I have the same questions. Since Sherwood has not been very open about it, I have assumed that Cingal has a short-acting steroid and the longer-acting HA... effectively adding two accepted treatments together. Not revolutionary, just practical. It's been done in practises for years. We know that long-term steroid use has its down-side in the spine, but then again look at nasonex use, or then these new steroid stents - they have not had negative fda issues.
From what I've read, the HA is anyway the restorative compound, not the steroid. Difference to Flexion is then time-proven safety non-issue of short action... and that equates to no need for multiple p3 trials.
Nothing much to lose here! Or then maybe there is: if they start a US confirmatory trial, fda might just say we'll wait, but if they don't and fda says no, they are way behind the competition.
In 3m or so they need a deal or cash again... nothing new, question is at what price. Mid-point of growth is the Q4 growth... or 35ish%. Not bad, and meant to be beat, but not quite accelerating vs 2014 unless you take a higher point. Gross margin is the key, I made that up 61% over 2014. They need to increase that by near 50% in 2015... requires another round of re-engineering.
Anika has known the Cingal trial results for a while... so long that they filed in europe some 6 weeks ago. What we don't know are the endpoints! The key one being non-inferiority or superiority.I doubt they would get a PMA on non-inf, but I am not sure they wouldn't try... just to find put what the fda wants. This is short-circuiting Flexion by a mile...market not impressed, yet.
This was a 483, which is kind of normal... until it isn't. There may be 10 items, but only 1 that requires action. Staar has form with the FDA, we know that... and the FDA like to go to California in winter...
Any phase 1? study in acute stroke awaits results of another study not due until 2016... mid or whenever. Someone need to take this program or the company out and stop management seemingly playing for time to seemingly maximize their own benefits!
Tape says there was a step down late Dec, and another post the warning. One gap filled, and a bit more, in a week. The first gap, more a slide, could have been the FX but not all: now we know they were missing "usual" stocking orders. Assuming they arrive with a delay.. and the declining FX effects "stop" , there should be room left to recover. Then there is the other bigger stuff, like demand. The Lasik business doesn't sound too great: previous owners bought back LCA for 40m, 90% less than the pre-crisis value of around 400m.
Scripts are the ones to watch for us, but looks like total tablet sales are some 4% below a normal rate? Anyway, weren't we told that the docs don't like to change a working treatment... so B gets to be prescribed to the new patients.. and those with issues. Slow road!
The other rule is that you raise capital when you can, not when you need! Another "law" is that price goes up when the potential dilution overhang is removed for a while.Like mot businesses that went public via r/m, this co is cash poor... still.
Looks like ceiling: same pricing as last time! only that was to shake some stuff off. 20% dilution again now ... so we really need that growth. Price all the cash and debt as shares and we got 18 m new shares equivalent from around 18 previous so all told 50% of the co gone! History now though.
Almost said big boys'... Axogen needs the cash backup, just in case. Announcing the intention, without date, at the time of the sales figure takes out some volatility, which is good. And stock needs hi-Q investors.. now and later... unless there is a buyout. There is a small float and it is in unusual hands. Stock and company could do very well as an independent... 50-60% growth isn't seen everyday! but got to fix the basics first.
In the interests of fair trading:
ClickSoftware expects 2015 revenue of 140-145 million and adjusted earnings per share of 15-9. Market expectations had revenues of 142.4 million and adjusted earnings of 11 cents per share, the Company's expectations slightly better than market expectations on the bottom line and are in line with market expectations on the top line.
In a conversation with "Calcalist" said Moshe Ben-Bassat, CEO that "The fourth quarter was very strong and most profitable we bypassed the lower range of the forecast. We own revenues slightly less below the forecast and the reason is rejected two major deals in Russia because of the crisis that was there at the end of the year. " (interesting addition not on the cc)
"Overall we are gaining momentum awesome. We signed only this quarter 22 new business and typically several new transactions is lower, then it shows the momentum on several levels. The first level is the subject of the service only grows everyday and utility companies are facing pressure from clients And that's what our systems do. We did a fantastic beyond our technology with cloud computing and this is reflected in our winnings. I want to believe this momentum will continue in 2015 if the global economy will remain at this rate. "
As for the sale of the company said Ben-Bassat that "we're getting very beautiful and we are at the peak of our growth and our very strong competitors disappear. There is no intention to sell the company".
This is not an auction... i'd say that is a journalist's guess. To the buyer, they have synergies a stand-alone co does not... form GE days it was 20% - minimum! Anyway, it is the Board that decides, and decides to start the sales process... now it is started we want the max no. of bidders... only then do you get the right price!
So we see: Haartz: ClickSoftware, the Israeli company whose software helps companies better manage their workforces, is putting itself up for sale and asking $300 million, a 25% premium on its Nasdaq-traded share prices as on Tuesday, TheMarker has learned.
Piper Jaffrey has been selected to manage the sale of the company, which has offices in Petah Tikva in Israel and California and employs 300 people. The company declined to comment, saying it doesn’t respond to unverified reports.
The sale won’t be the first time ClickSoftware sought to market itself. Several years ago it began contacts to be acquired by the German business-software company SAP but they didn’t lead to a deal. Yet Sergey Vastchenok, an analyst at Oppenheimer & Company, said the company’s move into cloud computing improved its chances.
Analyst expectations, that is. Not very demanding on the eps side, though, bout same as just this q4. Profitability is actually a lot better- but then it was, but currency likely plays a role. Let's see if market looks forwards or back, or is sceptical!
Compared to trabeculectomy to increase aqueous humour flow out, slowing ah in the first place would seem equally good. This is a much less invasive procedure, too. And faster and cheaper and safer. It's been done before, after all this is a 510k, so I guess the idea here is that micropulse just makes it a little better and maybe a lot safer.
Let's hope. for sure Sheri leaving is no co-incidence to what is really happening. I mean, really! Smells like somene wants her out of the way.... which is a big deal for the largest holder to swallow, I'd venture. IF someone is appointed, though, that means no sale...
An ipo trying for 200 m valuation. Seems like Monovisc+flexion, ie cingal-kind of product. If these peddlers are doing their sums right, these two are worth 500m+ together, before any approvals. Cingal worth zip?.. or an extra 30 a share on that basis!