Denny Lanfear: Thank you. Paul, do you want to comment a little bit about our expectations for CIMERLI going to 2025 with IRA?
Paul Reider: Sure, Denny. Thanks for your question, Mike. For 2025, formulary negotiations are ongoing. And CIMERLI and Coherus are actively engaged in that process. So we continue to believe that I think the point where we see even greater inflection of biosimilars coming out of adalimumab space. So I think we’re well-positioned there based on our price point and the value that this product brings to the healthcare systems and patients.
Michael Nedelcovych: Thank you.
Denny Lanfear: Thank you for your question.
Operator: [Operator Instructions] Your last question comes from the line of Balaji Prasad with Barclays. Your line is open.
Unidentified Analyst: Good afternoon. It’s Shaun [ph] on for Balaji. Thanks for taking our question. Just a quick follow-on question on the UDENYCA franchise, and you recently announced that the license in packages on boarding injector and pre-filled auto-injector, and they expect to submit the BLA [ph] in the first quarter of 2025. And there are a few other players that are trying to get into this landscape. So what is your expectation for the request from on-body injector landscape and the entire market for the next two to three years? And do you have any plans or mechanism to build and defend your market shares against those potential new entrants? Thank you.
Denny Lanfear: I’m sorry, I don’t understand, we’re having a difficult time hearing you. Want to understand your question. Is your question with respect to future entrants, in the on-body space with the like progesterone market or with auto-injectors?
Unidentified Analyst: Progesterone market, especially the on-body injector and the auto field – pre-filled auto injector as Amneal recently announced that they have something in plan and they plan to sell BLA in first quarter of 2025?
Denny Lanfear: Paul, would you like to address how we view the competition in regress to market for future auto injectors?
Paul Reider: Yeah. Well, first of all, we’ve been operating in this pegfilgrastim market now. We’re in our sixth year and maintain one of the leadership positions here. So what we’re going to continue to do is focus on our business and the positioning of UDENYCA, which is to be the total solution for providers and patients. And we’re doing this, as I mentioned, because today, we’ve got all three presentations. It’s tried and true and well established in the market. Secondly, we’ve got strong payer coverage. And so that’s being recognized by payers. UDENYCA brand is a go-to brand because of all of these benefits that we bring to not only the consistency in the marketplace to predictability but also the high quality and reliability of this brand. So we’ll be prepared for any competition if anybody else comes, but we believe we’ll continue to be well-positioned to compete and win whenever that landscape unfolds.
Denny Lanfear: Thank you, Paul. The other point that I would make is consistent with Paul’s remarks, our on-body injector represents an innovative de novo highly sophisticated device with a 5-minute injection time. and the enthusiasm with which it has been received by the market, the physicians and the patients is due to that. We believe there are significant technical hurdles to such an approach and we investigated a number of approaches before settling on this one. So we think this is very important. We think we got it right. But lastly, as Paul said, we are first competitors in the pegfilgrastim market and our track record over the last six years demonstrates that. We are the only team with all three presentations, each filling of particular need in the market. So I believe that we’re very confident in our ability to compete and remain successful and grow share in this market.
Unidentified Analyst: Thank you.
Operator: Another question comes from the line of Douglas Tsao with H.C. Wainwright. Your line is open.
Douglas Tsao: Good afternoon and thanks for taking my question and congrats on the progress. Obviously, there are a number of sort of dates that you need to clear in terms of the ramp-up for LOQTORZI in particular, getting onto formulary. How quickly do you think you can get through those and sort of have access at sort of the most of the majority of the market? And what other steps do you think we might need to — you might need to clear before we really start to see an acceleration in the revenue trajectory?
Denny Lanfear: Thanks for your question, Doug. Paul, would you like to comment a little bit on the gating of the adoption of LOQTORZI and how we do that?
Paul Reider : Yes. Thanks for your question, Doug. Yes. So obviously, the payer coverage was — is the first one, and that’s well established. And I don’t really foresee any further hurdles on the payer side. The second gate is now that we’ve got the NCCN guidelines, what we have to ensure now is in each of the accounts that the guidelines that are translated into the order sets so again this enables the doctor at the time of prescribing — when they click through the order set that — LOQTORZI chemo combination is there, that’s ongoing, but that will typically settle in here over this next quarter. Then, Doug, I really think the next gate is just sort of washing out all of the current patients that are on current off-label PD-1s and establishing the new patients with LOQTORZI as the new start and getting anybody that on chemo today or not on a PD-1 treated with LOQTORZI.
And that’s just going to take a continued effort in terms of promotion, both through our sales team, from the KOLs from the podium and through the referral networks, but also through our digital efforts. And we’re going to continue to invest and deploy those so that at the time of decision, the oncologist knows that LOQTORZI and chemo is the regimen of choice for those patients. But again, it’s a rare disease. It’s going to ramp up, which is why we think peak is going to occur around year 3 of this, but we feel very confident we’re going to achieve that.
Dennis Lanfear: So for all the reasons that Paul just elucidated, we see the growth of this market as a steady ramp up to peak market share and penetration probably out around year 3, so this is in a market and such as a replacement enzyme market or something where you can get out to these patients and just find them immediately convert them. These patients are in various stages of therapy. They may have been exposed to another PD-1. We’re going to catch the patients that had ring chemotherapy. Those are eligible. They all benefit. Some patients, we will have to wait for them to progress to second line, but the key issue is, as Rosh Dias pointed out, we are the only first-line therapy from the FDA. We’ve gotten a position on all of the formularies. We’re doing very, very well with the NCCM, but I would say with the building blocks are in place for the market, we see a steady ramp forward in the future.
