e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2008
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)
4545 Towne Centre Court
San Diego, CA 92121
(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 is a large accelerated filer, an accelerated filer,
a non-accelerated filer, or a smaller reporting company.
See the definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act. (Check one):
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Large accelerated filer þ |
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Accelerated filer o |
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Non-accelerated filer o
(Do not check if a smaller reporting company) |
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Smaller Reporting Company o |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act). Yes o No. þ
As of July 31, 2008, there were 35,878,674 shares of the registrants common stock outstanding.
NUVASIVE, INC.
QUARTERLY REPORT ON FORM 10-Q
June 30, 2008
TABLE OF CONTENTS
2
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
NUVASIVE, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
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June 30, 2008 |
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December 31, 2007 |
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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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$ |
136,224 |
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$ |
61,915 |
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Short-term marketable securities |
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72,746 |
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19,247 |
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Accounts receivable, net |
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32,528 |
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27,496 |
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Inventory, net |
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52,185 |
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36,280 |
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Prepaid expenses and other current assets |
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2,947 |
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1,240 |
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Total current assets |
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296,630 |
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146,178 |
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Property and equipment, net of accumulated depreciation |
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64,876 |
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43,538 |
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Intangible assets, net of accumulated amortization |
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25,955 |
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24,496 |
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Long-term marketable securities |
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56,745 |
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8,536 |
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Other assets |
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9,254 |
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2,939 |
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Total assets |
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$ |
453,460 |
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$ |
225,687 |
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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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$ |
20,012 |
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$ |
13,839 |
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Accrued payroll and related expenses |
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10,793 |
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12,075 |
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Royalties payable |
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2,092 |
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2,076 |
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Total current liabilities |
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32,897 |
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27,990 |
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Senior convertible notes |
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230,000 |
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Long-term liabilities |
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590 |
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1,119 |
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Commitments and contingencies |
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Stockholders equity: |
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Common stock, 70,000 shares authorized; and 35,794
and 35,330 issued and outstanding at June 30, 2008
and December 31, 2007, respectively |
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36 |
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35 |
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Additional paid-in capital |
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366,150 |
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364,469 |
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Accumulated other comprehensive income (loss) |
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(84 |
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54 |
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Accumulated deficit |
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(176,129 |
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(167,980 |
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Total stockholders equity |
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189,973 |
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196,578 |
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Total liabilities and stockholders equity |
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$ |
453,460 |
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$ |
225,687 |
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See accompanying notes to unaudited condensed consolidated financial statements.
3
NUVASIVE, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited and in thousands, except per share data)
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Three Months Ended |
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Six Months Ended |
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June 30, |
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June 30, |
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2008 |
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2007 |
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2008 |
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2007 |
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Revenues |
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$ |
57,417 |
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$ |
35,618 |
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$ |
108,601 |
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$ |
68,838 |
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Cost of goods sold |
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9,571 |
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6,710 |
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18,666 |
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12,417 |
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Gross Profit |
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47,846 |
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28,908 |
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89,935 |
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56,421 |
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Operating expenses: |
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Sales, marketing and administrative |
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42,099 |
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28,534 |
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81,416 |
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56,982 |
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Research and development |
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6,426 |
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5,418 |
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13,402 |
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10,762 |
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In-process research and development |
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4,176 |
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Total operating expenses |
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48,525 |
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33,952 |
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98,994 |
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67,744 |
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Interest and other income, net |
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184 |
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1,628 |
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910 |
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3,487 |
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Net loss |
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$ |
(495 |
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$ |
(3,416 |
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$ |
(8,149 |
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$ |
(7,836 |
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Net loss per share: |
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Basic and diluted |
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$ |
(0.01 |
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$ |
(0.10 |
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$ |
(0.23 |
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$ |
(0.23 |
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Weighted average shares basic and diluted |
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35,663 |
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34,654 |
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35,543 |
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34,485 |
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See accompanying notes to unaudited condensed consolidated financial statements.
4
NUVASIVE, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited and in thousands)
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Six Months Ended |
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June 30, |
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2008 |
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2007 |
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Operating activities: |
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Net loss |
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$ |
(8,149 |
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$ |
(7,836 |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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8,449 |
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5,933 |
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Stock-based compensation |
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10,298 |
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6,613 |
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In-process research and development |
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4,176 |
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Other non-cash adjustments |
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312 |
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1,179 |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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(5,044 |
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(4,621 |
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Inventory |
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(16,496 |
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(8,868 |
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Prepaid expenses and other current assets |
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(1,707 |
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(39 |
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Accounts payable and accrued liabilities |
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3,361 |
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1,926 |
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Accrued payroll and related expenses |
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(1,282 |
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(421 |
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Net cash used in operating activities |
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(6,082 |
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(6,134 |
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Investing activities: |
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Cash paid for pedicle screw technology |
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(6,256 |
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Cash paid for acquisition of Radius Medical, LLC |
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(6,970 |
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Purchases of property and equipment |
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(25,686 |
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(8,527 |
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Sales of short-term marketable securities |
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19,300 |
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79,050 |
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Purchases of short-term marketable securities |
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(72,799 |
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(49,580 |
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Sales of long-term marketable securities |
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3,500 |
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6,000 |
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Purchases of long-term marketable securities |
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(51,709 |
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(13,991 |
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Other assets |
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543 |
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5 |
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Net cash (used in) provided by investing activities |
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(133,107 |
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5,987 |
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Financing activities: |
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Payment of long-term liabilities |
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(300 |
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(300 |
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Issuance of senior convertible notes, net of issuance costs |
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222,414 |
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Purchase of convertible note hedges |
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(45,758 |
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Sale of warrants |
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31,786 |
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Issuance of common stock |
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5,356 |
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3,189 |
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Net cash provided by financing activities |
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213,498 |
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2,889 |
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Increase in cash and cash equivalents |
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74,309 |
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2,742 |
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Cash and cash equivalents at beginning of period |
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61,915 |
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41,476 |
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Cash and cash equivalents at end of period |
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$ |
136,224 |
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$ |
44,218 |
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Supplemental disclosure of non-cash transaction: |
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Issuance of common stock in connection with acquisition of
Radius Medical LLC |
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$ |
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$ |
10,501 |
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Purchases of leasehold improvements paid by lessor |
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$ |
2,848 |
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$ |
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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 and operates in one business segment. The Company
began commercializing its products in 2001. NuVasives principal product offering includes a
minimally disruptive surgical platform called Maximum Access Surgery, or MAS®, as well as a growing
offering of cervical and motion preservation products. The Companys currently-marketed products
are used predominantly in spine fusion surgeries, both to enable access to the spine and to perform
restorative and fusion procedures. The Company also focuses significant research and development
efforts on both MAS and motion preservation products in the areas of (i) fusion procedures in the
lumbar and thoracic spine, (ii) cervical fixation products, and (iii) motion preservation products
such as total disc replacement and nucleus-like cervical disc replacement. The Company dedicates
significant resources to sales and marketing efforts, including training spine surgeons on its
unique technology and products. The Companys MAS platform combines NeuroVision®, a nerve avoidance
system, MaXcess®, a minimally disruptive surgical system, and specialized implants, including
fixation products for fusion and CoRoent® suite of implants.
The fusion fixation products include the Companys SpheRx® pedicle screw systems, XLP
lateral fixation plate, Halo anterior fixation plate, Helix cervical plate and Gradient
Plustm cervical plate. The Company also offers their Triad® and Extensure
lines of bone allograft, in patented saline packaging, and a synthetic bone void filler,
FormaGraft®, designed to aid in bone growth with fusion procedures.
The Company loans its NeuroVision systems to surgeons and hospitals who purchase disposables
and implants for use in individual procedures. In addition, NeuroVision, MaXcess and surgical
instrument sets are placed with hospitals for an extended period at no up-front cost to them
provided they commit to minimum monthly purchases of disposables and implants. The Company sells a
small quantity of surgical instrument sets and NeuroVision systems to hospitals. The Company offers
a range of bone allograft in patented saline packaging and spine implants such as rods, plates and
screws. Implants and disposables are shipped from the Companys facilities or from limited
disposable inventories stored at sales agents sites.
NuVasive focuses significant research and development efforts on both MAS and motion
preservation products in the areas of (i) fusion procedures in the lumbar and thoracic spine, (ii)
cervical fixation products, and (iii) motion preservation products such as total disc replacement
and nucleus-like cervical disc replacement. The Company dedicates significant resources to its
sales and marketing efforts, including training spine surgeons on its unique technology and
products.
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 our management, the 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. All intercompany transactions
and balances have been eliminated in consolidation.
These financial statements should be read in conjunction with the audited consolidated
financial statements and notes thereto for the year ended December 31, 2007 included in NuVasives
Annual Report on Form 10-K filed with the Securities and Exchange Commission. Operating results for
the three and six months ended June 30, 2008 and 2007 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, 2007 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.
Certain previously reported amounts have been reclassified to conform to the current periods
presentation.
6
3. Agreement to Acquire Osteocel Biologics Business
On May 8, 2008, NuVasive signed a definitive agreement to acquire the Osteocel® biologics
business from Osiris Therapeutics, Inc. (Osiris). The acquired Osteocel biologics business
includes a proprietary adult stem cell bone graft product with the beneficial properties of
autograft. The Company completed the acquisition of the Osteocel biologics business on July 24,
2008 and made the $35 million cash acquisition closing payment to Osiris. Under the terms of the
agreement, NuVasive will make additional milestone-based contingent payments, which are based on
meeting specific product delivery specifications, not to exceed $37.5 million in either cash or a
combination of cash and stock, at the Companys election. In connection with the closing of the
acquisition, the Company entered into a Manufacturing Agreement (the Manufacturing Agreement),
pursuant to which Osiris will supply, and the Company will purchase, quantities of product of at
least the specified production and performance levels for the specified periods as outlined in the
Manufacturing Agreement. In addition, at the conclusion of the 18 month Manufacturing Agreement,
the Company will obtain a processing facility with significant supply stream capacity from Osiris
for $12.5 million in cash or a combination of cash and stock, at the Companys election.
4. 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
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
thereof 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, subject
to adjustment, at an initial stock price of $44.74 per share, 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 June 30, 2008. The impact of the Hedge is to raise the effective
conversion price of the Notes to approximately $49.13 per share (or approximately 20.3542 shares
per $1,000 principal amount of the Notes). The Hedge is expected to reduce the potential equity
dilution upon conversion of the Notes if the daily volume-weighted average price per share of the
Companys common stock exceeds the strike price of the Hedge. The Warrants could have a dilutive
effect on the Companys earnings per share to the extent that the price of the Companys common
stock during a given measurement period exceeds the strike price of the Warrants. Through June 30,
2008, the price of the Companys common stock has not exceeded the strike price of the Warrants.
5. Acquisition of Pedicle Screw Technology
In March 2008, the Company completed a buy-out of royalty obligations on SpheRx® pedicle screw
and related technology products and acquired new pedicle screw intellectual property totaling $6.3
million. Of the total 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 $4.2
million was allocated to in-process research and development as the associated projects had not yet
reached technological feasibility and had no alternative future uses.
7
6. Balance Sheet Reserves
The balances of the reserves for accounts receivable and inventory are as follows:
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(in thousands) |
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June 30, 2008 |
|
December 31, 2007 |
Reserves for accounts receivable |
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$ |
763 |
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$ |
926 |
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Reserves for inventory |
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$ |
4,104 |
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$ |
3,614 |
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7. Net Loss Per Share
NuVasive computes net loss per share using the weighted-average number of common shares
outstanding during the period. The effect of stock options, conversion of the senior convertible
notes, and warrants is anti-dilutive and therefore excluded from the calculation. Although these
securities are currently not included in the net loss per share calculation, they could be dilutive
when, and if, the Company reports future earnings.
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|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
(in thousands, except per share amounts) |
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Numerator: |
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|
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|
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Net loss |
|
$ |
(495 |
) |
|
$ |
(3,416 |
) |
|
$ |
(8,149 |
) |
|
$ |
(7,836 |
) |
|
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|
|
Denominator for basic and diluted net loss
per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding |
|
|
35,663 |
|
|
|
34,654 |
|
|
|
35,543 |
|
|
|
34,485 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
|
$ |
(0.01 |
) |
|
$ |
(0.10 |
) |
|
$ |
(0.23 |
) |
|
$ |
(0.23 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
8. Comprehensive Income
Comprehensive income, which includes the unrealized gain (loss) on short-term marketable
securities and foreign currency translation adjustments for the three- and six-month periods ended
June 30, 2008 and 2007 did not differ significantly from the reported net loss.
9. Marketable Securities
Effective January 1, 2008, the Company adopted FASB Statement No. 157 (SFAS 157), 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.
On February 6, 2008, the FASB deferred the effective date of SFAS 157 for all nonfinancial assets
and nonfinancial liabilities, except those that are recognized or disclosed at fair value in the
financial statements on a recurring basis. These nonfinancial items include assets and liabilities
such as reporting units measured at fair value in a goodwill impairment test and nonfinancial
assets acquired and liabilities assumed in a business combination. The Company measures certain
assets at fair value and thus there was no impact on the Companys consolidated financial statement
at the adoption of SFAS 157. SFAS 157 requires disclosure that establishes a framework for
measuring fair value and expands disclosure about fair value measurements. The statement requires
fair value measurement 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. |
We measure available-for-sale securities at fair value on a recurring basis. All of the
Companys assets measured at fair value on a recurring basis subject to the disclosure requirements
of SFAS 157 as of June 30, 2008 are categorized as Level 1. The Company recorded an immaterial
unrealized loss in each of the six-month periods ended June 30, 2008 and 2007. The unrealized loss
is included as a component of other comprehensive loss within stockholders equity.
8
10. Stock-Based Compensation
For purposes of calculating the stock-based compensation under SFAS 123(R), the Company
estimates the fair value of stock options granted to employees and shares issued under the Employee
Stock Purchase Plan, or ESPP, using a Black-Scholes option-pricing model. The assumptions used to
estimate the fair value of stock awards granted in the three- and six-month periods ended June 30,
2008 and 2007 are as follows:
|
|
|
|
|
|
|
Three and Six Months |
|
Three and Six Months |
|
|
Ended June 30, 2008 |
|
Ended June 30, 2007 |
Stock Options |
|
|
|
|
Volatility |
|
42% |
|
50% |
Expected term (years) |
|
2.5 to 4.5 |
|
2.5 to 4.5 |
Risk free interest rate |
|
2.46% to 3.41% |
|
4.51% to 4.92% |
Expected dividend yield |
|
0.0% |
|
0.0% |
|
|
|
|
|
ESPP |
|
|
|
|
Volatility |
|
42% to 50% |
|
50% |
Expected term (years) |
|
0.5 |
|
0.5 |
Risk free interest rate |
|
3.03% to 4.01% |
|
4.45% 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 |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
(in thousands, except per share amounts) |
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Sales, marketing and administrative expense |
|
$ |
4,538 |
|
|
$ |
2,894 |
|
|
$ |
9,042 |
|
|
$ |
5,522 |
|
Research and development expense |
|
|
610 |
|
|
|
575 |
|
|
|
1,256 |
|
|
|
1,091 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation expense |
|
$ |
5,148 |
|
|
$ |
3,469 |
|
|
$ |
10,298 |
|
|
$ |
6,613 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect on basic and diluted net loss per share |
|
$ |
(0.14 |
) |
|
$ |
(0.10 |
) |
|
$ |
(0.29 |
) |
|
$ |
(0.19 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation for stock options is recognized and amortized on an accelerated basis
in accordance with Financial Accounting Standards Board Interpretation No. 28, Accounting for Stock
Appreciation Rights and Other Variable Stock Option Award Plans (FIN 28). As of June 30, 2008,
there was $23.8 million of unrecognized stock-based compensation expense. This cost is expected to
be recognized over a weighted-average period of approximately 1.4 years.
11. New Building Lease
On November 6, 2007, the Company entered into a 15-year lease agreement for the purpose of
relocating our corporate headquarters to an approximately 140,000 square feet two-building campus
style complex. Rental payments consist of base rent of $2.43 per square foot per month, escalating
at an annual rate of three percent over the 15-year period of the lease, plus related operating
expenses. In addition, through options to acquire additional space in the project and to require
the construction of an additional building on the campus, the agreement provides for facility
expansion rights to an aggregate of more than 300,000 leased square feet. In connection with the
lease, the Company issued a $3.1 million irrevocable transferrable letter of credit. Relocation to
the new facility began in March 2008 and is expected to continue through the third quarter of 2008.
9
The table below provides the minimum cash payments required under the new building lease for rent
and related operating expenses.
|
|
|
|
|
Year |
|
|
|
|
(in thousands) |
|
|
|
|
2008 |
|
$ |
1,080 |
|
2009 |
|
|
5,151 |
|
2010 |
|
|
5,801 |
|
2011 |
|
|
6,003 |
|
2012 |
|
|
6,214 |
|
2013 and thereafter |
|
|
82,339 |
|
|
|
|
|
|
|
$ |
106,588 |
|
|
|
|
|
12. Business Combination
Radius Acquisition. On January 23, 2007, NuVasive completed the acquisition of substantially
all of Radius Medical, LLCs (Radius) right, title and interest in and to the assets used by Radius
in connection with the design, development, marketing and distribution of collagen-based medical
biomaterials, together with the intellectual property rights, contractual rights, inventories, and
certain liabilities related thereto in exchange for cash consideration of $5.0 million, NuVasive
common stock of $10.5 million, cash deposited in escrow of $2.0 million and direct transaction
costs of $0.3 million. The transaction provides NuVasive with a biologic product,
FormaGraft®, a synthetic bone void filler designed to aid in bone growth with fusion
procedures, and a platform for future development. FormaGraft received 510(k) clearance from the
Food and Drug Administration (FDA) in May 2005. The Company accounted for this acquisition under
the purchase method of accounting and, accordingly, the purchased assets were initially recorded at
their estimated fair values at the date of the acquisition. Among other assets, the Company
acquired $16.5 million of amortizable intangible assets, including a supply agreement with Maxigen
Biotech, Inc. (MBI) and licensed technology and recorded $1.1 million of goodwill. The results of
Radiuss operations are included in the consolidated financial statements beginning on the date of
the acquisition.
In connection with the acquisition of Radius, NuVasive made a separate $2.0 million equity
investment in MBI. On May 1, 2007, the equity investment in MBI was completed resulting in NuVasive
ownership of approximately 9% of MBI. The Company accounts for this investment at cost and includes
it in other assets on the consolidated balance sheets.
13. Impact of Recently Issued Accounting Standards
In December 2007, the Financial Accounting Standards Board (FASB) issued Statement
No. 141(Revised 2007), Business Combinations (SFAS No. 141(R)), which establishes principles and
requirements for the reporting entity in a business combination, including recognition and
measurement in the financial statements of the identifiable assets acquired, the liabilities
assumed, and any non-controlling interest in the acquiree. This statement also establishes
disclosure requirements to enable financial statement users to evaluate the nature and financial
effects of the business combination. SFAS No. 141(R) applies prospectively to business combinations
for which the acquisition date is on or after the beginning of the first annual reporting period
beginning on or after December 15, 2008, and interim periods within those fiscal years. SFAS
No. 141(R) will become effective for our fiscal year beginning in 2009. We are currently evaluating
the effect, if any, the adoption of SFAS No. 141(R) could have on our consolidated financial
statements.
In May 2008, the FASB issued FASB Staff Position (FSP) No. APB 14-1, Accounting for
Convertible Debt Instruments that May be Settled in Cash upon Conversion (Including Partial Cash
Settlement) (FSP APB 14-1 or the FSP) that significantly impacts the accounting for convertible
debt. The FSP requires convertible debt that has the ability to be settled in cash to be bifurcated
into debt and equity components and accounted for separately at issuance. The value assigned to the
debt component would be the estimated fair value, as of the issuance date, of a similar bond
without the conversion feature. The difference between the bond cash proceeds and this estimated
fair value would be recorded as a debt discount and amortized to interest expense over the life of
the bond, resulting in the recognition of interest expense on these securities at an effective rate
more comparable to what the Company would have incurred had the Company issued nonconvertible debt
with otherwise similar terms. The equity component of the convertible debt securities would be
included in the paid-in-capital section of stockholders equity on the Companys consolidated
balance sheets, and the initial carrying values of these debt securities would be
10
correspondingly reduced. The Company is currently evaluating the impact, if any, this FSP
could have on its results of operations upon adoption. In addition, if the Companys convertible
debt is redeemed or converted prior to maturity, any unamortized debt discount at the time of such
redemption or conversion would result in a loss on extinguishment. FSP APB 14-1 will become
effective for fiscal years beginning after December 15, 2008, and require retrospective
application.
11
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 in our Annual Report on Form 10-K for the
year ending December 31, 2007. We do not intend to update these forward looking statements to
reflect future events or circumstances.
Overview
We are a medical device company focused on the design, development and marketing of products
for the surgical treatment of spine disorders. Our currently-marketed product portfolio is focused
on applications for spine fusion surgery, a market estimated to exceed $4.2 billion in the United
States in 2008. Our principal product offering includes a minimally disruptive surgical platform
called Maximum Access Surgery, or MAS®, as well as a growing offering of cervical and motion
preservation products. Our currently-marketed products are used predominantly in spine fusion
surgeries, both to enable access to the spine and to perform restorative and fusion procedures. We
also focus significant research and development efforts on both MAS and motion preservation
products in the areas of (i) fusion procedures in the lumbar and thoracic spine, (ii) cervical
fixation products, and (iii) motion preservation products such as total disc replacement and
nucleus-like cervical disc replacement. We dedicate significant resources to our sales and
marketing efforts, including training spine surgeons on our unique technology and products.
Our MAS platform combines three categories of our product offerings:
|
|
|
NeuroVision® a proprietary software-driven nerve avoidance system; |
|
|
|
|
MaXcess® a unique split-blade design retraction system providing enhanced surgical
access to the spine; and |
|
|
|
|
Specialized implants, including our fixation products for fusion and CoRoent® suite of
implants. |
Our fusion fixation products include our SpheRx® pedicle screw systems, XLP lateral fixation
plate, Halo anterior fixation plate, Helix cervical plate and Gradient Plustm
cervical plate. We also offer our Triad® and Extensure lines of bone allograft, in our
patented saline packaging, and a synthetic bone void filler, FormaGraft®, designed to
aid in bone growth with fusion procedures.
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 particular, we have an ongoing
pivotal clinical study, which began in the third quarter of 2006, with respect to our
investigational cervical disc replacement device. We expect to have completed enrollment in the
trial by August 2008.
Since inception, we have been unprofitable. As of June 30, 2008, we had an accumulated deficit
of $176.1 million.
Revenues. The majority of our revenues are derived from the sale of implants and disposables
and we expect this trend to continue in the near term. We loan our 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. These extended loan
transactions represent less than 20% of our total stock of loaner surgical assets. Our implants and
disposables are currently sold and shipped from our San Diego and Memphis facilities or from
limited disposable inventories stored at our sales agents sites. We recognize revenue for
disposables or implants used upon receiving a purchase order
12
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 June 30, 2008, 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 distribute our products through a sales force comprised of independent exclusive sales
agents and our own directly employed sales professionals. 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. In the second quarter of 2006, we completed our efforts to transition our
sales force to one that is exclusive to us with respect to the sale of spine products. Late in
2007, we began an expansion in international markets focusing initially on European 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, 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.
We believe the following accounting policies to be critical to the judgments and estimates
used in the preparation of our consolidated financial statements.
Revenue Recognition. We follow the provisions of the Securities and Exchange Commission Staff
Accounting Bulletin (SAB) No. 104, Revenue Recognition, which sets forth guidelines for the timing
of revenue recognition based upon factors such as passage of title, installation, payment and
customer acceptance. We recognize revenue when all four of the following criteria are met: (i)
persuasive evidence that an arrangement exists; (ii) delivery of the products and/or services has
occurred; (iii) the selling price is fixed or determinable; and (iv) collectability is reasonably
assured. Specifically, revenue from the sale of implants and disposables is recognized upon receipt
of a purchase order from the hospital indicating product use or implantation or upon shipment to
third party customers who immediately accept title. Revenue from the sale of our instrument sets is
recognized upon receipt of a purchase order and the subsequent shipment to customers who
immediately accept title.
Allowance for Doubtful Accounts. We maintain an allowance for doubtful accounts for estimated
losses resulting from the inability of our customers to make required payments. The allowance for
doubtful accounts is reviewed quarterly and is estimated based on the aging of account balances,
collection history and known trends with current customers. As a result of this review, the
allowance is adjusted on a specific identification basis. Increases to the allowance for doubtful
accounts result in a corresponding sales, marketing and administrative expense. We maintain a
relatively large customer base that mitigates the risk of concentration with one customer. However,
if the overall condition of the healthcare industry were to deteriorate, or if the historical data
used to calculate the allowance provided for doubtful accounts does not reflect our customers
future ability to pay outstanding receivables, significant additional allowances could be required.
Excess and Obsolete Inventory and Instruments. We calculate an inventory reserve for estimated
obsolescence and excess inventory based upon historical turnover and assumptions about future
demand for our products and market conditions. Our allograft implants have a four-year shelf life
and are subject to demand fluctuations based on the availability and demand for alternative implant
products. Our MAS inventory, which consists primarily of disposables and specialized implants, is
at risk of obsolescence following the introduction and development of new or enhanced products. Our
estimates and assumptions for excess and obsolete inventory are reviewed and updated on a quarterly
basis. The estimates we use for demand are also used for near-term capacity planning and inventory
purchasing and are consistent with our revenue forecasts. Increases in the reserve for excess and
obsolete inventory result in a corresponding expense to cost of goods sold.
13
A stated goal of our business is to focus on continual product innovation and to obsolete our
own products. While we believe this provides a competitive edge, it also results in the risk that
our products and related capital instruments will become obsolete prior to the end of their
anticipated useful lives. If we introduce new products or next-generation products prior to the end
of the useful life of a prior generation, we may be required to dispose of existing inventory and
related capital instruments and/or write off the value or accelerate the depreciation of these
assets.
Long-Term Assets. Property and equipment is carried at cost less accumulated depreciation.
Depreciation is computed using the straight-line method based on the estimated useful lives of
three to seven years for machinery and equipment and three years for loaner instruments. We own
land and a building in Memphis, Tennessee that we use as a warehouse and distribution facility. The
building is depreciated over a period of 20 years. Maintenance and repairs are expensed as
incurred. Intangible assets, consisting of purchased and licensed technology and a supply
agreement, are amortized on a straight-line basis over their estimated useful lives ranging from 14
to 20 years.
We evaluate our long-term assets for indications of impairment whenever events or changes in
circumstances indicate that the carrying value may not be recoverable. If this evaluation indicates
that the value of the long-term asset may be impaired, we make an assessment of the recoverability
of the net carrying value of the asset over its remaining useful life. If this assessment indicates
that the long-term asset is not recoverable, we reduce the net carrying value of the related asset
to fair value and may adjust the remaining depreciation or amortization period. We have not
recognized any material impairment losses on long-term intangible assets through June 30, 2008.
Accounting for Income Taxes. Significant management judgment is required in determining our
provision for income taxes, our deferred tax assets and liabilities and any valuation allowance
recorded against our net deferred tax assets. We have recorded a full valuation allowance on our
net deferred tax assets as of June 30, 2008 due to uncertainties related to our ability to utilize
our deferred tax assets in the foreseeable future.
Valuation of Stock-Based Compensation. On January 1, 2006, we adopted the fair value
recognition provisions of Statement of Financial Accounting Standards (SFAS) 123 (revised 2004),
Share-Based Payment (SFAS 123(R)), which establishes accounting for share-based awards exchanged
for shareowner (employee) and non-employee director services and requires us to expense the
estimated fair value of these awards over the requisite service period. Option awards issued to
non-employees are recorded at their fair value as determined in accordance with Emerging Issues
Task Force (EITF) 96-18, Accounting for Equity Instruments That Are Issued to Other Than Employees
for Acquiring, or in Conjunction with Selling Goods or Services, and are periodically revalued as
the options vest and are recognized as expense over the related service period.
For purposes of calculating the stock-based compensation expense, we estimate the fair value
of all share-based awards to shareowners (employees) and directors at the date of grant using the
Black-Scholes option-pricing model and the portion that is ultimately expected to vest is
recognized as compensation expense over the requisite service period on an accelerated basis.
The determination of fair value using the Black-Scholes option-pricing model is affected by
our stock price, as well as assumptions regarding a number of complex and subjective variables,
including expected stock price volatility, risk-free interest rate, expected dividend and expected
term. Stock-based compensation expense is recognized only for those awards that are ultimately
expected to vest, and we have applied an estimated forfeiture rate to unvested awards for the
purpose of calculating compensation cost. Stock-based compensation related to stock options is
recognized and amortized on an accelerated basis in accordance with Financial Accounting Standards
Board Interpretation No. 28, Accounting for Stock Appreciation Rights and Other Variable Stock
Option Award Plans (FIN 28). If there is a difference between the assumptions used in determining
stock-based compensation cost and the actual factors which become known over time, specifically
with respect to anticipated forfeitures, we may change the input factors used in determining
stock-based compensation costs. These changes, if any, may materially impact our results of
operations in the period such changes are made.
In-Process Research and Development. In 2008, we recorded an in-process research and
development (IPRD) charge of $4.2 million related to the acquisition of pedicle screw technology in
the first quarter of 2008. At the date of the acquisition, the projects associated with the IPRD
efforts had not yet reached technological feasibility and the research and development in-process
had no alternative future uses. Accordingly, the amounts were charged to expense on the acquisition
date.
14
The above listing is not intended to be a comprehensive list of all of our accounting
policies. In many cases, the accounting treatment of a particular transaction is specifically
dictated by accounting principles generally accepted in the United States (GAAP). See our unaudited
condensed consolidated financial statements and notes thereto included in this report, and our
audited consolidated financial statements and notes thereto for the year ended December 31, 2007
included in our Annual Report on Form 10-K filed with the Securities and Exchange Commission, which
contain accounting policies and other disclosures required by GAAP.
Results of Operations
Revenue
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
(dollars in thousands) |
|
2008 |
|
2007 |
|
$ Change |
|
% Change |
Three months ended |
|
$ |
57,417 |
|
|
$ |
35,618 |
|
|
$ |
21,799 |
|
|
|
61.2 |
% |
Six months ended |
|
$ |
108,601 |
|
|
$ |
68,838 |
|
|
$ |
39,763 |
|
|
|
57.8 |
% |
Revenues have increased over time due primarily to continued market acceptance of our products
within our MAS platform, including NeuroVision, MaXcess disposables, 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 have 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 through product introductions in 2008 and 2007 have contributed to revenue growth
in both years. Additionally, the completion of our transition to an exclusive sales force in
mid-2006 has increased the effort focused on selling our products, as well as the overall market
penetration, resulting in higher sales. We expect revenue to continue to increase, which can be
mainly 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. In addition, the expansion of our biologics offering through the acquisition
of the Osteocel biologics business, and our new product introductions and sales force initiatives
are expected to lead to continued revenue growth.
Cost of Goods Sold
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
(dollars in thousands) |
|
2008 |
|
2007 |
|
$ Change |
|
% Change |
Three months ended |
|
$ |
9,571 |
|
|
$ |
6,710 |
|
|
$ |
2,861 |
|
|
|
42.6 |
% |
% of revenue |
|
|
16.7 |
% |
|
|
18.8 |
% |
|
|
|
|
|
|
|
|
Six months ended |
|
$ |
18,666 |
|
|
$ |
12,417 |
|
|
$ |
6,249 |
|
|
|
50.3 |
% |
% of revenue |
|
|
17.2 |
% |
|
|
18.0 |
% |
|
|
|
|
|
|
|
|
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 six-month periods ended
June 30, 2008 compared to the same periods in 2007 resulted primarily from (i) increased material
costs of $1.3 million and $5.6 million, respectively, primarily to support revenue growth; (ii)
increased depreciation expense of $0.6 million and $1.1 million, respectively, incurred on the
increased amount of surgical instrument sets we hold for use in surgeries; and (iii) for the
three-months ended June 30, 2008, increased overhead expense of $0.8 million due to expanded
facility costs. We expect cost of goods sold, as a percentage of revenue, to increase slightly
through the remainder of 2008. We expect our gross margin to range between 80% to 81%.
15
Operating Expenses
Sales, Marketing and Administrative.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
(dollars in thousands) |
|
2008 |
|
2007 |
|
$ Change |
|
% Change |
Three months ended |
|
$ |
42,099 |
|
|
$ |
28,534 |
|
|
$ |
13,565 |
|
|
|
47.5 |
% |
% of revenue |
|
|
73.3 |
% |
|
|
80.1 |
% |
|
|
|
|
|
|
|
|
Six months ended |
|
$ |
81,416 |
|
|
$ |
56,982 |
|
|
$ |
24,434 |
|
|
|
42.9 |
% |
% of revenue |
|
|
75.0 |
% |
|
|
82.8 |
% |
|
|
|
|
|
|
|
|
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, 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 in 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 shipping costs, were $ 5.4 million,
and $7.7 million, for the three- and six- month periods ended June 30, 2008, respectively,
compared to the same periods in 2007. Increases in costs based on overall company growth and
administrative support, such as compensation and other shareowner (employee) related costs, were
$3.1 million and $7.7 million, respectively, for the three- and six-month periods ended June 30,
2008, compared to the same periods in 2007. We also incurred an increase in equipment and facility
costs of $1.5 million and $2.2 million, respectively, for the three- and six-month period ended
June 30, 2008, compared to the same period in 2007, also a result of company growth and the
relocation to our new facility.
Total costs related to our sales force, as a percent of revenue, decreased to 32.2% from 33.5%
for the three months ended June 30, 2008 compared to the same period in 2007. The decrease in costs
as a percentage of revenue were primarily attributable to the increased revenues and to certain
costs associated with our transition to sales force exclusivity that were incurred in the 2007
period but not incurred in the 2008 period.
In the second quarter of 2006, we completed our efforts to transition our sales force to one
that is exclusive to us in the field of spine products. Our exclusive sales force consists of
independent sales agents and directly-employed sales personnel. On a long-term basis, as a
percentage of revenue, we expect sales, marketing and administrative costs to continue to decrease
over time as we continue to see the synergies of investments we have made (such as our sales force
exclusivity transition). However, we have other significant expenses planned that are designed to
increase the scalability of our business. For example, we purchased and began the implementation of
a new enterprise resource planning, or ERP, software system, in 2007. We will capitalize the
majority of the aggregate $8.6 million anticipated cost of the ERP project and amortize it over a
7-year period. In addition, we entered into a lease of a two-building campus-style headquarters
complex in November 2007 to accommodate our Companys growth. Relocation to the new facility began
in March 2008 and is expected to be completed in the third quarter of 2008, and, as a result, we
will incur increased facility costs beginning on the relocation dates. Specifically, we expect to
incur approximately $1.9 million in incremental facility costs in 2008 plus an amount related to
our former headquarters, as discussed below. See Note 11 to the unaudited condensed consolidated
financial statements included in this filing for additional information regarding this lease and
the expected additional costs related thereto.
Subsequent to completion of our relocation to the new facility, we expect to sublease the
current 62,000 square foot facility through August 2012, the date on which the related lease
agreement expires. Upon moving the final phase of shareowners (employees) and operations from our
current facility to our new headquarters during the third quarter of 2008, we expect to record a
loss equal to the estimated excess of the remaining lease expense less the expected sublease
income. As a result, we expect to record a one-time loss in the third quarter of 2008 in the range
of $2.0 million to $3.0 million. As of the date of this filing, we have not yet entered into a
sublease agreement and cannot be assured that a sublease, if any, will provide the anticipated
sublease income used to calculate the above range.
16
Research and Development.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
(dollars in thousands) |
|
2008 |
|
2007 |
|
$ Change |
|
% Change |
Three months ended |
|
$ |
6,426 |
|
|
$ |
5,418 |
|
|
$ |
1,008 |
|
|
|
|
|
|
|
18.6 |
% |
% of revenue |
|
|
11.2 |
% |
|
|
15.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
Six months ended |
|
$ |
13,402 |
|
|
$ |
10,762 |
|
|
$ |
2,640 |
|
|
|
|
|
|
|
24.5 |
% |
% of revenue |
|
|
12.3 |
% |
|
|
15.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expense consists primarily of product research and development,
clinical trial costs, regulatory and clinical functions, and employee (shareowner)-related
expenses.
The increase in research and development costs in the periods presented are primarily due to
increases in compensation and other shareowner related expenses of $0.8 million and $1.6 million
for the three- and six-month periods ended June 30, 2008, respectively, compared to the same
periods in 2007, 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; however, as a percentage of revenue these costs are expected to decrease
in the near term and then stabilize over time.
In-Process Research and Development.
The Company completed a buy-out of royalty obligations on SpheRx® pedicle screw and related
technology products and acquired new pedicle screw intellectual property for an aggregate purchase
price of $6.3 million in March 2008. The total purchase price was allocated as $2.1 million to
intangible assets to be amortized on a straight-line basis over a seven-year period and $4.2
million to in-process research and development as the associated projects had not yet reached
technological feasibility. No acquisitions resulting in similar charges occurred during the three-
and six- months ended June 30, 2007.
Interest and Other Income, Net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
(dollars in thousands) |
|
2008 |
|
2007 |
|
$ Change |
|
% Change |
Three months ended |
|
$ |
184 |
|
|
$ |
1,628 |
|
|
$ |
(1,444 |
) |
|
|
(88.7 |
%) |
% of revenue |
|
|
0.3 |
% |
|
|
4.6 |
% |
|
|
|
|
|
|
|
|
Six months ended |
|
$ |
910 |
|
|
$ |
3,487 |
|
|
$ |
(2,577 |
) |
|
|
(73.9 |
%) |
% of revenue |
|
|
0.8 |
% |
|
|
5.1 |
% |
|
|
|
|
|
|
|
|
Interest and other income, 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. For the six months ended June 30, 2007, this category also includes, other
income of $0.4 million related to our relinquishment of a right of first refusal to certain
technology associated with the 2005 acquisition of RSB Spine LLC and other income of $0.3 million
for an insurance claim settlement. Excluding these items, interest and other income, net,
decreased in the periods presented due to (i) $1.7 million and $2.1 million in interest expense for
the three- and six-month periods ended June 30, 2008, respectively, related to the convertible debt
offering, and (ii) higher balances in marketable securities offset by lower interest rates
resulting in an increase of $0.4 million and $0.1 million for the three- and six-month periods
ended June 30, 2008, respectively.
17
Stock-Based Compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
(in thousands) |
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Sales, marketing and administrative expense |
|
$ |
4,538 |
|
|
$ |
2,894 |
|
|
$ |
9,042 |
|
|
$ |
5,522 |
|
Research and development expense |
|
|
610 |
|
|
|
575 |
|
|
|
1,256 |
|
|
|
1,091 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stock-based compensation expense |
|
$ |
5,148 |
|
|
$ |
3,469 |
|
|
$ |
10,298 |
|
|
$ |
6,613 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
We granted approximately 1.6 million and 1.2 million options in the first six months of 2008
and 2007, respectively, with a per option grant date weighted average fair value of $14.22 and
$10.26, respectively. We recognize stock-based compensation expense on a accelerated basis in
accordance with FIN 28, 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
increases in stock-based compensation expense in the three- and six-month periods ended June 30,
2008 compared to the same periods in 2007 are due primarily to additional options granted in the
2008 periods and the increased weighted average fair value per option in 2008, in addition to
increased participation in our Employee Stock Purchase Plan.
Osteocel® Acquisition
On July 24, 2008, we completed the acquisition of the Osteocel® biologics business from Osiris
Therapeutics, Inc. (Osiris) for a closing payment of $35 million. In accordance with the asset
purchase agreement that was entered into during March 2008, we will pay Osiris upon the completion
of production based milestones, based on specified amounts of product delivered to NuVasive, up to
$37.5 million. In addition, in accordance with the asset purchase agreement and a manufacturing
agreement entered into upon the close of the acquisition, we will acquire a manufacturing facility
for $12.5 million, payable in cash or a combination of cash and stock, at our election, in January
2010. At no time will the purchase price of the Osteocel biologics business exceed $85 million. We
are currently in the process of completing our purchase price allocation related to this
acquisition. The total purchase price will be allocated to intangible assets, tangible assets
acquired, and in-process research and development (IPRD), with the excess purchase price allocated
to goodwill. We estimate that we will record a charge to IPRD of approximately $15 to $20 million,
as the associated purchased projects have not yet reached technological feasibility.
Liquidity and Capital Resources
Since our inception in 1997, we have incurred significant losses and as of June 30, 2008, we
had an accumulated deficit of approximately $176.1 million. We have not yet achieved profitability,
and do not expect to be profitable in 2008 after considering the in-process research and
development charge. 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 achieve profitability. To date, our operations have been funded primarily with
proceeds from the sale of our equity 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 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.
Cash, cash equivalents and short-term and long-term marketable securities, was $265.7 million
at June 30, 2008 and $89.7 million at December 31, 2007. The increase was due primarily to the net
proceeds from our convertible debt financing transaction in March of 2008.
Net cash used in operating activities was $6.1 million in the first half of 2008 and 2007. We
spent an incremental $5.9 million for inventory and headcount to support our increased operations
and growing business during the first half of 2008 as compared to the same period in 2007, offset
by improved operating results for the quarter.
Net cash used by investing activities was $133.1 million in the first half of 2008 compared to
$6.0 million provided by investing activities in the same period in 2007. The increase in net cash
used by investing activities of
18
$139.1 million is primarily due to the net change of $123.2 million in the cash used by the
activity in our investment portfolio and to a $17.2 million increase in capital asset purchases.
Included in the $17.2 million increase of capital expenditures over the prior year, is
approximately $3.5 million and $6.6 million of expenditures related to the new facility and for the
implementation of our new ERP system, respectively.
Net cash provided by financing activities was $213.5 million in the first half of 2008
compared to $2.9 million in the same period in 2007. The change in net cash provided by financing
activities of $210.6 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.
Commitments
On November 6, 2007, the Company entered into a 15-year lease agreement for the purpose of
relocating our corporate headquarters to an approximately 140,000 square foot two-building campus
style complex. Rental payments consist of base rent of $2.43 per square foot, escalating at an
annual rate of three percent over the 15-year period of the lease, plus related operating expenses.
Relocation to the new facility began in the first quarter of 2008 and is expected to continue
through the third quarter of 2008. In addition, through options to acquire additional space in the
project and to require the construction of an additional building on the campus, the agreement
provides for facility expansion rights to an aggregate of more than 300,000 leased square feet.
Under the terms of this lease, NuVasive is required to make minimum lease payments, including
operating expenses as follows:
|
|
|
|
|
Year |
|
(in thousands) |
|
2008 |
|
$ |
1,080 |
|
2009 |
|
|
5,151 |
|
2010 |
|
|
5,801 |
|
2011 |
|
|
6,003 |
|
2012 |
|
|
6,214 |
|
2013 and thereafter |
|
|
82,339 |
|
|
|
|
|
|
|
$ |
106,588 |
|
|
|
|
|
In connection with the lease, the Company issued a $3.1 million irrevocable transferrable
letter of credit. Subsequent to the relocation dates, the Company expects to sublease the current
facility through August 2012, the date on which the related lease agreement expires.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
Our exposure to interest rate risk at June 30, 2008 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 June 30, 2008, we did not hold any material asset-backed investment securities
and in 2007 and 2008, we did not realize any losses related to asset-backed investment securities.
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. Further, the majority of
our sales to international markets have been to independent distributors in transactions conducted
in U.S. dollars. Accordingly, we have not had any material exposure to foreign currency rate
fluctuations.
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
19
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 100 basis point 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.
Item 4. Controls and Procedures.
Disclosure Controls and Procedures. We maintain disclosure controls and procedures that are
designed to ensure that information required to be disclosed in our reports under the Securities
Exchange Act of 1934, as amended (Exchange Act), is recorded, processed, summarized and reported
within the timelines specified in the SECs rules and forms, and that such information is
accumulated and communicated to our management, including our Chief Executive Officer and Chief
Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. In
designing and evaluating the disclosure controls and procedures, management recognizes that any
controls and procedures, no matter how well designed and operated, can only provide reasonable
assurance of achieving the desired control objectives, and in reaching a reasonable level of
assurance, management necessarily is required to apply its judgment in evaluating the cost-benefit
relationship of possible controls and procedures.
Under the supervision and with the participation of our management, including our Chief
Executive Officer and our Chief Financial Officer, we carried out an evaluation of the
effectiveness of the Companys disclosure controls and procedures (as such term is defined in
Exchange Act Rules 13a 15(e) and 15d 15(e)) as of June 30, 2008. Based on such evaluation, our
management has concluded as of June 30, 2008, the Companys disclosure controls and procedures are
effective.
Changes in Internal Control over Financial Reporting.
We are involved in ongoing evaluations of internal controls. In anticipation of the filing of
this Form 10-Q, our Chief Executive Officer and Chief Financial Officer, with the assistance of
other members of our management, reviewed our internal controls and have determined, based on such
review, that there have been no changes in internal control over financial reporting during our
most recent fiscal quarter that has materially affected, or is reasonably likely to materially
affect, the Companys internal control over financial reporting.
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
As previously reported, we have been involved in a series of related lawsuits involving families of
decedents who donated their bodies through UCLAs willed body program. We had been dismissed from
these lawsuits by the trial court but the decision was appealed. In July 2008, the appellate court
reversed the trial courts decision to dismiss us from these lawsuits. We are currently deciding
whether to appeal the decision of the appellate court. The complaint alleges that the head of
UCLAs willed body program, Henry G. Reid, and a third party, Ernest V. Nelson, improperly sold
some of the donated cadavers to the defendants (including NuVasive). Plaintiffs only cause of
action against NuVasive is for negligence.
Although the outcome of this lawsuit cannot be determined with certainty, we believe that we acted
within the relevant law in procuring the cadavers for our clinical research and intend to
vigorously defend ourselves against the claims contained in the complaint.
Item 1A. Risk Factors
An investment in our common stock involves a high degree of risk. You should consider
carefully the risks and uncertainties described under Item 1A of Part I of our Annual Report on
Form 10-K filed with the Securities and Exchange Commission for the year ended December 31, 2007,
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
20
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.
If our acquisitions are unsuccessful, our business may be harmed.
As part of our business strategy, we have acquired companies, technologies and product lines
to maintain our objectives of developing or acquiring innovative technologies. Acquisitions involve
numerous risks, including the following:
|
|
|
The possibility that we will pay more than the value we derive from the acquisition,
which could result in future non-cash impairment charges; |
|
|
|
|
Difficulties in integration of the operations, technologies, and products of the
acquired companies, which may require significant attention of our management that
otherwise would be available for the ongoing development of our business; |
|
|
|
|
The assumption of certain known and unknown liabilities of the acquired companies; and |
|
|
|
|
Difficulties in retaining key relationships with employees, customers, partners and
suppliers of the acquired company. |
Any of these factors could have a negative impact on our business, results of operations or
financing position. Specifically, our recent Osteocel acquisition is the largest acquisition we
have ever completed, with a potential total acquisition price of $85 million. If we failed to
properly value that business, or fail to generate expected revenues or profits from operation of
that business, our results of operations will suffer.
Further, past and potential acquisitions entail risks, uncertainties and potential disruptions
to our business, especially where we have little experience as a company developing or marketing a
particular product or technology (as is the case with the Osteocel biologic product). For example,
we may not be able to successfully integrate an acquired companys operations, technologies,
products and services, information systems and personnel into our business, which will be required
if we assume ownership of the Osteocel processing facility. Acquisitions may also further strain
our existing financial and managerial controls, and divert managements attention away from our
other business concerns.
Our recent acquisition of the Osteocel business from Osiris Therapeutics may prove difficult to
successfully integrate and could negatively impact our business.
We recently acquired the Osteocel biologics business from Osiris Therapeutics, Inc. As part
of this acquisition, we inherited the right and obligation to continue supplying the Osteocel
product to the existing primary distributor of Osteocel, Orthofix N.V. Orthofix has an obligation
to purchase a pre-determined amount of Osteocel from us, and our revenue projections for 2008 are
largely dependent on these purchases. We do not have a history of dealing with Orthofix, and any
failure of Orthofix to meet their contractual obligations will negatively impact our results of
operations.
In addition, as part of the acquisition, Osiris will continue to act as our exclusive supplier
of Osteocel for a period of 18 months. In that capacity, we will be highly dependent on Osiris for
supply of Osteocel and any failure on their part to process and supply such product will negatively
impact our ability to meet our obligations to existing distributors and to build inventory for
future launch of our own sales.
The Osteocel product is processed from allograft, which is donated human tissue. Allograft is
a supply-constrained material and there is ongoing risk that there will be insufficient supply to
produce the necessary quantity of Osteocel. Allograft also carries with it the possibility of
disease transmission, which could result in negative patient outcomes and negative publicity for
our company.
Lastly, Orthofix unsuccessfully attempted to stop our acquisition of Osteocel by seeking a
temporary restraining order to delay the acquisition. Although this attempt failed, it is possible
that Orthofix will take further legal action to disrupt the acquisition or integration of the
product, and may specifically assert that it has rights to Osteocel beyond 2008. If Orthofix
attempts to assert any of these claims, such claims could result in fees related to litigation,
settlement or judgment, which fees could negatively impact our results of operations.
21
Item 4. Submission of Matters to a Vote of Security Holders
Our Annual Meeting of Stockholders was held on May 22, 2008. Our stockholders acted upon the
following two proposals at the meeting:
1. To elect two Class I directors to hold office until the 2011 Annual Meeting of
Stockholders and until their successors are elected and qualified.
2. To ratify the appointment of Ernst & Young LLP as the Companys independent registered
public accounting firm for the fiscal year ending December 31, 2008.
With respect to the first proposal, our stockholders voted and approved the election of two
Class I directors to hold office until the 2011 Annual Meeting of Stockholders or until their
earlier resignation or removal. The directors elected and the votes cast were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
Names of Directors Elected |
|
Number of Shares: |
|
For |
|
Withheld |
|
Robert J. Hunt: |
|
|
|
|
|
|
31,726,310 |
|
|
|
1,200,147 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hansen A Yuan: |
|
|
|
|
|
|
31,724,376 |
|
|
|
1,202,081 |
|
The following are the other members of our board of directors whose terms continued after
the meeting: Alexis Lukianov; Jack R. Blair; Peter C. Farrell; Lesley H. Howe; and Eileen M. More.
At the Annual Meeting, our stockholders also voted upon and ratified the Audit
Committees selection of Ernst & Young LLP as the Companys independent registered public
accounting firm for the fiscal year ending December 31, 2008, by the following vote:
Number of Shares Voted
|
|
|
|
|
|
|
For |
|
Against |
|
Abstain |
|
Broker Non-Votes |
|
32,889,963
|
|
25,714
|
|
10,780
|
|
0 |
22
Item 5. Other Information.
Compensatory Arrangements with Certain Officers
On August 5, 2008, the Company entered into compensatory letter agreements (Compensatory
Letter Agreements) with its named executive officers (as defined in Item 402(a)(3) of
Regulation S-K). Each agreement with the applicable named executive officer supersedes all prior
agreements with such named executive officer relating to compensation.
The base salaries and the target bonuses for the named executive officers, as set forth in the
Compensatory Letter Agreements, are consistent with the base salaries and target bonuses disclosed
in the Companys 8-K dated January 4, 2008 and the Companys 8-K dated February 26, 2008,
respectively.
The Compensatory Letter Agreements also set forth the severance benefits for each of the named
executive officers when involuntarily terminated by the Company. The terms of the severance
benefits are summarized as follows:
|
|
|
|
|
|
|
Involuntary Termination Prior to Change |
|
|
|
|
of Control or 12 Months or More After |
|
Involuntary Termination within |
Position |
|
Change of Control |
|
12 Months of a Change of Control |
Alexis V. Lukianov |
|
200% of Compensation |
|
200% of Compensation |
CEO |
|
|
|
|
|
|
|
|
|
Keith C. Valentine |
|
100% of Compensation |
|
150% of Compensation |
President & Chief Operating Officer |
|
|
|
|
|
|
|
|
|
Kevin C. OBoyle |
|
100% of Compensation |
|
150% of Compensation |
Executive Vice President & CFO |
|
|
|
|
|
|
|
|
|
Patrick Miles |
|
100% of Compensation |
|
150% of Compensation |
Executive Vice President,
Marketing & Product Development |
|
|
|
|
|
|
|
|
|
Jeffrey P. Rydin |
|
100% of Compensation |
|
100% of Compensation |
Senior Vice President, U.S. Sales |
|
|
|
|
The terms Change of Control, Compensation, and Involuntary Termination are defined in
the respective Compensatory Letter Agreements. Additionally, upon a Change of Control, the
outstanding options for each named executive officer will have accelerated vesting schedules as set
forth in the respective Compensatory Letter Agreement. Copies of the Compensatory Letter Agreements
are furnished as Exhibits 10.1, 10,2, 10.3, 10.4 and 10.5 and are hereby incorporated herein by
reference.
23
Item 6. Exhibits
EXHIBIT INDEX
|
|
|
Exhibit No |
|
Description |
|
|
|
2.1
|
|
Asset Purchase Agreement, dated May 8, 2008, by and between the
Company and Osiris Therapeutics, Inc. |
|
|
|
3.1 (1)
|
|
Restated Certificate of Incorporation |
|
|
|
3.2 (1)
|
|
Restated Bylaws |
|
|
|
10.1#
|
|
Compensation Letter Agreement, dated August 5, 2008, by and
between the Company and Alexis V. Lukianov |
|
|
|
10.2#
|
|
Compensation Letter Agreement, dated August 5, 2008, by and
between the Company and Keith C. Valentine |
|
|
|
10.3#
|
|
Compensation Letter Agreement, dated August 5, 2008, by and
between the Company and Kevin C. OBoyle |
|
|
|
10.4#
|
|
Compensation Letter Agreement, dated August 5, 2008, by and
between the Company and Patrick Miles |
|
|
|
10.5#
|
|
Compensation Letter Agreement, dated August 5, 2008, by and
between the Company and Jeffrey P. Rydin |
|
|
|
10.6
|
|
Form of Voting Agreement, dated May 8, 2008, by and among each
of Peter Friedli, Venturetec, Inc., U.S. Venture 05, Inc.,
Joyce, Ltd. and C Randal Mills, Ph.D, and the Company |
|
|
|
10.7+
|
|
Manufacturing Agreement, dated July 24, 2008 by and between the
Company and Osiris Therapeutics, Inc. |
|
|
|
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 Securities and
Exchange Commission on August 13, 2004. |
|
# |
|
Indicates management contract or compensatory plan. |
|
+ |
|
Confidential portions omitted and filed separately with the U.S. Securities and Exchange
Commission pursuant to Rule 24b-2 promulgated under the Securities Exchange Act of 1934, as
amended. |
|
* |
|
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. |
24
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
|
NuVasive, Inc. |
|
|
|
|
|
Date: August 8, 2008 |
|
|
|
|
|
|
|
By: /s/ Alexis V. Lukianov |
|
|
Alexis V. Lukianov
Chairman and Chief Executive Officer |
|
|
|
Date: August 8, 2008 |
|
|
|
|
|
|
|
By: /s/ Kevin C. OBoyle |
|
|
Kevin C. OBoyle
Executive Vice President and Chief Financial Officer |
25
EXHIBIT INDEX
|
|
|
Exhibit No |
|
Description |
|
|
|
2.1
|
|
Asset Purchase Agreement, dated May 8, 2008, by and between the
Company and Osiris Therapeutics, Inc. |
|
|
|
3.1 (1)
|
|
Restated Certificate of Incorporation |
|
|
|
3.2 (1)
|
|
Restated Bylaws |
|
|
|
10.1#
|
|
Compensation Letter Agreement, dated August 5, 2008, by and
between the Company and Alexis V. Lukianov |
|
|
|
10.2#
|
|
Compensation Letter Agreement, dated August 5, 2008, by and
between the Company and Keith C. Valentine |
|
|
|
10.3#
|
|
Compensation Letter Agreement, dated August 5, 2008, by and
between the Company and Kevin C. OBoyle |
|
|
|
10.4#
|
|
Compensation Letter Agreement, dated August 5, 2008, by and
between the Company and Patrick Miles |
|
|
|
10.5#
|
|
Compensation Letter Agreement, dated August 5, 2008, by and
between the Company and Jeffrey P. Rydin |
|
|
|
10.6
|
|
Form of Voting Agreement dated as of May 8, 2008 by and among
each of Peter Friedli, Venturetec, Inc., U.S. Venture 05, Inc.,
Joyce, Ltd. and C Randal Mills, Ph.D, and the Company |
|
|
|
10.7+
|
|
Manufacturing Agreement, dated July 24, 2008 by and between the
Company and Osiris Therapeutics, Inc. |
|
|
|
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 Securities and
Exchange Commission on August 13, 2004. |
|
# |
|
Indicates management contract or compensatory plan. |
|
+ |
|
Confidential portions omitted and filed separately with the U.S. Securities and Exchange
Commission pursuant to Rule 24b-2 promulgated under the Securities Exchange Act of 1934, as
amended. |
|
* |
|
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. |
26