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Arcutis Biotherapeutics, Inc. (ARQT)

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Previous Close25.55
Open25.40
Bid25.23 x 800
Ask35.49 x 900
Day's Range25.11 - 26.21
52 Week Range17.51 - 39.85
Volume305,674
Avg. Volume248,252
Market Cap1.293B
Beta (5Y Monthly)N/A
PE Ratio (TTM)N/A
EPS (TTM)-10.27
Earnings DateAug 09, 2021 - Aug 13, 2021
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est56.00
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    • Arcutis Biotherapeutics (NASDAQ:ARQT) Is In A Good Position To Deliver On Growth Plans
      Simply Wall St.

      Arcutis Biotherapeutics (NASDAQ:ARQT) Is In A Good Position To Deliver On Growth Plans

      There's no doubt that money can be made by owning shares of unprofitable businesses. For example, although...

    • Arcutis Biotherapeutics Showcases Pivotal DERMIS-1 and -2 Phase 3 Trial Data for Topical Roflumilast Cream (ARQ-151) in Plaque Psoriasis at EADV Spring Symposium 2021
      GlobeNewswire

      Arcutis Biotherapeutics Showcases Pivotal DERMIS-1 and -2 Phase 3 Trial Data for Topical Roflumilast Cream (ARQ-151) in Plaque Psoriasis at EADV Spring Symposium 2021

      Data show roflumilast produced robust efficacy compared to vehicle in both Phase 3 studies on the primary efficacy endpoint of IGA success at eight weeksRoflumilast also demonstrated statistically significant improvements over vehicle in the key secondary endpoints of I-IGA success, PASI-75, and reduction in itch as measured by WI-NRSImprovement in itch occurred as early as two weeks and improved consistently through week eightRoflumilast safety and tolerability were similar to vehicle WESTLAKE VILLAGE, Calif., May 06, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology, today announced the presentation of new data from the DERMIS-1 and DERMIS-2 pivotal Phase 3 studies evaluating roflumilast cream (ARQ-151) as a potential once daily, topical treatment for chronic plaque psoriasis at the European Association of Dermatology and Venereology (EADV) Spring Symposium. Roflumilast cream is a once daily topical formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4). Both Phase 3 trials achieved the primary efficacy endpoint of Investigator Global Assessment (IGA) Success at week eight, with significantly more patients treated with roflumilast cream 0.3% reaching IGA success compared to the control group of vehicle-treated patients (DERMIS-1: 42.4% vs. 6.1%; DERMIS-2: 37.5% vs. 6.9%, respectively, P<0.001 for both). IGA success is defined as clear or almost clear with at least a 2-grade improvement from baseline. “While nearly 90 percent of people with plaque psoriasis rely upon topical therapies, unfortunately, existing options often have significant shortcomings that force these patients and their dermatologists to make trade-offs between efficacy, safety, and tolerability,” said Patrick Burnett, M.D., Ph.D., FAAD, Arcutis’ Chief Medical Officer. “We are excited to share these Phase 3 trial findings, which we believe reinforce roflumilast cream as a potential topical treatment that is uniquely suited to address this unmet need and help those who have been struggling to treat their condition.” Roflumilast also demonstrated statistically significant improvements over vehicle in key secondary endpoints, including the treatment of psoriasis presenting in intertriginous areas (i.e., where two skin areas may touch or rub together), as measured by intertriginous-IGA (I-IGA) success (clear or almost clear with at least a 2-grade improvement from baseline). When plaque psoriasis presents in intertriginous areas, it can be particularly challenging to treat, with physicians often needing to prescribe a regimen of multiple medications for a single patient. In the Phase 3 trials, roflumilast was highly effective for intertriginous plaques, with significantly more roflumilast-treated patients reaching I-IGA success at week eight than vehicle-treated patients (DERMIS-1: 71.2% vs. 13.8%, P<0.0001; DERMIS-2: 68.1% vs 18.5%, P=0.0004), with the vast majority of these patients achieving I-IGA=0 (clear). “Historically, there has been a significant lack of innovation in the development of topical treatments for plaque psoriasis, with no novel nonsteroidal topical therapies approved in more than two decades,” said Mark Lebwohl, MD, Professor and Dean for Clinical Therapeutics, Icahn School of Medicine at Mount Sinai, and participant in the trial. “This needs to be remedied, as those who suffer from the burden of chronic plaque psoriasis and their doctors need and deserve better options. These data, which demonstrate a robust efficacy and safety profile for roflumilast cream, represent a hopeful sign for the possibility of advancing the care of this condition.” Other key Phase 3 findings include: Roflumilast was statistically superior to vehicle for improvement of psoriasis at all timepoints as measured by the Psoriasis Area Severity Index (PASI). Across both trials, approximately 40% of patients achieved a 75% reduction in PASI scores (PASI-75) by week eight (DERMIS-1: 41.6% vs 7.6%; DERMIS-2: 39.0% vs 5.3%, P<0.0001).Patients with clinically significant itch, as measured by a baseline Worst Itch-Numeric Rating Scale (WI-NRS) ≥4, achieved a 4-point reduction in WI-NRS at week eight (DERMIS-1: 67.5% vs 26.8%; DERMIS-2: 69.4% vs 35.6%, P<0.0001). Itch improvement was notable by two weeks, the earliest timepoint measured (DERMIS-2: P=0.0026), with consistent improvements achieved through week eight.Roflumilast safety and tolerability were similar to vehicle, including pooled rates of treatment-related treatment-emergent adverse events (AEs) (3.9% roflumilast vs. 3.6% vehicle), any AE leading to discontinuation (1.0% roflumilast vs 1.3% vehicle) and application site pain (1.0% roflumilast vs 0.3% vehicle). There were no treatment-related serious AEs, and local tolerability was highly favorable for roflumilast as reported by patient and investigator assessment of irritation, burning, and stinging. The “Trials of PDE4 inhibition with Roflumilast for the Management of plaque PsoriasIS” One and Two (or DERMIS-1 and DERMIS-2) were identical Phase 3 randomized, parallel, double-blind, vehicle-controlled, multi-national, multi-center studies in which roflumilast 0.3% cream or matching vehicle cream were applied once daily for 8 weeks to subjects age 2 years and above with mild, moderate, or severe chronic plaque psoriasis involving between 2% and 20% body surface area. DERMIS-1 enrolled 439 subjects, and DERMIS-2 enrolled 442 subjects. The primary endpoint of the studies was Investigator Global Assessment (IGA) Success at week 8. Multiple secondary endpoints were also evaluated, including intertriginous-IGA (I-IGA) Success, and improvements in Psoriasis Area Severity Index (PASI), itch as measured by the WI-NRS and patient perceptions of symptoms as measured by the Psoriasis Symptoms Diary (PSD). For more information, visit https://www.arcutis.com or follow the company on LinkedIn and Twitter. Join the conversation with the hashtag #EADVSymposium. Disclosure: Dr. Lebwohl has been a paid consultant and researcher for Arcutis. About Plaque PsoriasisPsoriasis is a common, non-contagious, immune-mediated skin disease that affects approximately 8.6 million patients in the United States. About 90% of patients develop plaque psoriasis, which is characterized by raised, red areas of skin covered with a silver or white layer of scale. Psoriatic plaques can appear on any area of the body, but most often appear on the scalp, knees, elbows, trunk, and limbs, and are often itchy and sometimes painful. Plaques in certain anatomical areas present particular treatment challenges, including the face, elbows and knees, scalp, and intertriginous regions such as the groin, axillae and inframammary areas. About Topical Roflumilast Cream Roflumilast Cream is a topical cream formulation of a highly potent and selective PDE4 inhibitor (roflumilast). Roflumilast has been approved by the U.S. Food and Drug Administration (FDA) for oral treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD) since 2011. Roflumilast has shown greater potency (25- to 300-fold) than the two other FDA-approved PDE4 inhibitors. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators and has been implicated in a wide range of inflammatory diseases including psoriasis, eczema, and COPD. PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the topical treatment of atopic dermatitis or the systemic treatment of plaque psoriasis. About ArcutisArcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology. The company is leveraging recent advances in immunology and inflammation to develop differentiated therapies against biologically validated targets to solve persistent treatment challenges in serious diseases of the skin. Arcutis’ robust pipeline includes four novel drug candidates currently in development for a range of inflammatory dermatological conditions. The company’s lead product candidate, topical roflumilast, has the potential to revitalize the standard of care for plaque psoriasis, atopic dermatitis, scalp psoriasis, and seborrheic dermatitis. For more information, visit https://www.arcutis.com or follow the company on LinkedIn and Twitter. Forward-Looking StatementsThis press release contains "forward-looking" statements, including, among others, statements regarding the potential for roflumilast to revolutionize the standard of care in plaque psoriasis and other inflammatory dermatological conditions. These statements involve substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements and you should not place undue reliance on our forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in the clinical development process and regulatory approval process, the timing of regulatory filings, and our ability to defend our intellectual property. For a further description of the risks and uncertainties applicable to our business, see the "Risk Factors" section of our Form 10-K filed with U.S. Securities and Exchange Commission (SEC) on February 16, 2021, as well as any subsequent filings with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Investor and Media Contact:Heather Rowe Armstrongharmstrong@arcutis.com805-418-5006 ext. 740 Media Contact:Erich Sandoval erich.sandoval@finnpartners.com917-497-2867

    • Arcutis Announces First Quarter 2021 Financial Results and Provides Business Update
      GlobeNewswire

      Arcutis Announces First Quarter 2021 Financial Results and Provides Business Update

      New Drug Application (NDA) submission for topical roflumilast cream as a potential treatment for plaque psoriasis anticipated in the second half of 2021Positive Phase 3 results for topical roflumilast cream in plaque psoriasis announced in FebruaryAdvancing topical roflumilast foam into Phase 3 development for the treatment of scalp psoriasis with a single pivotal trialProgressing topical roflumilast foam into Phase 3 development in seborrheic dermatitis with a single pivotal trialPivotal Phase 3 trials of topical roflumilast cream in atopic dermatitis initiated in JanuaryPhase 1/2b study of ARQ-252 in chronic hand eczema did not meet its primary endpointStrong financial position with over $440 million in cash, cash equivalents and marketable securities providing cash runway well into 2023 WESTLAKE VILLAGE, Calif., May 04, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology, today reported financial results for the quarter ended March 31, 2021, and provided a business update. “Building on the foundation of last year’s strong execution, the first quarter of 2021 was highly productive for Arcutis,” said Frank Watanabe, Arcutis’ President and Chief Executive Officer. “With the positive pivotal Phase 3 results in plaque psoriasis reported in February, we are on track to submit an NDA to the FDA in the second half of 2021 for topical roflumilast cream as a potential once daily topical treatment for plaque psoriasis. The robust Phase 3 data also reinforce our optimism for the multiple additional on-going development efforts with topical roflumilast cream and foam. We are also delighted that we were able to reach agreement with the FDA to advance roflumilast foam into Phase 3 development with a single pivotal study in scalp psoriasis.” Mr. Watanabe continued: “We are disappointed with the recent results of the ARQ-252 Phase 1/2b study in chronic hand eczema, a difficult disease to treat, and are undertaking further analyses to understand the data. Looking forward, we believe 2021 will be a transformational year for Arcutis as we have begun our plaque psoriasis commercialization efforts in earnest, and continue to rapidly advance an innovative and differentiated late-stage pipeline of potential best-in-class topical dermatology therapies.” Pipeline Updates ARQ-151 (topical roflumilast cream) - a highly potent and selective phosphodiesterase type 4 (PDE4) inhibitor in a cream formulation, being developed as a potential treatment for plaque psoriasis, including intertriginous psoriasis, and atopic dermatitis. Reported positive results from the two pivotal Phase 3 clinical trials (DERMIS-1 and DERMIS-2) in patients with plaque psoriasis; NDA submission to U.S. Food and Drug Administration (FDA) anticipated in the second half of 2021.Pivotal Phase 3 trials in patients with atopic dermatitis (INTEGUMENT-1, INTEGUMENT-2, and INTEGUMENT-PED) have been initiated, with topline data anticipated in the second half of 2022. ARQ-154 (topical roflumilast foam) - an alternative topical foam formulation of roflumilast designed to overcome the challenges of delivering topical drugs in hair-bearing areas of the body, being developed as a potential treatment for seborrheic dermatitis and scalp psoriasis. Following a recent End-of-Phase 2 meeting with the FDA, the Company is advancing roflumilast foam into Phase 3 development for the treatment of scalp psoriasis in a single pivotal trial, with topline data anticipated in the second half of 2022.After a previous FDA End-of-Phase 2 meeting early in Q1, announced advancement of roflumilast foam into Phase 3 development for the treatment of seborrheic dermatitis in a single pivotal trial, with topline data anticipated in the second or third quarter of 2022. ARQ-252 - a potent and highly selective topical small molecule inhibitor of Janus kinase type 1 (JAK1), being developed as a potential treatment for chronic hand eczema and other inflammatory dermatoses. The Phase 2 study of ARQ-252 in chronic hand eczema did not meet its primary endpoint of Investigator Global Assessment (IGA) of clear or almost clear at week 12. In the study, none of the ARQ-252 arms achieved statistical significance versus vehicle. Further analyses of the data are underway. ARQ-252 was generally safe and well-tolerated.Initiated a Phase 2a clinical trial evaluating ARQ-252 as a potential treatment for vitiligo with topline data anticipated in the second half of 2023. ARQ-255 - an alternative topical formulation of ARQ-252 designed to reach deeper into the skin in order to potentially treat alopecia areata. Formulation and preclinical efforts are underway. Recent Corporate Highlights Scott Burrows, previously Vice President of Finance, was appointed Senior Vice President and Chief Financial Officer, following the retirement of John SmitherCourtney Barton joined the Company as Vice President, Chief Compliance Officer, and Chief of StaffCorey Padovano joined the Company as Vice President of SalesSean Brugger joined the Company as Executive Director of Field Medical AffairsCompleted underwritten public offering of common stock in February 2021 with gross proceeds of $221.4 million and net proceeds of $207.5 million First Quarter 2021 Summary Financial Results Cash, cash equivalents, restricted cash and marketable securities were $446.5 million as of March 31, 2021, compared to $286.0 million as of December 31, 2020. Arcutis believes that its current cash, cash equivalents and marketable securities will be sufficient to fund its operations well into 2023. Research and development (R&D) expenses for the quarter ended March 31, 2021 were $21.6 million compared to $25.2 million for the corresponding period in 2020. The year-over-year decrease was primarily due to the completion of our Phase 3 studies of roflumilast cream in plaque psoriasis and Phase 2 studies of roflumilast foam in seborrheic dermatitis and scalp psoriasis, offset partially by increased clinical costs for our Phase 3 studies of roflumilast cream in atopic dermatitis and Phase 2 studies of ARQ-252 in hand eczema and vitiligo, as well as increased product development expenses. General and administrative (G&A) expenses for the quarter ended March 31, 2021 were $14.5 million compared to $3.5 million for the corresponding period in 2020. The year-over-year increase was primarily due to higher headcount and professional services costs, as well as a one-time $5.3 million non-cash charge for modifications to previously granted stock awards in connection with an officer's retirement. Net loss was $36.0 million, or $0.76 per basic and diluted share, for the quarter ended March 31, 2021 compared to $28.0 million, or $1.15 per basic and diluted share, for the corresponding period in 2020. About Arcutis - Bioscience, applied to the skin. Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology. The company is leveraging recent advances in immunology and inflammation to develop differentiated therapies against biologically validated targets to solve persistent treatment challenges in serious diseases of the skin. Arcutis’ robust pipeline includes four novel drug candidates currently in development for a range of inflammatory dermatological conditions. The company’s lead product candidate, topical roflumilast, has the potential to revitalize the standard of care for plaque psoriasis, atopic dermatitis, scalp psoriasis, and seborrheic dermatitis. For more information, visit https://www.arcutis.com or follow the company on LinkedIn and Twitter. Forward Looking Statements This press release contains "forward-looking" statements, including, among others, statements regarding the potential for its topical drugs in development to address large markets with significant unmet need; expectations with regard to the timing of data events anticipated during 2021/2022; and the Company’s belief that its current cash, cash equivalents and marketable securities, including the net proceeds from its recent financing, will be sufficient to fund its operations into 2023. These statements involve substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements and you should not place undue reliance on our forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in the clinical development process and regulatory approval process, the timing of regulatory filings, and our ability to defend our intellectual property. For a further description of the risks and uncertainties applicable to our business, see the “Risk Factors” section of our Form 10-K filed with U.S. Securities and Exchange Commission (SEC) on February 16, 2021, as well as any subsequent filings with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Contact:Heather Rowe Armstrong Vice President, Investor Relations & Corporate Communicationsharmstrong@arcutis.com805-418-5006, Ext. 740 ARCUTIS BIOTHERAPEUTICS, INC.Condensed Balance Sheets(In thousands) March 31, December 31, 2021 2020 (Unaudited) ASSETS Current assets: Cash and cash equivalents$288,690 $65,082 Restricted cash1,542 1,542 Marketable securities156,237 219,359 Prepaid expenses and other current assets19,506 6,843 Total current assets465,975 292,826 Property and equipment, net2,094 2,016 Operating lease right-of-use asset3,269 3,349 Other assets78 78 Total assets$471,416 $298,269 LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable$3,146 $7,140 Accrued liabilities12,168 15,462 Total current liabilities15,314 22,602 Operating lease liability, noncurrent5,050 4,964 Other long-term liabilities58 82 Total liabilities20,422 27,648 Stockholders’ equity: Common stock5 4 Additional paid-in capital688,939 472,569 Accumulated other comprehensive income (loss)42 (2)Accumulated deficit(237,992) (201,950)Total stockholders’ equity450,994 270,621 Total liabilities, convertible preferred stock and stockholders’ equity$471,416 $298,269 ARCUTIS BIOTHERAPEUTICS, INC.Condensed Statements of Operations and Comprehensive Loss(In thousands, except share and per share data) Three Months Ended March 31, 2021 2020 (unaudited)Operating expenses: Research and development$21,631 $25,182 General and administrative14,454 3,469 Total operating expenses36,085 28,651 Loss from operations(36,085) (28,651)Other income, net43 638 Net loss$(36,042) $(28,013)Per share information: Net loss per share, basic and diluted$(0.76) $(1.15)Weighted-average shares used in computing net loss per share, basic and diluted47,280,769 24,256,402