EX-99.1 2 a51573exv99w1.htm EX-99.1 exv99w1
Exhibit 99.1
(NUVASIVE (R) LOGO)
PRESS RELEASE
     
Contact:
Kevin C. O’Boyle
EVP & Chief Financial Officer

NuVasive, Inc.
858-909-1998
investorrelations@nuvasive.com
  Investors:
Patrick F. Williams
Vice President, Finance

NuVasive, Inc.
858-638-5511
investorrelations@nuvasive.com
 
   
 
  Media:
Jason Rando
The Ruth Group

646-536-7025
jrando@theruthgroup.com
NUVASIVE REPORTS FOURTH QUARTER AND FULL YEAR 2008 FINANCIAL RESULTS
— Fourth Quarter Revenue of $74.6 Million —
— 2008 Revenue of $250.1 Million —
— Provides 2009 Guidance —
Fourth Quarter and Full Year 2008 Highlights:
  Fourth quarter total revenue of $74.6 million; up 58.9% from the fourth quarter 2007
 
  Full year 2008 total revenue of $250.1 million; up 62.1% from the full year 2007
 
  Osteocel revenue for the second half 2008 of $10 million; exceeds prior guidance of $9 million
 
  Gross margin of 82.0% for the fourth quarter and 82.3% for the full year
 
  GAAP earnings per share was $0.10 for the fourth quarter and loss per share was $(0.77) for the full year

 


 

  Full year 2008 earnings per share of $0.10 excluding in-process research and development costs and other adjustments; exceeds prior guidance of $0.07 — $0.09
SAN DIEGO, February 25, 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 and year ended December 31, 2008.
NuVasive reported fourth quarter revenue of $74.6 million, including $5.7 million of Osteocel revenue, a 58.9% increase over the $46.9 million for the fourth quarter 2007 and an 11.5% increase over the $66.9 million for the third quarter 2008. Full year 2008 revenue was $250.1 million, a 62.1% increase over the $154.3 million reported for the full year 2007.
Gross profit for the fourth quarter 2008 was $61.1 million and gross margin was 82.0%, compared to a gross profit of $38.9 million and a gross margin of 82.9% for the fourth quarter 2007. For third quarter 2008, gross profit was $54.7 million and gross margin was 81.8%. Gross profit for the full year 2008 was $205.8 million and gross margin was 82.3%, compared to a gross profit of $126.9 million and gross margin of 82.3% for the full year 2007. Gross margin on Osteocel revenue was 44.5% for the fourth quarter 2008 and 40.7% for the full year 2008.
Total operating expenses for the fourth quarter 2008 were $57.0 million compared to $41.2 million in the fourth quarter 2007 and $77.7 million in the third quarter 2008. Full year 2008 operating expenses were $233.6 million compared to $144.2 million reported for the full year 2007. The higher operating expenses in 2008 resulted primarily from additional costs directly associated with higher revenue, infrastructure expansion, and in-process research and development.
On a GAAP basis, the Company reported net income of $3.7 million or $0.10 per share for the fourth quarter 2008, and a loss of $27.5 million or $(0.77) per share for the full year 2008. On a non-GAAP basis, the Company reported net income of $12.5 million, or $0.33 per share, for the fourth quarter 2008, and net income of $27.7 million, or $0.74 per share, for the full year 2008. The non-GAAP earnings per share calculations exclude for the fourth quarter and full year, respectively, (i) stock based compensation of $5.2 million and $20.9 million; (ii) charges related to transitional support costs for the Company’s ERP system of $1.4 million and $4.0 million; (iii) amortization of acquired intangible assets of $1.2 million and $3.0 million; and (iv) intellectual property litigation expenses of $1.0 million and $1.5 million. The non-GAAP earnings per share calculations also exclude for the full year: (i) charges for in-process research and development costs of $20.9 million; and (ii) a one-time leasehold charge of $4.8 million related to vacating the Company’s previous headquarters.
Cash, cash equivalents and short and long-term marketable securities were $223.4 million at December 31, 2008.
On January 18, 2009, the Company completed an investment in Progentix Orthobiology BV. Through this investment, Progentix will continue development work on a synthetic bone substitute that has the potential to accelerate bone healing through a novel micro-structure created by a proprietary manufacturing process.
Alex Lukianov, Chairman and Chief Executive Officer, said, “We are very pleased with the Company’s continued revenue growth in 2008, in conjunction with expanding profitability. We also successfully launched several new products which strengthened our position as the leader in Maximum Access Surgery through our innovative lateral approach.”

 


 

Mr. Lukianov continued, “The Osteocel and Progentix transactions strongly position us to compete in the $1.5 billion biologics market as we seek to grow the product line to over $100 million in the next few years. Despite uncertain economic conditions, we see 2009 as an opportunity for NuVasive to continue taking market share with the speed and creativity that we have become known for. To that end, we plan to aggressively invest in the growth of our business in 2009, including the initiation of our XLTDR clinical study, increased scientific and marketing investments in our biologics platform, continued international expansion, and the launch of fifteen new products and line extensions. We look forward to capitalizing on current market conditions to accelerate our move into the top tier of global spine companies.”
2009 Financial Guidance
Full Year 2009:
     
Revenue:
  $345 million to $350 million
GAAP EPS:
  $(0.14) to $(0.12)
Non-GAAP EPS:
  $0.83 to $0.85
 
   
Non-GAAP Operating Income %:
  11% to 13%
Earnings per share of $0.02 to $0.04; adjusted for IP litigation and acquisition related costs per the enclosed table
First Quarter 2009:
     
Revenue:
  approximately $75 million
GAAP EPS:
  $(0.27) to $(0.25)
Non-GAAP EPS:
  $0.01 to $0.03
 
   
Non-GAAP Operating Income
  %: 3% to 4%
Loss per share of $(0.21) to $(0.19); adjusted for IP litigation and acquisition related costs per the enclosed table
Reconciliation of Non-GAAP Information
Management uses certain non-GAAP financial measures such as non-GAAP earnings per share, which exclude stock based compensation and charges directly related to acquisition transactions such as in-process research and development, milestone payments, amortization of the acquired intangible assets and certain other charges plus additional items in certain periods. In 2008, these charges include in-process research and development, a one-time charge related to vacating the Company’s previous headquarters, amortization of acquired intangible assets, transitional support costs for the Company’s ERP system, and intellectual property litigation expenses. In 2009, these charges include acquisition related costs, amortization of acquired intangible assets and intellectual property litigation expenses. 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 2008 Results
                 
(in thousands, except per share amounts)   $     Per Share  
GAAP net income (A)
  $ 3,700       0.10  
In-process research and development (IPR&D) (B)
           
Other adjustments (C)
    2,417       0.06  
 
           
Earnings excluding IPR&D and other adjustments
    6,117       0.16  
Non-cash stock-based compensation
    5,228       0.14  
Amortization of acquired intangible assets
    1,174       0.03  
 
           
Non-GAAP earnings (A)
  $ 12,519       0.33  
 
           
Shares used in computing GAAP earnings / (loss) per share
            36,207  
 
             
Shares used in computing non-GAAP earnings / (loss) per share
            37,744  
 
             
Reconciliation of Full Year 2008 Results
                 
(in thousands, except per share amounts)   $     Per Share  
GAAP net income (loss) (A)
  $ (27,528 )   $ (0.77 )
In-process research and development (IPR&D) (B)
    20,876       0.56  
Other adjustments (D)
    10,408       0.28  
 
           
Earnings excluding IPR&D and other adjustments
    3,756       0.10  
Non-cash stock-based compensation
    20,947       0.56  
Amortization of acquired intangible assets
    2,989       0.08  
 
           
Non-GAAP earnings (A)
  $ 27,692     $ 0.74  
 
           
Shares used in computing GAAP earnings / (loss) per share
            35,807  
 
             
Shares used in computing non-GAAP earnings / (loss) per share
            37,560  
 
             

 


 

 
A—   GAAP loss per share is calculated using basic weighted shares outstanding; GAAP earnings per share is calculated using diluted weighted shares outstanding; Non-GAAP earnings per share is calculated using diluted weighted shares outstanding.
 
B—   Charges related to the acquisition of the pedicle screw technology in the first quarter of 2008 and the acquisition of the Osteocel Business Unit in the third quarter of 2008.
 
C—   Other adjustments related to transitional support costs of $1.4 million related to the Company’s ERP system and $1.0 million for intellectual property litigation expenses.
 
D—   Other adjustments related to the one-time leasehold termination charge of $4.8 million, transitional support costs of $4.0 million related to the Company’s ERP system and $1.5 million for intellectual property litigation expenses.

 


 

Reconciliation of Full Year 2009 Guidance
                 
    Range for Quarter Ending  
    March 31, 2009  
(in thousands, except per share amounts)   Low     High  
GAAP net loss per share (A)
  $ (0.27 )   $ (0.25 )
IP Litigation costs
    0.03       0.03  
Acquisition related costs
    0.03       0.03  
     
Earnings per share excluding other adjustments
    (0.21 )     (0.19 )
Non-cash stock-based compensation
    0.19       0.19  
Amortization of acquired intangible assets
    0.03       0.03  
     
Non-GAAP earnings per share (A)
  $ 0.01     $ 0.03  
     
Shares used in computing GAAP earnings / (loss) per share
    36,400       36,400  
     
Shares used in computing non-GAAP earnings / (loss) per share
    38,400       38,400  
     
                 
    Range for Year Ending  
    December 31, 2009  
(in thousands, except per share amounts)   Low     High  
GAAP net loss per share (A)
  $ (0.14 )   $ (0.12 )
IP Litigation costs
    0.13       0.13  
Acquisition related costs
    0.03       0.03  
     
Earnings per share excluding other adjustments
    0.02       0.04  
Non-cash stock-based compensation
    0.69       0.69  
Amortization of acquired intangible assets
    0.12       0.12  
     
Non-GAAP earnings per share (A)
  $ 0.83     $ 0.85  
     
Shares used in computing GAAP earnings / (loss) per share
    37,400       37,400  
     
Shares used in computing non-GAAP earnings / (loss) per share
    39,300       39,300  
     
 
A—   GAAP loss per share is calculated using basic weighted shares outstanding; Non-GAAP earnings per share is calculated using diluted weighted shares outstanding.

 


 

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 on applications in the over $4.6 billion U.S. spine fusion market. The Company’s current principal product offering includes a minimally disruptive surgical platform called Maximum Access Surgery, or MAS®, as well as a growing offering of biologics, cervical and motion preservation products.
The MAS platform offers advantages for both patients and surgeons such as reduced surgery and hospitalization time and faster recovery. MAS combines four categories of current product offerings: NeuroVision® a proprietary software-driven nerve avoidance system; MaXcess® a unique split-blade design retraction system; biologics; and specialized implants, like SpheRx® and CoRoent®, that collectively minimize soft tissue disruption during spine surgery while allowing maximum visibility and surgical reproducibility. NuVasive’s product offering is also focused on cervical internal fixation products and its R&D pipeline emphasizes both MAS and motion preservation. NuVasive’s Biologic product portfolio includes FormaGraft®, Osteocel Plus®, and the Progentix® products, all of which are intended to facilitate fusion and complement the core fixation products.
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 uncertain process of seeking regulatory approval or clearance for NuVasive’s products or devices, including risks that such process could be significantly delayed; the risk that the Company may not be successful in integrating acquired technology or products, such as the Progentix family of products; the possibility that the FDA may require significant changes to NuVasive’s products or clinical studies; 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 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     Year Ended  
    December 31,     December 31,  
    2008     2007     2008     2007  
 
                               
Revenue
  $ 74,581     $ 46,930     $ 250,082     $ 154,290  
Cost of goods sold
    13,456       8,040       44,301       27,382  
 
                       
Gross profit
    61,125       38,890       205,781       126,908  
Operating expenses:
                               
Sales, marketing and administrative
    50,847       34,567       186,822       119,579  
Research and development
    6,146       6,667       25,943       24,581  
In-process research and development
                20,876        
 
                       
Total operating expenses
    56,993       41,234       233,641       144,160  
Interest and other income, net
    (432 )     1,198       332       5,987  
 
                       
Net income/(loss)
  $ 3,700     $ (1,146 )   $ (27,528 )   $ (11,265 )
 
                       
Net income/(loss) per share:
                               
Basic and diluted
  $ 0.10     $ (0.03 )   $ (0.77 )   $ (0.32 )
 
                       
Weighted-average shares — basic
    36,207       35,207       35,807       34,782  
 
                       
Weighted-average shares — diluted
    37,744       35,207       35,807       34,782  
 
                       

 


 

NuVasive, Inc.
Unaudited Condensed Consolidated Balance Sheets
(
in thousands, except par value)
                 
    December 31,  
    2008     2007  
ASSETS
               
Current assets:
               
Cash and cash equivalents
  $ 132,318     $ 61,915  
Short-term marketable securities
    45,738       19,247  
Accounts receivable, net of allowance of $1,952 and $926, respectively
    51,622       27,496  
Inventory, net
    68,834       36,280  
Prepaid expenses and other current assets
    3,466       1,240  
 
           
Total current assets
    301,978       146,178  
Property and equipment, net
    73,686       43,538  
Long-term marketable securities
    45,305       8,536  
Intangible assets, net
    57,099       24,496  
Other assets
    9,338       2,939  
 
           
Total assets
  $ 487,406     $ 225,687  
 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY
               
Current liabilities:
               
Accounts payable and accrued liabilities
  $ 26,633     $ 13,839  
Royalties payable
    1,722       2,076  
Accrued payroll and related expenses
    17,132       12,075  
 
           
Total current liabilities
    45,487       27,990  
Senior convertible notes
    230,000        
Other long-term liabilities
    24,288       1,119  
Commitments and contingencies Stockholders’ equity:
               
Common stock, $0.001 par value; 70,000 shares authorized 36,310 and 35,330 issued and outstanding at December 31, 2008 and 2007, respectively
    36       35  
Additional paid-in capital
    383,293       364,469  
Accumulated other comprehensive (loss) income
    (190 )     54  
Accumulated deficit
    (195,508 )     (167,980 )
 
           
Total stockholders’ equity
    187,631       196,578  
 
           
Total liabilities and stockholders’ equity
  $ 487,406     $ 225,687  
 
           

 


 

NuVasive, Inc.
Unaudited Condensed Consolidated Statements of Cash Flows

(in thousands)
                         
    Years Ended December 31,  
    2008     2007     2006  
Operating activities:
                       
Net loss
  $ (27,528 )   $ (11,265 )   $ (47,910 )
Adjustments to reconcile net loss to net cash used in operating activities:
                       
Depreciation and amortization
    23,105       12,952       8,350  
In-process research and development
    20,876              
Stock-based compensation
    20,947       13,621       13,345  
Leasehold abandonment
    4,403              
NeoDisc technology costs
                8,060  
Allowance for doubtful accounts
    1,026       189       125  
Allowance for excess and obsolete inventory
    (836 )     514       1,768  
Other
    179       109       388  
Changes in operating assets and liabilities:
                       
Accounts receivable
    (25,152 )     (8,725 )     (7,423 )
Inventory
    (32,451 )     (18,026 )     (8,877 )
Prepaid expenses and other current assets
    274       349       (220 )
Accounts payable and accrued liabilities
    5,098       5,719       3,987  
Accrued payroll and related expenses
    5,057       3,676       2,802  
 
                 
Net cash used in operating activities
    (5,002 )     (887 )     (25,605 )
Investing activities:
                       
Cash paid for acquisitions
    (41,256 )     (6,970 )      
Purchases of property and equipment
    (39,795 )     (24,403 )     (20,396 )
Purchases of short-term marketable securities
    (90,150 )     (75,135 )     (130,510 )
Sales of short-term marketable securities
    63,659       129,818       63,525  
Purchases of long-term marketable securities
    (69,036 )     (23,540 )     (1,996 )
Sales of long-term marketable securities
    32,267       17,000        
Other assets
    (304 )     (2,483 )     (452 )
 
                 
Net cash (used in) provided by investing activities
    (144,615 )     14,287       (89,829 )
Financing activities:
                       
Payments of long-term liabilities
    (300 )     (300 )     (300 )
Issuance of convertible debt, net of costs
    222,442              
Purchase of convertible note hedges
    (45,758 )            
Sale of warrants
    31,786              
Issuance of common stock
    11,850       7,339       144,665  
 
                 
Net cash provided by financing activities
    220,020       7,039       144,365  
 
                 
Increase in cash and cash equivalents
    70,403       20,439       28,931  
Cash and cash equivalents at beginning of year
    61,915       41,476       12,545  
 
                 
Cash and cash equivalents at end of year
  $ 132,318     $ 61,915     $ 41,476  
 
                 
Supplemental disclosure of non-cash transactions:
                       
Landlord paid tenant improvements
  $ 7,309     $     $  
 
                 
Issuance of common stock for NeoDisc technology costs
  $     $     $ 8,060  
 
                 
Issuance of common stock in connection with acquisitions
  $     $ 10,501     $