Minocycline

PDUFA goal date of November 4, 2024 for DFD-29 for the treatment of inflammatory lesions and erythema of rosacea in adults FDA accepted Biologics License Application resubmission for cosibelimab to treat metastatic or locally advanced cutaneous squamous cell carcinoma; PDUFA goal date of December 28, 2024 MIAMI, Aug. 13, 2024 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue, today announced financial results and recent corporate highlights for the second quarter ended June 30, 2024. Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, “We had a very productive first half of the year and we anticipate an exciting second half, as we have a New Drug Application (“NDA”) and a Biologics License Application (“BLA”) on file with the U.S. Food and Drug Administration (“FDA”) from our diversified portfolio, both with PDUFA goal dates in the fourth quarter, including DFD-29 for rosacea and cosibelimab for metastatic and locally advanced cutaneous squamous cell carcinoma (“cSCC”). Our late-stage candidates could generate up to three regulatory approvals in the next 12 months and a potential fourth BLA submission as early as 2025. Additionally, we had a solid second quarter 2024 of product revenue from our marketed dermatology products of $14.9 million, representing growth of approximately 15% compared to first quarter 2024 product revenues of $13.0 million. We continue to prioritize the development of our candidates and the expansion of our business for long-term success. This involves business development efforts and the growth of additional revenue streams, all aimed at benefiting our shareholders. Our business model provides the potential for significant growth as we acquire new assets and our subsidiary and partner companies grow in value, allowing for the opportunity to collect diversified cashflows such as royalties, milestones, product revenues, cash and stock dividends and through meaningful monetizations.” Recent Corporate Highlights1: Regulatory Updates In March 2024, the FDA accepted the NDA for DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) and set a PDUFA goal date of November 4, 2024. If approved, DFD-29 has the potential to be the new treatment paradigm for the millions of patients suffering from inflammatory lesions and erythema of rosacea. Both double blinded, randomized controlled DFD-29 Phase 3 clinical trials achieved their co-primary and all secondary endpoints with subjects completing the 16-week treatment with no significant safety issues. DFD-29 demonstrated statistical superiority compared to both Oracea capsules and placebo for Investigator’s Global Assessment (IGA) treatment success and the reduction in the total inflammatory lesion count in both clinical trials. Additionally, DFD-29 showed significantly superior reduction in Clinicians Erythema Assessment compared to placebo in both of the Phase 3 clinical trials. DFD-29 is currently in development at our partner company, Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”).In July 2024, the FDA accepted the BLA resubmission for cosibelimab, our investigational anti-PD-L1 antibody, as a treatment for patients with metastatic or locally advanced cSCC who are not candidates for curative surgery or radiation, and set a PDUFA goal date of December 28, 2024. In June 2024, we reached alignment with the FDA on our BLA resubmission strategy for cosibelimab and announced the resubmission of the BLA in July 2024. Cosibelimab is currently in development at our partner company, Checkpoint Therapeutics, Inc. (Nasdaq: CKPT) (“Checkpoint”). Clinical Updates In May 2024, we announced that the last patient had completed dosing in a Phase 1b/2a study evaluating AJ201 in the U.S. for the treatment of spinal and bulbar muscular atrophy (“SBMA”), also known as Kennedy’s Disease. SBMA is a debilitating rare genetic neuromuscular disease primarily affecting men. Topline data for the Phase 1b/2a clinical trial of AJ201 to treat SBMA are currently expected in the second half of 2024. A webcast replay of the Key Opinion Leader event that took place in April 2024 highlighting expert perspectives on SBMA is available on the Events page of Avenue’s website at https://avenuetx.com/. AJ201 is currently in development at our partner company, Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue”).The Phase 2 clinical trial of Triplex, a cytomegalovirus vaccine, for adults co-infected with Human Immunodeficiency Virus (“HIV”) and CMV is now fully enrolled with topline data anticipated in the fourth quarter of 2024. The study aims to show that vaccination with Triplex can safely elicit a CMV-specific immune response and reduce asymptomatic CMV replication in a population of people with HIV on suppressive antiretroviral therapy. The study will also evaluate whether this intervention might reduce chronic inflammation and immune activation, as compared to placebo, and thus, potentially reduce related mortality and morbidity. Triplex is currently in development at our subsidiary company, Helocyte, Inc.In May 2024, we announced that the first patient was dosed in a multi-center, placebo-controlled, randomized Phase 2 study of Triplex, a vaccine for control of CMV, in patients undergoing liver transplantation. The trial will enroll up to 416 CMV seronegative prospective liver transplant recipients and will be conducted across up to 20 nationally recognized transplant centers in the U.S. The trial is funded by a grant from the National Institute of Allergy and Infectious Diseases of the National Institutes of Health that could provide over $20 million in non-dilutive funding. We believe this data set could ultimately be used to support the approval of Triplex in this setting. Other Updates In July 2024, we announced a collaboration to explore the combined therapeutic potential of cosibelimab, our anti-PD-L1 antibody, with GC Cell’s Immuncell-LC, an innovative autologous Cytokine Induced Killer (“CIK”) T cell therapy composed of cytotoxic T lymphocytes and natural killer T cells.In July 2024, our majority owned and controlled subsidiary company, Urica Therapeutics, Inc. (“Urica”), entered into an asset purchase agreement, royalty agreement, and related agreements (collectively, the “Transaction Documents”) with Crystalys Therapeutics, Inc. (“Crystalys”). Crystalys is a Delaware corporation incorporated in 2022 and seeded by leading life sciences institutional investors. Under the Transaction Documents, Urica transferred rights to its URAT1 inhibitor product candidate in development for the treatment of gout, dotinurad, and related intellectual property, licenses and agreements to Crystalys. In return, Crystalys issued to Urica shares of its common stock equal to 35% of Crystalys’ outstanding equity. The Transaction Documents also grant Urica a securitized three percent (3%) royalty on future net sales of dotinurad to be paid by Crystalys, as well as the right to receive nominal cash reimbursement payments for certain clinical and development costs incurred by Urica related to dotinurad.In October 2023, we announced an exclusive worldwide option agreement with City of Hope (“COH”) to license certain intellectual property relating to a CMV/HIV bi-specific Chimeric Antigen Receptor (“CAR”) (collectively, CMV/HIV-CAR) T cell program for the treatment of adults living with HIV, optionally in combination with Triplex. Additionally, the California Institute for Regenerative Medicine awarded a $11.3 million grant to COH to fund a Phase 1 clinical trial involving the CMV/HIV-CAR T. In preclinical studies, administration of the bi-specific CAR T cells followed by administration of a CMV vaccine successfully eradicated HIV, including from latent reservoirs. Commercial Product Updates Journey Medical’s total net revenues for the second quarter ended June 30, 2024 were $14.9 million, compared to total net revenues of $13.0 million for the first quarter ended March 31, 2024. General Corporate: In April 2024, Avenue announced the exercise of warrants for $4.4 million in gross proceeds and a 1-for-75 reverse split of its issued and outstanding common stock.In May and June 2024, Mustang Bio raised approximately $6.5 million across two offerings of its common stock and warrants.In July 2024, Checkpoint raised $12 million in a registered direct offering priced at-the-market under Nasdaq rules.In July 2024, Fortress’ Board of Directors paused the payment of dividends on the Company’s 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock (the “Series A Preferred Stock”) until further notice. The Company believes pausing the dividend is in the best interest of the Company and its stakeholders to maintain financial flexibility ahead of potentially significant inflection points. Dividends on the Series A Preferred Stock accrue in accordance with their terms; the pausing of these dividends will defer approximately $0.7 million in cash dividend payments each month. The Board intends to revisit its decision regarding the monthly dividend regularly and will assess the profitability and cash flow of the Company to determine whether and when the suspension should be lifted.Also in July 2024, Fortress reduced its total debt by entering into a new loan agreement maturing in July 2027 with funds managed by Oaktree Capital Management, L.P. (“Oaktree”), a leading global investment firm. The Company received an initial tranche of $35 million and is eligible to draw an additional $15 million with Oaktree’s consent. In connection with the new loan agreement, the Company repaid its prior term loan with Oaktree of $50 million resulting in a net paydown of $15 million of debt excluding accrued interest and prepayment fees. Financial Results: As of June 30, 2024, Fortress’ consolidated cash and cash equivalents totaled $76.2 million, compared to $83.8 million as of March 31, 2024 and compared to $80.9 million as of December 31, 2023, a decrease of $7.6 million during the quarter and a decrease of $4.7 million year-to-date.Fortress’ consolidated cash and cash equivalents, totaling $76.2 million as of June 30, 2024, includes $38.2 million attributable to Fortress and the private subsidiaries, $4.9 million attributable to Avenue, $5.0 million attributable to Checkpoint, $4.3 million attributable to Mustang Bio and $23.9 million attributable to Journey Medical. Fortress’ consolidated cash and cash equivalents totaled $80.9 million as of December 31, 2023, which included $40.6 million attributable to Fortress and private subsidiaries, $1.8 million attributable to Avenue, $4.9 million attributable to Checkpoint, $6.2 million attributable to Mustang Bio and $27.4 million attributable to Journey Medical. Fortress’ consolidated net revenue totaled $14.9 million for the second quarter ended June 30, 2024, most of which was generated from our marketed dermatology products. This compares to consolidated revenue totaling $17.4 million for the second quarter of 2023, which included $17.0 million in revenue generated from our marketed dermatology products.Consolidated research and development expenses including license acquisitions totaled $12.7 million for the second quarter ended June 30, 2024, compared to $32.1 million for the second quarter ended June 30, 2023.Consolidated selling, general and administrative costs were $20.8 million for the second quarter ended June 30, 2024, compared to $24.4 million for the second quarter ended June 30, 2023.Consolidated net loss attributable to common stockholders was $(13.3) million, or $(0.73) per share, for the second quarter ended June 30, 2024, compared to net loss attributable to common stockholders of $(26.9) million, or $(3.65) per share for the second quarter ended June 30, 2023. About Fortress Biotech Fortress Biotech, Inc. (“Fortress”) is an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue. The company has seven marketed prescription pharmaceutical products and over 20 programs in development at Fortress, at its majority-owned and majority-controlled partners and subsidiaries and at partners and subsidiaries it founded and in which it holds significant minority ownership positions. Fortress’ portfolio is being commercialized and developed for various therapeutic areas including oncology, dermatology, and rare diseases. Fortress’ model is focused on leveraging its significant biopharmaceutical industry expertise and network to further expand and advance the company’s portfolio of product opportunities. Fortress has established partnerships with some of the world’s leading academic research institutions and biopharmaceutical companies to maximize each opportunity to its full potential, including AstraZeneca, City of Hope, Fred Hutchinson Cancer Center, Nationwide Children’s Hospital and Sentynl. For more information, visit www.fortressbiotech.com. Forward-Looking StatementsStatements in this press release that are not descriptions of historical facts are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended. The words “anticipates,” “believes,” “can,” “continue,” “could,” “estimates,” “expects,” “intends,” “may,” “might,” “plans,” “potential,” “predicts,” “should,” or “will” or the negative of these terms or other comparable terminology are generally intended to identify forward-looking statements. These 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 risks relating to: our growth strategy, financing and strategic agreements and relationships; the ongoing UTRF litigation and our indemnification of Caelum in connection therewith; our need for substantial additional funds and uncertainties relating to financings; our ability to identify, acquire, close and integrate product candidates successfully and on a timely basis; our ability to attract, integrate and retain key personnel; the early stage of products under development; the results of research and development activities; uncertainties relating to preclinical and clinical testing; our ability to obtain regulatory approval for products under development; our ability to successfully commercialize products for which we receive regulatory approval or receive royalties or other distributions from third parties; our ability to secure and maintain third-party manufacturing, marketing and distribution of our and our partner companies’ products and product candidates; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. 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. The information contained herein is intended to be reviewed in its totality, and any stipulations, conditions or provisos that apply to a given piece of information in one part of this press release should be read as applying mutatis mutandis to every other instance of such information appearing herein. Company Contact:Jaclyn JaffeFortress Biotech, Inc.(781) 652-4500ir@fortressbiotech.com Media Relations Contact:Tony Plohoros6 Degrees(908) 591-2839tplohoros@6degreespr.com FORTRESS BIOTECH, INC. AND SUBSIDIARIESUnaudited Condensed Consolidated Balance Sheets ($ in thousands except for share and per share amounts) June 30, December 31, 2024 2023 ASSETS Current assets Cash and cash equivalents $76,201 $80,927 Accounts receivable, net 10,465 15,222 Inventory 9,687 10,206 Other receivables - related party 224 167 Prepaid expenses and other current assets 4,649 10,500 Assets held for sale 2,209 — Total current assets 103,435 117,022 Property, plant and equipment, net 3,546 6,505 Operating lease right-of-use asset, net 14,626 16,990 Restricted cash 2,063 2,438 Intangible assets, net 18,658 20,287 Other assets 3,357 4,284 Total assets $ 145,685 $ 167,526 LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) Current liabilities Accounts payable and accrued expenses $68,921 $73,562 Income taxes payable 806 843 Common stock warrant liabilities 172 886 Operating lease liabilities, short-term 2,481 2,523 Partner company convertible preferred shares, short-term, net — 3,931 Partner company installment payments - licenses, short-term, net 3,000 3,000 Other short-term liabilities 163 163 Total current liabilities 75,543 84,908 Notes payable, long-term, net 67,007 60,856 Operating lease liabilities, long-term 15,934 18,282 Other long-term liabilities 1,799 1,893 Total liabilities 160,283 165,939 Commitments and contingencies Stockholders’ equity (deficit) Cumulative redeemable perpetual preferred stock, $0.001 par value, 15,000,000 authorized, 5,000,000 designated Series A shares, 3,427,138 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively, liquidation value of $25.00 per share 3 3 Common stock, $0.001 par value, 200,000,000 shares authorized, 22,587,038 and 15,093,053 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively 23 15 Additional paid-in-capital 739,086 717,396 Accumulated deficit (721,235) (694,870)Total stockholders' equity attributed to the Company 17,877 22,544 Non-controlling interests (32,475) (20,957)Total stockholders' equity (deficit) (14,598) 1,587 Total liabilities and stockholders' equity (deficit) $ 145,685 $ 167,526 FORTRESS BIOTECH, INC. AND SUBSIDIARIESUnaudited Condensed Consolidated Statements of Operations($ in thousands except for share and per share amounts) Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023Revenue Product revenue, net $14,855 $16,961 $27,885 $29,126 Collaboration revenue — 183 — 364 Revenue - related party 41 31 41 66 Other revenue — 211 — 259 Net revenue 14,896 17,386 27,926 29,815 Operating expenses Cost of goods sold - product revenue 6,541 7,767 13,357 14,216 Research and development 12,671 32,139 37,495 67,415 Research and development - licenses acquired — 3 — 4,233 Selling, general and administrative 20,823 24,439 38,777 49,780 Asset impairment 2,649 3,143 2,649 3,143 Total operating expenses 42,684 67,491 92,278 138,787 Loss from operations (27,788) (50,105) (64,352) (108,972) Other income (expense) Interest income 734 715 1,567 1,751 Interest expense and financing fee (2,122) (6,425) (4,724) (10,721)Change in fair value of warrant liabilities — (512) — 6,166 Gain (loss) on common stock warrant liabilities 70 — (597) — Loss from deconsolidation of subsidiaries — (3,369) — (3,369)Other income (expense) 282 395 260 699 Total other income (expense) (1,036) (9,196) (3,494) (5,474)Net loss (28,824) (59,301) (67,846) (114,446) Net loss attributable to non-controlling interests 17,876 34,525 41,481 68,133 Net loss attributable to Fortress $ (10,948) $ (24,776) $ (26,365) $ (46,313) Net loss attributable to common stockholders $ (13,339) $ (26,917) $ (31,199) $ (50,595) Net loss per common share attributable to common stockholders - basic and diluted $(0.73) $(3.65) $(1.76) $(7.14) Weighted average common shares outstanding - basic and diluted 18,316,874 7,377,332 17,736,299 7,086,482 1 The development programs depicted in this press release include product candidates in development at Fortress, at Fortress’ private subsidiaries (referred to herein as “subsidiaries”), at Fortress’ public subsidiaries (referred to herein as “partner companies”) and at entities with whom one of the foregoing parties has a significant business relationship, such as an exclusive license or an ongoing product-related payment obligation (such entities referred to herein as “partners”). The words “we”, “us” and “our” may refer to Fortress individually, to one or more of our subsidiaries and/or partner companies, or to all such entities as a group, as dictated by context.

New Drug Application for DFD-29 to treat rosacea under FDA review; PDUFA goal date of November 4, 2024 Total revenues for the second quarter ended June 30, 2024 were $14.9 million, a 14% increase from the $13.0 million reported in the first quarter of 2024 Company to hold conference call today at 4:30 p.m. ET to discuss the financial results and provide a business update SCOTTSDALE, Ariz., Aug. 12, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical” or “the Company”), a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of U.S. Food and Drug Administration (“FDA”)-approved prescription pharmaceutical products for the treatment of dermatological conditions, today announced financial results and recent corporate highlights for the second quarter ended June 30, 2024. Claude Maraoui, Journey Medical’s Co-Founder, President and Chief Executive Officer, said, “We continued to execute on our business plan in the second quarter, delivering $14.9 million in total net product revenue and positive Adjusted EBITDA. We are pleased with these results, particularly given our strategic decision to reduce the Company’s expense base in 2023. We believe that the business is now sufficiently right-sized to support our core dermatology franchise and effectively launch DFD-29. We’re looking forward to the DFD-29 PDUFA date and anticipate a productive second half of 2024 with additional business progress and continued financial performance. Importantly, we grew revenue 14% sequentially from the first quarter of this year as we remain on track to deliver on our 2024 financial guidance. We also strengthened our corporate team with the appointment of Joseph M. Benesch as our permanent Chief Financial Officer and the appointment of Michael C. Pearce to our Board of Directors.” Financial Results: Total net product revenues were $14.9 million for the second quarter of 2024, a 12% decrease compared to the second quarter of 2023. The decrease from the prior-year period was primarily due to the timing of customer orders for Qbrexza®, continued generic competition for Targadox®, and our decision to discontinue Ximino® at the end of the third quarter of 2023. Net product revenues in the second quarter of 2024 increased by 14% sequentially from the first quarter of 2024. Research and development costs were $0.9 million in the second quarter of 2024, compared to $1.8 million in the second quarter of 2023. The decrease is due to lower clinical trial expenses to develop DFD-29, as the clinical phase of the project has concluded. Selling, general and administrative expenses were $10.3 million for the second quarter 2024, a $1.8 million decrease from the $12.1 million reported in the second quarter of 2023. The decrease is due to the Company’s expense reduction efforts initiated in 2023. The Company significantly reduced its net loss by $5.0 million, from a net loss of $8.4 million or $(0.46) per share basic and diluted, for the second quarter of 2023, to a net loss of $3.4 million or $(0.17) per share basic and diluted, for the second quarter of 2024. The Company’s non-GAAP results in the table below reflect positive Adjusted EBITDA of $0.3 million, or $0.02 per share basic and $0.01 per share diluted, for the second quarter of 2024. This compares to negative Adjusted EBITDA of $(0.6 million), or $(0.04) per share basic and diluted, for the second quarter of 2023. Adjusted EBITDA, Adjusted EBITDA per share basic and Adjusted EBITDA per share diluted are non-GAAP financial measures, each of which is reconciled to the most directly comparable financial measures calculated in accordance with GAAP below under “Use of Non-GAAP Measures.”At June 30, 2024, the Company had $23.9 million in cash and cash equivalents, as compared to $24.1 million at March 31, 2024, and $27.4 million at December 31, 2023. Recent Corporate Highlights: In March 2024, the FDA accepted the Company’s NDA filing for DFD-29 and set a PDUFA goal date of November 4, 2024. If approved, DFD-29 has the potential to be the only oral, systemic therapy to address both inflammatory lesions and erythema (redness) from rosacea, differentiating it as a potential best-in-class solution for the millions of patients suffering from rosacea. Journey Medical submitted its NDA to the FDA seeking approval for DFD-29 in January 2024. In April 2024, Journey Medical appointed Joseph M. Benesch as its Chief Financial Officer. Mr. Benesch served as Journey Medical’s Interim Chief Financial Officer since January 2023 and previously, he was Corporate Controller at the Company since November 2021. In July 2024, Journey Medical appointed Michael C. Pearce to its Board of Directors. Mr. Pearce is an accomplished executive, with substantial strategic, business and financial experience across many industries, including healthcare. Conference Call and Webcast InformationJourney Medical management will conduct a conference call and audio webcast on August 12, 2024, at 4:30 p.m. ET. To listen to the conference call, interested parties within the U.S. should dial 1-866-777-2509 (domestic) or 1-412-317-5413 (international). All callers should dial in approximately 10 minutes prior to the scheduled start time and ask to be joined into the Journey Medical conference call. Participants can register for the conference here: https://dpregister.com/sreg/10190841/fd0fed9bae. Please note that registered participants will receive their dial-in number upon registration. A live audio webcast can be accessed on the News and Events page of the Investors section of Journey Medical’s website, www.journeymedicalcorp.com, and will remain available for replay for approximately 30 days after the meeting. About Journey Medical CorporationJourney Medical Corporation (Nasdaq: DERM) (“Journey Medical”) is a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of FDA-approved prescription pharmaceutical products for the treatment of dermatological conditions through its efficient sales and marketing model. The Company currently markets seven branded and two generic products that help treat and heal common skin conditions. The Journey Medical team comprises industry experts with extensive experience in developing and commercializing some of dermatology’s most successful prescription brands. Journey Medical is located in Scottsdale, Arizona and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). Journey Medical’s common stock is registered under the Securities Exchange Act of 1934, as amended, and it files periodic reports with the U.S. Securities and Exchange Commission (“SEC”). For additional information about Journey Medical, visit www.journeymedicalcorp.com. Forward-Looking StatementsThis press release 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 press release, 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 development and regulatory approval of the DFD-29 product candidate 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. Company Contact:Jaclyn Jaffe (781) 652-4500ir@jmcderm.com Media Relations Contact:Tony Plohoros6 Degrees(908) 591-2839tplohoros@6degreespr.com JOURNEY MEDICAL CORPORATIONUnaudited Consolidated Balance Sheets($ in thousands except for share and per share amounts) June 30, December 31, 2024 2023 ASSETS Current assets Cash and cash equivalents$23,912 $27,439 Accounts receivable, net of reserves 10,465 15,222 Inventory 9,687 10,206 Prepaid expenses and other current assets 2,406 3,588 Total current assets 46,470 56,455 Intangible assets, net 18,658 20,287 Operating lease right-of-use asset, net 55 101 Other assets 6 6 Total assets$65,189 $76,849 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities Accounts payable$14,604 $18,149 Due to related party 260 195 Accrued expenses 15,972 20,350 Accrued interest 251 22 Income taxes payable - 53 Installment payments – licenses, short-term 3,000 3,000 Operating lease liability, short-term 59 99 Total current liabilities 34,146 41,868 Term loan, long-term, net of debt discount 19,748 14,622 Operating lease liability, long-term - 9 Total liabilities 53,894 56,499 Stockholders' equity Common stock, $.0001 par value, 50,000,000 shares authorized, 14,018,146 and 13,323,952 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively 1 1 Common stock - Class A, $.0001 par value, 50,000,000 shares authorized, 6,000,000 shares issued and outstanding as of June 30, 2024 and December 31, 2023 1 1 Additional paid-in capital 97,451 92,703 Accumulated deficit (86,158) (72,355)Total stockholders' equity 11,295 20,350 Total liabilities and stockholders' equity$65,189 $76,849 JOURNEY MEDICAL CORPORATIONUnaudited Consolidated Statements of Operations($ in thousands except for share and per share amounts) Three-Month Periods Ended Six-Month Periods Ended​June 30, June 30, 2024 2023 2024 2023 Revenue:​​​​​​​Product revenue, net$14,855 ​$16,961 $27,885 ​$29,126 Other revenue - 211 - 259 Total revenue 14,855 17,172 27,885 29,385 Operating expenses​​​​​​​Cost of goods sold – product revenue 6,541 ​ 7,767 13,357 14,216 Research and development 913 ​ 1,774 8,797 3,807 Selling, general and administrative 10,328 ​ 12,141 18,748 25,433 Loss on impairment of intangible assets - 3,143 - 3,143 Total operating expenses 17,782 ​ 24,825 40,902 ​ 46,599 Loss from operations (2,927)​ (7,653)​ (13,017)​ (17,214) Other expense (income) Interest income (161) (79) (378) (201)Interest expense 563 756 1,111 1,406 Foreign exchange transaction losses 32 33 53 80 Total other expense (income) 434 ​ 710 ​ 786 ​ 1,285 Loss before income taxes (3,361)​ (8,363)​ (13,803)​ (18,499) Income tax expense - - - - Net loss$(3,361)​$(8,363) $(13,803)​$(18,499) Net loss per common share: Basic and diluted$(0.17)​$(0.46) $(0.69)​$(1.03)Weighted average number of common shares: Basic and diluted 19,993,858 18,005,055 19,875,653 17,906,671 Use of Non-GAAP Measures: In addition to the GAAP financial measures as presented in our Form 10-Q that will be filed with the Securities and Exchange Commission (“SEC”), the Company has, in this press release, included certain non-GAAP measurements, including Adjusted EBITDA, Adjusted EBITDA per share basic and Adjusted EBITDA per share diluted. We define Adjusted EBITDA as net income (loss) excluding interest, taxes and depreciation, less certain other non-cash and infrequent items not considered to be normal, recurring operating expenses, including, share-based compensation expense, amortization and impairments of acquired intangible assets, severance, short-term research and development expense and foreign exchange transaction losses. In particular, we exclude the following matters for the reasons more fully described below: Share-Based Compensation Expense: We exclude share-based compensation from our adjusted financial results because share-based compensation expense, which is non-cash, fluctuates from period to period based on factors that are not within our control, such as our stock price on the dates share-based grants are issued.Non-core and Short-term Research and Development Expense: We exclude research and development costs incurred in connection with our DFD-29 product candidate, including the filing fee payment made to the FDA and contractual milestone payments, which is the only product in our portfolio not currently approved for marketing and sale, because we do not consider such costs to be normal, recurring operating expenses that are core to our long-term strategy. Instead, our long-term strategy is focused on the marketing and sale of our core FDA-approved dermatological products and the out licensing our intellectual property and related technologies.Amortization and impairments of Acquired Intangible assets: We exclude the impact of certain amounts recorded in connection with the acquisitions of intangible assets that are either non-cash or not normal, recurring operating expenses due to their nature, variability of amounts, and lack of predictability as to occurrence and/or timing. These amounts may include non-cash items such as the amortization impairments of acquired intangible assets. Adjusted EBITDA per share basic and Adjusted EBITDA per share diluted are determined by dividing the resulting Adjusted EBITDA by the number of shares outstanding on an actual and fully diluted basis. Management believes the use of these non-GAAP measures provide meaningful supplemental information regarding the Company’s performance because (i) it allows for greater transparency with respect to key measures used by management in its financial and operational decision-making, (ii) it excludes the impact of non-cash or, when specified, non-recurring items that are not directly attributable to the Company’s core operating performance and that may obscure trends in the Company’s core operating performance and (iii) it is used by institutional investors and the analyst community to help analyze the Company's results. However, Adjusted EBITDA, Adjusted EBITDA per share basic, Adjusted EBITDA per share diluted and any other non-GAAP financial measures should be considered as a supplement to, and not as a substitute for, or superior to, the corresponding measures calculated in accordance with GAAP. Further, non-GAAP financial measures used by the Company and the manner in which they are calculated may differ from the non-GAAP financial measures or the calculations of the same non-GAAP financial measures used by other companies, including the Company’s competitors. The table below provides a reconciliation from GAAP to non-GAAP measures: JOURNEY MEDICAL CORPORATIONReconciliation of GAAP to Non-GAAP Adjusted EBITDA(Dollars in thousands except for share and per share amounts) Three-Month Periods Ended Six-Month Periods Ended June 30 June 30 2024 2023 2024 2023 GAAP Net Loss$(3,361) $(8,363) $(13,803) $(18,499) EBITDA: Interest 402 677 733 1,205 Taxes - - - - Amortization of acquired intangible assets 814 1,069 1,629 2,138 EBITDA (2,145) (6,617) (11,441) (15,156) Non-GAAP Adjusted EBITDA: Non-Cash Components: Share-based compensation 1,674 873 3,080 1,519 Loss on impairment of intangible assets - 3,143 - 3,143 Non-core & Infrequent Components: Short-term R&D (includes one-time DFD-29 license and milestone payments) 742 1,744 8,482 3,743 Foreign exchange transaction losses 32 33 53 80 Severance 6 185 147 711 Non-GAAP Adjusted EBITDA$309 $(639) $321 $(5,960) Net income (loss) & Non-GAAP Adjusted EBITDA per common share: Basic GAAP Net Loss$(0.17) $(0.46) $(0.69) $(1.03)Non-GAAP Adjusted EBITDA$0.02 $(0.04) $0.02 $(0.33)Diluted GAAP Net Loss$(0.17) $(0.46) $(0.69) $(1.03)Non-GAAP Adjusted EBITDA$0.01 $(0.04) $0.01 $(0.33) Weighted average number of common shares: GAAP - Basic and Diluted 19,993,858 18,005,055 19,875,653 17,906,671 Non-GAAP - Basic 19,993,858 18,005,055 19,875,653 17,906,671 Non-GAAP - Diluted 24,298,007 18,005,055 24,203,162 17,906,671