Moberg Pharma AB (publ) (MOB) Q3 2020 Earnings Call

Investor webinar replay

Replay transcript excerpt

Hello and welcome to the Mobag Pharma conference call. Throughout the call, all participants will be in listen-only mode and afterwards there will be a question and answer session. Just to remind you, this conference call is being recorded. Today I'm pleased to present the CEO, Anna Jung. Please begin your meeting. Thank you and hello. My name is Anna Jung and I'm the CEO of Mobag Pharma. I also have our VP of Finance, Mark Beveridge, with me on this call today. I'm happy to present our interim report for the fifth quarter since we had a prolonged year, July to September 2020. You can find the report on our web page and there you can also find a PowerPoint presentation that I will be using as the basis for this telephone meeting. So I will start on page three in that presentation with the brief introduction to mobile pharma. So we're a Swedish pharmaceutical company that based our products on drug delivery of known substances, which reduces time to market and development risk compared to traditional drug development. And our lead program is MOB15 against onychomycosis, nail fungus. the global sales potential of $250 to $500 million annually. And based on the outcome of the two P3 trials on more than 800 patients where we met their primary endpoints, we have sufficient data to file for registration in EU. We are thus targeting filing during next year, and based on average processing time for one and a half years, we expect approval early 2023. which would enable launch by the end of 2023. For the US, we will discuss with FDA, but we believe that one additional study is needed. It would be very similar to the North American study that we already completed, but with a shorter dosing regimen, enabling even stronger claims and higher complete surates. And when it comes to...