NASDAQ:ASRT Assertio Q3 2024 Earnings Report $0.66 +0.01 (+1.50%) Closing price 04:00 PM EasternExtended Trading$0.67 +0.01 (+1.09%) As of 07:54 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. ProfileEarnings HistoryForecast Assertio EPS ResultsActual EPS-$0.03Consensus EPS -$0.05Beat/MissBeat by +$0.02One Year Ago EPS-$0.01Assertio Revenue ResultsActual Revenue$29.20 millionExpected Revenue$29.29 millionBeat/MissMissed by -$90.00 thousandYoY Revenue GrowthN/AAssertio Announcement DetailsQuarterQ3 2024Date11/11/2024TimeAfter Market ClosesConference Call DateMonday, November 11, 2024Conference Call Time4:30PM ETUpcoming EarningsAssertio's Q2 2025 earnings is scheduled for Wednesday, August 6, 2025, with a conference call scheduled at 4:30 PM ET. Check back for transcripts, audio, and key financial metrics as they become available.Conference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by Assertio Q3 2024 Earnings Call TranscriptProvided by QuartrNovember 11, 2024 ShareLink copied to clipboard.There are 8 speakers on the call. Operator00:00:00Thank you for standing by. My name is John, and I will be your conference operator today. At this time, I would like to welcome everyone to the Assertio Holdings Third Quarter Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session. Operator00:00:25I would now like to turn the call over to Matt Kreps, Investor Relations. Please go ahead. Speaker 100:00:31Thank you, John. Good afternoon and thank you all for joining us today to discuss Assertio's Q3 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 release and tables in conjunction with today's discussion. Speaker 100:00:52With me today are Brendan O'Grady, our Chief Executive Officer and A. J. Patel, Chief Financial Officer. In just a moment, Brendan will open her remarks and provide an overview of the business, then A. J. Speaker 100:01:02Will cover our financial results. After that, we will 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 this afternoon's press release as well as Assertio's filings with the SEC. SEC. Speaker 100:01:24These and other risks are more fully described in the Risk Factors section and other sections of our Annual Report on Form 10 ks 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. And with that, I will now turn the call over to Brendan. Please go ahead. Speaker 200:01:48Thanks, Matt. Welcome everyone to today's call and thank you for joining. I'd like to start by wishing you all Happy Veterans Day, especially to our retired and active service members and their families. In addition to our usual quarterly performance, there are 2 other relevant issues that I would like to begin my remarks by addressing. The first is the unwarranted attack on Assertio stakeholders by Mr. Speaker 200:02:12Alex Parker of Buxton Hemsley Group that was launched this past Friday, November 8. I'm sure many, if not most of you have seen the letter I released this morning addressing Mr. Parker's rambling manifesto that he put out last Friday. Normally, I would not validate such conduct by speaking about it, but because of the numerous falsehoods and baseless allegations that had such an impact on our share price, I want to use this opportunity to address this head on. While we have taken Mr. Speaker 200:02:41Parker's allegations seriously and have looked into every single one of them, we found them all to be without merit. We have communicated that to Mr. Parker on numerous occasions, while at the same time refusing to bow to his demands of cash payments or a seat on Assertio's Board to which he would add 0 and I stress 0 value. And most importantly neither of which would be in the best interest of shareholders. If you happen to take the time to read through his less than cogent 24 page document, he is essentially making 3 basis claims. Speaker 200:03:17While I do not want to rehash my entire letter, I do want to take a minute to set the record straight specifically on those claims. 1st and foremost, rolvedon is a safe and effective product. I am 100% confident in that. Assertio was aware of the whistleblower claims around Rovidone before the acquisition of Spectrum. In fact, those claims were investigated by 3 different professional outside firms. Speaker 200:03:45The experts involved in those investigations determined that the FDA was supplied with all relevant and required data that led to Rolodon's approval. Rolodon has now been in the market in the U. S. And South Korea for 2.5 years and has demonstrated its safety and efficacy in the clinic with patients in real world settings. It is well tolerated by patients and has been well received by providers. Speaker 200:04:122nd, the impairment charges had nothing to do with any purported roll it on safety claims. Assertio simply followed clearly established accounting principles as we always do in regards to any asset. Our disclosures clearly explain the impairment and how any and why it was calculated the way that it was. It is that simple. 3rd, no payment to the alleged whistleblower were ever made. Speaker 200:04:39The proposed payments Mr. Parker is referring to is related to an employment claim that was raised by a disgruntled former employee. That employee brought claims forward about rolvedon as leverage to boost the value of a settlement or reverse their pending termination. After a thorough investigation, it was determined those claims and allegations were false and without merit. The employee was subsequently terminated as part of a reduction in force and the case was later dismissed without any payment ever being made. Speaker 200:05:11Finally, Mr. Parker's rambling rehash of connecting dots where none exist or misrepresenting long past settled issues is right with false statements and mischaracterizations that we have pointed out to him numerous times, including the circumstances and reasons for the departure of a former Board member. While I don't expect his desperate attacks will stop, you should know that there is nothing here and we will vigorously defend our reputation using all legal and regulatory means at our disposal. Today will be my last comments on this matter as I turn 100 percent of my focus to the business. So now, with that out of the way, I'd like to focus my comments back to the business and the progress we are making in stabilizing the company and positioning it for transformational growth in the coming months. Speaker 200:06:03As noted in our earnings release today, I would like to announce that during the November 7th Board of Directors meeting, Chairman of the Board, Peter Staple retired from the Board after 21 years of dedicated service and leadership. Peter was instrumental in bringing me to Assertio and although our time together was short, I appreciated his calm demeanor, deep expertise and presence on the Board. I cannot thank him enough. In addition, Doctor. Jeff Visserka has stepped back from the Board to focus on his many other business interests. Speaker 200:06:34We thank Doctor. Visserka for his service and providing continuity through the acquisition and integration of Spectrum. His insights into the GCSF and oncology markets were invaluable and we will miss his contributions to the Board. Both of these departures and continued transition to the Board have long been in the planning. With that, I'm also happy to announce that Heather Mason, Independent Director has been appointed as Chairwoman of the Board. Speaker 200:07:01Heather has been on the Assertio Board for over 5 years, serving as Interim CEO prior to my joining, and she has a wealth of industry experience. I look forward to continuing to work with Heather in her newly expanded role. I am also excited to announce that David Stark has joined the Assertio Board effective November 7. David is an experienced litigator and senior pharmaceutical executive, recently retiring from Teva as Chief Legal Officer. David brings a wealth of industry and relevant legal expertise from his 20 plus years at Teva. Speaker 200:07:34David and I were colleagues at Teva and I'm excited to be working with him again in this new capacity. Now on to the business. 1st and foremost, let me just say, I'm very pleased with where we are today as a starting line for growth. As I've said previously, this year is about stabilizing the organization as we transition from Indosyn as our lead product to Rolvadon and at the same time positioning ourselves for more transformational growth in the coming months. It is worth restating that we have a solid balance sheet, modest debt on favorable terms and a good stable of growth core and legacy assets led by Rolledad. Speaker 200:08:15We also have an excellent team of dedicated professionals who know this industry extremely well, giving us the opportunity to add or enhance key capabilities as we grow. Also important to note is that our capabilities in lean model will allow us to be relatively sector agnostic, broadening the landscape for new assets and letting us focus on those that best fit our commercial parameters. For all these reasons, we are well positioned to deliver value for patients and providers we serve as well as shareholders and employees as we build a significant branded specialty business through acquisition, integration and a focused go to market strategy. As I said on my first call with you in August, our focus will remain on steady execution, driving cash flow and identifying new assets we can add to bring further scale to Assertio's platform. Now turning to performance and I'll first address Rolvadon. Speaker 200:09:08Rolvadon Q3 sales were essentially steady quarter over quarter, showing continued solid demand. We continue to retain a stable share around 33% in the oncology community a community oncology clinic space where we have primarily focused. We did see a dip in demand due to some typical seasonality that could occur in the Q3 as well as some shift in the community oncology clinic space specifically Part B. This was offset by the addition of new customers enabling further expansion into the hospital space and community oncology clinics where we did not have a presence. There are segments these are segments that will be important for further future growth. Speaker 200:09:51We remain focused on using our position, a safe and effective non biosimilar G CSF to offer stability to providers and patients, positioning ourselves as a predictable, reliable solution at a more stable price, and of course this is a market dynamic, but our message continues to resonate. Additionally, rolodont same day dosing trial wrapped up in early Q2 and I'm excited to announce that the data will be presented as a poster exhibit at the San Antonio Breast Cancer Symposium in December. I'm excited about rolodadon as it's going to play a key role for us over the next several years, both in our current clinic focused market as well as hospital as well as the hospital market as we prepare to expand into those additional opportunities. As the only available G CSF approved under a BLA without biosimilar copies, there may also be opportunities for label expansion. We're in the very early phases of making that assessment. Speaker 200:10:49Now a couple of words about IndusInd. On IndusInd, we continue to manage the lifecycle process and drive cash flow generating from the asset. Although there is some compounding activity to date, we have only 1 generic competitor. Our share of the market is holding steady at our internal target levels, which is around 50% of the ex compounding market. We will compete to hold our rightful share of the market and at the same time we will work to maintain our share and optimize price. Speaker 200:11:17Having worked at Teva for more than 20 years, this is something I am very familiar with and know how to do. Looking at SYMPAZAN, while this is a smaller asset, we believe that has underpenetrated the market and there is room for growth. We also understand that SYMPAZAN is especially responsive to key opinion leader awareness and support. I think I mentioned on the last call that we're piloting and executing sales and marketing tactics designed to drive prescriber awareness and prescription growth in key markets. Although early, we have seen record demand levels in SYMPAZAN prescriptions in July August as a result of these activities. Speaker 200:11:56This is a product I like from the beginning of my time at Assertio. It serves a specific unmet medical need. We have a broad coalition of growing support among patients, caregivers and providers and look to expand both awareness and use of SYMPAZAN going forward. And then lastly, just a quick word about some of our remaining assets. And I'd like to just talk a little bit about how to characterize the business. Speaker 200:12:21I see it really in 3 main buckets. I see a growth asset bucket. This is clearly rolled out and I've spoken about it. I see a core asset bucket. This is SYMPAZAN and SPRIX. Speaker 200:12:32And while I discuss SYMPAZAN and our plan there, I've not said much about SPRIX. What I will say about SPRIX is that it serves a significant unmet medical need by providing opioid level pain relief. In fact, our indication states that SPRIX is indicated in moderate to moderately severe pain that requires analgesia at the opioid level. There continues to be a focus on non opioid pain relief and the No Pain Act, which expands reimbursement for non opioid postsurgical options starting January 1, 2025 could be an opportunity that we are looking at very seriously for SPRIX. If nothing else, it brings the need for non opioid pain relief back to the forefront and reason to believe that SPRIX could be a bigger asset for us than it currently is. Speaker 200:13:21The last bucket is our legacy assets. These are our tail products that have lost exclusivity or face very difficult market dynamics. In this bucket, it's all about asset optimization and includes IndusInd and Cambia among others. I understand how to extract maximum value out of assets like this and will continue to focus on cash generation in this bucket. With that, I'll conclude my remarks and I'll hand it over to A. Speaker 200:13:46J. Patel, our Chief Financial Officer. Speaker 300:13:49Thanks, Brendan. Today, I would like to cover our financial results for the Q3 of 2024. Before I begin, I want to note that my commentary will focus on sequential comparisons to the prior quarter. Comparisons to the prior year are less relevant given the acquisition of Spectrum and generic competition of INDOCIN that occurred in the prior year Q3. Also, I want to remind everyone that Rovidone is now our lead asset and brings with it the associated changes in margin, operating cost structure and cash flows that you are seeing in our results throughout this year. Speaker 300:14:26For the Q3 of 2024, our total product sales were $28,700,000 down slightly from $30,700,000 in the 2nd quarter, primarily due to Rovidone sales being offset by the expected decline in INDOCIN. Rovidone sales were $15,000,000 in the 3rd quarter compared to $15,100,000 in the 2nd quarter. The change was driven by continued volume growth offset by lower net pricing. We continue to hold about 1 third share in our served markets. Indicine sales were $5,700,000 in the 3rd quarter, down from $6,900,000 in the 2nd quarter, driven by lower net pricing as a result of generic competition. Speaker 300:15:15In terms of volume, we continue to target and hold an approximate market share split. Reported gross margin in the 3rd quarter improved to 74% compared to 71% in the 2nd quarter, primarily due to level of inventory step up amortization and write downs from prior quarter not repeating. Turning to operating expenses. SG and A expense was $16,700,000 in the 3rd quarter, decreased from $18,400,000 in the 2nd quarter. R and D expense in the 3rd quarter was relatively flat at approximately $1,000,000 On an adjusted basis, excluding stock compensation, D and A and change in fair value, adjusted operating expense was $16,400,000 in the 3rd quarter, down from $17,700,000 in the 2nd quarter. Speaker 300:16:14The decrease was primarily due to lower sales and marketing and other G and A costs, partially offset by net higher legal related charges. GAAP net income for the 3rd quarter was a loss of $2,900,000 down from a loss of $3,700,000 in the 2nd quarter. Because GAAP net income includes a number of non cash expenses, we also use adjusted EBITDA as a good indicator of the operating performance of core business. Q3 adjusted EBITDA was a positive $5,300,000 increased from $5,000,000 in the 2nd quarter due to lower operating expenses, partially offset by lower product sales. Please refer to our press release for detailed reconciliation of our adjusted EBITDA results. Speaker 300:17:09Crossing over to cash flow and our balance sheet. As a reminder, we invest cash into short term investments. Therefore, our reference to total cash position includes both cash and cash equivalents and short term investments. Total cash at the end of the quarter was $88,600,000 effectively flat to the $88,400,000 in the 2nd quarter and debt remained unchanged at $40,000,000 As we previously noted, quarterly operating cash flows will fluctuate due to timing of working capital in terms of cash receipts and payments due to shift in product mix from IndusInd to Ovidon. 3rd quarter operating cash flows were negligible and were impacted by timing of working capital from cash collection and lower product sales. Speaker 300:18:01Year to date, we have generated $15,000,000 in cash flows from operations. With that, we will open the floor to questions from our covering research analysts. Operator, please go ahead with the instructions. Operator00:18:18Thank Thank you. Our first question comes from the line of Thomas Flyton with Big Street Capital Markets. Please go ahead. Speaker 400:18:46Hey, good afternoon, guys. Congrats on the good quarter. A. J, you didn't mention anything about guidance. Any thoughts on that for us? Speaker 300:18:53Yes. Thanks for the question, Thomas. You're right. At this point, we would have liked to narrow the range, but we still see a flux in few key areas for the remainder of the year. Therefore, we're going to keep the remaining guidance range that's out there. Speaker 300:19:08Some of the areas we're continuing to focus on is first, focus of stabilizing the business as we cross over from INDOCENT to Rovidone. Secondly, as we continue to monitor the generic competitive landscape of INDOCENT. And then third is the dynamic pricing and volume activity occurring in the GCS market landscape. Speaker 400:19:32Great. And then as a follow-up or not a follow-up. Brendan, you had spoken in the last quarterly call and I think in some investor conferences about your desire to maybe do a smaller deal this year and then maybe something more transformative in 2025. Could you give us your updated thoughts on that? Speaker 200:19:50Yes. So we continue to look at the landscape of what's available and what's out there. And there are assets that we think we could execute whether they're smaller, whether they're larger. But the further we go, I'm starting to think maybe we do something a little bit more robust in the near term than there may be a small tuck in. So it really kind of depends on what's out there, what the price is, what we can get and how we think it fits with our model. Speaker 200:20:15So I'm optimistic. I think there's lots of doable deals out there. But I've said before, I want to make sure it's the right fit. So I don't want to jump into something just because we feel like we need to. I want to make sure that it's the right thing for Assertio and we're paying the right price for it. Speaker 400:20:35Excellent. Appreciate you taking the question. Speaker 200:20:37Thank you. Sure. Thanks. Operator00:20:41Your next question comes from the line of Nazaraman with Maxim Group. Please go ahead. Speaker 500:20:47Hi. Thanks for taking my question. They're both on rolling on. I'll start with this. In regards to pricing, where do you think the pricing decline sort of stable out? Speaker 500:20:58Do you think you've reached stable prices or do you think there's still room for the pricing that pricing to decline? Speaker 300:21:07Yes. Hey, Nas, this is A. J. Thanks for the question. I would say, the GCSF landscape is very competitive, especially with the biosimilars, and some of the more recent entrants in the last few years really driving pricing. Speaker 300:21:23Therefore, in this market we are somewhat hindered by what the market competitors will continue to do. We have seen pricing declines over the last few quarters, which we anticipate the trend would continue, as market share starts to equalize. But one of the things we're absolutely focused on is the market that we operate in from a Medicare Part B perspective and maintaining our, one of our leading market share position there. Speaker 500:21:53Got it. That was helpful. And my follow-up question is following the same day dosing data, could you talk a little bit about the logistics and potential timeline to get that into NCCN guidelines? Like what has to happen there and how long does that take? Speaker 200:22:09Yes. So thanks for the question. So again, we'll make the data public here in December. And then I think it is roughly about a 6 month window for us to work with MCCN for them to consider. That doesn't mean that it would be mid year, but I think the earliest it could potentially be is mid year. Speaker 200:22:30So we haven't had those Speaker 400:22:31discussions of those conversations yet, but I think it will be somewhere between the middle and Speaker 200:22:31the back of the conversations yet, but I think it will be somewhere between the middle and the back end of next year. Speaker 500:22:39Got it. Thanks for taking my questions. Speaker 200:22:42Sure. Operator00:22:44Thank you. Our next question comes from the line of Scott Henry with AGT. Please go ahead. Speaker 600:22:56Thank you and good afternoon. A couple of questions. First on rolvedon, Q1 roughly $14,500,000 2nd quarter $15,100,000 3rd quarter $15,000,000 guidance I assume is still in place of roughly $60,000,000 for 2024. So we've got about 4 quarters right around that $15,000,000 mark. Do you think it's basing out here for future growth? Speaker 600:23:28Or will maybe the growth be slower? Just trying to get your sense of there's a lot of moving parts here in that market of how we should think about growth for Rolvedon in 2025 and beyond. Speaker 200:23:44Yes. No, it's a great question. So thank you. And you're right, right. You've seen about 15,000,000 dollars Q1, Q2, Q3 has been relatively stable. Speaker 200:23:54And I think if you think about the year that roughly $16,000,000 in sales is right about where we think we'll be. But as we enter 2025, I mean in 2024, we've been very focused in the community oncology clinic space, as A. J. Said, focusing in the Medicare Part B space, where we maintain about a third of that market share. As we move into 2025, we do think that further growth is not only possible, but that's what we're planning for, as we expand beyond that clinic space into hospitals and so forth. Speaker 200:24:30So we are planning for growth and we're approaching this category and we're approaching rolvedon is a long term play. We're not looking for dramatic spike in any one particular quarter. We're looking at this asset over the long term. So we do think that we'll see continued growth and we have plans to drive continued growth with Volva. Speaker 600:24:54Okay, great. And SG and A in the quarter was on the it seemed pretty low, it's a good thing. Do you think that's a fair number to extrapolate going forward? Is that kind of the run rate you have currently? Speaker 300:25:13Yes, Scott. Good question. Yes, I would say generally in our business, the second half of the year from an SG and A is generally lower as a lot of our S and M initiatives occur in the first half of the year. With that, we also additionally had additional kind of restructuring and retransition we did with the company in the beginning in the Q1 of the year. So that kind of reflected a higher run rate. Speaker 300:25:38I would say the average of the last two quarters is sufficient for the remainder of the year. Speaker 600:25:45Okay, great. And the final question, I just wanted to ask on the Board update. Yes, I've covered the company for a while. I believe there was a retirement a mandatory retirement age for Board members. Was that a factor in Peter Staple retiring, if I recall that correctly? Speaker 600:26:10And if you could give any color on Doctor. Visserka retiring. I think he said something earlier, but I might have missed it. Speaker 200:26:20Yes, sure. No, I'd be happy to address both. So, I mean, Peter has been on the Board for 21 years. He's seen a lot of different versions of Assertio and I think has worked with 6, 7 or 8 CEOs. So, while I think Peter was approaching the term age or had approached it, I think there was a plan for Peter, to step back for a while and retire from the Board. Speaker 200:26:43He stayed on largely because there was the transition between the former CEO, Heather, becoming the Interim CEO to bring me on board. And then after I was on board, this transition between Peter and Heather was planned to take place. So this has been a while in the making. I think Peter has been phenomenal and he served Assertio well over the years. As I said in my opening comments, very calm demeanor, very experienced professional and really, really what I believe a great Board member and I appreciate his contributions. Speaker 200:27:21In regards to Doctor. Vaserca, Doctor. Vaserca came from Spectrum. He was on the Spectrum Board, I believe. And I think what Doctor. Speaker 200:27:30Vaserca did for Assertio was really help with that integration and provide continuity as we integrated Spectrum into Assertio and started to really understand the G CSF market and the oncology market in the oncology clinic space. So I don't think, and I don't want to speak for Doctor. Visserka, but I don't think it was ever his long term intention to stay on the Assertio Board forever. In fact, he probably, stayed longer than planned, but I think he's thinking that he has a lot of outside other business interests that he needs to pay attention to. So this is a good time for him to step back from the Board as well. Speaker 600:28:05Okay, great. Thank you for that color and thank you for taking the questions. Speaker 200:28:09Sure. Sure. Operator00:28:12Our next question comes from the line of Ram Selvaraju with H. C. Wainwright. Please go ahead. Speaker 700:28:20Thanks very much for taking my questions. I just wanted to ask 1st and foremost about what the underlying market dynamics are that you're seeing that are driving new customers to choose Rolledad. If you could comment on that in some additional granularity, please. Speaker 200:28:38Well, I'll just give you my take first and then A. J, if you want to jump in and say anything, you're welcome to. But look, I think that rolvedon is, competes as we said in a very dynamic market place. It competes with other 6 or 7 or 8 other GCSFs. And it depends upon the actual slice of the market that you're competing in. Speaker 200:28:59You know that we compete in the clinic Medicare Part B space. We've been successful there. I think physicians recognize and providers recognize that rolodon is a very safe and effective product. And I think that that will be underscored when we see the results of the same day dosing. Having said that, a lot of this is a contract play and a lot of it is about access and a lot of it is about do you have the right ASP formula, how are you managing ASP erosion, all of those things. Speaker 200:29:31So I think at the end of the day, a lot of times this comes to a contract play that is largely sometimes not even a physician that's making that choice. It might be a practice manager. So, patients may be unaware of the particular GCS that they're getting. Some may be aware, some may not be aware. But overall, it's decided kind of at the clinical level, a lot of times by decision makers that way. Speaker 200:29:57Ajay, anything else Speaker 300:29:58to add? No, I think Brendan hit it spot on, right? The former in terms of the appeal of the product itself helps us get kind of into the door. And then the second on the contracting side, has helped us with the stickiness of sustaining our leading market share in the oncology space. Speaker 700:30:15And then just as a follow-up, I just wanted to see if A. J, you wanted to comment on what you see as future trends on the gross margin front. If you think that sustainably maintaining gross margins in the sort of low to mid-70s is possible as the product and revenue mix evolves? Thanks. Speaker 300:30:34Yes. No, thanks for that question. Yes, I think as I mentioned to Thomas, right, I think we're keeping our previously announced guidance for 2024 in line. We're not ready yet to comment anything beyond kind of 24 here. So previously stated comments on gross margin that year over year there will be a gross margin erosion as we shift from IndusInd, which was a highly accretive gross margin product with very little commercial activity behind it to Lovidon, which is a biologic and carries a higher COGS rate and additionally has the commercial spend behind it. Speaker 300:31:11So we do continue to see that shift occurring into Q4 as well. But we are absolutely focused on from a pricing standpoint, maintaining that blended between 70% 75% gross margin rate for 2024. Speaker 700:31:34Thank you. Operator00:31:37As there are no further questions, that concludes the Q and A session. I would like to turn the conference back over to Brendan O'Grady for any closing remarks. Speaker 200:31:47Thank you. And I appreciate everyone who has joined us today. I just want to reiterate that I believe we have a great platform, an excellent team and a sound strategy, as well as a balance sheet that will help support further growth. I hope that today's call has continued to demonstrate our ability to deliver steady execution on the commercial business we have today, as well as our commitment to finding the right assets to further grow the platform. If you'd like to arrange a meeting or at an upcoming event or an update call with management, please contact Matt Kreps directly using his information provided in the press release and we'd be happy to schedule a time to speak. Speaker 200:32:28And thank you all again for joining us today. Operator00:32:33That concludes today's meeting. Thank you for your participation. You may now disconnect.Read morePowered by Key Takeaways The CEO directly addressed an activist letter by Buxton Hemsley’s Alex Parker, labeling the allegations about Rolvadon safety, impairment charges, and whistleblower payments as baseless and confirming no merits were found. Assertio announced significant leadership changes: chairman Peter Staple retired, Dr. Jeff Visserka stepped down, Heather Mason was named Board Chairwoman, and David Stark joined as an independent director. Rolvadon sales held steady at about $15 million in Q3 with ~33% share in community oncology clinics, offsetting seasonality with new hospital customer wins; same-day dosing trial data will be presented in December. Legacy and core products saw stable and growing demand: Indocin sales at $5.7 million maintaining ~50% ex-compounding market share, SYMPAZAN prescriptions hit record levels after targeted marketing, and SPRIX poised for growth under the No Pain Act. Q3 financials: total product sales of $28.7 million, gross margin improved to 74%, GAAP net loss narrowed to $2.9 million with positive adjusted EBITDA of $5.3 million; cash and short-term investments of $88.6 million versus $40 million debt, with full-year guidance unchanged. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallAssertio Q3 202400:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) Assertio Earnings HeadlinesAssertio to Participate in the Alliance Global Partners Healthcare Company Showcase on May 21, 2025May 19, 2025 | globenewswire.comAssertio outlines 2025 transformation phase with $108M-$123M revenue guidance while advancing Rolvedon and Sympazan growthMay 13, 2025 | seekingalpha.comTrump’s Wealth Reset: Could You Be The First Beneficiary?Trump's Reset Can Give Birth To America's Greatest Era Yet A 90-Year cycle may end soon, creating real wealth for early adopters In 1933, Executive Order 6102 forced everyday Americans to hand over their gold at a fixed rate. Everyday citizens lost a sizable amount of their hard earned wealth at the stroke of FDR's pen.June 6, 2025 | American Hartford Gold (Ad)Assertio Holdings, Inc. (NASDAQ:ASRT) Q1 2025 Earnings Call TranscriptMay 13, 2025 | insidermonkey.comAssertio Holdings, Inc.: Assertio Reports First Quarter 2025 Financial ResultsMay 13, 2025 | finanznachrichten.deAssertio Holdings Inc (ASRT) Q1 2025 Earnings Call Highlights: Navigating Challenges with ...May 13, 2025 | finance.yahoo.comSee More Assertio Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Assertio? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Assertio and other key companies, straight to your email. Email Address About AssertioAssertio (NASDAQ:ASRT), a commercial pharmaceutical company, provides various products to patients in the United States. Its pharmaceutical products include INDOCIN, an oral and suppository solution for the treatment of moderate to severe rheumatoid arthritis, including acute flares of chronic disease; ankylosing spondylitis and osteoarthritis; and acute painful shoulder and gouty arthritis. It also provides Sympazan, a benzodiazepine for the adjunctive treatment of seizures related with lennox-gastaut syndrome in patients aged two years of age or older; CAMBIA, a non steroidal anti inflammatory drug (NSAID) for the treatment of migraine pain, nausea, photophobia, and phonophobia; Zipsor, a NSAID for relief of mild to moderate pain in adults; SPRIX, a NSAID for the short term management of moderate to moderately severe pain that requires analgesia at the opioid level; Otrexup, a single-dose auto-injector containing a prescription medicine and methotrexate that is used to treat patients with severe, active rheumatoid arthritis, and active polyarticular juvenile idiopathic arthritis, as well as treat adult with severe, recalcitrant, and disabling psoriasis; and ROLVEDON, a long-acting granulocyte colony-stimulating factor that is indicated to decrease the incidence of infection caused by febrile neutropenia. The company was formerly known as Assertio Therapeutics, Inc. and changed its name to Assertio Holdings, Inc. in May 2020. Assertio Holdings, Inc. was incorporated in 2020 and is headquartered in Lake Forest, Illinois.View Assertio ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Broadcom Slides on Solid Earnings, AI Outlook Still StrongRed Robin's Comeback: Q1 Earnings Spark Investor HopesOllie’s Q1 Earnings: The Good, the Bad, and What’s NextBroadcom Earnings Preview: AVGO Stock Near Record HighsUlta’s Beautiful Q1 Earnings Report Points to More Gains Aheade.l.f. 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There are 8 speakers on the call. Operator00:00:00Thank you for standing by. My name is John, and I will be your conference operator today. At this time, I would like to welcome everyone to the Assertio Holdings Third Quarter Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session. Operator00:00:25I would now like to turn the call over to Matt Kreps, Investor Relations. Please go ahead. Speaker 100:00:31Thank you, John. Good afternoon and thank you all for joining us today to discuss Assertio's Q3 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 release and tables in conjunction with today's discussion. Speaker 100:00:52With me today are Brendan O'Grady, our Chief Executive Officer and A. J. Patel, Chief Financial Officer. In just a moment, Brendan will open her remarks and provide an overview of the business, then A. J. Speaker 100:01:02Will cover our financial results. After that, we will 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 this afternoon's press release as well as Assertio's filings with the SEC. SEC. Speaker 100:01:24These and other risks are more fully described in the Risk Factors section and other sections of our Annual Report on Form 10 ks 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. And with that, I will now turn the call over to Brendan. Please go ahead. Speaker 200:01:48Thanks, Matt. Welcome everyone to today's call and thank you for joining. I'd like to start by wishing you all Happy Veterans Day, especially to our retired and active service members and their families. In addition to our usual quarterly performance, there are 2 other relevant issues that I would like to begin my remarks by addressing. The first is the unwarranted attack on Assertio stakeholders by Mr. Speaker 200:02:12Alex Parker of Buxton Hemsley Group that was launched this past Friday, November 8. I'm sure many, if not most of you have seen the letter I released this morning addressing Mr. Parker's rambling manifesto that he put out last Friday. Normally, I would not validate such conduct by speaking about it, but because of the numerous falsehoods and baseless allegations that had such an impact on our share price, I want to use this opportunity to address this head on. While we have taken Mr. Speaker 200:02:41Parker's allegations seriously and have looked into every single one of them, we found them all to be without merit. We have communicated that to Mr. Parker on numerous occasions, while at the same time refusing to bow to his demands of cash payments or a seat on Assertio's Board to which he would add 0 and I stress 0 value. And most importantly neither of which would be in the best interest of shareholders. If you happen to take the time to read through his less than cogent 24 page document, he is essentially making 3 basis claims. Speaker 200:03:17While I do not want to rehash my entire letter, I do want to take a minute to set the record straight specifically on those claims. 1st and foremost, rolvedon is a safe and effective product. I am 100% confident in that. Assertio was aware of the whistleblower claims around Rovidone before the acquisition of Spectrum. In fact, those claims were investigated by 3 different professional outside firms. Speaker 200:03:45The experts involved in those investigations determined that the FDA was supplied with all relevant and required data that led to Rolodon's approval. Rolodon has now been in the market in the U. S. And South Korea for 2.5 years and has demonstrated its safety and efficacy in the clinic with patients in real world settings. It is well tolerated by patients and has been well received by providers. Speaker 200:04:122nd, the impairment charges had nothing to do with any purported roll it on safety claims. Assertio simply followed clearly established accounting principles as we always do in regards to any asset. Our disclosures clearly explain the impairment and how any and why it was calculated the way that it was. It is that simple. 3rd, no payment to the alleged whistleblower were ever made. Speaker 200:04:39The proposed payments Mr. Parker is referring to is related to an employment claim that was raised by a disgruntled former employee. That employee brought claims forward about rolvedon as leverage to boost the value of a settlement or reverse their pending termination. After a thorough investigation, it was determined those claims and allegations were false and without merit. The employee was subsequently terminated as part of a reduction in force and the case was later dismissed without any payment ever being made. Speaker 200:05:11Finally, Mr. Parker's rambling rehash of connecting dots where none exist or misrepresenting long past settled issues is right with false statements and mischaracterizations that we have pointed out to him numerous times, including the circumstances and reasons for the departure of a former Board member. While I don't expect his desperate attacks will stop, you should know that there is nothing here and we will vigorously defend our reputation using all legal and regulatory means at our disposal. Today will be my last comments on this matter as I turn 100 percent of my focus to the business. So now, with that out of the way, I'd like to focus my comments back to the business and the progress we are making in stabilizing the company and positioning it for transformational growth in the coming months. Speaker 200:06:03As noted in our earnings release today, I would like to announce that during the November 7th Board of Directors meeting, Chairman of the Board, Peter Staple retired from the Board after 21 years of dedicated service and leadership. Peter was instrumental in bringing me to Assertio and although our time together was short, I appreciated his calm demeanor, deep expertise and presence on the Board. I cannot thank him enough. In addition, Doctor. Jeff Visserka has stepped back from the Board to focus on his many other business interests. Speaker 200:06:34We thank Doctor. Visserka for his service and providing continuity through the acquisition and integration of Spectrum. His insights into the GCSF and oncology markets were invaluable and we will miss his contributions to the Board. Both of these departures and continued transition to the Board have long been in the planning. With that, I'm also happy to announce that Heather Mason, Independent Director has been appointed as Chairwoman of the Board. Speaker 200:07:01Heather has been on the Assertio Board for over 5 years, serving as Interim CEO prior to my joining, and she has a wealth of industry experience. I look forward to continuing to work with Heather in her newly expanded role. I am also excited to announce that David Stark has joined the Assertio Board effective November 7. David is an experienced litigator and senior pharmaceutical executive, recently retiring from Teva as Chief Legal Officer. David brings a wealth of industry and relevant legal expertise from his 20 plus years at Teva. Speaker 200:07:34David and I were colleagues at Teva and I'm excited to be working with him again in this new capacity. Now on to the business. 1st and foremost, let me just say, I'm very pleased with where we are today as a starting line for growth. As I've said previously, this year is about stabilizing the organization as we transition from Indosyn as our lead product to Rolvadon and at the same time positioning ourselves for more transformational growth in the coming months. It is worth restating that we have a solid balance sheet, modest debt on favorable terms and a good stable of growth core and legacy assets led by Rolledad. Speaker 200:08:15We also have an excellent team of dedicated professionals who know this industry extremely well, giving us the opportunity to add or enhance key capabilities as we grow. Also important to note is that our capabilities in lean model will allow us to be relatively sector agnostic, broadening the landscape for new assets and letting us focus on those that best fit our commercial parameters. For all these reasons, we are well positioned to deliver value for patients and providers we serve as well as shareholders and employees as we build a significant branded specialty business through acquisition, integration and a focused go to market strategy. As I said on my first call with you in August, our focus will remain on steady execution, driving cash flow and identifying new assets we can add to bring further scale to Assertio's platform. Now turning to performance and I'll first address Rolvadon. Speaker 200:09:08Rolvadon Q3 sales were essentially steady quarter over quarter, showing continued solid demand. We continue to retain a stable share around 33% in the oncology community a community oncology clinic space where we have primarily focused. We did see a dip in demand due to some typical seasonality that could occur in the Q3 as well as some shift in the community oncology clinic space specifically Part B. This was offset by the addition of new customers enabling further expansion into the hospital space and community oncology clinics where we did not have a presence. There are segments these are segments that will be important for further future growth. Speaker 200:09:51We remain focused on using our position, a safe and effective non biosimilar G CSF to offer stability to providers and patients, positioning ourselves as a predictable, reliable solution at a more stable price, and of course this is a market dynamic, but our message continues to resonate. Additionally, rolodont same day dosing trial wrapped up in early Q2 and I'm excited to announce that the data will be presented as a poster exhibit at the San Antonio Breast Cancer Symposium in December. I'm excited about rolodadon as it's going to play a key role for us over the next several years, both in our current clinic focused market as well as hospital as well as the hospital market as we prepare to expand into those additional opportunities. As the only available G CSF approved under a BLA without biosimilar copies, there may also be opportunities for label expansion. We're in the very early phases of making that assessment. Speaker 200:10:49Now a couple of words about IndusInd. On IndusInd, we continue to manage the lifecycle process and drive cash flow generating from the asset. Although there is some compounding activity to date, we have only 1 generic competitor. Our share of the market is holding steady at our internal target levels, which is around 50% of the ex compounding market. We will compete to hold our rightful share of the market and at the same time we will work to maintain our share and optimize price. Speaker 200:11:17Having worked at Teva for more than 20 years, this is something I am very familiar with and know how to do. Looking at SYMPAZAN, while this is a smaller asset, we believe that has underpenetrated the market and there is room for growth. We also understand that SYMPAZAN is especially responsive to key opinion leader awareness and support. I think I mentioned on the last call that we're piloting and executing sales and marketing tactics designed to drive prescriber awareness and prescription growth in key markets. Although early, we have seen record demand levels in SYMPAZAN prescriptions in July August as a result of these activities. Speaker 200:11:56This is a product I like from the beginning of my time at Assertio. It serves a specific unmet medical need. We have a broad coalition of growing support among patients, caregivers and providers and look to expand both awareness and use of SYMPAZAN going forward. And then lastly, just a quick word about some of our remaining assets. And I'd like to just talk a little bit about how to characterize the business. Speaker 200:12:21I see it really in 3 main buckets. I see a growth asset bucket. This is clearly rolled out and I've spoken about it. I see a core asset bucket. This is SYMPAZAN and SPRIX. Speaker 200:12:32And while I discuss SYMPAZAN and our plan there, I've not said much about SPRIX. What I will say about SPRIX is that it serves a significant unmet medical need by providing opioid level pain relief. In fact, our indication states that SPRIX is indicated in moderate to moderately severe pain that requires analgesia at the opioid level. There continues to be a focus on non opioid pain relief and the No Pain Act, which expands reimbursement for non opioid postsurgical options starting January 1, 2025 could be an opportunity that we are looking at very seriously for SPRIX. If nothing else, it brings the need for non opioid pain relief back to the forefront and reason to believe that SPRIX could be a bigger asset for us than it currently is. Speaker 200:13:21The last bucket is our legacy assets. These are our tail products that have lost exclusivity or face very difficult market dynamics. In this bucket, it's all about asset optimization and includes IndusInd and Cambia among others. I understand how to extract maximum value out of assets like this and will continue to focus on cash generation in this bucket. With that, I'll conclude my remarks and I'll hand it over to A. Speaker 200:13:46J. Patel, our Chief Financial Officer. Speaker 300:13:49Thanks, Brendan. Today, I would like to cover our financial results for the Q3 of 2024. Before I begin, I want to note that my commentary will focus on sequential comparisons to the prior quarter. Comparisons to the prior year are less relevant given the acquisition of Spectrum and generic competition of INDOCIN that occurred in the prior year Q3. Also, I want to remind everyone that Rovidone is now our lead asset and brings with it the associated changes in margin, operating cost structure and cash flows that you are seeing in our results throughout this year. Speaker 300:14:26For the Q3 of 2024, our total product sales were $28,700,000 down slightly from $30,700,000 in the 2nd quarter, primarily due to Rovidone sales being offset by the expected decline in INDOCIN. Rovidone sales were $15,000,000 in the 3rd quarter compared to $15,100,000 in the 2nd quarter. The change was driven by continued volume growth offset by lower net pricing. We continue to hold about 1 third share in our served markets. Indicine sales were $5,700,000 in the 3rd quarter, down from $6,900,000 in the 2nd quarter, driven by lower net pricing as a result of generic competition. Speaker 300:15:15In terms of volume, we continue to target and hold an approximate market share split. Reported gross margin in the 3rd quarter improved to 74% compared to 71% in the 2nd quarter, primarily due to level of inventory step up amortization and write downs from prior quarter not repeating. Turning to operating expenses. SG and A expense was $16,700,000 in the 3rd quarter, decreased from $18,400,000 in the 2nd quarter. R and D expense in the 3rd quarter was relatively flat at approximately $1,000,000 On an adjusted basis, excluding stock compensation, D and A and change in fair value, adjusted operating expense was $16,400,000 in the 3rd quarter, down from $17,700,000 in the 2nd quarter. Speaker 300:16:14The decrease was primarily due to lower sales and marketing and other G and A costs, partially offset by net higher legal related charges. GAAP net income for the 3rd quarter was a loss of $2,900,000 down from a loss of $3,700,000 in the 2nd quarter. Because GAAP net income includes a number of non cash expenses, we also use adjusted EBITDA as a good indicator of the operating performance of core business. Q3 adjusted EBITDA was a positive $5,300,000 increased from $5,000,000 in the 2nd quarter due to lower operating expenses, partially offset by lower product sales. Please refer to our press release for detailed reconciliation of our adjusted EBITDA results. Speaker 300:17:09Crossing over to cash flow and our balance sheet. As a reminder, we invest cash into short term investments. Therefore, our reference to total cash position includes both cash and cash equivalents and short term investments. Total cash at the end of the quarter was $88,600,000 effectively flat to the $88,400,000 in the 2nd quarter and debt remained unchanged at $40,000,000 As we previously noted, quarterly operating cash flows will fluctuate due to timing of working capital in terms of cash receipts and payments due to shift in product mix from IndusInd to Ovidon. 3rd quarter operating cash flows were negligible and were impacted by timing of working capital from cash collection and lower product sales. Speaker 300:18:01Year to date, we have generated $15,000,000 in cash flows from operations. With that, we will open the floor to questions from our covering research analysts. Operator, please go ahead with the instructions. Operator00:18:18Thank Thank you. Our first question comes from the line of Thomas Flyton with Big Street Capital Markets. Please go ahead. Speaker 400:18:46Hey, good afternoon, guys. Congrats on the good quarter. A. J, you didn't mention anything about guidance. Any thoughts on that for us? Speaker 300:18:53Yes. Thanks for the question, Thomas. You're right. At this point, we would have liked to narrow the range, but we still see a flux in few key areas for the remainder of the year. Therefore, we're going to keep the remaining guidance range that's out there. Speaker 300:19:08Some of the areas we're continuing to focus on is first, focus of stabilizing the business as we cross over from INDOCENT to Rovidone. Secondly, as we continue to monitor the generic competitive landscape of INDOCENT. And then third is the dynamic pricing and volume activity occurring in the GCS market landscape. Speaker 400:19:32Great. And then as a follow-up or not a follow-up. Brendan, you had spoken in the last quarterly call and I think in some investor conferences about your desire to maybe do a smaller deal this year and then maybe something more transformative in 2025. Could you give us your updated thoughts on that? Speaker 200:19:50Yes. So we continue to look at the landscape of what's available and what's out there. And there are assets that we think we could execute whether they're smaller, whether they're larger. But the further we go, I'm starting to think maybe we do something a little bit more robust in the near term than there may be a small tuck in. So it really kind of depends on what's out there, what the price is, what we can get and how we think it fits with our model. Speaker 200:20:15So I'm optimistic. I think there's lots of doable deals out there. But I've said before, I want to make sure it's the right fit. So I don't want to jump into something just because we feel like we need to. I want to make sure that it's the right thing for Assertio and we're paying the right price for it. Speaker 400:20:35Excellent. Appreciate you taking the question. Speaker 200:20:37Thank you. Sure. Thanks. Operator00:20:41Your next question comes from the line of Nazaraman with Maxim Group. Please go ahead. Speaker 500:20:47Hi. Thanks for taking my question. They're both on rolling on. I'll start with this. In regards to pricing, where do you think the pricing decline sort of stable out? Speaker 500:20:58Do you think you've reached stable prices or do you think there's still room for the pricing that pricing to decline? Speaker 300:21:07Yes. Hey, Nas, this is A. J. Thanks for the question. I would say, the GCSF landscape is very competitive, especially with the biosimilars, and some of the more recent entrants in the last few years really driving pricing. Speaker 300:21:23Therefore, in this market we are somewhat hindered by what the market competitors will continue to do. We have seen pricing declines over the last few quarters, which we anticipate the trend would continue, as market share starts to equalize. But one of the things we're absolutely focused on is the market that we operate in from a Medicare Part B perspective and maintaining our, one of our leading market share position there. Speaker 500:21:53Got it. That was helpful. And my follow-up question is following the same day dosing data, could you talk a little bit about the logistics and potential timeline to get that into NCCN guidelines? Like what has to happen there and how long does that take? Speaker 200:22:09Yes. So thanks for the question. So again, we'll make the data public here in December. And then I think it is roughly about a 6 month window for us to work with MCCN for them to consider. That doesn't mean that it would be mid year, but I think the earliest it could potentially be is mid year. Speaker 200:22:30So we haven't had those Speaker 400:22:31discussions of those conversations yet, but I think it will be somewhere between the middle and Speaker 200:22:31the back of the conversations yet, but I think it will be somewhere between the middle and the back end of next year. Speaker 500:22:39Got it. Thanks for taking my questions. Speaker 200:22:42Sure. Operator00:22:44Thank you. Our next question comes from the line of Scott Henry with AGT. Please go ahead. Speaker 600:22:56Thank you and good afternoon. A couple of questions. First on rolvedon, Q1 roughly $14,500,000 2nd quarter $15,100,000 3rd quarter $15,000,000 guidance I assume is still in place of roughly $60,000,000 for 2024. So we've got about 4 quarters right around that $15,000,000 mark. Do you think it's basing out here for future growth? Speaker 600:23:28Or will maybe the growth be slower? Just trying to get your sense of there's a lot of moving parts here in that market of how we should think about growth for Rolvedon in 2025 and beyond. Speaker 200:23:44Yes. No, it's a great question. So thank you. And you're right, right. You've seen about 15,000,000 dollars Q1, Q2, Q3 has been relatively stable. Speaker 200:23:54And I think if you think about the year that roughly $16,000,000 in sales is right about where we think we'll be. But as we enter 2025, I mean in 2024, we've been very focused in the community oncology clinic space, as A. J. Said, focusing in the Medicare Part B space, where we maintain about a third of that market share. As we move into 2025, we do think that further growth is not only possible, but that's what we're planning for, as we expand beyond that clinic space into hospitals and so forth. Speaker 200:24:30So we are planning for growth and we're approaching this category and we're approaching rolvedon is a long term play. We're not looking for dramatic spike in any one particular quarter. We're looking at this asset over the long term. So we do think that we'll see continued growth and we have plans to drive continued growth with Volva. Speaker 600:24:54Okay, great. And SG and A in the quarter was on the it seemed pretty low, it's a good thing. Do you think that's a fair number to extrapolate going forward? Is that kind of the run rate you have currently? Speaker 300:25:13Yes, Scott. Good question. Yes, I would say generally in our business, the second half of the year from an SG and A is generally lower as a lot of our S and M initiatives occur in the first half of the year. With that, we also additionally had additional kind of restructuring and retransition we did with the company in the beginning in the Q1 of the year. So that kind of reflected a higher run rate. Speaker 300:25:38I would say the average of the last two quarters is sufficient for the remainder of the year. Speaker 600:25:45Okay, great. And the final question, I just wanted to ask on the Board update. Yes, I've covered the company for a while. I believe there was a retirement a mandatory retirement age for Board members. Was that a factor in Peter Staple retiring, if I recall that correctly? Speaker 600:26:10And if you could give any color on Doctor. Visserka retiring. I think he said something earlier, but I might have missed it. Speaker 200:26:20Yes, sure. No, I'd be happy to address both. So, I mean, Peter has been on the Board for 21 years. He's seen a lot of different versions of Assertio and I think has worked with 6, 7 or 8 CEOs. So, while I think Peter was approaching the term age or had approached it, I think there was a plan for Peter, to step back for a while and retire from the Board. Speaker 200:26:43He stayed on largely because there was the transition between the former CEO, Heather, becoming the Interim CEO to bring me on board. And then after I was on board, this transition between Peter and Heather was planned to take place. So this has been a while in the making. I think Peter has been phenomenal and he served Assertio well over the years. As I said in my opening comments, very calm demeanor, very experienced professional and really, really what I believe a great Board member and I appreciate his contributions. Speaker 200:27:21In regards to Doctor. Vaserca, Doctor. Vaserca came from Spectrum. He was on the Spectrum Board, I believe. And I think what Doctor. Speaker 200:27:30Vaserca did for Assertio was really help with that integration and provide continuity as we integrated Spectrum into Assertio and started to really understand the G CSF market and the oncology market in the oncology clinic space. So I don't think, and I don't want to speak for Doctor. Visserka, but I don't think it was ever his long term intention to stay on the Assertio Board forever. In fact, he probably, stayed longer than planned, but I think he's thinking that he has a lot of outside other business interests that he needs to pay attention to. So this is a good time for him to step back from the Board as well. Speaker 600:28:05Okay, great. Thank you for that color and thank you for taking the questions. Speaker 200:28:09Sure. Sure. Operator00:28:12Our next question comes from the line of Ram Selvaraju with H. C. Wainwright. Please go ahead. Speaker 700:28:20Thanks very much for taking my questions. I just wanted to ask 1st and foremost about what the underlying market dynamics are that you're seeing that are driving new customers to choose Rolledad. If you could comment on that in some additional granularity, please. Speaker 200:28:38Well, I'll just give you my take first and then A. J, if you want to jump in and say anything, you're welcome to. But look, I think that rolvedon is, competes as we said in a very dynamic market place. It competes with other 6 or 7 or 8 other GCSFs. And it depends upon the actual slice of the market that you're competing in. Speaker 200:28:59You know that we compete in the clinic Medicare Part B space. We've been successful there. I think physicians recognize and providers recognize that rolodon is a very safe and effective product. And I think that that will be underscored when we see the results of the same day dosing. Having said that, a lot of this is a contract play and a lot of it is about access and a lot of it is about do you have the right ASP formula, how are you managing ASP erosion, all of those things. Speaker 200:29:31So I think at the end of the day, a lot of times this comes to a contract play that is largely sometimes not even a physician that's making that choice. It might be a practice manager. So, patients may be unaware of the particular GCS that they're getting. Some may be aware, some may not be aware. But overall, it's decided kind of at the clinical level, a lot of times by decision makers that way. Speaker 200:29:57Ajay, anything else Speaker 300:29:58to add? No, I think Brendan hit it spot on, right? The former in terms of the appeal of the product itself helps us get kind of into the door. And then the second on the contracting side, has helped us with the stickiness of sustaining our leading market share in the oncology space. Speaker 700:30:15And then just as a follow-up, I just wanted to see if A. J, you wanted to comment on what you see as future trends on the gross margin front. If you think that sustainably maintaining gross margins in the sort of low to mid-70s is possible as the product and revenue mix evolves? Thanks. Speaker 300:30:34Yes. No, thanks for that question. Yes, I think as I mentioned to Thomas, right, I think we're keeping our previously announced guidance for 2024 in line. We're not ready yet to comment anything beyond kind of 24 here. So previously stated comments on gross margin that year over year there will be a gross margin erosion as we shift from IndusInd, which was a highly accretive gross margin product with very little commercial activity behind it to Lovidon, which is a biologic and carries a higher COGS rate and additionally has the commercial spend behind it. Speaker 300:31:11So we do continue to see that shift occurring into Q4 as well. But we are absolutely focused on from a pricing standpoint, maintaining that blended between 70% 75% gross margin rate for 2024. Speaker 700:31:34Thank you. Operator00:31:37As there are no further questions, that concludes the Q and A session. I would like to turn the conference back over to Brendan O'Grady for any closing remarks. Speaker 200:31:47Thank you. And I appreciate everyone who has joined us today. I just want to reiterate that I believe we have a great platform, an excellent team and a sound strategy, as well as a balance sheet that will help support further growth. I hope that today's call has continued to demonstrate our ability to deliver steady execution on the commercial business we have today, as well as our commitment to finding the right assets to further grow the platform. If you'd like to arrange a meeting or at an upcoming event or an update call with management, please contact Matt Kreps directly using his information provided in the press release and we'd be happy to schedule a time to speak. Speaker 200:32:28And thank you all again for joining us today. Operator00:32:33That concludes today's meeting. Thank you for your participation. You may now disconnect.Read morePowered by