Item 2.02. Results of Operations and Financial Condition.
On January 11, 2021, 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, 2020, including
that the Company expects to report (i) total unaudited net product revenue of
approximately $333 million, (ii) net product revenue for Translarna™ (ataluren)
of approximately $192 million, with approximately $69 million in revenue in the
fourth quarter of 2020, and net product revenue for Emflaza® (deflazacort) of
approximately $139 million, with approximately $37 million in revenue in the
fourth quarter of 2020, (iii) $42.5 million in revenue associated with Evrysdi™
(risdiplam) milestones and (iv) ending cash and cash equivalents of
approximately $1.1 billion. Final results are subject to completion of the
Company's year-end audit.
Item 7.01. Regulation FD Disclosure.
The Company also announced financial guidance for its fiscal year ending
December 31, 2021 in the press release, including that the Company anticipates
(i) full-year net product revenues for the Duchenne muscular dystrophy franchise
to be between $355 and $375 million and (ii) GAAP R&D and SG&A expense for the
full year 2021 to be between $825 and $855 million with non-GAAP R&D and SG&A
expense for the full year 2021 to be between $725 and $755 million, excluding
estimated non-cash, stock-based compensation expense of approximately $100
million.
The Company announced that on Monday, January 11, 2021 at 7:30 am EST at the
39th Annual J.P. Morgan Healthcare Conference, the Company will present its 2021
strategic priorities, preliminary 2020 financial results, and 2021 financial
guidance. The presentation will be webcast live on the Events and Presentations
page under the Investors section of the Company's website.
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 SGA 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 PTC and the Company's
future outlook. Non-GAAP financial measures are not an alternative for financial
measures prepared in accordance with GAAP.
The information in this Current Report on Form 8-K, 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.
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 2020 and financial guidance for fiscal year 2021. 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 2020 financial information, which is subject to
completion of the Company's year-end audit; the assumptions underlying the
Company's financial guidance for 2021; 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, 2019, Quarterly Reports on Form 10-Q for the periods ended March
31, 2020, June 30, 2020 and September 30, 2020 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. 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 Report.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. Description
Press Release, dated January 11, 2021 issued by PTC
99.1 Therapeutics, Inc.
Corporate Presentation - 39th Annual J.P. Morgan Healthcare
99.2 Conference
The cover page from this Current Report on Form 8-K, formatted in
104 Inline XBRL
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