Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Update on Augment:
Robert J. Palmisano - Chief Executive Officer, President and Director
I would like to provide a brief update on the status of our appeal for Augment Bone Graft. As previously disclosed, we submitted an amendment to our premarket application on April 29 of this year. We continue to work interactively with the FDA to answer their questions and still expect the Office of Device Evaluation to issue an approvability determination no later than October 26, 2014. Although we view the amendment process and the interactions with the FDA as constructive, it is important to reiterate there is no guarantee this PMA Amendment will result in approval for Augment Bone Graft. We will continue to keep you informed through our normal communication channels.
We are looking forward to the resolution of the Augment PMA Amendment by the end of October. While we have no way of knowing the final determination with the FDA, we believe that the PMA Amendment that we submitted has excellent science behind it and meets the FDA's needs for approvability for this breakthrough biologic.
Additionally, we continue to make good progress on our Vital Few initiatives and the Augment PMA Amendment process.
Matthew O'Brien - William Blair & Company L.L.C., Research Division
Okay. And then just -- that's very helpful. One more for me. I know you don't want to speculate on -- on Augment approval, but given that your sales force has been coming through getting trained on other products and INFINITY and so on, have you been engaging in any kind the activities right now, in preparation for a potential Augment approval? [indiscernible] start selling kind of next day if you were to get that approval at the end of October?
Robert J. Palmisano - Chief Executive Officer, President and Director
No. We haven't. I'll tell you why. Is that my expense with these PMAs, and this may be a big exception, but my experience with these PMAs is that even if we're fortunate enough to get an approvable letter, there's still things to work out with the agency that's going to take several months. They're always looking for a post-market study, a post-approval study. There may be some labeling discussions. So if we're -- if we do get this approvable status as of the end of October, it's going to be several months actually, I think, before we're in the market and that will give us time to really gear up.
Now we hope that Augment will work out, but that has been kind of a struggle for us and for me to get my mind around. I still think that given the information we had, it was a good decision and hopefully, it'll turn out well.
Joanne K. Wuensch - BMO Capital Markets U.S.
Briefly, you started off by talking about the FDA process for Augment. Have you been having any back-and-forth conversation with the FDA?
Robert J. Palmisano - Chief Executive Officer, President and Director
Yes. We have a dialogue that is quite robust, is the way I would put it. There's a lot of back-and-forth with them. If I were to look at it, there's two things. There's form and substance. Substantively, there's no change. We don't know how this is all going to turn out. But the form of it, the process is, it seems good to me in terms of we're able to get our questions answered, we have very clear lines of communication, there's a lot of communication. And I think so from a process point of view, it's good. But given that, I don't know, again, what the final result will say. But there is a lot of communication between us and them.
Joanne K. Wuensch - BMO Capital Markets U.S.
At 1 stage you were talking about a $300 million market opportunity. Do you still think it's that large? And how long do you think it takes for you to tap that?
Robert J. Palmisano - Chief Executive Officer, President and Director
Yes, we do. We do think it's that large. And I suspect that that's the total market. I don't know if you're ever going to tap all of it. But I think that -- I don't know what time period but maybe within 5 years or so, it might be a good time now to get that full amount. If things always do start out and take time to build. But I do think that the market, based upon the number of cases and the ASPs that we're thinking of, get you to that number pretty comfortably.
Source: http://seekingalpha.com/article/2385855-wright-medical-groups-wmgi-ceo-robert-palmisano-on-q2-2014-results-earnings-call-transcript
“We submitted our Augment PMA amendment on April 29, 2014. Although it took us a few weeks longer to file
the amendment than we originally anticipated, we believe the extra time allowed us to work collaboratively with the FDA to gain a more
precise understanding of their expectations for the content of the amendment. As previously communicated, we expect the Office of
Device Evaluation to issue a determination on whether the PMA is approvable no later than 180 days after this submission date.”
Source: http://www.sec.gov/Archives/edgar/data/1137861/000113786114000026/wmgi3312014exhibit991press.htm
On March 10, 2014, we reached an agreement with the Office of Device Evaluation (ODE) of the U.S. Food and Drug Administration (FDA) under which ODE will accept a further amendment to the Pre-Market Approval application (PMA) for Augment® Bone Graft in lieu of proceeding with the Dispute Resolution Panel (DRP) that was scheduled for the week of May 19, 2014. The PMA amendment will consist of analyses of pre-existing radiographic films of clinical study patients at pre-operative and post-operative time points. ODE has committed to an expeditious review of the PMA amendment and agreed to issue a determination on whether the PMA is approvable no later than 180 days after submission of the PMA amendment. We note that this PMA amendment does not guarantee the approval of Augment® Bone Graft, and that we intend to renew the DRP process if the PMA amendment fails to result in a reversal of ODE’s previous not approvable determination.
Our international sales increased 63% to $22.1 million in the first quarter of 2014, compared to $13.5 million in the first quarter of 2013, primarily due to the Biotech acquisition in the fourth quarter of 2013. Acquired products from Biotech contributed 34 percentage points of the international growth. The remaining growth was driven primarily by a 17% increase in Europe, a 55% increase in Asia as the result of the addition of a new distribution partner in China during the quarter ended June 30, 2013, and a 27% increase in Australia due to increased sales of Augment® Bone Graft acquired in the first quarter of 2013.
Our international biologics sales increased 40% as the result of a 47% increase of sales in Australia, primarily related to sales of Augment® Bone Graft acquired from the BioMimetic acquisition in the first quarter of 2013, and a 55% increase in Asia as the result of the addition of a new distribution partner in China in the second quarter of 2013.
On March 10, 2014, we reached an agreement with the Office of Device Evaluation (ODE) of the U.S. Food and Drug Administration (FDA) under which ODE will accept a further amendment to the Pre-Market Approval application (PMA) for Augment® Bone Graft in lieu of proceeding with the Dispute Resolution Panel (DRP) that was scheduled for the week of May 19, 2014. The PMA amendment will consist of analyses of pre-existing radiographic films of clinical study patients at pre-operative and post-operative time points. ODE has committed to an expeditious review of the PMA amendment and agreed to issue a determination on whether the PMA is approvable no later than 180 days after submission of the PMA amendment. We note that this PMA amendment does not guarantee the approval of Augment® Bone Graft, and that we intend to renew the DRP process if the PMA amendment fails to result in a reversal of ODE’s previous not approvable determination.
The IPRD projects acquired are as follows:
•
Augment® Bone Graft (Augment) is based on our platform regenerative technology, which combines an engineered version of recombinant human platelet-derived growth factor BB (rhPDGF-BB), one of the principal wound healing and tissue repair stimulators in the body, with tissue specific matrices, when appropriate. This product is intended to offer physicians advanced biological solutions to actively stimulate the body’s natural tissue regenerative process. Augment is targeted to be used in the open (surgical) treatment of fusions. Additionally, Augment may be useful in the future to be used in open fractures. We have evaluated Augment in several open clinical applications, including foot and ankle fusions and distal radius fractures. We believe we have demonstrated that our technology is safe and effective in stimulating bone regeneration with the Canadian regulatory approval of Augment in 2009 and the Australian and New Zealand regulatory clearance of Augment in 2011. A PMA application for the use of Augment in the U.S. as an alternative to autograft in hindfoot and ankle fusion procedures was submitted to the FDA prior to this acquisition. We’ve incurred expenses of approximately $8.2 million for Augment since the date of acquisition and approximately $2.8 million in the three months ended March 31, 2014. Future costs related to Augment depends on the ultimate decision by the FDA on the PMA.
•
Augment® Injectable Bone Graft (Augment Injectable) combines rhPDGF-BB with an injectable bone matrix, and is targeted to be used in either open (surgical) treatment of fusions and fractures or closed (non-surgical) or minimally invasive treatment of fractures. Augment Injectable can be injected into a fusion or fracture site during an open surgical procedure, or it can be injected through the skin into a fracture site, in either case locally delivering rhPDGF-BB to promote fusion or fracture repair. Our initial clinical development program for Augment Injectable has focused on securing regulatory approval for open indications in the United States and in several markets outside the U.S. Recently, we have focused our efforts on securing FDA approval of Augment. The amount of time and cost to complete the Augment Injectable project depends upon the nature of the approval we ultimately receive for Augment, but we currently estimate it could take one to three years. We’ve incurred expenses of approximately $1.9 million for Augment Injectable since the date of acquisition and approximately $0.1 million in the three months ended March 31, 2014. Future costs related to Augment depends on the ultimate decision by the FDA on the PMA.
Source: http://www.sec.gov/Archives/edgar/data/1137861/000113786114000029/wmgi331201410q.htm
Latest Update on Augment:
I would like to give a brief update on the status of our appeal for Augment Bone Graft. We submitted the agreed upon amendment to our PreMarket Approval application for Augment Bone Graft yesterday. Although it took us a few weeks longer to file the amendment than we originally anticipated, we believe the extra time allowed us to work collaboratively with the FDA and to gain a more precise understanding of their expectations for the content of this amendment.
As previously communicated, we expect the Office of Device Evaluation to issue a determination on whether the PMA is approvable no later than 180 days after the submission date. It is important to reiterate that there is no guarantee this PMA amendment will result in an approval of Augment Bone Graft. We will continue to keep you informed through normal communication channels.
We are looking forward to the resolution of the Augment PMA amendment. While we have no way of knowing the final determination of the FDA, we believe the PMA amendment that we submitted this week has excellent science behind it and supports the safety and efficacy of this breakthrough biologic.
Our global Biologics business grew 16% on a constant currency basis in the first quarter due to growth in our International Biologics business driven by sales in China as we open sales channels and continue the growth of Augment Bone Graft in Australia.
Christopher T. Pasquale - JP Morgan Chase & Co, Research Division
Okay, fair enough. And then on Augment and the PMA Supplement, I'm just wondering if there is -- are any other milestones or communications we should expect between now and the end of that 180-day window or will the decision on approvability be the first we hear? And could that clock stop if the agency comes back with a round of questions and there's some back-and-forth or is that 180 days all-inclusive?
Robert J. Palmisano - Chief Executive Officer, President and Director
Yes, I think the 180 days is the time frame to look at. We do have a -- we have ongoing communications with the agency. We have a face-to-face meeting with them scheduled for 45 days from yesterday to make sure that everything is on track. But I don't think any news will come out of that because they're not going to cite any -- we're just going to be -- it's more inside base book kinds of stuff that go on at those kinds of meetings. So I think that the news will be in 180 days. I have -- again, I've said this often, I've no way of handicapping what the agency may or may not do, feel very good about the science behind our submission. I feel good that the extra time that we took, working collaboratively with the FDA to really in a much more precise manner understand what they're looking for and what it would take to be approvable is all beneficial. Having said that, again, I have to give the caveat I have no idea how this is going to turn out.
Raj Denhoy - Jefferies LLC, Research Division
Bob, just quickly on Augment. I think you made -- most of your public commentary has been pretty cautious. I think you've mentioned that you're still pretty far apart from the agency on the product and its approval. But you've also made some comments around the margin about how you've been encouraged by their willingness to sort of reconsider the framework under which they're looking at the product and what the really the questions are that the product is trying to address. And so I guess, I'm curious if you have any broader thoughts on where this sits at this point? I mean, is there reason to be optimistic at this point? Or are you truly still very far apart on this?
Robert J. Palmisano - Chief Executive Officer, President and Director
Well, I think that, as I said earlier, I'm not really in a position or -- nor do I want to handicap what the agency might do. It's a peculiar environment that they're in. What was -- what's interesting is don't forget is that the agency came to us and suggested that instead of a Dispute Resolution Panel, which is an adversarial, time-consuming process, is that they would be willing to entertain an amendment. And that was at their initiative. Then we spent a lot of time interacting with the agency to decide or to frame what exactly that amendment would look like and what it would take for the agency to -- what type of data the agency -- data and science the agency is looking for, for us to be successful with this. And what we were able to gain through that process was really a much more precise understanding and an agreement with them as to what it's going to take. So for that point of view, we feel good and we feel good about the science in our amendment. However, is that -- and then the other part of that is that I don't think that -- when we got this non-approval letter, I got on the phone to talk about this and said I was shocked about it because what the questions that they raised in the non-approvable letter really caught us by surprise in that they weren't really part of the study that we actually did. I think we now we have a really good understanding and they -- between them and us, and us and them as to what that data needs to look like and what they are looking for. So we're -- so from that point of view, I would say that I think that's all good is that we have an understanding, we provided them with data, we provided them with science, we think that the data and the science supports the safety and efficacy of the product. Now it's in their hands and they will deal with it and we will interact with them. But I feel good about not being in the DRP, I feel good about being in the amendment process, and I feel good about the cooperation that we've had with the agency to get to this point.
Raj Denhoy - Jefferies LLC, Research Division
Okay. So would it be fair to characterize it as you've sort of come to an agreement in a sense on what you need to give them and you believe that what you're giving them satisfies it, but of course, there are still the vagaries of what the agency is going to do?
Robert J. Palmisano - Chief Executive Officer, President and Director
Yes, I would say that, absolutely yes, that's my point of view.
Matthew O'Brien - William Blair & Company L.L.C., Research Division
Just a follow-up on the last points you were making there, Bob. The delay that we saw in the filing of the PMA Supplement with the agency, was that more a function of them saying to you, a little more data here is what we need, a couple more film, a bit more film? Or was it just an administrative change that they were asking for specifically that caused the slight delay?
Robert J. Palmisano - Chief Executive Officer, President and Director
When we agreed to the amendment, there were a couple of items that were "to be negotiated." And that's what we -- and that did take a couple of weeks longer than we thought and that had to do really in kind of 3 areas, Matt. It had to do in terms of an analysis of the existing radiographic films that would demonstrate that the product -- that bone grew through the graft and we were able to provide that. Secondly, it had to do with making sure that we had a statistical validation of the methods so that when the data went in is that we had outside people or statisticians validate the process. And thirdly was the addition of a second reader of the radiographic film. So all 3 of those things took those extra couple of weeks. But all 3 of those things, I think, in my humble opinion and I'm not a doctor or an FDA person, strengthened the submission.
Matthew O'Brien - William Blair & Company L.L.C., Research Division
Okay. So that was them coming back to you specifically and saying, if you do something along these lines, that's what we'd like to see?
Robert J. Palmisano - Chief Executive Officer, President and Director
Yes, generally, that's right.
Source: http://seekingalpha.com/article/2179493-wright-medical-group-management-discusses-q1-2014-results-earnings-call-transcript
Buying WMGIZ hand and fist. WMGI has great expectations for Augment, also they said that Augment is doing well overseas, meaning the Revenue Milestones of $3.00 will likely be met, all imo.
Latest update on Augment:
http://phx.corporate-ir.net/phoenix.zhtml?p=irol-eventDetails&c=129751&eventID=5087617
WMGIZ revenue milestones will likely be met regardless of FDA approval, as Biomimetic has other products and Augment is sold overseas, imo. WMGIZ will likely go back to the $3.00 range it was in before FDA Augment PMA denial this past august, all imo.
WMGIZ
Wright Medical Group, Inc. Announces Agreement with FDA Office of Device Evaluation to File PMA Amendment for Augment(R) Bone Graft In Lieu of Dispute Resolution Panel
EmailPrinter
Friendlysmaller Text larger
FDA Determination on Whether PMA is Approvable Expected in 3Q, 2014
MEMPHIS, Tenn.--(BUSINESS WIRE)--March 10, 2014--
Wright Medical Group, Inc. (NASDAQ: WMGI) today announced it has reached an agreement with the Office of Device Evaluation (ODE) of the U.S. Food and Drug Administration (FDA) under which ODE will accept a further amendment to the Pre-Market Approval application (PMA) for Augment(R) Bone Graft in lieu of proceeding with the Dispute Resolution Panel (DRP) that was scheduled for the week of May 19, 2014. The agreement with ODE remains subject to final approval by the FDA appeal authority. That approval is expected shortly.
The PMA amendment, which the company expects to submit on or about March 31, 2014, will consist of analyses of pre-existing radiographic films of clinical study patients at pre-operative and post-operative time points. ODE has committed to an expeditious review of the PMA amendment and agreed to issue a determination on whether the PMA is approvable no later than 180 days after submission of the PMA amendment. The company intends to renew the DRP process if the PMA amendment fails to result in a reversal of ODE's previous not approvability determination.
Commenting on this development, Robert Palmisano, president and chief executive officer, stated, "Since inception of the DRP process, Wright and ODE were encouraged by the FDA Ombudsman to continue discussing alternative ways to resolve the dispute. These discussions proceeded slowly but gathered steam in recent days as the timeline for DRP submissions grew nearer. The result is something we consider to be a good mechanism for moving forward."
Palmisano continued, "While this development is cause for somewhat greater optimism than we have thus far had reason to embrace, it is important to reiterate that the parties' positions are still far apart and there is no guarantee this PMA amendment will result in an approval for Augment Bone Graft. Nevertheless, we are pleased we were able to work collaboratively with FDA to identify a path forward that does not require new clinical studies to get to the next approvability determination."
Source: http://online.wsj.com/article/PR-CO-20140310-909836.html
WMGIZ was over $3.00 before FDA denied the PMA for Augment last August. WMGIZ might go well over that, imo.
WMGIZ
Wright Medical Group, Inc. (Nasdaq: WMGI) announced it has reached an agreement with the Office of Device Evaluation (ODE) of the U.S. Food and Drug Administration (FDA) under which ODE will accept a further amendment to the Pre-Market Approval application (PMA) for Augment Bone Graft in lieu of proceeding with the Dispute Resolution Panel (DRP) that was scheduled for the week of May 19, 2014. The agreement with ODE remains subject to final approval by the FDA appeal authority. That approval is expected shortly.
The PMA amendment, which the company expects to submit on or about March 31, 2014, will consist of analyses of pre-existing radiographic films of clinical study patients at pre-operative and post-operative time points. ODE has committed to an expeditious review of the PMA amendment and agreed to issue a determination on whether the PMA is approvable no later than 180 days after submission of the PMA amendment. The company intends to renew the DRP process if the PMA amendment fails to result in a reversal of ODE’s previous not approvability determination.
Commenting on this development, Robert Palmisano, president and chief executive officer, stated, “Since inception of the DRP process, Wright and ODE were encouraged by the FDA Ombudsman to continue discussing alternative ways to resolve the dispute. These discussions proceeded slowly but gathered steam in recent days as the timeline for DRP submissions grew nearer. The result is something we consider to be a good mechanism for moving forward.”
Palmisano continued, “While this development is cause for somewhat greater optimism than we have thus far had reason to embrace, it is important to reiterate that the parties’ positions are still far apart and there is no guarantee this PMA amendment will result in an approval for Augment Bone Graft. Nevertheless, we are pleased we were able to work collaboratively with FDA to identify a path forward that does not require new clinical studies to get to the next approvability determination.”
Source: http://www.streetinsider.com/Corporate+News/Wright+Medical+Group+(WMGI),+FDA+ODE+Enter+Agreement+for+Augment+Bone+Graft/9266188.html
Wright Medical Group, Inc. Announces Agreement with FDA Office of Device Evaluation to File PMA Amendment for Augment® Bone Graft In Lieu of Dispute Resolution Panel
FDA Determination on Whether PMA is Approvable Expected in 3Q, 2014
MEMPHIS, Tenn.--(BUSINESS WIRE)--Mar. 10, 2014-- Wright Medical Group, Inc. (NASDAQ: WMGI) today announced it has reached an agreement with the Office of Device Evaluation (ODE) of the U.S. Food and Drug Administration (FDA) under which ODE will accept a further amendment to the Pre-Market Approval application (PMA) for Augment® Bone Graft in lieu of proceeding with the Dispute Resolution Panel (DRP) that was scheduled for the week of May 19, 2014. The agreement with ODE remains subject to final approval by the FDA appeal authority. That approval is expected shortly.
The PMA amendment, which the company expects to submit on or about March 31, 2014, will consist of analyses of pre-existing radiographic films of clinical study patients at pre-operative and post-operative time points. ODE has committed to an expeditious review of the PMA amendment and agreed to issue a determination on whether the PMA is approvable no later than 180 days after submission of the PMA amendment. The company intends to renew the DRP process if the PMA amendment fails to result in a reversal of ODE’s previous not approvability determination.
Commenting on this development, Robert Palmisano, president and chief executive officer, stated, “Since inception of the DRP process, Wright and ODE were encouraged by the FDA Ombudsman to continue discussing alternative ways to resolve the dispute. These discussions proceeded slowly but gathered steam in recent days as the timeline for DRP submissions grew nearer. The result is something we consider to be a good mechanism for moving forward.”
Palmisano continued, “While this development is cause for somewhat greater optimism than we have thus far had reason to embrace, it is important to reiterate that the parties’ positions are still far apart and there is no guarantee this PMA amendment will result in an approval for Augment Bone Graft. Nevertheless, we are pleased we were able to work collaboratively with FDA to identify a path forward that does not require new clinical studies to get to the next approvability determination.”
http://online.wsj.com/article/PR-CO-20140310-909836.html
WMGIZ is a great FDA play, imo. FDA Dispute Resolution Panel is likely better odds of approval of Augment as opposed to traditional FDA Appeal Process. Approval Milestone ($3.50) expires ~ 5 years, and that is a long time for things to materialize. The entire Company / Augment Department could be merged / sold off. Even without approval of Augment in US within 5 years, the revenue milestone payout(s) of $3.00 is a very likely outcome as Augment is being marketed in foreign markets. Please do your own due diligence and this is all in my own opinion. Good luck out there!
Wright Medical Group, Inc. to Participate in Barclays Global Healthcare Conference
Tuesday, March 11, 2014 at 9:30 a.m. Eastern Time
Wright Medical Group, Inc. (WMGI) announced today that it will be participating in the Barclays Global Healthcare Conference on Tuesday, March 11, 2014, at the Loews Miami Beach Hotel in Miami Beach, Florida. Robert Palmisano, president and chief executive officer, will present at 9:30 a.m. Eastern Time.
A live audio webcast of the conference presentation, along with the accompanying presentation materials, will be available on Wright’s corporate website at www.wmt.com/corporate, under the “Investor Info” link. The audio webcast and accompanying presentation materials will be archived on this site under the “Investor Presentations” link following the conference.
About Wright Medical
Wright Medical Group, Inc. is a specialty orthopaedic company that provides extremity and biologic solutions that enable clinicians to alleviate pain and restore their patients’ lifestyles. The company is the recognized leader of surgical solutions for the foot and ankle market, one of the fastest growing segments in medical technology, and markets its products in over 60 countries worldwide. For more information about Wright Medical, visit www.wmt.com.
Source: http://finance.yahoo.com/news/wright-medical-group-inc-participate-110000713.html
WMGIZ looking for huge gains, imo. FDA Dispute Resolution Panel is likely better odds of approval of Augment as opposed to traditional FDA Appeal Process. Approval Milestone ($3.50) expires ~ 5 years, and that is a long time for things to materialize. The entire Company / Augment Department could be merged / sold off. Even without approval of Augment in US within 5 years, the revenue milestone payout(s) of $3.00 is a very likely outcome as Augment is being marketed in foreign markets. Please do your own due diligence and this is all in my own opinion. Good luck out there!
WMGIZ is about for launch, imo. FDA Dispute Resolution Panel is likely better odds of approval of Augment as opposed to traditional FDA Appeal Process. Approval Milestone ($3.50) expires ~ 5 years, and that is a long time for things to materialize. The entire Company / Augment Department could be merged / sold off. Even without approval of Augment in US within 5 years, the revenue milestone payout(s) of $3.00 is a very likely outcome as Augment is being marketed in foreign markets. Please do your own due diligence and this is all in my own opinion. Good luck out there!
WMGIZ FDA Dispute Resolution Panel in May is likely better odds of approval of Augment as opposed to traditional FDA Appeal Process. Approval Milestone ($3.50) expires ~ 5 years, and that is a long time for things to materialize. The entire Company / Augment Department could be merged / sold off. Even without approval of Augment in US within 5 years, the revenue milestone payout(s) of $3.00 is a very likely outcome as Augment is being marketed in foreign markets. Please do your own due diligence and this is all in my own opinion. Good luck out there!
WMGIZ is a great opportunity, imo. FDA Dispute Resolution Panel is likely better odds of approval of Augment as opposed to traditional FDA Appeal Process. Approval Milestone ($3.50) expires ~ 5 years, and that is a long time for things to materialize. The entire Company / Augment Department could be merged / sold off. Even without approval of Augment in US within 5 years, the revenue milestone payout(s) of $3.00 is a very likely outcome as Augment is being marketed in foreign markets. Please do your own due diligence and this is all in my own opinion. Good luck!
WMGIZ is a great entry point here, imo. FDA Dispute Resolution Panel is likely better odds of approval of Augment as opposed to traditional FDA Appeal Process. Approval Milestone ($3.50) expires ~ 5 years, and that is a long time for things to materialize. The entire Company / Augment Department could be merged / sold off. Even without approval of Augment in US within 5 years, the revenue milestone payout(s) of $3.00 is a very likely outcome as Augment is being marketed in foreign markets. Please do your own due diligence and this is all in my own opinion. Good luck out there!
The sales milestones are based upon "All products contributed by Biomimetic", not just sales of Augment. These revenue milestones will undoubtedly be achieved, imo. The CVR's will more than likely see $3.00 once the Biomimetic Sales milestones are met, imo. $6.50 with FDA approval of Augment.
$1.50 per share upon the achievement of $40 million in trailing twelve month sales for all products contributed by BioMimetic;
$1.50 per share upon the achievement of $70 million in trailing twelve month sales for all products contributed by BioMimetic.
Source: http://phx.corporate-ir.net/phoenix.zhtml?c=129751&p=irol-newsArticle&ID=1760038&highlight=
"Our global biologics business grew 5% on a constant currency basis in the fourth quarter due to growth in our international biologics business driven primarily by sales of Augment Bone Graft in Australia."
Source: http://seekingalpha.com/article/2044843-wright-medical-groups-ceo-discusses-q4-2013-results-earnings-call-transcript
More upside potential @ WMGIZ than with WMGI , IMO.
WMGIZ is a great entry point here, imo. FDA Dispute Resolution Panel is likely better odds of approval of Augment as opposed to traditional FDA Appeal Process. Approval Milestone ($3.50) expires ~ 5 years, and that is a long time for things to materialize. The entire Company / Augment Department could be merged / sold off. Even without approval of Augment in US within 5 years, the revenue milestone payout(s) of $3.00 is a very likely outcome as Augment is being marketed in foreign markets. Please do your own due diligence and this is all in my own opinion. Good luck out there!
WMGIZ is a great entry point here, imo. FDA Dispute Resolution Panel is likely better odds of approval of Augment as opposed to traditional FDA Appeal Process. Approval Milestone ($3.50) expires ~ 5 years, and that is a long time for things to materialize. The entire Company / Augment Department could be merged / sold off. Even without approval of Augment in US within 5 years, the revenue milestone payout(s) of $3.00 is a very likely outcome as Augment is being marketed in foreign markets. Please do your own due diligence and this is all in my own opinion. Good luck out there!
BioMimetic Therapeutics, Inc. Initiates Enrollment in Augment™ Chronic Tendinopathy Clinical Trial
Product Candidate Aimed at Large Tendinosis Market
FRANKLIN, Tenn.--(BUSINESS WIRE)-- BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) today announced it initiated enrollment in a Phase II clinical trial to assess the safety and efficacy of Augment™ Chronic Tendinopathy (ACT) as a treatment for lateral epicondylitis, commonly known as tennis elbow. The randomized, controlled trial is expected to enroll up to 100 patients at seven clinical sites in the U.S. and will evaluate the safety and therapeutic potential of escalating doses of a one-time injection of pure recombinant human platelet-derived growth factor (rhPDGF-BB) homodimer solution into the extensor carpi radialis brevis (ECRB), the tendon in the elbow that is generally the source of pain in tennis elbow. The product candidate is aimed at the large tendinosis market for which there is significant unmet clinical need with limited effective long-term treatments currently available.
“We have seen promising pre-clinical data with ACT and believe the initiation of this Phase II dose finding clinical trial is the logical next step in the development of our sports medicine program,” said Dr. Samuel Lynch, BioMimetic president and CEO. “ACT has the potential to help millions of patients suffering from painful inflammation of the tendon at the outer border of the elbow resulting from overuse of lower arm muscles or trauma.”
Study Design
The Phase II trial is designed as a randomized, ascending dose, double-blinded, placebo controlled, multi-center study. The trial is expected to enroll up to 100 patients ranging from 21 – 80 years of age, who will receive a single injection into the ECRB. The injection will consist of either a placebo or one of four different doses of rhPDGF-BB.
The primary efficacy endpoints will be derived from a combination of pain and disability assessments as measured by the Visual Analog Scale (VAS), Disabilities of the Arm, Shoulder and Hand (DASH) Score and the Patient Rated Tennis Elbow Evaluation (PRTEE), along with sincerity of effort measured by grip strength testing. These clinical outcome measures will be used to detect changes in pain and function up to 24 weeks from baseline. Adverse event reporting, including incidence, relationship with treatment and severity will be recorded throughout the study to evaluate safety of the drug. The product candidate will be reviewed by the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), which regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs.
The study is currently open for enrollment, and more information can be found at www.clinicaltrials.gov. The Company anticipates completing enrollment around year end 2013.
Lateral Epicondylitis
Augment Chronic Tendinopathy (ACT) is being developed to treat chronic tendon injuries, or tendinosis. The target indication for this clinical trial is lateral epicondylitis, commonly referred to as tennis elbow. Lateral Epicondylitis is an inflammation of the tendons that join the forearm muscles on the outside of the elbow. The forearm muscles and tendons become damaged from overuse, or in some cases trauma, leading to pain and tenderness on the outside of the elbow. It is estimated that lateral epicondylitis currently affects one to three percent of the total U.S. population (or approximately three to nine million people), and there is no decisive effective standard of care. Various conservative treatment options are available and include topical and oral non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroid injections, and autologous blood injection (PRP). These conservative treatment options may be effective in short term pain relief and return to function, but studies have shown that a significant portion of patients treated with conservative therapies continue to have recurrent symptoms. Additionally, none of the currently available therapies address the fundamental need to enhance healing at the tendon-to-bone interface and improve long-term outcomes. Thus, lateral epicondylitis is an indication that not only represents a large market opportunity, but it is also one with a significant unmet clinical need. The Company believes there is an opportunity for rhPDGF-BB to fulfill this unmet clinical need and is currently testing this hypothesis in the clinic.
About BioMimetic Therapeutics
BioMimetic Therapeutics (NASDAQ: BMTI) is a biotechnology company specializing in the development and commercialization of clinically proven products to promote the healing of musculoskeletal injuries and diseases, including therapies for orthopedics, sports medicine and spine applications. All Augment® branded products are based upon recombinant human platelet-derived growth factor (rhPDGF-BB), which is a bio-engineered form of PDGF, one of the body's principal agents to stimulate and direct healing and regeneration. Through the commercialization of this patented technology, BioMimetic seeks to become the leading company in the field of regenerative medicine by providing new treatment options for the repair of bone, cartilage, tendons and ligaments.
BioMimetic has received regulatory approvals to market Augment® Bone Graft in Canada, Australia and New Zealand for use in hindfoot and ankle fusion indications. Augment is pending regulatory decisions in the U.S. and European Union for similar indications. The Company also markets a bone graft substitute line of products for orthopedic indications called AugmatrixTM Biocomposite Bone Graft.
On November 19, 2012, BioMimetic and Wright Medical Group, Inc. entered into a definitive agreement for a business combination of the two companies. The transaction will combine BioMimetic’s breakthrough biologics platform and pipeline with Wright’s established sales force and product portfolio to further accelerate growth opportunities in Wright’s Extremities business. The merger is subject to a vote by BioMimetic shareholders, and, if approved, is expected to close in the first quarter of 2013.
For further information contact Kearstin Patterson, senior director of corporate communications, at 615-236-4419.
Important Additional Information Regarding the Transaction
In connection with the proposed transaction, Wright filed a registration statement on Form S-4 (the “Form S-4”) with the Securities and Exchange Commission (“SEC”) on December 20, 2012, but such registration statement has not been declared effective by the SEC. BioMimetic will be mailing a proxy statement/prospectus for its stockholders and each will be filing other documents regarding the proposed transaction with the SEC. BEFORE MAKING ANY VOTING OR INVESTMENT DECISION, BIOMIMETIC STOCKHOLDERS AND INVESTORS ARE URGED TO READ THE PROXY STATEMENT AND OTHER RELEVANT MATERIALS CAREFULLY IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THE DOCUMENTS WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND BIOMIMETIC. Investors and stockholders may obtain copies of the proxy statement and other relevant documents filed with the SEC by BioMimetic free of charge at the SEC’s web site at www.sec.gov. In addition, investors and stockholders may obtain copies of the proxy statement and other relevant documents filed with the SEC by BioMimetic (when they are available) by going to BioMimetic’s Investor Relations page on its corporate website at www.biomimetics.com.
BioMimetic, Wright and their respective directors and executive officers and other persons may be deemed to be participants in the solicitation of proxies in respect of the proposed transaction. Information regarding BioMimetic’s executive officers and directors, and their beneficial ownership of BioMimetic’s common stock as of April 12, 2012 is available in BioMimetic’s proxy statement for its 2012 annual meeting of stockholders, which was filed with the SEC on April 27, 2012. Information regarding Wright’s executive officers and directors is available in Wright’s proxy statement for its 2012 annual meeting of stockholders and its current reports on Form 8-K, which were filed with the SEC on March 27, 2012, August 3, 2012 and November 6, 2012, respectively. Other information regarding the interests of such potential participants in the proxy solicitation are included in the Form S-4 and will be contained in the proxy statement and other relevant materials to be filed with the SEC when they become available.
Forward-looking Statements
This press release contains forward-looking statements about our future results of operations and financial position, product development programs, business strategy, plans and objectives of management for future operations that are not historical facts. The words “may,” “continue,” “estimate,” “intend,” “plan,” “will,” “believe,” “project,” “expect,” “anticipate,” “optimistic” and similar expressions may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. There are many important factors that could cause actual results to differ materially from those indicated in the forward-looking statements, including that: (i) the Food and Drug Administration may not approve Augment Chronic Tendinopathy and (ii) despite the Company’s future marketing and commercialization efforts, Augment Chronic Tendinopathy may not achieve broad market acceptance. Further, BioMimetic’s actual results and the timing and outcome of events may differ materially from those expressed in or implied by the forward-looking statements because of risks detailed in BioMimetic’s recent annual and quarterly reports filed with the Securities and Exchange Commission (SEC), including those factors discussed under the caption "Risk Factors" in the Company’s Annual Report on Form 10-K filed with the SEC on March 13, 2012, which are incorporated in this press release by this reference. Except as required by law, BioMimetic undertakes no responsibility for updating the information contained in this press release beyond the published date, whether as a result of new information, future events or otherwise, and has no policy of doing so.
BioMimetic Therapeutics, Inc.
Kearstin Patterson
Senior Director of Corporate Communications
615-236-4419 (office)
615-517-6112 (mobile)
kpatterson@biomimetics.com
Source: BioMimetic Therapeutics, Inc.
BioMimetic Therapeutics, Inc. (NASDAQ:BMTI) Investor Files Lawsuit to Halt Buyout
A lawsuit was filed by an investor in shares of BioMimetic Therapeutics, Inc. (NASDAQ:BMTI) in effort to block the proposed takeover and current NASDAQ:BMTI stockholders should contact the Shareholders Foundation.
San Diego, CA -- (SBWIRE) -- 11/28/2012 -- An investor in shares of BioMimetic Therapeutics, Inc. (NASDAQ:BMTI) filed a lawsuit against directors of BioMimetic Therapeutics in effort to stop the proposed buyout of BioMimetic Therapeutics by Wright Medical Group.
Investors who purchased shares of BioMimetic Therapeutics, Inc. (NASDAQ:BMTI) prior to November 19, 2012, and currently hold any of those NASDAQ:BMTI shares have certain options and should contact the Shareholders Foundation at mail(at)shareholdersfoundation.com or call +1(858) 779 - 1554.
The plaintiff alleges that the defendants breached their fiduciary duties owed NASDAQ:BMTI stockholders by agreeing to sell the company too cheaply via an unfair process to Wright Medical Group, Inc.
On November 19, 2012, the Wright Medical Group, Inc. (NASDAQ: WMGI) and BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) announced that they have entered into an agreement for a business combination of Wright Medical Group and BioMimetic Therapeutics. Under the terms of the agreement, the transaction has a total potential value for BioMimetic shareholders of approximately $380 million, or $12.97 per share, based on Wright’s closing stock price on Friday, November 16, 2012. Each share of BioMimetic common stock will be converted into the right to receive an upfront payment of $1.50 in cash and 0.2482 shares of Wright common stock. The upfront payment values BioMimetic at approximately $190 million, or $6.47 per share, based on Wright’s closing stock price on November 16, 2012. Each BioMimetic share will also receive one tradable Contingent Value Right (CVR), which entitles its holder to receive additional cash payments of up to $6.50 per share, which are payable upon receipt of FDA approval of Augment® Bone Graft and upon achieving certain revenue milestones.
The CVR payments to BioMimetic shareholders are structured as follows:
- $3.50 per share upon FDA approval of Augment® Bone Graft;
- $1.50 per share upon the achievement of $40 million in trailing twelve month sales for all products contributed by BioMimetic;
- $1.50 per share upon the achievement of $70 million in trailing twelve month sales for all products contributed by BioMimetic.
However, the plaintiff alleges that the offer is unfair to NASDAQ:BMTI stockholders and undervalues BioMimetic Therapeutics, Inc. Indeed shares of BioMimetic Therapeutics, Inc. (NASDAQ:BMTI) traded as high as $14.07 per share in April 2011 and at least one analyst has set the high target price of NASDAQ:BMTI shares at $7.50 per share. Furthermore, so the plaintiff, BioMimetic Therapeutics, Inc. on the verge of a major breakthrough.
Those who are current investors in BioMimetic Therapeutics, Inc. (NASDAQ:BMTI), have certain options and should contact the Shareholders Foundation.
Contact:
Shareholders Foundation, Inc.
Joelle Day
3111 Camino Del Rio North - Suite 423
92108 San Diego
Phone: +1-(858)-779-1554
Fax: +1-(858)-605-5739
mail@shareholdersfoundation.com
Source: http://www.sbwire.com/press-releases/biomimetic-therapeutics-inc-nasdaqbmti-investor-files-lawsuit-to-halt-buyout-183410.htm
BioMimetic Investor Says $380M Buyout Deal Doesn't Cut It
By Jamie Santo
Wilmington (November 26, 2012, 9:43 PM ET) -- A BioMimetic Therapeutics Inc. investor launched a putative class action Wednesday protesting the orthopedic therapy company's planned $380 million buyout by Wright Medical Technology Inc., claiming the deal greatly undervalues a company on the verge of a major breakthrough.
Filed by shareholder Menachem Maiman in Delaware court, the complaint alleges that BioMimetic's board breached its fiduciary duty by attempting to sell the orthopedic and sports-medicine therapy company “by means of an unfair process and for an unfair price.”
The proposed deal would shortchange shareholders because it...
Source: http://www.law360.com/articles/396225/biomimetic-investor-says-380m-buyout-deal-doesn-t-cut-it
Wright Medical Group, Inc. and BioMimetic Therapeutics, Inc. Enter into Agreement to Combine Businesses
Transaction Will Add Breakthrough Biologics Platform and Pipeline to Further Accelerate Growth Opportunities in Wright’s Extremities Business
Upfront Purchase Price Payment of $190 Million in Cash and Stock Plus Contingent Payments of up to $190 Million
Wright to Host Conference Call Today at 10:00 a.m. Central Time
Press Release: Wright Medical Group, Inc. and BioMimetic Therapeutics, Inc
ARLINGTON, Tenn. & FRANKLIN, Tenn.--(BUSINESS WIRE)--
Wright Medical Group, Inc. (WMGI) and BioMimetic Therapeutics, Inc. (BMTI) announced today that they have entered into a definitive agreement for a business combination of Wright and BioMimetic, both publicly traded, Tennessee-based companies. Wright is an orthopedics company with a market-leading lower extremities franchise. BioMimetic is focused on developing regenerative medicine products to promote the healing of musculoskeletal injuries and diseases with a novel protein therapeutic product, Augment® Bone Graft, under late stage FDA review as a replacement for autologous bone graft in foot and ankle fusions. The transaction will combine BioMimetic’s breakthrough biologics platform and pipeline with Wright’s established sales force and product portfolio, to further accelerate growth opportunities in Wright’s Extremities business.
Under the terms of the agreement, the transaction has a total potential value for BioMimetic shareholders of approximately $380 million, or $12.97 per share, based on Wright’s closing stock price on Friday, November 16, 2012. Each share of BioMimetic common stock will be converted into the right to receive an upfront payment of $1.50 in cash and 0.2482 shares of Wright common stock. The upfront payment values BioMimetic at approximately $190 million, or $6.47 per share, based on Wright’s closing stock price on November 16, 2012. Each BioMimetic share will also receive one tradable Contingent Value Right (CVR), which entitles its holder to receive additional cash payments of up to $6.50 per share, which are payable upon receipt of FDA approval of Augment® Bone Graft and upon achieving certain revenue milestones.
Any contingent milestone payments will be paid in cash. The CVR payments to BioMimetic shareholders are structured as follows:
$3.50 per share upon FDA approval of Augment® Bone Graft;
$1.50 per share upon the achievement of $40 million in trailing twelve month sales for all products contributed by BioMimetic;
$1.50 per share upon the achievement of $70 million in trailing twelve month sales for all products contributed by BioMimetic.
The latter two sales milestone payments cannot be made sooner than 24 and 36 months post-closing of the transaction, respectively.
The transaction is expected to close in the first quarter of 2013 and is subject to customary closing conditions, including BioMimetic shareholder approval. The transaction received the unanimous approval of the board of directors of both Wright and BioMimetic. In addition, several key shareholders of BioMimetic have evidenced their support of the transaction by entering into agreements to vote in favor of the transaction.
Robert Palmisano, President and Chief Executive Officer of Wright, commented, “We believe this transaction will significantly accelerate the continued transformation of our business as well as our strategy of building a world-class biologics platform and growing our foot and ankle business at well above market growth rates. BioMimetic’s products complement our existing biologics product portfolio, and, if approved by the FDA as we expect, Augment® Bone Graft will provide us with a unique solution for the U.S. hindfoot and ankle fusion market that leverages the distribution capabilities of Wright’s dedicated foot and ankle sales organization and our physician training capabilities.”
Dr. Samuel Lynch, President and Chief Executive Officer of BioMimetic Therapeutics, added, “BioMimetic is delighted to partner with a company that shares our commitment to building a world-class biologics platform. We believe that Augment® Bone Graft will become an important new therapeutics option to improve patient outcomes in hindfoot and ankle fusion procedures, and that Wright Medical with its leadership position in the foot and ankle market is the ideal partner to accelerate the rapid adoption of our products around the world.”
BioMimetic’s Augment® product line is based on recombinant human platelet-derived growth factor (rhPDGF-BB), a synthetic copy of one of the body’s principal healing agents. In May 2011, the FDA’s Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee voted favorably on Augment® Bone Graft’s safety, efficacy and benefit to risk profile for its use as an alternative to autograft in hindfoot and ankle fusions. In January 2012, BioMimetic announced receipt of a post-panel non-approvable letter requesting additional information in a PMA amendment. In June 2012, BioMimetic submitted a responsive PMA amendment, and the product is currently pending a final FDA regulatory decision. If approved, Augment® Bone Graft will be the first clinically proven protein therapeutic to come to the orthopedics market in a decade, offering the potential to reinforce surgical bone repair in hindfoot and ankle fusion procedures effectively, which translates into an estimated market opportunity believed to be approximately $300 million annually in the U.S. Augment® Bone Graft is currently available for sale as an alternative to autograft in Canada for foot and ankle fusion indications and in Australia and New Zealand for hindfoot and ankle fusion indications.
Although Wright cannot finalize the purchase price allocation and fair value assessment of the contingent consideration until the closing, and thus cannot yet assess the exact impact on its future GAAP earnings, Wright anticipates that the transaction will be dilutive to adjusted EBITDA until the second full-year post-FDA approval of Augment® Bone Graft and accretive thereafter. Wright will provide additional information on the financial impact of this transaction after the closing.
In connection with this transaction, J.P. Morgan Securities LLC and Wilson Sonsini Goodrich & Rosati, a Professional Corporation advised Wright Medical, and Goldman, Sachs & Co. and Ropes & Gray LLP advised BioMimetic Therapeutics.
Conference Call and Webcast
Wright Medical will host a conference call today, November 19, 2012, beginning at 10:00 a.m. Central Time (11:00 a.m. Eastern Time) to discuss the BioMimetic transaction, followed by a question and answer session.
The conference call will be available to interested parties through a live audio webcast at www.wmt.com, where it will be archived and accessible for approximately 12 months. The live dial-in number for the call is 800-591-6930 (U.S.) or 617-614-4908 (International). The participant passcode is “Wright.”
If you do not have access to the Internet and want to listen to an audio replay of the conference call, dial 888-286-8010 (U.S.) or 617-801-6888 (International) and enter passcode 47252247. The audio replay will be available beginning at 12:00 p.m. Central Time on Monday, November 19, 2012 until Monday, November 27, 2012.
About Wright Medical
Wright Medical Group, Inc. (WMGI) is a global orthopaedic medical device company and a leading provider of surgical solutions for the foot and ankle market. Wright Medical specializes in the design, manufacture and marketing of devices and biologic products for extremity, hip and knee repair and reconstruction. Wright Medical has been in business for more than 60 years and markets its products in over 60 countries worldwide. For more information about Wright Medical, visit the Wright Medical’s website at www.wmt.com.
About BioMimetic Therapeutics, Inc.
BioMimetic Therapeutics, Inc. (BMTI) is a biotechnology company specializing in the development and commercialization of clinically proven products to promote the healing of musculoskeletal injuries and diseases, including therapies for orthopedics, sports medicine and spine applications. All Augment® branded products are based upon recombinant human platelet-derived growth factor (rhPDGF-BB), which is an engineered form of PDGF, one of the body’s principal agents to stimulate and direct healing and regeneration. Through the commercialization of this patented technology, BioMimetic seeks to become the leading company in the field of regenerative medicine by providing new treatment options for the repair of bone, cartilage, tendons and ligaments.
BioMimetic has received regulatory approvals to market Augment® Bone Graft in Canada, Australia and New Zealand for use in hindfoot and ankle fusion indications. Augment® is pending regulatory decisions in the U.S. and European Union for similar indications. BioMimetic also markets a bone graft substitute line of products for orthopedic indications called Augmatrix™ Biocomposite Bone Graft. For more information about BioMimetic, visit BioMimetic’s website at www.biomimetics.com.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This press release may contain “forward-looking statements” as defined under U.S. federal securities laws. These statements reflect management’s current knowledge, assumptions, beliefs, estimates, and expectations and express management’s current view of future performance, results, and trends. Forward looking statements may be identified by their use of terms such as anticipate, believe, could, estimate, expect, intend, may, plan, predict, project, will, and other similar terms. Forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. In addition to those described below, forward looking statements contained in this press release include, without limitation, statements concerning the possibility of FDA approval of Augment Bone Graft, statements regarding market acceptance of, and expected annual market demand for Augment Bone Graft, statements regarding the expected impact of the transaction with BioMimetic on Wright’s adjusted EBITDA and other financial results, and statements about the timing and expected benefits of the transaction. The reader should not place undue reliance on forward-looking statements. Such statements are made as of the date of this press release, and we undertake no obligation to update such statements after this date. In addition to those described above, risks and uncertainties that could cause our actual results to materially differ from those described in forward-looking statements are discussed in our filings with the Securities and Exchange Commission (including those described in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2011 and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2012, in each case under the heading “Risk Factors” and elsewhere in such filings). By way of example and without implied limitation, such risks and uncertainties include: the failure of BioMimetic stockholders to adopt the merger agreement or the failure of either Wright or BioMimetic to meet any of the other conditions to the closing of the transaction, the failure to realize the anticipated benefits from the transaction or delay in realization thereof, future actions of the United States Attorney’s office, the FDA, the Department of Health and Human Services or other U.S. or foreign government authorities that could delay, limit or suspend our development, manufacturing, commercialization and sale of products, or result in seizures, injunctions, monetary sanctions or criminal or civil liabilities; any actual or alleged breach of the Corporate Integrity Agreement to which we are subject through September 2015 which could expose us to significant liability including exclusion from Medicare, Medicaid and other federal healthcare programs, potential criminal prosecution, and civil and criminal fines or penalties; adverse outcomes in existing product liability litigation; new product liability claims; inadequate insurance coverage; the possibility of private securities litigation or shareholder derivative suits; demand for and market acceptance of our new and existing products; potentially burdensome tax measures; lack of suitable business development opportunities; product quality or patient safety issues; challenges to our intellectual property rights; geographic and product mix impact on our sales; our inability to retain key sales representatives, independent distributors and other personnel or to attract new talent; inventory reductions or fluctuations in buying patterns by wholesalers or distributors; inability to realize the anticipated benefits of restructuring initiatives; negative impact of the commercial and credit environment on us, our customers and our suppliers; and the potentially negative effect of our ongoing compliance enhancements on our relationships with customers, and on our ability to deliver timely and effective medical education, clinical studies, and new products.
ADDITIONAL INFORMATION ABOUT THIS TRANSACTION
This press release may be deemed to be solicitation material regarding the proposed business combination of Wright and BioMimetic. In connection with the proposed transaction, Wright intends to file with the SEC a registration statement on Form S-4, which will include a proxy statement/prospectus and other relevant materials in connection with the proposed transaction, and each of Wright and BioMimetic intend to file with the SEC other documents regarding the proposed transaction. The proxy statement/prospectus and this press release are not offers to sell Wright securities and are not soliciting an offer to buy Wright securities in any state where the offer and sale is not permitted. The final proxy statement/prospectus will be mailed to the stockholders of BioMimetic. INVESTORS AND SECURITY HOLDERS OF BIOMIMETIC ARE URGED TO READ THE PROXY STATEMENT/PROSPECTUS (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) AND THE OTHER RELEVANT MATERIAL CAREFULLY IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT WRIGHT AND BIOMIMETIC AND THE PROPOSED TRANSACTION.
The proxy statement/prospectus and other relevant materials (when they become available), and any and all documents filed with the SEC, may be obtained free of charge at the SEC’s web site at www.sec.gov. In addition, investors and security holders may obtain free copies of the documents filed with the SEC by Wright by directing a written request to Wright Medical Group, Inc, 5677 Airline Road, Arlington, TN 38002, Attention: Investor Relations, and by BioMimetic by directing a written request to BioMimetic Therapeutics, Inc., 389 Nichol Mill Lane, Franklin, TN 37067, Attention: Investor Relations.
BioMimetic and its respective executive officers and directors and other persons, including Wright and its respective executive officers and directors, may be deemed to be participants in the solicitation of proxies from its stockholders in connection with the proposed transaction. Information about the executive officers and directors of BioMimetic and their ownership of BioMimetic common stock is set forth in its annual report on Form 10-K for the year ended December 31, 2011, filed with the SEC on March 13, 2012 and the proxy statement for BioMimetic’s 2012 annual meeting of stockholders, filed with the SEC on April 27, 2012. Information about the executive officers and directors of Wright Medical Group is set forth in its annual report on Form 10-K for the year ended December 31, 2011, filed with the SEC on February 24, 2012 and the proxy statement for Wright Medical Group’s 2012 annual meeting of stockholders, filed with the SEC on March 27, 2012. Certain directors and executive officers of BioMimetic and other persons may have direct or indirect interests in the merger due to securities holdings, pre-existing or future indemnification arrangements and rights to severance payments if their employment is terminated prior to or following the transaction. If and to the extent that any of the BioMimetic participants will receive any additional benefits in connection with the transaction, the details of those benefits will be described in the proxy statement/prospectus relating to the transaction. Investors and security holders may obtain additional information regarding the direct and indirect interests of BioMimetic and its executive officers and directors in the transaction by reading the proxy statement/prospectus regarding the transaction when it becomes available.
Contact:
Wright Medical Group, Inc.
Julie D. Tracy, 901-290-5817 (office)
Sr. Vice President, Chief Communications Officer
julie.tracy@wmt.com
or
BioMimetic Therapeutics, Inc.
Kearstin Patterson, 615-236-4419 (office)
mobile: 615-517-6112
Sr. Director of Corporate Communications
kpatterson@biomimetics.com
Source: http://finance.yahoo.com/news/wright-medical-group-inc-biomimetic-113000874.html
The longer it takes for auction results to be released, the higher the winning bid will be, imo. GLTA
"more than 20 possible buyers have signed confidentiality agreements"
A bidding war is great news for EK longs, imo.
Gaiam Acquiring Vivendi Entertainment for $13.4 Million
Lifestyle and fitness media distributor Gaiam Inc. March 15 said it is acquiring independent distributor Vivendi Entertainment from parent Universal Music Group for $13.5 million plus net working capital.
Los Angeles-based Vivendi Entertainment posted disc and digital unit sales of about 21 million for $200 million in revenue in 2011, according to Vivendi. It has distribution rights with several independent content providers, including WWE, Classic Media, RHI Entertainment, National Geographic, Shout Factory, Nassar Entertainment Group and NFL Productions, among others.
“By combining operations, we elevate the company to a powerhouse independent distributor with a library of over 7,000 titles,” Gaiam chairman Jyrka Rysavy said.
The new company will be called Gaiam Vivendi Entertainment.
Boulder, Colo.-based Gaiam said it expecting to recognize $25 million in annual revenue and gross profit from the transaction, which is expected to close later this month.
Gaiam is the only independent direct media distributor with Target Stores, Walmart and Kmart, among others. Gaiam expects to generate significant operational and financial synergies, including reduced third-party distribution costs, post-production costs and digital distribution costs, as well as the elimination of redundant overhead, replication, warehousing and other costs, all of which are projected to drive significant margin expansion.
In addition to mass merchandisers, Gaiam targets specialty retailers in the book, grocery, toy, and health and wellness segments representing approximately 62,000 retailers and 14,600 stores within stores, along with digital and on-demand services.
“This transaction materially strengthens our existing media distribution services platform, making the combined entity the third largest non-theatrical content distributor in the United States,” Gaiam CEO Lynn Powers said.
This ranks Gaiam only behind Warner and about even with Lionsgate in non-theatrical distribution, Rysavy said, adding the combined company makes Gaiam the largest independent distributor in the United States.
It was not immediately clear if there would be any layoffs following the merger of operations between the two companies.
Powers and Rysavy said they expect to continue the same distribution deals Vivendi already has with its content providers.
“We’ve already started negotiations with Vivendi’s partners to ensure long-term contracts,” Powers said.
Rysavy pointed out that Gaiam’s direct relationships with Target, Walmart and other retailers should be attractive to the labels that Vivendi distributes.
“We have twice as many doors than anyone in the market,” he said. “It’s an upside for those brands.”
In the company’s financial call made hours after the announcement, Gaiam posted a fourth-quarter (ended Dec. 31) loss of $18.5 million due largely to a non-cash impairment charge of $22.5 million. Without the charge, Gaiam posted net income of $1.4 million compared to net income of $4.2 million during the prior-year period.
The company saw better news in net revenue for the quarter, which increased 15.1% year-over-year to $95.9 million from $83.3 million from the same quarter in 2011. Net revenue for the year was essentially flat at $274.8 million from $274.3 the prior year.
The fourth quarter was impacted in part by DVD market contractions, Powers said.
Company executives seem unfazed by the loss, with Powers saying that 2011 was “a year of repositioning and redefinition” for the company and that 2012 is expected to be a “pivotal year” with continued growth throughout. She said early results for the first quarter already show the company is on that path of growth.
Source: http://www.homemediamagazine.com/studios/gaiam-acquiring-vivendi-entertainment-134-million-26699
The forming of a common equity committee is great news for EK longs! There is a good possibility money will be left over for commons from he patent / asset sales, especially with the recent events in regards to the Apple litigation. It seems Chapter 11 was a good move after all as EK is shielded from further attack from Apple, further boosting patent values. Another positive outcome for commons would be ownership in the new Kodak. Hopefully sans dilution, as there should be more than enough money to pay off the bondholders, imo.
"The ad hoc group wants a chance to counter Citigroup’s financing proposal with one that its members believe would be more competitive."
Looking better every day for EK longs!!!!!!!!!!!!
"$EKDKQ TPHedgegroup's evaluation of Kodak expects the company to emerge from bankruptcy protection in late 2012, with common equity in tact"
Source: http://twitter.com/#!/tphedgegroup/statuses/169398322208047104
"Kodak’s assets and liabilities indicate there is at least $979 million ($3.63 per share) of value (net of all debt and legacy liabilities) available for common shareholders."
Kodak Investor Forms Shareholder Committee
NEW YORK, February 2, 2012 — Wapiti Partners, L.P. beneficial owner of more than 1,000,000 common shares of Eastman Kodak announced today that it formed an ad-hoc equity committee of common shareholders. The committee was formed to protect the substantial interests of common shareholders and will seek to organize an effort to ask the United States Trustee to appoint an official equity committee. Wapiti is taking this action because Wapiti’s analysis of Kodak’s assets and liabilities indicate there is at least $979 million ($3.63 per share) of value (net of all debt and legacy liabilities) available for common shareholders. The recent history of bankrupt companies demonstrates that a minimal amount of effort and fiduciary responsibility is invested in protecting the interests of common shareholders. When a significant value is available for the common stock and shareholders are organized and form an equity committee, the Courts are less likely to ignore the value owed to common shareholders.
Kodak is an "asset-rich company" which was forced to file for bankruptcy because of a liquidity crisis and the market valuation of Kodak is anchored by this liquidity crisis. At the same time no effort to form an equity committee is noticeable in the public record. Wapiti believes this is a potentially lethal combination for shareholders. Lance Laifer, CEO of Wapiti said, "The danger of this, as we have seen in past bankruptcies such as Six Flags, is the court will anchor its thinking on valuation based on market valuation. The situation will be exacerbated by testimonies of supposed experts who are paid by constituencies, such as bondholders, standing to benefit from lower valuations. Many times in these situations, shareholders do not even get to participate in the valuation-charade-debate-game. Excuses are given but the primary reason shareholders do not get to participate in this game is because they do not get organized until too late in the bankruptcy. At that point, bankruptcy judges are reluctant to slow down the bankruptcy-gravy-train, which is loaded with fees for professionals and exorbitant awards of equity and bonuses for management."
Antonio M. Perez, Kodak’s Chairman and CEO recently stated that Kodak is an "asset-rich company". Wapiti’s analysis concurs with Mr. Perez’s statement. In summary, Wapiti valued the assets of Kodak to total at least $6.2 billion and the debt equivalent liabilities of Kodak to total $5.2 billion. Below is the breakdown by primary asset and liability category:
Core Business Line - Valuation: $1.5 billion. Valued at 7X’s 2011 EBITDA. 2011 revenue of $2,297 million and EBITDA of $214 million grew from $2,250 million and $210 million in 2010. By way of comparison: NCR trades at 11.3X’s EBITDA, Diebold, trades at 8.7X’s EBITDA and Verifone trades at 11.4X’s EBITDA. This business line includes Retail Systems Solutions, Document Scanners and Digital Plates.
Growth Business Line - Valuation: $600 million. 2011 Revenue of $1,187 million and EBITDA loss of $415 million. 2010 Revenue of $1,061 million and EBITDA loss of $380. Latest two year EBITDA loss of $795 million. This business line includes Consumer Inkjet, Digital Printing Solutions, Workflow Software and Services and Prepackaging Solutions. Management refers to losses incurred in this business line as a "continued investment in our growth initiatives". On the second quarter 2011 conference call with investors, Mr. Perez stated, "As I said before, consumer inkjet could start making money this quarter if we want it. All we have to do is slow down the growth of printers. Is that the best thing for our shareholders long term? Probably not. That’s why we’re not doing it. We have all our modeling that looks at what is the ideal balancing of investing and getting return, and that’s what we’re following..could we do it differently? Of course we can do it differently. We can do that with any of the investments we have. But our ink gross profit has doubled from last year. Next year (2012) it’s going to be a huge amount of money…It’s a huge number. You will see this is going to be a gorgeous business for this Company." On the third quarter call with investors on November 3, 2011, Mr Perez stated that, "these four growth initiatives are very promising and have tremendous power to create very significant value for our shareholders. They are a central part of Kodak’s transition to a digital, profitable, and sustainable Company." Valuing this business is difficult for Wapiti because of the money losing nature of the businesses to date. Given the lack of transparency of the individual components of this business line Wapiti valued the business based on investments to date.
Manage for Cash/Value Business Line - Valuation: $500 million. 2011 Revenue (ex Intellectual Property) $2,474 million. 2010 Revenue (ex Intellectual Property) $2,474. EBITDA (ex Intellectual Property) not provided. Businesses in this business line include: Digital Capture & Devices, Paper & Output Services, Entertainment Imaging, Commercial Film, Consumer Film, Kodak Gallery and Event Imaging Solutions. Entertainment Imaging, approximately a $700 million revenue business, which has the number one market share in its business and is cash generative is one of the jewels in this business line. This business line was valued on a multiple of revenue basis.To more accurately assess the value of this business line more transparency is required.
Patent Portfolio - Digital Capture and Kodak Imaging Systems - Valuation: $2.4 billion. This portfolio of 1,100 patents (out of Kodak’s total portfolio of 10,700 patents) was valued at $2.2 to $2.6 billion by 284 Partners, LLC as referred to in the Kodak Public Lender Presentation. According to the Wall Street Journal, "Kodak believes the patents could be worth more, as that valuation doesn’t take into account strategic interest from possible suitors."
Patent Portfolio - excluding Digital Capture and Kodak Imaging Systems Patents. Valuation: $150 million. This portfolio of 9,600 patents underlies many of the existing businesses. The company continues to annually spend between $300 million and $500 million in Research & Development efforts. 590 priority applications were filed in 2011 and 483 in 2010.
Kodak brand name for licensing - Valuation: unknown. Under the leadership of Mr. Perez, Kodak has expanded its footprint beyond film. The Kodak brand name, which is one of the most recognizable and favored consumer names in the world, has a halo which can benefit many companies in the technology and electronic industries outside of the businesses which Kodak operates (or has operated) in. Licensing the Kodak name for use on computers, tablets, smartphones, televisions, binoculars, telescopes, e-readers, mp3 players and many others is a considerable opportunity for the company going forward.
Real Estate - Valuation: $207 million. According to the most recent Kodak 10-Q the Company’s Property Plant and Equipment has a book value of $948 million. In its Public Lender Presentation Kodak revealed that the collateral provided for the Term Loan included the Company’s corporate headquarters in Rochester NY and 23 domestic properties in eight states. According to this presentation the net book value of U.S. real property totaled approximately $207 million. Wapiti believes the long held property, a significant portion of which was purchased when George Eastman himself ran the Company, is on the books at a fraction of its true value but will need more information to raise its valuation. Most prominently the Company owns what is reputed to be the Northeast’s largest industrial complex, the 1,200 acre Eastman Business Park, which includes 300 greenfield acres.
NOL and Tax Credits - Valuation: unknown. Kodak currently has approximately $1.9 billion of Net Operating Losses ("NOLs") for U.S. federal income tax purposes and $656 million of foreign tax credits. Wapiti’s analysis assumes that a significant amount of the proceeds from the sale of the Digital Capture and Kodak Imaging Systems patents are not taxed because of losses incurred in settlement payments for Non-U.S. Pension Liabilities and Other Post Employment benefit payments. Any gains on the portfolio which are not shielded by payments for these legacy liabilities are assumed to be shielded by Kodak’s NOLs. The NOL’s and tax credits should be valued based on the present value savings of Kodak’s future income stream. This value should be substantial (close to $500 million or almost $2 per share) but it is too preliminary to be included without access to company projections.
Cash and Cash Equivalents - Valuation: $862 million. Valued at book value on September 30, 2011. This is traditionally a low point in the Company’s cash balance.
Debt and Prepetition Legacy Liabilities - Valuation: $5.2 billion. Comprised of $2,213 million of Pro-Forma Total Debt (see page 22 of Kodak’s Public Lender Presentation); $425 million of trade debt; $1.2 billion in non-U.S. pension liabilities, $1.3 billion of Other Post-Employment Benefit and approximately $100 million in environmental liabilities.
For more information or if you would be interested in serving on an official committee of equity holders please contact Lance Laifer at laifer@gmail.com
lance laifer
Wapiti Capital Management
Source: http://www.prleap.com/pr/185060/
Shareholder class action is great news for EK Longs!!!!!!!!!!!!! imho.
http://ca.reuters.com/article/technologyNews/idCATRE80U1JX20120131
Note to self:
I knew the pensioners and employees would fight in our favor in some form or fashion. Congrats Longs!
"During a two-day meeting of the company's board, management and advisers in mid-December, executives were briefed on how Kodak would fund itself during bankruptcy proceedings should efforts to sell its patents fall short, a person familiar with the matter said. "
Kodak changed lawyers from bankruptcy restructuring firm Jones Day to Sullivan & Cromwell around that same time. My guess is this is old news, lead by Jones Day, and Kodak is currently working with Sullivan & Cromwell and is now focused on selling its patent portfolio outside of bankruptcy, imo.
Hang on EK longs, looks like the shorts are on the run, eom.
lol Looking forward to $wimming in the money courtesy of EK, imo.
Heck yeah!
BK is not even on my radar with EK.
Various stakeholders will not have any of that business..
The way I look at it, EK will grow into a nice nest egg for EK longs, imo.
Long EK / $1.79 Avg. I am pretty exited about future developments with the patent sale / potential sale opportunities, imo.
Better odds than the lotto, imo.