be worse, probably resulting in a revenue stream of only 30 to 40% of Net Sales (although they would "front" a lot of the costs of commercialization).
All told I think my estimates are reasonable.
First of all we'll be lucky to capture 30% of the Acute SCI Market. At this point we are only going to be an option for complete injuries and even among those there are many individuals who will simply not be good candidates. At best (based on a $100K per unit price) we're looking at $400 Million in gross sales. Once COP/COGS/SG&A get pulled out you're looking at maybe $20K per unit that can be allocated to Earnings on a non-GAAP basis. That works out to about $80 Million.
The company will need to raise capital sometime prior to 2016. That's either going to happen through a partnership or a Secondary. Either way that will dilute earnings significantly - my estimate is that either will cut earnings in half. Projecting a share count of 190,000,000 gives a non-GAAP EPS of about $0.42 per Share. Multiply that by a P/E of 30 and you're at $12.63 per Share for Acute SCI.
My calculations are that we will capture about 10% of the Chronic market or roughly 30K patients total - which could get us somewhere from the high teens to mid-twenties in terms of Share Price but I wouldn't try to count those chickens at all until 2018 at the earliest. And ex-US Sales are problematic, and I wouldn't even start to think about that yet.
Now, I tend to be pretty conservative with these things but your numbers are just far too high. That's the problem with "Bar Math" - too many distractions. Friends shouldn't let friends calculate drunk.
Monday 12/22: Jingle Bells, Jingle Bells, Jingle all the way; you really want to keep an eye on $13.75 today....
We're showing very low Volume this morning on Bullish Money Flow and low Volume days can be tricky. If Volume swoops in based on price movement we could go into Breakout mode. I'm showing the recommended Stop for New Short Positions well over $14.00 so there's room to run.
Ho Ho Ho!!!!
It's not "my logic". Companies have often responded to false statements of fact reported in the press and in social media. And it's not an issue where we're talking about matters of opinion, but only in the case of misrepresentation of fact. They are under no obligation to do so unless there is a reasonable concern for stakeholder interests and that's a matter for their legal representation to determine.
Well, even without the report this weekend it's been pretty clear that Jordan has been making progress but the company has stuck to their guns on protecting his privacy. They are under no obligation to respond to media reports in general.
If the report of improvement in Jordan's condition were not true an entirely different set of responsibilities would come into play and in my opinion the company would risk legal issues by not denying the story. My take on this is that "no news is good news". If the report is true, but the progress is within expected parameters then they are still bound by patient confidentiality and are within the guidelines expressed in Perrin's statement concerning patient updates. If the report is not true then they could be accused of a breach of fiduciary responsibility if they don't respond since there is an issue of fact involved. They have a fine line to walk here.
Investors have a "right to know" very little really, particularly when it comes to a situation where issues of confidentiality are concerned. In this case our "right to know" is bounded pretty closely by the patient's rights to confidentiality concerning his treatment for a severe medical condition.