Summary of Arcutis Biotherapeutics FY Conference Call Company Overview - **Company**: Arcutis Biotherapeutics (NasdaqGS:ARQT) - **Focus**: Development and commercialization of dermatological therapies, particularly advanced topical treatments Industry Insights - **Market Dynamics**: The topical dermatology market has been historically dominated by topical steroids, which have been the standard of care for inflammatory skin conditions for over 70 years. Despite advancements in biologics and systemic therapies, topicals remain prevalent due to their effectiveness and cost-effectiveness [3][4][5] - **Market Shift**: There is a growing recognition among dermatologists regarding the safety issues associated with topical steroids, leading to a shift towards advanced topical therapies like Zoryve. This shift is expected to continue as more dermatologists become aware of the risks associated with steroids [4][5] Key Product Insights - **Zoryve**: - Zoryve has seen a dramatic increase in usage, with a 50% growth in volume year-over-year [5] - The company projects a market share of 15-20% for Zoryve, which is considered achievable [5] - Zoryve has high-quality coverage, with about 80% of patients having access through a single step, typically a generic steroid [9] - The product is positioned well in Medicaid, with over half of recipients having access without significant barriers [9] Financial Performance - **Quarterly Growth**: The third quarter reported a 22% growth quarter-over-quarter, with 13% attributed to volume and 9% to price adjustments [15] - **Cash Flow Breakeven**: The company expects to achieve cash flow breakeven starting in Q4 2025, with a focus on reinvesting in Zoryve and its lifecycle management [21] Future Opportunities - **Pediatric Market**: Recent approvals for pediatric indications (ages 2-5) present a significant market opportunity, as a large percentage of atopic dermatitis sufferers are children [11][12] - **Research and Development**: Arcutis is exploring new indications for Zoryve, including studies in nail psoriasis and vitiligo, based on positive clinician feedback [25][26] - **Pipeline Expansion**: The company is also pursuing a biologic (CD200R) for atopic dermatitis, addressing unmet needs in systemic therapies [27][28] Strategic Considerations - **Pricing Strategy**: Arcutis adopted a lower pricing strategy compared to competitors to enhance market access and minimize patient copays, particularly in the Medicare and Medicaid spaces [8][9] - **Business Development**: The company is focused on in-licensing molecules with large markets and high unmet needs, avoiding high-risk drug discovery [30][32] Intellectual Property - **Patent Portfolio**: Arcutis holds 23 issued U.S. patents covering Zoryve formulations, with protection extending through 2037 and beyond for specific formulations [41][42] Conclusion - Arcutis Biotherapeutics is positioned to capitalize on the ongoing shift in the dermatology market towards advanced topical therapies, with a strong product pipeline and strategic focus on market access and pediatric opportunities. The company aims to sustain growth while achieving cash flow breakeven and exploring new indications for its products.

Core Viewpoint - Arcutis Biotherapeutics, Inc. (ARQT) shows significant potential for upside, with a current stock price of $24.01 and a mean price target of $30.38, indicating a 26.5% upside potential [1]. Price Targets - The average of eight short-term price targets ranges from a low of $29.00 to a high of $32.00, with a standard deviation of $1.19, suggesting a relatively high agreement among analysts [2]. - The lowest estimate indicates a potential increase of 20.8%, while the most optimistic estimate points to a 33.3% upside [2]. Analyst Sentiment - Analysts are increasingly optimistic about ARQT's earnings prospects, as indicated by a positive trend in earnings estimate revisions, which has historically correlated with stock price movements [4][11]. - Over the last 30 days, three earnings estimates have been revised higher, leading to a 46.5% increase in the Zacks Consensus Estimate for the current year [12]. 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, which further supports the stock's potential upside [13]. Conclusion on Price Targets - While the consensus price target may not be a reliable indicator of the magnitude of ARQT's potential gains, the direction implied by these targets appears to be a useful guide for further research [14].

Core Insights - Arcutis Biotherapeutics announced the publication of Phase 2 long-term safety data for ZORYVE foam, indicating it is safe, well-tolerated, and effective for treating seborrheic dermatitis for up to 52 weeks [1][8] - ZORYVE foam was approved by the FDA in December 2023 for seborrheic dermatitis and in 2025 for scalp and body plaque psoriasis [1][8] Study Details - The Phase 2 open-label safety trial involved 400 participants aged 12 years and older with moderate to severe seborrheic dermatitis, applying ZORYVE foam once daily [2][3] - The primary endpoint was safety, with 32.5% of participants reporting treatment-emergent adverse events (TEAEs), the most common being COVID-19 (3.8%) and headache (3.3%) [3][4] Efficacy Results - Durable efficacy was observed, with 52.2% of participants achieving an Investigator Global Assessment (IGA) of Clear (0) at Week 52 [5] - At Week 4, 56.4% achieved IGA of Clear or Almost Clear (0 or 1), increasing to 80.4% by Week 52 [5] - Significant improvement in itch was noted, with 71.3% of participants with baseline Worst Itch Numeric Rating Scale (WI-NRS) ≥4 achieving a clinically significant response at Week 24 [6] Mechanism and Recognition - ZORYVE foam is the first topical treatment for seborrheic dermatitis approved in 20 years, utilizing a new mechanism of action targeting phosphodiesterase type 4 (PDE4) [7][9] - ZORYVE has received multiple accolades, including the "2025 Best of Beauty Breakthrough Award" from Allure [10]

Company Performance - Arcutis Biotherapeutics, Inc. (ARQT) shares have increased by 17.3% over the past month and reached a new 52-week high of $27.08 [1] - The stock has gained 78.9% since the beginning of the year, outperforming the Zacks Medical sector's 4.3% gain and the Zacks Medical - Biomedical and Genetics industry's 12% return [1] Earnings and Revenue - The company has a strong record of positive earnings surprises, having beaten earnings consensus estimates in the last four quarters [2] - In the latest earnings report on October 28, 2025, Arcutis reported EPS of $0.06, surpassing the consensus estimate of -$0.1, and beat the revenue estimate by 12.32% [2] - For the current fiscal year, Arcutis is expected to post earnings of -$0.24 per share on revenues of $360.24 million, reflecting a 79.31% change in EPS and an 83.29% change in revenues [3] - For the next fiscal year, the expected earnings are $0.41 per share on revenues of $439.41 million, indicating a year-over-year change of 273.61% in EPS and 21.97% in revenues [3] Valuation Metrics - Arcutis has a Value Score of D, while its Growth and Momentum Scores are both A, resulting in a VGM Score of B [6] - The stock currently holds a Zacks Rank of 2 (Buy), supported by a solid earnings estimate revision trend [7][8] Industry Comparison - The Medical - Biomedical and Genetics industry is positioned in the top 39% of all industries, suggesting favorable conditions for both Arcutis and its peer, Exact Sciences Corporation (EXAS) [11] - Exact Sciences has a Zacks Rank of 1 (Strong Buy) and has shown strong earnings performance, beating consensus estimates by 1,200% [10]

Core Insights - The biotech sector is experiencing significant momentum, with many clinical-stage and commercial biopharma stocks reaching new 52-week highs due to breakthrough trial data, strategic deals, and earnings surprises [1] Company Summaries - **Metsera Inc. (MTSR)**: A clinical-stage biopharmaceutical company focused on developing hormone analog peptides for obesity and related metabolic diseases. Recently, Novo Nordisk made a $9 billion unsolicited acquisition proposal, which Metsera's board considers superior to its existing agreement with Pfizer [2][3]. Metsera announced positive Phase 2b results for its GLP-1 receptor agonist MET-097i, showing up to 14.1% weight loss after 28 weeks, supporting Phase 3 initiation in late 2025 [4]. The stock rose from $32.35 to a 52-week high of $66.10, a gain of 104.3% [5]. - **Indivior Plc (INDV)**: Develops buprenorphine-based therapies for opioid dependence. The company reported Q3 net income of $42 million, up from $22 million a year ago, with adjusted earnings of $93 million, exceeding Wall Street's expectations [6][7]. The stock increased from $20.86 to a 52-week high of $30.55, reflecting a 46.5% gain [7]. - **Insmed Inc. (INSM)**: Focused on therapies for serious and rare diseases, Insmed reported a Q3 net loss of $370 million but saw net product revenue rise to $142.3 million from $93.4 million last year [8][9]. The company raised its full-year 2025 revenue guidance for ARIKAYCE to $420 million - $430 million, indicating 15% - 18% growth year-over-year [10]. The stock surged from $76.54 to a 52-week high of $194.70, marking a 154.4% gain [10]. - **Ventyx Biosciences Inc. (VTYX)**: A clinical-stage biotech company developing therapies for autoimmune and neurodegenerative diseases. Ventyx reported positive Phase 2 results for its NLRP3 inhibitor VTX3232, showing strong safety and tolerability [11][13]. The stock rose from $3.01 to a 52-week high of $8.52, a gain of over 183% [14]. - **Inhibrx Biosciences Inc. (INBX)**: Focuses on oncology and rare diseases, announcing positive topline results from its ChonDRAgon study for ozekibart in chondrosarcoma [15]. The stock increased from $18.35 to a 52-week high of $83.78, representing a gain of 356.6% [16]. - **ABIVAX Société Anonyme (ABVX)**: Developing therapies for chronic inflammatory diseases, ABIVAX presented positive Phase 3 data for obefazimod in ulcerative colitis [17]. The stock rose from $7.83 to an all-time high of $106.73, marking a significant gain of 1263% [18]. - **Arrowhead Pharmaceuticals Inc. (ARWR)**: Developing RNAi-based therapies, Arrowhead finalized a licensing agreement with Novartis for ARO-SNCA, with financial terms including a $200 million upfront payment [19][20][21]. The stock increased from $29.70 to a 52-week high of $43.33, representing a gain of over 45% [21]. - **Kodiak Sciences Inc. (KOD)**: Focused on retinal diseases, Kodiak announced positive Phase 1b data for KSI-101, showing significant vision improvements [22][23][24]. The stock climbed from $8.98 to a 52-week high of $21.17, delivering a 135.7% gain [22]. - **Arcutis Biotherapeutics Inc. (ARQT)**: Focused on dermatological treatments, Arcutis reported Q3 net income of $7.4 million, a turnaround from a net loss last year, with revenue up 122% year-over-year [25][26]. The stock rose from $14.99 to a 52-week high of $27.08, representing a gain of over 80% [27]. - **Maze Therapeutics Inc. (MAZE)**: Developing precision therapies for various diseases, Maze announced positive Phase 1 results for MZE782 and secured $150 million in a private placement [28][29]. The stock rose from $11.21 to a new 52-week high of $34.29, returning a gain of 206% [29]. - **Supernus Pharmaceuticals Inc. (SUPN)**: Focused on CNS disorders, Supernus is expected to report Q3 earnings of $0.82 per share and revenue of $180.22 million [30][31]. The stock increased from $38.21 to a 52-week high of $57.65, representing a gain of over 50% [31].

Core Viewpoint - Arcutis Biotherapeutics, Inc. (ARQT) has been upgraded to a Zacks Rank 1 (Strong Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][4]. Earnings Estimates and Stock Performance - The Zacks rating system is based on changes in a company's earnings estimates, which are tracked through the Zacks Consensus Estimate [2]. - A strong correlation exists between revisions in earnings estimates and near-term stock price movements, making the Zacks rating system valuable for investors [3][5]. - The recent upgrade for Arcutis Biotherapeutics reflects an improvement in its underlying business, which is expected to drive the stock price higher [6]. Earnings Estimate Revisions - Analysts have raised their earnings estimates for Arcutis Biotherapeutics, with the Zacks Consensus Estimate increasing by 19.9% over the past three months [9]. - The company is projected to earn -$0.44 per share for the fiscal year ending December 2025, indicating no year-over-year change [9]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [8]. - Only the top 5% of Zacks-covered stocks receive a "Strong Buy" rating, positioning Arcutis Biotherapeutics among the best candidates for market-beating returns in the near term [10][11].

Core Insights - Arcutis Biotherapeutics, Inc. is facing challenges in capital efficiency, as indicated by its financial metrics, particularly the comparison between its Return on Invested Capital (ROIC) and its Weighted Average Cost of Capital (WACC) [1][2] Financial Metrics - Arcutis has a ROIC of -14.38% and a WACC of 13.83%, resulting in a ROIC to WACC ratio of -1.04, indicating insufficient returns to cover its cost of capital [2][5] - In comparison, Keros Therapeutics, Inc. has a ROIC of 0.03% and a WACC of 8.14%, leading to a ROIC to WACC ratio of 0.0037 [3] - Crinetics Pharmaceuticals, Inc. and Revolution Medicines, Inc. have negative ROICs of -34.46% and -39.71% respectively, with WACCs of 5.23% and 9.58%, resulting in ROIC to WACC ratios of -6.59 and -4.14, indicating even less efficient capital use compared to Arcutis [3] - Phathom Pharmaceuticals, Inc. has a significantly negative ROIC of -149.31% against a WACC of 8.60%, resulting in a ROIC to WACC ratio of -17.37, highlighting severe inefficiency in capital use [4][5] - Black Diamond Therapeutics, Inc. stands out with a positive ROIC of 2.99% and a WACC of 16.85%, achieving a ROIC to WACC ratio of 0.18, indicating the most efficient capital use among peers [4][5]

Core Insights - Grifols (GRFS) is currently outperforming its peers in the Medical group, with a year-to-date gain of approximately 26.2% compared to the average gain of 4% for Medical stocks [4] - The Zacks Rank system indicates a positive outlook for Grifols, currently holding a Zacks Rank of 2 (Buy), with a 1% increase in the consensus earnings estimate over the past 90 days [3] Company Performance - Grifols is part of the Medical - Drugs industry, which consists of 145 companies and is ranked 90 in the Zacks Industry Rank, with an average gain of 7.3% year-to-date [5] - The stock's performance is significantly better than the industry average, indicating strong relative strength within its sector [5] Comparison with Peers - Arcutis Biotherapeutics, Inc. (ARQT) is another standout in the Medical sector, having returned 81.6% year-to-date, with a Zacks Rank of 1 (Strong Buy) and a 19.9% increase in the consensus EPS estimate over the past three months [4][5] - The Medical group is currently ranked 5 within the Zacks Sector Rank, which evaluates the strength of 16 different groups based on the average Zacks Rank of individual stocks [2]

Core Insights - Arcutis Biotherapeutics launched the "Free to Be Me" awareness campaign to highlight the emotional and physical challenges faced by approximately 36 million Americans with inflammatory skin diseases, including atopic dermatitis and seborrheic dermatitis [1][2][14] - The campaign features actress Tori Spelling and her daughter, who share their personal experiences managing skin conditions with the FDA-approved treatment ZORYVE® (roflumilast) [2][3][4] Company Overview - Arcutis Biotherapeutics is a commercial-stage biopharmaceutical company focused on innovations in immuno-dermatology, with a commitment to addressing the needs of individuals with immune-mediated dermatological diseases [21] - ZORYVE is the number one prescribed branded topical therapy for atopic dermatitis, seborrheic dermatitis, and plaque psoriasis, backed by robust clinical evidence from eight pivotal trials involving approximately 4,200 participants [12][10] Product Information - ZORYVE cream 0.15% is indicated for treating atopic dermatitis in adults and children aged 6 and older, showing a 31% rate of achieving clear or almost clear skin at 4 weeks in clinical trials [6][10] - ZORYVE foam 0.3% is indicated for seborrheic dermatitis in adults and children aged 9 and older, with 77% of users achieving clear or almost clear skin after 8 weeks of treatment [7][10] Clinical Evidence - Clinical trials demonstrated that ZORYVE cream and foam are safe and well-tolerated, with common side effects including headache, nausea, and application site pain [10][18] - The American Academy of Dermatology issued a strong recommendation for ZORYVE cream 0.15% for adult patients with mild to moderate atopic dermatitis, reflecting its clinical significance [13] Campaign Objectives - The "Free to Be Me" campaign aims to empower individuals with inflammatory skin conditions to engage in open conversations with healthcare providers about effective treatment options [14][8] - Tori Spelling's involvement in the campaign seeks to break the stigma surrounding skin conditions and encourage others to take control of their skin health [8][3]

Core Insights - Arcutis Biotherapeutics has launched ZORYVE® (roflumilast) cream 0.05% for treating mild to moderate atopic dermatitis in children aged 2 to 5 years in the U.S. [1][4] Product Overview - ZORYVE cream 0.05% is a once-daily, steroid-free topical treatment that offers long-term disease control without restrictions on duration of use [2][3] - Clinical trials showed ZORYVE cream 0.05% achieved significant clearance of atopic dermatitis signs and symptoms, along with meaningful improvement in itch [2][3] - The product is now available in pharmacies and is undergoing review by pharmacy benefit managers for coverage [3] Market Context - Atopic dermatitis is a prevalent chronic skin condition in young children, affecting approximately 9.6 million children in the U.S. [7] - The launch of ZORYVE cream 0.05% expands treatment options for a younger pediatric population, addressing a significant unmet need for safe and effective long-term treatments [3][4] Company Commitment - Arcutis is focused on ensuring predictable access to the ZORYVE portfolio through programs like the ZORYVE Direct Program, which assists patients with adherence and reduces out-of-pocket costs [4] - The company also offers the Arcutis Cares™ patient assistance program for uninsured or underinsured patients [4] Regulatory Approval - The U.S. FDA approved ZORYVE cream 0.05% for treating mild to moderate atopic dermatitis in children aged 2 to 5 years on October 6, 2025 [4][10] Recognition and Awards - ZORYVE has received multiple awards, including the "2025 Best of Beauty Breakthrough Award" from Allure, and has been recognized by the National Psoriasis Foundation and the American Academy of Dermatology [8]