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8-K - FORM 8-K - NUVASIVE INCa54063e8vk.htm
Exhibit 99.1
(NUVASIVE LOGO)
PRESS RELEASE
     
Contact:
  Investors:
Kevin C. O’Boyle
  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:
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 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 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 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 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 Company’s 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’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: 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 platform’s 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 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 the Company’s 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 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 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)
                 
    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)
                 
    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