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 June 30, 2020March 31, 2021

 

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)

 

Delaware 20-5313323

(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 class Trading Symbol(s) Name of each exchange on which registered
Common stock, par value $0.000001 per share XTNT NYSE 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 July 31, 2020: 13,223,565.May 4, 2021: 86,707,286.

 

 

  

 

 

 

XTANT MEDICAL HOLDINGS, INC.
FORM 10-Q

FORM 10-Q

June 30, 2020March 31, 2021

 

TABLE OF CONTENTS

 

  Page
   
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTSii1
PART I.FINANCIAL INFORMATION13
ITEM 1.FINANCIAL STATEMENTSFinancial statements13
ITEM 2.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSManagement’s Discussion and Analysis of Financial Condition and Results of Operations1517
ITEM 3.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISKQuantitative and Qualitative Disclosures About Market Risk2022
ITEM 4.CONTROLS AND PROCEDURESControls and Procedures2022
PART II.OTHER INFORMATION2023
ITEM 1.LEGAL PROCEEDINGSLegal Proceedings2023
ITEM
Item 1A.RISK FACTORSRisk Factors2023
ITEM 2.UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDSUnregistered Sales of Equity Securities and Use of Proceeds2123
ITEM 3.DEFAULTS UPON SENIOR SECURITIESDefaults Upon Senior Securities2123
ITEM 4.MINE SAFETY DISCLOSURESMine Safety Disclosures2123
ITEM 5.OTHER INFORMATIONOther Information2223
ITEM 6.EXHIBITSExhibits23

 

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 on our business, operating results and financial condition, including disruption to our customers, distributors, independent sales representatives, contract manufacturers and suppliers, as well as the global economy and financial and credit markets;
   
 our ability to increase or maintain revenue or return to pre-COVID-19 revenue levels within an acceptable time period or at all;
the ability of our sales personnel, including our independent sales agents and distributors, to achieve expected results;
our ability to develop and market 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;
our dependence on and ability to retain and recruit independent sales agents and distributors;
our ability to retain and expand our agreements with group purchasing organizations and independent delivery networks;

our success in implementing key growth initiatives designed to increase our revenue and scale;

our success in implementing inventory reduction initiatives designed to improve our working capital;

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;
product liability claims and other litigation to which we may be subjected;
product recalls and defects;
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;
the availability of our facilities;
our ability to comply with the covenants in our second amended and restated credit agreement;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;
our ability to increase or maintain revenue;
the ability of our sales force to achieve expected results;
our ability to innovate and develop new products;
our ability to remain competitive;
our ability to obtain donor cadavers for our products;
our ability to engage and retain qualified technical personnel and members of our management team;
the availability of our facilities;
our ability to retain and recruit independent sales agents and the impact of the termination of an advisory agreement with an entity that provided services to some of our customers;
government regulations;
government and third-party coverage and reimbursement for our products;
our ability to obtain and maintain regulatory approvals in the United States and abroad;
our ability to successfully integrate future business combinations or acquisitions;
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;
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
   
 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.

 

 ii2 

 

 

PART I. FINANCIAL INFORMATION

PART I.FINANCIAL INFORMATION

 

ITEM 1.FINANCIAL STATEMENTSFinancial statements

 

XTANT MEDICAL HOLDINGS, INC.

Condensed Consolidated Balance Sheets

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

 

 

As of
June 30, 2020

  

As of
December 31, 2019

  As of March 31, 2021  As of December 31, 2020 
 (Unaudited)     (Unaudited)    
ASSETS                
Current Assets:                
Cash and cash equivalents $3,019  $5,237  $18,643  $2,341 
Trade accounts receivable, net of allowance for credit losses of $728 and doubtful accounts of $500, respectively  7,583   10,124 
Trade accounts receivable, net of allowance for credit losses and doubtful accounts of $554 and $653, respectively  7,027   6,880 
Inventories  19,888   16,101   21,641   21,408 
Prepaid and other current assets  899   784   1,165   736 
Total current assets  31,389   32,246   48,476   31,365 
Property and equipment, net  4,256   4,695   4,666   4,347 
Right-of-use asset, net  1,898   2,100   1,585   1,690 
Goodwill  3,205   3,205   3,205   3,205 
Intangible assets, net  486   515   443   457 
Other assets  432   394   322   402 
Total Assets $41,666  $43,155  $58,697  $41,466 
                
LIABILITIES & STOCKHOLDERS’ EQUITY (DEFICIT)        
LIABILITIES & STOCKHOLDERS’ EQUITY        
Current Liabilities:                
Accounts payable $3,072  $2,188  $2,490  $2,947 
Accrued liabilities  5,894   6,632   4,569   5,462 
Current portion of lease liability  408   394   431   423 
Current portion of financing lease obligations  101   176 
Current portion of finance lease obligations  30   20 
Current portion of long-term debt  16,490   16,797 
Total current liabilities  9,475   9,390   24,010   25,649 
Long-term Liabilities:                
Lease liability, less current portion  1,518   1,726   1,192   1,303 
Long-term debt, plus premium and less issuance costs  77,531   76,244 
Finance lease obligation, less current portion  129    
Total Liabilities  88,524   87,360   25,331   26,952 
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; 13,223,565 shares issued and outstanding as of June 30, 2020 and 13,161,762 shares issued and outstanding as of December 31, 2019      
Common stock, $0.000001 par value; 300,000,000 shares authorized; 86,707,286 shares issued and outstanding as of March 31, 2021 and 77,573,680 shares issued and outstanding as of December 31, 2020      
Additional paid-in capital  181,412   179,061   263,731   244,850 
Accumulated deficit  (228,270)  (223,266)  (230,365)  (230,336)
Total Stockholders’ Equity (Deficit)  (46,858)  (44,205)
Total Liabilities & Stockholders’ Equity (Deficit) $41,666  $43,155 
Total Stockholders’ Equity  33,366   14,514 
Total Liabilities & Stockholders’ Equity $58,697  $41,466 

 

See notes to unaudited condensed consolidated financial statements.

 

13 

 

 

XTANT MEDICAL HOLDINGS, INC.

Condensed Consolidated Statements of Operations

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

 

 

Three Months Ended

June 30,

 

Six Months Ended

June 30,

  Three Months Ended
March 31,
 
 2020  2019  2020  2019  2021  2020 
Revenue                        
Orthopedic product sales $10,493  $15,197  $25,227  $31,883  $12,509  $14,735 
Other revenue  36   74   80   114   33   43 
Total Revenue  10,529   15,271   25,307   31,997   12,542   14,778 
                        
Cost of sales  3,979   5,365   9,144   11,278   4,451   5,165 
Gross Profit  6,550   9,906   16,163   20,719   8,091   9,613 
                        
Operating Expenses                        
General and administrative  2,931   4,187   7,250   8,664   3,027   4,318 
Sales and marketing  3,895   6,072   10,309   12,814   4,855   6,413 
Research and development  111   210   353   472   214   245 
Total Operating Expenses  6,937   10,469   17,912   21,950   8,096   10,976 
                        
Loss from Operations  (387)  (563)  (1,749)  (1,231)  (5)  (1,363)
                        
Other (Expense) Income                
Other Expense        
Interest expense  (2,054)  (1,301)  (3,163)  (3,319)  1   1,108 
Other (expense) income  -   (53)  -   (143)
Total Other (Expense)  (2,054)  (1,354)  (3,163)  (3,462)
Total Other Expense  1   1,108 
                        
Net Loss Before Provision for Income Taxes  (2,441)  (1,917)  (4,912)  (4,693)  (6)  (2,471)
                        
Provision for income taxes  (23)  (22)  (45)  (45)  (23)  (22)
Net Loss $(2,464) $(1,939) $(4,957) $(4,738) $(29) $(2,493)
                        
Net loss per share:                        
Basic $(0.19) $(0.15) $(0.38) $(0.36) $(0.00) $(0.19)
Dilutive $(0.19) $(0.15) $(0.38) $(0.36) $(0.00) $(0.19)
                        
Shares used in the computation:                        
Basic  13,223,565   13,161,762   13,199,455   13,166,136   81,248,875   13,175,345 
Dilutive  13,223,565   13,161,762   13,199,455   13,166,136   81,248,875   13,175,345 

 

See notes to unaudited condensed consolidated financial statements.

 

24 

 

 

XTANT MEDICAL HOLDINGS, INC.

Condensed Consolidated Statements of Equity

(Unaudited, in thousands, except number of shares)

 

STOCKHOLDERS’ EQUITY – THREE MONTHS ENDED JUNE 30MARCH 31

 

  Common Stock  Additional  Retained  

Total

Stockholders’

 
  Shares  Amount  

Paid-In-Capital

  Deficit  Equity (Deficit) 
Balance at March 31, 2019  13,161,762  $  $178,668  $(217,844) $(39,176)
                     
Stock-based compensation        39      39 
Net loss           (1,939)  (1,939)
Balance at June 30, 2019  13,161,762  $  $178,707  $(219,783) $(41,076)
                     
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)

STOCKHOLDERS’ EQUITY – SIX MONTHS ENDED JUNE 30

 Common Stock Additional Retained  

Total

Stockholders’

  Common Stock  Additional Paid-In- Retained Total
Stockholders’ Equity
 
 Shares Amount  

Paid-In-Capital

  Deficit Equity (Deficit) 
Balance at December 31, 2018  13,172,179  $  $171,273  $(215,045) $(43,772)
                    
Stock-based compensation        161      161 
Forfeiture of restricted stock  (10,417)            
Debt extinguishment        7,264      7,264 
Issuance of warrant        9      9 
Net loss           (4,738)  (4,738)
Balance at March 31, 2019  13,161,762  $  $178,707  $(219,783) $(41,076)
                     Shares  Amount  Capital  Deficit  (Deficit) 
Balance at December 31, 2019  13,161,762  $  $179,061  $(223,266) $(44,205)  13,161,762  $  $179,061  $(223,266) $(44,205)
                                        
ASU 2016-13 cumulative effect adjustment           (47)  (47)           (47)  (47)
Common stock issued on vesting of restricted stock units  61,803               61,803             
Issuance of warrant        1,862      1,862 
Stock-based compensation        489      489         269      269 
Net loss           (4,957)  (4,957)           (2,493)  (2,493)
Balance at June 30, 2020  13,223,565  $  $181,412  $(228,270) $(46,858)
Balance at March 31, 2020  13,223,565  $  $179,330  $(225,806) $(46,476)
                    
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 
Common stock issued on vesting of restricted stock units  244,716             
Stock-based compensation        456      456 
Net loss           (29)  (29)
Balance at March 31, 2021  86,707,286  $  $263,731  $(230,365) $33,366 

 

See notes to unaudited condensed consolidated financial statements.

 

35 

 

 

XTANT MEDICAL HOLDINGS, INC.

Condensed Consolidated Statements of Cash Flows

(Unaudited, in thousands)

 

 

Six Months Ended

June 30,

  Three Months Ended
March 31,
 
 2020  2019  2021  2020 
Operating activities:                
Net loss $(4,957) $(4,738) $(29) $(2,493)
Adjustments to reconcile net loss to net cash provided by operating activities:        
Adjustments to reconcile net loss to net cash used in operating activities:        
Depreciation and amortization  1,153   1,559   375   685 
(Gain) loss on disposal of fixed assets  (118)  92 
Gain on disposal of fixed assets  (32)  (105)
Non-cash interest  3,149   3,272      1,101 
Non-cash rent  8   11   3   4 
Stock-based compensation  489   161   456   269 
Provision for reserve on accounts receivable  204   232   (63)  138 
Provision for excess and obsolete inventory  377   518   150   31 
                
Changes in operating assets and liabilities:                
Accounts receivable  2,290   1,403   (83)  195 
Inventories  (4,164)  955   (383)  (1,974)
Prepaid and other assets  (153)  242   (349)  (340)
Accounts payable  884   (3,481)  (459)  1,610 
Accrued liabilities  (738)  728   (893)  (910)
Net cash (used in) provided by operating activities  (1,576)  954 
Net cash used in operating activities  (1,307)  (1,789)
                
Investing activities:                
Purchases of property and equipment and intangible assets  (673)  (211)  (542)  (258)
Proceeds from sale of fixed assets  106   163   59   83 
Net cash used in investing activities  (567)  (48)  (483)  (175)
                
Financing activities:                
Payments on financing leases  (75)  (277)  (25)  (34)
Costs associated with Second Amended and Restated Credit Agreement     (108)
Net cash used in financing activities  (75)  (385)
Payments on long-term debt  (308)   
Proceeds from private placement, net of cash issuance costs  18,425    
Net cash provided by (used in) financing activities  18,092   (34)
                
Net change in cash and cash equivalents  (2,218)  521   16,302   (1,998)
Cash and cash equivalents at beginning of period  5,237   6,797   2,341   5,237 
Cash and cash equivalents at end of period $3,019  $7,318  $18,643  $3,239 

 

See notes to unaudited condensed consolidated financial statements.

 

46 

 

 

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,”“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.

 

The global novel strain of coronavirus, orSince March 2020, the COVID-19 pandemic has led to the closure of businesses,caused business closures, severe travel restrictions and implementation of social distancing measures. HospitalsAt the onset of the COVID-19 pandemic, 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, surgeons and their patients arehave been, and may continue to be, required, or are choosing, to defer procedures in which our products otherwise would be used, and many facilities that specialize in the procedures in which our products otherwise would be used have temporarily closedexperienced temporary closures or reduced operating hours. These circumstances have negatively impacted, and may continue to negatively impact, 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.

 

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.

 

ReclassificationsPrivate Placement

 

Certain prior year amounts have been reclassifiedOn February 24, 2021, we issued in a private placement (the “Private Placement”) to conform with current year presentation.a single healthcare-focused institutional accredited investor (the “Investor”) 8,888,890 shares of our common stock at a purchase price of $2.25 per share, and warrants to purchase 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 estimated offering expenses, from the Private Placement.

 

Recent Accounting Pronouncements

In June 2016,The Investor Warrant, described in more detail in Note 10, “Warrants”, has an exercise price of $2.25 per share, subject to customary anti-dilution, but not price protection, adjustments, and will be immediately exercisable and expire on the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-13, Financial Instruments–Credit Losses: Measurementfive-year anniversary of Credit Losses on Financial Instruments to change the impairment model for most financial assets and certain other instruments. For trade and other receivables, held to maturity debt securities, loans, and other instruments, entities are required to use a new forward-looking “expected loss” model that generally will result in the earlier recognitiondate of allowances for losses. The Company adopted the guidance on January 1, 2020 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.issuance.

 

57 

 

 

Although there are several other new accounting pronouncements issued or proposed byIn connection with the FASB,Private Placement, we entered into a placement agent agreement with a placement agent (the “Placement Agent”) pursuant to which the Company Placement Agent is serving 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 fee 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 Private Placement, or 444,444 shares of our common stock (the “Placement Agent Warrant”). The Placement Agent Warrant, described in more detail in Note 10, “Warrants”, has adopted oran exercise price of $2.8125 per share, subject to customary anti-dilution, but not price protection, adjustments and will adopt, as applicable, the Company does not believe any of these accounting pronouncements has had or will have a material impactbe immediately exercisable and expire 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,liabilities; valuation allowances for trade receivables, inventory and deferred income tax assets and liabilities,liabilities; current and long-term lease obligations and corresponding right-of-use asset, evaluation of ability to continue as a going concernasset; and estimates for the fair value of long-term debt, stock optionsoption grants and other equity awards upon which the Company determines stock-based compensation expense. Actual results could differ from those estimates.

 

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 current global novel strain of coronavirus, or 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. No impairments of long-lived assets were recorded for the three and six months ended June 30, 2020March 31, 2021 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 current COVID-19 pandemic and its impact on the Company’s projected cash flows, the Company evaluated goodwill for impairment at the end of the second quarter of 2020. No impairments of goodwill were recorded for the three months ended March 31, 2021 and six months ended June 30, 2020 and 2019.2020.

 

Net 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 six months ended June 30,March 31, 2021 and 2020, and 2019, 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 6,691,07511,982,139 and 3,135,9734,363,089 outstanding stock options, restricted stock units and warrants for the three and six months ended June 30,March 31, 2021 and 2020, and 2019, respectively, are anti-dilutive.

 

Reclassification

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

68 

 

 

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 June 30, 2020 and December 31, 2019.rates.

 

(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 expect 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 our 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 six months ended June 30,March 31, 2021 and 2020 and 2019 (in thousands):

 

  

Three Months

Ended

  Percentage of  

Three Months

Ended

  Percentage of 
  June 30, 2020  Total Revenue  June 30, 2019  Total Revenue 
Orthobiologics $7,317   70% $11,020   72%
Spinal implant  3,176   30%  4,177   27%
Other revenue  36   0%  74   1%
Total revenue $10,529   100% $15,271   100%

  

Six Months

Ended

  Percentage of  

Six Months

Ended

  Percentage of 
  June 30, 2020  Total Revenue  June 30, 2019  Total Revenue 
Orthobiologics $18,071   72% $23,020   72%
Spinal implant  7,156   28%  8,863   27%
Other revenue  80   0%  114   1%
Total revenue $25,307   100% $31,997   100%

7

  Three Months
Ended
  Percentage of  Three Months
Ended
  Percentage of 
  March 31, 2021  Total Revenue  March 31, 2020  Total Revenue 
Orthobiologics $9,011   72% $10,755   73%
Spinal implant  3,498   28%  3,980   27%
Other revenue  33   0%  43   0%
Total revenue $12,542   100% $14,778   100%

 

(3)Receivables

 

Concurrent with the adoption of ASU 2016-13, theThe 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 June 30,March 31, 2021 and 2020 (in thousands):

 

Balance at January 1, 2020 $547 
 March 31, 2021  March 31, 2020 
Balance at January 1 $653  $547 
Provision for expected credit losses  138   (63)  138 
Write-offs charged against allowance  (17)  (36)  (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 
Balance at March 31 $554  $668 

 

(4)Inventories

 

Inventories consist of the following (in thousands):

 

 June 30, 2020  December 31, 2019  March 31, 2021  December 31, 2020 
Raw materials $4,383  $3,805  $3,758  $3,757 
Work in process  3,168   1,603   1,537   1,733 
Finished goods  23,727   22,135   16,346   15,918 
Gross inventories  31,278   27,543 
Reserve for obsolescence  (11,390)  (11,442)
Total $19,888  $16,101 
 $21,641  $21,408 

 

(5)Property and Equipment, Net

 

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

 

 June 30, 2020  December 31, 2019  March 31, 2021  December 31, 2020 
Equipment $4,516  $4,250  $5,217  $4,950 
Computer equipment  462   455   593   649 
Computer software  570   570   517   570 
Furniture and fixtures  133   124 
Leasehold improvements  3,987   3,980   3,987   3,987 
Vehicles  10   10 
Surgical instruments  11,118   10,897   11,621   11,291 
Total cost  20,796   20,286   21,935   21,447 
Less: accumulated depreciation  (16,540)  (15,591)  (17,269)  (17,100)
Property and equipment, net $4,256  $4,695  $4,666  $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. Asfirst three months of June 30,2021 and 2020 the Company has recorded $1.4was $0.4 million of gross assets in equipment and $1.1$0.7 million, of accumulated depreciation for assets subject to finance leases.respectively.

8

 

(6)Intangible Assets

 

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

 

 June 30, 2020  December 31, 2019  March 31, 2021  December 31, 2020 
Patents $847  $847  $847  $847 
Accumulated amortization  (361)  (332)  (404)  (390)
Intangible assets, net $486  $515  $443  $457 

The following is a summary of estimated future amortization expense for intangible assets as of March 31, 2021 (in thousands):

 Remainder of 2021  $41 
 2022   54 
 2023   53 
 2024   52 
 2025   52 
 Thereafter   191 
 Total  $443 

10 

 

(7)Accrued Liabilities

 

Accrued liabilities consist of the following (in thousands):

 

 June 30, 2020  December 31, 2019  March 31, 2021  December 31, 2020 
Wages/commissions payable $2,971  $3,902 
Cash compensation/commissions payable $3,183  $4,057 
Other accrued liabilities  2,923   2,723   1,386   1,405 
Accrued liabilities $5,894  $6,625  $4,569  $5,462 

 

(8)Debt

 

The Company has a credit facility with OrbiMed Royalty Opportunities II, LP (“Royalty Opportunities”) and ROS Acquisition Offshore LP (“ROS” and together with Royalty Opportunities the “Lenders”) (the “Second Amended and RestatedA&R Credit Agreement”). On May 6, 2020, the Company, entered into a First Amendment to the Second Amended and Restated Credit Agreement (the “First Amendment”) with the Lenders,, which among other things, provided that:

No interest will accruematures 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 Ron Berlin.

On May 6, 2020, Xtant issued warrants to purchase an aggregate of 2.4 million shares of Company common stock to the Lenders, with an exercise price of $0.01 per share and an expiration date of May 6, 2030 (collectively, the “2020 Warrants”). The issuance of the 2020 Warrants was a condition to 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%. The premium recorded as of June 30, 2020 will continue to increase until the Company makes cash interest payments beginning December 31, 2020.

2021. As of June 30, 2020, the Company had availability for additional delayed draw loan advances of $2.2 million, subject to Lenders’ discretion. In addition,March 31, 2021, the Company may request additional term loans from the LendersRoyalty Opportunities in an aggregate amount up to $10.0$5.0 million, subject to Lenders’Royalty Opportunities’ discretion.As a result of our most recent amendment to the Second A&R Credit Agreement, the carrying value of loans outstanding under the Second A&R Credit Agreement is equal to the undiscounted future cash payments associated with the Second Amendment and principal associated with loans thereunder. Cash interest payments in connection with the Second A&R Credit Agreement will reduce the carrying value of associated loans; and accordingly, no interest expense related to cash interest payments will be recorded for the duration of the Second A&R Credit Agreement.

9

 

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

 

  June 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  676   399 
Gross long-term debt  77,562   76,336 
Premium related to First Amendment  32    
Less: total debt issuance costs on Credit Agreements  (63)  (92)
Long-term debt, plus premium and less issuance costs $77,531  $76,244 

The Lenders, which collectively own approximately 70% of the Company’s outstanding common stock, and beneficially own, with their warrants, approximately 78% of the Company’s common stock, are the sole holders of the Company’s outstanding long-term debt. In addition, as described in more detail in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 filed with the Securities and Exchange Commission (the “SEC”) on March 5, 2020, the Company is a party to an Investor Rights Agreement and Registration Rights Agreement with the Lenders in addition to the Second Amended and Restated Credit Agreement.

  March 31, 2021  December 31, 2020 
Amounts due under the Second Amended and Restated Credit Agreement $15,556  $15,556 
Premium related to Second Amendment  934   1,241 
Less: current maturities  (16,490)  (16,797)
Long-term debt $  $ 

 

(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 sixthree months ended:ended March 31, 2021 and 2020:

 

  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  -  $-  $-   100,000  $2.24  $1.95 
Cancelled or expired  (120,738) $6.42  $4.05   (448,053) $4.64  $3.69 
Outstanding at June 30  482,228  $5.98  $3.98   148,905  $9.12  $6.53 
Exercisable at June 30  22,391  $70.63  $40.19   18,135  $52.04  $33.67 
  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 
Cancelled or expired  (125) $372.00  $184.59   (76,299) $4.18  $2.96 
Outstanding at March 31  2,190,767  $2.23  $1.64   526,667  $6.34  $4.14 
Exercisable at March 31  122,614  $14.38  $8.77   48,764  $41.11  $23.34 

11 

 

During the six months ended June 30, 2020, 489,437 restrictedRestricted stock units wereunit activity for awards granted under the 2018 Plan which vest over a weighted average period of 1.5 years. Total restricted stock units outstanding underwas as follows for the 2018 Plan were 927,548three months ended March 31, 2021 and 40,000 as of June 30, 2020 and 2019, respectively.2020:

  

2021

  2020 
  Shares  

Weighted Average Fair Value at Grant Date Per Share

  Shares  

Weighted Average Fair Value at Grant Date Per Share

 
Outstanding at January 1  2,503,698  $1.54   499,914  $2.93 
Granted  -  $-   489,437  $1.45 
Vested  (244,716) $1.45   (61,803) $2.27 
Outstanding at March 31  2,258,982  $1.54   927,548  $1.86 

 

(10)Warrants

 

2020 Warrants

As noted in Note 8,1, “Business 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.

10

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 allusing a Black Scholes model. Significant assumptions in both models included contractual term (5 years) and the requirements to be classified as equity awards in accordance with ASC No. 815-40. The numberestimated volatility factor based on a weighted average of sharescomparable published betas 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.peer companies (61%).

 

  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 June 30, 2020  5,261,162  $1.53 

Our warrant activity during the three months ended March 31, 2021 was as follows:

 

The estimated fair value of warrants issued was derived using a valuation model with the following weighted-average assumptions:

  Six Months Ended June 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%

   

Common Stock

Warrants

  Weighted Average Exercise Price 
 Outstanding at January 1, 2021   421,278  $10.80 
 Issued   7,111,112   2.29 
 Outstanding at March 31, 2021   7,532,390  $2.76 

 

(11)Commitments and Contingencies

 

Operating Leases

We lease three office facilities as of June 30, 2020March 31, 2021 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.

 

12 

Present Value of Long-term Leases

 

(in thousands): June 30, 2020  March 31, 2021 
Right-of-use assets, net $1,898  $1,585 
        
Current portion of lease liability  408   431 
Lease liability, less current portion  1,518   1,192 
Total lease liability $1,926  $1,623 

 

As of June 30, 2020,March 31, 2021, the weighted-average remaining lease term was 4.43.7 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, as of June 30, 2020, the Company estimates the weighted-average discount rate for its operating leases to be 5.2% of present value based on the incremental borrowing rate.

11

 

Future minimum payments for the next five years and thereafter as of June 30, 2020March 31, 2021 under these long-term operating leases are as follows (in thousands):

 

Remainder of 2020 $251 
2021  507 
Remainder of 2021 $380 
2022  521   521 
2023  489   489 
2024  224   224 
Thereafter  179 
2025  179 
Total future minimum lease payments  2,171   1,793 
Less amount representing interest  (245)  (170)
Present value of obligations under operating leases  1,926   1,623 
Less current portion  (408)  (431)
Long-term operating lease obligations $1,518  $1,192 

 

Rent expense was $0.1 million for the three months ended June 30, 2020March 31, 2021 and 2019 and $0.3 million for the six months ended June 30, 2020 and 2019.2020. We have no contingent rent agreements.

 

Financing Leases

Future minimum payments under finance leases are as follows as of June 30, 2020March 31, 2021 (in thousands):

 

Remainder of 2020 $102 
Less amount representing interest  (1)
Present value of obligations under financing leases $101 
Remainder of 2021 $28 
2022  37 
2023  37 
2024  37 
2025  37 
Thereafter  3 
Total future minimum lease payments  179 
Less amount representing interest  (20)
Present value of obligations under finance leases  159 
Less current portion  (30)
Long-term operating lease obligations $129 

 

13 

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 claiming that some of our products, including the Irix-A Lumbar Integrated FusionButrex Plating System, Spider Plating System, Aranax Plating System and the Irix-C Cervical IntegratedIrix Fusion System, infringe certain of RSB Spine’s patents. On February 28, 2020, we entered into a confidentialpatent held by the third party and offering to discuss settlement terms. Because this matter is in early stages and patent license agreement with RSB Spine pursuant to which we agreed to make an undisclosed settlement payment to RSB Spine and pay royalties on future salesbecause of the two products through the expirationcomplexity of the asserted patents. The settlement payment was includedclaims, we cannot estimate the possible loss or range of loss, if any, associated with its resolution. However, there can be no assurance that the ultimate resolution of this matter will not result in accrued expenses asa material adverse effect on our business, financial condition or results of December 31, 2019.operations.

 

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.

12

 

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 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 six months ended June 30, 2020March 31, 2021 and 2019.2020.

14 

 

(13)Supplemental Disclosure of Cash Flow Information

 

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

 

 Six Months Ended  Three Months Ended 
 June,  March 31, 
 2020  2019  2021  2020 
Supplemental disclosure of cash flow information             
Cash paid during the period for:             
Interest $12  $47  $1  $7 
Non-cash activities:                
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  $  $  $47 
Recognition of 2020 Warrants $1,862  $ 
Lease liability from right-of-use assets $  $2,658 
Extinguishment of the Company’s prior credit agreement (including debt issuance costs) $  $307 
Recognition of Second Amended and Restated Credit Agreement $  $72,657 
Recognition of 2019 Warrants $  $9 

 

(14)Related Party Transactions

 

Royalty Opportunities, and ROS collectively ownwhich owns approximately 70%20% of the Company’s outstanding common stock, and arewas the sole holdersholder of our outstanding long-term debt and are Lenders undera party to the Second A&RAmended and Restated Credit Agreement. Agreement, which was terminated in connection with our debt refinancing described under Note 16. 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, 2019,2020, we are party to an Investor Rights Agreement, and Registration Rights AgreementAgreements and certain other agreements with Royalty Opportunities and ROS. Transactions between the Company, on the one hand, and Royalty Opportunities and ROS on the other hand,Acquisition Offshore LP (“ROS”), which are conducted under the provisionsfunds affiliated with OrbiMed Advisors LLC (“OrbiMed”). OrbiMed beneficially owns 84% of the Second Amended and Restated Credit Agreement, the Company’s prior Credit Agreement, the Investor Rights Agreement, and the Registration Rights Agreement, as previously noted.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.

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(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% and 96% of sales were in the United States for the threenine months ended June 30,March 31, 2021 and 2020, and 2019, respectively, and 97% and 96% for the six months ended June 30, 2020 and 2019, respectively. Total revenue by major geographic area is as follows (in thousands):

 

 

Three Months Ended

June 30,

  Three Months Ended
March 31,
 
 2020  2019  2021  2020 
United States $10,313  $14,585  $12,293  $14,251 
Rest of world  216   686   249   526 
Total revenue $10,529  $15,271  $12,542  $14,777 

 

  

Six Months Ended

June 30,

 
  2020  2019 
United States $24,565  $30,702 
Rest of world  742   1,295 
Total revenue $25,307  $31,997 

(16) Subsequent Event

On May 6, 2021 (the “Closing Date”), the Company, as guarantor, and its subsidiaries, as borrowers (collectively, the “Borrowers”), entered into a (i) Credit, Security and Guaranty Agreement (Term Loan) (the “Term Credit Agreement”) with MidCap Financial Trust, in its capacity as agent (the “Agent”), and a lender and the additional lenders from time to time party thereto and (ii) Credit, Security and Guaranty Agreement (Revolving Loan) (the “Revolving Credit Agreement,”, and, together with the Term Credit Agreement, the “Credit Agreements”), with the Agent and the lenders from time to time party thereto.

 

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The Term Credit Agreement provides for a secured term loan facility (the “Term Facility”) in an aggregate principal amount of $12,000,000 (the “Term Loan Commitment”), which was funded to the Borrowers on the Closing Date, and an additional $5,000,000 tranche available solely at the discretion of the Agent 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 “Revolving Facility,”, and, together with the Term Facility, the “Facilities”) under which the Borrowers may borrow up to $8,000,000 (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 loans and other obligations pursuant to the Credit Agreements will 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 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 Second Amended and Restated Credit Agreement. 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.

The Credit Agreements replaced the Company’s Second Amended and Restated Credit Agreement and the indebtedness incurred, and all other obligations of the Company and its subsidiaries owed, under the Second Amended and Restated Credit Agreement were repaid in full and terminated using proceeds of the loans received under the Credit Agreements.

1416 

 

 

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

Executive SummaryBusiness 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.

 

AsWe have an extensive sales channel of June 30, 2020, our cashindependent commissioned agents and cash equivalents were $3.0 million. On March 29, 2019, we entered into a Second Amended and Restated Credit Agreement (“Second Amended and Restated Credit Agreement”), which amended and restated our prior credit agreement, as amended (“Prior Credit Agreement”), revised certain covenants and increased our credit availability by $10.0 million, subject tostocking distributors in the discretionUnited States representing some or all of our lenders. On May 6, 2020, we entered intoproducts. We also maintain a First Amendmentnational accounts program to the Second Amendedenable our agents to gain access to integrated delivery network hospitals (“IDNs”) and Restated Credit Agreementthrough group purchasing organizations (“First Amendment”GPOs”), which amended the Second Amended and Restated Credit Agreement to extend the period over which interest does not accrue, extend the maturity and revise certain covenants. As of June 30, 2020, we had availability of $12.2 million under our credit facility, subject to the discretion of our lenders. We believe that cash and cash equivalents, together with the availability under the Second Amended and Restated Credit Agreement, will be sufficient to meet our anticipated cash requirements for at least the next 12 months.

On April 4, 2019, we received a letter from NYSE Regulation notifying us that we are not in compliance with the NYSE American’s continued listing standards relating to stockholders’ equity. Specifically, we are not in compliance with Section 1003(a)(i) of the NYSE American Company Guide (“Company Guide”) with stockholders’ equity of less than $2.0 million and net losses in two of the three most recent fiscal years, Section 1003(a)(ii) with stockholders’ equity of less than $4.0 million and net losses in three of the four most recent fiscal years, and Section 1003(a)(iii) with stockholders’ equity of less than $6.0 million and net losses in the five most recent fiscal years. Therefore, we became subject to the procedures and requirements of Section 1009 of the Company Guide. On May 3, 2019, we submitted a plan of compliance to NYSE Regulation addressing how we intend to regain compliance with Sections 1003(a)(i), 1003(a)(ii), and 1003(a)(iii) or meet the exemption in Section 1003(a) of the Company Guide by October 4, 2020. On May 23, 2019, we received a letter from NYSE Regulation stating that the Company’s plan of compliance has been accepted and the Company has been granted a plan period through October 4, 2020.. We have been advised thatbiologics 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 will be subject to delisting proceedings if we do not regain compliance prior to October 4, 2020 or if NYSE Regulation determines that we are not making progress consistent withpromote and sell our plan of compliance. Our common stock will continue to trade on the NYSE American under the symbol “XTNT,” with the added designation of “.BC” to indicate that we are notproducts internationally through stocking distribution partners in compliance with the continued listing standards.Canada, Mexico, South America, Australia, and certain Pacific region countries.

 

Recent Private Placement

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 warrants to purchase up to 6,666,668 shares of our common stock. These warrants have an exercise price of $2.25 per share, subject to customary anti-dilution, but not price protection, adjustments, and are immediately exercisable and expire on the five-year anniversary of the date of issuance. We received net cash 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.

Potential Impact of the COVID-19 Pandemic

 

The globalSince March 2020, the COVID-19 pandemic has led to the closure of businesses,caused business closures, severe travel restrictions and the implementation of social distancing measures. HospitalsAt the onset of the COVID-19 pandemic, hospitals and other medical facilities have canceledcancelled or deferred elective surgeries, reduced and diverted staffing andprocedures, 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, surgeons and their patients arehave been, and may continue to be, required, or are choosing, to defer procedures in which our products otherwise would be used, and many facilities that specialize in the procedures in which our products otherwise would be used have closedexperienced temporary closures or reduced operating hours. These circumstances have negatively impacted, and may continue to negatively impact, the ability of our employees, independent sales representatives and distributors to effectively market and sell our products, which has had a material adverse effect on our revenues and despite the recent easing of such restrictions in many locations will likely continue to have a material adverse effect on our revenues. In addition, even after the easing of such restrictions such that governmental orders no longer prohibit or recommend against performing such procedures, patients may continue to defer such procedures out of concern of being exposed to coronavirus or for other reasons. It is uncertain if our revenues will ever return to pre-COVID-19 levels.

 

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The COVID-19 pandemic 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, eachany 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, andlong-term. This 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 disruptions in their business. This could impact our ability to manufacture 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.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.

15

In response to 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 terminated the temporary 20% base salary and wage reductions and reinstituted the full base salaries and wages of all our employees.

 

COVID-19 has resulted and will likely continue to result in a material adverse effect on our business, operating results, financial condition, prospects and the trading price of our common stock in the near-term and beyond 2020.near-term. 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, and the actions to contain it or treat its impact.impact, and the availability and effectiveness of vaccines.

 

Results of Operations

 

Comparison of Three and Six Months Ended June 30,March 31, 2021 and March 31, 2020 and June 30, 2019

Revenue

Total revenue for the three and six months ended June 30, 2020March 31, 2021 was $10.5$12.5 million, and $25.3 million, respectively, which represents a decrease of 31.1% and 20.9%, respectively,15.1% compared to $15.3$14.8 million and $32.0 million forin the three and six months ended June 30, 2019, respectively.same quarter of the prior year. The decrease in revenue is largely attributed primarily to the impact of COVID-19 andon the sudden drop inoccurrence of elective procedures beginning in early March 2020 as a result of the COVID-19 pandemic.procedures.

 

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 decreased by 25.8%13.8%, or $1.4$0.7 million, to $4.0$4.5 million for the three months ended June 30, 2020March 31, 2021 from $5.4$5.2 million for the three months ended June 30, 2019. Cost of sales decreased by 18.9%, or $2.1 million, to $9.1 million for the six months ended June 30, 2020 from $11.3 million for the six months ended June 30, 2019.March 31, 2020. The reduction in cost of sales is primarily due to lower revenue duringin the three and six months ended June 30, 2020first quarter of 2021 versus the comparable periods in 2019,first quarter of 2020, as mentioned above.

 

Gross profit as a percentage of salesrevenue decreased to 62.2%64.5% for the three months ended June 30, 2020March 31, 2021 compared to 64.9%65.0% for the same period in 2019. Gross profit as a percentage of sales decreased to 63.9% for the six months ended June 30, 2020 compared to 64.8% for the same period in 2019.2020. The reductionsreduction during the three and six months ended June 30, 2020March 31, 2021 compared to the same period in the prior year areis primarily attributable to diminished economies of scale.scale, partially offset by reduced depreciation expense.

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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 30.0%29.9%, or $1.3 million, to $2.9$3.0 million for the three months ended June 30, 2020,March 31, 2021, compared to $4.2$4.3 million for the same period in 2019. General and administrative expenses decreased 16.3%, or $1.4 million, to $7.3 million for the six months ended June 30, 2020, compared to $8.7 million for the same period in 2019. The2020. This decrease for the three-month comparison is primarily attributable to lower legal and consulting fees of $0.6 million, reduced executive recruiting fees of $0.4 million, reduced legal settlementseverance related expenses of $0.3totaling $0.7 million and reduced salaries and wagescosts related to enterprise resource planning system upgrades of $0.3 million during the three months ended June 30, 2020. This decrease was offset partially by additional stock-based compensation expense of $0.2 million during the three months ended June 30, 2020. The decrease for the six-month comparison is primarily attributable to lower legal and consulting fees of $1.1 million, reduced legal settlement expenses of $0.8 million, reduced executive recruiting fees of $0.4 million, reduced salaries and wages of $0.2 million, and reduced license fees of $0.2 million during the six months ended June 30, 2020. This decrease was offset partially by severance expense of $0.8 million and additional stock-based compensation expenseprior year period as well as reductions of $0.3 million duringin expenses related to licensing and fees in the six months ended June 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 secondfirst 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 35.9%24.3%, or $2.2$1.6 million, to $3.9$4.9 million for the three months ended June 30, 2020,March 31, 2021, compared to $6.1$6.4 million for the same period of 2019. Sales and marketing expenses decreased 19.5%, or $2.5 million, to $10.3 million for the six months ended June 30, 2020, compared to $12.8 million for the same period of 2019. The2020. This decrease for the three-month comparison is primarily due to thea reduction in sales commissions of $1.5$0.9 million due to lower revenues versus the comparable period in 2019 andyear over year and reduced salaries and wages of $0.4 million due to thea reduction in headcount. As a percentage of revenue, sales and marketing expenses decreased to 38.8% in the temporary 20% salary and wage decreases implemented during the second quarter of 2020three months ended March 31, 2021 from 43.4% in response to the COVID-19 pandemic. The decrease for the six-month comparison is primarily due to the reduction in sales commissions of $1.9 million due to lower revenues versus the comparable period in 2019 andthe prior year due primarily to reduced salaries and wages of $0.4 million.headcount.

 

Research and Development

 

Research and development expenses consist primarily of internal costs for the development of new technologies and processes. Research and development expenses decreased 47.1%, or $0.1 million, to $0.1 million for the three months ended June 30, 2020, compared toof $0.2 million for the three months ended June 30, 2019. Research and development expenses decreased 25.2%, or $0.1 million, to $0.4 million for the six months ended June 30, 2020, compared to $0.5 million for the six months ended June 30, 2019. The reduction in research and development expenses is primarily due to reduced salaries and wages during the three and six months ended June 30, 2020 comparedMarch 31, 2021 were comparable to the prior year periods.same period in 2020.

 

Interest Expense

Interest expense is related to interest incurred from our debt instruments. Interestinstruments and finance leases. The Company no longer incurs interest expense was $2.1related to the Second A&R Credit Agreement as cash interest payments made subsequent to our latest amendment to the Second A&R Credit Agreement are treated as reduction of the loan’s carrying value. The elimination of interest expense related to the most recent amendment resulted in a $1.1 million for the three months ended June 30, 2020 compared to $1.3 million for the three months ended June 30, 2020. Interest expense was $3.2 million for the six months ended June 30, 2020 and $3.3 million for the six months ended June 30, 2019. The increasereduction in interest expense during the three months ended June 30, 2020 resulted from additional interest associated withMarch 31, 2021 compared to the First Amendment. Interest expense during the sixthree months ended June 30,March 31, 2020. We anticipate increased interest expense in future periods, as compared to prior periods subsequent to October 1, 2020, was comparable to the prior year period.as a result of our new credit facilities discussed below.

17

 

Liquidity and Capital Resources

Working Capital

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

 

 

June 30, 2020

  December 31, 2019  March 31, 2021  December 31, 2020 
Cash and cash equivalents $3,019  $5,237  $18,643  $2,341 
Accounts receivable, net  7,583   10,124   7,027   6,880 
Inventories  19,888   16,101   21,641   21,408 
Total current assets  31,389   32,246   48,476   31,365 
Accounts payable  3,072   2,188   2,490   2,947 
Accrued liabilities  5,894   6,632   4,569   5,462 
Current portion of long-term debt  16,490   16,797 
Total current liabilities  9,475   9,390   24,010   25,649 
Total working capital  21,914   22,856  $24,466  $5,716 
Long-term debt, less issuance costs  77,531   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 warrants to purchase up to 6,666,668 shares of our common stock. These warrants have an exercise price of $2.25 per share, subject to customary anti-dilution, but not price protection, adjustments, and are immediately exercisable and expire on the five-year anniversary of the date of issuance. We received net proceeds of approximately $18.5 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.

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Cash Flows

Net cash used in operating activities for the first sixthree months of 20202021 was $1.6$1.3 million attributed to the increasea reduction in inventories of $4.2 million and the reduction of accrued liabilities of $0.7 million, offset partially by the decrease in accounts receivable of $2.3$0.9 million and increasea reduction in accounts payable of $0.9of $0.5 million. For the comparable period of 2019,2020, net cash provided byused in operating activities was $1.0$1.8 million.

 

Net cash used in investing activities for the first sixthree months of 2021 and 2020 and 2019 was $0.6$0.5 million and $48 thousand,$0.2 million, respectively, primarily representing purchases of property and equipment.

 

Net cash provided by financing activities for the first three months of 2021 was $18.1 million, consisting primarily of net cash proceeds from our private placement of $18.4 million, partially offset by payments on long-term debt of $0.3 million. For the comparable period of 2020, net cash used in financing activities was $0.1 million and $0.4 million for the first six months of 2020 and 2019, respectively, primarily representing payments for financing leases.$34 thousand.

 

Current and Prior Credit FacilityFacilities

On March 29, 2019, weMay 6, 2021 (the “Closing Date”), the Company, as guarantor, and its subsidiaries, as borrowers (collectively, the “Borrowers”), entered into a (i) Credit, Security and Guaranty Agreement (Term Loan) (the “Term Credit Agreement”) with MidCap Financial Trust, in its capacity as agent (the “Agent”) and a lender and the additional lenders from time to time party thereto and (ii) Credit, Security and Guaranty Agreement (Revolving Loan) (the “Revolving Credit Agreement,” and, together with the Term Credit Agreement, the “Credit Agreements”), with the Agent and the lenders from time to time party thereto.

The Term Credit Agreement provides for a secured term loan facility (the “Term Facility”) in an aggregate principal amount of $12,000,000 (the “Term Loan Commitment”), which was funded to the Borrowers on the Closing Date, and an additional $5,000,000 tranche available solely at the discretion of the Agent 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 “Revolving Facility,” and, together with the Term Facility, the “Facilities”) under which the Borrowers may borrow up to $8,000,000 (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. Each of the Borrowers, and the 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.

The loans and other obligations pursuant to the Credit Agreements will 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%.

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The Credit Agreements contain affirmative and negative covenants customarily 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 minimum liquidity, in each case at levels specified in 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, as subsequently amended (the “Second A&R Credit Agreement”), which was scheduled to mature on December 31, 2021, was terminated in accordance with the Lenders, which amendedterms thereof and restatedall outstanding amounts were repaid by the Prior Credit Agreement. TheBorrowers to Royalty Opportunities in its role as sole lender thereunder. Interest on outstanding borrowings under the Second Amended and RestatedA&R Credit Agreement amended the Prior Credit Agreement to provide that we may request term loans from the Lenderswas payable in their sole discretion in an amount equal tocash for the remaining availability for additional delayed draw loans, which was approximately $2.2 million as of the dateterm of the Second Amended and RestatedA&R Credit Agreement and request additional term loans from the Lenders in their sole discretion in an aggregate amount of up to $10.0 million, the amount of each loan draw to be also subject to our production of a thirteen-week cash flow forecast that is approved by the Lenders and which shows a projected cash balance for the following two-week period of less than $1.5 million, as well as the satisfaction (or waiver in writing by each Lender) of conditions precedent, including closing certificate, delivery of a budget, and other satisfactory documents. In addition, the Second Amended and Restated Credit Agreement provides that (i) no interest will accrue on the loans thereunder from and after January 1, 2019 until March 31, 2020; (ii) beginning April 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 (a) 10.00%(i) 7.00% plus (b)(ii) the higher of (x) the LIBO Rate (as such term is defined in the Second Amended and RestatedA&R Credit Agreement) and (y) 2.3125%; (iii) the maturity date1.00%. As of the loans thereunder is March 31, 2021; (iv) the Consolidated Senior Leverage Ratio and Consolidated EBITDA (as such terms were defined in the Prior Credit Agreement) financial covenants were deleted and a new Revenue Base (as such term is defined 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.

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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 Ron Berlin.

As of June 30, 2020,2021, we were in compliance with all covenants under the Second Amended and RestatedA&R Credit Agreement as amended by the First Amendment..

 

Cash Requirements

We believe that our June 30, 2020$18.6 million of cash and cash equivalents as of $3.0 million,March 31, 2021, together with the availability of $12.2 millionamounts available under the Second Amended and Restated Credit Agreement as of such date,Facilities, will be sufficient to meet our anticipated cash requirements forthrough at least the next 12 months.May 2022. However, we may require or seek additional fundscapital to fund our future operations and business strategy.strategy prior to May 2022. Accordingly, there is no assurance that we will not need or seek additional fundingfinancing prior to such time.

We may elect to raise additional fundsfinancing even before we need themit if market conditions for raising additional capital are favorable. We may seek to raise additional fundsfinancing through various sources, such as 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 secure additional sources of funds to support our operations, or if such funds 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,ROS Acquisition Offshore LP (“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.

 

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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 six months ended June 30, 2020March 31, 2021 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 RISKQuantitative 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 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 ActAct) as of June 30, 2020.March 31, 2021. Based upon that evaluation, our principal executive officer and principal financial officer concluded that as of June 30, 2020,March 31, 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 June 30, 2020,March 31, 2021, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

PART II. OTHER INFORMATION

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PART II.OTHER INFORMATION

ITEM 1.Legal Proceedings

 

WeOur legal proceedings are subject to potential liabilities under government regulationsdiscussed in Note 11 – Commitments and various claims and legal actions that are pending or may be asserted from time to time. These matters ariseContingencies in the ordinary course and conduct ofnotes to our business and may include, for example, commercial, product liability, intellectual property, and employment matters. We intend to continue to defend the Company vigorouslycondensed consolidated financial statements in such matters and when warranted, take legal action against others.this Form 10-Q.

 

Item 1A.Risk Factors

 

Although Item 1A is inapplicable to Xtant asAs a smaller reporting company, we hereby discloseare not required to provide the following additional risk:information required by this Item.

 

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The Company’s 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) pandemic.

The global COVID-19 pandemic has led to the closure of businesses, severe travel restrictions and social distancing. Hospitals and other medical facilities have canceled elective surgeries, reduced and diverted staffing and diverted resources to patients suffering from the infectious disease and limited hospital access for non-patients, including our direct and indirect sales representatives. Because of the COVID-19 pandemic, surgeons and their patients are required, or are choosing, to defer procedures in which our products otherwise would be used, and many facilities that specialize in the procedures in which our products otherwise would be used have closed or reduced operating hours. These circumstances have negatively impacted 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 the pandemic has subsided and/or governmental orders no longer prohibit or recommend against performing such procedures, patients may continue to defer such procedures out of concern of being exposed to coronavirus or for other reasons.

The COVID-19 pandemic 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, each 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, as a result of this negative effect 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 be 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 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 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 in the near-term and beyond 2020. The full extent to which the COVID-19 pandemic will 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 and the actions to contain it or treat its impact. The COVID-19 pandemic also heightens the risks in certain of the other risk factors described in our Annual Report Form 10-K for the year ended December 31, 2019.

ITEM 2.Unregistered Sales of Equity Securities and Use of Proceeds

 

Not applicable.We did not sell any unregistered equity securities of our Company during the quarter ended March 31, 2021, other than the issuance of shares of our common stock and warrants in connection with our private placement, as reported in a Current Report on Form 8-K as filed with the SEC on February 22, 2021.

 

ITEM 3.Defaults Upon Senior Securities

 

Not applicable.

 

ITEM 4.Mine Safety Disclosures

 

Not applicable.

 

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ITEM 5.Other Information

 

2020 Bonus Plan

On July 29, 2020, the Board of Directors of the Company (the “Board”), upon recommendation of the Compensation Committee, formally approved the material terms of a discretionary bonus plan for 2020 applicable to the Company’s executive officers and certain other participants, which annual bonuses are tied closely to the Company’s financial performance for the fiscal year ended December 31, 2020 (the “2020 Bonus Plan”). Under the 2020 Bonus Plan, each participant will be eligible to earn a discretionary annual bonus based on the Company’s achievement in 2020 of performance goals relating to total revenue, adjusted EBITDA (earnings before interest, taxes, depreciation and amortization, as adjusted for certain non-recurring items), certain predefined individual goals and Board discretion. The performance goals will be weighted as follows for the Company’s executive officers:Not applicable.

 

Performance CriteriaWeighting
Total revenue32%
Adjusted EBITDA13%
Individual goals30%
Board discretion25%

The table below sets forth the target annual bonus opportunity, expressed as a percentage of annual base salary, for each executive.

 

Executive and Position

 Target Annual Bonus Opportunity 2020 Base Salary 
Sean E. Browne
President and Chief Executive Officer
 $600,000
(100% of Base Salary)
 $600,000 
       
Greg Jensen
Vice President, Finance and Chief Financial Officer
 $200,000
(50% of Base Salary)
 $400,000 
       
Kevin D. Brandt
Chief Commercial Officer
 $207,500
(50% of Base Salary)
 $415,000 

The determination of bonuses under the 2020 Bonus Plan will be in the sole discretion of the Board or the Compensation Committee and, unless otherwise agreed upon by the Company in writing, will only be paid to a participant if he or she remains an employee of the Company or one of its subsidiaries on the payment date, which payment date will be determined by the Board or the Compensation Committee at a later date and is contemplated to be after the issuance of the Company’s financial statements for 2020.

Reinstatement of Executive Officer Base Salaries

In response to the COVID-19 pandemic, during the second quarter of 2020, the Company implemented a series of cost-savings actions intended to preserve capital to support our operations, including the institution of a temporary 20% base salary reduction for all executive officers. On July 27, 2020, the Board, upon recommendation of the Compensation Committee, approved the termination of the 20% temporary base salary reductions and the reinstatement of full base salaries for all executive officers, retroactive to July 1, 2020.

2020 Annual Meeting of Stockholders

On July 29, 2020, the Board established Tuesday, October 27, 2020 as the date of the Company’s 2020 annual meeting of stockholders (the “2020 Annual Meeting”). Although it is anticipated that the 2020 Annual Meeting will be held at 9:00 a.m., local time, at the offices of Fox Rothschild LLP in New York City, the exact time and location of the 2020 Annual Meeting will be specified in the Company’s proxy statement for the 2020 Annual Meeting.

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ITEM 6.Exhibits

 

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

 

Exhibit No. Description
3.1 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 February 13, 2018 (SEC File No. 0-34941)001-34951) and incorporated by reference herein).
   
3.2 Certificate 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. 0-34941)001-34951) and incorporated by reference herein).
   
3.3 Second 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. 0-34941)001-34951) and incorporated by reference herein).
   
4.1 Warrant dated asForm of May 6, 2020 issued by Xtant Medical Holdings, Inc. to ROS Acquisition Offshore LPInvestor Warrant (filed as Exhibit 4.1 to the Registrant’s QuarterlyCurrent Report on Form 10-Q for8-K filed with the quarterly period ended March 31, 2020SEC on February 22, 2021 (SEC File No. 0-34941)001-34951) and incorporated by reference herein).
   
4.2 Warrant dated asForm of May 6, 2020 issued by Xtant Medical Holdings, Inc. to OrbiMed Royalty Opportunities II, LPPlacement Agent Warrant (filed as Exhibit 4.2 to the Registrant’s QuarterlyCurrent Report on Form 10-Q for8-K filed with the quarterly period ended March 31, 2020SEC on February 22, 2021 (SEC File No. 0-34941)001-34951) and incorporated by reference)reference herein).
4.3Registration Rights Agreement, dated February 24, 2021, by and between Xtant Medical Holdings, Inc. and the investor party thereto (filed as Exhibit 4.4 to the Registrant’s Registration Statement on Form S-3 filed with the SEC on April 6, 2021 (Sec File No. 333-255074) and incorporated by reference herein).
   
10.1 First Amendment to Second AmendedSecurities Purchase Agreement, dated February 22, 2021, by and Restated Credit Agreement effective as of April 1, 2020 amongbetween Xtant Medical Holdings, Inc., Bacterin International, Inc., Xtant Medical, Inc., X-spine Systems, Inc., OrbiMed Royalty Opportunities II, LP and ROS Acquisition Offshore LPthe investor party thereto (filed as Exhibit 10.1 to the Registrant’s QuarterlyCurrent Report on Form 10-Q for8-K filed with the quarterly period ended March 31, 2020SEC on February 22, 2021 (SEC File No. 0-34941)001-34951) and incorporated by reference)reference herein).
10.2Placement Agent Agreement, dated February 22, 2021, by and between Xtant Medical Holdings, Inc. and A.G.P./Alliance Global Partners (filed as Exhibit 10.3 to the Registrant’s Current Report on Form 8-K filed with the SEC on February 22, 2021 (SEC File No. 001-34951) and incorporated by reference herein).
   
31.1 Certification 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).
   
31.2 Certification 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).
   
32.1 Certification 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).
   
32.2 Certification 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).
   
101 The following materials from Xtant’s Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2020,March 31, 2021, formatted in 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).

 

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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: August 3, 2020May 11, 2021By:/s/ Sean E. Browne
 Name:Sean E. Browne
 Title:President and Chief Executive Officer
  (Principal Executive Officer)

 

Date: August 3, 2020May 11, 2021By:/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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