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 September 30, 2009
OR
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number 000-50744
NUVASIVE, INC.
(Exact name of registrant as specified in its charter)
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Delaware
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33-0768598 |
(State or other jurisdiction of
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(I.R.S. Employer |
incorporation or organization)
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Identification No.) |
7475 Lusk Boulevard
San Diego, CA 92121
(Address of principal executive offices, including zip code)
(858) 909-1800
(Registrants telephone number, including area code)
(Former name, former address and former fiscal year, if changed since last report)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.
Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate 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 o 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 | |
Accelerated filer o | |
Non-accelerated filer o | |
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 October 30, 2009, there were 38,218,153 shares of the registrants common stock outstanding.
NUVASIVE, INC.
QUARTERLY REPORT ON FORM 10-Q
September 30, 2009
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)
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September 30, |
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December 31, |
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2009 |
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2008 |
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(unaudited) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
134,276 |
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$ |
132,318 |
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Short-term marketable securities |
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55,915 |
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45,738 |
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Accounts receivable, net |
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51,245 |
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51,622 |
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Inventory |
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85,892 |
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68,834 |
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Prepaid expenses and other current assets |
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3,925 |
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3,466 |
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Total current assets |
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331,253 |
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301,978 |
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Property and equipment, net |
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77,543 |
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73,686 |
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Long-term marketable securities |
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10,032 |
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45,305 |
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Goodwill |
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102,264 |
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2,332 |
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Intangible assets, net |
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104,601 |
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54,767 |
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Other assets |
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7,337 |
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9,338 |
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Total assets |
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$ |
633,030 |
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$ |
487,406 |
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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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$ |
23,183 |
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$ |
26,633 |
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Accrued payroll and related expenses |
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20,568 |
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17,132 |
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Acquisition related liabilities |
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15,414 |
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Royalties payable |
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2,201 |
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1,722 |
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Total current liabilities |
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61,366 |
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45,487 |
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Senior convertible notes |
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230,000 |
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230,000 |
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Long-term acquisition related liabilities |
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30,318 |
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12,111 |
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Other long-term liabilities |
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29,099 |
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12,177 |
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Commitments and contingencies |
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Noncontrolling interests |
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13,689 |
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Stockholders equity: |
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Common stock, $0.001 par value; 70,000
shares authorized, 38,184 and 36,310 issued
and outstanding at September 30, 2009 and
December 31, 2008, respectively |
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38 |
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36 |
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Additional paid-in capital |
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460,290 |
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383,293 |
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Accumulated other comprehensive income (loss) |
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211 |
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(190 |
) |
Accumulated deficit |
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(191,981 |
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(195,508 |
) |
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Total stockholders equity |
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268,558 |
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187,631 |
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Total liabilities and stockholders equity |
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$ |
633,030 |
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$ |
487,406 |
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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)
(unaudited)
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Three Months Ended |
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Nine Months Ended |
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September 30, |
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September 30, |
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2009 |
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2008 |
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2009 |
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2008 |
Revenues |
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$ |
94,916 |
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$ |
66,915 |
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$ |
263,405 |
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$ |
175,501 |
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Cost of goods sold |
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18,417 |
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12,195 |
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49,901 |
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30,845 |
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Gross profit |
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76,499 |
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54,720 |
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213,504 |
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144,656 |
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Operating expenses: |
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Sales, marketing and administrative |
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59,761 |
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54,557 |
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176,391 |
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135,975 |
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Research and development |
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10,654 |
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6,396 |
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30,047 |
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19,797 |
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In-process research and development |
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16,700 |
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20,876 |
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Total operating expenses |
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70,415 |
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77,653 |
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206,438 |
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176,648 |
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Interest income |
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203 |
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1,460 |
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1,318 |
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4,373 |
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Interest expense |
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(1,609 |
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(1,719 |
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(5,439 |
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(3,816 |
) |
Other income (expense), net |
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(242 |
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113 |
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(729 |
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207 |
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Total interest and other income (expense), net |
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(1,648 |
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(146 |
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(4,850 |
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764 |
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Consolidated net income (loss) |
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$ |
4,436 |
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$ |
(23,079 |
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$ |
2,216 |
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$ |
(31,228 |
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Net loss attributable to noncontrolling interests |
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$ |
(628 |
) |
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$ |
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$ |
(1,311 |
) |
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$ |
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Net income (loss) attributable to NuVasive, Inc. |
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$ |
5,064 |
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$ |
(23,079 |
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$ |
3,527 |
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$ |
(31,228 |
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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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$ |
0.13 |
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$ |
(0.64 |
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$ |
0.10 |
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$ |
(0.88 |
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Diluted net income (loss) per share |
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$ |
0.13 |
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$ |
(0.64 |
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$ |
0.09 |
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$ |
(0.88 |
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Weighted average shares outstanding basic |
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37,733 |
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35,931 |
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37,008 |
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35,674 |
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Weighted average shares outstanding diluted |
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39,216 |
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35,931 |
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38,384 |
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35,674 |
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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)
(unaudited)
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Nine Months Ended September 30, |
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2009 |
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2008 |
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Operating activities: |
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Net income (loss) |
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$ |
3,527 |
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$ |
(31,228 |
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Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: |
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Depreciation and amortization |
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22,005 |
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15,671 |
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In-process research and development |
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20,876 |
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Stock-based compensation |
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18,165 |
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15,719 |
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Leasehold abandonment charges |
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(1,997 |
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4,486 |
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Noncontrolling interests |
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(1,311 |
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Allowance for excess and obsolete inventory |
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2,470 |
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(3 |
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Allowance for doubtful accounts |
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1,175 |
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410 |
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Other non-cash adjustments |
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2,248 |
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1,019 |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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(329 |
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(18,986 |
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Inventory |
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(19,027 |
) |
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(22,136 |
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Prepaid expenses and other current assets |
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788 |
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(941 |
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Accounts payable and accrued liabilities |
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2,410 |
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3,898 |
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Accrued payroll and related expenses |
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2,742 |
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1,778 |
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Net cash provided by (used in) operating activities |
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32,866 |
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(9,437 |
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Investing activities: |
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Cash paid for acquisitions (Note 3) |
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(24,055 |
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(41,256 |
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Cash paid for investment in Progentix (Note 3) |
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(10,000 |
) |
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Acquisition related milestone payments |
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(10,000 |
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Purchases of property and equipment |
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(21,250 |
) |
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(34,161 |
) |
Purchases of short-term marketable securities |
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(46,678 |
) |
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(83,069 |
) |
Sales of short-term marketable securities |
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56,365 |
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29,842 |
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Purchases of long-term marketable securities |
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(17,964 |
) |
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(51,390 |
) |
Sales of long-term marketable securities |
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32,971 |
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14,778 |
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Other assets |
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544 |
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Net cash used in investing activities |
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(40,611 |
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(164,712 |
) |
Financing activities: |
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Payments of long-term liabilities |
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(300 |
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Issuance of convertible debt, net of costs |
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222,414 |
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Purchase of convertible note hedges |
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(45,758 |
) |
Sale of warrants |
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31,786 |
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Issuance of common stock |
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9,618 |
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8,480 |
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Net cash provided by financing activities |
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9,618 |
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216,622 |
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Effect of exchange rate changes on cash |
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85 |
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Increase in cash and cash equivalents |
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1,958 |
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42,473 |
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Cash and cash equivalents at beginning of period |
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132,318 |
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61,915 |
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Cash and cash equivalents at end of period |
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$ |
134,276 |
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$ |
104,388 |
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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
NuVasive, Inc. (the Company or NuVasive) was incorporated in Delaware on July 21, 1997. The
Company is a medical device company focused on the design, development, and marketing of products
for the surgical treatment of spine disorders. The Companys product portfolio is focused primarily
on the U.S. spine implant market. Additionally, the Company has expanded into the global biologics
market, the international spine implant market, and is developing products for the emerging motion
preservation market.
NuVasives principal product offering is based on its Maximum Access Surgery, or MAS®
platform. The MAS platform combines four categories of products that collectively minimize soft
tissue disruption during spine surgery with maximum visualization and safe, easy reproducibility
for the surgeon: NeuroVision®, a proprietary software-driven nerve avoidance system; MaXcess®, a
unique split-blade retractor system; a wide variety of specialized implants; and several biologic
fusion enhancers. The MAS platform significantly reduces surgery time and returns patients to
activities of daily living much faster than conventional approaches. Utilizing the Companys MAS
platforms lateral approach, known as eXtreme Lateral Interbody Fusion, or XLIF®, the Company has
built an entire spine franchise. With products today spanning lumbar, thoracic and cervical
applications, the Company continues to expand and evolve its offering predicated on its research
and development focus and dedication to outstanding service levels supported by a culture of
Absolute Responsiveness®.
The Company loans its MAS systems to surgeons and hospitals that purchase implants and
disposables 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
provided they commit to minimum monthly purchases of disposables and implants. The Company sells a
small quantity of MAS instrument sets, MaXcess and NeuroVision systems to hospitals. The Company
also offers a range of allograft and spine implants such as rods, plates and screws. Implants and
disposables are shipped from the Companys facilities.
2. 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, 2008
and for the three and nine months ended September 30, 2008 include the accounts of the Company and
its wholly owned subsidiaries. The unaudited condensed consolidated financial statements as of
September 30, 2009 and for the three and nine months then ended 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). There has been no material activity by the Companys
subsidiaries during the periods presented. All significant intercompany accounts and transactions
have been eliminated in consolidation.
Management evaluated all events or transactions that occurred after September 30, 2009 up
through November 6, 2009, the date on which these financial statements were issued.
These financial statements should be read in conjunction with the audited consolidated
financial statements and notes thereto for the year ended December 31, 2008 included in NuVasives
Annual Report on Form 10-K filed with the Securities and Exchange Commission. Operating results for
the three and nine months ended September 30, 2009 and 2008 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, 2008 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.
6
3. Acquisitions and Investments
Cervitech® Inc. Acquisition
On May 8, 2009 (the Closing Date), the Company completed the purchase of all of the
outstanding shares of Cervitech, Inc., a Delaware corporation (Cervitech), pursuant to a Share
Purchase Agreement dated April 22, 2009 (the Purchase Agreement) for an initial payment of
approximately $48 million consisting of cash totaling approximately $24 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 above payment, the Company may be obligated to make an additional milestone
payment of $33 million if the U.S. Food and Drug Administration (FDA) issues an approval order
allowing the commercialization of Cervitechs PCM device in the United States with an intended use
for treatment of degenerative disc disease. The milestone payment may be made in cash or a
combination of cash and up to half in NuVasive common stock, at the Companys discretion.
Purchase Price
The acquisition of Cervitech was recorded using the acquisition method of accounting in
accordance with the revised authoritative guidance for business combinations.
The estimated purchase price is determined as follows (in thousands):
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Cash paid to sellers |
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$ |
24,055 |
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Market value of NuVasive common stock issued on Closing Date |
|
|
24,215 |
|
Contingent consideration liability, due on achieving FDA approval |
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|
29,722 |
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|
Total estimated purchase price |
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$ |
77,992 |
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|
The preliminary allocation of the estimated purchase price is based on managements
preliminary valuation of the fair value of tangible, intangible assets and in-process research and
development acquired and liabilities assumed as of the Closing Date and such estimates are subject
to revision. The area of the purchase price allocation that is not yet finalized relates primarily
to the valuation of income tax related assets acquired. Consequently, the amounts recorded at
September 30, 2009 are subject to change, and the final amounts may differ. The following table
summarizes the allocation of the estimated initial purchase price (in thousands):
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Estimated |
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Estimated Useful |
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Fair Value |
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Life |
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Total current assets |
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$ |
1,233 |
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Property, plant and equipment |
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59 |
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Developed technology |
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700 |
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|
14 years |
Non-compete agreement |
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100 |
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2 years |
Trade name |
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|
700 |
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|
10 years |
In-process research and development |
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|
34,800 |
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|
14 years |
Goodwill |
|
|
54,825 |
|
|
|
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Current liabilities |
|
|
(483 |
) |
|
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|
|
Deferred income tax liabilities |
|
|
(13,942 |
) |
|
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|
|
|
|
|
|
|
|
|
|
Total estimated initial purchase price allocation |
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$ |
77,992 |
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|
The Goodwill balance related to the Cervitech Acquisition was $54.8 million as of September
30, 2009. Goodwill represents the excess of the purchase price over the fair value of tangible and
identifiable intangible assets acquired. Of the $54.8 million recorded as goodwill, none is
expected to be deductible for tax purposes.
Contingent Consideration Liability
The arrangement requires the Company to pay an additional amount not to exceed $33 million in
the event that Cervitechs device receives FDA approval. 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. This fair value measurement is based on significant inputs not
observable in the market. The key assumptions in applying this approach were the interest rate and
the probability assigned to the milestone being
achieved. Management will remeasure the fair value of the contingent consideration at each
reporting period, with any change in its
7
fair value resulting from either the passage of time or
events occurring after the acquisition date, such as changes in the estimate of the probability of
achieving the milestone, being recorded in the current periods earnings. During the nine months
ended September 30, 2009, there were no changes in estimate to affect the fair value of the
contingent consideration liability other than accretion related solely to the passage of time. For
the three and nine months ended September 30, 2009, the Company recorded approximately $0.4 million
and $0.6 million, respectively, in expense to reflect the change in the fair value of the
contingent consideration and increasing the fair value of the contingent consideration liability to
$30.3 million at September 30, 2009. The $0.6 million change in fair value is recorded in the
statement of operations as sales, marketing and administrative expenses.
Results of Operations
The accompanying condensed consolidated statement of operations for the nine months ended
September 30, 2009 reflect the operating results of Cervitech since the date of the acquisition.
The amount of loss attributable to Cervitech included in the Companys consolidated statement of
operations from the acquisition date to September 30, 2009 was $1.5 million. For the three and nine
months ended September 30, 2009, the Companys consolidated results of operations include
acquisition-related expenses related to this acquisition of $0 and $1.2 million, respectively,
which are included in sales, marketing and administrative expenses.
The Company has prepared the following unaudited pro forma financial statement information to
compare results of the periods presented assuming the Cervitech acquisition had occurred as of
January 1, 2008. These unaudited pro forma results have been prepared for comparative purposes only
and do not purport to be an indicator of the results of operations that would have actually
resulted had the acquisition occurred at the beginning of each of the periods presented, or of
future results of operations. Assuming the Cervitech acquisition occurred as of January 1, 2008,
the pro forma unaudited results of operations would have been as follows for the three and nine
months ended September 30, 2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
|
September 30, |
|
September 30, |
|
|
2009 |
|
2008 |
|
2009 |
|
2008 |
Revenue |
|
$ |
94,916 |
|
|
$ |
67,699 |
|
|
$ |
263,943 |
|
|
$ |
177,587 |
|
Net income (loss) attributable to NuVasive, Inc. |
|
$ |
5,064 |
|
|
$ |
(22,770 |
) |
|
$ |
2,679 |
|
|
$ |
(37,222 |
) |
Net income (loss) per share basic and diluted |
|
$ |
0.13 |
|
|
$ |
(0.62 |
) |
|
$ |
0.07 |
|
|
$ |
(1.03 |
) |
The above pro forma unaudited results of operations do not include pro forma adjustments
relating to costs of integration or post-integration cost reductions that may be incurred or
realized by the Company in excess of actual amounts incurred or realized through September 30,
2009.
Investment in Progentix Orthobiology, B.V.
On January 13, 2009, the Company completed the purchase of forty percent (40%) of the capital
stock of Progentix Orthobiology, B.V., a company organized under the laws of the Netherlands
(Progentix), from existing shareholders (the Progentix Shareholders) pursuant to a Preferred Stock
Purchase Agreement for $10 million in cash (the Initial Investment). Progentix has as its objective
the development and exploitation of knowledge and products in the field of bone defects and the
recovery of bone tissue in general. Progentix wishes to further extend the existing knowledge and
patent position in the field of Osteoinductive Bone Graft Material Technology. Since inception,
Progentix has incurred approximately $3.2 million in losses.
NuVasive and Progentix also entered into a Senior Secured Facility Agreement dated January 13,
2009, 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, NuVasive is not
obligated to provide additional funding to Progentix. Concurrent with the Preferred Stock Purchase
Agreement, NuVasive, Progentix and the Progentix Shareholders entered into an Option Purchase
Agreement dated January 13, 2009 (the Option Agreement), whereby NuVasive may be obligated (the Put
Option), upon the achievement within two years of certain milestones by Progentix, to purchase the
remaining sixty percent (60%) of capital stock of Progentix from its shareholders for $45 million,
payable in a combination of cash and/or NuVasive common stock at the Companys sole discretion,
subject to certain adjustments (the Remaining Shares).
NuVasive may also be obligated, in the event that Progentix achieves the milestones
contemplated above within the requisite two-year period, to make additional payments to Progentix
shareholders, excluding NuVasive, of up to an aggregate total of $25 million,
payable in a combination of cash and/or NuVasive common stock, at the Companys sole
discretion, subject to certain adjustments, upon completion of additional milestones and dependent
on NuVasives sales success. NuVasive also has the right under the Option
8
Agreement to purchase the
Remaining Shares (the Call Option) at any time between the second anniversary and the fourth
anniversary of the Option Agreement (the Option Period) for $35 million, payable in a combination
of cash and/or 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 $35 million. NuVasive and Progentix also entered into a Distribution Agreement dated
January 13, 2009, 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
earlier terminated in accordance with its terms.
In accordance with authoritative guidance issued by the FASB, the Company has determined that
Progentix is a variable interest entity (VIE) as it does not have the ability to finance its
activities without additional subordinated financial support and its equity investors will not
absorb their proportionate share of expected losses and will be limited in the receipt of the
potential residual returns of Progentix. Additionally, pursuant to this guidance, NuVasive is
considered its primary beneficiary as NuVasive has the obligation to absorb a majority of the
expected losses and the right to receive a majority of expected residual returns of Progentix. This
conclusion was reached due to the existence of the Put Option and Call Option to acquire the
Remaining Shares at prices that were fixed upon entry into the arrangement, with the specific
prices based upon the achievement of certain milestones within a specified period of time. The
fixed nature of the Put Option and the Call Option limit Progentix Shareholders potential future
returns. 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.
Pursuant to authoritative guidance, the equity interests in Progentix not owned by the Company
are reported as noncontrolling interests on the consolidated balance sheet of the Company. 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 in 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 should 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 September 30, 2009, 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
September 30, 2009, as it is not currently possible to predict the outcome of such milestones, the
Company concluded it is not probable that the milestones will be met and that the Remaining Shares
will become redeemable. The probability of redemption will be reevaluated on a quarterly basis.
9
In accordance with authoritative guidance, we have recorded the identifiable assets,
liabilities and noncontrolling interests in the VIE at their fair value upon initial consolidation.
There has been no material change to the balances consolidated at the date of the Initial
Investment, therefore only the balances consolidated as of September 30, 2009 are included below.
Total assets and liabilities of Progentix as of September 30, 2009 are as follows (in thousands):
|
|
|
|
|
Total current assets |
|
$ |
629 |
|
Identifiable intangible assets, net |
|
|
16,407 |
|
Goodwill |
|
|
12,654 |
|
Accounts payable & accrued expenses |
|
|
439 |
|
Other long term liabilities |
|
|
50 |
|
Deferred tax liabilities |
|
|
4,310 |
|
Noncontrolling interests |
|
|
13,689 |
|
Intangible assets consolidated pursuant to the Progentix investment are included in the
Intangible assets, net balance in the consolidated balance sheet as of September 30, 2009 and
consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
|
|
|
Average |
|
Gross |
|
|
|
|
|
Intangible |
|
|
Amortization |
|
Carrying |
|
Accumulated |
|
Assets, |
|
|
(in years) |
|
Amount |
|
Amortization |
|
Net |
Non-competition agreement |
|
|
2 |
|
|
$ |
300 |
|
|
$ |
107 |
|
|
$ |
193 |
|
Existing technology |
|
|
10 |
|
|
|
5,400 |
|
|
|
386 |
|
|
|
5,014 |
|
In-process research and development |
|
|
|
|
|
|
11,200 |
|
|
|
|
|
|
|
11,200 |
|
|
|
|
|
|
|
|
Total Progentix intangible assets |
|
|
|
|
|
$ |
16,900 |
|
|
$ |
493 |
|
|
$ |
16,407 |
|
|
|
|
|
|
|
|
Osteocel Biologics Business Acquisition
On July 24, 2008, NuVasive completed the acquisition of certain assets of Osiris Therapeutics,
Inc. (Osiris) (the Osteocel® Biologics Business Acquisition) for $35 million in cash paid at
closing pursuant to an Asset Purchase Agreement, as amended (the Asset Purchase Agreement). The
completion date of this transaction is referred to as the Technology Closing Date. At the
Technology Closing Date, the Company also entered into a Manufacturing Agreement, as amended
(collectively with the Asset Purchase Agreement, the Agreements) with Osiris. Under the terms of
these Agreements, NuVasive was obligated to make payments of up to $50 million in addition to the
amount paid at closing, including milestone-based contingent payments not to exceed $20.0 million
and non-contingent payments in the amount of $30.0 million.
As of September 30, 2009, the Company has paid $5 million in cash and made additional payments
of $12.5 million in the form of the issuance of 293,331 shares of NuVasive common stock on June 30,
2009 and $12.5 million in the form of the issuance of 307,814 shares of NuVasive common stock on
September 30, 2009, as payment in full for the non-contingent payments.
During March 2009, the Company made a $5 million cash payment towards the milestone-based
contingent payments. At September 30, 2009, the Company determined that the achievement of the
specified sales amount required for the payment of the remaining $15 million milestone-based
contingent payment will likely be achieved and accordingly, has recorded the $15 million as a
liability at September 30, 2009. This payment may be made in cash or through the delivery of
NuVasive common stock of equivalent value, at the Companys election.
The Companys purchase price allocation was updated in 2009 to reflect the milestone-based
payments made in 2009 and to reflect the impact of the amendments made to the Agreements in March
2009, which eliminated the performance contingencies applicable to $30 million of the $45 million
in then-remaining milestones. The Goodwill balance related to the Osteocel® Biologics Business
Acquisition was $33.7 million as of September 30, 2009. Goodwill represents the excess of the
purchase price over the fair value of tangible and identifiable intangible assets acquired.
10
Acquisition of Pedicle Screw Technology
In March 2008, NuVasive completed a buy-out of royalty obligations on SpheRx® pedicle screw
and related technology products and acquired new pedicle screw intellectual property for cash
payments aggregating $6.3 million. Of the aggregate purchase price, $2.1 million, representing the
present value of the expected future cash flows associated with the terminated royalty obligations,
was allocated to intangible assets to be amortized on a straight-line basis over a seven-year
period. The remaining $4.2 million was allocated to in-process research and development (IPR&D) as
the associated projects had not yet reached technological feasibility and had no alternative future
uses.
4. Balance Sheet Reserves
The balances of the reserves for accounts receivable and inventory are as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
2009 |
|
2008 |
Reserves for accounts receivable |
|
$ |
3,140 |
|
|
$ |
1,952 |
|
Reserves for excess and obsolete inventory |
|
|
4,405 |
|
|
|
2,778 |
|
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.
5. Goodwill and Intangible Assets
A summary of adjustments to the Goodwill balance for the nine months ended September 30, 2009
is as follows (in thousands):
|
|
|
|
|
Balance at December 31, 2008 |
|
$ |
2,332 |
|
Progentix Investment (Note 3) |
|
|
12,654 |
|
Cervitech Acquisition (Note 3) |
|
|
54,825 |
|
First payment under the Osteocel March 2009 Amendments (Note 3) |
|
|
5,000 |
|
Record non-contingent payment pursuant to Osteocel March 2009 Amendments (Note 3) |
|
|
12,454 |
|
Record milestone-based payment pursuant to Osteocel March 2009 Amendments (Note 3) |
|
|
14,999 |
|
|
|
|
|
Balance at September 30, 2009 |
|
$ |
102,264 |
|
|
|
|
|
Identifiable intangible assets consisted of the following as of September 30, 2009 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Gross |
|
|
|
|
|
|
|
|
|
Amortization |
|
|
Carrying |
|
|
Accumulated |
|
|
Intangible |
|
|
|
(in years) |
|
|
Amount |
|
|
Amortization |
|
|
Assets, net |
|
Intangible Assets Subject to Amortization: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Trade name and trademarks |
|
|
14 |
|
|
$ |
5,900 |
|
|
$ |
(412 |
) |
|
$ |
5,488 |
|
Customer relationships |
|
|
14 |
|
|
|
9,730 |
|
|
|
(2,008 |
) |
|
|
7,722 |
|
Developed technology |
|
|
14 |
|
|
|
31,975 |
|
|
|
(5,039 |
) |
|
|
26,936 |
|
Manufacturing know-how and trade secrets |
|
|
13 |
|
|
|
20,408 |
|
|
|
(1,953 |
) |
|
|
18,455 |
|
In-process research and development |
|
|
|
|
|
|
46,000 |
|
|
|
|
|
|
|
46,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
114,013 |
|
|
$ |
(9,412 |
) |
|
$ |
104,601 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible Assets Not Subject to Amortization: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Goodwill |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
102,264 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Intangible assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
206,865 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11
Future estimated amortization expense related to acquired intangible assets subject to
amortization is as follows (in thousands):
|
|
|
|
|
Remaining 2009 |
|
$ |
1,417 |
|
2010 |
|
|
5,777 |
|
2011 |
|
|
8,840 |
|
2012 |
|
|
8,817 |
|
2013 |
|
|
8,810 |
|
2014 |
|
|
8,775 |
|
Thereafter |
|
|
62,165 |
|
|
|
|
|
|
|
$ |
104.601 |
|
|
|
|
|
Amortization expense was $1.4 million and $0.9 million for the three months ended September
30, 2009 and 2008, respectively, and $4.1 million and $1.8 million for the nine months ended
September 30, 2009 and 2008, respectively. In-process research and development will be amortized
beginning with the first sale of the respective acquired products over its estimated useful life of
13years. Through September 30, 2009, no amortization expense has been recorded for IPR&D.
6. 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 will 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. The Notes mature on March 15, 2013 (the Maturity Date). The fair value of the
outstanding notes approximates their carrying value as of September 30, 2009.
The Notes will be 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,
subject to adjustment. The cost of the Hedge that was not covered by the proceeds from the sale of
the Warrants was approximately $14.0 million and is reflected as a reduction of additional paid-in
capital as of September 30, 2009. 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.
7. Net Income (Loss) Per Share
Basic earnings (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. There were no potentially dilutive common shares
related to the Companys 2.25% Convertible Senior Notes due 2013, or the related warrants, for the
three and nine months ended September 30, 2009 and 2008, as the Companys average stock price for
the respective periods was less than the conversion price (approximately $44.74) of the Notes.
12
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
(in thousands, except per share amounts) |
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
Numerator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) attributable to NuVasive, Inc. |
|
$ |
5,064 |
|
|
$ |
(23,079 |
) |
|
$ |
3,527 |
|
|
$ |
(31,228 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator for basic and diluted net loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding for basic |
|
|
37,733 |
|
|
|
35,931 |
|
|
|
37,008 |
|
|
|
35,674 |
|
Dilutive potential common stock outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options |
|
|
1,421 |
|
|
|
|
|
|
|
1,342 |
|
|
|
|
|
Restricted stock units |
|
|
62 |
|
|
|
|
|
|
|
34 |
|
|
|
|
|
|
|
|
Weighted average common shares outstanding for
diluted |
|
|
39,216 |
|
|
|
35,931 |
|
|
|
38,384 |
|
|
|
35,674 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income (loss) per share attributable to
NuVasive, Inc. |
|
$ |
0.13 |
|
|
$ |
(0.64 |
) |
|
$ |
0.10 |
|
|
$ |
(0.88 |
) |
|
|
|
Diluted net income (loss) per share attributable to
NuVasive, Inc. |
|
$ |
0.13 |
|
|
$ |
(0.64 |
) |
|
$ |
0.09 |
|
|
$ |
(0.88 |
) |
|
|
|
During
the three and nine month periods ended September 30, 2009, a
weighted average of 1.3 million
options and 2.5 million options, respectively, to purchase shares of common stock were not included
in the computation of diluted earnings per share as their effect would have been antidilutive.
8. Comprehensive Income (Loss)
The components of comprehensive income (loss) are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
Net income (loss) |
|
$ |
4,436 |
|
|
$ |
(23,079 |
) |
|
$ |
2,216 |
|
|
$ |
(31,228 |
) |
Other comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized loss on investments |
|
|
(41 |
) |
|
|
(202 |
) |
|
|
(340 |
) |
|
|
(318 |
) |
Translation adjustments |
|
|
279 |
|
|
|
(76 |
) |
|
|
741 |
|
|
|
(99 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income (loss) |
|
|
4,674 |
|
|
|
(23,357 |
) |
|
|
2,617 |
|
|
|
(31,645 |
) |
Amounts attributable to noncontrolling interests |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
628 |
|
|
|
|
|
|
|
1,311 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income (loss) attributable to NuVasive, Inc. |
|
$ |
5,302 |
|
|
$ |
(23,357 |
) |
|
$ |
3,928 |
|
|
$ |
(31,645 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
9. Marketable Securities
Marketable securities consist of corporate debt securities, U.S. government treasury
securities and government sponsored entities. We classify 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.
13
The composition of marketable securities is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
|
|
|
|
Maturity in |
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Estimated |
|
|
|
Years |
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Fair Value |
|
September 30, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government treasury securities |
|
Less than 1 |
|
$ |
17,986 |
|
|
$ |
37 |
|
|
$ |
(2 |
) |
|
$ |
18,021 |
|
Securities of government-sponsored entities |
|
Less than 1 |
|
|
32,021 |
|
|
|
67 |
|
|
|
(2 |
) |
|
|
32,086 |
|
Certificates of deposit |
|
Less than 1 |
|
|
1,840 |
|
|
|
|
|
|
|
(2 |
) |
|
|
1,838 |
|
Corporate notes |
|
Less than 1 |
|
|
3,943 |
|
|
|
27 |
|
|
|
|
|
|
|
3,970 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term marketable securities |
|
|
|
|
55,790 |
|
|
|
131 |
|
|
|
(6 |
) |
|
|
55,915 |
|
Securities of government-sponsored entities |
|
1 to 2 |
|
|
9,997 |
|
|
|
35 |
|
|
|
|
|
|
|
10,032 |
|
|
|
|
|
|
Total marketable securities at September 30, 2009 |
|
|
|
$ |
65,787 |
|
|
$ |
166 |
|
|
$ |
(6 |
) |
|
$ |
65,947 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commercial paper |
|
Less than 1 |
|
$ |
1,213 |
|
|
|
|
|
|
|
(2 |
) |
|
$ |
1,211 |
|
Corporate notes |
|
Less than 1 |
|
|
4,283 |
|
|
|
4 |
|
|
|
(6 |
) |
|
|
4,281 |
|
Securities of government-sponsored entities |
|
Less than 1 |
|
|
40,054 |
|
|
|
197 |
|
|
|
(5 |
) |
|
|
40,246 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term marketable securities |
|
|
|
|
45,550 |
|
|
|
201 |
|
|
|
(13 |
) |
|
|
45,738 |
|
Corporate notes |
|
1 to 3 |
|
|
4,467 |
|
|
|
15 |
|
|
|
(52 |
) |
|
|
4,430 |
|
Securities of government-sponsored entities |
|
1 to 3 |
|
|
40,495 |
|
|
|
380 |
|
|
|
|
|
|
|
40,875 |
|
|
|
|
|
|
Total marketable securities at December 31, 2008 |
|
|
|
$ |
90,512 |
|
|
$ |
596 |
|
|
$ |
(65 |
) |
|
$ |
91,043 |
|
|
|
|
|
|
As of September 30, 2009, we had no significant investment positions that were in an
unrealized loss position. We review our 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 our intent and ability to hold the investment for a period of time sufficient to allow for any
anticipated recovery in market value. We maintain an investment portfolio of various holdings,
types and maturities. We do not use derivative financial instruments. We place our cash investments
in instruments that meet high credit quality standards, as specified in our investment policy
guidelines. These guidelines also limit the amount of credit exposure to any one issue, issuer or
type of instrument.
10. Fair Value Measurements
Effective January 1, 2008, the Company adopted the authoritative guidance for the fair value
measurements, which defines fair value, establishes a framework for measuring fair value under
generally accepted accounting principles, and expands disclosures about fair value measurements.
The Company measures certain assets at fair value and thus there was no impact on the Companys
consolidated financial statements upon adoption of the guidance. The guidance 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.
14
The fair values of the Companys assets and liabilities, 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 Inputs |
|
|
Total |
|
(Level 1) |
|
(Level 2) |
|
(Level 3) |
|
|
|
September 30, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Marketable Securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S government treasury securities |
|
$ |
18,021 |
|
|
$ |
18,021 |
|
|
$ |
|
|
|
$ |
|
|
Securities of government-sponsored entities |
|
|
42,118 |
|
|
|
|
|
|
|
42,118 |
|
|
|
|
|
Corporate notes |
|
|
3,970 |
|
|
|
|
|
|
|
3,970 |
|
|
|
|
|
Certificates of deposit |
|
|
1,838 |
|
|
|
1,838 |
|
|
|
|
|
|
|
|
|
|
|
|
Total marketable securities at September 30, 2009 |
|
$ |
65,947 |
|
|
$ |
19,859 |
|
|
$ |
46,088 |
|
|
$ |
|
|
|
|
|
Contingent Consideration: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term acquisition related liabilities |
|
$ |
(30,318 |
) |
|
$ |
|
|
|
$ |
|
|
|
$ |
(30,318 |
) |
|
|
|
Effective January 1, 2009, the Company implemented the authoritative guidance for nonfinancial
assets and liabilities that are remeasured at fair value on a non-recurring basis. As the Company
has not elected to measure any financial assets or liabilities at fair value that were not
previously required to be remeasured at fair value, the adoption of this guidance did not have a
material impact on the financial position or results of operations. However, it could have an
impact in future periods. In addition, the Company may have additional disclosure requirements in
the event we complete an acquisition or incur asset impairment in future periods.
11. Income Taxes
Deferred income tax assets and liabilities are recognized for temporary differences between
financial statement and income tax carrying values using tax rates in effect for the years such
differences are expected to reverse. At December 31, 2008, the Company had net deferred tax assets
of $85.4 million primarily attributable to net operating loss
carry-overs, research and experimentation
credits, original issue discount, stock-based compensation expense and fixed assets. Due to
uncertainties surrounding the Companys ability to generate future taxable income to realize such
deferred income tax assets, a full valuation allowance has been established. With immaterial
exception, the Company continues to maintain a full valuation allowance against its deferred tax
assets as of September 30, 2009.
On July 13, 2006, the FASB issued authoritative guidance related to recognizing and measuring
tax positions taken or expected to be taken in a tax return which requires that uncertain income
tax positions on income tax returns must be recognized at the largest amount that is
more-likely-than-not to be sustained upon audit by the relevant tax authority. An uncertain income
tax position will not be recognized if it has less than a 50% likelihood of being sustained.
Additionally, guidance on de-recognition, classification, interest and penalties, accounting in
interim periods, disclosure and transition was provided. The Company adopted this authoritative
guidance on January 1, 2007, its effective date. There have been no changes in unrecognized tax
benefits or other items since December 31, 2008 and as such, disclosures included in the Companys
2008 Annual Report on Form 10-K continue to be relevant for the period ended September 30, 2009.
15
12. 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 assumptions used to estimate the fair value of stock awards granted in the three and nine
months ended September 30, 2009 and 2008 are as follows:
|
|
|
|
|
|
|
Three and Nine Months |
|
Three and Nine Months |
|
|
Ended September 30, 2009 |
|
Ended September 30, 2008 |
Stock Options |
|
|
|
|
Volatility |
|
45% to 48% |
|
42% |
Expected term (years) |
|
3.3 to 4.9 |
|
2.5 to 4.5 |
Risk free interest rate |
|
1.36% to 2.51% |
|
2.46% to 3.41% |
Expected dividend yield |
|
0.0% |
|
0.0% |
ESPP |
|
|
|
|
Volatility |
|
40% to 65% |
|
42% to 65% |
Expected term (years) |
|
0.5 to 2 |
|
0.5 to 2 |
Risk free interest rate |
|
0.92% to 4.86% |
|
3.03% to 4.86% |
Expected dividend yield |
|
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 |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
(in thousands, except per share amounts) |
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
Sales, marketing and administrative expense |
|
$ |
4,265 |
|
|
$ |
4,499 |
|
|
$ |
14,748 |
|
|
$ |
13,541 |
|
Research and development expense |
|
|
901 |
|
|
|
922 |
|
|
|
3,417 |
|
|
|
2,178 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation expense |
|
$ |
5,166 |
|
|
$ |
5,421 |
|
|
$ |
18,165 |
|
|
$ |
15,719 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect on basic net income (loss) per share |
|
$ |
(0.14 |
) |
|
$ |
(0.15 |
) |
|
$ |
(0.49 |
) |
|
$ |
(0.44 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect on diluted net income (loss) per share |
|
$ |
(0.13 |
) |
|
$ |
(0.15 |
) |
|
$ |
(0.47 |
) |
|
$ |
(0.44 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
Restricted Stock Units
During the nine months ended September 30, 2009, approximately 260,500 time-vested restricted
stock units, or RSUs, were granted at a grant date fair value of $36.49 per share. For the three
and nine months ended September 30, 2009, the Company recorded $0.9 million and $2.2 million,
respectively, of stock-based compensation expense related to RSUs. During the three and nine months
ended September 30, 2008, there were no RSUs granted.
13. Building Lease
In August 2008, the Company relocated its corporate headquarters to a two-building campus
style complex in San Diego. In connection with this relocation, in the third quarter of 2008, the
Company recorded a liability for approximately $3.9 million related to lease termination costs in
connection with vacating the Companys former corporate headquarters. During the third quarter of
2009, due to continued growth, the Company decided to reoccupy the former corporate headquarters
facility. Accordingly, at August 31, 2009, the remaining lease termination costs liability of $2.0
was reversed and is recorded as a reduction of sales, marketing, and administrative expenses for
the three and nine months ended September 30, 2009.
16
14. Impact of Recently Issued Accounting Standards
Recently Adopted Accounting Standards
Effective January 1, 2009, the Company implemented the FASBs revised authoritative guidance
for business combinations. This revised guidance requires an acquiring company to measure all
assets acquired and liabilities assumed, including contingent considerations and all contractual
contingencies, at fair value as of the acquisition date. In addition, an acquiring company is
required to capitalize in-process research and development and either amortize it over the life of
the product, or write it off if the project is abandoned or impaired. Previously, post-acquisition
adjustments related to business combination deferred tax asset valuation allowances and liabilities
for uncertain tax positions were generally required to be recorded as an increase or decrease to
Goodwill. The revised guidance does not permit this accounting and, generally, requires any such
changes to be recorded in current period income tax expense. Thus, all changes to valuation
allowances and liabilities for uncertain tax positions established in acquisition accounting,
regardless of the guidance used to initially account for the business combination, will be
recognized in current period income tax expense. The adoption of the revised guidance will have an
impact on the Companys consolidated financial statements, but the nature and magnitude of the
specific effects will depend upon the nature, terms and size of the acquisitions consummated after
the effective date of January 1, 2009.
Effective January 1, 2009, the Company adopted the revised authoritative guidance for the
accounting treatment afforded preacquisition contingencies in a business combination. Under the
revised guidance, an acquirer is required to recognize at fair value an asset acquired or
liability assumed in a business combination that arises from a contingency if the acquisition-date
fair value of the liability can be determined during the measurement period. If the
acquisition-date fair value cannot be determined, the acquirer will apply the authoritative
guidance used to evaluate contingencies to determine whether the contingency should be recognized
as of the acquisition date or after the acquisition date. The adoption of the revised guidance
will have an impact on the Companys consolidated financial statements, but the nature and
magnitude of the specific effects will depend upon the nature, terms and size of the acquisitions
consummated after the effective date of January 1, 2009.
Effective January 1, 2009, the Company implemented FASBs revised authoritative guidance for
consolidation, which addresses the accounting and reporting standards for ownership interests in
subsidiaries held by parties other than the parent, the amount of consolidated net income
attributable to the parent and to the noncontrolling interest, changes in a parents ownership
interest, and the valuation of retained noncontrolling equity investments when a subsidiary is
deconsolidated. The guidance also establishes disclosure requirements that clearly identify and
distinguish between the interests of the parent and the interests of the noncontrolling owners. The
adoption of the revised guidance is expected to impact the Companys consolidated financial
statements, but the nature and magnitude of the specific effects will depend upon the nature, terms
and size of the investments made after the effective date of January 1, 2009.
Effective January 1, 2009, the Company adopted the FASBs revised authoritative guidance which
amends the factors that should be considered in developing renewal or extension assumptions used to
determine the useful life of a recognized intangible asset. This guidance requires enhanced
disclosures concerning a companys treatment of costs incurred to renew or extend the term of a
recognized intangible asset. The adoption of this guidance did not have a material impact on our
consolidated financial position, results of operations or cash flows.
Effective April 1, 2009, the Company adopted FASBs revised authoritative guidance for fair
value measurements which clarifies the measurement of fair value in a market that is not active,
and is effective as of the issue date, including application to prior periods for which financial
statements have not been issued. The Company also adopted additional authoritative guidance for
determining whether a market is active or inactive, and whether a transaction is distressed, is
applicable to all assets and liabilities (financial and nonfinancial) and which requires enhanced
disclosures. The adoption of this guidance did not have a material impact on our consolidated
financial position, results of operations or cash flows.
Effective April 1, 2009, the Company adopted authoritative guidance which provides additional
guidance to provide greater clarity about the credit and noncredit component of an
other-than-temporary impairment event and to more effectively communicate when an
other-than-temporary impairment event has occurred. The adoption of this guidance, which applies
to investments in debt securities, did not have a material impact on our consolidated financial
position, results of operations or cash flows.
17
Recently Issued Accounting Standards
In June 2009, the FASB issued authoritative guidance for consolidations, which amends the
consolidation guidance that applies to variable interest entities and significantly affects the
overall consolidation analysis under previously issued guidance. This guidance is effective for
years beginning January 1, 2010. The Company is currently evaluating the impact the adoption will
have on its consolidated financial statements.
15. Legal Proceedings
Medtronic Sofamor Danek USA, Inc. Litigation
As previously disclosed, in August 2008, Medtronic Sofamor Danek USA, Inc. and its related
entities (Medtronic) filed suit against NuVasive in the United States District Court for the
Southern District of California (Medtronic Litigation), alleging that certain of NuVasives
products infringe, or contribute to the infringement of, twelve U.S. patents assigned or licensed
to Medtronic. Three of the patents were later withdrawn by Medtronic, leaving nine patents.
NuVasive brought counterclaims against Medtronic alleging infringement of certain of NuVasives
patents. Because of the number of patents involved, each side selected three patents to proceed
with in the first phase of the litigation. The Medtronic Litigation is still in its early stages.
NuVasive believes its own claims have merit and that Medtronics claims lack merit. As of September
30, 2009, 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.
16. Subsequent Event
On
November 4, 2009, the Company issued 400,277 shares of its common stock to Osiris for the
payment of the remaining $15 million milestone-based contingent payment that was recorded as a
liability at September 30, 2009.
|
|
|
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 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
ending December 31, 2008. 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 product portfolio is focused primarily on the
$4.6 billion U.S. spine implant market. Additionally, we have expanded into the $1.5 billion global
biologics market, the $1.5 billion international spine implant market, and are developing products
for the emerging motion preservation market.
Our principal product offering is based on our Maximum Access Surgery, or MAS® platform. The
MAS platform combines four categories of products that collectively minimize soft tissue disruption
during spine surgery with maximum visualization and safe, easy reproducibility for the surgeon:
NeuroVision®, a proprietary software-driven nerve avoidance system; MaXcess®, a unique split-blade
retractor system; a wide variety of specialized implants; and several biologic fusion enhancers.
MAS significantly reduces surgery time and returns patients to activities of daily living much
faster than conventional approaches. Having redefined spine surgery with the MAS platforms lateral
approach, known as eXtreme Lateral Interbody Fusion, or XLIF®, we have built an entire spine
franchise. With over 50 products today that span lumbar, thoracic and cervical applications, we
will continue to expand and evolve our offering predicated on our R&D focus and dedication to
outstanding service levels supported by our culture of Absolute Responsiveness®.
18
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. We enhanced our biologic
offering in 2007 with the acquisition of rights to FormaGraft®, a collagen synthetic product used
to aid the fusion process. This offering expanded in 2008 with the acquisition of Osteocel® from
Osiris Therapeutics, an allograft cellular matrix containing viable mesenchymal stem cells, or
MSCs, to aid in spinal fusion. In 2009, we further developed NuVasives biologic portfolio via an
investment into Progentix, a company with a novel Osteoinductive synthetic that has properties
similar to BMP as well as a proprietary manufacturing process that creates superior microstructure
using calcium phosphate.
We also offer a suite of traditional spine surgery products, including certain products in our
CoRoent suite of implants, a titanium surgical mesh system, a line of precision-machined cervical
and lumbar allograft implants, and related instrumentation. Our Triad® and Extensure®
lines of bone allograft, in our patented saline packaging, is human bone that has been processed
and precision shaped for transplant. We also offer fusion fixation products that offer unique
technological benefits such as our Helix® and Gradient
PlusTM cervical plate
systems and SpheRx pedicle screw system.
We have an active product development pipeline focused on expanding our current fusion product
platform as well as products designed to preserve spinal motion. In May 2009, we acquired
Cervitech, a company focused on clinical approval of the PCM cervical disc system, a motion
preserving total disc replacement device. Enrollment of the pivotal trial is complete and the trial
protocol requires a two-year follow up period on all patients before submitting to the FDA for
potential approval. In August 2008, we completed the enrollment of our pivotal clinical trial for
NeoDisc®, our cervical disc replacement device. The trial protocol requires a two-year follow up
period on all patients before submitting to the FDA for potential approval.
From inception through September 30, 2009, we had an accumulated deficit of approximately
$192.0 million.
Recent Developments
In January 2009, we purchased forty percent (40%) of the capital stock of Progentix
Orthobiology, B.V., a company organized under the laws of the Netherlands (Progentix), from
existing shareholders for $10 million in cash (the Initial Investment). Progentix has as its
objective the development and exploitation of knowledge and products in the field of bone defects
and the recovery of bone tissue in general. Progentix wishes to further extend the existing
knowledge and patent position in the field of Osteoinductive Bone Graft Material Technology.
In May 2009, we purchased Cervitech® Inc., (Cervitech), a New Jersey based company focused on
clinical approval of the PCM® cervical disc system, a motion preserving total disc replacement
device, for an initial purchase price of approximately $48 million, consisting of cash totaling
approximately $24 million and the issuance of 638,261 shares of NuVasive common stock to certain
stockholders of Cervitech. This strategic acquisition allows us the potential to accelerate our
entry into the growing mechanical cervical disc replacement market. Currently, the PCM
investigational device is in an FDA-approved clinical trial in the United States and two-year
follow up is scheduled to be completed in the fourth quarter of 2009. We anticipate submitting for
FDA approval in the first quarter of 2010. The potential approval will further strengthen our
cervical product offering and will enable us to continue our trend of increasing our market share.
Revenues. 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 provided they commit to minimum monthly purchases of disposables and implants. 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 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.
Sales and Marketing. Through September 30, 2009, substantially all of our operations are
located in the United States and substantially all of our sales to date 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
19
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 continuing our expansion in 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.
Critical Accounting Policies
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, 2008 and there have been no material changes
during the three and nine months ended September 30, 2009.
New accounting requirements.
Effective January 1, 2009, we implemented the Financial Accounting Standards Boards (FASB)
revised authoritative guidance for business combinations. This revised guidance requires an
acquiring company to measure all assets acquired and liabilities assumed, including contingent
considerations and all contractual contingencies, at fair value as of the acquisition date. In
addition, an acquiring company is required to capitalize in-process research and development and
either amortize it over the life of the product, or write it off if the project is abandoned or
impaired. Previously, post-acquisition adjustments related to business combination deferred tax
asset valuation allowances and liabilities for uncertain tax positions were generally required to
be recorded as an increase or decrease to Goodwill. The revised guidance does not permit this
accounting and, generally, requires any such changes to be recorded in current period income tax
expense. Thus, all changes to valuation allowances and liabilities for uncertain tax positions
established in acquisition accounting, regardless of the guidance used to initially account for the
business combination, will be recognized in current period income tax expense. The adoption of the
revised guidance will have an impact on our consolidated financial statements, but the nature and
magnitude of the specific effects will depend upon the nature, terms and size of the acquisitions
consummated after the effective date of January 1, 2009.
Effective January 1, 2009, we implemented FASBs revised authoritative guidance for
consolidation, which addresses the accounting and reporting standards for ownership interests in
subsidiaries held by parties other than the parent, the amount of consolidated net income
attributable to the parent and to the noncontrolling interest, changes in a parents ownership
interest, and the valuation of retained noncontrolling equity investments when a subsidiary is
deconsolidated. The guidance also establishes disclosure requirements that clearly identify and
distinguish between the interests of the parent and the interests of the noncontrolling owners. The
adoption of the revised guidance is expected to impact our consolidated financial statements, but
the nature and magnitude of the specific effects will depend upon the nature, terms and size of the
investments made after the effective date of January 1, 2009. We will apply the provisions of
this revised guidance when we have such noncontrolling interests.
On January 1, 2009, we adopted the FASBs revised authoritative guidance for determining the
useful life of intangible assets. The guidance is intended to improve the consistency between the
useful life of a recognized intangible asset and the period of expected cash flows used to measure
the fair value of the asset under other U.S. generally accepted accounting principles. The
application of this guidance did not have a material impact on our consolidated financial position,
results of operations or cash flows.
Results of Operations
Revenue
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
(dollars in thousands) |
|
2009 |
|
2008 |
|
$ Change |
|
% Change |
Three months ended |
|
$ |
94,916 |
|
|
$ |
66,915 |
|
|
$ |
28,001 |
|
|
|
41.8 |
% |
Nine months ended |
|
$ |
263,405 |
|
|
$ |
175,501 |
|
|
$ |
87,904 |
|
|
|
50.1 |
% |
20
Revenues have increased over time due primarily to continued market acceptance of our products
within our MAS® platform, including NeuroVision® and MaXcess ® disposables, our Biologics offering,
and our specialized implants such as our XLP® lateral plate, SpheRx® pedicle screw
systems, and CoRoent® suite of products. 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.
Cost of Goods Sold
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
(dollars in thousands) |
|
2009 |
|
2008 |
|
$ Change |
|
% Change |
Three months ended |
|
$ |
18,417 |
|
|
$ |
12,195 |
|
|
$ |
6,222 |
|
|
|
51.0 |
% |
% of revenue |
|
|
19.4 |
% |
|
|
18.2 |
% |
|
|
|
|
|
|
|
|
Nine months ended |
|
$ |
49,901 |
|
|
$ |
30,845 |
|
|
$ |
19,056 |
|
|
|
61.8 |
% |
% of revenue |
|
|
18.9 |
% |
|
|
17.6 |
% |
|
|
|
|
|
|
|
|
Cost of goods sold consists of purchased goods and overhead costs, including depreciation
expense for instruments.
The increase in cost of goods sold in total dollars in the three and nine months ended
September 30, 2009 compared to the same periods in 2008, resulted primarily from (i) increased
direct costs of $6.2 million and $15.6 million, respectively, primarily to support revenue growth;
and (ii) increased depreciation expense of $1.0 million and $3.5 million, respectively, incurred on
the increased amount of surgical instrument sets we hold for use in surgeries. We expect cost of
goods sold, as a percentage of revenue, to remain at these levels for the remainder of 2009.
Operating Expenses
Sales, Marketing and Administrative.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
(dollars in thousands) |
|
2009 |
|
2008 |
|
$ Change |
|
% Change |
Three months ended |
|
$ |
59,761 |
|
|
$ |
54,557 |
|
|
$ |
5,204 |
|
|
|
9.5 |
% |
% of revenue |
|
|
63.0 |
% |
|
|
81.5 |
% |
|
|
|
|
|
|
|
|
Nine months ended |
|
$ |
176,391 |
|
|
$ |
135,975 |
|
|
$ |
40,416 |
|
|
|
29.7 |
% |
% of revenue |
|
|
67.0 |
% |
|
|
77.5 |
% |
|
|
|
|
|
|
|
|
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; shipping costs; surgeon training costs; shareowner (employee) related
expenses for our administrative functions; third party professional service fees; amortization of
acquired intangible assets; and facilities and insurance expenses.
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.
Increases in costs based on revenue, such as sales force compensation and other direct costs
related to the sales force, royalty expense, and shipping costs, were $6.4 million and $21.4
million for the three and nine months ended September 30, 2009, respectively, compared to the same
periods in 2008. The increases are consistent with our increased revenue growth of approximately
50% in the first nine months of 2009 as compared to the same period in 2008. Total costs related to
our sales force, as a percent of revenue, decreased to 28.8% from 30.3% for the three months ended
September 30, 2009 compared to the same period in 2008. The decrease in costs as a percentage of
revenue was primarily attributable to the increased revenues.
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 personnel costs increased $4.6 million and $12.4
21
million for the three and nine months ended September 30, 2009, respectively, compared to the
same periods in 2008. Facility, equipment and computer expenses increased by $0.9 million and $4.5
million for the three and nine months ended September 30, 2009, respectively, compared to the same
periods in 2008, primarily as a result of continued headcount growth and increased facility costs
to support the increasing number of shareowners (employees).
During the first quarter of 2009, we adopted the FASBs revised authoritative guidance for
business combinations, which requires that acquisition related costs be expensed in the period in
which the costs are incurred. This differs from previous accounting treatment in that the
acquisition related expenses were included as part of the purchase price of the acquired company.
We incurred approximately $2.3 million in acquisition related costs in connection with our
investment in Progentix and acquisition of Cervitech in the nine months ended September 30, 2009
with no comparable expense during the same periods in 2008.
The increases in costs discussed above were offset by decreases in costs for the three and
nine months ended September 30, 2009 compared to the same periods in 2008, related to charges
totaling $7.4 million for vacating the Companys previous corporate headquarters and incremental
transition costs related to our ERP system which were recorded in the three and nine months ended
September 30, 2008. In August 2008, we relocated our corporate headquarters to a two-building
campus style complex in San Diego. In connection with vacating our former corporate headquarters,
we recorded a charge of approximately $4.8 million to sales, marketing, and administrative expenses
for lease termination costs and other related items. In addition, during the three and nine months
ended September 30, 2008, we incurred non-capitalizable expenses totaling $2.6 million related to
the implementation of our new ERP system which was completed in the third quarter of 2008. During
the third quarter of 2009, due to continued growth, we decided to reoccupy the former corporate
headquarters facility. Accordingly, at August 31, 2009, the remaining liability related to lease
termination costs of $2.0 million was reversed and is recorded as a reduction of sales, marketing,
and administrative expenses for the three and nine months ended September 30, 2009.
The total capitalized costs of $10.9 million incurred in 2008 related to the ERP project are
being amortized over a 7-year period which began in July 2008.
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 synergies of
investments we have made.
Research and Development.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
(dollars in thousands) |
|
2009 |
|
2008 |
|
$ Change |
|
% Change |
Three months ended |
|
$ |
10,654 |
|
|
$ |
6,396 |
|
|
$ |
4,258 |
|
|
|
66.6 |
% |
% of revenue |
|
|
11.2 |
% |
|
|
9.6 |
% |
|
|
|
|
|
|
|
|
Nine months ended |
|
$ |
30,047 |
|
|
$ |
19,797 |
|
|
$ |
10,250 |
|
|
|
51.8 |
% |
% of revenue |
|
|
11.4 |
% |
|
|
11.3 |
% |
|
|
|
|
|
|
|
|
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.
The increase in research and development costs in the periods presented are primarily due to
expenses related to litigation support costs of $0.8 million and $3.4 million incurred during the
three and nine months ended September 30, 2009, respectively, with no comparable expenses during
the same periods in 2008. Compensation and other shareowner related expenses increased $1.4 million
and $4.0 million, for the three and nine months ended September 30, 2009, respectively, including
an increase in stock-based compensation of $1.2 million for the nine months ended September 30,
2009, compared to the same periods in 2008, primarily due to increased headcount to support our
product development and enhancement efforts. We expect research and development costs to continue
to increase in absolute dollars for the foreseeable future in support of our ongoing development
activities and planned clinical trial activities.
In-Process Research and Development.
For the nine months ended September 30, 2008, we recorded in-process research and development
(IPR&D) charges of $20.9 million related to the acquisitions of pedicle screw technology and
Osteocel. As of the date of the acquisitions, the projects associated with the IPR&D efforts had
not yet reached technological feasibility and the research and development in-process had no
alternative
22
future uses. Accordingly, the amounts were charged to expense on the acquisition dates in
accordance with the authoritative guidance in effect on the dates of acquisition.
During the first quarter 2009, we adopted the FASBs revised authoritative guidance for
business combinations, which is applied prospectively for all new business acquisitions entered
into after January 1, 2009 and provides that IPR&D acquired is no longer charged to expense on the
acquisition date, but rather recorded as an asset on the balance sheet. Amounts recorded as IPR&D
beginning after January 1, 2009, will begin being amortized upon first sales of the product over
the estimated useful life of the technology. As of September 30, 2009, we have recorded
approximately $46.0 million on our balance sheet related to IPR&D in conjunction with the Progentix
Investment and acquisition of Cervitech, as described above. In accordance with this authoritative
guidance, as the technology has not yet been approved, the amortization of the acquired IPR&D has
not begun. In addition, there were no charges to the statement of operations during the first six
months of 2009.
Interest and Other Income, Net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
|
|
(dollars in thousands) |
|
2009 |
|
|
2008 |
|
|
$ Change |
|
|
% Change |
|
Three months ended: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
$ |
203 |
|
|
$ |
1,460 |
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
(1,609 |
) |
|
|
(1,719 |
) |
|
|
|
|
|
|
|
|
Other income (expense), net |
|
|
(242 |
) |
|
|
113 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total interest and other income (expense), net |
|
$ |
(1,648 |
) |
|
$ |
(146 |
) |
|
$ |
(1,502 |
) |
|
|
(1028.8 |
%) |
|
|
|
|
|
|
|
|
|
|
|
% of revenue |
|
|
1.7 |
% |
|
|
0.2 |
% |
|
|
|
|
|
|
|
|
Nine months ended: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
$ |
1,318 |
|
|
$ |
4,373 |
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
(5,439 |
) |
|
|
(3,816 |
) |
|
|
|
|
|
|
|
|
Other income (expense), net |
|
|
(729 |
) |
|
|
207 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total interest and other income (expense), net |
|
$ |
(4,850 |
) |
|
$ |
764 |
|
|
$ |
(5,614 |
) |
|
|
(734.8 |
%) |
|
|
|
|
|
|
|
|
|
|
|
% of revenue |
|
|
1.8 |
% |
|
|
0.4 |
% |
|
|
|
|
|
|
|
|
Interest and other income (expense), net, consists primarily of interest income earned on
marketable securities offset by interest expense incurred related to the Companys convertible debt
offering signed in March 2008. The net change in these amounts in the periods presented is
principally due to (i) an increase of $1.6 million in interest expense for the nine months ended
September 30, 2009 related to the convertible debt offering due to having a full period of interest
expense in the 2009 period as compared to only partial period during the same 2008 period, and (ii)
lower balances in marketable securities in 2009, coupled with lower interest rates, resulting in a
decrease of $1.3 million and $3.1 million in interest income for the three and nine months ended
September 30, 2009, respectively.
23
Stock-Based Compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine months ended |
|
|
|
September 30, |
|
|
September 30, |
|
(dollars in thousands) |
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
Sales, marketing and administrative expense |
|
$ |
4,265 |
|
|
$ |
4,499 |
|
|
$ |
14,748 |
|
|
$ |
13,541 |
|
Research and development expense |
|
|
901 |
|
|
|
922 |
|
|
|
3,417 |
|
|
|
2,178 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stock-based compensation expense |
|
$ |
5,166 |
|
|
$ |
5,421 |
|
|
$ |
18,165 |
|
|
$ |
15,719 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of revenue |
|
|
5.4 |
% |
|
|
8.1 |
% |
|
|
6.9 |
% |
|
|
9.0 |
% |
We granted approximately 1.4 million and 1.8 million options in the first nine months of 2009
and 2008, respectively, with a per option grant date weighted average fair value of $13.17 and
$14.49, respectively. In addition, in 2009 we granted approximately 260,500 restricted stock units
with a weighted average grant date fair value of $36.49. We recognize stock-based compensation
expense on an accelerated basis in accordance authoritative guidance, which effectively results in
the recognition of approximately 60% of the total compensation expense for a particular option
within 12 months of its grant date. The increase in stock-based compensation expense in the nine
months ended September 30, 2009 compared to the same period in 2008 is due primarily to the
amortization of prior year grants during the first nine months of 2009 and an increase due to the
grant of restricted stock units during the first nine months of 2009 with no comparable grants
during the same period in 2008. Restricted stock units tend to have a higher associated stock-based
compensation expense as they are valued at the full market price on the day of grant. The decrease
in stock-based compensation expense in the three months ended September 30, 2009 compared to the
same period in 2008 is due primarily to a change in the estimate of the number of options expected
to vest as a result of the resignation of one of our executive officers.
Liquidity and Capital Resources
Since our inception in 1997, we have incurred significant losses and as of September 30, 2009,
we had an accumulated deficit of approximately $192.0 million. We expect our sales, marketing and
administrative expense and research and development expense will continue to grow and, as a result,
we will need to generate significant net sales to increase profitability. To date, our operations
have been funded primarily with proceeds from the sale of our securities.
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. The Notes mature on March 15, 2013.
Cash, cash equivalents and short-term and long-term marketable securities, was $200.2 million
at September 30, 2009 and $223.4 million at December 31, 2008. The decrease was due primarily to
the payments of $10.0 million related to our investment in Progentix, $10.0 million related to
Osteocel milestones and $24.1 million related to our acquisition of Cervitech, offset by cash flow
provided from achieving profitability in 2009.
Net cash provided by operating activities was $32.9 million for the first nine months of 2009
compared to $9.4 million used in operating activities in the same period in 2008, an increase of
$42.3 million in net cash provided by operating activities. The increase in cash provided from
operating activities is from our improved operating results in 2009 as compared to 2008, as well as
improved collections from accounts receivable.
Net cash used in investing activities was $40.6 million in the first nine months of 2009
compared to $164.7 million in the same period in 2008. The decrease in net cash used in investing
activities of $124.1 million is primarily due to the net change of $114.5 million in the cash
provided by the activity in our investment portfolio and to a $12.9 million decrease in capital
asset purchases, offset by an increase of $2.8 million used in cash payments for our acquisitions.
Net cash provided by financing activities was $9.6 million in the first nine months of 2009
compared to $216.6 million in the same period in 2008. The change in net cash provided by financing
activities of $207.0 million is primarily due to the receipt of net proceeds of $208.4 million from
the issuance of convertible debt in March 2008.
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 working capital requirements and of
our capital expenditures for additional loaner assets, our operating results, and
cash used in any future acquisitions. In addition, we expect to incur additional capital
expenditures for leasehold improvements for the new headquarters facility. We have sufficient cash
and investments on hand to finance our operations for the foreseeable future.
24
Contractual Obligations
In addition to the contractual obligations disclosed in our Annual Report on Form 10-K for the
year ended December 31, 2008, the following obligations have been incurred during 2009:
Progentix Investment
On January 13, 2009 (the Investment Date), we completed the purchase of forty percent (40%) of
the capital stock of Progentix Orthobiology, B.V., a company organized under the laws of the
Netherlands (Progentix), from existing shareholders pursuant to a Preferred Stock Agreement for $10
million in cash. Additionally, we, Progentix and the shareholders of Progentix entered into an
Option Purchase Agreement dated January 13, 2009 (the Option Agreement), whereby we may be
obligated, upon the achievement of certain milestones by Progentix within two years, to purchase
the remaining sixty percent (60%) of capital stock of Progentix for $45 million, payable in a
combination of cash or NuVasive common stock at our sole discretion, subject to certain adjustments
(the Remaining Shares). We may also be obligated in the event that Progentix achieves the
milestones contemplated above within the requisite two year period to make additional payments to
Progentix shareholders, excluding NuVasive, of up to an aggregate total of $25 million, payable in
a combination of cash or stock at our sole discretion, upon completion of additional milestones and
dependent on our sales success. We also have the right under the Option Agreement to purchase the
Remaining Shares at any time between the second anniversary of the Option Agreement and the fourth
anniversary of the Option Agreement (the Option Period) for $35 million, payable in a combination
of cash or NuVasive common stock at our sole discretion, and in certain circumstances where we
achieve in excess of a certain annual sales run rate on Progentix products during the Option
Period, we may be required to purchase the Remaining Shares for $35 million. We also entered into a
Distribution Agreement with Progentix dated January 13, 2009, whereby Progentix appointed us as its
exclusive distributor for certain Progentix products. The Distribution Agreement shall remain in
effect for a term of ten years unless earlier terminated in accordance with its terms.
We entered into a Senior Secured Facility Agreement with Progentix dated January 13, 2009 (the
Facility Agreement) whereby Progentix may borrow up to $5 million from us to fund ongoing clinical
and regulatory efforts (the Loan). The Loan accrues interest at a rate of six percent (6%) per
year. The total amount of the Loan and any related accrued interest may be paid in cash or applied
against any potential future purchase price of the Remaining Shares. We are not obligated to
provide any additional funding to Progentix other than as stipulated in the Loan. Progentix
has borrowed $2.0 million under the Loan at September 30, 2009.
Cervitech® Inc. Acquisition
On May 8, 2009, the Company completed the purchase of all of the outstanding shares of
Cervitech, Inc., a Delaware corporation (Cervitech), pursuant to a Share Purchase Agreement dated
April 22, 2009 (the Purchase Agreement) for an initial payment of approximately $48 million
consisting of cash totaling approximately $24 million and the issuance of 638,261 shares of
NuVasive common stock (the Shares) 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.
NuVasive may also be obligated, in the event that Cervitech receives FDA approval of the
device, to make an additional payment of $33 million, payable in either cash or a combination of
cash and up to half in NuVasives common stock, at the Companys election.
Osteocel Biologics Business Acquisition
In connection with the Asset Purchase Agreement and Manufacturing Agreement, each as amended,
that were entered into in connection with the Osteocel Biologics Business Acquisition, we made an
additional milestone-based contingent payment to Osiris in the amount of $15 million related to a
sales performance milestone. This payment was made in NuVasive common stock, at our election.
25
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Item 3. |
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Quantitative and Qualitative Disclosures About Market Risk |
Our exposure to interest rate risk at September 30, 2009 is related to our investment
portfolio which consists largely of debt instruments of high quality corporate issuers and the U.S.
government and its agencies. Due to the short-term nature of these investments, we have 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. At September 30, 2009, we did not hold any material asset-backed investment
securities and in 2009 and 2008, we did not realize any losses related to asset-backed investment
securities.
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 Risk. 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. Currently, a majority of
our sales to international markets have been to independent distributors in transactions conducted
in U.S. dollars; our other sales in international markets, currently the United Kingdom, Germany
and Australia, are through local subsidiaries which sell directly to health care providers in local
currencies. To date, we have not had any material exposure to foreign currency rate fluctuations.
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Item 4. |
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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 September 30, 2009. Based on such
evaluation, our management has concluded that as of September 30, 2009, 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
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, 2008
(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.
26
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Item 2. |
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Unregistered Sales of Equity Securities and Use of Proceeds. |
On
September 30, 2009 and November 6, 2009, NuVasive, Inc.,
issued 307,814 and 400,277 shares
of its common stock (the Shares), respectively, to Osiris Therapeutics, Inc., a Delaware
corporation, in connection with milestone payments pursuant to an Asset Purchase Agreement between
the Company and Osiris dated May 8, 2008, as amended. The Shares were issued to Osiris in reliance
on the exemption from registration under Section 4(2) of the Securities Act of 1933, as amended,
and/or Rule 506 of Regulation D promulgated under the Securities Act.
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Item 5. |
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Other Information |
Compensatory Arrangements with Certain Officers
On November 4, 2009, NuVasive, Inc. (the Company) entered into compensatory letter agreements
with Pat Miles and Jeff Rydin, each a named executive officer (as defined in Item 402(a)(3) of
Regulation S-K) of the Company, in association with their respective promotions, each to be
effective January 1, 2010. Mr. Miles, currently the
Companys Executive Vice President, Product Marketing
and Development, was promoted to the position of President, Americas. Mr. Rydin, currently
the Companys Senior Vice President, U.S. Sales, was promoted to the position of Executive Vice
President, Americas Sales. The letter agreements set forth new base salaries, anticipated
restricted stock unit grants and target performance bonus (upon the achievement of specified
performance milestones) for Mr. Miles and Mr. Rydin as follows:
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2010 RSU Grants |
|
Target Bonus for |
Name |
|
2010 Base Salary |
|
(# of shares) |
|
Fiscal 2010 |
Patrick Miles |
|
$ |
450,000 |
|
|
|
85,000 |
|
|
|
75 |
% |
Jeffrey Rydin |
|
$ |
400,000 |
|
|
|
50,000 |
|
|
|
75 |
% |
Mr. Miles and Mr. Rydin will be eligible to receive a bonus in excess of the target bonus for
over-achievement.
Other Events
Between September 9, 2009 and September 14, 2009, each of the following individuals, each an
executive officer of NuVasive, Inc. (NuVasive), adopted a stock trading plan for trading in
NuVasives common stock in accordance with the guidelines specified by the Securities and Exchange
Commissions Rule 10b5-1 under the Securities Exchange Act of 1934: Keith Valentine, NuVasives
President and Chief Operating Officer; Kevin C. OBoyle, NuVasives Executive Vice President and
Chief Financial Officer; Jeff Rydin, NuVasives Senior Vice President, U.S. Sales; and Jason
Hannon, Nuvasives Senior Vice Present and General Counsel. Each of these individuals will file
Forms 4 evidencing sales under their 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. Valentine, between December 2009 and
November 2010, he will sell 5,000 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.
Pursuant to the stock trading plan adopted by Mr. OBoyle: in December 2009 he will sell 42,977
shares if the stock is above a prearranged minimum price; in January 2010 he will sell 13,871
shares if the stock is above a prearranged minimum price, and may sell up to 68,750 additional
shares based on increasing price levels; in February 2010 he will sell 6,848 shares if the stock
is above a prearranged minimum price, and may sell any shares remaining unsold from the prior month
sale; and in March 2009 he will sell 6,848 shares if the stock is above a prearranged minimum price
and may sell any shares remaining unsold following the prior months sale date. Pursuant to the
stock trading plan adopted by Mr. Rydin: in December 2009 he will sell 4,274 shares if the stock is
above a prearranged minimum price, and may sell up to 3,000 additional shares based on increasing
price levels; between January and April 2010, he will sell 3,000 shares each month if the stock is
above a prearranged minimum price, and may sell up to 3,000 additional shares each month based on
increasing price levels; in May 2010 he will sell 3,640 shares if the stock is above a prearranged
minimum price, and may sell up to 3,000 additional shares based on increasing price levels; and
between June and November 2010 he will sell 3,000 shares each month if the stock is above a
prearranged minimum price, and may sell up to 3,000 additional shares each month based on
increasing price levels based on increasing price levels. Pursuant to the stock trading plan
adopted by Mr. Hannon, between December 2009 and November 2010, he will 2,000 shares each month if
the stock is above a prearranged minimum price, and may sell up to 6,000 additional shares each
month based on increasing price levels.
Under each of these plans, the plans agent will undertake to sell specified numbers of shares
each month if the stock trades above certain prearranged minimum prices. The individual
stockholder will have no control over the timing of any sales under the plan and there is no
assurance that any shares will be sold. Sales under each of these trading plans will take effect
in November 2009 upon the expiration of their existing Rule 10b5-1 trading plans. Mr. OBoyles
plan will expire in March 2010 while all other plans will expire in November 2010.
27
EXHIBIT INDEX
|
|
|
Exhibit No |
|
Description |
|
3.1 (1)
|
|
Restated Certificate of Incorporation |
|
|
|
3.2 (2)
|
|
Restated Bylaws |
|
|
|
10.1#
|
|
Separation Agreement, dated September 2, 2009, between NuVasive, Inc. and Kevin C. OBoyle |
|
|
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31.1
|
|
Certification of Chief Executive Officer pursuant to Rules 13a-14 and 15d-14 promulgated
under the Securities Exchange Act of 1934 |
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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 |
|
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(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. |
|
# |
|
Indicates management contract or compensatory plan. |
|
* |
|
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. |
28
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: November 6, 2009
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By: |
/s/ Alexis V. Lukianov
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Alexis V. Lukianov |
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Chairman and Chief Executive Officer |
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Date: November 6, 2009
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By: |
/s/ Kevin C. OBoyle
|
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Kevin C. OBoyle |
|
|
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Executive Vice President and
Chief Financial Officer |
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29
EXHIBIT INDEX
|
|
|
Exhibit No |
|
Description |
|
3.1 (1)
|
|
Restated Certificate of Incorporation |
|
|
|
3.2 (2)
|
|
Restated Bylaws |
|
|
|
10.1#
|
|
Separation Agreement, dated September 2, 2009, between NuVasive, Inc. and Kevin C. OBoyle |
|
|
|
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 |
|
|
|
(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. |
|
# |
|
Indicates management contract or compensatory plan. |
|
* |
|
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. |
30