Good morning. My name is Katie 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 2023 Earnings Call and Business Update. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. Today's conference is being recorded. Thank you. I would now like to turn the conference over to Mr. Chuck Triano, Head of Investor Relations. Mr. Triano, you may begin your conference.

Thank you, Katie. Good morning and welcome to Biogen's fourth quarter and full-year 2023 earnings call. Before we begin, I'll remind you that the earnings release and related financial tables including our GAAP financial measures and a reconciliation of the GAAP to non-GAAP financial measures that we will discuss today are located in the Investors section of biogen.com. Our GAAP financials are provided in tables 1 and 2, and table 4 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 have also posted the slides on our website that will be used during this call. I would like to point out also 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. On today's call, I'm joined by our President and Chief Executive Officer, Chris Viehbacher; Dr. Priya Singhal, Head of Development; and our CFO, Mike McDonnell. Chris, Priya, and Mike will each make some opening comments and then we'll move to the Q&A session. To allow us to get through as many questions as possible, we ask that you limit yourself to one question. With that, I’ll now turn the call over to Chris.

Thank you, Chuck. Good morning, everybody. A year ago, I had the opportunity of presenting Biogen's quarterly results for the first time. At that time, we expressed the objective of returning Biogen to sustainable growth. I think in the intervening year we've made substantial progress, and today it is with a great amount of pride and pleasure that we can announce earnings guidance, which Mike will go into in greater detail, indicating that we expect to see positive earnings per share growth. As I've mentioned on a number of occasions, once we can get Biogen growing, we really see it becoming a growth company for the foreseeable future. We have very little, if any, exposure to the Inflation Reduction Act with our current portfolio. There are no new patent expiries coming in anytime soon other than those that are already known. We've undertaken a number of other measures that have really repositioned Biogen for growth. Let me review some of those things. First is the refocus of the company on growth drivers, particularly our new product launches. Biogen had four new product launches from approvals from the FDA last year, which is the second highest in our industry. This required a significant cultural change. The multiple sclerosis franchise has been the stalwart of our company for 45 years. Our people are passionate about treating multiple sclerosis and the patients affected by it. We continue to be a market leader, but we face increasing competition and we need to embrace new therapeutic categories and new businesses. Therefore, we've made a major shift in resources and focus, particularly towards LEQEMBI, ZURZUVAE, SKYCLARYS, and QALSODY. We still have some products with patent protection, again with substantial competition. For example, analyst forecasts indicated that SPINRAZA would decline. However, I am particularly proud of our teams for demonstrating that they could bring this product back to even modest growth. The route of administration can be a competitive advantage. For example, if you have a pill, it's going to be more preferred than an infusion. However, we see that in some of these devastating diseases, efficacy is the most important factor, and that is why SPINRAZA continues to lead in its segment. Biogen excels at developing the medical evidence to support the value proposition of its products. As many of you told me when I first came into the company, we have a mature product portfolio, but one of the highest cost bases in our industry. We took steps to address that. It wasn't just about reducing costs; we wanted to reengineer the business. We shifted our focus, entered new therapeutic categories, and needed to think about capabilities, the agility of the organization, and the management layers. We implemented a fit-for-growth reengineering project and so far, we've achieved $200 million in savings, and we're on track to realize approximately half of the $800 million in net savings by the end of 2024, which would be a gross savings of $1 billion. We had to review our research and development as Biogen targets devastating diseases with many where no one else is focusing. However, it involves a lot of risks, and clinical trials can be expensive. We need to manage the risk in the portfolio and make Biogen a sustainably growing company, attractive to investors. We've been extremely disciplined and objective in reviewing our pipeline, with four data readouts expected this year on critical illnesses, and Priya will discuss that further. Research and development is extremely important to us and will continue to be a source of growth for the future. As we look at what drives growth, clearly, we have LEQEMBI. This product's pioneering not only in science but also in commercial aspects. One interesting point with this disease is that the efficacy does not solely depend on the product but also on whether we are targeting the correct patients. Historically, the industry has invested in drugs that failed in Alzheimer’s disease due to inadequate drug delivery across the blood-brain barrier and incorrect patient targeting. Clarity was the first study to convincingly demonstrate the efficacy of plaque reduction on cognition. Some data we presented at CTAD indicates that the sooner we start treatment, the more likely it is to show greater efficacy. We’re investing significantly in the AHEAD study focusing on pre-symptomatic patients. We're also working on making administration more convenient through a subcutaneous formulation. Our launch in Japan has been successful, and we're seeing an uptick in patient numbers in treatment. We believe we have validated our go-to-market model and anticipate an increase in promotion as our reimbursement and care pathways are solidified. We are making strong progress with LEQEMBI, and we believe it holds significant long-term importance for both patients and our financial outcomes. Moving on to SKYCLARYS, we've achieved about 1,000 patients on therapy, despite not having a pediatric indication yet. The Earth of potential population is about 4,500, giving us over 20% of the patients in therapy within approximately six months of launch. Many complexities arise from launching in rare diseases, but Biogen has demonstrated strength by reducing the time from start form to shipment by 45%. We're working on reimbursement coverage and have established patient services to assist patients and physicians. For SPINRAZA, we see a significant international split in revenue, with two-thirds generated outside the U.S., a model we expect for SKYCLARYS. Last night, we announced formal approval for SKYCLARYS by the European Commission, and we continue expanding access across Europe. Additionally, ZURZUVAE addresses a significant unmet need in maternal and mental health. The launch indications are promising, though it's still early to conclude, but trends are quite positive. I'll now pass it over to Priya to discuss the promising developments from our pipeline.

Thank you, Chris. As we previously discussed, we have focused on reviewing and prioritizing our development pipeline with a keen eye towards maximizing probability of success and increasing potential return on investment, as Chris noted. The intention was always to focus our pipeline to better represent a risk-reward balance, one that we believe could help Biogen achieve sustainable growth. While this effort resulted in several program discontinuations last year, specifically in areas we perceived significant regulatory development and commercialization challenges, we also highlighted areas where we had deep expertise and promising pipeline programs that warranted an invest-to-win approach. One such area is Alzheimer's disease where we have an industry-leading pipeline, and we do expect to continue investing to expand our leadership. This starts first by building upon our opportunity with LEQEMBI. Our priority is to work closely with Eisai to ensure LEQEMBI is available globally to patients suffering from early Alzheimer’s disease. With approvals now obtained in the U.S., Japan, and China, and filings currently under review in 14 additional markets, we believe we are well on our way to achieving this goal. Secondly is creating additional treatment options for patients. Data presented at CTAD last year on LEQEMBI indicates that there is continued benefit associated with treatment out to 24 months, and that treatment earlier in the disease course had a greater effect on clinical outcomes. For this reason, we are collaborating with Eisai to submit a filing for maintenance dosing with IV LEQEMBI, as well as evaluating LEQEMBI's administration in preclinical Alzheimer's disease in the AHEAD 3-45 trial, which evaluates patients before the onset of symptoms. Eisai also aims to submit a filing for a subcutaneous version of LEQEMBI by the end of March. Beyond LEQEMBI, Biogen is advancing pipeline programs targeting tau. We believe tau represents the next frontier in Alzheimer's therapeutics, and we are also supporting the development of diagnostic tests and pathways. Our ASO targeting tau, BIIB080, represents a novel mechanism for targeting tau distinct from prior antibody attempts. In the Phase 1b study, we saw a convergence of target engagement, reduction in tau pathology in the brain, and improvement in exploratory measures of clinical outcomes. We are very encouraged by these results and are currently evaluating BIIB080 in the Phase 2 CELIA study. We also have BIIB113, a Phase 1 small molecule aimed at reducing tau aggregation. Importantly, our research organization is focusing on the future of Alzheimer's treatments, pursuing a multimodality approach to evaluate other potential targets implicated in Alzheimer’s disease biology. Looking beyond Alzheimer's disease, Biogen has an opportunity to expand our growing rare disease portfolio. Rare disease expertise is a core competency at Biogen. I will address BIIB121 in Angelman's syndrome. This is a rare genetic neurodevelopmental disorder occurring in approximately one in 15,000 live births worldwide. It is diagnosed in early childhood and characterized by symptoms such as severe developmental delays, speech impairment, and problems with movement and balance, as well as potential seizures. While there is no specific treatment approved, affected individuals typically require continuous care and cannot live independently. BIIB121 aims to remove the silencing of the paternal allele to restore UBE3A gene expression. The HALOS 1 study is designed as an open-label, multiple ascending dose study across age groups and dose levels to assess safety and tolerability while utilizing clinical measures to evaluate therapeutic potential. This includes objective EEG assessment and clinical evaluations across multiple domains of Angelman's syndrome. The HALOS study has completed enrollment for its multiple ascending dose portion, and interim results presented by Ionis have been encouraging. Overall, we are optimistic about these early trends and anticipate a comprehensive topline study readout expected mid-year. This data will allow Biogen to decide whether to conduct a pivotal study. Moving to lupus, this is another area with significant unmet medical need. We currently have two Phase 3 assets in Systemic Lupus Erythematosus: first, dapirolizumab pegol developed in collaboration with UCB, and we expect a topline readout of the Phase 3 study in mid-2024. Secondly, litifilimab, our anti-BDCA2 antibody developed in-house is currently undergoing two Phase 3 studies of SLE. These studies are enrolling and employ a 52-week primary endpoint. Importantly, litifilimab could be a first-in-class biologic in Cutaneous Lupus Erythematosus, which is associated with severe scarring and dyspigmentation, distinct from SLE. While we focus on reviewing our pipeline to identify and prioritize areas with both expertise and confidence to deliver meaningful new treatments for patients, this process remains dynamic. We are committed to efficiently seeking out scientific insights and continuing to build a pipeline reflecting the right risk-reward balance. We look forward to four key near-term readouts this year and continue to focus on identifying additional opportunities beyond neuroscience. Thank you, and I will now pass the call over to Mike.

Thank you, Priya. Good morning, everyone. I'm going to provide some highlights and color regarding our financial performance for the fourth quarter of 2023, followed by details on our 2024 financial guidance assumptions. Please note that all financial comparisons are versus the fourth quarter of 2022. Total revenue for the fourth quarter of 2023 was $2.4 billion, a decrease of 6% at actual currency and 5% at constant currency. Non-GAAP diluted earnings per share in the fourth quarter was $2.95, including a $0.35 negative impact from the recently disclosed closeout costs related to ADUHELM. For the full year of 2023, total revenue of $9.8 billion represents a decline of 3% at actual currency and 1% at constant currency, consistent with our recent guidance of a low single-digit decline. Full-year 2023 non-GAAP diluted EPS was $14.72, aligning with our guidance range of $14.50 to $15. Total MS product revenue was $1.2 billion in the fourth quarter, down 8% at actual currency and 6% at constant currency due to competition from generic TECFIDERA. Notable updates regarding our MS business include the European Commission revoking the centralized marketing authorization for generic versions of TECFIDERA. Consequently, Biogen is entitled to marketing protection for TECFIDERA until February 2025. Similarly, a TYSABRI biosimilar has launched in a few European countries. We expect additional biosimilar launches in the first half of 2024, both in Europe and the U.S. VUMERITY has experienced modest growth in 2023, though pricing pressure and an overall contraction in the U.S. oral segment are expected to continue in 2024. Regarding our rare disease portfolio, including SPINRAZA, SKYCLARYS, and QALSODY, we reported revenue of $472 million in the fourth quarter, up 3% at actual currency and 6% at constant currency. SPINRAZA outside the U.S. benefited from timing of shipments but was impacted by pricing pressure and competition in Europe. We believe we can return SPINRAZA to growth over time as the market leader in SMA. SKYCLARYS generated $56 million in its first full quarter as a Biogen product, and we are pleased with continued patient growth. Biosimilars generated fourth-quarter revenue of $188 million, increasing 8% at actual currency and 10% at constant currency. We continue to explore strategic alternatives for this business while ensuring we maximize shareholder value. Our anti-CD20 revenue totaled $436 million, which included a $12 million operating loss from LUNSUMIO. Contract manufacturing, royalty, and other revenue of $118 million in the fourth quarter was notably lower year-over-year, influenced by batch timing. Moving to expenses, fourth-quarter non-GAAP cost of sales was 25% of total revenue, including $52 million in idle capacity charges. Non-GAAP R&D expense decreased $34 million, including approximately $45 million for the LEQEMBI collaboration and approximately $60 million for ADUHELM closeout costs. Non-GAAP SG&A expense decreased $44 million driven by around $110 million in cost savings initiatives. Our balance sheet ended the year with $1 billion in cash and marketable securities and $6.9 billion in debt, resulting in a net debt position of $5.9 billion. In the fourth quarter, we utilized approximately $1.3 billion in cash for final acquisition payment obligations related to the Reata transaction. Additionally, we paid down roughly $350 million of the $1 billion term loan established at the acquisition time. It's essential to note that $393 million of the $1.3 billion was reflected in cash flow from operations for a one-time payment related to equity-based compensation for the Reata transaction. Without this, full-year 2023 free cash flow of $1.3 billion would have been approximately $1.7 billion. We expect to generate strong cash flow this year and foresee a payment of $437 million from Samsung in early Q2. Now, regarding our full-year 2024 guidance ranges and assumptions, we expect non-GAAP diluted earnings per share to be between $15 and $16, reflecting growth of about 5% at the midpoint compared to 2023. Total revenue is anticipated to decline by low to mid-single digits, but we expect core pharmaceutical revenue or product revenue plus Biogen's 50% share of LEQEMBI revenue net of sales and royalties to be relatively flat for 2024. This assumption arises from the expected revenue growth from new product launches, roughly offsetting declines in MS product revenue. We expect contract manufacturing revenue to drop significantly throughout 2024, partly due to completing specific batch commitments from 2023. Improvement in revenue from new product launches, the decrease in contract manufacturing revenue, along with lower idle capacity charges, are expected to favorably influence cost of sales as a percentage of revenue for 2024. Operating income is anticipated to grow at a low-double-digit percentage, with operating margins increasing in the mid-single-digit percentages compared to 2023. We project our combined R&D and SG&A spend to total around $4.3 billion in full-year 2024. Additionally, we expect the other income and expense line to remain a headwind this year due to decreased interest income and heightened interest expenses following the Reata acquisition. In summary, we expect improving revenue profiles, enhanced margins, and a return to non-GAAP EPS growth in 2024. Our primary goal remains the return to sustainable growth while creating long-term value for our shareholders. Now back to Chris for closing remarks.

Thanks, Mike. We have several milestones this year that we'll be monitoring closely. We have a scientific advisory group for LEQEMBI in the first quarter, and assuming a positive outcome from the CHMP, we hope to see approval by the European Commission later in the first half of this year. SKYCLARYS has recently received European approval, and we expect a decision for QALSODY by the CHMP and the European Commission in the same timeframe. We have regulatory submissions upcoming for the subcutaneous formulation for LEQEMBI and IV maintenance dosing. As Priya mentioned, we anticipate four important data readouts mid-year across four programs. As I said earlier, I believe we will focus more on our pipeline and its expansion this year. Chuck, I turn it back to you and we can open for questions.

Thanks, Chris. Katie, could you please open the polling for questions? Thank you.

Thank you. Our first question comes from Marc Goodman with Leerink Partners.

Yes. Good morning. Can you walk us through just the subcutaneous and maintenance approvals? Obviously, timelines, I guess, would be around the end of the year, but just talk about the impact on the market. Let's assume Lilly's on the market as well with a similar approach. How do you expect this to change the dynamics and uptake? And just give us a sense of that, please. And then also, maybe you could just talk about the uptake in Japan that you expect? Thanks.

Yes. Thanks, Marc. Priya, do you want to start with timelines? I can address the commercial aspects.

Sure. Thanks, Marc, for that question. Overall, we shared our six-month data for the subcutaneous formulation at CTAD last year. We believe we have achieved bioequivalence with the IV formulation. Eisai has communicated their recent updates about the upcoming FDA meeting to finalize strategy for submission. The aim is still to file by the end of March 2024 for the subcutaneous formulation. Additionally, there is data regarding the potential and need for IV maintenance, and that is also targeted for filing in Q1 2024. That’s the plan currently. I'll turn it over to Chris for the commercial dynamics.

Yes, so, Marc, the primary benefit of the subcutaneous formulation will be convenience for patients. As mentioned earlier, we're also focusing on the AHEAD study for potentially acquiring an indication for much earlier-stage patients. The maintenance approach will ensure that patients can continue treatment if we gain approval, further preventing plaque recurrence, meaning the time with the drug will expand as we conduct these studies. In terms of the competition with donanemab, physicians are sensitive to ARIA risks and safety; we have a significantly safer profile with LEQEMBI. The study for donanemab followed a different trial methodology where the stopping criteria were not known; this uncertainty could complicate its market entry. We will strategize around the information we get from all these studies, and while we see donanemab entering the market before our subcutaneous formulation, we are confident in LEQEMBI’s position.

Do you want to comment on Japan?

Regarding Japan, Eisai is allocating its entire field force to support this launch. Given Japan's government-managed healthcare system, the complexities we face in the U.S. may be reduced. While access to neurologists, PET scans, and other diagnostic requirements may present some challenges, we expect a faster uptake in Japan than we saw in the U.S. due to the current healthcare system. According to feedback from the field, there has been a positive reception among physicians.

Great. Thanks, Chris. Next question, please, operator.

Good morning. Thanks for taking my question. I have one regarding the bottlenecks on the LEQEMBI launch. Could you speak to two aspects? One is your expectations for Medicare Advantage matching the coverage levels of traditional Medicare, and over what timeframe? Secondly, just an update on patient access to neurologists. Thank you.

Yes, I haven't heard anything suggesting Medicare Advantage would be different from traditional Medicare. I'll need to confirm that, but I believe it is consistent. Discussing bottlenecks, evidence from patient registries indicates that we have nearly twice the people registered versus those on treatment; therefore, in addition to the bottleneck caused by access to neurologists, there's a constraint in scheduling MRIs, an essential prerequisite before initiating infusions. These MRIs have specific scheduling requirements, limiting efficiency. While MRI availability is ample, the precise scheduling process creates a bottleneck, as we cannot have an infusion without scheduling the MRI first. The complexity of coordinating these steps is a challenge that will take some time to ease as stakeholders get accustomed to this process.

Great. Thank you, Chris. Let's proceed to the next question.

Hi, guys. Thanks for taking my question. I wanted to inquire about the CD40 Phase 3 study in lupus. Could you talk about the reasons for the trial size reduction from 450 down to 320? What challenges are you facing, and how does that impact your confidence in efficacy? Also, what is the alignment with regulators regarding the primary endpoint and the preferred index for efficacy evaluation?

Thank you, Umer. We expect our results from the first Phase 3 mid-2024 and anticipate requiring a second Phase 3, pending positive results, to support regulatory filing. The protocol amendment regarding the trial size reflects discussions with Biogen and UCB, where we sought to balance proper study design with a desire to expedite dapirolizumab's delivery to patients in need. We believe the trial is appropriately powered and continue coordinating regulatory interactions to support the next steps. Hence, it is positioned to deliver a clear readout on therapeutic potential.

Thanks, Priya. Let's move to the next question.

Hi, all. Thank you for taking my question. Chris, could you detail the rationale for adding more resources for the LEQEMBI launch and any changes in your partnership approach with Eisai that led to this decision?

Yes, Evan. To clarify, we are adding resources from both Biogen and Eisai. A year ago, both of us discussed the complexities surrounding the LEQEMBI launch and came to the conclusion that we needed to understand the go-to-market model thoroughly. We decided to start with one company's resources deploying a substantial field presence focused on those nuances before expanding, ensuring that we have the necessary teams and coordination established. We’ll refine our strategy based on what we learn from our experiences, and because we've gained confidence in our understanding, we are ready to deploy increased resources in the U.S. We're also ensuring the necessary core IDNs are activated before widespread deployment. We’re now more than six months into the launch and feel confident in our model. We are also applying our learnings to the Japanese market, taking a bi-national approach since many dynamics are consistent across both markets.

Thank you, Chris. Next question, please.

Hi, this is James on behalf of Paul. Thank you for taking our question. We want to clarify the status of the lecanemab subcutaneous filing and the safety data in the treatment-naive patient population. Are you confident about the data you have for the regulatory perspective?

Yes, this has been a significant topic of discussion between Eisai and Biogen regarding our FDA alignment. We designed a sub-study in the Phase III CLARITY study's open-label extension, with 72 treatment-naive patients and an additional 322 patients providing safety and tolerability data. Regulatory discussions have occurred, providing us with confidence in the data set established prior to initiating the studies.

Thanks, Priya. Next question, please.

Good morning. Regarding SKYCLARYS and following the EU approval last night, could you discuss the expected launch cadence and trajectory outside the U.S.? Particularly what you anticipate in major territories and whether you believe uptake will match the speed seen in the U.S.?

There are two launch aspects to consider: early access programs and a formal launch. For instance, we can commence formal launches in Germany post-approval, where early access programs transition into commercial patients. In Europe, patient revenues from early access programs should provide further support. Due to pricing and reimbursement challenges, this uptake might not match the speed seen in the U.S. However, there may be a more significant number of patients per capita in Europe since Friedreich's Ataxia has a higher incidence there.

We are actively pursuing regulatory filings in Latin America, particularly Brazil and Argentina, with our teams moving swiftly to discuss pathways for expeditious patient access.

We estimate a patient population of roughly 2,000 to 4,000 in Latin America, and based on our previous experience with SPINRAZA, we expect substantial contributions from this region to our revenue outlook.

Thank you. Next question, please.

Thanks. I wanted to discuss the dynamics surrounding the SKYCLARYS patient numbers, specifically regarding the growth from 800 to 1,000 patients and our expectations for 2024. How many of these are identified patients, and do you expect growth to moderate, considering what you mentioned about complexities in 2024?

Yes, we expect a moderation in growth. There was a high expectation with the previous product (by Reata), which neglected commercial launch capabilities. Once they gained market approval in February, they faced a manufacturing-specific issue that delayed product availability until July, resulting in significant past awareness. We are back to identifying patients; collaborating with the Friedreich's Ataxia Research Alliance has proved valuable in locating patients. Recognizing that diagnosis requires genetic testing, we have sought to ensure the associated supplies are readily accessible. We are also concentrating on establishing contracts to streamline patient initiation. Hence, we anticipate a standard growth trajectory continuing in the U.S., contributing significantly to our growth return in 2024.

Great. Thank you, Chris. Let's move to our last question, please.

Hey, good morning. Thank you for taking the questions. I wanted to clarify the timing around the subcutaneous filing referenced in your slides. Additionally, could you discuss the FDA requirements regarding necessary data for approvals? What are the current thresholds?

Eisai reiterated during their recent earnings call that we aim to file by Q1 2024, which means the end of March this year. With regards to the AHEAD 3-45 trial, this set of platform trials targets preclinical Alzheimer's disease with a high enrollment target. Specific design outlines various dosing phases with a focus on amyloid levels in patients. Primary endpoint details and exact timelines haven't been disclosed yet, but we’re optimistic about enrollment progress.

Thank you, Priya. Let’s proceed to our next question.

Thanks. I wanted to revisit the Angelman program. Can you clarify the decision-making process for future development and its comparative dynamics with Ultragenyx's program? In terms of endpoint assessments, how do you perceive your chances against the competitive landscape?

Certainly. Ionis leads the operationalization of this program, per our agreement that grants us the option to partake in future pivotal studies. The ongoing Phase Ib trial evaluates patient populations, assessing both safety and dosing parameters across various domains. We will analyze clinical and EEG data to gauge potential success for patients. Comparatively, we believe that our ASO approach is robust and markedly distinct from Ultragenyx's strategy while also ensuring adequate dosing frequency, which seems imperative to achieve significant clinical outcomes. With Roche discontinuing their program, we see potential competitive advantages imbued by our program’s design and framework, but ultimately, we await conclusive data.

Thank you, Priya. Let’s move to our last question.

Great, thank you very much for taking my question. I wanted you to comment on SPINRAZA's return to growth. What are the current market dynamics? How do you plan to reinstate growth for this product?

Certainly. Currently, we have an oral therapy and a gene therapy alongside SPINRAZA's intrathecal administration. In the short term, evidence supporting SPINRAZA's continued effectiveness following Zolgensma is crucial, as there are concerns about its long-term efficacy. We're also capturing switch backs while showing the oral treatment’s efficacy for diverse patient weights, targeting adult populations who remain undiagnosed. Generally, only about 30% of SMA patients are currently treated, but by refining our approach, we can locate the remaining reservoir of patients. In the long term, we’ve also developed a high-dose SPINRAZA program aimed at providing greater patient convenience and competitiveness against other therapies. Though this take process requires time, we anticipate our solution prior to patent expiration.

I'll quickly add that there is some lumpiness in revenue quarter-over-quarter, especially outside the U.S. However, our full year 2023 reports a modest growth trajectory aligning toward our expectations. We see the SPINRAZA franchise stabilizing sustainably across the board.

Yes, it’s essential to note that competition in the market has led to certain changes. Despite the entry of competitors, we’ve managed to retain a significant market share, and there’s a still substantial patient population available. Based on current trends, we are confident to navigate through the market effectively.

Great, thanks. That will conclude our call. Thank you all for being here today.

That concludes today's call. We appreciate your participation. You may now disconnect.