PTC Therapeutics Q2 2021 Earnings Report
Key Takeaways
PTC Therapeutics reported a strong second quarter in 2021, with a 55% increase in total revenue compared to the same period in 2020, reaching $116.7 million. The Duchenne muscular dystrophy (DMD) franchise was a key driver, with $102 million in net product revenue, a 36% increase year-over-year. The company also raised its 2021 DMD franchise revenue guidance to $370-$390 million. Additionally, the company has multiple ongoing clinical trials, three of which are registration-directed clinical studies.
Total revenue reached $116.7 million, a 55% increase from Q2 2020.
DMD franchise revenue was $102 million, representing 36% growth year-over-year.
Translarna revenue grew due to patient base expansion and geographic reach.
Emflaza revenue increased due to new prescriptions and high compliance.
PTC Therapeutics
PTC Therapeutics
PTC Therapeutics Revenue by Segment
Forward Guidance
PTC Therapeutics anticipates net product revenues for the DMD franchise for the full year 2021 to be between $370 and $390 million and continues to anticipate GAAP R&D and SG&A expense for the full year 2021 to be between $825 and $855 million.
Positive Outlook
- Net product revenues for the DMD franchise for the full year 2021 to be between $370 and $390 million.
- Continue to anticipate GAAP R&D and SG&A expense for the full year 2021 to be between $825 and $855 million.
- Continue to anticipate Non-GAAP R&D and SG&A expense for the full year 2021 to be between $725 and $755 million, excluding estimated non-cash, stock-based compensation expense of $100 million.
- Progress across robust clinical pipeline with 3 ongoing registration-directed trials
- Evrysdi received approval from the Ministry of Health Labor and Welfare in Japan in June 2021.
Challenges Ahead
- The Committee for Medicinal Products for Human Use (CHMP) imposed a clock stop in the aromatic L-amino acid decarboxylase deficiency (AADC-d) review process to allow for completion of its pre-approval inspections.
- This process is still ongoing and therefore the CHMP opinion is now expected in the fourth quarter of 2021.
- There are significant risks in the development, regulatory approval and commercialization of new products.
- significant risks in the development, regulatory approval and commercialization of new products.
- Net loss was $118.4 million for the second quarter of 2021, compared to net loss of $181.4 million for the second quarter of 2020.
Revenue & Expenses
Visualization of income flow from segment revenue to net income