250 m in synergies need to be found to pay for it.... which is actually not that much %-wise. That said cfn was already plucked clean for the sale! OMcl should benefit for several years from the disruption, although golden retainers will mean incentives to sell Pyxis this q4 will be high. Long term, where does omcl want to be in this megamergermania?
You are right that HA is more an established market... that means hype will not carry far. It odes mean though that there is a lot of money that can be directed to a better mousetrap if someone comes up with one!
Anika is growing ex-US ortho business... 2013 US buisness was up some 13% (factor out milestone and optho-delta), same time ex-US was up 9-10% with declining dollar - not much to choose. Critic should be why is Anika not growing other businesses in the USA!
I think GelSyn proves the point.. no-one will distribute. An Oslo co. boxed an attempt to put a German product in the US this year for that reason. The pathway to the market got easier, but only in principle, it is now non-inferiority to something approved - a typical 510k ploy.
Q-med went for the beauty market and did well, Anika went for the ortho market - not sooo well yet, but market is bigger and more profitable...maybe for the latter
Well, VIX... where we were a week ago.Still, now we have news. He will go at 65, so a normal retirement age. He has been good for Staar but I am sure someone will link the fda letter/TICL delay to this...but all noise in the end. You would normally choose to bow out at the peak not a trough...if you can. Just maybe Board is not allowing him to wait?
Long process... board will likely wait 6-9m to announce next CEO.More VIX in the meantime!
In the event the Company does not meet its financial covenants after October 1, 2014 and SVB does not extend a waiver or forbearance agreement, and the Company believes that it does not have adequate liquidity to operate, it will implement a cost cutting plan that reduces its expenditures to the appropriate level to be in line with its operating cash flows.... don't look good...
Some look at just the financials, but I look at the business:
The HA business is huge: all told, multi-billion blockbuster drug size
Pipeline within a pipeline: high/low MW, cross-linked or not, as a natural fluid can be easily combined or used as substrate
Growing demand, repeat business
Human HA is a natural product, pure HA has little risk and an easy FDA pathway on safety
RandD investments are low, although manufacturing relatively high investment for non-avian stuff
Not a generics business, all branded
Depending on the geography/application, can be very profitable, biotech like profit margins
Anika is the only way for an investor to get direct exposure to the HA business
Anika has best distributor in the business
Acquirer willing to pay high multiple for a solid brand: eg Q-med was bought for some 1.2 billion usd by Galderma, or nearly 10xsales
Someone else can add the negatives!
Hard to figure the stock price swings lately. Filed data show the aq was rather good. Too good to be true actually. 2013 the move would not have made financial sense... so one wonders how hard they (Erb) worked the numbers in Q2 to get bought out! Loss turns to gain at the pre-tax level... although the accountants missed that in the text column!
Can't find the Bloomberg article but Dr. Leen is doing a trial of IRE in the UK. That headline is from the Mail paper.
Op said to cost "just" 10k.. or 16,000 usd. Sutent costs are double that for a year!
Note the following: By perforating the cells, it also potentially allows chemotherapy — generally administered after the operation — to work more effectively on the cancer cells. ie pay the 16k for the op to make the sutent worthwhile....
Well, I would wait as long as possible. Knee replacement is more difficult with worse outcomes than hip - which surprises many. Few are able to kneel ever again, many have pain, was it 20% or so clinical pain, and quite a few more pain than before op! That said, bigger problem is increasing demand... said to grow by 600% by 2030.
In that light, using HA for the hip ( Synvisc is in trial for this again) is a smaller market, smaller problem and more difficult to inject.
There is a recent claims study, huge - 17 000 patients, showing HA is hugely effective in delaying knee replacement. One reason surgeons being so aggressively against HA? surely not!
This was a JJ supported study.... suggesting each shot/s delays surgery by 7 months.
from ACS site:....observed Dr. Altman, professor emeritus of medicine at the University of California, Los Angeles. ... the study demonstrated a strong dose-dependent relationship between viscosupplementation and time from first specialist visit to knee replacement surgery, he noted.
Seventy-nine percent of patients who got hyaluronic acid injections received a single course consisting of either one injection or a series of injections, depending upon the specific product. Those patients experienced a median 233-day increase in the time to surgery, compared with matched controls who didn’t get hyaluronic acid injections.
Moreover, the 16% of viscosupplementation recipients who underwent a second round of treatment further delayed their median time from first specialist visit to total knee replacement by an additional 7 months. And that pattern continued in the relatively small numbers of patients who underwent three or more courses of viscosupplementation: Each round of hyaluronic acid injections brought a roughly 7-month further delay in time to surgery, out to a total of 2.6 years.
This Levi is spreading his clap around... no idea what it is but deVivo here had a good year in 2014: compensation up 270%. Shareholders saw the share price... will do nothing. Something of a mismatch here? Now we should vote for more dilution....?
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....
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.
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.
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.