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): November 4, 2024

Journey Medical Corporation

(Exact Name of Registrant as Specified in Charter)

9237 E Via de Ventura Blvd., Suite 105

Scottsdale, AZ 8525

(Address of principal executive offices)

Registrant’s telephone number, including area code: (480) 434-6670

Check the appropriate box below if the Form 8-K is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

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   x

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 provided pursuant to Section 13(a) of the Exchange Act. ¨

On November 4, 2024, Journey Medical Corporation (“Journey Medical” or the “Company”) announced preliminary estimated unaudited revenue and selected financial results for the three- and nine-month periods ended September 30, 2024. Journey Medical’s consolidated financial statements for these periods are not yet available. These estimates are based on information currently available to management. Journey Medical’s actual results are not expected to vary materially from the estimated preliminary results included herein. The estimates included in this Current Report on Form 8-K have been prepared by, and are the responsibility of management, and Journey Medical’s independent registered public accounting firm has not audited, reviewed, compiled, or performed any procedures with respect to the estimates and does not express an opinion or any other form of assurances with respect thereto.

Based on currently available information, Journey Medical expects to report as follows:

Three-Month Period Ended September 30, 2024

Nine-Month Period Ended September 30, 2024

Other Corporate Update

The information in this Item 2.02 of this Current Report on Form 8-K is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. The information in this Form 8-K shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, except as shall otherwise be expressly set forth by specific reference in such filing.

Updated Financial guidance for the year ended December 31, 2024

                The Company maintains its 2024 financial guidance of the following:

On November 4, 2024, Journey Medical announced that the FDA has approved Emrosi^TM (Minocycline Hydrochloride Extended Release Capsules, 40 mg), formerly referred to as DFD-29, for the treatment of inflammatory lesions of rosacea in adults. Emrosi was developed by Journey Medical in collaboration with DRL. Journey Medical is completing the manufacturing of Emrosi for the U.S. market and anticipates initial supply will be available in late first quarter or early second quarter of 2025. Journey Medical intends to commercialize Emrosi in the U.S. with its commercial team.

As previously disclosed, Journey Medical obtained global rights for the development and commercialization of Emrosi, other than in certain excluded markets, from DRL under a license, collaboration, and assignment agreement (the “DFD-29 Agreement”). Pursuant to the DFD-29 Agreement, the Company is contractually obligated to pay DRL contingent regulatory, commercial, and corporate-based milestone payments. The approval of Emrosi by the FDA on November 4, 2024, triggered a $15.0 million milestone payment obligation to DRL that is due 30 days after the date of the FDA’s approval of the product. Additionally, the Company is required to pay royalties on net sales of Emrosi subject to certain reductions. Milestone payments made upon regulatory approval are capitalized and amortized over the remaining useful life of the related product.

Also as previously disclosed, on December 27, 2023, the Company entered into a Credit Agreement (the “Credit Agreement”) with SWK Funding LLC (“SWK”) that originally provided for a term loan facility in the original principal amount of up to $20.0 million. On July 9, 2024, Journey Medical entered into an amendment to the Credit Agreement with SWK that increased the original principal amount of the credit facility from $20.0 million to $25.0 million. The $5.0 million of additional principal is contractually required to be drawn on by Journey Medical upon FDA approval of DFD-29, subject to the receipt of such approval occurring on or before June 30, 2025. Accordingly, the approval of Emrosi by the FDA triggered the Company’s obligation to draw on the remaining $5.0 million under the Credit Agreement. The Company intends to draw on the $5.0 million in the fourth quarter of 2024 to fund a portion of the $15 million milestone payment noted above.

On November 4, 2024, Journey Medical issued a press release announcing the FDA’s approval of Emrosi a copy of which is attached hereto as Exhibit 99.1 and incorporated herein by reference.

(d) Exhibits.

The following exhibits are furnished herewith:

Forward-Looking Statements

This Current Report on Form 8-K may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. As used below and throughout this Current Report on Form 8-K, the words “the Company”, “we”, “us” and “our” may refer to Journey Medical. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. The words “anticipate,” “believe,” “estimate,” “may,” “expect,” “will,” “could,” “project,” “intend,” “potential” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated include: the fact that our products and product candidates are subject to time and cost intensive regulation and clinical testing and as a result, may never be successfully developed or commercialized; a substantial portion of our sales derive from products that may become subject to third-party generic competition, the introduction of new competitor products, or an increase in market share of existing competitor products, any of which could have a significant adverse impact on our operating income; we operate in a heavily regulated industry, and we cannot predict the impact that any future legislation or administrative or executive action may have on our operations; our revenue is dependent mainly upon sales of our dermatology products and any setback relating to the sale of such products could impair our operating results; competition could limit our products’ commercial opportunity and profitability, including competition from manufacturers of generic versions of our products; the risk that our products do not achieve broad market acceptance, including by government and third-party payors; our reliance third parties for several aspects of our operations; our dependence on our ability to identify, develop, and acquire or in-license products and integrate them into our operations, at which we may be unsuccessful; the dependence of the success of our business, including our ability to finance our company and generate additional revenue, on the successful commercialization of our recently approved product, Emrosi^TM, and any future product candidates that we may develop, in-license or acquire; clinical drug development is very expensive, time consuming, and uncertain and our clinical trials may fail to adequately demonstrate the safety and efficacy of our current or any future product candidates; our competitors could develop and commercialize products similar or identical to ours; risks related to the protection of our intellectual property and our potential inability to maintain sufficient patent protection for our technology and products; our business and operations would suffer in the event of computer system failures, cyber-attacks, or deficiencies in our or our third parties’ cybersecurity; the substantial doubt about our ability to continue as a going concern; the effects of major public health issues, epidemics or pandemics on our product revenues and any future clinical trials; our potential need to raise additional capital; Fortress controls a voting majority of our common stock, which could be detrimental to our other shareholders; as well as other risks described in Part I, Item 1A, “Risk Factors,” in our Annual Report on Form 10-K for the year ended December 31, 2023, subsequent Reports on Form 10-Q, and our other filings we make with the SEC. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.