Wright Medical Group, Inc. CVR (WMGIZ)

[Enterprising Investor]

Wright Announces Receipt of FDA Approvable Letter for Augment® Bone Graft Presentation

http://phx.corporate-ir.net/External.File?t=1&item=VHlwZT0yfFBhcmVudElEPTUxNzMxMjF8Q2hpbGRJRD01NTg1MzM=

[Enterprising Investor]

Wright Receives Approvable Letter from FDA for Augment® Bone Graft

[...]

The merger of Wright and Tornier will create a mid-sized growth company uniquely positioned with leading technologies and specialized sales forces in three of the fastest growing areas of orthopaedics – Upper Extremities, Lower Extremities and Biologics. That leadership will be further enhanced by anticipated final U.S. Food and Drug Administration (FDA) premarket approval of Augment® Bone Graft, adding additional depth to what will be one of the most comprehensive extremity product portfolios in the industry as well as providing a platform technology for future new product development. The highly complementary nature of the two businesses will give the combined company significant diversity and scale across a range of geographies and product categories.

As announced separately today, Wright received an Approvable Letter from the FDA for its Premarket Approval Application (PMA) for Augment® Bone Graft. The approvable letter indicates that FDA determined Augment® Bone Graft to be safe and effective as an alternative to autograft for ankle and/or hindfoot fusion indications and is approvable subject to customary preapproval facilities inspections.

Robert Palmisano, president and chief executive officer of Wright, stated, “This combination will create the premier Extremities-Biologics company with a broad global reach. Together, we will have one of the most comprehensive upper and lower extremity product portfolios in the market, extending our leadership position and further accelerating our growth opportunities and path to profitability, all of which we believe will generate long-term value for our shareholders. In addition, this will provide our employees with opportunities for career growth and development as part of a much larger, dynamic organization.”

[...]

Palmisano continued, “Today’s positive news on the approvability of Augment Bone Graft is a major milestone that paves the way for commercialization in the U.S. and further underscores our strength in Biologics. This is expected to be a significant catalyst and meaningful new future growth driver for our business.”

[Enterprising Investor]

Wright Medical Group, Inc. and Tornier N.V. Agree to Merge Creating Premier High-Growth Extremities-Biologics Company (10/27/14)

Combination Will Offer Comprehensive Upper and Lower Extremity Product Portfolio and Broad Global Reach

Further Accelerates Growth Opportunities in Three of the Fastest Growing Areas in Orthopaedics

Adds Significant Scale and Scope to Provide Accelerated Path to Profitability and Stronger Financial Profile

Wright Receives Approvable Letter from FDA for Augment® Bone Graft

MEMPHIS, Tenn. & AMSTERDAM--(BUSINESS WIRE)--Wright Medical Group, Inc. (NASDAQ: WMGI) and Tornier N.V. (NASDAQ: TRNX) announced today that they have entered into a definitive merger agreement under which Wright and Tornier will combine in an all stock transaction with a combined equity value of approximately $3.3 billion.

Under the terms of the agreement, which has been unanimously approved by the boards of directors of both Wright and Tornier, each outstanding share of Wright common stock will be exchanged for 1.0309 ordinary shares of Tornier. Upon completion of the merger, Wright shareholders will own approximately 52% of the shares of the combined company on a fully diluted basis and Tornier shareholders will own approximately 48%. For Tornier shareholders, the exchange ratio implies a per share value for Tornier that represents a 28% premium to Tornier’s closing share price on October 24, 2014, the last trading day prior to the parties entering into the agreement.

Following the closing of the transaction, the combined company will conduct business as Wright Medical Group N.V. and will leverage the global strengths of both product brands as a pure play Extremities-Biologics business. The combined company will have its U.S. headquarters in Memphis, TN, where Wright’s current headquarters is located. Wright Medical Group N.V. will be led by Robert Palmisano, who will become president and chief executive officer of the combined company. David Mowry, Tornier’s president and chief executive officer, will become executive vice president and chief operating officer of the combined company. Wright Medical Group N.V.’s board of directors will be comprised of five representatives from Wright’s existing board and five representatives from Tornier’s existing board, including Robert Palmisano and David Mowry.

The merger of Wright and Tornier will create a mid-sized growth company uniquely positioned with leading technologies and specialized sales forces in three of the fastest growing areas of orthopaedics – Upper Extremities, Lower Extremities and Biologics. That leadership will be further enhanced by anticipated final U.S. Food and Drug Administration (FDA) premarket approval of Augment® Bone Graft, adding additional depth to what will be one of the most comprehensive extremity product portfolios in the industry as well as providing a platform technology for future new product development. The highly complementary nature of the two businesses will give the combined company significant diversity and scale across a range of geographies and product categories.

As announced separately today, Wright received an Approvable Letter from the FDA for its Premarket Approval Application (PMA) for Augment® Bone Graft. The approvable letter indicates that FDA determined Augment® Bone Graft to be safe and effective as an alternative to autograft for ankle and/or hindfoot fusion indications and is approvable subject to customary preapproval facilities inspections.

Robert Palmisano, president and chief executive officer of Wright, stated, “This combination will create the premier Extremities-Biologics company with a broad global reach. Together, we will have one of the most comprehensive upper and lower extremity product portfolios in the market, extending our leadership position and further accelerating our growth opportunities and path to profitability, all of which we believe will generate long-term value for our shareholders. In addition, this will provide our employees with opportunities for career growth and development as part of a much larger, dynamic organization.”

David Mowry, president and chief executive officer of Tornier, added, “Wright shares Tornier’s commitment to serving extremities specialists and building the leading global business in this market. Both companies have built a deep and loyal customer base and have highly complementary product portfolios, positioning the combined entity to deliver meaningful value to our shareholders. We believe that partnered together, Wright and Tornier will become the fastest-growing company in the Extremities-Biologics industry.”

Palmisano continued, “Today’s positive news on the approvability of Augment Bone Graft is a major milestone that paves the way for commercialization in the U.S. and further underscores our strength in Biologics. This is expected to be a significant catalyst and meaningful new future growth driver for our business.”

Both companies will benefit from opportunities to accelerate growth through combined direct sales and distribution networks, a broad product portfolio and deep customer relationships. The joint products, R&D, sales and distribution talent, medical education and relationships will allow an increased focus on the needs of surgeon specialists. Similarly, patients will benefit from dedicated research and development teams that will power enhanced innovation across the combined product portfolio.

Financial Highlights

This stock-for-stock merger allows shareholders of the combined company to benefit from operational and cost synergies. Once integrated, the companies anticipate revenues of the combined business growing in the mid-teens and adjusted EBITDA margins approaching 20% in three to four years.

The amount of cost synergies is expected to be in the range of $40 million to $45 million anticipated to be fully realized by the third year after completion of the transaction. Expense synergy opportunities include: public company expenses, overlapping support function and systems costs, as well as process and vendor consolidation opportunities across the business.

Wright anticipates that the transaction will be accretive to the combined companies’ adjusted EBITDA in the second full-year after completion of the transaction.

Structure

Upon completion of the transaction, the businesses of Wright and Tornier will be combined and incorporated in the Netherlands, where Tornier has been incorporated and headquartered for approximately 8 years. Both companies agreed that maintaining Tornier’s domicile best supported the growth strategy driving the merger. Over the long term, it is anticipated that this structure will provide the company with more accessible cash flow, enhancing its ability to innovate and grow, creating long-term shareholder value.

The U.S. headquarters for the Lower Extremity and Biologics business will be based in Wright’s existing facility in Memphis, TN, and its Augment team will continue to be based at its facility in Franklin, TN. The U.S. headquarters for the Upper Extremity business will be based within Tornier’s existing facility in Bloomington, MN and its U.S. engineering center in Warsaw, IN.

The transaction is expected to be taxable, for U.S. federal income tax purposes, to shareholders of Wright.

The transaction is subject to the customary closing conditions, including the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, as well as Wright and Tornier shareholder approval.

In addition, TMG Holdings Cooperatief U.A., an affiliate of Warburg Pincus, which holds approximately 22% of Tornier’s outstanding ordinary shares, has evidenced its support by entering into an agreement to vote in favor of the transaction.

The transaction is expected to close in the first half of 2015.

An investor presentation will be available on Wright’s investor website at www.wmt.com. More information about the transaction can also be found at www.ExtremitiesLeader.com.

Wright Announces Third Quarter 2014 Revenue and Updates Revenue Guidance

In a separate press release issued today, Wright also announced third quarter 2014 revenue and updated revenue guidance. Wright plans to report its full third quarter financial results and discuss these results in more detail on its third quarter earnings call, which is currently scheduled for November 5, 2014 at 3:30 p.m. Central Time.

Tornier Announces Third Quarter 2014 Revenue and Updates Revenue Guidance

In a separate press release issued today, Tornier also announced third quarter 2014 revenue and updated revenue guidance. Tornier plans to report its full third quarter financial results and discuss these results in more detail on its third quarter earnings call, which is currently scheduled for November 6, 2014 at 3:30 p.m. Central Time.

Advisors

In connection with this transaction, J.P. Morgan Securities LLC and Perella Weinberg Partners LP are serving as financial advisors to Wright, and Ropes & Gray LLP is serving as its legal advisor. BofA Merrill Lynch is serving as financial advisor to Tornier and Willkie Farr & Gallagher LLP and Oppenheimer Wolff & Donnelly LLP are serving as its legal advisors.

Conference Call and Webcast

Wright and Tornier management will host a conference call today, October 27, 2014, beginning at 4:30 p.m. Central Time (5:30 p.m. Eastern Time) to discuss the 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 877-474-9504 (U.S.) or 857-244-7557 (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 25400317. The audio replay will be available beginning at 6:30 p.m. Central Time on Monday, October 27, 2014 until Tuesday, November 4, 2014.

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.

About Tornier

Tornier is a global medical device company focused on providing solutions to surgeons who treat musculoskeletal injuries and disorders of the shoulder, elbow, wrist, hand, ankle and foot. Tornier’s broad offering of over 95 product lines includes joint replacement, trauma, sports medicine, and biologic products to treat the extremities, as well as joint replacement products for the hip and knee in certain international markets. Since its founding approximately 70 years ago, Tornier’s "Specialists Serving Specialists" philosophy has fostered a tradition of innovation, intense focus on surgeon education, and commitment to advancement of orthopaedic technology stemming from its close collaboration with orthopaedic surgeons and thought leaders throughout the world. For more information regarding Tornier, visit www.tornier.com.

Tornier®, Aequalis®, Aequalis Ascend®, Aequalis Ascend® Flex™ and Salto Talaris® are trademarks of Tornier N.V. and its subsidiaries, registered as indicated in the United States, and in other countries. All other trademarks and trade names referred to in this release are the property of their respective owners.

Note on Non-GAAP Financial Measures

Wright and Tornier use non-GAAP financial measures, including EBITDA, as adjusted. Their respective management teams believe that the presentation of these measures provides useful information to investors and that these measures may assist investors in evaluating their respective company’s operations, period over period. EBITDA is calculated by adding back to net income charges for interest, income taxes and depreciation and amortization expenses. While it is not possible to reconcile the adjusted EBITDA forecast in this release to the nearest metric under U.S. generally accepted accounting principles (GAAP) of the combined business without unreasonable effort, the adjusted EBITDA forecast excludes non-cash stock based compensation expense and non-operating income and expense, as well as the expected impact of such items as transaction and transition costs, impacts from the sale of Wright’s OrthoRecon business and costs associated with distributor conversions and non-competes, all of which may be highly variable, difficult to predict and of a size that could have substantial impact on the combined company’s reported results of operations for a period. Investors should consider these non-GAAP measures only as a supplement to, not as a substitute for or as superior to, measures of financial performance prepared in accordance with GAAP.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This press release includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “plan,” “could,” “may,” “will,” “believe,” “estimate,” “forecast,” “goal,” “project,” and other words of similar meaning. Forward-looking statements in this press release include, but are not limited to, statements about the benefits of the transaction; potential synergies and cost savings and the timing thereof; future financial and operating results; the expected timing of the completion of the transaction; the combined company’s plans, objectives, expectations and intentions with respect to future operations, products and services, the approvable status and anticipated final PMA approval of Wright’s Augment® Bone Graft product, and the positive effects such final approval is anticipated to have on the combined business. Each forward-looking statement contained in this press release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, uncertainties as to the timing of the transaction; uncertainties as to whether Tornier shareholders and Wright shareholders will approve the transaction; the risk that competing offers will be made; the possibility that various closing conditions for the transaction may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction, or the terms of such approval; the effects of disruption from the transaction making it more difficult to maintain relationships with employees, customers, vendors and other business partners; the risk that shareholder litigation in connection with the transaction may result in significant costs of defense, indemnification and liability; other business effects, including the effects of industry, economic or political conditions outside of Wright’s or Tornier’s control; the failure to realize synergies and cost-savings from the transaction or delay in realization thereof; the businesses of Wright and Tornier may not be combined successfully, or such combination may take longer, be more difficult, time-consuming or costly to accomplish than expected; operating costs and business disruption following completion of the transaction, including adverse effects on employee retention and on Wright’s and Tornier’s respective business relationships with third parties; transaction costs; actual or contingent liabilities; the adequacy of the combined company’s capital resources; failure or delay in ultimately obtaining FDA approval of Wright’s Augment® Bone Graft for commercial sale in the United States, failure to achieve the anticipated benefits from approval of Augment® Bone Graft, and the risks identified under the heading “Risk Factors” in Wright’s Annual Report on Form 10-K, filed with the SEC on February 27, 2014, and Tornier’s Annual Report on Form 10-K, filed with the SEC on February 21, 2014, as well as both companies’ subsequent Quarterly Reports on Form 10-Q and other information filed by each company with the SEC. Wright and Tornier caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read Wright’s and Tornier’s filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this release, and Wright and Tornier undertake no obligation to update or revise any of these statements. Wright’s and Tornier’s businesses are subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

IMPORTANT ADDITIONAL INFORMATION ABOUT THIS TRANSACTION AND WHERE TO FIND IT

In connection with the proposed merger, Tornier plans to file with the U.S. Securities and Exchange Commission (SEC) a registration statement on Form S-4 that will include a joint proxy statement of Wright and Tornier that also constitutes a prospectus of Tornier. Wright and Tornier will make the joint proxy statement/prospectus available to their respective shareholders. Investors are urged to read the joint proxy statement/prospectus when it becomes available, because it will contain important information. The registration statement, definitive joint proxy statement/prospectus and other documents filed by Tornier and Wright with the SEC will be available free of charge at the SEC’s website (www.sec.gov) and from Tornier and Wright. Requests for copies of the joint proxy statement/prospectus and other documents filed by Wright with the SEC may be made by contacting Julie D. Tracy, Senior Vice President and Chief Communications Officer by phone at [phone] or by email at [e-mail], and request for copies of the joint proxy statement/prospectus and other documents filed by Tornier may be made by contacting Shawn McCormick, Chief Financial Officer by phone at [phone] or by email at [e-mail].

Wright, Tornier, their respective directors, executive officers and employees may be deemed to be participants in the solicitation of proxies from Wright’s and Tornier’s respective shareholders in connection with the proposed transaction. Information about the directors and executive officers of Wright and their ownership of Wright stock is set forth in Wright’s annual report on Form 10-K for the fiscal year ended December 31, 2013, which was filed with the SEC on February 24, 2014 and its proxy statement for its 2014 annual meeting of stockholders, which was filed with the SEC on March 31, 2014. Information regarding Tornier’s directors and executive officers is contained in Tornier’s annual report on Form 10-K for the fiscal year ended December 29, 2013, which was filed with the SEC on February 21, 2014, and its proxy statement for its 2014 annual general meeting of shareholders, which was filed with the SEC on May 16, 2014. These documents can be obtained free of charge from the sources indicated above. Certain directors, executive officers and employees of Wright and Tornier may have direct or indirect interest in the transaction due to securities holdings, vesting of equity awards and rights to severance payments. Additional information regarding the participants in the solicitation of Wright and Tornier shareholders will be included in the joint proxy statement/prospectus.

Contacts

Wright Medical Group, Inc.
Julie D. Tracy, 901-290-5817
Chief Communications Officer
[e-mail]
or
Tornier N.V.
Shawn McCormick, 952-426-7646
Chief Financial Officer
[e-mail]

http://www.businesswire.com/news/home/20141027006367/en/Wright-Medical-Group-Tornier-N.V.-Agree-Merge#.VE65Zol0yUk

[db7]

wow in after hours?

[Enterprising Investor]

Go Wright ahead!

[fredman]

At the Morgan Stanley conference call today, Wright Management stated that they are looking into the possibility of buying back some WMGIZ CVR shares. WMGI is in a great cash position to do this. STRONG BUY! imho.

[fredman]

Our international biologics sales increased 21% as the result of a 44% 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 20% increase in Asia as the result of the addition of a new distribution partner in China in the second quarter of 2013.

Source: http://www.sec.gov/Archives/edgar/data/1137861/000113786114000039/wmgi630201410q.htm

[fredman]

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

[fredman]

“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

[fredman]

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

[jmbell42]

Hello All,

I'm just starting out my Due Diligence on this CVR. Sorry for the totally "newb" questions, but rather than go and re-invent the wheel, I wanted to ask you more knowledgable investors a few questions:

(1) Are we expecting FDA approval? At least prior to the expiration? (6 years post-merger)

(2) I saw a few posters excited about the revenue milestones, so that's why I was searching for any news about the approval question in (1) above. I took a quick look at the chart that dipped from $3.00 down to the 0.20's.. which suggested that I might have missed the boat on the FDA approval milestone.

I haven't seen anything on the web about FDA approval, which makes this a very interesting and compelling value play.

I'm also looking into CYHHZ, but that's more of a litigation CVR play and I'm somewhat jaded about Litigation tracking securities….

Anyway, thanks in advance for your patience and willingness to share information with a newcomer!

Very Best,

Jared

[fredman]

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

[56Chevy]

Marker:

Wright Medical Grp. (WMGIZ)
0.79 up 0.43 (119.44%)
Volume: 731,596

[Enterprising Investor]

Initial stake purchased 8/09/13.

Doubled my position 2/27/14.

[fredman]

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

[fredman]

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

[fredman]

[fredman]

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=

[fredman]

"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

[fredman]

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!

[Enterprising Investor]

WMGIZ is a Contingent Value Right

CVRs are given to shareholders as an additional benefit if a specified event occurs. A CVR is similar to an option. The payoff is contingent.

WMI acquired Biomimetic.The CVRs were provided to shareholders as a "sweetner".

The payoff for WMGIZ is two fold: (1) FDA approval of Augment® Bone Graft ($3.50) and (2) payment streams from sales revenue ($1.50 per share upon the achievement of $40 million in trailing twelve month sales for all products contributed by Biomimetic and $1.50 per share upon the achievement of $70 million in trailing twelve month sales for all products contributed by Biomimetic).

[hot-penguin]

can anybody explain why this ticker has a 'Z' after the WMGI and what is the share structure?

Looks like WMGI is a different ticker for the same company and trades at $24 and only lost 2% yesterday.

[RealGenius]

FDA denial

[AnG5640]

Lol! This one popped up on my scanner due to volume. I'm watching for a bounce......

[alchemytrader]

Whoa whoaawaahh! Whats going on here?

[OceanEagle1]

LOL thanks for some more clues ... remember I was the first person to ever post on this board ...just today, but will watch because we 3-5 people are starting to uncover the DD here ... Thanks again trader
-OE1-

[renoldman]

You guys are kind of funny hoping randomly for $0.40 ... Especially when you don't know what the CRV is based on ....

Here is the information .... so you can have a clue as to what you are looking at.

http://phx.corporate-ir.net/phoenix.zhtml?c=129751&p=irol-newsArticle&ID=1760038&highlight=

"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."

Today: "Wright Medical Group, Inc. Announces Receipt of FDA Not Approvable Letter for Augment® Bone Graft"

Could be a bit of time before $3.50 is realized, if at all.

[AnG5640]

Thanks! I agree...I'm not convinced the bottom has been found yet. I put it on watch.

[OceanEagle1]

Good Job Trader ... nice to see why the huge drop ... still tempted to play it as a bottom-bounce but not unless it drops back into the low 40's Anyway, gonna Member-Mark you Trader!
--Ocean--

[AnG5640]

Must be because of yesterday's news for WMGI...out @ market close...


Wright Medical Group, Inc. Announces Receipt of FDA Not Approvable Letter for Augment® Bone Graft

Wright Medical Group, Inc. (NASDAQ: WMGI) today announced it received a not approvable letter from the Food & Drug Administration (FDA) in response to its Pre-Market Approval (PMA) application for Augment® Bone Graft for use as an alternative to autograft in hindfoot and ankle fusion procedures.

In the letter, FDA states it is “concerned that the population enrolled was predominantly low risk and, therefore, may not have warranted the use of either autograft or Augment Bone Graft.” FDA went on to state it believes that “it will be necessary to perform a new clinical study that evaluates the use of Augment Bone Graft as a substitute for autograft in hindfoot and ankle fusion procedures in a well-defined high-risk target population, where the use of autograft would be clinically warranted.”

In summary, FDA concerns included “the patient population studied in the clinical study, the amount of graft material implanted, and the uncertainty as to whether any graft material would be needed or if the use of no graft material in a fusion procedure of the hindfoot and ankle in the population studied would have achieved similar results.” FDA provided a number of additional observations about the clinical study design and results.

“Needless to say, we are very disappointed by the FDA’s decision to issue a not approvable letter for our PMA application for Augment Bone Graft,” stated Robert Palmisano, president and chief executive officer of Wright. “This is not what we expected, as we believed that all of the FDA’s concerns as outlined in their previous not approvable letter from December 2011 had been fully and thoroughly addressed in the PMA amendment that BioMimetic submitted in June 2012. We are continuing to study the FDA’s position and expect we will work collaboratively with the agency to determine an appropriate path forward.”

Conference Call and Webcast

Wright Medical will host a conference call today, Thursday, August 8, 2013, at 3:30 p.m. Central Time to discuss the FDA letter for Augment® Bone Graft, followed by a question and answer session.

The live dial-in number for the call is 877-280-4955 (U.S.) / 857-244-7312 (International). The participant passcode for the call is “Wright.” To access a simultaneous webcast of the conference call via the internet, go to the “Corporate - Investor Information” section of the Company's website located at www.wmt.com.

A replay of the conference call by telephone will be available starting at 5:30 p.m. Central Time today and continuing through August 15, 2013. To hear this replay, dial 888-286-8010 (U.S.) or 617-801-6888 (International) and enter the passcode 89431004. A replay of the conference call will also be available via the internet starting today and continuing for at least 12 months. To access a replay of the conference call via the internet, go to the “Corporate - Investor Information - Audio Archives” section of the Company's website located at www.wmt.com.

The conference call may include forward-looking statements. See the cautionary information about forward-looking statements in the “Cautionary Note Regarding Forward-Looking Statements” section of this press release.

About Wright Medical

Wright Medical Group, Inc. is a global orthopaedic company that provides 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 and markets its products in over 60 countries worldwide. For more information about Wright Medical, visit www.wmt.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements as defined under U.S. federal securities laws. 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. These forward-looking statements address various matters including statements regarding the potential to work collaboratively with the FDA to determine an appropriate path forward to obtain FDA approval to market Augment® Bone Graft in the U.S. for use as an alternative to autograft in hindfoot and ankle fusion procedures. 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. 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. 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, 2012, and as may be supplemented in our Quarterly Reports on Form 10-Q). By way of example and without implied limitation, such risks and uncertainties include: failure to determine a commercially feasible approach to obtaining FDA approval and decisions by FDA with respect to any proposed approach.

[parker1073]

Friday 08/09/2013 10:51 AM ET - S&P Capital IQ's Research Notes
We cut our target price $2 to $28 on revised price/sales analysis. WMGI received a not approvable letter from the FDA for its Pre-Market Approval application for Augment Bone Graft as an alternative to the patient's own tissue in foot/ankle fusion. The FDA believes patient population in the trials was not at high enough risk. We view probability as low that WMGI will conduct a new trial, which is costly and market size may be too small, though WMGI can appeal. Still, we view extremities business as attractive, and WMGI's cash position as healthy, providing financial flexibility.

[OceanEagle1]

Can we say VOLATILE

[AnG5640]

#2 here! scanner alert also!

[OceanEagle1]

SCANNER ALERT: Call me crazy being the first to post ever on this board but why the huge drop from $3 bucks to now .038 -45 at least that's when this baby started to hit. Im watching to see how much potential this has as a bottom play at this point .... careful traders! But checking my post history in the last week I've had 3 100+% winners so lets see what we have hear!!!!!!
--Ocean--