Item 2.02 Results of Operations and Financial Condition.
On February 23, 2021, scPharmaceuticals Inc. (the “Company”) issued a press release which included certain unaudited preliminary financial results for the fourth quarter and fiscal year ended December 31, 2020 (the “Press Release”). A copy of the Press Release is being furnished as Exhibit 99.1 to this Report on Form 8-K.
The information pursuant to Item 2.02 in this Report on Form 8-K and Exhibit 99.1 attached hereto 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 8.01 Other Events.
On February 23, 2021, the Company announced the results of a Type A meeting with the U.S. Food and Drug Administration (the “FDA”) regarding the Company’s FUROSCIX® New Drug Application (“NDA”). As a result of the meeting, the Company will run additional modified bench tests on aged commercial units of the West Pharmaceutical Services, Inc.’s SmartDose® Gen II on-body infusor. The Company also anticipates the need to conduct Pre-Approval Inspections at three of the Company’s third-party manufacturing facilities.
Statements contained under this Item 8.01 regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to: statements regarding the FDA’s review requirements and the Company’s planned resubmission of the FUROSCIX NDA, including potential timing and preparation thereof.
Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include the results of the above-referenced bench testing, the receipt of regulatory approval for the FUROSCIX On-Body Infusor, the risk of cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that the results of previously conducted studies will not be repeated or observed in ongoing or future studies involving our product candidates, and the risk that the current COVID-19 pandemic will impact the Company’s resubmission of the FUROSCIX NDA and other operations. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the United States Securities and Exchange Commission (“SEC”) and quarterly reports on Form 10-Q filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s other filings with the SEC. All forward-looking statements contained in this Current Report on Form 8-K speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
(d) Exhibits
