Theratechnologies reported Q1 results, with revenue increase of 86% (this because last year Q1 they only had EGRIFTA for lipostrophy in HIV patients and now they also have Trogarzo for multi-drug resistant HIV). This new Trogarzo drug did have a sequential increase of 44% Q1 2019 over Q4 2018.
But the big news for Thera came on Monday (yes, April Fool’s day) when they announced the results from a study conducted by Dr. Steve Grinspoon at the Massachusetts General Hospital and Harvard Medical School and the National Institutes of Health which concluded that tesamorelin (their EGRIFTA drug) significantly reduces liver fat in HIV patients with NAFLD. Tesamorelin achieved a 37% reduction in liver fat. 35% of patients in the tesamorelin group returned to liver fat values below 5%. Data analysis is ongoing and then Grinspoon will publish, but potential benefits for fibrosis prevention were seen in preliminary results.
On the conference call they outlined their immediate actions and plans to capitalize on these results. The background is that the current EGIFTA only has less than I think 4 more years patent protection in the USA. But they have been developing other formulations of EGRIFTA which would have full-term patent protection, and even the current formulation could receive patent protection in Europe for 10 years.
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They’re hiring 2 additional medical science liasons (adding to current 6) as these people can talk to doctors and key opinion leaders about using EGRIFTA for HIV with NASH-related liver problems (sales reps can’t as it’s not currently on the label).
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They will try to expand the label for HIV/NASH. The prevalence of NASH in HIV patients is high so this is an opportunity.
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They will look at filing in Europe for HIV/NASH.
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They will look to go outside the HIV NASH market, probably with their F8 formulation of EGRIFTA which already has patent protection to 2033.
So that’s the main takeaway. Will the analysts and the market see this as a viable NASH drug? Or will they view it as a short-term boost for off-label scripts in the States but patent protection looking iffy so no big deal?
I’m in, fwiw.
I don’t know if this is really a stock for Saul’s board. It’s more of a story stock, or a hidden gem or a bit of a turnaround. But growth is high. Anyway I thought I should post this as I’ve posted a few on this one since 2016 and mentioned the NASH study last year.
A Seeking Alpha service Liver Therapy Forum is jazzed on Thera but it is a subscription service. Still posts sometimes appear on the free site from her and I bet they’ll be one on the study results soon. A link to one of her subscriber-only articles:
https://seekingalpha.com/article/4250263-theratechnologies-n…
John