Item 2.02 Results of Operations and Financial Condition.
On January 9, 2023, PTC Therapeutics, Inc. (the "Company") issued a press
release (the "press release") announcing certain preliminary (unaudited)
financial information for its fiscal year ending December 31, 2022, including
that the Company expects to report (i) total unaudited net revenue of
approximately $710 million, (ii) total unaudited net product revenue of
approximately $535 million, (iii) net product revenue for Translarna™ (ataluren)
of approximately $289 million and net product revenue for Emflaza® (deflazacort)
of approximately $218 million and (iv) collaboration and royalty revenue
associated with Evrysdi of approximately $175 million. Final results are subject
to completion of the Company's year-end audit.
Item 7.01. Regulation FD Disclosure.
On January 9, 2023, the Company also announced financial guidance for its fiscal
year ending December 31, 2023 in the press release, including that the Company
anticipates (i) full year total revenues to be between $940 million and $1.0
billion (ii) full year net product revenues for the Duchenne muscular dystrophy
franchise to be between $545 and $565 million (iii) GAAP R&D and SG&A expense
for the full year 2023 to be between $1.01 and $1.06 billion with non-GAAP R&D
and SG&A expense for the full year 2023 to be between $890 and $940 million,
excluding estimated non-cash, stock-based compensation expense of approximately
$120 million and (iv) up to $80 million of one-time payments upon achievement of
potential clinical and regulatory success-based milestones from previous
acquisition.
The Company announced that on Monday, January 9, 2023 at 10:30 am EST at the
41st Annual J.P. Morgan Healthcare Conference, the Company will provide an
update on 2022 accomplishments and highlight upcoming 2023 potential
value-creating milestones. The Company will also present its preliminary 2022
financial results and 2023 financial guidance. The presentation will be webcast
live on the Events and Presentations page under the Investors section of the
Company's website.
A copy of the press release is attached to this Current Report on Form 8-K as
Exhibit 99.1 and is incorporated by reference into this Item 7.01.
This Current Report on Form 8-K and Exhibits 99.1 and 99.2 include a
forward-looking financial measure that was not prepared in accordance with
accounting principles generally accepted in the United States (GAAP), non-GAAP
R&D and SG&A expenses (which excludes non-cash stock-based compensation
expense). Management uses this measure when assessing and identifying
operational trends and, in management's opinion, this non-GAAP measure is useful
to investors and other users of its financial statements by providing greater
transparency into the historical and projected operating performance of the
Company and the Company's future outlook. Non-GAAP financial measures are not an
alternative for financial measures prepared in accordance with GAAP.
The information set forth in or incorporated by reference into Item 2.02 or this
Item 7.01, including Exhibits 99.1 and 99.2, shall not be deemed "filed" for
purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the
"Exchange Act"), or otherwise subject to the liabilities of that section, nor
shall it be deemed incorporated by reference in any filing under the Securities
Act of 1933, as amended, or the Exchange Act, except as expressly set forth by
specific reference in such a filing. All website addresses given in this Current
Report on Form 8-K or incorporated herein by reference are for information only
and are not intended to be an active link or to incorporate any website
information into this Current Report on Form 8-K.
Forward Looking Statements: All statements, other than those of historical fact,
contained in this Current Report on Form 8-K, are forward-looking statements,
including reporting expectations with respect to financial information for
fiscal year 2022 and financial guidance for fiscal year 2023. The Company's
actual results, performance or achievements could differ materially from those
expressed or implied by forward-looking statements it makes as a result of a
variety of risks and uncertainties, including those related to the preliminary
nature of the Company's 2022 financial information, which is subject to
completion of the Company's year-end audit; the assumptions underlying the
Company's financial guidance for 2023; and the factors discussed in the "Risk
Factors" section of the Company's Annual Report on Form 10-K for the year ended
December 31, 2021 as well as any updates to these risk factors filed from time
to time in the Company's other filings with the Securities and Exchange
Commission. You are urged to carefully consider all such factors. The
forward-looking statements contained herein and the exhibits hereto represent
the Company's views only as of the date of this Current Report on Form 8-K and
the Company does not undertake or plan to update or revise any such
forward-looking statements to reflect actual results or changes in plans,
prospects, assumptions, estimates or projections, or other circumstances
occurring after the date of this Current Report on Form 8-K except as required
by law.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. Description
Press Release, dated January 9, 2023 issued by PTC Therapeutics,
99.1 Inc.
Corporate Presentation - 41st Annual J.P. Morgan Healthcare
99.2 Conference
The cover page from this Current Report on Form 8-K, formatted in
104 Inline XBRL© Edgar Online, source Glimpses
PTC THERAPEUTICS, INC. 
