Axogen, Inc. (AXGN) News https://ir.axogeninc.com/rss The latest news released by Axogen, Inc. (AXGN) en-us Equisolve Investor Relations Suite https://d1io3yog0oux5.cloudfront.net/axogeninc/files/theme/images/logo-sm.png Axogen, Inc. (AXGN) News https://ir.axogeninc.com/rss 88 31 Axogen, Inc Reports 2023 Fourth Quarter and Full-Year Financial Results https://ir.axogeninc.com/news/detail/977/axogen-inc-reports-2023-fourth-quarter-and-full-year-financial-results Tue, 05 Mar 2024 07:00:00 -0500 https://ir.axogeninc.com/news/detail/977/axogen-inc-reports-2023-fourth-quarter-and-full-year-financial-results ALACHUA, Fla. and TAMPA, Fla., March 05, 2024 (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, 2023.

Fourth Quarter 2023 Financial Results and Business Highlights

  • Fourth quarter revenue was $42.9 million, an 18.7% increase compared to the fourth quarter of 2022.
  • The Company estimates that revenues from emergent trauma procedures represented approximately half of total revenues during the fourth quarter and grew mid-single digits versus the fourth quarter of 2022.
  • The Company estimates that revenues from scheduled non-trauma procedures represented approximately half of total revenues during the fourth quarter and grew more than 25% versus the fourth quarter of 2022.
  • Gross margin was 78.7% for the fourth quarter compared to 83.0% in the fourth quarter of 2022.
  • Net loss for the quarter was $3.9 million, or $0.09 per share, compared to net loss of $5.4 million, or $0.13 per share in the fourth quarter of 2022.
  • Adjusted net loss for the quarter was $2.6 million, or $0.06 per share, compared to adjusted net loss of $1.1 million, or $0.03 per share in the fourth quarter of 2022.
  • Adjusted EBITDA was $0.6 million for the quarter, compared to an adjusted EBITDA loss of $0.7 million in the fourth quarter of 2022.
  • The balance of all cash, cash equivalents, and investments on December 31, 2023 was $37.0 million, as compared to a balance of $38.6 million on September 30, 2023.

“We are pleased with our solid performance in the fourth quarter, and we are encouraged by the continued momentum we’ve seen in this first quarter,” commented Karen Zaderej, chairman, CEO, and president of Axogen, Inc. “Looking ahead, we remain focused on further penetrating core accounts by leveraging our growing body of clinical evidence and expanding use cases with our innovative new products and applications. Additionally, we are excited to expand our leadership position in nerve repair with the 2024 Q2 launch of Avive+ Sofit Tissue Matrix, supporting our mission of restoring nerve function and quality of life to patients with peripheral nerve injuries.”

Full-Year Financial Results and Business Highlights

  • Full-year 2023 revenue was $159.0 million, a 14.7% increase compared to 2022 revenue of $138.6 million.
  • Revenue from Core Accounts represents approximately 65% of total revenue.
  • Gross margin was 80.4% for the full-year, compared to 82.6% in 2022.
  • Net loss for the year was $21.7 million, or $0.51 per share, compared to net loss of $28.9 million, or $0.69 per share in 2022.
  • Adjusted net loss was $7.3 million for the full-year, or $0.17 per share, compared to 12.6 million for the full-year, or $0.30 per share in 2022.
  • Adjusted EBITDA loss was $1.1 million for the full-year, compared to an adjusted EBITDA loss of $9.3 million for 2022.
  • Core Accounts totaled 376, a 13.3% growth over the prior year level of 332.
  • Ended the fourth quarter with 116 direct sales representatives compared to 116 at the end of the third quarter and 115 on December 31, 2022.

Summary of Operational and Business Highlights

  • We recently completed a productive Pre-BLA meeting with FDA. We have aligned with FDA on a rolling submission process and the content of the modules for submission. We anticipate the filing to be completed in the third quarter of 2024. Subject to ongoing engagement with FDA, we currently believe the submission timetable will allow for a potential approval in mid-2025.
  • In August 2023, we began processing tissue in the new, state-of-the-art biologics processing facility, which provides for up to three times the previous capacity and was designed for long-term growth and expansion.
  • During 2023, we surpassed 100,000 Avance nerve graft implants since launch in 2007.
  • We are continuing to expand our offering in the nerve protection market with the national launch of Axoguard HA+ Nerve Protector™ in 2023 and expect to launch Avive+ Soft Tissue Matrix™ in the second quarter of 2024.
  • We launched Resensation® for implant-based reconstruction allowing us to access an additional 10-15% of the overall breast reconstruction market. As part of this launch, we have established a comprehensive training program to support the adoption of this innovative approach to bring sensation to more patients undergoing mastectomy.
  • We ended the year with 245 peer-reviewed clinical publications featuring Axogen’s nerve repair product portfolio.

2024 Financial Guidance

We expect revenue to be in the range of $177 million to $181 million, which represents an annual growth rate of approximately 11% to 14%. Additionally, we anticipate gross margin for the full year to be in the range of 76% to 79%.

Conference Call

The Company will host a conference call and webcast for the investment community today at 8:00 a.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 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 that are used across two primary application categories: scheduled, non-trauma procedures and emergent trauma procedures. Scheduled procedures are generally characterized as those where a patient is seeking relief from conditions caused by a nerve defect or surgical procedure. These procedures include providing sensation for women seeking breast reconstruction following a mastectomy, nerve reconstruction following the surgical removal of painful neuromas, oral and maxillofacial procedures, and nerve decompression. Emergent procedures are generally characterized as procedures resulting from injuries that are initially present in an ER. These procedures are typically referred to and completed by a specialist either immediately or within a few days following the initial injury.

Axogen’s product portfolio includes 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 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 HA+ Nerve Protector™, a porcine submucosa ECM base layer coated with a proprietary hyaluronate-alginate gel, a next-generation technology designed to enhance nerve gliding and provide short- and long-term protection for peripheral nerve injuries; and 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. The Axogen portfolio of products is available in the United States, Canada, Germany, the United Kingdom, Spain, South Korea, and several other countries.

For more information, visit www.axogeninc.com.

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. Forward-looking statements include the Company’s estimates regarding the revenues from scheduled non-trauma procedures and emergent trauma procedures as a portion of the total revenues, Ms. Zaderej’s statements on the Company’s future focus, the Company’s portfolio of clinical data supports the products’ efficacy, cost and time savings, the anticipated timing of the full BLA submission and our expectations that the BLA will be approved in mid-2025, the expected timing of the launch of Avive+ Soft Tissue Matrix, our expectations regarding our ability to access an additional 10-15% of the overall breast reconstruction market, as well as statements related to the 2024 financial outlook, including revenue range and gross margins. Actual results or events could differ materially from those described in any forward-looking statements as a result of various factors, including, without limitation, global supply chain issues, hospital staffing issues, product development, product potential, clinical outcomes, regulatory process and approvals, financial performance, sales growth, surgeon and product adoption, market awareness of our products, data validation, our visibility at and sponsorship of conferences and educational events, global business disruption caused by Russia’s invasion of Ukraine and related sanctions, recent geopolitical conflicts in the Middle East, potential disruptions due to management transitions, as well as those risk factors described under Part I, Item 1A., “Risk Factors,” of our Annual Report on Form 10-K for the most recently ended fiscal year. 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.

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 the non-GAAP measures to the most directly comparable financial measures calculated and presented in accordance with GAAP 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, the Company’s cash available for operations, and the Company’s ability to meet future capital expenditure and working capital requirements.

Contact:
Axogen, Inc.
Harold D. Tamayo, Vice President of Finance and Investor Relations
htamayo@axogeninc.com


AXOGEN, INC.
CONSOLIDATED BALANCE SHEETS
(unaudited)
December 31, 2023 and 2022
(In Thousands, Except Share and Per Share Amounts)
 
December 31, 2023   December 31, 2022
Assets  
Current assets:  
Cash and cash equivalents $ 31,024     $ 15,284  
Restricted cash   6,002       6,251  
Investments         33,505  
Accounts receivable, net of allowance for doubtful accounts of $337 and $650, respectively   25,147       22,186  
Inventory   23,020       18,905  
Prepaid expenses and other   2,811       1,944  
Total current assets   88,004       98,075  
Property and equipment, net   88,730       79,294  
Operating lease right-of-use assets   15,562       14,369  
Intangible assets, net   4,531       3,649  
Total assets $ 196,827     $ 195,387  
     
Liabilities and shareholders’ equity      
Current liabilities:      
Accounts payable and accrued expenses   28,883       22,443  
Current maturities of long-term lease obligations   1,547       1,310  
Total current liabilities   30,430       23,753  
     
Long-term debt, net of debt discount and financing fees   46,603       45,712  
Long-term lease obligations   21,142       20,405  
Debt derivative liabilities   2,987       4,518  
Total liabilities   101,162       94,388  
     
Commitments and contingencies - see Note 14      
     
Shareholders’ equity:      
Common stock, $0.01 par value per share; 100,000,000 shares authorized; 43,124,496 and 42,445,517 shares issued and outstanding   431       424  
Additional paid-in capital   376,530       360,155  
Accumulated deficit   (281,296 )     (259,580 )
Total shareholders’ equity   95,665       100,999  
Total liabilities and shareholders’ equity $ 196,827     $ 195,387  

AXOGEN, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
Years ended December 31, 2023 , 2022 and 2021
(In Thousands, Except Share and Per Share Amounts)
 
  2023       2022       2021  
Revenues $ 159,012     $ 138,584     $ 127,358  
Cost of goods sold   31,138       24,147       22,931  
Gross profit   127,874       114,437       104,427  
Costs and expenses:          
Sales and marketing   86,060       80,228       73,328  
Research and development   28,333       27,158       24,177  
General and administrative   34,943       36,758       32,338  
Total costs and expenses   149,336       144,144       129,843  
Loss from operations   (21,462 )     (29,707 )     (25,416 )
Other (expense) income:          
Investment income   1,487       569       93  
Interest expense   (2,835 )     (624 )     (1,356 )
Change in fair value of derivatives   1,531       1,044       (28 )
Other expense   (437 )     (230 )     (278 )
Total other income (expense), net   (254 )     759       (1,569 )
Net loss $ (21,716 )   $ (28,948 )   $ (26,985 )
           
Weighted average common shares outstanding — basic and diluted   42,879,000       42,083,000       41,215,000  
Loss per common share — basic and diluted $ (0.51 )   $ (0.69 )   $ (0.65 )


AXOGEN, Inc.
RECONCILIATION OF GAAP FINANCIAL MEASURES TO NON-GAAP FINANCIAL MEASURES
Three Months and Year Ended December 31, 2023 and 2022
(unaudited)
(In Thousands, Except Per Share Amounts)​
 
    Three Months Ended   Year Ended
    December 31,
2023
  December 31,
2022
  December 31,
2023
  December 31,
2022
                 
Net loss   $ (3,893 )   $ (5,415 )   $ (21,716 )   $ (28,948 )
Depreciation and amortization expense     1,617       713       4,491       3,093  
Investment income     (336 )     (397 )     (1,487 )     (569 )
Income tax expense     9       125           189  
Interest expense     1,843       (40 )     2,835       624  
EBITDA - non GAAP   $ (760 )   $ (5,014 )   $ (15,538 )   $ (25,611 )
                 
Non cash stock-based compensation expense     1,327       4,154       14,418       15,591  
Litigation and related costs           177             761  
Adjusted EBITDA - non GAAP   $ 567     $ (683 )     (1,120 )   $ (9,259 )
                 
Net loss   $ (3,893 )   $ (5,415 )   $ (21,716 )   $ (28,948 )
Non cash stock-based compensation expense     1,327       4,154       14,418       15,591  
Litigation and related costs           177             761  
Adjusted net loss - non GAAP   $ (2,566 )   $ (1,083 )   $ (7,298 )   $ (12,596 )
                 
Weighted average common shares outstanding basic and diluted     43,048,446       42,306,012       42,878,542       42,083,125  
                 
Loss per common share — basic and diluted   $ (0.09 )   $ (0.13 )   $ (0.51 )   $ (0.69 )
Non cash stock-based compensation expense   $ 0.03     $ 0.10     $ 0.34     $ 0.37  
Litigation and related costs   $     $     $     $ 0.02  
Adjusted net loss per common share - basis and diluted - non GAAP   $ (0.06 )   $ (0.03 )   $ (0.17 )   $ (0.30 )
                 

 

AXOGEN, INC.
CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY
Years ended December 31, 2023, 2022 and 2021
(In Thousands)
Common Stock   Additional
Paid-in
Capital
  Accumulated
Deficit
  Total
Shareholders’
Equity
Shares     Amount      
Balance, December 31, 2020 40,619     $ 406     $ 326,390     $ (203,647 )   $ 123,149  
                     
Stock-based compensation             10,919             10,919  
Issuance of restricted and performance stock units 254       2       (2 )            
Shares surrendered by employees to pay tax withholdings                          
Exercise of stock options and employee stock purchase plan 864       9       5,458             5,467  
Net loss                   (26,985 )     (26,985 )
                     
Balance, December 31, 2021 41,737       417       342,765       (230,632 )     112,550  
                     
Stock-based compensation             15,591             15,591  
Issuance of restricted and performance stock units 343       3       (3 )            
Exercise of stock options and employee stock purchase plan 365       4       1,802             1,806  
Net loss                   (28,948 )     (28,948 )
                   
Balance, December 31, 2022 42,445       424       360,155       (259,580 )     100,999  
                   
Stock-based compensation             14,418             14,418  
Issuance of restricted and performance stock units 369       4       (4 )            
Exercise of stock options and employee stock purchase plan 310       3       1,961             1,964  
Net loss                 (21,716 )     (21,716 )
                     
Balance, December 31, 2023 43,124     $ 431     $ 376,530     $ (281,296 )   $ 95,665  

 

AXOGEN, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
Years ended December 31, 2023, 2022 and 2021
(In Thousands)
 
  2023       2022       2021  
Cash flows from operating activities:          
Net loss $ (21,716 )   $ (28,948 )   $ (26,985 )
Adjustments to reconcile net loss to net cash used in operating activities:          
Depreciation   4,218       2,827       2,744  
Amortization of right-of-use assets   1,062       1,761       1,795  
Amortization of intangible assets   273       265       202  
Amortization of debt discount and deferred financing fees   891       891       831  
Loss on disposal of equipment   56              
Loss on extinguishment of debt          
Provision for bad debt   (271 )     612       (41 )
Provision for inventory write-down   1,939       1,769       3,314  
Investment losses (gains)   (666 )     (228 )     68  
Change in fair value of derivatives   (1,531 )     (1,044 )     28  
Stock-based compensation   14,418       15,591       10,919  
Change in operating assets and liabilities:          
Accounts receivable   (2,691 )     (4,639 )     (499 )
Inventory   (6,054 )     (3,656 )     (7,478 )
Prepaid expenses and other   (867 )     (84 )     2,435  
Accounts payable and accrued expenses   6,509       660       (270 )
Operating lease obligations   (1,269 )     (1,841 )     (463 )
Cash paid for interest portion of finance leases   (3 )     (2 )     (2 )
Contract and other liabilities   (14 )           (3 )
Net cash used in operating activities   (5,716 )     (16,066 )     (13,405 )
           
Cash flows from investing activities:          
Purchase of property and equipment   (13,872 )     (20,078 )     (27,811 )
Economic development grant proceeds               950  
Purchase of investments   (10,203 )     (39,247 )     (68,699 )
Proceeds from sale of investments   44,374       57,300       72,500  
Cash payments for intangible assets   (1,046 )     (1,175 )     (589 )
Net cash provided by (used in) investing activities   19,253       (3,200 )     (23,649 )
           
Cash flows from financing activities:          
Proceeds from issuance of long-term debt               15,000  
Cash paid for debt portion of finance leases   (10 )     (12 )     (15 )
Proceeds from exercise of stock options and ESPP stock purchases   1,964       1,806       5,467  
Net cash provided by financing activities   1,954       1,794       20,452  
Net increase (decrease) in cash, cash equivalents, and restricted cash   15,491       (17,472 )     (16,602 )
Cash, cash equivalents, and restricted cash, beginning of period   21,535       39,007       55,609  
Cash, cash equivalents, and restricted cash, end of period $ 37,026     $ 21,535     $ 39,007  

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Source: Axogen, Inc. ]]>
Axogen, Inc. to Report 2023 Fourth Quarter and Full-Year Financial Results on March 5, 2024 https://ir.axogeninc.com/news/detail/976/axogen-inc-to-report-2023-fourth-quarter-and-full-year-financial-results-on-march-5-2024 Tue, 13 Feb 2024 16:30:00 -0500 https://ir.axogeninc.com/news/detail/976/axogen-inc-to-report-2023-fourth-quarter-and-full-year-financial-results-on-march-5-2024 ALACHUA, Fla. and TAMPA, Fla., Feb. 13, 2024 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced that it will report 2023 fourth quarter and full-year financial results on Tuesday, March 5, 2024, before the market opens. Axogen management will host an investment-community conference call and webcast at 8 a.m. ET following the release.

Investors interested in participating in the conference call by phone may do so by dialing toll free at (877) 407-0993 or using 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 that are used across two primary application categories: scheduled, non-trauma procedures and emergent trauma procedures. Scheduled procedures are generally characterized as those where a patient is seeking relief from conditions caused by a nerve defect or surgical procedure. These procedures include providing sensation for women seeking breast reconstruction following a mastectomy, nerve reconstruction following the surgical removal of painful neuromas, oral and maxillofacial procedures, and nerve decompression. Emergent procedures are generally characterized as procedures resulting from injuries that are initially present in an ER. These procedures are typically referred to and completed by a specialist either immediately or within a few days following the initial injury.

Axogen’s product portfolio includes 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 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 HA+ Nerve Protector™, a porcine submucosa ECM base layer coated with a proprietary hyaluronate-alginate gel, a next-generation technology designed to enhance nerve gliding and provide short- and long-term protection for peripheral nerve injuries; and 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. The Axogen portfolio of products is available in the United States, Canada, Germany, the United Kingdom, Spain, South Korea, and several other countries.

For more information, visit www.axogeninc.com  

Contact:
Axogen, Inc.
Harold D. Tamayo, Vice President of Finance and Investor Relations
htamayo@axogeninc.com


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Source: Axogen, Inc. ]]>
Company Reports Inducement Grants Under Nasdaq Listing Rule 5635(C)(4) https://ir.axogeninc.com/news/detail/975/company-reports-inducement-grants-under-nasdaq-listing-rule-5635c4 Fri, 02 Feb 2024 16:15:00 -0500 https://ir.axogeninc.com/news/detail/975/company-reports-inducement-grants-under-nasdaq-listing-rule-5635c4 ALACHUA, Fla. and TAMPA, Fla., Feb. 02, 2024 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced making Inducement Grants Under NASDAQ Listing Rule 5635(c)(4) in connection with the employment and appointment of John Manning to the position of Area Vice President of Sales. Mr. Manning will report to Doris Quackenbush, Vice President of Sales.

In connection with the commencement of his employment on January 22, 2024, and as a material inducement of employment, Mr. Manning was awarded an equity grant on February 1, 2024, consisting of (i) non-qualified stock options to purchase 18,700 shares of the Company’s common stock and (ii) non-qualified restricted stock units (“RSUs”) representing 10,000 shares of the Company’s common stock. The stock options have an exercise price of $9.75 per share, a 10-year term, and will vest over a four-year period, with 50% vesting after the second year and 12.5% of the total shares granted vesting every six months thereafter for the next two years. The RSUs are subject to vesting over 4 years, with 50% vesting after the second year and 25% of the total shares granted vesting every year thereafter for the next two years.

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 that are used across two primary application categories: scheduled, non-trauma procedures and emergent trauma procedures. Scheduled procedures are generally characterized as those where a patient is seeking relief from conditions caused by a nerve defect or surgical procedure. These procedures include providing sensation for women seeking breast reconstruction following a mastectomy, nerve reconstruction following the surgical removal of painful neuromas, oral and maxillofacial procedures, and nerve decompression. Emergent procedures are generally characterized as procedures resulting from injuries that are initially present in an ER. These procedures are typically referred to and completed by a specialist either immediately or within a few days following the initial injury.

Axogen’s product portfolio includes 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 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 HA+ Nerve Protector™, a porcine submucosa ECM base layer coated with a proprietary hyaluronate-alginate gel, a next-generation technology designed to enhance nerve gliding and provide short- and long-term protection for peripheral nerve injuries; and 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. The Axogen portfolio of products is available in the United States, Canada, Germany, the United Kingdom, Spain, South Korea, and several other countries.

For more information, visit www.axogeninc.com  

Contact:

Axogen, Inc.
Harold D. Tamayo, Vice President of Finance and Investor Relations
htamayo@axogeninc.com


Primary Logo

Source: Axogen, Inc. ]]>
Axogen, Inc. Announces Positive Topline Results from REPOSE, a Prospective, Randomized Clinical Trial of Axoguard Nerve Cap https://ir.axogeninc.com/news/detail/974/axogen-inc-announces-positive-topline-results-from-repose-a-prospective-randomized-clinical-trial-of-axoguard-nerve-cap Thu, 18 Jan 2024 17:00:00 -0500 https://ir.axogeninc.com/news/detail/974/axogen-inc-announces-positive-topline-results-from-repose-a-prospective-randomized-clinical-trial-of-axoguard-nerve-cap REPOSE® met its primary endpoint of non-inferiority between the pain visual analog scale outcomes for neurectomy with Axoguard Nerve Cap® vs. standard-of-care neurectomy at Month 12.

Axoguard Nerve Cap demonstrated statistical superiority vs. standard-of-care neurectomy in the reduction of total pain reported by participants over the course of follow-up.

ALACHUA, Fla. and TAMPA, Fla., Jan. 18, 2024 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced positive topline results from its REPOSE clinical study comparing standard-of-care neurectomy of symptomatic neuroma to neurectomy and protection of the terminated nerve end with Axoguard Nerve Cap. The post-marketing study met its primary endpoint for reduction in pain as measured by visual analog scale (p-value <0.05).

Additional data analysis found that over the 12-month course of follow-up, the Axoguard Nerve Cap group demonstrated statistical superiority for reduction in the total pain reported by participants compared to the standard-of-care neurectomy group (p-value <0.05).

“We are pleased with the study outcomes and the quality of data gathered in the REPOSE study,” said Lead Investigator Craig Thomajan, DPM, Founder and Managing Partner of Austin Foot & Ankle Specialists. “The data suggest that the addition of Axoguard Nerve Cap to isolate and protect the peripheral nerve ends following a neurectomy is a better treatment option than standard-of-care neurectomy alone for managing symptomatic neuroma pain.”

“This data builds on our body of clinical evidence that supports increased adoption of Axoguard Nerve Cap amongst surgeons and their patients who are seeking solutions that may enhance quality of life following nerve resection to manage chronic neuropathic pain,” commented Karen Zaderej, chairman, CEO, and president. “I am grateful to all study participants and investigators, as well as the Axogen team for their unwavering commitment to delivering improved solutions for patients suffering from peripheral nerve injuries.

About REPOSE®

REPOSE is a multicenter, prospective, randomized, subject blinded comparative clinical trial of standard neurectomy and neurectomy followed by placement of Axoguard Nerve Cap, evaluating recovery outcomes for the treatment of symptomatic neuroma. The post-market study is designed to test for non-inferiority between the pain visual analog scale outcomes for neurectomy with Axoguard Nerve Cap and standard neurectomy. The study design also allows for a sequential test for superiority of neurectomy with Axoguard Nerve Cap, following the non-inferiority analysis.

About Axoguard Nerve Cap®

Axoguard Nerve Cap is a proprietary surgical implant derived from porcine submucosal extracellular matrix that is remodeled during healing and is used to isolate and protect a peripheral nerve end from the surrounding environment to reduce symptomatic or painful neuroma development.

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 that are used across two primary application categories: scheduled, non-trauma procedures and emergent trauma procedures. Scheduled procedures are generally characterized as those where a patient is seeking relief from conditions caused by a nerve defect or surgical procedure. These procedures include providing sensation for women seeking breast reconstruction following a mastectomy, nerve reconstruction following the surgical removal of painful neuromas, oral and maxillofacial procedures, and nerve decompression. Emergent procedures are generally characterized as procedures resulting from injuries that are initially present in an ER. These procedures are typically referred to and completed by a specialist either immediately or within a few days following the initial injury.

Axogen’s product portfolio includes 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 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 HA+ Nerve Protector™, a porcine submucosa ECM base layer coated with a proprietary hyaluronate-alginate gel, a next-generation technology designed to enhance nerve gliding and provide short- and long-term protection for peripheral nerve injuries; and 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. The Axogen portfolio of products is available in the United States, Canada, Germany, the 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. Forward-looking statements include the outcome of the REPOSE Clinical study of Axoguard Nerve Cap after full data is available, statements and expectations regarding the adoption of Axoguard Nerve Cap among surgeons and their patients, and statements regarding the use of Axoguard Nerve Cap following a neurectomy being a better treatment option for managing chronic neuropathic pain as compared to standard neurectomy." Actual results or events could differ materially from those described in any forward-looking statements as a result of various factors, including, without limitation, potential disruptions caused by leadership transitions, global supply chain issues, record inflation, hospital staffing issues, product development, product potential, expected clinical enrollment timing and outcomes, regulatory process and approvals, APC transition timing and expense, financial performance, sales growth, surgeon and product adoption, market awareness of our products, data validation, our visibility at and sponsorship of conferences and educational events, global business disruption caused by Russia’s invasion of Ukraine and related sanctions, recent geopolitical conflicts in the Middle East, as well as those risk factors described under Part I, Item 1A., “Risk Factors,” of our Annual Report on Form 10-K for the most recently ended fiscal year and Part II, Item 1A., “Risk Factors,” for our Quarterly Report on Form 10-Q for the most recently ended fiscal quarter. 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.

For more information, visit www.axogeninc.com  

Contact:
Axogen, Inc.
Harold D. Tamayo, Vice President of Finance and Investor Relations
htamayo@axogeninc.com


Primary Logo

Source: Axogen, Inc. ]]>
Axogen Reports Preliminary Unaudited Revenue for Fourth Quarter and Full-Year 2023 https://ir.axogeninc.com/news/detail/973/axogen-reports-preliminary-unaudited-revenue-for-fourth-quarter-and-full-year-2023 Thu, 04 Jan 2024 16:45:00 -0500 https://ir.axogeninc.com/news/detail/973/axogen-reports-preliminary-unaudited-revenue-for-fourth-quarter-and-full-year-2023 ALACHUA, Fla. and TAMPA, Fla., Jan. 04, 2024 (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 2023 revenue.

Preliminary Unaudited Fourth Quarter and Year-End Performance and Business Highlights

  • Fourth quarter revenue is expected to be approximately $42.7 million, which represents an 18% increase over the fourth-quarter of 2022 driven by solid performance across the product portfolio.
  • Full-year 2023 revenue is expected to be approximately $158.8 million, which represents a 15% increase over the full-year of 2022. This growth is attributed to the effective implementation of sales strategies and the performance of our diverse product portfolio including the launch of Axoguard HA+ Nerve ProtectorTM, mirroring the positive trends observed in our fourth-quarter results.
  • Revenue from Core Accounts for the full-year 2023 is expected to represent approximately 65% of revenue. We ended the fourth quarter with Core Accounts at 375, an increase of 13% over prior year, indicating solid growth and strengthened relationships within this important customer base.
  • At the end of the fourth quarter, our team demonstrated efficient sales growth with 116 direct sales representatives, compared to the 115 representatives recorded as of December 31, 2022.
  • In 2023, we achieved a significant milestone by surpassing 100,000 Avance® Nerve Graft implants since its launch. This achievement reflects the growing trust and preference for Avance in the healthcare community.
  • We continue our commitment to drive innovation by the introduction of Axoguard HA+ Nerve ProtectorTM and the strategic roll-out in Q2 of 2024 of Avive+ Soft Tissue MatrixTM, a resorbable nerve protection product that provides temporary protection and tissue separation during the critical phase of healing for nerve injuries. This application was previously addressed by Avive Soft Tissue membrane. These initiatives reflect our ongoing dedication to advancing our product offerings and enhancing value for our patients and stakeholders.

"We are pleased with our fourth-quarter and full-year 2023 performance. Growth in the quarter was driven by improved commercial execution across our products and their applications,” commented Karen Zaderej, Axogen's Chairman, CEO, and President. “As we enter 2024, we continue to fortify our foundation by driving innovation in nerve protection with the planned market expansion for Axoguard HA+TM, the roll-out for Avive+TM, and our BLA submission for Avance, which remains on track for the end of the first half of 2024. In 2024, we look forward to continuing to enhance patients’ quality of life with our product portfolio and delivering value for our stakeholders through our drive toward being cash flow positive and profitable.”

Updated 2023 Financial Guidance

The Company now expects full-year 2023 revenue to be at the high end of the $154 million to $159 million guidance range provided earlier in the year. This represents annual growth of approximately 15%. The Company continues to believe that gross margin for the full year 2023 will be approximately 80%.

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, 2023, on March 5, 2024. 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 that are used across two primary application categories: scheduled, non-trauma procedures and emergent trauma procedures. Scheduled procedures are generally characterized as those where a patient is seeking relief from conditions caused by a nerve defect or surgical procedure. These procedures include providing sensation for women seeking breast reconstruction following a mastectomy, nerve reconstruction following the surgical removal of painful neuromas, oral and maxillofacial procedures, and nerve decompression. Emergent procedures are generally characterized as procedures resulting from injuries that initially present in an ER. These procedures are typically referred to and completed by a specialist either immediately or within a few days following the initial injury.

Axogen’s product portfolio includes 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 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 HA+ Nerve Protector™, a porcine submucosa ECM base layer coated with a proprietary hyaluronate-alginate gel, a next-generation technology designed to enhance nerve gliding and provide short- and long-term protection for peripheral nerve injuries; and 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. The Axogen portfolio of products is available in the United States, Canada, Germany, the 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. Forward-looking statements include statements regarding our preliminary, unaudited fourth quarter and full year 2023 performance, the timing of the introduction of the Axoguard HA+ Nerve Protector, timing of the submission of the BLA, development and market launch timetable for Avive+, as well as statements under the subheading "Updated 2023 Financial Guidance." Actual results or events could differ materially from those described in any forward-looking statements as a result of various factors, including, without limitation, potential disruptions caused by leadership transitions, global supply chain issues, record inflation, hospital staffing issues, product development, product potential, expected clinical enrollment timing and outcomes, regulatory process and approvals, APC transition timing and expense, financial performance, sales growth, surgeon and product adoption, market awareness of our products, data validation, our visibility at and sponsorship of conferences and educational events, global business disruption caused by Russia’s invasion of Ukraine and related sanctions, recent geopolitical conflicts in the Middle East, as well as those risk factors described under Part I, Item 1A., “Risk Factors,” of our Annual Report on Form 10-K for the most recently ended fiscal year and Part II, Item 1A., “Risk Factors,” for our Quarterly Report on Form 10-Q for the most recently ended fiscal quarter. 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.

For more information, visit www.axogeninc.com

Contact:
Axogen, Inc.
Harold D. Tamayo, VP of Finance and Investor Relations
htamayo@axogeninc.com


Primary Logo

Source: Axogen, Inc. ]]>
Axogen Announces Plan for Leadership Transition with CEO Karen Zaderej to Retire from Company by January 2025 https://ir.axogeninc.com/news/detail/972/axogen-announces-plan-for-leadership-transition-with-ceo-karen-zaderej-to-retire-from-company-by-january-2025 Thu, 04 Jan 2024 16:40:00 -0500 https://ir.axogeninc.com/news/detail/972/axogen-announces-plan-for-leadership-transition-with-ceo-karen-zaderej-to-retire-from-company-by-january-2025 ALACHUA and TAMPA, Fla., Jan. 04, 2024 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced that President and Chief Executive Officer (CEO) Karen Zaderej plans to retire from the Company by January 2025. The Company’s Board of Directors will retain an executive recruitment firm to manage a search for her successor. When a new CEO is in place, Ms. Zaderej will step down from her executive post and Board duties and continue as a consultant to Axogen for an additional nine months to support the leadership transition and the submission process of the Biologics License Application (BLA) for Avance® Nerve Graft. While the transition is planned to be no later than Jan. 5, 2025, it could occur sooner depending on the timing of a new CEO appointment.

Ms. Zaderej has led the transformation of Axogen from a small start-up company to a category leader in the growing market of nerve repair. As one of Axogen’s first employees, Ms. Zaderej initially oversaw the Company’s sales and marketing function before moving into the role of Chief Operating Officer and then CEO in 2010. Under her leadership, Axogen has built awareness of the patient quality of life impact related to nerve damage and has created the market for nerve repair. She has driven the diversification of Axogen’s portfolio to address nerve connection, protection, and termination with multiple nerve repair product launches and has led the work to develop a unique regulatory strategy for Avance with a planned filing of a BLA in the second quarter of this year.

Ms. Zaderej stated, “Axogen is in a strong position as we start 2024. As announced separately today, we have promoted several key team members to new leadership roles that will be important in the next chapter of the Company. We are also reporting preliminary fourth quarter and full-year 2023 revenue of approximately $42.7 million and $158.8 million, demonstrating year-over-year growth of 18% and 15%, respectively. I am proud of the accomplishments of our team and know that Axogen is positioned well for continued growth. While I will retire from my roles on the executive team and Board, I firmly believe in the talent and strength of the team to continue to improve patient lives and drive long-term success at Axogen.”

Amy Wendell, Axogen’s Lead Director, added, “The Board of Directors recognizes and appreciates Karen’s contributions to the building of the Company as well as the entire peripheral nerve repair market. She has had an integral role throughout every stage of Axogen’s development. With the BLA submission for Avance® Nerve Graft nearing completion and the Company continuing to demonstrate steady revenue increases year over year, we will look to bring on board a CEO who will help accelerate Axogen’s next phase of commercial growth and move towards profitability. The timing is right for this as the Company begins to shift its focus in 2024 to what will be a post-BLA commercial expansion strategy.”

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 that are used across two primary application categories: scheduled, non-trauma procedures and emergent trauma procedures. Scheduled procedures are generally characterized as those where a patient is seeking relief from conditions caused by a nerve defect or surgical procedure. These procedures include providing sensation for women seeking breast reconstruction following a mastectomy, nerve reconstruction following the surgical removal of painful neuromas, oral and maxillofacial procedures, and nerve decompression. Emergent procedures are generally characterized as procedures resulting from injuries that initially present in an ER. These procedures are typically referred to and completed by a specialist either immediately or within a few days following the initial injury.

Axogen’s product portfolio includes 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 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 HA+ Nerve Protector™, a porcine submucosa ECM base layer coated with a proprietary hyaluronate-alginate gel, a next-generation technology designed to enhance nerve gliding and provide short- and long-term protection for peripheral nerve injuries; and 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. The Axogen portfolio of products is available in the United States, Canada, Germany, the 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. Forward-looking statements include the timing of Ms. Zaderej’s retirement, the timing of the CEO search, the ability to find suitable CEO candidates, the ability of the new CEO to accelerate the Company’s commercial growth and focus on the move towards profitability, the effectiveness of the Company’s new leadership team, the timing of the BLA submission and the Company’s preliminary fourth quarter and full-year 2023 revenue and growth. Actual results or events could differ materially from those described in any forward-looking statements as a result of various factors, including, without limitation, potential disruptions caused by leadership transitions, global supply chain issues, record inflation, hospital staffing issues, product development, product potential, expected clinical enrollment timing and outcomes, regulatory process and approvals, processing facility transition timing and expense, financial performance, sales growth, surgeon and product adoption, market awareness of our products, data validation, our visibility at and sponsorship of conferences and educational events, global business disruption caused by Russia’s invasion of Ukraine and related sanctions, recent geopolitical conflicts in the Middle East, as well as those risk factors described under Part I, Item 1A., “Risk Factors,” of our Annual Report on Form 10-K for the most recently ended fiscal year and Part II, Item 1A., “Risk Factors,” for our Quarterly Report on Form 10-Q for the most recently ended fiscal quarter. 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.

For more information, visit www.axogeninc.com.

Contact:

Axogen, Inc.

Harold D. Tamayo, VP of Finance and Investor Relations

htamayo@axogeninc.com


Primary Logo

Source: Axogen, Inc. ]]>
Axogen Announces Promotions on Research and Development Team https://ir.axogeninc.com/news/detail/971/axogen-announces-promotions-on-research-and-development-team Thu, 04 Jan 2024 16:35:00 -0500 https://ir.axogeninc.com/news/detail/971/axogen-announces-promotions-on-research-and-development-team Company Also Announces Departure of Angelo Scopelianos, Ph.D.

ALACHUA, Fla. and TAMPA, Fla., Jan. 04, 2024 (GLOBE NEWSWIRE) --  Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced the promotions of three research and development team members. The promotions are:

  • Erick DeVinney to Chief Innovation Officer

    Mr. DeVinney joined Axogen in April of 2007 as Director of Clinical Research. During his tenure, he has held positions of progressive responsibility in Clinical Research, Research and Development, Product Development, Medical Education, and Medical Affairs. Mr. DeVinney has more than 16 years of experience driving innovation in peripheral nerve injury diagnosis and repair, including clinical and regulatory development strategies, portfolio development, and scientific thought leadership. He has a diverse background, including academic research and the development of tissue technologies, medical devices, pharmaceuticals, and biologics. Mr. DeVinney has been involved in research at the Virginia Commonwealth University Medical College of Virginia Hospitals, University of Utrecht, National Clinical Research, PRA International, and Angiotech. He has been involved in the successful submission of eight IDE or NDA applications, as well as numerous 510(k)s. Mr. DeVinney also serves as a Board Member for the Global Nerve Foundation. He has a B.S. degree in Chemistry from Virginia Commonwealth University.
  • Ivica Ducic, M.D., Ph.D., to Chief Medical Officer 

    Dr. Ducic joined Axogen as Medical Director in January 2017. He is a board-certified plastic surgeon, with additional training and expertise in peripheral nerve surgery. He received his medical degree in 1991 from the University of Zagreb School of Medicine (Croatia, Europe), and a Ph.D. degree in 1995 in neuroscience. Upon completing plastic surgery training at Georgetown University Hospital in 2002, he entered a one-year peripheral nerve surgery fellowship. He then joined the full-time faculty practice at Georgetown University Hospital Department of Plastic Surgery in August 2003, where he served as a professor of plastic surgery and neurosurgery. In 2014, Dr. Ducic established his own practice, the Washington Nerve Institute in McLean, Virginia. Among his many accomplishments, Dr. Ducic is the Past-President of the American Society for Peripheral Nerve, has served on many committees, published more than 100 peer-reviewed papers, authored 17 book chapters, and has been a prolific invited educator both nationally and internationally on the diagnosis and treatment of peripheral nerve injury. During his past seven years at Axogen, Dr. Ducic has been an instrumental leader in the development of new technologies, applicable surgical techniques, surgeon education, as well as providing strategic guidance for the core company mission – improving the quality of life of patients with nerve injuries.
  • Stacy Arnold to Vice President of Product Development and Clinical Research   

    Ms. Arnold has served as Vice President of Clinical Research for Axogen since June 2019. She initially joined Axogen in April 2018 as Vice President of Program Management. She has been leading the research, development, and execution of clinical strategies to strengthen and advance the body of evidence for new technologies and clinical applications to restore nerve function and quality of life to patients with peripheral nerve injuries. Ms. Arnold previously served as Senior Director of R&D and Program Management at Artivion (formerly CryoLife), driving global innovation and new product development of medical devices, biologics, and tissue technologies, while leading successful program management processes and business strategies to drive growth and deliver shareholder value. Ms. Arnold serves as a Board Member on Mercer University’s National Engineering Advisory Board. She has an M.S. in Engineering from the University of Toledo and a B.S. in Biomedical Engineering from Mercer University. She also holds a global Project Management Professional Certification from the Project Management Institute.

In addition, the Company is announcing the departure of Angelo Scopelianos, Ph.D., Axogen’s Chief Research and Development Officer, in the first quarter of 2024.

“We want to thank Angelo for his contributions in new programs that led to innovations like the launch of Axoguard HA+ Nerve ProtectorTM and the upcoming launch of Avive+ Soft Tissue MatrixTM and we are pleased to announce the internal promotions of these leaders in our research and development team,” said Karen Zaderej, Axogen’s Chairman, CEO and President. “This is a strong, highly accomplished group that has worked together closely for many years and demonstrated great success in supporting our mission of improving the lives of patients with peripheral nerve injuries. The continuity of this expert team will also be important to Axogen as we move through the BLA submission process of Avance® Nerve Graft toward the next commercial phase of our business as a biologic.

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 that are used across two primary application categories: scheduled, non-trauma procedures and emergent trauma procedures. Scheduled procedures are generally characterized as those where a patient is seeking relief from conditions caused by a nerve defect or surgical procedure. These procedures include providing sensation for women seeking breast reconstruction following a mastectomy, nerve reconstruction following the surgical removal of painful neuromas, oral and maxillofacial procedures, and nerve decompression. Emergent procedures are generally characterized as procedures resulting from injuries that initially present in an ER. These procedures are typically referred to and completed by a specialist either immediately or within a few days following the initial injury.

Axogen’s product portfolio includes 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 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 HA+ Nerve Protector™, a porcine submucosa ECM base layer coated with a proprietary hyaluronate-alginate gel, a next-generation technology designed to enhance nerve gliding and provide short- and long-term protection for peripheral nerve injuries; and 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. The Axogen portfolio of products is available in the United States, Canada, Germany, the 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. Forward-looking statements include the statement about the upcoming launch of Avive+ Soft Tissue Matrix, the departure of Angelo Scopelianos in the first quarter of 2024, and the continuity of the expert team as we move through the BLA submission process of Avance® Nerve Graft toward the next commercial phase of our business as a biologic. Actual results or events could differ materially from those described in any forward-looking statements as a result of various factors, including, without limitation, potential disruptions caused by leadership transitions, global supply chain issues, record inflation, hospital staffing issues, product development, product potential, expected clinical enrollment timing and outcomes, regulatory process and approvals, processing facility transition timing and expense, financial performance, sales growth, surgeon and product adoption, market awareness of our products, data validation, our visibility at and sponsorship of conferences and educational events, global business disruption caused by Russia’s invasion of Ukraine and related sanctions, recent geopolitical conflicts in the Middle East, as well as those risk factors described under Part I, Item 1A., “Risk Factors,” of our Annual Report on Form 10-K for the most recently ended fiscal year and Part II, Item 1A., “Risk Factors,” for our Quarterly Report on Form 10-Q for the most recently ended fiscal quarter. 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.

For more information, visit www.axogeninc.com.

Contact:

Axogen, Inc.

Harold D. Tamayo, VP of Finance and Investor Relations

htamayo@axogeninc.com


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Source: Axogen, Inc. ]]>
Axogen, Inc. Appoints Kathy Weiler to its Board of Directors https://ir.axogeninc.com/news/detail/970/axogen-inc-appoints-kathy-weiler-to-its-board-of-directors Tue, 26 Dec 2023 16:15:00 -0500 https://ir.axogeninc.com/news/detail/970/axogen-inc-appoints-kathy-weiler-to-its-board-of-directors Weiler brings 20+ years of strategic and commercial leadership experience to the Axogen, Inc. Board of Directors

ALACHUA, Fla. and TAMPA, Fla., Dec. 26, 2023 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, is pleased to announce today the appointment of Mrs. Kathy Weiler to its Board of Directors, effective December 20, 2023. Weiler, a senior executive with 20+ years of experience and proven track record in driving strategic commercial initiatives, will serve on the Board’s Governance, Nominating and Sustainability Committee, and the Quality, Compliance, and Portfolio Management Committee.

“I am happy to welcome Kathy to the Board as Axogen is approaching an exciting inflection point in its journey,” commented Karen Zaderej, chairman, CEO, and president. “We look forward to working closely with Kathy and leveraging her extensive commercial experience to support Axogen’s patient activation and commercial execution, as we drive toward being cash flow positive.”

Weiler is the Executive Vice President, Chief Commercial and Growth Officer at Amwell (NYSE: AMWL). Weiler oversees the company’s growth strategy, driving strategic initiatives and leading business development, sales and account management, commercial enablement, marketing, and strategic and channel partnership teams. Prior to Amwell, Weiler served as Chief Consumer Officer at Optum, where she led consumerism across the enterprise. Preceding that, she was Chief Consumer Strategy Officer at UnitedHealth Group and the Chief Marketing and Experience Officer of Optum Health, leading marketing efforts for Optum Care and Optum’s Population Health Solutions, Complex Care Management, Medical Benefits Management, Behavioral Health, Prevention and Financial Services businesses. Weiler also served as Chief Marketing and Product Officer at Blue Cross and Blue Shield of Massachusetts, where she drove strategic growth and retention business objectives. Weiler spent her earlier career with multiple financial services organizations. She was Chief Marketing Officer of Fidelity Investments FAS business and held senior marketing leadership roles at BNY Mellon/Pershing and The Hartford. Weiler holds a B.A. from Bowdoin College and an M.A. in International Economics and Finance from Brandeis University.

“I am impressed by Axogen’s unique products that restore quality of life for patients with nerve injuries,” said Weiler. “I am excited to join the Board and contribute to the Company’s strategic path, and it’s commercial success.”

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 that are used across two primary application categories: scheduled, non-trauma procedures and emergent trauma procedures. Scheduled procedures are generally characterized as those where a patient is seeking relief from conditions caused by a nerve defect or surgical procedure. These procedures include providing sensation for women seeking breast reconstruction following a mastectomy, nerve reconstruction following the surgical removal of painful neuromas, oral and maxillofacial procedures, and nerve decompression. Emergent procedures are generally characterized as procedures resulting from injuries that initially present in an ER. These procedures are typically referred to and completed by a specialist either immediately or within a few days following the initial injury.

Axogen’s product portfolio includes 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 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 HA+ Nerve Protector™, a porcine submucosa ECM base layer coated with a proprietary hyaluronate-alginate gel, a next-generation technology designed to provide short- and long-term protection for peripheral nerve injuries; and 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. The Axogen portfolio of products is available in the United States, Canada, Germany, the 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. Forward looking statements include the statement that Axogen is approaching an exciting inflection point in its journey and the statement about leveraging Mrs. Weiler’s extensive commercial experience to support Axogen’s patient activation and commercial execution as we drive toward being cash flow positive. Actual results or events could differ materially from those described in any forward-looking statements as a result of various factors, including, without limitation, the continued impact of COVID-19, global supply chain issues, record inflation, hospital staffing issues, product development, product potential, expected clinical enrollment timing and outcomes, regulatory process and approvals, processing facility transition timing and expense, financial performance, sales growth, surgeon and product adoption, market awareness of our products, data validation, our visibility at and sponsorship of conferences and educational events, global business disruption caused by Russia’s invasion of Ukraine and related sanctions, as well as those risk factors described under Part I, Item 1A., “Risk Factors,” of our Annual Report on Form 10-K for the most recently ended fiscal year and Part II, Item 1A., “Risk Factors,” for our Quarterly Report on Form 10-Q for the most recently ended fiscal quarter. 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.

Contact:
Axogen, Inc.
Harold D. Tamayo, Vice President, Finance and Investor Relations
htamayo@axogeninc.com


Primary Logo

Source: Axogen, Inc. ]]>
Axogen Announces Transition of Finance Team Leadership https://ir.axogeninc.com/news/detail/969/axogen-announces-transition-of-finance-team-leadership Wed, 06 Dec 2023 07:00:00 -0500 https://ir.axogeninc.com/news/detail/969/axogen-announces-transition-of-finance-team-leadership Nir Naor Appointed CFO to Replace Peter Mariani as Company Aligns Executive Team with Financial Management Needs for Next Phase of Growth

ALACHUA, Fla. and TAMPA, Fla., Dec. 06, 2023 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced the appointment of Mr. Nir Naor as Chief Financial Officer, effective immediately. A senior finance executive with more than 20 years of experience primarily in the life sciences industry, he replaces Peter Mariani, who will depart Axogen following a brief transition period. The move aligns the executive team with the Company’s financial management and investor relations needs going forward as Axogen focuses on continued revenue growth across both business categories while driving toward being cash flow positive and profitable.

“We determined with the Board of Directors that a change to our finance team leadership was in Axogen’s best interests as our strategic focus evolves,” said Karen Zaderej, the Company’s Chairman, President and Chief Executive Officer. “Pete was integral in helping us build Axogen and our platform for product manufacturing and sales growth. We are grateful to him for his contributions as a dedicated member of our team. Looking ahead, we are confident that Nir brings strategic commercial and operational expertise to Axogen that is important to our next phase of growth and commercial execution.”

“I am impressed by Axogen’s unique offering, market leadership, and potential. I am excited to join the Company and leverage my experience to support it in its growth and trajectory towards profitability,” said Mr. Naor.

Mr. Naor has diverse finance and operations leadership experience with public and private pharma, life sciences, and medtech companies worldwide. In previous roles, he managed global organizations with up to $2.5 billion in sales and built top-performing finance & accounting, IR, legal, contracting & pricing, IT, and big data analytics functions. Mr. Naor has served as the CFO of Arbor Pharmaceuticals and supported its strategic pivot. He was also the CFO U.S. / Americas of Mölnlycke Healthcare, where he played a pivotal role in its growth and profitability improvement and was the founder of UCB’s global Portfolio Management and Resource Allocation function, as well as the company’s U.S. CFO. Earlier in his career, he held several finance leadership positions with AstraZeneca, served as a financial consultant and investment banker, worked as an auditor with KPMG, and practiced commercial law. He continues to advise and serve as a board member for emerging life sciences and technology companies.

Mr. Naor holds a Master of Business Administration from IMD Business School in Switzerland, a master’s degree in law (LL.M.) from Hamburg University in Germany, and bachelor’s degrees in law (LL.B.) and in accounting from the Tel-Aviv University in Israel. Mr. Naor is also a CFA® charterholder.

In conjunction with the hiring of Mr. Naor, Axogen announced inducement grants under NASDAQ Listing Rule 5635(c)(4). Specifically, in connection with the commencement of his employment on Dec. 4, 2023, and as a material inducement of employment, he will be awarded an equity grant on Jan. 1, 2024, consisting of non-qualified restricted stock units (“RSUs”) representing 300,000 shares of the Company’s common stock. Shares representing 1/3 of the RSUs will vest on the one-year anniversary of the grant date, and shares representing 1/6 of the RSUs will vest on each six-month anniversary thereafter.

The Company is maintaining full-year 2023 revenue guidance in the range of $154 million to $159 million, which represents annual growth of 11% - 15%. The Company anticipates that gross margin will be reduced with the continued transition to the new processing facility in the fourth quarter and continues to expect that gross margin for the full year 2023 will be approximately 80%.

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 that are used across two primary application categories: scheduled, non-trauma procedures and emergent trauma procedures. Scheduled procedures are generally characterized as those where a patient is seeking relief from conditions caused by a nerve defect or surgical procedure. These procedures include providing sensation for women seeking breast reconstruction following a mastectomy, nerve reconstruction following the surgical removal of painful neuromas, oral and maxillofacial procedures, and nerve decompression. Emergent procedures are generally characterized as procedures resulting from injuries that initially present in an ER. These procedures are typically referred to and completed by a specialist either immediately or within a few days following the initial injury.

Axogen’s product portfolio includes 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 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 HA+ Nerve Protector™, a porcine submucosa ECM base layer coated with a proprietary hyaluronate-alginate gel, a next-generation technology designed to provide short- and long-term protection for peripheral nerve injuries; and 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. The Axogen portfolio of products is available in the United States, Canada, Germany, the 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. Forward-looking statements include the statement maintaining full-year 2023 revenue guidance in the range of $154 million to $159 million, and the statement that the Company anticipates that gross margin will be reduced with the continued transition to the new processing facility in the fourth quarter and continues to expect that gross margin for the full year 2023 will be approximately 80%. Actual results or events could differ materially from those described in any forward-looking statements as a result of various factors, including, without limitation, the continued impact of COVID-19, global supply chain issues, record inflation, hospital staffing issues, product development, product potential, expected clinical enrollment timing and outcomes, regulatory process and approvals, processing facility transition timing and expense, financial performance, sales growth, surgeon and product adoption, market awareness of our products, data validation, our visibility at and sponsorship of conferences and educational events, global business disruption caused by Russia’s invasion of Ukraine and related sanctions, as well as those risk factors described under Part I, Item 1A., “Risk Factors,” of our Annual Report on Form 10-K for the most recently ended fiscal year and Part II, Item 1A., “Risk Factors,” for our Quarterly Report on Form 10-Q for the most recently ended fiscal quarter. 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.

Contact Information

Investor Relations
Axogen, Inc.
Harold D. Tamayo
htamayo@axogeninc.com
401-479-3408

Media Relations
Russo Partners
David Schull
david.schull@russopartnersllc.com
858-717-2310


Primary Logo

Source: Axogen, Inc. ]]>
Company Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) https://ir.axogeninc.com/news/detail/968/company-reports-inducement-grants-under-nasdaq-listing-rule-5635c4 Fri, 01 Dec 2023 17:00:00 -0500 https://ir.axogeninc.com/news/detail/968/company-reports-inducement-grants-under-nasdaq-listing-rule-5635c4 ALACHUA and TAMPA, Fla., Dec. 01, 2023 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced making Inducement Grants Under NASDAQ Listing Rule 5635(c)(4) in connection with the employment and appointment of Harold D. Tamayo as Vice President of Finance and Investor Relations. Mr. Tamayo will report to Peter J. Mariani, Executive Vice President and Chief Financial Officer, and will be responsible for Financial Planning and Analysis and Investor Relations.

Mr. Tamayo has over 20 years of experience in healthcare and life sciences including as a division CFO and in leadership roles in Investor Relations and Corporate FP&A in companies such as McKesson, Merck, Novartis, and CVS Health. Most recently he served as Interim CFO of Neighborhood LTC Pharmacy, a technology healthcare management and pharmacy company in Lincoln, NE. Prior to this he served as SVP Corporate Finance, M&A, Investor Relations for McKesson, a diversified healthcare company. Mr. Tamayo earned his Bachelor of Science in Electrical Engineering from Florida International University, followed by dual master’s degrees in business administration and industrial engineering from the University of Miami.

In connection with the commencement of his employment on November 27, 2023, and as a material inducement of employment, Mr. Tamayo was awarded an equity grant on December 1, 2023, consisting of (i) non-qualified stock options to purchase 65,800 shares of the Company’s common stock and (ii) non-qualified restricted stock units (“RSUs”) representing 37,500 shares of the Company’s common stock. The stock options have an exercise price of $6.88 per share, a 10-year term, and will vest over a four-year period, with 50% vesting after the second year and 12.5% of the total shares granted vesting every six months thereafter for the next two years. The RSUs are subject to vesting over 4 years, with 50% vesting after the second year and 25% of the total shares granted vesting every year thereafter for the next two years.

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 that are used across two primary application categories: scheduled, non-trauma procedures and emergent trauma procedures. Scheduled procedures are generally characterized as those where a patient is seeking relief from conditions caused by a nerve defect or surgical procedure. These procedures include providing sensation for women seeking breast reconstruction following a mastectomy, nerve reconstruction following the surgical removal of painful neuromas, oral and maxillofacial procedures, and nerve decompression. Emergent procedures are generally characterized as procedures resulting from injuries that initially present in an ER. These procedures are typically referred to and completed by a specialist either immediately or within a few days following the initial injury.

Axogen’s product portfolio includes 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 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 HA+ Nerve Protector™, a porcine submucosa ECM base layer coated with a proprietary hyaluronate-alginate gel, a next-generation technology designed to provide short- and long-term protection for peripheral nerve injuries; and 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. The Axogen portfolio of products is available in the United States, Canada, Germany, the United Kingdom, Spain, South Korea, and several other countries.

Contact:
Axogen, Inc.
Harold D. Tamayo, VP of Finance and Investor Relations
htamayo@axogeninc.com


Primary Logo

Source: Axogen, Inc. ]]>
Axogen, Inc. to Participate at the Piper Sandler 35th Annual Healthcare Conference https://ir.axogeninc.com/news/detail/967/axogen-inc-to-participate-at-the-piper-sandler-35th-annual-healthcare-conference Mon, 20 Nov 2023 07:00:00 -0500 https://ir.axogeninc.com/news/detail/967/axogen-inc-to-participate-at-the-piper-sandler-35th-annual-healthcare-conference ALACHUA and TAMPA, Fla., Nov. 20, 2023 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced that Karen Zaderej, Chairman, Chief Executive Officer, and President, will present at the Piper Sandler 35th Annual Healthcare Conference in New York, NY, on Thursday, November 30, 2023, at 8:50 a.m. E.T.

Webcast events can be accessed live through the Investors page at www.axogeninc.com. For those not available to listen to the live broadcast, the 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 that are used across two primary application categories: scheduled, non-trauma procedures and emergent trauma procedures. Scheduled procedures are generally characterized as those where a patient is seeking relief from conditions caused by a nerve defect or surgical procedure. These procedures include providing sensation for women seeking breast reconstruction following a mastectomy, nerve reconstruction following the surgical removal of painful neuromas, oral and maxillofacial procedures, and nerve decompression. Emergent procedures are generally characterized as procedures resulting from injuries that initially present in an ER. These procedures are typically referred to and completed by a specialist either immediately or within a few days following the initial injury.

Axogen’s product portfolio includes 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 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 HA+ Nerve Protector™, a porcine submucosa ECM base layer coated with a proprietary hyaluronate-alginate gel, a next-generation technology designed to provide short- and long-term protection for peripheral nerve injuries; and 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. The Axogen portfolio of products is available in the United States, Canada, Germany, the United Kingdom, Spain, South Korea, and several other countries.

Contact:
Axogen, Inc.
InvestorRelations@axogeninc.com


Primary Logo

Source: Axogen, Inc. ]]>
Axogen, Inc. Reports 2023 Third Quarter Financial Results https://ir.axogeninc.com/news/detail/966/axogen-inc-reports-2023-third-quarter-financial-results Tue, 07 Nov 2023 07:00:00 -0500 https://ir.axogeninc.com/news/detail/966/axogen-inc-reports-2023-third-quarter-financial-results ALACHUA, Fla. and TAMPA, Fla., Nov. 07, 2023 (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 third quarter ended September 30, 2023.

Third Quarter Financial Results

  • Revenue was $41.3 million during the third quarter, an increase of approximately 12% over the third quarter of 2022.
  • The Company estimates that revenues from emergent trauma procedures represented approximately half of total revenues during the third quarter and grew in the mid-single digit range versus the third quarter of 2022.
  • The Company estimates that revenues from scheduled non-trauma procedures represented approximately half of total revenues during the third quarter and grew approximately 20% from the third quarter of 2022.
  • Gross margin was 80.5% for the quarter, compared to 83.3% in the third quarter of 2022.
  • Net loss of $4.1 million, or $0.10 per share, compared to net loss of $4.3 million, or $0.10 per share in the third quarter of 2022.
  • Adjusted net income of $0.7 million or $0.01 per share, compared to adjusted net loss of $0.4 million, or $0.01 per share, in the third quarter of 2022.
  • Adjusted EBITDA of $2.4 million, compared to adjusted EBITDA of $0.4 million in the third quarter of 2022.
  • The balance of all cash and cash equivalents and investments on September 30, 2023, was $38.6 million, compared to $40.8 million on June 30, 2023. The net change of $2.2 million includes interest and other charges capitalized into the Company's new processing facility.

“We are pleased with our performance in the quarter, which includes improvement in our emergent trauma category as well as continued strength in scheduled procedures. This performance was driven by stabilization in the hospital operating environment, and improved commercial execution,” stated Karen Zaderej, Axogen's Chairman, CEO, and President. “We remain focused on executing our strategic initiatives anchored in the strength of our clinical data, innovation, market development, and commercial execution to continue to drive surgeon adoption and growth.”

Operational and Business Highlights

  • In August, the Company began processing tissue in the new, state-of-the-art APC facility, which provides for up to 3 times current capacity and was designed for long-term growth and expansion.
  • The Company is continuing to expand its offering in the nerve protection market with the national launch of Axoguard HA+ Nerve Protector™ in August, and expects to launch Avive+ Soft Tissue Matrix™ in Q1 2024.
  • The Company continues to anticipate a Pre-BLA meeting with the FDA in early first quarter 2024 where it will request utilization of a rolling submission process for the Biologics License Application (BLA) for Avance® nerve graft which would begin later in the first quarter. The Company anticipates completing the submission in the second quarter of 2024 and believes this process will support BLA approval in the first half of 2025.
  • The Company has exceeded its initial goal of training 20 additional surgical teams on techniques in implant-based Resensation® and now expects to have more than 30 teams trained by the end of this year.
  • Core Accounts totaled 372, an increase of 12% over prior-year level of 331, and an increase of 7% sequentially. Revenue from Core Accounts now represent approximately 65% of revenue, up from approximately 60% in prior quarters.
  • Active Accounts totaled 1016, an increase of 7% over prior-year level of 952, and an increase of 4% sequentially.
  • Ended the quarter with over 200 peer-reviewed clinical publications featuring Axogen’s nerve repair product portfolio.
  • Ended the quarter with 116 direct sales representatives compared to 115 on June 30, 2023, and 111 a year ago.

2023 Financial Guidance

Management is maintaining full-year 2023 revenue guidance in the range of $154 million to $159 million, which represents annual growth of 11% - 15%. The Company anticipates that gross margin will be reduced with the continued transition to the new processing facility in the fourth quarter and continues to expect that gross margin for the full year 2023 will be approximately 80%.

Axoguard HA+ Nerve Protector Launch

In August 2023, the Company completed the full market release of Axoguard HA+ Nerve Protector™, an extension of its nerve protection platform. Axoguard HA+ Nerve Protector is a proprietary nerve protection device designed to provide short- and long-term protection for peripheral nerve injuries. The device is comprised of a processed porcine submucosa extracellular matrix (ECM) base layer with a hyaluronate-alginate gel coating. The gel layer facilitates enhanced nerve gliding to aid in minimizing soft tissue attachments, while the base layer is remodeled into a long-term protective tissue layer. It is available in a variety of sizes to meet patients' and surgeons’ needs.

Conference Call

The Company will host a conference call and webcast for the investment community today at 8:00 a.m. ET. Investors interested in participating in the conference call by phone may do so by dialing toll free at (877) 407-0993 or using 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 under Investors.

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.

A 2010 written agreement between the FDA and Axogen allows the company to continue marketing Avance as a section 361 Human Cells, Tissues and Cellular and Tissue Based Product (HCT/P) while taking the necessary steps to file a Biologics License Application (BLA) under section 351.

In 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 that are used across two primary application categories: scheduled, non-trauma procedures and emergent trauma procedures. Scheduled procedures are generally characterized as those where a patient is seeking relief from conditions caused by a nerve defect or surgical procedure. These procedures include providing sensation for women seeking breast reconstruction following a mastectomy, nerve reconstruction following the surgical removal of painful neuromas, oral and maxillofacial procedures, and nerve decompression. Emergent procedures are generally characterized as procedures resulting from injuries that initially present in an ER. These procedures are typically referred to and completed by a specialist either immediately or within a few days following the initial injury.

Axogen’s product portfolio includes 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 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 HA+ Nerve Protector™, a porcine submucosa ECM base layer coated with a proprietary hyaluronate-alginate gel, a next-generation technology designed to provide short- and long-term protection for peripheral nerve injuries; and 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. The Axogen portfolio of products is available in the United States, Canada, Germany, the 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. Forward-looking statements include statement on benefits and market opportunities, our ability to submit the BLA on a rolling basis, timing of the submission and approval of the BLA, development and market launch timetable for Avive+, as well as statements under the subheading "2023 Financial Guidance." Actual results or events could differ materially from those described in any forward-looking statements as a result of various factors, including, without limitation, statements related to the continued impact of COVID-19, global supply chain issues, record inflation, hospital staffing issues, product development, product potential, expected clinical enrollment timing and outcomes, regulatory process and approvals, APC transition timing and expense, financial performance, sales growth, surgeon and product adoption, market awareness of our products, data validation, our visibility at and sponsorship of conferences and educational events, global business disruption caused by Russia’s invasion of Ukraine and related sanctions, as well as those risk factors described under Part I, Item 1A., “Risk Factors,” of our Annual Report on Form 10-K for the most recently ended fiscal year and Part II, Item 1A., “Risk Factors,” for our Quarterly Report on Form 10-Q for the most recently ended fiscal quarter. 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.

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, and 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 Loss and Adjusted Net 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 the non-GAAP measures to the most directly comparable financial measures calculated and presented in accordance with GAAP 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, the Company’s cash available for operations, and the Company’s ability to meet future capital expenditure and working capital requirements.

Contact:
Axogen, Inc.
InvestorRelations@axogeninc.com

Axogen, Inc.
Condensed Consolidated Balance Sheets
(unaudited)
(In thousands, except share and per share amounts)
 
September 30,
2023
  December 31,
2022
 
Assets            
Current assets:            
Cash and cash equivalents $ 31,094     $ 15,284    
Restricted cash   6,002       6,251    
Investments   1,494       33,505    
Accounts receivable, net of allowance for doubtful accounts of $319 and $650, respectively   23,263       22,186    
Inventory   23,019       18,905    
Prepaid expenses and other   2,567       1,944    
 Total current assets   87,439       98,075    
Property and equipment, net   89,030       79,294    
Operating lease right-of-use assets   13,873       14,369    
Intangible assets, net   4,288       3,649    
 Total assets $ 194,630     $ 195,387    
               
Liabilities and shareholders’ equity                
Current liabilities:                
Accounts payable and accrued expenses $ 25,550     $ 22,443    
Current maturities of long-term lease obligations   1,096       1,310    
 Total current liabilities   26,646       23,753    
               
Long-term debt, net of debt discount and financing fees   46,378       45,712    
Long-term lease obligations   19,927       20,405    
Debt derivative liabilities   3,869       4,518    
 Total liabilities   96,820       94,388    
               
Commitments and contingencies - see Note 12                
               
Shareholders’ equity:                
Common stock, $0.01 par value per share; 100,000,000 shares authorized; 43,039,399 and
42,445,517 shares issued and outstanding
  430       424    
Additional paid-in capital   374,783       360,155    
Accumulated deficit   (277,403 )     (259,580 )  
 Total shareholders’ equity   97,810       100,999    
 Total liabilities and shareholders’ equity $ 194,630     $ 195,387    
 


Axogen, Inc.
Condensed Consolidated Statements of Operations
(unaudited)
(In thousands, except share and per share amounts)​
 
Three Months Ended   Nine Months Ended
 
September 30,
2023
  September 30,
2022
  September 30,
2023
  September 30,
2022
 
                       
Revenues $ 41,271     $ 36,959     $ 116,090     $ 102,420    
Cost of goods sold   8,043       6,176       21,980       18,006    
 Gross profit   33,228       30,783       94,110       84,414    
Costs and expenses:                                
Sales and marketing   21,429       19,792       63,885       60,349    
Research and development   6,989       7,050       21,032       20,347    
General and administrative   8,835       8,796       27,461       27,817    
 Total costs and expenses   37,253       35,638       112,378       108,513    
 Loss from operations   (4,025 )     (4,855 )   $ (18,268 )     (24,099 )  
Other income (expense):                                
Investment income (loss)   367       186       1,151       172    
Interest expense   (827 )     (61 )     (992 )     (664 )  
Change in fair value of derivatives   402       469       649       1,155    
Other expense   (6 )     (57 )     (363 )     (97 )  
 Total other (expense) income, net   (64 )     537       445       566    
Net loss $ (4,089 )   $ (4,318 )   $ (17,823 )   $ (23,533 )  
                                 
Weighted average common shares outstanding — basic
and diluted
  43,022,328       42,220,519       42,821,284       42,008,013    
Loss per common share — basic and diluted $ (0.10 )   $ (0.10 )   $ (0.42 )   $ (0.56 )  
 


Axogen, Inc.
RECONCILIATION OF GAAP FINANCIAL MEASURES TO NON-GAAP FINANCIAL MEASURES
(unaudited)
(In thousands, except share and per share amounts)​
 
  Three Months Ended   Nine Months Ended
 
  September 30,
2023
  September 30,
2022
  September 30,
2023
  September 30,
2022

 
                                 
Net loss $ (4,089 )   $ (4,318 )   $ (17,823 )   $ (23,533 )  
Depreciation and amortization expense   1,224       830       2,874       2,380    
Investment income   (367 )     (186 )     (1,151 )     (172 )  
Income tax expense   12       31       331       64    
Interest expense   827       61       992       664    
EBITDA - non GAAP $ (2,393 )   $ (3,582 )   $ (14,777 )   $ (20,597 )  
                                 
Non cash stock-based compensation expense $ 4,747     $ 3,849     $ 13,091     $ 11,437    
Litigation and related costs         101             584    
Adjusted EBITDA (loss) - non GAAP $ 2,354     $ 368     $ (1,686 )   $ (8,576 )  
                                 
Net loss $ (4,089 )   $ (4,318 )   $ (17,823 )   $ (23,533 )  
Non cash stock-based compensation expense   4,747       3,849       13,091       11,437    
Litigation and related costs         101             584    
Adjusted net income (loss) - non GAAP $ 658     $ (368 )   $ (4,732 )   $ (11,512 )  
                                 
Weighted average common shares outstanding —
basic and diluted
  43,022,328       42,220,519       42,821,284       42,008,013    
                                 
Loss per common share — basic and diluted $ (0.10 )   $ (0.10 )   $ (0.42 )   $ (0.56 )  
Non cash stock-based compensation expense $ 0.11     $ 0.09     $ 0.31     $ 0.27    
Litigation and related costs $     $     $     $ 0.01    
Adjusted net income (loss) per common share —
basic and diluted - non GAAP
$ 0.01     $ (0.01 )   $ (0.11 )   $ (0.28 )  
 

​Axogen, Inc.
Condensed Consolidated Statements of Changes in Shareholders’ Equity
(unaudited)
(In thousands, except share amounts)
 
Common Stock
  Additional
Paid-in

Capital
  Accumulated
Deficit
  Total
Shareholders'

Equity
 
Shares   Amount
       
Three Months Ended September 30, 2023                              
Balance at June 30, 2023   42,979,541     $ 430     $ 370,036     $ (273,314 )     97,152    
Net loss                     (4,089 )     (4,089 )  
Stock-based compensation               4,747             4,747    
Issuance of restricted and performance stock
units
  59,858                            
Exercise of stock options and employee stock
purchase plan
                             
Balance at September 30, 2023   43,039,399     $ 430     $ 374,783     $ (277,403 )     97,810    
                                       
Nine Months Ended September 30, 2023                                        
Balance at December 31, 2022   42,445,517     $ 424     $ 360,155     $ (259,580 )   $ 100,999    
Net loss                     (17,823 )     (17,823 )  
Stock-based compensation               13,091             13,091    
Issuance of restricted and performance stock
units
  356,236       4       (4 )              
Exercise of stock options and employee stock
purchase plan
  237,646       2       1,541             1,543    
Balance at September 30, 2023   43,039,399     $ 430       374,783     $ (277,403 )   $ 97,810    
                                         
Three Months Ended September 30, 2022                                        
Balance at June 30, 2022   42,134,504     $ 420     $ 351,117     $ (249,847 )     101,690    
Net loss                     (4,318 )     (4,318 )  
Stock-based compensation               3,849             3,849    
Issuance of restricted and performance stock
units
  55,934       1       (1 )              
Exercise of stock options and employee stock
purchase plan
  81,785       2       222             224    
Balance at September 30, 2022   42,272,223     $ 423     $ 355,187     $ (254,165 )   $ 101,445    
                                         
Nine Months Ended September 30, 2022                                        
Balance at December 31, 2021   41,736,950     $ 417     $ 342,765     $ (230,632 )   $ 112,550    
Net loss                     (23,533 )     (23,533 )  
Stock-based compensation               11,437             11,437    
Issuance of restricted and performance stock
units
  315,275       3       (3 )              
Exercise of stock options and employee stock
purchase plan
  219,998       3       988             991    
Balance at September 30, 2022   42,272,223     $ 423     $ 355,187     $ (254,165 )   $ 101,445    
 

​​

Axogen, Inc.
Condensed Consolidated Statements of Cash Flows
(unaudited)
(In thousands)
 
Nine Months Ended
 
September 30, 2023   September 30, 2022
 
Cash flows from operating activities:                
Net loss $ (17,823 )   $ (23,533 )  
Adjustments to reconcile net loss to net cash used in operating activities:                
    Depreciation   2,660       2,182    
    Amortization of right-of-use assets   826       1,303    
    Amortization of intangible assets   214       198    
    Amortization of debt discount and deferred financing fees   666       667    
    Provision for bad debt   (311 )     566    
    Provision for inventory write-down   1,841       1,381    
    Change in fair value of derivatives   (649 )     (1,155 )  
    Change in investment gains or losses   (660 )     44    
    Stock-based compensation   13,091       11,437    
    Change in operating assets and liabilities:                
    Accounts receivable   (766 )     (3,695 )  
    Inventory   (5,955 )     (3,804 )  
    Prepaid expenses and other   (623 )     (828 )  
    Accounts payable and accrued expenses   3,012       (870 )  
    Operating lease obligations   (1,012 )     (1,320 )  
    Cash paid for interest portion of finance leases   (2 )     (1 )  
    Contract and other liabilities   (14 )        
Net cash used in operating activities   (5,505 )     (17,428 )  
Cash flows from investing activities:                
Purchase of property and equipment   (12,409 )     (13,456 )  
Purchase of investments   (10,203 )     (24,607 )  
Proceeds from sale of investments   42,874       37,100    
Cash payments for intangible assets   (732 )     (1,028 )  
Net cash from (used in) investing activities   19,530       (1,991 )  
Cash flows from financing activities:                
Cash paid for debt portion of finance leases   (7 )     (9 )  
Proceeds from exercise of stock options and ESPP stock purchases   1,543       990    
Net cash provided by financing activities   1,536       981    
Net increase (decrease) in cash, cash equivalents, and restricted cash   15,561       (18,438 )  
Cash, cash equivalents, and restricted cash, beginning of period   21,535       39,007    
Cash, cash equivalents, and restricted cash, end of period $ 37,096     $ 20,569    
Supplemental disclosures of cash flow activity:                
Cash paid for interest, net of capitalized interest $ 325     $    
Supplemental disclosure of non-cash investing and financing activities:                
Acquisition of fixed assets in accounts payable and accrued expenses $ 853     $ 2,090    
Obtaining of property and equipment in exchange for a lease liability $     $ 22    
Obtaining a right-of-use asset in exchange for a lease liability $ 366     $ 920    
Acquisition of intangible assets in accounts payable and accrued expenses $ 420     $ 177    
 

Primary Logo

Source: Axogen, Inc. ]]>
Axogen, Inc. to Report Third Quarter 2023 Financial Results and Host Conference Call on November 7, 2023 https://ir.axogeninc.com/news/detail/965/axogen-inc-to-report-third-quarter-2023-financial-results-and-host-conference-call-on-november-7-2023 Wed, 18 Oct 2023 07:00:00 -0400 https://ir.axogeninc.com/news/detail/965/axogen-inc-to-report-third-quarter-2023-financial-results-and-host-conference-call-on-november-7-2023 ALACHUA, Fla. and TAMPA, Fla., Oct. 18, 2023 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced that it will report third quarter 2023 financial results on Tuesday, November 7, 2023 before the market opens. Axogen management will host an investment-community conference call and webcast at 8:00 a.m. ET following the release.

Investors interested in participating in the conference call by phone may do so by dialing toll free at (877) 407-0993 or using 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 that are used across two primary application categories: scheduled, non-trauma procedures and emergent trauma procedures. Scheduled procedures are generally characterized as those where a patient is seeking relief from conditions caused by a nerve defect or surgical procedure. These procedures include providing sensation for women seeking breast reconstruction following a mastectomy, nerve reconstruction following the surgical removal of painful neuromas, oral and maxillofacial procedures, and nerve decompression. Emergent procedures are generally characterized as procedures resulting from injuries that initially present in an ER. These procedures are typically referred to and completed by a specialist either immediately or within a few days following the initial injury.

Axogen’s product portfolio includes 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 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 HA+ Nerve Protector™, a porcine submucosa ECM base layer coated with a proprietary hyaluronate-alginate gel, a next-generation technology designed to provide short- and long-term protection for peripheral nerve injuries; and 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. The Axogen portfolio of products is available in the United States, Canada, Germany, the United Kingdom, Spain, South Korea, and several other countries.

Contact:
Axogen, Inc.
InvestorRelations@axogeninc.com


Primary Logo

Source: Axogen, Inc. ]]>
Axogen, Inc. Announces Full Launch of Axoguard HA+ Nerve Protector™ https://ir.axogeninc.com/news/detail/964/axogen-inc-announces-full-launch-of-axoguard-ha-nerve-protector Tue, 05 Sep 2023 07:00:00 -0400 https://ir.axogeninc.com/news/detail/964/axogen-inc-announces-full-launch-of-axoguard-ha-nerve-protector ALACHUA, Fla. and TAMPA, Fla., Sept. 05, 2023 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced the full launch of Axoguard HA+ Nerve Protector.

“Axoguard HA+ is an important extension of our nerve protection platform,” commented Karen Zaderej, Axogen's Chairman, CEO, and President. “The release of Axoguard HA+ expands opportunities for surgeons to treat a wider range of nerve protection challenges.”

Axoguard HA+ Nerve Protector is a proprietary nerve protection device uniquely designed to provide both short- and long-term protection for peripheral nerve injuries. The device is comprised of a processed porcine submucosa extracellular matrix base layer with a hyaluronate-alginate gel coating. The gel layer facilitates enhanced nerve gliding to aid in minimizing soft tissue attachments, while the base layer is remodeled into a long-term protective tissue layer.

The nerve protection category covers a wide range of injuries and defects, including nerve compression, crush, and complex traumatic injuries. The diversity of these injury types and their anatomical locations present unique challenges for both the surgeon and the patient. Optimizing outcomes requires targeted solutions to adequately address the nerve and the surrounding environment throughout the healing process.

“Axoguard HA+ has the potential to greatly impact patients who suffer from compression nerve injuries, particularly where the injury is in proximity to high mobility joints,” noted Dr. Peter J. Evans, MD, PhD, Division Chair, Orthopedics Surgery, Cleveland Clinic Florida Region. “The increased gliding feature and optimized handling of Axoguard HA+ Nerve Protector allows surgeons to address the challenges of these injury types during the early and most critical phases of healing.”

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 that are used across two primary application categories: scheduled, non-trauma procedures and emergent trauma procedures. Scheduled procedures are generally characterized as those where a patient is seeking relief from conditions caused by a nerve defect or surgical procedure. These procedures include providing sensation for women seeking breast reconstruction following a mastectomy, nerve reconstruction following the surgical removal of painful neuromas, oral and maxillofacial procedures, and nerve decompression. Emergent procedures are generally characterized as procedures resulting from injuries that initially present in an ER. These procedures are typically referred to and completed by a specialist either immediately or within a few days following the initial injury.

Axogen’s product portfolio includes 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 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 HA+ Nerve Protector™, a porcine submucosa ECM base layer coated with a proprietary hyaluronate-alginate gel, a next-generation technology designed to provide short- and long-term protection for peripheral nerve injuries; and 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. The Axogen portfolio of products is available in the United States, Canada, Germany, the 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. Actual results or events could differ materially from those described in any forward-looking statements as a result of various factors, including, without limitation, statements related to the continued impact of COVID-19, global supply chain issues, record inflation, hospital staffing issues, product development, product potential, expected clinical enrollment timing and outcomes, regulatory process and approvals, APC renovation timing and expense, financial performance, sales growth, surgeon and product adoption, market awareness of our products, data validation, our visibility at and sponsorship of conferences and educational events, global business disruption caused by Russia’s invasion of Ukraine and related sanctions, as well as those risk factors described under Part I, Item 1A., “Risk Factors,” of our Annual Report on Form 10-K for the most recently ended fiscal year. 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.

Contact:
Axogen, Inc.
InvestorRelations@axogeninc.com

Media Inquiries:
Ignacio Guerrero-Ross, Ph.D.
Russo Partners
646.942.5604
ignacio.guerrero-ros@russopartnersllc.com


Primary Logo

Source: Axogen, Inc. ]]>
Axogen to Participate at Upcoming Investor Conferences https://ir.axogeninc.com/news/detail/963/axogen-to-participate-at-upcoming-investor-conferences Thu, 31 Aug 2023 07:00:00 -0400 https://ir.axogeninc.com/news/detail/963/axogen-to-participate-at-upcoming-investor-conferences ALACHUA and TAMPA, Fla., Aug. 31, 2023 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced that Karen Zaderej, Chairman, Chief Executive Officer, and President, will participate in two investor conferences in September.

  • Zaderej will present at the H.C. Wainwright 25th Annual Global Investment Conference in New York, NY on Monday, September 11, 2023 at 8:30 a.m. ET.

  • Zaderej will participate in a fireside chat at the 2023 Cantor Fitzgerald Global Healthcare Conference in New York, NY on Thursday, September 28, 2023 at 8:35 a.m. ET.

Webcast events can be accessed live through the Investors page at www.axogeninc.com. For those not available to listen to the live broadcast, the 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 that are used across two primary application categories: scheduled, non-trauma procedures and emergent trauma procedures. Scheduled procedures are generally characterized as those where a patient is seeking relief from conditions caused by a nerve defect or surgical procedure. These procedures include providing sensation for women seeking breast reconstruction following a mastectomy, nerve reconstruction following the surgical removal of painful neuromas, oral and maxillofacial procedures, and nerve decompression. Emergent procedures are generally characterized as procedures resulting from injuries that initially present in an ER. These procedures are typically referred to and completed by a specialist either immediately or within a few days following the initial injury.

Axogen’s product portfolio includes 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 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 HA+ Nerve Protector, a porcine submucosa ECM base layer coated with a proprietary hyaluronate-alginate gel, a next-generation technology designed to provide short- and long-term protection for peripheral nerve injuries; and 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. The Axogen portfolio of products is available in the United States, Canada, Germany, the United Kingdom, Spain, South Korea, and several other countries.

Contact:
Axogen, Inc.
InvestorRelations@axogeninc.com


Primary Logo

Source: Axogen, Inc. ]]>
Axogen, Inc. Begins Processing Avance® Nerve Graft at New State-of-the-Art Facility in Dayton, Ohio https://ir.axogeninc.com/news/detail/962/axogen-inc-begins-processing-avance-nerve-graft-at-new-state-of-the-art-facility-in-dayton-ohio Mon, 21 Aug 2023 07:00:00 -0400 https://ir.axogeninc.com/news/detail/962/axogen-inc-begins-processing-avance-nerve-graft-at-new-state-of-the-art-facility-in-dayton-ohio ALACHUA, Fla. and TAMPA, Fla., Aug. 21, 2023 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced the successful first week of processing for Avance Nerve Graft at the newly opened Axogen Processing Center (APC), in Dayton, Ohio.

“We are pleased to mark this significant milestone as we begin processing Avance Nerve Graft in our new APC facility,” commented Karen Zaderej, Axogen's Chairman, CEO, and President. “The APC is a world-class tissue processing center that will support our Biologics License Application (BLA) submission in the first half of 2024 and our long-term growth. The BLA will further solidify our leadership in the nerve market, as we continue to provide surgeons and their patients with improved quality-of-life solutions for nerve-related challenges.”

The commencement of Avance processing in the APC is an important step towards the biologics validation that will support the submission of the BLA. The new 107,000 square feet facility includes ISO14644 clean rooms, internal quality labs, a surgeon and tissue agency training lab, and state-of-the-art support systems and redundancies required of high-quality, biologic processes. The APC provides up to three times the current processing capacity and was designed for future growth and expansion.

“The local team in Dayton has done an impressive job in the construction of this world-class processing center,” remarked Todd Puckett, Vice President, Manufacturing. “We have assembled an excellent team of nearly 100 employees who are deeply committed to honoring the gift of tissue donation as we continue to revolutionize the science of nerve repair. We also appreciate our partnership with the State of Ohio, the City of Vandalia, and the Dayton Development Coalition for their support in the development of the APC.”

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 that are used across two primary application categories: scheduled, non-trauma procedures and emergent trauma procedures. Scheduled procedures are generally characterized as those where a patient is seeking relief from conditions caused by a nerve defect or surgical procedure. These procedures include providing sensation for women seeking breast reconstruction following a mastectomy, nerve reconstruction following the surgical removal of painful neuromas, oral and maxillofacial procedures, and nerve decompression. Emergent procedures are generally characterized as procedures resulting from injuries that initially present in an ER. These procedures are typically referred to and completed by a specialist either immediately or within a few days following the initial injury.

Axogen’s product portfolio includes 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 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 HA+ Nerve Protector™, a porcine submucosa ECM base layer coated with a proprietary hyaluronate-alginate gel, a next-generation technology designed to provide short- and long-term protection for peripheral nerve injuries; and 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. The Axogen portfolio of products is available in the United States, Canada, Germany, the 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. Forward-looking statements include statements on the timetable for the BLA submission in the first half of 2024, the role of the APC in supporting the BLA submission, future APC capacity and expansion capabilities, and statements on future growth. Actual results or events could differ materially from those described in any forward-looking statements as a result of various factors, including, without limitation, statements related to the continued impact of COVID-19, global supply chain issues, record inflation, hospital staffing issues, product development, product potential, expected clinical enrollment timing and outcomes, regulatory process and approvals, APC renovation timing and expense, financial performance, sales growth, surgeon and product adoption, market awareness of our products, data validation, our visibility at and sponsorship of conferences and educational events, global business disruption caused by Russia’s invasion of Ukraine and related sanctions, as well as those risk factors described under Part I, Item 1A., “Risk Factors,” of our Annual Report on Form 10-K for the most recently ended fiscal year. 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.

Contact:
Axogen, Inc.
InvestorRelations@axogeninc.com

Media Inquiries:
Ignacio Guerrero-Ross, Ph.D.
Russo Partners
646.942.5604
ignacio.guerrero-ros@russopartnersllc.com


Primary Logo

Source: Axogen, Inc. ]]>
Axogen, Inc. Reports 2023 Second Quarter Financial Results https://ir.axogeninc.com/news/detail/961/axogen-inc-reports-2023-second-quarter-financial-results Mon, 07 Aug 2023 16:01:00 -0400 https://ir.axogeninc.com/news/detail/961/axogen-inc-reports-2023-second-quarter-financial-results ALACHUA, Fla. and TAMPA, Fla., Aug. 07, 2023 (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, 2023.

Second Quarter Financial Results and Business Highlights

  • Revenue was $38.2 million during the second quarter, an increase of approximately 11% over the second quarter of 2022.
  • The Company estimates that revenues from scheduled non-trauma procedures represented approximately half of total revenues during the second quarter and grew over 20% from the second quarter of 2022.
  • The Company estimates that revenues from emergent trauma procedures represented approximately half of total revenues during the second quarter and grew in the low single digit range versus the second quarter of 2022.
  • Gross margin was 81.1% for the quarter, compared to 81.8% in the second quarter of 2022.
  • Net loss of $6.7 million, or $0.16 per share, compared to net loss of $7.7 million, or $0.18 per share in the second quarter of 2022.
  • Adjusted net loss of $1.3 million, or $0.03 per share, compared to adjusted net loss of $2.6 million, or $0.05 per share, in the second quarter of 2022.
  • Adjusted EBITDA loss of $0.2 million, compared to an adjusted EBITDA loss of $1.6 million in the second quarter of 2022.
  • The balance of all cash and cash equivalents and investments on June 30, 2023, was $40.8 million, as compared to $44.1 million on March 31, 2023. The net change includes capital expenditures of $3.6 million related to the construction of the Company's new processing facility in Dayton, OH, partially offset by $0.3 million of net positive other operating cash flow in the quarter.
  • The Company successfully initiated the pilot launch of the Axoguard HA+ Nerve Protector™ in the second quarter and will fully launch this extension of its nerve protection platform later this month.
  • On August 2nd the Phase 3 RECON study was published online in The Journal of Hand Surgery. The Company had previously announced in May of 2022 that RECON had met its primary endpoint. The publication includes the authors analysis of the results, which found that Avance returned a greater degree of functional recovery than conduits and superiority was demonstrated as gap lengths increased.

"We are encouraged by the continued momentum of our overall business, which was led by over 20% growth of scheduled procedures," stated Karen Zaderej, AxoGen's Chairman, CEO, and President. "The strength of our scheduled procedures category is delivering on the Company’s underlying goal of gaining deeper surgeon adoption and expanded use cases of our products across our core and active accounts."

"Emergent trauma procedures continue to experience headwinds as hospitals prioritize resources and address operating challenges particularly with routine trauma procedures. We believe that these challenges are transient and that recent clinical publications, demonstrating the clinical effectiveness, cost, and surgical time efficiencies of allograft nerve repairs, will support continued surgeon adoption and expansion of the trauma category,” continued Zaderej.

  • Core Accounts totaled 347, an increase of 16% over an adjusted* prior-year level of 299, and a decrease of 1% sequentially. Revenue from Core Accounts continued to represent approximately 60% of total revenue.
  • Active Accounts totaled 974, an increase of 4% over an adjusted* prior-year level of 941, and a decrease of 1% sequentially. Revenue from the top 10% of Active Accounts represents approximately 35% of total revenue.
  • Ended the quarter with over 200 peer-reviewed clinical publications featuring Axogen’s nerve repair product portfolio.
  • We ended the quarter with 115 direct sales representatives compared to 116 on March 31, 2023 and a year ago.

Update on Axogen Processing Center (APC) and BLA Submission

The Company completed construction of the APC and in the second quarter placed into service the warehouse and office spaces, and now expects to begin processing tissue in the new facility later this month. The Company will include tissue processing information from the APC in its submission of the BLA for Avance Nerve Graft. Additionally, the Company will be requesting to utilize a rolling submission process with the FDA at a pre-BLA meeting that is expected to occur early first quarter of 2024. If the FDA agrees, the Company expects to begin the submission in the first quarter of 2024 and complete the submission in the second quarter of 2024. The company believes this process will support BLA approval in the first half 2025.

Axoguard HA+ Nerve Protector Launch

The Company successfully initiated the pilot launch of the Axoguard HA+ Nerve Protector™ in the second quarter and will fully launch this extension of its nerve protection platform later this month. Axoguard HA+ Nerve Protector is a proprietary nerve protection device designed to provide short- and long-term protection for peripheral nerve injuries. The device is comprised of a processed porcine submucosa extracellular matrix (ECM) base layer with a hyaluronate-alginate gel coating. The gel layer facilitates enhanced nerve gliding to aid in minimizing soft tissue attachments, while the base layer is remodeled into a long-term protective tissue layer. It is available in a variety of sizes to meet patients' and surgeons' needs.

2023 Financial Guidance

Management is maintaining full-year 2023 revenue guidance in the range of $154 million to $159 million, which represents annual growth of 11% - 15%. The Company anticipates that gross margin will be reduced with the transition to the new processing facility in the third and fourth quarters and that gross margins for the full year 2023 will be approximately 80%.

*The Company voluntarily suspended market availability of Avive® Soft Tissue Membrane on June 1, 2021; and therefore, no Avive revenue was recorded in 2022. Core and Active Account metrics for prior periods were adjusted for Avive revenue. For a reconciliation of adjusted Core and Active Account numbers, please see our Corporate Presentation on the investors page on www.axogeninc.com

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 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 under Investors.

About RECON

RECON is a multicenter, prospective, randomized, subject and evaluator blinded comparative clinical study of nerve cuffs (manufactured conduits) and Avance® Nerve Graft, evaluating recovery outcomes for the repair of nerve discontinuities. The phase 3 pivotal study is designed to provide clinical evidence for the Company’s BLA filing to transition the Company’s Avance Nerve Graft from a section 361 tissue product to a section 351 biologic product; and, as such was designed to test for non-inferiority between static two-point discrimination outcomes for Avance Nerve Graft and manufactured conduit. The study design also allows for a sequential test for superiority of Avance Nerve Graft, following the non-inferiority analysis.

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.

A 2010 written agreement between the FDA and Axogen allows the company to continue marketing Avance as a section 361 Human Cells, Tissues and Cellular and Tissue Based Product (HCT/P) while taking the necessary steps to file a Biologics License Application (BLA) under section 351.

In 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 that are used across two primary application categories: scheduled, non-trauma procedures and emergent trauma procedures. Scheduled procedures are generally characterized as those where a patient is seeking relief from conditions caused by a nerve defect or surgical procedure. These procedures include providing sensation for women seeking breast reconstruction following a mastectomy, nerve reconstruction following the surgical removal of painful neuromas, oral and maxillofacial procedures, and nerve decompression. Emergent procedures are generally characterized as procedures resulting from injuries that initially present in an ER. These procedures are typically referred to and completed by a specialist either immediately or within a few days following the initial injury.

Axogen’s product portfolio includes 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 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 HA+ Nerve Protector™, a porcine submucosa ECM base layer coated with a proprietary hyaluronate-alginate gel, a next-generation technology designed to provide short- and long-term protection for peripheral nerve injuries; and 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. The Axogen portfolio of products is available in the United States, Canada, Germany, the 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. Forward-looking statements include statements about (i) fully launching Axoguard HA+ later this month, (ii) anticipated timetable for seeking approval of the rolling BLA submission in early first quarter of 2024, (iii) subject to approval of the rolling submission, anticipated timetable for the initial BLA submission in the first quarter of 2024 and completion in the second quarter of 2024, (iv) potential BLA approval in the first half of 2025, and (v) initial processing of tissue in the new facility later this month, as well as statements under the subheading "2023 Financial Guidance." Actual results or events could differ materially from those described in any forward-looking statements as a result of various factors, including, without limitation, statements related to the continued impact of COVID-19, global supply chain issues, record inflation, hospital staffing issues, product development, product potential, expected clinical enrollment timing and outcomes, regulatory process and approvals, APC renovation timing and expense, financial performance, sales growth, surgeon and product adoption, market awareness of our products, data validation, our visibility at and sponsorship of conferences and educational events, global business disruption caused by Russia’s invasion of Ukraine and related sanctions, as well as those risk factors described under Part I, Item 1A., “Risk Factors,” of our Annual Report on Form 10-K for the most recently ended fiscal year. 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.

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, and 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 Loss and Adjusted Net 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 the non-GAAP measures to the most directly comparable financial measures calculated and presented in accordance with GAAP 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, the Company’s cash available for operations, and the Company’s ability to meet future capital expenditure and working capital requirements.

Contact:
Axogen, Inc.
InvestorRelations@axogeninc.com


 
Axogen, Inc.
Condensed Consolidated Balance Sheets
(unaudited)
(In thousands, except share and per share amounts)
 
June 30,
2023
  December 31,
2022
Assets  
Current assets:  
Cash and cash equivalents $         23,219     $         15,284  
Restricted cash           6,252               6,251  
Investments           11,312               33,505  
Accounts receivable, net of allowance for doubtful accounts of $595 and $650, respectively           21,573               22,186  
Inventory           21,237               18,905  
Prepaid expenses and other           2,583               1,944  
Total current assets           86,176               98,075  
Property and equipment, net           87,459               79,294  
Operating lease right-of-use assets           13,958               14,369  
Intangible assets, net           4,048               3,649  
Total assets $         191,641     $         195,387  
     
Liabilities and shareholders’ equity      
Current liabilities:      
Accounts payable and accrued expenses $         22,893     $         22,443  
Current maturities of long-term lease obligations           1,040               1,310  
Total current liabilities           23,933               23,753  
     
Long-term debt, net of debt discount and financing fees           46,154               45,712  
Long-term lease obligations           20,131               20,405  
Debt derivative liabilities           4,271               4,518  
Total liabilities           94,489               94,388  
     
Commitments and contingencies - see Note 12      
     
Shareholders’ equity:      
Common stock, $0.01 par value per share; 100,000,000 shares authorized; 42,979,541 and 42,445,517 shares issued and outstanding           430               424  
Additional paid-in capital           370,036               360,155  
Accumulated deficit           (273,314 )             (259,580 )
Total shareholders’ equity           97,152               100,999  
Total liabilities and shareholders’ equity $         191,641     $         195,387  

 
Axogen, Inc.
Condensed Consolidated Statements of Operation
(unaudited)
(In thousands, except per share amounts)
 
Three Months Ended   Six Months Ended
June 30,
2023
  June 30,
2022
  June 30,
2023
  June 30,
2022
             
Revenues $         38,155     $         34,454     $         74,819     $         65,461  
Cost of goods sold           7,228               6,284               13,937               11,830  
Gross profit           30,927               28,170               60,882               53,631  
Costs and expenses:              
Sales and marketing           20,838               19,669               42,456               40,557  
Research and development           7,363               7,022               14,043               13,296  
General and administrative           9,628               9,403               18,627               19,021  
Total costs and expenses           37,829               36,094               75,126               72,874  
Loss from operations           (6,902 )             (7,924 )             (14,244 )             (19,243 )
Other income (expense):              
Investment income (loss)           235               32               784               (15 )
Interest expense           (148 )             (249 )             (164 )             (603 )
Change in fair value of derivatives           432               434               247               686  
Other expense           (277 )             (33 )             (357 )             (40 )
Total other income, net           242               184               510               28  
Net loss $         (6,660 )   $         (7,740 )   $         (13,734 )   $         (19,215 )
               
Weighted average common shares outstanding — basic and diluted           42,862,384               41,994,618               42,719,096               41,900,000  
Loss per common share — basic and diluted $         (0.16 )   $         (0.18 )   $         (0.32 )   $         (0.46 )

 
Axogen, Inc.
RECONCILIATION OF GAAP FINANCIAL MEASURES TO NON-GAAP FINANCIAL MEASURES
Three Months Ended March 31, 2023 and 2022
(unaudited)
(In thousands, except per share amounts)
 
  Three Months Ended   Six Months Ended
  June 30,
2023
  June 30,
2022
  June 30,
2023
  June 30,
2022
               
Net loss $         (6,660 )   $         (7,740 )   $         (13,734 )   $         (19,215 )
Depreciation and amortization expense           871               777               1,650               1,550  
Investment (income) loss           (235 )             (32 )             (784 )             15  
Income tax expense           240               33               318               33  
Interest expense           148               249               164               603  
EBITDA - non GAAP $         (5,636 )   $         (6,713 )   $         (12,386 )   $         (17,014 )
               
Non cash stock-based compensation expense           5,390               4,910               8,344               7,588  
Litigation and related costs           —               216               —               483  
Adjusted EBITDA - non GAAP $         (246 )   $         (1,587 )   $         (4,042 )   $         (8,943 )
               
Net loss $         (6,660 )   $         (7,740 )   $         (13,734 )   $         (19,215 )
Non cash stock-based compensation expense           5,390               4,910               8,344               7,588  
Litigation and related costs           —               216               —               483  
Adjusted net loss - non GAAP $         (1,270 )   $         (2,614 )   $         (5,390 )   $         (11,144 )
               
Weighted average common shares outstanding — basic and diluted           42,862,384               41,994,618               42,719,096               41,900,000  
               
Loss per common share — basic and diluted $         (0.16 )   $         (0.18 )   $         (0.32 )   $         (0.46 )
Non cash stock-based compensation expense           0.13               0.12     $         0.20     $         0.18  
Litigation and related costs           —               0.01     $         —     $         0.01  
Adjusted net loss per common share — basic and diluted - non GAAP $         (0.03 )   $         (0.05 )   $         (0.12 )   $         (0.27 )


 
Axogen, Inc.
Condensed Consolidated Statements of Changes in Shareholders’ Equity
(unaudited)
(In thousands, except share amounts)
               
Common Stock   Additional Paid-in
Capital
  Accumulated
Deficit
  Total Shareholders'
Equity
Shares
  Amount      
Three Months Ended June 30, 2023          
Balance at March 31, 2023         42,809,994     $         428     $         363,739     $         (266,654 )   $         97,513  
Net loss         —               —               —               (6,660 )             (6,660 )
Stock-based compensation         —               —               5,390               —               5,390  
Issuance of restricted and performance stock units         57,659               1               (1 )             —               —  
Exercise of stock options and employee stock purchase plan         111,888               1               908               —               909  
Balance at June 30, 2023         42,979,541     $         430     $         370,036     $         (273,314 )   $         97,152  
                   
Six Months Ended June 30, 2023                    
Balance at December 31, 2022         42,445,517     $         424     $         360,155     $         (259,580 )   $         100,999  
Net loss         —               —               —               (13,734 )             (13,734 )
Stock-based compensation         —               —               8,344               —               8,344  
Issuance of restricted and performance stock units         296,378               4               (4 )             —               —  
Exercise of stock options and employee stock purchase plan         237,646               2               1,541               —               1,543  
Balance at June 30, 2023         42,979,541     $         430     $         370,036     $         (273,314 )   $         97,152  
                     
Three Months Ended June 30, 2022                    
Balance at March 31, 2022         41,972,987     $         420     $         345,538     $         (242,107 )   $         103,851  
Net loss         —               —               —               (7,740 )             (7,740 )
Stock-based compensation                 —               4,910               —               4,910  
Issuance of restricted and performance stock units         44,054               —               —               —               —  
Exercise of stock options and employee stock purchase plan         117,463               —               669               —               669  
Balance at June 30, 2022         42,134,504     $         420     $         351,117     $         (249,847 )   $         101,690  
                     
Six Months Ended June 30, 2022                    
Balance at December 31, 2021         41,736,950     $         417     $         342,765     $         (230,632 )   $         112,550  
Net loss         —               —               —               (19,215 )             (19,215 )
Stock-based compensation         —               —               7,588               —               7,588  
Issuance of restricted and performance stock units         259,341               2               (2 )             —               —  
Exercise of stock options and employee stock purchase plan         138,213               1               766               —               767  
Balance at June 30, 2022         42,134,504     $         420     $         351,117     $         (249,847 )   $         101,690  


 
Axogen, Inc.
Condensed Consolidated Statements of Cash Flows
(unaudited)
(In Thousands)
 
Six Months Ended
June 30,
2023
  June 30,
2022
Cash flows from operating activities:      
  $         (13,734 )   $         (19,215 )
Adjustments to reconcile net loss to net cash used in operating activities:      
Depreciation           1,506               1,418  
Amortization of right-of-use assets           642               859  
Amortization of intangible assets           144               132  
Amortization of debt discount and deferred financing fees           442               442  
Provision for bad debt           (37 )             550  
Provision for inventory write-down           1,052               928  
Change in fair value of derivatives           (247 )             (686 )
Investment (income) loss           (578 )             145  
Stock-based compensation           8,344               7,588  
Change in operating assets and liabilities:      
Accounts receivable           650               (2,719 )
Inventory           (3,384 )             (3,458 )
Prepaid expenses and other           (639 )             (1,081 )
Accounts payable and accrued expenses           (529 )             (786 )
Operating lease obligations           (762 )             (856 )
Cash paid for interest portion of finance leases           (1 )             —  
Net cash used in operating activities           (7,131 )             (16,739 )
Cash flows from investing activities:      
Purchase of property and equipment           (8,719 )             (9,086 )
Purchase of investments           (10,203 )             (6,024 )
Proceeds from sale of investments           32,974               11,000  
Cash payments for intangible assets           (516 )             (852 )
Net cash from (used in) investing activities           13,536               (4,962 )
Cash flows from financing activities:      
Cash paid for debt portion of finance leases           (12 )             (1 )
Proceeds from exercise of stock options and ESPP stock purchases           1,543               767  
Net cash provided by financing activities           1,531               766  
Net increase (decrease) in cash, cash equivalents, and restricted cash           7,936               (20,935 )
Cash, cash equivalents, and restricted cash, beginning of period           21,535               39,007  
Cash, cash equivalents, and restricted cash, end of period $         29,471     $         18,073  
Supplemental disclosures of cash flow activity:      
Cash paid for interest, net of capitalized interest $         —     $         —  
Supplemental disclosure of non-cash investing and financing activities:      
Acquisition of fixed assets in accounts payable and accrued expenses $         1,818     $         1,817  
Obtaining a right-of-use asset in exchange for a lease liability $         268     $         700  
Acquisition of intangible assets in accounts payable and accrued expenses $         326     $         186  

 


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Source: Axogen, Inc. ]]>
Axogen to Participate at Canaccord Genuity’s 43rd Annual Growth Conference https://ir.axogeninc.com/news/detail/960/axogen-to-participate-at-canaccord-genuitys-43rd-annual-growth-conference Thu, 27 Jul 2023 07:00:00 -0400 https://ir.axogeninc.com/news/detail/960/axogen-to-participate-at-canaccord-genuitys-43rd-annual-growth-conference ALACHUA and TAMPA, Fla., July 27, 2023 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced that Karen Zaderej, Chairman, Chief Executive Officer, and President, will participate in a fireside chat at Canaccord Genuity’s 43rd Annual Growth Conference in Boston, MA, on Wednesday, August 9, 2023, at 2 p.m. ET.

The webcast can be accessed live through the Investors page at www.axogeninc.com. For those not available to listen to the live broadcast, the 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 HA+ Nerve Protector™, a porcine submucosa ECM base layer coated with a proprietary hyaluronate-alginate gel, is a next-generation technology designed to provide short- and long-term protection for peripheral nerve injuries; and 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. The Axogen portfolio of products is available in the United States, Canada, Germany, the United Kingdom, Spain, South Korea, and several other countries.

Contact:
Axogen, Inc.
InvestorRelations@axogeninc.com


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Axogen, Inc. to report second quarter 2023 financial results and host conference call on August 7, 2023 https://ir.axogeninc.com/news/detail/959/axogen-inc-to-report-second-quarter-2023-financial-results-and-host-conference-call-on-august-7-2023 Wed, 26 Jul 2023 07:00:00 -0400 https://ir.axogeninc.com/news/detail/959/axogen-inc-to-report-second-quarter-2023-financial-results-and-host-conference-call-on-august-7-2023 ALACHUA, Fla. and TAMPA, Fla., July 26, 2023 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced that it will report second quarter 2023 financial results on Monday, August 7, 2023 after the market closes. Axogen management will host an investment-community conference call and webcast at 4:30 p.m. ET following the release.

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 HA+ Nerve Protector™, a porcine submucosa ECM base layer coated with a proprietary hyaluronate-alginate gel, is a next-generation technology designed to provide short- and long-term protection for peripheral nerve injuries; and 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. The Axogen portfolio of products is available in the United States, Canada, Germany, the United Kingdom, Spain, South Korea, and several other countries.

Contact:
Axogen, Inc.
InvestorRelations@axogeninc.com


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Source: Axogen, Inc. ]]>
Axogen to Participate at Jefferies Healthcare Conference https://ir.axogeninc.com/news/detail/958/axogen-to-participate-at-jefferies-healthcare-conference Wed, 24 May 2023 07:00:00 -0400 https://ir.axogeninc.com/news/detail/958/axogen-to-participate-at-jefferies-healthcare-conference ALACHUA, Fla. and TAMPA, Fla., May 24, 2023 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced that Karen Zaderej, Chairman, Chief Executive Officer, and President, will participate in a fireside chat at the Jefferies Healthcare Conference in New York, NY, on Wednesday, June 7, 2023 at 8:30 a.m. ET.

The webcast can be accessed live through the Investors page at www.axogeninc.com. For those not available to listen to the live broadcast, the 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 HA+ Nerve Protector™, a porcine submucosa ECM base layer coated with a proprietary hyaluronate-alginate gel, is a next-generation technology designed to provide short- and long-term protection for peripheral nerve injuries; and 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. The Axogen portfolio of products is available in the United States, Canada, Germany, the United Kingdom, Spain, South Korea, and several other countries.

Contact:
Russo Partners, LLC
Adanna G. Alexander, Investor Relations
adanna.alexander@russopartnersllc.com


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