PTC Therapeutics, Inc.

Ladies and gentlemen, thank you for standing by. Welcome to PTC Therapeutics Second Quarter 2025 Earnings Conference Call. All participants are in listen only mode. After the presentation, there will be the question and answer session. Today's call is being recorded. I would now like to turn the call over to Ellen Cavalleri, Head of Invest Relations. Please go ahead.

Good afternoon, and thank you for joining us to discuss PTC Therapeutics Second Quarter 2025 Corporate Update and Financial Results. I'm joined today by our Chief Executive Officer, Dr. Matthew Klein, our Chief Business Officer, Eric Powell, and our Chief Financial Officer, Pierre Gravier. Today's call will include forward-looking statements based on our current expectations. These statements are subject to certain risks and uncertainties, and actual results may differ materially. Please review the slide posted on our Investor Relations website in conjunction with the call, which contains information about our forward-looking statements and our most recent quarterly report on Form 10Q and annual report on Form 10K filed with the SEC, as well as our other SEC filings for a detailed description of applicable risks and uncertainties that could cause our actual performance and results to differ materially from those expressed or implied in these forward-looking statements. Additionally, we will disclose certain non-GAAP information during this call, information regarding our use of GAAP to non-GAAP financial measures, and the reconciliation of GAAP to non-GAAP are available in today's earnings release. I will now pass the call over to our CEO, Dr. Matthew Klein.

Thank you all for joining today. I'm pleased to share results from another strong quarter highlighted by the first approvals for suffice for the treatment of children and adults with PKU. We expect suffice to be the foundational product for PTC's sustainable growth and path to profitability. In the second quarter, we again had solid revenue performance with total revenue of 179 million, with continued contributions from our DMV franchise, including in Europe. Following the non-renewal of the Translarna Conditional Marketing Authorization, we have reached agreements with about half of European countries based on the unprecedented use of Article 117 to provide paid Translarna products. For the remainder of 2025, we expect to be able to maintain approximately 25% of European revenue from prior to authorization non-renewal. The highlight of the quarter was the EU approval of suffice in late June with a broad label inclusive of all disease subtypes and age groups. And last week, we announced FDA approval of suffice with similar broad labeling for patients age one month and above. Based on the strong suffice data package and the significant unmet need for PKU patients, suffice is positioned to become the new standard of care for children and adults living with PKU. As we have discussed, we believe the suffice revenue opportunity in the US exceeds one billion, and our global customer-facing teams are excited to bring the therapy to all those that could benefit. We initiated the European launch in Germany mid-July and are leveraging early access mechanisms in other European countries while formal pricing and reimbursement discussions proceed. In the US, we plan to ship the first commercial drug to patients within the next two weeks and look forward to a robust early launch. Eric will provide further details on the suffice launches shortly. Given the potential significant revenue opportunity for suffice, PTC has reached an agreement to purchase the annual global net sales payment obligation of 8 to 12% that was part of the acquisition of Sensa Pharmaceuticals in 2020. PTC will pay the participating Sensa rights holders approximately 225 million upfront and additional future sales milestones for approximately 90% of our net sales payment obligation. We view this transaction as a constructive use of our cash reserves given the expected value creation based on the transaction terms. Now with the FDA approval of suffice, we have two NDAs that remain under FDA review. For Veticranone and Tranwarna. For the Veticranone NDA for Phrygitux Taxia, a late cycle meeting was held in July. At that meeting, FDA shared that the application is still under active review and confirmed they did not plan to hold an advisory committee meeting. Turning to the PTC 518 for Vodoplam Huntington's disease program, following the positive phase two pivot HD study results, we continue to collaborate with Novartis to develop our next steps for Vodoplam and aim to meet with FDA in the fourth quarter to discuss the phase three trial study design and potential accelerated approval pathway. Finally, we remain in a very strong financial position, closing the quarter with approximately 1.99 billion in cash, allowing us to fully support all planned commercial and R&D initiatives, engage in strategic business development activities and achieve cashflow breakeven without the need for additional capital. I will now turn the call over to Eric to discuss our commercial performance and our Safiance Global Launch. Eric?