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Journey Medical (DERM) - 2023 Q4 - Annual Results
2024-03-21 20:20
Revenue Performance - Total revenues for Journey Medical Corporation reached $79.2 million in 2023, a 7% increase from $73.7 million in 2022, primarily driven by a $19.0 million revenue from a licensing agreement with Maruho[1][3] - Total revenue for 2023 was $79,181,000, an increase of 7% compared to $73,669,000 in 2022[16] - Product revenue decreased to $59,662,000 in 2023 from $70,995,000 in 2022, representing a decline of 16%[16] - Other revenue significantly increased to $19,519,000 in 2023 from $2,674,000 in 2022, marking a growth of 629%[16] Cost Management - Operating cost savings of $15.6 million were achieved in 2023, exceeding the initial guidance of $12.0 million[1][5] - Total operating expenses decreased to $81,254,000 in 2023 from $101,186,000 in 2022, a reduction of 20%[16] - Research and development costs decreased to $7.5 million in 2023 from $10.9 million in 2022, attributed to lower clinical trial expenses for DFD-29[5] Financial Performance - The net loss for 2023 was $(3.9) million, or $(0.21) per share, significantly improved from a net loss of $(29.6) million, or $(1.69) per share in 2022[5] - Net loss for 2023 was $3,853,000, a significant improvement compared to a net loss of $29,628,000 in 2022[16] - Adjusted EBITDA for 2023 was $15.6 million, or $0.85 per share basic, compared to an Adjusted EBITDA of $(7.3) million in 2022[5] - Adjusted EBITDA for 2023 was $15,587,000, compared to a negative $7,283,000 in 2022, indicating a turnaround in operational performance[22] - Basic net loss per common share improved to $0.21 in 2023 from $1.69 in 2022[22] Assets and Liabilities - Total assets decreased to $76,849,000 in 2023 from $105,160,000 in 2022, a decline of 27%[14] - Total liabilities reduced to $56,499,000 in 2023 from $88,178,000 in 2022, a decrease of 36%[14] - Stockholders' equity increased to $20,350,000 in 2023 from $16,982,000 in 2022, reflecting a growth of 20%[14] Strategic Initiatives - The FDA accepted the New Drug Application for DFD-29 with a PDUFA goal date of November 4, 2024, which could position it as a leading treatment for rosacea[1][10] - Journey Medical entered into a $20.0 million credit facility with SWK Holdings Corporation to support general corporate purposes, including the potential launch of DFD-29[5] - The company expanded its market presence in Asia through a licensing agreement with Maruho, enhancing the reach of Qbrexza®[2][5]
Journey Medical Corporation Reports Full-Year 2023 Financial Results and Recent Corporate Highlights
Newsfilter· 2024-03-21 20:01
Company generated total revenues of $79.2 million for the full year ended December 31, 2023, a 7% increase from the $73.7 million reported in 2022 Achieved $15.6 million in operating cost savings in 2023, ahead of initial guidance of $12.0 million New Drug Application for rosacea treatment candidate DFD-29 accepted for U.S. FDA review; PDUFA goal date of November 4, 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., M ...
Journey Medical (DERM) Up as FDA Accepts Skin Disease Drug NDA
Zacks Investment Research· 2024-03-19 13:51
Journey Medical Corporation's (DERM) shares rose 10% on Mar 18, after the company announced that its new drug application (NDA) for its key pipeline candidate, DFD-29 capsules (40mg), to treat inflammatory lesions and erythema of rosacea in adults, has been accepted by the FDA for review.A decision from the regulatory body is expected on Nov 4, 2024.The NDA submission was based on positive data from Journey Medical’s two phase III studies (MVOR-1 and MVOR-2) of DFD-29 for treating rosacea. Both studies achi ...
Journey Medical Corporation Announces U.S. FDA Acceptance of New Drug Application for DFD-29 for the Treatment of Rosacea
Newsfilter· 2024-03-18 12:30
SCOTTSDALE, Ariz., March 18, 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, announced today that the FDA has accepted the Company's New Drug Application ("NDA") for DFD-29 (Minocycline Hydrochloride Modified Release Capsu ...
Journey Medical Corporation to Announce Year End 2023 Financial Results on March 21, 2024
Newsfilter· 2024-03-15 12:30
SCOTTSDALE, Ariz., March 15, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation ("Journey Medical" or the "Company") (NASDAQ:DERM), a commercial-stage pharmaceutical company that focuses on the selling and marketing of FDA-approved prescription pharmaceutical products for the treatment of dermatological conditions, today announced the Company will release its year end 2023 financial results after the U.S. financial markets close on Thursday, March 21, 2024. Journey Medical management will conduct a confer ...
Journey Medical Corporation to Announce Year End 2023 Financial Results on March 21, 2024
Globenewswire· 2024-03-15 12:30
SCOTTSDALE, Ariz., March 15, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation (“Journey Medical” or the “Company”) (Nasdaq: DERM), a commercial-stage pharmaceutical company that focuses on the selling and marketing of FDA-approved prescription pharmaceutical products for the treatment of dermatological conditions, today announced the Company will release its year end 2023 financial results after the U.S. financial markets close on Thursday, March 21, 2024. Journey Medical management will conduct a confe ...
Journey Medical Corporation to Participate in the 36th Annual ROTH Conference
Newsfilter· 2024-03-13 12:30
SCOTTSDALE, Ariz., March 13, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation ("Journey Medical") (NASDAQ:DERM), 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, today announced that management will participate in the 36th Annual ROTH Conference, which is being held March 17-19, 2024 in Dana Point, California. Claude Maraoui, President and Chief Executive Offi ...
Journey Medical Corporation Announces Presentation of Data from Phase 1 Clinical Trial Assessing the Impact of DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) on Microbial Flora of Healthy Adults at 2024 AAD Annual Meeting
Newsfilter· 2024-03-11 12:30
Clinical trial achieved all three primary objectives and subjects completed 16-week treatment with no significant safety issues Results indicate that DFD-29 can be safely used for up to 16 weeks with no detectable effects on microbiota in the skin, GI tract, or vagina New Drug Application for DFD-29 currently under review by U.S. FDA SCOTTSDALE, Ariz., March 11, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation (NASDAQ:DERM) ("Journey Medical"), a commercial-stage pharmaceutical company that primarily fo ...
Journey Medical (DERM) - 2023 Q3 - Quarterly Report
2023-11-12 16:00
PART I. FINANCIAL INFORMATION [Item 1. Condensed Consolidated Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) Unaudited Q3 2023 financials report $16.8 million net income, driven by a licensing payment, with decreased assets and going concern doubts [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Balance Sheet Summary (in thousands) | Balance Sheet Item | Sep 30, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $24,749 | $32,003 | | Accounts receivable, net | $7,989 | $28,208 | | Total current assets | $44,686 | $77,679 | | Total assets | $65,918 | $105,160 | | **Liabilities & Equity** | | | | Accounts payable | $28,164 | $36,570 | | Total current liabilities | $48,510 | $66,832 | | Total liabilities | $48,544 | $88,178 | | Total stockholders' equity | $17,374 | $16,982 | - Total assets decreased significantly from **$105.2 million** at the end of 2022 to **$65.9 million** as of September 30, 2023, driven by a reduction in cash, accounts receivable, and inventory[9](index=9&type=chunk) - Total liabilities were reduced from **$88.2 million** to **$48.5 million**, largely due to the repayment of a long-term term loan and a decrease in accounts payable[9](index=9&type=chunk) [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Q3 2023 vs Q3 2022 Statement of Operations (in thousands) | Metric | Q3 2023 | Q3 2022 | | :--- | :--- | :--- | | Total revenue | $34,539 | $16,116 | | Income (loss) from operations | $17,245 | $(9,492) | | Net income (loss) | $16,789 | $(10,080) | | Diluted EPS | $0.80 | $(0.57) | Nine Months 2023 vs 2022 Statement of Operations (in thousands) | Metric | Nine Months 2023 | Nine Months 2022 | | :--- | :--- | :--- | | Total revenue | $63,924 | $57,703 | | Income (loss) from operations | $31 | $(17,522) | | Net loss | $(1,710) | $(18,986) | | Diluted EPS | $(0.09) | $(1.09) | - The company reported a significant turnaround in Q3 2023 with a net income of **$16.8 million**, compared to a net loss of **$10.1 million** in Q3 2022, primarily driven by a large increase in 'Other revenue'[11](index=11&type=chunk) - For the nine months ended September 30, 2023, the company recorded a loss on impairment of intangible assets of **$3.1 million**, which was not present in the same period of 2022[11](index=11&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash Flow Summary for Nine-Month Periods (in thousands) | Cash Flow Activity | Nine Months 2023 | Nine Months 2022 | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | $21,760 | $(9,698) | | Net cash used in investing activities | $(5,000) | $(20,000) | | Net cash (used in) provided by financing activities | $(24,014) | $15,508 | | **Net change in cash** | **$(7,254)** | **$(14,190)** | - Cash from operating activities was a positive **$21.8 million** for the first nine months of 2023, a significant improvement from a **$9.7 million** use of cash in the same period of 2022[21](index=21&type=chunk) - Financing activities used **$24.0 million** in cash, primarily due to the repayment of a **$20.0 million** term loan and **$30.9 million** in line of credit repayments[21](index=21&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) - The company granted an exclusive license to Maruho Co., Ltd. for Qbrexza® in certain Asian territories, receiving a **$19.0 million** non-refundable upfront payment in August 2023[25](index=25&type=chunk)[79](index=79&type=chunk) - In July 2023, the company repaid its entire **$10.0 million** outstanding term loan under the EWB Facility and has no further debt obligations to EWB[26](index=26&type=chunk)[64](index=64&type=chunk) - Due to its financial condition, substantial doubt exists about the Company's ability to continue as a going concern for at least twelve months from the financial statement issuance date[29](index=29&type=chunk) - An intangible asset impairment charge of **$3.1 million** was recorded during the nine months ended September 30, 2023, related to the Ximino products due to revised lower financial outlook[42](index=42&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes Q3 2023 revenue increase and profitability to a $19.0 million licensing payment, with reduced operating expenses and ongoing liquidity challenges [Recent Corporate Highlights](index=25&type=section&id=Recent%20Corporate%20Highlights) - Entered into a new license agreement with Maruho for Qbrexza® in certain Asian territories, receiving a **$19.0 million** non-refundable upfront payment[97](index=97&type=chunk) - Paid off the entire **$10.0 million** outstanding balance on the EWB term loan in July 2023, leaving the company with no outstanding bank debt[98](index=98&type=chunk) - Announced positive topline data from two Phase 3 clinical trials for DFD-29 for rosacea, with plans to file an NDA with the FDA around the end of 2023[99](index=99&type=chunk) [Results of Operations](index=27&type=section&id=Results%20of%20Operations) Q3 2023 vs Q3 2022 Performance (in thousands) | Metric | Q3 2023 | Q3 2022 | Change % | | :--- | :--- | :--- | :--- | | Total revenue | $34,539 | $16,116 | 114% | | Total operating expenses | $17,294 | $25,608 | -32% | | Net income (loss) | $16,789 | $(10,080) | -267% | Nine Months 2023 vs 2022 Performance (in thousands) | Metric | Nine Months 2023 | Nine Months 2022 | Change % | | :--- | :--- | :--- | :--- | | Total revenue | $63,924 | $57,703 | 11% | | Total operating expenses | $63,893 | $75,225 | -15% | | Net loss | $(1,710) | $(18,986) | -91% | - Q3 2023 net product revenue decreased by **5%** YoY to **$15.3 million**, primarily due to lower Ximino sales as the product was wound down, with core products constituting **90%** of net product revenue[108](index=108&type=chunk)[109](index=109&type=chunk) - SG&A expenses decreased by **45%** in Q3 2023 and **25%** in the nine-month period, driven by cost reduction initiatives including a salesforce headcount reduction[115](index=115&type=chunk)[124](index=124&type=chunk) [Liquidity and Capital Resources](index=36&type=section&id=Liquidity%20and%20Capital%20Resources) - As of September 30, 2023, the company had **$24.7 million** in cash and cash equivalents, down from **$32.0 million** at December 31, 2022[127](index=127&type=chunk) - The company implemented a cost reduction initiative in late 2022, which included a salesforce headcount reduction and other cost cuts, resulting in a severance obligation of approximately **$0.7 million**[131](index=131&type=chunk) - Management states that substantial doubt exists about the company's ability to continue as a going concern for at least twelve months from the issuance date of the financial statements[132](index=132&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=38&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is a smaller reporting company and is not required to provide information for this item - As a smaller reporting company, Journey Medical Corporation is not required to provide quantitative and qualitative disclosures about market risk[140](index=140&type=chunk) [Item 4. Controls and Procedures](index=38&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded the company's disclosure controls and procedures were effective as of September 30, 2023, with no material changes to internal control over financial reporting - Management concluded that as of September 30, 2023, the company's disclosure controls and procedures were effective[141](index=141&type=chunk) - No changes in internal control over financial reporting occurred during the most recent quarter that materially affected, or are reasonably likely to materially affect, internal controls[142](index=142&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=39&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no pending legal proceedings, other than routine matters, expected to materially affect its financial condition, results of operations, or cash flows - There are no material legal proceedings pending against the company[145](index=145&type=chunk) [Item 1A. Risk Factors](index=39&type=section&id=Item%201A.%20Risk%20Factors) The primary risk factor is substantial doubt regarding the company's ability to continue as a going concern, necessitating additional funding which may not be available - A key risk factor is the substantial doubt about the company's ability to continue as a going concern for at least 12 months from the report's issuance date[147](index=147&type=chunk) - The company may need to raise additional capital through debt or equity financing, but there is no guarantee that financing will be available on acceptable terms[148](index=148&type=chunk) - If funding is not secured, the company may be required to significantly curtail, delay, or discontinue its DFD-29 research or development programs or the commercialization of other products[149](index=149&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=41&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During the reporting period, the company did not sell any equity securities in unregistered transactions, nor did it or its affiliates purchase any of its equity securities - The company has not sold any unregistered equity securities during the period covered by the report[150](index=150&type=chunk) [Item 6. Exhibits](index=42&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including corporate governance documents, new license agreements with Maruho Co., Ltd., and officer certifications - Exhibits filed include the License Agreement and the Second Amended and Restated License Agreement with Maruho Co., Ltd., both dated August 31, 2023[155](index=155&type=chunk)
Journey Medical (DERM) - 2023 Q3 - Earnings Call Transcript
2023-11-12 05:34
Journey Medical Corporation (NASDAQ:DERM) Q3 2023 Earnings Conference Call November 7, 2023 4:30 PM ET Company Participants Jaclyn Jaffe - Senior Director, Corporate Operations Claude Maraoui - Co-Founder, President and CEO Joseph Benesch - Interim Chief Financial Officer Dr. Srinivas Sidgiddi - Vice President, Research and Development Ramsey Allous - General Counsel and Corporate Secretary Conference Call Participants Scott Henry - ROTH Capital Andy Fleszar - B. Riley Operator Ladies and gentlemen, thank y ...