Revelations, of course! Interestingly, FDA has only 45 days to accept and file a PMA. Technically, that could be in just 2 weeks... it was filed beginning of Feb. Nothing to say Anika would tell us if it was, but they might feel compelled it it weren't? Sounds material like event.... Sounds to me that if it is accepted, it is a rather big deal in this case as it means Cingal will at least start its journey to market along the med device route.
Fact that Hyalospine got a CE mark was buried in this report is interesting, too...
Anika has made a lot of cash... and, on paper, a fair amount for me... so I like to at least consider the positives of what he says .. and doesn't say. At the same time remembering their record on guidance and other issues.
On the call, he says overall market share in US went up from 17 to 21%... implying sales up 23% on a flat market or 25ish% on a growing market. But Mitek sales! and maybe not sales, just "share"... and maybe not the full 4 points, given the fudge of 1-digit differences. A lower 3 point gain would be mathematically possible, too. He did not have to say that share gain, but he did. Certainly confused analyst Landy! But Sherwood has been using this inventory re-sizing for at least 12 months, now so who knows how to reconcile the likely 13% Anika US product sales growth with this almost double market share growth...
On the Cingal product Sherspeak was quite clear: it is Monovisc+... not much more. He said it met all 1- and 2-goals in a meaningful way, did not say in a significant way. So I'd guess it is short term better pain relief and long term non-inferior to Monovisc. So, combines two old therpaies and should not be a major problem for the FDA: claims will be very limited. As for partner, it is almost obvious it would be Mitek, after all it is Monovisc+... but he can't say that before he gets the milestones and pricing agreed.
Sherspeak guidance was ok: expect 13% growth AFTER B/L business goes away that means some 17% growth in the other businesses.
Yeah, someone else than the guy himself, and the Board and half the town. If. There is a slight, outside chance that the new CEO is, and remains, the boss of another entity... in other words the end game.
Well, well... that little meant more to the market than I thought. Maybe only naming the new boss will be what it takes to fill the next gap up..
Biggest news I guess was the confirmation that there will be a new CEO next week... a well-connected name might help. S Korea is rebounding, faster than China earlier - luckily distributor is picking up tab, mostly. Japan is likely not, since wasn't mentioned. Cash position was questioned. They burnt 10 m in 2014, but half of that was inventory and ar's - which should not climb with sales stagnant. Q1 might still be additionally hurt by own manufacturing snafu... but that should be a "one-timer".
FDA has halted US market progress...seems Staar got off to easy by having the Swiss site overlooked at the time. FDA doesn't exactly encourage firms to relocate to the US! No big issues, it seems... but then any issue is a big issue... and a huge distraction. Co. lawyer on the call prevented any meaningful discussion. Nothing on new product progress, since no-one asked...
If you have the direct veracast link handy, would you be so kind as to post... my browsers only show the link to the pdf... again.
Why? Because Sherwood said they were targeting 100 m in revenues for 2014, and confirmed that was the total amount in the last cc. The eps guesses were by analysts. The misunderstanding, if any, arises because Anika sells only to the Mitek stockroom. If Sherwood is to be believed, Mitek told him they had enough of the stuff in Q3 that they would order 2m less in q4.... so either Anika sales earlier were higher than maybe should have been, or Mitek got leaner... or someother reasoning. Looks to me that US ortho sales by Anika were up 13ish% for the year which is better than the market growth of mid-single to higher single digit told by Sherwood last q. The market "softened" in the first half due, likely, to the orthopedic surgeons' backlash
on the threat to their lucrative business! Some of that 13% was Monovisc, but not much... I guess.
Even if they had that missing 2m in Mitek orders q4 growth would have been meager without the milestones, but then again it was a tough comp? and anyway that's history - but shows they need a new product. That product is Monovisc, now J-coded. If they can get Cingal onto the market in 2016 and reimbursement in the US in 2017, things are set up nicely. And if Mitek want the distri-rights... that might cost them 50-odd m in milestones 2015-2017!
Market might see it differently, of course... and again what happened is nothing like what they were saying more than a year ago, especially on the European business, read Turkey/Italy etc....
Well as the last poster noted, I posed a question! Considering 10% of the co's value went after these seemingly good results, what do other not see that I do?
As for the negs. They got cash at 10.3, if you do the match - which tells you about the demand for the stock... as far as I can see biggest chunk went to a tiny Canadian investor. Going from basically data analysis to clinical oncology therapy with a "traditional-tech" management is about as risky as it gets.... and it was a huge commitment compared to the size of the company. But like I said thatos history, so it is not the cause...
Actually 2 really of note. The Beijing one could have been fluff, but now we seemingly have confirmation that the platform works from a second source... a US one. Furthermore the data will be publicly discussed. And to top that got an indicative timeline for marketing. All, or most, goes well, single-cell should be in full release by year-end? Although there is cash I would expect the burn goes up a lot if they sell direct. Market cap does not make sense, unless expecting massive dilution... that said, stock price was always saying that they would not meet the sales targets they set themselves!
Analysts have stayed away.. as have the more usual medtech investors. With this growth of 30%, past and forward, a company with 70%+ margins and more than nominal cashflow positive should not be trading at a forward some 2.7x or so of sales. Unless something smells.
Co. history is one thing, the huge, risky jump into therapy another, option awards at seemingly managed de-minimus price, the r/s, the badly priced capital raise are all there. But history is history. Given the opportunities, a 500 m market cap would be "normal" if this were a new ipo... which might be a nice stock price.
Up and down a bit more than normal. SPnc getting to be a much broader company with these new businesses: eventually they will be able to do the crossing, laser artherectomy, mechanical scoring, ballooning and drug treatment all from one salesman's bag. Nice when the insurance system can afford it! 2015E sales indicate a 5.5 x sales valuation... which could be a lot higher given the pipeline. Eps has been pushed out by many years though, so it remains to be seen whether they will need a stronger cash position. The projected loss is large but due to r&d. The guidance for lead biz was strangely weak, given the maybe 2 - 5 m missing from 2014. Of course this may be due natural caution given what happened last year!
Cos they bought much of the growth. If you look at the 2015 guidance it is some 10% organic growth in sales over last few quarters, but costs higher and maybe gross margin bit lower, too. CEO is good talker and Board has some clout, so market cap already high? ... can it be more than a 5xsales business...
That, too is true, just not backwards... Add that one to the list: gross margin increased by 5 percentage points to 41%.
For those who find this bit hard, let's recap. 2014 vs 2013:
Gross margin increased 61%
gross margin % increased 13.8%
gross margin increased by 5 percentage points
The big number, 61%, refers to the the dollars you can count - in this case the loss would be higher without them!
I think the valuation is crucially dependent on this gross margin growth number being around 50% for the next four years or so.ie annual some 35% sales increase and a gross margin % increase of some 11% in 2015. Until we get near the old target 60% margin for tests alone for a target installed base.. and technically a profit on current cost levels.
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!