Okay, thank you guys for joining us. Pleasure to have Biogen management. Really looking forward to this conversation. Alisha, thank you for making time. I'll let you kick things off.
Oh, thank you. I think you have a statement that you want to say before I kick off?
Yes. So we will be making forward-looking statements which are based upon our current expectations and beliefs, and these may differ from actual results. I encourage you to consult the risk factors discussed in our SEC filings for additional detail.
Thank you. First of all, thank you for inviting us, and having us here today. And thank you for all of you that joined in the room. I know you have other things you probably could be doing, so I appreciate that you came to the session today. I think, first of all, my name is Alisha Alaimo. I head up North America for Biogen. And I think before we start with maybe the questions, it's good to sort of give a little bit of a background of how, why Biogen is where it is today and what's happened over the last two years, which I think has been very different than the prior years.
That was with, first of all, the appointment of a new CEO, Chris Viehbacher, who's done really a tremendous job over the last two years with trying to think about how do we want to sort of evolve where Biogen was. I think when he was appointed, it was really a perfect time for this company to start making a shift from where we were. When you think about Biogen and all the products that we have, you know, everything is really for a very devastating disease. You know, whether it's for a couple thousand that's a rare disease or whether it's millions for Alzheimer's, they're really hard areas to sort of break into. So when he looked at the company and looked at where we wanted to move forward, he had five key priorities.
The first was, you know, how do we reduce our cost base? So you've probably heard over the last several quarters he's talked about Fit for Growth. Fit for Growth was an initiative where we ended up cutting out a lot of costs. We did a bottoms-up, build. Every org did. Each leader had to literally start from the bottom, go up, and start cutting where we think that we could so we could reinvest that money. That will, of course, by the end of 2025, be $1 billion in gross savings, $800 million in net.
Right.
The second thing was, reprioritizing the R&D pipeline. So you saw some of the, molecules we walked away from, and then you saw us heavy up. And, for example, recently you saw Dapi for SLE. We had a readout for that. We have Litifilimab, obviously BIIB080, another molecule that we call our crown jewel. And then also we have Felza. And then the third thing we did was how do we maximize our profitability? And so in the past, Biogen was known as the MS company, as everyone knows. And we really looked at that portfolio and said, "Where do we take some of that money?" We heavy up on the highest ROI initiative. So, for example, we still invest in Vumerity, which is our number one, it's number one branded oral. But how do we then put that into the fourth initiative, which is the product launches?
I can say even from sitting in my seat, it was literally my 100% of my savings went into 100% of my launches, which was for Leqembi, Skyclarys, which I know we'll talk about today, ALS, and then postpartum depression with Zurzuvae. And then last but not least, which we get a lot of questions on, and Chris has already done in the last two years, is BD. And we have a very big focus on BD, because we do know we will need to, you know, fit and feed our pipeline over the next couple years as well. We had the acquisition of Reata, which Skyclarys was really a beautiful fit into our portfolio. And then the second was HI-Bio, which was great for the pipeline with Felza. And we believe that both of those obviously will turn great value to patients and also the shareholders.
So that gives you sort of a really fast sort of view into what's happened over the last two years, which I think are critical as we now look at what's going to be next for Biogen.
Excellent. Excellent. Fantastic. Well, that's a great overview. Maybe I'd love to perhaps kick things off on the Leqembi side. And I think for a while, at least in my mind and for a lot of investors, it looks like Leqembi was just going absolutely nowhere. But it looks like sales numbers are now starting to look like we're putting up some numbers on the board. So, approaching, I think, almost $300 million run right now on a global basis. And there's a lot of layers to peel there. But maybe first, which is the part that's surprising me a little bit, is the Japan number coming in really strong. How do you? I mean, I realize that's not what you guys are commercializing, but I guess what feedback are you guys hearing on that dynamic and the momentum there?
Yeah. Thank you for the question. Well, first of all, Biogen does have a field force in Japan as well as in Japan.
Oh, you guys go marketing Leqembi there?
So we do have a field force there, yes.
Oh.
We did launch in Japan. And I think Japan is fascinating. First of all, it is an excellent launch. I think you saw the sales like double from quarter two to quarter three this year. And there's a couple reasons for that. First, it's a single payer system. So, you know, once it's approved, it is paid for. Very different than what you see in the United States, which I can give you, you know, all of the challenges that come with the multi-payer system here. And then secondly, they have these appropriate use guidelines. They have these guidelines that are very specific where they will lay out exactly what patients can get the product and how you have to diagnose and treat them.
Now, I think if you were to hear that first blush, you know, for example, if that happened in the U.S., you'd say, "Oh, that could be very restrictive to a launch." Well, actually, it's made it very clear. It's given them a blueprint, and it's moved patients very quickly through the diagnose and treat phase. And they've done very well. And so, you know, the Japan launch is off and running, and we think that it will still continue to be very successful.
Outstanding. I guess if there's one thing, Alisha, I want to clarify on the Japanese launch. Eisai showed some slides on the patient backlog that was ready to go in the U.S. and the patient backlog ready to go in Japan. And I think what they were implying was, there were 6,000 patients still waiting for treatment in the U.S. and 4,000 are on it. But on the Japanese side, it sounded like there was about 6,000 or so, of which only 500 are still on the wait list. And when I looked at that, I was like, does that mean Japanese, there was a big bolus effect? We're kind of benefiting from that, but the momentum will be a little more gradual from here? Or is that not consistent with your understanding of the market evolution?
So I think that they're still going to have good growth as they move through their launch. I think with a launch where you have a single payer system and you have centers of excellence, basically there's always going to be a bolus. You see it in rare disease. You see it anywhere where you have to go to the center. We saw it with Spinraza, you know. We saw it with Skyclarys. I think though now it will be about how do you get those community doctors to filter in those patients into those centers to get treated. So I do believe that they will still have good growth. And as far as the 6,000 in the U.S., you know, you have to look at where do those numbers come from. Those numbers are not exact.
You have to go to every single office to ask those questions of how many, you know, patients are waiting. I can tell you I was out in the field just two weeks ago visiting physicians actually in Florida. You know, the number of patients they say that they have waiting are massive numbers, right? So the waiting, the patients waiting, it changes literally by the minute and by the day. It depends on who's referring to which center and who's treating. So I would say, you know, when I take a step back and I look at launches, no matter what country they are in, the biggest thing you have to have is the awareness for the physician to drive that patient into the office.
If you sort of crack that, you're always going to have a line of patients waiting for the product.
Alisha, is there a scenario that in two to four quarters from now, Japan exceeds the U.S. in terms of size? Is that possible as you are modeling it all through?
So I'm not close to Japan, but I would say they better not because they have U.S. revenue and our patient numbers, so I think Japan will be very successful, but you know, from what I see in the U.S. and the numbers that you look at and all, even all the leading indicators, you know, I just saw the last two months of the blood-based biomarkers being used, the PET scans being used, everything keeps accelerating, and so the U.S. is just going to continue to grow and compound, and to be very explicit about it, you know, there aren't as many doctors as we still need prescribing the drug. The runway in the United States is huge when you look at the number of neurologists that can prescribe and the numbers that are prescribing today.
Even when you look at the depth, half of the doctors that are writing have still only started with one or two patients. They still have a long runway even in those offices. The runway in the U.S. is huge and the patient population is very large.
Got it. So, okay. So maybe just dialing down the U.S. side a little more. You said runway is huge. Docs are at one to two patients. Are you hearing that significant expansion's coming? They want to do more. It's just the bottlenecks in the system holding them back. Is that what you're hearing? Or is that an aspiration given that Alzheimer's is large, so it should go down that direction?
You know, this is a really, this market, you know, we've had to build this market. You know, it started back in the day with Aduhelm. We knew what we were getting into. And I think first and foremost, for those physicians that have really started from day one, I have to give them a lot of credit and I have to thank them because it is a lot of work. And I referred to the fact that I was in the field just two weeks ago, and I'm sitting across the desk from these physicians saying, you know, "Well, what is it? You know, what are you struggling with? Or why does it take so long?" And he looked at me and he said, "Do you understand how much work it takes to diagnose the patient? It's not about prescribing the drug.
It is how long it takes to make sure you're diagnosing them appropriately." And he said, "It takes a lot of time and effort." And he said, "And we just have to get through that for every single patient." And so in some of these large IDNs that have hundreds of patients now on product, they are well-oiled machines. So the bottleneck or the gating that people ask about will be different for every office. I will say the biggest part, and we call it infrastructure, but that infrastructure is different for each physician's office. And so when the doctor said, "It's a heavy lift," I said, "Well, what are you—what is so heavy for you?" And he said, "The biggest plan in my area says I have to do a CDR Sum of Boxes." He goes, "That's done in clinical trials, right?
That's one little thing, but it's the majority of his plans. And so he has to figure out what staff can do a CDR Sum of Boxes. How do you understand how to do it? His issue is not infusion. His issue is not PET. It's how do you get through sort of those first tests.
Got it.
In some areas, like you'll hear about a large IDN where they have hundreds of patients on, and they'll say, "Well, we're now running out of chairs, right, for infusion capacity." You can go to an outside AIC, except that IDN may not permit it because they want to keep those infusions within their network. And so then it becomes a negotiation on, do you open up more chairs into, you know, just an extra sort of room? You know, will they let you temporarily go to an AIC? Can you negotiate chairs with oncology? And so you see that every single one of them is just a little bit different. But what we also see in our market research is if a patient comes in and asks for it, the grant rate is very high.
I see.
A doctor will say, "You asked for it. I'm going to help you get on it," even if they think that it's a heavy lift. A lot of these doctors that are going through ones and twos, we have seen that a lot of times the patient really wants on the product, and so they do it. They start getting through it. Once they get to sort of five or 10, they start moving much more quickly.
Got it, so and I know subcutaneous may happen in due time as well, but let's hold that for a second. Based on the offering today and blood-based biomarkers, there's more adoption right now. I know you guys went from like about $30 million in the U.S. to about $40 million. Is that the cadence you expect? Is that the momentum, additional $10 million per quarter type of addition?
You know, I think that it will continue to be linear. We've seen some puts and takes. You know, like in the summertime, everyone asked, "Oh, is there, you know, a summer effect?" We won't know that until you get literally probably two years under your belt to see if there's sort of a, we call it the snowbird effect or, you know, a lot of patients flying back and forth trying to find their infusions. But then, like I look at October and November, and, you know, I'm seeing very good numbers, right? So it's a, I think it just depends on timing. It depends on when these sites come online. It depends on when some of the depth comes with the physicians.
So, you know, I would say to be safe, I would expect a linear trend, you know, at this point, until some things sort of change in the market.
Okay. Got it. And one dynamic, in the back of my mind, I'm a little nervous about is because it's not symptomatic benefit per se. It's a benefit that sort of cumulatively really starts to add up, but the patient doesn't know it immediately if something changed for them or not. Are you guys seeing any preliminary evidence on duration of therapy, where people say, "I've been on it for a year, now I'm going to fall"? Is there any dynamic like that at play yet? Because so far it's all about incident patients. I'm just curious about duration of therapy.
So, so no, we're not seeing that yet. I would say any discontinuations would be similar to, you know, what we saw in the trial, and, you know, you don't have a ton of patients hitting that year mark yet. What we are seeing, though, and it also now is showing up in our market research, and even when I was talking to some of the KMEs, the six-month mark seems to be an interesting mark for physicians because that is when patients tend to, and this is based off of qualitative, you know, speaking, they tend to come back and they start recognizing their differences, and every patient has a different thing that they will say that they have seen an improvement on, or something has changed. The caregiver will notice a change or a child will notice a change, and the parent.
And that is when the doctor goes, "It's working." And that's when we start seeing them accelerate more, more prescribing. So it's been interesting because as soon as they have the real-world experience, they get the feedback from the patient. You see them then diagnosing and treating more. You also see them talking to peers more. And what we've noticed with some of the physicians who've also accelerated is they're getting feedback from peers on the patient experience.
That's actually very interesting. I do remember the curves on this too. I guess what percentage of doctors have patients that are hitting that time point? Do we know? I realize it's very broad.
That's broad. I, you know.
Or what percentage of patients? What's the median duration right now across the patients in commercial therapy? Do we have a sense? Is it sub-six months?
It depends on when they've come on, but if you think about those IDNs, so just to put in perspective, from the first day they decide to prescribe, it took an IDN eight months to get first patient on board, so I'm going to have a lot that are coming into that six-month, a little bit over six-month time period at this point.
Between now and March.
Yeah.
Because we have a lot more of the six-month happening.
Yes.
Okay. Excellent. And then I guess that maybe takes me into the sub-Q dynamic. Is the chair issue in terms of infusion a huge deal as it relates to getting, like, are you hearing that patients are unable to get it because of that chair issue? Because I'm just trying to quantify, could sub-Q inflect, or are we still thinking this linear $10 million a quarter type of increase, or would sub-Q inflect that?
So to answer your first question, is a patient getting to a chair an issue? And I'd say my overarching answer would be no. I'm going to put a caveat on that, though. However, sometimes are drive times too far for them, or sometimes is that putting a burden on them? Yes. However, now in the Northeast and the Southeast and the Midwest, we've had very large AICs now put Leqembi on formulary, and we've now opened up many chairs across the country where, for example, we have a cohort of patients that were always going into New York City. They now can go to Brooklyn, Queens. You know, they have much more local options in Long Island than what they had before. Same in Florida. You know, they were going to these large centers. Now it's more closer to home. And so the chairs aren't necessarily the issue.
I think that where IV maintenance and sub-Q come into play, first of all, optionality for patient and physicians are always good because, like I said, no office is the same. Physicians do love seeing the patients, I think, upfront and in person for their IV, especially in those first six months and while they're monitoring for ARIA. But then if you are able to remove the plaque and go into an IV maintenance phase where it's only once a month, that again alleviates the burden on the patient. So I think that is a great option. If they can go to sub-Q and they don't have to travel, you know, which we don't know yet what that label's going to look like.
We don't know if, you know, they'll have an option of either doing it at home or going to the physician's office, but not traveling then becomes excellent for them. And then for induction subcutaneous, that is where it will be interesting to see how do physicians react because right now they're very used to doing the IV. So we'll see what happens once we get the label, but the subcutaneous induction becomes important because if a patient finds that to be much more convenient, they don't want to go in for an IV, they have that option. And so I think all of those things will become important to launch.
I guess, is your base case that you'll get a label where you don't have to, you can do it at home?
I mean.
That would be your objective.
You're close to it, but that's.
That would be the aim.
That would be the aim.
And we hear back, I think 1Q , is that right?
1Q for maintenance subcutaneous, correct?
What does the subcutaneous induction timeline look like right now?
So on that one, generating data to support a lower dose, which we've said we think there's a potential to utilize a lower dose based upon the overexposure that we saw in the initial data presented at CTAD, in 2023. So we're looking at that lower dose, generating the data. We haven't guided towards the timing of a filing, but Eisai, as a regulatory lead, has guided towards a potential regulatory decision, by the end of their fiscal year 2025, which is ultimately the end of March 2026.
Okay. Got it. So maintenance sub-Q, we found out in 1Q 2025, induction sub-Q 1Q 2026.
Sorry. So for maintenance, maintenance IV is January 2025. The filing for subcutaneous maintenance, so again, after an individual has gone through a certain period of IV and removed the plaques, that rolling submission was completed at the end of October. The FDA would have up to 60 days to decide to review the filing and decide whether to accept it. Once accepted, we would expect to get the review type, whether it be standard or priority. So somewhere, depending upon that review type, would put a regulatory decision around mid-year, give or take.
Oh, mid-year. Okay. Got it. So there's a mid-year date for the subcutaneous maintenance. IV maintenance is January 2025, and subcutaneous induction could be Q1 2026.
Correct.
Okay. Excellent. Mike, anything else you want to touch on subcutaneous?
Yeah. Before we depart from this, just want to kind of go back to what.
The timelines on this, I have to admit, have dragged materially long. I remember talking to Priya about this here last year, and we were still sort of talking about how induction might involve a slightly different strategy than maintenance, but it's taken a little longer. But conversely, it looks like the market development was sort of taking its own time anyways.
It is.
Part of that was the fact that the original data presented for subcutaneous was at 720 mg weekly dose, and that was in treatment naive individuals. As I said earlier, we saw an overexposure, so actually additional plaque removal as compared to the 10 mg/ kg biweekly. For treatment initiation, we wanted to utilize a lower dose for maintenance after the amyloid had been cleared. There we needed to ultimately go ahead and generate three months of immunogenicity data in order to support the filing. That is more of a kind of check-the-box exercise for the commercially proposed dose. We needed some time even for the maintenance to go ahead and generate that data to support and complete the filing.
Got it.
Right. I was going to say just to harken back to Eisai guidance. Eisai has a nice slide that says performance of America's pharmaceutical business. And for their fiscal year 2024, they're guiding to JPY 26.5 billion, which kind of implies like a 65% growth in the second half compared to the first half. So in the first half, they did JPY 10.5 billion. To get to JPY 26.5 billion, they need to do JPY 16.5 billion in our fourth quarter, in our next year's first quarter. And I'm thinking what you said about how a lot of these patients will kind of hit their six-month mark pretty soon. Is that what will get them there to that extra JPY 16.5 billion to hit their guidance?
I think that, you know, the acceleration, which you'll see obviously going into Q1 of next year is going to be many things coming into play. I think one was getting a lot of these AICs on board, right? We opened up a lot of infusion capacity through getting Leqembi on the formulary. I think secondarily, one KPI that I look at quite a bit is how many new writers come on board. And that becomes really important for Leqembi because number one, again, there's a long runway. And if you look at Q2 to Q3, we had a 40% increase in number of new writers. But remember, when they come on, they only do one or two patients for like six months, right? And so what you will start seeing then is do they start getting depth?
So if you already have them writing and setting up infrastructure, getting that depth becomes a lot easier. And so that will also become an accelerating factor.
Alisha, is it your expectation that the current linear trend of $10 million in sales per quarter could be $15 million-$20 million at some point next year?
I mean, we would hope so.
Yeah. Wouldn't guide at this point.
We're not going to guide, but, you know.
Right. Okay. But aspirationally.
Aspiration, you know, my aspirations are larger than the numbers we probably guide to, right? You know, and as a commercial leader, they kind of need to be to push the teams, but you know, at some point, these systems need to come on board and move, and it is going to take some time, and I think with a competitor out there, it will help as well, by the way. However, you know, at some point, these patients need to move through.
Got it. Part D, would you be able to get Part D reimbursement on subcutaneous?
So, you know.
If it's at home, if that's the label that comes through.
Part D, right now with Part B, I think everyone knows it's actually, you know, pretty good across the board. We have very good coverage across the board for Part B. Part D is a different beast as we know. And so there you become, you need to go and negotiate all of your individual contracts. We, of course, believe at this point we will get Part D coverage. But, you know, now with a new administration, with the IRA, we're also looking at what things are changing. I think what works for us right now under the current IRA is that the patient out-of-pocket costs are going to be much less, right? Part D becomes a very attractive option for patients. But remember, you know, as with Medicare, Medicare is overnight, you get reimbursement and it's done.
Part D, you do need to negotiate through every single plan.
And everything right.
Yeah. So we would have to start that at least fairly early with the planning board. It's not an immediate inflection because you do need to get access through those plans.
Got it. Okay. Got it. Excellent. Mike, anything else on the Leqembi side just before we move on? Because I know there's other topics.
That was it.
Okay. Excellent. So maybe let's transition quickly now to some of the other programs. Skyclarys, I think right around $300 million sales run rate. And it looks like I think going from Q1 to Q2 to Q3, there's been some, like, there's a lot of growth from Q4 to Q1. And I think since then there's an expectation that the launch has tempered a little bit. Could you just walk us through the dynamics there? And are we still on path towards perhaps a $1 billion product, or is it something a little more lower than that?
So, you know, Skyclarys, rare disease, Friedreich's ataxia. We've learned a lot since we obviously acquired Reata and working in this space. I think what you saw in the beginning in the launch dynamics is you have a cohort of patients who were diagnosed, knew they had it, ready to go, sitting at centers of excellence. That was a large bolus. It took a lot to work through the long line of patients. You have some super users out there in the country who just knew, like they. We have one doctor who claims he has 250, you know, patients, right? So they really just moved through these patients. Now that we got through the majority of the bolus, I can say I still have a cohort that we're working through now.
The majority of my new patients that are coming onto product is one doctor, one patient, and they don't know they have Friedreich's ataxia. In fact, when my team goes in to talk to them, they'll say, "We believe you have a Friedreich's ataxia patient," and they say, "What is Friedreich's ataxia?" So that is where we're at now, and so what we have built, I have three teams that one hunts down leads, a second goes down and chases them out in the field, and a third works in my, my COEs. That, those teams are fed by an AI engine where we're able to take all of the electronic health records over the past several years. We know which doctors these patients, it's obviously de-identified where the patients go to, and then we have phone calls.
I mean, they're making, you know, 60 phone calls in a day, a team of them to physicians just to try and find where these patients are sitting. And then we send in the field. And so now they're also slower progressors. So even when the physician calls the patient, the patient will say, "Well, I'm kind of doing okay. I'm over the age of 50, you know, I'm kind of okay." And the doctor will say, "You should come in, see if you have Friedreich's ataxia. There's now a product for you, and it could slow your progression." And so that obviously takes time. You know, these people are working, you know, they're with their families, and they've got to take time to come in, get diagnosed, and decide if they want on the treatment.
That is why it shows that we have sort of slowed. It's the finding and the pulling the patients in. However, on the flip side, again, we still have good runway. So we still have ambition of making this a billion-dollar product. It just takes a little time to get there. But we have, we add patients every week. We add patients every month. We add patients every quarter. And you'll see puts and takes in some of the numbers. You know, we've been asked a lot about discons, right? Like, are you seeing a lot of patients disconning? And it's no different than the MOXIe trial. But what you don't see is some of these patients stop because they may have an elevated liver enzyme, but they eventually come back. They may come back at a lower dose, but they do come back, right?
So it's not a true discontinuation in that sense.
Got it. What's the target population again?
In terms of prevalence pool in the U.S.?
Oh, 4,500 is the epi number. And, you know, 5,000 was, you know, the total epi, 500 of those are under the age of 16. And so the other thing that will give us a good boost is once we complete the trial for pediatrics.
Got it. I remember last time you guys disclosed patients on therapy. I think you guys had a thousand patients that was Q4 last year. Sales are up 50% since. Is it reasonable to assume we're kind of like in the 1,500 patient range right now?
I think it's reasonable to assume that we've had great market penetration. You know, we still have the best market penetration out of any rare disease drug. The problem with guiding to patients is what I had just said to you, where some will stop and they come back. So we have a lot of puts and takes in this patient number, which makes it a little inconsistent.
So, Alisha, is there a world in which where we could say 2,000 may have started, 1,500 are on it? So you've kind of hit a close to 50% penetration already at some level. Because when I hear 50%, I'm thinking you're starting to get to an upper limit of what the realistic, penetration could look like.
Yes, except for our penetration is basically the patients that we know have had a start form and are still on drugs. So, it's about how we've maintained them.
Okay.
Yeah.
Got it. Is it realistic to assume 75% peak penetration type of thing, and then we obviously have to adjust for how many are realistically on the drug?
You know, I typically don't guide to that. I think though, if you look at benchmarks and you look at what happens, 70% is usually around the benchmark that you see for penetration. You know, look at Spinraza. It's been on the market for eight years, two other competitors, and we're still getting new patients. We're still finding new patients that we didn't know were out there. So it will move. And I think we're going to see that as with most rare disease launches, those numbers, the epi numbers do change eventually because more patients discover that they have.
Yeah. In fact, Alisha, you kind of preempted my question. I was going to ask you, to what extent could Spinraza be used as a, as a revenue comp as we could try to model this launch? Rare disease kind of, you, you found out more that there were more patients than initially anticipated with Spinraza. Could this be kind of a reasonable comp to, say, Skyclarys or, or no?
It is only in the fact that we look at the market penetration. But for example, as if I compare launch to launch, we're beating the Spinraza market penetration. And Skyclarys will not have really a true competitor the way in which Spinraza did, and so that also helped that two competitors came in and took over the market, but they also took some of the patients, right? So that was part of the problem.
Got it. I should know this. This is just U.S. sales, right? $300 million that we're discussing right now, the run rate?
Global.
Yeah, it's global.
This is global sales. I see. I see. I see.
We're now in over 15 markets outside of the U.S.
How much is U.S. of the 300 million?
We will be 50/50 eventually, you know, eventually right now where the majority of it because Europe is getting online, but Europe is growing actually quite quickly.
Okay. Excellent. Maybe transitioning very quickly also to Zurzuvae. Am I saying that right?
You are.
Okay. Excellent. Next phase of growth, I think you talked about it. Could you just remind us what that is?
Zurzuvae has been, I think, for a lot of people, a pleasant surprise. You know, we had really planned on launching an MDD. We really built an amazing, very well thought out plan on, on that launch and then ended up with the PPD label, which I think people in the beginning were, were disappointed by. But it's the first ever, you know, indicated product for, for PPD and for as a 14-day treatment. It's very appealing, especially to mothers who don't want to be on a drug long term. And so what we've seen is this drug has actually taken off quite well with very little resourcing. We were very mindful that we didn't plan for PPD. And so we put not, not a lot of resourcing behind it. We went out very thoughtfully with Sage. And in fact, we got a couple of things wrong.
You know, we thought that the psychiatrists would be our big writers. In fact, if you look at prescription data, it will show that, and it will show that they write a lot for PPD. In reality, they actually don't. The OB-GYNs now have taken over as really our major prescribers. And we now, you know, fast forward to today, we thought OB-GYNs may write one prescription, you know, every now and then. But now like two-thirds of them are doing over two prescriptions since they've written. And so we're seeing that they're actually getting a good depth. We also see that in these large practices, it is much easier to grow this product than when you go to the single doctor, single practice like you did with some of the psychiatrists.
That is because you never know in the OB-GYN practice who is actually seeing the PPD patient. It might just land under a prescription under a certain doctor, but all of these docs are seeing it. So you've seen an acceleration in our launch now the last two quarters. And that's been a lot because of these OB-GYNs have had depth in their office practices. We've now decided to expand. We will be expanding the field force. We have posted the roles. We now have a little bit of a tweak to our go-to-market model. And so now us along with Sage will be expanding by January 1st. Sage actually did their expansion as of October 1st. We're now coming online January 1st. And you will now see us increase our reach and frequency, especially with the OB-GYNs and the writers.
We now know much more for next year.
Got it. Excellent. Maybe just continuing down, some of the additional topics I wanted to make sure we touched up on. Vumerity, my understanding is, 2033 is where you guys have the rights until on the IP side. Is that right? Or is there any generic settlement or anything that we should be aware of prior to that?
Currently, we have three Orange Book patents, each expiring in 2033. There is Zydus', so ultimately Biogen last year filed a complaint against Zydus on the basis of copyright infringement. That trial is currently set for July of 2025. The final regulatory approval of Zydus' generic product is stayed until we have the outcome of that trial. But that's probably all I can comment in terms of ongoing litigation. Alisha, I don't know if you want to say anything about Vumerity more broadly.
Yeah, Vumerity is one of those products that we decided to put more money behind. In fact, this year it's performed, you know, very well. We saw good growth in Vumerity so far. It's the number one branded oral. Doctors really like it. And, you know, also keep in mind there's a lot of generics out there, especially for Tecfidera. But doctors and patients also love the patient services that come along with prescribing some of these products. And so Vumerity's actually turned out to be a very good product for us, and so we have put more money behind it.
What's the main patient service that stands out on this?
Oh, I mean, we do kind of everything in patient services from, you know, getting the start forms put through, benefits investigation. They call and ask questions about, you know, the product. It's they end up having sort of their own case manager in a sense that they have a relationship with that they can kind of troubleshoot, and the case manager can troubleshoot through the offices for them.
I see. Okay. Got it. Ocrevus, what's the expectation on biosimilar entry for you guys?
I would say it's hard to speculate on the exact timing of biosimilar entry. I mean, with that being said, we do expect that Genentech would be entitled to the 12 years of regulatory data exclusivity per FDA regulations. With an approval of biosimilar, our royalty, our tiered royalty structure would be cut by 50%.
Right.
However, I think the important thing to note here as well is that, you know, Genentech is moving forward with different lifecycle management initiatives. They got approval for sub-Q Ocrevus. They also have a high dose formulation they're evaluating. So ultimately, you know, we do believe that those can help protect and extend the franchise versus biosimilar competition. But in terms of kind of specific entry, timing of entry of biosimilars and sales guidance, Genentech is solely responsible for development.
But would you agree consensus mismodels Ocrevus in the sense that consensus has like a biosimilar erosion being modeled, whereas from a royalty perspective, there's a 50% cut, regardless of all those initiatives the day the first biosimilar enters?
Per the contract, there would be a 50% cut to the tiered royalty structure upon the approval of the biosimilar.
That should equate to 50% sales cut to Biogen, correct?
If sales remain the same, depending upon the specific tiers, it could.
Got it. And then also just to clarify, if the trial for Gazyva and lupus nephritis hits, you guys got a royalty on all of that, right? Because you own the molecule.
We do so across indications, we would, our royalty would remain intact and profit share.
Okay. Which actually brings me to sort of like a bigger picture question then. It looks like Biogen's making a pretty significant investment on the lupus side. It's a question I brought up on the earnings call as well. But if I just go in a silo and ask myself, where are we seeing the most compelling lupus data and development? It looks like the B-cell depletion approaches, at least on early data, show very remarkable remission in lupus. And that happens to be the pocket where Biogen's sort of not investing a lot of time. So I'm just curious, how are you guys thinking about that? Or are you limited in going there because of some of the Roche collaboration on CD20?
I haven't called out any limitations. I would say, you know, with the B-cell depleters, obviously we've seen some encouraging data, you know, small patient numbers. With that being said, I think there are some questions around in terms of long-term durability of a response, what that looks like. And that's something that obviously the data will suss out over time. Really specifically for us, I think we're encouraged by Dapi for a few different reasons. So our CD40 ligand. I mean, we saw what we viewed to be a competitive response on BICLA, which is obviously a registrational endpoint. But then beyond that, kind of understanding the treatment objectives that physicians have in the real world, trying to prevent that breakthrough disease activity in terms of flares, and be able to reduce the high dose of corticosteroids.
You know, these are, these are endpoints that we've constructed to be able to understand the clinical profile of Dapi, and we're seeing consistency across that, which gives us, which encourages us to believe that if approved, this can be an important product for patients. The other thing I would point out in terms of CAR-T is that it's not easy to do from an operating room.
No, CAR-T, sure.
So in that sense, obviously, you know, we'll see if that might be reserved for a subset of patients, those that can, that are refractory, for instance. And then should there be a more bispecific, for instance, in terms of B-cell depletion? I mean, there, I think we're even earlier in terms of data. So we'll have to see what that shows us as well. But we feel good about the clinical profile we've seen with Dapi so far.
If Roche hits the Gazyva trial in lupus next year, I guess how does that change the dynamic versus your Dapi launch? And how do you guys balance the two?
Yeah. So we would have to see ultimately. I know they've gotten good results in lupus nephritis. With that being said, you know, lupus nephritis is a more specific indication. So we'll have to see how the B-cell approach plays out in kind of a more broad SLE where you may have involvement of different and multiple organ systems. But again, we'll have to wait to see how that data plays out.
Okay. Got it. And this is a, I think you may have heard me bring this up as well. Is there any chance under the new RFK and the Trump regime that somehow your first phase III forms the basis of a very early approval in lupus? And Alisha has even more work to do.
It's a good question. I mean, we've been saying for some time now that, you know, our expectation, our current expectation is that we're going to have to run the second trial. You know, we're planning to do that this year.
Are you guys attempting any conversations in D.C. towards this?
You know, engagement with the FDA will be ongoing. We do that for any phase III program that we can do. But I guess to underscore right now, our current expectation is we'll run the second trial, the supportive filing.
Okay. Mike, anything else on lupus just before we transition on? We have one minute and 40 seconds.
No. No.
Okay. Perfect answer. All right. Felzartamab, I want to touch up on this program a little bit. So, in terms of the duration of response, I noticed the three relapses after stopping therapy at six months. How should we think about those? And in general, how should we think about other CD38 programs replicating this type of data set?
Yeah. So I think, you know, the one important thing I'd point about the kind of remission, the loss of remission, that's specifically in antibody-mediated rejection. So that's in a situation, indication where you're receiving a non-self organ. That is, across the three indications where we currently have proof of concept, that's the one where we're seeing kind of a rebound of the response. So if you look at IgAN, for instance, if you look at primary membranous nephropathy, you know, there you're having, from that, you know, six-month, nine-dose treatment regimen, you're getting a prolonged response out to two years. So in AMR, the one you're citing, we did see kind of features of rejection begin to return at the one-year mark that we didn't see at the six-month mark.
And there you know this is something where we believe additional doses may be necessary in that specific AMR indication. And right now we're designing a phase III that can accommodate some of that retreatment paradigm. So we'll look at that there. And in terms of you know other anti-CD38s you know right now we believe we're leading with the anti-CD38s and the autoimmune indications. You know felzartamab specifically has a specific epitope that epitope that allows for the specific depletion of those plasma cells and plasmablasts when it's generating those autoantibodies. So with that being said you know the mechanism by which we're doing that is not dependent upon complement-dependent cytotoxicity right? So that gives us some potential to see a reduced infusion-related reaction benefit versus the approved therapies as well as shorter infusion times.
But on top of that, obviously, we'll look to see what the phase III data shows us as well.
Got it. And then finally also, ITP, is that an indication you guys would consider? I know there's some interest in that space in general.
Yeah. So we have characterized felzartamab as a potential pipeline-in-a -product type approach. So in indications where we believe that an anti-CD38 approach makes sense, it's something we could certainly explore. In ITP, we have seen some very early data with an anti-CD38 approach showing some encouraging results. So it's something that we're thinking about. But, you know, the felzartamab team right now is looking at, you know, different lifecycle initiatives, including other indications where we might make sense.
Excellent. Listen, thank you guys so much for making time. It's great having you.
Thank you.
Thank you guys.