UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

[X]QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended September 30, 20202021

or

[  ]TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from ___________ to ___________

Commission File Number: 001-34951

XTANT MEDICAL HOLDINGS, INC.

(Exact name of registrant as specified in its charter)

Delaware20-5313323

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

664 Cruiser Lane

Belgrade, Montana

59714
(Address of principal executive offices)(Zip Code)

(406)388-0480

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:

Title of each classTrading Symbol(s)Name of each exchange on which registered
Common stock, par value $0.000001 per shareXTNTNYSE American LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes [X] No [  ]

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes [X] No [  ]

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer [  ]Accelerated filer [  ]
Non-accelerated filer [X]Smaller reporting company [X]
Emerging growth company [  ]

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [  ]

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes [  ] No [X]

Number of shares of common stock, $0.000001 par value, of registrant outstanding at October 27, 2020: 72,061,034.November 9, 2021: 86,796,175.

 

 

 

XTANT MEDICAL HOLDINGS, INC.

FORM 10-Q

September 30, 20202021

TABLE OF CONTENTS

Page
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTSii
PART I.FINANCIAL INFORMATION1
ITEM 1.FINANCIAL STATEMENTS1
ITEM 2.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS1714
ITEM 3.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK2320
ITEM 4.CONTROLS AND PROCEDURES2320
PART II.OTHER INFORMATION2320
ITEM 1.LEGAL PROCEEDINGS2320
ITEM 1A.RISK FACTORS2320
ITEM 2.UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS2422
ITEM 3.DEFAULTS UPON SENIOR SECURITIES2422
ITEM 4.MINE SAFETY DISCLOSURES2422
ITEM 5.OTHER INFORMATION2422
ITEM 6.EXHIBITS2522

This Quarterly Report on Form 10-Q contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbor created by those sections. For more information, see “Cautionary Statement Regarding Forward-Looking Statements.”

As used in this report, references to “Xtant,” the “Company,” “we,” our,” or “us,” unless the context otherwise requires, refer toindicates another meaning, the terms “we,” “us,” “our,” “Xtant,” “Xtant Medical,” and the “Company” mean Xtant Medical Holdings, Inc., and its wholly owned subsidiaries, Xtant Medical, Inc., Bacterin International, Inc., and X-spine Systems, Inc., all of which are consolidated on Xtant’s condensed consolidated financial statements. All intercompany balances and transactions have been eliminated in consolidation.

We own various unregistered trademarks and service marks, including our corporate logo. Solely for convenience, the trademarks and trade names in this report are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the owner of such trademarks and trade names will not assert, to the fullest extent under applicable law, their rights thereto. We do not intend the use or display of other companies’ trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

We include our website address throughout this report for reference only. The information contained on or connected to our website is not incorporated by reference into this report.

i
 

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

The statements contained in this Quarterly Report on Form 10-Q that are not purely historical are forward-looking statements within the meaning of the Private Securities Litigation Reform Act.Act of 1995. Our forward-looking statements include, but are not limited to, statements regarding our “expectations,” “hopes,” “beliefs,” “intentions,” or “strategies” regarding the future. In addition, any statements that refer to projections, forecasts, or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” and “would,” as well as similar expressions, may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward looking. Forward-looking statements in this Form 10-Q may include, for example, statements about:about the topics below and are subject to risks and uncertainties including without limitation those described below:

the effect of the global novel strain of coronavirus (COVID-19) pandemic, and, in particular, the Delta variant and other variants that may arise in the future, on our business, operating results and financial condition, including the reduction in procedures in which our products are used and disruption to our customers, distributors, independent sales representatives, contract manufacturers and suppliers, as well as the global economy, supply chain and financial and credit markets;
the effect of labor and staffing shortages at hospitals and other medical facilities on the number of elective procedures in which our ability to comply with the covenants inproducts are used and our second amended and restated credit agreement;revenues, as well as global labor shortages;
our ability to maintain sufficient liquidity to fund our operations;
our ability to service our debt;
our ability to obtain financing on reasonable terms when needed;
our ability to increase or maintain revenue;revenue or return to pre-COVID-19 revenue levels within an acceptable time period or at all and possible future impairment charges to long-lived assets and goodwill and write-downs of excess inventory if revenues continue to decrease;
the ability of our sales forcepersonnel, including our independent sales agents and distributors, to achieve expected results;
our ability to innovate, develop, introduce and developmarket new products;
our ability to remain competitive;
our ability to obtain donor cadavers for our products;
our reliance on third party suppliers and manufacturers;
our ability to engage and retain qualified technical and sales personnel and members of our management team;
the availabilityour dependence on and ability to retain and recruit independent sales agents and distributors and our dependence on key independent agents for a significant portion of our facilities;revenue;
our ability to retain and expand our agreements with group purchasing organizations and independent delivery networks;
   
 our ability to retain and recruit independent sales agentsexpand our agreements with original equipment manufacturers and the impacteffect of the termination of an advisory agreement with an entity that provided services to some ofthose sales on our customers;business and operating results;
government regulations;our success in implementing key growth initiatives designed to increase our revenue and scale and risks associated with those initiatives, including effects on product sales mix, which may adversely affect our operating results;
our success in implementing inventory reduction initiatives designed to improve our working capital and the effect of those initiatives on our operating results;
our ability to obtain government and third-party coverage and reimbursement for our products;
our ability to obtain and maintain regulatory approvals in the United States and abroad;
the effect of new government regulations and our compliance with government regulations;
our ability to successfully complete and integrate future business combinations or acquisitions;

ii
 

our ability to use our net operating loss carry-forwards to offset future taxable income;
product liability claims and other litigation to which we may be subjected;
product recalls and defects, including the December 2018 recall of our Calix Lumbar Spine Implant System;defects;
timing and results of clinical studies;
our ability to remain accredited with the American Association of Tissue Banks;
our ability to obtain and protect our intellectual property and proprietary rights;
infringement and ownership of intellectual property; and
the availability of our facilities;
our ability to comply with the covenants in our credit agreements;
our ability to maintain sufficient liquidity to fund our operations;
our ability to service our debt;
our ability to obtain financing on reasonable terms when needed; and
our ability to maintain our stock listing on the NYSE American Exchange.

The forward-looking statements contained in this Form 10-Q are based on our current expectations and beliefs concerning future developments and their potential effects on us. There can be no assurance that future developments affecting us will be those that we have anticipated. These forward-looking statements involve a number of risks, uncertainties, or assumptions, many of which are beyond our control, which may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those factors described in the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 20192020 and this Form 10-Q.

Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required under applicable securities laws.

iiiii
 

 

PARTI. FINANCIAL INFORMATION

PART I. FINANCIAL INFORMATION

ITEM 1.1. FINANCIAL STATEMENTS

XTANT MEDICAL HOLDINGS, INC.

Condensed Consolidated Balance Sheets

(In thousands, except number of shares and par value)

 

As of

September 30, 2020

 

As of

December 31, 2019

  

As of

September 30, 2021

 

As of

December 31, 2020

 
 (Unaudited)     (Unaudited)    
ASSETS                
Current Assets:                
Cash and cash equivalents $2,741  $5,237  $18,175  $2,341 
Trade accounts receivable, net of allowance for credit losses of $746 and doubtful accounts of $500, respectively  7,317   10,124 
Restricted cash  439    
Trade accounts receivable, net of allowance for credit losses and doubtful accounts of $576 and $653, respectively  6,321   6,880 
Inventories  20,671   16,101   19,708   21,408 
Prepaid and other current assets  1,656   784   945   736 
Total current assets  32,385   32,246   45,588   31,365 
Property and equipment, net  4,122   4,695   4,971   4,347 
Right-of-use asset, net  1,799   2,100   1,369   1,690 
Goodwill  3,205   3,205   3,205   3,205 
Intangible assets, net  471   515   414   457 
Other assets  412   394   244   402 
Total Assets $42,394  $43,155  $55,791  $41,466 
                
LIABILITIES & STOCKHOLDERS’ EQUITY (DEFICIT)        
LIABILITIES & STOCKHOLDERS’ EQUITY        
Current Liabilities:                
Accounts payable $2,814  $2,188  $2,355  $2,947 
Accrued liabilities  6,043   6,632   4,079   5,462 
Current portion of lease liability  415   394   451   423 
Current portion of financing lease obligations  59   176 
Current portion of finance lease obligations  31   20 
Line of credit  3,488    
Current portion of long-term debt     16,797 
Total current liabilities  9,331   9,390   10,404   25,649 
Long-term Liabilities:                
Lease liability, less current portion  1,417   1,726   961   1,303 
Long-term debt, plus premium and less issuance costs  79,627   76,244 
Finance lease obligation, less current portion  111    
Long-term debt, less issuance costs  11,678    
Total Liabilities  90,375   87,360   23,154   26,952 
Commitments and Contingencies (note 11)        
Commitments and Contingencies (Note 11)  -   - 
Stockholders’ Equity (Deficit):                
Preferred stock, $0.000001 par value; 10,000,000 shares authorized; no shares issued and outstanding      
Common stock, $0.000001 par value; 75,000,000 shares authorized; 13,240,831 shares issued and outstanding as of September 30, 2020 and 13,161,762 shares issued and outstanding as of December 31, 2019      
Preferred stock, $0.000001 par value; 10,000,000 shares authorized; 0 shares issued and outstanding      
Common stock, $0.000001 par value; 300,000,000 shares authorized; 86,796,175 shares issued and outstanding as of September 30, 2021 and 77,573,680 shares issued and outstanding as of December 31, 2020      
Additional paid-in capital  181,649   179,061   265,539   244,850 
Accumulated deficit  (229,630)  (223,266)  (232,902)  (230,336)
Total Stockholders’ Equity (Deficit)  (47,981)  (44,205)
Total Liabilities & Stockholders’ Equity (Deficit) $42,394  $43,155 
Total Stockholders’ Equity  32,637   14,514 
Total Liabilities & Stockholders’ Equity $55,791  $41,466 

See notes to unaudited condensed consolidated financial statements.

1

 

XTANT MEDICAL HOLDINGS, INC.

Condensed Consolidated Statements of Operations

(Unaudited, in thousands, except number of shares and per share amounts)

            
 

Three Months Ended

September 30,

 

Nine Months Ended

September 30,

  

Three Months Ended

September 30,

 

Nine Months Ended

September 30,

 
 2020  2019  2020  2019  2021  2020  2021  2020 
Revenue                         
Orthopedic product sales $13,980  $15,691  $39,207  $47,574  $13,743  $13,980  $41,193  $39,207 
Other revenue  36   30   115   144   34   36   100   115 
Total Revenue  14,016   15,721   39,322   47,718   13,777   14,016   41,293   39,322 
                                
Cost of sales  4,768   5,310   13,913   16,613   6,586   4,768   16,498   13,913 
Gross Profit  9,248   10,411   25,409   31,105   7,191   9,248   24,795   25,409 
                                
Operating Expenses                                
General and administrative  3,042   4,228   10,293   12,866   3,107   3,042   10,307   10,293 
Sales and marketing  5,270   6,685   15,578   19,499   5,267   5,270   15,712   15,578 
Research and development  176   203   529   675   262   176   719   529 
Total Operating Expenses  8,488   11,116   26,400   33,040   8,636   8,488   26,738   26,400 
                                
Income (Loss) from Operations  760   (705)  (991)  (1,935)
(Loss) Income from Operations  (1,445)  760   (1,943)  (991)
                                
Other (Expense) Income                
Other Expense                
Interest expense  (2,097)  (1,185)  (5,258)  (4,504)  (329)  (2,097)  (529)  (5,258)
Other (expense) income  -   34   -   (109)
Total Other Expense  (2,097)  (1,151)  (5,258)  (4,613)  (329)  (2,097)  (529)  (5,258)
                                
Net Loss Before Provision for Income Taxes  (1,337)  (1,856)  (6,249)  (6,548)  (1,774)  (1,337)  (2,472)  (6,249)
                                
Provision for income taxes  (23)  (23)  (68)  (68)  (30)  (23)  (94)  (68)
Net Loss $(1,360) $(1,879) $(6,317) $(6,616) $(1,804) $(1,360) $(2,566) $(6,317)
                                
Net loss per share:                                
Basic $(0.10) $(0.14) $(0.48) $(0.50) $(0.02) $(0.10) $(0.03) $(0.48)
Dilutive $(0.10) $(0.14) $(0.48) $(0.50) $(0.02) $(0.10) $(0.03) $(0.48)
                                
Shares used in the computation:                                
Basic  13,231,823   13,161,762   13,210,386   13,164,694   86,763,210   13,231,823   84,926,656   13,210,386 
Dilutive  13,231,823   13,161,762   13,210,386   13,164,694   86,763,210   13,231,823   84,926,656   13,210,386 

See notes to unaudited condensed consolidated financial statements.

2

XTANT MEDICAL HOLDINGS, INC.

Condensed Consolidated Statements of Equity

(Unaudited, in thousands, except number of shares)

                     
  Common Stock  Additional Paid-In-  Accumulated  

Total

Stockholders’
Equity

 
  Shares  Amount  Capital  Deficit  (Deficit) 
Balance at December 31, 2020  77,573,680  $  $244,850  $(230,336) $14,514 
                     
Private placement of common stock, net of issuance costs of $1,926  8,888,890      12,831      12,831 
Warrants issued in connection with the private placement        5,243      5,243 
Warrants issued in connection with the private placement to placement agents        351      351 
ASU 2016-13 cumulative effect adjustment                    
Withholding of common stock upon vesting of restricted stock units                    
Withholding of common stock upon vesting of restricted stock units, share                    
Common stock issued on vesting of restricted stock units  244,716             
Stock-based compensation        456      456 
Issuance of warrant                    
Gain on debt extinguishment                    
Net loss           (29)  (29)
Balance at March 31, 2021  86,707,286      263,731   (230,365)  33,366 
                     
Stock-based compensation        465      465 
Gain on debt extinguishment        786      786 
Net loss           (733)  (733)
Balance at June 30, 2021  86,707,286      264,982  $(231,098)  33,884 
Common stock issued on vesting of restricted stock units  104,856             
Withholding of common stock upon vesting of restricted stock units  (15,967)     (23)     (23)
Stock-based compensation        580      580 
Net loss           (1,804)  (1,804)
Balance at September 30, 2021  86,796,175  $  $265,539  $(232,902) $32,637 

  Common Stock  Additional Paid-In-  Accumulated  

Total

Stockholders’
Equity

 
  Shares  Amount  Capital  Deficit  (Deficit) 
Balance at December 31, 2019  13,161,762  $  $179,061  $(223,266) $(44,205)
                     
ASU 2016-13 cumulative effect adjustment           (47)  (47)
Common stock issued on vesting of restricted stock units  61,803             
Stock-based compensation        269      269 
Net loss           (2,493)  (2,493)
Balance at March 31, 2020  13,223,565      179,330   (225,806)  (46,476)
                     
Stock-based compensation        220      220 
Issuance of warrant        1,862      1,862 
Net loss           (2,464)  (2,464)
Balance at June 30, 2020  13,223,565     $181,412  $(228,270) $(46,858)
Balance  13,223,565     $181,412  $(228,270) $(46,858)
Stock-based compensation        237      237 
Common stock issued on vesting of restricted stock units  17,266             
Net loss           (1,360)  (1,360)
Balance at September 30, 2020  13,240,831  $  $181,649  $(230,630) $47,981 
Balance  13,240,831  $  $181,649  $(230,630) $47,981 

STOCKHOLDERS’ EQUITY – THREE MONTHS ENDED SEPTEMBER 30

  Common Stock  Additional  Retained  

Total

Stockholders’ Equity

 
  Shares  Amount  Paid-In-Capital  Deficit  (Deficit) 
Balance at June 30, 2019  13,161,762  $  $178,707  $(219,782) $(41,075)
                     
Stock-based compensation        95      95 
Net loss           (1,879)  (1,879)
Balance at September 30, 2019  13,161,762  $  $178,802  $(221,661) $(42,859)
                     
Balance at June 30, 2020  13,223,565  $  $181,412  $(228,270) $(46,858)
                     
Stock-based compensation        237      237 
Common stock issued on vesting of restricted stock units  17,266             
Net loss           (1,360)  (1,360)
Balance at September 30, 2020  13,240,831  $  $181,649  $(229,630) $(47,981)

STOCKHOLDERS’ EQUITY – NINE MONTHS ENDED SEPTEMBER 30

  Common Stock  Additional  Retained  

Total

Stockholders’ Equity

 
  Shares  Amount  Paid-In-Capital  Deficit  (Deficit) 
Balance at December 31, 2018  13,172,179  $  $171,273  $(215,045) $(43,772)
                     
Stock-based compensation        256      256 
Forfeiture of restricted stock  (10,417)            
Debt extinguishment        7,264      7,264 
Issuance of warrant        9      9 
Net loss           (6,616)  (6,616)
Balance at September 30, 2019  13,161,762  $  $178,802  $(221,661) $(42,859)
                     
Balance at December 31, 2019  13,161,762  $  $179,061  $(223,266) $(44,205)
                     
ASU 2016-13 cumulative effect adjustment           (47)  (47)
Common stock issued on vesting of restricted stock units  79,069             
Issuance of warrant        1,862      1,862 
Stock-based compensation        726      726 
Net loss           (6,317)  (6,317)
Balance at September 30, 2020  13,240,831  $  $181,649  $(229,630) $(47,981)

See notes to unaudited condensed consolidated financial statements.

3

 

XTANT MEDICAL HOLDINGS, INC.

Condensed Consolidated Statements of Cash Flows

(Unaudited, in thousands)

      
 

Nine Months Ended

September 30,

  

Nine Months Ended

September 30,

 
 2020  2019  2021  2020 
Operating activities:                
Net loss $(6,317) $(6,616) $(2,566) $(6,317)
Adjustments to reconcile net loss to net cash provided by operating activities:        
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:        
Depreciation and amortization  1,658   2,338   1,041   1,658 
Gain on disposal of fixed assets  (307)  (27)  (164)  (307)
Non-cash interest  5,245   4,467   38   5,245 
Non-cash rent  12   16   8   12 
Stock-based compensation  726   256   1,501   726 
Provision for reserve on accounts receivable  296   453 
Provision for (recoveries) reserve on accounts receivable  (25)  296 
Provision for excess and obsolete inventory  429   517   572   429 
                
Changes in operating assets and liabilities:                
Accounts receivable  2,463   417   584   2,463 
Inventories  (4,999)  760   1,128   (4,999)
Prepaid and other assets  (890)  240   (126)  (890)
Accounts payable  626   (4,216)  (592)  626 
Accrued liabilities  (589)  1,053   (1,383)  (589)
Net cash (used in) provided by operating activities  (1,647)  (342)
Net cash provided by (used in) operating activities  16   (1,647)
                
Investing activities:                
Purchases of property and equipment and intangible assets  (907)  (403)  (1,489)  (907)
Proceeds from sale of fixed assets  173   241   194   173 
Net cash used in investing activities  (734)  (162)  (1,295)  (734)
                
Financing activities:                
Payment of taxes from withholding of common stock on vesting of restricted stock units  (23)   
Payments on financing leases  (115)  (395)  (42)  (115)
Costs associated with Second Amended and Restated Credit Agreement     (149)
Net cash used in financing activities  (115)  (544)
Costs associated with refinancing  (136)   
Payments on long-term debt  (411)   
Borrowings on line of credit  22,767    
Repayments of line of credit  (23,029)   
Proceeds from private placement, net of cash issuance costs  18,426    
Net cash provided by (used in) financing activities  17,552   (115)
                
Net change in cash and cash equivalents  (2,496)  (1,048)  16,273   (2,496)
Cash and cash equivalents at beginning of period  5,237   6,797   2,341   5,237 
Cash and cash equivalents at end of period $2,741  $5,749  $18,614  $2,741 
        
Reconciliation of cash and restricted cash reported in the condensed consolidated balance sheets        
Cash and cash equivalents $18,175  $2,741 
Restricted cash  439    
Total cash and restricted cash reported in the condensed consolidated balance sheets $18,614   2,741 

See notes to unaudited condensed consolidated financial statements.

4

Notes to Unaudited Condensed Consolidated Financial Statements

(1)Business Description, Basis of Presentation and Summary of Significant Accounting Policies

Business Description and Basis of Presentation

The accompanying condensed consolidated financial statements include the accounts of Xtant Medical Holdings, Inc. (“Xtant”), a Delaware corporation, and its wholly owned subsidiaries, Xtant Medical, Inc. (“Xtant Medical”), a Delaware corporation, Bacterin International, Inc. (“Bacterin”), a Nevada corporation, and X-spine Systems, Inc. (“X-spine”), an Ohio corporation (Xtant, Xtant Medical, Bacterin, and X-spine are jointly referred to herein as the “Company” or sometimes “we,” “our,” or “us”). All intercompany balances and transactions have been eliminated in consolidation.

Xtant is a global medical technology company focused on the design, development, and commercialization of a comprehensive portfolio of orthobiologics and spinal implant systems to facilitate spinal fusion in complex spine, deformity, and degenerative procedures.

Since March 2020, the COVID-19 pandemic has caused business closures, severe travel restrictions and implementation of social distancing measures. At the onset of the COVID-19 pandemic and more recently as a result of the recent surge in cases and hospitalizations caused by the Delta variant, hospitals and other medical facilities have cancelled or deferred elective procedures, diverted resources to patients suffering from infections, and limited access for non-patients, including our direct and indirect sales representatives. Because of the COVID-19 pandemic,these circumstances, surgeons and their patients have, been, and may continue to be, required, or are choosing, to, defer procedures in which our products otherwise would be used, andused. In addition, many facilities that specialize in the procedures in which our products otherwise would beare used have experienced staffing shortages, temporary closures, and/or reduced operating hours. These circumstances have negatively impacted, and may continue to negatively impact, the number of elective procedures being conducted and the ability of our employees, independent sales representatives and distributors to effectively market and sell our products,products. This is particularly true during the third quarter of 2021, and most acutely starting in August, when spine and other surgery procedure volumes were negatively impacted in many of our key markets, due to cancellations and/or postponements of procedures as a result of the increased hospitalizations, restrictions on elective procedures and staffing shortages, which has hadnegatively impacted our third quarter 2021 revenues and will likelymay continue to have a material adverse effect onnegatively impact our revenues. If our revenues continue to decline in future periods and do not recover to pre-COVID-19 pandemic levels, we may be required to incur impairment charges to our long-lived assets and goodwill and write-down excess inventory, which would likely adversely affect our future operating results.

The accompanying condensed consolidated balance sheet as of December 31, 2019,2020, which has been derived from audited financial statements, and the unaudited interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America. They do not include all disclosures required by generally accepted accounting principles for annual consolidated financial statements, but in the opinion of management include all adjustments, consisting only of normal recurring items, necessary for a fair presentation.

Interim results are not necessarily indicative of results that may be achieved in the future for the full year ending December 31, 2020.2021.

These condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto, which are included in Xtant’s Annual Report on Form 10-K for the year ended December 31, 2019.2020. The accounting policies set forth in those annual consolidated financial statements are the same as the accounting policies utilized in the preparation of these condensed consolidated financial statements, except as modified for appropriate interim consolidated financial statement presentation.

Reclassifications

Certain prior year amounts have been reclassified to conform with current year presentation.

Recent Accounting PronouncementsPrivate Placement

In June 2016, the Financial Accounting Standards Board (“FASB”On February 24, 2021, we issued in a private placement (the “Private Placement”) issued Accounting Standards Update (“ASU”to a single healthcare-focused institutional accredited investor (the “Investor”) 2016-13, Financial Instruments–Credit Losses: Measurement8,888,890 shares of Credit Losses on Financial Instruments our common stock at a purchase price of $2.25 per share, and warrants to change the impairment model for most financial assets and certain other instruments. For tradepurchase up to 6,666,668 shares of our common stock (the “Investor Warrant”). We received net cash proceeds of approximately $18.4 million, after deducting fees and other receivables, heldestimated offering expenses, from the Private Placement.

5

The Investor Warrant, described in more detail in Note 10, “Warrants”, has an exercise price of $2.25 per share, subject to maturity debt securities, loans,customary anti-dilution, but not price protection, adjustments, is immediately exercisable and other instruments, entities are requiredexpires on the five-year anniversary of the date of issuance.

In connection with the Private Placement, we entered into a placement agent agreement with a placement agent (the “Placement Agent”) pursuant to usewhich the Placement Agent served as our exclusive placement agent in connection with the Private Placement (the “Placement Agent Agreement”). Pursuant to the Placement Agent Agreement, we agreed to pay the Placement Agent a new forward-looking “expected loss” model that generally will resultfee equal to a certain percentage of the aggregate gross proceeds from the Private Placement. In addition to the cash fee, we agreed to issue to the Placement Agent a warrant to purchase up to 5.0% of the shares sold to the Investor in the earlier recognitionPrivate Placement, or 444,444 shares of allowances for losses.our common stock (the “Placement Agent Warrant”). The Company adopted the guidance on January 1, 2020Placement Agent Warrant, described in more detail in Note 10, “Warrants”, has an exercise price of $2.8125 per share, subject to customary anti-dilution, but not price protection, adjustments, is immediately exercisable and recognized a cumulative effect adjustment of $47,000 to retained earnings and accounts receivable, net as a result of adoption. The Company has included the additional disclosures required by ASU 2016-13 in Note 3, “Receivables.”

Although there are several other new accounting pronouncements issued or proposed by the FASB, which the Company has adopted or will adopt, as applicable, the Company does not believe any of these accounting pronouncements has had or will have a material impactexpires on the Company’s consolidated financial position or operating results.five-year anniversary of the date of issuance.

Use of Estimates

The preparation of the condensed consolidated financial statements requires management of the Company to make a number of estimates and assumptions relating to the reported amount of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of revenue and expenses during the period. Significant estimates include the carrying amount of property and equipment, goodwill and intangible assets and liabilities, valuation allowances for trade receivables, inventory and deferred income tax assets and liabilities, current and long-term lease obligations and corresponding right-of-use asset evaluation of ability to continue as a going concern and estimates for the fair value of long-term debt, stock options and other equity awards upon which the Company determines stock-based compensation expense. Actual results could differ from those estimates.

Restricted Cash

Cash and cash equivalents classified as restricted cash on our condensed consolidated balance sheets are restricted as to withdrawal or use under the terms of certain credit agreements. The September 30, 2021 balance included lockbox deposits that are temporarily restricted due to timing at the period end. The lockbox deposits are applied against our line of credit the next business day.

Long-Lived Assets

The Company reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recovered. The Company looks primarily to estimated undiscounted future cash flows in its assessment of whether or not long-lived assets are recoverable. As a result of the revenue decline related to the COVID-19 pandemic, the Company evaluated whether the carrying values of the long-lived assets were recoverable. Based on these evaluations, the Company determined that the long-lived assets were still recoverable. NoNaN impairments of long-lived assets were recorded for the three and nine months ended September 30, 20202021 and 2019.2020.

Goodwill

Goodwill represents the excess of costs over fair value of assets of businesses acquired. Goodwill and intangible assets acquired in a purchase business combination and determined to have indefinite useful lives are not amortized. Instead, they are tested for impairment at least annually, and whenever events or circumstances indicate, that the carrying amount of the asset may not be recoverable. As a result of the COVID-19 pandemic and its impact on the Company’s projected cash flows, the Company evaluated goodwill for impairment at the end of the third quarter of 2020. NoNaN impairments of goodwill were recorded for the three months and nine months ended September 30, 20202021 and 2019.2020.

Net LossIncome (Loss) Per Share

Basic net income (loss) per share is computed by dividing net income (loss) by the weighted average number of shares of common stock outstanding. Shares issued during the period and shares reacquired during the period are weighted for the portion of the period that they were outstanding. Diluted net income (loss) per share is computed in a manner consistent with that of basic earnings per share while giving effect to all potentially dilutive shares of common stock outstanding during the period, which include the assumed exercise of stock options and warrants using the treasury stock method. Diluted net loss per share was the same as basic net loss per share for the three and nine months ended September 30, 20202021 and 2019,2020, as shares issuable upon the exercise of stock options and warrants were anti-dilutive as a result of the net losses incurred for those periods. DilutiveOur diluted earnings per share are not reported,is the same as basic earnings per share, as the effects of including 7,083,92214,138,224 and 3,313,9537,083,922 outstanding stock options, restricted stock units and warrants for the three and nine months ended September 30, 20202021 and 2019,2020, respectively, are anti-dilutive.

6

 

Fair Value of Financial Instruments

The carrying values of financial instruments, including trade accounts receivable, accounts payable, accrued liabilities, and long-term debt, approximate their fair values based on terms and related interest rates as of September 30, 20202021 and December 31, 2019.2020.

(2)Revenue

In the United States, we generate most of our revenue from independent commissioned sales agents. We consign our orthobiologics products to hospitals and consign or loan our spinal implant sets to the independent sales agents. The spinal implant sets typically contain the instruments, disposables, and spinal implants required to complete a surgery. Consigned sets are managed by the sales agent to service hospitals that are high volume users for multiple procedures.

We ship replacement inventory to independent sales agents to replace the consigned inventory used in surgeries. Loaned sets are returned to the Company’s distribution center, replenished, and made available to sales agents for the next surgical procedure.

For each surgical procedure, the sales agent reports use of the product by the hospital and, as soon as practicable thereafter, ensures that the hospital provides a purchase order to the Company. Upon receipt of the hospital purchase order, the Company invoices the hospital, and revenue is recognized in the proper period. Additionally, the Company sells product directly to domestic and international stocking resellers and private label resellers. Upon receipt and acceptance of a purchase order from a stocking reseller, the Company ships product and invoices the reseller. The Company recognizes revenue when control of the promised goods is transferred to the customer, in an amount that reflects the consideration we expectthe Company expects to collect in exchange for those goods or services. There is generally no customer acceptance or other condition that prevents the Company from recognizing revenue in accordance with the delivery terms for these sales transactions.

The Company operates in one reportable segment with ourits net revenue derived primarily from the sale of orthobiologics and spinal implant products across North America, Europe, Asia Pacific, and Latin America. Sales are reported net of returns. The following table presents revenues from these product lines for the three and nine months ended September 30, 20202021 and 20192020 (in thousands):

Summary of Revenues From Product Lines

  

Three

Months

Ended

  

Percentage

  

Three

Months

Ended

  

Percentage

 
  

September

30, 2021

  

of Total

Revenue

  

September

30, 2020

  

of Total

Revenue

 
Orthobiologics $10,795   78% $10,542   75%
Spinal implant  2,948   22%  3,438   25%
Other revenue  34   0%  36   0%
Total revenue $13,777   100% $14,016   100%

  

Nine

Months

Ended

  

Percentage

  

Nine

Months

Ended

  

Percentage

 
  

September

30, 2021

  

of Total

Revenue

  

September

30, 2020

  

of Total

Revenue

 
Orthobiologics $31,264   76% $28,613   73%
Spinal implant  9,929   24%  10,594   27%
Other revenue  100   0%  115   0%
Total revenue $41,293   100% $39,322   100%

7

 

  

Three Months

Ended

  Percentage of  

Three Months

Ended

  Percentage of 
  September 30, 2020  Total
Revenue
  September 30, 2019  Total
Revenue
 
Orthobiologics $10,542   75% $11,342   72%
Spinal implant  3,438   25%  4,349   28%
Other revenue  36   0%  30   0%
Total revenue $14,016   100% $15,721   100%

  

Nine Months

Ended

  Percentage of  

Nine Months

Ended

  Percentage of 
  September 30, 2020  Total
Revenue
  September 30, 2019  Total
Revenue
 
Orthobiologics $28,613   73% $34,374   72%
Spinal implant  10,594   27%  13,200   28%
Other revenue  115   0%  144   0%
Total revenue $39,322   100% $47,718   100%

(3)Receivables

3) Receivables

Concurrent with the adoption of ASU 2016-13, the

The Company’s allowance for doubtful accounts was expanded to include provision for current expected credit loss (“CECL”). The Company’s provision for CECL is determined based on historical collection experience adjusted for current economic conditions affecting collectability. Actual customer collections could differ from estimates. Account balances are charged to the allowance after all means of collection have been exhausted and the potential for recovery is considered remote. Provisions to the allowance for credit losses are charged to expense. Activity within the allowance for credit losses was as follows for the three months ended September 30, 2021 and 2020 (in thousands):

Schedule of Allowance for Credit Losses

Balance at January 1, 2020 $547 
Provision for expected credit losses  138 
Write-offs charged against allowance  (17)
Balance at March 31, 2020  668 
Provision for expected credit losses  66 
Write-offs charged against allowance  (6)
Balance at June 30, 2020  728 
Provision for expected credit losses  92 
Write-offs charged against allowance  (74)
Balance at September 30, 2020 $746 
  September 30, 2021  September 30, 2020 
Balance at January 1 $653  $547 
Provision for current expected credit losses  (63)  138 
Write-offs charged against allowance  (36)  (17)
Balance at March 31  554   668 
Provision for current expected credit losses  (81)  66 
Write-offs charged against allowance  (3)  (6)
Balance at June 30  470   728 
Provision for current expected credit losses  118   92 
Write-offs charged against allowance  (12)  (74)
Balance at September 30 $576  $746 

(4)Inventories

Inventories consist of the following (in thousands):

Schedule of Inventories

 September 30, 2020  December 31, 2019  September 30, 2021  December 31, 2020 
Raw materials $4,461  $3,805  $5,927  $3,757 
Work in process  2,332   1,603   674   1,733 
Finished goods  25,307   22,135   13,107   15,918 
Gross inventories  32,100   27,543 
Reserve for obsolescence  (11,429)  (11,442)
Total $20,671  $16,101  $19,708  $21,408 

(5)Property and Equipment, Net

Property and equipment, net are as follows (in thousands):

Schedule of Property and Equipment, Net

 September 30, 2020  December 31, 2019  September 30, 2021  December 31, 2020 
Equipment $4,682  $4,250  $5,195  $4,950 
Computer equipment  461   455   670   649 
Computer software  570   570   490   570 
Furniture and fixtures  133   124 
Leasehold improvements  3,987   3,980   4,022   3,987 
Vehicles  10   10 
Surgical instruments  11,147   10,897   11,647   11,291 
Total cost  20,990   20,286   22,024   21,447 
Less: accumulated depreciation  (16,868)  (15,591)  (17,053)  (17,100)
Property and equipment, net $4,122  $4,695  $4,971  $4,347 

The Company leases certainDepreciation expense related to property and equipment, including property under finance leases. For financial reporting purposes, minimum lease payments relating toleases, for the assets have been capitalized. As ofthree months ended September 30, 2021 and 2020 was $0.3 million and $0.5 million, respectively, and $1 million and $1.6 million for the Company has recorded $0.5 million of gross assets in equipmentnine months ended September 30, 2021 and $0.4 million of accumulated depreciation for assets subject to finance leases.2020, respectively.

8

(6)Intangible Assets

The following table sets forth information regarding intangible assets (in thousands):

Schedule of Intangible Assets

 September 30, 2020  December 31, 2019  September 30, 2021  December 31, 2020 
Patents $847  $847  $847  $847 
Accumulated amortization  (376)  (332)  (433)  (390)
Intangible assets, net $471  $515  $414  $457 

(7)Accrued Liabilities

Accrued liabilities consist of the following (in thousands):

Schedule of Accrued Liabilities

 September 30, 2020 December 31, 2019  September 30, 2021  December 31, 2020��
Wages/commissions payable $3,788  $3,902 
Cash compensation/commissions payable $2,991  $4,057 
Other accrued liabilities  2,255  2,730   1,088   1,405 
Accrued liabilities $6,043 $6,632  $4,079  $5,462 

(8)Debt

On March 29, 2019, we entered intoThe Company had a Second Amended and Restated Credit Agreement (the “Second Amended and Restated Credit Agreement”)credit facility with OrbiMed Royalty Opportunities II, LP (“Royalty Opportunities”) and ROS Acquisition Offshore LP (“ROS” and together with Royalty Opportunities the “Lenders”), which amended and restated the prior credit agreement with the Lenders (the “Prior Credit Agreement”). , which was scheduled to mature on December 31, 2021, but was extinguished prior to maturity and replaced by the credit agreements with MidCap Financial Trust described below.

On May 6, 2020, we2021, the Company, as guarantor, and its subsidiaries, as borrowers (collectively, the “Borrowers”), entered into a First AmendmentCredit, Security and Guaranty Agreement (Term Loan) (the “Term Credit Agreement”) and Credit, Security and Guaranty Agreement (Revolving Loan) (the “Revolving Credit Agreement,” and, together with the Term Credit Agreement, the “Credit Agreements”) with MidCap Financial Trust, in its capacity as agent (“MidCap”) .

The Term Credit Agreement provides for a secured term loan facility (the “Term Facility”) in an aggregate principal amount of $12.0 million (the “Term Loan Commitment”), which was funded to the Second AmendedBorrowers immediately, and Restatedan additional $5.0 million tranche available solely at the discretion of MidCap and the lenders, for the purposes agreed to between the Company, the Borrowers and the lenders in advance of the making of loans under such additional tranche. The Revolving Credit Agreement provides for a secured revolving credit facility (the “First Amendment”)“Revolving Facility,” and, together with the Lenders,Term Facility, the “Facilities”) under which the Borrowers may borrow up to $8.0 million (such amount, the “Revolving Loan Commitment”) at any one time, the availability of which is determined based on a borrowing base equal to percentages of certain accounts receivable and inventory of the Borrowers in accordance with a formula set forth in the Revolving Credit Agreement. All borrowings under the Revolving Facility are subject to the satisfaction of customary conditions, including the absence of default, the accuracy of representations and warranties in all material respects and the delivery of an updated borrowing base certificate.

The Facilities have a maturity date of May 1, 2026. The proceeds of the Term Facility were used to pay transaction fees in connection with the Facilities and to pay in full all outstanding indebtedness and accrued interest under the Prior Credit Agreement. The proceeds of the Revolving Facility were used to pay transaction fees in connection with the Facilities, to pay in full all outstanding indebtedness and accrued interest under the Prior Credit Agreement, and for working capital and general corporate purposes. As a result of the refinancing, we recorded a gain on extinguishment totalling $0.8 million. The gain represents the difference between the carrying value of our outstanding loans under the Prior Credit Agreement prior to the extinguishment and $15.6 million, the reacquisition price. Because of the related party affiliation between the Company and Royalty Opportunities, this debt extinguishment resulted in an increase in additional paid-in capital rather than flowing through our consolidated statements of operations as a gain on extinguishment.

9

The loans and other obligations pursuant to the Credit Agreements bear interest at a per annum rate equal to the sum of the LIBOR rate, as such term is defined in the Credit Agreements, plus the applicable margin of 7.00% in the case of the Term Credit Agreement, and 4.50% in the case of the Revolving Credit Agreement, subject in each case to a LIBOR floor of 1.00%. The effective rate of the Term Facility was 8.83% as of September 30, 2021. In addition to paying interest on the outstanding loans under the Facilities, the Borrowers are also required to pay an unused line fee equal to 0.50% per annum in respect of unutilized commitments under the Revolving Facility, a fee for failure to maintain a minimum balance under the Revolving Facility, a collateral management fee under the Revolving Facility equal to 0.50% of the amount outstanding under the Revolving Facility, an origination fee equal to 0.50% of the Revolving Loan Commitment and 0.50% of the Term Loan Commitment, and if activated, of any additional term loan tranche, and certain other customary fees related to the Agent’s administration of the Facilities.

The Credit Agreements contain affirmative and negative covenants customarily applicable to senior secured credit facilities, including covenants that, among other things, provided that:

No interest will accrue on the outstanding loans under the Second Amended and Restated Credit Agreement (the “Loans”) from and after March 31, 2020 until September 30, 2020;
Beginning October 1, 2020 through the maturity date of the Second Amended and Restated Credit Agreement, interest payable in cash will accrue on the Loans under the Second Amended and Restated Credit Agreement at a rate per annum equal to the sum of (i) 10.00% plus (ii) the higher of (x) the LIBO Rate (as such term is defined in the Second Amended and Restated Credit Agreement) and (y) 2.3125%;
The maturity date of the Loans is December 31, 2021;
The Revenue Base (as such term is defined in the Second Amended and Restated Credit Agreement) financial covenant was revised through December 31, 2021; and
The key person event default provision was revised to refer specifically to Sean Browne in lieu of a former executive.

On May 6, 2020, we issued warrants to purchase an aggregate of 2.4 million shares of our common stock tolimit or restrict the Lenders, with an exercise price of $0.01 per share and an expiration date of May 6, 2030 (collectively, the “2020 Warrants”). The issuanceability of the 2020 Warrants wasBorrowers, subject to negotiated exceptions, to incur additional indebtedness and additional liens on their assets, engage in mergers or acquisitions or dispose of assets, pay dividends or make other distributions, voluntarily prepay other indebtedness, enter into transactions with affiliated persons, make investments, and change the nature of their businesses. In addition, the Credit Agreements require the Borrowers and the Company to maintain net product revenue at or above minimum levels and to maintain a condition tominimum adjusted EBITDA and a minimum liquidity, in each case at levels specified in the effectiveness of the First Amendment. The First Amendment was accounted for as a debt modification whereby the recorded debt balance was discounted for the fair value of the 2020 Warrants issued and interest expense is accrued through the maturity date of the Loans at the post-amendment effective interest rate of 10.02%.

Credit Agreements. As of September 30, 2020,2021, we were in compliance with all covenants under the Company had availability for additional delayed draw loan advances of $2.2 million, subject to Lenders’ discretion, and in addition, as of such date, the Company could request additional term loans from the Lenders in an aggregate amount up to $10.0 million, subject to Lenders’ discretion.Credit Agreements.

Long-term debt consists of the following (in thousands):

Schedule of Long-term Debt

  September 30, 2020  December 31, 2019 
Amounts due under the Second Amended and Restated Credit Agreement $76,886  $72,657 
PIK interest payable related to Second Amended and Restated Credit Agreement     3,280 
Plus: 2% exit fee  820   399 
Gross long-term debt  77,706   76,336 
Premium related to First Amendment  1,974    
Less: total debt issuance costs on Credit Agreements  (53)  (92)
Long-term debt, plus premium and less issuance costs $79,627  $76,244 
  September 30, 2021  December 31, 2020 
Amounts due under the Term Facility $12,000  $ 
Amounts due under the Second Amended and Restated Credit Agreement     15,556 
Premium related to Second Amendment     1,241 
Less: unamortized debt issuance costs  (322)   
Less: current maturities     (16,797)
Long-term debt $11,678  $ 

Subsequent to the end of the quarter ended September 30, 2020, in connection with the restructuring transactions described in Note 16, “Subsequent Events,” on October 1, 2020, we entered into a Second Amendment to the Second Amended and Restated Credit Agreement (the “Second Amendment”) with the Lenders, which among other things, provided for:

Extinguishment by the Lenders of approximately $61.9 million of principal and paid-in-kind interest outstanding on the Loans in exchange for approximately 57.8 million shares of our common stock and the addition of a principal amount equal to prepayment fees associated with the Loans not paid in cash or exchanged for shares of our common stock;
Exchange of approximately $0.9 million of prepayment fees associated with the Loans for approximately 0.9 million shares of our common stock (the “Prepayment Fee Shares”);
Elimination of the availability of additional draw loan advances and reduction of available additional term loans to $5.0 million;
Accrual of interest payable in cash for the remaining term of the Second Amended and Restated Credit Agreement at a rate per annum equal to the sum of (i) 7.00% plus (ii) the higher of (x) the LIBO Rate (as such term is defined in the Second Amended and Restated Credit Agreement) and (y) 1.00%; and
Elimination of certain financial covenants.

The Lenders, which were the sole holders of the Company’s outstanding debt as of September 30, 2020, collectively owned approximately 70% of the Company’s outstanding common stock, and beneficially owned, with their warrants, approximately 78% of the Company’s common stock as of such date. As a result of the execution of the Second Amendment and the completion of the restructuring transactions described in Note 16, “Subsequent Events,” Royalty Opportunities is now the sole holder of our outstanding debt under our credit facility and the Lenders currently own, in the aggregate, approximately 94.5% of our outstanding common stock and all other existing stockholders of the Company own approximately 5.5% of our outstanding common stock.

(9)Stock-Based Compensation

Stock option activity, including options granted under the Xtant Medical Holdings, Inc. 2018 Equity Incentive Plan, as amended (the “2018 Plan”), and the Amended and Restated Xtant Medical Equity Incentive Plan and options granted to new hires to purchase shares of our common stock outside of any stockholder-approved plan, was as follows for the nine months ended:ended September 30, 2021 and 2020:

Schedule of Share-based Compensation, Stock Options, Activity

  2021  2020 
  Shares  

Weighted

Average

Exercise Price Per Share

  

Weighted

Average Fair

Value at Grant

Date Per

Share

  Shares  

Weighted

Average

Exercise Price

Per Share

  

Weighted

Average Fair

Value at Grant

Date Per Share

 
Outstanding at January 1  2,190,892  $2.25  $1.65   602,966  $6.07  $3.99 
Granted  1,012,083  $1.27  $1.07   239,884  $1.13  $0.90 
Cancelled or expired  (269) $314.19  $153.41   (120,738) $6.42  $4.05 
Outstanding at September 30  3,202,706  $1.92  $1.45   722,112  $4.37  $2.96 
Exercisable at September 30  210,028  $9.02  $5.69   49,979  $33.70  $19.67 

10

 

  2020  2019 
  Shares  

Weighted

Average

Exercise Price Per Share

  

Weighted

Average Fair

Value at Grant

Date Per

Share

  Shares  

Weighted

Average

Exercise Price

Per Share

  

Weighted

Average Fair

Value at Grant

Date Per Share

 
Outstanding at January 1  602,966  $6.07  $3.99   496,958  $9.90  $6.62 
Granted  239,884  $1.13  $0.90   100,000  $2.24  $1.95 
Cancelled or expired  (120,738) $6.42  $4.05   (448,053) $4.64  $3.69 
Outstanding at September 30  722,112  $4.37  $2.96   148,905  $9.12  $6.53 
Exercisable at September 30  49,979  $33.70  $19.67   18,135  $52.04  $33.67 

Restricted stock unit activity for awards granted under the 2018 Plan was as follows for the nine months ended:ended September 30, 2021 and 2020:

Schedule of Restricted Stock Activity

 

2020

  2019  2021  2020 
 Shares  

Weighted

Average Fair

Value at Grant

Date Per

Share

  Shares  

Weighted

Average Fair

Value at Grant

Date Per Share

  Shares  

Weighted

Average
Fair

Value at
Grant

Date Per

Share

  Shares  

Weighted

Average
Fair

Value at
Grant

Date Per
Share

 
Outstanding at January 1  499,914  $2.93   40,000  $6.20   2,503,698  $1.54   499,914  $2.93 
Granted  679,803  $1.36   89,204  $2.74   1,249,002  $1.27   679,803  $1.36 
Vested  (79,069) $2.37   -  $-   (349,572) $1.92   (79,069) $2.37 
Outstanding at September 30  1,100,648  $2.00   129,204  $3.81   3,403,128  $1.40   1,100,648  $2.00 

(10)Warrants

2020 Warrants

As noted in Note 8,1,DebtBusiness Description, Basis of Presentation and Summary of Significant Accounting Policies,” on May 6, 2020,February 22, 2021, the Company issued the 2020Investor Warrants and Placement Agent Warrants. The fair value of the 2020 Warrants upon issuance was determined to be $1.9 million. The 2020Investor and Placement Agent Warrants meet all the requirements to be classified as equity awards in accordance with Accounting Standards Codification (“ASC”) No. 815-40. The number of shares of Company common stock issuable upon exercise of the 2020Investor Warrants and Placement Agent Warrants is subject to standard and customary anti-dilution provisions for stock splits, stock dividends, or similar transactions.

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2019 In addition, the Investor Warrants

On April 1, 2019, include a buy-out right whereby the holders of such warrants may put the warrants back to the Company issuedor its successor in the event of a purchase, tender or exchange offer accepted by 50% or more of the Company’s holders of common stock and not approved by the Company’s board of directors. The buy-out amount is equal to the Black-Scholes value of the warrants on the date the triggering transaction is consummated based on certain inputs as defined in the Investor Warrant agreement. The consideration to purchase an aggregatebe paid if the buy-out provision is triggered shall be in the same type or form of 1.2 million sharesconsideration that is being offered and paid to the holders of Company common stock in connection with the triggering transaction.

While the Investor Warrants are classified as a component of equity, we were required to allocate the Lenders with an exercise price of $0.01 per share and an expiration date of April 1, 2029. The issuanceproceeds of the 2019Private Placement between the shares of common stock and Investor Warrants wasissued based on their relative fair values. We utilized a conditionlattice valuation model to determine the effectivenessfair value of the Second Amended and Restated Credit Agreement.Investor Warrants. The fair value of the 2019Placement Agent Warrants upon issuanceissued in connection with the Private Placement was determined to be $9 thousand. The 2019 Warrants meet all the requirements to be classified as equity awards in accordance with ASC No. 815-40. The number of shares of Company common stock issuable upon exercise of the 2019 Warrants is subject to standard and customary anti-dilution provisions for stock splits, stock dividends, or similar transactions.

  Common Stock Warrants  Weighted Average Exercise Price 
Outstanding at January 1, 2020  2,908,874  $4.16 
Issued  2,400,000   0.01 
Expired  (47,712)  85.44 
Outstanding at September 30, 2020  5,261,162  $1.53 

The estimated fair value of warrants issued was derived using a valuation model withBlack Scholes model. Significant assumptions in both models included contractual term (5 years) and the following weighted-average assumptions:estimated volatility factor based on a weighted average of comparable published betas of peer companies (61%).

  Nine Months Ended September 30, 
  2020  2019 
Risk free interest rate  2.0%  1.7%
Expected term in years  10.0   3.0 
Volatility  105.0%  85.0%
Dividend yield  0.0%  0.0%

Our warrant activity during the nine months ended September 30, 2021 was as follows:

Schedule of Warrant Activity

  Common Stock Warrants  Weighted Average Exercise Price 
Outstanding at January 1, 2021  421,278  $10.80 
Issued  7,111,112   2.29 
Outstanding at September 30, 2021  7,532,390  $2.76 

(11)Commitments and Contingencies

Operating Leases

We lease three office facilities as of September 30, 20202021 in Belgrade, Montana under non-cancelable operating lease agreements with expiration dates between 2023 and 2025. We have the option to extend certain leases to five or ten-year term(s), and we have the right of first refusal on any sale.

Present Value of Long-term Leases

(in thousands): September 30, 2020 
Right-of-use assets, net $1,795 
     
Current portion of lease liability  415 
Lease liability, less current portion  1,412 
Total lease liability $1,827 

As of September 30, 2020,2021, the weighted-average remaining lease term was 4.1 years. The Company’s lease agreements do not provide a readily determinable implicit rate nor is it available to the Company from its lessors. Instead, as3.2 years.

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Present Value of September 30, 2020, the Company estimates the weighted-average discount rate for its operating leases to be 5.2%Long-term Leases

Schedule of present value based on the incremental borrowing rate.Lease Liability

(in thousands): September 30, 2021 
Right-of-use assets, net $1,369 
     
Current portion of lease liability $451 
Lease liability, less current portion  961 
Total lease liability $1,412 

Future minimum payments for the next five years and thereafter as of September 30, 20202021 under these long-term operating leases are as follows (in thousands):

Schedule of Future Minimum Rental Payments for Operating Leases

Remainder of 2020 $126 
2021  507 
  2021 
Remainder of 2021 $127 
2022  521   521 
2023  489   489 
2024  224   224 
Thereafter  179 
2025  179 
Total future minimum lease payments  2,046   1,540 
Less amount representing interest  (219)  (128)
Present value of obligations under operating leases  1,827   1,412 
Less current portion  (415)  (451)
Long-term operating lease obligations $1,412  $961 

Rent expense was $0.1$0.1 million for the three months ended September 30, 2021 and 2020 and 2019 and $0.4$0.4 million for the nine months ended September 30, 20202021 and 2019.2020. We have no contingent rent agreements.

Financing Leases

Future minimum payments under finance leases are as follows as of September 30, 2020 (in thousands):

Remainder of 2020 $59 
Less amount representing interest  - 
Present value of obligations under financing leases $59 

Litigation

On December 13, 2018,In November 2020, we received a complaint was filed by RSB Spine, LLC against Xtant Medical Holdings, Inc., which claimedletter from a third party’s legal counsel alleging that some of our hardware products including the Irix-A Lumbar Integrated Fusion Systemallegedly infringe an expired patent and the Irix-C Cervical Integrated Fusion System, infringe certain of RSB Spine’s patents. On February 28, 2020,offering to discuss settlement terms. Without admitting any liability, in July 2021, we entered into a confidential settlement agreement and release that included, among other things, a full release of all asserted patent license agreement with RSB Spine pursuantclaims from the third party and otherwise settled the dispute in exchange for a one-time lump sum payment of $550,000, which was recorded as a special charge in the second quarter 2021 to which we agreed to make an undisclosed settlement payment to RSB Spinegeneral and pay royalties on future sales of the two products through the expiration of the asserted patents. The settlement payment was included in accrued expenses as of December 31, 2019.administrative expense.

In addition, we are subject to potential liabilities under government regulations and various claims and legal actions that are pending or may be asserted from time to time.

These matters arise in the ordinary course and conduct of our business and may include, for example, commercial, product liability, intellectual property, and employment matters. We intend to continue to defend the Company vigorously in such matters and, when warranted, take legal action against others. Furthermore, we regularly assess contingencies to determine the degree of probability and range of possible loss for potential accrual in our financial statements. An estimated loss contingency is accrued in our financial statements if it is probable that a liability has been incurred and the amount of the loss can be reasonably estimated. Based on our assessment, we have adequately accrued an amount for contingent liabilities currently in existence. We do not accrue amounts for liabilities that we do not believe are probable or that we consider immaterial to our overall financial position. Litigation is inherently unpredictable, and unfavorable resolutions could occur. As a result, assessing contingencies is highly subjective and requires judgment about future events. The amount of ultimate loss may exceed the Company’s current accruals, and it is possible that its cash flows or results of operations could be materially affected in any particular period by the unfavorable resolution of one or more of these contingencies.

Indemnifications

Our indemnification arrangements generally include limited warranties and certain provisions for indemnifying customers against liabilities if our products or services infringe a third-party’s intellectual property rights. To date, we have not incurred any material costs as a result of such warranties or indemnification provisions and have not accrued any liabilities related to such obligations in the accompanying condensed consolidated financial statements.

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We have also agreed to indemnify our directors and executive officers for costs associated with any fees, expenses, judgments, fines, and settlement amounts incurred by any of these persons in any action or proceeding to which any of those persons is, or is threatened to be, made a party by reason of the person’s service as a director or officer, including any action by us, arising out of that person’s services as our director or officer or that person’s services provided to any other company or enterprise at our request.

(12)Income Taxes

In evaluating the realizability of the net deferred tax assets, we take into account a number of factors, primarily relating to the ability to generate taxable income. Where it is determined that it is likely that we will be unable to realize deferred tax assets, a valuation allowance is established against the applicable portion of the deferred tax asset. Because it cannot be accurately determined when or if we will become profitable, a valuation allowance was provided against the entire deferred income tax asset balance.

The Company did not recognize any interest or penalties related to income taxes for the three and nine months ended September 30, 20202021 and 2019.2020.

(13)Supplemental Disclosure of Cash Flow Information

Supplemental cash flow information is as follows (in thousands):

Schedule of Supplemental Cash Flow Information

  Nine Months Ended 
  September, 
  2020  2019 
Supplemental disclosure of cash flow information        
Cash paid during the period for:        
Interest $13  $47 
Non-cash activities:        
ASU 2016-13 cumulative effect adjustment $47  $ 
Recognition of 2020 Warrants $1,862  $ 
Lease liability from right-of-use assets $  $2,296 
Extinguishment of the Company’s Prior Credit Agreement (including debt issuance costs) $  $79,624 
Recognition of Second Amended and Restated Credit Agreement $  $72,657 
Write-off of Prior Credit Agreement debt issuance costs and existing ROS fees $  $307 
Recognition of 2019 Warrants $  $9 
  2021  2020 
  Nine Months Ended 
  September 30, 
  2021  2020 
Supplemental disclosure of cash flow information      
Cash paid during the period for:      
Interest $485  $13 
Non-cash activities:        
Gain on extinguishment of Second A&R Credit Agreement $786  $ 
Extinguishment of Second A&R Credit Agreement financed by line of credit $3,755  $ 
Prepaid debt issuance costs $75  $ 
Fixed assets acquired under finance lease $163  $ 
Warrants issued in connection with the Private Placement to placement agents $351  $ 
ASU 2016-13 cumulative effect adjustment $  $47 
Recognition or warrants issued in connect with debt modification $  $1,862 

(14)Related Party Transactions

Royalty Opportunities, and ROS, which were the sole holders of the Company’s outstanding debt as of September 30, 2020, collectively ownedowns approximately 70%20% of the Company’s outstanding common stock, and beneficially owned, with their warrants, approximately 78% of the Company’s common stock as of such date. As a result of the completion of the restructuring transactions described in Note 16, “Subsequent Events,” Royalty Opportunities and ROS currently own, in the aggregate, approximately 94.5% of the outstanding common stock and all other existing stockholders of the Company own approximately 5.5% of the outstanding common stock, and Royalty Opportunities is currentlywas the sole holder of our outstanding debt.

long-term debt and a party to the Second Amended and Restated Credit Agreement, which was terminated in connection with our debt refinancing described under Note 8, “Debt”. In addition, as described in more detail under Note 1, “Business Description and Summary of Significant Accounting Policies” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 and Note 16, “Subsequent Events,”2020, we are party to an Investor Rights Agreement, and Registration Rights Agreements and certain other agreements with Royalty Opportunities and ROS.ROS Acquisition Offshore LP, which are funds affiliated with OrbiMed Advisors LLC (“OrbiMed”). OrbiMed beneficially owns 84% of the Company’s common stock.

On January 22, 2020, the Company amended its Sublease Agreement with Cardialen, Inc., reducing monthly rent to $1,350 per month. Because Jeffrey Peters is both a member of our Board and the Chief Executive Officer, President, and a Director of Cardialen, this transaction qualifies as a related party transaction.

All related party transactions are reviewed and approved by the Audit Committee or the disinterested members of the full Board.board of directors.

(15) Segment and Geographic Information

The Company’s management reviews financial results and manages the business on an aggregate basis. Therefore, financial results are reported in a single operating segment: the development, manufacture, and marketing of orthopedic medical products and devices.

The Company attributes revenues to geographic areas based on the location of the customer. Approximately 98%99% and 96%98% of sales were in the United States for the three months ended September 30, 20202021 and 2019,2020, respectively, and 98%99% and 96%98% for the nine months ended September 30, 20202021 and 2019,2020, respectively. Total revenue by major geographic area is as follows (in thousands):

Schedule of Revenues by Geographic Region

  

Three Months Ended
September 30,

 
  2021  2020 
United States $13,629  $13,773 
Rest of world  148   243 
Total revenue $13,777  $14,016 

  Nine Months Ended
September 30,
 
  2021  2020 
United States $40,813  $38,340 
Rest of world  480   982 
Total revenue $41,293  $39,322 

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Three Months Ended

September 30,

 
  2020  2019 
United States $13,773  $15,097 
Rest of world  243   624 
Total revenue $14,016  $15,721 

  

Nine Months Ended

September 30,

 
  2020  2019 
United States $38,340  $45,781 
Rest of world  982   1,937 
Total revenue $39,322  $47,718 

(16) Subsequent Events

Debt Restructuring

On August 7, 2020, we entered into a Restructuring and Exchange Agreement (the “Restructuring Agreement”) with Royalty Opportunities and ROS, pursuant to which the parties thereto agreed, subject to the terms and conditions set forth therein, to take certain actions as set forth therein and as described below (collectively, the “Restructuring Transactions”) in furtherance of a restructuring of the Company’s outstanding indebtedness under Second Amended and Restated Credit Agreement. The Restructuring Transactions included, among others:

an amendment to the Company’s Amended and Restated Certificate of Incorporation, as amended, to increase the number of authorized shares of common stock, par value $0.000001 per share, of the Company from 75 million to 300 million (the “Charter Amendment”), which occurred on October 1, 2020;
the exchange by the Company of shares of common stock for approximately $40.8 million of the aggregate outstanding principal amount of the Loans (as defined in the Second Amended and Restated Credit Agreement) outstanding under the Second Amended and Restated Credit Agreement, as well as, without duplication, approximately $21.1 million of the outstanding amount of PIK Interest (as defined in the Second Amended and Restated Credit Agreement) (such loans and PIK Interest, the “Exchanging Loans”), plus all other accrued and unpaid interest on the Exchanging Loans outstanding as of the closing date, at an exchange price of $1.07 per share, representing the average closing price of the common stock over the 10 trading days immediately prior to the parties entering into the Restructuring Agreement, and resulting in the issuance of approximately 57.8 million shares of common stock (the “Share Issuance”), which occurred on October 1, 2020;
the execution of the Second Amendment, as described in more detail above under Note 8, “Debt”; which occurred on October 1, 2020; and
the launch by the Company of a rights offering to allow stockholders of the Company to purchase up to an aggregate of $15 million of common stock at the same price per share as the $1.07 per share exchange price used to exchange the Exchanging Loans into common stock as part of the Share Issuance (the “Rights Offering”), the details of which the Company announced publicly on October 22, 2020 and are described in more detail below.

As a result of the completion of these Restructuring Transactions, Royalty Opportunities and ROS own, in the aggregate, approximately 94.5% of the outstanding common stock and all other existing stockholders of the Company own approximately 5.5% of the outstanding common stock. Following completion of these Restructuring Transactions the remaining principal balance of our outstanding debt totals $15.6 million.

Also on October 1, 2020, in connection with and as a condition to the closing of the Restructuring Transactions, the Company entered into a Registration Rights Agreement with the Lenders, which requires the Company to, among other things, file with the SEC a shelf registration statement covering the resale, from time to time, of the common stock issuable upon exchange of the Exchanging Loans and the Prepayment Fee Shares no later than the 90th day after the closing date and use its best efforts to cause the shelf registration statement to become effective under the Securities Act of 1933, as amended, no later than the 180th day after the closing date of the Restructuring Transactions.

Rights Offering

Pursuant to the terms of the Restructuring Agreement, on October 22, 2020, we announced that the Board of Directors has set November 5, 2020 as the record date for the Rights Offering. Subject to the registration statement on Form S-1 relating to the Rights Offering becoming effective on or about November 3, 2020, we intend to distribute to holders of our common stock, at no charge, 0.194539 non-transferable subscription rights for each share of common stock held on the record date. Each whole subscription right will entitle the holder to purchase one share of our common stock for $1.07 in cash. No fractional shares will be issued in the Rights Offering. Any fractional shares of common stock created by the exercise of rights will be rounded down to the nearest whole share. In addition, holders as of the record date will have an over-subscription privilege, pursuant to which they may be able to purchase additional shares at the subscription price, to the extent that not all subscription rights are exercised, subject to certain limitations. We expect that subscription materials for the Rights Offering will be mailed on or about November 6, 2020 to holders of our common stock as of the record date, and that the Rights Offering will close as soon as practicable after the anticipated December 4, 2020 expiration date. The Board of Directors may extend the rights offering for additional periods of time in its sole discretion.

Xtant Medical Holdings, Inc. Amended and Restated Equity Incentive Plan

On October 27, 2020, at the 2020 Annual Meeting of Stockholders of the Company (the “2020 Annual Meeting”), the Company’s stockholders approved and adopted, upon recommendation of the Board of Directors, an amended and restated version of the 2018 Plan, which incorporates certain amendments, including an amendment to increase the number of shares of our common stock available for issuance under the 2018 Plan by an additional 5,550,308 shares and a new limit on overall non-employee director compensation of $400,000 per year or $600,000 in the case of a non-employee chairman, lead independent director, or non-employee director in the first year of service on the Board (the “Amended 2018 Plan”).

Equity Grants to President and Chief Executive Officer

On October 27, 2020, immediately after completion of the 2020 Annual Meeting and adoption of the Amended 2018 Plan, the Board of Directors granted, effective as of November 15, 2020, the Company’s President and Chief Executive Officer, an option to purchase 1,468,859 shares of our common stock and a restricted stock unit award covering 1,468,859 shares of our common stock pursuant to the terms of his employment agreement with the Company which entitles him to receive an additional equity grant, 50% in the form of stock options and 50% in the form of restricted stock units, in the event OrbiMed Advisors LLC (including its affiliates) converted any of its remaining outstanding indebtedness of the Company into equity of the Company prior to October 7, 2024.

ITEM 2.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

This Management’s Discussion and Analysis provides material historical and prospective disclosures intended to enable investors and other users to assess our financial condition and results of operations. The following discussion should be read in conjunction with our condensed consolidated financial statements and accompanying notes included in this Quarterly Report on Form 10-Q and the audited consolidated financial statements and accompanying notes thereto and Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019.2020. In addition to historical financial information, the following discussion and analysis contains forward-looking statements that involve risks, uncertainties, and assumptions. Some of the numbers included herein have been rounded for the convenience of presentation. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of many factors, including those discussed above in “Cautionary Statement Regarding Forward-Looking Statements” and elsewhere in this Form 10-Q.

Business Overview

We develop, manufacture and market regenerative medicine products and medical devices for domestic and international markets. Our products serve the specialized needs of orthopedic and neurological surgeons, including orthobiologics for the promotion of bone healing, implants and instrumentation for the treatment of spinal disease. We promote our products in the United States largely through independent distributors and stocking agents, augmentedsupported by direct employees.

Recent Debt RestructuringWe have an extensive sales channel of independent commissioned agents and stocking distributors in the United States representing some or all of our products. We also maintain a national accounts program to enable our agents to gain access to integrated delivery network hospitals (“IDNs”) and through group purchasing organizations (“GPOs”). We have biologics contracts with major GPOs, as well as extensive access to IDNs across the United States for both biologics and spine hardware systems. While our focus is the United States market, we promote and sell our products internationally through stocking distribution partners in Canada, Mexico, South America, Australia, and certain Pacific region countries.

On August 7, 2020,During 2021, we enteredhave focused primarily on four key growth initiatives: (1) introduce new products; (2) expand our distribution network; (3) penetrate adjacent markets; and (4) leverage our growth platform with technology and strategic acquisitions. This year we have launched three new products, with a fourth product, a bone marrow aspirate concentrate offering, set to be introduced in November 2021. We have met our goal to expand our distribution network for 2021 by bringing on over forty new agents through September 2021. We have added new sales personnel to leverage certain adjacent non-spine markets, such as the foot and ankle, cranio-maxillofacial, oncology, joint reconstruction and trauma markets. We began making progress towards this goal during the three months ended September 30, 2021 when we expanded our private label and original equipment manufacturer sales into a Restructuring and Exchange Agreement with OrbiMed Royalty Opportunities II, LP and ROS Acquisition Offshore LP, pursuantthese adjacent markets. Finally, one of our key growth initiatives is to whichadd depth to our product offering through targeted strategic acquisitions. While the parties thereto agreed, subject to the terms and conditions set forth therein, to take certain actions as set forth therein and as described below in furtherance of a restructuring of the Company’s outstanding indebtedness under Second Amended and Restated Credit Agreement.

The Restructuring Transactions include, among others:

an amendment to the Company’s Amended and Restated Certificate of Incorporation, as amended, to increase the number of authorized shares of common stock, par value $0.000001 per share, of the Company from 75 million to 300 million, which became effective on October 1, 2020;
the exchange by the Company of shares of our common stock for approximately $40.8 million of the aggregate outstanding principal amount of the Loans (as defined in the Second Amended and Restated Credit Agreement) outstanding under the Second Amended and Restated Credit Agreement, as well as, without duplication, approximately $21.1 million of the outstanding amount of PIK Interest (as defined in the Second Amended and Restated Credit Agreement), plus all other accrued and unpaid interest on the Exchanging Loans outstanding as of the closing date, at an exchange price of $1.07 per share, representing the average closing price of the common stock over the 10 trading days immediately prior to the parties entering into the Restructuring Agreement, and resulting in the issuance of approximately 57.8 million shares of common stock, which occurred on October 1, 2020;
the execution of an amendment to the Second Amended and Restated Credit Agreement by the parties thereto to change certain provisions therein which occurred on October 1, 2020 and is described in more detail below; and
the launch by the Company of a rights offering to allow stockholders of the Company to purchase up to an aggregate of $15 million of common stock at the same price per share as the $1.07 per share exchange price used to exchange the Exchanging Loans into common stock as part of the Share Issuance, the details of which the Company announced publicly on October 22, 2020 and are described in more detail below.

As a result of the completionintent of these Restructuring Transactions, Royalty Opportunities and ROS own,four key growth initiatives is to increase our future revenues, no assurance can be provided that we will be successful in the aggregate, approximately 94.5% of the outstanding common stock and all other existing stockholders of the Company own approximately 5.5% of the outstanding common stock. Following completion ofimplementing these Restructuring Transactions the remaining principal balance ofgrowth initiatives or increasing our outstanding debt totals $15.6 million.future revenues.

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Also on October 1, 2020, in connection with and as a condition to the Closing of the Restructuring Transactions, the Company entered into a Registration Rights Agreement with the Lenders, which requires the Company to, among other things, file with the SEC a shelf registration statement covering the resale, from time to time, of the common stock issuable upon exchange of the Exchanging Loans and the Prepayment Fee Shares no later than the 90th day after the closing date and use its best efforts to cause the shelf registration statement to become effective under the Securities Act, no later than the 180th day after the closing date.

As a result of the completion of the debt restructuring, on October 5, 2020 we received notification from NYSE Regulation that the Company had regained compliance with all of the continued listing standards of the NYSE American, including in particular the requirement under NYSE American Company Guide Section 1003(a)(iii) that requires a listed issuer to maintain stockholders’ equity of at least $6 million if it has reported losses from continuing operations, and/or net losses, in its five most recent fiscal years.

Impact of the COVID-19 Pandemic

Since March 2020, the COVID-19 pandemic has caused business closures, severe travel restrictions and implementation of social distancing measures. At the onset of the COVID-19 pandemic and more recently as a result of the recent surge in cases and hospitalizations caused primarily by the Delta variant, hospitals and other medical facilities have cancelled or deferred elective procedures, diverted resources to patients suffering from infections, and limited access for non-patients, including our direct and indirect sales representatives. Because of the COVID-19 pandemic,these circumstances, surgeons and their patients have, been, and may continue to be, required, or are choosing, to, defer procedures in which our products otherwise would be used, andused. In addition, many facilities that specialize in the procedures in which our products otherwise would beare used have experienced staffing shortages, temporary closures, and/or reduced operating hours. hours. These circumstances have negatively impacted, and may continue to negatively impact, the number of elective procedures being conducted and the ability of our employees, independent sales representatives and distributors to effectively market and sell our products, which has had and will likely continue to have a material adverse effect on our revenues. In addition, even after

While eased COVID-19 restrictions caused our revenues to improve in the easingnine months ended September 30, 2021 as compared to the prior year period, the resurgence in cases and hospitalizations during the third quarter of such2021 caused our revenues to decline during the three months ended September 30, 2021 as compared to the prior year period and the second quarter of 2021. Throughout the third quarter of 2021, and most acutely starting in August 2021, spine and other surgery procedure volumes were negatively impacted in many of our key markets, due to cancellations and/or postponements of procedures as a result of increased hospitalizations, restrictions suchon elective procedures and staffing shortages, which negatively impacted our third quarter 2021 revenues. This reduction in elective procedures and staffing issues have continued into the beginning of fourth quarter of 2021 and could continue into 2022 thereby continuing to negatively impact our revenues. Additionally, it is possible that governmental orders no longer prohibitrestrictions could be reinstated due to a resurgence of COVID-19 cases and hospitalizations, whether due to the Delta variant or recommend against performing such procedures, patients maya new variant, or staffing shortages could continue to defer such procedures out of concern of being exposedpersist or worsen, which would continue to coronavirus or for other reasons.adversely impact our revenues.

The COVID-19 pandemic also has also caused adverse effects on general commercial activity and the global economy whichand supply chain, disrupting our ability to obtain raw materials, components and products. The pandemic has ledalsoadversely affected, and may continue to an economic recession and could cause other unpredictable events, any of which could adversely affect, our business, operating results or financial condition. The adverse effect of the pandemic on the broader economy also will likely negatively affect demand for procedures using our products, both in the near- and long-term, and could cause one or more of our distributors, independent sales representatives, customers, contract manufacturers and suppliers to experience financial distress, cancel, postpone or delay orders, be unable to perform under a contract, file for bankruptcy protection, go out of business, or suffer disruptionsand their respective businesses, which in their business. This could impact our ability to manufactureturn, have adversely affected, and provide products and otherwise operate our business, as well as increase our costs and expenses.

The anticipated decline in our revenues and adverse impact on our other operating results could impact our debt covenants under our credit facility and our ability to access funding thereunder. We may need to borrow funds from alternative sources, such as other lenders and institutions or government agencies. There can be no guarantee that such borrowing will be available or available on favorable terms or without restrictions that may otherwise impair our operating flexibility. The COVID-19 pandemic has also led to and could continue to lead to severe disruption and volatility in the global capital markets, which could increase our cost of future capital and adversely affect, our abilitybusiness and operations.

Although we continue to accessmonitor the capital markets in the future.

In response toimpact of the COVID-19 pandemic during the second quarter of 2020, we implemented a series of cost-savings actions intended to preserve capital to support our operations. These temporary cost-saving actions included:

termination or furlough of 42% of our workforce;
suspension in hiring most open positions;
elimination of planned merit increases;
institution of a temporary 20% base salary or wage reduction for all executive officers and employees;
20% reduction in non-employee director retainers for second quarter of 2020;
suspension of future 401(k) plan matching contributions by the Company; and
reduction in sales and marketing expenses and other discretionary spending.

Effective July 1, 2020, we reinstituted the full base salaries and wages of all our employees and restored future 401(k) plan matching contributions.

COVID-19 has resulted and will likely continue to result in a material adverse effect on our business, operatingoperations and financial results, financial condition, prospects and the trading price of our common stock in the near-term and beyond 2020. The full extent to which the COVID-19 pandemic will continue to impact our business will depend on future developments that are highly uncertain and cannot be accurately predicted, including new information that may emerge concerning COVID-19 andvariants, the actions to contain it or treat its impact.impact, the availability, acceptance and effectiveness of vaccines, future resurgences of the virus and its variants, the speed at which government restrictions are lifted, patient capacity at hospitals and healthcare systems, and the willingness and ability of patients to seek care and treatment due to safety concerns or financial hardship. If our revenues continue to decline and do not recover to pre-COVID-19 pandemic levels, we may be required to incur impairment charges to our long-lived assets and goodwill and write-down excess inventory, which would likely adversely affect our future operating results.

See “Risk Factors” in Item 1A of Part II of this report and in Item 1A of Part I of our Annual Report on Form 10-K for the year ended December 31, 2020 as filed with the Securities and Exchange Commission for further information of the possible impact of the COVID-19 pandemic on our business.

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Results of Operations

Comparison of Three and Nine Months Ended September 30, 20202021 and September 30, 20192020

Revenue

Total revenue for the three and nine months ended September 30, 20202021 was $14.0$13.8 million and $39.3$41.3 million, respectively, which represents a decrease of 10.8%1.7% and 17.6%an increase of 5.0%, respectively, compared to $15.7$14.0 million and $47.7$39.3 million for the three and nine months ended September 30, 2019,2020, respectively. The decrease in revenuefor the three-month comparison is largely attributedattributable to the impact of COVID-19 and the sudden dropreductions in elective procedures beginning in early March 2020, which has recovered,our key markets due to some extent,the delta variant of COVID-19. The increase for the nine-month comparison is largely attributable to an increase in elective procedures as evident by third quarter 2020 revenue representing closea result of eased COVID-19 pandemic restrictions during earlier parts of the current year period compared to 90% of third quarter 2019 revenue.the same prior year period.

Cost of Sales and Gross Profit

Cost of sales consists primarily of manufacturing and product purchase costs as well as depreciation of surgical trays. Cost of sales also includes reserves for estimated excess inventory, inventory on consignment that may be missing and not returned, and reserves for estimated missing and damaged consigned surgical instruments. Cost of sales decreasedincreased by 10.2%38.1%, or $0.5$1.8 million, to $6.6 million for the three months ended September 30, 2021 from $4.8 million for the three months ended September 30, 2020 from $5.32020. Cost of sales increased by 18.6%, or $2.6 million, to $16.5 million for the threenine months ended September 30, 2019. Cost of sales decreased by 16.3%, or $2.7 million, to2021 from $13.9 million for the nine months ended September 30, 2020. The increase in cost of sales during the three months ended September 30, 2021 is primarily due to increased under absorption of labor and overhead of $0.8 million driven by initiatives to reduce inventory, additional expense of $0.3 million related to increased reserve expense for excess and obsolete inventory with the remaining increase resulting primarily from sales mix and sell through of product subject to greater production costs during prior periods. The increase in cost of sales during the nine months ended September 30, 2021 is primarily due to higher revenue during the nine months ended September 30, 2021 versus the comparable period in 2020, as mentioned above, and increased under absorption of labor and overhead of $1.2 million resulting from $16.6 millionexcess capacity driven by initiatives to reduce inventory and sell through of product subject to greater production costs during prior periods.

Gross profit as a percentage of revenue decreased to 52.2% for the three months ended September 30, 2021 compared to 66.0% for the same period in 2020. Gross profit as a percentage of revenue decreased to 60.0% for the nine months ended September 30, 2019. The reduction2021 compared to 64.6% for the same period in cost of sales is primarily due to lower revenue during2020. Of the three and nine months ended September 30, 2020 versus the comparable periods in 2019, as mentioned above.

Gross profit as a percentage of sales decreased to 66.0%13.8% decrease for the three months ended September 30, 2020 compared2021, 5.6% was due to 66.2%reduced absorption of labor and overhead, a decrease of 2.2% resulted from greater reserve expense for excess and obsolete inventory, 3.4% was due to sales mix including greater sales of lower margin private label and original equipment manufacturer sales, and 3.6% was due to sell through of product subject to greater production costs during prior periods. Of the same period in 2019. Gross profit as a percentage of sales decreased to 64.6%4.6% decrease for the nine months ended September 30, 2020 compared2021, 3.0% was due to 65.2% forreduced absorption of labor and overhead and 1.8% was due to sales mix. We expect higher product costs to continue in future periods but otherwise expect gross profit to improve as the same period in 2019. The reductions during the three and nine months ended September 30, 2020 compared to the same period in the prior year are primarily attributable to diminished economieseffect of scale partially offset by reduced depreciation expense.COVID-19 on surgical procedures diminishes.

General and Administrative

General and administrative expenses consist principally of personnel costs for corporate employees, cash-based and stock-based compensation related costs, and corporate expenses for legal, accounting and professional fees, and occupancy costs. General and administrative expenses decreased 28.0%increased 2.1%, or $1.2$0.1 million, to $3.0$3.1 million for the three months ended September 30, 2020,2021, compared to $4.2$3.0 million for the same period in 2019.2020. General and administrative expenses decreased 20.0%, or $2.6 million, towere $10.3 million for the nine months ended September 30, 2020,2021, which were flat compared to $12.9$10.3 million for the same period in 2019.2020. The decreaseincrease for the three-month comparison is primarily attributable to lower legaladditional salaries and consulting fees of $0.6 million, reduced executive recruiting feeswage expenses of $0.2 million and reduced salaries and wageswrite-offs of product registrations in South America of $0.2 million during the three months ended September 30, 2020.2021, partially offset by reduced expense of $0.5 million related to various employee compensation plans. The decrease for the nine-month comparison is primarily attributable to lower legal and consulting fees of $1.7 million, reducedincludes additional legal settlement expenses of $0.8 million, reduced salaries and wages of $0.6 million and an additional $0.3 million related to various compensation plans during the nine months ended September 30, 2021, partially offset by reduced executive recruiting feesseverance expenses of $0.5 million, and reduced license fees of $0.3$0.7 million during the nine months ended September 30, 2020. This decrease was offset partially by severance expense of $0.7 million and additional stock-based compensation expense of $0.5 million during the nine months ended September 30, 2020. The reduced salaries and wages were due to the reduction in headcount and the temporary 20% salary and wage decreases implemented during the second quarter of 2020 in response to the COVID-19 pandemic.2021.

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Sales and Marketing

Sales and marketing expenses consist primarily of sales commissions, personnel costs for sales and marketing employees, costs for trade shows, sales conventions and meetings, travel expenses, advertising, and other sales and marketing related costs. Sales and marketing expenses decreased 21.2%, or $1.4 million, toof $5.3 million for the three months ended September 30, 2020,2021 were flat compared to $6.7$5.3 million for the same period of 2019.2020. Sales and marketing expenses decreased 20.1%increased 0.9%, or $3.9$0.1 million, to $15.6$15.7 million for the nine months ended September 30, 2020,2021, compared to $19.5$15.6 million for the same period of 2019.2020. The decrease for the three-month comparison is primarily due to the reduction inincluded reduced commissions expense of $0.6 million resulting from a greater mix of private label and original equipment manufacturer sales commissions of $0.5 million due to lower revenues versus the comparable period in 2019 and reduced2020, partially offset by increased salaries and wages of $0.5$0.3 million due to the reduction inincreased headcount implemented during the second quarterand additional marketing and travel expenses of 2020 in response to the COVID-19 pandemic.$0.2 million. The decreaseincrease for the nine-month comparison is primarily due to the reduction inadditional independent agent sales commissions and incentives of $2.4$0.1 million due to lowerhigher revenues versus the comparable period in 2019, reduced salaries and wages of $1.0 million and lower travel expenses of $0.3 million compared to the comparable period in 2019.2020.

Research and Development

Research and development expenses consist primarily of internal costs for the development of new technologies and processes. Research and development expenses ofincreased 49.6% or $0.1 million, to $0.3 million for the three months ended September 30, 2021, compared to $0.2 million for the three months ended September 30, 2020 were comparable to the2020. Research and development expenses increased 36.0%, or $0.2 million, recorded duringto $0.7 million for the threenine months ended September 30, 2019. Research and development expenses decreased 21.6%, or $0.1 million,2021, compared to $0.5 million for the nine months ended September 30, 2020, compared to $0.7 million for2020. These increase in research and development expenses are associated with additional salaries and wages associated with increased headcount during the three and nine months ended September 30, 2019. The reduction in research and development expenses is primarily due to reduced salaries and wages during the nine months ended September 30, 20202021 compared to the prior year period.periods.

Interest Expense

Interest expense is related toconsists of interest incurred from our debt instruments. Interest expense was $0.3 million for the three months ended September 30, 2021 compared to $2.1 million for the three months ended September 30, 2020 compared to $1.22021. Interest expense was $0.5 million for the threenine months ended September 30, 2019. Interest expense was2021 and $5.3 million for the nine months ended September 30, 2020 and $4.5 million for the nine months ended September 30, 2019.2020. The increasedecrease in interest expense during the three and nine months ended September 30, 2020 versus2021 compared to the comparable periods in 2019the prior year resulted from additionalour October 1, 2020 debt restructuring which, among other things, reduced outstanding principal and paid-in-kind interest associated with the First Amendment.by $61.7 million.

Liquidity and Capital Resources

Working Capital

Since our inception, we have financed our operations through primarily operating cash flows, the private placementplacements of equity securities and convertible debt, an equity credit facility, a debt facility, afacilities, common stock rights offering,offerings, and other debt transactions. The following table summarizes our working capital as of September 30, 2021 and December 31, 2020 (in thousands):

  September 30, 2021  December 31, 2020 
Cash and cash equivalents $18,614  $2,341 
Accounts receivable, net  6,321   6,880 
Inventories  19,708   21,408 
Total current assets  45,588   31,365 
Accounts payable  2,355   2,947 
Accrued liabilities  4,079   5,462 
Line of credit  3,488    
Current portion of long-term debt     16,797 
Total current liabilities  10,404   25,649 
Total working capital  35,184   5,716 

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  September 30, 2020  December 31, 2019 
Cash and cash equivalents $2,741  $5,237 
Accounts receivable, net  7,317   10,124 
Inventories  20,671   16,101 
Total current assets  32,385   32,246 
Accounts payable  2,814   2,188 
Accrued liabilities  6,043   6,632 
Total current liabilities  9,331   9,390 
Total working capital  23,054   22,856 
Long-term debt, plus premium and less issuance costs  79,627   76,244 

Our increase in cash and cash equivalents is due primarily to the completion of a private placement of shares of common stock and warrants in February 2021. On February 24, 2021, we issued in a private placement to a single healthcare-focused institutional accredited investor 8,888,890 shares of our common stock at a purchase price of $2.25 per share, and a warrant to purchase up to 6,666,668 shares of our common stock. The warrant has an exercise price of $2.25 per share, subject to customary anti-dilution, but not price protection, adjustments, is immediately exercisable and expires on the five-year anniversary of the date of issuance. We received net proceeds of approximately $18.4 million, after deducting fees and other estimated offering expenses, from the private placement. We expect to use these net proceeds for working capital and other general corporate purposes.

Cash Flows

Net cash used inprovided by operating activities for the first nine months of 20202021 was $1.6 million$16 thousand attributed primarily to the increase in inventories of $5.0 million and increase in prepaid expenses of $0.9 million, offset partiallycash generated by the decrease inreductions to accounts receivable of $2.5$0.6 million and increasefinished goods and work in accounts payableprocess inventories of $0.6 million.$3.9 million, partially offset by reductions to accrued liabilities of $1.4 million and increases to raw materials of $2.2 million in connection with realignments of the Company’s procurement and production processes. For the comparable period of 2019,2020, net cash used in operating activities was $0.3$1.6 million.

Net cash used in investing activities for the first nine months of 2021 and 2020 and 2019 was $0.8$1.3 million and $0.2$0.7 million, respectively, primarily representing purchases of property and equipment.

Net cash provided by financing activities was $17.6 million for the first nine months of 2021, which was primarily attributable to $18.4 million of proceeds from our February 2021 private placement, net of issuance costs. Net cash used in financing activities was $0.1 million and $0.5 million for the first nine monthscomparable period of 20202020.

Current and 2019, respectively, primarily representing payments for financing leases.Prior Credit Facilities

Credit Facility

On March 29, 2019, weMay 6, 2021, the Company, as guarantor, and our subsidiaries, as borrowers (collectively, the “Borrowers”), entered into a Credit, Security and Guaranty Agreement (Term Loan) (the “Term Credit Agreement”) and Credit, Security and Guaranty Agreement (Revolving Loan) (the “Revolving Credit Agreement” and, together with the Second Amended and RestatedTerm Credit Agreement, the “Credit Agreements”) with the Lenders. MidCap Financial Trust, in its capacity as agent (“MidCap”).

The Second Amended and RestatedTerm Credit Agreement amended the Prior Credit Agreement to provide that we may requestprovides for a secured term loans from the Lenders in their sole discretion in an amount equal to the remaining availability for additional delayed draw loans, which was approximately $2.2 million as of the date of the Second Amended and Restated Credit Agreement, and request additional term loans from the Lenders in their sole discretionloan facility (the “Term Facility”) in an aggregate principal amount of up$12.0 million (the “Term Loan Commitment”), which was funded to $10.0the Borrowers immediately, and an additional $5.0 million tranche available solely at the amountdiscretion of each loan draw to be also subject to our production of a thirteen-week cash flow forecast that is approved byMidCap and the Lenders and which shows a projected cash balancelenders, for the following two-week periodpurposes agreed to between the Company, the Borrowers and the lenders in advance of less than $1.5 million, as well as the satisfaction (or waiver in writing by each Lender)making of conditions precedent, including closing certificate, delivery of a budget, and other satisfactory documents. In addition, the Second Amended and Restatedloans under such additional tranche. The Revolving Credit Agreement provides that (i) no interest will accruefor a secured revolving credit facility (the “Revolving Facility,” and, together with the Term Facility, the “Facilities”) under which the Borrowers may borrow up to $8.0 million (such amount, the “Revolving Loan Commitment”) at any one time, the availability of which is determined based on a borrowing base equal to percentages of certain accounts receivable and inventory of the loans thereunder fromBorrowers in accordance with a formula set forth in the Revolving Credit Agreement. All borrowings under the Revolving Facility are subject to the satisfaction of customary conditions, including the absence of default, the accuracy of representations and after January 1, 2019 until March 31, 2020; (ii) beginning April 1, 2020, throughwarranties in all material respects and the delivery of an updated borrowing base certificate.

The Facilities have a maturity date of May 1, 2026. Each of the Second AmendedBorrowers, and Restated Credit Agreement, interest payable in cash will accruethe Company, as guarantor, are jointly and severally liable for all of the obligations under the Facilities on the terms set forth in the Credit Agreements. The Borrowers’ obligations, and the Company’s obligations as a guarantor, under the Credit Agreements are secured by first-priority liens on substantially all of their assets, including, without limitation, all inventory, equipment, accounts, intellectual property and other assets of the Company and the Borrowers.

The proceeds of the Term Facility were used to pay transaction fees in connection with the Facilities and to pay in full all outstanding indebtedness and accrued interest under the Company’s prior credit facility, which is described below. The proceeds of the Revolving Facility may be used to pay transaction fees in connection with the Facilities, to pay in full all outstanding indebtedness and accrued interest under the Company’s prior credit facility, and for working capital and general corporate purposes.

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The loans thereunderand other obligations pursuant to the Credit Agreements bear interest at a rate per annum rate equal to the sum of (a) 10.00% plus (b) the higher of (x) the LIBO Rate (asLIBOR rate, as such term is defined in the Second Amended and Restated Credit Agreement) and (y) 2.3125%; (iii)Agreements, plus the maturity dateapplicable margin of 7.00% in the case of the loans thereunder is March 31, 2021; (iv) the Consolidated Senior Leverage RatioTerm Credit Agreement, and Consolidated EBITDA (as such terms were defined4.50% in the Priorcase of the Revolving Credit Agreement) financialAgreement, subject in each case to a LIBOR floor of 1.00%.

The Credit Agreements contain affirmative and negative covenants were deletedcustomarily applicable to senior secured credit facilities, including covenants that, among other things, limit or restrict the ability of the Borrowers, subject to negotiated exceptions, to incur additional indebtedness and additional liens on their assets, engage in mergers or acquisitions or dispose of assets, pay dividends or make other distributions, voluntarily prepay other indebtedness, enter into transactions with affiliated persons, make investments, and change the nature of their businesses. In addition, the Credit Agreements require the Borrowers and the Company to maintain net product revenue at or above minimum levels and to maintain a minimum adjusted EBITDA and a new Revenue Base (as such term is definedminimum liquidity, in each case at levels specified in the Second Amended and Restated Credit Agreement) financial covenant was added; and (v) the key person event default provision was revised to refer specifically to certain then recently-hired executive officers of the Company.

On May 6, 2020, we entered into a First Amendment to the Second Amended and Restated Credit Agreement with the Lenders, which amended the Second Amended and Restated Credit Agreement. Under the terms of the First Amendment, the Second Amended and Restated Credit Agreement was amended to provide that:

No interest will accrue on the outstanding loans under the Second Amended and Restated Credit Agreement from and after March 31, 2020 until September 30, 2020;
Beginning October 1, 2020 through the maturity date of the Second Amended and Restated Credit Agreement, interest payable in cash will accrue on the loans under the Second Amended and Restated Credit Agreement at a rate per annum equal to the sum of (i) 10.00% plus (ii) the higher of (x) the LIBO Rate (as such term is defined in the Second Amended and Restated Credit Agreement) and (y) 2.3125%;
The maturity date of the loans thereunder is December 31, 2021;
The Revenue Base financial covenant was revised through December 31, 2021; and
The key person event default provision was revised to refer specifically to Sean Browne in lieu of a former executive.

On August 7, 2020, we entered into the Restructuring Agreement with the Lenders, pursuant to which the parties thereto agreed, subject to the terms and conditions set forth therein, to take certain actions as set forth therein in furtherance of a restructuring of the Company’s outstanding indebtedness under Second Amended and Restated Credit Agreement. The Restructuring Transactions and other details related thereto are described above under “Recent Debt Restructuring.” As part of the Restructuring Transactions, we entered into a Second Amendment to the Second Amended and Restated Credit Agreement with the Lenders, which amended the Second Amended and Restated Credit Agreement as follows:

extinguished loans in an aggregate principal amount equal to the Exchanging Loans outstanding thereunder on the Closing Date, immediately prior to the Closing, together with all accrued and unpaid interest thereon;
added loans in an aggregate principal amount equal to a portion of the prepayment fee payable thereunder in respect of the Exchanging Loans and exchanged the remaining portion of the prepayment fee for an additional 0.9 million shares of common stock;
removed the availability of the Additional Delayed Draw Loans and reduced the Additional Second Delayed Draw Commitment Amount (as such terms are defined in the Second Amended and Restated Credit Agreement) to $5.0 million;
provided that beginning on October 1, 2020 through the maturity date of the Second Amended and Restated Credit Agreement, interest payable in cash will accrue on the loans thereunder at a rate per annum equal to the sum of (i) 7.00% plus (ii) the higher of (x) the LIBO Rate (as such term is defined in the Second Amended and Restated Credit Agreement) and (y) 1.00%; and
eliminated the Revenue Base financial covenant.

Agreements. As of September 30, 2020,2021, we were in compliance with all covenants under the Credit Agreements.

On May 6, 2021, contemporaneously with the execution and delivery of the Credit Agreements, that certain Second Amended and Restated Credit Agreement, dated March 29, 2019, among the Company, the Borrowers, OrbiMed Royalty Opportunities II, LP (“Royalty Opportunities”) and ROS Acquisition Offshore LP (“ROS”), as subsequently amended (the “Second A&R Credit Agreement”), which was scheduled to mature on December 31, 2021, was terminated in accordance with the terms thereof and all outstanding amounts were repaid by the First Amendment.Borrowers to Royalty Opportunities in its role as sole lender thereunder.

Cash Requirements

AsWe believe that our $18.6 million of September 30, 2020, our cash and cash equivalents were $2.7 million. We believe that our cash and cash equivalents,as of September 30, 2021, together with amounts available under the current $5.0 million availability under our credit facility which is subject to the sole discretion of the Lenders,Facilities, will be sufficient to meet our anticipated cash requirements forthrough at least the next 12 months.November 2022. However, we may require or seek additional financingcapital to fund our future operations and business strategy.strategy prior to November 2022. Accordingly, there is no assurance that we will not need or seek additional financing prior to such time, especially in light of the December 31, 2021 maturity date under our credit facility. time.

We may elect to raise additional financing even before we need themit if market conditions for raising additional capital are favorable. We may seek to raise additional financing through various sources, such as debt refinancings, equity and debt financings, additional debt restructurings or refinancings, or through strategic collaborations and license agreements. We can give no assurances that we will be able to refinance our existing indebtedness or secure additional sources of funds to support our operations, or if such financing isfunds are available to us, that such additional financing will be sufficient to meet our needs or on terms acceptable to us. This is particularly true if economic and market conditions deteriorate.

To the extent that we raise additional capital through the sale of equity or convertible debt securities or the restructuring or refinancing of our debt, the interests of our current stockholders may be diluted, and the terms may include discounted equity purchase prices, warrant coverage, liquidation or other preferences that would adversely affect the rights of our current stockholders. If we issue common stock, we may do so at purchase prices that represent a discount to our trading price and/or we may issue warrants to the purchasers, which could dilute our current stockholders. If we issue preferred stock, it could adversely affect the rights of our stockholders or reduce the value of our common stock. In particular, specific rights granted to future holders of preferred stock may include voting rights, preferences as to dividends and liquidation, conversion and redemption rights, sinking fund provisions, and restrictions on our ability to merge with or sell our assets to a third party. Additional debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Prior to raising additional equity or debt financing, we mustmay be required to obtain the consent of the Lenders,Agent under our Credit Agreements and/or ROS and Royalty Opportunities under our Investor Rights Agreement with them, and no assurance can be provided that the Lendersthey would provide such consent, which could limit our ability to raise additional financing.financing and the terms thereof.

Off Balance Sheet Arrangements

We do not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity or capital expenditures, or capital resources that are material to an investor in our common stock.

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Critical Accounting Estimates

Management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these financial statements requires us to make estimates and assumptions for the reported amounts of assets, liabilities, revenue, expenses, and related disclosures. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions, and any such differences may be material.

There have been no changes in our critical accounting estimates for the three and nine months ended September 30, 20202021 as compared to the critical accounting estimates described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019 other than for adoption of ASU 2016-13 as described in Note 1 and Note 3 to our condensed consolidated financial statements.2020.

ITEM 3.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

As a smaller reporting company, we are not required to provide the information required by this Item.

ITEM 4.Controls and ProceduresCONTROLS AND PROCEDURES

Limitations on Effectiveness of Controls and Procedures

In designing and evaluating our disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management is required to apply judgment in evaluating the benefits of possible controls and procedures relative to their costs.

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Exchange Act) as of September 30, 2020.2021. Based upon that evaluation, our principal executive officer and principal financial officer concluded that as of September 30, 2020,2021, our disclosure controls and procedures were effective.

Changes in Internal Control over Financial Reporting

There were no changes in the Company’s internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the three months ended September 30, 2020,2021, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II.OTHER INFORMATION

PART II. OTHER INFORMATION

ITEM 1.Legal ProceedingsLEGAL PROCEEDINGS

We are subject to potential liabilities under government regulations and various claims and legal actions that are pending or may be asserted from time to time. These matters arise in the ordinary course and conduct of our business and may include, for example, commercial, product liability, intellectual property, and employment matters. We intend to continue to defend the Company vigorously in such matters and when warranted, take legal action against others.Not applicable.

ItemITEM 1A.Risk FactorsRISK FACTORS

Although Item 1A is inapplicable to Xtant as a smaller reporting company, we hereby disclose the following additional risk:

The Company’sOur business, operating results and financial condition have been and will likely continue to be materially adversely affected by the global novel strain of coronavirus (COVID-19)COVID-19 pandemic.

Since March 2020, the COVID-19 pandemic has caused business closures, severe travel restrictions and implementation of social distancing measures. At the onset of the COVID-19 pandemic and more recently as a result of the recent surge in cases and hospitalizations caused by the Delta variant, hospitals and other medical facilities have cancelled or deferred elective procedures, diverted resources to patients suffering from infections, and limited access for non-patients, including our direct and indirect sales representatives. Because of the COVID-19 pandemic,these circumstances, surgeons and their patients have, been, and may continue to be, required, or are choosing, to, defer procedures in which our products otherwise would be used, andused. In addition, many facilities that specialize in the procedures in which our products otherwise would beare used have experienced staffing shortages, temporary closures, and/or reduced operating hours. These circumstances have negatively impacted, and may continue to negatively impact, the number of elective procedures being conducted and the ability of our employees, independent sales representatives and distributors to effectively market and sell our products, which has had and will likely continue to have a material adverse effect on our revenues. In addition, even after

20

The resurgence in cases and hospitalizations during the easingthird quarter of such2021 caused our revenues to decline during the three months ended September 30, 2021 as compared to the prior year period and the second quarter of 2021. Throughout the third quarter of 2021, and most acutely starting in August 2021, spine and other surgery procedure volumes were negatively impacted in many of our key markets, due to cancellations and/or postponements of procedures as a result of increased hospitalizations, restrictions suchon elective procedures and staffing shortages, which negatively impacted our third quarter 2021 revenues. This reduction in elective procedures and staffing issues have continued into the beginning of fourth quarter of 2021 and could continue into 2022 thereby continuing to negatively impact our revenues. Additionally, it is possible that governmental orders no longer prohibitrestrictions could be reinstated due to a resurgence of COVID-19 cases and hospitalizations, whether due to the Delta variant or recommend against performing such procedures, patients maya new variant, or staffing shortages could continue to defer such procedures out of concern of being exposedpersist or worsen, which would continue to coronavirus or for other reasons.adversely impact our revenues.

The COVID-19 pandemic also has also caused adverse effects on general commercial activity and the global economy, which has led to an economic slowdown and recession and could cause other unpredictable events, any of which could adversely affect our business, operating results or financial condition. The adverse effect of the pandemic on the broader economy also will likely negatively affect demand for procedures using our products, both in the near- and long-term. In addition, asThe pandemic also has disrupted the global supply chain, impacting our ability to obtain raw materials, components and products. The pandemic has also adversely affected, and may continue to adversely affect, our distributors, independent sales representatives, customers, contract manufacturers and suppliers and their respective businesses, which in turn, have adversely affected, and may continue to adversely affect, our business and operations. As a result of this negative effect of the pandemic on our economy, one or more of our distributors, independent sales representatives, customers, contract manufacturers and suppliers may experience financial distress, cancel, postpone or delay orders, be unable to perform under a contract, file for bankruptcy protection, go out of business, or suffer disruptions in their business or we may need to offer special payment terms or relief to our distributors, independent sales representatives and customers. Accordingly, we believe we will beare exposed to heightened credit risk as a result of the pandemic. This could adversely impact our ability to manufacture and provide products and otherwise operate our business, as well as increase our costs and expenses.

The anticipatedCOVID-19 pandemic has also led to and could continue to lead to severe disruption and volatility in the global capital markets, which could increase our cost of future capital and adversely affect our ability to access the capital markets in the future. The decline in our revenues and adverse impact of the pandemic on our other operating results could impact our debt covenants under our credit facility and our ability to access funding thereunder.thereunder or refinance that debt or extend its maturity date. We may need to borrow funds from alternative sources, such as other lenders and institutions or government agencies. There can be no guarantee that such borrowing will be available or available on favorable terms or without restrictions that may otherwise impair our operating flexibility. The COVID-19 pandemic has also led to and could continue to lead to severe disruption and volatility in the global capital markets, which could increase our cost of future capital and adversely affect our ability to access the capital markets in the future.

The foregoing and other continued disruptions to our business as a result of COVID-19 have resulted, and could continue to result, in a material adverse effect on our business, operating results, financial condition, prospects and the trading price of our common stock inthroughout 2021. Although we continue to monitor the near-termimpact of the COVID-19 pandemic on our business, operations and beyond 2020. Thefinancial results, the full extent to which the COVID-19 pandemic will continue to impact our business will depend on future developments that are highly uncertain and cannot be accurately predicted, including new information that may emerge concerning COVID-19 andvariants, the actions to contain it or treat its impact. impact, the availability, acceptance and effectiveness of vaccines, future resurgences of the virus and its variants, the speed at which government restrictions are lifted, patient capacity at hospitals and healthcare systems, and the willingness and ability of patients to seek care and treatment due to safety concerns or financial hardship.

21

No assurance can be provided that our revenues will ever return to pre-COVID-19 levels. If our revenues continue to decline and do not recover to pre-COVID-19 pandemic levels, we may be required to incur impairment charges to our long-lived assets and goodwill, and we could experience an increase in the amount of excess inventory quantities on hand and be required to recognize inventory write-downs, each or all of which could adversely affect our future results of operations.

The COVID-19 pandemic also heightens the risks in certain of the other risk factors described in our Annual Report on Form 10-K for the year ended December 31, 2019.2020.

ITEM 2.Unregistered Sales of Equity Securities and Use of ProceedsUNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

Not applicable.

ITEM 3.Defaults Upon Senior SecuritiesDEFAULTS UPON SENIOR SECURITIES

Not applicable.

ITEM 4.Mine Safety DisclosuresMINE SAFETY DISCLOSURES

Not applicable.

ITEM 5.Other InformationOTHER INFORMATION

Not applicable.Change of Transfer Agent

We have appointed Broadridge Corporate Issuers Solutions, Inc. (“Broadridge”) as the transfer agent and registrar of our common stock effective as of November 5, 2021. Beginning November 5, 2021, Xtant stockholder inquiries can be directed to Broadridge at the following address, phone number, and e-mail address:

Mail:Xtant Medical Holdings, Inc.
c/o Broadridge Corporate Issuer Solutions
P.O. Box 1342
Brentwood, NY 11717

Overnight Packages:Xtant Medical Holdings, Inc.
c/o Broadridge Corporate Issuer Solutions
1155 Long Island Ave.
Edgewood, NY 11717

Phone:877-830-4936

E-mail:shareholder@broadridge.com

ITEM 6.ExhibitsEXHIBITS

The following exhibits are being filed or furnished with this Quarterly Report on Form 10-Q:

Exhibit No.Description
3.1Amended and Restated Certificate of Incorporation of Xtant Medical Holdings, Inc. (filed as Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed with the SEC on February 13, 2018 (SEC File No. 001-34951) and incorporated by reference herein).
3.2Certificate of Amendment of the Amended and Restated Certificate of Incorporation of Xtant Medical Holdings, Inc. (filed as Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed with the SEC on October 31, 2019 (SEC File No. 001-34951) and incorporated by reference herein).
3.3Certificate of Amendment of the Amended and Restated Certificate of Incorporation of Xtant Medical Holdings, Inc., as amended (filed as Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed with the SEC on October 1, 2020 (SEC File No. 001-34951) and incorporated by reference herein).
3.4Second Amended and Restated Bylaws of Xtant Medical Holding,Holdings, Inc. (filed as Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed with the SEC on February 16, 2018 (SEC File No. 001-34951) and incorporated by reference herein).
10.131.1Restructuring and Exchange Agreement, dated as of August 7, 2020, by and among Xtant Medical Holdings, Inc., OrbiMed Royalty Opportunities II, LP and ROS Acquisition Offshore LP (filed as Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed with the SEC on August 10, 2020 (SEC File No. 001-34951) and incorporated by reference).
10.2Second Amendment to Second Amended and Restated Credit Agreement effective as of October 1, 2020 among Xtant Medical Holdings, Inc., Bacterin International, Inc., Xtant Medical, Inc., X-spine Systems, Inc., OrbiMed Royalty Opportunities II, LP and ROS Acquisition Offshore LP (filed as Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed with the SEC on October 1, 2020 (SEC File No. 001-34951) and incorporated by reference).
10.3Registration Rights Agreement, dated as of October 1, 2020, by and among Xtant Medical Holdings, Inc., OrbiMed Royalty Opportunities II, LP and ROS Acquisition Offshore LP (filed as Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed with the SEC on October 1, 2020 (SEC File No. 001-34951) and incorporated by reference).
31.1Certification of Chief Executive Officer pursuant to Exchange Act Rules 13a-14(a)/15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith).
31.2Certification of Chief Financial Officer pursuant to Exchange Act Rules 13a-14(a)/15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith).
32.1Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (furnished herewith).
32.2Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (furnished herewith).
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The following materials from Xtant’s Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2020,2021, formatted in Inline XBRL (Extensible Business Reporting Language): (i) the unaudited Condensed Consolidated Balance Sheets, (ii) the unaudited Condensed Consolidated Statements of Operations, (iii) the unaudited Condensed Consolidated Statements of Equity, (Deficit), (iv) the unaudited Condensed Consolidated Statements of Cash Flows, and (v) Notes to Condensed Consolidated Financial Statements (filed herewith).

104Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

XTANT MEDICAL HOLDINGS, INC.
Date: November 12, 2021By:/s/ Sean E. Browne
Name:Sean E. Browne
Title:President and Chief Executive Officer
(Principal Executive Officer)
   
Date: October 29, 2020November 12, 2021By:/s/ Sean E. Browne
Name:Sean E. Browne
Title:President and Chief Executive Officer
(Principal Executive Officer)

Date: October 29, 2020By:/s/ Greg Jensen
Name:Greg Jensen
Title:Vice President, Finance and Chief Financial Officer
(Principal Financial Officer and Principal Accounting Officer)

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