Assertio Holdings Inc

NASDAQ:ASRT

Earnings Call Transcript 2023-Q3

[Operator]

Good morning, and welcome to the Assertio Holdings, Inc. Third Quarter 2023 Financial Results Conference Call. [Operator Instructions] 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.

[Matthew Kreps]

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 Peisert, President and CEO; Ajay Patel, Chief Accounting Officer and now Chief Financial Officer; and Paul Schwichtenberg, 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 Ajay 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 Acorio 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.

[Daniel Peisert, executive]

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 ROLVEDON were significantly below our internal expectations in the quarter, when viewed with the launch of a generic competitor for INDOCIN, the rationale for the merger and our commitment to diversification are evident. In addition, the ROLVEDON 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 nonpersonal 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 onetime costs associated with the completion of the Spectrum merger, we still reported positive income on a non-GAAP 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 has experienced in the last 6 years. Our debt isn't due for just under 4 years. The rate we're paying is only 6.5%, and we have no covenants on our debt. This is remarkably important as we look to continuous Assertio's transformation.

In addition to stabilizing our base business, especially in dose and putting our long-duration assets in ROLVEDON, Sympazan and Otrexup 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 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 Schwichtenberg will be handing over the CFO duties to Ajay 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, follow oversee the oncology commercial team. This will allow for us to have more direct management input into the key areas that affect our gross to 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 Ajay have been critical to our access to date, and I am confident there'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 our 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 forecast and models.

With respect to INDOCIN, we're only 3 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 nonretail 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 is 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 analogs do show that the brand can retain between 1/3 to 1/2 of the market volume even out to year 2 after competitive entry. So we believe this remains an attractive market for Assertio.

With respect to ROLVEDON, our understanding of the dynamics at play here is still evolving. And no matter the answer about what is in the review 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 2 quarters we own the product or the 2 months that we own the product, we reported $7.1 million in revenue and for the full third quarter, $8 million of ROLVEDON 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 3 months at the end of Q1, which grew to 4 months at the end of Q2, and now at the end of Q3, we calculate to be less than 2 months of demand. Customers have been offered short-term incentives, which allowed them to hold this much inventory. Assertio 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 ROLVEDON 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 and life cycle development of ROLVEDON is also being entertained.

ROLVEDON is a differentiated molecule. It's the first novel product to enter to the long-acting GCF space in over 20 years that is not similar. It also may have utility in different dosing algorithms and chemotherapeutic regimens that 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 I same-day dosing trial and to 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 hadn't been moving, the data would not have been available until late 2025 or early '26. We're looking to materially improve upon those time lines. And once we get a better estimate of the recruiting cadence, we'll be able to communicate those time lines to shareholders.

I'll now turn the call over to Paul.

[Paul Schwichtenberg, executive]

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 10-Q.

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 ROLVEDON and Sympazan, which were mostly offset by declines in INDOCIN and CAMBIA following their respective generic entrants. INDOCIN family net sales in the third quarter decreased by 18% from the prior year quarter, primarily due to the generic entrant in the quarter.

ROLVEDON net product sales were $7.1 million for the 2 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 demand increase from a permanent J-Code effective April 1, which have 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.

Otrexup net sales for the third quarter were $2.8 million versus $3 million in the prior year quarter, reflecting unfavorable channel max, partially offset by higher volume. Sympazan 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 INDOCIN 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 ROLVEDON 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 INDOCIN 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 Spectrum to merger and prior Sympazan and Otrexup 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 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 opportunity 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 was primarily driven by higher operating expenses from the additions of ROLVEDON and Sympazan. At this point, I will hand the call over to Ajay Patel, our Chief Accounting Officer; and newly appointed Chief Financial Officer, who will discuss net income, which was impacted by specific onetime accounting adjustments recorded during the quarter along with cash flows and the third quarter balance sheet.

[Ajay Patel, executive]

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 noncash 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 INDOCIN 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 GAAP 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 $0.01 in the third quarter versus $0.19 in the last quarter and $0.22 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.

[Matthew Kreps]

Thank you, Dan, Paul and Ajay. 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?

[Operator]

[Operator Instructions] And your first question comes from the line of Thomas Flaten with Lake Street. Thomas please go ahead.

[Thomas Flaten, analyst]

I was curious if maybe we could drill down INDOCIN 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 onetime event versus the impact from the generic and the compounder?

[Daniel Peisert, executive]

There was -- 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.

[Paul Schwichtenberg, executive]

No, Thomas, we don't have a breakout of the specific inventory adjustment that Dan just referenced. The situation is that with the generic trend, our volume is coming down. It's really all tied to the generic entrant in 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.

[Thomas Flaten, analyst]

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, compounder 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?

[Daniel Peisert, executive]

The answer to that is long. But to try and sum it up, 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 as 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're 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, do you have a two competitive market instead of a one competitor market as we had originally assumed.

[Thomas Flaten, analyst]

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 ROLVEDON 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?

[Daniel Peisert, executive]

So the incentives were offered by Spectrum for -- 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 elected 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.

[Operator]

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

[James Sidoti, analyst]

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 ROLVEDON on would go over the next couple of years. Do you have any sense now on now 3 months later, where you think those numbers are?

[Daniel Peisert, executive]

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 ROLVEDON 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, the 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. But long and short of it is, though, we are absolutely committed to maximizing the long-term potential of this brand.

[James Sidoti, analyst]

Great. 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 ROLVEDON? Are you still going full speed ahead with those 2 initiatives?

[Daniel Peisert, executive]

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 2 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 2 trials for ROLVEDON that are underway. But as I said, there's -- there are other things outside of what the product has already been studied in that are in additional dosing as well as other chemotherapeutic regimens that we are exploring that the product hasn't been studied in yet.

[James Sidoti, analyst]

All right. And then the last one for me is 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 incentivize you to go out and find additional products?

[Daniel Peisert, executive]

Well, there's 2 focuses that the business has. One is making sure that we have -- we 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 ROLVEDON as well as what we knew was coming with the INDOCIN 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 Ajay in their roles and we're bringing on some additional resources to help us manage the overall Assertio 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 Assertio is in a very good position to capitalize on those opportunities.

[Operator]

[Operator Instructions] Your next question comes from the line of Scott Henry with ROTH Capital.

[Scott Henry, analyst]

Where to start. I guess on INDOCIN, 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 months last 2 or 3 weeks, do you have a sense of where the product is annualizing sort of in real time?

[Daniel Peisert, executive]

Scott, that we'll be in 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.

[Scott Henry, analyst]

Okay. Then I just come out at 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, if we're going from point A to point B, do you think it's going to happen relatively quick? Or is that slope more gradual? Just trying to get any sort of color on it.

[Daniel Peisert, executive]

That is, I think, the $20 million question and where the crystal ball is murky Scott. So that is the #1 thing that makes these analogs diverse 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 1/3 to half the business, but when you get out towards the later months that they get more predictable. So it's the steepness of the curve in the beginning that is the main variable.

[Scott Henry, analyst]

Okay. Okay. I mean, nothing more to ask on INDOCIN. ROLVEDON, it's hard to miss the irony of all this. They got a generic to INDOCIN and you've 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?

[Daniel Peisert, executive]

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 and those -- how the months on hand has kind of changed as well as Paul gave commentary on how the ASP changed. The hard part for us 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. Could the take-home messages that we've already made concrete steps to improve the product in the short term and set it up for a better long term.

[Scott Henry, analyst]

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?

[Daniel Peisert, executive]

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 those 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.

[Scott Henry, analyst]

Okay. And maybe just another way to ask a similar question. It seems like you had the accountants working over time, doing write-downs, restructurings. Where did you evaluate ROLVEDON 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?

[Ajay Patel, executive]

Yes, Scott, this is Ajay. I can take that. So our impairment evaluation was done at an entity-wide level. So all of our product rights groups were value weighted with impairment. And as I had stated in my comments, the impairment was charge was taken at the consolidated level and then allocate it to each of the product rights.

[Scott Henry, analyst]

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

[Ajay Patel, executive]

No, there will be an allocation to ROLVEDON.

[Scott Henry, analyst]

Okay. And then, Dan, this is a tougher question to. 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 be worse? Just trying to think about that because we should have ROLVEDON getting better, we should have the other products getting better and INDOCIN, there will be some hits there, but a lot of that's been taken. Just any way you could think about this kind of baseline EBITDA?

[Daniel Peisert, executive]

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

[Scott Henry, analyst]

Okay. Fair enough. I guess...

[Daniel Peisert, executive]

I do appreciate why you're asking and I really wish I could give you that visibility. I just can't at this time.

[Scott Henry, analyst]

No, fair enough. I understand, but that's why we ask them. I guess Otrexup and Sympazan, they were down in Q3. They were pretty strong in Q2. Is it fair to say that the trend is somewhere in between though? I mean do you still expect those to be growing products, just some timing here?

[Paul Schwichtenberg, executive]

Yes, Scott, I think the trend is somewhere in between the 2 quarters. As we mentioned -- as I mentioned in my script, Sympazan prescription volume continues to increase. It was impacted a little bit by changes in wholesaler inventory levels. and Otrexup is still kind of tracking along at kind of in between the 2 quarter level, as you mentioned.

[Operator]

And your final question comes from the line of Thomas Flaten with Lake Street.

[Thomas Flaten, analyst]

I guess I didn't ask it explicitly, but are you guys being forced in the situations where you're price matching the lower prices with your INDOCIN accounts? Or how exactly is the pricing in the market impact you at kind of an account by account level?

[Daniel Peisert, executive]

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 than they're obviously going to take the business to 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 wholesale. On the account by account basis or if anyone is doing any GPO contracting or things like that, you can have some individual negotiations, but 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.

[Thomas Flaten, analyst]

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

[Daniel Peisert, executive]

The lowest. From a trade show, the lowest like 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 is what the general ballpark of where the generic is, the other numbers that we're hearing, we think are all coming from the compounded product.

[Operator]

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.

[Daniel Peisert, executive]

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 our stakeholders. Paul, Ajay and I speak for the collective 70 employees of Assertio. We are not here just for a quarter or two, We are 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.

[Operator]

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