Good morning, ladies and gentlemen. Thank you for standing by and welcome to the Avadel Pharmaceuticals Second Quarter 2019 Financial Results Conference Call. At this time, all participants are in a listen-only mode. I will now turn the call over to Mr. Mike Kanan, Chief Financial Officer of Avadel. You may begin..

that products in the development stage may not achieve scientific objectives or milestones or meet stringent regulatory requirements; uncertainties regarding market acceptance on products; and the impact of competitive product and pricing.

These and other risks are described more fully in Avadel's public filings under the Exchange Act, including the Form 10-K for the year ended December 31, 2018, which was filed on March 15, 2019.

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 with me today are Greg Divis, our Chief Executive Officer; and Dr. Jordan Dubow, our Chief Medical Officer.

At this time, I will turn the call over to Greg Divis.

Greg?.

number one, the rapid and substantial organizational restructuring and cost reduction actions; number two, the operational focus on FT218, ensuring we put in place the people and the plans required to deliver a timely, a complete and a provable and commercially viable NDA in FT218; and number three, the continued optimization of the positive cash flow being generated by our legacy hospital business.

Specifically, in quarter two, we saw better-than-expected revenue from our hospital portfolio, while our restructuring and cost reduction actions taken to-date helped us on track to realize between $80 million and $90 million in annualized cost savings.

This combination of aggressive cost reductions and the better-than-expected revenue performance during the first half of 2019, have accelerated our progress in stabilizing the company's financial and operational health. In the second quarter, this was demonstrated by only a nominal use of cash, while we have continued our investment in FT218.

Through the balance of 2019 and beyond, we believe that Avadel is well positioned to continue advancing FT218, as we work to bring this much-needed therapeutic alternative to narcolepsy patients. Let's review some of the highlights for the second quarter. Regarding FT218, enrollment in the REST-ON study continues to progress in line with our plans.

As of today, we have randomized 183 subjects, or nearly 70% of our target enrollment. Based on the current enrollment rate, we remain on track to complete enrollment in the second half of 2020. In support of our efforts to advance FT218, we have significantly strengthen our clinical and medical team, with the appointment of Dr.

Jordan Dubow, as Chief Medical Officer, as well as the recently announced appointment of Courtney Wells, as Vice President Clinical Operations; and Dr. Dave Seiden, as Senior Medical Director, Clinical Development and Medical Affairs. Jordan will discuss these key appointments and provide an update on the FT218 program in a few moments.

Our new clinical and medical team is already beginning to make an impact on the FT218 program. We are confident in and look forward to the team's impact and their contributions to bringing FT218 to market in both a comprehensive and expeditious manner.

The potential importance and contribution to patient care of FT218 continues to manifest itself in many ways. Patients, doctors as well as payers, all have expressed a high degree of interest in the potential value of a once-nightly sodium oxybate treatment.

This was also demonstrated in a pharmacokinetic, or PK, work we have conducted to differentiate FT218 in the narcolepsy space, some of which was recently highlighted in the data presented at the SLEEP 2019 conference.

We presented data from a head-to-head PK comparison study of our once nightly 4.5 gram FT218 to twice nightly 2.25 grams of immediate-release sodium oxybate. In addition, we presented data from a dose proportionality study, which demonstrated linearity across three increasing doses of FT218.

This data demonstrated once nightly FT218's lower overall peak plasma concentrations and similar total drug exposure as measured by area under the curve or AUC when compared to twice-nightly sodium oxybate.

Before turning the call over to Jordan for further update on FT218, I'd like to share some highlights on our current operational and financial position. First, the major restructuring we initiated in quarter one has yielded the results we sought to achieve. Our SG&A expenses are down substantially year-over-year.

And as already noted, we continue to expect to realize $80 million to $90 million in annualized cost savings. Secondly, we remain focused on maximizing the opportunity and cash flow from our hospital products business. For existing legacy hospital products, the business had another strong quarter.

Based on performance to the first half of the year, which is well ahead of previous guidance, we now expect full year 2019 revenue to be in excess of $45 million.

It is important to note that given the nature of this business and the previously approved and assumed new competitors we maintain our expectation for increasing downward pressure on pricing and revenues going forward.

As we have done in the past, we will continue to aggressively defend our position in each of their respective markets, while we carefully manage both margin and expenses to ensure that the business continues to generate positive cash flow and support the development of FT218.

Furthermore, as we shared yesterday the NDA for AV001, which was submitted on March 15 and accepted by the FDA with an original assigned PDUFA date of September 15 had its PDUFA action date extended to December 15. This extension was related to information and data the FDA had requested from the company during the ongoing review of the NDA.

We submitted the requested information by the FDA's deadline and it is in their discretion to extend the PDUFA date when new or additional data are provided.

It is important to point out that this three-month extension in no way changes our planned commercial launch timing or our belief in the strength of the NDA package we've submitted, including the additional data we have provided. It is our expectation that if approved AV001 will begin to contribute to revenues in the first quarter of 2020.

I am pleased to report that to-date, Avadel is a very different company than what it was entering 2019.

We have undergone a series of significant changes that had contributed to our improved organizational focus and our financial health, all of which continues to position us to drive the further development of FT218, which we believe has disruptive potential in a $1 billion plus market. With that, I'd like to turn the call over to Dr.

Jordan Dubow, our Chief Medical Officer to provide further commentary on the FT218 program.

Jordan?.

number one, assemble a clinical and medical team to optimize the development of FT218 and help differentiate it in the market; number two, complete the third-party review of the REST-ON clinical trial and the FT218 development program; number three, more closely engage with the sites enrolling patients in the REST-ON trial; and number four, further strengthen the body of clinical evidence supporting FT218 as a potential alternative to the current standard of care for narcolepsy patients.

Speaking with all of you today, I'm pleased to report the important progress towards each of these objectives. As we announced last week, we strengthened our clinical and medical team with the appointments of Courtney Wells, as Vice President Clinical Operations; and Dr. David Seiden as Senior Medical Director.

In Courtney and Dave, we have two seasoned highly accomplished clinical development and medical peers professionals with contributions will give us the depth needed to complete the REST-ON study, prepare a comprehensive clinical data package to gain regulatory approval for FT218 and help us position the product with differentiated data to drive its anticipated commercial success.

Since I joined the company, the third-party review of the REST-ON clinical trial and the broader FT218 development program has been completed.

While we are confident in the overall status of the program as originally developed, we have identified and are evaluating certain potential opportunities to enhance both the REST-ON clinical trial and FT218 eventual position in the market.

We are expeditiously evaluating all potential opportunities and we look forward to sharing more details in the coming months. In the meantime, enrollment remains on track and we continue to expect completion in the second half of 2020. Since joining Avadel, we've had the opportunity to meet with all of the actively enrollment sites.

The aim of this increased engagement is to maximize enrollment efficiency output and to ensure that we are providing the resources our investigators need to most effectively serve patients.

The last of my immediate objectives is to further strengthen the body of clinical evidence supporting FT218 as a potential alternative to the current standard-of-care. We've made great progress on this front as well.

In June, at the SLEEP 2019 Conference, we presented two posters on FT218 including a head-to-head pharmacokinetic comparison between our investigational once-nightly formulation of sodium oxybate and the standard-of-care a twice-nightly formulation.

In the head-to-head PK study at the 4.5 gram dose level, FT218 exhibited rapid initial absorption, comparable to twice-nightly immediate-release sodium oxybate, a lower overall Cmax in twice-nightly sodium oxybate.

Similar overall exposure in mean blood concentrations at eight hours that were similar to twice-nightly sodium oxybate with safety and tolerability similar across administrations.

The results of the dose proportionality study we presented demonstrated that FT218 at each of the three doses administered exhibited PK profile consistent with those needed for a once-nightly dosing regimen.

Dose proportionality was maintained for Cmax across the dosage range and the safety profile was consistent with what is known for sodium oxybate. The response of these data from those who attended the conference was extremely encouraging and supports our enthusiasm towards FT218.

We are building upon this excitement as data from another study has recently been accepted for an oral presentation at the World Sleep Congress in Vancouver in September. We look forward to sharing that data with you in the coming weeks as well.

In summary, we are highly encouraged by the progress our new team has been making with FT218 and the REST-ON study. We believe that we have built the right team to make the type of impact that is required to bring FT218 to the market in the most expeditious and complete manner.

With that I would like to turn the call over to our CFO Mike Kanan to review the financials.

Mike?.

Thanks Jordan. Before detailing the financials for the quarter, I want to summarize some important financial highlights. First, as you heard Greg say, revenues from our hospital business were better than we anticipated when we began the year and when we updated our full year revenue guidance back in May.

Revenues were $17.6 million in the second quarter and this is $1.1 million higher than the first quarter of 2019. We are pleased with this quarter's performance as our legacy hospital business continues to generate positive cash flow. Second, our cost reduction actions are taking hold.

We have cut cost by about $40 million through the first six months of 2019. And as you heard Greg say, we are on track to meet the $80 million to $90 million cost reduction goal we targeted earlier this year. These actions including cost reductions in France, Ireland, and the U.S.

were needed to align the company's cost structure with the realities of our business. It's worth noting that virtually all cost associated with Noctiva and Avadel Specialty Pharmaceutical LLC have been eliminated. Our restructuring actions in Ireland are complete and well underway in France.

I'm pleased to say that the cost to implement these restructuring actions are trending lower than we originally we projected. As you may recall we expect $10 million to $15 million of restructuring costs.

Through June 30th, we've incurred about $3 million of restructuring cost and now expect cash restructuring cost could be between $5 million to $7 million in total. And finally, I'm pleased to say that our use of cash or our quarterly cash burn was minimal in Q2. Cash at the end of June was $79.3 million compared to $79.9 million at the end of March.

Better than forecasted revenue as mentioned, improvements in working capital, and our aggressive cost reductions have been key components of mitigating our cash use.

Based on these cash flow trends and factoring in our current plan, including anticipated cost reductions resulting from our restructuring actions and our longer-term cash flow projection for our hospital portfolio and the continued investment in FT218, cash on hand is expected to be sufficient to fund operations into 2021 and this includes completion of the REST-ON study and disclosure of topline results.

Now, I would like to touch on the rest of the financial highlights for the quarter. As mentioned, revenues were $17.6 million for the second quarter, down from $29.2 million in the second quarter last year, due to lower net selling prices across all of our hospital products, as a result of increased market competition and price compression.

As previously stated, Q2, 2019 revenues were higher than we anticipated due primarily to competitive launches and/or pricing actions that did not occur during the quarter. We still do expect increased competition from products launched or expected to be launched in 2019.

That said however, due to the strength seen to date, we now project annual revenues to be in excess of $45 million for 2019. This represents an increase from our prior guidance which call for total revenues to be above $30 million. R&D expense was $10.3 million in the second quarter of 2019, compared to $11.9 million in the second quarter last year.

This decline was primarily the result of lower spending associated with the exit of NOCTIVA and the cost reduction actions we've taken at our Lyons France R&D center. We continue to invest however a substantial amount of our R&D expenses towards the clinical development of FT218.

SG&A was $6.8 million in the second quarter, compared to $27.8 million in the second quarter of 2018. This significant reduction was primarily due to cost reduction associated with the exit from NOCTIVA which was about $18 million and lower G&A expenses resulting from cost reduction actions we implemented as part of our commitment to preserve cash.

Restructuring charges were $1.5 million in the second quarter of 2019, mostly related to the restructuring actions in France that we initiated early in 2019. And finally, as some of you may be aware, the IRS made a $51 million claim as part of the bankruptcy claims process against Avadel Specialty Pharmaceuticals LLC. Specialty Pharma files its U.S.

Federal tax return as a member of the company's consolidated U.S. tax group. The IRS claim was filed against Specialty Pharma in the bankruptcy proceedings as Specialty Pharma has joined in several liability for all members of the consolidated U.S. tax group. We are working closely with a big four tax adviser and our legal advisers on this matter.

Both Specialty Pharma and the company disagree with the merits of the IRS claim and we intend to defend our positions vigorously. We are pleased with our overall financial performance over the last quarter and through the first half of the year.

The benefits of our cost reduction initiatives we've undertaken are beginning to be reflected in our results and we are positioned well moving forward. Now, I'd like to turn the call back over to Greg..

Thanks, Mike. Avadel continues to make substantive progress in reshaping itself to focus on our investigational product FT218 and to ensure, we have the necessary financial flexibility to optimally position this novel once-nightly therapy to address the major unmet medical needs in the narcolepsy community.

Thus far in 2019, we have undertaken a number of actions aimed at maximizing the potential for success of FT218. Over the last several months, we have preserved cash by advancing the restructuring and cost savings plan announced in early February. We've strengthened our clinical medical team with key appointments.

We've completed the rapid exit of NOCTIVA via the bankruptcy sale of the assets of Avadel Specialty Pharmaceuticals LLC to stem that subsidiary's untenable cash burn. We've created a new level of transparency with our investors, including on REST-ON enrollment which has continued to progress according to plan.

We've presented data further highlighting the potential compelling value proposition of FT218 at the SLEEP 2019 conference. We've obtained intellectual property protecting FT218, through mid-2037.

And our AV001 NDA was accepted for priority review with the third quarter 2019 PDUFA date, which has subsequently been extended to the fourth quarter, as previously described.

As a result of these milestones, we are confident in the progress we're making organizationally and specifically with FT218, a Phase 3 asset targeting a market that exceeds $1.5 billion.

Our registration study is proceeding according to plan, and we are well on track to complete enrollment next year, while simultaneously our strength in clinical and medical team are pursuing potential opportunities to enhance our FT218 program, including the REST-ON trial.

Although, we are not disclosing any of these possible enhancements at this stage, given the competitive dynamics of this therapeutic area, we will most certainly update our investors as appropriate on the progress of all material aspects of the FT218 program, both quarterly and as necessary to ensure we keep our shareholders duly informed of these important developments as we continue to work toward our objective of bringing this novel once-nightly therapy to patients.

We're proud of the progress we have made to-date and look forward to the opportunities that lie ahead. With that, I believe operator, we're ready to open the line for some Q&A..

[Operator Instructions] Our first question is from the line of Matt Kaplan from Ladenburg Thalmann. Your line is open. I'm sorry. Our first question is from the line of François Brisebois from Laidlaw..

All right. Thank you. Congrats on the progress. Thanks for taking the questions here. So a couple, so I'm just looking at – so now it seems like it's – sorry, the percentage is now 69% enrolled from 63% on the last quarter.

Are there reasons to expect lumpiness in terms of enrollment due to maybe seasonality or whatnot? Or is it fair to see – I guess with the ramp that you've been doing it seems like late in the second half 2020 it'd be fine right now.

But are there any reasons to expect certain lumpiness throughout this enrollment process?.

Jordan?.

Yeah. Thanks for the question. I think in all clinical trials, there's ups and downs, with enrollment. Some of it is seasonality based and how they are given, we're in an international trial. However, we believe that enrollment is going to continue with plan and it's been continuing this way the last two quarters.

And now when we expect that continue – to continue through next year..

Okay. Great.

And then in terms of -- you've talked about the – at the SLEEP conference the PK results the difference there is that lower Cmax? Can you discuss potentially the importance of this? Or are you just trying to be pretty much equivalent to the two times nightly and just have it onetime instead of twice?.

So our data that we presented at the 4.5 gram dose level showed that our total exposure was comparable and basically identical to that of the reference product twice-nightly sodium oxybate. The Cmax that we have our overall Cmax was lower than their Cmax at the highest dose. In terms of what that means can't really comment on that.

I think we're just – we're comfortable with our PK and it gave us the confidence we needed to move into the Phase 3 trial..

Understood. Okay. And then just in respect on the FT218.

From the complete potential enrollment in the second half 2020 can you just remind us of the steps following that in terms of seeing data from it?.

Yeah. So, Frank, this is Greg. I think as we think about completing last patients into the trial last patient, first visit, it's approximately 13 weeks of treatment that follows that and then you would have what would be last patient last visit we would data log.

And then our expectation is that, we would have top line results likely within 90 days of that last patient last visit in the data log..

But then, do you have to kind of look at that top line result and digest it? Or is this something that could be quickly showed to the Street?.

Yes. I think that 90 days would be the approximate time frame of when that data as we think about it today would be disclosed..

Okay, great. And then on the -- I guess on the top line, the hospital products it's quite a beat that you guys had versus the trend that's been going on with that platform.

Anything specific on any product in specific or a competitor that did not come in necessarily? Or anything to explain this jump?.

Yes, I think Frank, the really, the primary drivers of what we would characterize as the favorability of the business the strength of the business to date has really been, really tied to the timing of competitive launches.

Earlier this year, when we came out with our initial guidance, there has been a number of recently approved competitors that we had assumed would have come to market by this time. And quite frankly they haven't. So that's been a positive for us. And the performance of the business, we can't speak to when they will come or if they will come.

Our assumptions are that they will come and -- but that's been the primary driver..

Okay. Great. No that's all very helpful. And then just lastly Mike the last comment you had in terms of the IRS.

Can you just talk about maybe the cost related to this? Is this something that is a big hit potentially? Or is this kind of de minimis for the -- if you look at the numbers that you guys have?.

Frank, it's Mike. No, this IRS claim was a complete surprise to us. It's really without merit. We're defending ourselves vigorously around this. We do have an audit that's open for 2015 and they're starting to audit 2016 and 2017. And none of the issues that have been raised so far in the audit have even come close to what this claim is.

Administratively, we're going to defend ourselves. We will incur some cost for lawyers and accountants and tax advisers to help us through this, but it won't be significant in nature. So we are not -- you've got to take these things seriously from the IRS.

But honestly, it's without merit and we're going to defend ourselves vigorously through this process. When we prepare our audited financial statements each year as you may know, we look at all of our tax positions and we record any tax provisions or tax liabilities we may have for any exposures.

And we've done all that as part of the preparation of our 10-K and 10-Q. And we're not going to take any further charges around this matter at this point..

Okay. Great.

And just -- can you just remind me when this kind of came about and I guess when you would expect the resolution?.

Well it came about in very late June, but we didn't become aware of it through the bankruptcy process until early July. That's when we became aware of it. And I can't predict how fast or how long this will take to get resolution to, but we all have a sense of urgency for it, because we want to exit bankruptcy and complete the plan of bankruptcy.

And this is part of that process to get through bankruptcy. But we've got a sense of urgency around it to get this completed..

Okay. All right. Well thank you. That's it for me and congrats on the progress..

Thanks, Frank..

Our next question is from the line of Matt Kaplan from Ladenburg Thalmann. Your line is open..

Hi. This is Yinglu again for Matt. I think I have a couple of questions.

First for FT218 given the recent progress you made enrolling patients into the REST-ON study, are you considering adding more study size to continue the acceleration of enrollment? And also based on the PK profile you presented at the SLEEP conference, are there any potential safety or efficacy advantages for FT218 versus Xyrem which we could be seeing in the REST-ON study?.

Yes. So thanks for the questions. So in terms of size we're focused on our actively enrolling sites right now resources, efforts. Everything is focused on those sites that are being active.

In terms of adding additional sites, we're constantly evaluating ways to improve enrollment on the study, but I'm not going to comment specifically on sites that we may or may not add. In terms of the pharmacokinetic profile, as I said, we were -- the data that we presented at SLEEP gave us the confidence to move forward in Phase 3.

We're, obviously, excited and feel good about our exposure is the same, it's twice-nightly sodium oxybate that our Cmax is lower. We feel very confident that our PK profile is what's needed to give us a once-nightly formulation to provide clinical benefit in these patients.

In terms of specifics efficacy or safety versus twice-nightly sodium oxybate I can't comment on that..

All right. Thank you. And also for the AV001, can you provide us some details around the nature of the data that FDA requested? And also what are you seeing as the market potential for this product? And are there any potential advantages from a safety perspective, which could differentiate this product from the current product on the market? Thanks..

Yeah. Thank you for the question. With regards to AV001, I would -- we would describe the additional data that was requested was much more analytical data that they requested. Remember I would say for reference purposes as a company, we've done three of these NDAs prior.

We have extensive experience and a track record of understanding how to move these unapproved to approved. And the team executed that plan based on a lot of experience and success. What the FDA requested was some additional we wound -- I would characterize it as analytical data.

There's -- we don't do any clinical studies with these products, so it's much more analytical data as it relates to our product and that's the data we provide. That's really all I can share about it.

With regards to the market potential and the safety benefit if you will, what we've said historically has been we have value in the market at around $30 million as a market potential and that's as we see it today.

It was larger in the past but there's been some experiences of product shortages in this category in its history, which we believe has the potential to see the market get stronger again.

And part of our uncovering during this development process was some potential safety issues that were identified with the unapproved product on the market and that is what we have corrected for in our program and our product, and that's what our application now represents with the product that we have developed and have submitted for approval..

Thank you. That was really helpful. My last question is on the hospital product franchise, which was asked about before but I was wondering if you can provide some additional details on the competitive landscape you're seeing for these three products? Thank you..

Yeah, I would say that since the beginning of this year we're early on. We saw a number of new approvals come across in particular in our phenylephrine, our vascular product. That's been -- that was probably the largest category that had the most change in it as we enter 2019.

And it's some of those products that we have been forecasting or projecting potential launches that continued to be delayed for whatever reason. In terms of neostigmine category, it's a fairly stable marketplace at this point. There is a number of competitors. There's I believe nine or 10 in the marketplace now and we remain the market leader there.

In terms of Vazculep phenylephrine there's five in the marketplace and we remain the market leader there. And with regards to ephedrine or Akovaz, there's four. We haven't seen a new approval in that category now for coming up upon nearly two years and that's been fairly stable during the balance of 2019 in terms of both volume and pricing..

Great. Thank you so much and congrats on the quarter..

Thank you..

Thank you..

Our next question is from the line of Michael Sesser from DWS. Your line is open..

Hi, guys. Just one more quick question with respect to the bankruptcy of Specialty Pharmaceuticals.

Is Serenity pursuing any legal action against the company? And do you have any legal liability from that respect?.

Frank with regards to the claim that had -- I mean sorry, sorry Mike with regards to the suit of claims that have been filed within the bankruptcy proceedings there's no -- I would describe as within -- any active litigation between us or Serenity.

They have -- they are an entity within the bankruptcy proceeding that has filed a -- as a creditor in the bankruptcy proceeding. They have filed a claim as a creditor -- as an unsecured creditor and the within the bankruptcy proceeding, but that is the only claim at this point..

So do we know like what -- can you elaborate on their claim as a creditor? And what liability there could ultimately be to Avadel from that claim?.

Yes. Well I'll speak to that kind of overall. We had -- we have a number of unsecured creditors within that pool and the pool of dollars that are available to be distributed upon planned confirmation pro rata assuming those claims are accepted and not disputed is the $250,000 of proceeds that we've received.

So we have $250,000 of proceeds as a result of the sale of Noctiva of the NDA and marketing materials and inventory of Noctiva to the party that acquired it. Those proceeds are what are set aside within the bankruptcy proceeding to be distributed across the claims as the plan gets confirmed..

So there's no way that this could come back to the $70-odd million of cash that's on Avadel's balance sheet..

Yes. We believe that Noctiva and Avadel Specialty is its own entity. Our contractual agreements with -- and contracts with the vendors and partners and those stakeholders within the bankruptcy proceeding are only with that entity and therefore are being adjudicated through this bankruptcy proceeding..

Okay. Thank you..

Thanks, Mike..

At this time, I would now like to turn the conference back to Mr. Greg Divis, CEO. Please go ahead, sir..

Thank you. And as we wrap-up we just want to say thank you for joining us this morning and we appreciate your interest and look forward to following up with all of you. Take care and have a great weekend..

Ladies and gentlemen, this concludes today's conference. Thank you for your participation and have a wonderful day. You may all disconnect..