FALSE000178730600017873062024-05-142024-05-14

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
___________________________________________
FORM 8-K
___________________________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 14, 2024
___________________________________________
ARCUTIS BIOTHERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
___________________________________________
Delaware
001-39186
81-2974255
(State or other jurisdiction
of incorporation)
(Commission
File Number)
(IRS Employer
Identification Number)
3027 Townsgate Road, Suite300
Westlake Village, CA 91361
(Address of principal executive offices, including Zip Code)
Registrant’s telephone number, including area code: (805) 418-5006
___________________________________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below):
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading
Symbol(s)
Name of each exchange
on which registered
Common Stock, par value $0.0001 per share
ARQT
The Nasdaq Global Select Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter). Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐


Item 2.02    Results of Operations and Financial Condition.
On May 14, 2024, Arcutis Biotherapeutics, Inc. (the “Company” or “Arcutis”) issued a press release relating to its financial results for the quarter ended March 31, 2024. The full text of the press release is furnished herewith as Exhibit 99.1.
The information in this Item 2.02 of this Form 8-K and the Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, or incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item 9.01    Financial Statements and Exhibits
(d)    Exhibits.
Exhibit No.
Description
99.1
104Cover Page Interactive Data File (formatted as Inline XBRL).


SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
ARCUTIS BIOTHERAPEUTICS, INC.
May 14, 2024
By:
/s/ David Topper
David Topper
Chief Financial Officer

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Arcutis Announces First Quarter 2024 Financial Results and Provides Business Update
•First quarter net product revenues for ZORYVE® franchise of $21.6M, with $15M for ZORYVE (roflumilast) cream 0.3%, and $6.5M for ZORYVE (roflumilast) topical foam, 0.3%; sales growth of 675% vs. Q1 '23 and 59% vs. Q4 '23
•Continued gross-to-net (GTN) improvement with blended GTN across products now in the low 60 percent range
•Sustained growth in demand for cream and remarkable uptake of foam launched in January
•July 7, 2024 Prescription Drug User Fee Act (PDUFA) action date for roflumilast cream, 0.15%, for treatment of mild to moderate atopic dermatitis in adults and children down to age 6
•Strong cash position following a public offering raising gross proceeds of $172.5 million and a strategic licensing agreement in Japan
Westlake Village, CA, May 14, 2024 – 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 March 31, 2024, and provided a business update.

“Our strong performance in the first quarter, with the incredibly well received launch of ZORYVE foam for seborrheic dermatitis, and continued growth of ZORYVE cream in psoriasis, reinforces the demand for new and novel steroid-free treatment options and physician adoption of the ZORYVE portfolio,” said Frank Watanabe, president and chief executive officer. “The growth of ZORYVE cream and foam, along with a July 7th PDUFA date for ZORYVE cream as a potential treatment for atopic dermatitis, as well as our robust development pipeline, position Arcutis for a potentially transformative year in 2024.”
3027 Townsgate Road, Suite 300 Westlake Village, CA 91361 | arcutis.com
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Program Updates / Key Milestones
Roflumilast cream - a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor in a once-daily cream formulation, approved in the United States and Canada for the treatment of plaque psoriasis and under development for atopic dermatitis
•Demand for ZORYVE cream in plaque psoriasis continues to grow, with over 208,000 prescriptions filled to date since launch by close to 12,000 unique prescribers, reflecting the high levels of patient and physician satisfaction with the ZORYVE cream clinical profile. ZORYVE cream is covered by the three largest Pharmacy Benefit Managers and multiple other commercial insurers, and the Company anticipates beginning to obtain Medicare and Medicaid coverage during 2024. The Company experienced another significant GTN improvement in the first quarter compared to Q4 '23, and anticipates additional GTN improvement throughout 2024 as GTN for the cream approaches steady state.
•The Food & Drug Administration (FDA) has accepted the Company’s supplemental new drug application (sNDA) for roflumilast cream 0.15% for the treatment of mild to moderate atopic dermatitis in adults and children down to age 6, and assigned the application a PDUFA target action date of July 07, 2024. The sNDA is supported by positive results from three Phase 3 studies as well as a Phase 2 dose ranging study, and two Phase 1 pharmacokinetic studies.
3027 Townsgate Road, Suite 300 Westlake Village, CA 91361 | arcutis.com
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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, approved in the United States for the treatment of seborrheic dermatitis and in development for scalp and body psoriasis
•The launch in January of ZORYVE foam in seborrheic dermatitis has been incredibly well received by healthcare providers and patients, with over 46,000 prescriptions filled since launch, reflecting the high unmet need in this disease. ZORYVE foam is also covered by the three largest Pharmacy Benefit Managers. For the partial first quarter of launch, GTN is favorable and improving rapidly.
•Based on the positive topline results from the ARRECTOR pivotal Phase 3 trial for the treatment of scalp and body psoriasis, the Company anticipates submitting an sNDA for scalp and body psoriasis to the FDA in the third quarter of 2024.
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
•In December 2022, Arcutis announced the enrollment of the first healthy volunteer subject in a Phase 1b study in alopecia areata. The first subject in the alopecia areata cohort enrolled in the second quarter of 2023.
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
•The Company continues preclinical development efforts.
3027 Townsgate Road, Suite 300 Westlake Village, CA 91361 | arcutis.com
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Recent Corporate Highlights 
•In February, the Company completed a public offering raising gross proceeds of $172.5 million including the underwriters' 30-day option to purchase additional shares at the public offering price per share, which was fully exercised.
•In February, the Company announced a strategic collaboration and licensing agreement for the development, manufacture, and commercialization of topical roflumilast in Japan with Sato Pharmaceutical Co., Ltd.
•In April, the Company announced David Topper has been appointed Chief Financial Officer (CFO) effective April 10, 2024. He replaced John Smither, who had rejoined Arcutis as interim CFO in August 2023.

3027 Townsgate Road, Suite 300 Westlake Village, CA 91361 | arcutis.com
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First Quarter 2024 Summary Financial Results
Product revenues for the quarter ended March 31, 2024 were $21.6 million compared to $2.8 million for the corresponding period in 2023. Revenues for the quarter were $15.0 million for ZORYVE (roflumilast) cream 0.3% and $6.5 million for ZORYVE (roflumilast) topical foam, 0.3%. Year-over-year increases were due to strong unit demand as well as improvements in GTN sales deductions. In addition, the first quarter of 2024 included Other revenues of $28.0 million related to the upfront and milestone payments in connection with the Sato Pharmaceutical and Huadong Pharmaceutical collaboration and licensing agreements.
Cost of sales for the quarter ended March 31, 2024 were $3.3 million compared to $0.8 million for the corresponding period in 2023.
Research and development (R&D) expenses for the quarter ended March 31, 2024 were $23.1 million compared to $35.3 million for the corresponding period in 2023. The year-over-year decrease was due to decreased clinical development costs related to our topical roflumilast program.
Selling, general, and administrative (SG&A) expenses for the quarter ended March 31, 2024 were $54.8 million compared to $42.9 million for the corresponding period in 2023. The year-over-year increase was primarily due to sales and marketing expenses related to the launches of ZORYVE cream and foam.
Net loss was $35.4 million, or $0.32 per basic and diluted share, for the quarter ended March 31, 2024 compared to $80.1 million, or $1.31 per basic and diluted share, for the corresponding period in 2023.
Cash, cash equivalents, restricted cash, and marketable securities were $404.5 million as of March 31, 2024, compared to $272.8 million as of December 31, 2023. Net cash used in operating activities was $31.6 million during the first quarter.
3027 Townsgate Road, Suite 300 Westlake Village, CA 91361 | arcutis.com
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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 including two FDA approved products 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, and alopecia areata. For more information, visit https://www.arcutis.com or follow Arcutis on LinkedIn, Facebook, and X.

3027 Townsgate Road, Suite 300 Westlake Village, CA 91361 | arcutis.com
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Forward Looking Statements
Arcutis cautions you that 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 for its topical drugs in development to address large markets with significant unmet need; the development, approval and potential commercialization of Arcutis' product candidates; the potential continued commercial success and growth of ZORYVE cream in plaque psoriasis and ZORYVE foam in seborrheic dermatitis, including market access and reimbursement, product demand growth and continued improvement in gross to net; and the timing of regulatory filings and potential approvals 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 27, 2024, 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.

3027 Townsgate Road, Suite 300 Westlake Village, CA 91361 | arcutis.com
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Contacts:

Media
Amanda Sheldon, Head of Corporate Communications
asheldon@arcutis.com

Investors
Latha Vairavan, VP Finance and Head of Investor Relations
lvairavan@arcutis.com

Derek Cole
derek.cole@iradvisory.com

3027 Townsgate Road, Suite 300 Westlake Village, CA 91361 | arcutis.com
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ARCUTIS BIOTHERAPEUTICS, INC.
Condensed Consolidated Balance Sheets
(In thousands)
March 31,December 31,
20242023
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents
$190,097 $88,398 
Restricted cash617 925 
Marketable securities213,769 183,463 
Trade receivable, net37,154 25,807 
Inventories13,247 13,134 
Prepaid expenses and other current assets
13,178 18,704 
Total current assets
468,062 330,431 
Property and equipment, net1,369 1,539 
Intangible assets, net6,250 6,438 
Operating lease right-of-use asset
2,264 2,361 
Other assets
596 596 
Total assets
$478,541 $341,365 
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$12,969 $11,992 
Accrued liabilities
33,584 33,941 
Operating lease liability
756 735 
Total current liabilities
47,309 46,668 
Operating lease liability, noncurrent
3,181 3,382 
Long-term debt, net202,803 201,799 
Other long-term liabilities306 849 
Total liabilities
253,599 252,698 
Stockholders’ equity:
Common stock12 9 
Additional paid-in capital
1,242,349 1,070,558 
Accumulated other comprehensive loss(133)4 
Accumulated deficit
(1,017,286)(981,904)
Total stockholders’ equity224,942 88,667 
Total liabilities and stockholders’ equity$478,541 $341,365 
3027 Townsgate Road, Suite 300 Westlake Village, CA 91361 | arcutis.com
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ARCUTIS BIOTHERAPEUTICS, INC.
Condensed Consolidated Statements of Operations
(In thousands, except share and per share data)
(unaudited)

Three Months Ended March 31,
20242023
Revenues:
Product revenue, net$21,569 $2,781 
Other revenue28,000 — 
Total revenues49,569 2,781 
Operating expenses:
Cost of sales3,256 783 
Research and development23,141 35,345 
Selling, general, and administrative54,794 42,918 
Total operating expenses81,191 79,046 
Loss from operations(31,622)(76,265)
Other income (expense):
Other income, net4,044 3,207 
Interest expense(7,480)(7,042)
Loss before income taxes
(35,058)(80,100)
Provision for income taxes
$324 $— 
Net loss$(35,382)$(80,100)
Per share information:
Net loss per share, basic and diluted$(0.32)$(1.31)
Weighted-average shares used in computing net loss per share, basic and diluted111,048,525 61,169,089 
3027 Townsgate Road, Suite 300 Westlake Village, CA 91361 | arcutis.com
v3.24.1.1.u2
Cover
May 14, 2024
Cover [Abstract]  
Document Type 8-K
Document Period End Date May 14, 2024
Entity Registrant Name ARCUTIS BIOTHERAPEUTICS, INC.
Entity Incorporation, State or Country Code DE
Entity File Number 001-39186
Entity Tax Identification Number 81-2974255
Entity Address, Address Line One 3027 Townsgate Road
Entity Address, Address Line Two Suite300
Entity Address, City or Town Westlake Village
Entity Address, State or Province CA
Entity Address, Postal Zip Code 91361
City Area Code 805
Local Phone Number 418-5006
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, par value $0.0001 per share
Trading Symbol ARQT
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
Amendment Flag false
Entity Central Index Key 0001787306
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