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| Statement |
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| So, overall, very good quarter |
| We’ve been very fortunate with INGREZZA, really, since the early days of the launch that we’ve had very good persistency and compliance |
| It’s been a very, very good quarter |
| So we continue to increase the rate of TD diagnosis and I feel really good about the progress that we’ve made |
| So I’m very proud of the teams that have been involved in all of these successes |
| Obviously, we’re experiencing the benefits of the expanded sales team, and frankly, I can say that we’re growing nicely in all three of the business segments that we’re in, neurology, psychiatry and now LTC |
| Between our positive Phase III results in CAH, record INGREZZA sales and solid cash flow generation, we had an incredible quarter |
| So the feedback we’re getting so far is very positive |
| The INGREZZA commercial, marketing and medical teams are doing an excellent job continuing to build and develop the tardive dyskinesia market |
| I mean, I think we feel very strongly that the M muscarinic agonist approach in treating both neuropsychiatric and potentially neurological conditions, including those impacted by cognition, would actually provide a very broad set of opportunities for patients moving forward |
| Our financial profile strengthened in Q3, resulting in non-GAAP diluted earnings per share of $1.54 and over $1.5 billion in cash at quarter end |
| Q3 2023 was a great quarter for INGREZZA with both strong continued growth from our TD franchise and the initial rollout of the new HD Chorea indication, which I’ll discuss later |
| It’s been six years since our initial launch and I continue to be impressed with our team’s ability to help improve diagnosis and treatment rates for patients living with tardive dyskinesia |
| And our just announced increase to the full year guidance range reflects our confidence in continued strong growth |
| But we are growing nicely |
| Nice underlying growth |
| So as I mentioned before, it’s growing nicely and its really part of the reason that we’ve had such a nice Q3 |
| Congrats on another impressive quarter |
| Just as in TD, INGREZZA offers meaningful and differentiated benefits for HD Chorea patients, including high selectivity for VMAT2, rapid and sustained efficacy, good tolerability, simple one capsule, once daily dosing and comprehensive support programs |
| These are the reasons why INGREZZA is the most prescribed VMAT2 inhibitor and I’m confident that these attributes will translate well to the HD Chorea community |
| We always had high expectations for the opportunity in LTC and the team is doing a great job on delivering on those expectations |
| So really reflects both the LTC, psych, neuro team really doing an excellent job continuing to drive diagnosis and getting patients treated with INGREZZA |
| And so our team has done a really nice job, I think, of educating the care teams in the long-term care facilities, understanding the dynamics with LTC pharmacies and have done a nice job of really driving diagnosis and now treatment within INGREZZA in the long-term care segment |
| First thing to say is that we remain on track to be able to release the data from the focal onset seizure study for 352 in this quarter and we’re very excited about the asset in terms of the potential benefit that it can bring for patients with focal onset seizures |
| And with the current state that we have, I think, we are extremely well positioned to deliver well into the 2030s with our company as being a leader in neuroscience |
| We’ve not provided a guide at this point, but clearly you can see we’re on a path of generating improved operating income |
| And so we have room for improvement both in terms of the diagnosis rate and in terms of the frequency of the use of INGREZZA in that patient population |
| But what I will say is that we’re very excited about the opportunity to potentially make a meaningful difference within the CAH community |
| Given INGREZZA’s attractive product profile and differentiated attributes, I’m confident that Eric and his team will be able to change that |
| However, still half the time, patients are not offered a VMAT2 inhibitor and so I expect that that will continue to improve over time, especially as we continue to leverage the updated APA guidelines |
| Statement |
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| And so these patients are faced with a difficult conundrum, either having excess androgens or living with high GC exposure and the consequences of that |
| Patients are faced with dealing with the undesirable effects of excess androgen production or the undesirable effects of chronic treatment with high dose GCs |
| Today, the standard-of-care utilizing supraphysiologic doses of glucocorticoids to suppress excess androgen production creates unwanted side effects and long-term complications |
| Today, I could not be more pleased to discuss how we are fulfilling that promise |
| What is very clear from the discussions that we’ve had up to this point with KOLs, payers and regulators around the world is that the impact of long-term steroid use is detrimental in this patient population, particularly at supraphysiologic doses |
| And it’s a very difficult symptom set within the range of symptoms experienced by patients with major depressive disorder |
| So still lots of room for improvement despite the progress |
| Certainly patients that have, for various reasons in the past, declined treatment |
| But today you sort of shy away from putting those numbers, but did say that the bar is high or the efficacy shouldn’t be robust |
| As Eric noted, the vast majority of patients with HD Chorea are currently untreated |
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