Assertio Holdings Inc (ASRT) 2025 Q1 法說會逐字稿

Good day, ladies and gentlemen. Welcome to the Assertio Holdings first-quarter 2025 results conference call. Just a reminder that today's call is being recorded.

I would now like to hand things over to Mr. Matt Kreps. Please go ahead, sir.

Thank you, and good afternoon. Thank you all for joining us today to discuss Assertio's first-quarter 2025 financials. The news release covering our results 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 Brendan O'Grady, our Chief Executive Officer, and Ajay Patel, Chief Financial Officer. Brendan will open the remarks and provide an overview of the business, including an update on Assertio's long-term business strategy. After Brendan and Ajay will cover our financial results and guidance, Brendan will then provide some closing comments before we take questions from our covering research analysts.

Please note that 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 today's -- in this afternoon's press release as well as Assertio's filings with the SEC.

These and other risk factors are more fully described in the Risk Factors section and other sections of our annual report on Form 10-K and in our Form 10-Q filings. Our actual results may differ materially from those projected in the forward-looking statements. Assertio specifically disclaims any intent or obligation to update these forward-looking statements, except as required by law.

With that, I will now turn the call over to Brendan. Please go ahead.

Thank you, Matt, and thank you to everyone who has joined today's call. I'll begin today with a quick overview of our first quarter financial results, which are in line with the full-year 2025 net product sales and adjusted EBITDA expectations that were set forth during the March earnings call.

In the first quarter, net product sales came in slightly ahead of plan at $26 million, and we are tracking to our full year net product sales and adjusted EBITDA outlook. As I signaled in March, ROLVEDON results in the first quarter were impacted by sell-through of fourth quarter initial stocking activity that supported customer and volume expansion, which we expect to benefit us from Q2 onward. In addition, we are continuing to add new customers and have strengthened our payer coverage that started in February with Cigna and expect to further expand our payer coverage going into the second half of this year.

Overall, ROLVEDON demand remains strong and combined with our focused execution, we foresee net sales to continue increasing throughout the year. In addition, our revised Sympazan promotional strategy is proving effective with total Sympazan prescriptions in the first quarter up 6.5% year-over-year. This is a very positive trend that we expect will continue building in the quarters ahead.

Lastly, INDOCIN remained stable in the first quarter, achieving our expectation for net sales and contribution. These results, along with expected performance throughout 2025, are influenced by the substantial progress Assertio has achieved to date implementing the long-term business strategy that I put into place last year.

As I approach my one-year anniversary with Assertio, I think it's important to recognize the team's progress and address our expectations moving forward. As previously stated, our strategy includes three phases characterized as stabilization, transformation and growth.

Stabilization was successfully completed in 2024 and has adapted our organization to the changing operating environment. We strengthened our balance sheet, repositioned our portfolio to focus on ROLVEDON and Sympazan as core growth drivers, and rebalanced our talent and promotional resources.

These significant achievements paved the way for us to begin implementing our current phase, transformation. This phase is occurring throughout 2025 as we implement actions intended to catalyze a shift in future growth potential. I will cover this in more detail in just a minute.

Finally, the growth phase of our strategy is expected to start in 2026, during which time we intend to become a leading commercially-focused specialty pharma company that creates top-tier value over the long term.

Now coming back to the transformation phase of our strategy, we set forth the following priorities for 2025: first, reduce legal exposure; second, simplify our corporate structure and processes; third, prioritize investment in growth assets; fourth, divest noncore assets; and fifth, use the strength of our balance sheet to close a strategic transaction. These five transformation priorities are well underway with the goal of completing each by the end of this year, and I'm encouraged by our progress in just the first four months.

I'll address several notable achievements, and we'll start with reducing our legal exposure. Assertio has settled multiple prior legal matters, including the previously disclosed 2017 Department of Justice False Claims Act qui tam lawsuit, the last remaining Glumetza antitrust action and Spectrum's legacy Luo securities class action. It is important to note that we admit to no wrongdoing in any of these cases, but decided to settle rather than continue to litigate and incurring the cost to defend as well as the distraction to our business.

In addition, we obtained a dismissal of the company's Edwards securities class action pending court approval. Our overall progress in reducing our legal exposure improves our ability to optimize operating expenses by reducing legal costs and refocusing those resources back to the business.

As noted in our earnings release, we have also begun simplifying our corporate holding structure by transferring all of our assets in our Assertio Therapeutics subsidiary to ATIH Industries, LLC. At the closing of this transaction, Assertio Therapeutics held approximately $8.2 million in cash, a single-digit royalty in INDOCIN and certain legal liabilities, including those related to opioid litigation, which ATIH has assumed responsibility for managing and defending. As a result of this transaction, neither Assertio Holdings nor any of its current subsidiaries, remain named defendants in any opioid-related litigation.

As we move throughout the year, we will also progress our strategy to divest some noncore assets, which will further improve our ability to reallocate corporate resources to focus on growth and bolster our balance sheet to acquire or in-license new growth assets. Already, we have added new marketing support for ROLVEDON and rebalanced promotional efforts for Sympazan by augmenting our omnichannel activities with select in-person support for the largest markets and key high-decile prescribers. As a result, we are seeing improved efficiency and sales performance, as previously mentioned.

The actions I have just touched on allow Assertio to optimize operating expenses so that we can better invest in the future and advance our strategic activities as we move through the transformation and into the growth phase. I want to conclude my remarks by stating that Assertio's underlying business is strong and will be most successful by pivoting to a more sustained operating model, driven by not only cash flow assets, but by growth assets.

To be clear, our strategy is to focus on specialty pharma assets with the potential to grow over a sustained period of time within a commercially focused operating model. That is why we are implementing a long-term business strategy that we are confident can create sustained near-term growth and increase long-term value. I look forward to providing you with continued updates on our progress as we head through 2025.

I will now hand over to our CFO, Ajay Patel, who will walk us through the details of our first quarter performance.

Thanks, Brendan. Today, I'll walk through our financial results for the first quarter of 2025. My commentary will resume the use of year-over-year comparisons as we have now completed the stabilization phase that Brendan discussed regarding the 2023 Spectrum acquisition and INDOCIN generic competition, which made year-over-year comparisons difficult in 2024.

Q1 2025 product sales came in at $26 million compared to $31.9 million in the prior year quarter. ROLVEDON sales were $13.1 million, a decrease from $14.5 million in the prior year first quarter, driven by lower pricing, partially offset by higher volume.

As Brendan mentioned, the current year first quarter was impacted by fourth quarter stocking. INDOCIN net product sales were $5.5 million, down from $8.7 million in the prior year quarter due to the impacts of generic competition. The prior year first quarter was still in the early stages of the generic impact. Sympazan sales were $2.2 million compared to $2.6 million in the prior year period, impacted slightly by pricing and volume.

Reported gross margin increased to 70% from 65% a year ago. The prior year reported gross margin included ROLVEDON inventory step-up amortization. Excluding the impact of the inventory step-up, prior year gross margin was 78%. The year-over-year gross margin decline was driven by the impact of higher ROLVEDON volumes on cost of sales.

Turning to operating expenses. Reported SG&A expense was $22 million, up from $18.5 million in the prior year quarter, primarily driven by higher legal charges, including a net settlement charge of $2.8 million for the Luo shareholder matter.

R&D expense was $0.4 million, down from $0.7 million a year ago due to the completion of the same-day dosing trial at the end of 2024. Adjusted operating expenses, which excludes stock compensation, D&A, and nonrecurring restructuring and legal settlement charges, were $18.5 million compared to $17.3 million in the prior year period due to higher external litigation costs.

GAAP net income for the first quarter was a loss of $13.5 million compared to a loss of $4.5 million in the prior year. In addition to the impacts just discussed, GAAP net income was affected by higher intangible amortization expense due to a change in useful life at the end of 2024.

Adjusted EBITDA for the first quarter was $0.2 million compared to $7.4 million in the prior year quarter, primarily reflecting the impact of lower net sales and gross margin as discussed.

Turning to our balance sheet and cash flow statements. As of March 31, 2025, cash and investments totaled $87.3 million compared to $100.1 million as of December 31, 2024. Cash flow from operations during the first quarter was impacted by the timing of approximately $12 million of accounts receivable collected in early April.

At the end of April 2025, cash and investments stood at approximately $96.7 million. Debt at March 31, 2025, remains unchanged at $40 million, comprised of the company's 6.5% convertible notes with no maturities until September 2027.

With that, I will turn the call back to Brendan.

Thanks, Ajay. In the first quarter, the Assertio team delivered strong financial performance on track to the expectations that we set for 2025. We also demonstrated outstanding execution on the transformation phase of our business strategy with notable achievements that keep us on a path to realizing our goal of creating sustainable, near-term growth, and increased long-term value. I am confident that the strength of our underlying financials, ongoing business performance and business strategy will enable our success.

With that, let's go ahead and open the call for questions from our analysts.

(Operator Instructions)

Thomas Flaten, Lake Street.

Brendan, congrats on offloading the opioid litigation matters. Were there -- just out of curiosity on that, was there value in either direction on that? Did you guys pay them to take it? Did they pay you to accept it? Was there any value movement there?

Yeah. Just nominal value they paid us, Thomas.

Okay. And a quick one for Ajay. Ajay, you guys have some -- relative to the beginning of last year, your accrued rebates, returns, accrued liabilities are up. How should we think about you guys using cash to bring those balances back down again? Will that occur pretty evenly over the course of the year? Or how should we think about that?

Yeah, Thomas, thanks for the question. Yeh, I would think about that relatively evenly. As you know, the primary factor of that is ROLVEDON with its ASP-based pricing. So as the rebates increase for that, the payments typically occur in the subsequent quarter.

Got it. Understood. And just a final one for me, if I might. Any more thoughts on same-day dosing progress with NCCN? Any update on that?

Yeah, Thomas. So as we've discussed or said before, it's kind of a 12-month strategy as far as NCCN. So we've presented the results of the same-day dosing trial twice, once in December, once in, I think, March. We've approached a peer-reviewed journal for publication that we hope will be mid-summer. And once that's done, then we will approach NCCN about inclusion of the guidelines for 2026.

So everything is moving according to plan. Ultimately, we don't control whether we get in the NCCN for the guidelines or not, but we are executing the plan to get there.

Excellent. I'll hope back on the queue. Thank you.

Naz Rahman, Maxim Group.

Congrats on the progress. Just two questions. On ROLVEDON, I believe you previously spoke about expanding into the hospital setting away from the community setting. Could you provide some comments and details about how that's progressing thus far in 2025 and where you start -- or where you would expect to see an inflection point there?

Yeah. Hi, Naz, thanks for the question. I think if you think about ROLVEDON, today, most of our business is in the community oncology Medicare Part B space. To be successful in the hospital space, we really need to grow our commercial payer side. That will unlock a couple of things for us and then it will unlock more of the commercial channel for us, and then it will unlock hospitals as well.

So the next step in the strategy is really to build our payer coverage, which we've done with Cigna, as I mentioned in my opening comments, and hope to expand in the second half of this year and then further expand in 2026. As we do that, we'll be able to get more of the commercial clinic space business, as well as that will enable us to impact or penetrate hospitals to a greater degree.

Got it. Thank you. And my last question is just on guidance. So based on 1Q -- on the adjusted EBITDA guidance of $10 million to $19 million, why not adjust the band down? Or do you still think it's possible?

And what levers could you -- do you think will get you towards that $19 million? Why not adjust that band down from $10 million to something else to the 1Q results?

I think that there's still too many things going on that wouldn't make sense for us to adjust it down. We'll see how second quarter pans out, and we'll talk about it again in August. But at this point, I think the guidance ranges we put out there for both EBITDA and net sales, I think, we're tracking to within those guidance ranges. And we'll see how things go, but we'll update it again in August, if necessary.

Ram Selvaraju, H.C. Wainwright.

Just in furtherance of additional context regarding the ROLVEDON situation, can you give us a sense of what additional promotional or marketing strategies you expect to implement over the course of the remainder of this year to try to accelerate growth in ROLVEDON sales?

Sure. Hi, Ram, thanks for the question. A couple of things. I mean, first of all, there's still more market share we can get in our primary space, which is the Medicare Part B clinics. There's still some large groups out there that we hope to attract additional volume with an additional share. So that's one.

Second, I mentioned the payer piece. We've just begun to starting to pull that business through on the commercial side. So that's two.

We hope to expand that coverage in the second half of the year, which would be the third. And again, that will enable us to get some penetration into the hospital. So if you see that as kind of building throughout the year, we expect ROLVEDON to continue to grow in net sales and volume as we go through this year.

Can you talk about how you expect the overall genericization picture to evolve over the course of the remainder of 2025 with respect to INDOCIN? Are you expecting a substantial additional number of generic purveyors of INDOCIN between now and the end of 2025? If so, approximately how many? And what impact do you expect that to have even if only on a qualitative basis regarding the remaining INDOCIN revenue stream?

Yeah. Another good question. Thanks, Ram. I think our plan assumed two more generics for INDOCIN this year, one in the first half of the year, one in the second half of the year.

There was an approval back in February. We have not got any confirmation of launch yet. So I think we're still relatively tracking to plan. But you can think about if there's three on the market, you split the market by three. If there's four on the market, you split it by four.

So each time you lose volume and you lose price. So it will decline with the entrance of more generics. But I think I'm optimistic right now that we're tracking to our plan. I think we've got a pretty good handle on it. We'll optimize INDOCIN as much as we can as we go through the year.

And then lastly, you had mentioned on this in a couple of previous calls, the interest of the company in doing something on the strategic front to broaden potentially the commercial portfolio. Can you give us some additional context on that, if there's been any sort of evolution in your thinking, particularly as this pertains to the broader market environment, changes that you're seeing within that. And also the possibility of identifying opportunities that are directly synergistic with your existing commercial assets?

Yeah. I mean we have numerous ongoing conversations, all very positive conversations going in the right direction. And I'm very optimistic that we will get something done in 2025 that will certainly add to our business and position us for that growth phase in 2026. I obviously can't be more specific than that, but I'm very encouraged by the conversations that we currently have going on.

But just for clarification purposes, as of right now, your forecast, your outlook for 2025 is not contingent upon any such business development activity being successfully concluded. Is that correct?

That is correct. Our outlook for 2025 includes only our current portfolio.

Scott Henry, Alliance Global Partners.

I guess, first, with regard to ROLVEDON, you do mention pricing pressure. Could you talk about the pricing, how it is year-over-year and sequentially and your expectations going forward?

Yeah. Hi, Scott, I mean, it is a quarter-to-quarter type of strategy. So ASP does erode over time. And some quarters is a bigger impact than others. It's a very competitive marketplace as we play in this Neulasta biosimilar long-acting G-CSF space. And there could be new entrants that enter as we go through this year that could also have an impact.

So we're -- I think we're doing a very good job of maintaining and managing our ASP. I think the way that we think about the business and the way we execute and contract the business is smart, which I think is why our ASP has been slower to erode maybe than others. And we continue to build volume and gain new customers.

And that's part of the step down from Q4 to Q1 was we brought in some new customers in Q4 that we're going to pull through in Q1. So we wanted that inventory there, and we pulled that through in Q1. So you'll start to see that grow as we go into Q2 and beyond.

Okay. Thank you for that color. And then with regards to SG&A, I believe you said that the base SG&A is around $18.5 million quarterly. I guess the question is, did I hear that correct?

And as well, what would you expect for the legal wind down, particularly given that you've had this divestment, should that start to be declined materially in the coming quarters? Or how long should some of that other litigation take?

Yeah. No, thanks for the question, Scott. You're right. So the base adjusted OpEx for the first quarter was $18.5 million.

Now in the first quarter, we were burdened -- we typically have kind of two components of litigation exposure: legacy matters and shareholder matters. As Brendan kind of alluded to in his comments, right, the legacy matters for the most part have been mitigated now with the divestment of Assertio Therapeutics.

We are expecting kind of on an annualized front that to benefit us in the neighborhood of $2 million to $3 million annually. And then from a shareholder litigation, as we continue to resolve, settle and exit those cases, the ongoing burden does decrease over time.

Okay. Final question, just for clarity, what is assets exactly did you divest into the AITH (sic - "ATIH ") entity? And was there any material EBITDA impact from those assets?

There is just a single-digit royalty on INDOCIN that we divested with the therapeutics divestiture in ATIH as well as some cash.

Okay. All right. So none of the other products went with it, none of the smaller ones?

No.

Okay. And if I may, and I guess it's -- I don't want to ask you a legal question, but I think I'm going to. If you divest some of your legal responsibilities to this asset, what is the risk that they could still come after the parent company that you can't, in fact, completely divest that liability?

Well, I mean, if you think about it, the way that we got the liability was through M&A. And so this is no different. We transferred this legal entity to a third party that is going to maintain and run this business and manage it accordingly. So while there's always a risk, I think the risk is very, very low.

(Operator Instructions)

Jim Sidoti, Sidoti & Company.

In addition to all the internal changes there, you're dealing with some external changes as well. Can you comment on what impact do you think there could be from either the tariffs or the executive order regarding drug pricing or the proposed changes to Medicaid?

Yeah. I mean -- so the tariffs is -- who knows, right? That's a daily up and down. We've got a significant -- I mean, probably the thing we would be most exposed on with tariffs would be drug substance on ROLVEDON, but we've got a significant inventory here in the US. So we don't expect any short-term impact. And by the time there's an impact, hopefully, that situation will be worked out.

With regards to drug pricing, we do not sell any products outside of the US with the exception of Cambia that we sell in Canada and Cambia is probably more expensive in Canada, the fact that it's not generic and it's generic here. So we'll see.

There needs to be a lot more details on drug pricing. It's going to take a while for the details to come out as to how that's actually going to play out. But at least right now, we don't see any real risk on either one of those two things.

Okay. And I just want to be clear, post the divestiture, are you maintaining your revenue guidance of $108 million to $123 million?

We are.

And at this time, there are no further questions. Everyone, that does conclude today's Assertio Holdings first quarter conference. We would like to thank you all for your participation. You may now disconnect.