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8-K - FORM 8-K - RTI SURGICAL, INC.d8k.htm

 

FOR RELEASE AT 8:00 AM ET

  For more information, contact:

NOV. 4, 2010

  Robert Jordheim
  Chief Financial Officer
  rjordheim@rtix.com
  Wendy Crites Wacker, APR
  Corporate Communications
  wwacker@rtix.com
  Phone (386) 418-8888

RTI BIOLOGICS ANNOUNCES 2010 THIRD QUARTER RESULTS

– Company Will Hold Conference Call at 9:00 a.m. ET –

ALACHUA, Fla. (Nov. 4, 2010) – RTI Biologics Inc. (RTI) (Nasdaq: RTIX), a leading provider of orthopedic and other biologic implants, reported operating results for the third quarter ended Sept. 30, 2010 as follows:

Quarterly Highlights:

 

   

Achieved quarterly revenues of $41.8 million, with gross margin of 48 percent.

 

   

Achieved growth in the domestic sports medicine business of 20 percent over third quarter 2009.

 

   

Signed an exclusive, 10-year distribution agreement with Zimmer Dental Inc. for biologic implants for the dental market worldwide.

 

   

Signed an exclusive agreement with Athersys Inc. to provide RTI access to its Multipotent Adult Progenitor Cell (MAPC) technologies.

 

   

Signed a distribution agreement with SeaSpine, a new distributor for spinal implants, and launched a new cervical construct.

 

   

Launched a new spine implant with Medtronic.

 

   

Net loss of $133.1 million, or $2.43 per fully diluted share, included a non-cash goodwill impairment charge.

 

   

Adjusted net income, excluding the impairment charge, was $1.6 million, or $0.03 per fully diluted share.

“Revenues in the third quarter met expectations as our direct businesses, including sports medicine, demonstrated continued strength. In addition, we are pleased to have completed our revised


distribution agreement with Zimmer and signed the licensing agreement with Athersys during the quarter,” said Brian K. Hutchison, chairman and CEO of RTI. “We remain confident that we will reach our financial goals for the rest of the year despite challenging conditions in some of our end markets.”

Revenues of $41.8 million for the third quarter of 2010 decreased 2 percent compared to the third quarter of 2009. Domestic revenues of $37.6 million for the third quarter increased 1 percent on the strength of the direct sports medicine business. International revenues of $4.2 million decreased 23 percent primarily due to economic weakness in several international markets. During the third quarter, currency exchange fluctuations resulted in a decrease in revenues of $376,000.

For the third quarter of 2010, the company reported a net loss of $133.1 million and a net loss per fully diluted share of $2.43 based on 54.8 million fully diluted shares outstanding, compared to net income of $2.3 million and net income per fully diluted share of $0.04 for the third quarter 2009, based on 55.0 million fully diluted shares outstanding.

Third quarter results include a decrease in income of $134.7 million, or $2.46 per fully diluted share, due to a non-cash goodwill impairment charge. The impairment charge is a result of an analysis of recorded goodwill in accordance with the financial accounting and reporting requirements of the Financial Accounting Standards Board ASC 350, Goodwill and Other Intangible Assets, considering the decline in the market value of the company’s equity during the third quarter.

2010 Outlook

The company reaffirmed previously issued 2010 fiscal guidance that full year revenues are estimated to be between $165 million and $168 million. Excluding the impact of the goodwill impairment charge taken in the third quarter, the full year earnings per fully diluted share are expected to be in the range of $0.10 to $0.12, based on 55.0 million fully diluted shares outstanding.

Conference Call

RTI will host a conference call and simultaneous audio webcast to discuss the third quarter results at 9:00 a.m. ET today. The conference call can be accessed by dialing (877) 383-7419. The webcast can be accessed through the investor section of RTI’s website at www.rtix.com. A telephone replay of


the call will be available through Dec. 4, 2010 and can be accessed by calling (800) 642-1687, pass code 17891989; the replay will also be available at www.rtix.com.

Use of Non-GAAP Financial Measures

A reconciliation of the company’s non-GAAP financial measures to the corresponding GAAP measures, and an explanation of the company’s use of the non-GAAP measures, is included in the exhibits to this press release.

About RTI Biologics Inc.

RTI Biologics Inc. is a leading provider of sterile biologic implants for surgeries around the world with a commitment to advancing science, safety and innovation. RTI prepares human donated tissue and bovine tissue for transplantation through extensive testing and screening, precision shaping and using proprietary, validated processes. These allograft and xenograft implants are used in orthopedic, dental and other specialty surgeries.

RTI’s innovations continuously raise the bar of science and safety for biologics – from being the first company to offer precision-tooled bone implants and assembled technology to maximize each gift of donation, to inventing validated sterilization processes that include viral inactivation steps. Two such processes – the BioCleanse® Tissue Sterilization Process and the Tutoplast® Tissue Sterilization Process – have a combined record of more than two million implants distributed with zero incidence of allograft-associated infection. These processes have been validated by tissue type to inactivate or remove viruses, bacteria, fungi and spores from the tissue while maintaining biocompatibility and functionality.

RTI’s worldwide corporate headquarters are located in Alachua, Fla., with international locations in Germany and France. The company is accredited by the American Association of Tissue Banks in the United States.

Forward Looking Statement

This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations, estimates and projections about our industry, our management’s beliefs and certain


assumptions made by our management. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, except for historical information, any statements made in this communication about anticipated financial results, growth rates, new product introductions, future operational improvements and results or regulatory approvals or changes to agreements with distributors also are forward-looking statements. These statements are not guarantees of future performance and are subject to risks and uncertainties, including the risks described in public filings with the U.S. Securities and Exchange Commission (SEC). Our actual results may differ materially from the anticipated results reflected in these forward-looking statements. Copies of the company’s SEC filings may be obtained by contacting the company or the SEC or by visiting RTI’s website at www.rtix.com or the SEC’s website at www.sec.gov.


 

RTI BIOLOGICS, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Operations

(In thousands, except share and per share data)

(Unaudited)

 

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

Revenues:

        

Fees from tissue distribution

   $ 40,793      $ 41,556      $ 117,899      $ 118,961   

Other revenues

     1,043        1,257        2,896        3,606   
                                

Total revenues

     41,836        42,813        120,795        122,567   

Costs of processing and distribution

     21,950        22,199        64,994        65,003   
                                

Gross profit

     19,886        20,614        55,801        57,564   
                                

Expenses:

        

Marketing, general and administrative

     15,630        14,812        44,935        44,876   

Research and development

     2,076        2,187        7,010        5,843   

Goodwill impairment

     134,681        —          134,681        —     

Restructuring charges

     —          —          —          42   

Asset abandonments

     3        125        18        208   
                                

Total expenses

     152,390        17,124        186,644        50,969   
                                

Operating (loss) income

     (132,504     3,490        (130,843     6,595   
                                

Total other expense—net

     (168     (339     (364     (431
                                

(Loss) income before income tax provision

     (132,672     3,151        (131,207     6,164   

Income tax provision

     (387     (838     (958     (1,798
                                

Net (loss) income

   $ (133,059   $ 2,313      $ (132,165   $ 4,366   
                                

Net (loss) income per common share—basic

   $ (2.43   $ 0.04      $ (2.42   $ 0.08   
                                

Net (loss) income per common share—diluted

   $ (2.43   $ 0.04      $ (2.42   $ 0.08   
                                

Weighted average shares outstanding—basic

     54,806,262        54,386,604        54,703,890        54,287,007   
                                

Weighted average shares outstanding—diluted

     54,806,262        54,954,665        54,703,890        54,729,147   
                                


 

RTI BIOLOGICS, INC. AND SUBSIDIARIES

Reconciliation of Net Loss and Net Loss Per Diluted Share to

Adjusted Net Income and Adjusted Net Income Per Diluted Share

(In thousands except per share data)

(Unaudited)

 

       Three Months Ended  
       September 30, 2010      September 30, 2009  
       Net
Loss
     Impact
per Diluted
Share
     Net
Income
       Impact
per Diluted
Share
 

GAAP results

     $ (133,059    $ (2.43    $ 2,313         $ 0.04   

Goodwill impairment

       134,681         2.46         —             —     

Tax effect

       —           —           —             —     
                                       

Adjusted results

     $ 1,622       $ 0.03       $ 2,313         $ 0.04   
                                       
       Nine Months Ended  
       September 30, 2010      September 30, 2009  
       Net
Loss
     Impact
per Diluted
Share
     Net
Income
       Impact
per Diluted
Share
 

GAAP results

     $ (132,165    $ (2.42    $ 4,366         $ 0.08   

Goodwill impairment

       134,681         2.46         —             —     

Tax effect

       —           —           —             —     
                                       

Adjusted results

     $ 2,516       $     0.05       $     4,366         $     0.08   
                                       

Use of Non-GAAP Financial Measures

To supplement RTI Biologics’ condensed consolidated financial statements presented on a GAAP basis, the company discloses certain non-GAAP financial measures that exclude certain amounts, including non-GAAP net income and non-GAAP impact per fully diluted share. These non-GAAP financial measures are not in accordance with, or an alternative for, generally accepted accounting principles in the United States. Reconciliations of non-GAAP financial measures to the corresponding GAAP measures are included in the reconciliation above.

The following is an explanation of the adjustment that management excluded as part of the non-GAAP measures for the three and nine month periods ended September 30, 2010 as well as the reason for excluding the individual item.

Goodwill impairment charge – This adjustment relates to evaluating the goodwill associated with the purchase of Tutogen Medical Inc. Management removes the impact of the goodwill impairment charge from the Company’s operating results to assist in assessing its operating performance in the current period and to supplement a comparison to the Company’s past operating performance.

Material Limitations Associated with the Use of Non-GAAP Financial Measures

Non-GAAP net income and non-GAAP impact per fully diluted share should not be considered in isolation, or as a replacement for GAAP measures.


 

Usefulness of Non-GAAP Financial Measures to Investors

The Company believes that presenting non-GAAP net income and non-GAAP impact per fully diluted share in addition to the related GAAP measures provide investors greater transparency to the information used by management in its financial decision-making which excludes the impairment charges. The Company further believes that providing this information better enables RTI Biologics’ investors to understand the Company’s overall core performance and to evaluate the methodology used by management to assess and measure such performance.


 

RTI BIOLOGICS, INC. AND SUBSIDIARIES

Condensed Consolidated Revenues

(In thousands)

(Unaudited)

 

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

Fees from tissue distribution:

                   

Sports medicine

     $     10,887         $     9,493         $     32,751         $     29,211   

Spine

       9,743           10,857           24,474           31,527   

Dental

       7,714           6,969           22,061           21,584   

Surgical specialties

       6,800           8,422           18,885           19,638   

BGS and general orthopedic

       5,649           5,815           19,728           17,001   

Other revenues

       1,043           1,257           2,896           3,606   
                                           

Total revenues

     $ 41,836         $ 42,813         $ 120,795         $ 122,567   
                                           

Domestic revenues

       37,632           37,384           106,830           105,385   

International revenues

       4,204           5,429           13,965           17,182   
                                           

Total revenues

     $ 41,836         $ 42,813         $ 120,795         $ 122,567   
                                           


 

RTI BIOLOGICS, INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

(In thousands)

(Unaudited)

 

     September 30,
2010
     December 31,
2009
 

Assets

     

Cash and cash equivalents

   $ 15,548       $ 17,382   

Accounts receivable—net

     21,450         22,228   

Inventories—net

     89,626         93,935   

Prepaid and other current assets

     37,002         19,397   
                 

Total current assets

     163,626         152,942   

Property, plant and equipment—net

     44,537         46,562   

Goodwill

     —           134,681   

Other assets—net

     24,699         20,322   
                 

Total assets

   $ 232,862       $ 354,507   
                 

Liabilities and Stockholders’ Equity

     

Accounts payable

   $ 11,906       $ 19,844   

Accrued expenses and other current liabilities

     19,332         14,191   

Short-term obligations and current portion of long-term obligations

     2,503         3,963   
                 

Total current liabilities

     33,741         37,998   

Deferred revenue

     23,554         10,381   

Long-term liabilities

     16,438         16,239   
                 

Total liabilities

     73,733         64,618   

Stockholders’ equity:

     

Common stock and additional paid-in capital

     408,423         406,380   

Accumulated other comprehensive loss

     (1,012      (374

Accumulated deficit

     (248,282      (116,117
                 

Total stockholders’ equity

     159,129         289,889   
                 

Total liabilities and stockholders’ equity

   $ 232,862       $ 354,507   
                 


 

RTI BIOLOGICS, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Cash Flows

(In thousands)

(Unaudited)

 

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

Cash flows from operating activities:

        

Net (loss) income

   $ (133,059   $ 2,313      $ (132,165   $ 4,366   

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

        

Depreciation and amortization expense

     1,886        1,734        5,529        5,415   

Stock-based compensation

     479        423        1,290        1,259   

Goodwill impairment

     134,681        —          134,681        —     

Deferred revenue

     —          8,000        —          8,000   

Change in working capital

     (3,809     (8,423     (4,872     (19,127

Other items to reconcile to net cash
(used in) provided by operating activities

     (1,009     1,490        (1,518     1,462   
                                

Net cash (used in) provided by operating activities

     (831     5,537        2,945        1,375   
                                

Cash flows from investing activities:

        

Purchases of property, plant and equipment

     (1,727     (1,138     (2,388     (3,046

Proceeds from sale of property, plant and equipment

     —          —          —          18   

Patent and acquired intangible asset costs

     (1,060     (99     (1,283     (323
                                

Net cash used in investing activities

     (2,787     (1,237     (3,671     (3,351
                                

Cash flows from financing activities:

        

Proceeds from exercise of common stock options

     19        416        764        515   

Excess tax benefit from exercise of common stock options

     —          176        —          186   

Net proceeds (payments) on short-term obligations

     163        445        (886     (2,437

Proceeds from long-term obligations

     5,500        3,029        9,750        8,578   

Payments on long-term obligations

     (4,274     (2,162     (10,713     (4,590
                                

Net cash provided by (used in) financing activities

     1,408        1,904        (1,085     2,252   
                                

Effect of exchange rate changes on cash and cash equivalents

     29        72        (23     91   
                                

Net (decrease) increase in cash and cash equivalents

     (2,181     6,276        (1,834     367   

Cash and cash equivalents, beginning of period

     17,729        14,167        17,382        20,076   
                                

Cash and cash equivalents, end of period

   $ 15,548      $ 20,443      $ 15,548      $ 20,443