Rosh Dias: And maybe one last thing I’ll add, safety is always important. We showed a very — it’s a very clean safety profile as well.
Theresa LaVallee: Very important.
Yigal Nochomovitz : Okay. Can I another one. I was curious on one on CH-114. Theresa, you mentioned the dose escalation and then you’re going to do the comboatory. I think in your slide deck in early January, you indicated there’d be some data in the first half of the year for the Phase 1. I wasn’t sure if that was still the expectation? Or just help understand that, please?
Theresa LaVallee: Yes. We plan to present the dose escalation in the first half of the year at a major medical conference.
Operator: Our next question comes from Colleen Kusy with Baird.
Colleen Kusy: I think revenue guidance is something you’ve given in the past. It looks like you’re not providing revenue guidance for 2024. So can you just talk a little bit about that decision and what you think some of the levers are for revenue growth this year?
Dennis Lanfear: Thanks, Colleen. I’ll take that one and let Paul backfill. I think the primary issue is that we have freshly launched the UDENYCA on-body. We’re very excited about the enthusiasm that’s been received in the market. But the ultimate trajectory of that across 2024, it is not yet known. It’s only been out of the market for about a month. As Paul pointed out though, we have seen a 129% increase with respect to the auto-injector uptake. And the trailing 4-week data for UDENYCA itself is north of 25%, up from Q4. So that’s a very, very compelling. I think that would give us greater certainty with respect to the trajectory and the steepness of the trajectory. Once we get a little further into Q1 and get that below us, all the indicators are positive.
But I think certainly on the next call, we’ll be able to give you some additional information on that. With respect to LOQTORZI, as Paul indicated, we’re very pleased with the launch. Our digital strategy over the last two years of basically developing a relationship with the patient is very, very good. We are very pleased with the uptake, very pleased that P&T committees and how well we’re doing there. But I think that’s going to take a little bit of time. It takes a month or two to get on a familiar for a P&T committee in a major hospital in some place, the East Coast or something. So we’re happy to do that, but we just would like look probably another quarter under our belts before we go ahead and we do projections with respect to revenue.
But on the topic of revenue though, I will make one key point for you is the quality of the revenues is just as important, if not more important, as the size of the revenues. And we expect that the margin and the qualitt of revenues, for example, with LOQTORZI and UDENYCA will lead to greater profitability as we go into the back side of the year. And as Paul said, that’s really where we’re focused. We want to drive the top line, but we also really — the quality of the revenues, especially with the product like LOQTORZI, it is going to be far better, more stable and more sustainable than your typical biosimilar.
Colleen Kusy: That’s helpful. And maybe a follow-up on the comments and just a quick clarification on cash flow positivity. I think you said the goal is cash flow positive in 2024. Can you just clarify, is that guidance for cash flow positively in 2024 or not specifically, maybe dependent on revenue or other factors?
Dennis Lanfear: Without being able to predict revenues, I can’t really predict cash flow positivity. But I would just make the key point that I think that we’ve made substantial progress with respect to reducing our SG&A and R&D line, even in the face of several launches over the past 12 months. We have reduced our head count over the past three years from ‘22 to ’23 to ’24 from 360 to 290 and now targeting 215 FTEs by the end of this year. I mentioned our overall SG&A reductions. So I think that we are running a very, very efficient organization as we focus on oncology. At the same time, we’re driving the revenues higher, as you can see. And then lastly, we’re making very good progress reducing our interest cost. Bryan recapitulated that for us, but a 70% reduction in our fixed term loan interest costs where we’re paying SOFR plus 8, I think that’s really very significant.
So we’re going to continue in this direction. And just where those two lines cross, we can’t quite predict but that’s our north star and our guiding light and where we’re going.
Operator: Our next question comes from Michael Nedelcovych with TD Cowen.
Michael Nedelcovych: Thanks for the question. You have a wealth of opportunities in terms of various combinations in various tumor types and indications where those combinations might be tested. Can you give us a sense of pipeline priorities and when those priorities might translate into discrete go/no-go trials or even pivotal trials?
Dennis Lanfear: Thanks for the question, Michael. I’ll let Dr. Lavallee address that. Theresa?
Theresa LaVallee: Yes. Michael, thanks. We as we’ve talked about with casdozo, the lung cancer study is open. I mean that’s a home run kind of strategy, a high bar, but given the monotherapy activity of casdozo, which was not expected to see in cancer patients. The LOQTORZI combination should show data by the end of this year or early next year. We’re all looking at earlier lines of treatment based off of the LOQTORZI data trials such as NEOTORCH to further explore lung cancer, the HCC study, we plan to open later this year, so data next year. As we mentioned, the 114, the CCR8 antibody will be presenting in next quarter. So I think the news flow from that plus a number of partnerships. We’ve already announced the INOVIO one, you’ll see other ones, and that will be generating data next year, so also being presented.
