Liquidia Corporation

Good morning and welcome everyone to the Liquidia Corporation first quarter 2024 financial results and corporate update conference call. My name is Michelle and I'll be your conference operator today. Currently, all participants are in listen-only mode. Following the presentation, we will conduct a question and answer session. Instructions will be provided at that time for you to queue up for questions. I would like to remind everyone that this call is being recorded. I will now hand the call over to Jason Adair, Chief Business Officer.

Thank you, Michelle. It's my pleasure to welcome everyone to the Aquitia Corporation's first quarter 2024 financial results and corporate update call. Joining the call today are Chief Executive Officer, Dr. Roger Jeffs, Chief Operating Officer and CFO, Michael Cassetta, Chief Medical Officer, Dr. Rajiv Sagar, Chief Commercial Officer, Scott Mumaw, and General Counsel, Rusty Schundler. Before we begin, please note that today's conference call will contain forward-looking statements, including those statements regarding future results, unaudited and forward-looking financial information, as well as the company's future performance and or achievements. These statements are subject to known and unknown risks and uncertainties, which may cause our actual results or performance to be materially different from any future results or performance expressed or implied on this call. For additional information, including a detailed discussion of our risk factors, please refer to the company's documents filed with the Securities and Exchange Commission, which can be accessed on our website. I would now like to turn the call over to Roger for our prepared remarks, after which he'll open the call for your questions. Thank you, Jason.

Good morning, everyone, and thank you for joining us today. In the nine weeks since our last earnings call, we have continued to advance what we believe will be the industry-leading portfolio of inhaled terprocino products. Eutrepia, our dry powder formulation of terprocino, currently awaits final FDA approval to treat both pulmonary arterial hypertension, or PAH, and pulmonary hypertension associated with interstitial lung disease, or PHILD. We have continued to optimize our commercial preparations in anticipation of potential FDA final action and launch. In the clinic, we are seeing encouraging initial data from our assent trial of eutrapia and PHILD. In addition, our sustained release liposomal formulation of tropostanil L606 also continues to generate encouraging data in our open-label safety study in both PH and PHILD patients. Rajiv and Rusty will provide updates in greater detail on the clinical, regulatory, and legal fronts in a moment. But first, I think it is important to reflect on what is happening in the market and why we are so committed to these programs and the patients we seek to treat. We believe the market for inhaled tryprosinol and PH and PHILD can eclipse $3 billion at peak sales. And this is validated by Tevesa's total current annual run rate of approximately $1.5 billion, which continues to grow at an appreciable rate. This growth is driven by the expanded PHLD market, which is only marginally penetrated at this time, along with the availability of the more portable dry powder inhaler option. However, what we also see in our competitive sales data is continued unmet need. In our study of eutrapia, 100% of patients who transitioned to eutrapia from Tyveso preferred eutrapia after four months of use. Yet, approximately 40% of euthersales continue to come from nebulized Tyveso with its bulky, challenging, and dose-limiting nebulizer. We do not have any direct knowledge of the totality of issues that may be preventing a more complete conversion of patients from Tyveso to Tyveso DPI. but the continued prevalence of Tyveso seems illogical, given the clear portability and use advantages of the DPI. In this regard, data from the National Jewish Pulmonary Hypertension Program may be broadly informative. In September, these experts presented a single-center prospective observational study in patients with PHILD who were initiated on Tercocin on DPI. Of the 26 patients with PHILD initiated on Tyveso DPI, 69% of these patients discontinued this treatment after a mean of only 78 days or a median of 40 days. Of importance, 11% or 42.3% of these patients transitioned to the Tyveso nebulizer upon discontinuation of DPI therapy. This is highly consistent with our competitor sales data, highlighting that nearly 40% of its patient base continues to use the more cumbersome nebulizer for Tyveso administrations. From our perspective, clearly it is not the molecule tryprosinol, but rather the limitation of the formulation and the very high resistance DPI utilized with Tyveso DPI, especially when treating patients with lung impairment in PHILD. That's why we believe that physicians and patients are eager for a new choice, one that delivers a readily titratable and durable inhaled formulation of tryprosinol using a portable, patient-friendly, low-resistance dry powder inhaler with demonstrated high patient preference and satisfaction. Eutrapia is that choice and has the very real potential to become the first in choice in best-in-class prostacyclin in this growing market opportunity. With that, I'd like to ask Rajiv to share more about FDA interactions and our observations in the ongoing clinical studies with Eutrapia and L606. Rajiv?