Press Releases

AxoGen, Inc. Reports 2017 First Quarter Financial Results

Record Q1 Revenue of $12.2 million, representing 51% growth over prior year

ALACHUA, Fla., May 04, 2017 (GLOBE NEWSWIRE) -- AxoGen, Inc. (NASDAQ:AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today reported financial results and business highlights for the first quarter ended March 31, 2017.

First Quarter 2017 Financial Results and Recent Business Highlights

  • Revenue of $12.2 million, up 51% compared to $8.1 million in the first quarter of 2016
  • Gross margin of 84.4% compared to 82.7% in the first quarter of 2016
  • Net loss for the first quarter of 2017 is $3.8 million, or $0.11 per share, compared with a net loss of $3.7 million, or $0.12 per share, in the first quarter of 2016
  • Adjusted EBITDA loss of $2.2 million compared to Adjusted EBITDA loss of $2.3 million in Q1 2016

"We are pleased to complete another successful quarter, with record revenues of $12.2 million and growth of 51 percent,” stated Karen Zaderej, President and Chief Executive Officer. ”We are successfully executing against our strategic initiatives and driving awareness and growth in the emerging peripheral nerve repair market.”
  
Additional First Quarter and Recent Operational Highlights

  • Increased active accounts in the first quarter to 465, up 37% from 340 in Q1 2016
  • We ended the quarter with 49 direct sales reps and have 50 as of today's call; we also have 20 independent distributors
  • Conducted three national education courses in the first quarter, and four year-to-date
  • Increased the number of peer reviewed clinical publications for our surgical portfolio by six to a total of 50 year to date
  • Conducted a second clinical advisory panel with leading reconstructive breast surgeons - the panel reviewed patient, surgeon, and health care stakeholder perspectives and needs, as well as how the AxoGen portfolio of products may help surgeons overcome current clinical challenges related to restoring breast sensation for women who choose autologous reconstruction following a mastectomy  
  • Ended the quarter with $25.9 million in cash compared to $30 million at the end of 2016. Net cash burn in Q1 was $4.1 million and includes $1.2 million payment of the 2016 all-employee annual performance bonus
  • Ended the quarter with $25 million of total bank debt, compared to $25 million at the end of 2016

“We continue to focus on surgeon education and growing the body of clinical evidence for our nerve repair solutions,” added Zaderej. “As a result we are building awareness of peripheral nerve repair and expanding usage of our products with innovator and early adopter surgeons, while also working to develop the middle adopter market.”

2017 Financial Guidance
Management reiterates 2017 annual revenue will grow at least 40% over 2016 revenue and gross margins will remain above 80%.

Upcoming Investor Events
Members of the AxoGen senior management team will participate at the following upcoming conferences and events:

  • Jefferies Global Healthcare Conference in New York City on June 6
  • JMP Securities Conference in New York City on June 21-22

Conference Call
The Company will host a conference call and webcast for the investment community today at 4:30 p.m. ET. Investors interested in participating by phone are invited to call toll free at 1-877-407-0993 or use the direct dial-in number 1-201-689-8795. Those interested in listening to the conference call live via the Internet can do so by visiting the Investors page of the Company’s website at www.axogeninc.com and clicking on the webcast link on the Investors home page.

Following the conference call, a replay will be available on the Company’s website at www.axogeninc.com under Investors.

About AxoGen
AxoGen (AXGN) is a global leader in innovative surgical solutions for peripheral nerve injuries. AxoGen is the only company focused specifically on the science, development and commercialization of technologies for peripheral nerve regeneration and repair. We are passionate about restoring nerve function and quality of life to patients with peripheral nerve injuries by providing innovative, clinically proven and economically effective repair solutions for surgeons and health care providers. Peripheral nerves provide the pathways for both motor and sensory signals throughout the body. Every day, people suffer traumatic injuries or undergo surgical procedures that impact the function of their peripheral nerves. Damage to a peripheral nerve can result in the loss of muscle or organ function, the loss of sensory feeling, or the initiation of pain.

AxoGen's portfolio of products includes Avance® Nerve Graft, an off-the-shelf processed human nerve allograft for bridging severed nerves without the comorbidities associated with a second surgical site, AxoGuard® Nerve Connector, a porcine submucosa extracellular matrix (ECM) coaptation aid for tensionless repair of severed nerves, AxoGuard® Nerve Protector, a porcine submucosa ECM product used to wrap and protect injured peripheral nerves and reinforce the nerve reconstruction while preventing soft tissue attachments, and Avive® Soft Tissue Membrane, a minimally processed human umbilical cord membrane that may be used as a resorbable soft tissue covering to separate tissue layers and modulate inflammation in the surgical bed. Along with these core surgical products, AxoGen also offers AcroVal™ Neurosensory & Motor Testing System and AxoTouch™ Two-Point Discriminator. These evaluation and measurement tools assist health care professionals in detecting changes in sensation, assessing return of sensory, grip, and pinch function, evaluating effective treatment interventions, and providing feedback to patients on nerve function. The AxoGen portfolio of products is available in the United States, Canada, the United Kingdom, and several other European and international countries.

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," "continue," "may," "should," "will," and 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 our assessment on our internal control over financial reporting, our growth, our 2017 guidance, product development, product potential, financial performance, sales growth, product adoption, market awareness of our products, data validation, our visibility at and sponsorship of conferences and educational events. 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, except as required by law, AxoGen assumes no responsibility to update any forward-looking statements, whether as a result of new information, future events, or otherwise.

                     
AXOGEN, INC.  
CONDENSED CONSOLIDATED BALANCE SHEETS  
   
   
    March 31,          
2017 December 31,  
(unaudited) 2016    
Assets                
Current assets:                
Cash and cash equivalents $ 25,913,765         $ 30,014,405      
Accounts receivable, net   8,383,925           8,052,203      
Inventory   5,850,730           5,458,840      
Prepaid expenses and other   749,437           511,804      
Total current assets   40,897,857           44,037,252      
Property and equipment, net   1,484,279           1,494,247      
Intangible assets   890,688           828,979      
  $ 43,272,824         $ 46,360,478      
Liabilities and Shareholders’ Equity (Deficit)                  
Current liabilities:                  
Borrowings under revolving loan agreement $ 3,976,320           $ 4,025,023      
Accounts payable and accrued expenses   6,660,267             7,002,165      
Current maturities of long term obligations   22,913             20,899      
Deferred revenue, current   35,250           33,282      
Total current liabilities   10,694,750           11,081,369      
Long Term Obligations, net of current maturities and deferred financing fees   20,276,634             20,265,745      
Deferred lease   89,888             --      
Deferred revenue   86,818           92,215      
Total liabilities   31,148,090           31,439,329      
Shareholders’ equity (deficit):                  
Common stock, $.01 par value; 50,000,000 shares authorized; 33,063,960 and 33,008,865 shares issued and outstanding   330,639           330,088      
Additional paid-in capital   133,439,943           132,474,884      
Accumulated deficit   (121,645,848 )         (117,883,823 )    
Total shareholders’ equity    12,124,734           14,921,149      
  $ 43,272,824         $ 46,360,478      
                     
     
AXOGEN, INC.  
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS  
Three Months ended March 31, 2017 and 2016  
(unaudited)  
     
    2017         2016  
Revenues    12,241,073           $   8,111,759      
Cost of goods sold     1,915,648               1,405,591      
Gross profit     10,325,425               6,706,168      
Costs and expenses:                    
Sales and marketing     8,610,482               6,205,875      
Research and development     1,411,136               978,340      
General and administrative     3,504,039               2,144,757      
Total costs and expenses     13,525,657               9,328,972      
Loss from operations     (3,200,232 )             (2,622,804 )    
Other expense:                    
Interest expense     (507,549 )             (1,003,027 )    
Interest expense – deferred financing costs     (44,491 )             (30,810 )    
Other expense     (9,753 )             (19,450 )    
Total other expense      (561,793 )             (1,053,287 )    
Net loss   (3,762,025 )         $   (3,676,091 )    
Weighted Average Common Shares outstanding – basic and diluted     33,026,433               29,994,066      
Loss Per Common share – basic and diluted   (0.11 )     $   (0.12 )    
     









 
 
AXOGEN, INC.  
RECONCILIATION OF GAAP FINANCIAL MEASURES TO NON-GAAP FINANCIAL MEASURES  
Three Months ended March 31, 2017 and 2016  
(unaudited)  
                     
    Three Months Ended    
    March 31,       March 31,    
2017       2016      
Net loss $   (3,762,025 )         $   (3,676,091 )    
  Depreciation and amortization expense     108,359               78,856      
  Amortization expense of intangible assets     23,189               16,016      
  Income Taxes     9,801               21,427      
  Interest expense     507,549               1,003,027      
  Interest expense - deferred financing costs     44,491               30,810      
  EBITDA - non GAAP $   (3,068,636 )         $   (2,525,955 )    
                     
  Non Cash Stock Compensation Expense     848,589           182,955      
  Adjusted EBITDA - non GAAP $   (2,220,047 )     $   (2,343,000 )    
 
 
 
AXOGEN, INC.  
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS  
Three Months ended March 31, 2017 and 2016  
(unaudited)  
   
  2017   2016  
Cash flows from operating activities:                    
Net loss $   (3,762,025 )         $   (3,676,091 )    
Adjustments to reconcile net loss to net cash used for operating activities:                    
Depreciation     108,359               78,856      
Amortization of intangible assets     23,189               16,016      
Amortization of deferred financing costs     44,491               30,810      
Provision for bad debt     34,747               80,651      
Share-based compensation     848,589               182,955      
Interest added to note payable    --                71,950      
Change in assets and liabilities:                    
Accounts receivable     (366,469 )             (588,243 )    
Inventory     (391,890 )             (581,980 )    
Prepaid expenses and other     (237,633 )             (274,114 )    
Accounts payable and accrued expenses     (341,899 )             55,479      
Deferred revenue     86,459               (5,396 )    
Net cash used for operating activities     (3,954,082 )             (4,609,107 )    
                     
Cash flows from investing activities:                    
Purchase of property and equipment     (98,391 )             (402,927 )    
Acquisition of intangible assets     (84,898 )             (85,416 )    
Net cash used for investing activities     (183,289 )             (488,343 )    
                     
Cash flows from financing activities:                    
Borrowing on revolving loan     11,247,114              --       
Payments on revolving loan     (11,295,817 )            --       
Repayments of long term debt     (5,158 )            --       
Debt issuance costs     (26,429 )            --       
Proceeds from exercise of stock options     117,021               136,702      
Net cash provided by financing activities     36,731               136,702      
                     
Net increase (decrease)  in cash and cash equivalents     (4,100,640 )             (4,960,748 )    
Cash and cash equivalents, beginning of year     30,014,405               25,909,500      
Cash and cash equivalents, end of period $   25,913,765           $   20,948,752      
                     
Supplemental disclosures of cash flow activity:                    
Cash paid for interest $   505,020           $   900,410    

 

AXOGEN, INC.                
RECONCILIATION OF GAAP FINANCIAL MEASURES TO NON-GAAP FINANCIAL MEASURES  
(unaudited)  
   
                   
    Quarter Ended       Quarter Ended       Quarter Ended       Quarter Ended       Year Ended       Quarter Ended  
    March 31,     June 30,     September 30,     December 31,     December 31,     March 31,
2016   2016
    2016   2016
    2016   2017
 
Net loss $ (3,676,091 )     $ (2,802,696 )     $ (2,305,373 )     $ (5,626,984 )     $ (14,411,144 )     $ (3,762,025 )  
Depreciation and amortization expense   78,856         88,734         95,543         98,484         361,617         108,359    
Amortization expense of intangible assets   16,016         16,017         16,017         26,821         74,871         23,189    
Income Taxes   21,427         --         --         --         --         9,801    
Interest expense   1,003,027         1,163,413         1,089,134         2,130,694         5,386,268         507,549    
Interest expense - deferred financing costs    30,810         32,696         31,748         780,135         875,389         44,491    
EBITDA - non GAAP $ (2,525,955 )     $ (1,501,836 )     $ (1,072,931 )     $ (2,590,850 )     $ (7,712,999 )     $ (3,068,636 )  
                                               
Non Cash Stock Compensation Expense   182,955         569,834         293,575         343,913         1,390,277         848,589    
Adjusted EBITDA - non GAAP $ (2,343,000 )     $ (932,002 )     $ (779,356 )     $ (2,246,937 )     $ (6,322,722 )     $ (2,220,047 )  
   



























 

Contacts:
AxoGen, Inc.
Peter J. Mariani, Chief Financial Officer
InvestorRelations@AxoGenInc.com

The Trout Group – Investor Relations
Brian Korb
646.378.2923
bkorb@troutgroup.com

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Source: AxoGen, Inc.