• Arcutis to receive $30 million upfront payment and is eligible to receive potential development and commercial milestone payments, as well as double digit tiered royalties

WESTLAKE VILLAGE, Calif. and HANGZHOU, China, Aug. 10, 2023 (GLOBE NEWSWIRE) — Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, and Hangzhou Zhongmei Huadong Pharmaceutical Co, a wholly owned subsidiary of Huadong Medicine Co., Ltd. (SZ.000963), today announced that the companies have entered into a strategic collaboration and licensing agreement for the development, manufacture, and commercialization of topical roflumilast in Greater China (mainland China, Hong Kong, Macau, and Taiwan) and Southeast Asia (Indonesia, Singapore, The Philippines, Thailand, Myanmar, Brunei, Cambodia, Laos, Malaysia, and Vietnam). Huadong will receive an exclusive license for both the cream and foam formulations of topical roflumilast, a next generation phosphodiesterase type 4 (PDE4) inhibitor, for multiple dermatological conditions including plaque psoriasis, seborrheic dermatitis, and atopic dermatitis, and potentially additional dermatological conditions in the future.

“This collaboration provides Arcutis access to the second largest pharmaceutical market in the world, providing an unparalleled opportunity to help individuals in this region suffering from immune-mediated skin diseases, and provides meaningful non-dilutive capital for us. With Huadong’s deep dermatology and regional expertise, we are confident they are the ideal partner to develop and commercialize topical roflumilast for multiple dermatological indications in the Greater China and Southeast Asia markets,” said Frank Watanabe, President and Chief Executive Officer, Arcutis. “This collaboration provides further validation of topical roflumilast’s potential to be an effective and well-tolerated steroid-free treatment option for millions of people.”

“Arcutis is a leader in medical dermatology with a successful launch of topical roflumilast cream in plaque psoriasis and three additional successful Phase 3 programs completed in seborrheic dermatitis, atopic dermatitis, and scalp and body psoriasis in the United States. We are honored to partner with Arcutis to bring topical roflumilast to the Greater China and Southeast Asia markets and continue to make an impact for those suffering from immune-mediated skin diseases,” said Liang Lu, Chairman and CEO of Huadong Medicine.

Under the terms of the agreement, Arcutis will receive an upfront payment of $30 million, and an additional $64.25 million if certain regulatory and sales milestones are achieved. Arcutis is also eligible to receive tiered double-digit royalties.

Huadong will be responsible for development, manufacturing, and commercialization of roflumilast cream 0.3% and other topical roflumilast presentations in Greater China and Southeast Asia with the oversight of a joint steering committee comprised of individuals from both companies. Arcutis will continue to be responsible for the development and commercialization of ZORYVE in the United States and other geographies. The transaction is effective immediately upon the execution of the Collaboration and License Agreement.

About Topical Roflumilast
Arcutis is developing topical cream and foam formulations of roflumilast, a highly potent and selective PDE4 inhibitor being investigated as a once-daily, nonsteroidal, topical treatment for multiple dermatologic conditions. PDE4 – an established target in dermatology – is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators. Roflumilast foam is a once-daily foam formulation of roflumilast which the Company is developing for both seborrheic dermatitis and scalp and body psoriasis.

Roflumilast cream 0.3% (ZORYVE®) is approved by the Food and Drug Administration (FDA) for the topical treatment of plaque psoriasis in adults and adolescents.

About ZORYVE (roflumilast) Cream 0.3%
ZORYVE (roflumilast) cream 0.3% is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.

IMPORTANT SAFETY INFORMATION
The use of ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).

The most common adverse reactions (≥1%) include diarrhea (3%), headache (2%), insomnia (1%), nausea (1%), application site pain (1%), upper respiratory tract infection (1%), and urinary tract infection (1%).

Please see full Prescribing Information.

About Arcutis
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is an early 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 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 www.arcutis.com or follow Arcutis on LinkedIn, Facebook, and Twitter.

About Huadong Medicine

Huadong Medicine Co., Ltd. (SZ.000963) is a leading Chinese pharmaceutical company based in Hangzhou, China. Founded in 1993, Huadong Medicine has fully integrated R&D, manufacturing, distribution, sales, and marketing capabilities. Huadong Medicine’s product portfolio and pipeline are specialized in oncology, immune-dermatology, nephrology, and diabetes. The company has 14,000 employees and one of the most extensive commercial coverage and marketing capabilities in China. ‘Patient Centered, Science Driven’ is Huadong Medicine’s value. For additional information, please visit www.eastchinapharm.com/en.

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 ZORYVE to simplify disease management for care of plaque psoriasis; the potential of real-world use results of topical roflumilast, as well as the commercial launch of ZORYVE in plaque psoriasis in the United States and other geographies. These statements are subject to 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. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition and other important factors discussed in 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. You should not place undue reliance on any forward-looking statements in this press release. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

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

Investors
Eric McIntyre, Head of Investor Relations
emcintyre@arcutis.com

  • Achieved total revenues of $5.2 million in the second quarter of 2023. Net product revenues for ZORYVE® (roflumilast) cream 0.3% were $4.8 million, a 72% increase compared to the first quarter of 2023, driven by nearly 40% demand growth as well as gross-to-net improvement
  • Continued expansion of commercial payer coverage for ZORYVE in plaque psoriasis with over 130 million commercial lives covered in the United States, including all three of the largest pharmacy benefit managers (PBMs)
  • Launched ZORYVE for plaque psoriasis in Canada in June 2023, with excellent early reception from patients, physicians, and payers
  • Strong financial position with approximately $270 million in cash, cash equivalents, and marketable securities as of June 30, 2023

WESTLAKE VILLAGE, Calif., Aug. 08, 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 June 30, 2023, and provided a business update.

“We continue to execute on our strategy to build the leading innovation-driven dermatology company in the industry. With our world-class formulation expertise, track record of clinical and regulatory success, and robust commercial infrastructure, topical roflumilast represents a truly unique, de-risked asset, with significant operating leverage and multiple catalysts ahead,” said Frank Watanabe, Arcutis’ President and Chief Executive Officer. “The ZORYVE launch in plaque psoriasis is strengthening on all fronts, and notably with our high-quality commercial coverage now reaching a critical mass, we will continue to invest to fuel the next leg of the psoriasis launch, while also preparing for the upcoming launches in seborrheic dermatitis and atopic dermatitis in 2024, upon their respective anticipated U.S. Food and Drug Administration (FDA) approvals.”

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 for the treatment of plaque psoriasis and under development for atopic dermatitis

  • The launch of ZORYVE in plaque psoriasis continued to build momentum in the second quarter, with strong demand growth, commercial formulary access expansion, and gross-to-net improvement. Over 70,000 prescriptions have been filled since launch by over 7,500 unique prescribers, reflecting the high levels of patient and physician satisfaction with the ZORYVE clinical profile. In less than 12 months since launch, the Company has secured high-quality payer coverage for ZORYVE at all three of the largest PBMs in the United States, now totaling more than 130 million commercially-insured lives. This coverage represents roughly 80% of the total commercial lives. Importantly, over 90% of those 130 million covered lives have access to ZORYVE without a prior authorization, aligned with our corporate access goals. The Company anticipates the benefits of this coverage and our efforts to accelerate coverage pull-through will drive further gross-to-net improvement in the second half of 2023.
  • In December 2022, Arcutis submitted a supplemental New Drug Application (sNDA) to the FDA for ZORYVE for an expanded indication for the treatment of plaque psoriasis in children down to 2 years of age. The Company anticipates potential FDA approval in the fourth quarter of 2023.
  • In the fourth quarter of 2022, Arcutis announced positive topline results from INTEGUMENT-1 and INTEGUMENT-2, the two pivotal Phase 3 trials evaluating roflumilast cream 0.15% for the treatment of atopic dermatitis in individuals 6 years of age or older. The Company anticipates submitting an sNDA to the FDA for ages 6 and above late in the third quarter or early in the fourth quarter of 2023.
  • In May 2023, Arcutis announced the completion of enrollment in INTEGUMENT-PED, the third Pivotal Phase 3 trial in atopic dermatitis, in individuals aged 2 to 5 years old. Topline data from INTEGUMENT-PED are expected in the third quarter of 2023. If positive, the Company expects these data to be sufficient basis for an sNDA submission, after the anticipated approval of roflumilast cream in atopic dermatitis for ages 6 and above.

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

  • In April 2023, the FDA accepted Arcutis’ New Drug Application (NDA) submission for the treatment of moderate-to-severe seborrheic dermatitis, assigning a target action date of December 16, 2023.
  • In September 2022, Arcutis announced 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 following the potential approval of roflumilast foam for seborrheic dermatitis.

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.

Recent Corporate Highlights 

  • In July 2023, the United States Patent and Trademark Office awarded the Company a new method of treatment patent that provides relevant patent protection for roflumilast foam in the treatment of seborrheic dermatitis until 2041.
  • In July 2023, Great Place To Work® and Fortune magazine named the Company to the Best Workplaces for Millennials™ list for 2023.
  • In May 2023, Ayisha Jeter was appointed interim Chief Commercial Officer. Ms. Jeter has led Arcutis’ access and reimbursement team since joining the Company in 2020, and brings more than 20 years of broad commercial experience in the pharmaceutical industry, including multiple product launches across therapeutic areas.

Second Quarter 2023 Summary Financial Results

Total revenues for the quarter ended June 30, 2023 were $5.2 million. Net product revenues related to sales of ZORYVE were $4.8 million driven by strong unit demand growth as well as improvements in gross-to-net sales deductions compared to the first quarter of 2023. Other revenues for the quarter ended June 30, 2023 were $0.4 million, related to an equity interest received as part of a previous collaboration agreement.

Cost of sales for the quarter ended June 30, 2023 were $0.8 million.

Research and development (R&D) expenses for the quarter ended June 30, 2023 were $25.2 million compared to $38.2 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 June 30, 2023 were $46.0 million compared to $27.6 million for the corresponding period in 2022. The year-over-year increase was primarily due to higher headcount and sales and marketing expenses related to the launch of ZORYVE.

Net loss was $71.0 million, or $1.16 per basic and diluted share, for the quarter ended June 30, 2023 compared to $67.4 million, or $1.31 per basic and diluted share, for the corresponding period in 2022.

Cash, cash equivalents, restricted cash, and marketable securities were $269.6 million as of June 30, 2023, compared to $410.8 million as of December 31, 2022. Net cash used in operating activities was $66.5 million during the second 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.

About Arcutis

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, including market access and reimbursement; 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 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.

Contacts:

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

Investors
Eric McIntyre, Head of Investor Relations
emcintyre@arcutis.com


ARCUTIS BIOTHERAPEUTICS, INC.
Condensed Consolidated Balance Sheets
(In thousands)

  June 30,   December 31,
    2023       2022  
  (unaudited)    
ASSETS      
Current assets:      
Cash and cash equivalents $ 105,114     $ 53,641  
Restricted cash   925       1,234  
Marketable securities   163,557       355,948  
Trade receivable, net   17,207       8,458  
Inventories   10,474       7,514  
Prepaid expenses and other current assets   11,591       10,611  
Total current assets   308,868       437,406  
Property and equipment, net   1,867       1,881  
Intangible assets, net   6,812       7,188  
Operating lease right-of-use asset   2,546       2,721  
Other assets   596       78  
Total assets $ 320,689     $ 449,274  
LIABILITIES AND STOCKHOLDERS’ EQUITY      
Current liabilities:      
Accounts payable $ 17,156     $ 8,827  
Accrued liabilities   18,808       28,323  
Operating lease liability   695       657  
Total current liabilities   36,659       37,807  
Operating lease liability, noncurrent   3,755       4,117  
Long-term debt, net   199,767       197,769  
Total liabilities   240,181       239,693  
Stockholders’ equity:      
Common stock   6       6  
Additional paid-in capital   951,649       930,425  
Accumulated other comprehensive loss   (292 )     (1,086 )
Accumulated deficit   (870,855 )     (719,764 )
Total stockholders’ equity   80,508       209,581  
Total liabilities and stockholders’ equity $ 320,689     $ 449,274  


ARCUTIS BIOTHERAPEUTICS, INC.
Condensed Consolidated Statements of Operations
(In thousands, except share and per share data)
(unaudited)

  Three Months Ended June 30,   Six Months Ended June 30,
    2023       2022       2023       2022  
Revenues:              
Product revenue, net $ 4,770     $     $ 7,551     $  
Other revenue   420             420        
Total revenues   5,190             7,971        
               
Operating expenses:              
Cost of sales   776             1,559        
Research and development   25,219       38,205       60,564       78,827  
Selling, general, and administrative   45,958       27,622       88,876       49,628  
Total operating expenses   71,953       65,827       150,999       128,455  
Loss from operations   (66,763 )     (65,827 )     (143,028 )     (128,455 )
               
Other income (expense):              
Other income, net   3,121       421       6,328       563  
Interest expense   (7,349 )     (2,000 )     (14,391 )     (3,838 )
Total other income (expense)   (4,228 )     (1,579 )     (8,063 )     (3,275 )
               
Net loss $ (70,991 )   $ (67,406 )   $ (151,091 )   $ (131,730 )
               
Per share information:              
Net loss per share, basic and diluted $ (1.16 )   $ (1.31 )   $ (2.46 )   $ (2.58 )
Weighted-average shares used in computing net loss per share, basic and diluted   61,430,620       51,422,386       61,300,577       50,970,465  

WESTLAKE VILLAGE, Calif., Aug. 04, 2023 (GLOBE NEWSWIRE) — Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported the grant of an aggregate of 38,500 restricted stock units of Arcutis’ common stock to five newly hired employees. These awards were approved by the Compensation Committee of Arcutis’ Board of Directors and granted under the Arcutis Biotherapeutics, Inc. 2022 Inducement Plan, with a grant date of August 1, 2023, as an inducement material to the new employees entering into employment with Arcutis, in accordance with Nasdaq Listing Rule 5635(c)(4).

The restricted stock units vest over four years, with 25 percent vesting on each annual anniversary of the vesting commencement date, subject to the employee being continuously employed by Arcutis as of such vesting dates.

Arcutis is providing this information in accordance with Nasdaq Listing Rule 5635(c)(4).

About Arcutis
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is an early 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 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 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 its potential to address urgent needs and expectations with regard to the timing of data and regulatory events. 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 28, 2023, as well as any subsequent filings with the SEC. You should not place undue reliance on any forward-looking statements in this press release. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

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

Investors
Eric McIntyre, Head of Investor Relations
emcintyre@arcutis.com

WESTLAKE VILLAGE, Calif., July 24, 2023 (GLOBE NEWSWIRE) — Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that it will host a conference call and webcast at 4:30 p.m. ET on Tuesday, August 8, 2023, to report its second quarter financial results.

The schedule for the press release and conference call/webcast is as follows:

  • Q2 2023 Press Release: Tuesday, August 8, 2023, after the close of the U.S. financial markets
  • Q2 2023 Earnings Call: Tuesday, August 8, 2023, at 4:30 p.m. ET

A live webcast of the call and the presentation material will be available on the “Events” section of the Company’s investor website. An archived replay of the webcast will also be available on the Arcutis investor website following the call.

About Arcutis
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is an early 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 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 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 its potential to address urgent needs and expectations with regard to the timing of data and regulatory events. 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 28, 2023, as well as any subsequent filings with the SEC. You should not place undue reliance on any forward-looking statements in this press release. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

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

Investors
Eric McIntyre, Head of Investor Relations
emcintyre@arcutis.com

  • Coverage at CVS Caremark, the largest pharmacy benefit manager (PBM) in the United States was effective July 5
  • All three of the largest pharmacy benefit managers in the United States have now included ZORYVE on formulary, providing access to 80% of commercial lives
  • ZORYVE is a once-daily, steroid-free cream for adults and adolescents with plaque psoriasis, including all affected areas of the body and for long-term use

WESTLAKE VILLAGE, Calif., July 17, 2023 (GLOBE NEWSWIRE) — Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today announced that ZORYVE® (roflumilast) cream 0.3% for the treatment of plaque psoriasis, including intertriginous psoriasis in adults and adolescents, is now covered as a preferred tier product on CVS Caremark’s largest national commercial formularies effective July 5. These national formularies provide access to an additional 20 million commercial lives in the United States.

ZORYVE is covered for individuals with plaque psoriasis and a prior history of use of a topical steroid, although no prior steroid therapy is required for individuals with plaque psoriasis in sensitive skin areas.

“This is the largest U.S. pharmacy benefit manager, and the third to include ZORYVE on its national formularies since we launched less than a year ago. We have now unlocked broad high-quality access for a total of 131 million commercially insured patients, representing 80% of covered lives in the United States. Notably, in line with our access goals, more than 90% of the 130 million covered commercial patients have access to ZORYVE without a prior authorization,” said Frank Watanabe, President and CEO of Arcutis. “The placement of ZORYVE in a preferred tier position aligns with our focus on ensuring affordable access to ZORYVE so that adults and adolescents with plaque psoriasis can benefit from our effective and well-tolerated therapy.”

The vast majority of individuals with plaque psoriasis use topical therapies, and until recently there were few steroid-free options. ZORYVE, a once-daily, steroid-free phosphodiesterase-4 (PDE4) inhibitor cream, provides rapid results for both hard-to-treat areas, such as knees and elbows, as well as sensitive areas, such as the face, intertriginous areas, and genitalia.

In addition to working with payers, the company is committed to providing affordable access to ZORYVE through responsible pricing, ZORYVE Direct, a patient access support and saving program*, and the Arcutis Cares™ patient assistance program, which provides ZORYVE at no cost for financially eligible patients who are uninsured or underinsured.

ZORYVE is available by prescription only. For more information about ZORYVE visit zoryve.com.

About ZORYVE®
ZORYVE (roflumilast) cream 0.3% is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.

IMPORTANT SAFETY INFORMATION
The use of ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).

The most common adverse reactions (≥1%) include diarrhea (3%), headache (2%), insomnia (1%), nausea (1%), application site pain (1%), upper respiratory tract infection (1%), and urinary tract infection (1%).

Please see full Prescribing Information.

About Arcutis
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is an early 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 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 www.arcutis.com or follow Arcutis on LinkedIn, Facebook, and Twitter.

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 ZORYVE to simplify disease management for care of plaque psoriasis; the potential of real-world use results of roflumilast cream, the commercial launch of ZORYVE in plaque psoriasis, and access and continued expansion in commercial coverage with payers. These statements are subject to 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. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition and other important factors discussed in 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. You should not place undue reliance on any forward-looking statements in this press release. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

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

Investors
Eric McIntyre, Head of Investor Relations
emcintyre@arcutis.com

* Uninsured patients and patients with government insurance are not eligible for the ZORYVE Direct savings program; Other terms and restrictions apply

Subject to financial eligibility requirements. Other terms and restrictions apply

WESTLAKE VILLAGE, Calif., July 05, 2023 (GLOBE NEWSWIRE) — Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported the grant of an aggregate of 60,250 restricted stock units of Arcutis’ common stock as well as options to purchase an aggregate of 18,000 shares of Arcutis’ common stock to seven newly hired employees. These awards were approved by the Compensation Committee of Arcutis’ Board of Directors and granted under the Arcutis Biotherapeutics, Inc. 2022 Inducement Plan, with a grant date of July 3, 2023, as an inducement material to the new employees entering into employment with Arcutis, in accordance with Nasdaq Listing Rule 5635(c)(4).

The restricted stock units vest over four years, with 25 percent vesting on each annual anniversary of the vesting commencement date, subject to the employee being continuously employed by Arcutis as of such vesting dates. The stock options vest over four years, with 25 percent vesting on the one-year anniversary of the vesting commencement date for such employee and the remainder vesting in 36 equal monthly installments over the following three years, subject to the employee being continuously employed by Arcutis as of such vesting dates. The stock options have a ten-year term and an exercise price of $8.75 per share, equal to the per share closing price of Arcutis’ common stock as reported by Nasdaq on July 3, 2023.

Arcutis is providing this information in accordance with Nasdaq Listing Rule 5635(c)(4).

About Arcutis
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is an early 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 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 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 its potential to address urgent needs and expectations with regard to the timing of data and regulatory events. 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 28, 2023, as well as any subsequent filings with the SEC. You should not place undue reliance on any forward-looking statements in this press release. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

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

Investors
Eric McIntyre, Head of Investor Relations
emcintyre@arcutis.com

WESTLAKE VILLAGE, Calif., June 06, 2023 (GLOBE NEWSWIRE) — Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early-stage commercial company focused on developing meaningful innovations in immuno-dermatology, today announced that Arcutis management will participate in an upcoming investor conference.

Details for the company’s participation are as follows:

  • Goldman Sachs 44th Annual Global Healthcare Conference
    Fireside Chat Date: Tuesday, June 13, 2023
    Fireside Chat Time: 10:40am PT / 1:40 pm ET

The webcast for this conference may be accessed at the “Events” section of the Company’s website. The replay of the webcast will be available on the Arcutis website for 180 days following the conference.

About Arcutis
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is an early 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 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 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 its potential to address urgent needs and expectations with regard to the timing of data and regulatory events. 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 28, 2023, as well as any subsequent filings with the SEC. You should not place undue reliance on any forward-looking statements in this press release. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Contacts:

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

Investors
Eric McIntyre, Head of Investor Relations
emcintyre@arcutis.com

WESTLAKE VILLAGE, Calif., June 05, 2023 (GLOBE NEWSWIRE) — Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported the grant of an aggregate of 58,250 restricted stock units of Arcutis’ common stock as well as options to purchase an aggregate of 17,000 shares of Arcutis’ common stock to seven newly hired employees. These awards were approved by the Compensation Committee of Arcutis’ Board of Directors and granted under the Arcutis Biotherapeutics, Inc. 2022 Inducement Plan, with a grant date of June 1, 2023, as an inducement material to the new employees entering into employment with Arcutis, in accordance with Nasdaq Listing Rule 5635(c)(4).

The restricted stock units vest over four years, with 25 percent vesting on each annual anniversary of the vesting commencement date, subject to the employee being continuously employed by Arcutis as of such vesting dates. The stock options vest over four years, with 25 percent vesting on the one-year anniversary of the vesting commencement date for such employee and the remainder vesting in 36 equal monthly installments over the following three years, subject to the employee being continuously employed by Arcutis as of such vesting dates. The stock options have a ten-year term and an exercise price of $7.65 per share, equal to the per share closing price of Arcutis’ common stock as reported by Nasdaq on June 1, 2023.

Arcutis is providing this information in accordance with Nasdaq Listing Rule 5635(c)(4).

About Arcutis
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is an early 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 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 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 its potential to address urgent needs and expectations with regard to the timing of data and regulatory events. 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 28, 2023, as well as any subsequent filings with the SEC. You should not place undue reliance on any forward-looking statements in this press release. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

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

Investors
Eric McIntyre, Head of Investor Relations
emcintyre@arcutis.com

  • Senior Vice President and Chief Commercial Officer (CCO) Ken Lock Stepping Down
  • Ayisha Jeter Appointed Interim CCO

WESTLAKE VILLAGE, Calif., May 24, 2023 (GLOBE NEWSWIRE) — Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced a leadership change. Ken Lock, who has served as Senior Vice President and Chief Commercial Officer (CCO) since October 2019, is stepping down to attend to personal matters effective June 2, 2023. During this transition period, Arcutis’ Vice President of Market Access, Ayisha Jeter, has been appointed interim CCO.

Mr. Lock’s contributions to the company have been significant, ranging from leading the overall commercialization process and building out a robust sales, marketing, access, and commercial operations organization, to the launch of the Company’s first product, ZORYVE® (roflumilast) cream 0.3% for individuals with plaque psoriasis 12 years of age and older in both the United States and Canada.

Ms. Jeter has led Arcutis’ access and reimbursement strategy since joining the Company in June 2020. She brings more than 20 years of biopharmaceutical and pharmaceutical industry experience across sales, sales leadership, and market access, including multiple product launches across a variety of therapeutic areas. At Arcutis, Ms. Jeter helped found the Arcutis Culture Team, helping to promote a diverse and inclusive culture.

“On behalf of our Board and team, I would like to thank Ken for his immense contributions to Arcutis and wish him success in his future endeavors. We are grateful for his leadership and dedication as he built our commercial organization, launched ZORYVE in plaque psoriasis, and prepared us for future potential indications of roflumilast including expansion in psoriasis down to 2 years of age and potential approval in seborrheic dermatitis,” said Frank Watanabe, President and Chief Executive Officer of Arcutis. “We are confident in the ability of Ayisha to step into this new role, given the depth and breadth of her sales and market access capability, as well as her strong leadership and operational expertise.”

Arcutis has commenced a search for a permanent CCO.

About Arcutis
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is an early 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 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 www.arcutis.com or follow Arcutis on LinkedIn, Facebook, and Twitter.

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, the commercial launch of ZORYVE in plaque psoriasis, the potential expanded FDA approval of its plaque psoriasis indication down to 2 years or age, as well as potential approval of the Company’s roflumilast foam in seborrheic dermatitis. These statements are subject to 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. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition and other important factors discussed in 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. You should not place undue reliance on any forward-looking statements in this press release. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

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

Investors
Eric McIntyre, Head of Investor Relations
emcintyre@arcutis.com

  • Achieved net revenues of $2.8 million for ZORYVE® (roflumilast) cream 0.3% in the first quarter of 2023, with unit demand growth nearly doubling quarter-over-quarter
  • Continued expansion of commercial payer coverage for ZORYVE in plaque psoriasis with over 110 million commercial lives covered in the United States
  • Received Health Canada approval of ZORYVE for plaque psoriasis, with launch expected in the coming weeks
  • Completed enrollment in INTEGUMENT-PED, the Pivotal Phase 3 trial in individuals with atopic dermatitis aged 2 to 5 years old, with topline data expected in the third quarter of 2023
  • Received U.S. Food and Drug Administration (FDA) acceptance of our New Drug Application (NDA) for roflumilast foam for the treatment of seborrheic dermatitis in adults and adolescents, with a target action date of December 16, 2023
  • Strong financial position with approximately $333 million in cash, cash equivalents, and marketable securities, with capital allocation focused on commercialization

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

  • The launch of ZORYVE continues to build momentum, with prescription growth nearly doubling in the first quarter of 2023, compared to the fourth quarter of 2022. The Company continues to expand high-quality payer coverage for ZORYVE with more than 110 million commercially-insured lives in the United States, with over 90% of those lives devoid of prior authorizations. The Company anticipates continued patient demand growth and further expansion of commercial coverage in 2023, fueling ZORYVE’s potential to meaningfully convert the topical steroid market.
  • In the fourth quarter of 2022, Arcutis announced positive topline results from INTEGUMENT-1 and INTEGUMENT-2, the two pivotal Phase 3 trials evaluating roflumilast cream 0.15% for the treatment of atopic dermatitis in individuals 6 years of age or older. The Company anticipates submitting a supplemental New Drug Application (sNDA) to the FDA for ages 6 and above late in the third quarter or early in the fourth quarter of 2023.
  • In May 2023, Arcutis announced the completion of enrollment in INTEGUMENT-PED, the third Pivotal Phase 3 trial in atopic dermatitis, in individuals aged 2 to 5 years old. Topline data from INTEGUMENT-PED are expected in the third quarter of 2023. If positive, the Company expects these data to be sufficient basis for an sNDA submission, after the anticipated approval of roflumilast cream in atopic dermatitis for ages 6 and above.
  • In December 2022, Arcutis submitted an sNDA to the FDA for ZORYVE for an expanded indication for the treatment of plaque psoriasis in children down to 2 years of age. The Company anticipates potential FDA approval in the fourth quarter of 2023.

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

  • In April 2023, the FDA accepted Arcutis’ NDA submission for the treatment of moderate-to-severe seborrheic dermatitis, assigning a target action date of December 16, 2023.
  • In September 2022, Arcutis announced 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 following the potential approval of roflumilast foam for seborrheic dermatitis.

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 patient in a Phase 1b study in alopecia areata.

ARQ-252 – an alternative topical cream formulation of ivarmacitinib, being developed as a potential treatment for chronic hand eczema, vitiligo, and other inflammatory dermatoses

  • The Company has paused development of ARQ-252 as part of ongoing efforts to prioritize investments in commercialization.

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.

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.

About Arcutis

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.

Contacts:

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

Investors
Eric McIntyre, Head of Investor Relations
emcintyre@arcutis.com

ARCUTIS BIOTHERAPEUTICS, INC.
Condensed Balance Sheets
(In thousands)

  March 31,   December 31,
    2023       2022  
  (unaudited)    
ASSETS      
Current assets:      
Cash and cash equivalents $ 81,405     $ 53,641  
Restricted cash   925       1,234  
Trade receivable, net   12,769       8,458  
Marketable securities   251,000       355,948  
Inventories   8,551       7,514  
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  
Other assets   78       78  
Total assets $ 379,458     $ 449,274  
LIABILITIES AND STOCKHOLDERS’ EQUITY      
Current liabilities:      
Accounts payable $ 12,485     $ 8,827  
Accrued liabilities   23,864       28,323  
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  
Total liabilities   239,726       239,693  
Stockholders’ equity:      
Common stock   6       6  
Additional paid-in capital   940,004       930,425  
Accumulated other comprehensive loss   (414 )     (1,086 )
Accumulated deficit   (799,864 )     (719,764 )
Total stockholders’ equity   139,732       209,581  
Total liabilities and stockholders’ equity $ 379,458     $ 449,274  

ARCUTIS BIOTHERAPEUTICS, INC.

Condensed Statements of Operations
(In thousands, except share and per share data)
(unaudited)

  Three Months Ended March 31,
    2023       2022  
Revenues:      
Product revenue, net $ 2,781     $  
Total revenues   2,781        
       
Operating expenses:      
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  
Interest expense   (7,042 )     (1,838 )
Total other income (expense)   (3,835 )     (1,696 )
       
Net loss $ (80,100 )   $ (64,324 )
       
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  

 

WESTLAKE VILLAGE, Calif., May 05, 2023 (GLOBE NEWSWIRE) — Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported the grant of an aggregate of 84,000 restricted stock units of Arcutis’ common stock as well as options to purchase an aggregate of 15,000 shares of Arcutis’ common stock to nine newly hired employees. These awards were approved by the Compensation Committee of Arcutis’ Board of Directors and granted under the Arcutis Biotherapeutics, Inc. 2022 Inducement Plan, with a grant date of May 1, 2023, as an inducement material to the new employees entering into employment with Arcutis, in accordance with Nasdaq Listing Rule 5635(c)(4).

The restricted stock units vest over four years, with 25 percent vesting on each annual anniversary of the vesting commencement date, subject to the employee being continuously employed by Arcutis as of such vesting dates. The stock options vest over four years, with 25 percent vesting on the one-year anniversary of the vesting commencement date for such employee and the remainder vesting in 36 equal monthly installments over the following three years, subject to the employee being continuously employed by Arcutis as of such vesting dates. The stock options have a ten-year term and an exercise price of $14.39 per share, equal to the per share closing price of Arcutis’ common stock as reported by Nasdaq on May 1, 2023.

Arcutis is providing this information in accordance with Nasdaq Listing Rule 5635(c)(4).

About Arcutis
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is an early 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 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 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 its potential to address urgent needs and expectations with regard to the timing of data and regulatory events. 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 28, 2023, as well as any subsequent filings with the SEC. You should not place undue reliance on any forward-looking statements in this press release. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

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

Investors
Eric McIntyre, Head of Investor Relations
emcintyre@arcutis.com

  • A total of 652 children, ages 2 to 5, were enrolled in the study
  • Topline data expected in the third quarter
  • Atopic dermatitis (AD) affects approximately 26 million adults and children in the United States

WESTLAKE VILLAGE, Calif., May 02, 2023 (GLOBE NEWSWIRE) — Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immune-dermatology, today announced the enrollment of the last subject in the INTEGUMENT-PED Pivotal Phase 3 trial evaluating roflumilast cream 0.05% for the treatment of mild to moderate AD in children ages 2 to 5. Roflumilast cream is a once-daily topical formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4), which the Company is evaluating in two doses for AD: 0.15% for adults and children 6 years of age and older, and 0.05% for children aged 2 to 5 years. Arcutis previously reported positive topline data in similarly designed Pivotal Phase 3 trials of roflumilast cream 0.15% in ages 6 and above.

AD is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United States. Topical therapies are an important treatment option for the majority of individuals who use pharmaceuticals to treat their disease.

“Topical steroids are the first-line of treatment for AD in children, and there are few treatment options available for chronic use. It was critical for Arcutis that we developed and studied the effectiveness and safety of roflumilast cream in children as young as age 2 because of the tremendous burden AD can represent, including lack of sleep and persistent itch,” said Patrick Burnett, MD, PhD, FAAD, Chief Medical Officer at Arcutis. “Roflumilast cream is a once-daily, steroid free treatment that was formulated to be a non-greasy, moisturizing cream that absorbs quickly. In addition, roflumilast cream does not include sensitizing excipients or irritants such as propylene glycol.”

The Company plans to report topline data for the INTEGUMENT-PED trial in the third quarter 2023. If successful, the Company expects these data to be sufficient basis for a separate supplemental new drug application (sNDA) submission after the approval of roflumilast cream 0.15% in AD for ages 6 and above. Arcutis plans to submit the new drug application (NDA) for roflumilast cream 0.15% for adults and children age 6 and older in the second half of 2023.

About INTEGUMENT-PED
The “INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis in PEDiatric patients” (INTEGUMENT-PED) is a Phase 3, parallel group, double blind, vehicle-controlled trial in which roflumilast cream 0.05% or vehicle is applied once-daily for four weeks to children 2 to 5 years of age with mild to moderate AD. A total of 652 individuals have been enrolled in the study. The primary endpoint is Investigator Global Assessment (IGA) Success, defined as a Validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline at Week 4. Multiple secondary endpoints will also be evaluated, including itch as measured by the Worst Itch-Numerical Rating Scale (WI-NRS) as well as the proportion of subjects who attain at least a 75% reduction in the Eczema Area and Severity Index (EASI-75) at Week 4.

About Atopic Dermatitis
AD is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United States. AD is characterized by a defect in the skin barrier, which allows allergens and other irritants to enter the skin, leading to an immune reaction and inflammation. This reaction produces a red, itchy rash, most frequently occurring on the face, arms, and legs. The rash can cover significant areas of the body, in some cases half of the body or more. AD typically begins in early childhood and is chronic. It persists into adolescence and even adulthood in some individuals. The rash causes significant pruritus (itching), which can lead to skin damage caused by scratching or rubbing. Since a large percentage of AD patients are very young children, safety is a particularly important consideration in treatment selection.

About Roflumilast Cream
Roflumilast cream is a next generation topical PDE4 inhibitor. PDE4 – an established target in dermatology – is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators. Roflumilast cream 0.3% (ZORYVE®) is approved by the FDA for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older. Roflumilast cream for AD was evaluated at lower doses: 0.15% for adults and children 6 years of age and older and is being evaluated at 0.05% for children aged 2 to 5 years.

About ZORYVE
ZORYVE (roflumilast) cream 0.3% is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.

IMPORTANT SAFETY INFORMATION
The use of ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).

The most common adverse reactions (≥1%) include diarrhea (3%), headache (2%), insomnia (1%), nausea (1%), application site pain (1%), upper respiratory tract infection (1%), and urinary tract infection (1%).

Please see full Prescribing Information.

About Arcutis
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is an early 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 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 www.arcutis.com or follow Arcutis on LinkedIn, Facebook, and Twitter.

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, among others, statements regarding the potential for roflumilast to be approved for the treatment of adults and children with AD, the potential to use roflumilast cream over a long period of time, or chronically, the potential to use roflumilast cream anywhere on the body, including the face and sensitive areas, timing for anticipated data of INTEGUMENT-PED, the potential sNDA filing and the potential for roflumilast to advance the standard of care in AD and other inflammatory dermatologic conditions. These statements are subject to 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. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition and other important factors discussed in 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. You should not place undue reliance on any forward-looking statements in this press release. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

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

Investors
Eric McIntyre, Head of Investor Relations
emcintyre@arcutis.com

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