NuVasive, Inc. 4Q Profit Falls on Expenses

SAN DIEGO, Feb. 25 /PRNewswire-FirstCall/ --NuVasive, Inc. , a medical device company focused on developing products for minimally disruptive surgical treatments for the spine, announced today financial results for the quarter and for the full year ended December 31, 2009.

NuVasive reported fourth quarter revenue of $106.9 million, a 43.4% increase over the $74.6 million for the fourth quarter 2008 and a 12.7% increase over the $94.9 million for the third quarter 2009. Full year 2009 revenue was $370.3 million, a 48.1% increase over the $250.1 million reported for the full year 2008.

The financial results announced today incorporate the reclassification of certain expense items in order to best reflect their true economic character in the income statement and to align to prevalent industry practice. Moving forward, certain expenses will be classified as indicated in an attached reference table and have been reclassified in prior years for comparative purposes.

Gross profit for the fourth quarter 2009 was $88.9 million and gross margin was 83.2%, compared to a gross profit of $63.8 million and a gross margin of 85.5% for the fourth quarter 2008. For the third quarter 2009, gross profit was $79.0 million and gross margin was 83.3%. Gross profit for the full year 2009 was $309.2 million and gross margin was 83.5%, compared to a gross profit of $211.1 million and gross margin of 84.4% for the full year 2008.

Total operating expenses for the fourth quarter 2009 were $84.7 million compared to $59.6 million in the fourth quarter 2008 and $73.0 million in the third quarter 2009. Full year 2009 operating expenses were $297.9 million compared to $238.9 million reported for the full year 2008. The higher operating expenses in 2009 resulted primarily from additional costs associated with higher revenue, infrastructure expansion, and research and development.

On a GAAP basis, the Company reported net income of $2.3 million, or $0.06 per share, for the fourth quarter 2009, and net income of $5.8 million, or $0.15 per share for the full year 2009.

On a Non-GAAP basis, the Company reported net income of $11.1 million, or $0.28 per share, for the fourth quarter 2009, and net income of $41.4 million, or $1.07 per share, for the full year 2009. The Non-GAAP earnings per share calculations for the fourth quarter and full year exclude, respectively, (i) stock-based compensation of $5.6 million and $23.8 million; (ii) amortization of intangible assets of $1.3 million and $5.3 million; (iii) acquisition related items of $0.7 million and $3.8 million; (iv) intellectual property litigation expenses of $1.2 million and $4.6 million, and (v) the reversal of a leasehold termination charge of nil and $2.0 million.

Cash, cash equivalents and short and long-term marketable securities were $204.7 million at December 31, 2009.

Alex Lukianov, Chairman and Chief Executive Officer, said, “We achieved outstanding revenue growth of nearly 50%, a record non-GAAP operating margin of approximately 13% and more than $45 million in operating cash flow in 2009. Continued investment in research and development, coupled with a culture that fosters innovation and Absolute Responsiveness(R) have shaped a portfolio of products capable of addressing the entire spine and keeping NuVasive years ahead of the competition. Our ability to take spine market share and to expand our addressable market with comprehensive solutions which produce better outcomes for patients, surgeons, and hospitals underscores the successful execution of our growth strategy. We look forward to 2010 as the next step in NuVasive’s evolution toward the #4 global spine company with $1 billion in revenue with even stronger profitability.”

2010 Financial Guidance

Full Year 2010:

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 items, non-cash stock-based compensation, and the amortization of 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 Company’s 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.

Reference Tables

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 Company’s corporate website at www.nuvasive.com.

After the live webcast, the call will remain available on NuVasive’s website, www.nuvasive.com, through March 27, 2010. In addition, a telephonic replay of the call will be available until March 11, 2010. 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 343838.

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 Company’s product portfolio is focused primarily on the $5.1 billion U.S. spine implant market. Additionally, the Company has expanded into the $1.7 billion global biologics market, the $1.7 billion international market, and is developing products for the emerging motion preservation market.

NuVasive’s principal product offering is based on its Maximum Access Surgery, or MAS(R) 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(R), a proprietary software-driven nerve avoidance system; MaXcess(R), 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 platform’s lateral approach, known as eXtreme Lateral Interbody Fusion, or XLIF(R), NuVasive has built an entire spine franchise. With over 55 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(R).

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 NuVasive’s 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 NuVasive’s revenue or earnings projections may turn out to be inaccurate because of the preliminary nature of the forecasts and the risk of further adjustment, or unanticipated difficulty in selling products or generating expected profitability; the uncertain process of seeking regulatory approval or clearance for NuVasive’s products or devices, including risks that such process could be significantly delayed; the possibility that the FDA may require significant changes to NuVasive’s 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 NuVasive’s products to patients, hospitals and surgeons; and other risks and uncertainties more fully described in NuVasive’s press releases and periodic filings with the Securities and Exchange Commission. NuVasive’s 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.

CONTACT: Michael J. Lambert, EVP & Chief Financial Officer,
+1-858-909-1998, investorrelations@nuvasive.com; Investors: Patrick F.
Williams Vice President, Finance & Investor Relations, +1-858-638-5511,
investorrelations@nuvasive.com, both of NuVasive, Inc.; Media: Jason Rando,
The Ruth Group, +1-646-536-7025, jrando@theruthgroup.com

Web site: http://www.nuvasive.com/

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