PTC THERAPEUTICS, INC. (NASDAQ:PTCT) Files An 8-K Results of Operations and Financial Condition

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PTC THERAPEUTICS, INC. (NASDAQ:PTCT) Files An 8-K Results of Operations and Financial Condition
Item 2.02. Results of Operations and Financial Condition.

On January 8, 2018, PTC Therapeutics, Inc. (the “Company”) issued a press release (the “press release”) announcing certain preliminary (unaudited) financial information for its fourth quarter and fiscal year ending December 31, 2017, including that the Company expects to report (i) TranslarnaTM(ataluren) net product revenue for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD) of approximately $145 million; (ii) EMFLAZA™ (deflazacort) net product revenue for the treatment of Duchenne muscular dystrophy (DMD) of approximately $29million; and (iii) ending cash and cash equivalents of approximately $191 million. 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, 2018 in the press release, including that the Company anticipates (i) full-yearnet productrevenuesto be between $260 and $295 million, with Translarnanet product revenuefor the full year 2018 to bebetween$170and $185million and EMFLAZA net product revenueforthe full year2018 to be between $90 and $110 million and (ii) GAAPR&D and SG&Aexpense for the full year 2018 to be between $280 and $290million with non-GAAPR&D and SG&Aexpensefor the full year 2018 to be between $250 and $260million, excluding estimated non-cash, stock-based compensation expense of approximately $30 million.

This Current Report on Form 8-K and Exhibit 99.1 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 stock-based compensation expense). Management uses this measure to assess its operations 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 expected operating performance at 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 Exhibit 99.1, 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 preliminary (unaudited) financial information for 2017 and financial guidance for 2018. 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 2017 financial information, which is subject to completion of the Company's year-end audit; the assumptions underlying the Company's financial guidance for 2018; and the factors discussed in the “Risk Factors” section of the Company's most recent Quarterly Report on Form 10-Q as well as any updates to these risk factors filed from time to time in the Company's other filings with theSEC. You are urged to carefully consider all such factors. The forward-looking statements contained herein 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

99.1

Press Release, dated January 8, 2018


PTC THERAPEUTICS, INC. Exhibit
EX-99.1 2 ex991pressrelease010818.htm EXHIBIT 99.1 Exhibit PTC Therapeutics Provides Corporate Update and Outlines 2018 Strategic Priorities– Preliminary 2017 unaudited total revenues of approximately $195M,…
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About PTC THERAPEUTICS, INC. (NASDAQ:PTCT)

PTC Therapeutics, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of orally administered, small molecule therapeutics that focus on post-transcriptional control processes. The Company’s lead product, Translarna (ataluren), is used for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD) in ambulatory patients with age of over five years and older. Its programs include Translarna for nonsense mutation cystic fibrosis (nmCF), Translarna for mucopolysaccharidosis type I caused by nonsense mutation (nmMPS I), Translarna for nonsense mutation aniridia, Translarna for nonsense mutation Dravet syndrome/CDKL5, Spinal muscular atrophy (SMA) in collaboration with Spinal Muscular Atrophy Foundation (SMA Foundation) and F. Hoffman-La Roche Ltd and Hoffman- La Roche Inc. (collectively Roche), and Cancer stem cell program (PTC596). It has two compounds in clinical development within the SMA program: RG7800 and RG7916.