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8-K - FORM 8-K - Alphatec Holdings, Inc.d8k.htm

Exhibit 99.1

For more information:

Michael O’Neill

Chief Financial Officer

Alphatec Spine, Inc.

(760) 494-6746

investorrelations@alphatecspine.com

Westwicke Partners

Lynn C. Pieper

(415) 202-5678

lynn.pieper@westwicke.com

ALPHATEC SPINE ANNOUNCES THIRD QUARTER 2010 REVENUE

AND FINANCIAL RESULTS

 

   

Revenue of $44.8 million; 49% growth over 3Q 2009; Pro Forma Revenue Growth of 2% over 3Q 2009 and 2.3% Growth on a Constant-Currency Basis

 

   

Adjusted EBITDA of $5.3 million; 11.9% growth over 3Q 2009

 

   

Non-GAAP Net Earnings of $0.7 million; or $0.01 per share

CARLSBAD, Calif., November 8, 2010 – Alphatec Holdings, Inc. (Nasdaq: ATEC), the parent company of Alphatec Spine, Inc., a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, with a focus on treating conditions related to the aging spine, announced today financial results for the fiscal quarter ended September 30, 2010.

Third Quarter 2010 Performance Highlights

 

 

Achieved US revenues of $30.0 million, representing 15.2% year-over-year growth on a GAAP basis, and 3.4% year-over-year growth on a pro forma basis.

 

 

Launched PureGenTM, the Company’s Osteoprogenitor Cell Allograft with the first case completed in September.

 

   

Established Biologics Division at Alphatec Spine, with the addition of Edward Ross, Vice President and General Manager, Biologics as well as dedicated sales specialists to drive biologics product adoption and work with customers as biologics experts.

 

 

Strengthened US sales network with the addition of several independent distribution agents and direct representatives in key strategic markets.

 

 

OsseoFixTM, the Company’s proprietary device for treating vertebral compression fractures and restoration of vertebral height, has been used in over 1,600 patients in Europe through 3Q 2010, representing continued acceleration in product adoption.

 

 

OsseoScrewTM, the Company’s proprietary expandable pedicle screw system, has been used in over 100 patients in Europe through 3Q 2010.

 

 

HelifixTM Interspinous Spacer System, a proprietary minimally invasive non-fusion solution for lumbar spinal stenosis, was launched in Europe with the first cases completed in Switzerland and Germany.

 

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SolusTM ALIF System, a zero-profile, single-action locking implant that is used in anterior lumbar interbody fusion (ALIF) procedures, was launched in Europe with the first cases completed in Germany.

 

   

The Company resubmitted the Solus 510(k) application with a revised indication in the third quarter 2010.

Dirk Kuyper, the Company’s President and Chief Executive Officer, stated “I am proud of the focus of the Alphatec Spine team and our ability to achieve continued revenue growth through execution and key product launches despite the challenges currently facing the spine market”. Mr. Kuyper continued, “2010 has been a transformative year for the Company and in the third quarter we saw a stabilization of our business internationally and a stabilization of pricing here in the US. The Scient’x integration is progressing, and with the launch of PureGen and most of our key technologies in Europe we are well positioned as we enter 2011 to drive towards our goal of being the leading global pure-play spine company. We have the team, the products and the strategic plan to achieve long-term revenue growth and enhanced profitability.”

Third Quarter 2010 Financial Review

Consolidated revenues for the third quarter 2010 were $44.8 million, an increase of $14.7 million, or 49.0%, from the $30.1 million reported for the third quarter 2009. US revenues for the third quarter 2010 were $30.0 million, an increase of 15.2% from the $26.1 million reported for the third quarter 2009.

Gross profit for the third quarter 2010 was $28.9 million, an increase of $8.8 million, or 44.1% over the third quarter 2009 gross profit of $20.1 million. The third quarter 2010 gross margin of 64.5% was below the third quarter 2009 gross margin of 66.7%, primarily due to geographic sales mix associated with our increased international business. The third quarter gross margin of 64.5% was higher than the second quarter 2010 gross margin of 63.5%, reflecting increased manufacturing efficiencies and reduced royalty burden.

Total operating expenses for the third quarter 2010 were $32.4 million, which included $2.4 million of in-process research and development expenses, $5.2 million in operating expenses associated with the addition of the Company’s acquired international operations and $0.7 million of restructuring expenses. Total operating expenses for the third quarter 2009 were $20.9 million and included $1.2 million in acquisition-related expenses.

Adjusted EBITDA was $5.3 million for the third quarter 2010, an increase of $0.6 million compared to adjusted EBITDA of $4.7 million reported for the third quarter 2009. Adjusted EBITDA for the third quarter 2009 included $1.2 million of Scient’x acquisition-related expenses previously recorded in general and administrative expenses.

Net loss for the third quarter 2010 was $3.8 million, or ($0.04) per share (basic and diluted), compared with a net loss of $1.3 million, or ($0.02) per share (basic and diluted) for the third quarter 2009.

Non-GAAP EPS for the third quarter 2010 was $0.01 per share compared to $0.00 per share reported in the third quarter 2009. Non-GAAP EPS excludes the impact of in-process research and development expenses, Scient’x acquisition-related expenses and restructuring expenses.

 

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Cash and cash equivalents were $28.9 million at September 30, 2010. In October 2010, the Company amended and restated its loan agreement with Silicon Valley Bank, and the agreement provides for a $32 million working capital revolving line of credit. The loan agreement provides a significant reduction in debt service and terminates the principal payments that existed in the prior credit facility. The proceeds from the new loan agreement will primarily be used to pay off the Company’s existing credit facility with Silicon Valley Bank and Oxford Finance Corporation.

Updated Full Year 2010 Financial Guidance

Due to continuing uncertainty in the US spine market as it relates to procedure volumes, in addition to international debt and solvency issues impacting government-funded health systems, the Company is adjusting its full-year 2010 guidance as follows:

 

   

GAAP annual revenues of $170 million to $172 million; a reduction from the $177 million to $182 million previously announced

 

   

Pro forma annual revenues of $181 million to $183 million; a reduction from the $188 million to $193 million previously announced

 

   

Adjusted EBITDA of $19 million to $20 million; a reduction from the $21 million to $24 million previously announced

The revised annual pro forma revenue guidance reflects annual growth of 6% to 7% over pro forma 2009 revenues of $170.8 million.

Conference Call

Alphatec Spine will host a conference call today at 2:00 p.m. PT / 5:00 p.m. ET to discuss the results. To participate in the conference call, please visit the investor relations section of the Alphatec Spine website at www.alphatecspine.com. The dial-in numbers are (877) 556-5251 for domestic callers and (720) 545-0036 for international callers. A live webcast of the conference call will be available online on the investor relations section of the Alphatec Spine website at www.alphatecspine.com. The webcast will be recorded and will remain available on the investor relations section of Alphatec Spine’s website for at least 30 days.

About Alphatec Spine

Alphatec Spine, Inc. is a wholly owned subsidiary of Alphatec Holdings, Inc. (Nasdaq:ATEC). Alphatec Spine is a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, primarily focused on the aging spine. The Company’s mission is to combine world-class customer service with innovative, surgeon-driven design that will help improve the aging patient’s quality of life. The Company is poised to achieve its goal through new solutions for patients with osteoporosis, stenosis and other aging spine deformities, improved minimally invasive products and techniques and integrated biologics solutions. In addition to its US operations, the Company also markets its products in over 50 international markets through its subsidiary, Scient’x SA, via a direct sales force in France, Italy and the United Kingdom and via independent distributors in the rest of Europe, the Middle East and Africa, South America and Latin America. In Asia and Australia, the Company markets its products through its subsidiary, Alphatec Pacific, Inc, and through Scient’x’s distributors in China, Korea and Australia.

Also visit the Aging Spine Center, www.agingspinecenter.com, a web-based information portal for healthcare providers and patients regarding aging spine disorders and their treatment. Alphatec Spine is working with the National Osteoporosis Foundation as well as other clinical portals that provide peer-reviewed content, to populate the Aging Spine Center. The interactive website enables patients to review pertinent information about all the key disorders that affect the aging spine in an easy-to-understand format that includes videos, graphics and questions that should be asked of caregivers. Medical information includes published abstracts regarding the aging spine.

 

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Non-GAAP Information for non-GAAP earnings and Adjusted EBITDA

Non-GAAP earnings included in this press release is a non-GAAP (generally accepted accounting principles) financial measure that represents net income (loss) excluding the effects of in-process research and development expenses, acquisition-related expenses, restructuring expenses and litigation settlement expenses. Management does not consider these expenses when it makes certain evaluations of the operations of the Company. Non-GAAP earnings, as defined above, may not be similar to non-GAAP earnings measures used by other companies and is not a measurement under GAAP.

Adjusted EBITDA included in this press release is a non-GAAP financial measure that represents net income (loss) excluding the effects of interest, taxes, depreciation, amortization, stock-based compensation expense, and other income or expense items, such as in-process research and development expense and acquisition-related expenses. Adjusted EBITDA, as defined above, may not be similar to adjusted EBITDA measures used by other companies and is not a measurement under GAAP.

Though management finds non-GAAP-based earnings or loss and adjusted EBITDA useful for evaluating aspects of the Company’s business, its reliance on these measures are limited because excluded items often have a material effect on the Company’s earnings and earnings per common share calculated in accordance with GAAP. The Company believes that non-GAAP earnings and adjusted EBITDA provides investors with an additional tool for evaluating the Company’s core performance, which management uses in its own evaluation of continuing operating performance, and a base-line for assessing the future earnings potential of the Company. While the GAAP results are more complete, the Company prefers to allow investors to have these supplemental metrics since, with reconciliation to GAAP, they may provide greater insight into the Company’s financial results.

Forward Looking Statements

This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainty. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These forward-looking statements include, but are not limited to: Alphatec Spine’s ability to accelerate new product momentum, bring to market differentiated products and commercialize its product pipeline. Alphatec Spine cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors, including, but not limited to, the following: Alphatec Spine’s ability to meet its 2010 revenue, adjusted EBITDA, and earnings projections, the ability to successfully integrate Scient’x and Alphatec, the US and global growth rate of the spine market overall and the growth rate related to aging and elderly patients, the impact of macroeconomic conditions on the spine market both inside the US and outside of the US, the negative impact of pricing reductions in the spine market, uncertainty of success in developing new products or products currently in Alphatec Spine’s pipeline, the successful global launch of the Alphatec Spine’s new products and the products in its development pipeline including PureGen, HeleFix, OsseoFix, OsseoScrew, and Solus, failure to achieve acceptance of Alphatec Spine’s products by the surgeon community, failure to obtain FDA clearance or approval for new products, or unexpected or prolonged delays in the process, Alphatec Spine’s ability to develop

 

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and expand its business in the United States, Asia, Europe, the Middle East and Africa and Latin America continuation of favorable third party payor reimbursement for procedures performed using Alphatec Spine’s products, price erosion, unanticipated expenses or liabilities or other adverse events affecting cash flow or Alphatec Spine’s ability to successfully control its costs or achieve profitability, uncertainty of additional funding, Alphatec Spine’s ability to compete with other competing products and with emerging new technologies, product liability exposure, patent infringement claims and claims related to Alphatec Spine’s or a third party’s intellectual property. Please refer to the risks detailed from time to time in Alphatec Spine’s SEC reports, including quarterly reports on Form 10-Q, reports on Form 8-K and annual reports on Form 10-K. Alphatec Spine disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.

# # #

 

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ALPHATEC HOLDINGS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands - unaudited)

 

     September 30,
2010
     December 31,
2009
 
ASSETS      

Current assets:

     

Cash and cash equivalents

   $ 28,854       $ 10,085   

Accounts receivable, net

     43,151         24,766   

Inventories, net

     53,552         29,515   

Prepaid expenses and other current assets

     5,851         3,128   

Deferred income tax assets

     1,817         128   
                 

Total current assets

     133,225         67,622   

Property and equipment, net

     39,415         30,356   

Goodwill

     172,318         60,113   

Intangibles, net

     42,354         2,296   

Other assets

     3,081         1,501   
                 

Total assets

   $ 390,393       $ 161,888   
                 
LIABILITIES AND STOCKHOLDERS’ EQUITY      

Current liabilities:

     

Accounts payable

   $ 19,272       $ 12,781   

Accrued expenses

     24,580         16,439   

Deferred revenue

     2,984         2,135   

Other current liabilities

     1,033         —     

Current portion of long-term debt

     10,147         6,724   
                 

Total current liabilities

     58,016         38,079   

Total long term liabilities

     39,191         25,377   

Redeemable preferred stock

     23,603         23,603   

Stockholders’ equity - Alphatec

     269,043         74,829   

Non-controlling interest

     540         —     
                 

Total liabilities and stockholders’ equity

   $ 390,393       $ 161,888   
                 


ALPHATEC HOLDINGS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share amounts - unaudited)

 

     Three Months Ended
September 30,
    Nine Months Ended
September 30,
 
     2010     2009     2010     2009  

Revenues

   $ 44,846      $ 30,103      $ 125,592      $ 87,358   

Cost of revenues

     15,546        10,028        43,516        28,311   

Amortization of acquired intangible assets

     373        —          742        —     
                                

Total cost of revenues

     15,919        10,028        44,258        28,311   
                                

Gross profit

     28,927        20,075        81,334        59,047   

Operating expenses:

        

Research and development

     3,751        3,630        12,347        9,933   

In-process research and development

     2,425        50        2,967        5,833   

Sales and marketing

     17,052        12,088        47,571        36,618   

General and administrative

     7,933        3,895        21,500        15,216   

Amortization of acquired intangible assets

     533        —          1,002        —     

Transaction related expenses

     6        1,240        3,651        1,240   

Restructuring expenses

     702        —          2,389        —     
                                

Total operating expenses

     32,402        20,903        91,427        68,840   
                                

Operating loss

     (3,475     (828     (10,093     (9,793

Interest and other income (expense), net

     (1,085     (630     (2,363     (2,508
                                

Loss from continuing operations before taxes

     (4,560     (1,458     (12,456     (12,301

Income tax benefit

     (770     (94     (899     (68
                                

Loss from continuing operations

     (3,790     (1,364     (11,557     (12,233

Income from discontinued operations, net of tax

     —          81        78        264   
                                

Net loss

   $ (3,790   $ (1,283   $ (11,479   $ (11,969
                                

Net loss attributable to non-controlling interest

   $ —        $ —        $ —        $ —     
                                

Net loss attributable to Alphatec

   $ (3,790   $ (1,283   $ (11,479   $ (11,969
                                

Net income (loss) per common share:

        

Basic and diluted net loss from continuing operations

   $ (0.04   $ (0.02   $ (0.15   $ (0.25

Basic and diluted net income from discontinued operations

     —          0.00        0.00        0.00   
                                

Basic and diluted net loss per share

   $ (0.04   $ (0.02   $ (0.15   $ (0.25
                                

Weighted-average shares - basic and diluted

     86,990        51,516        75,394        48,411   


ALPHATEC HOLDINGS, INC.

RECONCILIATION OF NON-GAAP FINANCIAL MEASURES

(in thousands - unaudited)

 

     Three Months Ended
September 30,
    Nine Months Ended
September 30,
 
     2010     2009     2010     2009  

Operating loss, as reported

   $ (3,475   $ (828   $ (10,093   $ (9,793

Add back:

        

Depreciation

     3,586        2,292        9,462        6,234   

Amortization of intangibles

     122        854        1,245        2,410   

Amortization of acquired intangibles

     906        —          1,744        —     
                                

Total EBITDA

     1,139        2,318        2,358        (1,149

Add back significant items:

        

Stock-based compensation

     573        1,098        2,326        2,563   

In-process research and development

     2,425        50        2,967        5,833   

Acquisition-related inventory step-up

     419        —          832        —     

Transaction related expenses

     6        1,240        3,651        1,240   

Restructuring expenses

     702        —          2,389        —     
                                

EBITDA, as adjusted for significant items

   $ 5,264      $ 4,706      $ 14,523      $ 8,487   
                                

Net loss, as reported

   $ (3,790   $ (1,283   $ (11,479   $ (11,969

Add back:

        

In-process research and development

     2,425        50        2,967        5,833   

Acquisition-related inventory step-up

     419        —          832        —     

Amortization of acquired intangibles

     906        —          1,744        —     

Transaction related expenses

     6        1,240        3,651        1,240   

Restructuring expenses

     702        —          2,389        —     
                                

Net loss, as adjusted for significant items

   $ 668      $ 7      $ 104      $ (4,896
                                

Net loss per common share - basic and diluted

   $ (0.04   $ (0.02   $ (0.15   $ (0.25

Add back:

        

In-process research and development

     0.03        0.00        0.04        0.12   

Acquisition-related inventory step-up

     0.00        —          0.01        —     

Amortization of acquired intangibles

     0.01        —          0.02        —     

Transaction related expenses

     0.00        0.02        0.05        0.03   

Restructuring expenses

     0.01        —          0.03        —     
                                

Net loss per common share - basic and diluted, as adjusted for significant items

   $ 0.01      $ 0.00      $ 0.00      $ (0.10
                                


ALPHATEC HOLDINGS, INC.

RECONCILIATION OF GEOGRAPHIC SEGMENT REVENUES AND GROSS PROFIT

(in thousands, except gross profit margin percentages - unaudited)

 

     Three Months Ended
September 30,
          Impact  from
Foreign

Currency
 
     2010     2009     % Change    

Revenues by geographic segment

        

U.S.

   $ 30,010      $ 26,052        15.2     0.0

Europe

     5,770        1,036        456.9     -4.4

Asia

     6,020        3,015        99.7     4.7

Rest of world

     3,046        —          100.0     -4.4
                    

Total revenues

   $ 44,846      $ 30,103        49.0     -0.3
                    

Gross profit by geographic segment

        

U.S.

   $ 23,346      $ 17,937       

Europe

     1,595        412       

Asia

     3,143        1,726       

Rest of world

     843        —         
                    

Total gross profit

   $ 28,927      $ 20,075       
                    

Gross profit margin by geographic segment

        

U.S.

     77.8     68.9    

Europe

     27.6     39.8    

Asia

     52.2     57.2    

Rest of world

     27.7     0.0    
                    

Total gross profit margin

     64.5     66.7    
                    
     Nine Months Ended
September 30,
          Impact  from
Foreign

Currency
 
     2010     2009     % Change    

Revenues by geographic segment

        

U.S.

   $ 87,763      $ 76,243        15.1     0.0

Europe

     18,543        2,415        667.8     -5.4

Asia

     14,265        8,700        64.0     1.2

Rest of world

     5,021        —          100.0     -5.4
                    

Total revenues

   $ 125,592      $ 87,358        43.8     -0.9
                    

Gross profit by geographic segment

        

U.S.

   $ 64,145      $ 53,100       

Europe

     7,279        965       

Asia

     7,905        4,982       

Rest of world

     2,005        —         
                    

Total gross profit

   $ 81,334      $ 59,047       
                    

Gross profit margin by geographic segment

        

U.S.

     73.1     69.6    

Europe

     39.3     40.0    

Asia

     55.4     57.3    

Rest of world

     39.9     0.0    
                    

Total gross profit margin

     64.8     67.6    
                    

Footnotes:

 

1) IMC operating results have been removed from Asia revenues and gross profit for 2010 and 2009 periods presented.
2) The impact from foreign currency represents the percentage change in 2010 revenues due to the change in foreign exchange rates for the periods presented.


ALPHATEC HOLDINGS, INC.

PRO FORMA REVENUES BY GEOGRAPHIC SEGMENT

(in thousands - unaudited)

 

     Three Months Ended      % Change  
     September 30,            Constant  
     2010      2009      Reported     Currency  

Pro Forma Revenues by geographic segment

          

U.S.

   $ 30,010       $ 29,034         3.4     3.4

Europe

     5,770         6,813         -15.3     -11.4

Asia

     6,020         4,856         24.0     18.4

Rest of world

     3,046         3,246         -6.2     -1.8
                      

Total revenues

   $ 44,846       $ 43,949         2.0     2.3
                      
     Nine Months Ended      % Change  
     September 30,            Constant  
     2010      2009      Reported     Currency  

Pro Forma Revenues by geographic segment

          

U.S.

   $ 90,738       $ 84,607         7.2     7.2

Europe

     23,398         17,520         33.6     39.6

Asia

     15,924         13,670         16.5     15.3

Rest of world

     6,867         8,417         -18.4     -15.0
                      

Total revenues

   $ 136,927       $ 124,214         10.2     11.2
                      

Footnotes:

 

1) IMC operating results have been removed from Asia pro forma revenues for 2010 and 2009 periods presented.
2) Pro Forma revenues for all periods presented include the results of Scient’x as if the Scient’x acquisition had occurred on January 1, 2009.
3) % Change - Constant Currency represents the change in 2010 pro forma revenue had the 2010 foreign exchange rates remained constant with 2009 foreign exchange rates.