Biogen Q2 2023 Earnings Call Transcript

Quartr
Provided by Quartr
July 25, 2023

There are 16 speakers on the call.

Operator

Good morning. My name is Ruth, and I will be your conference operator today. At this time, I would like to welcome everyone to the Biogen Second Quarter 2023 Earnings Call and Business Update. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session.

Operator

To allow other participants time for questions. Today's conference is being recorded. At this time, I would now like to turn the conference over to Mr. Chuck Traiano, Head of Investor Relations. Mr.

Operator

Traiano, you may begin your conference.

Speaker 1

Thank you, operator. Good morning, and welcome to Biogen's Q2 2023 earnings call. Before we begin, I encourage everyone to go to the Investors section of biogen.com to find the earnings release and related financial tables, including our GAAP financial measures and a reconciliation of the GAAP to non GAAP financial measures that we will business. Our GAAP financials are provided in Tables 12 and Table 4 includes a reconciliation of our GAAP business. We believe non GAAP financial results better represent the ongoing economics of our business and reflect how we manage the business internally.

Speaker 1

We have also posted slides on our website that will follow the discussion related to this call. I would like to point out that we will be making forward looking statements, which are based on our expectations. These statements are subject to certain risks and uncertainties and our actual results may differ materially. I encourage you to consult the risk factors discussed in our SEC filings for additional detail. Business.

Speaker 1

On today's call, I'm joined by our President and Chief Executive Officer, Chris Bebacher Doctor. Priya Senghal, Head of Development and our CFO, Mike McDonnell. Chris, Priya and Mike will each make some opening comments and then we'll move to the Q and A session. Business. To allow us to get through as many questions as possible, we kindly ask that you limit yourself to one question.

Speaker 1

I will now turn the call over to Chris.

Speaker 2

Business. Thank you, Chuck. Good morning, everybody. I'd like to start off with Lechem B. And I think before we really get into all the business.

Speaker 2

Interesting details of commercialization and competitiveness. I'd just like to pause for a moment. This is an historic moment in healthcare history. Business. We're talking about the very first disease modifying treatment that's been approved full has received full approval from the FDA and reimbursement from CMS.

Speaker 2

And there have been literally dozens business. And that's important for a couple of reasons. The first is that There's an awful lot we still don't know. We are really at the beginning of a journey to really understand Alzheimer's disease and how we can affect this disease. But business.

Speaker 2

But it's also going to have a big impact on the practice of medicine. Physicians haven't been able to really help patients very much beyond perhaps prescribing to nepezil or products like business. And the treatment that we are proposing here really is going to change an awful lot of how physicians practice and treat these patients. Business. So as we start thinking about intent to prescribe and how physicians are looking at things, business.

Speaker 2

We're actually not going to know that until we actually get out there on the marketplace and see how patients respond. Aduhelm did get approved, but as you all know, it never really got out of the and business. And never really got launched. So this is really a first and whenever you're first, We're going to be discovering an awful lot and a lot of this is just not that predictable. I would again just call out business.

Speaker 2

Kudos to our colleagues at Eisai. Within a very short period of time, they were able to get regulatory filings in the business. So this is going to be truly a global launch. Business. Now we just had the AAIC last week and Priya will cover off a little bit more about that.

Speaker 2

But one of the things that has become obvious business. When we start looking at daneumab and lekanumab, these are 2 very different products. And business. And I don't think most people have actually really looked at that. Most people are looking at, okay, we've got an A beta antibody and we're moving plaques.

Speaker 2

But there's a whole lot business. And this is going to evolve over the next months years. This is a these are different products. Business. They have different mechanisms because they have different binding.

Speaker 2

They've been studied in different populations. And of course, they have a very different safety profile. And all of these differences are going to play out in the marketplace over the coming months years. Business. And it'll be interesting how that is, but I would just caution everybody as we get into this and you see all of the data, business.

Speaker 2

There's an awful lot of subtlety to this, and it's going to be quite interesting from a commercial point of view. The launch is underway in the U. S. Business. We did get full approval earlier this month and CMS approval.

Speaker 2

That has significance also for others. This is going to encourage a lot of other companies to be investing in research and blood diagnostics. It's also, as you know, going to be an unusual business. There's an awful lot that has to be done. We're going to have patient navigators to help navigate the process to understand how business.

Speaker 2

Treatment will occur, getting reimbursement. We will be working with physician offices, an awful lot of change that will have to occur in the practice business. No practices on a day to day basis. There's an awful lot of education around safety, making sure that the right patients are in place. Business.

Speaker 2

We have reached out to about 700 centers to date. We're also getting reimbursement beyond CMS. Business. We have Medicaid, for example, in 48 out of the 50 states so far. And we have had very good business.

Speaker 2

So I think the launch of BEKEMBI is off to a very good start and we'll of course keep you up to date as we get further information. I'll move on to another slide here. One of the things that we've been doing an awful lot in the business. The past month is really making sure that we are well positioned for growth. And as we looked at the company, there's where we were.

Speaker 2

Business. As you know, today, we have a relatively mature product profile. Generally, when you have a mature product profile. You'd expect the level of investment to go down. We have actually relatively high operating expenses when we benchmark versus other companies.

Speaker 2

Part of that is an overinvestment in legacy products, but we also have an extremely centralized governance. We've got many organizational levels. We have a low standard control. On average, we have a standard control of 3. And then as we looked at the R and D pipeline, we've had 5 different heads of R and D in 10 years.

Speaker 2

And that's not good for an R and D organization. And as a result, we ended up with some products that I think were relatively high risk and high cost and not of the highest value. And so we've been through an extensive project to really review those R and D programs. And as we looked at, well, where do we want to be? Well, we want to be making more value based decisions for existing products.

Speaker 2

We don't want to just remove the promotional effort timely. Biogen is still 25% market share in multiple sclerosis. We have the highest market share by considerable margin. And so there is there are an awful lot of patients who depend on Biogen products, but I think we can do that smarter. Business.

Speaker 2

There is a need obviously to have strong investment in our new product launches. It's important clearly to manage cost, but shareholder value business. We need to get decision making closer to customers. We want greater agility in the organization and we want to focus on high value projects in R and D. External growth will really give us the opportunity to diversify away from business.

Speaker 2

Diversify into rare diseases, immunology and psychiatry. So business. We did this redesign effort. What we did was a bottom up exercise to look at where do we need to be as a company to business. What kind of internal governance mechanisms do we want?

Speaker 2

What kind of metrics do we want? What kind of accountability? And so there's been, I'd say, a complete redesign of Biogen and that will lead redesign of Biogen and that will lead some cost savings. There are gross cost savings, which will be about $1,000,000,000 in annualized savings per year. Of that, we expect to invest at least $300,000,000 in growth opportunities going forward.

Speaker 2

Business. So this is an opportunity really to make sure in this year before we get into the product launches that we were truly fit for growth. And with that, I'll turn it over to Priya.

Speaker 3

Thank you, Chris. We believe that the traditional approval of lekembi is a significant milestone for the Alzheimer's field. We also recognize business. The pursuit of effective therapies for Alzheimer's is far from over. Biogen and Eisai are continuing to generate data on lekembi business.

Speaker 3

Amyloid pathology can begin years before the onset of symptoms. Business. There is the potential to maximize therapeutic effect of lekembi by treating earlier to delay or even prevent business. Tisai and Biogen initiated the AHEAD-three forty five trial in 2020 business. This consists of 2 sister trials in cognitively unimpaired individuals business.

Speaker 3

Aged 55 to 80 with intermediate or elevated levels of amyloid on PET screening and they will be evaluated over 48 months. With the approval of LAKEmbi in the U. S, we also modified our business. We are now ready

Operator

to introduce our next question.

Speaker 3

I will now turn the call over to the business while being enrolled in the trial. We believe the clinical profile of lekembi is uniquely suited for the early intervention approach. Business. With robust plaque clearance, low incidence of ARIA and optionality of longer duration treatment to potentially maximize clinical benefit. We are working to improve and simplify business.

Speaker 3

We have two areas of focus: a subcutaneous formulation, business where the auto injector to potentially enable at home administration is underway. Keysight recently presented modeling data at AAIC suggesting that subcutaneous lekanamab provides similar exposure and amyloid plaque reduction and biweekly IV formulation, discuss the results of the company. Regulatory filing is expected by the end of Q1 2024. Business. 2nd is maintenance dosing, evaluating less frequent maintenance dosing in the Phase 2 open label extension.

Speaker 3

Business. Regulatory filing also expected by the end of Q1 2024. We are also continuing to analyze the CLARITY-eighty data where we have observed consistent reductions in both amyloid and tau PET and improved clinical outcomes business as we aim to better inform treatment decisions for patients. CLARITY AD study business. We did not use baseline tau PET as an exclusion criteria and enrolled a broad population of early AD patients business with varying degrees of tau pathology at baseline.

Speaker 3

This important aspect of the CLARITY-eighty study business allowed the generation of data on individuals with low tau burden that has not been collected in other Phase 3 programs. Business. At AAIC, Eisai presented baseline characteristics and a new analysis containing the initial results business from the TAU PET sub study of CLARITY AD. In this analysis, individuals enrolled in the TAU PET sub study were categorized into high, medium and low groups based upon tau burden measured at baseline. Business.

Speaker 3

Lecanumab administration showed a clinical effect in the overall population of the Taupek sub study business. Notably, a large effect size was also observed in the low tau population defined in this analysis, business, which does represent the early phase of AD. We believe this data further supports business. The clinical benefit observed with lekembi in the broad early AD population and again emphasizes the importance business. Biogen plans to build upon our industry leading position in therapeutics for abeta business.

Speaker 3

And our Northtown by advancing a multi target, multi modality portfolio, business, inclusive of also other emerging targets in the Alzheimer's disease pathway. This is inclusive of programs targeting tau. Business. Turning to SMA, the interim results from the RESPONSE study We presented at the Cure SMA Conference recently and highlight that most participants business. Investigator and caregiver reported suboptimal clinical status across multiple domains at baseline business following Solgesma treatment.

Speaker 3

This included motor function, swallowing of feeding ability and respiratory function. Business. Potentially, we believe this is due to likely incomplete transduction of motor neurons following gene therapy administration. Business. The interim results at 6 months show improvements in motor function in most participants business as measured by the increased total HINE2 score from baseline with no new emerging safety concerns identified.

Speaker 3

Business. Overall, we believe these results suggest that there may be potential for additional benefit with SPINRAZA treatment business following Solgen Smakrit's administration. The R and D organization, as Chris mentioned, has spent significant time and energy over the last several months in conducting a comprehensive review of Biogen's R and D programs business as we aim to improve the risk profile and productivity of the pipeline. We made a number of significant decisions and identified the programs we want to prioritize and others where we assess the challenges resulted in a low probability adjusted return business. We believe that this has resulted in a leaner pipeline business with an overall greater probability of success and a sharper focus on key programs.

Speaker 3

Business. The examples shown here all have data readouts expected over the next few years. VIBAT, business. A Phase 2 tau targeting ASO, which has Phase 1b data showing a time and dose dependent reduction business. In CSF total tau and phospho tau as well as tau tangles visualized by a tau PET.

Speaker 3

Business. Litifilumab, a subcutaneous anti BDC8-two antibody currently being evaluated in 2 Phase 3 studies this is a very strong start to the Phase twothree study in cutaneous lupus erythematosus. Business. BIIB105 and ATAX2 ASO being evaluated in a Phase III study in broad sporadic ALS, business. We expect a readout mid year 2024.

Speaker 3

BIIB122, a LARP II ASO being developed in partnership business. With the business. We are also aiming to increase the expression of paternal UB3A in Angelman syndrome and we expect the Phase 1 to read out mid year 2024. In summary, business. This past quarter, we continued to make significant advancements across our pipeline, most notably with the traditional approval of lekembi business.

Speaker 3

While our initial substantial review of the pipeline is complete, we will continue to evaluate both current and potential new R and D programs using a data driven approach with a keen eye towards risk balance and value creation. I will now pass the call over to Mike.

Speaker 4

Thank you, Priya, and good morning, everyone. I'll provide some highlights and color regarding our financial business performance for the Q2 and all of the financial comparisons that you will hear are versus the Q2 of 2022. Business. Total revenue for the Q2 was $2,500,000,000 That's a decrease of 5% at actual currency and 3% at constant currency. Business.

Speaker 4

Non GAAP diluted earnings per share in the 2nd quarter was $4.02 business. Total MS Products revenue was $1,200,000,000 that's a decrease of 15% at actual currency and 14% business at constant currency. So a few recent updates to the MS business this quarter. First, the decline in MS business. The Q2 was attributable to generic entrants for TECFIDERA and broad competition in the MS market.

Speaker 4

We did not see much in the way of channel dynamics during the Q2. 2nd, as we did announce previously, Tecfidera's regulatory market protection in have not yet fully exited some of the EU markets and some generic products remain in the channel. The pace of generic withdrawal has been slower than we business. Regarding Tysabri, we have previously said that there may be a Tysabri biosimilar launch in the U. S.

Speaker 4

And EU sometime later in 2023. And while we have not seen any biosimilar launches so far, we could see an approval and launch in the coming months. Business. Moving on now to SMA. Global SPINRAZA revenue of $437,000,000 increased business.

Speaker 4

1% at actual currency and 5% at constant currency. SPINRAZA growth in the U. S. Was 12% and that was driven by patient growth. Business.

Speaker 4

We were encouraged by the performance this past quarter and believe we are making good progress against our goal of returning SPINRAZA to consistent growth. Also as Priya mentioned, we are continuing to generate data to support the efficacy profile of SPINRAZA, and we believe that this along with the expected overall market expansion should help enable continued improved performance for SPINRAZA. Business. Biosimilars revenue of $195,000,000 was flat at actual currency and increased business. We are continuing to manage supply constraints for IMRALDI and BENEPALI and are monitoring this situation very closely.

Speaker 4

Business. We've referenced previously that we are evaluating whether this business could create more value outside of Biogen, and we are engaged with multiple interested parties and will provide further updates on that process as appropriate. Alzheimer's disease revenue, which includes revenue from Aduhelm and the lekembi collaboration equated to a headwind of $20,000,000 to revenue during the Q2. As a reminder, Lechembe revenue represents our 50% of in market revenue less 50% of commercialization expenses. We expect this line to continue to be negative in 2023 as the ramping business.

Speaker 4

Revenue of $433,000,000 was down 1% and included a $12,000,000 operating loss related to Lonsumio. Business. As a reminder, starting this quarter, our pretax profit share on Rituxan, Gazyva and Linsumio decreased business. From 37.5 percent to 35%, and that's due to the achievement of certain sales targets for GAZYVA as part of our contractual agreement with Genentech. Contract Manufacturing, royalty and other revenue of $198,000,000 was notably higher year over year and that was driven mainly by the timing of batches.

Speaker 4

A couple of details regarding Q2 expenses. For the Q2, non GAAP cost of sales was 24% of total revenue and that includes $34,000,000 of idle capacity charges. Business. We continue to see higher cost of sales as a percentage of revenue as a result of product mix and idle capacity charges and in particular, business. The increases that we are seeing in contract manufacturing revenue increases our overall cost of sales as a percentage of revenue.

Speaker 4

So in terms of modeling for the remainder of 2023, I'd offer that we believe contract manufacturing revenue will remain strong and will contribute to a higher cost of sales as a percentage of revenue for the remainder of this year as compared to the 24.1% that we saw discussion in the Q2. 2nd quarter non GAAP R and D expense includes roughly $13,000,000 in estimated study closeout costs this related to BID 93. As Priya mentioned, we're now substantially complete with our R and D prioritization. We estimate that this will result in gross savings of approximately $250,000,000 next year, business. So this will be partially offset by natural increases in R and D due to portfolio progression.

Speaker 4

The decrease in 2nd quarter SG and A expense was attributed to roughly $70,000,000 of savings initiatives and that was partially offset by approximately $35,000,000 of reinvestments, business mostly related to launch costs. We continue to expect our operating expenses to be lower in the second half of the year business segment in the first half as we complete the run rate savings from our previously announced cost initiatives as well as a modest impact from our new Fit for Growth business. So now I'd like to take a minute to provide a little bit of additional detail on our new Fit for Growth program. Business. This program will include changes to our operating model with a significant reduction of certain centralized functions.

Speaker 4

Business. A substantial portion of the $700,000,000 of net annual OpEx savings are expected to come from a net headcount reduction of approximately 1,000, which we expect to right size the company with our business plan and enable us to return to sustainable growth. I would reiterate that the OpEx savings shown here are on an annualized basis. Business. We believe that this is an efficient program with 70% of our expected gross OpEx savings to be realized as net savings.

Speaker 4

All in, we expect a very modest impact on 2023 expenses and believe the net OpEx savings will be split business. Roughly equally between 2024 2025 and all of these savings are incremental to any previously announced cost reduction program. A few quick comments on our balance sheet, including the approximately $813,000,000 that we business. During the quarter related to the sale of our equity stake in Samsung BioEpos, we ended the quarter with $7,300,000,000 in cash and marketable securities. Business.

Speaker 4

On June 30, we had $6,300,000,000 in debt and that puts us in a net cash position of roughly $1,000,000,000 We continue to generate steady positive cash flow from operations with free cash flow of $416,000,000 business during the Q2. And finally, now let me turn to our financial guidance for full year 2023. Business. The business remains on track with our forecast for the full year. And today, we are reaffirming our full year guidance of a Full year 2023 revenue declined in the mid single digit percentage range as compared to 2022 reported results and full year 2023 non GAAP diluted earnings per share of between $15 $16 and you can refer to our press release for other important guidance assumptions.

Speaker 4

So now I'll turn it back over to Chris for a few closing comments.

Speaker 2

Thank you, Mike. In addition to reengineering our cost base, we're actually also reengineering the business. We've already had 2 approvals this year, the Celcidie and Kembi in the United States. Business. As we look forward for the rest of the year and into early next year, we have a number of other important milestones for our portfolio.

Speaker 2

Business. We are expecting a decision by the PMDA in Japan in Q3, by the EMA in Europe business. In the Q1 of next year and in the Q1 of next year also in China, we also are expecting a decision by the on zuranolone, actually next week potentially. And then We also are continuing to evolve the lekembi. As Priya said, we are expecting to be able to submit business.

Speaker 2

The regulatory dossiers for Lechemvi subcu in Q1 of next year and also a regulatory filing for maintenance dosing next year. Business. So in addition to that, with the new product approvals that are expected, We're going to continue obviously to look through our external growth opportunities. As I have said before, this is an opportunity to expand the portfolio more into rare diseases into immunology and neuropsychiatry. So with that, Chuck, we'll turn it back and invite questions.

Speaker 1

Thanks, Chris. Operator, can we please poll for questions?

Operator

Yes. Thank you. Your first question comes from the line of Brian Abrahams with RBC Capital Markets.

Speaker 5

Hey, good morning guys. Thanks so much for taking my question and congrats on all the developments. So we recently saw some competitor data at a medical conference. And I guess I'm curious as you've seen things evolve here, what are the most important learnings that you've been taking away on the overall business. And can you maybe expand a little bit more on your latest views on how you expect the competitive dynamics to play out in the space and the impact to your overall launch strategy.

Speaker 5

Thanks.

Speaker 2

Thanks for the question, Brian. This is going to be super interesting business. From a commercial point of view. Because there are an awful lot of different factors at play here. Business.

Speaker 2

I think as I said, the markets are sort of thinking there's 2 A beta antibodies here and they remove plaque and That's it. And the story is actually a whole lot more complex. First, I would say, these are 2 products with business. I really go after the problem in a different way. And I think one of the most interesting things that's going to come out of this are the soluble protofibrils.

Speaker 2

These are the most neurotoxic forms of abeta. And lecanumab goes after those whereas denanumab doesn't. And business. And these are the soluble forms. And I think that will actually play a factor in our view, which is that this is going to be more of business.

Speaker 2

Chronic disease that you can remove the plaque, but these soluble forms, and this is judged by what we're seeing in some of the biomarkers, could actually still continue to play a role, which is why our belief is that we will need maintenance therapy over time. But there's also a difference in how business. These patients were studied, 1st, much different patient populations. Lekanumab was study is actually in an earlier patient population, roughly 2 thirds were in MCI and 1 third in mild and then denanumab was the reverse. And this is important because there's different rates of progression amongst these patients.

Speaker 2

Business. And so actually and when Priya talked about these low tau, which have no overlap with the low business. Tau, low to medium tau that denanumab study. These are patients that would really progress quite slowly. So they actually see an effect like that, business.

Speaker 2

I think really speaks to the efficacy of this product. Then there's also all the different endpoints. Business. Lilly measured their primary endpoint on a Lilly designed endpoint. Lequanimab views the gold standard, which is the CDR business.

Speaker 2

But when you start looking at activities of daily life, you start to see differences and there are some other markers where we think business. We can demonstrate where efficacy is going to be. And then of course, safety will be a big issue. Remember most neurologists, If they've seen ARIA before, it's been pretty rare. I mean, we do know that ARIA can occur even in the placebo group, but it's not something they'll have seen very often.

Speaker 2

And so this is going to be a different thing for them first to think about monitoring for safety with the MRIs. But It's one thing to be at a conference and look at safety from a data point of view. It's another thing I think to actually be looking at MRIs and seeing ARIA. And I think the safety benefit of the canumab will be quite important to physicians as we go forward. So there are a number of dimensions here that I think will be developed over time.

Speaker 2

There's going to be business. All the different blood diagnostics that come along. Personally, my belief is that we're going to be seeing treatment progressively over the years business. And earlier patients before too much neuronal death has occurred. And of course, that's where Lekimbi's benefit will business.

Speaker 2

We'll arise where they have already studied much more of these patients. Generally, I would say Lilly has been focused on looking at subpopulations business. And trying to say, okay, in this subpopulation, we've got this result and that subpopulation. But when physicians are dealing with patients in their practice. They don't want to deal with these subpopulations.

Speaker 2

They want to have a medicine that actually has broad coverage. And I think that's where lekembi will also business. Demonstrate its benefit. So it's going to be quite interesting. There's lots of data here to pour over that's come out The AIC and a lot of that will just become much more tangible over the coming months years.

Speaker 2

Business.

Speaker 1

Thanks, Chris. Can we poll for our next question, please?

Operator

Yes. Our next question comes from the line of Mark Goodman with Leerink Partners.

Speaker 6

Yes, good morning. Mike, just to make sure we're all aligned here with the numbers and the cost savings. So OpEx $4,500,000,000 for 2023. So we should be thinking $3,800,000,000 in 2025. And then business.

Speaker 6

How do we get there with respect to SG and A and R and D? Is this are they about even? To help us think about how the P and L is going to look. Thanks.

Speaker 4

Business. Yes. Mark, thanks for the question. So, your math is correct. Our goal would be to achieve a full run rate of the 700,000,000 business.

Speaker 4

Savings in 2025, so on an OpEx base of 4.5 that would take it to the neighborhood of about 3,800,000,000 business. The savings will be both in SG and A and R and D. We've already done quite a bit in R and D as we talked about that will yield a lot savings with our prioritization program, but we'll also be looking at ways of conducting our clinical trials, our existing trials more efficiently. Business. So the overall savings will be a mix.

Speaker 4

We're not providing full granularity on whether R and D will be plus or minus business. The $2,000,000,000 number that you threw out, but I would estimate that the savings from here would be probably a little more weighted business. To the SG and A line and a little less to R and D, but ultimately the savings will come from both sides. Business. The gross margin, that's a trend that we expect will continue at least for the near term.

Speaker 4

And when you look at the product mix, we obviously have business. The continuing declines in the some of the MS products, which are on the higher margin side and then you have business. Contract manufacturing that's really growing quite a bit year on year. So we do expect to see our cost of sales as a percentage of revenue, at least for the near term this is to be a bit lower than what we've or I should say the cost of sales percentage would be higher, the the gross margin would be lower than what we've seen in the past. And then over time, as lekambi becomes profitable and ramps up, business.

Speaker 4

We should hopefully see some recovery up on the gross margin line.

Speaker 1

Thanks, Mike. Can we go to our next question, please?

Operator

Business. Yes, our next question comes from the line of Robyn Karnauskas with Truist.

Speaker 7

Hi. Thanks for taking my question. I guess I would just be curious initially as you're talking to doctors about if there's a difference between the academic community and the community setting and interest in using drug and coordinating that, Can you give us more details as to how laborious and how easy the CMS registry now that it's up and running is and what questions they're asking? Thanks.

Speaker 2

Business. I think first on the registry, all the feedback is this is Manageable, I think everybody would prefer not to have a registry, but personally been on it. There's drop down menus. Most of the data are available from the record. So we think that that part should be okay.

Speaker 2

There's some bumpiness around the pet scan reimbursement that should be clarified in the next 90 days. But I think where we are now, the one pet Scan that is included should not be a barrier. I think there's just the mechanics actually of seeing patients that will change. Business. There's going to be a need to do more of the cognitive testing, getting the PET scan or the lumbar puncture, business.

Speaker 2

Figuring out where to go with the MRI infusion centers and then getting the MRIs. Business. There will be a routine that will develop in offices, but to start with nobody's doing that right now really. Business. I mean, we obviously have some centers that have been able to start infusing the chendy during the period before business.

Speaker 2

Full traditional approval. But if we look at the masses, everybody's having to gear up for this. Business. I think one of the other things that I would say is, there's been so much disappointment in this field over the years, a lot of hope, but a lot of these medicines business. And so I think there's been an awful lot of wait and see amongst the some of the medical community.

Speaker 2

Are we really going to get business. Are we really going to get CMS approval? So I think now that that is in place, which is, as I said before, I think is a really seminal moment in business. We'll see the practicalities of this. And we've always said that this is going to be business.

Speaker 2

A relatively measured uptake on revenue. I will say that the whole field organization is geared up for this. This is a this much more complex field organization than what you would have with a typical launch with the care navigators, with MSLs, business. With field reps, with regional thought leader professionals. So there are going to be a lot of people Actually holding hands with patients with physician practices trying to help make sure that this is as seamless as possible.

Speaker 2

And business. But it is not clearly as simple as just prescribing the pill and

Speaker 1

going down to your local pharmacy. Business. Thanks, Chris. Next question please, operator.

Operator

Your next question comes from the line of Mohit Bansal with Wells

Speaker 8

Fargo. Great. Thank you very much for taking my question. And maybe a question for Priya. So when you think about subcutaneous lekambi and you'll see the data later this year, But how do you think about positioning it?

Speaker 8

Is it do you think it is more of a maintenance treatment after the IV The cabi versus an induction kind of treatment and how important is Cmax to get and

Speaker 3

session. I think maybe before I answer that, I'll just say that Biogen and Eisai are really looking to simplify and improve the patient journey. And this is a multi pronged effort. 1 is subcutaneous formulation, which can address the infusion capacity and other issues potential for an auto injector and self administration at all. And then the second is really thinking about how lekembi can be positioned to really address the long term duration question that is still out there.

Speaker 3

The good news here is that Lecambi does have the opportunity to be treated to be used with a long duration and the question is what is the right this maintenance duration for this therapy. And with regards to subcutaneous, the data that we just presented at AAIC business. We're modeling data to show that really the subcutaneous formulation would be about 7 20 milligrams administered business. Now, the important thing here to understand is that really it is business. The hope and the data kind of point to the fact that safety could actually be better with the subcutaneous formulation.

Speaker 3

So we might have lower rates of ARIA and the filing is expected to be complete by Q1 2024. I also expect that more data Isai has communicated this business will be released at CTAD this year. So I think let's wait for more of that data, which is I think forthcoming and we look forward to the hopefully simplifying the patient journey.

Speaker 1

Thanks, Priya. Next question please.

Speaker 3

Business. We'll

Operator

go next to Umer Raffat with Evercore.

Speaker 9

Hi, guys. Thanks for taking my question. I feel like there's an elephant in the room and I do think we should speak to it. And Chris, this one is for you specifically. And the question really is investors are very curious business.

Speaker 9

What was your thought process on 2 specific occasions in the last few weeks? First, when you were first told about the proposed changes to the Board, business. And second, what was your thought process in deciding whether or not you needed to put out any disclosures?

Speaker 2

Business. I think more fundamentally, there's been a significant change business with our Board. And anybody who knows anything about Boards, you only make significant change to the Board through a consensus of the Board. Business. The Board is a college of peers with equal power.

Speaker 2

And there had been a lot of significant investor outreach. Business. The company is doing an awful lot of change internally at a management level addressing a lot of The concerns that investors I think have been raising for quite a number of years and certainly concerns that I have heard. And the Board actually said, well, we need to think about governance and are we changing as well. And I can tell you that all of the discussion, to All concerned one thing and that is what is right for Biogen.

Speaker 2

And I found that very encouraging. Business. But we have a new chair. And I have to say, I couldn't be happier working with Carolyn. She's someone of unimpeachable integrity, Extremely smart, analytical, but really has a real passion for the mission of the company.

Speaker 2

Business. And I think the Board is clearly Foursquare behind all of the changes that we're making. So I think all of that is good. In terms of disclosure, We look at people. We don't look at their personal relationships.

Speaker 2

And I would just say that Glass Lewis and ISS recommended Susan Langer and investors voted her under the Board. And I don't think there's really anything more to be

Speaker 1

business. Thank you, Chris. Can we move to our next question, please?

Operator

Business. We have a question from Salveen Richter with Goldman Sachs.

Speaker 10

Thank you. Good morning. How is the fit for growth and your cost alignment work influenced your thoughts on M and A and BD? And you've noted the 3 disease areas, but can you just provide some thoughts on the value proposition across the areas, any limits with regard to size of a deal and the use of equity. Thank you.

Speaker 2

Business. Fit for Growth, remember, is really reflecting the transition of the company. Business. We have been very focused on multiple sclerosis over 45 years. We had some very prosperous times in the more recent history of the company.

Speaker 2

And as we have seen a reversal of fortunes in some of those products, I don't think business. We as a company have really made the changes in our organizational structure and our cost base to really reflect that transition. Business. One of the things I'd like to tell our management teams is that the hardest word in management is and. Business.

Speaker 2

You have to think about the short term and the long term, but one of the things is you have to be cost efficient and you have to invest for growth. And business. And that's been a very tricky exercise. If we didn't have all the product launches, just cost reduction would be fairly easy. What We've had to do is be a lot more thoughtful about what is the best way to position Biogen going forward.

Speaker 2

And that's why we didn't start with where we were, business. But we started with where we want to be. What is that organization? How many people? We benchmarked the organization.

Speaker 2

We've looked at the making sure that we have enough investment and the product launches have enough investment in those exciting R and D projects that we didn't want to focus on and then work backwards from there. So I think the company is well positioned now to be oriented towards growth, while also managing business. Our historic portfolio and again, I come back and saying we are still the market leaders in MS and we have an obligation business. To both physicians and their patients on that. And so we will be changing the way we the promotional mix, business.

Speaker 2

We're not going to just walk away from that either. And I think in terms of M and A and external growth business. What do we do to build on that? And that starts with BD at an earlier stage of the pipeline. Are there things that we want to build on to that?

Speaker 2

And in particular, as I've said in the past, I think we're proud of our position in neuroscience. The neurological business. Conditions are slow progressing diseases and really require very expensive long trials. And business. There are ones where you can't really de risk them with a Phase 2 asset.

Speaker 2

So we're not going to walk away by any means, but we do need to get into portfolio decisions where we can actually get a better read on efficacy and safety in Phase 2. And I think we can do that with the rare diseases with more of a focus on immunology. If you know, business. We've never been far from immunology in the history of the company. And of course, with we already are in neuropsychiatry and can we build that portfolio.

Speaker 2

But I think business. We have now a much more nimble structure, a more empowered organization. One of the things that comes out of our culture surveys is that business. We can take quite a long time to make a decision. So in all of those things, when you're dealing with partners and you're dealing with business development, you want to have that business, that business.

Speaker 2

Growth is more strategic and how we shape the portfolio of the company.

Speaker 1

And limits to size or use of equity Part of the question, Chris.

Speaker 2

I think we're really looking at what really makes sense for the company. Business. I don't think we've seen anything that would require use of equity. And Mike, we've got, I think, about 7 $300,000,000 in cash. So as far as I'm concerned, we don't everything that we think we can manage with what we've got.

Speaker 2

The most important thing is to really

Speaker 11

one of

Speaker 2

the major things we tried to do with Fit for Growth is really get a lot more business. We've had this very good fortune over the last few years and when there's a lot of money in the company, business. Don't have the same rigor about how you allocate capital. That is a real focus for us. We really want to make sure that we're putting our investments in the things that make the best returns for the company and our shareholders.

Speaker 2

And so that part is a cultural shift that's coming out of that and I think that will affect how we think about business development as well.

Speaker 1

Great. Next question please.

Operator

We'll go next to Michael Yee with Jefferies.

Speaker 11

Hey, guys. Thank you. Just wanted to ask on the zuranolone program. Obviously, you have PDUFA date coming up. But Chris, you've made some pretty bullish comments on this before.

Speaker 11

Maybe right size your expectations about how to think about that opportunity And whether there could be a split label and importantly since you're talking about cost cutting, how a positive approval or maybe some various form of business. Two different indications could impact expenses going forward. So just talk a little bit about SureAnalog. Thank you.

Speaker 2

Business. Yes. Well, we have a PDUFA date on August 5. So we'll be able to give you a full update business. Once we've had the FDA decision, so I don't really want to talk about that process right now.

Speaker 2

Business. I'll just say that there is an enormous unmet need in health and that only seems to be rising. You can't look at The news without reading about reports of the rise of mental health conditions, I think that partly got exacerbated by the pandemic. Business. And one of the things is that, that is that the pandemic did was I think really bring this more out into the open where it belongs.

Speaker 2

Business. Certainly, PPD is a huge unmet need, massive taboo around that. And that will be quite a heavy lift actually because it's not really There isn't really a clarity around who really is responsible for diagnosing and treating business. In the mothers at that point. And so we look forward to being able to hopefully contribute to that.

Speaker 2

But there is a significant need also in the way it's treated. I think something business. That could act much faster than current treatments, something that's perhaps episodic could be of great value to patients. So I do think there is an opportunity, but again, we need to wait for the FDA decision and we'll fully update everybody at that point. Business.

Speaker 2

Thanks, Chris. Can we move to our next question, please?

Operator

Yes. Our next question comes from Tim Anderson with Wolfe Research.

Speaker 12

Thank you. I know that Biogen and E site continue to talk up business. The need to dose Alzheimer's drugs or lukembe specifically chronically and not just for a finite period. And you're talking about protofibrils and how they're the most neurotoxic species and that sort of thing. From what I understand, business.

Speaker 12

The science is really thin that says you need to dose chronically in the soluble forms of Abeta really make a difference in terms of continued disease progression. And empirically, if we just look at what came out of AIC, we see a similar level of reduction and improvement business. In cognition with finite dosing with denanumab and we see continued curve separation with Lilly's product and your product. So doesn't that potentially call into question the need for chronic dosing? And isn't that possibly a risk call, which will lead to a very different revenue opportunity for Lekembi.

Speaker 12

Thank

Speaker 2

you. Doctor. Singhal?

Speaker 3

Thank you for the question. Yes, this is a very important area of query and scientific hypothesis. So maybe before I really talk about lekembi or denanumab, we can agree that Alzheimer's disease is really a progressive business. And eventually fatal condition with obviously neurodegeneration involved along the way. And what we've seen with lekembi and actually multiple lines of evidence outside of lekembi, also with aducanumab in the past, business is that when you clear plaque, it does not reaccumulate that easily, but what you do see is progression of disease and you see an impact on the fluid biomarkers.

Speaker 3

So with lekembi and with the gap period that we had in Phase 2, business. We saw an increasing or the reversal of the A beta 42 to 40 ratio, implying that disease continued to progress. We saw very similar evidence with aducanumab. And I think what we see now with the plasma p Tau business. In the past, we saw with aducanumab sort of decreasing with the IMerge data set and with Lekenli, what we've seen business.

Speaker 3

With PTAU-one hundred and eighty one is a stabilization. And actually, if you saw the dananomab data on P-two seventeen, which was the plasma tau business. Biogen's and these track really quite closely is that you see a slight increase. So I think we We still need to understand with more data transparency the dunanimab data of what really happens to patients business. We stopped at 6 months or stopped at 1 year.

Speaker 3

And we hope we'll see more of that data from their open label extension and be able to draw conclusions. But when you look at the substrate for the nanomab, it really does not make sense to continue to dose. 1, because of substrate exhaustion And 2, because of the presence of antidrug antibodies close to about 84% to 87%, whereas with lekembi, You have the opportunity to have an individualized treatment duration discussion between the patient and the doctor business. Because actually it continues to impact soluble substrate as Chris mentioned and we are going to be generating data to actually look at this in a very systematic way with the Phase 2 open label extension. So I think that the jury is out, But the multiple lines of evidence do not seem to indicate that you can stop and reverse Alzheimer's disease.

Speaker 3

Business. So that's it. I'll leave it. Thank you.

Speaker 1

Thanks, Priya. Next question please, operator.

Operator

Business. We'll go next to Evan Sigerman with BMO.

Speaker 2

Hi guys. Thank you for so much. Thank you so much for taking my question. So now that you've talked through some of the rightsizing you plan on doing and now you're focusing on BD on the back half of the year. Can you talk about how you think about the value that still exists for BD in the market today.

Speaker 2

And are you focused on really near term revenue opportunities to grow the business or earlier stage development items? Thank you.

Speaker 1

Business. Well,

Speaker 2

it's quite interesting. You say today, business. When I talk to bankers, it's interesting. I think if you've got something that has really good data business. There tends to be a price for that, and that price is more or less constant.

Speaker 2

I was asking bankers, business. Do you think Mark would have had to pay even more for Prometheus, for instance, 2 years ago when business. That's kind of the go go days of biotech. And their view was no. And so I think if you find quality assets out there business.

Speaker 2

And that really doesn't vary that much. What does vary is all the other stuff, right? You got a little bit more interest in more speculative things and that's what really sort of says, well, are things relatively expensive or not. And as a company, I think I always like to say our investors to make them rich and not someone else's shareholders. So business.

Speaker 2

If you're going to do a deal, you have to make sure that there is value creation for Biogen and its shareholders. And that's a hard thing. And we all know that A lot of BD doesn't do that. The way I look at Biogen, We've got had now the decision on the lekembi. We have a pending decision at the FDA business.

Speaker 2

For zuranolone, we've got pending decisions, only can be around the world. If you look at Biogen over the next 2, 3 years, There's an opportunity for a return to growth over that timeframe. I think we are making Some bold moves here to address our cost base and really reposition our resources in the company. And business. We have I think some super interesting products in our research and development pipeline that Priya mentioned.

Speaker 2

So if you look at it, business. We already have a value creation story. So anything that we're going to do has to be accretive to that picture. And you do have to go look business. And you're going to have to go look at 100 things before you find something that really works.

Speaker 2

And that's what our teams are doing. Business. The worst thing you can do is fall in love with something, because then you lose the you lose your objectivity. Business. I can tell you that we are laser focused on changing the trajectory of our share price.

Speaker 2

As I've heard from so many investors, our share price hasn't really moved in business. 10 years. So that's where we are focused on really driving, being much more focused on shareholder value and that means Allocating capital in a way that's commensurate with that.

Speaker 1

Thanks for the views, Chris. Next question, please. Business.

Operator

The next question comes from Amy Fadia with Needham.

Speaker 3

Hi, good morning. Thanks for taking my question. Maybe a bit of a follow-up on the last topic. Business. It sounds like in the context of the FitCo Growth initiative, business.

Speaker 3

Does it mean that from a BD perspective, you're unlikely to do a deal that's a significant lift from an R and D perspective over the next couple of years? And also, if you could provide some color on how you anticipate gross margin to evolve business. Between 2023 2025, that would be helpful. Thank you.

Speaker 2

I missed part of that business. Does that mean on the BD that we would not do something I couldn't I didn't could you repeat the question?

Speaker 3

Business. Sure. Does it mean that you would not do a deal?

Speaker 10

The first one.

Speaker 3

Yes, that you would not do a deal that Is a significant heavy lift from a R and D perspective over the next couple of years?

Speaker 2

Business. So I think we have enough heavy lifting to be honest. So I'm certainly looking at things that business. I think to me, it's less around the expenditure as how much risk you're taking. Business.

Speaker 2

What I find hard is when we have a multi business. 5 year type Phase 3 study that's essentially proof of concept. That's I think what we're really trying to move away from. Now what I would say though is business. We are clearly benchmarking, and I really want us to be rigorous on G and A.

Speaker 2

I want us to be competitive business. On the sales and marketing, on R and D, I want us to be super disciplined on Capital. But I would say, all the benchmarking we've done is that Biogen has actually been better than average on productivity. Business. I do believe greatly in a lot of the capability within Biogen.

Speaker 2

And so I do think if there are things that really make sense, I actually have a higher degree of trust in our R and D organization that I think that we should continue to in R and D. The really important thing is that you really think secret about R and D is you have to design a killer experiment. Define what the criteria are for moving into the next stage and don't allocate capital unless you really meet those data. The problem in a lot of organizations is we fall in love with something. The data aren't quite clear, but we'll go and keep going business.

Speaker 2

Because we have it. And I think the discipline to kill stuff that doesn't meet its milestones is something that is Probably more important than anything else to managing R and D investments. And that's why I'm grateful to have Priya because I think Priya is extremely objective on this. Business. We all are.

Speaker 2

But again, I do think that we are an innovative company and I wouldn't want to restrict too much business. Biogen's ability to invest in R and D over time, but we're going to be extremely tough on what it is that we're going to choose to develop.

Speaker 4

Then maybe, Ami, on the gross margin line in terms of how we expect that to evolve, we said in our prepared remarks that we do expect to see our cost of sales as a percentage of revenue to continue to increase throughout the rest of 2023, and that's pretty heavily tied to business. The outsized contract manufacturing revenue that we're seeing this year. And without guidance. Guiding beyond 2023, I can just say trend wise, when you look at some of our bigger ticket items, we've got the anti CD20s, which are highly profitable. They're kind of business.

Speaker 4

Flat to somewhat declining has kind of been the trend there. You've got Tecfidera where you've got generic competition in the U. S. Obviously, we do have legal protection through the early part of 2025, but that's a high margin product as you know. And so when you look at the growth trajectory of those products versus the contract manufacturing, and we will continue to be business.

Speaker 4

Aggressive in pursuing contract manufacturing opportunities if we can utilize them to fill space that we otherwise wouldn't use. Business. You would expect that we would continue to see some pressure on the gross margin percentage. That's something that we'll manage. We are seeing we did have $34,000,000 of idle Capacity charges during the quarter.

Speaker 4

That is something that we hope will abate over time as Leketmi ramps up and we're able to fully utilize our facility in Solaturn. So that would be potentially an offset. But business. We don't see real material increases in our gross margin percentage, so that's something we're going to have to manage. And that's part of the reason why we put such key focus on our operating expenses and introduce such a meaningful cost reduction program.

Speaker 1

Great. Thanks, Mike. Next question, please. Business.

Operator

We'll go next to Brian Skorney with Baird.

Speaker 13

Hey, good morning, everyone. Thank you for taking my business. Really just one, you guys had a role in developing both Lechembe and Aduhelm. And one of the things that seems to be jumping out is sort of the differential profile of these drugs in business. But seeing that those differences despite very similar plaque removal, so I guess there's a lot of speculation and maybe remains a lot of uncertainty as to the underlying mechanism.

Speaker 13

But anything you can say in terms of sort of your thought process about how much of this may be sort of subspecies business. Target driven, how much of it may just be sort of a matter of PK? I mean, it seems like the comments on subcu indicates at least some of it may be GMAC driven, but just how are you guys currently thinking about the mechanism underpinning the ROE?

Speaker 3

Business. Yes. Thank you, Brian. So overall, I think we don't fully understand the mechanism of ARIA, business. But the data have been replicated for lekembi in terms of the low incidence of diarrhea business.

Speaker 3

In the sense that when you compare it with some of the other anti amyloid, anti beta amyloid antibodies, it is significantly lower and replicate it twice. So for example, in the CLARITY AD study, we had an ARIA E rate of about 12.6%, business. But with dolanumab, we see an ARIA E rate of 24% and very similar sort of proportions with ARIA H. Business. So I think that it also depends on the population that has been recruited.

Speaker 3

And as Chris mentioned, these populations have been slightly different business. With MCI being and the early population because we really believe that patients need to be treated earlier. So that could be playing a role. But I think overall, it's very hard to assess exactly what may be driving the differential base. Business.

Speaker 3

What I think we can say is that the observation that the incidence is significantly different and therefore I believe that the benefit risk is also different. And that I think is what doctors should be looking at. Couple that with the efforts It's pretty much circumscribed to the 1st 6 months. There's no titration, so we see the rates that we do. And then it really peters off completely.

Speaker 3

Business. And recurrence is very, very low. This helps us because we can help physicians really get on board, business. Stay on the monitoring plan and that is really the focus of each side with better understanding of the program. So I think overall, we have to look at the benefit risk.

Speaker 3

We've got the broad AB population that did not recruit via tau sub stratification for lekembe business. And we have the results right up to Taupept because everybody, as you know, amyloid kind of progresses into the neurofibrillary tangles. And so it's really helpful to understand that there is a broad application with lekembi and then there's a risk profile that's also business. I think we do have a boxed warning as you know with the APOE4 patients

Speaker 1

business.

Speaker 2

And one of the things Priya that I was business. So, Lynn Kramer and Priya, over the weekend, got through this super interesting paper about business. All that happened at the AIIC and the differences and the thing that struck me is just really how complex this is and business. How much there is to really analyze and understand. But one of the things that struck me was that there is a difference in safety, not just in the broad population, But we see that in every subgroup too.

Speaker 2

I mean,

Speaker 3

if you're

Speaker 2

looking at the APOE group, heterozygous, homozygous, there's a difference. And business. And if these drugs were similar, you wouldn't expect such a dramatic difference. I mean, we're talking about, in some subgroups, it can be as much 3:one ratio on the safety. And that's why I think we're going to spend an awful lot more time analyzing what's really going on here.

Speaker 2

That's what I said at the outset. We're really just at the start of this. There's still so much we don't know, but this is going to generate an awful lot business. And we're going to start digging into this and understanding all of these different subtleties that are there. But I think these differences are going to be quite important.

Speaker 2

As Priya said, the jury is still out on that, but we have an awful lot of signs about what's really going on here. And that's why business. As a company of Biogen, we don't see the launch of Lekembia as the end to our commitment to Alzheimer's. As Priya pointed out, we have other programs in Alzheimer's and we're going to be continuing to do research because it is really our ambition to be along with our partners Eisai, the absolute leader in what we think is going to be an extremely significant market.

Speaker 1

Business. Great. Thank you for the insights. Next question please.

Operator

Next question comes from Chris Schott with JPMorgan.

Speaker 14

Great. Thanks very much for the question. I just wanted to appreciate all the color on the call, but I just wanted to come back to the lekembe and kind of ramp from here. Business. I know you've talked about this being kind of a gradual process, but based on the early feedback you've had from the market with the launch, I guess any incremental color of is this either going fast business.

Speaker 14

Or slower than you might have anticipated. And maybe just as part of that, what have been the biggest kind of positives or negatives on the rollout so far as we just try to kind of better assess how business.

Speaker 2

Well, as to what you anticipate, it's kind of hard. As I say, business. This is only the 2nd time in my career where I've actually seen a brand new therapeutic area actually open up. And so when you think about Alzheimer's patients and visiting neurologists, beyond cognitive tasks and as I say, perhaps prescribing business. The anticholinergics like Dinepizil hasn't really been much to do.

Speaker 2

And now we do have a treatment and This is going to upend a lot of the processes within neurology practices. It's extremely exciting. But really business. The uptake is geared on how prepared are the sites. And this is variable around the country.

Speaker 2

You've had some business. Obviously, they've been involved in clinical trials. Some of them have different patient populations and we see business. Some sites are quite advanced and are ready to go. Some sites have been more in the wait and see mode, And I think we're all ramping up.

Speaker 2

One of the things that we have been doing is really Trying to figure out where the sites that are really ready and actually deploying our resources to those sites business. With then a secondary type of approach to sites that aren't quite ready and helping them. So it all depends on really how advanced the sites How ready they are that it's really going to define the uptake. And that's why we have to target our resources to that and really business. That's the site activation, if you like.

Speaker 2

But so far, we're getting a lot of positive feedback. Business. Physicians are getting a lot of inquiries from patients. I think they will have to figure out exactly what's the right patient for this and that's where we have to do a lot of education and we have these online programs and other programs to help educate physicians. There's a a significant amount.

Speaker 2

I mean, you just talk about what we've been talking about in terms of these protofibrils, about the different patient business. All of those things are going to engage the whole neurology community here. But so far, business. Everything is as far as we're concerned, the launch is going to plan.

Speaker 1

Thanks, Chris. And if we could just take our last question, operator.

Operator

Business. Our last question comes from Paul Matteis with Stifel.

Speaker 15

Business. Hey, thanks so much for taking my question. I wanted to just briefly come back to zuranolone. I've been really surprised by the lack of discussion on the call and the prepared remarks Compared to prior calls, can you just am I overly reading into this? I guess you're gearing up for potentially a new antidepressant approval.

Speaker 15

And Chris, at one point you called this your most undervalued asset. So are you as bullish on this drug as you were before? And I guess if you didn't get the MDD approval, but only got PPD, how would Biogen execute on that opportunity? Thank you.

Speaker 8

Business. Look, we're in late stage review. So I

Speaker 2

think it's pretty normal that we don't want to disturb that process. And business. We obviously don't want to say anything that affects the FDA. I I have to confess to a little bit of superstitiousness on my side. I mean, I just I'd like to see the FDA decision and then we'll be happy to talk lots about it.

Speaker 2

But business. The opportunity is huge out there, Paul.

Speaker 1

Thanks, Chris, and thanks everybody today for joining. Business. This

Operator

does conclude today's conference call. Thank you for your participation. You may now disconnect.

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Earnings Conference Call
Biogen Q2 2023
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