I believe Osiris has already applied for reimbursement status from all 8 of the Medicare Administrative Contractors (MAC) jurisdictions. There are actually 10 jurisdictions, but two of the Contractors handle two each of the jurisdictions, therefore there are only 8 MACs. Each jurisdiction handles a certain block of adjacent states so that all 50 states are covered.
The key elements needed to push a product through the Medicare hoops to get reimbursement approval are; 1) An FDA sanctioned product, 2) a product that is efficaious in its purpose, 3) manufactured in an FDA approved facility, 4) proof of efficacy demostrated by scientific trials, 5) peer reviews, white papers and publication in an accepted scientific journal.
Osiris' last hurdle is the publication in a scientific journal and I believe that will happen in April 2014 issue or no later than the May issue. But, the publication timing is not up to Osiris, the journal makes that decision.
As I understand it, Osiris has "pass through" reimbursement price control exemption for 2014 and they are eligible for "pass through" status through the first half of 2015, however 2015 is not guaranteed yet because these type of decisions are made one year at a time by Medicare,
Osiris is getting ready for tighter price controls at sometime in the future; by developing some smaller Grafix sizes and releasing them sometime in this second quarter 2014. Make no mistake about it, Osiris will compete.
Yes, I should adjust the PPS estimate according to any new product pricing, but I don't know enough about those changes to do that right now.
"COLUMBIA, Md.--(BUSINESS WIRE)-- Osiris Therapeutics, Inc. (NASDAQ:OSIR), the leading stem cell company focused on developing and marketing products to treat conditions in wound care, orthopedic and sports medicine markets announced today that Lode Debrabandere, Ph.D., President and Chief Executive Officer, is scheduled to present at the 2014 Canaccord Genuity Musculoskeletal Conference on Tuesday, March 11, 2014 at 2:20 p.m. ET (1:20 a.m. CT) in New Orleans."
"A live webcast of the presentation may be accessed..."
Osiris is on the move!
I agreed pretty much with everything you said except your supposition about Dr. Mills. That comment is completely wrong and totally unfounded. Dr. Mills was and still is, highly respected by Osiris principles and his resignation was what he said it was...nothing else! Please don;t disparage his reputation like that.
It's very obvious that there is a coordinated group working to derail Osiris' movement into the Wound Care market. It is only normal business practice for the competition to fight back and throw up all the road blocks they can muster. No one has said it would be easy carving out your own market space in this tough business.
But, here is something to keep in mind:
"Revenue Increased 3-Fold, Company was Profitable and Ended with Assets of $92.0 Million". Osiris did this with around 10 full time Sales professionals and now Osiris has 58 full time Sales people...all marching towards a great 1st quarter 2014. Dr. Debrabandere even commented in the conference call that Inventory is currently less than a 30 day supply. In my opinion, this was a hint that the new sales force was ripping through the inventory and Sales are booming.
I'm not going to let a gang of so-called analyst, spewing a story of half truths, convince me that there are future dire consequences. A few minutes of Due Diligence makes their story fall completely apart.
Also note that MiMedx is still running with negative Earnings which is in stark contrast to Osiris' positive Earnings and without being dilutive to the shareholders. Osiris is taking the "high road" and providing believable and high quality trials and MeMedx trials...well, not so much.. .theirs are pretty mush a joke.
That prospective depends upon your entry point, many of us have some shares starting around the $4.50 mark. All of my shares are "in-the-money" and many of the other Longs here have a similar experience. Real Longs don't bail following market cycles, they wait for long term growth over time...5 years or longer.
Osiris is the leading company with a wound care product containing live "Stem Cells", i. e. Mesemchymal Stem Cells, whereby Epifix doesn't contain any live MSCs.
Osiris' revenue was produced with just 10 full time salespeople, how many salespeople did Epifix have during this same period...well over 100?
Mimedx had a negative 4 cents lost per share and Osiris has a positive 11 cents per chare earnings from continining operations plus another $1.36 per share earnings for their sale of Prochymal...that's a total of $1.47 per share of postive earnings. I think you can quit wondering where Osiris is going to get money for future expansion and perhap start wondering when Mimedx might start earning a profit.
The low hanging Stops have now been scraped and collected from the short term traders and positive earnings should be ready to be reported at tomorrows conference. You may just get your wish!
"Osiris Therapeutics, Inc. (NASDAQ: OSIR), announced today that a scientific study evaluating the key attributes of Cartiform® will be presented at the 2014 American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting, March 11-15, in New Orleans, Louisiana. C. Thomas Vangsness, Jr., MD, Professor of Orthopedic Surgery at USC's Keck School of Medicine and Chief of Sports Medicine at University Hospital will present the findings of the study."
Exactly, that is it!
Mimedx just hired another round of Sales people and then bragged about another successful Epifix trial, but offered little trial details to substantiate their claims.
I found the transcript of the Mimedx conference call very difficult to decipher and to pull out any intended message. It seemed like the primary speaker had difficulty in forming a coherent sentence. I suspect that some sort of Jack Daniel type of beverage was somehow involved.
It's no big secret...Osiris management has already announced that upon the successful transfer of the sold Prochymall assets to Mesoblast, Osiris will post positive earnings from the proceeds of the Sale. They've commented that the proceeds received will be large enough to erase all of the negative earnings for the entire 2013 year. Since that proclamation, Osiris did successfully transfer those assets and they have collected the proceeds of the Sale.
Total balance between buyers and Sellers was achieved today; with neither side moving off their positions. Whenever the Shorts sold an Osiris Long was standing ready to buy up their shares. The net result was probably more Shorts praying for a bad 4th quarter. But, the Longs have been paying attention and know that the 4th quarter will be very profitable due to the Prochymal sale to Mesoblast.
The Shorts and naysayers have been playing the Ostrich game, by hiding their heads in the sand and refusing to believe that Osiris will move into positive territory.
The Longs have listened closely to Osiris management and have seen evidence of many new Sales professionals signing on with Osiris. We've also seen many Institutions and Funds taking up new positions in Osiris shares, which can easily be verified by looking at their year end reporting..
There are 4 more trading days left before Osiris gives us their 4th quarter report, next Wednesday. Bad news is generally given out on a Friday, therefore a Wednesday reporting date bodes well for the Osiris Longs. All of our arrows are now pointing UP.
We'd like to see you come back in with yours guns blazing away at the bid. Either way, the Shorts are going to be in soooo much trouble!
Agreed, breakout pressure is building. In my opiniion, we're over $20 in a little over a week. Things are happening on the Sales front.
Can't wait to read what the Cramer/Feuerstein and their trained lackeys will be saying this quarter. I'm sure they've got their coordinated theme already written and are just waiting for the actual 4th qtr report to hit. Everyone here will be doing belly laughs at their convoluted logic, which they will probably try to use to explain why Osiris is dead. I'm sure they will all be singing their qued up song; "It's a one time event".
Osiris has full time sales people in the areas shown below. I found these in just a few minutes of searching, but there are probably a lot others that I didn't find. Yes, I've got the names of the Sales professionals associated with these territories.
Baltimore, Maryland Area
Sacramento, California Area
Washington D.C. Metro Area
Rockville Centre, New York Greater New York City Area
Greater Denver Colorado Area
Orange County, California Area
Greater Minneapolis-St. Paul Area
Hellertown, Pennsylvania (Allentown, Pennsylvania Area)
Cockeysville, Maryland, Baltimore. Maryland
Cedar Rapids, Michigan
Indianapolis, Indiana Area
Kansas City, Missouri Area
Osiris also has these large Distributors and there are probably others that I didn’t find:
Alano Medical Devices
Osiris is building up their Sales force and last quarter committed to adding 50 more Sales people. Perhaps we will get an update and current status during the March 5th conference call?
Osiris is spreading out all across the country.
Osiris is probably getting pretty close to 50 Grafix Sales people and I'd expect an addition of another 50 by the end of 2014. The 100 Grafix Salesforce is very likely to happen this year.
However, I don't think they are ready to bump up the Sales force for OvationOS and Cartiform. They would probalby want to publish some trial data first. But, I'd love to see that 100 OvationOS/Cartiform Salesforce.
Osiris is growing by leaps and bounds!
Nice find babykahn!
And...Osiris is getting quality people too, ready to hit the ground running after onlly a couple of weeks training.
Osiris just hands them an order book, assigns a territory and turns them loose!
This is just background noise. The true longs are holding onto their shares with an alligator vise grip. The Longs know the score. I'd like to see the Short count move up to around 5 million before Osiris' 1st quarter results coming in May, However, the 4th qtr 2013 resutls will probably scare most of the Shorts away, therefore I doubt that they will have the nerve to double down for the 1st qtr 2014.
The party is about to begin!
Retail investors were trying hard to get-in under $17, but just the slightest amount of buying pressure moves the share price. If you've done your due diligence, you should now realize that this stock is headed for over $20 and long term to triple digits. Therefore, quibbling over pennies at this level will soon seem very foolish.
If you can capture a few shares under $20, count yourself very lucky.
4th Quarter 2013 Earnings Estimates: 1.290 | 0.645 | 0.000 (High | Mean | Low)
Osiris should be turning the corner and moving into positive earnings. This is the point in time where Osiris can really start growing by reinvesting the extra cash into a larger Sales force, develop sales campaigns with slick promotional advertising, upgrade the website and streamline the manufacturing process.
Although this 4th quarter report will not likely show huge Sales numbers (in my opinion), it be enough to likely start the engines and kick the share price into high gear for the balance of 2014. Each successive quarter should begin to set new Sales records.
And...the share price goes up when real shares are actually bought. Shorts can trade the same100 shares back and forth all day long, but the overall share price trend is...up.
Osiris Sales force is up, Sales are up, Cash is up, Non-cash assets are up, Employment is up, number of new products are up and the share price is up.
Look for the key word here...the trend is UP.