Form 8-K Wright Medical Group For: May 04
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E-mailUNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
__________________
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
__________________
Date of Report (Date of earliest event reported): May 4, 2016
___________________
WRIGHT MEDICAL GROUP N.V.
(Exact name of registrant as specified in its charter)
The Netherlands | 1-35065 | 98-0509600 |
(State or other jurisdiction of incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) |
Prins Bernhardplein 200 1097 JB Amsterdam, The Netherlands | None |
(Address of principal executive offices) | (Zip Code) |
(+ 31) 20 521 4777
(Registrant’s telephone number, including area code)
Not applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
TABLE OF CONTENTS |
Item 2.02. Results of Operations and Financial Condition.
On May 4, 2016, Wright Medical Group N.V. (Wright) issued a press release announcing financial results for the quarter ended March 27, 2016. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and the information set forth therein is incorporated herein by reference and constitutes a part of this report.
Unless the context otherwise requires, references to "Wright," the "company," "we," "our" or "us" in this report refer to Wright Medical Group N.V. and its subsidiaries. References to "legacy Wright" refer to Wright Medical Group, Inc. and its subsidiaries and references to "legacy Tornier" refer to Tornier N.V. and its subsidiaries, in each case prior to the merger between Wright Medical Group, Inc. and Tornier N.V. (the merger or the Wright/Tornier merger).
Wright is furnishing the information contained in this report, including Exhibit 99.1, pursuant to Item 2.02 of Form 8-K promulgated by the United States Securities and Exchange Commission (SEC). This information shall not be deemed to be filed with the SEC for purposes of Section 18 of the United States Securities Exchange Act of 1934, as amended (Exchange Act), or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any filing under the United States Securities Act of 1933, as amended (Securities Act), except as expressly set forth by specific reference in such filing. By filing this report and furnishing this information, Wright makes no admission as to the materiality of any information contained in this report, including Exhibit 99.1. This report shall not be incorporated into any future filings by Wright under the Securities Act or the Exchange Act.
To supplement our consolidated financial statements prepared in accordance with United States generally accepted accounting principles (GAAP), we use certain non-GAAP financial measures, several of which are included in the press release furnished as Exhibit 99.1 to this report. The press release includes the following non-GAAP financial measures: combined pro forma net sales; combined pro forma net sales, on a constant currency basis; net income from continuing operations, as adjusted; EBITDA from continuing operations, as adjusted; cash earnings, as adjusted; and cash earnings, as adjusted, per diluted share.
For internal budgeting and resource allocation process, our management uses financial information that does not include:
1. | non-cash inventory step-up amortization; |
2. | non-cash interest expense related to our convertible notes due 2017 and convertible notes due 2020 (2017 and 2020 convertible notes); |
3. | mark-to-market adjustments of derivatives; |
4. | transaction and transition costs; |
5. | BioMimetic contingent value right (CVR) mark-to-market adjustments; and |
6. | income tax effects of the foregoing. |
Additionally, for internal budgeting process and evaluation of net sales performance, management uses net sales on a constant currency basis. To measure net sales on a constant currency basis, it is necessary to remove the impact of changes in foreign currency exchange rates, which affects the comparability and trend of net sales. Net sales, on a constant currency basis, is calculated by translating current period results at prior period average foreign currency exchange rates.
For internal budgeting and resource allocation process, management uses pro forma measures to evaluate performance when certain acquisitions or dispositions occur. Historical data reflects results of acquired businesses only after the acquisition dates, while pro forma data enhances comparability of financial information between periods by adjusting the data as if the acquisitions or dispositions occurred at the beginning of the preceding year or period.
For internal budgeting and resource allocation process, management also uses EBITDA, EBITDA, as adjusted, and cash earnings, as adjusted. EBITDA is calculated by adding back to net loss from continuing operations charges for interest, benefit (provision) from income taxes, depreciation, and amortization expenses. EBITDA, as adjusted, is calculated by excluding non-cash share-based compensation expense, non-operating income and expense, as well as the applicable adjustments numbered above, from EBITDA. Cash earnings, as adjusted, is calculated by adding back to net loss from continuing operations charges for non-cash amortization expenses, net of taxes, as well as the applicable adjustments numbered above.
We use these non-GAAP financial measures in making operating decisions because we believe these measures provide meaningful supplemental information regarding our core operational performance and give us a better understanding of how we should invest in research and development activities and how we should allocate resources to both ongoing and prospective business initiatives. We use these measures to help make budgeting and spending decisions, for example, between research and development and selling, general and administrative expenses. Additionally, management is evaluated on the basis of some of these non-GAAP financial measures when determining achievement of their performance incentive plan compensation targets.
Further, these non-GAAP financial measures facilitate management’s internal comparisons to both our historical operating results and to our competitors’ operating results by factoring out potential differences caused by charges not related to our regular, ongoing business, including without limitation, non-cash charges, certain large and unpredictable charges, acquisitions and dispositions, legal settlements, and tax positions.
As described above, we exclude the following items from one or more of our non-GAAP financial measures for the following reasons:
Foreign currency impact on net sales. We excluded the foreign currency impact on net sales compared to prior period from our non-GAAP measure, primarily because it is not reflective of our ongoing operating results, and it is not used by management for internal budgeting process and evaluation of net sales performance. We further believe that excluding this item is useful to investors in that it allows for period-over-period comparability.
Non-cash inventory step-up amortization. We excluded inventory step-up amortization associated with our acquisitions from our non-GAAP measures, primarily because they are not reflective of ongoing operating results, and they are not used by management to assess the core profitability of our business operations. Additionally, because these are non-cash expenses, they do not impact our operational performance, liquidity, or our ability to invest in research and development and to fund acquisitions and capital expenditures. We further believe that excluding this item is useful to investors in that it allows for period-over-period comparability.
Non-cash interest expense related to the 2017 and 2020 convertible notes. We excluded the non-cash interest expense associated with the amortization of the debt discount related to our 2017 and 2020 convertible notes from our non-GAAP financial measures, primarily because it is a non-cash expense. We believe that it is useful to investors to understand our operational performance, liquidity, and our ability to invest in research and development and to fund acquisitions and capital expenditures. While interest expense associated with the amortization of the debt discount constitutes an ongoing and recurring expense, such expense is excluded from our non-GAAP financial measures because it is not an expense that requires cash settlement and is not used by management to assess the core profitability of our business operations. We further believe that excluding this item is useful to investors in that it allows for period-over-period comparability.
Mark-to-market adjustment of derivatives. We excluded the adjustment of the mark-to-market adjustments on derivatives from our non-GAAP financial measures, primarily because it is not reflective of our ongoing operating results, and it is not used by management to assess the core profitability of our business operations. We further believe that excluding this item is useful to investors in that it allows for period-over-period comparability.
Transaction and transition costs. We excluded the transaction and transition costs associated with acquisitions and mergers, including the Wright/Tornier merger and the divestiture of the OrthoRecon business, from our non-GAAP financial measures, primarily because they are not reflective of our ongoing operating results, and they are not used by management to assess the core profitability of our business operations. We further believe that excluding this item is useful to investors in that it allows for period-over-period comparability.
BioMimetic CVR mark-to-market adjustments. We excluded the adjustment of the mark-to-market adjustments on the contingent value rights associated with acquired assets and liabilities from our BioMimetic acquisition from our non-GAAP financial measures, primarily because they are not reflective of our ongoing operating results, and they are not used by management to assess the core profitability of our business operations. We further believe that excluding this item is useful to investors in that such exclusion allows for period-over-period comparability.
Income tax effects of the foregoing. This amount is used to present each of the amounts described above, except for foreign currency exchange rate impact on net sales, on an after-tax basis consistent with the presentation of net income, as adjusted.
For internal budgeting and resource allocation process, our management also uses certain pro forma financial information. We use pro forma data to evaluate performance when certain acquisitions or dispositions occur. Historical data reflects results of acquired businesses only after the acquisition dates while pro forma data enhances comparability of financial information between periods by adjusting the data as if the acquisitions or dispositions occurred at the beginning of the preceding year or period.
These non-GAAP financial measures are not in accordance with, or an alternative for, GAAP measures and may be different from non-GAAP financial measures used by other companies. In addition, these non-GAAP financial measures are not based on any comprehensive or standard set of accounting rules or principles. Accordingly, the calculation of our non-GAAP financial measures may differ from the definitions of other companies using the same or similar names limiting, to some extent, the
usefulness of such measures for comparison purposes. Non-GAAP financial measures have limitations in that they do not reflect all of the amounts associated with our financial results as determined in accordance with GAAP. These measures should only be used to evaluate our financial results in conjunction with the corresponding GAAP measures. Accordingly, we qualify our use of non-GAAP financial information in a statement when non-GAAP financial information is presented.
All of the historical non-GAAP financial measures used in our press release are reconciled to the most directly comparable GAAP measure. With respect to our 2016 financial guidance regarding adjusted EBITDA from continuing operations and adjusted cash earnings per share from continuing operations, we cannot provide a quantitative reconciliation to the most directly comparable GAAP measure without unreasonable effort due to our inability to make accurate projections and estimates related to certain information needed to calculate some of the adjustments. However, we have described in the press release the anticipated differences between these non-GAAP financial measures and the most directly comparable GAAP measure qualitatively.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit Number | Description | |
99.1 | Press release issued by Wright Medical Group N.V. on May 4, 2016 announcing financial results for the quarter ended March 27, 2016 (furnished herewith) | |
Cautionary Note Regarding Forward-Looking Statements
This Current Report on Form 8-K, including the exhibit hereto, includes forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “could,” “may,” “will,” “believe,” “estimate,” “forecast,” “goal,” “target,” “project,” "continue," "outlook," “guidance,” "future,” other words of similar meaning and the use of future dates. Forward-looking statements in this report include, but are not limited to, statements about the company’s anticipated financial results for 2016, including net sales, adjusted EBITDA from continuing operations and adjusted cash earnings per share from continuing operations; anticipated sales and cost synergies and dis-synergies, the timing thereof, and level of risk of achievement; the company’s expectations regarding its recently launched new shoulder replacement, total ankle replacement and biologics products and the anticipated sales growth of its lower extremities, upper extremities and biologics businesses; the benefits of its recently completed merger with Tornier and integration efforts and progress; and the company’s anticipated growth opportunities. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. 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, the failure to integrate the businesses and realize net sales synergies and cost-savings from the merger with Tornier or delay in realization thereof; operating costs and business disruption as a result of the merger, including adverse effects on employee retention and sales force productivity and on business relationships with third parties; integration costs; actual or contingent liabilities; the adequacy of the company’s capital resources and need for additional financing; the timing of regulatory approvals and introduction of new products; physician acceptance, endorsement, and use of new products; failure to achieve the anticipated benefits from approval of AUGMENT® Bone Graft; the effect of regulatory actions, changes in and adoption of reimbursement rates; product liability claims and product recalls; pending and threatened litigation; risks associated with international operations and expansion; fluctuations in foreign currency exchange rates; other business effects, including the effects of industry, economic or political conditions outside of the company’s control; reliance on independent distributors and sales agencies; competitor activities; changes in tax and other legislation; and the risks identified under the heading “Risk Factors” in Wright’s Annual Report on Form 10-K for the year ended December 27, 2015 filed by Wright with the SEC on February 23, 2016. Investors should not place considerable reliance on the forward-looking statements contained in this report. You are encouraged to read Wright’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 report speak only as of the date of this report, and Wright undertakes no obligation to update or revise any of these statements. Wright’s business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: May 4, 2016
WRIGHT MEDICAL GROUP N.V. | ||
By: /s/ Lance A. Berry | ||
Name: Lance A. Berry | ||
Title: Senior Vice President and Chief Financial Officer | ||
WRIGHT MEDICAL GROUP N.V. CURRENT REPORT ON FORM 8-K EXHIBIT INDEX |
Exhibit Number | Description | Method of Filing |
99.1 | Press release issued by Wright Medical Group N.V. on May 4, 2016 announcing financial results for the quarter ended March 27, 2016 | Furnished herewith |
FOR IMMEDIATE RELEASE |  |
Investors and Media: | |
Wright Medical Group N.V. Julie D. Tracy | |
Sr. VP, Chief Communications Officer (901) 290-5817 (office) | |
Wright Medical Group N.V. Reports 2016 First Quarter Financial Results and Increases 2016 Guidance
First Quarter 2016 Net Sales of $181 Million As Reported
First Quarter 2016 Global Extremities and Biologics Net Sales Increased 14% on a Pro Forma Constant Currency Basis
First Quarter 2016 Net Loss From Continuing Operations of $39 Million; Significant Progress in Non-GAAP Adjusted EBITDA of $16 Million
Company Increases Full-Year 2016 Net Sales Guidance to $705 Million to $715 Million and Full-Year 2016 Non-GAAP Adjusted EBITDA Guidance to $30 Million to $35 Million
AMSTERDAM, The Netherlands - May 4, 2016 - Wright Medical Group N.V. (NASDAQ: WMGI) today reported financial results for its first quarter ended March 27, 2016 and provided updated 2016 guidance.
As previously announced, Wright Medical Group, Inc. and Tornier N.V. completed their merger on October 1, 2015, and, in accordance with U.S. GAAP, legacy Wright’s historical results of operations replaced legacy Tornier’s historical results of operations for all periods prior to the merger and the results of the two legacy businesses have been consolidated only from that date forward. This release and Wright’s website at ir.wright.com contain certain unaudited non-GAAP combined pro forma financial results for Wright Medical Group N.V. which give effect to the merger as if it had occurred on the first day of fiscal 2014.
Net sales totaled $181.0 million during the first quarter ended March 27, 2016. Combined pro forma net sales totaled $162.1 million during the first quarter of 2015. On pro forma constant currency basis, global extremities and biologics net sales grew 14%. Reconciliations of all historical non-GAAP financial measures used in this release to the most comparable U.S. GAAP measures can be found in the attached financial tables.
Robert Palmisano, president and chief executive officer, commented, “All of our most important financial results exceeded our expectations. Global extremities and biologics pro forma constant currency net sales growth of 14%, adjusted EBITDA of $16.2 million and adjusted gross margins of 77.4% reflect the strength of our markets and our unique position in them. We continued to successfully execute our merger integration plans and with the early success we are seeing, we believe we are well positioned to continue our strong business momentum and to deliver on our synergy commitments as we progress through 2016.”
Palmisano continued, “Highlights in the quarter included strong contributions from the ongoing rollout of our SIMPLICITI shoulder system and AEQUALIS ASCEND FLEX convertible shoulder system and the
ongoing launch of the INFINITY total ankle replacement system, which drove 31% sales growth in U.S. total ankle replacement for the first quarter of 2016. In addition, our U.S. biologics business grew 48% in the quarter, driven by the ongoing commercial activities for AUGMENT Bone Graft. Biologics is now the fastest growing segment of our business. We expect all of these products, which are still early in commercial rollout, will continue to be growth engines in 2016.”
Palmisano further commented, “Despite the dis-synergy headwinds we expect to see for the remainder of the year, we are increasing our full year net sales and adjusted EBITDA guidance. The strength of our core upper extremities and lower extremities businesses, plus our ability to execute on cost synergies ahead of schedule, gives us the confidence to increase our outlook for the full year. We will continue to focus on executing our integration plans to realize our full potential and believe that the positive progress we have made since the merger close sets us up well for continued strong net sales growth and significant margin expansion this year, next year and beyond.”
Net loss from continuing operations for the first quarter of 2016 totaled $39.3 million, or $(0.38) per diluted share.
The company’s net loss from continuing operations for the first quarter of 2016 included the after-tax effects of $11.1 million of transaction and transition costs, $11.4 million of inventory step-up amortization, a gain of $6.6 million related to mark-to-market adjustments on derivatives, $7.1 million of non-cash interest expense related to its 2017 convertible notes and 2020 convertible notes, and a $5.3 million unrealized loss related to mark-to-market adjustments on contingent value rights (CVRs) issued in connection with the BioMimetic acquisition.
The company's first quarter 2016 net loss from continuing operations, as adjusted for the above items, was $12.8 million. The company's first quarter 2016 adjusted EBITDA, as defined in the non-GAAP to GAAP reconciliation provided later in this release, was $16.2 million. The attached financial tables include reconciliations of non-GAAP measures to the most comparable U.S. GAAP measures.
Cash and cash equivalents totaled $121.4 million as of the end of the first quarter of 2016.
Palmisano concluded, “Following our merger, our increased size and scale allows us to leverage strong revenue growth into even stronger EBITDA growth. We have multiple opportunities through a robust new product pipeline to further accelerate our growth, continue to expand our markets and gain market share.”
Outlook
The company anticipates net sales for full-year 2016 of approximately $705 million to $715 million, an increase from the previous guidance range of $695 million to $705 million. The midpoint of this net sales guidance range assumes extremities and biologics pro forma constant currency growth of 14%, excluding the impact of revenue dis-synergies of approximately $25 million to $30 million.
The company anticipates 2016 adjusted EBITDA from continuing operations, as described in the non-GAAP to GAAP reconciliation provided later in this release, of $30.0 million to $35.0 million, an increase from the previous guidance range of $20 million to $30 million. This range reflects approximately $10 million to $15 million of potential cost synergies expected to be realized in 2016 from the merger with Tornier.
The company anticipates adjusted cash earnings per share from continuing operations, including share-based compensation, as described in the non-GAAP to GAAP reconciliation provided later in this release, for full-year 2016 of $(0.64) to $(0.59) per diluted share.
The company estimates approximately 103 million diluted weighted average ordinary shares outstanding for fiscal year 2016.
The company's adjusted EBITDA from continuing operations target is measured by adding back to net income/loss from continuing operations charges for interest, income taxes, depreciation and amortization expenses, non-cash share-based compensation expense and non-operating income and expense. Additionally, the company’s adjusted EBITDA from continuing operations target excludes possible future acquisitions; other material future business developments; and due diligence, transaction and transition costs associated with acquisitions and divestitures. Further, this adjusted EBITDA from continuing operations target excludes any expenses, earnings or losses related to legacy Wright’s divested OrthoRecon business and legacy Tornier’s divested ankle and silastic toe products.
The company’s adjusted cash earnings per share from continuing operations target is measured by adding back to net income/loss from continuing operations charges for non-cash amortization expenses, net of taxes. Note that as a result of the company’s relatively low effective tax rate due to the valuation allowance impacting a substantial portion of the company’s income/loss, the company is currently estimating the tax effect on amortization expense at 0%. Additionally, this adjusted cash earnings per share from continuing operations target excludes possible future acquisitions; other material future business developments; non-cash interest expense associated with the 2017 and 2020 convertible notes; due diligence, transaction and transition costs associated with acquisitions and divestitures; mark-to-market adjustments to contingent value rights (CVRs); and non-cash mark-to-market derivative adjustments.
The company's anticipated ranges for net sales, adjusted EBITDA from continuing operations, and adjusted cash earnings per share from continuing operations are forward-looking statements, as are any other statements that anticipate or aspire to future events or performance. They are subject to various risks and uncertainties that could cause the company's actual results to differ materially from the anticipated targets. The anticipated targets are not predictions of the company's actual performance. See the cautionary information about forward-looking statements in the “Cautionary Note Regarding Forward-Looking Statements” section of this release.
Supplemental Financial Information
To view the first quarter of 2016 supplemental financial information, visit ir.wright.com. For updated information on Wright Medical Group N.V. segment reporting changes and preliminary, combined non-GAAP pro forma historical financial information, including first quarter of 2016, please refer to the presentation posted on Wright’s website at ir.wright.com in the “Financial Information” section.
Internet Posting of Information
Wright routinely posts information that may be important to investors in the “Investor Relations” section of its website at www.wright.com. The company encourages investors and potential investors to consult the Wright website regularly for important information about Wright.
Conference Call and Webcast
As previously announced, Wright will host a conference call starting at 3:30 p.m. Central Time today.
The live dial-in number for the call is (877) 516-3529 (U.S.) / (281) 973-6135 (Outside U.S.). The participant passcode for the call is “Wright.” A simultaneous webcast of the call will be available via Wright’s corporate website at www.wright.com.
A replay of the call will be available beginning at 5:30 p.m. Central Time on May 4, 2016 through May 11, 2016. To hear this replay, dial (855) 859-2056 (U.S.) / (404) 537-3406 (Outside U.S.) and enter code 68872809. 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 “Investor Relations - Presentations/Calendar” section of the company’s corporate website located at www.wright.com.
The conference call may include a discussion of non-GAAP financial measures. Reference is made to the most directly comparable GAAP financial measures, the reconciliation of the differences between the two financial measures, and the other information included in this release, the Current Report on Form 8-K filed with the U.S. Securities and Exchange Commission today, or otherwise available in the “Investor Relations - Supplemental Financial Information” section of the company's corporate website located at www.wright.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 release.
About Wright Medical Group N.V.
Wright Medical Group N.V. is a global medical device company focused on extremities and biologics products. The company is committed to delivering innovative, value-added solutions improving quality of life for patients worldwide and is a recognized leader of surgical solutions for the upper extremities (shoulder, elbow, wrist and hand), lower extremities (foot and ankle) and biologics markets, three of the fastest growing segments in orthopaedics. For more information about Wright, visit www.wright.com.
WRIGHT®, INFINITY®, AUGMENT®, TORNIER®, AEQUALIS®, AEQUALIS ASCEND®, AEQUALIS ASCEND® FLEX™, and SIMPLICITI® are trademarks of Wright Medical Group N.V. or its affiliates, 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.
Non-GAAP Financial Measures
To supplement the company’s consolidated financial statements prepared in accordance with U.S. generally accepted accounting principles (GAAP), the company uses certain non-GAAP financial measures in this release. Reconciliations of the non-GAAP financial measures used in this release to the most comparable U.S. GAAP measures for the respective periods can be found in tables later in this release. Wright’s non-GAAP financial measures include combined pro forma net sales; combined pro forma net sales, excluding the impact of foreign currency; net income, as adjusted; EBITDA, as adjusted; cash earnings, as adjusted; and cash earnings, as adjusted, per diluted share. The company's management believes that the presentation of these measures provides useful information to investors. These measures may assist investors in evaluating the company's operations, period over period. While pro forma data gives effect to the merger with Tornier as if it had occurred on the first day of fiscal 2014 and enhances comparability of financial information between periods, pro forma data is not indicative of the results that actually would have been obtained if the merger had occurred as of the beginning of the fiscal year.
Wright’s non-GAAP financial measures exclude such items as non-cash interest expense related to the company's 2017 convertible notes and 2020 convertible notes, net gains and losses on mark-to-market adjustments on and settlements of derivative assets and liabilities, mark-to-market adjustments on CVRs, transaction and transition costs, all of which may be highly variable, difficult to predict and of a size that could have substantial impact on the company's reported results of operations for a period. Management uses these measures internally for evaluation of the performance of the business, including the allocation of resources and the evaluation of results relative to employee performance compensation targets. Investors should consider these non-GAAP financial 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 release includes forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “could,” “may,” “will,” “believe,” “estimate,” “forecast,” “goal,” “target,” “project,” “continue,” “outlook,” “guidance,” “future,” other words of similar meaning and the use of future dates. Forward-looking statements in this release include, but are not limited to, statements about the company’s anticipated financial results for 2016, including net sales, adjusted EBITDA from continuing operations and adjusted cash earnings per share from continuing operations; anticipated sales and cost synergies and dis-synergies, the timing thereof, and level of risk of achievement; the company’s expectations regarding its recently launched new shoulder replacement, total ankle replacement and biologics products and the anticipated sales growth of its lower extremities, upper extremities and biologics businesses; the benefits of its recently completed merger with Tornier and integration efforts and progress; and the company’s anticipated growth opportunities. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward-looking statement contained in this 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, the failure to integrate the businesses and realize net sales synergies and cost savings from the merger with Tornier or delay in realization thereof; operating costs and business disruption as a result of the merger, including adverse effects on employee retention and sales force productivity and on business relationships with third parties; integration costs; actual or contingent liabilities; the adequacy of the company’s capital resources and need for additional financing; the timing of regulatory approvals and introduction of new products; physician acceptance, endorsement, and use of new products; failure to achieve the anticipated benefits from approval of AUGMENT® Bone Graft; the effect of regulatory actions, changes in and adoption of reimbursement rates; product liability claims and product recalls; pending and threatened litigation; risks associated with international operations and expansion; fluctuations in foreign currency exchange rates; other business effects, including the effects of industry, economic or political conditions outside of the company’s control; reliance on independent distributors and sales agencies; competitor activities; changes in tax and other legislation; and the risks identified under the heading “Risk Factors” in Wright’s Annual Report on Form 10-K for the year ended December 27, 2015 filed by Wright with the SEC on February 23, 2016. Investors should not place considerable reliance on the forward-looking statements contained in this release. Investors are encouraged to read Wright’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 release speak only as of the date of this release, and Wright undertakes no obligation to update or revise any of these statements. Wright’s business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
--Tables Follow--
Wright Medical Group N.V.
Condensed Consolidated Statements of Operations
(in thousands, except per share data--unaudited)
Three months ended | |||||||
March 27, 2016 | March 31, 2015 | ||||||
Net sales | $ | 181,027 | $ | 77,934 | |||
Cost of sales | 52,315 | 19,125 | |||||
Gross profit | 128,712 | 58,809 | |||||
Operating expenses: | |||||||
Selling, general and administrative | 138,911 | 82,199 | |||||
Research and development | 12,554 | 7,117 | |||||
Amortization of intangible assets | 6,627 | 2,614 | |||||
Total operating expenses | 158,092 | 91,930 | |||||
Operating loss | (29,380 | ) | (33,121 | ) | |||
Interest expense, net | 11,854 | 7,649 | |||||
Other (income) expense, net | (1,068 | ) | 5,312 | ||||
Loss from continuing operations before income taxes | (40,166 | ) | (46,082 | ) | |||
(Benefit) provision for income taxes | (891 | ) | 166 | ||||
Net loss from continuing operations | $ | (39,275 | ) | $ | (46,248 | ) | |
Loss from discontinued operations, net of tax | (8,717 | ) | $ | (3,500 | ) | ||
Net loss | $ | (47,992 | ) | $ | (49,748 | ) | |
Net loss from continuing operations per share, basic (1) | $ | (0.38 | ) | $ | (0.88 | ) | |
Net loss from continuing operations per share, diluted (1) | $ | (0.38 | ) | $ | (0.88 | ) | |
Net loss per share, basic (1) | $ | (0.47 | ) | $ | (0.95 | ) | |
Net loss per share, diluted (1) | $ | (0.47 | ) | $ | (0.95 | ) | |
Weighted-average number of shares outstanding-basic (1) | 102,704 | 52,437 | |||||
Weighted-average number of shares outstanding-diluted (1) | 102,704 | 52,437 | |||||
_______________________________
(1) | The prior year balances were converted to meet post-merger valuations. |
Wright Medical Group N.V.
Consolidated Net Sales Analysis
(dollars in thousands--unaudited)
Three months ended | ||||||||||
March 27, 2016 | March 31, 2015 | % change | ||||||||
U.S. | ||||||||||
Lower extremities | 55,278 | 41,988 | 31.7 | % | ||||||
Upper extremities | 50,001 | 3,874 | 1,190.7 | % | ||||||
Biologics | 17,128 | 11,133 | 53.8 | % | ||||||
Sports med & other | 2,137 | 491 | 335.2 | % | ||||||
Total extremities & biologics | 124,544 | 57,486 | 116.7 | % | ||||||
Large joint | 26 | — | N/A | |||||||
Total U.S. | $ | 124,570 | $ | 57,486 | 116.7 | % | ||||
International | ||||||||||
Lower extremities | 15,542 | 11,796 | 31.8 | % | ||||||
Upper extremities | 20,975 | 1,917 | 994.2 | % | ||||||
Biologics | 4,198 | 4,492 | (6.5 | )% | ||||||
Sports med & other | 4,032 | 2,243 | 79.8 | % | ||||||
Total extremities & biologics | 44,747 | 20,448 | 118.8 | % | ||||||
Large joint | 11,710 | — | N/A | |||||||
Total International | $ | 56,457 | $ | 20,448 | 176.1 | % | ||||
Global | ||||||||||
Lower extremities | 70,820 | 53,784 | 31.7 | % | ||||||
Upper extremities | 70,976 | 5,791 | 1,125.6 | % | ||||||
Biologics | 21,326 | 15,625 | 36.5 | % | ||||||
Sports med & other | 6,169 | 2,734 | 125.6 | % | ||||||
Total extremities & biologics | 169,291 | 77,934 | 117.2 | % | ||||||
Large joint | 11,736 | — | N/A | |||||||
Total net sales | $ | 181,027 | $ | 77,934 | 132.3 | % | ||||
Wright Medical Group N.V.
Reconciliation of Non-GAAP Combined Pro Forma Net Sales to Net Sales
(unaudited)
Three months ended | |||||||||||||||
March 31, 2015 | |||||||||||||||
Standalone Wright Medical Group, Inc. | Standalone Tornier N.V., recast (1) | Revenues divested (2) | Non-GAAP combined pro forma net sales | ||||||||||||
U.S. | |||||||||||||||
Lower extremities | $ | 41,988 | $ | 11,443 | $ | (3,897 | ) | $ | 49,534 | ||||||
Upper extremities | 3,874 | 39,413 | — | 43,287 | |||||||||||
Biologics | 11,133 | 463 | — | 11,596 | |||||||||||
Sports med & other | 491 | 1,605 | — | 2,096 | |||||||||||
Total extremities & biologics | 57,486 | 52,924 | (3,897 | ) | 106,513 | ||||||||||
Large joint | — | 46 | — | 46 | |||||||||||
Total U.S. | $ | 57,486 | $ | 52,970 | $ | (3,897 | ) | $ | 106,559 | ||||||
International | |||||||||||||||
Lower extremities | $ | 11,796 | $ | 2,602 | $ | — | $ | 14,398 | |||||||
Upper extremities | 1,917 | 18,115 | — | 20,032 | |||||||||||
Biologics | 4,492 | 116 | — | 4,608 | |||||||||||
Sports med & other | 2,243 | 2,183 | — | 4,426 | |||||||||||
Total extremities & biologics | 20,448 | 23,016 | — | 43,464 | |||||||||||
Large joint | — | 12,106 | — | 12,106 | |||||||||||
Total International | $ | 20,448 | $ | 35,122 | $ | — | $ | 55,570 | |||||||
Global | |||||||||||||||
Lower extremities | $ | 53,784 | $ | 14,045 | $ | (3,897 | ) | $ | 63,932 | ||||||
Upper extremities | 5,791 | 57,528 | — | 63,319 | |||||||||||
Biologics | 15,625 | 579 | — | 16,204 | |||||||||||
Sports med & other | 2,734 | 3,788 | — | 6,522 | |||||||||||
Total extremities & biologics | 77,934 | 75,940 | (3,897 | ) | 149,977 | ||||||||||
Large joint | — | 12,152 | — | 12,152 | |||||||||||
Total net sales | $ | 77,934 | $ | 88,092 | $ | (3,897 | ) | $ | 162,129 | ||||||
_______________________________
(1) | Legacy Tornier product line sales have been recast to reflect the reclassification of cement, instruments and freight from the historical Tornier product line "Large Joints and Other" to the product line associated with those revenues that will be utilized for future revenue reporting. |
(2) | To reduce from Tornier’s historical sales the U.S. sales associated with Tornier’s Salto Talaris and Salto XT ankle replacement products and silastic toe replacement products. |
Wright Medical Group N.V.
Supplemental Combined Pro Forma Net Sales Information
(unaudited)
First Quarter 2016 sales growth/(decline) | |||||
U.S. combined pro forma | Int'l combined pro forma constant currency | Int'l combined pro forma | Global combined pro forma constant currency | Global combined pro forma | |
Product line | |||||
Lower extremities | 12% | 12% | 8% | 12% | 11% |
Upper extremities | 16% | 8% | 5% | 13% | 12% |
Biologics | 48% | (4%) | (9%) | 33% | 32% |
Sports med & other | 2% | (5%) | (9%) | (3%) | (5%) |
Total extremities & biologics | 17% | 7% | 3% | 14% | 13% |
Large joint | (43%) | (1%) | (3%) | (1%) | (3%) |
Total net sales | 17% | 5% | 2% | 13% | 12% |
Wright Medical Group N.V.
Reconciliation of Non-GAAP Cash Earnings Per Share to Net Loss from Continuing Operations
(in thousands, except per share data--unaudited)
Three months ended | |||
March 27, 2016 | |||
Net loss from continuing operations, as reported | $ | (39,275 | ) |
Other reconciling items: | |||
Inventory step-up amortization (1) | 11,360 | ||
Non-cash interest expense on 2017 & 2020 convertible notes | 7,056 | ||
Derivatives mark-to-market adjustments | (6,641 | ) | |
Transaction and transition costs (2) | 11,100 | ||
CVR mark-to-market adjustments | 5,324 | ||
Tax effect of reconciling items | (1,705 | ) | |
Non-GAAP net loss from continuing operations, as adjusted | $ | (12,781 | ) |
Add back amortization of intangible assets | 6,627 | ||
Non-GAAP cash earnings | $ | (6,154 | ) |
Weighted-average basic shares outstanding | 102,704 | ||
Non-GAAP cash earnings per share | $ | (0.06 | ) |
_______________________________
(1) | Impacting Gross Profit. |
(2) | Impacting Gross Profit; Selling, General, and Administrative expense; and Research and Development expense for $0.1 million, $10.8 million, and $0.2 million, respectively. |
Wright Medical Group N.V.
Reconciliation of Non-GAAP Adjusted EBITDA to Net Loss from Continuing Operations
(in thousands, except per share data--unaudited)
Three months ended | |||
March 27, 2016 | |||
Net loss from continuing operations | $ | (39,275 | ) |
Interest expense, net | 11,854 | ||
Benefit from income taxes | (891 | ) | |
Depreciation | 13,222 | ||
Amortization | 6,627 | ||
Non-GAAP EBITDA | $ | (8,463 | ) |
Reconciling items impacting EBITDA: | |||
Non-cash share-based compensation expense | 3,317 | ||
Other income, net | (1,068 | ) | |
Inventory step-up amortization | 11,360 | ||
Transaction and transition costs | 11,100 | ||
Instrument use tax refund | — | ||
Non-GAAP adjusted EBITDA | $ | 16,246 | |
Wright Medical Group N.V.
Condensed Consolidated Balance Sheets
(dollars in thousands--unaudited)
March 27, 2016 | December 27, 2015 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 121,404 | $ | 139,804 | |||
Accounts receivable, net | 127,336 | 131,050 | |||||
Inventories | 215,577 | 229,109 | |||||
Prepaid expenses and other current assets | 63,573 | 59,921 | |||||
Total current assets | 527,890 | 559,884 | |||||
Property, plant and equipment, net | 236,790 | 240,769 | |||||
Goodwill and intangible assets, net | 1,137,315 | 1,133,087 | |||||
Other assets (1) | 77,476 | 139,754 | |||||
Total assets (1) | $ | 1,979,471 | $ | 2,073,494 | |||
Liabilities and shareholders' equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 30,789 | $ | 30,904 | |||
Accrued expenses and other current liabilities | 167,080 | 173,863 | |||||
Current portion of long-term obligations | 2,092 | 2,171 | |||||
Total current liabilities | 199,961 | 206,938 | |||||
Long-term obligations (1) | 570,434 | 561,201 | |||||
Other liabilities | 186,681 | 250,329 | |||||
Total liabilities (1) | 957,076 | 1,018,468 | |||||
Shareholders' equity | 1,022,395 | 1,055,026 | |||||
Total liabilities and shareholders' equity (1) | $ | 1,979,471 | $ | 2,073,494 | |||
(1) | The prior year debt issuance costs were reclassified to account for adoption of ASU 2015-03 and ASU 2015-15. |
11
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