Good morning. And welcome everyone to the Liquidia Corporation Second Quarter 2022 Financial Results and Corporate Update Conference Call. My name is Angela, 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. [Operator Instructions] I would like to remind everyone that the conference call is being recorded. I will now hand the call over to Jason Adair, Senior Vice President, Corporate Development and Strategy..

Thank you, Angela. It is my pleasure to welcome everyone to Liquidia’s second quarter 2022 financial results and corporate update conference call. Joining the call today are Chief Executive Officer, Roger Jeffs; Chief Medical Officer, Dr.

Rajeev Saggar; General Counsel, Rusty Schundler; Chief Financial Officer, Mike Kaseta; and other members of Liquidia management.

Before we begin, please note that today’s conference call will contain forward-looking statements, including those statements regarding future results 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 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 for your questions..

Thank you, Jason, and good morning, everyone. Over the last three months, we’ve continued to gain momentum across all areas of the company as we build towards our primary objective of preparing for the potential launch of YUTREPIA, an inhaled dry powder formulations to treprostinil. I’ll share just a few examples of our progress.

In the marketplace we continue to build the awareness and reputation of Liquidia amongst key stakeholders involved in delivering treatments for PAH, while also increasing utilization of treprostinil injection.

In the clinical arena, we published data from the completed INSPIRE trial in the Journal of Public Pulmonary Circulation, which validates the enduring value and therapeutic potential for YUTREPIA to be a game changer for PAH patients.

In the regulatory area, the FDA confirmed that no additional studies will be required to seek label expansion to treat patients with PH-ILD in March 2020. In illegal forums, we advanced down the path towards YUTREPIA’s final approval for the PTAB and validating all claims of the 793 patents.

On the balance sheet, we continue to build for launch, while being efficient with our use of capital and inside the company, we continue to build our high performing culture, hiring key people to enable both near- and long-term success of our products and pipeline.

Speaking of hires, I want to introduce you to one of our key new hires, our new Chief Medical Officer, Dr. Dr. Rajeev Saggar. Rajeev and I’ve known each other for years and he’s always impressed me with his determination to make a difference in patients lives. When I saw the opportunity to include him on our team, I took it immediately.

Rajeev brings a strength of knowledge, experience and curiosity that will help take Liquidia to the next level. Since most of our investors have not had the chance to meet Rajeev, I’ve asked him to share his impressions so far.

Rajiv?.

Thank you, Roger. I’m very excited to join Liquidia at a pivotal moment in the company’s evolution. We are just steps away from the potential introduction of YUTREPIA with the central and critical treatment modifier of the prostacyclin pathway.

With immediate focus on the potential launch of YUTREPIA, we are committed to the continued scientific research and education efforts in pulmonary hypertension for patient, clinician and the broad community. YUTREPIA was first introduced to the PH community in 2015 and just two years later started enrollment in the INSPIRE trial.

The first program to explore the benefits of an inhaled dry powder formulation of treprostinil for patients who were naïve to prostacyclin therapy or transitioning from nebulized Tyvaso.

During that time, I was a pulmonary specialist and clinical scientists with a focused interest in pulmonary hypertension, and along with many other investigators was thrilled to participate in the study.

Now as the Chief Medical Officer, I am poring over the robust clinical data that includes longitudinal patient exposures to YUTREPIA, exceeding three years between the INSPIRE study and ongoing extension trial.

In fact, we recently announced a publication of the completed INSPIRE trial, which included patients treated between eight months and 18 months before enrolling into the extension trial.

In reviewing the data, I was pleased to confirm that YUTREPIA can be safely titrated across doses comparable to three to 24 breaths of Tyvaso, indicating that a wide range of therapeutic doses can be easily administered just a few breaths from one or two capsules of YUTREPIA as compared to nebulizers. YUTREPIA treatment is also durable.

In fact, of the 121 patients enrolled, more than 90% completed treatment at the primary month to endpoint and when combined with exposure data from the extension study, we saw that more than 75% of patients completed treatment of at least 12 months. Lastly, YUTREPIA is attracted to patient.

After only two weeks, nearly all of the transition patients preferred or strongly preferred the DPI over the nebulizer. Only one patient reported no preference after two weeks, but at four months 100% of transition patients preferred YUTREPIA. We believe this data demonstrates the patient’s unmet needs and potential for rapid adoption when available.

All of this data has been enabled by our proprietary PRINT formulation of unified dry powder particles, ideally sized in the respirable range to enhance drug exposure, while using an inhaler very familiar to clinicians who have treated tens of thousands of COPD and asthma patients with a similar device.

We believe that YUTREPIA’s profile will help build on the body of knowledge and medical literature that higher inhaled doses may lead to better clinical outcomes.

Though we are not required to generate new clinical data to seek pulmonary hypertension associated interstitial lung disease in the YUTREPIA label, we will look for opportunities to fully explore YUTREPIA with a held -- with the help of the wider community.

Roger?.

Thank you, Rajeev. Beautifully stated. It’s exciting to think where we can guide the company with your help. But first and foremost, we need to get the product approved. I’d now like to ask Rusty Schundler, our General Counsel, that you’ve never seen our legal case to summarize our key legal advances in just this past quarter.

Rusty?.

Thanks, Roger. We have recently taken two major steps toward resolving the outstanding claims brought by United Therapeutics. First, we have submitted all post-trial briefings in our Hatch-Waxman litigation in the United States District Court for the District of Delaware. As previously disclosed, trial was completed at the end of March.

Thus with the submission of all post-trial briefings, the court now has all of the material required to reach a decision on the alleged infringement of the API manufacturing patent, which we refer to as the 066 patent and the method of use pen, which we refer to as the 793 patent.

The trial materials and transcripts are available from the court and we believe demonstrate all claims asserted are invalid and/or not infringed. We do not know when Judge Andrews will issue its ruling, but do expect that it will come before the end of October when the regulatory date expires.

Second, we have successfully concluded the inter partes review of the 793 patent with the Patent Trial and Appeal Board or PTAB, ruling in July that all claims are unpatentable.

The PTABs ruling is not binding on the court and the Hatch-Waxman litigation and would not override an order of the court that the -- that YUTREPIA may not be approved due to infringement of the 793 patent unless and until the decision of the PTAB is affirmed on appeal.

However, coupled with United Therapeutics prior stipulation of partial judgment in favor of Liquidia with respect to the 901 patent, another patent that was initially asserted against Liquidia, the PTAB’s ruling means that even before the decision in the Hatch-Waxman litigation, Liquidia has now received favorable rulings with respect to two of the three patents initially asserted by United Therapeutics against Liquidia.

We will continue to keep you updated on any material developments as we approach the court’s decision..

Thank you, Rusty. I’d now like to ask Mike Kaseta to highlight a few points from the second quarter..

Thank you, Roger, and good morning, everyone. Our second quarter 2022 financial results can be found in the press release issued earlier today and on our Form 10-Q to be filed with the SEC after market closed today.

In those documents, you will see that revenue of $3.9 million for the three months ended June 30, 2022, compare to $3.4 million for the same quarter in 2021. Revenue related primarily to the sale of treprostinil injection under the profit split agreement with Sandoz.

It is important context that despite the decrease in our profit split percentage from 80-20 to 50-50 in Q3 2021, quarterly revenues have increased each quarter since the launch of treprostinil [ph]. We continue to see consistent demand with more than 500 patients on treatment and increasing support from payer mandates for generic use.

Cost of revenue was $0.7 million for the quarter, which was the same compared to second quarter 2021.

Research and development expenses were $5.2 million, compared with $4.6 million, a $0.6 million increase from the same quarter last year split between timing of manufacturing related to the YUTREPIA program and a one-time charge for personnel related costs.

General and administrative expenses were $6.9 million, compared with $4.4 million, a $2.5 million increase of which just over half was due to increases in commercial, marketing and personnel expenses in preparation for the potential commercialization of YUTREPIA.

Other expenses in the quarter totaled $0.5 million, an increase of $0.3 million over the same quarter last year related to higher interest expense on our debt with Silicon Valley Bank.

All told -- all totaled, we incurred a net loss in the second quarter of 2022 of $9.4 million or $0.15 per basic and diluted share, compared to a net loss of $6.5 million or $0.13 per basic and diluted share for the second quarter of 2021. Turning to our balance sheet, we ended the second quarter well prepared to execute on our plans.

As of June 30th, cash and cash equivalents totaled $103.8 million, as compared to $57.5 million as of December 31, 2021. We believe that the cash on hand combined with revenue from treprostinil injection will support operations into 2024. I would now like to turn the call back over to Roger..

Thank you, Mike. At this time, I would now like to open it up for questions. Operator, first question please..

[Operator Instructions] Your first question comes from the line of Greg Harrison with Bank of America. Your line is open..

Hey. Good morning. Thanks for taking the questions.

First, I wanted to ask how quickly can you launch if the Hatch-Waxman decisions are favorable and what preparations are underway, I know the press release mentioned new hires in sales, are those contingent on resolution of the trial and a full approval?.

Hey, Greg. This is Roger. Thanks for the question. So the launch timing from once we have a successful resolution of the Hatch-Waxman trial, we believe will be between weeks to a maximum of, say, two months and really that’s just us resubmitting for final approval will be a small bit of final safety data that will submit along with that.

We’ve already discussed how our labeling will be finalized. So I don’t think there’s going to be any labeling revisions required. So it’s -- we think we’ll be on the shorter end of that two to -- two weeks to two months spectrum. And then, secondly, in terms of your question of prep, we have hired key leadership positions.

So, obviously, with bringing Rajeev in with his expertise, which you could hear very eloquently in his summary of the data today. We’re bringing in what we call Regional Business Directors, which are the key regional sales heads for the different areas of the country.

We are out now interviewing in scaling our salesforce through contingent offers, as you as you surmise. So those are going to be contingent on final resolution of the Hatch-Waxman trial, because as we have been and will continue to be, we’re trying to be efficient with our use of capital. So we are preparing.

I think the other thing that you should notice, we are preparing commercial product and we will have commercial product ready for the market upon the resolution of the Hatch-Waxman trial. Thank you for the question, Greg. Operator, next question please..

Okay..

Your next question will come from the line of Serge Belanger with Needham & Company. Please go ahead..

Hi. Good morning.

A couple of questions on the ongoing legal proceedings, first on the timing of the District Court decision, just curious, I think, there was a recent post-trial briefing demanded by the District Court judge, curious if that potentially portends in earlier decisions then October? And then, secondly, maybe just talk about how different the 066 patent that remains at issue in the District Court litigation, how it differs to 901 and 793? Thanks..

Yeah. Thank you. Thanks for the question, Serge. Rusty, I’ll ask you to address those please..

Thanks, Serge. So, on your first question, regarding the timing of District Court decisions, it’s hard to predict when the courts can rule. You’re correct that the court did ask for some supplemental briefing. I think it was in July. But that does not necessarily mean that the decision will come earlier.

Again, we think it’ll be before the end of the 30 months day at the end of October, but beyond that, could theoretically be any day. So, again, it’s just hard to predict, because the courts are busy and they have a lot of competing demands on their time. On the second question, on the differences between 066 patent and the 901 and 793.

The 066 and 901 are both methods of manufacturing the treprostinil API. The 793 patent is a method of treatment patents. So the 793 patents quite a bit different from the 066 and 901 patents. The 066 and 901 patents are very similar as to what they cover, but the language of the claims is different.

And so, if you look at the claim construction and what that meant, as far as what the 901 patent covered versus the 066, there are some differences. So I’m not sure if that answers your question, but they do cover very similar things. But, again, there’s some key differences in the way the claims were structured in those two patents..

Thank you, Rusty..

Thanks for the color..

Yeah. Operator, next question please..

Your next question comes from the line of Matt Kaplan with Ladenburg Thalmann. Please go ahead..

Hi. Good morning, guys, and thanks for taking the question. Just as you kind of enter, you’re performing the preparation for commercialization.

What -- can you give us some of the sense -- some sense in terms of the feedback that you’re getting on the profile of YUTREPIA versus Tyvaso and what the response is from the treatment community so far?.

Yeah. Thanks, Matt. So I’ll start and maybe then I’ll ask Rajeev also to comment since he’s very close, obviously, to a number of the KOLs.

So I think for us, the things that resonate with the physicians and the patient community is, is the therapeutic, what I’ll call, the therapeutic flexibility of YUTREPIA, its ability to titrate its AE profile and its durability of use, which Rajeev mentioned in his opening comments. And the next thing that really resonates nicely is the ease-of-use.

So the portability, the low resistance device, just the encapsulated blister packed product, which is just easy to carry as well, doesn’t spill, there’s no orientation requirements. So there’s a number of what we call preferential aspects that the community is looking forward to.

But, Rajeev, maybe if you have any color that you’d like to add to that..

Yeah. Thanks, Roger. Thanks, Matt, for the question. I agree, Roger, with everything you said. I think what is exciting to the community is another opportunity to provide this form of inhaled treprostinil through a low resistance device, specifically, YUTREPIA.

I think the ability to provide for strength to different capsules, at least up to the 106 microgram dose and then to be able to continue to titrate to doses beyond what is typically known as nine to 12 breaths that we’ve seen with Tyvaso, so I think it’s going to be well received.

Typically, practitioners have been taught that Tyvaso effectively has a ceiling, because its inability to titrate under Tyvaso nebulizer. This is the first time we’re going to be able to offer patients opportunity to continue to match their clinical symptoms, a need by uptitrating Tyvaso deemed, sorry, uptitrate YUTREPIA deem fit by the provider.

So we’re really excited about that and that’s the feedback from KOLs. Thank you..

Great..

Thanks for the question. I appreciate it..

Okay..

Thanks. Operator, next question please..

Your next question comes from the line of Julian Harrison with BTIG. Please go ahead..

Good morning. Thank you for taking my question and welcome to Liquidia Dr. Saggar.

Most of my questions have already been asked, but I’m just wondering if you could talk now a little more about the key details, the provisional label for YUTREPIA, such as maybe the highest dose indicated and what that corresponds to in nebulized Tyvaso breaths equivalents or anything else you’re able to share at this time? Thanks..

Yeah. So I’ll just say what we’ve said publicly, which is that the label will include doses -- I have describe the exposure during the INSPIRE trial up to 212 micrograms four times a day. So that would be an equivalent of 24 breaths or more Tyvaso, given four times a day and we’re obviously doing it in two to four breaths per session.

With that -- with -- a very quick time to set up, there’s very little cleaning, no cleaning at the end of the day. So bit what I like to call a game changer, really change, completely changes the delivery profile of inhaled treprostinil both to be flexible therapeutic in terms of dose and also in terms of ease of administration.

And then, as Rajiv said, we have four capsule strengths that will accommodate these escalating doses. So and as I mentioned, those are being prepped now for launch. So we will be ready full force when we launched the product to initiate patients on therapy to transition Tyvaso patients and as well as to have hospital supply if needed.

So, again, really working hard to focus all our attention on the launch of YUTREPIA and blessed with a product profile that the product supports. Thanks for the question..

Thanks very much..

Operator, next question please..

There are no further questions at this time. Mr. Jeffs, I turn the call back to you..

Thank you. Thank you, Angela. I’d like to thank everyone for joining us on the call today. We absolutely appreciate your continued interest in Liquidia and we’ll certainly update you on our progress throughout the year. Thank you for calling and have a nice day. Bye-bye..

This concludes today’s conference. You may now disconnect..