Liquidia Corporation (NASDAQ:LQDA) Q3 2023 Earnings Call Transcript

Liquidia Corporation (NASDAQ:LQDA) Q3 2023 Earnings Call Transcript November 7, 2023

Liquidia Corporation misses on earnings expectations. Reported EPS is $-0.24 EPS, expectations were $-0.2.

Operator: Good morning, and welcome everyone to the Liquidia Corporation Third Quarter 2023 Financial Results and Corporate Update Conference Call. My name is Therese [ph], and I will be your conference operator today. Currently, all participants are in a 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 conference call is being recorded. I will now hand the conference call over to Jason Adair, Chief Business Officer.

Jason Adair: Thank you, Therese. It’s my pleasure to welcome everyone to Liquidia’s third quarter 2023 financial results and corporate update conference call. Joining the call today are, Chief Executive Officer, Dr. Roger Jeffs; Chief Financial Officer, Michael Kaseta; Chief Commercial Officer, Scott Moomaw, Chief Medical Officer, Dr. Rajeev Saggar 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 will open-up the call up for your questions.

Roger Jeffs: Thank you, Jason. Good morning, everyone and thank you for joining us. 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. 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. 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.

In support of this, a recent summary from our open-label clinical experience shows how durable and titratable YUTREPIA treatment can be, where we’ve treated patients for as long as 5.5 years and have titrated to doses now equivalent to 30 breaths of Tyvaso four times per day. 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.

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Q&A Session

This liposomal formulation delivered in two administrations per day offers more consistent drug exposure throughout the day, including during sleeping hours. Each dose is delivered in approximately one minute using simple titer breathing with a portable next-generation breath-activated nebulizer. We have plans to share data at conferences in 2024, but our preliminary data suggests that patients in the open-label study who have transitioned from Tyvaso have been able to safely titrate to higher doses, including daily doses comparable to 25 breaths of Tyvaso four times per day without any reported throat pain to date and only mild to moderate and expected adverse events in a minority of patients. We very much look forward to sharing more details on the development and registration path for this program during our future earnings calls, which will be informed by our Type C meeting scheduled with the FDA next month.

While we are very excited about our L606 program, we recognize that most of our investors’ attention is focused on near-term legal events. The good news is that legal story has now become greatly simplified. There’s just a single patent, ‘793 patent that currently supports the injunction preventing the FDA from gaining full approval of YUTREPIA. All claims of that patent were found to be invalid by the Patent Trial and Appeal Board or PTAB. The PTAB’s favorable decision is currently being appealed by United Therapeutics with oral arguments scheduled for December 4. We expect the decision could be issued as quickly as a few days after oral argument if summary affirmance is granted or within just a few months after oral arguments, the former written decision is provided.

Regardless, if the PTAB decision is a firm, we will immediately seek to have the injunction lifted and request final approval from the FDA. In the event of such an approval we will execute on our plan to change the landscape of the PAH market as quickly as possible. For this reason, I have asked Scott Moomaw, our Chief Commercial Officer to introduce himself broadly to our investors and to provide an update regarding our commercial preparations. Scott?

Scott Moomaw: Thanks, Roger. As a brief introduction for those that I have not yet met, I’ve had more than 20 years in the pharmaceutical industry building commercial teams and launching products. I spent 13 of those years in the pulmonary hypertension market, including leading the marketing of treprostinil products Remodulin, TYVASO, and ultimately the launches of Orenitram and treprostinil injection. Two years ago I joined Liquidia, when RareGen a company I co-founded with Roger and others merged with Liquidia. Since then I’ve been building our commercial strategy and our team for the upcoming potential launch of YUTREPIA. We’ve really built a strong senior commercial management team across marketing market access and sales leadership.

On the marketing and market access side, our team is ensuring that patients who are prescribed YUTREPIA will be supported by a full suite of services including high-touch specialty pharmacy, services, a patient access program and a co-pay card program. On the sales side very exciting. 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. Collectively, our sales team has an average of nine years selling rare disease products with the majority of the team having sold PH products previously. The team is now in the community and academic center offices increasing the awareness of Liquidia and supporting treprostinil injection more widely than ever.

We want all physicians to know that Liquidia is here for patients at any stage of the disease progression. 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. With that I’ll pass it over to Mike to review the last quarter’s results. Mike?