PTC Therapeutics reported Q3 2020 financial results with a 66% year-over-year increase in total revenue and highlighted the progress of Evrysdi and the Duchenne muscular dystrophy franchise.
Key Takeaways
PTC Therapeutics reported a strong third quarter with total revenue of $118.4 million, a 66% increase year-over-year. The growth was driven by the U.S. launch of Evrysdi and continued growth in the Duchenne muscular dystrophy franchise. The company also initiated a registration-directed trial for mitochondrial epilepsy.
Evrysdi made rapid progress with multiple international approvals and a strong U.S. launch.
Total net revenue reached $118.4 million, a 66% year-over-year increase.
Total net product revenue was $82.7 million, a 16% year-over-year increase.
A registration-directed trial with vatiquinone (PTC743) for mitochondrial epilepsy was initiated.
The press release contains forward-looking statements regarding PTC's future expectations, plans, and prospects, including clinical trials, regulatory submissions, commercialization, and financial performance. These statements are subject to risks and uncertainties.
Positive Outlook
Future expectations, plans and prospects for PTC, including with respect to the expected timing of clinical trials and studies, availability of data, regulatory submissions and responses and other matters
Expectations with respect to PTC's gene therapy platform, including any potential regulatory submissions and manufacturing capabilities
Advancement of PTC's joint collaboration program in SMA, including any potential regulatory submissions, commercialization or royalty or milestone payments
PTC's expectations with respect to the licensing, regulatory submissions and commercialization of its products and product candidates
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
Challenges Ahead
The outcome of pricing, coverage and reimbursement negotiations with third party payors for PTC's products or product candidates that PTC commercializes or may commercialize in the future
Historical Earnings Impact
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Expectations with respect to PTC's gene therapy platform, including any potential regulatory submissions and potential approvals, manufacturing capabilities and the potential financial impact and benefits of its leased biologics manufacturing facility and the potential achievement of development, regulatory and sales milestones and contingent payments that PTC may be obligated to make
PTC's ability to complete a dystrophin study necessary to support a re-submission of its Translarna NDA for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD) to the FDA, and PTC's ability to perform any necessary additional clinical trials, non-clinical studies, and CMC assessments or analyses at significant cost
Expectations with respect to the COVID-19 pandemic and related response measures and their effects on PTC's business, operations, clinical trials, potential regulatory submissions and approvals, and PTC's collaborators, contract research organizations, suppliers and manufacturers
The sufficiency of PTC's cash resources and its ability to obtain adequate financing in the future for its foreseeable and unforeseeable operating expenses and capital expenditures