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SEC Company Response from PTC THERAPEUTICS, INC. (PTCT) (CIK 0001070081) (PTCT) — Oct 19, 2021

PTC THERAPEUTICS, INC. (PTCT) (CIK 0001070081)
Date: Oct. 19, 2021 · CIK: 0001070081 · Accession: 0001104659-21-127548

AI Filing Summary & Sentiment

File numbers found in text: 001-35969

Referenced dates: August 26, 2021, October 6, 2021

Date
October 19, 2021
Author
/s/ Emily Hill
Form
CORRESP
Company
PTC THERAPEUTICS, INC. (PTCT) (CIK 0001070081)

Letter

Office of Life Sciences United States Securities and Exchange Commission Division of Corporation Finance PTC Therapeutics, Inc. Form 10-K for the Fiscal Year Ended December 31, 2020 Response dated September 23, 2021 File No. 001-35969

Dear Mr. Newberry and Ms. Mast:

This letter is submitted on behalf of PTC Therapeutics, Inc. (the “Company” or “PTC”) in response to written comments of the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) in the letter dated October 6, 2021 with respect to the Company’s response dated September 23, 2021 to the Staff’s letter dated August 26, 2021 with respect to PTC’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020, as filed with the Commission on February 25, 2021 (the “2020 Form 10-K”). The Staff’s comment is reproduced below and the Company’s corresponding response follows accordingly.

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

Management’s Discussion and Analysis

Results of Operations for the years ended December 31, 2020 and 2019

Net product revenue, page 153

1. We acknowledge your response to comment number 1, but respectively believe that disclosure of product revenue by each significant product would be useful information for an investor, even if there are only two products. Please confirm that you will provide disclosure in future filings. To the extent that one of the products is not generating significant product revenue, please state that fact. Also, revise to provide disaggregated information by product in your financial statements pursuant to ASC 606-10-55-89 through 55-91 or tell us how you have met the disclosure requirements.

Response: The Company confirms that in future filings it will disclose the product revenue of each significant product in the narrative of the “Net product revenue” subsection of “Management’s Discussion and Analysis”.

The following paragraph, with an updated narrative for the fiscal year ended December 31, 2020, reflects how PTC plans to enhance its disclosures in its future filings:

Net product revenues. Net product revenue was $333.4 million for the year ended December 31, 2020, an increase of $42.1 million, or 14%, from net product revenue of $291.3 million for the year ended December 31, 2019, primarily stemming from net product sales of Translarna and Emflaza. Translarna net product revenue was $191.9 million for the year ended December 31, 2020, an increase of $1.9 million, or 1%, compared to $190.0 million for the year ended December 31, 2019. These results were driven by broader uptake due to new patients in existing geographies, geographic expansion, and label updates. Emflaza net product revenue was $139.0 million for the year ended December 31, 2020, an increase of $38.0 million, or 38%, compared to $101.0 million for the year ended December 31, 2019. The increase was primarily due to the increase of new patient prescriptions and higher patient compliance.

Additionally, the Company confirms that in future filings it will revise its disclosure in its financial statements to provide disaggregated information by product pursuant to ASC 606-10-55-89 through 55-91.

The following paragraphs, with an updated footnote 13 “Revenue Recognition” for fiscal year ended December 31, 2020, reflects how PTC plans to enhance its disclosures in its future filings:

The Company views its operations and manages its business in one operating segment.

During the twelve months ended December 31, 2020, 2019, and 2018, net product sales in the United States were $139.0 million, $101.0 million, and $92.0 million respectively, consisting solely of sales of Emflaza, and net product sales outside the United States were $194.4 million, $190.3 million, and $171.0 million respectively, consisting of sales of Translarna, Tegsedi, and Waylivra. Translarna net product revenues made up $191.9 million, $190.0 million and $171.0 million of the net product sales outside the United States for the twelve months ended December 31, 2020, 2019 and 2018, respectively. For the twelve months ended December 31, 2020 and 2019, two of the Company’s distributors each accounted for over 10% of the Company’s net product sales. For the twelve months ended December 31, 2018, three of the Company’s distributors each accounted for over 10% of the Company’s net product sales.

* * *

Thank you for your consideration of our response to your comments. Should the Staff have additional questions or comments regarding the foregoing, please do not hesitate to contact the undersigned at (908) 912-9327.

Sincerely,
PTC Therapeutics, Inc.

Show Raw Text
CORRESP
1
filename1.htm

October 19, 2021

Mr. Gary
Newberry

Ms. Mary
Mast

Office of Life Sciences

United States Securities and Exchange Commission

Division of Corporation Finance

100 F Street, N.E.

Washington, DC 20549

    Re:

    PTC Therapeutics, Inc.

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

    Response dated September 23, 2021

    File No. 001-35969

Dear Mr. Newberry
and Ms. Mast:

This letter is submitted
on behalf of PTC Therapeutics, Inc. (the “Company” or “PTC”) in response to written comments of the Staff
(the “Staff”) of the Securities and Exchange Commission (the “Commission”) in the letter dated October 6,
2021 with respect to the Company’s response dated September 23, 2021 to the Staff’s letter dated August 26, 2021
with respect to PTC’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020, as filed with the Commission
on February 25, 2021 (the “2020 Form 10-K”). The Staff’s comment is reproduced below and the Company’s
corresponding response follows accordingly.

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

Management’s Discussion and Analysis

Results of Operations for the years
ended December 31, 2020 and 2019

Net product revenue, page 153

 1. We acknowledge your response to comment number 1, but respectively believe that disclosure of product
revenue by each significant product would be useful information for an investor, even if there are only two products. Please confirm that
you will provide disclosure in future filings. To the extent that one of the products is not generating significant product revenue, please
state that fact. Also, revise to provide disaggregated information by product in your financial statements pursuant to ASC 606-10-55-89
through 55-91 or tell us how you have met the disclosure requirements.

Response:
The Company confirms that in future filings it will disclose the product revenue of each significant product in the narrative
of the “Net product revenue” subsection of “Management’s Discussion and Analysis”.

The following paragraph, with an updated narrative
for the fiscal year ended December 31, 2020, reflects how PTC plans to enhance its disclosures in its future filings:

Net
product revenues. Net product revenue was $333.4 million for the year ended December 31, 2020, an increase of $42.1
million, or 14%, from net product revenue of $291.3 million for the year ended December 31, 2019, primarily stemming from net
product sales of Translarna and Emflaza. Translarna net product revenue was $191.9 million for the year ended December 31, 2020,
an increase of $1.9 million, or 1%, compared to $190.0 million for the year ended December 31, 2019. These results were
driven by broader uptake due to new patients in existing geographies, geographic expansion, and label updates. Emflaza net product
revenue was $139.0 million for the year ended December 31, 2020, an increase of $38.0 million, or 38%, compared to $101.0 million
for the year ended December 31, 2019. The increase was primarily due to the increase of
new patient prescriptions and higher patient compliance.

Additionally,
the Company confirms that in future filings it will revise its disclosure in its financial statements to provide disaggregated information
by product pursuant to ASC 606-10-55-89 through 55-91.

The following paragraphs, with an updated footnote
13 “Revenue Recognition” for fiscal year ended December 31, 2020, reflects how PTC plans to enhance its disclosures in
its future filings:

The Company views its operations and
manages its business in one operating segment.

During
the twelve months ended December 31, 2020, 2019, and 2018, net product sales in the United States were $139.0 million,
$101.0 million, and $92.0 million respectively, consisting solely of sales of Emflaza, and net product sales outside the United
States were $194.4 million, $190.3 million, and $171.0 million respectively, consisting of sales of Translarna, Tegsedi,
and Waylivra. Translarna net product revenues made up $191.9 million, $190.0 million and $171.0 million of the net product sales
outside the United States for the twelve months ended December 31, 2020, 2019 and 2018, respectively. For the twelve months ended
December 31, 2020 and 2019, two of the Company’s distributors each accounted for over 10% of the Company’s
net product sales. For the twelve months ended December 31, 2018, three of the Company’s distributors each accounted
for over 10% of the Company’s net product sales.

* * *

Thank
you for your consideration of our response to your comments. Should the Staff have additional questions or comments regarding the
foregoing, please do not hesitate to contact the undersigned at (908) 912-9327.

    Sincerely,

    PTC Therapeutics, Inc.

    /s/ Emily Hill

    Emily Hill

    Chief Financial Officer