The conference call recording has now been published on Moberg’s website: Sidan kunde inte hittas | Moberg Pharma
In my opinion, it didn’t provide much additional information:
-They are not publishing patient numbers or percentages because they want to “protect” the blinded data (I interpret this to mean that preliminary information about the results shouldn’t influence the results themselves or the analysis of the results).
-The data came as a surprise to the company as well, apparently in connection with some other discussion.
-The data is “disappointing” according to the CEO, but even they don’t have more detailed data yet (e.g., information on mycological efficacy), and no conclusions regarding the US launch can be made yet.
-It does not affect the launch in the EU region. In the EU, getting new terbinafine suppliers approved has a greater impact, and new marketing authorizations in the EU cannot (??) be applied for until there are new suppliers.
-It likely won’t affect launches in Israel, the UK, or Canada either. In Japan, a separate study is apparently needed regardless of the current study. If I recall correctly, the Japanese partner ended the collaboration even before the EU marketing authorizations.
-Market share is now 40% in Sweden (I interpret this as referring to topical treatments) and it is the market leader. Based on this, I would assume that the US study won’t have much of an impact on those countries where Terclara will be sold over-the-counter.
-The launch in EU countries might be delayed until 2026. I thought the explanation for this was very strange: that it needs to be brought to market early in the year when demand is at its peak. I don’t understand the logic here. For example, regarding Southern Europe, it probably doesn’t matter much if the product is released as late as autumn. But increasing sales in Europe seems slow. There is also a delay of about 6 months from pharmacies (they take on new products for sale 2-3 times a year).
Perhaps the share price reaction is a bit of an overreaction (-61%), but on the other hand, the uncertainty will continue until December when the final data is published. Even if marketing authorization is not obtained for the US, Terclara will be sold at least in the EU region.