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WESTLAKE VILLAGE, Calif., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported financial results for the quarter ended June 30, 2025, and provided a business update.
“We continue to advance our strategy to become the leading medical dermatology company. This quarter, we generated strong net product revenues of $81.5 million from our ZORYVE portfolio, launched a new indication for ZORYVE foam for scalp and body psoriasis, and continued to advance our pipeline. Demand for ZORYVE continues to grow steadily, and we recently surpassed 1 million prescriptions dispensed, underscoring clinicians’ trust in ZORYVE as their preferred steroid-free topical treatment across our four approved indications, thanks to its consistent, robust efficacy and favorable safety and tolerability,” said Frank Watanabe, president and chief executive officer. “Looking ahead, we remain focused on expanding the approved uses of ZORYVE to the youngest patients, with the potential Q4 approval of ZORYVE cream 0.05% for 2 to 5 year olds with atopic dermatitis and the initiation of an infant atopic dermatitis study. Together with our efforts to evaluate potential further indications for ZORYVE and the continued advancement of ARQ-234, we are well positioned for long-term, sustainable growth.”
Program Updates / Key Milestones
ZORYVE cream - a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor in a once-daily cream formulation, approved in the United States for the treatment of plaque psoriasis and atopic dermatitis.
ZORYVE foam - a once-daily foam formulation of topical roflumilast designed to overcome the challenges of delivering topical drugs in hair-bearing areas of the body, approved in the United States for the treatment of seborrheic dermatitis and plaque psoriasis of the scalp and body.
ARQ-234 - a fusion protein that is a potent and highly selective checkpoint agonist of the CD200 Receptor (CD200R), being developed as a potential biologic treatment in atopic dermatitis.
Other Pipeline Updates
Recent Corporate Highlights
Second Quarter 2025 Summary Financial Results
Product revenues for the quarter ended June 30, 2025 were $81.5 million compared to $30.9 million for the corresponding period in 2024. Revenues for the quarter were $27.7 million for ZORYVE cream 0.3%, $14.6 million for ZORYVE cream 0.15%, and $39.2 million for ZORYVE topical foam 0.3%. Year-over-year and quarter-over-quarter increases were due to increased unit demand. Gross-to-net (GTN) rates remain favorable for ZORYVE, driven by a high percentage of prescriptions being reimbursed.
Cost of sales for the quarter ended June 30, 2025 were $7.5 million compared to $3.5 million for the corresponding period in 2024 due to increasing ZORYVE sales.
Research and development (R&D) expenses for the quarter ended June 30, 2025 were $19.5 million compared to $19.3 million for the corresponding period in 2024. Expenses remained consistent year-over-year as decreased development costs for roflumilast in adult atopic dermatitis and plaque psoriasis were partially offset by an increase in development costs for pediatric atopic dermatitis and continued medical affairs investments to support medical education.
Selling, general, and administrative (SG&A) expenses for the quarter ended June 30, 2025 were $69.2 million compared to $58.2 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 our continued commercialization efforts for ZORYVE.
Net loss was $15.9 million, or $0.13 per basic and diluted share, for the quarter ended June 30, 2025 compared to $52.3 million, or $0.42 per basic and diluted share, for the corresponding period in 2024.
Cash, cash equivalents, restricted cash, and marketable securities were $191.1 million as of June 30, 2025, compared to $228.6 million as of December 31, 2024. Net cash provided by operating activities was $0.3 million during the second quarter as increased gross profit and timing changes in net working capital reduced cash used in operations. The company made the $10.0 million cash milestone payment to AstraZeneca for reaching a sales milestone of $250 million that was incurred in the first quarter of 2025, which is included as an investing activity.
Conference Call and Webcast
Arcutis management will host a conference call and webcast today at 4:30 PM ET to discuss the financial results for the quarter and provide a business update. The webcast for this conference call may 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 call.
About Arcutis
Arcutis 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 invent differentiated therapies against biologically validated targets, and has produced a robust pipeline for inflammatory dermatological conditions. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram and X.
Forward Looking Statements
This 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; the potential commercial success and growth of ZORYVE in plaque psoriasis, seborrheic dermatitis, and atopic dermatitis, including 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.
Contacts:
Media
Amanda Sheldon, Head of Corporate Communications
[email protected]
Investors
Brian Schoelkopf, Head of Investor Relations
[email protected]
ARCUTIS BIOTHERAPEUTICS, INC. Condensed Consolidated Balance Sheets (In thousands) (unaudited) | |||||||
June 30, | December 31, | ||||||
2025 | 2024 | ||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 72,740 | $ | 71,335 | |||
Restricted cash | 308 | 617 | |||||
Marketable securities | 118,083 | 156,620 | |||||
Trade receivable, net | 106,688 | 73,066 | |||||
Inventories | 16,324 | 14,526 | |||||
Prepaid expenses and other current assets | 18,635 | 19,656 | |||||
Total current assets | 332,778 | 335,820 | |||||
Property and equipment, net | 1,394 | 1,041 | |||||
Intangible assets, net | 15,937 | 9,479 | |||||
Operating lease right-of-use asset | 1,728 | 1,953 | |||||
Other assets | 596 | 596 | |||||
Total assets | $ | 352,433 | $ | 348,889 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 15,082 | $ | 14,220 | |||
Current portion of long-term debt, net | 1,000 | — | |||||
Accrued and other current liabilities | 87,854 | 66,793 | |||||
Total current liabilities | 103,936 | 81,013 | |||||
Operating lease liability, noncurrent | 2,114 | 2,562 | |||||
Long-term debt, net | 107,049 | 107,203 | |||||
Other long-term liabilities | 360 | 570 | |||||
Total liabilities | 213,459 | 191,348 | |||||
Stockholders’ equity: | |||||||
Common stock | 12 | 12 | |||||
Additional paid-in capital | 1,301,886 | 1,279,479 | |||||
Accumulated other comprehensive loss | (35 | ) | (7 | ) | |||
Accumulated deficit | (1,162,889 | ) | (1,121,943 | ) | |||
Total stockholders’ equity | 138,974 | 157,541 | |||||
Total liabilities and stockholders’ equity | $ | 352,433 | $ | 348,889 |
ARCUTIS BIOTHERAPEUTICS, INC. Condensed Consolidated Statements of Operations (In thousands, except per share data) (unaudited) | |||||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
2025 | 2024 | 2025 | 2024 | ||||||||||||
Revenues: | |||||||||||||||
Product revenue, net | $ | 81,504 | $ | 30,858 | $ | 145,350 | $ | 52,427 | |||||||
Other revenue | — | — | 2,000 | 28,000 | |||||||||||
Total revenues | 81,504 | 30,858 | 147,350 | 80,427 | |||||||||||
Operating expenses: | |||||||||||||||
Cost of sales | 7,492 | 3,464 | 16,322 | 6,720 | |||||||||||
Research and development | 19,453 | 19,298 | 36,996 | 42,439 | |||||||||||
Selling, general, and administrative | 69,170 | 58,173 | 133,172 | 112,967 | |||||||||||
Total operating expenses | 96,115 | 80,935 | 186,490 | 162,126 | |||||||||||
Loss from operations | (14,611 | ) | (50,077 | ) | (39,140 | ) | (81,699 | ) | |||||||
Other income (expense): | |||||||||||||||
Other income, net | 2,096 | 5,229 | 4,826 | 9,273 | |||||||||||
Interest expense | (3,029 | ) | (7,484 | ) | (6,011 | ) | (14,964 | ) | |||||||
Loss before income taxes | (15,544 | ) | (52,332 | ) | (40,325 | ) | (87,390 | ) | |||||||
Provision for income taxes | 342 | — | 621 | 324 | |||||||||||
Net loss | $ | (15,886 | ) | $ | (52,332 | ) | $ | (40,946 | ) | $ | (87,714 | ) | |||
Per share information: | |||||||||||||||
Net loss per share, basic and diluted | $ | (0.13 | ) | $ | (0.42 | ) | $ | (0.32 | ) | $ | (0.75 | ) | |||
Weighted-average shares used in computing net loss per share, basic and diluted | 126,997 | 123,481 | 126,519 | 117,265 |
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