<SEC-DOCUMENT>0001104659-21-127548.txt : 20211126
<SEC-HEADER>0001104659-21-127548.hdr.sgml : 20211126
<ACCEPTANCE-DATETIME>20211019154815
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0001104659-21-127548
CONFORMED SUBMISSION TYPE:	CORRESP
PUBLIC DOCUMENT COUNT:		2
FILED AS OF DATE:		20211019

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			PTC THERAPEUTICS, INC.
		CENTRAL INDEX KEY:			0001070081
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				043416587
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		CORRESP

	BUSINESS ADDRESS:	
		STREET 1:		100 CORPORATE COURT
		CITY:			SOUTH PLAINFIELD
		STATE:			NJ
		ZIP:			07080-2449
		BUSINESS PHONE:		9082227000

	MAIL ADDRESS:	
		STREET 1:		100 CORPORATE COURT
		CITY:			SOUTH PLAINFIELD
		STATE:			NJ
		ZIP:			07080-2449

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	PTC THERAPEUTICS INC
		DATE OF NAME CHANGE:	19980909
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><IMG SRC="tm2130545d1_correspimg001.jpg" ALT="" STYLE="height: 124px; width: 459px"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">October&nbsp;19, 2021</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif">Mr.&nbsp;</FONT>Gary
Newberry</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif">Ms.&nbsp;</FONT>Mary
Mast</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">Office of Life Sciences</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">United States Securities and Exchange Commission</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">Division of Corporation Finance</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">100 F Street, N.E.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">Washington, DC 20549</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; background-color: white; border-collapse: collapse">
  <TR>
    <TD STYLE="vertical-align: top; font-size: 10pt; width: 4%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Re:</B></FONT></TD>
    <TD STYLE="vertical-align: bottom; width: 96%">
    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>PTC Therapeutics,&nbsp;Inc.</B></P>
    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Form&nbsp;10-K for the Fiscal Year Ended December&nbsp;31, 2020</B></P>
    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Response dated September&nbsp;23, 2021</B></P>
    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>File No.&nbsp;001-35969</B></P></TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white">Dear Mr.&nbsp;Newberry
and Ms.&nbsp;Mast:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white">This letter is submitted
on behalf of PTC Therapeutics,&nbsp;Inc. (the &ldquo;Company&rdquo; or &ldquo;PTC&rdquo;) in response to written comments of the Staff
(the &ldquo;Staff&rdquo;) of the Securities and Exchange Commission (the &ldquo;Commission&rdquo;) in the letter dated October&nbsp;6,
2021 with respect to the Company&rsquo;s response dated September&nbsp;23, 2021 to the Staff&rsquo;s letter dated August&nbsp;26, 2021
with respect to PTC&rsquo;s Annual Report on Form&nbsp;10-K for the fiscal year ended December&nbsp;31, 2020, as filed with the Commission
on February&nbsp;25, 2021 (the &ldquo;2020 Form&nbsp;10-K&rdquo;). The Staff&rsquo;s comment is reproduced below and the Company&rsquo;s
corresponding response follows accordingly.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I><U>Form&nbsp;10-K for the Fiscal Year Ended December&nbsp;31,
2020</U></I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I><U>Management&rsquo;s Discussion and Analysis</U></I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I><U>Results of Operations for the years
ended December&nbsp;31, 2020 and 2019</U></I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I><U>Net product revenue, page&nbsp;153</U></I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in">1.</TD><TD STYLE="text-align: justify"><B><I>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.</I></B></TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>Response:
</B></FONT>The Company confirms that in future filings it will disclose the product revenue of each significant product in the narrative
of the &ldquo;Net product revenue&rdquo; subsection of &ldquo;Management&rsquo;s Discussion and Analysis&rdquo;.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><U>The following paragraph, with an updated narrative
for the fiscal year ended December&nbsp;31, 2020, reflects how PTC plans to enhance its disclosures in its future filings:</U></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif"><I>Net
product revenues.</I></FONT> Net product revenue was $333.4 million for the year ended December&nbsp;31,&nbsp;2020, an increase of $42.1
million, or 14%, from net product revenue of $291.3 million for the year ended December&nbsp;31,&nbsp;2019, primarily stemming from net
product sales of Translarna and Emflaza. Translarna net product revenue was $191.9 million for the year ended December&nbsp;31,&nbsp;2020,
an increase of $1.9 million, or 1%, compared to $190.0 million for the year ended December&nbsp;31,&nbsp;2019. These results <FONT STYLE="background-color: white">were
driven by broader uptake due to new patients in existing geographies, geographic expansion, and label updates</FONT>. Emflaza net product
revenue was $139.0 million for the year ended December&nbsp;31,&nbsp;2020, an increase of $38.0 million, or 38%, compared to $101.0 million
for the year ended December&nbsp;31,&nbsp;2019. <FONT STYLE="background-color: white">The increase was primarily due to the increase of
new patient prescriptions and higher patient compliance.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="background-color: white">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.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><U>The following paragraphs, with an updated footnote
13 &ldquo;Revenue Recognition&rdquo; for fiscal year ended December&nbsp;31, 2020, reflects how PTC plans to enhance its disclosures in
its future filings:</U></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify">The Company views its operations and
manages its business in one operating segment.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">During
the twelve&nbsp;months ended December&nbsp;31, 2020, 2019, and 2018, net product sales in the United States were $139.0&nbsp;million,
$101.0&nbsp;million, and $92.0&nbsp;million respectively, consisting solely of sales of Emflaza, and net product sales outside the United
States were $194.4&nbsp;million, $190.3&nbsp;million, and $171.0&nbsp;million respectively, consisting of sales of Translarna, Tegsedi,
and Waylivra. </FONT>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&nbsp;31, 2020, 2019 and 2018, respectively. For the twelve months ended
December&nbsp;31, 2020 and 2019,&nbsp;two&nbsp;of the Company&rsquo;s distributors each accounted for over&nbsp;10% of the Company&rsquo;s
net product sales. For the twelve months ended December&nbsp;31, 2018,&nbsp;three&nbsp;of the Company&rsquo;s distributors each accounted
for over&nbsp;10% of the Company&rsquo;s net product sales.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">* * *</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif">Thank
you for your consideration of our response to your comments.</FONT> Should the Staff have additional questions or comments regarding the
foregoing, please do not hesitate to contact the undersigned at (908) 912-9327.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
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    <TD STYLE="width: 50%">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; width: 50%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Sincerely,</FONT></TD></TR>
  <TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD STYLE="font-size: 10pt"><B>PTC Therapeutics,&nbsp;Inc.</B></TD></TR>
  <TR>
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
  <TR>
    <TD>&nbsp;</TD>
    <TD STYLE="border-bottom: Black 1pt solid">/s/ Emily Hill</TD></TR>
  <TR>
    <TD>&nbsp;</TD>
    <TD>Emily Hill</TD></TR>
  <TR>
    <TD>&nbsp;</TD>
    <TD STYLE="font-size: 10pt">Chief Financial Officer</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
