Full Press Release Details
WESTLAKE VILLAGE, Calif., Oct. 28, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today outlined its strategy to achieve sustainable growth and reported financial results for the quarter ended September 30, 2025. Arcutis will review both topics at its Investor Day, which begins today at 10:30 a.m. Eastern Time (ET).
“Over the past nine years, we have built Arcutis into an undisputed leader in medical dermatology. With ZORYVE, we have developed a portfolio of revolutionary topical treatments that are reshaping the treatment of chronic inflammatory skin diseases and demonstrating sustainable commercial momentum across all strengths and indications,” said Frank Watanabe, president and chief executive officer. “This success provides a tremendous foundation for sustained, long-term growth—offering the opportunity to reinvest in the ZORYVE franchise, systematically evaluate new opportunities, and expand our pipeline with new molecules that leverage our deep expertise in dermatology, as well as our best-in-class development and commercialization capabilities.”
In today's Investor Day presentation, Arcutis management will discuss how the Company intends to:
Third Quarter 2025 Financial Results and Business Updates
Commercial Highlights
ZORYVE- a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor in once-daily cream and foam formulations, approved in the United States for the treatment of plaque psoriasis, atopic dermatitis, and seborrheic dermatitis.
Clinical and Regulatory Developments
Corporate Updates
Third Quarter 2025 Summary Financial Results
Product revenuesfor the quarter ended September 30, 2025 were $99.2 million compared to $44.8 million for the corresponding period in 2024. Revenues for the quarter were $30.5 million for ZORYVE cream 0.3%, $18.9 million for ZORYVE cream 0.15%, and $49.8 million for ZORYVE topical foam 0.3%. The year-over-year increase was primarily due to increased unit demand. GTN rates remained favorable for ZORYVE, driven by a high percentage of prescriptions being reimbursed.
Cost of salesfor the quarter ended September 30, 2025 was $8.7 million compared to $5.5 million for the corresponding period in 2024, due to increasing ZORYVE sales.
Research and development (R&D) expensesfor the quarter ended September 30, 2025 were $19.6 million compared to $19.5 million for the corresponding period in 2024. Expenses remained consistent year over year, as increased development costs for roflumilast in pediatric atopic dermatitis were largely offset by a decrease in development costs for ARQ-255 and preclinical expenses.
Selling, general, and administrative (SG&A) expensesfor the quarter ended September 30, 2025 were $62.4 million compared to $58.8 million for the corresponding period in 2024. The year-over-year increase was primarily driven by increased sales and marketing and personnel-related expenses due to the Company's continued commercialization efforts for ZORYVE.
Net incomewas $7.4 million, or $0.06 per basic and diluted earnings per share, for the quarter ended September 30, 2025 compared to a net loss of $41.5 million, or $0.33 per basic and diluted loss per share, for the corresponding period in 2024.
Cash, cash equivalents, restricted cash, and marketable securitieswere $191.4 million as of September 30, 2025, compared to $228.6 million as of December 31, 2024. Net cash used in operating activities was $1.8 million during the third quarter.
Financial Guidance
Conference Call and WebcastArcutis management will host a virtual Investor Day today at 10:30 a.m. ET to discuss its strategy for sustained long-term growth, as well as financial results for the third quarter. The webcast for this event can be accessed at the “Events” section of the Company’s website. The replay of the webcast will be available on the Arcutis website following the event.
About ArcutisArcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio of advanced targeted topicals approved to treat three major inflammatory skin diseases. Arcutis’ unique dermatology development platform coupled with our dermatology expertise allows us to develop differentiated therapies against biologically validated targets, and has produced a robust pipeline for a range of inflammatory dermatological conditions. For more information, visitwww.arcutis.comor follow Arcutis onLinkedIn,Facebook,InstagramandX
Forward Looking StatementsThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. For example, statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential to address large markets with significant unmet need; the development, approval, and potential commercialization of product candidates and expanded indications; the potential commercial success and growth of ZORYVE in plaque psoriasis, seborrheic dermatitis, and atopic dermatitis, including peak sales, market access and reimbursement, product demand growth and developments regarding GTN; and the timing of regulatory filings and potential approvals. These statements involve substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements and you should not place undue reliance on our forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in the clinical development process and regulatory approval process, the timing of regulatory filings, the timing, expenses, and success of our commercialization efforts, including uncertainty of future commercial sales and related items that can impact net sales, and our ability to defend our intellectual property. For a further description of the risks and uncertainties applicable to our business, see the “Risk Factors” section of our Form 10-K filed with U.S. Securities and Exchange Commission (SEC) on February 25, 2025, as well as any subsequent filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, we undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.
MediaAmanda Sheldon, Head of Corporate Communicationsmedia@arcutis.com
InvestorsBrian Schoelkopf, Head of Investor Relationsir@arcutis.com
| ARCUTIS BIOTHERAPEUTICS, INC.Condensed Consolidated Balance Sheets(In thousands)(unaudited) | |||||||
| September 30, | December 31, | ||||||
| 2025 | 2024 | ||||||
| ASSETS | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 47,120 | $ | 71,335 | |||
| Restricted cash | 308 | 617 | |||||
| Marketable securities | 143,948 | 156,620 | |||||
| Trade receivable, net | 115,116 | 73,066 | |||||
| Inventories | 22,419 | 14,526 | |||||
| Prepaid expenses and other current assets | 20,313 | 19,656 | |||||
| Total current assets | 349,224 | 335,820 | |||||
| Property and equipment, net | 1,215 | 1,041 | |||||
| Intangible assets, net | 15,375 | 9,479 | |||||
| Operating lease right-of-use asset | 4,567 | 1,953 | |||||
| Other assets | 596 | 596 | |||||
| Total assets | $ | 370,977 | $ | 348,889 | |||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 5,795 | $ | 14,220 | |||
| Current portion of long-term debt, net | 1,000 | — | |||||
| Accrued and other current liabilities | 92,975 | 66,793 | |||||
| Total current liabilities | 99,770 | 81,013 | |||||
| Operating lease liability, noncurrent | 5,276 | 2,562 | |||||
| Long-term debt, net | 107,498 | 107,203 | |||||
| Other long-term liabilities | 360 | 570 | |||||
| Total liabilities | 212,904 | 191,348 | |||||
| Stockholders’ equity: | |||||||
| Common stock | 12 | 12 | |||||
| Additional paid-in capital | 1,313,602 | 1,279,479 | |||||
| Accumulated other comprehensive loss | (62 | ) | (7 | ) | |||
| Accumulated deficit | (1,155,479 | ) | (1,121,943 | ) | |||
| Total stockholders’ equity | 158,073 | 157,541 | |||||
| Total liabilities and stockholders’ equity | $ | 370,977 | $ | 348,889 |
| ARCUTIS BIOTHERAPEUTICS, INC.Condensed Consolidated Statements of Operations(In thousands, except per share data)(unaudited) | |||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||
| Revenues: | |||||||||||||||
| Product revenue, net | $ | 99,219 | $ | 44,755 | $ | 244,569 | $ | 97,182 | |||||||
| Other revenue | — | — | 2,000 | 28,000 | |||||||||||
| Total revenues | 99,219 | 44,755 | 246,569 | 125,182 | |||||||||||
| Operating expenses: | |||||||||||||||
| Cost of sales | 8,685 | 5,503 | 25,007 | 12,223 | |||||||||||
| Research and development | 19,604 | 19,501 | 56,600 | 61,940 | |||||||||||
| Selling, general, and administrative | 62,404 | 58,817 | 195,576 | 171,784 | |||||||||||
| Total operating expenses | 90,693 | 83,821 | 277,183 | 245,947 | |||||||||||
| Income (loss) from operations | 8,526 | (39,066 | ) | (30,614 | ) | (120,765 | ) | ||||||||
| Other income (expense): | |||||||||||||||
| Other income, net | 2,035 | 4,182 | 6,861 | 13,455 | |||||||||||
| Interest expense | (3,071 | ) | (6,653 | ) | (9,082 | ) | (21,617 | ) | |||||||
| Income (loss) before income taxes | 7,490 | (41,537 | ) | (32,835 | ) | (128,927 | ) | ||||||||
| Provision for income taxes | 80 | — | 701 | 324 | |||||||||||
| Net income (loss) | $ | 7,410 | $ | (41,537 | ) | $ | (33,536 | ) | $ | (129,251 | ) | ||||
| Earnings (loss) per share: | |||||||||||||||
| Basic | $ | 0.06 | $ | (0.33 | ) | $ | (0.26 | ) | $ | (1.08 | ) | ||||
| Diluted | $ | 0.06 | $ | (0.33 | ) | $ | (0.26 | ) | $ | (1.08 | ) | ||||
| Weighted-average shares used in computing earnings (loss) per share: | |||||||||||||||
| Basic | 127,623 | 124,302 | 126,891 | 119,628 | |||||||||||
| Diluted | 132,885 | 124,302 | 126,891 | 119,628 |