Minocycline Hydrochloride

— Innovative approach accelerates new product development and testing — SILVER SPRING, Md., May 28, 2025 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix technologies, today announced the publication of a peer-reviewed article describing the first validated method for measuring antibiotic release from a biologic envelope. The novel method demonstrates in vitro elution that closely replicates preclinical studies, offering an approach to characterize drug release while enabling faster, lower cost development and testing of the EluPro portfolio. The article appears in the current issue of Dissolution Technologies . Drug release testing is a critical element of product development and regulatory evaluation for combination products, which integrate drugs and devices. The U.S. Food and Drug Administration (FDA) considers drug elution performance essential for establishing manufacturing consistency and control. Elutia’s new method delivers reliable data in 30 hours—for results comparable to 14-day in vivo protocols—allowing for faster iteration and lower resource usage. It captures the biphasic release profile of minocycline and rifampin, including both the immediate and sustained release phases. “This work reflects Elutia’s leadership in developing high-performing drug-eluting biomatrices grounded in rigorous science,” said Dana Yoo, Ph.D., Vice President of Development at Elutia. “Having a robust, validated in vitro method supports the product lifecycle for EluPro—the first and only FDA-cleared antibiotic-eluting bioenvelope—and accelerates the development of future drug-eluting biologic matrices in our pipeline.” EluPro, an antibiotic-eluting bioenvelope designed for use with cardiac implantable electronic devices (CIEDs) and neurostimulators, was commercially launched in the United States in January 2025 . Its unique combination of trusted antibiotics and a soft, regenerative biomatrix supports healing while naturally conforming to pocket anatomy and the cardiac implant, addressing device-related complications. The antibiotic-eluting disc delivers consistent and reproducible drug release, providing local drug delivery without compromising the biomatrix’s regenerative properties. To learn more, visit www.elutia.com/products/elupro/ . About Elutia Elutia develops and commercializes drug-eluting biomatrix products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Elutia’s mission is humanizing medicine so patients can thrive without compromise. For more information, visit www.Elutia.com . Forward Looking Statements This press release contains “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. Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” “promise” or similar references to future periods. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including any statements and information concerning the market reception of EluPro, including the timing and anticipated success thereof, and the development, testing and anticipated success of the EluPro portfolio. These forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to us. Such beliefs and assumptions may or may not prove to be correct. Additionally, such forward-looking statements are subject to a number of known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in the forward-looking statements, including, but not limited to the following: our ability to successfully commercialize, market and sell our EluPro product; our ability to continue as a going concern; our ability to achieve or sustain profitability; the risk of product liability claims and our ability to obtain or maintain adequate product liability insurance; our ability to defend against the various lawsuits and claims related to our recalled FiberCel and other viable bone matrix products and avoid a material adverse financial consequence from those lawsuits and claims; our ability to prevail in lawsuits and claims seeking indemnity, contribution and insurance coverage for FiberCel and other viable bone matrix product liabilities; the continued and future acceptance of our products by the medical community; our ability to enhance our products, expand our product indications and develop, acquire and commercialize additional product offerings; our dependence on our commercial partners and independent sales agents to generate a substantial portion of our net sales; our dependence on a limited number of third-party suppliers and manufacturers, which, in certain cases are exclusive suppliers for products essential to our business; our ability to successfully realize the anticipated benefits of the November 2023 sale of our Orthobiologics business; physician awareness of the distinctive characteristics, benefits, safety, clinical efficacy and cost-effectiveness of our products; our ability to compete against other companies, most of which have longer operating histories, more established products and/or greater resources than we do; pricing pressure as a result of cost-containment efforts of our customers, purchasing groups, third-party payors and governmental organizations that could adversely affect our sales and profitability; our ability to obtain regulatory approval or other marketing authorizations by the FDA and comparable foreign authorities for our products and product candidates; our ability to obtain, maintain and adequately protect our intellectual property rights; and other important factors which can be found in the “Risk Factors” section of Elutia’s public filings with the Securities and Exchange Commission (“SEC”), including Elutia’s Annual Report on Form 10-K for the year ended December 31, 2024, as such factors may be updated from time to time in Elutia’s other filings with the SEC, including Elutia’s Quarterly Reports on Form 10-Q, accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Elutia’s website at https://investors.elutia.com. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. Any forward-looking statement made by Elutia in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, Elutia expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Investors: Matt Steinberg FINN Partners matt.steinberg@finnpartners.com This press release was published by a CLEAR® Verified individual. Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. 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Revenue for the First Quarter Ended March 31, 2025 was $13.1 million Emrosi™ (40 mg Minocycline Hydrochloride Modified-Release Capsules) Commercial Launch Off to a Strong Start, Initial Prescriptions Filled in Late March 2025 Phase 3 Clinical Trial Results for Emrosi Published in JAMA Dermatology Emrosi Now Included in Updated National Rosacea Society Treatment Algorithms Company to Hold Conference Call Today at 4:30 p.m. ET SCOTTSDALE, Ariz., May 14, 2025 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical” or “the Company”, “we”, or “our”), a commercial-stage pharmaceutical company that primarily focuses on selling and marketing 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 first quarter ended March 31, 2025. “The first quarter of 2025 was highly productive, as our in-line dermatology products continue to perform and the launch of Emrosi™, our best-in-class oral rosacea treatment, is off to a strong start,” said Claude Maraoui, Journey Medical’s Co-Founder, President and Chief Executive Officer. “The Emrosi launch is enjoying high visibility among dermatology prescribers with momentum from our exhibition booth at the American Academy of Dermatology (AAD) conference in late March, the recent publication of Emrosi’s statistically superior Phase 3 clinical trial results over Oracea® and placebo in JAMA Dermatology, and the promotional efforts from our experienced and highly effective dermatology salesforce. Emrosi was also recently incorporated into the National Rosacea Society’s Rosacea Treatment Algorithms, and payer coverage of the product continues to increase.” Mr. Maraoui continued, “Financially, we remain in a strong position with $21.1 million in cash as of March 31, an improvement in our gross margin, and overall operating spend down year-over-year. We believe that our first quarter financial results and launch progress with Emrosi demonstrate that we are executing on our strategic objectives, and that 2025 will be a transformational year for the Company as we drive the business to sustainable positive EBITDA and profitability.” Financial Results: Total net product revenues of $13.1 million for the first quarter of 2025 were consistent with $13.0 million of net product revenues for the first quarter of 2024. The first quarter of 2025 includes $2.1 million of incremental net product revenue related to the U.S. commercial launch of Emrosi. The Company’s gross margin(1) increased to 64% for the first quarter of 2025, from 54% in the prior period due to lower overall product cost of goods related to product sales mix and non-recurring charges in the prior year. Research and development costs were nil in the first quarter of 2025, compared to $7.9 million in the first quarter of 2024. The first quarter of 2024 includes Emrosi pre-approval project expenses, milestones and fees. Selling, general and administrative expenses increased by $2.1 million for the three-month period ended March 31, 2025, from $8.4 million for the three-month period ended March 31, 2024. The increase is primarily due to the incremental operational activities related to the launch and commercialization of Emrosi. The Company’s net loss was $4.1 million, or $(0.18) per share basic and diluted, for the first quarter of 2025, compared to a net loss of $10.4 million, or $(0.53) per share basic and diluted, for the first quarter of 2024. At March 31, 2025, the Company had $21.1 million in cash and cash equivalents as compared to $20.3 million in cash and cash equivalents at December 31, 2024. Recent Corporate Highlights: In April 2025, Journey Medical appointed Ramsey Alloush as its Chief Operating Officer. Mr. Alloush joined the Company as General Counsel in 2020. At the end of March 2025, Journey Medical announced initial distribution to pharmacies and first prescriptions filled. Full commercial launch began on April 7, 2025. In March 2025, the Journal of the American Medical Association - Dermatology published the Phase 3 clinical trial results of Emrosi for the treatment of rosacea, highlighting that Emrosi achieved the co-primary and all secondary endpoints in two Phase 3 trials and demonstrated statistical superiority against both Oracea(2) and placebo with no significant safety issues when administered once daily for 16 weeks. In March 2025, the National Rosacea Society published its updated Rosacea Treatment Algorithms to include low-dose oral minocycline (referenced in the brand index as Emrosi™). The Updated Treatment Algorithms can be accessed at https://www.rosacea.org/physicians/rosacea-treatment-algorithms. Information on such website is not a part of this release. In February 2025, Journey Medical hosted a conference call and webcast to discuss its U.S. commercial launch plan for Emrosi (40 mg Minocycline Hydrochloride Modified-Release Capsules) for the treatment of rosacea. A replay of the webcast is available on the IR calendar page of the Journey Medical website, and can be accessed at https://ir.journeymedicalcorp.com/new-events/ir-calendar. Information on such website is not a part of this release. Conference Call and Webcast InformationJourney Medical management will conduct a conference call and audio webcast on May 14, 2025, 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/10199519/ff117b0a70. 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. (1) We define gross margin as net product revenue less cost of goods sold divided by net product revenue.(2) Oracea® is a registered trademark of Galderma Holdings, S.A. Société Anonyme. 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 eight branded FDA-approved prescription drugs 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 commercialization of our recently approved product, Emrosi™, 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, 2024, 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 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, inventory step-ups from the purchases of intangibles assets and products, 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 principally in connection with Emrosi, which was the only product in our portfolio not currently approved for marketing and sale during the prior-year reporting period, 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 and amortization of step-ups of acquisition accounting adjustments to inventories. 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: The Company’s non-GAAP results in the table above reflect an Adjusted EBITDA loss of $0.9 million, or $(0.04) per share basic and diluted, for the first quarter of 2025, compared to Adjusted EBITDA income of $11,000, or $0.00 per share basic and diluted, for the first quarter of 2024. Adjusted EBITDA, Adjusted EBITDA per share basic and Adjusted EBITDA per share diluted are non-GAAP financial measures, each of which are reconciled to the most directly comparable financial measures calculated in accordance with GAAP above. Released May 14, 2025