ARQT

MKT CAP $4BP/E 151.8DIV YIELD —FCF YIELD 0.98%REV TTM $464M +76.1%NET INCOME $28.5MNET DEBT $74.8M52W 19.50 – 32.82SEC XBRL · TTM TO Invalid Date

How ARQT rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025

Text kept

61%

of sentences unchanged

Added

235

new sentences

Dropped

229

sentences removed

Length

−555

words, now 38,077

New in FY2025

Risks Related to Our Limited Operating History, Financial Condition, and Capital Requirements We are a commercial-stage biopharmaceutical company with four products approved for commercial sale.
We have incurred significant losses since our inception and could incur losses in the future, which, together with our limited history as a commercial-stage company, makes it difficult to assess our future viability.
We have a limited history as a commercial-stage company upon which you can evaluate our business and prospects, and have not yet demonstrated an ability to successfully overcome many of the risks and uncertainties frequently encountered by companies in new and rapidly evolving fields.
Our net loss for the year ended December 31, 2025 was approximately $16.1 million.
As of December 31, 2025, we had an accumulated deficit of $1,138.1 million.
We commercially launched our first product, ZORYVE cream 0.3%, in August 2022; our second product, ZORYVE foam, in late January 2024; our third product, ZORYVE cream 0.15%, in July 2024; and our fourth product, ZORYVE cream 0.05%, in October 2025.
We have generally and may incur losses until our revenue from product sales of ZORYVE and any other approved products exceeds expenses.
We cannot anticipate when we will achieve sustained profitability.
Losses have had and may have an adverse effect on our stockholders’ equity and working capital.
In addition, we may Index to Financial Statements encounter unforeseen expenses, difficulties, complications, delays, and other known or unknown factors in achieving our business objectives.
Our operating expenses and capital requirements are difficult to predict, depend on many factors and are affected by, and are subject to assumptions regarding, among others: • the timing, receipt, and amount of sales of any current and future products, including the success of our commercialization efforts involving ZORYVE; • market acceptance of our current and future products, including ZORYVE, and the impact of competing products; • the ability of patients or health care providers to obtain coverage of or sufficient reimbursement for any current or future products; • our ability to successfully execute on our business plan and our internal projections and estimates of costs and execution timing; • the scope, progress, results, and costs of developing product candidates and conducting nonclinical studies and clinical trials, including in connection with our current product candidates; • suspensions or delays in enrollment of our ongoing and future clinical trials, issues with data collection, or changes to the number of subjects we decide to enroll in our clinical trials, including as a result of competing trials or otherwise; • the number and scope of clinical programs we decide to pursue, and the number and characteristics of any product candidates we develop or acquire; • the timing of, and the costs involved in, obtaining regulatory reviews and approvals for our product candidates; • the cost of manufacturing any current and future products and product candidates, including any products we successfully commercialize and the costs associated with building out our supply chain; • the cost of commercialization activities for any current and future products that are approved for sale, including marketing, sales, and distribution costs, and any discounts or rebates to obtain access; • our ability to establish and maintain strategic collaborations, licensing, or other arrangements and the financial terms of any such agreements that we may enter into; • the impact of any acquisitions or similar transactions or partnerships; • the costs related to milestone and royalty payments due to AstraZeneca, Hengrui, the former owners of Ducentis, which we acquired in September 2022, or any future collaboration or licensing partners upon the achievement of negotiated milestones; • any product liability or other lawsuits related to our products; Index to Financial Statements • the expenses needed to attract and retain skilled personnel; and • the costs involved in preparing, filing, prosecuting, maintaining, defending, and enforcing our intellectual property portfolio.
As of December 31, 2025, we had capital resources consisting of cash, cash equivalents, and marketable securities of $221.0 million.
In addition, as of December 31, 2025, we had $100.0 million outstanding under our loan and security agreement, or the Loan Agreement, with SLR Investment Corp.(SLR), and the lenders party thereto.
Our operating results may fluctuate due to a variety of factors, many of which are outside of our control and may be difficult to predict, including the following: • our ability to commercialize approved products and our ability to receive approval and commercialize our product candidates both within and outside of the United States; • market acceptance of any current and future products and our ability to forecast demand for such products; • the level of demand for any current and future products, which may vary significantly; • the ability of patients or health care providers to obtain coverage of or sufficient reimbursement for any current or future products; • the willingness of patients to pay out-of-pocket for any current or future products in the absence of health insurance coverage or sufficient reimbursement; • the ability to obtain and maintain good coverage and quality reimbursement of our products and future products; • delays in the commencement, enrollment, and the timing of clinical testing for our product candidates, in light of competing trials or otherwise; • the timing and success or failure of clinical trials for our product candidates or competing product candidates, or any other change in the competitive landscape of our industry, including consolidation among our competitors or partners; • any delays in regulatory review and approval of product candidates in clinical development, or failure to obtain such approvals; • the timing and cost of, and level of investment in, research and development activities relating to our product candidates, which may change from time to time and are subject to inflation and other drivers; • the cost of manufacturing any current and future products and product candidates, which may vary depending on U.S.
FDA guidelines and requirements, and the quantity of production; • our ability to obtain funding to develop our products and product candidates and operate our business; Index to Financial Statements • expenditures that we will or may incur to acquire or develop additional product candidates and technologies, which may include obligations to make significant upfront and milestone payments; • potential side effects of any current and future products and product candidates that could delay or prevent commercialization or cause an approved product to be taken off the market; • our dependency on Contract Research Organizations (CROs) to help manage our clinical trials, and third-party manufacturers for adequate supply or manufacturing capabilities; • our ability to establish and maintain collaborations, licensing, or other arrangements; • our ability to maintain and enforce our intellectual property position; • costs related to and outcomes of potential litigation, potential government investigations, or other disputes; • our ability to adequately support future growth; • our ability to attract and retain key personnel to manage our business effectively; • potential liabilities associated with hazardous materials; • our ability to maintain adequate insurance policies; and • future accounting pronouncements or changes in our accounting policies.
The terms of our loan and security agreement require us to meet certain operating and financial covenants, and place restrictions on our operating and financial flexibility.
As of December 31, 2025, we had $100.0 million outstanding under our Loan Agreement.
The Index to Financial Statements tranche C-1 term loan availability will expire on March 31, 2026 and the tranche C-2 term loan availability will expire on June 30, 2026.
We cannot assure that our business will be able to generate sufficient cash flow from operations or that future borrowings or other financings will be available to us in an amount sufficient to enable us to service our indebtedness and fund our other liquidity needs.
For example, we have established an internal commercial infrastructure as well as a dermatologist-focused sales and distribution infrastructure to market ZORYVE and our product candidates in the United States and Canada, and have completed hiring in areas to support commercialization, including in sales management, sales Index to Financial Statements representatives, marketing, access and reimbursement, sales support, and distribution.
We currently have four products approved for commercial sale: ZORYVE cream 0.3%, a potent PDE4 inhibitor topical cream approved by the FDA in July 2022 for the treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older (subsequently expanded to patients 6 years of age and older); ZORYVE foam, a potent PDE4 inhibitor topical foam approved by the FDA in December 2023 for the treatment of seborrheic dermatitis in individuals aged 9 years and older; ZORYVE cream 0.15%, a potent PDE4 inhibitor topical cream for the treatment of atopic dermatitis in adults and pediatric patients 6 years of age and older approved by the FDA in July 2024; and ZORYVE foam, a potent PDE4 inhibitor topical foam approved by the FDA in May 2025 for the treatment of scalp and body psoriasis in adult and pediatric patients 6 years of age and older.
We also received FDA approval for, and commercially launched, ZORYVE cream 0.05% for the topical treatment of mild-to-moderate atopic dermatitis in children 2 to 5 years of age in October 2025.
Our product candidate portfolio includes ARQ-234, a CD200R fusion protein for the treatment of moderate-to-severe atopic dermatitis.
We currently do not have drug discovery efforts, and we have no intention of developing a drug discovery capability.
We expect to conduct most of our clinical trials in the United States and Canada, with limited reliance on Australia, the Caribbean, and the European Union for clinical trial subjects.
The commercial success of ZORYVE and the clinical and commercial success of other product candidates will depend on a number of factors, including the following: • timely completion of our nonclinical studies and clinical trials, which may be significantly slower or cost more than we currently anticipate, including as a result of competitive trials, and will depend substantially upon the performance of third-party contractors; • whether we are required by the FDA or similar foreign regulatory authorities to conduct additional clinical trials or other studies beyond those planned to support the approval and commercialization of our product candidates or any future product candidates; • acceptance of our proposed indications and primary and secondary endpoint assessments relating to the proposed indications of our product candidates by the FDA and similar foreign regulatory authorities; • the prevalence, duration, and severity of potential side effects or other safety issues experienced with ZORYVE or our product candidates; • the timely receipt of necessary marketing approvals from the FDA and similar foreign regulatory authorities; • achieving, maintaining, and, where applicable, ensuring that our third-party contractors achieve and maintain, compliance with our contractual obligations and with all regulatory requirements applicable to ZORYVE or any of our product candidates; • the willingness of physicians and patients to utilize or adopt ZORYVE and our product candidates, if approved; Index to Financial Statements • the ability of third parties upon which we rely to manufacture clinical trial and commercial supplies of ZORYVE or any of our product candidates to remain in good standing with relevant regulatory authorities and to develop, validate, and maintain commercially viable manufacturing processes that are compliant with cGMP; • our ability to successfully implement and execute on a marketing strategy for ZORYVE and to commercialize any of our product candidates in the United States and internationally, if approved, whether alone or in collaboration with others; • the availability of coverage and adequate reimbursement from private third-party payers and governmental health care programs, such as Medicare and Medicaid; • acceptance by physicians, payers, and patients of the benefits, safety, and efficacy of ZORYVE or any product candidates, if approved, including relative to alternative and competing treatments; • patient demand for any approved products; • our ability to establish and enforce intellectual property rights in and to any current and future products and product candidates; • our ability to avoid third-party patent interference, intellectual property challenges, or intellectual property infringement claims; and • the ability to raise any additional required capital on acceptable terms, or at all.
Furthermore, because ZORYVE and each of our product candidates targets one or more indications in the medical dermatology field, if ZORYVE or any of our product candidates encounter safety or efficacy problems, developmental delays, regulatory issues, supply issues, or other problems, our development plans for the affected product or product candidate and some or all of our other product candidates could be significantly harmed, which would harm our business.
The degree of market acceptance will depend on a number of factors, including but not limited to: • the safety, efficacy, risk-benefit profile, and potential advantages compared to alternative or existing treatments, such as steroids topical treatments, oral treatments, and biologic injections for the treatment of psoriasis, which physicians may perceive to be adequately effective for some or all patients; • the prevalence and severity of any side effects and the difficulty of, or costs associated with, resolving such side effects; • the content of the approved product label, including any limitations or warnings contained in the labeling approved by FDA or other applicable foreign regulatory authorities; • any restrictions on the use of our products; • the effectiveness of our sales and marketing efforts; • the strength of our marketing and distribution support; Index to Financial Statements • the cost of treatment in relation to alternative treatments, including any similar generic treatments and over-the-counter (OTC) treatments; • our ability to offer our products for sale at competitive prices; • the convenience and ease of administration compared to alternative treatments; • the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies over existing therapies; • the availability of coverage and adequate reimbursement from private third-party payers and governmental health care programs, such as Medicare and Medicaid; • the willingness of patients to pay out-of-pocket in the absence of health insurance coverage or sufficient reimbursement; and • utilization controls imposed by third-party payers, such as prior authorizations and step edits.
There can be no assurance that ZORYVE or our current or future product candidates, if approved, will achieve market acceptance among physicians, patients, third-party payers, or others in the medical community necessary for commercial success.
The availability of coverage and adequate reimbursement from governmental health care programs, such as Medicare and Medicaid, and private third-party payers is critical to new product acceptance.
Third-party payers, whether foreign or domestic, or governmental or commercial, are developing increasingly sophisticated methods of controlling health care costs.
Therefore, coverage and reimbursement for drug products can differ significantly from payer to payer.
Index to Financial Statements Clinical drug development involves a lengthy and expensive process, with an uncertain outcome.
Before obtaining marketing approval from regulatory authorities for the sale of any product candidate, we must complete nonclinical development and then conduct extensive clinical trials to demonstrate the safety and efficacy of our product candidates in humans, or with respect to our product candidates regulated as biologics, the safety, purity, and potency of such product candidates.
In addition, we could also encounter delays if a clinical trial is suspended or terminated by us, by the IRBs of the institutions in which such trials are being conducted, by the data safety monitoring board for such trial, or by the FDA or other regulatory authorities.
Such authorities may impose such a suspension or termination due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or side effects, failure to demonstrate a benefit Index to Financial Statements from using a drug, changes in governmental regulations or administrative actions, or lack of adequate funding to continue the clinical trial.
To gain approval to expand the label of our products or market our product candidates, we must provide the FDA and foreign regulatory authorities with nonclinical and clinical data that adequately demonstrate the safety and efficacy, or as applicable, the safety, purity, and potency of the product for the intended indication applied for in the applicable regulatory filing.
The FDA or any foreign regulatory authorities can delay, limit, or deny approval of expanded labels for our products or our product candidates for many reasons, including: • our inability to demonstrate to the satisfaction of the FDA or the applicable foreign regulatory authority that any of our product candidates is safe and effective or, with respect to product candidates regulated as biologics, safe, pure, and potent for the requested indication; • the FDA or other relevant foreign regulatory authorities may disagree with the number, design, size, conduct, or implementation of our clinical trials; • the FDA or other relevant foreign regulatory authorities may not find the data from nonclinical studies or clinical trials sufficient to demonstrate that the clinical and other benefits of these products candidates outweigh their safety risks or that there is an acceptable risk-benefit profile; • the results of our clinical trials may not meet the level of statistical significance or clinical meaningfulness required by the FDA or other relevant foreign regulatory authorities for marketing approval; • the FDA’s or the applicable foreign regulatory authority’s requirement for additional nonclinical studies or clinical trials which would increase our costs and prolong our development timelines; • the FDA or other relevant foreign regulatory authorities may disagree with our interpretation of data or significance of results from the nonclinical studies and clinical trials of any product or product candidate, or may require that we conduct additional studies; • the FDA or other relevant foreign regulatory authorities may not accept data generated from our clinical trial sites; Index to Financial Statements • the CROs that we retain to conduct clinical trials may take actions outside of our control, or otherwise commit errors or breaches of protocols, that adversely impact our clinical trials and ability to obtain market approvals; • if an NDA, BLA, or other foreign application is reviewed by an advisory committee, the FDA or other relevant foreign regulatory authority, as the case may be, may have difficulties scheduling an advisory committee meeting in a timely manner or the advisory committee may recommend against approval of our application or may recommend that the FDA or other relevant foreign regulatory authority, as the case may be, require, as a condition of approval, additional nonclinical studies or clinical trials, limitations on approved labeling, or distribution and use restrictions; • the FDA or other relevant foreign regulatory authorities may require development of a Risk Evaluation and Mitigation Strategy (REMS), or its equivalent, as a condition of approval; • the FDA or other relevant foreign regulatory authorities may require additional post-marketing studies and/or a patient registry, which would be costly; • the FDA or other relevant foreign regulatory authorities may find the chemistry, manufacturing, and controls data insufficient to support the quality of our product candidates; • the FDA or other relevant foreign regulatory authorities may identify deficiencies in the manufacturing processes or facilities of our third-party manufacturers; • the FDA or other relevant foreign regulatory authorities may change their approval policies or adopt new regulations; • the FDA’s or the applicable foreign regulatory authority’s non-approval of the formulation, dosing, labeling, or specifications; • the FDA’s or the applicable foreign regulatory authority’s failure to approve the manufacturing processes of third-party manufacturers upon which we rely or the failure of the facilities of our third-party manufacturers to maintain a compliance status acceptable to the FDA or the applicable foreign regulatory authority; or • the potential for approval policies or regulations of the FDA or the applicable foreign regulatory authorities to significantly change in a manner rendering our clinical data insufficient for approval.
Topline or preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
Topline and preliminary data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we Index to Financial Statements previously published.

and 195 more.

Gone since FY2024

Risks Related to Our Limited Operating History, Financial Condition, and Capital Requirements We are a commercial-stage biopharmaceutical company with three products approved for commercial sale.
We have incurred significant losses since our inception and could continue to incur losses, which, together with our limited history as a commercial-stage company, makes it difficult to assess our future viability.
We are a commercial - stage biopharmaceutical company with three products approved for commercial sale.
We have a limited history as a commercial-stage company upon which you can evaluate our business and Index to Financial Statement s prospects, and have not yet demonstrated an ability to successfully overcome many of the risks and uncertainties frequently encountered by companies in new and rapidly evolving fields.
Our net loss for the year ended December 31, 2024 was approximately $140.0 million.
As of December 31, 2024, we had an accumulated deficit of $1,121.9 million.
We commercially launched our first product, ZORYVE cream 0.3%, in August 2022, our second product, ZORYVE foam, in late January 2024, and our third product, ZORYVE cream 0.15%, in July 2024.
We expect to continue to incur losses until our revenue from product sales of ZORYVE and any other approved products exceeds expenses, which may never occur.
We may never achieve profitability and, even if we do, we may not be able to sustain or increase our profitability.
Our prior losses, combined with anticipated future losses, have had and will continue to have an adverse effect on our stockholders’ equity and working capital.
In addition, we may encounter unforeseen expenses, difficulties, complications, delays, and other known or unknown factors in achieving our business objectives.
Our operating expenses and capital requirements are difficult to predict, depend on many factors and are affected by, and are subject to assumptions regarding, among others: • the timing, receipt, and amount of sales of any current and future products, including the success of our commercialization efforts involving ZORYVE; • market acceptance of our current and future products, including ZORYVE, and the impact of competing products; • the ability of patients or healthcare providers to obtain coverage of or sufficient reimbursement for any current or future products; • our ability to successfully execute on our business plan and our internal projections and estimates of costs and execution timing; • the scope, progress, results, and costs of developing product candidates and conducting nonclinical studies and clinical trials, including in connection with our current product candidates; • suspensions or delays in enrollment of our ongoing and future clinical trials, issues with data collection, or changes to the number of subjects we decide to enroll in our clinical trials, including as a result of competing trials or otherwise; • the number and scope of clinical programs we decide to pursue, and the number and characteristics of any product candidates we develop or acquire; • the timing of, and the costs involved in, obtaining regulatory reviews and approvals for our product candidates; Index to Financial Statement s • the cost of manufacturing any current and future products and product candidates, including any products we successfully commercialize and the costs associated with building out our supply chain; • the cost of commercialization activities for any current and future products that are approved for sale, including marketing, sales, and distribution costs, and any discounts or rebates to obtain access; • our ability to establish and maintain strategic collaborations, licensing, or other arrangements and the financial terms of any such agreements that we may enter into; • the impact of any acquisitions or similar transactions or partnerships; • the costs related to milestone and royalty payments due to AstraZeneca, Hengrui, the former owners of Ducentis, which we acquired in September 2022, or any future collaboration or licensing partners upon the achievement of negotiated milestones; • any product liability or other lawsuits related to our products; • the expenses needed to attract and retain skilled personnel; and • the costs involved in preparing, filing, prosecuting, maintaining, defending, and enforcing our intellectual property portfolio.
As of December 31, 2024, we had capital resources consisting of cash, cash equivalents, and marketable securities of $228.0 million.
In addition, as of December 31, 2024, we had $100.0 million outstanding under our loan and security agreement, or the Loan Agreement, with SLR Investment Corp., or SLR, and the lenders party thereto.
Our operating results may fluctuate due to a variety of factors, many of which are outside of our control and may be difficult to predict, including the following: • our ability to commercialize approved products and our ability to receive approval and commercialize our product candidates both within and outside of the United States; • market acceptance of any current and future products and our ability to forecast demand for such products; • the level of demand for any current and future products, which may vary significantly; • the ability of patients or healthcare providers to obtain coverage of or sufficient reimbursement for any current or future products; • the willingness of patients to pay out-of-pocket for any current or future products in the absence of health insurance coverage or sufficient reimbursement; • delays in the commencement, enrollment, and the timing of clinical testing for our product candidates, in light of competing trials or otherwise; Index to Financial Statement s • the timing and success or failure of clinical trials for our product candidates or competing product candidates, or any other change in the competitive landscape of our industry, including consolidation among our competitors or partners; • any delays in regulatory review and approval of product candidates in clinical development, or failure to obtain such approvals; • the timing and cost of, and level of investment in, research and development activities relating to our product candidates, which may change from time to time and are subject inflation and other drivers; • the cost of manufacturing any current and future products and product candidates, which may vary depending on U.S.
FDA guidelines and requirements, and the quantity of production; • our ability to obtain funding to develop our products and product candidates and operate our business; • expenditures that we will or may incur to acquire or develop additional product candidates and technologies, which may include obligations to make significant upfront and milestone payments; • potential side effects of any current and future products and product candidates that could delay or prevent commercialization or cause an approved product to be taken off the market; • our dependency on Contract Research Organizations (CROs) to help manage our clinical trials, and third-party manufacturers for adequate supply or manufacturing capabilities; • our ability to establish and maintain collaborations, licensing, or other arrangements; • our ability to maintain and enforce our intellectual property position; • costs related to and outcomes of potential litigation, potential government investigations, or other disputes; • our ability to adequately support future growth; • our ability to attract and retain key personnel to manage our business effectively; • potential liabilities associated with hazardous materials; • our ability to maintain adequate insurance policies; and • future accounting pronouncements or changes in our accounting policies.
Index to Financial Statement s The terms of our loan and security agreement require us to meet certain operating and financial covenants, and place restrictions on our operating and financial flexibility.
As of December 31, 2024, we had $100.0 million outstanding under our Loan Agreement.
The tranche C-1 term loan availability will expire on March 31, 2026 and the tranche C-2 term loan availability will expire on June 30, 2026.
We cannot assure you that our business will be able to generate sufficient cash flow from operations or that future borrowings or other financings will be available to us in an amount sufficient to enable us to service our indebtedness and fund our other liquidity needs.
We are a large accelerated filer and no longer qualify as a “smaller reporting company,” which requires additional compliance initiatives and heightened disclosure and reporting requirements.
We are subject to Section 404 of the Sarbanes-Oxley Act, which generally requires a company's management to report upon the effectiveness of internal control over financial reporting and an independent registered public accounting firm to attest to the effectiveness of internal control over financial reporting in annual reports on Form 10-K.
However, during any period in which we qualified as a smaller reporting company, we were not required to include an attestation report on internal control over financial reporting issued by our independent registered public accounting firm.
As of June 30, 2024, the market value of our ordinary shares held by non-affiliates exceeded $700.0 million.
As a result, we became a large accelerated filer, effective December 31, 2024.
As a result Index to Financial Statement s of this transition, we are required to include an attestation report on internal control over financial reporting issued by our independent registered public accounting firm with this Annual Report on Form 10-K for the fiscal year ending December 31, 2024.
To prepare for compliance with Section 404, we engaged in a process to document and evaluate our internal control over financial reporting, which was both costly and challenging.
In this regard, we dedicated internal resources, engaged outside consultants and adopted a detailed work plan to assess and document the adequacy of internal control over financial reporting.
We have continued steps to improve control processes as appropriate, validate through testing that controls are functioning as documented and implement a continuous reporting and improvement process for internal control over financial reporting.
As a result of this transition, we are subject to certain disclosure and compliance requirements that apply to other public companies but did not previously apply to us during the period in which we qualified as a smaller reporting company, and we are not able to take advantage of certain scaled disclosures available to smaller reporting companies.
Any failure to comply with the increased disclosure and reporting requirements could have an adverse effect on our business, financial condition and results of operations.
For example, we have established an internal commercial infrastructure as well as a dermatologist-focused sales and distribution infrastructure to market ZORYVE and our product candidates in North America, and have completed hiring in areas to support commercialization, including in sales management, sales representatives, marketing, access and reimbursement, sales support, and distribution.
We currently have three products approved for commercial sale: ZORYVE cream 0.3%, a potent PDE4 inhibitor topical cream approved by the FDA on July 29, 2022, for the treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older (subsequently expanded to patients 6 years of age and older); ZORYVE foam, a potent PDE4 inhibitor topical foam approved by the FDA on December 15, 2023, for the treatment of seborrheic dermatitis in individuals aged 9 years and older; and ZORYVE cream 0.15%, a potent PDE4 inhibitor topical cream for the treatment of atopic dermatitis in adults and pediatric patients 6 years of age and older, which was approved on July 9, 2024.
Our product candidate portfolio includes ZORYVE foam for the treatment of scalp and body psoriasis, ZORYVE cream 0.05% for the treatment of atopic dermatitis in patients ages 2 to 5, Index to Financial Statement s ARQ-255, a potent and highly selective topical JAK1 inhibitor under development for the treatment of alopecia areata, ARQ-252, an alternative formulation of our topical JAK1 inhibitor under development for the treatment of chronic hand eczema and vitiligo, and ARQ-234, a CD200R fusion protein for the treatment of moderate-to-severe atopic dermatitis.
We currently do not have drug discovery efforts, and we have no intention to develop a drug discovery capability.
We expect to conduct most of our clinical trials in the United States and Canada, with limited reliance on Australia, the Caribbean, and the European Union for clinical trials subjects.
The commercial success of ZORYVE and the clinical and commercial success of other product candidates will depend on a number of factors, including the following: • timely completion of our nonclinical studies and clinical trials, which may be significantly slower or cost more than we currently anticipate, including as a result of competitive trials, and will depend substantially upon the performance of third-party contractors; • whether we are required by the FDA or similar foreign regulatory authorities to conduct additional clinical trials or other studies beyond those planned to support the approval and commercialization of our product candidates or any future product candidates; • acceptance of our proposed indications and primary and secondary endpoint assessments relating to the proposed indications of our product candidates by the FDA and similar foreign regulatory authorities; • the prevalence, duration, and severity of potential side effects or other safety issues experienced with ZORYVE or our product candidates; • the timely receipt of necessary marketing approvals from the FDA and similar foreign regulatory authorities; • achieving, maintaining, and, where applicable, ensuring that our third-party contractors achieve and maintain, compliance with our contractual obligations and with all regulatory requirements applicable to ZORYVE or any of our product candidates; • the willingness of physicians and patients to utilize or adopt ZORYVE and our product candidates, if approved; • the ability of third parties upon which we rely to manufacture clinical trial and commercial supplies of ZORYVE or any of our product candidates to remain in good standing with relevant regulatory authorities and to develop, validate, and maintain commercially viable manufacturing processes that are compliant with cGMP; • our ability to successfully implement and execute on a marketing strategy for ZORYVE and to commercialize any of our product candidates in the United States and internationally, if approved, whether alone or in collaboration with others; • the availability of coverage and adequate reimbursement from private third-party payers and governmental healthcare programs, such as Medicare and Medicaid; • acceptance by physicians, payers, and patients of the benefits, safety, and efficacy of ZORYVE or any product candidates, if approved, including relative to alternative and competing treatments; • patient demand for any approved products; • our ability to establish and enforce intellectual property rights in and to any current and future products and product candidates; • our ability to avoid third-party patent interference, intellectual property challenges, or intellectual property infringement claims; and • the ability to raise any additional required capital on acceptable terms, or at all.
Index to Financial Statement s Furthermore, because ZORYVE and each of our product candidates targets one or more indications in the medical dermatology field, if ZORYVE or any of our product candidates encounter safety or efficacy problems, developmental delays, regulatory issues, supply issues, or other problems, our development plans for the affected product or product candidate and some or all of our other product candidates could be significantly harmed, which would harm our business.
The degree of market acceptance will depend on a number of factors, including but not limited to: Index to Financial Statement s • the safety, efficacy, risk-benefit profile, and potential advantages compared to alternative or existing treatments, such as steroids topical treatments, oral treatments, and biologic injections for the treatment of psoriasis, which physicians may perceive to be adequately effective for some or all patients; • the prevalence and severity of any side effects and the difficulty of, or costs associated with, resolving such side effects; • the content of the approved product label, including any limitations or warnings contained in the labeling approved by FDA or other applicable foreign regulatory authorities; • any restrictions on the use of our products; • the effectiveness of our sales and marketing efforts; • the strength of our marketing and distribution support; • the cost of treatment in relation to alternative treatments, including any similar generic treatments and over-the-counter (OTC) treatments; • our ability to offer our products for sale at competitive prices; • the convenience and ease of administration compared to alternative treatments; • the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies over existing therapies; • the availability of coverage and adequate reimbursement from private third-party payers and governmental healthcare programs, such as Medicare and Medicaid; • the willingness of patients to pay out-of-pocket in the absence of health insurance coverage or sufficient reimbursement; and • utilization controls imposed by third-party payers, such as prior authorizations and step edits.
We cannot assure you that ZORYVE or our current or future product candidates, if approved, will achieve market acceptance among physicians, patients, third-party payers, or others in the medical community necessary for commercial success.

and 189 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

Watch ARQT. Know when insiders buy.

One email the day a filing lands. Free.