AXGN Axogen Inc.

11.8
-0.42  -3%
Previous Close 12.22
Open 12.26
52 Week Low 7.16
52 Week High 18.84
Market Cap $469,190,892
Shares 39,761,940
Float 32,500,549
Enterprise Value $420,074,906
Volume 102,754
Av. Daily Volume 462,256
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
Avance Nerve Graf
Severed peripheral nerves
Phase 3
Phase 3
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.

Latest News

  1. ALACHUA, Fla., Aug. 05, 2020 (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 second quarter ended June 30, 2020.

    Second Quarter 2020 Financial Results and Recent Business Highlights

    • Net revenue was $22.1 million during the quarter, a decrease of 17% compared to second quarter 2019 revenue of $26.7 million.
    • Gross margin was 74.7% for the quarter, compared to 84.1% in the second quarter of 2019.
    • Net loss was $8.1 million for the quarter, or $0.20 per share, compared to a net loss of $7.0 million, or $0.18 per share, in the second quarter of 2019.
    • Adjusted net loss was $5.9 million…

    ALACHUA, Fla., Aug. 05, 2020 (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 second quarter ended June 30, 2020.

    Second Quarter 2020 Financial Results and Recent Business Highlights

    • Net revenue was $22.1 million during the quarter, a decrease of 17% compared to second quarter 2019 revenue of $26.7 million.
    • Gross margin was 74.7% for the quarter, compared to 84.1% in the second quarter of 2019.
    • Net loss was $8.1 million for the quarter, or $0.20 per share, compared to a net loss of $7.0 million, or $0.18 per share, in the second quarter of 2019.
    • Adjusted net loss was $5.9 million for the quarter, or $0.15 per share, compared with adjusted net loss of $3.7 million, or $0.10 per share, in the second quarter of 2019.
    • Adjusted EBITDA loss was $5.7 million for the quarter, compared to an adjusted EBITDA loss of $4.1 million in the second quarter of 2019.
    • On June 30, 2020 the Company announced a new seven-year, interest-only financing agreement with Oberland Capital, which provides up to $75.0 million in total financing commitments, with $35 million drawn at the close. 
    • The balance of cash, cash equivalents, and investments on June 30, 2020 was $109.9 million, compared to a balance of $89.0 million on March 31, 2020. The net change reflects the receipt of net debt proceeds of $34.7 million, partially offset by capital expenditures in the quarter of $7.8 million and net operating cash burn of $6.0 million.
    • On July 22, 2020 the Company reported that its RECONSM Clinical Study had completed target enrollment of 220 subjects.

    "We are encouraged by the performance of our commercial team and the demand for our products over the course of the quarter as surgery schedules opened and hospitals quickly moved to complete nerve repair procedures," commented Karen Zaderej, chairman, CEO, and president of Axogen. "We expect that most deferred nerve repair procedures will be scheduled by the end of the summer and believe that regional COVID-19 resurgence may continue to negatively impact the incidence of trauma and surgical procedure volumes in certain geographies. As a result, we remain measured in our outlook for the remainder of the year and expect that revenue in the third and fourth quarters will continue to trend below prior-year results. However, we are pleased with the resilience we have seen with our business and we believe that the strength of our balance sheet, along with our cost mitigation initiatives, will allow us to emerge from this pandemic-related downturn as a stronger, leaner organization on a path to profitability."

    Additional Operational and Business Highlights

    • Ended the second quarter with 112 direct sales representatives, an increase of three from last quarter, and up from 100 at the end of Q2 2019.
    • Active accounts in the second quarter were 789, an increase of 4% compared to 762 in the second quarter a year ago.
    • Ended the quarter with 126 peer-reviewed clinical publications featuring Axogen's nerve repair product portfolio.

    RECON Clinical Study Enrollment and Follow-Up

    RECON is a pivotal clinical study supporting the Company's Biologics License Application (BLA) for Avance® Nerve Graft. The study protocol requires a one-year follow-up assessment with an allowance for an additional three-month visit window. With the final subject enrolled in July of 2020, the last patient is expected to complete the study no later than October of 2021. The Company anticipates it will provide a preliminary report of study data in the second quarter of 2022 and expects to file the BLA in 2023.

    2020 Financial Guidance

    On April 1, 2020, the Company disclosed that it was suspending its 2020 annual financial guidance as previously provided on February 24, 2020 due to factors associated with COVID-19. At this date, the Company cannot predict the extent or duration of the impact of the COVID-19 pandemic on its financial results but expects the current environment will lead to revenues below the prior year in the third and fourth quarter.  

    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, 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.

    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. We also use the non-GAAP financial measures of Adjusted Net Loss and Adjusted Net Loss Per Common Share - basic and diluted which excludes non-cash stock compensation expense and loss on extinguishment of debt 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)
        
        
     June 30,December 31,
     20202019
    Assets   
    Current assets:   
    Cash and cash equivalents$75,320  $35,724 
    Restricted Cash 10,610   6,000 
    Short-term investments 24,009   60,786 
    Accounts receivable, net 14,049   16,944 
    Inventory 12,836   13,861 
    Prepaid expenses and other 3,405   1,706 
    Total current assets 140,229   135,021 
    Property and equipment, net 24,858   14,887 
    Operating lease right-of-use assets 3,138   3,133 
    Finance lease right-of-use assets 76   87 
    Intangible assets 1,660   1,515 
    Total assets$169,961  $154,643 
        
    Liabilities and Shareholders' Equity   
    Current liabilities:   
    Accounts payable and accrued expenses$12,451  $19,130 
    Current maturities of long term obligations 1,553   1,736 
    Contract liabilities, current 14   14 
    Total current liabilities 14,018   20,880 
    Long-term Debt, net of financing fees 31,960    
    Debt derivative liability 2,387    
    Common stock derivative option liability 176    
    Other long-term liabilities 1,660   1,610 
    Total liabilities 50,201   22,490 
    Shareholders' equity:   
    Common stock, $.01 par value; 100,000,000 shares authorized; 40,020,780 and 39,589,775 shares issued and outstanding 400   396 
    Additional paid-in capital 315,518   311,618 
    Accumulated deficit (196,158)  (179,861)
    Total shareholders' equity  119,760   132,153 
    Total liabilities and shareholders' equity$169,961  $154,643 



    AXOGEN, INC.
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
    Three and Six Months ended June 30, 2020 and 2019
    (unaudited)
            
     Three Months Ended Six Months Ended
     June 30, June 30, June 30, June 30,
     2020

     2019

     2020

     2019

    Revenues $22,116  $26,701  $46,377  $49,986 
    Cost of goods sold 5,605   4,244   10,421   7,958 
    Gross profit 16,511   22,457   35,956   42,028 
    Costs and expenses:       
    Sales and marketing 14,290   18,467   32,128   34,901 
    Research and development 4,071   4,282   8,685   8,421 
    General and administrative 6,404   7,380   11,906   16,581 
    Total costs and expenses 24,765   30,129   52,719   59,903 
    Loss from operations (8,254)  (7,672)  (16,763)  (17,875)
    Other income (expense):       
    Interest income 237   654   548   1,370 
    Interest expense (31)  (11)  (62)  (25)
    Interest expense – deferred financing costs           
    Loss on extinguishment of debt           
    Other expense (57)  6   (20)  4 
    Total other expense  149   649   466   1,349 
    Net loss$(8,105) $(7,023) $(16,297) $(16,526)
    Weighted average common shares outstanding – basic and diluted 39,823   39,175   39,761   39,055 
    Loss per common share – basic and diluted$(0.20) $(0.18) $(0.41) $(0.42)
            
    Adjusted net loss - non GAAP (5,883)  (3,738)  (13,519)  (9,741)
    Adjusted net loss per common share - basic and diluted$(0.15) $(0.10) $(0.34) $(0.25)
            
            
    AXOGEN, INC.
    RECONCILIATION OF GAAP FINANCIAL MEASURES TO NON-GAAP FINANCIAL MEASURES
    Three and Six Months ended June 30, 2020 and 2019
    (unaudited)
            
     Three Months Ended Six Months Ended
     June 30, June 30, June 30, June 30,
    2020

     2019

     2020

     2019

    Net loss$(8,105) $(7,023) $(16,297) $(16,526)
    Depreciation and amortization expense 346   264   665   514 
                    
    Investment income (237)  (654)  (548)  (1,370)
    Income tax 58   (12)  38   (12)
    Interest expense 31   11   62   25 
    EBITDA - non GAAP$(7,907) $(7,414) $(16,080) $(17,369)
            
    Non cash stock compensation expense 2,222   2,674   2,778   4,989 
    Litigation and related costs    611   -   1,796 
    Adjusted EBITDA - non GAAP$(5,685) $(4,129) $(13,302) $(10,584)
            
    Net loss$(8,105) $(7,023) $(16,297) $(16,526)
    Non cash stock compensation expense 2,222   2,674   2,778   4,989 
    Litigation and related costs    611      1,796 
    Adjusted Net Loss - non GAAP$(5,883) $(3,738) $(13,519) $(9,741)
                    
    Weighted average common shares outstanding – basic and diluted 39,823   39,175   39,761   39,055 
                    
    Adjusted net loss per common share - basic and diluted$(0.15) $(0.10) $(0.34) $(0.25)
            
            
    AXOGEN, INC.
    CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY
    Six Months Ended June 30, 2019 and 2018
    (unaudited)
            
     Common Stock

     Additional

    Paid-in

    Capital
     Accumulated

    Deficit
     Total

    Shareholders'

    Equity
    For the Three Months Ended June 30, 2020:       
    Balance at March 31, 2020$397  $311,850  $(188,053) $124,194 
    Net loss -   -   (8,105)  (8,105)
    Stock-based compensation -   2,222   -   2,222 
    Shares surrendered by employees to pay taxes -   (17)  -   (17)
    Exercise of stock options and employee stock purchase plan 3   1,463   -   1,466 
    Balance at June 30, 2020$400  $315,518  $(196,158) $119,760 
            
    For the Six Months Ended June 30, 2020:       
    Balance at December 31, 2019$396  $311,618  $(179,861) $132,153 
    Net loss -   -   (16,297)  (16,297)
    Stock-based compensation -   2,778   -   2,778 
    Issuance of restricted /performance service awards 1   (1)  -   - 
    Shares surrendered by employees to pay taxes (1)  (657)  -   (658)
    Exercise of stock options and employee stock purchase plan 4   1,780   -   1,784 
    Balance at June 30, 2020$400  $315,518  $(196,158) $119,760 
            
            
            
    For the Three Months Ended June 30, 2019:       
    Balance at March 31, 2019$391  $300,582  $(160,229) $140,743 
    Net loss -   -   (7,023)  (7,023)
    Stock-based compensation -   2,674   -   2,674 
    Exercise of stock options and employee stock purchase plan 2   1,563   -   1,565 
    Balance at June 30, 2019$393  $304,819  $(167,252) $137,959 
            
    For the Six Months Ended June 30, 2019:       
    Balance at December 31, 2018$389  $297,319  $(150,726) $146,982 
    Net loss -   -   (16,526)  (16,526)
    Stock-based compensation -   4,989   -   4,989 
    Exercise of stock options and employee stock purchase plan 4   2,511   -   2,515 
    Balance at June 30, 2019$393  $304,819  $(167,252) $137,960 



    AXOGEN, INC.
    CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
    Six Months ended June 30, 2020 and 2019
    (unaudited)
        
     Six Months Ended
     June 30, June 30,
     2020 2019
    Cash flows from operating activities:   
    Net loss$(16,297) $(16,526)
    Adjustments to reconcile net loss to net cash used in operating activities:   
    Depreciation 618   439 
    Amortization of right-of-use assets 802   891 
    Amortization of intangible assets 72   56 
    Provision for bad debt (115)  (159)
    Provision for inventory write down 1,624   (95)
    Change in investment gains and losses (141)  (602)
    Share-based compensation 2,778   4,989 
    Change in assets and liabilities:   
    Accounts receivable 3,010   (805)
    Inventory (600)  (1,510)
    Prepaid expenses and other (1,699)  (1,312)
    Accounts payable and accrued expenses (4,212)  816 
    Operating Lease Obligations (915)  (846)
    Cash paid for interest portion of Finance Leases -   (2)
    Contract and other liabilities (6)  (12)
    Net cash used in operating activities (15,081)  (14,678)
        
    Cash flows from investing activities:   
    Purchase of short-term investments (22,965)  (84,142)
    Purchase of property and equipment (13,183)  (1,685)
    Sale/Maturities of short-term investments 59,883   98,871 
    Cash payments for intangible assets (216)  (280)
    Net cash provided by/ (used for) investing activities 23,519   12,764 
        
    Cash flows from financing activities:   
    Proceeds from the issuance long term debt 35,000    
    Payments of debt issuance costs (350)   
    Payments for repurchase of common stock for employee tax withholding (658)   
    Cash paid for debt portion of finance leases (8)  (17)
    Proceeds from exercise of stock options and warrants 1,784   2,515 
    Net cash provided by financing activities 35,768   2,498 
        
    Net increase in cash, cash equivalents and restricted cash 44,206   584 
    Cash, cash equivalents and restricted cash, beginning of year 41,724   30,294 
    Cash, cash equivalents and restricted cash, end of period$85,930  $30,878 
        
    Supplemental disclosures of cash flow activity:   
    Cash paid for interest 23   25 
    Supplemental disclosure of non-cash investing and financing activities   
    Acquisition of fixed assets in accounts payable and accrued expenses 617   567 
    Right-of-use asset and operating lease liability 796   26 

    Primary Logo

    View Full Article Hide Full Article
  2. ALACHUA, Fla., July 29, 2020 (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 that Karen Zaderej, chairman, CEO, and president, will present at the Canaccord Genuity 40th Annual Growth Conference. The virtual presentation is scheduled for Wednesday, August 12, 2020 at 9:00 a.m. ET.

    The presentation 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…

    ALACHUA, Fla., July 29, 2020 (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 that Karen Zaderej, chairman, CEO, and president, will present at the Canaccord Genuity 40th Annual Growth Conference. The virtual presentation is scheduled for Wednesday, August 12, 2020 at 9:00 a.m. ET.

    The presentation 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

    Primary Logo

    View Full Article Hide Full Article
  3. ALACHUA, Fla., July 22, 2020 (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 that its phase 3 pivotal RECONSM Clinical Study supporting its Biologics License Application (BLA) submission for Avance Nerve Graft has reached its enrollment target of 220 subjects. RECON compares Avance Nerve Graft to manufactured conduits in digital nerve injuries with a primary endpoint of return of sensation and secondary endpoints for quality of life and patient satisfaction.

    "We are pleased to have reached this important milestone and appreciate the dedication and commitment of each of the participating study teams…

    ALACHUA, Fla., July 22, 2020 (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 that its phase 3 pivotal RECONSM Clinical Study supporting its Biologics License Application (BLA) submission for Avance Nerve Graft has reached its enrollment target of 220 subjects. RECON compares Avance Nerve Graft to manufactured conduits in digital nerve injuries with a primary endpoint of return of sensation and secondary endpoints for quality of life and patient satisfaction.

    "We are pleased to have reached this important milestone and appreciate the dedication and commitment of each of the participating study teams," commented Karen Zaderej, chairman, CEO, and president of Axogen. "Completing enrollment for the RECON Study is a critical step in transitioning our Avance Nerve Graft from classification as a section 361 HCT/P tissue product to a section 351 biological product."  

    The RECON Clinical Study protocol requires a one-year follow-up assessment with an additional three month visit window. With the final subject enrolled in July of 2020, the last patient is expected to complete the study no later than October of 2021. The company anticipates it will provide a preliminary report of trial data in the second quarter of 2022 and expects to file the BLA in 2023.   

    About the RECON Clinical Study

    Comparison of Processed Nerve Allograft and Collagen Nerve Cuffs for Peripheral Nerve Repair (RECON) is a multicenter, prospective, randomized, subject, and evaluator blinded comparative clinical study of nerve cuffs and Avance Nerve Graft evaluating recovery outcomes for the repair of nerve discontinuities. The study is designed to test for non-inferiority between the static two-point discrimination outcomes for Avance Nerve Graft and nerve cuffs.

    About Avance Nerve Graft

    Avance Nerve Graft is a biologically active off-the-shelf processed human nerve allograft for bridging severed peripheral nerves without the comorbidities associated with a second surgical site. Avance provides structural guidance for regenerating axons, and revascularizes and remodels into the patient's own tissue. It is available in a variety of lengths and diameters.

    In September 2018 the FDA granted a Regenerative Medicine Advance Therapy (RMAT) designation for Avance Nerve Graft. A regenerative medicine therapy is eligible for the designation if it is intended to treat, modify, reverse or cure a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the product has the potential to address unmet medical needs for such a disease or condition. The RMAT designation provides access to a streamlined approval process for regenerative medicine technologies and ensures continued informal meetings with the FDA in support of the BLA for Avance Nerve Graft.

    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 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

    Primary Logo

    View Full Article Hide Full Article
  4. ALACHUA, Fla., July 15, 2020 (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 second quarter 2020 financial results on Wednesday, August 5, 2020 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…

    ALACHUA, Fla., July 15, 2020 (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 second quarter 2020 financial results on Wednesday, August 5, 2020 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

    Primary Logo

    View Full Article Hide Full Article
  5. ALACHUA, Fla., July 01, 2020 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ:AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced a financing agreement with Oberland Capital and provided preliminary, estimated revenue for the second quarter ended June 30, 2020.

    Summary

    • Financing agreement provides up to $75.0 million in three tranches with interest only payments over seven years
    • $35.0 million drawn by the Company upon closing the agreement on June 30, 2020
    • Preliminary second quarter revenue is estimated to be at least $21 million, down 21% versus prior year

    "We are pleased to announce this new debt facility with Oberland Capital," noted Peter J. Mariani, chief financial officer…

    ALACHUA, Fla., July 01, 2020 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ:AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced a financing agreement with Oberland Capital and provided preliminary, estimated revenue for the second quarter ended June 30, 2020.

    Summary

    • Financing agreement provides up to $75.0 million in three tranches with interest only payments over seven years
    • $35.0 million drawn by the Company upon closing the agreement on June 30, 2020
    • Preliminary second quarter revenue is estimated to be at least $21 million, down 21% versus prior year

    "We are pleased to announce this new debt facility with Oberland Capital," noted Peter J. Mariani, chief financial officer of Axogen. "The addition of this facility further strengthens our balance sheet and supports the completion of our new Dayton biologic processing center in 2021. We believe that our strong balance sheet and continued commitment to our cost mitigation initiatives will allow us to emerge from the COVID-19 downturn a stronger, leaner organization and on a path to profitability."

    "I am very pleased with the Axogen team's commitment to our customers and the support we have provided as surgical schedules reopened during the quarter," commented Karen Zaderej, chairman, CEO, and president of Axogen. "Our pace of recovery continues to vary regionally based on the local impact of COVID-19. In many geographies we experienced a short-term surge in nerve repair cases as elective surgeries resumed and previously deferred procedures were completed. While we are encouraged by the ongoing recovery, we remain measured in our outlook for the remainder of the year as we believe most currently deferred procedures will be completed by end of summer and COVID-19 will continue to negatively impact the incidence of trauma and surgical procedure volumes. As a result, we expect third and fourth quarter revenue will remain below prior-year levels."

    Oberland Capital Financing Agreement

    The Company drew $35.0 million at closing on June 30, 2020 pursuant to its financing agreement with Oberland Capital. The facility allows for a second tranche of $15.0 million to be drawn at the Company's option upon achieving two consecutive quarters with revenue of at least $20.0 million. This second tranche can also be put to the Company at any time by Oberland Capital. The facility also allows a third tranche of $25.0 million to be drawn at the Company's option upon achieving two consecutive quarters with revenue of $28.0 million.

    The facility requires quarterly interest payments for seven years. Interest is calculated as 7.5% plus the greater of LIBOR or 2.0%. The interest rate at closing is 9.5%. An additional quarterly royalty payment on the first $70.0 million of annual revenue, will begin on September 30, 2021. This royalty structure results in approximately 1.0% per year of additional payments on the outstanding loan amount. Upon maturity, the Company will repay the principal balance and provide a make-whole payment calculated to generate an IRR to Oberland Capital of 11.5%, less the total of all quarterly interest and royalty payments previously paid to Oberland Capital.   

    Additionally, Oberland Capital has the right to purchase up to $3.5 million of common stock from Axogen at any time after closing of the financing agreement until the later of (i) the date all amounts due under the financing agreement are repaid and (ii) June 30, 2027. The purchase price of the common stock will be calculated as the 45-day moving average of the closing stock price on the day prior to the purchase.

    Additional details regarding the financing are available in the Company's Current Report on Form 8-K filed with the Securities and Exchange Commission this morning. The foregoing summary of certain terms of the financing agreement and related agreements is qualified in its entirety by reference to the full text of such agreements, which will be filed as exhibits to the Form 8-K.

    The results disclosed in this press release are preliminary. The Company will make its full report for the quarter ended June 30, 2020 on August 5, 2020 and host a conference call that same day.

    About Oberland Capital

    Oberland Capital, a private investment firm with over $2.25 billion in capital commitments since inception, is focused exclusively on investing in the global healthcare industry and specializes in flexible investment structures customized to meet the specific capital requirements and strategic objectives of its transaction partners. Oberland Capital's broad suite of financing solutions includes monetization of royalty streams, acquisition of future product revenues, creation of project-based financing structures, and investments in traditional debt and equity. With a combination of deep industry knowledge and extensive structured finance experience, the Oberland Capital team has a history of creating value for its transaction partners. The firm was founded in 2013 by Jean-Pierre Naegeli and Andrew Rubinstein.

    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 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



    Primary Logo

    View Full Article Hide Full Article
View All Axogen Inc. News