Findings show that seborrheic dermatitis is a unique inflammatory skin disease with its own molecular signatureSuggests skin barrier disruption in seborrheic dermatitis is distinct with its own disease-specific pattern SAN DIEGO, Calif., March 09, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, highlights new research that, for the first time, reveals the gene expression pro ...

Company Overview - Arcutis Biotherapeutics, Inc. is a commercial-stage biopharmaceutical company focused on immuno-dermatology, addressing the needs of individuals with immune-mediated dermatological diseases [5] - The company has a growing portfolio that includes two FDA-approved products and a robust pipeline targeting various inflammatory dermatological conditions such as scalp and body psoriasis, atopic dermatitis, and alopecia areata [5] Recent Offering - Arcutis announced the closing of its underwritten public offering of 18,157,895 shares of common stock at a price of $9.50 per share, resulting in total gross proceeds of approximately $172.5 million before deductions [1] - The offering included 2,368,421 shares issued upon the exercise of the underwriters' option to purchase additional shares [1] - Morgan Stanley, TD Cowen, and Guggenheim Securities acted as joint lead bookrunning managers for the offering, with Mizuho and Needham & Company serving as co-lead managers [2] Regulatory Compliance - The shares were offered pursuant to an effective shelf registration statement on Form S-3 filed with the SEC on January 31, 2024, with a final prospectus supplement available on the SEC's website [3]

Arcutis Biotherapeutics, Inc. (ARQT) closed the last trading session at $10.28, gaining 54.8% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $16.33 indicates a 58.9% upside potential.The average comprises six short-term price targets ranging from a low of $6 to a high of $38, with a standard deviation of $12.09. While the lowest estimate indicates a decline of 41.6% from the curre ...

For those looking to find strong Medical stocks, it is prudent to search for companies in the group that are outperforming their peers. Is Arcutis Biotherapeutics, Inc. (ARQT) one of those stocks right now? By taking a look at the stock's year-to-date performance in comparison to its Medical peers, we might be able to answer that question.Arcutis Biotherapeutics, Inc. is a member of our Medical group, which includes 1067 different companies and currently sits at #5 in the Zacks Sector Rank. The Zacks Sector ...

WESTLAKE VILLAGE, Calif., Feb. 29, 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 TD Cowen 44th Annual Health Care Conference. Details for the company's participation are as follows: Fireside Chat Date: Monday, March 4, 2024Fireside Chat Time: 2:10 pm ET The webcast for this conference may be accessed at the "E ...

WESTLAKE VILLAGE, Calif., Feb. 29, 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 TD Cowen 44th Annual Health Care Conference. Details for the company’s participation are as follows: Fireside Chat Date: Monday, March 4, 2024Fireside Chat Time: 2:10 pm ET The webcast for this conference may be accessed at the “ ...

WESTLAKE VILLAGE, Calif., Feb. 28, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT) a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the pricing of its underwritten public offering of common stock. Arcutis is selling 15,789,474 shares of common stock in the offering. The shares of common stock are being sold at a public offering price of $9.50 per share. All shares of common stock to be sold in the offering a ...

Company Overview - Arcutis Biotherapeutics, Inc. is a commercial-stage biopharmaceutical company focused on immuno-dermatology innovations [5] - The company has a growing portfolio that includes two FDA-approved products and a robust pipeline targeting inflammatory dermatological conditions such as scalp and body psoriasis, atopic dermatitis, and alopecia areata [5] Public Offering Announcement - Arcutis announced a public offering of $150 million in common stock and pre-funded warrants, with an additional 30-day option for underwriters to purchase up to $22.5 million more [1][2] - The offering is subject to market conditions and there is no assurance regarding its completion or terms [1] Underwriters and Registration - Morgan Stanley, TD Cowen, and Guggenheim Securities are the joint lead bookrunning managers for the offering, with Mizuho and Needham & Company as co-lead managers [2] - The securities are being offered under an effective shelf registration statement filed with the SEC on January 31, 2024 [2]

Core Insights - Arcutis Biotherapeutics has entered a strategic collaboration with Sato Pharmaceutical for the development and commercialization of topical roflumilast in Japan, which includes a $25 million upfront payment and potential milestone payments totaling $40 million [1][3] - The partnership aims to provide a novel non-steroidal treatment option for millions of Japanese patients suffering from inflammatory skin diseases [1][2] Financial Terms - Arcutis will receive an upfront payment of $25 million and may earn an additional $40 million based on achieving specific regulatory and sales milestones [3] - The company is also eligible for tiered, low double-digit percentage royalties from the sales of the product in Japan [3] Product Information - Topical roflumilast is a next-generation phosphodiesterase type 4 (PDE4) inhibitor, indicated for multiple dermatological conditions including plaque psoriasis, seborrheic dermatitis, and atopic dermatitis [1][4] - The product is being developed in cream and foam formulations, which are designed to be effective and well-tolerated for patients [2][4] Company Background - Arcutis Biotherapeutics focuses on innovations in immuno-dermatology and has a growing portfolio that includes FDA-approved products targeting immune-mediated dermatological diseases [8] - Sato Pharmaceutical is committed to healthcare innovation and provides high-quality products, particularly in dermatology [9]

Financial Data and Key Metrics Changes - The company achieved net product revenue of $29.2 million for ZORYVE in 2023, with $13.5 million in Q4, reflecting a 67% growth from Q3 to Q4 and approximately 70% sequential growth from Q2 to Q3 [25][26] - Full year total revenues reached $60 million, with $29.2 million in net product revenues and $30 million in other revenues related to a collaboration agreement [27] - R&D expenses for Q4 were $23.8 million, significantly down from Q4 2022 due to decreased development costs [27][28] - SG&A expenses for the year were $185 million, primarily due to higher commercialization expenses year-over-year [28] Business Line Data and Key Metrics Changes - ZORYVE cream prescriptions reached over 165,000, with TRx up 26% compared to Q3 2023 and over 290% compared to Q4 2022 [5][10] - The number of refills for ZORYVE cream increased by around 39% in Q4, now constituting more than one in three prescriptions [10] - ZORYVE foam launched successfully with a strong early response, achieving nearly 50% of total volume in covered prescriptions shortly after launch [17][18] Market Data and Key Metrics Changes - The total addressable market for ZORYVE is expected to grow around 10-fold to over 15 million patients in the U.S. in 2024 [8] - The company anticipates significant growth opportunities in Medicaid and Medicare, with plans to begin coverage negotiations in 2024 [14][60] Company Strategy and Development Direction - The company is focused on expanding the ZORYVE product line, with ongoing launches in plaque psoriasis and seborrheic dermatitis, and a potential launch for atopic dermatitis later in 2024 [7][19] - A secondary offering raised $102 million, strengthening the company's financial position to support ongoing product launches and pipeline development [7] - The company aims to improve gross-to-net metrics, targeting the mid-50s for psoriasis by the second half of 2024 [14][52] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory for ZORYVE products, citing strong prescription growth and positive feedback from healthcare providers [4][10] - The company anticipates a temporary erosion in psoriasis gross demand improvements in Q1 2024 due to typical deductible resets and patient coverage changes [26] - Management highlighted the importance of maintaining appropriate investments to support commercial activities and future launches [29][30] Other Important Information - The company received FDA approval for ZORYVE foam for seborrheic dermatitis in December 2023, with a launch in late January 2024 [6] - The FDA accepted a supplemental NDA for atopic dermatitis down to the age of six, with a target action date of July 7, 2024 [6][21] - The company has secured coverage for ZORYVE cream with all three large PBMs in the U.S. within 12 months of launch [13] Q&A Session Summary Question: What contributed to the early success of ZORYVE foam? - Management attributed the early success to a ready pool of patients who have been waiting for a more effective treatment, along with the absence of direct competitors [34][36] Question: What demographics are being observed for ZORYVE foam? - Management indicated it is too early to provide specific demographic data but noted a large pool of patients has been eagerly awaiting the product [41][42] Question: Are there any inventory or channel stocking effects expected in Q1? - Management does not anticipate any channel buildup for Q1 [46] Question: How many units of ZORYVE foam do patients expect to use annually? - Management anticipates that patients will use one to two units of ZORYVE foam per year [54][55] Question: What is the status of Medicaid and Medicare expansion opportunities? - Management is currently in negotiations with Part D Medicare plans and anticipates coverage to begin in the second half of 2024 [60][63]