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Natus Medical Inc. Message Board

culleraa 64 posts  |  Last Activity: Sep 19, 2014 3:55 PM Member since: Apr 27, 2005
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  • Reply to

    Should one be long the HA+ business?

    by culleraa Sep 17, 2014 2:21 PM
    culleraa culleraa Sep 19, 2014 3:55 PM Flag

    Not read that there is push back on HA in the US. There is in the UK for example. HA offers a 30-40% responer rate - higher than saline but only just with 95% confidence. When you know that the pain is due to your bones rubbing themselves together and wearing out even more: well, if you can get HA under insurance or a small co-pay is a no-brainer, so to speak! When you consider that the cause of OA is agexweight mostly, then there is no need to doubt the market growth. And since knee pain leads to less exercise... nuf said!
    I don't think anika investors see flexion either way yet... too many other things could happen. Take a look at that stuff which had a "fridge malfunction" in the trial ... Adam Feurstein had a good laugh at that...

  • These guys were at the Craig Hallum alpha conference on the 18th. Not much of a word to investors!!! and no webcast of course.
    Craig Hallum have kept their 9 dollar target though... which was prior to all this Ferguson stuff....

  • culleraa by culleraa Sep 19, 2014 2:49 PM Flag

    As a public company with a lot to explain to its investors, there was no reason NOT to webcast the presentation! Or was there...

  • culleraa culleraa Sep 18, 2014 12:58 PM Flag

    As I have posted before, this co. is a relatively large license stream at zero cost and a loss-making business on top. The steady royalty stream of 12m or so a year is worth 19 usd /share on an 8x"ebitda-ignorigneverythingelse" basis. This is no scam, the econolite customer relationship has been around for a decade or more and the agreement extends to 2031!
    If they get their own business on track to breakeven - said to need another 1m usd/ quarter in sales - then this sp trend would be a different story....

  • So, HA injection in the knee for OA is "not much" better than saline and is not cheap. Most trials are borderline significant... monovisc seemingly only crossed the line because orthovisc had succeeded earlier. But cross it did. Often you hear that the placebo worked better than expected!
    Efficacy of different approved products is probably the same... the differentiating factor being the AEs. But that, too, is still a technicality, the real difference is likely mostly the salesforce and their ability to pitch. Orthovisc/Monovisc has really little published data, compared to Synvisc for ex., but data is not an issue for success it appears - at least in the US. Saline might be most cost effective... it's just not approved as such and there is no financial incentive of course! Bottomline is that patients say either HA or saline injection does relieve pain for quite a long period.
    Adding a bit of steroid might be the way to go... if AEs remain low the little bit of boost might just be the additional difference needed to lower the p value beyond criticism. I have no idea of the steroid dose involved, but one can assume it is higher in Flexion's product, since it needs to be very long-lasting, unlike Cingal where the HA takes over after the steroid wears off. A Flexion approval would de-risk Cingal in the US enormously, if it gets to follow the same approval route as HAs do. Cingal could be the best of both worlds – but would attract a lot of competition if successful.
    The current 2-4000 usd/year cost of HA seems cheap for surgery-free mobility. Orthopedic surgeons certainly see it as a risk to their business! Apparently knee replacement leaves pain in 50% of cases anyway.. and who wants more than one op in a lifetime.
    At the time, Genzyme bought the Synvisc business for 10x sales when sales were 80 m or so some ten years ago. Similar metrics would put Anika at a round billion dollar btw. Synvisc used to rule the roost, pun, but no longer! Sanofi's sales are down 9% in the US H1/2014... and not grown for 3 years. Mitek is taking share as are others.

  • Reply to

    Flexion Thanks but No Thanks......

    by optiontrader99 Sep 12, 2014 4:22 PM
    culleraa culleraa Sep 17, 2014 1:26 PM Flag

    Technically, biopharma responded to you on my behalf... if you take out the "feelings"! I think it is interesting the market values the Flexion product so highly.

  • So Naloxegol gets fda's ok. Said to be a billion-class drug can you believe! Takeda might differ. This agnoist is of course only for OIC... and seems to be more effective, like twice as good as placebo in moving it... where Amitiza was like 50% ...ballpark. All that comes with pain: as many as 20% of patients had so much stomach pain to be classed as an adverse event. That's 400% of what Amitiza causes. Then there is possibility for heart attacks! Dose has to be high or it is ineffective...
    The tag line appears to be once-daily oral vs. 2xdaily oral for Amitiza.

  • culleraa culleraa Sep 12, 2014 7:41 AM Flag

    So, based on these and Tran's numbers... Sigma has 2% of the US market... room to grow!

  • A stem celll plugger, but still: ... However, Joe Namath of the NY jets became a cautionary tale of the woes of cumulative knee steroid injection side effects, as his frequent injections basically destroyed his knees.
    ...
    The new study looked at twenty patients who had either steroids or knee lubricating gel (hyaluronic acid or HA) injected into both knees and then were given a hormone stimulation test. A scary 60% of the knee steroid injection group had evidence of adrenal insufficiency versus 15% of the knee HA patients. Some patients in the steroid group still had adrenal problems two months after the injections! Adrenal insufficiency is a disease where the little glands on top of the kidneys don’t produce enough steroid hormones and can be associated with severe muscle weakness and fatigue, depression, extremely low blood pressure (hypotension), weight loss, kidney failure, and changes in mood and personality.
    The upshot? Knee steroid injection side effects and steroid injections in general are bad news. It’s unknown, given the mounting evidence of harm to patients why many physicians are still injecting steroids into the joints and spines of patients.

  • Reply to

    Flexion anyone?

    by culleraa Sep 10, 2014 2:58 PM
    culleraa culleraa Sep 12, 2014 7:29 AM Flag

    Well, not only positive of course. BUT, what has been speculated here is the lack of financial value in the added steroid... ie another cannibalizing product to orthovisc. Investor (mis?)placed interest in Flexion suggest there is value creation. A second issue is a combo product will win out against two separate shots at the same time. Cost of ingredients is a few dollars. Importantly, a lot of time and money will be wasted by being first to go up against FDA. FDA is going to look at safety more than efficacy. May be that an approved drug is better since the steroid dose should be low - very low...! More on that later

  • Looks that way. Earlier Sigma rode one STB crest in 2007, mostly missed the next gen and is now quite well placed for the coming one in 2015 or 2016. So is that 4-5 yrs. Likewise in DTV, Vizio deal was in 2012... but should still grow for several years from now.Costs too much to swap out designs completely .. so they go from level 1 to level 2. Main difference now is that there are many waves to ride! The Z-wave is maybe the exception, as it has been a steady grower except for block sales of licenses. Z-wave seems to be a 25m business right now... getting to be significant for the whole co. So, if the sales follow the cycles, and so does the stock price, then a few good years ahead! IF....

  • Reply to

    Could get interesting soon?

    by culleraa Sep 9, 2014 4:36 AM
    culleraa culleraa Sep 11, 2014 6:49 AM Flag

    Yeah, well... On the product side the explanation is largely a probably one-time shipment of the "old" sonastar to the tune of 1 million. Took care of seasonality this time! Despite that, stock could go double digits anyways....

  • culleraa by culleraa Sep 10, 2014 2:58 PM Flag

    That stock going up a lot as FDA looks favorably on their trial in OA. Some 300 market cap. Wierd thing though is that the active ingredient is basically the same as what Anika is adding to HA in Cingal. "Long-acting" steroid Now as said before the steroid so far has been useful short term ... was Flexion stuff 12 weeks? ... anyways the generic steroid is it is very cheap, 10 bucks or so, as a shot vs HA. Flexion are thinking of 800 a shot?
    Seems to me this might mean that Anika will get looked on in a similar manner when Cingal is put to the FDA... ie not multi-dose studies prior to filing - and saving time. Cingal is monovisc + the same kind of steroid. Flexion says a year is saved.
    All in all, looks like investors are giving the steroid opportunity a huge market cap vs development stage. Makes Anika look cheap!

  • Reply to

    Both sides of the story

    by culleraa Sep 9, 2014 4:20 AM
    culleraa culleraa Sep 9, 2014 8:05 AM Flag

    Agreed! Odd how the regulatory issues first hinder then help value creation....
    Considering Sirgo's comment, crtsy seekingalpha: "And I think last, certainly not the least this Clonidine Topical Gel .... so I actually think that this product has more potential than anything in our pipeline", your earlier comment on Clonidine was quite prescient!
    Seems to be quite odd that such an "old" medication can be packaged well enough to be effective. I am kind of familiar with the cortical stimulation approach to treating neuropathic pain, via compensating fro supposed missing afferent feedback, but this gel is an awful lot simpler! bdsi paid quite little for the program, and despite milestones and royalties I kind of trust Sirgo would not make that comment without thinking it through....

  • Very low float means active punters could take control here... seems to be the silly season! On a financial level, the business is basically free. The npv of the royalty stream, the cash plus what might come from Sonablate adds up the market cap. Then when you look at the valuations of eg the Israeli mdwd in debridement alone you can see someone making a case for a 20 ish stock price. Bone scalpel is the real story for a while... but q results will have summer seasonality in them.

  • Like the stock quote, it's always worth listening to both sides of an argument. Not as long as some, but as a 7-8 year investor I have been through the 2011 trial results which did not show significant pain relief for bemabup compared to placebo in a mixed pain population. By separating the populations, screening and titrating, the effect can be shown. What this tells you is that in the real world sales skills and physician education will be key... so it is good we have an experienced partner. Anecdotally, eg drugs.com, systemic Buprenorphine works, buccal should work better - but not for everyone. Withdrawal time is long...but not a commercialization issue. So, "Who..." has valid points Buprenorphine is an "old" drug. The Bema technology can, however, make this safety-proven old drug have a more effective profile and now the playing field will get a whole lot wider.

  • culleraa culleraa Sep 4, 2014 6:01 AM Flag

    So what's the model?! I figured between 9 and 19 is realistic in "near-term". Isns is a royalty stream with a loss-making business attached, which gives the 19 - if buyer ditches the loss making bit. Royalty streams do not go on forever, although this one has been very long and not obviously just patent -dependent, so that is to be considered...

  • Got Langer to chair the BOD.... quite a crew, so maybe it was an op not to be missed....

  • Opens a few gates for icad, too. Wonder if yesterday's bump was due to that news being discovered. GE makes news on 2, but letter was Aug 26th from FDA.

  • Reply to

    ISNS back to the glory days?

    by culleraa Aug 27, 2014 7:46 AM
    culleraa culleraa Sep 3, 2014 8:04 AM Flag

    Well. might be the andywarhol kind of glory.. but stock might see that "normal" price might be seen sooner than thought. More to do with low float and other playing with winnings.
    On the other hand, the steady royalty stream of 12m or so a year is worth 19/share on an 8x"ebitda-ignorigneverythingelse" basis - so on fundamentals there is the argument that private equity would see this a dirt cheap flip at 6-7....

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