Sentiment Analysis of the earnings transcript to help figure out if there are any bullish or bearish sentiments that could be gathered from it. We're doing ML and AI based analysis on the earnings call to get some more insights.
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| And importantly, we have a track record of ensuring strong coverage and reimbursement for oral targeted therapies in difficult to treat diseases that we plan to continue with GAVRETO |
| We are thrilled with the significant progress we made in growing our hematology and oncology business in 2023 and in the early part of 2024 |
| In summary, we are well positioned to continue growing GAVRETO through positive momentum in these four key drivers |
| And finally, as we have discussed, as we leverage our strengths in coverage, reimbursement and patient services with Rigel ONECARE, we believe we can gain loyal users of GAVRETO from clinicians who view out-of-pocket costs and difficulty obtaining reimbursement as barriers for the use of RET inhibitors |
| This is an outstanding performance for both products and this growth can be attributed to the execution of our initiatives by our commercial and medical affairs teams, and frankly, across the entire organization |
| On Slide 22, you will see that 2023 was a strong year of portfolio growth as our quarterly US net product sales grew from $24 million in the first quarter to $29 million in the fourth quarter |
| That consistent quarter-over-quarter growth enabled us to generate total net product sales of nearly $104 million for the full year, $28 million more than 2022, representing an impressive 36% growth rate |
| We’re very proud of the progress we made in 2023 and in the early part of 2024, in expanding our hematology and oncology business |
| These alliances with MD Anderson and CONNECT, greatly enhance our ability to further evaluate REZLIDHIA’s potential in a cost efficient and time efficient manner |
| With the growth of TAVALISSE and REZLIDHIA sales and the addition of GAVRETO, which we expect to be start recognizing revenue in the third quarter of 2024, as well as our cost efficient and disciplined approach to clinical development, we are well positioned to continue growing our business and to reach financial breakeven |
| I think when you look at that barrier, we look at that as a great opportunity for us |
| And lastly, our access team has strong existing relationships with payers and networks which we will continue to leverage to ensure the same high levels of coverage and reimbursement that have led to our 97% commercial coverage we have achieved with TAVALISSE |
| We believe this momentum with new patient starts will continue to fuel growth of TAVALISSE in 2024 and beyond |
| We’re pleased with the financial leverage that we’re seeing and have been able to successfully grow sales of TAVALISSE and launch REZLIDHIA in both the community and academic settings within this cost structure |
| You’ll note in my review that this was accomplished in part through increasing net product sales, including royalty revenues, periodic drug supply purchases from our international distribution partners and continued disciplined operating expense management across our business |
| Further, with patents that are issued or expected to issue with a statutory expiration date between 2036 and 2041, we are well positioned to make GAVRETO available for years to come |
| We believe these are very good economics for Rigel and put us in a great position to begin recognizing product sales in the third quarter of 2024 and to begin capturing the value from this program in the near term |
| We are growing both breadth and depth of adoption among academic AML treaters and for 2024, we see a great opportunity to increase awareness and adoption of REZLIDHIA in the community setting |
| Those sales grew more than 21% above reported sales of almost $23 million in 2022 |
| So that’s why we believe it’s a great opportunity for us |
| We believe this compelling GAVRETO opportunity fits our business well for a few reasons |
| And they share with us a strong conviction in the potential of olutasidenib |
| We are very excited about olutasidenib’s potential to provide a much needed treatment option for these patients with such a poor prognosis |
| Secondly, we believe we have built strong access capabilities that we can immediately leverage to ensure current and newly prescribed patients have access to GAVRETO |
| We have an efficient distribution network with TAVALISSE and REZLIDHIA that will soon be ready to accommodate GAVRETO combined with our Rigel ONECARE patient services hub that has established a reputation for being highly responsive to patients and providers |
| First, we have an efficient distribution network for TAVALISSE and REZLIDHIA that swiftly and dependably delivers our products to accounts and patients overnight |
| Secondly, and more importantly for GAVRETO, choice of therapy in those identified patients who are treatment eligible is an impactable growth opportunity for us |
| TAVALISSE, the main driver of this growth, generated approximately $94 million in net sales, up 24% over the prior year |
| Our two marketed therapies, TAVALISSE in ITP and REZLIDHIA in mutant-IDH1 relapsed or refractory AML saw record sales in 2023 of $104 million, a 36% growth over 2022 |
| Genentech and Blueprint did a great job, along with other companies in the targeted space in lung cancer, raising awareness of testing, raising awareness that when you do have a biomarker with an actionable drug or an actionable biomarker with an FDA-approved product, you should be moving there |
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| And second to market is a more challenging situation, and that’s part of it |
| Historically, there is a great medical need as non-selective therapies in RET+ non-small cell lung cancer have shown poor outcome with an overall response rate inferior to 30% are associated with drug-related toxicity and a high rate of dose reduction in up to 75% of patients |
| So, given Blueprint medicine’s lack of global infrastructure, the company has decided to discontinue global development and wind down activities anticipated to begin in the first quarter of 2024 |
| One of the barriers what you said you noted was discomfort and familiarity with other drugs |
| When clinicians don’t test, it’s more likely due to not having adequate tissue available |
| And so I think that’s just an awareness issue that we’ll continue to assess and pursue |
| Can you maybe help us understand the gap between the sales of your drug versus the other RET inhibitor? It looks like they were both perhaps launched around the same time, but the sales of the competitor have taken off significantly |
| And so sending one of our institutional reps into an academic center with one product is not as efficient as sending them in to cover two departments with two products |
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