Core Insights - Arcutis Biotherapeutics, Inc. will participate in the TD Cowen 45th Annual Health Care Conference from March 3-5, 2025, with a fireside chat scheduled for March 4, 2025, at 9:50 am EST [1] - The company focuses on developing innovations in immuno-dermatology, addressing the needs of patients with immune-mediated dermatological diseases [2] Company Overview - Arcutis Biotherapeutics is a commercial-stage medical dermatology company with a commitment to addressing urgent patient needs in dermatology [2] - The company has a growing portfolio that includes three FDA-approved products and a robust pipeline targeting various inflammatory dermatological conditions such as scalp and body psoriasis, atopic dermatitis, and alopecia areata [2]

Core Viewpoint - Arcutis Biotherapeutics, Inc. (ARQT) has shown a 0.8% increase in share price over the past four weeks, closing at $12.78, with a potential upside of 51.6% based on Wall Street analysts' mean price target of $19.38 [1] Price Targets - The average price target consists of eight estimates ranging from a low of $12 to a high of $29, with a standard deviation of $4.78, indicating variability among analysts [2] - The lowest estimate suggests a decline of 6.1%, while the highest indicates a potential upside of 126.9% [2] - A low standard deviation signifies greater agreement among analysts regarding price movement [7] Analyst Sentiment - Analysts are increasingly optimistic about ARQT's earnings prospects, as evidenced by a trend of higher EPS estimates, which correlates with potential stock price increases [9] - Over the last 30 days, the Zacks Consensus Estimate for the current year has risen by 7.7%, with no negative revisions [10] Zacks Rank - ARQT holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, indicating strong potential for upside [11] Caution on Price Targets - Solely relying on consensus price targets for investment decisions may not be prudent, as analysts' ability to set accurate targets has been questioned [3][5] - Analysts often set optimistic price targets due to business incentives, which can lead to inflated estimates [6] - While price targets should not be ignored, they should be approached with skepticism, as they may not reliably indicate actual stock price movements [8]

Odell Beckham Jr. first noticed flakes throughout his iconic beard and hairline in his 20s; today, for the first time he is sharing his experience with ZORYVE® (roflumilast) topical foam, 0.3%, to help others learn more about this chronic inflammatory skin condition ZORYVE foam is a once-daily, steroid-free, topical for seborrheic dermatitis uniquely formulated for use anywhere on the body, including hair-bearing areas Seborrheic dermatitis impacts more than 10 million Americans and is the third most commo ...

Company Overview - Arcutis Biotherapeutics, Inc. is a commercial-stage biopharmaceutical company focused on immuno-dermatology, addressing urgent needs in immune-mediated dermatological diseases [2] - The company has a growing portfolio that includes three FDA-approved products and a robust pipeline targeting various inflammatory dermatological conditions such as scalp and body psoriasis, atopic dermatitis, and alopecia areata [2] Upcoming Events - Arcutis management will participate in the Guggenheim SMID Cap Biotech Conference on February 5-6, 2025, with a fireside chat scheduled for February 6, 2025, at 1:00 pm ET [1] - The conference webcast will be accessible on the company's website, with a replay available for 180 days post-conference [1]

Core Viewpoint - Arcutis Biotherapeutics, Inc. (ARQT) shows potential for significant upside, with a mean price target of $19.13 indicating a 37.4% increase from the current price of $13.92 [1] Price Targets and Estimates - The mean estimate consists of eight short-term price targets with a standard deviation of $4.79, indicating variability among analysts; the lowest estimate is $12 (13.8% decline), while the highest is $29 (108.3% increase) [2] - A low standard deviation suggests a high degree of agreement among analysts regarding the stock's price movement direction, which can serve as a starting point for further research [7] Earnings Estimates - Analysts are optimistic about ARQT's earnings prospects, as indicated by a positive trend in earnings estimate revisions; the Zacks Consensus Estimate for the current year has increased by 8.9% over the last 30 days, with no negative revisions [10][9] - ARQT holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates, which supports the stock's potential upside [11] Analyst Behavior - Analysts often set overly optimistic price targets due to business incentives, which can lead to inflated estimates; thus, investors should approach price targets with skepticism [6][8]

Financial Results and Business Update - The company will report complete fourth quarter and full-year 2024 financial results and provide a business update on February 25, 2025, after the US financial markets close [1] - A conference call and webcast will be hosted on the same day at 4:30 pm EST, with live webcast and presentation materials available on the company's website [1] - An archived replay of the webcast will be available on the Arcutis investor website following the conference call [1] Company Overview and Product Portfolio - Arcutis is a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology [3] - The company has a growing portfolio including three FDA-approved products that leverage its unique dermatology development platform and expertise [2] - The dermatology development platform includes a robust pipeline with multiple clinical programs for a range of inflammatory dermatological conditions [2] Preliminary Financial Information - Preliminary unaudited product revenue for the fourth quarter of 2024 is expected to be approximately $63 million, up 366% vs Q4 2023 and 41% vs Q3 2024 [6][9] - Preliminary unaudited product revenue for the full-year 2024 is expected to be approximately $160 million, up 449% vs 2023 [6][9] - Revenue growth in the fourth quarter was driven by strong demand for all ZORYVE indications, while GTN was similar to the prior quarter [9] - Preliminary unaudited cash, cash equivalents, restricted cash, and marketable securities as of December 31, 2024 are expected to be approximately $229 million [6][9] - The company repaid $100 million of its long-term debt held by SLR Investment Corp and has the option to re-draw approximately $100 million by the first half of 2026, making total liquidity as of December 31, 2024 approximately $329 million [9] Business Outlook and Strategy - The company anticipates sustained ZORYVE sales growth throughout 2025 as multiple product launches gain further traction and new approvals are secured [5] - Expansion of insurance coverage and broader access to primary care and pediatric practices through the commercial partnership with Kowa are expected to drive growth [5] - Management will host in-person investor meetings in San Francisco, CA, around the 43rd Annual J P Morgan Healthcare Conference, being held January 13-16, 2025 [5]

ARQT Stock Performance - Arcutis' stock has surged over 272% in the past year, significantly outperforming the industry's 14 1% decline [1] - The stock's rise is primarily driven by positive regulatory updates regarding the expansion of Zoryve's label [6] ARQT's Zoryve Product - Zoryve is currently approved in different formulations (foam and cream) for various indications [6] - A 0 3% formulation of Zoryve cream is approved for plaque psoriasis in patients six years and older and for seborrheic dermatitis in patients nine years and above [9] - A 0 15% formulation of Zoryve cream was approved in July for mild to moderate atopic dermatitis (AD) in patients six years and older [9] - A 0 15% formulation of Zoryve foam is approved for seborrheic dermatitis in individuals aged nine years and older [9] ARQT's Regulatory Updates - Arcutis submitted an sNDA to the FDA for Zoryve cream 0 05% to treat mild to moderate AD in children two to five years old [7] - An sNDA for Zoryve foam 0 3% to treat scalp and body psoriasis is under FDA review, with a final decision expected in May 2025 [7] - Potential approvals for these indications are expected to boost revenues in 2025 [7] ARQT's Financial Performance - Zoryve has driven strong revenue growth, with product revenues reaching $97 million in the first nine months of 2024, up more than 500% year-over-year [11] Other Biotech Stocks - Castle Biosciences (CSTL) has seen its 2024 bottom-line estimates improve from a loss of 59 cents per share to earnings of 34 cents per share in the past 60 days [10] - CSTL's shares have surged 34 9% in the past year, and its earnings have beaten estimates in each of the trailing four quarters, with an average surprise of 172 72% [10] - Spero Therapeutics (SPRO) has seen its 2024 loss per share estimates narrow from $1 59 to $1 29 and its 2025 loss per share estimates narrow from $1 54 to 79 cents in the past 60 days [8] - SPRO's shares have lost 26 5% in the past year, and its earnings have beaten estimates in two of the trailing four quarters, with an average surprise of 94 42% [8] - CytomX Therapeutics (CTMX) has seen its 2024 loss per share estimates narrow from 29 cents to 5 cents and its 2025 loss per share estimates narrow from 56 cents to 35 cents in the past 60 days [3] - CTMX's shares have lost 34 9% in the past year, and its earnings have beaten estimates in two of the trailing four quarters, with an average surprise of 115 70% [3] Zacks Rankings - Arcutis currently carries a Zacks Rank 3 (Hold) [2] - Castle Biosciences (CSTL) and Spero Therapeutics (SPRO) sport a Zacks Rank 1 (Strong Buy), while CytomX Therapeutics (CTMX) carries a Zacks Rank 2 (Buy) [12]

Industry Overview - The drug and biotech sector experienced a turbulent year in 2024, starting strong but losing momentum in the second half due to disappointing third-quarter earnings, reduced guidance, and pipeline setbacks [1] - Despite challenges, the demand for cutting-edge medical innovations ensures the sector remains a focal point for investors [1] - Innovation continues to be a key growth driver, particularly in high-potential areas like obesity and oncology treatments [19] - The sector's robust fundamentals and expectations of strong M&A activity in 2025 indicate a promising outlook [19] Arcutis Biotherapeutics (ARQT) - Zoryve witnessed strong uptake, with Arcutis recording product revenues of $97 million in the first nine months of 2024, up more than 500% from the year-ago quarter [2] - The stock price rally was driven by FDA approval of Zoryve cream 0.15% for mild to moderate atopic dermatitis (AD) in July 2024 [15][16] - Arcutis plans to submit an sNDA for Zoryve cream 0.05% to treat mild to moderate AD in children two to five years old and has another sNDA for Zoryve foam 0.3% under FDA review for scalp and body psoriasis [17] - Shares of Arcutis have shot up 364.1% year-to-date compared with the industry's 12.8% decline [13] Mesoblast Limited (MESO) - Shares of Mesoblast have skyrocketed 673.6% year-to-date compared with the industry's 12.8% decline [4] - The stock price rally was driven by FDA approval of remestemcel-L (Ryoncil) for steroid-refractory acute graft versus host disease (SR-aGVHD) in children [6] - Mesoblast is expanding Ryoncil's label to include adult patients with SR-aGVHD and evaluating it for inflammatory bowel disease indications [7] - The FDA supports an accelerated approval pathway for rexlemestrocel-L in patients with end-stage ischemic heart failure with reduced ejection fraction (HFrEF) [8] - Estimates for MESO's 2025 loss per share have narrowed from 57 cents to 52 cents in the past 60 days [20] Monopar Therapeutics (MNPR) - Shares of Monopar have gained 1196.3% year-to-date compared with the industry's 12.8% decline [24] - The stock price rally was fueled by a licensing agreement with AstraZeneca for ALXN-1840, an investigational oral medicine for Wilson disease [25] - Monopar is focusing on developing ALXN-1840 for patients with more severe Wilson disease symptoms and evaluating several other candidates for various oncology indications [9][18] - Estimates for MNPR's 2025 loss per share have narrowed from $1.82 to $1.48 in the past 60 days [23] Kodiak Sciences (KOD) - Shares of Kodiak have rallied 224.7% year-to-date compared with the industry's 12.8% decline [12] - Kodiak is advancing KSI-501 into phase III development for wet AMD and has rebooted the development program of tarcocimab following positive phase III results from the GLOW study [10][12] - The company initiated the GLOW2 study in late 2023 to further investigate tarcocimab for diabetic retinopathy (DR) [12] - Estimates for KOD's 2025 loss per share have narrowed from $3.90 to $3.82 in the past 60 days [28]

Core Message - ZORYVE cream 0.05% demonstrated meaningful disease clearance and rapid itch reduction in pivotal trials, with a favorable safety profile for up to 56 weeks of treatment [1] - The sNDA submission for ZORYVE cream 0.05% targets mild to moderate atopic dermatitis (AD) in children aged 2 to 5, addressing a significant unmet need in pediatric dermatology [1][2] Clinical Trial Results - In the INTEGUMENT-PED Phase 3 trial, 25.4% of children treated with roflumilast cream 0.05% achieved vIGA-AD Success at Week 4, compared to 10.7% in the vehicle group (P<0.0001) [3] - Significant improvements in itch reduction were observed as early as Week 1, with 35.3% of children achieving a four-point reduction in WI-NRS at Week 4 (vs. 18.0% for vehicle-treated children) [3] - The safety profile in 2- to 5-year-old pediatric subjects was consistent with that observed in adults and older pediatric subjects, with mild adverse events such as upper respiratory tract infection, diarrhea, and vomiting [4] Market and Patient Population - Approximately 1.8 million children aged 2 to 5 in the United States are topically treated for atopic dermatitis, highlighting the potential market size for ZORYVE cream 0.05% [1] - Pediatric AD significantly impacts the quality of life for both children and their caregivers, emphasizing the need for effective and safe treatment options [2] Company and Product Background - Arcutis Biotherapeutics is a commercial-stage biopharmaceutical company focused on immuno-dermatology, with a growing portfolio of FDA-approved products [11] - ZORYVE cream 0.3% is approved for plaque psoriasis in patients aged 6 and older, while ZORYVE cream 0.15% is approved for mild to moderate AD in the same age group [6][7] - The company’s dermatology development platform includes multiple clinical programs targeting inflammatory dermatological conditions such as psoriasis, AD, and alopecia areata [11]

Technical Analysis - ARQT's 50-day simple moving average broke above its 200-day moving average, forming a "golden cross," a bullish technical indicator [1] - The golden cross consists of three stages: price bottoming out, short-term moving average crossing above long-term moving average, and maintaining upward momentum [1] - ARQT has gained 34.5% over the past four weeks [1] Earnings Outlook - No earnings estimate cuts for the current quarter, with 3 upward revisions in the past 60 days [2] - Zacks Consensus Estimate has increased, indicating a positive earnings outlook [2] Investment Potential - ARQT currently holds a 2 (Buy) rating on the Zacks Rank, suggesting potential for a breakout [1] - The combination of technical indicators and positive earnings revisions strengthens the bullish case for ARQT [1][2]