I've been doing a deep dive on Botanix and have had a thorough look at Argonauts most recent research report which provides some optimistic and interesting information about the phase 2 trial results and other FDA approved treatment studies. The report itself can be found here:
http://www.botanixpharma.com/wp-content/uploads/14112019-Botanix-Acne-Results-Deep-Dive-002.pdf.
I want to highlight the following table which shows the primary endpoint results from various treatment phase 3 and 4 studies.
As you can see, the vehicle arm results for Aczone and Amzeeq are significantly high (43-46%) and even higher than the vehicle arm results for Botanix. Argonaut makes the argument that despite these high vehicle results they stilled carried on to become successful treatments with Aczone having peak revenue of $300m.
However I'd like to make two observations here. Both Amzeeq and Aczone have much higher efficacy rates (>50%) and Aczone still manages to achieve a separation of 14% from the vehicle. Amzeeq has a poor safety profile with adverse events of 25% so we can ignore it for now but Aczone not only achieves a lesion reduction of more than 25% than that of BTX 1503 but it also has an even lower adverse event rate (although I admit both 1.1% and 0.4% is negligible here).
This makes me think the reason the market was so disappointed in the phase 2 results was not just the poor separation between the vehicle but also the absolute rate of lesion reductions not being markedly greater than the phase 1 results which was just 4 weeks and lower than products already in the market.
I'd like to get other peoples thoughts on my observations here.
I'd also like to point out that I'm currently a holder and am cautiously optimistic about BTX 1204 phase 2 trial results being successful and boosting the share price back to the teens. HOWEVER, again I'm a bit worried that the trials are again being done in the US, most likely using similar suppliers as they did for BTX 1503 as it was conducted during a similar period. Also, a bit worried about the BTX 1503 phase 2 completion meeting with the FDA and if they'll allow phase 3 with the poor separation and efficacy results not being significantly better than what's already in the market.
(20min delay)