e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
|
|
|
þ |
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2011
OR
|
|
|
o |
|
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)
|
|
|
Delaware
|
|
33-0768598 |
(State or other jurisdiction of
|
|
(I.R.S. Employer |
incorporation or organization)
|
|
Identification No.) |
7475 Lusk Boulevard
San Diego, CA 92121
(Address of principal executive offices, including zip code)
(858) 909-1800
(Registrants telephone number, including area code)
(Former name, former address and former fiscal year, if changed since last report)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.
Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate website, if any, every Interactive Data File required to be submitted and posted pursuant
to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the
registrant was required to submit and post such files).
Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the
Exchange Act. (Check one):
|
|
|
|
|
|
|
Large accelerated filer þ
|
|
Accelerated filer o
|
|
Non-accelerated filer o
|
|
Smaller reporting company o |
|
|
|
|
(Do not check if a smaller reporting company) |
|
|
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 29, 2011, there were 39,880,439 shares of the registrants common stock outstanding.
NUVASIVE, INC.
QUARTERLY REPORT ON FORM 10-Q
June 30, 2011
TABLE OF CONTENTS
2
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
NUVASIVE, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except par value)
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
2011 |
|
2010 |
|
|
(Unaudited) |
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
505,084 |
|
|
$ |
92,597 |
|
Short-term marketable securities |
|
|
14,545 |
|
|
|
86,458 |
|
Accounts receivable, net |
|
|
80,532 |
|
|
|
76,632 |
|
Inventory |
|
|
117,952 |
|
|
|
107,577 |
|
Deferred tax assets |
|
|
4,425 |
|
|
|
4,425 |
|
Prepaid expenses and other current assets |
|
|
4,724 |
|
|
|
4,082 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
727,262 |
|
|
|
371,771 |
|
Property and equipment, net |
|
|
115,566 |
|
|
|
102,165 |
|
Long-term marketable securities |
|
|
4,603 |
|
|
|
50,635 |
|
Intangible assets, net |
|
|
101,435 |
|
|
|
107,121 |
|
Goodwill |
|
|
103,070 |
|
|
|
103,070 |
|
Deferred tax assets, non-current |
|
|
52,033 |
|
|
|
52,033 |
|
Restricted cash and investments |
|
|
68,613 |
|
|
|
5,529 |
|
Convertible note hedge derivative |
|
|
80,098 |
|
|
|
|
|
Other assets |
|
|
20,245 |
|
|
|
9,705 |
|
|
|
|
|
|
|
|
Total assets |
|
$ |
1,272,925 |
|
|
$ |
802,029 |
|
|
|
|
| |
|
|
LIABILITIES AND STOCKHOLDERS EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
$ |
52,447 |
|
|
$ |
58,995 |
|
Accrued payroll and related expenses |
|
|
15,356 |
|
|
|
17,266 |
|
Acquisition-related liabilities |
|
|
33,955 |
|
|
|
32,715 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
101,758 |
|
|
|
108,976 |
|
Senior Convertible Notes |
|
|
543,696 |
|
|
|
230,000 |
|
Embedded conversion derivative |
|
|
88,900 |
|
|
|
|
|
Long-term acquisition-related liabilities |
|
|
|
|
|
|
326 |
|
Deferred tax liabilities |
|
|
3,685 |
|
|
|
3,685 |
|
Other long-term liabilities |
|
|
12,670 |
|
|
|
12,810 |
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
Noncontrolling interests |
|
|
11,138 |
|
|
|
11,877 |
|
Stockholders equity: |
|
|
|
|
|
|
|
|
Preferred stock, $0.001 par value; 5,000 shares authorized, none outstanding |
|
|
|
|
|
|
|
|
Common stock, $0.001 par value; 70,000 shares authorized, 39,867 and 39,528
issued and outstanding at June 30, 2011 and December 31, 2010, respectively |
|
|
40 |
|
|
|
40 |
|
Additional paid-in capital |
|
|
613,016 |
|
|
|
545,114 |
|
Accumulated other comprehensive income |
|
|
1,698 |
|
|
|
616 |
|
Accumulated deficit |
|
|
(103,676 |
) |
|
|
(111,415 |
) |
|
|
|
|
|
|
|
Total stockholders equity |
|
|
511,078 |
|
|
|
434,355 |
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity |
|
$ |
1,272,925 |
|
|
$ |
802,029 |
|
|
|
|
|
|
|
|
See accompanying notes to unaudited condensed consolidated financial statements.
3
NUVASIVE, INC.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(in thousands, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
| |
June 30, | |
|
|
2011 |
|
2010 |
|
2011 |
|
2010 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
$ |
132,966 |
|
|
$ |
119,584 |
|
|
$ |
257,432 |
|
|
$ |
228,671 |
|
Cost of goods sold (excluding amortization of purchased technology) |
|
|
25,508 |
|
|
|
21,014 |
|
|
|
49,034 |
|
|
|
40,457 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
107,458 |
|
|
|
98,570 |
|
|
|
208,398 |
|
|
|
188,214 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales, marketing and administrative |
|
|
84,323 |
|
|
|
77,726 |
|
|
|
168,543 |
|
|
|
152,387 |
|
Research and development |
|
|
10,258 |
|
|
|
11,205 |
|
|
|
21,027 |
|
|
|
21,904 |
|
Amortization of intangible assets |
|
|
1,395 |
|
|
|
1,355 |
|
|
|
2,737 |
|
|
|
2,705 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
95,976 |
|
|
|
90,286 |
|
|
|
192,307 |
|
|
|
176,996 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other expense, net: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
151 |
|
|
|
178 |
|
|
|
334 |
|
|
|
367 |
|
Interest expense |
|
|
(1,915 |
) |
|
|
(1,668 |
) |
|
|
(3,686 |
) |
|
|
(3,337 |
) |
Other income (expense), net |
|
|
80 |
|
|
|
(30 |
) |
|
|
577 |
|
|
|
87 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total interest and other expense, net |
|
|
(1,684 |
) |
|
|
(1,520 |
) |
|
|
(2,775 |
) |
|
|
(2,883 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income tax expense |
|
|
9,798 |
|
|
|
6,764 |
|
|
|
13,316 |
|
|
|
8,335 |
|
Income tax expense |
|
|
4,776 |
|
|
|
574 |
|
|
|
6,316 |
|
|
|
1,439 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated net income |
|
$ |
5,022 |
|
|
$ |
6,190 |
|
|
$ |
7,000 |
|
|
$ |
6,896 |
|
|
|
|
|
|
|
| |
|
| |
|
|
Net loss attributable to noncontrolling interests |
|
$ |
(358 |
) |
|
$ |
(533 |
) |
|
$ |
(739 |
) |
|
$ |
(915 |
) |
|
|
|
|
|
|
| |
|
| |
|
|
Net income attributable to NuVasive, Inc. |
|
$ |
5,380 |
|
|
$ |
6,723 |
|
|
$ |
7,739 |
|
|
$ |
7,811 |
|
|
|
|
|
|
|
| |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income per share attributable to NuVasive, Inc.: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.14 |
|
|
$ |
0.17 |
|
|
$ |
0.19 |
|
|
$ |
0.20 |
|
|
|
|
|
|
|
| |
|
| |
|
|
Diluted |
|
$ |
0.13 |
|
|
$ |
0.17 |
|
|
$ |
0.19 |
|
|
$ |
0.19 |
|
|
|
|
|
|
|
| |
|
| |
|
|
Weighted average shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
39,786 |
|
|
|
39,242 |
|
|
|
39,701 |
|
|
|
39,071 |
|
|
|
|
|
|
|
| |
|
| |
|
|
Diluted |
|
|
40,868 |
|
|
|
40,694 |
|
|
|
40,691 |
|
|
|
40,383 |
|
|
|
|
|
|
|
| |
|
| |
|
|
See accompanying notes to unaudited condensed consolidated financial statements.
4
NUVASIVE, INC.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
June 30, | |
|
|
2011 |
|
2010 |
|
|
|
| |
|
|
Operating activities: |
|
|
|
|
|
|
|
|
Consolidated net income |
|
$ |
7,000 |
|
|
$ |
6,896 |
|
Adjustments to reconcile net income to net cash provided by operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
15,888 |
|
|
|
17,065 |
|
Stock-based compensation |
|
|
15,671 |
|
|
|
13,983 |
|
Allowance for excess and obsolete inventory |
|
|
2,341 |
|
|
|
906 |
|
Allowance for doubtful accounts and sales return reserves, net of write-offs |
|
|
529 |
|
|
|
(1,007 |
) |
Accretion of contingent consideration |
|
|
914 |
|
|
|
182 |
|
Other non-cash adjustments |
|
|
2,893 |
|
|
|
2,591 |
|
Changes in operating assets and liabilities, net of effects from acquisitions: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
(5,351 |
) |
|
|
(8,514 |
) |
Inventory |
|
|
(12,146 |
) |
|
|
(4,258 |
) |
Prepaid expenses and other current assets |
|
|
(791 |
) |
|
|
(1,397 |
) |
Accounts payable and accrued liabilities |
|
|
(2,300 |
) |
|
|
4,128 |
|
Accrued payroll and related expenses |
|
|
(1,997 |
) |
|
|
(5,574 |
) |
Income taxes payable |
|
|
5,043 |
|
|
|
460 |
|
|
|
|
| |
|
|
Net cash provided by operating activities |
|
|
27,694 |
|
|
|
25,461 |
|
Investing activities: |
|
|
|
|
|
|
|
|
Purchases of property and equipment |
|
|
(27,944 |
) |
|
|
(22,059 |
) |
Purchases of marketable securities |
|
|
(54,317 |
) |
|
|
(95,015 |
) |
Sales of marketable securities |
|
|
113,559 |
|
|
|
88,028 |
|
Purchases of restricted investments |
|
|
(4,701 |
) |
|
|
|
|
Payment for specific rights in connection with supply agreement, net of refund received |
|
|
(5,000 |
) |
|
|
|
|
|
|
|
| |
|
|
Net cash provided by (used in) investing activities |
|
|
21,597 |
|
|
|
(29,046 |
) |
Financing activities: |
|
|
|
|
|
|
|
|
Proceeds from the sale of warrants |
|
|
47,898 |
|
|
|
|
|
Proceeds from the issuance of convertible debt, net of issuance costs |
|
|
391,548 |
|
|
|
|
|
Purchase of convertible note hedges |
|
|
(80,097 |
) |
|
|
|
|
Proceeds from the issuance of common stock |
|
|
4,334 |
|
|
|
11,963 |
|
Other assets |
|
|
(557 |
) |
|
|
1,369 |
|
Tax benefits related to stock-based compensation awards |
|
|
|
|
|
|
(7,481 |
) |
|
|
|
| |
|
|
Net cash provided by financing activities |
|
|
363,126 |
|
|
|
5,851 |
|
Effect of exchange rate changes on cash |
|
|
70 |
|
|
|
(166 |
) |
|
|
|
| |
|
|
Increase in cash and cash equivalents |
|
|
412,487 |
|
|
|
2,100 |
|
Cash and cash equivalents at beginning of period |
|
|
92,597 |
|
|
|
65,413 |
|
|
|
|
| |
|
|
Cash and cash equivalents at end of period |
|
$ |
505,084 |
|
|
$ |
67,513 |
|
|
|
|
| |
|
|
See accompanying notes to unaudited condensed consolidated financial statements.
5
NuVasive, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements
1. Description of Business and Basis of Presentation
Description of Business
NuVasive®, Inc. (the Company or NuVasive) was incorporated in Delaware on July 21, 1997. The
Company is focused on developing minimally disruptive surgical products and procedures for the
spine. The Company began commercializing its products in 2001. Its currently-marketed product
portfolio is focused on applications for spine fusion surgery. Its principal product offering
includes a minimally disruptive surgical platform called Maximum Access Surgery, or MAS®, as well
as a growing offering of biologics, cervical and motion preservation products. In the spine surgery
market, the Companys currently-marketed products are primarily used to enable access to the spine
and to perform restorative and fusion procedures in a minimally disruptive fashion. The Company
also focuses significant research and development efforts on expanding its MAS product platform,
advancing the applications of their unique technology to additional procedures, and developing
motion preservation products. The Company dedicates significant resources toward training spine
surgeons on its unique technology and products.
The Companys primary business model is to loan its MAS systems to surgeons and hospitals who
purchase disposables and implants for use in individual procedures. In addition, for larger
customers, the Companys proprietary nerve monitoring systems, MaXcess® and surgical instrument
sets are placed with hospitals for an extended period at no up-front cost to them. The Company also
offers a range of bone allograft in patented saline packaging, disposables and spine implants,
which include its branded CoRoent® products and fixation devices such as rods, plates and screws.
Implants and disposables are shipped from the Companys inventories. The Company sells an
immaterial quantity of MAS instrument sets, MaXcess and nerve monitoring systems to hospitals.
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared
pursuant to the rules and regulations of the Securities and Exchange Commission (SEC). Pursuant to
these rules and regulations, the Company has condensed or omitted certain information and footnote
disclosures it normally includes in its annual consolidated financial statements prepared in
accordance with accounting principles generally accepted in the United States (GAAP). In the
opinion of management, the consolidated financial statements include all adjustments necessary,
which are of a normal and recurring nature, for the fair presentation of the Companys financial
position and of the results of operations and cash flows for the periods presented.
The accompanying unaudited condensed consolidated financial statements as of December 31, 2010
and for the three and six months ended June 30, 2011 and 2010 include the accounts of the Company
and its wholly owned subsidiaries, as well as the accounts of a variable interest entity, Progentix
Orthobiology, B.V. (Progentix), which is consolidated pursuant to existing guidance issued by the
Financial Accounting Standards Board (FASB). All significant intercompany accounts and transactions
have been eliminated in consolidation.
These financial statements should be read in conjunction with the audited consolidated
financial statements and notes thereto for the year ended December 31, 2010 included in NuVasives
Annual Report on Form 10-K filed with the SEC. Operating results for the three and six months ended
June 30, 2011 are not necessarily indicative of the results that may be expected for any other
interim period or for the full year. The balance sheet at December 31, 2010 has been derived from
the audited financial statements at that date, but does not include all of the information and
footnotes required by GAAP for complete financial statements.
Change in Accounting Estimate
During the first quarter of 2011, the Company completed a review of the estimated useful life
of its surgical instrument sets. Based on historical useful life information, as well as forecasted
product life cycles and demand expectations, the useful life of certain surgical instrument sets
was extended from three to four years. In accordance with authoritative guidance, this was
accounted for as a change in accounting estimate and was made on a prospective basis effective
January 1, 2011. For the three and six months ended June 30, 2011, depreciation expense, which is
included in sales, marketing and administrative expenses, was lower by approximately
$2.1 million and $3.8 million, respectively, than it would have been had the useful life of
these assets not been extended. The effect of this change on basic and diluted earnings per share
for the three and six months ended June 30, 2011 was $0.03 and $0.05 per share, respectively.
6
Reclassifications and Adjustments
Certain reclassifications have been made to the prior year condensed consolidated financial statements
to conform to the current year presentation.
During the three months ended June 30, 2011, the Company
identified an immaterial error in the consolidated financial
statements for the year ended December 31, 2010 related to the accrual of payroll expenses.
Based on a quantitative and qualitative analysis of the error as required by authoritative guidance, management concluded that
the correction, which increased expenses by approximately $1.3 million in the three and six months ended
June 30, 2011, had no material impact on any of the Companys previously issued financial statements, would
be immaterial to the expected full year results for 2011 and had no effect on the trend of financial results. Of the $1.3
million, approximately $1.0 million and $0.3 million was charged to sales, marketing and
administrative expenses and research and development expenses, respectively.
2. Significant Accounting Policies
Derivative Financial Instruments
On June 28, 2011, the Company issued $402.5 million principal amount of 2.75% Senior
Convertible Notes due 2017 (the 2017 Notes). The 2017 Notes may be settled only in cash unless
stockholder approval is obtained to increase the number of the Companys authorized shares of
common stock. If such approval is obtained, the Company may settle the 2017 Notes in cash, stock,
or a combination thereof. In
accordance with authoritative guidance, the cash conversion feature of the 2017 Notes (the 2017
Notes Embedded Conversion Derivative) requires bifurcation from the 2017 Notes and is accounted for
as a derivative liability, which is included in long-term liabilities in the Companys condensed
consolidated balance sheet.
In connection with the issuance of the 2017 Notes, the Company entered into convertible note
hedge transactions (the 2017 Hedge) entitling the Company, assuming stockholder approval is
obtained to increase the number of the Companys authorized shares of common stock as discussed
above, to purchase up to 9,553,096 shares of the Companys common stock at an initial stock price
of $42.13 per share, each of which is subject to adjustment. Until stockholder approval is obtained
to increase the number of the Companys authorized shares of common stock, the 2017 Hedge may be
settled only in cash. In accordance with authoritative guidance, the 2017 Hedge is accounted for
as a derivative asset, which is included in long-term assets in the Companys condensed
consolidated balance sheet.
The Company recognizes all derivative instruments as assets or liabilities in its balance
sheet and measures these instruments at fair value by marking-to-market these assets and
liabilities at the end of each reporting period. Gains and losses are recorded as a component of
Other income (expense), net. As the fair values of the 2017 Notes Embedded Conversion Derivative
and the 2017 Hedge on June 28, 2011 approximate their respective fair values as of June 30, 2011,
no such gains or losses were recorded for the three and six months ended June 30, 2011.
Recently Adopted Accounting Standards
Fair Value Measurements Disclosures
Effective January 1, 2011, the Company adopted the FASBs updated guidance related to fair
value measurements and disclosures, which requires a reporting entity to disclose separately
information related to purchases, sales, issuances, and settlements in the reconciliation for fair
value measurements using significant unobservable inputs, or Level 3, to be included in the
rollforward of activity. The guidance is effective for interim or annual financial reporting
periods beginning after December 15, 2010. The Company has updated its disclosures to comply with
the updated guidance; however, adoption of the updated guidance did not have an impact on the
Companys consolidated results of operations or financial position.
7
3. Investment in Progentix Orthobiology, B.V.
In 2009, the Company completed the purchase of forty percent (40%) of the capital stock of
Progentix, a company organized under the laws of the Netherlands, from existing shareholders (the
Progentix Shareholders) pursuant to a Preferred Stock Purchase Agreement for $10 million in cash
(the Initial Investment). Concurrent with the Initial Investment, NuVasive and Progentix also
entered into a Senior Secured Facility Agreement, whereby Progentix may borrow up to $5 million
from NuVasive to fund ongoing clinical and regulatory efforts (the Loan). At June 30, 2011, the
Company had advanced Progentix the full $5.0 million in accordance with the Loan Agreement. The
Loan accrues interest at a rate of six percent (6%) per year. Other than its obligations under the
Loan Agreement, NuVasive is not obligated to provide additional funding, nor has any additional
funding been provided, to Progentix.
Also concurrent with the Preferred Stock Purchase Agreement, NuVasive, Progentix and the
Progentix Shareholders entered into an Option Purchase Agreement, as amended (the Option
Agreement), whereby NuVasive may be obligated (the Put Option), upon the achievement of an annual
sales run rate on Progentix products in excess of a specified amount between June 14, 2011 and June
13, 2013 (the Option Period), to purchase the remaining sixty percent (60%) of capital stock of
Progentix from its shareholders (the Remaining Shares) for an amount up to $35.0 million, subject
to certain adjustments, payable in a combination of cash and NuVasive
common stock, at NuVasives
sole discretion. In accordance with the Option Agreement, NuVasive has the right to
purchase the Remaining Shares (the Call Option) during the Option Period for an amount up to $35.0
million, subject to certain adjustments, payable in a combination of cash and NuVasive common
stock, at NuVasives sole discretion. Also in accordance with the Option Agreement, an option
expired in June 2011 that could have required NuVasive to purchase the Remaining Shares and make
additional milestone related payments totaling up to $70 million, subject to certain adjustments.
NuVasive and Progentix also entered into a Distribution Agreement, as amended, whereby Progentix
appointed NuVasive as its exclusive distributor for certain Progentix products. The Distribution
Agreement will be in effect for a term of ten years unless terminated earlier in accordance with
its terms.
In accordance with authoritative guidance issued by the FASB, the Company has determined that
Progentix is a variable interest entity (VIE) as it does not have the ability to finance its
activities without additional subordinated financial support and its equity investors will not
absorb their proportionate share of expected losses and will be limited in the receipt of the
potential residual returns of Progentix. Additionally, pursuant to this guidance, NuVasive is
considered its primary beneficiary as NuVasive has both (1) the power to direct the economically
significant activities of Progentix and (2) the obligation to absorb losses of, or the right to
receive benefits from, Progentix. Accordingly, the financial position and results of operations of
Progentix have been included in the Companys consolidated financial statements from the date of the Initial
Investment. The liabilities recognized as a result of consolidating Progentix do not represent
additional claims on the Companys general assets. The creditors of Progentix have claims only on
the assets of Progentix, which are not material, and the assets of Progentix are not available to
NuVasive.
Pursuant to authoritative guidance, the equity interests in Progentix not owned by the
Company, which includes shares of both common and preferred stock, are reported as noncontrolling
interests on the consolidated balance sheet of the Company. The preferred stock represents 18% of
the noncontrolling equity interests and provides for a cumulative 8% dividend, if and when declared
by Progentixs Board of Directors. As the rights and conversion features of the preferred stock are
substantially the same as those of the common stock, the preferred stock is classified as
noncontrolling interest and shares in the allocation of the losses incurred by Progentix. Losses
incurred by Progentix are charged to the Company and to the noncontrolling interest holders based
on their ownership percentage. The Remaining Shares and the Option Agreement that was entered into
between NuVasive, Progentix and the Progentix Shareholders are not considered to be freestanding
financial instruments as defined by authoritative guidance. Therefore the Remaining Shares and the
Option Agreement are accounted for as a combined unit on the consolidated financial statements as a
redeemable noncontrolling interest that was initially recorded at fair value and classified as
mezzanine equity.
Total assets and liabilities of Progentix as of June 30, 2011 included in the accompanying
condensed consolidated balance sheet are as follows (in thousands):
|
|
|
|
|
Total current assets |
|
$ |
615 |
|
Identifiable intangible assets, net |
|
|
15,569 |
|
Goodwill |
|
|
12,654 |
|
Other long-term assets |
|
|
426 |
|
Accounts payable & accrued expenses |
|
|
234 |
|
Other long-term liabilities |
|
|
478 |
|
Deferred tax liabilities, net |
|
|
3,685 |
|
Noncontrolling interests |
|
|
11,138 |
|
8
The following is a reconciliation of equity (net assets) attributable to the noncontrolling
interests (in thousands):
|
|
|
|
|
Noncontrolling interests at December 31, 2010 |
|
$ |
11,877 |
|
Net loss attributable to the noncontrolling interests |
|
|
(739 |
) |
|
|
|
|
Noncontrolling interests at June 30, 2011 |
|
$ |
11,138 |
|
|
|
|
|
4. Balance Sheet Reserves
The balances of the reserves for accounts receivable and inventory are as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
2011 |
|
2010 |
Reserves for accounts receivable and sales returns |
|
$ |
3,102 |
|
|
$ |
2,573 |
|
Reserves for excess and obsolete inventory |
|
|
9,023 |
|
|
|
6,682 |
|
The Companys inventory consists primarily of purchased finished goods, which includes
specialized implants and disposables, and is stated at the lower of cost or market determined by a
weighted average cost method. The Company reviews the components of its inventory on a periodic
basis for excess, obsolete or impaired inventory, and records a reserve for the identified items.
5. Marketable Securities and Fair Value Measurements
Marketable securities consist of certificates of deposit, corporate debt securities, U.S.
government treasury securities and securities of government-sponsored entities. The Company
classifies all securities as available-for-sale, as the sale of such securities may be required
prior to maturity to implement management strategies. These securities are carried at fair value,
with the unrealized gains and losses reported as a component of other comprehensive income in
stockholders equity until realized. A decline in the market value of any marketable security below
cost that is determined to be other than temporary will result in a revaluation of its carrying
amount to fair value. The impairment is charged to earnings and a new cost basis for the security
is established. No such impairment charges were recorded for any period presented.
Realized gains and losses from the sale of marketable securities, if any, are determined on a
specific identification basis. Realized gains and losses and declines in value judged to be
other-than-temporary, if any, on available-for-sale securities are included in other income or
expense on the consolidated statements of income. Realized gains and losses during the periods
presented were immaterial. Premiums and discounts are amortized or accreted over the life of the
related security as an adjustment to yield using the straight-line method and are included in
interest income on the consolidated statements of income. Interest and dividends on securities
classified as available-for-sale are included in interest income on the consolidated statements of
income.
9
The composition of marketable securities is as follows (in thousands, except years):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contractual |
|
|
|
|
|
Gross |
|
|
Gross |
|
|
|
|
|
|
Maturity |
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
|
|
|
|
(in Years) |
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Fair Value |
|
June 30, 2011: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Classified as current assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Certificates of deposit |
|
Less than 1 |
|
$ |
834 |
|
|
$ |
1 |
|
|
$ |
|
|
|
$ |
835 |
|
Corporate notes |
|
Less than 1 |
|
|
11,183 |
|
|
|
12 |
|
|
|
|
|
|
|
11,195 |
|
U.S. government treasury securities |
|
Less than 1 |
|
|
2,514 |
|
|
|
1 |
|
|
|
|
|
|
|
2,515 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term marketable securities |
|
|
|
|
14,531 |
|
|
|
14 |
|
|
|
|
|
|
|
14,545 |
|
|
Classified as non-current assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Certificates of deposit |
|
1 to 2 |
|
|
97 |
|
|
|
|
|
|
|
|
|
|
|
97 |
|
Securities of government-sponsored entities |
|
1 to 2 |
|
|
4,500 |
|
|
|
6 |
|
|
|
|
|
|
|
4,506 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term marketable securities |
|
|
|
|
4,597 |
|
|
|
6 |
|
|
|
|
|
|
|
4,603 |
|
|
Classified as restricted investments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government treasury securities |
|
Less than 1 to 2 |
|
|
12,045 |
|
|
|
7 |
|
|
|
(1 |
) |
|
|
12,051 |
|
Securities of government-sponsored entities |
|
Less than 1 to 2 |
|
|
50,740 |
|
|
|
27 |
|
|
|
(27 |
) |
|
|
50,740 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted investments |
|
|
|
|
62,785 |
|
|
|
34 |
|
|
|
(28 |
) |
|
|
62,791 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total marketable securities at June 30, 2011 |
|
|
|
$ |
81,913 |
|
|
$ |
54 |
|
|
$ |
(28 |
) |
|
$ |
81,939 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contractual |
|
|
|
|
|
Gross |
|
|
Gross |
|
|
|
|
|
|
Maturity |
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
|
|
|
|
(in Years) |
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Fair Value |
|
December 31, 2010: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Classified as current assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Certificates of deposit |
|
Less than 1 |
|
$ |
938 |
|
|
$ |
1 |
|
|
$ |
(1 |
) |
|
$ |
938 |
|
Corporate notes |
|
Less than 1 |
|
|
12,076 |
|
|
|
3 |
|
|
|
|
|
|
|
12,079 |
|
U.S. government treasury securities |
|
Less than 1 |
|
|
16,550 |
|
|
|
12 |
|
|
|
(1 |
) |
|
|
16,561 |
|
Securities of government-sponsored entities |
|
Less than 1 |
|
|
56,870 |
|
|
|
24 |
|
|
|
(14 |
) |
|
|
56,880 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term marketable securities |
|
|
|
|
86,434 |
|
|
|
40 |
|
|
|
(16 |
) |
|
|
86,458 |
|
|
Classified as non-current assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Certificates of deposit |
|
1 to 2 |
|
|
456 |
|
|
|
|
|
|
|
|
|
|
|
456 |
|
Corporate notes |
|
1 to 2 |
|
|
3,123 |
|
|
|
|
|
|
|
(9 |
) |
|
|
3,114 |
|
U.S. government treasury securities |
|
1 to 2 |
|
|
4,023 |
|
|
|
|
|
|
|
|
|
|
|
4,023 |
|
Securities of government-sponsored entities |
|
1 to 2 |
|
|
43,056 |
|
|
|
6 |
|
|
|
(20 |
) |
|
|
43,042 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term marketable securities |
|
|
|
|
50,658 |
|
|
|
6 |
|
|
|
(29 |
) |
|
|
50,635 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total marketable securities at December 31, 2010 |
|
|
|
$ |
137,092 |
|
|
$ |
46 |
|
|
$ |
(45 |
) |
|
$ |
137,093 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of June 30, 2011, the Company had no significant investment positions that were in an
unrealized loss position. The Company reviews its investments to identify and evaluate investments
that have an indication of possible other-than-temporary impairment. Factors considered in
determining whether a loss is other-than-temporary include the length of time and extent to which
fair value has been less than the cost basis, the financial condition and near-term prospects of
the investee, and the Companys intent and ability to hold the investment for a period of time
sufficient to allow for any anticipated recovery in market value. The Company maintains an
investment portfolio of various holdings, types and maturities. The Company does not have derivative
financial investments. The Company places its cash investments in instruments that meet high credit
quality standards, as specified in its investment policy guidelines. These guidelines also limit
the amount of credit exposure to any one issue, issuer or type of instrument.
The Company measures certain assets and liabilities in accordance with authoritative guidance
which requires fair value measurements be classified and disclosed in one of the following three
categories:
Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date
for assets or liabilities.
Level 2: Observable prices that are based on inputs not quoted on active markets, but corroborated
by market data.
10
Level 3: Unobservable inputs are used when little or no market data is available.
Assets and liabilities are classified based on the lowest level of input that is significant
to the fair value measurements. The Company reviews the fair value hierarchy classification on a
quarterly basis. Changes in the ability to observe valuation inputs may result in a
reclassification of levels for certain assets or liabilities within the fair value hierarchy. The Company did
not have any transfers of assets and liabilities between Level 1 and Level 2 and no transfers to or
from Level 3 of the fair value measurement hierarchy during the six months ended June 30, 2011.
The fair values of the Companys assets and liabilities at June 30, 2011, which are measured
at fair value on a recurring basis, were determined using the following inputs (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quoted Price in |
|
|
Significant Other |
|
|
Significant |
|
|
|
|
|
|
|
Active Market |
|
|
Observable Inputs |
|
|
Unobservable |
|
|
|
Total |
|
|
(Level 1) |
|
|
(Level 2) |
|
|
Inputs (Level 3) |
|
Marketable Securities and Restricted Investments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Certificates of deposit |
|
$ |
932 |
|
|
$ |
932 |
|
|
$ |
|
|
|
$ |
|
|
Corporate notes |
|
|
11,195 |
|
|
|
11,195 |
|
|
|
|
|
|
|
|
|
U.S. government treasury securities |
|
|
14,566 |
|
|
|
14,566 |
|
|
|
|
|
|
|
|
|
Securities of government-sponsored entities |
|
|
55,246 |
|
|
|
55,246 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total marketable securities and restricted investments |
|
$ |
81,939 |
|
|
$ |
81,939 |
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivative Asset: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible note hedge derivative |
|
$ |
80,098 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
80,098 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent Consideration: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquisition-related liabilities |
|
$ |
(33,955 |
) |
|
$ |
|
|
|
$ |
|
|
|
$ |
(33,955 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivative Liability: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Embedded conversion derivative |
|
$ |
(88,900 |
) |
|
$ |
|
|
|
$ |
|
|
|
$ |
(88,900 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
The fair and carrying value of the Companys Senior Convertible Notes is discussed in Note 7.
Contingent Consideration Liability
In connection with the acquisition of Cervitech®, Inc. (Cervitech) in May 2009, the Company is
required to pay an additional amount not to exceed $33.0 million in the event that the PCM®
cervical total disc replacement device receives U.S. Food and Drug Administration approval. The
fair value of the contingent consideration is determined using a probability-weighted discounted
cash flow model, the significant inputs which are not observable in the market. The key assumptions
in applying this approach are the interest rate, the timing of expected approval and the
probability assigned to the milestone being achieved. Based on the expected timing of the milestone
being achieved, the estimated fair value of the contingent consideration increased to $32.5 million
at June 30, 2011. Changes in fair value are recorded in the statement of income as sales, marketing
and administrative expenses.
In connection with an immaterial acquisition in 2010, the Company is required to pay an
additional amount not to exceed $3.0 million in the event three specified milestones are met. The
fair value of the contingent consideration is determined using a probability-weighted discounted
cash flow model, the significant inputs of which are not observable in the market. The key
assumptions in applying this approach are the interest rate and the probabilities assigned to the
milestones being achieved. Based on the probabilities assigned to the milestones being achieved,
the estimated fair value of the contingent consideration totaled $1.5 million at June 30, 2011.
Changes in fair value are recorded in the statement of income as sales, marketing and
administrative expenses.
Derivative Financial Instruments
The Convertible note hedge derivative (the 2017 Hedge) and the Embedded conversion derivative (the 2017
Notes Embedded Conversion Derivative) are classified as Level 3 because these assets and
liabilities are not actively traded and are valued using significant
11
unobservable inputs. Significant inputs to these
models are the Companys stock price, risk free interest rate,
credit rating, bond yield, and
expected volatility of the Companys stock price.
The
following tables set forth the changes in the estimated fair value
for the Companys assets and
liabilities measured using significant unobservable inputs (Level 3) (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair value measurement at beginning of period |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Derivative asset purchased |
|
|
80,098 |
|
|
|
|
|
|
|
80,098 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair value measurement at end of period |
|
$ |
80,098 |
|
|
$ |
|
|
|
$ |
80,098 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair value measurement at beginning of period |
|
$ |
33,494 |
|
|
$ |
30,694 |
|
|
$ |
33,041 |
|
|
$ |
30,694 |
|
Derivative liability recorded in connection with 2017 Notes |
|
|
88,900 |
|
|
|
|
|
|
|
88,900 |
|
|
|
|
|
Change in fair value measurement included in operating expenses |
|
|
461 |
|
|
|
182 |
|
|
|
914 |
|
|
|
182 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair value measurement at end of period |
|
$ |
122,855 |
|
|
$ |
30,876 |
|
|
$ |
122,855 |
|
|
$ |
30,876 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6. Goodwill and Intangible Assets
Goodwill and intangible assets as of June 30, 2011 consisted of the following (in thousands,
except years):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
|
|
|
|
Amortization |
|
Gross |
|
|
|
|
|
|
|
|
|
Period |
|
Carrying |
|
|
Accumulated |
|
|
Intangible |
|
|
|
(in years) |
|
Amount |
|
|
Amortization |
|
|
Assets, net |
|
Intangible Assets Subject to Amortization: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchased technology: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Developed technology |
|
14 |
|
$ |
37,535 |
|
|
$ |
(9,211 |
) |
|
$ |
28,324 |
|
Manufacturing know-how and trade secrets |
|
12 |
|
|
21,161 |
|
|
|
(5,096 |
) |
|
|
16,065 |
|
Trade name and trademarks |
|
14 |
|
|
6,100 |
|
|
|
(1,179 |
) |
|
|
4,921 |
|
Customer relationships |
|
13 |
|
|
10,035 |
|
|
|
(3,350 |
) |
|
|
6,685 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14 |
|
$ |
74,831 |
|
|
$ |
(18,836 |
) |
|
$ |
55,995 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible Assets Not Subject to Amortization: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In-process research and development |
|
|
|
|
|
|
|
|
|
|
|
|
45,440 |
|
Goodwill |
|
|
|
|
|
|
|
|
|
|
|
|
103,070 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total intangible assets, net |
|
|
|
|
|
|
|
|
|
|
|
$ |
204,505 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Goodwill and intangible assets as of December 31, 2010 consisted of the following (in
thousands, except years):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
|
|
|
|
Amortization |
|
Gross |
|
|
|
|
|
|
|
|
|
Period |
|
Carrying |
|
|
Accumulated |
|
|
Intangible |
|
|
|
(in years) |
|
Amount |
|
|
Amortization |
|
|
Assets, net |
|
Intangible Assets Subject to Amortization: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchased technology: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Developed technology |
|
14 |
|
$ |
39,975 |
|
|
$ |
(7,946 |
) |
|
$ |
32,029 |
|
Manufacturing know-how and trade secrets |
|
12 |
|
|
21,104 |
|
|
|
(4,207 |
) |
|
|
16,897 |
|
Trade name and trademarks |
|
14 |
|
|
6,100 |
|
|
|
(956 |
) |
|
|
5,144 |
|
Customer relationships |
|
13 |
|
|
10,035 |
|
|
|
(2,984 |
) |
|
|
7,051 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14 |
|
$ |
77,214 |
|
|
$ |
(16,093 |
) |
|
$ |
61,121 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible Assets Not Subject to Amortization: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In-process research and development |
|
|
|
|
|
|
|
|
|
|
|
|
46,000 |
|
Goodwill |
|
|
|
|
|
|
|
|
|
|
|
|
103,070 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total intangible assets, net |
|
|
|
|
|
|
|
|
|
|
|
$ |
210,191 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total expense related to the amortization of intangible assets was $1.4 million for both the
three months ended June 30, 2011 and 2010, and $2.7 million for both the six months ended June 30,
2011 and 2010. In-process research and development will be amortized beginning on the regulatory
approval date of the respective acquired products and will be amortized over the estimated useful
life determined at that time.
12
Total future amortization expense related to intangible assets subject to amortization at June
30, 2011 is set forth in the table below (in thousands):
|
|
|
|
|
Remaining 2011 |
|
$ |
2,912 |
|
2012 |
|
|
5,821 |
|
2013 |
|
|
5,803 |
|
2014 |
|
|
5,766 |
|
2015 |
|
|
5,445 |
|
2016 |
|
|
5,245 |
|
Thereafter through 2027 |
|
|
25,003 |
|
|
|
|
|
Total future amortization expense |
|
$ |
55,995 |
|
|
|
|
|
7. Senior Convertible Notes
The carrying values of the Companys Senior Convertible Notes as of June 30, 2011 are as
follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2011 |
|
|
2010 |
|
2.75% Senior Convertible Notes due 2017: |
|
|
|
|
|
|
|
|
Principal amount |
|
$ |
402,500 |
|
|
$ |
|
|
Unamortized debt discount |
|
|
(88,804 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
313,696 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2.25% Senior Convertible Notes due 2013 |
|
|
230,000 |
|
|
|
230,000 |
|
|
|
|
|
|
|
|
Total Senior Convertible Notes |
|
$ |
543,696 |
|
|
$ |
230,000 |
|
|
|
|
|
|
|
|
2.75% Senior Convertible Notes due 2017
In June 2011, the Company issued $402.5 million principal amount of 2.75% Senior Convertible
Notes due 2017 (the 2017 Notes), which includes the issuance of $52.5 million principal amount for
the exercise of the initial purchasers option to purchase additional notes. The net proceeds from
the offering, after deducting initial purchasers discounts and costs directly related to the
offering, were approximately $359.0 million. The 2017 Notes have a stated interest rate of 2.75%,
mature on July 1, 2017 and may be settled only in cash, unless stockholder approval is obtained to
increase the number of the Companys authorized shares of common stock. Interest on the 2017 Notes
began accruing in June 2011 and is payable semi-annually each January 1st and July
1st, beginning January 1, 2012. The fair value, based on quoted market prices, of the
outstanding 2017 Notes at June 30, 2011 is approximately $402.6 million.
Assuming the Company has received stockholder approval to increase the number of the Companys
authorized shares of common stock, the Company will settle conversions of the 2017 Notes by paying
or delivering, as the case may be, cash, shares of common stock, or a combination of cash and
shares of common stock, solely at the Companys election. The initial conversion rate of the 2017
Notes is 23.7344 shares per $1,000 principal amount, subject to adjustment (which represents an
initial conversion price of approximately $42.13 per share).
Prior to January 1, 2017, holders may convert their notes only under the following conditions:
a) During any calendar quarter beginning October 1, 2011, if the reported sale price of the
Companys common stock for at least 20 days of 30 consecutive trading days ending on the last
trading day of the immediately preceding calendar quarter is greater than 130% of the conversion
price on each applicable trading day; b) During the five business day period in which the trading
price of the 2017 Notes falls below 98% of the product of (i) the last reported sale price of the
Companys common stock and (ii) the conversion rate on that date; and c) Upon the occurrence of
specified corporate events, as defined in the 2017 Notes. From January 1, 2017 and until the close
of business on the second scheduled trading day immediately preceding the July 1, 2017, holders may
convert their 2017 Notes at any time, regardless of the foregoing circumstances. The Company may
not redeem the 2017 Notes prior to maturity.
13
Other than restrictions relating to certain fundamental changes and consolidations, mergers or
asset sales and customary anti-dilution adjustments, the 2017 Notes do not contain any financial
covenants and do not restrict the Company from paying dividends or issuing or repurchasing any of
its other securities.
In
accordance with authoritative guidance, the cash conversion feature of the 2017 Notes (the 2017
Notes Embedded Conversion Derivative) requires bifurcation from the 2017 Notes and is accounted for
as a derivative liability, which is included in long-term liabilities
in the Companys condensed consolidated balance sheet. The fair value of the 2017 Notes Embedded Conversion Derivative at the
time of issuance of the 2017 Notes was $88.9 million, and was recorded as the original debt
discount for purposes of accounting for the debt component of the 2017 Notes. This discount will be
recognized as interest expense using the effective interest method over the term of the 2017 Notes.
The estimated fair value of the 2017 Notes Embedded Conversion Derivative was $88.9 million as of
June 30, 2011.
In connection with the offering of the 2017 Notes, the Company entered into convertible note
hedge transactions (the 2017 Hedge) with the initial purchasers and/or their affiliates (the
Counterparties) entitling the Company, assuming stockholder approval is obtained to increase the
number of the Companys authorized shares of common stock as discussed previously, to purchase up
to 9,553,096 shares of the Companys common stock at an initial stock price of $42.13 per share,
each of which is subject to adjustment. Until stockholder approval of an increase in the number of
the Companys authorized common shares is obtained, the 2017 Hedge may be settled only in cash.
Assuming stockholder approval is obtained, the 2017 Hedge is expected to reduce the potential
equity dilution upon conversion of the 2017 Notes if the daily volume-weighted average price per
share of the Companys common stock exceeds the strike price of the 2017 Hedge. The 2017 Hedge is
accounted for as a derivative asset, and is included in long-term
assets in the Companys condensed consolidated balance sheet. The cost of the 2017 Hedge was $80.1 million, which also represents its
estimated fair value as of June 30, 2011. The 2017 Hedge expires on July 1, 2017.
The 2017 Notes Embedded Conversion Derivative and the 2017 Hedge are adjusted to fair value
each reporting period and gains and losses are recorded in the
Companys condensed consolidated
statements of income. As the fair values of the 2017 Notes Embedded
Conversion Derivative and the
2017 Hedge on June 28, 2011 approximate their respective fair
values as of June 30, 2011, no such
gains or losses were recorded during the three and six months ended June 30, 2011.
In addition, the Company sold warrants to the Counterparties to acquire up to 477,654 shares
of the Companys Series A Participating Preferred Stock (the 2017 Warrants), at an initial strike
price of $988.51 per share, subject to adjustment. If the Company
receives the necessary stockholder approvals to increase the number
of common shares available for issuance, each share of Series A Participating Preferred
Stock is initially convertible into 20 shares of the Companys common stock. The 2017 Warrants
expire on various dates from September 2017 through January 2018 and may be settled in cash or
net shares. The Company received $47.9 million in cash proceeds from the sale of the 2017 Warrants,
which has been recorded as an increase in additional paid-in-capital. The 2017 Warrants could have
a dilutive effect on the Companys earnings per share to the extent that the price of the Companys
common stock during a given measurement period (the quarter or year-to-date period) exceeds the
strike price of the 2017 Warrants.
2.25% Senior Convertible Notes due 2013
In March 2008, the Company issued $230.0 million principal amount of 2.25% unsecured Senior
Convertible Notes (the 2013 Notes), which includes the subsequent exercise of the initial
purchasers option to purchase an additional $30.0 million aggregate principal amount of the 2013
Notes. The net proceeds from the offering, after deducting the
initial purchasers discounts and
costs directly related to the offering, were approximately $208.4 million. The Company pays 2.25%
interest per annum on the principal amount of the 2013 Notes, payable semi-annually in arrears in
cash on March 15 and September 15 of each year. Any of the 2013 Notes not converted prior to March
15, 2013, the Maturity Date, will be paid in cash. The fair value, based on quoted market prices,
of the outstanding 2013 Notes at June 30, 2011 is approximately $240.1 million.
The 2013 Notes are convertible into shares of the Companys common stock, based on an initial
conversion rate, subject to adjustment, of 22.3515 shares per $1,000 principal amount of the 2013
Notes (which represents an initial conversion price of approximately $44.74 per share). Holders may
convert their 2013 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 2013 Notes, holders of the 2013 Notes have the right to require
that the Company repurchase the 2013 Notes, or a portion thereof, at the principal amount plus
accrued and unpaid interest.
14
In connection with the offering of the 2013 Notes, the Company entered into convertible note
hedge transactions (the 2013 Hedge) with the initial purchasers and/or their affiliates (the 2013
Counterparties) entitling the Company to purchase up to 5.1 million shares of the Companys common
stock at an initial stock price of $44.74 per share, each of which is subject to adjustment. In
addition, the Company sold to the 2013 Counterparties warrants to acquire up to 5.1 million shares
of the Companys common stock (the 2013 Warrants), at an initial strike price of $49.13 per share,
subject to adjustment. The cost of the 2013 Hedge that was not covered by the proceeds from the
sale of the 2013 Warrants was approximately $14.0 million and was recorded as a reduction of
additional paid-in capital as of December 31, 2008. The impact of the 2013 Hedge is to raise the
effective conversion price of the 2013 Notes to approximately $49.13 per share (or approximately
20.3542 shares per $1,000 principal amount of the 2013 Notes). The 2013 Hedge is expected to reduce
the potential equity dilution upon conversion of the 2013 Notes if the daily volume-weighted
average price per share of the Companys common stock exceeds the strike price of the 2013 Hedge.
The 2013 Warrants could have a dilutive effect on the Companys earnings per share to the extent
that the price of the Companys common stock during a given measurement period (the quarter or year
to date period) exceeds the strike price of the 2013 Warrants.
8. Series A Preferred Securities
On June 28, 2011, in connection with the issuance of the 2017 Warrants, the Company amended
its Restated Certificate of Incorporation to designate 477,654 shares of the Companys authorized
preferred stock, par value $0.001 per share, as Series A Participating Preferred Stock (the Series
A Preferred Stock). The Series A Preferred Stock will automatically convert into shares of the
Companys common stock if the Company receives the necessary stockholder approvals to increase the
number of common shares available for issuance. If the Company has not received such stockholder
approvals before the 2017 Warrants are converted into Series A Preferred Stock, the shares of
Series A Preferred Stock will accumulate cash dividends at specified dividend rates, beginning on
June 1, 2012, for as long as such shares remain outstanding.
The holders of Series A Preferred Stock (collectively, the Preferred Holders) are entitled
to receive dividends when and if declared by the Board of Directors. The preferred dividends are
payable in preference and in priority to any dividends on the Companys common stock.
Shares of Series A Preferred Stock are convertible into 20 shares of common stock, subject to
certain antidilution adjustments. Preferred Holders vote on an equivalent basis with common
stockholders on an as-converted basis.
The Preferred Holders are entitled to receive liquidation preferences at the rate of $648.20
per share. Liquidation payments to the Preferred Holders have priority and are made in preference
to any payments to the holders of common stock.
If the necessary stockholder approvals to increase the number of common shares available for
issuance are not obtained prior to June 1, 2012, and dividends have not been paid on the shares of
Series A Preferred Stock for an aggregate of six quarterly dividend periods or more, the Preferred
Holders are entitled to elect two members to the Companys Board of Directors.
9. Net Income Per Share
The Company computes basic net income per share using the weighted-average number of common
shares outstanding during the period. Diluted net income assumes the conversion, exercise or
issuance of all potential common stock equivalents, unless the effect of inclusion would be
anti-dilutive. For purposes of this calculation, common stock equivalents include the Companys
stock options, unvested restricted stock units, warrants and the shares to be issued upon the
conversion of the 2013 Notes. No shares related to the assumed conversion of the 2013 Notes were
included in the diluted net income calculation for the three and six months ended June 30, 2011 and
2010 because the inclusion of such shares would have had an anti-dilutive effect. The shares to be
issued upon exercise of all outstanding warrants were excluded from the diluted net income
calculation for the three and six months ended June 30, 2011 and 2010 because the inclusion of such
shares would have had an anti-dilutive effect.
15
The following table sets forth the computation of basic and diluted earnings per share (in
thousands, except per share data):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2011 |
|
2010 |
|
2011 |
|
2010 |
Numerator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income attributable to NuVasive, Inc. |
|
$ |
5,380 |
|
|
$ |
6,723 |
|
|
$ |
7,739 |
|
|
$ |
7,811 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator for basic and diluted net income per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding for basic |
|
|
39,786 |
|
|
|
39,242 |
|
|
|
39,701 |
|
|
|
39,071 |
|
Dilutive potential common stock outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options |
|
|
726 |
|
|
|
1,272 |
|
|
|
682 |
|
|
|
1,165 |
|
Restricted stock units |
|
|
356 |
|
|
|
180 |
|
|
|
308 |
|
|
|
147 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding for diluted |
|
|
40,868 |
|
|
|
40,694 |
|
|
|
40,691 |
|
|
|
40,383 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income per share attributable to NuVasive, Inc. |
|
$ |
0.14 |
|
|
$ |
0.17 |
|
|
$ |
0.19 |
|
|
$ |
0.20 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income per share attributable to NuVasive, Inc. |
|
$ |
0.13 |
|
|
$ |
0.17 |
|
|
$ |
0.19 |
|
|
$ |
0.19 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following outstanding common stock equivalents were not included in the calculation of net
income per diluted share because their effects were anti-dilutive (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2011 |
|
2010 |
|
2011 |
|
2010 |
Weighted stock options and RSUs |
|
|
4,874 |
|
|
|
1,483 |
|
|
|
5,035 |
|
|
|
2,885 |
|
Warrants |
|
|
5,141 |
|
|
|
5,141 |
|
|
|
5,141 |
|
|
|
5,141 |
|
2013 Notes |
|
|
5,141 |
|
|
|
5,141 |
|
|
|
5,141 |
|
|
|
5,141 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
15,156 |
|
|
|
11,765 |
|
|
|
15,317 |
|
|
|
13,167 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10. Comprehensive Income
The components of comprehensive income are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2011 |
|
2010 |
|
2011 |
|
2010 |
Consolidated net income |
|
$ |
5,022 |
|
|
$ |
6,190 |
|
|
$ |
7,000 |
|
|
$ |
6,896 |
|
Other comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain on investments |
|
|
37 |
|
|
|
108 |
|
|
|
26 |
|
|
|
95 |
|
Translation adjustments |
|
|
346 |
|
|
|
(665 |
) |
|
|
1,056 |
|
|
|
(1,071 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total consolidated comprehensive income |
|
|
5,405 |
|
|
|
5,633 |
|
|
|
8,082 |
|
|
|
5,920 |
|
Plus: Net loss attributable to noncontrolling interests |
|
|
(358 |
) |
|
|
(533 |
) |
|
|
(739 |
) |
|
|
(915 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income attributable to NuVasive, Inc. |
|
$ |
5,763 |
|
|
$ |
6,166 |
|
|
$ |
8,821 |
|
|
$ |
6,835 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11. Stock-Based Compensation
The Company estimates the fair value of stock options and shares issued to employees under the
Employee Stock Purchase Plan (ESPP Plan) using a Black-Scholes option-pricing model on the date of
grant. The fair value of restricted stock units (RSUs) is based on the stock price on the date of
grant. The fair value of equity instruments that are expected to vest are recognized and amortized
on an accelerated basis over the requisite service period.
16
The weighted-average assumptions used to estimate the fair value of stock options granted and
stock purchase rights under the ESPP Plan are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2011 |
|
2010 |
|
2011 |
|
2010 |
Stock Options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Volatility |
|
|
48 |
% |
|
|
48 |
% |
|
|
49 |
% |
|
|
47 |
% |
Expected term (years) |
|
|
5.4 |
|
|
|
4.5 |
|
|
|
5.4 |
|
|
|
4.5 |
|
Risk free interest rate |
|
|
2.0 |
% |
|
|
2.0 |
% |
|
|
2.1 |
% |
|
|
2.4 |
% |
Expected dividend yield |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ESPP |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Volatility |
|
|
57 |
% |
|
|
54 |
% |
|
|
58 |
% |
|
|
52 |
% |
Expected term (years) |
|
|
1.2 |
|
|
|
1.3 |
|
|
|
1.1 |
|
|
|
1.3 |
|
Risk free interest rate |
|
|
0.3 |
% |
|
|
0.9 |
% |
|
|
0.2 |
% |
|
|
0.9 |
% |
Expected dividend yield |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
The compensation costs included in the consolidated statement of income for all stock-based
compensation arrangements are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2011 |
|
2010 |
|
2011 |
|
2010 |
Sales, marketing and administrative expense |
|
$ |
7,124 |
|
|
$ |
6,672 |
|
|
$ |
14,459 |
|
|
$ |
12,352 |
|
Research and development expense |
|
|
601 |
|
|
|
877 |
|
|
|
1,212 |
|
|
|
1,631 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stock-based compensation expense |
|
$ |
7,725 |
|
|
$ |
7,549 |
|
|
$ |
15,671 |
|
|
$ |
13,983 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Company issued 71,000 and 96,000 shares of common stock upon exercise of stock options
during the three and six months ended June 30, 2011, respectively, and issued 524,000 shares of
common stock upon exercise of stock options during the year ended December 31, 2010. The Company
issued 20,000 and 120,000 shares of common stock upon the vesting of RSUs during the three and six
months ended June 30, 2011, respectively, and issued 73,000 shares of common stock upon the vesting
of RSUs during the year ended December 31, 2010.
12. Income Taxes
The Company recorded income tax expense of $4.8 million and $0.6 million for the three months
ended June 30, 2011 and 2010, respectively, and $6.3 million and $1.4 million for the six months
ended June 30, 2011 and 2010, respectively. The effective income tax rate for the six months ended
June 30, 2011 was 47%, which is based on an estimate of the Companys annual effective income tax
rate. The Company updates its annual effective income tax rate each quarter and if the estimated
effective income tax rate changes, a cumulative adjustment is made. The annual effective income tax
rate for 2011 is expected to be higher than the U.S. federal statutory rate of 35% primarily due to
state income taxes, net of federal benefit, estimates for certain non-deductible expenses, and
foreign losses expected to be incurred for which no benefit can be recorded.
There was no material change to the Companys unrecognized tax benefits and interest accrued
related to unrecognized tax benefits during the six months ended June 30, 2011.
13. Business Segment and Product Information
The Companys business operates in one segment based upon the Companys organizational
structure, the way in which the operations are managed and evaluated and the lack of availability
of separate financial results. Substantially all of the Companys assets and sales are in the
United States.
17
The Companys spine surgery product line offerings, which include thoracolumbar product
offerings, cervical offerings, and a set of motion preservation products still under development,
are primarily used to enable access to the spine and to perform restorative and fusion procedures
in a minimally disruptive fashion. The Companys biologic product line offerings include allograft
(donated human tissue), Osteocel®
Plustm, an allograft cellular matrix containing viable mesenchymal stem
cells, or MSCs, to aid in spinal fusion, and FormaGraft
®, a collagen synthetic product used to aid
the fusion process. Revenue by product line offerings was as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2011 |
|
2010 |
|
2011 |
|
2010 |
Spine Surgery Products |
|
$ |
108,753 |
|
|
$ |
97,863 |
|
|
$ |
210,661 |
|
|
$ |
187,014 |
|
Biologics |
|
|
24,213 |
|
|
|
21,721 |
|
|
|
46,771 |
|
|
|
41,657 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Revenue |
|
$ |
132,966 |
|
|
$ |
119,584 |
|
|
$ |
257,432 |
|
|
$ |
228,671 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14. Legal Proceedings
Medtronic Sofamor Danek USA, Inc. Litigation
In August 2008, Medtronic Sofamor Danek USA, Inc. and its related
entities (Medtronic) filed suit against NuVasive in the United States District Court for the
Southern District of California (Medtronic Litigation), alleging that certain of NuVasives
products infringe, or contribute to the infringement of, twelve U.S. patents assigned or licensed
to Medtronic. Three of the patents were later withdrawn by Medtronic, leaving nine patents.
NuVasive brought counterclaims against Medtronic alleging infringement of certain of NuVasives
patents. The case has been administratively broken into serial phases. The initial phase of the
case includes three Medtronic patents and one NuVasive patent. Trial on the initial phase of the
case is scheduled to begin August 30, 2011. A full schedule for the second phase of the lawsuit has
not yet been set by the Court. NuVasive believes its own claims have merit and that Medtronics
claims lack merit. At June 30, 2011, the probable outcome of this litigation cannot be determined,
nor can the Company estimate a range of potential loss. Accordingly, in accordance with the
authoritative guidance on the evaluation of contingencies, the Company has not recorded an accrual
related to this litigation.
Trademark Infringement Litigation
In September 2009, Neurovision Medical Products, Inc. (NMP) filed suit against NuVasive in the
U.S. District Court for the Central District of California (Case No. 2:09-cv-06988-R-JEM) alleging
trademark infringement and unfair competition. NMP sought cancellation of NuVasives NeuroVision
trademark registrations, injunctive relief and damages based on NMPs common law use of the
Neurovision mark. On November 23, 2009, the Company denied the allegations in NMPs complaint.
After trial of the matter, on October 25, 2010 an unfavorable jury verdict was delivered against
the Company relating to its use of the NeuroVision trade name. The verdict awarded damages to NMP
of $60.0 million. On January 3, 2011, the Court ordered a judgment be entered in the case in the
amount of $60.0 million, and granted a permanent injunction prohibiting the Companys use of the
NeuroVision name for marketing purposes. The Company sought emergency relief, and on February 3,
2011, the Ninth Circuit Court of Appeals stayed enforcement of the injunction. The Company intends
to timely appeal the judgment and permanent injunction. During pendency of the appeal, the Company
has been required to escrow funds to secure the amount of the judgment, plus interest, attorneys
fees and costs. On June 16, 2011, the Company entered into an escrow arrangement and transferred
$62.5 million of cash and investments into a restricted escrow account. These funds are included in
restricted cash and investments on the Companys June 30,
2011 condensed consolidated balance sheet. Any payment of
damages will be delayed while the appeals process runs its course, which could take up to two
years. The Company continues to believe that the verdict is not supported by the facts or by
applicable law. The Company, based on its own assessment as well as that of outside counsel,
believes that the trial court committed a number of prejudicial legal errors and that these errors
were significant, making the possibility of reversal of the judgment on appeal and/or a new trial
probable. Accordingly, at June 30, 2011, in accordance with the authoritative guidance on the
evaluation of contingencies, the Company has not recorded an accrual related to this litigation.
The Company may be required to record an expense related to this damage award in the future.
Contingencies
The Company is party to certain claims and legal actions arising in the normal course of
business. The Company does not expect any such claims and legal actions to have a material adverse
effect on its business, results of operations or financial condition.
18
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
Forward-Looking Statements May Prove Inaccurate
You should read the following discussion of our financial condition and results of operations
in conjunction with the unaudited condensed consolidated financial statements and the notes to
those statements included in this report. This discussion may contain forward-looking statements
that involve risks and uncertainties. Our actual results may differ materially from those
anticipated in these forward-looking statements as a result of certain factors, such as those set
forth under heading Risk Factors, and elsewhere in this report, and similar discussions in our
other Securities and Exchange Commission filings, including our Annual Report on Form 10-K for the
year ended December 31, 2010. We do not intend to update these forward looking statements to
reflect future events or circumstances.
Overview
We are a medical device company focused on developing minimally disruptive surgical products
and procedures for the spine. Our currently-marketed product portfolio is focused on applications
for spine fusion surgery, including biologics, a combined market estimated to exceed $7.7 billion
globally in 2011. Our principal product offering includes a minimally disruptive surgical platform
called Maximum Access Surgery, or MAS®, as well as a growing offering of biologics, cervical and
motion preservation products. Our spine surgery product line offerings, which include products for
the thoracolumbar spine, the cervical spine, and a set of motion preservation product offerings
still under development, are primarily used to enable access to the spine and to perform
restorative and fusion procedures in a minimally disruptive fashion. Our biologic product line
offerings include allograft (donated human tissue),
Osteocel®
Plustm, an allograft cellular matrix containing
viable mesenchymal stem cells, or MSCs, to aid in spinal fusion, and FormaGraft®, a collagen synthetic product used
to aid the fusion process. We focus significant research and
development efforts to expand our MAS product platform, advance the applications of our unique
technology to additional procedures and develop motion preserving products such as our total disc
replacement products. We dedicate significant resources toward training spine surgeons on our
unique technology and products. Currently, we are training over 500 surgeons annually, which
includes surgeons new to our MAS product platform as well as surgeons previously trained on our MAS
product platform who are attending advanced training programs.
Our MAS platform, with the unique advantages provided by our nerve monitoring systems, enables
an innovative lateral procedure known as eXtreme Lateral Interbody Fusion, or XLIF®, in which
surgeons access the spine for a fusion procedure from the side of the patients body, rather than
from the front or back. Our MaXcess® instruments provide access to the spine in a manner that
affords direct visualization and our nerve monitoring systems allow surgeons to avoid critical
nerves.
In the past certain insurance providers have adopted policies of not providing reimbursement
for the XLIF procedure. We have worked with our surgeon customers and certain surgical societies
who, in turn, have worked with these insurance providers to supply the information required to
categorize the XLIF procedure as a procedure entitled to reimbursement under their policies. Most
major insurance companies provide reimbursement for XLIF procedures, however certain smaller
regional carriers have policies against coverage of XLIF. NuVasive cannot offer definitive time
frames or final outcomes regarding reversal of the non-coverage policies, as the process is
dictated by the third-party insurance providers. To date, we have not experienced significant lack
of payment for our procedures based on these policies.
Factors arising from third parties such as prolonged interaction with regulatory agencies,
general pushback from private payers on any of our procedures, devices, or services, industry
specific taxes, and other external factors may have a material impact on our business. We have
begun to incur incremental expenditures to address these types of issues regionally and nationally
as deemed necessary. Such advocacy for improvements in the regulatory approval process, payer
coverage of new technologies, and policies that facilitate innovation to improve spine care are
likely to become an ongoing expense.
In recent years, we have significantly expanded our product offering relating to procedures in
the cervical spine as well as in the area of biologics. Our cervical product offering now provides
a full set of solutions for cervical fusion surgery, including both allograft and CoRoent®
implants, as well as cervical plating and posterior fixation products. In 2009, we acquired
Cervitech®, Inc. (Cervitech), a company focused on gaining regulatory approval of the PCM® cervical
disc system, a motion preserving total disc replacement device. This strategic acquisition allows
us the potential to accelerate our entry into the growing mechanical cervical disc replacement
market. In the first quarter of 2010, we filed a PMA application with the U.S. Food and Drug
Administration (FDA) for
19
approval of the PCM cervical disc system. Approval, if obtained, would further strengthen our
cervical product offering and should enable us to continue our trend of increasing our market
share.
In 2009 we purchased forty percent (40%) of the capital stock of Progentix Orthobiology, B.V.
(Progentix), a company organized under the laws of the Netherlands, from existing shareholders for
$10.0 million in cash (the Initial Investment). Progentix has as its objective the development and
exploitation of knowledge and technology in the field of synthetic bone graft materials to aid in
the healing and generation of human bone.
We have an active product development pipeline focused on expanding our current fusion product
platform as well as products designed to preserve spinal motion.
The majority of our revenues are derived from the sale of disposables and implants, and we
expect this trend to continue for the foreseeable future. We loan our proprietary software-driven
nerve monitoring systems and surgical instrument sets at no cost to surgeons and hospitals that
purchase disposables and implants for use in individual procedures. In addition, we place our
proprietary software-driven nerve monitoring systems, MaXcess and other MAS or cervical surgical
instrument sets with hospitals for an extended period at no up-front cost to them. Our implants and
disposables are currently sold and shipped from our primary distribution and warehousing operations
facility located in Memphis, Tennessee. We recognize revenue for disposables or implants used upon
receiving acknowledgement of a purchase order from the hospital indicating product use or
implantation. In addition, we sell an immaterial number of MAS instrument sets, MaXcess devices,
and our proprietary software-driven nerve monitoring systems. To date, we have derived less than 5%
of our total revenues from these sales.
Through June 30, 2011, substantially all of our operations are located in the United States
and substantially all of our sales have been generated in the United States. We sell our products
in the United States through a sales force comprised of exclusive independent sales agents and our
own directly-employed sales professionals; both selling only NuVasive spine surgery products. Our
sales force provides a delivery and consultative service to our surgeon and hospital customers and
is compensated based on sales and product placements in their territories. Sales force commissions
are reflected in our statement of income in the sales, marketing and administrative expense line.
We expect to continue to expand our distribution channel. Beginning late in 2007 and continuing
today, we are continuing our expansion of international sales efforts with the focus on European,
Asian and Latin American markets. Our international sales force is comprised of directly-employed
exclusive shareowners as well as exclusive distributors and independent sales agents.
In
June 2011, we issued $402.5 million principal amount of
2.75% Senior Convertible Notes due
2017 (the 2017 Notes), which includes the issuance of $52.5 million principal amount upon the
exercise of the initial purchasers option to purchase additional notes. The net proceeds from the
offering, after deducting initial purchasers discounts and costs directly related to the offering,
were approximately $359.0 million. We pay 2.75% interest per annum on the principal amount of the
2017 Notes. The 2017 Notes mature on July 1, 2017 and may be settled only in cash, unless
stockholder approval is obtained to increase the number of our authorized shares of common stock to
allow for conversion of the notes and exercise of warrants issued in connection with the debt
offering. Interest on the 2017 Notes began accruing in June 2010 and is payable semi-annually each
January 1st and July 1st, beginning January 1, 2012. The completion of this
financing transaction affords us greater flexibility and liquidity.
20
Results of Operations
Revenue
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
(dollars in thousands) |
|
2011 |
|
2010 |
|
$ Change |
|
% Change |
Three months ended: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Spine Surgery Products |
|
$ |
108,753 |
|
|
$ |
97,863 |
|
|
|
|
|
|
|
|
|
Biologics |
|
|
24,213 |
|
|
|
21,721 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Revenue |
|
$ |
132,966 |
|
|
$ |
119,584 |
|
|
$ |
13,382 |
|
|
|
11 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six months ended: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Spine Surgery Products |
|
$ |
210,661 |
|
|
$ |
187,014 |
|
|
|
|
|
|
|
|
|
Biologics |
|
|
46,771 |
|
|
|
41,657 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Revenue |
|
$ |
257,432 |
|
|
$ |
228,671 |
|
|
$ |
28,761 |
|
|
|
13 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Our spine surgery product line offerings, which include products for the thoracolumbar spine,
the cervical spine, and a set of motion preservation product offerings still under development, are
primarily used to enable access to the spine and to perform restorative and fusion procedures in a
minimally disruptive fashion. Our biologics product line offerings include allograft (donated human
tissue), Osteocel
Plus, an allograft cellular matrix containing viable mesenchymal stem cells, or MSCs, to aid in
spinal fusion, and FormaGraft, a collagen synthetic product used to aid the
fusion process.
The continued adoption of minimally invasive procedures for spine has led to the continued
expansion of our innovative lateral procedure known as eXtreme Lateral Interbody Fusion, or XLIF,
in which surgeons access the spine for a fusion procedure from the side of the patients body,
rather than from the front or back. The execution of our strategy of expanding our product offering
for the lumbar region and addressing broader indications further up the spine in the thoracic and
cervical regions has contributed to strong revenue growth. In addition, increased market acceptance
in our international markets contributed to the increase in revenues noted for the periods
presented. We expect the continued adoption of our XLIF procedure and deeper penetration into
existing accounts and our newer international markets as our sales force executes on the strategy
of selling the full mix of our products; however, recent changes in payer and hospital behavior in
the United States have created less predictability in the U.S. lumbar portion of the spine market
and impacted the overall spine markets growth rate. Accordingly, we believe that our growth in
revenue in 2011 will be more weighted towards increased sales of our cervical offerings, our
biologics product line and in our international businesses.
Our total revenues increased $13.4 million and $28.8 million in the three and six months ended
June 30, 2011, respectively, representing total revenue growth of 11% and 13% for the three and six
months ended June 30, 2011, respectively, compared to the same periods in 2010. Revenue from our
Spine Surgery Products increased $10.9 million and $23.6 million, or 11% and 13%, in the three and
six months ended June 30, 2011, respectively compared to the same periods in 2010. Revenue from our
Biologics product line increased $2.5 million and $5.1 million, or 11% and 12%, in the three and
six months ended June 30, 2011, respectively, compared to the same periods in 2010. Total revenues
were impacted by small unfavorable changes in price of approximately 1% and 2% in the three and six
months ended June 30, 2011, respectively, compared to the same periods in 2010.
Cost of Goods Sold, excluding amortization of purchased technology
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
(dollars in thousands) |
|
2011 |
|
2010 |
|
$ Change |
|
% Change |
Three months ended |
|
$ |
25,508 |
|
|
$ |
21,014 |
|
|
$ |
4,494 |
|
|
|
21 |
% |
% of revenue |
|
|
19 |
% |
|
|
18 |
% |
|
|
|
|
|
|
|
|
Six months ended |
|
$ |
49,034 |
|
|
$ |
40,457 |
|
|
$ |
8,577 |
|
|
|
21 |
% |
% of revenue |
|
|
19 |
% |
|
|
18 |
% |
|
|
|
|
|
|
|
|
Cost of goods sold consists of purchased goods, inventory-related costs and royalty expenses.
Cost of goods sold as a percentage of revenue increased slightly for the three and six months
ended June 30, 2011 compared to the same periods in 2010, primarily from an increase in excess and
obsolete inventory reserves associated with several cervical product transitions.
21
We expect cost of goods sold, as a percentage of revenue, to remain consistent for the
remainder of 2011 at approximately 19% due to the expected continued increased revenue contribution
from our lower margin biologics and international businesses, roughly offset by new product
introductions that may capture some price premium.
Operating Expenses
Sales, Marketing and Administrative
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
(dollars in thousands) |
|
2011 |
|
2010 |
|
$ Change |
|
% Change |
Three months ended |
|
$ |
84,323 |
|
|
$ |
77,726 |
|
|
$ |
6,597 |
|
|
|
8 |
% |
% of revenue |
|
|
63 |
% |
|
|
65 |
% |
|
|
|
|
|
|
|
|
Six months ended |
|
$ |
168,543 |
|
|
$ |
152,387 |
|
|
$ |
16,156 |
|
|
|
11 |
% |
% of revenue |
|
|
65 |
% |
|
|
67 |
% |
|
|
|
|
|
|
|
|
Sales, marketing and administrative expenses consist primarily of compensation, commission and
training costs for personnel engaged in sales, marketing and customer support functions;
distributor commissions; depreciation expense for surgical instrument sets; shipping costs; surgeon
training costs; shareowner (employee) related expenses for our administrative functions; and
third-party professional service fees.
The increases in sales, marketing and administrative expenses principally result from growth
in our revenue and the overall growth of the Company, including: expenses that tend to vary based
on revenue such as commissions, depreciation expense for loaned surgical instrument sets, worldwide
sales force headcount and shipping; expenses associated with investments in our worldwide
infrastructure such as operating systems and real estate; legal expenses; and non-sales related
headcount growth, offset by the decrease in depreciation expense due to the change in useful life
of certain surgical instrument sets. As a percentage of revenue, sales, marketing and
administrative expenses decreased slightly for the three and six months ended June 30, 2011
compared to the same periods in 2010 principally as a result of increased operating leverage in our
expenses relative to the 11% and 13% growth in revenue for the three and six months ended June 30,
2011, respectively, compared to the same periods in 2010.
Excluding the impact resulting from a change in an accounting estimate related to the useful
life of certain surgical instrument sets, costs that tend to vary based on revenue increased $4.7
million and $6.8 million for the three and six months ended June 30, 2011, respectively, compared
to the same periods in 2010. These increases include expenses totaling $0.4 million recorded in the
three and six months ended June 30, 2011 resulting from the correction of an immaterial error related to
the accrual of payroll expenses. This increase is slightly less than our increased revenue growth
of 11% and 13% in the first three and six months of 2011 as compared to the same periods in 2010.
Effective January 1, 2011, we changed the useful life of certain surgical instrument sets from
three to four years. This change, which was accounted for as a change in accounting estimate,
resulted in approximately $2.1 million and $3.8 million less depreciation expense for the three and
six months ended June 30, 2011, respectively, than would have been recorded had the useful life of
these assets not been extended.
Compensation and other shareowner related expenses for our marketing and administrative
support functions increased $1.3 million and $6.6 million for
the three and six months ended June 30, 2011, respectively, compared to the
same periods in 2010 due to increased compensation and other shareowner related expenses resulting
from additions to our headcount. These increases include expenses totaling $0.6 million recorded in the three and six months
ended June 30, 2011 resulting from the correction of an immaterial error related to the accrual of
payroll expenses. Stock-based compensation increased $0.5 million and $2.1 million for the three
and six months ended June 30, 2011, respectively, compared to the same periods in 2010, primarily
related to an increase in stock-based awards granted to shareowners associated with the continued
increase in headcount and our fiscal 2011 annual grants.
In addition to the items discussed above, acquisition-related costs increased $0.6 million and
$1.2 million for the three and six months ended June 30, 2011, respectively, compared to the same
periods in 2010 primarily attributable to the accretion of the contingent consideration liabilities
incurred in the three and six months ended June 30, 2011, and expenses incurred related to other
acquisition-related activities. In addition, during the three and six months ended June 30, 2010,
expenses were lower due to a recovery
22
of an international receivable totaling $0.5 million and $1.5 million, respectively, for which
no comparable reduction in expenses occurred during the same period in 2011.
On a long-term basis, as a percentage of revenue, we expect total sales, marketing and
administrative costs to continue to decrease moderately over time.
Research and Development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
(dollars in thousands) |
|
2011 |
|
2010 |
|
$ Change |
|
% Change |
Three months ended |
|
$ |
10,258 |
|
|
$ |
11,205 |
|
|
$ |
(947 |
) |
|
|
(8 |
%) |
% of revenue |
|
|
8 |
% |
|
|
9 |
% |
|
|
|
|
|
|
|
|
Six months ended |
|
$ |
21,027 |
|
|
$ |
21,904 |
|
|
$ |
(877 |
) |
|
|
(4 |
%) |
% of revenue |
|
|
8 |
% |
|
|
10 |
% |
|
|
|
|
|
|
|
|
Research
and development expenses consist primarily of product research and development,
clinical trial and study costs, regulatory and clinical functions, and shareowner related expenses.
In the last several years, we have introduced numerous new products and product enhancements
that have significantly expanded our MAS platform, enhanced the applications of the XLIF procedure,
expanded our offering of cervical products, and moved us closer to entering into the growing motion
preservation market. We have also acquired complementary and strategic assets and technology,
particularly in the area of biologics. We are developing proprietary total disc replacement devices
for lateral lumbar spine applications and separately for cervical spine applications, which are
currently in different phases of clinical trials and related studies. We anticipate continuing to
incur costs related to such clinical trials and studies through at least 2011.
Compensation and other shareowner related expenses, including stock-based compensation,
decreased $0.3 million for the three months ended June 30, 2011 compared to the same period in 2010
($0.6 million excluding the impact of expenses totaling $0.3 million recorded in the three months
ended June 30, 2011 resulting from the correction of an immaterial error related to the accrual of
payroll expenses) primarily due to a decrease in performance-based compensation and stock-based
compensation, offset by increased compensation and other shareowner related expenses resulting from
additions to the Companys headcount to support our product development and enhancement efforts.
Compensation and other shareowner related expenses, including stock-based compensation, increased
$0.6 million for the six months ended June 30, 2011 compared to the same period in 2010 ($0.3
million excluding the impact of expenses totaling $0.3 million recorded in the three months ended
June 30, 2011 resulting from the correction of an immaterial error related to the accrual of
payroll expenses) primarily due to increased compensation and other shareowner related expenses
resulting from additions to the Companys headcount to support our product development and
enhancement efforts, offset by a decrease in stock-based compensation.
In addition to the items discussed above, expenses for the three and six months ended June 30,
2011 decreased by $1.2 million and $2.0 million, respectively, compared to the same periods in 2010
due to decreased expenses incurred in connection with various clinical trials and studies, which
include our PCM cervical disc system. These decreases were offset by an increase in expenses of
$0.5 million for the three and six months ended June 30, 2011 compared to the same periods in 2010
related to an asset acquisition-related milestone payment in 2011.
For the foreseeable future, as a percentage of revenue, we expect total research and
development costs to remain around 8% in support of our ongoing development and planned clinical
trial and study related activities.
Amortization of Intangible Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
(dollars in thousands) |
|
2011 |
|
2010 |
|
$ Change |
|
% Change |
Three months ended: |
|
$ |
1,395 |
|
|
$ |
1,355 |
|
|
$ |
40 |
|
|
|
3 |
% |
% of total revenue |
|
|
1 |
% |
|
|
1 |
% |
|
|
|
|
|
|
|
|
Six months ended: |
|
$ |
2,737 |
|
|
$ |
2,705 |
|
|
$ |
32 |
|
|
|
1 |
% |
% of total revenue |
|
|
1 |
% |
|
|
1 |
% |
|
|
|
|
|
|
|
|
23
Amortization of intangible assets relates to amortization of finite-lived intangible assets
acquired. Although amortization expense for the three and six months ended June 30, 2011 compared
to the same periods in 2010 remained relatively constant, we expect expenses recorded in connection
with the amortization of intangible assets to continue to increase in absolute dollars for the
foreseeable future as amortization of acquired in-process research and development commences once
acquired research and development projects reach technological feasibility.
Interest and Other Expense, Net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
(dollars in thousands) |
|
2011 |
|
2010 |
|
$ Change |
|
% Change |
Three months ended: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
$ |
151 |
|
|
$ |
178 |
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
(1,915 |
) |
|
|
(1,668 |
) |
|
|
|
|
|
|
|
|
Other income (expense), net |
|
|
80 |
|
|
|
(30 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total interest and other expense, net |
|
$ |
(1,684 |
) |
|
$ |
(1,520 |
) |
|
$ |
164 |
|
|
|
11 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of revenue |
|
|
1 |
% |
|
|
1 |
% |
|
|
|
|
|
|
|
|
Six months ended: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
$ |
334 |
|
|
$ |
367 |
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
(3,686 |
) |
|
|
(3,337 |
) |
|
|
|
|
|
|
|
|
Other income, net |
|
|
577 |
|
|
|
87 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total interest and other expense, net |
|
$ |
(2,775 |
) |
|
$ |
(2,883 |
) |
|
$ |
(108 |
) |
|
|
(4 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of revenue |
|
|
1 |
% |
|
|
1 |
% |
|
|
|
|
|
|
|
|
Interest and other expense, net, consists primarily of interest income earned on marketable
securities offset by interest expense incurred primarily related to our outstanding $230.0 million
Senior Convertible Notes. Interest and other expense, net, for the three and six months ended June
30, 2011 compared to the same periods in 2010 remained relatively constant.
Interest and other expense, net, is expected to increase in the foreseeable future as a result
of the additional cash and non-cash interest expense associated with the 2017 Notes offering which closed on June 28, 2011.
Income Tax Expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
(dollars in thousands) |
|
2011 |
|
2010 |
|
$ Change |
|
% Change |
Three months ended: |
|
$ |
4,776 |
|
|
$ |
574 |
|
|
$ |
4,202 |
|
|
|
732 |
% |
Effective income tax rate |
|
|
49 |
% |
|
|
8 |
% |
|
|
|
|
|
|
|
|
Six months ended: |
|
$ |
6,316 |
|
|
$ |
1,439 |
|
|
$ |
4,877 |
|
|
|
339 |
% |
Effective income tax rate |
|
|
47 |
% |
|
|
17 |
% |
|
|
|
|
|
|
|
|
We recorded income tax expense of $4.8 million and $0.6 million for the three months ended
June 30, 2011 and 2010, respectively, and $6.3 million and $1.4 million for the six months ended
June 30, 2011 and 2010, respectively. The effective income tax rate for the six months ended June
30, 2011 was 47%, which is based on an estimate of our annual effective income tax rate. We update
our annual effective income tax rate each quarter and if the estimated effective income tax rate
changes, a cumulative adjustment is made. Our annual effective income tax rate for 2011 is expected
to be higher than the U.S. federal statutory rate of 35% primarily due to state income taxes, net
of federal benefit, estimates for certain non-deductible expenses, and foreign losses expected to
be incurred for which no benefit can be recorded.
We expect our effective income tax rate to continue to exceed the U.S. federal and
state statutory income tax rates primarily due to non-deductible expenses
and foreign losses expected to be incurred by Progentix.
24
Stock-Based Compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
(dollars in thousands) |
|
2011 |
|
2010 |
|
$ Change |
|
% Change |
Three months ended: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales, marketing and administrative expense |
|
$ |
7,124 |
|
|
$ |
6,672 |
|
|
|
|
|
|
|
|
|
Research and development expense |
|
|
601 |
|
|
|
877 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stock-based compensation expense |
|
$ |
7,725 |
|
|
$ |
7,549 |
|
|
$ |
176 |
|
|
|
2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of revenue |
|
|
6 |
% |
|
|
6 |
% |
|
|
|
|
|
|
|
|
Six months ended: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales, marketing and administrative expense |
|
$ |
14,459 |
|
|
$ |
12,352 |
|
|
|
|
|
|
|
|
|
Research and development expense |
|
|
1,212 |
|
|
|
1,631 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stock-based compensation expense |
|
$ |
15,671 |
|
|
$ |
13,983 |
|
|
$ |
1,688 |
|
|
|
12 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of revenue |
|
|
6 |
% |
|
|
6 |
% |
|
|
|
|
|
|
|
|
Stock-based compensation related to stock awards is recognized and amortized on an accelerated
basis in accordance with authoritative guidance. The increase in stock-based compensation of
approximately $0.2 million and $1.7 million for the three and six months ended June 30, 2011 is
primarily attributed to an increase in the number of awards granted to shareowners associated with
the continued increase in headcount year over year for the periods presented, and the fiscal 2011
annual grants that occurred during the three months ended March 31, 2011.
Liquidity, Cash Flows and Capital Resources
Since our inception in 1997, we have incurred significant losses and as of June 30, 2011, we
had an accumulated deficit of approximately $103.7 million. Through 2008, our operations were
funded primarily with proceeds from the sale of our equity securities, which at December 31, 2008,
totaled $284.5 million since inception, including $210.1 million sold in the public markets. Since
2009, our operations have been funded primarily with proceeds from
our convertible debt financing issued in March
2008, as well as the positive cash flow generated from operations.
In March 2008, we issued $230.0 million principal amount of 2.25% Senior Convertible Notes due
2013 (the 2013 Notes). The net proceeds from the offering, after deducting the initial purchasers
discounts and costs directly related to the offering, were approximately $208.4 million. We pay
2.25% interest per annum on the principal amount of the 2013 Notes, payable semi-annually in
arrears in cash on March 15 and September 15 of each year.
Any 2013 Notes not converted prior to March
15, 2013, the maturity date, will be paid in cash.
In June 2011, we issued $402.5 million principal amount of the 2017 Notes, which includes the
issuance of $52.5 million principal amount upon the exercise of the initial purchasers option to
purchase additional notes. The net proceeds from the offering, after deducting initial purchasers
discounts and costs directly related to the offering, were approximately $359.0 million. We pay
2.75% interest per annum on the principal amount of the 2017 Notes. The 2017 Notes mature on July
1, 2017 and may be settled only in cash, unless stockholder approval is obtained to increase the
number of our authorized shares of common stock to allow for conversion of the notes and the exercise
of warrants issued in connection with the debt offering. Interest on the 2017 Notes began accruing
in June 2010 and is payable semi-annually each January 1st and July 1st,
beginning January 1, 2012.
In addition, as more fully discussed in Note 14 to the unaudited condensed consolidated
financial statements included in this Report, we were required to escrow funds to secure the recent
$60.0 million judgment against us in connection with the NeuroVision trademark infringement
litigation. On June 16, 2011, we entered into an escrow arrangement and transferred $62.5 million
of cash and investments, representing the $60.0 million judgment amount, plus interest, attorneys
fees and costs, into a restricted escrow account. These funds are included in restricted cash and
investments in our June 30, 2011 condensed consolidated balance sheet.
Cash, cash equivalents and marketable securities was $524.2 million and $229.7 million at June
30, 2011 and December 31, 2010, respectively. We believe that our existing cash, cash equivalents
and short-term marketable securities will be sufficient to meet our anticipated cash needs for at
least the next 12 months. Our future capital requirements will depend on many factors including our
rate of revenue growth, the timing and extent of spending to support development efforts, the
expansion of sales, marketing and administrative activities, the timing of introductions of new
products and enhancements to existing products, the continuing market
acceptance of our products and the expenditures associated with possible future acquisitions
or other business combination transactions.
25
We expect that cash provided by operating activities may fluctuate in future periods as a
result of a number of factors, including fluctuations in our operating results and working capital
requirements. We have historically invested our cash primarily in U.S. treasuries and government
agencies, corporate debt, money market funds, and commercial paper meeting certain criteria.
Certain of these investments are subject to general credit, liquidity and other market risks. The
general condition of the financial markets and the economy has exacerbated those risks and may
affect the value of our current investments and restrict our ability to access the capital markets
or even our own funds.
Cash Flows
The following table summarizes, for the periods indicated, selected items in our condensed consolidated
statements of cash flows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
2011 |
|
2010 |
|
$ Change |
Six months ended: |
|
|
|
|
|
|
|
|
|
|
|
|
Cash provided by operating activities |
|
$ |
27,694 |
|
|
$ |
25,461 |
|
|
$ |
2,233 |
|
Cash provided by (used in) investing activities |
|
|
21,597 |
|
|
|
(29,046 |
) |
|
|
50,643 |
|
Cash provided by financing activities |
|
|
363,126 |
|
|
|
5,851 |
|
|
|
357,275 |
|
Effect of exchange rate changes on cash |
|
|
70 |
|
|
|
(166 |
) |
|
|
236 |
|
|
|
|
|
|
|
|
|
|
|
Increase in cash and cash equivalents |
|
$ |
412,487 |
|
|
$ |
2,100 |
|
|
$ |
410,387 |
|
|
|
|
|
|
|
|
|
|
|
Cash flows from operating activities
Cash provided by operating activities was $27.7 million for the six months ended June 30,
2011, as compared to $25.5 million for the same period in 2010. The $2.2 million increase in cash
provided by operating activities for the six months ended June, 30 2011 as compared to the same
period in 2010 is primarily due to improved collections from accounts receivable, a decrease in
amounts paid to shareowners, and an increase in net income, adjusted for noncash items, offset by
the use of $7.9 million more cash to build inventory.
Cash flows from investing activities
Cash provided by investing activities was $21.6 million for the six months ended June 30,
2011, as compared to cash used in investing activities of $29.0 million for the same period in
2010. The $50.6 million increase in cash provided by investing activities for the six months ended
June, 30 2011 as compared to the same period in 2010 is primarily due to a net increase in our net
sales of marketable securities of $66.2 million, offset by payments made in connection with a
supply agreement, restricted cash investments, and increased purchases of surgical instrument sets
which are deployed to support our increasing revenue volume.
Cash flows from financing activities
Cash provided by financing activities was $363.1 million for the six months ended June 30,
2011, as compared to $5.9 million for the same period in 2010. The $357.3 million increase in cash
provided by financing activities for the six months ended June 30, 2011 as compared to the same
period in 2010 is primarily due to net proceeds totaling approximately $359.0 million from the
issuance of $402.5 million Senior Convertible Notes on June 28, 2011.
Contractual Obligations and Commitments
Contractual obligations and commitments represent future cash commitments and liabilities
under agreements with third parties, including our Senior Convertible Notes, operating leases and
other contractual obligations. Our future contractual obligations and commitments are discussed in
our Annual Report on Form 10-K for the fiscal year ended December 31, 2010 and there have been no
material changes during the six months ended June 30, 2011 except as follows:
In June 2011, we issued $402.5 million principal amount of the 2017 Notes. We pay 2.75% interest per annum on the
26
principal amount of the 2017 Notes. The 2017 Notes mature on July 1, 2017 and may be settled
only in cash, unless stockholder approval is obtained to increase the number of our authorized
shares of common stock to allow for conversion of the notes and the exercise of warrants issued in
connection with the debt offering. Interest on the 2017 Notes began accruing in June 2010 and is
payable semi-annually each January 1st and July 1st, beginning January 1,
2012.
Critical Accounting Policies and Estimates
Our discussion and analysis of our financial condition and results of operations is based upon
our unaudited condensed consolidated financial statements, which have been prepared in accordance
with accounting principles generally accepted in the United States (GAAP). The preparation of these
financial statements requires us to make estimates and judgments that affect the reported amounts
of assets, liabilities, revenues and expenses. On an ongoing basis, we evaluate our estimates
including those related to bad debts, inventories, valuation of goodwill, intangibles and other
long-term assets, income taxes, stock-based compensation, and legal proceedings. We base our
estimates on historical experience and on various other assumptions we believe to be reasonable
under the circumstances, the results of which form the basis for making judgments about the
carrying values of assets and liabilities not readily apparent from other sources. Actual results
may differ from these estimates. Our critical accounting policies and estimates are discussed in
our Annual Report on Form 10-K for the fiscal year ended December 31, 2010 and there have been no
material changes during the six months ended June 30, 2011 except as follows:
Change in Accounting Estimate
Effective January 1, 2011, we changed the estimated useful lives of instrument sets that we
loan to or place with hospitals from three to four years.
Financial Instruments and Fair Value
Inputs to valuation techniques are observable or unobservable. Observable inputs reflect
market data obtained from independent sources, while unobservable inputs reflect our market
assumptions. These two types of inputs have created the following fair-value hierarchy:
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.
This hierarchy requires us to minimize the use of unobservable inputs and to use observable
market data, if available, when determining fair value. We recognize transfers between levels of
this hierarchy based on the fair values of the respective financial instruments at the end of the
reporting period in which the transfer occurred. Changes in fair value are recognized in earnings
each period for financial instruments that are carried at fair value.
The types of instruments that trade in markets that are not considered to be active, but are
valued based on quoted market prices, broker or dealer quotations, or alternative pricing sources
with reasonable levels of price transparency are generally classified within Level 2 of the fair
value hierarchy.
As more fully discussed in Notes 2 and 5 to the unaudited condensed consolidated
financial statements included in this Report, in June 2011, in connection with the offering of the
2017 Notes, we entered into convertible note hedge transactions, and recorded an embedded
conversion derivative liability. The fair values of these derivatives are determined using an
option pricing model based on unobservable inputs and are classified
within Level 3. The significant
inputs to the model include our stock price, risk free interest rate,
bond yield, credit rating,
and expected volatility of our stock price.
Certain contingent consideration liabilities are classified within Level 3 of the fair value
hierarchy because they use unobservable inputs. For those liabilities, fair value is determined
using a probability-weighted discounted cash flow model, the significant inputs which are not
observable in the market.
27
New accounting requirements
Effective January 1, 2011, we adopted the FASBs updated guidance related to fair value
measurements and disclosures, which requires a reporting entity to disclose separately information
related to purchases, sales, issuances, and settlements in the reconciliation for fair value
measurements using significant unobservable inputs, or Level 3, to be included in the rollforward
of activity. The guidance is effective for interim or annual financial reporting periods beginning
after December 15, 2010. The Company has updated its disclosures to comply with the updated
guidance; however, adoption of the updated guidance did not have an impact on our consolidated
results of operations or financial position.
Off-Balance Sheet Arrangements
We have not engaged in any off-balance sheet activities.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
There has been no material change in the Companys assessment of its sensitivity to market
risk since its presentation set forth in Item 7A, Quantitative and Qualitative Disclosures About
Market Risk, in its Annual Report on Form 10-K for the fiscal year ended December 31, 2010.
Item 4. Controls and Procedures
Disclosure Controls and Procedures. We maintain disclosure controls and procedures that are
designed to ensure that information required to be disclosed in our reports under the Securities
Exchange Act of 1934, as amended (Exchange Act), is recorded, processed, summarized and reported
within the timelines specified in the SECs rules and forms, and that such information is
accumulated and communicated to our management, including our Chief Executive Officer and Chief
Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. In
designing and evaluating the disclosure controls and procedures, management recognized that any
controls and procedures, no matter how well designed and operated, can only provide reasonable
assurance of achieving the desired control objectives, and in reaching a reasonable level of
assurance, management necessarily was required to apply its judgment in evaluating the cost-benefit
relationship of possible controls and procedures.
Under the supervision and with the participation of our management, including our Chief
Executive Officer and our Chief Financial Officer, we carried out an evaluation of the
effectiveness of the Companys disclosure controls and procedures (as such term is defined in
Exchange Act Rules 13a 15(e) and 15d 15(e)) as of June 30, 2011. Based on such evaluation,
our management has concluded that as of June 30, 2011, the Companys disclosure controls and
procedures are effective.
Changes in Internal Control over Financial Reporting. There has been no change to our internal
control over financial reporting during our most recent fiscal quarter that has materially
affected, or is reasonably likely to materially affect, our internal control over financial
reporting.
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
There have been no material changes to the Legal Proceedings discussed in our Annual Report on
Form 10-K for the fiscal year ended December 31, 2010, except as follows:
As reported by us previously, Medtronic Sofamor Danek USA, Inc. and its related entities
(Medtronic), on August 18, 2008, filed a patent infringement lawsuit against NuVasive in the United
States District Court for the Southern District of California, alleging that certain of NuVasives
products or methods, including the XLIF® procedure, infringe, or contribute to the infringement of,
twelve U.S. patents. Three of the patents were later withdrawn by Medtronic leaving the following
nine patents in the lawsuit: Nos. 5,860,973; 5,772,661; 6,936,051; 6,936,050; 6,916,320; 6,945,933;
6,969,390; 6,428,542; 6,592,586 assigned or licensed to Medtronic (Medtronic Patents). Medtronic is
seeking monetary damages and a court injunction against future infringement by NuVasive. NuVasive
has answered the complaint denying the allegations, and filed counterclaims seeking dismissal of
Medtronics complaint and a declaration that NuVasive has not infringed and currently does not
infringe any valid claim of the Medtronic Patents.
28
Additionally, NuVasive has made counterclaims against Medtronic seeking the following relief:
(i) Medtronic being permanently enjoined from charging that NuVasive has infringed or is infringing
the Medtronic Patents; (ii) a declaration that the Medtronic Patents are invalid; (iii) a
declaration that the 5,860,973 and 5,772,661 patents are unenforceable due to inequitable conduct;
and (iv) costs and reasonable attorneys fees.
NuVasive filed an amended counterclaim on September 4, 2009, alleging that NuVasives U.S.
Patent Nos. 7,207,949; 7,582,058; and 7,470,236 are being infringed by Medtronics NIM-Eclipse
System and accessories and Quadrant products, and DLIF (Direct Lateral Interbody Fusion) surgical
technique. Medtronic, on June 23, 2009, filed a request for inter partes reexamination with the
Patent Office on NuVasives U.S. Patent No. 7,207,949. On October 14, 2009, Medtronic filed a
request for inter partes reexamination on NuVasives U.S. Patent No. 7,582,058. The Patent Office
granted both requests and issued rejections of the claims. Both reexaminations are pending.
Given the number of patents asserted in the litigation, the parties agreed to proceed on a
limited number of patents. The court determined to proceed only with patents that are not the
subject of active reexamination proceedings. As a result, the initial phase of the case includes
three Medtronic patents and one NuVasive patent. Trial on the initial phase of the case is
scheduled to begin August 30, 2011, and is expected to proceed expeditiously. A full schedule for
the second phase of the lawsuit has not yet been set by the Court. We cannot determine or predict
the probable outcome of this litigation and have therefore not recorded a loss contingency related
to this litigation.
Trademark Infringement Litigation
In September 2009, Neurovision Medical Products, Inc. (NMP) filed suit against NuVasive in the
U.S. District Court for the Central District of California (Case No. 2:09-cv-06988-R-JEM) alleging
trademark infringement and unfair competition. NMP sought cancellation of NuVasives NeuroVision
trademark registrations, injunctive relief and damages based on NMPs common law use of the
Neurovision mark. On November 23, 2009, the Company denied the allegations in NMPs complaint.
After trial of the matter, on October 25, 2010 an unfavorable jury verdict was delivered against
the Company relating to its use of the NeuroVision trade name. The verdict awarded damages to NMP
of $60.0 million. On January 3, 2011, the Court ordered a judgment be entered in the case in the
amount of $60.0 million, and granted a permanent injunction prohibiting the Companys use of the
NeuroVision name for marketing purposes. The Company sought emergency relief, and on February 3,
2011, the Ninth Circuit Court of Appeals stayed enforcement of the injunction, and has consolidated
this issue with our appeal of the verdict. During pendency of the appeal, the Company has been
required to escrow funds to secure the amount of the judgment, plus interest, attorneys fees and
costs. On June 16, 2011, the Company entered into an escrow arrangement and transferred $62.5
million of cash and investments into a restricted escrow account. Any payment of damages will be
delayed while the appeals process runs its course, which could take up to two years. The Company
continues to believe that the verdict is not supported by the facts or by applicable law. The
Company, based on its own assessment as well as that of outside counsel, believes that the trial
court committed a number of prejudicial legal errors and that these errors were significant, making
the possibility of reversal of the judgment on appeal and/or a new trial probable. Accordingly, at
June 30, 2011, in accordance with the authoritative guidance on the evaluation of contingencies,
the Company has not recorded an accrual related to this litigation. The Company may be required to
record an expense related to this damage award in the future.
Item 1A. Risk Factors
Except as set forth below, there have been no material changes to the risk factors previously
disclosed in our Annual Report on Form 10-K for the year ended
December 31, 2010, as updated and supplemented by the risk
factors included in our Prospectus dated June 22, 2011 filed pursuant
to Rule 424(b)(5) of the Securities Act of 1933, as amended, with the
Securities and Exchange Commission on June 23, 2011 (the Prospectus).
For additional
information regarding our risk factors, please see Item 1A of Part I of our Annual Report on Form
10-K for the year ended December 31, 2010 and the section titled Risk Factors included in the
Prospectus, which are incorporated herein by reference.
29
Risks Related to Our Financial Results and Need for Financing
The sale of our 2.75% Senior Convertible Notes due 2017 significantly increased our amount of
long-term debt, and our financial condition and results of operations could be adversely affected
if we do not effectively manage our liabilities.
As described in more detail in Note 7 to our unaudited condensed consolidated financial
statements, in June 2011, we issued $402,500,000 aggregate principal amount of our 2.75%
convertible senior Notes due 2017 (the 2017 Notes). As a result of the sale of the 2017 Notes, we
have a substantially greater amount of long-term debt than we have maintained in the past. Our
maintenance of such increased level of debt could adversely affect our flexibility to take
advantage of corporate opportunities and could adversely affect our financial condition and results
of operations.
Conversion of the 2017 Notes, including under the conditional conversion features of the 2017
Notes, if triggered, may adversely affect our financial condition and operating results.
The conversion of some or all of the 2017 Notes and any sales in the public market of our
common stock issued upon such conversion could adversely affect the market price of our common
stock. In addition, the existence of the 2017 Notes may encourage short selling by market
participants because the conversion of the 2017 Notes could depress our common stock price.
In the event the conditional conversion features of the 2017 Notes are triggered, holders of
2017 Notes will be entitled to convert the 2017 Notes during specified periods at their option. If
one or more holders elect to convert their 2017 Notes, unless we receive certain necessary
stockholder approvals and we elect to satisfy our conversion obligation by delivering solely shares
of our common stock, we would be required to settle a portion or all of our conversion obligation
through the payment of cash, which could adversely affect our liquidity. In addition, even if
holders do not elect to convert their 2017 Notes, we could be required under applicable accounting
rules to reclassify all or a portion of the outstanding principal of the 2017 Notes as a current
rather than long-term liability, which would result in a material reduction of our net working
capital.
Our failure to obtain the requisite stockholder approvals pursuant to the terms of the 2017 Notes
and warrants issued in connection therewith could affect our liquidity, financial position and
results of operations.
As
described in more detail in Notes 2 and 7 to our unaudited condensed consolidated financial
statements, in connection with the issuance of the 2017 Notes, we
entered into convertible note hedge transactions (the 2017 Hedge) and issued warrants (the 2017
Warrants) that are exercisable into a number of shares of a new series of our preferred stock,
called the Series A participating preferred stock (the Series A Preferred Stock), based on the
amount, if any, by which the market price per share of our common stock exceeds the strike price of
the 2017 Warrants during a measurement period at the maturity of the 2017 Warrants. Pursuant to
the terms of the 2017 Notes and 2017 Warrants, we agreed to use our best efforts to hold a meeting
of our stockholders as soon as practicable, but not later than June 1, 2012, at which we would seek
to obtain the requisite stockholder approval to (i) amend our Restated Certificate of Incorporation
to increase the number of authorized but unissued shares of our common stock to permit (1) the
conversion and settlement of all 2017 Notes into shares of our common stock and (2) the conversion
and settlement, through the delivery of shares of our common stock, of the maximum number of shares
of the Series A Preferred Stock issuable upon exercise of the 2017 Warrants and (ii) authorize such
conversion and settlement of the Series A Preferred Stock in accordance with NASDAQ Stock Market
Rule 5635. If we do not obtain the requisite stockholder approval for these matters:
|
|
|
the 2017 Notes will not be convertible into shares of our common stock, and we will be
required to satisfy our conversion obligation under the 2017 Notes solely in cash; |
|
|
|
|
a gain (or loss) will be reported in our consolidated
statement of income to the
extent the valuation of the conversion option of the 2017 Notes or
the 2017 Hedge changes from the previous
period for each financial statement period after issuance of the 2017
Notes or the 2017 Hedge, as applicable; |
|
|
|
|
the Series A Preferred Stock issuable upon settlement of the 2017 Warrants will not
convert into shares of our common stock and will accumulate cumulative cash dividends at a
rate of up to 16% per annum for so long as such shares remain outstanding; |
|
|
|
|
after June 1, 2012, in addition to the common stock issuable upon conversion of each
share of Series A Preferred Stock at the then-applicable conversion rate, on the conversion
date, we will pay to the holders to whom we deliver the shares of our common stock due upon
conversion cash dividends in an amount equal to all accumulated and unpaid dividends on
such share of Series A Preferred Stock, whether or not declared prior to such conversion
date, for the then-current dividend period (or portion thereof) ending on such conversion
date and all prior dividend periods, if any (other than previously declared dividends on
such share of Series A Preferred Stock that were paid to the holder of record of such share
of Series A Preferred Stock as of a prior date) to the extent we are lawfully permitted to
pay such dividends under Delaware law; and |
|
|
|
|
upon exercise of the 2017 Warrants, the Series A Preferred Stock will remain outstanding
and include those rights and preferences set forth in the Series A Preferred Stock
certificate of designations, including, but not limited to rights ranking senior to our
common stock with respect to dividends and liquidation rights. |
30
As a result, our failure to obtain the requisite stockholder approval pursuant to the terms of
the 2017 Notes and 2017 Warrants could affect our liquidity, financial position and results of
operations.
In
addition, if we fail to obtain stockholder approval prior to June 1,
2012, we intend to (i) continue to seek to obtain stockholder approval at each subsequent annual
meeting of our stockholders and (ii) hold at least one special meeting of our stockholders in each
calendar year, beginning with the 2012 calendar year, at which we will seek to obtain such
stockholder approval, in each case, until such approval has been obtained, and we will incur the
costs associated therewith.
Risks Related to Our Intellectual Property and Litigation
We are currently involved in several patent litigation actions, including an action involving
Medtronic, and, if we do not prevail in this action against Medtronic, we could be liable for
past damages and might be prevented from making, using, selling, offering to sell, importing or
exporting certain of our products.
On August 18, 2008, Medtronic Sofamor Danek USA, Inc. and its related entities (Medtronic)
filed suit against NuVasive in the United States District Court for the Southern District of
California, alleging that certain of our products infringe, or contribute to the infringement of,
U.S. patents owned by Medtronic. Medtronic is a large, publicly-traded corporation with
significantly greater financial resources than us.
As further examples of intellectual property risks we face in this industry, on April 20,
2010, we filed a lawsuit against Orthofix, Inc. and its related entities (Orthofix) and
Musculoskeletal Transplant Foundation for infringement of a patent licensed as part of our purchase
of Osteocel Plus®. In December 2010, the parties entered into a license
agreement covering the subject product marketed by Orthofix, Trinity
Evolution®, and the lawsuit was settled by the parties. Similarly, on October
5, 2010, we initiated a patent infringement lawsuit against Globus Medical, Inc. (Globus) to
protect our investment in our XLIF procedure and MaXcess retractor system. The lawsuit against
Globus is in its early stages, and the outcome of this litigation is difficult to predict.
Intellectual property litigation is expensive, complex and lengthy and its outcome is
difficult to predict. A court could enter orders that temporarily, preliminarily or permanently
enjoin us or our customers from modeling, using, selling, offering to sell or importing our current
or future products, or could enter an order mandating that we undertake certain remedial
activities. We may also be subject to negative publicity due to litigation. Pending or future
patent litigation against us or any strategic partners or licensees may force us or any strategic
partners or licensees to stop or delay developing, manufacturing or selling potential products that
are claimed to infringe a third partys intellectual property, unless we develop alternative
non-infringing technology or that party grants us or any strategic partners or licensees rights to
use its intellectual property, and may significantly divert the attention of our technical and
management personnel. In the event that our right to market any of our products is successfully
challenged, or if we fail to obtain a required license or are unable to design around a patent, our
business, financial condition or results of operations could be materially adversely affected. In
such cases, we may be required to obtain licenses to patents or proprietary rights of others in
order to continue to commercialize our products. However, we may not be able to obtain any licenses
required under any patents or proprietary rights of third parties on acceptable terms, or at all,
and any licenses may require substantial royalties or other payments by us. Even if any strategic
partners, licensees or we were able to obtain rights to the third partys intellectual property,
these rights may be non-exclusive, thereby giving our competitors access to the same intellectual
property. Furthermore, if we are found to infringe patent claims of a third party, we may, among
other things, be required to pay damages, including up to treble damages and attorneys fees and
costs, which may be substantial.
An unfavorable outcome for us in patent or other intellectual property litigation could
significantly harm our business if such outcome makes us unable to commercialize some of our
current or potential products or cease some of our business operations. In addition, costs of
defense and any damages resulting from litigation may materially adversely affect our business and
financial results. Litigation may also harm our relationships with existing customers and subject
us to negative publicity, each of which could harm our business and financial results.
31
Item 6. Exhibits
EXHIBIT INDEX
|
|
|
Exhibit No |
|
Description |
|
|
|
3.1
|
|
Restated Certificate of Incorporation (incorporated by reference to our
Quarterly Report on Form 10-Q filed with the Commission on August 13,
2004) |
|
|
|
3.2
|
|
Restated Bylaws (incorporated by reference to our Current Report on
Form 8-K filed with the Commission on December 15, 2008) |
|
|
|
3.3
|
|
Certificate of Designations of Series A Participating Preferred Stock
filed with the Delaware Secretary of State on June 28, 2011
(incorporated by reference to our Current Report on Form 8-K filed with
the Commission on June 29, 2011 (file no. 000-50744-11937104)) |
|
|
|
4.1
|
|
Indenture dated as of June 28, 2011 between the Company and the Trustee
(incorporated by reference to our Current Report on Form 8-K filed with
the Commission on June 29, 2011 (file no. 000-50744-11937104)) |
|
|
|
4.2
|
|
Form of 2.75% Convertible Senior Note due 2017 (included in Exhibit 4.1) |
|
|
|
10.1
|
|
Confirmation for base call option transaction dated as of June 22,
2011, between Bank of America, N.A. and the Company (incorporated by
reference to our Current Report on Form 8-K filed with the Commission
on June 29, 2011 (file no. 000-50744-11937102)) |
|
|
|
10.2
|
|
Confirmation for additional call option transaction dated as of June
24, 2011, between Bank of America, N.A. and the Company (incorporated
by reference to our Current Report on Form 8-K filed with the
Commission on June 29, 2011 (file no. 000-50744-11937102)) |
|
|
|
10.3
|
|
Confirmation for base call option transaction dated as of June 22,
2011, between Goldman, Sachs & Co. and the Company (incorporated by
reference to our Current Report on Form 8-K filed with the Commission
on June 29, 2011 (file no. 000-50744-11937102)) |
|
|
|
10.4
|
|
Confirmation for additional call option transaction, dated as of June
24, 2011, between Goldman, Sachs & Co. and the Company (incorporated by
reference to our Current Report on Form 8-K filed with the Commission
on June 29, 2011 (file no. 000-50744-11937102)) |
|
|
|
10.5
|
|
Confirmation for base warrant transaction, dated as of June 22, 2011,
between Bank of America, N.A. and the Company (incorporated by
reference to our Current Report on Form 8-K filed with the Commission
on June 29, 2011(file no. 000-50744-11937102)) |
|
|
|
10.6
|
|
Confirmation for additional warrant transaction, dated as of June 24,
2011, between Bank of America, N.A. and the Company (incorporated by
reference to our Current Report on Form 8-K filed with the Commission
on June 29, 2011 (file no. 000-50744-11937102)) |
|
|
|
10.7
|
|
Confirmation for base warrant transaction, dated as of June 22, 2011,
between Goldman, Sachs & Co. and the Company (incorporated by reference
to our Current Report on Form 8-K filed with the Commission on June 29,
2011 (file no. 000-50744-11937102)) |
|
|
|
10.8
|
|
Confirmation for additional warrant transaction, dated as of June 24,
2011, between Goldman, Sachs & Co. and the Company (incorporated by
reference to our Current Report on Form 8-K filed with the Commission
on June 29, 2011 (file no. 000-50744-11937102)) |
32
|
|
|
Exhibit No |
|
Description |
10.9#
|
|
Non-Employee Director Cash
Compensation (filed herewith) |
|
|
|
31.1
|
|
Certification of Chief Executive Officer pursuant to Rules 13a-14 and
15d-14 promulgated under the Securities Exchange Act of 1934, as
amended |
|
|
|
31.2
|
|
Certification of Chief Financial Officer pursuant to Rules 13a-14 and
15d-14 promulgated under the Securities Exchange Act of 1934, as
amended |
|
|
|
32*
|
|
Certifications of Chief Executive Officer and Chief Financial Officer
pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906
of the Sarbanes-Oxley Act of 2002 |
|
|
|
101**
|
|
XBRL Instance Document |
|
|
|
101**
|
|
XBRL Taxonomy Extension Schema Document |
|
|
|
101**
|
|
XBRL Taxonomy Calculation Linkbase Document |
|
|
|
101**
|
|
XBRL Taxonomy Definition Linkbase
Document |
|
|
|
101**
|
|
XBRL Taxonomy Label Linkbase Document |
|
|
|
101**
|
|
XBRL Taxonomy Presentation Linkbase Document |
|
|
|
* |
|
These certifications are being furnished solely to accompany this quarterly report pursuant
to 18 U.S.C. Section 1350, and are not being filed for purposes of Section 18 of the
Securities Exchange Act of 1934 and are not to be incorporated by reference into any filing of
NuVasive, Inc., whether made before or after the date hereof, regardless of any general
incorporation language in such filing. |
|
** |
|
Pursuant to applicable securities laws and regulations, we are deemed to have complied with
the reporting obligation relating to the submission of interactive data files in such exhibits
and are not subject to liability under any anti-fraud provisions of the federal securities
laws as long as we have made a good faith attempt to comply with the submission requirements
and promptly amend the interactive data files after becoming aware that the interactive data
files fail to comply with the submission requirements. Users of this data are advised that,
pursuant to Rule 406T, these interactive data files are deemed not filed and otherwise are not
subject to liability. |
|
# |
|
Indicates management contract or compensatory plan or arrangement. |
33
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 5, 2011
|
|
|
|
|
|
|
|
|
By: |
/s/ Alexis V. Lukianov
|
|
|
|
Alexis V. Lukianov |
|
|
|
Chairman and Chief Executive Officer |
|
|
Date: August 5, 2011
|
|
|
|
|
|
|
|
|
By: |
/s/ Michael J. Lambert
|
|
|
|
Michael J. Lambert |
|
|
|
Executive Vice President and Chief Financial Officer |
|
|
34
EXHIBIT INDEX
|
|
|
Exhibit No |
|
Description |
|
|
|
3.1
|
|
Restated Certificate of Incorporation (incorporated by reference to our
Quarterly Report on Form 10-Q filed with the Commission on August 13,
2004) |
|
|
|
3.2
|
|
Restated Bylaws (incorporated by reference to our Current Report on
Form 8-K filed with the Commission on December 15, 2008) |
|
|
|
3.3
|
|
Certificate of Designations of Series A Participating Preferred Stock
filed with the Delaware Secretary of State on June 28, 2011
(incorporated by reference to our Current Report on Form 8-K filed with
the Commission on June 29, 2011 (file no. 000-50744-11937104)) |
|
|
|
4.1
|
|
Indenture dated as of June 28, 2011 between the Company and the Trustee
(incorporated by reference to our Current Report on Form 8-K filed with
the Commission on June 29, 2011 (file no. 000-50744-11937104)) |
|
|
|
4.2
|
|
Form of 2.75% Convertible Senior Note due 2017 (included in Exhibit 4.1) |
|
|
|
10.1
|
|
Confirmation for base call option transaction dated as of June 22,
2011, between Bank of America, N.A. and the Company (incorporated by
reference to our Current Report on Form 8-K filed with the Commission
on June 29, 2011 (file no. 000-50744-11937102)) |
|
|
|
10.2
|
|
Confirmation for additional call option transaction dated as of June
24, 2011, between Bank of America, N.A. and the Company (incorporated
by reference to our Current Report on Form 8-K filed with the
Commission on June 29, 2011 (file no. 000-50744-11937102)) |
|
|
|
10.3
|
|
Confirmation for base call option transaction dated as of June 22,
2011, between Goldman, Sachs & Co. and the Company (incorporated by
reference to our Current Report on Form 8-K filed with the Commission
on June 29, 2011 (file no. 000-50744-11937102)) |
|
|
|
10.4
|
|
Confirmation for additional call option transaction, dated as of June
24, 2011, between Goldman, Sachs & Co. and the Company (incorporated by
reference to our Current Report on Form 8-K filed with the Commission
on June 29, 2011 (file no. 000-50744-11937102)) |
|
|
|
10.5
|
|
Confirmation for base warrant transaction, dated as of June 22, 2011,
between Bank of America, N.A. and the Company (incorporated by
reference to our Current Report on Form 8-K filed with the Commission
on June 29, 2011(file no. 000-50744-11937102)) |
|
|
|
10.6
|
|
Confirmation for additional warrant transaction, dated as of June 24,
2011, between Bank of America, N.A. and the Company (incorporated by
reference to our Current Report on Form 8-K filed with the Commission
on June 29, 2011 (file no. 000-50744-11937102)) |
|
|
|
10.7
|
|
Confirmation for base warrant transaction, dated as of June 22, 2011,
between Goldman, Sachs & Co. and the Company (incorporated by reference
to our Current Report on Form 8-K filed with the Commission on June 29,
2011 (file no. 000-50744-11937102)) |
|
|
|
10.8
|
|
Confirmation for additional warrant transaction, dated as of June 24,
2011, between Goldman, Sachs & Co. and the Company (incorporated by
reference to our Current Report on Form 8-K filed with the Commission
on June 29, 2011 (file no. 000-50744-11937102)) |
|
|
|
10.9#
|
|
Non-Employee Director Cash
Compensation (filed herewith) |
|
|
|
31.1
|
|
Certification of Chief Executive Officer pursuant to Rules 13a-14 and
15d-14 promulgated under the Securities Exchange Act of 1934, as
amended |
|
|
|
31.2
|
|
Certification of Chief Financial Officer pursuant to Rules 13a-14 and
15d-14 promulgated under the Securities Exchange Act of 1934, as
amended |
35
|
|
|
Exhibit No |
|
Description |
|
|
|
32*
|
|
Certifications of Chief Executive Officer and Chief Financial Officer
pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906
of the Sarbanes-Oxley Act of 2002 |
|
|
|
101**
|
|
XBRL Instance Document |
|
|
|
101**
|
|
XBRL Taxonomy Extension Schema Document |
|
|
|
101**
|
|
XBRL Taxonomy Calculation Linkbase Document |
|
|
|
101**
|
|
XBRL Taxonomy Definition Linkbase
Document |
|
|
|
101**
|
|
XBRL Taxonomy Label Linkbase Document |
|
|
|
101**
|
|
XBRL Taxonomy Presentation Linkbase Document |
|
|
|
* |
|
These certifications are being furnished solely to accompany this quarterly report pursuant
to 18 U.S.C. Section 1350, and are not being filed for purposes of Section 18 of the
Securities Exchange Act of 1934 and are not to be incorporated by reference into any filing of
NuVasive, Inc., whether made before or after the date hereof, regardless of any general
incorporation language in such filing. |
|
** |
|
Pursuant to applicable securities laws and regulations, we are deemed to have complied with
the reporting obligation relating to the submission of interactive data files in such exhibits
and are not subject to liability under any anti-fraud provisions of the federal securities
laws as long as we have made a good faith attempt to comply with the submission requirements
and promptly amend the interactive data files after becoming aware that the interactive data
files fail to comply with the submission requirements. Users of this data are advised that,
pursuant to Rule 406T, these interactive data files are deemed not filed and otherwise are not
subject to liability. |
|
# |
|
Indicates management contract or compensatory plan or arrangement. |
36