Fortress Biotech(FBIO)
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Fortress Biotech(FBIO) - 2025 Q1 - Quarterly Report
2025-05-15 20:34
Financial Performance - For the three months ended March 31, 2025, net revenue was $13.1 million, compared to $13.0 million for the same period in 2024, reflecting a slight increase in revenue [187]. - For Q1 2025, Mustang reported a net revenue of $13.1 million, a 1% increase from $13.0 million in Q1 2024, including $2.0 million from the U.S. launch of Emrosi [206][207]. - The net loss attributable to Fortress decreased by 31% to $10.6 million in Q1 2025 from $15.4 million in Q1 2024 [206]. - Total other income (expense) decreased by $0.1 million, or 3%, from an expense of $2.5 million for the quarter ended March 31, 2024, to an expense of $2.4 million for the quarter ended March 31, 2025 [219]. - Net cash used in operating activities decreased by $5.8 million from $25.4 million for the three months ended March 31, 2024, to $19.6 million for the same period in 2025 [238]. - Net cash provided by financing activities was $27.9 million for the three months ended March 31, 2024, compared to $52.1 million for the same period in 2025, an increase of $24.3 million [241]. Research and Development - CAEL-101 is currently undergoing two global Phase 3 pivotal studies for AL amyloidosis, with topline data expected in the second half of 2025 [195]. - The FDA accepted the NDA for CUTX-101 (copper histidinate for Menkes disease) for priority review, with a target action date of September 30, 2025 [195]. - Triplex, a cytomegalovirus vaccine, is currently in a Phase 2 clinical trial with topline data anticipated in the third quarter of 2025 [190]. - The company is exploring a trial for MB-109 to treat patients with IL13Rα2+ recurrent GBM, potentially starting in Q1 2026 [195]. - Mustang is planning a proof-of-concept Phase 1 clinical trial for MB-106 in autoimmune diseases, potentially starting in Q1 2026 [203]. - Research and development expenses dropped by 84% to $3.9 million in Q1 2025, down from $24.8 million in Q1 2024, largely due to workforce reductions and the closure of the MB-106 clinical trial [212]. Expenses and Cost Management - Operating expenses decreased by 29% to $35.5 million in Q1 2025 from $49.6 million in Q1 2024, primarily due to an 84% reduction in research and development expenses [206]. - Selling, general and administrative expenses increased by 43% to $25.7 million in Q1 2025, driven by a $4.9 million increase at Checkpoint and a $2.1 million increase at Journey [215]. - Cost of goods sold decreased by 20% to $4.8 million in Q1 2025 from $6.0 million in Q1 2024, attributed to a change in product sales mix [208]. - Amortization of acquired intangible assets rose by 31% to $1.1 million in Q1 2025, influenced by the addition of the Emrosi asset [209]. Corporate Actions and Agreements - Checkpoint Therapeutics, Inc. entered into an agreement to be acquired by Sun Pharmaceutical Industries, Inc. for $4.10 per share in cash, with a contingent value right of up to $0.70 per share upon achieving EU approval [190]. - Fortress has established partnerships with leading institutions and companies, including AstraZeneca and Dr. Reddy's Laboratories, to enhance product development [183]. - Mustang executed a 1-for-50 reverse stock split in January 2025 to comply with Nasdaq listing requirements [203]. - Mustang exited its manufacturing facility lease in Worcester, Massachusetts, selling assets to AbbVie for $1.0 million in February 2025 [203]. Cash and Securities - As of March 31, 2025, the company had cash and cash equivalents of $91.3 million, with $19.5 million related to Fortress and private subsidiaries, $33.0 million to Checkpoint, $14.2 million to Mustang, $21.1 million to Journey, and $3.5 million to Avenue [222]. - The company reported an accumulated deficit of $751.5 million as of March 31, 2025, primarily due to R&D expenses and administrative costs [221]. - Net cash provided by investing activities increased by $1.2 million, attributed to Mustang's proceeds from the sale of held-for-sale assets [240]. - The company issued and sold approximately 0.5 million shares at an average price of $1.94 per share for gross proceeds of approximately $1.0 million under its at-the-market offering program during the three months ended March 31, 2025 [226]. - Journey issued and sold approximately 0.8 million shares of common stock for gross proceeds of $4.1 million under its at-the-market offering agreement during the same period [229]. - As of March 31, 2025, approximately $65.7 million of securities remain available for sale through Checkpoint's registration statement [230]. - Mustang closed on an equity offering in February 2025, raising approximately $6.8 million in net proceeds after deducting fees and expenses [234]. Regulatory and Compliance - Fortress is classified as a "smaller reporting company," with market value criteria affecting its reporting obligations [202]. - The company is classified as a "smaller reporting company" and is not required to provide certain market risk disclosures [244]. - There were no material changes in contractual obligations and commitments during the three months ended March 31, 2025 [243].
Fortress Biotech(FBIO) - 2025 Q1 - Quarterly Results
2025-05-15 20:10
Financial Performance - Fortress Biotech reported consolidated net product revenue of $13.1 million for Q1 2025, compared to $13.0 million in Q1 2024, reflecting a slight increase[15]. - Journey Medical's net product revenues for Q1 2025 were $13.1 million, slightly up from $13.0 million in Q1 2024[9]. - Product revenue for the three months ended March 31, 2025, was $13,139,000, a slight increase from $13,030,000 in the same period of 2024, reflecting a growth of 0.8%[21]. - Fortress reported a consolidated net loss attributable to common stockholders of $(12.7) million, or $(0.48) per share, for Q1 2025, an improvement from a net loss of $(17.9) million, or $(1.04) per share, in Q1 2024[15]. - Net loss for the three months ended March 31, 2025, was $24,691,000, compared to a net loss of $39,023,000 in Q1 2024, indicating an improvement of 36.7%[21]. - Net loss attributable to common stockholders decreased to $12,715,000 in Q1 2025 from $17,860,000 in Q1 2024, a reduction of 29.1%[21]. Cash and Assets - Fortress' consolidated cash and cash equivalents increased by $34.0 million to $91.3 million as of March 31, 2025, compared to $57.3 million at the end of 2024[15]. - Cash and cash equivalents increased to $91,339,000 as of March 31, 2025, up from $57,263,000 at December 31, 2024, representing a growth of 59.5%[20]. - Total assets increased to $178,071,000 as of March 31, 2025, up from $144,223,000 at December 31, 2024, representing a growth of 23.5%[20]. - Total liabilities remained relatively stable at $145,585,000 as of March 31, 2025, compared to $145,867,000 at December 31, 2024, showing a slight decrease of 0.2%[20]. - The accumulated deficit increased to $(751,451,000) as of March 31, 2025, from $(740,867,000) at December 31, 2024, reflecting a change of 1.6%[20]. Expenses - Fortress' consolidated research and development expenses decreased to $3.9 million in Q1 2025 from $24.8 million in Q1 2024[15]. - Total operating expenses decreased to $35,456,000 in Q1 2025 from $49,596,000 in Q1 2024, a reduction of 28.5%[21]. - Research and development expenses significantly decreased to $3,938,000 in Q1 2025 from $24,839,000 in Q1 2024, a decline of 84.2%[21]. - Consolidated selling, general and administrative costs rose to $25.7 million in Q1 2025, compared to $17.9 million in Q1 2024[15]. Strategic Developments - The FDA accepted the New Drug Application for CUTX-101 with a PDUFA goal date of September 30, 2025, which may also result in a Priority Review Voucher[2]. - The commercial launch of Emrosi™ for treating inflammatory lesions of rosacea began in March 2025, with initial prescriptions filled[9]. - Fortress entered into a strategic collaboration with Partex NV to evaluate biopharmaceutical compounds using artificial intelligence for potential acquisition or licensing[15]. - The company expects to receive approximately $28 million at closing from the acquisition of Checkpoint Therapeutics by Sun Pharma, along with future potential royalties and a contingent value right payment[2]. Shareholder Information - The weighted average common shares outstanding increased to 26,450,218 in Q1 2025 from 17,151,945 in Q1 2024, an increase of 54.3%[21].
Fortress Biotech Reports First Quarter 2025 Financial Results and Recent Corporate Highlights
Globenewswire· 2025-05-15 20:05
Core Insights - Fortress Biotech, Inc. has initiated the commercial launch of Emrosi™ for treating inflammatory lesions of rosacea in adults, following FDA approval in November 2024 [4] - The company reported a net loss of $(12.7) million, or $(0.48) per share, for Q1 2025, an improvement from a net loss of $(17.9) million, or $(1.04) per share, in Q1 2024 [12][18] - Fortress' subsidiary Checkpoint Therapeutics is set to be acquired by Sun Pharma, with expected upfront cash payment of approximately $28 million and potential future royalties [3][2] Financial Results - Fortress' consolidated cash and cash equivalents increased to $91.3 million as of March 31, 2025, up from $57.3 million at the end of 2024, marking a $34 million increase [12][14] - Consolidated net product revenue for Q1 2025 was $13.1 million, slightly up from $13.0 million in Q1 2024 [9][18] - Research and development expenses for Q1 2025 totaled $3.9 million, a significant decrease from $24.8 million in Q1 2024 [12][18] Regulatory Updates - The FDA accepted the New Drug Application for CUTX-101 for Menkes disease, with a PDUFA goal date of September 30, 2025 [2][8] - UNLOXCYT, an anti-PD-L1 antibody developed by Checkpoint, was approved by the FDA in December 2024 for treating patients with metastatic or locally advanced cutaneous squamous cell carcinoma [8] Commercial Product Updates - Emrosi was launched by Journey Medical Corporation, with initial prescriptions filled at the end of March 2025 [4][18] - Full results from two Phase 3 clinical trials evaluating Emrosi were published, demonstrating its efficacy and safety for treating moderate-to-severe papulopustular rosacea [18] Corporate Highlights - Fortress has a robust pipeline with multiple late-stage programs and newly approved products, positioning the company for continued revenue growth [2] - The acquisition of Checkpoint by Sun Pharma is expected to enhance patient access to Checkpoint's products and create significant monetization opportunities for Fortress [3][2]
Fortress Biotech to Participate in the H.C. Wainwright 1st Annual Royalty Company Virtual Conference
Globenewswire· 2025-05-07 12:00
Core Viewpoint - Fortress Biotech, Inc. is actively participating in the H.C. Wainwright Annual Royalty Company Virtual Conference, highlighting its commitment to enhancing shareholder value through innovative biopharmaceutical strategies [1]. Company Overview - Fortress Biotech is focused on acquiring and advancing biopharmaceutical assets to enhance long-term shareholder value through product revenue, equity holdings, and dividend and royalty revenue [2]. - The company has eight marketed prescription pharmaceutical products and over 20 programs in development across various therapeutic areas, including oncology, dermatology, and rare diseases [2]. - Fortress has established partnerships with leading academic research institutions and biopharmaceutical companies, such as AstraZeneca and Fred Hutchinson Cancer Center, to maximize the potential of its product opportunities [2]. Conference Participation - Lindsay A. Rosenwald, M.D., the Chairman, President, and CEO of Fortress, will participate in a fireside chat and a panel presentation at the conference, indicating the company's engagement with industry discussions [1][3]. - The conference sessions include a fireside chat scheduled from 2:00 p.m. to 2:30 p.m. ET and a panel presentation from 5:00 p.m. to 6:00 p.m. ET [3].
Fortress Biotech (FBIO) Reports Q4 Loss, Lags Revenue Estimates
ZACKS· 2025-03-31 22:50
Company Performance - Fortress Biotech reported a quarterly loss of $0.26 per share, significantly better than the Zacks Consensus Estimate of a loss of $0.79, and an improvement from a loss of $0.53 per share a year ago, resulting in an earnings surprise of 67.09% [1] - The company posted revenues of $15.12 million for the quarter ended December 2024, missing the Zacks Consensus Estimate by 12.58%, and down from $19.95 million in the same quarter last year [2] - Fortress Biotech has surpassed consensus EPS estimates three times over the last four quarters but has not beaten consensus revenue estimates during the same period [2] Stock Performance - Fortress Biotech shares have declined approximately 20.5% since the beginning of the year, compared to a decline of 5.1% for the S&P 500 [3] - The current Zacks Rank for Fortress Biotech is 3 (Hold), indicating that the shares are expected to perform in line with the market in the near future [6] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is $1.47 on revenues of $11.84 million, while for the current fiscal year, the estimate is -$1.13 on revenues of $155.67 million [7] - The estimate revisions trend for Fortress Biotech is mixed, and changes in these estimates could occur following the recent earnings report [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Fortress Biotech belongs, is currently ranked in the top 27% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8]
Fortress Biotech(FBIO) - 2024 Q4 - Annual Report
2025-03-31 20:15
Financial Performance - Total net revenue for the years ended December 31, 2024 and 2023 was $57.7 million and $84.5 million, respectively, with net product revenue from Journey's commercial portfolio at $55.1 million and $59.7 million[394]. - For the year ended December 31, 2024, the company generated net revenue of $57.7 million, a decrease of $26.8 million or 32% from $84.5 million in 2023[428]. - Product revenue decreased by $4.5 million or 8% to $55.1 million, primarily due to higher managed care rebate costs and lower unit volumes from legacy products[429]. - The company reported a net loss of $120.9 million for 2024, a reduction of $33.3 million or 22% compared to a net loss of $154.2 million in 2023[425]. - Total operating expenses decreased by $58.8 million or 26% to $168.1 million in 2024 from $226.9 million in 2023[425]. - The cost of goods sold decreased by $2.0 million or 9% to $20.9 million in 2024, attributed to lower royalties and a decrease in sales[430]. - Collaboration revenue fell by $3.7 million or 71% to $1.5 million in 2024, compared to $5.2 million in 2023[426]. - The total cash decrease for the year ended December 31, 2024, was $24.6 million, compared to a decrease of $97.6 million in 2023, reflecting a significant improvement of $73.0 million[486]. Research and Development - Research and development expenses were approximately $56.6 million in 2024, down $45.1 million or 44% from $101.7 million in 2023[434]. - The company expects research and development costs to decrease in 2025[439]. - Research and development expenses for licenses acquired dropped by $4.1 million or 94% to $252,000 in 2024, due to the absence of comparable transactions[440]. - Stock-based compensation expense included in R&D increased by $3.9 million or 120% to $7.1 million in 2024, primarily due to performance-based vesting at Checkpoint[437]. Equity and Financing Activities - Fortress raised total net proceeds of approximately $21.1 million through equity offerings throughout 2024[412]. - Checkpoint raised total net proceeds of approximately $32.8 million through equity offerings and warrant exercises throughout 2024[412]. - Mustang raised total net proceeds of approximately $11.2 million through equity offerings and warrant exercises throughout 2024[412]. - Avenue raised total net proceeds of approximately $9.8 million through equity offerings and warrant exercises throughout 2024[412]. - Fortress entered into a new $50 million term loan with Oaktree Capital Management, borrowing $35 million initially and having the option to draw an additional $15 million[406]. - Fortress entered into a $50.0 million senior secured credit agreement in July 2024, borrowing $35.0 million initially, with a maturity date of July 25, 2027[481]. - Journey entered into a Credit Agreement with SWK Funding LLC for a term loan facility of up to $25 million, with $15 million drawn on December 27, 2023, and the remaining $10 million drawn upon FDA approval of Emrosi[485]. Regulatory Approvals and Product Developments - Checkpoint received FDA approval for UNLOXCYT (cosibelimab-ipdl) for the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma on December 13, 2024[394]. - Emrosi (Minocycline Hydrochloride Extended-Release Capsules) was approved by the FDA in November 2024 for the treatment of inflammatory lesions of rosacea, with a launch planned for March 2025[394]. - Cyprium announced that the FDA accepted the NDA for CUTX-101 for priority review, with a target action date of September 30, 2025[398]. - Mustang's MB-101 CAR T-cell therapy showed a 50% stable disease or better rate in high-grade glioma patients, with two complete responses lasting over 66 months[402]. - Updated data for MB-106 indicated a 90% overall response rate in patients with Waldenstrom macroglobulinemia, including three complete responses[402]. Cash Flow and Liquidity - Net cash used in operating activities decreased by $48.0 million from 2023 to 2024, primarily due to a decrease in net loss of $33.3 million and a one-time recovery payment of $4.6 million[487]. - Net cash used by investing activities increased from $2.1 million in 2023 to $15.0 million in 2024, due to a $15 million milestone payment triggered by FDA approval of Emrosi[488]. - Net cash provided by financing activities increased by $37.9 million from 2023 to 2024, driven by proceeds from long-term debt of $33.7 million and common stock issuance of $17.4 million[490]. - The company reported a net cash outflow from operating activities of $80.2 million for the year ended December 31, 2024, compared to $128.2 million in 2023[491]. Stock and Shareholder Actions - Fortress announced a pause in dividend payments on its 9.375% Series A Preferred Stock, deferring approximately $0.7 million in cash dividends each month[406]. - Mustang executed a 1-for-50 reverse stock split to comply with Nasdaq listing requirements[406]. - Avenue's common stock began trading under the symbol "ATXI" on the OTC Markets system after receiving a notice of suspension from Nasdaq[406]. - Journey issued approximately 1.6 million shares of common stock at an average price of $5.19 per share for net proceeds of $7.9 million in 2024[461]. - Checkpoint received approximately $9.2 million from the exercise of Series B warrants to purchase 3,256,269 shares of common stock in November 2024[463]. - Checkpoint closed a registered direct offering in July 2024, issuing 1,230,000 shares at $2.05 per share, raising approximately $11.0 million in net proceeds[464]. - Mustang sold approximately $4.4 million of securities under its 2021 S-3 registration statement in 2024, prior to its expiration[466]. - Avenue raised approximately $4.5 million from the exercise of existing warrants in January 2024, after deducting fees[477]. Other Significant Events - Journey received a $19.0 million upfront payment for the exclusive license of certain rights relating to Qbrexza in Asia, included in total net revenue for 2023[394]. - Urica entered into a transaction with Crystalys Therapeutics, transferring rights to dotinurad and receiving 35% equity in Crystalys along with a 3% royalty on future net sales[402]. - Fortress's Board of Directors approved a workforce reduction of approximately 81% to reduce costs and preserve capital[412]. - Mustang recorded an asset impairment of $3.7 million in 2024, a 17% increase from the $3.1 million impairment in 2023[449]. - Journey recorded a loss recovery benefit of $4.6 million related to a cybersecurity incident, received in cash in December 2024[448]. - Total other expense decreased by $1.1 million, or 10%, from $11.3 million in 2023 to $10.2 million in 2024[452]. - As of December 31, 2024, the company had cash and cash equivalents of $57.3 million, with $20.9 million related to Fortress and private subsidiaries[454].
Fortress Biotech(FBIO) - 2024 Q4 - Annual Results
2025-03-31 20:10
Financial Performance - Fortress Biotech reported consolidated net revenue of $57.7 million for the full year ended December 31, 2024, down from $84.5 million in 2023, with dermatology product revenue decreasing from $59.7 million to $55.1 million[14]. - Fortress Biotech reported a net revenue of $57.675 million for the year ended December 31, 2024, a decrease of 31.7% compared to $84.513 million in 2023[19]. - Product revenue, net, was $55.134 million in 2024, down from $59.662 million in 2023, reflecting a decline of 7.5%[19]. - The net loss attributable to common stockholders was $(55.9) million, or $(2.69) per share, for 2024, an improvement from a net loss of $(68.7) million, or $(8.47) per share, in 2023[14]. - The net loss attributable to common stockholders for 2024 was $55.890 million, compared to a net loss of $68.669 million in 2023, showing an improvement of 18.5%[19]. - Fortress Biotech's net loss per common share attributable to common stockholders was $(2.69) in 2024, compared to $(8.47) in 2023, indicating a significant reduction in loss per share[19]. Expenses - Consolidated research and development expenses totaled $56.9 million for 2024, a significant decrease from $106.1 million in 2023[14]. - Research and development expenses were $56.629 million in 2024, down 44.4% from $101.747 million in 2023[19]. - Consolidated selling, general and administrative costs were $87.7 million for 2024, compared to $91.0 million in 2023[14]. - Total operating expenses decreased to $168.054 million in 2024 from $226.855 million in 2023, a reduction of 26%[19]. - The company reported a loss from operations of $110.379 million in 2024, an improvement from a loss of $142.342 million in 2023[19]. Cash and Assets - Fortress' cash and cash equivalents totaled $57.3 million as of December 31, 2024, down from $80.9 million at the end of 2023[14]. - Fortress Biotech's cash and cash equivalents decreased to $57.263 million as of December 31, 2024, from $80.927 million in 2023, a decline of 29%[18]. - Fortress Biotech's total assets decreased to $144.223 million in 2024 from $167.526 million in 2023, a decline of 13.9%[18]. - The company’s accumulated deficit increased to $(740.867) million in 2024 from $(694.870) million in 2023[18]. Strategic Developments - Fortress' subsidiary Checkpoint Therapeutics is set to be acquired by Sun Pharma, with Fortress expecting to receive approximately $28 million at closing and a 2.5% royalty on net sales of UNLOXCYT[2]. - The FDA accepted the New Drug Application for CUTX-101, with a PDUFA goal date of September 30, 2025[2]. - The commercial launch of Emrosi for treating inflammatory lesions of rosacea is underway, with initial prescriptions filled[2]. - Fortress raised total net proceeds of approximately $21.1 million through equity offerings in 2024[10]. - Fortress entered into a strategic collaboration with Partex NV to evaluate biopharmaceutical compounds using artificial intelligence for potential acquisition or licensing[10].
Fortress Biotech Reports 2024 Financial Results and Recent Corporate Highlights
Globenewswire· 2025-03-31 20:05
Core Insights - Fortress Biotech, Inc. announced significant developments including FDA approvals for Emrosi™ and UNLOXCYT™, and the acceptance of a New Drug Application for CUTX-101, indicating a transformative fourth quarter for the company [2][7] - The acquisition of Checkpoint Therapeutics by Sun Pharma is expected to enhance patient access to UNLOXCYT and provide Fortress with approximately $28 million at closing, along with a 2.5% royalty on net sales [2][3] - Fortress aims to leverage its pipeline of late clinical-stage candidates and recently approved products to drive revenue growth and shareholder value [2][10] Recent Corporate Highlights - Fortress' subsidiary Checkpoint Therapeutics is set to be acquired by Sun Pharma, with Fortress holding approximately 6.9 million shares of Checkpoint and eligible for a 2.5% royalty on future sales of UNLOXCYT [3] - The acquisition agreement includes an upfront cash payment of $4.10 per share for Checkpoint stockholders, plus a contingent value right potentially worth an additional $0.70 [3] - Fortress raised approximately $21.1 million through equity offerings in 2024, while Checkpoint raised about $32.8 million during the same period [11] Regulatory Updates - The FDA approved Emrosi (Minocycline Hydrochloride Extended-Release Capsules, 40mg) for treating inflammatory lesions of rosacea in November 2024, with commercial launch initiated in March 2025 [7][2] - UNLOXCYT was approved by the FDA in December 2024 for treating metastatic or locally advanced cutaneous squamous cell carcinoma [7] - The FDA accepted the New Drug Application for CUTX-101 for priority review, with a PDUFA goal date set for September 30, 2025 [7][2] Clinical Updates - Phase 3 clinical trials for Emrosi demonstrated its efficacy, safety, and tolerability in treating moderate-to-severe papulopustular rosacea, with results published in the Journal of the American Medical Association - Dermatology [7] - Clinical data for UNLOXCYT presented at the European Society for Medical Oncology Congress 2024 showed improved response rates over time [7] - A Phase 2 clinical trial for Triplex, a cytomegalovirus vaccine, commenced in January 2025, targeting patients undergoing hematopoietic stem cell transplantation [7] Financial Results - Fortress reported consolidated net revenue of $57.7 million for the year ended December 31, 2024, down from $84.5 million in 2023, with product revenue from dermatology products totaling $55.1 million [10][17] - Consolidated research and development expenses decreased to $56.9 million in 2024 from $106.1 million in 2023 [10][17] - The net loss attributable to common stockholders was $(55.9) million, or $(2.69) per share, for the year ended December 31, 2024, compared to a net loss of $(68.7) million, or $(8.47) per share, in 2023 [10][17]
Fortress Biotech(FBIO) - 2024 Q4 - Earnings Call Transcript
2025-03-26 23:39
Financial Data and Key Metrics Changes - Journey Medical reported annual revenue of $56 million in 2024, a decrease from $79 million in 2023, primarily due to higher rebate costs and lower unit volumes from legacy products [10][26] - Total net product revenue for 2024 was $55.1 million, down from $59.7 million in 2023 [26] - The net loss for 2024 was $14.7 million, or $0.72 per share, compared to a net loss of $3.9 million, or $0.21 per share in 2023 [30] - Non-GAAP adjusted EBITDA for 2024 was positive $800,000, down from $15.6 million in 2023 [31][32] - Cash and cash equivalents as of December 31, 2024, were $20.3 million, down from $27.4 million at the end of 2023 [32] Business Line Data and Key Metrics Changes - Research and development expenses increased by $2.3 million to $9.9 million in 2024, driven by non-recurring payments related to Emrosi's NDA filing [28][29] - Selling, general and administrative (SG&A) expenses decreased by $3.7 million to $40.2 million in 2024, attributed to expense optimization efforts [30] Market Data and Key Metrics Changes - Emrosi is entering a treatment category valued at over $1 billion, with expectations for significant operating leverage as it gains market traction [13][14] - As of early 2025, approximately 20% of commercial lives and 4% of Medicare lives have coverage for Emrosi, with expectations for substantial increases throughout the year [18][19] Company Strategy and Development Direction - The company is focused on the launch of Emrosi, which is expected to be a major growth driver, with peak annual sales estimated at $200 million in the U.S. and $100 million internationally [34] - Journey Medical plans to continue attending and presenting at dermatology-focused medical congresses throughout 2025 to promote Emrosi [23][35] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the launch of Emrosi and its potential to transform the business, highlighting the positive reception from dermatologists at recent conferences [15][17] - The company anticipates a ramp-up in payer coverage and prescription demand over the next 12 to 18 months [40][41] Other Important Information - Journey Medical completed a total of $22 million in FDA filing fees and milestone payments related to Emrosi in 2024 [11] - The company has received a $1 million milestone payment following regulatory approval for Amzeeq in China [27] Q&A Session Summary Question: What should be expected for payer coverage by the end of 2025? - Management expects peak commercial coverage to take 12 to 18 months, with ongoing efforts to increase covered lives [38][40] Question: How important was the erythema data to KOLs at AAD? - The head-to-head performance data was of significant interest, while erythema data was not a primary focus [42][44] Question: Thoughts on 2025 guidance? - Guidance for 2025 will be provided later in the year after assessing initial Emrosi prescription demand [52][54] Question: How has the reimbursement environment been? - Early indications show that around 20% coverage is on target, with prescriptions starting to come in [56][57] Question: Will Q1 report meaningful revenues from Emrosi? - Minimal revenues are expected in Q1, with more significant contributions anticipated in Q2 [59] Question: How is pricing across the legacy portfolio expected to change? - Pricing for legacy brands is expected to hold steady, with some erosion in volume due to competition [80][81] Question: What are the main bottlenecks for the Emrosi launch? - Supply and formulary coverage are key areas of focus, with ample supply already secured [86][88] Question: Will there be any pricing moves by competitors post-launch? - No significant pricing movements from competitors have been observed since the launch [104]
Partex and Fortress Biotech Announce Strategic Collaboration to Accelerate Asset Identification and Evaluation Using Proprietary AI Platform
Globenewswire· 2025-03-17 12:55
Core Insights - Partex NV and Fortress Biotech, Inc. have announced a strategic collaboration to utilize artificial intelligence in identifying and evaluating biopharmaceutical compounds for potential acquisition or licensing by Fortress [1][4]. Company Overview - Partex is an AI-driven biopharmaceutical company focused on revolutionizing drug discovery and development, aiming to accelerate the identification and commercialization of breakthrough therapies [5]. - Fortress Biotech is an innovative biopharmaceutical company that focuses on acquiring and advancing assets to enhance long-term shareholder value through product revenue, equity holdings, and dividend and royalty revenue [6]. Collaboration Details - Partex will deploy its proprietary AI-based drug discovery platform, which provides diverse recommendations on alternative targets and helps evaluate compounds across various therapeutic areas [2]. - The collaboration aims to leverage the strengths of both companies, combining Fortress's expertise in clinical development with Partex's advanced AI platform to enhance the efficiency of identifying and evaluating biopharmaceutical assets [3][4]. - The partnership is expected to expedite the search and evaluation process for differentiated assets, utilizing AI to maximize potential opportunities [4]. Business Development Focus - Fortress is focused on expanding its portfolio and business development opportunities, with a robust late-stage pipeline and the recent launch of two approved medicines [4]. - The collaboration with Partex is seen as a means to scale operations more efficiently and cost-effectively, enhancing long-term value for shareholders [4].