PTC Therapeutics Q2 2020 Earnings Report
Key Takeaways
PTC Therapeutics reported total net product revenues of $75.2 million for the second quarter of 2020. The company's Duchenne muscular dystrophy franchise performed strongly, with Emflaza increasing 30% year-over-year. PTC is advancing its pipeline and platforms with the acquisition of a late-stage asset for phenylketonuria (PKU).
Emflaza had a strong second quarter with a 30% year-over-year net product revenue increase.
PTC initiated PTC299 trial in COVID-19 in multiple countries.
A clinical trial was initiated with PTC857, identified from Bio-e platform.
PTC has greater than $1B in cash to accelerate pipeline growth.
PTC Therapeutics
PTC Therapeutics
PTC Therapeutics Revenue by Segment
Forward Guidance
This press release contains forward-looking statements regarding PTC's future expectations, plans and prospects, including the expected timing of clinical trials and studies, availability of data, regulatory submissions and responses, expectations with respect to PTC's gene therapy platform, advancement of PTC's joint collaboration program in SMA, PTC's expected use of proceeds from the agreement with Royalty Pharma, PTC's expectations with respect to the licensing, regulatory submissions and commercialization of its products and product candidates, the timing with respect to orders for PTC’s products, expectations with respect to the impacts of the COVID-19 pandemic and related response measures, PTC's strategy, future operations, future financial position, future revenues, projected costs, and the objectives of management.
Positive Outlook
- PTC is focused on the discovery, development and commercialization of clinically differentiated medicines.
- PTC's ability to globally commercialize products drives investment in a robust and diversified pipeline.
- PTC aims to provide access to best-in-class treatments for patients with unmet medical needs.
- The Huntington disease program remains on track for the initiation of first-in-human studies in 2020.
- PTC expects to initiate submission of the biologics license application (BLA) to the U.S. FDA in the second half of 2020 for its AADCd gene therapy program.
Challenges Ahead
- There are significant risks in the development, regulatory approval and commercialization of new products.
- COVID-19 related delays are impacting the final opinion from the CHMP on the MAA for the AADCd program.
- The final study muscle biopsies have not yet been collected from 8 remaining boys in the Translarna (ataluren) dystrophin study due to COVID-19.
- PTC's actual results could differ materially from those expressed or implied by forward-looking statements.
- There are no guarantees that any product will receive or maintain regulatory approval in any territory.