Verrica Pharmaceuticals(VRCA)
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Verrica Pharmaceuticals(VRCA) - 2025 Q3 - Quarterly Report
2025-11-14 21:34
Product Development and Approval - YCANTH (VP-102) was approved by the FDA in July 2023 for the treatment of molluscum contagiosum in patients aged two years and older [131]. - The company launched YCANTH (VP-102) commercially in August 2023, supported by a specialized sales team of 36 representatives [132]. - The company plans to expand its sales force to 50 representatives by 2026 and launch YCANTH Rx in Q4 2025 to streamline prescription processes [133]. - The Phase 3 program for YCANTH (VP-102) targeting common warts is expected to begin dosing the first patient in Q4 2025 [134]. - The company received positive feedback from the European Medicines Agency for filing a Marketing Authorization Application for YCANTH (VP-102) in the EU [135]. - VP-315 is being developed for basal cell carcinoma, with two Phase 3 studies planned, each involving approximately 100 subjects [136]. Financial Performance - Total revenue for the three months ended September 30, 2025, was $14.3 million, a decrease of $1.8 million from $16.1 million in the same period of 2024 [160]. - Product revenue, net increased to $3.6 million for the three months ended September 30, 2025, compared to a negative $1.9 million in 2024, primarily due to increased deliveries of YCANTH [161]. - License and collaboration revenue rose significantly to $10.7 million for the three months ended September 30, 2025, from $0.1 million in 2024, driven by a $10.0 million milestone payment from Torii [162]. - For the nine months ended September 30, 2025, total revenue was $30.5 million, an increase of $23.3 million from $7.2 million in 2024 [172]. - Product revenue, net for the nine months ended September 30, 2025, was $11.6 million, up from $6.3 million in 2024, attributed to increased deliveries of YCANTH [173]. - License and collaboration revenue for the nine months ended September 30, 2025, reached $18.9 million, compared to $1.0 million in 2024, mainly from milestone payments from Torii [174]. Expenses and Losses - Selling, general and administrative expenses decreased to $9.4 million for the three months ended September 30, 2025, down from $16.1 million in 2024, reflecting lower commercial activity costs [165]. - Research and development expenses were $2.2 million for the three months ended September 30, 2025, a slight decrease from $2.4 million in 2024 [166]. - Selling, general and administrative expenses for the nine months ended September 30, 2025, were $27.1 million, down from $48.9 million in 2024, due to reduced commercial activities [177]. - Research and development expenses for the nine months ended September 30, 2025, totaled $6.3 million, a decrease from $10.7 million in 2024, primarily due to lower clinical trial costs [179]. - Interest expense decreased to $6.4 million for the nine months ended September 30, 2025, down from $7.1 million in the same period of 2024, due to a lower outstanding principal balance under the Credit Agreement [182]. - The company has incurred significant operating losses and expects to continue doing so for the foreseeable future, raising substantial doubt about its ability to continue as a going concern [195][197]. Cash and Liquidity - As of September 30, 2025, the company had cash and cash equivalents of $21.1 million, with an accumulated deficit of $316.8 million [141]. - The company is obligated to maintain a liquidity of at least $10.0 million under its Credit Agreement [139]. - The company entered into a Credit Agreement on July 26, 2023, borrowing $50.0 million, with net proceeds of approximately $44.1 million after fees [186]. - The company is obligated to maintain a liquidity of at least $10.0 million under the Credit Agreement, with a waiver for certain financial statement qualifications until the end of 2025 [187]. - Net cash used in operating activities was $13.0 million for the nine months ended September 30, 2025, compared to $44.9 million in the same period of 2024, indicating a significant reduction in cash outflow [189][190]. - Net cash used in financing activities was $12.2 million for the nine months ended September 30, 2025, primarily due to debt repayment related to the Credit Agreement [193]. - The company may receive up to $25.0 million from the exercise of Series A Warrants, which could provide additional liquidity in 2025 [195].
Verrica Pharmaceuticals(VRCA) - 2025 Q3 - Quarterly Results
2025-11-14 21:25
Financial Performance - Verrica reported $14.3 million in total revenue for Q3 2025, with $3.6 million from YCANTH® and $10.7 million from license and collaboration revenue[1]. - Total revenue for the nine months ended September 30, 2025, reached $30.485 million, up from $7.222 million in the same period of 2024, indicating a growth of approximately 322%[23]. - Product revenue for the three months ended September 30, 2025, was $3.607 million, compared to a loss of $1.865 million in the same period of 2024, representing a significant increase[21]. - For Q3 2025, net loss was $0.3 million, or $0.03 per share, compared to a net loss of $22.9 million, or $4.88 per share, for the same period in 2024[12]. - The net loss for the three months ended September 30, 2025, was $274 thousand, a substantial improvement from a net loss of $22.860 million in the same period of 2024[21]. - Non-GAAP adjusted net income for the three months ended September 30, 2025, was $1.194 million, compared to a non-GAAP adjusted net loss of $20.180 million in the same period of 2024[27]. Revenue Sources - License and collaboration revenue for the nine months ended September 30, 2025, was $18.9 million, compared to $1.0 million for the same period in 2024[13]. - The company received a $10 million cash milestone payment for the approval of YCANTH for molluscum in Japan[1]. Expenses - Selling, general and administrative expenses decreased to $9.4 million in Q3 2025 from $16.1 million in Q3 2024, a reduction of $5.6 million[12]. - Research and development expenses were $2.2 million for Q3 2025, compared to $2.4 million for the same period in 2024[12]. - Total operating expenses for the nine months ended September 30, 2025, were $35.478 million, a decrease from $61.731 million in the same period of 2024, reflecting a reduction of approximately 43%[23]. Product Development - YCANTH® (VP-102) is the first FDA-approved product for treating molluscum contagiosum, affecting approximately 6 million people in the U.S., primarily children[15]. - The company plans to launch YCANTH Rx, a new non-dispensing pharmacy option, in Q4 2025[10]. - The company plans to launch YCANTH Rx in the fourth quarter of 2025, with expectations for future commercial growth[19]. - The FDA provided positive feedback on the study design for a Phase 3 program for VP-315 in basal cell carcinoma, with a primary endpoint of complete clearance assessed at week 14[10]. - VP-315, a potential first-in-class oncolytic chemotherapeutic peptide immunotherapy, is being developed for non-melanoma skin cancers, with a focus on basal cell and squamous cell carcinomas[16]. Cash Position - As of September 30, 2025, Verrica had $21.1 million in cash and cash equivalents[12]. - The company’s cash and cash equivalents decreased to $21.097 million as of September 30, 2025, down from $46.329 million at the end of 2024[25]. Stockholders' Equity - The company reported a total stockholders' deficit of $17.040 million as of September 30, 2025, compared to a deficit of $9.860 million at the end of 2024[25]. Product Dispensation - The company dispensed 37,642 applicator units of YCANTH for the nine months ending September 30, 2025, representing a 120% increase compared to 17,119 units in the prior year[3].
Verrica Pharmaceuticals Reports Third Quarter 2025 Financial Results
Globenewswire· 2025-11-14 21:05
Core Insights - Verrica Pharmaceuticals Inc. reported significant progress in its commercial and clinical activities, particularly with its product YCANTH for molluscum contagiosum, and highlighted a strong foundation for future growth [2][4]. Financial Performance - The company reported $14.3 million in total revenue for Q3 2025, which includes $3.6 million from YCANTH and $10.7 million from license and collaboration revenue [4][21]. - For the nine months ending September 30, 2025, product revenue was $11.6 million, up from $6.3 million in the same period in 2024 [11][15]. - The net loss for Q3 2025 was $0.3 million, or $0.03 per share, compared to a net loss of $22.9 million, or $4.88 per share, for Q3 2024 [12][21]. Product and Pipeline Developments - YCANTH dispensed 37,642 applicator units in the first nine months of 2025, a 120% increase from 17,119 units in the prior year [2][11]. - The company initiated a global Phase 3 clinical program for YCANTH in common warts, with first patient enrollment expected in the U.S. by the end of 2025 [9][12]. - Positive feedback was received from the FDA regarding the study design for a Phase 3 program for VP-315, an oncology asset targeting basal cell carcinoma [4][12]. Regulatory Milestones - The approval of YCANTH for molluscum in Japan triggered a $10 million milestone payment to Verrica [12][15]. - The European Medicines Agency provided a pathway for YCANTH's registration in Europe without the need for additional Phase 3 studies [4][12]. Strategic Partnerships - Verrica's collaboration with Torii Pharmaceutical includes a 50/50 cost-sharing agreement for the global Phase 3 program, with Torii funding the first $40 million of trial costs [12][15]. - The company is exploring potential partnerships and non-dilutive financing discussions to support further development and commercialization of its late-stage programs [2][12].
Verrica Pharmaceuticals Presents New Data on VP-315 from its Phase 2 Clinical Trial in Basal Cell Carcinoma at the 40th Society for Immunotherapy of Cancer Annual Meeting
Globenewswire· 2025-11-10 13:00
Core Insights - Verrica Pharmaceuticals has presented new data from its Phase 2 study of VP-315, an oncolytic peptide immunotherapy, showing its potential to reprogram the tumor microenvironment and enhance immune response in basal cell carcinoma patients [1][2][3] Study Overview - VP-315 is administered intratumorally and aims to induce immunogenic tumor cell death while promoting anti-tumor immune responses [3] - The Phase 2 study involved 82 subjects with 92 tumors, receiving daily injections of 8 mg VP-315 for 2-3 consecutive days [3] Clinical Outcomes - VP-315 demonstrated a 51% complete histologic clearance rate and an overall 97% objective response rate [5] - The treatment was well-tolerated, with no serious adverse events reported [5] - Patients experienced an 86% overall reduction in tumor size, with a 71% reduction in those with residual carcinomas [5] Immune Microenvironment Analysis - The treatment resulted in significant increases in CD3+, CD3+/CD4+, and CD3+/CD8+ T cell densities, indicating enhanced immune activation [11] - There was also an increase in B-cell infiltration, suggesting activation of humoral immunity [11] - The findings indicate a shift from an immunosuppressive to an anti-tumor state in the tumor microenvironment [6][11] Market Potential - The company views VP-315 as a potential first-in-class, non-surgical immunotherapy for basal cell carcinoma, addressing a significant unmet need in dermatologic oncology [2][8] - The annual incidence of basal cell carcinoma in the U.S. is approximately 3.6 million, highlighting the market opportunity for new treatment options [8]
Halper Sadeh LLC Encourages Luminar Technologies, Inc. Shareholders to Contact the Firm to Discuss Their Rights
Businesswire· 2025-10-24 15:10
Core Viewpoint - Halper Sadeh LLC is investigating potential breaches of fiduciary duties by certain officers and directors of Luminar Technologies, Inc., urging shareholders to contact the firm to discuss their rights and possible legal actions [1][2]. Group 1: Shareholder Rights and Legal Options - Long-term shareholders of Luminar may seek corporate governance reforms, the return of funds to the company, court-approved financial incentive awards, or other relief and benefits [2][3]. - Shareholder involvement is emphasized as a means to improve company policies, practices, and oversight mechanisms, ultimately enhancing shareholder value [3]. Group 2: Firm's Background and Services - Halper Sadeh LLC represents investors globally who have experienced securities fraud and corporate misconduct, having successfully implemented corporate reforms and recovered millions for defrauded investors [4].
Halper Sadeh LLC Encourages Verrica Pharmaceuticals, Inc. Shareholders to Contact the Firm to Discuss Their Rights
Businesswire· 2025-10-24 15:00
Core Viewpoint - Halper Sadeh LLC is investigating potential breaches of fiduciary duties by certain officers and directors of Verrica Pharmaceuticals, Inc. (NASDAQ: VRCA), urging shareholders to contact the firm to discuss their rights and possible legal actions [1][2]. Group 1: Shareholder Rights and Legal Options - Long-term shareholders of Verrica may seek corporate governance reforms, the return of funds to the company, court-approved financial incentive awards, or other relief and benefits [2][3]. - Shareholder involvement is emphasized as a means to improve company policies, practices, and oversight mechanisms, ultimately enhancing shareholder value [3]. Group 2: Firm's Background and Services - Halper Sadeh LLC represents investors globally who have experienced securities fraud and corporate misconduct, having successfully implemented corporate reforms and recovered millions for defrauded investors [4].
Morning Market Movers: ATMV, NEUP, BOF, RYOJ See Big Swings
RTTNews· 2025-10-21 11:45
Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - AlphaVest Acquisition Corp (ATMV) is up 71% at $14.24 [3] - BranchOut Food Inc. (BOF) is up 44% at $3.04 [3] - rYojbaba Co., Ltd. (RYOJ) is up 35% at $5.14 [3] - GSI Technology, Inc. (GSIT) is up 25% at $16.24 [3] - Jowell Global Ltd. (JWEL) is up 18% at $2.02 [3] - General Motors Company (GM) is up 9% at $63.68 [3] - Crown Holdings, Inc. (CCK) is up 8% at $103.00 [3] - Spero Therapeutics, Inc. (SPRO) is up 8% at $2.49 [3] - Sunrun Inc. (RUN) is up 6% at $21.90 [3] - Foxx Development Holdings Inc. (FOXX) is up 5% at $4.50 [3] Premarket Losers - Neuphoria Therapeutics Inc. (NEUP) is down 66% at $5.19 [4] - New Era Energy & Digital, Inc. (NUAI) is down 9% at $5.09 [4] - Odyssey Marine Exploration, Inc. (OMEX) is down 8% at $3.28 [4] - Carbon Revolution Public Limited Company (CREV) is down 7% at $4.86 [4] - Coeur Mining, Inc. (CDE) is down 7% at $20.38 [4] - Hecla Mining Company (HL) is down 6% at $13.50 [4] - Verrica Pharmaceuticals Inc. (VRCA) is down 6% at $4.12 [4] - Sensei Biotherapeutics, Inc. (SNSE) is down 5% at $10.06 [4] - Whitehawk Therapeutics, Inc. (WHWK) is down 5% at $2.52 [4] - Greenidge Generation Holdings Inc. (GREE) is down 5% at $2.07 [4]
Verrica Pharmaceuticals Receives Positive Feedback from the European Medicines Agency (EMA) Supporting a Clear Regulatory Path Forward to File for Approval of YCANTH® in the European Union
Globenewswire· 2025-10-20 20:05
Core Insights - The European Medicines Agency (EMA) has concluded that prior Phase 3 studies in the U.S. and Japan are sufficient to support a Marketing Authorization Application (MAA) for YCANTH in the EU, with no additional Phase 3 studies required [1][2] - Verrica Pharmaceuticals is initiating activities to support the regulatory submission, which could be filed as early as Q4 2026 [1][2] Company Overview - Verrica Pharmaceuticals Inc. is focused on developing dermatology therapeutics, specifically medications for skin diseases that require medical interventions [4] - YCANTH (VP-102) is a proprietary drug-device combination product that treats molluscum contagiosum, a highly contagious skin disease affecting approximately six million people in the U.S., primarily children [3][4] - YCANTH is the first and only healthcare professional-administered product approved by the FDA for treating molluscum in patients aged two years and older [3][4] Market Opportunity - The European market for molluscum represents a significant unmet need for millions of potential patients, providing a key catalyst for Verrica to explore strategic opportunities for YCANTH [2] - Approximately 225 million lives are eligible to receive YCANTH covered by insurance, with commercially insured patients paying $25 per treatment visit for up to two applicators [3] Clinical Development - The CHMP provided positive feedback on the design of previously completed Phase 3 studies, including study duration, choice of endpoints, and patient population [5] - The clinical safety data package and the adequacy of nonclinical studies were also discussed to support the MAA filing [5]
Verrica Pharmaceuticals to Present New Data on VP-315 from its Phase 2 Trial in Basal Cell Carcinoma (BCC) at the 40th Society for Immunotherapy of Cancer (SITC) Annual Meeting
Globenewswire· 2025-10-07 20:05
Core Insights - Verrica Pharmaceuticals Inc. is set to present its investigational therapy VP-315 for basal cell carcinoma at the SITC 40th Annual Meeting in November 2025 [1][3][4] Presentation Details - The oral presentation will occur during the Rapid Oral Abstract Session on November 5, 2025, featuring an exploratory analysis of a phase 2 multicenter study on local immune activation post VP-315 treatment [3][4] - The abstract for the presentation will be available on the SITC website on November 4, 2025 [2] About VP-315 - VP-315 is a potential first-in-class oncolytic chemotherapeutic peptide immunotherapy designed to induce immunogenic cell death in tumors, providing a non-surgical treatment option for skin cancer patients [5] - The therapy is based on research into "host defense peptides" and aims to target non-metastatic melanoma and non-metastatic Merkel cell carcinoma, with a focus on basal cell and squamous cell carcinomas [5] About Verrica Pharmaceuticals Inc. - Verrica is a dermatology therapeutics company that has developed YCANTH (VP-102), the first FDA-approved treatment for molluscum contagiosum, affecting approximately 6 million people in the U.S. [6][7] - The company has entered a worldwide license agreement with Lytix Biopharma AS to develop and commercialize VP-315 for non-melanoma skin cancers [7]
Verrica Pharmaceuticals Announces That Development Partner, Torii Pharmaceutical, Receives Approval for YCANTH® (TO-208) in Japan for the Treatment of Molluscum Contagiosum
Globenewswire· 2025-09-19 12:00
Core Insights - Approval of YCANTH® in Japan addresses a significant unmet need for patients with molluscum contagiosum, triggering a $10 million cash milestone payment to Verrica [1][2] - Verrica retains global rights to YCANTH for all indications outside of Japan, indicating strong market potential for the product [1][2] - The company is optimistic about future approvals for YCANTH globally and is preparing for a Phase 3 program for treating common warts [2] Company Overview - Verrica Pharmaceuticals Inc. is focused on developing medications for skin diseases requiring medical interventions, with YCANTH being the first FDA-approved treatment for molluscum contagiosum [4][5] - The company has a partnership with Torii Pharmaceutical Co. Ltd., which has recently received regulatory approval for YCANTH in Japan [2][4] - YCANTH is a proprietary drug-device combination product that allows for precise topical dosing, targeting a common skin disease affecting approximately six million people in the U.S. [3][4] Financial Implications - The approval of YCANTH in Japan will provide Verrica with a one-time $10 million milestone payment, enhancing its financial position and supporting U.S. commercial activities [2] - Approximately 225 million lives are eligible for YCANTH coverage, with commercially insured patients paying only $25 per treatment visit [3] Clinical Development - The approval was based on positive results from a Phase 3 trial in Japan, which demonstrated the efficacy and safety of TO-208 compared to placebo [2] - The company is also working on expanding the use of YCANTH for treating common warts, with a Phase 3 program expected to begin by the end of 2025 [2]