Assertio Holdings Inc

NASDAQ:ASRT

Earnings Call Transcript 2024-Q1

[Operator]

Good afternoon, and welcome to Assertio Holdings First Quarter 2024 Financial Results Call.

[Operator Instructions]

I would now like to turn the call over to Matt Kreps, Investor Relations for the company. Please go ahead.

[Matthew Kreps]

Thank you. Good afternoon, and thank you, everyone, for joining us today to discuss Assertio's first quarter 2024 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 press release and tables in conjunction with today's discussion.

With me today are Heather Mason, Interim CEO, Ajay Patel, CFO; and Paul Schwichtenberg, CCO.

In just a moment, Heather will open the remarks and provide an overview of the business then Ajay will cover our financial results and guidance, following with Paul with an update on our commercial strategies. After that, we will take questions from our covering research analysts.

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. Assertio specifically disclaims any intent or obligation to update these forward-looking statements, except as required by law.

And with that, I will now turn the call over to Heather. Please go ahead.

[Heather Mason, executive]

Thank you, Matt. Welcome, everyone, and thank you for joining us today. Since stepping into the interim CEO role in January, I am encouraged by the progress we are making at business and I am deeply grateful to all of my colleagues at Assertio, who continue to work tirelessly for our patients and clinicians and to drive long-term value for our shareholders. We are off to a good start this year.

Our first quarter is tracking with our full year guidance, calling for sales of $110 million to $125 million and EBITDA of $20 million to $30 million. There is demonstrated execution across several fronts. Rolvedon Q1 sales are up 32% quarter-over-quarter. This is Rolvedon's fifth consecutive quarter of demand growth, a critical success measure in the intensely competitive long-acting GCSF category. Additionally, we completed enrollment of Rolvedon same-day dosing trial early in Q2. We expect the data readout before year-end and the results could lead to an opportunity for product differentiation through medical society guidelines. Paul will expand on Rolvedon performance and further growth plans. Indocin still has one generic competitor and our share of the overall molecule is approximately 50%. And we are working to maintain our volume at a competitive price while anticipating a second generic.

We have successfully rightsized our organization, cut operating expenses and have ensured we have the right team in place to deliver results. Additionally, we generated $7.5 million in cash in the quarter important as we look to add accretive cash-generating assets that fit our lean commercial model. I also want to be clear, we are not satisfied with where our stock price is. But we believe that driving sustainable long-term shareholder value is best achieved by growing sales and profitability by diversifying our revenue streams and by generating more predictable cash flows. These are the tasks we are focused on every day.

Finally, our CEO search is on track. The Board is committed to finding the best candidate with a balance of commercial, financial and business development skills. We've identified strong candidates, and I look forward to announcing our next CEO soon. And with that, I'll pass the call over to Ajay to cover financials.

[Ajay Patel, executive]

Thanks, Heather. Today, I would like to cover our financial results for the first quarter of 2024. Before I begin, I want to note that my commentary will focus on sequential comparisons to fourth quarter 2023, given the acquisition of Spectrum and the generic competition of Indocin that occurred in the prior year fourth quarter.

Rolvedon is now our lead asset and brings with it associated changes in margin and operating cost structure. For the first quarter of 2024, our total sales were $31.9 million, down slightly from $32.5 million in the fourth quarter. Rolvedon sales were $14.5 million and achieved 32% growth compared to $11 million in the fourth quarter, primarily due to volume. Indocin sales were $8.7 million compared to $10.8 million in the fourth quarter. As expected, the decline was due to the impact on volume and pricing from generic competition. Excluding the impact of inventory step-up, gross margin in the first quarter was 78% compared to 79% in the fourth quarter. Inventory step-up was materially complete at the end of the first quarter.

Turning to operating expenses. SG&A expense were $18.5 million in the first quarter, down 23% from $24 million in the fourth quarter. Excluding stock compensation, adjusted OpEx was [ $17.3 million ] in the first quarter and reflects the benefits from actions the company has taken to reduce and align expenses to its current asset portfolio.

GAAP net income for the first quarter was a loss of $4.5 million, down from a loss of $57.4 million in the fourth quarter. Both quarters included the impact of noncash adjustments, making them difficult to compare. However, adjusted EBITDA is a good indicator of the operating performance of the core business. Q1 adjusted EBITDA was a positive $7.4 million increased from Q4 adjusted EBITDA of $4.5 million due to the sales and OpEx favorability just noted. Please refer to our press release for a detailed reconciliation of our adjusted EBITDA results.

Crossing over to cash flows and our balance sheet, we generated $7.5 million in cash flow from operations in the first quarter. As we have previously noted, quarterly operating cash flows will fluctuate due to the timing of working capital, royalties and interest payments. Additionally, similar to the P&L results, as we shift from Indocin to Rolvedon, there is a pronounced impact to operating cash flows, which will take a few quarters to be realized. Rolvedon carries a higher gross revenue profile than Indocin, which results in higher upfront cash collections. But at the same time, Rolvedon also has a higher gross to net rate, which results in higher rebate settlements down the road.

Cash at the end of the first quarter was $80.7 million and debt was $40 million. And looking at our cash deployment opportunities, as Heather stated, we are focused on investments that can grow sales and profitability in a manner that increases durability and predictability of the business. We are pleased with Q1 results, but also recognize that stabilization and growth in the business is a multistage process that requires focus on execution and ensuring appropriate capital access is maintained based on internal liquidity as well as external availability. We are maintaining our previously announced guidance for 2024. We expect net product sales in a range of $110 million to $125 million. We anticipate adjusted EBITDA in a range of $20 million to $30 million.

I'll now turn the call over to Paul to give commercial update.

[Paul Schwichtenberg, executive]

Thank you, Ajay. Over the past few years, we have built a diversified cash flow generating asset portfolio focused on commercial assets aligned to our low-cost, efficient sales and marketing approach. Last fall, we saw two major changes around our lead assets, Indocin and Rolvedon, which occurred in short order but we continue to maintain our commitment to generating cash flow and new opportunities within our existing product set. I know that many of you are very focused on our commercial plans and in particular, our growth efforts around Rolvedon. We reported a strong start to 2024 as Rolvedon net sales increased 32% over the prior quarter, including a 24% sequential increase in unit demand. Q1 2024 reflected our fifth sequential quarter of demand growth and the largest quarterly percentage growth since its first full quarter after launch. ASP erosion has been in line with expectations holding to low single digits, and we currently have the second highest ASP in the class.

We believe our market share in the Medicare Part B market we currently serve is approximately 34%. Our success to date has been driven by excellent performance in the clinic space due to our dedicated contracting and commercial access capabilities, even with strong competition from the biosimilars. Our strategy is to continue to drive growth in this important segment, which is about 1/3 of the total market through both further market penetration into new sites as well as volume gains at existing clinics.

We are leveraging our commercial sales team as well as digital promotion efforts to achieve further market penetration. We are also looking to expand into new hospital customers as we continually work towards building Rolvedon into greater than a $100 million asset in the years ahead.

Moving to Indocin. Q1 performance was in line with our expectations as we continue to adapt to a competitive market. Our efforts to date have resulted in approximately a 50% volume share in the market, although the generic competitor has priced aggressively. We remain focused on protecting our share and maximizing the value of Indocin as a cash flow generating asset.

Turning to Sympazan. Q1 performance was in line with our expectations. While the active ingredient is widely known and well understood, Sympazan is particularly appealing with certain targeted hard-to-control patients due to its delivery mechanism. This is in part why it's a good fit to Assertio's platform and why we see additional opportunity in this asset. We are making an incremental strategic investment in Sympazan to change our marketing mix and raise awareness with the goal to drive incremental volume growth starting in 2025.

Lastly, I'd like to commend and thank our entire commercial team as they continue to execute well and deliver results. With that, I'll turn the call back to the operator for Q&A from our covering research analysts.

[Operator]

[Operator Instructions]

The first question comes from the line of Jim Sidoti from Sidoti & Co.

[James Sidoti, analyst]

You talked about the completion of the enrollment for the trial for same-day dosing. Can you just go on the time line? What's the next step for that? And what do you think the potential for that is in terms of of additional revenue if you should get that approval.

[Paul Schwichtenberg, executive]

Sure. Jim, this is Paul here. I'll address that question. So the last patient has been enrolled as we said earlier, we are in the data analysis phase right now, and we expect to publish the -- sorry, present the data in Q4. As a reminder, this will not be a label change, but this will just be new data that will be available. We don't have any impact planned in 2024, which was consistent with our guidance and I think any future impact is going to be determined.

[James Sidoti, analyst]

Okay. And as you look at the new products to bring in the portfolio, how critical is it that those products are able to be distributed to your virtual network? Is that a must or are you considering products that would go through the more traditional in-person sales force?

[Heather Mason, executive]

We are open, Jim, to the go-to-market model in terms of direct sales versus more digital interaction.

[James Sidoti, analyst]

And in terms of product categories, I mean, are you focused more on the pain management and cancer treatment drugs? Or are you open to other types of drugs as well?

[Heather Mason, executive]

Although it be great, Jim, to have products in, for example, the oncolytic supportive care area. That's a small set of products. So we're looking more broadly than that. But we certainly would be thrilled to find something that even better leverages our current set of assets that are talking to doctors right now.

[James Sidoti, analyst]

All right. And then the last one for me. What are your options to finance the deal? Are you considering debt? Or would you prefer to do an all-equity deal or have you some the cash off the balance sheet?

[Ajay Patel, executive]

Jim, this is Ajay. Yes, I think it's all going to be predicated on the type of deal and the type of assets that's being targeted. We're going to look at the cost of capital from all 3 of those venues, right? In the current state of things, the cash utilization is most optimal, but we'll be evaluating and balancing it to ensure the cost of capital utilization is appropriate.

[Operator]

The next question comes from the line of Thomas Flaten from Lake Street Capital Markets.

[Thomas Flaten, analyst]

Paul, maybe I could just key off the last thing you said about Sympazan that you're making a strategic investment. I was wondering if you could clarify maybe a little bit more what that might look like. And then you also said with plans for growth for 2025, is the implication there that there won't be any growth in 2024?

[Paul Schwichtenberg, executive]

I think the answer to the last part of your question is no, not necessarily. I think we're looking at kind of the continued growth that we've seen with Sympazan. Maybe it's a low single-digit level. However, as I mentioned, we do believe that there is some opportunity in this market to get our message out there. And what we're looking to do is really shift around our marketing mix and where we're spending our dollars and put it in different places that we think will get us better access to physicians and patients that will drive volume going forward. Obviously, we need a little time to implement what we're trying to do, and that's why we're looking at the impact not really happening until 2025.

[Thomas Flaten, analyst]

Got it. Yes. Heather, you mentioned the CEO search. It sounded like there was -- you were down to a relatively small number of candidates. Can you maybe give us some sense of who they are, where they've been, what kind of experience they have just in a very generic manner?

[Heather Mason, executive]

I'm not prepared to discuss that, Thomas. But rest assured, we are -- we have set a very clear list of criteria from both an experience perspective and both functionally and in the marketplace and have been pleased with the caliber of talent we've been able to talk to. And when we get ready to announce them, Thomas, then we'll talk about the answers to your questions. The bar is high and we feel good.

[Thomas Flaten, analyst]

Got it. Ajay, you mentioned that the inventory step-up was going to be -- or was substantially completed by the end of the first quarter. Can you give us a sense of where you think margins can be given the new product mix, gross margins that is?

[Ajay Patel, executive]

Yes. I think we would say we're anticipating a slight continued decrease in our margins from where they were, as I kind of said, up the 78% in Q1 as Indocin continues to decline, the margin start elevating towards Rolvedon. I think we're targeting in the mid-70s is a good target for us to maintain.

[Thomas Flaten, analyst]

Got it. Got it. And then just one final one maybe for Paul. For the clinics where you are having particular success from a volume perspective, is there something common among those clinics? Are they -- does it have to be -- or is it perhaps coverage? Is there something that those doctors see in Rolvedon that they might not see in the other products, help if you could maybe just kind of characterize those success clinics a little bit.

[Paul Schwichtenberg, executive]

Well, I think the short answer is we're having success across a broad number of clinics across the country. And where we're having success is where we've got good contracts in place and also there's a lot of coverage in Medicare Part B, which is our primary space that we're playing in right now.

[Operator]

As there are no further questions in the queue at this time, this concludes our Q&A session. I would like to turn the call over back to Heather Mason for closing remarks.

[Heather Mason, executive]

Thank you, and I appreciate everyone who's joined us today. And I hope that today's call has given clarity that we're doing what we said we were going to do. Our intent is to grow Rolvedon, manage Indocin, ensure rightsized operating expenses, maintain cash generation, be active on the business development front, close in on a CEO candidate. And as we keep moving forward, we'll apprise you of any additional developments. If you'd like to arrange a call with management, please contact Matt Kreps directly, and we'll be happy to schedule a time. Once again, thank you for joining.

[Operator]

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.