Q2 2025 Assertio Holdings Inc Earnings Call

Speaker #1: Hello, and welcome to the Assertio Holdings second quarter 2025 results conference call. All lines have been placed on mute to prevent any background noise.

Speaker #1: After the speaker's remarks, there will be a question and answer session. If you would like to ask a question at this time, please press star 1 on your telephone keypad.

Speaker #1: I would now like to turn the conference over to Matthew Kreps, Investor Relations. You may begin.

Speaker #3: Thank you. Good afternoon, and thank you all for joining us today to discuss Assertio's second quarter 2025 financial results and business update. The news release covering our results for this period is now available on the Investor page of our website at investor.assertio.tx.com.

Speaker #3: I would ourage you to review the release and tables in conjunction with today's discussion. With me today are Brendan OGrady, our Chief Executive Officer, and Ajay Patel, our Chief Financial Officer.

Speaker #3: Brendan open the remarks and provide an overview of the business, including an update on Assertio's long-term business strategy. After Brendan, Ajay will cover our financial results and guidance.

Speaker #3: Brendan will then provide some closing comments before we take questions from our covering and research analysts. Please note that during this call, management will make projections and other forward-looking statements regarding our future performance.

Speaker #3: 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.

Speaker #3: These and other risks are more fully described in the risk factor section and other sections of our annual report on Form 10-K and in our Form 10-Q filings.

Speaker #3: 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.

Speaker #3: With that, I will now turn the call over to Brendan. Please go ahead.

Speaker #4: Thank you, Matt. And thank you to everyone who has joined today's call. I'll begin today with a brief overview of our second quarter financial results, which showcase both execution against the transformation phase priorities I have laid out as part of our long-term business strategy and our ability to focus the business in ways that improve operating performance for our investors.

Speaker #4: We have also updated our full-year outlook accordingly, slightly reducing the top end of our revenue range to account for our decision to stop the commercialization of Otrexate.

Speaker #4: But more importantly, raising the lower end of our adjusted EBITDA outlook has a positive impact on raising profitability. To give a little further into the details, second quarter net product sales came in on plan at $28.8 million.

Speaker #4: These sales results reflect the highest rollover on provider demand volume since launch benefiting from an expanding provider base and continued growth in SimpliSam prescriptions from both existing and an increasing number of new prescribers.

Speaker #4: This is in response to our decision last year to augment our omnichannel marketing with in-person sales in key markets. Overall, demand for both rollover on in SimpliSam remains strong and is growing.

Speaker #4: We continue to execute diligently on our plans to drive further growth on each product. Indocin and our other core non-core assets performed in line with expectations for net sales and contribution.

Speaker #4: These results underpin the three-part business strategy I introduced during our year-end call in March, and further detailed during the May earnings call. To briefly recap, the three phases are defined as stabilization, transformation, and growth, and are intended to create substantial near-term growth and increasing long-term value.

Speaker #4: Stabilization was successfully completed in 2024 and is adapted to our organization to the changing operating environment and reprioritization of assets. That stage included repositioning our portfolio to focus rollover on in SimpliSam as core growth drivers, leading to the benefits seen on both of these products year to date.

Speaker #4: With an expectation of more to come. I have characterized 2025 as the transformation phase. Focusing on actions intended to catalyze a shift in future growth potential and that's obviously where we are today.

Speaker #4: Continued successful execution of our transformation objectives will launch the growth phase of our strategy 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.

Speaker #4: Now, I'd like to provide you a brief update on our transformation progress. In the second quarter, we advanced each of our five core objectives and expect all to be complete or nearly complete by the end of the year.

Speaker #4: As a reminder, these include one, reducing our legal exposure; two, simplify our corporate structure and processes; three, prioritize Assertio's investment and growth assets; four, divest non-core assets where it makes sense; and five, use the strength of our balance sheet to close a strategic transaction.

Speaker #4: Starting with reducing our legal exposure, we have now settled or closed multiple prior legal matters helping to remove both ongoing operating costs and future uncertainty from business.

Speaker #4: Resolutions to date include the 2017 key TAM lawsuit, the last remaining Glumetza antitrust action, and Spectrum's legacy Luao security class action pending court approval.

Speaker #4: We have not admitted to any wrongdoing in any of these cases; rather, the decision to settle reduces both ongoing legal costs and distraction from our core business.

Speaker #4: We also obtained a dismissal of the company's Edwards security class action suit. With these matters now closed, we can refocus funds previously allocated to legal costs into building our core business.

Speaker #4: We also began simplifying our porate holding structure to reduce costs and complexity in our business. One of the key actions completed in the second quarter was the transfer of all our interests in our subsidiary Assertio's therapeutics to a third-party ATIH Industries LLC.

Speaker #4: As of today, Assertio Holdings, nor any of its subsidiaries, are named defendants in any opioid-related litigation. Also, as part of our corporate restructure, we are consolidating products from previously acquired operating subsidiaries to further consolidate our commercial footprint and further reduce operating expenses.

Speaker #4: As part of this process, we have initiated a labeler code change for rollover on. This may result in net sales fluctuations over the next three quarters due to certain timing aspects, but we expect 2025 company net sales to be within our guidance range.

Speaker #4: Further, we expect to fully support rollover on demand while maintaining price stability and predictability for our ustomers during this change. Focusing on our progress, prioritizing investments in rollover on in SimpliSam, we've now finalized our third national agreement for rollover on with the GPO of a leading national payer.

Speaker #4: This milestone reflects continued momentum in ur market access strategy. We are currently working with the GPO to engage their national member organizations in discussions to broaden commercial formulary positioning for our product.

Speaker #4: We believe this agreement represents a meaningful opportunity to broaden access and support long-term growth for one of our two core growth assets. In addition, we're eing sustained momentum across strategic market segments as organizations explore forward-looking approaches to care delivery.

Speaker #4: This latest agreement further substantiates a growing trend of engagement, underscoring our conviction of rollover on's long-term potential. I look forward to providing further updates at a later date.

Speaker #4: Regarding divesting non-core assets, as mentioned, we decided to stop commercializing Otrexate and are exploring various options for this product going forward. This is intended to free up additional resources to reallocate to our growth assets, bolster our ability to acquire or in-license new growth assets, and increase our profitability.

Speaker #4: We are looking at the balance of our portfolio with a similar focus on improving cost efficiency and sales performance. These actions are driven by strategic decisions to thoughtfully address near-term costs and disruptions for the benefit of our long-term business performance.

Speaker #4: This quarter's progress and our dated outlook demonstrate a sharpened focus to create greater efficiency, redirect resources, and ultimately improve profitability as we move through the transformation and into the growth phase.

Speaker #4: We believe that Assertio has reached an inflection point and will be most successful by pivoting to a focus on specialty pharma assets with the potential to grow over a sustained period, with a commercially focused operating model.

Speaker #4: And that is where our fifth transformation priority is focused: expanding and diversifying our portfolio with new growth assets, whether acquired, licensed, or via some other form of transaction.

Speaker #4: We remain active in that area, but also focused on securing right transaction at the right price which are balance sheet improvement, continues to support with greater flexibility.

Speaker #4: I'll conclude my remarks today building on what I said last quarter. Assertio's underlying business is sound. We have an experienced team that is executing very well and our balance sheet fueled by more than $98 million in cash and investments at the end of the second quarter is solid.

Speaker #4: I am confident that our long-term business strategy is leading us in the right direction toward our goal of creating sustainable near-term growth and increased long-term value.

Speaker #4: I look forward to providing you with additional updates on our progress as we head through the second half of this year. I will now hand it over to our CFO, Ajay Patel, who will walk us through the details of our second quarter performance.

Speaker #4: Ajay?

Speaker #5: Thanks, Brendan. Today, I'll walk through our financial results for the second quarter of 2025. As a reminder, starting last quarter, we have resumed the use of year-over-year comparisons reflecting the completion of the stabilization phase that Brendan discussed for 2024.

Speaker #5: Q2 2025 product sales came in at 28.8 million dollars compared to 30.7 million dollars in the prior year quarter. Rollover on sales were 16.1 million dollars up from 15.1 million dollars in the prior year quarter.

Speaker #5: Driven by higher volume and favorability from the returns reserve adjustment, partially offset by lower pricing. The returns reserve adjustment was $5.4 million and was previously established in connection with the Spectrum merger for specific channel inventory.

Speaker #5: Due to continued growth in demand and closure of the returns window, we no longer need to maintain the specific reserve. SimpliSam sales were 3.2 million dollars.

Speaker #5: Up from $2.7 million in the prior year period, reflecting higher volume and a favorable payer mix. Indocin sales were $3 million, down from $6.9 million in the prior year quarter.

Speaker #5: Due to the expected generic competition on volume and price, the prior year's second quarter was still in the early stages of the generic impact. Turning to operating expenses, reported SG&A expense was $17 million, down from $18.4 million in the prior year quarter.

Speaker #5: Reflecting among other items, a one-time 2.4 million dollar benefit from the recognition of employee retention tax credits. R&D expense was 0.4 million dollars down from 0.8 million dollars a year ago.

Speaker #5: Due to the completion of the same-day dosing trial at the end of 2024. Excluding stock compensation, DNA, and one-time items of ERC benefit, legal settlements, and costs related to divestment of Assertio Therapeutics, and decommercialization of Otrexate, adjusted operating expenses were 15.4 million dollars in the second quarter, versus 19.7 million dollars a year ago.

Speaker #5: Reflecting our efforts to drive operating cost efficiencies, as well as timing of certain annual spend. Gap net income for the second quarter was a loss 16.4 million dollars compared to a loss of 3.7 million dollars in the prior year.

Speaker #5: The change in net loss reflects one-time charges, including $9.2 million related to the divestiture of Assertio Therapeutics and $3.8 million pertaining to the decision to cease Otrexate commercialization.

Speaker #5: Which were partially offset by a 2.4 million dollar benefit from the recognition of employee retention tax credits. Adjusted EBITDA for the second quarter was 5.6 million dollars compared to 3.1 million dollars in the prior year quarter.

Speaker #5: Turning to our ance sheet and cash flow statements. As of June 30, 2025, cash, cash equivalents, and short-term investments totaled 98.2 million dollars. An increase from 87.3 million dollars as of March 31, 2025.

Speaker #5: The increase was driven by positive operating cash flows as a result of overall performance and favorable working capital. Partially offset by investing activity of 8.2 million dollars transferred in connection with the divestment of Assertio Therapeutics.

Speaker #5: Debt remains unchanged at 40 million dollars comprised of the company's 6.5% convertible notes with no maturities until September 2027. As Brendan mentioned, we are narrowing our guidance ranges for net product sales and adjusted EBITDA to reflect first half performance, the decision to cease commercialization of Otrexate, and improved operational efficiencies.

Speaker #5: The revised annual guidance range has been updated for net product sales to 108 million dollars, to 118 million dollars, and for adjusted EBITDA from 11 million dollars to 19 million dollars.

Speaker #5: I'll now hand the call back to Brendan.

Speaker #4: Thank you, Ajay. The Assertio team delivered a second quarter of strong financial performance and remains on track to meet our ectations for 2025. We also demonstrated the potential value of our transformation initiatives in creating both short-term and long-term value for our stockholders.

Speaker #4: We remain fully focused on executing the remaining transformation initiatives planned for this year, I am confident that our ongoing business performance and execution of our business strategy will enable our success, and with that, let's go ahead and open the call for questions from our analysts.

Speaker #2: Thank ou. Again, if you would like to ask a question, it is star 1 on your telephone keypad. If you would like withdraw your question, simply press star 1 again.

Speaker #2: Your first question comes from the line of Thomas Flatten with Lake Street. Your line is open.

Speaker #6: Hey, good noon. I appreciate you guys taking the questions. Just starting off, so I'm trying to understand the kind of quote-unquote true rollover on sales in the quarter.

Speaker #6: I mean, if I take the number minus the reserve, it's $10.7. Is that how I should be looking at it? I'm trying to... can you help me better understand that?

Speaker #7: Yeah, that's the correct number, Thomas.

Speaker #6: So, if I'm, if I heard you correctly, Brendan, in the prepared remarks, it was the highest demand from providers. But then, you know, can you give us a sense of the volume price shift there so we can kind of understand what's going on—demand versus pricing?

Speaker #7: Yeah, I, I, I will get into too much in pricing. That's something we don't really divulge, but I will just give you a little bit of a flavor, right?

Speaker #7: So, there's, X factory sales that go into the wholesalers, and then there's demand that goes from the wholesalers into the clinics. So, as I mentioned, we had a, a rather high, in fact, we grew demand, by almost 20% from Q1 to Q2.

Speaker #7: So, demand going into the clinics, which is ultimately which, is what patients utilize, is very strong. And, we were, a little, lower on, sales into the wholesalers, which sets us up really in a good position for a ong execution in the second half of the year.

Speaker #7: So, I wouldn't think about the years taking 13.1 and 10.4, and then doubling it. I think we're in a very good position to achieve what we need to in the second half of the year with rollover on.

Speaker #7: Kind of balancing wholesaler and, clinic demand.

Speaker #6: Excellent. I, I, I, I appreciate that, that color. and then with respect to, potential deals, can you give us a sense of, you know, at the market looks like today versus, versus when you started?

Speaker #6: I mean, are there, is there stuff you've passed on? Are there opportunities you've missed out on? Obviously, getting a deal in the door is, is, is one of your five priorities.

Speaker #6: Just trying to understand what the market looks like more broadly.

Speaker #7: Sure. No, good estion. I, I wouldn't say we've missed out on anything. I mean, there have been things that we've been somewhat interested in, but we look at, how they fit into our model, where we think the value is, and, we're certainly, willing to pay a fair market price.

Speaker #7: But if it exceeds that and we can't really find a way that it makes financial sense, then we'll pass on it. So, we've had a couple of opportunities like that, but we have numerous conversations ongoing for a whole wide variety of transactions.

Speaker #7: And, and so, those go. you know, I've, I've been set all along. I want to be patient because I want to make sure we do the right transaction for the business.

Speaker #7: and as we are executing on rollover on and executing on everything else, we're ally strengthening the balance sheet. So, that gives us a little bit wider of a fishing ground, to look at.

Speaker #7: So, good conversations ongoing. I said, you know, I'd like to get something done this year. We'll see where that goes.

Speaker #6: And then one final one, if I may. when you guys laid out the 108 to 123 guidance, the big swing factor in there was the potential for a new generic entrant into the Indocin space.

Speaker #6: but now I guess that the top has been reduced because of Otrexate. do you given how far along we are into the year, do you think the swing is still going to be potentially 10 million primarily Indocin?

Speaker #6: And what, what else is, what, what, what would move that, you know, that, that number 10 million? From, from bottom to top.

Speaker #7: Yeah, well, I'll, I'll will be in a much better position, Thomas, when we get to November to narrow this range considerably. There's other strategic things we're oking at that could impact that.

Speaker #7: It's not just Indocin, but there are other things that I really don't want to get into that could impact that range. But, as I said, as we get through the third quarter here, and I come back in November, I'll be able to narrow that range significantly.

Speaker #6: Got it. Appreciate it. Thank you y much.

Speaker #7: Sure.

Speaker #2: The next question comes from Ram Selvar. Sorry. Selvaraju with HC Wainwright. Your line is open.

Speaker #8: Thanks very much for taking my estions. firstly, I just wanted to, address the housekeeping item. In the wake of the divestiture to Assertio Therapeutics, and the ATIH transaction, can you just, review for us what remaining outstanding litigation matters there are?

Speaker #8: Under Assertio Holdings, or if at this juncture there aren't any?

Speaker #7: So, at this juncture, Ram, most of it is just some, shareholder lawsuits that we're working our way through. Most of everything else has been closed out, and we've moved on.

Speaker #7: So, as I said in my remarks, we hope to have, we hope to have that cleaned up and resolved by the end of this year.

Speaker #7: Or, or early next year, but made significant progress in reducing, you know, kind of our legal spend around defending different lawsuits.

Speaker #8: Great. Secondly, I was wondering if you could just characterize some of the principal emergent drivers of rollover on pull-through demand. And how robust you expect those to be going forward, particularly not only as we go into the second half of 2025, but also looking ahead to 2026.

Speaker #7: Well, I think the biggest thing is expanding our customer base. You know, we significantly expanded our customer base during the first and second quarter, which is one of the reasons that you saw demand grow by almost 20%.

Speaker #7: And that isn't even a full quarter. So, we expect demand to continue to grow. both in the clinic space where we primarily focus, but also, we think that as we go through the second half of this year, and especially into 2026, we'll see more, we'll see more commercial utilization.

Speaker #7: And we're working , securing that right .

Speaker #8: And then just two more very quick ones. Firstly, on Otrexate, can you remind us about the length of exclusivity that still remains for this product?

Speaker #8: And then also, if you could characterize for us, you know, now that Assertio has elected to halt commercialization activities on Otrexate, you ow, what does this, effectively, mean for the SG&A line?

Speaker #8: You know, what does that translate into in terms of savings? you ow, what activities are no longer necessary? And also, how does that perhaps you're not in a position to comment on this now, but any helpful color would be appreciated.

Speaker #8: How does the absence of commercial activity for this product impact your ability to monetize it on a strategic basis going forward? Assuming that your priority has now shifted from active commercialization to divestiture.

Speaker #7: Yeah, so, good questions, Ram. So, I'll, I'll take part of it, and then I'll have Ajay take part of it. But if you think about Otrexate, I an, we have a, we had seven assets, or we have seven assets across the variety of therapeutic areas.

Speaker #7: with, Otrexate being, primarily rheumatoid arthritis. So, that's not really a necessarily a, a core commercial focus on us. And for us, we made the decision to focus our commercial efforts around rollover on in SimpliSam because those are the products that we see the most, most growth potential in.

Speaker #7: we had reached a point with Otrexate where, although it was driving top line, there was, not much there as far as profit. So, in addition, you know, instead of spending additional funds to it, decided to redirect those to where we, we thought we could ally grow.

Speaker #7: That doesn't mean that, Otrexate couldn't be profitable in somebody else's hand. It might have a more complementary portfolio that they could add to their, a rheumatology basket of products.

Speaker #7: But, Otrexate is methotrexate. There's no IP left on methotrexate in and of itself. It's combined in a pen from Halozyme, so it would be difficult to maybe duplicate the exact product because of the pen-drug delivery combination.

Speaker #7: But methotrexate itself has no, has no IP, so there's other versions of it out there available in the market. Ajay, I'll let you talk about some of the cost savings.

Speaker #5: Yeah, Ram. We're expecting a good amount of cost savings from an SG&A perspective on Otrexate next year. It's in the range of $2 million to $3 million.

Speaker #5: which would comprise of any kind of direct spend we had on it from a digital marketing perspective and the annual PDUPA fee. Obviously, this is going to offset by kind of the top line degradation.

Speaker #5: overall, part of the decision was as we looked at the pricing competitive pressures that were there and top line. And the cost pressures that are there from the, device combo, it ended up being fairly neutral to EBITDA for this year, for the remainder of the year.

Speaker #5: and that's why you actually see a benefit in our narrowing of the EBITDA range upwards on the low end.

Speaker #8: Okay. Thank you much.

Speaker #2: The next question comes from Naz Rahman with Maxim Group. Your line is open.

Speaker #9: Hi, everyone. Congrats on the progress, and thanks for taking our questions. I just have a few. I want to start on rollover. At this point, how much of an effect are you seeing from the same-day dosing data?

Speaker #9: If any, and I guess more, more towards that point, when do you start, when do you expect to see larger and greater effects from the same-day dosing data?

Speaker #9: on sales?

Speaker #7: No, that's great. Good question, Naz. Thanks. We're starting to see increased levels of interest, and we think we've observed increased levels of interest in same-day dosing since we presented the results at the end of last year and in the first quarter of this year.

Speaker #7: So, it's certainly an interest among providers. We know that it's a growing interest. We hope to, we've submitted to a peer-reviewed journal. Hope to have publication sometime this year.

Speaker #7: and, I ink once that that happens, that'll be another catalyst and ultimately, you ow, the goal would be to get this into the NCCN guidelines.

Speaker #7: Whether that, materializes or not, we obviously don't control. And when, but, that really today is not built into any of our projections. So, that would definitely be an upside.

Speaker #7: And as we move to publication, we'll take a look and see, you know, what kind of lift we're getting from that. But there's definitely interest in same-day dosing.

Speaker #7: and the interest is increasing.

Speaker #8: So, I guess on that point, based on everything you now know in terms of publication and timelines, what are you thinking now in terms of timelines for getting the same-day ing into NCCN guidelines?

Speaker #7: Well, I think the first step is publication. As I mentioned, we hope to have publications still this calendar year. We're definitely making progress on that.

Speaker #7: And I would say, NCCN probably, by the middle of 2026, it's possible it could be earlier, but not probable.

Speaker #8: Understood. And on SimpliSam, now that you're accelerating efforts for promotion, based on what you've seen thus far, I guess, what sales levels do you think you could return or get SimpliSam to at this point, based on what you're anticipating?

Speaker #7: net sales number?

Speaker #8: Yeah, net sales and scripts. Yeah.

Speaker #7: Yeah, I mean, I think net sales could ultimately be between $25 million and $30 million in the next several years, so kind of double from where we are today.

Speaker #7: I think there's definitely, there's definitely growing awareness, and I think that, SimpliSam is benefiting just from a share of voice out there and, and providers recognizing that it's there and how, how to, how to prescribe it and how patients can get it.

Speaker #8: Got it. And just one last question. Can you tell your point on resources and promotional efforts from Otrexate? Is there a potential to divert some of those resources, or I guess that time to rollover on?

Speaker #8: And SimpliSam, like, why don't, why don't you think those, do you think those products could grow faster with the Otrexate resources, or do you think there's not much of a difference there?

Speaker #8: I guess logistically.

Speaker #7: No, I mean, we are redirecting resources from other products to SimpliSam and, rollover on, but that's already built really into our projections. I an, this is the Otrexate is not a decision that we made yesterday.

Speaker #7: You know, we've been looking at Otrexate for quite some time. And it was built into this year's plan and projections, other than the net sales piece, which we adjusted for.

Speaker #8: Got it. Thank you for taking my questions.

Speaker #7: Yep.