e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2011
OR
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number 000-50744
NUVASIVE, INC.
(Exact name of registrant as specified in its charter)
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Delaware
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33-0768598 |
(State or other jurisdiction of
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(I.R.S. Employer |
incorporation or organization)
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Identification No.) |
7475 Lusk Boulevard
San Diego, CA 92121
(Address of principal executive offices, including zip code)
(858) 909-1800
(Registrants telephone number, including area code)
(Former name, former address and former fiscal year, if changed since last report)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.
Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate website, if any, every Interactive Data File required to be submitted and posted pursuant
to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the
registrant was required to submit and post such files).
Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the
Exchange Act. (Check one):
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Large accelerated filer þ
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Accelerated filer o
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Non-accelerated filer o
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Smaller reporting company o |
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(Do not check if a smaller reporting company) |
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No þ
As of
April 29, 2011, there were 39,673,718 shares of the registrants common stock outstanding.
NUVASIVE, INC.
QUARTERLY REPORT ON FORM 10-Q
March 31, 2011
TABLE OF CONTENTS
2
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
NUVASIVE, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except par value)
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March 31, |
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December 31, |
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2011 |
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2010 |
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(Unaudited) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
134,101 |
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$ |
92,597 |
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Short-term marketable securities |
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58,876 |
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86,458 |
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Accounts receivable, net |
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75,952 |
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76,632 |
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Inventory |
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114,388 |
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107,577 |
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Deferred tax assets |
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4,425 |
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4,425 |
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Prepaid expenses and other current assets |
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4,750 |
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4,082 |
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Total current assets |
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392,492 |
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371,771 |
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Property and equipment, net |
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105,066 |
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102,165 |
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Long-term marketable securities |
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32,814 |
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50,635 |
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Intangible assets, net |
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105,817 |
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107,121 |
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Goodwill |
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103,070 |
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103,070 |
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Deferred tax assets, non-current |
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52,033 |
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52,033 |
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Other assets |
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15,438 |
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15,234 |
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Total assets |
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$ |
806,730 |
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$ |
802,029 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable and accrued liabilities |
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$ |
54,899 |
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$ |
58,995 |
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Accrued payroll and related expenses |
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14,643 |
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17,266 |
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Acquisition-related liabilities |
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33,155 |
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32,715 |
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Total current liabilities |
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102,697 |
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108,976 |
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Senior convertible notes |
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230,000 |
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230,000 |
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Long-term acquisition-related liabilities |
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339 |
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326 |
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Deferred tax liabilities |
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3,685 |
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3,685 |
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Other long-term liabilities |
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12,729 |
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12,810 |
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Commitments and contingencies
Noncontrolling interests |
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11,496 |
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11,877 |
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Stockholders equity: |
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Preferred stock, $0.001 par value; 5,000 shares authorized, none outstanding |
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Common stock, $0.001 par value; 70,000 shares authorized, 39,652 and 39,528
issued and outstanding at March 31, 2011 and December 31, 2010,
respectively |
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40 |
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40 |
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Additional paid-in capital |
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553,484 |
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545,114 |
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Accumulated other comprehensive income |
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1,316 |
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616 |
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Accumulated deficit |
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(109,056 |
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(111,415 |
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Total stockholders equity |
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445,784 |
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434,355 |
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Total liabilities and stockholders equity |
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$ |
806,730 |
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$ |
802,029 |
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See accompanying notes to unaudited condensed consolidated financial statements.
3
NUVASIVE, INC.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(in thousands, except per share data)
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Three Months Ended |
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March 31, |
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2011 |
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2010 |
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Revenue |
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$ |
124,466 |
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$ |
109,087 |
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Cost of goods sold (excluding amortization of purchased technology) |
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23,526 |
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19,443 |
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Gross profit |
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100,940 |
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89,644 |
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Operating expenses: |
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Sales, marketing and administrative |
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84,220 |
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74,661 |
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Research and development |
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10,769 |
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10,699 |
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Amortization of intangible assets |
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1,342 |
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1,350 |
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Total operating expenses |
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96,331 |
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86,710 |
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Interest income |
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183 |
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189 |
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Interest expense |
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(1,771 |
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(1,669 |
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Other income, net |
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497 |
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117 |
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Total interest and other expense, net |
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(1,091 |
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(1,363 |
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Income before income tax expense |
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3,518 |
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1,571 |
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Income tax expense |
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1,540 |
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865 |
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Consolidated net income |
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$ |
1,978 |
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$ |
706 |
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Net loss attributable to noncontrolling interests |
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$ |
(381 |
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$ |
(382 |
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Net income attributable to NuVasive, Inc. |
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$ |
2,359 |
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$ |
1,088 |
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Net income per share attributable to NuVasive, Inc.: |
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Basic and diluted |
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$ |
0.06 |
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$ |
0.03 |
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Weighted average shares outstanding: |
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Basic |
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39,616 |
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38,898 |
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Diluted |
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40,511 |
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40,061 |
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See accompanying notes to unaudited condensed consolidated financial statements.
4
NUVASIVE, INC.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
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Three Months Ended |
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March 31, |
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2011 |
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2010 |
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Operating activities: |
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Consolidated net income |
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$ |
1,978 |
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$ |
706 |
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Adjustments to reconcile net income to net cash provided by operating activities: |
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Depreciation and amortization |
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7,781 |
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8,104 |
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Stock-based compensation |
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7,946 |
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6,434 |
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Allowance for excess and obsolete inventory |
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216 |
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736 |
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Allowance for doubtful accounts and sales return reserves, net of write-offs |
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6 |
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(657 |
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Other non-cash adjustments |
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1,795 |
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1,454 |
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Changes in operating assets and liabilities, net of effects from acquisitions: |
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Accounts receivable |
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942 |
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(3,100 |
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Inventory |
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(6,658 |
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(1,237 |
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Prepaid expenses and other current assets |
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(751 |
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(1,570 |
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Accounts payable and accrued liabilities |
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3,959 |
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4,780 |
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Accrued payroll and related expenses |
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(2,670 |
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(6,512 |
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Net cash provided by operating activities |
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14,544 |
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9,138 |
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Investing activities: |
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Purchases of property and equipment |
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(10,000 |
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(8,402 |
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Purchases of marketable securities |
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(26,018 |
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(45,525 |
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Sales of marketable securities |
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71,185 |
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54,016 |
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Payment for specific rights in connection with supply agreement |
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(8,000 |
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Net cash provided by investing activities |
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27,167 |
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89 |
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Financing activities: |
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Issuance of common stock |
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425 |
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6,628 |
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Other assets |
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(709 |
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(4,408 |
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Tax benefits related to stock-based compensation awards |
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882 |
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Net cash (used in) provided by financing activities |
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(284 |
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3,102 |
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Effect of exchange rate changes on cash |
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77 |
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(78 |
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Increase in cash and cash equivalents |
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41,504 |
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12,251 |
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Cash and cash equivalents at beginning of period |
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92,597 |
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65,413 |
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Cash and cash equivalents at end of period |
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$ |
134,101 |
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$ |
77,664 |
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See accompanying notes to unaudited condensed consolidated financial statements.
5
NuVasive, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements
1. Description of Business and Basis of Presentation
Description of Business
NuVasive®, Inc. (the Company or NuVasive) was incorporated in Delaware on July 21,
1997. The Company is focused on developing minimally disruptive surgical products and procedures
for the spine. The Company began commercializing its products in 2001. Its currently-marketed
product portfolio is focused on applications for spine fusion surgery. Its principal product
offering includes a minimally disruptive surgical platform called Maximum Access Surgery, or
MAS®, as well as a growing offering of biologics, cervical and motion preservation
products. In the spine surgery market, the Companys currently-marketed products are primarily used
to enable access to the spine and to perform restorative and fusion procedures in a minimally
disruptive fashion. The Company also focuses significant research and development efforts on
expanding its MAS product platform, advancing the applications of their unique technology to
additional procedures, and developing motion preservation products. The Company dedicates
significant resources toward training spine surgeons on its unique technology and products.
The Companys primary business model is to loan its MAS systems to surgeons and hospitals who
purchase disposables and implants for use in individual procedures. In addition, for larger
customers, the Companys proprietary nerve monitoring systems, MaXcess® and surgical
instrument sets are placed with hospitals for an extended period at no up-front cost to them. The
Company also offers a range of bone allograft in patented saline packaging, disposables and spine
implants, which include its branded CoRoent® products and fixation devices such as rods,
plates and screws. Implants and disposables are shipped from the Companys inventories. The Company
sells an immaterial quantity of MAS instrument sets, MaXcess and nerve monitoring systems to
hospitals.
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared
pursuant to the rules and regulations of the Securities and Exchange Commission (SEC). Pursuant to
these rules and regulations, the Company has condensed or omitted certain information and footnote
disclosures it normally includes in its annual consolidated financial statements prepared in
accordance with accounting principles generally accepted in the United States (GAAP). In the
opinion of management, the consolidated financial statements include all adjustments necessary,
which are of a normal and recurring nature, for the fair presentation of the Companys financial
position and of the results of operations and cash flows for the periods presented.
The accompanying unaudited condensed consolidated financial statements as of December 31, 2010
and for the three months ended March 31, 2011 and 2010 include the accounts of the Company and its
wholly owned subsidiaries, as well as the accounts of a variable interest entity, Progentix
Orthobiology, B.V. (Progentix), which is consolidated pursuant to existing guidance issued by the
Financial Accounting Standards Board (FASB). All significant intercompany accounts and transactions
have been eliminated in consolidation.
These financial statements should be read in conjunction with the audited consolidated
financial statements and notes thereto for the year ended December 31, 2010 included in NuVasives
Annual Report on Form 10-K filed with the SEC. Operating results for the three months ended March
31, 2011 are not necessarily indicative of the results that may be expected for any other interim
period or for the full year. The balance sheet at December 31, 2010 has been derived from the
audited financial statements at that date, but does not include all of the information and
footnotes required by GAAP for complete financial statements.
Change in Accounting Estimate
During the first quarter of 2011, the Company completed a review of the estimated useful life
of its surgical instrument sets. Based on historical useful life information, as well as
forecasted product life cycles and demand expectations, the useful life of certain surgical
instrument sets was extended from three to four years. In accordance with authoritative guidance,
this was accounted for as a change in accounting estimate and was made on a prospective basis
effective January 1, 2011. For the three months ended March 31, 2011, depreciation expense, which
is included in sales, marketing and administrative expenses, was approximately $1.7 million less
than it would have been had the useful life of these assets not been extended. The effect of this
change on basic and diluted earnings per share for the three months ended March 31, 2011 was $0.02
per share.
6
2. Significant Accounting Policies
Recently Adopted Accounting Standards
Fair Value Measurements Disclosures
Effective January 1, 2011, the Company adopted the FASBs updated guidance related to fair
value measurements and disclosures, which requires a reporting entity to disclose separately
information related to purchases, sales, issuances, and settlements in the reconciliation for fair
value measurements using significant unobservable inputs, or Level 3, to be included in the
rollforward of activity. The guidance is effective for interim or annual financial reporting
periods beginning after December 15, 2010. The Company has updated its disclosures to comply with
the updated guidance; however, adoption of the updated guidance did not have an impact on the
Companys consolidated results of operations or financial position.
3. Investment in Progentix Orthobiology, B.V.
In 2009, the Company completed the purchase of forty percent (40%) of the capital stock of
Progentix, a company organized under the laws of the Netherlands, from existing shareholders (the
Progentix Shareholders) pursuant to a Preferred Stock Purchase Agreement for $10 million in cash
(the Initial Investment). Concurrent with the Initial Investment, NuVasive and Progentix also
entered into a Senior Secured Facility Agreement, whereby Progentix may borrow up to $5 million
from NuVasive to fund ongoing clinical and regulatory efforts (the Loan). At March 31, 2011, the
Company had advanced Progentix the full $5.0 million in accordance with the Loan Agreement. The
Loan accrues interest at a rate of six percent (6%) per year. Other than its obligations under the
Loan Agreement, NuVasive is not obligated to provide additional funding, nor has any additional
funding been provided, to Progentix.
Also concurrent with the Preferred Stock Purchase Agreement, NuVasive, Progentix and the
Progentix Shareholders entered into an Option Purchase Agreement, as amended (the Option
Agreement), whereby NuVasive may be obligated (the Put Option), upon the achievement of certain
milestones by Progentix by June 13, 2011, to purchase the remaining sixty percent (60%) of capital
stock of Progentix from its shareholders (the Remaining Shares) for an amount up to $45.0 million,
payable in a combination of cash or NuVasive common stock, at NuVasives sole discretion, subject
to certain adjustments (at April 1, 2011, the aggregate amount of additional payments NuVasive may
be obligated to pay for the Remaining Shares is $44.0 million).
NuVasive may also be obligated, in the event that Progentix achieves the milestones specified
in the agreements and completes additional milestones and NuVasive achieves specified sales
targets, by June 13, 2011, to make additional payments to the Progentix Shareholders, excluding
NuVasive, of up to an aggregate total of $25.0 million, payable in a combination of cash and
NuVasive common stock, at NuVasives sole discretion, subject to certain adjustments (at April 1,
2011, the aggregate amount of additional payments NuVasive may be obligated to pay related to these
milestones is $20.0 million). NuVasive also has the right under the Option Agreement to purchase
the Remaining Shares (the Call Option) during June 14, 2011 through June 13, 2013 (the Option
Period) for an amount up to $35.0 million, payable in a combination of cash and NuVasive common
stock, at the Companys sole discretion, subject to certain adjustments. In the event NuVasive
achieves in excess of a specified annual sales run rate on Progentix products during the Option
Period, NuVasive may be required to purchase the Remaining Shares for an amount up to $35.0
million. NuVasive and Progentix also entered into a Distribution Agreement, as amended, whereby
Progentix appointed NuVasive as its exclusive distributor for certain Progentix products. The
Distribution Agreement will be in effect for a term of ten years unless terminated earlier in
accordance with its terms.
In accordance with authoritative guidance issued by the FASB, the Company has determined that
Progentix is a variable interest entity (VIE) as it does not have the ability to finance its
activities without additional subordinated financial support and its equity investors will not
absorb their proportionate share of expected losses and will be limited in the receipt of the
potential residual returns of Progentix. Additionally, pursuant to this guidance, NuVasive is
considered its primary beneficiary as NuVasive has both (1) the power to direct the economically
significant activities of Progentix and (2) the obligation to absorb losses of, or the right to
receive benefits from, Progentix. Accordingly, the financial position and results of operations of
Progentix have been included in the consolidated financial statements from the date of the Initial
Investment. The liabilities recognized as a result of consolidating Progentix do not represent
additional claims on the Companys general assets. The creditors of Progentix have claims only on
the assets of Progentix, which are not material, and the assets of Progentix are not available to
NuVasive.
Pursuant to authoritative guidance, the equity interests in Progentix not owned by the
Company, which includes shares of both common and preferred stock, are reported as noncontrolling
interests on the consolidated balance sheet of the Company. The preferred stock represents 18% of
the noncontrolling equity interests and provides for a cumulative 8% dividend, if and when declared
by
7
Progentixs Board of Directors. As the rights and conversion features of the preferred stock
are substantially the same as those of the common stock, the preferred stock is classified as
noncontrolling interest and shares in the allocation of the losses incurred by Progentix. Losses
incurred by Progentix are charged to the Company and to the noncontrolling interest holders based
on their ownership percentage. The Remaining Shares and the Option Agreement that was entered into
between NuVasive, Progentix and the Progentix Shareholders are not considered to be freestanding
financial instruments as defined by authoritative guidance. Therefore the Remaining Shares and the
Option Agreement are accounted for as a combined unit on the consolidated financial statements as a
redeemable noncontrolling interest that was initially recorded at fair value and classified as
mezzanine equity.
Pursuant to authoritative guidance, when the embedded Put Option is exercisable and therefore
the Remaining Shares considered currently redeemable (i.e., at the option of the holder), the
instrument will be adjusted to its maximum redemption amount. If the embedded Put Option is
considered not currently exercisable (e.g., because a contingency has not been met), and it is not
probable that the embedded Put Option will become exercisable, an adjustment is not necessary until
it is probable that the embedded Put Option will become exercisable. At March 31, 2011, the
embedded Put Option was not deemed currently exercisable and therefore the Remaining Shares were
not redeemable because the milestones referred to previously had not been met. Furthermore, at
March 31, 2011, the Company concluded it is not probable that the milestones will be met, therefore
the Remaining Shares are not expected to become redeemable. The probability of redemption is
reevaluated at each reporting period.
Total assets and liabilities of Progentix as of March 31, 2011 included in the accompanying
condensed consolidated balance sheet are as follows (in thousands):
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Total current assets |
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$ |
470 |
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Identifiable intangible assets, net |
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15,683 |
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Goodwill |
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12,654 |
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Other long-term assets |
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427 |
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Accounts payable & accrued expenses |
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318 |
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Other long-term liabilities |
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403 |
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Deferred tax liabilities, net |
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3,685 |
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Noncontrolling interests |
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11,496 |
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|
The following is a reconciliation of equity (net assets) attributable to the noncontrolling
interests (in thousands): |
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Noncontrolling interests at December 31, 2010 |
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$ |
11,877 |
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Less: Net loss attributable to the noncontrolling interests |
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381 |
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Noncontrolling interests at March 31, 2011 |
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$ |
11,496 |
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|
4. Balance Sheet Reserves
The balances of the reserves for accounts receivable and inventory are as follows (in
thousands):
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March 31, |
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December 31, |
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2011 |
|
2010 |
Reserves for accounts receivable and sales returns |
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$ |
2,390 |
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$ |
2,573 |
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Reserves for excess and obsolete inventory |
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6,898 |
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6,682 |
|
The Companys inventory consists primarily of purchased finished goods, which includes
specialized implants and disposables, and is stated at the lower of cost or market determined by a
weighted average cost method. The Company reviews the components of its inventory on a periodic
basis for excess, obsolete or impaired inventory, and records a reserve for the identified items.
8
5. Marketable Securities and Fair Value Measurements
Marketable securities consist of corporate debt securities, U.S. government treasury
securities and securities of government sponsored entities. The Company classifies all securities
as available-for-sale, as the sale of such securities may be required prior to maturity to
implement management strategies. These securities are carried at fair value, with the unrealized
gains and losses reported as a component of other comprehensive
income in stockholders equity
until realized. A decline in the market value of any marketable security below cost that is
determined to be other than temporary will result in a revaluation of its carrying amount to fair
value. The impairment is charged to earnings and a new cost basis for the security is established.
No such impairment charges were recorded for any period presented.
Realized gains and losses from the sale of marketable securities, if any, are determined on a
specific identification basis. Realized gains and losses and declines in value judged to be
other-than-temporary, if any, on available-for-sale securities are included in other income or
expense on the consolidated statements of income. Realized gains and losses during the periods
presented were immaterial. Premiums and discounts are amortized or accreted over the life of the
related security as an adjustment to yield using the straight-line method and are included in
interest income on the consolidated statements of income. Interest and dividends on securities
classified as available-for-sale are included in interest income on the consolidated statements of
income.
The
composition of marketable securities is as follows (in thousands,
except years):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contractual |
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
|
|
|
|
Maturity |
|
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
|
|
|
|
(in Years) |
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Fair Value |
|
March 31, 2011: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Classified as current assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Certificates of deposit |
|
Less than 1 |
|
$ |
910 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
910 |
|
Corporate notes |
|
Less than 1 |
|
|
10,093 |
|
|
|
4 |
|
|
|
|
|
|
|
10,097 |
|
U.S. government treasury securities |
|
Less than 1 |
|
|
14,550 |
|
|
|
10 |
|
|
|
|
|
|
|
14,560 |
|
Securities of government-sponsored entities |
|
Less than 1 |
|
|
33,295 |
|
|
|
15 |
|
|
|
(1 |
) |
|
|
33,309 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term marketable securities |
|
|
|
|
|
|
58,848 |
|
|
|
29 |
|
|
|
(1 |
) |
|
|
58,876 |
|
Classified as non-current assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Certificates of deposit |
|
|
1 to 2 |
|
|
|
194 |
|
|
|
|
|
|
|
|
|
|
|
194 |
|
Corporate notes |
|
|
1 to 2 |
|
|
|
6,157 |
|
|
|
|
|
|
|
(3 |
) |
|
|
6,154 |
|
Securities of government-sponsored entities |
|
|
1 to 2 |
|
|
|
26,502 |
|
|
|
1 |
|
|
|
(37 |
) |
|
|
26,466 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term marketable securities |
|
|
|
|
|
|
32,853 |
|
|
|
1 |
|
|
|
(40 |
) |
|
|
32,814 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total marketable securities at March 31, 2011 |
|
|
|
|
|
$ |
91,701 |
|
|
$ |
30 |
|
|
$ |
(41 |
) |
|
$ |
91,690 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contractual |
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
|
|
|
|
Maturity |
|
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
|
|
|
|
(in Years) |
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Fair Value |
|
December 31, 2010: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Classified as current assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Certificates of deposit |
|
Less than 1 |
|
$ |
938 |
|
|
$ |
1 |
|
|
$ |
(1 |
) |
|
$ |
938 |
|
Corporate notes |
|
Less than 1 |
|
|
12,076 |
|
|
|
3 |
|
|
|
|
|
|
|
12,079 |
|
U.S. government treasury securities |
|
Less than 1 |
|
|
16,550 |
|
|
|
12 |
|
|
|
(1 |
) |
|
|
16,561 |
|
Securities of government-sponsored entities |
|
Less than 1 |
|
|
56,870 |
|
|
|
24 |
|
|
|
(14 |
) |
|
|
56,880 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term marketable securities |
|
|
|
|
|
|
86,434 |
|
|
|
40 |
|
|
|
(16 |
) |
|
|
86,458 |
|
Classified as non-current assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Certificates of deposit |
|
|
1 to 2 |
|
|
|
456 |
|
|
|
|
|
|
|
|
|
|
|
456 |
|
Corporate notes |
|
|
1 to 2 |
|
|
|
3,123 |
|
|
|
|
|
|
|
(9 |
) |
|
|
3,114 |
|
U.S. government treasury securities |
|
|
1 to 2 |
|
|
|
4,023 |
|
|
|
|
|
|
|
|
|
|
|
4,023 |
|
Securities of government-sponsored entities |
|
|
1 to 2 |
|
|
|
43,056 |
|
|
|
6 |
|
|
|
(20 |
) |
|
|
43,042 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term marketable securities |
|
|
|
|
|
|
50,658 |
|
|
|
6 |
|
|
|
(29 |
) |
|
|
50,635 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total marketable securities at December 31, 2010 |
|
|
|
|
|
$ |
137,092 |
|
|
$ |
46 |
|
|
$ |
(45 |
) |
|
$ |
137,093 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of March 31, 2011, the Company had no significant investment positions that were in an
unrealized loss position. The Company reviews its investments to identify and evaluate investments
that have an indication of possible other-than-temporary impairment. Factors considered in
determining whether a loss is other-than-temporary include the length of time and extent to which
fair value has been less than the cost basis, the financial condition and near-term prospects of
the investee, and the Companys intent
9
and ability to hold the investment for a period of time sufficient to allow for any
anticipated recovery in market value. The Company maintains an investment portfolio of various
holdings, types and maturities. The Company does not use derivative financial instruments. The
Company places its cash investments in instruments that meet high credit quality standards, as
specified in its investment policy guidelines. These guidelines also limit the amount of credit
exposure to any one issue, issuer or type of instrument.
The Company measures certain assets and liabilities in accordance with authoritative guidance
which requires fair value measurements be classified and disclosed in one of the following three
categories:
Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date
for assets or liabilities.
Level 2: Observable prices that are based on inputs not quoted on active markets, but corroborated
by market data.
Level 3: Unobservable inputs are used when little or no market data is available.
Assets and liabilities are classified based on the lowest level of input that is significant
to the fair value measurements. The Company reviews the fair value hierarchy classification on a
quarterly basis. Changes in the ability to observe valuation inputs may result in a
reclassification of levels for certain securities within the fair value hierarchy. The Company did
not have any transfers of assets and liabilities between Level 1 and Level 2 and no transfers to or
from Level 3 of the fair value measurement hierarchy during the three months ended March 31, 2011.
The fair values of the Companys assets and liabilities at March 31, 2011, which are measured
at fair value on a recurring basis, were determined using the following inputs (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quoted Price in |
|
|
Significant Other |
|
|
Significant |
|
|
|
|
|
|
|
Active Market |
|
|
Observable Inputs |
|
|
Unobservable |
|
|
|
Total |
|
|
(Level 1) |
|
|
(Level 2) |
|
|
Inputs (Level 3) |
|
Marketable Securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Certificates of deposit |
|
$ |
1,104 |
|
|
$ |
1,104 |
|
|
$ |
|
|
|
$ |
|
|
Corporate notes |
|
|
16,251 |
|
|
|
14,251 |
|
|
|
2,000 |
|
|
|
|
|
U.S government treasury securities |
|
|
14,560 |
|
|
|
14,560 |
|
|
|
|
|
|
|
|
|
Securities of government-sponsored entities |
|
|
59,775 |
|
|
|
59,775 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total marketable securities at March 31, 2011 |
|
$ |
91,690 |
|
|
$ |
89,690 |
|
|
$ |
2,000 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent Consideration: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquisition-related liabilities |
|
$ |
(33,494 |
) |
|
$ |
|
|
|
$ |
|
|
|
$ |
(33,494 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
The fair and carrying value of the Companys Senior Convertible Notes is discussed in Note 7.
Contingent Consideration Liability
In connection with the acquisition of Cervitech®, Inc. (Cervitech) in May 2009, the Company is
required to pay an additional amount not to exceed $33.0 million in the event that the PCM®
cervical total disc replacement device receives U.S. Food and Drug Administration approval.
The fair value of the contingent consideration is determined using a probability-weighted
discounted cash flow model, the significant inputs which are not observable in the market. The key
assumptions in applying this approach are the interest rate, the timing of expected approval and
the probability assigned to the milestone being achieved. Based on the expected timing of the
milestone being achieved, the estimated fair value of the contingent consideration increased to
$32.1 million at March 31, 2011. Changes in fair value are recorded in the statement of income as
sales, marketing and administrative expenses.
In connection with an immaterial acquisition in 2010, the Company is required to pay an
additional amount not to exceed $3.0 million in the event three specified milestones are met. The
fair value of the contingent consideration is determined using a probability-weighted discounted
cash flow model, the significant inputs which are not observable in the market. The key assumptions
in applying this approach are the interest rate and the probabilities assigned to the milestones
being achieved. Based on the probabilities assigned to the milestones being achieved, the estimated
fair value of the contingent consideration totaled $1.4 million at March 31, 2011. Changes in fair
value are recorded in the statement of income as sales, marketing and administrative expenses.
10
The following table sets forth the change in the estimated fair value for the Companys
liabilities measured using significant unobservable inputs (Level 3) (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
|
|
2011 |
|
2010 |
Fair value measurement at beginning of period |
|
$ |
33,041 |
|
|
$ |
30,694 |
|
Change in fair value measurement included in operating expenses |
|
|
453 |
|
|
|
|
|
|
|
|
|
|
|
|
Fair value measurement at end of period |
|
$ |
33,494 |
|
|
$ |
30,694 |
|
|
|
|
|
|
|
|
6. Goodwill and Intangible Assets
Goodwill and intangible assets as of March 31, 2011 consisted of the following (in thousands,
except years):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
|
|
|
|
Amortization |
|
Gross |
|
|
|
|
|
|
|
|
|
Period |
|
Carrying |
|
|
Accumulated |
|
|
Intangible |
|
|
|
(in years) |
|
Amount |
|
|
Amortization |
|
|
Assets, net |
|
|
|
|
|
|
|
|
|
|
|
Intangible Assets Subject to Amortization: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchased technology: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Developed technology |
|
14 |
|
$ |
39,975 |
|
|
$ |
(8,546 |
) |
|
$ |
31,429 |
|
Manufacturing know-how and trade secrets |
|
12 |
|
|
21,146 |
|
|
|
(4,659 |
) |
|
|
16,487 |
|
Trade name and trademarks |
|
14 |
|
|
6,100 |
|
|
|
(1,067 |
) |
|
|
5,033 |
|
Customer relationships |
|
13 |
|
|
10,035 |
|
|
|
(3,167 |
) |
|
|
6,868 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14 |
|
$ |
77,256 |
|
|
$ |
(17,439 |
) |
|
$ |
59,817 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible Assets Not Subject to Amortization: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In-process research and development |
|
|
|
|
|
|
|
|
|
|
|
|
46,000 |
|
Goodwill |
|
|
|
|
|
|
|
|
|
|
|
|
103,070 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total intangible assets, net |
|
|
|
|
|
|
|
|
|
|
|
$ |
208,887 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Goodwill and intangible assets as of December 31, 2010 consisted of the following (in
thousands, except years):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
|
|
|
|
Amortization |
|
Gross |
|
|
|
|
|
|
|
|
|
Period |
|
Carrying |
|
|
Accumulated |
|
|
Intangible |
|
|
|
(in years) |
|
Amount |
|
|
Amortization |
|
|
Assets, net |
|
Intangible Assets Subject to Amortization: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchased technology: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Developed technology |
|
14 |
|
$ |
39,975 |
|
|
$ |
(7,946 |
) |
|
$ |
32,029 |
|
Manufacturing know-how and trade secrets |
|
12 |
|
|
21,104 |
|
|
|
(4,207 |
) |
|
|
16,897 |
|
Trade name and trademarks |
|
14 |
|
|
6,100 |
|
|
|
(956 |
) |
|
|
5,144 |
|
Customer relationships |
|
13 |
|
|
10,035 |
|
|
|
(2,984 |
) |
|
|
7,051 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14 |
|
$ |
77,214 |
|
|
$ |
(16,093 |
) |
|
$ |
61,121 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible Assets Not Subject to Amortization: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In-process research and development |
|
|
|
|
|
|
|
|
|
|
|
|
46,000 |
|
Goodwill |
|
|
|
|
|
|
|
|
|
|
|
|
103,070 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total intangible assets, net |
|
|
|
|
|
|
|
|
|
|
|
$ |
210,191 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total expense related to the amortization of intangible assets was $1.3 million and $1.4
million for the three months ended March 31, 2011 and 2010, respectively. In-process research and
development will be amortized beginning on the approval date of the respective acquired products
and will be amortized over the estimated useful life determined at that time.
11
Total future amortization expense related to intangible assets subject to amortization at
March 31, 2011 is set forth in the table below (in thousands):
|
|
|
|
|
Remaining 2011 |
|
$ |
4,441 |
|
2012 |
|
|
5,912 |
|
2013 |
|
|
5,894 |
|
2014 |
|
|
5,858 |
|
2015 |
|
|
5,537 |
|
2015 |
|
|
5,338 |
|
Thereafter through 2027 |
|
|
26,837 |
|
|
|
|
|
Total future amortization expense |
|
$ |
59,817 |
|
|
|
|
|
7. Senior Convertible Notes
In March 2008, the Company issued $230.0 million principal amount of 2.25% unsecured Senior
Convertible Notes (the Notes), which includes the subsequent exercise of the initial purchasers
option to purchase an additional $30.0 million aggregate principal amount of the Notes. The net
proceeds from the offering, after deducting the initial purchasers discount and costs directly
related to the offering, were approximately $208.4 million. The Company pays 2.25% interest per
annum on the principal amount of the Notes, payable semi-annually in arrears in cash on March 15
and September 15 of each year. Any notes not converted prior to March 15, 2013, the Maturity Date,
will be paid in cash. The fair value, based on quoted market prices, of the outstanding notes at
March 31, 2011 is approximately $226.8 million.
The Notes are convertible into shares of the Companys common stock, based on an initial
conversion rate, subject to adjustment, of 22.3515 shares per $1,000 principal amount of the Notes
(which represents an initial conversion price of approximately $44.74 per share). Holders may
convert their notes at their option on any day up to and including the second scheduled trading day
immediately preceding the Maturity Date. If a fundamental change to the Companys business occurs,
as defined in the Notes, holders of the Notes have the right to require that the Company repurchase
the Notes, or a portion thereof, at the principal amount plus accrued and unpaid interest.
In connection with the offering of the Notes, the Company entered into convertible note hedge
transactions (the Hedge) with the initial purchasers and/or their affiliates (the Counterparties)
entitling the Company to purchase up to 5.1 million shares of the Companys common stock at an
initial stock price of $44.74 per share, each of which is subject to adjustment. In addition, the
Company sold to the Counterparties warrants to acquire up to 5.1 million shares of the Companys
common stock (the Warrants), at an initial strike price of $49.13 per share, subject to adjustment.
The cost of the Hedge that was not covered by the proceeds from the sale of the Warrants was
approximately $14.0 million and was recorded as a reduction of additional paid-in capital as of
December 31, 2008. The impact of the Hedge is to raise the effective conversion price of the Notes
to approximately $49.13 per share (or approximately 20.3542 shares per $1,000 principal amount of
the Notes). The Hedge is expected to reduce the potential equity dilution upon conversion of the
Notes if the daily volume-weighted average price per share of the Companys common stock exceeds
the strike price of the Hedge. The Warrants could have a dilutive effect on the Companys earnings
per share to the extent that the price of the Companys common stock during a given measurement
period (the quarter or year to date period) exceeds the strike price of the Warrants.
8. Net Income Per Share
The Company computes basic net income per share using the weighted-average number of common
shares outstanding during the period. Diluted net income assumes the conversion, exercise or
issuance of all potential common stock equivalents, unless the effect of inclusion would be
anti-dilutive. For purposes of this calculation, common stock equivalents include the Companys
stock options, unvested restricted stock units, warrants and the shares to be issued upon the
conversion of the Senior Convertible Notes. No shares related to the assumed conversion of the
Senior Convertible Notes were included in the diluted net income calculation for the three months
ended March 31, 2011 and 2010 because the inclusion of such shares would have had an anti-dilutive
effect. The shares to be issued upon exercise of all outstanding warrants were excluded from the
diluted net income calculation for the three months ended March 31, 2011 and 2010 because the
inclusion of such shares would have had an anti-dilutive effect.
12
The following table sets forth the computation of basic and diluted earnings per share (in
thousands, except share and per share data):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
|
|
2011 |
|
2010 |
Numerator: |
|
|
|
|
|
|
|
|
Net income attributable to NuVasive, Inc. |
|
$ |
2,359 |
|
|
$ |
1,088 |
|
|
|
|
|
|
|
|
Denominator for basic and diluted net income per share: |
|
|
|
|
|
|
|
|
Weighted average common shares outstanding for basic |
|
|
39,616 |
|
|
|
38,898 |
|
Dilutive potential common stock outstanding: |
|
|
|
|
|
|
|
|
Stock options |
|
|
636 |
|
|
|
1,050 |
|
Restricted stock units |
|
|
259 |
|
|
|
113 |
|
|
|
|
|
|
|
|
Weighted average common shares outstanding for diluted |
|
|
40,511 |
|
|
|
40,061 |
|
|
|
|
|
|
|
|
Basic and diluted net income per share attributable to NuVasive, Inc. |
|
$ |
0.06 |
|
|
$ |
0.03 |
|
|
|
|
|
|
|
|
The following outstanding common stock equivalents were not included in the calculation of net
income per diluted share because their effects were anti-dilutive (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
|
|
2011 |
|
2010 |
|
|
|
Weighted stock options and RSUs |
|
|
5,072 |
|
|
|
3,117 |
|
Warrants |
|
|
5,141 |
|
|
|
5,141 |
|
Senior convertible notes |
|
|
5,141 |
|
|
|
5,141 |
|
|
|
|
|
|
|
|
Total |
|
|
15,354 |
|
|
|
13,399 |
|
|
|
|
|
|
|
|
9. Comprehensive Income
The components of comprehensive income are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
|
|
2011 |
|
2010 |
|
|
|
|
|
Consolidated net income |
|
$ |
1,978 |
|
|
$ |
706 |
|
Other comprehensive income: |
|
|
|
|
|
|
|
|
Unrealized loss on investments |
|
|
(11 |
) |
|
|
(13 |
) |
Translation adjustments |
|
|
711 |
|
|
|
(406 |
) |
|
|
|
|
|
|
|
Total consolidated comprehensive income |
|
|
2,678 |
|
|
|
287 |
|
Plus: Net loss attributable to noncontrolling interests |
|
|
381 |
|
|
|
382 |
|
|
|
|
|
|
|
|
Comprehensive income attributable to NuVasive, Inc. |
|
$ |
3,059 |
|
|
$ |
669 |
|
|
|
|
|
|
|
|
10. Stock-Based Compensation
The Company estimates the fair value of stock options and shares issued to employees under the
Employee Stock Purchase Plan, or ESPP Plan, using a Black-Scholes option-pricing model on the date
of grant. The fair value of RSUs is based on the stock price on the date of grant. The fair value
of equity instruments that are expected to vest are recognized and amortized on an accelerated
basis over the requisite service period.
13
The weighted-average assumptions used to estimate the fair value of stock options granted and
stock purchase rights under the Employee Stock Purchase Plan (ESPP) are as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
|
|
2011 |
|
2010 |
|
|
|
Stock Options |
|
|
|
|
|
|
|
|
Volatility |
|
|
49 |
% |
|
|
47 |
% |
Expected term (years) |
|
|
5.4 |
|
|
|
4.5 |
|
Risk free interest rate |
|
|
2.2 |
% |
|
|
2.4 |
% |
Expected dividend yield |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
ESPP |
|
|
|
|
|
|
|
|
Volatility |
|
|
59 |
% |
|
|
50 |
% |
Expected term (years) |
|
|
1.0 |
|
|
|
1.3 |
|
Risk free interest rate |
|
|
0.2 |
% |
|
|
1.0 |
% |
Expected dividend yield |
|
|
0.0 |
% |
|
|
0.0 |
% |
The compensation cost that has been included in the consolidated statement of income for all
stock-based compensation arrangements was as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
|
|
2011 |
|
2010 |
|
|
|
Sales, marketing and administrative expense |
|
$ |
7,335 |
|
|
$ |
5,680 |
|
Research and development expense |
|
|
611 |
|
|
|
754 |
|
|
|
|
|
|
|
|
Total stock-based compensation expense |
|
$ |
7,946 |
|
|
$ |
6,434 |
|
|
|
|
|
|
|
|
11. Income Taxes
The Company recorded income tax expense of $1.5 million and $0.9 million for the three months
ended March 31, 2011 and 2010, respectively. The effective income tax rate for the three months
ended March 31, 2011 was 44%, which is based on an estimate of the Companys annual effective
income tax rate. The Company updates its annual effective income tax rate each quarter and if the
estimated effective income tax rate changes, a cumulative adjustment is made. The annual effective
income tax rate for 2011 is expected to be higher than the U.S. federal statutory rate of 35%
primarily due to state income taxes, net of federal benefit, estimates for certain non-deductible
expenses, and foreign losses expected to be incurred for which no benefit can be recorded.
There was no material change to the Companys unrecognized tax benefits and interest accrued
related to unrecognized tax benefits during the three months ended March 31, 2011.
12. Business Segment and Product Information
The Companys business operates in one segment based upon the Companys organizational
structure, the way in which the operations are managed and evaluated and the lack of availability
of separate financial results. Substantially all of the Companys assets and sales are in the
United States.
The Companys spine surgery product line offerings, which include thoracolumbar product
offerings, cervical offerings, and a set of motion preservation products still under development,
are primarily used to enable access to the spine and to perform restorative and fusion procedures
in a minimally disruptive fashion. The Companys biologic product line offerings include allograft
(donated human tissue), FormaGraft®, a collagen synthetic product used to aid the fusion
process, and Osteocel® Plustm, an allograft cellular matrix
containing viable mesenchymal stem cells, or MSCs, to aid in spinal fusion. Revenue by product line
offerings was as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
|
|
2011 |
|
2010 |
|
|
|
Spine Surgery Products |
|
$ |
101,908 |
|
|
$ |
89,151 |
|
Biologics |
|
|
22,558 |
|
|
|
19,936 |
|
|
|
|
|
|
|
|
Total Revenue |
|
$ |
124,466 |
|
|
$ |
109,087 |
|
|
|
|
|
|
|
|
14
13. Legal Proceedings
Medtronic Sofamor Danek USA, Inc. Litigation
As previously disclosed, in August 2008, Medtronic Sofamor Danek USA, Inc. and its related
entities (Medtronic) filed suit against NuVasive in the United States District Court for the
Southern District of California (Medtronic Litigation), alleging that certain of NuVasives
products infringe, or contribute to the infringement of, twelve U.S. patents assigned or licensed
to Medtronic. Three of the patents were later withdrawn by Medtronic, leaving nine patents.
NuVasive brought counterclaims against Medtronic alleging infringement of certain of NuVasives
patents. Because of the number of patents involved, each side selected three patents to proceed
with in the first phase of the litigation. The initial phase of the case includes three Medtronic
patents and one NuVasive patent. Trial on the initial phase of the case is scheduled to begin
August 30, 2011. A full schedule for the second phase of the lawsuit has not yet been set by the
Court. NuVasive believes its own claims have merit and that Medtronics claims lack merit. At March
31, 2011, the probable outcome of this litigation cannot be determined, nor can the Company
estimate a range of potential loss. Accordingly, in accordance with the authoritative guidance on
the evaluation of contingencies, the Company has not recorded an accrual related to this
litigation.
Trademark Infringement Litigation
In September 2009, Neurovision Medical Products, Inc. (NMP) filed suit against NuVasive in the
U.S. District Court for the Central District of California (Case No. 2:09-cv-06988-R-JEM) alleging
trademark infringement and unfair competition. NMP sought cancellation of NuVasives NeuroVision
trademark registrations, injunctive relief and damages based on NMPs common law use of the
Neurovision mark. On November 23, 2009, the Company denied the allegations in NMPs complaint.
After trial of the matter, on October 25, 2010 an unfavorable jury verdict was delivered against
the Company relating to its use of the NeuroVision trade name. The verdict awarded damages to NMP
of $60.0 million. On January 3, 2011, the Court ordered a judgment be entered in the case in the
amount of $60.0 million, and granted a permanent injunction prohibiting the Companys use of the
NeuroVision name for marketing purposes. The Company sought emergency relief, and on February 3,
2011, the Ninth Circuit Court of Appeals stayed enforcement of the injunction. The Company intends
to timely appeal the judgment and permanent injunction. During pendency of the appeal, the Company
may be required to post a supersedeas bond or escrow funds to secure the amount of the judgment,
plus interest, attorneys fees and costs. However, any payment of damages will be delayed while the
appeals process runs its course, which could take up to two years. The Company continues to believe
that the verdict is not supported by the facts or by applicable law. The Company, based on its own
assessment as well as that of outside counsel, believes that the trial court committed a number of
prejudicial legal errors and that these errors were significant, making the possibility of reversal
of the judgment on appeal and/or a new trial probable. Accordingly, at March 31, 2011, in
accordance with the authoritative guidance on the evaluation of contingencies, the Company has not
recorded an accrual related to this litigation. The Company may be required to record an expense
related to this damage award in the future.
Contingencies
The Company is party to certain claims and legal actions arising in the normal course of
business. The Company does not expect any such claims and legal actions to have a material adverse
effect on its business, results of operations or financial condition.
14. Subsequent Event
During
March and April 2011, the Company renegotiated a supply agreement with Ceremed, Inc.
(Ceremed). In connection with that transaction, the Company made an $8.0 million payment in March
2011, which amount was returned to the Company in full during April 2011 in exchange for a future
payment of $5.0 million from the Company to Ceremed, which is expected to be made in the three
months ended June 30, 2011.
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
Forward-Looking Statements May Prove Inaccurate
You should read the following discussion of our financial condition and results of operations
in conjunction with the unaudited condensed consolidated financial statements and the notes to
those statements included in this report. This discussion may contain forward-looking statements
that involve risks and uncertainties. Our actual results may differ materially from those
anticipated in these forward-looking statements as a result of certain factors, such as those set
forth under heading Risk Factors, and elsewhere in this report, and similar discussions in our
other Securities and Exchange Commission filings, including our Annual Report on Form
10-K for the year ended December 31, 2010. We do not intend to update these forward looking
statements to reflect future events or circumstances.
15
Overview
We are a medical device company focused on developing minimally disruptive surgical products
and procedures for the spine. Our currently-marketed product portfolio is focused on applications
for spine fusion surgery, including biologics, a combined market estimated to exceed $7.7 billion
globally in 2011. Our principal product offering includes a minimally disruptive surgical platform
called Maximum Access Surgery, or MAS®, as well as a growing offering of biologics,
cervical and motion preservation products. Our spine surgery product line offerings, which include
products for the thoracolumbar spine, the cervical spine, and a set of motion preservation product
offerings still under development, are primarily used to enable access to the spine and to perform
restorative and fusion procedures in a minimally disruptive fashion. Our biologic product line
offerings include allograft (donated human tissue), FormaGraft®, a collagen synthetic
product used to aid the fusion process, and Osteocel® Plustm, an
allograft cellular matrix containing viable mesenchymal stem cells, or MSCs, to aid in spinal
fusion. We focus significant research and development efforts to expand our MAS product platform,
advance the applications of our unique technology to additional procedures and develop motion
preserving products such as our total disc replacement products. We dedicate significant resources
toward training spine surgeons on our unique technology and products. Currently, we are training
over 500 surgeons annually, which includes surgeons new to our MAS product platform as well as
surgeons previously trained on our MAS product platform who are attending advanced training
programs.
Our MAS platform, with the unique advantages provided by our nerve monitoring systems, enables
an innovative lateral procedure known as eXtreme Lateral Interbody Fusion, or XLIF®, in
which surgeons access the spine for a fusion procedure from the side of the patients body, rather
than from the front or back. Our MaXcess® instruments provide access to the spine in a
manner that affords direct visualization and our nerve monitoring systems allow surgeons to avoid
critical nerves.
In the past certain insurance providers have adopted policies of not providing reimbursement
for the XLIF procedure. We have worked with our surgeon customers and certain surgical societies
who, in turn, have worked with these insurance providers to supply the information required to
categorize the XLIF procedure as a procedure entitled to reimbursement under their policies. Most
major insurance companies provide reimbursement for XLIF procedures, however certain smaller
regional carriers have policies against coverage of XLIF. NuVasive cannot offer definitive time
frames or final outcomes regarding reversal of the non-coverage policies, as the process is
dictated by the third-party insurance providers. To date, we have not experienced significant lack
of payment for our procedures based on these policies.
Factors arising from third parties such as prolonged interaction with regulatory agencies,
general pushback from private payers on any of our procedures, devices, or services, industry
specific taxes, and other external factors may have a material impact on our business. We have
begun to incur incremental expenditures to address these type of issues regionally and nationally
as deemed necessary. Such advocacy for improvements in the regulatory approval process, payer
coverage of new technologies, and policies that facilitate innovation to improve spine care are
likely to become an ongoing expense.
In recent years, we have significantly expanded our product offering relating to procedures in
the cervical spine as well as in the area of biologics. Our cervical product offering now provides
a full set of solutions for cervical fusion surgery, including both allograft and
CoRoent® implants, as well as cervical plating and posterior fixation products. In 2009,
we acquired Cervitech®, Inc. (Cervitech), a company focused on gaining regulatory
approval of the PCM® cervical disc system, a motion preserving total disc replacement
device. This strategic acquisition allows us the potential to accelerate our entry into the growing
mechanical cervical disc replacement market. In the first quarter of
2010, we filed a PMA
application with the U.S. Food and Drug Administration for
approval of the PCM cervical disc system.
Approval, if obtained, would further strengthen our cervical product offering and should enable us
to continue our trend of increasing our market share.
In 2009 we purchased forty percent (40%) of the capital stock of Progentix Orthobiology, B.V.
(Progentix), a company organized under the laws of the Netherlands, from existing shareholders for
$10.0 million in cash (the Initial Investment). Progentix has as its objective the development and
exploitation of knowledge and technology in the field of synthetic bone graft materials to aid in
the healing and generation of human bone.
We have an active product development pipeline focused on expanding our current fusion product
platform as well as products designed to preserve spinal motion.
The majority of our revenues are derived from the sale of disposables and implants, and we
expect this trend to continue for the foreseeable future. We loan our proprietary software-driven
nerve monitoring systems and surgical instrument sets at no cost to
16
surgeons and hospitals that purchase disposables and implants for use in individual
procedures. In addition, we place our proprietary software-driven nerve monitoring systems, MaXcess
and other MAS or cervical surgical instrument sets with hospitals for an extended period at no
up-front cost to them. Our implants and disposables are currently sold and shipped from our primary
distribution and warehousing operations facility located in Memphis, Tennessee. We recognize
revenue for disposables or implants used upon receiving acknowledgement of a purchase order from
the hospital indicating product use or implantation. In addition, we sell an immaterial number of
MAS instrument sets, MaXcess devices, and our proprietary software-driven nerve monitoring systems.
To date, we have derived less than 5% of our total revenues from these sales.
Through March 31, 2011, substantially all of our operations are located in the United States
and substantially all of our sales have been generated in the United States. We sell our products
in the United States through a sales force comprised of exclusive independent sales agents and our
own directly-employed sales professionals; both selling only NuVasive spine surgery products. Our
sales force provides a delivery and consultative service to our surgeon and hospital customers and
is compensated based on sales and product placements in their territories. Sales force commissions
are reflected in our statement of income in the sales, marketing and administrative expense line.
We expect to continue to expand our distribution channel. Beginning late in 2007 and continuing
today, we are continuing our expansion of international sales efforts with the focus on European,
Asian and Latin American markets. Our international sales force is comprised of directly-employed
exclusive shareowners as well as exclusive distributors and independent sales agents.
Results of Operations
Revenue
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
|
|
(dollars in thousands) |
|
2011 |
|
2010 |
|
$ Change |
|
% Change |
Three months ended |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Spine Surgery Products |
|
$ |
101,908 |
|
|
$ |
89,151 |
|
|
|
|
|
|
|
|
|
Biologics |
|
|
22,558 |
|
|
|
19,936 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Revenue |
|
$ |
124,466 |
|
|
$ |
109,087 |
|
|
$ |
15,379 |
|
|
|
14 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Our spine surgery product line offerings, which include products for the thoracolumbar spine,
the cervical spine, and a set of motion preservation product offerings still under development, are
primarily used to enable access to the spine and to perform restorative and fusion procedures in a
minimally disruptive fashion. Our biologics product line offerings include allograft (donated human
tissue), FormaGraft, a collagen synthetic product used to aid the fusion process, and Osteocel
Plus, an allograft cellular matrix containing viable mesenchymal stem cells, or MSCs, to aid in
spinal fusion.
The continued adoption of minimally invasive procedures for spine has led to the continued
expansion of our innovative lateral procedure known as eXtreme Lateral Interbody Fusion, or XLIF,
in which surgeons access the spine for a fusion procedure from the side of the patients body,
rather than from the front or back. The execution of our strategy of expanding our product offering
for the lumbar region and addressing broader indications further up the spine in the thoracic and
cervical regions has contributed to strong revenue growth. In addition, increased market acceptance
in our international markets contributed to the increase in revenues noted for the periods
presented. We expect the continued adoption of our XLIF procedure and deeper penetration into
existing accounts and our newer international markets as our sales force executes on the strategy
of selling the full mix of our products; however, recent changes in payer and hospital behavior in
the United States have created less predictability in the U.S. lumbar portion of the spine market
and impacted the overall spine markets growth rate. Accordingly, we believe that our growth in
revenue in 2011 will be more weighted towards increased sales of our cervical offerings, our biologics
product line and in our international businesses.
Our total revenues
increased $15.4 million in the three months ended March 31, 2011
representing total revenue growth of 14% for the three months ended March 31, 2011, compared to the
same period in 2010. Revenue from our Spine Surgery Products
increased $12.8 million, or 14%, in
the three months ended March 31, 2011 compared to the same period in 2010. Revenue from our
Biologics product line increased $2.6 million, or 13%, in the three months ended March 31, 2011
compared to the same period in 2010. Total revenues were impacted by small unfavorable changes in
price of less than 2% in the three months ended March 31, 2011 compared to the same period in 2010.
17
Cost of Goods Sold, excluding amortization of purchased technology
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
|
|
(dollars in thousands) |
|
2011 |
|
2010 |
|
$ Change |
|
% Change |
Three months ended |
|
$ |
23,526 |
|
|
$ |
19,443 |
|
|
$ |
4,083 |
|
|
|
21 |
% |
% of revenue |
|
|
19 |
% |
|
|
18 |
% |
|
|
|
|
|
|
|
|
Cost of goods sold consists of purchased goods, inventory-related costs and royalty expenses.
Cost of goods sold as a percentage of revenue increased slightly for the three months ended
March 31, 2011 compared to the same period in 2010, primarily from mix shifting within our domestic
product portfolio, with secondary effects from the growth in our lower margin international
businesses as well as impacts from pricing.
We expect cost of goods sold, as a percentage of revenue, to remain consistent at
approximately 19% due to the expected continued increased revenue contribution from our lower
margin biologics and international businesses, roughly offset by new product introductions that can
capture some price premium.
Operating Expenses
Sales, Marketing and Administrative
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
|
|
(dollars in thousands) |
|
2011 |
|
2010 |
|
$ Change |
|
% Change |
Three months ended |
|
$ |
84,220 |
|
|
$ |
74,661 |
|
|
$ |
9,559 |
|
|
|
13 |
% |
% of revenue |
|
|
68 |
% |
|
|
68 |
% |
|
|
|
|
|
|
|
|
Sales, marketing and administrative expenses consist primarily of compensation, commission and
training costs for personnel engaged in sales, marketing and customer support functions;
distributor commissions; depreciation expense for surgical instrument sets; shipping costs; surgeon
training costs; shareowner (employee) related expenses for our administrative functions; and
third-party professional service fees.
The increases in sales, marketing and administrative expenses principally result from growth
in our revenue and the overall growth of the Company, including: expenses that tend to vary based
on revenue such as commissions, depreciation expense for loaned surgical instrument sets, worldwide
sales force headcount and shipping; expenses associated with investments in our worldwide
infrastructure such as operating systems and real estate; legal expenses; and non-sales related
headcount growth. As a percentage of revenue, sales, marketing and administrative expenses remained
constant for the three months ended March 31, 2011 compared to the same period in 2010 principally
as a result of increased shareowner related expenses, offset by increased operating leverage in our
expenses relative to the 14% growth in revenue for the three months ended March 31, 2011 compared
to 2010.
Excluding the impact resulting from a change in an accounting estimate related to the useful
life of certain surgical instrument sets, costs that tend to vary
based on revenue increased $1.9
million for the three months ended March 31, 2011, compared to the same period in 2010. This
increase is slightly less than our increased revenue growth of 14% in the first three months of
2011 as compared to the same period in 2010. Effective January 1, 2011, we changed the useful life
of certain surgical instrument sets from three to four years. This change, which was accounted for
as a change in accounting estimate, resulted in approximately $1.7 million less depreciation
expense than would have been recorded had the useful life of these assets not been extended.
Compensation and other shareowner related expenses for our marketing and administrative
support functions increased $5.3 million for the three months ended March 31, 2011 compared to the
same period in 2010 due to increased compensation and other shareowner related expenses resulting
from additions to our headcount and an increase in performance-based compensation. Stock-based
compensation increased $1.7 million for the three months ended March 31, 2011 compared to the same
period in 2010, primarily related to an increase in stock-based awards granted to shareowners
associated with the continued increase in headcount and our fiscal 2011 annual grants.
In addition to the items discussed above, legal expenses increased $1.1 million for the three
months ended March 31, 2011 as compared to the same period in 2010 resulting primarily from
increased Medtronic-related litigation costs and legal costs incurred in connection with the
NeuroVision trademark infringement litigation. Acquisition-related costs increased $0.6 million for
the three months ended March 31, 2011 as compared to the same period in 2010 primarily attributable
to the accretion of the contingent consideration liabilities incurred in the three months ended
March 31, 2011, with no comparable expense during the same period in
18
2010. In addition, during the three months ended March 31, 2010, expenses were lower due to a
recovery of an international receivable totaling $1.0 million, for which no comparable reduction in
expenses occurred during the same period in 2011.
On a long-term basis, as a percentage of revenue, we expect total sales, marketing and
administrative costs to continue to decrease moderately over time.
Research and Development.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
|
|
(dollars in thousands) |
|
2011 |
|
2010 |
|
$ Change |
|
% Change |
Three months ended |
|
$ |
10,769 |
|
|
$ |
10,699 |
|
|
$ |
70 |
|
|
|
1 |
% |
% of revenue |
|
|
9 |
% |
|
|
10 |
% |
|
|
|
|
|
|
|
|
Research and development expense consists primarily of product research and development,
clinical trial and study costs, regulatory and clinical functions, and shareowner related expenses.
In the last several years, we have introduced numerous new products and product enhancements
that have significantly expanded our MAS platform, enhanced the applications of the XLIF procedure,
expanded our offering of cervical products, and moved closer to entering into the growing motion
preservation market. We have also acquired complementary and strategic assets and technology,
particularly in the area of biologics. We are developing proprietary total disc replacement devices
for lateral lumbar spine applications and separately for cervical spine applications, which are
currently in different phases of clinical trials and related studies. We anticipate continuing to
incur costs related to such clinical trials and studies through at least 2011.
Compensation and other shareowner related expenses, including stock-based compensation,
increased $0.9 million for the three months ended March 31, 2011 primarily due to increased
compensation and other shareowner related expenses resulting from additions to the Companys
headcount to support our product development and enhancement efforts and an increase in
performance-based compensation for the three months ended March 31, 2011 as compared to the same
period in 2010. These increased expenses were offset by a decrease of expenses in connection with a
supply agreement related to the bone graft product being developed by Progentix of $0.4 million
incurred in 2010 with no comparable expense during the same period in 2011, and a decrease of $0.4
million expenses incurred by Progentix.
For the foreseeable future, as a percentage of revenue, we expect total research and
development costs to remain around 9% in support of our ongoing development and planned clinical
trial and study related activities.
Amortization of Intangible Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
|
|
(dollars in thousands) |
|
2011 |
|
2010 |
|
$ Change% |
|
Change |
Three months ended: |
|
$ |
1,342 |
|
|
$ |
1,350 |
|
|
$ |
(8 |
) |
|
|
(1 |
%) |
% of total revenue |
|
|
1 |
% |
|
|
1 |
% |
|
|
|
|
|
|
|
|
Amortization of intangible assets relates to amortization of finite-lived intangible assets
acquired. Although amortization expense for the three months ended March 31, 2011 compared to the
same period in 2010 remained relatively constant, we expect expenses recorded in connection with
the amortization of intangible assets to continue to increase in absolute dollars for the
foreseeable future as amortization of acquired in-process research and development commences once
acquired research and development projects reach technological feasibility.
19
Interest and Other Expense, Net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
|
|
(dollars in thousands) |
|
2011 |
|
2010 |
|
$ Change |
|
% Change |
Three months ended: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
$ |
183 |
|
|
$ |
189 |
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
(1,771 |
) |
|
|
(1,669 |
) |
|
|
|
|
|
|
|
|
Other income, net |
|
|
497 |
|
|
|
117 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total interest and other expense, net |
|
$ |
(1,091 |
) |
|
$ |
(1,363 |
) |
|
$ |
(272 |
) |
|
|
20 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of revenue |
|
|
1 |
% |
|
|
1 |
% |
|
|
|
|
|
|
|
|
Interest and other expense, net, consists primarily of interest income earned on marketable
securities offset by interest expense incurred related to our outstanding convertible debt.
Interest and other expense, net, for the three months ended March 31, 2011 compared to the same
period in 2010 remained relatively constant.
Income Tax Expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
|
|
(dollars in thousands) |
|
2011 |
|
2010 |
|
$ Change |
|
% Change |
Three months ended: |
|
$ |
1,540 |
|
|
$ |
865 |
|
|
$ |
675 |
|
|
|
78 |
% |
Effective income tax rate |
|
|
44 |
% |
|
|
55 |
% |
|
|
|
|
|
|
|
|
We recorded income tax expense of $1.5 million and $0.9 million for the three months ended
March 31, 2011 and 2010, respectively. The effective income tax rate for the three months ended
March 31, 2011 was 44%, which is based on an estimate of our annual effective income tax rate. We
update our annual effective income tax rate each quarter and if the estimated effective income tax
rate changes, a cumulative adjustment is made. Our annual effective income tax rate for 2011 is
expected to be higher than the U.S. federal statutory rate of 35% primarily due to state income
taxes, net of federal benefit, estimates for certain non-deductible expenses, and foreign losses
expected to be incurred for which no benefit can be recorded.
Stock-Based Compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
|
|
|
(dollars in thousands) |
|
2011 |
|
|
2010 |
|
|
$ Change |
|
% Change |
Three months ended: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales, marketing and administrative expense |
|
$ |
7,335 |
|
|
$ |
5,680 |
|
|
|
|
|
|
|
|
|
Research and development expense |
|
|
611 |
|
|
|
754 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stock-based compensation expense |
|
$ |
7,946 |
|
|
$ |
6,434 |
|
|
$ |
1,512 |
|
|
|
24 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of revenue |
|
|
6 |
% |
|
|
6 |
% |
|
|
|
|
|
|
|
|
Stock-based compensation related to stock awards is recognized and amortized on an accelerated
basis in accordance with authoritative guidance. The increase in stock-based compensation of
approximately $1.5 million for the three months ended March 31, 2011 compared to the same period in
2010 is primarily attributed to an increase in the number of awards granted to shareowners
associated with the continued increase in headcount year over year for the periods presented, and
the fiscal 2011 annual grants.
Liquidity, Cash Flows and Capital Resources
Since our inception in 1997, we have incurred significant losses and as of March 31, 2011, we
had an accumulated deficit of approximately $109.1 million. Through 2008, our operations were
funded primarily with proceeds from the sale of our equity securities, which at December 31, 2008,
totaled $284.5 million since inception, including $210.1 million sold in the public markets. Since
2009, our operations have been funded primarily with our convertible debt proceeds issued in March
2008 as well as the positive cash flow generated from operations.
In March 2008, we issued $230.0 million principal amount of 2.25% Senior Convertible Notes due
2013 (the Notes). The net proceeds from the offering, after deducting the initial purchasers
discount and costs directly related to the offering, were approximately $208.4 million. We pay
2.25% interest per annum on the principal amount of the Notes, payable semi-annually in arrears in
cash on March 15 and September 15 of each year. Any notes not converted prior to March 15, 2013,
the maturity date, will be paid in cash.
20
Cash, cash equivalents and marketable securities was $225.8 million and $229.7 million at
March 31, 2011 and December 31, 2010, respectively. We believe that our existing cash, cash
equivalents and short-term marketable securities will be sufficient to meet our anticipated cash
needs for at least the next 12 months. Our future capital requirements will depend on many factors
including our rate of revenue growth, the timing and extent of spending to support development
efforts, the expansion of sales, marketing and administrative activities, the timing of
introductions of new products and enhancements to existing products, the continuing market
acceptance of our products and the expenditures associated with possible future acquisitions or
other business combination transactions.
We expect that cash provided by operating activities may fluctuate in future periods as a
result of a number of factors, including fluctuations in our operating results and working capital
requirements. In addition, as more fully discussed in Note 13 to the unaudited condensed
consolidated financial statements included in this Report, we may be required to post a supersedeas
bond or escrow fund to secure the recent $60.0 million judgment against us in connection with the
NeuroVision trademark infringement litigation. Including attorneys fees and interest during the
appeals period, this $60.0 million could reach approximately $63.0 million. Our anticipated cash
needs for the coming twelve month period have contemplated this potential requirement.
Cash Flows
The following table summarizes, for the periods indicated, selected items in our consolidated
statements of cash flows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
|
|
2011 |
|
2010 |
|
$ Change |
Three months ended: |
|
|
|
|
|
|
|
|
|
|
|
|
Cash provided by operating activities |
|
$ |
14,544 |
|
|
$ |
9,138 |
|
|
$ |
5,406 |
|
Cash provided by investing activities |
|
|
27,167 |
|
|
|
89 |
|
|
|
27,078 |
|
Cash (used in) provided by financing activities |
|
|
(284 |
) |
|
|
3,102 |
|
|
|
(3,386 |
) |
Effect of exchange rate changes on cash |
|
|
77 |
|
|
|
(78 |
) |
|
|
155 |
|
|
|
|
|
|
|
|
|
|
|
Increase in cash and cash equivalents |
|
$ |
41,504 |
|
|
$ |
12,251 |
|
|
$ |
29,253 |
|
|
|
|
|
|
|
|
|
|
|
Cash flows from operating activities
Cash provided by operating activities was $14.5 million for the three months ended March 31,
2011, as compared to $9.1 million for the same period in 2010. The $5.4 million increase in cash
provided by operating activities for the three months ended March, 31 2011 as compared to the same
period in 2010 is primarily due to improved collections from accounts receivable, increased
profitability and a decrease in amounts due to shareowners, offset by the use of $5.4 million more
cash to build inventory.
Cash flows from investing activities
Cash provided by investing activities was $27.2 million for the three months ended March 31,
2011, as compared to $0.1 million for the same period in 2010. The $27.1 million increase in cash
provided by investing activities for the three months ended March, 31 2011 as compared to the same
period in 2010 is primarily due to a net increase in our net sales of marketable securities of
$36.7 million, slightly offset by an $8.0 million payment made in connection with a supply
agreement (which was amended on April 1, 2011) and increased purchases of surgical instrument sets,
which are deployed to support our increasing revenue volume.
Cash flows from financing activities
Cash used in financing activities was $0.3 million for the three months ended March 31, 2011,
compared to $3.1 million provided by financing activities for the same period in 2010. The $3.4
million decrease in cash provided by financing activities for the three months ended March 31, 2011
as compared to the same period in 2010 is primarily due to a decrease in proceeds from the issuance
of common stock, offset by a decrease in long term other assets (cash used as collateral for
letters of credit) for the three months ended March 31, 2011.
Critical Accounting Policies and Estimates
Our discussion and analysis of our financial condition and results of operations is based upon
our unaudited condensed consolidated financial statements, which have been prepared in accordance
with accounting principles generally accepted in the United States (GAAP). The preparation of these
financial statements requires us to make estimates and judgments that affect the reported amounts
of assets, liabilities, revenues and expenses. On an ongoing basis, we evaluate our estimates
including those related
21
to bad debts, inventories, valuation of goodwill, intangibles and other long-term assets,
income taxes, stock-based compensation, and legal proceedings. We base our estimates on historical
experience and on various other assumptions we believe to be reasonable under the circumstances,
the results of which form the basis for making judgments about the carrying values of assets and
liabilities not readily apparent from other sources. Actual results may differ from these
estimates. Our critical accounting policies and estimates are discussed in our Annual Report on
Form 10-K for the fiscal year ended December 31, 2010 and there have been no material changes
during the three months ended March 31, 2011 except as follows:
Effective January 1, 2011, we changed the estimated useful lives of instrument sets that we
loan to or place with hospitals from three to four years.
New accounting requirements
Effective January 1, 2011, the Company adopted the FASBs updated guidance related to fair
value measurements and disclosures, which requires a reporting entity to disclose separately
information related to purchases, sales, issuances, and settlements in the reconciliation for fair
value measurements using significant unobservable inputs, or Level 3, to be included in the
rollforward of activity. The guidance is effective for interim or annual financial reporting
periods beginning after December 15, 2010. The Company has updated its disclosures to comply with
the updated guidance; however, adoption of the updated guidance did not have an impact on the
Companys consolidated results of operations or financial position.
Off-Balance Sheet Arrangements
We have not engaged in any off-balance sheet activities.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
There has been no material change in the Companys assessment of its sensitivity to market
risk since its presentation set forth in Item 7A, Quantitative and Qualitative Disclosures About
Market Risk, in its Annual Report on Form 10-K for the fiscal year ended December 31, 2010.
Item 4. Controls and Procedures
Disclosure Controls and Procedures. We maintain disclosure controls and procedures that are
designed to ensure that information required to be disclosed in our reports under the Securities
Exchange Act of 1934, as amended (Exchange Act), is recorded, processed, summarized and reported
within the timelines specified in the SECs rules and forms, and that such information is
accumulated and communicated to our management, including our Chief Executive Officer and Chief
Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. In
designing and evaluating the disclosure controls and procedures, management recognized that any
controls and procedures, no matter how well designed and operated, can only provide reasonable
assurance of achieving the desired control objectives, and in reaching a reasonable level of
assurance, management necessarily was required to apply its judgment in evaluating the cost-benefit
relationship of possible controls and procedures.
Under the supervision and with the participation of our management, including our Chief
Executive Officer and our Chief Financial Officer, we carried out an evaluation of the
effectiveness of the Companys disclosure controls and procedures (as such term is defined in
Exchange Act Rules 13a 15(e) and 15d 15(e)) as of March 31, 2011. Based on such evaluation,
our management has concluded that as of March 31, 2011, the Companys disclosure controls and
procedures are effective.
Changes in Internal Control over Financial Reporting. There has been no change to our internal
control over financial reporting during our most recent fiscal quarter that has materially
affected, or is reasonably likely to materially affect, our internal control over financial
reporting.
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
There have been no changes to the Legal Proceedings discussed in our Annual Report on Form
10-K for the fiscal year ended December 31, 2010, except as follows:
22
As reported by us previously, Medtronic Sofamor Danek USA, Inc. and its related entities
(Medtronic), on August 18, 2008, filed a
patent infringement lawsuit against NuVasive in the United States District Court for the
Southern District of California, alleging that certain of NuVasives products or methods, including
the XLIF® procedure, infringe, or contribute to the infringement of, twelve U.S.
patents. Three of the patents were later withdrawn by Medtronic leaving the following nine patents
in the lawsuit: Nos. 5,860,973; 5,772,661; 6,936,051; 6,936,050; 6,916,320; 6,945,933; 6,969,390;
6,428,542; 6,592,586 assigned or licensed to Medtronic (Medtronic Patents). Medtronic is seeking
unspecified monetary damages and a court injunction against future infringement by NuVasive.
NuVasive has answered the complaint denying the allegations, and filed counterclaims seeking
dismissal of Medtronics complaint and a declaration that NuVasive has not infringed and currently
does not infringe any valid claim of the Medtronic Patents. Additionally, NuVasive has made
counterclaims against Medtronic seeking the following relief: (i) Medtronic being permanently
enjoined from charging that NuVasive has infringed or is infringing the Medtronic Patents; (ii) a
declaration that the Medtronic Patents are invalid; (iii) a declaration that the 5,860,973 and
5,772,661 patents are unenforceable due to inequitable conduct; and (iv) costs and reasonable
attorneys fees.
NuVasive filed an amended counterclaim on September 4, 2009, alleging that NuVasives U.S.
Patent Nos. 7,207,949; 7,582,058; and 7,470,236 are being infringed by Medtronics NIM-Eclipse
System and accessories and Quadrant products, and DLIF (Direct Lateral Interbody Fusion) surgical
technique. Medtronic, on June 23, 2009, filed a request for inter partes reexamination with the
Patent Office on NuVasives U.S. Patent No. 7,207,949. On October 14, 2009, Medtronic filed a
request for inter partes reexamination on NuVasives U.S. Patent No. 7,582,058. The Patent Office
granted both requests and issued rejections of the claims. Both reexaminations are pending.
Given the number of patents asserted in the litigation, the parties agreed to proceed on a
limited number of patents. The court determined to proceed only with patents that are not the
subject of active reexamination proceedings. As a result, the initial phase of the case includes
three Medtronic patents and one NuVasive patent. Trial on the initial phase of the case is
scheduled to begin August 30, 2011. A full schedule for the second phase of the lawsuit has not yet
been set by the Court.
Item 1A. Risk Factors
An investment in our common stock involves a high degree of risk. You should consider
carefully the risks and uncertainties described under Item 1A of Part I of our Annual Report on
Form 10-K filed with the Securities and Exchange Commission for the year ended December 31, 2010
(the Risk Factors), to which there have been no material changes, together with all other
information contained or incorporated by reference in this report before you decide to invest in
our common stock. If any of the risks described in this report or in our Annual Report actually
occurs, our business, financial condition, results of operations and our future growth prospects
could be materially and adversely affected. Under these circumstances, the trading price of our
common stock could decline, and you may lose all or part of your investment.
23
Item 6. Exhibits
EXHIBIT INDEX
|
|
|
Exhibit No |
|
Description |
|
|
|
3.1
|
|
Restated Certificate of Incorporation
(incorporated by reference to our Quarterly
Report on Form 10-Q filed with the
Commission on August 13, 2004) |
|
|
|
3.2
|
|
Restated Bylaws (incorporated by reference
to our Current Report on Form 8-K filed
with the Commission on December 15, 2008) |
|
|
|
10.1
|
|
Form of Compensation Letter Agreement dated
March 4, 2011 between NuVasive, Inc. and
each of the following: Keith C. Valentine,
Patrick Miles, Jason M. Hannon, Michael J.
Lambert, Jeffrey P. Rydin, Tyler P.
Lipschultz and Craig E. Hunsaker (filed herewith) |
|
|
|
31.1
|
|
Certification of Chief Executive Officer
pursuant to Rules 13a-14 and 15d-14
promulgated under the Securities Exchange
Act of 1934, as amended |
|
|
|
31.2
|
|
Certification of Chief Financial Officer
pursuant to Rules 13a-14 and 15d-14
promulgated under the Securities Exchange
Act of 1934, as amended |
|
|
|
32*
|
|
Certifications of Chief Executive Officer
and Chief Financial Officer pursuant to 18
U.S.C. Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of
2002 |
|
|
|
101**
|
|
XBRL Instance Document |
|
|
|
101**
|
|
XBRL Taxonomy Extension Schema Document |
|
|
|
101**
|
|
XBRL Taxonomy Calculation Linkbase Document |
|
|
|
101**
|
|
XBRL Taxonomy Label Linkbase Document |
|
|
|
101**
|
|
XBRL Taxonomy Presentation Linkbase Document |
|
|
|
* |
|
These certifications are being furnished solely to
accompany this annual report pursuant to 18 U.S.C. Section
1350, and are not being filed for purposes of Section 18 of
the Securities Exchange Act of 1934 and are not to be
incorporated by reference into any filing of NuVasive,
Inc., whether made before or after the date hereof,
regardless of any general incorporation language in such
filing. |
|
** |
|
Pursuant to applicable securities laws and regulations, we
are deemed to have complied with the reporting obligation
relating to the submission of interactive data files in
such exhibits and are not subject to liability under any
anti-fraud provisions of the federal securities laws as
long as we have made a good faith attempt to comply with
the submission requirements and promptly amend the
interactive data files after becoming aware that the
interactive data files fail to comply with the submission
requirements. Users of this data are advised that, pursuant
to Rule 406T, these interactive data files are deemed not
filed and otherwise are not subject to liability. |
24
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
NuVasive, Inc.
Date: May 6, 2011
|
|
|
|
|
|
By: |
/s/ Alexis V. Lukianov
|
|
|
|
Alexis V. Lukianov |
|
|
|
Chairman and Chief Executive Officer |
|
Date: May 6, 2011
|
|
|
|
|
|
By: |
/s/ Michael J. Lambert
|
|
|
|
Michael J. Lambert |
|
|
|
Executive Vice President and Chief Financial Officer |
|
25
EXHIBIT INDEX
|
|
|
Exhibit No |
|
Description |
|
|
|
3.1
|
|
Restated Certificate of Incorporation
(incorporated by reference to our Quarterly
Report on Form 10-Q filed with the
Commission on August 13, 2004) |
|
|
|
3.2
|
|
Restated Bylaws (incorporated by reference
to our Current Report on Form 8-K filed
with the Commission on December 15, 2008) |
|
|
|
10.1
|
|
Form of Compensation Letter Agreement dated
March 4, 2011 between NuVasive, Inc. and
each of the following: Keith C. Valentine,
Patrick Miles, Jason M. Hannon, Michael J.
Lambert, Jeffrey P. Rydin, Tyler P.
Lipschultz and Craig E. Hunsaker (filed herewith) |
|
|
|
31.1
|
|
Certification of Chief Executive Officer
pursuant to Rules 13a-14 and 15d-14
promulgated under the Securities Exchange
Act of 1934, as amended |
|
|
|
31.2
|
|
Certification of Chief Financial Officer
pursuant to Rules 13a-14 and 15d-14
promulgated under the Securities Exchange
Act of 1934, as amended |
|
|
|
32*
|
|
Certifications of Chief Executive Officer
and Chief Financial Officer pursuant to 18
U.S.C. Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of
2002 |
|
|
|
101**
|
|
XBRL Instance Document |
|
|
|
101**
|
|
XBRL Taxonomy Extension Schema Document |
|
|
|
101**
|
|
XBRL Taxonomy Calculation Linkbase Document |
|
|
|
101**
|
|
XBRL Taxonomy Label Linkbase Document |
|
|
|
101**
|
|
XBRL Taxonomy Presentation Linkbase Document |
|
|
|
* |
|
These certifications are being furnished solely to
accompany this annual report pursuant to 18 U.S.C. Section
1350, and are not being filed for purposes of Section 18 of
the Securities Exchange Act of 1934 and are not to be
incorporated by reference into any filing of NuVasive,
Inc., whether made before or after the date hereof,
regardless of any general incorporation language in such
filing. |
|
** |
|
Pursuant to applicable securities laws and regulations, we
are deemed to have complied with the reporting obligation
relating to the submission of interactive data files in
such exhibits and are not subject to liability under any
anti-fraud provisions of the federal securities laws as
long as we have made a good faith attempt to comply with
the submission requirements and promptly amend the
interactive data files after becoming aware that the
interactive data files fail to comply with the submission
requirements. Users of this data are advised that, pursuant
to Rule 406T, these interactive data files are deemed not
filed and otherwise are not subject to liability. |
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