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Letter Text
Arcutis Biotherapeutics, Inc.
CIK: 0001787306  ·  File(s): 001-39186  ·  Started: 2025-12-02  ·  Last active: 2025-12-02
Awaiting Response 0 company response(s) High
UL SEC wrote to company 2025-12-02
Arcutis Biotherapeutics, Inc.
Financial Reporting Regulatory Compliance
File Nos in letter: 001-39186
Arcutis Biotherapeutics, Inc.
CIK: 0001787306  ·  File(s): 001-39186  ·  Started: 2025-09-15  ·  Last active: 2025-10-10
Response Received 4 company response(s) High - file number match
CR Company responded 2020-01-28
Arcutis Biotherapeutics, Inc.
Offering / Registration Process
File Nos in letter: 001-39186, 333-235806
↓
CR Company responded 2021-04-23
Arcutis Biotherapeutics, Inc.
Financial Reporting Regulatory Compliance Business Model Clarity
File Nos in letter: 001-39186
References: April 13, 2021
↓
CR Company responded 2023-09-15
Arcutis Biotherapeutics, Inc.
Internal Controls Financial Reporting Regulatory Compliance
File Nos in letter: 001-39186
References: September 8, 2023
↓
UL SEC wrote to company 2025-09-15
Arcutis Biotherapeutics, Inc.
Revenue Recognition Financial Reporting Regulatory Compliance
File Nos in letter: 001-39186
↓
CR Company responded 2025-10-10
Arcutis Biotherapeutics, Inc.
File Nos in letter: 001-39186
References: September 15, 2025
Arcutis Biotherapeutics, Inc.
CIK: 0001787306  ·  File(s): 333-276794  ·  Started: 2024-02-05  ·  Last active: 2024-02-06
Response Received 1 company response(s) High - file number match
UL SEC wrote to company 2024-02-05
Arcutis Biotherapeutics, Inc.
Regulatory Compliance Financial Reporting Business Model Clarity
File Nos in letter: 333-276794
↓
CR Company responded 2024-02-06
Arcutis Biotherapeutics, Inc.
File Nos in letter: 333-276794
Arcutis Biotherapeutics, Inc.
CIK: 0001787306  ·  File(s): 005-91349  ·  Started: 2024-01-23  ·  Last active: 2024-01-24
Response Received 1 company response(s) Medium - date proximity
UL SEC wrote to company 2024-01-23
Arcutis Biotherapeutics, Inc.
Filing - SEC Comment Letter to Arcutis Biotherapeutics, Inc.
UPLOAD · 2024-01-23
Generating summary...
↓
CR Company responded 2024-01-24
Arcutis Biotherapeutics, Inc.
References: January 23, 2024
Filing - Correspondence from Arcutis Biotherapeutics, Inc.
CORRESP · 2024-01-24
Generating summary...
Arcutis Biotherapeutics, Inc.
CIK: 0001787306  ·  File(s): N/A  ·  Started: 2023-09-18  ·  Last active: 2023-09-18
Awaiting Response 0 company response(s) Medium
UL SEC wrote to company 2023-09-18
Arcutis Biotherapeutics, Inc.
Filing - SEC Comment Letter to Arcutis Biotherapeutics, Inc.
UPLOAD · 2023-09-18
Generating summary...
Arcutis Biotherapeutics, Inc.
CIK: 0001787306  ·  File(s): N/A  ·  Started: 2023-09-08  ·  Last active: 2023-09-08
Awaiting Response 0 company response(s) Medium
UL SEC wrote to company 2023-09-08
Arcutis Biotherapeutics, Inc.
Filing - SEC Comment Letter to Arcutis Biotherapeutics, Inc.
UPLOAD · 2023-09-08
Generating summary...
Arcutis Biotherapeutics, Inc.
CIK: 0001787306  ·  File(s): N/A  ·  Started: 2021-05-04  ·  Last active: 2021-05-04
Awaiting Response 0 company response(s) Medium
UL SEC wrote to company 2021-05-04
Arcutis Biotherapeutics, Inc.
Filing - SEC Comment Letter to Arcutis Biotherapeutics, Inc.
UPLOAD · 2021-05-04
Generating summary...
Arcutis Biotherapeutics, Inc.
CIK: 0001787306  ·  File(s): N/A  ·  Started: 2021-04-13  ·  Last active: 2021-04-13
Awaiting Response 0 company response(s) Medium
UL SEC wrote to company 2021-04-13
Arcutis Biotherapeutics, Inc.
Filing - SEC Comment Letter to Arcutis Biotherapeutics, Inc.
UPLOAD · 2021-04-13
Generating summary...
Arcutis Biotherapeutics, Inc.
CIK: 0001787306  ·  File(s): 333-249124  ·  Started: 2020-09-29  ·  Last active: 2020-09-29
Orphan - no UPLOAD in window 1 company response(s) Low - unmatched response
CR Company responded 2020-09-29
Arcutis Biotherapeutics, Inc.
File Nos in letter: 333-249124
Filing - Correspondence from Arcutis Biotherapeutics, Inc.
CORRESP · 2020-09-29
Generating summary...
Arcutis Biotherapeutics, Inc.
CIK: 0001787306  ·  File(s): 333-249124  ·  Started: 2020-09-29  ·  Last active: 2020-09-29
Orphan - no UPLOAD in window 1 company response(s) Low - unmatched response
CR Company responded 2020-09-29
Arcutis Biotherapeutics, Inc.
File Nos in letter: 333-249124
Filing - Correspondence from Arcutis Biotherapeutics, Inc.
CORRESP · 2020-09-29
Generating summary...
Arcutis Biotherapeutics, Inc.
CIK: 0001787306  ·  File(s): N/A  ·  Started: 2020-07-27  ·  Last active: 2020-07-27
Awaiting Response 0 company response(s) Medium
UL SEC wrote to company 2020-07-27
Arcutis Biotherapeutics, Inc.
Filing - SEC Comment Letter to Arcutis Biotherapeutics, Inc.
UPLOAD · 2020-07-27
Generating summary...
Arcutis Biotherapeutics, Inc.
CIK: 0001787306  ·  File(s): 333-235806  ·  Started: 2020-01-28  ·  Last active: 2020-01-28
Orphan - no UPLOAD in window 1 company response(s) Low - unmatched response
CR Company responded 2020-01-28
Arcutis Biotherapeutics, Inc.
File Nos in letter: 333-235806
Filing - Correspondence from Arcutis Biotherapeutics, Inc.
CORRESP · 2020-01-28
Generating summary...
Arcutis Biotherapeutics, Inc.
CIK: 0001787306  ·  File(s): 333-235806  ·  Started: 2020-01-13  ·  Last active: 2020-01-13
Orphan - no UPLOAD in window 1 company response(s) Low - unmatched response
CR Company responded 2020-01-13
Arcutis Biotherapeutics, Inc.
File Nos in letter: 333-235806
References: October 4, 2019
Filing - Correspondence from Arcutis Biotherapeutics, Inc.
CORRESP · 2020-01-13
Generating summary...
Arcutis Biotherapeutics, Inc.
CIK: 0001787306  ·  File(s): N/A  ·  Started: 2019-10-31  ·  Last active: 2019-10-31
Awaiting Response 0 company response(s) Medium
UL SEC wrote to company 2019-10-31
Arcutis Biotherapeutics, Inc.
Filing - SEC Comment Letter to Arcutis Biotherapeutics, Inc.
UPLOAD · 2019-10-31
Generating summary...
Arcutis Biotherapeutics, Inc.
CIK: 0001787306  ·  File(s): N/A  ·  Started: 2019-10-07  ·  Last active: 2019-10-07
Awaiting Response 0 company response(s) Medium
UL SEC wrote to company 2019-10-07
Arcutis Biotherapeutics, Inc.
Filing - SEC Comment Letter to Arcutis Biotherapeutics, Inc.
UPLOAD · 2019-10-07
Generating summary...
DateTypeCompanyLocationFile NoLink
2025-12-02 SEC Comment Letter Arcutis Biotherapeutics, Inc. DE 001-39186
Financial Reporting Regulatory Compliance
Read Filing View
2025-10-10 Company Response Arcutis Biotherapeutics, Inc. DE N/A Read Filing View
2025-09-15 SEC Comment Letter Arcutis Biotherapeutics, Inc. DE 001-39186
Revenue Recognition Financial Reporting Regulatory Compliance
Read Filing View
2024-02-06 Company Response Arcutis Biotherapeutics, Inc. DE N/A Read Filing View
2024-02-05 SEC Comment Letter Arcutis Biotherapeutics, Inc. DE 333-276794
Regulatory Compliance Financial Reporting Business Model Clarity
Read Filing View
2024-01-24 Company Response Arcutis Biotherapeutics, Inc. DE N/A Read Filing View
2024-01-23 SEC Comment Letter Arcutis Biotherapeutics, Inc. DE 005-91349 Read Filing View
2023-09-18 SEC Comment Letter Arcutis Biotherapeutics, Inc. DE N/A Read Filing View
2023-09-15 Company Response Arcutis Biotherapeutics, Inc. DE N/A
Internal Controls Financial Reporting Regulatory Compliance
Read Filing View
2023-09-08 SEC Comment Letter Arcutis Biotherapeutics, Inc. DE N/A Read Filing View
2021-05-04 SEC Comment Letter Arcutis Biotherapeutics, Inc. DE N/A Read Filing View
2021-04-23 Company Response Arcutis Biotherapeutics, Inc. DE N/A
Financial Reporting Regulatory Compliance Business Model Clarity
Read Filing View
2021-04-13 SEC Comment Letter Arcutis Biotherapeutics, Inc. DE N/A Read Filing View
2020-09-29 Company Response Arcutis Biotherapeutics, Inc. DE N/A Read Filing View
2020-09-29 Company Response Arcutis Biotherapeutics, Inc. DE N/A Read Filing View
2020-07-27 SEC Comment Letter Arcutis Biotherapeutics, Inc. DE N/A Read Filing View
2020-01-28 Company Response Arcutis Biotherapeutics, Inc. DE N/A
Offering / Registration Process
Read Filing View
2020-01-28 Company Response Arcutis Biotherapeutics, Inc. DE N/A Read Filing View
2020-01-13 Company Response Arcutis Biotherapeutics, Inc. DE N/A Read Filing View
2019-10-31 SEC Comment Letter Arcutis Biotherapeutics, Inc. DE N/A Read Filing View
2019-10-07 SEC Comment Letter Arcutis Biotherapeutics, Inc. DE N/A Read Filing View
DateTypeCompanyLocationFile NoLink
2025-12-02 SEC Comment Letter Arcutis Biotherapeutics, Inc. DE 001-39186
Financial Reporting Regulatory Compliance
Read Filing View
2025-09-15 SEC Comment Letter Arcutis Biotherapeutics, Inc. DE 001-39186
Revenue Recognition Financial Reporting Regulatory Compliance
Read Filing View
2024-02-05 SEC Comment Letter Arcutis Biotherapeutics, Inc. DE 333-276794
Regulatory Compliance Financial Reporting Business Model Clarity
Read Filing View
2024-01-23 SEC Comment Letter Arcutis Biotherapeutics, Inc. DE 005-91349 Read Filing View
2023-09-18 SEC Comment Letter Arcutis Biotherapeutics, Inc. DE N/A Read Filing View
2023-09-08 SEC Comment Letter Arcutis Biotherapeutics, Inc. DE N/A Read Filing View
2021-05-04 SEC Comment Letter Arcutis Biotherapeutics, Inc. DE N/A Read Filing View
2021-04-13 SEC Comment Letter Arcutis Biotherapeutics, Inc. DE N/A Read Filing View
2020-07-27 SEC Comment Letter Arcutis Biotherapeutics, Inc. DE N/A Read Filing View
2019-10-31 SEC Comment Letter Arcutis Biotherapeutics, Inc. DE N/A Read Filing View
2019-10-07 SEC Comment Letter Arcutis Biotherapeutics, Inc. DE N/A Read Filing View
DateTypeCompanyLocationFile NoLink
2025-10-10 Company Response Arcutis Biotherapeutics, Inc. DE N/A Read Filing View
2024-02-06 Company Response Arcutis Biotherapeutics, Inc. DE N/A Read Filing View
2024-01-24 Company Response Arcutis Biotherapeutics, Inc. DE N/A Read Filing View
2023-09-15 Company Response Arcutis Biotherapeutics, Inc. DE N/A
Internal Controls Financial Reporting Regulatory Compliance
Read Filing View
2021-04-23 Company Response Arcutis Biotherapeutics, Inc. DE N/A
Financial Reporting Regulatory Compliance Business Model Clarity
Read Filing View
2020-09-29 Company Response Arcutis Biotherapeutics, Inc. DE N/A Read Filing View
2020-09-29 Company Response Arcutis Biotherapeutics, Inc. DE N/A Read Filing View
2020-01-28 Company Response Arcutis Biotherapeutics, Inc. DE N/A
Offering / Registration Process
Read Filing View
2020-01-28 Company Response Arcutis Biotherapeutics, Inc. DE N/A Read Filing View
2020-01-13 Company Response Arcutis Biotherapeutics, Inc. DE N/A Read Filing View
2025-12-02 - UPLOAD - Arcutis Biotherapeutics, Inc. File: 001-39186
December 2, 2025
Latha Vairavan
Chief Financial Officer
Arcutis Biotherapeutics, Inc.
3027 Townsgate Road Suite 300
Westlake Village, California 91361
Re:Arcutis Biotherapeutics, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2024
Filed February 25, 2025
File No. 001-39186
Dear Latha Vairavan:
            We have completed our review of your filing. We remind you that the company and
its management are responsible for the accuracy and adequacy of their disclosures,
notwithstanding any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2025-10-10 - CORRESP - Arcutis Biotherapeutics, Inc.
Read Filing Source Filing Referenced dates: September 15, 2025
CORRESP
1
filename1.htm

CORRESP

 Arcutis Biotherapeutics, Inc.

3027 Townsgate Road, Suite 300

Westlake Village, CA 91361

October 10, 2025

 CONFIDENTIAL AND PROPRIETARY

DELIVERY VIA SECURE FILE TRANSFER

 U.S.
Securities & Exchange Commission

 100 F Street, N.E.

Washington, D.C. 20549

 Division of Corporation Finance

Attention: Bonnie Baynes & Angela Connell

Re:
 Arcutis Biotherapeutics, Inc.

Annual Report on Form 10-K for the Fiscal Year Ended December 31, 2024

Filed February 25, 2025

File No. 001-39186

To the addressees set forth above:

 This letter
sets forth the response of Arcutis Biotherapeutics, Inc. (the “Company,” “we,” “our” and “us”) to the comments provided by the staff (the
“Staff”) of the Division of Corporation Finance of the Securities and Exchange Commission (the “Commission”) in its letter dated September 15, 2025 (the “Comment
Letter”) with respect to the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 filed with the Commission on February 25, 2025 (the “10-K”).

 For your convenience, we have reproduced the Staff’s comments exactly as
set forth in the Comment Letter in bold below, and set forth below each such comment is the Company’s response. Page numbers and captions referenced in the responses refer to the 10-K unless otherwise
stated. Capitalized terms used but not otherwise defined herein have the meanings ascribed to such terms in the 10-K. We have enclosed with this response a FOIA Confidential Treatment Letter.

* * * * * * * * * *

[***] Certain confidential information contained in this document, marked by bracketed asterisks, has been omitted and filed separately with the SEC
pursuant to 17 C.F.R. § 200.83

 Confidential Treatment Requested by Arcutis Biotherapeutics, Inc.

 Annual Report on Form 10-K filed February 25, 2025

 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations; Results of Operations –
Product Revenue, Net, page 103

1.
 We note your disclosure on page 103 that the $55.9 million, or over 100% increase to ZORYVE cream 0.3%
net product revenue at December 31, 2024 was primarily due to higher end customer demand and improving gross-to-net discounts for ZORYVE cream 0.3%. We also note
your disclosures in the financial statements that you recorded accrued sales deductions of $38.4 million & $11.6 million at December 31, 2024 and December 31, 2023. Given the significant increase in product revenues and
the existence of chargebacks, rebates, returns, prompt pay discounts, and other deductions, please provide the following with a view toward future disclosure:

•

 Given your product sales in Canada since 2023, quantify for us how much of product sales are non-U.S. for all periods and if you expect the future trend to change.

•

 Provide us a roll forward of the accrual for each estimate for the year ended December 31, 2024 showing
the following:

•

 Beginning balance,

•

 Current provision related to sales made in current period,

•

 Current provision related to sales made in prior periods,

•

 Actual returns or credits in current period related to sales made in current period,

•

 Actual returns or credits in current period related to sales made in prior periods, and

•

 Ending balance.

•

 Separately tell us:

•

 The effect that could result from using other reasonably likely assumptions than what you used to arrive at
each accrual such as a range of reasonably likely amounts or other type of sensitivity analysis.

•

 Please provide us a discussion of the amount of and reason for fluctuations for each type of reduction of
gross revenue (i.e. product returns, chargebacks, customer rebates and other discounts and allowances) including the effect that changes in your estimates of these items had on your revenues and operations.

Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that product revenue, net outside the
United States represented less than 10% of the Company’s consolidated product revenue, net for the years ended December 31, 2023 and 2024. The Company currently expects this to continue and, based on the relatively small amount of non-U.S. product revenue, net that it generates, does not believe that supplemental

 [***] Certain
confidential information contained in this document, marked by bracketed asterisks, has been omitted and filed separately with the SEC pursuant to 17 C.F.R. § 200.83

Confidential Treatment Requested by Arcutis Biotherapeutics, Inc.

- 2 -

quantitative disclosure of such non-U.S. product revenue, net is required or would enhance an investor’s understanding of the Company’s
financial condition or results of operations. The Company respectfully advises the Staff that the Company will continue to monitor the extent of its non-U.S. product revenue, net, and if such information
becomes meaningful and material to an investor’s understanding of the Company’s overall business and its financial condition and results of operations, the Company will consider additional disclosure regarding such non-U.S. product revenue, net in future filings.

 As disclosed in the Company’s 10-K for the year ended December 31, 2024, the Company records revenue from product sales at the net sales price, which includes estimates of variable consideration that result from invoice discounts for prompt
payment and distribution service fees, government and private payer rebates, chargebacks, discounts and fees, product returns and costs of co-pay assistance programs for patients, as well as other incentives.
Reserves are established for the estimates of variable consideration based on the amounts earned or to be claimed on the related sales, and the Company records accrued sales deductions related to such considerations based on data received from its
customers, current contractual arrangements, market events and trends, external historical data, and forecasted customer buying patterns and patient utilization. The table below presents information regarding the Company’s total accrued sales
deductions for the year ended December 31, 2024 (in thousands):

Total Accrued Sales
Deductions

 Balance, January 1, 2024

$
11,578

 Amounts charged against product revenues

[***]

 Payments and credits

[***]

 Balance, December 31, 2024

$
38,430

 With respect to the Staff’s comment regarding returns and credits, the Company respectfully advises the
Staff that it recorded returns and related return credits of $0.7 million for the year ended December 31, 2024. As disclosed in the Company’s 10-K for the year ended December 31, 2024, the
Company commenced commercialization of ZORYVE in August 2022 and, in the early product launch period, the Company estimated its provision for returns based on industry data to estimate its provision for returns for the years ended December 31,
2022 and 2023. As the Company continued to commercialize ZORYVE, it collected additional data regarding actual product-specific returns. In the fourth quarter of 2024, with the benefit of two years of commercialization experience and data, the
Company determined to utilize such product-specific information to estimate its provision for returns for the year ended December 31, 2024. This revision to the input used to estimate its returns resulted in a lower estimated returns rate. As a
result of this lower estimated return rate, the Company

 [***] Certain
confidential information contained in this document, marked by bracketed asterisks, has been omitted and filed separately with the SEC pursuant to 17 C.F.R. § 200.83

Confidential Treatment Requested by Arcutis Biotherapeutics, Inc.

- 3 -

recorded a $4.1 million reduction in the Company’s accrued sales deductions as of December 31, 2024 and a favorable true-up impact to
product revenue, net in the fourth quarter of 2024. The amount of the favorable true-up related to sales made in the years ended December 31, 2023 and 2022 was $2.0 million in aggregate, which we
consider to be immaterial for separate disclosure.

 The Company respectfully advises the Staff that it does not consider the change in the
return rate or resulting reduction in accrued sales deductions or favorable true-up impact to product revenue, net, to be significant to the Company’s financial condition or results of operations or
material to an investor’s understanding of the Company’s overall business and its financial condition and results of operations. The Company further advises the Staff that the Company has not made, and does not anticipate making, any
significant changes to the methodologies used to measure provisions for variable consideration. However, the Company notes that the balances within these reserves can fluctuate significantly through the consistent application of the Company’s
methodologies, in part due to the Company’s rapid commercialization and growth. For the year ended December 31, 2024, no material adjustments were recorded due to changes in estimates for amounts related to product revenue from previous
years. The Company advises the Staff that a change of 5% would have an effect on our consolidated total accrual balance of approximately $1.9 million. Further, the Company notes that the increase in total accrued sales deductions as of
December 31, 2024, as compared to December 31, 2023, was primarily driven by higher gross product revenue due to increased product sales and demand, as well as improved coverage.

Finally, the Company respectfully advises the Staff that it believes its existing presentation of product revenue, net and accrued sales
deductions in its disclosures and financial statements, including qualitative disclosure regarding the estimates of variable considerations and developments in
gross-to-net discounts, is currently appropriate for the Company’s stage of commercialization and operations, and its limited number of products available for sale
(ZORYVE cream and foam formulations), and presents information that is material to an investor’s understanding of the Company’s overall business and its financial condition and results of operations.

Note 8. Commitments and Contingencies, page F-24

2.
 We note your disclosure in Item 3 on page 96 of the patent infringement complaints filed against you by Teva
Pharmaceutical Industries Ltd. on August 13, 2024 and September 20, 2024 with the European Patent Office. We also note that you did not include disclosure of your estimate of potential exposure to loss contingencies in Note 8, Commitments
and Contingencies, on page F-24. Please tell us how you applied ASC 450-20-25 in assessing the likelihood of the loss or
impairment of an asset or the incurrence of a liability as a result of the litigation, and your consideration of providing the disclosures required by ASC 450-20-50-3 through 50-5 as it relates to this potential loss contingency, including the amount or range of reasonably possible losses in excess of recorded
amounts.

 [***] Certain
confidential information contained in this document, marked by bracketed asterisks, has been omitted and filed separately with the SEC pursuant to 17 C.F.R. § 200.83

Confidential Treatment Requested by Arcutis Biotherapeutics, Inc.

- 4 -

 Response: The Company respectfully acknowledges the Staff’s comment and advises
the Staff that it evaluates the status of all of its legal proceedings in each reporting period, including the patent infringement complaint filed against the Company by Teva Pharmaceutical Industries (“Teva Complaint”), to assess
whether accruals are appropriate under ASC 450-20-25-2 and to determine whether an estimate of possible loss or a range of
possible losses can be made under ASC 450-20-50.

 During
this evaluation, the Company’s management considers all existing and new matters, including, but not limited to, (i) the nature and status of each matter; (ii) the advice of legal counsel and other advisors related to each matter;
(iii) the Company’s experience or that of other entities in similar matters; (iv) the Company’s belief in whether it has meritorious and valid substantive defenses against the allegations made by the parties; (v) the
damages or awards sought, and associated impact on the business; (vi) substantive rulings by a court on similar matters; (vii) information gleaned through settlement discussions, if any; (viii) whether there is uncertainty as to the
outcome of pending appeals or motions; (ix) whether there are significant factual issues to be resolved; and (x) whether the matters involve novel issues or unsettled legal theories.

Under ASC 450, loss contingency accruals are recognized for probable and estimable losses. In accordance with ASC 450-20-25-2, at the time of the filing of the 10-K, the Company evaluated potential loss
contingencies as discussed above, and specifically reviewed the facts surrounding the Teva Complaint, and determined that a loss resulting from the Teva Complaint was not reasonably possible, as defined in ASC 450-20-20. For example, the patents subject to the Teva Complaint are European patents for which there are no long-lived assets or historical product revenue, net, and the Company respectfully submits that
the outcome of such complaint would not have a material impact on the Company’s current business. The Company also respectfully notes that it believes it has meritorious and valid substantive defenses against the allegations made in the Teva
Complaint. Accordingly, as of December 31, 2024, the Company did not accrue any amount related to loss contingencies under ASC 450 and the Company respectfully submits that disclosure per ASC 450-20-50-3 through 50-5 is not necessary.

Notwithstanding the foregoing paragraph, the Company determined to include a brief summary of the Teva Complaint in Item 3 and in the risk
factors set forth in Item 1A of the 10-K in order to provide investors with an understanding of the current status of this matter. The Company respectfully submits to the Staff that it will clarify its
consideration of ASC 450 in future filings by including the following language, or something similar thereto, in the Commitments and Contingencies note to the financial statements:

 [***] Certain
confidential information contained in this document, marked by bracketed asterisks, has been omitted and filed separately with the SEC pursuant to 17 C.F.R. § 200.83

Confidential Treatment Requested by Arcutis Biotherapeutics, Inc.

- 5 -

 Contingencies

From time to time, the Company may be involved in legal proceedings, as well as demands, claims and threatened litigation, which arise in the
normal course of business or otherwise. The ultimate outcome of any litigation is uncertain and unfavorable outcomes could have a negative impact on the results of operations and financial condition. Regardless of outcome, litigation can have an
adverse impact on the Company because of the defense costs, diversion of management resources and other factors.

 As of December 31,
2024 and 2023, the Company determined that no loss contingencies from legal proceedings, including the patent infringement complaint filed against the Company by Teva Pharmaceutical Industries, met the threshold of reasonably possible as defined in
ASC 450, and accordingly, no material amounts were accrued related to loss contingencies under ASC 450.

* * * * * * * * * *

Please direct any questions or comments regarding this correspondence to our counsel, Ross McAloon of Latham & Watkins LLP, at (714) 755-8051.

Very truly yours,

Arcutis Biotherapeutics, Inc.

By:

 /s/ Latha Vairavan

Name:

Latha Vairavan

Title:

Chief Financial Officer

cc:
 Masaru Matsuda, Arcutis Biotherapeutics, Inc.

Ross McAloon, Latham & Watkins LLP

FOIA Office, Attn: FOIA/Privacy Act Branch Chief,

United States Securities and Exchange Commission (without enclosures)

 [***] Certain
confidential information contained in this document, marked by bracketed asterisks, has been omitted and filed separat
2025-09-15 - UPLOAD - Arcutis Biotherapeutics, Inc. File: 001-39186
September 15, 2025
Latha Vairavan
Chief Financial Officer
Arcutis Biotherapeutics, Inc.
3027 Townsgate Road Suite 300
Westlake Village, California 91361
Re:Arcutis Biotherapeutics, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2024
Filed February 25, 2025
File No. 001-39186
Dear Latha Vairavan:
            We have limited our review of your filing to the financial statements and related
disclosures and have the following comments.
            Please respond to this letter within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe a
comment applies to your facts and circumstances, please tell us why in your response.
            After reviewing your response to this letter, we may have additional comments.
Form 10-K for the Fiscal Year Ended December 31, 2024
Item 7. Management's Discussion and Analysis of Financial Condition and Results of
Operations
Results of Operations - Product Revenue, Net, page 103
We note your disclosure on page 103 that the $55.9 million, or over 100%, increase to
ZORYVE cream 0.3% net product revenue at December 31, 2024 was primarily due
to higher end customer demand and improving gross-to-net discounts for ZORYVE
cream 0.3%.  We also note your disclosures in the financial statements that
you recorded accrued sales deductions of $38.4 million & $11.6 million at December
31, 2024 and December 31, 2023. Given the significant increase in product revenues
and the existence of chargebacks, rebates, returns, prompt pay discounts, and other
deductions, please provide the following with a view toward future disclosure:
•Given your product sales in Canada since 2023, quantify for us how much of
product sales are non-U.S for all periods and if you expect the future trend to
change.1.

September 15, 2025
Page 2
•Provide us a roll forward of the accrual for each estimate for the year ended
December 31, 2024 showing the following:
oBeginning balance,
oCurrent provision related to sales made in current period,
oCurrent provision related to sales made in prior periods,
oActual returns or credits in current period related to sales made in current
period,
oActual returns or credits in current period related to sales made in prior
periods, and
oEnding balance.
•Separately tell us:
oThe effect that could result from using other reasonably likely assumptions
than what you used to arrive at each accrual such as a range of reasonably
likely amounts or other type of sensitivity analysis.
oPlease provide us a discussion of the amount of and reason for fluctuations
for each type of reduction of gross revenue (i.e. product returns, chargebacks,
customer rebates and other discounts and allowances) including the effect
that changes in your estimates of these items had on your revenues and
operations.
Note 8. Commitments and Contingencies, page F-24
2.We note your disclosure in Item 3 on page 96 of the patent infringement complaints
filed against you by Teva Pharmaceutical Industries Ltd. on August 13, 2024 and
September 20, 2024 with the European Patent Office.  We also note that you did not
include disclosure of your estimate of potential exposure to loss contingencies in Note
8, Commitments and Contingencies, on page F-24. Please tell us how you applied
ASC 450-20-25 in assessing the likelihood of the loss or impairment of an asset or the
incurrence of a liability as a result of the litigation, and your consideration of
providing the disclosures required by ASC 450-20-50-3 through 50-5 as it relates to
this potential loss contingency, including the amount or range of reasonably possible
losses in excess of recorded amounts.
            In closing, we remind you that the company and its management are responsible for
the accuracy and adequacy of their disclosures, notwithstanding any review, comments,
action or absence of action by the staff.
            Please contact Bonnie Baynes at 202-551-4924 or Angela Connell at 202-551-3426
with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2024-02-06 - CORRESP - Arcutis Biotherapeutics, Inc.
CORRESP
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Arcutis Biotherapeutics, Inc.

3027 Townsgate Road, Suite 300

Westlake Village, California 91361

February 6, 2024

VIA EDGAR AND E-MAIL

United States Securities and Exchange Commission

Division of Corporation Finance

Office of Life Sciences

100 F Street, N.E.

Washington, D.C. 20549-6010

Attention: Alan Campbell

Re:         Arcutis Biotherapeutics, Inc. Registration Statement on Form S-3 (Registration No. 333-276794)

To the addressee set forth above:

In accordance with Rule 461 under the Securities Act of 1933, as amended, we hereby request acceleration of the effective date of the Registration Statement on Form S-3 (Registration No. 333-276794) (the “Registration Statement”) of Arcutis Biotherapeutics, Inc.  We respectfully request that the Registration Statement become effective as of 4:00 p.m., Washington, D.C. time, on February 8, 2024, or as soon as practicable thereafter, or at such other time thereafter as our counsel, Latham & Watkins LLP, may request by telephone.  Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Latham & Watkins LLP, by calling Ross McAloon at (714) 755-8051.

Thank you for your assistance in this matter.

Sincerely,

ARCUTIS BIOTHERAPEUTICS, INC.

By:

 /s/ Masaru Matsuda

 Masaru Matsuda

 General Counsel

cc:          Frank Watanabe, Arcutis Biotherapeutics, Inc.

John Smither, Arcutis Biotherapeutics, Inc.

Shayne Kennedy, Latham & Watkins LLP

Ross McAloon, Latham & Watkins LLP
2024-02-05 - UPLOAD - Arcutis Biotherapeutics, Inc. File: 333-276794
United States securities and exchange commission logo
February 5, 2024
Todd Franklin Watanabe
President and Chief Executive Officer
Arcutis Biotherapeutics, Inc.
3027 Townsgate Road, Suite 300
Westlake Village, California 91361
Re:Arcutis Biotherapeutics, Inc.
Registration Statement on Form S-3
Filed January 31, 2024
File No. 333-276794
Dear Todd Franklin Watanabe:
            This is to advise you that we have not reviewed and will not review your registration
statement.
            Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
            Please contact Alan Campbell at 202-551-4224 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Ross McAloon
2024-01-24 - CORRESP - Arcutis Biotherapeutics, Inc.
Read Filing Source Filing Referenced dates: January 23, 2024
CORRESP
1
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  650 Town Center Drive, 20th Floor

  Costa Mesa, California  92626-1925

  Tel: +1.714.540.1235  Fax: +1.714.755.8290

  www.lw.com

 FIRM / AFFILIATE OFFICES

Austin Milan

Beijing Munich

Boston New York

Brussels Orange County

Century City Paris

Chicago Riyadh

Dubai San Diego

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  Houston Tel Aviv

  London Tokyo

  Los Angeles Washington, D.C.

  Madrid

January 24, 2024

VIA EDGAR

U.S. Securities and Exchange Commission

Division of Corporation Finance

Office of Mergers and Acquisitions

100 F Street, N.E.

Washington, D.C. 20549

Attention:          David Plattner

Re:        Arcutis Biotherapeutics, Inc.

Schedule TO-I filed on January 16, 2024

File No. 005-91349

To the addressee set forth above:

On behalf of Arcutis Biotherapeutics, Inc., a Delaware corporation (the “Company”), we are transmitting this letter in response to comments received from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) contained in its letter dated January 23, 2024, relating to the Company’s above referenced Tender Offer Statement on Schedule TO filed with the Commission on January 16, 2024 (the “Tender Offer Statement”). This letter is being submitted together with an amendment (“Amendment No. 1”) to the Tender Offer Statement, which has been revised to address the Staff’s comments. The bold and numbered paragraphs below correspond to the numbered paragraphs in the Staff’s letter and are followed by the Company’s responses. Unless otherwise indicated, capitalized terms used herein have the meanings assigned to them in the Tender Offer Statement.

January 24, 2024

Page 2

Schedule TO-I filed January 16, 2024; Offer to Exchange

Conditions of this Offer, page 21

1.We note that you have included a condition ((c)(i)) that will be triggered by “any general suspension of trading in, or limitation on prices for, securities on any national securities exchange or in the over-the-counter market.” Please revise to explain what would be  considered a limitation on prices for securities on any national securities exchange or in the over-the-counter market, or delete this language. Similarly, in condition (c)(iv), please revise to explain what would constitute “any limitation, whether or not mandatory, by any governmental, regulatory or administrative agency or authority on, or any event that might affect, the extension of credit by banks or other lending institutions in the United States,” or delete.

Response: The Company acknowledges the Staff’s comment and, in response to the Staff’s comment, the Company has revised Offer to Exchange to remove the reference to “limitation on prices” from condition (c)(i) and further qualify such condition to national securities exchanges and over-the-counter market in the United States, and remove condition (c)(iv) in question.

2.We note the inclusion of a condition ((c)(iii)) that will be triggered by “the commencement or escalation of a war, armed hostilities or other international or national crisis directly or indirectly involving the United States,” without any materiality qualifier on the gravity of such an event, without requiring any connection between such an event and the Offer, and without limiting the event to one directly involving the United States. The broad wording of this offer condition gives rise to illusory offer concerns under Section 14(e) of the Exchange Act and Regulation 14E thereunder. Please revise to narrow or qualify this condition, or advise. Similarly, we note that condition (c)(v) broadly refers to “any change in the general political, market, economic or financial conditions in the United States or abroad that could have a material adverse effect on the business, condition (financial or other), operations or prospects of Arcutis or on the trading in shares of our Common Stock” (emphasis added). Please revise to narrow or qualify this condition, or advise.

Response: The Company acknowledges the Staff’s comment and, in response to the Staff’s comment, the Company has revised Offer to Exchange to remove conditions (c)(iii) and (c)(v) in question.

Extension of Offer; Termination; Amendment, page 31

3.We note the following disclosure on page 32: “In the case of an extension, the amendment must be issued no later than 8:00 a.m. Pacific Time on the next U.S. business day after the last previously scheduled or announced Offer Expiration Date.” Please note that under Rule 14e-1(d), your announcement must be made no later than 9:00 a.m. Eastern time on the specified date. Please revise.

Response: The Company acknowledges the Staff’s comment and, in response to the Staff’s comment, the Company has revised the relevant language in the Offer to Exchange to refer to 9:00 a.m. Eastern Time.

* * *

January 24, 2024

Page 3

We hope that the foregoing has been responsive to the Staff’s comments and look forward to resolving any outstanding issues as quickly as possible. Please do not hesitate to contact me at 714-755-8051 with any questions or further comments you may have regarding this filing or if you wish to discuss the above.

 Sincerely,

 /s/ J. Ross McAloon

 J. Ross McAloon

 of LATHAM & WATKINS LLP

cc:

Frank Watanabe, Arcutis Biotherapeutics, Inc.

John Smither, Arcutis Biotherapeutics, Inc.

Masaru Matsuda, Arcutis Biotherapeutics, Inc.

Shayne Kennedy, Latham & Watkins LLP
2024-01-23 - UPLOAD - Arcutis Biotherapeutics, Inc. File: 005-91349
United States securities and exchange commission logo
January 23, 2024
Todd Franklin Watanabe
President and Chief Executive Officer
Arcutis Biotherapeutics, Inc.
3027 Townsgate Road, Suite 300
Westlake Village, CA 91361
Re:Arcutis Biotherapeutics, Inc.
Schedule TO-I filed January 16, 2024
File No. 005-91349
Dear Todd Franklin Watanabe:
            We have reviewed your filing and have the following comments. In some of our
comments, we may ask you to provide us with information so we may better understand your
disclosure.
            Please respond to these comments by providing the requested information or advise us as
soon as possible when you will respond. If you do not believe our comments apply to your facts
and circumstances, please tell us why in your response.
            After reviewing your response to these comments, we may have additional comments.
Schedule TO-I filed January 16, 2024; Offer to Exchange
Conditions of this Offer, page 21
1.We note that you have included a condition ((c)(i)) that will be triggered by “any general
suspension of trading in, or limitation on prices for, securities on any national securities
exchange or in the over-the-counter market.” Please revise to explain what would be
considered a limitation on prices for securities on any national securities exchange or in
the over-the-counter market, or delete this language. Similarly, in condition (c)(iv), please
revise to explain what would constitute "any limitation, whether or not mandatory, by any
governmental, regulatory or administrative agency or authority on, or any event that might
affect, the extension of credit by banks or other lending institutions in the United States,"
or delete.
2.We note the inclusion of a condition ((c)(iii)) that will be triggered by "the
commencement or escalation of a war, armed hostilities or other international or national
crisis directly or indirectly involving the United States," without any materiality qualifier
on the gravity of such an event, without requiring any connection between such an event

 FirstName LastNameTodd Franklin Watanabe
 Comapany NameArcutis Biotherapeutics, Inc.
 January 23, 2024 Page 2
 FirstName LastName
Todd Franklin Watanabe
Arcutis Biotherapeutics, Inc.
January 23, 2024
Page 2
and the Offer, and without limiting the event to one directly involving the United States.
The broad wording of this offer condition gives rise to illusory offer concerns under
Section 14(e) of the Exchange Act and Regulation 14E thereunder. Please revise to
narrow or qualify this condition, or advise. Similarly, we note that condition (c)(v)
broadly refers to "any change in the general political, market, economic or financial
conditions in the United States or abroad that could have a material adverse effect on the
business, condition (financial or other), operations or prospects of Arcutis or on the
trading in shares of our Common Stock" (emphasis added). Please revise to narrow or
qualify this condition, or advise.
Extension of Offer; Termination; Amendment, page 31
3.We note the following disclosure on page 32: "In the case of an extension, the amendment
must be issued no later than 8:00 a.m. Pacific Time on the next U.S. business day after the
last previously scheduled or announced Offer Expiration Date." Please note that under
Rule 14e-1(d), your announcement must be made no later than 9:00 a.m. Eastern time on
the specified date. Please revise.
            We remind you that the filing persons are responsible for the accuracy and adequacy of
their disclosures, notwithstanding any review, comments, action or absence of action by the staff.
            Please direct any questions to David Plattner at 202-551-8094.
Sincerely,
Division of Corporation Finance
Office of Mergers and Acquisitions
2023-09-18 - UPLOAD - Arcutis Biotherapeutics, Inc.
United States securities and exchange commission logo
September 18, 2023
John Smither
Interim Chief Financial Officer
Arcutis Biotherapeutics, Inc.
3027 Townsgate Road
Suite 300
Westlake Village , CA 91361
Re:Arcutis Biotherapeutics, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2022
Filed February 28, 2023
File No. 001- 39186
Dear John Smither:
            We have completed our review of your filing.  We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2023-09-15 - CORRESP - Arcutis Biotherapeutics, Inc.
Read Filing Source Filing Referenced dates: September 8, 2023
CORRESP
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September 15, 2023

VIA EDGAR SUBMISSION

U.S. Securities and Exchange Commission

Division of Corporation Finance

Office of Life Sciences

100 F. Street, N.E.

Washington, D.C. 20549

Attn:    Ibolya Ignat

            Mary Mast

Re: Comment Letter dated September 8, 2023

Arcutis Biotherapeutics, Inc.

Form 10-K for the Fiscal Year Ended December 31, 2022

Filed February 28, 2023

File No. 001-39186

To the addressees set forth above:

On behalf of Arcutis Biotherapeutics, Inc. (the “Company”), we hereby submit this letter in response to the comment made by the staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) in a letter from the Staff dated September 8, 2023 (the “Staff Letter”) with respect to the Company’s Form 10-K for the year ended December 31, 2022 filed with the Commission on February 28, 2023 (the “Form 10-K”), as well as the Company’s Form 10-Q for the quarter ended March 31, 2023 filed with the Commission on May 9, 2023 (the “Q1 Form 10-Q”) and Form 10-Q for the quarter ended June 30, 2023 filed with the Commission on August 8, 2023 (the “Q2 Form 10-Q”). For your convenience, we restate the comment from the Staff Letter in bold before our response.

Form 10-K for Fiscal Year Ended December 31, 2022

Exhibits 31.1 and 31.2, page 109

1.We note that your certifications filed as Exhibits 31.1 and 31.2 with your annual report and subsequent interim reports do not include reference to internal control over financial reporting in the introductory language in paragraph 4. Please file an amendment to your annual report and subsequent interim reports that include updated Section 302 and 906 certifications that conform exactly to the language set forth within the Exchange Act Rule 13a-14(a). Refer to Compliance and Disclosure Interpretation 246.13 on Regulation S-K for further guidance.

Response:

            The Company acknowledges to the Staff that it inadvertently omitted the referenced introductory language in paragraph 4 from the certifications filed as Exhibits 31.1 and 31.2 to its Form 10-K, Q1 Form 10-Q and Q2 Form 10-Q. The Company will file on the date hereof amendments to the Form 10-K, Q1 Form 10-Q and Q2 Form 10-Q to provide the revised certifications.

*     *     *     *

Please do not hesitate to contact me by telephone at (714) 755-8051 with any questions or comments regarding this correspondence.

Sincerely,

 /s/ Ross McAloon

Ross McAloon

of LATHAM & WATKINS LLP

cc:

Frank Watanabe, Arcutis Biotherapeutics, Inc.

John Smither, Arcutis Biotherapeutics, Inc.

Masaru Matsuda, Arcutis Therapeutics, Inc.

Shayne Kennedy, Latham & Watkins LLP
2023-09-08 - UPLOAD - Arcutis Biotherapeutics, Inc.
United States securities and exchange commission logo
September 8, 2023
John Smither
Interim Chief Financial Officer
Arcutis Biotherapeutics, Inc.
3027 Townsgate Road
Suite 300
Westlake Village , CA 91361
Re:Arcutis Biotherapeutics, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2022
Filed February 28, 2023
File No. 001- 39186
Dear John Smither:
            We have limited our review of your filing to the financial statements and related
disclosures and have the following comment.  In our comment we may ask you to provide us
with information so we may better understand your disclosure.
            Please respond to the comment within ten business days by providing the requested
information or advise us as soon as possible when you will respond.  If you do not believe our
comment applies to your facts and circumstances, please tell us why in your response.
            After reviewing your response to these comments, we may have additional comments.
Form 10-K for Fiscal Year Ended December 31, 2022
Exhibits 31.1 and 31.2, page 109
1.We note that your certifications filed as Exhibits 31.1 and 31.2 with your annual report
and subsequent interim reports do not include reference to internal control over financial
reporting in the introductory language in paragraph 4.  Please file an amendment to your
annual report and subsequent interim reports that include updated Section 302 and 906
certifications that conform exactly to the language set forth within the Exchange
Act Rule 13a-14(a). Refer to Compliance and Disclosure Interpretation 246.13
on Regulation S-K for further guidance.
            In closing, we remind you that the company and its management are responsible for the
accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or
absence of action by the staff.

 FirstName LastNameJohn Smither
 Comapany NameArcutis Biotherapeutics, Inc.
 September 8, 2023 Page 2
 FirstName LastName
John Smither
Arcutis Biotherapeutics, Inc.
September 8, 2023
Page 2
            You may contact Ibolya Ignat at 202-551-3636, or Mary Mast at 202-551-3613 with any
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2021-05-04 - UPLOAD - Arcutis Biotherapeutics, Inc.
United States securities and exchange commission logo
May 4, 2021
Scott Burrows
Chief Financial Officer
Arcutis Biotherapeutics, Inc.
3027 Townsgate Road Suite 300
Westlake Village , California
Re:Arcutis Biotherapeutics, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2020
Filed February 16, 2021
File No. 001- 39186
Dear Mr. Burrows:
            We have completed our review of your filing.  We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2021-04-23 - CORRESP - Arcutis Biotherapeutics, Inc.
Read Filing Source Filing Referenced dates: April 13, 2021
CORRESP
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 140 Scott Drive

Menlo Park, California  94025

Tel: +1.650.328.4600  Fax: +1.650.463.2600

www.lw.com

FIRM / AFFILIATE OFFICES

Beijing        Moscow

Boston        Munich

Brussels        New York

Century City  Orange County

Chicago        Paris

Dubai        Riyadh

Düsseldorf        San Diego

Frankfurt        San Francisco

Hamburg        Seoul

Hong Kong        Shanghai

Houston        Silicon Valley

London        Singapore

Los Angeles   Tokyo

Madrid         Washington, D.C.

Milan

April 23, 2021

VIA EDGAR AND HAND DELIVERY

United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549-6010

Attention:     Li Xiao, Reviewing Accountant

        Mary Mast, Reviewing Accountant

Re:    Arcutis Biotherapeutics, Inc.
    Form 10-K for the Fiscal Year Ended December 31, 2020

    Filed February 16, 2021

    File No. 001-39186

Ladies and Gentlemen:

On behalf of Arcutis Biotherapeutics, Inc. (the “Company”), we hereby submit this letter in response to the comment made by the staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “SEC”) in a letter from the Staff dated April 13, 2021 (the “Staff Letter”).

For your convenience, we restate the comment from the Staff Letter in bold before our response.

Form 10-K for the Fiscal Year Ended December 31, 2020

Management’s Discussion and Analysis of Financial Condition and Results of Operations

Research and Development Expense, page 91

1.You present a table of direct and indirect costs on page 91 and disclose on page 89 that you allocate direct external costs to your product candidates.  Considering that your product candidates are now in more advanced late stages of clinical trials, please provide disaggregated disclosure for external costs by product candidate or indication incurred for each period or tell us why additional disclosure cannot be provided.

April 23, 2021

Page 2

Response: The Company respectfully acknowledges the Staff’s comment and confirms that it, consistent with the discussion of the undersigned, intends to provide disaggregated disclosure for direct external costs by development program in its future annual and quarter filings under the Securities Exchange Act of 1934, as amended, beginning with the Company’s upcoming filing on Form 10-Q for the quarter ended March 31, 2021.

* * *

Please do not hesitate to contact me by telephone at (650) 463-3014 with any questions or comments regarding this correspondence.

Very truly yours,

/s/ Brian J. Cuneo

Brian J. Cuneo

of LATHAM & WATKINS LLP

cc:     Frank Watanabe, Arcutis Biotherapeutics, Inc.

    Scott Burrows, Arcutis Biotherapeutics, Inc.

    Keith Klein, Arcutis Therapeutics, Inc.

    Ross McAloon, Latham & Watkins LLP
2021-04-13 - UPLOAD - Arcutis Biotherapeutics, Inc.
United States securities and exchange commission logo
April 13, 2021
Scott Burrows
Chief Financial Officer
Arcutis Biotherapeutics, Inc.
3027 Townsgate Road Suite 300
Westlake Village , California
Re:Arcutis Biotherapeutics, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2020
Filed February 16, 2021
File No. 001- 39186
Dear Mr. Burrows:
            We have limited our review of your filing to the financial statements and related
disclosures and have the following comment.  In our comment, we may ask you to provide us
with information so we may better understand your disclosure.
            Please respond to the comment within ten business days by providing the requested
information or advise us as soon as possible when you will respond.  If you do not believe our
comment applies to your facts and circumstances, please tell us why in your response.
            After reviewing your response to the comment, we may have additional comments.
Form 10-K for the Fiscal Year Ended December 31, 2020
Management's Discussion and Analysis of Financial Condition and Results of Operations
Results of Operations
Research and Development Expenses, page 91
1.You present a table of direct and indirect costs on page 91 and disclose on page 89 that
you allocate direct external costs to your product candidates.  Considering that your
product candidates are now in more advanced late stages of clinical trials, please
provide disaggregated disclosure for external costs by product candidate or
indication incurred for each period or tell us why additional disclosure cannot be
provided.
            In closing, we remind you that the company and its management are responsible for the
accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or
absence of action by the staff.

 FirstName LastNameScott  Burrows
 Comapany NameArcutis Biotherapeutics, Inc.
 April 13, 2021 Page 2
 FirstName LastName
Scott  Burrows
Arcutis Biotherapeutics, Inc.
April 13, 2021
Page 2
            You may contact Li Xiao at (202) 551-4391 or Mary Mast at (202) 551-3613 with any
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2020-09-29 - CORRESP - Arcutis Biotherapeutics, Inc.
CORRESP
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Arcutis Biotherapeutics, Inc.

2945 Townsgate Road, Suite 110

Westlake Village, CA 91361

September 29, 2020

VIA EDGAR AND E-MAIL

United States Securities and Exchange Commission

Division of Corporation Finance

100 F Street, N.E.

Washington, D.C. 20549

Attention:     Tim Buchmiller

Re:    Arcutis Biotherapeutics, Inc. Registration Statement on Form S-1 (Registration No. 333-249124)

Ladies and Gentlemen:

In accordance with Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, we hereby request acceleration of the effective date of the Registration Statement on Form S-1 (File No. 333-249124) (the “Registration Statement”) of Arcutis Biotherapeutics, Inc. (the “Company”). We respectfully request that the Registration Statement become effective as of 4:30 p.m., Washington, D.C. time, on October 1, 2020, or as soon as practicable thereafter, or at such other time as our legal counsel, Latham & Watkins LLP, may request by telephone to the staff of the U.S. Securities and Exchange Commission. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Latham & Watkins LLP, by calling Brian Cuneo at (650) 463-3014.

Thank you for your assistance in this matter.

  Very truly yours,

  Arcutis Biotherapeutics, Inc.

  By:

 /s/ John W. Smither

   John W. Smither

   Chief Financial Officer

CC: Todd Franklin Watanabe, Arcutis Biotherapeutics, Inc.

 Brian J. Cuneo, Latham & Watkins LLP

 J. Ross McAloon, Latham & Watkins LLP

 Kristin VanderPas, Cooley LLP
2020-09-29 - CORRESP - Arcutis Biotherapeutics, Inc.
CORRESP
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September 29, 2020

United States Securities and Exchange Commission

Division of Corporation Finance

100 F Street, N.E.

Washington, DC 20549

Atterntion:   Tim Buchmiller

Re:    Arcutis Biotherapeutics, Inc.

Registration Statement on Form S-1 (File No. 333-249124)

Ladies and Gentlemen:

Pursuant to Rule 460 of the General Rules and Regulations under the Securities Act of 1933, as amended (the “Securities Act”), we wish to advise that as of the time of this filing, the underwriters have not yet made any distribution of the Preliminary Prospectus of Arcutis Biotherapeutics, Inc. (the “Registrant”), dated September 29, 2020. However, the underwriters are taking steps to see that all underwriters, brokers or dealers participating in the public offering of shares of the Registrant’s common stock pursuant to the above-captioned Registration Statement, as amended (the “Registration Statement”), are promptly furnished with sufficient copies of the preliminary and final prospectus to enable them to comply with the prospectus delivery requirements of Sections 5(b)(1) and (2) of the Securities Act.

We wish to advise you that the participating underwriters have complied and will continue to comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.

In accordance with Rule 461 of the General Rules and Regulations under the Securities Act, we hereby join in the request of the Registrant that the effectiveness of the above-captioned Registration Statement be accelerated to 4:30 p.m. Eastern Time, on Thursday, October 1, 2020, or as soon thereafter as practicable.

[Signature page follows]

Very truly yours,

GOLDMAN SACHS & CO. LLC

COWEN AND COMPANY, LLC

GUGGENHEIM SECURITIES, LLC

As representatives of the Underwriters

By: Goldman Sachs & Co. LLC

By:   /s/ Elizabeth Wood

 Name: Elizabeth Wood

 Title:    Managing Director

By: Cowen and Company, LLC

By:   /s/ E. James Streator, III

 Name: E. James Streator, III

 Title:    Managing Director

By: Guggenheim Securities, LLC

By:   /s/ Shiv Taylor

 Name: Shiv Taylor

 Title:    Senior Managing Director
2020-07-27 - UPLOAD - Arcutis Biotherapeutics, Inc.
United States securities and exchange commission logo
July 27, 2020
John W. Smither
Chief Financial Officer
Arcutis Biotherapeutics, Inc.
2945 Townsgate Road, Suite 110
Westlake Village, California 91361
Re:Arcutis Biotherapeutics, Inc.
Draft Registration Statement on Form S-1
Submitted July 21, 2020
CIK No. 0001787306
Dear Mr. Smither:
            This is to advise you that we do not intend to review your registration statement.
            We request that you publicly file your registration statement no later than 48 hours prior
to the requested effective date and time. Please refer to Rules 460 and 461 regarding requests for
acceleration. We remind you that the company and its management are responsible for the
accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or
absence of action by the staff.
            Please contact Tim Buchmiller at (202) 551-3635 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Brian J. Cuneo, Esq.
2020-01-28 - CORRESP - Arcutis Biotherapeutics, Inc.
CORRESP
1
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CORRESP

 Arcutis Biotherapeutics, Inc.

2945 Townsgate Road, Suite 110

 Westlake Village, CA 91361

January 28, 2020

 VIA EDGAR

United States Securities and Exchange Commission

 Division of
Corporation Finance

 100 F Street, NE

 Washington, DC 20549

Attention:
 Julia Griffith

 Dietrich King

 Christine Torney

 Angela Connell

Re:
 Arcutis Biotherapeutics, Inc. Registration Statement on Form S-1 (File No. 333-235806) originally filed January 6, 2020, as amended, and corresponding Registration Statement on Form 8-A (File
No. 001-39186) filed January 21, 2020.

 Requested Date: January 30, 2020

Requested Time: 4:00 PM Eastern Time

 Ladies and Gentlemen:

Arcutis Biotherapeutics, Inc. (the “Registrant”) hereby requests that the Securities and Exchange Commission take
appropriate action to declare the above-captioned Registration Statements on Form S-1 and Form 8-A effective at the “Requested Date” and “Requested Time” set forth above or as soon thereafter as practicable.

The Registrant hereby authorizes Robert A. Freedman or Julia Forbess, both of whom are attorneys with the Registrant’s outside legal
counsel, Fenwick & West LLP, to orally modify or withdraw this request for acceleration.

 The Registrant requests that it be
notified of such effectiveness by a telephone call to Mr. Freedman at (650) 335-7292 or, in his absence, Ms. Forbess at (415) 875-2420.

* * *

Sincerely,

ARCUTIS BIOTHERAPEUTICS, INC.

By:

 /s/ Todd Franklin Watanabe

Todd Franklin Watanabe

Chief Executive Officer

cc:
 Todd Franklin Watanabe, Chief Executive Officer

 Arcutis Biotherapeutics, Inc.

 Robert A. Freedman, Esq.

 Matthew Rossiter, Esq.

 Fenwick & West LLP
2020-01-28 - CORRESP - Arcutis Biotherapeutics, Inc.
CORRESP
1
filename1.htm

CORRESP

 January 28, 2020

 VIA
EDGAR

 United States Securities and Exchange Commission

 Division of
Corporation Finance

 100 F Street, NE

 Washington, DC 20549

Attention:
 Julia Griffith

 Dietrich King

 Christine Torney

 Angela Connell

Re:
 Arcutis Biotherapeutics, Inc. Registration Statement on Form S-1 (File No. 333-235806) originally filed January 6, 2020, as amended.

 Requested Date: January 30, 2020

 Requested Time: 4:00 PM Eastern Time

 Ladies and Gentlemen:

In accordance with Rule 461 under the Securities Act of 1933, as amended (the “Act”), we, as the representatives of the
several underwriters, hereby join in the request of Arcutis Biotherapeutics, Inc. (the “Registrant”) that the Securities and Exchange Commission take appropriate action to declare the above-captioned Registration Statements
on Form S-1 effective at the “Requested Date” and “Requested Time” set forth above, or as soon thereafter as practicable, or at such other time as the Registrant or its outside counsel, Fenwick & West LLP,
may request via telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission.

 Pursuant to
Rule 460 under the Act, we, as the representatives of the several underwriters, wish to advise you that between January 21, 2020 through the date hereof we have distributed approximately 3,276 copies of the Registrant’s Preliminary
Prospectus dated January 21, 2020 to prospective underwriters, dealers, institutional investors and others.

 We, the undersigned, as the
representatives of the several underwriters, have complied and will comply, and we have been informed by the participating underwriters that they have complied and will comply, with the requirements of
Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.

 * * *

 Sincerely,

GOLDMAN SACHS & CO. LLC

COWEN AND COMPANY, LLC

As representatives of the several Underwriters

GOLDMAN SACHS & CO. LLC

By:

/s/ Sonia M. Gupta

 Name: Sonia M. Gupta

 Title: Managing Director

COWEN AND COMPANY, LLC

By:

/s/ Bill Follis

 Name: Bill Follis

 Title: Managing Director
2020-01-13 - CORRESP - Arcutis Biotherapeutics, Inc.
Read Filing Source Filing Referenced dates: October 4, 2019
CORRESP
1
filename1.htm

CORRESP

 ROBERT A. FREEDMAN

January 13, 2020

 EMAIL
RFREEDMAN@FENWICK.COM

 Direct Dial (650)
335-7292

CERTAIN PORTIONS OF THIS LETTER AS FILED VIA EDGAR HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR THE OMITTED PORTIONS, WHICH HAVE BEEN REPLACED WITH THE FOLLOWING PLACEHOLDER: “[***].” THE OMITTED PORTIONS HAVE BEEN BRACKETED IN THIS UNREDACTED COPY OF
THE LETTER FOR EASE OF IDENTIFICATION.

 VIA EDGAR AND OVERNIGHT DELIVERY

U.S. Securities and Exchange Commission

 Division of Corporation
Finance

 100 F Street, NE

 Washington, DC 20549

Attention:

 Julia Griffith

 Dietrich King

Christine Tourney

Angela Connell

Re:

 Arcutis Biotherapeutics, Inc.

Registration Statement on Form S-1

Filed January 6, 2020

 File No. 333-235806

 Ladies and Gentlemen:

On behalf of Arcutis Biotherapeutics, Inc. (the “Company”), we submit this letter to assist the staff (the
“Staff”) of the Securities and Exchange Commission (the “Commission”) in its review of the Company’s Registration Statement on Form S-1 (File No. 333-235806) (the “Registration Statement”), to further address comment 10 of the Staff set forth in its letter to the Company dated October 4, 2019, concerning valuation
considerations related to the Company’s equity awards. For the convenience of the Staff, we are providing to the Staff by overnight delivery copies of this letter.

Confidential Treatment Request

 Because
of the commercially sensitive nature of information contained herein, this submission is accompanied by the Company’s request for confidential treatment of selected portions of this letter pursuant to Rule 83 of the Commission’s Rules on
Information and Requests, 17 C.F.R. § 200.83 and the Freedom of Information Act.

 CONFIDENTIAL TREATMENT
REQUESTED BY ARCUTIS BIOTHERAPEUTICS, INC.

 1

 Securities and Exchange Commission

Division of Corporation Finance

 January 13, 2020

 Page
 2

 Preliminary IPO Price Range

We advise the Staff that the Company currently anticipates that it will include a price range in its preliminary prospectus for the proposed
offering that will be between $[***] and $[***] per share (the “Preliminary Price Range”) with a midpoint of anticipated range of approximately $[***]. The Company plans to effect a reverse stock split in connection with its
Offering pursuant to a future amendment of the Company’s certificate of incorporation that will be filed with the Secretary of State of the State of Delaware before filing the Preliminary Prospectus with the Commission (the “Stock
Split”). The share numbers and stock prices set forth in this letter do not reflect the Stock Split and are all pre-split.

The Preliminary Price Range has been determined based, in part, upon current market conditions and the input received from the lead
underwriters on the proposed initial public offering (the “Offering”), including discussions that took place on January 3, 2020 among the senior management of the Company and discussions on January 10, 2019 among
the Pricing Committee of the Company’s Board of Directors (the “Board”) and senior management of the Company. Prior to January 3, 2020, the senior management of the Company had not held formal discussions with the
underwriters regarding a price range for the Offering. Additionally, on December 20, 2019 the senior management of the Company held preliminary and informal discussions with the lead underwriters regarding a potential price range for the
Offering. The Preliminary Price Range does not take into account the current lack of liquidity for the Company’s common stock (“Common Stock”) and assumes a successful Offering in late January 2020 with no weighting
attributed to any other outcome for the Company’s business, such as remaining a privately held company or being sold to a third party.

The Company also notes that it will set forth a bona fide offering price range in a pre-effective
amendment to the Registration Statement (the “Bona Fide Price Range”) prior to the distribution of any preliminary prospectus, but the parameters of the Bona Fide Price Range will be subject to then-current market conditions,
continuing discussions with the underwriters, as well as further business and market developments affecting the Company. The spread within the Bona Fide Price Range will be no more than 20%. The Company expects to include the Bona Fide Price Range
in an amendment to the Registration Statement that would shortly precede the commencement of the Company’s public marketing process, which it anticipates could commence as soon as January 21, 2020.

Fair Value Determinations

 Given the
absence of an active market for the Common Stock, the Board was required to estimate the fair value of the Common Stock at the time of each equity-based award based upon several factors, including the Board’s consideration of input from
management and third-party valuations.

 We supplementally advise the Staff that, as described on pages 96 through 97 of the Registration
Statement, the Board has considered a variety of factors in determining the fair value of the Common Stock for purposes of granting stock options to date. Due to the absence of an active market for the Common Stock, the fair value of its Common
Stock was determined in good faith by the Board, with the assistance and upon the recommendation of management and valuations of the Common Stock prepared by an unrelated third-party valuation firm, based on a number of objective and subjective
factors consistent with the methodologies outlined in the American Institute of Certified Public Accountants Practice Aid, Valuation of Privately-Held-Company Equity Securities Issued as Compensation, referred to as the AICPA Practice Aid,
including:

 CONFIDENTIAL TREATMENT
REQUESTED BY ARCUTIS BIOTHERAPEUTICS, INC.

 2

 Securities and Exchange Commission

Division of Corporation Finance

 January 13, 2020

 Page
 3

•

 contemporaneous valuations of its shares of Common Stock;

•

 the prices of each of series of preferred stock sold by the Company to outside investors in arm’s length
transactions, and the rights, preferences and privileges of each of these series of preferred stock relative to its Common Stock;

•

 the Company’s results of operations, financial position and the status of its research and development
efforts;

•

 the composition of the management team and Board;

•

 the material risks related to the business;

•

 the market performance of publicly traded companies in the life sciences and biotechnology sectors;

•

 the likelihood of achieving a liquidity event for the holders of shares of Common Stock, such as a sale of the
company or an initial public offering, given prevailing market conditions;

•

 the lack of marketability of the Common Stock; and

•

 external market conditions affecting the life sciences and biotechnology industry sectors.

A summary of the Company’s stock option grants and the associated valuations for the period starting January 1, 2019 through the
date of this letter are below:

 Grant date

Number
of common
shares
underlying
options
granted(1)

Exercise
price or
purchase
per
share of
Common
Stock

Estimated
fair value
per share
of
Common
Stock

 Valuation date

 March 5, 2019

373,750

$
0.84

$
0.84

August 31, 2018

 March 13, 2019

1,767,200

$
0.84

$
0.84

August 31, 2018

 May 14, 2019

550,000

$
0.84

$
0.84

August 31, 2018

 June 11, 2019

240,000

$
0.84

$
0.84

August 31, 2018

 October 18, 2019

340,000

$
3.26

$
3.26

September 25, 2019

 October 28, 2019

580,000

$
3.26

$
3.26

September 25, 2019

 November 20, 2019

1,083,500

$
3.26

$
3.26

September 25, 2019

 December 18, 2019(2)

26,500

$
0.29

$
3.26

September 25, 2019

(1)
 All grants are stock option grants unless otherwise indicated.

(2)
 Restricted stock grant.

Major company events that indicated an increase in value were used as inflection points to obtain additional financing, as such valuations
were performed in conjunction with issuance of convertible preferred stock, which were determined to be arms-length transactions. The valuation performed on August 31, 2018 was based on the Company’s Series B convertible preferred stock
financing (the “Series B Financing”), which contemplated increases in value associated with the AstraZeneca license agreement entered into in July 2018, as well as Company progress to that date, including the results of the
Company’s

 CONFIDENTIAL TREATMENT
REQUESTED BY ARCUTIS BIOTHERAPEUTICS, INC.

 3

 Securities and Exchange Commission

Division of Corporation Finance

 January 13, 2020

 Page
 4

Phase 2a study in psoriasis. Major Company events which reflected additional increases in value after the August 31, 2018 valuation were reflected in the valuation performed as of
September 25, 2019 and included the Company’s Series C convertible preferred stock financing (the “Series C Financing”), which closed in October 2019 but was included in the analysis, the results of the Phase 2b
study in psoriasis, completed in July 2019, as well as the Company’s progress towards an initial public offering (“IPO”) that started with the organizational meeting in August 2019, which allowed the reasonable
estimation of the form and timing of potential liquidity events.

 The dates of the valuations were not contemporaneous with the grant
dates of the Company’s equity awards. Therefore, the Company considered the amount of time between the valuation date and the grant date to determine whether to use the latest Common Stock valuation for the purposes of determining the estimated
fair value of its Common Stock for financial reporting purposes. For grants made between the dates of the valuations, when the Board determined that there had not been any significant changes in the equity value of the Company, it used the fair
value of the Common Stock as of the date of the most current valuation report, taking into consideration the factors noted above.

 Summary of Method
Used by Valuation Date

 For the August 31, 2018 valuation, the Company utilized the Backsolve Method, which utilized the recent
Series B Financing and applied the Black-Scholes option pricing method (“OPM”), which is an accepted valuation method under the AICPA Practice Guide, for determining the fair value of its Common Stock. The OPM values each
equity class by creating a series of call options on the equity value, with exercise prices based on the liquidation preferences, participation rights and strike prices of derivatives. The Backsolve Method was utilized as the Company determined that
the Series B Financing was an arms-length transaction and because the Company could not reasonably estimate the form and timing of potential liquidity events as of the time of grant for awards issued prior to October 18, 2019. At each grant
date, the Board considered whether any events occurred that would trigger any material changes to the business or would require adjustment to the fair value of its Common Stock. For the September 25, 2019 valuation, the Company has applied the
hybrid method for determining the fair value of its Common Stock, as discussed below. The Company elected to utilize the hybrid method as estimates regarding potential outcomes were considered reasonable.

At each grant date, the Board considered whether any events occurred that would trigger any material changes to the estimated fair value of
the business from the previous valuation date. Under the hybrid method, the per share value of the Common Stock is estimated based upon the probability-weighted present value of expected future equity values for the Common Stock, under various
possible future liquidity event scenarios, in light of the rights and preferences of each class of stock, discounted for a lack of marketability.

The restricted stock award granted on December 18, 2019 was issued in replacement of vested options that had expired with a purchase
price that was less than the fair market value on the date of grant. The difference between the purchase price and fair market value will be recognized as compensation expense in the fourth quarter of fiscal 2019.

 CONFIDENTIAL TREATMENT
REQUESTED BY ARCUTIS BIOTHERAPEUTICS, INC.

 4

 Securities and Exchange Commission

Division of Corporation Finance

 January 13, 2020

 Page
 5

 Summary of Most Recent Valuation

On October 18, 2019, the Company determined the fair value of its Common Stock to be $3.26 per share (the “Estimated Fair Value
Per Share”). This determination was based in part on a third-party valuation conducted as of September 25, 2019 (the “September 25 Valuation”) utilizing the hybrid method.
For purposes of the Estimated Fair Value Per Share, the Company anticipated a [***]% probability of an IPO event to occur in January 2020 and a [***]% probability of an IPO event to occur in December 2020. However, the likelihood of the Company
consummating an IPO in the near-term was not certain, and due to market uncertainty and various strategic business factors, the Company also considered alternative scenarios for the Company. Ultimately, the Company determined the Estimated Fair
Value Per Share assuming three potential future events:

(i)
 an IPO in January 2020 (the “Early IPO”);

(ii)
 an IPO in December 2020 (the “Late IPO”); and

(iii)
 the Company continuing to remain privately held (“Stay Private”).

 The Board, in consultation with management, weighted the aggregate probability of an IPO at [***]% and Stay Private
scenario at [***]%. The Board also determined that it was more likely that an IPO would occur in January 2020 as compared to potential alternative IPO timing scenarios occurring in December 2020. The Company believes that the potential future events
used in the September 25 Valuation and the probability weighting of each future event was appropriate at the time, in light of the Company’s stage of development, operating results, its prospects for an IPO in the near term, general
conditions in the capital markets, including with respect to IPOs, and the relative likelihood of achieving a liquidity event such as an IPO in light of prevailing market conditions. The timing of these future liquidity event scenarios was
determined based primarily on input from the Board and management.

 Discussion of Estimated Fair Value Per Share Results

As noted above, the hybrid method allocates the projected equity value to each share class at each potential future event date, taking into
consideration the rights and preferences of each class of equity and the anticipated timing of each event, and then discounts the results to present value using an appropriate risk adjusted discount rate. A discount for lack of marketability is then
applied, as the Company is a closely held, non-public company with no ready market for its shares, to arrive at an estimated fair value per share for each event. Finally, the estimated fair values per share
are probability weighted to arrive at a probability-weighted fair value per share.

 To derive its equity value in the Early IPO and Late
IPO scenarios, the Company relied upon an analysis of similarly situated comparable companies at the time of their IPOs. For the Stay Private scenario, the Company estimated an equity value by applying the Backsolve Method based on the
Company’s Series C Financing, which closed on October 8, 2019. After estimating the Company’s total equity value based on the sale price of the Company’s Series C Financing, that value was allocated to the various classes of the
Company’s equity using the OPM.

 The selection of the discount for lack of marketability was based on the Protective Put Method, a
method of estimating a discount for lack of marketability using the OPM as outlined in the AICPA Practice Guide. This method considers the duration of any restrictions or period of anticipated illiquidity in each of the IPO scenari
2019-10-31 - UPLOAD - Arcutis Biotherapeutics, Inc.
October 31, 2019
Todd Franklin Watanabe
Chief Executive Officer
Arcutis, Inc.
2945 Townsgate Rd., Suite 110
Westlake Village
CA 91361
Re:Arcutis, Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted October 21, 2019
CIK No. 0001787306
Dear Mr. Watanabe:
            We have reviewed your amended registration statement and have the following
comments.  In some of our comments, we may ask you to provide us with information so we
may better understand your disclosure.
            Please respond to this letter by amending your registration statement and providing the
requested information.  If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
            After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.  Unless we note
otherwise, our references to prior comments are to comments in our October 4, 2019 letter.
Amendment No. 1 to Draft Registration Statement on Form S-1
Overview, page 1
1.We note your revised disclosure in response to comment 1.  Please further revise your
disclosure to more broadly acknowledge the widespread use of accepted treatments for the
applications that you are considering.  In addition, please remove references to the relative
safety and efficacy of various treatments, as safety and efficacy are uniquely within the
purview of the FDA.

 FirstName LastNameTodd Franklin Watanabe
 Comapany NameArcutis, Inc.
 October 31, 2019 Page 2
 FirstName LastName
Todd Franklin Watanabe
Arcutis, Inc.
October 31, 2019
Page 2
            You may contact Christine Torney at 202-551-3652 or Angela Connell at 202-551-3426
if you have questions regarding comments on the financial statements and related
matters.  Please contact Julia Griffith at 202-551-3267 or Dietrich King at 202-551-8071 with
any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2019-10-07 - UPLOAD - Arcutis Biotherapeutics, Inc.
October 4, 2019
Todd Franklin Watanabe
Chief Executive Officer
Arcutis, Inc.
2945 Townsgate Rd., Suite 110
Westlake Village
CA 91361
Re:Arcutis, Inc.
Draft Registration Statement on Form S-1
Submitted September 9, 2019
CIK No. 0001787306
Dear Mr. Watanabe:
            We have reviewed your draft registration statement and have the following comments.  In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
            Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR.  If you do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
            After reviewing the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Draft Registration Statement on Form S-1
Overview, page 1
1.Please expand the disclosure in the discussion of unmet need to clarify that there are
numerous available therapies for the conditions that you are proposing to treat.  Further,
since conclusions regarding the efficacy and safety of available treatments are uniquely
within the purview of the FDA, please revise your disclosure throughout your prospectus
to eliminate conclusory statements regarding safety and efficacy.
2.Please tell us the basis for your statement at the bottom of page 1 that traditional therapies
"offer inadequate efficacy."

 FirstName LastNameTodd Franklin Watanabe
 Comapany NameArcutis, Inc.
 October 4, 2019 Page 2
 FirstName LastNameTodd Franklin Watanabe
Arcutis, Inc.
October 4, 2019
Page 2
3.Please expand your description of "IC50 values" to provide context for the term.  In
addition, please define technical terms and terms of art (e.g. "hematopoietic adverse
effects," p. 7) where they first appear in the prospectus.
4.We note the inclusion of Vitiligo and Alopecia Areata in the pipeline table on page 2, and
references to your product candidate ARQ-252 having applications for hand eczema "and
potentially vitiligo and alopecia areata."  Please expand your pipeline table and your
disclosure to provide more information about the company's progress with respect to pre-
clinical trials for these applications.  If you have undertaken IND enabling studies,
describe these studies in the disclosure.  Alternatively, please delete these applications
from the pipeline table and throughout your document.
5.Considering your stage of development, tell us the basis for your belief that your pipeline
of therapeutics will be "best in class in immune-dermatology."
Implications of Being an Emerging Growth Company, page 8
6.Please supplementally provide us with copies of all written communications, as defined in
Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf,
present to potential investors in reliance on Section 5(d) of the Securities Act, whether or
not they retain copies of the communications.
Risk Factors, page 14
7.We note that there are references to foreign regulators and foreign markets throughout the
Risk Factors and other sections of your prospectus.  Please revise to explain what non-US
markets, if any, you plan to enter, and what steps you have taken to attain the necessary
regulatory and patent approvals.
Use of Proceeds, page 72
8.Please clarify whether you believe the net proceeds of the offer will be sufficient to
complete the Phase 1 clinical trials for the products disclosed in your pipeline table, or in
the case of ARQ-151, Phase 2 and 3 clinical trials, and if not, how far into those trials you
expect the proceeds to last.
Management's Discussion and Analysis of Financial Condition and Results of Operations, page
82
9.We note your reference on page 82 to "potential collaboration agreements."  Please
confirm that all material information regarding collaboration agreements and discussions
of such agreements has been disclosed.

 FirstName LastNameTodd Franklin Watanabe
 Comapany NameArcutis, Inc.
 October 4, 2019 Page 3
 FirstName LastName
Todd Franklin Watanabe
Arcutis, Inc.
October 4, 2019
Page 3
Management's Discussion and Analysis of Financial Condition and Results of Operations
Critical Accounting Policies and Use of Estimates
Stock Based Compensation
Common Stock Valuation, page 94
10.Once you have an estimated offering price or range, please explain to us how you
determined the fair value of the common stock underlying your equity issuances and the
reasons for any differences between the recent valuations of your common stock leading
up to the IPO and the estimated offering price. This information will help facilitate our
review of your accounting for equity issuances including stock compensation and
beneficial conversion features.
Notes to Condensed Financial Statements
6. Related Party Transactions
Hawkeye Collaboration Agreement, page F-44
11.Please revise to disclose the significant terms of the Hawkeye Collaboration Agreement,
including any upfront payments made or received and any future milestones or royalties.
General
12.Please provide us mockups of any pages that include any additional pictures or graphics to
be presented, including any accompanying captions. Please keep in mind, in scheduling
your printing and distribution of the preliminary prospectus, that we may have comments
after our review of these materials.
            You may contact Christine Torney at 202-551-3652 or Angela Connell at 202-551-3426
if you have questions regarding comments on the financial statements and related
matters.  Please contact Julia Griffith at 202-551-3267 or Dietrich King at 202-551-8071 with
any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences

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