Item 7.01
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Regulation FD Disclosure.
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On February 12, 2019, Organogenesis Holdings Inc. (ORGO or the Company) reaffirmed the revenue guidance for the fourth quarter and year
ended December 31, 2018 and the year ended December 31, 2019, which was previously provided on January 7, 2019 and is set forth below.
Fourth Quarter and Fiscal 2018
The Company
expects to report net revenue for the fourth quarter of between $62.1 million and $63.1 million, resulting in expected net revenue for the year ended December 31, 2018 of between $192 million and $193 million. ORGO reported
net revenue for the year ended December 31, 2017 of $198.5 million.
The fiscal 2018 forecast assumes (i) net revenue from Advanced Wound
Care products of between $163.1 million and $164 million, representing a decrease in revenue of 8% to 9% over 2017 and (ii) net revenue from Surgical & Sports Medicine products of between $28.9 million and
$29 million, representing an increase of 47% to 48% over 2017. In addition, ORGO has assumed for purposes of this forecast that net revenue from the sale of its PuraPly products will represent between $68.1 million and $69.1 million
of total net revenue, representing a decrease of 37% to 38% over 2017.
Fiscal 2019
In addition, the Company announced total net revenue expectations for the year ended December 31, 2019. For the fiscal 2019 period, the Company expects
total net revenue of between $248 million and $259 million, representing growth of approximately 29% to 35% year-over-year as compared to the midpoint of the expected 2018 results of approximately $192.5 million. The fiscal 2019
forecast assumes (i) net revenue from Advanced Wound Care products of between $219 million and $229 million, representing growth of approximately 34% to 40% year-over-year as compared to the midpoint of the expected 2018 results of
approximately $163.6 million and (ii) net revenue from Surgical & Sports Medicine products of between $29.5 million and $31 million, representing growth of approximately 2% to 7% year-over-year as compared to the
midpoint of the expected 2018 results of approximately $28.9 million. The fiscal 2019 forecast also assumes that net revenue from the sale of its PuraPly products will represent between $96 million and $103 million of total net
revenue, representing growth of approximately 40% to 50% year-over-year as compared to the midpoint of the expected 2018 results of approximately $68.6 million.
Corporate Presentation
A copy of the slide
presentation that will be used by representatives of the Company in connection with investor meetings or presentations from time to time (the Corporate Presentation) is attached to this Current Report on
Form 8-K as
Exhibit 99.1. The Corporate Presentation is current as of February 12, 2019, and the Company disclaims any obligation to correct or update this material in the future.
The information in this
Form 8-K (including
Exhibit 99.1) shall not be deemed filed for purposes
of Section 18 of the Securities Exchange Act of 1934, as amended (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, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Cautionary Note Regarding
Forward-Looking Statements
The Company makes forward-looking statements in this report within the meaning of the Private Securities Litigation
Reform Act of 1995. These forward-looking statements relate to expectations or forecasts for future events. Forward-looking statements may be identified by the use of words such as will, forecast, intend,
seek, target, anticipate, believe, expect, estimate, plan, outlook, extend, 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 Companys expected revenue for fiscal 2018 and fiscal 2019 and the breakdown of
such revenues
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 continued existence and 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 Company has incurred significant losses since inception and
anticipates that it will incur substantial losses for the foreseeable future; (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 Companys 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 Companys ability to raise funds
to expand its business; (6) the impact of any changes to the reimbursement levels for the Companys products and the impact to the Company of the loss of preferred pass through status for PuraPly AM and PuraPly on
October 1, 2020; (7) the Companys ability to successfully appeal Nasdaqs determination to delist the securities and otherwise maintain compliance with applicable Nasdaq listing standards; (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; and (10) other risks and uncertainties described in other documents filed or to be filed with the
Securities and Exchange Commission by the Company. 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.