Joseph Thome: Great, and then maybe just a commercial question. What’s sort of the average length of time a patient is on Cosela in the real world, and as some of these new accounts are coming on in the fourth quarter, are you seeing them being used in different patients, so that sort of overall usage timeline could potentially expand in the years to come? How are you thinking about average use?
Andrew Perry: Yes, thanks. As you know, in the first line setting, you would expect around four cycles on 21-day cycles, and on average we see probably around about 3.3 to 3.5 cycles. Sometimes that’s due to patients starting in the second cycle or the third cycle, sometimes it’s also due to patients being initiated in an in-patient setting where they’ll only receive one cycle and are then being discharged to the community, where they’ll receive the subsequent cycles, and of course our analysis doesn’t always pick up on that. When people use Cosela in that setting, they do tend to use it for every cycle.
Joseph Thome: Great, thank you very much.
Jack Bailey: Thanks Joe.
Operator: Thank you. Our next question comes from the line of Dane Leone with Raymond James.
Dane Leone: Hi, thanks for taking the questions, and congratulations on the progress. Your commentary around the start to the year for Cosela uptake was obviously highly encouraging with the financial guidance, but can you just take us through what you think has catalyzed the expanded use and adoption of Cosela? Obviously for the orders in 2022, sales were relatively flat, but it seems like you’ve been able to invigorate some growth there, so anything you can elucidate in terms of what’s driving that, I think would be super helpful. Thank you.
Andrew Perry: Yes, thanks. Obviously we had great success in Q2 and we saw 60% volume growth within the quarter of Q2. Much of that was driven by the addition of new accounts and new patients. We were not as successful in driving new accounts and new patients in Q3 – we only added 70 in Q3 compared with over 100 in Q2. Q4, we were back to strength, adding new accounts in Q4 and new patients in Q4, and that’s really been the driver because as those new accounts come onboard, some of that new account business then goes into Q1 of 2023, so it gave us a much better exit path into the next quarter. The reasons for that, so we’ve focused very much on pull-through in the community and on improving our ability to execute within community clinics.
We’ve discovered that the reasons for that are improved access, the opportunity for standardized EMRs I referred to earlier, obviously the successful of our contracts and the potential for more of that, and the economic value proposition that Cosela has had ever since launch, which is very appealing in the community setting. Some of those community organizations, as they come onboard, they can range from five, six, 10 individual accounts, sometimes 80 to 100 individual accounts within one organization, and as you see trial and then the physicians prescribing the products seeing the benefits of the product, wanting to communicate that through peer-to-peer, you can see a very rapid adoption throughout the rest of our community oncology network.
That’s definitely been our sweet spot for execution in Q4 – we’ve doubled down there and we’ve seen that success continue in Q1.
Dane Leone: Great, thank you. Maybe another follow-up question for me, can you just contextualize what the scale and scope of the data from the Phase II study with sacituzumab govetican will be in the second quarter? I guess number of patients and median duration of follow-up would be super helpful for people to set expectations. Thank you.
Raj Malik: Yes, hey Dane, this is Raj. We’ll provide of course updated safety data and data on all the patients. As I said, we’re completing the enrollment, we expect approximately 30 patients’ worth of data at the time. Enrollment’s been going on for longer than a year, about a year and two or three months, so I couldn’t tell you what the median duration of follow-up would be at the time of the presentation, but obviously it would be long enough for us to make a call on at least preliminary PFS. I think the other point is since tumor PD-L1 status is an important consideration and we are also evaluating the immune hypothesis for trila, that will be another important aspect of the mechanism that we will be also currently evaluating and then presenting.
Dane Leone: Thank you, and sorry – one last one from me. A good question I think we’re getting as it relates to some of that earlier question, does PRESERVE 2 actually have a futility analysis on OS designed into the study that could be evaluated before the readout in the first half of ’24? I think people are asking that question within the context of understanding what the actual hazard ratio needs to be on OS as an end point and whether it would be prudent to maybe look at it interim and see if there could be futility in continuing the study. Thank you.
Raj Malik: Yes Dane, we did not include a futility analysis. It was really an interim for improvement in efficacy, and primarily because of the signal we saw from our Phase II study. Obviously the other comment I’d make is the data monitoring committee reviews the data regularly, so if they feel like they need to run a futility analysis, they could of course do that on their own as well.
Dane Leone: Okay, thank you.
Raj Malik: Sure.
Operator: Thank you. As a reminder, to ask a question, please press star-one-one on your telephone. One moment, please. Our next question comes from the line of Priyanka Grover with JP Morgan.
Priyanka Grover: Hi everyone, this is Priyanka on for Anupam Rama. We just had a quick question. What exactly–or could you provide some color what’s driving the delta between the 2023 guidance of $50 million to $60 million on metrics, is it just penetration or is there some seasonality, like in the third quarter in SCLC? Thank you.
