Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM

10-Q

(Mark One)

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

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

For the Quarter

ly
Quarterly Period Ended March 31, 2022
2023

OR

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

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

Commission File Number:

Number 001-37906

ORGANOGENESIS HOLDINGS INC.

(Exact Name of Registrant as Specified in Its Charter)

Delaware

98-1329150

(State or Other Jurisdiction of

(I.R.S. Employer

Incorporation or Organization)

(I.R.S. Employer

Identification No.)

85 Dan Road

Canton, MA

02021

(Address

Canton, MA

02021

                                    (Address of principal executive offices)

(Zip Code)

(781)

(781) 575-0775

(Registrant’s Telephone Number, Including Area Code)

Not Applicable

(Former name, former address and former fiscal year, if changed since last report)

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

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

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

The number of shares of the registrant’s Class A common stock outstanding as of May 1, 20222023 was 129,130,179.

131,261,833.


Table of Contents


Table of Contents

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on

Form 10-Q
(this (this “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
and in “Part I, Item 1A—Risk Factors” in our Annual Report on Form
10-K
for the year ended December 31, 2021.2022. 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 SECU.S. Securities and Exchange Commission (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


Table of Contents

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)

   
March 31,
  
December 31,
 
   
2022
  
2021
 
Assets
         
Current assets:         
Cash
 and cash equivalents
  $107,897  $113,929 
Restricted cash   605   599 
Accounts receivable, net   79,477   82,460 
Inventory
, net
   22,737   25,022 
Prepaid expenses and other current assets   7,135   4,969 
          
Total current assets   217,851   226,979 
Property and equipment, net   84,268   79,160 
Intangible assets, net   24,452   25,673 
Goodwill   28,772   28,772 
Operating lease
right-of-use
assets, net
   47,468   49,144 
Deferred tax asset, net   31,994   31,994 
Other assets   1,467   1,537 
          
Total assets  $436,272  $443,259 
          
Liabilities and Stockholders’ Equity
         
Current liabilities:         
D
eferred acquisition consideration
  $1,436  $1,436 
Current portion of term loan   3,126   2,656 
F
inance lease obligations
   101   200 
Current portion of operating lease obligations   11,775   11,785 
Accounts payable   27,935   29,339 
Accrued expenses and other current liabilities   32,419   36,589 
          
Total current liabilities   76,792   82,005 
Term loan, net of current portion   69,869   70,769 
Operating lease obligations, net of current portion   45,323   46,893 
Other liabilities   1,060   1,557 
          
Total liabilities   193,044   201,224 
          
Commitments and contingencies (Note 18)       
Stockholders’ equity:         
Preferred stock, $0.0001 par value; 1,000,000 shares authorized; NaN issued   0—     0—   
Common stock, $0.0001 par value; 400,000,000 shares authorized; 129,615,732 and 129,408,740 shares issued; 128,887,184 and 128,680,192 shares outstanding at March 31, 2022 and December 31, 2021, respectively.   13   13 
Additional
paid-in
capital
   303,261   302,155 
Accumulated deficit   (60,046  (60,133
          
Total stockholders’ equity   243,228   242,035 
          
Total liabilities and stockholders’ equity  $436,272  $443,259 
          

 

 

March 31,

 

 

December 31,

 

 

 

2023

 

 

2022

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

88,694

 

 

$

102,478

 

Restricted cash

 

 

721

 

 

 

812

 

Accounts receivable, net

 

 

92,021

 

 

 

89,450

 

Inventory, net

 

 

25,539

 

 

 

24,783

 

Prepaid expenses and other current assets

 

 

9,847

 

 

 

5,086

 

Total current assets

 

 

216,822

 

 

 

222,609

 

Property and equipment, net

 

 

106,637

 

 

 

102,463

 

Intangible assets, net

 

 

19,560

 

 

 

20,789

 

Goodwill

 

 

28,772

 

 

 

28,772

 

Operating lease right-of-use assets, net

 

 

42,839

 

 

 

43,192

 

Deferred tax asset, net

 

 

30,014

 

 

 

30,014

 

Other assets

 

 

1,463

 

 

 

1,520

 

Total assets

 

$

446,107

 

 

$

449,359

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Current portion of term loan

 

$

5,009

 

 

$

4,538

 

Current portion of operating lease obligations

 

 

12,160

 

 

 

11,708

 

Accounts payable

 

 

30,310

 

 

 

32,330

 

Accrued expenses and other current liabilities

 

 

28,597

 

 

 

26,447

 

Total current liabilities

 

 

76,076

 

 

 

75,023

 

Term loan, net of current portion

 

 

64,860

 

 

 

66,231

 

Operating lease obligations, net of current portion

 

 

40,325

 

 

 

41,314

 

Other liabilities

 

 

1,145

 

 

 

1,122

 

Total liabilities

 

 

182,406

 

 

 

183,690

 

Commitments and contingencies (Note 18)

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

Preferred stock, $0.0001 par value; 1,000,000 shares authorized; none issued

 

 

-

 

 

 

-

 

Common stock, $0.0001 par value; 400,000,000 shares authorized; 131,954,935 and 131,647,677 shares issued; 131,226,387 and 130,919,129 shares outstanding at March 31, 2023 and December 31, 2022, respectively.

 

 

13

 

 

 

13

 

Additional paid-in capital

 

 

312,573

 

 

 

310,957

 

Accumulated deficit

 

 

(48,885

)

 

 

(45,301

)

Total stockholders’ equity

 

 

263,701

 

 

 

265,669

 

Total liabilities and stockholders’ equity

 

$

446,107

 

 

$

449,359

 

The accompanying notes are an integral part of these unaudited consolidated financial statements.

4


ORGANOGENESIS HOLDINGS INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited)

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


   
Three Months Ended

March 31,
 
   
2022
  
2021
 
Net revenue  $98,117  $102,552 
Cost of goods sold   25,080   25,495 
          
Gross profit   73,037   77,057 
Operating expenses:         
Selling, general and administrative   63,578   58,232 
Research and development   8,587   6,209 
          
Total operating expenses   72,165   64,441 
          
Income from operations   872   12,616 
          
Other expense, net:         
Interest expense   (737  (2,470
Other expense, net   (3  (3
          
Total other expense, net   (740  (2,473
          
Net income before income taxes   132   10,143 
Income tax expense   (45  (200
          
Net income  $87  $9,943 
          
Net income, per share:         
Basic  $0.00  $0.08 
          
Diluted  $0.00  $0.07 
          
Weighted-average common shares outstanding         
Basic   128,788,721   127,870,065 
          
Diluted   132,805,154   133,451,950 
          

 

 

Three Months Ended
March 31,

 

 

 

2023

 

 

2022

 

Net revenue

 

$

107,642

 

 

$

97,117

 

Cost of goods sold

 

 

26,607

 

 

 

25,080

 

Gross profit

 

 

81,035

 

 

 

72,037

 

Operating expenses:

 

 

 

 

 

 

Selling, general and administrative

 

 

73,834

 

 

 

63,578

 

Research and development

 

 

11,202

 

 

 

8,587

 

Total operating expenses

 

 

85,036

 

 

 

72,165

 

Loss from operations

 

 

(4,001

)

 

 

(128

)

Other expense, net:

 

 

 

 

 

 

Interest expense

 

 

(649

)

 

 

(737

)

Other income (expense), net

 

 

23

 

 

 

(3

)

Total other expense, net

 

 

(626

)

 

 

(740

)

Net loss before income taxes

 

 

(4,627

)

 

 

(868

)

Income tax benefit (expense)

 

 

1,658

 

 

 

(45

)

Net loss

 

$

(2,969

)

 

$

(913

)

 

 

 

 

 

 

 

Net loss, per share:

 

 

 

 

 

 

Basic

 

$

(0.02

)

 

$

(0.01

)

Diluted

 

$

(0.02

)

 

$

(0.01

)

Weighted-average common shares outstanding

 

 

 

 

 

 

Basic

 

 

131,083,841

 

 

 

128,788,721

 

Diluted

 

 

131,083,841

 

 

 

128,788,721

 

The accompanying notes are an integral part of these unaudited consolidated financial statements.

5


Table of Contents

ORGANOGENESIS HOLDINGS INC.

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(unaudited)

(amounts in thousands, except share data)


   
Three Months Ended March 31, 2022
 
           
Additional
       
   
Common Stock
   
Paid-in
  
Accumulated
  
Total
 
   
Shares
   
Amount
   
Capital
  
Deficit
  
Stockholders’ Equity
 
Balance as of December 31, 2021
   128,680,192   $13   $302,155  $(60,133 $242,035 
Exercise of stock options   86,121    —      291   —     291 
Vesting of RSUs, net of shares surrendered to pay taxes   120,871    —      (488  —     (488
Stock-based compensation expense   —      —      1,303   —     1,303 
Net income   —      —      —     87   87 
                        
Balance as of March 31, 2022
   128,887,184    13    303,261   (60,046  243,228 
                        
   
Three Months Ended March 31, 2021
 
           
Additional
       
   
Common Stock
   
Paid-in
  
Accumulated
  
Total
 
   
Shares
   
Amount
   
Capital
  
Deficit
  
Stockholders’ Equity
 
                        
Balance as of December 31, 2020 
   127,731,833    13    296,830   (155,035  141,808 
Exercise of stock options   285,344    —      984   —     984 
Vesting of RSUs, net of shares surrendered to pay taxes   85,078    —      (417  —     (417
Stock-based compensation expense   —      —      698   —     698 
Net income   —      —      —     9,943   9,943 
                        
Balance as of March 31, 2021 
   128,102,255   $13   $298,095  $(145,092 $153,016 
                        

 

 

Three Months Ended March 31, 2023

 

 

 

 

 

 

 

 

 

Additional

 

 

 

 

 

 

 

 

 

Common Stock

 

 

Paid-in

 

 

Accumulated

 

 

Total

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Stockholders’ Equity

 

Balance as of December 31, 2022

 

 

130,919,129

 

 

$

13

 

 

$

310,957

 

 

$

(45,301

)

 

$

265,669

 

Cumulative effect of adopting new accounting principle ASU 2016-13

 

 

 

 

 

 

 

 

 

 

$

(615

)

 

 

(615

)

Vesting of RSUs, net of shares surrendered to pay taxes

 

 

307,258

 

 

 

-

 

 

 

(298

)

 

 

-

 

 

 

(298

)

Stock-based compensation expense

 

 

-

 

 

 

-

 

 

 

1,914

 

 

 

-

 

 

 

1,914

 

Net income

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(2,969

)

 

 

(2,969

)

Balance as of March 31, 2023

 

 

131,226,387

 

 

$

13

 

 

$

312,573

 

 

$

(48,885

)

 

$

263,701

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended March 31, 2022

 

 

 

 

 

 

 

 

 

Additional

 

 

 

 

 

 

 

 

 

Common Stock

 

 

Paid-in

 

 

Accumulated

 

 

Total

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Stockholders’ Equity

 

Balance as of December 31, 2021

 

 

128,680,192

 

 

$

13

 

 

$

302,155

 

 

$

(60,833

)

 

$

241,335

 

Exercise of stock options

 

 

86,121

 

 

 

-

 

 

 

291

 

 

 

-

 

 

 

291

 

Vesting of RSUs, net of shares surrendered to pay taxes

 

 

120,871

 

 

 

 

 

 

(488

)

 

 

 

 

 

(488

)

Stock-based compensation expense

 

 

-

 

 

 

-

 

 

 

1,303

 

 

 

-

 

 

 

1,303

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(913

)

 

 

(913

)

Balance as of March 31, 2022

 

 

128,887,184

 

 

$

13

 

 

$

303,261

 

 

$

(61,746

)

 

$

241,528

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The accompanying notes are an integral part of these unaudited consolidated financial statements.

6

ORGANOGENESIS HOLDINGS INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)

(amounts in thousands)


   
Three Months Ended

March 31,
 
   
2022
  
2021
 
Cash flows from operating activities:
         
Net income  $87  $9,943 
Adjustments to reconcile net income to net cash provided by (used in) operating activities:         
Depreciation   1,347   1,010 
Amortization of intangible assets   1,221   1,243 
Amortization of operating lease
right-of-use
assets
   1,847   1,129 
Non-cash
interest expense
   108   72 
Deferred interest expense   151   525 
Provision recorded for doubtful accounts   40   921 
Loss on disposal of property and equipment   0     239 
Adjustment for excess and obsolete inventories   2,205   2,290 
Stock-based compensation   1,303   698 
Change in fair value of Earnout liability   0     (296
Changes in operating assets and liabilities:         
Accounts receivable   2,942   (16,119
Inventory   80   (4,212
Prepaid expenses and other current assets   (2,165  (622
Operating leases   (1,751  (1,210
Accounts payable   (1,186  1,842 
Accrued expenses and other current liabilities   (4,828  1,411 
Other liabilities   10     (164
          
Net cash provided by (used in) operating activities   1,411   (1,300
Cash flows from investing activities:
         
Purchases of property and equipment   (6,672  (4,957
          
Net cash used in investing activities   (6,672  (4,957
Cash flows from financing activities:
         
Payments of term loan   (469  0   
Payments of withholding taxes in connection with RSUs vesting   (488  (417
Proceeds from the exercise of stock options   291   984 
Principal repayments of finance lease obligations   (99  (675
Payment of deferred acquisition consideration   0     (483
          
Net cash used in financing activities   (765  (591
Change in cash
, cash equivalents,
and restricted cash
   (6,026  (6,848
Cash
, cash equivalents,
and restricted cash, beginning of period
   114,528   84,806 
          
Cash
, cash equivalents,
and restricted cash, end of period
  $108,502  $77,958 
          
Supplemental disclosure of cash flow information:
         
Cash paid for interest  $627  $1,937 
Cash paid for income taxes  $4  $0   
Supplemental disclosure of
non-cash
investing and financing activities:
         
Purchases of property and equipment included in accounts payable and accrued expenses  $1,869  $306 
Right-of-use
assets obtained through operating lease obligations
  $171  $310 

 

 

Three Months Ended
March 31,

 

 

 

2023

 

 

2022

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$

(2,969

)

 

$

(913

)

Adjustments to reconcile net loss to net cash provided by (used in) operating activities:

 

 

 

 

 

 

Depreciation

 

 

2,694

 

 

 

1,347

 

Amortization of intangible assets

 

 

1,230

 

 

 

1,221

 

Reduction in the carrying value of right-of-use assets

 

 

1,939

 

 

 

1,847

 

Non-cash interest expense

 

 

107

 

 

 

108

 

Deferred interest expense

 

 

122

 

 

 

151

 

Provision recorded for credit losses

 

 

243

 

 

 

40

 

Loss on disposal of property and equipment

 

 

63

 

 

 

-

 

Adjustment for excess and obsolete inventories

 

 

1,407

 

 

 

2,205

 

Stock-based compensation

 

 

1,914

 

 

 

1,303

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Accounts receivable

 

 

(3,429

)

 

 

2,942

 

Inventory

 

 

(2,163

)

 

 

80

 

Prepaid expenses and other current assets

 

 

(4,774

)

 

 

(2,165

)

Operating leases

 

 

(2,122

)

 

 

(1,751

)

Accounts payable

 

 

(1,390

)

 

 

(1,186

)

Accrued expenses and other current liabilities

 

 

2,029

 

 

 

(3,828

)

Other liabilities

 

 

22

 

 

 

10

 

Net cash provided by (used in) operating activities

 

 

(5,077

)

 

 

1,411

 

Cash flows from investing activities:

 

 

 

 

 

 

Purchases of property and equipment

 

 

(7,562

)

 

 

(6,672

)

Net cash used in investing activities

 

 

(7,562

)

 

 

(6,672

)

Cash flows from financing activities:

 

 

 

 

 

 

Payments of term loan under the 2021 Credit Agreement

 

 

(938

)

 

 

(469

)

Payments of withholding taxes in connection with RSUs vesting

 

 

(298

)

 

 

(488

)

Proceeds from the exercise of stock options

 

 

-

 

 

 

291

 

Principal repayments of finance lease obligations

 

 

-

 

 

 

(99

)

Net cash used in financing activities

 

 

(1,236

)

 

 

(765

)

Change in cash, cash equivalents and restricted cash

 

 

(13,875

)

 

 

(6,026

)

Cash, cash equivalents, and restricted cash, beginning of period

 

 

103,290

 

 

 

114,528

 

Cash, cash equivalents, and restricted cash, end of period

 

$

89,415

 

 

$

108,502

 

Supplemental disclosure of cash flow information:

 

 

 

 

 

 

Cash paid for interest

 

$

1,271

 

 

$

627

 

Cash paid for income taxes

 

$

128

 

 

$

4

 

Supplemental disclosure of non-cash investing and financing activities:

 

 

 

 

 

 

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

 

$

1,986

 

 

$

1,869

 

Right-of-use assets obtained through operating lease obligations

 

$

1,586

 

 

$

171

 

The accompanying notes are an integral part of these unaudited consolidated financial statements.

7


ORGANOGENESIS HOLDINGS INC.

NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS

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

1. Nature of 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. Several of the existing and pipeline products in the Company’s portfolio have Premarket Application (“PMA”) 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 1one operating and reportable segment.

COVID-19

pandemic
The coronavirus
(COVID-19)
pandemic around

On April 10, 2023, President Biden signed a joint congressional resolution ending the world,national emergency related to COVID-19 and particularly in the United States, continuesBiden Administration previously announced it will end the public health emergency declaration related to present risks to the Company.COVID-19 on May 11, 2023. While the

COVID-19
pandemic has not materially adversely affected the Company’s financial results and business operations through March 31, 2022,2023, the COVID-19 pandemic continues to present risks to the Company, and the Company is unable to predict the impact that
COVID-19
(including the emergence of new variants) will have on its financial position and operating results because ofin the numerous uncertainties created by the unprecedented nature of the pandemic.future.

The Company is closely 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.

2. 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 Company’s Annual Report on Form

10-K
for the fiscal year ended December 31, 2021, as amended2022 (the “Annual Report”). There have been no material changes to the significant accounting policies previously disclosed in the Annual Report.

Unaudited Interim Financial Information

The accompanying unaudited consolidated financial statements have been prepared by management in accordance with GAAPgenerally accepted accounting principles in the United States (“GAAP”), and the rules and regulations of the Securities and Exchange Commission (the “SEC”)SEC regarding interim financial reporting. Accordingly, they do not include all the information and footnotes required by generally accepted accounting principlesGAAP 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 Annual Report.

The unaudited consolidated financial statements include the accounts and results of operations of Organogenesis Holdings Inc. and its wholly-owned 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 three months ended March 31, 20222023 are not necessarily indicative of the results to be expected for the year ending December 31, 2022,2023, 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, disclosure of contingent assets and liabilities at the date of the financial statements and the reported results of operations during the reporting periods. In preparing the consolidated financial statements, the estimates and assumptions that management consider to be significant and that present the greatest amount of uncertainty include: revenue recognition; sales returns and credit losses; inventory reserve; recognition and measurement of current and deferred income tax assets and liabilities; the assessment of recoverability of long-lived and indefinite lived assets (including intangible assets); assessing impairment of goodwill; valuation of assets and liabilities that use unobservable inputs; and the valuation and recognition of stock-based compensation. Actual results and outcomes may differ significantly from those estimates and assumptions.

8


Recently Adopted Accounting Pronouncements
In December 2019,

Concentration of Credit Risk

Financial instruments that potentially subject the Financial Accounting Standards BoardCompany to concentration of credit risk consist of cash and cash equivalents. The Company invests its cash equivalents in highly rated money market funds. Deposits may exceed federally insured limits, and the Company is exposed to credit risk on deposits in the event of default by the financial institutions to the extent account balances exceed the amount insured by the Federal Deposit Insurance Corporation (“FASB”FDIC”) issued Accounting Standard Update (“ASU”)

No. 2019-12,
Income Taxes— Simplifying. However, the Accounting for Income Taxes
. The standard intends to simplifyCompany mitigates the risk by sweeping cash daily overnight and reduce the cost of accounting for income taxes. The new guidance removes certain exceptions for recognizing deferred taxes for foreign investments, the incremental approach to performing intraperiod allocation, and calculating income taxes in interim periods for year to date losses that exceed anticipated full year losses. The standard also adds guidancediversifies among financial institutions to reduce complexity in certain areas, including accounting for franchise taxes that are partially based on income, transactions with a government that result with a step up in the tax basis of goodwill, changes in tax law enacted during interim periods, and allocating taxes to members of a consolidated group which are not subject to tax. For public business entities, the amendments in ASU
2019-12
are effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020. Early adoption is permitted for all periods in which financial statements have not yet been issued, including interim periods. The Company adopted this standard on January 1, 2021 and noted no impact to the financial statements.
such exposure.

Recently Issued Accounting Pronouncements Not Yet Adopted

Credit Loss

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
FASB subsequently issued a few amendments to ASU 2016-13. 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 GAAPpreviously required under generally accepted accounting principles, with aan expected loss 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 Company adoptedthe 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. Asstandard as of January 1, 2023 using the modified retrospective method. Under this method, the Company was a smaller reporting company whenapplied the standard was issued,new credit loss measurement guidance to trade accounts receivable, the only financial asset of the Company took advantage ofthat is impacted by the extended transition period and will adopt this standardASU and the related improvements onupdates. The Company recorded a net reduction of $615 to the opening balance of retained earnings as the cumulative effect of initially applying the standard. Results for reporting periods beginning after 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
are presented in accordance with Topic 326. Prior period amounts have not been restated and the related impact on the Company’s consolidated financial statements.are reported in accordance with legacy GAAP requirements.

In March 2020, the FASB issued ASU
No. 2020-04,
Reference Rate Reform
 (Topic 848): Facilitation of the Effects of
 Reference Rate Reform
 on Financial Reporting
 (“ASU
2020-04”).
ASU
2020-04
provides temporary optional expedients and exceptions to the US GAAP guidance on contract modifications and hedge accounting to ease the financial reporting burdens related to the expected market transition from the London Interbank Offered Rate (LIBOR) and other interbank offered rates to alternative reference rates. In January 2021, the FASB issued ASU
No. 2021-01,
Reference Rate Reform
 (Topic 848): Scope
 (“ASU
2021-01”),
to clarify certain optional expedients and exceptions in Topic 848 for contract modifications and hedge accounting to apply to derivatives that are affected by the discounting transition. Both ASU
2020-04
and ASU
2021-01
are effective upon issuance through December 31, 2022. The Company’s debt agreement that utilizes LIBOR has conventional LIBOR replacement language. Since the debt agreement has not discontinued the use of LIBOR, this ASU is not yet effective for the Company. To the extent the interest rate changes to the rate specified in the debt agreement, the Company will utilize the relief in this ASU. The Company evaluated the effects of adopting the provisions of ASU
2020-04
and ASU
2021-01
and does not expect a material impact on the Company’s consolidated financial statements.

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$19,024 as of the Acquisition Date, consisting of $6,427$6,427 in cash, 2,151,438 shares of the Company’s Class A common stock with a fair value of $8,815,$8,815, and contingent consideration (the “Earnout”) with a fair value of $3,782.$3,782. On the Acquisition Date, the Company paid $5,820$5,820 in cash and issued 1,947,953 shares of the Company’s Class A common stock. The remaining consideration of $1,436$1,436 was held back and was released in April 2022 by the Company paying additional $739$608 in cash and issuing additional 203,485 shares of the Company’s Class A common stock to the former

equityholders
equity holders of CPN.
9

The Company iswas obligated to pay the Earnout to CPN’s former

equityholders
equity holders if CPN’s legacy product revenue in the Earnout Period (July 1, 2021 to June 30, 2022), exceedsexceeded CPN’s 2019 revenue. The amount of the Earnout, if any, willwould be equal to 70%70% of the excess and willwould be payable 60 days after the expiration of the Earnout Period. The Company recorded a
non-current
liability of $3,782 on the Acquisition Date for the fair valueAs of the contingent consideration relatedconclusion of the Earnout Period on June 30, 2022, the Company calculated the Earnout liability to be $
0. During the expected Earnout. TheEarnout Period, the Company assessesassessed the fair value of the Earnout liability at each reporting period. As of March 31, 2022, the Earnout liability was estimated at $0 as a result of the Company’s updated assessment of the near-term market for the CPN product portfolio. Subsequent changes in the estimated fair value of the liability arewere reflected in earnings until the liability iswas settled. See Note “5. Fair Value Measurement of Financial
Assets and Liabilities”.
Liabilities.”

4. Product and Geographic Sales

Revenue

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 is the Company’s promise to transfer the Company’s products to customers based on specific payment and shipping terms 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 March 31, 20222023 and 2021,2022, the Company recorded GPO fees of $619$1,424 and $700,$1,619, respectively, as a direct reduction of revenue.

9


Table of Contents

The following tables set forth revenue by product category:

 

 

Three Months Ended
March 31,

 

 

 

2023

 

 

2022

 

Advanced Wound Care

 

$

100,917

 

 

$

90,090

 

Surgical & Sports Medicine

 

 

6,725

 

 

 

7,027

 

Total net revenue

 

$

107,642

 

 

$

97,117

 

   
Three Months Ended

March 31,
 
   
2022
   
2021
 
Advanced Wound Care  $90,950   $90,708 
Surgical & Sports Medicine   7,167    11,844 
           
Total net revenue  $98,117   $102,552 
           

For all periods presented, net revenue generated outside the United States represented less than 1%1% of total net revenue.

5. Fair Value

Measurement
of Financial Assets and Liabilities
As of March 31, 2022 and December 31, 2021, the Company’s financial assets and liabilities measured at fair value on a recurring basis only included the Earnout liability as discussed below.

Earnout Liability

In connection with accounting for the CPN acquisition on September 17, 2020, the Company recorded an Earnout liability of $3,782$3,782 on the Acquisition Date, representing the fair value of contingent consideration payable upon the achievement of a certain revenue target. The Earnout liability iswas classified as a Level 3 measurement within the fair value hierarchy for which fair value iswas derived from inputs that arewere unobservable and significant to the overall fair value measurement. The fair value of such Earnout liability iswas estimated using a Monte Carlo simulation model that utilizesutilized key assumptions including forecasted revenues and volatilities of the underlying financial metrics during the Earnout Period. ThePeriod that ended on June 30, 2022. Before its settlement, the Company assessesassessed the fair value of the Earnout liability at each reporting period. Any subsequent changes in the estimated fair value of the liability arewere reflected in selling, general and administrative expenses until the liability iswas settled. Since September 30, 2021, the Earnout liability remained at $0 through its settlement. For more information about the Earnout liability, refer to Note “3. Acquisition”. As of December 31, 2021 and March 31, 2022, the Earnout liability was $0 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: 
   
Three Months Ended

March 31,
 
   
2022
   
2021
 
Beginning balance
  $0     $3,985 
Change in fair value
   0      (296
           
Ending balance
  $0     $3,689 
           

10

Acquisition.”

The Company did not have any financial assets a

nd
and liabilities measured at fair value on a
non-recurring
basis as of March 31, 2022 or2023 and December 31, 2021.2022.

6. Accounts Receivable, Net

Accounts receivable consisted of the following:

 

 

March 31,

 

 

December 31,

 

 

 

2023

 

 

2022

 

Accounts receivable

 

$

98,942

 

 

$

95,812

 

Less — allowance for credit losses

 

 

(6,921

)

 

 

(6,362

)

 

$

92,021

 

 

$

89,450

 

   
March 31
   
December 31,
 
   
2022
   
2021
 
Accounts receivable  $84,604   $87,613 
Less — allowance for doubtful accounts   (5,127   (5,153
           
   $79,477   $82,460 
           
 

The Company’s allowance for doubtful accountscredit losses was comprised of the following:

 

 

Three Months Ended
March 31,

 

 

 

2023

 

 

2022

 

Balance at beginning of period

 

$

6,362

 

 

$

5,153

 

Cumulative effect of adopting ASU 2016-13

 

 

615

 

 

 

-

 

Additions

 

 

243

 

 

 

40

 

Write-offs

 

 

(299

)

 

 

(66

)

Balance at end of period

 

$

6,921

 

 

$

5,127

 

10


Table of Contents

                                
   
Three Months Ended

March 31,
 
   
2022
   
2021
 
Balance at beginning of period  $5,153   $2,669 
Additions    40    921 
Write-offs   (66   (14
           
Balance at end of period  $5,127   $3,576 
           

7. Inventories

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

 

 

March 31,

 

 

December 31,

 

 

 

2023

 

 

2022

 

Raw materials

 

$

13,126

 

 

$

12,282

 

Work in process

 

 

1,158

 

 

 

1,022

 

Finished goods

 

 

11,255

 

 

 

11,479

 

 

 

$

25,539

 

 

$

24,783

 

   
March 31,
   
December 31,
 
   
2022
   
2021
 
Raw materials  $9,524   $9,023 
Work in process   995    991 
Finished goods   12,218    15,008 
           
   $22,737   $25,022 
           

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 forecasts and historical sales as compared to inventory level, and working with operations to maximize recovery of excess inventory. During the three months ended March 31, 20222023 and 2021,2022, the Company charged $2,205$1,407 and $2,290,$2,205, 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:

 

 

March 31,
2023

 

 

December 31,
2022

 

Subscriptions

 

$

5,334

 

 

$

4,211

 

Conferences and marketing expenses

 

 

1,277

 

 

 

106

 

Deposits

 

 

652

 

 

 

635

 

Insurance

 

 

2,519

 

 

 

54

 

Other

 

 

65

 

 

 

80

 

 

$

9,847

 

 

$

5,086

 

   
March 31,

2022
   
December 31,

2021
 
Subscriptions  $2,685   $2,745 
Conferences and marketing expenses   2,060    538 
Deposits   1,344    1,216 
Insurance   1,001    358 
Other   45    112 
           
   $7,135   $4,969 
           

Deposits are funds held by vendors which are expected to be released within twelve months and therefore they are recorded as current assets.


11

9. Property and Equipment, Net

Property and equipment consisted of the following:

 

 

March 31,

 

 

December 31,

 

 

 

2023

 

 

2022

 

Leasehold improvements

 

$

52,369

 

 

$

37,607

 

Buildings

 

 

4,943

 

 

 

4,943

 

Furniture, computers and equipment

 

 

58,282

 

 

 

57,147

 

 

 

115,594

 

 

 

99,697

 

Accumulated depreciation

 

 

(65,490

)

 

 

(62,798

)

Construction in progress

 

 

56,533

 

 

 

65,564

 

 

$

106,637

 

 

$

102,463

 

   
March 31,
2022
   
December 31,
2021
 
Leasehold improvements  $33,973   $30,531 
Buildings   4,943    4,943 
Furniture, computers and equipment   54,822    53,959 
           
    93,738    89,433 
Accumulated depreciation and amortization   (59,075   (57,729
Construction in progress   49,605    47,456 
           
   $84,268   $79,160 
           

Depreciation expense was $1,347$2,694 and $1,010,$1,347 for the three months ended March 31, 2023 and 2022, and 2021, respectively.

Construction in progress primarily represents unfinished c
ons
tructionconstruction work on a purchased building located on the Company’s Canton, Massachusetts campus and improvements at the Company’s leased facilities in Canton and Norwood, Massachusetts.

11


Table of Contents

10. Goodwill and Intangible Assets

Goodwill was $28,772$28,772 as of March 31, 20222023 and December 31, 2021.

2022.

Identifiable intangible assets consisted of the following as of March 31, 2022: 

   
Original
Cost
   
Accumulated
Amortization
   
Net Book
Value
 
Developed technology  $32,620   $(18,573  $14,047 
Trade names and trademarks   2,080    (1,236   844 
Customer relationships   10,690    (1,648   9,042 
Independent sales agency network   4,500    (4,500   —   
Patent   7,623    (7,623   —   
Non-compete
agreements
   1,010    (491   519 
                
Total  $58,523   $(34,071  $24,452 
                
2023:

 

 

Original

 

 

Accumulated

 

 

Net Book

 

 

 

Cost

 

 

Amortization

 

 

Value

 

Developed technology

 

$

32,620

 

 

$

(22,040

)

 

$

10,580

 

Trade names and trademarks

 

 

2,080

 

 

 

(1,442

)

 

 

638

 

Customer relationships

 

 

10,690

 

 

 

(2,717

)

 

 

7,973

 

Independent sales agency network

 

 

4,500

 

 

 

(4,500

)

 

 

-

 

Patent

 

 

7,623

 

 

 

(7,623

)

 

 

-

 

Non-compete agreements

 

 

1,010

 

 

 

(641

)

 

 

369

 

Total

 

$

58,523

 

 

$

(38,963

)

 

$

19,560

 

Identifiable intangible assets consisted of the following as of December 31, 2021: 2022:

 

 

Original

 

 

Accumulated

 

 

Net Book

 

 

 

Cost

 

 

Amortization

 

 

Value

 

Developed technology

 

$

32,620

 

 

$

(21,164

)

 

$

11,456

 

Trade names and trademarks

 

 

2,080

 

 

 

(1,393

)

 

 

687

 

Customer relationship

 

 

10,690

 

 

 

(2,450

)

 

 

8,240

 

Independent sales agency network

 

 

4,500

 

 

 

(4,500

)

 

 

-

 

Patent

 

 

7,623

 

 

 

(7,623

)

 

 

-

 

Non-compete agreements

 

 

1,010

 

 

 

(604

)

 

 

406

 

Total

 

$

58,523

 

 

$

(37,734

)

 

$

20,789

 

   
Original
Cost
   
Accumulated
Amortization
   
Net Book
Value
 
Developed technology  $32,620   $(17,709  $14,911 
Trade names and trademarks   2,080    (1,183   897 
Customer relationship   10,690    (1,381   9,309 
Independent sales agency network   4,500    (4,500   —   
Patent   7,623    (7,623   —   
Non-compete
agreements
   1,010    (454   556 
                
Total  $58,523   $(32,850  $25,673 
                

Amortization of intangible assets, calculated on a straight-line basis or using an accelerated method, was $1,221$1,230 and $1,243$1,221 for the three months ended March 31, 2023 and 2022, and 2021, respectively.


12

11. Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consisted of the following:

 

 

March 31,

 

 

December 31,

 

 

 

2023

 

 

2022

 

Personnel costs

 

$

22,049

 

 

$

17,113

 

Royalties

 

 

3,041

 

 

 

3,320

 

Accrued but unpaid lease obligations and interest

 

 

1,960

 

 

 

2,463

 

Accrued taxes

 

 

771

 

 

 

2,625

 

Other

 

 

776

 

 

 

926

 

 

$

28,597

 

 

$

26,447

 

   
March 31,
2022
   
December 31,
2021
 
Personnel costs  $23,060   $26,865 
Royalties   3,190    3,458 
Accrued but unpaid lease obligations and interest   3,981    3,963 
Other   2,188    2,303 
           
   $32,419   $36,589 
           

The accrued but unpaid lease obligations and the interest accrual on these obligations are related to the buildings in Canton, Massachusetts. See Note “17. Leases”.

Leases.”

12. Restructuring

In order to reduce the Company’s cost structure and achieveimprove operating efficiency, the Company is consolidatingconsolidates its manufacturing operations in various locations into Massachusetts facilities.

On October 21, 2020, the Company committed to a plan to restructure theits workforce and operations in its La Jolla, California facilities. The restructuring involved approximately 

65 employees and was substantially completed as of December 31, 2021, with certain facility and storage activities continuing through 2024.
 
On March 9, 2022, the Company committed
to
a plan to restructure theits workforce and operations in its Birmingham, Alabama facilities. The restructuring is expectedinvolved 24 employees and was substantially completed as of December 31, 2022, with minimal expenses to be completedincurred in 2023.

12


Table of Contents

On February 3, 2023, the Company committed to a plan to restructure its workforce to increase productivity and enhance profitability. The reduction in force reduced the Company’s headcount by the end71 employees, or approximately 7% of 2022 and will result inall employees. The Company incurred a total charge of approximately

 $3.0 million,$1,817 in the first quarter of which approximately $2.0 million is attributable to2023 in connection with the retention benefits associated with approximately 25 employees and the remaining $1.0 
million is related to the other exit activities, including but not limited to contract termination, decommission and transportationrestructuring, primarily consisting of certain fixed assets. As employees are required to provide future services, employee retention and other benefit-related costs are expensed over the service period.
severance payments.

As a result of the restructuring activities, the Company incurred

a pre-tax charge
of $264$1,908 and $927$264 during the three months ended March 31, 20222023 and 2021,2022, respectively. These charges were included in selling, general and administrative expenses in the consolidated statements of operations. The liability related to the restructuring activities was $132$1,087 and $3,168$1,192 as of March 31, 20222023 and December 31, 2021,2022, respectively, 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. 
liabilities.

 

 

Employee

 

 

Other

 

 

Total

 

Liability balance as of December 31, 2022

 

$

1,010

 

 

$

182

 

 

$

1,192

 

Expenses

 

 

1,817

 

 

 

91

 

 

 

1,908

 

Payments

 

 

(1,740

)

 

 

(273

)

 

 

(2,013

)

Liability balance as of March 31, 2023

 

$

1,087

 

 

$

-

 

 

$

1,087

 

 

 

 

 

 

 

 

 

 

 

 

 

Employee

 

 

Other

 

 

Total

 

Liability balance as of December 31, 2021

 

$

2,517

 

 

$

651

 

 

$

3,168

 

Expenses

 

 

115

 

 

 

149

 

 

 

264

 

Payments

 

 

(2,517

)

 

 

(783

)

 

 

(3,300

)

Liability balance as of March 31, 2022

 

$

115

 

 

$

17

 

 

$

132

 

   
Employee
   
Other
   
Total
 
Liability balance as of December 31, 2021  $2,517   $651 
$
 
3,168
 
Expenses   115    149   
264
 
Payments   (2,517   (783  
(3,300
)

               
Liability balance as of March 31, 2022  $115   $17  
$
132
 
               

13. Long-Term Debt Obligations

Long-term debt obligations consisted of the following:

 

 

March 31,

 

 

December 31,

 

 

 

2023

 

 

2022

 

Line of credit

 

$

-

 

 

$

-

 

Term loan

 

 

70,313

 

 

 

71,250

 

Less debt discount and debt issuance cost

 

 

(444

)

 

 

(481

)

Term loan, net of debt discount and debt issuance cost

 

$

69,869

 

 

$

70,769

 

   
March 31,
2022
   
December 31,
2021
 
Line of credit  $0     $0   
           
Term loan   73,593    74,062 
Less debt discount and debt issuance cost   (598   (637
           
Term loan, net of debt discount, debt issuance cost  $72,995   $73,425 
           
13

2021 Credit Agreement

In August 2021, the Company, as borrower, its subsidiaries, as guarantors, and Silicon Valley Bank (“SVB”), and the several other lenders thereto (collectively, the “Lenders”) entered into a credit agreement, as amended (the “2021 Credit Agreement”), providing for a term loan facility not to exceed $75,000$75,000 (the “Term Loan Facility”) and a revolving credit facility not to exceed $125,000$125,000 (the “Revolving Facility”). The Company’s obligations to the Lenders are secured by substantially all of the Company’s assets, including intellectual property. Capitalized terms used herein and not otherwise defined are defined as set forth in the 2021 Credit Agreement.

Advances

made under the 2021 Credit Agreement may be either EurodollarSOFR Loans or ABR Loans, at the Company’s option. For EurodollarSOFR Loans, the interest rate is a per annum interest rate equal to LIBORthe Adjusted Term SOFR plus an Applicable Margin between 2.00%2.00% to 3.25%3.25% based on the Total Net Leverage Ratio. For ABR Loans, the interest rate is equal to (1) the highest of (a) the Wall Street Journal Prime Rate, (b) the Federal Funds Rate plus 0.50% and (c) the LIBORAdjusted Term SOFR rate plus 1.0%,
plus
(2) an Applicable Margin between 1.00%1.00% to 2.25%2.25% based on the Total Net Leverage Ratio.

The 2021 Credit Agreement requires the Company to make consecutive quarterly installment payments equal to the following: (a) from September 30, 2021 through and including June 30, 2022, $469;$469; (b) from September 30, 2022 through and including June 30, 2023, $938;$938; (c) from September 30, 2023 through and including June 30, 2025, $1,406$1,406 and (d) from September 30, 2025 and the last

13


Table of Contents

day of each quarter thereafter until August 6, 2026 (the “Term Loan Maturity Date”), $1,875.$1,875. The remaining principal balance of $50,625 is also due on the Term Loan Maturity Date. The Company may prepay the Term Loan Facility, provided that any Term Loans prepaid prior to August 6, 2022 must be accompanied by a prepayment premium equal to 1.00% of the aggregate amount of Term Loans prepaid.Facility. Once repaid, amounts borrowed under the Term Loan Facility may not

be re-borrowed.

The Company must pay in arrears, on the first day of each quarter prior to August 6, 2026 (the “Revolving Termination Date”) and on the Revolving Termination Date, a fee for the

Company’s non-use of
available funds (the “Commitment Fee”). The Commitment Fee rate is between 0.25%0.25% to 0.45%0.45% based on the Total Net Leverage Ratio. The Company may elect to reduce or terminate the Revolving Facility in its entirety at any time by repaying all outstanding principal and unpaid accrued interest and, with respect to any such reduction or termination of the Revolving Commitments made prior to August 6, 2022, 1.00% of the aggregate amount of the Revolving Commitments so reduced or terminated.
 
interest.

Under the 2021 Credit Agreement, the Company is required to comply with certain financial covenants including the Consolidated Fixed Charge Coverage Ratio and Consolidated Total Net Leverage Ratio, tested quarterly. In addition, the Company is also required to make representations and warranties and comply with certain

non-financial
covenants that are customary in loan agreements of this type, including restrictions on the payment of dividends, repurchase of stock, incurrence of indebtedness, dispositions and acquisitions.
The Company had outstanding borrowings of $73,593 and $74,062 under the Term Loan Facility and $0 under the Revolving Facility with $125,000 available for future revolving borrowings as of March 31, 2022 and December 31, 2021, respectively.

The Company recorded additional debt issuance costs and related fees of $604$604 in connection with entering into 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 entering into the Revolving Facility, the Company recorded debt issuance costs and related fees of $1,223, which are recorded$1,223 as other assets. Both of these costs are being amortized to interest expense through the maturity date of the facilities.

As of March 31, 2023 and December 31, 2022, the Company had outstanding borrowings of $70,313 and $71,250 under the Term Loan Facility, respectively, and $0 under the Revolving Facility with $125,000 available for future revolving borrowings.

Future payments of the 2021 Credit Agreement, as of March 31, 2022,2023, are as follows for the calendar years ending December 31:

 

 

 

 

2023

 

 

3,750

 

2024

 

 

5,625

 

2025

 

 

6,563

 

2026

 

 

54,375

 

Total

 

$

70,313

 

2022  $2,343 
2023   4,687 
2024   5,625 
2025   6,563 
2026   54,375 
      
Total  $73,593 
      
2019 Credit Agreement
In March 2019, the Company, its subsidiaries and SVB, and the several other lenders thereto entered into a credit agreement, as amended (the “2019 Credit Agreement”), providing for a term loan facility of $40,000 and a revolving credit facility of up to $60,000. Both facilities were set to mature in 2024. The interest rate for the term loan facility was 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 for advances under the revolving facility was a floating per annum interest rate equal to the greater of the Wall Street Journal Prime Rate and 5.50%. If the Company elected to prepay the loan or terminate the facilities, the Company was required to pay a certain percentage of the outstanding principal as a prepayment fee. A final payment fee (the “Final Payment”) of 6.5% multiplied by the original aggregate principal amount of term loan facility was due upon the earlier to occur of the maturity date of the term loan or prepayment of all outstanding principal
.

14

In August 2021, upon entering into the 2021 Credit Agreement, the Company paid an aggregate amount of $70,559 due under the 2019 Credit Agreement, including unpaid principal, accrued interest, the Final Payment and a prepayment fee, with proceeds from the 2021 Credit Agreement, and the 2019 Credit Agreement was terminated. Upon termination of the 2019 Credit Agreement, the Company recognized $1,883 as loss on the extinguishment of the loan for the year ended December 31, 2021.

14. Stockholders’ Equity

Common Stock

As of March 31, 2022,

t
he2023, the issued shares of Class A common stock include 728,548 treasury shares that were reacquired in connection with the redemption of redeemable shares in March 2019.

As of March 31, 20222023 and December 31, 2021,2022, the Company reserved the following shares of Class A common stock for future issuance:

 

 

March 31,

 

 

December 31,

 

 

 

2023

 

 

2022

 

Shares reserved for issuance for outstanding options

 

 

9,456,596

 

 

 

5,931,742

 

Shares reserved for issuance for outstanding restricted stock units

 

 

4,111,720

 

 

 

1,381,500

 

Shares reserved for issuance for future grants

 

 

4,831,088

 

 

 

11,394,962

 

Total shares of authorized common stock reserved for future issuance

 

 

18,399,404

 

 

 

18,708,204

 

   
March 31
2022
   
December 31,
2021
 
Shares reserved for issuance for outstanding options   7,924,792    6,596,969 
Shares reserved for issuance for outstanding restricted stock units   1,496,853    764,871 
Shares reserved for issuance for future grants   3,373,334    5,644,691 
           
Total shares of authorized common stock reserved for future issuance   12,794,979    13,006,531 
           

 

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

14


Table of Contents

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.
A

At the adoption of the 2018 Plan, a total of

9,198,996
shares of Class A common stock have beenwas 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). There has been no change to the total authorized shares since the adoption ofIn June 2022, the 2018 Plan.
Plan was amended to increase the number of shares of Class A common stock reserved for issuance by 7,826,970 shares.

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 Class A common stock that are tendered to the Company by a participant to exercise an award will not be available for future awards.

Stock-Based Compensation Expense

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

15

Stock-based compensation expense was $1,303$1,914 and $698$1,303 for the three months ended March 31, 20222023 and 2021,2022, respectively. The total amount of stock-based compensation expense was included within selling, general and administrative expenses on the consolidated statements of operations.

Restricted Stock Units (RSUs)

The Company granted 931,4313,192,372 and 284,708931,431 time-based restricted stock units to its employees, executives and the Board of Directors in the three months ended March 31, 20222023 and 2021,2022, respectively. Each restricted stock unit represents the contingent right to receive one share of the Company’s Class A common stock. A majority of the restricted stock units will vest in four equal annual 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

 

 

Weighted Average

 

 

of Shares

 

 

Grant Date

 

 

 

 

 

Fair Value

 

Unvested at December 31, 2022

 

 

1,381,500

 

 

$

7.62

 

Granted

 

 

3,192,372

 

 

 

2.47

 

Vested

 

 

(416,753

)

 

 

7.71

 

Canceled/Forfeited

 

 

(45,399

)

 

 

7.25

 

Unvested at March 31, 2023

 

 

4,111,720

 

 

$

3.61

 

   
Number of
Shares
   
Weighted
Average
Grant Date
Fair Value
 
Unvested at December 31, 2021   764,871   $7.52 
Granted   931,431    7.59 
Vested   (179,714   7.81 
Canceled/Forfeited   (19,735   6.83 
           
Unvested at March 31, 2022   1,496,853   $    7.54 
           

As of March 31, 2022,2023, the total unrecognized compensation cost related to unvested restricted stock units expected to vest was $7,892$10,551 and the weighted average remaining recognition period for unvested awards was 3.193.00 years.

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Table of Contents

Stock Option Valuation

Options

The stock options granted during the three months ended March 31, 2023 and 2022 were 3,554,528and 2021 were 1,418,224 and 1,037,099,, 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:

 

 

March 31,

 

 

March 31,

 

 

 

2023

 

 

2022

 

Risk-free interest rate

 

 

3.99

%

 

 

1.92

%

Expected term (in years)

 

 

6.24

 

 

 

6.25

 

Expected volatility

 

 

51.00

%

 

 

50.66

%

Expected dividend yield

 

 

0.0

%

 

 

0.0

%

Exercise price

 

$

2.51

 

 

$

8.03

 

Underlying stock price

 

$

2.47

 

 

$

7.87

 

         
   
Three Months Ended

March 31,
 
   
2022
  
2021
 
Risk-free interest rate   1.92  0.82
Expected term (in years)   6.25   6.21 
Expected volatility   50.66  39.30
Expected dividend yield   0.0  0.0
Exercise price  $8.03  $13.54 
Underlying stock price  $    7.87  $    13.54 

16

These assumptions resulted in an estimated weighted-average grant-date fair value per share of stock options granted during the three months ended March 31, 2023 and 2022 of $1.32and 2021 of $3.94 and $5.31,$3.94, respectively.

Stock Option Activity

The following table summarizes the Company’s stock option activity since December 31, 2021: 2022:

 

 

 

 

 

 

 

 

Weighted

 

 

 

 

 

 

 

 

 

 

 

 

Average

 

 

 

 

 

 

 

 

 

Weighted

 

 

Remaining

 

 

 

 

 

 

 

 

 

Average

 

 

Contractual

 

 

Aggregate

 

 

 

Number of

 

 

Exercise

 

 

Term

 

 

Intrinsic

 

 

 

Shares

 

 

Price

 

 

(in years)

 

 

Value

 

Outstanding as of December 31, 2022

 

 

5,931,042

 

 

$

5.91

 

 

 

6.14

 

 

$

2,245

 

Granted

 

 

3,554,528

 

 

 

2.51

 

 

 

 

 

 

 

Exercised

 

 

-

 

 

 

-

 

 

 

 

 

 

-

 

Canceled / forfeited

 

 

(28,974

)

 

 

11.12

 

 

 

 

 

 

 

Outstanding as of March 31, 2023

 

 

9,456,596

 

 

 

4.62

 

 

 

7.39

 

 

 

1,475

 

Options exercisable as of March 31, 2023

 

 

3,695,292

 

 

 

4.61

 

 

 

4.58

 

 

 

1,475

 

Options vested or expected to vest as of March 31, 2023

 

 

8,153,239

 

 

$

4.67

 

 

 

7.06

 

 

$

1,475

 

   
Number of
Shares
   
Weighted
Average
Exercise
Price
   
Weighted
Average
Remaining
Contractual
Term

(in years)
   
Aggregate
Intrinsic
Value
 
Outstanding as of December 31, 2021   6,596,969   $4.10    5.20   $38,524 
Granted   1,418,224    8.03           
Exercised   (86,121   3.38         441 
Canceled / forfeited   (4,280   2.69           
                     
Outstanding as of March 31, 2022   7,924,792    4.82    5.83    29,053 
                     
Options exercisable as of March 31, 2022   4,600,567    2.52    3.57    25,113 
                     
Options vested or expected to vest as of March 31, 2022   7,215,073   $4.44    5.50   $28,567 
                     

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 three months ended March 31, 2023 and 2022 was $2,653and 2021 was $1,612 and $143,$1,612, respectively.

As of March 31, 2022,2023, the total unrecognized stock compensation expense related to unvested stock options expected to vest was $7,579$8,575 and was expected to be recognized over a weighted-average period of 3.292.95 years.

16. Net IncomeEarnings (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 equity awards using the treasury stock method which includes consideration of unrecognized compensation expenses as additional proceeds.

 

The Company’s potentially dilutive securities include restricted stock units and stock options to purchase shares of Class A reconciliation ofcommon stock. As the numerator and denomina

to
r usedCompany had a net loss in the calculationperiods presented, the potentially dilutive securities have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted-average number of common shares outstanding used to calculate both basic and diluted net incomeloss per share attributable to the Class A common stockholders is as follows.
   
Three Months Ended
March 31,
 
   
2022
   
2021
 
Numerator:          
Net Income  $87   $9,943 
Denominator:          
Weighted average common shares outstanding —basic

   128,788,721    127,870,065 
Dilutive effect of restricted stock units   264,075    527,658 
Dilutive effect of options   3,752,358    5,054,227 
           
Weighted-average common shares outstanding—diluted   132,805,154    133,451,950 
Earnings per share—basic  $0.00   $0.08 
           
Earnings per share—diluted  $0.00   $0.07 
           

17

the same for these periods. For the three months ended March 31, 2023 and 2022, the Company excluded 800,395and
20
21,
4,016,433 potential shares of Class A common stock, respectively, presented based on the diluted effects of options and restricted stock units outstanding stock-based awards of 155,207 and 1,202,193 were excludedat each period end, from the computation of diluted EPS calculation as they were anti-dilutive.net loss per share attributable to the common stockholders for these periods.

16


Table of Contents

17. Leases

As of December 31, 2021 and March 31, 2022, the

The Company’s contracts that contained a lease consistedleases consist primarily of real estate, equipment and vehicle leases.

The Company leases real estate for office, lab, warehouse and production space under noncancelable leases that expire at various dates through 2035, subject to the Company’s options to terminate or renew certain leases for an additional five to ten years.

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 will 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 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.
The Company records rent expense for its operating leases on a straight-line basis from the lease commencement date until the end of the 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 area maintenance and maintenance programs for leased vehicles. Variable lease payments are based on the occurrence or usage; therefore, they are not included as part of the initial
right-of-use
assets and liabilities calculation.

On January 1, 2013, the Company entered into finance 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 directors, former directors and / or stockholders of the Company. In August 2021, the Company purchased the building under the lease with 275 Dan Road SPE, LLC (the “275 Dan Road Building”) for $6,013 and the lease was terminated. Other than the lease with 275 Dan Road SPE, LLC which was terminated in August 2021, as discussed below, the remaining three leases were set to terminate on December 31, 2022, and each contained a renewal option for a five-year period with a rental rate at the greater of (i) rent for the last year of the prior term, or (ii) the then fair market value. The Company exercised the option to extend the leases for an additional five years in November 2021. TheseIt remeasured the lease assets and liabilities based on its best estimate of the market rental rate in the renewal period and reassessed the classification for these leases according to ASC 842-10-25-1 Lease Classification. As a result, these leases were reclassified from finance leases to operating leases upon the Company’s reassessment of the lease classification according to ASC

842-10-25-1
Lease Classification.
. The related finance lease assets and liabilities were reclassified to operating
lease right-of-use assets
and operating lease obligations on the consolidated balance sheet as of December 31, 2021.
As of In December 31, 2020,2022, the Company owedand the landlord finalized the market rental rate in the renewal period for these properties, resulting in an aggregate of $10,336 ofadditional $8,060 to be recorded as variable lease expenses over the renewal period.

The Company owes some accrued but unpaid lease obligations under the aforementioned leases. 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 inunder the 2019 Credit Agreement. These accrued but unpaid lease obligations as well as the accrued interest on these obligations were subordinated to the 2019 Credit Agreement. With the termination of the 2019 Credit Agreement and the execution of the 2021 Credit Agreement (see Note “13. Long-Term Debt Obligations”) in August 2021, these obligations are no longer subordinated to the Company’s existing loans.

18

In
August 2021, the Company purchased the building (the “275 Dan Road Building”) under the lease with 275 Dan Road SPE, LLC for $6,013 and the lease was terminated. The Company recorded an asset of $4,943 to buildings within fixed asset, net in accordance with ASC
842-20-40-2
Purchase of the Underlying Asset
to account for the purchase of the leased asset. In connection with the purchase of the 275 Dan Road Building in August 2021, the Company paid 50%50% of the accrued but unpaid lease obligations associated with this building and the accrued interest thereof. The remaining balance is beingfor this building was paid off in five quarterly installments ending on January 3, 2023. The interest on the balance of the accrued but unpaid lease obligations associated with the 275 Dan Road Building was reduced to an annual simple rate of 4.5%.

The accrued but unpaid lease obligations as well as the related interest accruals are shown below.

 

 

March 31,

 

 

December 31,

 

 

 

2023

 

 

2022

 

Principal portion of rent in arrears

 

 

5,273

 

 

 

5,779

 

Total accrued but unpaid lease obligations

 

 

5,273

 

 

 

5,779

 

 

 

 

 

 

 

Accrued interest on accrued but unpaid lease obligations

 

 

1,960

 

 

 

1,956

 

   
March 31
   
December 31,
 
   
2022
   
2021
 
Principal portion of rent in arrears   7,246    7,246 
Unpaid operating and common area maintenance costs   52    558 
           
Total accrued but unpaid lease obligations   7,298    7,804 
Accrued interest on accrued but unpaid lease obligations   1,956    1,938 
The

Before being paid off in January 2023, the principal portion of rent in arrears related to the 275 Dan Road Building as well as the interest accrual were included in accrued expenses and other current liabilities on the consolidated balance sheet as of December 31, 2022. For the other three buildings, the principal portion of rent in arrears was included in the short-term portion of operating lease obligations other thanon the consolidated balance related tosheets as of March 31, 2023 and December 31, 2022. The accrued interest on the 275 Dan Road Building thataccrued but unpaid lease obligations was included in accrued expenses and other current liabilities on the consolidated balance sheets as of March 31, 20222023 and December 31, 2021. The unpaid operating and common area maintenance costs, and the accrued interest on the accrued but unpaid lease obligations were included in accrued expenses and other current liabilities on the consolidated balance sheets as of March 31, 2022 and December 31, 20212022.

.
 

The components of lease cost were as follows:

 

 

Classification

 

Three Months Ended
March 31,

 

 

 

 

 

2023

 

 

2022

 

Finance lease

 

 

 

 

 

 

 

 

Amortization of right-of-use assets

 

COGS and SG&A

 

$

-

 

 

$

107

 

Interest on lease liabilities

 

Interest Expense

 

 

-

 

 

 

5

 

Total Finance lease cost

 

 

 

 

-

 

 

 

112

 

Operating lease cost

 

COGS, R&D, SG&A

 

 

2,291

 

 

 

2,434

 

Short-term lease cost

 

COGS, R&D, SG&A

 

 

758

 

 

 

669

 

Variable lease cost

 

COGS, R&D, SG&A

 

 

1,794

 

 

 

918

 

Total lease cost

 

 

 

$

4,843

 

 

$

4,133

 

17


Table of Contents

      
Three Months Ended

March 31,
 
  
Classification
  
 
2022
 
   2021 
    
 
 
   
 
 
 
Finance lease
      
Amortization of
right-of-use
assets
  COGS and SG&A  $107   $299 
Interest on lease liabilities  Interest Expense   5    349 
              
Total Finance lease cost      112    648 
Operating lease cost  COGS, R&D, SG&A   2,434    1,280 
Short-term lease cost  COGS, R&D, SG&A   669    715 
Variable lease cost  COGS, R&D, SG&A   918    1,363 
              
Total lease cost     $4,133   $4,006 
              

Supplemental balance sheet information related to finance leases was as follows:

 

 

March 31, 2023

 

 

December 31, 2022

 

Property and equipment, gross

 

$

1,174

 

 

$

1,174

 

Accumulated depreciation

 

 

(1,174

)

 

 

(1,174

)

Property and equipment, net

 

$

-

 

 

$

-

 

 

 

 

 

 

 

Finance lease obligations

 

$

-

 

 

$

-

 

   
March 31, 2022
   
December 31,
2021
 
Property and equipment, gross  $1,174   $1,174 
Accumulated depreciation   (1,067   (961
           
Property and equipment, net
  $107   $213 
           
Finance lease obligations

  
$

101   
$

200

 
           

19

Supplemental cash flow information related to leases was as follows:

 

 

Three Months Ended
March 31,

 

 

 

2023

 

 

2022

 

Cash paid for amounts included in the measurement of lease liabilities:

 

 

 

 

 

 

Operating cash flows for operating leases

 

 

2,468

 

 

 

2,337

 

Operating cash flows for finance leases

 

 

-

 

 

 

5

 

Financing cash flows for finance leases

 

 

-

 

 

 

99

 

 

 

 

 

 

 

 

Right-of-use assets obtained in exchange for lease obligations

 

 

 

 

 

 

Operating leases

 

 

1,586

 

 

 

171

 

Finance leases

 

 

-

 

 

 

-

 

 

 

March 31, 2023

 

 

December 31, 2022

 

Weighted-average remaining lease term

 

 

 

 

 

 

Finance leases

 

 

-

 

 

 

-

 

Operating leases

 

 

7.25

 

 

 

7.54

 

 

 

 

 

 

 

 

 

 

March 31, 2023

 

 

December 31, 2022

 

Weighted-average discount rate

 

 

 

 

 

 

Finance leases

 

 

-

 

 

 

-

 

Operating leases

 

 

4.65

%

 

 

4.61

%

                                        
   
Three Months Ended

March 31,
 
   
2022
   
2021
 
Cash paid for amounts included in the measurement of lease liabilities:
    
Operating cash flows for operating leases  $2,337   $1,362 
Operating cash flows for finance leases  $5   $523 
Financing cash flows for finance leases  $99   $675 
Right-of-use
assets obtained in exchange for lease obligations
          
Operating leases  $171   $310 
Finance leases  $—     $—   
   
March 31,
2022
  
December 31,
2021
 
Weighted-average remaining lease term
   
Finance leases   0.21    0.45 
Operating leases   8.04    8.22 
   
March 31,
2022
  
December 31,
2021
 
Weighted-average discount rate
   
Finance leases   11.30  11.30
Operating leases   4.53  4.51

As of March 31, 2021,2023, maturities of lease liabilities were as follows:

 

 

Operating leases

 

2023 (remaining 9 months)

 

$

12,157

 

2024

 

 

7,798

 

2025

 

 

7,678

 

2026

 

 

7,542

 

2027

 

 

8,002

 

Thereafter

 

 

18,612

 

Total lease payments

 

 

61,789

 

Less: interest

 

 

(9,304

)

Total lease liabilities

 

$

52,485

 

         
   
Operating leases
   
Finance leases
 
2022  $11,873   $103 
2023   8,104    0   
2024   7,315    0   
2025   7,526    0   
2026   7,435    0   
Thereafter   25,966    0   
           
Total lease payments   68,219    103 
Less: interest   (11,121   (2
           
Total lease liabilities  $    57,098   $    101 
           

18. Commitments and Contingencies

Royalties

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

18


Table of Contents

$1,187 as of March 31, 20222023 and December 31, 2021,2022, respectively, and were classified as part of accrued expenses and other current liabilities on the Company’s consolidated balance sheets. There was 0no royalty expense incurred during the three months ended March 31, 20222023 or 20212022 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 $1,601$1,440 and $1,220$1,601 during the three months ended March 31, 20222023 and 2021,2022, respectively, within selling, general and administrative expenses on the consolidated statements of operations.


20

Legal Matters

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 $150$150 as of March 31, 20222023 and December 31, 2021 in relation to2022, for certain pending lawsuits.

19. Related Party Transactions

Lease obligations to affiliates, including accrued but unpaid lease obligations, and purchase of an asset under a finance lease with an affiliate, and renewal of leases with affiliates are further described in Note “17. Leases”.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 matured with all principal and accrued interest due on the tenth anniversary of the issuance date of each subject loan. Interest on the Employer Loans was at various rates ranging from 2.30
%
-
3.86% per annum, compounded annually. The Employer Loans were secured by shares of the Company’s Class A common stock held by the former executives. With respect to the Liquidity Loans, the Company had no personal recourse against the borrowers beyond the pledged shares. As of December 31, 2020, Liquidity Loans and Option Loans to one former executive were outstanding with an aggregate principal balance of $100 and $334, respectively. During the three months ended March 31, 2021, this former executive paid off the outstanding principal balance of his Employer Loans and the related interest receivable. As a result, the Company recorded $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 year ended December 31, 2021. The $334 of the repaid principal balance of the Option Loans was recorded to equity.
 

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. As net operating loss carryovers become limited or are fully utilized, the Company will accrue current federal and state income tax expense. The Company’s wholly owned Swiss subsidiary, Organogenesis Switzerland GmbH, is subject to taxation in Switzerland and has a transfer pricing arrangement in place with Organogenesis Inc., its U.S. parent and a wholly owned subsidiary of the Company.

parent.

The income tax rate for the three months ended March 31, 20222023 varied from the U.S. statutory rate of 21%21% primarily due to the tax adjustments related to executive compensation, other permanent tax adjustments, and discrete items. The Company has a pre-tax book loss for the three months ended March 31, 2023 and expects to benefit from this loss through the forecasted pre-tax book income for the twelve months ended December 31, 2023. The income tax benefit for the three months ended March 31, 2023 was $1,658, which included a discrete tax expense of $22 related primarily to the interest on certain uncertain tax positions. Income tax expense for the three months ended March 31, 2022 was $45,$45, which include

d
included a discrete tax expense of $10
,
and$10 related primarily to federal and state taxes. Incomethe interest on certain uncertain tax expense for the three months ended March 31, 2021 was 
$200, which included a discrete expense of $10, and related primarily to state and foreign taxes.
positions.

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. In the fourth quarter of 2021, the Company released the valuation allowance recorded against its U.S. deferred tax assets. Upon reviewing the positive evidence of net operating loss utilization, cumulative profits, and forecasted taxable income, the Company believed that it was more likely than not that these United StatesU.S. deferred tax assets willwould be utilized. There are no material deferred tax assets in the other jurisdictions. On a quarterly basis, the Company reassesses the need for a 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 and negative evidence, including net operating loss utilization, cumulative profits, and forecasted taxable income, the Company determined that it is more likely than not the U.S. deferred assets will be realized in full. As such, the Company hasdid not recordedrecord a valuation allowance against its U.S. deferred tax

assets as of March 31, 20222023 and December 31, 2021. 
2022.

21. Subsequent Events

The Company has evaluated subsequent events through May 10, 2022,2023, the date on which these consolidated financial statements were issued and has determined that there wereare no such events to report.

2
1

19


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 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, 2021,2022, filed with the Securities and Exchange Commission, or the SEC, on March 1, 2022, as amended.2023. Please refer to our cautionary 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, 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 with 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 in various treatment settings. We have a comprehensive portfolio of regenerative medicine products, capable of supporting patients from early in the wound healing process through 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 (manufacturing currently suspended pending transition to our Massachusetts baseda new manufacturing facilities)facility or engagement of a third-party manufacturer); PuraPly AM as an antimicrobial barrier for a broad variety of wound types; and the Affinity, Novachor 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 comprehensive 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 broad regenerative medicine capabilities in this attractive, adjacent market.to address chronic and acute surgical wounds and tendon and ligament injuries. Our Surgical & Sports Medicine products include NuShield for surgical applicationapplications in targeted soft tissue repairs; and Affinity, Novachor, PuraPly MZ and PuraPly AM for management of open wounds in the surgical setting. We currently sell these products through independent agencies and our growing direct sales force.

22

Table of Contents

For the three months ended March 31, 2022,2023, we generated $98.1 million of net revenue of $107.6 million and $0.1reported a net loss of $3.0 million of net income compared to $102.6 million of net revenue of $97.1 million and $9.9a net loss of $0.9 million of net income for the three months ended March 31, 2021. While2022. We have incurred significant losses since inception and, while we reported net income for the most recent twothree years, we have incurred significant losses since inception and, 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 March 31, 2022,2023, we had an accumulated deficit of $60.0$48.9 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 Class A common stock. We operate as one segment of regenerative medicine.

COVID-19

pandemic
The emergence of

On April 10, 2023, President Biden signed a joint congressional resolution ending the coronavirus

(COVID-19)
aroundnational emergency related to COVID-19 and the world, and particularly inBiden Administration previously announced it will end the United States, continuespublic health emergency declaration related to present risks toCOVID-19 on May 11, 2023. While the Company. While the
COVID-19
pandemic has not materially adversely affected our financial results and business operations through the first quarter ended March 31, 2022,2023, COVID-19 continues to present risks to the Company, and we are unablecontinue to predictclosely monitor the impact that
COVID-19
will have on our financial position and operating results because of the numerous uncertainties created by the unprecedented nature of the pandemic. We are closely monitoring the evolving impact of the pandemic on all aspects of our business. We are unable to predict the impact that COVID-19 (including the emergence of new variants) will have implemented a numberon our financial position and operating results in the future.

Dermagraft

20


Table of measures designed to protect the health and safety of our employees, support our customers and promote business continuity. We continue 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.
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, at which time we ceased commercial distribution of ReNu and NuCel. 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 we discontinued clinical development of NuCel.
Contents

As part of our long-term plan to consolidate manufacturing operations in Massachusetts,previously disclosed, manufacturing of Dermagraft was suspended in the fourth quarter of 2021 and sales of Dermagraft will bewere suspended in the second quarter of 2022. We currently plan to transition our Dermagraft manufacturing to our Massachusetts-baseda new manufacturing facilities,facility or engage a third-party manufacturer, which we expect will result in substantial long-term cost savings. In the period when Dermagraft is not available, (possibly for a few years), we expect that customers will be willing to substitute Apligraf for Dermagraft and that the suspension of Dermagraft sales will not have a material impact on our net revenue. However, if we do not realize the expected substantial long-term cost savings or if customers are unwilling to substitute Apligraf for Dermagraft during the period in which Dermagraft is unavailable, it could have an adverse effect on our net revenue and results of operations.

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 March 31, 2022,2023, we had approximately 340315 direct sales representatives and approximately 150155 independent agencies.

23

Table of Contents

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.

Cost of goods sold and gross profit

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 increaseschanges in our cost of goods sold correspond with the increaseschanges in sales units drivenand are also affected 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 the anticipated increase in sales volumes.

mix.

Gross profit is calculated as net revenue less cost of goods sold and generally increases as revenue increases. Our gross profit is 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.

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, gain or loss on disposal of long-lived assets, 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 products through the regulatory pathway (e.g., seek BLAbiologics license application approval), add personnel to support product enhancements as well as to bring new products to market, and enhance our manufacturing process and procedures.

21


Table of Contents

Other expense, net

Interest expense

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

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 including projected future taxable income, recent financial results and estimates of future reversals of deferred tax assets and liabilities. 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 aIn consideration of the factors discussed above, in the fourth quarter of 2021, we have determined it was more likely than not that our deferred tax assets would be realized in the future and released the valuation allowance on our net U.S. deferred tax assets as of December 31, 2021, resulting in a benefit of $48.3 million in income taxes. We maintained the same position that our net U.S. deferred tax assets dodid not require a valuation allowance as of March 31, 20222023 and December 31, 2021.

24

Table of Contents
2022.

We account for uncertainty in income taxes recognized in the consolidated financial 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.

Results of Operations

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

   
Three Months Ended

March 31,
 
   
2022
   
2021
 
Net revenue
  $98,117   $102,552 
Cost of goods sold
   25,080    25,495 
  
 
 
   
 
 
 
Gross profit
   73,037    77,057 
Operating expenses:
    
Selling, general and administrative
   63,578    58,232 
Research and development
   8,587    6,209 
  
 
 
   
 
 
 
Total operating expenses
   72,165    64,441 
  
 
 
   
 
 
 
Income from operations
   872    12,616 
  
 
 
   
 
 
 
Other expense, net:
    
Interest expense
   (737   (2,470
Other expense, net
   (3   (3
  
 
 
   
 
 
 
Total other expense, net
   (740   (2,473
  
 
 
   
 
 
 
Net income before income taxes
   132    10,143 
Income tax expense
   (45   (200
  
 
 
   
 
 
 
Net income
  $87   $9,943 
  
 
 
   
 
 
 

 

 

Three Months Ended
March 31,

 

 

 

2023

 

 

2022

 

Net revenue

 

$

107,642

 

 

$

97,117

 

Cost of goods sold

 

 

26,607

 

 

 

25,080

 

Gross profit

 

 

81,035

 

 

 

72,037

 

Operating expenses:

 

 

 

 

 

 

Selling, general and administrative

 

 

73,834

 

 

 

63,578

 

Research and development

 

 

11,202

 

 

 

8,587

 

Total operating expenses

 

 

85,036

 

 

 

72,165

 

Loss from operations

 

 

(4,001

)

 

 

(128

)

Other expense, net:

 

 

 

 

 

 

Interest expense

 

 

(649

)

 

 

(737

)

Other income (expense), net

 

 

23

 

 

 

(3

)

Total other expense, net

 

 

(626

)

 

 

(740

)

Net loss before income taxes

 

 

(4,627

)

 

 

(868

)

Income tax benefit (expense)

 

 

1,658

 

 

 

(45

)

Net loss

 

$

(2,969

)

 

$

(913

)

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,(“non-GAAP”), in addition to financial measures in accordance with GAAPgenerally accepted accounting principles in the United States (“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

22


Table of Contents

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.

25

Table of Contents

The following is a reconciliation of GAAP net income to

non-GAAP
EBITDA and
non-GAAP
Adjusted EBITDA for each of the periods presented:

 

 

Three Months Ended
March 31,

 

 

 

2023

 

 

2022

 

 

 

(Unaudited) (in thousands)

 

Net loss

 

$

(2,969

)

 

$

(913

)

Interest expense, net

 

 

649

 

 

 

737

 

Income tax expense (benefit)

 

 

(1,658

)

 

 

45

 

Depreciation

 

 

2,694

 

 

 

1,347

 

Amortization

 

 

1,230

 

 

 

1,221

 

EBITDA

 

 

(54

)

 

 

2,437

 

Stock-based compensation expense

 

 

1,914

 

 

 

1,303

 

Restructuring charge (1)

 

 

1,908

 

 

 

264

 

Settlement fee (2)

 

 

-

 

 

 

1,000

 

Adjusted EBITDA

 

$

3,768

 

 

$

5,004

 

(1)
Amounts reflect employee severance, retention and benefits as well as other exit costs associated with the Company’s restructuring activities. See Note “12. Restructuring” to our consolidated financial statements included in this Quarterly Report on Form 10-Q.
(2)
Amount reflects the fee the Company agreed to pay to a GPO to settle previously disputed GPO fees.
   
Three Months Ended

March 31,
 
   
2022
   
2021
 
Net income
  $87   $9,943 
Interest expense
   737    2,470 
Income tax expense
   45    200 
Depreciation
   1,347    1,010 
Amortization
   1,221    1,243 
  
 
 
   
 
 
 
EBITDA
   3,437    14,866 
  
 
 
   
 
 
 
Stock-based compensation expense
   1,303    698 
Recovery of certain notes receivable from related parties (1)
   —      (179
Change in fair value of Earnout (2)
   —      (296
Restructuring charge (3)
   264    927 
  
 
 
   
 
 
 
Adjusted EBITDA
  $5,004   $16,016 
  
 
 
   
 
 
 
(1)
Amount reflects the collection of certain notes receivable from related parties previously reserved. See Note “19. Related Party Transactions”.
(2)
Amount reflects the change in the fair value of the Earnout liability in connection with the CPN acquisition. See Note “3. Acquisition” and “5. Fair Value Measurement of Financial Assets and Liabilities”.
(3)
Amount reflects employee retention and benefits as well as the facility-related cost related to the Company’s restructuring activities. See Note “12. Restructuring”.

Comparison of the Three Months Ended March 31, 20222023 and 2021

2022

Revenue

   
Three Months Ended
March 31,
   
Change
 
   
2022
   
2021
   
$
   
%
 
        
   
(in thousands, except for percentages)
 
Advanced Wound Care
  $90,950   $90,708   $242    0
Surgical & Sports Medicine
   7,167    11,844    (4,677   (39%) 
  
 
 
   
 
 
   
 
 
   
 
 
 
Net revenue
  $98,117   $102,552   $(4,435   (4%) 
  
 
 
   
 
 
   
 
 
   
 
 
 

 

 

Three Months Ended
March 31,

 

 

Change

 

 

 

2023

 

 

2022

 

 

$

 

 

%

 

 

 

(in thousands, except for percentages)

 

Advanced Wound Care

 

$

100,917

 

 

$

90,090

 

 

$

10,827

 

 

 

12

%

Surgical & Sports Medicine

 

 

6,725

 

 

 

7,027

 

 

 

(302

)

 

 

(4

%)

Net revenue

 

$

107,642

 

 

$

97,117

 

 

$

10,525

 

 

 

11

%

Net revenue from our Advanced Wound Care products in the three months ended March 31, 2022 was $91.0increased by $10.8 million, relatively consistent with the net revenue of $90.7or 12%, to $100.9 million in the three months ended March 31, 2021.

2023 from $90.1 million in the three months ended March 31, 2022. The increase in Advanced Wound Care net revenue was primarily attributable to an increase in sales of certain products to our existing and new customers.

Net revenue from our Surgical & Sports Medicine products decreased by $4.7 million, or 39%,slightly to $7.2$6.7 million in the three months ended March 31, 20222023 from $11.8$7.0 million in the three months ended March 31, 2021.2022. The decrease in Surgical & Sports Medicine net revenue was primarily due to the continued impactattrition within our direct sales force.

23


Table of the suspensionContents

Cost of marketinggoods sold and gross profit

 

 

Three Months Ended
March 31,

 

 

Change

 

 

 

2023

 

 

2022

 

 

$

 

 

%

 

 

 

(in thousands, except for percentages)

 

Cost of goods sold

 

$

26,607

 

 

$

25,080

 

 

$

1,527

 

 

 

6

%

Gross profit

 

$

81,035

 

 

$

72,037

 

 

$

8,998

 

 

 

12

%

Gross profit%

 

 

75

%

 

 

74

%

 

 

 

 

 

 

Cost of our ReNu and NuCel products in connection with the expiration of the FDA’s enforcement grace period on May 31, 2021 and,goods sold increased by $1.5 million, or 6%, to a lesser extent, the impact of the

COVID-19
pandemic on sales of our Affinity product.
Included within net revenue is PuraPly revenue of $53.3$26.6 million and $41.3 million for the three months ended March 31, 2022 and 2021, respectively. The continued increase in PuraPly revenue in the three months ended March 31, 2022 was due to our expanded sales force, expanded sites of care, and increased adoption, by existing and new customers, of our PuraPly line extensions.
26

Cost of goods sold and gross profit
                                                
   
Three Months Ended
March 31,
   
Change
 
   
2022
   
2021
   
$
   
%
 
        
   
(in thousands, except for percentages)
 
Cost of goods sold
  $25,080   $25,495   $(415   (2%) 
  
 
 
   
 
 
   
 
 
   
 
 
 
Gross profit
  $73,037   $77,057   $(4,020   (5%) 
  
 
 
   
 
 
   
 
 
   
 
 
 
Cost of goods sold decreased by $0.4 million, or 2%, to2023 from $25.1 million in the three months ended March 31, 2022 from $25.5 million in the three months ended March 31, 2021.2022. The decreaseincrease in cost of goods sold was primarily due to decreased unit volumesincreased sales volume in Surgical & Sports Medicineour Advanced Wound Care products.

Gross profit decreasedincreased by $4.0$9.0 million, or 5%12%, to $73.0$81.0 million in the three months ended March 31, 20222023 from $77.1$72.0 million in the three months ended March 31, 2021.2022. The decreaseincrease in gross profit resulted primarily from decreasedincreased sales volume in Surgical & Sports Medicineour Advanced Wound Care products as well as increased manufacturing-related costs.

a shift in product mix to our higher gross margin products.

Research and Development Expenses

                                                
   
Three Months Ended
March 31,
   
Change
 
   
2022
   
2021
   
$
   
%
 
        
   
(in thousands, except for percentages)
 
Research and development
  $8,587   $6,209   $2,378    38
  
 
 
   
 
 
   
 
 
   
 
 
 

 

 

Three Months Ended
March 31,

 

 

Change

 

 

 

2023

 

 

2022

 

 

$

 

 

%

 

 

(in thousands, except for percentages)

 

Research and development

 

$

11,202

 

 

$

8,587

 

 

$

2,615

 

 

 

30

%

Research and development expenses increased by $2.4$2.6 million, or 38%30%, to $11.2 million in the three months ended March 31, 2023 from $8.6 million in the three months ended March 31, 2022 from $6.2 million in the three months ended March 31, 2021.2022. The increase in research and development expenses was primarily due to 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 seek regulatory approvals for certain of our products, and increased headcount associated with our existing Advanced Wound Care and Surgical & Sports Medicine products.

Selling, General and Administrative Expenses

              
              
              
              
   
Three Months Ended
March 31,
   
Change
 
   
2022
   
2021
   
$
   
%
 
        
   
(in thousands, except for percentages)
 
Selling, general and administrative
  $63,578   $58,232   $5,346    9
  
 
 
   
 
 
   
 
 
   
 
 
 

 

 

Three Months Ended
March 31,

 

 

Change

 

 

 

2023

 

 

2022

 

 

$

 

 

%

 

 

 

(in thousands, except for percentages)

 

Selling, general and administrative

 

$

73,834

 

 

$

63,578

 

 

$

10,256

 

 

 

16

%

Selling, general and administrative expenses increased by $5.3$10.3 million, or 9%16%, to $73.8 million in the three months ended March 31, 2023 from $63.6 million in the three months ended March 31, 2021 from $58.2 million in the three months ended March 31, 2020.2022. The increase in selling, general and administrative expenses was primarily due to a $4.1$4.2 million increase related to an annual sales meeting that was held in the first quarter of 2023 (and in 2022, the sales meeting was held in the third quarter instead of the first quarter), a $2.2 million increase related to additional headcount, primarily in our direct sales force andprior to the February 2023 reduction in force, a $2.0$1.9 million increase related to increased travelin legal and marketing programs amid

consulting costs associated with the relaxed COVID-19 travel
restrictions. These increases were partially offset byongoing operations of our business and the ERP system implementation, a $0.7$1.7 million decreaseincrease in restructuring costs primarily due to the substantial completionreduction in force in the first quarter of the restructuring activities associated with closing the La Jolla, California office.
27
2023, and a $0.3 million miscellaneous increase.

24


Other Expense, net

                                                
   
Three
Months Ended
March 31,
   
Change
 
   
2022
   
2021
   
$
   
%
 
                 
   
(in thousands, except for percentages)
 
Interest expense, net
  $(737  $(2,470  $1,733    (70%) 
Other expense, net
   (3   (3   —      ** 
  
 
 
   
 
 
   
 
 
   
 
 
 
Total other expense, net
  $(740  $(2,473  $1,733    (70%) 
  
 
 
   
 
 
   
 
 
   
 
 
 
**
not meaningful

 

 

Three Months Ended
March 31,

 

 

Change

 

 

 

2023

 

 

2022

 

 

$

 

 

%

 

 

 

(in thousands, except for percentages)

 

Interest expense, net

 

$

(649

)

 

$

(737

)

 

$

88

 

 

 

(12

%)

Other income (expense), net

 

 

23

 

 

 

(3

)

 

 

26

 

 

**

 

Total other expense, net

 

$

(626

)

 

$

(740

)

 

$

114

 

 

 

(15

%)

** not meaningful

Other expense, net, decreased by $1.7$0.1 million, or 70%15%, to $0.7$0.6 million in the three months ended March 31, 20222023 from $2.5 million in the three months ended March 31, 2021. Interest expense decreased due to the reduced interest rate for borrowings under the 2021 Credit Agreement.

Income Tax Expense
            
            
            
            
   
Three Months Ended
March 31,
   
Change
 
   
2022
   
2021
   
$
   
%
 
                 
   
(in thousands, except for percentages)
 
Income tax expense
  $(45  $(200  $155    (78%) 
  
 
 
   
 
 
   
 
 
   
 
 
 
Income tax expense decreased by $0.2 million, or 78% to $0.0 million in the three months ended March 31, 2022 from $0.2 million in the three months ended March 31, 2021. The decrease in the provision is primarily attributed to the decrease in taxable income from $10.1 million in the three months ended March 31, 2021 to $0.1$0.7 million in the three months ended March 31, 2022. The decrease in taxable income is partially offset byother expense, net was primarily due to the increasedecrease in interest expense resulting from the effective rate from 2.19%lower debt balance under the 2021 Credit Agreement.

Income Tax Expense

 

 

Three Months Ended
March 31,

 

 

Change

 

 

2023

 

 

2022

 

 

$

 

 

%

 

 

(in thousands, except for percentages)

Income tax benefit (expense)

 

$

1,658

 

 

$

(45

)

 

$

1,703

 

 

**

** not meaningful

Income tax benefit (expense) changed to a benefit of $1.7 million in the three months ended March 31, 2021 to 26.65%2023 from an expense of $45 thousand in the three months ended March 31, 20222022. The change in income tax benefit (expense) is due to the release of the valuation allowancea higher pre-tax loss in the three months ended March 31, 2023 and a higher effective rate for the twelve months ended December 31, 2021.

2023 resulting from the larger forecasted tax adjustment primarily related to executive compensation in 2023 as compared to 2022.

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 March 31, 2022,2023, we had an accumulated deficit of $60.0$48.9 million and working capital of $141.1$140.7 million which included $107.9$88.7 million in cash and cash equivalents. We also had $125,000have $125.0 million available for future revolving borrowings under our Revolving Facility (see Note “13. Long-Term Debt Obligations”) to our consolidated financial statements included in this Quarterly Report on Form 10-Q). For the three months ended March 31, 2022,2023, we reported $98.1 million in net revenue $0.1of $107.6 million, ina net incomeloss of $3.0 million and $1.4$5.1 million of cash flowsoutflows from operating activities. We expect that our cash on hand and other components of working capital as of March 31, 2022,2023, availability under the 2021 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 impactaffect our commercial prospects, cash position and access to capital in fiscal 20222023 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.

Our primary uses of cash are working capital requirements, capital expenditure 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 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.

28

25


Cash Flows

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

   
Three Months Ended
March 31,
 
   
2022
   
2021
 
   
(in thousands)
 
Net cash provided by (used in) operating activities
  $1,411   $(1,300
Net cash used in investing activities
   (6,672   (4,957
Net cash used in financing activities
   (765   (591
  
 
 
   
 
 
 
Net change in cash, cash equivalents, and restricted cash
  $(6,026  $(6,848
  
 
 
   
 
 
 

 

 

Three Months Ended
March 31,

 

 

 

2023

 

 

2022

 

 

 

(in thousands)

 

Net cash used in (provided by) operating activities

 

$

(5,077

)

 

$

1,411

 

Net cash used in investing activities

 

 

(7,562

)

 

 

(6,672

)

Net cash used in financing activities

 

 

(1,236

)

 

 

(765

)

Net change in cash, cash equivalents, and restricted cash

 

$

(13,875

)

 

$

(6,026

)

Operating Activities

During the three months ended March 31, 2023, net cash used in operating activities was $5.1 million, resulting from our net loss of $3.0 million and net cash used in connection with changes in our operating assets and liabilities of $11.8 million, partially offset by non-cash charges of $9.7 million. Net cash used in changes in our operating assets and liabilities included an increase in accounts receivable of $3.4 million, an increase in inventory of $2.2 million, an increase in prepaid expenses and other current assets of $4.8 million, a decrease in operating leases liabilities of $2.1 million, and a decrease in accounts payable of $1.4 million, partially offset by an increase in accrued expenses and other liabilities of $2.1 million.

During the three months ended March 31, 2022, net cash provided by operating activities was $1.4 million, resulting from our net income of $0.1 million and

non-cash
charges of $8.2 million, partially offset by our net loss of $0.9 million and cash used in connection with changes in our operating assets and liabilities of $6.9$5.9 million. Net cash used in changes in our operating assets and liabilities included an increase in prepaid expenses and other current assets of $2.2 million, a decrease in operating leases liability of $1.8 million, a decrease in accounts payable of $1.2 million, and a decrease in accrued expenses and other current liabilities of $4.8$3.8 million, all of which were partially offset by a decrease in accounts receivable of $2.9 million.

Investing Activities

During the three months ended March 31, 2021, net2023, we used $7.6 million of cash used in operatinginvesting activities was $1.3 million, resulting from our net cash used in connection with changes in our operating assets and liabilitiesconsisting exclusively of $19.1 million, partially offset by net income of $9.9 million

and non-cash charges
of $7.8 million. Net cash used in changes in our operating assets and liabilities included an increase in accounts receivable of $16.1 million, an increase in inventory of $4.2 million, an increase in prepaid expenses and other current assets of $0.6 million, and a decrease in operating leases and other liabilities of $1.4 million, all of which were partially offset by an increase in accounts payable of $1.8 million, and an increase of accrued expenses and other current liabilities of $1.4 million.
Investing Activities
capital expenditures.

During the three months ended March 31, 2022, we used $6.7 million of cash in investing activities consisting exclusively of capital expenditures.

Financing Activities

During the three months ended March 31, 2021, we2023, net cash used $5.0 millionin financing activities was $1.2 million. This consisted of cash in investing activities consisting exclusivelythe payment of capital expenditures.

Financing Activities
term loan and the stock awards activities.

During the three months ended March 31, 2022, net cash used byin financing activities was $0.8 million. This consisted primarily of the payment of $0.6 million for term loan and finance lease obligations, of $0.6 million, and net payment of $0.2 million in connection with the stock awards activities.

During the three months ended March 31, 2021, net cash used by financing activities was $0.6 million. This consisted primarily of the payment of finance lease obligations of $0.7 million, and the payment of $0.5 million related to the NuTech Medical deferred acquisition consideration, partially offset by net proceeds of $0.6 million in connection with the stock award activities.

Indebtedness

2021 Credit Agreement

In August 2021, we and our subsidiaries entered into a credit agreement with SVB and several other lenders, which we refer to as the 2021 Credit Agreement. The 2021 Credit Agreement, as amended, provides for a term loan facility not to exceed $75,000$75.0 million (the “Term Loan Facility”) and a revolving credit facility not to exceed $125,000$125.0 million (the “Revolving Facility”).

29

Advances made under the 2021 Credit Agreement may be either EurodollarSOFR Loans or ABR Loans, at our option. For EurodollarSOFR Loans, the interest rate is a per annum interest rate equal to LIBOR the Adjusted Term SOFRplus an Applicable Margin between 2.00% to 3.25% based on the Total Net Leverage Ratio. For ABR Loans, the interest rate is equal to (1) the highest of (a) the Wall Street Journal Prime Rate, (b) the Federal Funds Rate plus 0.50% and (c) the LIBORAdjusted Term SOFR rate plus 1.0%,

plus
(2) an Applicable Margin between 1.00% to 2.25% based on the Total Net Leverage Ratio.

The 2021 Credit Agreement requires us to make consecutive quarterly installment payments of principal in an amount equal to between 0.625% to 2.50% of the original principal amount of the Term Loans startingfollowing: (a) from September 30, 2021 through and including June 30, 2022, $0.5 million; (b) from September 30, 2022 through and including June 30, 2023, $0.9 million; (c) from September 30, 2023 through and including June 30, 2025, $1.4 million and (d) from September 30, 2025

26


Table of Contents

and the last day of each quarter thereafter until August 6, 2026 (the “Term Loan Maturity Date”)., $1.9 million. The remaining principal balance of $50.6 million is also due on the Term Loan Maturity Date. We may prepay the Term Loan Facility, provided that any Term Loans prepaid prior to August 6, 2022, must be accompanied by a prepayment premium equal to 1.00% of the aggregate amount of Term Loans prepaid.Facility. Once repaid, amounts borrowed under the Term Loan Facility may not

be re-borrowed.

We must pay a quarterly fee in arrears, (the “Commitment Fee”), foron the

Company’s non-use first day of
available funds through each quarter prior to August 6, 2026 (the “Revolving Termination Date”) and on the Revolving Termination Date, a fee for our non-use of available funds (the “Commitment Fee”). The Commitment Fee rate is between 0.25% to 0.45% based on the Total Net Leverage Ratio. We may elect to reduce or terminate the Revolving Facility in its entirety at any time by repaying all outstanding principal and unpaid accrued interest and, with respect to any such reduction or termination of the Revolving Commitments made prior to August 6, 2022, 1.00% of the aggregate amount of the Revolving Commitments so reduced or terminated.
interest.

Under the 2021 Credit Agreement, we are required to comply with certain financial covenants including the Consolidated Fixed Charge Coverage Ratio and Consolidated Total Net Leverage Ratio, tested quarterly. In addition, we are also required to make representations and warranties and comply with certain

non-financial
covenants that are customary in loan agreements of this type, including restrictions on the payment of dividends, repurchase of stock, incurrence of indebtedness, dispositions and acquisitions.

As of March 31, 2022,2023, we were in compliance with the covenants under the 2021 Credit Agreement. We had outstanding borrowings of $70.3 million under the Revolving Facility andour Term Loan Facility of the 2021 Credit Agreement of $0.0and no borrowings outstanding under our Revolving Facility with $125 million and $73.6 million,available for future revolving borrowings, respectively.

2019 Credit Agreement
In March 2019, we, our subsidiaries and SVB, and the several other lenders thereto entered into a credit agreement, as amended (the “2019 Credit Agreement”), providing for a term loan facility of $40,000 and a revolving credit facility of up to $60,000. Both facilities were set to mature in 2024. The interest rate for the term loan facility was 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 for advances under the revolving facility was a floating per annum interest rate equal to the greater of the Wall Street Journal Prime Rate and 5.50%. If we elected to prepay the loan or terminate the facilities, we were required to pay a certain percentage of the outstanding principal as a prepayment fee. A final payment fee (the “Final Payment”) of 6.5% multiplied by the original aggregate principal amount of term loan facility was due upon the earlier to occur, the maturity date of the term loan or prepayment of all outstanding principal.
In August 2021, upon entering into the 2021 Credit Agreement, we paid an aggregate amount of $70.6 million due under the 2019 Credit Agreement, including unpaid principal, accrued interest, the Final Payment and a prepayment fee, with proceeds from the 2021 Credit Agreement, and the 2019 Credit Agreement was terminated. Upon termination of the 2019 Credit Agreement, the Company recognized $1.9 million as loss on the extinguishment of the loan for the year ended December 31, 2021.

Critical Accounting Policies and Significant Judgments and Estimates

Our unaudited consolidated financial statements have been prepared in accordance with GAAP. The preparation of our unaudited 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 unaudited consolidated 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 unaudited 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, 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, 20212022, for information about these accounting policies as well as a description of our other significant accounting policies.

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.
30

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 Quarterly Report on

Form 10-Q.

Item 3. Quantitative and Qualitative Disclosures aboutAbout Market Risk.

We are exposed

During the three months ended March 31, 2023, there were no material changes to various market risks, including fluctuations in interest rates and variability in currency exchange rates. We have established policies, procedures and internal processes governing our management of market risk disclosures as set forth in Part II, Item 7A “Quantitative and Qualitative Disclosures About Market Risk” in our Annual Report on Form 10-K for the usefiscal year ended December 31, 2022.

27


Table of financial instruments to manage our exposure to such risk.
Contents

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 March 31, 2022.2023. The term “disclosure controls and procedures,” as defined in

Rules 13a-15(e) and
15d-15(e) under
the Securities Exchange Act of 1934, as amended (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”).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.

Based on their evaluation, our management, including our principal executive officer and principal financial officer, concluded that, as of March 31, 2023, our disclosure controls and procedures were ineffective because, as disclosed in the Company’s Annual Report for the fiscal year ended December 31, 2022, our management team identified the following material weakness in our internal control over financial reporting: we did not design and maintain effective controls (i) to properly identify and assess significant non-routine transactions and (ii) over information technology general controls and proper segregation of duties to support the proper initiation and recording of transactions and the resulting impact on business process controls and applications that rely on such data.

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.

Management assessed the effectiveness of the Company’s internal control over financial reporting based on the criteria established in the SEC guidance on conducting such assessments as of the end of the period covered by this report. Management conducted the assessment based on certain criteria established in Internal Control— Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission in 2013. As a result of this assessment, management concluded that, as of March 31, 2022,2023, our internal control over financial reporting was not effective based on those criteria.

As disclosed in the Company’s Annual Report for the fiscal year ended December 31, 2021, our management team identified the following material weakness in our internal control over financial reporting: 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, 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.
31

Although management has made significantnotable progress in remediating this material weakness, management concluded that the material weakness described above continued to exist as of March 31, 2022. Specifically, when validating the operating effectiveness of certain controls over financial reporting to gain assurance that such controls are present and functioning as designed, management identified deficiencies that indicate a lack of sustainability and inconsistent application of certain policies, procedures, and controls, including the proper segregation of duties, exacerbated in part by turnover within key positions during the past year.
2023.

Plans for Remediation of Material Weakness

Management has taken actions to remediate the deficiencies in its internal controls over financial reporting and implemented additional processes and controls designed to address the underlying causes associated with the above-mentioned material weakness. Management is committed to finalizing the remediation of the material weakness during 2022.weakness. Management’s internal control remediation efforts include the following:

We are planningIn 2022, we finalized the implementation ofplan to implement a new company-wide enterprise resource planning, or ERP, system to provide additional systematic controls and segregation of duties for our accounting processes. Due, in part, to turnover in key positions and changes in design, our ERP system go-live date has been delayed. We anticipate that the ERP system will gogoing live in 2022.
2023.
In 2022, we determined that our forward-facing customer sales systems were not catering to our customer needs. We plan to implement a new sales force software system in 2023.
We have continued to train and cross train our employees on their internal control responsibilities and how to best support the Companyother control owners if personnel turnover issues within their departments occur. We have also supplemented our internal resources with third-party resources, where necessary.
We have continued to engageinstituted a new Director of Internal Audit overseeing an outside firm that will continue to assist management with performing control operating effectiveness testing throughout the year.
We regularly reported the results of control testing to the key stakeholders across theour organization, including theour audit committee, on testing progress and defined corrective actions, and we monitored and reported on the results of control remediation. Through these actions, weWe have continued to strengthenstrengthened our internal policies, processes, and reviews.
reviews through these actions.
We implemented a new control to ensure that significant transactions are identified and effectively communicated so that they are properly and timely reported.

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We have continued working on documenting and remediating weaknesses and structuring the Company’s processes to meet SOX 404(b) requirements.

As management continues to evaluate and work to improve our internal control over financial reporting, management may determine it is necessary to take additional measures to address the material weakness.weaknesses. However, we believe the above actions will be effective in remediating the material weaknesses and we will continue to devote significant time and attention to these remediation efforts. Until the controls have been operating for a sufficient period of time and management has concluded, through testing, that these controls are executed consistently and operating effectively, the material weaknessweaknesses described above will continue to exist.

Changes in Internal Control Over Financial Reporting

There have been no changes in our internal control over financial reporting that occurred during the quarter ended March 31, 20222023 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 and our remediation efforts continue, 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.

PART II – OTHER INFORMATION

On December 10, 2021, a class action complaint captioned Somogyi v. Organogenesis Holdings Inc., et al. was filed on behalf of a putative class of all purchasers of our securities against us and our Chief Executive Officer and Chief Financial Officer in the United States District Court for the Eastern District of New York. The court appointed Donald Martin as lead plaintiff. Mr. Martin filed an amended complaint on October 24, 2022 that brings claims on behalf of a purported class of all purchasers of our securities from August 10, 2020 through August 9, 2022 and alleges violations of federal securities law in connection with alleged false and misleading statements with respect to, among other matters, revenue, sales growth and ability to compete in connection with our Affinity and PuraPly XT products. The complaint alleges violations of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder, and seeks unquantified damages as well as attorneys’ fees, expert fees and other costs. The action is in the early stages of litigation. We believe the claims are without merit and intend to vigorously contest them. On March 13, 2023, we filed our motion to dismiss the litigation for failure to state a claim upon which relief can be granted.

We are not a party to any other 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.

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Item 1A. Risk Factors

Investing in our Class A common stock involves a high degree of risk. Our Annual Report on Form

10-K
for the year ended December 31, 2021, as amended,2022, includes a detailed discussion of our risk factors under the heading “Part I, Item 1A—Risk Factors.” ThereExcept as set forth below, there have been no material changes from such risk factors during the quarter ended March 31, 2022.2023. You should consider carefully the risk factors discussed in our Annual Report on Form
10-K
for the year ended December 31, 2021,2022, 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, 20212022, 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 Class A 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.

Uncertainty and adverse changes in the general economic conditions, including recent turmoil in the global banking system, may negatively affect our business, financial condition, stock price and results of operations.

Our results of operations could be adversely affected by general conditions in the global economy and in the global financial markets. For example, the global financial crisis of 2007-2008 caused extreme volatility and disruptions in the capital and credit markets. If general economic conditions in the United States decline, or if consumers fear that economic conditions will decline, sales of our products may decline. Adverse changes may occur as a result of adverse economic conditions, fluctuating oil prices, supply chain problems, inflation, political instability, declining consumer confidence, a continuation or worsening of the COVID-19

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pandemic or another pandemic, unemployment, fluctuations in stock markets, contraction of credit availability, or other factors affecting economic conditions generally. These changes may negatively affect the sales of our existing or development of future products, increase the cost, and decrease the availability of financing, or increase costs associated with producing and distributing our products and potential product candidates.

Moreover, there has been recent turmoil in the global banking system. On March 10, 2023, Silicon Valley Bank (“SVB”), one of our lenders at which we maintained deposit and money market accounts, was closed, followed on March 11, 2023 and May 1, 2023, by Signature Bank and First Republic Bank, respectively, and the FDIC was appointed as receiver for those banks. There have been reports of instability at other banks across the globe including Credit Suisse, which was acquired by UBS. Despite the steps taken to date by U.S. agencies to protect depositors and our current belief that we do not have exposure to loss as a result of SVB’s receivership, the follow-on effects of the events surrounding the SVB, Signature Bank and First Republic Bank failures and pressure on other banks are unknown and could include failures of other financial institutions or significant disruptions to our operations, financial position, and reputation. A severe or prolonged economic downturn, such as the global financial crisis of 2007-2008, could result in a variety of risks to our business, including a decrease in the demand for our products and in our ability to raise additional capital when needed on acceptable terms, if at all. A weak or declining economy also could strain our suppliers, possibly resulting in supply disruption, or cause our customers to delay making payments for our products. We cannot anticipate all the ways in which the foregoing, and the current economic climate and financial market conditions generally, could adversely impact our business. Furthermore, our stock price may decline due in part to the volatility of the stock market and any general economic downturn.

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

None.

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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

Certificate of Amendment of Certificate of Incorporation of Organogenesis Holdings Inc. (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K (File No. 001-37906) filed with the SEC on June 27, 2022)

3.3

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)

31.1†

10.1†

Second Amendment to Credit Agreement dated as of March 31, 2023 by and among Organogenesis Holdings Inc., as borrower, the several banks and other financial institutions or entities party hereto and Silicon Valley Bank, a division of First-Citizens Bank & Trust Company (successor by purchase to the Federal Deposit Insurance Corporation as receiver for Silicon Valley Bridge Bank, N.A. (as successor to Silicon Valley Bank)), as the Administrative Agent

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

104†

Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

104 Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101)
Filed herewith
††
Furnished herewith
*
Management contract or compensatory plan or arrangement
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† Filed herewith

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SIGNATURES

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

Dated: May 10, 20222023

Organogenesis Holdings Inc.

(Registrant)

/s/ David Francisco

David Francisco

Chief Financial Officer

(Principal Financial and Accounting Officer)

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