Biogen Inc. (BIIB) Earnings Call Transcript & Summary

All right. Good afternoon, everyone. My name is Cory Kasimov. I'm the senior large cap biotech analyst at JPMorgan, and it's my pleasure to introduce our next company, Biogen. Obviously, looking at a very important 2020 and here to tell us about it is the company's CEO, Michel Vounatsos. And please note that following Michel's presentation is a breakout just down the hall in the [ Georgian ] room. With that, I'll turn it over to Michel.

Thank you so much. Good afternoon, everyone. I hope you're doing well. It's a pleasure being here and having the opportunity to give you an update on our progress at Biogen on the way to build a multifranchise portfolio focusing on neuroscience and the huge opportunity it offers. I fundamentally believe that Biogen is facing a clear inflection points with many near-term opportunities obviously in the field of Alzheimer's disease with a decision to go to file, but also in stroke, in lupus, in ALS, in ophthalmology. So this pipeline is maturing well, and we didn't take any shortcut, but it's coming up with obviously the key opportunity being aducanumab filing and eventually launch, if approved. I'll be making some forward-looking statements that contain risks and uncertainties. I kindly refer you back to our SEC filing. Our mission is to pioneer a science for in order to best serve humanity. And the question we ask ourselves all the time is, is it good for the patients? Is it good for the society that we want to serve? This is the purpose that is so important for our company. So again, our mission is to develop and commercialize transformational medicines. But the key question is, are we pioneer in that space? I believe we are, and this is what I will try to communicate in the coming seconds, starting with the magnitude of the epidemiology. I believe the time is now for neuroscience. It's the #1 cause of disability globally. It's only the #2 cause of death after cardiovascular diseases. We do have a $9 billion franchise in MS and approximately a $2 billion on SPINRAZA. But the near-term opportunities and for those unmet medical need remains and opportunity remains. But the near-term opportunities to create value for the shareholders and for the patients first are tremendous. 50 million patients demented. 50% of those will evolve towards Alzheimer's disease; in ALS; in stroke, for which there was no innovation since many, many years; and again, in ophtha. So we are very encouraged because we believe that Biogen can meet those opportunities while serving the patients. The latest example, the most recent example is certainly the good news on aducanumab. Some of you were at CTAD and saw the data. Who in the room doesn't know someone who's demented or he's exposed to this dramatic disease called Alzheimer's? In context, during the next 25 minutes, there will be 25 new patients in this country only affected by Alzheimer's. Alzheimer's cost today $0.5 trillion to the U.S., will be much more by 2050. Aging society is going strong. There will be 1.5 billion citizens by 2030 above the age of 60, and we know that this is clearly related to the epidemiology, for which there is no treatment today. And if only we were able to delay the full onset of the disease by 5 years, and this is documented in the literature, we will be eventually in a position to decrease the prevalence by 40% and the cost by 40% by 2050. This is tremendous. And obviously, it offers the opportunity for pharmacoeconomic study on why an intervention such as potentially aducanumab could serve the patient, the society in which we live. We are obviously very encouraged also by the portfolio, including BAN2401 that has the closest binding similarities as aducanumab, but also the anti-tau directed assets and novel preclinical programs like the CAMP4 agreements that we had lately, and also some innovative symptomatic treatment like the announcements that we've made today. A full commitment of the organization for this very large unmet medical need, and this is our priority, and certainly, the most, I will say, obvious inflection point for the organization. And we are working on that very diligently at Biogen. And I want to compliment the Biogen team because without all the protocol amendments, I will not be here today standing with a smile of confidence on the way forward. The epidemiology related to our study is very large in the U.S. More than 10 million patients in this country only if we look at the entry criteria of our study. And moving forward, we plan to go more towards the left for earlier intervention, preclinical or secondary prevention for a larger population. We want -- we aim at leading in a sustained fashion in Alzheimer, and we're going to invest what it takes. Biogen, being highly specialized in neuroscience, is benefiting from the interconnectivity within that space in order to build asymmetric capabilities beyond the programs on which we invest. And here are some of those: the biomarker with amyloid, but beyond amyloid, also tau. And again, I want to compliment my team for looking at the tau as a biomarker on the aducanumab study, and I will not come back on that. But also the human genetics. We know the correlation, the modalities. It was a dream to think about a large molecule that will pass the blood-brain barrier at therapeutic dose will erode the plaque and will eventually slow down the erosion of cognition. The patient selection, obviously if you want to have the right studies with the probability of success, and very importantly, a fine understanding of the biology, the binding characteristic to the aggregated form of amyloid beta. This is absolutely critical if we want to erode the plaque. This is the monomeric form that others were binding to. And again, BAN2401 is the closest. Last but not least, the respect, the transparent engagement with the regulator all around the world, starting with the U.S. FDA. Those asymmetric capabilities due to the interconnectivity are relevant for many programs beyond aducanumab. And here, in the case of biomarkers for target engagement, and this is activity that gives the early signal, is critical. And 2 examples, again, beyond aducanumab, one in ALS, for which we communicated a year ago the positive Phase I/II study for the SOD1, superoxide dismutase-1, protein, the toxic protein that we aim at decreasing; and obviously, the biomarker as a marker of disease activity that we measure in this study now in Phase III with a readout in 2021. The portfolio is maturing. Another example is glibenclamide IV for large hemispheric stroke. We are very encouraged with the Phase II data with some mortality data, too; and the midline shift also signal due to the edema in the brain following those strokes; and all the programs on the bottom left. Pursuing genetically validated targets beyond aducanumab is also extremely relevant. And again, a couple of examples. In that case, it is C9orf72, which is a larger population of familial cause or genetic cause of ALS; and BIIB054 alpha-synuclein Parkinson's, for which we expect some data this year, and we are encouraged. Again, a study shows that when we conduct studies for genetically validated targets, we have a POS that increases by twofold. So it was also a conscious decision by the organization and the leadership of the R&D to rebalance the risk by increasing the number of programs for genetically validated diseases. Leveraging the multiple modalities. Obviously, this is probably the best way to tackle a disease, and Biogen is absolutely agnostic of any of those, even if we have capabilities more for larger molecules, but also in the case of choroideremia, in the acquisition we made with Nightstar gene therapy, antisense oligonucleotide for BIIB094 LRRK2 in Parkinson's and others like the oral protein integrators and more on the left side. But partnerships are critical here because we cannot master everything in-house. We need also to excel in partnership. But once you have asymmetric capabilities, experience and a focus -- fully-integrated focus in neuroscience from the early hour to the development and commercialization, you eventually are in a position to attract the best partners. I am very pleased to report on a successful study that we communicated a few weeks back. This is the in-house discovered and developed BIIB059, BDCA2, which is the first in a new class for lupus Phase II positive results with the decision to move to Phase III. Once more, this pipeline is maturing. The market opportunity is very large. And we are pleased with those results. Mortality eventually for the systemic case of lupus. This is the broad pipeline that I am pleased to show with 6 program in Phase III, 12 in Phase II and 9 in Phase I and many readouts in the next 18 months, 11 readouts. So we have materially increased the depth and the breadth of the pipeline. And we continue to work diligently at bolstering this pipeline, the announcement that we've made, but also the one for -- with Catalyst on geographic atrophy for dry AMD, macular degenerations. So again, this is the focus of the organization, but with some material improvement during the past period. We increased the breadth and the depth. We are progressing towards creating multiple franchises. We have 10 readouts in the coming period. Are we the leader in neuroscience? I fundamentally believe we are. If you add to that -- to those elements, the asymmetric capabilities and the talent of neuro-clinicians, neuroscientists and the engagement and the experience with the physician, it positions Biogen uniquely in that space where the unmet medical need is so tremendous. So now the key question is, is Biogen able to implement and generate the value commercially out of this productivity of the pipeline? And yes, Biogen has demonstrated the ability to compete on a $9 billion franchise while the number of DMTs increased dramatically during that period. So this is an excellent performance. That was questioned at the beginning of the period. Flawless execution, the ability to compete and to lead for this critical franchise with significant cash flow generation. We are nowadays launching VUMERITY. And we continue to invest in MS because unmet medical need remains very high. We have obviously the extended interval dose for TYSABRI; the remuneration compounds with opicinumab and BIIB061; and market event opportunities with interferons; and last but not least, the oral BTK inhibitor. Strong ability to compete, which is very important in nowadays environment. Biogen has demonstrated the ability to implement well and to deliver a blockbuster launch for SPINRAZA. It was not foreseen. It was questioned. Well, it's now close to a $2 billion product, more than 10,000 patients, ability to launch, ability to lead, ability to access in more than 40 countries all around the world. And here again, Biogen is investing in life cycle management, as outlined here on the slide, very important ability to compete, ability to launch. Biogen is also demonstrating the ability to create headroom for neuro innovation with the biosimilars that we commercialize in Europe, the 3 anti-TNFs, but also generated revenue and growth for the organization. This is critical for the sustainability of the system. The payers cannot pay everything for everybody for all the time. We need to generate savings with biosimilars. And we all know that the opportunity in this country is tremendous, yet to come because not yet realized. We have enlarged our partnership with Bioepis now with 2 more compounds in ophtha and larger geographies. And we have 3 anti-TNFs for the important country of China. So we are committed also in terms of value proposition when we engage with payers to create headroom for our neuro innovation. It makes Biogen stronger in each one of the market where we operate. Biogen has also demonstrated the opportunity to grow in the U.S., to grow in mature market ex U.S. but grow faster in emerging economies, while establishing new entities in the countries that you see here listed. This was also driven by the launch of SPINRAZA and biosimilars. But now we have an operation that is stronger, ability to compete, ability to launch, creating headroom for neuro innovation and an organization able to execute and implement in a larger geography. We just need to fuel this capability with more product. And again, the inflection points with all the readouts is coming up, and the organization is ready. This speaks for itself. Thanks to the flawless implementation and the capability of the team. This is the strong financial track record of Biogen. Earnings leveraged. Cash flow generation, $7 billion-plus during the last 12 months. Diversification in terms of portfolio from a company that was almost solely with 1 strong pillar in MS now having different legs, if I may, in terms of revenue generating. We are proud about this momentum, and we are committed to continue on this path. So now the key question is, is Biogen able to sustain or accelerate on this momentum? Do we have the momentum? Even if you look at the past 3 months, the launch of VUMERITY, the results on BDCA2 and then large negotiation with biosimilars, the decision to file aducanumab in the U.S. and to engage with other regulatory authorities, momentum is there for long-term value generation for patients and shareholders. Let's go back one second to the strategy, 2 main pillars. The first one, flawless execution on the current core, maximizing the resilience on MS. I think it is demonstrated. Accelerating the neuromuscular franchise and reaching SPINRAZA with eventually the SOD1 product in ALS, and therefore, building a franchise. Unlocking the potential of biosimilars, we are absolutely working on that. The second pillar with the new box on the top is leading in Alzheimer's disease. This is our priority. This is -- this has made the highlight for the company and, I will say, within the circle in which we all work because the unmet medical need, the value creation opportunity for the patient and for the shareholders is tremendous. And we want this to be sustained over a long period. Obviously, developing and expanding the neuroscience portfolio. And last but not least, the very important capital allocation since we generate a substantial cash flow. So this is where we are, in front of near-term value creation opportunities that are almost unprecedented in the field of Alzheimer's disease first but also neuromuscular with ALS, stroke, lupus and ophthalmology for this company that came from almost a space with a 1 franchise that we did defend well, for which we did compete and we continue to compete. SMA, launched extremely well; biosimilars that did not affect the rest of the business. Now the organization is ready in order to launch new solutions for patients. So as an illustration here, the capital allocation opportunity, we have approximately nowadays $6 billion of cash. If there were to be leveraged, this could give a $16 billion financing opportunity. And for illustration, if we were to maintain the similar level of cash flow generation over the next 5 years, the capacity will be pretty, pretty large. That -- this will give us plenty of opportunity to fuel the business but also return to the money capital to the shareholders based on the best value opportunity and return and also operate some BD. We have done 15 deals in the past 3 years, and we will continue to look at opportunities. I stand here before you, very strong on and proud on the purpose of our company for patients first and this space that is tremendous where unmet medical need is just, just, I will say, terrible. And our mission is to deliver the best for those patients and think about what this company has done for the MS and SMA patients with the first hop, and we have to continue. So there is -- there are some risks, but the rewards are tremendous. And now I believe that we are closer than ever. I'm very proud with the employee base and what we do for inclusion and diversity. I'm also very proud to -- for Biogen to be the #1 biotech company on the Dow Jones Sustainability Index and the day-to-day engagement of our company with the community. The purpose is strong. We can stand strong every morning when we go to work on what we deliver for society, for the community, for the employees, for the shareholders, for the patients first. The near-term opportunities in terms of epidemiology-based on these inflection points and the readouts speaks for itself, 50 million patients with dementia, ALS with no treatment, lupus with some cases of mortality, with stroke for which there was not clear innovation since decades except some intra-arterial interventions. We have 2 programs. We are very proud about those 2. And last but not least, ophthalmology that is also affected by genetics sometimes but a lot by the aging of society. And I believe that Biogen can meet those opportunities with aducanumab first filing decision, with the 11 readouts that we'll have in the next 18 months, with the capital that we have available in order to do even more, and last but not least, with diligent execution. The time for neuroscience is now, and the time for Biogen is also now. Thank you.

All right. We've got green light. So this is the Biogen breakout session. Michel, you want to introduce your colleagues up here with you, we can get started with Q&A.

Al Sandrock, Head of Research and Development; Jeff Capello, CFO. So good afternoon, everyone, and we can get started.

So feel free to either to raise your hand for questions or just speak out if you have any. But to kind of kick things off, maybe you could speak to the gating factors that are still left to submit the BLA for aducanumab.

I guess I'll take that. This is Al Sandrock. So we are -- we've been constructively engaged with FDA basically since last June and when we had our first Type C meeting, and we continue to be engaged with them. And it's a matter of submit -- preparing all the different modules of the common technical document and submitting them to FDA as rapidly as possible.

So engagement is going well. And beyond the U.S. FDA, we are also engaging with other regulators in Europe, in Japan and soon beyond those.

And how is the feedback compared from other regulators relative to the FDA in terms of what they want, whether you file now or if they want to see additional [indiscernible].

I think it's too early to comment on that. Positive discussions, though.

Okay. And then Al, can you maybe speak to the feedback you've been getting from the medical community since you had a more detailed presentation of data at CTAD last month?

Well, I think the comments of the panelists, Dr. Cohen and so forth, Ron Petersen and others are very similar to what I've been hearing. I think the field has been waiting for a long time for a drug that may work in this disease. I think the -- certainly, the EMERGE data set. We believe it stands on its own as a positive study. The -- Dr. Cohen noted that the effect on activities of daily living were very important to her because these activities obviously determine whether or not somebody can stay out of the nursing home. And that they find -- I think the people I talked to also find that the engaged data that the post-PV4 data set that we showed did provide supportive evidence. And then people are also reminding me of the PRIME study, the Phase Ib study that we published that also showed a dose-dependent effect. So that's what I'm hearing, basically.

Okay. And then I'll say upfront it's probably not a very fair question or makes you speculate somewhat. But if you were to fast forward to this time next year, what do you believe would be the key reasons why aducanumab was approved? Or why it wasn't. And those are the biggest pros and cons that are out there.

Well, I think we have a good chance of looking back and saying that it was approved, although we don't know until the final decision is made, I think. And if we were to look at why, I would say, in addition to the EMERGE, ENGAGE and PRIME data set that I just talked about, I think FDA has to weigh the fact that this is a very serious disease. It's fatal. And it's terribly disabling. There are no alternative treatments. They'll look at the safety associated with the drug. They'll look to see whether or not there's a mechanistic, that we understand the mechanism of action of the drug, and does it make sense in the context of the pathophysiology of the disease. They'll look at effects, for example, like on the tau biomarkers we showed at CTAD, which I think will also help. And they'll see whether other drugs like it, for example, BAN2401, the close -- the most similar antibody to aducanumab. Does that provide any supportive evidence as well? So I think they'll look at the totality of the -- of all that and make a very -- it's going to be a difficult decision for them, right? I mean it always is, it seems, but I think they'll make the right decision for patients.

And these are very good points. At the same time, we want to be very respectful of the criteria the U.S. FDA will take into consideration. The integrity of the process is paramount. So at this stage, we need to step back and let the regulator do his job.

So I mean Al, when you speak to your colleagues, Michel made a pretty compelling point when you started your presentation, the next 25 minutes, 25 people are going to be diagnosed with Alzheimer's. How much Alzheimer's research in the near-term is riding on this review? And kind of how the FDA deals you, deals with the program?

Well, I think when you look at, for example, multiple sclerosis. When the first disease-modifying therapies were approved, it led to a lot of excitement in the field. A lot of companies invested in R&D for MS. And now we have more than a dozen products approved sort of 20 years later. I'm hopeful that this will trigger investment by the academic and industrial community to invest in Alzheimer's because it is tractable. I believe it is tractable. Up until now, I think a lot of people thought it was intractable.

Okay. And then can you put safety into context? There's a lot of talk on ARIA and the rates of it. And how worrisome is this side effect for an Alzheimer's patient and the downstream consequences potentially getting it?

Well, the summary of ARIA that we stated at CTAD is that it does occur at the incidences that you described. It is dose and carrier status APOE carrier dependent. Most of the time, it's asymptomatic. When the symptoms do occur, they're generally mild, and the most common symptom is headache, and the second most common is confusion. I would say that over the past decade or so since the first days when ARIA was seen with bapineuzumab, the community -- the physicians have figured out how to manage it, how to deal with it. And even in the setting of the aducanumab Phase III trials, we had 2 protocol amendments that allowed for higher dosing and for patients to return to the higher dose if they had ARIA because the safety monitoring committee got comfort around ARIA and its management, even within those 2 studies. So I think the -- when I -- the summary is that over the past 10-plus years, we've -- we learned a lot about ARIA. I think there's a certain degree of comfort on that we could manage it. But we should -- but I'd be loath to understate the importance of making sure that our drugs are safe for patients and to monitor them accordingly.

Okay. And is it your expectation -- I assume it would be that you get priority review on this application, or how much does the complexity of the data set potentially play into that?

Well, I would say that that we're in a very unique situation. I've never been in one quite like this. I mean to go from futility to a filing is a unique in and of itself. And I would say that the level of constructive engagement we've had essentially since the first Type C meeting in June is pretty unusual and a high degree of engagement. So I would leave it at that.

Okay. And then putting the cart before the horse here, but if you were to go down this road and you are ultimately approved, how would you kind of put into context your -- or put into a framework how you think about pricing something like this, and knowing how many patients would want a product that has a modifying type of effect?

So we are very early in the process. We start engaging with the different stakeholders, pharmacoeconomists, thought leaders and customers in order to start to prepare our best understanding. I will say the most important is that the patients get access to the product. It has been such a journey not solely for Biogen, for all the pharma biotech community and academic community, they're working on this terrible space. And so medicines are for the patients. And one should not take advantage of the situation of being on the market. So for me, success will be that patient can access the product. And unfortunately, or fortunately, it's not suddenly the medicine that will be the -- what will set the criteria for success. It's diagnosis. There is a clear bottleneck in terms of diagnosis capacity. Just imagine, if a company gets the opportunity to get a product approved, population is informed, caregivers are informed and diagnostic capacity is not yet there. So I think there is a lot of improvement. And on -- from the side of policy leaders, there is the [ 1S ]. Some people are talking about the companion diagnostic type of mindset and plenty of companies. I believe there will be a transformation of the diagnostic industry with all the genetically validated compounds being developed nowadays from all the companies, including for AD. And so basically, this is the way -- in some countries, it's number of specialists that is a bottleneck. But again, on price, [free consensus]. At the end of the day, what matters is reaching the patients even if we have to disrupt from the old models of a fee-for-service in a country. But for that, we're engaging with authorities and payers, and we'll see.

If the U.S. government should implement any of the international price indices that have been proposed, how do you see that impacting Biogen's U.S. pricing? And is it important? And are the 40 countries in which you have indicated that you have early access programs going to have any impact on U.S. pricing?

If you look at the history for the industry, there are some obvious gaps between U.S., ex U.S., even though we need to be careful between the gross and the net prices and what we compare. If we compare apples-to-apples, is it a Medicaid with the type of a system that we can compare with the public European system where everything is paid by the state? Or is it a private market? So there are many conflicting criteria here that makes the picture, unfortunately, not clear. I think that the industry has the responsibility to make it more clear, but we're not the only one. We are trying. The rebates debate is very important in the U.S. Unfortunately, it's not making much progress because the industry is giving out tremendous rebates that do not fall to the patient's benefit but towards other places. So it's a very complex situation. Moving forward, what I see is that companies will be much more careful, first of all, at taking price. This is my view. And it's a case of Biogen, we are very careful and CPI for the products where we don't invest in R&D, and a bit more when we do invest for innovation. So this is certainly an important self-discipline that each company needs to put in place for themselves first. But we need also the support of policy leaders to secure that whatever we give out goes to the patients. The affordability problem is even more acute than the price one, the affordability for the patients.

So aside from pricing, what other groundwork are you laying at this point to prepare for a potential aducanumab launch?

So we start to build the team in the U.S. and ex U.S. in terms of medical affairs, so that we can start engaging with the scientific committees a bit more comprehensively. Obviously, 2 years ago, we started some pilots because even in an U.S. market, the market -- there are different markets in the U.S. And we try to understand what was the patient journey in terms of origination, diagnosis and referral. Unfortunately, there is no treatment. And it's pretty complex. And it takes a lot of time actually. And it's different from a patient within Kaiser versus a commercial patient versus a Medicaid patient. We have our go-to-market model in the U.S. This was approved by the CFO of the company in December, and we start building the team in the U.S. gradually. We hire the top talent. We promote and place some of the best talent of Biogen into that space, and we get ready.

I would just add from a manufacturing facility perspective, the company made a decision a number of years ago to start a state-of-the-art manufacturing facility in Switzerland. And that's slated to come online at the end of this year. And that facility will produce aducanumab, and it will have, once it's fully operational, pretty much unlimited capacity. So we're very well positioned from a manufacturing perspective.

But importantly, our manufacturing center in North Carolina will also produce aducanumab and will be the first center ready in the U.S., for the U.S. and hopefully, for the rest of the world.

And, Al, what does a resurrection of aducanumab potentially mean for BAN2401. Do you -- does the lack of titration with that product make you any more confident in that asset relative to aducanumab?

Well, it's wonderful to have a partnership with Eisai and have 2 treatment options for Alzheimer's. As a physician, I always liked having more than 1 treatment option. And yes, I mean there are very similar binding characteristics, and in many ways, similarity in terms of robust dose-dependent amyloid reduction. And in the Phase II trial with BAN2401, you saw efficacy at the highest dose, 10 milligrams per kilogram biweekly. So yes, and so we'll consider all those aspects. And the ARIA incidence does seem to be a little bit less. Although you have to take out the compounding effects of carrier status to look at that, but it does look a little less and without titration. So it provides additional options for us.

Okay. And then breakthrough designation for aducanumab. Status there.

Well, we haven't announced anything about that, but I would reemphasize the fact that we have had very active and constructive engagement with FDA all along since June. So functionally, we have all the engagement we would ever want.

Okay. All right. So we're down to less than 9 minutes. I want to make sure we get some other topics in -- sorry, I guess not. No, go ahead. Go ahead.

Al, the FDA allowed you to redose patients [indiscernible]. Can you give an update as to where that program is today? And is it only -- will it be newly screened patients also that you will redose, or just participants in the trial?

So for people on the line, it's -- the question was about the redosing study. And we will start redosing imminently. We do have -- the sites will start coming online we predict next month, February, and we'll dose the first patient soon after the sites come up. And in terms of the people included in the redosing study, it will only be people who had been previously treated with aducanumab or were on placebo, but only patients who are in our clinical trials of aducanumab.

All right. So then to transition to a couple of other topics before time's up. On TECFIDERA, I know this is usually a tough question to answer, but can you frame scenarios around the upcoming IPR? And is this settlement still something that's possible once the oral hearing had already been taken care of back in November?

So the question is around tech IP. We have the patent that goes out until 2028, but that's been challenged, both in the patent office and in a couple of district court cases. I think the first thing to understand is we feel we have a pretty strong patent position. It's been challenged before, and we've been successful. That's the first thing to understand. With regard to timing, the IPR will read out sometime in the first week of February, that's the expectation of that, and then the 2 court cases probably mid-2020. So we'll have to see how we fare. We have settled some of the cases, which is good news. In the event that we're not successful and one of those 3 the patent does not survive, typically, there's a 12- to 18-month appeal process. So we'll avail ourselves of that. And then in the case that we continue to not be successful, we'll leverage our franchise. We have a new product VUMERITY, which is a new novel fumarate that's been launched here 3 weeks ago. So we think that has a lot of promise. So that's an opportunity. We've done a number of things around life cycle management, extended interval dosing in TYSABRI, pregnancy for interferons and intermuscular. We'll leverage the rest of the franchise, the SMA franchise. Biosimilars, we did a new deal. And then we've got 11 important readouts in the next 24 to 48 months, of which 5 alone could be multibillion-dollar opportunity. So we've done a lot of good things on the pipeline. We're going to leverage that as we move forward.

And you mentioned VUMERITY. Can you talk about that early launch and the type of reception you're getting from the -- for the product?

The reception is positive. It's the first weeks. This can be very material over time. It's an alternative for specific patients. The team is well engaged. We are using opportunities to make sure that they go for it. There is 1 opportunity to launch well. But it's still the first few weeks, so it's too early in order to assess success. We have first signals in terms of encouragement from the prescriber base and from source of business that come basically from 2 sources, TECFIDERA, but could have been already patients switched to other therapies or other therapies from the outset. But it's too early in order to quantify that because the sample is still too small. So we'll come back, and we'll update you when we have opportunities during earnings and other conferences. But the team is there, well-trained and well engaging with the customer base. And remember, there are significant number of prescribers that are high on orals, but low on TECFIDERA. So there is really an opportunity to go for it. The team is motivated.

For SMA, I wanted to ask about the evolving competitive landscape here. Obviously, you have gene therapy in the market. Now you have the potential for an oral compound to enter the market a little bit later this year. And what are the latest thoughts on SPINRAZA's outlook given the competitive dynamics?

So if I may start. Al will give more details scientifically. SPINRAZA is doing well. And I had the opportunity to meet with the scientific leader a couple of days ago. The patients are continuously improving this positive feedback in terms of benefits that they see over the long term having the product. So this is really great. And obviously, now for the newborn, and newborn screening is being implemented in some states in the U.S., and we are thankfully able to detect patients at the first days. So then the parents here have the opportunity eventually to go for gene therapy. Some do. Some do. And it happens that in some cases, after the gene therapy dosing, eventually, they want additional efficacy or -- and they come and take on SPINRAZA. So we know that also for all the patients, and the file is under review by the -- on clinical hold by the FDA. So this is being delayed. And then there is the other alternative [ resi ] plan from Roche, for which we expect data at any time.

Yes, I don't have too much to add. I mean the intrathecal Zolgensma is on hold. We don't know what the content of their interactions with FDA have been and may be related to the article published a little while ago by Jim Wilson and colleagues that you can get dorsal root ganglion neuropathy with SMA gene therapy. In terms of Risdiplam, we don't have much data yet that we've seen. And we don't have the label obviously, so we'll have to look at the efficacy and safety.

Important to consider that beyond the U.S. and large mature markets, the product is basically launching in emerging -- large emerging markets. So there is this dual dynamic where there, the mature market where the penetration is pretty good. And then there are the launch countries where it's just the first days.

And on the strategic front, Michel, in your presentation, you talked about having $51 billion in potential buying capacity through 2024. Does that assume the launch of aducanumab by, let's say, early 2021? Is that built into the forecast that gets you those types of numbers through '24?

So this was an illustration based on the last 12 months cash flow generation. If there were to be kept at the same level for the next 5 years, this will be.

Okay. So the last 12 months. And then can you talk about your appetite for M&A? And assuming that there is a desire there, what's the ideal fit for Biogen at this point in terms of either size, maturity, things like that?

I just would like to say that the Biogen team is continuously screening opportunities early mid-size, a bit larger size and independently from any other events. We look at what could add most value to the shareholders and in terms of capital allocation.

Yes. And I would just say we've been very active. In the last 3 years alone, we bought 15 different companies or assets. We spent $3.5 billion. At the same time, we bought back over $10 billion worth of stock. So as Michel had said, $7 billion of free cash flow in the last 12 months alone. $50 billion of capacity if that continues. Well, obviously with the aducanumab, if that's successful, that could go north of that. So that's very healthy. But we also have $8.3 billion of share repurchase authorization available to us. So I would expect us to be very active from a BD perspective and a share repurchase perspective, particularly with the stock price at this level.

But most of the BD that we have done were early stage. Because we believe this is a sweet spot, this is where we can add most value based on the specialization of the organization. What I'm pleased about is when I see the portfolio maturing. We didn't make any shortcut to buy revenue or to go rapidly to a larger size. We tightened the belt. We executed well, and you've seen the data. And here we are with an inflection point with 5 or 6 new opportunities, 11 mid- to late-stage readouts in the next 18 months and the decision to file aducanumab.

Okay. Time is up, so we'll end it there. Thank you guys very much.

Thank you.