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8-K - FORM 8-K - Axogen, Inc.d353140d8k.htm

Exhibit 99.1

 

LOGO

AxoGen, Inc. Announces Record First Quarter 2012 Revenues

First Quarter Highlights

 

   

Record revenues of $1.65 million, a 47% increase from first quarter 2011

 

   

Gross profit over first quarter 2011 increased 55% to a record $1.21 million

 

   

Gross profit margins improved to 73% compared to 70% for the same period in 2011

ALACHUA, FL – May 14, 2012 – AxoGen, Inc. (AXGN.OB), a leading regenerative medicine company focused on the commercialization of proprietary products and technologies for peripheral nerve reconstruction and regeneration, today announced revenues for the first quarter ended March 31, 2012 of $1.65 million, a 47% increase over 2011 first quarter revenues of $1.12 million.

“This quarter’s record performance has been the direct result of our increase in sales and marketing activity,” commented Karen Zaderej, Chief Executive Officer of AxoGen, Inc. “During the first quarter we continued to expand our sales force, while continuing to get hospital approval for AxoGen products and training and developing the sales team. Our growing base of sales representatives, combined with increasing surgeon awareness of our technologies and clinical data, creates a strong environment for our continued growth.”

Revenues

Revenues for the period increased to a record $1.65 million, or 47%, compared to $1.12 million in 2011. The improved results were primarily due to an increase in new accounts as well as stronger sales penetration into key accounts.

Revenues increased 21% over fourth quarter revenues of $1.36 million.

Gross Profit

Gross profit reached $1.21 million, a 55% increase, for first quarter 2012 up from $0.78 million reported for the same period 2011. The higher gross profit reflects lower manufacturing and labor cost and the absence of one-time manufacturing startup expenses reported during the first quarter of 2011. The gross profit margin increased to 73% compared to 70% for the same quarter last year.

Sales and Marketing Expenses

As a result of the Company’s investment in additional sales and marketing resources, sales and marketing expenses during the first quarter of 2011 increased to $1.63 million, compared to $0.86 million reported during the same period last year. As of the end of the period, the Company reported 16 direct and 21 independent sales representatives and distributors.

 

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Research and Development Expenses

Research and development expenses increased to $0.30 million during the first quarter of 2012. Substantially all of the research and development expenses relate to expenditures for clinical activity.

General and Administrative Expenses

General and administrative expenses increased to $1.23 million for the quarter, compared to $0.72 million reported last year. This increase was largely driven by payroll and benefit increases and expenses associated with being a public company.

Operating Loss

The Company reported a net loss of $2.11 million, or $0.19 per common share, compared to a net loss of $2.3 million, or $2.21 per common share, reported during the same period in 2011.

Financial Liquidity

At March 31, 2012, the Company had $5.64 million in cash and cash equivalents, with $5.0 million in total debt outstanding.

Earnings Call Information

As previously announced, AxoGen, Inc. management will review first quarter 2012 financials during a conference call scheduled for May 15, 2012 at 11:00 AM Eastern Time. The conference call information is as follows:

 

Conference dial-in:    888.715.1397   
International dial-in    913.312.1227   
Conference ID:    6117124   
Webcast:    www.axogeninc.com/investors.html   

A webcast replay of the conference call will be available under the “Investor” tab on the Company’s website, www.axogeninc.com.

About AxoGen, Inc.

AxoGen (AXGN.OB) is a leading regenerative medicine company with a portfolio of proprietary products and technologies for peripheral nerve reconstruction and regeneration. Every day, people suffer traumatic injuries or undergo surgical procedures that impact the function of their peripheral nerves. Peripheral nerves provide the pathways for both motor and sensory signals throughout the body and their damage can result in the loss of function and feeling. In order to

 

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improve surgical reconstruction and regeneration of peripheral nerves, AxoGen has developed and licensed patented and patent-pending technologies, which are used in its portfolio of products. This portfolio includes Avance® Nerve Graft, the only commercially available allograft nerve for bridging peripheral nerve discontinuities (a gap created when the nerve is severed) of up to 70mm in length.

AxoGen’s portfolio also includes AxoGuard® Nerve Connector, a coaptation aid allowing for close approximation of severed nerves, and AxoGuard® Nerve Protector, a bioscaffold used to reinforce a coaptation site, wrap a partially severed nerve or isolate and protect nerve tissue. AxoGen is bringing the science of nerve repair to life with thousands of surgical implants of AxoGen products performed in hospitals and surgery centers across the United States, including military hospitals serving U.S. service men and women.

AxoGen is the parent of its wholly owned operating subsidiary, AxoGen Corporation. AxoGen’s principal executive office and operations are located in Alachua, FL.

Cautionary Statements Concerning Forward-Looking Statements

This Press Release contains “forward-looking” statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations or predictions of future conditions, events or results based on various assumptions and management’s estimates of trends and economic factors in the markets in which we are active, as well as our business plans. Words such as “expects”, “anticipates”, “intends”, “plans”, “believes”, “seeks”, “estimates”, “projects”, “forecasts”, “may”, “should”, variations of such words and similar expressions are intended to identify such forward-looking statements. The forward-looking statements may include, without limitation, statements regarding product development, product potential or financial performance. The forward-looking statements are subject to risks and uncertainties, which may cause results to differ materially from those set forth in the statements. Forward-looking statements in this release should be evaluated together with the many uncertainties that affect AxoGen’s business and its market, particularly those discussed in the risk factors and cautionary statements in AxoGen’s filings with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and actual results may differ materially from those projected. The forward-looking statements are representative only as of the date they are made, and AxoGen assumes no responsibility to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact:

 

COCKRELL GROUP

Rich Cockrell, President

404.942.3369

Investorrelations@thecockrellgroup.com

www.cockrellgroup.com

  

AxoGen, Inc.

Greg Freitag, Chief Financial Officer

386.462.6856

InvestorRelations@AxoGenInc.com

www.axogeninc.com

 

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AxoGen, Inc.

Condensed Consolidated Balance Sheets

 

     March 31,
2012

(unaudited)
    December 31,
2011
 

Assets

    

Current assets:

    

Cash and cash equivalents

   $ 5,641,947      $ 8,190,781   

Accounts receivable

     893,983        797,654   

Inventory

     2,126,336        1,760,540   

Prepaid expenses and other

     142,257        133,500   
  

 

 

   

 

 

 

Total current assets

     8,804,523        10,882,475   

Property and equipment, net

     221,446        247,824   

Goodwill

     169,987        169,987   

Intangible assets

     911,297        899,480   

Deferred financing costs

     272,563        295,276   

Other Assets

     97,276        —     
  

 

 

   

 

 

 
   $ 10,477,092      $ 12,495,042   
  

 

 

   

 

 

 

Liabilities and Stockholders’ Equity

    

Current liabilities:

    

Accounts payable and accrued expenses

   $ 1,506,373      $ 1,585,100   

Current portion of long-term debt

     918,480        434,734   
  

 

 

   

 

 

 

Total current liabilities

     2,424,853        2,019,834   

Long-term debt

     3,932,229        4,403,737   
  

 

 

   

 

 

 

Total liabilities

     6,357,082        6,423,571   
  

 

 

   

 

 

 

Commitments and contingencies

    

Stockholders’ equity:

    

Common stock, $.01 par value; 50,000,000 shares authorized; 11,062,421 and 11,062,188 shares issued and outstanding

     110,624        110,622   

Additional paid-in capital

     54,549,646        54,391,784   

Accumulated deficit

     (50,540,20     (48,430,95
  

 

 

   

 

 

 

Total stockholders’ equity

     4,120,010        6,071,471   
  

 

 

   

 

 

 
   $ 10,477,092      $ 12,495,042   
  

 

 

   

 

 

 


AxoGen, Inc.

Consolidated Statements of Operations

(unaudited)

 

     Three Months Ended  
     March 31,
2012
    March 31,
2011
 

Revenues

   $ 1,653,430      $ 1,121,561   

Cost of goods sold

     439,158        338,777   
  

 

 

   

 

 

 

Gross profit

     1,214,272        782,784   

Costs and expenses:

    

Sales and marketing

     1,628,608        856,976   

Research and development

     296,131        105,591   

General and administrative

     1,230,608        722,165   
  

 

 

   

 

 

 

Total costs and expenses

     3,155,347        1,684,732   
  

 

 

   

 

 

 

Loss from operations

     (1,941,075     (901,948
  

 

 

   

 

 

 

Other income (expense):

    

Interest expense

     (125,125     (202,799

Interest expense – deferred financing costs

     (34,951     (1,059,167

Change in fair value of warrant liability

     —          (119,460

Other income (expense)

     (8,174     (7,900
  

 

 

   

 

 

 

Total other income (expense)

     (168,250     (1,389,326
  

 

 

   

 

 

 

Net loss

     (2,109,325     (2,291,274

Preferred Stock dividends (assumes all paid)

     —          375,779   
  

 

 

   

 

 

 

Net loss available to common shareholders

   $ (2,109,325   $ (2,667,053
  

 

 

   

 

 

 

Weighted Average Common Shares outstanding – basic and diluted

     11,062,339        1,205,600   
  

 

 

   

 

 

 

Loss Per Common share – basic and diluted

   $ (0.19   $ (2.21
  

 

 

   

 

 

 


AxoGen, Inc.

Consolidated Statements of Cash Flows

(unaudited)

 

     Three Months Ended March 31,  
     2012     2011  

Cash flows from operating activities:

    

Net loss

   $ (2,109,325   $ (2,291,274

Adjustments to reconcile net loss to net cash used for operating activities:

    

Depreciation

     55,691        75,129   

Amortization of intangible assets

     29,419        10,676   

Amortization of deferred financing costs

     22,713        1,059,167   

Amortization of debt discount

     12,238        8,578   

Stock-based compensation

     157,860        30,000   

Change in fair value of warrant liability

     —          119,460   

Change in assets and liabilities:

    

Accounts receivable

     (96,329     (85,251

Inventory

     (365,796     30,429   

Prepaid expenses and other

     (106,033     32,973   

Accounts payable and accrued expenses

     (78,727     (146,867
  

 

 

   

 

 

 

Net cash used for operating activities

     (2,478,289     (1,156,980
  

 

 

   

 

 

 

Cash flows from investing activities:

    

Purchase of property and equipment

     (29,313     —     

Acquisition of intangible assets

     (41,236     (17,981
  

 

 

   

 

 

 

Net cash used for investing activities

     (70,549     (17,981
  

 

 

   

 

 

 

Cash flows from financing activities:

    

Debt issuance costs

     —          (37,346

Proceeds from exercise of stock options

     63        —     

Payment of fractional shares from Merger

     (59     —     
  

 

 

   

 

 

 

Net cash provided by (used for) financing activities

     4        (37,346
  

 

 

   

 

 

 

Net decrease in cash and cash equivalents

     (2,548,834     (1,212,307

Cash and cash equivalents, beginning of year

     8,190,781        1,799,048   
  

 

 

   

 

 

 

Cash and cash equivalents, end of period

   $ 5,641,947      $ 586,741   

Supplemental disclosures of cash flow activity:

    

Cash paid for interest

   $ 125,125      $ 184,051   

Supplemental disclosure of non-cash investing and financing activities:

    

Accretion of dividends of Series B preferred stock

   $ —        $ 110,849   

Accretion of dividends of Series C preferred stock

     —          187,601   

Accretion of dividends of Series D preferred stock

     —          77,329