WESTLAKE VILLAGE, Calif., May 09, 2023 (GLOBE NEWSWIRE) — Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported financial results for the quarter ended March 31, 2023, and provided a business update.
“We are building momentum in our ongoing launch in psoriasis as a result of ZORYVE’s differentiated product profile, marked by exceptionally positive patient and physician feedback, paired with our ability to secure broad, high-quality formulary coverage. With the recent FDA acceptance of our NDA for seborrheic dermatitis and our upcoming regulatory submissions in atopic dermatitis and scalp and body psoriasis, we look forward to potentially launching a new product every two to three quarters over the next two years, leveraging the commercial infrastructure and positive tailwinds from the clinical experience we’ve built in plaque psoriasis,” said Frank Watanabe, Arcutis’ President and Chief Executive Officer. “Our balance sheet remains strong, and we are further prioritizing capital allocation towards our commercialization efforts in order to drive long-term shareholder value.”
Program Updates / Key Milestones
ZORYVE (roflumilast) 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 under development for atopic dermatitis
Roflumilast 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, being developed as a potential treatment for seborrheic dermatitis and scalp and body psoriasis
ARQ-255 – a topical suspension formulation of ivarmacitinib, a potent and highly selective topical Janus kinase type 1 (JAK1) inhibitor, designed to preferentially deliver the drug deep into the hair follicle, in order to potentially treat alopecia areata at the site of inflammation
ARQ-252 – an alternative topical cream formulation of ivarmacitinib, being developed as a potential treatment for chronic hand eczema, vitiligo, and other inflammatory dermatoses
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
Recent Corporate Highlights
The Health Canada approval of ZORYVE for the treatment of plaque psoriasis marks a significant milestone for Arcutis as our first approval outside of the United States. The Company has built an experienced commercial and medical organization in Canada in preparation of the launch for plaque psoriasis, and to support the continued advancement of our robust pipeline.
First Quarter 2023 Summary Financial Results
Net product revenues for the quarter ended March 31, 2023 related to sales of ZORYVE were $2.8 million driven by strong unit demand, offset by sequentially higher gross-to-net sales deductions, including higher costs of co-pay assistance, in the first quarter compared to the fourth quarter.
Cost of sales for the quarter ended March 31, 2023 were $0.8 million.
Research and development (R&D) expenses for the quarter ended March 31, 2023 were $35.3 million compared to $40.6 million for the corresponding period in 2022. The year-over-year decrease was primarily due to decreased clinical development costs related to our topical roflumilast programs.
Selling, general, and administrative (SG&A) expenses for the quarter ended March 31, 2023 were $42.9 million compared to $22.0 million for the corresponding period in 2022. These year-over-year increases were primarily due to higher headcount and sales and marketing expenses related to the launch of ZORYVE.
Net loss was $80.1 million, or $1.31 per basic and diluted share, for the quarter ended March 31, 2023 compared to $64.3 million, or $1.27 per basic and diluted share, for the corresponding period in 2022.
Cash, cash equivalents, restricted cash, and marketable securities were $333.3 million as of March 31, 2023, compared to $410.8 million as of December 31, 2022. Net cash used in operating activities was $80.3 million during the first quarter.
Conference Call and Webcast
Arcutis management will host a conference call and webcast today at 4:30pm 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.
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is an early commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of patients 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 that harnesses our unique dermatology development platform coupled with our dermatology expertise to build differentiated therapies against biologically validated targets. Arcutis’ dermatology development platform includes a robust pipeline with multiple clinical programs for a range of inflammatory dermatological conditions including scalp and body psoriasis, atopic dermatitis, seborrheic dermatitis, and alopecia areata. For more information, visit https://www.arcutis.com or follow the company on LinkedIn, Facebook, and Twitter.
Forward Looking Statements
This press release contains “forward-looking” statements, including, among others, statements regarding the potential for its topical drugs in development to address large markets with significant unmet need; the development, approval and potential commercialization of Arcutis’ product candidates; expectations with regard to the timing of and successful clinical trial results anticipated during 2023; the potential commercial success and growth of ZORYVE in plaque psoriasis; and the timing of regulatory filings for a number of dermatology indications for roflumilast in the United States and Canada. 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 28, 2023, as well as any subsequent filings with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.
Amanda Sheldon, Head of Corporate Communications
Eric McIntyre, Head of Investor Relations
|ARCUTIS BIOTHERAPEUTICS, INC.
Condensed Balance Sheets
|March 31,||December 31,|
|Cash and cash equivalents||$||81,405||$||53,641|
|Trade receivable, net||12,769||8,458|
|Prepaid expenses and other current assets||13,026||10,611|
|Total current assets||367,676||437,406|
|Property and equipment, net||2,070||1,881|
|Intangible assets, net||7,000||7,188|
|Operating lease right-of-use asset||2,634||2,721|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Operating lease liability||676||657|
|Total current liabilities||37,025||37,807|
|Operating lease liability, noncurrent||3,938||4,117|
|Long-term debt, net||198,763||197,769|
|Additional paid-in capital||940,004||930,425|
|Accumulated other comprehensive loss||(414||)||(1,086||)|
|Total stockholders’ equity||139,732||209,581|
|Total liabilities and stockholders’ equity||$||379,458||$||449,274|
|ARCUTIS BIOTHERAPEUTICS, INC.
Condensed Statements of Operations
|Three Months Ended March 31,|
|Product revenue, net||$||2,781||$||—|
|Cost of sales||783||—|
|Research and development||35,345||40,622|
|Selling, general, and administrative||42,918||22,006|
|Total operating expenses||79,046||62,628|
|Loss from operations||(76,265||)||(62,628||)|
|Other income (expense):|
|Other income, net||3,207||142|
|Total other income (expense)||(3,835||)||(1,696||)|
|Per share information:|
|Net loss per share, basic and diluted||$||(1.31||)||$||(1.27||)|
|Weighted-average shares used in computing net loss per share, basic and diluted||61,169,089||50,513,524|