WESTLAKE VILLAGE, Calif., Aug. 04, 2022 (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 June 30, 2022, and provided a business update.
“The FDA approval of ZORYVE for the treatment of plaque psoriasis is a pivotal milestone for the Arcutis organization, and for dermatologists and people suffering from psoriasis, who have long-awaited an innovative, steroid-free treatment option for chronic use on all affected areas of the body,” said Frank Watanabe, Arcutis’ President and Chief Executive Officer. “Our organization is well prepared and excited to launch ZORYVE in the coming weeks and we have bolstered our financial strength on the back of this approval. At the same time, we continue to execute on each of our Phase 3 development programs, progressing towards topline clinical data readouts in atopic dermatitis and scalp and body psoriasis later this year, as well as the NDA submission for seborrheic dermatitis early in 2023.”
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-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
Second Quarter 2022 Summary Financial Results
Cash, cash equivalents, restricted cash, and marketable securities were $283.4 million as of June 30, 2022, compared to $388.6 million as of December 31, 2021. These resources, combined with the expected $162 million in net proceeds from its August 2022 equity financing and the $125 million drawn from its existing loan facility, will provide for capital resources of approximately $570 million to support the launch and commercialization efforts for ZORYVE, as well as continue to advance the Company’s pipeline development initiatives.
Research and development (R&D) expenses for the quarter ended June 30, 2022 were $38.2 million compared to $30.8 million for the corresponding period in 2021. The year-over-year increase was primarily due to higher headcount and professional services expenses.
General and administrative (G&A) expenses for the quarter ended June 30, 2022 were $27.6 million compared to $11.3 million for the corresponding period in 2021. The year-over-year increase was primarily due to higher headcount and professional services expenses as we prepare for commercialization.
Net loss was $67.4 million, or $1.31 per basic and diluted share, for the quarter ended June 30, 2022 compared to $42.0 million, or $0.84 per basic and diluted share, for the corresponding period in 2021.
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 including plaque psoriasis, atopic dermatitis, and seborrheic dermatitis. For more information, visit www.arcutis.com or follow Arcutis 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; expectations with regard to the timing of clinical trial results and regulatory events anticipated during 2022; the anticipated successful commercial launch of ZORYVE in plaquepsoriasis; 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, expenses and success of our 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
|June 30,||December 31,|
|Cash and cash equivalents||$||61,512||$||96,449|
|Prepaid expenses and other current assets||12,024||14,172|
|Total current assets||295,426||402,773|
|Property and equipment, net||2,078||2,261|
|Operating lease right-of-use asset||2,882||3,040|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Operating lease liability||582||433|
|Total current liabilities||27,482||33,326|
|Operating lease liability, noncurrent||4,450||4,774|
|Long-term debt, net||73,138||72,350|
|Other long-term liabilities||12||25|
|Additional paid-in capital||736,665||706,233|
|Accumulated other comprehensive loss||(1,252||)||(255||)|
|Total stockholders’ equity||195,382||297,677|
|Total liabilities and stockholders’ equity||$||300,464||$||408,152|
|ARCUTIS BIOTHERAPEUTICS, INC.|
|Condensed Statements of Operations
(In thousands, except share and per share data)
|Three Months Ended June 30,||Six Months Ended June 30,|
|Research and development||$||38,205||$||30,765||$||78,827||$||52,396|
|General and administrative||27,622||11,315||49,628||25,769|
|Total operating expenses||65,827||42,080||128,455||78,165|
|Loss from operations||(65,827||)||(42,080||)||(128,455||)||(78,165||)|
|Other income (expense):|
|Other income, net||421||72||563||115|
|Total other income (expense)||(1,579||)||72||$||(3,275||)||$||115|
|Per share information:|
|Net loss per share, basic and diluted||$||(1.31||)||$||(0.84||)||$||(2.58||)||$||(1.60||)|
|Weighted-average shares used in computing net loss per share, basic and diluted||51,422,386||50,000,716||50,970,465||48,648,262|