WESTLAKE VILLAGE, Calif., Feb. 22, 2022 (GLOBE NEWSWIRE) — Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported financial results for the quarter and year ended December 31, 2021, and provided a business update.
“We executed exceptionally well in 2021, delivering strong Phase 3 plaque psoriasis data, initiating three additional Phase 3 programs, and commencing our commercialization efforts. We then capped off the year by receiving FDA acceptance of our NDA filing for roflumilast cream in plaque psoriasis and securing a $225 million non-dilutive loan facility to extend our cash runway into 2024,” said Frank Watanabe, Arcutis’ President and Chief Executive Officer. “We have strong momentum and expect that 2022 will be a transformational year for Arcutis, as we prepare for our first potential product launch in plaque psoriasis and progress our three additional Phase 3 topical roflumilast programs, as well as our early pipeline. With the strong team we have built and our financial flexibility enhanced, we can continue to appropriately invest in our mission to advance the treatment of chronic inflammatory skin diseases for patients and healthcare professionals.”
Roflumilast cream – a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor in a once-daily cream formulation, being developed as a potential treatment for plaque psoriasis and atopic dermatitis
Roflumilast foam – an alternative 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-252 – a topical small molecule inhibitor of Janus kinase type 1 (JAK1), being developed as a potential treatment for chronic hand eczema, vitiligo, and other inflammatory dermatoses
ARQ-255 – an alternative topical formulation of ARQ-252 designed to reach deeper into the skin in order to potentially treat alopecia areata
Recent Corporate Highlights
Fourth Quarter and Full Year 2021 Summary Financial Results
Cash, cash equivalents, restricted cash, and marketable securities were $388.6 million as of December 31, 2021, compared to $286.0 million as of December 31, 2020. Arcutis believes that its current cash, cash equivalents, and marketable securities, combined with its committed loan facility, will be sufficient to fund its operations into 2024.
Research and development (R&D) expenses for the quarter ended December 31, 2021 were $52.6 million compared to $27.4 million for the corresponding period in 2020. R&D expenses for the year ended December 31, 2021 were $145.6 million compared to $115.3 million for the corresponding period in 2020. The year-over-year increase for the quarter ended December 31, 2021 was primarily due to increased clinical and manufacturing costs related to the initiation of three additional Phase 3 topical roflumilast development programs. The year-over-year increase for the year ended December 31, 2021 was primarily due to higher headcount to manage our growing clinical programs, as well as increased professional services expenses.
General and administrative (G&A) expenses for the quarter ended December 31, 2021 were $18.7 million compared to $6.7 million for the corresponding period in 2020. G&A expenses for the year ended December 31, 2021 were $61.0 million compared to $21.3 million for the corresponding period in 2020. These year-over-year increases were primarily due to higher headcount and professional services expenses as we prepare for commercialization.
Net loss was $71.3 million, or $1.42 per basic and diluted share, for the quarter ended December 31, 2021 compared to $34.0 million, or $0.79 per basic and diluted share, for the corresponding period in 2020. Net loss was $206.4 million, or $4.18 per basic and diluted share, for the year ended December 31, 2021 compared to $135.7 million, or $3.80 per basic and diluted share, for the corresponding period in 2020.
About Arcutis – Bioscience, applied to the skin.
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a 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 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, with one NDA under review with the FDA and three Phase 3 clinical data readouts anticipated by the end of 2022. The company’s lead program, topical roflumilast, has the potential to advance the standard of care for plaque psoriasis, atopic dermatitis, scalp psoriasis, and seborrheic dermatitis. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn 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; expectations with regard to the timing of data and regulatory events anticipated during 2022; and the Company’s belief that its current cash, cash equivalents, and marketable securities, including the net proceeds from its recent debt financing, will be sufficient to fund its operations into 2024. 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 and expenses of commercialization efforts, 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 22, 2022, 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||$||96,449||$||65,082|
|Prepaid expenses and other current assets||14,172||6,843|
|Total current assets||402,773||292,826|
|Property and equipment, net||2,261||2,016|
|Operating lease right-of-use asset||3,040||3,349|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Operating lease liability||433||—|
|Total current liabilities||33,326||22,602|
|Operating lease liability, noncurrent||4,774||4,964|
|Long-term debt, net||72,350||—|
|Other long-term liabilities||25||82|
|Additional paid-in capital||706,233||472,569|
|Accumulated other comprehensive loss||(255||)||(2||)|
|Total stockholders’ equity||297,677||270,621|
|Total liabilities and stockholders’ equity||$||408,152||$||298,269|
ARCUTIS BIOTHERAPEUTICS, INC.
Condensed Statements of Operations
(In thousands, except share and per share data)
|Three Months Ended December 31,||Year Ended December 31,|
|Research and development||$||52,558||$||27,374||$||145,558||$||115,308|
|General and administrative||18,728||6,690||60,971||21,337|
|Total operating expenses||71,286||34,064||206,529||136,645|
|Loss from operations||(71,286||)||(34,064||)||(206,529||)||(136,645||)|
|Other income, net||(40||)||15||173||967|
|Per share information:|
|Net loss per share, basic and diluted||$||(1.42||)||$||(0.79||)||$||(4.18||)||$||(3.80||)|
|Weighted-average shares used in computing net loss per share, basic and diluted||50,202,491||42,977,244||49,405,575||35,668,152|