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Arcutis Biotherapeutics, Inc. (ARQT): Business Model Canvas [Dec-2025 Updated] |
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You're digging into Arcutis Biotherapeutics, Inc. right now, trying to map out exactly how this company is turning its pipeline into profit, and honestly, the numbers from Q3 2025 show they are hitting an inflection point faster than many expected. With Net Product Revenue hitting $99.2 million that quarter, driven by that key steroid-free, once-daily ZORYVE franchise, the path to cash flow breakeven looks clearer, maybe even by Q4 2025. This Business Model Canvas breaks down the mechanics: it's a tight integration of a specialized dermatology sales force, strategic co-promotion with Kowa, and a cost structure where SG&A hit $62.4 million against that strong revenue base. It's a classic specialty pharma playbook, but the speed is the story here. You need to see the details below to understand the levers they are pulling.
Arcutis Biotherapeutics, Inc. (ARQT) - Canvas Business Model: Key Partnerships
You're looking at the external relationships Arcutis Biotherapeutics, Inc. uses to get its value proposition-innovative topical treatments-to market and advance its pipeline. These partnerships are key to extending reach beyond the core dermatology segment and managing development costs.
Co-promotion with Kowa Pharmaceuticals for primary care reach
Arcutis Biotherapeutics, Inc. entered into a co-promotion agreement with Kowa Pharmaceuticals America, Inc. in July 2024. Kowa leverages its primary care sales force, which consists of over 200 people, to exclusively market and promote ZORYVE to primary care practitioners and pediatricians in the United States for all FDA-approved indications. This arrangement is set to last until at least July 2029. The goal is to access a large portion of the estimated 7.4 million patients treated for conditions like plaque psoriasis, seborrheic dermatitis, and atopic dermatitis outside of dermatology offices. Kowa receives a commission based on net sales attributed to their promotion, and they promote ZORYVE in the priority position. The commercialization efforts are clearly driving results; Arcutis Biotherapeutics, Inc. reported Q3 2025 net product revenue for ZORYVE of $99.2 million.
Licensing agreement with AstraZeneca for roflumilast topical rights
Arcutis Biotherapeutics, Inc. holds exclusive worldwide rights to all topical dermatological uses of roflumilast, the active ingredient in ZORYVE, through a licensing agreement with AstraZeneca AB, originally entered into in July 2018. Arcutis has sole responsibility for development, regulatory, and commercialization activities for these AZ-Licensed Products in the Dermatology Field. This partnership triggered a financial event in early 2025; Arcutis Biotherapeutics, Inc. made a $10.0 million cash milestone payment to AstraZeneca in Q1 2025 after ZORYVE reached a sales milestone of $250 million. The company's 2026 full-year net product sales guidance is $455-$470 million.
Manufacturing partners for ZORYVE production (Arcutis maintains sole responsibility)
While Arcutis Biotherapeutics, Inc. maintains sole responsibility for development, regulatory, and commercialization activities for the roflumilast topical products, the company utilizes external manufacturing support. A Supply and Manufacturing Agreement with DPT Laboratories, Ltd. is on record. The direct cost associated with the growing sales volume is reflected in the Cost of Sales, which was $8.7 million for the quarter ended September 30, 2025, up from $5.5 million for the corresponding period in 2024 due to increasing ZORYVE sales.
Clinical research organizations (CROs) for pipeline trials
Arcutis Biotherapeutics, Inc. focuses on biologically validated targets to offer development on a shorter timeline and at a lower overall cost of development, which often involves the use of CROs for trial execution. The company is advancing its pipeline, including ARQ-234, for which it submitted an Investigational New Drug (IND) application in July 2025. Furthermore, Arcutis initiated the INTEGUMENT-INFANT study to evaluate ZORYVE cream 0.05% in infants as young as 3 months to less than 2 years with atopic dermatitis.
License with Jiangsu Hengrui Medicine for ARQ-252 development
Arcutis Biotherapeutics, Inc. secured an exclusive license for the active pharmaceutical ingredient in ARQ-252, a Janus kinase type 1 (JAK1) inhibitor, from Jiangsu Hengrui Medicine Co., Ltd. (Hengrui) in January 2018, exercising the option in December 2019. This license covers all topical dermatological uses in the United States, Canada, Europe, and Japan. The composition of matter patents in the United States associated with this license do not begin to expire until 2033.
Key Partnership Summary
| Partner Entity | Asset/Product Focus | Key Term/Metric | Status/Date Reference |
| Kowa Pharmaceuticals America, Inc. | ZORYVE Co-promotion (Primary Care/Pediatrics) | Agreement until at least July 2029 | July 2024 agreement |
| AstraZeneca AB | Exclusive Worldwide Topical Roflumilast Rights (ZORYVE) | Milestone Payment of $10.0 million paid upon $250 million sales threshold | Milestone incurred in Q1 2025 |
| Jiangsu Hengrui Medicine Co., Ltd. | ARQ-252 (JAK1 Inhibitor) Topical Rights | US Composition of Matter Patents expire starting 2033 | Option exercised December 2019 |
| External Manufacturers (e.g., DPT Laboratories, Ltd.) | ZORYVE Production | Q3 2025 Cost of Sales: $8.7 million | Q3 2025 Financials |
The company's cash position as of September 30, 2025, was $191.4 million.
Arcutis Biotherapeutics, Inc. (ARQT) - Canvas Business Model: Key Activities
You're looking at the core engine driving Arcutis Biotherapeutics, Inc.'s current value, which is heavily concentrated on making ZORYVE a dominant force in dermatology. The key activities are all about execution on the commercial front while simultaneously advancing the pipeline to secure future revenue streams.
Commercialization and marketing of the ZORYVE franchise
The primary activity is driving adoption and sales for the ZORYVE portfolio across its approved indications: plaque psoriasis, atopic dermatitis, and seborrheic dermatitis. This involves significant Selling, General, and Administrative (SG&A) investment to support the sales force, including the co-promotion efforts with Kowa Pharmaceuticals, Inc. which began in July 2024 to target primary care and pediatricians.
The results of this activity are clear in the top-line numbers. For the third quarter of 2025, Arcutis Biotherapeutics, Inc. reported net product revenue for the ZORYVE franchise of $99.2 million, which was a 122% increase compared to the third quarter of 2024. This represented sequential growth of 22% over the second quarter of 2025. The company has a long-term goal to drive potential peak ZORYVE sales to between $2.6 billion and $3.5 billion per annum, based on capturing an assumed 15%-20% share of the topical corticosteroid market volume, where 17 million prescriptions are written annually for ZORYVE-approved indications.
Here's the breakdown of the Q3 2025 net product revenue:
| ZORYVE Product Formulation | Q3 2025 Net Revenue (USD Millions) |
| ZORYVE foam 0.3% | $49.8 million |
| ZORYVE cream 0.3% | $30.5 million |
| ZORYVE cream 0.15% | $18.9 million |
SG&A expenses for the third quarter of 2025 were $62.4 million, up from $58.8 million in the same period last year, primarily due to these continued commercialization investments.
Regulatory filings for new indications (e.g., pediatric atopic dermatitis)
A critical ongoing activity is expanding the ZORYVE label to capture younger patient populations, which broadens the addressable market significantly. This requires careful management of clinical trials and timely regulatory submissions.
Key recent regulatory milestones include:
- ZORYVE cream 0.05% received U.S. Food and Drug Administration (FDA) approval in October 2025 for atopic dermatitis in children down to 2 years of age.
- The company planned to launch this ZORYVE cream 0.05% indication for children ages 2 to 5 by the end of October 2025.
- In September 2025, a supplemental New Drug Application (sNDA) was submitted to the FDA to expand ZORYVE cream 0.3% for plaque psoriasis in children down to age 2.
- The INTEGUMENT-INFANT Phase 2 study was initiated in June 2025 to evaluate ZORYVE cream 0.05% in infants from 3 months to less than 2 years with atopic dermatitis.
- ZORYVE foam 0.3% received FDA approval in May 2025 for plaque psoriasis of the scalp and body in patients 12 years and older, with sales commencing in June 2025.
Research and development (R&D) for pipeline assets like ARQ-234
Arcutis Biotherapeutics, Inc. dedicates resources to advancing its pipeline beyond the current ZORYVE franchise, focusing on biologically validated targets. This activity is reflected in the quarterly R&D spend.
For the third quarter of 2025, Research and Development (R&D) expenses totaled $19.6 million, consistent with the $19.5 million reported in the third quarter of 2024. This spend supports pipeline assets like ARQ-234, a CD200 Receptor (CD200R) agonist being developed for atopic dermatitis.
The key activity milestones for ARQ-234 include:
- The Investigational New Drug (IND) application for ARQ-234 was submitted to the FDA in July 2025.
- The company anticipates commencing a Phase 1 study for ARQ-234 in the first quarter of 2026.
Maintaining payor access and favorable Gross-to-Net (GTN) pricing
Securing favorable reimbursement terms is crucial, as it directly impacts the realized net price of ZORYVE. Favorable GTN rates mean a higher percentage of the gross sales translates into actual cash received.
The improved GTN pricing was cited as a driver for the sequential revenue growth in Q3 2025. While Q1 2025 saw a temporarily higher GTN due to deductible resets, the rate was trending back toward the 50% range. As of Q2 2025, the company projected cash breakeven with GTN reimbursement rates at approximately ~50%. As of Q1 2025, all three largest national Pharmacy Benefit Managers (PBMs) were covering the entire ZORYVE portfolio, and Medicaid coverage had expanded to approximately 53% of state lives.
Manufacturing and supply chain management
This activity ensures the product is available to meet growing demand while managing the associated costs. The efficiency of this operation is measured by the gross margin.
The Cost of Sales for the third quarter of 2025 was $8.7 million, up from $5.5 million in the third quarter of 2024, reflecting the increasing ZORYVE sales volume. This cost structure supported an impressive gross profit margin of 89.1% in Q3 2025. Finance: draft 13-week cash view by Friday.
Arcutis Biotherapeutics, Inc. (ARQT) - Canvas Business Model: Key Resources
The Key Resources for Arcutis Biotherapeutics, Inc. center on its approved product portfolio, the associated intellectual property moat, the commercial engine built to support it, and the current financial backing.
Proprietary drug: ZORYVE (roflumilast) in cream and foam formulations
The core resource is the ZORYVE franchise, which has multiple approved strengths and formulations driving significant revenue growth. For the quarter ended September 30, 2025, net product revenues for ZORYVE totaled $99.2 million.
Here's the quick math on the ZORYVE product mix for Q3 2025:
| ZORYVE Formulation | Net Product Revenue (Q3 2025) |
| ZORYVE topical foam 0.3% | $49.8 million |
| ZORYVE cream 0.3% | $30.5 million |
| ZORYVE cream 0.15% | $18.9 million |
Additionally, ZORYVE cream 0.05% received U.S. Food and Drug Administration (FDA) approval in October 2025 for the treatment of atopic dermatitis in children down to 2 years of age.
Intellectual property and patents on topical roflumilast compositions
Protecting the ZORYVE franchise is a key resource, secured through patents. The company obtained one new U.S. patent in Q3 2025 related to topical roflumilast foam compositions.
Specialized dermatology sales force and commercial infrastructure
The commercial capability is evidenced by the investment in sales and marketing activities and strategic partnerships:
- Selling, general, and administrative (SG&A) expenses for the quarter ended September 30, 2025, were $62.4 million, driven by increased sales and marketing and personnel-related expenses.
- The company has a co-promotion agreement with Kowa Pharmaceuticals, Inc., initiated in July 2024, to leverage Kowa's primary care sales force to exclusively market and promote ZORYVE to primary care practitioners and pediatricians in the United States.
- The company was named to Fortune Best Workplaces in BioPharma™ 2025 list for the fourth consecutive year.
Cash and marketable securities of $191.4 million (as of September 30, 2025)
Liquidity provides the runway for continued commercial execution and pipeline advancement. As of September 30, 2025, Arcutis Biotherapeutics, Inc. held $191.4 million in cash, cash equivalents, restricted cash, and marketable securities. This financial position supported the company achieving a net income of $7.4 million in Q3 2025.
Finance: draft 13-week cash view by Friday.
Arcutis Biotherapeutics, Inc. (ARQT) - Canvas Business Model: Value Propositions
You're looking at the core value Arcutis Biotherapeutics, Inc. is delivering to dermatologists and patients, which is clearly driving their recent financial success. The entire proposition centers on the ZORYVE franchise, a phosphodiesterase-4 (PDE4) inhibitor, offering a non-steroidal, convenient alternative for chronic inflammatory skin diseases.
Steroid-free, once-daily topical treatment for chronic skin diseases
The primary value is offering a steroid-free, once-daily topical treatment. This directly addresses the long-term safety concerns and application frequency issues associated with traditional topical corticosteroids. The market opportunity is substantial; Arcutis management pegs the long-term peak sales potential for the ZORYVE franchise at $2.6 billion to $3.5 billion annually, assuming they capture 15-20% of the entire topical corticosteroid market, where 17 million prescriptions are written by dermatology clinicians every year for ZORYVE-approved indications. This value proposition is translating directly to the bottom line, with Q3 2025 net product revenue for ZORYVE reaching $99.2 million, a 122% increase year-over-year. The company even achieved net income of $7.4 million in Q3 2025, a significant swing from a net loss of $41.5 million in Q3 2024.
Broad-spectrum utility in multiple conditions: psoriasis, AD, seborrheic dermatitis
Arcutis Biotherapeutics offers broad utility with ZORYVE across three major inflammatory dermatoses, which is a key differentiator. ZORYVE is now the number one prescribed branded topical therapy across these three conditions combined. The efficacy data supports this wide application:
- ZORYVE cream 0.15% for Atopic Dermatitis (AD) showed that 91.5% of patients experienced a measurable improvement in Eczema Area and Severity Index (EASI) at week 4.
- For AD, 69.2% of patients achieved a 50% decrease in EASI after four weeks, compared to 44.4% in the control group (p<0.0001).
- ZORYVE foam 0.3% for Seborrheic Dermatitis showed 79.5% achieved Investigator Global Assessment (IGA) Success at Week 8, versus 58.0% for vehicle.
Here's how the different ZORYVE formulations map to the approved indications as of late 2025:
| Product/Formulation | Indication | Approved Patient Age Group | Q3 2025 Revenue |
| ZORYVE cream 0.3% | Plaque Psoriasis (including intertriginous areas) | Adults and pediatric patients 6 years of age and older | $30.5 million |
| ZORYVE cream 0.15% | Mild to moderate Atopic Dermatitis | Adults and pediatric patients 6 years of age and older | $18.9 million |
| ZORYVE topical foam 0.3% | Seborrheic Dermatitis | Adult and pediatric patients 9 years of age and older | $49.8 million |
The foam formulation for seborrheic dermatitis generated the highest revenue in Q3 2025 at $49.8 million, showing strong adoption for that specific condition.
Formulations for hard-to-treat areas like the scalp (ZORYVE foam)
The development of ZORYVE topical foam 0.3% specifically addresses areas like the scalp, which is often challenging for creams to treat effectively. More than half of the nearly 9 million people in the U.S. with plaque psoriasis experience scalp involvement. For this specific use, the foam demonstrated rapid improvement in itch and signs/symptoms of psoriasis of the scalp and body when used as monotherapy. Specifically, 66.4% of individuals treated with ZORYVE foam achieved Scalp-Investigator Global Assessment (S-IGA) Success at Week 8.
Expanding treatment options for pediatric patients (ages 2+)
A critical value driver is the expansion into younger pediatric populations, moving beyond the initial approvals. This addresses a significant unmet need for safe, effective topicals in children. You see this expansion across two key indications:
- ZORYVE cream 0.05% received FDA approval in October 2025 for Atopic Dermatitis in children down to 2 years of age.
- The company submitted a supplemental New Drug Application (sNDA) to expand the ZORYVE cream 0.3% indication for plaque psoriasis to children ages 2 to 5, with a Prescription Drug User Fee Act (PDUFA) target action date set for June 29, 2026.
The data supporting the AD pediatric expansion showed improved quality of life and decreased impact on families for investigational ZORYVE cream 0.05% in children aged 2-5 years. The company is also evaluating ZORYVE cream 0.05% in infants as young as 3 months in a Phase 2 study (INTEGUMENT-INFANT) for atopic dermatitis.
Finance: Finance needs to model the impact of the $455-$470 million net product sales guidance for full-year 2026 against the current cash position of $191.4 million as of September 30, 2025.
Arcutis Biotherapeutics, Inc. (ARQT) - Canvas Business Model: Customer Relationships
You're focused on building deep relationships with the right prescribers to drive adoption of ZORYVE across its expanding indications. This requires significant investment in the commercial infrastructure, which is reflected in the operating expenses.
High-touch engagement via a dedicated dermatology sales team
The commercialization efforts for ZORYVE are directly supported by increased sales and marketing and personnel-related expenses within Selling, General, and Administrative (SG&A) costs. For the quarter ended September 30, 2025, SG&A expenses were $62.4 million, up from $58.8 million for the same period in 2024. This investment supports the team engaging the core dermatology specialty market.
The Serviceable Obtainable Market (SOM) for ZORYVE within the dermatology specialty is estimated at 8 million patients receiving topical prescriptions. As of the first quarter of 2025, ZORYVE cream 0.3% had been prescribed by over 18,000 unique prescribers. Arcutis Biotherapeutics, Inc. had 342 total employees as of September 30, 2025.
Here are some key commercial and market statistics as of late 2025:
| Metric | Value | Context/Date |
| Q3 2025 Net Product Revenue | $99.2 million | Quarter ended September 30, 2025 |
| Q3 2025 SG&A Expenses | $62.4 million | Driven by commercialization efforts |
| Total Employees | 342 | As of September 30, 2025 |
| Dermatology Specialty SOM | 8 million patients | Serviceable Obtainable Market |
| Total Topical Prescriptions (Derm) Annually | 17 million | Topical corticosteroid prescriptions written by dermatology clinicians in ZORYVE-approved indications |
Co-promotion outreach to non-specialist prescribers (PCPs, pediatricians)
The joint commercial strategy specifically targets high-volume non-specialist prescribers. The total universe of PCPs and pediatricians in the U.S. is over 0.5 million. The focus is on the top 30,000 of these providers, who account for nearly 1/3 of all prescriptions written in those segments.
Patient support and access programs (implied for specialty pharmaceuticals)
Access is supported by favorable reimbursement terms and dedicated patient assistance. As of Q1 2025, ZORYVE cream 0.15% had coverage secured with the three largest national PBMs. The growth in Q3 2025 net product revenue was partly attributed to reduced utilization of patient copay programs as patients progressed through their annual deductibles.
The Arcutis Cares Patient Assistance program supports patients who are uninsured or government insured and cannot afford their copayment. Eligibility for this program starts at 300% of the Federal Poverty Level, adjusted for family size.
- Reside in and be treated by a healthcare provider in the United States.
- Have a valid prescription for the Arcutis medicine consistent with the FDA-approved indication.
- Meet income guidelines, starting at 300% of the Federal Poverty Level.
Continuous medical education and scientific communication
Scientific communication is integrated into ongoing operational spending. For the quarter ended June 30, 2025, Research and Development (R&D) expenses included continued medical affairs investments to support medical education. R&D expenses for the quarter ended September 30, 2025, were $19.6 million. The company is also pursuing new indications, such as initiating the INTEGUMENT-INFANT study for ZORYVE cream 0.05% in infants aged 3 months to 24 months.
Arcutis Biotherapeutics, Inc. (ARQT) - Canvas Business Model: Channels
You're looking at how Arcutis Biotherapeutics, Inc. gets ZORYVE into the hands of patients and doctors as of late 2025. The channel strategy clearly splits focus between specialist and primary care markets, which is smart for maximizing reach for a product like ZORYVE.
Direct sales force to U.S. dermatologists and specialists
Arcutis Biotherapeutics, Inc. maintains direct control over reaching the core specialists. This team focuses on dermatologists and other dermatology clinicians who are the primary prescribers for chronic inflammatory skin diseases. The investment in this channel is reflected in the Selling, general, and administrative (SG&A) expenses, which hit $62.4 million for the quarter ended September 30, 2025. This SG&A increase year-over-year was primarily driven by increased sales and marketing and personnel-related expenses tied to ZORYVE commercialization efforts. As of late 2025, the company reports a total employee count of 342, a significant portion of whom support this direct commercial effort.
The effectiveness of this specialist channel, combined with the broader strategy, is evident in the prescription volume:
- Weekly prescriptions on a rolling 4-week average reached a new record high of over 17,000 scripts as of Q3 2025.
- ZORYVE prescriptions increased by 13% compared to Q2 2025.
- The company is targeting the 17 million prescriptions written annually by dermatology clinicians for ZORYVE-approved indications.
Kowa's sales force to U.S. primary care and pediatric offices
To expand beyond dermatology specialists, Arcutis Biotherapeutics, Inc. uses a co-promotion agreement with Kowa Pharmaceuticals America, Inc. Kowa leverages its established primary care sales force to market and promote ZORYVE to primary care practitioners and pediatricians. This partnership, which began promotion in late September 2024, is designed to access the large patient population treated outside of dedicated dermatology offices. The agreement is exclusive for Kowa in the primary care and pediatrics space and runs until at least July 2029.
The channel split means Kowa targets a different set of prescribers, aiming to capture patients managed by general practitioners. This dual-force approach helps Arcutis Biotherapeutics, Inc. cover the total addressable market more comprehensively.
Specialty and retail pharmacy distribution networks
Getting the product dispensed relies on robust pharmacy access. Arcutis Biotherapeutics, Inc. has secured broad coverage for the ZORYVE portfolio across major payers. This access is critical for ensuring patients can actually fill the prescriptions written by the sales forces.
Here's a snapshot of the payer access supporting the distribution channels as of early to mid-2025:
| Access Point/Payer Group | Status/Metric (as of Q1/Q3 2025) | Product Scope |
| Three Largest National PBMs | Covering entire ZORYVE portfolio | ZORYVE Portfolio |
| Medicaid Coverage | More than 1 in 2 recipients have coverage | ZORYVE Portfolio |
| ZORYVE Cream 0.15% (Atopic Derm) | Coverage by the three largest national PBMs | Cream 0.15% |
| Gross-to-Net (GTN) Rate | Maintained in the 50s (as of Q1 2025) | ZORYVE Portfolio |
The company anticipates continued improvement in GTN rates for ZORYVE cream 0.15% in 2025, aiming to converge on the GTN of their other products.
Digital marketing and patient education platforms
While specific digital marketing spend isn't broken out, the success of the commercialization efforts, which include digital components, is driving significant revenue growth. The overall strategy involves educating both providers and patients on the value proposition of ZORYVE as a steroid-free alternative.
The results flowing through all channels, including digital engagement, show strong commercial traction:
- Q3 2025 Net Product Revenue was $99.2 million.
- This represented a 122% increase compared to Q3 2024.
- The company provided initial 2026 full-year net product sales guidance between $455 million and $470 million.
The shift away from topical steroids is a key trend supporting these channels, with the non-steroidal topical volume increasing by over 60% over the last six quarters, led by ZORYVE.
Arcutis Biotherapeutics, Inc. (ARQT) - Canvas Business Model: Customer Segments
You're hiring before product-market fit...
Arcutis Biotherapeutics, Inc. targets a substantial base of patients suffering from chronic inflammatory skin diseases, primarily through its ZORYVE portfolio.
The overall diagnosed patient population across the currently approved indications of psoriasis, atopic dermatitis (AD), and seborrheic dermatitis in the U.S. totals approximately 30 million patients. Of these, about 19 million people are already receiving topical treatment, mainly topical corticosteroids (TCS).
The focus is on converting this large base of TCS prescriptions to non-steroidal alternatives.
U.S. Dermatologists and other dermatology clinicians
This segment represents the core prescribers for the initial ZORYVE indications. The company has a very well-sized dermatology sales force dedicated to this group.
- Over 18,000 unique prescribers have filled prescriptions for ZORYVE cream 0.3% in plaque psoriasis since launch.
- The top 30,000 prescribers in these segments account for nearly a third of all prescriptions.
The company has no plans for further expansion of the Arcutis dermatology sales force at this time, relying on existing coverage and frequency.
Patients (Adults and Adolescents) with plaque psoriasis, AD, or seborrheic dermatitis
This segment covers the broadest range of currently approved indications for the ZORYVE franchise.
| Indication | Approved Patient Population (Age) | US Prevalence (Approximate) |
| Plaque Psoriasis (Cream/Foam) | Adults and adolescents 12 years of age and older (Foam) | Approximately 9 million individuals |
| Atopic Dermatitis (AD) (Cream 0.15%) | Adults and pediatric patients 6 years of age and older | Approximately 26 million adults and children |
| Seborrheic Dermatitis (Foam 0.3%) | Adult and pediatric patients 9 years of age and older | Part of the 30 million diagnosed population |
More than half of the psoriasis population experiences scalp involvement, a segment addressed by ZORYVE foam 0.3%.
Children (ages 2+) with atopic dermatitis (AD)
Arcutis Biotherapeutics is actively pursuing label expansion to capture younger pediatric patients with AD.
- ZORYVE cream 0.05% for AD in children ages 2 to 5 years old had a Prescription Drug User Fee Act (PDUFA) target action date of October 13, 2025.
- This specific pediatric AD population is estimated at about 1.8 million patients.
- The company initiated the INTEGUMENT-INFANT study for ZORYVE cream 0.05% in infants ages 3 months to 24 months.
Primary Care Practitioners and Pediatricians (newly targeted prescribers)
Accessing primary care and pediatrics is viewed as an opportunity outside of the core dermatology specialty.
The company is utilizing a co-promotion partnership with Kowa to access these channels economically.
Finance: draft 13-week cash view by Friday.
Arcutis Biotherapeutics, Inc. (ARQT) - Canvas Business Model: Cost Structure
You're looking at the core spending areas for Arcutis Biotherapeutics, Inc. as they scale their commercial operations. For the third quarter of 2025, the major operating costs were clear. Selling, General, and Administrative (SG&A) expenses hit $62.4 million. This is a significant chunk of the spend, reflecting the push to get ZORYVE to more patients. Also in Q3 2025, Research and Development (R&D) expenses were $19.6 million. That R&D spend keeps the pipeline moving, like advancing ZORYVE life cycle management and the ARQ-234 program.
To give you a snapshot of how revenues map against these costs for that quarter, here's the quick math:
| Financial Metric (Q3 2025) | Amount (in Millions USD) |
| Total Revenues (Net Product) | $99.2 |
| Cost of Sales (COGS) | $8.7 |
| SG&A Expenses | $62.4 |
| R&D Expenses | $19.6 |
Cost of Goods Sold (COGS) for the third quarter of 2025 was $8.7 million, up from $5.5 million in Q3 2024, mainly because ZORYVE sales volume increased. This relatively low COGS, set against the $99.2 million in net product revenue for the quarter, points to the high gross margin Arcutis is achieving. Honestly, the trailing twelve months showed an impressive gross profit margin of about 89.1%, which is definitely a key cost advantage.
The SG&A figure is heavily influenced by the commercial build-out. You see the direct impact of sales and marketing costs for the commercial team expansion in that $62.4 million total. For context, the SG&A in Q2 2025 was about 10% lower, primarily because of the timing of promotional and marketing expenditures between quarters. The investment here is directly tied to driving adoption across all approved indications for ZORYVE.
Then you have the external, non-operating costs like licensing. Arcutis Biotherapeutics made a specific, one-time cash outlay related to past success. Specifically, the company made a $10.0 million cash milestone payment to AstraZeneca. This payment was incurred in the first quarter of 2025 because a sales milestone of $250 million was reached.
- SG&A expenses in Q3 2025 were $62.4 million.
- R&D expenses for Q3 2025 were $19.6 million.
- COGS for Q3 2025 was $8.7 million.
- A $10.0 million milestone payment was made to AstraZeneca in Q1 2025.
- Q3 2025 SG&A was up 6% year-over-year from $58.8 million.
Finance: review the Q4 2025 SG&A forecast against the Q3 spend by next Tuesday.
Arcutis Biotherapeutics, Inc. (ARQT) - Canvas Business Model: Revenue Streams
You're looking at the core ways Arcutis Biotherapeutics, Inc. brings in money right now, which is heavily concentrated on one product family, ZORYVE. This focus is key to understanding their short-term financial picture as of late 2025.
The primary revenue driver is Net Product Revenue from ZORYVE sales, which hit $99.2 million in the third quarter of 2025. This represents substantial growth, showing a 122% increase compared to the third quarter of 2024, and a 22% sequential increase from the second quarter of 2025. That's defintely strong commercial momentum.
The breakdown of that $99.2 million in Q3 2025 net product revenue shows how the different ZORYVE formulations are performing:
| ZORYVE Product Stream | Q3 2025 Revenue (Millions USD) |
| Revenue from ZORYVE topical foam 0.3% | $49.8 million |
| Revenue from ZORYVE cream 0.3% | $30.5 million |
| Revenue from ZORYVE cream 0.15% | $18.9 million |
This table clearly shows the foam formulation is currently the largest single contributor to the product revenue stream.
Beyond current sales, Arcutis Biotherapeutics, Inc. has revenue potential built into its international agreements, specifically through milestone payments. These are non-guaranteed payments triggered by specific events, which is a common structure in pharma licensing deals.
Potential future milestone payments from international partnerships include:
- Potential additional payments totaling $40 million contingent upon meeting specified regulatory and sales milestones from the Sato License agreement for Japan.
- The Sato agreement also provided an upfront payment of $25 million.
- Eligibility for tiered, low double-digit percentage royalties on net sales in Japan post-launch.
Finally, a significant near-term addition to the revenue base is the expansion into a younger pediatric market. Sales of ZORYVE cream 0.05% for pediatric AD began in late 2025, following FDA approval in October 2025 for children ages 2 to 5 years. This launch, occurring in Q4 2025, sets up the next wave of revenue capture, expanding the addressable market for the ZORYVE franchise.
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