The renewed orthovisc agreement runs out in Nov 2017... so needs renegotiating end of THIS year. Anika would be mad not to use all the tricks to get a better price and terms: it's "our" brand" after all and they get it for a generic price. I'd say jnj get the lot at a higher price in 2017... However, Anika would use the profits to market its own other products - which would eat up the benefits?.At this rate cingal will not be on the market until 2018, if then - if another trial is demanded - so timing isn't as sweet as it seemed in 2015.... Plan B would be to take back all rights in 2017 ... sure they would lose sales and share for a while but the profits are staggering even on less sales. Plan B is high risk, but also puts the company in play - at the moment it can't be because of jnj.
I am more worried about the fda relationship than direct sales!
Well, someone got nervous, but the marketer jnj was upbeat for this quarter. More than sales, people wil want to hear how cingal is doing vv fda. Clealry no actual progrees as no pr yet....jnj:
"Orthopedic sales growth was driven by worldwide knees and hips and U.S. trauma and spine. Market growth and the success of product launches drove results for the U.S. orthopedics business. Pricing pressure continued across the major categories, partially offset by positive mix for trauma and spine products. The success of the TFNA nailing system in trauma, the ATTUNE platform in knees, our primary stem platform in hips, and ORTHOVISC/MONOVISC and new spine product introductions made important contributions to results.
They are spending 5m a quarter even before the trial starts.. expect rd to double when trial starts - so that is 30/ year for 2 years with 20 in cash now. Numbers do not add up. At minimum an interim look a year into the trial would attract. The drug method and indication all look fine, unfortunate situation.
So far -7%... or then back to where we were before so: plusminuszero. So far, data shows non-inferiority to in.pact, in real-world SFA. What we were not told is bail-out stenting rate, etc. Most important would be better function, is 84% better or even meaningful?! Less drug is safer, but needs a good end result, too in SFA. So far, all else has failed to improve on plain balloon in BTK, so if Stellarex has the right trade-offs there, then it's all worth it. At least the lead here PRof. Zeller is the most critical in the business, so i think we can trust the numbers, if not the spin. 2 days til chance to ask questions is a long time...
Showing fairly good results. This earlier data were from a very small group at 2 sites,so this result de-risks the program big-time. As to whether the dcb works better than in.pact... hard to say. The Medtronic trial results were from a "manipulated" trial and were not so great in the real world study. So what's new. Also,functional benefit was no better than plain PTA... but the latter requred reops. This release says 84% walked farther, but not by how much. The in.pact study showed that at least for their's the critical period was 13-15 m... during whic there was a step fall off in effectiveness. Hopefully, with no mention of MACE or mortality, safety not an issue. In the medtronic case mortality was overlooked in approval. Looks goo, but all the bad stuff happens in the next 12 m, if it happens!
Consider, though, the time gap from now to then.... itwillbe 4yrsbefore they are selling the new drugs in the pipeline. As for cash, that's why a merger is the best option. Synergies would be huge, if it works out.
As an ex Applix shareholder, quite a few here calling for those Apllix guys to go should recall that the end game was not too bad... they got some 340 m for the co .. or 5x sales I recall. True, sales could have gone better - but the end game would be the same. The TM OLPA still exists... in IBM.True again, that these guys have already made their lifetime money and more... so they are in no hurry. Competion-wise there are some similarities here, too...
Market cap might make 1B again after earings (full dil) which puts us in mid-range pharma. Looking around, neos is on sale at 1/10th of our value, by EV. Ticks all the boxes if the price is right? Stock swap merger at theseprices makesa lot of sense to me - more so than that xenoport!
At their gm level, they require only another 2 m in sales to be profitable - on a non-gaap basis. Hardly demanding, given the "fever-pitch" demand! other way to look is that just a 27% increase in demand would do it.
Looks like only the 5 does, ie 500% of the now max allowed had stat sig on all counts in pain. The rescue med use is critical measure . Co was too quick to try for a P3 trial. I better P1 might have settled on a 4mg with no substantive safety issue....
The speed here is more surprising than the personnel events. Looked like deVivo was resurecting Rita with a broader portfolio, same crew. Not so... well failed! Likely that a lot of the talk devivo had was sheer drivel. The new CEO answered the bead program had made no progress, the stuff about painless evlt likely the same. The auto fluid injector he admiited was drivel... as too the hopes for a 50% growth in thrombo. Hopefully the tip finder was for real. Hard to know about Nanoknife... maybe the best thing that never happened to deVivo?
Value destruction seems tobe a short's problem here! Although all can change quite quickly. Witness Carbylan which had a Cingal copy in the works, but no longer. Still, we are now only backto the Monovisc approval pps. Cingal would add likely add 10-20.
More red flags than in Peking. Nice going concern in there too. Apart form the hope springs eternal, Paul almost forgot to mention the patents were upheld. Having a patient questioned and found valid is a lot more valuable than just getting one. Still, along way from here to there.... which is 3yrs. On the bright side the disc. busineess has an A/R of nearly 10 million attatched as well as the IP on genes and tests that was written off. In bits orpieces it should be quite valuable, though obviously wasn't interesting enough as an active business.
Shoul be cancelled ... not if awarded though. Looks like market expecting weak report th, although you'd think they set this up before they knew the q sales?
So just how many CEOs has this business chewed through! Hopefully the new guy will not spend his time explaining broken promisies like Joe did. Co. has lots of great idea-level products, but not able to execute.. and make 10 m products into 100 m products.....