e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
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þ |
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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 June 30, 2010
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.) |
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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 Web site, 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 July 30, 2010, there were 39,384,692 shares of the registrants common stock outstanding.
NUVASIVE, INC.
QUARTERLY REPORT ON FORM 10-Q
June 30, 2010
TABLE OF CONTENTS
2
PART I. FINANCIAL INFORMATION
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Item 1. |
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Financial Statements |
NUVASIVE, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except par value)
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June 30, |
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December 31, |
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2010 |
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2009 |
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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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$ |
67,513 |
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$ |
65,413 |
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Short-term marketable securities |
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111,666 |
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99,279 |
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Accounts receivable, net |
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68,230 |
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58,462 |
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Inventory |
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93,106 |
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90,191 |
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Prepaid expenses and other current assets |
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3,768 |
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3,757 |
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Total current assets |
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344,283 |
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317,102 |
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Property and equipment, net |
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89,801 |
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82,602 |
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Long-term marketable securities |
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34,046 |
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39,968 |
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Intangible assets, net |
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100,833 |
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103,338 |
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Goodwill |
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101,938 |
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101,938 |
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Other assets |
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14,781 |
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7,872 |
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Total assets |
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$ |
685,682 |
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$ |
652,820 |
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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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$ |
38,337 |
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$ |
33,302 |
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Accrued payroll and related expenses |
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13,088 |
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19,111 |
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Royalties payable |
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2,484 |
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2,334 |
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Total current liabilities |
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53,909 |
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54,747 |
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Convertible senior 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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30,876 |
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30,694 |
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Other long-term liabilities |
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27,810 |
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27,528 |
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Commitments and contingencies |
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Noncontrolling interests |
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12,714 |
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13,629 |
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Stockholders equity: |
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Common stock, $0.001 par value; 70,000
shares authorized, 39,344 and 38,774 issued
and outstanding at June 30, 2010 and
December 31, 2009, respectively |
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39 |
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39 |
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Additional paid-in capital |
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513,072 |
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485,757 |
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Accumulated other comprehensive income (loss) |
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(849 |
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126 |
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Accumulated deficit |
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(181,889 |
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(189,700 |
) |
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Total stockholders equity |
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330,373 |
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296,222 |
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Total liabilities and stockholders equity |
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$ |
685,682 |
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$ |
652,820 |
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See accompanying notes to unaudited condensed consolidated financial statements.
3
NUVASIVE, INC.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
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Three Months Ended |
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Six Months Ended |
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June 30, |
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June 30, |
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2010 |
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2009 |
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2010 |
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2009 |
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Revenues |
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$ |
119,584 |
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$ |
88,481 |
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$ |
228,671 |
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$ |
168,490 |
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Cost of goods sold, excluding amortization of purchased technology |
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21,014 |
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14,235 |
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40,457 |
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27,234 |
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Gross profit |
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98,570 |
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74,246 |
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188,214 |
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141,256 |
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Operating expenses: |
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Sales, marketing and administrative |
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77,726 |
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60,274 |
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152,387 |
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120,801 |
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Research and development |
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11,205 |
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8,178 |
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21,904 |
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16,764 |
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Amortization of intangible assets |
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1,355 |
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1,372 |
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2,705 |
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2,708 |
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Total operating expenses |
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90,286 |
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69,824 |
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176,996 |
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140,273 |
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Interest income |
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178 |
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383 |
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367 |
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1,115 |
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Interest expense |
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(1,668 |
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(2,060 |
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(3,337 |
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(3,830 |
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Other income (expense), net |
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(30 |
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93 |
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87 |
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135 |
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Total interest and other income (expense), net |
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(1,520 |
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(1,584 |
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(2,883 |
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(2,580 |
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Income (loss) before income tax expense |
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6,764 |
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2,838 |
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8,335 |
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(1,597 |
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Income tax expense |
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574 |
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526 |
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1,439 |
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623 |
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Consolidated net income (loss) |
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$ |
6,190 |
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$ |
2,312 |
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$ |
6,896 |
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$ |
(2,220 |
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Net loss attributable to noncontrolling interests |
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$ |
(533 |
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$ |
(453 |
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$ |
(915 |
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$ |
(683 |
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Net income (loss) attributable to NuVasive, Inc. |
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$ |
6,723 |
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$ |
2,765 |
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$ |
7,811 |
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$ |
(1,537 |
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Net income (loss) per share attributable to NuVasive, Inc.: |
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Basic net income (loss) per share |
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$ |
0.17 |
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$ |
0.07 |
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$ |
0.20 |
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$ |
(0.04 |
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Diluted net income (loss) per share |
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$ |
0.17 |
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$ |
0.07 |
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$ |
0.19 |
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$ |
(0.04 |
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Weighted average shares outstanding: |
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Basic |
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39,242 |
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36,910 |
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39,071 |
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36,639 |
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Diluted |
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40,694 |
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38,301 |
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40,383 |
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36,639 |
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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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Six Months Ended |
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June 30, |
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2010 |
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2009 |
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Operating activities: |
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Consolidated net income (loss) |
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$ |
6,896 |
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$ |
(2,220 |
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Adjustments to reconcile consolidated net income (loss) to net cash provided by operating activities: |
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Depreciation and amortization |
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17,065 |
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12,811 |
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Stock-based compensation |
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13,983 |
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12,999 |
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Allowance for excess and obsolete inventory |
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906 |
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2,038 |
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Allowance for doubtful accounts and sales return reserves, net of write-offs |
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(1,007 |
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1,290 |
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Other non-cash adjustments |
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2,773 |
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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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(8,514 |
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2,221 |
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Inventory |
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(4,258 |
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(19,939 |
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Prepaid expenses and other current assets |
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(1,397 |
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(694 |
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Accounts payable and accrued liabilities |
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4,588 |
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332 |
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Accrued payroll and related expenses |
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(5,574 |
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(1,272 |
) |
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Net cash provided by operating activities |
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25,461 |
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7,566 |
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Investing activities: |
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Cash paid for acquisitions and investments |
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(44,055 |
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Purchases of property and equipment |
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(22,059 |
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(12,440 |
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Purchases of marketable securities |
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(95,015 |
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(29,678 |
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Sales of marketable securities |
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88,028 |
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76,270 |
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Net cash used in investing activities |
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(29,046 |
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(9,903 |
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Financing activities: |
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Issuance of common stock |
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11,963 |
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6,297 |
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Tax benefits related to stock-based compensation awards |
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1,369 |
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Other assets |
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(7,481 |
) |
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Net cash provided by financing activities |
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5,851 |
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6,297 |
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Effect of exchange rate changes on cash |
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(166 |
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48 |
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Increase in cash and cash equivalents |
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2,100 |
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4,008 |
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Cash and cash equivalents at beginning of period |
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65,413 |
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132,318 |
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Cash and cash equivalents at end of period |
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$ |
67,513 |
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$ |
136,326 |
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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 designs, develops and markets products for the surgical treatment of spine disorders. The
Company began commercializing its products in 2001. Its product portfolio is focused primarily 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 set of
offerings in the biologics, cervical and motion preservation areas. 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. The Company also focuses significant research and
development efforts on MAS and motion preservation products in the areas of (i) fusion procedures
in the lumbar and thoracic spine; (ii) cervical fixation products; and (iii) motion preservation
products such as the Companys total disc replacement products. The Company dedicates significant
resources to sales and marketing efforts, including training spine surgeons on its unique
technology and products.
The Company loans its MAS systems to surgeons and hospitals who purchase disposables and
implants for use in individual procedures. In addition, NeuroVision®, 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 CoRoent® 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 NeuroVision systems to hospitals.
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.
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. 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, 2009
and for the six months ended June 30, 2010 and 2009 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, 2009 included in NuVasives
Annual Report on Form 10-K filed with the Securities and Exchange Commission. Operating results for
the six months ended June 30, 2010 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, 2009
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.
Reclassifications
Certain reclassifications have been made to the prior year consolidated balance sheet to
conform to the current year presentation.
6
Business Combinations
In accordance with authoritative guidance for business combinations, goodwill and other
long-term liabilities on the December 31, 2009 condensed consolidated balance sheet have been
retrospectively adjusted to reflect the finalization of the purchase price allocation for assets
and liabilities acquired from Cervitech®, Inc. (Cervitech) in May 2009 (Note 3).
2. Significant Accounting Policies
Recently Adopted Accounting Standards
Variable Interest Entities
Effective January 1, 2010, the Company adopted a newly issued accounting standard which
provides guidance for the consolidation of variable interest entities and requires an enterprise to
determine whether its variable interest or interests give it a controlling financial interest in a
variable interest entity. This amended consolidation guidance for variable interest entities
replaces the existing quantitative approach for identifying which enterprise should consolidate a
variable interest entity, which was based on which enterprise is exposed to a majority of the risks
and rewards, with a qualitative approach, based on which enterprise has both (1) the power to
direct the economically significant activities of the entity and (2) the obligation to absorb
losses of, or the right to receive benefits from, the entity that could potentially be significant
to the variable interest entity. The adoption of this standard did not have an impact on the
Companys consolidated results of operations or financial position. Determination about whether an
enterprise should consolidate a variable interest entity is required to be evaluated continuously
as changes to existing relationships or future transactions may result in the Company consolidating
or deconsolidating current or future business arrangements.
Fair Value Measurements Disclosures
Effective January 1, 2010, the Company adopted the FASBs updated guidance related to fair
value measurements and disclosures, which requires a reporting entity to disclose separately the
amounts of significant transfers in and out of Level 1 and Level 2 fair value measurements and to
describe the reasons for the transfers. In addition, in the reconciliation for fair value
measurements using significant unobservable inputs, or Level 3, a reporting entity should disclose
separately information related to purchases, sales, issuances, and settlements information to be
included in the rollforward of activity. The updated guidance also requires that an entity provide
fair value measurement disclosures for each class of assets and liabilities and disclosures about
the valuation techniques and inputs used to measure fair value for both recurring and non-recurring
fair value measurements for Level 2 and Level 3 fair value measurements. The guidance is effective
for interim or annual financial reporting periods beginning after December 15, 2009, except for the
disclosures about purchases, sales, issuances and settlements in the rollforward activity in Level
3 fair value measurements, which are effective for fiscal years beginning after December 15, 2010
and for interim periods within those fiscal years. Therefore, the Company has not yet adopted the
guidance with respect to the rollforward activity in Level 3 fair value measurements. 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. Cervitech® Inc. Acquisition
On May 8, 2009 (the Closing Date), the Company completed the purchase of all of the
outstanding shares of Cervitech, a Delaware corporation, for an initial payment of approximately
$49 million consisting of cash totaling approximately $25 million and the issuance of
638,261 shares of NuVasive common stock to certain stockholders of Cervitech. Cervitech, a New
Jersey based company, is focused on the clinical approval of the PCM® cervical disc
system, a motion preserving total disc replacement device in the United States. This acquisition
allows NuVasive the potential to accelerate its entry into the growing mechanical cervical disc
replacement market. In addition to the initial payment, the Company may be obligated to make an
additional milestone payment of $33 million if the U.S. Food and Drug Administration (FDA) issues
an approval order allowing the commercialization of Cervitechs PCM device in the United States
with an intended use for treatment of degenerative disc disease. The milestone payment may be made
in cash or a combination of cash and up to half in NuVasive common stock, at the Companys
discretion. The fair value of the contingent consideration at the Closing Date was determined to
be $29.7 million using a probability-weighted discounted cash flow model with the key assumptions
being the interest rate, the timing of expected approval and the probability assigned to the milestone being achieved.
7
The assets and liabilities of Cervitech were recorded at their respective acquisition date
estimated fair values, and identifiable intangible assets were recorded at fair value. As
previously disclosed, the preliminary allocation of the estimated purchase price was based on
managements preliminary valuation of the fair value of tangible assets, intangible assets and
in-process research and development acquired and liabilities assumed as of the Closing Date and
such estimates were subject to revision. During May 2010, the Company finalized the purchase
accounting adjustments to account for facts related to deferred tax assets and liabilities acquired
that existed at the Closing Date. Accordingly, the Company reduced the amount of Goodwill recorded
on the acquisition of Cervitech by $0.9 million retrospectively to the Closing Date as follows (in
thousands):
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Initial |
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Purchase |
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Revised |
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Estimate of |
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Price |
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Estimate of |
|
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Fair Value |
|
Adjustments |
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Fair Value |
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Goodwill |
|
$ |
55,443 |
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$ |
(945 |
) |
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$ |
54,498 |
|
Deferred income tax liabilities, net |
|
$ |
13,560 |
|
|
$ |
945 |
|
|
$ |
12,615 |
|
The final allocation of the purchase price at December 31, 2009 is presented in the following
table (in thousands):
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Estimated |
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|
Estimated Useful |
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Fair Value |
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|
Life |
|
Total current assets |
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$ |
1,233 |
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|
|
Property, plant and equipment |
|
|
59 |
|
|
|
|
|
Developed technology |
|
|
700 |
|
|
|
14 years |
|
Non-compete agreement |
|
|
100 |
|
|
|
2 years |
|
Trade name |
|
|
700 |
|
|
|
10 years |
|
In-process research and development |
|
|
34,800 |
|
|
|
14 years |
|
Goodwill |
|
|
54,498 |
|
|
|
|
|
Current liabilities |
|
|
(483 |
) |
|
|
|
|
Deferred income tax liabilities |
|
|
(12,615 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Total estimated purchase price allocation |
|
$ |
78,992 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Of the total $79.0 million purchase price, $34.8 million and $54.5 million was allocated to in-process research and development (IPR&D) and goodwill, respectively, based on
managements valuation of the fair value of the assets acquired and liabilities assumed on the
date of acquisition. The IPR&D, which has been capitalized as an indefinite-lived asset, relates to
the future commercialization of Cervitechs PCM device in the United States with an intended
use for treatment of degenerative disc disease. The Company submitted a premarket approval
(PMA) application for FDA approval for the PCM device in the first quarter of 2010, for which an approval date is not predictable. At June 30,
2010, the estimated remaining costs to reach FDA approval for this device is approximately $1.5
million.
Goodwill totaling $54.5 million represents the excess of the purchase price over the fair value of tangible and
identifiable intangible assets acquired and is due primarily to increased market penetration from future products and customers and
synergies expected from combining the PCM device with the Companys existing development
of motion preservation systems. This acquisition was nontaxable and, as a result, there is
no tax basis in goodwill. Accordingly, none of the goodwill associated with the Cervitech
acquisition is deductible for tax purposes. For the three and six months ended June 30, 2009, the
Companys consolidated results of operations include acquisition-related expenses incurred in
connection with the Cervitech acquisition of $0.5 million and $1.2 million, respectively, which are
included in sales, marketing and administrative expenses.
4. 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). The proceeds of the Loan
are to be utilized towards achievement of all milestones, as defined in the Preferred Stock
Purchase 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
to Progentix. At June 30, 2010, the Company had advanced Progentix $4 million in accordance with
the Loan Agreement. The Company has not provided additional financing to Progentix other than this
contractually required amount.
Also concurrent with the Preferred Stock Purchase Agreement, NuVasive, Progentix and the
Progentix Shareholders entered into an Option Purchase Agreement dated January 13, 2009, as amended
on December 30, 2009 (the Option Agreement), whereby NuVasive may be obligated (the Put Option),
upon the achievement within a specified period of time of certain milestones by Progentix, to
purchase the remaining sixty percent (60%) of capital stock of Progentix from its shareholders for
an amount up to $45 million, payable in a combination of cash or NuVasive common stock, at
NuVasives sole discretion, subject to certain adjustments (the Remaining Shares).
8
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, within a specified time period, to make additional payments to the Progentix Shareholders,
excluding NuVasive, of up to an aggregate total of $25 million, payable in a combination of cash
and NuVasive common stock, at NuVasives sole discretion, subject to certain adjustments. NuVasive
also has the right under the Option Agreement, as amended, to purchase the Remaining Shares (the
Call Option) during a stated period of time of the Option Agreement (the Option Period) for an
amount up to $35 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 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 revised 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 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 is 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 June 30, 2010, 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 June 30,
2010, the Company concluded it is not probable that the milestones will be met and that the
Remaining Shares will therefore become redeemable. The probability of redemption is reevaluated at
each reporting period.
Total assets and liabilities of Progentix as of June 30, 2010 included in the accompanying
consolidated balance sheet are as follows (in thousands):
|
|
|
|
|
Total current assets |
|
$ |
464 |
|
Identifiable intangible assets, net |
|
|
16,075 |
|
Goodwill |
|
|
12,654 |
|
Accounts payable & accrued expenses |
|
|
295 |
|
Other long-term liabilities |
|
|
188 |
|
Deferred tax liabilities |
|
|
3,338 |
|
Noncontrolling interests |
|
|
12,714 |
|
9
5. Balance Sheet Reserves
The balances of the reserves for accounts receivable and inventory are as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
2010 |
|
2009 |
Reserves for accounts receivable and sales returns |
|
$ |
3,192 |
|
|
$ |
4,163 |
|
Reserves for excess and obsolete inventory |
|
|
5,151 |
|
|
|
5,075 |
|
The Companys inventory consists primarily of finished goods, disposables and specialized
implants. Inventory is stated at the lower of cost or market and is recorded in cost of goods sold
based on a method that approximates cost. 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.
6. Marketable Securities and Fair Value Measurements
Marketable securities consist of corporate debt securities, U.S. government treasury
securities and 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 (loss) 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 operations. 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 operation. Interest and dividends on securities
classified as available-for-sale are included in interest income on the consolidated statements of
operations.
The composition of marketable securities is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contractual |
|
|
|
|
|
Gross |
|
Gross |
|
|
|
|
Maturity |
|
Amortized |
|
Unrealized |
|
Unrealized |
|
|
|
|
(in Years) |
|
Cost |
|
Gains |
|
Losses |
|
Fair Value |
|
|
|
|
|
|
|
June 30, 2010: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Classified as current assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government treasury securities |
|
Less than 1 |
|
$ |
29,023 |
|
|
$ |
21 |
|
|
$ |
|
|
|
$ |
29,044 |
|
Securities of government-sponsored entities |
|
Less than 1 |
|
|
73,934 |
|
|
|
49 |
|
|
|
(2 |
) |
|
|
73,981 |
|
Certificates of deposit |
|
Less than 1 |
|
|
2,311 |
|
|
|
1 |
|
|
|
(4 |
) |
|
|
2,308 |
|
Corporate notes |
|
Less than 1 |
|
|
6,332 |
|
|
|
2 |
|
|
|
(1 |
) |
|
|
6,333 |
|
|
|
|
|
|
|
|
Short-term marketable securities |
|
|
|
|
|
|
111,600 |
|
|
|
73 |
|
|
|
(7 |
) |
|
|
111,666 |
|
Classified as non-current assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Securities of government-sponsored entities |
|
|
1 to 2 |
|
|
|
34,009 |
|
|
|
39 |
|
|
|
(2 |
) |
|
|
34,046 |
|
|
|
|
|
|
|
|
Total marketable securities at June 30, 2010 |
|
|
|
|
|
$ |
145,609 |
|
|
$ |
112 |
|
|
$ |
(9 |
) |
|
$ |
145,712 |
|
|
|
|
|
|
|
|
10
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contractual |
|
|
|
|
|
Gross |
|
Gross |
|
|
|
|
Maturity |
|
|
|
|
|
Unrealized |
|
Unrealized |
|
|
|
|
(in Years) |
|
Cost |
|
Gains |
|
Losses |
|
Fair Value |
|
|
|
|
|
|
|
December 31, 2009: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Classified as current assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Certificates of deposit |
|
Less than 1 |
|
$ |
1,979 |
|
|
$ |
|
|
|
$ |
(6 |
) |
|
$ |
1,973 |
|
Corporate notes |
|
Less than 1 |
|
|
4,955 |
|
|
|
4 |
|
|
|
|
|
|
|
4,959 |
|
U.S. government treasury securities |
|
Less than 1 |
|
|
27,963 |
|
|
|
24 |
|
|
|
(4 |
) |
|
|
27,983 |
|
Securities of government-sponsored entities |
|
Less than 1 |
|
|
64,317 |
|
|
|
67 |
|
|
|
(20 |
) |
|
|
64,364 |
|
|
|
|
|
|
|
|
Short-term marketable securities |
|
|
|
|
|
|
99,214 |
|
|
|
95 |
|
|
|
(30 |
) |
|
|
99,279 |
|
Classified as non-current assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Securities of government-sponsored entities |
|
|
1 to 2 |
|
|
|
40,026 |
|
|
|
8 |
|
|
|
(66 |
) |
|
|
39,968 |
|
|
|
|
|
|
|
|
Total marketable securities at December 31, 2009 |
|
|
|
|
|
$ |
139,240 |
|
|
$ |
103 |
|
|
$ |
(96 |
) |
|
$ |
139,247 |
|
|
|
|
|
|
|
|
As of June 30, 2010, the Company had no investments that were in a significant 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 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 hold 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, Level 2 and Level 3 of the fair
value measurement hierarchy during the six months ended June 30, 2010.
The fair values of the Companys assets and liabilities at June 30, 2010, 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: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government treasury securities |
|
$ |
29,044 |
|
|
$ |
29,044 |
|
|
$ |
|
|
|
$ |
|
|
Securities of government-sponsored entities |
|
|
108,027 |
|
|
|
108,027 |
|
|
|
|
|
|
|
|
|
Corporate notes |
|
|
6,333 |
|
|
|
6,333 |
|
|
|
|
|
|
|
|
|
Certificates of deposit |
|
|
2,308 |
|
|
|
2,308 |
|
|
|
|
|
|
|
|
|
|
|
|
Total marketable securities at June 30, 2010 |
|
$ |
145,712 |
|
|
$ |
145,712 |
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent Consideration: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term acquisition related liabilities |
|
$ |
(30,876 |
) |
|
$ |
|
|
|
$ |
|
|
|
$ |
(30,876 |
) |
|
|
|
11
Contingent Consideration
In connection with the acquisition of 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 (FDA) 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 $30.9 million at June 30, 2010, resulting in a charge to sales,
marketing and administrative expense during the three and six months ended June 30, 2010 totaling
$0.2 million.
7. Convertible Senior Notes
In March 2008, the Company issued $230.0 million principal amount of 2.25% Convertible Senior
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 June 30, 2010
is approximately $245.0 million.
The Notes are convertible into shares of the Companys common stock, $0.001 par value per
share, 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), subject to adjustment, at an initial strike price of $49.13 per share.
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. 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 (Loss) Per Share
Basic net income (loss) per share (EPS) is calculated by dividing the net income (loss) by the
weighted average number of common shares outstanding for the period, without consideration for
common stock equivalents. Diluted EPS is computed by dividing net income (loss) by the weighted
average number of common shares outstanding for the period and the weighted average number of
dilutive common stock equivalents, such as the assumed vesting of outstanding unvested restricted
stock units, options, and warrants. Common stock equivalents are only included in the calculation
of diluted earnings per share when their effect is dilutive.
12
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
(in thousands, except per share amounts) |
|
2010 |
|
2009 |
|
2010 |
|
2009 |
|
|
|
|
|
Numerator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) attributable to NuVasive, Inc. |
|
$ |
6,723 |
|
|
$ |
2,765 |
|
|
$ |
7,811 |
|
|
$ |
(1,537 |
) |
|
|
|
|
|
Denominator for basic and diluted net loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding for basic |
|
|
39,242 |
|
|
|
36,910 |
|
|
|
39,071 |
|
|
|
36,639 |
|
Dilutive potential common stock outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options, ESPP and restricted stock units |
|
|
1,452 |
|
|
|
1,391 |
|
|
|
1,312 |
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding for diluted |
|
|
40,694 |
|
|
|
38,301 |
|
|
|
40,383 |
|
|
|
36,639 |
|
|
|
|
|
|
Basic net income (loss) per share attributable to NuVasive, Inc. |
|
$ |
0.17 |
|
|
$ |
0.07 |
|
|
$ |
0.20 |
|
|
$ |
(0.04 |
) |
|
|
|
|
|
Diluted net income (loss) per share attributable to NuVasive, Inc. |
|
$ |
0.17 |
|
|
$ |
0.07 |
|
|
$ |
0.19 |
|
|
$ |
(0.04 |
) |
|
|
|
|
|
The following outstanding common stock equivalents were not included in the calculation of net
income (loss) per diluted share because their effects were anti-dilutive:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
(in thousands) |
|
2010 |
|
2009 |
|
2010 |
|
2009 |
|
|
|
|
|
Weighted stock options and RSUs |
|
|
1,483 |
|
|
|
3,130 |
|
|
|
2,885 |
|
|
|
3,112 |
|
Warrants |
|
|
5,141 |
|
|
|
5,141 |
|
|
|
5,141 |
|
|
|
5,141 |
|
Convertible senior notes |
|
|
5,141 |
|
|
|
5,141 |
|
|
|
5,141 |
|
|
|
5,141 |
|
|
|
|
|
|
Total |
|
|
11,765 |
|
|
|
13,412 |
|
|
|
13,167 |
|
|
|
13,394 |
|
|
|
|
|
|
9. Comprehensive Income (Loss)
The components of comprehensive income (loss) are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2010 |
|
2009 |
|
2010 |
|
2009 |
|
|
|
Consolidated net income (loss) |
|
$ |
6,190 |
|
|
$ |
2,312 |
|
|
$ |
6,896 |
|
|
$ |
(2,220 |
) |
Other comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) on investments |
|
|
108 |
|
|
|
(27 |
) |
|
|
95 |
|
|
|
(299 |
) |
Translation adjustments |
|
|
(665 |
) |
|
|
665 |
|
|
|
(1,071 |
) |
|
|
462 |
|
|
|
|
Total consolidated comprehensive income (loss) |
|
|
5,633 |
|
|
|
2,950 |
|
|
|
5,920 |
|
|
|
(2,057 |
) |
Plus: Net loss attributable to noncontrolling interests |
|
|
(533 |
) |
|
|
(453 |
) |
|
|
(915 |
) |
|
|
(683 |
) |
|
|
|
Comprehensive income (loss) attributable to NuVasive, Inc. |
|
$ |
6,166 |
|
|
$ |
3,403 |
|
|
$ |
6,835 |
|
|
$ |
(1,374 |
) |
|
|
|
13
10. Stock-Based Compensation
The Company estimates the fair value of stock options granted to employees and shares issued
under the Employee Stock Purchase Plan, or ESPP Plan, using a Black-Scholes option-pricing model.
The weighted-average assumptions used to estimate the fair value of stock awards granted in the
three and six months ended June 30, 2010 and 2009 are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2010 |
|
2009 |
|
2010 |
|
2009 |
|
|
|
Stock Options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Volatility |
|
|
48 |
% |
|
|
47 |
% |
|
|
47 |
% |
|
|
45 |
% |
Expected term (years) |
|
|
4.5 |
|
|
|
3.4 |
|
|
|
4.5 |
|
|
|
4.3 |
|
Risk free interest rate |
|
|
2.0 |
% |
|
|
1.4 |
% |
|
|
2.4 |
% |
|
|
1.6 |
% |
Expected dividend yield |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
ESPP |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Volatility |
|
|
54 |
% |
|
|
47 |
% |
|
|
52 |
% |
|
|
46 |
% |
Expected term (years) |
|
|
1.3 |
|
|
|
1.6 |
|
|
|
1.3 |
|
|
|
1.4 |
|
Risk free interest rate |
|
|
0.9 |
% |
|
|
0.2 |
% |
|
|
0.9 |
% |
|
|
0.3 |
% |
Expected dividend yield |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
The compensation cost that has been included in the statement of operations for all
stock-based compensation arrangements was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
(in thousands) |
|
2010 |
|
2009 |
|
2010 |
|
2009 |
|
|
|
Sales, marketing and administrative expense |
|
$ |
6,672 |
|
|
$ |
5,243 |
|
|
$ |
12,352 |
|
|
$ |
10,484 |
|
Research and development expense |
|
|
877 |
|
|
|
1,074 |
|
|
|
1,631 |
|
|
|
2,515 |
|
|
|
|
Stock-based compensation expense |
|
$ |
7,549 |
|
|
$ |
6,317 |
|
|
$ |
13,983 |
|
|
$ |
12,999 |
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation for stock options and restricted stock units is recognized and
amortized on an accelerated basis in accordance with authoritative guidance issued by the FASB.
11. Income Taxes
The Company recorded income tax expense of $0.6 million and $0.5 million for the three months
ended June 30, 2010 and 2009, respectively, and $1.4 million and $0.6 million for the six months
ended June 30, 2010 and 2009, respectively. The effective income tax rate for the six months ended
June 30, 2010 was 17.2%, 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 2010 is expected to be lower than the U.S. federal statutory rate of 35% primarily due
to the availability of net operating loss carry forwards to offset 2010 taxable income.
At June 30, 2010, the Company continues to record a full valuation allowance against its
deferred tax assets, with limited exceptions for two foreign entities for which a valuation
allowance has not been required.
12. Legal Proceedings
UCLA Litigation
The Company has been involved in a series of related lawsuits involving families of decedents
who donated their bodies through UCLAs willed body program. The complaint alleges that the head of
UCLAs willed body program, Henry G. Reid, and a third party, Ernest V. Nelson, improperly sold
some of the donated cadavers to the defendants (including NuVasive). Plaintiffs alleged the
following causes of action: (i) breach of fiduciary duty; (ii) negligence; (iii) fraud; (iv)
negligent misrepresentation; (v) negligent infliction of emotional distress; (vi) intentional
infliction of emotional distress; (vii) intentional interference with human remains; (viii)
negligent interference with human remains; (ix) violation of California Business and Professions
Code Section 17200; and (x) injunctive and declaratory relief. The Company was dismissed from these
lawsuits by the trial court. After a series of appeals
14
regarding this dismissal, the California Court of Appeals affirmed the Companys dismissal on
April 7, 2010. The California Supreme Court recently denied Plaintiffs petition for review. As a
result, the Company is fully dismissed from the lawsuits and no further appeals of this decision
are possible.
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. Based on the granting of two reexamination requests
filed by Medtronic, the Court has stayed two of NuVasives three asserted patents, leaving three
Medtronic patents and one NuVasive patent in the first phase. The Court issued its claim
interpretation order interpreting the patents in the first phase on April 1, 2010, in which
NuVasive prevailed on several important disputes thereby improving NuVasives position with regard
to the asserted Medtronic patents and as to the asserted NuVasive patent. The first phase of the
case is presently in a discovery phase, and a trial on the four patents in the first phase is
scheduled to commence on May 10, 2011. NuVasive believes its own claims have merit and that
Medtronics claims lack merit. As of June 30, 2010, the probability of a favorable outcome cannot
be reasonably determined, nor can the Company reasonably estimate a potential loss, therefore, 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 is seeking cancellation of NuVasives
NeuroVision trademark registrations, injunctive relief and damages based on NMPs valuation of
the NeuroVision mark. NuVasive intends to vigorously pursue defense of the claims, and on
November 23, 2009, denied the allegations in the NMPs complaint and filed a counterclaim against
NMP for unfair competition and declaratory relief. The case is pending in the United States
District Court, and the case is currently set for trial in September 2010. As of June 30, 2010, the
probability of a favorable outcome cannot be reasonably determined, nor can the Company reasonably
estimate a potential loss, therefore, in accordance with the authoritative guidance on the
evaluation of contingencies, the Company has not recorded an accrual related to this litigation.
15
|
|
|
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, 2009. We do not intend to update these forward looking statements to
reflect future events or circumstances.
Overview
We are a medical device company focused on the design, development and marketing of products
for the surgical treatment of spine disorders. Our currently-marketed product portfolio is focused
on applications for spine fusion surgery, a market estimated to exceed $5.1 billion in the United
States in 2010. 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. In the spine surgery market, our currently-marketed products are
primarily used to enable access to the spine and to perform restorative and fusion procedures. 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 to our
sales and marketing efforts, including training spine surgeons on our unique technology and
products. Currently, we are training approximately 400 to 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 combines four categories of our product offerings:
|
|
|
NeuroVision® a proprietary software-driven nerve avoidance system; |
|
|
|
MaXcess® a unique split-blade design retraction system providing enhanced surgical
access to the spine; |
|
|
|
Biologics includes our FormaGraft® and Osteocel® line of products; and |
|
|
|
Specialized implants includes our SpheRx® and Armada tm pedicle screw systems,
CoRoent® suite of implants, and several fixation systems. |
Our MAS platform, with the unique advantages provided by NeuroVision, 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
visibility and our NeuroVision system allows surgeons to avoid critical nerves. Certain insurance
providers have stated a policy of not providing reimbursement for the XLIF procedure. NuVasive
cannot offer definitive time frames nor final outcomes regarding reversal of the non-coverage
policies, as the process is dictated by third-party insurance providers. To date, we have not experienced lack of payment for our procedures. On February 26, 2010, Aetna and United
Healthcare changed their spinal surgery policy to include coverage for the eXtreme Lateral
Interbody Fusion, or XLIF procedure, a reversal from their previous policy that labeled XLIF as
experimental and investigational or unproven.
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 clinical 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 submitted a premarket approval (PMA) application for U.S. Food and Drug
Administration (FDA) approval for the PCM cervical disc system. Approval, if obtained, will further
strengthen our cervical product offering and will enable
16
us to continue our trend of increasing our market share. Our biologic offering includes
FormaGraft, a collagen synthetic product used to aid the fusion process, and Osteocel, an allograft
cellular matrix containing viable mesenchymal stem cells, or MSCs, to aid in spinal fusion.
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. Progentix is studying the development and exploitation of knowledge and
products in the field of bone defects and the recovery of bone tissue in general. Progentix seeks
to further extend its existing knowledge and patent position in the field of Osteoinductive Bone
Graft Material Technology.
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 in the near term. We loan our NeuroVision systems and surgical
instrument sets at no cost to surgeons and hospitals that purchase disposables and implants for use
in individual procedures; there are no minimum purchase requirements of disposables and implants
related to these loaned surgical instruments. In addition, we place NeuroVision, 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 a small number of MAS instrument sets, MaXcess devices, and
NeuroVision systems. To date, we have derived less than 5% of our total revenues from these sales.
Through June 30, 2010, 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
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 operations 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
expanding our international sales efforts with the focus on both European and Asian markets. We
expect our international sales force to be made up of a combination of distributors and direct
sales personnel.
Results of Operations
Revenue
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
(dollars in thousands) |
|
2010 |
|
2009 |
|
$ Change |
|
% Change |
Three months ended |
|
$ |
119,584 |
|
|
$ |
88,481 |
|
|
$ |
31,103 |
|
|
|
35.2 |
% |
Six months ended |
|
$ |
228,671 |
|
|
$ |
168,490 |
|
|
$ |
60,181 |
|
|
|
35.7 |
% |
For the six months ended June 30, 2010 compared to the same period in 2009,
the 35.7 %
increase in revenue is due primarily to continued market acceptance of our products within our MAS®
platform, which includes our NeuroVision®, implant, biologic and disposable offerings, as well as
an increase in market penetration in our international markets. For the three months ended June
30, 2010 compared to the same period in 2009, the 35.2 % increase in revenue is due to
substantially the same increases by product offerings as that observed in the six month period.
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. We expect revenue to continue to
increase, which can be attributed to the continued adoption of our XLIF procedure and deeper
penetration into existing accounts as our sales force executes on the strategy of selling the full
mix of our products.
17
Cost of Goods Sold, excluding amortization of purchased technology
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
(dollars in thousands) |
|
2010 |
|
2009 |
|
$ Change |
|
% Change |
Three months ended |
|
$ |
21,014 |
|
|
$ |
14,235 |
|
|
$ |
6,779 |
|
|
|
47.6 |
% |
% of revenue |
|
|
17.6 |
% |
|
|
16.1 |
% |
|
|
|
|
|
|
|
|
Six months ended |
|
$ |
40,457 |
|
|
$ |
27,234 |
|
|
$ |
13,223 |
|
|
|
48.6 |
% |
% of revenue |
|
|
17.7 |
% |
|
|
16.2 |
% |
|
|
|
|
|
|
|
|
Cost of goods sold consists of purchased goods, inventory-related costs and royalty expenses.
The increase in cost of goods sold as a percentage of revenue for the six months ended June
30, 2010 compared to the same period in 2009 resulted primarily from the greater contribution to
revenue from our lower margin biologic product line and international businesses. We expect cost of
goods sold, as a percentage of revenue, to be approximately 17.5% for the remainder of 2010.
Operating Expenses
Sales, Marketing and Administrative
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
(dollars in thousands) |
|
2010 |
|
2009 |
|
$ Change |
|
% Change |
Three months ended |
|
$ |
77,726 |
|
|
$ |
60,274 |
|
|
$ |
17,452 |
|
|
|
29.0 |
% |
% of revenue |
|
|
65.0 |
% |
|
|
68.1 |
% |
|
|
|
|
|
|
|
|
Six months ended |
|
$ |
152,387 |
|
|
$ |
120,801 |
|
|
$ |
31,586 |
|
|
|
26.1 |
% |
% of revenue |
|
|
66.6 |
% |
|
|
71.7 |
% |
|
|
|
|
|
|
|
|
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 loaned instrument sets used in surgeries;
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 fluctuate with sales
and expenses associated with investments in our infrastructure and headcount growth. As a
percentage of revenue, sales, marketing and administrative expenses decreased for the three and six
months ended June 30, 2010 compared to the same periods in 2009 principally from operating leverage
in our expenses relative to the 35.2% and 35.7% growth in revenue for the three and six months
ended June 30, 2010, respectively.
Costs based on revenue, such as sales force compensation and other direct costs related to the
sales force, shipping costs and depreciation expense related to our surgical instrument sets
increased $11.6 million and $23.2 million for the three and six months ended June 30, 2010,
respectively, compared to the same periods in 2009. The increases are reasonably consistent with
our increased revenue growth for the three and six months ended June 30, 2010 as compared to the
same periods in 2009. Total costs related to our sales force, as a percent of revenue, decreased to
29.0% from 29.8% for the three months ended June 30, 2010 compared to the same period in 2009.
We also experienced increased costs as a result of overall Company growth and headcount
additions in our marketing and administrative support functions. Marketing and administrative
compensation and related costs increased $3.6 million and $5.9 million for the three and six months
ended June 30, 2010, respectively, compared to the same periods in 2009. Stock-based compensation
increased $1.4 million and $1.9 million in the three and six months ended June 30, 2010,
respectively, compared to the same periods in 2009 primarily related to an increase in stock-based
awards granted to shareowners (employees) associated with the continued increase in headcount.
These increases in expenses are partially offset by decreases of approximately $0.4 million and
$2.3 million in acquisition-related costs during the three and six months ended June 30, 2010,
respectively, compared to the same periods in 2009, attributable to expenses incurred in connection
with our investment in Progentix and acquisition of Cervitech in the three and six months ended
June 30, 2009 with no comparable expense during the same periods in 2010.
18
In addition to the items discussed above, legal expenses increased $1.8 million and $2.5
million for the three and six months ended June 30, 2010, respectively, compared to the same
periods in 2009, resulting primarily from increased non-Medtronic related litigation activity.
These increased expenses were partially offset by the recovery of an international receivable in
the amount of $0.5 million and $1.5 million in the three and six months ended June 30, 2010,
respectively, which had previously been reserved for in the first half of 2009.
On a long-term basis, as a percentage of revenue, we expect total sales, marketing and
administrative costs to continue to decrease over time as we continue to see the leverage driven by
continued revenue growth.
Research and Development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
(dollars in thousands) |
|
2010 |
|
2009 |
|
$ Change |
|
% Change |
Three months ended |
|
$ |
11,205 |
|
|
$ |
8,178 |
|
|
$ |
3,027 |
|
|
|
37.0 |
% |
% of revenue |
|
|
9.4 |
% |
|
|
9.2 |
% |
|
|
|
|
|
|
|
|
Six months ended |
|
$ |
21,904 |
|
|
$ |
16,764 |
|
|
$ |
5,140 |
|
|
|
30.7 |
% |
% of revenue |
|
|
9.6 |
% |
|
|
9.9 |
% |
|
|
|
|
|
|
|
|
Research and development expense consists primarily of product research and development,
clinical trial and study costs, regulatory and clinical functions, and shareowner (employee)
related expenses.
Expenses related to ongoing clinical trial and study related activities designed to
demonstrate the value of our emerging and existing technologies increased $1.3 million and $2.4
million for the three and six months ended June 30, 2010, respectively, compared to the same
periods in 2009. In addition, compensation and other shareowner related expenses increased $0.9
million and $1.5 million for the three and six months ended June 30, 2010, respectively, primarily
due to increased headcount to support our product development and enhancement efforts. In addition,
expenses increased $0.4 million and $0.8 million during the three and six months ended June 30,
2010, respectively, as compared to 2009 as a result of expenses incurred in connection with a
supply agreement related to the bone graft product being developed by Progentix. We expect research
and development costs to continue to increase in absolute dollars for the foreseeable future in
support of our ongoing development and planned clinical trial and study related activities.
Amortization of Intangible Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
(dollars in thousands) |
|
2010 |
|
2009 |
|
$ Change |
|
% Change |
Three months ended: |
|
$ |
1,355 |
|
|
$ |
1,372 |
|
|
$ |
(17 |
) |
|
|
(1.2 |
%) |
% of total revenue |
|
|
1.1 |
% |
|
|
1.6 |
% |
|
|
|
|
|
|
|
|
Six months ended: |
|
$ |
2,705 |
|
|
$ |
2,708 |
|
|
$ |
(3 |
) |
|
|
(0.1 |
%) |
% of total revenue |
|
|
1.2 |
% |
|
|
1.6 |
% |
|
|
|
|
|
|
|
|
Amortization of intangible assets relates to amortization of finite-lived intangible assets
acquired. Although amortization expense for the three and six months ended June 30, 2010 compared
to the same periods in 2009 remained relatively constant, we expect expenses recorded in connection
with the amortization of intangible assets 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 Income, Net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
(dollars in thousands) |
|
2010 |
|
2009 |
|
$ Change |
|
% Change |
Three months ended: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
$ |
178 |
|
|
$ |
383 |
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
(1,668 |
) |
|
|
(2,060 |
) |
|
|
|
|
|
|
|
|
Other income (expense), net |
|
|
(30 |
) |
|
|
93 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total interest and other income (expense), net |
|
$ |
(1,520 |
) |
|
$ |
(1,584 |
) |
|
$ |
64 |
|
|
|
4.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
% of revenue |
|
|
1.3 |
% |
|
|
1.8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six months ended: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
$ |
367 |
|
|
$ |
1,115 |
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
(3,337 |
) |
|
|
(3,830 |
) |
|
|
|
|
|
|
|
|
Other income, net |
|
|
87 |
|
|
|
135 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total interest and other income (expense), net |
|
$ |
(2,883 |
) |
|
$ |
(2,580 |
) |
|
$ |
(303 |
) |
|
|
(11.7 |
%) |
|
|
|
|
|
|
|
|
|
|
|
% of revenue |
|
|
1.3 |
% |
|
|
1.5 |
% |
|
|
|
|
|
|
|
|
Interest and other income (expense), net, consists primarily of interest income earned on
marketable securities offset by interest expense incurred related to the Companys outstanding
convertible senior notes. The net change in interest and other income (expense), net, in the
periods presented is principally due to a decrease of $0.2 million and $0.7 million in interest
income earned in the three and six months ended June 30, 2010, respectively, resulting principally
from lower interest rates in 2010 as compared to the same periods in 2009.
Income Tax Expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
(dollars in thousands) |
|
2010 |
|
2009 |
|
$ Change |
|
% Change |
Three months ended: |
|
$ |
574 |
|
|
$ |
526 |
|
|
$ |
48 |
|
|
|
9.1 |
% |
% of total revenue |
|
|
0.5 |
% |
|
|
0.6 |
% |
|
|
|
|
|
|
|
|
Six months ended: |
|
$ |
1,439 |
|
|
$ |
623 |
|
|
$ |
816 |
|
|
|
131.0 |
% |
% of total revenue |
|
|
0.6 |
% |
|
|
0.4 |
% |
|
|
|
|
|
|
|
|
Our effective income tax rate will fluctuate from period to period due to several factors
including the operating results of our international operations. We update our annual effective
income tax rate each quarter and if the estimated effective income tax rate changes, a cumulative
adjustment is made. The effective income tax rate for the six months ended June 30, 2010 was
17.2%, which is based on an estimate of the Companys annual effective income tax rate, and is
lower than the U.S. federal statutory rate of 35% primarily due to the availability of net
operating loss carry forwards to offset 2010 taxable income.
Stock-Based Compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
|
|
(dollars in thousands) |
|
2010 |
|
|
2009 |
|
|
$ Change |
|
|
% Change |
|
Three months ended: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales, marketing and administrative expense |
|
$ |
6,672 |
|
|
$ |
5,243 |
|
|
|
|
|
|
|
|
|
Research and development expense |
|
|
877 |
|
|
|
1,074 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stock-based compensation expense |
|
$ |
7,549 |
|
|
$ |
6,317 |
|
|
$ |
1,232 |
|
|
|
19.5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of revenue |
|
|
6.3 |
% |
|
|
7.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six months ended: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales, marketing and administrative expense |
|
$ |
12,352 |
|
|
$ |
10,484 |
|
|
|
|
|
|
|
|
|
Research and development expense |
|
|
1,631 |
|
|
|
2,515 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stock-based compensation expense |
|
$ |
13,983 |
|
|
$ |
12,999 |
|
|
$ |
984 |
|
|
|
7.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of revenue |
|
|
6.1 |
% |
|
|
7.7 |
% |
|
|
|
|
|
|
|
|
20
We recognize stock-based compensation expense on an accelerated basis in accordance with
authoritative guidance, which effectively results in the recognition of approximately 60% of the
total compensation expense for a particular equity award within 12 months of its grant date. The
increase in stock-based compensation in the periods presented is primarily related to an increase
in stock-based awards granted to shareowners associated with the continued increase in headcount.
Liquidity, Cash Flows and Capital Resources
Since our inception in 1997, we have incurred significant losses and as of June 30, 2010, we
had an accumulated deficit of approximately $181.9 million. To date, our operations have been
funded primarily with proceeds from the sale of our securities. However, as a result of increased
sales and profitability, we have begun to generate cash flows from operations, which will be used
to finance our operating and capital expenditures.
In March 2008, we issued $230.0 million principal amount of 2.25% Convertible Senior 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.
Cash, cash equivalents and short-term and long-term marketable securities, was $213.2 million
at June 30, 2010 and $204.7 million at December 31, 2009.
Cash Flows
The following table summarizes, for the periods indicated, selected items in our consolidated
statements of cash flows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
|
June 30, |
|
|
(dollars in thousands) |
|
2010 |
|
2009 |
|
$ Change |
Cash provided by operating activities |
|
$ |
25,461 |
|
|
$ |
7,566 |
|
|
$ |
17,895 |
|
Cash used in investing activities |
|
|
(29,046 |
) |
|
|
(9,903 |
) |
|
|
(19,143 |
) |
Cash provided by financing activities |
|
|
5,851 |
|
|
|
6,297 |
|
|
|
(446 |
) |
Effect of exchange rate changes on cash |
|
|
(166 |
) |
|
|
48 |
|
|
|
(214 |
) |
|
|
|
Increase in cash and cash equivalents |
|
$ |
2,100 |
|
|
$ |
4,008 |
|
|
$ |
(1,908 |
) |
|
|
|
Cash flows from operating activities
Cash provided by operating activities was $25.5 million for the six months ended June 30,
2010, compared to $7.6 million for the same period in 2009. The $17.9 million increase in cash
provided by operating activities in the six months ended June 30, 2010 as compared to the same
period in 2009 is primarily due to improvement in our profitability profile, an increase in
non-cash depreciation and amortization expense and improvement in our working capital where tighter
inventory management more than offset the growth in accounts receivable caused by our continually
growing revenue base.
Cash flows used in investing activities
Cash used in investing activities was $29.0 million for the six months ended June 30, 2010,
compared to $9.9 million for the same period in 2009. The $19.1 million increase in cash used in
investing activities in the six months ended June 30, 2010 as compared to the same period in 2009
is primarily due to increased investing in available-for-sale securities, as well as increased purchases of surgical
instrument sets, which are deployed to support our increasing revenue volume, and increased
expenditures in infrastructure related to the addition of our New York facility and expansion of
our Memphis facility. These increases in spending were offset by a decrease in cash used for
acquisitions and investments in 2010 compared to 2009 as the acquisition of Cervitech, Inc. and our
investment in Progentix were completed in 2009 with no comparable investments in 2010.
21
Cash flows from financing activities
Cash provided by financing activities was $5.9 million for the six months ended June 30, 2010,
compared to $6.3 million for the same period in 2009. The $0.4 million decrease in cash provided by
financing activities for the six months ended June 30, 2010 as compared to the same period in 2009
is primarily due to increased proceeds from stock option exercises and purchases made through our
Employee Stock Purchase Plan, partially offset by an increase in cash used for long-term other
assets (primarily cash used as collateral for letters of credit).
Liquidity
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.
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 and marketing
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.
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 to bad debts, inventories, valuation of goodwill, intangibles and other
long-term assets, income taxes, and stock-based compensation. 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, 2009 and there have been no material changes
during the six months ended June 30, 2010.
New accounting requirements
Effective January 1, 2010, we adopted a newly issued accounting standard which provides
guidance for the consolidation of variable interest entities and requires an enterprise to
determine whether its variable interest or interests give it a controlling financial interest in a
variable interest entity. This amended consolidation guidance for variable interest entities
replaces the existing quantitative approach for identifying which enterprise should consolidate a
variable interest entity, which was based on which enterprise is exposed to a majority of the risks
and rewards, with a qualitative approach, based on which enterprise has both (1) the power to
direct the economically significant activities of the entity and (2) the obligation to absorb
losses of, or the right to receive benefits from, the entity that could potentially be significant
to the variable interest entity. The adoption of this standard did not have an impact on our
financial position or results of operations. Determination about whether an enterprise should
consolidate a variable interest entity is required to be evaluated continuously as changes to
existing relationships or future transactions may result in our consolidating or deconsolidating
current or future business arrangements.
Off-Balance Sheet Arrangements
We have not engaged in any off-balance sheet activities.
|
|
|
Item 3. |
|
Quantitative and Qualitative Disclosures About Market Risk |
Our exposure to interest rate risk at June 30, 2010 is related to our investment portfolio
which consists principally of debt securities of the U.S. government and U.S government-sponsored
entities. Due to the short-term nature of these investments, we have
22
assessed that there is no material exposure to interest rate risk arising from our
investments. Fixed rate investments and borrowings may have their fair market value adversely
impacted from changes in interest rates.
Interest Rate Risk. Our exposure to market risk for changes in interest rates relates
primarily to our investment portfolio. The fair market value of fixed rate securities may be
adversely impacted by fluctuations in interest rates while income earned on floating rate
securities may decline as a result of decreases in interest rates. Under our current policies, we
do not use interest rate derivative instruments to manage exposure to interest rate changes. We
attempt to ensure the safety and preservation of our invested principal funds by limiting default
risk, market risk and reinvestment risk. We mitigate default risk by investing in investment grade
securities. We have historically maintained a relatively short average maturity for our investment
portfolio, and we believe a hypothetical 10% adverse move in interest rates along the entire
interest rate yield curve would not materially affect the fair value of our interest sensitive
financial instruments.
Foreign Currency Exchange and Market Risk. To date, we have operated mainly in the United
States of America, and the majority of our sales since inception have been made in U.S. dollars.
Prior to 2009, a majority of our sales to international markets were to independent distributors in
transactions conducted in U.S. dollars. Beginning in 2009, our sales in international markets,
primarily Puerto Rico, the United Kingdom, Germany and Australia, are through local subsidiaries
which sell directly to health care providers in local currencies. As a portion of our operations
consists of activities outside of the United States in local currencies we have foreign exchange
exposures to non-U.S.dollar revenues, operating expenses, accounts receivable, accounts payable and
currency bank balances. In addition, our international operations are subject to risks typical of
international operations, including, but not limited to, differing economic conditions, changes in
political climate, differing tax structures, other regulations and restrictions, and foreign
exchange rate volatility. There have been no significant changes in our exposure to market risk
during the six months ended June 30, 2010, and to date, we have not had any material exposure to
foreign currency rate fluctuations.
|
|
|
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 recognizes 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 is 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 June 30, 2010. Based on such evaluation, our
management has concluded that as of June 30, 2010, 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, 2009, except as follows:
We have been involved in a series of related lawsuits involving families of decedents who
donated their bodies through UCLAs willed body program. The complaint alleges that the head of
UCLAs willed body program, Henry G. Reid, and a third party, Ernest V. Nelson, improperly sold
some of the donated cadavers to the defendants (including NuVasive). Plaintiffs allege the
following causes of action: (i) breach of fiduciary duty; (ii) negligence; (iii) fraud; (iv)
negligent misrepresentation; (v) negligent infliction of
23
emotional distress; (vi) intentional infliction of emotional distress; (vii) intentional
interference with human remains; (viii) negligent interference with human remains; (ix) violation
of California Business and Professions Code Section 17200; and (x) injunctive and declaratory
relief. We were dismissed from these lawsuits by the trial court. After a series of appeals
regarding this dismissal, the California Court of Appeals affirmed our dismissal on April 7, 2010.
As a result, we are fully dismissed from these lawsuits and no further appeals of this decision are
possible.
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. In its current form, the lawsuit
alleges that certain of NuVasives products or methods, including the XLIF procedure, infringe, or
contribute to the infringement of, nine U.S. patents: 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.
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 selected by the
asserting party that are not the subject of active reexamination proceedings. As a result, the
initial phase of the case includes three Medtronic patents (5,860,973; 6,945,933; and 6,592,586)
and one NuVasive patent (7,470,236). The Court, in an order dated April 1, 2010, provided a
Markman Order, setting forth its interpretation of the asserted claims of the patents included in
the initial phase of the case. This initial phase of the case remains in a discovery phase. A trial
on the initial phase of the case is scheduled to commence in mid 2011.
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, 2009
(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.
|
|
|
Item 5. |
|
Other Information |
On June 6, 2010, Patrick Miles, our President of the Americas, adopted a stock trading plan
for trading in NuVasives common stock, currently held or issuable upon the exercise of stock
options, in accordance with the guidelines specified by the Securities and Exchange Commissions
Rule 10b5-1 under the Securities Exchange Act of 1934. Mr. Miles will file Forms 4 evidencing any
such sales under his stock trading plan as required under Section 16 of the Securities Exchange Act
of 1934. This type of trading plan allows a corporate insider to gradually diversify holdings of
company stock while minimizing any market effects of such trades by spreading them out over an
extended period of time and eliminating any market concern that such trades were made by a person
while in possession of material nonpublic information. Consistent with Rule 10b5-1, NuVasives
insider trading policy permits personnel to implement Rule 10b5-1 trading plans provided that,
among other things, such personnel are not in possession of any material nonpublic information at
the time they adopt such plans.
Pursuant to the stock trading plan adopted by Mr. Miles, between September 2010 and November
2010, he will sell 5,000 shares if the stock is above a prearranged minimum price, and may sell up
to 10,000 additional shares based on increasing price levels; between
24
December 2010 and February 2011 he will sell 2,500 shares each month if the stock is above a
prearranged minimum price, and may sell up to 5,000 additional shares each month based on
increasing price levels.
25
EXHIBIT INDEX
|
|
|
Exhibit No |
|
Description |
|
|
|
3.1 (1)
|
|
Restated Certificate of Incorporation |
|
|
|
3.2 (2)
|
|
Restated Bylaws |
|
|
|
31.1
|
|
Certification of Chief Executive Officer pursuant to Rules
13a-14 and 15d-14 promulgated under the Securities Exchange
Act of 1934 |
|
|
|
31.2
|
|
Certification of Chief Financial Officer pursuant to Rules
13a-14 and 15d-14 promulgated under the Securities Exchange
Act of 1934 |
|
|
|
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 |
|
|
|
(1) |
|
Incorporated by reference to our Quarterly Report on Form 10-Q filed with the Commission on
August 13, 2004. |
|
(2) |
|
Incorporated by reference to our Current Report on Form 8-K filed with the Commission on
December 15, 2008. |
|
* |
|
These certifications are being furnished solely to accompany this quarterly 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. |
26
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: August 6, 2010
|
|
|
|
|
|
|
|
|
By: |
/s/ Alexis V. Lukianov
|
|
|
|
Alexis V. Lukianov |
|
|
|
Chairman and Chief Executive Officer |
|
Date: August 6, 2010
|
|
|
|
|
|
|
|
|
|
By: |
/s/ Michael J. Lambert
|
|
|
|
Michael J. Lambert |
|
|
|
Executive Vice President and Chief Financial Officer |
|
|
27
EXHIBIT INDEX
|
|
|
Exhibit No |
|
Description |
|
|
|
3.1 (1)
|
|
Restated Certificate of Incorporation |
|
|
|
3.2 (2)
|
|
Restated Bylaws |
|
|
|
31.1
|
|
Certification of Chief Executive Officer pursuant to Rules
13a-14 and 15d-14 promulgated under the Securities Exchange
Act of 1934 |
|
|
|
31.2
|
|
Certification of Chief Financial Officer pursuant to Rules
13a-14 and 15d-14 promulgated under the Securities Exchange
Act of 1934 |
|
|
|
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 |
|
|
|
(1) |
|
Incorporated by reference to our Quarterly Report on Form 10-Q filed with the Commission on
August 13, 2004. |
|
(2) |
|
Incorporated by reference to our Current Report on Form 8-K filed with the Commission on
December 15, 2008. |
|
* |
|
These certifications are being furnished solely to accompany this quarterly 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. |
28