SEC Comment Letter 0000000000-23-012787 to MADRIGAL PHARMACEUTICALS, INC. (MDGL) (CIK 0001157601) (MDGL)
MADRIGAL PHARMACEUTICALS, INC. (MDGL) (CIK 0001157601)
Date: Nov. 21, 2023 · CIK: 0001157601 · Accession: 0000000000-23-012787
AI Filing Summary & Sentiment
File numbers found in text: 001-33277
Letter
United States securities and exchange commission logo November 21, 2023 Alex G. Howarth Chief Financial Officer Madrigal Pharmaceuticals, Inc. Four Tower Bridge 200 Barr Harbor Drive, Suite 200 West Conshohocken, PA 19428 Re:Madrigal Pharmaceuticals, Inc. Form 10-K for Fiscal Year Ended December 31, 2022 File No. 001-33277 Dear Alex G. Howarth: We have reviewed your filing 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 Fiscal Year Ended December 31, 2022 Dual Primary Endpoints (52 Weeks) and Key Secondary Endpoint (24 weeks), page 9 1.We note your disclosure on page 10 that Resmetirom was safe and well tolerated. Determinations related to safety are within the sole authority of the FDA. In future filings, please refrain from making such assessments related to product candidates that have not been approved. Additionally, please disclose all serious adverse events related to Resmetirom and disclose the number of such events. Explain how you have determined that the candidate is well tolerated when trial participants experienced serious adverse events. Research and Development Expenses, page 65 2.We note the statement that you expect your research and development expenses will increase substantially in the future. Accordingly for each period presented in future filings, please revise to provide a breakdown of the amount of research and development expense incurred for each of your lead product candidates by program. For product candidates with more than one application, provide a breakdown by indication. To the
FirstName LastNameAlex G. Howarth Comapany NameMadrigal Pharmaceuticals, Inc. November 21, 2023 Page 2 FirstName LastName Alex G. Howarth Madrigal Pharmaceuticals, Inc. November 21, 2023 Page 2 extent that you do not track expenses by product candidate, program, or indication, please disclose that fact and explain why you do not maintain and evaluate research and development cost in this manner. For all unallocated research and development expense, provide a breakdown by type or nature of expense such that the sum reconciles to total research and development expense for the period. 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 Gary Newberry at 202-551-3761 or Kevin Kuhar at 202-551-3662 if you have questions regarding comments on the financial statements and related matters. Sincerely, Division of Corporation Finance Office of Life Sciences
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United States securities and exchange commission logo
November 21, 2023
Alex G. Howarth
Chief Financial Officer
Madrigal Pharmaceuticals, Inc.
Four Tower Bridge
200 Barr Harbor Drive, Suite 200
West Conshohocken, PA 19428
Re:Madrigal Pharmaceuticals, Inc.
Form 10-K for Fiscal Year Ended December 31, 2022
File No. 001-33277
Dear Alex G. Howarth:
We have reviewed your filing 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 Fiscal Year Ended December 31, 2022
Dual Primary Endpoints (52 Weeks) and Key Secondary Endpoint (24 weeks), page 9
1.We note your disclosure on page 10 that Resmetirom was safe and well tolerated.
Determinations related to safety are within the sole authority of the FDA. In future filings,
please refrain from making such assessments related to product candidates that have not
been approved. Additionally, please disclose all serious adverse events related to
Resmetirom and disclose the number of such events. Explain how you have determined
that the candidate is well tolerated when trial participants experienced serious adverse
events.
Research and Development Expenses, page 65
2.We note the statement that you expect your research and development expenses will
increase substantially in the future. Accordingly for each period presented in future
filings, please revise to provide a breakdown of the amount of research and development
expense incurred for each of your lead product candidates by program. For product
candidates with more than one application, provide a breakdown by indication. To the
FirstName LastNameAlex G. Howarth
Comapany NameMadrigal Pharmaceuticals, Inc.
November 21, 2023 Page 2
FirstName LastName
Alex G. Howarth
Madrigal Pharmaceuticals, Inc.
November 21, 2023
Page 2
extent that you do not track expenses by product candidate, program, or indication, please
disclose that fact and explain why you do not maintain and evaluate research and
development cost in this manner. For all unallocated research and development expense,
provide a breakdown by type or nature of expense such that the sum reconciles to total
research and development expense for the period.
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 Gary Newberry at 202-551-3761 or Kevin Kuhar at 202-551-3662 if you
have questions regarding comments on the financial statements and related matters.
Sincerely,
Division of Corporation Finance
Office of Life Sciences