bluebird bio, Inc. (NASDAQ:BLUE) Q3 2023 Earnings Call Transcript

Eric Joseph: Great. Good morning. Thanks for taking the questions. I guess just been thinking about or at least helping us frame expectations for a lovo-cel launch curve next year. Can you just talk a bit about sort of the capacity at — or the expected capacity at Qualified Treatment Centers in terms of bed capacity, beds reserved for patients looking to undergo treatment? And then, from a sort of pricing and reimbursement perspective, just looking for a little more color on these outcomes-based agreements. What outcomes, in particular, are going to be tracked for success? And then, sort of, where — how, I guess, a negative outcomes sort of might get reflected, ultimately in — on the top-line, whether that’s in the form of a sort of repayments or, ultimately, you’re kind of looking at protracted revenue recognition pattern? Thank you.

Andrew Obenshain: Hi, Eric. So, three questions in there. Number one, bed capacity at hospitals? Number two, what kind of metrics you’re going to measure outcomes-based agreements if there’s one for a lovo-cel? Then number three, if that’s the case, how that gets reflected in the financials? So, let me hand those first two to Tom and then the third to Chris.

Tom Klima: Yeah. Hi, good morning, Eric. So, capacity at Qualified Treatment Centers has not been an issue, and we don’t anticipate it being an issue going forward. Part of that is many of these hospitals have built out huge cell and gene therapy wings and big capabilities. Also, because our diseases are not acute, hospitals and patients have the luxury and have the convenience of being able to schedule around life event and schedule around busier times or less busy times at the hospital. So, so far, we have not seen capacity at a QTC be an issue. Number two, you asked a little bit about price and then outcomes-based agreements. Obviously, those go hand in hand. We will be talking more about price as we get closer to launch.

Outcomes-based agreements, I’m not going to give the specific endpoint right now for competitive reasons, but we did take into consideration, obviously, a different disease state with sickle cell disease, different primary endpoints, and then a higher Medicaid population. And what I will say is that we’ve received very positive feedback from payers. In fact, we’re close right now to signing with a few large national payers around our outcomes-based agreement, which we feel reflects how it’s being received and the positive momentum that we have.

Chris Krawtschuk: Great. Perfect. And then just capping off on that, the way that we’ll recognize revenue and constrain the revenue associated with any of the rebates that we’ll offer is we effectively estimate the number of patients that are coming through that particular class of trade and then constrain the revenue commensurate with that rebate that are being offered. Particularly like in Medicaid, you’d constrain it by 23.1%, if that’s the statutory rebate for that particular product. Remember, SKYSONA is 17.1%. So, we’d estimate that. And then, as it relates to the amount of estimated revenue coming through the outcomes-based agreement, we take a conservative approach here because of the accounting standards require us to ensure there’s no significant reversal of revenue.

So, we’ll estimate the outcomes-based agreement, the number of patients coming through that in conjunction with Tom’s market analysis, and then we’ll constrain the revenue accordingly and periodically look at the markers associated with that outcome-based agreement and release the revenue accordingly based on the contractual terms.

Eric Joseph: Okay. Great. I appreciate the color. Thanks for taking the questions.

Operator: Thank you. Our next question or comment comes from the line of Jack Allen from Baird. Mr. Allen, your line is now open.

Jack Allen: Great. Thanks for taking the questions, and congratulations to the team on the progress. A lot of discussion about the commercial dynamics around sickle cell and [indiscernible]. So, one of the questions I had was, how are you looking to leverage your long-term follow-up as you look to commercialize medication? Do you have any thoughts on the ability to get that into the label? And how you see that shaping up?

Andrew Obenshain: Yeah, go ahead, Tom.

Tom Klima: Yeah. Hey, Jack, good morning. Obviously, as we’ve looked back over the last many years in the market research and been out there in the QTCs recently, the amount of long-term data that we have in the most robust package of any gene therapy and sickle cell disease is a big difference when you talk to a thought leader, you talk to a prescribing physician, both either a referring community physician or a transplanter. So, we obviously will continue to leverage the amount of long-term follow-up that we have and that will continue to be an advantage for us.

Andrew Obenshain: Yeah. And I would just say a lot of times you see just a point in time efficacy. In this particular case, we will be publishing all this long-term follow-up, so it’s a much more robust picture of the overall profile of the product, which will be important in differentiating the product in the market.

Jack Allen: Got it.

Andrew Obenshain: Next question?

Operator: Thank you. Our next question or comment comes from the line of Gena Wang from Barclays. [Mr. Wang] (ph), your line is open.

Gena Wang: I have, I think, three quick questions. The first question is regarding this quarter the product revenue, $12.3 million, could you give a little bit more color to break down regarding ZYNTEGLO and the SKYSONA revenue? And then my second question is regarding the Lonza amendment, increase the manufacturing capacity. So, what is — how much [increase] (ph) that is? And what is the extended capacity in terms of the patient numbers? And then, lastly, regarding the outcome-based Medicaid — outcome-based for ZYNTEGLO, just wanted to have a clarification. For the revenue recognized or released, were you also proactively taking into account of a possible outcome failure, say like a 10% discount, for your revenue recognition?

Andrew Obenshain: Yeah. Okay, great. I will — I’m going to take the first bit of that, which is about Lonza, and then I’ll hand the second bit to Chris for the breakdown. And then what I’m going to ask you to do, Gena, once I get through those two, if you can actually repeat your last question, because I’m not sure we got it. But regarding the Lonza amendment, we are not providing manufacturing forecasts. Our plan has always been to scale up commensurate with demand and we initiated this process in Q1, and we’re pleased to have completed this agreement as we see encouraging demand for ZYNTEGLO. So, it’s really just part of our plan. And then, Chris, do you want to talk about the quarterly revenue?

Chris Krawtschuk: So, Gena, thanks for the question. And, look, while we’re not reporting infusion numbers, but you can see that patients are completing and moving through the process, which effectively then is translating to cash collections, reinforcing our balance sheet. And as a reminder, we have had 22 patient starts, which effectively represents approximately $63 million in gross revenue. So, you can see that it’s strong linear growth as we’ve described and that will continue. And then, can you do me a favor and repeat your question on the outcomes-based agreement? I’m not sure I understood it. I’m sorry.