Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI) Q4 2022 Earnings Call Transcript

Thomas Riga: Yes, great question. I think one is timing. So that is very real. PNT is real. I think there’s other practical strategic challenges that one faces. We are never going to be the least cost alternative. And then there are hospital systems that a principal driver of decisions is least cost alternative. I think those are going to be a challenge. I think there are also a segment of hospitals, both 340B and non that are more value centric in their approach. Given the consolidation of many of the community clinics that have been have become hospitals over the years I think that thinking has infiltrated many of the large IDN systems. So I think the initial uptake in the hospital segment, certainly today is about timing. But I don’t think we have delusions of grandeur of the challenge that we’re going to face in that segment. And we’re going to be strategic in how we engage.

Prakhar Agarwal: Thank you

Operator: One moment. And our next question will come from Suhel Kazmi of . Your line is open.

Unidentified Analyst: Hi, good morning. This is asking a couple of questions from my end. So congrats on the quarter team, and I think a bunch of our questions have been addressed. But just curious on the same day dosing study, if you could provide us an update on enrollment and when we might hear some data from the study both either from the earlier expansion phase. I know this is open label, so any color you have from the initial would be great.

Thomas Riga: Yes, thanks for the question. We’re optimistic about this one. That study is up in running. We have a pre-specified interim review of safety and efficacy that’s that’s projected on the back half of this year. As you mentioned, we did do the expansion into the 30 minute only arm, so I think both the data and the practical realities of utilization fit that particular delivery mechanism. So 30 minutes post chemotherapy is the arm that we’re expanding. We’re expecting to have some visibility into that open label study in the second half of the year, and I think that’s going to largely inform if the product is performing in line with what we presented in Miami initially, and then the early data that was presented on what we believe the healthy drug could perform, so second half of the year.

Unidentified Analyst: Very helpful. Thank you. Maybe as a brief follow up, assuming we see some positive data here, can you talk about the impact across the different distribution channels be it the community oncology setting or the 340B, non-340B hospitals.

Thomas Riga: I think the first thing if your question specific has been the dosing, I think depending on the outcome, we would have more conviction on a path, whether that be going to chat with FDA about a regulatory path forward, whether it’s publication, it’s really contingent upon what we see in that data. So I think as it relates to distribution, commercialization today. we are focused and really pleased with what we’re seeing with what we have in the bag, and that is our non-inferiority label, given 24 hours post chemo. So I think here in the near term, we are executing that strategy. and that strategy alone, and then once we have visibility to the performance in the back half of the year, we could make a decision on what the appropriate next step of that strategy would be, and should the data be overwhelmingly positive, we would be aggressive in our approach, should it be underwhelming, we obviously take action there too.