Axogen, Inc. Reports 2021 Fourth Quarter and Full-Year Financial Results


ALACHUA, Fla. and TAMPA, Fla., Feb. 22, 2022 (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, 2021.

Fourth Quarter 2021 and Business Highlights

  • Net revenue was $31.5 million during the fourth quarter, a 3% decrease compared to fourth-quarter 2020 revenue of $32.5 million.
  • Fourth quarter revenue includes $0.5 million from the reversal of a sales return reserve recorded in the second quarter of 2021 for Avive® Soft Tissue Membrane, for which the company voluntarily suspended market availability on June 1, 2021. Avive revenue in the fourth quarter of 2020 was approximately $1.6 million.
  • Gross margin was 82.8% for the quarter compared to 83.2% in the fourth quarter of 2020.
  • Adjusted net loss was $3.3 million for the quarter, or $0.08 per share, for both the fourth quarter of 2021 and 2020.
  • Adjusted EBITDA loss was $1.7 million for the quarter, compared to an adjusted EBITDA loss of $1.3 million in the fourth quarter of 2020.
  • The balance of all cash, cash equivalents, and investments on December 31, 2021 was $90.3 million, compared to a balance of $98.1 million on September 30, 2021. The net change includes capital expenditures of $5.8 million related to the construction of our new processing facility in Dayton, OH, and $1.9 million of operating cash burn in the quarter.
  • Core Accounts as of December 31, 2021 were 294, a 9% increase compared to 269 as of December 31, 2020. Revenue from Core Accounts continued to represent approximately 60% of total revenue.
  • Active Accounts as of December 31, 2021 were 951, a 6% increase from 893 as of December 31, 2020. Revenue from the top 10% of Active Accounts continued to represent approximately 35% of total revenue.

“I am pleased with our full-year results in light of a difficult operating environment in the second half of the year,” commented Karen Zaderej, chairman, CEO, and president of Axogen, Inc. “We believe more surgeons and accounts are recognizing the value Axogen provides, and we enter 2022 with a strong commercial organization and a solid foundation of clinical evidence. We look forward to the release of the topline results of our RECON study in the second quarter and returning to a more normalized growth environment through the year.”

Full-Year 2021 Financial Results and Business Highlights

  • Full-year 2021 revenue was $127.4 million, a 13% increase compared to 2020 revenue of $112.3 million.
  • Avive revenue totaled approximately $4.1 million and $5.5 million for the years ended 2021 and 2020, respectively.
  • Gross margin was 82.0% for the full year, compared to 80.8% in 2020.
  • Adjusted net loss was $13.7 million for the full year, or $0.33 per share, compared to $15.3 million, or $0.38 per share, in 2020.
  • Adjusted EBITDA loss was $6.7 million for the full year, compared to an adjusted EBITDA loss of $11.1 million in 2020.
  • Ended the year with 115 direct sales representatives, compared to 111 at the end of 2020.
  • Ended the year with 181 peer-reviewed clinical publications featuring Axogen’s nerve repair product portfolio.

2022 Financial Guidance
Management expects 2022 revenue will be in the range of $135.0 million to $142.0 million. This represents approximately 10% to 15% growth over 2021 revenue excluding the impact of $4.1 million of Avive revenue in 2021. Full-year 2022 gross margin is expected to be above 80%.

Conference Call
The Company will host a conference call and webcast for the investment community today at 4:30 p.m. ET. Investors interested in participating by phone are invited to call toll free at 1-877-407-0993 or use the direct dial-in number 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 the RECON Clinical Study
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 test for non-inferiority between the 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 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; 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. The forward-looking statements may include, without limitation, statements related to the impact of COVID-19 on our business, hospital staffing challenges and its impact on our business, statements regarding our growth, our financial guidance and performance, product development, product potential, regulatory process and approvals, APC renovation timing and expense, sales growth, product adoption, market awareness of our products, anticipated capital requirements, including the potential of future financings, data validation, expected clinical study enrollment, timing and outcomes, our assessment of our internal controls over financial reporting, our visibility at and sponsorship of conferences and our educational events, regulatory process and approvals and other factors, including legislative, regulatory, political and economic developments not within our control. The forward-looking statements are and will be subject to risks and uncertainties, which may cause actual results to differ materially from those expressed or implied in such forward-looking statements. Forward-looking statements contained in this press release should be evaluated together with the many uncertainties that affect our business and our market, particularly those 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, as well as other risks and cautionary statements set forth in our filings with the U.S. Securities and Exchange Commission. Forward-looking statements are not a guarantee of future performance, and actual results may differ materially from those projected. The forward-looking statements are representative only as of the date they are made and, except as required by applicable law, we assume no responsibility to publicly update or revise any forward-looking statements, whether as a result of new information, future events, changed circumstances, or otherwise

Contact:
Axogen, Inc.
Ed Joyce, Director, Investor Relations
ejoyce@axogeninc.com
InvestorRelations@axogeninc.com

 
AXOGEN, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)
(In Thousands, Except Share and Per Share Amounts)
     
  December 31,December 31,
   2021  2020 
Assets    
Current assets:    
Cash and cash equivalents $32,756  $48,767 
Restricted cash  6,251   6,842 
Investments  51,330   55,199 
Accounts receivable, net  18,158   17,618 
Inventory  16,693   12,529 
Prepaid expenses and other  1,861   4,296 
Total current assets  127,049   145,251 
Property and equipment, net  62,881   38,398 
Operating lease right-of-use assets  15,193   15,614 
Finance lease right-of-use assets  42   64 
Intangible assets, net  2,859   2,054 
Total assets $208,024  $201,381 
     
Liabilities and shareholders’ equity    
Current liabilities:    
Accounts payable and accrued expenses $22,459  $21,968 
Current maturities of long-term lease obligations  1,834   863 
Total current liabilities  24,293   22,831 
Long-term debt, net of financing fees  44,821   32,027 
Debt derivative liabilities  5,562   2,497 
Long-term lease obligations  20,798   20,874 
Other long-term liabilities     3 
Total liabilities  95,474   78,232 
Shareholders’ equity:    
Common stock, $.01 par value per share; 100,000,000 shares authorized  417   406 
Additional paid-in capital  342,765   326,390 
Accumulated deficit  (230,632)  (203,647)
Total shareholders’ equity   112,550   123,149 
Total liabilities and shareholders' equity $208,024  $201,381 


AXOGEN, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Three Months and Years Ended December 31, 2021 and 2020
(unaudited)
(In Thousands, Except Per Share Amounts)
         
  Three Months Ended Year Ended
  December 31, December 31, December 31, December 31,
   2021   2020   2021   2020 
Revenues  $31,537  $32,495  $127,358  $112,300 
Cost of goods sold  5,428   5,463   22,931   21,581 
Gross profit  26,109   27,032   104,427   90,719 
Costs and expenses:        
Sales and marketing  17,734   19,805   73,328   69,659 
Research and development  6,302   4,931   24,177   17,846 
General and administrative  7,426   7,670   32,338   26,396 
Total costs and expenses  31,462   32,406   129,843   113,901 
Loss from operations  (5,353)  (5,374)  (25,416)  (23,182)
Other (expense) income:        
Investment income  13   29   93   605 
Interest expense  71   (595)  (1,356)  (1,054)
Change in fair value of derivatives  124   (46)  (28)  (117)
Other expense  (141)  (24)  (278)  (38)
Total other (expense) income, net   67   (636)  (1,569)  (604)
Net loss $(5,286) $(6,010) $(26,985) $(23,786)
         
Weighted average common shares outstanding – basic and diluted  41,593   40,246   41,215   39,967 
Loss per common share – basic and diluted $(0.13) $(0.15) $(0.65) $(0.60)
         
Adjusted net loss - non GAAP $(3,272) $(3,265) $(13,697) $(15,281)
Adjusted loss per common share – basic and diluted $(0.08) $(0.08) $(0.33) $(0.38)


AXOGEN, INC.
RECONCILIATION OF GAAP FINANCIAL MEASURES TO NON-GAAP FINANCIAL MEASURES
Three Months and Years Ended December 31, 2021 and 2020
(unaudited)
(In Thousands, Except Per Share Amounts)
         
  Three Months Ended Year Ended
  December 31, December 31, December 31, December 31,
  2021   2020   2021   2020 
         
Gross profit $26,109  $27,032  $104,427  $90,719 
Avive inventory write-down and production costs  -   -   1,429   - 
Adjusted gross profit $26,109  $27,032  $105,856  $90,719 
         
Net loss $(5,286) $(6,010) $(26,985) $(23,786)
Depreciation and amortization expense  1,563   1,284 (1) 5,572   3,692 
Investment income  (13)  (29)  (93)  (605)
Income tax expense  138   77   205   77 
Interest expense  (71)  595   1,356   1,054 
EBITDA - non GAAP $(3,669) $(4,083)(1)$(19,945) $(19,568)
         
Non cash stock-based compensation expense  1,509   2,745   10,919   8,470 
Litigation and related costs  505      2,369   35 
Adjusted EBITDA - non GAAP $(1,655) $(1,338)(1)$(6,657) $(11,063)
         
Net loss $(5,286) $(6,010) $(26,985) $(23,786)
Non cash stock-based compensation expense  1,509   2,745   10,919   8,470 
Litigation and related costs  505      2,369   35 
Adjusted net loss - non GAAP $(3,272) $(3,265) $(13,697) $(15,281)
Weighted average common shares outstanding – basic and diluted  41,593   40,246   41,215   39,967 
Adjusted loss per common share – basic and diluted $(0.08) $(0.08) $(0.33) $(0.38)
         
(1) The Company has revised its definition of EBITDA and Adjusted EBITDA to include amortization of its right-of-use assets and amortization of debt discount and deferred financing fees. See Reconciliation of Revised EBITDA, Adjusted EBITDA, and Depreciation and Amortization.


AXOGEN, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY
Three Months and Years Ended December 31, 2021 and 2020
(unaudited)
(In Thousands)
           
  Common Stock     Total
  Shares Amount Additional Paid-
in Capital
 Accumulated
Deficit
 Shareholders'
Equity
For the Three Months Ended December 31, 2021:          
Balance at September 30, 2021 41,559  $415  $340,212  $(225,346) $115,281 
Net loss -   -   -   (5,286)  (5,286)
Stock-based compensation -   -   1,509   -   1,509 
Issuance of restricted and performance stock units 48   -   -   -   - 
Exercise of stock options and employee stock purchase plan 130   2   1,044   -   1,046 
Balance at December 31, 2021 41,737  $417  $342,765  $(230,632) $112,550 
           
For the Year Ended December 31, 2021:          
Balance at December 31, 2020 40,619  $406  $326,390  $(203,647) $123,149 
Net loss -   -   -   (26,985)  (26,985)
Stock-based compensation -   -   10,919   -   10,919 
Issuance of restricted and performance stock units 254   2   (2)  -   - 
Exercise of stock options and employee stock purchase plan 864   9   5,458   -   5,467 
Balance at December 31, 2021 41,737  $417  $342,765  $(230,632) $112,550 
           
           
           
For the Three Months Ended December 31, 2020:          
Balance at September 30, 2020 40,124  $401  $318,949  $(197,637) $121,713 
Net loss -   -   -   (6,010)  (6,010)
Stock-based compensation -   -   2,745   -   2,745 
Issuance of restricted and performance stock units 81   -   -   -   - 
Shares surrendered by employees to pay tax withholdings (2)  1   (6)  -   (5)
Exercise of stock options and employee stock purchase plan 168   2   1,022   -   1,024 
Exercise of Oberland option, net of settlement 248   2   3,680   -   3,682 
Balance at December 31, 2020 40,619  $406  $326,390  $(203,647) $123,149 
           
For the Year Ended December 31, 2020:          
Balance at December 31, 2019 39,590  $396  $311,618  $(179,861) $132,153 
Net loss -   -   -   (23,786)  (23,786)
Stock-based compensation -   -   8,470   -   8,470 
Issuance of restricted and performance stock units 249   2   (2)  -   - 
Shares surrendered by employees to pay tax withholdings (40)  -   (670)  -   (670)
Exercise of stock options and employee stock purchase plan 572   6   3,294   -   3,300 
Exercise of Oberland option, net of settlement 248   2   3,680   -   3,682 
Balance at December 31, 2020 40,619  $406  $326,390  $(203,647) $123,149 


AXOGEN, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
Years Ended December 31, 2021 and 2020
(unaudited)
(In Thousands)
     
  Year Ended
  December 31, December 31,
   2021   2020 
Cash flows from operating activities:    
Net loss $(26,985) $(23,786)
Adjustments to reconcile net loss to net cash used in operating activities:    
Depreciation and amortization  2,721   1,507 
Amortization of right-of-use assets  1,818   1,800 
Amortization of intangible assets  202   153 
Amortization of debt discount and deferred financing fees  831   232 
Loss on disposal of equipment  -   3 
Provision for bad debt  (41)  (105)
Provision for inventory write-down  3,314   2,242 
Change in fair value of deriviatives  28   117 
Investment (gains) losses  68   (47)
Stock-based compensation  10,919   8,470 
Change in operating assets and liabilities:    
Accounts receivable  (499)  (635)
Inventory  (7,478)  (910)
Prepaid expenses and other  2,435   (2,524)
Accounts payable and accrued expenses  (270)  4,958 
Operating lease obligations  (463)  (1,086)
Cash paid for interest portion of finance leases  (2)  (3)
Contract and other liabilities  (3)  (12)
Net cash used in operating activities  (13,405)  (9,626)
     
Cash flows from investing activities:    
Purchase of property and equipment  (27,811)  (21,905)
Economic development grant proceeds  950    
Purchase of investments  (68,699)  (77,806)
Proceeds from sale of investments  72,500   83,440 
Cash payments for intangible assets  (589)  (692)
Net cash used in investing activities  (23,649)  (16,963)
     
Cash flows from financing activities:    
Proceeds from issuance of long-term debt  15,000   35,000 
Proceeds from the paycheck protection program loan     7,820 
Repayment of the paycheck protection program loan     (7,820)
Proceeds from issuance of common stock     3,500 
Payments for debt issuance costs     (642)
Payments of employee tax withholding in exchange of common stock awards     (670)
Cash paid for debt portion of finance leases  (15)  (14)
Proceeds from exercise of stock options and ESPP stock purchases  5,467   3,300 
Net cash provided by financing activities  20,452   40,474 
     
Net (decrease) increase in cash, cash equivalents and restricted cash  (16,602)  13,885 
Cash, cash equivalents and restricted cash, beginning of period  55,609   41,724 
Cash, cash equivalents and restricted cash, end of period $39,007  $55,609 
     
Supplemental disclosures of cash flow activity:    
Cash paid for interest, net of capitalized interest $495  $822 
Supplemental disclosure of non-cash investing and financing activities    
Acquisition of fixed assets in accounts payable and accrued expenses $1,420  $1,077 
Obtaining a right-of-use asset in exchange for a lease liability $1,375  $14,259 
Acquisition of leasehold asset $-  $5,250 
Embedded derivative associated with the long-term debt $3,037  $2,563 
Acquisition of intangible assets in accounts payable and accrued expenses $418  $- 
Conversion of the Oberland option $-  $182 


AXOGEN, INC.
RECONCILIATION OF REVISED EBITDA, ADJUSTED EBITDA, and DEPRECIATION AND AMORTIZATION
Three Months Ended September 30, 2021 and 2020; June 30, 2021 and 2020; March 31, 2021 and 2020; December 31, 2020 and
Year Ended December 31, 2020
(unaudited)
(In Thousands)
           
The Company has revised its definition of EBITDA and Adjusted EBITDA to include amortization of its right-of-use assets and amortization of debt discount and deferred financing fees.
The tables below provide a reconciliation of EBITDA and Adjusted EBITDA as previously reported to the amounts calculated using the new definition.
           
  Three Months Ended    
  March 31, June 30, September 30,    
   2021   2021   2021     
           
Depreciation and amortization expense, as previously reported $818  $661  $706     
Amortization of ROU assets  500   460   458     
Amortization of debt discount and deferred financing fees  112   115   157     
Revised depreciation and amortization expense $1,430  $1,236  $1,321     
           
EBITDA - non GAAP, as previously reported $(5,437) $(6,639) $(6,035)    
Amortization of ROU assets  500   460   458     
Amortization of debt discount and deferred financing fees  112   115   157     
Revised EBITDA - non GAAP $(4,825) $(6,064) $(5,420)    
           
Adjusted EBITDA - non GAAP, as previously reported $(1,906) $(2,435) $(2,496)    
Amortization of ROU assets  500   460   458     
Amortization of debt discount and deferred financing fees  112   115   157     
Revised Adjusted EBITDA - non GAAP $(1,294) $(1,860) $(1,881)    
           
           
  Three Months Ended Year Ended
  March 31, June 30, September 30, December 31, December 31,
   2020   2020   2020   2020   2020 
           
Depreciation and amortization expense, as previously reported $343  $346  $439  $556  $1,660 
Amortization of ROU assets  470   332   480   518   1,800 
Amortization of debt discount and deferred financing fees  -   -   22   210   232 
Revised depreciation and amortization expense $813  $678  $941  $1,284  $3,692 
           
EBITDA - non GAAP, as previously reported $(8,139) $(7,907) $(671) $(4,811) $(21,600)
Amortization of ROU assets  470   332   480   518   1,800 
Amortization of debt discount and deferred financing fees  -   -   22   210   232 
Revised EBITDA - non GAAP $(7,669) $(7,575) $(169) $(4,083) $(19,568)
           
Adjusted EBITDA - non GAAP, as previously reported $(7,583) $(5,685) $2,276  $(2,066) $(13,095)
Amortization of ROU assets  470   332   480   518   1,800 
Amortization of debt discount and deferred financing fees  -   -   22   210   232 
Revised Adjusted EBITDA - non GAAP $(7,113) $(5,353) $2,778  $(1,338) $(11,063)