Biogen at Leerink’s Global Healthcare Conference: Strategic Insights in Biopharma

On Monday, 10 March 2025, Biogen (NASDAQ: BIIB) presented at Leerink’s Global Healthcare Conference 2025, offering a comprehensive look at its strategic initiatives. The discussion, led by Alicia Alema, President of North America, and biopharma analyst Mark Goodman, highlighted both the promising developments and the challenges faced by Biogen in its key therapeutic areas, including rare diseases, Alzheimer’s, and lupus.

Key Takeaways

• Biogen is focused on overcoming patient identification challenges for its rare disease therapies.
• The company is planning a direct-to-consumer campaign for Lekembi to leverage high patient grant rates.
• SPINRAZA continues to grow, driven by switchbacks from other treatments and the potential of a new high-dose formulation.
• XERZUVE’s strategy is shifting towards targeting OB/GYN practices for postpartum depression treatment.
• Biogen is optimistic about its pipeline, particularly in lupus, due to high unmet needs.

Financial Results

• SkyClaris sales were about $73 million in Q1 ’24, with revenue fluctuations due to various factors, including Medicare Part D changes.
• Over 1,100 patients are on SkyClaris in the US, with 750 prescribers involved.
• SPINRAZA has penetrated over 70% of the SMA population, showing growth despite competition.

Operational Updates

• SkyClaris faces challenges in patient identification due to misdiagnoses and a lack of awareness, prompting Biogen to use AI-driven lead generation.
• Lekembi’s adoption is hindered by infrastructure issues and treatment duration confusion, although Biogen plans a broader DTC campaign.
• XERZUVE is targeting OB/GYN group practices to address the limited window for postpartum depression diagnosis and treatment.

Future Outlook

• Biogen remains committed to Alzheimer’s, optimistic about blood-based biomarkers and subcutaneous formulations.
• The company is excited about its lupus pipeline, viewing it as a significant opportunity due to high unmet needs.
• The potential approval of a high-dose SPINRAZA formulation in Q4 is anticipated to boost growth.

Q&A Highlights

• Alicia Alema emphasized the importance of clinical champions in driving drug adoption.
• The entry of a competitor, Lilly, into the Alzheimer’s market has created some confusion, which Biogen aims to address.
• Biogen is closely watching the impact of its expanded field force on XERZUVE prescriptions.

For more detailed insights, refer to the full transcript below.

Full transcript - Leerink’s Global Healthcare Conference 2025:

Mark Goodman, Biopharma Analyst: Let me just see. Are we ready to go? Great. Okay. Thank you very much for joining us for the next session at the Leerink Global Healthcare Conference.

I’m Mark Goodman, one of the biopharma analysts, and we’re lucky to have Biogen with us here. Alicia Alema, who is the President of North America, thank you very much for joining us.

Alicia Alema, President of North America, Biogen: Thank you, Mark.

Mark Goodman, Biopharma Analyst: So I think, we’ll go through the products and just kind of block them off. I think just and I thought we’d start with SkyClaris. So, let’s just kind of jump right into it. I mean, in The United States, back in the first quarter of ’twenty four, we learned there are about 1,100 patients on the drug, and you did about 73,000,000 of sales. And some of those patients were not paying patients.

And yet it seems like since then, it doesn’t feel like the revenue has changed much, 76, then it did an 82, you did a 71. It’s jumping all around. Help us with what’s going on behind the scenes because sometimes revenues don’t help everything, what’s going on. So maybe we can start with SkyClaris.

Alicia Alema, President of North America, Biogen: Well, thank you. And thank you for, having me here today, and thank you for everyone who decided to come to the room to watch this fireside chat. I really appreciate it. I think Skyclaris has been a very interesting journey to learn about. And you learn real quick that, you know, every rare disease is different from the other one.

And even though we have excellent rare disease capabilities, the Skyclaris or Friedreich’s ataxia patient population is quite different. So in the beginning, when we brought on Skyclaris, you know, a lot of those patients that you saw in the beginning, like the 1,100 you’re talking about, are all sitting at these centers of excellence around the country where these physicians know what Friedreich’s ataxia is. They know these patients have them, and they were waiting. And that’s also why when you saw our launch trajectory, we set the benchmark for rare disease launches. Even up till today, we still have the benchmark for best penetration of of a drug launch.

Well, once we got through the centers of excellence, we then have the rest of the patients, and the rest of the patients are now sitting in the community. And if I give you a little color around that, there are over 50 ataxias. So the patients we’re looking for right now do not know they have Friedrich’s ataxia.

Mark Goodman, Biopharma Analyst: Yeah.

Alicia Alema, President of North America, Biogen: They might know they have an ataxia. They also might think they have MS, which is one of the number one misdiagnoses, or ALS. So they’re not out there searching Friedreich’s ataxia information to go in and talk to their doctors, and their doctors might think that they have something else.

Mark Goodman, Biopharma Analyst: Yeah.

Alicia Alema, President of North America, Biogen: And so, like, you mentioned the 1,100 patients, well, we have over seven fifty prescribers. So that tells you how long this tail is of what we’re looking for to find a patient. So behind the scenes, what we have to do is, and I’ve mentioned before our AI model that we have, which is a very, sophisticated AI model. We get a hundred leads over a hundred leads a day. This model goes through claims records, EHR records.

I mean, you name it. They will then spit out leads, and I have over three field forces now that that work on this. I have a multilayer complex system of how we go out and find a lead. So we will have an inside team that will call these physician’s offices to say, is this have you heard of this patient? Have you heard of, you know, what they’re going through?

We see that there’s a claims record. If we think it’s a go, we then shoot a field force out to meet this physician. This physician then will not know what Friedreich’s ataxia is. They may know of who this patient is, but then they’ll say, I saw him five years ago. They probably sit with one of their other doctors.

Then I have another field force that will have to go to the cardiologist, the ENT, the physical therapist. And so when I tell you the mechanism now to find the one patient in the one doctor’s office, it’s the heavy lift of the education that is something that we underestimated because people do not know what Friedreich’s ataxia is. And so that is how we’re capturing patients now. And the numbers can be a little all over the place because, for example, a couple weeks ago, I had zero patients coming on board. Then just a week ago, I had 10.

And then sometimes we can find a family. And then sometimes, you know, it will be a misdiagnosis. And so we now also have, this is another interesting piece of information, I put my MS field force on it. So my MS team, which is doing phenomenally well this year, we noticed that, you know, they do have a great relationship with all of these neurologists across the country. And in order for a doctor to really go through the effort to think through a patient, which does, you know, they have to really clear out the cobwebs or ask someone to go through electronic health record, The MS patients have gone in.

I just executed them, a week ago. Within two days, I had a rep down in West Virginia find an FA patient in one of our MS neurology offices, and already a start form was submitted. So it just shows you, you have to go out and ask the right questions and find them. And so that’s why it’s a little lumpy. Also, you knew, that for the Part D, for IRA redesign, we also SkyClaris is about 30% of our hit, our net revenue loss, for that as well.

And so that’s what you’re kind of seeing happen right now.

Mark Goodman, Biopharma Analyst: Yeah. I mean, the the is it four thousand five hundred patients that we’ve identified kind of thing? Is that

Alicia Alema, President of North America, Biogen: Yeah. It’s like and we actually know a lot about some most of them, to be honest with you. And so we think that there’s five thousand five hundred of them are under the age 16, so they don’t qualify for SkyClaris. And then we believe there’s around 4,500.

Mark Goodman, Biopharma Analyst: Right. So we got 1,100 of them pretty quickly. And then Yes.

Alicia Alema, President of North America, Biogen: We’ve got we we penetrated, you know, and we have start forms in for for a good chunk of them as well. Now it’s working them through the system.

Mark Goodman, Biopharma Analyst: Right. Right. Right. So what’s the last number that you’ve given us? Just

Alicia Alema, President of North America, Biogen: I don’t know if we gave you a last number. It was probably probably around the 1,100 more, but we have more patience than that.

Mark Goodman, Biopharma Analyst: And we keep adding patients obviously given the numbers. Yeah. Yeah. Yeah.

Alicia Alema, President of North America, Biogen: And we keep adding patients. But the other thing, you have to keep in mind with SkyClaris. And another dynamic that is very hard for you to sort of plug into a model is that if they have a side effect, doctors, what will look like to you could be a taking three pills once a day, they may go down to one pill. And so you may not see the refills come through because they’ve had to taper down on the dose if they have a GI side effect, if something’s happening with their liver, or they’ll be pulled off the product. They’ll see if their liver enzymes stabilize and then they’ll be put on at a lower dose.

And so you’re seeing a lot of puts and takes that happen with refills, adherence, how they manage a side effect profile. And that and that’s what becomes also a little lumpy.

Mark Goodman, Biopharma Analyst: And there was also inventory that moved around. Explain that

Alicia Alema, President of North America, Biogen: what happened here. Inventory. So, you know, depending on when they order, depends on what week it falls in. So sometimes, you could have the start of the month on a Friday and inventory is built on Thursday. It goes into that last quarter, and there’s nothing we can do about that.

And so you do see and now because of where we are with our patient population, even inventory builds will become a little sensitive.

Mark Goodman, Biopharma Analyst: Yeah. Yeah. So I know that you don’t, you’re not responsible for outside of North America, but can you just give us a sense of where we are the drugs in, what key regions, what are some key regions it’s not in yet?

Alicia Alema, President of North America, Biogen: Yeah. So it’s in, I think about 15 markets about now, mostly in Europe. Europe’s actually doing a really great job with getting patients onto product. And you know that’s either through a commercial pay or through an early access program. Some are paid, some aren’t.

And so they’re actually growing at a nice clip right now, especially in patients, but you may not see it in revenue yet because depending on when we get reimbursement in that country. So we’re going country by country. The ones that I think, you know, that you’re seeing now, like Germany, Spain, Italy, France. And then the where we’re not is really in most of the regions outside of Europe and The US. However, we had an approval recently for Chile.

And if you look at we call it the intercontinental region. Brazil will actually hold half of the Friedreich’s ataxia patients out of all of those countries Interesting. Outside of US and Europe. And so we do expect Brazil later this year.

Mark Goodman, Biopharma Analyst: Later this year. Okay. So that’ll be the that’s probably the most consequential new region to come online this year. Yes. Yeah.

Got it.

Alicia Alema, President of North America, Biogen: And then also, I believe, Turkey also has quite a few patients. So they’re not really I think they’re on their EAP program, but you’re seeing quite a few patients go on product in Turkey.

Mark Goodman, Biopharma Analyst: Anything else before we move on from Skyclaris? What else? Anything that you want to kind of get across? I mean, pricing, Medicare Part D, we talked a little bit about that. I mean, these patients are thirty percent are Medicare.

Is that what it is? What percent do you think?

Alicia Alema, President of North America, Biogen: They’re about I think it depends. It also depends on our the thing that also moves around a lot is discounts and allowances for us depending on what happens in that quarter, but about 30%, I would say.

Mark Goodman, Biopharma Analyst: Right. Okay. Okay. Good. So, McKemby, I mean, look, you smile.

I mean, I lived through Aduhelm as well, so, you know, I can smile.

Alicia Alema, President of North America, Biogen: We were in that together. We were in that one together.

Mark Goodman, Biopharma Analyst: So maybe the first question is, you know, what have you learned over the past year, and what have you changed over the past year to help adoption better?

Alicia Alema, President of North America, Biogen: Okay. Well, there I

Mark Goodman, Biopharma Analyst: have loaded question.

Alicia Alema, President of North America, Biogen: Yeah. That’s a loaded question. There were many lessons learned, so far with Lekembe. I think we have said many times about infrastructure challenge. So I’m not going to go into that because that is a heavy lift for doctors.

Every doctor is going to have to do it, and they’re working through that. But the bigger lesson is if you can get the one doc, if you can get one clinical champion, they will push all of it through. And that is how you saw a lot of these IDNs start moving is that you needed that clinical champion. So I think that’s first and foremost. The second lesson learned, I would say, is really around, again, the education needed.

I mean, they didn’t really understand the clinical trials or how meaningful that would be for patients. And so the whole reason why a lot of offices haven’t moved yet is because they’re not yet that champion. But that champion can be moved if they are emotionally moved by either a peer or something that’s happening in the community or if a patient asks. So we have learned recently, we call it a grant rate. So if a patient comes in and asks for prescription, it’s called a grant rate.

Lekembe has one of the highest grant rates I’ve ever seen, and yet we don’t do a lot of patient to consumer education. So they’ve had to find out on their own, right? This has not been through a big broad campaign. And so because the grant rates are so high, what you’ll also see in our prescriber base is I have a lot of doctors who only have one or two patients on the product. And we’re going, why is that?

When you have we know you have many more, and they go, well, the patients asked for it. So they felt compelled enough to do it for the patients that asked, but yet for the rest of them, they’re waiting and seeing. So they’re gonna wait eight months. They’re gonna see what happens, and then they’ll think about it for the rest of their patients. And so with that at play, the things that we’ve done is one, I think, you know, we expanded the field force.

And what we did is we started putting two faces versus one face or two field forces versus one field force in a lot of these, doctors’ offices. And what I can tell you, the other lesson learned is relationships matter. So where we deployed Biogen representatives, as an overlay to the ACEI team, we see faster acceleration and more depth in prescribing than what you do in the rest of the nation. And these doctors were open, obviously, because it’s one of their reps that they’ve seen before. And secondly, there was a trust and already the relationship was there.

And so they were more apt to do the work than what they would prior. And so that has actually helped quite a bit. I know it’s early days, but that is something that is growing. And the second thing that you’re going to see happen, we also redid the detail aid, redid some of the key messaging now that we understand the landscape better. But more importantly, now that we know the grant rate is so high and we know that physicians are apt to say yes when they ask for it, you will be seeing us do a much broader DTC campaign this year.

Mark Goodman, Biopharma Analyst: Even on television?

Alicia Alema, President of North America, Biogen: Maybe even on television. Oh. Maybe even on television.

Mark Goodman, Biopharma Analyst: I mean, I it does make sense, especially if these people are coming in and asking for it.

Alicia Alema, President of North America, Biogen: They are. They are.

Mark Goodman, Biopharma Analyst: And so you think that some of these physicians who are, you know, writing for two patients who are asking for it, they’re waiting to what are they waiting on? Like, are they waiting for the drug to to see help? Are they waiting to make sure that it’s safe?

Alicia Alema, President of North America, Biogen: You know what? It’s it’s the it’s both, actually. It’s do they know how to manage if anything happens? Even though it’s only one or two patients, they’re very cautious because a lot of them have never dealt with

Mark Goodman, Biopharma Analyst: Yeah.

Alicia Alema, President of North America, Biogen: ARIA or even PML. Right? They’re not MS docs. Yeah. And then the second thing is, like, well, what’s the feedback?

You know, what do they say? Right. And so the stories that they give back are not the things that you see in a clinical trial. Like, you know, a physician told us the other day that a couple came in, and the husband had said it’s the first time she remembered my name in the morning. You know, it’s little things like that.

Or there was a a gentleman that came into the office where he’s an avid, like, he loves cooking, and he hadn’t cooked for over a year for his family. And he’d come in, and the family had told the doctor, well, he just opened up the most complicated cookbook and cooked us our first dinner. Right? So they’re wondering, what is the feedback that I get? What is it that I hear?

Like, do I know if the drug’s working?

Mark Goodman, Biopharma Analyst: Yeah. How many unique prescribers have we had so far? Have you given us that number? I don’t remember.

Alicia Alema, President of North America, Biogen: We have not given you the number, but I will tell you, it grows every quarter, but it’s still not nearly enough.

Mark Goodman, Biopharma Analyst: Yeah.

Alicia Alema, President of North America, Biogen: And so we still have a small percentage of the total universe that, we call on that have actually written the product.

Mark Goodman, Biopharma Analyst: Yeah. And what is going on with Lilly now that they’re in the market as well? How has that whole change the dynamic? And because I have always thought of big market, two players making noise, it doesn’t get any better than that. I don’t want three, but I love two.

Alicia Alema, President of North America, Biogen: Yes. I like two, too. I think two is a sweet spot. I feel the same way as you, and our hope is that the market will get bigger. I think it’s too soon to tell right now.

A lot of who we see that writes the competitor, the same doctors that obviously write our product. Because even if you go to a new office or a new physician, you face the same challenges that we’ve been facing for eighteen months. So that doesn’t change just because you’re a new product. Coming to a product decision, you still have to do all the workup. And so, so far, it’s everything that we sort of expected.

There hasn’t been anything unexpected to date. We haven’t necessarily seen, the market rapidly expand, as you know. I think if anything, there is some confusion that came out because of their recommendation of an eighteen month stopping rule, and doctors didn’t really

Mark Goodman, Biopharma Analyst: Well, I’m glad you brought that up because I has that created a lot of confusion?

Alicia Alema, President of North America, Biogen: It has because they’re like, are we supposed to stop? Are we not supposed to stop? And I think, you know, with Lekambi, we have an open label extension that shows you should not be stopping the product, that you still receive benefit even after plaque is removed, because your plaque can come back. And no matter how fast or slow the process is staying on product, you will perform better than not being on product.

Mark Goodman, Biopharma Analyst: I mean, from a patient’s perspective, you can understand this is a drug you know, to get rid of amyloid. Okay. Well, I just had a scan. I have no amyloid. Why am I on drug?

Alicia Alema, President of North America, Biogen: Correct.

Mark Goodman, Biopharma Analyst: I mean, you can understand why they would say that. Right? Yes. I mean, so Yeah.

Alicia Alema, President of North America, Biogen: Well, it’s the same reason why you don’t go off your antihypertensive or your cholesterol medication. Right? It’s a so they have to understand that it is a chronic disease with a chronic disease.

Mark Goodman, Biopharma Analyst: And it’s a little bit of a mixed message given that what Lilly is saying and what you’re saying right now, because that’s causing some confusion.

Alicia Alema, President of North America, Biogen: It’s confusion and, I think now with also the positive is with our IV maintenance also being at the eighteen month mark. I think physicians even like right here in the city, a physician came to present to our executive team, and it was the day we had the IV maintenance approval. And he said that he had called several of his patients, and they were very excited to go to the once a month dosing, but they did not want to stop product. So I also feel there’s a safetyfear that’s built into if you try and pull the product away.

Mark Goodman, Biopharma Analyst: Yeah. Yeah. How do you think about blood based biomarkers and sub q and just I mean, to to me, I think they’re just so I mean, isn’t there gonna be a massive change? I mean right?

Alicia Alema, President of North America, Biogen: Yeah. I mean, I feel like

Mark Goodman, Biopharma Analyst: How massive? Like, how do we quantify that?

Alicia Alema, President of North America, Biogen: Yeah. We were well, so I’d love to give you a number. But we were just talking about this with, Tim and the team is that everything is kind of coming together at the same time right now, really, for and I think for Alzheimer’s in general, it’s really great because there’s a lot of awareness now and much more awareness about Alzheimer’s disease than ever before and many things coming out for Alzheimer’s disease. It gives people a lot of hope and interest. And so when you think about the blood based biomarker, which I think will be so wonderful for the patient community and just so easy for them to confirm whether they have it or not, I think that that is going to be a game changer when it launches, when we get an FDA approved one.

Now if you looked or talked to a blood based biomarker company quarter over quarter, I mean, their numbers just keep increasing. So many more doctors are using the commercially available ones now, but they always followed up with a CSF test or a PET scan. They don’t trust it.

Mark Goodman, Biopharma Analyst: Every one of these Alzheimer’s meetings that we’re going to, CTAD or and it doesn’t matter. What we’re seeing is the correlation is just pretty high. I don’t know how much higher we can get. I mean, we’re practically at 90%, aren’t we?

Alicia Alema, President of North America, Biogen: Yeah. They want you at 90%. And so now it just needs to get FDA approved so you can start getting it reimbursed.

Mark Goodman, Biopharma Analyst: Yeah.

Alicia Alema, President of North America, Biogen: So and so the two big issues that we see in market research with blood based biomarkers today is one, they don’t they don’t have confidence in it.

Mark Goodman, Biopharma Analyst: Yeah.

Alicia Alema, President of North America, Biogen: And two, it doesn’t get reimbursed. And so with an FDA approved one, we think that it’s going to become much more easy.

Mark Goodman, Biopharma Analyst: Do you think that happens? Is it that a this year event? Is that a next year event?

Alicia Alema, President of North America, Biogen: We think it could be this year or early next year.

Mark Goodman, Biopharma Analyst: Right. So it’s later this year, early next year.

Alicia Alema, President of North America, Biogen: Yes. Now remember, blood based biomarkers, however, they’re not built like biopharma where you have reps that cover the entire Yeah. Country. And so getting them educated and entrenched will be the hard, you know, the difficult challenging part. And so we do need to figure out a way on, could we support, could we help in any way, because they’re not going to be able to have that widespread reach like we would.

Mark Goodman, Biopharma Analyst: I mean, the pushback on sub q versus every two weeks or four weeks, I mean, like, that’s also going to be a huge game changer, right? I mean

Alicia Alema, President of North America, Biogen: Well, it will definitely help with physicians not having to make sure IV infusion beds are open and, you know, getting their MRI scheduled the exact right time. So it will alleviate the work on the physician and the patient, for subcu. Now oddly enough, there are patients who do like coming to their IV maintenance appointments or IV appointments because for some of them, that’s their only community. Right. And so it will be interesting to see, I think sub Q maintenance will be a good option.

It’s a sub Q induction that will be the game changer. And to be able to offer them the different options, I think, is what also becomes really important for this patient population depending on what stage they’re in, how old they are, are they in a nursing home, are they at home alone, do they have caretakers, at least now they have options of

Mark Goodman, Biopharma Analyst: And the physician community knows this is coming, Right? Yes. I mean, you can’t really market it, obviously, not approved, but I’m just saying but they know it’s coming. The data’s there at the meetings. They they’re

Alicia Alema, President of North America, Biogen: They know it’s coming.

Mark Goodman, Biopharma Analyst: And so Biogen’s view is we’re committed here to this. We know this is coming. This is going to be a major change.

Alicia Alema, President of North America, Biogen: Yes. And, you know, and it comes subcu will come as well, induction next year along with blood based biomarkers. We just think it’s all happening at the right time.

Mark Goodman, Biopharma Analyst: Yeah. Yeah. I mean, it’s just I don’t know. This has been one of those markets where you kind of feel like there’s so many patients, but at the same time, there’s a lot of friction as we talked about, and you just think that there’d be some offsets and it will be ramping a little bit better. Outside of The United States, anything that’s happening different than in The U.

S? Like Japan We’re not in Europe yet, I know, but Japan and China, I suppose.

Alicia Alema, President of North America, Biogen: Japan and Japan had a really amazing launch. I mean, first, they had good pricing on the product, which was great. You know, their health system is a little bit different, so they had a couple centers of excellence that made it very easy for the patients to go through, and we think that that launch has been absolutely, excellent. But it just shows you that once you get your infrastructure set up, they also do DTC there, and they also use some of their primary care reps there. So they really, like, front loaded the launch and have done a tremendous job.

Mark Goodman, Biopharma Analyst: Right. Right. Right. Interesting. Anything else on Lekampi before we I want to talk about SPINRAZA a little bit.

Alicia Alema, President of North America, Biogen: No. I’m happy to talk about SPIN. Not many people ask about SPINRAZA.

Mark Goodman, Biopharma Analyst: I know. I know. But once I mean, first of all, I look at it as like first of all, it’s kind of unique that we have this small market. We have three drugs approved for. I think that’s

Alicia Alema, President of North America, Biogen: Shocking.

Mark Goodman, Biopharma Analyst: Shocking. For rare disease. Yeah. For rare disease.

Alicia Alema, President of North America, Biogen: Like how many people Yeah.

Mark Goodman, Biopharma Analyst: No. But After these But I kind of feel like like when you really look at the data, you guys have the best data. Yeah. And your high dose now is reason to get kind of rejuvenated even more. So I don’t know, give us a sense of what’s going on.

So let’s talk in The U. S. So what’s been happening in The U. S. Because no one talks about SPINRAZA?

Alicia Alema, President of North America, Biogen: Yes. Thank you for the question. I think first, you know, we’re talking about SkyClare, so I get that question about SkyClare. It’s like, oh, well, you know, how long are you going to grow for? I’m in year eight of SPINRAZA.

In the last three years, we’ve grown SPINRAZA, right? So it just tells you, and that was with two other competitors. If you wind back to, you know, basically ’9 ’20 ’19, ’20 ’20, that’s when the competitors started launching. And when the oral option launched, it was during COVID at, you know, stay at home orders where our patients for SPINRAZA couldn’t go in and get their intrathecal injection. Right?

And my field force was also on lockdown. So there was almost nothing. We did our best, but we lost a lot of patients during that time. Now everyone thought, oh, it’s just because it’s convenience. Actually, it was a perfect storm.

Fast forward to today, a lot of the patients that are coming on product are switchbacks. So what we’ve learned about the patient population is it’s not that they actually want the convenience. They are just searching constantly for more efficacy. And once they’ve switched off and they’ve seen a decline, they switch back on again. So a lot of this are the moving between products.

We also have a lot that have come from Zolgensma. Yeah. So we’ve had Zolgensma, they’ll see wearing off, and it’s like, I want to go on SPINRAZA. So then SPINRAZA HD. So high dose SPINRAZA really was born out of the fact that we were hearing from physicians’ offices many years ago, like we have this waning off effect, you know, we we we feel so great after we get that injection, and then right before the next dose, it wanes, like can I get the dose sooner?

So we said, well, what if we gave him a bigger dose? And so sure enough, we have higher dose. We’ll, we’re looking at getting an approval in fourth quarter this year. Patients are already asking about it.

Mark Goodman, Biopharma Analyst: Yeah.

Alicia Alema, President of North America, Biogen: But we believe it will provide another great option for them, especially if they’re looking for something that is perceived to be I think

Mark Goodman, Biopharma Analyst: it’s interesting you said that about the perfect storm of COVID because I would think in this market, it’s all about efficacy. When we talk to people they talk about efficacy. That’s all they want to really talk about. It’s not like the adverse events or anything to scare everybody away from using these products. So it’s interesting.

So your view is this is a growth product in The U. S?

Alicia Alema, President of North America, Biogen: Yeah. The US, I mean, the last three years, we’ve grown it. We have fierce competitors. We’re not going up against small little companies. I mean, they have a lot of money to spend, and they have good products.

Yep. But the team’s done really well. And and I think, you know, the switchbacks have been important, and we still get new patients every year as well on SPINRAZA.

Mark Goodman, Biopharma Analyst: Where are we on patients? I don’t even know when the last time you gave us a patient number.

Alicia Alema, President of North America, Biogen: We don’t do patient numbers anymore because at the end of the day, we’re all switching back and forth. We do believe over seventy percent percent of the population have been penetrated. And we do believe that where we’re going to get the rest of our business for new patients is really it’s the adult business that becomes important. We have a very large adult business and they do a lot more switching.

Mark Goodman, Biopharma Analyst: And on OUS, anything you can help us with there?

Alicia Alema, President of North America, Biogen: On Finrazza, they’re a little bit behind us in the sense of the competitors, right? We were U. S. Experienced the competition first and they’re now dealing with the competition. They’ve had a lot of lessons learned.

I think Europe is holding good ground. I think you see some weird things outside of U. S. And Europe when it comes to shipments or tenders, and things like that cause some lumpiness. But other than that, they’re doing well.

Mark Goodman, Biopharma Analyst: Yeah. So you feel this product is we’re we’re fully behind it. We’re supporting it. We think it’s a growth product. The high dose is gonna be a changer.

Alicia Alema, President of North America, Biogen: I think the high dose is is going to be very good for patients.

Mark Goodman, Biopharma Analyst: Yeah. So XERZUVE, we’re gonna hit them all.

Alicia Alema, President of North America, Biogen: I can’t believe, but I love

Mark Goodman, Biopharma Analyst: a good XERZUVAX question. So I guess the same question asked before, what have we learned? What have you changed since the launch?

Alicia Alema, President of North America, Biogen: So XERZUVAX, I’d say we’ve had the most learnings and probably where we’ve had the most change. XersaBay was a product, which if I can remind everyone, it was supposed to be for MDD and PPD. MDD obviously multi billion dollar opportunity, didn’t get approval and ended up launching PPD and launched PPD, but we prepared for MDD. So we went at this, we had very little investment. I think we told you we didn’t that we were very modest with our investment last year, had small field force footprint and thought through the data that you purchased prescription data that psychiatrists would be the ones that write majority of it because that’s what it showed in prescription data.

But we were wrong. There’s a lot of miscoding in this area. There’s a lot of things coded as PPD, but it was really MDD. And what we ended up learning is that OB GYNs were by far going to be the biggest champion for women and for PPD. And the OBGYNs, you also, we learned that you can’t just target one doctor because most OBGYNs sit in an actual, group practice now.

There’s aren’t a lot of individuals. Yep. Even though one physician will show as a high rider, they may just be putting the products under that one doctor. It doesn’t mean that that doctor is writing it. So we had to change our entire approach to one, targeting OB GYNs, two, going to group practices, not individual riders.

So now they have to do an entire group practice call because every single physician in there may be prescribing a product or seeing a patient with PPD. And then third, we learned that basically, you will be diagnosed and treated within the first ninety days postpartum. After that, the numbers dropped off dramatically. And within those first ninety days, there is only one appointment that a woman has for fifteen minutes, and in that fifteen minutes is the window where they have to get diagnosed and treated with XERZUVE. So it comes down to a split second to get a prescription for this product.

And for the for the physicians who understand PPD, they will make sure in that fifteen minutes it’s brought up. However, if you have a patient who knows what PPD is and they say, no, I know I have postpartum depression, the physician will also write even though they Yeah. Don’t know. Interesting. So we’ve had to change our entire model over over the year, and we think that this year

Mark Goodman, Biopharma Analyst: is gonna be a very big year. The focus, right, we changed the focus. You’ve had to change the messaging a little bit, right? Yeah. So how much advertising do we do?

Is this a DTC type of

Alicia Alema, President of North America, Biogen: So I believe yeah. I believe that this d this is the most perfect product ever for DTC.

Mark Goodman, Biopharma Analyst: I would think so too.

Alicia Alema, President of North America, Biogen: There are two fifty prescribers for PPD, in The United States, Two Hundred And Fifty Thousand Prescribers, which is which is large. And so we’re trying to go to a small slice in women’s health or in OBGYN in order to to cover, what we think is going to be the majority. But we also know that if you do DTC, that patients will then come in and ask for it for this one specifically. So we are looking into that. I saw some storyboards the other day.

I think we have some more work to do, but I’m not sure when we’re going to pull that trigger because we just put out also our expanded field force in this first quarter. And so I’m waiting and seeing how the expanded field force does, what it does with prescriptions. Is it really more depth or is it new writers? Right. Because at the end of the day, we need many more writers to come on Yeah.

Mark Goodman, Biopharma Analyst: So you’ve watched the pipeline evolve over the past few years. I’m just Eight years. Just curious, like, what your thoughts are about, you know, lupus or, you know, I I don’t know. Yeah. So I have drugs.

Yeah.

Alicia Alema, President of North America, Biogen: I have a lot of thoughts. I think, first of all, what I’ve loved about Chris coming on board is he’s put all the regional presidents at the table for for pipeline discussions and whether, we should move forward or not, which has been really great to be a part of. I think when you look back to when he started, he did a really large overhaul and reprioritization of our R and D. As you know, both groups, you’ve seen all the announcements through Fit for Growth and then also overhauling the pipeline. Where he has now doubled down and where we have made decisions is lupus, Alzheimer’s, and rare disease.

Mark Goodman, Biopharma Analyst: Yeah.

Alicia Alema, President of North America, Biogen: I was just asked in a meeting earlier this morning, you know, what are you most excited about? And, you know, I blurted very quickly lupus, because of the unmet need. I just happened to have met four patients not that long ago. And when you hear the unmet need and you hear how there is just really nothing out there for them, and it is this disease is devastating, for SLE or CLE, you can see that if these products, read out positively, it is a huge potential for the company. I also think in the pipeline, you’ve seen us do things like Hi Bio, which, I mean, Felsa is an amazing product.

And when you look at kidney and rare disease, I mean, if this works for AMR or PMN, I mean, we’ll have more competition for IgAN. Again, this will be very good growth for the company, especially before 02/1930. And then Stoke, you saw Stoke recently. And even though it’s ex U. S, I would have loved to have had that product in my portfolio.

Again, another perfect product for a high unmet disease. And even when you look at Europe and InterContinental region, even the growth that will happen just in those two regions will be great. And so I think that the pipeline is in really good shape right now. We have some really promising and we believe higher probability of success assets. And we’ve doubled down, as you know, in Alzheimer’s.

And so we’re kind of here to stay with Alzheimer’s

Mark Goodman, Biopharma Analyst: as well. Thank you. Thanks for joining us. Appreciate your time.

Alicia Alema, President of North America, Biogen: Appreciate it. Yes. It’s great.

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