False000166118100016611812023-03-012023-03-01

 

 

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 1, 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. ☐

 

 

 

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Item 2.02 Results of Operations and Financial Condition.

On March 1, 2023, the Company announced via press release its results for the fiscal fourth quarter and year ended December 31, 2022. 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 March 1, 2023
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

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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: March 1, 2023

 

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Exhibit 99.1

 

 

 

FOR IMMEDIATE RELEASE

 

Organogenesis Holdings Inc. Reports Fourth Quarter 2022and Fiscal Year 2022 Financial Results; Introduces Fiscal Year 2023 Guidance

 

CANTON, Mass., (March 1, 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 fourth quarter and the year ended December 31, 2022.

 

Fourth Quarter 2022 Financial Results Summary:

 

 

Fiscal Year 2022 Financial Results Summary:

 

 

 

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“Fourth quarter sales results came in above the low-end of the guidance range we provided on our third quarter earnings call,” said Gary S. Gillheeney, Sr., President and Chief Executive Officer of Organogenesis. “As expected, we saw a continuation of the challenging operating environment in the physician office setting in Q4, however we delivered double-digit growth in sales of Advanced Wound Care products in the hospital outpatient setting and, excluding ReNu, NuCel and Dermagraft, our team delivered low double-digit growth in the number of accounts served – in both the hospital outpatient and physician office settings.”

 

Mr. Gillheeney, Sr. continued: “Our financial guidance reflects a moderation in net revenue growth driven primarily by the impact of published ASPs in the physician office setting. That said, we expect to deliver solid growth in the hospital outpatient setting, to increase our customer base and to drive customer and clinician adoption deeper into existing accounts again 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 outcomes well over the overall cost of care."

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1Defined as GAAP net income adjusted to exclude the effect of amortization, restructuring charges, the recovery of certain notes receivable from related parties, the change in the fair value of the CPN earnout, loss on extinguishment of debt, write-off of certain assets, facility construction project pause, GPO settlement fee and the resulting income taxes on these items.

 

 

 

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Fourth Quarter 2022 Financial Results:


 

		Three Month Ended December 31,								Change
		2022				2021				$				%
		(in thousands, except for percentages)
Advanced Wound Care		$	108,836			$	120,752			$	(11,916	)			(10	%)
Surgical & Sports Medicine			6,680				7,106				(426	)			(6	%)
Net revenue		$	115,516			$	127,858			$	(12,342	)			(10	%)

 

Net revenue for the fourth quarter of 2022 was $115.5 million, compared to $127.9 million for the fourth quarter of 2021, a decrease of $12.3 million, or 10%. The decrease in net revenue was driven by an decrease of $11.9 million, or 10% in Advanced Wound Care products and a decrease of $0.4 million, or 6% in net revenue of Surgical & Sports Medicine products.

 

Gross profit for the fourth quarter of 2022 was $88.4 million, or 77% of net revenue, compared to $95.3 million or 75% of net revenue for the fourth quarter of 2021, a decrease of $6.9 million, or 7%.

 

Operating expenses for the fourth quarter of 2022 were $79.7 million, compared to $75.5 million for the fourth quarter of 2021, an increase of $4.2 million, or 6%. R&D expense was $11.4 million for the fourth quarter of 2022, compared to $8.3 million in the fourth quarter of 2021, an increase of $3.1 million, or 38%. Selling, general and administrative expenses were $68.3 million, compared to $67.3 million in the fourth quarter of 2021, an increase of $1.0 million, or 2%.

 

Operating income for the fourth quarter of 2022 was $8.7 million, compared to an operating income of $19.8 million for the fourth quarter of 2021, a decrease of $11.0 million.

 

Total other expense, net, for the fourth quarter of 2022 was $0.0 million, compared to $0.9 million for the fourth quarter of 2021, a decrease of $0.9 million.

 

Net income for the fourth quarter of 2022 was $7.5 million, or $0.06 per share, compared to a net income of $51.0 million, or $0.38 per share, for the fourth quarter of 2021, a decrease of $43.5 million, or 0.33 per share.

Adjusted net income of $8.9 million for the fourth quarter of 2022, compared to adjusted net income of $54.0 million for the fourth quarter of 2021, a decrease of $45.1 million, or 83%.

 

Adjusted EBITDA was $14.1 million for the fourth quarter of 2022, compared to $26.3 million for the fourth quarter of 2021, a decrease of $12.3 million, or 47%.

 

As of December 31, 2022, the Company had $103.3 million in cash, cash equivalents and restricted cash and $70.8 million in debt obligations, compared to $114.5 million in cash, cash equivalents and restricted cash and $73.6 million in debt obligations, of which $0.2 million were finance lease obligations as of December 31, 2021.

 

 

 

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Fiscal Year 2022 Results

The following table represents net revenue by product grouping for the year ended December 31, 2022 and December 31, 2021, respectively:

		Year Ended December 31,								Change
		2022				2021				$				%
		(in thousands, except for percentages)
Advanced Wound Care		$	422,231			$	430,237			$	(8,006	)			(2	%)
Surgical & Sports Medicine			28,662				37,122				(8,460	)			(23	%)
Net revenue		$	450,893			$	467,359			$	(16,466	)			(4	%)

 

Net revenue for the year ended December 31, 2022 was $450.9 million, compared to $467.4 million for the year ended December 31, 2021, a decrease of $16.5 million, or 4%. The decrease in net revenue was driven by a decrease of $8.5 million, or 23% in net revenue of Surgical & Sports Medicine products and a decrease of $8.0 million, or 2% in Advanced Wound Care products.

 

Gross profit for the year ended December 31, 2022 is $345.9 million, or 77% of net revenue, compared to $353.2 million, or 76% of net revenue, for the year ended December 31, 2021, a decrease of $7.3 million, or 2%.

 

Operating expenses for the year ended December 31, 2022 were $323.6 million, compared to $280.9 million for the year ended December 31, 2021, an increase of $42.6 million, or 15%. R&D expense was $39.8 million for the year ended December 31, 2022, compared to $30.7 million for year ended December 31, 2021, an increase of $9.0 million, or 29%. Selling, general and administrative expenses were $283.8 million for year ended December 31, 2022, compared to $250.2 million year ended December 31, 2021, an increase of $33.6 million, or 13%.

 

Operating income for the year ended December 31, 2022 was $22.3 million, compared to an operating income of $72.2 million for the year ended December 31, 2021, a decrease of $49.9 million.

 

Total other expense, net, for the year ended December 31, 2022 was $2.0 million, compared to $9.1 million for the year ended December 31, 2021, a decrease of $7.1 million.

 

Net income of $15.5 million for the year ended December 31, 2022 or $0.12 per share, compared to net income of $94.2 million, or $0.70 per share for the year ended December 31, 2021, a decrease of $78.7 million, or $0.59 per share.

 

Adjusted net income for the year ended December 31, 2022 was $26.2 million., compared to $101.3 million for the year ended December 31, 2021, a decrease of $75.0 million, or 74%.

 

Adjusted EBITDA of $49.3 million for the year ended December 31, 2022, compared to an Adjusted EBITDA of $89.1 million for the year ended December 31, 2021, a decrease of $39.9 million, or 45%.

 

 

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Fiscal Year 2023 Guidance:

 

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

 

 

 

Fourth Quarter Earnings Conference Call:

 

Financial results for the fourth fiscal quarter of 2022 will be reported after the market closes on Wednesday, March 1st. Management will host a conference call at 5:00 p.m. Eastern Time on March 1st 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.

 

 

 

 

 

 

 

 

 

 

 

 

 

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ORGANOGENESIS HOLDINGS INC.

UNAUDITED CONSOLIDATED BALANCE SHEETS

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

 

		December 31,
		2022				2021
Assets
Current assets:
Cash and cash equivalents		$	102,478			$	113,929
Restricted cash			812				599
Accounts receivable, net			89,450				82,460
Inventory			24,783				25,022
Prepaid expenses and other current assets			5,086				4,969
Total current assets			222,609				226,979
Property and equipment, net			102,463				79,160
Intangible assets, net			20,789				25,673
Goodwill			28,772				28,772
Operating lease right-of-use assets, net			43,192				49,144
Deferred tax asset, net			30,014				31,994
Other assets			1,520				1,537
Total assets		$	449,359			$	443,259
Liabilities and Stockholders’ Equity
Current liabilities:
Current portion of deferred acquisition consideration		$	-			$	1,436
Current portion of term loan			4,538				2,656
Current portion of finance lease obligations			-				200
Current portion of operating lease obligations			11,708				11,785
Accounts payable			32,330				29,339
Accrued expenses and other current liabilities			26,447				37,289
Total current liabilities			75,023				82,705
Term loan, net of current portion			66,231				70,769
Operating lease obligations, net of current portion			41,314				46,893
Other liabilities			1,122				1,557
Total liabilities			183,690				201,924
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; 131,647,677 and 129,408,740 shares issued; 130,919,129 and 128,680,192 shares outstanding at December 31, 2022 and 2021, respectively.			13				13
Additional paid-in capital			310,957				302,155
Accumulated deficit			(45,301	)			(60,833	)
Total stockholders' equity			265,669				241,335
Total liabilities and stockholders' equity		$	449,359			$	443,259

 

 

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ORGANOGENESIS HOLDINGS INC. UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS

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

 

		Three Months Ended December 31,								Year Ended December 31,
		2022				2021				2022				2021
Net revenue		$	115,516			$	127,858			$	450,893			$	467,359
Cost of goods sold			27,110				32,597				105,019				114,199
Gross profit			88,406				95,261				345,874				353,160
Operating expenses:
Selling, general and administrative			68,293				67,250				283,808				250,200
Research and development			11,395				8,260				39,762				30,742
Total operating expenses			79,688				75,510				323,570				280,942
Income from operations			8,718				19,751				22,304				72,218
Other expense, net:
Interest expense			30				(853	)			(2,009	)			(7,236	)
Loss on the extinguishment of debt			-				-				-				(1,883	)
Other income (expense), net			6				(9	)			(13	)			(13	)
Total other expense, net			36				(862	)			(2,022	)			(9,132	)
Net income before income taxes			8,754				18,889				20,282				63,086
Income tax (expense) benefit			(1,268	)			32,106				(4,750	)			31,116
Net income		$	7,486			$	50,995			$	15,532			$	94,202
Net income, per share:
Basic		$	0.06			$	0.40			$	0.12			$	0.73
Diluted		$	0.06			$	0.38			$	0.12			$	0.70
Weighted-average common shares outstanding
Basic			130,916,950				128,661,435				130,070,231				128,331,022
Diluted			131,857,509				133,348,995				132,383,152				133,662,659

 

 

 

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ORGANOGENESIS HOLDINGS INC. UNAUDITED CONSOLIDATED STATEMENT OF CASH FLOWS

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

 

		Year Ended December 31,
		2022				2021				2020
Cash flows from operating activities:
Net income		$	15,532			$	94,202			$	17,234
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation			5,845				5,781				4,438
Amortization of intangible assets			4,883				4,949				3,745
Amortization of operating lease right-of-use assets			7,303				5,946				-
Non-cash interest expense			434				346				236
Deferred interest expense			501				1,493				2,133
Deferred rent expense			-				-				1,273
Gain on settlement of deferred acquisition consideration			-				-				(2,246	)
Deferred tax expense (benefit)			1,980				(31,976	)			112
Loss on disposal of property and equipment			4,482				1,407				201
Provision recorded for doubtful accounts			1,781				2,999				1,183
Adjustment for excess and obsolete inventories			9,648				12,079				3,050
Stock-based compensation			6,552				3,864				1,661
Loss on extinguishment of debt			-				1,883				-
Change in fair value of Earnout liability			-				(3,985	)			203
Changes in operating assets and liabilities:
Accounts receivable			(8,770	)			(28,654	)			(17,567	)
Inventory			(9,410	)			(9,302	)			(6,700	)
Prepaid expenses and other current assets			(378	)			(34	)			(355	)
Operating leases			(7,006	)			(6,156	)			-
Accounts payable			3,260				3,847				(4,102	)
Accrued expenses and other current liabilities			(11,850	)			9,354				1,443
Other liabilities			72				(6,065	)			(476	)
Net cash provided by operating activities			24,859				61,978				5,466
Cash flows from investing activities:
Purchases of property and equipment			(33,898	)			(31,220	)			(17,678	)
Cash paid for business acquisition			-				-				(5,820	)
Net cash used in investing activities			(33,898	)			(31,220	)			(23,498	)
Cash flows from financing activities:
Line of credit repayments under the 2019 Credit Agreement			-				(10,000	)			(23,484	)
Term loan borrowings (repayments) under the 2019 Credit Agreement			-				(60,000	)			10,000
Proceeds from term loan under the 2021 Credit Agreement, net of debt discount and issuance cost			-				73,174				-
Term loan repayments under the 2021 Credit Agreement			(2,813	)			(938	)			-
Proceeds from equity financing			-				-				64,729
Payment of equity issuance costs			-				-				(5,656	)
Principal repayments of finance lease obligations			(200	)			(2,630	)			(2,427	)
Proceeds from the exercise of stock options			2,070				2,198				2,823
Payments of withholding taxes in connection with RSUs vesting			(648	)			(737	)			-
Payments of deferred acquisition consideration			(608	)			(483	)			(3,517	)
Payment to extinguish debt			-				(1,620	)			-
Net cash provided by (used in) financing activities			(2,199	)			(1,036	)			42,468
Change in cash, cash equivalents and restricted cash			(11,238	)			29,722				24,436
Cash, cash equivalents, and restricted cash, beginning of year			114,528				84,806				60,370
Cash, cash equivalents, and restricted cash, end of year		$	103,290			$	114,528			$	84,806
Supplemental disclosure of cash flow information:
Cash paid for interest		$	2,649			$	5,787			$	9,609
Cash paid for income taxes		$	1,201			$	607			$	61
Supplemental disclosure of non-cash investing and financing activities:
Reimbursement of offering expenses included in prepaid expenses and other current assets		$	-			$	-			$	1,009
Fair value of shares issued for business acquisition		$	-			$	-			$	7,986
Deferred acquisition consideration and earnout liability recorded for business acquisition		$	828			$	-			$	5,218
Purchases of property and equipment in accounts payable and accrued expenses		$	1,928			$	3,750			$	2,391
Right-of-use assets obtained through lease obligations		$	1,350			$	53,793			$	-

 

 

 

 

 

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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 each of the periods presented:

		Three Months Ended December 31,								Year Ended December 31,
		2022				2021				2022				2021
Net income		$	7,486			$	50,995			$	15,532			$	94,202
Interest expense			(30	)			853				2,009				7,236
Income tax expense (benefit)			1,268				(32,106	)			4,750				(31,116	)
Depreciation			1,514				1,771				5,845				5,781
Amortization			1,221				1,223				4,883				4,949
EBITDA			11,459				22,736				33,019				81,052
Stock-based compensation expense			1,855				1,083				6,552				3,864
Restructuring charge (1)			750				1,828				2,268				4,704
Recovery of certain notes receivable from related parties (2)			-				-				-				(179	)
Write-off of certain assets (3)			-				-				4,200				1,104
Change in fair value of Earnout (4)			-				-				-				(3,985	)
Loss on extinguishment of debt (5)			-				-				-				1,883
Facility construction project pause (6)			-				-				632				-
Settlement fee (7)			-				700				2,600				700
Adjusted EBITDA		$	14,064			$	26,347			$	49,271			$	89,143

 

 

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

		Three Months Ended December 31,								Year Ended December 31,
		2022				2021				2022				2021
Net income		$	7,486			$	50,995			$	15,532			$	94,202
Amortization			1,221				1,223				4,883				4,949
Restructuring charge (1)			750				1,828				2,268				4,704
Recovery of certain notes receivable from related parties (2)			-				-				-				(179	)
Write-off of certain assets (3)			-				-				4,200				1,104
Change in fair value of Earnout (4)			-				-				-				(3,985	)
Loss on extinguishment of debt (5)			-				-				-				1,883
Facility construction project pause (6)			-				-				632				-
Settlement fee (7)			-				700.0				2,600