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spk06: to Matt Krebs, investor of relations for the company. Please go ahead.
spk02: Thank you. Good afternoon, and thank you, everyone, for joining us today to discuss Asardio'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.asardiotx.com. I would encourage you to review the press release and tables in conjunction with today's discussions. With me today are Heather Mason, interim CEO, A.J. Patel, CFO, and Paul Schrechtenberg, CCO. In just a moment, Heather will open the remarks and provide an overview of the business. Then A.J. will cover our financial results and guidance, followed by 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 performances. 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 Sardio'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. Sardio specifically disclaims any intent or obligation to update these forward-looking statements except as required by law. And with that, I'll now turn the call over to Heather.
spk05: Please go ahead. Thank you, Matt. Welcome, everyone, and thank you for joining us today. Since stepping into the interim CEO role in January, I'm encouraged by the progress we are making as a 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 to $125 million and EBITDA of $20 to $30 million. There is demonstrated execution across several fronts. Rolvidon Q1 sales are up 32% quarter over quarter. This is Rolvidon's fifth consecutive quarter of demand growth. a critical success measure in the intensely competitive long-acting GCSF category. Additionally, we completed enrollment of Rolvidan's same-day dosing trial early in Q2. We expect a data readout before year end, and the results could lead to an opportunity for product differentiation through medical society guidelines. Paul will expand on Rolvidon performance and further growth plans. Indicyn still has one generic competitor, and our share of the overall molecule is approximately 50%. We are working to maintain our volume at a competitive price while anticipating a second generic. We have successfully right-sized 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 candidates 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 AJ to cover financials.
spk04: 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 Indison that occurred in the prior year third quarter. Bovadon 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, Rovedon sales were $14.5 million and achieved 32% growth compared to $11 million in the fourth quarter, primarily due to volume. Induson 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 was $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. Gap 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 non-cash 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 Indus and to Rovadon, there is a pronounced impact to operating cash flows which will take a few quarters to be realized. Rovadon carries a higher gross revenue profile than Indison, which results in higher upfront cash collections. But at the same time, Rovadon 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. In 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 multi-stage 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 to $30 million. I'll now turn the call over to Paul to give commercial update.
spk00: 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, Induson and Robodon, 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 Robodon. We reported a strong start to 2024 as Robodon 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 the low single digits, and we currently have the second highest ASP in the class. We believe our market share in the clinic 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 one-third 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 toward building Rovadon into greater than a $100 million asset in the years ahead. Moving to Indicent, 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 of the market, although the generic competitor has priced aggressively. We remain focused on protecting our share and maximizing the value of Indicent as a cash flow generating asset. Turning to Simpizan, Q1 performance was in line with our expectations. While the active ingredient is widely known and well understood, Simpizan 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 Simpizan 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.
spk06: Thank you. We will now begin our question and answer session. At this time, if you would like to ask a question, please press star followed by the number one on your telephone keypad. If you would like to withdraw your question, simply press star again. We'll pause for just a moment to compile the Q&A roster. The first question comes from the line of Jim Sidoti from Sidoti & Co. Please go ahead.
spk01: All right. Good afternoon. Thanks for taking the questions. You talked about the completion of the enrollment for the trial for same-day dosing. Can you just go over now the timeline? What's the next step for that? And what do you think the potential for that is in terms of additional revenue, if you should get that approval?
spk00: Sure. Hi, 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 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 is consistent with our guidance, and I think any future impact is going to be determined. Okay.
spk01: As you look at the new products to bring into 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 Salesforce?
spk05: We are open, Jim, to the go-to-market model in terms of direct sales versus more digital interaction.
spk01: Right. 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?
spk05: Although it'd 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, you know, would be thrilled to find something that even better leverages our current set of assets that are talking to doctors right now.
spk01: All right. And then the last one for me, you know, what are your options to finance the deal? Are you considering
spk04: uh debt or would you prefer to do an all equity deal or are you sending the cash off the balance sheet hey jim this is aj yeah i think well 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 three of those venues right um in the current state of things um the cash utilization is most optimal But we'll be evaluating and balancing it to ensure the cost of capital utilization is appropriate.
spk01: All right. Thank you.
spk07: Thank you.
spk06: The next question comes from the line of Thomas Flayton from Lake Street Capital Markets. Please go ahead.
spk03: Good afternoon. I appreciate you guys taking the questions. Paul, maybe I could just key off the last thing you said about Simpazan, that you're making a strategic investment. I was wondering if you could clarify that. 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?
spk00: I think the answer to the last part of your question is no, not necessarily. I think we're looking at, you know, kind of the continued growth that we've seen with Simpazan, 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, you know, why we're looking at the impact not really happening until 2025. Got it. Right.
spk03: Yep. Heather, you mentioned the CEO search. It sounded like 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?
spk05: I'm not prepared to discuss that, Thomas. But to rest assured, we have set a very clear list of criteria from both experience perspective 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. But the bar is high and we feel good.
spk03: Got it. AJ, 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?
spk04: Yeah, I think we would say we're anticipating a slight continued decrease in our margins from where they were, as I kind of said, at the 78% in Q1 as Indusim continues to decline. The margins start elevating towards Rovidon. I think we're targeting in the mid-70s is a good target for us to maintain.
spk03: 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? Does it have to be, or is it perhaps... coverage? Is there something that those doctors see in Rolvidon that they might not see in the other products? Help if you could maybe just kind of characterize those success clinics a little bit.
spk00: Well, I think the short answer is we're having success across a broad number of clinics across the country. And, you know, where we're having success is where we've got good contracts in place. And also they're There's a lot of coverage in Medicare Part B, which is our primary space that we're playing in right now.
spk03: Got it. Appreciate it. Thanks, everyone.
spk07: Thank you.
spk06: As there are no further questions at the queue this time, this concludes our Q&A session. I would like to turn the call over back to Heather Mason for closing remarks.
spk05: 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 Rovidon, manage Indison, ensure right-sized operating expenses, maintain cash generation, be active on the business development front, close in on CEO candidates, 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 Krebs directly, and we'll be happy to schedule a time. Once again, thank you for joining.
spk06: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect. Ladies and gentlemen, this concludes today's conference call. Thank you for your participation.
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