Organogenesis Holdings Inc. Reports Fourth Quarter and Fiscal Year 2020 Financial Results; Introduces Fiscal Year 2021 Guidance
Organogenesis Holdings (Nasdaq: ORGO) reported Q4 2020 net revenue of $106.8 million, a 43% increase YoY, driven by strong sales in Advanced Wound Care, which rose 48% to $93.6 million. Net income surged to $18.5 million from a loss of $4.4 million in Q4 2019. For FY 2020, total revenue reached $338.3 million, up 30%, with net income of $17.9 million. Looking ahead, the company expects FY 2021 revenue between $390 million and $405 million, reflecting a projected 15-20% growth.
- Q4 2020 net revenue up 43% YoY to $106.8 million.
- Q4 net income rose to $18.5 million from a loss of $4.4 million.
- FY 2020 revenue increased by 30% to $338.3 million.
- FY 2021 guidance expects revenue between $390 million and $405 million (15-20% growth).
- Surgical & Sports Medicine revenue expected to decline by 31-36% YoY in FY 2021.
- PuraPly products revenue guidance indicates a potential decline of up to 6% in FY 2021.
CANTON, Mass., March 16, 2021 (GLOBE NEWSWIRE) -- 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:
- Net revenue of
$106.8 million for the fourth quarter of 2020, up43% compared to net revenue of$74.6 million for the fourth quarter of 2020. Net revenue is based upon:- Net revenue from Advanced Wound Care products for the fourth quarter of 2020 of
$93.6 million , an increase of48% from the fourth quarter of 2019. - Net revenue from Surgical & Sports Medicine products for the fourth quarter of 2020 of
$13.2 million , an increase of17% from the fourth quarter of 2019.
- Net revenue from Advanced Wound Care products for the fourth quarter of 2020 of
- Net revenue from the sale of PuraPly products of
$45.3 million for the fourth quarter of 2020, an increase of13% from the fourth quarter of 2019. - Net revenue from the sale of non-PuraPly products of
$61.5 million , an increase of77% from the fourth quarter of 2019. - Net income of
$18.5 million for the fourth quarter of 2020, compared to a net loss of$4.4 million for the fourth quarter of 2019, an increase of$22.9 million . - 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 .
Fiscal Year 2020 Financial Summary:
- Net revenue of
$338.3 million for the year ended December 31, 2020, up30% compared to net revenue of$261.0 million for the year ended December 31, 2019. Net revenue is based upon:- Net revenue from Advanced Wound Care products of
$294.6 million , up33% year-over-year. - Net revenue from Surgical & Sports Medicine products of
$43.7 million , up9% year-over-year.
- Net revenue from Advanced Wound Care products of
- Net revenue from the sale of PuraPly products of
$147.3 million for the year ended December 31, 2020, up16% year-over-year. - Net revenue from the sale of non-PuraPly products of
$191.0 million for the year ended December 31, 2020, up42% year-over-year. - Net income of
$17.9 million for the year ended December 31, 2020, compared to a net loss of$40.5 million for the year ended December 31, 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.
Fourth Quarter 2020 and Recent Highlights:
- On November 17, 2020, 2020, the Company closed an underwritten public offering of 19,916,708 shares of its Class A common stock, with net proceeds of
$60.1 million . - On January 11, 2021, the Company announced that the U.S. Food and Drug Administration granted ReNu®, a cryopreserved amniotic suspension allograft for the management of symptoms associated with knee osteoarthritis, Regenerative Medicine Advanced Therapy (RMAT) designation.
- On January 14, 2021, the Company announced that the first patient was enrolled in its pivotal Phase 3 clinical trial evaluating the safety and efficacy of ReNu®, a cryopreserved amniotic suspension allograft, for the management of symptoms associated with knee osteoarthritis.
- On February 16, 2021, the Company announced the appointment of David C. Francisco as the Company’s Chief Financial Officer, effective February 15, 2021. In connection with the hiring of Mr. Francisco, Henry Hagopian will serve as the Company’s Senior Vice President of Finance and Treasurer.
“We delivered fourth quarter revenue growth of
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
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:
| Three Months Ended December 31, | Change | ||||||||||||||
| 2020 | 2019 | $ | % | ||||||||||||
| (in thousands, except for percentages) | |||||||||||||||
| Advanced Wound Care | $ | 93,615 | $ | 63,379 | $ | 30,236 | 48 | % | |||||||
| Surgical & Sports Medicine | 13,192 | 11,266 | 1,926 | 17 | % | ||||||||||
| Net revenue | $ | 106,807 | $ | 74,645 | $ | 32,162 | 43 | % | |||||||
Net revenue for the fourth quarter of 2020 was
Gross profit for the fourth quarter of 2020 was
Operating expenses for the fourth quarter of 2020 were
Operating income for the fourth quarter of 2020 was
Total other expenses, net, for the fourth quarter of 2020 were
Net income for the fourth quarter of 2020 was
Adjusted EBITDA was
As of December 30, 2020, the Company had
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:
| Years Ended December 31, | Change | ||||||||||||||||
| 2020 | 2019 | 2020 to 2019 | |||||||||||||||
| (in thousands, except for percentages) | |||||||||||||||||
| Advanced Wound Care | $ | 294,624 | $ | 220,744 | $ | 73,880 | 33 | % | |||||||||
| Surgical & Sports Medicine | 43,674 | 40,237 | 3,437 | 9 | % | ||||||||||||
| Net revenue | $ | 338,298 | $ | 260,981 | $ | 77,317 | 30 | % | |||||||||
Net revenue for the twelve months ended December 30, 2020 was
Net income for the twelve months ended December 30, 2020 was
Adjusted EBITDA of
Fiscal Year 2021 Guidance:
For the twelve months ended December 31, 2021, the Company expects:
- Net revenue of between
$390 million and$405 million , representing an increase of approximately15% to20% year-over-year, as compared to net revenue of$338.3 million for the twelve months ended December 31, 2020.- The 2021 net revenue guidance range assumes:
- Net revenue from Advanced Wound Care products of between
$362 million and$375 million , representing an increase of approximately23% to27% year-over-year as compared to net revenue of$294.6 million for the twelve months ended December 31, 2020. - Net revenue from Surgical & Sports Medicine products of between
$28 million and$30 million , representing a decrease of approximately31% to36% year-over-year as compared to net revenue of$43.7 million for the twelve months ended December 31, 2020. - Net revenue from the sale of PuraPly products of between
$139 million and$147 million , representing a decrease of approximately0% to6% year-over-year, as compared to net revenue of$147.3 million for the twelve months ended December 31, 2020.
- Net revenue from Advanced Wound Care products of between
- The 2021 net revenue guidance range assumes:
- GAAP net income positive for the twelve months ended December 31, 2021.
- Adjusted EBITDA positive for the twelve months ended December 31, 2021.
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)
| December 31, | ||||||||
| 2020 | 2019 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash | $ | 84,394 | $ | 60,174 | ||||
| Restricted cash | 412 | 196 | ||||||
| Accounts receivable, net | 56,804 | 39,359 | ||||||
| Inventory | 27,799 | 22,918 | ||||||
| Prepaid expenses and other current assets | 4,935 | 2,953 | ||||||
| Total current assets | 174,344 | 125,600 | ||||||
| Property and equipment, net | 60,068 | 47,184 | ||||||
| Notes receivable from related parties | — | 556 | ||||||
| Intangible assets, net | 30,622 | 20,797 | ||||||
| Goodwill | 28,772 | 25,539 | ||||||
| Deferred tax asset, net | 18 | 127 | ||||||
| Other assets | 670 | 884 | ||||||
| Total assets | $ | 294,494 | $ | 220,687 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Deferred acquisition consideration | $ | 483 | $ | 5,000 | ||||
| Current portion of term loan | 16,666 | — | ||||||
| Current portion of capital lease obligations | 3,619 | 3,057 | ||||||
| Current portion of deferred rent and lease incentive obligation | 95 | — | ||||||
| Accounts payable | 23,381 | 28,387 | ||||||
| Accrued expenses and other current liabilities | 23,973 | 23,450 | ||||||
| Total current liabilities | 68,217 | 59,894 | ||||||
| Line of credit | 10,000 | 33,484 | ||||||
| Term loan, net of current portion | 43,044 | 49,634 | ||||||
| Deferred acquisition consideration, net of current portion | 1,436 | — | ||||||
| Earnout liability | 3,985 | — | ||||||
| Deferred rent and lease incentive obligation, net of current portion | 2,315 | 1,012 | ||||||
| Capital lease obligations, net of current portion | 11,442 | 14,431 | ||||||
| Other liabilities | 7,971 | 6,649 | ||||||
| Total liabilities | 148,410 | 165,104 | ||||||
| Commitments and contingencies (Note 18) | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, | — | — | ||||||
| Common stock, | 13 | 10 | ||||||
| Additional paid-in capital | 299,129 | 226,580 | ||||||
| Accumulated deficit | (153,058 | ) | (171,007 | ) | ||||
| Total stockholders' equity | 146,084 | 55,583 | ||||||
| Total liabilities and stockholders' equity | $ | 294,494 | $ | 220,687 | ||||
| - | ||||||||
ORGANOGENESIS HOLDINGS INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(amounts in thousands, except share and per share data)
| (unaudited) | ||||||||||||||||
| Three Months Ended December 31, | Twelve Months Ended, December 31 | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Net revenue | $ | 106,807 | $ | 74,645 | $ | 338,298 | $ | 260,981 | ||||||||
| Cost of goods sold | 25,520 | 20,391 | 87,319 | 75,948 | ||||||||||||
| Gross profit | 81,287 | 54,254 | 250,979 | 185,033 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Selling, general and administrative | 53,217 | 52,368 | 203,478 | 199,693 | ||||||||||||
| Research and development | 6,299 | 3,640 | 20,086 | 14,799 | ||||||||||||
| Total operating expenses | 59,516 | 56,008 | 223,564 | 214,492 | ||||||||||||
| Income (loss) from operations | 21,771 | (1,754 | ) | 27,415 | (29,459 | ) | ||||||||||
| Other expense, net: | ||||||||||||||||
| Interest expense, net | (2,888 | ) | (2,604 | ) | (11,279 | ) | (8,996 | ) | ||||||||
| Gain on settlement of deferred acquisition consideration | — | — | 2,246 | — | ||||||||||||
| Loss on the extinguishment of debt | — | — | — | (1,862 | ) | |||||||||||
| Other income, net | 7 | 2 | 97 | 13 | ||||||||||||
| Total other expense, net | (2,881 | ) | (2,602 | ) | (8,936 | ) | (10,845 | ) | ||||||||
| Net income (loss) before income taxes | 18,890 | (4,356 | ) | 18,479 | (40,304 | ) | ||||||||||
| Income tax expense | (396 | ) | (42 | ) | (530 | ) | (150 | ) | ||||||||
| Net income (loss) | 18,494 | (4,398 | ) | 17,949 | (40,454 | ) | ||||||||||
| Non-cash deemed dividend to warrant holders | — | — | — | (645 | ) | |||||||||||
| Net income (loss) attributed to common shareholders | $ | 18,494 | $ | (4,398 | ) | $ | 17,949 | $ | (41,099 | ) | ||||||
| Net income (loss) attributed to common shareholders, per share: | ||||||||||||||||
| Basic | $ | 0.16 | $ | (0.04 | ) | $ | 0.17 | $ | (0.44 | ) | ||||||
| Diluted | $ | 0.15 | $ | (0.04 | ) | $ | 0.16 | $ | (0.44 | ) | ||||||
| Weighted-average common shares outstanding | ||||||||||||||||
| Basic | 116,641,862 | 97,760,835 | 107,737,936 | 92,840,401 | ||||||||||||
| Diluted | 120,716,431 | 97,760,835 | 111,360,831 | 92,840,401 | ||||||||||||
ORGANOGENESIS HOLDINGS INC.
CONSOLIDATED STATEMENT OF CASH FLOWS
(amounts in thousands, except share and per share data)
| Year Ended December 31, | ||||||||||||
| 2020 | 2019 | 2018 | ||||||||||
| Cash flows from operating activities: | ||||||||||||
| Net income (loss) | $ | 17,949 | $ | (40,454 | ) | $ | (64,831 | ) | ||||
| Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: | ||||||||||||
| Depreciation | 3,723 | 3,388 | 3,309 | |||||||||
| Amortization of intangible assets | 3,745 | 6,043 | 3,669 | |||||||||
| Non-cash interest expense | 236 | 243 | 845 | |||||||||
| Deferred interest expense | 2,133 | 1,446 | 249 | |||||||||
| Deferred rent expense and lease incentive obligation | 1,273 | 882 | 56 | |||||||||
| Gain on settlement of deferred acquisition consideration | (2,246 | ) | — | — | ||||||||
| Recovery of certain notes receivable from related parties | (1,516 | ) | — | — | ||||||||
| Deferred tax expense | 112 | 111 | 186 | |||||||||
| Loss on disposal of property and equipment | 201 | 146 | 1,209 | |||||||||
| Write-off of deferred offering costs | — | — | 3,494 | |||||||||
| Provision recorded for sales returns and doubtful accounts | 2,441 | 239 | 1,157 | |||||||||
| Adjustment for excess and obsolete inventories | 3,050 | 1,297 | 2,473 | |||||||||
| Stock-based compensation | 1,661 | 936 | 1,075 | |||||||||
| Change in fair value of warrant liability | — | — | 469 | |||||||||
| Loss of extinguishment of debt | — | 1,862 | 2,095 | |||||||||
| Change in fair value of Earnout liability | 203 | — | — | |||||||||
| Changes in fair value of forfeiture rights | — | — | 589 | |||||||||
| Changes in operating assets and liabilities: | ||||||||||||
| Accounts receivable | (18,825 | ) | (4,691 | ) | (7,110 | ) | ||||||
| Inventory | (6,700 | ) | (11,063 | ) | (1,524 | ) | ||||||
| Prepaid expenses and other current assets | (971 | ) | (625 | ) | (1,414 | ) | ||||||
| Accounts payable | (635 | ) | 4,700 | (60 | ) | |||||||
| Accrued expenses and other current liabilities | 1,443 | 2,942 | 2,354 | |||||||||
| Accrued interest - affiliate debt | — | — | (9,241 | ) | ||||||||
| Other liabilities | (476 | ) | (930 | ) | 316 | |||||||
| Net cash provided by (used in) operating activities | 6,801 | (33,528 | ) | (60,635 | ) | |||||||
| Cash flows from investing activities: | ||||||||||||
| Purchases of property and equipment | (21,145 | ) | (5,984 | ) | (1,857 | ) | ||||||
| Proceeds from the repayment of notes receivable from related parties | 2,132 | — | — | |||||||||
| Cash paid for business acquisition | (5,820 | ) | — | — | ||||||||
| Acquisition of intangible asset | — | (250 | ) | — | ||||||||
| Proceeds from disposal of property and equipment | — | — | 1 | |||||||||
| Net cash used in investing activities | (24,833 | ) | (6,234 | ) | (1,856 | ) | ||||||
| Cash flows from financing activities: | ||||||||||||
| Line of credit borrowings (repayments), net | (23,484 | ) | 7,000 | 8,866 | ||||||||
| Proceeds from term loan | 10,000 | 50,000 | — | |||||||||
| Proceeds from long-term debt - affiliates | — | — | 15,000 | |||||||||
| Proceeds from equity financing | 64,729 | 50,340 | 92,000 | |||||||||
| Payment of equity issuance costs | (5,656 | ) | (2,973 | ) | (270 | ) | ||||||
| Payment of recapitalization costs | — | — | (11,206 | ) | ||||||||
| Repayment of debt and debt issuance cost on affiliate debt | — | — | (22,680 | ) | ||||||||
| Repayment of notes payable | — | (17,585 | ) | (10 | ) | |||||||
| Principal repayments of capital lease obligations | (2,427 | ) | (1,266 | ) | (104 | ) | ||||||
| Redemption of redeemable common stock placed into treasury | — | (6,762 | ) | — | ||||||||
| Proceeds from the exercise of stock options | 2,823 | 269 | 119 | |||||||||
| Proceeds from the exercise of common stock warrants | — | 628 | — | |||||||||
| Payments of deferred acquisition consideration | (3,517 | ) | — | — | ||||||||
| Payment of debt issuance costs | — | (924 | ) | (177 | ) | |||||||
| Net cash provided by financing activities | 42,468 | 78,727 | 81,538 | |||||||||
| Change in cash and restricted cash | 24,436 | 38,965 | 19,047 | |||||||||
| Cash and restricted cash, beginning of year | 60,370 | 21,405 | 2,358 | |||||||||
| Cash and restricted cash, end of year | $ | 84,806 | $ | 60,370 | $ | 21,405 | ||||||
| Supplemental disclosure of cash flow information: | ||||||||||||
| Cash paid for interest | $ | 9,609 | $ | 8,148 | $ | 5,423 | ||||||
| Cash paid for income taxes | $ | 61 | $ | 49 | $ | 8 | ||||||
| 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 | $ | 5,218 | $ | — | $ | — | ||||||
| Fair value of shares issued in connection with investor debt settlement | $ | — | $ | — | $ | 42,764 | ||||||
| Fair value of shares issued in connection with settlement of investor warrants | $ | — | $ | — | $ | 2,707 | ||||||
| Common stock issued in exchange for APHAC shares | $ | — | $ | — | $ | 1 | ||||||
| Notice of put option exercise of redeemable common shares | $ | — | $ | — | $ | 6,762 | ||||||
| Non-cash deemed dividend related to warrant exchange | $ | — | $ | 645 | $ | — | ||||||
| Equity issuance costs included in accounts payable | $ | — | $ | 537 | $ | — | ||||||
| Purchases of property and equipment in accounts payable and accrued expenses | $ | 2,391 | $ | 4,014 | $ | 172 | ||||||
| Acquisition of intangible assets included in accrued expenses and other liabilities | $ | — | $ | 500 | $ | — | ||||||
| Equipment acquired under capital lease | $ | — | $ | 1,099 | $ | — | ||||||
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:
| (unaudited) Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| (in thousands) | (in thousands) | |||||||||||||||
| Net income (loss) attributable to Organogenesis Holdings Inc. | $ | 18,494 | $ | (4,398 | ) | $ | 17,949 | $ | (40,454 | ) | ||||||
| Interest expense, net | 2,888 | 2,604 | 11,279 | 8,996 | ||||||||||||
| Income tax expense | 396 | 42 | 530 | 150 | ||||||||||||
| Depreciation | 974 | 835 | 3,723 | 3,388 | ||||||||||||
| Amortization | 1,227 | 1,517 | 3,745 | 6,043 | ||||||||||||
| EBITDA | 23,979 | 600 | 37,226 | (21,877 | ) | |||||||||||
| Stock-based compensation expense | 497 | 236 | 1,661 | 936 | ||||||||||||
| Restructuring charge (1) | 618 | - | 618 | - | ||||||||||||
| Gain on settlement of deferred acquisition consideration (2) | - | - | (2,246 | ) | - | |||||||||||
| Recovery of certain notes receivable from related parties (3) | (405 | ) | - | (1,516 | ) | - | ||||||||||
| Change in fair value of Earnout (4) | 203 | - | 203 | - | ||||||||||||
| Loss on extinguishment of debt (5) | - | - | - | 1,862 | ||||||||||||
| Exchange offer transaction costs (6) | - | - | - | 916 | ||||||||||||
| CPN transaction costs (7) | - | - | 929 | - | ||||||||||||
| Adjusted EBITDA | $ | 24,892 | $ | 836 | $ | 36,875 | $ | (18,163 | ) | |||||||
________________________________
(1) Amount reflects employee retention and other benefit-related costs related to the Company’s restructuring activities in the fourth quarter ended December 31, 2020.
(2) Amount reflects the gain recognized related to the settlement of the deferred acquisition consideration dispute with the sellers of NuTech Medical in February 2020 as well as the settlement of the assumed legacy lawsuit from the sellers of NuTech Medical in October 2020.
(3) Amount reflects the collection of certain notes receivable from related parties previously reserved.
(4) Amount reflects the change in the fair value of the Earnout liability in connection with the CPN acquisition.
(5) Amounts reflect the amount of loss recognized on the extinguishment of the Master Lease Agreement upon repayment in 2019 and the amount of loss recognized on the repayment and conversion to equity of the affiliated debt in December 2018.
(6) Amount reflects legal, advisory, and other professional fees incurred in the quarter ended September 30, 2019 related directly to the warrant exchange transactions.
(7) Amount reflects the legal, advisory, and other professional fees incurred in the nine months ended September 30, 2020 related directly to the CPN acquisition.
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.
FAQ
What were Organogenesis Holdings' Q4 2020 financial results?
How did Organogenesis perform in FY 2020?
What is the revenue guidance for Organogenesis in FY 2021?
What are the revenue expectations for Advanced Wound Care products in FY 2021?
What decline is expected for Surgical & Sports Medicine revenue in FY 2021?
