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Arcutis Biotherapeutics, Inc. (ARQT)

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Previous Close25.51
Open24.55
Bid25.53 x 1400
Ask26.00 x 900
Day's Range25.17 - 26.20
52 Week Range17.10 - 40.88
Volume120,743
Avg. Volume229,096
Market Cap1.118B
Beta (5Y Monthly)N/A
PE Ratio (TTM)N/A
EPS (TTM)-10.27
Earnings DateNov 05, 2020
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est46.80
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    • Arcutis Announces Positive Topline Data from Phase 2b Study of ARQ-154 (Topical Roflumilast Foam) as a Potential Treatment for Scalp and Body Psoriasis
      GlobeNewswire

      Arcutis Announces Positive Topline Data from Phase 2b Study of ARQ-154 (Topical Roflumilast Foam) as a Potential Treatment for Scalp and Body Psoriasis

      * Roflumilast foam demonstrated statistically significant improvement on the trial’s primary and multiple secondary endpoints * Once-daily roflumilast foam demonstrated a favorable safety and tolerability profile * Roflumilast foam potential “Best in Class” topical scalp and body psoriasis treatment * Scalp psoriasis affects more than 2.5 million of the 6 million psoriasis patients in U.S with active disease * Company to host a conference call today at 8:30 a.m. ESTWESTLAKE VILLAGE, Calif., Nov. 23, 2020 (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 positive top line data from its Phase 2b clinical trial evaluating ARQ-154 (topical roflumilast foam) as a potential treatment for scalp psoriasis.Roflumilast foam 0.3% administered once daily for 8 weeks demonstrated statistically significant improvements compared to a matching vehicle foam on key efficacy endpoints in 304 adult and adolescent patients with plaque psoriasis that included plaques on the scalp. On the study’s primary endpoint of Scalp Investigator Global Assessment (S-IGA) success assessed at week 8, roflumilast foam 0.3% achieved a rate of 59.1% compared to a vehicle rate of 11.4% (p<0.0001). S-IGA success is defined as the achievement of an S-IGA score of 'clear' or 'almost clear' on a 5-grade scale plus at least a two-point change from baseline.   Onset was rapid, with significantly higher rates of S-IGA success noted as early as 2 weeks.Multiple secondary endpoints were also met. On the key secondary endpoint of Body Investigator Global Assessment (B-IGA) success assessed at week 8, roflumilast foam 0.3% achieved a rate of 40.3% compared to a vehicle rate of 6.8% (p<0.0001), with separation from vehicle on B-IGA success as early as 2 weeks. Symptomatic improvement was also demonstrated, with 71.0% of subjects treated with roflumilast foam 0.3% who had a baseline Scalp Itch Numeric Rating Scale (SI-NRS) score of 4 or greater achieving an itch reduction of at least 4 points at week 8 compared to 18.5% of vehicle treated subjects (p<0.0001). Consistent with other clinical trials of topical roflumilast, roflumilast foam was well-tolerated, as evidenced by subject-reported local tolerability and rates of application site adverse events, treatment-related adverse events, and discontinuations due to adverse events low and similar to vehicle. Only 5 out of 200 subjects (2.5%) in the roflumilast foam treated group discontinued the study due to an adverse event, compared to 2 out of 104 subjects (1.9%) treated with the vehicle.“Scalp psoriasis inflicts a high burden for patients, and current treatment options often carry significant treatment limitations that result in poor outcomes and can have a negative impact on patient quality of life,” said Leon Kircik, MD, Clinical Professor of Dermatology, Icahn School of Medicine at Mount Sinai, Indiana University Medical Center, and Medical Director, Physicians Skin Care, DermResearch, and Skin Sciences. “Roflumilast once-daily foam demonstrated rapid and significant improvements in psoriasis signs and symptoms, including reducing itch in a meaningful way. These positive results are encouraging for patients and clinicians who are desperate for new treatments that can simplify disease management, can be used in all areas of the body, and can ultimately improve the patient experience.”“Approximately 40 percent of the 6 million Americans afflicted with active, chronic psoriasis have scalp involvement, an area where treatment of scalp plaques is complicated by the difficulty of delivering topical drugs under the hair and to the surface of the skin,” said Linda F. Stein Gold, MD, Director of Dermatology Clinical Research at Henry Ford Health System in Detroit, Michigan, as well as Division Head of Dermatology at Henry Ford Health System in West Bloomfield, Michigan. “Novel treatments are needed, particularly ones like topical roflumilast foam that have the potential to be safe for chronic use; that are appropriate for application in hair-bearing areas where a cream, lotion, or ointment is not suitable; and that have demonstrated symptomatic improvement similar to high-potency steroids while also maintaining a favorable safety and tolerability profile. I believe these data demonstrate that once daily roflumilast foam could offer patients the efficacy and tolerability that they need. In my opinion, if approved, topical roflumilast foam has the potential to become an important treatment option for plaque psoriasis patients, particularly those with scalp involvement.”“We are delighted with these data, in which topical roflumilast foam demonstrated meaningful symptomatic improvement, alongside a favorable safety and tolerability profile that supports chronic use,” said Patrick Burnett, M.D., Ph.D., FAAD, and Chief Medical Officer of Arcutis. “With once-a-day dosing, roflumilast foam potentially offers the convenience of a simple, single, non-steroidal solution for both scalp and non-scalp plaques. If successful in Phase 3 clinical trials and approved for commercialization, roflumilast foam will be the first novel mechanism of action for the treatment of scalp and body psoriasis in decades. We believe it has the potential to positively affect the symptoms and quality of life of the millions of patients who suffer from this distressing chronic skin condition.”Management will host a conference call today at 8:30 a.m. EST to discuss these results. To access the call, please dial (833) 614-1393 (domestic) or (914) 987-7114 (international) prior to the scheduled conference call time and provide the conference ID 8960956. A live webcast of the call will be available on the "Investors" section of the company's website, www.arcutis.com. An archived version of the webcast will be available on the Arcutis website after the call.About Roflumilast Foam Roflumilast foam is a once-daily topical foam formulation of a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4 inhibitor) that Arcutis is developing particularly to treat inflammatory dermatoses in hair-bearing areas of the body such as the scalp.Roflumilast has been approved by the FDA for systemic 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.Arcutis believes roflumilast foam has significant potential as a treatment for scalp psoriasis and seborrheic dermatitis. Roflumilast foam is nearly identical to ARQ-151 (topical roflumilast cream), Arcutis’ investigational topical cream PDE4 inhibitor that has demonstrated symptomatic improvement and a favorable tolerability profile in Arcutis’ clinical trials in plaque psoriasis, as well as encouraging results in atopic dermatitis. Arcutis completed enrollment in DERMIS-1 and DERMIS-2, the Company’s pivotal Phase 3 clinical trials evaluating topical roflumilast cream as a potential topical treatment for plaque psoriasis, and the Company expects to announce topline data in the first quarter of 2021 and to submit a New Drug Application (NDA) submission by the end of 2021. In addition, following its End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), Arcutis plans to advance its program to develop topical roflumilast cream for the treatment of atopic dermatitis into Phase 3 clinical trials beginning in early 2021.About Scalp Psoriasis Scalp psoriasis is a manifestation of plaque psoriasis characterized by raised, red areas of skin (“plaques”) covered with a silver or white scale that occurs in the hair-bearing area of the scalp and sometimes extending to the forehead, back of the neck, or behind or inside the ears. Patients with scalp psoriasis commonly have plaques on other areas of the body as well. Approximately 40 percent of the estimated 8.6 million Americans with psoriasis have involvement of the scalp, and over a lifetime, up to 80 percent of psoriasis patients may experience scalp involvement. Scalp psoriasis plaques are identical to psoriatic plaques on other areas of the body; however, topical treatment of scalp plaques is complicated by the difficulty of delivering topical drugs under the hair and onto the skin. As with psoriatic plaques on other parts of the body, psoriasis on the scalp is often itchy and is sometimes painful. Scalp psoriasis can also be associated with hair loss, likely due to damage to the hair from excessive scratching, rubbing, or combing of the affected area. Often, patients require two or more medications to manage their disease when they have scalp involvement.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 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 roflumilast foam’s potential as a scalp and body psoriasis treatment and whether roflumilast cream’s Phase 2 results may be predictive of roflumilast foam’s potential clinical outcomes. 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-Q filed with U.S. Securities and Exchange Commission (SEC) on November 5, 2020, 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 Contact: Heather Rowe Armstrong Vice President, Investor Relations & Corporate Communications harmstrong@arcutis.com 805-418-5006, Ext. 740 A PDF accompanying this announcement is available at http://ml.globenewswire.com/Resource/Download/d3d13839-6109-4c6c-a20c-b9bb48d2c612

    • Arcutis Biotherapeutics to Present at the Stifel 2020 Virtual Healthcare Conference
      GlobeNewswire

      Arcutis Biotherapeutics to Present at the Stifel 2020 Virtual Healthcare Conference

      WESTLAKE VILLAGE, Calif., Nov. 11, 2020 (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 that Frank Watanabe, President and CEO, will present a corporate overview during the Stifel 2020 Virtual Healthcare Conference taking place November 16-18, 2020. Details for the presentation are as follows:         Stifel 2020 Virtual Healthcare Conference         Presentation Date: Wednesday, November 18, 2020         Presentation Time: 12:20 p.m. PST / 3:20 p.m. ESTThe presentation will be webcast and may be accessed at the “Events & Presentations” section of the Company’s website at https://investors.arcutis.com/events-and-presentations. Arcutis will maintain an archived replay of the webcast on its website for 30 days after the conference.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 www.arcutis.com or follow the company on LinkedIn and Twitter.Investor Contact: Heather Rowe Armstrong Vice President, Investor Relations & Corporate Communications harmstrong@arcutis.com 805-418-5006, Ext. 740

    • Arcutis Announces Third Quarter 2020 Financial Results and Provides Business Update
      GlobeNewswire

      Arcutis Announces Third Quarter 2020 Financial Results and Provides Business Update

      * Pivotal Phase 3 data in plaque psoriasis anticipated in first quarter of 2021 * Pivotal Phase 3 trials in atopic dermatitis anticipated to begin in late 2020 or early 2021 * Recent positive Phase 2 data in seborrheic dermatitis supports pipeline advancement in indication that impacts 10 million patients in the U.S. * Strong financial position with over $300 million in cash, cash equivalents and marketable securities including the proceeds from our recent equity offering, providing cash runway into 2022WESTLAKE VILLAGE, Calif., Nov. 05, 2020 (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 September 30, 2020, and provided a business update.“Arcutis is rapidly advancing an innovative and differentiated late-stage pipeline of potential best-in-class topical dermatology therapies, with five important clinical data readouts anticipated by mid-2021,” said Frank Watanabe, Arcutis’ President and Chief Executive Officer. “We expect to report topline data from our pivotal Phase 3 trials evaluating roflumilast cream as a potential once daily topical treatment for plaque psoriasis in the first quarter of next year and, if positive, anticipate submission of our New Drug Application to the U.S. Food and Drug Administration (FDA) by the end of 2021.  If approved, we believe roflumilast cream has the potential to eliminate the need for dermatologists and patients to compromise between efficacy and safety. Our focus on addressing the gap in dermatology drug development currently includes four product candidates in development for seven indications, with an addressable U.S. market of over 20 million patients.”Pipeline UpdateARQ-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. * Completed enrollment in the two on-going pivotal Phase 3 clinical trials (DERMIS-1 and-2) in patients with plaque psoriasis, with topline data anticipated in the first quarter of 2021. * On-going Phase 2 long-term safety study in plaque psoriasis has completed enrollment, with topline data anticipated in the first quarter of 2021.  In July, the Company announced positive preliminary efficacy and safety data for the first patient cohort from this study. * Results from the positive Phase 1/2a trial of ARQ-151 for the treatment of chronic plaque psoriasis were published in the Journal of Drugs in Dermatology. * Based on FDA feedback from an End-of-Phase 2 meeting, the Company expects to begin pivotal Phase 3 trials of ARQ-151 in patients with atopic dermatitis in late 2020 or early 2021.ARQ-154 (topical roflumilast foam) - a highly potent and selective phosphodiesterase type 4 (PDE4) inhibitor in a foam formulation, 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. * Reported positive topline data from Phase 2 clinical trial in seborrheic dermatitis, supporting pipeline advancement in an indication that impacts 10 million patients in the U.S. * Ongoing Phase 2b study in scalp psoriasis has completed enrollment, with topline data anticipated by the end of 2020.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. * Completed enrollment of the ongoing Phase 1/2b study in chronic hand eczema, with topline data anticipated by mid-2021. * The Company anticipates initiating a Phase 2a study in vitiligo in late 2020 or early 2021.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  * Bethany Dudek joined the Company as Vice President, Quality * Completed underwritten public offering and concurrent private placement of common stock with gross proceeds of $135 million.Third Quarter 2020 Summary Financial ResultsCash, cash equivalents and marketable securities were $189.7 million as of September 30, 2020, compared to $101.3 million as of December 31, 2019. Arcutis believes that its current cash, cash equivalents and marketable securities at over $300 million, including the $128.4 million net proceeds from our recent financing, will be sufficient to fund its operations into 2022.Research and development (R&D) expenses for the quarter ended September 30, 2020 were $32.7 million compared to $12.3 million for the corresponding period in 2019. R&D expenses for the nine months ended September 30, 2020 were $87.9 million compared to $25.8 million for the corresponding period in 2019. These year-over-year increases were primarily due to the initiation of multiple clinical trials during the last year.General and administrative (G&A) expenses for the quarter ended September 30, 2020 were $5.6 million compared to $2.3 million for the corresponding period in 2019. G&A expenses for the nine months ended September 30, 2020 were $14.6 million compared to $4.4 million for the corresponding period in 2019. These year-over-year increases were primarily due to higher headcount and professional services costs, including the costs associated with being a public company.Net loss was $38.2 million, or $1.01 per basic and diluted share, for the quarter ended September 30, 2020 compared to $14.5 million, or $7.56 per basic and diluted share, for the corresponding period in 2019.  Net loss was $101.6 million, or $3.06 per basic and diluted share, for the nine months ended September 30, 2020 compared to $29.4 million, or $16.60 per basic and diluted share, for the corresponding period in 2019.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 become the standard of care for plaque psoriasis, atopic dermatitis, scalp psoriasis, and seborrheic dermatitis. For more information, visit 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 its topical drugs in development to address large markets with significant unmet need; expectations with regard to the timing of data events and initiation of clinical trials anticipated during 2020/2021; and the Company’s belief that its current cash, cash equivalents and marketable securities will be sufficient to fund its operations into 2022. 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-Q filed with U.S. Securities and Exchange Commission (SEC) on November 5, 2020, 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 Communications harmstrong@arcutis.com  805-418-5006, Ext. 740 ARCUTIS BIOTHERAPEUTICS, INC. Condensed Balance Sheets (In thousands, except share and par value) September 30, December 31,  2020 2019  (Unaudited)   ASSETS    Current assets:    Cash and cash equivalents$45,707  $63,336  Marketable securities144,005  37,929  Prepaid expenses and other current assets4,409  5,209  Total current assets194,121  106,474  Property, plant, and equipment, net322  227  Operating lease right-of-use asset3,492  264  Other assets78  47  Total assets$198,013  $107,012  LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)    Current liabilities:    Accounts payable$5,039  $1,405  Accrued liabilities16,083  3,654  Operating lease liability32  178      Total current liabilities21,154  5,237  Operating lease liability, noncurrent3,675  129  Other long-term liabilities113  184  Total liabilities24,942  5,550    Convertible preferred stock—  166,491  Stockholders’ equity (deficit):      Preferred stock—  —    Common stock4  —  Additional paid-in capital340,964  1,244  Accumulated other comprehensive income (loss)4  (1) Accumulated deficit(167,901) (66,272)     Total stockholders’ equity (deficit)173,071  (65,029) Total liabilities, convertible preferred stock and stockholders’ equity (deficit)$198,013  $107,012  ARCUTIS BIOTHERAPEUTICS, INC.Condensed Statements of Operations and Comprehensive Loss (In thousands, except share and per share data) (unaudited) Three Months Ended September 30, Nine Months Ended September 30,  2020 2019 2020 2019 Operating expenses:        Research and development$32,743  $12,348  $87,934  $25,765  General and administrative5,560  2,300  14,647  4,373      Total operating expenses38,303  14,648  102,581  30,138  Loss from operations(38,303) (14,648) (102,581) (30,138) Other income, net99  168  952  710  Net loss$(38,204) $(14,480) $(101,629) $(29,428) Per share information:        Net loss per share, basic and diluted$(1.01) $(7.56) $(3.06) $(16.60) Weighted-average shares used in computing net loss per share, basic and diluted37,748,454  1,915,601  33,214,005  1,773,025