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 second quarter ended June 30th, 2023.
Second Quarter 2023 Financial Results
Summary:
- Net revenue of $117.3 million for the
second quarter of 2023, a decrease of $4.1 million compared to net
revenue of $121.4 million for the second quarter of 2022. Net
revenue for the second quarter of 2023 consists of:
- Net revenue from Advanced Wound Care products of $110.1
million, a decrease of 3% from the second quarter of 2022.
- Net revenue from Surgical & Sports Medicine products of
$7.2 million, a decrease of 5% from the second quarter of
2022.
- Net income of $5.3 million for the
second quarter of 2023, compared to a net income of $8.7 million
for the second quarter of 2022, a decrease of $3.4 million.
- Adjusted net income1 of $6.1 million
for the second quarter of 2023, compared to an adjusted net income
of $11.3 million for the second quarter of 2022, a decrease of $5.2
million.
- Adjusted EBITDA of $15.4 million for
the second quarter of 2023, compared to Adjusted EBITDA of $18.6
million for the second quarter of 2022, a decrease of $3.2
million.
“Second quarter total net revenue came in above the
high-end of the guidance range we provided on our first quarter
earnings call,” said Gary S. Gillheeney, Sr., President, Chief
Executive Officer and Chair of the Board of Organogenesis. “As
expected, we leveraged our diversified portfolio and leadership
position in Wound Care Centers and physician offices across the
U.S. to deliver better-than-expected revenue and profitability
performance in Q2.”
Mr. Gillheeney continued: “The recently published
local coverage determinations (LCDs) from Novitas, First Coast
Services and CGS to limit coverage for treatment of diabetic foot
ulcers (DFU) and venous leg ulcers (VLU) to include only Apligraf
and Dermagraft, presents a significant amount of uncertainty
regarding the revenue outlook for a number of our products in these
regions. Further uncertainty remains as it relates to potential
impact on demand for our products when used for treatment of
non-DFU/VLU wounds. As such, we are withdrawing the fiscal year
2023 guidance, previously provided on May 10, 2023. We believe that
the five commercialized products that were listed as ‘not covered’
were improperly excluded from the list of ‘covered’ products and we
are engaging with all relevant parties in advance of the effective
date of these LCDs on September 17, 2023.”
Second Quarter 2023 Financial
Results:
|
|
Three Months
Ended June 30, |
|
|
Change |
|
|
|
2023 |
|
|
2022 |
|
|
$ |
|
|
% |
|
|
|
(in
thousands, except for percentages) |
|
Advanced Wound Care |
|
$ |
110,075 |
|
|
$ |
113,791 |
|
|
$ |
(3,716 |
) |
|
|
(3 |
%) |
Surgical & Sports Medicine |
|
|
7,241 |
|
|
|
7,610 |
|
|
|
(369 |
) |
|
|
(5 |
%) |
Net revenue |
|
$ |
117,316 |
|
|
$ |
121,401 |
|
|
$ |
(4,085 |
) |
|
|
(3 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenue for the second quarter of 2023 was
$117.3 million, compared to $121.4 million for the second quarter
of 2022, a decrease of $4.1 million, or 3%. The decrease in net
revenue was driven by a decrease of $3.7 million, or 3% in net
revenue for Advanced Wound Care products and a decrease of $0.4
million, or 5%, in net revenue for Surgical & Sports Medicine
products.
Gross profit for the second quarter of 2023 was
$91.0 million, or 78% of net revenue, compared to $94.7 million, or
78% of net revenue for the second quarter of 2022, a decrease of
$3.7 million.
Operating expenses for the second quarter of 2023
were $81.3 million compared to $82.8 million for the second quarter
of 2022, a decrease of $1.6 million. R&D expense was $10.9
million for the second quarter of 2023, compared to $10.2 million
for the second quarter of 2022, an increase of $0.7 million.
Selling, general and administrative expenses were $70.3 million for
the second quarter of 2023, compared to $72.6 million for the
second quarter of 2022, a decrease of $2.3 million.
Operating income for the second quarter of 2023
was $9.7 million, compared to operating income of $11.9 million for
the second quarter of 2022, a decrease of $2.2 million.
Total other expense, net, for the second quarter
of 2023 was $0.6 million, compared to $0.8 million for the second
quarter of 2022, a decrease of $0.2 million.
Net income for the second quarter of 2023 was $5.3
million, or $0.04 per share, compared to net income of $8.7
million, or $0.07 per share, for the second quarter of 2022, a
decrease of $3.4 million, or $0.03 per share.
Adjusted net income of $6.1 million for the second
quarter of 2023, compared to adjusted net income of $11.3 million
for the second quarter of 2022, a decrease of $5.2 million.
Adjusted EBITDA was $15.4 million for the second
quarter of 2023, compared to $18.6 million for the second quarter
of 2022, a decrease of $3.2 million.
As of June 30th, 2023, the Company had $89.5
million in cash, cash equivalents and restricted cash and $69.0
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.
First Half 2023 Results
The following table represents net revenue by
product grouping for the six months ended June 30, 2023 and June
30, 2022, respectively:
|
|
Six Months
Ended June 30, |
|
|
Change |
|
|
|
2023 |
|
|
2022 |
|
|
$ |
|
|
% |
|
|
|
(in
thousands, except for percentages) |
|
Advanced Wound Care |
|
$ |
210,992 |
|
|
$ |
203,881 |
|
|
$ |
7,111 |
|
|
|
3 |
% |
Surgical & Sports Medicine |
|
|
13,966 |
|
|
|
14,637 |
|
|
|
(671 |
) |
|
|
(5 |
%) |
Net revenue |
|
$ |
224,958 |
|
|
$ |
218,518 |
|
|
$ |
6,440 |
|
|
|
3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenue for the six months ended June 30, 2023
was $225.0 million, compared to $218.5 million for the six months
ended June 30, 2022, an increase of $6.4 million, or 3%. The
increase in net revenue was driven by an increase of $7.1 million,
or 3% in net revenue for Advanced Wound Care products. This is
partially offset by a decrease of $0.7 million, or 5% in net
revenue for Surgical & Sports Medicine products.
Gross profit for the six months ended June 30,
2023 was $172.0 million, or 76% of net revenue, compared to $166.8
million, or 76% of net revenue, for the six months ended June 30,
2022, an increase of $5.2 million.
Operating expenses for the six months ended June
30, 2023 were $166.3 million, compared to $155.0 million for the
six months June 30, 2022, an increase of $11.3 million. R&D
expense was $22.1 million for the six months ended June 30, 2023,
compared to $18.8 million in the six months ended June 30, 2022, an
increase of $3.3 million. Selling, general and administrative
expenses were $144.2 million for the six months ended June 30,
2023, compared to $136.2 million in the six months ended June 30,
2022, an increase of $8.0 million.
Operating income for the six months ended June 30,
2023 was $5.7 million, compared to operating income of $11.8
million for the six months ended June 30, 2022, a decrease of $6.1
million.
Total other expenses, net, for the six months
ended June 30, 2023 were $1.2 million, compared to $1.5 million for
the six months ended June 30, 2022, a decrease of $0.3 million.
Net income of $2.3 million for the six months
ended June 30, 2023 or $0.02 per share, compared to net income of
$7.8 million, or $0.06 per share for the six months ended June 30,
2022, a decrease of $5.5 million, or $0.04, per share.
Adjusted net income for the six months ended June
30, 2023 was $5.4 million compared to $12.2 million, for the six
months ended June 30, 2022, a decrease of $6.7 million.
Adjusted EBITDA of $19.2 million for the six
months ended June 30, 2023, compared to an Adjusted EBITDA of $23.6
million, for the six months ended June 30, 2022, a decrease of $4.4
million.
Fiscal Year 2023 Guidance:
The Company is withdrawing its previously
announced fiscal year 2023 guidance, originally issued on May 10,
2023, due to the uncertainty resulting from the potential impact of
the recently published local coverage determinations from Novitas,
First Coast Services and CGS to limit coverage for treatment of
diabetic foot ulcers (DFU) and venous leg ulcers (VLU) to include
only Apligraf and Dermagraft. The Company is currently unable to
predict the impact that the recently published local coverage
determinations will have on its financial position and operating
results.
Second Quarter Earnings Conference
Call:
Financial results for the second fiscal quarter of
2023 will be reported after the market closes on August, 9th.
Management will host a conference call at 5:00 p.m. Eastern Time on
August 9th 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. The live webcast can also be
accessed via the company’s website at investors.organogenesis.com.
The webcast will be archived on the company website for one
year.
|
ORGANOGENESIS HOLDINGS INC. |
UNAUDITED
CONSOLIDATED BALANCE SHEETS |
(amounts in
thousands, except share and per share data) |
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
Assets |
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
88,917 |
|
|
$ |
102,478 |
|
Restricted cash |
|
|
591 |
|
|
|
812 |
|
Accounts receivable, net |
|
|
93,615 |
|
|
|
89,450 |
|
Inventory, net |
|
|
25,364 |
|
|
|
24,783 |
|
Prepaid expenses and other current assets |
|
|
7,948 |
|
|
|
5,086 |
|
Total current assets |
|
|
216,435 |
|
|
|
222,609 |
|
Property and
equipment, net |
|
|
111,825 |
|
|
|
102,463 |
|
Intangible
assets, net |
|
|
18,330 |
|
|
|
20,789 |
|
Goodwill |
|
|
28,772 |
|
|
|
28,772 |
|
Operating
lease right-of-use assets, net |
|
|
43,544 |
|
|
|
43,192 |
|
Deferred tax
asset, net |
|
|
30,014 |
|
|
|
30,014 |
|
Other
assets |
|
|
1,393 |
|
|
|
1,520 |
|
Total assets |
|
$ |
450,313 |
|
|
$ |
449,359 |
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
Current portion of term loan, net of debt issuance costs |
|
$ |
5,480 |
|
|
$ |
4,538 |
|
Current portion of finance lease obligations |
|
|
209 |
|
|
|
- |
|
Current portion of operating lease obligations |
|
|
12,592 |
|
|
|
11,708 |
|
Accounts payable |
|
|
27,390 |
|
|
|
32,330 |
|
Accrued expenses and other current liabilities |
|
|
27,784 |
|
|
|
26,447 |
|
Total current liabilities |
|
|
73,455 |
|
|
|
75,023 |
|
Term loan,
net of current portion and debt issuance costs |
|
|
63,489 |
|
|
|
66,231 |
|
Finance
lease obligations, net of current portion |
|
|
402 |
|
|
|
- |
|
Operating
lease obligations, net of current portion |
|
|
40,495 |
|
|
|
41,314 |
|
Other
liabilities |
|
|
1,190 |
|
|
|
1,122 |
|
Total liabilities |
|
|
179,031 |
|
|
|
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;
132,040,400 and 131,647,677 shares issued; 131,311,852 and
130,919,129 shares outstanding at June 30, 2023 and
December 31, 2022, respectively. |
|
|
13 |
|
|
|
13 |
|
Additional paid-in capital |
|
|
314,838 |
|
|
|
310,957 |
|
Accumulated deficit |
|
|
(43,569 |
) |
|
|
(45,301 |
) |
Total stockholders’ equity |
|
|
271,282 |
|
|
|
265,669 |
|
Total liabilities and stockholders’ equity |
|
$ |
450,313 |
|
|
$ |
449,359 |
|
|
|
|
|
|
|
|
|
|
ORGANOGENESIS HOLDINGS INC. UNAUDITED
CONSOLIDATED STATEMENTS OF OPERATIONS |
(amounts in
thousands, except share and per share data) |
|
|
|
Three Months Ended
June 30, |
|
|
Six Months Ended
June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Net revenue |
|
$ |
117,316 |
|
|
$ |
121,401 |
|
|
$ |
224,958 |
|
|
$ |
218,518 |
|
Cost of
goods sold |
|
|
26,316 |
|
|
|
26,652 |
|
|
|
52,923 |
|
|
|
51,732 |
|
Gross
profit |
|
|
91,000 |
|
|
|
94,749 |
|
|
|
172,035 |
|
|
|
166,786 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
|
70,317 |
|
|
|
72,609 |
|
|
|
144,151 |
|
|
|
136,187 |
|
Research and development |
|
|
10,938 |
|
|
|
10,205 |
|
|
|
22,140 |
|
|
|
18,792 |
|
Total operating expenses |
|
|
81,255 |
|
|
|
82,814 |
|
|
|
166,291 |
|
|
|
154,979 |
|
Income from
operations |
|
|
9,745 |
|
|
|
11,935 |
|
|
|
5,744 |
|
|
|
11,807 |
|
Other
expense, net: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
(594 |
) |
|
|
(730 |
) |
|
|
(1,243 |
) |
|
|
(1,467 |
) |
Other income (expense), net |
|
|
28 |
|
|
|
(21 |
) |
|
|
51 |
|
|
|
(24 |
) |
Total other expense, net |
|
|
(566 |
) |
|
|
(751 |
) |
|
|
(1,192 |
) |
|
|
(1,491 |
) |
Net income
before income taxes |
|
|
9,179 |
|
|
|
11,184 |
|
|
|
4,552 |
|
|
|
10,316 |
|
Income tax
expense |
|
|
(3,863 |
) |
|
|
(2,440 |
) |
|
|
(2,205 |
) |
|
|
(2,485 |
) |
Net
income |
|
$ |
5,316 |
|
|
$ |
8,744 |
|
|
$ |
2,347 |
|
|
$ |
7,831 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income,
per share: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.04 |
|
|
$ |
0.07 |
|
|
$ |
0.02 |
|
|
$ |
0.06 |
|
Diluted |
|
$ |
0.04 |
|
|
$ |
0.07 |
|
|
$ |
0.02 |
|
|
$ |
0.06 |
|
Weighted-average common shares outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
131,293,398 |
|
|
|
129,635,682 |
|
|
|
131,189,405 |
|
|
|
129,214,541 |
|
Diluted |
|
|
133,066,010 |
|
|
|
132,600,579 |
|
|
|
132,475,908 |
|
|
|
132,705,206 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ORGANOGENESIS HOLDINGS INC. UNAUDITED CONSOLIDATED
STATEMENT OF CASH FLOWS |
(amounts in
thousands, except share and per share data) |
|
|
|
Six Months Ended
June 30, |
|
|
|
2023 |
|
|
2022 |
|
Cash
flows from operating activities: |
|
|
|
|
|
|
Net Income |
|
$ |
2,347 |
|
|
$ |
7,831 |
|
Adjustments
to reconcile net income to net cash provided by operating
activities: |
|
|
|
|
|
|
Depreciation |
|
|
4,922 |
|
|
|
2,875 |
|
Amortization of intangible assets |
|
|
2,459 |
|
|
|
2,442 |
|
Reduction in the carrying value of right-of-use assets |
|
|
3,893 |
|
|
|
3,649 |
|
Non-cash interest expense |
|
|
215 |
|
|
|
217 |
|
Deferred interest expense |
|
|
245 |
|
|
|
291 |
|
Provision recorded for credit losses |
|
|
190 |
|
|
|
122 |
|
Loss on disposal of property and equipment |
|
|
65 |
|
|
|
196 |
|
Adjustment for excess and obsolete inventories |
|
|
3,464 |
|
|
|
5,228 |
|
Stock-based compensation |
|
|
4,213 |
|
|
|
2,995 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
Accounts receivable |
|
|
(4,970 |
) |
|
|
(6,485 |
) |
Inventory |
|
|
(4,045 |
) |
|
|
(3,441 |
) |
Prepaid expenses and other current assets |
|
|
(2,874 |
) |
|
|
(1,839 |
) |
Operating leases |
|
|
(4,178 |
) |
|
|
(3,472 |
) |
Accounts payable |
|
|
(3,535 |
) |
|
|
2,671 |
|
Accrued expenses and other current liabilities |
|
|
1,091 |
|
|
|
(1,697 |
) |
Other liabilities |
|
|
67 |
|
|
|
23 |
|
Net cash provided by operating activities |
|
|
3,569 |
|
|
|
11,606 |
|
Cash
flows from investing activities: |
|
|
|
|
|
|
Purchases of
property and equipment |
|
|
(15,061 |
) |
|
|
(12,840 |
) |
Net cash used in investing activities |
|
|
(15,061 |
) |
|
|
(12,840 |
) |
Cash
flows from financing activities: |
|
|
|
|
|
|
Payments of
term loan under the 2021 Credit Agreement |
|
|
(1,875 |
) |
|
|
(938 |
) |
Payments of
withholding taxes in connection with RSUs vesting |
|
|
(332 |
) |
|
|
(646 |
) |
Proceeds
from the exercise of stock options |
|
|
- |
|
|
|
2,042 |
|
Principal
repayments of finance lease obligations |
|
|
(83 |
) |
|
|
(200 |
) |
Payment of
deferred acquisition consideration |
|
|
- |
|
|
|
(608 |
) |
Net cash used in financing activities |
|
|
(2,290 |
) |
|
|
(350 |
) |
Change in cash, cash equivalents and restricted
cash |
|
|
(13,782 |
) |
|
|
(1,584 |
) |
Cash, cash
equivalents, and restricted cash, beginning of period |
|
|
103,290 |
|
|
|
114,528 |
|
Cash, cash
equivalents, and restricted cash, end of period |
|
$ |
89,508 |
|
|
$ |
112,944 |
|
Supplemental disclosure of cash flow
information: |
|
|
|
|
|
|
Cash paid
for interest |
|
$ |
2,608 |
|
|
$ |
1,041 |
|
Cash paid
for income taxes |
|
$ |
3,022 |
|
|
$ |
974 |
|
Supplemental disclosure of non-cash investing and financing
activities: |
|
|
|
|
|
|
Purchases of
property and equipment included in accounts payable and accrued
expenses |
|
$ |
1,882 |
|
|
$ |
6,546 |
|
Right-of-use
assets obtained through lease obligations |
|
$ |
4,253 |
|
|
$ |
364 |
|
Shares
issued for deferred acquisition consideration |
|
$ |
- |
|
|
$ |
828 |
|
|
|
|
|
|
|
|
|
|
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 periods presented:
|
|
Three Months Ended
June 30, |
|
|
Six Months Ended
June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
|
(Unaudited)
(in thousands) |
|
Net Income |
|
$ |
5,316 |
|
|
$ |
8,744 |
|
|
$ |
2,347 |
|
|
$ |
7,831 |
|
Interest expense, net |
|
|
594 |
|
|
|
730 |
|
|
|
1,243 |
|
|
|
1,467 |
|
Income tax expense |
|
|
3,863 |
|
|
|
2,440 |
|
|
|
2,205 |
|
|
|
2,485 |
|
Depreciation |
|
|
2,228 |
|
|
|
1,528 |
|
|
|
4,922 |
|
|
|
2,875 |
|
Amortization |
|
|
1,229 |
|
|
|
1,221 |
|
|
|
2,459 |
|
|
|
2,442 |
|
EBITDA |
|
|
13,230 |
|
|
|
14,663 |
|
|
|
13,176 |
|
|
|
17,100 |
|
Stock-based compensation expense |
|
|
2,299 |
|
|
|
1,692 |
|
|
|
4,213 |
|
|
|
2,995 |
|
Restructuring charge (adjustment) (1) |
|
|
(126 |
) |
|
|
643 |
|
|
|
1,782 |
|
|
|
907 |
|
Settlement fee (2) |
|
|
- |
|
|
|
1,600 |
|
|
|
- |
|
|
|
2,600 |
|
Adjusted
EBITDA |
|
$ |
15,403 |
|
|
$ |
18,598 |
|
|
$ |
19,171 |
|
|
$ |
23,602 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(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 income to non-GAAP adjusted net income, for the periods
presented:
|
|
Three Months Ended
June 30, |
|
|
Six Months Ended
June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
|
(Unaudited)
(in thousands) |
|
|
(in
thousands) |
|
Net Income |
|
$ |
5,316 |
|
|
$ |
8,744 |
|
|
$ |
2,347 |
|
|
$ |
7,831 |
|
Amortization |
|
|
1,229 |
|
|
|
1,221 |
|
|
|
2,459 |
|
|
|
2,442 |
|
Restructuring charge (adjustment) (1) |
|
|
(126 |
) |
|
|
643 |
|
|
|
1,782 |
|
|
|
907 |
|
Settlement fee (2) |
|
|
- |
|
|
|
1,600 |
|
|
|
- |
|
|
|
2,600 |
|
Tax on above |
|
|
(298 |
) |
|
|
(935 |
) |
|
|
(1,145 |
) |
|
|
(1,606 |
) |
Adjusted net
income |
|
$ |
6,121 |
|
|
$ |
11,273 |
|
|
$ |
5,443 |
|
|
$ |
12,174 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(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.
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, 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.
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
(including as a result of the recently published LCDs); (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 focused on the development, manufacture and
commercialization of solutions for the advanced wound care and
surgical and sports medicine markets. Organogenesis offers a
comprehensive portfolio of innovative regenerative products to
address patient needs across the continuum of care. For more
information, visit www.organogenesis.com.
Investor Inquiries:
ICR Westwicke
Mike Piccinino, CFA
OrganoIR@westwicke.com
Press and Media Inquiries:
Organogenesis
Ron O’Brien
communications@organo.com
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