EX-99.1 2 a50225exv99w1.htm EX-99.1 exv99w1
Exhibit 99.1
(NUVASIVE LOGO)
     
PRESS RELEASE
Contact:
  Investors:
Kevin C. O’Boyle
  Nick Laudico/Zack Kubow
EVP & Chief Financial Officer
  The Ruth Group
NuVasive, Inc.
  646-536-7030/7020
858-909-1800
  nlaudico@theruthgroup.com
investorrelations@nuvasive.com
  zkubow@theruthgroup.com
 
   
 
  Media:
 
  Jason Rando
 
  The Ruth Group
 
  646-536-7025
 
  jrando@theruthgroup.com
NUVASIVE REPORTS THIRD QUARTER 2008 FINANCIAL RESULTS
- Increases 2008 Revenue Guidance to $245 Million to $247 Million -
Third Quarter 2008 Highlights:
  Total revenues of $66.9 million; up 73.7% from the third quarter of 2007
  Total revenues without Osteocel of $62.5 million; up 62.3% from the third quarter of 2007
  Gross profit of $54.7 million; up 73.2% from the third quarter of 2007
  Gross margin of 81.8% compared to 82.0% in the third quarter of 2007
  GAAP loss per share for the quarter was $(0.64)
  Non-GAAP earnings per share was $0.21
  Completed enrollment of NeoDisc® clinical trial
  Launched next generation NeuroVision® M5™, extended the line of CoRoent® interbody spacers and introduced XLIF® TDR revision instrumentation

 


 

SAN DIEGO, October 22, 2008 – 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, 2008.
NuVasive reported third quarter revenues of $66.9 million, including $4.4 million of Osteocel revenue, a 73.7% increase over the $38.5 million for the third quarter of 2007 and a 16.5% increase over the $57.4 million for the second quarter of 2008.
Gross profit for the third quarter of 2008 was $54.7 million and gross margin was 81.8%, compared to a gross profit of $31.6 million and a gross margin of 82.0% in the third quarter of 2007. For the second quarter of 2008, gross profit was $47.8 million and gross margin was 83.3%. Gross margin on Osteocel revenues was 36.4%.
Total operating expenses for the third quarter of 2008 were $77.7 million compared to $35.2 million in the third quarter of 2007 and $48.5 million in the second quarter of 2008. On a GAAP basis, the Company reported a net loss of $23.1 million or $(0.64) per share for the third quarter of 2008.
On a non-GAAP basis, the Company reported net income of $8.0 million, or $0.21 per share, for the third quarter of 2008. The non-GAAP earnings per share calculations exclude (i) stock based compensation of $5.4 million; (ii) a charge for in-process research and development costs of $16.7 million; (iii) a charge related to transitional support costs for the Company’s ERP system of $2.6 million; (iv) a one-time leasehold charge of $4.8 million related to vacating the Company’s previous headquarters; (v) amortization of acquired intangible assets of $0.9 million; and (vi) intellectual property litigation expenses of $0.6 million.
Cash, cash equivalents and short and long-term investments were $221.7 million at September 30, 2008.
Alex Lukianov, Chairman and Chief Executive Officer, said, “Our robust third quarter results reflect our growing expertise in leveraging our unique XLIF procedure to drive greater pull through of our comprehensive suite of spinal products. Our recent introductions, including those that address the thoracic and cervical spine, have further enhanced our product depth, allowing us to capture a greater market share. At NASS we unveiled NeuroVision M5, which represents a significant upgrade to our core MAS platform, further distancing our innovative lateral approach from the competition and providing our surgeon customers with an even more intuitive and user friendly system.”
Mr. Lukianov concluded, “We have established a strong corporate infrastructure with the implementation of our ERP system and transition to our new headquarters, which is reinforced by the dedication of our shareowners and their commitment to making NuVasive a major force in the spine industry. Our exclusive sales force, which has grown to 300 sales professionals, has considerable momentum in the marketplace and the opportunity to gain additional market share by selling the full mix of our expanding product portfolio and through geographic expansion. We believe this will lead to revenue growth in 2009 approaching 40% over our revised 2008 revenue guidance with improving operating margins. Overall, we are extremely well positioned to achieve our goals and reach our interim target of $500 million in sales over the next several years.”

 


 

Updated 2008 Financial Guidance
NuVasive is updating its full year 2008 financial guidance as follows:
Revenue:
    $245 million to $247 million, including $9 million in Osteocel; up from previous guidance of $238 million to $240 million, including $15 million in Osteocel
EPS:
    GAAP: $(0.80) to $(0.82)
    Earnings per share $0.05 to $0.07, adjusted for in-process research and development of $20.9 million; a one-time leasehold charge of $4.8 million related to vacating the Company’s previous headquarters; a charge related to transitional support costs for the Company’s ERP system of $4.1 million; and intellectual property litigation expenses of $1.6 million, as detailed in the table below.
    Non-GAAP: $0.70 to $0.72; up from $0.68 to $0.70
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 technology assets and certain other charges. 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. 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 2008 Results
                 
(in thousands, except per share amounts)   $     Per Share  
GAAP net loss per share (A)
  $ (23,079 )   $ (0.64 )
In-process research and development (IPR&D) (C)
    16,700       0.46  
Other adjustments (E)
    7,991       0.22  
 
           
Earnings per share excluding IPR&D and other adjustments
    1,612       0.04  
Stock-based compensation (B)
    5,421       0.14  
Amortization of acquired intangible assets (D)
    931       0.03  
 
           
Non-GAAP earnings per share (A)
  $ 7,964     $ 0.21  
 
           
Shares used in computing GAAP net loss per share (A)
            35,931  
 
             
Shares used in computing non-GAAP net loss per share (A)
            37,927  
 
             
Reconciliation of Full Year 2008 Guidance
                 
    Range for Year Ending
    December 31, 2008
(in thousands, except per share amounts)   Low   High
GAAP net loss per share (A)
  $ (0.82 )   $ (0.80 )
In-process research and development (IPR&D) (C)
    0.58       0.58  
Other adjustments (F)
    0.29       0.29  
     
Earnings per share excluding IPR&D and other adjustments
    0.05       0.07  
Stock-based compensation (B)
    0.56       0.56  
Amortization of acquired intangible assets (D)
    0.09       0.09  
     
Non-GAAP earnings per share (A)
  $ 0.70     $ 0.72  
     
Shares used in computing GAAP net loss per share (A)
    35,800       35,800  
     
Shares used in computing non-GAAP net loss per share (A)
    37,600       37,600  
     
 
A-   GAAP net loss per share is calculated using basic weighted shares outstanding; Non-GAAP earnings per share is calculated using diluted weighted shares outstanding.
 
B-   Non-cash stock-based compensation.
 
C-   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.
 
D-   Amortization of purchased technology assets.
 
E-   Other adjustments related to the one-time leasehold termination charge of $4.8 million, transitional support costs of $2.6 million related to the Company’s ERP system and $0.6 million for intellectual property litigation expenses.
 
F-   Other adjustments related to the one-time leasehold termination charge of $4.8 million, transitional support costs of $4.1 million related to the Company’s ERP system and $1.6 million for intellectual property litigation expenses.

 


 

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. A live Web cast of the conference call will be available online from the investor relations page of the Company’s corporate Web site at www.nuvasive.com.
After the live Web cast, the call will remain available on NuVasive’s Web site, www.nuvasive.com, through November 22, 2008. In addition, a telephonic replay of the call will be available until November 5, 2008. 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 298534.
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 $4.2 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 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 three categories of current product offerings: NeuroVision® a proprietary software-driven nerve avoidance system; MaXcess® a unique split-blade design retraction system; and specialized implants, like SpheRx® and CoRoent®, that collectively minimize soft tissue disruption during spine surgery while allowing maximum visualization 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 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 Company’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 risk that Company may encounter unanticipated difficulty integrating the Osteocel product into its product line and may be unable to generate expected revenues or profitability from Osteocel; the uncertain process of seeking regulatory approval or clearance for Company’s products or devices, including risks that devices currently under development or in clinical studies (such as NeoDisc®) may not be approved for commercial sale; the risk that the ongoing patent litigation with Medtronic could result in a substantial judgment or settlement obligation; the possibility that the FDA may require significant changes to Company’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 Company’s products to patients, hospitals and surgeons; and other risks and uncertainties more fully described in Company’s press releases and periodic filings with the Securities and Exchange Commission. Company’s public filings with the Securities and

 


 

Exchange Commission are available at www.sec.gov. Company 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     Nine Months Ended  
    September 30,     September 30,  
    2008     2007     2008     2007  
         
Revenues
  $ 66,915     $ 38,522     $ 175,501     $ 107,360  
Cost of goods sold
    12,195       6,925       30,845       19,342  
 
                       
Gross Profit
    54,720       31,597       144,656       88,018  
 
                               
Operating expenses:
                               
Sales, marketing and administrative
    54,557       29,480       135,975       86,463  
Research and development
    6,396       5,702       19,797       16,463  
In-process research and development
    16,700             20,876        
 
                       
Total operating expenses
    77,653       35,182       176,648       102,926  
 
                               
Interest and other income (expense), net
    (146 )     1,302       764       4,789  
 
                       
Net loss
  $ (23,079 )   $ (2,283 )   $ (31,228 )   $ (10,119 )
 
                       
 
                               
Net loss per share:
                               
Basic and diluted
  $ (0.64 )   $ (0.07 )   $ (0.88 )   $ (0.29 )
 
                       
Weighted average shares — basic and diluted
    35,931       34,940       35,674       34,638  
 
                       

 


 

NuVasive, Inc.
Unaudited Condensed Consolidated Balance Sheets
(
in thousands)
                 
    September 30,    
    2008   December 31, 2007
     
Assets
               
Current assets:
               
Cash and cash equivalents
  $ 104,388     $ 61,915  
Short-term investments
    72,157       19,247  
Accounts receivable, net
    46,072       27,496  
Inventory, net
    58,418       36,280  
Prepaid expenses and other current assets
    3,352       1,240  
     
Total current assets
    284,387       146,178  
 
               
Property and equipment, net of accumulated depreciation
    73,159       43,538  
 
               
Intangible assets, net of accumulated amortization
    57,041       24,496  
Long-term marketable securities
    45,148       8,536  
Other assets
    8,892       2,939  
     
Total assets
  $ 468,627     $ 225,687  
     
Liabilities and Stockholders’ Equity
               
Current liabilities:
               
Accounts payable and accrued liabilities
  $ 20,078     $ 13,839  
Accrued payroll and related expenses
    13,853       12,075  
Royalties payable
    2,310       2,076  
     
Total current liabilities
    36,241       27,990  
Senior convertible notes
    230,000        
Long-term liabilities
    27,226       1,119  
Commitments and contingencies
               
Stockholders’ equity:
               
Common stock
    36       35  
Additional paid-in capital
    374,695       364,469  
Accumulated other comprehensive income (loss)
    (363 )     54  
Accumulated deficit
    (199,208 )     (167,980 )
     
Total stockholders’ equity
    175,160       196,578  
     
Total liabilities and stockholders’ equity
  $ 468,627     $ 225,687  
     

 


 

NuVasive, Inc.
Unaudited Condensed Consolidated Statements of Cash Flows

(in thousands)
                 
    Nine Months Ended September 30,
    2008   2007
     
Operating activities:
               
Net loss
  $ (31,228 )   $ (10,119 )
Adjustments to reconcile net loss to net cash used in operating activities:
               
Depreciation and amortization
    15,671       9,619  
Stock-based compensation
    15,719       9,977  
In-process research and development
    20,876        
Leasehold abandonment
    4,486        
Other non-cash adjustments
    1,109       1,124  
Changes in operating assets and liabilities:
               
Accounts receivable
    (18,986 )     (5,871 )
Inventory
    (22,136 )     (11,041 )
Prepaid expenses and other current assets
    (941 )     (28 )
Accounts payable and accrued liabilities
    3,898       2,537  
Accrued payroll and related expenses
    1,778       2,230  
     
Net cash used in operating activities
    (9,754 )     (1,572 )
Investing activities:
               
Cash paid for pedicle screw technology
    (6,256 )      
Cash paid for acquisition of Radius Medical LLC
          (6,970 )
Cash paid for acquisition of Osteocel Business Unit
    (35,000 )      
Purchases of property and equipment
    (34,161 )     (14,103 )
Sales of short-term investments
    30,159       98,218  
Purchases of short-term investments
    (83,069 )     (56,131 )
Sales of long-term investments
    14,778       7,500  
Purchases of long-term investments
    (51,390 )     (16,003 )
Other assets
    544       (167 )
     
Net cash provided by (used in) investing activities
    (164,395 )     12,344  
Financing activities:
               
Payment of long-term liabilities
    (300 )     (300 )
Issuance of Senior Convertible Notes
    222,414        
Purchase of convertible note hedges
    (45,758 )      
Sale of warrants
    31,786        
Issuance of common stock
    8,480       4,392  
     
Net cash provided by financing activities
    216,622       4,092  
Increase in cash and cash equivalents
    42,473       14,864  
Cash and cash equivalents at beginning of period
    61,915       41,476  
     
Cash and cash equivalents at end of period
  $ 104,388     $ 56,340