Avadel Pharmaceuticals plc (AVDL) Q4 2022 Earnings Call Transcript

Avadel Pharmaceuticals plc (NASDAQ:AVDL) Q4 2022 Earnings Conference Call March 30, 2023 8:30 AM ET

Company Participants

Austin Murtagh – Stern Investor Relations

Greg Divis – Chief Executive Officer

Jennifer Gudeman – Senior Vice President-Medical and Clinical Affairs

Richard Kim – Chief Commercial Officer

Tom McHugh – Chief Financial Officer

Conference Call Participants

Chris Howerton – Jefferies

Adam Evertts – LifeSci Capital

David Amsellem – Piper Sandler

Matt Kaplan – Ladenburg Thalmann

Operator

Greetings, and welcome to Avadel Pharmaceuticals Fourth Quarter and Full Year 2022 Earnings Call. [Operator Instructions] It is now my pleasure to introduce Austin Murtagh with Stern Investor Relations. Thank you. You may begin.

Austin Murtagh

Good morning. And thank you for joining us on our conference call to discuss fourth quarter 2022 earnings.

As a reminder, before we begin, the following presentation includes several matters that constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-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 include risks that products in the development stage may not achieve scientific objectives or milestones or meet stringent regulatory requirements, uncertainties regarding market entry and acceptance of products and the impact of competitive products and pricing. These and other risks are described more fully in Avadel’s public filings under the Exchange Act included in the Form 10-K for the year ended December 31, 2022, which was filed on March 29, 2023, and subsequent SEC filings. Except as required by law, Avadel undertakes no obligation to update or revise any forward-looking statements contained in this presentation to reflect new information, future events or otherwise.

On the call today are Greg Divis, Chief Executive Officer; Jennifer Gudeman, Senior Vice President of Medical and Clinical Affairs; Richard Kim, Chief Commercial Officer; and Tom McHugh, Chief Financial Officer.

At this time, I’ll turn the call over to Greg.

Greg Divis

Thank you, Austin. Good morning everyone, and thank you for joining us for a company update and to review our fourth quarter and full year 2022 results.

2023 is proving as we expect it to be a pivotal year for Avadel. We have already executed on a number of significant milestones, including the recent completion of multiple, strategic financings that pave the way for growth and value creation as we enter the final stages to bring LUMRYZ, our investigational, once-at-bedtime, oxybate therapy, for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy to the market.

Within oxybate, eligible patient community of 30,000 to 35,000 strong and the opportunity to address the most important unmet need, which requires patients to forcibly awaken in the middle of the night during a precise 90-minute window, LUMRYZ offers the potential to provide oxybate patients the opportunity to have an uninterrupted night sleep while commanding a meaningful share of the estimated $3 billion to $3.5 billion once-at-bedtime oxybate market.

I am proud of all that our team has recently accomplished, which has put us in a very strong position ahead of a potential final approval and the commercial launch of LUMRYZ.

As announced yesterday, significant progress has been made in strengthening the company’s balance sheet, providing us with the financial flexibility and a clean 10-K ahead of the potential launch of LUMRYZ to the execution of a series of strategic financings, which in total provides the company with approximately $200 million of committed capital to support a potential LUMRYZ launch and a new April, 2027 maturity date for $96.2 million of our convertible notes. The total capital includes $125 million from an equity raise and up to an additional $75 million in royalty financings with RTW Investments. RTW, our largest equity holder, continues to be incredibly supportive of Avadel and LUMRYZ and this additional royalty financing, along with the convert exchange and equity raise, provides us with the necessary resources and balance sheet to fully support the commercialization of LUMRYZ for people living with narcolepsy.

Tom will provide further details a little later in this call, but it is important to state emphatically that the completion of these financing actions puts us in a strong financial position to execute on our launch priorities and deliver on our mission to transform Avadel into a commercial organization and a major player in the narcolepsy space.

I want to thank everyone, and especially all of our investors, who have supported us during this process and your continued belief in the promise and future of Avadel and LUMRYZ.

Turning to our progress on the regulatory front, earlier this month we submitted a minor amendment to our LUMRYZ NDA requesting final FDA approval. This came shortly after the REMS Patent was delisted from the FDA’s Orange Book in response to the unanimous three to zero panel decision of the United States Court of Appeals for the Federal Circuit on February 24, affirming the previous district court ruling ordering that delisting.

Based on recent interactions with the FDA and the March 1 submission date for our minor amendment requesting final approval, FDA guidance to us would suggest timing to a decision could be around two months or approximately early May. Please note actual timing is not in our control, however, we remain committed to continuing to do all we can to try to accelerate this. If or when we learn anything more specific, we will certainly share that information as appropriate.

We also recently announced that the FDA approved our Pre-Launch Activities Importation Requests or PLAIR for LUMRYZ. This has allowed us to import LUMRYZ into the U.S. ahead of a final approval decision and puts us in a position to potentially shorten the time to product availability. With this, we expect to be in a position to have LUMRYZ available in about four weeks after a potential final approval. With a near term final approval decision and the potential for product availability shortly thereafter, we have been focused on building and preparing our organization for the potential launch of LUMRYZ. Richard will join us shortly to provide a further update on our launch preparations in progress.

And lastly and certainly not least, we continue to expand the patent exclusivity for LUMRYZ, as we have recently been granted five additional U.S. patents for a current total of 13. These 13 U.S. patents provide Orange Book-listable patent protection into early 2042 with many more applications pending at the U.S. Patent Office.

We have a lot to cover today, so with that, I will turn the call over to Jennifer for details on our recent scientific data presentations. Jennifer?

Jennifer Gudeman

Thanks, Greg. And good morning. It’s an exciting time for us. We closed out last year by presenting a total of seven posters between the American Neurological Association and the CHEST meeting. I will briefly highlight two of the posters. First, a real-world study with the Mayo Clinic to understand the top 20 comorbidities increased in people with narcolepsy compared to a matched cohort. The top 20 did not include cardiovascular disease. And second, a discrete choice experiment where among 100 clinicians and 125 patients, the most important driver of oxybate treatment choice was a single dose.

Whether it is medical congresses or individual KOL meetings, our experienced NFL team are having, we consistently see unsolicited excitement and enthusiasm for the unmet need that LUMRYZ will fulfill if approved. The robust clinical study data of LUMRYZ and the clinical value proposition of avoiding middle-of-the-night dosing is well understood.

Regarding the benefit of eliminating the middle-of-the-night dose, we supported research that was conducted by TREND Community to better understand the patient experience with twice-nightly oxybate. TREND Community submitted these data, which were accepted as a late-breaking abstract to the advances in Sleep and Circadian Science meetings held in February.

I will share a few highlights, TREND presented from their sample of 85 respondents with narcolepsy who have currently or previously taken twice-nightly oxybate therapy. Approximately 75% of the patients surveyed reported missing the second dose. Of that group, 65% shared that this happens at least monthly. Further, 32% reported suffering injuries when waking to take a second dose of therapy. Of that group, one third said, this occurs at least monthly. These new TREND data, which are consistent with what we have learned in our RESTORE study via patients switching from twice-nightly, highlight the potential positive impacts that once-nightly dosing will have on people living with narcolepsy.

Let’s turn now to the published data reporting additional safety concerns with currently available treatment regimens. In January, we published our findings in the journal, Drugs - Real World Outcomes from the FDA Adverse Event Reporting System or FAERS of reports that show patients are inadvertently taking their second dose of sodium oxybate less than 2.5 hours after their first, which can be associated with serious adverse events.

It’s relevant to consider what prompted this research. We have heard time and time again from people taking twice nightly oxybates that this happens and when it does, it can be a harrowing experience as the publication underscores.

The other consistent theme we hear is that patients don’t report this to their doctors, the FDA or the REMS program because they are fearful if they did that their therapy would no longer be accessible. It’s well recognized that adverse event reporting is the tip of the iceberg.

Reporting is voluntary for both patients and healthcare providers, and it is estimated that only about 10% of adverse events are reported. Without any other option, the reticence of patients to share these safety concerns and of clinicians to ask about potential safety concerns is not surprising.

Yet, the risks are relevant, among this sample 27% of reports where dosing was less than 2.5 hours after the first resulted in hospitalizations with another 22% associated with the use of emergency services. We look forward to providing a treatment option, we believe will mitigate this serious safety risk of taking a CNS depressants earlier than is advisable, as well as overcoming the challenges of missing the second dose and/or taking it too late.

I will now turn the call over to Richard to provide an update on the commercial opportunity and Avadel’s preparations for launch. Richard?

Richard Kim

Thanks, Jennifer, and good morning, everyone. It’s a great progress that Greg covered has allowed us to finalize our pre-commercialization activities. And today, I will share some additional market research that continues to support why we believe LUMRYZ can have a major impact in the narcolepsy market.

In addition, I’ll provide further updates on our significant launch readiness progress. With the submission of the amendment for LUMRYZ to the FDA, the imminent decision for final approval and rapidly approaching potential product availability, our commercial [indiscernible] have progressed in fairly, as we continue to progress spring [ph] once-at-bedtime LUMRYZ to the narcolepsy community.

We’ve been working diligently over the past few months to shorten window to drug availability, follow potential final approval, and this was further confirmed with the FDA recently granting our player. In this regard, we currently expect depending on the potential final approval timing to have product available in the market in approximately four weeks post-approval.

Now, in addition to the player approval, we’ve made significant progress with our REMS and patient services center, which will both be operational in advance of a final approval and our supply distribution network, which will be fully operational when the product is available.

Earlier this year, we performed new market research, which included sleep specialists with varying amounts of oxybate utilization. Here’s a few key takeaways. First, when shown the LUMRYZ product profile sleep specialists give LUMRYZ the highest oxybate market share. Now receiving the highest overall market share from this research is horribly consistent with three previous demand studies we have conducted, representing insights from hundreds of sleep specialists. Supporting this with the vast majority of sleep specialists stated that they were either likely or highly likely to prescribe LUMRYZ.

Second, with the introduction of LUMRYZ over time oxybate usage in narcolepsy patients is expected to grow by at least 50%. This is very consistent with previous research where with the introduction of once-at-bedtime LUMRYZ sleep specialty more of their patients becoming eligible and being treated with oxybate therapy.

And third, sleep specialty utilization for LUMRYZ coming from switch patients currently taking twice nightly oxybates as well as those who are unable to stay on twice nightly therapy. Further, our research suggests LUMRYZ will become the first choice oxybate for previously untreated oxybate eligible patients.

We continue to see the consistency from our market research above the impact that LUMRYZ can have in addressing the unmet need for people with narcolepsy and the significant interest from sleep specialists that can make LUMRYZ the preferred treatment in a growing oxybate narcolepsy market.

Now, I’ll provide an update on our readiness efforts, as we have significantly expanded the scope of our execution against our launch plans. First, we have packaged a significant amount of commercial supply for LUMRYZ in its primary daily packets. For product fulfillment, we have completed the REMS programming and along with our patient services center, both teams have been actively ramping up their hiring and should be fully staffed in the next couple of weeks.

We’ve also signed contracts with our full specialty pharmacy network. On the payer front, our team has several key meetings with decision makers at the GPOs and PBMs that manage over 85% of the commercially insured lives. With the favorable decision in the Federal Court, this REMS patent delisting and our REMS, our LUMRYZ amendment submitted, our conversation with payers have accelerated around contracts and coverage for LUMRYZ and the feedback continues to be positive.

We’ve also been focusing on building an exceptional team to support LUMRYZ. We have hired the majority of non-customer facing roles across the team and have made offers to the majority of our territory business managers or sales representatives and our field reimbursement team for them to start in the next couple of weeks.

For our sales team, we have prioritized hiring people with rare disease experience, previous sleep experience, or experience with our target prescriber base, as well as their ability to deliver in highly competitive markets.

Now, of course, like the rest of our team being aligned to our core values and always putting patients first is a must. The energy and excitement from our current Avadel team and our new colleagues joining us is helpful. And our goal is to ensure everyone on our team is singularly focused on how to improve the lives of people with narcolepsy. We look forward to providing more updates on future calls.

And with that, I will now turn the call over to Tom for an update on the company’s financials. Tom?

Tom McHugh

Thank you, Richard. I’ll note that full financial results are available in the press release and the 10-K and details of our recently completed financing transactions are in the 8-Ks we filed. I’ll start with comments about our recent financing announcements. I am pleased to report that we executed the financing strategy that we’ve been communicating for the past several months and accomplished two critical goals.

One, secured $200 million of funding for the anticipated launch of LUMRYZ in the form of committed capital from a $75 million royalty financing and immediately available capital from $125 million equity offering. Two, we addressed the maturity of the convertible notes, which strengthen our balance sheet, and provides financial flexibility to focus on our launch priorities.

Our financing strategy consists of three major components. First, we complete an exchange of $96.2 million of the convertible notes, and importantly extended the maturity out to April 2027. This eliminates or would’ve potentially been a significant use of cash later this year and moving this debt to a long-term obligation significantly improves our balance sheet and financial flexibility.

Second, we secured committed capital in the form of a $75 million royalty financing from RTW Investments. The funding will be available to Avadel in two tranches of $30 million and $45 million upon meeting certain regulatory and financial milestones, and we expect the first tranche will be available following the launch of LUMRYZ.

The second tranche of $45 million is available to draw at our option upon achieving a revenue milestone should we choose to do so. This component of our strategy provides us with the security of a future funding commitment and with favorable terms such as a royalty rate of 3.75% and lack of financial covenants. We sincerely appreciate the support of RTW and the confidence they placed in Avadel to deliver the value we believe LUMRYZ promises.

Third, we completed an equity raise, which generated gross proceeds of $125 million. This component of our financing strategy provides the immediate capital needed to fund the launch of LUMRYZ. The significant support that our shareholders demonstrated through their participation in the equity offering speaks to the confidence they have in the potential value of LUMRYZ.

As our previously stated, we are pleased with the results of financing strategy the state’s [ph] investors have placed in the company and their confidence in the opportunity that lies ahead for LUMRYZ.

On a final note, we reported $96.5 million of cash, cash equivalents and marketable securities as of December 31, 2022. For additional detail on our 2022 financial results, please refer to the press release issued earlier this morning or the 10-K filed yesterday. The combination of cash on hand, the maturity extension of the convertible notes and the capital we secured allowed us to file a clean 10-K with a strong balance sheet.

The actions we took last year resulted in closing out 2022 with over $95 million of cash, and that in addition to the financing stretch we completed put the company in a strong financial position as we get ready for our anticipated launch of LUMRYZ.

I’ll now turn the call back to Greg for closing remarks.

Greg Divis

Thank you, Tom. From where we sit today, we are operating from a position of strength across our organization. On the cusp of a pivotal moment for the company as we transition to a commercial company poised for significant growth and rapidly approach the opportunity to make a meaningful and positive impact for patients and the narcolepsy community at large. The significant milestones we have recently achieved including submitting our amendment to the LUMRYZ NDA along with executing multiple strategic financings are critical steps toward our mission, built on the foundation of a clear value proposition of LUMRYZ, which has been recognized by our key stakeholders, including patients, sleep specialists and shareholders.

With the work our team has done over the past few months from a legal, regulatory, financial and organizational readiness perspective, we are in an excellent position to take our next step to bring LUMRYZ to the narcolepsy community. We are ready to deliver on the promise of LUMRYZ to transform the market and the lives of people with narcolepsy.

We thank you for your support. We look forward to providing future updates on our progress. And with that, operator, we’ll open up the call for questions.

Question-and-Answer Session

Operator

[Operator Instructions] Our first question comes from the line of Chris Howerton with Jefferies.

Chris Howerton

Great. Thank you so much for taking the questions and just wanted to offer my congratulations on all the financing and the updates. I guess, two questions from me. One would be in terms of kind of the pricing strategy that you’re expecting to use. Maybe you could give us a little more color on kind of how you’re considering pricing of LUMRYZ in this market and maybe is a little corollary there. In those discussions, do the payers have the generic twice nightly oxybate on their radar as part of that discussion? And then a second one would be just kind of, are you anticipating a bolus of launch or a bolus of patients expecting to get on LUMRYZ at launch or should this be more of a gradual thing? Great, thanks.

Greg Divis

Yes. Thanks, Chris. Richard, maybe you can start with the pricing in commentary and then – and certainly I can comment on the how we’re thinking about forecast.

Richard Kim

Yes, sure. Hey, thanks for the question, Chris. So, yes, as far as our pricing is concerned, I mean, our overall strategy based on the value proposition of LUMRYZ has been – we’re going to win with patients, win with providers and in essence, really a draw with payers really more from a parity perspective. So we’ve been very consistent in our messaging that our target price for LUMRYZ is going to be more in the parody range with the branded oxybates.

And as far as the AGs are concerned, yes, we’ve definitely had a chance to speak to all the payers thus far. And I think the general feedback on the AG is it is being treated like a brand expansion. It is from what we see now, it is beginning to get coverage, but we haven’t seen any movement of force movement from a branded twice like oxybate to the AG at this stage. So we’ve built our whole strategy knowing that the AG will be in the marketplace. So the fact that it’s here is really very much in line with our plans and so far our conversations with the payers have been really, really positive as well. So and Greg, I’ll pass the next question to you then.

Greg Divis

Yes. I think, Chris, as it relates to how we think about the early months of launch, we certainly don’t intend to guide with any specificity from that standpoint. We’ll talk more about how we think the market opportunity is and what that looks like as we get through the next number of milestones from an approval and leading into a launch. But I think at the end of the day the team has done a great job to be – to think through all the potential things that happen early on in kind of ordinary course of product launches from reimbursement to transition into patient services center to securing coverage and whatnot. So we’re putting in all the necessary capabilities to be able to address those things and we’re pleased with the progress we made and the feedback we’re getting both across the patient community, physician community, and payer community.

Chris Howerton

Okay. Well, that’s awesome. And again, congratulations, both.

Greg Divis

Thanks, Chris.

Operator

Our next question comes from the line of Adam Evertts with LifeSci Capital.

Adam Evertts

Great. Good morning and congrats on all of the great news this quarter as well as strengthening the balance sheet. So I just wanted to ask, make sure I’m clear on what will be in place at the time of full approval, assuming that occurs in early May. I mean, it sounds like the commercial team, including the sales force will be ready, product will be available roughly four weeks later. And then just remind me, I think Richard maybe said it on the REMS program that will also be in place by approval or certainly by launch.

Greg Divis

Yes. Thanks, Adam. Richard, do you want to comment on that?

Richard Kim

Yes. Hey, Adam. Thanks for the question today. So, yes, we – as far as our operational perspective, as far as REMS distribution, we’re – the REMS is in essence programming is done. We’ll be hired – fully staffed for both our REMS program and our patient services center within the next couple of weeks. So that first phase we’re ready, we could be flipped to switch in just a couple weeks here as well. To your point, as Greg had mentioned, supply should be available approximately four weeks after a final approval and our team is coming on board as well. So we are ready to be able to deliver this. And yes, so all of our key components are ready to go in the next couple of weeks.

Adam Evertts

Fantastic. And then one quick one for Tom. Tom, you mentioned the second tranche on the royalty side that was triggered by a regulatory milestone or a sales milestone.

Tom McHugh

The second tranche of $45 million is on a quarterly revenue milestone.

Adam Evertts

Fantastic, thank you.

Operator

Our next question comes from the line of Francois Brisebois with Oppenheimer.

Unidentified Analyst

Hi, this is [indiscernible] on for Franc. Congrats on all the progress and thanks for taking our questions. Just a quick one from me. In terms of the payer discussions, just wondering how useful or important are these real world outcome studies that you have been doing? And is this coming up in these payer discussions from a payer’s perspective in terms of reimbursement? Thanks.

Greg Divis

Richard, you want to go or…?

Richard Kim

Yes.

Greg Divis

Sure.

Richard Kim

Yes. Hey, Dan, thanks for the questions. So I think the really great thing is with the recent regulatory and legal events have come on, the payer engagement has definitely stepped up to that next level overall here as well. And on – I think holistically, the good news is we’re really focusing on really strengthening the conversations around the clinical value proposition. So the team has been doing clinical presentations and I think going for, I mean, the payers are always interested in the real world evidence. So those questions do come up and I think we plan on sharing more of that as more of the data continues to be published as well. So overall, the conversation has definitely been a lot more shifted towards the clinical value proposition of LUMRYZ.

Unidentified Analyst

Great, thanks for that. And just a quick one, I believe you already talked about it, just to be clear, in terms of the REMS build out. So at this point is the – on the technology infrastructure standpoint, is that already completed and now staffing is the next thing.

Greg Divis

In short, Dan, that exactly correct. And staffing is ongoing now. So as Richard noted, within a matter of just a couple weeks that will be fully operational. And Jen, I know this goes under your purview, so if you have any comments you want to add, please do.

Jennifer Gudeman

You described it perfectly. So programming is complete. The staffing is taking place right now, and we’re just a few short weeks away from being ready to go.

Unidentified Analyst

Awesome. Thanks for all the updates and congrats again on the year. Thanks.

Greg Divis

Thanks, Dan.

Operator

Our next question comes from David Amsellem with Piper Sandler.

David Amsellem

Thanks. So just had a couple you talked through the challenges with middle of the night dosing. But I wanted to get your thoughts on potential counter detailing messages from your competitor, things that we’ve heard anecdotally from KOLs, like taking LUMRYZ too late at night, potential interfering morning functionality or even bedwetting. So how do you respond to that kind – those kinds of concerns and particularly as it relates to competition and messaging, what is your counter to those kinds of concerns? So I’ll stop there.

Greg Divis

Yes, thanks, David. Well, Jen, I’ll let you go first.

Jennifer Gudeman

Sure. That’s great. We have conducted two relative bioavailability studies comparing LUMRYZ to twice-nightly oxybate. And what we have shown is that our concentration eight hours after taking the dose is actually a little bit lower than twice-nightly oxybate. So based upon those blood levels there would not be any sort of expectation of impairment the next day, and that certainly is not something we’ve seen in our pivotal clinical trial or in our open label study. I think it’s also really, really important to note that with any oxybate you shouldn’t drive or operate heavy machinery six hours after taking the dose. When you think about LUMRYZ that covers the nocturnal sleep period. When you think about twice-nightly and that 90-minute window when you can take your second dose, when patients are waking up later that is a restriction with that additional six hours that oftentimes does interfere with next day functioning.

Greg Divis

Thanks Jen. Richard, anything you want to comment?

Richard Kim

Yes. Hey David, I just would sort of add, you know, it’s quite interesting – oh, we hear bit of background noise, David.

There we go. Hey thanks. So David, your question as far as some of the counter messaging is concerned, so I think for us the one thing we have realized over the last 20 years is I don’t think anyone has really thought making patients wake up during the middle of night has been normal. And where we see that most predominantly in our market research around de novo patients, we’re absolutely consistently physicians will state that they would want to start patients on LUMRYZ.

Why would they offer a therapy where you have to get up during the middle of the night? And to Jen’s point, we also know that the – and if there’s any tolerability issues with oxybate, they generally tend to subside over time as well. But I think for us where we sort of see it is physicians are speaking sort of with their, both as far as the need to not or the ability to not offer that second dose is an intuitive proposition for new patients that we believe will aptly spillover into existing patients as well. So we – if that – if those are the counter messages that come up, we’re more than prepared to deal with them and we believe our campaigns will address them head on.

David Amsellem

That’s helpful. If I may just sneak in a follow-up; do you think you’re going to be able to pull in patients who have gone to low sodium already?

Greg Divis

Yes. So David, when we do our patient research, what we find about patients who have gone to the mixed-salt version of the twice-nightly oxybate, they tend to be patients who have been diagnosed with narcolepsy for a shorter period of time, and they tend to be earlier adopters of therapy. They’re generally not satisfied as treatment and seeking more. So even though they have switched to the mixed-salt version they are – all of our patient segments show an extremely high level of interest in learning about LUMRYZ or potentially switching. Ironically, the highest group just nudging out the Xyrem patient are those on the mixed-salt, and our belief there is because they are the ones who are going to most often seek more that they can do to manage their narcolepsy.

David Amsellem

Thank you.

Greg Divis

Thanks David.

Operator

Our next question comes from the line of Marc Goodman with SVB Securities.

Unidentified Analyst

Hi, thanks for taking my question. It’s Rudy on the line for Marc. Congrats on the progress. We can talk about your operating expenses in 2023 based on your current commercial launch funding. Now, we’ll raise another, around maybe $200 million, do you need additional funding before breakeven? Thanks.

Greg Divis

Yes. Thanks for the question. We’re really pleased, we made a capital rise. We’re not providing guidance on operating expenses. We’re heading into 2023, but from our standpoint with the capital that we now have we’re quite frankly good to go for a launch.

Unidentified Analyst

So that’s very helpful. And also can you talk about the IP, you mentioned that you have 13 patents now currently in these products, like what give you the confidence about the strengths of the IP position?

Greg Divis

Well, I think first and foremost we’re quite proud of the fact that we’re the first and only company to actually have innovated a once at bedtime or once nightly oxybate treatment option. And you would assume that we have and will continue to protect it to its fullest extent. The patent families that have been granted so far with many more to come, I would say we’re quite confident in. They’re generally directed to once nightly oxybate formulations which includes obviously our formulation but other types of formulations, pro drugs, polymers, alternate salts and whatnot as well as methods of treating patients in a manner that we believe is consistent with what our final label will be. So we’re quite confident in the robustness of our intellectual property, the 13 Orange Book listed patents we have so far, and the more to come.

Unidentified Analyst

Got it. That’s very helpful. Congrats again on a quarter.

Greg Divis

Thanks Rudy.

Operator

[Operator Instructions] Our next question comes from Matt Kaplan with Ladenburg Thalmann.

Matt Kaplan

Hello. Good morning.

Greg Divis

Hi Matt.

Matt Kaplan

Hi. Just a couple of questions; in terms of maybe one to Richard, can you get – provide some more color on the sales organization in terms of number of sales reps and number of regions and kind of your go-to-market strategy with the sales team?

Richard Kim

Yes. Sure Matt. No problem. So our sizing for the sales force is based-off of the insight that there are less than 5,000 prescribers of oxybate in the last three years. Of that 1,600 makeup 80% of the volume in less than 500 make up, 50% of the total prescription volume. So we we’re sizing it around 50 to really sort of focus on those groups. But right out of the gate, we’re probably going to spend a little bit more time on the 1,600 that make up 80% of the prescription volume.

Now for the – we will cover the entire group and also including a few high narcolepsy prescribers who don’t use oxybate. And also interesting for us, if we do get some other sort of people interested earlier on, our REMS is almost like an early detection signal, which will allow us to get out to those offices and really ensure that they’re set up well before that first prescription goes forward. So we’re starting to focus where the oxybate experience is, and then from there we can expand over time.

Matt Kaplan

And then in terms of your patient support services center how will that function to help patient get reimbursement and get coverage?

Richard Kim

Yes. It’s one of the things that I would sort of see its going to be our secret sauce this launch. We know prescribing and fulfilling any specialty product in the United States is a challenge. It’s just not made easy for folks. So it’s beyond our patient. Our patient services center will be actually staffed with nurses, nurse care navigators, so they will understand more both the clinical and the reimbursement aspects. They’re actually going to be accredited in actually reimbursement services as well. So our goal there is each office will actually have a dedicated person that they can build a longer term relationship. It won’t be sort of mix-and-match in different nurse care navigators.

But the other thing that we are also building out concurrently and have already made offers for field reimbursement team. And those are folks who will be able to go directly into the offices as the specialists and really help support the staff that focuses on reimbursement, both in a live aspect there and then that the patient support center will help both office and also guide the actual individual patients themselves as well. So we’ve really invested a lot of time and energy because first we believe that the LUMRYZ value proposition will generate a lot of excitement with prescribers and patients, but we’ve got to make sure that we’ve had, and we’ve spent the time to build the resources to make sure that we can get the fulfillment taken care of as well.

Matt Kaplan

Okay. That’s very helpful, thanks Richard. And then a question for Tom in terms of the royalty interest financing with RTW term there; can you help us understand in terms of the amount you’ll have to pay back to RTW if you pull down the full amount? Or if you don’t – if you only pull down the first tranche, it’s, yes, is it 2.5 times the funding or how does that work?

Tom McHugh

No. Thanks Matt. Listen, I think one of the great things about the royalty financing is the flexibility we have on the second tranche where it’s really at our option to draw it or not. So if you’re focus on the first tranche it’s in our 8-K filing, there’s a lot of details out there, but the hard cap is 2.5x.

Matt Kaplan

Okay. That’s helpful. Thanks Tom.

Tom McHugh

Thanks Matt.

Operator

That concludes today’s question-and-answer session. I’d like to turn the call back to Greg Divis for closing remarks.

Greg Divis

Thank you. And thank you everyone. Thank you for your time in joining us today on our fourth quarter and full year 2022 earnings call. We appreciate your spending the morning with us and wish you a great rest of your day. Thanks.

Operator

This concludes today’s conference call. Thank you for participating. You may now disconnect.