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8-K - FORM 8-K - NUVASIVE INCd247327d8k.htm

Exhibit 99.1

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:

Nicholas S. Laudico

The Ruth Group

646-536-7030

nlaudico@theruthgroup.com

NUVASIVE REPORTS THIRD QUARTER 2011

FINANCIAL RESULTS

 

   

Total revenue of $132.9 million, up 10.5% over third quarter 2010

 

   

GAAP loss of $67.6 million, or $1.69 per share

 

   

Non-GAAP earnings of $10.6 million, or $0.26 per share

 

   

Non-GAAP operating margin of 16.8%

SAN DIEGO, October 27, 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 September 30, 2011.

NuVasive reported third quarter 2011 revenue of $132.9 million, a 10.5% increase over the $120.3 million for the third quarter 2010 and in line with the $133.0 million reported for the second quarter 2011.


Gross profit for the third quarter 2011 was $106.9 million and gross margin was 80.4%, compared to a gross profit of $98.7 million and a gross margin of 82.1% for the third quarter 2010. For the second quarter 2011, gross profit was $107.5 million and gross margin was 80.8%.

Total operating expenses for the third quarter 2011 were $198.3 million compared to $89.1 million in the third quarter 2010 and $96.0 million in the second quarter 2011. The higher operating expenses in the third quarter 2011 compared to the prior year resulted primarily from a charge related to a litigation liability and additional costs associated with higher revenue and infrastructure expansion.

On a GAAP basis, the Company reported a net loss of $67.6 million, or $1.69 per share, for the third quarter 2011.

On a Non-GAAP basis, the Company reported net income of $10.6 million, or $0.26 per share, for the third quarter 2011. The Non-GAAP earnings per share calculations for the third quarter exclude (i) non-cash stock-based compensation of $8.1 million; (ii) certain intellectual property litigation expenses of $103.7 million; (iii) amortization of intangible assets of $1.5 million; (iv) acquisition related items of $441 thousand; (vi) non-cash interest expense on convertible notes of $3.0 million; (vii) a positive impact from certain transactions associated with convertible notes activity of $1.7 million; and (viii) certain discrete tax items of $6.3 million.

Cash, cash equivalents and short and long-term marketable securities were $418.9 million at September 30, 2011.

Alex Lukianov, Chairman and Chief Executive Officer, said, “Our financial performance in the third quarter of 2011 attests to exceptional execution by the NuVasive team. In the face of an extremely challenging spine market, we delivered industry leading growth and executed a strategic transaction that will enhance the penetration of XLIF and NeuroVision for years to come. Our Impulse Monitoring acquisition increases our Intra-Operative Monitoring platform, allowing us to offer surgeons and hospitals complete procedural solutions in all areas of spine. With Speed of Innovation driving our market share taking strategy, we will continue to remain laser focused on pushing toward our next milestone of being a $1 billion company with increasing profitability to serve the needs of spine surgery patients.”

Revised 2011 Full Year Financial Guidance

 

   

Revenue of $538 million to $540 million, compared to previous guidance of $530 million to $540 million

 

   

GAAP loss per share of $1.43 to $1.42, compared to previous guidance for GAAP earnings per share of $0.33 to $0.36

 

   

Non-GAAP EPS of $1.01 to $1.02, compared to previous guidance for $1.09 to $1.12

 

   

Non-GAAP Operating Margin of ~15.5%, compared to previous guidance of ~17.5%

 

   

GAAP effective tax benefit rate of ~27%, compared to previous guidance for a GAAP effective tax expense rate of ~50%

 

2


Reconciliation of Full Year EPS Guidance

 

    2010
Pre-Tax
        

2011

Pre-Tax

        

2011

Net of Tax (1)

 
      Actual            Low
  Range  
    High
  Range  
         Low
  Range  
    High
  Range  
 

GAAP earnings (loss) per share guidance

    $ 0.64            $ (1.94)        $ (1.93)           $ (1.43)        $ (1.42)   

Impact of change from basic to diluted share count 2

    -               0.09         0.09            0.07         0.07    
 

 

 

      

 

 

      

 

 

 

GAAP earnings (loss) per share guidance adjusted to diluted share count

    $ 0.64            $ (1.85)        $ (1.84)           $ (1.36)        $ (1.35)   

Non-cash stock based compensation

    0.70            0.75         0.75            0.47         0.47    

Certain intellectual property litigation expenses 3

    0.13            2.53         2.53            1.56         1.56    

Amortization of intangible assets

    0.13            0.15         0.15            0.09         0.09    

Acquisition related items

    0.07            0.05         0.05            0.03         0.03    

Non-cash interest expense on convertible notes

    -               0.14         0.14            0.09         0.09    

Certain transactions associated with convertible notes activity

    -               (0.04)        (0.04)           (0.02)        (0.02)   

Certain discrete tax items

    -               0.15         0.15            0.15         0.15    
 

 

 

      

 

 

      

 

 

 

Non-GAAP earnings per share guidance

    $ 1.68            $ 1.88         $ 1.89            $ 1.01         $ 1.02    
 

 

 

      

 

 

      

 

 

 

Weighted shares outstanding - basic 4

         40,600         40,600            40,600         40,600    
      

 

 

      

 

 

 

Weighted shares outstanding - diluted 4

    40,373            42,600         42,600            42,600         42,600    
 

 

 

      

 

 

      

 

 

 

 

  1 

Effective tax benefit rate of ~27% applied to GAAP earnings and ~38% applied to Non-GAAP adjustments

  2 

GAAP loss for 2011 utilizes the “basic” weighted shares outstanding when calculating earnings per share. However, Non-GAAP earnings are positive requiring the use of the “diluted” weighted share count when calculating earnings per share. This line represents the impact of the change from “basic” to “diluted” weighted shares on GAAP earnings per share calculation to reconcile down to Non-GAAP earnings per share computed using the diluted weighted shares outstanding.

  3 

Includes a charge for the litigation liability of $101.2 million

  4 

Weighted shares outstanding shown as pre “if-converted” method

 

3


2011 Full Year EPS Guidance Bridge

 

    Net of Tax  
        Low                  High      

Prior GAAP earnings per share guidance

  $ 0.33          $ 0.36    

Impact of change from diluted to basic share count 1

    0.01            0.01    
 

 

 

      

 

 

 

GAAP earnings per share adjusted to basic share count

  $ 0.34          $ 0.37    

Repurchase of $118.7 million of 2013 convertible notes

    0.01            0.01    

Litigation liability

    (1.56)           (1.56)   

Medtronic ongoing royalty

    (0.06)           (0.06)   

Certain transactions associated with convertible notes activity

    0.04            0.04    

Certain discrete tax items

    (0.16)           (0.16)   

Acquisition of Impulse Monitoring

    -               -       

Change in underlying business revenue and expenses

    (0.05)           (0.08)   

Impact of change in tax rate 2

    0.01            0.02    

Revised GAAP loss per share guidance

  $ (1.43)         $ (1.42)   

 

        Low                  High      

Prior Non-GAAP earnings per share guidance

  $ 1.09          $ 1.12    

Repurchase of $118.7 million of 2013 convertible notes

    0.02            0.02    

Medtronic ongoing royalty

    (0.06)           (0.06)   

Acquisition of Impulse Monitoring

    (0.01)           (0.01)   

Change in underlying business revenue and expenses

    (0.07)           (0.10)   

Impact of change in tax rate 3

    0.04            0.05    

Revised Non-GAAP earnings per share guidance

  $ 1.01          $ 1.02    

 

  1 

Prior GAAP earnings per share guidance assumed GAAP earnings which resulted in the use of “diluted” weighted shares outstanding for the earnings per share calculation. Based upon the litigation liability recognized in the third quarter, the full year will now be in a GAAP loss position, requiring the use of “basic” weighted shares outstanding in the loss per share calculation. This line recognizes the impact of the change from using “diluted” to “basic” weighted shares outstanding on the prior guidance.

 
  2 

New effective GAAP tax benefit rate of ~27%, down from previous guidance of ~50%.

 
  3 

New effective Non-GAAP tax rate of ~38% for Non-GAAP adjustments, down from previous guidance of ~40%.

 

 

 

4


 

2011 Guidance Reconciliation of Non-GAAP Operating Margin %

 

         FY 10         Estimate
             Actual             Prior         Revised
Gross Margin % [A]      82.2%       ~81%       ~79.5%
Non-GAAP Research and Development [B]      8.0%       ~7%       ~7%
Non-cash stock-based compensation      0.7%       ~1%       ~0.5%
Acquisition related items*      0.4%       as incurred         ~ 0.1% & as incurred  
GAAP research and development      9.1%       ~8%       ~7.6%
Non-GAAP Sales, Marketing and Administrative [C]      58.8%       ~56.5%       ~57%
Non-cash stock-based compensation      5.2%       ~5%       ~5.5%
Certain intellectual property litigation expenses      1.1%       ~1%       ~1.2%
Acquisition related items*      0.2%       ~ 0.5% & as incurred       ~ 0.3% & as incurred
GAAP sales, marketing and administrative      65.3%       ~63%       ~64%
Litigation liability      -         -         ~18.7%
Amortization of intangible assets      1.1%       ~1.5%       ~1.3%
                
Non-GAAP Operating Margin % [A-B-C]      15.4%       ~17.5%       ~15.5%

  * Acquisition related items include ~0.4% 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, acquisition related items, non-cash interest expense on convertible notes, a positive impact from certain transactions associated with convertible notes activity, and certain discrete tax 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.

 

5


Reconciliation of Third Quarter 2011 Results

 

(in thousands, except per share data)

  

    Pre-Tax    

    Adjustments    

    

    Net of Tax    

    

    (Loss) Earnings    

    Per Share    

 
        

GAAP net loss

      $ (67,552)       $ (1.69)   

Impact of change from basic to diluted share count

           0.04    
     

 

 

    

 

 

 

GAAP net loss, adjusted to diluted share count

      $ (67,552)       $ (1.65)   

Non-cash stock-based compensation

   $ 8,118          5,066          0.12    

Certain intellectual property litigation expenses

     103,740          64,744          1.59    

Amortization of intangible assets

     1,504          939          0.02    

Acquisition related items

     441          275          0.01    

Non-cash interest expense on new convertible notes

     2,979          1,859          0.05    

Certain transactions associated with convertible notes activity

     (1,666)         (1,040)         (0.03)   

Certain discrete tax items

     6,316          6,316          0.15    
     

 

 

    

 

 

 

Non-GAAP earnings

      $ 10,607        $ 0.26    
     

 

 

    

 

 

 

GAAP weighted shares outstanding - basic and diluted

           39,892    
        

 

 

 

Non-GAAP weighted shares outstanding - diluted

           40,831    
        

 

 

 

 

 

Reconciliation of Year To Date 2011 Results

 

(in thousands, except per share data)

       Pre-Tax    
    Adjustments    
         Net of Tax              (Loss) Earnings    
    Per Share    
 
        
        

GAAP net loss

      $ (59,813)       $ (1.50)   

Impact of change from basic to diluted share count

           0.03    
     

 

 

    

 

 

 

GAAP net loss, adjusted to diluted share count

      $ (59,813)       $ (1.47)   

Non-cash stock-based compensation

   $ 23,789          14,749          0.36    

Certain intellectual property litigation expenses

     106,920          66,290          1.63    

Amortization of intangible assets

     4,241          2,629          0.06    

Acquisition related items

     2,337          1,449          0.04    

Non-cash interest expense on new convertible notes

     3,075          1,907          0.05    

Certain transactions associated with convertible notes activity

     (1,666)         (1,033)         (0.03)   

Certain discrete tax items

     6,316          6,316          0.16    
     

 

 

    

 

 

 

Non-GAAP earnings

      $ 32,494        $ 0.80    
     

 

 

    

 

 

 

GAAP weighted shares outstanding—basic and diluted

           39,766    
        

 

 

 

Non-GAAP weighted shares outstanding—diluted

           40,738    
        

 

 

 

 

 

6


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 November 26, 2011. In addition, a telephonic replay of the call will be available until November 10, 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 378602.

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.

###

 

7


NuVasive, Inc.

Unaudited Condensed Consolidated Statements of Operations

(in thousands, except per share data)

 

     Three Months Ended September 30,     Nine Months Ended September 30,  
     2011     2010     2011     2010  

Revenue

   $ 132,880      $ 120,262      $ 390,312      $ 348,933   

Cost of goods sold (excluding amortization of purchased technology)

     26,015        21,580        75,049        62,037   
  

 

 

   

 

 

   

 

 

   

 

 

 

Gross profit

     106,865        98,682        315,263        286,896   

Operating expenses:

        

Sales, marketing and administrative

     85,482        77,717        254,025        230,104   

Research and development

     10,092        10,085        31,119        31,989   

Amortization of intangible assets

     1,504        1,342        4,241        4,047   

Litigation award

     101,200        -          101,200        -     
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     198,278        89,144        390,585        266,140   

Interest and other expense, net:

        

Interest income

     257        200        591        567   

Interest expense

     (7,276     (1,668     (10,962     (5,005

Other income (expense), net

     1,726        (6     2,303        81   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total interest and other expense, net

     (5,293     (1,474     (8,068     (4,357
  

 

 

   

 

 

   

 

 

   

 

 

 

(Loss) income before income tax expense

     (96,706     8,064        (83,390     16,399   

Income tax (benefit) expense

     (29,031     (40     (22,715     1,399   
  

 

 

   

 

 

   

 

 

   

 

 

 

Consolidated net (loss) income

   $ (67,675   $ 8,104      $ (60,675   $ 15,000   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss attributable to noncontrolling interests

   $ (123   $ (438   $ (862   $ (1,353
  

 

 

   

 

 

   

 

 

   

 

 

 

Net (loss) income attributable to NuVasive, Inc.

   $ (67,552   $ 8,542      $ (59,813   $ 16,353   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net (loss) income per share attributable to NuVasive, Inc.:

        

Basic

   $ (1.69   $ 0.22      $ (1.50   $ 0.42   
  

 

 

   

 

 

   

 

 

   

 

 

 

Diluted

   $ (1.69   $ 0.21      $ (1.50   $ 0.40   
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average shares outstanding:

        

Basic

     39,892        39,394        39,766        39,180   
  

 

 

   

 

 

   

 

 

   

 

 

 

Diluted

     39,892        40,396        39,766        40,389   
  

 

 

   

 

 

   

 

 

   

 

 

 

Stock-based compensation is included in operating expenses in the following categories:

        

Sales, marketing and administrative

   $ 7,497      $ 6,494      $ 21,956      $ 18,846   

Research and development

     621        827        1,833        2,458   
  

 

 

   

 

 

   

 

 

   

 

 

 
   $ 8,118      $ 7,321      $ 23,789      $ 21,304   
  

 

 

   

 

 

   

 

 

   

 

 

 

 

8


NuVasive, Inc.

Condensed Consolidated Balance Sheets

(in thousands)

 

      September 30, 2011     December 31, 2010  
     (Unaudited)        

ASSETS

    

Current assets:

    

Cash and cash equivalents

   $ 220,943      $ 92,597   

Short-term marketable securities

     151,363        86,458   

Accounts receivable, net

     78,637        76,632   

Inventory

     122,588        107,577   

Deferred tax assets

     4,425        4,425   

Prepaid expenses and other current assets

     5,100        4,082   
  

 

 

   

 

 

 

Total current assets

     583,056        371,771   

Property and equipment, net

     118,125        102,165   

Long-term marketable securities

     46,593        50,635   

Intangible assets, net

     100,044        107,121   

Goodwill

     103,070        103,070   

Deferred tax assets, non-current

     76,260        52,033   

Restricted cash and investments

     68,463        5,529   

Other assets

     19,187        9,705   
  

 

 

   

 

 

 

Total assets

   $ 1,114,798      $ 802,029   
  

 

 

   

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

    

Current liabilities:

    

Accounts payable and accrued liabilities

   $ 52,191      $ 58,995   

Accrued payroll and related expenses

     17,872        17,266   

Litigation liability

     101,200        -     

Acquisition-related liabilities

     33,628        32,715   
  

 

 

   

 

 

 

Total current liabilities

     204,891        108,976   

Senior Convertible Notes

     427,974        230,000   

Long-term acquisition-related liabilities

     -          326   

Deferred tax liabilities

     3,685        3,685   

Other long-term liabilities

     13,088        12,810   

Commitments and contingencies

    

Noncontrolling interests

     11,015        11,877   

Stockholders’ equity:

    

Common stock

     40        40   

Additional paid-in capital

     625,387        545,114   

Accumulated other comprehensive income

     (54     616   

Accumulated deficit

     (171,228     (111,415
  

 

 

   

 

 

 

Total stockholders’ equity

     454,145        434,355   
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 1,114,798      $ 802,029   
  

 

 

   

 

 

 

 

9


NuVasive, Inc.

Unaudited Condensed Consolidated Statements of Cash Flows

(in thousands)

 

      Nine Months Ended September 30,  
      2011     2010  

Operating activities:

    

Consolidated net (loss) income

   $ (60,675   $ 15,000   

Adjustments to reconcile net (loss) income to net cash provided by operating activities:

    

Depreciation and amortization

     24,847        27,404   

Stock-based compensation

     23,789        21,304   

Allowance for excess and obsolete inventory

     4,642        1,682   

Allowance for doubtful accounts and sales return reserve, net of write-offs

     1,261        (1,039

Accretion of contingent consideration

     587        570   

Amortization of debt issuance costs

     2,588        1,120   

Amortization of debt discount

     3,076        —     

Gain recognized on change in fair value of derivatives

     (2,387     —     

Deferred income tax expense

     6,238        —     

Other non-cash adjustments

     3,545        2,924   

Changes in operating assets and liabilities, net of effects from acquisitions:

    

Accounts receivable

     (3,152     (11,465

Inventory

     (19,933     (10,043

Prepaid expenses and other assets

     (1,061     (3,878

Accounts payable and accrued liabilities

     504        6,502   

Litigation liability

     101,200        —     

Accrued payroll and related expenses

     584        (5,973

Income taxes payable

     (32,237     (186
  

 

 

   

 

 

 

Net cash provided by operating activities

     53,416        43,922   

Investing activities:

    

Purchases of property and equipment

     (39,435     (36,622

Purchases of marketable securities

     (244,209     (150,045

Sales of marketable securities

     124,205        142,313   

Purchases of restricted investments

     (4,535     —     

Payment for specific rights in connection with supply agreement, net of refund received

     (5,000     —     

Other assets

     (1,100     (659
  

 

 

   

 

 

 

Net cash used in investing activities

     (170,074     (45,013

Financing activities:

    

Proceeds from the sale of warrants

     47,898        —     

Proceeds from the issuance of convertible debt, net of issuance costs

     391,334        —     

Purchase of convertible note hedges

     (80,097     —     

Repurchase of 2013 Senior Convertible Notes

     (118,702     —     

Proceeds from the issuance of common stock

     4,461        12,768   

Other assets

     (349     (7,722

Tax benefits related to stock-based compensation awards

     638        1,118   
  

 

 

   

 

 

 

Net cash provided by financing activities

     245,183        6,164   
  

 

 

   

 

 

 

Effect of exchange rate changes on cash

     (179     104   
  

 

 

   

 

 

 

Increase in cash and cash equivalents

     128,346        5,177   

Cash and cash equivalents at beginning of period

     92,597        65,413   
  

 

 

   

 

 

 

Cash and cash equivalents at end of period

   $ 220,943      $ 70,590   
  

 

 

   

 

 

 

 

10