Profound Medical (Profound Medical Stock Quote, Chart TSX:PRN) is getting a huge target raise from Mackie Research analyst André Uddin on the back of encouraging clinical trial results for its Tulsa-Pro device for the ablation of localized prostate cancer.
In an update Friday, the analyst maintained his “Speculative Buy” rating with the new target of $2.15 (previously $1.10), which represented a projected return of 159 per cent at the time of publication.
On Thursday Profound announced results from its TACT trial for the Tulsa-Pro with 115 subjects with localized prostate cancer, with the efficacy endpoint being the proportion of subjects achieving more than 75 per cent reduction in Prostate-Specific Antigen (PSA) after 12 months of treatment. The pre-defined goal was 50 per cent of the subjects and the results showed that 95.7 per cent of the subjects achieved the PSA reduction endpoint, with the median PSA reduction being 94.9 per cent.
“We are pleased to announce these positive top line results from TACT contemporaneously with the abstract being published online by the AUA,” said Arun Menawat, Profound’s CEO, in a press release. “We look forward to the presentation of the full TACT data at AUA 2019, and plan to file the 510(k) application with the FDA for TULSA-PRO [(R)] by the end of the second quarter.”
Uddin says that he is confident that the Tulsa-Pro will get FDA approval by Q4 of this year, with a US launch to follow in early 2020.
“We expect PRN to shift its focus from Europe to the US once Tulsa-Pro is launched in the latter. We also expect the TACT results to help Tulsa-Pro garner decent market share in the US – beating the competitors (such as HIFU),” says Uddin. “We are significantly raising our US sales estimates while lowering our European sales outlook across the board. We are increasing global sales estimates for Sonalleve in outer years.”
Uddin estimates that Profound Medical will generate fiscal 2019 revenue of $5.8 million and fully diluted EPS of negative $0.19 per share, followed by fiscal 2020 revenue of $23.0 million and fully diluted EPS of negative $0.02 per share, followed again by fiscal 2021 revenue of $62.3 million and fully diluted EPS of $0.03 per share.