Item 2.02. Results of Operations and Financial Condition.
On January 12, 2026, 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, 2025, including that the Company expects to report (i) total unaudited net product and royalty revenue of approximately $823.4 million, (ii) total unaudited net product revenue of approximately $587.8 million, and (iii) unaudited net product revenue for Sephience™ (sepiapterin) of approximately $112.1 million. Final results are subject to completion of the Company’s year-end audit.
Item 7.01. Regulation FD Disclosure.
On January 12, 2026, the Company also announced financial guidance for its fiscal year ending December 31, 2026 in the press release, including that the Company anticipates (i) full year total product revenues of $700 million to $800 million, excluding Evrysdi® (risdiplam) royalty revenue and collaboration revenue and (ii) GAAP R&D and SG&A expense for the full year 2026 of $775 million to $815 million with non-GAAP R&D and SG&A expense for the full year 2026 of $680 million to $720 million, excluding estimated non-cash, stock-based compensation expense of $95 million.
The Company announced that on Monday, January 12, 2026 at 12:00 p.m. EST at the 44th Annual J.P. Morgan Healthcare Conference (the “Conference”), the Company will provide an update on 2025 accomplishments and highlight upcoming 2026 potential value-creating milestones. The Company will also present its preliminary 2025 unaudited financial results and 2026 financial guidance. The presentation will be webcast live on the Events and Presentations page under the Investors section of the Company’s website. Following the completion of the Conference, the Company will enter an investor quiet period until it provides its next corporate update.
A copy of the press release and the slide presentation are attached to this Current Report on Form 8-K as Exhibits 99.1 and 99.2 and are 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 2025 and financial guidance for fiscal year 2026. 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 2025 financial information, which is subject to completion of the Company's year-end audit; the assumptions underlying the Company's financial guidance for 2026; 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, 2024, 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.
