PTC Therapeutics Inc (PTCT) 2025Q1電話會議重點和逐字稿 - 財報狗 (2025)

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• Operator

• Ladies and gentlemen, thank you for standing by.

• Welcome to PTC Therapeutics first-quarter 2025 earnings conference call.

• (Operator Instructions) Today's conference is being recorded.

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• I would now like to turn the conference over to Ellen Cavaleri, Head of Investor Relations.

• Please go ahead.

• Ellen Cavaleri - Head of Investor Relations

• Good afternoon, and thank you for joining us to discuss PTC Therapeutics' first-quarter 2025 corporate update and financial results.

• I'm joined today by our Chief Executive Officer, Dr. Matthew Klein; our Chief Business Officer, Eric Pauwels; 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 10-Q and annual report on Form 10-K 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 a 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.

• Matthew Klein - President, Chief Executive Officer, Director

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• Thank you all for joining today.

• Following a year of outstanding execution across every part of the company, we're off to a great start in 2025.

• We achieved $190 million of revenue in the first quarter, made great progress on our preparations for the anticipated global launch of Sephience, and continue to work with regulatory authorities on our several pending approval applications.

• In addition, we closed the quarter with over $2 billion in cash, providing us the necessary resources to support all key commercial and R&D efforts as we continue to move towards becoming cash flow breakeven.

• Let me begin with our revenue performance.

• We closed the quarter with $190 million in total product and royalty revenue with continued strong contributions from the DMD franchise.

• With this revenue performance, we are narrowing our 2025 full-year revenue guidance to $650 million to $800 million.

• We expect to further narrow guidance pending regulatory actions and additional clarity on Emflaza performance for the remainder of 2025.

• We recently announced a positive CHMP opinion on the marketing authorization of Sephience with an expected broad label, including the full spectrum of PKU patients of all ages.

• As we await European Commission adoption of the opinion, which is expected in June, we are preparing for our European launch.

• In terms of launch sequence, we are prioritizing Germany and other countries where we can achieve early access through named patient programs.

• Eric will provide more details on the Sephience launch plan in Europe as well as in the US ahead of the anticipated FDA decision.

• In the first quarter, we shared updated data from the ongoing Sephience long-term studies that continue to support the ability of Sephience to address all key patient market segments and provide patients the ability to liberalize their diet.

• The most recent analysis of APHENITY long-term extension data demonstrates that 97% of participants in the Phe tolerance study were able to increase their dietary Phe intake with two-thirds of patients reaching or exceeding the recommended daily allowance of protein intake for an individual without PKU.

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