0000950170-23-020572.txt : 20230510 0000950170-23-020572.hdr.sgml : 20230510 20230510162304 ACCESSION NUMBER: 0000950170-23-020572 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20230510 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20230510 DATE AS OF CHANGE: 20230510 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Organogenesis Holdings Inc. CENTRAL INDEX KEY: 0001661181 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-37906 FILM NUMBER: 23906823 BUSINESS ADDRESS: STREET 1: 85 DAN ROAD CITY: CANTON STATE: MA ZIP: 02021 BUSINESS PHONE: 781-575-0775 MAIL ADDRESS: STREET 1: 85 DAN ROAD CITY: CANTON STATE: MA ZIP: 02021 FORMER COMPANY: FORMER CONFORMED NAME: Avista Healthcare Public Acquisition Corp. DATE OF NAME CHANGE: 20151215 8-K 1 orgo-20230510.htm 8-K 8-K
0001661181False00016611812023-05-102023-05-10

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of Earliest Event Reported): May 10, 2023

ORGANOGENESIS HOLDINGS INC.

(Exact Name of Registrant as specified in its charter)

Delaware

001-37906

98-1329150

(State or Other Jurisdiction

of Incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

85 Dan Road

Canton, MA

02021

(Address of principal executive offices)

(Zip Code)

(781) 575-0775

(Registrant’s telephone number, including area code)

Not Applicable

(Registrant’s name or former address, if change since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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 is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

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 pursuant to Section 13(a) of the Exchange Act. ☐

 

Item 2.02 Results of Operations and Financial Condition.

On May 10, 2023, the Company announced via press release its results for the fiscal first quarter ended March 31, 2023. A copy of the Company’s press release is hereby furnished to the Commission and incorporated herein by reference as Exhibit 99.1.

The information in the press release attached as Exhibit 99.1 is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit

No.

Description

99.1

 

Press Release dated May 10, 2023

104

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

 

 

SIGNATURE

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

Organogenesis Holdings Inc.

By:

/s/ Lori Freedman

Name:

Lori Freedman

Title:

Vice President and General Counsel

 

Date: May 10, 2023

 

 EX-99 2 orgo-ex99_1.htm EX-99.1 EX-99

Exhibit 99.1

 

img36819578_0.jpg

 

FOR IMMEDIATE RELEASE

 

Organogenesis Holdings Inc. Reports First Quarter 2023 Financial Results

 

CANTON, Mass., (May 10, 2023) -- Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture, and commercialization of product solutions for the Advanced Wound Care and Surgical & Sports Medicine markets, today reported financial results for the first quarter ended March 31, 2023.

 

First Quarter 2023 Financial Results Summary:

 

•
Net revenue of $107.6 million for the first quarter of 2023, an increase of $10.5 million compared to net revenue of $97.1 million for the first quarter of 2022. Net revenue for the first quarter of 2023 consists of:
o
Net revenue from Advanced Wound Care products of $100.9 million, an increase of 12% from the first quarter of 2022.
o
Net revenue from Surgical & Sports Medicine products of $6.7 million, a decrease of 4% from the first quarter of 2022.
•
Net loss of $3.0 million for the first quarter of 2023, compared to a net loss of $0.9 million for the first quarter of 2022, an increase of $2.1 million.
•
Adjusted net loss1 of $0.7 million for the first quarter of 2023, compared to an adjusted net income of $1.0 million for the first quarter of 2022, a decrease of $1.6 million.
•
Adjusted EBITDA of $3.8 million for the first quarter of 2023, compared to Adjusted EBITDA of $5.0 million for the first quarter of 2022, a decrease of $1.2 million.

 

“First quarter sales came in above the high-end of the guidance range we provided on our fourth quarter earnings call,” said Gary S. Gillheeney, Sr., President, Chief Executive Officer and Chair of the Board of Organogenesis. “Sales of Advanced Wound Care products drove the majority of the upside in the quarter, exceeding the high-end of our expectations in both the hospital outpatient and physician office settings. As expected, we leveraged our diversified portfolio and leadership position in Wound Care Centers and physician offices across the U.S. to deliver strong growth in Q1.

Mr. Gillheeney, Sr. continued: “We are proud of the team’s execution in Q1 and believe our ability to deliver results above the high-end of our guidance range represents another clear illustration that we have the right strategy to maximize our competitive position in the Advanced Wound Care market. We have increased our financial guidance as a result of the stronger-than-expected first quarter results and look forward to continued progress in 2023. We will continue to be a leader in the Advanced Wound Care space while improving our competitive positions in the Surgical & Sports Medicine and burn markets as we deliver on our mission to provide integrated healing solutions that substantially improve patient outcomes and lower the overall cost of care. We remain committed to educating the public on the benefits of the use of skin substitutes and improving access to clinically efficacious treatment options."

 

1Defined as GAAP net income (loss) adjusted to exclude the effect of amortization, restructuring charges, GPO settlement fee and the resulting income taxes on these items.

 

First Quarter 2023 Financial Results:



 

 

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 for the first quarter of 2023 was $107.6 million, compared to $97.1 million for the first quarter of 2022, an increase of $10.5 million, or 11%. The increase in net revenue was driven by an increase of $10.8 million, or 12% in Advanced Wound Care products partially offset by a decrease of $0.3 million, or 4% in net revenue of Surgical & Sports Medicine products.

 

Gross profit for the first quarter of 2023 was $81.0 million, or 75% of net revenue, compared to $72.0 million, or 74% of net revenue for the first quarter of 2022, an increase of $9.0 million, or 12%.

 

Operating expenses for the first quarter of 2023 were $85.0 million compared to $72.2 million for the first quarter of 2022, an increase of $12.9 million, or 18%. R&D expense was $11.2 million for the first quarter of 2023, compared to $8.6 million in the first quarter of 2022, an increase of $2.6 million, or 30%. Selling, general and administrative expenses were $73.8 million for the first quarter of 2023, compared to $63.6 million in the first quarter of 2022, an increase of $10.3 million, or 16%.

 

Operating loss for the first quarter of 2023 was $4.0 million, compared to an operating loss of $0.1 million for the first quarter of 2022, a decrease of $3.9 million.

 

Total other expense, net, for the first quarter of 2023 was $0.6 million, compared to $0.7 million for the first quarter of 2022, a decrease of $0.1 million.

 

Net loss for the first quarter of 2023 was $3.0 million, or $(0.02) per share, compared to a net loss of $0.9 million, or $(0.01) per share, for the first quarter of 2022, an increase of $2.1 million, or $(0.01) per share.

 

Adjusted net loss of $0.7 million for the first quarter of 2023, compared to adjusted net income of $1.0 million for the first quarter of 2022, a decrease of $1.6 million.

 

Adjusted EBITDA was $3.8 million for the first quarter of 2023, compared to $5.0 million for the first quarter of 2022, a decrease of $1.2 million.

 

As of March 31, 2023, the Company had $89.4 million in cash, cash equivalents and restricted cash and $69.9 million in debt obligations, compared to $103.3 million in cash, cash equivalents and restricted cash and $70.8 million in debt obligations as of December 31, 2022.

 

 

 

 

Fiscal Year 2023 Guidance:

 

For the year ending December 31, 2023, the Company expects:

 

•
Net revenue between $454 million and $466 million, representing an increase of approximately 1% to 3% year-over-year, as compared to net revenue of $450.9 million for the year ended December 31, 2022.
o
The 2023 net revenue guidance range assumes:
▪
Net revenue from Advanced Wound Care products between $424 million and $432 million, an increase of 0% to 2% year-over-year as compared to net revenue of $422.2 million for the year ended December 31, 2022.
▪
Net revenue from Surgical & Sports Medicine products between $30 million and $34 million, an increase of approximately 5% to 19% year-over-year as compared to net revenue of $28.7 million for the year ended December 31, 2022.
•
Net income between $3 million and $11 million and adjusted net income between $8 million and $16 million.
•
EBITDA between $28 million and $39 million and Adjusted EBITDA between $38 million and $49 million.

 

 

First Quarter Earnings Conference Call:

 

Financial results for the first fiscal quarter of 2023 will be reported after the market closes on Wednesday, May 10th. Management will host a conference call at 5:00 p.m. Eastern Time on May 10th to discuss the results of the quarter, and provide a corporate update with a question and answer session. Those who would like to participate may access the live webcast here, or access the teleconference here. A live webcast of the call will also be provided on the investor relations section of the Company's website at investors.organogenesis.com.

For those unable to participate, the webcast will be archived at investors.organogenesis.com for approximately one year.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ORGANOGENESIS HOLDINGS INC.

UNAUDITED CONSOLIDATED BALANCE SHEETS

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

 

 

 

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

 

 

 

 

ORGANOGENESIS HOLDINGS INC. UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS

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

 

 

 

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

 

 

 

 

 

ORGANOGENESIS HOLDINGS INC. UNAUDITED CONSOLIDATED STATEMENT OF CASH FLOWS

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

 

 

 

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

 

 

 

 

 

 

Non-GAAP Financial Measures

Our management uses financial measures that are not in accordance with generally accepted accounting principles in the United States, or GAAP, in addition to financial measures in accordance with GAAP to evaluate our operating results. These non-GAAP financial measures should be considered supplemental to, and not a substitute for, our reported financial results prepared in accordance with GAAP. Our management uses Adjusted EBITDA and adjusted net income to evaluate our operating performance and trends and make planning decisions. Our management believes Adjusted EBITDA and adjusted net income help 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 and adjusted net income provide useful information to investors and others in understanding and evaluating our operating results, enhancing the overall understanding of our past performance and prospects, and allowing for greater transparency with respect to key financial metrics used by our management in its financial and operational decision-making.

The following table presents a reconciliation of GAAP net income to non-GAAP EBITDA and non-GAAP Adjusted EBITDA, for the period 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.
(2)
Amounts reflect the fee the Company paid to a GPO to settle previously disputed GPO fees.

 

 

 

The following table presents a reconciliation of GAAP net loss to non-GAAP adjusted net income (loss), for the periods presented:

 

 

Three Months Ended
March 31,

 

 

 

2023

 

 

2022

 

 

 

(Unaudited) (in thousands)

 

Net loss

 

$

(2,969

)

 

$

(913

)

Amortization

 

 

1,230

 

 

 

1,221

 

Restructuring charge (1)

 

 

1,908

 

 

 

264

 

Settlement fee (2)

 

 

-

 

 

 

1,000

 

Tax on above

 

 

(847

)

 

 

(621

)

Adjusted net income (loss)

 

$

(678

)

 

$

951

 
(1)
Amounts reflect employee severance, retention and benefits as well as other exit costs associated with the Company’s restructuring activities.
(2)
Amounts reflect the fee the Company paid to a GPO to settle previously disputed GPO fees.

 

The following table presents a reconciliation of projected GAAP net income to projected non-GAAP EBITDA and projected non-GAAP Adjusted EBITDA included in our guidance for the year ending December 31, 2023:

 

 

 

Year Ending December 31,

 

 

 

2023L

 

 

2023H

 

Net income

 

$

3,200

 

 

$

10,900

 

Interest expense

 

 

3,300

 

 

 

3,300

 

Income tax expense

 

 

5,100

 

 

 

8,100

 

Depreciation

 

 

11,500

 

 

 

11,500

 

Amortization

 

 

4,900

 

 

 

4,900

 

EBITDA

 

$

28,000

 

 

$

38,700

 

Stock-based compensation expense

 

 

7,900

 

 

 

7,900

 

Restructuring charge

 

 

2,200

 

 

 

2,200

 

Adjusted EBITDA

 

$

38,100

 

 

$

48,800

 

The following table presents a reconciliation of projected GAAP net income to projected non-GAAP adjusted net income included in our guidance for the year ending December 31, 2023:

 

 

 

Year Ending December 31,

 

 

 

2023L

 

 

2023H

 

Net income

 

$

3,200

 

 

$

10,900

 

Amortization

 

 

4,900

 

 

 

4,900

 

Restructuring charge

 

 

2,200

 

 

 

2,200

 

Tax on above

 

 

(1,900

)

 

 

(1,900

)

Adjusted net income

 

$

8,400

 

 

$

16,100

 

 

 

 

Forward-Looking Statements

 

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to expectations or forecasts of future events. Forward-looking statements may be identified by the use of words such as “forecast,” “intend,” “seek,” “target,” “anticipate,” “believe,” “expect,” “estimate,” “plan,” “outlook,” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Such forward-looking statements include statements relating to the Company’s expected revenue, adjusted net revenue, net income, adjusted net income, EBITDA, and Adjusted EBITDA for fiscal 2023 and the breakdown of expected revenue in both its Advanced Wound Care and Surgical & Sports Medicine categories as well as the estimated revenue contribution of its PuraPly products. Forward-looking statements with respect to the operations of the Company, strategies, prospects, and other aspects of the business of the Company are based on current expectations that are subject to known and unknown risks and uncertainties, which could cause actual results or outcomes to differ materially from expectations expressed or implied by such forward-looking statements. These factors include, but are not limited to: (1) the impact of any changes to the reimbursement levels for the Company’s products; (2) the Company faces significant and continuing competition, which could adversely affect its business, results of operations and financial condition; (3) rapid technological change could cause the Company’s products to become obsolete and if the Company does not enhance its product offerings through its research and development efforts, it may be unable to effectively compete; (4) to be commercially successful, the Company must convince physicians that its products are safe and effective alternatives to existing treatments and that its products should be used in their procedures; (5) the Company may owe rebates to the federal government prospectively on certain of its products if more than a certain percentage of the product is not administered to a patient and is discarded (wasted) by providers; (6) the Company’s ability to raise funds to expand its business; (7) the Company has incurred losses in prior years and may incur losses in the future; (8) changes in applicable laws or regulations; (9) the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors; (10) the Company’s ability to maintain production of Affinity in sufficient quantities to meet demand; (11) any resurgence of the COVID-19 pandemic and its impact, if any, on the Company’s fiscal condition and results of operations; (12) the impact of the suspension of commercialization of: (a) ReNu and NuCel in connection with the expiration of the FDA’s enforcement grace period for HCT/Ps on May 31, 2021 and (b) Dermagraft in the second quarter of 2022 pending transition of manufacturing to a new manufacturing facility or a third-party manufacturer; and (13) other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission, including Item 1A (Risk Factors) of the Company’s Form 10-K for the year ended December 31, 2022 and its subsequently filed periodic reports. You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Although it may voluntarily do so from time to time, the Company undertakes no commitment to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities laws.

 

 

 

 

 

 

 

 

 

About Organogenesis Holdings Inc.

Organogenesis Holdings Inc. is a leading regenerative medicine company offering a portfolio of bioactive and acellular biomaterials products in advanced wound care and surgical biologics, including orthopedics and spine. Organogenesis’s comprehensive portfolio is designed to treat a variety of patients with repair and regenerative needs. For more information, visit www.organogenesis.com.

 

Investor Inquiries:
Westwicke Partners
Mike Piccinino, CFA
OrganoIR@westwicke.com
443-213-0500

 

Press and Media Inquiries:
Organogenesis

Lori Freedman

LFreedman@organo.com

 

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Document and Entity Information
May 10, 2023
Cover [Abstract]  
Security Exchange Name NASDAQ
Amendment Flag false
Entity Central Index Key 0001661181
Document Type 8-K
Document Period End Date May 10, 2023
Entity Registrant Name ORGANOGENESIS HOLDINGS INC.
Entity Incorporation State Country Code DE
Entity File Number 001-37906
Entity Tax Identification Number 98-1329150
Entity Address, Address Line One 85 Dan Road
Entity Address, City or Town Canton
Entity Address, State or Province MA
Entity Address, Postal Zip Code 02021
City Area Code (781)
Local Phone Number 575-0775
Written Communications false
Soliciting Material false
Pre Commencement Tender Offer false
Pre Commencement Issuer Tender Offer false
Security 12b Title Class A Common Stock, $0.0001 par value
Trading Symbol ORGO
Entity Emerging Growth Company false
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