Attached files

file filename
8-K - FORM 8-K - NUVASIVE INCa59413e8vk.htm

Exhibit 99.1
(NUVASIVE LOGO)
PRESS RELEASE
     
Contact:
  Investors:
Michael J. Lambert
  Patrick F. Williams
EVP & Chief Financial Officer
  Vice President, Industry & 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 FIRST QUARTER 2011
FINANCIAL RESULTS
   
Total revenue of $124.5 million, up 14.1% over first quarter 2010
 
   
GAAP earnings of $2.4 million, or $0.06 per share, includes the benefit of a change in accounting estimate of $0.02 per share
 
   
Non-GAAP earnings of $9.5 million, or $0.24 per share, includes the benefit of a change in accounting estimate of $0.02 per share
 
   
Non-GAAP operating margin of 13.3% and GAAP operating margin of 3.7%, both include the benefit of a change in accounting estimate of 1.4%
 
   
Operating cash flow of $14.5 million
SAN DIEGO, May 4, 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 ended March 31, 2011.

 


 

NuVasive reported first quarter 2011 revenue of $124.5 million, a 14.1% increase over the $109.1 million for the first quarter 2010 and a 3.7% decrease compared to $129.3 million for the fourth quarter 2010. The sequential deceleration was driven in part by the recognition of approximately $4.0 million in seasonal capital purchases and for back royalties related to a settlement in the fourth quarter 2010.
The financial results announced today reflect a change in accounting estimate for the useful life of certain loaned instrument sets placed into service prior to January 1, 2011. After a thorough review of its available history, the Company concluded that a four year useful life estimate is a more accurate assessment of the economic life of these fixed assets. Under existing accounting literature, this type of change is only adjusted prospectively in the financial statements.
Gross profit for the first quarter 2011 was $100.9 million and gross margin was 81.1%, compared to a gross profit of $89.6 million and a gross margin of 82.2% for the first quarter 2010. For the fourth quarter 2010, gross profit was $106.2 million and gross margin was 82.1%.
Total operating expenses for the first quarter 2011 were $96.3 million compared to $86.7 million in the first quarter 2010 and $94.9 million in the fourth quarter 2010. The higher operating expenses in the first quarter 2011 resulted primarily from additional costs associated with higher revenue and infrastructure expansion.
On a GAAP basis, the Company reported net income of $2.4 million, or $0.06 per share, for the first quarter 2011.
On a Non-GAAP basis, the Company reported net income of $9.5 million, or $0.24 per share, for the first quarter 2011. The Non-GAAP earnings per share calculations for the first quarter exclude (i) non-cash stock-based compensation of $7.9 million; (ii) certain intellectual property litigation expenses of $2.1 million; (iii) amortization of intangible assets of $1.3 million; and (iv) acquisition related items of $571 thousand.
Cash, cash equivalents and short and long-term marketable securities were $225.8 million at March 31, 2011.
Alex Lukianov, Chairman and Chief Executive Officer, said, “Our financial performance in the first quarter of 2011 was excellent across all our key sectors. We generated revenue growth of over 14% and better than expected operating margin improvement, in view of challenging spine market growth dynamics. Our performance internationally was a highlight, and is well on track to double this year to approximately 8% of revenue. We are pleased to be able to raise revenue guidance today in light of a marginally improved outlook for our U.S. lumbar business this year. As our focus shifts 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 expect to continue to sustain industry leading growth.”

 


 

2011 Full Year Financial Guidance
   
Revenue of $530 million to $540 million; up from previous guidance of $525 million to $535 million
 
   
GAAP EPS of $0.52 to $0.55; up from previous guidance of $0.39 to $0.42
 
   
Non-GAAP EPS of $1.20 to $1.23; up from previous guidance of $1.07 to $1.10
 
   
Non-GAAP Operating Margin of ~17.5%, up from previous guidance of ~16.5%
 
   
GAAP effective tax rate of ~45%, down from previous guidance of ~49%
2011 Non-GAAP Earnings Per Share Full Year Guidance Bridge
                                                 
 
                               
                        Change in     GAAP            
      Prior       Revenue     Accounting     Tax Rate       Revised    
      Guidance       Increase     Estimate     Decrease       Guidance    
                                                 
Low Range
    $ 1.07       $ 0.01     $ 0.08     $ 0.04       $ 1.20    
High Range
    $ 1.10       $ 0.01     $ 0.08     $ 0.04       $ 1.23    
 
                               
Reconciliation of Full Year EPS Guidance
                                          
                   
    2010     2011     2011  
    Pre Tax     Pre Tax     Net of Tax*  
                   
    Actual     Low Range     High Range     Low Range     High Range  
GAAP earnings per share**
    $ 0.64       $ 0.94       $ 1.00       $ 0.52       $ 0.55  
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       $ 2.07       $ 2.13       $ 1.20       $ 1.23  
 
                   
 
                                       
Weighted shares outstanding - Diluted***
    40,373       42,000       42,000       42,000       42,000  
 
                   
* Effective Tax Rate of ~45% applied to GAAP earnings and ~40% applied to Non-GAAP adjustments
** GAAP earnings per share calculated based on consolidated net income
*** 2010 weighted shares outstanding shown as pre “if-converted” method

 


 

2011 Guidance Reconciliation of Non-GAAP Operating Margin %
                             
                 
              FY 11  
    FY 10     Estimate  
    Actual     Prior   Revised  
         
 
 
 
 
Gross Margin % [A]
    82.2%         ~ 81%       ~ 81%    
 
                           
Non-GAAP Research and Development [B]
    8.0%         ~ 8%       ~ 8%    
         
Non-cash stock-based compensation
    0.7%         ~ 1%       ~ 1%    
         
Acquisition related items*
    0.4%       as incurred   as incurred  
         
 
 
 
 
         
GAAP research and development
    9.1%         ~ 9%       ~ 9%    
 
                           
Non-GAAP Sales, Marketing and Administrative [C]
    58.8%         ~ 56.5%       ~ 55.5%    
 
                           
Non-cash stock-based compensation
    5.2%         ~ 5%       ~ 5%    
 
                           
Certain intellectual property litigation expenses
    1.1%         ~ 1%       ~ 1%    
 
                           
Acquisition related items*
    0.2%       ~ 0.5% & as incurred   ~ 0.5% & as incurred  
         
 
 
 
 
 
                           
GAAP sales, marketing and administrative
    65.3%         ~ 63%       ~ 62%    
 
                           
Amortization of intangible assets
    1.1%         ~ 1.5%       ~ 1.5%    
 
                           
                 
Non-GAAP Operating Margin % [A-B-C]
    15.4%         ~ 16.5%       ~ 17.5%    
                 
* Acquisition related items include ~0.5% of revenue for expenses associated with prior M&A activity and as incurred
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, and acquisition related items. 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 First Quarter 2011 Results
                         
    Pre-Tax           Earnings
(in thousands, except per share data)   adjustments   Net of Tax   Per Share
GAAP net income
            $ 2,359       $ 0.06  
Non-cash stock-based compensation
    $ 7,946       4,768       0.12  
Certain intellectual property litigation expenses
    2,081       1,249       0.03  
Amortization of intangible assets
    1,342       805       0.02  
Acquisition related items
    571       343       0.01  
 
               
Non-GAAP earnings
            $ 9,524       $ 0.24  
 
               
Weighted shares outstanding - Diluted
                    40,511  
 
                   
 

 


 

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 June 3, 2011. In addition, a telephonic replay of the call will be available until May 18, 2011. The replay dial-in numbers are 1-877-870-5176 for domestic callers and 1-858-384-5517 for international callers. Please use pin number 369959.
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 March 31,
    2011   2010
 
Revenue
    $ 124,466       $ 109,087  
 
Cost of goods sold (excluding amortization of purchased technology)
    23,526       19,443  
 
       
 
Gross profit
    100,940       89,644  
 
               
Operating expenses:
               
 
Sales, marketing and administrative
    84,220       74,661  
 
Research and development
    10,769       10,699  
 
Amortization of intangible assets
    1,342       1,350  
 
 
       
 
Total operating expenses
    96,331       86,710  
 
               
Interest and other expense, net:
               
 
Interest income
    183       189  
 
Interest expense
    (1,771 )     (1,669 )
 
Other income, net
    497       117  
 
       
 
Total interest and other expense, net
    (1,091 )     (1,363 )
 
       
 
               
Income before income taxes
    3,518       1,571  
 
Income tax expense
    1,540       865  
 
       
 
Consolidated net income
    $ 1,978       $ 706  
 
       
Net loss attributable to noncontrolling interests
    $ (381 )     $ (382 )
 
       
 
Net income attributable to NuVasive, Inc.
    $ 2,359       $ 1,088  
 
       
 
               
Net income per share attributable to NuVasive, Inc.:
               
 
Basic and diluted
    $ 0.06       $ 0.03  
 
       
 
Weighted average shares outstanding:
               
 
Basic
    39,616       38,898  
 
       
Diluted
    40,511       40,061  
 
 
       
 
               
Stock-based compensation is included in operating expenses in the following categories:
               
 
Sales, marketing and administrative
    $ 7,335       $ 5,680  
 
Research and development
    611       754  
 
       
 
    $ 7,946       $ 6,434  
 
       

 


 

NuVasive, Inc.
Unaudited Condensed Consolidated Balance Sheets
(
in thousands)
                 
    March 31, 2011   December 31, 2010
    (Unaudited)        
 
ASSETS
               
 
Current assets:
               
 
Cash and cash equivalents
    $ 134,101       $ 92,597  
 
Short-term marketable securities
    58,876       86,458  
 
Accounts receivable, net
    75,952       76,632  
 
Inventory
    114,388       107,577  
 
Deferred tax assets
    4,425       4,425  
 
Prepaid expenses and other current assets
    4,750       4,082  
 
 
       
Total current assets
    392,492       371,771  
 
Property and equipment, net
    105,066       102,165  
 
Long-term marketable securities
    32,814       50,635  
 
Intangible assets, net
    105,817       107,121  
 
Goodwill
    103,070       103,070  
Deferred tax assets, non-current
    52,033       52,033  
 
Other assets
    15,438       15,234  
 
       
Total assets
    $ 806,730       $ 802,029  
 
       
LIABILITIES AND STOCKHOLDERS’ EQUITY
               
 
Current liabilities:
               
 
Accounts payable and accrued liabilities
    $ 54,899       $ 58,995  
 
Accrued payroll and related expenses
    14,643       17,266  
 
Acquisition-related liabilities
    33,155       32,715  
 
 
       
Total current liabilities
    102,697       108,976  
 
Senior convertible notes
    230,000       230,000  
 
Long-term acquisition-related liabilities
    339       326  
 
Deferred tax liabilities
    3,685       3,685  
 
Other long-term liabilities
    12,729       12,810  
 
Commitments and contingencies
               
 
               
 
Noncontrolling interests
    11,496       11,877  
 
               
Stockholders’ equity:
               
 
Common stock
    40       40  
 
Additional paid-in capital
    553,484       545,114  
 
Accumulated other comprehensive income
    1,316       616  
 
Accumulated deficit
    (109,056 )     (111,415 )
 
       
Total stockholders’ equity
    445,784       434,355  
 
       
 
Total liabilities and stockholders’ equity
    $ 806,730       $ 802,029  
 
       

 


 

NuVasive, Inc.
Unaudited Condensed Consolidated Statements of Cash Flows

(in thousands)
                 
    Three Months Ended March 31,
    2011   2010
 
Operating activities:
               
 
Consolidated net income
    $ 1,978       $ 706  
 
Adjustments to reconcile net income to net cash provided by operating activities:
               
 
Depreciation and amortization
    7,781       8,104  
 
Stock-based compensation
    7,946       6,434  
 
Allowance for excess and obsolete inventory
    216       736  
 
Allowance for doubtful accounts and sales return reserve, net of write-offs
    6       (657 )
 
Other non-cash adjustments
    1,795       1,454  
 
Changes in operating assets and liabilities, net of effects from acquisitions:
               
 
Accounts receivable
    942       (3,100 )
 
Inventory
    (6,658 )     (1,237 )
 
Prepaid expenses and other current assets
    (751 )     (1,570 )
 
Accounts payable and accrued liabilities
    3,959       4,780  
 
Accrued payroll and related expenses
    (2,670 )     (6,512 )
 
       
Net cash provided by operating activities
    14,544       9,138  
 
Investing activities:
               
 
Purchases of property and equipment
    (10,000 )     (8,402 )
 
Purchases of marketable securities
    (26,018 )     (45,525 )
 
Sales of marketable securities
    71,185       54,016  
 
Payment for specific rights in connection with supply agreement
    (8,000 )     -      
 
       
Net cash provided by investing activities
    27,167       89  
 
Financing activities:
               
 
Issuance of common stock
    425       6,628  
 
Other assets
    (709 )     (4,408 )
 
Tax benefits related to stock-based compensation awards
    -           882  
 
 
       
Net cash (used in) provided by financing activities
    (284 )     3,102  
 
Effect of exchange rate changes on cash
    77       (78 )
 
       
Increase in cash and cash equivalents
    41,504       12,251  
 
Cash and cash equivalents at beginning of period
    92,597       65,413  
 
       
Cash and cash equivalents at end of period
    $ 134,101       $ 77,664