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| Statement |
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| As a result of our preparation to date, I am proud to say that Liquidia is ready and well positioned to launch YUTREPIA in both PAH and PH-ILD upon final FDA approval |
| The third quarter was marked by continued and positive steps to change the future of the company, the PH market and the lives of patients we are committed to serve |
| Many of you know already that YUTREPIA, our dry powder formulation of treprostinil using a low effort, simple-to-use pocket-sized dry powder inhaler has the potential to be the first and best choice when adding the prostacyclins to a patient's treatment regimen |
| I want to emphasize those matters, as it has been demonstrated across all routes of prostacyclin use that higher doses equate with better patient outcomes |
| YUTREPIA's ability to dose higher has the potential to significantly broaden and improve upon the therapeutic index and utility of inhaled treprostinil administration as it currently exists |
| At the same time, we've seen promising early evidence of clear benefits in our sustained-release inhaled treprostinil program called L606 |
| We've really built a strong senior commercial management team across marketing market access and sales leadership |
| On the sales side very exciting |
| So we're excited about it |
| And we believe all of these will portend to improve clinical outcomes for patients both in PH and PH-ILD |
| So first, yeah, just to re-highlight, we remain quite enthusiastic about YUTREPIA using our PRINT formulation, as well as a low-resistant device |
| We believe that this will be quite differentiated in the market especially in the PH-ILD market |
| We have always discussed that some of our key pillars that YUTREPIA offers are improved tolerability |
| During the quarter, revenue from treprostinil injection increased $0.5 million compared to the same quarter last year due to favorable gross to net chargebacks and rebate adjustments which offset lower sales quantities compared to the same period in the prior year |
| We have built a portfolio that we believe includes the most promising products in the fastest-growing area of the PH marketplace in treprostinil for the treatment of pulmonary arterial hypertension or PAH; and pulmonary hypertension associated with interstitial lung disease or PH-ILD |
| The good news is that legal story has now become greatly simplified |
| We have now reached doses equivalent of 30 breaths of Tyvaso four times a day, which is just quite remarkable to see these high doses being used safely in these patients |
| Just last month we were pleased to complete the onboarding of our field force of about 50 sales reps who share my passion for helping patients suffering from rare diseases |
| I hope investors can hear our enthusiasm and level of excitement |
| The team is now in the community and academic center offices increasing the awareness of Liquidia and supporting treprostinil injection more widely than ever |
| This liposomal formulation delivered in two administrations per day offers more consistent drug exposure throughout the day, including during sleeping hours |
| We believe that our proposed clinical paradigm of advancing a single Phase 3 study in PH-ILD that's placebo-controlled using L606 achieving a robust primary endpoint will lead to the ultimate approval of both PAH and PH-ILD in the near future |
| So, I intentionally let the team answer most of the call today because I wanted the investors to hear the depth and quality of the team that we have that are ready and very excited about launching YUTREPIA in the very near future |
| The other thing you can hear is the quality of YUTREPIA's product profile and its potential to quickly differentiate and become the prostacyclin of first choice as was asked about |
| Rajeev can chime in if he sees that differently, but we think that we have a significant potential here |
| And most importantly, we show durability with the use of YUTREPIA with now patients being exposed for as long as up to 5.5 years, which we believe highlights the durability and compliance with this – with YUTREPIA itself in this population |
| We are now fully prepared to enter the marketplace and upon approval promote the full benefits that YUTREPIA can provide to patients in their journey to feel better |
| So we feel like the market for PH-ILD, the prevalent market is about 60,000 patients and we all know that there's a significant potential here because of the unmet need |
| We think that actually two companies in this space educating center physicians, you probably see these patients already, but also community physicians who may see these patients, but not recognize it should grow that market quickly |
| Good morning, everyone and thank you for joining us |
| Statement |
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| There's just a single patent, '793 patent that currently supports the injunction preventing the FDA from gaining full approval of YUTREPIA |
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