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| Statement |
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| These efforts resulted in strong and steadily increasing demand with increasing breadth and depths of prescribing nephrologists |
| With all of this in mind, I could not be more excited about FILSPARI's prospects in this New Year and we feel strongly that we are well positioned for significant growth in 2024 |
| We will not be providing guidance on those for the year but we certainly do expect to see a strong year of our performance, particularly in revenue |
| We are proud to help lead the growing evolution of the treatment paradigm that we believe will ultimately see patients get diagnosed and initiate treatment earlier and where physicians will ultimately utilize FILSPARI as a foundational treatment with its superior proteinuria reduction and accrual of kidney preservation benefit |
| But we also saw like a good progress in our -- getting patients on paid product |
| I am very pleased with our results |
| Yes, as I mentioned earlier, I think the -- across the 3 core fundamentals of launching a product that we made really substantial progress and in particular like ASN, I think, really allowed for building that momentum we saw like an increase of prescriptions, in particular, from thought leaders |
| Let me just first say that Peter's team has done a really great job starting the year strongly and we've seen good performance |
| I am incredibly grateful and proud of how our colleagues at Travere learn and quickly adjusted |
| And I think our goal is to make sure that we continue to expand for new physicians to be able to get that clinical experience and we believe that positions us very strongly for future growth |
| There's really like great appreciation for the -- for the very robust results that we have |
| The guidelines to be updated that is a good momentum to show continuation of growth in patient start forms and more importantly, ultimately in revenue as well |
| Finally, I'm particularly excited about the advancement of our development program for pegdibatenase as the only potential disease-modifying therapy in a market that is expected to grow meaningfully over time |
| Strong launch performance in FILSPARI remains our top priority for 2024 and we expect the momentum in our launch from the second half of 2023 will continue into the New Year |
| We see near-term and long-term growth through the following: the continued strong execution of our FILSPARI launch, the expected conditional approval of sparsentan in the EU and full approval of FILSPARI for IgAN in the U.S |
| But if I look at the fundamentals, I'm really pleased with the progress we have been making |
| So I think in the first year, the plans to have the continued growth that we saw, I'm really pleased with |
| Our organization is well positioned with a strong financial foundation to continue advancing FILSPARI and pegtibatinase as potential future treatment standards for their respective rare kidney and metabolic disorders |
| I'm very pleased with the progress made on our clinical and medical affairs initiatives in 2023 |
| With our achievements last year, we are well positioned to ultimately deliver two new treatment standards in rare diseases with limited options available |
| Well, we remain optimistic about the positive CHMP decision that will be made this first quarter |
| And I'm really proud on the progress our commercial team has made in the past year, especially while adapting to the initial promotional restrictions that come with accelerated approval and an unexpected advance program for liver monitoring |
| So good progress there |
| And I think what you saw in this quarter is that we made robust progress in particular, also in the pocket of patients that we described in the earlier quarter that required some additional handholding and education with regards to the REMS loss I think -- as I mentioned, like the patient REMS certification within the first 14 days has increased quite substantially and that allow patients to go through the process and get to base product more quickly |
| So far, we see very strong compliance rates |
| Following our fourth quarter results, we are in a strong financial position |
| And I think now with FILSPARI, they feel like, hey, you know what, we are able to reach the target and I think that is motivating patients to continue to use the product and supply I think we see also high compliance rates |
| As I mentioned earlier, I think we're making robust progress on all the fundamentals, including the pull-through getting patients on base product |
| Following the positive results from PROTECT, we successfully completed a pre-NDA meeting with FDA to discuss our plans to submit an sNDA to convert FILSPARI from accelerated approval to full approval for IgAN |
| Our team is ready to show the true potential of FILSPARI in this New Year and we have multiple inflection points throughout 2024 that provides confidence in continuing growth |
| Statement |
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| Last year, we encountered a challenge in our pursuit of a better outlook for the FSGS community |
| Specifically, the DUPLEX study of sparsentan in FSGS did not achieve the results we had hoped |
| And I think you have to take into consideration like a lot of those patients, they feel that they're losing |
| Endothelin-I and angiotensin II, that both work together to drive damage and kidney function loss |
| The new start form increase was somewhat more modest |
| We also believe that the proteinuria target for treating IgAN overall will be lowered which would support earlier diagnosis, more aggressive treatment to avoid long-term damage as well as combination treatment in the future |
| And then secondly, as I look at the PSFs quarter-over-quarter so far in last year and as those growth rates moderate a bit |
| I think it's the characterization that you have to take it into context of a prescriber base that had very low innovation in the last 30 to 40 years |
| And I think also there isn't a controversial aspect for this |
| Net loss, including from discontinued operations for the fourth quarter of 2023 was $90.2 million or $1.18 per basic share compared to a net loss of $65.8 million or $1.03 per basic share for the same period in 2022 |
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