Assertio Holdings, Inc.

Good morning and welcome to the Assertio Holdings, Inc. Third Quarter 2023 Financial Results Conference Call. All participants will be in listen-only mode. After today's presentation, there will be an opportunity to ask questions. Please note, this event is being recorded. I would now like to turn the conference over to Matt Kreps from Darrow Associates Investor Relations for Assertio. Please go ahead.

Good afternoon, and thank you all for joining us today to discuss Assertio's third quarter 2023 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 tables in conjunction with today's discussion. With me today are Dan Peysert, President and CEO, A.J. Patel, Chief Accounting Officer and now Chief Financial Officer and Paul Schuchtenberg, previously our CFO, and now Senior Vice President in a new role overseeing market access, pricing, trade, and distribution, and other commercial activities. Dan will open the remarks and provide an overview of the business, and Paul and AJ 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 guaranteed of future performance and involve risks and uncertainties. including those noted in this morning's press release, as well as the CERTIO's filings at the SEC. These and other risks are more fully described in the risk factor 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 the CERTIO specifically disclaims any intent or obligation to update those forward-looking statements except as required by law. And with that, I will now turn the call over to Dan.

Thank you, Matt. Welcome to everyone joining us this afternoon.

I am not pleased by our results in the third quarter. We did not meet the expectations nor the goals we set for our business. And these results, these aren't the results that we know you as shareholders have come to expect from us. While disappointing this quarter, I've been reminded that business transformations rarely go smoothly and they're not linear. We put ourselves on this path to build a stronger business so that we could weather these challenges. And this is one we will work our way through. Even though the reported sales for Rolodon were significantly below our internal expectations in the quarter, when viewed with the launch of a generic competitor for Indusim, the rationale for the merger and our commitment to diversification are evident. In addition, the Rolodon team brings enhanced competencies in market access and field reimbursement support. that are part of our broader strategic vision for the future. We'll also continue to leverage our non-personal promotional model, which to date has been instrumental in our turnaround, allowing us a significant expansion of operating margins and improved operating cash flows. I've listened to many of our peers' earnings calls for this and prior quarters, many of whom are struggling with their operating models as it relates to achieving profitability and positive operating cash flows. This is where Assertio clearly has set itself apart. Despite the disappointing top line results this quarter and the one-time cost associated with the completion of the Spectrum merger, we still reported positive income on a non-gap adjusted EBITDA and EPS basis and positive operating cash flows. In addition, our balance sheet and liquidity position are the strongest it has been since I've joined the company. We're now in the greatest sustainable net cash position the company's experienced in the last six years. Our debt isn't due for just under four years. The rate we're paying is only 6.5%, and we have no covenants on our debt. This is remarkably important to continue this transformation. In addition to stabilizing our base business, especially Induson, and putting our long-duration assets in Rovodan, Simpazan, and Atrexa on a path to growth, We need to acquire additional assets to continue to diversify our business and find other avenues for longer-term growth. The business environment for acquiring assets is as strong as I've seen it in my career, and we're well-positioned from both a balance sheet and platform perspective to take advantage of this environment. Today, we're also announcing some changes to our management team that will help us both for the short and long term. Paul Schwichtenberger will be handing over the CFO duties to AJ Patel, our current chief accounting officer, and Paul will be taking on a new role in the organization with direct oversight for market access, pricing, trade, and distribution. In addition, on an interim basis, while we're recruiting for a new team leader, Paul will oversee the oncology commercial team. This will allow for us to have more direct management input into the key areas that affect our gross net and cash flows, and are critical to the operations of our business going forward. We will also be adding a few other key roles to the organization so that we can effectively manage the volume of external growth opportunities available to us while not taking the focus off the day-to-day operations of the business as we increase our business development efforts. Both Paul and AJ have been critical to our success to date I am confident they'll be catalysts for future success as well in their new and expanded roles. Before I hand the call over to Paul, I'll walk through some of what we saw in the business this quarter. We will not be providing business or guidance today. However, we will try to provide some general commentary on how we're internally projecting the business to give you some context as you refine your own forecasts and models. With respect to Indusit, We're only three months into the generic launch, and this market is not yet stable. The decline in sales experienced in the quarter is primarily attributed to volume losses to both the generic and a compounded version of the product. Relative to what we initially assumed for just a single ANDA competitor, the market has been more competitive on pricing, which we believe has been driven by the compounder and the FDA's recent decision to add Indomethacin to the Category 1 list. which effectively means the FDA will not pursue regulatory action against the compounder while it's on that list. We're pursuing all available remedies to have this product removed from the market. We've built an erosion analog made up of more than 20 recent generic introductions for non-retail products and weighted them based on a variety of factors, such as dosage form, number of competitors at market formation, and the price of the drug. There's a good deal of variability amongst each of these individual erosion curves, and there's also no situation just like ours. For example, no suppository with this competitor at this price, and there isn't any good reliable data for erosion versus an illegal compounded product. This remains very fluid, but those analog curves do show that the brand can retain between one-third to one-half the market volume, even out to year two after competitive entry. So, we believe this remains an attractive market for Asserdio. With respect to Rolvidon, our understanding of the dynamics at play here is still evolving. And no matter the answer about what is in the rearview mirror, we are single-mindedly focused on maximizing long-term value for this brand. As many of you are aware, the sales pattern for the drug has been very back-end weighted towards the end of the quarter after ASPs are published, leading to lower than typical visibility and quarterly performance. This quarter was not much different. In the two quarters we own the product, or the two months that we own the product, we reported $7.1 million in revenue, and for the full third quarter, $8 million of Rolodon was sold. The shift in reimbursement to the permanent J code in April does not appear to have benefited demand as much as was anticipated, both for existing and new customers. This demand trend was masked by changes in underlying inventory, largely at the end customer level. That in aggregate was approximately three months at the end of Q1, which grew to four months at the end of Q2. And now at the end of Q3, we calculate to be less than two months of demand. Customers had been offered short-term incentives, which allowed them to hold this much inventory. Sertio did not offer most of these incentives in Q3 and does not intend to continue offering them to customers. This may have a further impact on Q4 volumes, the extent of which is not known or estimable at this time. While this is a competitive and dynamic market, it is still very attractive, and we're committed to maximizing Rolvidon potential. In addition to removing those short-term incentives that can negatively affect ASPs, working capital, and cash flows, we're rethinking customer targeting and broadening the customer base. In addition, we're evaluating our strategy with respect to payer coverage. Beyond the commercial strategy and tactics, the lifecycle development of Rolodon is also being entertained. Robodon is a differentiated molecule. It's the first novel product to enter the long-acting GCF space in over 20 years that is not a biosimilar. It also may have utility in different dosing algorithms and chemotherapeutic regimens it hasn't been studied in yet. One example is same-day dosing. We have elected to continue enrolling into the expansion phase of the ongoing open-label phase one same-day dosing trial and move the management of the trial to a CRO. We've already noticed an acceleration in the enrollment rate based upon some of the changes we've made. At the pace enrollment had been moving, the data would not have been available until late 2025 or early 26. We're looking to materially improve upon those timelines, and once we get a better estimate of the recruiting cadence, we'll be able to communicate those timelines to shareholders. I'll now turn the call over to Paul.

Thank you, Dan. This afternoon, I will review the financial highlights from Assertio's third quarter of 2023. For full details, please refer to the tables and financial statements in our earnings release and 10Q. Net product sales were $35.1 million for the third quarter of 2023 compared to net product sales of $34.3 million in the prior year quarter and $40.1 million last quarter. The increase in net sales versus the prior year quarter is primarily driven by the additions of Rolvidon and Simpazan, which were mostly offset by declines in Indison and Cambia following their respective generic entrants. Indison family net sales in the third quarter decreased by 18% from the prior year quarter, primarily due to the generic entrant in the quarter. Rolvidon net product sales were $7.1 million for the two months following the acquisition of Spectrum. Our initial assessment indicates that there were several dynamics that impacted the third quarter. The early launch benefited from favorable reimbursement, expectations for a demand increase from a permanent J-code effective April 1st, which had not been achieved, and there were high levels of inventory in the channel at the end of the second quarter. Net ASP in the third quarter was down 14% versus the prior year quarter due to short-term incentives that were offered to customers. We're no longer offering these incentives, and as a result, expect that the net ASP will stabilize or improve in the fourth quarter. Otrexit net sales for the third quarter were $2.8 million versus $3 million in the prior year quarter, reflecting unfavorable channel nets partially offset by higher volumes. Simpazan net sales of $2.1 million in the third quarter reflected a 4.2% increase in prescription volume and lower channel inventories at the end of the quarter. Overall, portfolio net sales were up 3% versus the prior year quarter, despite the Cambia loss of exclusivity in January and Indison in August. Gross margin as a percentage of product net sales was 80% in the third quarter, versus 88% in the prior year quarter. Inventory step-up amortization for Rolvidan was $1.8 million, which contributed a 500 basis point decrease with the balance of the change primarily reflecting changes in sales mix due to declines in Indus and Cambia. SG&A expenses were $21 million in the third quarter, compared to $16.8 million last quarter and $11.9 million in the prior year quarter. Adjusted SG&A was $16.2 million in the third quarter compared to $10.9 million in the last quarter and $9.3 million in the prior year quarter. The increase in adjusted SG&A versus the prior year quarter is primarily due to additional operating expenses from the SPAC to merger and prior Sympazan and Attrexac acquisitions. We are continually evaluating our operating expenses to ensure that we have optimal support for each of our products. We have seen synergies between the Assertio and Spectrum businesses and believe that we can operate with less than the $55 million of incremental operating expenses previously communicated. Additionally, as we've done in the past, we continue to look for opportunities to reduce spending in light of revenue changes while ensuring that we have the infrastructure in place to support the entire portfolio along with future business development opportunities. Adjusted EBITDA for the third quarter was $12.9 million compared to $24.8 million last quarter and $21.4 million in the prior year quarter. The year-over-year decrease is primarily driven by higher operating expenses from the additions of Robodon and Simpazan. At this point, I will hand the call over to A.J. Patel, our Chief Accounting Officer and newly appointed Chief Financial Officer, who will discuss net income which was impacted by specific one-time accounting adjustments recorded during the quarter, along with cash flows and the third quarter balance sheet.

Thanks, Paul. Let me first acknowledge my appreciation to Paul for all his contributions to Assertio during his tenure as CFO. I look forward to our continuing partnership. Moving along in the P&L results, our third quarter was impacted by several non-cash items. First, there was a $238.8 million impairment charge to intangible assets. This was triggered by a decline in our stock price during the quarter, which led to our market cap being less than our book value. Under GAAP, this impairment trigger requires us to assess the fair value of our assets using both an income and market approach. We utilized various estimates and assumptions, including forecasted cash flows and market comps. This resulted in an impairment charge to intangible assets at a consolidated level, which was then allocated across the individual product rights. Second, there was a $17.5 million benefit in the quarter from change in fair value of our contingent liabilities compared to a loss of $3.9 million in the prior year quarter. The magnitude of the benefit in the quarter was primarily driven by revaluation of the indecent contingent liability due to generic entry. Finally, income tax expense of $50.7 million in the quarter was impacted by a $43 million charge for valuation allowance against deferred tax assets based on an assessment of their realizability. Our total cost in the third quarter also included 3 million in restructuring charges related to a reorganization plan of our workforce and resources following the acquisition of Spectrum. Inclusive of these items, there was a gap net loss of 279.5 million in the third quarter compared to net income of 4.2 million in the prior year quarter. The adjusted EPS was one cent in the third quarter versus 19 cents in the last quarter and 22 cents in the prior year quarter. EPS in the third quarter was impacted by the 38 million shares issued in connection with the acquisition of Spectrum. Cash generated from operating activities in the third quarter was 2.6 million versus 18.6 million in the last quarter and 10 million in the prior year quarter. The third quarter operating cash flows were impacted by transaction costs and immediate working capital needs from Spectrum acquisition. Cash balance at the end of the third quarter was $76.9 million, reflecting a $6.7 million increase from the last quarter. Our outstanding convertible debt balance at the end of the third quarter was $40 million and does not mature until September 2027. And now I will turn the call back over to Matt.

Thank you, Dan, Paul, and AJ. At this time, we have completed our prepared remarks, and we'll use the balance of our allotted call time to take questions, starting with our sell-side analyst community. Operator, can you please provide the instructions for Q&A from our listeners and take the first question?

Thank you. If you would like to ask a question, please press star, then the number one on your telephone keypad to get into the question queue. Again, that is star, then the number one to ask the question. And your first question comes from the line of Thomas Blatton with Lake Street. Thomas, please go ahead.

Hey, good afternoon, guys. I appreciate you taking the questions. I was curious if maybe we could drill down on Induson a little bit. I know there was some inventory adjustment going on at the wholesalers And if you just look sequentially from the second quarter of this year, there was obviously about a $10 million drop-off. Is there a way of maybe breaking out how much the inventory adjustment accounted for there that I would maybe class as kind of a one-time event versus the impact from the generic and the compounder?

I don't think we have a good answer in terms of dollars, but there was a an impact, you could expect that they want to make shelf space available for another product in the marketplace. And there's the same level of demand that was there. But I don't think we have a good number in terms of the dollar sales impact.

No, we don't. Thomas, we don't have a breakout of the The specific inventory adjustment that Dan just referenced, the situation is that with the generic entrant, our volume is coming down. It's really all tied to the generic entrant and our volume primarily. And as a result of that, the wholesalers take the inventory levels down. But we view it as all kind of driven by the generic entrant and lower volumes.

Got it. And then... do you have a sense of, and I know the data is a bit hard to come by given that some of your data is blocked, but do you have a sense of market shares, compound or generic versus yourselves kind of against that erosion curve that you talked about? Are we ahead of the curve or behind the curve, so to speak, from an erosion perspective?

The answer to that is long, but to try and sum it up, the The way we're estimating what the compounder might have taken is to just assume a flat or slightly increasing overall market and then add up what the prescription data reporting services tell us is the new market. And the delta is what we assume the compounder has taken. So I would say relative to the analog I explained, we were tracking slightly below it, but within statistical control of it. The biggest impact that we've seen in the marketplace was the pricing. And that really is, you have a two-competitor market instead of a one-competitor market, as we had originally assumed.

Got it. And then just one final one, and I'll jump back in the queue. The short-term incentives that were offered to the Rolvidon customers, could you maybe explain that a little bit more? And were they offered by you or by Spectrum prior to the closing of the deal?

So the incentives were offered by Spectrum largely for the second quarter. There was a variety of them, but the one that I can explain that in general terms is the Roughly half of the gross sales reported in the second quarter by Spectrum were collected by Assertio until the first week in November. And there were prompt payment terms offered on those sales. So that is a practice that we will not be continuing.

Got it. I appreciate it. I'll jump back in the queue. Thanks.

Great, thank you. Your next question comes from the line of Jim Sidoti. Jim, please go ahead.

Hi, good afternoon. And I know there's a lot of moving pieces going on and you're not prepared for any kind of formal guidance, but you had previously given us an idea of where you think Robodon would go over the next couple years. Do you have any sense now on, you know, now three months later where you think those numbers are?

No, we're not in a position to give any kind of point estimates on what it's going to be. And we fully appreciate that investors want to know this, not only just for Rovedon, but for our overall business. And we'd like to be in a position to communicate that. But I think as we said in our prepared remarks with some of the puts and takes around demand, removal of these incentives, what that also might mean for ASPs, that it's in flux right now, and we need to get a good handle on things before we communicate a point estimate to investors going forward. The long and short of it is, though, we are absolutely committed to maximizing the long-term potential of this brand.

Can you comment? Have you changed any of your thoughts regarding the direct sales force and your plans for that? And also for the R&D investment to expand the market for Robidon. Are you still going full speed ahead with those two initiatives?

Any changes that we've made to the commercial team have already taken effect. Nothing else is anticipated at this time. And R&D, as we said, there's two active trials right now. There's one in same-day dosing that I described in my prepared remarks, and there's another pediatric post-approval commitment that we're enrolling in as well. Those are the two trials for Rolodon that are underway, but as I said, there are other things outside of what the product has already been studied in that are in additional dosing as well as other hemotherapeutic regimens that we are exploring that the product hasn't been studied in yet.

All right, and then the last one for me is, you know, how active are you right now out looking for additional deals? Are you focused on resolving some of the issues with Spectrum, or does this actually, you know, incentivize you to go out and find additional products?

Well, there's two focuses that the business has. One is making sure that we have got the business on a stable footing. And the other is making sure that we can bring additional assets into the business. The combination of What we saw here in the third quarter with respect to Rolvidon, as well as what we knew was coming with the Indus and Generic that was launched in August, those have caused us to accelerate our business development efforts. So that's part of the reason why we're announcing this change here with Paul and AJ and their roles. And we're bringing on some additional resources to help us manage the overall Sertio-based business that will Give us additional heads to evaluate more BD opportunities. And the big message that you should take away there is there are a lot of opportunities in front of us. And we want to make sure that we can choose the best ones of the bunch and get them completed. Because Asurdio is in a very good position to capitalize on those opportunities.

That was it for me. Thank you.

Thank you. And just as a reminder, if you would like to ask a question, please press star, then the number one on your telephone keypad. Your next question comes from the line of Scott Henry with Ross Capital. Scott, go ahead.

Thank you. Good afternoon. Where to start? I guess On Indosyn, I feel like you've given us a lot of information. The only thing that I would be curious is if you look at kind of the last month, last two or three weeks, do you have a sense of where the product is annualizing sort of in real time?

Scott, that...

We'll be at a better position to answer that at a later time. Right now, we're not going to be giving any type of guidance. We wanted to frame it up with some general commentary about how we're looking at things and evaluating this, but that is the best that we can do at this time.

Okay. Then I just come at it a little different, and I do think you gave us some good information to open the call about where typically... we would see a curve like this happen. What kind of steepness, you know, if we're going from point A to point B, do you think it's going to happen relatively quick? Or, you know, is that slope more gradual? Just, you know, trying to get any sort of color on it.

That is, I think, the $20 million question and where the crystal ball is. is is murky's got so that is the the number one thing that makes these analogs diverse is is the steepness of that curve they all seem to have a little bit more consistency once you get out and it's not an asymptote when it's still at a third to half the business but when you get out towards the the later months that they get more predictable So it's the steepness of the curve in the beginning that is the main variable.

OK. Thank you. I mean, nothing more to ask on endosyn. Rolvidon, it's hard to miss the irony of all this. They got a generic to endosyn, and you got a full channel. I think you got the better deal still. The question is, when we think about the third quarter, the $7.1 million is what you sold, but there's a reduction in the channel. Do you have a sense of what the demand was for in Q3? Should we add another month to that number? Just trying to get a sense of, on an apples-to-apples basis, where we should think about that Q3 number.

I think that's a good question. We're still working through that ourselves. We tried to give you guys enough. Based on what we know today on those how the months on hand has kind of. Changed as well as Paul gave you commentary on how the ASP changed. The the hard part for us is is. Change your I guess. removing all those factors and getting at what is the true underlying demand and how much could those factors change in the future still. So we're still looking through that ourselves here in the short run, but the take home message is that we've already made concrete steps to improve the product in the short term and set it up for a better long term.

Do you think it's, I mean, this is saying very little, but do you think it's safe to say Q4 should be higher than Q3?

That would be our goal, but there are both pluses and minuses on both the volume and pricing side that we have to get through. And like I said, The visibility on this product, I'd like to be able to give you what my October was relative to the July. But that will not help much. This comes down to what's going to happen in the last couple of weeks. And right now, we don't have a good visibility into that. So I don't want to provide forward-looking guidance on that.

Okay. And maybe just another way to ask a similar question. It seems like you had the accountants working overtime, doing write-downs, restructurings. Did you evaluate Rolvidon for impairment or did you not? Not enough information at this point. Just trying to get a sense if you view the short-term issues as potential for long-term impairment or maybe it's just too early to even think about that.

Yeah, Scott, this is AJ. I can take that. So our impairment evaluation was done at an entity-wide level. So all of our product rights groups were evaluated for the impairment. And as I had stated in my comments, the impairment charge was taken at the consolidated level and then allocated to each of the product rights.

Okay. And if I recall, you did not allocate any to Rolvidon, correct?

No, there will be an allocation to Rolvidon.

Okay. Thank you. And then, Dan, this is a tougher question, too. I don't know how you'll want to answer it, if at all. But without giving guidance, aspirationally, would you look for EBITDA adjusted for this 12-9 to be a lower point or a baseline? Or could it get worse? Just trying to think about that. because we should have Rolvidon getting better. We should have the other products getting better. And in this end, there'll be some hits there, but a lot of that's been taken. Just any way you could think about this kind of baseline EBITDA.

Yeah, Scott, that's not a question I can answer at this time.

Okay, fair enough.

I do appreciate why you're asking, and I really wish I could give you that visibility. I just at this time.

Now, fair enough. I understand. But that's why we ask them. I guess Otrexip and Sempes Amp, they were down in Q3. They were pretty strong in Q2. Is it fair to say that the trend is somewhere in between those? I mean, do you still expect those to be growing products? Just some timing here?

Yeah, Scott, I think the trend is somewhere in between the two quarters. As we mentioned, as I mentioned in my script, Simpazan prescription volume continues to increase. It was impacted a little bit by changes in wholesaler inventory levels, and Otrexip is still kind of tracking along at kind of in between the two-quarter level, as you mentioned.

Okay. Great. Thank you for taking the questions. Thanks, Scott. Sure.

Thank you. And your final question comes from the line of Thomas Blackton with Lake Street.

comment please go ahead yeah hey guys um i guess i didn't ask it explicitly but are are you guys being forced into situations where you're price matching the lower prices with with your indesign accounts or how how exactly is the pricing in the market impacting you at kind of an account by account level uh that's a good question it's not account by account it's more like at the wholesaler level if your competitors are at a far lower price then

they're obviously going to take the business just straight from you. So that's what you're going to see like at a Symphony or IQVIA type basis. That's more what we see at the wholesaler. Got it. On the account by account basis, or if anyone's doing any GPO contracting or things like that, you can have some individual negotiations, but we've been... We've been pretty strong on any individual account in terms of retaining demand. But that is where you're seeing, I think, the greatest impact and why we think it is from the compounder is the overall price in the market is lower. But all the things that we hear about where the generic is being priced isn't as low as what we're hearing the market clearing price is.

Do you have an update for us from the 5% off of WAC, which is, I believe, where Zytus started? Where are we at now in the market, approximately?

From a trade show, the lowest screenshot or handout that we've seen is 9% off. We've heard of other things in the market that were slightly less than that, but we think that that is what In the general ballpark of where the generic is, the other numbers that we're hearing we think are all coming from the compounded product.

Got it. I appreciate you taking the follow-up.

Great. Well, thank you so much. We have no further questions in the queue, so we're going to go ahead and close our Q&A section at this time. I would now like to turn the conference back over to Dan Peisert, President and Chief Executive Officer, for closing remarks.

Thank you. I said this last quarter, and it's still true today. We are a far stronger company than we were a few years ago, and I believe we are well positioned to come through this even stronger and create value for all stakeholders. Paul, AJ, and I speak for the collective 70 employees of Assertio. We are not here just for a quarter or two. We're here for the long term, committed to building what we all think can be a special company and, over the long term, an attractive investment for our shareholders. Thank you and have a good night.

Thank you, ladies and gentlemen. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.