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): March 16, 2021

ORGANOGENESIS HOLDINGS INC.

(Exact Name of Registrant as specified in its charter)

(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:

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

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.  ☐

On March 16, 2021, Organogenesis Holdings Inc. (the “Company”) announced via press release its results for the fiscal fourth quarter and year ended December 31, 2020. A copy of the Company’s press release is hereby furnished to the Commission and incorporated herein by reference as Exhibit 99.1.

(d) Exhibits

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.

Date: March 16, 2021

Exhibit 99.1

FOR IMMEDIATE RELEASE

Organogenesis Holdings Inc. Reports Fourth Quarter and Fiscal Year 2020 Financial Results;

Introduces Fiscal Year 2021 Guidance

CANTON, Mass. (March 16, 2021) – 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 three and twelve months ended December 31, 2020 and introduced financial guidance expectations for fiscal year ended December 31, 2021.

Fourth Quarter 2020 Financial Results Summary:

Fiscal Year 2020 Financial Summary:

Fourth Quarter 2020 and Recent Highlights:

“We delivered fourth quarter revenue growth of 43% year-over-year, which was well ahead of our guidance,” said Gary S. Gillheeney, Sr., President and Chief Executive Officer of Organogenesis. “Our Q4 results reflect a continuation of the key drivers of our growth strategy including: the investments we have made to expand our sales force in recent years, the benefits of our comprehensive, and differentiated, portfolio of products that address patients’ needs to treat wounds across all stages and our commercial strategy focused on leveraging multiple channels, new product introductions, and brand loyalty. Strong execution of our strategy drove not only impressive revenue growth, but also, significant improvement in our profitability as evidenced by the 20% operating margins, positive GAAP net income and generating $25 million in adjusted EBITDA this quarter.”

Mr. Gillheeney, Sr. continued: “Despite the challenging operating environment caused by the COVID-19 pandemic, we believe the fundamentals of our business and strategy remain strong and that we are well positioned to deliver strong operating and financial performance in 2021. Our guidance reflects our expectations to grow our revenue 15% to 20% year-over-year and to generate positive GAAP net income and Adjusted EBITDA for the full year 2021 period. We remain confident in our ability to execute our long-term strategic plan of driving strong commercial execution, continued development of our new product pipeline, and improvement of our profitability profile. As always, we are committed to delivering on our mission to provide integrated healing solutions that substantially improve medical outcomes while lowering the overall cost of care.”

Fourth Quarter 2020 Results:

The following table represents net revenue by product grouping for the three months ended December 31, 2020 and December 31, 2019, respectively:

Net revenue for the fourth quarter of 2020 was $106.8 million, compared to $74.6 million for the fourth quarter of 2019, an increase of $32.2 million, or 43%. The increase in net revenue was driven by a $30.2 million increase, or 48%, in net revenue of Advanced Wound Care products and a $1.9 million increase, or 17%, in net revenue of Surgical & Sports Medicine products, compared to the fourth quarter of 2019. The increase in Advanced Wound Care net revenue was primarily attributable to the expanded sales force, increased sales to existing and new customers, and increased adoption of our amniotic product portfolio, including our Affinity product. The increase in Surgical & Sports Medicine net revenue was primarily attributable to the expanded sales force and penetration of existing and new customer accounts, partially offset by postponement or cancellation of medical procedures as a result of COVID-19. Net revenue from the sale of PuraPly products for the fourth quarter of 2020 was $45.3 million, compared to $39.9 million for the fourth quarter of 2019, an increase of $5.4 million, or 13%. Net revenue from the sale of PuraPly products represented approximately 42% of net revenue in the fourth quarter of 2020, as compared to 53% of net revenue in the fourth quarter of 2019.

Gross profit for the fourth quarter of 2020 was $81.3 million, or 76% of net revenue, compared to $54.3 million, or 73% of net revenue, for the fourth quarter of 2019, an increase of $27.0 million, or 50%. The increase in gross profit resulted primarily from increased sales volume due to the strength in our Advanced Wound Care and Surgical & Sports Medicine products as well as a shift in product mix to our higher gross margin products.

Operating expenses for the fourth quarter of 2020 were $59.5 million, compared to $56.0 million for the fourth quarter of 2019, an increase of $3.5 million, or 6%. R&D expense was $6.3 million for the fourth quarter of 2020, compared to $3.6 million in the fourth quarter of 2019, an increase of $2.7 million, or 73%. The increase was primarily due to an increase in process development costs associated with a new contract manufacturer, increased headcount associated with our existing Advanced Wound Care and Surgical & Sports Medicine products, an increase in product costs associated with our pipeline products not yet commercialized, and an increase in the clinical study and related costs necessary to seek regulatory approvals for certain of our products. Selling, general and administrative expenses were $53.2 million, compared to $52.4 million in the fourth quarter of 2019, an increase of $0.8 million, or 2%. The increase in selling, general and administrative expenses was primarily due to additional headcount, primarily in our direct sales force, increased sales commissions due to increased sales, and increased other selling expenses, including credit card processing fees and royalties. These increases were partially offset by decreased expenses related to travel and marketing programs amid travel restrictions in place due to the COVID-19 pandemic.

Operating income for the fourth quarter of 2020 was $21.8 million, compared to an operating loss of $1.8 million for the fourth quarter of 2019, an increase of $23.5 million, primarily due to higher revenue and gross profit compared to the prior year period.

Total other expenses, net, for the fourth quarter of 2020 were $2.9 million, compared to $2.6 million for the fourth quarter of 2019, an increase of $0.3 million, or 11%. The increase was primarily due to higher interest expense resulting from the increased borrowings under the 2019 Credit Agreement.

Net income for the fourth quarter of 2020 was $18.5 million, or $0.16 per share, compared to a net loss of $4.4 million, or $0.04 per share, for the fourth quarter of 2019, an increase of $22.9 million, or $0.20 per share.

Adjusted EBITDA of $24.9 million for the fourth quarter of 2020, compared to Adjusted EBITDA of $0.8 million for the fourth quarter of 2019, an increase of $24.1 million.

As of December 30, 2020, the Company had $84.8 million in cash and restricted cash and $84.8 million in debt obligations, of which $15.1 million were capital lease obligations, compared to $60.4 million in cash and restricted cash and $100.6 million in debt obligations, of which $17.5 million were capital lease obligations as of December 31, 2019.

Fiscal Year 2020 Results:

The following table represents net revenue by product grouping for the twelve months ended December 31, 2020 and December 31, 2019, respectively:

Net revenue for the twelve months ended December 30, 2020 was $338.3 million, compared to $261.0 million for the twelve months of 2019, an increase of $77.3 million, or 30%. The increase in net revenue was driven by a $73.9 million increase, or 33%, in net revenue of Advanced Wound Care products and a $3.4 million increase, or 9%, in net revenue of Surgical & Sports Medicine products compared to the prior year. Net revenue of PuraPly products for the twelve months ended December 30, 2020 were $147.3 million, compared to $126.8 million for the twelve months ended December 30, 2019, an increase of $20.5 million, or 16%. Net revenue of PuraPly products represented approximately 44% of net revenue for the twelve months ended December 30, 2020, compared to 49% for the twelve months ended December 30, 2019.

Net income for the twelve months ended December 30, 2020 was $17.9 million, or $0.16 per share, compared to a net loss of $40.5 million, or $0.44 per share, for the twelve months ended December 30, 2019.

Adjusted EBITDA of $36.9 million for the year ended December 31, 2020, compared to Adjusted EBITDA loss of $18.2 million year ended December 31, 2019.

Fiscal Year 2021 Guidance:

For the twelve months ended December 31, 2021, the Company expects:

Fourth Quarter 2020 Earnings Conference Call:

Financial results for the fourth fiscal quarter of 2020 will be reported after the market closes on Tuesday, March 16.

Management will host a conference call at 5:00 p.m. Eastern Time on March 16 to discuss the results of the quarter and the fiscal year, and provide a corporate update with a question and answer session. Those who would like to participate may dial 866-795-3142 (409-937-8908 for international callers) and provide access code 6766924. 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, a replay of the call will be available for two weeks at 855-859-2056 (404-537-3406 for international callers); access code 6766924. The webcast will be archived at investors.organogenesis.com.

ORGANOGENESIS HOLDINGS INC.

CONSOLIDATED BALANCE SHEETS

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

ORGANOGENESIS HOLDINGS INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

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

ORGANOGENESIS HOLDINGS INC.

CONSOLIDATED STATEMENT OF CASH FLOWS

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

EBITDA and Adjusted EBITDA

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

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

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 for fiscal 2021 and the breakdown of such 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 and the impact to the Company of the loss of preferred “pass through” status for PuraPly AM and PuraPly in 2020; (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’s ability to raise funds to expand its business; (6) the Company has incurred significant losses since inception and may incur losses in the future; (7) changes in applicable laws or regulations; (8) the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors; (9) the Company’s ability to maintain production of Affinity in sufficient quantities to meet demand; (10) the COVID-19 pandemic and its impact, if any, on the Company’s fiscal condition and results of operations; and (11) 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, 2020 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