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| For our BET inhibitor, again, we showed data at ASH and alluded in my prepared remarks, we have clearly an active compound showing very good rates of spleen reduction, both volume and length, very good symptom improvement and occasional hemoglobin increases, just like seen with the other BET inhibitor |
| Total product and royalty revenue reached $1 billion quarterly for the first time, driven by the continued growth of Jakafi and successful launch of Opzelura |
| And again, our Phase 2 proof of concept data is very strong in terms of the itch relief here and the ability to eliminate that symptom pretty quickly, as well as over time, disease resolution in the actual skin manifestations |
| So, we're not exactly sure, but we think there's a significant portion of patients that could benefit from these -- from Jakafi specifically that aren't because of the out-of-pocket cost, and that's getting better and better all the time, we hope, in 2024 and 2025 |
| And Opzelura saw strong momentum in 2023, growing 162% to $338 million, driven by new patient and refills in both AD and vitiligo |
| As you can see from Slide 18, we anticipate that 2024 will be another very exciting year with multiple clinical and regulatory milestones |
| Apart from an exhaustive list of all the R&D achievements in the past year, this demonstrates that 2023 was a very successful impactful year for Incyte and it serves as a foundation for a number of pivotal trials that will deliver results in the next few years |
| So Jakafi, as you know, is the leader in myelofibrosis because of its safety, efficacy, overall survival, and really tolerability, which is really a big advantage |
| This acquisition provides a number of benefits to Incyte in the short term |
| Second, we will realize significant operating efficiencies and cost synergies in US commercialization and in global development by removing redundant position and redundant external expenses and by simplifying the org chart |
| For the future, while the currently approved indication of relapsed/refractory DLBCL represents a smaller opportunity for tafasitamab, we see upside potential in second line follicular lymphoma and marginal zone lymphoma with Phase 3 data expected later this year and in first line DLBCL, for which Phase 3 data are expected in 2025 |
| These programs have been co-funded by MorphoSys until now and, if positive, Incyte will fully benefit from the upside from this indication |
| The launch continues to be strong and it's gaining positive momentum with both physicians and patients as Opzelura becomes established as one of the best recent dermatology launches |
| 2023 was another year of strong financial performance with total product revenues of $862 million for the fourth quarter of the year and $3.2 billion for the full year, representing a 13% and 15% year-over-year increase, respectively |
| Total revenues grew 9% in the fourth quarter compared to the prior-year period, reaching the $1 billion mark, an important milestone for Incyte |
| In terms of 2024, 2025 and the changes to Medicare Part D, we think it's been very positive |
| In addition to securing improved access for 2024, we are also continuing to look for ways to improve utilization management and we have an exceptional value proposition that supports these advancements |
| As highlighted on Slide 11, Jakafi continues to maintain its leadership and market share in MF, driven by its unmatched product profile |
| Jakafi demand remains strong and we expect continued future growth driven by maintaining its leadership as standard of care in myelofibrosis, growth opportunities in polycythemia vera and chronic graft-versus-host disease, as well as earlier use in chronic GvHD |
| Additionally, we anticipate the positive changes in out-of-pocket expenses for Medicare Part D patients to contribute to the growth in the coming years, with the biggest impact starting in 2025 |
| So, we think those dynamics are good for both AD and vitiligo going forward, and we can -- we're looking forward to future growth |
| So, on Slide 5, we achieved another strong year with 2023 product and royalty revenues growing 14% versus 2022 to reach $3.7 billion, continuing the strong performance we have delivered since 2018 |
| US patient demand increased during the quarter with total prescriptions growing 77% year-over-year and refills growing by 22% versus the prior quarter |
| The successful launch of Opzelura is driven by its compelling product profile, its ability to address significant unmet need in both atopic dermatitis and vitiligo and our strong market access relative to competition where we continue to improve access and growing net sales |
| So, we think there's great opportunities ahead for these two indications |
| We remain very optimistic about the long-term potential of Opzelura as we continue to see strong uptake |
| Maybe on the first question, as I said, I think the tafa acquisition for us is an excellent deal |
| Each of these programs have the potential to address a significant market and provide an opportunity to contribute to the top-line before the end of the decade |
| So, we're very excited about the early data of our CDK2 inhibitor, as we mentioned |
| Now, if any of this new indication is hitting and its positive then it becomes obviously a super deal because we get all the benefit in terms of top line |
| Statement |
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| You said that the fourth quarter revenues were negatively impacted by the number of Medicare Part D patients receiving free product |
| Jakafi sales were negatively impacted by a significant increase in free drug in the fourth quarter of the year, driven by an increase in the number of patients seeking support from Incyte's Patient Assistance Program |
| As of a result, Q1 Opzelura net product revenues are expected to be below the previous quarter and the subsequent quarters and represent a smaller share of the full year net product revenues, consistent with what we saw in 2023 |
| Steven Stein And, Ren, your question on XR, so just to go back to the CRL, remember, when we did the submission, we missed on Cmin to a small degree that per the FDA resulted in a theoretic concern on efficacy |
| And in fact, they probably are still too high |
| It's just for the lack of a better word, an engineering problem, but maybe I'm thinking about this wrong |
| And we have not seen ocular toxicity, which, as you know, led to a clinical hold in one of our competitors |
| As far as what we talked about seasonality, we do expect that the first quarter to be down mostly because of because of out-of-pocket expenses, because of deductibles, because of the resetting of the co-pays, but then we should go back to our acceleration in volume in second quarter, third quarter and so on |
| We've been saying it for a long time that these co-pay out-of-pocket cost for patients -- cancer patients who are in Medicare Part D was very much too high and should be reduced |
| While for Opzelura we will not be providing full year guidance at this point, in the first quarter, we expect to see again the effect of typical Q1 dynamics on net sales, including higher patient out-of-pocket costs due to the planned deductibles resetting at the beginning of the year and the impact of holidays, medical conferences and other events on dermatology product sales |
| Total R&D expenses were $444 million for the quarter, representing an 11% year-over-year decrease, which was primarily as a result of the $70 million upfront payment made as part of the Villaris acquisition in Q4 2022 and partially offset by the $20 million development milestone payment to former Villaris shareholders in the fourth quarter of 2023 |
| In PN, what patients suffer from primarily is intense itching |
| With the changes in Medicare in 2024, as you know, the out-of-pocket in 2024 for Medicare Part D is greatly reduced |
| Recall, inventory grew down modestly in Q3 and rebounded in the fourth quarter |
| The year-over-year increase of 8% for the fourth quarter and 16% for the full year were mainly due to increased sales and marketing activities for Opzelura in both the US and Europe, unfavorable effects and timing of certain G&A related expenses |
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