WESTLAKE VILLAGE, Calif., Feb. 28, 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 and year ended December 31, 2022, and provided a business update.
“Arcutis’ execution in 2022 was extraordinary, setting us up very well for 2023 and beyond. We are well on our way towards building one of the industry’s leading medical dermatology companies focused on long-term growth from our broad, innovative pipeline,” said Frank Watanabe, Arcutis’ President and Chief Executive Officer. “From June to December last year, we delivered four successful pivotal Phase 3 trial readouts, secured an on-time approval for ZORYVE in plaque psoriasis, and raised nearly $300 million to bolster a strong balance sheet. The momentum around the ZORYVE psoriasis launch continues to build, with confirmatory feedback on our differentiated product profile and access strategy setting the foundation for commercial success in psoriasis as well as our next three indications.”
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 U.S. 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
Fourth Quarter and Full Year 2022 Summary Financial Results
Net product revenues for the quarter ended December 31, 2022 related to sales of ZORYVE were $3.0 million driven by unit demand. Net product revenues for the year ended December 31, 2022 were $3.7 million.
Cost of sales for the quarter ended December 31, 2022 were $0.5 million. Cost of sales for the year ended December 31, 2022 were $0.8 million.
Research and development (R&D) expenses for the quarter ended December 31, 2022 were $33.9 million compared to $52.6 million for the corresponding period in 2021. The year-over-year decrease was primarily due to decreased clinical development costs related to our topical roflumilast program. R&D expenses for the year ended December 31, 2022 were $182.4 million compared to $145.6 million for the corresponding period in 2021. The year-over-year increase for the year was due to the approximately $30 million upfront expense for the Ducentis acquisition in the third quarter of 2022, as well as higher headcount and professional services expenses, partially offset by decreased clinical development costs related to our topical roflumilast and topical JAK1 inhibitor programs.
Selling, general, and administrative (SG&A) expenses for the quarter ended December 31, 2022 were $37.0 million compared to $18.7 million for the corresponding period in 2021. SG&A expenses for the year ended December 31, 2022 were $122.1 million compared to $61.0 million for the corresponding period in 2021. These year-over-year increases were primarily due to higher headcount and professional services expenses related to the launch of ZORYVE.
Net loss was $72.0 million, or $1.18 per basic and diluted share, for the quarter ended December 31, 2022 compared to $71.3 million, or $1.42 per basic and diluted share, for the corresponding period in 2021. Net loss was $311.5 million, or $5.66 per basic and diluted share, for the year ended December 31, 2022 compared to $206.4 million, or $4.18 per basic and diluted share, for the corresponding period in 2021.
Cash, cash equivalents, restricted cash, and marketable securities were $410.8 million as of December 31, 2022, compared to $388.6 million as of December 31, 2021. Net cash used in operating activities was $71.1 during the fourth quarter and $257.7 million during the full year 2022.
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
|December 31,||December 31,|
|Cash and cash equivalents||$||53,641||$||96,449|
|Trade receivable, net||8,458||—|
|Prepaid expenses and other current assets||10,611||14,172|
|Total current assets||437,406||402,773|
|Property and equipment, net||1,881||2,261|
|Intangible assets, net||7,188||—|
|Operating lease right-of-use asset||2,721||3,040|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Operating lease liability||657||433|
|Total current liabilities||37,807||33,326|
|Operating lease liability, noncurrent||4,117||4,774|
|Long-term debt, net||197,769||72,350|
|Other long-term liabilities||—||25|
|Additional paid-in capital||930,425||706,233|
|Accumulated other comprehensive loss||(1,086||)||(255||)|
|Total stockholders’ equity||209,581||297,677|
|Total liabilities and stockholders’ equity||$||449,274||$||408,152|
ARCUTIS BIOTHERAPEUTICS, INC.
Condensed Statements of Operations
(In thousands, except share and per share data)
|Three Months Ended December 31,||Year Ended December 31,|
|Product revenue, net||$||2,961||$||—||$||3,686||$||—|
|Cost of sales||485||—||754||—|
|Research and development||33,877||52,558||182,435||145,558|
|Selling, general, and administrative||37,023||18,728||122,124||60,971|
|Total operating expenses||71,385||71,286||305,313||206,529|
|Loss from operations||(68,424||)||(71,286||)||(301,627||)||(206,529||)|
|Other income (expense):|
|Other income, net||3,320||(40||)||5,821||173|
|Total other income (expense)||(3,595||)||(40||)||(9,831||)||173|
|Per share information:|
|Net loss per share, basic and diluted||$||(1.18||)||$||(1.42||)||$||(5.66||)||$||(4.18||)|
|Weighted-average shares used in computing net loss per share, basic and diluted||60,959,523||50,202,491||55,032,265||49,405,575|