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, 2009
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
(State or other jurisdiction of
incorporation or organization)
|
|
33-0768598
(I.R.S. Employer
Identification No.) |
7475 Lusk Boulevard
San Diego, CA 92121
(Address of principal executive offices, including zip code)
(858) 909-1800
(Registrants telephone number, including area code)
(Former name, former address and former fiscal year, if changed since last report)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.
Yes þ No o
Indicate by check mark
whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period
that the registrant was required to submit and post such files).
Yes o No o
Indicate by check mark whether
the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer, or a smaller reporting
company. See the definitions of large accelerated filer, accelerated filer and smaller
reporting company in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer þ | Accelerated filer o | Non-accelerated filer o (Do not check if a smaller reporting company) | Smaller reporting company o |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act). Yes o No þ
As of July 31, 2009, there were 37,688,415 shares of the registrants common stock outstanding.
NUVASIVE, INC.
QUARTERLY REPORT ON FORM 10-Q
June 30, 2009
TABLE OF CONTENTS
2
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
NUVASIVE, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
|
(unaudited) |
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
136,326 |
|
|
$ |
132,318 |
|
Short-term marketable securities |
|
|
25,100 |
|
|
|
45,738 |
|
Accounts receivable, net |
|
|
48,528 |
|
|
|
51,622 |
|
Inventory |
|
|
87,130 |
|
|
|
68,834 |
|
Prepaid expenses and other current assets |
|
|
3,825 |
|
|
|
3,466 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
300,909 |
|
|
|
301,978 |
|
Property and equipment, net |
|
|
77,830 |
|
|
|
73,686 |
|
Long-term marketable securities |
|
|
19,351 |
|
|
|
45,305 |
|
Goodwill |
|
|
87,265 |
|
|
|
2,332 |
|
Intangible assets, net |
|
|
105,965 |
|
|
|
54,767 |
|
Other assets |
|
|
7,674 |
|
|
|
9,338 |
|
|
|
|
|
|
|
|
Total assets |
|
$ |
598,994 |
|
|
$ |
487,406 |
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
$ |
21,381 |
|
|
$ |
26,633 |
|
Accrued payroll and related expenses |
|
|
16,464 |
|
|
|
17,132 |
|
Acquisition related liabilities |
|
|
12,350 |
|
|
|
|
|
Royalties payable |
|
|
2,255 |
|
|
|
1,722 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
52,450 |
|
|
|
45,487 |
|
Senior convertible notes |
|
|
230,000 |
|
|
|
230,000 |
|
Long-term acquisition related liabilities |
|
|
29,932 |
|
|
|
12,111 |
|
Other long-term liabilities |
|
|
30,026 |
|
|
|
12,177 |
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
Noncontrolling interests |
|
|
14,317 |
|
|
|
|
|
Stockholders equity: |
|
|
|
|
|
|
|
|
Common stock, $0.001 par value;
70,000 shares authorized, 37,613 and
36,310 issued and outstanding at June
30, 2009 and December 31, 2008,
respectively |
|
|
38 |
|
|
|
36 |
|
Additional paid-in capital |
|
|
439,303 |
|
|
|
383,293 |
|
Accumulated other comprehensive loss |
|
|
(27 |
) |
|
|
(190 |
) |
Accumulated deficit |
|
|
(197,045 |
) |
|
|
(195,508 |
) |
|
|
|
|
|
|
|
Total stockholders equity |
|
|
242,269 |
|
|
|
187,631 |
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity |
|
$ |
598,994 |
|
|
$ |
487,406 |
|
|
|
|
|
|
|
|
See accompanying notes to unaudited condensed consolidated financial statements.
3
NUVASIVE, INC.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2009 |
|
2008 |
|
2009 |
|
2008 |
Revenues |
|
$ |
88,481 |
|
|
$ |
57,417 |
|
|
$ |
168,490 |
|
|
$ |
108,601 |
|
Cost of goods sold |
|
|
16,710 |
|
|
|
9,571 |
|
|
|
31,484 |
|
|
|
18,666 |
|
|
|
|
|
|
Gross profit |
|
|
71,771 |
|
|
|
47,846 |
|
|
|
137,006 |
|
|
|
89,935 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales, marketing and administrative |
|
|
58,149 |
|
|
|
42,099 |
|
|
|
116,630 |
|
|
|
81,416 |
|
Research and development |
|
|
9,200 |
|
|
|
6,426 |
|
|
|
19,393 |
|
|
|
13,402 |
|
In-process research and development |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,176 |
|
|
|
|
|
|
Total operating expenses |
|
|
67,349 |
|
|
|
48,525 |
|
|
|
136,023 |
|
|
|
98,994 |
|
|
|
|
|
|
Interest income |
|
|
383 |
|
|
|
1,777 |
|
|
|
1,115 |
|
|
|
2,913 |
|
Other income (expense), net |
|
|
(433 |
) |
|
|
70 |
|
|
|
(488 |
) |
|
|
94 |
|
Interest expense |
|
|
(2,060 |
) |
|
|
(1,663 |
) |
|
|
(3,830 |
) |
|
|
(2,097 |
) |
|
|
|
|
|
Interest and other income (expense), net |
|
|
(2,110 |
) |
|
|
184 |
|
|
|
(3,203 |
) |
|
|
910 |
|
|
|
|
|
|
Consolidated net income (loss) |
|
$ |
2,312 |
|
|
$ |
(495 |
) |
|
$ |
(2,220 |
) |
|
$ |
(8,149 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to noncontrolling interests |
|
$ |
(453 |
) |
|
$ |
|
|
|
$ |
(683 |
) |
|
$ |
|
|
|
|
|
|
|
Net income (loss) attributable to NuVasive, Inc. |
|
$ |
2,765 |
|
|
$ |
(495 |
) |
|
$ |
(1,537 |
) |
|
$ |
(8,149 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share attributable to NuVasive, Inc.: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net income (loss) per share |
|
$ |
0.07 |
|
|
$ |
(0.01 |
) |
|
$ |
(0.04 |
) |
|
$ |
(0.23 |
) |
|
|
|
|
|
Weighted average shares outstanding basic |
|
|
36,910 |
|
|
|
35,663 |
|
|
|
36,639 |
|
|
|
35,543 |
|
|
|
|
|
|
Weighted average shares outstanding diluted |
|
|
38,301 |
|
|
|
35,663 |
|
|
|
36,639 |
|
|
|
35,543 |
|
|
|
|
|
|
See accompanying notes to unaudited condensed consolidated financial statements.
4
NUVASIVE, INC.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, |
|
|
|
2009 |
|
|
2008 |
|
Operating activities: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(1,537 |
) |
|
$ |
(8,149 |
) |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
12,811 |
|
|
|
8,449 |
|
In-process research and development |
|
|
|
|
|
|
4,176 |
|
Stock-based compensation |
|
|
12,999 |
|
|
|
10,298 |
|
Other non-cash adjustments |
|
|
3,328 |
|
|
|
312 |
|
Noncontrolling interests |
|
|
(683 |
) |
|
|
|
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
2,221 |
|
|
|
(5,044 |
) |
Inventory |
|
|
(19,939 |
) |
|
|
(16,496 |
) |
Prepaid expenses and other current assets |
|
|
(694 |
) |
|
|
(1,707 |
) |
Accounts payable and accrued liabilities |
|
|
(288 |
) |
|
|
3,361 |
|
Accrued payroll and related expenses |
|
|
(652 |
) |
|
|
(1,282 |
) |
|
|
|
|
|
|
|
Net cash provided by (used in) operating activities |
|
|
7,566 |
|
|
|
(6,082 |
) |
Investing activities: |
|
|
|
|
|
|
|
|
Cash paid
for acquisitions (Note 3) |
|
|
(24,055 |
) |
|
|
(6,256 |
) |
Cash paid for investment in Progentix (Note 3) |
|
|
(10,000 |
) |
|
|
|
|
Acquisition related milestone payments |
|
|
(10,000 |
) |
|
|
|
|
Purchases of property and equipment |
|
|
(12,440 |
) |
|
|
(25,686 |
) |
Purchases of short-term marketable securities |
|
|
(12,004 |
) |
|
|
(72,799 |
) |
Sales of short-term marketable securities |
|
|
49,295 |
|
|
|
19,300 |
|
Purchases of long-term marketable securities |
|
|
(17,674 |
) |
|
|
(51,709 |
) |
Sales of long-term marketable securities |
|
|
26,975 |
|
|
|
3,500 |
|
Other assets |
|
|
|
|
|
|
543 |
|
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(9,903 |
) |
|
|
(133,107 |
) |
Financing activities: |
|
|
|
|
|
|
|
|
Payments of long-term liabilities |
|
|
|
|
|
|
(300 |
) |
Issuance of convertible debt, net of costs |
|
|
|
|
|
|
222,414 |
|
Purchase of convertible note hedges |
|
|
|
|
|
|
(45,758 |
) |
Sale of warrants |
|
|
|
|
|
|
31,786 |
|
Issuance of common stock |
|
|
6,297 |
|
|
|
5,356 |
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
6,297 |
|
|
|
213,498 |
|
Effect of exchange rate changes on cash |
|
|
48 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase in cash and cash equivalents |
|
|
4,008 |
|
|
|
74,309 |
|
Cash and cash equivalents at beginning of period |
|
|
132,318 |
|
|
|
61,915 |
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
136,326 |
|
|
$ |
136,224 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of non-cash transactions: |
|
|
|
|
|
|
|
|
Leasehold improvements paid by lessor |
|
|
|
|
|
$ |
2,848 |
|
See accompanying notes to unaudited condensed consolidated financial statements.
5
NuVasive, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements
1. Description of Business
NuVasive, Inc. (the Company or NuVasive) was incorporated in Delaware on July 21, 1997. The
Company is a medical device company focused on the design, development, and marketing of products
for the surgical treatment of spine disorders. The Companys product portfolio is focused primarily
on the U.S. spine implant market. Additionally, the Company has expanded into the global biologics
market, the international market, and is developing products for the emerging motion preservation
market.
NuVasives principal product offering is based on its Maximum Access Surgery, or MAS®
platform. The MAS platform combines four categories of products that collectively minimize soft
tissue disruption during spine surgery with maximum visualization and safe, easy reproducibility
for the surgeon: NeuroVision®, a proprietary software-driven nerve avoidance system; MaXcess®, a
unique split-blade retractor system; a wide variety of specialized implants; and several biologic
fusion enhancers. MAS significantly reduces surgery time and returns patients to activities of
daily living much faster than conventional approaches. Utilizing the
Companys MAS
platforms lateral approach, known as eXtreme Lateral Interbody Fusion, or XLIF®, the Company has
built an entire spine franchise. With products today spanning lumbar, thoracic and cervical
applications, the Company continues to expand and evolve its offering predicated on its research
and development focus and dedication to outstanding service levels supported by a culture of
Absolute Responsiveness®.
The Company loans its MAS systems to surgeons and hospitals that purchase implants and
disposables for use in individual procedures. In addition, NeuroVision, MaXcess and surgical
instrument sets are placed with hospitals for an extended period at no up-front cost to them
provided they commit to minimum monthly purchases of disposables and implants. The Company sells a
small quantity of MAS instrument sets, MaXcess and NeuroVision systems to hospitals. The Company
also offers a range of allograft and spine implants such as rods, plates and screws. Implants and
disposables are shipped from the Companys facilities.
2. Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared
pursuant to the rules and regulations of the Securities and Exchange Commission. Pursuant to these
rules and regulations, the Company has condensed or omitted certain information and footnote
disclosures it normally includes in its annual consolidated financial statements prepared in
accordance with accounting principles generally accepted in the United States (GAAP). In the
opinion of management, the consolidated financial statements include all adjustments necessary,
which are of a normal and recurring nature, for the fair presentation of the Companys financial
position and of the results of operations and cash flows for the periods presented.
The accompanying unaudited condensed consolidated financial statements as of December 31, 2008
and for the three and six months ended June 30, 2008 include the accounts of the Company and its
wholly owned subsidiaries. The unaudited condensed consolidated financial statements as of June 30,
2009 and for the three and six months then ended include the accounts of the Company and its wholly
owned subsidiaries, as well as the accounts of a variable interest entity, Progentix Orthobiology,
B.V. (Progentix), which is consolidated pursuant to Financial Accounting Standards Board (FASB)
Interpretation No. 46 (revised 2003), Consolidation of Variable Interest Entities, or FIN 46R.
There has been no material activity by the Companys subsidiaries during the periods presented. All
significant intercompany accounts and transactions have been eliminated in consolidation.
Effective April 1, 2009, the Company implemented Statement of Financial Accounting Standards
No. 165, Subsequent Events (SFAS 165). This standard establishes general standards of accounting
for and disclosure of events that occur after the balance sheet date but before financial
statements are issued. The adoption of SFAS 165 did not impact the Companys financial position or
results of operations. Management evaluated all events or transactions that occurred after June 30,
2009 up through August 6, 2009, the date on which these financial statements were issued. During
this period, the Company did not have any material recognizable subsequent events.
These financial statements should be read in conjunction with the audited consolidated
financial statements and notes thereto for the year ended December 31, 2008 included in NuVasives
Annual Report on Form 10-K filed with the Securities and Exchange Commission. Operating results for
the three and six months ended June 30, 2009 and 2008 are not necessarily indicative of the results
that may be expected for any other interim period or for the full year. The balance sheet at
December 31, 2008 has been derived from the audited financial statements at that date, but does not
include all of the information and footnotes required by GAAP for complete financial statements.
6
3. Acquisitions and Investments
Cervitech® Inc. Acquisition
On May 8, 2009 (the Closing Date), the Company completed the purchase of all of the
outstanding shares of Cervitech, Inc., a Delaware corporation (Cervitech), pursuant to a Share
Purchase Agreement dated April 22, 2009 (the Purchase Agreement) for an initial payment of
approximately $48 million consisting of cash totaling
approximately $24 million and the issuance of 638,261
shares of NuVasive common stock to certain stockholders of Cervitech. Cervitech, a New Jersey
based company, is focused on the clinical approval of the PCM® cervical disc system, a motion
preserving total disc replacement device in the United States. This acquisition allows NuVasive the
potential to accelerate its entry into the growing mechanical cervical disc replacement market.
In addition to the initial payment, the Company may be obligated to make an additional
milestone payment of $33 million if the U.S. Food and Drug Administration (FDA) issues an approval
order allowing the commercialization of Cervitechs PCM device in the United States with an
intended use for treatment of degenerative disc disease. The milestone payment may be made in cash
or a combination of cash and up to half in NuVasive common stock, at the Companys discretion.
Purchase Price
The acquisition of Cervitech was recorded using the acquisition method of accounting in
accordance with Statement of Financial Accounting Standards No. 141(R), Business Combinations (FAS
141R).
The estimated purchase price is determined as follows (in thousands):
|
|
|
|
|
Cash paid to sellers |
|
$ |
24,055 |
|
Market value of NuVasives common stock issued on Closing Date |
|
|
24,215 |
|
Contingent consideration liability, due on achieving milestone |
|
|
29,722 |
|
|
|
|
|
Total estimated purchase price |
|
$ |
77,992 |
|
|
|
|
|
The arrangement requires the Company to pay an additional amount not to exceed $33 million in
the event that Cervitechs device receives FDA approval. The fair value of the contingent
consideration at the Closing Date was determined to be
$29.7 million using a probability-weighted discounted cash flow model. This fair value measurement is based on
significant inputs not observable in the market. The key assumptions in applying this approach
were the interest rate and the probability assigned to the milestone being achieved. In accordance
with FAS 141R, management will remeasure the fair value of the contingent payment at each reporting
period, with any change in its fair value being recorded in the current periods earnings. Since
the acquisition date, the Company has recorded approximately $0.2 million in interest expense to
reflect the change in the fair value of the consideration liability through June 30, 2009.
The preliminary allocation of the estimated purchase price is based on managements
preliminary valuation of the fair value of tangible, intangible assets and in-process research and
development acquired and liabilities assumed as of the Closing Date and such estimates are subject
to revision. The area of the purchase price allocation that is not yet finalized relates primarily
to the valuation of income tax related assets acquired. Consequently, the amounts recorded at June
30, 2009 are subject to change, and the final amounts may differ. The following table summarizes
the allocation of the estimated initial purchase price (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Estimated |
|
|
Estimated Useful |
|
|
|
Fair Value |
|
|
Life |
|
Total current assets |
|
$ |
1,233 |
|
|
|
|
|
Property, plant and equipment |
|
|
59 |
|
|
|
|
|
Developed technology |
|
|
700 |
|
|
14 years |
Non-compete agreement |
|
|
100 |
|
|
2 years |
Trade name |
|
|
700 |
|
|
10 years |
In-process research and development |
|
|
34,800 |
|
|
14 years |
Goodwill |
|
|
54,825 |
|
|
|
|
|
Current liabilities |
|
|
(483 |
) |
|
|
|
|
Deferred income tax liabilities |
|
|
(13,942 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Total estimated initial purchase price allocation |
|
$ |
77,992 |
|
|
|
|
|
|
|
|
|
|
|
|
|
The Goodwill balance related to the Cervitech Acquisition was $54.8 million as of June 30,
2009. Goodwill represents the excess of the purchase price over the fair value of tangible and
identifiable intangible assets acquired. Of the $54.8 million recorded as goodwill, none is
expected to be deductible for tax purposes.
The accompanying condensed consolidated statement of operations for the three and six months
ended June 30, 2009 reflect the operating results of Cervitech since the date of the acquisition.
The amount of loss attributable to Cervitech included in the Companys consolidated statement of
operations from the acquisition date to the period ended
June 30, 2009 was $0.5 million. For the three and six months ended June 30, 2009, the Companys consolidated results of operations include
acquisition-related expenses of $0.5 million and $1.2 million, respectively, which are included in
sales, marketing and administrative expenses.
7
The Company has prepared the following unaudited pro forma financial statement information to
compare results of the periods presented assuming the Cervitech acquisition had occurred as of
January 1, 2008. These unaudited pro forma results have been prepared for comparative purposes only
and do not purport to be an indicator of the results of operations that would have actually
resulted had the acquisition occurred at the beginning of each of the periods presented, or of
future results of operations. Assuming the Cervitech acquisition occurred as of January 1, 2008,
the pro forma unaudited results of operations would have been as follows for the three and six months ended June 30, 2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
June 30, |
|
June 30, |
|
|
2009 |
|
2008 |
|
2009 |
|
2008 |
|
|
|
|
|
Revenue |
|
$ |
88,677 |
|
|
$ |
57,441 |
|
|
$ |
169,028 |
|
|
$ |
109,903 |
|
Net income (loss) attributable to NuVasive, Inc. |
|
|
1,332 |
|
|
|
(2,206 |
) |
|
|
(2,536 |
) |
|
|
(14,448 |
) |
Net income (loss) per share basic and diluted |
|
$ |
0.04 |
|
|
$ |
(0.06 |
) |
|
$ |
(0.07 |
) |
|
$ |
(0.40 |
) |
The above pro forma unaudited results of operations do not include pro forma adjustments
relating to costs of integration or post-integration cost reductions that may be incurred or
realized by the Company in excess of actual amounts incurred or realized through June 30, 2009.
Investment in Progentix Orthobiology, B.V.
On January 13, 2009, the Company completed the purchase of forty percent (40%) of the capital
stock of Progentix Orthobiology, B.V., a company organized under the laws of the Netherlands
(Progentix), from existing shareholders (the Progentix Shareholders) pursuant to a Preferred Stock
Agreement for $10 million in cash (the Initial Investment). Progentix has as its objective the
development and exploitation of knowledge and products in the field of bone defects and the
recovery of bone tissue in general. Progentix wishes to further extend the existing knowledge and
patent position in the field of Osteoinductive Bone Graft Material Technology. Since inception,
Progentix has incurred approximately $2.6 million in losses.
NuVasive and Progentix also entered into a Senior Secured Facility Agreement dated January 13,
2009, whereby Progentix may borrow up to $5 million from NuVasive to fund ongoing clinical and
regulatory efforts (the Loan). The proceeds of the Loan are to be utilized towards achievement of
all milestones, as defined in the Preferred Stock Purchase Agreement. The Loan accrues interest at
a rate of six percent (6%) per year. Other than its obligations under the Loan, NuVasive is not
obligated to provide additional funding to Progentix. Concurrent with the Preferred Stock Purchase
Agreement, NuVasive, Progentix and the Progentix Shareholders entered into an Option Purchase
Agreement dated January 13, 2009 (the Option Agreement), whereby NuVasive may be obligated (the Put
Option), upon the achievement within two years of certain milestones by Progentix, to purchase the
remaining sixty percent (60%) of capital stock of Progentix from its shareholders for $45 million,
payable in a combination of cash or NuVasive common stock at the Companys sole discretion, subject
to certain adjustments (the Remaining Shares).
NuVasive may also be obligated, in the event that Progentix achieves the milestones
contemplated above within the requisite two-year period, to make additional payments to Progentix
shareholders, excluding NuVasive, of up to an aggregate total of $25 million, payable in a
combination of cash or NuVasive common stock, at the Companys sole discretion, subject to certain
adjustments, upon completion of additional milestones and dependent on NuVasives sales success.
NuVasive also has the right under the Option Agreement to purchase the Remaining Shares (the Call
Option) at any time between the second anniversary and the fourth anniversary of the Option
Agreement (the Option Period) for $35 million, payable in a combination of cash or NuVasive common
stock, at the Companys sole discretion, subject to certain adjustments. In the event NuVasive
achieves in excess of a specified annual sales run rate on Progentix products during the Option
Period, NuVasive may be required to purchase the Remaining Shares for $35 million. NuVasive and
Progentix also entered into a Distribution Agreement dated January 13, 2009, whereby Progentix
appointed NuVasive as its exclusive distributor for certain Progentix products. The Distribution
Agreement will be in effect for a term of ten years unless earlier terminated in accordance with
its terms.
In accordance with FIN 46R, Consolidation of Variable Interest Entities, 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 FIN 46R, NuVasive is
considered its primary beneficiary as NuVasive has the obligation to absorb a majority of the
expected losses and the right to receive a majority of expected residual returns of Progentix.
This conclusion was reached due to the existence of the Put Option and Call Option to acquire the
Remaining Shares at prices that were fixed upon entry into the arrangement, with the specific
prices based upon the achievement of certain milestones within a specified period of time. The
fixed nature of the Put Option and the Call Option limit Progentix Shareholders potential future
returns. Accordingly, the financial position and results of operations of Progentix have been
included in the consolidated financial statements from the date of the Initial Investment.
8
Pursuant to FASB Statement No. 160, Noncontrolling Interests in Consolidated Financial
Statements, an amendment of ARB No. 51 (FAS 160), the equity interests in Progentix not owned by
the Company are reported as noncontrolling interests on the consolidated balance sheet of the
Company. Losses incurred by Progentix are charged to the Company and to the noncontrolling interest
holders based on their ownership percentage. The Remaining Shares and the Option Agreement that was
entered into between NuVasive, Progentix and the Progentix Shareholders are not considered to be
freestanding financial instruments as defined by FASB Statement No. 150, Accounting for Certain
Financial Instruments with Characteristics of Both Liabilities and Equity (FAS 150). Therefore the
Remaining Shares and the Option Agreement are accounted for as a combined unit on the consolidated
financial statements as a redeemable noncontrolling interest that is initially recorded at fair
value and classified as mezzanine equity under the provisions of EITF Topic No. D-98,
Classification and Measurement of Redeemable Securities (EITF D-98).
Pursuant to the provisions of EITF D-98, when the embedded Put Option is exercisable and
therefore the Remaining Shares considered currently redeemable (i.e., at the option of the holder),
the instrument should be adjusted to its maximum redemption amount. If the embedded Put Option is
considered not currently exercisable (e.g., because a contingency has not been met), and it is not
probable that the embedded Put Option will become exercisable, an adjustment is not necessary until
it is probable that the embedded Put Option will become exercisable. At June 30, 2009, the embedded Put Option was not
deemed currently exercisable and therefore the Remaining Shares were not redeemable because the
milestones referred to previously had not been met. Furthermore, at June 30, 2009, as it is not
currently possible to predict the outcome of such milestones, the Company concluded it is not
probable that the milestones will be met and that the Remaining Shares will become redeemable. The
probability of redemption will be reevaluated on a quarterly basis.
In accordance with FIN 46R, we have recorded the identifiable assets, liabilities and
noncontrolling interests in the VIE at their fair value upon initial consolidation. There has been
no material change to the balances consolidated at the date of the Initial Investment, therefore
only the balances consolidated as of June 30, 2009 are included below. Total assets and liabilities
of Progentix as of June 30, 2009 are as follows (in thousands):
|
|
|
|
|
|
|
June 30, 2009 |
Total current assets |
|
$ |
303 |
|
Identifiable intangible assets, net |
|
|
16,580 |
|
Goodwill |
|
|
12,654 |
|
Accounts payable & accrued expenses |
|
|
494 |
|
Deferred tax liabilities |
|
|
4,310 |
|
Noncontrolling interests |
|
|
14,317 |
|
Intangible assets consolidated pursuant to the Progentix investment are included in the
Intangible assets, net balance in the consolidated balance sheet as of June 30, 2009 and consist of
the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
|
|
|
Average |
|
Gross |
|
|
|
|
|
Intangible |
|
|
Amortization |
|
Carrying |
|
Accumulated |
|
Assets, |
|
|
(in years) |
|
Amount |
|
Amortization |
|
Net |
Non-competition agreement |
|
|
2 |
|
|
$ |
300 |
|
|
$ |
68 |
|
|
$ |
232 |
|
Existing technology |
|
|
10 |
|
|
|
5,400 |
|
|
|
252 |
|
|
|
5,148 |
|
In-process research and development |
|
|
|
|
|
|
11,200 |
|
|
|
|
|
|
|
11,200 |
|
|
|
|
|
|
|
|
Total Progentix intangible assets |
|
|
|
|
|
$ |
16,900 |
|
|
$ |
320 |
|
|
$ |
16,580 |
|
|
|
|
|
|
|
|
9
Osteocel Biologics Business Acquisition
On July 24, 2008, NuVasive completed the acquisition of certain assets of Osiris Therapeutics,
Inc. (Osiris) (the Osteocel® Biologics Business Acquisition) for $35 million in cash paid at
closing pursuant to the Asset Purchase Agreement, as amended (the Asset Purchase Agreement). The
completion date of this transaction is referred to as the Technology Closing Date. At the
Technology Closing Date, the Company also entered into a Manufacturing Agreement, as amended
(collectively with the Asset Purchase Agreement, the Agreements) with Osiris. Under the terms of
these Agreements, NuVasive was obligated to make payments of up to $50 million in addition to the
amount paid at closing, including milestone-based contingent payments not to exceed $20.0 million
and non-contingent payments in the amount of $30.0 million.
As of June 30, 2009, the Company has paid $10 million in cash and made an additional payment
of $12.5 million in the form of the issuance of 293,331 shares of NuVasive common stock on June 30,
2009 towards the milestone-based contingent payments. The remaining non-contingent payment of $12.5
million is payable on September 30, 2009 in a combination of cash and NuVasive common stock, at the
Companys election.
The terms of the remaining milestone payment of $15 million under the Agreements are based on
the achievement of a specified sales amount by NuVasive. The remaining unpaid milestone payment may
be made in cash or through the delivery of NuVasive common stock of equivalent value.
The Companys purchase price allocation was updated in the first quarter of 2009 to reflect
the milestone payment of $5 million in March 2009 and to reflect the impact of the amendments made
to the Agreements in March 2009, which eliminated the performance contingencies applicable to $30
million of the $45 million in then-remaining milestones. The Goodwill balance related to the
Osteocel® Biologics Business Acquisition was $18.7 million as of June 30, 2009. Goodwill represents
the excess of the purchase price over the fair value of tangible and identifiable intangible assets
acquired.
Acquisition of Pedicle Screw Technology
In March 2008, NuVasive completed a buy-out of royalty obligations on SpheRx® pedicle
screw
and related technology products and acquired new pedicle screw intellectual property for cash
payments aggregating $6.3 million. Of the aggregate purchase price, $2.1 million, representing the
present value of the expected future cash flows associated with the terminated royalty obligations,
was allocated to intangible assets to be amortized on a straight-line basis over a seven-year
period. The remaining $4.2 million was allocated to in-process research and development (IPR&D) as
the associated projects had not yet reached technological feasibility and had no alternative future
uses.
4. Balance Sheet Reserves
The balances of the reserves for accounts receivable and inventory are as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, 2009 |
|
December 31, 2008 |
Reserves for accounts receivable |
|
$ |
3,242 |
|
|
$ |
1,952 |
|
Reserves for excess and obsolete inventory |
|
|
4,717 |
|
|
|
2,778 |
|
The Companys inventory consists primarily of finished goods disposables and specialized implants.
Inventory is stated at the lower of cost or market and is recorded in cost of goods sold based on a
method that approximates cost. The Company reviews the components of its inventory on a periodic
basis for excess, obsolete or impaired inventory, and records a reserve for the identified items.
10
5. Goodwill and Intangible Assets
A summary of adjustments to the goodwill balance for the six months ended June 30, 2009 is as
follows (in thousands):
|
|
|
|
|
Balance at the beginning of the period |
|
$ |
2,332 |
|
Progentix Investment (Note 3) |
|
|
12,654 |
|
Cervitech Acquisition (Note 3) |
|
|
54,825 |
|
First payment under the Osteocel March 2009 Amendments (Note 3) |
|
|
5,000 |
|
Record non-contingent payment pursuant to Osteocel March 2009
Amendments (Note 3) |
|
|
12,454 |
|
|
|
|
|
Balance at
the end of the period |
|
$ |
87,265 |
|
|
|
|
|
Identifiable intangible assets consisted of the following as of June 30, 2009 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
|
|
|
|
|
Averaged |
|
|
Gross |
|
|
|
|
|
|
|
|
|
Amortization |
|
|
Carrying |
|
|
Accumulated |
|
|
Intangible |
|
|
|
(in years) |
|
|
Amount |
|
|
Amortization |
|
|
Assets, net |
|
|
|
|
Intangible Assets Subject to Amortization: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Trade name and trademarks |
|
|
14 |
|
|
$ |
5,900 |
|
|
$ |
(330 |
) |
|
$ |
5,570 |
|
Customer relationships |
|
|
14 |
|
|
|
9,730 |
|
|
|
(1,798 |
) |
|
|
7,932 |
|
Developed technology |
|
|
14 |
|
|
|
31,975 |
|
|
|
(4,412 |
) |
|
|
27,563 |
|
Manufacturing know-how and trade secrets |
|
|
13 |
|
|
|
20,408 |
|
|
|
(1,508 |
) |
|
|
18,900 |
|
In-process research and development |
|
|
|
|
|
|
46,000 |
|
|
|
|
|
|
|
46,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
114,013 |
|
|
$ |
(8,048 |
) |
|
$ |
105,965 |
|
|
|
|
|
|
|
|
Intangible Assets Not Subject to Amortization: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Goodwill |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
87,265 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Intangible assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
193,230 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Future estimated amortization expense related to acquired intangible assets subject to
amortization is as follows (in thousands):
|
|
|
|
|
Remaining 2009 |
|
$ |
2,781 |
|
2010 |
|
|
5,777 |
|
2011 |
|
|
8,840 |
|
2012 |
|
|
8,817 |
|
2013 |
|
|
8,810 |
|
2014 |
|
|
8,775 |
|
Thereafter |
|
|
62,165 |
|
|
|
|
|
|
|
$ |
105,965 |
|
|
|
|
|
Amortization expense was $1.4 million and $0.5 million for the three months ended June 30,
2009 and 2008, respectively, and $2.7 million and $0.9 million for the six months ended June 30,
2009 and 2008, respectively. In-process research and development will be amortized beginning on the
approval date of the respective acquired products and will be amortized over a weighted average
useful life of 13 years. Through June 30, 2009 no amortization expense has been recorded for IPR&D.
6. Convertible Senior Notes
In March 2008, the Company issued $230.0 million principal amount of 2.25% Convertible Senior
Notes (the Notes), which includes the subsequent exercise of the initial purchasers option to
purchase an additional $30.0 million aggregate principal amount of the Notes. The net proceeds from
the offering, after deducting the initial purchasers discount and costs directly related to the
offering, were approximately $208.4 million. The Company will pay 2.25% interest per annum on the
principal amount of the Notes, payable semi-annually in arrears in cash on March 15 and September
15 of each year. The Notes mature on March 15, 2013 (the Maturity Date). The Company made two
interest payments of approximately $2.7 million each in September 2008 and March 2009.
The Notes will be convertible into shares of the Companys common stock, $0.001 par value per
share, based on an initial conversion rate, subject to adjustment, of 22.3515 shares per $1,000
principal amount of the Notes (which represents an initial conversion price of approximately $44.74
per share). Holders may convert their notes at their option on any day up to and including the
second scheduled trading day immediately preceding the Maturity Date. If a fundamental change to
the Companys business occurs, as defined in the Notes, holders of the Notes have the right to
require that the Company repurchase the Notes, or a portion thereof, at the principal amount plus
accrued and unpaid interest.
11
In connection with the offering of the Notes, the Company entered into convertible note hedge
transactions (the Hedge) with the initial purchasers and/or their affiliates (the Counterparties)
entitling the Company to purchase up to 5.1 million shares of the Companys common stock at an
initial stock price of $44.74 per share, each of which is subject to adjustment. In addition, the
Company sold to the Counterparties warrants to acquire up to 5.1 million shares of the Companys
common stock (the Warrants), subject to adjustment, at an initial strike price of $49.13 per share,
subject to adjustment. The cost of the Hedge that was not covered by the proceeds from the sale of
the Warrants was approximately $14.0 million and is reflected as a reduction of additional paid-in
capital as of June 30, 2009. The impact of the Hedge is to raise the effective conversion price of
the Notes to approximately $49.13 per share (or approximately 20.3542 shares per $1,000 principal
amount of the Notes). The Hedge is expected to reduce the potential equity dilution upon conversion
of the Notes if the daily volume-weighted average price per share of the Companys common stock
exceeds the strike price of the Hedge. The Warrants could have a dilutive effect on the Companys
earnings per share to the extent that the price of the Companys common stock during a given
measurement period (the quarter or year to date period) exceeds the strike price of the Warrants.
7. Net Income (Loss) Per Share
Nuvasive calculates net income (loss) per share in accordance with the Statement of Financial
Accounting Standards No. 128, Earnings Per Share (SFAS 128). SFAS 128 requires presentation of
basic earnings per share and diluted earnings per share. Basic earnings per share (EPS) is
calculated by dividing the net income (loss) by the weighted average number of common shares
outstanding for the period, without consideration for common stock equivalents. Diluted EPS is
computed by dividing net income (loss) by the weighted average number of common shares outstanding
for the period and the weighted average number of dilutive common stock equivalents, such as the
assumed vesting of outstanding unvested restricted stock units, options, and warrants. Common stock
equivalents are only included in the calculation of diluted earnings per share when their effect is
dilutive. There were no potentially dilutive common shares related to the Companys 2.25%
Convertible Senior Notes due 2013, or the related warrants, for the three and six months ended June
30, 2009 and 2008, as the Companys average stock price for the respective periods was less than
the conversion price (approximately $44.74) of the Notes.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
(in thousands, except per share amounts) |
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
Numerator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) attributable to NuVasive, Inc. |
|
$ |
2,765 |
|
|
$ |
(495 |
) |
|
$ |
(1,537 |
) |
|
$ |
(8,149 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator for basic and diluted net loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding for basic |
|
|
36,910 |
|
|
|
35,663 |
|
|
|
36,639 |
|
|
|
35,543 |
|
Dilutive potential common stock outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options |
|
|
1,334 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted stock units |
|
|
57 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding for diluted |
|
|
38,301 |
|
|
|
35,663 |
|
|
|
36,639 |
|
|
|
35,543 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net income (loss) per share
attributable to NuVasive, Inc. shareholders |
|
$ |
0.07 |
|
|
$ |
(0.01 |
) |
|
$ |
(0.04 |
) |
|
$ |
(0.23 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
8. Comprehensive Income (Loss)
The components of comprehensive income (loss) are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months
Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
Net income
(loss) before noncontrolling interests |
|
$ |
2,312 |
|
|
$ |
(495 |
) |
|
$ |
(2,220 |
) |
|
$ |
(8,149 |
) |
Other comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized
loss on investments |
|
|
(27 |
) |
|
|
(142 |
) |
|
|
(299 |
) |
|
|
(116 |
) |
Translation adjustments |
|
|
665 |
|
|
|
(65 |
) |
|
|
462 |
|
|
|
(22 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income (loss) |
|
|
2,950 |
|
|
|
(702 |
) |
|
|
(2,057 |
) |
|
|
(8,287 |
) |
Less:
Amounts attributable to noncontrolling interests |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
(453 |
) |
|
|
|
|
|
|
(683 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive
income (loss) attributable to NuVasive, Inc. shareholders |
|
$ |
2,497 |
|
|
$ |
(702 |
) |
|
$ |
(2,740 |
) |
|
$ |
(8,287 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
12
9. Marketable Securities
Effective January 1, 2008, the Company adopted FASB Statement No. 157, Fair Value Measurements
(SFAS 157), which defines fair value, establishes a framework for measuring fair value under
generally accepted accounting principles, and expands disclosures about fair value measurements. On
February 6, 2008, the FASB deferred the effective date of SFAS 157 for all nonfinancial assets and
nonfinancial liabilities, except those that are recognized or disclosed at fair value in the
financial statements on a recurring basis. These nonfinancial items include assets and liabilities
such as reporting units measured at fair value in a goodwill impairment test and nonfinancial
assets acquired and liabilities assumed in a business combination. The Company measures certain
assets at fair value and thus there was no impact on the Companys consolidated financial statement
at the adoption of SFAS 157. SFAS 157 requires disclosure that establishes a framework for
measuring fair value and expands disclosure about fair value measurements. The statement requires
fair value measurement be classified and disclosed in one of the following three categories:
Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement
date for assets or liabilities.
Level 2: Observable prices that are based on inputs not quoted on active markets, but
corroborated by market data.
Level 3: Unobservable inputs are used when little or no market data is available.
The Company measures available-for-sale securities at fair value on a recurring basis. All of
the Companys assets measured at fair value on a recurring basis subject to the disclosure
requirements of SFAS 157 as of June 30, 2009 are categorized as Level 1. The Company recorded an
unrealized loss of $27,000 and $142,000 in the three months ended June 30, 2009 and 2008,
respectively, and an unrealized loss of $299,000 and $116,000 in the six months ended June 30, 2009
and 2008, respectively. The unrealized loss is included as a component of other comprehensive loss
within stockholders equity.
Effective January 1, 2009, the Company implemented SFAS 157 for nonfinancial assets and
liabilities that are remeasured at fair value on a non-recurring basis. The adoption of SFAS 157
for nonfinancial assets and liabilities that are remeasured at fair value on a non-recurring basis
did not have a material impact on the financial position or results of operations; however, it
could have an impact in future periods. In addition, the Company may have additional disclosure
requirements in the event they complete an acquisition or incur asset impairment in future periods.
The following table summarizes the fair value of the Companys available-for-sale securities
held in its marketable securities investment portfolio, recorded as short-term or long-term
marketable securities as of June 30, 2009 and December 31, 2008:
13
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
|
|
|
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Estimated |
|
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Fair Value |
|
|
|
(In thousands) |
|
June 30, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commercial paper with initial maturities of 90 days or less |
|
$ |
2,267 |
|
|
|
|
|
|
|
|
|
|
$ |
2,267 |
|
Corporate notes with initial maturities of greater than 90 days |
|
|
5,351 |
|
|
|
42 |
|
|
|
|
|
|
|
5,393 |
|
Securities of government-sponsored entities |
|
|
17,306 |
|
|
|
134 |
|
|
|
|
|
|
|
17,440 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term marketable securities |
|
|
24,924 |
|
|
|
176 |
|
|
|
|
|
|
|
25,100 |
|
Corporate notes |
|
|
300 |
|
|
|
|
|
|
|
|
|
|
|
300 |
|
Securities of government-sponsored entities |
|
|
18,930 |
|
|
|
121 |
|
|
|
|
|
|
|
19,051 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total marketable securities at June 30 2009 |
|
$ |
44,154 |
|
|
$ |
297 |
|
|
$ |
|
|
|
$ |
44,451 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commercial paper with initial maturities of 90 days or less |
|
$ |
1,213 |
|
|
|
|
|
|
|
(2 |
) |
|
$ |
1,211 |
|
Corporate notes with initial maturities of greater than 90 days |
|
|
4,283 |
|
|
|
4 |
|
|
|
(6 |
) |
|
|
4,281 |
|
Securities of government-sponsored entities |
|
|
40,054 |
|
|
|
197 |
|
|
|
(5 |
) |
|
|
40,246 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term marketable securities |
|
|
45,550 |
|
|
|
201 |
|
|
|
(13 |
) |
|
|
45,738 |
|
Corporate notes |
|
|
4,467 |
|
|
|
15 |
|
|
|
(52 |
) |
|
|
4,430 |
|
Securities of government-sponsored entities |
|
|
40,495 |
|
|
|
380 |
|
|
|
|
|
|
|
40,875 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total marketable securities at December 31, 2008 |
|
$ |
90,512 |
|
|
$ |
596 |
|
|
$ |
(65 |
) |
|
$ |
91,043 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of June 30, 2009, the stated maturities of our
marketable securities are $25.1 million
within one year and $44.5 million within one to three years. These investments are recorded on the
balance sheet at fair market value with unrealized gains or losses reported as a separate component
of accumulated other comprehensive income.
As of June 30, 2009 we had no significant investment positions that were in an unrealized loss
position. We review our investments to identify and evaluate investments that have an indication of
possible other-than-temporary impairment. Factors considered in determining whether a loss is
other-than-temporary include the length of time and extent to which fair value has been less than
the cost basis, the financial condition and near-term prospects of the investee, and our intent and
ability to hold the investment for a period of time sufficient to allow for any anticipated
recovery in market value. We maintain an investment portfolio of various holdings, types and
maturities. We do not use derivative financial instruments. We place our cash investments in
instruments that meet high credit quality standards, as specified in our investment policy
guidelines. These guidelines also limit the amount of credit exposure to any one issue, issuer or
type of instrument.
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. Realized gains and losses
during the periods presented were immaterial. The cost of securities sold is based on the specific
identification method. Interest and dividends on securities classified as available-for-sale are
included in investment income.
10. Income Taxes
The Company accounts for income taxes in accordance with FAS No. 109, Accounting for Income
Taxes. Deferred income tax assets and liabilities are recognized for temporary differences between
financial statement and income tax carrying values using tax rates in effect for the years such
differences are expected to reverse. At December 31, 2008, the Company had net deferred tax assets
of $85.4 million primarily attributable to net operating loss carry-overs, research and exploration
credits, original issue discount, stock-based compensation expense and fixed assets. Due to
uncertainties surrounding the Companys ability to generate future taxable income to realize such
deferred income tax assets, a full valuation allowance has been established. With immaterial
exception, the Company continues to maintain a full valuation allowance against its deferred tax
assets as of June 30, 2009.
On July 13, 2006, the FASB issued Financial Interpretation No. 48, Accounting for Uncertainty
in Income Taxes (FIN 48). Under FIN 48, the impact of an uncertain income tax position on the
income tax return must be recognized at the largest amount that is more-likely-than-not to be
sustained upon audit by the relevant tax authority. An uncertain income tax position will not be
recognized if it has less than a 50% likelihood of being sustained. Additionally, FIN 48 provides
guidance on de-recognition, classification, interest and penalties, accounting in interim periods,
disclosure and transition. The Company adopted the provisions of FIN 48 on January 1, 2007, its
effective date. There have been no changes in unrecognized tax benefits or other items pertaining
to FIN 48 since December 31, 2008 and as such, disclosures included in the Companys 2008 Annual
Report on Form 10-K continue to be relevant for the period ended June 30, 2009.
14
11. Stock-Based Compensation
For purposes of calculating the stock-based compensation under FAS 123(R), Share Based
Payments, the Company estimates the fair value of stock options granted to employees and shares
issued under the Employee Stock Purchase Plan, or ESPP Plan, using a Black-Scholes option-pricing
model. The assumptions used to estimate the fair value of stock awards granted in the three and six
months ended June 30, 2009 and 2008 are as follows:
|
|
|
|
|
|
|
Three and Six Months |
|
Three and Six Months |
|
|
Ended June 30, 2009 |
|
Ended June 30, 2008 |
|
|
|
|
|
Stock Options |
|
|
|
|
Volatility |
|
45% to 48% |
|
42% |
Expected term (years) |
|
3.0 to 4.9 |
|
2.5 to 4.5 |
Risk free interest rate |
|
1.36% to 1.7% |
|
2.46% to 3.41% |
Expected dividend yield |
|
0.0% |
|
0.0% |
|
|
|
|
|
ESPP |
|
|
|
|
Volatility |
|
40% to 65% |
|
42% to 50% |
Expected term (years) |
|
0.5 to 2 |
|
0.5 |
Risk free interest rate |
|
0.92% to 4.86% |
|
3.03% to 4.01% |
Expected dividend yield |
|
0.0% |
|
0.0% |
The compensation cost that has been included in the statement of operations for all stock-based
compensation arrangements was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
(in thousands, except per share amounts) |
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
Sales, marketing and administrative expense |
|
$ |
5,243 |
|
|
$ |
4,538 |
|
|
$ |
10,484 |
|
|
$ |
9,042 |
|
Research and development expense |
|
|
1,074 |
|
|
|
610 |
|
|
|
2,515 |
|
|
|
1,256 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation expense |
|
$ |
6,317 |
|
|
$ |
5,148 |
|
|
$ |
12,999 |
|
|
$ |
10,298 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect on basic net income (loss) per share |
|
$ |
(0.17 |
) |
|
$ |
(0.14 |
) |
|
$ |
(0.35 |
) |
|
$ |
(0.29 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect on diluted net income (loss) per share |
|
$ |
(0.16 |
) |
|
$ |
(0.14 |
) |
|
$ |
(0.35 |
) |
|
$ |
(0.29 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation for stock options and restricted stock units is recognized and
amortized on an accelerated basis in accordance with Financial Accounting Standards Board
Interpretation No. 28, Accounting for Stock Appreciation Rights and Other Variable Stock Option
Award Plans.
Restricted Stock Units
During the six months ended June 30, 2009, approximately 186,000 time-vested restricted stock
units, or RSUs, were granted at a grant date fair value of $34.77 per share. For the three and six
months ended June 30, 2009, the Company recorded $0.7 million and $1.3 million, respectively, of
stock-based compensation expense related to RSUs. During the three and six months ended June 30,
2008, there were no RSUs granted.
12. Building Lease
On November 6, 2007, the Company entered into a 15-year lease agreement for the purpose of
relocating the Companys corporate headquarters to an approximately 140,000 square foot
two-building campus style complex in San Diego. Rental payments consist of base rent that escalates
at an annual rate of three percent over the 15-year period of the lease, plus building related
expenses paid to the landlord. In addition, through options to acquire additional space in the
project and to require the construction of an additional building on the campus, the agreement
provides for facility expansion rights to an aggregate of more than 300,000 leased square feet. In
connection with the lease, the Company issued a $3.1 million irrevocable transferable letter of
credit. Relocation to the new facility was completed during August 2008.
The Company expects to sublease its previous corporate headquarters through August 2012, the
date on which the related lease agreement expires; however, the Company also expects that the space
will remain vacant for approximately an additional 14 months from June 30, 2009 with no associated
sublease income during that time. Upon moving the final phase of shareowners (employees) and
operations to the new headquarters during August of 2008, the Company recorded a loss equal to the
estimated present value of expected net future cash flows in the amount of $4.8 million in selling
general and administrative expenses. The Company has assumed, in performing the calculation of the
loss, that the facility would remain vacant for approximately 24 months from the cease
15
use date in August 2008 given the current market conditions. As of the date of this filing,
the Company has not yet entered into a sublease agreement and cannot be assured that a sublease, if
any, will provide the anticipated sublease income used to calculate the above charge taken in the
year ended December 31, 2008.
At December 31, 2008, the Company had a liability for approximately $4.0 million related to
lease termination costs in connection with vacating the Companys former corporate headquarters.
During the six months ended June 30, 2009, this liability was reduced by approximately $1.0 million
due to monthly cash rental payments.
13. Impact of Recently Issued Accounting Standards
Recently Adopted Accounting Standards
Effective January 1, 2009, the Company implemented Statement of Financial Accounting Standards
(SFAS) No. 141(R), Business Combinations (FAS 141R). This standard requires an acquiring company to
measure all assets acquired and liabilities assumed, including contingent considerations and all
contractual contingencies, at fair value as of the acquisition date. In addition, an acquiring
company is required to capitalize in-process research and development and either amortize it over
the life of the product, or write it off if the project is abandoned or impaired. FAS 141R amended
FAS 109, and FIN 48. Previously, FAS 109 and FIN 48, respectively, generally required
post-acquisition adjustments related to business combination deferred tax asset valuation
allowances and liabilities for uncertain tax positions to be recorded as an increase or decrease to
goodwill. FAS 141R does not permit this accounting and, generally, requires any such changes to be
recorded in current period income tax expense. Thus, all changes to valuation allowances and
liabilities for uncertain tax positions established in acquisition accounting, whether the business
combination was accounted for under FAS 141 or FAS 141R, will be recognized in current period
income tax expense. The Company expects FAS 141R will have an impact on the consolidated financial
statements, but the nature and magnitude of the specific effects will depend upon the nature, terms
and size of the acquisitions consummated after the effective date of January 1, 2009.
Effective January 1, 2009, the Company adopted FSP FAS 141(R)-1 which amends FAS 141R for the
accounting treatment afforded preacquisition contingencies. Under the FSP, an acquirer is required
to recognize at fair value an asset acquired or liability assumed in a business combination that
arises from a contingency if the acquisition-date fair value of the liability can be determined
during the measurement period. If the acquisition-date fair value cannot be determined, the
acquirer applies the recognition criteria in FAS Statement No. 5, and Interpretation 14, to
determine whether the contingency should be recognized as of the acquisition date or after the
acquisition date.
Effective January 1, 2009, the Company implemented SFAS No. 160, Noncontrolling Interests in
Consolidated Financial Statements, an amendment of Accounting Research Bulletin No. 51 (FAS 160).
This standard addresses the accounting and reporting standards for ownership interests in
subsidiaries held by parties other than the parent, the amount of consolidated net income
attributable to the parent and to the noncontrolling interest, changes in a parents ownership
interest, and the valuation of retained noncontrolling equity investments when a subsidiary is
deconsolidated. FAS 160 also establishes disclosure requirements that clearly identify and
distinguish between the interests of the parent and the interests of the noncontrolling owners. The
Company expects FAS 160 will have an impact on the consolidated financial statements, but the
nature and magnitude of the specific effects will depend upon the nature, terms and size of the
investments made after the effective date of January 1, 2009.
Effective January 1, 2009, the Company adopted FSP No. 142-3, Determination of the Useful Life
of Intangible Assets (FSP 142-3), which amends the factors that should be considered in developing
renewal or extension assumptions used to determine the useful life of a recognized intangible asset
under SFAS 142. This pronouncement requires enhanced disclosures concerning a companys treatment
of costs incurred to renew or extend the term of a recognized intangible asset. The adoption of FSP
142-3 did not have a material impact on our consolidated financial position, results of operations
or cash flows.
Effective April 1, 2009, the Company adopted FSP No. 157-3, Determining the Fair Value of a
Financial Asset When the Market for That Asset Is Not Active (FSP 157-3). FSP 157-3 clarifies the
application of SFAS No. 157 in a market that is not active, and is effective as of the issue date,
including application to prior periods for which financial statements have not been issued. The
adoption of FSP 157-3 did not have a material impact on our consolidated financial position,
results of operations or cash flows.
Effective April 1, 2009, the Company adopted FASB Staff Position FAS 157-4, Determining Fair
Value When the Volume and Level of Activity for the Asset and Liability Have Significantly
Decreased and Identifying Transaction that are not Orderly (FSP FAS 157-4). This Staff Position
provides guidelines for making fair value measurements more consistent with the principles
presented in SFAS 157. In addition, FSP FAS 157-4 provides additional authoritative guidance in
determining whether a market is active or inactive, and whether a transaction is distressed, is
applicable to all assets and liabilities (financial and nonfinancial) and requires
enhanced disclosures. The adoption of FSP 157-4 did not have a material impact on our
consolidated financial position, results of operations or cash flows.
16
Effective April 1, 2009, the Company adopted FASB Staff Position FAS 115-2, FAS 124-2, and
EITF 99-20-2, Recognition and Presentation of Other-Than-Temporary Impairments, (FSP FAS 115-2, FAS
124-2, and EITF 99-20-2); and FSP FAS 115-2, FAS 124-2, and EITF 99-20-2 provides additional
guidance to provide greater clarity about the credit and noncredit component of an
other-than-temporary impairment event and to more effectively communicate when an
other-than-temporary impairment event has occurred. This FSP applies to debt securities. The
adoption of these pronouncements did not have a material impact on our consolidated financial
position, results of operations or cash flows.
Effective April 1, 2009, the Company adopted FASB Staff Position FAS 107-1 and APB 28-1,
Interim Disclosures about Fair Value of Financial Instruments, (FSP FAS 107-1 and APB 28-1). FSP
FAS 107-1 and APB 28-1, amends FASB Statement No. 107, Disclosures about Fair Value of Financial
Instruments, to require disclosures about fair value of financial instruments in interim as well as
in annual financial statements. This FSP also amends APB Opinion No. 28, Interim Financial
Reporting, to require those disclosures in all interim financial statements. The adoption of these
pronouncements did not have a material impact on our consolidated financial position, results of
operations or cash flows.
In May 2009, the FASB issued SFAS No. 165, Subsequent Events (SFAS 165). SFAS 165 is intended
to establish general standards of accounting for and disclosure of events that occur after the
balance sheet date but before the financial statements are issued or are available to be issued. It
requires the disclosure of the date through which an entity has evaluated subsequent events and the
basis for that date. The effective date for SFAS 165 is for interim or annual financial periods
ending after June 15, 2009. The Company adopted the provisions of SFAS 165 as of June 30, 2009. The
Company evaluated subsequent events after the balance sheet date of June 30, 2009 through August 6,
2009, the date of issuance of the consolidated financial statements. The adoption of SFAS 165 had
no impact on the Companys consolidated financial statements as management already followed a
similar approach prior to the adoption of this standard.
Recently Issued Accounting Standards
In June 2009, the FASB issued SFAS No. 167,
The Hierarchy of Generally Accepted Accounting
Principles (FAS 167). This statement amends the consolidation guidance that applies to variable
interest entities and significantly affects the overall consolidation analysis under Interpretation
46(R). The statement is effective for years beginning January 1, 2010. The Company is currently
evaluating the impact the adoption will have on its consolidated financial statements.
In June 2009, the FASB issued Statement No. 168, The FASB Accounting Standards Codification
and the Hierarchy of Generally Accepted Accounting Principles (SFAS 168). SFAS 168 will become the
single source of authoritative nongovernmental U.S. GAAP, superseding existing FASB, American
Institute of Certified Public Accountants (AICPA), Emerging Issues Task Force (EITF), and related
accounting literature. SFAS 168 reorganizes the thousands of GAAP pronouncements into roughly 90
accounting topics and displays them using a consistent structure. Also included is relevant
Securities and Exchange Commission guidance organized using the same topical structure in separate
sections. SFAS 168 will be effective for financial statements issued for reporting periods that
end after September 15, 2009. This will have an impact on the Companys financial statements since
all future references to authoritative accounting literature will be in accordance with SFAS 168.
14. Legal Proceedings
Medtronic Sofamor Danek USA, Inc. Litigation
As previously disclosed, in August 2008, Medtronic Sofamor Danek USA, Inc. and its related
entities (Medtronic) filed suit against NuVasive in the United States District Court for the
Southern District of California (Medtronic Litigation), alleging that certain of NuVasives
products infringe, or contribute to the infringement of, twelve U.S. patents assigned or licensed
to Medtronic (three of the patents have since been removed from the case, leaving nine patents
remaining). On March 9, 2009, NuVasive filed inter partes reexamination requests with the U.S.
Patent and Trademark Office, requesting that six of the nine patents in suit be reexamined (those
relating to anterior cervical plates). Also on March 9, 2009, NuVasive filed a motion to stay
requesting that the Court stay the litigation proceedings on these six patents pending the outcome
of any reexamination proceeding. On April 28, 2009, NuVasive amended its counterclaim to assert
NuVasives U.S. Patent No. 7,207,949 against Medtronic, which NuVasive contends is being infringed
by Medtronics NIM-Eclipse System, Quadrant products, and DLIF surgical technique. The Medtronic
Litigation is in the early stages of the proceedings. An order establishing a schedule for the case
is expected in the near term. NuVasive believes Medtronics claims lack merit and intends to defend
the case vigorously. As of June 30, 2009, the probability of an outcome cannot be
17
reasonably determined, nor can the Company reasonably estimate a potential loss, therefore, in
accordance with FAS 5, the Company has not recorded an accrual related to this litigation.
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
Forward-Looking Statements May Prove Inaccurate
You should read the following discussion of our financial condition and results of operations
in conjunction with the unaudited consolidated financial statements and the notes to those
statements included in this report. This discussion may contain forward-looking statements that
involve risks and uncertainties. Our actual results may differ materially from those anticipated in
these forward-looking statements as a result of certain factors, such
as those set forth under heading Risk Factors, and
elsewhere in this
report, and similar discussions in our other Securities and Exchange Commission filings, including
our Annual Report on Form 10-K for the year ending December 31, 2008. We do not intend to update
these forward looking statements to reflect future events or circumstances.
Overview
We are a medical device company focused on the design, development and marketing of products
for the surgical treatment of spine disorders. Our product portfolio is focused primarily on the
$4.6 billion U.S. spine implant market. Additionally, we have expanded into the $1.5 billion global
biologics market, the $1.5 billion international spine implant market, and are developing products for the
emerging motion preservation market.
Our principal product offering is based on our Maximum Access Surgery, or MAS® platform. The
MAS platform combines four categories of products that collectively minimize soft tissue disruption
during spine surgery with maximum visualization and safe, easy reproducibility for the surgeon:
NeuroVision®, a proprietary software-driven nerve avoidance system; MaXcess®, a unique split-blade
retractor system; a wide variety of specialized implants; and several biologic fusion enhancers.
MAS significantly reduces surgery time and returns patients to activities of daily living much
faster than conventional approaches. Having redefined spine surgery with the MAS platforms lateral
approach, known as eXtreme Lateral Interbody Fusion, or XLIF®, we have built an entire spine
franchise. With over 50 products today that span lumbar, thoracic and cervical applications, we
will continue to expand and evolve our offering predicated on our R&D focus and dedication to
outstanding service levels supported by our culture of Absolute Responsiveness®.
In recent years we have significantly expanded our product offering relating to procedures in
the cervical spine as well as in the area of biologics. Our cervical product offering now provides
a full set of solutions for cervical fusion surgery, including both allograft and CoRoent®
implants, as well as cervical plating and posterior fixation products. We enhanced our biologic
offering in 2007 with the acquisition of rights to FormaGraft®, a collagen synthetic product used
to aid the fusion process. This offering expanded in 2008 with the acquisition of Osteocel® from
Osiris Therapeutics, an allograft cellular matrix containing viable mesenchymal stem cells, or
MSCs, to aid in spinal fusion. In 2009, we further developed NuVasives biologic portfolio via an
investment into Progentix, a company with a novel Osteoinductive synthetic that has properties
similar to BMP as well as a proprietary manufacturing process that creates superior microstructure
using calcium phosphate.
We also offer a suite of traditional spine surgery products, including certain products in our
CoRoent suite of implants, a titanium surgical mesh system, a line of precision-machined cervical
and lumbar allograft implants, and related instrumentation. Our
Triad® and Extensure®
lines of bone allograft, in our patented saline packaging, is human bone that has been processed
and precision shaped for transplant. We also offer fusion fixation products that offer unique
technological benefits such as our Helix® and Gradient Plustm cervical plate
systems and SpheRx pedicle screw system.
We have an active product development pipeline focused on expanding our current fusion product
platform as well as products designed to preserve spinal motion. In May 2009, we acquired
Cervitech, a company focused on clinical approval of the PCM cervical disc system, a motion
preserving total disc replacement device. Enrollment of the pivotal trial is complete and the trial
protocol requires a two year follow up period on all patients before submitting to the FDA for
potential approval. In August 2008, we completed the enrollment of our pivotal clinical trial for
NeoDisc®, our cervical disc replacement device. The trial protocol requires a two-year follow up
period on all patients before submitting to the FDA for potential approval.
Recent Developments
In January 2009, we purchased forty percent (40%) of the capital stock of Progentix
Orthobiology, B.V., a company organized under the laws of the Netherlands (Progentix), from
existing shareholders for $10 million in cash (the Initial Investment). Progentix has as its
objective the development and exploitation of knowledge and products in the field of bone defects
and the recovery of bone
tissue in general. Progentix wishes to further extend the existing knowledge and patent
position in the field of Osteoinductive Bone Graft Material Technology.
18
In May 2009, we purchased Cervitech® Inc., (Cervitech), a New Jersey based company
focused on clinical approval of the PCM® cervical disc system, a motion preserving total
disc replacement device, for an initial purchase price of approximately $48 million, consisting of
cash totaling approximately $24 million and the issuance of 638,261 shares of NuVasive common stock to certain
stockholders of Cervitech. This strategic acquisition allows us the potential to accelerate our
entry into the growing mechanical cervical disc replacement market. Currently, the PCM
investigational device is in an FDA-approved clinical trial in the United States and two year
follow up is scheduled to be completed in the fourth quarter of 2009. We anticipate submitting for
FDA approval in the first quarter of 2010. The potential approval will further strengthen our
cervical product offering and will enable us to continue our trend of increasing our market share.
From
inception through June 30, 2009, we had an accumulated deficit of approximately $197.0
million.
Revenues. The majority of our revenues are derived from the sale of disposables and implants
and we expect this trend to continue in the near term. We loan our NeuroVision systems and surgical
instrument sets at no cost to surgeons and hospitals that purchase disposables and implants for use
in individual procedures; there are no minimum purchase requirements of disposables and implants
related to these loaned surgical instruments. In addition, we place NeuroVision, MaXcess and other
MAS or cervical surgical instrument sets with hospitals for an extended period at no up-front cost
to them provided they commit to minimum monthly purchases of disposables and implants. Our implants
and disposables are currently sold and shipped from our primary distribution and warehousing
operations facility located in Memphis, Tennessee. We recognize revenue for disposables or implants
used upon receiving a purchase order from the hospital indicating product use or implantation. In
addition, we sell a small number of MAS instrument sets, MaXcess devices, and NeuroVision systems.
To date, we have derived less than 5% of our total revenues from these sales.
Sales and Marketing. Through June 30, 2009, substantially all of our operations are located in
the United States and substantially all of our sales to date have been generated in the United
States. We sell our products through a sales force comprised of exclusive independent sales
agencies and our own directly employed sales professionals; both selling only NuVasive spine
surgery products. Our sales force provides a delivery and consultative service to our surgeon and
hospital customers and is compensated based on sales and product placements in their territories.
Sales force commissions are reflected in our statement of operations in the sales, marketing and
administrative expense line. We expect to continue to expand our distribution channel. Beginning
late in 2007 and continuing today, we are continuing our expansion in international sales efforts
with the initial focus on European markets. We expect our international sales force to be made up
of a combination of distributors and direct sales personnel.
Critical Accounting Policies
Our discussion and analysis of our financial condition and results of operations is based upon
our unaudited condensed consolidated financial statements, which have been prepared in accordance
with accounting principles generally accepted in the United States (GAAP). The preparation of these
financial statements requires us to make estimates and judgments that affect the reported amounts
of assets, liabilities, revenues and expenses. On an ongoing basis, we evaluate our estimates
including those related to bad debts, inventories, valuation of goodwill, intangibles and other
long-term assets, income taxes, and stock-based compensation. We base our estimates on historical
experience and on various other assumptions we believe to be reasonable under the circumstances,
the results of which form the basis for making judgments about the carrying values of assets and
liabilities not readily apparent from other sources. Actual results may differ from these
estimates. Our critical accounting policies and estimates are discussed in our annual report on
Form 10-K for the fiscal year ended December 31, 2008 and there have been no material changes
during the three and six months ended June 30, 2009.
New accounting requirements.
On January 1, 2009,
we adopted Statement of Financial Accounting Standards (SFAS) No. 141R,
Business Combinations (FAS 141R). This standard requires an acquiring company to measure all
assets acquired and liabilities assumed, including contingent considerations and all contractual
contingencies, at fair value as of the acquisition date. In addition, an acquiring company is
required to capitalize in-process research and development and either amortize it over the life of
the product, or write it off if the project is abandoned or impaired. FAS 141R amended FAS 109,
and FIN 48. Previously, FAS 109 and FIN 48, respectively, generally required post-acquisition
adjustments related to business combination deferred tax asset valuation allowances and liabilities
for uncertain tax positions to be recorded as an increase or decrease to goodwill. FAS 141R does
not permit this accounting and, generally, requires any such changes to be recorded in current
period income tax expense. Thus, all changes to valuation allowances and liabilities for uncertain
tax positions established in acquisition accounting, whether the business combination was accounted
for under FAS 141 or FAS 141R, will be recognized in current period income tax expense. The
Company expects FAS No. 141R will
19
have an impact on the consolidated financial statements, but the nature and magnitude of the
specific effects will depend upon the nature, terms and size of the acquisitions consummated after
the effective date of January 1, 2009.
On January 1, 2009, we adopted January 1, 2009, the Company implemented SFAS No. 160,
Noncontrolling Interests in Consolidated Financial Statements, an amendment of Accounting Research
Bulletin No. 51 (FAS 160). This standard addresses the accounting and reporting standards for
ownership interests in subsidiaries held by parties other than the parent, the amount of
consolidated net income attributable to the parent and to the noncontrolling interest, changes in a
parents ownership interest, and the valuation of retained noncontrolling equity investments when a
subsidiary is deconsolidated. FAS 160 also establishes disclosure requirements that clearly
identify and distinguish between the interests of the parent and the interests of the
noncontrolling owners. The Company expects FAS 160 will have an impact on the consolidated
financial statements, but the nature and magnitude of the specific effects will depend upon the
nature, terms and size of the investments made after the effective date of January 1, 2009. We
will apply the provisions of SFAS No. 160 when we have such noncontrolling interests.
On January 1, 2009, we adopted FSP FAS 142-3, Determination of the Useful Life of Intangible
Assets. FSP FAS 142-3 amends the factors that should be considered in developing a renewal or
extension assumptions used for purposes of determining the useful life of a recognized intangible
asset under Statement of Financial Accounting Standards No. 142, Goodwill and Other Intangible
Assets (SFAS 142). FSP FAS 142-3 is intended to improve the consistency between the useful life
of a recognized intangible asset under SFAS No. 142 and the period of expected cash flows used to
measure the fair value of the asset under SFAS 141R and other U.S. generally accepted accounting principles. The
application of FSP FAS 142-3 did not have a material impact on our consolidated financial position,
results of operations or cash flows.
Results of Operations
Revenue
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
(dollars in thousands) |
|
2009 |
|
2008 |
|
$ Change |
|
% Change |
Three months ended |
|
$ |
88,481 |
|
|
$ |
57,417 |
|
|
$ |
31,064 |
|
|
|
54.1 |
% |
Six months ended |
|
$ |
168,490 |
|
|
$ |
108,601 |
|
|
$ |
59,889 |
|
|
|
55.1 |
% |
Revenues have increased over time due primarily to continued market acceptance of our products
within our MAS® platform, including
NeuroVision® and MaXcess
® disposables, our Biologics offering,
and our specialized implants such as our
XLP® lateral plate, SpheRx®
pedicle screw
systems, and CoRoent® suite of products. The continued adoption of minimally invasive procedures
for spine has led to the continued expansion of our innovative lateral procedure known as eXtreme
Lateral Interbody Fusion, or XLIF®, in which surgeons access the spine for a fusion procedure from
the side of the patients body, rather than from the front or back. The execution of our strategy
of expanding our product offering for the lumbar region and addressing broader indications further
up the spine in the thoracic and cervical regions has contributed to strong revenue growth. We
expect revenue to continue to increase, which can be attributed to the continued adoption of our
XLIF procedure and deeper penetration into existing accounts as our sales force executes on the
strategy of selling the full mix of our products.
Cost of Goods Sold
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
(dollars in thousands) |
|
2009 |
|
2008 |
|
$ Change |
|
% Change |
Three months ended |
|
$ |
16,710 |
|
|
$ |
9,571 |
|
|
$ |
7,139 |
|
|
|
74.6 |
% |
% of revenue |
|
|
18.9% |
|
|
|
16.7% |
|
|
|
|
|
|
|
|
|
Six months ended |
|
$ |
31,484 |
|
|
$ |
18,666 |
|
|
$ |
12,818 |
|
|
|
68.7 |
% |
% of revenue |
|
|
18.7% |
|
|
|
17.2% |
|
|
|
|
|
|
|
|
|
Cost of goods sold consists of purchased goods and overhead costs, including depreciation
expense for instruments.
The increase in cost of goods sold in total dollars in the three and six months ended June 30,
2009 compared to the same period in 2008 resulted primarily from (i) increased direct costs of $2.4
million and $7.5 million, respectively, primarily to support revenue growth; (ii) increased
Osteocel product costs of $3.1 million and $5.0 million, respectively; and (iii) increased depreciation expense of $1.3 million and $2.5
million, respectively, incurred on the increased amount of surgical instrument sets we hold for use
in surgeries. We expect cost of goods sold, as a percentage of revenue, to remain at these levels
for the remainder of 2009.
20
Operating Expenses
Sales, Marketing and Administrative.
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
(dollars in thousands) |
|
2009 |
|
2008 |
|
$ Change |
|
% Change |
Three months ended |
|
$58,149 |
|
$42,099 |
|
$16,050 |
|
38.1% |
% of revenue |
|
65.7% |
|
73.3% |
|
|
|
|
Six months ended |
|
$116,630 |
|
$81,416 |
|
$35,214 |
|
43.3% |
% of revenue |
|
69.2% |
|
75.0% |
|
|
|
|
Sales, marketing and administrative expenses consist primarily of compensation, commission and
training costs for personnel engaged in sales, marketing and customer support functions;
distributor commissions; surgeon training costs; shareowner (employee) related expenses for our
administrative functions; third party professional service fees; amortization of acquired
intangible assets; and facilities and insurance expenses.
The increases in sales, marketing and administrative expenses principally result from growth
in our revenue and the overall growth of the Company, including expenses that fluctuate with sales
and expenses associated with investments in our infrastructure and headcount growth.
Increases in costs based on revenue, such as sales force compensation and other direct costs
related to the sales force, royalty expense, and shipping costs were $6.2 million and $13.5 million
for the three and six months ended June 30, 2009, respectively, compared to the same periods in
2008. The increases are consistent with our increased revenue growth of approximately 55% in the
first half of 2009 as compared to the same period in 2008. Total costs related to our sales force,
as a percent of revenue, decreased to 29.8% from 32.3% for the three months ended June 30, 2009
compared to the same period in 2008. The decrease in costs as a percentage of revenue was primarily
attributable to the increased revenues.
We also experienced increased costs as a result of overall Company growth and headcount
additions in our marketing and administrative support functions. Marketing and administrative
compensation and personnel costs increased $4.8 million and $9.3 million for the three and six
months ended June 30, 2009, respectively, compared to the same periods in 2008 and facility,
equipment and computer expenses increased by $1.3 million and $3.6 million for the three and six
months ended June 30, 2009, respectively, compared to the same periods in 2008, primarily as a
result of continued headcount growth and facility build outs to support the increasing number of
shareowners (employees).
During the first quarter of 2009, we adopted FAS 141R, Business Combinations, which requires
that acquisition related costs be expensed in the period in which the costs are incurred. This
differs from previous accounting treatment in that the acquisition related expenses were included as part of
the purchase price of the acquired company. We incurred approximately $0.6 million and $2.4 million
in acquisition related costs in connection with our investment in Progentix and acquisition of
Cervitech in the three and six months ended June 30, 2009, respectively, with no comparable expense
during the same periods in 2008.
We incurred other significant expenses in 2008 that are designed to increase the scalability
of our business over time. We completed the implementation of our new enterprise resource planning,
or ERP, software system in 2008. We incurred a total of $10.9 million in costs related to the ERP
project through June 2008, which has been capitalized. We are amortizing the capitalized costs over
a 7-year period beginning in July 2008.
In addition, we entered into a lease of a two-building campus-style headquarters complex in
November 2007 to accommodate our continued growth. The relocation process to the new facility was
achieved in stages that began in March 2008 and completed in August 2008. As a result, we began to
incur increased facility costs beginning in March 2008.
On a long-term basis, as a percentage of revenue, we expect total sales, marketing and
administrative costs to continue to decrease over time as we continue to see the synergies of
investments we have made.
21
Research and Development.
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
(dollars in thousands) |
|
2009 |
|
2008 |
|
$ Change |
|
% Change |
Three months ended |
|
$9,200 |
|
$6,426 |
|
$2,774 |
|
43.2% |
% of revenue |
|
10.4% |
|
11.2% |
|
|
|
|
Six months ended |
|
$19,393 |
|
$13,402 |
|
$5,991 |
|
44.7% |
% of revenue |
|
11.5% |
|
12.3% |
|
|
|
|
Research and development expense consists primarily of product research and development,
clinical trial costs, regulatory and clinical functions, and shareowner (employee) related
expenses.
The increase in research and development costs in the periods presented are primarily due to
expenses related to litigation support costs of $1.0 million and $2.6 million incurred during the
three and six months ended June 30, 2009, respectively, with no comparable expenses during the same
periods in 2008. Compensation and other shareowner related expenses increased $1.1 million and $2.6
million, including an increase in stock-based compensation of $0.5 million and $1.3 million, for
the three and six months ended June 30, 2009, respectively, compared to the same periods in 2008,
primarily due to increased headcount to support our product development and enhancement efforts. We
expect research and development costs to continue to increase in absolute dollars for the
foreseeable future in support of our ongoing development activities and planned clinical trial
activities.
In-Process Research and Development.
In 2008, we recorded in-process research and development (IPR&D) charges of $4.2 million
related to the acquisition of pedicle screw technology in the first quarter of 2008. As of the date
of the acquisition, the projects associated with the IPR&D efforts had not yet reached
technological feasibility and the research and development in-process had no alternative future
uses. Accordingly, the amount was charged to expense on the acquisition date in accordance with FAS
141, Business Combinations.
During the first quarter 2009, we adopted FAS 141(R), Business Combinations (FAS 141R), which
is applied prospectively for all new business acquisitions entered into after January 1, 2009, and
which requires that IPR&D acquired is no longer charged to expense on the acquisition date, but
rather recorded as an asset on the balance sheet. Amounts recorded as IPR&D beginning after January
1, 2009, will begin being amortized upon first sales of the product over the estimated useful life
of the technology. As of June 30, 2009, we have recorded approximately $46.0 million on our balance
sheet related to IPR&D in conjunction with the Progentix Investment and acquisition of Cervitech,
as described above. In accordance with FAS 141R, as the technology has not yet been approved, the
amortization of the acquired IPR&D has not begun. In addition, in accordance with FAS141R, there
were no charges to the statement of operations during the first six months of 2009.
Interest and Other Income, Net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
(dollars in thousands) |
|
2009 |
|
2008 |
|
$ Change |
|
% Change |
Three months ended: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
$ |
383 |
|
|
$ |
1,777 |
|
|
|
|
|
|
|
|
|
Other income (expense), net |
|
|
(433 |
) |
|
|
70 |
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
(2,060 |
) |
|
|
(1,663 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total interest and other income (expense), net |
|
$ |
(2,110 |
) |
|
$ |
184 |
|
|
$ |
(2,294 |
) |
|
|
(1,246.7 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of revenue |
|
|
(2.4)% |
|
|
|
0.3% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six months ended: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
$ |
1,115 |
|
|
$ |
2,913 |
|
|
|
|
|
|
|
|
|
Other income (expense), net |
|
|
(488 |
) |
|
|
94 |
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
(3,830 |
) |
|
|
(2,097 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total interest and other income (expense), net |
|
$ |
(3,203 |
) |
|
$ |
910 |
|
|
$ |
(4,113 |
) |
|
|
(452.0 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of revenue |
|
|
(1.9)% |
|
|
|
0.8% |
|
|
|
|
|
|
|
|
|
Interest and other income (expense), net, consists primarily of interest income earned on
marketable securities offset by interest expense incurred related to the Companys convertible debt
offering signed in March 2008. The net change in these amounts in the periods presented is
principally due to (i) an increase of $1.7 million in interest expense for the six months ended
June 30, 2009 related to the convertible debt offering due to having a full period of interest
expense in the 2009 period as compared to only partial period during the same 2008 period, and (ii)
lower balances in marketable securities in 2009, coupled with lower interest rates, resulting in a
decrease of $1.4 million and $1.8 million in interest income for the three and six months ended
June 30, 2009, respectively.
22
Stock-Based Compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
(in thousands) |
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
Sales, marketing and administrative expense |
|
$ |
5,243 |
|
|
$ |
4,538 |
|
|
$ |
10,484 |
|
|
$ |
9,042 |
|
Research and development expense |
|
|
1,074 |
|
|
|
610 |
|
|
|
2,515 |
|
|
|
1,256 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stock-based compensation expense |
|
$ |
6,317 |
|
|
$ |
5,148 |
|
|
$ |
12,999 |
|
|
$ |
10,298 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of revenue |
|
|
7.1% |
|
|
|
9.0% |
|
|
|
7.7% |
|
|
|
9.5% |
|
We granted approximately 1.3 million and 1.6 million options in the first six months of 2009
and 2008, respectively, with a per option grant date weighted average fair value of $13.12 and
$14.22, respectively. In addition, in 2009 we granted approximately 186,000 restricted stock units
with a weighted average grant date fair value of $34.77. We recognize stock-based compensation
expense on an accelerated basis in accordance with FIN 28, which effectively results in the
recognition of approximately 60% of the total compensation expense for a particular option within
12 months of its grant date. The increase in stock-based compensation expense in the three and six
months ended June 30, 2009 compared to the same periods in 2008 is due primarily to the
amortization of prior year grants during the first half of 2009, decrease in options granted during
the first half 2009 at a lower weighted average fair value as compared to the same period in 2008
and an increase due to the grant of restricted stock units during the first half of 2009 with no
comparable grants during the same period in 2008. Restricted stock units tend to have a higher
associated stock-based compensation expense as they are valued at the full market price on the day
of grant.
Liquidity and Capital Resources
Since our inception in 1997, we have incurred significant losses and as of June 30, 2009, we
had an accumulated deficit of approximately $197.0 million. We expect our sales, marketing and
administrative expense and research and development expense will continue to grow and, as a result,
we will need to generate significant net sales to increase profitability. To date, our operations
have been funded primarily with proceeds from the sale of our securities.
In March 2008, we issued $230.0 million principal amount of 2.25% Convertible Senior Notes due
2013 (the Notes). The net proceeds from the offering, after deducting the initial purchasers
discount and costs directly related to the offering, were approximately $208.4 million. We will pay
2.25% interest per annum on the principal amount of the Notes, payable semi-annually in arrears in
cash on March 15 and September 15 of each year. The Notes mature on March 15, 2013.
Cash, cash equivalents and short-term and long-term marketable securities, was $180.8 million
at June 30, 2009 and $223.4 million at December 31, 2008. The decrease was due primarily to the
payments of $10.0 million related to our investment in Progentix, $10.0 million related to Osteocel
milestones and $24.1 million related to our acquisition of Cervitech.
Net cash provided by operating activities was $7.6 million in the first half of 2009 compared
to $6.1 million used in operating activities in the same period in 2008, an increase of $13.7
million in net cash provided by operating activities. We spent an incremental $3.4 million during
the first six months of 2009 as compared to the same period in 2008 for inventory to support our
increased operations and growing business, offset by an increase in cash generated from our
improved operating results in 2009 as compared to 2008.
Net cash used in investing activities was $9.9 million in the first half of 2009 compared to
$133.1 million in the same period in 2008. The decrease in net cash used in investing activities of
$123.2 million is primarily due to the net change of $148.3 million in the cash provided by the
activity in our investment portfolio and to a $13.2 million decrease in capital asset purchases,
offset by an increase of $37.8 million used in acquisition related cash payments for our investment
in Progentix, payment of Osteocel milestone and Cervitech acquisition.
Net cash provided by financing activities was $6.3 million in the first half of 2009 compared
to $213.5 million in the same period in 2008. The change in net cash provided by financing
activities of $207.2 million is primarily due to the receipt of net proceeds of $208.4 million from
the issuance of convertible debt in March 2008.
We expect that cash provided by operating activities may fluctuate in future periods as a
result of a number of factors, including fluctuations in our working capital requirements and of
our capital expenditures for additional loaner assets, our operating results, and
23
cash used in any
future acquisitions. In addition, we expect to incur additional capital expenditures for leasehold
improvements for the new headquarters facility. We have sufficient cash and investments on hand to
finance our operations for the foreseeable future.
Commitments
Progentix Investment
On January 13, 2009 (the Investment Date), we completed the purchase of forty percent (40%) of
the capital stock of Progentix Orthobiology, B.V., a company organized under the laws of the
Netherlands (Progentix), from existing shareholders pursuant to a Preferred Stock Agreement for $10
million in cash. Additionally, we, Progentix and the shareholders of Progentix entered into an
Option Purchase Agreement dated January 13, 2009 (the Option Agreement), whereby we may be
obligated, upon the achievement of certain milestones by Progentix within two years, to purchase
the remaining sixty percent (60%) of capital stock of Progentix for $45 million, payable in a
combination of cash or NuVasive common stock at our sole discretion, subject to certain adjustments
(the Remaining Shares). We may also be obligated in the event that Progentix achieves the
milestones contemplated above within the requisite two year period to make additional payments to
Progentix shareholders, excluding NuVasive, of up to an aggregate total of $25 million, payable in
a combination of cash or stock at our sole discretion, upon completion of additional milestones and
dependent on our sales success. We also have the right under the Option Agreement to purchase the
Remaining Shares at any time between the second anniversary of the Option Agreement and the fourth
anniversary of the Option Agreement (the Option Period) for $35 million, payable in a combination
of cash or NuVasive common stock at our sole discretion, and in certain circumstances where we
achieve in excess of a certain annual sales run rate on Progentix products during the Option
Period, we may be required to purchase the Remaining Shares for $35 million. We also entered into a
Distribution Agreement with Progentix dated January 13, 2009, whereby Progentix appointed us as its
exclusive distributor for certain Progentix products. The Distribution Agreement shall remain in
effect for a term of ten years unless earlier terminated in accordance with its terms.
We entered into a Senior Secured Facility Agreement with Progentix dated January 13, 2009 (the
Facility Agreement) whereby Progentix may borrow up to $5 million from us to fund ongoing clinical
and regulatory efforts (the Loan). The Loan accrues interest at a rate of six percent (6%) per
year. The total amount of the Loan and any related accrued interest may be paid in cash or applied
against any potential future purchase price of the Remaining Shares. We are not obligated to
provide any additional funding to Progentix other than as stipulated in the Loan. Progentix
borrowed $1 million under the Loan at the Investment Date.
Cervitech® Inc. Acquisition
On May 8, 2009, the Company completed the purchase of all of the outstanding shares of
Cervitech, Inc., a Delaware corporation (Cervitech), pursuant to a Share Purchase Agreement dated
April 22, 2009 (the Purchase Agreement) for an initial payment of approximately $48 million
consisting of cash totaling approximately $24 million and the issuance of 638,261 shares of NuVasive common stock
(the Shares) to certain stockholders of Cervitech. Cervitech, a New Jersey based company, is
focused on the clinical approval of the PCM® cervical disc system, a motion preserving total disc
replacement device.
NuVasive may also be obligated, in the event that Cervitech receives FDA approval of the
device, to make an additional payment of $33 million, payable in either cash or a combination of
cash and up to half in NuVasives common stock, at the Companys election.
Convertible Senior Notes
In March 2008, we issued $230.0 million principal amount of 2.25% Convertible Senior Notes
(the Notes), which includes the subsequent exercise of the initial purchasers option to purchase
an additional $30.0 million aggregate principal amount of the Notes. The net proceeds from the
offering, after deducting the initial purchasers discount and costs directly related to the
offering, were approximately $208.4 million. We will pay 2.25% interest per annum on the principal
amount of the Notes, payable semi-annually in arrears in cash on March 15 and September 15 of each
year. The Notes mature on March 15, 2013 (the Maturity Date).
Osteocel Biologics Business Acquisition
In connection with the Asset Purchase Agreement and Manufacturing Agreement, each as amended,
that were entered into in connection with the Osteocel Biologics Business Acquisition, we are
required to make an additional non-contingent payment of $12.5 million to Osiris Therapeutics, Inc.
(Osiris) during 2009. Also, we will make an additional milestone-based contingent payment to Osiris
in the amount of $15 million related to a sales performance milestone. Both the contingent and
non-contingent payments to Osiris are payable in either cash or a combination of cash and NuVasive
common stock, at our election.
24
Building Leases
On November 6, 2007, we entered into a 15-year lease agreement for the purpose of relocating
our corporate headquarters to an approximately 140,000 square foot two-building campus style
complex. Rental payments consist of base rent of $2.43 per square foot, escalating at an annual
rate of three percent over the 15-year period of the lease, plus related operating expenses.
Relocation to the new facility began in the first quarter of 2008 and was completed in August 2008.
In addition, through options to acquire additional space in the project and to require the
construction of an additional building on the campus, the agreement provides for facility expansion
rights to an aggregate of more than 300,000 leased square feet. Under the terms of this lease, and
the lease of our previous headquarters, we are required to make minimum lease payments, including
operating expenses as follows:
|
|
|
|
|
Year |
|
Total |
|
(in thousands) |
|
|
|
|
Remaining 2009 |
|
$ |
1,865 |
|
2010 |
|
|
7,143 |
|
2011 |
|
|
7,386 |
|
2012 |
|
|
7,174 |
|
2013 |
|
|
6,473 |
|
Thereafter |
|
|
75,653 |
|
|
|
|
|
|
|
$ |
105,694 |
|
|
|
|
|
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Our exposure to interest rate risk at June 30, 2009 is related to our investment portfolio
which consists largely of debt instruments of high quality corporate issuers and the U.S.
government and its agencies. Due to the short-term nature of these investments, we have assessed
that there is no material exposure to interest rate risk arising from our investments. Fixed rate
investments and borrowings may have their fair market value adversely impacted from changes in
interest rates. At June 30, 2009, we did not hold any material asset-backed investment securities
and in 2009 and 2008, we did not realize any losses related to asset-backed investment securities.
Interest Rate Risk. Our exposure to market risk for changes in interest rates relates
primarily to our investment portfolio. The fair market value of fixed rate securities may be
adversely impacted by fluctuations in interest rates while income earned on floating rate
securities may decline as a result of decreases in interest rates. Under our current policies, we
do not use interest rate derivative instruments to manage exposure to interest rate changes. We
attempt to ensure the safety and preservation of our invested principal funds by limiting default
risk, market risk and reinvestment risk. We mitigate default risk by investing in investment grade
securities. We have historically maintained a relatively short average maturity for our investment
portfolio, and we believe a hypothetical 10% adverse move in interest rates along the entire
interest rate yield curve would not materially affect the fair value of our interest sensitive
financial instruments.
Foreign Currency Exchange Risk. We have operated mainly in the United States of America, and
the majority of our sales since inception have been made in U.S. dollars. Currently, a majority of
our sales to international markets have been to independent distributors in transactions conducted
in U.S. dollars; our other sales in international markets, currently the United Kingdom and
Germany, are through local subsidiaries which sell directly to health care providers in local
currencies. To date, we have not had any material exposure to foreign currency rate fluctuations.
Item 4. Controls and Procedures
Disclosure Controls and Procedures. We maintain disclosure controls and procedures that are
designed to ensure that information required to be disclosed in our reports under the Securities
Exchange Act of 1934, as amended (Exchange Act), is recorded, processed, summarized and reported
within the timelines specified in the SECs rules and forms, and that such information is
accumulated and communicated to our management, including our Chief Executive Officer and Chief
Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. In
designing and evaluating the disclosure controls and procedures, management recognizes that any
controls and procedures, no matter how well designed and operated, can only provide reasonable
assurance of achieving the desired control objectives, and in reaching a reasonable level of
assurance management necessarily is required to apply its judgment in evaluating the cost-benefit
relationship of possible controls and procedures.
Under the supervision and with the participation of our management, including our Chief
Executive Officer and our Chief Financial Officer, we carried out an evaluation of the
effectiveness of the Companys disclosure controls and procedures (as such term
25
is defined in
Exchange Act Rules 13a 15(e) and 15d 15(e)) as of June 30, 2009. Based on such evaluation,
our management has concluded that as of June 30, 2009, the Companys disclosure controls and
procedures are effective.
Changes in Internal Control over Financial Reporting. There has been no change to our internal
control over financial reporting during our most recent fiscal quarter that has materially
affected, or is reasonably likely to materially affect, our internal control over financial
reporting.
26
PART II. OTHER INFORMATION
Item 1A. Risk Factors
An investment in our common stock involves a high degree of risk. You should consider
carefully the risks and uncertainties described under Item 1A of Part I of our Annual Report on
Form 10-K filed with the Securities and Exchange Commission for the year ended December 31, 2008
(the Risk Factors), to which there have been no material changes, together with all other
information contained or incorporated by reference in this report before you decide to invest in
our common stock. If any of the risks described in this report or in our annual report actually
occurs, our business, financial condition, results of operations and our future growth prospects
could be materially and adversely affected. Under these circumstances, the trading price of our
common stock could decline, and you may lose all or part of your investment.
Item 4. Submission of Matters to a Vote of Security Holders
Our Annual Meeting of Stockholders was held on May 21, 2009. Our stockholders acted upon the
following two proposals at the meeting:
1. To elect three Class II directors to hold office until the 2012 Annual Meeting of
Stockholders and until their successors are elected and qualified.
2. To ratify the appointment of Ernst & Young LLP as the Companys independent registered
public accounting firm for the fiscal year ending December 31, 2009.
With respect to the first proposal, our stockholders voted and approved the election of three
Class II directors to hold office until the 2012 Annual Meeting of Stockholders or until their
earlier resignation or removal. The directors elected and the votes cast were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
Names of Directors Elected |
|
Number of Shares: |
|
For |
|
Withheld |
Peter C. Farrell, Ph.D., AM |
|
|
|
|
|
|
33,035,166 |
|
|
|
225,063 |
|
Lesley H. Howe |
|
|
|
|
|
|
33,033,246 |
|
|
|
226,983 |
|
Eileen M. Moore |
|
|
|
|
|
|
31,708,223 |
|
|
|
1,552,006 |
|
The following are the other members of our board of directors whose terms continued after the
meeting: Alexis Lukianov; Jack R. Blair; Robert J. Hunt; and Hansen A. Yuan, M.D.
At the Annual Meeting, our stockholders also voted upon and ratified the Audit Committees
selection of Ernst & Young LLP as the Companys independent registered public accounting firm for
the fiscal year ending December 31, 2009, by the following vote:
Number of Shares Voted
|
|
|
|
|
|
|
For |
|
Against |
|
Abstain |
|
Broker Non-Votes |
|
33,232,777
|
|
22,489
|
|
4,963
|
|
0 |
Item 5. Other Information
Other Events
Between May 18, 2009 and June 12, 2009, each of the following individuals, each an executive
officer of NuVasive, Inc. (NuVasive), adopted a stock trading plan for trading in NuVasives
common stock, currently held or issuable upon the exercise of stock options, in accordance
with the guidelines specified by the Securities and Exchange Commissions Rule 10b5-1 under
the Securities Exchange Act of 1934: Alexis V. Lukianov, NuVasives Chairman and Chief
Executive Officer; Keith Valentine, NuVasives President and Chief Operating Officer; Kevin C.
OBoyle, NuVasives Executive Vice President and Chief Financial Officer; Patrick Miles,
NuVasives Executive Vice President, Marketing and Development; and Jason Hannon, NuVasives
Senior Vice President and General Counsel. Each of these individuals will file Forms 4
evidencing sales under their stock trading plan as required under Section 16 of the Securities
Exchange Act of 1934. This type of trading plan allows a corporate insider to gradually
diversify holdings of company stock while minimizing any market effects of such trades by
spreading them out over an extended period of time and eliminating any market concern that
such trades were made by a person while in possession of material nonpublic
27
information. Consistent with Rule 10b5-1, NuVasives insider trading policy permits personnel to
implement Rule 10b5-1 trading plans provided that, among other things, such personnel are not in
possession of any material nonpublic information at the time they adopt such plans.
Pursuant to the stock trading plan adopted by Mr. Lukianov, commencing in August 2009 he will
sell up to 10,000 shares each month if the stock is above a prearranged minimum price, and may sell
up to 40,000 additional shares each month based on increasing price levels. Pursuant to the stock
trading plan adopted by Mr. Valentine, in September 2009 he will sell 5,000 shares if the stock is
above a prearranged minimum price, and may sell up to 5,000 additional shares based on increasing
price levels. Pursuant to the trading plan adopted by Mr. OBoyle, in September 2009 he will sell
10,542 shares if the stock is above a prearranged minimum price. Pursuant to the trading plan
adopted by Mr. Miles, commencing in August 2009 he will sell 2,500 shares each month if the stock
is above a prearranged minimum price, and may sell up to 5,000 additional shares each month based
on increasing price levels. Pursuant to the stock trading plan adopted by Mr. Hannon, in September
or October 2009 he will sell 20,000 shares if the stock is above a prearranged minimum price, and
may sell 5,000 additional shares based on increasing price levels.
Under each of the plans, the plans agent will undertake to sell specified numbers of shares
each month if the stock trades above the prearranged minimum prices. The individual stockholder
will have no control over the timing of any sales under the plan and there is no assurance that any
shares will be sold. Sales under Mr. Lukianovs plan will take effect in August 2009 and will
expire in January 2010; the sale under Mr. Valentines plan will take effect and expire in
September 2009; the sale under Mr. OBoyles plan will take effect and expire in September 2009;
sales under Mr. Miles plan will take effect in August 2009 and will expire in June 2010; and the
sale under Mr. Hannons plan will take effect in September 2009 and will expire in October 2009.
On May 21, 2009, the board of directors of NuVasive (the Board) adopted a new compensation
plan for the non-employee members of the Board. Beginning in 2009, each director will receive an
annual $25,000 retainer for their service on the Board. Members of the Audit Committee also receive
an annual retainer of $25,000, with the Audit Committee chairperson receiving an additional annual
retainer of $15,000. Members of the Nominating and Governance Committee receive an annual retainer
of $5,000, with the Nominating and Governance Committee chairperson receiving an additional annual
retainer of $3,000. Members of the Compensation Committee receive an annual retainer of $7,500,
with the Compensation Committee chairperson receiving an additional annual retainer of $5,000. No
compensation is paid to any director who is also an employee of the Company.
Compensatory Arrangements of Certain Officers
On August 5, 2009, the Company entered into an amendment to the compensatory letter agreement
(the Compensatory Letter Amendment) with our CEO and Chairman, Alex Lukianov, a named executive
officers (as defined in Item 402(a)(3) of Regulation S-K). The Compensatory Letter Amendment
provides that Mr. Lukianovs severance benefit and the vesting of his outstanding unvested equity
awards shall immediately accelerate if his service as the CEO and/or member of the board of
directors of the Company ceases due to death or permanent disability. A copy of the Compensatory
Letter Amendment is furnished as Exhibit 10.1, and is hereby incorporated by reference.
28
Item 6. Exhibits
EXHIBIT INDEX
|
|
|
Exhibit No |
|
Description |
2.1(1)
|
|
Share Purchase Agreement, by and among NuVasive, Inc. and the stockholders of Cervitech,
Inc., as listed therein, dated April 22, 2009 |
|
|
|
3.1 (2)
|
|
Restated Certificate of Incorporation |
|
|
|
3.2 (3)
|
|
Restated Bylaws |
|
|
|
10.1#
|
|
Amendment No. 2 to Compensation Letter Agreement, dated August 5, 2009, between
NuVasive, Inc. and Alexis V. Lukianov |
|
|
|
31.1
|
|
Certification of Chief Executive Officer pursuant to Rules 13a-14 and 15d-14 promulgated
under the Securities Exchange Act of 1934 |
|
|
|
31.2
|
|
Certification of Chief Financial Officer pursuant to Rules 13a-14 and 15d-14 promulgated
under the Securities Exchange Act of 1934 |
|
|
|
32 *
|
|
Certifications of Chief Executive Officer and Chief Financial Officer pursuant to 18
U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002 |
|
|
|
(1) |
|
Incorporated by reference to our Registration Statement on Form S-3 (File No. 333-159098)
filed with the Securities and Exchange Commission (the Commission) on May 8, 2009. |
|
(2) |
|
Incorporated by reference to our Quarterly Report on Form 10-Q filed with the Commission on August 13, 2004. |
|
(3) |
|
Incorporated by reference to our Current Report on Form 8-K filed with the Commission on December 15, 2008. |
|
|
|
The Commission has granted confidential treatment to us with respect to certain omitted portions of this exhibit (indicated
by asterisks). We have filed separately with the Commission an unredacted copy of the exhibit. |
|
# |
|
Indicates management contract or compensatory plan. |
|
* |
|
These certifications are being furnished solely to accompany this quarterly report pursuant
to 18 U.S.C. Section 1350, and are not being filed for purposes of Section 18 of the
Securities Exchange Act of 1934 and are not to be incorporated by reference into any filing of
NuVasive, Inc., whether made before or after the date hereof, regardless of any general
incorporation language in such filing. |
29
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
NuVasive, Inc.
Date: August 6, 2009
|
|
|
|
|
|
|
|
|
By: |
/s/ Alexis V. Lukianov
|
|
|
|
Alexis V. Lukianov |
|
|
|
Chairman and Chief Executive Officer |
|
|
Date: August 6, 2009
|
|
|
|
|
|
|
|
|
By: |
/s/ Kevin C. O'Boyle
|
|
|
|
Kevin C. O'Boyle |
|
|
|
Executive Vice President and
Chief Financial Officer |
|
30
EXHIBIT INDEX
|
|
|
Exhibit No |
|
Description |
2.1(1)
|
|
Share Purchase Agreement, by and among NuVasive, Inc. and the stockholders of
Cervitech, Inc., as listed therein, dated April 22, 2009 |
|
|
|
3.1 (2)
|
|
Restated Certificate of Incorporation |
|
|
|
3.2 (3)
|
|
Restated Bylaws |
|
|
|
10.1#
|
|
Amendment No. 2 to Compensation Letter Agreement, dated August 5, 2009, between
NuVasive, Inc. and Alexis V. Lukianov |
|
|
|
31.1
|
|
Certification of Chief Executive Officer pursuant to Rules 13a-14 and 15d-14
promulgated under the Securities Exchange Act of 1934 |
|
|
|
31.2
|
|
Certification of Chief Financial Officer pursuant to Rules 13a-14 and 15d-14
promulgated under the Securities Exchange Act of 1934 |
|
|
|
32 *
|
|
Certifications of Chief Executive Officer and Chief Financial Officer pursuant to
18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002 |
|
|
|
(1) |
|
Incorporated by reference to our Registration Statement on Form S-3 (File No. 333-159098)
filed with the Securities and Exchange Commission (the Commission) on May 8, 2009. |
|
(2) |
|
Incorporated by reference to our Quarterly Report on Form 10-Q filed with the Commission on
August 13, 2004. |
|
(3) |
|
Incorporated by reference to our Current Report on Form 8-K filed with the Commission on
December 15, 2008. |
|
|
|
The Commission has granted confidential treatment to us with respect to certain omitted
portions of this exhibit (indicated by asterisks). We have filed separately with the
Commission an unredacted copy of the exhibit. |
|
# |
|
Indicates management contract or compensatory plan. |
|
* |
|
These certifications are being furnished solely to accompany this quarterly report pursuant
to 18 U.S.C. Section 1350, and are not being filed for purposes of Section 18 of the
Securities Exchange Act of 1934 and are not to be incorporated by reference into any filing of
NuVasive, Inc., whether made before or after the date hereof, regardless of any general
incorporation language in such filing. |
31