PTC THERAPEUTICS, INC. (NASDAQ:PTCT) Files An 8-K Results of Operations and Financial ConditionItem 2.02. Results of Operations and Financial Condition.
PTC THERAPEUTICS, INC. (NASDAQ:PTCT) Files An 8-K Results of Operations and Financial Condition
On January 9, 2017, 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, 2016, including that the Company expects to report (i) TranslarnaTM>(ataluren) net sales for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD) of approximately $81 million and (ii) ending cash and cash equivalents of approximately $230 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, 2017 in the press release, including that the Company expects (i) ex-U.S. Translarna nmDMD net sales of between $105 and $125 million, assuming current exchange rates; (ii) non-GAAP operating expenses $190 and $200 million, excluding estimated non-cash stock-based compensation expense of approximately $35 million, for total GAAP operating expenses of approximately $225 to $235 million; and (iii) ending cash and cash equivalents of approximately $160 million.
The Company announced that on Wednesday, January 11th at 7:30 am PT at the 35th Annual J.P. Morgan Healthcare Conference (the “Conference”), the Company will present its 2017 strategic priorities, preliminary 2016 financial results, and 2017 financial guidance. The presentation will be webcast live and the accompanying slide deck has been posted on the Events and Presentations page under the Investors section of the Company’s website. A copy of the slide deck, which the Company intends to utilize in various meetings at the Conference, is also attached as Exhibit 99.2.
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 operating 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 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 preliminary (unaudited) financial information for 2016 and financial guidance for 2017. 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 2016 financial information, which is subject to completion of the Company’s year-end audit; the assumptions underlying the Company’s financial guidance for 2017; 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 the SEC. 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:
99.1 Press Release dated January 9, 2017
99.2 Corporate Presentation – 35th Annual J.P. Morgan Healthcare Conference
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. PTC THERAPEUTICS, INC. (NASDAQ:PTCT) Recent Trading Information
PTC THERAPEUTICS, INC. (NASDAQ:PTCT) closed its last trading session up +0.87 at 13.82 with 966,292 shares trading hands.
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. PTC THERAPEUTICS, INC. (NASDAQ:PTCT) Recent Trading Information
PTC THERAPEUTICS, INC. (NASDAQ:PTCT) closed its last trading session up +0.87 at 13.82 with 966,292 shares trading hands.