ARQT on Nasdaq

Arcutis Biotherapeutics, Inc.

In its 2026 annual report the company says: “We are a commercial-stage biopharmaceutical company focused on developing and commercializing treatments for dermatological diseases with high unmet medical needs. Our current portfolio is comprised of highly differentiated topical and systemic treatments with significant potential to treat immune-mediated dermatological diseases and conditions.”4 It is headquartered in Westlake Village, California.1 Its shares trade on Nasdaq under the symbol ARQT.1

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Last updated Oct 21, 2026.

Overview

Compare with Sinovac Biotech, Atea Pharmaceuticals, Inc. or Esperion Therapeutics, or pick any stock.

  • TickerARQT on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersWestlake Village, California1
  • Incorporated inDE2
  • Business address3027 Townsgate Road, Suite 300, Westlake Village, Ca 913612
  • Filer categoryLarge accelerated filer2

We are a commercial-stage biopharmaceutical company focused on developing and commercializing treatments for dermatological diseases with high unmet medical needs. Our current portfolio is comprised of highly differentiated topical and systemic treatments with significant potential to treat immune-mediated dermatological diseases and conditions. We believe we have built a leading platform for dermatologic product development and commercialization. Our strategy is to focus on validated biological targets, and to use our drug development platform and deep dermatology expertise to develop and commercialize differentiated products that have the potential to address the major shortcomings of existing therapies in our targeted indications. We believe this strategy uniquely positions us to rapidly advance our goal of bridging the treatment innovation gap in dermatology, while maximizing our pro…4 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

-3.3%Operating margin5
-4.3%Net margin5
91.3%Revenue growth, 20255
-8.5%Return on equity5
0.57×Debt to equity5
-$6.3MFree cash flow5

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Products and services

ZORYVE Foam brought in 49% of the revenue Arcutis Biotherapeutics, Inc. broke down this way in fiscal 2025.

  1. ZORYVE Foam$181.9M549%up 154% from 2024
  2. ZORYVE Cream 0.3%$121.0M533%up 42% from 2024
  3. ZORYVE Cream 0.15%$68.3M518%up 588% from 2024
  4. ZORYVE cream 0.05%$911.0K50%
Products and services by year
Products and services202320242025
ZORYVE Foam$0$71.5M$181.9M
ZORYVE Cream 0.3%$29.2M$85.1M$121.0M
ZORYVE Cream 0.15%$0$9.9M$68.3M
ZORYVE cream 0.05%$0$0$911.0K

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue9¢$36.7M
  • Research and development20¢$77.1M
  • Selling, general and admin70¢$274.6M
  • Income tax0¢$1.2M

Out of $376.1M in revenue.5 The company lost money this year.

Financial statements

Revenue6785$376.1M in 2025
0$100.0M$200.0M$300.0M$400.0M2020: $0$020202021: $0$020212022: $3.7M$3.7M20222023: $59.6M$59.6M2023+1517%2024: $196.5M$196.5M2024+230%2025: $376.1M$376.1M2025+91%
Operating income96785-$12.2M in 2025−72% since 2019
-$400.0M-$300.0M-$200.0M-$100.0M02019: -$43.1M-$43.1M20192020: -$136.6M-$136.6M2020+217%2021: -$206.5M-$206.5M2021+51%2022: -$301.6M-$301.6M2022+46%2023: -$241.1M-$241.1M2023−20%2024: -$128.4M-$128.4M2024−47%2025: -$12.2M-$12.2M2025−90%
Net income96785-$16.1M in 2025−62% since 2019
-$400.0M-$300.0M-$200.0M-$100.0M02019: -$42.0M-$42.0M20192020: -$135.7M-$135.7M2020+223%2021: -$206.4M-$206.4M2021+52%2022: -$311.5M-$311.5M2022+51%2023: -$262.1M-$262.1M2023−16%2024: -$140.0M-$140.0M2024−47%2025: -$16.1M-$16.1M2025−88%

Every line of the income statement as filed: the last 3 fiscal years, latest first.5

Period ending2025-12-312024-12-312023-12-31
Product revenue, net$372.1M$166.5M$29.2M
Other revenue$4.0M$30.0M$30.4M
Total revenues$376.1M$196.5M$59.6M
Cost of sales$36.7M$19.1M$5.0M
Research and development$77.1M$76.4M$110.6M
Selling, general and administrative$274.6M$229.4M$185.1M
Total operating expenses$388.3M$324.9M$300.7M
Loss from operations-$12.2M-$128.4M-$241.1M
Interest income$8.9M$16.1M$12.5M
Interest expense-$12.1M-$27.2M-$29.7M
Other income (expense), net$443.0K$47.0K-$731.0K
Loss before income taxes-$15.0M-$139.4M-$259.0M
Provision for income taxes$1.2M$647.0K$3.1M
Net loss-$16.1M-$140.0M-$262.1M
Unrealized gain on marketable securities-$206.0K$219.0K$1.2M
Foreign currency translation adjustment$169.0K-$230.0K-$96.0K
Total other comprehensive income (loss)-$37.0K-$11.0K$1.1M
Comprehensive loss-$16.2M-$140.1M-$261.1M
Net loss per share, basic (in USD per share)-$0.13-$1.16-$3.78
Net loss per share, diluted (in USD per share)-$0.13-$1.16-$3.78
Weighted-average shares used in computing net loss per share, basic (in shares)127.2M shares121.0M shares69.3M shares
Weighted-average shares used in computing net loss per share, diluted (in shares)127.2M shares121.0M shares69.3M shares

Compare Arcutis Biotherapeutics, Inc. with another company

Corporate structure

Arcutis Biotherapeutics, Inc. sits at the top of its group. 3 entities, 3 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Arcutis Biotherapeutics, Inc.

  • BlackRock Filed SCHEDULE 13G/A on Arcutis Biotherapeutics, Inc., latest Oct 5, 2026 (7 filings since Feb 3, 2022)
  • Polar Capital Holdings Plc Filed SCHEDULE 13G on Arcutis Biotherapeutics, Inc., latest Aug 14, 2026 (5 filings since Nov 16, 2023)
  • State Street Corporation Filed SCHEDULE 13G on Arcutis Biotherapeutics, Inc., latest Aug 7, 2026 (4 filings since Feb 8, 2023)
  • Prudential Financial Filed SCHEDULE 13G/A on Arcutis Biotherapeutics, Inc., latest May 8, 2026 (5 filings since Nov 9, 2023)
  • JENNISON ASSOCIATES LLC Filed SCHEDULE 13G/A on Arcutis Biotherapeutics, Inc., latest May 6, 2026 (6 filings since Feb 8, 2024)
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on Arcutis Biotherapeutics, Inc., latest Mar 26, 2026 (2 filings since Feb 13, 2024)
  • Rubric Capital Management LP Filed SCHEDULE 13G/A on Arcutis Biotherapeutics, Inc., latest Feb 13, 2026 (3 filings since Feb 12, 2024)
  • Frazier Life Sciences VIII, L.P. Filed SCHEDULE 13D/A on Arcutis Biotherapeutics, Inc., latest Aug 20, 2025 (4 filings since Aug 9, 2022)
  • Point72 Asset Management, L.P. Filed SC 13G/A on Arcutis Biotherapeutics, Inc., latest Nov 14, 2024 (5 filings since Dec 15, 2021)
  • Morgan Stanley Filed SC 13G/A on Arcutis Biotherapeutics, Inc., latest Nov 6, 2024 (2 filings since Feb 12, 2024)
  • MONTANOVA CAPITAL, LLC Filed SC 13G/A on Arcutis Biotherapeutics, Inc., latest Feb 13, 2024 (2 filings since Oct 30, 2023)
  • FMR LLC Filed SC 13G/A on Arcutis Biotherapeutics, Inc., latest Nov 13, 2023 (3 filings since Feb 9, 2022)
  • Arcutis Biotherapeutics, Inc. Westlake Village, California
    • Arcutis Canada, Inc. Subsidiary · Canada
    • Ducentis Biotherapeutics Ltd. Subsidiary · United Kingdom

Built from subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Arcutis Biotherapeutics, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$4.3M5 Dec 31, 2025$3.6M5 Dec 31, 2024+19.0%
Accumulated depreciation$3.2M5 Dec 31, 2025$2.6M5 Dec 31, 2024+26.7%
Property and equipment, net$1.0M5 Dec 31, 2025$1.0M5 Dec 31, 2024+0.2%
Operating-lease assets (leased space)$4.5M5 Dec 31, 2025$2.0M5 Dec 31, 2024+128.7%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$42.9M5 Dec 31, 2025$71.3M5 Dec 31, 2024−39.9%
Marketable securities, current$178.1M5 Dec 31, 2025$156.6M5 Dec 31, 2024+13.7%
Debt securities available for sale$178.1M5 Dec 31, 2025$156.6M5 Dec 31, 2024+13.7%

Intangibles and goodwill

ItemLatestA year beforeChange
Intangible assets, net (excluding goodwill)$14.8M5 Dec 31, 2025$9.5M5 Dec 31, 2024+56.3%
Finite-lived intangibles, net$14.8M5 Dec 31, 2025$9.5M8 Dec 31, 2024+56.3%

Inventory

ItemLatestA year beforeChange
Inventory, total$22.6M5 Dec 31, 2025$14.5M5 Dec 31, 2024+55.8%
Raw materials$5.0M5 Dec 31, 2025$4.3M5 Dec 31, 2024+17.4%
Work in process$5.0M5 Dec 31, 2025$584.0K5 Dec 31, 2024+761.8%
Finished goods$12.6M5 Dec 31, 2025$9.6M5 Dec 31, 2024+30.2%

Properties, in its own words

Our corporate headquarters is located in Westlake Village, California, where we lease 22,643 square feet of office space.

Item 2 of the 10-K filed Feb 25, 2026.4

Leadership

Who has led Arcutis Biotherapeutics, Inc., and when. Pick a name to see everywhere that person has worked.

Board members and other officers (25)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Arcutis Canada, Inc. Canada3
  • Ducentis Biotherapeutics Ltd. United Kingdom3

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Former names

  • Arcutis, Inc.Sep 9, 2019 to Sep 9, 20192

Timeline

  1. Aug 5, 20268-K Results of operations; Executive or director change43
  2. Jul 16, 20268-K Executive or director change; Regulation FD disclosure44
  3. Jun 9, 20268-K Shareholder vote; Other events45
  4. May 6, 20268-K Financial statements and exhibits46
  5. Feb 25, 20268-K Results of operations47
  6. Dec 8, 20258-K Executive or director change; Regulation FD disclosure48
  7. Oct 28, 20258-K Results of operations49
  8. Aug 6, 20258-K Results of operations50
  9. Jun 17, 20258-K Shareholder vote; Other events51
  10. May 6, 20258-K Results of operations52
  11. Apr 10, 20258-K Executive or director change; Regulation FD disclosure53
  12. Feb 25, 20258-K Results of operations54
  13. Feb 4, 2020New chief executive Todd Franklin Watanabe becomes CEO13

Calendar

Coming up

  1. Oct 27, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported $0.06 a share, on Oct 28, 2025.55

When it reported results

  1. Aug 5, 2026Reported quarterly or annual results43
  2. Feb 25, 2026Reported quarterly or annual results47
  3. Oct 28, 2025Reported quarterly or annual results49
  4. Aug 6, 2025Reported quarterly or annual results50
  5. May 6, 2025Reported quarterly or annual results52
  6. Feb 25, 2025Reported quarterly or annual results54
  7. Jan 13, 2025Reported quarterly or annual results56
  8. Nov 6, 2024Reported quarterly or annual results57

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

623 filings to the SEC since October 2021: 7 annual reports, 18 quarterly reports, 50 major events, 297 insider forms, 54 large holders, 197 other. The latest 20:

  1. Oct 15, 2026144 EDGAR
  2. Oct 5, 2026SCHEDULE 13G/A EDGAR
  3. Sep 18, 20264 EDGAR
  4. Sep 17, 20264 EDGAR
  5. Sep 16, 2026144 EDGAR
  6. Sep 15, 2026144 EDGAR
  7. Sep 10, 20264 EDGAR
  8. Sep 8, 2026144 EDGAR
  9. Aug 28, 20264 EDGAR
  10. Aug 27, 2026144 EDGAR
  11. Aug 24, 20264 EDGAR
  12. Aug 21, 20264 EDGAR
  13. Aug 20, 2026144 EDGAR
  14. Aug 19, 20264 EDGAR
  15. Aug 19, 2026144 EDGAR
  16. Aug 17, 2026144 EDGAR
  17. Aug 14, 2026SCHEDULE 13G EDGAR
  18. Aug 13, 20264 EDGAR
  19. Aug 11, 2026144 EDGAR
  20. Aug 7, 2026SCHEDULE 13G EDGAR

The 623 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

245 open-market trades by officers, directors and large owners since October 2021: 18 buys and 227 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 16, 2026Matsuda MasaruSee RemarksSale3,674$25.00$91.8KForm 4
Sep 15, 2026Welgus Howard G.DirectorSale4,730$24.18$114.4KForm 4
Sep 8, 2026Matsuda MasaruSee RemarksSale9,989$25.03$250.0KForm 4
Aug 27, 2026Curran TerrieDirectorSale38,200$25.03$956.1KForm 4
Aug 20, 2026Curran TerrieDirectorSale1,072$26.04$27.9KForm 4
Aug 19, 2026Burnett PatrickSee RemarksSale1,697$27.00$45.8KForm 4
Aug 17, 2026Welgus Howard G.DirectorSale4,730$26.18$123.8KForm 4
Aug 12, 2026Burnett PatrickSee RemarksSale6,700$26.08$174.7KForm 4
Aug 11, 2026Burnett PatrickSee RemarksSale8,300$26.52$220.1KForm 4
Aug 3, 2026Burnett PatrickSee RemarksSale955$26.12$24.9KForm 4
Aug 3, 2026Matsuda MasaruSee RemarksSale1,230$26.12$32.1KForm 4
Aug 3, 2026Watanabe ToddSee RemarksSale4,375$26.12$114.3KForm 4
Jul 15, 2026Welgus Howard G.DirectorSale4,730$26.91$127.3KForm 4
Jun 17, 2026Welgus Howard G.DirectorSale635$25.67$16.3KForm 4
Jun 15, 2026LIN SUE-JEANDirectorSale4,946$24.38$120.6KForm 4
Jun 15, 2026Welgus Howard G.DirectorSale4,096$24.41$100.0KForm 4
May 11, 2026Vairavan LathaSVP Chief Financial OfficerSale435$21.05$9.2KForm 4
May 11, 2026Burnett PatrickSee RemarksSale222$21.05$4.7KForm 4
May 4, 2026Vairavan LathaSVP Chief Financial OfficerSale1,341$23.61$31.7KForm 4
May 4, 2026Watanabe ToddSee RemarksSale3,172$23.61$74.9KForm 4

All 245 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Todd Franklin Watanabe58$713.3K$7.2M72
2025L. Todd Edwards62$535.0K$3.0M72
2025Patrick E. Burnett,$535.0K$3.0M72
2025Masaru MatsudaJ.D.$495.2K$2.1M72
2025David Topper$196.5K$1.9M72
2025Latha Vairavan48$419.5K$1.9M72
2024Former Chief Financial Officer$364.8K$5.3M72
2024President and Chief$660.9K$3.7M72
2024Chief Commercial Officer$516.4K$2.0M72
2024Chief Legal Officer$465.5K$1.7M72
2023Executive Officer$633.5K$4.9M72
2023Chief Medical Officer$477.3K$1.7M72
2023Chief Legal Officer$434.0K$1.6M72

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Montanova Capital, LLC12,437,000$326.1M6.9%+110,000
BlackRock, Inc.10,545,466$276.5M0.0%+1,345,055
Frazier Life Sciences Management, L.P.9,874,511$258.9M5.6%No change
Rubric Capital Management LP8,271,577$216.9M2.0%No change
Polar Capital Holdings Plc6,606,945$173.2M0.5%+940,005
State Street Corp5,822,840$152.7M0.0%−473,357
Vanguard Capital Management LLC4,988,756$130.8M0.0%+117,220
Morgan Stanley4,451,014$116.7M0.0%+232,083
Jennison Associates LLC4,219,058$110.6M0.1%−761,712
D. E. Shaw & Co., Inc.3,949,609$103.6M0.1%+1,453,387
UBS Group AG3,333,015$87.4M0.0%+3,791
Bank Of America Corp /de/2,987,431$78.3M0.0%+766,142
Geode Capital Management, LLC2,982,446$78.2M0.0%−62,860
Vanguard Portfolio Management LLC2,429,005$63.7M0.0%+474,320
Orbimed Advisors LLC2,042,000$53.5M1.0%New
Franklin Resources Inc1,930,982$50.6M0.0%−366,961
American Century Companies Inc1,925,031$50.5M0.0%+461,803
Goldman Sachs Group Inc1,668,367$43.7M0.0%+65,354
Jupiter Topco LLC1,410,435$37.0M0.0%New
Oberweis Asset Management Inc/1,372,941$36.0M0.7%+7,000
Gilder Gagnon Howe & Co LLC1,313,211$34.4M0.4%−2,990,799
Pivotal bioVenture Partners Investment Advisor LLC1,265,283$33.2M10.8%−90,609
Bamco Inc /ny/1,253,120$32.9M0.0%+180,931
Citadel Advisors LLC1,160,014$30.4M0.0%+1,144,408
Federated Hermes, Inc.1,124,629$29.5M0.0%+47,362

13F reports cover disclosed long positions in U.S. stocks only.

Members of Congress who traded it

6 trades disclosed by members of Congress. “Vs S&P since” is the stock’s change since the trade minus the S&P 500’s.

DateMemberTradeAmountVs S&P sinceFiling
May 29, 2026Gilbert Ray Cisneros, Jr.Democratic, HouseBuy$1,001 - $15,000+32.3%Report
Mar 3, 2026Gilbert Ray Cisneros, Jr.Democratic, HouseBuy$1,001 - $15,000+8.7%Report
Dec 11, 2025Gilbert Ray Cisneros, Jr.Democratic, HousePartial sale$1,001 - $15,000+14.2%Report
Sep 15, 2023Josh GottheimerDemocratic, HouseSale$1,001 - $15,000−249.1%Report
Apr 17, 2023Josh GottheimerDemocratic, HouseBuy$1,001 - $15,000+19.7%Report
Jun 15, 2022Josh GottheimerDemocratic, HouseBuy$1,001 - $15,000−63.3%Report

Members report amounts as ranges, not exact figures. Returns are price-only (no dividends).

SEC filer profile

How Arcutis Biotherapeutics, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARArcutis Biotherapeutics, Inc.1
  • CIK0001787306
  • Employer ID (EIN)81-29742554
  • Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company4
  • Incorporated inDelaware4
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address3027 Townsgate Road, Suite 300, Westlake Village, CA 913611
  • Phone805-418-50061
  • Shares outstanding125,691,961 as of Jul 31, 202611
  • Public float$1.5B as of Jun 30, 20254
  • AuditorErnst & Young LLP, Los Angeles, California PCAOB ID 42; it also attests to the company’s internal control over financial reporting4
  • On EDGAR sinceSep 9, 20191
  • Filings849 in all: 4 (392), 144 (153), 8-K (72), 3 (31), 10-Q (20), SC 13G/A (19), SC 13D/A (15), 4/A (14)1
    All 44 form types

    SC 13G (13), SCHEDULE 13G/A (12), UPLOAD (11), 424B5 (10), CORRESP (10), S-8 (8), 10-K (7), DEF 14A (6), DEFA14A (6), 10-Q/A (3), 5 (3), ARS (3), DRS/A (3), EFFECT (3), SC 13D (3), SCHEDULE 13G (3), 10-K/A (2), 3/A (2), 424B4 (2), DRS (2), DRSLTR (2), S-1 (2), S-3ASR (2), SC TO-I/A (2), SEC STAFF LETTER (2), 144/A (1), 8-A12B (1), 8-K/A (1), CERT (1), D (1), S-1/A (1), S-1MEF (1), S-3 (1), SC TO-C (1), SC TO-I (1), SCHEDULE 13D/A (1)

  • Latest filingsAnnual report (10-K) Feb 25, 2026
    Quarterly report (10-Q) Aug 5, 2026
    Proxy statement (DEF 14A) Apr 21, 2026
    Latest 8-K (8-K) Aug 5, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.0001ARQTThe Nasdaq Global Select Market

From the cover page of the 10-K filed Feb 25, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Arcutis Biotherapeutics, Inc. names in Item 1A of its 10-K filed Feb 25, 2026: 73 risks under these headings, as written.4

  • 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.
  • Due to the ongoing commercialization of products approved for commercial sale, and our development strategy and continued development of our pipeline of product candidates through clinical trials, our capital requirements are difficult to predict and may change. We may require substantial additional financing to achieve our goals, and a failure to obtain this necessary capital if or when needed on acceptable terms, or at all, could force us to delay, limit, reduce, or terminate certain operations or efforts.
  • Our operating results may fluctuate significantly, which makes our future operating results difficult to predict, and could cause our future operating results to fall below expectations.
  • Our estimated market opportunities are subject to numerous uncertainties and may prove to be inaccurate. If we have overestimated the size of our market opportunities, our future growth may be limited.
  • 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. If we raise additional capital through debt financing, the terms of any new debt could further restrict our ability to operate our business.
  • Changes in corporate governance policies and practices may impact our business.
  • Risks Related to Development and Commercialization
  • The sales, marketing, and distribution of ZORYVE or any future approved products may be unsuccessful or less successful than anticipated.
  • Our business is dependent on the successful commercialization of ZORYVE and the development, regulatory approval, and commercialization of our current product candidates.
  • Even if our product candidates receive marketing approval, they may fail to achieve market acceptance by physicians, patients, third-party payers, or others in the medical community necessary for commercial success.
  • If we are unable to achieve and maintain third-party payer coverage and adequate levels of reimbursement for ZORYVE or any of our product candidates for which we receive regulatory approval, or any future products we may seek to commercialize, their commercial success may be severely hindered.
The other 62 risks
  • Clinical drug development involves a lengthy and expensive process, with an uncertain outcome. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
  • We may be unable to obtain regulatory approval for an expansion of our product labels or approval of our product candidates under applicable regulatory requirements. The denial or delay of any such approval would prevent or delay commercialization of additional indications or our product candidates and adversely impact our potential to generate revenue, our business, and our results of operations.
  • 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.
  • Certain of the endpoints in our planned clinical trials rely on a subjective assessment of the effect of the product candidate in the subject by either the physician or patient, and may prove difficult to meet in patients with more severe disease, which exposes us to a variety of risks for the successful completion of our clinical trials.
  • Enrollment and retention of subjects in clinical trials is expensive and time-consuming and may result in additional costs and delays in our product development activities, or in the failure of such activities.
  • Serious adverse or unacceptable side effects may be identified during the development of our product candidates, which could prevent or delay regulatory approval and commercialization, increase our costs, or necessitate the abandonment or limitation of the development of some of our product candidates.
  • As a company, we have obtained marketing approval for only four products and we may be unable to successfully obtain marketing approval in a timely manner, or at all, for any of our other product candidates.
  • We may choose not to continue developing or commercializing ZORYVE or any of our product candidates at any time during development or after approval, which would reduce or eliminate our potential return on investment for ZORYVE, and our product candidates.
  • If we seek to market products in countries other than the United States or Canada, we will need to comply with the regulations of each country in which we seek to market our products.
  • Our license agreements and share purchase agreement with Ducentis Biotherapeutics obligate us to make certain milestone and royalty payments, some of which have been or will be triggered prior to commercialization of the applicable product candidates.
  • We face significant competition from other biotechnology and pharmaceutical companies targeting medical dermatological indications, and our operating results will suffer if we fail to compete effectively.
  • Risks Related to Our Business and Operations
  • We may need to increase the size of our organization, and we may experience difficulties in executing our growth strategy, managing any growth, and retaining talent.
  • If we are not successful in acquiring, developing, and commercializing additional product candidates, our ability to expand our business and achieve our strategic objectives would be impaired.
  • Our current and future collaboration arrangements may not be successful, which could adversely affect our ability to develop and commercialize future product candidates.
  • If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of ZORYVE or our current or future product candidates.
  • If we fail to maintain proper and effective internal control over financial reporting, our ability to produce accurate and timely financial statements could be impaired, which could undermine the credibility of our operating results, harm investors’ views of us and, as a result, the value of our common stock.
  • Our business could be negatively affected as a result of actions of activist stockholders, and such activism could impact the trading value of our securities.
  • We depend on our information technology systems, and any failure of these systems, including due to the use of artificial intelligence (AI), or those of our CROs or other contractors or consultants we may utilize, could harm our business. Security breaches, cyber-attacks, loss of data, and other disruptions could compromise sensitive information related to our business or prevent us from accessing critical information and expose us to liability, which could adversely affect our business, results of operations, financial condition, and prospects.
  • Actual or perceived failures to comply with applicable data protection, privacy and security laws, regulations, standards and other requirements could adversely affect our business, results of operations, and financial condition.
  • Failure to comply with anti-corruption and anti-money laundering laws, including the FCPA and similar laws associated with our activities outside of the United States, as well as export and import controls, customs, and economic and trade sanctions laws, could subject us to penalties and other adverse consequences.
  • Our commercial partners, as well as our employees and independent contractors, including principal investigators, consultants, suppliers, service providers, and other vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have an adverse effect on our results of operations.
  • Our business involves the use of hazardous materials and we and our third-party manufacturers and suppliers must comply with environmental laws and regulations, which can be expensive and restrict how we do business.
  • Risks Related to Our Reliance on Third Parties
  • We rely on third-party manufacturers to manufacture nonclinical, clinical and commercial supplies of ZORYVE and our product candidates. The loss of these manufacturers or their sub-suppliers, or their failure to provide us with sufficient quantities at acceptable quality levels, or at all, would materially and adversely affect our business.
  • If our third-party manufacturers fail to comply with manufacturing or other regulations, our financial results and financial condition will be adversely affected.
  • We rely on third parties to conduct our nonclinical studies and our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may be unable to obtain regulatory approval for our product candidates.
  • Risks Related to Intellectual Property
  • We may not be able to obtain, maintain or enforce patent rights or other intellectual property rights that cover ZORYVE or our product candidates and technologies that are of sufficient breadth to prevent third parties from competing against us.
  • We may become subject to claims alleging infringement of third parties’ patents or proprietary rights and/or claims seeking to invalidate our patents, which would be costly, time consuming and, if successfully asserted against us, delay or prevent the development and commercialization of ZORYVE cream 0.3%, ZORYVE cream 0.15%, ZORYVE cream 0.05%, ZORYVE foam, ARQ-234, or any other product candidates.
  • We may be subject to claims by third parties asserting that we, our employees or our licensors have misappropriated their intellectual property, including trade secrets, or claiming ownership of what we regard as our own intellectual property.
  • The validity, scope, and enforceability of any patents listed in the Orange Book that cover ZORYVE cream 0.3%, ZORYVE cream 0.15%, ZORYVE Cream 0.05%, or ZORYVE foam can be challenged by competitors.
  • If we do not obtain protection under the Hatch-Waxman Amendments by extending the patent term of ZORYVE or our product candidates, our business may be materially harmed.
  • Our intellectual property agreements with third parties may be subject to disagreements over contract interpretation, which could narrow the scope of our rights to the relevant intellectual property or technology or increase our financial or other obligations to our licensors.
  • We may need to license additional intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms.
  • We may not be able to protect our intellectual property rights throughout the world.
  • Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for noncompliance with these requirements.
  • If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
  • We will require final regulatory approval of, and registered trademarks for, any commercial tradename and registered trademarks for a commercial trade name for our product candidates in the United States or foreign jurisdictions and failure to secure such approval in a timely fashion could adversely affect our business.
  • If we are unable to protect the confidentiality of our proprietary information and know-how, the value of our technology and products could be adversely affected.
  • If we fail to comply with our obligations under any license, collaboration, or other agreements, we may be required to pay damages and could lose intellectual property rights that are necessary for developing and protecting our product candidates.
  • We may become involved in lawsuits to protect or enforce our patents, or other intellectual property or the patents of our licensors, which could be expensive and time-consuming.
  • Third-party claims or litigation alleging infringement of patents or other proprietary rights, or seeking to invalidate patents or other proprietary rights, may delay or prevent the development and commercialization of any of our product candidates.
  • Risks Related to Government Regulation
  • Even if we receive regulatory approval of our product candidates, we will be subject to extensive and ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense, and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.
  • Disruptions at the FDA and other government agencies caused by funding shortages, staffing limitations, or policy changes could hinder their ability to hire and retain key leadership and other personnel, or otherwise prevent new products and services from being developed or commercialized in a timely manner, which could negatively impact our business.
  • We may be subject to health care laws and regulations relating to our business, and could face substantial penalties if we are determined not to have fully complied with such laws, which would have an adverse impact on our business.
  • We have conducted and may in the future conduct clinical trials for ZORYVE and our product candidates outside the United States and the FDA and applicable foreign regulatory authorities may not accept data from such trials.
  • Recently enacted and future legislation and regulation may increase the difficulty and cost for us to commercialize ZORYVE and to obtain marketing approval of and commercialize our product candidates and affect the prices we may obtain.
  • If we fail to comply with reporting and payment obligations under the Medicaid Drug Rebate Program or other governmental pricing programs in the United States, we could be subject to additional reimbursement requirements, penalties, sanctions and fines, which could have a material adverse effect on our business, results of operations and financial condition.
  • If ZORYVE or any of our product candidates that are approved for marketing are found to have been improperly promoted for off-label uses by us, or if physicians misuse our products or use our products off-label, we may become subject to prohibitions on the sale or marketing of our products, product liability claims and significant fines, penalties and sanctions, and our brand and reputation could be harmed.
  • Risks Related to Our Common Stock
  • Raising additional funds by issuing securities may cause dilution to existing stockholders, raising additional funds through debt financings may involve restrictive covenants, and raising funds through lending and licensing arrangements may restrict our operations or require us to relinquish proprietary rights.
  • Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall.
  • Our ability to utilize our net operating loss carryforwards and research and development income tax credit carryforwards may be limited.
  • Provisions in our corporate charter documents and under Delaware law may prevent or frustrate attempts by our stockholders to change our management and hinder efforts to acquire a controlling interest in us, and the market price of our common stock may be lower as a result.
  • Our restated certificate of incorporation provides that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
  • We do not currently intend to pay dividends on our common stock, and, consequently, your ability to achieve a return on your investment will depend on appreciation in the price of our common stock.
  • General Risk Factors
  • Macroeconomic factors, including unfavorable or uncertain global and regional economic, political and health conditions, could adversely affect our business, financial condition or results of operations.
  • The stock price of our common stock may be volatile or may decline.
  • If securities or industry analysts do not publish research or reports about our business, or if they issue an adverse or misleading opinion regarding our stock, our stock price and trading volume could decline.
  • If we fail to attract and retain management and other key personnel, we may be unable to continue to successfully develop our current and any future product candidates, commercialize ZORYVE or our product candidates or otherwise implement our business plan.
  • We or the third parties upon whom we depend may be adversely affected by earthquakes or other natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
  • Changes in tax laws or regulations could have a material adverse effect on our business and results of operations.
  • We could be subject to additional tax liabilities
  • Future litigation could have a material adverse effect on our business and results of operations.

Legal proceedings

Arcutis Biotherapeutics, Inc. filed a lawsuit against Padagis Israel Pharmaceuticals Ltd., Padagis US LLC, and Padagis LLC (collectively, Padagis) in the U.S. District Court for the District of Delaware on March 27, 2024, based on the submission to the FDA of an ANDA seeking approval to market and sell a generic version of Arcutis’ ZORYVE® 0.3% cream for the treatment of plaque psoriasis. The Company asserts infringement of the following eleven patents, which are listed in the FDA’s Orange Book for Arcutis’ ZORYVE® 0.3% cream: 9,884,050; 9,907,788; 10,940,142; 11,129,818; 11,793,796; 11,819,496; 11,992,480; 12,005,051; 12,005,052; 12,011,437; and 12,016,848 (collectively, Asserted Patents). Arcutis seeks a judgment that Padagis has infringed or will infringe one or more claims of each of the Asserted Patents and based on that judgment, a permanent injunction prohibiting the commercial manufacture, use, offer to sell, or sale within the United States or importation into the United States of Padagis’s proposed generic product before expiration of each of the Asserted Patents found to be infringed.

In March 2025, Arcutis agreed to file a joint stipulation to stay the ongoing patent litigation with Padagis at the request of Padagis. On April 3, 2025, the court stayed the case and cancelled all case deadlines, including the trial. The automatic 30-month stay of FDA approval of Padagis’s ANDA seeking approval for Arcutis’s ZORYVE® 0.3% cream was set to expire on August 14, 2026. The 30-month stay will be extended for each day the stay is in place, starting March 24, 2025, until the stay is lifted.

Teva Pharmaceutical Industries Ltd. filed oppositions with the EPO against two of our European patents in the third quarter of 2024. After oral proceedings for each of the respective patents, the EPO panel found in favor of Arcutis and maintained both patents.

The opening of Item 3, Legal Proceedings.4

Sources

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