Q2 2025 Avadel Pharmaceuticals PLC Earnings Call

Greetings and welcome to aidel pharmaceutical second quarter 2025 earnings call at this time, all participants are in a listen-only mode. A companies accompanying slides for this. Call can be found on Avid investor relations website. My question and answer session will follow the formal presentation to ask a question during this session, you will need to press star 1, 1 on your telephone. You will then hear an automated message. Advising your hand is raised to withdraw your question. Please press star 1 1 again, please be advised. That today's conference is being recorded. I would now like to turn the conference over to your first Speaker. Austin myrta with Precision AQ. You may begin

Good morning and thank you for joining us on our conference call to discuss aidel second quarter, 2025 earnings.

As a reminder, the following presentation includes several matters that constitute forward-looking statements within the meaning of the private Securities. Litigation Reform, Act of 1995.

We're looking statements are subject to risks and uncertainties that could cause actual results to differ, materially from those contemplated. In such forward-looking statements, these risks and uncertainties are described in avid's. Public filings. Under the exchange exchange act included in the form 10K for the year. Ended December 31st 2024, which was filed, March, 3rd, 2025, and subsequent SEC filings.

Officer and Tom McHugh, Chief Financial Officer.

I'll turn the call over to Greg.

Welcome, everyone, and thank you for joining us to discuss Avadel Pharmaceuticals PLC's second quarter 2025 results.

Following my opening remarks, Susan will provide an update on our continued commercial progress.

Tom will review our financial results and I will conclude with a Q&A Q&A session.

We are incredibly pleased with the results we achieved in the second quarter, including growing patient demand with 3,100 active patients on Loom Rise as of June 30th, a 63% increase compared to the second quarter of last year.

Generating 68.1 million in Loom. R, net revenue.

And a 64% year-over-year increase and delivering quarter over quarter Improvement. In key patient, metrics, including persistency percent of reimburse, patients on therapy and patient. Mix.

Additionally, the second quarter marked our eighth consecutive quarter where we added new patients from all 3 patient segments.

We expanded use from repeat Loom rice, prescribers and added new prescribers, both activated experienced and those who previously, never prescribed, an oxybate.

Which underscores how Loom rise is not only competing in the activate Market. It is also expanding it.

We also achieved important Financial milestones, in the second quarter.

As we generated 15 million in cash and for the first time, since launch net income of nearly $10 million resulting in earnings per share of 10 cents.

Given the positive momentum and improving Trends in the first half of 2025. We are raising our full year 2025 Revenue, guidance to 265 to 275 million, reflecting our confidence. And our continued commercial execution. Combined with the positive impact, the Investments we've made are having

additionally to further support Loom R's, future growth opportunity.

Based on the positive return, we have seen to date.

With our incremental, Investments coupled with Susan's leadership and insights. We continue to identify new areas for targeted Investments. We Believe can further Propel patient demand for Loom rise and expand patients on therapy.

Susan will discuss these Dynamics shortly.

We are pleased. Our 2025 launch Investments are yielding tangible improvements as Loom rice, uptake remains robust patient. Persistence continues to improve while new patient starts are occurring more efficiently and being reimbursed at a higher rate.

Furthermore, Loom Rises novel extended release profile provides additional significant growth opportunities with potential expanded indications across other hypersomnia disorders.

Specifically based on physician and patient insights. We continue to be excited about Loom Rises significant potential in idiopathic hypersomnia or IH and view this. If successful as a meaningful opportunity to amplify Loom Rises potential positive impact on even more patients.

To recap our progress on IH.

In June, we received orphan drug designation from the FDA for Loom, resses use in IH on the hypothesis. That Loom rice may be clinically Superior to current approved therapies, and provide a major contribution to Patient Care due to its once nightly dosing regimen,

Specifically FDA stated for the third time, lumines May provide a major contribution to Patient Care due to its 1. Slightly dosing for patients with IH a chronic sleep disorder. That requires potentially lifelong treatment.

This is an important milestone for us.

As the unmet medical need in IH remains high with approximately 42,000 diagnosed patients.

Limited to a single FDA approved. First generation, oxamate therapy, that is currently only reaching approximately 11% of that population.

If approved for use in IH, luminights could potentially enable eligible patients to experience an extended release. Oxamate treatment for the first time, providing an important benefit for this population, that struggles. So significantly with sleep inertia,

By offering an Innovative novel therapeutic option. That is specifically designed for the patient to receive a full therapeutic dose night after night with the added benefit of no forced Awakenings. We Believe can Elevate the standard of care in IH, and potentially unlock the significant expanded oxamate Market opportunity for Loom rice.

That said enrollment in our phase 3 revitalized trial evaluating Loom rise in IHS ongoing and enrolling patients at approximately 40, leading us Sleep Centers.

Well, on our way to completing enrollment in revitalized by the end of 2025, followed by data readout in 2026 to support a potential future, supplemental, NDA filing during the second half of 2026.

If approved We Believe Loom rights could transfer the treatment of IH, improve care for patients and further demonstrate its clinical and Commercial potential in idiopathic hypersomnia.

in addition, to the pursuit of the IH indication,

We can continue to advance our efforts on the potential to expand our oxamate portfolio to include an extended release formulation. Providing a 1 set bedtime dosing regimen with a low or no sodium profile.

The target product profile, for this formulation program continues to be bioequivalent to loom rice.

We believe that offering this expanded oxybate portfolio option could serve as an additional complimentary treatment option that addresses the potential needs of all eligible patients suffering from our approved indications.

Who deserve the proven efficacy of a consistent full therapeutic occupy treatment night after night with a 1 set bedtime dosing regimen. Providing the potential added benefit of uninterrupted sleep.

Our continued investment in this strategy is reflected in part by our increase, in operating expenses and related guidance for the second half of 2025.

We currently expect to provide an update on this program by year-end.

Now touching briefly on our litigation in June. We were pleased with that. The US court of appeals unanimously affirmed, a prior decision in favor of the FDA in a suit brought by Jazz Pharmaceuticals.

The appeals court ruling removes, any doubt that lumary will remain available for narcolepsy. Patients and affirmed, the fda's determination that extended release Loom rise is clinically Superior to all first generation immediate release activates and that it's once at bedtime dosing provides a major contribution to Patient Care.

In addition, to this important Court Victory, we're actively pursuing additional legal actions, against Jazz to protect our rights and intellectual property, including but not limited to our antitrust case, which is currently scheduled for a jury trial. Beginning on November 3rd of this year.

Whereby, we are seeking total potential recovery in excess of 1 billion dollars.

We are incurring.

Encouraged by the progress made across all aspects of our business. And in particular, the execution of our commercial team, which is driving the strong performance of our Loom rise narcolepsy franchise.

This combined with the work we are doing to expand potential future patient populations who could possibly benefit from Loom rise, along with our continued progress, on the litigation front sets us up for a strong, second half of 2025, and continued, positive, momentum, and growth into the future.

With that, I'll now turn the call over to Susan for details on our commercial developments Susan.

Thank you, Greg. Before I begin, I would like to thank the aidel team for providing me with the opportunity to lead. This impressive, commercial organization and work together to transform the lives of patients, living the type of personia disorders via Innovative sleep technology.

Our second quarter marks, nearly 2 years of low Rises, availability on the market. And our performance represented by the roughly 3,100 patients. Now on therapy reflects the robustness of our commercial foundation and the value Next Generation Loom right brings to patients with narcolepsy.

The impact of our launch. Can also be seen in the behavior of loom, rice, prescribers, since launch. We have seen hcps who prescribe Loom rice, for the first time demonstrate a rapid adoption of blue rice highlighting the drugs favorable profile and ability to treat patients in need of a new option.

Despite being on first generation octaves.

Hcp's proceed to increasingly select Loom rise, as their octave choice, and expand their prescribing to previously discontinued and new to ocupate patients. In addition to switch patients

A growing number of oxidate. Writers are becoming Loom rice, writers and are persistently expanding their use across all 3 patient types.

Additionally, we're seeing writers who do have not historically written for us to be prescribed Loom, right?

The impact we are making across the narcolepsy. Treatment Paradigm is appearing in the real world comparable to what has been presented in the literature as more. And more patients are reporting, positive blue rise experiences back to their hcp. This is consistent with the results captured in the open label phase 3 extension switched restore study where among the switch participants

That preferred Loom right over the older Ops debates and 91% reported easier adherence to the medication schedule for Loomer.

It is clear that the novel option of, once at bedtime dosing of a full therapeutic, dose is driving robust patient, uptake and favorable treatment experience, with loom rice.

Additionally, our commercial focus and execution including our additional 2025 commercial Investments. Our further amplify our success in particular, our expanded investment to optimize the region frequency of office and patient services to our growing prescriber base. Has further accelerated uptake and is driving favorable enrollment conversion rate to reimburse, patient starts and patient persistency improvements.

Further our direct to Patient efforts combined with hcp's growing Comfort level with loom. Rice are driving patient requests for Loom rice and new enrollments.

As such we are.

Expanding our investment in these programs. And the second half of 2025 to leverage this opportunity.

And further fuel growth momentum.

As commercial Investments like these proved out and continue to catalyze. Our launch, we are pleased to leverage, our learnings and invest in the launch even more. So as an example, we're further expanding our sales force to 60 representatives to support our continued. Focus on the growing provider base and to optimize reach and frequency to gain additional new prescribers.

Additionally, we are increasing our investment in key ACP and patient centered programs.

Based on the positive insights and return. We've experienced in the first half of 2025.

Before I turn it over to Tom, I want to highlight our presence at the fleet, 2025 meeting where we hosted multiple oral presentations and published more than a dozen abstracts. Our team had a productive team in Seattle, connecting with the broader sleeve Community across all levels, scientific clinical and Commercial

In summary Q2 was a strong quarter for avido, reflecting Loom raises advancing Market positions across the ocupate space. We will continue to drive our Promotional and operational execution. Intensity to capitalize on this momentum and maximize the potential for Loom rights with that. Let me turn the call over to Tom to walk through our Q2 Financial results.

Thanks Susan.

Before I begin, please note the full Financial results are available in the press release issued this morning and the 10 Q.

I will also be referencing non-gaap Financial results which can be found on our, on our investment relations website at investors aidel cam.

There are a number of positive Financial results to report to the second quarter and I'll start with an update to revenue guidance.

We are raising fully your guidance to 265 to 275 million from prior. Guidance of 2505 to 265 million. Which reflects our confidence in the continued growth of the Loom rise.

The expected generates 71 to 75 million in net revenue in the third quarter, which is the midpoint represents a 46% increase over the prior year.

We believe we have clear visibility to deliver on the updated guidance, which is based on the favorable Trends in the first half of 2025, including growing patient, demand and improvements in key patient metrics such as persistency and patient mix.

We expect these improvements to continue and are reflected in our expectations for second half Revenue contribution.

In terms of topline results for the quarter ending June 30, 2025, net revenue was $68.1 million, reflecting sequential growth of 30% versus Q1 and 64% compared to the same period last year.

Gross profit was $61.8 million, reflecting sequential growth of 32% versus Q1 and 60% compared to the same period last year.

I'll also note that gross profit in the current year, includes a non-cash adjustment and cost of goods. Sold for a potential 3.5% royalty on loom Rice, net revenue related to the Delaware Court memorandum, and opinion issued in September of 2024.

A ruling from the Delaware court regarding a future ongoing royalty rate is pending and while we intend to appeal the underlying jury decision regarding the validity of the patent.

From an accounting standpoint. We have included an approval and cost of goods sold.

Turning to operating expenses total Gap. Operating expenses for the second quarter were 52.9 million versus 51.5 million in the prior year.

The current quarter includes 6.1 million of non-cash charges.

And after adjusting, for these cash, operating expenses for the quarter were 46.8 million.

Second half of 2025, given the successful results from the loom rise Investments made at the start of start of the year.

We're making further investments in our sales force, and direct a patient and physician marketing programs to continue propelling patient demand.

We are also continuing our investments in the low or no setting. Extended release formulation.

We currently expect the cash operating expenses in the third quarter will be in the range of 50, to 55 million, and non-cash expenses within the range of 6 to 80 million.

The respective operating income. The second quarter.

Marks the fourth consecutive quarter of positive operating income as adjusted for the company.

Adjusted operating income. Calculated. His gross profit of 61.8 million minus cash. Operating expenses of 46.8 million was 15 million.

As patients on therapy, continue to increase. We expect incremental Revenue complemented by a highly leverageable cost structure to increasingly flow through to operating income.

And turn into the bottom line.

The quarter ended, June 30th 2025 marks. The first time, the company has generated net income, since numerous was launched,

That didn't come for the quarter was 9.7 million or 10 cents per diluted share.

Compared to net loss of 13.8 million or 14 cents per diluted, share for the same period in 2024.

In the current quarter includes a 3.2 million non-cash. Tax benefit, resulting from a change in estimated tax liabilities

now concluded with a few comments on cash and cash flow.

We generated 15 million of cash during the second quarter and ended the quarter with 81.5 million of cash, cash, equivalents and marketable securities.

We Believe cash on hand and our expectations of sustainable positive, cash flow provides ample Runway to fund our commercial plans and the IAS clinical program

With that, I'll turn the call back to great for closing remarks. Thank you Tom.

Before we open the call for Q&A, I'd like to summarize the opportunities We Believe can unlock value for Aveda when 2025 and Beyond.

First activate Market momentum behind Loom Rises, strong.

With our commercial investments, accelerating our impact and further advancing LoomRise's pursuit of being the oxidative choice.

We delivered strong results during the first half of 2025 and expect, continued, execution, and growth throughout the remainder of the Year, supported by targeted investments in the commercialization of Bloom runs.

We are well positioned to generate sustainable cash flow based on the trends we are seeing, which is further underscored by our highly leverageable cost structure and our increased 2025 revenue guidance.

We're pursuing opportunities to maximize the potential of our unique ones at bedtime, formulation with pursuit of an expanded indication in idiopathic hypersomnia, and are confident in our team's ability to turn their promise of our Innovative science into reality that could possibly benefit. Even more eligible patients,

And finally underpinning our progress lies our robust and growing intellectual property portfolio that protects Loom rise and its unique Innovation until 2042.

This Innovation and the oxamate market potential of Bloom rise are foundational, strengths we will continue to protect and defend as we advance toward the currently scheduled antitrust jury trial which is set to begin in just under 3 months.

As always, we thank you for your time and your continued support. We will now open the line for Q&A, operator.

Thank you. As a reminder, to ask a question, please press star, 1, 1, 1 on your telephone, and wait for your name to be announced to withdraw your question. Please press star 1 again and stand by while we compile our Q&A roster.

Our first question is going to come from the line of Andrew tie with Jeffrey. Is your line is open, please go ahead.

Hey, good morning. Congrats on the execution and heading profitability and thanks for taking my questions. So, um, first question on the overall guidance raise, uh, it looks like it imply. It does imply, Q3 Q4 will certainly grow, but maybe moderate a little bit compared to Q2 over q1. Is it because uh, your guidance is conservative? Or is it because, you know, maybe Q only seasonally we saw hence a strong Q2 or Q3 Q4 have some kind of seasonality as well. So some color around the, the quarter early trajectory would be helpful behind the guidance.

Yeah. Thanks Andrew for the question. I I think as we look forward and on the backs of what we've learned in the first half in the progress, we've made the number of areas when we think about the guide, um, you know, we we have to add more patience. We have to continue to grow patience to be able to achieve, to to achieve the even the low end of the guide from that perspective. So,

You know, persistency or you know, percent reimburse all continue to perform at or better levels um than what we've seen in the first half. So our guide is based upon on on those metrics, um, you know, sustaining themselves and improving. And if they do better, then, you know, then then what we're currently projecting. Will have an opportunity to revisit that in the future.

And Andreas Tom just as a follow-up. You know we always take a very thoughtful approach to the guys to provide and you know and and how it can be how it can be seen. So if you you know are looking at a second half of the year as evidence of durability of the Investments we made in the first half of the Year particularly in the first quarter and always, you know, never forget of course that you know, going from q1 to Q2 you get a Lyft from the gross. Net impact from q1. So, we're going to get a Lyft from q1 to Q2 just as a result of that.

Thank you and uh second question follow up is uh would you be willing to share how many uh patients initiated therapy during Q2? I think that can help us determine the intra quarter dropout rate. Um, and going forward, would you expect that intra quarter dropout rate to decline further or stabilized from here? And would that be driven by, you know, more patient education or more oxidate switch patients? Entering your overall mix. Thank you. Yeah, inherent in your question. Andrew. Thank you is, you know, how are things happening on on a persistent day basis? You know, the the primary kpis, we'll talk about will be, you know, uh, patience.

Therapy at the end of the quarter and therefore, solving for net patient ads, and of course, Revenue in terms of the progress. We've we've seen in Q2 versus q1, we are very pleased in q1. In terms of the, what we would describe as almost the immediate impact of the interventions. We deployed around persistency and that that progress in q1 continued into Q2. And we saw some, some improvements in Q2, as well as we go forward, our assumptions. Are that, that, that, that that, that progress is durable and the opportunity to improve it is, is less dependent upon make patient mix. Although we've seen an improvement in patient mix as well, um, because we've had such success in terms of impacting persistency during the first half of the year and it's really more about executing and continue to get even more tailored and specific to each individual patient to help them, you know, on their Journey on loom rise, all of which we've seen, you know, positive Trends and durable Trends so far through the first half of the year.

Great. Thanks for the caller now that we you know, turned the quarter on profitability. You know every patient you know regardless of type is going to contribute to the bottom line.

Thank you. And 1 moment for our next question.

Our next question comes from the line of Amya fadia with needam and Company. Your line is open, please go ahead.

Good morning. Thanks for taking my question and congratulations on the nice execution. In the first half of the year. Um, I have a few quick questions on the second quarter, reported number. Um, could you give us a sense of what the

Um, implied annual price that was realized in the second quarter was and if there was any change in uh, inventory stocking, that impacted the quarter, and then I have a question on the guidance.

Yeah. So Amy um in in terms of the annualized, net revenue per patient, you know, we just work through the math and never revenue and you know, the number of patients we've reported on therapy.

On, uh, it works out to about 92,000 annualized per year.

Um, clearly an improvement over q1. And again, I refer back to the gross net Improvement that we get, um, you know, had if you wanted to, you know, head if you wanted to Q2

And in terms of your question on inventory stock and it was really no impact, uh, you know, a quarter of a quarter is it is a, you know, something we monitor, uh, you know, quite frequently, but it was really no impact on Revenue quarter of a quarter result of inventory stock almost. Yeah, the only thing I would add to Tom's comments on Price is that, you know, the the the nice uplift in price we've seen wasn't you know solely based on that gross to net the execution of the the the initiatives. We um you know we delivered

And and executed on the first half of the year have contributed to um to to that to that Improvement as well. Which again, we believe is, is has demonstrated durability in Q2. And, and, and so far in the early parts of Q3

Understood. Okay. And then with regards to the guidance,

what is your implied? Um, you know, maybe at the low end or the midpoint of the guidance, uh, how many patients on treatment? Are you assuming by the end of the year? And if you could give us a sense of where you see the net price evolves uh by the end of the year,

thank you.

Looking more granularly at Q3. Let's set the low end, you know, you know we we we do support durability and the improvements we made in the Investments we made sticking throughout the quarter. So at the low end it implies you know about the same level of net patient ads from that we saw in Q2. But clearly with an opportunity for improvement, as we continue focusing, all the patient metrics, not just net patient ads, but also persistency, you know, compliance and a number of other things.

Thanks and any thought on price.

I'm sorry. What was the question? Yeah, I think when you think about price through the balance of the second half, I think we're at a place now. That's probably a reasonable proxy. As we go forward from here. We've gotten the the uh, at least as a baseline. We've gotten the benefit of the gross to net Evolution and from T1 to Q2 and we believe the progress we've made on other aspects of our of our execution are durable to our our net price and and and obviously the opportunities we're focused on the try to make that better. So but for now, we feel good about where, where where the net price is today and again clearly you get the lift from q1 and Q2. Um, I have to you know Greg's comment that I think I would for lack of a better term. I mean I described a steady state you know from coming off the Q2 and the range of the year.

All right, thank you so much.

Thanks Amy.

Thank you. And one moment for our next question.

Our next question comes from the line of David amson with Piper Sandler. Your line is open. Please go ahead.

Um, hey thanks so 2 for me. Uh, 1 is, can you talk about how you're thinking about the impact of the orexin longer term on, um, on your narcolepsy? Um, business, um and then secondly, um, regarding iiah. Um, do you anticipate a significant switch Market from zywave to Loomis or do you think ultimately, you can grow the pie? Um, overall thanks

Yeah, David thanks. Uh on your first question relative to direct since it's obviously something you know we continue to spend a lot of time on to understand and and and really

Primarily through discussing and engaging with, with Physicians and clinicians, both key opinion leaders.

As well as the community and academic based prescribers, right? And I think there's been a number of themes that have emerged for us, in, in, in pretty extensive work. We've done trying to assess this. This landscape, this erectin, if you will hypersomnia landscape, I think relative to octaves the most important things that we've heard from clinicians is Mo that that activates play an important role and will continue to play important role. Now in the future, narcolepsy is a 24-hour condition and the night time related symptoms booked today and in the future need to be addressed

Um, from that standpoint and only activates have proven to be able to do that with a, you know, durably for, you know, nearly 2 decades now. And, you know, from that standpoint, I would say when it comes to the role of erections and activates, you know, physician feedback to us, would say they see it as more complimentary, um, from that standpoint and the opportunity to potentially use an erection with an occupy, could could emerge as a new standard of care in the future. But there's equally questions that remain on erections as well. Given the data still pretty new and, and, and it's an evolving data set for sure. Over the next number of years that there that in some cases, may not really real, you know, materialize until it's in the real world. But I think in terms of where we see the future, we believe based upon physician insights that occupy have an important role today. We'll continue to have that important role to treat the nighttime and and as a an important um, treatment option for patients and and that Loom rice is well positioned. In this regard to be both a standalone treatment option.

Or potential complimentary treatment option with some of these emerging new Therapies.

In terms of your question on IH, you know, today, you know, you know, just a little over 10% of the diagnosed, if you will patients under care are being treated by, um, being treated by uh, the, the only improved ocupate and the only approved product for our age at this point, in our view, we we see a much larger Green Field than that for us. We think the opportunity to grow the pie is real and substantial and and, you know, that's where

That's how we view, you know, the IH potential for us, not through the lens of what what what limited number of patients have been treated to date, but how many patients really need to be treated and that's the opportunity for Loom runs.

Thank you. And 1 moment for our next question.

Our next question is going to come from the line of Mark Goodman with the rank Partners. Your line is open. Please go ahead.

Changed. Um, I know you've talked about, you know, the 3 buckets of where you expected to get patients and stuff, you know, I'm, I'm actually referring to, you know, more of what what you've seen, obviously you know, Jazz has reported, you know, harmonies reported. You have a good sense of what the market looks like. So, what what, what's going on out there and just give us a sense of growth and stuff.

Yeah, I mean, I I, I think when we think about, you know, the ocupate market in this particular Loom ride, we can point the very specific, very specific data points. That help us that the market through our lens is growing, right, we don't have complete visibility to every product and every product's use in the category, but but clearly, you know, there's a lot of, uh, promotional efforts going on in the, in the category and, and that drives higher diagnosis rates that drive more awareness, that drives, you know, more patients potentially in to be treated. And that's, you know, a good thing for patients and it's a good thing for the market from that perspective. But whether you're looking at it in the context of every quarter, adding a prescriber who didn't previously run an activity or treating patients who have been off of an oxybate for quite some time. But have decided to come back in because of the Loom rice is availability. These are all really good signs for us. That the market, at least through the lens of what Loomis is offering is bringing new and more patients in relative to um to what's been their history.

Historic, I don't know. Susan, if there's anything you would like to add to that.

Yeah, no, um exactly. And overall from a perspective,

Well, I guess I guess just as part of the question, you know, obviously, when you first launched it really felt like there was an expansion of the market going on a number of patients, I was just curious. If you still felt like, you know, a lot of like what what what's your best expected, you know, oxidate number of patients growth rate for this year is I mean we talked in 2 3 or we talk in 5 6%,

Yeah, I I think being that precise is is not so important to us because we don't see what's happening with some of the data around the AG, or or the original first generation activates from that standpoint. What we see is where we're sourcing business from and what that means in terms of the pie, if you will that we're we're grabbing share from and grabbing, you know, you know, starting new pages on their be and all that gives us, you know, confidence that blue lights is attracting and bringing patients into the market that haven't been in either ever or haven't been in quite some time. Exactly. And just since launch quarterly persistently, we've identified new prescribers that historically have not been activated writers. So there's clearly an opportunity given the profile of 1, right for pace for Physicians, who treat a lot of narcolepsy patients. But having this

Lye used to activate to adopt 1, right? And what we're hearing from those positions. And we speak to them is that the, the, the simplification of the dosing profile, really gives the HTTP the opportunity to initiate activate therapy with their patients. So, there's clearly opportunity there. We've seen it persistently since launch and we, you know, we anticipate continuing to draw from that group.

Thanks.

Thanks Mark.

Our next question comes from online of Ash, Burma with UBS, your line is open, please go ahead.

Hey, good morning. This is the on behalf of Ash and congrats on the quarters. Um, I have 2 questions on antitrust case. If I met the first 1, how do you establish establish the time period that you were unable to enter the market as 1 half year as claim? Uh there were uh I think there were multiple factors that play Beyond just the proper listing of competitors ramp patterns, are you are you confident in the 1 half year time window or can it be shorter?

Um my second question is we did not see any resolution uh based off the summary document Motion in June. So what do you uh what do you make of that development? Thank you.

Yeah. Um thanks for the question when it when it comes to. You know, those specific matters relative to any litigation, we're just not going to comment on it at this point. Um um but I appreciate the questions and and all of that will become more clear in uh under 3 months.

All right. Thank you.

Thank you. 1 moment for our next.

Our next question comes from the line of ragam Silvera with HC rain rate. Your line is open. Please go ahead.

Versus, uh, you know, the, uh, the, the market in which the product is currently labeled and, uh, how how you are viewing, the principal differences between these 2 indications. Uh, you know, from a promotional strategy perspective. And if you give us a sense of whether there are likely to be differences in marketing strategy, as you position the product in this future new indication,

Yeah, thanks for the question, I think. So, maybe I'll make a couple comments and then and then turn it over to the expert. Um, who are really fortunate to have her on our team. Um, you know, I think as we think about,

You know, the 2 different patient types, so to speak, where you have narcotic patients who generally have a hard time, staying away versus, you know, IH patients, who have a hard time waking up there. It's very different uh, matters that we have to deal with from that perspective and and the and the value proposition of Bloom, right? Um, you know is is, is we believe, uh, if again, if if approved, then all the things that we're doing on IH, pan out, you know, will will be an important treatment option for them. I think, from a, you know, what's our go to market strategy? You know, we'll talk about more that and much more in the future when those things, you know, when the time is right for that and appropriate for that. But I think most importantly in this regard is that, you know, there's a lot of, you know, Synergy if you will or a lot of overlap in terms of the same prescribers, you know, the same sleep specialists, who are treating

You know, they're treating hypersomnia disorders you know in totality and you know IH is 1 of them for sure. So um I'm I'm you know Susan can certainly provide more context, you know as appropriate but appreciate the question, there'll be more to talk about that in the future.

Yeah, I would just add. As Greg mentioned, there's really a, a, a very large overlap, in terms of the Sleep specialist who see, who are currently treating in America, who will become our targets, uh, with with the launch of the IH indication. And what's really notable, is that today, um, we're seeing this

Incredible momentum and driving, you know?

Increased uptake of loom rights across these exact, you know, High narcolepsy patient, doctors and what they report back to us in terms of the reason for their expanded adoption across, not just switch patients but new patients. And previously discontinued patients is the value of the extended release profile of loom. Write the value of the extended release technology platform that human rights brings to the market which enables once at that time. Dosing for a full therapeutic dose. That's the reason you know product profile standpoint that's what's driving the growth momentum today in narcolepsy and that very profile is extremely valuable um, to a to achieve your treatment objectives for an IH patient. So we will definitely have a running Head. Start in terms of familiarity of to fit for Loom rice, given its profile um in the IH patient population and we will customize our marketing and promote

Approach to really um Drive expansion of that market identify IH patients and and any you know, leveraging the profile that Loom rice brings to actually treat those patients which today are going. Broadly, untreated

and just 1 other quick 1. If I may if you're looking ahead to The Sleep conference and in particular, what data might be presented with respect to the orexin pathway modulators uh at that event. Do you think that there may or may not be any information presented at that conference that might uh, alter the competitive landscape Dynamics picture,

Uh, you know, I think everyone's, uh, looking forward to World sweep and and seeing more details on both the phase 3 and Phase 2 data that, you know, have at least provided kind of high level Topline data. So far from that perspective and I think we'll be more equipped to answer that question, you know, in the future, um, we we we've done our research and continue to do our research on on this, uh, landscape. If you will. Um, even very recently in the last couple of weeks talking to dozens and dozens of Physicians, you know, post the the high, the Topline readout of some of the data. And we're, we're drawing our insights, and our perspective based upon kind of real time off the real data. And we'll continue to do that over time and and and have us help. Think through what all this may mean. But you know, the 1 thing that's been consistent as we've been working on this for the last number of quarters.

Is that the role of October 8th is important and will continue to be important. Now, and in the future,

Thank you very much.

Thank you. And

Our next question.

Our next question comes from the line of David Hoang with Deutsche Bank. Your line is open, please go ahead.

Uh so I I had 2 first. Um, could you comment on the I guess the current mix of switch patients and naive patients. Is that still a focus for you and and where would you like to see that mixed Trend, um, over the next few quarters and then with your increased investment in the launch? Uh, can you just talk a little bit more about? What exactly your hoping to achieve with the prescribers? And um, is increasing the depth or the breadth of prescribing more important? Thanks.

Thanks, David Susan. Yeah. So today is we look at our total patients on therapy. Um, over half of them are switch patients. And we're actually quite encouraged with the whole adoption cycle. Um, across our prescriber base for rapidly, growing our prescriber base. And what we found is that it's quite consistent in terms of how they adapt blue ride starting with patients, that are on treatment that they have been in need of new options. So we get some switch patients, very early in the adopt cycle. And then what we're finding is that with their favorable experience at Loom, right? They're rapidly expanding to new to October, they discontinued patients and then um, and then continuing to actually adopt blue rice for at switch patients because they identified that patients that they thought may have been effectively, managed. In fact, could be doing a lot better. As they're seeing patients come back with their experience on human rights. So we are in a really, really positive steady state in terms of this adoption cycle, where, as we grow our prescriber base.

They are continuously expanding their use of the drug and the use of lumines is increasingly reflecting just their patient population in terms of who they have currently on treatment, and the new and the previously discontinued and we are drawing from all of those patient groups, which is really speaking positively to the Future for lumite, in terms of the prescriber base. Um, you know, we really have, um, captured the majority of the highest, uh, prescribers those highest volume doctors. Um, and they are adopting them right across all of their patients tonight. So what we're seeing is it's what's growing. Um, the business is the expanded use of Bloom, right? And the existing prescriber base with consistent, um, growth of new prescribers and these new prescribers are in those lower, volume offices, but they're being. So, we're really getting to all of the narcolepsy patients. And also, we are growing new prescribers of, as we had mentioned before. Um, Physicians. You see a lot of narcissistic patients, but haven't necessarily used possibly basic historically. So we're in a very good balance of

our growth coming evenly from depth of use as well as expanded writer base. And I think just to, to tap, tap into that tight, on to that, David is the Investments we're looking at, is to, you know, continue to accelerate that both at the prescriber level, but also at the patient level as well, right? And continuing our efforts in a, in a, in a, in an amped up manner, for lack of a better word in our, in our efforts to communicate and activate and educate patients. Yeah, it's not surprising when

We talked to patients, um, what they'll tell you is that they really prefer the profile and Loom, right. The, the profile of boomerang is is really quite a, a patient friendly profile. So, our direct to Patient efforts to date has really been generating new enrollment. We're increasingly hearing from https. Our research is captured this that more and more patients are coming in and asking for Loom, right? And what their, and they're happy to actually prescribe it because they're comfortable with the drug. They're comfortable with the servicing, that aidel provides the office, and the patient. They're seeing the good results. So we have some strong momentum being driven by the patient driven request, so our expanded Investments are clearly focused on leveraging that opportunity.

Thanks David.

Thank you. And 1 moment for our next question.

Our next question is going to come from the line of Chase Knickerbocker with Craig Callum. Your line is open. Please go ahead.

Good morning. Uh congrats on the quarter. Uh most of my questions have been answered, but um maybe just a bigger picture one for you, Greg. Um if we kind of think about, you know, your balance sheet obviously now, um with your net cash position, and going to get stronger.

um, can you kind of speak to your guys's activity on the BD side and any sort of commentary that you're willing to give on kind of um the profile of of something you'd be willing to look at whether that's something that's, you know, mid or late stage clinical or whether or not you'd be more interested in kind of leveraging your your commercial um,

Platform, you know, immediately with some sort of commercial acquisition.

Continuation work we're doing. But we have a team that you know, that that evaluates, you know, things in the marketplace, uh for which will be very disciplined about, uh, in that regard in terms of what would what would or wouldn't be something that would make sense for Avid out, listen, our shareholders have enabled us, the opportunity to build an infrastructure and a capability to commercialize in this space. And those are the things we're focused on and that's where we should be paying our attention to primarily. As you know anything that may be, you know, inorganic from that perspective for lack of a better word, but make I I'll be very clear. Like, our focus is on accelerating the launch and and and moving our life cycle management expanded indication efforts forward as our primary priorities.

Very clear. Thank you.

Thank you. And I would now like to hand the conference back over to Craig Davis for closing remarks.

Thank you again, everyone for joining us today. And spending time, we look forward to any follow-ups and and uh have a great day. Thank you.

good, today's conference call, thank you for participating and you may now disconnect

Q2 2025 Avadel Pharmaceuticals PLC Earnings Call

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Avadel

Earnings

Q2 2025 Avadel Pharmaceuticals PLC Earnings Call

AVDL

Thursday, August 7th, 2025 at 12:30 PM

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