Document Details

**Operator** (Operator):
Good morning. My name is Anna and I will be your conference operator today. At this time, I would like to welcome everyone to the Biogen Second Quarter 2024 Earnings Call and Business Update. All lines have been placed on mute to prevent any background noise. After the speaker's 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.

**Chuck Triano** (Head of Investor Relations):
Thank you. Good morning, good afternoon, and welcome to Biogen's second quarter 2024 earnings call. During this call, we'll make forward-looking statements which involve risks and uncertainties that may cause actual results to differ materially from those in our forward-looking statements. We provide a comprehensive list of risk factors in our SEC filings, which I encourage you to review. Our earnings re...

**Operator** (Operator):
Good morning. My name is Anna and I will be your conference operator today. At this time, I would like to welcome everyone to the Biogen Second Quarter 2024 Earnings Call and Business Update. All lines have been placed on mute to prevent any background noise. After the speaker's 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.

**Chuck Triano** (Head of Investor Relations):
Thank you. Good morning, good afternoon, and welcome to Biogen's second quarter 2024 earnings call. During this call, we'll make forward-looking statements which involve risks and uncertainties that may cause actual results to differ materially from those in our forward-looking statements. We provide a comprehensive list of risk factors in our SEC filings, which I encourage you to review. Our earnings release and other documents related to our results, as well as the reconciliation between GAAP and non-GAAP results discussed on the call, can be found in the Investors section at biogen.com. We have also posted the slides on our website that will be used during this call. On today's call, I'm joined by our President and Chief Executive Officer, Chris Viehbacher; our Head and President of North America, Alisha Alaimo; Dr. Priya Singhal, Head of Development; Mike McDonnell, Chief Financial Officer, and we'll be introducing Dr. Travis Murdoch from HI-Bio on the call. We'll make some opening comments and then we'll move to the Q&A session. And 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.

**Chris Viehbacher** (CEO):
Thanks, Chuck. We have a lot to discuss this morning, but first, I want to introduce Dr. Travis Murdoch, a new member of our team. Travis is a physician trained in gastroenterology and has a background in immunology as a Rhodes Scholar at Oxford. After roles at McKinsey, Third Rock, and Softbank, he founded and became CEO of HI-Bio. I’m excited to welcome Travis and the HI-Bio team to Biogen, giving us a strong presence on the West Coast. The HI-Bio team will collaborate with their Biogen colleagues on the East Coast to advance the development of felzartamab. This morning, we’re announcing impressive quarterly results, but I believe this success is the culmination of efforts over the last 18 months. Eighteen months ago, we faced four consecutive years of decline in revenue and profit, and we have worked diligently to turn that trend around.  At our Q4 earnings in February 2023, we outlined five key priorities: focusing on new launches, reducing our cost base while aligning resources with growth opportunities, concentrating our R&D investments on promising assets, optimizing our existing portfolio, and pursuing external growth. Despite some setbacks, the results today demonstrate that Biogen has delivered on its commitments, which is crucial in business.  Regarding our new product launches, all are performing either in line with or ahead of expectations. I’m particularly pleased with the strong results for LEQEMBI, especially in the US and Japan, and I’m optimistic about early data from China. Last year, we set a goal to reduce our cost base, and we are exceeding expectations, as shown by the reduction in operating expenses and improvement in margins. One notable accomplishment is that while we’ve reduced costs and enhanced margins, we’ve substantially invested in growth opportunities for LEQEMBI and other launches, as well as in key R&D assets like BIIB080 and litifilimab.  Even though we’ve noted a decline in our MS portfolio due to intensified competition from biosimilars and generics, several of our products still enjoy strong patent protection. SPINRAZA has performed well in this competitive market, with good market share. I’m also happy to see VUMERITY experiencing double-digit growth in the US, making it the only patent-protected product in the oral MS segment, which presents a significant opportunity.  Additionally, our approach to external growth has yielded positive results, as illustrated by the Reata transaction last year, which is leading to successful launches in both the US and Europe. We anticipate being approved in 20 countries by the end of this year, and we’re very satisfied with the progress of ZURZUVAE, which addresses a major unmet need.  The results you see today are not just from the past quarter; they reflect the initiatives we've implemented over the last year and their early success. We still have opportunities for sustainable growth ahead. We believe the Alzheimer's portfolio will become a core focus for us, as we continue to invest in LEQEMBI and its related studies. The data we presented at AAIC regarding the 36-month findings are crucial for LEQEMBI's future growth.  We are also developing a lupus portfolio and look forward to updates on dapirolizumab and felzartamab, as they show great promise in treating lupus. Acquiring HI-Bio is pivotal for our long-term growth, providing opportunities with varied risk-benefit profiles. Observing strong Phase 2 results gives us confidence in anticipating Phase 3 results. Balancing our portfolio with immunology allows us to address significant unmet needs in neuroscience while managing risks. I'm genuinely enthusiastic about the potential of felzartamab and what Travis and his team will bring.  Furthermore, we will continue pursuing business development while maintaining discipline, as demonstrated by our acquisitions of Reata and HI-Bio, which align with driving shareholder value. Biogen is in a significantly improved position compared to 18 months ago. While we face challenges like any other company, we are well-prepared for long-term growth. Now, I’ll turn it over to Alisha for more insights on our successful launches.

**Alisha Alaimo** (Head of North America):
Thank you, Chris, and good morning, everyone. Thank you for joining the call today. Today I'll provide our perspective on the progress with LEQEMBI, SKYCLARYS, and ZURZUVAE. So I will begin with the Alzheimer's market. We believe we're continuing to build momentum with more health systems across the country now having the capability to treat a higher volume of Alzheimer's patients. And in Q2, we saw these promising trends continue. Notably, we sustained new patient growth. Nearly 40% of all commercial patients on therapy since launch started treatment during Q2. The number of physicians prescribing LEQEMBI also grew by 50%. Depth of ordering at our priority 100 IDNs continued to accelerate, and the total order volume more than doubled again in Q2 compared to Q1. It's important to know that based on the data we've seen to date, these trends continued into the first weeks of July, demonstrating that we are sustaining launch progress. We also believe we're seeing positive signals that health system capacity may be increasing. For example, last quarter, I described how some IDNs are expanding and extending their sites of care. Through Q2, nearly 70% of the activated priority 100 IDNs expanded beyond their flagship sites to treat patients at their trial sites. And we have seen this dynamic play out beyond the priority IDNs as well. We believe this growing real-world experience with LEQEMBI’s efficacy and safety further strengthens its unique profile in a newly competitive market. Specifically, some HCP share that because LEQEMBI was studied in the broadest and most diverse population of any anti-amyloid drug today, it removed some of the complex considerations about which potential patients are appropriate for Alzheimer's treatments. Alzheimer's is a chronic, degenerative, and fatal disease that does not stop even after plaque is removed. In fact, our long-term data show that patients who stopped LEQEMBI treatment experienced rapid re-accumulation of key plasma biomarkers that indicate Alzheimer's disease biology was returning. Importantly, the rate of decline in most patients who stopped therapy were reverted to the rate of decline observed in patients who took placebo, which is why we believe patients deserve a therapy with a benefit-risk profile that enables them to remain on treatment to stay ahead of disease progression, even after removing plaques by preventing ongoing damage and plaque buildup. Recent data that Priya will describe reinforces that in patients with three years of continuous treatment, LEQEMBI showed continued benefits. And finally, though there are no head-to-head studies comparing the available therapies, the FDA has been clear that the incidence and timing of ARIA vary among drugs in this class. Observed ARIA rates in patients who receive LEQEMBI were the lowest reported among any Phase 3 trial for a drug with traditional FDA approval in the class, with LEQEMBI rates nearly 50% lower. To reinforce LEQEMBI's unique profile with our customers, Biogen deployed our expanded field force just last month. This team increases our focus and frequency, engaging with high-value sites, and expands our reach to 30% more HCPs. We've been receiving positive feedback since the launch of this team. Biogen's field force is working even more closely with our partner Eisai, and we believe this is deepening our customer insights and will enable accelerated growth. We're encouraged by two strong quarters of growth and the sustained progress in July, and we look forward to providing more support to the healthcare community and people living with Alzheimer's disease. Now, moving on to the SKYCLARYS update, where we continue our strong launch momentum reaching more Friedreich's Ataxia patients globally. In the second quarter, we delivered $100 million in revenue globally and remain ahead of our internal expectations. The Europe launch is ahead of the internal forecast and along with the rest of the world builds on the success in the US. SKYCLARYS is now available in 12 markets outside the US including the EU where we are initiating new patients in the catch-up population. These patients and their HCPs are highly engaged in their care and often awaiting SKYCLARYS approval, as is typical for rare disease launches. In the US, we have moved beyond the catch-up population as SKYCLARYS has been in the market for more than a year. The team continues to leverage our strong rare disease capabilities and we are encouraged by the early results of engaging patients and physicians in this next phase. In Q2, roughly one-third of new patient start forms came from new writers tied to our AI program, which analyzes hundreds of thousands of de-identified patient journeys. This includes a meaningful share from community neurologists and PCPs. Globally, our outlook in FA is promising in both the short and long term. We anticipate driving strong growth by making SKYCLARYS available in additional geographies, potential expansion into pediatric populations, and with our years of experience identifying patients, we believe we can help. Turning to ZURZUVAE, we continue to outperform our expectations in the first six months of launch. We saw strong growth in the second quarter with US revenue growing 19% and patient demand nearly doubling versus the first quarter. OB-GYNs continue to lead prescribing, and patients are sharing positive early experiences with their physicians and on social media platforms. Based on our recent market research, we believe we've achieved higher than average aided awareness of ZURZUVAE among providers, outperforming competitors in the women's health and psychiatry markets. To achieve the next phase of growth and advance our vision to transform the care of postpartum depression, we are working to more deeply understand how to realize the patient opportunity in this market and drive real behavior change. In conclusion, while each launch is unique, we are pleased that we remain on track or ahead of our expectations across all three therapies. We know we have more work to do to help people living with Alzheimer's, Friedreich's Ataxia, and postpartum depression, and we are working with urgency to help these patient communities. I will now pass to Priya.

**Priya Singhal** (Head of Development):
Thank you, Alisha. Over the last year, we have focused heavily on reviewing our existing pipeline with an eye toward improving its risk profile. The focus now is on building the pipeline through a combination of both internal and external opportunities with an eye towards risk diversification and creating value. We also remain focused on investing to win in Alzheimer's disease, where we believe we have a differentiated product in LEQEMBI, as well as an industry-leading R&D pipeline of potential next-generation therapies. Beginning with LEQEMBI. LEQEMBI is the only approved anti-amyloid antibody with, first, a dual mechanism of action targeting both amyloid plaques and highly toxic protofibrils. Second, clinical data across the full early Alzheimer's disease population, including individuals with no and low tau. And third, extensive real-world evidence. Importantly, as Alisha mentioned, Alzheimer's disease is a chronic progressive disease, and we believe the dual action of LEQEMBI and the option for continued treatment is a unique advantage for patients looking to maintain or further clinical benefit. To this point, at AAIC earlier this week, Eisai presented three-year data from the Phase 3 CLARITY study and its open-label extension, which shows continued clinical benefit with longer duration LEQEMBI treatment. Shown on the left, this includes data from the early start group or individuals who started LEQEMBI during the 18-month placebo-controlled portion of the study, the delayed-start group or patients from the placebo arm who switched over to LEQEMBI at the start of the open-label extension, as well as a baseline matched natural history cohort from ADNI. The early start group shows that three years of continuous LEQEMBI treatment reduced clinical decline by negative 0.95 on CDR sum of boxes as compared to the natural history cohort, resulting in a clinically meaningful benefit for early AD patients. This represents an expansion of the benefit observed at 18 months. It is very important to keep in mind that a change from 0.5 to 1 on the CDR score domains of memory, community affairs, home and hobbies is the difference between slight impairment and loss of independence. We believe these results are significant as the majority of individuals, approximately 70%, had already successfully cleared plaque by the 18-month time point. Furthermore, data from the lecanemab Phase 2 study, shown on the right, which included a treatment gap of approximately two years on average, shows that Alzheimer's disease continues to progress when treatment is stopped or interrupted even after plaques are removed. Also at AAIC, Eisai presented data which showed that 51% of patients in the CLARITY AD study with either no or low tau representing an early stage of Alzheimer's showed improvement from baseline in cognition and function over a three-year period as assessed by CDR sum of boxes. Taken together, these data suggest that earlier initiation of treatment with LEQEMBI may have a significant positive impact on disease progression and may provide continued benefits to patients with early Alzheimer's disease over the long term. We continue to focus our efforts on LEQEMBI with a goal of characterizing dosing for its long-term benefit, providing optionality with subcutaneous formulation, as well as evaluating its role in preclinical AD population, as Chris mentioned. Lastly, while we were disappointed to learn that lecanemab received a negative opinion from the CHMP, we believe that the clinical data supports a clear favorable benefit-risk profile with a meaningful clinical benefit to patients. Furthermore, thousands of patients have now been treated with lecanemab globally, providing further real-world evidence on the efficacy and manageable safety profile. We are continuing to work with Eisai as they plan to request a re-examination of the EU filing as we work to enable access for people suffering from Alzheimer's globally. We continue to also invest in our broader Alzheimer's pipeline, including our investigational anti-tau ASO BIIB080. Based on the encouraging data from the Phase 1b study, we have now implemented a protocol amendment for the ongoing Phase 2 CELIA study with the aim of accelerating a potential proof-of-concept outcome. We are excited that this amendment, combined with the robust enrollment trends observed to date, may enable a readout in 2026. Beyond amyloid and tau and under Jane's guidance in research, we are advancing a preclinical AD pipeline that encompasses diverse targets and modalities, including active transport approaches. As communicated today in our earnings release, we decided to exit the ATV:Aβ collaboration with Denali. We continue to see merit in modalities that can actively transport therapeutic agents into the brain. And we continue to prioritize these efforts as we work to build upon our existing leadership in AD. Looking back over the last few months, while we discontinued three mid-stage programs based on readouts, we continued to make progress across several other areas of our pipeline. The first patient has received a dose of SKYCLARYS in Biogen's Phase 1 dose-finding study for pediatric Friedreich's Ataxia. This is the first step in potentially expanding SKYCLARYS access to the pediatric population. And once a dose is identified, we plan to conduct a Phase 3 study to assess the benefit/risk in pediatric patients. We also expect the DEVOTE study evaluating high dose SPINRAZA to readout in this second half of the year. We have also made meaningful progress in immunology where the first patient was dosed in the litifilimab Phase 3 portion of the operationally seamless Phase 2/3 Amethyst study in CLE following the completion of the Phase 2 enrollment. As Chris mentioned, we continue to view immunology as a significant potential driver of Biogen's future growth and the recent acquisition of HI-Bio is an example of this importance. With that, I would like to hand over the call to Travis, who will dive a bit deeper into felzartamab.

**Travis Murdoch** (New Team Member from HI-Bio):
Thank you, Priya. I'm very excited to be here speaking today as part of the Biogen team. I believe we have a unique opportunity to combine HI-Bio's expertise in immune-mediated indications with Biogen's global development and commercial experience in specialized immunology and rare diseases. I believe this synergy will have significant benefit as we work to accelerate our lead asset, felzartamab, or felza, into late-stage development. As an anti-CD38 antibody, we believe felzartamab has a differentiated molecular design that specifically targets and depletes plasma cells responsible for producing pathogenic antibodies, while sparing the broader B-cell lineage. This is different from other programs currently in development for antibody-mediated diseases that more broadly impact B cells. Compared to other mechanisms, we believe the specificity of felza's MOA may allow for a differentiated and more desirable clinical profile characterized by more durable efficacy and improved safety profile. As Chris mentioned, one of Biogen's goals is to optimize the risk/reward of the pipeline and I believe the acquisition of felza significantly advances that effort. Through its cell depletion approach, felza has already demonstrated clinical proof of concept across multiple rare immunology indications. Antibody-mediated rejection, AMR, IgA nephropathy, IgAN, and primary membranous nephropathy, or PMN, are serious conditions that lead to severe consequences for patients, such as transplant failure or end-stage kidney disease, and available treatment options leave significant unmet needs. And so, we see significant potential commercial opportunity here. Now I'd like to briefly review the felza data generated to date across these indications to highlight the potential value we see for patients. AMR is the leading cause of kidney transplant loss in the US, with no approved treatments, and prior investigational agents have not demonstrated significant resolution of AMR on biopsy. The consequences here can be dire, ending with graft failure, dialysis, and a need for retransplantation in many cases. In the Phase 2 study, which we published in The New England Journal of Medicine, nine doses of felza IV administered over a five-month period resulted in greater than 80% AMR resolution at week 24 versus 20% for the placebo group. Furthermore, two-thirds of responders maintained AMR resolution out to 52 weeks. So we believe these results, if replicated in a registrational study, are potentially transformative for this disease. Next, I'd like to discuss IgA nephropathy, or IgAN, which is the most prevalent chronic glomerular disease worldwide and another indication where we believe felza has the potential to deliver a treatment option for patients with important differentiation. Felza directly depletes CD38 positive plasma cells, the producers of both galactose-deficient-IgA1 and its autoantibody, which are believed to be the most upstream causes of IgAN. As shown here on the slide, felza treatment resulted in durable reductions in IgA up to 24 months, which is more than 18 months after the last dose. Importantly, this pharmacodynamic effect was selective for IgA, with IgG and IgM levels rebounding to baseline after the completion of the five-month felza treatment. These results, paired with the emerging clinical efficacy data, suggest that felza could have a durable selective effect on IgA and thus impact IgAN disease biology while potentially allowing for the maintenance of general protective immunity conferred by IgG and IgM antibodies over a prolonged period on therapy. Similar to the effects we saw in IgA, interim results from the Phase 2 IGNAZ study showed a durable reduction in proteinuria as measured by UPCR. Specifically, we saw there was a dose-dependent reduction in UPCR, durable out to the 24-month time point. Now in terms of potential differentiation, it's important to note that this improvement is after more than 18 months of being off therapy, supporting the potential for felza to be the first non-chronic treatment option in IgAN. Furthermore, in line with the selective targeting of plasma cells, administration of felza was generally well tolerated with the safety profile consistent with prior studies. We believe these interim results potentially provide for a wide therapeutic window and may ultimately lower the risk of chronic immunosuppression, which could be a significant benefit for IgAN patients. Moving to PMN. So this is a severe antibody-mediated disease in the kidney that's a leading cause of nephrotic syndrome, which is a severe syndrome resulting from excretion of too much protein in the urine and which causes symptoms such as swelling, fatigue, and increased risk of infection. Current standard of care, which includes immunosuppressive and chemotherapeutic agents, has proven insufficient as up to 40% of patients do not achieve remission and many progress to end-stage kidney disease. It's estimated that up to 80% of patients with PMN have autoantibodies against PLA2R, which is a kidney antigen and which provides us with a key biomarker both for patient stratification as well as treatment response. In the Phase 2 M-PLACE study, which evaluated felza in both newly diagnosed and relapsed patients as well as patients refractory to immunosuppressive therapy, a 24-week felza treatment resulted in a rapid, deep, and durable reduction in anti-PLA2R antibodies in both patient cohorts at the one-year time point. Many patients retained immunologic complete responses more than six months after the last dose of felza, which highlights the durability of felza's treatment effect. Importantly, the effect on anti-PLA2R was mirrored when examining reductions in proteinuria. And in line with prior studies of felza, TEAEs were generally mild or moderate in severity. Based on these results, we believe that felza has the potential to provide a meaningful new treatment for patients suffering with PMN. In summary, we believe the data generated to date highlight the potential for felza to be a best-in-class treatment option across multiple serious immunologic diseases with significant unmet needs. Phase 2 data across AMR, IgAN, and PMN have provided proof-of-concept and highlighted a potentially differentiated clinical profile on the basis of efficacy, treatment durability, and safety. I'm looking forward now to combining the strengths of the joint HI-Bio and Biogen team as we work to incorporate these learnings and further refine our Phase 3 plans. Now we expect to initiate Phase 3 studies across AMR, IgAN, and PMN next year, beginning with AMR in the first half of the year. I'd now like to pass the call over to Mike for a financial update.

**Mike McDonnell** (CFO):
Thank you, Travis, and good morning, good afternoon to everyone. I'd like to start by acknowledging the entire Biogen team for a strong second quarter. I'm pleased to provide some color on the results, and please note that all the comparisons that I will make are versus the second quarter of 2023. Total revenue of $2.5 billion was up marginally versus the prior year at actual currency and grew 1% at constant currency. But importantly, we grew our core pharmaceutical revenue 5% at actual currency and 6% at constant currency. This was driven by the performance of our four recent launches, which more than offset the revenue decline in our MS business. Non-GAAP diluted EPS grew 31% to $5.28 and included a one-time benefit of $0.52 from the sale of one of our two priority review vouchers. Absent the PRV sale, non-GAAP EPS would have grown 18% to $4.76. We also reported a 43% improvement in non-GAAP operating income, which was a 30% improvement excluding the PRV sale. We continue to benefit from our R&D prioritization and fit-for-growth initiatives, where I'll provide more detail in a moment. We are pleased to be raising our full-year 2024 guidance range. And in just a few moments, I will also provide some additional details on our guidance. Now a bit more color on our revenue for the second quarter. Our MS franchise revenue declined approximately 5% in the quarter, and there are a few dynamics in this business that are worth highlighting. First, we continue to see erosion of our interferon business as the entire class is seeing a shift to higher efficacy or oral therapies. Regarding TECFIDERA in the EU, we have now seen most generics exit the market, which helped drive ex-US growth of 11% at actual currency and 12% at constant currency to $208 million this quarter. We continue to believe that we are entitled to market protection in the EU until February of 2025. VUMERITY had its best quarter since launch as global revenue grew 13% at actual and constant currency to $166 million. VUMERITY remains the number one branded oral in terms of share in the US. US TYSABRI revenue of $249 million declined 4% and benefited from the timing of shipments in the quarter, which was offset by declines due to competition within the high efficacy class. Next, our rare disease franchise produced revenue of $534 million and that represented growth of 22% at actual currency and 25% at constant currency. SKYCLARYS global revenue was $100 million. Global SPINRAZA revenue of $429 million declined 2% at actual currency and was flat at constant currency. US revenue was up 1% to $157 million, and we remain encouraged by the resilience here. And on LEQEMBI, we saw significant sequential growth with second-quarter global in-market sales booked by Eisai of approximately $40 million, which included $30 million of US in-market sales. I'll turn now to a few comments on expenses. We continue to see lower non-GAAP cost of sales as a percentage of revenue, which was driven by a more favorable product mix, notably growth in SKYCLARYS replacing lower-margin contract manufacturing revenue. We also had no idle capacity charges during the quarter versus $34 million in the second quarter of 2023. As mentioned previously, our R&D prioritization and fit-for-growth programs have begun to significantly improve our profitability. Second-quarter non-GAAP R&D expense decreased from the second quarter of 2023 by $120 million or 21% as we continue to focus our spend on programs with the highest probability of success. Non-GAAP SG&A expense increased 1% in the second quarter. We have significantly reduced selling costs for legacy products and also significantly reduced our general and administrative cost base, which has allowed us to absorb most of the approximately $100 million of Q2 2024 incremental launch costs for LEQEMBI and SKYCLARYS. Now, a brief update on our balance sheet. We ended the second quarter with $1.9 billion of cash and marketable securities. As a reminder, we utilized $1.15 billion of this balance in July when we closed the HI-Bio acquisition. We ended the quarter with approximately $4.4 billion of net debt. During the quarter, we fully repaid the remaining balance of the $1 billion term loan that we put in place at the time of the Reata acquisition. And we continue to generate strong cash flow in the second quarter with approximately $592 million of free cash flow, which brings us to approximately $1.1 billion of free cash flow in the first half of 2024. We continue to believe that our balance sheet has the capacity for us to invest in both internal and external growth opportunities. Turning now to guidance. We're pleased that the operating performance of the business year-to-date supports raising our full-year 2024 non-GAAP diluted EPS guidance from a previous range of $15 to $16 to a new range of between $15.75 to $16.25. This new range reflects expected growth of approximately 9% at the midpoint of the range compared to the full year of 2023. I would like to highlight several important things to remember for the second half of 2024 as you update your models. In terms of revenue, with our key products all performing generally in line or slightly ahead of expectations, there is a slight increase to the previous expectations for the year. We now expect full-year total revenue to decline by a low-single-digit percentage when compared to 2023. We also expect core pharmaceutical revenue to be roughly flat year-over-year as recent launches are expected to progress and provide an offset to some key potential dynamics in the second half of the year. These include expected continued pressure on our MS franchise, which incorporates the potential for a biosimilar entrant in the US for TYSABRI, and we continue to monitor the timing of shipments for SPINRAZA in certain ex-US markets. Next, the sale of one of our two priority review vouchers is a non-recurring item. And since we expect to reinvest the proceeds of this sale in growth initiatives later this year, we do not expect this benefit to impact our full-year EPS. Also, some key points to consider regarding our operating expenses. In the second half of the year, we expect to continue to ramp launch spending on our new product launches. This will include the 30% increase in the LEQEMBI field force, which is coming online as well as additional spend for some targeted direct-to-consumer campaigns. In addition, we expect incremental OpEx, primarily on the R&D line, of approximately $50 million in the back half of the year related to HI-Bio as we execute plans on three potential Phase 3 starts. We continue to expect full-year 2024 combined non-GAAP R&D and SG&A expense of approximately $4.3 billion. We reported approximately $2 billion of spend in the first half of the year, implying higher spend in the second half of the year due to the reasons I just mentioned, along with some typical phasing of expenses throughout the year. I would also note that we now expect 2024 operating income to grow at a mid to high teen percentage versus the previous guide of low double-digit percent growth. This improvement factors in higher expenses in the second half of the year versus the first half of the year, partially offset by higher revenue due to our new product launches. I would remind you that we expect a reduction in interest income of approximately $20 million for the remainder of 2024, and this is due to lower cash balances and associated lower interest income resulting from the HI-Bio acquisition. As always, our guidance does not consider the impact from any potential acquisitions or large business development transactions or pending and future litigations as these are often difficult to predict. I would refer you to our press release for other important guidance assumptions. And just before we open it up for Q&A, I wanted to provide a brief update regarding the strategic review of our biosimilars business. After a comprehensive review of potential externalization options compared to retaining the business, we believe that the best value for shareholders going forward is to retain the business within our portfolio and to optimize the business with an aim to maximize profitability. And with that, we will open up the call for questions.

**Chuck Triano** (Head of Investor Relations):
Thanks, Mike. Operator, can we please poll for questions?

**Salveen Richter** (Analyst):
Good morning. Congratulations on the quarter. At a high level, there's been significant focus on 2024 as a turning point for the company, both product-wise for the launches and operationally, given the cost savings programs and pipeline prioritization. Just given the raised guidance here of 9% year-over-year EPS growth for this year, can you just speak to your confidence around 2023 being the trough year for earnings and what needs to play out from here for clean growth through the end of the decade? Thank you.

**Chris Viehbacher** (CEO):
Yeah, thank you for the question, Salveen. And our mission at Biogen remains to bring ourselves to sustainable growth on both the top line and the bottom line. Obviously, our original guidance, which implied growth of 5% on the bottom line at the midpoint and now 9% at the midpoint, shows that we've now turned the corner on the bottom line and we're very focused on our cost savings program, which importantly not only improves our operating performance, but also frees up capital for growth initiatives. So that's real important. Obviously, we don't guide beyond 2024, but I would say that when you look at our guidance this year, we're pleased with the fact that we've been able to get our top line somewhat much more stabilized, and we've got the bottom line growing again as we look to next year. We're pleased with the progress of the launches. Our ability to restore the top line is going to be somewhat dependent on how those launches continue to perform along with how the MS franchise continues to sustain and be durable. And what I can say is that we're very focused on bringing the company back to growth. And we're certainly hopeful that 2023 was the trough year. And obviously, we're doing a nice job growing the bottom line in 2024, and we'll have more to say about the out-years as we move to the latter part of this year and into early next.

**Chuck Triano** (Head of Investor Relations):
Thanks, Mike. Can we take our next question, please, operator?

**Unidentified Analyst** (Analyst):
Hi, this is someone on for Mohit. Thank you for taking our questions. I wanted to ask about the EMA decision on LEQEMBI. Do you intend to submit additional evidence regarding efficacy or safety from trials or real-world data to reverse this decision? How confident are you that this decision can be changed? Also, what should we anticipate in terms of the timeline for the EMA to reconsider, and would a SAG need to be convened for this process? Thank you.

**Priya Singhal** (Head of Development):
Thank you. This is Priya Singhal. We are very disappointed, along with Eisai, at the outcome of the negative opinion for LEQEMBI. We continue to believe that the benefit/risk is positive and favorable. As you know, it's been approved in major regions of the world like the United States, China, Japan, and recently, we've also communicated approvals in Hong Kong, Israel as well as South Korea. So, yes, we have communicated publicly, and I can reaffirm that we will be applying for a re-examination process. The way the re-examination process works is that you can continue to work with a newly appointed rapporteur and co-rapporteur for the process. So, right now, we would wait to receive the assessment report from the CHMP, the new rapporteur and co-rapporteur would be appointed, and then we would work with them to understand what are the issues that are driving the decision. And currently, based on the opinion that was rendered, we believe these are addressable with the data that we've generated. Specifically, we have generated long-term data, as we shared at AAIC, and we would look to be engaging with the EMA and CHMP to see how we can submit additional data on the extensive real-world data that we have because thousands of patients now have been treated. So we have long-term continued benefits, as we showed in the three-year data at AAIC, and also long-term safety. So we're continuing to work very closely with Eisai on the re-examination process and strategy. It is possible that a new SAG-N would be appointed, and this process would generally move faster than the original application.

**Chuck Triano** (Head of Investor Relations):
All right. Thanks for the details, Priya. Next question, please.

**Kevin Seigerman** (Analyst):
Hi there. It's Evan Seigerman. Question for Priya. Can you walk me through some of the rationale on opting out of the Angelman Syndrome Program with Ionis? How has your approach to evaluating partnerships evolved recently, and what aspects of a program do you now more closely scrutinize when you're thinking about what to do with a partner?

**Priya Singhal** (Head of Development):
I want to emphasize that we view our readouts as significant inflection points that can either lead us to intensify and accelerate our programs if the data is clear and compelling, or to shift our focus to other projects we may be considering. Our approach involves establishing a priority go/no-go criteria, which helps us evaluate the likelihood of technical and regulatory success in a specific program. This methodology was applied to the Angelman Syndrome and BIIB121 data. We will continue to apply this disciplined approach to all our readouts. Key factors we find compelling include biomarkers, established regulatory pathways, clinical feasibility, and our confidence in regulatory endpoints based on our interactions with regulators. These considerations guide our investment decisions in Phase 3.

**Chris Viehbacher** (CEO):
If I could just add, I think, in addition to what Priya said, we're also looking at the ability to launch products globally. And so, we also are interested in the level of evidence and regulatory endpoints as they may be acceptable to payers and regulators around the world and not just in the US.

**Chuck Triano** (Head of Investor Relations):
Great. Thank you both. Next question, please, operator?

**Michael DiFiore** (Analyst):
Hi, guys. Thanks so much for taking my question, and congrats on the quarter. So I was wondering if there's any updates on the subcutaneous induction dose optimization work you're doing and whether this could lead to a more optimal risk/benefit ratio that the EMA is looking for?

**Priya Singhal** (Head of Development):
Yes. Overall, as Eisai and Biogen have communicated, we have already filed for the IV maintenance, and we have fast track and rolling submission in place for the subcutaneous maintenance dosing. With the initiation of subcutaneous dosing, we are looking to optimize the dose. We are continuing to work with the FDA on this effort. Currently, we are on track to receive an outcome from the FDA in the US by the first quarter of 2026. Regarding your specific question about how this could impact the application in Europe, I want to clarify that the re-examination application in Europe is dependent on the original application for intravenous LEQEMBI. We hope to get a favorable outcome at the end of the re-examination process, and if successful, we would continue providing options to patients in Europe with the subcutaneous formulation.

**Chuck Triano** (Head of Investor Relations):
Thank you, Priya. Next question, please.

**Nicole Gabreski** (Analyst):
Thanks. This is Nicole Gabreski on for Chris. Maybe just one on LEQEMBI. So some of our survey work we've done recently with neurologists and Alzheimer's specialists has indicated maybe a less favorable view of the risk/benefit and cost/benefit ratios for LEQEMBI in recent quarters. And I guess we're starting to see some feedback from docs also questioning the amyloid hypothesis as a whole. I guess, maybe just given this, could you speak to the interactions and/or feedback that reps are having in the field? I guess, are you starting to maybe experience any pushback as you move from HPPs who are sort of ready and waiting to prescribe LEQEMBI soon after approval to those who are in the next wave of uptake?

**Alisha Alaimo** (Head of North America):
Thank you for the question. This is Alisha. Whenever we look at market research, I think it's important to understand who you're asking in the market research. And so, when we look at what's happening in the field, at least on the ground, when you're asking the physicians, if you were to parse out market research and ask the physicians who are currently obviously prescribing, and the ones who aren't, the ones who are prescribing are the ones that we've been working really hard on over this past year. They're the ones that understand the data, they've been visited by MSLs, they've been visited by representatives, and then it takes them time to obviously get up and running with their facility. You also then see across the board that other physicians see this happening and some in, like, a nearer location will also start obviously picking up the product. And so, on the ground and with our representatives, they go from office to office. We're obviously expanding now as well with the additional field force. And what we've seen is the ones that you call on are the ones that actually start writing. And there's a lot of dynamics at play here. I think that understanding this data is important. I think understanding all the mechanics in order to get a patient diagnosed is important and having them set up their capacity is important. And so, we don't really hear any pushback about cost/benefit. I can say that. And I think more importantly, what we're hearing now is because we are a year out, we're starting to really get the real-world experience feedback from physicians on the impact this is having on patients and the caregivers and the families. And I think that alone has really also accelerated some of these physicians to try and treat patients even more quickly. And so, for now, we're not really hearing that pushback.

**Chris Viehbacher** (CEO):
I have learned over the years to focus more on the actions of physicians rather than their words. Introducing this treatment in their practices and institutions is a significant challenge for them. The fact that there has been a 50% increase in physicians prescribing this treatment, along with the deep engagement from integrated delivery networks, indicates that many physicians are dedicating substantial time and effort to navigate the necessary processes, including scheduling PET scans, lumbar punctures, and MRIs. This level of commitment demonstrates their strong belief in the value of this treatment for patients. As I assess the situation, I feel very optimistic about our position. For the first time since our launch, we can anticipate growth in this market, driven not only by prescriptions but also by the solid evidence we are creating in partnership with Eisai regarding LEQEMBI. The three-year data suggests that merely clearing the plaque may not be sufficient; ongoing treatment for patients will be necessary. Additionally, with the AHEAD study, we aim to demonstrate the advantages of early treatment. This market is set to expand, and the supporting evidence will grow as well. We are in the process of building this market, which certainly requires time and patience. However, based on this quarter's performance, it appears we are on a very promising path. I believe the entry of Lilly will further enhance the development of this marketplace.

**Chuck Triano** (Head of Investor Relations):
Thank you. Let's take our next question, please.

**Unidentified Analyst** (Analyst):
Hi, everyone. This is Nevin on for Brian here. Congrats on a good quarter and thank you in advance for taking our questions. I just wanted to ask a little bit more about the SKYCLARYS dynamics that we're seeing, specifically what you're seeing on patient persistence or potential discontinuation rates there. Some of the educational efforts that you're taking to kind of convince the patients to remain on therapy even if they're not seeing the efficacy of the therapy right away. And maybe if you could speak a little bit more to some of the perceptions that patients and doctors may have on the cardiac safety and benefits there as well. Thanks.

**Alisha Alaimo** (Head of North America):
All right. Thank you for the question. This is Alisha. First, we are very pleased with what we're seeing right now, especially globally and in the US with SKYCLARYS. And as I've mentioned before, we're past the catch-up population and we're now really into the patient identification phase. We look at every metric from discontinuation, compliance, adherence, to start times. And when it comes to discontinuations, we do not see anything outside of what you see in the clinical trials. And so, the discontinuation rate is not anything more than obviously what we also saw in trials. I think when it comes to efficacy of the patients, physicians have been really good on setting expectations with patients on what to expect from SKYCLARYS. The field teams do a really good job of also educating both physicians and educational materials with patients on what to expect when you start this product. And so, you do see that patients tend to stay on product, and physicians are very good also about saying to patients, at least stay on it for a year and let's talk about how you're feeling and where we're going and what we're seeing as adherence has been actually very good. I think the other dynamic that's playing out that you could be referring to is because we're now in the patient identification phase, you are going to see a little difference from week-to-week and month-to-month. And we are adding patients every single week. We're also adding them every single month. And we acquire new data on a regular basis. And what we're seeing, at least recently, and I was sharing this with Chris the other day, we have this new AI engine that we've been deploying and we have identified a significant number of additional coded FA patients that we didn't even have at the beginning of the launch because we're starting to see that patients are engaging even more with their physicians. And so, now we're able to reach them with more efficiency and with more certainty across the board. And I think it's been very promising as we find new patients to come on.

**Chuck Triano** (Head of Investor Relations):
All right. Thanks, Alisha. Next question, please.

**Paul Matteis** (Analyst):
Great. Thanks so much for taking my question. I think over the past year, Biogen's commentary on business development capacity has evolved a couple of times. And more recently, I think you said around $10 billion, maybe minus the HI-Bio deal. I guess just kind of going forward in 2024 or the near to mid-term, what's Biogen's appetite for bigger transactions or Reata-like transaction and what's the updated thinking on specific therapeutic areas or types of assets of interest? Thank you.

**Chris Viehbacher** (CEO):
I will address that. First, I want to mention that we are already deeply invested in neuroscience, so we are likely looking beyond that area, specifically at immunology and rare diseases. Biogen possesses significant scientific and medical expertise, and we have traditionally focused on low-volume, high-value products. We recognize the importance of helping patients and physicians navigate reimbursement challenges, including by sponsoring genetic testing. Studies and real-world evidence are also critical for us. Therefore, I believe Biogen has the potential to excel in rare diseases, and our experience in immunology dates back to our work with multiple sclerosis.  Currently, we are in a growth phase and would be interested in finding another acquisition similar to Reata, though such opportunities are uncommon. It's not often that we come across a company that is almost at market launch when we acquire it, especially at a price that adds value for shareholders. We will continue to search for such opportunities, but we are not in a hurry to make a deal.  For example, our work with HI-Bio reflects our intent to launch more products in the 2027 to 2030 period, which is a priority for us, so we are focusing on mid to late-stage development. We can be selective in our investments, and we aim to avoid competing in auction processes where value creation can be compromised. By concentrating on specific areas where Biogen can excel, we can minimize the risk of overpaying. Another point to note is that Biogen is sized such that a $1 billion deal significantly impacts our operations, unlike larger companies where that amount might be negligible. We can pursue assets that may be overlooked by larger firms yet considered too costly by smaller companies. This places us in a good position to seek valuable assets without entering highly competitive environments, thereby reducing the chances of overpaying. We are taking a systematic approach to our strategy without making sudden, drastic changes because we want to focus on what aligns with Biogen's strengths. I believe there are several opportunities available, and we are also increasing our research collaborations. It would be great to bring in more early-stage assets since acquiring them sooner tends to generate more shareholder value.

**Chuck Triano** (Head of Investor Relations):
Thanks, Chris. Next question, please.

**Michael Yee** (Analyst):
Hey, guys. Thank you. Earlier in the call, you commented about an emerging lupus portfolio, and I know that you do have some upcoming lupus data. We've looked at the prior data. There are reasons to believe that longer treatment and a bigger study could help here. Can you just speak to your expectations? What are you looking for? What needs to happen to move forward? Etc., etc. Thank you.

**Priya Singhal** (Head of Development):
Yes, thank you. This is Priya Singhal. Overall, we are excited about the upcoming readouts for dapi in the next several weeks. This is a partnered program with UCB and the collaboration is in a very good place. We expect to see top-line results from the first global Phase 3 trial. I want to clarify that this study is looking into the safety and efficacy of dapi as an add-on to standard SLE therapy compared to a placebo as an add-on to standard SLE therapy in a high unmet disease area. We are conducting this study in patients who experience persistent active symptoms or frequent flares despite stable standard care. Similar to the Phase 1 and Phase 2 studies, we will assess efficacy using the BILAG-based Composite Lupus Assessment, or BICLA, but this time it will span 48 weeks to demonstrate long-term effects. We have also increased the sample size to ensure a substantial dataset on safety and efficacy. Ultimately, we aim to achieve a meaningful change in the primary endpoint and key secondary outcomes, such as preventing severe flares and helping patients reach low disease activity. We believe BICLA is a sensitive and clinically relevant composite measure for SLE disease activity, requiring improvement across all body symptoms with moderate or severe baseline activity, and without the escalation of steroids or other background medications, as well as no worsening. We look forward to these results. In addition to an acceptable safety and tolerability profile, we believe this could be significant for patients with SLE. If the results support further development, we anticipate needing to conduct another Phase 3 trial, and we are currently planning for some of this at risk.

**Chuck Triano** (Head of Investor Relations):
Thanks, Priya. Next question, please.

**Eric Schmidt** (Analyst):
Thanks for taking my question. Maybe for Chris, this call today seems to be like a relative high watermark in your tenure as CEO, given some of the initiatives that are now well in place and all that you've accomplished. And you certainly called that out in your prepared remarks. You also called out that you've got some challenges and you're not done. So, what in particular is top-of-mind there? Thank you.

**Chris Viehbacher** (CEO):
Thank you for your question. I hope this isn't the peak, as we are aiming for much greater achievements. We still face competitive challenges with our MS franchise, including a potential biosimilar for TYSABRI and an important patent litigation for TECFIDERA in Europe, alongside market exclusivity expiring in February. In the short term, there will be some fluctuations. However, we have a talented team at Biogen. I've been in the industry for a long time and I'm continually impressed by our scientific and medical expertise, along with our available capital. I believe we can make smart investments with it. We've been focused on transforming inactive capital into active investments. For example, we converted a priority review voucher we've had for six years into an active asset, which we sold with the goal of using the proceeds for business development milestones in the latter half of the year. Additionally, with HI-Bio, we redirected savings from our operating expenses into growth through acquisition. I see us having modified the company's trajectory by reallocating resources effectively. We're now focused on enhancing our R&D portfolio, both internally and externally, emphasizing that we want to remain an innovation-driven company. My focus is on the 2025 to 2030 timeframe, and I believe we are positioned well for growth during that period. We will continue to be disciplined in our capital deployment, converting inactive capital into active investments that foster growth.

**Chuck Triano** (Head of Investor Relations):
All right. Thank you, Chris. And thank you, everybody, for joining us today. The IR team will remain available for any additional questions. Thank you.

**Operator** (Operator):
And once again, that does conclude today's conference. We thank you all for your participation. You may now disconnect.