UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM
10-Q

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended SeptemberJune 30, 2020

2021

or

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Commission File
Number 001-37906

ORGANOGENESIS HOLDINGS INC.

(Exact name of registrant as specified in its charter)

Delaware
 
98-1329150

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

85 Dan Road

Canton, MA 02021

(Address of principal executive offices) (Zip Code)

(781)
575-0775

(Registrant’s telephone number, including area code)

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange

on which registered

Class A Common Stock, $0.0001 par value
 
ORGO
 
Nasdaq Capital Market

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

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  ☒    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  ☒    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   Smaller reporting company 
 
  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  ☒

As of NovemberAugust 1, 2020,2021, the registrant had a total of 107,785,526128,583,801 shares of its Class A common stock, $0.0001 par value per share, outstanding.


Table of Contents

Organogenesis Holdings Inc.

Quarterly Report on Form
10-Q

For the Quarterly Period Ended SeptemberJune 30, 2020

2021

Table of Contents

   
Page
 

   4 
Item 1.    4 
    4 
    5 
    6 
    7 
    8 

Item 2.

 

   25 

Item 3.

 

   36 

Item 4.

 

   3736 

   38 
Item 1.    38 
Item 1A    3938 
Item 2.    4139 
Item 3.    4139 
Item 4.    4139 
Item 5.    4139 
Item 6.    4240 
   4341 

2

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on
Form 10-Q
contains forward-looking statements. These statements may relate to, but are not limited to, expectations of our future results of operations, business strategies and operations, financing plans, potential growth opportunities, potential market opportunities and the effects of competition, as well as assumptions relating to the foregoing. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. These risks and other factors include, but are not limited to, those listed under “Risk Factors.” In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “intend,” “potential,” “might,” “would,” “continue” or the negative of these terms or other comparable terminology. These forward-looking statements are based on our management’s current expectations, estimates, forecasts and projections about our business and the industry in which we operate and our management’s beliefs and assumptions. These forward-looking statements are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors that are in some cases beyond our control. As a result, any or all of our forward-looking statements in this Form
10-Q
may turn out to be inaccurate. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under “Risk Factors” and discussed elsewhere in this Form
10-Q including those related to
and in “Part I, Item 1A—Risk Factors” in our Annual Report on Form
10-K
for the coronavirus (COVID-19) pandemic.year ended December 31, 2020. These forward-looking statements speak only as of the date of this Form
10-Q.
Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future. You should, however, review the factors and risks we describe in the reports we will file from time to time with the SEC after the date of this
Form 10-Q.

As used herein, except as otherwise indicated by context, references to “we,” “us,” “our,” “the Company,” “Organogenesis” and “ORGO” will refer to Organogenesis Holdings Inc. and its subsidiaries.

3

PART I—FINANCIAL INFORMATION

Item 1. Unaudited Consolidated Financial Statements.

ORGANOGENESIS HOLDINGS INC.

CONSOLIDATED BALANCE SHEETS

(unaudited)

(amounts in thousands, except share and per share data)

   September 30,  December 31, 
   2020  2019 

Assets

   

Current assets:

   

Cash

  $36,512  $60,174 

Restricted cash

   374   196 

Accounts receivable, net

   56,915   39,359 

Inventory

   29,882   22,918 

Prepaid expenses and other current assets

   5,327   2,953 
  

 

 

  

 

 

 

Total current assets

   129,010   125,600 

Property and equipment, net

   55,937   47,184 

Notes receivable from related parties

   —     556 

Intangible assets, net

   31,849   20,797 

Goodwill

   28,916   25,539 

Deferred tax asset, net

   16   127 

Other assets

   700   884 
  

 

 

  

 

 

 

Total assets

  $246,428  $220,687 
  

 

 

  

 

 

 

Liabilities and Stockholders’ Equity

   

Current liabilities:

   

Deferred acquisition consideration

  $966  $5,000 

Current portion of term loan

   11,667   —   

Current portion of capital lease obligations

   3,473   3,057 

Accounts payable

   24,007   28,387 

Accrued expenses and other current liabilities

   26,132   23,450 
  

 

 

  

 

 

 

Total current liabilities

   66,245   59,894 

Line of credit

   39,353   33,484 

Term loan, net of current portion

   47,999   49,634 

Deferred acquisition consideration, net of current portion

   1,436   —   

Earnout liability

   3,782   —   

Deferred rent

   1,098   1,012 

Capital lease obligations, net of current portion

   12,239   14,431 

Other liabilities

   8,802   6,649 
  

 

 

  

 

 

 

Total liabilities

   180,954   165,104 
  

 

 

  

 

 

 

Commitments and contingencies (Note 13)

   

Stockholders’ equity:

   

Common stock, $0.0001 par value; 400,000,000 shares authorized; 108,185,702 and 105,599,434 shares issued; 107,457,154 and 104,870,886 shares outstanding at September 30, 2020 and December 31, 2019, respectively.

   11   10 

Additional paid-in capital

   237,015   226,580 

Accumulated deficit

   (171,552  (171,007
  

 

 

  

 

 

 

Total stockholders’ equity

   65,474   55,583 
  

 

 

  

 

 

 

Total liabilities and stockholders’ equity

  $246,428  $220,687 
  

 

 

  

 

 

 

   
June 30,
  
December 31,
 
   
2021
  
2020
 
Assets
         
Current assets:
         
Cash
  $89,790  $84,394 
Restricted cash
   517   412 
Accounts receivable, net
   76,767   56,804 
Inventory
   28,106   27,799 
Prepaid expenses and other current assets
   6,583   4,935 
   
 
 
  
 
 
 
Total current assets
   201,763   174,344 
Property and equipment, net
   69,739   60,068 
Intangible assets, net
   28,136   30,622 
Goodwill
   28,772   28,772 
Operating lease
right-of-use
assets, net
   26,531   —   
Deferred tax asset, net
   18   18 
Other assets
   605   670 
   
 
 
  
 
 
 
Total assets
  $355,564  $294,494 
   
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
Liabilities and Stockholders’ Equity
         
Current liabilities:
         
Deferred acquisition consideration
  $  $483 
Current portion of term loan
   22,500   16,666 
Current portion of finance lease obligations
   4,134   3,619 
Current portion of operating lease obligations
   4,504   —   
Current portion of deferred rent and lease incentive obligation
   —     95 
Accounts payable
   26,789   23,381 
Accrued expenses and other current liabilities
   26,618   23,973 
   
 
 
  
 
 
 
Total current liabilities
   84,545   68,217 
Line of credit
   10,000   10,000 
Term loan, net of current portion
   37,290   43,044 
Deferred acquisition consideration, net of current portion
   1,436   1,436 
Earnout liability
   927   3,985 
Deferred rent and lease incentive obligation, net of current portion
   —     2,315 
Finance lease obligations, net of current portion
   9,553   11,442 
Operating lease obligations, net of current portion
   24,224   —   
Other liabilities
   8,667   7,971 
   
 
 
  
 
 
 
Total liabilities
   176,642   148,410 
   
 
 
  
 
 
 
Commitments and contingencies (Note 18)
       
Stockholders’ equity:
         
Preferred stock, $0.0001 par value; 1,000,000 shares authorized; 0ne issued
   0—     0—   
Common stock, $0.0001 par value; 400,000,000 shares authorized; 129,011,789 and 128,460,381 shares issued; 128,283,241 and 127,731,833 shares outstanding at June 30, 2021 and December 31, 2020, respectively.
   13   13 
Additional
paid-in
capital
   299,038   296,830 
Accumulated deficit
   (120,129  (150,759
   
 
 
  
 
 
 
Total stockholders’ equity
   178,922   146,084 
   
 
 
  
 
 
 
Total liabilities and stockholders’ equity
  $355,564  $294,494 
   
 
 
  
 
 
 
The accompanying notes are an integral part of these unaudited consolidated financial statements.

4

Table of Contents
ORGANOGENESIS HOLDINGS INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited)

(amounts in thousands, except share and per share data)

   Three Months Ended
September 30,
  Nine Months Ended
September 30,
 
   2020  2019  2020  2019 

Net revenue

  $100,799  $64,265  $231,491  $186,336 

Cost of goods sold

   22,964   19,131   61,799   55,557 
  

 

 

  

 

 

  

 

 

  

 

 

 

Gross profit

   77,835   45,134   169,692   130,779 

Operating expenses:

     

Selling, general and administrative

   51,146   49,475   150,261   147,325 

Research and development

   3,709   3,924   13,787   11,159 
  

 

 

  

 

 

  

 

 

  

 

 

 

Total operating expenses

   54,855   53,399   164,048   158,484 
  

 

 

  

 

 

  

 

 

  

 

 

 

Income (loss) from operations

   22,980   (8,265  5,644   (27,705
  

 

 

  

 

 

  

 

 

  

 

 

 

Other expense, net:

     

Interest expense, net

   (2,969  (2,427  (8,391  (6,392

Loss on the extinguishment of debt

   —     —     —     (1,862

Gain on settlement of deferred acquisition consideration

   951   —     2,246   —   

Other income (expense), net

   44   (1  90   11 
  

 

 

  

 

 

  

 

 

  

 

 

 

Total other expense, net

   (1,974  (2,428  (6,055  (8,243
  

 

 

  

 

 

  

 

 

  

 

 

 

Net income (loss) before income taxes

   21,006   (10,693  (411  (35,948

Income tax expense

   (72  (48  (134  (108
  

 

 

  

 

 

  

 

 

  

 

 

 

Net income (loss)

   20,934   (10,741  (545  (36,056
  

 

 

  

 

 

  

 

 

  

 

 

 

Non-cash deemed dividend to warrant holders

   —     (645  —     (645
  

 

 

  

 

 

  

 

 

  

 

 

 

Net income (loss) attributed to common shareholders

  $20,934  $(11,386 $(545 $(36,701
  

 

 

  

 

 

  

 

 

  

 

 

 

Net income (loss) attributed to common shareholders, per share:

     

Basic

  $0.20  $(0.12 $(0.01 $(0.40
  

 

 

  

 

 

  

 

 

  

 

 

 

Diluted

  $0.19  $(0.12 $(0.01 $(0.40
  

 

 

  

 

 

  

 

 

  

 

 

 

Weighted-average common shares outstanding—basic and diluted

     

Basic

   105,040,035   92,276,858   104,748,297   91,182,233 
  

 

 

  

 

 

  

 

 

  

 

 

 

Diluted

   108,489,768   92,276,858   104,748,297   91,182,233 
  

 

 

  

 

 

  

 

 

  

 

 

 

   
Three Months Ended

June 30,
  
Six Months Ended

June 30,
 
   
2021
  
2020
  
2021
  
2020
 
Net revenue
  $123,196  $68,960  $225,748  $130,692 
Cost of goods sold
   29,940   20,042   55,435   38,835 
   
 
 
  
 
 
  
 
 
  
 
 
 
Gross profit
   93,256   48,918   170,313   91,857 
Operating expenses:
                 
Selling, general and administrative
   62,349   46,502   120,581   99,115 
Research and development
   7,320   4,668   13,529   10,078 
   
 
 
  
 
 
  
 
 
  
 
 
 
Total operating expenses
   69,669   51,170   134,110   109,193 
   
 
 
  
 
 
  
 
 
  
 
 
 
Income (loss) from operations
   23,587   (2,252  36,203   (17,336
   
 
 
  
 
 
  
 
 
  
 
 
 
Other expense, net:
                 
Interest expense, net
   (2,431  (2,912  (4,901  (5,422
Gain on settlement of deferred acquisition consideration
   —     —     —     1,295 
Other income, net
   18   25   15   46 
   
 
 
  
 
 
  
 
 
  
 
 
 
Total other expense, net
   (2,413  (2,887  (4,886  (4,081
   
 
 
  
 
 
  
 
 
  
 
 
 
Net income (loss) before income taxes
   21,174   (5,139  31,317   (21,417
Income tax expense
   (487  (27  (687  (62
   
 
 
  
 
 
  
 
 
  
 
 
 
Net income (loss)
  $20,687  $(5,166 $30,630  $(21,479
   
 
 
  
 
 
  
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Net income (loss), per share:
                 
Basic
  $0.16  $(0.05 $0.24  $(0.21
   
 
 
  
 
 
  
 
 
  
 
 
 
Diluted
  $0.15  $(0.05 $0.23  $(0.21
   
 
 
  
 
 
  
 
 
  
 
 
 
Weighted-average common shares outstanding
                 
Basic
   128,235,224   104,714,725   128,053,654   104,600,825 
   
 
 
  
 
 
  
 
 
  
 
 
 
Diluted
   133,988,413   104,714,725   133,721,191   104,600,825 
   
 
 
  
 
 
  
 
 
  
 
 
 
The accompanying notes are an integral part of these unaudited consolidated financial statements.

5

ORGANOGENESIS HOLDINGS INC.

CONSOLIDATED STATEMENTS OF REDEEMABLE COMMON STOCK AND STOCKHOLDERS’ EQUITY

(unaudited)

(amounts in thousands, except share data)

   Three and Nine Months Ended September 30, 2020 
   Redeemable           Additional        
   Common Stock   Common Stock   Paid-in   Accumulated  Total 
   Shares   Amount   Shares   Amount   Capital   Deficit  Stockholders’ Equity 

Balance as of June 30, 2020

   —     $—      105,417,168   $11   $228,225   $(192,486 $35,750 

Exercise of stock options

   —      —      92,033    —      318    —     318 

Stock-based compensation expense

   —      —      —      —      486    —     486 

Issuance of common stock associated with business acquisition

   —      —      1,947,953    —      7,986     7,986 

Net income

   —      —      —      —      —      20,934   20,934 
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

  

 

 

 

Balance as of September 30, 2020

   —     $—      107,457,154   $11   $237,015   $(171,552 $65,474 
  

 

 

   

 

 

   

 

 

   

��

 

   

 

 

   

 

 

  

 

 

 

Balance as of December 31, 2019

   —     $—      104,870,886   $10   $226,580   $(171,007 $55,583 

Exercise of stock options

   —      —      638,315    1    1,285    —     1,286 

Issuance of common stock associated with business acquisition

       1,947,953    —      7,986     7,986 

Stock-based compensation expense

   —      —      —      —      1,164    —     1,164 

Net loss

   —      —      —      —      —      (545  (545
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

  

 

 

 

Balance as of September 30, 2020

   —     $—      107,457,154   $11   $237,015   $(171,552 $65,474 
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

  

 

 

 

   Three and Nine Months Ended September 30, 2019 
   Redeemable           Additional        
   Common Stock   Common Stock   Paid-in   Accumulated  Total 
   Shares  Amount   Shares   Amount   Capital   Deficit  Stockholders’ Equity 

Balance as of June 30, 2019

   —    $—      91,342,722   $9   $178,412   $(155,223 $23,198 

Exercise of stock options

   —     —      64,362    —      109    —     109 

Exercise of common stock warrants

   —     —      19,426    —      —      —     —   

Common stock issued in warrant exchange

   —     —      3,315,232    —      645    (645  —   

Stock-based compensation expense

   —     —      —      —      242    —     242 

Net loss

   —     —      —      —      —      (10,741  (10,741
  

 

 

  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

  

 

 

 

Balance as of September 30, 2019

   —    $—      94,741,742   $9   $179,408   $(166,609 $12,808 
  

 

 

  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

  

 

 

 

Balance as of December 31, 2018

   728,548  $—      91,261,413   $9   $177,272   $(130,240 $47,041 

Adoption of ASC 606

   —     —      —      —      —      332   332 

Exercise of common stock warrants

   —     —      74,052    —      628    —     628 

Exercise of stock options

   —     —      91,045    —      163    —     163 

Common stock issued in warrant exchange

   —     —      3,315,232    —      645    (645  —   

Stock-based compensation expense

   —     —      —      —      700    —     700 

Redemption of redeemable common stock placed into treasury

   (728,548  —      —      —      —      —     —   

Net loss

   —     —      —      —      —      (36,056  (36,056
  

 

 

  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

  

 

 

 

Balance as of September 30, 2019

   —    $—      94,741,742   $9   $179,408   $(166,609 $12,808 
  

 

 

  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

  

 

 

 

   
Three and Six Months Ended June 30, 2021
 
  
 
  
 
Additional
  
 
  
 
 
   
Common Stock
   
Paid-in
  
Accumulated
  
Total
 
   
Shares
   
Amount
   
Capital
  
Deficit
  
Stockholders’ Equity
 
Balance as of March 31, 2021
  
 
128,102,255   $13   $298,095  $(140,816 $157,292
 
Exercise of stock options
   78,163    —      221   —     221 
Vesting of RSUs, net of shares surrendered to pay taxes
   102,823    —      (320      (320
Stock-based compensation expense
 �� —      —      1,042   —     1,042 
Net income
   —      —      —     20,687   20,687 
   
 
 
   
 
 
   
 
 
  
 
 
  
 
 
 
Balance as of June 30, 2021
   128,283,241   $13   $299,038  $(120,129 $178,922 
  
 
 
   
 
 
   
 
 
  
 
 
  
 
 
 
Balance as of December 31, 2020 (as reported)
   127,731,833   $13   $299,129  $(153,058 $146,084 
Adjustment due to Private Warrant reclassification
   —      —      (2,299  2,299   —   
   
 
 
   
 
 
   
 
 
  
 
 
  
 
 
 
Balance as of December 31, 2020 (as adjusted)
   127,731,833    13    296,830   (150,759  146,084 
Exercise of stock options
   363,507    —      1,205   —     1,205 
Vesting of RSUs, net of shares surrendered to pay taxes
   187,901    —      (737      (737
Stock-based compensation expense
   —      —      1,740   —     1,740 
Net income
   —      —      —     30,630   30,630 
   
 
 
   
 
 
   
 
 
  
 
 
  
 
 
 
Balance as of June 30, 2021
   128,283,241   $13   $299,038  $(120,129 $178,922 
   
 
 
   
 
 
   
 
 
  
 
 
  
 
 
 
  
   
Three and Six Months Ended June 30, 2020
 
  
 
  
Additional
 
  
 
  
 
 
   
Common Stock
   
 Paid-in 
  
Accumulated
  
Total
 
   
Shares
   
Amount
   
Capital
  
Deficit
  
Stockholders’ Equity
 
Balance as of March 31, 2020 (as reported)
   105,360,015   $11   $227,604  $(187,320 $40,295 
Adjustment due to Private Warrant reclassification
   —      —      (2,299  2,299   —   
   
 
 
   
 
 
   
 
 
  
 
 
  
 
 
 
Balance as of March 31, 2020 (as adjusted)
   105,360,015    11    225,305   (185,021  40,295 
Exercise of stock options
   57,153    —      152   —     152 
Stock-based compensation expense
   —      —      469   —     469 
Net loss
   —      —      —     (5,166  (5,166
   
 
 
   
 
 
   
 
 
  
 
 
  
 
 
 
Balance as of June 30, 2020 (as adjusted)
   105,417,168   $11   $225,926  $(190,187 $35,750 
  
 
 
   
 
 
   
 
 
  
 
 
  
 
 
 
Balance as of December 31, 2019 (as reported)
   104,870,886   $10   $226,580  $(171,007 $55,583 
Adjustment due to Private Warrant reclassification
   —      —      (2,299  2,299   —   
   
 
 
   
 
 
   
 
 
  
 
 
  
 
 
 
Balance as of December 31, 2019 (as adjusted)
   104,870,886    10    224,281   (168,708  55,583 
Exercise of stock options
   546,282    1    967   —     968 
Stock-based compensation expense
   —      —      678   —     678 
Net loss
   —      —      —     (21,479  (21,479
   
 
 
   
 
 
   
 
 
  
 
 
  
 
 
 
Balance as of June 30, 2020 (as adjusted)
   105,417,168   $11   $225,926  $(190,187 $35,750 
   
 
 
   
 
 
   
 
 
  
 
 
  
 
 
 
The accompanying notes are an integral part of these unaudited consolidated financial statements.

6

Table of Contents
ORGANOGENESIS HOLDINGS INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)

(amounts in thousands)

   Nine Months Ended
September 30,
 
   2020  2019 

Cash flows from operating activities:

   

Net loss

  $(545 $(36,056

Adjustments to reconcile net loss to net cash used in operating activities:

   

Depreciation

   2,749   2,553 

Amortization of intangible assets

   2,518   4,526 

Non-cash interest expense

   160   196 

Deferred interest expense

   1,577   974 

Deferred rent expense

   33   606 

Gain on settlement of deferred acquisition consideration

   (2,246  —   

Recovery of certain notes receivable from related parties

   (1,111  —   

Provision (benefit) recorded for sales returns and doubtful accounts

   2,559   (29

Loss on disposal of property and equipment

   201   —   

Adjustment for excess and obsolete inventories

   2,024   809 

Stock-based compensation

   1,164   700 

Loss on extinguishment of debt

   —     1,862 

Changes in operating assets and liabilities:

   

Accounts receivable

   (19,160  553 

Inventory

   (7,757  (7,840

Prepaid expenses and other current assets

   (2,262  (699

Accounts payable

   (3,778  5,348 

Accrued expenses and other current liabilities

   3,521   85 

Other liabilities

   878   (715
  

 

 

  

 

 

 

Net cash used in operating activities

   (19,475  (27,127

Cash flows from investing activities:

   

Purchases of property and equipment

   (12,260  (2,526

Proceeds from the repayment of notes receivable from related parties

   1,726   —   

Cash paid for business acquisition

   (5,820 

Acquisition of intangible asset

   —     (250
  

 

 

  

 

 

 

Net cash used in investing activities

   (16,354  (2,776

Cash flows from financing activities:

   

Line of credit borrowings

   5,869   7,000 

Proceeds from term loan

   10,000   50,000 

Repayment of notes payable

   —     (17,585

Proceeds from the exercise of stock options

   1,286   163 

Proceeds from the exercise of common stock warrants

   —     628 

Redemption of redeemable common stock placed into treasury

   —     (6,762

Principal repayments of capital lease obligations

   (1,776  (863

Payment of deferred acquisition consideration

   (3,034  —   

Payment of debt issuance costs

   —     (924
  

 

 

  

 

 

 

Net cash provided by financing activities

   12,345   31,657 

Change in cash and restricted cash

   (23,484  1,754 

Cash and restricted cash, beginning of period

   60,370   21,405 
  

 

 

  

 

 

 

Cash and restricted cash, end of period

  $36,886  $23,159 
  

 

 

  

 

 

 

Supplemental disclosure of cash flow information:

   

Cash paid for interest

  $7,130  $5,922 

Cash paid for income taxes

  $—    $110 

Supplemental disclosure of non-cash investing and financing activities:

   

Fair value of shares issued for business acquisition

  $7,986  $—   

Deferred acquisition consideration and earnout liability recorded for business acquisition

  $5,218  $—   

Debt and equity issuance costs included in accounts payable

  $—    $91 

Purchases of property and equipment included in accounts payable and accrued expenses

  $2,628  $3,698 

Amounts due related to acquisition of intangible assets included in accrued expenses and other liabilities

  $—    $500 

Non-cash deemed dividend related to warrant exchange

  $—    $645 

Equipment acquired under capital lease

  $—    $973 

   
Six Months Ended

June 30,
 
   
2021
  
2020
 
Cash flows from operating activities:
         
Net income (loss)
  $30,630  $(21,479
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:
         
Depreciation
   2,073   1,793 
Amortization of intangible assets
   2,486   1,633 
Amortization of operating lease
right-of-use
assets
   2,562   —   
Non-cash
interest expense
   143   103 
Deferred interest expense
   1,036   1,022 
Deferred rent expense
   —     64 
Gain on settlement of deferred acquisition consideration
   —     (1,295
Provision recorded for sales returns and doubtful accounts
   2,158   970 
Loss on disposal of property and equipment
   239   201 
Adjustment for excess and obsolete inventories
   4,678   1,709 
Stock-based compensation
   1,740   678 
Change in fair value of Earnout liability
   (3,058  —   
Changes in operating assets and liabilities:
         
Accounts receivable
   (22,122  (5,727
Inventory
   (4,984  (7,353
Prepaid expenses and other current assets
   (1,649  (1,302
Operating leases
   (2,774  —   
Accounts payable
   716   235 
Accrued expenses and other current liabilities
   2,646   1,266 
Other liabilities
   (340  864 
   
 
 
  
 
 
 
Net cash provided by (used in) operating activities
   16,180   (26,618
Cash flows from investing activities:
         
Purchases of property and equipment
   (9,290  (6,411
Proceeds from the repayment of notes receivable from related parties
      293 
   
 
 
  
 
 
 
Net cash used in investing activities
   (9,290  (6,118
Cash flows from financing activities:
         
Line of credit borrowings
   —     5,869 
Proceeds from term loan
   —     10,000 
Payments of withholding taxes in connection with RSUs vesting
   (737  —   
Proceeds from the exercise of stock options
   1,205   968 
Principal repayments of finance lease obligations
   (1,374  (1,149
Payment of deferred acquisition consideration
   (483  (2,568
   
 
 
  
 
 
 
Net cash (used in) provided by financing activities
   (1,389  13,120 
Change in cash and restricted cash
   5,501   (19,616
Cash and restricted cash, beginning of period
   84,806   60,370 
   
 
 
  
 
 
 
Cash and restricted cash, end of period
  $90,307  $40,754 
   
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
Supplemental disclosure of cash flow information:
         
Cash paid for interest
  $3,836  $4,626 
Cash paid for income taxes
  $582  $—   
Supplemental disclosure of
non-cash
investing and financing activities:
         
Purchases of property and equipment included in accounts payable and accrued expenses
  $4,349  $4,692 
Right-of-use
assets obtained through operating lease obligations
  $29,092  $—   
The accompanying notes are an integral part of these unaudited consolidated financial statements.

7

Table of Contents
ORGANOGENESIS HOLDINGS INC.

NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS

(amounts in thousands, except share and per share data)

1. Nature of the Business and
Basis of Presentation

Organogenesis Holdings Inc. (formerly Avista Healthcare Public Acquisition Corp.) (“ORGO” or the “Company”) is a leading regenerative medicine company focused on the development, manufacture, and commercialization of solutions for the Advanced Wound Care and Surgical & Sports Medicine markets. ManySeveral of the existing and pipeline products in the Company’s portfolio have Premarket Application (“PMA”) approval, Business License Applicant (“BLA”) approval or Premarket Notification 510(k) clearance from the United States Food and Drug Administration (“FDA”). The Company’s customers include hospitals, wound care centers, government facilities, ambulatory service centers (“ASCs”) and physician offices. The Company has one1 operating and reportable segment.

COVID-19
pandemic

The emergence of the coronavirus
(COVID-19)
around the world, and particularly in the United States, continues to present significant risks to the Company. While the
COVID-19
pandemic has not materially adversely affected the Company’s financial results and business operations through the thirdsecond quarter ended SeptemberJune 30, 2020,2021, the Company is unable to predict the impact that
COVID-19
will have on its financial position and operating results because of the numerous uncertainties created by the unprecedented nature of the pandemic. The public health actions being undertaken to reduce the spread of the virus, and that may have to be undertaken again in the event of a resurgence of the virus, may create significant disruptions to the Company with respect to: (i) the demand for its products, (ii) the ability of its sales representatives to reach healthcare customers, (iii) its ability to maintain staffing levels to support its operations, (iv) its ability to continue to manufacture certain of its products, (v) the reliability of its supply chain and (vi) its ability to achieve the financial covenants required under the 2019 Credit Agreement (see Note “11. Long-Term Debt Obligations”). The extent to which the COVID-19 pandemic may impact the Company’s business will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the duration of the outbreak, travel restrictions and social distancing in the U.S. and other countries, business closures or business disruptions and the effectiveness of actions taken in the U.S. and other countries to contain and treat the disease.

The Company is closelyclos
e
ly monitoring the evolving impact of the pandemic on all aspects of its business. The Company has implemented a number of measures designed to protect the health and safety of its employees, support its customers and promote business continuity. The Company is also actively reviewing and implementing cost-saving measures including discontinuing or delaying all non-essential services and programs and instituting controls on travel, events, marketing and clinical studies to adapt the business plan for the evolving COVID-19 challenges.

Merger with Avista Healthcare Public Acquisition Corp

On December 10, 2018, Avista Healthcare Public Acquisition Corp., our predecessor company (“AHPAC”), consummated
a business combination
(the previously announced merger (the “Avista Merger”) pursuant to an Agreement and Plan of Merger, dated as of August 17, 2018 (as amended, the “Avista Merger Agreement”), by and among AHPAC, Avista Healthcare Merger Sub, Inc., a Delaware corporation and a direct wholly-owned subsidiary of AHPAC (“Avista Merger Sub”) and Organogenesis Inc., a Delaware corporation (“Organogenesis Inc.”). As a result of the Avista Merger and the other transactions contemplated by the Avista Merger Agreement, Avista Merger Sub merged with and into Organogenesis Inc., with Organogenesis Inc. surviving the Avista Merger and becoming a wholly-owned subsidiary of AHPAC. AHPAC changed its name to Organogenesis Holdings Inc. (ORGO).

The Avista Merger was accounted for as a reverse merger in accordance with accounting principles generally accepted in the United States of America (“GAAP”). Under this method of accounting, AHPAC was treated as the “acquired” company for accounting purposes. This determination was primarily based on Organogenesis Inc.’s equity holders having a majority of the voting power of the combined company, Organogenesis Inc. comprising the ongoing operations of the combined entity, Organogenesis Inc. comprising a majority of the governing body of the combined company, and Organogenesis Inc.’s senior management comprising the senior management of the combined company. Accordingly, for accounting purposes, the Avista Merger was treated as the equivalent of Organogenesis Inc. issuing stock for the net assets of AHPAC, accompanied by a recapitalization. The net assets of AHPAC were recorded at historical cost, with no goodwill or other intangible assets recorded. Operations prior to the Avista Merger are those of Organogenesis Inc.

Liquidity and Financial Conditions

In accordance with ASC
205-40,
 Going Concern
 (“ASC
205-40”),
the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the financial statements are issued. WhileSince its inception, the Company has reported net income for the three months ended September 30, 2020, the Company has recurring losses from operations since its inception and has funded its operations primarily with cash flow from product sales, and proceeds from loans from affiliates and entities controlled by its affiliates, sales of its Class A common stock and third-party debt. As of SeptemberJune 30, 2020,2021, the Company had an accumulated deficit of $171,552$120,129 and working capital of $62,765. During$117,218. The Company also had up to $30,000 available (subject to Borrowing Base) for future revolving borrowings under our Revolving Facility (see Note “13. Long-Term Debt Obligations”). For the ninesix months ended SeptemberJune 30, 2020,2021, the Company incurredhas generated a net lossincome of $545$30,630 and used $19,475$16,180 of cash in operations. The Company may continue to incur negative cash flows from operations and operating losses in the future as the Company expends resources to grow the organization to support the planned expansion of the business. The Company expects that its cash of $36,512$89,790 and other components of working capital of $62,765$27,428 as of SeptemberJune 30, 2020,2021, plus net cash flows from product sales and availability under the 2019 Credit Agreement, will be sufficient to fund its operating expenses, capital expenditure requirements and debt service payments for at least 12 months beyond the filing date of this quarterly report. The Company is closely monitoring ongoing developments in connection with the COVID-19 pandemic, which may negatively impact its commercial prospects, projected cash position and access to capital in the future. The Company will continue to assess its cash position and, if circumstances warrant, make appropriate adjustments to its operating plan.

8

The Company expects to continue investing in product development, sales and marketing, and customer support for its products. The Company may seek to raise additional funding through public and/or private equity financings, debt financings, or other strategic transactions. There can be no assurance that the Company will be able to obtain additional debt or equity financing on terms acceptable to the Company, on a timely basis or at all, particularly in light of the adverse impacts of the COVID-19 pandemic on the capital markets.all. The failure of the Company to obtain sufficient funds on acceptable terms when needed could have a material adverse effect on the Company’s business, results of operations, and financial condition. The Company’s current borrowings under the 2019 Credit Agreement are subject to compliance with certain financial covenants that include maintaining Minimum Trailing Twelve Month Consolidated Revenue and Non-PuraPly Revenue. If the Company is not able to comply with these covenants, due to the impacts of COVID-19 or otherwise, the borrowings under the 2019 Credit Agreement may become due and payable immediately unless the Company obtains an amendment or waiver from its lenders. There can be no assurance that the Company’s lenders would agree to any such amendment or waiver on acceptable terms, or at all.

2. Summary of Significant Accounting Policies

Unaudited Interim Financial Information

The accompanying unaudited consolidated financial statements have been prepared by management in accordance with GAAP and in accordance with the rules and regulations of the Securities and Exchange Commission (the “SEC”) regarding interim financial reporting. Accordingly, they do not include all the information and footnotes required by generally accepted accounting principles for complete financial statements. While we believe that the disclosures presented are adequate in order to make the information not misleading, these unaudited quarterly financial statements should be read in conjunction with the financial statements and notes thereto included in the Company’s Annual Report on Form
10-K
for the fiscal year ended December 31, 20192020 (the “Annual Report”).

The unaudited consolidated financial statements include the accounts and results of operations of Organogenesis Holdings Inc. and its wholly-owned or controlled subsidiaries of Organogenesis Inc., including Organogenesis GmbH (a Switzerland corporation) and Prime Merger Sub, LLC. All intercompany balances and transactions have been eliminated in consolidation. The Company considers events or transactions that occur after the balance sheet date but before the financial statements are issued to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure. In the opinion of management, the unaudited consolidated financial statements reflect all adjustments of a normal recurring nature necessary for a fair presentation of the Company’s financial position, results of operations and cash flows at the dates and for the periods indicated. The results for the ninesix months ended SeptemberJune 30, 20202021 are not necessarily indicative of the results to be expected for the year ending December 31, 2020,2021, any other interim periods, or any future years or periods.

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the related disclosure as of the date of the consolidated financial statements and the reported results of operations during the reporting period.periods. Actual results could differ from those estimates.

Summary of Significant Accounting Policies

The Company’s significant accounting policies are described in Note “2. Significant Accounting Policies” to the Consolidated Financial Statements included in the Annual Report. There have been no material changes to the significant accounting policies previously disclosed in the Annual Report.

Report, other than as it related to the recently adopted accounting pronouncement disclosed below.

Revision to Previously Issued Financial Statements
On April 12, 2021, the Staff of the SEC issued a statement regarding the accounting and reporting considerations for warrants issued by special purpose acquisition companies entitled “Staff Statement on Accounting and Reporting Considerations for Warrants Issued by Special Purpose Acquisition Companies (“SPACs”)” (the “SEC Statement”). In the SEC Statement, the SEC Staff expressed its view that certain terms and conditions common to SPAC warrants may require the warrants to be classified as liabilities on the SPAC’s financial statements as opposed to equity.
As of December 31, 2018, the Company had 4.1 million private warrants outstanding, which were issued to Avista Capital Partners IV, L.P. and Avista Capital Partners IV (Offshore), L.P. in connection with the Avista Merger on December 10, 2018 (the “Private Warrants”), and 31.0 million public warrants outstanding that were issued in connection with the initial public offering of Avista Healthcare Public Acquisition Corp. on October 10, 2016 (the “Public Warrants”, together with the Private Warrants, the “Warrants”). The Company originally classified the Warrants as equity on its financial statements. In 2019, the outstanding Warrants were exchanged for 3.3 million shares of the Company’s Class A common stock. There were 0 Warrants outstanding as of December 31, 2019.
As a result of the SEC Statement, the Company reevaluated the historical accounting treatment of its Public Warrants and Private Warrants and determined that the Private Warrants should have been recorded at fair value as a liability in the Company’s consolidated balance sheet with changes to
9

the fair value recorded to the consolidated statements of operations. The Company assessed the materiality of this error on prior period financial statements in accordance with SEC Staff Accounting Bulletin Number 99, Materiality, and ASC
250-10,
Accounting Changes and Error Corrections. The Company determined that this error was not material to the financial statements of any prior annual or interim period. The Company reclassified $2,299 from additional
paid-in
capital to accumulated deficit on the consolidated balance sheet as of December 31, 2020 as the cumulative adjustment for this error.
Recently Adopted Accounting
Pronouncements
In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update
No. 2016-02
(“ASU
2016-02”), Leases
(Topic 842), as further amended (“ASC 842”), to increase transparency and comparability among organizations by requiring the recognition of, at the lease commencement date, a lease liability for the obligation to make lease payments, and a
right-of-use
(“ROU”) asset for the right to use the underlying asset, on the balance sheet. Although the Company remains an emerging growth company until December 31, 2021, it elected to early adopt ASC 842 on January 1, 2021. ASC 842 requires a modified retrospective transition method that could either be applied at the earliest comparative period in the financial statements or in the period of adoption. The Company elected to use the period of adoption (January 1, 2021) transition method and therefore did not recast prior periods. Results for reporting periods beginning on January 1, 2021 are presented under ASC 842, while prior period amounts continue to be reported and disclosed in accordance with the Company’s historical accounting treatment under Accounting Standards Codification 840, Leases (“ASC 840”). In addition, the Company elected the package of practical expedients permitted under the transition guidance within the new standard, which allowed the Company: (1) to carry forward the historical lease classification; (2) not to reassess whether expired or existing contracts are or contain leases; and, (3) not to reassess the treatment of initial direct costs for existing leases. The Company made an accounting policy election under ASC 842 not to recognize ROU assets and lease liabilities for leases with a term of 12 months or less. The Company also elected to account for lease components and the associated
non-lease
components in the contracts as a single lease component for most of the leased assets. Upon the adoption of this standard on January 1, 2021, the Company recognized an operating lease liability of $15,935, representing the present value of the minimum lease payments remaining as of the adoption date, and a
right-of-use
asset in the amount of $13,525. The
right-of-use
asset reflects adjustments for
de-recognition
of deferred lease liabilities and lease incentives. The Company’s accounting for finance leases (previously classified as capital leases under ASC 840) remained substantially unchanged. See Note “17. Leases” for further disclosures.
Recently Issued Accounting Pronouncements Not Yet Adopted

In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) (“ASU 2016-02”), which applies to all leases and will require lessees to record most leases on the balance sheet but recognize expenses in a manner similar to the current standard. In July 2018, the FASB issued ASU 2018-10, Codification Improvements to Topic 842, Leases, which provides narrow amendments to clarify how to apply certain aspects of ASU 2016-02, and ASU 2018-11, Leases (Topic 842): Targeted Improvements, which provides adopters an additional transition method by allowing entities to initially apply ASU 2016-02, and subsequent related standards, at the adoption date and recognize a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption. Additionally, in March 2019, the FASB issued ASU 2019-01, Leases (Topic 842): Codification Improvements, which clarifies the transition guidance related to interim disclosures provided in the year of adoption. ASU 2016-02 and related amendments and improvements are effective for fiscal years beginning after December 15, 2018 for public business entities and interim periods within those years and for all other entities for years beginning after December 15, 2020. Entities are required to use a modified retrospective approach of adoption for leases that exist or are entered into after the beginning of the transition date. A full retrospective application is prohibited. The Company is a public entity but took advantage of the relief provided for emerging growth companies to allow them to follow the private company adoption timelines and the Company will adopt this standard and the related improvements on January 1, 2021 by recognizing a cumulative-effect adjustment for any impact. The Company continues to evaluate the impact of adopting this standard on its accounting policies, financial statements, business processes, systems and internal controls. Additionally, the Company has established a project management and implementation team consisting of internal resources and external advisors. These evaluation and implementation processes are expected to continue through 2020. The Company expects to recognize all of its leases with terms over twelve months on the balance sheet by recording a right-of-use asset and a corresponding lease liability.

In June 2016, the FASB issued
ASU 2016-13
, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments
 (“ASU 2016-13”). Subsequent
to the issuance of
ASU 2016-13, the
FASB has issued the following updates:
ASU 2018-19,
 Codification Improvements to Topic 326, Financial Instruments- Credit Losses
,
ASU 2019-04,
 Codification Improvements to Topic 326, Financial Instruments—Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments
,
ASU 2019-05,
 Financial Instruments—Credit Losses (Topic 326)—Targeted Transition Relief
 and
ASU 2019-11,
 Codification Improvements to Topic 326, Financial Instruments—Credit Losses
. The objective of
ASU 2016-13 and
all the related updates is to provide financial statement users with more decision-useful information about the expected credit losses on financial instruments and other commitments to extend credit held by a reporting entity at each reporting date. The amendments in this ASU replace the incurred loss impairment methodology in current GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates.
ASU 2016-13 and
the related updates are effective for fiscal years, and interim periods within those years, beginning after December 15, 2019 for public business entities excluding entities eligible to be smaller reporting companies and for fiscal years, and interim periods within those years, beginning after December 15, 2022 for all other entities. Early adoption is permitted. The Company is a smaller reporting company and follows the private company adoption timelines and the Company will adopt this standard and the related improvements on January 1, 2023 by recognizing a cumulative-effect adjustment to retained earnings for any impact. The Company is currently assessing the adoption of
ASU 2016-13
and
the related improvements is not expected to have a material impact on the Company’s consolidated financial statements.

10

3. Acquisition

On September 17, 2020 (the “Acquisition Date”), the Company acquired certain assets and assumed certain liabilities of CPN Biosciences, LLC (“CPN”) pursuant to an asset purchase agreement dated July 24, 2020. CPN offered a physician office management solution and advanced wound care products.

The aggregate consideration amounted to $19,024 as of the Acquisition Date, subject to post-closing adjustments for working capital. Total consideration consisted of $6,427 in cash, 2,151,438 shares of the Company’s Class A common stock with a fair value of $8,815, and contingent consideration (the “Earnout” or “Earnout Liability”) with a fair value of $3,782. On the Acquisition Date, the Company paid $5,820 in cash and issued 1,947,953 shares of the Company’s class A common stock. The remaining consideration of $1,436 was held back (the “Holdback”) and will be paid or issued, as applicable, eighteen months after the Acquisition Date, subject to any offsetting indemnification claims against CPN.

The Company is obligated to pay an Earnout a contingent consideration (the “Earnout”)
to CPN’s former shareholders if CPN’s legacy product revenue in the Earnout Period (defined as a twelve-month period, starting on January 1, 2021 (the “Earnout Period”)the first day of the next calendar quarter immediately following the post-closing sales meeting), exceeds CPN’s 2019 revenue. The amount of the Earnout, if any, will be equal to 70% of the excess and will be payable 60 days after the expiration of the Earnout Period. The post-closing sales meeting
took place
in MarchApril 2021 and the Earnout Period is July 1, 2021 to June 30, 2022. The Company recorded a
non-current
liability of $3,782 on the Acquisition Date for the fair value of the contingent consideration related to the expected Earnout. The Earnout Liability is classified as a Level 3 measurement for which fair value is derived from inputs that are unobservable and significant toCompany assesses the overall fair value measurement. The fair value of suchthe Earnout Liability isliability at each reporting period. As of June 30, 2021, the Earnout liability was estimated using a Monte Carlo simulation model that utilizes key assumptions including forecasted revenues and volatilitiesat $927. Subsequent changes in the estimated fair value of the underlying financial metrics duringliability are reflected in earnings until the Earnout period.

This transaction was accounted for as a business combination using the acquisition methodliability is settled (see Note “5. Fair Value Measurement of accounting in accordance with ASC Topic 805, Business CombinationsFinancial Instruments”). Assets acquired and liabilities assumed have been recorded at their estimated fair values as of the Acquisition Date. The fair values of intangible assets were based on valuations using various income approaches and methods, such as the multiperiod excess earnings method, relief from royalty method, etc., which require the use of significant estimates and assumptions, including estimating future cash flows and developing appropriate discount rates. The excess of the purchase price over the tangible assets, identifiable intangible assets and assumed liabilities was recorded as goodwill.

Based upon a preliminary valuation, the total purchase price allocation was as follows:

Assets acquired:

  

Accounts receivable

  $1,048 

Inventory

   1,230 

Prepaid expenses and other current assets

   1 

Property and equipment

   85 

Intangible assets

   13,570 

Other assets

   4 
  

 

 

 

Total assets acquired

   15,938 

Liabilities assumed:

  

Accounts payable

   51 

Accrued expenses and other current liabilities

   240 
  

 

 

 

Total liabilities assumed

   291 

Total identifiable assets acquired, net

   15,647 

Total purchase price

   19,024 
  

 

 

 

Goodwill

  $3,377 
  

 

 

 

The preliminary fair values recorded were based on a preliminary valuation and the estimates and assumptions used in such valuation are subject to change, which could be significant, within the measurement period (up to one year from the acquisition date). The Company is continuing to obtain information to determine the acquired assets and liabilities, including tax assets, liabilities and other attributes.

The preliminary purchase price allocation resulted in goodwill of $3,377, which will be deductible for income tax purposes. The resulting amount of goodwill is primarily attributed to expected synergies from cross-sale opportunities and future growth. Intangible assets of $13,570 include customer relationships of $10,690, developed technologies of $2,050, non-competition agreements of $750, and trademarks of $80, which are being amortized on a straight-line basis, over weighted-average useful lives of 10 years, 6 years, 5 years and 1 year, respectively.

At the time of the acquisition, CPN had approximately 30 employees. The results of operations of CPN have been included in the Company’s consolidated financial statements beginning on the Acquisition Date. Revenue and expenses of CPN since the Acquisition Date were not material. The acquisition of CPN does not result in any changes to the Company’s operating or reportable segment structure.

4. Product and
Geographic Sales

The Company generates revenue through the sale of Advanced Wound Care and Surgical & Sports Medicine products. There is a single performance obligation in all of the Company’s contracts, which
w
hich is the Company’s promise to transfer the Company’s products to customers based on specific payment and shipping termst
e
rms in the arrangement. The entire transaction price reflects a single performance obligation. Product revenue is recognized when a customer obtains control of the Company’s products which occurs at a point in time and may be upon shipment, procedure date, or delivery, based on the terms of the contract. Revenue is recorded net of a reserve for returns, discounts and Group Purchasing Organization (“GPO”) rebates, which represent a direct reduction to the revenue recognized. These reductions are accrued at the time revenue is recognized, based upon historical experience and specific circumstances. For the three months ended SeptemberJune 30, 20202021 and 2019,2020, the Company recorded GPO fees of $1,013$829 and $880,$837, respectively, as a direct reduction of revenue. For the ninesix months ended SeptemberJune 30, 20202021 and 2019,2020, the Company recorded GPO fees of $2,810$1,529 and $1,991,$1,797, respectively, as a direct reduction of revenue.

The following tables set forth revenue by product category:

   Three Months Ended
September 30,
 
   2020   2019 

Advanced Wound Care

  $89,990   $54,310 

Surgical & Sports Medicine

   10,809    9,955 
  

 

 

   

 

 

 

Total net revenue

  $100,799   $64,265 
  

 

 

   

 

 

 

   Nine Months Ended
September 30,
 
   2020   2019 

Advanced Wound Care

  $201,009   $157,365 

Surgical & Sports Medicine

   30,482    28,971 
  

 

 

   

 

 

 

Total net revenue

  $231,491   $186,336 
  

 

 

   

 

 

 

For the three months ended September 30, 2020 and 2019, net PuraPly revenue totaled $40,945 and $31,755, respectively. For the nine months ended September 30, 2020 and 2019, net PuraPly revenue totaled $101,969 and $86,893, respectively.

   
Three Months Ended

June 30,
 
   
2021
   
2020
 
Advanced Wound Care
  $111,436   $
 
59,731 
Surgical & Sports Medicine
   11,760    9,229 
   
 
 
   
 
 
 
Total net revenue
  $123,196   $68,960 
   
 
 
   
 
 
 
   
Six Months Ended

June 30,
 
   
2021
   
2020
 
Advanced Wound Care
  $202,144   $111,019 
Surgical & Sports Medicine
   23,604    19,673 
   
 
 
   
 
 
 
Total net revenue
  $225,748   $130,692 
   
 
 
   
 
 
 
For all periods presented, net revenue generated outside the United States represented less than 1% of total net revenue.

5. Fair Value of Financial Assets and Liabilities

The following table presents information about the Company’s financial assets and liabilities measured at fair value on a recurring basis and indicates the level of the fair value hierarchy utilized to determine such fair values as of SeptemberJune 30, 2020. There was no such assets or liabilities as of2021 and December 31, 2019.

   Fair Value Measurements 
   as of September 30, 2020 Using: 
   Level 1   Level 2   Level 3   Total 

Liabilities:

        

Earnout Liability

  $—     $—     $3,782   $3,782 
  

 

 

   

 

 

   

 

 

   

 

 

 
  $—     $—     $3,782   $3,782 
  

 

 

   

 

 

   

 

 

   

 

 

 

2020.

11

   
Fair Value Measurements

as of June 30, 2021 Using:
 
   
Level 1
   
Level 2
   
Level 3
   
Total
 
Liabilities:
        
Earnout liability
  $
 
—     $
 
—     $
 
927   $
 
927 
   
 
 
   
 
 
   
 
 
   
 
 
 
   
$
 
—  
 
  
$
 
—  
 
  
$
 
927   $927
 
   
 
 
   
 
 
   
 
 
   
 
 
 
   
Fair Value Measurements

as of December 31, 2020 Using:
 
   
Level 1
   
Level 2
   
Level 3
   
Total
 
Liabilities:
                    
Earnout liability
  $—     $—     $3,985   $3,985 
   
 
 
   
 
 
   
 
 
   
 
 
 
   
$
—  
 
  
$
—  
 
  $3,985   $3,985
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Earnout Liability

In connection with accounting for the CPN acquisition on September 17, 2020, the Company recorded an Earnout liability of $3,782 on the Earnout LiabilityAcquisition Date, representing the fair value of contingent consideration payable upon the achievement of a certain revenue target. The Earnout Liability was valued using the Monte Carlo simulation model based on inputs that are not observable in the market, which representsis classified as a levelLevel 3 measurement within the fair value hierarchy. Changes inhierarchy for which fair value is derived from inputs that are unobservable and significant to the overall fair value measurement. The fair value of such Earnout Liability is estimated using a Monte Carlo simulation model that utilizes key assumptions including forecasted revenues and volatilities of the underlying financial metrics during the Earnout period. The Company assesses the fair value of the Earnout Liability will beliability at each reporting period. Any subsequent changes in the estimated fair value of the liability are reflected in selling, general and administrative expenses until the liability is fully settled. For more information about the Earnout Liability,liability, refer to Note “3. Acquisition”.

As of June 30, 2021, the Earnout liability decreased to $927 as a result of the Company’s updated assessment of the near-term market for the CPN product portfolio. The following table provides a roll-forward of the fair value of the Company’s Earnout liability, for which fair value is determined using Level 3 inputs:

   
Earnout liability
 
Balance as of December 31, 2020
  $3,985 
Change in fair value
   (3,058
   
 
 
 
Balance as of June 30, 2021
  $927 
   
 
 
 
The Company did not have any financial assets and liabilities measured at fair value on a
non-recurring
basis as of SeptemberJune 30, 20202021 and December 31, 2019.

2020.

6. Accounts Receivable, Net

Accounts receivable consisted of the following:

   September 30,   December 31, 
   2020   2019 

Accounts receivable

  $62,040   $42,408 

Less — allowance for sales returns and doubtful accounts

   (5,125   (3,049
  

 

 

   

 

 

 
  $56,915   $39,359 
  

 

 

   

 

 

 

   
June 30,
   
December 31,
 
   
2021
   
2020
 
Accounts receivable
  $    83,880   $61,792 
Less — allowance for sales returns and doubtful accounts
   (7,113   (4,988
   
 
 
   
 
 
 
   $76,767   $56,804 
   
 
 
   
 
 
 
12

Table of Contents
The Company’s allowance for sales returns and doubtful accounts was comprised of the following:

   Three Months Ended
September 30,
   Nine Months Ended
September 30,
 
   2020   2019   2020   2019 

Balance at beginning of period

  $3,928   $3,021   $3,049   $3,420 

Additions (reductions)

   1,589    (56   2,559    (29

Write-offs

   (392   (30   (483   (456
  

 

 

   

 

 

   

 

 

   

 

 

 

Balance at end of period

  $5,125   $2,935   $5,125   $2,935 
  

 

 

   

 

 

   

 

 

   

 

 

 

   
Three Months Ended

June 30,
   
Six Months Ended

June 30,
 
   
2021
   
2020
   
2021
   
2020
 
Balance at beginning of period
  $6,076   $3,204   $4,988   $3,049 
Additions 
   1,056    753    2,158    970 
Write-offs
   (19   (29   (33   (91
   
 
 
   
 
 
   
 
 
   
 
 
 
Balance at end of period
  $7,113   $3,928   $7,113   $3,928 
   
 
 
   
 
 
   
 
 
   
 
 
 
7. Inventories

Inventories, net of related reserves for excess and obsolescence, consisted of the following:

   September 30,   December 31, 
   2020   2019 

Raw materials

  $9,676   $9,178 

Work in process

   1,499    781 

Finished goods

   18,707    12,959 
  

 

 

   

 

 

 
  $29,882   $22,918 
  

 

 

   

 

 

 

   
June 30,
   
December 31,
 
   
2021
   
2020
 
Raw materials
  $
 
     10,144   $10,075 
Work in process
   1,732    1,305 
Finished goods
   16,230    16,419 
   
 
 
   
 
 
 
   $28,106   $27,799 
   
 
 
   
 
 
 
Raw materials include various components used in the Company’s manufacturing process. The Company’s excess and obsolete inventory review process includes analysis of sales
s
ales forecasts and historical sales as compared to inventory level, and working with operations to maximize recovery of excess inventory. During the three months ended SeptemberJune 30, 20202021 and 2019,2020, the Company charged $315$2,388 and $286,$940, respectively, for inventory excess and obsolescence to cost of goods sold within the consolidated statements of operations. During the ninesix months ended SeptemberJune 30, 20202021 and 2019,2020, the Company charged $2,024$4,678 and $809,$1,709, respectively, for inventory excess and obsolescence to cost of goods sold within the consolidated statements of operations.

8. Prepaid Expenses and
Other Current Assets
Prepaid expenses and other current assets consisted of the following:
   
June 30,

2021
   
December 31,

2020
 
Subscriptions  $
 
 
 
      2,211   $2,013 
Conferences and marketing expenses   921    63 
Deposits   1,796    1,438 
Reimbursement of offering expenses
   0      1,009 
Other
   1,655    412 
   
 
 
   
 
 
 
   $
6,583
 
  $
4,935
 
   
 
 
   
 
 
 
Prepaid deposits are deposits held by vendors which are expected to be released within twelve months and therefore they are recorded as current assets.
13

9. Property and Equipment, Net

Property and equipment consisted of the following:

   September 30,   December 31, 
   2020   2019 

Leasehold improvements

  $39,169   $36,344 

Furniture, computers and equipment

   47,798    46,430 
  

 

 

   

 

 

 
   86,967    82,774 

Accumulated depreciation and amortization

   (68,559   (65,812

Construction in progress

   37,529    30,222 
  

 

 

   

 

 

 
  $55,937   $47,184 
  

 

 

   

 

 

 

   
June 30,
   
December 31,
 
   
2021
   
2020
 
Leasehold improvements
  $
 
    48,503   $39,574 
Furniture, computers and equipment
   50,221    48,236 
   
 
 
   
 
 
 
    98,724    87,810 
Accumulated depreciation and amortization
   (71,593   (69,521
Construction in progress
   42,608    41,779 
   
 
 
   
 
 
 
   $69,739   $60,068 
   
 
 
   
 
 
 
Depreciation expense was $956$1,063 and $792$891 for the three months ended SeptemberJune 30, 20202021 and 2019.2020. Depreciation expense was $2,749$2,073 and $2,553$1,793 for the ninesix months ended SeptemberJune 30, 20202021 and 2019.2020. As of SeptemberJune 30, 20202021 and December 31, 2019,2020, the Company had $21,689 of buildings under capitalfinance leases recorded within leasehold improvements. As of SeptemberJune 30, 20202021 and December 31, 2019,2020, the Company had $14,675$15,573 and $13,777$14,974 recorded within accumulated depreciation and amortization related to buildings under capitalfinance leases, respectively. Construction in progress primarily represents unfinished construction work on a building under a capitalfinance lease and, more recently, improvements at the Company’s leased facilities in Canton and Norwood, Massachusetts.

9.

10. Goodwill and Intangible Assets

On September 17, 2020, the Company acquired certain assets and assumed certain liabilities of CPN. This transaction was accounted for as a business combination in accordance with ASC Topic 805 Business Combinations. The Company recorded $3,377 of goodwill and $13,570 of intangible assets associated with this acquisition. Refer to Note “3. Acquisition” for detail.

Goodwill was $28,916$28,772 as of SeptemberJune 30, 20202021 and $25,539 as of December 31, 2019. There were no impairments recorded against goodwill during the three and nine months ended September 30, 2020 and 2019.

2020.

In April 2019, the Company purchased $750 of intangibles related to patent and know-how which were recorded within the developed technology category. The Company paid $250 at the time of the transaction with the remaining purchase price being paid over two years after the transaction closed. As of September 30, 2020, $250 was remaining and was recorded in accrued expenses and other current liabilities on the consolidated balance sheets.

Identifiable intangible assets consisted of the following as of SeptemberJune 30, 2020:

   Original
Cost
   Accumulated
Amortization
   Net Book
Value
 

Developed technology

  $32,620   $(13,503  $19,117 

Trade names and trademarks

   2,080    (828   1,252 

Customer relationships

   10,690    (45   10,645 

Non-compete agreements

   1,010    (175   835 
  

 

 

   

 

 

   

 

 

 

Total

  $46,400   $(14,551  $31,849 
  

 

 

   

 

 

   

 

 

 

2021:

   
Original
   
Accumulated
   
Net Book
 
   
Cost
   
Amortization
   
Value
 
Developed technology
  $32,620   $(16,020  $16,600 
Trade names and trademarks
   2,080    (1,056   1,024 
Customer relationships
   10,690    (846   9,844 
Non-compete
agreements
   1,010    (342   668 
   
 
 
   
 
 
   
 
 
 
Total
  $46,400   $(18,264  $28,136 
   
 
 
   
 
 
   
 
 
 
Identifiable intangible assets consisted of the following as of December 31, 2019:

   Original
Cost
   Accumulated
Amortization
   Net Book
Value
 

Developed technology

  $30,570   $(11,266  $19,304 

Trade names and trademarks

   2,000    (650   1,350 

Non-compete agreements

   260    (117   143 
  

 

 

   

 

 

   

 

 

 

Total

  $32,830   $(12,033  $20,797 
  

 

 

   

 

 

   

 

 

 

2020:

   
Original
   
Accumulated
   
Net Book
 
   
Cost
   
Amortization
   
Value
 
Developed technology
  $32,620   $(14,330  $18,290 
Trade names and trademarks
   2,080    (906   1,174 
Customer relationship
   10,690    (312   10,378 
Non-compete
agreements
   1,010    (230   780 
   
 
 
   
 
 
   
 
 
 
Total
  $46,400   $(15,778  $30,622 
   
 
 
   
 
 
   
 
 
 
Amortization of intangible assets, calculated on a straight-line basis or using an accelerated method, was $885$1,243 and $1,529$816 for the three months ended SeptemberJune 30, 20202021 and 2019,2020, respectively, and $2,518$2,486 and $4,526$1,633 for the ninesix months ended SeptemberJune 30, 2021 and 2020, and 2019, respectively.

10.

14

Table of Contents
11. Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consisted of the following:

   September 30,
2020
   December 31,
2019
 

Accrued personnel costs

  $21,158   $17,640 

Other

   4,974    5,810 
  

 

 

   

 

 

 
  $26,132   $23,450 
  

 

 

   

 

 

 

11.

   
June 30,
   
December 31,
 
  
 
2021
  
2020
 
 
Personnel costs  $    22,024   $18,943 
Royalties   2,718    2,971 
Other
   1,876    2,059 
   
 
 
   
 
 
 
   $26,618   $23,973 
           
12. Restructuring
On October 21, 2020, the Company committed to a plan to restructure the workforce and consolidate its La Jolla facilities as part of the Company’s long-term plan to consolidate manufacturing operations in Massachusetts to reduce the Company’s cost structure. The majority of the restructuring costs are expected to be incurred by the end of 2021, with certain facility and storage costs continuing through the middle of
2024
. The restructuring will result in a charge of approximately $7.0 million, of which approximately $4.5 million is attributable to the retention benefits associated with approximately 70 employees and the remaining $2.5 million is related to the facility closures. As employees are required to provide future services, employee retention and other benefit-related costs related to the Company’s restructuring are expensed over the service period.
As a result of this restructuring activity, the Company incurred
a pre-tax charge
of $939 and $1,866 during the three and six months ended June 30, 2021. This charge was primarily related to employee retention benefits and was included in selling, general and administrative expenses in the consolidated statements of operations. The liability related to the restructuring activities was $2,410 as of June 30, 2021 and was included in accrued expenses and other current liabilities in the consolidated balance sheets. The following table provides a roll-forward of the restructuring liability.
   
Employee
   
Facility
 
Liability balance as of March 31, 2021
  $1,528   $17 
Expenses
   853    86 
Payments
   0      (74
   
 
 
   
 
 
 
Liability balance as of June 30, 2021
  $2,381   $29 
   
 
 
   
 
 
 
   
   
Employee
   
Facility
 
Liability balance as of December 31, 2020
  $618   $0   
Expenses
   1,763    103 
Payments
   0      (74
   
 
 
   
 
 
 
Liability balance as of June 30, 2021
  $ 2,381   $   29 
   
 
 
   
 
 
 
13. Long-Term Debt
Obligations

Long-term debt obligations consisted of the following:

   September 30,
2020
   December 31,
2019
 

Line of credit

  $39,353   $33,484 
  

 

 

   

 

 

 

Term loan

   60,000    50,000 

Less debt discount and debt issuance cost

   (334   (366

Less current maturities

   (11,667   —   
  

 

 

   

 

 

 

Term loan, net of debt discount, debt issuance cost and current maturities

  $47,999   $49,634 
  

 

 

   

 

 

 

         
   
June 30,

2021
   
December 31,
2020
 
Line of credit
  $    10,000   $    10,000 
   
 
 
   
 
 
 
Term loan
   60,000    60,000 
Less debt discount and debt issuance cost
   (210   (290
Less current maturities
   (22,500   (16,666
   
 
 
   
 
 
 
Term loan, net of debt discount, debt issuance cost and current maturities
  $37,290   $43,044 
   
 
 
   
 
 
 
15

2019 Credit Agreement

In March 2019, the Company, its subsidiaries and Silicon Valley Bank (“SVB”), and the several other lenders thereto (collectively, the “Lenders”) entered into a credit agreement, as amended (the “2019 Credit Agreement”), providing for a term loan (the “Term Loan Facility”) and a revolving credit facility (the “Revolving Facility”) in an aggregate principal amount of $100,000. Capitalized terms used herein and not otherwise defined are defined as set forth in the 2019 Credit Agreement.

The Term Loan Facility is structured in three tranches, as follows: (i) the first tranche of $40,000 was made available to the Company and fully funded on March 14, 2019; (ii) the second tranche of $10,000 was made available to the Company and fully funded in September 2019 upon achievement of certain financial metrics; and (iii) the third tranche of $10,000 was made available to the Company and fully funded in March 2020 upon achievement of a certain financial metric. The interest rate for the Term Loan Facility is a floating per annum interest rate equal to the greater of 3.75% above the Wall Street Journal Prime Rate and 9.25%. The interest rate as of SeptemberJune 30, 20202021 was 9.25%. The 2019 Credit Agreement requires the Company to make monthly interest-only payments on outstanding balances under the Term Loan Facility through FebruaryJune 2021. Thereafter, each term loan advance will beis repaid inthirty-six

thirty-two
equal monthly installments of principal, plus accrued interest, with the Term Loan Facility maturing on MarchFebruary 1, 2024 (the “Term Loan Maturity Date”).

The Company’s final payment on the Term Loan Facility, due on the Term Loan Maturity Date, will include all outstanding principal and accrued and unpaid interest under the Term Loan Facility, plus a final payment (the “Final Payment”) equal to the original aggregate principal amount of the Term Loan Facility multiplied by 6.5%. The Company may prepay the Term Loan Facility, subject to paying the Prepayment Premium (described below) and the Final Payment. The Prepayment Premium is equal to 2.50% of the outstanding principal amount of the Term Loan Facility if the prepayment occurs after the one year anniversary and prior to the second anniversary of the closing, and 1.50% of the outstanding principal amount of the Term Loan Facility if the prepayment occurs after the two year
two-year
anniversary but prior to the three yearthree-year anniversary of the closing, and 0.50% thereafter. Once repaid, amounts borrowed under the Term Loan Facility may not be
re-borrowed.

The Revolving Facility is equal to the lesser of $40,000 and the amount determined by the Borrowing Base, which is defined as a percentage of the Company’s book value of qualifying finished goods inventory and eligible accounts receivable. The interest rate for advances under the Revolving Facility is a floating per annum interest rate equal to the greater of the Wall Street Journal Prime Rate and 5.50%. The interest rate as of SeptemberJune 30, 20202021 was 5.50%. If the actual outstanding advances are less than 25% of the then-available Revolving Commitments, the Company must pay monthly interest equal to the interest that would have accrued if the average outstanding advances had been 25% of the then-available Revolving Commitments. The Company is also required to pay an unused line fee equal to 0.25% per annum, calculated based on the difference of $40,000
minus
the greater of (i) the average balance outstanding under the Revolving Facility for such period and (ii) 25% of the then-available Revolving Commitments. The maturity date for advances made under the Revolving Facility is March 1, 2024.

The Company may elect to reduce or terminate the Revolving Facility in its entirety at any time by repaying all outstanding principal, unpaid accrued interest and a reduction or termination fee equal to 3.00% of the aggregate Revolving Commitments so reduced or terminated if the reduction or termination occurs after the one year anniversary and prior to the second anniversary of the closing, and 2.00% of the aggregate Revolving Commitments so reduced or terminated if the reduction or termination occurs after the two year anniversary but prior to the three year anniversary of the closing, and $0 thereafter.

The Company is required to achieve certain financial covenants under the 2019 Credit Agreement, including Minimum Trailing Twelve Month Consolidated Revenue and
Non-PuraPly
Revenue, tested quarterly. The Minimum Trailing Twelve Month Consolidated Revenue thresholds for the year ending December 31, 2020 were agreed to and the covenant requiring Trailing Twelve Month Non-PuraPly Revenue beginning with the quarter ending September 30, 2020 was added in connection with the third amendment to the 2019 Credit Agreement entered into on March 26, 2020. In addition, the Company is required to maintain Minimum Liquidity equal to the greater of (i) 6 months Monthly Burn and (ii) $10,000.

As of SeptemberJune 30, 2020, the Company was in compliance with the financial covenants under the 2019 Credit Agreement.

As of September 30, 2020,2021, the Company had outstanding borrowings of $60,000 under the Term Loan Facility and $39,353$10,000 under the Revolving Facility with $0up to $30,000 available (subject to Borrowing Base) for future revolving borrowings. The Company accrues for the Final Payment of $3,900 over the term of the Term Loan Facility through a charge to the interest expense. The related liability of $1,541$2,416 and $681$1,858 as of SeptemberJune 30, 20202021 and December 31, 2019,2020, respectively, was included in other liabilities on the consolidated balance sheets. The Company incurred costs of $554 in connection with the Term Loan Facility, which are recorded as a reduction of the carrying value of the term loan on the Company’s consolidated balance sheets. In connection with the Revolving Facility, the Company incurred costs of $370, which are recorded as other assets. Both of these costs are being amortized to interest expense through March 1, 2024.

the maturity date of the facilities.

Future payments of the 2019 Credit Agreement, as of SeptemberJune 30, 2020,2021, are as follows for the calendar years ending December 31:

2020

  $—   

2021

   16,667 

2022

   20,000 

2023

   20,000 

2024

   42,686 
  

 

 

 

Total

  $99,353 
  

 

 

 

2017 Credit Agreement

On March 21, 2017, the Company entered into a credit agreement (the “2017 Credit Agreement”) with SVB whereby SVB agreed to extend to the Company a revolving credit facility in an aggregate amount not to exceed $30,000 with a letter

2021
  $11,250 
2022
   22,500 
2023
   22,500 
2024
   13,750 
   
 
 
 
Total
  $70,000 
   
 
 
 
16

Table of credit sub-facility and a swing line sub-facility as a sublimitContents
14. Stockholders’ Equity
Common Stock
As of the revolving loan facility. In April 2018, the Company further amended its 2017 Credit Agreement in order to receive additional funding of $5,000 through a term loan. The amendment increased the commitment under the 2017 Credit Agreement to an aggregate amount not to exceed $35,000, consisting of a term loan not to exceed $5,000 and a revolving loan not to exceed $30,000. In December 2018, the Company fully repaid and canceled the term loan including the outstanding principal and accrued and unpaid interest.

On March 14, 2019, $26,541, representing all outstanding unpaid principal and accrued interest relating to the revolving borrowing due under the 2017 Credit Agreement, was rolled into the 2019 Credit Agreement.

Master Lease Agreement

On April 28, 2017, the Company entered into the Master Lease Agreement (the “ML Agreement”) with Eastward Fund Management LLC that allowed the Company to borrow up to $20,000 on or prior to June 30, 2018. If the Company elected to prepay the loan or terminated the loan early within the first 24 months, the Company was required to pay an additional 3% of the outstanding principal and any accrued and unpaid interest and fees. This prepayment fee decreased to 2% after the first 24 months. A final payment fee of 6.5% multiplied by the principal amount of the borrowings under the ML Agreement was due upon the earlier to occur of the first day of the final payment term month or prepayment of all outstanding principal. In March 2019, upon entering into the 2019 Credit Agreement, the Company paid an aggregate amount of $17,649 due under the ML Agreement, including unpaid principal, accrued interest, final payment, and early termination penalty, with proceeds from the 2019 Credit Agreement, and the ML Agreement was terminated. Upon termination of the ML Agreement, the Company recognized $1,862 as loss on the extinguishment of the loan.

12. Stockholders’ Equity

Common Stock

As of September 30, 2020,2021, the Company was authorized to issue 400,000,000 shares of $0.0001 par value Class A common stock and 1,000,000 shares of $0.0001 par value preferred stock. 108,185,702129,011,789 shares of Class A common stock were issued and 128,283,241 shares were outstanding as of SeptemberJune 30, 2020, which included 728,5482021. NaNshares of preferred stock were outstanding as of June 30, 2021. The issued shares of treasury stock. TheseClass A common stock include 728,548 treasury shares that were initially issuedreacquired in connection with the acquisitionredemption of Nutech Medical, Inc. (“NuTech Medical”)redeemable shares in 2017 and included a put right. The holders of the shares exercised the right to put the shares back to the Company at an agreed-upon exercise price of $9.28 per share on March 24, 2019.

As of SeptemberJune 30, 20202021 and December 31, 2019,2020, the Company reserved the following shares of Class A common stock for future issuance:

   September 30,
2020
   December 31,
2019
 

Shares reserved for issuance for outstanding options

   6,788,655    6,503,646 

Shares reserved for issuance for outstanding restricted stock units

   819,248    —   

Shares reserved for issuance for future grants

   6,819,449    9,008,996 
  

 

 

   

 

 

 

Total shares of authorized common stock reserved for future issuance

   14,427,352    15,512,642 
  

 

 

   

 

 

 

Warrant Exchange and Warrant Exercise

In the third quarter of 2019, the Company executed a series of transactions related to its then outstanding 30,890,748 public warrants and 4,100,000 private placement warrants. The Company issued an aggregate of 2,845,280 shares of Class A common stock for 29,950,150 public warrants at an exchange rate of 0.095. The Company issued an aggregate of 80,451 shares of Class A common stock for the remaining public warrants at an exchange rate of 0.0855. The Company issued an aggregate of 389,501 shares of Class A common stock for the private placement warrants at an exchange rate of 0.095.

On August 13, 2019, Massachusetts Capital Resource Company and Life Insurance Community Investment Initiative, LLC net exercised outstanding warrants to purchase an aggregate of 182,700 shares of the Company’s Class A common stock at an exercise price of $3.95 per share. The Company issued an aggregate of 19,426 shares of common stock in connection with this transaction.

As a result of these transactions, the Company issued an aggregate of 3,334,658 shares of common stock, representing approximately 3% of the total Class A common stock outstanding after such issuances. No warrants were outstanding after these transactions.

As the fair value of the warrants exchanged in the warrant exchange transactions immediately prior to the exchanges was less than the fair value of the common stock issued, the Company recorded a non-cash deemed dividend of $0.6 million for the incremental fair value provided to the warrant holders in the three months ended September 30, 2019.

13.

   
June 30,
   
December 31,
 
   
2021
   
2020
 
Shares reserved for issuance for outstanding options
   7,070,008    6,425,040 
Shares reserved for issuance for outstanding restricted stock units
   787,023    806,048 
Shares reserved for issuance for future grants
   5,642,864    6,832,649 
   
 
 
   
 
 
 
   
Total shares of authorized common stock reserved for future issuance
   13,499,895    14,063,737 
   
 
 
   
 
 
 
15. Stock-Based Compensation

Stock Incentive
Plans-the
2018 Plan

On November 28, 2018, the Board of Directors of the Company adopted, and on December 10, 2018 the Company’s stockholders approved, the Organogenesis 2018 Equity and Incentive Plan (the “2018 Plan”). The purposes of the 2018 Plan are to provide long-term incentives and rewards to the Company’s employees, officers, directors and other key persons (including consultants), to attract and retain persons with the requisite experience and ability, and to more closely align the interests of such employees, officers, directors and other key persons with the interests of the Company’s stockholders.

The 2018 Plan authorizes the Company’s Board of Directors or a committee of not less than two independent directors (in either case, the “Administrator”) to grant the following types of awards:
non-statutory
stock options; incentive stock options; restricted stock awards; restricted stock units; stock appreciation rights; unrestricted stock awards; performance share awards; and dividend equivalent rights. The 2018 Plan is administered by the Company’s Board of Directors.

As of SeptemberJune 30, 2020,2021, a total of 9,198,996 shares of Class A common stock have been authorized to be issued under the 2018 Plan (subject to adjustment in the case of any stock dividend, stock split, reverse stock split, or similar change in capitalization of the Company).

Stock Incentive
Plans-the
2003 Plan

The Organogenesis 2003 Stock Incentive Plan (the “2003 Plan”), provides for the Company to issue restricted stock awards, or to grant incentive stock options or
non-statutory
stock options. Incentive stock options may be granted only to the Company’s employees. Restricted stock awards and
non-statutory
stock options may be granted to employees, members of the Board of Directors, outside advisors and consultants of the Company.

Effective as of the closing of the Avista Merger on December 10, 2018, no additional awards may be made under the 2003 Plan and as a result (i) any shares in respect of stock options that are expired or terminated under the 2003 Plan without having been fully exercised will not be available for future awards; (ii) any shares in respect of restricted stock that are forfeited to, or otherwise repurchased by the Company, will not be available for future awards; and (iii) any shares of common stock that are tendered to the Company by a participant to exercise an award will not be available for future awards.

Following the closing of the Avista Merger, the 2003 Plan is administered by the Company’s Board of Directors.

Stock-Based
Compensation Expense

Stock options awarded under the stock incentive plans expire 10 years after the grant date and typically vest over four or five years. Restricted stock units awarded typically vest over four years.

Stock-based compensation expense was $486$1,042 and $242$469 for the three months ended SeptemberJune 30, 20202021 and 2019,2020, respectively, and was $1,164$1,740 and $700$678 for the ninesix months ended SeptemberJune 30, 20202021 and 2019,2020, respectively. The total amount of stock-based compensation expense was included within selling, general and administrative expenses on the consolidated statements of operations.

17

Restricted Stock Units (RSUs)

In the ninesix months ended SeptemberJune 30, 2020,2021, the Company granted 873,595290,027 time-based restricted stock units to its employees, executives and the Board of Directors. Each restricted stock unit represents the contingent right to receive one share of the Company’s common stock. A majority of the restricted stock units will vest in four equal annual installments in 2021, 2022, 2023 and 2024.installments. The fair value of the restricted stock units was based on the fair market value of the Company’s stock on the date of grant.

The activity of restricted stock units is set forth below:

   Number
of Shares
   Weighted
Average
Grant Date
Fair Value
 

Unvested at December 31, 2019

   —     $—   

Granted

   873,595    3.81 

Vested

   —      —   

Canceled/Forfeited

   (54,347   3.69 
  

 

 

   

 

 

 

Unvested at September 30, 2020

   819,248   $3.82 
  

 

 

   

 

 

 

   
Number

of Shares
   
Weighted
Average

Grant Date

Fair Value
 
Unvested at December 31, 2020
   806,048   $3.82 
Granted
   290,027    14.45 
Vested
   (252,743   4.20 
Canceled/Forfeited
   (56,309   8.29 
   
 
 
   
 
 
 
Unvested at June 30, 2021
   787,023   $7.30 
   
 
 
   
 
 
 
As of SeptemberJune 30, 2020,2021, the total unrecognized compensation cost related to unvested restricted stock units expected to vest was $1,977$3,891 and the weighted average remaining recognition period for unvested awards was 3.213.16 years.

Stock Option Valuation

The stock options granted during the ninesix months ended SeptemberJune 30, 2021 and 2020 were 1,037,099 and 2019 were 1,553,723 and 100,0001,538,723 respectively. The assumptions that the Company used to determine the grant-date fair value of stock options granted during these periods were as follows, presented on a weighted-average basis:

   September 30,
2020
  September 30,
2019
 

Risk-free interest rate

   0.46  2.24

Expected term (in years)

   6.22   6.50 

Expected volatility

   37.42  42.7

Expected dividend yield

   0.0  0.0

Exercise price

  $4.04  $7.08 

Underlying stock price

  $3.37  $7.08 

   
June 30,

2021
  
June 30,

2020
 
Risk-free interest rate
   0.82  0.46
Expected term (in years)
   6.21   6.22 
Expected volatility
   39.30  37.41
Expected dividend yield
   0.0  0.0
Exercise price
  $13.54  $4.04 
Underlying stock price
  $13.54  $3.36 
18

These assumptions resulted in an estimated weighted-average grant-date fair value per share of stock options granted during the ninesix months ended SeptemberJune 30, 2021 and 2020 of $5.31 and 2019 of $1.05 and $3.24,$1.04, respectively.

Stock Option Activity

The following table summarizes the Company’s stock option activity since December 31, 2019:

           Weighted     
           Average     
       Weighted   Remaining     
       Average   Contractual   Aggregate 
   Number of   Exercise   Term   Intrinsic 
   Shares   Price   (in years)   Value 

Outstanding as of December 31, 2019

   7,179,636   $1.98    5.06   $20,799 

Granted

   1,553,723    4.04     

Exercised

   (638,315   2.02      1,623 

Canceled / forfeited

   (630,399   3.64     
  

 

 

       

Outstanding as of September 30, 2020

   7,464,645    2.27    5.53    12,855 
  

 

 

       

Options exercisable as of September 30, 2020

   5,512,393    1.60    4.20    12,701 
  

 

 

       

Options vested or expected to vest as of September 30, 2020

   7,062,928   $2.16    5.30   $12,835 
  

 

 

       

2020:

   
Number of

Shares
   
Weighted

Average

Exercise

Price
   
Weighted

Average

Remaining

Contractual

Term

(in years)
   
Aggregate

Intrinsic

Value
 
Outstanding as of December 31, 2020
   6,620,318   $2.33    5.22   $34,458 
Granted
   1,037,099    13.54           
Exercised
   (558,785   2.15         5,526 
Canceled / forfeited
   (28,624   9.54           
   
 
 
                
Outstanding as of June 30, 2021
   7,070,008    3.95    5.56    89,543 
   
 
 
                
Options exercisable as of June 30, 2021
   4,709,080    1.83    3.91    69,665 
   
 
 
                
Options vested or expected to vest as of June 30, 2021
   6,557,753   $3.57    5.28   $85,578 
   
 
 
                
The aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the stock options and the fair value of the Company’s Class A common stock for those stock options that have exercise prices lower than the fair value of the Company’s Class A common stock.

The total fair value of options vested during the ninesix months ended SeptemberJune 30, 2021 and 2020 was $586 and 2019 was $387 and $538,$209, respectively.

As of SeptemberJune 30, 2020,2021, the total unrecognized stock compensation expense related to unvested stock options expected to vest was $1,598$4,676 and was expected to be recognized over a weighted-average period of 2.903.27 years.

As of September 30, 2020,

Between 2010 and 2013, a former executive took several partial recourse notes were outstanding totaling $635. These notes were taken by a former executive$635 to exercise his 675,990 shares of stock options between 2011 and 2013 and theoptions. The notes were initially secured with the 675,990these shares held by the former executive. When the loans were outstanding, the options were not considered exercised and were included within the options outstanding for accounting purposes. As of December 31, 2020, $334 of the principal balance of the partial recourse notes are stillwas outstanding the options are not considered exercised and are included within the options outstanding. Accordingly, the 675,990195,278 shares arewere not considered outstanding for accounting purposes and the additional paid-in capital associated with these shares were deducted from equity in prior periods.purposes. In the three months ended September 30, 2020,March 31, 2021, the former executive sold 25,096repaid the remaining principal balance of the notes (see Note “19. Related Parties Transactions”). The repayments were treated as the exercise price for 195,278 shares of the options and were included in the consolidated statement of stockholders’ equity. As of
June
30
, 2021,
0
ne
of the partial recourse notes was outstanding and all of the 675,990 shares used to pay back a portion of his nonrecourse notes. see Note “16. Related Parties Transactions”.

14.secure the notes were considered outstanding for accounting purposes.

16. Net Income (Loss) per Share (EPS)

Basic EPS is calculated by dividing net income (loss) by the weighted-average number of shares outstanding during the period. Diluted EPS is calculated by dividing net income (loss) by the weighted-average number of shares outstanding plus the dilutive effect, if any, of outstanding RSUs and optionsequity awards using the treasury stock method. The calculation of the dilutive effect of outstanding equity awards under the treasury stock method which includes consideration of unrecognized compensation expenses as additional proceeds.

19

Table of Contents
A reconciliation of the numerator and denominator used in the calculation of the basic and diluted net income (loss) attributable to the common stockholders of Organogenesis Holdings Inc. is as follows.

   Three Months Ended
September 30,
  Nine Months Ended
September 30,
 
Calculation of Basic and Diluted EPS  2020   2019  2020  2019 

Weighted-average common shares outstanding—basic

   105,040,035    92,276,858   104,748,297   91,182,233 

Dilutive effect of restricted stock units

   134,759    —     —     —   

Dilutive effect of options

   3,314,974    —     —     —   
  

 

 

   

 

 

  

 

 

  

 

 

 

Weighted-average common shares outstanding—diluted

   108,489,768    92,276,858   104,748,297   91,182,233 

Earnings (loss) per share—basic

  $0.20   $(0.12 $(0.01 $(0.40

Earnings (loss) per share—diluted

  $0.19   $(0.12 $(0.01 $(0.40

   
Three Months Ended June 30,
   
Six Months Ended June 30,
 
   
2021
   
2020
   
2021
   
2020
 
Numerator:
                    
Net Income (loss)
  $20,687   $(5,166  $30,630   $(21,479
Denominator:
                    
Weighted average common shares outstanding—basic   128,235,224    104,714,725    128,053,654    104,600,825 
Dilutive effect of restricted stock units
   508,015    —      517,837    —   
Dilutive effect of options
   5,245,174    —      5,149,700    —   
   
 
 
   
 
 
   
 
 
   
 
 
 
Weighted-average common shares outstanding—diluted
   133,988,413    104,714,725    133,721,191    104,600,825 
Earnings (loss) per share—basic
  $0.16   $(0.05  $0.24   $(0.21
   
 
 
   
 
 
   
 
 
   
 
 
 
Earnings (loss) per share—diluted
  $0.15   $(0.05  $0.23   $(0.21
   
 
 
   
 
 
   
 
 
   
 
 
 
For the
three and six months ended SeptemberJune 30, 2020,2021, outstanding stock-based awards of 2,009,245923,907 and 967,146 were excluded from the diluted EPS calculation. TheFor the three and six months ended June 30, 2020, the Company had a net loss in the other periods presented.loss. As such, the8,695,401 shares of potentially dilutive securities have beenwere excluded from the computation of diluted net loss per share as these securities havehad anti-dilutive effect and including them would reduce the net loss per share. Therefore, the weighted-average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders iswas the same for these periods. For
17. Leases
As of December 31, 2020 and June 30, 2021, the three months ended September 30, 2019,Company’s contracts that contained a lease consisted primarily of real estate, equipment and vehicle leases.
The Company leases real estate for office, lab and production space under noncancelable operating and finance leases that expire at various dates through 2031, subject to the Company’s options to terminate or renew certain leases for an additional five to ten years.
The Company leases vehicles under operating leases for certain employees and has fleet services agreements for service on these vehicles. The minimum lease term for each newly leased vehicle is 367 days with renewal options. The Company may terminate the vehicle lease after the minimum lease term upon thirty days’ prior notice.
The Company also leases other equipment under noncancelable operating and finance leases that expire at various dates through 2025.
The Company determines if an arrangement is a lease at lease inception. The options to extend or terminate a lease are included in the lease terms when it is reasonably certain that the Company excluded 7,263,990 potential shares of Class A common stock, presentedwill exercise the options. Operating leases are included in operating
lease right-of-use assets
and operating lease obligations on the consolidated balance sheets. Finance
lease right-of-use assets
are included in property and equipment, net, and the related liabilities are included in finance lease obligations on the consolidated balance sheets.
Right-of-use assets
represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the
leases. Right-of-use assets
and lease liabilities are recognized based on the present value of the fixed lease payments over the lease term at the commencement date.
The 
right
-of-use assets
also include any initial direct costs incurred and lease payments made at or before the commencement date and are reduced by lease incentives. The Company uses its incremental borrowing rate as the discount rate to determine the present value of the lease payments for leases that do not have a readily determinable implicit discount rate. The Company’s incremental borrowing rate is the rate of interest that it would have to borrow on a collateralized basis over a similar term and amount outstanding at this period end,in a similar economic environment. The Company determines the incremental borrowing rates for its leases by adjusting the risk-free interest rate with a credit risk premium corresponding to the Company’s credit rating.
20

The Company records rent expense for its operating leases on a straight-line basis from the computationlease commencement date until the end of diluted net loss per share attributablethe lease term. The Company records finance lease cost as a combination of the depreciation expense for
the right-of-use assets
and interest expense for the outstanding lease liabilities using the discount rate discussed above. Variable lease payments are primarily related to the office and fleet leases which include but are not limited to taxes, insurance, common stockholdersarea maintenance and maintenance programs for this period. Forleased vehicles. Variable lease payments are based on the nine months ended September 30,occurrence or usage; therefore, they are not included as part of the
initial right-of-use assets
and liabilities calculation.
In August 2020, and 2019, the Company excluded 8,283,893entered into a lease for approximately 23,000 square feet in San Diego, California for office and 7,263,990 potential shares of Class A common stock, respectively, presented based laboratory use. The lease
commenced
on amounts outstanding at each period end,April 1, 2021. The initial lease term is ten years from the computationlease commencement date, with an option to extend the term for a period of diluted net loss per share attributablefive years. Annual lease payments during the first year are $1,562 with 3% increase each year during the lease term. A security deposit of $237 is required throughout the term of the lease.
In conjunction with the acquisition of NuTech Medical in March 2017, the Company entered into an operating lease with Oxmoor Holdings, LLC, an entity that is affiliated with the former sole shareholder of NuTech Medical, related to the common stockholders for these periods.

15. Commitments and Contingencies

Capitalized Leases

facility at NuTech Medical’s headquarters in Birmingham, Alabama. Under the lease, the Company is required to make monthly rent payments of approximately $22 through the lease termination date on December 31, 2022.

On January 1, 2013, the Company entered into capitalfinance lease arrangements with 65 Dan Road SPE, LLC, 85 Dan Road Associates, LLC, Dan Road Equity I, LLC and 275 Dan Road SPE, LLC for office and laboratory space in Canton, Massachusetts. 65 Dan Road SPE, LLC, 85 Dan Road Associates, LLC, Dan Road Equity I, LLC and 275 Dan Road SPE, LLC are related parties as the owners of these entities are also stockholders of the Company. The leases terminate on December 31, 2022 and each contains a renewal option for a five-year period with the rental rate at the greater of (i) rent for the last year of the prior term, or (ii) the then fair market value. Notice of the exercise of this renewal option is due one year prior to the expiration of the initial term. Aggregate annual lease payments are approximately $4,308 with future rent increases of 10% effective January 1, 2022.

The Company records the capital lease asset within property and equipment and the liability is recorded within the capital lease obligations on the consolidated balance sheets.

As of SeptemberJune 30, 20202021 and December 31, 2019,2020, the Company owed an aggregate of $10,336 of accrued but unpaid lease obligations, which are subordinated to the 2019 Credit Agreement and will not be paid until the debt under the 2019 Credit Agreement is paid off in 2024 even though the capitalfinance leases expire in December 2022. The accrued but unpaid lease obligations include rent in arrears and unpaid operating and common area maintenance costs under the aforementioned leases. The principal portion of rent in arrears on the capitalfinance leases totaled $6,783$7,307 and $6,321$6,946 as of SeptemberJune 30, 20202021 and December 31, 2019,2020, respectively, and is included in the long-term portion of capitalfinance lease obligations. The interest portion of rent in arrears totaled $3,042$2,475 and $3,512$2,865 as of SeptemberJune 30, 20202021 and December 31, 2019,2020, respectively, and is included in other liabilities on the consolidated balance sheets. The unpaid operating and common area maintenance costs totaled $511$554 and $503$525 as of SeptemberJune 30, 20202021 and December 31, 2019,2020, respectively, and are included in other liabilities on the consolidated balance sheets.

Effective April 1, 2019, the Company agreed to accrue interest on the accrued but unpaid lease obligations at an interest rate equal to the rate charged in the 2019 Credit Agreement (see Note “11.“13. Long-Term Debt Obligations”). The accrued interest is also subordinated to the 2019 Credit Agreement and, as such, is included in other liabilities on the consolidated balance sheet. Interest accrual as of SeptemberJune 30, 20202021 and December 31, 20192020 totaled $1,434
$2,151 and $717,$1,673, respectively.

In addition to the capital leases with affiliates discussed above, the Company also has certain insignificant capital leases with non-affiliates. Future obligations under capital leases in the aggregate and for the next five years are

The components of lease cost were as follows:

2020 (remaining 3 months)

  $1,198 

2021

   4,786 

2022

   4,945 

2023

   —   

2024

   9,825 
  

 

 

 
   20,754 

Less amount representing interest

   (5,042
  

 

 

 

Present value of minimum lease payments

   15,712 

Less current maturities

   (3,473
  

 

 

 

Long-term portion

  $12,239 
  

 

 

 

Operating Leases

The Company leases vehicles for certain employees and has fleet services agreements for service on these vehicles. The minimum lease term for each newly leased vehicle is one year with three consecutive one-year renewal terms.

In March 2014, in conjunction with the acquisition

   
Classification
  
Three
 
Months
Ended
June 30,
 
2021
   
Six Months
Ended

June 30,
2021
 
Finance lease
             
Amortization of
right-of-use
assets
  COGS and SG&A  $        304   $603 
Interest on lease liabilities  Interest Expense   312    661 
      
 
 
   
 
 
 
Total Finance lease cost
      616    1,264 
Operating lease cost
  COGS, R&D, SG&A   1,735    3,015 
Short-term lease cost
  COGS, R&D, SG&A   699    1,414 
Variable lease cost
  COGS, R&D, SG&A   1,086    2,449 
      
 
 
   
 
 
 
Total lease cost     $4,136   $8,142 
      
 
 
   
 
 
 
21

Supplemental balance sheet information related to the facility at NuTech Medical’s headquarters in Birmingham, Alabama. finance leases was as follows:
   
June 30, 2021
   
January 1, 2021
 
Property and equipment, gross
  $22,989   $22,989 
Accumulated depreciation
   (15,578   (14,974
   
 
 
   
 
 
 
Property and equipment, net
  $7,411   $8,015 
   
 
 
   
 
 
 
   
Current portion of finance lease obligations
  $4,134   $3,619 
Finance lease long-term obligations
   9,553    11,442 
   
 
 
   
 
 
 
Total finance lease liabilities
  $13,687   $15,061 
   
 
 
   
 
 
 
Supplemental cash flow
information related to leases was as follows:
Six Months Ended
June 30, 2021
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows for operating leases
3,228
Operating cash flows for finance leases
1,022
Financing cash flows for finance leases
1,374
Right-of-use
assets obtained in exchange for lease obligations - upon adoption:
Operating leases
13,525
Finance leases
—  
Right-of-use
assets obtained in exchange for lease obligations - post adoption:
Operating leases
15,567
Finance leases
—  
June 30, 2021
Weighted-average remaining lease term
Finance leases
1.49
Operating leases
8.27
June 30, 2021
Weighted-average discount rate
Finance leases
19.69
Operating leases
4.19
22

As of June 30, 2021, maturities of lease liabilities were as follows:
   
Operating
 
leases
   
Finance leases
 
2021 (remaining 6 months)
  $        3,319   $2,390 
2022
   4,507    4,945 
2023
   3,845    0   
2024
   3,177    9,782 
2025
   3,164    0   
Thereafter
   16,341    0   
   
 
 
   
 
 
 
Total lease payments
   34,353    17,117 
Less: interest
   (5,625   (3,430
   
 
 
   
 
 
 
Total lease liabilities
  $28,728   $13,687 
   
 
 
   
 
 
 
Under the lease, the Company is required to make monthly rent payments of approximately $21 through the lease termination date on December 31, 2021.

In March 2019, the Company entered into an agreement to lease approximately 43,850 square feet of office and laboratory space in Norwood, Massachusetts. Pursuant to the lease agreement, the rent commencement date was February 1, 2020. The initial lease term is ten years from the rent commencement date and includes an option for an early extension term of five years which is exercisable during the first two years after the rent commencement date. In addition to the early extension term, the lease provides the Company with an option to extend the lease term for a period of ten years, if exercised, at rental rates equal to the then fair market value. Annual lease payments during the first year are $1,052 with increases of $44 each year during the initial ten-year lease term, an increase of $44 during the first year of the early extension term and $33 during year two through five of the early extension term. Upon execution of the agreement, the Company delivered a security deposit in the form of a letter of credit of $526 to the landlord. Following 36 months from the rent commencement date, the security deposit may be reduced by $263.

Operating lease expenses were $1,620 and $1,766ASC 840, for the three and six months ended SeptemberJune 30, 2020, the Company recorded lease expense of $1,837 and 2019,$3,351, respectively for operating leases.

18. Commitments and were $4,971 and $4,993 for the nine months ended September 30, 2020 and 2019, respectively.

Future minimum lease payments due under noncancelable operating lease agreements as of September 30, 2020 are as follows:

2020 (remaining 3 months)

  $1,250 

2021

   5,974 

2022

   3,471 

2023

   2,804 

2024

   1,224 

Thereafter

   6,899 
  

 

 

 
  $21,622 
  

 

 

 

Contingencies

Royalty Commitments

The Company entered into a license agreement with a university for certain patent rights related to the development, use, and production of one of its advanced wound care products. Under this agreement, the Company incurred a royalty based on a percentage of net product sales, for the use of these patents until the patents expired, which was in November 2006. Accrued royalties totaled $1,187 as of SeptemberJune 30, 20202021 and December 31, 2019,2020, respectively, and arewere classified as part of accrued expenses on the Company’s consolidated balance sheets. There was no0 royalty expense incurred during the three and ninesix months ended SeptemberJune 30, 20202021 or 20192020 related to this agreement.

In October 2017, the Company entered into a license agreement with a third party. Under the license agreement, the Company is required to pay royalties based on a percentage of net sales of the licensed product that occur, after December 31, 2017, through the expiration of the underlying patent in October 2026, subject to minimum royalty payment provisions. The Company recorded royalty expense of $1,201$1,134 and $991$839 during the three months ended SeptemberJune 30, 20202021 and 2019,2020, respectively, and $3,020$2,355 and $2,695$1,819 during the ninesix months ended SeptemberJune 30, 20202021 and 2019,2020, respectively, within selling, general and administrative expenses on the consolidated statement of operations.

As part of the NuTech Medical acquisition, the Company inherited certain product development and consulting agreements for ongoing consulting services and royalty payments based on a percentage of net sales on certain products over a period of 15 years from the execution of the agreements. These product development and consulting agreements were cancelled in January 2020 for total consideration of $1,950 that was paid on February 14, 2020. The $1,950 cancellation fee was recorded within selling, general and administrative expenses on the consolidated statement of operations for the ninesix months ended SeptemberJune 30, 2020.

Ransomware Attack

In August 2020, the Company’s information technology (“IT”) systems were exposed to a ransomware attack, which partially impaired certain IT systems for a short period of time. The Company is investigating the incident, together with legal counsel and other incident response professionals. The Company does not believe it has experienced a material loss related to the ransomware attack, and substantially all costs incurred to date are expected to be reimbursed by insurance.

Legal Proceedings

In conducting its activities, the Company, from time to time, is subject to various claims and also has claims against others. In management’s opinion, the ultimate resolution of such claims would not have a material effect on the financial position, operating results or cash flows of the Company. The Company accrues for these claims when amounts due are probable and estimable.

The Company accrued $158 and $542$150 as of SeptemberJune 30, 20202021 and December 31, 2019, respectively, in relation to 2020
for
certain pending lawsuits.

The purchase price for NuTech Medical acquired in 2017 included $7,500 deferred acquisition consideration of which the Company paid $2,500 in 2017. The remaining $5,000 of deferred acquisition consideration plus accrued interest owed to the sellers of NuTech Medical was previously in dispute. The Company asserted certain claims for indemnification that would offset in whole or in part its payment obligation and the sellers of NuTech Medical filed a lawsuit alleging breach of contract and seeking specific performance of the alleged payment obligation and attorneys’ fees. In February 2020, the Company entered into a settlement agreement with the sellers of NuTech Medical and settled the dispute for $4,000, of which, $2,000 was paid immediately on February 24, 2020 (the “Settlement Date”) and the remaining $2,000 is beingwas paid in four quarterly installments of $500 each witheach. As of March 31, 2021, the first quarterly payment due and payable on the date that is 90 days from the Settlement Date.entire settlement was paid off. In addition, the
Company assumed from the sellers of NuTech Medical the payment responsibilities related to a legacy lawsuit existing at the acquisition date of NuTech Medical. In connection with the settlement of this dispute, the Company recorded a gain of $1,295 for the three months ended March 31, 2020. The assumed legacy lawsuit was settled in October 20202020. In connection with the settlement of the deferred acquisition consideration dispute and the legacy lawsuit, the Company recorded a gain of $1,295 and $951 from the decrease in legal accrual for the three months ended March 31, 2020 and September 30, 2020. Both of the gains were2020, respectively.
The gain was included as a component of other expense, net, on the consolidated statement of operations.

16.

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19. Related Party
Transactions

Capital

Finance lease obligations to affiliates, including unpaid lease obligations, and an operating lease with affiliates are further described in Note “15. Commitments and Contingencies”“17. Leases”.

During 2010, the Company’s Board of Directors approved a loan program that permitted the Company to make loans to three executives of the Company (the “Employer Loans”) to (i) provide them with liquidity (“Liquidity Loans”) and (ii) fund the exercise of vested stock options (“Option Loans”). Two of the executives left the Company in 2014. The Employer Loans maturematured with all principal and accrued interest due on the tenth anniversary of the issuance date of each subject loan. The borrower may prepay all or any portion of his Employer Loan at any time without premium or penalty. Interest on the Employer Loans accrueswas at various rates ranging from 2.30%—3.86% per annum, compounded annually. The Employer Loans arewere secured by shares of the Company’s Class A common stock.stock held by the former executives. With respect to the Liquidity Loans, the Company hashad no personal recourse against the borrowers beyond the pledged shares.

As of September 30,December 31, 2020, Liquidity Loans and Option Loans to one former executive were outstanding with an aggregate principal balance of $297$100 and $635, respectively As of December 31, 2019, Liquidity Loans to two former executives were outstanding with an aggregate principal balance of $2,350 and Option Loans to one former executive were outstanding with an aggregate principal balance of $635. The principal and part of the interest receivable under the Employer Loans were fully reserved with net interest receivable of $0 and $556 as of September 30, 2020 and December 31, 2019, respectively, included in the notes receivable from related parties balance in the consolidated balance sheets. In$334, respectively. During the three months ended September 30, 2020, one of theMarch 31, 2021, this former executivesexecutive paid $1,000 ofoff the outstanding principal balance of his liquidity loansEmployer Loans and the related interest receivable. The Company forgave $1,000 of the remaining outstanding principal balance of his liquidity loans. The other former executive paid $53 of the outstanding principal balance of his liquidity loans and $58 of the related accrued interest. As a result, the Company recorded $1,111$179 as a recovery of the previously reserved related party receivables within selling, general and administrative expenses on the consolidated statement of operations for the threesix months ended SeptemberJune 30, 2021. The $334 of the repaid principal balance of the Option Loans was recorded to eq

uity.
See Note “15. Share-Based Compensation”
.
20. Taxes
The Company is principally subject to taxation in the United States. The Company has a history of net operating losses both federally and in various states and began utilizing those losses to offset current taxable income in 2020.

17. The Company’s wholly owned Swiss subsidiary, Organogenesis GmbH, is subject to taxation in Switzerland and generally has profits as a result of a transfer pricing arrangement in place with Organogenesis Inc., its U.S. parent and a wholly owned subsidiary of the Company.

The income tax rate for the six months ended June 30, 2021 varied from the U.S. statutory rate of 21% primarily due to the utilization of net operating losses federally and in many states as well as the cash taxes in Switzerland. The Company maintains a full valuation allowance against its U.S. deferred tax assets and as such, the Company’s provision for income taxes primarily relates to cash taxes to be paid in certain states where the net operating losses are expected to be fully utilized or limited based on state statute. Income tax expense for the six months ended June 30, 2021 was $687, which included discrete tax expense of $20 related to the interest on certain uncertain tax positions. Income tax expense for the six months ended June 30, 2020 was $62 and related primarily to state and foreign taxes.
The Company examines all positive and negative evidence to estimate whether sufficient future taxable income in the U.S. will be generated to permit the use of existing deferred tax assets. The Company has significant negative evidence in the form of cumulative losses and believes that it is more likely than not that these United States deferred tax assets will not be utilized. As such, the Company maintained the valuation allowance against its U.S. deferred tax asset as of June 30, 2021. There are no material deferred tax assets in the other jurisdictions.
 On a quarterly basis, the Company reassesses the valuation allowance on deferred income tax assets, weighing positive and negative evidence to assess the recoverability of the deferred tax assets. After assessing both the positive evidence and the negative evidence, the Company may determine it is more likely than not that the deferred tax assets would be realized in the future and the Company would therefore release all or a portion of the valuation allowance related to the net operating loss carryforwards and other deferred tax assets.
21. Subsequent Events

The Company has evaluated subsequent events through NovemberAugust 9, 2020,2021, the date on which these consolidated financial statements were issued.

On October 21, 2020,August 6, 2021, the Company, committedas borrower, its subsidiaries, as guarantors, and SVB, and the several other lenders entered into a credit agreement (the “2021 Credit Agreement”) providing for a term loan facility not to exceed $
75,000
and a planrevolving credit facility not to restructureexceed $
125,000
, both of which mature on
August 6, 2026
. On the workforcesame date, the Company paid all amount due under the 2019 Credit Agreement, including unpaid principal, accrued interest, Final Payment, and consolidate La Jolla facilities as partPrepayment Premium, and the 2019 Credit Agreement was terminated.

24


Table of the Company’s long-term plan to consolidate manufacturing operations in Massachusetts in order to reduce the Company’s cost structure. The restructuring is expected to result in a charge of approximately $5.5 million, which is primarily attributable to the retention benefits associated with approximately 75 employees.

Contents

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The following discussion and analysis should be read in conjunction with our financial statements and accompanying notes included in this Quarterly Report on Form
10-Q
and the 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, filed with the Securities and Exchange Commission, or SEC, on March 9, 2020,16, 2021, as amended. Please refer to our note regarding forward-looking statements on page 3 of this Form
10-Q,
which is incorporated herein by this reference.

Overview

Organogenesis is a leading regenerative medicine company focused on the development, manufacture, and commercialization of solutions for the Advanced Wound Care and Surgical & Sports Medicine markets. Our products have been shown through clinical and scientific studies to support and in some cases accelerate tissue healing and improve patient outcomes. We are advancing the standard of care in each phase of the healing process through multiple breakthroughs in tissue engineering and cell therapy. Our solutions address large and growing markets driven by aging demographics and increases in comorbidities such as diabetes, obesity, cardiovascular and peripheral vascular disease and smoking. We offer our differentiated products and
in-house
customer support to a wide range of health care customers including hospitals, wound care centers, government facilities, ambulatory service centers (“ASCs”), and physician offices. Our mission is to provide integrated healing solutions that substantially improve medical outcomes and the lives of patients while lowering the overall cost of care.

We offer a comprehensive portfolio of products in the markets we serve that address patient needs across the continuum of care. We have and intend to continue to generate data from clinical trials, real-world outcomes and health economics research that validate the clinical efficacy and value proposition offered by our products. Several of our existing and pipeline products in our portfolio have PMA approval, BLA approval or 510(k) clearance from the FDA. Given the extensive time and cost required to conduct clinical trials and receive FDA approvals, we believe that our data and regulatory approvals provide us a strong competitive advantage. Our product development expertise and multiple technology platforms provide a robust product pipeline, which we believe will drive future growth.

In the Advanced Wound Care market, we focus on the development and commercialization of advanced wound care products for the treatment of chronic and acute wounds primarily in the outpatient setting.various treatment settings. We have a comprehensive portfolio of regenerative medicine products, capable of supporting patients from early in the wound healing process through to wound closure regardless of wound type. Our Advanced Wound Care products include Apligraf for the treatment of venous leg ulcers (“VLUs”) and diabetic foot ulcers (“DFUs”); Dermagraft for the treatment of DFUs; PuraPly AM to address biofilm acrossand PuraPly XT as antimicrobial barriers for a broad variety of wound types; and the Affinity and NuShield wound coverings to address a variety of wound sizes and types. We have a highly trained and specialized direct wound care sales force paired with exceptional customer support services.

In the Surgical & Sports Medicine market, we focus on products that support the healing of musculoskeletal injuries, including degenerative conditions such as osteoarthritis and tendonitis. We are leveraging our regenerative medicine capabilities in this attractive, adjacent market. Our Surgical & Sports Medicine products include ReNu
for in-office joint and tendon applications; knee
osteoarthritis treatment; NuCel for bony fusion in the spine and extremities;lumbar spine; NuShield and Affinity barrier products for surgical application in targeted soft tissue repairs; and PuraPly AM for surgical treatmentmanagement of open wounds.wounds in the surgical setting. We currently sell these products through independent agencies and our growing direct sales force.

force other than ReNu and NuCel which we stopped marketing after May 31, 2021. Refer to further discussion in section “End of Enforcement Grace Period for ReNu and NuCel” below.

On December 10, 2018, Avista Healthcare Public Acquisition Corp., our predecessor company (“AHPAC”), consummated the previously announced
a
business combination pursuant to that certain Agreement and Plan of Merger, dated as of August 17, 2018 (as amended, the “Avista Merger Agreement”), by and among AHPAC, Avista Healthcare Merger Sub, Inc., a Delaware corporation and a direct wholly-owned subsidiary of AHPAC (“Avista Merger Sub”) and Organogenesis Inc., a Delaware corporation. As a result of the transactions contemplated by the Avista Merger Agreement, Avista Merger Sub merged with and into Organogenesis Inc., with Organogenesis Inc. surviving the merger (the “Avista Merger”). In addition, in connection with the business combination, AHPAC redomesticated as a Delaware corporation (the “Domestication”). After the Domestication, AHPAC changed its name to “Organogenesis Holdings Inc.” As a result of the Avista Merger, Organogenesis Inc. became a wholly-owned direct subsidiary of Organogenesis Holdings Inc.


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For the ninesix months ended SeptemberJune 30, 2020,2021, we generated $231.5$225.7 million of net revenue and had $0.5$30.6 million of net lossincome compared to $186.3$130.7 million of net revenue and $36.1$21.5 million of net loss for the ninesix months ended SeptemberJune 30, 2019.2020. We have incurred significant losses since inception and, while we have reported net income for the three monthsfour consecutive quarters ended SeptemberJune 30, 2020,2021, we may incur operating losses in the future as we expend resources as part of our efforts to grow our organization to support the planned expansion of our business. As of SeptemberJune 30, 2020,2021, we had an accumulated deficit of $171.6$120.1 million. Our primary sources of capital to date have been from sales of our products, borrowings from related parties and institutional lenders and proceeds from the sale of our common stock. We operate in one segment of regenerative medicine.

On March 11, 2020,

COVID-19 pandemic
The emergence of the World Health Organization declared
coronavirus (COVID-19) around
the outbreak of COVID-19 a pandemic,world, and the virus continues to spread throughoutparticularly in the United States, continues to present risks to the Company. While
the COVID-19 pandemic
has not materially adversely affected our financial results and business operations through the restsecond quarter ended June 30, 2021, we are unable to predict the impact
that COVID-19 will
have on our financial position and operating results because of the world. Various public and private sector measures have been taken and may continue to be taken to reduce its transmission, such asnumerous uncertainties created by the impositionunprecedented nature of social distancing, stay-at-home and shelter-in-place orders, which are having the effect of suspending or severely curtailing operations for most industries and businesses.pandemic. We are oneclosely monitoring the evolving impact of many companies providing essential services during this national emergency related to the COVID-19 pandemic.pandemic on all aspects of our business. We have implemented a number of measures designed to protect the health and safety of our employees, support our customers and promote business continuity. We have reviewed and implemented cost-saving measures and we will continue to review and implement additional cost-saving measures, as necessary. These measures have included discontinuing or delaying all non-essential services and programs, and instituting controls on travel, events, marketing and clinical studies to adapt our business plan for the evolving COVID-19 challenges.

While the COVID-19 pandemic has not materially adversely affected our financial results and business operations through the third quarter ended September 30, 2020, the pandemic may pose significant risks to our business. We cannot currently quantify the impact the continuing COVID-19 pandemic may have on our revenue for the remainder of our fiscal year ending December 31, 2020 or beyond, but the public health actions being undertaken to reduce the spread of the virus may create significant disruptions with respect to: (i) the demand for our products, (ii) the ability of our sales representatives to reach our healthcare customers, (iii) our ability to maintain staffing levels to support our operations, (iv) our ability to continue to manufacture certain of our products, (v) the reliability of our supply chain and (vi) our ability to achieve the financial covenants required under the 2019 Credit Agreement. Accordingly, management continues to evaluate the Company’s liquidity position, communicate with and monitor the actions of our customers and suppliers, and review our near-term financial performance as we manage the Company through this period of uncertainty. Please see “Item 1A. Risk Factors” in this Quarterly Report on Form 10-Q for an additional discussion of risks and potential risks of the COVID-19 pandemic on our business, financial condition and results of operations.

CPN Acquisition

On September 17, 2020, we acquired certain assets and assumed certain liabilities of CPN Biosciences, LLC (“CPN”) pursuant to an asset purchase agreement dated July 24, 2020. This transaction was accounted for as a business combination using the acquisition method of accounting in accordance with ASC Topic 805,
 Business Combinations
. The aggregated consideration amounted to $19.0 million as of the acquisition date which consisted of $6.4 million in cash, 2,151,438 shares of our common stock with a fair value of $8.8 million, and a contingent consideration (the “Earnout”) with a fair value of $3.8 million. At the closing, we paid $5.8 million in cash and issued 1,947,953 shares of our Class A common stock. The remaining consideration was held back and will be paid or issued, as applicable, eighteen months after the closing date, subject to any offsetting indemnification claims against CPN. The results of operations of CPN have been included in our consolidated financial statements beginning on the acquisition date. Revenue and expenses of CPN since the acquisition date were not material.

End of Enforcement Grace Period for ReNu and NuCel
On November 16, 2017, the FDA issued a final guidance document entitled, “Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use”, or 361 HCT/P Guidance, which provided the FDA’s thinking on how to apply the existing regulatory criteria for regulation as a Section 361 HCT/P. The 361 HCT/P Guidance clarified the FDA’s views about the criteria that differentiate those products subject to regulation under Section 361 of the Public Health Service Act from those considered to be drugs, devices, and/or biological products subject to licensure under Section 351 and related regulations. The 361 HCT/P Guidance originally indicated that the FDA was providing a
36-month
enforcement grace period to allow time for distributors of HCT/Ps to make any regulatory submissions and obtain any premarket approvals necessary to comply with the guidance. In July 2020, the FDA announced that the enforcement grace period would be extended until May 31, 2021 as a result of the challenges presented by the
COVID-19
public health emergency. On April 21, 2021, the FDA reaffirmed that the enforcement grace period would end on May 31, 2021 and would not be extended. At that time, the FDA began regulating our ReNu and NuCel products under Section 351. We continued to market our ReNu and NuCel products during the enforcement grace period, but we ceased commercial distribution after May 31, 2021. We are continuing to conduct clinical studies of ReNu to support FDA approval of a Biologics License Application for the treatment of knee osteoarthritis and, based on favorable feasibility studies, we believe ReNu has potential as a treatment for additional osteoarthritis and tissue regeneration applications. Accordingly, we have decided to focus on clinical development of ReNu and discontinue clinical development of NuCel.
Components of Our Consolidated Results of Operations

In assessing the performance of our business, we consider a variety of performance and financial measures. We believe the items discussed below provide insight into the factors that affect these key measures.

Revenue

We derive our net revenue from our portfolio of Advanced Wound Care and Surgical & Sports Medicine products. We primarily sell our Advanced Wound Care products through direct sales representatives who manage and maintain the sales relationships with hospitals, wound care centers, government facilities, ASCs and physician offices. We primarily sell our Surgical & Sports Medicine products through third party agencies. As of SeptemberJune 30, 2020,2021, we had approximately 295325 direct sales representatives and approximately 170185 independent agencies.

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We recognize revenue from sales of our Advanced Wound Care and Surgical & Sports Medicine products when the customer obtains control of our product, which occurs at a point in time and may be upon procedure date, shipment, or delivery, based on the contractual terms of a contract. We record revenue net of a reserve for returns, discounts and GPO rebates, which represent a direct reduction to the revenue we recognize.

Several factors affect our reported revenue in any period, including product, payer and geographic sales mix, operational effectiveness, pricing realization, marketing and promotional efforts, the timing of orders and shipments, regulatory actions including healthcare reimbursement scenarios, competition and business acquisitions.

Included within our product revenue isare our PuraPly product portfolio that consists of PuraPly and PuraPly AM.AM products. We launched PuraPly
in mid-2015, and
introduced PuraPly AM in 2016. In order to encourage the development of innovative medical devices, drugs and biologics, CMS can grant new products an additional “pass-through payment” in addition to the bundled payment amount for a limited period of no more than three years. Our PuraPly and PuraPly AM products were granted pass-through status from launch through December 31, 2017, which created an economic incentive for practitioners to use PuraPly and PuraPly AM over other skin substitutes. As a result, we saw increases in revenue related to our PuraPly portfoliothese products in the reported periods.2017. Beginning January 1, 2018, PuraPly AM and PuraPly transitioned to the bundled payment structure for skin substitutes, which provides for
two-tiered payment
system in the hospital outpatient and ASC setting.
The two-tiered Medicare
payment system bundles payment for our Advanced Wound Care products (and all skin substitutes) into the payment for the procedure for applying the skin substitute, resulting in a single payment to the provider that includes reimbursement for both the procedure and the product itself. As a result of the transition to the bundled payment structure, total Medicare reimbursement for procedures using our PuraPly AM and PuraPly products decreased substantially. This reduction in reimbursement resulted in a substantial decrease in revenue from our PuraPly AM and PuraPly products during the first nine months of 2018 and had a negative effect on our business, results of operations and financial condition. On March 23, 2018, Congress passed, and the President signed into law, the Consolidated Appropriations Act of 2018, or the Act. The Act restored the pass-through status of PuraPly and PuraPly AM effectivefrom October 1, 2018.2018 through September 30, 2020. As a result, effective October 1, 2018,during this period, Medicare resumed making pass-through payments to hospitals using PuraPly and PuraPly AM in the outpatient hospital setting and in ASCs. PuraPly and PuraPly AM hadWith the expiration of pass-through reimbursement status through September 30, 2020. Afteron September 30, 2020, we expectanticipated that our net revenue from PuraPly and PuraPly AM willmight decrease as they transitiontransitioned to the bundled payment structure. WhileAs of June 30, 2021, we expect our net revenue from Non-PuraPly products will continue to increase, we cannot be certain that anyhave not observed such revenue increase will fully offset the revenuea decrease from PuraPly products. We are not able to estimate the extent of the changes in revenueprimarily due to the uncertainties related to the impact from the COVID-19 pandemic, which could have material adverse effects on our revenue, especially to the extent that the pandemic persists or exacerbates over an extended period of time.

recently launched PuraPly line extensions.

Cost of goods sold, gross profit and gross profit margin

Cost of goods sold includes personnel costs, product testing costs, quality assurance costs, raw materials and product costs, manufacturing costs, and the costs associated with our manufacturing and warehouse facilities. The increases in our cost of goods sold correspond with the increases in sales units driven by the expansion of our sales force and sales territories, expansion of our product portfolio offerings, and the number of healthcare facilities that offer our products.

We expect our cost of goods sold to increase due primarily to increased sales volumes.

Gross profit is calculated as net revenue less cost of goods sold and generally increases as revenue increases. Gross profit margin is calculated as gross profit divided by total net revenue. Our gross profit and gross profit margin are affected by product and geographic sales mix, realized pricing of our products, the efficiency of our manufacturing operations and the costs of materials used and fees charged by third-party manufacturers to produce our products. Regulatory actions, including healthcare reimbursement scenarios, which may require costly expenditures or result in pricing pressures, may decrease our gross profit and gross profit margin.

Selling, general and administrative expenses

Selling, general and administrative expenses generally include personnel costs for sales, marketing, sales support, customer support, and general and administrative personnel, sales commissions, incentive compensation, insurance, professional fees, depreciation, amortization, bad debt expense, royalties, information systems costs and costs associated with our administrative facilities. We generally expect our selling, general and administrative expenses to continue to increase due to increased investments in market development and the geographic expansion of our sales forces as we drive for continued revenue growth.

Research and development expenses

Research and development expenses include personnel costs for our research and development personnel, expenses related to improvements in our manufacturing processes, enhancements to our currently available products, and additional investments in our product and platform development pipeline. Our research and development expenses also include expenses for clinical trials. We expense research and development costs as incurred. We generally expect that research and development expenses will increase as we continue to conduct clinical trials on new and existing products, move
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products through the regulatory pathway (e.g., seek BLA approval), add personnel to support product enhancements as well as to bring new products to market, and enhance our manufacturing process and procedures.

Other expense, net

Interest expense, net
—Interest expense, net consists of interest on our outstanding indebtedness, including amortization of debt discount and debt issuance costs, net of interest income recognized.

Loss on the extinguishment of debt—In March 2019, upon entering into the 2019 Credit Agreement, we paid an aggregate amount of $17.6 million associated with the termination of the ML Agreement, including unpaid principal, accrued interest and an early termination penalty. We recognized $1.9 million as loss on the extinguishment of the loan for the nine months ended September 30, 2019.

Gain on settlement of deferreddeferr
ed acquisition consideration
—In February 2020, we settled the dispute on the $5.0 million deferred purchase acquisition consideration with the sellers of NuTech Medical for $4.0 million and assumed from the sellers of NuTech Medical the responsibilities related to a legacy lawsuit of NuTech Medical.Medical, which was settled in October 2020. In connection with the settlement of this dispute and the legacy lawsuit, we recorded a gain of $1.3 million and $1.0 million for the three months ended March 31, 2020. The assumed legacy lawsuit was settled in October 2020 and we recorded a gain of $1.0 million from the decrease in legal accrual for the three months ended September 30, 2020.

December 31, 2020, respectively.

Income taxes

We account for income taxes using an asset and liability approach. Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Valuation allowances are provided when necessary to reduce net deferred tax assets to an amount that is more likely than not to be realized.

In determining whether a valuation allowance for deferred tax assets is necessary, we analyze both positive and negative evidence related to the realization of deferred tax assets and inherent in that, assess the likelihood of sufficient future taxable income. We also consider the expected reversal of deferred tax liabilities and analyze the period in which these liabilities would be expected to reverse to determine whether the taxable temporary difference amounts serve as an adequate source of future taxable income to support realizability of the deferred tax assets. In addition, we consider whether it is more likely than not that the tax position will be sustained on examination by taxing authorities based on the technical merits of the position. Based on a consideration of the factors discussed above, including the fact that through the period ended SeptemberJune 30, 2020,2021, our results reflected a three-yeartwelve-quarter cumulative loss position, we have determined that a valuation allowance is necessary against the full amount of our net U.S. deferred tax assets, excluding alternative minimumassets. Our U.S. provision for income taxes relates to current tax credits. On March 27, 2020, the U.S. government enacted the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) which provides for an accelerated refundexpense associated with taxable income that could not be offset by state net operating losses. We will utilize net operating losses to offset all of the remaining alternative minimum tax credit (“AMT credit”) carryforward which was held as a deferred tax asset of $0.1 million as of December 31, 2019. The CARES Act modificationsprojected 2021 federal taxable income; but have exhausted net operating losses and are subject to limitations in the limitation on business interest expense and net operating loss provisions are not expectedutilization in certain states. We have also recorded a foreign provision for income taxes related to have a material impact on our wholly owned subsidiary in Switzerland.
We account for uncertainty in income taxes recognized in the consolidated financial statement.

statements by applying
a two-step process

to determine the amount of tax benefit to be recognized. First, the tax position must be evaluated to determine the likelihood that it will be sustained upon external examination by the taxing authorities. If the tax position is

deemed more-likely-than-not to

be sustained, the tax position is then assessed to determine the amount of benefit to recognize in the consolidated financial statements. The amount of the benefit that may be recognized is the largest amount that has a greater than 50% likelihood of being realized upon ultimate settlement. The provision for income taxes includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered appropriate as well as the related net interest and penalties.
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Results of Operations

The following table sets forth, for the periods indicated, our results of operations:

   Three Months Ended
September 30,
   Nine Months Ended
September 30,
 
   2020   2019   2020   2019 

Net revenue

  $100,799   $64,265   $231,491   $186,336 

Cost of goods sold

   22,964    19,131    61,799    55,557 
  

 

 

   

 

 

   

 

 

   

 

 

 

Gross profit

   77,835    45,134    169,692    130,779 

Operating expenses:

        

Selling, general and administrative

   51,146    49,475    150,261    147,325 

Research and development

   3,709    3,924    13,787    11,159 
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

   54,855    53,399    164,048    158,484 
  

 

 

   

 

 

   

 

 

   

 

 

 

Income (loss) from operations

   22,980    (8,265   5,644    (27,705
  

 

 

   

 

 

   

 

 

   

 

 

 

Other expense, net:

        

Interest expense, net

   (2,969   (2,427   (8,391   (6,392

Loss on the extinguishment of debt

   —      —      —      (1,862

Gain on settlement of deferred acquisition consideration

   951    —      2,246    —   

Other income (expense), net

   44    (1   90    11 
  

 

 

   

 

 

   

 

 

   

 

 

 

Total other expense, net

   (1,974   (2,428   (6,055   (8,243
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss) before income taxes

   21,006    (10,693   (411   (35,948

Income tax expense

   (72   (48   (134   (108
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss)

  $20,934   $(10,741  $(545  $(36,056
  

 

 

   

 

 

   

 

 

   

 

 

 

   
Three Months Ended

June 30,
   
Six Months Ended

June 30,
 
   
2021
   
2020
   
2021
   
2020
 
Net revenue
  $123,196   $68,960   $225,748   $130,692 
Cost of goods sold
   29,940    20,042    55,435    38,835 
  
 
 
   
 
 
   
 
 
   
 
 
 
Gross profit
   93,256    48,918    170,313    91,857 
Operating expenses:
        
Selling, general and administrative
   62,349    46,502    120,581    99,115 
Research and development
   7,320    4,668    13,529    10,078 
  
 
 
   
 
 
   
 
 
   
 
 
 
Total operating expenses
   69,669    51,170    134,110    109,193 
  
 
 
   
 
 
   
 
 
   
 
 
 
Income (loss) from operations
   23,587    (2,252   36,203    (17,336
  
 
 
   
 
 
   
 
 
   
 
 
 
Other expense, net:
        
Interest expense, net
   (2,431   (2,912   (4,901   (5,422
Gain on settlement of deferred acquisition consideration
   —      —      —      1,295 
Other income, net
   18    25    15    46 
  
 
 
   
 
 
   
 
 
   
 
 
 
Total other expense, net
   (2,413   (2,887   (4,886   (4,081
  
 
 
   
 
 
   
 
 
   
 
 
 
Net income (loss) before income taxes
   21,174    (5,139   31,317    (21,417
Income tax expense
   (487   (27   (687   (62
  
 
 
   
 
 
   
 
 
   
 
 
 
Net income (loss)
  $20,687   $(5,166  $30,630   $(21,479
  
 
 
   
 
 
   
 
 
   
 
 
 
EBITDA and Adjusted EBITDA

Our management uses financial measures that are not in accordance with generally accepted accounting principles in the United States, or GAAP, in addition to financial measures in accordance with GAAP to evaluate our operating results.
These non-GAAP financial
measures should be considered supplemental to, and not a substitute for, our reported financial results prepared in accordance with GAAP. Our management uses Adjusted EBITDA to evaluate our operating performance and trends and make planning decisions. Our management believes Adjusted EBITDA helps identify underlying trends in our business that could otherwise be masked by the effect of the items that we exclude. Accordingly, we believe that Adjusted EBITDA provides useful information to investors and others in understanding and evaluating our operating results, enhancing the overall understanding of our past performance and future prospects, and allowing for greater transparency with respect to key financial metrics used by our management in its financial and operational decision-making.

29

Table of Contents
The following is a reconciliation of GAAP net income (loss) to
non-GAAP
EBITDA and
non-GAAP
Adjusted EBITDA for each of the periods presented:

   Three Months Ended
September 30,
   Nine Months Ended
September 30,
 
   2020   2019   2020   2019 
   (in thousands)   (in thousands) 

Net income (loss)

  $20,934   $(10,741  $(545  $(36,056

Interest expense, net

   2,969    2,427    8,391    6,392 

Income tax expense

   72    48    134    108 

Depreciation

   956    792    2,749    2,553 

Amortization

   885    1,529    2,518    4,526 
  

 

 

   

 

 

   

 

 

   

 

 

 

EBITDA

   25,816    (5,945   13,247    (22,477
  

 

 

   

 

 

   

 

 

   

 

 

 

Stock-based compensation expense

   486    242    1,164    700 

Gain on settlement of deferred acquisition consideration (1)

   (951   —      (2,246   —   

Loss on extinguishment of debt (2)

   —      —      —      1,862 

Exchange offer transaction costs (3)

   —      916    —      916 

Recovery of certain notes receivable from related parties (4)

   (1,111   —      (1,111   —   

Other costs and expenses (5)

   361    —      929    —   
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted EBITDA

  $24,601   $(4,787  $11,983   $(18,999
  

 

 

   

 

 

   

 

 

   

 

 

 

   
Three Months Ended

June 30,
   
Six Months Ended

June 30,
 
   
2021
   
2020
   
2021
   
2020
 
   
(in thousands)
   
(in thousands)
 
Net income (loss)
  $20,687   $(5,166  $30,630   $(21,479
Interest expense, net
   2,431    2,912    4,901    5,422 
Income tax expense
   487    27    687    62 
Depreciation
   1,063    891    2,073    1,793 
Amortization
   1,243    816    2,486    1,633 
  
 
 
   
 
 
   
 
 
   
 
 
 
EBITDA
   25,911    (520   40,777    (12,569
  
 
 
   
 
 
   
 
 
   
 
 
 
Stock-based compensation expense
   1,042    469    1,740    678 
Gain on settlement of deferred acquisition consideration (1)
   —      —      —      (1,295
Recovery of certain notes receivable from related parties (2)
   —      —      (179   —   
Change in fair value of Earnout (3)
   (2,762   —      (3,058   —   
Restructuring charge (4)
   939    —      1,866    —   
Transaction cost (5)
   —      325    —      568 
Cancellation fee (6)
   —      —      —      1,950 
  
 
 
   
 
 
   
 
 
   
 
 
 
Adjusted EBITDA
  $25,130   $274   $41,146   $(10,668
  
 
 
   
 
 
   
 
 
   
 
 
 
(1)

The amounts reflect

Amount reflects the gain recognized related to the settlement of the deferred acquisition consideration dispute with the sellers of NuTech Medical in February 2020 as well as the settlement of the assumed legacy lawsuit from the sellers of NuTech Medical in October 2020. See Note “15.“18. Commitments and Contingencies”.

(2)

The amount reflects the loss recognized on the extinguishment of the Master Lease Agreement upon repayment.

(3)

The amount reflects legal, advisory and other professional fees incurred in the quarter ended September 30, 2019 related directly to the warrant exchange transactions in Note “12. Stockholders’ Equity”.

(4)

The amount

Amount reflects the collection of certain notes receivable from related parties previously reserved. See Note “16.“19. Related Party Transactions”.

(3)
Amounts reflect the change in the fair value of the Earnout liability in connection with the CPN acquisition. See Note “3. Acquisition”.
(4)
Amounts reflect employee retention and benefits as well as the facility-related cost associated with the Company’s restructuring activities. See Note “12. Restructuring”.
(5)

The amounts

Amounts reflect the legal, advisory and other professional fees incurred in the three and nine months ended September 30, 2020 related directly to the CPN acquisition.

See Note “3. Acquisition”.

(6)
Amount reflects the cancellation fee for terminating certain product development and consulting agreements the Company inherited from NuTech Medical. See Note “18. Commitments and Contingencies”.
Comparison of the Three and NineSix Months Ended SeptemberJune 30, 20202021 and 2019

2020

Revenue

   

Three Months Ended

September 30,

   Change 
   2020   2019   $   % 
   (in thousands, except for percentages) 

Advanced Wound Care

  $89,990   $54,310   $35,680            66

Surgical & Sports Medicine

   10,809    9,955    854    9
  

 

 

   

 

 

   

 

 

   

 

 

 

Net revenue

  $100,799   $64,265   $36,534    57
  

 

 

   

 

 

   

 

 

   

 

 

 

   

Nine Months Ended

September 30,

   Change 
   2020   2019   $   % 
   (in thousands, except for percentages) 

Advanced Wound Care

  $201,009   $157,365   $43,644            28

Surgical & Sports Medicine

   30,482    28,971    1,511    5
  

 

 

   

 

 

   

 

 

   

 

 

 

Net revenue

  $231,491   $186,336   $45,155    24
  

 

 

   

 

 

   

 

 

   

 

 

 

   
Three Months Ended

June 30,
   
Change
 
   
2021
   
2020
   
$
   
%
 
   
(in thousands, except for percentages)
 
Advanced Wound Care
  $111,436   $59,731   $51,705    87
Surgical & Sports Medicine
   11,760    9,229    2,531    27
  
 
 
   
 
 
   
 
 
   
 
 
 
Net revenue
  $123,196   $68,960   $54,236    79
  
 
 
   
 
 
   
 
 
   
 
 
 
   
Six Months Ended

June 30,
   
Change
 
   
2021
   
2020
   
$
   
%
 
   
(in thousands, except for percentages)
 
Advanced Wound Care
  $202,144   $111,019   $91,125    82
Surgical & Sports Medicine
   23,604    19,673    3,931    20
  
 
 
   
 
 
   
 
 
   
 
 
 
Net revenue
  $225,748   $130,692   $95,056    73
  
 
 
   
 
 
   
 
 
   
 
 
 
30

Table of Contents
Net revenue from our Advanced Wound Care products increased by $35.7$51.7 million, or 66%87%, to $90.0$111.4 million in the three months ended SeptemberJune 30, 20202021 from $54.3$59.7 million in the three months ended SeptemberJune 30, 2019.2020. Net revenue from our Advanced Wound Care products increased by $43.6$91.1 million, or 28%82%, to $201.0$202.1 million in the ninesix months ended SeptemberJune 30, 20202021 from $157.4$111.0 million in the ninesix months ended SeptemberJune 30, 2019.2020. The increase in Advanced Wound Care net revenue was primarily attributable to the expanded sales force, increased sales to existing and new customers and increased adoption of our amniotic product portfolio, including our Affinity product.

Net revenue from our Surgical & Sports Medicine products increased by $0.9$2.5 million, or 9%27%, to $10.8$11.8 million in the three months ended SeptemberJune 30, 20202021 from $10.0$9.2 million in the three months ended SeptemberJune 30, 2019.2020. Net revenue from our Surgical & Sports Medicine products increased by $1.5$3.9 million, or 5%20%, to $30.5$23.6 million in the ninesix months ended SeptemberJune 30, 20202021 from $29.0$19.7 million in the ninesix months ended SeptemberJune 30, 2019.2020. The increase in Surgical & Sports Medicine net revenue was primarily attributable to the expanded sales force and penetration of existing and new customer accounts, partially offset by postponement or cancellation of medical procedures as a result of COVID-19.

accounts.

Included within net revenue is PuraPly revenue of $40.9$37.6 million and $31.8$28.5 million for the three months ended SeptemberJune 30, 20202021 and 2019,2020, respectively, and $102.0$78.9 million and $86.9$61.0 million for the ninesix months ended SeptemberJune 30, 20202021 and 2019,2020, respectively. PuraPly hadexited pass-through status in both of the periods.on October 1, 2020. The continued increase in PuraPly revenue in the three and nine month periodssix months ended June 30, 2021 was due to the expanded sales forces, and increased sales to existing and new customers.

customers, and increased adoption of our recently launched line extensions.

Cost of goods sold, gross profit and gross profit margin

   

Three Months Ended

September 30,

  Change 
   2020  2019  $   % 
   (in thousands, except for percentages) 

Cost of goods sold

  $22,964  $19,131  $3,833            20
  

 

 

  

 

 

  

 

 

   

 

 

 

Gross profit

  $  77,835  $  45,134  $32,701    72
  

 

 

  

 

 

  

 

 

   

 

 

 

Gross profit%

   77  70   

   

Nine Months Ended

September 30,

  Change 
   2020  2019  $   % 
   (in thousands, except for percentages) 

Cost of goods sold

  $61,799  $55,557  $6,242            11
  

 

 

  

 

 

  

 

 

   

 

 

 

Gross profit

  $169,692  $130,779  $38,913    30
  

 

 

  

 

 

  

 

 

   

 

 

 

Gross profit%

   73  70   

   
Three Months Ended

June 30,
  
Change
 
   
        2021        
  
        2020        
  
$
   
%
 
   
(in thousands, except for percentages)
 
Cost of goods sold
  $29,940  $20,042  $9,898    49
  
 
 
  
 
 
  
 
 
   
 
 
 
Gross profit
  $93,256  $48,918  $44,338    91
  
 
 
  
 
 
  
 
 
   
 
 
 
Gross profit%
   76  71   
   
Six Months Ended

June 30,
  
Change
 
   
2021
  
2020
  
$
   
%
 
   
(in thousands, except for percentages)
 
Cost of goods sold
  $55,435  $38,835  $16,600    43
  
 
 
  
 
 
  
 
 
   
 
 
 
Gross profit
  $170,313  $91,857  $78,456    85
  
 
 
  
 
 
  
 
 
   
 
 
 
Gross profit%
   75  70   
Cost of goods sold increased by $3.8$9.9 million, or 20%49%, to $23.0$29.9 million in the three months ended SeptemberJune 30, 20202021 from $19.1$20.0 million in the three months ended SeptemberJune 30, 2019.2020. Cost of goods sold increased by $6.2$16.6 million or 11%43% to $61.8$55.4 million in the ninesix months ended SeptemberJune 30, 20202021 from $55.6$38.8 million in the ninesix months ended SeptemberJune 30, 2019.2020. The increase in cost of goods sold was primarily due to increased unit volumes, and additional manufacturing and quality control headcount.

Gross profit increased by $32.7$44.3 million, or 72%91%, to $77.8$93.3 million in the three months ended SeptemberJune 30, 20202021 from $45.1$48.9 million in the three months ended SeptemberJune 30, 2019.2020. Gross profit increased by $38.9$78.5 million, or 30%85%, to $169.7$170.3 million in the ninesix months ended SeptemberJune 30, 20202021 from $130.8$91.9 million in the ninesix months ended SeptemberJune 30, 2019.2020. The increase in gross profit resulted primarily from increased sales volume due to the strength in our Advanced Wound Care and Surgical & Sports Medicine products as well as a shift in product mix to our higher gross margin products.

Research and Development Expenses

   

Three Months Ended

September 30,

  Change 
   2020  2019  $   % 
   (in thousands, except for percentages) 

Research and development

  $  3,709  $  3,924  $(215   (5%
  

 

 

  

 

 

  

 

 

   

 

 

 

Research and development as a percentage of net revenue

   4  6                            

   

Nine Months Ended

September 30,

  Change 
   2020  2019  $   % 
   (in thousands, except for percentages) 

Research and development

  $13,787  $11,159  $2,628            24
  

 

 

  

 

 

  

 

 

   

 

 

 

Research and development as a percentage of net revenue

   6  6   

   
Three
Months Ended

June 30,
  
Change
 
   
2021
  
2020
  
$
   
%
 
   
(in thousands, except for percentages)
 
Research and development
  $7,320  $4,668  $2,652    57
  
 
 
  
 
 
  
 
 
   
 
 
 
Research and development as a percentage of net revenue
   6  7   
31

Table of Contents
   
Six Months Ended

June 30,
  
Change
 
   
2021
  
2020
  
$
   
%
 
   
(in thousands, except for percentages)
 
Research and development
  $13,529  $10,078  $3,451    34
  
 
 
  
 
 
  
 
 
   
 
 
 
Research and development as a percentage of net revenue
   6  8   
Research and development expenses decreasedincreased by $0.2$2.7 million, or (5%)57%, to $3.7$7.3 million in the three months ended SeptemberJune 30, 20202021 from $3.9$4.7 million in the three months ended SeptemberJune 30, 2019. The decrease was primarily due to delayed enrollment in trials and limited clinical spending due to the COVID-19.2020. Research and development expenses increased by $2.6$3.5 million, or 24%34%, to $13.8$13.5 million in the ninesix months ended SeptemberJune 30, 20202021 from $11.2$10.1 million in the ninesix months ended SeptemberJune 30, 2019.2020. The increase in research and development expenses was primarily due to an increase in process development costs associated with a new contract manufacturer, increased headcount associated with our existing Advanced Wound Care and Surgical & Sports Medicine products, an increase in product costs associated with our pipeline products not yet commercialized and an increase in the clinical study and related costs necessary to move products through theseek regulatory pathway (e.g., seek BLA approval). The increase was partially offset by a decrease due to delayed enrollment in trials and limited clinical spending due to the COVID-19.

approvals for certain of our products.

Selling, General and Administrative Expenses

   

Three Months Ended

September 30,

  Change 
   2020  2019  $   % 
   (in thousands, except for percentages) 

Selling, general and administrative

  $  51,146  $  49,475  $1,671            3
  

 

 

  

 

 

  

 

 

   

 

 

 

Selling, general and administrative as a percentage of net revenue

   51  77   

   

Nine Months Ended

September 30,

  Change 
   2020  2019  $   % 
   (in thousands, except for percentages) 

Selling, general and administrative

  $150,261  $147,325  $2,936            2
  

 

 

  

 

 

  

 

 

   

 

 

 

Selling, general and administrative as a percentage of net revenue

   65  79   

   
Three Months Ended

June 30,
  
Change
 
   
2021
  
2020
  
$
   
%
 
   
(in thousands, except for percentages)
 
Selling, general and administrative
  $62,349  $46,502  $15,847    34
  
 
 
  
 
 
  
 
 
   
 
 
 
Selling, general and administrative as a percentage of net revenue
   51  67   
   
Six Months Ended

June 30,
  
Change
 
   
2021
  
2020
  
$
   
%
 
   
(in thousands, except for percentages)
 
Selling, general and administrative
  $120,581  $99,115  $21,466    22
  
 
 
  
 
 
  
 
 
   
 
 
 
Selling, general and administrative as a percentage of net revenue
   53  76   
Selling, general and administrative expenses increased by $1.7$15.8 million, or 3%34%, to $51.1$62.3 million in the three months ended SeptemberJune 30, 20202021 from $49.5$46.5 million in the three months ended SeptemberJune 30, 2019.2020. The increase in selling, general and administrative expenses was primarily due to a $6.4$10.2 million increase related to additional headcount, primarily in our direct sales force and increased sales commissions due to increased sales, a $0.4$4.2 million increase in credit card processing fees duerelated to increased collection and $0.2 million increase in royalties due to increased sales. These increases were partially offset by a $3.3 million decrease related to reduced travel and marketing programs amid the relaxed travel restrictions for the
COVID-19,
a $0.9 million increase in place due to the COVID-19, a $0.6 million decrease in amortizationrestructuring cost associated with intangible assets amortized using an accelerated method,closing La Jolla office, and a $0.6$3.3 million decreaseincrease in various costs resulting from increased revenue and increase in legal, consulting fees and other costs associated with the ongoing operations of our business andbusiness. These increases were partially offset by a $0.8$2.8 million decrease in bad debt primarily due toresulting from the collection of the previously reserved related party receivables.

CPN Earnout fair value adjustment.

Selling, general and administrative expenses increased by $2.9$21.5 million, or 2%22%, to $150.3$120.6 million in the ninesix months ended SeptemberJune 30, 20202021 from $147.3$99.1 million in the ninesix months ended SeptemberJune 30, 2019.2020. The increase in selling, general and administrative expenses was primarily due to a $10.5$19.7 million increase related to additional headcount, primarily in our direct sales force and increased sales commissions due to increased sales, a $2.0 million cancellation fee for certain product development and consulting agreements, and a $0.9$1.9 million increase in credit card processing fees due torestructuring cost associated with closing La Jolla office, and a $5.1 million increase in various costs resulting from increased collection. These increases were partially offset by a $6.4 million decrease related to reduced travelrevenue and marketing programs amid travel restrictions in place due to the COVID-19, a $1.4 million decreaseincrease in legal, consulting fees and other costs associated with the ongoing operations of our business,business. These increases were partially offset by a $2.0$3.1 million decrease in amortization associated withresulting from the intangible assets amortized using an accelerated methodCPN Earnout fair value adjustment and a $0.8$2.0 million decrease in bad debt primarily duethe cancellation fee incurred in the three months ended March 31, 2020 to the collectioncancel certain product development and consulting agreements.
32

Table of the previously reserved related party receivables.

Contents

Other Expense, net

   

Three Months Ended

September 30,

   Change 
   2020   2019   $   % 
   (in thousands, except for percentages) 

Interest expense, net

  $(2,969  $(2,427  $(542   22

Gain on settlement of deferred acquisition consideration

   951    —      951      100

Other income (expense), net

   44    (1   45    *
  

 

 

   

 

 

   

 

 

   

 

 

 

Total other expense, net

  $(1,974  $(2,428  $    454    (19%) 
  

 

 

   

 

 

   

 

 

   

 

 

 

   

Nine Months Ended

September 30,

   Change 
   2020   2019   $   % 
   (in thousands, except for percentages) 

Interest expense, net

  $(8,391  $(6,392  $(1,999   31

Loss on the extinguishment of debt

   —      (1,862   1,862    (100%) 

Gain on settlement of deferred acquisition consideration

   2,246    —      2,246    100

Other income, net

   90    11    79    *
  

 

 

   

 

 

   

 

 

   

 

 

 

Total other expense, net

  $(6,055  $(8,243  $2,188    (27%) 
  

 

 

   

 

 

   

 

 

   

 

 

 

**

not meaningful

Other

   
Three Months Ended

June 30,
   
Change
 
   
2021
   
2020
   
$
   
%
 
   
(in thousands, except for percentages)
 
Interest expense, net
  $(2,431  $(2,912  $481    (17%) 
Other income (expense), net
   18    25    (7   (28%) 
  
 
 
   
 
 
   
 
 
   
 
 
 
Total other expense, net
  $(2,413  $(2,887  $474    (16%) 
  
 
 
   
 
 
   
 
 
   
 
 
 
   
Six Months Ended

June 30,
   
Change
 
   
2021
   
2020
   
$
   
%
 
   
(in thousands, except for percentages)
 
Interest expense, net
  $(4,901  $(5,422  $521    (10%) 
Gain on settlement of deferred acquisition consideration
   —      1,295    (1,295   (100%) 
Other income, net
   15    46    (31   (67%) 
  
 
 
   
 
 
   
 
 
   
 
 
 
Total other expense, net
  $(4,886  $(4,081  $(805   20
  
 
 
   
 
 
   
 
 
   
 
 
 
Total other expense, net, decreased by $0.5 million, or 19%16%, to $2.0 million in the three months ended September 30, 2020 from $2.4 million in the three months ended SeptemberJune 30, 2019.2021 from $2.9 million in the three months ended June 30, 2020. The decrease is primarily due to a $1.0 million decrease in legal accruals related to the settlement of the assumed legacy lawsuit from the sellers of NuTech Medical in October 2020. We assumed the legacy lawsuit as part of the resolution of the deferred acquisition consideration dispute with the sellers of NuTech Medical in February 2020. The decrease was partially offset by a $0.5 million or 22% increase in interest expense resulting from the increasedreduced borrowings under the 2019 Credit Agreement.

Other

Total other expense, net, increased by $0.8 million or 20% to $4.9 million in the six months ended June 30, 2021 from $4.1 million in the six months ended June 30, 2020. Interest expense, net, decreased by $2.2$0.5 million or 27% to $6.1 million in the nine months ended September 30, 2020 from $8.2 million in the nine months ended September 30, 2019. Interest expense, net, increased by $2.0 million or 31%10% primarily due to the increasedreduced borrowings under the 2019 Credit Agreement. The lossgain of $1.3 million on the extinguishmentsettlement of debt of $1.9 milliondeferred acquisition consideration for the ninesix months ended September 30, 2019 reflected the write-off of unamortized debt discount upon repayment of the Master Lease Agreement as well as early payment penalties in March 2019. The gain of $2.2 million for the nine months ended SeptemberJune 30, 2020 was related to the settlement of the deferred acquisition consideration dispute with the sellers of NuTech Medical in February 2020 as well as the decrease in legal accruals related to the settlement of a legacy lawsuit in October 2020. We assumed the legacy lawsuit from the sellers of NuTech Medical as part of the resolution of the aforementioned dispute.

Liquidity and Capital Resources

Since our inception, we have funded our operations and capital expenditures through cash flows from product sales, loans from affiliates and entities controlled by certain of our affiliates, third-party debt and proceeds from the sale of our capital stock. As of SeptemberJune 30, 2020,2021, we had $36.5 million in cash and $62.8$117.2 million in working capital.capital which included $89.8 million in cash. We also had up to $30,000 available (subject to Borrowing Base) for future revolving borrowings under our Revolving Facility (see Note “13. Long-Term Debt Obligations”). We expect that our cash on hand and other components of working capital as of SeptemberJune 30, 2020,2021, availability under the 2019 Credit Agreement, plus net cash flows from product sales, will be sufficient to fund our operating expenses, capital expenditure requirements and debt service payments for at least 12 months beyond the filing date of this quarterly report. We continue to closely monitor ongoing developments in connection with the
COVID-19
pandemic, which may negatively impact our commercial prospects, cash position and access to capital in fiscal 20202021 or beyond. We will continue to assess our cash and other sources of liquidity and, if circumstances warrant, we will make appropriate adjustments to our operating plan. Please see “Item 1A. Risk Factors” in this Quarterly Report on Form 10-Q for an additional discussion of risks and potential risks of the COVID-19 pandemic on our business, financial condition and results of operations.

Our primary uses of cash are working capital requirements, capital expendituresexpenditure and debt service payments. Additionally, from time to time, we may use capital for acquisitions and other investing and financing activities. Working capital is used principally for our personnel as well as manufacturing costs related to the production of our products. Our working capital requirements vary from period-to-periodperiod to period depending on manufacturing volumes, the timing of shipments and the payment cycles of our customers and payers. Our capital expenditures consist primarily of building improvements, manufacturing equipment, and computer hardware and software.

To the extent additional funds are necessary to meet our long-term liquidity needs as we continue to execute on our business strategy, we anticipate that they will be obtained through additional equity or debt financings, other strategic transactions or a combination of these potential sources of funds. There can be no assurance that we will be able to obtain additional funds on terms acceptable to us, on a timely basis or at all, particularly in light of the adverse impacts of the COVID-19 pandemic on the capital markets.all. Any failure to obtain sufficient funds on acceptable terms when needed could have a material adverse effect on our business, results of operations, and financial condition. Our current borrowings under the 2019 Credit Agreement are subject to compliance with certain financial covenants regarding Minimum Trailing Twelve Month Consolidated Revenue and Non-PuraPly revenue. If we are not able to comply with these covenants, due to the impacts
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Table of COVID-19 or otherwise, the borrowings under the 2019 Credit Agreement may become due and payable immediately unless we obtain an amendment from our lenders. There can be no assurance that our lenders would agree to any such amendment on acceptable terms, or at all.

Contents

Cash Flows

The following table summarizes our cash flows for each of the periods presented:

   Nine Months Ended
September 30,
 
   2020   2019 
   (in thousands) 

Net cash used in operating activities

  $(19,475  $(27,127

Net cash used in investing activities

   (16,354   (2,776

Net cash provided by financing activities

   12,345    31,657 
  

 

 

   

 

 

 

Net change in cash and restricted cash

  $(23,484  $1,754 
  

 

 

   

 

 

 

   
Six Months Ended

June 30,
 
   
2021
   
2020
 
   
(in thousands)
 
Net cash provided by (used in) operating activities
  $16,180   $(26,618
Net cash used in investing activities
   (9,290   (6,118
Net cash used in (provided by) financing activities
   (1,389   13,120 
  
 
 
   
 
 
 
Net change in cash and restricted cash
  $5,501   $(19,616
  
 
 
   
 
 
 
Operating Activities

During the ninesix months ended SeptemberJune 30, 2020,2021, net cash used inprovided by operating activities was $19.5$16.2 million, resulting from our net lossincome of $0.5$30.6 million and
non-cash
charges of $14.1 million, partially offset by net cash used in connection with changes in our operating assets and liabilities of $28.6$28.5 million. $28.5 million partially offset by non-cash charges of $9.6 million. Net cash used in changes in our operating assets and liabilities included an increase in accounts receivable of $19.2$22.1 million, an increase in inventory of $7.8$5.0 million, an increase in prepaid expenses and other current assets of $2.3$1.6 million, and a decrease in accounts payableoperating leases and other liabilities of $3.8$3.1 million, all of which were partially offset by an increase in accounts payable, accrued expenses and other liabilities of $4.4$3.4 million.

During the ninesix months ended SeptemberJune 30, 2019,2020, net cash used in operating activities was $27.1$26.6 million, resulting from our net loss of $36.1$21.5 million and net cash used in connection with changes in our operating assets and liabilities of $3.3$12.0 million, partially offset
by non-cash charges
of $12.2$6.9 million. Net cash used in changes in our operating assets and liabilities includesincluded an increase in inventory of $7.8$7.4 million, an increase in prepaid expenses and other current assets of $0.7$1.3 million, and a decreasean increase in other liabilitiesaccounts receivable of $0.7$5.7 million, all of which were partially offset by a decrease in accounts receivable of $0.6 million and an increase in accounts payable, and accrued expenses and other current liabilities of $5.4$2.4 million.

Investing Activities

During the ninesix months ended SeptemberJune 30, 2021, we used $9.3 million of cash in investing activities solely consisting of capital expenditures.
During the six months ended June 30, 2020, we used $16.4$6.1 million of cash in investing activities consisting of capital expenditures of $12.3$6.4 million, payment of $5.8 million related to the acquisition of CPN partially offset by notes receivable repayment of $1.7$0.3 million from one of our former executives.

Financing Activities
During the ninesix months ended SeptemberJune 30, 2019, we2021, net cash used $2.8in financing activities was $1.4 million. This consisted primarily of the payment of finance lease obligations of $1.4 million, the payment of $0.5 million related to the NuTech Medical deferred acquisition consideration, and the payments of $0.7 million withholding taxes in connection with stock-based awards. The net cash used by financing activities was partially offset by the $1.2 million in investing activities consistingproceeds from the exercise of capital expenditures and an intangible asset purchase.

Financing Activities

common stock options.

During the ninesix months ended SeptemberJune 30, 2020, net cash provided by financing activities was $12.3$13.1 million. This consisted primarily of $15.9 million in proceeds from our 2019 Credit Agreement, and $1.3$0.9 million in proceeds from the exercise of common stock options. The net cash provided by financing activities was partially offset by the payment of capitalfinance lease obligations of $1.8$1.1 million and the payment of $3.0$2.6 million related to the NuTech Medical deferred acquisition consideration.

During the nine months ended September 30, 2019, net cash provided by financing activities was $31.7 million. This consisted primarily of $56.1 million in net proceeds from the

Indebtedness
2019 Credit Agreement and $0.8 million in proceeds from the exercise of common stock warrants and options. The net cash provided by financing activities was partially offset by the payment of the put option on redeemable common stock of $6.8 million, repayment of the Master Lease Agreement of $17.6 million, and repayment of capital lease obligations of $0.9 million.

Indebtedness

2019 Credit Agreement

On March 14, 2019, we and our subsidiaries entered into a credit agreement with SVB and several other lenders, which we refer to as the 2019 Credit Agreement. Capitalized terms used herein and not otherwise defined are defined as set forth in the 2019 Credit Agreement.

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Table of Contents
The 2019 Credit Agreement, as amended, provides for a revolving credit facility (the “Revolving Facility”) of up to the lesser of $40.0 million and the amount determined by the Borrowing Base. Additionally, we entered into a $60.0 million term loan (the “Term Loan Facility”) structured in three tranches. The first tranche of $40.0 million was made available to us and fully funded on March 14, 2019; (ii) the second tranche of $10.0 million was made available to us and fully funded in September 2019 upon achievement of certain financial metrics; and (iii) the third tranche of $10.0 million was made available to us and fully funded in March 2020 upon achievement of a certain financial metric.

We are required to comply with certain covenants and restrictions under the 2019 Credit Agreement. If we fail to comply with these requirements, the lenders will be entitled to exercise certain remedies, including the termination of the lending commitments and the acceleration of the debt payments under either or both of the Revolving Facility and the Term Loan Facility. We are also required to achieve certain financial covenants, including Minimum Trailing Twelve Month Consolidated Revenue and
Non-PuraPly
Revenue, tested quarterly. The Minimum Trailing Twelve Month Consolidated Revenue thresholds for the year ending December 31, 2020 were agreed to and the covenant requiring Trailing Twelve Month Non-PuraPly Revenue beginning with the quarter ending September 30, 2020 was added in connection with the third amendment to the 2019 Credit Agreement entered into on March 26, 2020. The Minimum Trailing Twelve Month Consolidated Revenue requirements for the year ending December 31, 20202021 are set at the following levels: $235.0$265.6 million for the trailing twelve months ending March 31, 2020; $253.02021; $269.6 million for the trailing twelve months ending June 30, 2020; $260.02021; $306.1 million for the trailing twelve months ending September 30, 2020;2021; and $262.0$338.3 million for the trailing twelve months ending December 31, 2020.2021. The Trailing Twelve Month
Non-PuraPly
Revenue requirements are set at the following levels: $136.5$141.6 million for the trailing twelve months ending March 31, 2021; $147.2 million for the trailing twelve months ending June 30, 2021; $176.6 million for the trailing twelve months ending September 30, 2020;2021; and $145.0$205.4 million for the trailing twelve months ending December 31, 2020. The minimum revenue covenant levels for 2021 are to be agreed with the lenders no later than March 31, 2021. We are also required to maintain Minimum Liquidity equal to the greater of (i) 6 months Monthly Burn and (ii) $10.0 million.

As of SeptemberJune 30, 2020,2021, we were in compliance with the financial covenants under the 2019 Credit Agreement and we had outstanding borrowings under the Revolving Facility and Term Loan Facility of the 2019 Credit Agreement of $39.4$10.0 million and $60.0 million, respectively.

2017 Credit Agreement

In March 2017,

On August 6, 2021, we entered into a credit agreement with SVB, which we refer to as the 2017 Credit Agreement. The 2017 Credit Agreement, as amended, provided for a revolving credit facility of up to $30.0 million and a term loan of up to $5.0 million. The term loan was repaid in full in December 2018. Upon entering into the 2019 Credit Agreement, the outstanding amount due under the 2017 Credit Agreement was fully repaid and terminated.

Master Lease Agreement

In April 2017, we entered into the Master Lease Agreement (the “ML Agreement”) with Eastward Fund Management LLC. In March 2019, upon entering into the 2019 Credit Agreement, we paid an aggregate amount of $17.6 million due under the ML Agreement with proceeds fromterminated the 2019 Credit Agreement and the ML Agreement was terminated. Upon termination of the ML Agreement, we recognized $1.9 million as loss on the extinguishment of the loan.

entered into a new credit agreement. Please refer to Note “21. Subsequent Events” for more information.

Contractual Obligations and Commitments

There have been no material changes to our contractual obligations and commitments as of SeptemberJune 30, 20202021 from those disclosed in our Annual Report on Form
10-K
for the year ended December 31, 2019.

2020.

Critical Accounting Policies and Significant Judgments and Estimates

Our consolidated financial statements have been prepared in accordance with GAAP. The preparation of our consolidated financial statements requires us to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, and the disclosure at the date of the financial statements, as well as revenue and expenses recorded during the reporting periods. Management bases its estimates, assumptions and judgments on historical experience and on various other factors that it believes to be reasonable under the circumstances. Different assumptions and judgments would change the estimates used in the preparation of our consolidated financial statements, which, in turn, could materially change our results from those reported. Management evaluates its estimates, assumptions and judgments on an ongoing basis. Historically, our critical accounting estimates have not differed materially from actual results. However, if our assumptions change, especially given the risks and uncertainties related to COVID-19,we may need to revise our estimates, or take other corrective actions, either of which may also have a material adverse effect on our consolidated statements of operations, liquidity and financial condition. See also our Annual Report on Form
10-K
for the fiscal year ended December 31, 20192020 for information about these accounting policies as well as a description of our other significant accounting policies.

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Table of Contents
Emerging Growth Company Status

We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, and we may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies. We may take advantage of these exemptions until we are no longer an emerging growth company. Section 107 of the JOBS Act provides that an emerging growth company can take advantage of the extended transition period afforded by the JOBS Act for the implementation of new or revised accounting standards. We have elected to use the extended transition period for complying with new or revised accounting standards (such as
ASU 2016-02,
Leases
(Topic 842)
) and, as a result of this election, our financial statements may not be comparable to companies that comply with public company effective dates. We may take advantage of these exemptions up until the last day of the fiscal year following October 14,December 31, 2021, the fifth anniversary of our IPO, or such earlier time that we are no longer an emerging growth company. We would cease to be an emerging growth company if we have more than $1.07 billion in annual revenue, we have more than $700.0 million in market value of our stock held by
non-affiliates
or we issue more than $1.0 billion of
non-convertible
debt securities over a three-year period.

Off-Balance
Sheet Arrangements

We did not have, during the periods presented, and we do not currently have, any
off-balance
sheet arrangements, as defined in the rules and regulations of the SEC.

Recently Issued Accounting Pronouncements

We have reviewed all recently issued standards as disclosed in Note “2. Summary of Significant Accounting Policies” to our consolidated financial statements included in this Report on
Form 10-Q.

Item 3. Quantitative and Qualitative Disclosures about Market Risk.

Pursuant to Item 305(e) of Regulation
S-K, the
Company is not required to provide the information required by this Item as it is a “smaller reporting company,” as defined by Rule 229.10(f)(1).

Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

Material Weaknesses on Internal Control over Financial Reporting

The Company’s management, with the participation of its principal executive officer and principal financial officer, evaluated the effectiveness of its disclosure controls and procedures as of SeptemberJune 30, 2020.2021. The term “disclosure controls and procedures,” as defined in
Rules 13a-15(e) and15d-15(e) under
the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the rules and forms promulgated by the Securities and Exchange Commission (the “SEC”). Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

Because of inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions or that the degree of compliance with the policies or procedures may deteriorate.

Accordingly, even effective internal control over financial reporting can only provide reasonable assurance of achieving their control objectives.

Under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, our management has assessed the effectiveness of our internal control over financial reporting based on the criteria set forth in the Internal Control-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).

As previously disclosed under “Item 9A. Controls and Procedures” in our Annual Report on Form
10-K
for our fiscal year ended December 31, 2019,2020, we identified the following material weakness that existed as of December 31, 20192020 and continued to exist at SeptemberJune 30, 2020.2021. A material weakness is a control deficiency or a combination of control deficiencies that results in more than a remote likelihood that a material misstatement of the annual or interim financial statements will not be prevented or detected.

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Table of Contents
We did not design and maintain formal accounting, business operations, and Information Technology policies, procedures and controls to achieve complete, accurate and timely financial accounting, reporting and disclosures, including (i) formalized policies and procedures for reviews over account reconciliations, journal entries, and other accounting analyses and memos and procedures to ensure completeness and accuracy of information used in these review controls and (ii) controls to support the objectives of proper segregation of the initiation of transactions, the recording of transactions, and the custody of assets.

Because of the deficiencies noted above, in consultation with management, our principal executive officer and principal financial officer concluded that we did not maintain effective internal control over financial reporting and our disclosure controls and procedures were not effective as of both December 31, 20192020 and SeptemberJune 30, 2020,2021, based on the criteria in Internal Control—Integrated Framework (2013) issued by COSO.

Plans for Remediation of Material Weakness

Management is currently takinghas taken actions to remediate the deficiencies in its internal controls over financial reporting and is implementingimplemented additional processes and controls designed to address the underlying causes associated with the above-mentioned material weakness. Although the Company has made significant progress in remediating the aforementioned deficiencies, management did not perform sufficient control testing to conclude that the material weakness was remediated and therefore somecontrols were operating effectively for a reasonable period of the control deficiencies continued to exist as of September 30, 2020. time.
Management is committed to remediatingfinalizing the remediation of the material weakness described above and remediation efforts have continued in 2020.during 2021. Management’s internal control remediation efforts include the following:

We

In 2019, we began the implementation of a new company-wide enterprise resource planning system to provide additional systematic controls and segregation of duties for our accounting processes. We anticipate that the enterprise resource planning system will go live induring the first half of 2021.

2022.

We have designed and implemented more effective controls throughout 2019 which continued into 2020and 2020.
We completed the risk assessment activities by evaluating whether the design of our internal controls appropriately addresses changes in the business (including changes to people, processes and systems) that should remediate these deficiencies once they have been implementedcould impact our system of internal controls.
We designed controls that address the completeness and have had sufficient time for them to operate effectively.

accuracy of any key reports utilized in the execution of internal controls.

We formalized, and provided training on, certain policies, including a procurement and contract management policy.

We engaged an outside firm to assist management with:

a)

Enhancing the execution of our risk assessment activities by evaluating whether the design of our internal controls appropriately addresses changes in the business (including changes to people, processes and systems) that could impact our system of internal controls;

b)

Reviewing our current processes, procedures and systems to identify opportunities to enhance the design of each process and to include additional control activities that will ensure all transactions are properly recorded;

c)

Designing controls that address the completeness and accuracy of any key reports utilized in the execution of internal controls; and

d)

Developing a monitoring protocol that will allow the Company to validate the operating effectiveness of certain controls over financial reporting to gain assurance that such controls are present and functioning as designed.

We have reported regularly to the audit committee on the progress and results of control remediation.

We developed and executed upon a monitoring protocol that allows the remediation plan, including the identification, status and resolution of internal control deficiencies.

In addition to implementing and refining the above activities, we engaged in additional activities in 2020, including engaging the same outside firm to assist management with:

Monitoring the progress of the remediation plan established by management.

Performing testingCompany to validate the operating effectiveness of certain controls over financial reporting to gain assurance that such controls are present and functioning as designed.

We also continue to engage an outside firm to assist management with performing sufficient testing throughout the year to validate the operating effectiveness of certain controls over financial reporting.

Management believes these actions will be effective in remediating the material weakness described above. As management continues to evaluate and work to improve its internal control over financial reporting, management may determine it is necessary to take additional measures to address the material weakness or determine to modify the remediation plan described above.weakness. Until the remediation steps set forth above are fully implemented andcontrols have been operating for a sufficient period of time and management has concluded, through testing, that these controls are operating effectively, the material weakness described above will continue to exist.

Changes in Internal Control Over Financial Reporting

Other than in connection with executing upon the implementation of the remediation plan outlined above, there were

There have been no changes in our internal control over financial reporting that occurred during the periodquarter ended SeptemberJune 30, 20202021 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting other than those described above related to remediation efforts. However, as the implementation of the new ERP system continues, we will change our processes and procedures, which in turn, could result in changes to our internal control over financial reporting.

As such changes occur, we will evaluate quarterly whether such changes materially affect our internal control over financial reporting.

37

PART II – OTHER INFORMATION

Item 1. Legal Proceedings

We are not a party to any material legal proceedings. From time to time, we may become involved in litigation or other legal proceedings relating to claims arising from the ordinary course of business. These matters may include intellectual property, employment and other general claims. With respect to our outstanding legal matters, based on our current knowledge, we believe that the amount or range of reasonably possible loss will not, either individually or in the aggregate, have a material adverse effect on our business, consolidated financial position, results of operations, or cash flows. However, the outcome of such legal matters is inherently unpredictable and subject to significant uncertainties.

Item 1A. Risk Factors

Investing in our common stock involves a high degree of risk. Our Annual Report on Form
10-K
for the year ended December 31, 2019,2020, as amended, includes a detailed discussion of our risk factors under the heading “Part I, Item 1A—Risk Factors.” Except as set forth below, there have been no material changes from such risk factors during the quarter ended SeptemberJune 30, 2020.2021. You should consider carefully the risk factors discussed in our Annual Report on Form
10-K
for the year ended December 31, 2019,2020, and all other information contained in or incorporated by reference in this Quarterly Report on Form
10-Q
before making an investment decision. If any of the risks discussed in the Annual Report on Form
10-K
for the year ended December 31, 20192020 or herein actually occur, they may materially harm our business, financial condition, operating results, cash flows or growth prospects. As a result, the market price of our common stock could decline, and you could lose all or part of your investment. Additional risks and uncertainties that are not yet identified or that we think are immaterial may also materially harm our business, financial condition, operating results, cash flows or growth prospects and could result in a complete loss of your investment.

Significant disruptions of our information technology systems or breaches of information security could adversely affect our business, results of operations and financial condition.

We rely

On May 6, 2021, we ceased to a large extent upon sophisticated information technology systems to operate our business. In the ordinary course of business, we collect, store and transmit large amounts of confidential information (including, but not limited to, personal information and intellectual property). We also have outsourced significant elements of our operations to third parties, including significant elements of our information technology infrastructure and,qualify as a result,“controlled company” within the meaning of the Nasdaq rules. Although we are managing many independent vendor relationships with third parties whono longer a controlled company, during the
phase-in
period we may or could have access to our confidential information. The size and complexity of our information technology and information security systems, and those of our third-party vendors with whom we contract (and the large amounts of confidential information that is present on them), make such systems potentially vulnerable to service interruptions or to security breaches from inadvertent or intentional actions by our employees or vendors, or from malicious attacks by third parties. Such attacks are of ever-increasing levels of sophistication and are made by groups and individuals with a wide range of motives (including, but not limited to, industrial espionage and market manipulation) and expertise. While we have invested significantly in the protection of data and information technology, and will continue to do so, there can be no assurancerely on exemptions from certain corporate governance requirements that our efforts will prevent service interruptions or security breaches. For example, in August 2020, our information technology (“IT”) systems were exposedprovide protection to stockholders of other Nasdaq listed companies.
On May 6, 2021, upon the completion of a ransomware attack, which partially impaired certain IT systems for a short perioddistribution by Organo PFG LLC, an affiliate of time. We are investigating the incident, together with legal counsel and other incident response professionals. We do not believe that we have experienced any material losses related to the ransomware attack and were able to recover all data quickly, with only a minimal and temporary interruption to our business. While we have implemented measures to protect our data security and information technology systems, such measures may not prevent these events. Although we have cyber-insurance coverage that may cover certain events described above, this insurance is subject to deductibles and coverage limitations and we may not be able to maintain this insurance. Also, it is possible that claims could exceed the limits of our coverage. Any interruption or breach in our systems could adversely affect our business operations and/or result in the loss of critical or sensitive confidential information or intellectual property, and could result in financial, legal, business and reputational harm to us or allow third parties to gain material, inside information that they use to trade in our securities.

Interruptions in the supply of our products or inventory loss may adversely affect our business, results of operations and financial condition.

Our products are manufactured using technically complex processes requiring specialized facilities, highly specific raw materials and other production constraints. The complexity of these processes, as well as strict company and government standards for the manufacture and storage of our products, subjects us to production risks. In addition to ongoing production risks, process deviations or unanticipated effects of approved process changes may result in non-compliance with regulatory requirements including stability requirements or specifications. Most of our products must be stored and transported within a specified temperature range. For example, if environmental conditions deviate from that range, our products’ remaining shelf-lives could be impaired or their safety and efficacy could be adversely affected, making them unsuitable for use. These deviations may go undetected. The occurrence of actual or suspected production and distribution problems can lead to lost inventories, and in some cases recalls, with consequential reputational damage and the risk of product liability. The investigation and remediation of any identified problems can cause production delays and result in substantial additional expenses. Production of our Affinity product, for example, was suspended in the first quarter of 2019 due to production issues at one of our suppliers. Although our supplier has implemented certain corrective measures, we have determined that the current process does not meet our production standards. Asdirectors and a result, we identified an alternate supplier, and were only able to resume commercial-scale production in the second quartersignificant stockholder, of 2020. This disruption in supply resulted in reduced Affinity revenue. Although we were able to partially offset the lost Affinity revenue by increasing production of our other products, there can be no assurance that we will be able to do so in the event of any future suspensions or failures in the storage or manufacturing of Affinity, Dermagraft (including in connection with the expected suspension of manufacturing of Dermagraft in the fourth quarter of 2021) or our other products. Any future failure in the storage or manufacture of our products or loss in supply could result in a loss of our market share and negatively affect our revenues and operations.

We are dependent on the proper functioning of our and third-party manufacturing facilities, our supply chain and our sales force, all of which could be negatively impacted by the global COVID-19 pandemic in a manner that could materially adversely affect our business, financial condition or results of operations.

Our ability to manufacture products may be materially adversely impacted by the coronavirus.

COVID-19 is continuing to impact worldwide economic activity. Estimates for economic growth have been reduced and may have a corresponding effect on our sales activity. The virus has been declared a pandemic by the World Health Organization and has spread globally to over 180 countries, including the United States. The impact of this pandemic has been and will likely continue to be extensive in many aspects of society, which has resulted in and will likely continue to result in significant disruptions to the global economy, as well as businesses and capital markets around the world. We, like many employers in the United States, have required (with limited exceptions) employees to work from home or not come into their offices or facilities. We manufacture our non-amniotic products and use third-party manufacturers for our amniotic products and we use third-party raw material suppliers to support our internal manufacturing processes. Our manufacturing facilities have, thus far, remained operational as “essential” services under applicable regulatory orders. If our manufacturing capabilities or the manufacturing capabilities of our suppliers are impacted as a result of COVID-19, it may not be possible for us to timely manufacture relevant products at the required levels or at all. A reduction or interruption in any of our manufacturing processes could have a material adverse effect on our business, results of operations, financial condition and cash flows. Further, remote work may disrupt our operations or increase the risk of a cybersecurity incident.

We also may be unable to obtain the raw materials necessary to support our internal manufacturing processes due to the additional constraints on suppliers created by COVID-19. Any delays in the delivery of these raw materials and delay manufacturing of our products may result in the cancellation of orders for our products.

In addition, the manufacture of our products is dependent on the availability of sufficient quantities of source tissue, which is the primary component of our products. Source tissue includes donated human tissue, porcine tissue and bovine tissue. We acquire donated human tissue directly through institutional review board approved protocols at multiple hospitals, as well as through tissue procurement firms engaged by us or by our contract manufacturers. Any failure to obtain tissue from our sources, including any failures related to COVID-19, will interfere with our ability to effectively meet demand for our products. Any interruption in the supply of source tissue could materially harm our ability to manufacture our products until a new source of supply, if any, could be found. We may be unable to find a sufficient alternative supply channel in a reasonable time period or on commercially reasonable terms, if at all, which would have a material adverse effect on our business, results of operations and financial condition.

Our sales may be materially adversely impacted by the coronavirus.

Our current Advanced Wound Care portfolio is sold throughout the United States via an experienced direct sales force, which focuses its efforts on outpatient wound care. We use a mix of direct sales representatives and independent agencies to service the Surgical & Sports Medicine market. These sales representatives are supported by teams of professionals focused on sales management, sales operations and effectiveness, ongoing training, analytics and marketing.

Our direct sales force functions by meeting in person with physicians and health care providers to discuss our products. COVID-19 may negatively affect demand for our products by limiting the ability of our sales personnel to maintain their customary contacts with physicians and health care providers. We may also find that the independent agencies that we use will have to prioritize their workload and may be forced to slow their activities as a result of COVID-19. As a result, we cannot assure you that our direct sales representatives or independent agencies will increase or maintain our current sales levels, which could have a material adverse effect on our business, results of operations, financial condition and cash flows. The support for our sales force may also be impacted, thereby reducing the effectiveness of our sales force.

We may also experience significant and unpredictable reductions in demand for certain of our products if patients are unable to access certain advanced therapies due to stay-at-home orders or providers prioritizing resources to address the COVID-19 pandemic.

The impact of COVID-19 on economic activity, and its effect on our manufacturing facilities, supply chain and sales force is uncertain at this time and could have a material adverse effect on our results, especially to the extent theses effects persist or exacerbate over an extended period of time.

Our ability to comply with financial covenants under our credit agreement and raise capital may be materially adversely impacted by COVID-19.

We have funded our operations and capital spending, in part, through third party debt and proceeds from the saleshares of our Class A common stock. Our 2019 Credit Agreement requiresstock to its members, we ceased to be a controlled company within the meaning of the Nasdaq rules. The Nasdaq rules exempt controlled companies from certain governance requirements including (i) the requirement that wea majority of the board of directors consist of independent directors, (ii) the requirement to have a nominating and corporate governance committee that is composed entirely of independent directors with a written charter addressing the committee’s purpose and responsibilities or independent director involvement in the selection of director nominees, by having director nominees selected or recommended by a majority of its independent directors meeting in executive session and (iii) the requirement to have a compensation committee that is composed entirely of independent directors with a written charter addressing the committee’s purpose and responsibilities.

Under the Nasdaq rules, a company that ceases to be a controlled company must comply with certain financial covenants that include maintaining Minimum Trailing Twelve Month Consolidated Revenuethe independent board committee requirements as they relate to the nominating and Non-PuraPly Revenue, each tested quarterly. Ifcorporate governance committee (if applicable) and compensation committee on the following
phase-in
schedule: (1) one independent committee member at the time it ceases to be a controlled company, (2) a majority of independent committee members within 90 days of the date it ceases to be a controlled company and (3) all independent committee members within one year of the date it ceases to be a controlled company. Additionally, the Nasdaq rules provide a
12-month
phase-in
period from the date a company ceases to be a controlled company to comply with the majority independent board requirement.
Accordingly, following the loss of controlled company status on May 6, 2021, our board of directors determined to have director nominees recommended by a majority of our independent directors meeting in executive session. In addition, one member of our compensation committee was independent on May 6, 2021, a majority of the members of our compensation committee were independent by August 4, 2021 and all of the members of the compensation committee must be independent by May 6, 2022. A majority of the members of our board of directors must be independent by May 6, 2022,
During these
phase-in
periods, our stockholders will not have the same protections afforded to stockholders of companies of which the majority of directors are independent and, if, within the
phase-in
periods, we are unablenot able to meet these financial covenants due to the economic impact of COVID-19recruit additional directors who would qualify as independent, or otherwise comply with the borrowings under the 2019 Credit AgreementNasdaq listing requirements, we may become duebe subject to enforcement actions by Nasdaq. In addition, a change in our board of directors and payable immediately unless we obtain an amendmentcommittee membership may result in a change in corporate strategy and operating philosophies, and may result in deviations from our lenders and we would be prohibited from making additional borrowings under the Revolving Facility if we have availably under that facility in the future. There can be no assurance that our lenders would agree to any such amendment on acceptable terms, or at all. In addition, any sustained disruption in the capital markets from the COVID-19 pandemic could negatively impact our ability to raise capital from the offeringcurrent growth strategy.
38

Table of equity or debt securities.

Contents

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

None.

Item 3. Defaults Upon Senior Securities

None.

Item 4. Mine Safety Disclosures

Not Applicable.

Item 5. Other Information

On November 3, 2020, Albert Erani and Maurice Ades each resigned as a member

None.
39

Table of the Company’s board of directors effective immediately. Mr. Erani was also a member of the compensation committee. Neither Mr. Erani nor Mr. Ades resigned as a result of a disagreement with the Company on any matter relating to its operations, policies or practices.

On November 3, 2020, the board of directors elected David Erani, 32, to fill the vacancy created by Albert Erani’s resignation and Robert Ades, 47, to fill the vacancy created by Maurice Ades’ resignation. David Erani was nominated for election to the board of directors by his father, Albert Erani, and Robert Ades was nominated for election to the board of directors by his father, Alan Ades, pursuant to the terms of the Controlling Stockholders Agreement among the Company, Alan Ades, Albert Erani and Glenn Nussdorf, current and former members of the board of directors, together with Dennis Erani, Starr Wisdom and certain of their respective affiliates, who control a majority of the voting power of the Company’s outstanding Class A common stock. David Erani and Robert Ades will have the benefit of the Company’s standard form of indemnification agreement, but will not receive any compensation for their service on the board of directors.

In connection with these changes to the board’s composition, the board of directors appointed Art Leibowitz as a member of the compensation committee. Following Mr. Leibowitz’s appointment, the members of the compensation committee include Wayne Mackie (chair), Mr. Leibowitz and Alan Ades. The members of the audit committee are unchanged and include Mr. Leibowitz (chair), Mr. Mackie and Josh Tamaroff.

Contents

Item 6. Exhibits

Exhibit
number
  

Description

3.1  Certificate of Incorporation of Organogenesis Holdings Inc. (incorporated by reference to Exhibit 3.1 to the Company’s Registration Statement on Form S-3/A (File No. 333-233621) filed with the SEC on September 16, 2019)
3.2  Bylaws of Organogenesis Holdings Inc. (incorporated by reference to Exhibit 3.2 to the Company’s Registration Statement on Form S-3/A (File No. 333-233621) filed with the SEC on September 16, 2019)
10.1  Separation LetterFifth Amendment to Credit Agreement dated August  24, 2020, betweenand effective as of May 5, 2021 among Organogenesis Holdings Inc., Organogenesis Inc. and Timothy M. CunninghamPrime Merger Sub, LLC, collectively as borrower, and Silicon Valley Bank, in its capacity as the Issuing Lender and Swingline Lender, Silicon Valley Bank, as Administrative Agent, and Silicon Valley Bank and the other lenders listed therein, collectively as Lenders (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K (File No. 001-37906)filed with the SEC on August 24, 2020)May 10, 2021)
10.2*Change in Control Retention Agreement between Organogenesis Holdings Inc. and Gary S. Gillheeney, Sr. effective as of May 10, 2021 (incorporated by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q (File No. 001-37906) filed with the SEC on May 10, 2021)
10.3*Form of Change in Control Retention Agreement (Non-CEO Executive Officers) (incorporated by reference to Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q (File No. 001-37906) filed with the SEC on May 10, 2021)
10.4*Form of Change in Control Retention Agreement (Independent Directors) (incorporated by reference to Exhibit 10.4 to the Company’s Quarterly Report on Form 10-Q (File No. 001-37906) filed with the SEC on May 10, 2021)
31.1†  Certification of Principal Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2†  Certification of Principal Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1†  Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101.INS†  Inline XBRL Instance Document XBRL
101.SCH†  Inline XBRL Taxonomy Extension Schema Document
101.CAL†  Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF†  Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB†  Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE†  Inline XBRL Taxonomy Extension Presentation Linkbase Document
104Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).

Filed herewith

*
Management contract or compensatory plan or arrangement

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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.

Dated: NovemberAugust 9, 20202021  Organogenesis Holdings Inc.
  (Registrant)
  

/s/ Henry Hagopian

  

Henry Hagopian

/s/ David Francisco
  

Interim

David Francisco
Chief Financial Officer

  

(Principal Financial and Accounting Officer)

43

41