Arcutis Biotherapeutics(ARQT)
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Arcutis Biotherapeutics (NasdaqGS:ARQT) 2025 Earnings Call Presentation
2025-10-28 14:30
3rd Quarter 2025 Financial Results & Investor Day October 28, 2025 Legal Disclaimers This presentation and the accompanying oral presentation contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended. Forward- looking statements include all statements other than statements of historical fact contained in this presentation, including information concerning our current and future financ ...
Wayfair, Qorvo, Celestica, United Parcel Service, Regeneron Pharmaceuticals And Other Big Stocks Moving Higher On Tuesday - Arcutis Biotherapeutics (NASDAQ:ARQT), Agilysys (NASDAQ:AGYS)

Benzinga· 2025-10-28 14:14
Core Insights - U.S. stocks experienced an upward trend, with the Dow Jones index increasing by approximately 200 points on Tuesday [1] Company Performance - Wayfair Inc reported third-quarter earnings of 70 cents per share, surpassing the analyst consensus estimate of 43 cents per share, and quarterly sales of $3.117 billion, exceeding the consensus estimate of $3.014 billion, leading to a 21.8% surge in shares to $105.40 [1] - Arcutis Biotherapeutics Inc shares rose by 23.5% to $24.26 following strong quarterly results [4] - Terawulf Inc gained 20% to $16.37 after reporting preliminary third-quarter 2025 financial results [4] - Cameco Corp shares surged 19.3% to $103.33 due to a partnership with Brookfield and the U.S. government for new Westinghouse nuclear reactors [4] - Agilysys Inc saw a 16.3% increase to $133.86 after reporting upbeat quarterly earnings [4] - Leggett & Platt Inc shares surged 13.6% to $10.46 following strong quarterly sales [4] - Nanobiotix SA – ADR gained 15.5% to $17.42 [4] - Skyworks Solutions Inc shares increased by 14.2% to $86.59 after announcing a merger agreement with Qorvo [4] - Qorvo Inc shares jumped 11.8% to $103.00 in light of the merger agreement with Skyworks [4] - PayPal Holdings Inc rose 11.1% to $78.05 after announcing a deal with OpenAI and releasing better-than-expected third-quarter financial results [4] - Confluent Inc reported better-than-expected earnings for the third quarter, leading to a 10.9% rise in shares to $24.50 [4] - ATI Inc gained 10.4% to $101.28 after reporting better-than-expected quarterly financial results [4] - Celestica Inc shares increased by 8.7% to $328.00 after better-than-expected quarterly results and raised FY2025 EPS and sales guidance [4] - United Parcel Service Inc rose 8.1% to $96.42 after reporting better-than-expected third-quarter results and issuing above-estimate fourth-quarter sales guidance [4] - Regeneron Pharmaceuticals Inc shares surged 7.6% to $629.57 following better-than-expected quarterly results [4] - Check Point Software Technologies Ltd gained 7% to $205.28 after reporting better-than-expected quarterly results [4] - Nucor Corp shares increased by 6.1% to $152.88 after posting better-than-expected earnings for the third quarter [4]
Arcutis Biotherapeutics(ARQT) - 2025 Q3 - Quarterly Report
2025-10-28 12:38
Product Development and Approvals - ZORYVE cream 0.3% was launched in August 2022 and received FDA approval for expanded indications down to 6 years of age in October 2023[122]. - ZORYVE foam for seborrheic dermatitis was approved by the FDA in December 2023 and became commercially available in January 2024[122]. - A co-promotion agreement with Kowa Pharmaceuticals was established in July 2024 to market ZORYVE in the U.S. until at least July 2029[124]. - The company halted further development of ARQ-255 after completing a Phase 1b study in mid-2025[125]. - The company plans to commence a Phase 1 study of ARQ-234 in the first quarter of 2026 after submitting an IND application in July 2025[126]. Financial Performance - The company reported net losses of $33.5 million and $129.3 million for the nine months ended September 30, 2025 and 2024, respectively, with an accumulated deficit of $1,155.5 million as of September 30, 2025[127]. - Product revenue for ZORYVE cream 0.3% increased by $8.5 million, or 38%, to $30.5 million for the three months ended September 30, 2025, compared to the same period in 2024[146]. - ZORYVE foam revenue surged by $29.5 million, or 146%, reaching $49.8 million for the three months ended September 30, 2025, driven by higher demand and new product launches[148]. - Total product revenue for the three months ended September 30, 2025, was $99.2 million, a 122% increase from $44.8 million in the same period of 2024[146]. - For the nine months ended September 30, 2025, total product revenue reached $244.6 million, a 152% increase from $97.2 million in the same period of 2024[157]. - ZORYVE cream 0.15% revenue increased by $41.3 million, or 1686%, for the nine months ended September 30, 2025, driven by its commercial launch in July 2024[160]. Expenses and Cash Flow - The company expects to incur significant commercialization expenses related to ZORYVE and product candidates, while focusing on clinical development for ARQ-234 and ZORYVE label expansions[128]. - Selling, general and administrative expenses are anticipated to increase as the company continues to commercialize ZORYVE and support operations[140]. - Research and development expenses slightly increased by $0.1 million, or 1%, totaling $19.6 million for the three months ended September 30, 2025[152]. - Selling, general and administrative expenses rose by $3.6 million, or 6%, to $63.5 million for the three months ended September 30, 2025, primarily due to commercialization efforts[153]. - The company expects research and development expenses to increase in future periods due to ongoing development and clinical studies related to ARQ-234 and ZORYVE life cycle management[165]. - For the nine months ended September 30, 2025, net cash used in operating activities was $31.8 million, compared to $111.4 million for the same period in 2024[185][187]. - During the nine months ended September 30, 2025, net cash provided by investing activities was $3.9 million, primarily from maturities of marketable securities totaling $172.4 million[188]. Debt and Interest Rates - As of September 30, 2025, the aggregate principal amount outstanding under the Loan Agreement was $100.0 million[174]. - The company made a 2024 Partial Prepayment of $100.0 million, reducing the outstanding principal under the Loan Agreement and incurring a prepayment penalty of $1.0 million[175]. - The applicable interest rate after the 2024 Partial Prepayment is 5.95% plus the greater of 2.50% or the one-month Secured Overnight Financing Rate (SOFR)[176]. - The company has $100.0 million outstanding under its Loan Agreement, with a floating interest rate of 5.95% plus the greater of 2.50% or the one-month SOFR[195]. - A 100 basis point increase in interest rates would result in approximately $1.0 million of additional annual interest expense for the company[195]. - The maturity date of the Loan Agreement is August 1, 2029, following the 2024 Partial Prepayment[175]. Cash and Securities - As of September 30, 2025, the company had cash, cash equivalents, restricted cash, and marketable securities totaling $191.4 million[127]. - As of September 30, 2025, the company had cash and cash equivalents of $47.1 million, restricted cash of $0.3 million, and marketable securities totaling $143.9 million[194]. Foreign Currency and Risk Management - The company is exposed to foreign currency exchange risk due to its Canadian subsidiary operating in Canadian dollars, with cash balances of $6.4 million in Canadian dollars as of September 30, 2025[196]. - The company does not currently engage in hedging transactions for interest rate or foreign currency risks[195][196]. - A hypothetical 10% change in foreign exchange rates would not have a material impact on the company's condensed consolidated financial statements[196]. - An immediate change in interest rates of 100 basis points would not materially affect the fair value of the company's investment portfolio due to its low risk profile[194].
Arcutis Biotherapeutics(ARQT) - 2025 Q3 - Quarterly Results
2025-10-28 12:32
Financial Performance - Q3 2025 net product revenue for ZORYVE was $99.2 million, a 122% increase compared to Q3 2024, and a 22% increase compared to Q2 2025[4] - ZORYVE net product sales for Q3 2025 were $99.2 million, driven by increasing demand and improved gross-to-net pricing[8] - Product revenue for Q3 2025 reached $99.219 million, a significant increase from $44.755 million in Q3 2024, representing a growth of 121%[27] - Total revenues for the nine months ended September 2025 were $246.569 million, compared to $125.182 million for the same period in 2024, marking a 97% increase[27] - Net income for Q3 2025 was $7.4 million, compared to a net loss of $41.5 million in Q3 2024[16] - Net income for Q3 2025 was $7.410 million, a recovery from a net loss of $41.537 million in Q3 2024[27] - Basic earnings per share for Q3 2025 were $0.06, compared to a loss of $0.33 per share in Q3 2024[27] Expenses - Research and development expenses for Q3 2025 were $19.6 million, consistent with the previous year[14] - Selling, general, and administrative expenses for Q3 2025 were $62.4 million, an increase from $58.8 million in Q3 2024[15] - Operating expenses for Q3 2025 totaled $90.693 million, up from $83.821 million in Q3 2024, reflecting an increase of 8%[27] - Research and development expenses for the nine months ended September 2025 were $56.600 million, down from $61.940 million in the same period of 2024, a decrease of 9%[27] - Selling, general, and administrative expenses increased to $62.404 million in Q3 2025 from $58.817 million in Q3 2024, an increase of 4%[27] - Interest expense for the nine months ended September 2025 was $9.082 million, down from $21.617 million in the same period of 2024, a reduction of 58%[27] - The company reported other income of $2.035 million in Q3 2025, compared to $4.182 million in Q3 2024, a decrease of 51%[27] Product Development - ZORYVE cream 0.05% received FDA approval for treating atopic dermatitis in children as young as 2 years old in October 2025[4] - The company provided initial 2026 full year net product sales guidance of $455–$470 million[17] - ZORYVE is projected to achieve peak sales of $2.6–$3.5 billion annually across current and potential future indications[7] - The company is preparing to initiate a Phase 1 study of ARQ-234, a potential biologic treatment for atopic dermatitis[9] Cash and Securities - Cash, cash equivalents, and marketable securities totaled $191.4 million as of September 30, 2025, down from $228.6 million at the end of 2024[16] - The weighted-average diluted shares used in computing earnings per share for Q3 2025 were 132,885 thousand, unchanged from Q3 2024[27]
Arcutis Outlines Strategy for Driving Sustainable Growth and Announces Third Quarter 2025 Financial Results
Globenewswire· 2025-10-28 12:30
Core Insights - Arcutis Biotherapeutics, Inc. is focused on sustainable growth through its innovative dermatology products, particularly the ZORYVE franchise, which has shown significant commercial momentum [2][5][6] Financial Performance - For Q3 2025, Arcutis reported net product revenue of $99.2 million, marking a 122% increase year-over-year and a 22% increase sequentially from Q2 2025 [5][7][9] - The revenue breakdown includes $30.5 million from ZORYVE cream 0.3%, $18.9 million from ZORYVE cream 0.15%, and $49.8 million from ZORYVE topical foam 0.3% [9] - The company anticipates full-year net product sales for 2026 to be between $455 million and $470 million [14] Product Development and Pipeline - ZORYVE is a potent PDE4 inhibitor approved for treating plaque psoriasis, atopic dermatitis, and seborrheic dermatitis, with ongoing Phase 2 studies for vitiligo and hidradenitis suppurativa [3][4][6] - The company is also advancing its clinical pipeline with ARQ-234, a potential biologic treatment for atopic dermatitis [8] Cost and Expenses - Cost of sales for Q3 2025 was $8.7 million, up from $5.5 million in Q3 2024, reflecting increased sales of ZORYVE [10] - Research and development expenses remained stable at $19.6 million, while selling, general, and administrative expenses rose to $62.4 million due to increased commercialization efforts [11][12] Profitability - Arcutis achieved a net income of $7.4 million, or $0.06 per share, compared to a net loss of $41.5 million in Q3 2024 [13][24]
Arcutis to Present New Quality of Life and Long-Term Data with ZORYVE® (roflumilast) Cream 0.15% and 0.05% for the Treatment of Atopic Dermatitis at the Fall Clinical Dermatology Conference
Globenewswire· 2025-10-24 12:00
Core Insights - Arcutis Biotherapeutics announced new data on ZORYVE® (roflumilast) cream, showing improvements in quality of life for atopic dermatitis patients, particularly in reducing sleep disruptions and providing long-term disease control for individuals aged 2 years and older [1][2][5] Clinical Data - ZORYVE cream demonstrated significant improvements in sleep and itch reduction in patients aged 2 to 5 years and 6 years and older, based on patient-reported outcomes from three Phase 3 trials [3][6] - The treatment was well-tolerated, with adverse events reported in ≤6% of patients, and serious adverse events in <1% [6][12] Long-term Efficacy - Long-term data from the INTEGUMENT-OLE trial indicated that ZORYVE cream maintained or improved disease control over 56 weeks, with a notable percentage of patients achieving 'Clear' or 'Almost Clear' status [8][12] - The median duration of disease control for patients switching to twice-weekly treatment was 238 days for children aged 2-5 and 281 days for older patients [12] Product Recognition - ZORYVE has received multiple awards, including the "2025 Best of Beauty Breakthrough Award" from Allure and the National Psoriasis Foundation's Seal of Recognition, highlighting its clinical impact and industry recognition [10] Indications and Usage - ZORYVE cream is indicated for the topical treatment of mild to moderate atopic dermatitis in pediatric patients aged 2 to 5 years and in patients aged 6 years and older [11][13]
FDA Approves Arcutis’ ZORYVE® (roflumilast) Cream 0.05% for the Treatment of Atopic Dermatitis in Children Ages 2 to 5
Globenewswire· 2025-10-06 12:00
Core Insights - The FDA has approved Arcutis Biotherapeutics' ZORYVE (roflumilast) cream 0.05% for treating mild to moderate atopic dermatitis in children aged 2 to 5 years, providing a steroid-free alternative for long-term use [1][6][23] - Approximately 1.8 million children in the U.S. aged 2 to 5 are treated for atopic dermatitis, highlighting a significant market need for effective treatments [2][6] - ZORYVE cream demonstrated rapid and significant improvements in clinical trials, with 40% of children achieving a 75% improvement in eczema symptoms within four weeks [2][12] Company Overview - Arcutis Biotherapeutics is focused on developing innovative treatments for immune-mediated dermatological diseases, with a growing portfolio of advanced topical therapies [30] - The approval of ZORYVE cream 0.05% marks the sixth FDA approval for the ZORYVE product line in just over three years, indicating strong regulatory momentum [1][6] - The company aims to ensure predictable access to ZORYVE through patient support programs, including the ZORYVE Direct Program and Arcutis Cares™ for financially eligible patients [4][30] Clinical Data - The FDA approval was based on results from the INTEGUMENT-PED Phase 3 trial, which involved 652 children and demonstrated rapid disease clearance and safety [10][11] - In the INTEGUMENT-PED trial, 25.4% of children treated with ZORYVE achieved a 'Clear' or 'Almost Clear' status by Week 4, compared to 10.7% in the vehicle group [12] - The long-term extension study (INTEGUMENT-OLE) showed that 71.9% of participants maintained a 75% improvement in eczema severity after 56 weeks of treatment [16] Market Context - Atopic dermatitis affects approximately 9.6 million children in the U.S., with a significant impact on family life due to sleep disruption and emotional distress [19][20] - ZORYVE is positioned as a leading topical therapy for atopic dermatitis, with recognition from industry awards, including Allure's "2025 Best of Beauty Breakthrough Award" [22][21] - The product's formulation targets underlying inflammation without compromising the skin barrier, making it particularly suitable for young children [3][21]
Arcutis Biotherapeutics, Inc. (ARQT) Hit a 52 Week High, Can the Run Continue?
ZACKS· 2025-10-01 14:16
Core Viewpoint - Arcutis Biotherapeutics, Inc. (ARQT) has experienced significant stock performance, with a 23% increase over the past month and a 35.3% gain since the beginning of the year, outperforming the Zacks Medical sector and the Zacks Medical - Biomedical and Genetics industry [1][3]. Financial Performance - The company has a strong record of positive earnings surprises, having beaten earnings consensus estimates in the last four quarters. In the latest earnings report on August 6, 2025, Arcutis reported an EPS of -$0.13, surpassing the consensus estimate of -$0.18, and beat the revenue estimate by 12.32% [2]. - For the current fiscal year, Arcutis is expected to post earnings of -$0.46 per share on revenues of $329.85 million, reflecting a 60.34% change in EPS and a 67.83% change in revenues. For the next fiscal year, the company is projected to earn $0.10 per share on revenues of $430.73 million, indicating a year-over-year change of 121.2% in EPS and 30.58% in revenues [3]. Valuation Metrics - Despite being at a 52-week high, the future valuation metrics are crucial for assessing potential stock performance. The Zacks Style Scores provide insights into various investment styles, with Arcutis having a Value Score of D, a Growth Score of A, and a Momentum Score of C, resulting in a VGM Score of B [4][6]. Zacks Rank - Arcutis Biotherapeutics holds a Zacks Rank of 2 (Buy), supported by a solid earnings estimate revision trend. This rank is considered more significant than the VGM Score, indicating a favorable outlook for the stock [7][8].
Arcutis Biotherapeutics to Host Virtual Investor Day and Report Third Quarter 2025 Financial Results on October 28, 2025
Globenewswire· 2025-09-29 20:00
Core Viewpoint - Arcutis Biotherapeutics, Inc. will report its third quarter 2025 financial results on October 28, 2025, and will host a virtual Investor Day to discuss these results and other strategic initiatives [1][2]. Company Overview - Arcutis Biotherapeutics is a commercial-stage medical dermatology company focused on innovative solutions for immune-mediated dermatological diseases, with a portfolio of advanced targeted topicals approved for three major inflammatory skin diseases [3]. - The company utilizes a unique dermatology development platform and expertise to create differentiated therapies targeting biologically validated conditions, resulting in a robust pipeline for various inflammatory dermatological issues [3]. Upcoming Events - The Investor Day will include presentations from the management team and a fireside chat with Douglas DiRuggiero, PA-C, DMSc, highlighting the company's strategy and clinical advancements [1][5]. - A Q&A session will follow the formal presentations, and a live webcast will be available on the company's website, with an archived replay posted afterward [2]. Strategic Focus - The event will provide an in-depth look into the company's long-term growth strategy for ZORYVE® (roflumilast), clinical development activities for new indications, and an overview of the capital allocation strategy and financial outlook [5].
Biotech Leader Arcutis Is Breaking Out, Up Nearly 36% In 2025
Investors· 2025-09-29 15:33
Group 1 - Arcutis Biotherapeutics (ARQT) is currently breaking out past two buy points, making it a top stock to watch in the S&P 500 for 2025 [1] - The company specializes in developing dermatology treatments for immune-related skin diseases and conditions, with its main product Zoryve foam approved by the U.S. FDA [1] - The Dow Jones index was flat as President Trump prepared for shutdown talks, while stocks like EA, Nvidia, and Tesla experienced rallies [2] Group 2 - Palantir is facing competition from Lockheed Martin as it aims for significant growth in the S&P 500, being noted as the index's biggest winner in 2025 [4] - The market is currently influenced by AI and gold, which are yielding substantial winners, with several stocks joining the IBD 50 list [4] - Despite a recent decline in indexes, stocks like Nvidia and Palantir are nearing buy points, with upcoming Fed inflation data expected to impact market movements [4]