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8-K - FORM 8-K - NUVASIVE INC | a54063e8vk.htm |
Exhibit 99.1
PRESS RELEASE
Contact: |
Investors: | |
Kevin C. OBoyle |
Patrick F. Williams | |
EVP & Chief Financial Officer |
Vice President, Finance & Investor Relations | |
NuVasive, Inc. |
NuVasive, Inc. | |
858-909-1998 |
858-638-5511 | |
investorrelations@nuvasive.com |
investorrelations@nuvasive.com | |
Media: | ||
Jason Rando | ||
The Ruth Group | ||
646-536-7025 | ||
jrando@theruthgroup.com |
NUVASIVE REPORTS THIRD QUARTER 2009 FINANCIAL RESULTS
Increases 2009 Guidance for Revenue and Earnings per Share
Third Quarter 2009 Highlights:
| Total revenue of $94.9 million; up 41.8% from third quarter 2008 and up 7.3% from second quarter 2009 | |
| Gross margin of 80.6% compared to 81.8% for third quarter 2008 and to 81.1% for second quarter 2009 | |
| GAAP earnings of $5.1 million or $0.13 per share; Non-GAAP earnings of $11.0 million or $0.28 per share |
SAN DIEGO, October 20, 2009 NuVasive, Inc. (Nasdaq: NUVA), a medical device company focused on
developing products for minimally disruptive surgical treatments for the spine, announced today
financial results for the quarter ended September 30, 2009.
NuVasive reported third quarter revenue of $94.9 million, a 41.8% increase over the $66.9 million
for the third quarter 2008 and a 7.3% increase over the $88.5 million for the second quarter 2009.
Gross profit for the third quarter 2009 was $76.5 million and gross margin was 80.6%, compared to a
gross profit of $54.7 million and a gross margin of 81.8% for the third quarter 2008. For the
second quarter 2009, gross profit was $71.8 million and gross margin was 81.1%.
Total operating expenses for the third quarter 2009 were $70.4 million compared to $77.7 million in
the third quarter 2008 and $67.3 million in the second quarter 2009. Operating expenses include
$0.6 million of acquisition related costs, a $2.0 million reversal of a leasehold termination charge
and $0.8 million related to intellectual property litigation.
On a GAAP basis, the Company reported net income of $5.1 million, or $0.13 per share, for the third
quarter 2009.
On a Non-GAAP basis, the Company reported net income of $11.0 million, or $0.28 per share, for the
third quarter 2009. The Non-GAAP earnings per share calculations for the third quarter exclude (i)
stock-based compensation of $5.2 million; (ii) amortization of acquired intangible assets of $1.4
million; (iii) acquisition related costs of $0.6 million; (iv) intellectual property litigation
costs of $0.8 million, and (v) the reversal of a leasehold termination charge of $2.0 million.
Cash, cash equivalents and short and long-term marketable securities were $200.2 million at
September 30, 2009.
Alex Lukianov, Chairman and Chief Executive Officer, said, NuVasive is pioneering the lateral
approach with our proprietary XLIF® procedure and MAS® platform. We continue
to take market share and expand our addressable market by broadening the application of our
technology throughout the spine. We are the only company with the ability to laterally address a
wide range of applications in the lumbar and thoracic spine, from single level procedures to
complex multi level deformity corrections. We are pleased with our financial performance in the
third quarter of 2009, and are confident in our strategy to become the #4 global spine company.
Updated 2009 Financial Guidance
NuVasive is updating its full year 2009 financial guidance as follows:
NuVasive is updating its full year 2009 financial guidance as follows:
Revenue:
| $365 million to $367 million; up from previous guidance of $360 million to $365 million |
Gross Margin:
| Gross Margin of approximately 81% |
EPS:
| GAAP: earnings per share of $0.11 to $0.14; up from previous guidance of $0.06 to $0.08 |
| Earnings per share of $0.27 to $0.30 excluding adjustments per the enclosed table; up from previous guidance of $0.25 to $0.27 |
Reconciliation of Non-GAAP Information
Management uses certain Non-GAAP financial measures such as Non-GAAP earnings per share, which exclude intellectual property litigation expenses, the reversal of leasehold termination charges, acquisition related costs, stock-based compensation, and the amortization of acquired intangible assets. Management does not consider these costs in evaluating the continuing operations of the Company. Therefore, management calculates the Non-GAAP financial measures provided in this earnings release excluding these costs and uses these Non-GAAP financial measures to enable it to analyze further, and more consistently, the period-to-period financial performance of its core business operations. Management believes that providing investors with these Non-GAAP measures gives them additional important information to enable them to assess, in the same way management assesses, the Companys current and future continuing operations. These Non-GAAP measures are not in accordance with, or an alternative for, GAAP, and may be different from Non-GAAP measures used by other companies. Set forth below are reconciliations of the Non-GAAP financial measures to the comparable GAAP financial measure.
Management uses certain Non-GAAP financial measures such as Non-GAAP earnings per share, which exclude intellectual property litigation expenses, the reversal of leasehold termination charges, acquisition related costs, stock-based compensation, and the amortization of acquired intangible assets. Management does not consider these costs in evaluating the continuing operations of the Company. Therefore, management calculates the Non-GAAP financial measures provided in this earnings release excluding these costs and uses these Non-GAAP financial measures to enable it to analyze further, and more consistently, the period-to-period financial performance of its core business operations. Management believes that providing investors with these Non-GAAP measures gives them additional important information to enable them to assess, in the same way management assesses, the Companys current and future continuing operations. These Non-GAAP measures are not in accordance with, or an alternative for, GAAP, and may be different from Non-GAAP measures used by other companies. Set forth below are reconciliations of the Non-GAAP financial measures to the comparable GAAP financial measure.
Reconciliation of Third Quarter 2009 Results
(in thousands, except per share amounts) | $ | Per Share | ||||||
GAAP net income |
$ | 5,064 | $ | 0.13 | ||||
IP litigation costs |
780 | 0.02 | ||||||
Reversal of leasehold termination charge |
(1,997 | ) | (0.05 | ) | ||||
Acquisition related costs |
621 | 0.02 | ||||||
Earnings excluding other adjustments |
4,468 | 0.11 | ||||||
Non-cash stock-based compensation |
5,166 | 0.13 | ||||||
Amortization of acquired intangible assets |
1,364 | 0.04 | ||||||
Non-GAAP earnings |
$ | 10,998 | $ | 0.28 | ||||
Diluted weighted shares outstanding |
39,216 | |||||||
Reconciliation of Year-to-Date 2009 Results
(in thousands, except per share amounts) | $ | Per Share | ||||||
GAAP net income |
$ | 3,527 | $ | 0.09 | ||||
IP litigation costs |
3,408 | 0.09 | ||||||
Reversal of leasehold termination charge |
(1,997 | ) | (0.05 | ) | ||||
Acquisition related costs |
3,096 | 0.08 | ||||||
Earnings excluding other adjustments |
8,034 | 0.21 | ||||||
Non-cash stock-based compensation |
18,165 | 0.47 | ||||||
Amortization of acquired intangible assets |
4,071 | 0.11 | ||||||
Non-GAAP earnings |
$ | 30,270 | $ | 0.79 | ||||
Diluted weighted shares outstanding |
38,384 | |||||||
Reconciliation of Full Year 2009 Guidance
Range for Year Ending | ||||||||
December 31, 2009 | ||||||||
(in thousands, except per share amounts) | Low | High | ||||||
GAAP net earnings per share |
$ | 0.11 | $ | 0.14 | ||||
IP litigation costs |
0.13 | 0.13 | ||||||
Reversal of leasehold termination charge |
(0.05 | ) | (0.05 | ) | ||||
Acquisition related costs |
0.08 | 0.08 | ||||||
Earnings per share excluding other adjustments |
0.27 | 0.30 | ||||||
Non-cash stock-based compensation |
0.64 | 0.64 | ||||||
Amortization of acquired intangible assets |
0.13 | 0.13 | ||||||
Non-GAAP earnings per share |
$ | 1.04 | $ | 1.07 | ||||
Diluted weighted shares outstanding |
38,800 | 38,800 | ||||||
Conference Call
NuVasive will hold a conference call today at 5:30 p.m. ET / 2:30 p.m. PT to discuss the results. The dial-in numbers are 1-877-407-4018 for domestic callers and 1-201-689-8471 for international callers. A live webcast of the conference call will be available online from the investor relations page of the Companys corporate website at www.nuvasive.com.
NuVasive will hold a conference call today at 5:30 p.m. ET / 2:30 p.m. PT to discuss the results. The dial-in numbers are 1-877-407-4018 for domestic callers and 1-201-689-8471 for international callers. A live webcast of the conference call will be available online from the investor relations page of the Companys corporate website at www.nuvasive.com.
After the live webcast, the call will remain available on NuVasives website, www.nuvasive.com,
through November 20, 2009. In addition, a telephonic replay of the call will be available until
November 3, 2009. The replay dial-in numbers are 1-877-660-6853 for domestic callers and
1-201-612-7415 for international callers. Please use account number 3055 and conference ID number
331825.
About NuVasive
NuVasive 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 $4.6 billion U.S. spine implant market. Additionally, the Company has expanded into the $1.5 billion global biologics market, the $1.5 billion international market, and is developing products for the emerging motion preservation market.
NuVasive 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 $4.6 billion U.S. spine implant market. Additionally, the Company has expanded into the $1.5 billion global biologics market, the $1.5 billion 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. Having redefined spine
surgery with the MAS platforms lateral approach, known as eXtreme Lateral Interbody Fusion, or
XLIF®, NuVasive has built an entire spine franchise. With nearly 50 products today
spanning lumbar, thoracic and cervical applications, the Company will continue to expand and evolve
its offering predicated on its R&D focus and dedication to outstanding service levels supported by
a culture of Absolute Responsiveness®.
NuVasive cautions you that statements included in this press release that are not a description of
historical facts are forward-looking statements that involve risks, uncertainties, assumptions and
other factors which, if they do not materialize or prove correct, could cause NuVasives results to
differ materially from historical results or those expressed or implied by such forward-looking
statements. The potential risks and uncertainties that could cause actual growth and results to
differ materially include, but are not limited to: the risk that the Companys revenue or
profitability projections may prove incorrect because of unexpected difficulty in generating sales
or achieving anticipated profitability; the uncertain process of seeking regulatory approval or
clearance for NuVasives products or devices, including risks that such process could be
significantly delayed; the possibility that the FDA may require significant changes to NuVasives
products or clinical studies; the risk that products may not perform as intended and may therefore
not achieve commercial success; the risk that competitors may develop superior products or may have
a greater market position enabling more successful commercialization; the risk that additional
clinical data may call into question the benefits
of NuVasives products to patients, hospitals and surgeons; and other risks and uncertainties more
fully described in NuVasives press releases and periodic filings with the Securities and Exchange
Commission. NuVasives public filings with the Securities and Exchange Commission are available at
www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect
events or circumstances arising after the date on which it was made.
###
NuVasive, Inc.
Unaudited Condensed Consolidated Statement of Operations
(in thousands, except per share data)
Unaudited Condensed Consolidated Statement of Operations
(in thousands, except per share data)
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2009 | 2008 | 2009 | 2008 | |||||||||||||
Revenues |
$ | 94,916 | $ | 66,915 | $ | 263,405 | $ | 175,501 | ||||||||
Cost of goods sold |
18,417 | 12,195 | 49,901 | 30,845 | ||||||||||||
Gross profit |
76,499 | 54,720 | 213,504 | 144,656 | ||||||||||||
Operating expenses: |
||||||||||||||||
Sales, marketing and administrative |
59,761 | 54,557 | 176,391 | 135,975 | ||||||||||||
Research and development |
10,654 | 6,396 | 30,047 | 19,797 | ||||||||||||
In-process research and development |
| 16,700 | | 20,876 | ||||||||||||
Total operating expenses |
70,415 | 77,653 | 206,438 | 176,648 | ||||||||||||
Interest income (expense) and other, net |
(1,648 | ) | (146 | ) | (4,850 | ) | 764 | |||||||||
Net loss attributable to noncontrolling
interests |
628 | | 1,311 | | ||||||||||||
Total other income (expense) |
(1,020 | ) | (146 | ) | (3,539 | ) | 764 | |||||||||
Net income (loss) attributable to
NuVasive, Inc. |
$ | 5,064 | $ | (23,079 | ) | $ | 3,527 | $ | (31,228 | ) | ||||||
Net income (loss) per share attributable
to NuVasive, Inc.: |
||||||||||||||||
Basic net income (loss) per share |
$ | 0.13 | $ | (0.64 | ) | $ | 0.10 | $ | (0.88 | ) | ||||||
Diluted net income (loss) per share |
$ | 0.13 | $ | (0.64 | ) | $ | 0.09 | $ | (0.88 | ) | ||||||
Weighted average shares basic |
37,733 | 35,931 | 37,008 | 35,674 | ||||||||||||
Weighted average shares diluted |
39,216 | 35,931 | 38,384 | 35,674 | ||||||||||||
Stock-based compensation is included in
operating expenses in the following
categories: |
||||||||||||||||
Sales, marketing and administrative |
$ | 4,265 | $ | 4,499 | $ | 14,748 | $ | 13,541 | ||||||||
Research and development |
901 | 922 | 3,417 | 2,178 | ||||||||||||
$ | 5,166 | $ | 5,421 | $ | 18,165 | $ | 15,719 | |||||||||
NuVasive, Inc.
Unaudited Condensed Consolidated Balance Sheets
(in thousands)
Unaudited Condensed Consolidated Balance Sheets
(in thousands)
September 30, | December 31, | |||||||
2009 | 2008 | |||||||
(In thousands, except par value) | ||||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 134,276 | $ | 132,318 | ||||
Short-term marketable securities |
55,915 | 45,738 | ||||||
Accounts receivable, net |
51,245 | 51,622 | ||||||
Inventory |
85,892 | 68,834 | ||||||
Prepaid expenses and other current assets |
3,925 | 3,466 | ||||||
Total current assets |
331,253 | 301,978 | ||||||
Property and equipment, net |
77,543 | 73,686 | ||||||
Long-term marketable securities |
10,032 | 45,305 | ||||||
Goodwill |
102,264 | 2,332 | ||||||
Intangible assets, net |
104,601 | 54,767 | ||||||
Other assets |
7,337 | 9,338 | ||||||
Total assets |
$ | 633,030 | $ | 487,406 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable and accrued liabilities |
$ | 23,183 | $ | 26,633 | ||||
Accrued payroll and related expenses |
20,568 | 17,132 | ||||||
Acquisition related liabilities |
15,414 | | ||||||
Royalties payable |
2,201 | 1,722 | ||||||
Total current liabilities |
61,366 | 45,487 | ||||||
Senior convertible notes |
230,000 | 230,000 | ||||||
Long-term acquisition related liabilities |
30,318 | 12,111 | ||||||
Other long-term liabilities |
29,099 | 12,177 | ||||||
Commitments and contingencies |
||||||||
Noncontrolling interests |
13,689 | | ||||||
Stockholders equity: |
||||||||
Common stock |
38 | 36 | ||||||
Additional paid-in capital |
460,290 | 383,293 | ||||||
Accumulated other comprehensive income (loss) |
211 | (190 | ) | |||||
Accumulated deficit |
(191,981 | ) | (195,508 | ) | ||||
Total stockholders equity |
268,558 | 187,631 | ||||||
Total liabilities and stockholders equity |
$ | 633,030 | $ | 487,406 | ||||
NuVasive, Inc.
Unaudited Condensed Consolidated Statements of Cash Flows
(in thousands)
Unaudited Condensed Consolidated Statements of Cash Flows
(in thousands)
Nine Months Ended September 30, | ||||||||
2009 | 2008 | |||||||
Operating activities: |
||||||||
Net income (loss) |
$ | 3,527 | $ | (31,228 | ) | |||
Adjustments to reconcile net income (loss) to net
cash provided by (used in) operating activities: |
||||||||
Depreciation and amortization |
22,005 | 15,671 | ||||||
In-process research and development |
| 20,876 | ||||||
Stock-based compensation |
18,165 | 15,719 | ||||||
Leasehold abandonment |
(1,997 | ) | 4,486 | |||||
Noncontrolling interest |
(1,311 | ) | | |||||
Allowance for doubtful accounts |
1,175 | 410 | ||||||
Allowance for excess and obsolete inventory |
2,470 | (3 | ) | |||||
Other non-cash adjustments |
2,248 | 1,019 | ||||||
Changes in operating assets and liabilities: |
||||||||
Accounts receivable |
(329 | ) | (18,986 | ) | ||||
Inventory |
(19,027 | ) | (22,136 | ) | ||||
Prepaid expenses and other current assets |
788 | (941 | ) | |||||
Accounts payable and accrued liabilities |
2,410 | 3,898 | ||||||
Accrued payroll and related expenses |
2,742 | 1,778 | ||||||
Net cash provided by (used in) operating activities |
32,866 | (9,437 | ) | |||||
Investing activities: |
||||||||
Cash paid for acquisitions |
(24,055 | ) | (41,256 | ) | ||||
Investment in Progentix |
(10,000 | ) | | |||||
Acquisition related milestone payments |
(10,000 | ) | | |||||
Purchases of property and equipment |
(21,250 | ) | (34,161 | ) | ||||
Purchases of short-term marketable securities |
(46,678 | ) | (83,069 | ) | ||||
Sales of short-term marketable securities |
56,365 | 29,842 | ||||||
Purchases of long-term marketable securities |
(17,964 | ) | (51,390 | ) | ||||
Sales of long-term marketable securities |
32,971 | 14,778 | ||||||
Other assets |
| 544 | ||||||
Net cash used in investing activities |
(40,611 | ) | (164,712 | ) | ||||
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 |
9,618 | 8,480 | ||||||
Net cash provided by financing activities |
9,618 | 216,622 | ||||||
Effect of exchange rate changes on cash |
85 | | ||||||
Increase in cash and cash equivalents |
1,958 | 42,473 | ||||||
Cash and cash equivalents at beginning of year | 132,318 | 61,915 | ||||||
Cash and cash equivalents at end of year | $ | 134,276 | $ | 104,388 | ||||