Liquidia Corporation (LQDA) Earnings Call Transcript & Summary

Good morning, and welcome, everyone to the Liquidia Corporation's Full Year 2022 Financial Results and Corporate Update Conference Call. My name is Chris, and I'll be your conference operator today. [Operator Instructions] I would like to remind everyone that this conference call is being recorded. And I will now hand the call over to Jason Adair, Senior Vice President, Corporate Development and Strategy. Sir, please go ahead.

Thank you, Chris. It's my pleasure to welcome everyone to Liquidia's Full Year 2022 Financial Results and Corporate Update Conference Call. Joining the call today are Chief Executive Officer, Roger Jeffs; Chief Medical Officer, Dr. Rajeev Saggar; Chief Financial Officer, Michael Kaseta; 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. The company will file its 10-K on Monday, March 20. I would now like to turn the call over to Roger for our prepared remarks, after which he will open the call up for your questions.

Thank you, Jason. Good morning, everyone, and thank you for joining us. As I look back on 2022, my first year as CEO of Liquidia, I remain humbled to have joined an organization that [indiscernible] services. My [indiscernible] to join the company in an operational role was related to the potential of YUTREPIA to universally transform prostacyclin therapy from a high burden treatment option to a low burden option for patients. Specifically, 4 key attributes resonated out with me: YUTREPIA's tolerability; YUTREPIA's titratability; YUTREPIA's durability; and YUTREPIA's usability and affordability. These 4 attributes continue to resonate with [ me ] and support my belief that YUTREPIA has the potential to be the prostacyclin therapy of first choice and best-in-class inhaled therapy for patients with either PH or PH-ILD. The open label extension data continues to mature, only first [indiscernible] in the commercial [indiscernible] potential of YUTREPIA to participate significantly in what is now the fastest-growing segment of [indiscernible] agent in the prostacyclin market. The other main [ excitement ] for joining this company [ is ] bench strength of the entire organization and our internal capability to manufacture drug substance in-house. Of course, it also didn't hurt that we already had tentative approval and labeling in hand. In 2022, we made key strategic hires to strengthen our core capabilities. And in concert with our legal success in 2022, Liquidia is now well positioned to maximize the commercial uptake of YUTREPIA on it's [indiscernible] launch. I'd like to now turn the call over to Rajeev Saggar, our CMO, and one of those key 2022 hires [indiscernible] on why we are so excited about YUTREPIA's unique product profile, and why we believe we are ideally positioned to provide a differentiated best-in-class option for patients. Rajeev?

Thank you, Roger, and good morning, everyone. In recent months, our team has engaged with the medical community about certain topics related to YUTREPIA, such as its product profile, the benefit of low-resistance dry powder inhaler device for patients, and our upcoming clinical plans. Today, [indiscernible] to briefly touch on these points. YUTREPIA was designed with a specific goal in mind, to deliver treprostinil to the deepest parts of the lungs across a wide range of doses in a broad range of patients with varying lung function. To achieve this objective, we [ aligned ] the whole PRINT technology with the RS00 Plastiape dry powder inhaler, a simple proven device used successfully by many tens of thousands of adults and children with [ breathing ] problems such as COPD and asthma. To the first point of expanding the dose range, our clinical study in pulmonary arterial hypertension, or PAH, proved that a 79.5 microgram dose of YUTREPIA is delivered at vial equivalent doses to 9 breaths breadth of nebulized TYVASO. But more importantly, YUTREPIA has been safely and conveniently titrated to doses comparable to 27 breaths of TYVASO, a level rarely, if ever, achieved with the nebulizer. To the second point of [indiscernible] our low DPI proved easy to use without need for advanced technology to train patients, and further demonstrated it is robust enough for [indiscernible] topping or positioning in a myriad of ways. In fact, given the device's proven track record with obstructive lung diseases there is considerable interest among medical professionals to use YUTREPIA, particularly for patients with pulmonary arterial hypertension associated with interstitial lung disease or PH-ILD where lung restriction and impaired respiratory effort are common. Put simply uniform PRINT particles in the [indiscernible] respirable range for deep lung delivery, providing consistent and [indiscernible] recovery with a low [ filters ] the device across a wide range of inspiratory efforts for PAH and PH-ILD patients. To further inform the use of YUTREPIA, the intended clinical trial later this year that will generate data on how YUTREPIA may be best utilized in PAH [ biology ]. We think an open-label study will greatly benefit our understanding of tolerability and the ability to titrate in this patient population. I'm [indiscernible] as we move closer to the potential launch of YUTREPIA. I'd like now to turn the call over to Rusty for an update on the legal proceedings. Rusty?

Thank you, Rajeev. As a reminder, the company has received rulings through proceedings in the court and in parallel inter-parties review proceedings before Patent Trial and Appeal Board or PTAB that all of the claims in the 3 patents asserted by United Therapeutics against the company are either invalid or not infringed by Liquidia. Over the last several months, we have seen further progress in our litigation to bring YUTREPIA to market. First, we are pleased with the PTAB's decision in February to reject United Therapeutics request for rehearing of the '793 IPR. In its decision, the PTAB clarified the grounds upon which it found that all of the claims in the '793 patent were unpatentable. United Therapeutics now has 63 days from the decision date of February 2 to file an appeal of the PTAB's decision. Assuming UT files an appeal, which they have publicly stated they will, we would project that oral arguments could occur as early as late fourth quarter of 2023 or first quarter of 2024. We would then anticipate that a decision could be rendered by the court as early as a few days after oral argument if the court issued a summary affirmance, or within a few months after oral argument of a full written opinion is issued. Second, we are pleased with the progress in the appeal of the District Court's decision in Hatch-Waxman trial. Briefing in that appeal has now been completed, and the court is in the process of scheduling oral argument, which we expect to occur sometime in the second or third quarter of 2023. As with the appeal of the '793 IPR, we would expect to receive a written decision of the court within a few months after oral argument. For all of these appeals, we will not summarize our arguments here. But all briefings are, of course, available to the public through the court's PACER system. Lastly, there may be opportunities to accelerate the time line in one or both appeal proceedings, and we will seek opportunities to proceed through the appeals process as quickly as possible. Finally, it is notable that United Therapeutics did not appeal the Hatch-Waxman decision related to the '901 patent, so that patent is no longer an impediment to our launch of YUTREPIA. With the '901 patent having been dropped, we will now be able to seek final approval for YUTREPIA if the decision of the District Court in the Hatch-Waxman litigation is affirmed on appeal with respect to the '066 patent, and either the District Court's decision regarding the '793 patent is reversed on appeal, or the PTAB's decision regarding the '793 patent is affirmed on appeal. In short, if the original decisions are affirmed on appeal, then we can seek final approval of YUTREPIA immediately. I will now pass the call on to Mike for an overview of our financial reporting. Mike?

Thank you, Rusty, and good morning, everyone. Before I address the results for the full year 2022, I wanted to briefly comment on the security of our funds and relationship to SVB, a bank with whom we've had a relationship for about 2 years. As previously disclosed, we repaid all debt owed SVB back in January as part of the financing agreement with HealthCare Royalty Partners. We also have maintained all cash and cash equivalents at SVB, 99% of which was held in a BlackRock mutual fund and the remainder of which was held in an operating account. On Tuesday this week, substantially all of our cash was transferred out of SVB to an accredited financial institution. We will continue to evaluate our cash management and investment policies in an effort to protect our capital from events similar to what occurred in the last week. Turning to our full year 2022 financial results, which can be found in the press release issued today. You will see that revenue increased to $15.9 million for the year ended December 31, 2022, compared with $12.9 million for the prior year. The profit split percentage we received under our promotion agreement with Sandoz was 50% for the entire year. Whereas in 2021, the profit split percentage decreased from 80% to 50% as a result of achievement of predetermined cumulative sales thresholds. Revenue in 2022 is net of $2.7 million in amortization of the contract acquisition costs associated with the promotion agreement. Next, cost of revenue was $2.9 million for the full year 2021 compared with $3 million for the prior year. 2022 included a full year of sales force related to -- sales force-related costs, as well as amortization of the intangible assets associated with the promotion agreement. Research and development expenses in 2022 of $19.4 million for the full year compared with $20.5 million the year prior. The decrease of $1.1 million or 5% was primarily due to a $0.9 million decrease in personnel, consulting and stock-based compensation expenses. General and administrative expenses were $32.4 million for the full year of 2022 compared to $23.1 million for the prior year. The increase of $9.3 million or 40% was primarily due to a $4.2 million increase in commercial, marketing and personnel expenses in preparation for the potential commercialization of YUTREPIA, and a $3.1 million increase in stock-based compensation expense driven by an option modification charge recorded in the first quarter of 2022. In summary, we have incurred a net loss of $41 million or $0.67 per basic and diluted share, compared to a net loss of $34.6 million or $0.70 per basic and diluted share for the year ended December 31, 2021. Turning to our balance sheet, we ended 2022 with $93.3 million of cash on hand. We further strengthened our access to capital in January through the revenue interest financing agreement with HealthCare Royalty for up to $100 million in 4 tranches. The first tranche of $32.5 million netted an approximate $10 million increase in cash after paying off the SVB debt facility. The remaining tranches are related to: one, clearance of the legal pathway; two, acquisition of an internal asset; and three, mutual agreement of the parties. I would now like to turn the call back over to Roger.

Thank you, Mike. Reflecting on the previous year, I can say with 100% of confidence that [indiscernible] prepared to deliver a potential of our products and [indiscernible] to patients. At this time, I would now like to open to questions. Operator, first question please.

[Operator Instructions] Our first question will come from Gregory Harrison of Bank of America.

As you start to get closer to launch, what feedback are you receiving from physicians or patients regarding the differentiation between YUTREPIA and TYVASO DPI and the demand for YUTREPIA when it comes to market?

Yes. [indiscernible] we're excited to answer. At this time, I'd like to pass that to Rajeev, maybe you can give some thoughts on these conversations you've had with various KOLs and then your own reflections on what [ differentiates YUTREPIA ] potentially from other DPIs in the space.

Thanks Greg. [indiscernible] to answer your question. First thing is that I think it's very important to understand that YUTREPIA has been studied in pulmonary arterial hypertension patients in the INSPIRE database. [indiscernible] enable to titrate successfully YUTREPIA to doses equivalent up to 27 breaths, 4x a day of TYVASO, which is incredible. I think that showcases: One, our tolerability; and number two, our titratability. Specifically, where the concern with pulmonary arterial hypertension associated with interstitial lung disease is of importance is because this population has not only pulmonary hypertension [ and ] vascular injury but they also have an interstitial disease, which causes a [indiscernible] vial capacity. We believe this is where YUTREPIA has the ability to shine in part because of its low resistance device that we're using. We believe this will allow the limitations of the patient's lung function to be better tolerable and suitable for our device in particular. To that end, we have -- we are hearing that our device, at least in those practitioners who have used it in our INSPIRE registry, feel like it has similarities to the simplicity of a nebulizer that, of course, that has all the benefits of a dry powder inhaler such as portability. To this point, we think, Greg, it's very important that we study some of these product profiles of YUTREPIA specifically in PH-ILD, where we believe this will have the highest utility and impact in. And that's where we alluded to that we will move forward with an open-label study, to really showcase and highlight: One, the tolerability of YUTREPIA in this patient population. As you know, there has not been an official study using a dry powder inhaler in PH-ILD, so we believe this is important, for the community and KOLs to experience. It showcases our ability not only in the tolerability, but as such, because of that improved tolerability, we should see titratability to higher doses in this patient population. So we look forward to initiating the study by the end of the year.

Thank you very much, Rajeev. Great answer, and it really sort of solidifies why we're so excited about the product profile of YUTREPIA our ability to capture a significant share of the market.

Our next question will come from Kambiz Yazdi of Jefferies.

Can you provide any granularity on kind of the gating factors to potentially starting a PH-ILD study? And then in terms of -- what feedback have you received on DPIs causing coughing in PH-ILD?

In terms of gating factors to starting studies, really, that's just our ability to get the protocol approved at ethics committees, CROs engaged and really just CTM for the study supply. So that's fairly simplistic. We're working on that now, and it's our intention to start those studies in the coming quarters. And then in terms of PH-ILD question, I'll let Rajeev speak to that.

Thanks, Kambiz. I think what we're hearing is several things is, one, I think patients without a doubt, like the convenience of a dry powder inhaler. So that's a fact. Number two, these patients that have pulmonary hypertension associated with interstitial lung disease [indiscernible] patients. [indiscernible]

Chris, this is Jason Adair. Rajeev, you cut out there when you started to explain the PH-ILD. I'm not sure if you could hear...

Can you hear me now? So in particular, with PH-ILD, because of the inherent limitations with cough in general, we are -- we understand that there's a certain number of patients in this population that tend to have [indiscernible] when exposed to a higher resistance [indiscernible] inhaler. And so it's done -- if this is done improperly, that potentially can cause the patient to have additional cough and limitations when they're exposed to certain types of dry powder inhalers.

Thank you Rajeev. So I think the importance now of our own [indiscernible] in patients with PH-ILD because it could be possible that not only the tolerability, but the rate of titration and that the patient -- that would be a little bit different with arterial hypertensions. But given the profile of our product, we're well positioned to test that in the next [indiscernible].

Our next question will come from Serge Belanger of Needham.

I guess just one question. I think Roger, you've highlighted over the last few quarters how YUTREPIA -- YUTREPIA inhaler is a low-resistance DPI inhaler and highlighted some of the benefits there. Maybe just talk about what are the benefits and how that inhaler differentiates the product from TYVASO DPI?

Yes, that's a great question. And I'll team up again with Rajeev to answer this question. But I think a lot of our answer is going to be predicated on the fact that it's formulation-driven. It's actually the PRINT formula [indiscernible] product that allows the use of low resistance device. Rajeev you can speak to kind of how the formulation leaves that [indiscernible] combination that benefit uniquely ports.

Yes, [ excellent ] question. I think to highlight what Roger has noted, the innovative technology for these drug particles that require almost no agglomeration. And what that means is that YUTREPIA does not have to overcome such barriers. The PRINT powder has already [indiscernible] to its own. The particles have already been sized, [ deposit ] deep in the lung. And a low resistance inhaler device is obviously the most suitable [indiscernible] for our PRINT technology. And by already -- by optimizing the size and shape of these drug particles, the PRINT eventually enables a more ideal dry powder experience across a broad range of inspiratory flow rates. And this is a effectively, the simplest [indiscernible] is probably one of the key reasons that there's growing excitement to bring YUTREPIA into the market, into PH-ILD patients.

Thank you, Rajeev. So I think, again, it's the formulation that is [indiscernible] have the ability to use [indiscernible] would be differentiated to delivery platform, without need to agglomerate with the higher resistance device, this will take more [indiscernible] capacity to do that, and we think that then can be certain [indiscernible] limitation there [ to ] have a leading entry into the market.

[Operator Instructions] Our next question will come from Julian Harrison of BTIG.

I'm wondering if sotatercept has any bearing on the DPI treprostinil market opportunity in your mind?

Yes. Great question, Julian. And again, I'll tag team with Rajeev. So I think, first, let's just say it's an exciting time in pulmonary hypertension, new mechanisms, new [indiscernible], new fits, part on to triple-net [indiscernible] is impressive. And I think there's generally growing excitement including our own around on how we [ interplay ] with these new modalities. [indiscernible] that I've been in this field for 30-plus years and every time a treatment has come in, there's been a [indiscernible] to replace previous methodologies or treatments. It's never ever been [indiscernible] therapy period. And I see this [indiscernible] as add-on to other therapies, the best benefit is in prostacyclin. In those patients, the prostacyclin dose was held steady because they were testing the test patients. And I think it would be exciting now to see what happened with YUTREPIA and sotatercept in combination wherever it could also be titrated [ to relieve ] the patients specifically. So again, a lot of excitement, I think, it really changed the [indiscernible] opportunities with YUTREPIA. We still think the [indiscernible] will be the first choice [indiscernible] changing option. We can capture a significant share of a market which has plenty of opportunity for building another drug, but obviously, other inhaled [indiscernible]. We're excited about process [indiscernible] in my belief it will be [indiscernible] and they're the only drug that can be titrated to effect. And given that, [indiscernible] so likely that will be [indiscernible] approval. Rajeev, I don't know if you have anything to add to that?

Julian, Roger said it excellently. I'll just add, remember one of the key issues here is also focused on not only pulmonary arterial hypertension, but also specifically pulmonary hypertension associated with interstitial lung disease, where sotatercept has yet not just shown a benefit. And so we'll all -- the entirety of both populations will be important and we're [indiscernible] to have driven or [indiscernible] in both [indiscernible].

Our next question will come from Matt Kaplan of Ladenburg Thalmann.

Just a couple of questions, on following up on the PH-ILD opportunity. I guess, one, could you tell us a little bit about the approval pathway for PH-ILD? And then secondly, with your planned open-label study, what are some of the end points you're going to look at there? And is there an opportunity to showcase a potential improvement in efficacy due to the titratability?

Thanks, Matt. Thank you it's [indiscernible]. So I'll talk about pathway. So as we've said before, we've confirmed with the FDA in writing no additional studies are required for approval for PH-ILD patients. Having said that, obviously, we can't seek approval in the market exclusivity expired in [indiscernible]. So [indiscernible] for that market post that date. So that's the path some of kind of how we are provided approval will depend on the resolution of the legal case and when we get approval for pulmonary arterial hypertension and move our tenant of approval to full approval. But in general, those are the parameters that are gating for PH-ILD. And maybe, Rajeev, if you could speak a little bit [indiscernible].

[indiscernible] So first of all, as we just discussed on this call, this will be an open study specifically in PH-ILD. So in that regard, one of the major focus is to really understand the tolerability of the YUTREPIA in patient population. Remember, this is about range of patients with different types of heterogenous [indiscernible] lung disease. So really highlighting the [ experience ] in that broad range population, and see if there's any particular population that stands out with the best response. The second thing is that we're going to be focusing titratability. We know that if conditions keep certain breath equivalent to [indiscernible] we're taking to have a better response. We want to see if: Number one, we can absolutely reach those levels and more importantly, exceed those levels in a tolerable fashion. This will translate into several data that we can acquire, including typical data points such as improved walk capacity or a 6-minute walk distance. We can also look at various effects, not only on the right ventricle itself, using [indiscernible] parameters [indiscernible], but also changes in scoring of the actual fibrosis [indiscernible] again, using noninvasive imaging [indiscernible]. So more to come on that as the final protocol [indiscernible].

I see there are no further questions in the queue. I would now like to turn the conference back to Roger Jeffs for closing remarks.

If we can let Matt back in.

Chris, Matt had one more question. Could you let him back in so he can ask it.

One moment please. Mr. Kaplan, you are now able to ask your next question.

Great. Just a quick question. In terms of -- with the moving parts associated with the Hatch-Waxman litigation and the PTAB decisions, what's your current thoughts on the timing for full approval now?

Yes. Great question. Maybe I'll ask Rusty to opine on some of the -- how he sees the timeline for the legal situation playing out.

Sure. So thanks for the question, Matt. So we really have 2 separate opportunities to get clear of the patents at this point: The appeal of the Hatch-Waxman decision; and the appeal of the '793 IPR and both of those are on different time lines. So first is the appeal of the Hatch-Waxman decision. As I noted earlier, briefing is now complete, and we're just waiting on the court to set in oral argument dates. We think that date will be some time in the second quarter or third quarter of this year. And once oral argument has been held, we expect a decision could come in as quickly as a few days after a oral argument or it could take a couple of months depending on whether we get some reaffirmance or not. And so if in that decision, the '066, the district court's decision regarding the 'O66 patent is upheld, and if the '793 decision of the district court is overturned, we would be able to proceed immediately to seek full approval after that. So that would put it sometime in the second, third and fourth quarter this year. Alternatively, if that appeal results in the 'O66 patent decision being upheld, and the '793 decision of the district court being upheld, then we would have to wait for the IPR appeal to play out. And as we noted, we expect that oral argument in that will likely be held some time in fourth quarter of this year, or first quarter of next year, or first half of next year. And again, same thing after that oral argument is we could get a decision as quickly as a few days afterwards or as long as a few months afterwards.

Thank you, Rusty. Very clear.

One moment please. And I see no further questions at this time in the queue. I will turn the call back to Roger Jeffs for closing remarks.

Great. And firstly, I say, we appreciate everybody calling in and listening. I hope you share the excitement we have around our building momentum. We're really trying to build on the back of some very positive news as it related to the legal situation. And as we continue to go to the market, you can hear our excitement around the product capabilities of YUTREPIA and how it could be introduced uniquely into the marketplace and benefit patients in a differentiated way. We thank you again for joining us, and we look forward to reporting on our continued progress in the coming quarters. Thank you, everyone. Bye-bye.

This concludes today's conference call. Thank you all for participating. You may now disconnect, and have a pleasant day.