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| So I think, first and foremost, I think value we add when we look at a new program, I think the ability to be efficient, thoughtful and creative on development strategy, selection of indication and then just strong at execution, the ability to move fast, I think is also something we are really proud of |
| So a really tremendous set of data here that continues to support what we think is a really big opportunity in AD and notably, continue to have a clean safety profile with mild to moderate AEs, nothing sort of remarkable and a very low discontinuation rate due to adverse events |
| And also, we've shown data from our Phase 2 study in Graves’ disease that meaningfully exceeded our expectations |
| We remain the bestselling branded topical in psoriasis as we have been since the very beginning of our launch |
| And we see tremendous opportunity for a broad development strategy maximizing that unique set of competitive positioning across disease states |
| We are very proud of the extent to which we stand out for being included on this list at all, given the amount of data we generated, and at a -- obviously, significantly lower generally order of magnitude, lower cost, which just gets to the model of capital efficiency with which we bring programs in and which we develop them |
| And we're excited to continue to do that in our strong capital position |
| And we are excited for our product profile, which we think bluntly is even more differentiated in AD even in psoriasis |
| Our revenue continues to grow reasonably nicely |
| We hope to continue to accelerate revenue growth in psoriasis |
| We've done -- we think quite good job at late stage development for programs that we were happy with the choice of indication |
| It depends on our desires, but also the desires of some of our concentrated shareholders who in many cases are happy holders and frankly, believe what we believe, which is that our stock is meaningfully undervalued given the sort of overall position of the company |
| And what we've said publicly about the study on Slide 16 is that we meaningfully exceeded that response rate and that we had numerically higher responses for dose tapering and ATD discontinuation in patients on the higher doses compared with the lower dose, which we think sets us up really well to be not only we believe sort of first in class in Graves disease, but potentially best in class in Graves disease given our unique profile |
| So we're pleased with that |
| I think, overall I'll say, we were pleased with our ability to make the arguments that we thought were important to us |
| I can't say exactly when we will, but I am enormously excited at some of the things that we have our eyes and potentially hands on |
| We're optimistic about the mechanism here |
| So, a tremendously exciting drug |
| That's against a backdrop on Slide 12 of continued and growing evidence that deeper IgG suppression in general yields better clinical benefit across a variety of indications |
| So, a really exciting opportunity, and notably, our next fiscal year, we will have a quarter of sales and hopefully some data on script volume in atopic dermatitis |
| That includes data from both our TED study, which we've made fully available and our graves’ study, which we have not, in both of those studies, we were able to see significantly better efficacy at our higher dose, 680 milligrams of batoclimab, equivalent to 600 milligrams of IMVT-1402 |
| On Slide 9, as a reminder, we are very excited about our late-stage program |
| Something that we think will help us to fully realize the value of that, we think potentially best-in-class anti-FcRn antibody |
| And we are excited to continue to see that growth develop |
| We appreciate another quarter with a lot for us to be proud of and a lot to look forward to in building year for 2024 |
| And the reason we're not talking very much about it right now, is it's broadly a competitive space and we think we have an opportunity to be ahead |
| As a reminder, we are very excited about the next-generation antibody there, IMVT-1402, which we think offers deep IgG lowering, similar to batoclimab, we think as deep as any anti-FcRn antibody that we are aware of, with a clean analyte profile, with no and minimal effect on albumin and LDL, formulated for a simple subcutaneous injection, designed to hopefully enable self-administration, with an auto-injector and with patent life that goes out on a competition of matter basis, not excluding PTEs until 2043 |
| And we showed pretty remarkable data over a 50%, IGA, score of clear, and 80% EASI75 improvement |
| The sort of high prescribing docs write the product all the time and are really excited about it |
| But I think if you gave me a crystal ball, and it showed that we kept all of the programs in our pipeline, and they were sort of commercial opportunities for us down the line, I'd be pretty excited about that |
| Statement |
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| That is the level of EPS pressure, is significant |
| I want to report that unfortunately, the data generated in that Phase 1/2 study did not meet our bar for progressing |
| And then, sorry, you might've had all of GTN yeah, look, I think, it's been sort of slow and steady-ish for us |
| The problem was we saw, as we've indicated, the largest placebo response rate, I think ever observed in an SLE study |
| There's still a little bit of lumpy contracting stuff to get through just as some of the contracts have kind of turned over or changed, but in general, I'd say like slow and steady accretion over the course of the year, we may dip a little in the first quarter or be flat-ish in the first quarter for sort of normal reasons related to plan resets, et cetera |
| You mentioned you see a steady -- slow and steady over a period of next year |
| And the IRA is forcing our partners to rethink their development plans in various ways |
| And nothing that stands out a as particularly problematic |
| Unfortunately, it did not meet our bar, or the primary endpoint |
| I just -- I think we will continue to be ruthlessly economic along the way |
| And then, my guess is the AD launch won't like halt our progression, but it may momentarily slow it as we just need to make sure formulary sort of gets set up there quickly |
| So if someone is doubling down on immunology, maybe something else is falling out as a consequence |
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