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| Statement |
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| Now, there are several primary drivers for this increase where we have increases in volume going through the commercial channel as a result the strong uptake in the bipolar program |
| So, the guidance that we put out, the main driver of that guidance is the underlying strong demand trend that we see in the business, and the continued demand for CAPLYTA |
| So, we think it can be a benefit to patients, and that's terrific |
| We feel across both schizophrenia and bipolar depression, we see very strong efficacy, a very favorable safety and tolerability profile, and a dosing regimen that physicians and patients really like |
| So, we have a great deal of confidence in the product that we have in CAPLYTA |
| Demand for CAPLYTA remains strong |
| Our well-executed commercial efforts continue to drive prescription growth from both new and existing prescribers |
| We anticipate continuing strong demand for CAPLYTA |
| Based on this positive momentum, I am pleased to report that we expect full-year 2024 CAPLYTA net product sales to be in the range of $645 million to $675 million |
| As I mentioned in our last call, from the end of Q3 2023 and the beginning of the fourth quarter, we negotiated an improvement in the utilization criteria for CAPLYTA with two of the largest Medicare Part D payers |
| So, we have, and you're, you were right to point out that that lumateperone has a very good safety and tolerability profile |
| And I guess what I would say is we believe with our current business in schizophrenia and bipolar depression, we are still in the early innings of tapping into the opportunity for CAPLYTA, and we see tremendous opportunities for continued growth in bipolar depression as we continue to penetrate that market |
| And with successful studies and a successful filing and approval, when we get to the market, we see that as a very, very robust opportunity for CAPLYTA |
| We are very encouraged by the positive reception our presentation received from the scientific and medical community |
| Given the efficacy and safety profile to date, we are confident in CAPLYTA's future potential in this patient population |
| But rather is confirmation of what we believe to be a very significant unmet medical need in MDD for an adjunct of antipsychotic with a good efficacy and safety profile |
| Mark Neumann Yes, sure, Jason, the dynamics that we're seeing in the MDD space for adjunct of antipsychotics is very encouraging to us in terms of the potential opportunity for CAPLYTA in the future and by that I mean Vraylar has had a very successful launch in MDD significantly growing that market, which is not a surprise to us |
| In summary, we continue the very successful launch of CAPLYTA, and are confident in the continued robust growth throughout 2024 |
| Finally, we continue to enjoy a strong market access position with over 99% of Medicare and Medicaid lives covered and about 90% covered commercial lives |
| CAPLYTA has a very compelling product profile that features strong efficacy and a favorable safety and tolerability profile |
| The significant uptake of the last two anti-psychotics approved for adjunctive treatment in MDD underscores the continued unmet need and the large opportunity in this market |
| So, we feel very good about the momentum we have |
| Looking ahead to 2024, we are starting off operationally and financially strong |
| I'm incredibly proud of our team and our accomplishments, and I'm excited to embark on our next phase of growth in 2024 |
| So, we had very strong fourth quarter accelerating our total prescription growth to 10% |
| So, we are good |
| 2023 was a year of tremendous progress in establishing CAPLYTA as the leading treatment option for patients with bipolar depression and schizophrenia, setting the stage for continued robust growth in 2024, and beyond |
| In summary, we made tremendous progress with CAPLYTA in 2023, and we are confident that CAPLYTA's favorable product profile, and our incremental promotional investment behind the brand will result in a robust year of CAPLYTA growth in 2024 |
| This past year was defined by strong and consistent growth throughout our company |
| We've also had consistently favorable results from our comprehensive direct-to-consumer platform, and we will continue these efforts throughout 2024 with a new creative campaign being introduced in Q2 |
| Statement |
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| I appear to be losing my voice |
| Typically as you alluded to in the first quarter, you see some typical headwinds associated with patients switching market access plan when you have a product like ours |
| The underlying business, the demand in the business, the reception that physicians have had to the product and the feedback that they provide to us on their experience and the patient's experience, but yes, typically in the first quarter you do see some headwinds, and then in the second quarter, you see a reacceleration and growth |
| So, we don't believe it's a share grab |
| I am sorry |
| CAPLYTA's favorable profile is very important, as these side effects can often lead to poor patient compliance and drug discontinuation |
| For patients, as you know, in this category, there's a tremendous amount of churn, what we call churn, meaning patients try one therapy often prior to CAPLYTA |
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