Arcutis Biotherapeutics

Arcutis Biotherapeutics, Inc. engages in the development and commercialization of treatments for dermatological diseases. Its pipeline consists of topical treatments for plaque psoriasis, atopic dermatitis, hand eczema, vitiligo, scalp psoriasis, alopecia areata, and seborrheic dermatitis. The company was founded by Bhaskar Chaudhuri and David W. Osborne in June 2016 and is headquartered in Westlake Village, CA.

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Arcutis Biotherapeutics reports successful 2022 performance and growth strategies

Arcutis Biotherapeutics showcased strong performance in 2022, with ZORYVE's success and pipeline progress driving revenue growth. The company's strategic focus on non-steroidal treatments aligns with changing standards of care and patient preferences. Challenges in maintaining gross-to-net and competition comparisons are areas of focus for sustainable growth.

Arcutis Biotherapeutics reports strong Q1 performance and growth opportunities

Arcutis Biotherapeutics showcased strong performance in Q1 2023, driven by ZORYVE's growth and expanding commercial coverage.
Despite challenges with gross-to-net dynamics and operational issues, the company remains confident in demand growth and product feedback.
Strategic initiatives focusing on market penetration, education, and partnerships position Arcutis well for future growth and product success.
Expansion into Canada, pricing strategy alignment, and disease awareness efforts offer promising opportunities for market expansion and acceptance.

Arcutis Biotherapeutics excels in Q2 with ZORYVE's growth and market expansion

Arcutis Biotherapeutics delivered a strong Q2 performance driven by ZORYVE's successful launch and coverage expansion, positioning the company for continued growth in Q3 and Q4.
Despite facing challenges in physician adoption and managing expenses, Arcutis benefits from key strengths like broad market access, positive physician feedback, and a robust patent estate.
With opportunities to capitalize on key payer agreements, expand into new indications, and drive market differentiation, Arcutis is poised for strategic growth and market expansion in the dermatology sector.

Arcutis Biotherapeutics excels in Q3, eyes market expansion opportunities

Arcutis Biotherapeutics showcased strong financial performance and key achievements in Q3 2023.
The successful ZORYVE launch and positive Phase III data highlight growth potential.
Strategic partnerships and market expansion plans position the company for future success.
Efforts to drive ZORYVE utilization and navigate market challenges are key focus areas.

Arcutis Biotherapeutics excels in Q4, poised for market expansion

Arcutis Biotherapeutics delivered strong financial performance and market acceptance in Q4 2023.
The company's focus on expanding its product portfolio and market reach bodes well for future growth.
Challenges in coverage negotiations and patient engagement require strategic solutions for sustained success.
Overall, Arcutis is well-positioned to capitalize on market opportunities and drive continued growth.

Arcutis Biotherapeutics reports strong Q1 performance and eyes market expansion

Arcutis Biotherapeutics anticipates sustained growth in 2024 and beyond, aiming to positively impact patients with chronic dermatologic diseases.
The company's focus on partnerships, market access optimization, and product expansion positions them well for future success in the dermatology market.
Despite challenges such as regulatory milestones and partnership negotiations, Arcutis remains confident in their ability to navigate these hurdles and drive continued growth.

Arcutis Biotherapeutics excels in Q2 2024, poised for growth

Arcutis Biotherapeutics delivered a strong performance in Q2 2024, driven by the success of ZORYVE products and strategic financial management.
While facing challenges in market expansion and operational efficiency, the company's focus on growth opportunities and profitability strategies bode well for future success.
Overall, Arcutis Biotherapeutics remains well-positioned to capitalize on market opportunities, expand product reach, and drive sustained revenue growth.

Arcutis Biotherapeutics excels in Q3, eyes growth through partnerships

Arcutis Biotherapeutics demonstrated strong sales growth, improved market access, and product label expansions in Q3 2024, positioning the company for future success.
While challenges like achieving breakeven and optimizing partnerships exist, opportunities from upcoming approvals and market trends present avenues for sustained growth.
Overall, Arcutis Biotherapeutics' strategic initiatives and performance in Q3 underscore its potential for long-term success and market leadership in dermatology.

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Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT ) Q3 2024 Earnings Conference Call November 6, 2024 4:30 PM ET Company Participants Latha Vairavan - Vice President, Finance and Investor Relations Frank Watanabe - President and CEO Todd Edwards - Chief Commercial Officer Patrick Burnett - Chief Medical Officer David Topper - Chief Financial Officer Conference Call Participants Vikram Purohit - Morgan Stanley Seamus Fernandez - Guggenheim Securities Uy Ear - Mizuho Serge Belanger - Needham & Co. Kambiz Yazdi - Jefferies Operator Good day, and welcome to the Arcutis Biotherapeutics 2024 Third Quarter Financial Results Conference Call. At this time, all participants are in a listen-only mode.

Arcutis Biotherapeutics, Inc. (ARQT) Q3 2024 Earnings Call Transcript

Arcutis Biotherapeutics, Inc. (ARQT) came out with a quarterly loss of $0.33 per share versus the Zacks Consensus Estimate of a loss of $0.42. This compares to loss of $0.73 per share a year ago.

Arcutis Biotherapeutics, Inc. (ARQT) Reports Q3 Loss, Tops Revenue Estimates

Third quarter net product revenues for ZORYVE® (roflumilast) franchise of $44.8M, with $22.0M for ZORYVE cream 0.3%, $20.3M for ZORYVE topical foam 0.3%, and $2.5M for ZORYVE cream 0.15%; sales growth of 452% vs. Q3 '23 and 45% vs.

Arcutis Announces Third Quarter 2024 Financial Results and Provides Business Update

WESTLAKE VILLAGE, Calif., Nov. 04, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported the grant of an aggregate of 50,000 restricted stock units of Arcutis' common stock as well as options to purchase an aggregate of 50,000 shares of Arcutis' common stock to five newly hired employees. These awards were approved by the Compensation Committee of Arcutis' Board of Directors and granted under the Arcutis Biotherapeutics, Inc. 2022 Inducement Plan, with a grant date of November 1, 2024, as an inducement material to the new employees entering into employment with Arcutis, in accordance with Nasdaq Listing Rule 5635(c)(4).

Arcutis Biotherapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Arcutis Biotherapeutics (ARQT) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Arcutis Biotherapeutics, Inc. (ARQT) May Report Negative Earnings: Know the Trend Ahead of Q3 Release

WESTLAKE VILLAGE, Calif., Oct. 23, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that it will report third quarter 2024 financial results and provide a business update on Wednesday, November 6, 2024 after the U.S. financial markets close. The Company will also host a conference call and webcast the same day at 4:30 p.m. ET.

Arcutis to Report Third Quarter 2024 Financial Results and Participate in an Upcoming Investor Conference

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ZORYVE foam represents the first topical treatment for seborrheic dermatitis with a new mechanism of action approved in Canada in over two decades1 Second approval of ZORYVE outside of the United States, expanding ZORYVE portfolio availability to over 2 million Canadians living with seborrheic dermatitis WESTLAKE VILLAGE, Calif., Oct. 18, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that its wholly-owned subsidiary Arcutis Canada, Inc. has received regulatory approval from Health Canada for ZORYVE (roflumilast) topical foam 0.3% for the treatment of seborrheic dermatitis in patients 9 years of age and older.

Arcutis Announces Health Canada Approval of ZORYVE® (Roflumilast) Foam 0.3% to Treat Seborrheic Dermatitis in Individuals 9 Years of Age and Older

ZORYVE demonstrated consistent efficacy in disease clearance and reduction in itch for individuals with atopic dermatitis (AD) regardless of race, ethnicity, and Fitzpatrick skin type ZORYVE was safe and well tolerated across all subgroups Data presented at the 2024 European Academy of Dermatology & Venereology Congress WESTLAKE VILLAGE, Calif., Sept. 24, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology and immunology, today announced new pooled subgroup analysis results from the Phase 3 INTEGUMENT-1 and -2 trials showing that ZORYVE cream 0.15% provided consistent and meaningful improvements in signs and symptoms of AD in individuals regardless of race, ethnicity, and Fitzpatrick skin types.

New Data Shows ZORYVE® (Roflumilast) Cream 0.15% Provided Consistent Improvement of Atopic Dermatitis in Individuals With Diverse Skin Types

U.S. Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) target action date of May 22, 2025 Almost half of the 9 million individuals in the United States with plaque psoriasis experience involvement of the scalp Supplemental New Drug Application (sNDA) supported by positive efficacy and safety data from Phase 2b and pivotal Phase 3 trials, and long-term ZORYVE cream plaque psoriasis program WESTLAKE VILLAGE, Calif., Sept. 24, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the FDA has accepted its sNDA for ZORYVE (roflumilast) foam 0.3%, a once-daily, next generation phosphodiesterase-4 (PDE4) inhibitor, for the treatment of adults and adolescents ages 12 and over with scalp and body psoriasis.

FDA Accepts Arcutis' Supplemental New Drug Application for ZORYVE® (roflumilast) Foam for the Treatment of Scalp and Body Psoriasis in Adults and Adolescents Ages 12 and Over

Arcutis Biotherapeutics, Inc. is a biotech company based in California that markets two dermatological products, ZORYVE cream and foam, containing roflumilast, a PDE4 inhibitor. Despite initial struggles post-IPO, Arcutis has seen a significant increase in revenues and a narrowing of losses in Q2 2024, with new product approvals and collaborations. Analysts predict strong growth potential for ZORYVE, but competition in the dermatological market poses a challenge for Arcutis to maintain and grow market share.

Arcutis: Shares Plateau After Early 2024 Gains, But Further Upside Looks Likely

WESTLAKE VILLAGE, Calif., Aug. 22, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that Arcutis management will participate in the Morgan Stanley 22nd Annual Global Healthcare Conference.

Arcutis to Present at the Morgan Stanley 22nd Annual Global Healthcare Conference

Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT ) Q2 2024 Earnings Conference Call August 14, 2024 4:30 PM ET Company Participants Latha Vairavan - VP, Finance and Head of IR Frank Watanabe - President & CEO Todd Edwards - Chief Commercial Officer Patrick Burnett - Chief Medical Officer David Topper - CFO Conference Call Participants Vikram Purohit - Morgan Stanley Tyler Van Buren - TD Cowen Seamus Fernandez - Guggenheim Securities Uy Ear - Mizuho Securities Serge Belanger - Needham Chris Shibutani - Goldman Sachs Operator Hello, and thank you for standing by. Welcome to Arcutis Biotherapeutics Q2 2024 Earnings Call.

Arcutis Biotherapeutics, Inc. (ARQT) Q2 2024 Earnings Call Transcript

WESTLAKE VILLAGE, Calif., Aug. 14, 2024 (GLOBE NEWSWIRE) -- In a release issued under the same headline earlier today by Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), please note that in the section of Recent Corporate Highlights, in the third bullet point, the date for the extended maturity should be August 2029, not June 2029.

CORRECTION – Arcutis Announces Second Quarter 2024 Financial Results and Provides Business Update

Arcutis Biotherapeutics, Inc. (ARQT) came out with a quarterly loss of $0.42 per share versus the Zacks Consensus Estimate of a loss of $0.48. This compares to loss of $1.16 per share a year ago.

Arcutis Biotherapeutics, Inc. (ARQT) Reports Q2 Loss, Misses Revenue Estimates

Second quarter net product revenues for ZORYVE® franchise of $30.9M, with $17.3M for ZORYVE (roflumilast) cream 0.3%, and $13.6M for ZORYVE (roflumilast) topical foam, 0.3%; sales growth of 547% vs. Q2 '23 and 43% vs.

Arcutis Announces Second Quarter 2024 Financial Results and Provides Business Update

Will Arcutis Biotherapeutics, Inc. (ARQT) Report Negative Earnings Next Week? What You Should Know

Over 200-person sales force to promote ZORYVE (roflumilast) in primary care and pediatric practices Provides access to a large portion of the 7.4 million individuals treated for plaque psoriasis, seborrheic dermatitis, and atopic dermatitis outside of dermatology offices ZORYVE will be promoted in the primary position to maximize prescriber education WESTLAKE VILLAGE, Calif. and MONTGOMERY, Ala.

Arcutis Announces ZORYVE® U.S. Co-promote Agreement with Kowa Pharmaceuticals America, Inc.

Once-daily, effective, safe, and well-tolerated ZORYVE cream now commercially available Provides rapid clearance of atopic dermatitis signs and symptoms and significant reduction in itch, and can be used anywhere on the body for any duration to maintain clear skin Atopic dermatitis is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United States Management will host an investor event with a key opinion leader on Monday, July 29 at 8:30 am EDT/5:30 am PDT WESTLAKE VILLAGE, Calif., July 29, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the commercial launch of ZORYVE® (roflumilast) cream 0.15% for the treatment of mild to moderate atopic dermatitis in adults and children down to age 6 in the United States.

Arcutis Launches ZORYVE® (roflumilast) Cream 0.15% for the Treatment of Atopic Dermatitis

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WESTLAKE VILLAGE, Calif., July 22, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that it will host a virtual Key Opinion Leader (KOL) event featuring a leading dermatology and immune-mediated skin disease expert to discuss the unmet need and current treatment landscape for individuals with mild to moderate atopic dermatitis (AD).

Arcutis to Host ZORYVE® (Roflumilast) Cream 0.15% FDA Approval Call With KOL

Here is how Arcutis Biotherapeutics, Inc. (ARQT) and Sensus Healthcare, Inc. (SRTS) have performed compared to their sector so far this year.

Is Arcutis Biotherapeutics (ARQT) Stock Outpacing Its Medical Peers This Year?

Arcutis (ARQT) rises 30.9% in a month after the label expansion of its marketed product, Zoryve cream 0.15%, for the AD indication in adult and pediatric patients aged six years and older.

Arcutis (ARQT) Stock Rises 31% in the Past Month: Here's Why

ZORYVE cream provides rapid relief, with efficacy, safety, and tolerability demonstrated up to 56 weeks of treatment ZORYVE cream rapidly and significantly reduces itch, the most bothersome symptom of atopic dermatitis (AD) Once-daily cream is for use anywhere on the body for any duration AD is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United States Third FDA approval for Company in two years Commercial product expected to be available by the end of July WESTLAKE VILLAGE, Calif., July 09, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for ZORYVE (roflumilast) cream, 0.15%, for the treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older.

FDA Approves Arcutis' ZORYVE® (roflumilast) Cream 0.15% for the Treatment of Atopic Dermatitis in Adults and Children Down to 6 Years of Age

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