Q4 2022 Biogen Inc Earnings Call

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Operator: Good morning. My name is Katina, and I will be your conference operator today. At this time, I would like to welcome everyone to the Biogen fourth quarter and full year 2022 earnings call and business update.

Operator: All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star one on your telephone keypad.

Operator: Please limit yourself to one question to allow other participants time for questions.

Operator: If you require any further follow up, you may press star one again to rejoin the queue. Thank you. I would now like to turn the conference over to Mr. Mike Hencke, head of investor relations. Mr. Hencke, you may begin your conference.

Michael Hencke: Thank you good morning, and welcome to Biogen's fourth quarter and full year 2022 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'll discuss today. 

Our GAAP financials are provided in tables one and two and table four includes a reconciliation of our GAAP to non-GAAP financial results. We believe non-GAAP financial results better represent the ongoing economics of our business and reflect how we manage the business internally. We've also posted slides on our website that follow the discussions 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.

Our GAAP financials are provided in tables one and two and table four includes a reconciliation of our GAAP to non-GAAP financial results. We believe non-GAAP financial results better represent the ongoing economics of our business and reflect how we manage the business internally. We've also posted slides on our website that follow the discussions 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.

<unk>, 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. On today's call, I'm joined by our President and Chief Executive Officer, Christopher Viehbacher, Dr. Priya Singhal, head of development and our CFO, Mike McDonnell. As a reminder, during the Q&A portion of the call, we kindly ask that you limit yourself to one question. I'll now turn the call over to Chris.

I encourage you to consult the risk factors discussed in our SEC filings for additional detail.

On today's call, I'm joined by our President and Chief Executive Officer, Christopher Viehbacher, Dr. Priya Singhal, head of development and our CFO , Mike McDonnell. As a reminder, during the Q&A portion of the call, we kindly ask that you limit yourself to one question. I'll now turn the call over to Chris.

Yes.

Christopher A. Viehbacher: Thank you Mike. Good morning everybody, and thanks for joining us. It's a pleasure to welcome you here today. This is my first earnings call since joining Biogen.

This is my first earnings call since joining Biogen.

Clearly, Biogen has a strong legacy as one of the pioneers in biotechnology and there's clearly a strong foundation to build upon. Equally, there is an urgent need to restore growth to the company. We have a great opportunity ahead with the potential launch of two important near term launches with Alzheimer's and depression, and we have several pipeline programs. We'll be covering a lot more about how we intend to return to growth. But first, I'd like to turn this over to Mike and invite Mike to provide an overview of the fourth quarter and full year financial results.

Equally there is an urgent need to restore growth to the company.

We have a great opportunity ahead with the potential launch of two important near term launches with Alzheimer's and depression, and we have several pipeline programs. We'll be covering a lot more about how we intend to return to growth. But first, I'd like to turn this over to Mike and invite Mike to provide an overview of the fourth quarter and full year financial results.

It will be covering a lot more about how we intend to return to growth.

But first I'd like to turn this over to Mike and then Mike to provide an overview of the fourth quarter and full year financial results.

Michael R. McDonnell: Thank you Chris and good morning everyone. So I will provide some highlights of the financial performance for the fourth quarter and any financial comparisons that you hear me make will be versus the fourth quarter of 2021.

Our total revenue for the fourth quarter was $2.5 billion and that's a decrease of 7% at actual currency and 4% at constant currency.

Non-GAAP diluted EPS in the fourth quarter was $4.05 and that's an increase of 19% versus the fourth quarter of 2021.

Versus the fourth quarter of 2021.

MS product revenue was $1.3 billion and that's a decrease of 17% at actual currency and 14% at constant currency and this decline was primarily due to the impact of Tecfidera Generics as well as continued declines in the interferons and some pricing pressure.

We have continued to see a number of the Techfidera Generics launch across multiple European countries, and we expect a decision from the European Court of Justice related to our market protection by March 16th of this year.

Separately, we do continue to enforce our recently granted European Tecfidera dosing patent, which expires in 2028.

We also continue to enforce our IP for Tysabri. We have sued ProPharma and Sandoz to enforce those rights so that move for a preliminary injunction against the launch of Sandoz and ProPharma's biosimilar in the United States.

Regarding potential supply constraints for VUMERITY, we believe that we have resolved previously reported manufacturing issues at our contract manufacturer. We're currently in the process of securing regulatory approvals for a secondary source of supply and we do not anticipate a supply shortage in 2023. 

In 2023.

Okay.

Moving now to SMA, global SPINRAZA revenue was $459 million and that's a 4% increase at actual currency and 10% at constant currency. In the United States, SPINRAZA revenue increased by 5% versus the prior year and we continue to believe that we may be seeing signs of stabilization.

United States been Rozzer revenue increased by 5% versus the prior year and.

And we continue to believe that we may be seeing signs of stabilization.

Outside of the US, revenue increased 4% at actual currency and 12% at constant currency with continued growth primarily in our Asian markets and that was partially offset by competition in Europe.

With continued growth primarily in our Asian markets and that was partially offset by competition in Europe.

Biosimilar's revenue was $175 million and that's a 21% decline at actual currency and 15% at constant currency, and that's due to continued pricing pressure and some net pricing adjustments during the quarter.

And that's due to continued pricing pressure and some net pricing adjustments during the quarter.

Total anti-CD 20 revenue of $448 million was up 8% versus the prior year. Revenue from [inaudible] royalties increased 19%, which was partially offset by a revenue decline of 14% related to our profit share on Rituxan. The Rituxan decline was due to Biosimilar competition.

Versus the prior year revenue from <unk> royalties increased 19%, which was partially offset by a revenue decline of 14% related to our profit share on rituxan.

The Rituxan decline was due to biosimilar competition.

Yes.

Yeah.

Regarding expenses for the fourth quarter, non-GAAP cost of sales was $571 million, which is 22% of revenue and that includes $36 million of idle capacity charges. [inaudible] share of these charges is reflected as part of the collaboration profit sharing line and that is not part of cost of sales.

<unk> share of these charges is reflected as part of the collaboration profit sharing line and that is not part of cost of sales.

Fourth quarter, non-GAAP, R&D expense was $602 million and this compared to $700 million in the fourth quarter of 2021 included approximately $110 million in payments related to some business development transactions.

In the fourth quarter of 2021 included approximately $110 million in payments.

Related to some business development transactions.

Non-GAAP SG&A was $632 million and this compared to $785 million in the fourth quarter of 2021. And this decrease in SG&A expense was driven primarily by our previously announced cost savings initiatives.

And this decrease in SG&A expense was driven primarily by our previously announced cost savings initiatives.

Okay.

We remain on track to achieve our previously announced $1 billion in cost savings initiatives. And I'll comment on this a bit further when I discuss our guidance for 2023.

And I'll comment on this a bit further when I discuss our guidance for 2023.

As for our balance sheet, we ended the quarter with $5.6 billion in cash and marketable securities. We had $6.3 billion in debt and roughly $700 million and net debt. And as a reminder, we expect to receive an additional $1.25 billion over the next 15 months from the sale of our equity stake in Samsung [inaudible]. And that includes approximately $813 million, which is due in April of this year. So overall, we remain in a very strong financial position with significant cash and financial capacity to invest in growing the business over time.

We ended the quarter with $5 6 billion in cash and marketable securities.

We had $6 3 billion in debt.

And roughly $700 million and net debt and as a reminder, we expect to receive an additional $1 $25 billion over the next 15 months from the sale of our equity stake in Samsung <unk>.

And that includes approximately $813 million, which is due in April of this year.

So overall, we remain in a very strong financial position with significant cash and financial capacity to invest in growing the business over time.

Later in the call, I will discuss our guidance assumptions as well as some important accounting considerations for 2023, but for now, I will turn the call back to Chris.

Christopher A. Viehbacher: Thank you Mike. So Biogen has recently celebrated its 45th anniversary and this is a company that has really been built on multiple sclerosis. It had some hemophilia products until it was spun off as [inaudible], some of you may recall that in the past and we have SPINRAZA. So now we really need to think about how do we transform the business.

Customers here.

So.

Biogen has recently celebrated its 45th anniversary and this is a company that has really been built on multiple sclerosis.

It had some hemophilia products.

Until it was spun off as <unk>. Some of you may recall that in the past and we have spin Rosa.

So now we really need to think about how do we transform the business.

I know firsthand from talking to a number of neurologists that our products in MS are still considered to be the top products, but obviously this is becoming a much more competitive environment. Therefore, we really need to think about how do we grow the business in the future.

Therefore, we really need to think about how do we grow the business in the future.

Now, we have an amazing opportunity with two new products. As many of you know, I've been in this business a long time and it's pretty rare that you have this opportunity to launch not one but two major products and not just any products, but products that are really quite transformative in their respective therapeutic areas, and that's obviously the [inaudible]. We also have existing products we can still grow the VUMERITY, we can still grow SPINRAZA and I think we need to take a fresh approach to those and try to reinvigorate the growth of those two brands.

<unk>.

As many of you know I've been in this business a long time and it's pretty rare that you have this opportunity to launch not one but two major products and not just any products that products that are really quite transformative and their respective therapeutic areas and thats, obviously that can be enduring alone.

Also have.

<unk> products, we can still grow the minority we can still grow spend raza and I think we need to take a fresh approach to those and try to reinvigorate the growth of those two brands.

As many of you will point out to me, Biogen has a cost base that is probably higher than most of its peers and we need to think about that much more systematically and some of that may require a reduction in costs, some of it is actually a realignment with the new growth alternatives.

Biogen has a cost base that is probably higher than most of its peers.

Need to think about that much more systematically and some of that may require a reduction in costs. Some of it is actually a re alignment with the new growth alternatives.

And then we also need to look at the R&D pipeline. We don't get very much credit for what we have in R&D and Priya is going to talk to you about a number of different products that we think have an awful lot of potential.

A number of different products that we think have enough a lot of potential equally.

Equally, the neurology franchise [inaudible] slowly progressing diseases. That means you're automatically into long term and costly clinical studies. And in addition, we have some projects in there where our phase III studies are essentially proof of concept studies and so that makes them also inherently riskier, and I think we need to think about how do we balance the pipeline in R&D going forward.

Slowly progressing diseases that means youre automatically into long term.

And costly clinical studies.

And in addition, we have some projects in there where our phase III studies are essentially proof of concept studies and so that makes them also inherently riskier than I think we need to think about how do we balance the.

The pipeline in R&D going forward.

And finally, I think we should always be--any company should always be open to thinking about external growth opportunities. This hasn't always been a major trust company in the past, but I do think that as we expand into other areas such as immunology, rare diseases, psychiatry that there may be opportunities to bolster those franchises through external growth.

It hasn't always been a major trust company in the past.

But I do think that.

As we expand into other areas such as immunology rare diseases psychiatry that there may be opportunities to bolster those franchises through external growth.

So as you know, [inaudible] has received accelerated approval in the United States in early January. We have on the same day filed for a full or traditional approval. And I have to also give credit to our partner Eisai because within a very short period of time, not only did they file for traditional approval on the same day as receiving accelerated approval, but also within weeks they have filed in Europe and Japan and initiated a rolling submission in China.

We have on the same day filed for a full or traditional approval.

And I have to also give credit to our partner <unk> because within a very short period of time.

Not only did they file for traditional approval on the same day is receiving accelerated approval, but also within weeks they have filed and in Europe, and Japan and initiated a rolling submission in China.

And obviously in the short term, the launch in the US is really going to be constricted until we get reimbursement and that's expected to occur once we have a traditional approval. When we get confirmation of filing from the FDA, at that point, we will know whether we have a priority review or not.

Obviously in the short term the launch in the U S is really going to be <unk>. Strict it until we get.

Strict it until we get.

Reimbursement and that's expected to occur once we have it.

Traditional approval.

When we when we get confirmation of filing from the FDA at.

At that point, we will know whether we have.

A priority review or not.

Under the terms of the agreement, Eisai is principally responsible and leads all of the discussions with CMS. As many of you probably have heard, Eisai has said that they are hoping to receive a broader reimbursement once they get traditional approval and that could be as early as this summer.

As many of you probably have heard ASI has said that they are hoping to receive.

A broader.

Reimbursement once they get traditional approval and that could be as early as this summer.

But as you know, this is not a round white pill that we're launching here. You need to have a pet scan or a lumbar puncture to confirm diagnosis. We're going to have infusion capacity restrictions. Neurologists have already been busy treating patients with other conditions so there will be a question about do we have enough neurologist to expand the patient population, and so there's an awful lot to be done in the near term.

You need to have a pet scan or a lumbar puncture.

To confirm diagnosis, we're going to have infusion capacity.

Restrictions.

Neurologists have already been busy treating patients with other conditions.

So there will be a question about do we have enough neurologist 52.

Expand the patient population.

And so there's an awful lot to be done.

One of the questions that comes up is--And that will be the main discussion for CMS, to me, the CVR sum of boxes is not really how we look at patient benefit here as. As I talk to physicians treating Alzheimer's patients, most of them are really asking can I still drive a car? Can I feed myself? Can I dress myself? Can I enjoy life with my family? And how can I not be a burden to others? And when you actually look at the activities of daily life, we actually saw a 37% improvement versus placebo. And to me, that's where the real benefit of this product is.

One of the questions that comes up is.

And that will be the main discussion for Tms.

To me.

The sum of boxes, the CVR sum of boxes is not really how we look at at patient benefit here as.

As I talk to physicians treating Alzheimer's patients.

Most of them are really asking can I still drive a car can I feed myself can I address myself can they enjoying life with my family and how can I not be a burden to others and when you actually look at the activities of daily life, we actually saw a 37% improvement versus versus placebo and to me.

That's where the real benefit of this.

Now, as we look at Alzheimers, the other message I think I would really like to drive home today is that this is not just a product launch. There is a today and there is a tomorrow. And certainly today, everybody is going to be focused on the initial sales of [inaudible], and that's going to be a question of overcoming some of the the infrastructure challenges that we just talked about. There's going to be an awful lot of education of physicians around safety, around the diagnosis and the infrastructure has to expand to be able to provide the pet scans of the CSF testing. This is really opening up a whole new field. This is a whole new Vista both for patients and physicians.

No.

As we look at Alzheimers.

The other message I think I would really like to drive home today is that this is not just product launch.

There is at today and Theres a tomorrow.

And certainly today, everybody is going to be focused on the initial sales of <unk> can be.

And thats going to be a question of overcoming some of the the infrastructure challenges that we just talked about there's going to be an awful lot of education of physicians around safety.

and the infrastructure has to expand to be able to provide the pet scans of the CSF testing. This is really opening up a whole new field. This is a whole new Vista both for patients and physicians.

And the infrastructure has to expand to be able to provide the pet scans of the CSF taste testing. This is really. This is really opening up a whole new field. This is a whole new Vista. Both for patients and physicians.

This is really. This is really opening up a whole new field. This is a whole new Vista.

This is really opening up a whole new field.

This is a whole new Vista.

Both for patients and physicians.

I can remember 10 years ago, where we had a lot of failures of medicines in development to reduce amyloid, people had given up hope that this was going to be effective. Actually it was Biogen's Prime study that was initiated about 10 years ago that actually showed that there was still hope for this and of course, it's really the clarity study that has really demonstrated the importance of removal of plaque and the potential to impact the decline in cognition. And what I think this is going to do is unleash a whole wave of research and development, but there could be other things, I mean, just even things that we're doing. 

Actually it was biogen's Prime study that was initiated about 10 years ago that actually showed that there was still hope for this and of course, it's really the clarity study that has really demonstrated the importance of removal of plaque and the potential to impact the decline in cognition and I think this is going.

Do has unleashed a whole wave of research and development, but there could be other things I mean, just even things that we're doing.

Yes.

Obviously, there's amyloid, but they're going to be other modalities such as Tau. And Priya will talk about our own potential solution in terms of Tau. But we're also looking at this. The trial really focused on this 18 months of treatment, but what happens at the end of the 18 months? And there are actually already data that indicates staying on drug has a continued benefit. And so in fact Eisai will be filing before the end of Q4 this year an indication for the treatment on a maintenance basis.

And <unk> will talk about our own.

Potential solution in terms of talent, but we're also looking at this.

The trial really focused on this 18 months of treatment.

So what happens at the end of the 18 months and there are actually already data that indicates staying on drug has a continued benefit.

And so in fact ASI will be filing before the end of Q4.

This year, an indication for the treatment on a maintenance basis.

But one of the other most interesting guideline and I have been obviously trying to get up to speed on Alzheimer's over the last 90 days, but it turns out that plaque burden is at its maximum just before symptoms arise. So imagine the benefit if we could actually go earlier. And in fact, there is a study called Ahead that is looking at preclinical or pre-symptomatic patients that could be quite interesting. But to do that of course, other things like blood based biomarkers and other biomarkers are going to be important. We're going to have to make this a lot more convenient as a treatment and there are subcutaneous treatment formulations in progress. And so what I think you're going to see is just a flood of information over the next three to five years as new modalities and new ways of treating Alzheimers patients come up. 

Imagine the benefit if we could actually go earlier and in fact, there is a study called ahead that is looking at a preclinical or pre symptomatic patients that could be quite interesting.

But to do that of course, other things like blood based biomarkers and other biomarkers theyre going to be important.

We're going to have to make this a lot more convenient as a treatment in their subcutaneous treatment formulations in progress.

And so what I think you're going to see is just a flood of information over the next three to five years as new modalities and new ways of treating Alzheimers patients come up. 

And so here you see the Ahead study that was launched in 2020 looking at pre-symptomatic. One of the physicians who treated Alzheimer's told me, we used to think about Alzheimer's as a seven to eight year timeframe, which was really from the onset of symptoms until sadly death, now they're looking at this on a 25-year frame because we know that plaque builds up over time.

And looking at pre symptomatic one of the.

One of the physicians, who treat Alzheimer's totally we used to think about Alzheimer's is a seven to eight year timeframe, which was really from the onset of symptoms until sadly Def now theyre looking at this on a 25 year frame because we know that builds up over time.

And in fact, what we call early stage Alzheimer's today with this mild cognitive improvement, it's really not. It's actually already pretty advanced by the time you have MCI. We already talked about the potential for maintenance dosing and different modalities, so this is going to be quite an exciting area as we go along.

Already pretty advanced by the time you have mci.

We already talked about the potential for maintenance dosing and different modalities. So this is going to be quite an exciting areas. We all along.

Now the exciting area is major depressive disorder and there are 21 million people who suffer from this and every day you are reading about the major concerns around mental health in society. In fact, Stat just had an article yesterday about the number of younger people who are suffering from depression and feeling sad and even suicidal. And so there is a clear need for new treatments. There are over 400 million prescriptions written every year for MDD and other medical illnesses, But what we see is an awful lot of switching between therapies. There's a lot of concern around side effects. It takes a long time for these existing medicines to work, and so my personal view is there's an awful lot of unmet need. [inaudible] Glaxosmithkline when we had [inaudible] so I'm pretty familiar with what the existing treatments can and cannot do.

Major depressive disorder and <unk>.

There are 21 million people, who suffer from this.

Every day you are reading about.

The major concerns around mental health in society in fact Stat, just had an article yesterday about the number of.

Younger people, who are suffering from depression, and feeling side and even suicidal and so there is a clear need for new treatments. There are over 400 million prescriptions written every year for MDC.

<unk> and other medical illnesses.

But what we see is an awful lot of switching between therapies. There's a lot of concern around side effects. It takes a long time for these existing medicines to work, and so my personal view is there's an awful lot of unmet need. [inaudible] Glaxosmithkline when we had [inaudible] so I'm pretty familiar with what the existing treatments can and cannot do.

There's a lot of concern around side effects. It takes a long time for these new medicines to these existing medicines to.

To work and so my personal view is there's an awful lot of unmet need is at Glaxosmithkline. When we had <unk> and we had well returns so I'm pretty familiar with what the existing treatments can and cannot do.

Postpartum depression, another significant area of unmet need, one in a mother. We just had a tragic case that many of us in the Boston area are following and it just demonstrates that there is a real need for a new approach and new treatment here. And this is not necessarily where the big commercial opportunity is but there is a major societal need and I think that [inaudible] can make a big change here.

And this is not necessarily where the big commercial opportunity is but there is a major societal need and I think that's around alone can make a big change here.

So we have had a priority review granted and we have now a [inaudible] date in August. As you know, we can't launch immediately because there will have to be a review of the scheduling of the drug before we can launch so we're looking to launch more towards the end of the year.

We have had a priority review.

<unk> and we have now a <unk> date in August as you know we can't launch immediately because we will have to be a.

A review of the scheduling of the drug before we can launch so we're looking to launch more towards the end of the year.

One of the interesting things as I see this every now and then in the media about, the controversial data of Saranalone because six out of seven trials were positive. Folks, when we were developing [inaudible] years ago, we had to do six phase III studies to get two that worked. There is an incredible placebo effect here, which is why so many companies actually abandoned mental health. So when I saw six out of seven, I said, wow, this is absolutely terrific and so I think there is quite an exciting opportunity here.

Every now and then the media about the controversial data.

Saran alone because six out of seven trials were positive.

Folks when we were developing <unk> years ago, we had to do six phase III studies to get to that work. There is an incredible placebo effect here, which is why so many companies actually abandoned mental health. So when I saw six out of certain I said Wow. This is absolutely terrific and so I think there is quite an exciting opportunity here.

We're not going to clearly go after every type of patient and we're doing a lot of market research today. We're finishing the shoreline study and that will inform us about who's the right patient for this. And obviously, the label would inform who are interested but there's a lot of unresolved symptoms of depression up there. MDD patients with elevated anxiety, we won't clearly have an anxiety indication, but that is an area of MDD patients that we're going to be focusing on and those who are adherence challenged.

Honestly the label would inform who are interested but theres a lot of unresolved symptoms of depression up there. <unk> patients with elevated anxiety, we clearly have an anxiety indication, but that is it. That is an area of MTV patients that we're going to be focusing on and those who are adherence challenged.

<unk> patients with elevated anxiety, we clearly have an anxiety indication, but that is it. That is an area of MTV patients that we're going to be focusing on and those who are adherence challenged.

That is an area of MTV patients that we're going to be focusing on and those who are adherence challenged.

Coming back to existing drugs, I'll just say, obviously Biogen's had Enormous success with SPINRAZA, but when you look at it, there are still a lot of potential patients who haven't been treated, adult patients as well as pediatric patients and we're going to have a fresh look at how we prove the coverage of this product. Obviously, it's an intra fecal product, which is not necessarily the most convenient. You may have seen we've just done a collaboration with [inaudible] kind of a new device that would make this more convenient for patients who are not wanting to go through the numerous lumbar punctures.

Enormous success with spin Raza, but when you look at it there are still a lot of potential patients who have been treated.

Patients and as well as PD.

Pediatric patients and we're going to have a fresh look at how we.

Prove the coverage of this product.

Obviously, it's an intra fecal product, which is not necessarily the most convenient you may have seen we've just done it.

Collaboration with <unk> to kind of a new device that would make this more convenient for patients who are.

Not wanting to go through the numerous lumbar punctures.

We are looking at costs that is looking at the profitability of our MS franchise, can we shift some of these costs to support our new product launches. We have our biosimilars business, an important businesses as part of the way that we create the economies for the health care system before new businesses, but we are looking at whether we can do more with that business, so maybe whether others could [inaudible] on this business. We're prioritizing the near term opportunities and really looking at our cost base on a systematic basis.

New product launches.

We have our biosimilars business and important businesses as part of the way that we create the economies for the health care system before new businesses, but we are looking at weather.

We can do more with that business, so maybe whether others shown on this business.

We're prioritizing the near term opportunities and really looking at our cost base on a systematic basis.

At our cost base on a systematic basis.

Priya is going to talk about the risk profile and productivity of the R&D pipeline. As I mentioned earlier, we have appointed Priya as head of development and I'd like to take the opportunity to congratulate her on that We're also looking for a new head of research. While we have a lot going on [inaudible] we will continue to evaluate external growth opportunities. And so I think with that Priya why don't we talk about R&D.

While we have a lot going on.

We will continue to evaluate external growth opportunities and so I think without pre why don't we talk about R&D.

Priya Singhal: Thank you Chris. We are advancing [inaudible] with Eisai as a foothold in Alzheimer's disease. As you heard from Chris, [inaudible] with Sage both as key late stage assets, but also as growth drivers. With Sage, we also announced the FDA acceptance of [inaudible] as priority review. The [inaudible] date is August 5th.

We are advancing and it can be with ESI as a foothold in Alzheimer's disease. As you heard from Chris and Savannah alone with Sage bolt as key late stage assets, but also agile dry bud. Let's see. We'll announce the FDA acceptance of the Rand alone in MTBE in PPD as priority review. <unk> date is August.

As you heard from Chris and Savannah alone with Sage bolt as key late stage assets, but also agile dry bud. Let's see. We'll announce the FDA acceptance of the Rand alone in MTBE in PPD as priority review. <unk> date is August.

Let's see. We'll announce the FDA acceptance of the Rand alone in MTBE in PPD as priority review. <unk> date is August.

We'll announce the FDA acceptance of the Rand alone in MTBE in PPD as priority review. <unk> date is August.

<unk> date is August.

The priority review was granted by FDA to applications for medicine that if approved, would provide significant improvements in the effectiveness or safety of the treatment, diagnosis, or prevention of disease condition.

If approved would provide significant improvements in the effectiveness.

The safety of the treatment diagnosis of prevention of disease condition.

Beyond these developments, we're also making progress across R&D reprioritization and today, I will share a few highlights from some of our pipeline programs in Alzheimer's disease, lupus, and ALS.

Xylem disease lupus and <unk>.

We are advancing a broader Alzheimer's disease pipeline as you heard from Chris. And we have initiated the phase two study of [inaudible] in early Alzheimer's disease. Prior clinical results, including those from our own phase two [inaudible] suggest that targeting extracellular Tau alone is insufficient to affect intracellular Tau tangles. [inaudible] is targeting Tau m-RNA to reduce all forms of the Tau protein called post [inaudible]. In preclinical studies, we've seen that ASO knockdown of the Tau in the transgenic mouse model of neuro degenerative dowel [inaudible] reversed Tau [inaudible], prevented Hippocampus volume loss and [inaudible]. This year illustrates the phase one b study results of [inaudible] in mild [inaudible]. [inaudible] was generally well tolerated, and we observed a time and dose dependent reduction in CSF total and [inaudible].

And we have initiated the phase two study of <unk> AP in early Alzheimer's disease.

Brio clinical results, including those from our own phase to go through a new map suggest that targeting extracellular tau alone is insufficient to affect intracellular Tau tangles.

Dave.

<unk> is targeting Tau mrna. All forms of the Tau protein called <unk>. Medication. In preclinical studies <unk>. Seen that <unk> knockdown of the Dol and the transgenic mouse model of neuro degenerative dowell pretty robust. Geology. Hippocampus volume loss and you don't know that. Yes. This illustrates the phase one b study results in mild <unk>. <unk> was generally well tolerated. And we observed a diamond dose dependent reduction in CSF total and beat.

All forms of the Tau protein called <unk>. Medication. In preclinical studies <unk>. Seen that <unk> knockdown of the Dol and the transgenic mouse model of neuro degenerative dowell pretty robust. Geology. Hippocampus volume loss and you don't know that. Yes. This illustrates the phase one b study results in mild <unk>. <unk> was generally well tolerated. And we observed a diamond dose dependent reduction in CSF total and beat.

Medication. In preclinical studies <unk>. Seen that <unk> knockdown of the Dol and the transgenic mouse model of neuro degenerative dowell pretty robust. Geology. Hippocampus volume loss and you don't know that. Yes. This illustrates the phase one b study results in mild <unk>. <unk> was generally well tolerated. And we observed a diamond dose dependent reduction in CSF total and beat.

In preclinical studies <unk>. Seen that <unk> knockdown of the Dol and the transgenic mouse model of neuro degenerative dowell pretty robust. Geology. Hippocampus volume loss and you don't know that. Yes. This illustrates the phase one b study results in mild <unk>. <unk> was generally well tolerated. And we observed a diamond dose dependent reduction in CSF total and beat.

Seen that <unk> knockdown of the Dol and the transgenic mouse model of neuro degenerative dowell pretty robust. Geology. Hippocampus volume loss and you don't know that. Yes. This illustrates the phase one b study results in mild <unk>. <unk> was generally well tolerated. And we observed a diamond dose dependent reduction in CSF total and beat.

Geology. Hippocampus volume loss and you don't know that. Yes. This illustrates the phase one b study results in mild <unk>. <unk> was generally well tolerated. And we observed a diamond dose dependent reduction in CSF total and beat.

Hippocampus volume loss and you don't know that. Yes. This illustrates the phase one b study results in mild <unk>. <unk> was generally well tolerated. And we observed a diamond dose dependent reduction in CSF total and beat.

Yes. This illustrates the phase one b study results in mild <unk>. <unk> was generally well tolerated. And we observed a diamond dose dependent reduction in CSF total and beat.

This illustrates the phase one b study results in mild <unk>. <unk> was generally well tolerated. And we observed a diamond dose dependent reduction in CSF total and beat.

<unk> was generally well tolerated. And we observed a diamond dose dependent reduction in CSF total and beat.

And we observed a diamond dose dependent reduction in CSF total and beat.

Total TAU continued to decline 16 weeks following the last dose with a 50% reduction from baseline. We were encouraged by this early data and we look forward to sharing data details from this one b study at ADPD next month.

We were encouraged by this early data and we look forward to sharing data details from this one b study at <unk> next month.

As I mentioned, we have initiated our phase two [inaudible] study in 2022. It includes several dosing paradigm, predoses and every 12 or 24 week dosing. And assessments will evaluate multiple aspects of Alzheimer's disease cognition, function, and biomarker. We believe that [inaudible] has the potential to generate important learnings regarding the role of TAU in Alzheimer's disease.

Include several dosing paradigm.

And every 12 or 24 week dosing.

And assessments will evaluate multiple aspects of Alzheimer's disease cognition function and biomarker.

We believe that <unk> has the potential to generate important learnings regarding the role of style in Alzheimer's disease.

Moving on, Biogen has leveraged  very strong scientific expertise in immunology and this is how the MS franchise was born. I'd like to discuss our two phase III Lupus program next.

Biogen has leveraged our very strong scientific expertise in immunology and this is how the MS franchise was born.

I'd like to discuss our two phase III Lupus program next.

First is [inaudible], which we have in collaboration with UCB currently in phase III. We also have [inaudible] 59, our wholly owned anti BDC two monoclonal antibody. Both are potential first in class molecules in SLE. SLE is an autoimmune disease that can affect multiple organs, and can lead to severe organ damage and morbidity, especially amongst the non-Caucasian patients.

We also have little filler map, albeit 59, our wholly owned anti BDC to monoclonal antibody.

Both are potential first in class molecules and SLE.

SLE is an autoimmune disease that can affect multiple organ.

And can lead to severe organ damage and morbidity, especially amongst the non Caucasian patients.

[inaudible] also has the potential to be a first in class treatment for CLE. CLE, cutaneous lupus erythematosus is a skin based auto immune disease and can exist in the absence of systemic manifestations. Chronic CLE is associated with severe skin damage and impaired quality of life. No new treatment approved specifically for CLE in almost 70 years.

Cle cutaneous lupus erythematosus at skin.

Didn't based auto immune disease and can exist in the absence of systemic manifestations.

Chronic cle is associated with severe skin damage and impaired quality of life.

No new treatment approved specifically for Sealy in almost 70 units.

The CLE part of the phase two lilac study met its primary endpoint and the results were published last summer in the New England Journal of Medicine. Based upon these encouraging results, we initiated the phase two three admetus study of [inaudible] in CLE. Lupus disproportionately impacts underrepresented populations and we have set enrollment targets in [inaudible] studies to reflect this high prevalence in African American and Hispanic or Latino communities.

Based upon these encouraging results we initiated the phase two three admetus study of Linda follow map and CME.

Notebooks disproportionately impact underrepresented populations and we have set enrollment targets analytics Allomap studies.

Select this high prevalence in African American and Hispanic or Latino community.

Next I will discuss ALS. ALS is a devastating progressive neuro degenerative disease. [inaudible] ALS is an ultra rare genetic form that affects approximately 330 individuals in the US.

<unk> is a devastating progressive neuro degenerative disease.

<unk> is an ultra rare genetic form that affects approximately 330 individuals in the U S.

While the valor phase III study [inaudible] ALS did not hit the primary endpoint, we have published our 12 month data from both valor and the open label extension in the New England Journal of Medicine last year.

In these results, we observed a sustained reduction in neurofilament which is a marker of [inaudible] injury and neurodegeneration in individuals who initiated [inaudible] earlier. We also observed a slower decline in measures of clinical and respiratory function as well as strength and quality of life. With a [inaudible] action date of April 25, 2023, Biogen has the potential to deliver [inaudible] targeted therapy to people suffering from [inaudible] ALS. And we recently announced the March '22, '23 dates for the Advisory Committee meeting for [inaudible]. EMEA has submitted the marketing authorization application for [inaudible] for review in the European Union. 

It's a steep reduction in Europe.

Which is a marker of external injury.

Degeneration.

Individuals who initiated earlier.

We also observed a slower decline in measures of clinical and respiratory function as well as strength and quality of life.

With a <unk> action date of April 25, 2023.

<unk> has the potential to deliver <unk> targeted therapy.

Suffering from saltwater.

As we recently announced the March 'twenty to 'twenty, two 'twenty three deep for the Advisory Committee meeting. EMEA has. The marketing authorization application, but a question for <unk>. In the European Union. Alright.

EMEA has. The marketing authorization application, but a question for <unk>. In the European Union. Alright.

The marketing authorization application, but a question for <unk>. In the European Union. Alright.

In the European Union. Alright.

Alright.

Moving on at a higher level, as Chris mentioned, our goal is to rebalance the R&D pipeline. In this context, we have developed a framework to guide our decision making. And the focus is on the pre-proof of concept programs. For example, we are investing to win in programs where we have a high degree of biological confidence such as [inaudible] while we continue to apply a systematic data driven approach in this program to learn and [inaudible]. We may also choose to discontinue development with some programs based on their regulatory development of commercialization challenges. Examples of recently discontinued programs, including [inaudible] in Europe and oral [inaudible] in MS.

In this context, we have developed a framework to guide our decision making. And the focus is on the pre proof of concept programs. For example, we are investing to win in programs, where we have a high degree of biological confidence such as <unk>. While we continue to apply a systemic systematic data driven approach in this program to loan and Ddos. We may also choose to discontinue development with some programs based on their regulatory development of commercialization challenges. Examples of recently discontinued programs, including <unk> in Europe. And oral abroad. Sure.

And the focus is on the pre proof of concept programs.

For example, we are investing to win in programs, where we have a high degree of biological confidence such as <unk>.

While we continue to apply a systemic systematic data driven approach in this program to loan and Ddos.

We may also choose to discontinue development with some programs based on their regulatory development of commercialization challenges.

Examples of recently discontinued programs, including <unk> in Europe. And oral abroad. Sure.

And oral abroad.

Sure.

In parallel, we have several focus areas to help increase the productivity of our pipeline and decrease risks. Firstly, to derisk and improve the probability of success in the pre-proof of concept portfolio. Second is to enhance the roll off and capabilities for translational science and importantly, our overall focus on value generation versus achievement of our patient milestones alone.

Foster to Derisk and improved probability of success in the pre proof of concept portfolio second is to enhance the roll off and capabilities for translational science and importantly, our overall focus on value generation versus achievement of a patient. Milestones alone.

Milestones alone.

In conclusion, with keys assets in Alzheimer's disease, depression, and lupus, we believe the Biogen pipeline has potential to deliver significant growth over the medium and long term. I will now pass the call over back to Mike.

MS disease Depression, and lupus, we believe the Biogen pipeline has potential to deliver significant growth over the medium and long term.

I will now pass the call over back to Mike.

Michael R. McDonnell: Thank you Priya. I will now go through our 2023 guidance ranges and talk about some of the key assumptions and then we'll open it up for questions.

We expect a full year 2023 revenue decline 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 and $16.

There are several dynamics that we expect in 2023 that I would like to highlight. First, our guidance assumes a favorable decision by the court of Justice of the European Union relating to regulatory data protection for Tecfidera, and that is currently expected to be on March 16th as I mentioned earlier of this year, although we obviously cannot predict the outcome of that.

There are several dynamics that we expect in 2023 that I would like to highlight first our guidance assumes a favorable decision by the court of Justice of the European Union relating to regulatory data protection to protect Vadera.

And that is currently expected to be on March 16th as I mentioned earlier of this year, although we obviously cannot predict the outcome of that.

This guidance also assumes modest end market revenue for [inaudible] in 2023 with commercialization expenses exceeding revenue. And Biogen will record its share of net commercial profits and losses for [inaudible] in the US as a component of total revenue and we do expect this to be a headwind to our revenue in 2023.

And Biogen will record its share of net commercial profits and losses for [inaudible] in the US as a component of total revenue and we do expect this to be a headwind to our revenue in 2023.

Just as a reminder, in 2022, we amended our collaboration agreement with Eisai for [inaudible], and as a result, we will have sole decision making and commercialization rights along with a substantial majority of the economics beginning in 2023.

Eisai will receive a tiered royalty and will no longer share in expenses related to [inaudible], and this does result in two important considerations for 2023.

First we expect to incur approximately $150 million to $200 million of excess capacity charges in 2023. And all of that will be borne by Biogen. In 2022, we incurred $119 million of idle capacity, and of that amount, $55 million was reimbursed by Eisai.

And all of that will be borne by Biogen in 2022, we incurred $119 million of idle capacity.

And of that amount $55 million was reimbursed by eisai.

Our cost of sales as a percentage of revenue is expected to be higher in 2023 than the 22.4% that we saw in 2022. And that's as a result of product mix as well as the dynamic that I just described. We expect this pressure on cost of goods sold to be particularly pronounced earlier in the year.

And Thats as a result of product mix as well as the dynamic that I just described.

We expect this pressure on cost of goods sold to be particularly pronounced earlier in the year.

Okay.

The second result of the amended agreement with Eisai is that we will no longer be sharing [inaudible] helm R&D costs and this is expected to create an increase of approximately $100 million in R&D expense in 2023 as compared to 2022. Full year operating expenses, which are comprised of both SG&A and R&D expense will reflect our previously disclosed $1 billion of cost reduction measures and we expect that approximately $300 million of these cost savings will be reinvested to support the launch of [inaudible] and other new products. So we expect that this will result in $700 million of net operating expense savings relative to full year 2021 operating expenses, which were approximately $5.2 billion.

Approximately $100 million in R&D expense in 2023 as compared to 2022.

Full year operating expenses, which are comprised of both SG&A and R&D expense will reflect our previously disclosed $1 billion of cost reduction measures.

and we expect that approximately $300 million of these cost savings will be reinvested to support the launch of [inaudible] and other new products. So we expect that this will result in $700 million of net operating expense savings relative to full year 2021 operating expenses, which were approximately $5.2 billion.

So we expect that this will result in $700 million of net operating expense savings relative to full year 2021, operating expenses, which were approximately $5 2 billion.

We are continuing to monitor potential supply constraints for IMRALDI and our guidance does not assume any stock outs, but this does remain a risk. There are also some key seasonality dynamics that we'd like to note. As a reminder, Q1 tends to be a seasonally weaker quarter as compared to Q4 for our MS business in the US and that's due to channel dynamics, and the higher discounts and allowances. SPINRAZA benefited in Q4 of 2022 in part due to the timing of some shipments. And additionally, as a reminder, the royalty rate for [inaudible] resets at the beginning of each year and this rate increases as sales levels increase throughout the year.

There are also some key seasonality dynamics that wed like to note as a reminder, Q1 tends to be seasonally weaker.

A weaker quarter as compared to Q4 for our EMS business in the U S and Thats due to channel dynamics.

And the higher discounts and allowances spin.

It's been Rozzer benefited in Q4 of 2022 in part due to the timing of some shipments.

And additionally, as a reminder, the royalty rate for [inaudible] resets at the beginning of each year and this rate increases as sales levels increase throughout the year.

Increases of sales levels increase throughout the year.

We also expect that our operating expenses will be higher earlier in the year given that some of our cost savings initiatives will take time to materialize over the course of 2023. And of course, as always, we assume that foreign exchange rates as of December 31, 2022 will remain in effect for the year net of our hedging activities and I would refer you to our press release for other important guidance assumptions.

2023.

And of course as always we assume that foreign exchange rates as of December 31, 2022 will remain in effect for the year net of our hedging activities and I would refer you to our press release for other important guidance assumptions.

Before concluding, I want to highlight a few of the key accounting considerations for [inaudible]. And now that [inaudible] has received accelerated approval in the United States, Biogen's 50% share of net commercial profits and losses, which includes in market revenue, less cost of goods, royalties, and SG&A will be reflected as a component of total revenue. As I mentioned, we expect this to be negative in 2023 as we expect the commercial expenses will exceed revenue.

And now that we can be as received accelerated approval in the United States Biogen's, 50% share of net commercial profits and losses.

Which includes in market revenue less cost of goods royalties and SG&A will be reflected as a component of total revenue as I mentioned, we expect this to be negative in 2023, as we expect the commercial expenses will exceed revenue.

Outside the US, our 50% share of commercial expenses will continue to be recorded within SG&A expense until it can be approved on a region by region basis. Separately, Biogen's 50% share of global [inaudible] R&D expenditures will continue to be reflected within R&D expense and this is both before and after approval.

Separately biogen's, 50% share of global what can be R&D expenditures will continue to be reflected within R&D expense and this is both before and after approval.

And finally on [inaudible], Biogen is manufacturing [inaudible] drug substance and our solid turn Switzerland facility, we capitalized inventory until it is sold to Eisai at which point, we will recognize contract manufacturing revenue and contract manufacturing cost of goods sold and that will be at a minimal gross margin. 

Margin.

Yeah.

[inaudible] is also a 50-50 profit share in the US with our partner Sage Therapeutics. Prior to regulatory approval, we will record our share of R&D and SG&A expense in their respective line items net of reimbursement to or from Sage. After US approval, Biogen will record 100% of [inaudible] product revenue cost of goods and SG&A and then we will share Sage's 50% of profits or losses as a component of Biogen's collaboration profit sharing line.

In their respective line items net of reimbursement to or from Sage.

After U S approval Biogen will record 100% of is around alone product revenue cost of goods and SG&A and then we will share stages, 50% of profits or losses is a component of biogen's collaboration profit sharing line.

So in closing, our number one goal is to return Biogen to sustainable growth. We believe that the potential launches of [inaudible] along with the rest of our pipeline and our strong balance sheet provide us with the necessary elements to achieve this goal and we are also working very hard to improve our operating efficiency and remain committed to creating long term value for our shareholders. And with that, we'll open up the call for questions.

We believe that the potential launches of where can be ins around alone along with the rest of our pipeline and our strong balance sheet provide us with the necessary elements to achieve this goal and we are also working very hard to improve our operating efficiency and remain committed to creating long term value.

For our shareholders and with that we'll open up the call for questions.

Operator: Thank you. If you would like to ask a question, please press star one on your telephone keypad.

As a reminder, please limit yourself to one question. If you require any further follow up, you may press star one again to rejoin the queue.

If you require any further follow up you May press star one again to rejoin the queue.

Operator: Your first question comes from the line of Salveen Richter of Goldman Sachs. Please go ahead.

Salveen Jaswal Richter: Good morning, thank you for taking my question here. Maybe a question of whether you can lay out potential timelines for the NCD reconsideration from the [inaudible]. Historical precedent suggests it could take about nine months but when [inaudible] this process could start [inaudible] approval and when will we know when the process has been initiated? Thank you.

A question of whether you can lay out potential timelines for the NCD reconsideration from the camby.

Oracle precedent.

Could take about nine months.

This process.

Could it start.

The approval and then when will we know when the <unk>.

This has been initiated thank you.

Christopher A. Viehbacher: Thanks for the question. Look, I'm not so sure first of all that precedent is going to really matter here. I think this is an unusual set of circumstances. So there are negotiations and discussions ongoing between Eisai and CMS today. CMS could decide whatever. The feeling is that they're going to wait until there is a traditional approval and then we will see. Will there be a registry? Won't there be a registry? We just don't know at this stage. What I would say is that I think you're seeing a much different tone in the broader community than we had with [inaudible]. You've seen the American Association of Neurologists to CMS to support reimbursement. You've seen members of Congress, they can tell you that the neurology community broadly look at the clarity data as being very compelling in terms of the impact. Obviously, CMS makes its own decisions but I think there is a growing consensus that this is a medicine that is very much needed by a broad population base and Eisai has guided to their hope that there would be this broader reimbursement once they have traditional approval.

I'm not so sure first of all that precedent, that's going to really matter here.

I think this is an unusual set of circumstances.

And so.

There are negotiations and discussions ongoing between <unk> and CMS today.

No.

Thats could decide whatever.

The feeling is that theyre going to wait until there is a traditional approval and then we will see will there be a registry won't there be a registry. We just don't know at this stage what I would say is. But I think youre seeing a much different tone. In the broader community than we had with <unk>. You've seen the American Association of Neurologists. To CMS to support reimbursement. You've seen members of Congress. Can tell you that the neurology community look at broadly look at the clarity data as being very compelling in terms of the of the impact obviously CMS makes its own decisions but. I think there is a growing consensus that this is a medicine that is very much needed. A broad population based <unk> has guided to their hope that there would be this broader reimbursement once they have traditional approval.

But I think youre seeing a much different tone. In the broader community than we had with <unk>. You've seen the American Association of Neurologists. To CMS to support reimbursement. You've seen members of Congress. Can tell you that the neurology community look at broadly look at the clarity data as being very compelling in terms of the of the impact obviously CMS makes its own decisions but. I think there is a growing consensus that this is a medicine that is very much needed. A broad population based <unk> has guided to their hope that there would be this broader reimbursement once they have traditional approval.

In the broader community than we had with <unk>. You've seen the American Association of Neurologists. To CMS to support reimbursement. You've seen members of Congress. Can tell you that the neurology community look at broadly look at the clarity data as being very compelling in terms of the of the impact obviously CMS makes its own decisions but. I think there is a growing consensus that this is a medicine that is very much needed. A broad population based <unk> has guided to their hope that there would be this broader reimbursement once they have traditional approval.

You've seen the American Association of Neurologists. To CMS to support reimbursement. You've seen members of Congress. Can tell you that the neurology community look at broadly look at the clarity data as being very compelling in terms of the of the impact obviously CMS makes its own decisions but. I think there is a growing consensus that this is a medicine that is very much needed. A broad population based <unk> has guided to their hope that there would be this broader reimbursement once they have traditional approval.

To CMS to support reimbursement. You've seen members of Congress. Can tell you that the neurology community look at broadly look at the clarity data as being very compelling in terms of the of the impact obviously CMS makes its own decisions but. I think there is a growing consensus that this is a medicine that is very much needed. A broad population based <unk> has guided to their hope that there would be this broader reimbursement once they have traditional approval.

You've seen members of Congress. Can tell you that the neurology community look at broadly look at the clarity data as being very compelling in terms of the of the impact obviously CMS makes its own decisions but. I think there is a growing consensus that this is a medicine that is very much needed. A broad population based <unk> has guided to their hope that there would be this broader reimbursement once they have traditional approval.

Can tell you that the neurology community look at broadly look at the clarity data as being very compelling in terms of the of the impact obviously CMS makes its own decisions but. I think there is a growing consensus that this is a medicine that is very much needed. A broad population based <unk> has guided to their hope that there would be this broader reimbursement once they have traditional approval.

I think there is a growing consensus that this is a medicine that is very much needed. A broad population based <unk> has guided to their hope that there would be this broader reimbursement once they have traditional approval.

A broad population based <unk> has guided to their hope that there would be this broader reimbursement once they have traditional approval.

Operator: Our next question comes from the line of Mohit Bansal of Wells Fargo.

Come from the line of Mohit Bansal of Wells Fargo.

Mohit Bansal: Great. Thank you for taking my question. Maybe a question on expense cuts. I know earlier this year, you talked about expense cuts and I mean, if you do the math, it's very clear that for the FERC portfolio at the expense base is very high. I mean have you thought about your target operating margin profile long term and how much more cuts can you do and any timelines when we could hear about this because you also talked about almost $200 million of [inaudible] expense here. You said that you would probably prioritize and figure out whether you want to keep spending that money or not, so can we talk a little bit about the timelines of that now that you are in the business review more? Thank you.

Maybe a question on expense cuts.

I know earlier this year, you talked about expenses and I mean, if you do the math.

The key for the FERC portfolio at the expense base is very high.

Can you talk about I mean have you talked about your target operating margin profile long term and.

How much more cuts how much more cuts can you do.

Any timelines when we could hear about this because you also talked about.

Almost $200 million of Canyon.

Okay.

Here, you said that you would probably prioritize and figure out whether you want to keep spending that money or not so can we talk a little bit about the timelines of that now that you are in the business review more thank you.

Christopher A. Viehbacher: In Opex, you've got two big buckets, right? You've got R&D and you've got SG&A. In R&D, we are looking at this whole prioritization exercise. And that means if you want to save money to a degree you may have to cut some programs. And that's not something that you want to do quickly. You need to go and look at each program thoroughly, determined probabilities of success, cost to complete, a whole bunch of other things. There is an infrastructure element to R&D that we will be looking at as a matter of priority.

And Opex, you've got two big buckets, you've got R&D and you've got SG&A.

In R&D.

We are looking at this whole prioritization exercise.

And that means if you want to save money to a degree you have to you may have to cut some programs.

And that's not something that you want to do quickly you need to go and look at each program thoroughly.

Determined probabilities of success cost to complete a whole bunch of other things there is an infrastructure element to R&D that we will be looking at.

And then you have SG&A, and within the sales and marketing, obviously, most of that spend is really going to the MS franchise. The MS franchise still supports most of our revenue in the business and so one has to be careful about how much we want to reduce that spend by but clearly that's a declining revenue base and so I think what you're really going to see is a shift from some of those resources to supporting the launch. Now, there's  hundreds of millions of dollars growing between Eisai, Sage and Biogen behind the prelaunch activities this year for [inaudible], and those are obviously strategic products for all of the companies and we really need to support the launches, but we have to find the right balance and not seeing a decline in MS sales beyond what we already see. And then there is G&A and we will be taking a close look at that this year, so you're going to see some reductions in costs, but there is obviously going to be some new investments.

No. MS franchise still supports. Most of our revenue in the business and so it won't have to be careful about how much we do. We wanted to reduce that spend by but clearly that's a declining revenue base and so I think what you're really going to see is a shift from some of those resources to supporting the launch with hundreds of millions of dollars growing between eight psi sage and Biogen behind the prelaunch. This year for. It can be an zarin alone and those obviously strategic products for all of the companies and we really need to support the launches. But we have to be find the right balance and not. And not seeing a decline in EMS sales beyond what we already see. And then there is G&A and we will be taking a close look at that this year, so you're going to see some reductions in costs, but there is obviously going to be some new investments and so it's a little hard to say at this point.

MS franchise still supports. Most of our revenue in the business and so it won't have to be careful about how much we do. We wanted to reduce that spend by but clearly that's a declining revenue base and so I think what you're really going to see is a shift from some of those resources to supporting the launch with hundreds of millions of dollars growing between eight psi sage and Biogen behind the prelaunch. This year for. It can be an zarin alone and those obviously strategic products for all of the companies and we really need to support the launches. But we have to be find the right balance and not. And not seeing a decline in EMS sales beyond what we already see. And then there is G&A and we will be taking a close look at that this year, so you're going to see some reductions in costs, but there is obviously going to be some new investments and so it's a little hard to say at this point.

Most of our revenue in the business and so it won't have to be careful about how much we do. We wanted to reduce that spend by but clearly that's a declining revenue base and so I think what you're really going to see is a shift from some of those resources to supporting the launch with hundreds of millions of dollars growing between eight psi sage and Biogen behind the prelaunch. This year for. It can be an zarin alone and those obviously strategic products for all of the companies and we really need to support the launches. But we have to be find the right balance and not. And not seeing a decline in EMS sales beyond what we already see. And then there is G&A and we will be taking a close look at that this year, so you're going to see some reductions in costs, but there is obviously going to be some new investments and so it's a little hard to say at this point.

We wanted to reduce that spend by but clearly that's a declining revenue base and so I think what you're really going to see is a shift from some of those resources to supporting the launch with hundreds of millions of dollars growing between eight psi sage and Biogen behind the prelaunch. This year for. It can be an zarin alone and those obviously strategic products for all of the companies and we really need to support the launches. But we have to be find the right balance and not. And not seeing a decline in EMS sales beyond what we already see. And then there is G&A and we will be taking a close look at that this year, so you're going to see some reductions in costs, but there is obviously going to be some new investments and so it's a little hard to say at this point.

This year for. It can be an zarin alone and those obviously strategic products for all of the companies and we really need to support the launches. But we have to be find the right balance and not. And not seeing a decline in EMS sales beyond what we already see. And then there is G&A and we will be taking a close look at that this year, so you're going to see some reductions in costs, but there is obviously going to be some new investments and so it's a little hard to say at this point.

It can be an zarin alone and those obviously strategic products for all of the companies and we really need to support the launches. But we have to be find the right balance and not. And not seeing a decline in EMS sales beyond what we already see. And then there is G&A and we will be taking a close look at that this year, so you're going to see some reductions in costs, but there is obviously going to be some new investments and so it's a little hard to say at this point.

But we have to be find the right balance and not. And not seeing a decline in EMS sales beyond what we already see. And then there is G&A and we will be taking a close look at that this year, so you're going to see some reductions in costs, but there is obviously going to be some new investments and so it's a little hard to say at this point.

And not seeing a decline in EMS sales beyond what we already see. And then there is G&A and we will be taking a close look at that this year, so you're going to see some reductions in costs, but there is obviously going to be some new investments and so it's a little hard to say at this point.

And then there is G&A and we will be taking a close look at that this year, so you're going to see some reductions in costs, but there is obviously going to be some new investments and so it's a little hard to say at this point.

And so it's a little hard at this point to say where we're going to end up on margins, but if you strip out the royalty and collaboration income and do the Opex to sales ratios were clearly higher than most of our peer companies and considering that we have a fairly mature product profile of high value, low volume products, we should be more profitable but the company has already taken a $1 billion, so that means more cost savings have to be done thoughtfully. So we'll be giving you updates throughout the year on that but we are conscious that the cost base needs to be more productive than it is.

If you strip out the royalty and collaboration income and due to the Opex to sales ratios were clearly higher. And then most of our peer companies and considering that we have a fairly mature product profile of high volume of high value low volume products. We should be more profitable but. The company has already taken a $1 billion. So that means more cost savings have to be done thoughtfully. So we'll be giving you updates throughout the year on that but we are conscious that the cost base. Needs to be more productive than it is.

And then most of our peer companies and considering that we have a fairly mature product profile of high volume of high value low volume products. We should be more profitable but. The company has already taken a $1 billion. So that means more cost savings have to be done thoughtfully. So we'll be giving you updates throughout the year on that but we are conscious that the cost base. Needs to be more productive than it is.

We should be more profitable but. The company has already taken a $1 billion. So that means more cost savings have to be done thoughtfully. So we'll be giving you updates throughout the year on that but we are conscious that the cost base. Needs to be more productive than it is.

The company has already taken a $1 billion. So that means more cost savings have to be done thoughtfully. So we'll be giving you updates throughout the year on that but we are conscious that the cost base. Needs to be more productive than it is.

Needs to be more productive than it is.

On [inaudible], we will be looking at the Embarq data which is long term. That will give some information about not just for [inaudible] but also how we think about the longer term treatment of amyloid reducing antibodies. We also need to see exactly what the landscape is. What I can tell you is there is no commercial effort behind [inaudible]. Our focus is on the [inaudible], we believe that is the product that is most appropriate for patients. We do have a commitment to the FDA to do this confirmatory study, so we have to think through that carefully. But I just wanted to be clear that from a strategic point of view, [inaudible] is our absolute priority and [inaudible] is not being actively commercialized anywhere. 

On <unk> home. <unk>, we will see we will be looking at the Embarq data. Which is long term. That will give some information about. Not just for <unk>, but also. How we think about the longer term treatment. <unk> reducing antibodies. We also need to see exactly what the landscape is what I can tell you is there is no. Actual effort behind our focus is on the <unk>. We believe that is the the product that is most appropriate for patients. Do have a commitment to the FDA to do this confirmatory study. So we have to think through that carefully but. Just wanted to be clear that from a strategic point of view Mckenzie as our absolute priority in <unk> is not being actively commercialized anywhere. Yes.

<unk>, we will see we will be looking at the Embarq data. Which is long term. That will give some information about. Not just for <unk>, but also. How we think about the longer term treatment. <unk> reducing antibodies. We also need to see exactly what the landscape is what I can tell you is there is no. Actual effort behind our focus is on the <unk>. We believe that is the the product that is most appropriate for patients. Do have a commitment to the FDA to do this confirmatory study. So we have to think through that carefully but. Just wanted to be clear that from a strategic point of view Mckenzie as our absolute priority in <unk> is not being actively commercialized anywhere. Yes.

Which is long term. That will give some information about. Not just for <unk>, but also. How we think about the longer term treatment. <unk> reducing antibodies. We also need to see exactly what the landscape is what I can tell you is there is no. Actual effort behind our focus is on the <unk>. We believe that is the the product that is most appropriate for patients. Do have a commitment to the FDA to do this confirmatory study. So we have to think through that carefully but. Just wanted to be clear that from a strategic point of view Mckenzie as our absolute priority in <unk> is not being actively commercialized anywhere. Yes.

That will give some information about. Not just for <unk>, but also. How we think about the longer term treatment. <unk> reducing antibodies. We also need to see exactly what the landscape is what I can tell you is there is no. Actual effort behind our focus is on the <unk>. We believe that is the the product that is most appropriate for patients. Do have a commitment to the FDA to do this confirmatory study. So we have to think through that carefully but. Just wanted to be clear that from a strategic point of view Mckenzie as our absolute priority in <unk> is not being actively commercialized anywhere. Yes.

Not just for <unk>, but also. How we think about the longer term treatment. <unk> reducing antibodies. We also need to see exactly what the landscape is what I can tell you is there is no. Actual effort behind our focus is on the <unk>. We believe that is the the product that is most appropriate for patients. Do have a commitment to the FDA to do this confirmatory study. So we have to think through that carefully but. Just wanted to be clear that from a strategic point of view Mckenzie as our absolute priority in <unk> is not being actively commercialized anywhere. Yes.

How we think about the longer term treatment. <unk> reducing antibodies. We also need to see exactly what the landscape is what I can tell you is there is no. Actual effort behind our focus is on the <unk>. We believe that is the the product that is most appropriate for patients. Do have a commitment to the FDA to do this confirmatory study. So we have to think through that carefully but. Just wanted to be clear that from a strategic point of view Mckenzie as our absolute priority in <unk> is not being actively commercialized anywhere. Yes.

<unk> reducing antibodies. We also need to see exactly what the landscape is what I can tell you is there is no. Actual effort behind our focus is on the <unk>. We believe that is the the product that is most appropriate for patients. Do have a commitment to the FDA to do this confirmatory study. So we have to think through that carefully but. Just wanted to be clear that from a strategic point of view Mckenzie as our absolute priority in <unk> is not being actively commercialized anywhere. Yes.

We also need to see exactly what the landscape is what I can tell you is there is no. Actual effort behind our focus is on the <unk>. We believe that is the the product that is most appropriate for patients. Do have a commitment to the FDA to do this confirmatory study. So we have to think through that carefully but. Just wanted to be clear that from a strategic point of view Mckenzie as our absolute priority in <unk> is not being actively commercialized anywhere. Yes.

Actual effort behind our focus is on the <unk>. We believe that is the the product that is most appropriate for patients. Do have a commitment to the FDA to do this confirmatory study. So we have to think through that carefully but. Just wanted to be clear that from a strategic point of view Mckenzie as our absolute priority in <unk> is not being actively commercialized anywhere. Yes.

Do have a commitment to the FDA to do this confirmatory study. So we have to think through that carefully but. Just wanted to be clear that from a strategic point of view Mckenzie as our absolute priority in <unk> is not being actively commercialized anywhere. Yes.

Just wanted to be clear that from a strategic point of view Mckenzie as our absolute priority in <unk> is not being actively commercialized anywhere. Yes.

Yes.

Operator: Our next question comes from Colin Bristow of UBS. Please go ahead.

Colin Nigel Bristow: Hey, good morning, and thanks for taking the question. Chris, in terms of your ongoing review of the business and the pipeline, how should we be thinking about timelines just in terms of the potential for strategic activities with [inaudible], and then just more broadly in terms of business development, when you've clearly identified the targets and potentially willing to move forward. And then just within this question, could you just characterize your ongoing interest in Biosimilar? Thank you.

Chris.

In terms of your ongoing business.

And the pipeline how should we be thinking about it.

Just in terms of the potential for strategic activities with Abbvie.

And then just more broadly in terms of business development.

Clearly identify the targets.

Okay and then just within this question could you just characterize your ongoing.

Thank you.

Christopher A. Viehbacher: So on R&D, you have a number of projects that have been ongoing for a number of years. We have a number of products actually in phase III that are actually proof of concept studies. There are at least not even including [inaudible], we have three products in development where we did not have safety or efficacy data out of a positive phase II. So I think we need to think carefully about each of those programs. It does take some time. And there is always a question about how much do we have to spend to the next milestone and is that really worth it, can we think about different ways of doing this study, can we de risk these? So that will probably take us through to the summer before I think we can really make too many decisions on that front. Biosimilars, it's an extremely strong team and they've built a successful business. But I look at Biogen as a company with innovative medicines. We're not a huge company by any means and there needs to be a focus. So we are looking at what's the right business model for it. It is a successful business, it's an important business for society, but we need to think about where we put our resources. When you look at the cost base, it's not just a question I found in the company about how much we spend but how we spend it. And there have been a number of projects around and other areas where we're spending money. And I think one of the things I'm really trying to drive is focus in the company, what really matters, what's going to grow the business, and how do we align our resources behind that. And whatever it is not one of the major growth drivers and I think we have to look carefully at whether we continue to to either to support that business with resources or we think about other options for some of those businesses.

Christopher A. Viehbacher: So on R&D, you have a number of projects that have been ongoing for a number of years. We have a number of products actually in phase III that are actually proof of concept studies. There are at least not even including [inaudible], we have three products in development where we did not have safety or efficacy data out of a positive phase II. So I think we need to think carefully about each of those programs. It does take some time. And there is always a question about how much do we have to spend to the next milestone and is that really worth it, can we think about different ways of doing this study, can we de risk these? So that will probably take us through to the summer before I think we can really make too many decisions on that front.

And you have.

You have a number of projects that have been ongoing for a number of years.

We have a number of products actually in phase III that are actually proof of concept studies.

There are at least not not even clothing <unk> home, we have three products in development.

We did not have safety or efficacy data out of a positive phase III. So I think we need to think carefully about each of those programs. It does take some time.

And there is always a question about how much do we have to spend to the next milestone and is that really worth. It can we think about different ways of doing this study can we de risk. These. So that will probably take us. Through to the summer before I think we can really make too many. Decisions on that front. Biosimilars. It's an extremely strong team and they built a successful business. But. I look at Biogen is a company with innovative medicines. We're not a huge company by me and by any means and there needs to be a focus. So we are looking at what's the right business model for it it is a it as I say a successful business, it's an important business for society. But we need to think about where we put our resources. When you look at the cost base, it's not just a question I found in the company, but how much we spend but how we spend it and there have been a number of projects around and other areas, where we're spending money. And I think one of the things I'm really trying to drive is focus in the company, what really matters, what's going to grow the business and how do we align our resources behind that and whatever it is not one of the major growth drivers and I think we have to look carefully at and whether we continue to to either to support that business with resources. We think about other options for some of those businesses.

So that will probably take us. Through to the summer before I think we can really make too many. Decisions on that front. Biosimilars. It's an extremely strong team and they built a successful business. But. I look at Biogen is a company with innovative medicines. We're not a huge company by me and by any means and there needs to be a focus. So we are looking at what's the right business model for it it is a it as I say a successful business, it's an important business for society. But we need to think about where we put our resources. When you look at the cost base, it's not just a question I found in the company, but how much we spend but how we spend it and there have been a number of projects around and other areas, where we're spending money. And I think one of the things I'm really trying to drive is focus in the company, what really matters, what's going to grow the business and how do we align our resources behind that and whatever it is not one of the major growth drivers and I think we have to look carefully at and whether we continue to to either to support that business with resources. We think about other options for some of those businesses.

Through to the summer before I think we can really make too many. Decisions on that front. Biosimilars. It's an extremely strong team and they built a successful business. But. I look at Biogen is a company with innovative medicines. We're not a huge company by me and by any means and there needs to be a focus. So we are looking at what's the right business model for it it is a it as I say a successful business, it's an important business for society. But we need to think about where we put our resources. When you look at the cost base, it's not just a question I found in the company, but how much we spend but how we spend it and there have been a number of projects around and other areas, where we're spending money. And I think one of the things I'm really trying to drive is focus in the company, what really matters, what's going to grow the business and how do we align our resources behind that and whatever it is not one of the major growth drivers and I think we have to look carefully at and whether we continue to to either to support that business with resources. We think about other options for some of those businesses.

Christopher A. Viehbacher: Biosimilars, it's an extremely strong team and they've built a successful business. But I look at Biogen as a company with innovative medicines. We're not a huge company by any means and there needs to be a focus. So we are looking at what's the right business model for it. It is a successful business, it's an important business for society, but we need to think about where we put our resources. When you look at the cost base, it's not just a question I found in the company about how much we spend but how we spend it. And there have been a number of projects around and other areas where we're spending money. And I think one of the things I'm really trying to drive is focus in the company, what really matters, what's going to grow the business, and how do we align our resources behind that. And whatever it is not one of the major growth drivers and I think we have to look carefully at whether we continue to to either to support that business with resources or we think about other options for some of those businesses.

Decisions on that front. Biosimilars. It's an extremely strong team and they built a successful business. But. I look at Biogen is a company with innovative medicines. We're not a huge company by me and by any means and there needs to be a focus. So we are looking at what's the right business model for it it is a it as I say a successful business, it's an important business for society. But we need to think about where we put our resources. When you look at the cost base, it's not just a question I found in the company, but how much we spend but how we spend it and there have been a number of projects around and other areas, where we're spending money. And I think one of the things I'm really trying to drive is focus in the company, what really matters, what's going to grow the business and how do we align our resources behind that and whatever it is not one of the major growth drivers and I think we have to look carefully at and whether we continue to to either to support that business with resources. We think about other options for some of those businesses.

Biosimilars. It's an extremely strong team and they built a successful business. But. I look at Biogen is a company with innovative medicines. We're not a huge company by me and by any means and there needs to be a focus. So we are looking at what's the right business model for it it is a it as I say a successful business, it's an important business for society. But we need to think about where we put our resources. When you look at the cost base, it's not just a question I found in the company, but how much we spend but how we spend it and there have been a number of projects around and other areas, where we're spending money. And I think one of the things I'm really trying to drive is focus in the company, what really matters, what's going to grow the business and how do we align our resources behind that and whatever it is not one of the major growth drivers and I think we have to look carefully at and whether we continue to to either to support that business with resources. We think about other options for some of those businesses.

It's an extremely strong team and they built a successful business. But. I look at Biogen is a company with innovative medicines. We're not a huge company by me and by any means and there needs to be a focus. So we are looking at what's the right business model for it it is a it as I say a successful business, it's an important business for society. But we need to think about where we put our resources. When you look at the cost base, it's not just a question I found in the company, but how much we spend but how we spend it and there have been a number of projects around and other areas, where we're spending money. And I think one of the things I'm really trying to drive is focus in the company, what really matters, what's going to grow the business and how do we align our resources behind that and whatever it is not one of the major growth drivers and I think we have to look carefully at and whether we continue to to either to support that business with resources. We think about other options for some of those businesses.

But. I look at Biogen is a company with innovative medicines. We're not a huge company by me and by any means and there needs to be a focus. So we are looking at what's the right business model for it it is a it as I say a successful business, it's an important business for society. But we need to think about where we put our resources. When you look at the cost base, it's not just a question I found in the company, but how much we spend but how we spend it and there have been a number of projects around and other areas, where we're spending money. And I think one of the things I'm really trying to drive is focus in the company, what really matters, what's going to grow the business and how do we align our resources behind that and whatever it is not one of the major growth drivers and I think we have to look carefully at and whether we continue to to either to support that business with resources. We think about other options for some of those businesses.

I look at Biogen is a company with innovative medicines. We're not a huge company by me and by any means and there needs to be a focus. So we are looking at what's the right business model for it it is a it as I say a successful business, it's an important business for society. But we need to think about where we put our resources. When you look at the cost base, it's not just a question I found in the company, but how much we spend but how we spend it and there have been a number of projects around and other areas, where we're spending money. And I think one of the things I'm really trying to drive is focus in the company, what really matters, what's going to grow the business and how do we align our resources behind that and whatever it is not one of the major growth drivers and I think we have to look carefully at and whether we continue to to either to support that business with resources. We think about other options for some of those businesses.

We're not a huge company by me and by any means and there needs to be a focus. So we are looking at what's the right business model for it it is a it as I say a successful business, it's an important business for society. But we need to think about where we put our resources. When you look at the cost base, it's not just a question I found in the company, but how much we spend but how we spend it and there have been a number of projects around and other areas, where we're spending money. And I think one of the things I'm really trying to drive is focus in the company, what really matters, what's going to grow the business and how do we align our resources behind that and whatever it is not one of the major growth drivers and I think we have to look carefully at and whether we continue to to either to support that business with resources. We think about other options for some of those businesses.

So we are looking at what's the right business model for it it is a it as I say a successful business, it's an important business for society. But we need to think about where we put our resources. When you look at the cost base, it's not just a question I found in the company, but how much we spend but how we spend it and there have been a number of projects around and other areas, where we're spending money. And I think one of the things I'm really trying to drive is focus in the company, what really matters, what's going to grow the business and how do we align our resources behind that and whatever it is not one of the major growth drivers and I think we have to look carefully at and whether we continue to to either to support that business with resources. We think about other options for some of those businesses.

But we need to think about where we put our resources. When you look at the cost base, it's not just a question I found in the company, but how much we spend but how we spend it and there have been a number of projects around and other areas, where we're spending money. And I think one of the things I'm really trying to drive is focus in the company, what really matters, what's going to grow the business and how do we align our resources behind that and whatever it is not one of the major growth drivers and I think we have to look carefully at and whether we continue to to either to support that business with resources. We think about other options for some of those businesses.

When you look at the cost base, it's not just a question I found in the company, but how much we spend but how we spend it and there have been a number of projects around and other areas, where we're spending money. And I think one of the things I'm really trying to drive is focus in the company, what really matters, what's going to grow the business and how do we align our resources behind that and whatever it is not one of the major growth drivers and I think we have to look carefully at and whether we continue to to either to support that business with resources. We think about other options for some of those businesses.

And I think one of the things I'm really trying to drive is focus in the company, what really matters, what's going to grow the business and how do we align our resources behind that and whatever it is not one of the major growth drivers and I think we have to look carefully at and whether we continue to to either to support that business with resources. We think about other options for some of those businesses.

We think about other options for some of those businesses.

Operator: Our next question comes from the line of [inaudible] with Evercore.

Unknown: Hi, guys, thanks for taking my question. I wanted to touch up on the infusion capacity a little bit in a little more detail. I feel like we've talked about it several times that infrastructure needs to be built out but could we quantify for example of the 100K patients number I mentioned in some of the prior press releases per year three, how much of that exists today? And could you take an interim look in your ongoing early [inaudible] study where you have a monthly arm to perhaps update the label towards monthly, could that happen anytime soon?

Hi, guys. Thanks for taking my question I wanted to touch up on the infusion capacity a little bit in a little more detail I feel like we've talked about it several times that infrastructure needs to be built out but could we quantify for example of the 100 K patients number I mentioned in some of the prior press releases per year three.

Much of that exists today.

And.

And could you take an interim look in your ongoing early a study where you have a monthly arm to perhaps.

Perhaps update the label towards monthly could that happen anytime soon.

Christopher A. Viehbacher: So on the capacity, obviously Biogen had made quite a bit of progress on that for the launch of [inaudible]. And so I would say, we're probably in better shape today than we were at the launch of [inaudible]. Nonetheless, it's not like there are a lot of empty infusion centers waiting for Alzheimer's patients today, so there is going to have to be continued investment and it will take time and I think one of the reasons that we've guided to 100,000 patients is that there are going to be constraints to the system. There's not a lot of point in talking about what's the potential, how many Alzheimer's patients out there, and how many are eligible, there are natural constraints to this. There is also gonna have to be a careful selection of patients as to who is really the best pace patient to benefit from this treatment and physicians will take their time to understand this new therapy and get experience with the drug. So it's going to be slow steady progress. I can't give you--I wouldn't want to comment today on how many sites, but it is something that is obviously a major part of this launch, that's why I say, it's not really a round white tablet [inaudible].

And.

So I would say, we're probably in better shape today than we were at the launch of add new helm Nonetheless.

It's not like there are a lot of empty infusion centers waiting for Alzheimer's patients. Today. So there is going to have to be continued investment and it will take time and I think one of the reasons that we've guided to 100000 patients is that.

It's just going to they're going to be constraints to the system. There's not a lot of point in talking about what's the potential how many Alzheimer's. Patients out there and how many are eligible. There are natural constraints to theirs. There is also good. You have to be a careful selection of patients as to who is really the best pace. Patient to benefit from this treatment and physicians will take their time to understand this. The new therapy and get experience with the drug.

Patients out there and how many are eligible. There are natural constraints to theirs. There is also good.

There are natural constraints to theirs. There is also good.

There is also good.

You have to be a careful selection of patients as to who is really the best pace.

Patient to benefit from this treatment and physicians will take their time to understand this.

The new therapy and get experience with the drug.

It's going to be slow steady progress I can't give you. And I wouldn't want to comment today on how many sites, but it is something that is. Is obviously a major part of this launch that's why I say, it's not really a round white tablet. As of March.

And I wouldn't want to comment today on how many sites, but it is something that is. Is obviously a major part of this launch that's why I say, it's not really a round white tablet. As of March.

Is obviously a major part of this launch that's why I say, it's not really a round white tablet. As of March.

As of March.

I think the other question was around potentially less frequent maintenance dosing, the timeline for that. Priya, do you want to comment? Sure. So yes exactly right Chris. I think we also think that some of this infusion capacity could be lasting and we'll have a new learning, so I think as you said we'll learn as we go. Two points here. One is that Eisai is already leading on developing a maintenance therapy and this could be either a four week or 12 week dosing paradigm. They have said publicly that they will file for this by Q1 2024, that's important. The other aspect I think that is also in development is a subcutaneous formulation. And I think Eisai and Biogen are thinking about what product like [inaudible] can we have and how do we solve that for patients as well as providers and that is really the strategy behind the subcutaneous development. It is being studied currently in a phase III substudy and it will also be filed by Q1 2024 as Eisai has communicated. So I think we're trying to work from multiple perspectives here and we'll share more updates as they become relevant. 

I think the other question was around potentially less frequent maintenance dosing, the timeline for that. Priya, do you want to comment?

Priya Singhal: Sure. So yes exactly right Chris. I think we also think that some of this infusion capacity could be lasting and we'll have a new learning, so I think as you said we'll learn as we go. Two points here. One is that Eisai is already leading on developing a maintenance therapy and this could be either a four week or 12 week dosing paradigm. They have said publicly that they will file for this by Q1 2024, that's important. The other aspect I think that is also in development is a subcutaneous formulation. And I think Eisai and Biogen are thinking about what product like [inaudible] can we have and how do we solve that for patients as well as providers and that is really the strategy behind the subcutaneous development. It is being studied currently in a phase III substudy and it will also be filed by Q1 2024 as Eisai has communicated. So I think we're trying to work from multiple perspectives here and we'll share more updates as they become relevant.

Two points here one is that.

<unk> is already leading on developing a maintenance therapy and this could be either a four week or 12 week dosing paradigm. They have said publicly that they will file for this by Q1 2024, that's important the other aspect I think that is also in <unk>.

Allotment is a subcutaneous formulation.

We are <unk> and Biogen are thinking about what Burton.

A product like <unk> can be have and how do we solve that for patients as well as providers and that is really the strategy behind the subcutaneous development. It is being studied currently in a phase III study and it will also be filed by Q1 2024 as <unk> communicated so I think.

We're trying to work from multiple perspectives here and we'll share more updates.

They become relevant.

Okay.

Operator: Our next question comes from Evan Seigerman of BMO. Please go ahead.

Evan David Seigerman: Hi, guys. Thanks for taking the question. So Chris, in your remarks, you highlighted a shift in business development, whereas in the past, Biogen may have been more hesitant to acquire. Where would you like to focus BD and what size deals would you be comfortable with? Thank you.

Christopher A. Viehbacher: From a management point of view, you have to think about what's your team good at. What's interesting about Biogen is it's a very narrowly focused company that's been very good at what has been done in multiple sclerosis for example. But you have to think carefully about how broadly you go because we are extremely good at selling high value, low volume products. And even as we contemplate the [inaudible] launch, we are going to be going to a much broader population, we are probably going to have a lot more patient outreach. I think Biogen has done exactly one television commercial in its history, and that's something we're going to have to get good at. So as you think about business development, you have to think about, okay, you can potentially look at things on paper, but can you execute well on them.

A management point of view you have to think about. What's your team good at it.

What's your team good at it.

<unk>.

What's interesting about Biogen as it's been. Very narrowly focused company that's been very good. What has been done in multiple sclerosis for example. But you have to think carefully about how broadly you go because. We are extremely good at selling. High value low volume products, and even as we contemplate the <unk> alone launch. We are going to be going to a much broader population, we are probably going to have a lot more patient outreach.

Very narrowly focused company that's been very good. What has been done in multiple sclerosis for example. But you have to think carefully about how broadly you go because. We are extremely good at selling. High value low volume products, and even as we contemplate the <unk> alone launch. We are going to be going to a much broader population, we are probably going to have a lot more patient outreach.

What has been done in multiple sclerosis for example. But you have to think carefully about how broadly you go because. We are extremely good at selling. High value low volume products, and even as we contemplate the <unk> alone launch. We are going to be going to a much broader population, we are probably going to have a lot more patient outreach.

But you have to think carefully about how broadly you go because. We are extremely good at selling. High value low volume products, and even as we contemplate the <unk> alone launch. We are going to be going to a much broader population, we are probably going to have a lot more patient outreach.

We are extremely good at selling. High value low volume products, and even as we contemplate the <unk> alone launch. We are going to be going to a much broader population, we are probably going to have a lot more patient outreach.

High value low volume products, and even as we contemplate the <unk> alone launch. We are going to be going to a much broader population, we are probably going to have a lot more patient outreach.

We are going to be going to a much broader population, we are probably going to have a lot more patient outreach.

I think Biogen has done exactly one television commercial in its history, and that's something we're going to have to get good at. So as you think about business development, you have to think about, okay, you can potentially look at things on paper, but can you execute well on them. Now, when I look at it, I would say I'd like to be a little bit broader than the traditional neuro degenerative diseases because I don't want to abandon them by any means but if you're only businesses [inaudible], you are really destined to do these long term studies that are highly costly and often the phase III becomes the proof of concept because you can't really test these things adequately in phase II.

I think Biogen has done exactly one television commercial in its history, and that's something we're going to have to get good at. So as you think about business development, you have to think about, okay, you can potentially look at things on paper, but can you execute well on them.

And. That's something we're going to have to get good at so as you think about business development you have to think about okay.

That's something we're going to have to get good at so as you think about business development you have to think about okay.

You can potentially look at things on paper, but can you execute well on them now.

Now, when I look at it, I would say I'd like to be a little bit broader than the traditional neuro degenerative diseases because I don't want to abandon them by any means but if you're only businesses [inaudible], you are really destined to do these long term studies that are highly costly and often the phase III becomes the proof of concept because you can't really test these things adequately in phase II.

When I look at it I would say I'd like to be a little bit broader than the traditional neuro degenerative diseases because.

I don't want to abandon them by any means but.

If youre only businesses that you are you are really destined to do these long term studies that are highly costly and often the phase III becomes the proof of concept.

And so if I sort of say well, where could we legitimately go, where do we have some experience, we can certainly be in immunology because I would argue that things like lupus where we already are even multiple sclerosis is really an autoimmune disease, so I can see us branching out more into immunology. Psychiatry, we'll have one product in the bag with [inaudible]. Would it make sense to expand more into psychiatry. And obviously with SPINRAZA, when we look at how do we get more out of SPINRAZA, when you are in the rare disease business, it's different than most other businesses. Most other therapeutic areas you go see a physician because the patients go to the physician. In rare diseases, you have to go find the patient. I remember at Genzyme someone in marketing teaching me very early on that marketing strategy is looking for needles in haystacks. And that actually becomes a core competency and that's one of the areas that we have to go after.

And so if I sort of say where could we legitimately go where do we have some experience. We can certainly be in immunology. I would argue that things like lupus, where we already are even multiple sclerosis is really an autoimmune disease. So I can see is branching out more into immunology. Psychiatry will have one product in the bag. <unk> alone would it make sense to expand more into psychiatry. And obviously with what's been Raza, when we look at how to how do we get more out of spin Raza. When you are in the rare disease business. It's different than most other businesses most other therapeutic areas you go see a physician because the patients go to the physician and. In rare diseases, you have to go find the patient. <unk>. I remember at Genzyme someone in marketing teaching me very early on that marketing strategy is looking for needles in haystacks.

We can certainly be in immunology. I would argue that things like lupus, where we already are even multiple sclerosis is really an autoimmune disease. So I can see is branching out more into immunology. Psychiatry will have one product in the bag. <unk> alone would it make sense to expand more into psychiatry. And obviously with what's been Raza, when we look at how to how do we get more out of spin Raza. When you are in the rare disease business. It's different than most other businesses most other therapeutic areas you go see a physician because the patients go to the physician and. In rare diseases, you have to go find the patient. <unk>. I remember at Genzyme someone in marketing teaching me very early on that marketing strategy is looking for needles in haystacks.

I would argue that things like lupus, where we already are even multiple sclerosis is really an autoimmune disease. So I can see is branching out more into immunology. Psychiatry will have one product in the bag. <unk> alone would it make sense to expand more into psychiatry. And obviously with what's been Raza, when we look at how to how do we get more out of spin Raza. When you are in the rare disease business. It's different than most other businesses most other therapeutic areas you go see a physician because the patients go to the physician and. In rare diseases, you have to go find the patient. <unk>. I remember at Genzyme someone in marketing teaching me very early on that marketing strategy is looking for needles in haystacks.

Psychiatry will have one product in the bag. <unk> alone would it make sense to expand more into psychiatry. And obviously with what's been Raza, when we look at how to how do we get more out of spin Raza. When you are in the rare disease business. It's different than most other businesses most other therapeutic areas you go see a physician because the patients go to the physician and. In rare diseases, you have to go find the patient. <unk>. I remember at Genzyme someone in marketing teaching me very early on that marketing strategy is looking for needles in haystacks.

<unk> alone would it make sense to expand more into psychiatry. And obviously with what's been Raza, when we look at how to how do we get more out of spin Raza. When you are in the rare disease business. It's different than most other businesses most other therapeutic areas you go see a physician because the patients go to the physician and. In rare diseases, you have to go find the patient. <unk>. I remember at Genzyme someone in marketing teaching me very early on that marketing strategy is looking for needles in haystacks.

And obviously with what's been Raza, when we look at how to how do we get more out of spin Raza. When you are in the rare disease business. It's different than most other businesses most other therapeutic areas you go see a physician because the patients go to the physician and. In rare diseases, you have to go find the patient. <unk>. I remember at Genzyme someone in marketing teaching me very early on that marketing strategy is looking for needles in haystacks.

When you are in the rare disease business. It's different than most other businesses most other therapeutic areas you go see a physician because the patients go to the physician and. In rare diseases, you have to go find the patient. <unk>. I remember at Genzyme someone in marketing teaching me very early on that marketing strategy is looking for needles in haystacks.

It's different than most other businesses most other therapeutic areas you go see a physician because the patients go to the physician and. In rare diseases, you have to go find the patient. <unk>.

In rare diseases, you have to go find the patient. <unk>.

<unk>.

I remember at Genzyme someone in marketing teaching me very early on that marketing strategy is looking for needles in haystacks.

And that actually becomes a core competency and that's one of the areas that we have to go after. There's been an awful lot of easier to find patients who are more serious than we're naturally visiting physicians, but there are for instance, adult patients who are difficult to diagnose and so looking at increasing the patient numbers means that we're going to have to be good at rare diseases. And once you have that core competency, in my view you can be in are disease, and you can be therapy or indication agnostic in that area. So that's where we're starting because I think we can execute in those areas. Could that be acquisition, could be late stage in licensing, we can look at all of the above. And look, Biogen hasn't necessarily looked at acquisitions as part of its growth strategy. Equally, I tell people, there wasn't a lot of point hiring me if you don't want to go do deals. So it's not to say we are, but I think there is now an openness within the company to at least look at it now. As we all know M&A is hard to execute on and get something that is truly accretive and generates a return on investment and that's why we are really focused first and foremost on driving the most that we can out of organic growth. But I would say that we are open to anything in those four areas that I mentioned before.

And that actually becomes a core competency and that's one of the areas that we have to go after.

There's been an awful lot of easier to find patients who are more serious than we're naturally visiting physicians, but there are for instance, adult patients who are difficult to diagnose and so looking at increasing the patient numbers means that we're going to have to be good at rare diseases. And once you have that core competency, in my view you can be in are disease, and you can be therapy or indication agnostic in that area. So that's where we're starting because I think we can execute in those areas. Could that be acquisition, could be late stage in licensing, we can look at all of the above. And look, Biogen hasn't necessarily looked at acquisitions as part of its growth strategy. Equally, I tell people, there wasn't a lot of point hiring me if you don't want to go do deals. So it's not to say we are, but I think there is now an openness within the company to at least look at it now. As we all know M&A is hard to execute on and get something that is truly accretive and generates a return on investment and that's why we are really focused first and foremost on driving the most that we can out of organic growth. But I would say that we are open to anything in those four areas that I mentioned before.

Easier to find patients who are more serious than we're naturally visiting physicians, but there are for instance, adult patients who are difficult to diagnose and so looking at increasing the patient numbers means that we're going to have to be good at rare diseases and once you have that core competency in my view you can be in. Rare disease, and you can be therapy or indication agnostic in that area. So that's where we're starting because I think we can execute in those areas. Could that be acquisition could be late stage in licensing we can look at all of the above. Yes. And I look. It hasnt necessarily looked at acquisitions. As part of its growth strategy. Equally I would say. People. There wasn't a lot of point hiring me if you don't want to go do deals. So it's not to say we are but I think there is now an openness within the company to at least look at it now. As we all know M&A is hard to execute on and get something that is truly accretive and generates a return on investment and that's why we are really focused first and foremost on driving the most that we can amount of organic growth, but I would say that. We are open to anything in those those four areas. I mentioned before.

Rare disease, and you can be therapy or indication agnostic in that area. So that's where we're starting because I think we can execute in those areas. Could that be acquisition could be late stage in licensing we can look at all of the above. Yes. And I look. It hasnt necessarily looked at acquisitions. As part of its growth strategy. Equally I would say. People. There wasn't a lot of point hiring me if you don't want to go do deals. So it's not to say we are but I think there is now an openness within the company to at least look at it now. As we all know M&A is hard to execute on and get something that is truly accretive and generates a return on investment and that's why we are really focused first and foremost on driving the most that we can amount of organic growth, but I would say that. We are open to anything in those those four areas. I mentioned before.

Could that be acquisition could be late stage in licensing we can look at all of the above. Yes. And I look. It hasnt necessarily looked at acquisitions. As part of its growth strategy. Equally I would say. People. There wasn't a lot of point hiring me if you don't want to go do deals. So it's not to say we are but I think there is now an openness within the company to at least look at it now. As we all know M&A is hard to execute on and get something that is truly accretive and generates a return on investment and that's why we are really focused first and foremost on driving the most that we can amount of organic growth, but I would say that. We are open to anything in those those four areas. I mentioned before.

Yes. And I look. It hasnt necessarily looked at acquisitions. As part of its growth strategy. Equally I would say. People. There wasn't a lot of point hiring me if you don't want to go do deals. So it's not to say we are but I think there is now an openness within the company to at least look at it now. As we all know M&A is hard to execute on and get something that is truly accretive and generates a return on investment and that's why we are really focused first and foremost on driving the most that we can amount of organic growth, but I would say that. We are open to anything in those those four areas. I mentioned before.

And I look. It hasnt necessarily looked at acquisitions. As part of its growth strategy. Equally I would say. People. There wasn't a lot of point hiring me if you don't want to go do deals. So it's not to say we are but I think there is now an openness within the company to at least look at it now. As we all know M&A is hard to execute on and get something that is truly accretive and generates a return on investment and that's why we are really focused first and foremost on driving the most that we can amount of organic growth, but I would say that. We are open to anything in those those four areas. I mentioned before.

It hasnt necessarily looked at acquisitions. As part of its growth strategy. Equally I would say. People. There wasn't a lot of point hiring me if you don't want to go do deals. So it's not to say we are but I think there is now an openness within the company to at least look at it now. As we all know M&A is hard to execute on and get something that is truly accretive and generates a return on investment and that's why we are really focused first and foremost on driving the most that we can amount of organic growth, but I would say that. We are open to anything in those those four areas. I mentioned before.

As part of its growth strategy. Equally I would say. People. There wasn't a lot of point hiring me if you don't want to go do deals. So it's not to say we are but I think there is now an openness within the company to at least look at it now. As we all know M&A is hard to execute on and get something that is truly accretive and generates a return on investment and that's why we are really focused first and foremost on driving the most that we can amount of organic growth, but I would say that. We are open to anything in those those four areas. I mentioned before.

Equally I would say. People. There wasn't a lot of point hiring me if you don't want to go do deals. So it's not to say we are but I think there is now an openness within the company to at least look at it now. As we all know M&A is hard to execute on and get something that is truly accretive and generates a return on investment and that's why we are really focused first and foremost on driving the most that we can amount of organic growth, but I would say that. We are open to anything in those those four areas. I mentioned before.

People. There wasn't a lot of point hiring me if you don't want to go do deals. So it's not to say we are but I think there is now an openness within the company to at least look at it now. As we all know M&A is hard to execute on and get something that is truly accretive and generates a return on investment and that's why we are really focused first and foremost on driving the most that we can amount of organic growth, but I would say that. We are open to anything in those those four areas. I mentioned before.

There wasn't a lot of point hiring me if you don't want to go do deals. So it's not to say we are but I think there is now an openness within the company to at least look at it now. As we all know M&A is hard to execute on and get something that is truly accretive and generates a return on investment and that's why we are really focused first and foremost on driving the most that we can amount of organic growth, but I would say that. We are open to anything in those those four areas. I mentioned before.

So it's not to say we are but I think there is now an openness within the company to at least look at it now. As we all know M&A is hard to execute on and get something that is truly accretive and generates a return on investment and that's why we are really focused first and foremost on driving the most that we can amount of organic growth, but I would say that. We are open to anything in those those four areas. I mentioned before.

As we all know M&A is hard to execute on and get something that is truly accretive and generates a return on investment and that's why we are really focused first and foremost on driving the most that we can amount of organic growth, but I would say that. We are open to anything in those those four areas. I mentioned before.

We are open to anything in those those four areas. I mentioned before.

I mentioned before.

Michael R. McDonnell: And I'll just quickly add Evan to your question on size of deals without commenting on how large a deal we might do or series of deals just in terms of aggregate capacity, we mentioned upfront we ended the year with $5.6 billion in cash, we have more coming in from Samsung in the early second quarter of this year and we have a modest amount of debt. So you can pretty quickly get close to a better part of $10 billion of capacity number that we can utilize in a variety of ways. Point out the amount of money we're getting still from Samsung that is yet to come in. $800 million that's coming in April and then another 400 plus that will come in next year. Firepower is not necessarily the main constraint, finding something that's worthwhile doing is the really hard part of this.

Michael R. McDonnell: And I'll just quickly add Evan to your question on size of deals without commenting on how large a deal we might do or series of deals just in terms of aggregate capacity, we mentioned upfront we ended the year with $5.6 billion in cash, we have more coming in from Samsung in the early second quarter of this year and we have a modest amount of debt. So you can pretty quickly get close to a better part of $10 billion of capacity number that we can utilize in a variety of ways.

We mentioned upfront we ended the year with $5 6 billion in cash we have more coming in from Samsung. In the early second quarter of this year. And we have a modest amount of debt. So you can pretty quickly get to close to better part of $10 billion of. Capacity number. We can utilize in a variety of ways. Pointed out the amount of money, we're getting still from Samsung. That is yet to come in $800 million that's coming in. In April and then another 400 plus that will come in next year. Casino firepower is not necessarily the main constraint finding something that's worthwhile doing is the really hard part of this.

In the early second quarter of this year. And we have a modest amount of debt. So you can pretty quickly get to close to better part of $10 billion of. Capacity number. We can utilize in a variety of ways. Pointed out the amount of money, we're getting still from Samsung. That is yet to come in $800 million that's coming in. In April and then another 400 plus that will come in next year. Casino firepower is not necessarily the main constraint finding something that's worthwhile doing is the really hard part of this.

And we have a modest amount of debt. So you can pretty quickly get to close to better part of $10 billion of. Capacity number. We can utilize in a variety of ways. Pointed out the amount of money, we're getting still from Samsung. That is yet to come in $800 million that's coming in. In April and then another 400 plus that will come in next year. Casino firepower is not necessarily the main constraint finding something that's worthwhile doing is the really hard part of this.

Capacity number. We can utilize in a variety of ways. Pointed out the amount of money, we're getting still from Samsung. That is yet to come in $800 million that's coming in. In April and then another 400 plus that will come in next year. Casino firepower is not necessarily the main constraint finding something that's worthwhile doing is the really hard part of this.

We can utilize in a variety of ways. Pointed out the amount of money, we're getting still from Samsung. That is yet to come in $800 million that's coming in. In April and then another 400 plus that will come in next year. Casino firepower is not necessarily the main constraint finding something that's worthwhile doing is the really hard part of this.

Pointed out the amount of money, we're getting still from Samsung. That is yet to come in $800 million that's coming in. In April and then another 400 plus that will come in next year. Casino firepower is not necessarily the main constraint finding something that's worthwhile doing is the really hard part of this.

Christopher A. Viehbacher: Point out the amount of money we're getting still from Samsung that is yet to come in. $800 million that's coming in April and then another 400 plus that will come in next year. Firepower is not necessarily the main constraint, finding something that's worthwhile doing is the really hard part of this.

Christopher A. Viehbacher: Point out the amount of money we're getting still from Samsung that is yet to come in.

That is yet to come in $800 million that's coming in. In April and then another 400 plus that will come in next year. Casino firepower is not necessarily the main constraint finding something that's worthwhile doing is the really hard part of this.

Michael R. McDonnell: $800 million that's coming in April and then another 400 plus that will come in next year. Firepower is not necessarily the main constraint, finding something that's worthwhile doing is the really hard part of this.

Michael R. McDonnell: $800 million that's coming in April and then another 400 plus that will come in next year.

In April and then another 400 plus that will come in next year. Casino firepower is not necessarily the main constraint finding something that's worthwhile doing is the really hard part of this.

Casino firepower is not necessarily the main constraint finding something that's worthwhile doing is the really hard part of this.

Christopher A. Viehbacher: Firepower is not necessarily the main constraint, finding something that's worthwhile doing is the really hard part of this.

Operator: We will now move to Tim Anderson of Wolfe Research.

We will now move to Tim Anderson of Wolfe Research.

Tim Anderson: Thank you. A couple of questions on [inaudible] and the sub Q. Can you just confirm what the minimum regulatory requirements are for approval of the sub Q in terms of what you need to show in the data you're currently capturing? And do you think there's any meaningful risk in gathering that necessary data? To me the long term commercial future of the brand really hinges on having a sub Q and I'm trying to gauge whether there is any meaningful risk that we should be cognizant of. Thank you.

In terms of what you need to show in the data you're currently capturing.

And do you think theres any meaningful risk and gathering that necessary data to me the long term commercial future of the brand really hinges on having a sub Q and im trying to gauge whether there is any meaningful risk that we should be cognizant. Thank you.

Priya Singhal: I can take that, thanks for that question. I think overall, I just want to reiterate that Eisai is studying subcutaneous in the phase III open label extension and actually details of that sub-study are public, you can take a look at that. Eisai has also communicated that they believe that they have had the regulatory discussions to embark upon this pathway. But beyond that, it would be speculative to say what are the minimum requirements. I think we do have regulatory discussions ongoing and a lot as you know is always dependent on the data as it gets generated. Overall, Eisai has communicated that they expect to filed by Q1 2024.

I just want to reiterate that ESI is studying subcutaneous in the phase III open label extension and actually details of that study are public you can take a look at that <unk> also communicated that they believe that they have had the regulatory discussions.

<unk>.

Embark upon this pathway.

But beyond that it would be speculative to say what are the minimum requirements. I think we do have regulatory discussions ongoing and a lot. As you know is always dependent on the data as it gets generated overall ESI has communicated that they will be expect to filed by Q1 2024.

And then stepping back to what is the true potential, I'll just draw us back to the data that we saw from the clarity ED study, which was of course utilizing the intravenous by monthly dosing regimen. I think the most important part there was that we saw the amyloid reduction at six months expanding over the 18 month period. We had a positive primary endpoint with a highly statistically significant P value as well as all of the secondary endpoints. So we believe that really clarity ED is quite clear in its outcome and we believe that the data are meaningful and can have an impact on the patient population. The subcutaneous formulation is really our approach to kind of thinking about this more comprehensively. So we believe it has a lot of potential and then of course, we will continue to build on what is the dosing maintenance dosing as well as subcutaneous. And as Chris mentioned what is the application of an anti amyloid therapy in pre-symptomatic or preclinical Alzheimer's disease.

I'll just draw us back to the data that we saw from the clarity study, which was of course utilizing the intravenous bye.

By monthly.

All right.

Judy dosing regimen I think the most important part there was that we saw the amyloid reduction at six months expanding over the 18 month period.

Had a positive primary endpoint with a highly statistically significant P value as well as all of the secondary endpoints. So we believe that really clarity EDI is quite clear and its outcome and we believe that the data are meaningful.

Can have an impact on the patient population. The subcutaneous formulation is really our approach to kind of thinking about this more comprehensively. So we believe as it has a lot of potential and then of course, we will continue to build on what is the dosing maintenance dosing as well as subcutaneous and as Chris mentioned what is the.

<unk> of an anti amyloid pet be in <unk>. Symptomatic of preclinical Alzheimer's disease.

Symptomatic of preclinical Alzheimer's disease.

Michael R. McDonnell: Tim, the way I look at this is I think what we're going to see over time is that you're going to have a plaque removal phases of treatment and then a maintenance. In the short term, we can talk about potential for sub Q, but really I would say for the next two to three years, the demand for the product is probably more limited by capacity of the system to actually diagnose and treat patients. So an IV will be the port for the convenience of patients, but I'm not sure that short term it is really going to have that much impact on demand.

I think what we're going to see over time is that youre going to have a plaque removal phases of treatment and then a maintenance. In the short term, we can talk about potential for sub Q, but really.

In the short term, we can talk about potential for sub Q, but really.

I would say for the next two to three years the demand for the product is probably more limited by capacity of the system to vaccine dire.

Diagnose and treat patients.

No.

And IV will be.

For the convenience of patients, but im not sure that short term it is.

One game changer I think to me is blood biomarkers. If we can eliminate the pet scans and in particular, the lumbar puncture, this will make it a whole lot easier for the whole medical community to at least get the diagnosis and we can probably reduce the overall treatment cost of a patient. Those blood biomarkers have been around for some time, but until there was a treatment, there wasn't a commercial market for those diagnostics. So to me, the biggest game changer that could occur is if we can get some of these blood diagnostics to market sooner. they're probably still a couple of years away but there is important in my mind commercially as a sub Q.

To me is.

As blood Biomarkers.

If we can eliminate the pet scans and in particular, the lumbar puncture.

This will make it a whole lot easier for the whole medical community to at least get the diagnosis and we can probably reduce the overall treatment cost of a.

Patient those blood biomarkers have been around for some time.

But until there was a treatment there wasn't a commercial market for those diagnostics. So to me the biggest game changes that could occur is if we can get some of these blood diagnostics.

Market sooner.

It's probably still a couple of years away.

There is important in my mind commercially as a sub Q.

Operator: We will now take a question from Brian Abrahams from RBC Capital Markets.

BC capital markets.

Brian Corey Abrahams: Hey, good morning, thanks for taking my question. On [inaudible], as you consider the maintenance therapy, what's the right way we should be thinking about the potential balance of annual per patient price declines versus the potential for market expansion in greater durability for chronic use? Thanks.

Hey, good morning, Thanks for taking my question.

On the can be as you consider the maintenance therapy, what's the right way, we should be thinking about the potential balance of annual per patient price declines versus the potential for market expansion in greater durability for chronic use.

Yeah.

Christopher A. Viehbacher: You mean, the price decline related to maintenance is that what you're saying?

Brian Corey Abrahams: I guess, how are you thinking about pricing strategically for a maintenance therapy on an annualized basis relative to the every two week and how should we think about the overall balance?

Two the every two week and how should we think about the overall balance.

Christopher A. Viehbacher: Again, I think obviously, we have to wait and see the data and get approval for these things, but I think you're probably going to be in this plaque removal process and that's the every two weeks. As you get into maintenance as Priya said, the dosing regimen could change, and obviously if you were to go from two weeks to one month, that has an overall per patient cost on an annualized basis that would be lower. So I think you'll see potentially a lower patient cost just because of the different dosing regimen over time. Shorter term again, I think we probably have more patients out there than the system can manage. And so I don't think there's going to be that much price pressure. Once the system adapts, there may be overtime, but I don't really see prices being the main aspect of this.

Obviously, we have to wait and see the data and get approval for these things but.

I think you're probably going to be in this plaque removal process and thats. The every two weeks.

You get into maintenance as <unk> said, the dosing regimen could change and obviously if you were to go from two weeks to one month.

That has a has an overall per patient cost on an annualized basis that would be lower so so I think you'll see potentially a lower patient cost just because of the different dosing regimen over time.

Shorter term again, I think we probably have more patients out there than the system can manage.

And so I don't think theres going to be that much.

Rice pressure once once the system adapts.

There may be overtime, but I don't really see prices being the main aspect of this and remember.

And remember when you look at this, I mean, we're talking about $26,500 for the drug costs, but there's a lot more cost to the system for the treatment of patients. A pet scan for instance costs around $7000 as an example, and you have the MRIs and treatment. And that's why to me blood diagnostics could play a bigger role in actually reducing the overall cost. And I think those types of things and as we move into maintenance dosing regimens, we may find that the average annual cost to the patient goes down although we're not necessarily touching the price of the drug.

I mean, we're talking about $26500 for the drug costs. There's a lot more.

There's a lot more.

Cost to the system for the treatment of patients of a pet scan for instance costs around $7000 as an example.

And you have the treatment and that's why to me blood diagnostics could play a bigger role in actually reducing the overall cost.

I think those types of things and as we move into maintenance dosing regimens. We may find that the average annual cost to the patient goes down although we're not necessarily touching the price of the drug.

Operator: We will now take a question from Mike Hickey of Jefferies. Please go ahead.

Mike Hickey: Hey, thanks for the question. Chris, it's great to hear from you. You mentioned in the slides that you would like to improve the risk profile and productivity R&D pipeline, particularly [inaudible] profile. And I recall in January you talked about lower risk type projects, and perhaps Biogen's too high risk, high reward, particularly for this market cap. And then going back to your prior days you did I think the Genzyme beyond the Regeneron deal. So can you just comment about the philosophy of bringing in products that are perhaps lower risk, more de risked and how you think about bringing those in and acting on those accordingly and with speed? Thank you.

Alright, thanks for the question.

Chris it's great to hear from you.

You mentioned in the slides that you would like to improve the risk profile and productivity R&D pipeline, particularly.

And I recall in January you talked about lower risk.

Type projects, and perhaps biogen's, two high risk high reward, particularly for this market cap. And then going back to Europe . Prior days you did I think the genzyme beyond the Regeneron deal. So can you just comment. The philosophy of bringing in products that are perhaps lower risk more de risked and how you think about bringing those in. Cannot calendars accordingly. The speed thank you.

And then going back to Europe . Prior days you did I think the genzyme beyond the Regeneron deal. So can you just comment. The philosophy of bringing in products that are perhaps lower risk more de risked and how you think about bringing those in. Cannot calendars accordingly. The speed thank you.

Prior days you did I think the genzyme beyond the Regeneron deal. So can you just comment. The philosophy of bringing in products that are perhaps lower risk more de risked and how you think about bringing those in. Cannot calendars accordingly. The speed thank you.

The philosophy of bringing in products that are perhaps lower risk more de risked and how you think about bringing those in. Cannot calendars accordingly. The speed thank you.

Cannot calendars accordingly. The speed thank you.

The speed thank you.

Christopher A. Viehbacher: Sure. To me, risk management is something that is part of the day job in a pharma company. You obviously can't do anything unless you take risk. We develop products in early stage. If you're talking about phase one, you've got 10% probability of success. I think there's a couple of areas that we would look at.

To me.

Risk management is something that is as part of the day job and a pharma company obviously.

Do anything unless you take risk.

We develop products in early stage.

If you're talking about phase one you've got 10% probability of success.

I think there's a couple of areas that we would look at the first thing is.

The first thing is, obviously, if you can do a phase II study where you get a lot of confidence out of safety and efficacy before you go into a phase III study, you have essentially at every stage of development from phase one to phase II, phase II to phase III derisked that. We sometimes can't do it. And if you look at Alzheimer's and the development of either [inaudible], you can start to see for instance that you're reducing plaque but one of the problems a lot of companies had is they didn't reduce the plaque enough. And you're not going to know whether you have reduced the plaque enough until you see a benefit in cognitive function, but you really can't do that until you go into large studies and take a long time, because these diseases progress so slowly. So to me, one of the areas, if you go into autoimmune diseases or into psychiatry,

The first thing is, obviously, if you can do a phase II study where you get a lot of confidence out of safety and efficacy before you go into a phase III study, you have essentially at every stage of development from phase one to phase II, phase II to phase III derisked that. We sometimes can't do it. And if you look at Alzheimer's and the development of either [inaudible], you can start to see for instance that you're reducing plaque but one of the problems a lot of companies had is they didn't reduce the plaque enough. And you're not going to know whether you have reduced the plaque enough until you see a benefit in cognitive function, but you really can't do that until you go into large studies and take a long time, because these diseases progress so slowly.

Have essentially at every stage of development from phase one to phase III phase II to phase III derisk that.

We sometimes can't do and if you look at Alzheimer's.

And the development of either Mckenna member add him.

Sure.

You can you can start to see for instance that you're reducing plaque but one of the problems we have.

A lot of companies had is they didn't reduce the plaque enough.

And.

Youre not going to know whether you have reduced the plaque enough until you see a benefit in cognitive function, but you really can't do that until you go into large studies and take a long time, because these diseases progress. So slowly so to me one of the areas that we can if you go into autoimmune diseases or your interest.

So to me, one of the areas, if you go into autoimmune diseases or into psychiatry, you can have a more classical drug development where you can derisk more in phase II you can get a proof of concept. As I said earlier, we are sometimes doing proof of concept in phase III, which is an expensive way to do proof of concept. So just even thinking about moving into some of these other areas allows us to do more classical drug development. The other is of course that we can start to license in products that are a lot closer to market and you're not taking quite as much risk on those, but it's really a function of when you look at it how much are precedented versus unprecedented mechanisms of action, how much are small molecules versus large molecules? Can we do more collaborative types of approaches? But this notion of always doing proof of concept in phase III is a highly expensive, highly risky approach. And I think having a few of those projects in our pipeline is good, having 100% of our pipeline and projects like that is challenging. And if you look at it, we don't really have an approval coming in our pipeline for several years yet here because we're waiting on these long term studies, so having things that readout on a little bit more frequent basis would be helpful to looking at sustainable growth of the company.

you can have a more classical drug development where you can derisk more in phase II you can get a proof of concept. As I said earlier, we are sometimes doing proof of concept in phase III, which is an expensive way to do proof of concept. So just even thinking about moving into some of these other areas allows us to do more classical drug development. The other is of course that we can start to license in products that are a lot closer to market and you're not taking quite as much risk on those, but it's really a function of when you look at it how much are precedented versus unprecedented mechanisms of action, how much are small molecules versus large molecules? Can we do more collaborative types of approaches? But this notion of always doing proof of concept in phase III is a highly expensive, highly risky approach. And I think having a few of those projects in our pipeline is good, having 100% of our pipeline and projects like that is challenging. And if you look at it, we don't really have an approval coming in our pipeline for several years yet here because we're waiting on these long term studies, so having things that readout on a little bit more frequent basis would be helpful to looking at sustainable growth of the company.

Are there areas allows us to do more classical drug development. The other is of course that we can start.

License in products and.

There are a lot closer to market and youre not taking quite as much risk on those but it's really a function of when you look at it. How much are precedented versus unprecedented mechanism of action how much of small molecules. Versus large molecules can we do more collaborative types of approaches but. This notion of always doing proof of concept in phase III is a highly expensive highly risky approach. And I think having a few of those projects in our pipeline is good having 100% of our pipeline and projects like that. This is challenging. And if you look at it we don't really have an approval. Coming in our pipeline for several years, yet here because we're waiting on these long term studies, so so having things that readout on a little bit. A more frequent basis would be helpful too looking at sustainable growth of the company.

How much are precedented versus unprecedented mechanism of action how much of small molecules. Versus large molecules can we do more collaborative types of approaches but. This notion of always doing proof of concept in phase III is a highly expensive highly risky approach. And I think having a few of those projects in our pipeline is good having 100% of our pipeline and projects like that. This is challenging. And if you look at it we don't really have an approval. Coming in our pipeline for several years, yet here because we're waiting on these long term studies, so so having things that readout on a little bit. A more frequent basis would be helpful too looking at sustainable growth of the company.

Versus large molecules can we do more collaborative types of approaches but. This notion of always doing proof of concept in phase III is a highly expensive highly risky approach. And I think having a few of those projects in our pipeline is good having 100% of our pipeline and projects like that. This is challenging. And if you look at it we don't really have an approval. Coming in our pipeline for several years, yet here because we're waiting on these long term studies, so so having things that readout on a little bit. A more frequent basis would be helpful too looking at sustainable growth of the company.

This notion of always doing proof of concept in phase III is a highly expensive highly risky approach. And I think having a few of those projects in our pipeline is good having 100% of our pipeline and projects like that. This is challenging. And if you look at it we don't really have an approval. Coming in our pipeline for several years, yet here because we're waiting on these long term studies, so so having things that readout on a little bit. A more frequent basis would be helpful too looking at sustainable growth of the company.

And I think having a few of those projects in our pipeline is good having 100% of our pipeline and projects like that. This is challenging. And if you look at it we don't really have an approval. Coming in our pipeline for several years, yet here because we're waiting on these long term studies, so so having things that readout on a little bit. A more frequent basis would be helpful too looking at sustainable growth of the company.

This is challenging. And if you look at it we don't really have an approval. Coming in our pipeline for several years, yet here because we're waiting on these long term studies, so so having things that readout on a little bit. A more frequent basis would be helpful too looking at sustainable growth of the company.

And if you look at it we don't really have an approval. Coming in our pipeline for several years, yet here because we're waiting on these long term studies, so so having things that readout on a little bit. A more frequent basis would be helpful too looking at sustainable growth of the company.

Coming in our pipeline for several years, yet here because we're waiting on these long term studies, so so having things that readout on a little bit. A more frequent basis would be helpful too looking at sustainable growth of the company.

A more frequent basis would be helpful too looking at sustainable growth of the company.

Michael R. McDonnell: Operator, I think we have time for one final question.

Operator: Thank you. Our next question comes from Chris Schott of JP Morgan.

Chris Schott: Great, thanks so much. Just another one on BD, is this something you are going to be looking to do in parallel with your strategic review and costs resizing efforts or is this a bit of a longer term priority once you make whatever changes are necessary for the core business?

And maybe just as a second part of that same question, given your prior comments of the narrow focus of Biogen, does that point more towards BD skewed towards either company acquisitions versus partnerships earlier stage deals because it seems like you might want to be bringing both products as well as kind of expertise in house. Just help me a little bit in terms of how you think about that dynamic. Thank you.

Does that point more towards BD skewed towards either company acquisitions versus partnerships earlier stage deals as it seems like you might want to be bringing both products as well as kind of expertise in house.

Just help me a little bit in terms of like the.

How do you think about that dynamic thank you.

Christopher A. Viehbacher: I think certainly for the first half of this year, we're focused on really reorienting the company towards these growth opportunities, looking at the cost base we should have a new head of research in that timeframe. We're also in the process of recruiting a head of BD. So to me this is sort of something that we start to look at in the second half of the year. As you know it takes a while to go find things you've got to look at a lot of things before you do something. So even if you decided you wanted to do something next year, you really have to start looking now. In terms of what we're looking at, look, it could be all of the above to the degree that we get comfortable with the launch trajectory of [inaudible] you could argue that the bankers like to refer to this desperation factor. I would argue that we don't have a high desperation factor. We actually have a lot that we can do within the company. I think it's healthy to be looking outside and to always have options because in this business nothing ever goes completely to plan. But we have the time to look and make sure that whatever we do is going to be value added and I think it could be all of the things that you've mentioned.

Growth opportunities looking at the cost base.

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We should have a new head of research in that timeframe. We're also in the process of recruiting ahead of BD.

So to me this is sort of something that we start to look at in the second half of the year as you know it takes a while to go find things you've got to look at a lot of things before you do something so even if you decided you wanted to do something next year, you really have to start looking now in terms of what we're looking at.

Look it could be all of the above.

The degree that we get comfortable with the launch trajectory of.

<unk> can be an zarin alone you could argue that.

The bankers like to refer to this desperation factor.

Argue that we don't have a high desperation factor, we actually have a lot that we can do within the company. I think it's healthy to be looking outside and to always have. Options because. And this business nothing ever goes completely to plan. But we have the time to look and make sure that whatever we do is going to be value added I think it could be all of the things that you've mentioned.

I think it's healthy to be looking outside and to always have. Options because. And this business nothing ever goes completely to plan. But we have the time to look and make sure that whatever we do is going to be value added I think it could be all of the things that you've mentioned.

Options because. And this business nothing ever goes completely to plan. But we have the time to look and make sure that whatever we do is going to be value added I think it could be all of the things that you've mentioned.

And this business nothing ever goes completely to plan. But we have the time to look and make sure that whatever we do is going to be value added I think it could be all of the things that you've mentioned.

But we have the time to look and make sure that whatever we do is going to be value added I think it could be all of the things that you've mentioned.

Michael R. McDonnell: Okay, with that, I think we're going to conclude the call for today. Thank you everyone for joining us.

Operator: This concludes today's call. Thank you for your participation, you may now disconnect.