Everybody for joining us at the Citizens JMP Life Sciences Conference. Excited to welcome Assertio Holdings next. Assertio is a pharma company with a portfolio of commercialized assets spanning from neurology, inflammation, pain. I'm probably forgetting another, but excited to introduce Ajay Patel, the company's CFO. So Ajay, welcome.
Thanks, Jason.
Well, thanks, everyone. Excited to be here. Thanks for giving us this opportunity to present here. Before we get started, our kind of standard disclaimers: I will be giving some forward-looking guidance here. I ask you to refer you to our most recently filed SEC filings for additional disclosures. So this is kind of a quick snapshot of Assertio, who we are, what our kind of business summary is today, some of the financial metrics around Assertio. Assertio overall is a commercially focused company. We have five primary assets on market right now that are all positive cash flow generating.
We like to pride ourselves in a lean, cost-efficient model that generates positive cash flows. For the year, we've given our 2024 guidance. We recently just announced our Q1 results, which provide that we're on track to our annual guidance.
We currently have about $80 million of cash on the balance sheet and $40 million of debt. In terms of our products, our primary products are Rolvedon, Sympazan, Otrexup, Sprix, and Indocin. We're really, from a commercial asset perspective, therapeutic agnostic. Rolvedon operates in the oncology space. Sympazan operates in the neurology space. And then rounded out is the Otrexup, Sprix, and Indocin, which primarily operate in kind of the pain inflammation space. So diving a little bit more into our assets here, our core growth assets we really kind of define as Rolvedon and Sympazan. Rolvedon is a recently acquired asset.
We bought Spectrum Pharmaceuticals. We closed the deal in mid-2023. That is an asset that was launched by Spectrum in Q4 of 2022. For fiscal 2024, Rolvedon will approximate 50% of our net sales, is expected to approximate 50% of our net sales.
The differentiation with Rolvedon is it's the first LA-G-CSF product launched in 20+ years that's not a biosimilar. So it's its own molecular compound structure. Sympazan is a product we acquired in 2023 from Aquestive. It is a clobazam oral film that's utilized for LGS seizures. The differentiation there is the oral film delivery mechanism, which is differentiated from just generic clobazam that's typically in the oral solution or the pill form. Both of these core growth assets are kind of the pillars for Assertio because of their IP protection on them.
Rolvedon and Sympazan have IP protection that takes us well into the next decade. Rounding out our portfolio is Otrexup and Sprix. Otrexup we had acquired in 2022. And Sprix and Indocin came through us via Zyla merger in 2020. Otrexup and Sympazan provide us our steady cash flow assets at nominal growth rates.
Our post-exclusivity assets are Indocin and Cambia. Indocin used to be our primary asset prior to it going generic in the middle of 2023. Focusing on Rolvedon a little bit more, it's an eflapegrastim injection that competes against Neulasta and the seven other biosimilars that are out in the market. However, because of its new formulation and it does have its unique J-code, and its J-code from a Medicare reimbursement is not tied to Neulasta or any other biosimilars. Therefore, it gives it its opportunity for us to ensure that we get to drive its ASP and the value that can provide to the clinics.
Additionally, we see the total addressable market there as an excess of $1 billion based on our internal estimates. That market is split roughly two-thirds hospitals and one-third community clinics. Through its launch, we've primarily focused on the community clinic side of the launch. So what we presented here is the Rolvedon demand, the pull-through volume since launch. We've been very satisfied with the pull-through volume on Rolvedon demand since launch. In the most recent quarter we just reported had the highest growth rate for Rolvedon since its first quarter of launch.
The other thing that I had highlighted for Assertio is its lean operating cost model. Where that really derives from is on the right side, our low-cost NPP platform. Coming out of COVID prior to the Spectrum acquisition, we were one of the first companies to go to a full digital model with no sales reps. That's comprised of all of the items here that could potentially provide value to HCPs from a detailing standpoint.
So we really focused on all of the digital promotion methods that are available, in addition, complementing it with VSRs and remote sampling. Additionally, with the Spectrum acquisition, we acquired their field force. We have optimized that field force in Q4 and Q1. We currently have about a 30-plus-person commercial team that consists not only of the sales reps that detail to the oncology community clinics, but also marketing and contract and market access individuals.
What we like to think of is this efficient omnichannel commercial platform provides a holistic approach to delivering the growth in our volumes. In terms of 2024, our priorities primarily consist of these three items. We're going to continue to focus on net sales growth for Rolvedon and Sympazan. We're going to continue to deliver profitable cash growth. We've delivered profitable cash growth for the last three years.
That's one of the North Stars of Assertio. Additionally, with the capacity we have on our balance sheet, we'd like to continue to diversify our asset portfolio into more durable assets. So that growth, the inorganic growth, is going to come through business acquisitions. As we think about business acquisitions, what are we focused on? It's really assets that can provide that are on commercial already and can provide synergies to our operating profile. Additionally, we like assets with patent life or exclusivity.
As you saw our growth assets with Rolvedon and Sympazan, those assets have potential for enhanced growth over a longer period of time. Additionally, as we are currently cash flow and profitable, we'd like to maintain that and continue to add through that. So we're looking at assets that can be accretive from a cash flow and growth profile immediately.
So a little bit into our Q1 results that we just reported here, we reported approximately $32 million in net product sales. It was a slight decline to the prior quarter. We've provided sequential comparisons here just because of the change in the company from last year, same period to this year. What we had was in the middle of last year, we acquired Spectrum. And Rolvedon is now our biggest asset, so that did not exist in Q1 of last year. Additionally, last year at this juncture, Indocin used to be our biggest asset. Indocin went generic in the middle of 2023.
Therefore, that's our post-exclusivity assets. So what you see from a decline perspective is a little bit of the decline in Indocin being replaced by Rolvedon. We expect that trend to continue, where Rolvedon growth will start surpassing the decline in Indocin. From an operating profile, we had very favorable results on a comparative sequential year. From an SG&A perspective, we were able to, as a result of all of the harmonization and optimization we've done since the Spectrum acquisition, we've been able to realize a significant amount of synergies, which has contributed to our Adjusted EBITDA and our operating cash flows, as you can see here.
We've seen our cash balance grow. That's what we continue to expect for the remainder of the year. From a full-year outlook, to give you a perspective on the Q1 results, we're expecting net sales to be between $110 million-$125 million. Of that, Rolvedon will comprise approximately $60 million. Indocin, which used to be our primary asset, now will comprise approximately $18 million-$25 million for this year. We are expecting Adjusted EBITDA of $20 million-$30 million.
We started the year with $70 million of a cash balance. We're expecting to end the year with approximately $90 million-$100 million in cash, which hopefully shows you the strong cash durability of the business. Additionally, with Rolvedon, with our new growth asset, we've also provided guidance that in the near term and the coming years, we do expect the potential for Rolvedon to exceed $100 million. So with that, I'd like to wrap up our presentation and thank everyone for participating. And I can take some questions here.
So thanks, Ajay. Maybe just take a step back through to the prior to the acquisition of Spectrum. What was it about the asset that, A, you thought was attractive, and, B, you thought you could do better with in your hands?
Yeah, good question. So one of the primary theses for the Spectrum acquisition was really diversification into patent portfolio. If you rewind the company back prior to the Spectrum acquisitions, our prior two acquisitions were Otrexup and Sympazan, also patent protected and differentiated products. So we do see the value and the growth potential there, that they provide durability and a little more stability and predictability. The reason for all three of acquisitions was diversification from Indocin. Indocin was an asset, when we acquired it, was probably doing $30 million-$40 million annually.
Right before it went generic, we had grown that asset to trailing 12 months of approximately $120 million. However, that's an indomethacin suppository. It's been on the market for 20+ years. It hasn't had patent or exclusivity in the last couple of decades. So we knew, as that asset continued to grow, it created an additional risk to the business in terms of a generic entrant. So essentially, what actually did transpire in a very short time frame is really the business risk we were trying to solve with the Spectrum acquisition.
What we really like about the product itself is that we've gone to a lean, low-cost operating commercial profile, and that although it was a new-launched product, it's not a new therapeutic area that requires a significant amount of investment from a commercial landscape. Because the therapeutic area already exists, it allows us to be able to piggyback off of that, but additionally just focus on promoting the differentiation that Rolvedon brings.
Great segue into my next question. Can you just kind of hit the highlights for us about the product profile, where you think the aspects of differentiation are, and essentially what your focus with your marketing messages are?
Yeah, yeah. From a Rolvedon, so the general marketplace is for oncology. It's utilized for patients the day after they receive chemotherapy or any sort of cancer treatment to help prevent neutropenia or reduce the risk of neutropenia. So from an eflapegrastim injection, from a delivery, it's no different than the Neulasta or the other biosimilars. So in the market space, it plays on par. From a differentiation, from its approval and what you can see from its guidelines, it did perform slightly better. But I think from an oncologist, it performs right on par.
Where you get the real benefit from an economic is the ASP with Medicare, with the way that reimbursement works and what's happened with the ASP profile of the current market. It's being driven down by the biosimilars and the intercompetitiveness that occurs between them. Because our ASP is not tied to those biosimilars, we're able to dictate our own pricing terms. So what we'd like to provide these community clinics is somewhat of a stability in making purchasing decisions.
With the degradation in the current marketplace on ASP, these clinics go from quarter to quarter really looking at, where does my investment dollars from a working capital make sense? However, what they don't get is the predictability of, will a competitor keep their ASP stabilized from a long-term perspective? And us being able to control that gives us an advantage, where we're able to work with these community clinics to show the differentiation of, hey, not only is our product on par with everyone else, but we're focused on managing the long-term utilization of this product.
So you're several quarters into your own experience with the product. What have you learned? What's been surprising positively and negatively? Or how have you adjusted your commercial efforts as you've learned through the process?
Yeah, absolutely. Good question. So we obviously did take one of the headwinds, in addition to Indocin going generic in last year, was we hit a headwind right out of the gate when we purchased Rolvedon and Spectrum acquisition. We had a down quarter from where Spectrum was performing. And that was primarily to what we had quoted on our Q3 earnings call, is that when we acquired it, we found the channel a little bit too heavy. Spectrum had really focused on selling into the channel rather than focusing on the sell-through, which is not uncommon in the launch phase.
However, there needed to be a calibration done. So I think that was probably one of our biggest learnings, is just the competitiveness that exists within the market space of the decision makers, how they're making the decision. The economic spread that I kind of talked about is fairly obvious from a purchasing favorability for a community clinic. However, not every clinic operates in the same manner. The decision makers are sometimes incentivized by working capital, sometimes they're incentivized from a low-cost perspective, sometimes they're incentivized from a margin perspective in the spread.
So it's going up against those different dynamics and showing them the value of Rolvedon. Additionally, we've loved the performance of our commercial organization, especially the last two quarters post the stabilization. Part of that has been ensuring that we're educating and partnering with the market on incentive programs. ASP erosion happens because of incentive programs that don't think long term. So us really focusing on that long-term perspective.
Got it.
Yeah, hi. I came from the Spectrum. So I also have a question on Rolvedon. So you said the $1 billion opportunity. What's the total market size? And what's the assumption? What's the percentage you will take from this market?
Yeah. So obviously, we're still in the early stages of our launch trajectory. We've now owned it just for a little over 2 quarters. It's been on the market just over a little over a year. So when we talk about $1 billion+, that's from a dollar standpoint. We're making an estimation based on the number of units. So we do see the number of units for EPAG injections slightly growing, but it's not at a significant growth curve. Like I said, the therapeutic area has been there in the marketplace since probably for the last 5-7 years. Our estimation comes from where ours and the peers' ASPs are and projected to be over the next year and utilizing that as a proxy to estimate what their net sales are outside of what's already publicly available.
From our market share, as I said, it's 2/3 hospitals, 1/3 clinics. We've operated just in the clinic space. And if you further break those clinics down from a payer profile, you get about a 30% Medicare perspective. You get commercial. And then you get a little bit of just cash and self-funding and Medicaid. We're focused right now from a promotion standpoint on really focusing on clinics and the Medicare space. So we've really touched just a small sliver of it. I think from an overall market perspective, we would say we're in the low single digits from a market penetration. So there's still ample opportunity for us to.
Do you plan to target hospital in the future or any to ramp up? Or it's too competitive, I mean, the space?
It's definitely a competitive landscape. I would say, no. Hospitals are not outside of; it's not an area that we're going to completely exclude. It's definitely an area you need to be a part of. One of the learnings we're gaining additionally from our day-to-day operation is just how clinics and hospitals carry a parity of all the products, actually. They're not exclusive to any one product. So in order to gain penetration into those doors, you do need to provide an ability for them to carry your product.
Where we are going to be very prudent is the type of contracting we do. Because we're going to be focused on managing this product from a long-term perspective and its value proposition, we do want to make sure the contracting is done in a prudent manner. Additionally, we're going to focus on hospitals. As you know, from a manufacturing standpoint, hospitals operate a lot in the 340B space now. From a manufacturer, that can be a little bit detrimental from a margin profile. We're really going to focus on hospitals that have a good balance of patient profile that we would like to target.
OK, great. Thanks. I don't want to pry. Just one final one. I came from Spectrum. We have a little CVR there. Doesn't look like CVR has any chance to hit there.
The CVR that came through as part of the acquisition?
Right.
It's based on 2024 and 2025 revenue run rates. Obviously, from a 2024 standpoint, you've seen our guidance. It'll be outside of that spread.
OK, thank you.
All right. Thank you.
I'm not sure I caught all of it. But I do think that you were able to grow Rolvedon significantly so far and to the $60 million. Why do you see that peak is around $100 million when you've made so much headway and there's so much space in front of you? Why not a higher peak?
Yeah, I think that guidance we're giving is kind of more a near-term of what we're seeing the potential to Rolvedon to be. So that's not meant to be kind of a lifetime. That's where it peaks out or anything like that. I think what we really wanted to frame for the market with guidance this year is because of some of the business pressures we incurred on Rolvedon right out of the gate, there was a resetting of the base of, hey, what is the near-term potential we're seeing on this product? As we continue to evolve our commercial strategies, as we look at other market penetration opportunities, as we see how the competitors operate, we hope to continue to kind of exceed that.
What is the priority for business development to continue to diversify? Or is this an execution story about sort of throwing up, I mean, where you're trading at valuation-wise, and you could just throw off cash flow, and you should do just fine? Or is there going to be another potentially risky swing at another BD deal?
I think, as we had said kind of in our.
Of a similar size, not a tuck-in or anything, but another real asset.
Yep. No. And I think that's, as we talked about kind of our 2024 priorities, we're focused on both of those points. Execution, absolutely. Execution on Rolvedon, execution on Sympazan, Otrexup, Indocin, which results in the cash flow. So that's absolutely our focus. Additionally, though, it's the inorganic growth that's going to come through the acquisition. That is a priority. And as we recently stated on our call, we do like to do an asset that will move the needle a little bit. We've done company mergers. We've done tuck-in acquisitions.
The level of effort as a virtual pharma company is about the same from an integration perspective. Obviously, what we're absolutely going to be focused on is finding the right deal. We want to continue to show a durable, a predictable, a little bit of a de-risked business. We're absolutely going to be managing the risk profile in an asset with the outlay that we would be making for that same asset.
All right. So obviously, you have a very differentiated business model being completely the omnichannel, completely virtual. Do you see any value in the future bringing back in-person sales reps either from a therapeutic category or a type of physician or practice? I mean, again, we don't expect you to build out a full field force team again. But is there a select group of people that could be valuable to have in person?
Yeah, no, absolutely. I think by no means do we say in-person promotion is not warranted. Especially in given circumstances, it's very well warranted. What we have here with Rolvedon and being a new launch asset, getting the notoriety, we would, as part of our BD, we'd love to have an asset that we buy that can fit into the bag with our current oncology detailing. That makes the synergies there a little more appetizing. With one asset, there's capacity, inherent capacity there. I think it's always going to be a we're always going to look at this.
And what we'd like to pride ourselves is we always focus on not just chasing every volume growth. We want to chase profitable volume growth. So where we're going to find the benefit is if we see the return on that dollar investment actually contributing from a margin profile.
So what we'd like to do is we'd like to look at it holistically, also from a payer contracting and a payer profile. Because sometimes you could get into a situation where a lot of that growth and a lot of that commercial profile is coming from a payer that ends up being detrimental to your margins. So that's how we look at our entire investment in those assets and the commercial activity.
Fantastic. Ajay, really appreciate you being here with us this afternoon.
All right. Thanks, guys.