Biogen Inc. (NASDAQ:BIIB) Q1 2023 Earnings Call Transcript

Operator: We will now take a question from Michael Yee of Jefferies. Please go ahead.

Michael Yee: Hi. Thank you. Good morning. We had a question around your expectations post reimbursement around the LEQEMBI launch. Appreciating you can’t give too many specifics, but how should we think about that in the context of consensus modeling $40 million to $45 million, $400 million for next year? Maybe you could help right-size how things start off, whether there’s a bolus or a number of patients already in the queue and in the context of how we should be modeling the next four to six quarters? Thank you.

Christopher Viehbacher: Yes, I wish I could give you some more guidance on that. As I’d like to say, I’m pretty confident in the three to five year outlook. The next 18 months are a little more difficult to model even for us. There is an awful lot of interest. There probably will be some queuing. There is going to be a question around the — how quickly can the system flex. The way I would think about it is and the way I look at Biogen is I think Zuranolone actually is a product that can actually contribute faster to our sales growth in 2024. And I do think that one, yes, it’s a paradigm shift, but there’s a clear patient benefit and we don’t have all of the infrastructure challenges to overcome. So to me, I look to more to the impact of Zuranolone next year. And the — we’ll be able to give a lot better idea by the end of this year once we see what’s the initial take-off in the first six months once CMS issues its reimbursement.

Operator: Our next question comes from Robyn Karnauskas of Truist Securities.

Robyn Karnauskas: Hi. Thanks for taking my question and all the colors has been very helpful. So just on if there is a registry, can you just talk to if you would foresee a registry being how much of a bottleneck it might create? How might it be paid for? And so help us, when we see that decision, understand what the challenges would be or it may not be as cumbersome as some might think? Thanks.

Christopher Viehbacher: Well, there are certainly versions of a registry that are not particularly cumbersome and the devil is going to be in the detail. That’s why, again, we would hope that actually CMS reimburses this product just like any other product. When you think that diverse and underserved patients in the health care system suffer disproportionately more in Alzheimer’s, it would seem that increasing the barriers for those patients by the need for navigating a registry would be highly unfair to those patients. But we’ll wait and see. Our belief is that the data from CLARITY are extremely clear. The benefits are by no means limited to what you see in the CDR Sum of Boxes. As Priya said, when you look at those activities of daily life, which are evaluated by people who are with these patients every single day and you have half a dozen measures and each one of them individually is statistically significant that says to me that — and versus placebo, this says to me that the people who see these patients every day understand the benefit of this new medicine and treatment.

And so I think the data are compelling and we would hope that there isn’t a registry. And if there is a registry that it is minimally cumbersome for patients to act and their caregivers to navigate.

Operator: We will now take a question from Marc Goodman of SVB Securities.

Marc Goodman: Good morning. Priya, maybe you could just help us with what’s similar about these programs that were stopped? I mean, obviously, there’s a few in stroke and a few others. But what is similar there? And it was interesting, strokes in Phase III, so does that mean that we could see some other late-stage assets that get cold from the pipeline? Just philosophically, just big picture, how you’ve thought about these decisions? Thanks.

Priya Singhal: Sure. So the way we’ve thought about these decisions is really we’re looking at every program in great depth and several times over and thinking about what are the options, what are the operational and strategic and regulatory challenges, but also opportunities. And so really, it’s an integrated view of where we believe that our resources would be better applied to other programs in our portfolio currently. That is, I would say, the common denominator across all the divisions that you’re hearing from us today. We believe that we should be spending time elsewhere. Now having said that, you said the BIIB093 is in Phase III. I can’t really comment on what might be the outcome. But for now, we are really discontinuing development.

Operator: We will now take a question from Terence Flynn of Morgan Stanley.

Terence Flynn: Great. Thanks so much for taking the question. Maybe a follow-up for Chris on Zuranolone. I think during your prepared remarks, you noted that this asset is underestimated. And based on your answer to the prior question, it sounds like potentially you think there could be some upside to numbers. So should we read that as — is that the takeaway, that you think there’s upside out of your consensus estimates here for that asset? And then just any update on the commercial footprint in terms of the build and what that might ultimately look like over time? Thank you.

Christopher Viehbacher: Yes. Thanks, Marc. It is interesting, and I look at it, and I take what analysts and investors say very seriously. And — but I definitely see that, as a company, we see a much higher potential for Zuranolone than what the street has. And I’m trying to figure out why there is that gap, I haven’t really come up with a good answer other than I think the investment community has been so focused on things like rare diseases and oncology where you’ve got some very clear biomarkers, you’ve got some very precise medicine. Precision medicine is a big thing in both of those fields. And we’re back into primary care. We’re back into a disease state that is — has a lot more challenge in actually diagnosing, even as you look at different indications.

For instance, we take something like bipolar depression and major depressive disorder and general anxiety disorder and these things are often seen in the same patient. And indeed when you actually talk to psychiatrists, they’ll tell you that this is a — this is truly personalized medicine. Psychiatrist tends to be less swayed by guidelines, by what KOLs say and more about understanding the individual patient needs. So this is not what people have been used to looking at. It’s all clinical data and everything else. And so I think from a commercial model point of view, the market is having a little bit more difficulty understanding how does the physician make a decision about their patient. I can tell you is that we’ve talked to a lot of patients.

We’ve had patients into our global executive committee. We had physicians talk to our global executive committee. It is a much different approach than certainly what our company has been used to in terms of dealing with neurologists. But what is also really clear is that there is a significant unmet need. Patients cycle through therapy. They’re not adequately satisfied by those therapies. There’s an awful lot of stigma here and staying on medicine only reinforces that stigma. I’ve talked to physicians who say, we have people coming into the emergency room and we can’t help them. There are no beds. We give them an SSRI or something like that and hope that someone is going to watch them for six weeks. So the fact that you can have a medicine that responds quickly.

If you’re in a depressed phase, this is a very dark part of people’s lives. And when you hear the patient stories about how suddenly their life has changed. We had a patient who’ve been suffering on and off for almost 20 years, a mother of three children, grandmother of five children. And within days, she felt better. She’s gotten her qualification as a fitness instructor. She’s going now for a pilot license. I mean this is really transformational for so many patients. And that’s what I really go by in. Another way I look at it, Marc, is I look at when you’re recruiting salespeople. We have 27 roles. The first line manager roles in our field force that we’re looking at. We had over 4,000 applications for those roles. And these are people who are working for great companies and supporting great products.

And I remember when we were launching Aubagio and there weren’t high expectations of Aubagio. But when we built that field force, we were able to recruit a great team. And salespeople do their own diligence. They tend to want to be a part of medicines that they see as important. And I see a lot of signs where I think this is going to resonate with the patient. It is certainly resonating with the sales folks that we are recruiting. And I certainly hear it from a lot of key opinion leaders. So it’s hard to — the only thing that I see where there’s a note of caution is that it is clearly a paradigm shift and I’d like to say it’s easier to change your spouse of 20 years than it is sometimes a physician’s prescribing habits, but because physicians do rely on their experience.

But I do think there is a major unmet need here and I actually think there’s an awful lot of potential. I’m very excited about this product. I think if I just listen to patients, I always like to say if there is an unmet need and I can see a differentiation versus existing therapy, the drug will be a success.

Operator: Our next question comes from Jay Olson of Oppenheimer.

Jay Olson: Thank you for the update and congrats on all the progress. Could you talk about the ideal capital structure for Biogen? And how much incremental debt could you take on for the purpose of business development? Thanks for taking the question.

Christopher Viehbacher: Mike, do you want to take that one?