Good morning and welcome to the Assertio Holdings, Inc. Third Quarter 2022 Financial Results Conference Call. [Operator Instructions] Note this event is being recorded. I would now like to turn the conference over to Matt Kreps from Dara Associates, Investor Relations to Assertio. Please go ahead..

Thank you, Terry. Good afternoon and thank you, everyone, for joining us today to discuss Assertio's third quarter 2022 financials. The news release covering our earnings for this period is now available on the Investor page of our website at investor.assertiotx.com.

I would encourage you to review the release and the accompanying presentation as it is important to today's discussion. With me today are Dan Peisert, President and CEO; and Paul Schwichtenberg, Senior Vice President and CFO. Dan will open the remarks and provide an overview of the business, followed by Paul, who will review our financials.

After that, we will open the call for your questions. During this call, management will make projections and other forward-looking statements regarding our future performance.

Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, including those noted in this afternoon's press release, as well as Assertio's filings with the SEC. These and other risks are more fully described in the Risk Factors section and other sections of our annual report on Form 10-K.

Our actual results may differ materially from those projected in the forward-looking statements and Assertio specifically disclaims any intent or obligation to update these forward-looking statements, except as required by law. And with that, I'll now turn the call over to Dan..

Thank you, Matt. Welcome to everyone joining us this afternoon. The third quarter and the weeks that immediately followed were 1 of the most important strategic quarterly periods for Assertio.

We've pivoted from a period of restructuring in which we improved upon the profitability of our business to the creation of a new commercial platform and now towards growth.

Not only did our financial results in the quarter once again exceed our forecast in nearly every metric, we were able to extend our debt maturity and cut our cost of debt capital from 13% to 6.5%, incredibly low in today's market, exit an unprofitable segment of our business, increasing our future revenue and profit and added a new source of accretive revenue in Sympazan that adds to the diversification of our top line.

As a result of these actions, today we are better positioned to execute other possible business development transactions and our stock is more attractive to existing and potentially new public and private investors. When we began 2022, we had 5 key priorities. I'm proud to say that with our actions in the third quarter, we have nearly achieved all 5.

In a tumultuous job environment, we set our first priority of retaining our employees and attracting new talent. We've had 100% retention in our employee base and have added 8 new employees or over 42% growth. Our second priority was to prove the efficacy of our new commercial model.

We were able to successfully transition Otrexup into the nonpersonal digital model without negative impact. Supply constraints and competitive pressures have shifted the growth targets we had for the brand in 2022 into 2023. Our third priority was to reduce the concentration in INDOCIN.

The acquisition of Sympazan last month provides a good start on this priority but we're not done by any means. We have far more to go. Fourth was the execution of a life cycle management opportunity for INDOCIN. We'll be requesting a pre-IND meeting with the FDA within a matter of days and should have feedback from them shortly after Thanksgiving.

That will put us in a position to file an IND and begin a new clinical program for INDOCIN aimed at expanding the label which is all expected to begin in early 2023. Our final priority was to improve our balance sheet and reduce our cost of capital.

This goal became far more difficult than we imagined now that rates are nearly 400 basis points higher than they were this time last year.

However, we executed on a refinancing transaction this quarter that pushes our debt maturity back to September of 2027, cuts our cash interest cost in half and frees up a substantial amount of cash flow for business development. We think the M&A environment is very robust and buyer friendly right now which the Sympazan transaction exemplifies.

We're able to acquire that asset for $15 million, including the milestone for the new patent. In the trailing 12 months ended September 30, Aquestive recorded $9.9 million in net sales. We've acquired an asset that is growing.

We'll soon have patent protection to 2039 and has gross profit margins very close to our corporate average for 1.5x trailing revenues. The refinancing was especially timely in this environment as this M&A environment continues to ripen and we now have the cash resources and balance sheet to add more products to the portfolio.

In addition, we've built the internal resources and hired external resources to help us identify diligence and contract for more than 1 transaction at a time. Last quarter, we had discussed enhanced commercial strategies for INDOCIN that would be implemented in our third quarter without much specifics as to what these strategies were.

Assertio has taken action to withdraw from the Medicaid drug rebate program which includes 340B. Participation in these government programs is voluntary. As a result of the significant growth we saw in the utilization of our products inside the 340B program, we were incurring significant losses that summed to $6 million annually.

By exiting, we expect to see an immediate increase of $6 million in our annual net revenue and profit. Our actions to remove our products from this program were made public in July.

Since we wanted to avoid end customers that had seen the public notice by significant quantities of product under 340B ahead of our exit, we deliberately reduced channel inventories for INDOCIN in September to under 5 days from what is normally in the low 20s.

This had a negative impact on our volumes and revenues in the quarter which we expect to reverse in our fourth quarter. Offsetting this was a onetime reversal of an over accrual for expected product returns which Paul described in further detail.

Our estimates for a $6 million benefit assume that these unprofitable sales cease because this price is no longer available. However, while it's still far too early to conclude, the opportunity does exist for there to be upside to this. If customers find our products medically necessary and continue to acquire them.

We are offering programs for customers to purchase directly from Assertio at a discount to the published list or WAC price as well. We're quite excited about the potential for Sympazan. It fits all of the criteria that we were looking for in our business development search. First, long-lived IP.

Shortly after completing the acquisition, the Quest have received the notice of allowance for a patent which triggered the $6 million milestone payment that will be made later this month. We expect this patent to be issued and included in the Orange book during the first quarter of '23 and will extend IP protection to 2039.

Second, it's on the market and accretive. Sympazan had been generating annual sales of about $9.5 million. On that basis, we expect it to add between $4 million to $4.5 million in annual adjusted EBITDA and $0.05 in adjusted EPS accounting for the full dilution from the convert. Third, it generates opportunities for growth.

The Quest have reported $2.3 million in net sales for the third quarter which represented year-over-year growth of 15%. From what we saw in diligence, there's very little competitive pressure and it's a stable and positive payer environment, a very different situation than Otrexup. The product has a nice niche to complete the treatment of LGS.

Many of these children are put on a keto diet in addition to medical therapy to control their seizures. We noticed in diligence that few physicians were aware of the commonly used liquid clobazam products containing 33% or more of the daily carbohydrate limits under the restrictive keto diet.

Sympazan has just 2% of the card content that the liquid formulations have. In addition, we are excited at the opportunity to partner with the patient advocacy community which is very strong in both epilepsy and LGS. We're proud to be part of this community now and raising awareness.

November 1 was LGS Awareness Day and it also marked the beginning of epilepsy awareness month. Fourth, it fits within our commercial model. Quest have launched this product in 2018 with 30 reps. And prior to our acquisition, they had less than 10 filled territories.

We think that Sympazan will fit very nicely into our nonpersonal platform, where we can expand upon the physician reach with what is largely an educational message to treating physicians who are very familiar with the clobazam molecule already.

In terms of our goal to further diversify our business, while mathematically Sympazan does help, it was on the smaller side. As we had mentioned, we were seeing the smaller-sized acquisitions and our M&A pipeline accelerate, while the larger ones are being delayed. We are still pursuing those larger transformative transactions.

We had originally set a goal of acquiring products that brought us an additional $50 million in gross profit by 2024. The approximate $10 million from OTREXUP and now $8 million from Sympazan, we are a little over 1/3 of the way to accomplishing that goal.

We have another year to go, a deep pipeline, a favorable M&A environment and the capabilities to multitask, so I'm confident we can accomplish this goal. Finally, we're still expecting that 2022 is the pivotal year for our investment in NES. They are very close to being able to finish their NDA for submission to the FDA.

As a reminder, our investment converts to equity upon FDA acceptance of the NDA. The FDA has up to 60 days to decide whether or not to accept. We do not expect to provide any update to investors until it is known whether or not the FDA has accepted the filing. Now, I'll turn the call over to Paul to discuss our quarterly results.

Paul?.

Product net sales are expected to be greater than $141 million compared with our prior expectation of $129 million to $137 million. Adjusted EBITDA is now expected to be greater than $86 million, a considerable step up from our previous guidance of $73 million to $79 million.

The updated guidance for 2022 reflects our latest revenue, margin and operating expense expectations for the remainder of the year.

There are several moving parts, including favorable year-to-date results which include favorable SPRIX volume, favorable channel mix across the portfolio due to lower volume and unprofitable channels, INDOCIN net sales growth was driven by the new commercial and channel strategies, our exit from 340B and return to normal channel inventory levels are expected to result in a higher net product sales for INDOCIN.

And lastly, a step-up in operating expenses in the fourth quarter related to additional costs for Sympazan, Otrexup samples and additional recruiting and related employee costs.

Overall, we're once again incredibly pleased with the quarter results and cash flow from operations as they reflect continued execution of our business strategies and goals aimed at positioning Assertio for long-term sustainable growth. And now I'll turn the call back over to Matt..

Thank you, Paul and Dan. At this time, we will take questions from our research analysts and institutional investor community.

Terry, can you go ahead and provide the instructions for Q&A from our listeners, please?.

[Operator Instructions] The first question comes from Thomas Flaten of Lake Street..

Congrats on great quarter. Couple of questions. Dan, any insight into demand from the 340B hospital segment that as of October 1 no longer had access, any inclination as to how robust that demand has been? I know it's only been 5 weeks but curious to get any color on that..

Yes. It's been 5 weeks. And unfortunately, our data that would come from the wholesalers is on a lag. So we've got very little insight into that right now. But there is reason for optimism but what we're reflecting in our guidance and our plans going forward is just the cessation of those sales..

Got it. And just following up on the sampling or the samples for OTREXUP.

Is that on the glide path now? Or are there critical path items that could kind of distort that situation even further? Or do you feel pretty good about end of this quarter, early next?.

No, they're starting to deliver on time for all of our POs and those are scheduled manufacturing time lines right now..

Got it. And then 1 final one.

Anything you can share with what you're going to propose to FDA during our pre-IND meeting in terms of size, timeline, anything like that?.

What I can disclose right now is what we're proposing is that it's just a single-arm trial. So the size of it will depend upon what ultimately the FDA does want. But I think it's too premature to get into the details until we get some FDA feedback and then later on submit our IND..

And just tacking on to that, from a strategic perspective, do you anticipate any issues if you get labeled for moderate risk but there's significant utilization high risk, you don't see the payers paying more attention to this and cracking down on utilization, do you?.

I don't think so. We haven't seen a lot of payer pressure in this category. It doesn't seem to be something that is called out in addition to the procedure cost and at a full list price, this is a onetime $700 item. So I don't anticipate it's going to be a material thing for payers..

The next question on the line comes from Scott Henry of ROTH Capital..

I think I'll start with INDOCIN. First, I'm a little confused with the idea of if you pulled out of the 304B or 340B [ph] which however those numbers go together. Typically, if I'm not selling to these hospitals, that would have a negative impact on revenues.

Could you just kind of explain to me why you wouldn't be losing sales, even if they were unprofitable sales, there wouldn't be any contraction in revenues there?.

Sure, Scott. This is Paul here. Just -- I'll explain that in a little more detail. So the 340B pricing was obviously very favorable to the hospital, given where we were at in that pricing and the maturity of the product, essentially, we were at penny pricing. So when we ship the product to the wholesaler, we have to pay a wholesaler fee on that.

And then the product ultimate gets shipped downstream to the hospital at the lower price. So we were, in fact, losing money on every shipment that went out the door related to 340B. By not shipping that volume, we no longer pay the wholesaler fee on it and we end up saving money..

Okay.

So you were losing money even at the revenue line, not just at the bottom line?.

Correct. Correct. Yes..

I think that's what you're saying. Okay. All right. That's a tough business doing it that way. Okay. That makes sense. And then, I mean, obviously, Dan, one of the strengths of the company in the past couple of years has been just acquiring products going to this new selling model and rents and repeat.

Getting back into the R&D business, everyone is not -- doesn't have the same core competencies.

How comfortable are you that you can be successful running clinical program or not just successful but as successful as you've been with the other business model?.

It's a very good question, Scott. And One of the things that we're doing is we're adding to the team.

We are actively recruiting for Head of Medical, who will help us not only with the INDOCIN clinical but with some of the other opportunities that we see in our current portfolio and especially with the addition of Sympazan and the opportunities we see there.

In terms of the additional risks or things like that, this is not a -- we're not going back to the bench and we're not dosing in mice here. We're basically just doing a confirmatory trial that will already confirm ideally what some of the other clinicals have done that the NIH and others have sponsored..

Okay, fair enough. And then with regards to Otrexup, we've got a couple of quarters under the belt. Do you think long term that can get to and by long term, I mean, in the next year or 2. So maybe medium term would be better.

Does that could get to $4 million a quarter run rate or are we looking at kind of $3 million to $3.5 million? It sounds like we're a little over $3 million right now..

Yes. We're a little over $3 million right now. I don't think it's too big of a stretch to get to $4 million from where we are now. So longer term, I still think the opportunity is there. certainly, the potential is to be able to double this product when you've got a 20 share in this market.

And medium term, we're not making any product specific or even forward-looking guidance for the whole company but I don't think it's out of the realm of possibility to be able to grow that product like you're suggesting..

Okay. All right. Great. And then on Sympazan, how should we think about amortization expense for that? I guess, it will be the whole, I want to say, $15 million or $16 million.

What should we amortize that over what time frame?.

$16 million over 10 years. So you're looking at $1.6 million a year..

Okay. And have you said about the gross margin profile? I know I can probably back into it with some of the guidance.

But is it similar to your other products or higher or lower, I guess, just to make sure?.

It's a little lower. It hovers in the high 70s or around 80% gross margin..

The next question on the line comes from Mitra Ramgopal of Sidoti..

First on Sympazan, I was just wondering if you have to make some additional investments to support the growth there.

I believe you mentioned some personnel additions and some of that might be for Sympazan but just curious if there are some additional investments that we should be expecting here?.

There's nothing incremental that we've got in the plan right now. There are some things that we're exploring.

It might be some very small and simple PK tight clinical studies to support some of the things that we saw and had heard during diligence but there isn't any -- other than the samples you need for this product and the FDA PDUFA fees, it's just the addition to our existing commercial platform..

Yes. And Dan, you mentioned, I believe you added about 8 [ph] in terms of head count. As you look out to 2023 and with Sympazan and expectations on NES, et cetera.

Do you expect to be even more aggressive on that front? And how is the labor market in terms of maybe having to pay up a little?.

We haven't seen -- we haven't had to -- hopefully, my employees aren't listening. We haven't had to pay up yet but there's, I think, 3 additional physicians that are in the org chart that are approved right now. One is the Head of Medical that I mentioned and then the rest are more bench strength.

But the -- we don't have aggressive hiring plans and we've seen that we can offer a pretty attractive package to convince people to join Assertio..

Okay. And then just coming back to the BD opportunities.

If you can give us a sense in terms of what you're seeing out there as it relates to competitive better valuations and maybe your expectation in terms of being able to close a few of those deals over the next year?.

Like the prepared comments, we still see a very active BD pipeline. And as I speak, we're -- we've got the capabilities to evaluate multiple at the same time and we are evaluating multiple currently. So we feel very confident that we're going to be able to meet our goals and hopefully exceed our goals like we always try to do.

And what we have been seeing is that these situations are not that competitive. There might be 1 or 2 that are hanging around the hoop but they're we've been able to win each of the situations that we intended to win.

So the valuations that we saw, like the Sympazan transaction is a very good 1 where not a lot of competition for assets like this and you can acquire them at very attractive prices. And we're seeing that in the others that we're looking at as well..

Okay. And then just the criteria, I think Sympazan is going to be accretive very quickly.

Is that 1 of the things that you look at as you do these deals aside from must have nice revenue, attractive end market, et cetera?.

Yes. So we're always looking to do something that's accretive, at least for the time being with the business that we've got until we can diversify our overall revenue. So that is a core objective that we're looking for when we acquire something.

The other component that we do is we do a cash on after-tax cash return where we're targeting north of 20% in an IRR..

Okay. And just finally, just on litigation feed, et cetera. Nothing -- it seems like it's pretty quiet on that front.

I'm assuming there's nothing really to report there?.

Pyes, there's been no movement at all. As far as I'm aware, we don't have any cases progressing..

The next question comes from Hamed Khorsand of BWS Financial..

Could you just talk about what your expectations are with Sympazan.

Is it made for you as far as revenue is concerned? And what are your plans as far as doing the digital marketing for and what your expectations are with payers?.

In terms of the -- to answer the last question first, we intend to just move the existing Aquestive payer contracts over to Assertio and are not expecting any material changes. We'll evaluate bidding on additional business there as things move forward, likely right now, it's the 2024 bidding cycle that people are working on.

But what we saw there was a very favorable payer environment and stable payer environment. So we're actually encouraged with this asset. It will be a simple add this into the existing commercial infrastructure for the nonpersonal and digital platform. There will not be a lot of extra things required.

The only thing different about this product from some of our others will be the patient advocacy communities that we're going to be taking a large part in. But other than that, it's a -- we're starting to sell already for this product. And because of the partial quarter, we've guided that we'll do at least $1 million in the fourth quarter for it..

[Operator Instructions] The next question comes from Scott Weis of Senko..

Great quarter. Congratulations. I have 2 questions for you.

In your opening comments, you indicated that this quarter is reflective of a shift to growth mode and I want to ask, does that mean that you can show growth in '23 versus '22?.

That is my goal, Scott. So that's part of the objectives that I have. We're not giving guidance for what 2023 is. We're updating what we had previously said. But that is our goal to be able to grow this to -- grow this business..

Okay. My second question is around INDOCIN and you made a comment about going direct with INDOCIN. And I wanted to see if you could flesh that out a bit.

How would that impact the relationship that you currently have with distributors? What were the margins on the direct business be? Can you talk a bit about that, please?.

There's a large cushion between what the list price and what we ultimately get from a wholesaler and what the end customer is paying. So there's a large cushion where we can offer some discounts to make it attractive to them to purchase directly from us. The margins won't be materially different. It could be very close to the same.

And the only additional thing that we're taking on is additional shipping costs and collections risk from the customer..

Okay.

And so then how does going direct benefit you bypassing the wholesalers?.

It's more of a direct relationship with your customer and the ability to service them with priority..

We currently have no further questions. So I hand it back to Dan for any closing remarks..

Thank you. In conclusion, the third quarter was one of our most important strategic quarters for Assertio as we're now poised to accelerate the growth of our company.

We extended our debt maturity, improved our margin profile on a key asset, added a new asset via highly accretive transaction and continued to generate cash flow that will fuel our strategic plans to diversify, enhance and enhance our asset base. Appreciate you all taking the time to join our call and hope you all have a good evening. Thank you..

This concludes today's call. Thank you all for joining. You may now disconnect from the call..