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8-K - FORM 8-K - NUVASIVE INCa58760e8vk.htm
Exhibit 99.1
(NUVASIVE LOGO)
PRESS RELEASE
     
Contact:
 
Investors:
Michael J. Lambert
 
Patrick F. Williams
EVP & Chief Financial Officer
 
Vice President, Finance & Investor Relations
NuVasive, Inc.
 
NuVasive, Inc.
858-909-3394
 
858-638-5511
investorrelations@nuvasive.com
 
investorrelations@nuvasive.com
 
 
 
 
 
 
 
 
Media:
 
 
Jason Rando
 
 
The Ruth Group
 
 
646-536-7025
 
 
jrando@theruthgroup.com
NUVASIVE REPORTS FOURTH QUARTER AND FULL YEAR 2010
FINANCIAL RESULTS
 
Full year 2010 total revenue of $478.2 million; up 29.1% from the full year 2009
 
Fourth quarter 2010 total revenue of $129.3 million; up 20.9% from fourth quarter 2009 and up 7.5% from third quarter 2010
 
GAAP earnings of $61.9 million, or $1.39 per share, for the fourth quarter 2010 and $78.3 million, or $1.85 per share, for the full year 2010
 
Non-GAAP earnings of $19.3 million, or $0.46 per share, for the fourth quarter 2010 and $63.0 million, or $1.52 per share, for the full year 2010
 
Operating cash flow of $65.8 million for the full year 2010; up from $46.4 million for the full year 2009
SAN DIEGO, February 23, 2011 - NuVasive, Inc. (Nasdaq: NUVA) a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, announced today financial results for the quarter and for the full year ended December 31, 2010.

 


 

NuVasive reported fourth quarter 2010 revenue of $129.3 million, a 20.9% increase over the $106.9 million for the fourth quarter 2009 and a 7.5% increase over the $120.3 million for the third quarter 2010. Full year 2010 revenue was $478.2 million, a 29.1% increase over the $370.3 million reported for the full year 2009.
Gross profit for the fourth quarter 2010 was $106.2 million and gross margin was 82.1%, compared to a gross profit of $88.9 million and a gross margin of 83.2% for the fourth quarter 2009. For the third quarter 2010, gross profit was $98.7 million and gross margin was 82.1%. Gross profit for the full year 2010 was $393.1 million and gross margin was 82.2%, compared to a gross profit of $309.2 million and gross margin of 83.5% for the full year 2009.
Total operating expenses for the fourth quarter 2010 were $94.9 million compared to $84.7 million in the fourth quarter 2009 and $89.1 million in the third quarter 2010. Full year 2010 operating expenses were $361.0 million compared to $297.9 million reported for the full year 2009. The higher operating expenses in 2010 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 $61.9 million, or $1.39 per share, for the fourth quarter 2010, and net income of $78.3 million, or $1.85 per share for the full year 2010.
On a Non-GAAP basis, the Company reported net income of $19.3 million, or $0.46 per share, for the fourth quarter 2010, and net income of $63.0 million, or $1.52 per share, for the full year 2010. The Non-GAAP earnings per share calculations for the fourth quarter and full year exclude, respectively, (i)  non-cash stock-based compensation of $6.9 million and $28.2 million; (ii) certain intellectual property litigation expenses of $1.5 million and $5.1 million; (iii) amortization of intangible assets of $1.4 million and $5.4 million; (iv) acquisition related items of $1.4 million and $3.0 million; and (v) the reversal of an income tax valuation allowance of $53.4 million and $53.4 million.
Cash, cash equivalents and short and long-term marketable securities were $229.7 million at December 31, 2010.
Alex Lukianov, Chairman and Chief Executive Officer, said, “We achieved revenue growth of nearly 30%, a record non-GAAP operating margin well over 15% and more than $65 million in operating cash flow in 2010, despite challenging spine market dynamics. We made great strides in building the body of scientific evidence in support of our unique XLIF technology to demonstrate superior clinical outcomes together with long term follow up. As our focus shifts from achieving $500 million in revenue toward the achievement of our next milestone, the evolution of NuVasive into a $1 billion revenue company, we are laser focused on maintaining the startup mentality that is the very source of NuVasive’s success as a prolific new product innovator. With speed as our competitive edge, we will rely on creativity and resourcefulness and our culture of accountability to bring more game changing innovation to our surgeon customers and deliver exceptional results to our share holders.”

 


 

2011 Full Year Financial Guidance
   
Revenue of $525 million to $535 million
 
   
GAAP EPS of $0.39 to $0.42
 
   
Non-GAAP EPS of $1.07 to $1.10
 
   
Non-GAAP Operating Margin of ~16.5%
 

2011 Guidance Reconciliation of Non-GAAP Operating Margin %
                 
    FY 10   FY 11
    Actual   Estimate
 
Gross Margin % [A]
    82.2 %     ~ 81 %
 
               
Non-GAAP Research and Development [B]
    8.0 %     ~ 8 %
Non-cash stock-based compensation
    0.7 %     ~ 1 %
Acquisition related items
    0.4 %   as incurred
 
       
GAAP research and development
    9.1 %     ~ 9 %
 
               
Non-GAAP Sales, Marketing and Administrative [C]
    58.8 %     ~ 56.5 %
Non-cash stock-based compensation
    5.2 %     ~ 5 %
Certain intellectual property litigation expenses
    1.1 %     ~ 1 %
Acquisition related items*
    0.2 %   ~ 0.5% & as incurred
 
       
GAAP sales, marketing and administrative
    65.3 %     ~ 63 %
 
               
Amortization of intangible assets
    1.1 %     ~ 1.5 %
 
               
 
       
Non-GAAP Operating Margin % [A-B-C]
    15.4 %     ~ 16.5 %
 
       
* Acquisition related items include ~ 0.5% of revenue for expenses associated with prior M&A activity and as incurred

Reconciliation of Full Year EPS Guidance
                                         
    2010 Pre-Tax   2011 Pre-Tax   2011 Net of Tax*
            Low   High   Low   High
    Actual   Range   Range   Range   Range
GAAP earnings per share**
    $ 0.64       $ 0.77       $ 0.82       $ 0.39       $ 0.42  
Non-cash stock-based compensation
    0.70       0.79       0.79       0.47       0.47  
Certain intellectual property litigation expenses
    0.13       0.13       0.13       0.08       0.08  
Amortization of intangible assets
    0.13       0.18       0.18       0.11       0.11  
Acquisition related items
    0.07       0.04       0.04       0.02       0.02  
 
                   
Non-GAAP earnings per share
    $ 1.68       $ 1.91       $ 1.96       $ 1.07       $ 1.10  
 
                   
 
                                       
Weighted average shares - Diluted***
    40,373       42,000       42,000       42,000       42,000  
 
                   
* Effective Tax Rate of ~49% applied to GAAP earnings and ~40% applied to Non-GAAP adjustments
** GAAP earnings per share calculated on consolidated net income
*** 2010 weighted average shares shown as pre “if-converted” method

 


 

Reconciliation of Non-GAAP Information
Management uses certain Non-GAAP financial measures such as Non-GAAP earnings per share, which exclude non-cash stock-based compensation, certain intellectual property litigation expenses, amortization of intangible assets, acquisition related items, and the reversal of an income tax valuation allowance. 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.

Reconciliation of Fourth Quarter 2010 Results
                                 
                    Earnings Per Share
                    Pre “If   Post “If
    Pre-Tax           Converted”   Converted”
(in thousands, except per share data)   adjustments   Net of Tax   Method   Method
GAAP net income *
            $ 61,932       $ 1.53       $ 1.39  
Non-cash stock-based compensation
    6,921       6,641       0.16       0.15  
Certain intellectual property litigation expenses
    1,549       1,486       0.04       0.03  
Amortization of intangible assets
    1,360       1,305       0.03       0.03  
Acquisition related items
    1,440       1,382       0.03       0.03  
Reversal of remaining income tax valuation allowance
            (53,425 )     (1.32 )     (1.17 )
 
                   
Non-GAAP earnings
            $ 19,321       $ 0.48       $ 0.46  
 
                   
Weighted average shares - Diluted
                    40,347       45,488  
 
                       
* “if-converted” method assumes add back of $1.5M net of tax ($1.7M pretax) of interest and debt issuance costs to GAAP net income

Reconciliation of Full Year 2010 Results
                                 
                    Earnings Per Share
                    Pre “If   Post “If
    Pre-Tax           Converted”   Converted”
(in thousands, except per share data)   adjustments   Net of Tax   Method   Method
GAAP net income *
            $ 78,285       $ 1.94       $ 1.85  
Non-cash stock-based compensation
    28,225       25,815       0.64       0.57  
Certain intellectual property litigation expenses
    5,123       4,685       0.12       0.10  
Amortization of intangible assets
    5,407       4,945       0.12       0.11  
Acquisition related items
    2,982       2,727       0.07       0.06  
Reversal of remaining income tax valuation allowance
            (53,425 )     (1.32 )     (1.17 )
 
                   
Non-GAAP earnings
            $ 63,032       $ 1.56       $ 1.52  
 
                   
Weighted average shares - Diluted
                    40,373       45,514  
 
                       
* “if-converted” method assumes add back of $6.0M net of tax ($6.7M pretax) of interest and debt issuance costs to GAAP net income
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 1-877-407-9039 for domestic callers and 1-201-689-8470 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 25, 2011. In addition, a telephonic replay of the call will be available until March 9, 2011. The replay dial-in numbers are 1-877-870-5176 for domestic callers and 1-858-384-5517 for international callers. Please use replay pin number 365288.

 


 

About NuVasive
NuVasive is a medical device company focused on developing minimally disruptive surgical products and procedures for the spine. The Company is the 5th largest player in the $7.7 billion global spine market.
NuVasive’s 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: 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 platform’s lateral approach, known as eXtreme Lateral Interbody Fusion, or XLIF®, NuVasive has built an entire spine franchise. With over 65 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 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.
###

 


 

NuVasive, Inc.
Unaudited Condensed Consolidated Statement of Operations
(
in thousands, except per share data)
                                 
    Three Months Ended December 31,   Year Ended December 31,
    2010   2009   2010   2009
 
                               
Revenue
    $ 129,304       $ 106,935       $ 478,237       $ 370,340  
Cost of goods sold (excluding amortization of purchased technology)
    23,102       18,002       85,139       61,110  
 
               
Gross profit
    106,202       88,933       393,098       309,230  
 
                               
Operating expenses:
                               
Sales, marketing and administrative
    82,018       72,476       312,122       254,997  
Research and development
    11,490       10,943       43,479       37,581  
Amortization of intangible assets
    1,360       1,263       5,407       5,335  
 
               
Total operating expenses
    94,868       84,682       361,008       297,913  
 
                               
Interest and other (expense) income, net:
                               
Interest income
    193       189       760       1,507  
Interest expense
    (1,667 )     (1,676 )     (6,672 )     (7,116 )
Other (expense) income, net
    (345 )     136       (264 )     461  
 
               
Total interest and other (expense) income, net
    (1,819 )     (1,351 )     (6,176 )     (5,148 )
 
               
 
                               
Income before income taxes
    9,515       2,900       25,914       6,169  
Income tax (benefit) expense
    (52,018 )     679       (50,619 )     1,732  
 
               
Consolidated net income
    $ 61,533       $ 2,221       $ 76,533       $ 4,437  
 
               
Net loss attributable to noncontrolling interests
    $ (399 )     $ (60 )     $ (1,752 )     $ (1,371 )
 
               
Net income attributable to NuVasive, Inc.
    $ 61,932       $ 2,281       $ 78,285       $ 5,808  
 
               
 
                               
Net income per share attributable to NuVasive, Inc.:
                               
Basic
    $ 1.57       $ 0.06       $ 1.99       $ 0.16  
 
               
Diluted
    $ 1.39       $ 0.06       $ 1.85       $ 0.15  
 
               
Weighted average shares outstanding:
                               
Basic
    39,486       38,645       39,251       37,426  
 
               
Diluted
    45,488       39,813       45,514       38,751  
 
               
 
                               
Stock-based compensation is included in operating expenses in the following categories:
                       
Sales, marketing and administrative
    $ 6,099       $ 4,800       $ 24,945       $ 19,549  
Research and development
    822       828       3,280       4,244  
 
               
 
    $ 6,921       $ 5,628       $ 28,225       $ 23,793  
 
               

 


 

NuVasive, Inc.
Unaudited Condensed Consolidated Balance Sheets
(
in thousands)
                 
    December 31,
    2010   2009
ASSETS
               
Current assets:
               
Cash and cash equivalents
    $ 92,597       $ 65,413  
Short-term marketable securities
    86,458       99,279  
Accounts receivable, net
    76,632       58,462  
Inventory
    107,577       90,191  
Deferred tax assets
    4,425       -    
Prepaid expenses and other current assets
    4,082       3,757  
 
       
Total current assets
    371,771       317,102  
Property and equipment, net
    102,165       82,602  
Long-term marketable securities
    50,635       39,968  
Intangible assets, net
    107,121       103,338  
Goodwill
    103,070       101,938  
Deferred tax assets, non-current
    52,033       612  
Other assets
    15,234       7,260  
 
       
Total assets
    $ 802,029       $ 652,820  
 
       
LIABILITIES AND STOCKHOLDERS’ EQUITY
               
Current liabilities:
               
Accounts payable and accrued liabilities
    $ 58,995       $ 35,636  
Accrued payroll and related expenses
    17,266       19,111  
Acquisition-related liabilities
    32,715       -    
 
       
Total current liabilities
    108,976       54,747  
Senior convertible notes
    230,000       230,000  
Long-term acquisition related liabilities
    326       30,694  
Deferred tax liabilities
    3,685       16,756  
Other long-term liabilities
    12,810       10,772  
Commitments and contingencies
               
 
               
Noncontrolling interests
    11,877       13,629  
 
               
Stockholders’ equity:
               
Common stock
    40       39  
Additional paid-in capital
    545,114       485,757  
Accumulated other comprehensive income
    616       126  
Accumulated deficit
    (111,415 )     (189,700 )
 
       
Total stockholders’ equity
    434,355       296,222  
 
       
Total liabilities and stockholders’ equity
    $ 802,029       $ 652,820  
 
       

 


 

NuVasive, Inc.
Unaudited Condensed Consolidated Statements of Cash Flows

(in thousands)
                         
    Year Ended December 31,
    2010   2009   2008
                         
Operating activities:
                       
Consolidated net income (loss)
    $ 76,533       $ 4,437     $ (27,528 )
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:
                       
Depreciation and amortization
    36,737       29,841       23,105  
Deferred income tax benefit
    (53,664 )     -         -    
In-process research and development
    -         -         20,876  
Stock-based compensation
    28,225       23,793       20,947  
Leasehold abandonment (reversal)
    -         (1,997 )     4,403  
Allowance for doubtful accounts and sales return reserve, net of write-offs
    (995 )     2,211       1,026  
Allowance for excess and obsolete inventory
    1,607       2,297       (836 )
Other non-cash adjustments
    6,299       3,359       179  
Changes in operating assets and liabilities, net of effects from acquisitions:
                       
Accounts receivable
    (16,411 )     (8,582 )     (25,152 )
Inventory
    (18,664 )     (23,133 )     (32,451 )
Prepaid expenses and other current assets
    (3,559 )     760       274  
Accounts payable and accrued liabilities
    11,596       5,932       5,098  
Accrued payroll and related expenses
    (1,877 )     7,501       5,057  
 
           
Net cash provided by (used in) operating activities
    65,827       46,419       (5,002 )
Investing activities:
                       
Cash paid for acquisitions and investments
    (973 )     (46,055 )     (41,256 )
Purchases of property and equipment
    (45,846 )     (32,878 )     (39,795 )
Purchases of marketable securities
    (203,415 )     (157,278 )     (159,186 )
Sales of marketable securities
    204,439       108,308       95,926  
Other assets
    -         -         (304 )
 
           
Net cash used in investing activities
    (45,795 )     (127,903 )     (144,615 )
Financing activities:
                       
Payments of long-term liabilities
    -         -         (300 )
Issuance of convertible debt, net of costs
    -         -         222,442  
Purchase of convertible note hedges
    -         -         (45,758 )
Sale of warrants
    -         -         31,786  
Tax benefits related to stock-based compensation awards
    186       1,902       -    
Issuance of common stock
    14,831       12,556       11,850  
Other assets
    (7,935 )     -         -    
 
           
Net cash provided by financing activities
    7,082       14,458       220,020  
Effect of exchange rate changes on cash
    70       121       -    
 
           
Increase (decrease) in cash and cash equivalents
    27,184       (66,905 )     70,403  
Cash and cash equivalents at beginning of year
    65,413       132,318       61,915  
 
           
Cash and cash equivalents at end of year
    $ 92,597       $ 65,413       $ 132,318