AXGN Axogen Inc.

22.1
+0.57  (+3%)
Previous Close 21.53
Open 21.46
52 Week Low 7.16
52 Week High 22.89
Market Cap $897,674,729
Shares 40,618,766
Float 33,357,375
Enterprise Value $854,275,854
Volume 261,110
Av. Daily Volume 247,996
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  1. ALACHUA, Fla., Feb. 22, 2021 (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 fourth quarter and full year ended December 31, 2020.

    Fourth Quarter 2020 Financial Results and Business Highlights

    • Net revenue was $32.5 million during the quarter, a 15% increase compared to fourth quarter 2019 revenue of $28.2 million.
    • Gross margin was 83.2% for the quarter, compared to 82.7% in the fourth quarter of 2019.
    • Net loss for the quarter was $6.0 million, or $0.15 per share, compared to a net loss of $7.0 million, or $0.18 per share, in the fourth quarter of 2019.
    • Adjusted net loss was…

    ALACHUA, Fla., Feb. 22, 2021 (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 fourth quarter and full year ended December 31, 2020.

    Fourth Quarter 2020 Financial Results and Business Highlights

    • Net revenue was $32.5 million during the quarter, a 15% increase compared to fourth quarter 2019 revenue of $28.2 million.
    • Gross margin was 83.2% for the quarter, compared to 82.7% in the fourth quarter of 2019.
    • Net loss for the quarter was $6.0 million, or $0.15 per share, compared to a net loss of $7.0 million, or $0.18 per share, in the fourth quarter of 2019.
    • Adjusted net loss was $3.3 million for the quarter, or $0.08 per share, compared with adjusted net loss of $4.0 million, or $0.10 per share, in the fourth quarter of 2019.
    • Adjusted EBITDA loss was $2.1 million for the quarter, compared to an adjusted EBITDA loss of $4.2 million in the fourth quarter of 2019.
    • The balance of cash, cash equivalents, and investments on December 31, 2020 was $110.8 million, compared to a balance of $106.7 million on September 30, 2020. The net increase includes $3.5 million of equity proceeds received from Oberland Capital related to the option exercise associated with their debt facility, positive operating cash flow in the quarter of $3.4 million, partially offset by capital expenditures of $2.8 million related to our new facilities in Tampa and Dayton.
    • Active accounts in the fourth quarter were 893, a 12% increase compared to 797 in the fourth quarter a year ago, and revenue from the top 10% of our active accounts continued to represent approximately 35% of total revenue in the quarter.

    "Our fourth quarter and 2020 results are a testament to the resilience of our Axogen team and the ability to successfully execute our focused strategy while also managing the challenges associated with the COVID-19 pandemic," said Karen Zaderej, chairman, CEO, and president of Axogen, Inc. "We adapted quickly and met each challenge with innovative thinking and a patient-first approach. As a result of the efficiencies and skills gained, we are now even better positioned to meet the growing surgeon demand for our evidence-based nerve repair solutions."

    Full-Year 2020 Financial Results and Business Highlights

    • Full-year 2020 revenue was $112.3 million, a 5% increase compared to 2019 revenue of $106.7 million.
    • Gross margin was 80.8% for the full year, compared to 83.7% in 2019.
    • Net loss for the full year was $23.8 million, or $0.60 per share, compared to $29.1 million, or $0.74 per share, in 2019.
    • Adjusted net loss was $15.3 million for the full year, or $0.38 per share, compared to $16.4 million, or $0.42 per share, in 2019
    • Adjusted EBITDA loss was $13.1 million for the full year, compared to an adjusted EBITDA loss of $17.7 million in 2019.
    • Ended the year with 111 direct sales representatives, compared to 109 at the end of 2019.
    • Ended the year with 147 peer-reviewed clinical publications featuring Axogen's nerve repair product portfolio.
    • Surpassed 50,000 Avance® Nerve Grafts implanted since launch.

    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 the leading company focused specifically on the science, development, and commercialization of technologies for peripheral nerve regeneration and repair. Axogen employees are passionate about helping to restore peripheral nerve function and quality of life to patients with physical damage or transection to peripheral nerves 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. Physical damage to a peripheral nerve, or the inability to properly reconnect peripheral nerves, can result in the loss of muscle or organ function, the loss of sensory feeling, or the initiation of pain.

    Axogen's platform for peripheral nerve repair features a comprehensive portfolio of products, including Avance® Nerve Graft, a biologically active off-the-shelf processed human nerve allograft for bridging severed peripheral 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 peripheral nerves; Axoguard Nerve Protector®, a porcine submucosa ECM product used to wrap and protect damaged peripheral nerves and reinforce the nerve reconstruction while preventing soft tissue attachments; Axoguard Nerve Cap®, a porcine submucosa ECM product used to protect a peripheral nerve end and separate the nerve from the surrounding environment to reduce the development of symptomatic or painful neuroma; and Avive® Soft Tissue Membrane, a processed human umbilical cord intended for surgical use as a resorbable soft tissue barrier. The Axogen portfolio of products is available in the United States, Canada, Germany, United Kingdom, Spain, South Korea, and several other 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," "goals," 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 related to the expected impact of COVID-19 on our business, statements regarding our growth, product development, product potential, financial performance, sales growth, product adoption, market awareness of our products, data validation, our assessment of our internal controls over financial reporting, our visibility at and sponsorship of conferences and educational events. The forward-looking statements are and will be subject to risks and uncertainties, which may cause actual results to differ materially from those expressed or implied in such forward-looking statements. Forward-looking statements contained in this press release should be evaluated together with the many uncertainties that affect our business and our market, particularly those discussed under Part I, Item 1A., "Risk Factors," of our Annual Report on Form 10-K, as amended on Form 10-K/A, for the fiscal year ended December 31, 2019, as well as other risks and cautionary statements set forth in our filings with the U.S. Securities and Exchange Commission. Forward-looking statements are not a guarantee 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 applicable law, we assume no responsibility to publicly update or revise any forward-looking statements, whether as a result of new information, future events, changed circumstances, or otherwise. 

    About Non-GAAP Financial Measures

    To supplement our consolidated financial statements, we use the non-GAAP financial measures of EBITDA, which measures earnings before interest, income taxes, depreciation and amortization, and Adjusted EBITDA which further excludes non-cash stock compensation expense and litigation and related expenses. We also use the non-GAAP financial measures of Adjusted Net Income or Loss and Adjusted Net Income or Loss Per Common Share - basic and diluted which excludes non-cash stock compensation expense and litigation and related expenses from Net Loss and Net Loss Per Common Share - basic and diluted, respectively. These non-GAAP measures are not based on any comprehensive set of accounting rules or principles and should not be considered a substitute for, or superior to, financial measures calculated in accordance with GAAP, and may be different from non-GAAP measures used by other companies. In addition, these non-GAAP measures should be read in conjunction with our financial statements prepared in accordance with GAAP. The reconciliations of Axogen's GAAP financial measures to the corresponding non-GAAP measures should be carefully evaluated.

    We use these non-GAAP financial measures for financial and operational decision-making and as a means to evaluate period-to-period comparisons. We believe that these non-GAAP financial measures provide meaningful supplemental information regarding our performance and that both management and investors benefit from referring to these non-GAAP financial measures in assessing our performance and when planning, forecasting, and analyzing future periods. We believe these non-GAAP financial measures are useful to investors because (1) they allow for greater transparency with respect to key metrics used by management in its financial and operational decision-making and (2) they are used by our institutional investors and the analyst community to help them analyze the performance of our business.

    Contact:

    Axogen, Inc.

    Peter J. Mariani, Chief Financial Officer







             
    AXOGEN, INC.    
    CONDENSED CONSOLIDATED BALANCE SHEETS    
    (unaudited)    
             
             
      December 31,December 31,    
       2020  2019     
    Assets        
    Current assets:        
    Cash and cash equivalents $48,767  $35,724     
    Restricted Cash  6,842   6,000     
    Investments  55,199   60,786     
    Accounts receivable, net  17,618   16,944     
    Inventory  12,529   13,861     
    Prepaid expenses and other  4,296   1,706     
    Total current assets  145,251   135,021     
    Property and equipment, net  38,398   14,887     
    Operating lease right-of-use assets  15,614   3,133     
    Finance lease right-of-use assets  64   87     
    Intangible assets  2,054   1,515     
    Total assets $201,381  $154,643     
             
    Liabilities and Shareholders' Equity        
    Current liabilities:        
    Accounts payable and accrued expenses $21,968  $19,144     
    Current maturities of lease liabilities  863   1,736     
    Total current liabilities  22,831   20,880     
    Long-term debt, net of financing fees  32,027        
    Debt derivative liability  2,497        
    Long-term lease obligations  20,874   1,595     
    Other long-term liabilities  3   15     
    Total liabilities  78,232   22,490     
    Shareholders' equity:        
    Common stock, $.01 par value; 100,000,000 shares authorized; 40,618,766 and 39,589,775 shares issued and outstanding  406   396     
    Additional paid-in capital  326,390   311,618     
    Accumulated deficit  (203,647)  (179,861)    
    Total shareholders' equity   123,149   132,153     
    Total liabilities and shareholders' equity $201,381  $154,643     
             
             
             
    AXOGEN, INC.
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
    Three and Twelve Months ended December 31, 2020 and 2019
    (unaudited)
             
      Three Months Ended Fiscal Year Ended
      Dec 31, Dec 31, Dec 31, Dec 31,
       2020   2019   2020   2019 
    Revenues  $32,495  $28,162  $112,300  $106,712 
      Cost of goods sold  5,463   4,881   21,581   17,349 
      Gross profit  27,032   23,281   90,719   89,363 
    Costs and expenses:          
      Sales and marketing  19,805   18,804   69,659   71,950 
      Research and development  4,931   4,912   17,846   17,514 
      General and administrative  7,670   6,984   26,396   31,305 
    Total costs and expenses  32,406   30,700   113,901   120,769 
    Loss from operations  (5,374)  (7,419)  (23,182)  (31,406)
    Other income (expense):        
      Interest income  29   439   605   2,364 
      Interest expense  (595)  (8)  (1,054)  (40)
      Change in fair value of derivative liabilities  (46)     (117)   
      Other expense  (24)  (50)  (38)  (53)
    Total other expense   (636)  381   (604)  2,271 
    Net loss $(6,010) $(7,038) $(23,786) $(29,135)
             
    Weighted average common shares outstanding – basic and diluted  40,246   39,485   39,967   39,235 
    Loss per common share – basic and diluted $(0.15) $(0.18) $(0.60) $(0.74)
             
    Adjusted net loss - non GAAP  (3,265)  (3,978)  (15,281)  (16,364)
    Adjusted net loss per common share - basic and diluted $(0.08) $(0.10) $(0.38) $(0.42)
             
             
             
    AXOGEN, INC.
    RECONCILIATION OF GAAP FINANCIAL MEASURES TO NON-GAAP FINANCIAL MEASURES
    Three and Twelve Months ended December 31, 2020 and 2019
    (unaudited)
             
      Three Months Ended Fiscal Year Ended
      Dec 31, Dec 31, Dec 31, Dec 31,
      2020   2019   2020   2019 
    Net loss $(6,010) $(7,038) $(23,786) $(29,135)
    Depreciation and amortization expense  556   299   1,660   1,056 
    Investment income  (29)  (439)  (605)  (2,364)
    Income tax  77   (52)  77   (67)
    Interest expense  595   8   1,054   40 
    EBITDA - non GAAP $(4,811) $(7,222) $(21,600) $(30,470)
             
    Non cash stock compensation expense  2,745   2,920   8,470   10,304 
    Litigation and related costs     140   35   2,467 
     Adjusted EBITDA - non GAAP $(2,066) $(4,162) $(13,095) $(17,699)
             
    Net loss $(6,010) $(7,038) $(23,786) $(29,135)
    Non cash stock compensation expense  2,745   2,920   8,470   10,304 
    Litigation and related costs     140   35   2,467 
    Adjusted Net Loss - non GAAP $(3,265) $(3,978) $(15,281) $(16,364)
                     
    Weighted average common shares outstanding – basic and diluted  40,246   39,485   39,967   39,235 
                     
    Adjusted net loss per common share - basic and diluted $(0.08) $(0.10) $(0.38) $(0.42)
             
             
             
    AXOGEN, INC.
    CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY
    Fiscal Year Ended December 31, 2020 and 2019
    (unaudited)
             
      Common Stock Additional Paid-in Capital Accumulated Deficit Total Shareholders' Equity
    For the Three Months Ended December 31, 2020:        
    Balance at September 30, 2020 $401  $318,949  $(197,637) $121,713 
    Net Loss  -   -   (6,010)  (6,010)
    Stock-based compensation  -   2,745   -   2,745 
    Shares surrendered by employees to pay tax withholdings  1   (6)    (5)
    Issuance of common stock from exercise of option (Oberland)  2   3,680   -   3,682 
    Exercise of stock options and employee stock purchase plan  2   1,022   -   1,024 
    Balance at December 31, 2020 $406  $326,390  $(203,647) $123,149 
             
    For the Fiscal Year Ended December 31, 2020:        
    Balance at December 31, 2019 $396  $311,618  $(179,861) $132,153 
    Net Loss  -   -   (23,786)  (23,786)
    Stock-based compensation    8,470   -   8,470 
    Shares surrendered by employees to pay tax withholdings  -   (670)  -   (670)
    Issuance of common stock from exercise of option (Oberland), net of derivative 2   3,680   -   3,682 
    Issuance of restricted and performance stock units  2   (2)  -   - 
    Exercise of stock options and employee stock purchase plan  6   3,294   -   3,300 
    Balance at December 31, 2020 $406  $326,390  $(203,647) $123,149 
             
             
    For the Three Months Ended December 31, 2019:        
    Balance at September 30, 2019 $395  $307,839  $(172,823) $135,411 
    Net Loss  -   -   (7,038)  (7,038)
    Issuance of common stock  -   -   -   - 
    Stock-based compensation  -   2,919   -   2,919 
    Exercise of stock options and employee stock purchase plan  1   860   -   861 
    Balance at December 31, 2019 $396  $311,618  $(179,861) $132,153 
             
    For the Fiscal Year Ended December 31, 2019:        
    Balance at December 31, 2018 $389  $297,319  $(150,726) $146,982 
    Net Loss  -   -   (29,135)  (29,135)
    Stock-based compensation  -   10,304   -   10,304 
    Exercise of stock options and employee stock purchase plan  7   3,995   -   4,002 
    Balance at December 31, 2019 $396  $311,618  $(179,861) $132,153 
             
             
             
             
             
    AXOGEN, INC.    
    CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS    
    Fiscal Year Ended December 31, 2020 and 2019    
    (unaudited)    
             
      Fiscal Year    
      December 31, December 31,    
       2020   2019     
    Cash flows from operating activities:        
    Net loss $(23,786) $(29,135)    
    Adjustments to reconcile net loss to net cash used in operating activities:        
    Depreciation  1,507   933     
    Amortization of right-of-use assets  1,800   1,821     
    Amortization of intangible assets  153   123     
    Write-down of trademark  -   104     
    Loss on disposal of assets  3        
    Amortization of deferred financing costs  232        
    Change in fair value of derivatives  117        
    Provision for bad debt  (105)  514     
    Provision for inventory write down  2,242   1,887     
    Change in investment gains and losses  (47)  (972)    
    Share-based compensation  8,470   10,304     
    Change in assets and liabilities:        
    Accounts receivable  (635)  (2,136)    
    Inventory  (910)  (3,767)    
    Prepaid expenses and other  (2,524)  (661)    
    Accounts payable and accrued expenses  4,958   2,920     
    Operating Lease Obligations  (1,086)  (1,773)    
    Cash paid for interest portion of Finance Leases  (3)  (4)    
    Contract and other liabilities  (12)  (30)    
    Net cash used in operating activities  (9,626)  (19,872)    
             
    Cash flows from investing activities:        
    Purchase of property and equipment  (21,905)  (4,664)    
    Purchase of short-term investments  (77,806)  (121,074)    
    Sale/Maturities of short-term investments  83,440   153,571     
    Cash payments for intangible assets  (692)  (562)    
    Net cash provided by/ (used for) investing activities  (16,963)  27,271     
             
    Cash flows from financing activities:        
    Proceeds from the issuance of common stock  3,500        
    Proceeds from the issuance of long-term debt  35,000        
    Proceeds from the paycheck protection program  7,820        
    Repayment of the paycheck protection program  (7,820)       
    Payment of debt issuance costs  (642)       
    Payments of employee tax withholding in exchange of common stock awards  (670)       
    Cash paid for debt portion of finance leases  (14)  29     
    Proceeds from exercise of stock options and warrants  3,300   4,002     
    Net cash provided by financing activities  40,474   4,031     
             
    Net increase in cash, cash equivalents and restricted cash  13,885   11,430     
    Cash, cash equivalents and restricted cash, beginning of year  41,724   30,294     
    Cash, cash equivalents and restricted cash, end of period $55,609  $41,724     
             
    Supplemental disclosures of cash flow activity:        
    Cash paid for interest $822  $34     
    Supplemental disclosure of non-cash investing and financing activities        
    Acquisition of fixed assets in accounts payable and accrued expenses $1,077  $3,212     
    Acquisition of leasehold asset $5,250  $-     
    Right-of-use asset and operating lease liability $14,259  $26     
    Embedded derivative associated with the long term debt $2,563  $-     
    Conversion of the Oberland Option $182  $-     
             

     



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  2. ALACHUA, Fla., Feb. 18, 2021 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ:AXGN), a global leader in developing and marketing innovative surgical solutions for damage or transection to peripheral nerves, today announced completion of pilot phase analysis for its REPOSE clinical study. 

    ALACHUA, Fla., Feb. 18, 2021 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ:AXGN), a global leader in developing and marketing innovative surgical solutions for damage or transection to peripheral nerves, today announced completion of pilot phase analysis for its REPOSE clinical study. 

    Analysis of the REPOSE study's 15-subject single arm pilot phase demonstrated that subjects experienced a clinically significant reduction in pain from baseline at each of the 3, 6, 9, and 12 month timepoints following surgical excision of the neuroma and placement of Axoguard Nerve Cap® (p<0.0001). Specifically, the study observed a mean reduction in pain of 69 points at 3 months and 80 points at 12 months as measured on the 100-point Visual Analog Scale (VAS). Additionally, subjects experienced clinically meaningful improvements in Fatigue, Physical Function, Sleep Disturbance, Pain Interference, Pain Intensity, and Pain Behavior as measured by the validated PROMIS® questionnaires, and pain medication utilization data showed positive indicators for a reduction of pain medication burden, including opioids, following the procedure.   

    "Neuroma pain can be a challenging clinical condition to manage, and results from historical treatment options, both surgical and pharmacological, can be limited," said Craig Thomajan, DPM, FACFAS, FAENS, Peripheral Nerve Surgeon at Austin Foot and Ankle Specialists, and the lead clinical investigator for REPOSE. "We are pleased with the early successes from REPOSE and are excited to continue this meaningful study. Access to impactful technologies for the treatment and prevention of symptomatic neuromas offers patients an opportunity for reduced pain and improved quality of life."

    "We are pleased that the analysis of this pilot phase clinical data demonstrates the potential impact our Axoguard Nerve Cap can have on symptomatic neuroma pain. The outcomes reinforce the assumptions used in our study modeling and exceed those reported for standard neurectomy," said Karen Zaderej, chairman, CEO, and president. "We believe the comparative phase of the study will support the role of Axoguard Nerve Cap in the management of symptomatic neuroma. We continue to be committed to providing surgeons with clinical evidence advancing the science of nerve repair, including surgical treatments that provide clinically meaningful improvements for patients suffering with chronic nerve pain."

    Enrollment in the comparative phase of REPOSE is underway and the company expects enrollment to be completed in the first quarter of 2022, assuming limited impact from COVID-19.

    About REPOSE

    A Multicenter, Prospective, Randomized and Subject Blinded Comparative Study of Axoguard Nerve Cap and Neurectomy for the Treatment of Symptomatic Neuroma and Prevention of Recurrent End-Neuroma Pain (REPOSE) is the company's post-market study comparing placement of Axoguard Nerve Cap to standard neurectomy alone for subjects with symptomatic neuroma pain. The study design includes a 15 subject open label pilot phase and up to 86 subjects in a randomized comparative phase. The study requires a one year follow up period for all subjects and is designed to assess changes in pain scores as measured by Visual Analog Scale, quality of life outcomes, medication usage, and subject satisfaction.

    About Axoguard Nerve Cap

    Axoguard Nerve Cap is a porcine submucosa ECM product used to protect a peripheral nerve end and separate the nerve from the surrounding environment to reduce the development of symptomatic or painful neuroma. Axoguard Nerve Cap provides protection for a peripheral nerve end or stump where repair is unattainable or not desired.

    About Axogen

    Axogen (AXGN) is the leading company focused specifically on the science, development, and commercialization of technologies for peripheral nerve regeneration and repair. Axogen employees are passionate about helping to restore peripheral nerve function and quality of life to patients with physical damage or transection to peripheral nerves 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. Physical damage to a peripheral nerve, or the inability to properly reconnect peripheral nerves, can result in the loss of muscle or organ function, the loss of sensory feeling, or the initiation of pain.

    Axogen's platform for peripheral nerve repair features a comprehensive portfolio of products, including Avance® Nerve Graft, a biologically active off-the-shelf processed human nerve allograft for bridging severed peripheral 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 peripheral nerves; Axoguard® Nerve Protector, a porcine submucosa ECM product used to wrap and protect damaged peripheral nerves and reinforce the nerve reconstruction while preventing soft tissue attachments; Axoguard Nerve Cap®, a porcine submucosa ECM product used to protect a peripheral nerve end and separate the nerve from the surrounding environment to reduce the development of symptomatic or painful neuroma; and Avive® Soft Tissue Membrane, a processed human umbilical cord intended for surgical use as a resorbable soft tissue barrier. The Axogen portfolio of products is available in the United States, Canada, the United Kingdom, South Korea, 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," "goals," 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 related to the expected impact of COVID-19 on our business, statements regarding our growth, product development, product potential, financial performance, sales growth, product adoption, market awareness of our products, data validation, our assessment of our internal controls over financial reporting, our visibility at and sponsorship of conferences and educational events. The forward-looking statements are and will be subject to risks and uncertainties, which may cause actual results to differ materially from those expressed or implied in such forward-looking statements. Forward-looking statements contained in this press release should be evaluated together with the many uncertainties that affect our business and our market, particularly those discussed under Part I, Item 1A., "Risk Factors," of our Annual Report on Form 10-K, as amended on Form 10-K/A, for the fiscal year ended December 31, 2019, as well as other risks and cautionary statements set forth in our filings with the U.S. Securities and Exchange Commission. Forward-looking statements are not a guarantee 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 applicable law, we assume no responsibility to publicly update or revise any forward-looking statements, whether as a result of new information, future events, changed circumstances, or otherwise.

    Contact:

    Axogen, Inc.

    Peter Mariani, Chief Financial Officer



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  3. ALACHUA, Fla., Feb. 04, 2021 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ:AXGN), a global leader in developing and marketing innovative surgical solutions for damage or discontinuity to peripheral nerves, today announced it will participate in two investor conferences in February.

    Karen Zaderej, chairman, CEO, and president, will participate in a fireside chat at the BTIG Virtual MedTech, Digital Health, Life Science & Diagnostic Tools Conference on Thursday, February 18, 2021 at 9:00 a.m. ET.

    Ms. Zaderej will also participate in a fireside discussion at the 10th Annual SVB Leerink Global Healthcare Conference to be held virtually this year. The discussion is scheduled for Wednesday, February 24, 2021 at 2:20 p.m. ET.

    Both discussions will…

    ALACHUA, Fla., Feb. 04, 2021 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ:AXGN), a global leader in developing and marketing innovative surgical solutions for damage or discontinuity to peripheral nerves, today announced it will participate in two investor conferences in February.

    Karen Zaderej, chairman, CEO, and president, will participate in a fireside chat at the BTIG Virtual MedTech, Digital Health, Life Science & Diagnostic Tools Conference on Thursday, February 18, 2021 at 9:00 a.m. ET.

    Ms. Zaderej will also participate in a fireside discussion at the 10th Annual SVB Leerink Global Healthcare Conference to be held virtually this year. The discussion is scheduled for Wednesday, February 24, 2021 at 2:20 p.m. ET.

    Both discussions will be webcast live and can be accessed through the Investors page at www.axogeninc.com. For those not available to listen to the live broadcast, a replay will be archived for 90 days and available through the Investors page on www.axogeninc.com.

    About Axogen

    Axogen (AXGN) is the leading company focused specifically on the science, development and commercialization of technologies for peripheral nerve regeneration and repair. Axogen employees are passionate about helping to restore peripheral nerve function and quality of life to patients with physical damage or transection to peripheral nerves 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. Physical damage to a peripheral nerve, or the inability to properly reconnect peripheral nerves, can result in the loss of muscle or organ function, the loss of sensory feeling, or the initiation of pain.

    Axogen's platform for peripheral nerve repair features a comprehensive portfolio of products, including Avance® Nerve Graft, a biologically active off-the-shelf processed human nerve allograft for bridging severed peripheral 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 peripheral nerves; Axoguard® Nerve Protector, a porcine submucosa ECM product used to wrap and protect damaged peripheral nerves and reinforce the nerve reconstruction while preventing soft tissue attachments; Axoguard® Nerve Cap, a porcine submucosa ECM product used to protect a peripheral nerve end and separate the nerve from the surrounding environment to reduce the development of symptomatic or painful neuroma; and Avive® Soft Tissue Membrane, a processed human umbilical cord intended for surgical use as a resorbable soft tissue barrier. The Axogen portfolio of products is available in the United States, Canada, the United Kingdom, South Korea, and several other European and international countries.

    Contact:

    Axogen, Inc.

    Peter Mariani, Chief Financial Officer



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  4. ALACHUA, Fla., Feb. 01, 2021 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ:AXGN), a global leader in developing and marketing innovative surgical solutions for damage or transection to peripheral nerves, today confirmed that it will report fourth quarter and full-year 2020 financial results on Monday, February 22, 2021 after the market closes. Axogen management will host an investment-community conference call and webcast following the release at 4:30 p.m. ET.

    Investors interested in participating in the conference call by phone may do so by dialing toll free at (877) 407-0993 or use the direct dial-in number at (201) 689-8795. Those interested in listening to the conference call live via the Internet may do so by visiting the Investors page of…

    ALACHUA, Fla., Feb. 01, 2021 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ:AXGN), a global leader in developing and marketing innovative surgical solutions for damage or transection to peripheral nerves, today confirmed that it will report fourth quarter and full-year 2020 financial results on Monday, February 22, 2021 after the market closes. Axogen management will host an investment-community conference call and webcast following the release at 4:30 p.m. ET.

    Investors interested in participating in the conference call by phone may do so by dialing toll free at (877) 407-0993 or use the direct dial-in number at (201) 689-8795. Those interested in listening to the conference call live via the Internet may do so by visiting the Investors page of the company's website at www.axogeninc.com and clicking on the webcast link.

    Following the conference call, a replay will be available in the Investors section of the company's website at www.axogeninc.com.

    About Axogen

    Axogen (AXGN) is the leading company focused specifically on the science, development and commercialization of technologies for peripheral nerve regeneration and repair. Axogen employees are passionate about helping to restore peripheral nerve function and quality of life to patients with physical damage or transection to peripheral nerves 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. Physical damage to a peripheral nerve, or the inability to properly reconnect peripheral nerves, can result in the loss of muscle or organ function, the loss of sensory feeling, or the initiation of pain.

    Axogen's platform for peripheral nerve repair features a comprehensive portfolio of products, including Avance® Nerve Graft, a biologically active off-the-shelf processed human nerve allograft for bridging severed peripheral 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 peripheral nerves; Axoguard® Nerve Protector, a porcine submucosa ECM product used to wrap and protect damaged peripheral nerves and reinforce the nerve reconstruction while preventing soft tissue attachments; Axoguard® Nerve Cap, a porcine submucosa ECM product used to protect a peripheral nerve end and separate the nerve from the surrounding environment to reduce the development of symptomatic or painful neuroma; and Avive® Soft Tissue Membrane, a processed human umbilical cord intended for surgical use as a resorbable soft tissue barrier. The Axogen portfolio of products is available in the United States, Canada, the United Kingdom, South Korea, and several other European and international countries.

    Contact:

    Axogen, Inc.

    Peter Mariani, Chief Financial Officer



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  5. ALACHUA, Fla., Jan. 11, 2021 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ:AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced preliminary unaudited fourth quarter and full-year 2020 revenue.

    Preliminary Unaudited Fourth Quarter and Year-End Performance Highlights

    • Fourth quarter revenue is expected to be at least $32.4 million, a 15% increase compared to fourth quarter 2019 revenue of $28.2 million
    • Full-year 2020 revenue is expected to be at least $112.2 million, a 5% increase compared to 2019 revenue of $106.7 million
    • Ended the fourth quarter with 111 direct sales representatives compared to 110 at the end of the third quarter, and 109 as of December 31, 2019
    • Increased…

    ALACHUA, Fla., Jan. 11, 2021 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ:AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced preliminary unaudited fourth quarter and full-year 2020 revenue.

    Preliminary Unaudited Fourth Quarter and Year-End Performance Highlights

    • Fourth quarter revenue is expected to be at least $32.4 million, a 15% increase compared to fourth quarter 2019 revenue of $28.2 million
    • Full-year 2020 revenue is expected to be at least $112.2 million, a 5% increase compared to 2019 revenue of $106.7 million
    • Ended the fourth quarter with 111 direct sales representatives compared to 110 at the end of the third quarter, and 109 as of December 31, 2019
    • Increased active accounts in the fourth quarter to 893, a 12% increase from 797 in the fourth quarter a year ago
    • Revenue from the top 10% of our active accounts continued to represent approximately 35% of total revenue in the quarter

    "I am pleased with our fourth quarter performance, as we achieved year-over-year revenue growth despite the continued dampening effect of the COVID-19 pandemic," commented Karen Zaderej, chairman, CEO, and president of Axogen, Inc. "While it was a challenging year, our team continued to execute our focused strategy and improved the strength and resilience of our business. I am extremely proud that we achieved an important milestone in 2020, surpassing 50,000 Avance® Nerve Grafts implanted since launch. This accomplishment underscores Axogen's commitment to our mission of 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."

    Investor meetings scheduled this week

    Members of the Axogen senior management team will participate in the Solebury Trout Virtual Management Access Event January 11-14, 2021. These annual meetings provide an opportunity for management to meet individually with investors to discuss Axogen's differentiated platform for nerve repair in an expanding set of applications.

    The results disclosed in this press release are preliminary and unaudited. The Company expects to report full, audited results for the fourth quarter and year ended December 31, 2020 on February 22, 2021. The company's updated corporate presentation is available through the investors page on www.axogeninc.com.

    About Axogen

    Axogen (AXGN) is the leading company focused specifically on the science, development and commercialization of technologies for peripheral nerve regeneration and repair. Axogen employees are passionate about helping to restore peripheral nerve function and quality of life to patients with physical damage or transection to peripheral nerves 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. Physical damage to a peripheral nerve, or the inability to properly reconnect peripheral nerves, can result in the loss of muscle or organ function, the loss of sensory feeling, or the initiation of pain.

    Axogen's platform for peripheral nerve repair features a comprehensive portfolio of products, including Avance® Nerve Graft, a biologically active off-the-shelf processed human nerve allograft for bridging severed peripheral 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 peripheral nerves; Axoguard® Nerve Protector, a porcine submucosa ECM product used to wrap and protect damaged peripheral nerves and reinforce the nerve reconstruction while preventing soft tissue attachments; Axoguard® Nerve Cap, a porcine submucosa ECM product used to protect a peripheral nerve end and separate the nerve from the surrounding environment to reduce the development of symptomatic or painful neuroma; and Avive® Soft Tissue Membrane, a processed human umbilical cord intended for surgical use as a resorbable soft tissue barrier. The Axogen portfolio of products is available in the United States, Canada, the United Kingdom, South Korea, 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," "goals," 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 related to the expected impact of COVID-19 on our business, statements regarding our growth, product development, product potential, financial performance, sales growth, product adoption, market awareness of our products, data validation, our assessment of our internal controls over financial reporting, our visibility at and sponsorship of conferences and educational events. The forward-looking statements are and will be subject to risks and uncertainties, which may cause actual results to differ materially from those expressed or implied in such forward-looking statements. Forward-looking statements contained in this press release should be evaluated together with the many uncertainties that affect our business and our market, particularly those discussed under Part I, Item 1A., "Risk Factors," of our Annual Report on Form 10-K, as amended on Form 10-K/A, for the fiscal year ended December 31, 2019, as well as other risks and cautionary statements set forth in our filings with the U.S. Securities and Exchange Commission. Forward-looking statements are not a guarantee 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 applicable law, we assume no responsibility to publicly update or revise any forward-looking statements, whether as a result of new information, future events, changed circumstances, or otherwise.

    Contact:

    Axogen, Inc.

    Peter J. Mariani, Chief Financial Officer





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