That's a little bit about my background, up until I joined Assertio, four months ago.
Yeah. Now, you've been at Assertio, like you said-
Yep
Since basically June. Now, with this much time under your belt, which I understand is a very limited amount of time, strategically, what have you seen in Assertio that you like, and what are things you might wanna change or do or adopt going forward?
Yeah, so quite a change, right? When I came from Teva, we had over 600 assets and a $9 billion portfolio. Glenmark, we had 400 assets. I come to Assertio, we have 7, right? And 4 or 5 maybe that we're really focused on. So I think the clarity of what we need to do as an organization for me is crystal clear, and I'm sure we're gonna talk about that. And I mean, it's really about optimizing the assets that we have. It's getting growth out of 1 or 2. You mentioned this transformative ... I call it the transitional year, right? Where we're moving from Indocin as our biggest product that lost exclusivity a little over a year ago. Right before that, we launched Rolvedon.
We're transitioning from Indocin as our main asset to Rolvedon as our growth asset. There's some differences in those products, and then it's really kinda optimizing the rest of the portfolio while we look for the next big thing.
Gotcha, and just, like, starting on Rolvedon, so Rolvedon obviously can compete and essentially the Neulasta and the biosimilar Neulasta market. How do you differentiate Rolvedon from other products, including promotionally?
I mean, Rolvedon was approved under a BLA. It is not a biosimilar Neulasta. It's eflapegrastim, where Neulasta is pegfilgrastim, right? The molecule is slightly different. We don't spend a lot of time talking about that clinically just because most physicians will look at the two, and they look at them basically as interchangeable. Even though we are a BLA and we have our own IP, we do, in all reality, compete in a biosimilar marketplace. We do, you know, talk about Rolvedon in the construct that it is, but we also... You know, it, it's very much a clinic or a contracting-type play.
It's not so much we're going in and talking to a physician and convincing them to use a pegfilgrastim or eflapegrastim. It is much more about, you know, "Use ours versus somebody else, and here's the reason that you should.
Got it, and just on that point, so on the reimbursement front, could you talk a little about what the current reimbursement paradigm is for Rolvedon, and what you sort of plan on strategically doing with that going forward in terms of either expanding reimbursement or improving reimbursement and coverage?
Yeah, I mean, as we think about Rolvedon, we have, and there's different ways you can go, right? There's only so much value you can give up, but everywhere along the chain, somebody wants a rebate, a discount, or some value. So we've kind of gone out to the market with this predictability and sustainability for Rolvedon. So we're looking at maximizing the value of Rolvedon over a period of several or more years and making sure that all the stakeholders get some value for the product. And I'll give you an example.
As opposed to going to the market and giving deep discounts to get a huge amount of volume across the market and see sales in the $120 million range, and the next year they crash to $50, and the next year you're out of the market because you've destroyed ASP-
Right
we're looking at trying to kind of maximize that ASP erosion time, so we can continue to provide value. So you're gonna see, you know, growth this year. I think we've given guidance out around the $60 million range, give or take, and then we hope to see, you know, growth in the 10%-15% range after that and trying to maximize this asset for the long term.
Right. Rolvedon, do you commercialize in the 340B market for Rolvedon?
340B with few through the hospitals.
Right
A nd yeah, we are entering the hospital space right now. We don't have a lot of 340B business. We don't have a lot of hospital business. The vast majority of our business to date is the community oncology clinics. That's where we have really done a good job of penetrating the market. We kind of bounce between 31% and 35% share. We're about an average of 33 share in that segment of the marketplace-
Right
W hich is the Part B marketplace.
Understood. Going forward, do you wanna better penetrate that hospital market and move away from the clinic, or I guess diversify away from the community clinics, or do you wanna better penetrate the community clinics going forward?
I think the answer is both.
Mm-hmm.
I think, I mean, you know, again, today we're at a 33 share. How much share are you really gonna get in the community clinics?
Right.
Can we get 35? Can we get 40? Maybe. But at some point you're gonna cap out just with the number of competitors that you have in that space. So I think, you know, we're gonna certainly stay with community oncology. They're a very important customer segment to us. They've been great to work with to this point, but I think to really get the optimal value out of Rolvedon, we're gonna have to expand beyond that. We're gonna have to expand into the hospital market, which means we will get some 340B business, and we're probably going to have to go to payers a little bit as well and try to expand our payer coverage. We do have some payer coverage in the commercial market, but probably not as much as we need to really optimize Rolvedon.
Right, so when you speak to your KOLs or physicians or prescribing-
Yeah.
P hysicians, what kind of feedback have you gotten for Rolvedon as to why they are or are not writing Rolvedon versus any of the, you know, the last biosimilars? Once again, acknowledging those are essentially sort of different compounds.
Yeah, well, I think it comes down to a purchasing decision, to be honest. I think that you know, when you go to the big community oncology practices or clinics, you know, they're making an economic decision. They assume that they've seen the science on Rolvedon. They know that it works. Of course, they know Neulasta, and they know all the biosimilars. They know that they work. So it comes down to what product can they use for what patients, where do the majority of their patients come from, you know, what are the economics for them? And it's a buy-and-bill market, right? So if they're buying it at X price, what are they getting reimbursed for, so they're positive, or are they getting reimbursed for their negative?
'Cause in some situations, you can administer a product to a patient, and you lose money because the reimbursement is less than you bought the product for. So I think it's very much an economic decision for physicians, based on the patient and what their coverage is, versus a clinical decision. 'Cause the clinical, they see these pretty much as all interchangeable.
Right, so I guess on that point, what's been, what has it been like managing that overlap or potential overlap of reimbursement versus different community clinics in different centers? Because, like, have you found situations where, like, some community centers are like, "Okay, we're going to buy Rolvedon, we like the product"-
Yep.
But then you find out later, like, yeah, you're not getting reimbursed for this. How's it been managing all that?
I think it's a quarter-to-quarter, it's a quarter-to-quarter strategy, and you're managing your customers on a quarterly basis. Because you're right, you can say, "Okay, we like the product Rolvedon. You know, we like the, you know, the. It's a high-quality syringe, it's got a nice needle," and all that stuff, "and we don't have any issues, like, giving the product. The economics are good for us, and then the next quarter, somebody comes in, and they beat your economics, or it might be covered under this payer, you're not covered under this payer, but generally, in Part B, it's pretty. It's a pretty open space. Part B, we tend to do quite well, and that's really where our strength has been, but that's only a piece of the market.
We need more than Medicare Part B patients to ultimately get the value out of Rolvedon that we want to get.
Geographically, are you finding that the reimbursement is consistent across the United States? Or are you finding, like, various geographic territories or silos where you just get better reimbursement right now?
I think with in the Medicare space, it's pretty much the same across the U.S. I think when you get to commercial payers, it can differ by geography. Because, you know, obviously, whether it's, if it's Cigna or Aetna or United, they have different pockets where they have more share. And of course, when you get to the Blue Cross and Blue Shields, they obviously have different market shares in different places. So it kind of depends.
Got it. For Rolvedon, you're also conducting a same-day dosing study. I guess, for the audience that aren't familiar, could you talk a little bit about the study design and what you're sort of looking for in that study?
Yeah, so it's not a big study, but it is a study that was basically looking at and for those who don't kind of understand the marketplace, after you get chemotherapy, typically what happens is you'll see patients come back the next day to get a pegfilgrastim or eflapegrastim, which boosts white blood cell count because one of the effects of chemotherapy, obviously, it hits your immune system, and if you don't get one of these products, then what can happen is you get febrile neutropenia, which is you get a fever, and you get admitted to the hospital and before these products existed, there was a pretty high mortality rate from that fever so they've started giving chemotherapy patients these products the day after, and some patients, you'll see them wearing it on body.
Mm-hmm.
But it's a hassle because the patient gets their chemotherapy, they go home, they're not feeling well the next day, and then they have to come back to the clinic and get another injection, and then go back home again. So the theory is, and the desire is, if I can give the chemotherapy and give them the injection of Rolvedon or one of the biosimilars, and then send them home, they don't have to come back, and everything's good. So the study was designed to look at that. We have completed the study, and an abstract will be released and available before the end of the year to be presented at an upcoming oncology conference.
Right, you said this is a small study, so is this data something you could file sNDA with, or is this something you would submit to NCCN or something else?
It's not a study that we'll submit to as an sNDA for a change in the indication.
Mm-hmm.
I do think that, you know, hopefully, we'll be able to submit this for the NCCN to look at and, you know, get the guideline, get something mentioned in our guidelines around same-day dosing for Rolvedon. That would be probably the optimal case out of the study. Like, the stock being at $1.12 today? No, I don't. I think we're undervalued, and I think the likelihood of our stock going from $1 to $2 is much better from going from $1 is much higher than going from $1 to $0. So I'm bullish about Assertio. I think we have a good team. I think we have a good model. I think we've got a healthy balance sheet.
We have some cash to go out and do a deal, so it's all about finding the right deal, and we will.
Sort of on that point, you brought up the cash and share price. I mean, you've been looking at potential transactions for a little while or however much now.
I've been looking at it for four months.
Yeah, but I mean, like, the company as a whole.
Sure.
I guess, like, how's your thought about the utilization of cash, debt, and equity change for a transaction as you sort of progress through these conversations with potential sellers?
Yeah, so debt's expensive right now, as we know.
Mm-hmm.
So, debt isn't probably the most preferred, and equity is certainly, or equity isn't the price for that.
Right
B ecomes the most preferred option either. Now, if we had the right deal where equity needed to play a part of that, I think we would go to our shareholders and tell them why this makes sense, right? And get their buy-in. But we do have a decent amount of cash. We've got somewhere between $85 million and $90 million of cash on our balance sheet right now. I think we'll probably end the year at $90 million , right around $90 million. And we can deploy a decent amount of that to do a deal. And of course, the way you can always be creative the way you structure things, in the amount that you pay up front versus the amount you pay in milestones as you move along [crosstalk].
Royalties, right
And royalties and so forth, and those become kind of self-paying if you're hitting your goals and you do your deal model right. So, I do think there's things that we can do, using our cash, and we can be creative on how we structure it.
Right. All right, Brendan, I feel we can keep going and talk for a while, but we're unfortunately coming up on time.
Sure.
Is there any closing remarks you want to make or any takeaways you want to leave for, our audience here?
No, so my only closing remarks would be, first of all, thank you for having me.
For sure.
It was a pleasure. I really appreciate the opportunity. I joined Assertio because I believed in the company. I believe in the company. I think the model's a good one, and I look forward to seeing Assertio. Maybe we'll have this conversation again a year from now-
At a turnaround point.
And the stock will be, like, $2 or $2.25, and, you know, we'll be a $200 million+ company, so I look forward to seeing that.
All right, for sure. We'll be glad to have you back anytime. For the audience, if you want to have a one-on-one or have any questions or want a meeting set up with Brendan or Assertio, feel free to reach out to your Maxim sales representative, and we'll try our best to contact you. Thanks for joining our conference, and have a good one, everybody.
Thank you.
Jordan, are we good?