The paragraph is the introduction of Biogen's First Quarter 2025 Earnings Call. The conference call begins with Melinda, the conference operator, welcoming participants and detailing the structure of the call, which includes remarks followed by a Q&A session. Tim Power, Head of Investor Relations, continues with a caution about forward-looking statements and directs listeners to relevant documents on Biogen's website. He introduces the speakers on the call, including Chris Viehbacher, CEO; Dr. Priya Singhal, Head of Development; and Robin Kramer, the new CFO. Chris Viehbacher then acknowledges Robin Kramer's first quarter as Biogen's CFO and describes Biogen's successful start to the year as "a tale of two companies."

The paragraph discusses Biogen's shift in focus from its declining MS portfolio to a new phase emphasizing its growing rare disease business, which now accounts for about 45% of its product revenue. The company highlights successful product launches, including global rollouts of ZURZUVAE, LEQEMBI, and VUMERITY, and approvals of LEQEMBI in Europe and SKYCLARYS in the UK and Brazil. Future growth is expected from its pipeline, with notable progress such as the FDA Fast Track designation for BIIB080 for Alzheimer's and the initiation of Phase 3 trials for felzartamab in AMR. Biogen is also actively pursuing external partnerships, like their collaboration with Stoke for zorevunersen in Dravet syndrome. The company demonstrates confidence in its financial stability and strategy for continued innovation, as evidenced by LEQEMBI's significant revenue generation, nearing $100 million, and its marketing authorization in the EU.

The paragraph discusses the significant regulatory approval of a new Alzheimer's drug, highlighting its importance as the first disease-modifying agent in the field. Despite challenges in its launch, innovations like IV maintenance and upcoming subcutaneous formulations aim to ease the treatment process by reducing dosage frequency and enabling at-home administration. Moreover, advancements in blood-based biomarker tests could simplify diagnosis, potentially replacing more invasive procedures. The drug, LEQEMBI, shows promise with several upcoming developments, and a new commercialization strategy has been initiated as of April 1.

The paragraph outlines the progress and strategic adjustments made by Biogen and its partner Eisai in their commercial approach, particularly highlighting developments with two products: ZURZUVAE and SKYCLARYS. For ZURZUVAE, which is used to treat postpartum depression (PPD), the company learned that OB-GYNs, rather than psychiatrists, play a crucial role in prescribing the medication. In Q1, 80% of prescriptions came from OB-GYNs, and there was a 20% increase in the number of physicians writing prescriptions. This increase in prescriptions, along with repeat prescriptions, is creating a positive cycle of greater attention to PPD. Additionally, Biogen expanded its field presence mid-quarter. SKYCLARYS achieved $124 million in worldwide sales, marking significant year-over-year and quarter-over-quarter growth, although there was some impact from the Inflation Reduction Act (IRA).

The paragraph discusses the growth and strategy of a company targeting a European-origin genetic disease prevalent where European explorers settled. The focus is on success in Europe due to centralized populations, while the U.S. requires more creative patient-finding methods. Techniques involve using social media and genealogy to identify patients, likened to "finding needles in haystacks." They report steady growth with approximately 2,400 patients undergoing therapy globally, across 26 markets, though not all are paying patients due to early access programs. The company's progress with their product, SKYCLARYS, is compared favorably to the launch of SPINRAZA, a successful rare disease treatment. Brazil is highlighted as a crucial market due to its patient population linked to European exploration.

The paragraph discusses the company's progress in diversifying its research and development focus beyond neuroscience, which was previously its sole concentration, to include immunology. While acknowledging the complexities and high costs associated with neuroscience research, the company emphasizes its continued commitment to it due to unmet needs. However, it also highlights the strategic addition of immunology, leveraging its foundational expertise, particularly in multiple sclerosis (MS). This diversification aims to provide balanced growth opportunities. The paragraph also mentions that immunology offers avenues for proof-of-concept studies, using felzartamab as a key example.

The paragraph discusses the progress and strategies surrounding Biogen's pharmaceutical pipeline, highlighting the confidence in Phase 3 clinical trials for felzartamab and the initiation of five new Phase 3 studies, which indicate pipeline maturation and increased development opportunities. It also notes anticipated data readouts by 2026, underscoring the company's growth and emergence. Additionally, it touches on the challenges posed by tariffs, emphasizing their complexity and the misperception of using Biogen's tax rate as an indicator of tariff exposure.

The paragraph discusses Biogen's financial and operational structure, highlighting that 75% of its 2024 U.S. product revenue comes from domestically manufactured products, with a significant portion exported. Additionally, about 55% of its product revenue is from outside the U.S., which is atypical for the industry. Despite potential tariff changes, Biogen's 2025 financial outlook remains stable due to robust supply chains and inventory management. The company is predominantly U.S.-based and proud of it. The text concludes with a transition to Priya Singhal, who will discuss advancements in R&D.

The article discusses a company's progress and future plans in its pharmaceutical pipeline, aiming for sustainable long-term growth driven by increased data flow. Key developments include the FDA's Fast Track designation for BIIB080, an Alzheimer's treatment targeting tau, supported by promising Phase 1b results. The company also initiated a Phase 3 study of felzartamab for AMR, with further studies for IgAN and PMN expected this year. Additionally, they have expanded their rare disease pipeline by acquiring rights to zorevunersen, potentially the first treatment to address the underlying cause of Dravet syndrome outside the U.S., Canada, and Mexico.

The paragraph discusses positive Phase 1/2a data for zorevunersen, highlighting improvements in cognition and behavior for Dravet syndrome, and the upcoming Phase 3 EMPEROR study. It also covers advancements in Alzheimer's treatment, focusing on the progress of LEQEMBI, including its approval in Europe and development of a subcutaneous formulation for convenience. The paragraph emphasizes the importance of real-world data in treating symptomatic early Alzheimer's patients and the potential role of blood-based diagnostics. Additionally, it underscores the significance of the AHEAD 3-45 study in exploring LEQEMBI's benefits in presymptomatic Alzheimer's patients.

The paragraph discusses progress in Alzheimer's disease treatment, highlighting the development of therapies like BIIB080 and advancements in the pre-proof-of-concept pipeline. Significant achievements include completing enrollment in a Phase 2 study for a LRRK2 inhibitor for Parkinson's disease with Denali. The strategy focuses on a disciplined, data-driven approach to pipeline development, incorporating both internal and external innovations. The paragraph then transitions to a financial update by Robin Kramer, the newly-appointed CFO, who expresses gratitude and outlines plans to discuss first-quarter financial results.

In the first quarter, total revenue reached $2.4 billion, a 6% increase from the previous year, driven partly by SPINRAZA and partner revenue shipments. The company's four newly launched products generated about $200 million, growing 22% quarter-over-quarter and more than doubling year-over-year. However, non-GAAP diluted EPS fell 18% to $3.02, influenced by a $165 million upfront payment for the Stoke transaction, which impacted EPS by approximately $0.95. Excluding this, EPS would have been $3.97, an 8% annual increase. The company generated $222 million in free cash flow, including the Stoke payment, ending the quarter with $2.6 billion in cash. Their MS franchise saw an 11% revenue decline due to competition, including TYSABRI biosimilars in Europe and TECFIDERA generics globally. VUMERITY demand increased, maintaining its position as the top branded oral therapy. SPINRAZA experienced a 4% year-over-year demand increase in the U.S., with international revenue benefiting from a VAT refund and shipment timing, adding roughly $26 million compared to a year before.

In the first quarter, Biogen's four launch products generated $200 million in revenue, reflecting a 22% increase from the previous quarter and more than doubled compared to the previous year. This growth includes LEQEMBI's end market sales of $96 million and SKYCLARYS' global revenue of $124 million, helped by its expansion outside the U.S. U.S. revenue for SKYCLARYS reached $69 million, though Medicare discounts impacted this figure. Both ZURZUVAE and QALSODY have seen sequential growth in demand. Corporate partner revenue rose due to the timing of batch commitments in contract manufacturing, with expectations for consistent partner revenue comparison between 2024 and 2025. Planned maintenance may result in minimal corporate partner revenue in Q4. Non-GAAP cost of sales was affected by lower-margin manufacturing revenue, while operating expenses benefited from R&D prioritization, despite increased spending on product launches and development. Operating income included $201 million in R&D charges, with a significant upfront payment linked to the Stoke transaction impacting EPS by $0.95.

The company reports a non-GAAP operating income of $748 million, a 7% increase year-over-year, excluding a $165 million upfront payment. They will now separately report acquired in-process R&D and milestone charges for better transparency. A $222 million free cash flow was generated in the first quarter, considering a payment to Stoke, ending with $2.6 billion in cash and $3.7 billion in net debt. The strong balance sheet supports growth opportunities. The full-year EPS guidance has been updated, factoring in a $0.95 impact from the Stoke transaction and a $0.20 tailwind from foreign exchange. The 2025 non-GAAP EPS is expected to be $14.50-$15.50. Total revenue for 2025 is expected to decline due to a decrease in the MS business, despite growth from launch products.

The paragraph discusses Biogen's expectations and guidance for the near future. The company anticipates a biosimilar for TYSABRI in the U.S. in Q4 and acknowledges the impact of generic TECFIDERA in Europe. They aim to achieve $1 billion in gross savings and $800 million in net savings through their Fit for Growth initiative. Corporate partner revenue is expected to remain consistent from 2024 to 2025, with minimal revenue in Q4 due to maintenance and batch timing. Biogen does not expect significant tariff impacts in 2025 due to its U.S.-based manufacturing operations and current inventory levels, although the global tariff landscape is uncertain. Lastly, the tax rate is influenced by business mix and isn't indicative of potential tariff impacts.

The paragraph discusses Biogen's tax strategy, with most U.S. market revenues being taxable in the U.S., and non-U.S. revenues subject to both local taxes and the U.S. GILTI regime. It highlights Biogen's focus on adapting to evolving tariff landscapes. Chris Viehbacher then emphasizes Biogen's growth strategy, mentioning several upcoming Phase 3 trials, clinical trial readouts, regulatory decisions, and the company's restructuring efforts in research to focus more on pre-clinical collaborations. He also mentions Biogen's reputation for developing first-in-class, disease-modifying medicines targeting difficult diseases, like antibody-mediated rejection (AMR), and emphasizes the need to explore these areas in-depth to understand Biogen's competitive advantage and patient journey.

The paragraph discusses the challenges and opportunities related to advancing treatments for diseases like AMR (antimicrobial resistance) and IgAN (IgA nephropathy). It highlights the promising results Biogen has seen with AMR in Phase 2 trials and the interest in IgAN and felzartamab research. It announces educational seminars starting from June 11, where internal experts will discuss these areas in depth. The paragraph then transitions to a Q&A session, with Brian Abrahams from RBC Capital Markets asking about the rollout strategy for Biogen's drug LEQEMBI, recently approved in Europe. Chris Viehbacher responds, noting that the rollout and reimbursement process will be gradual as LEQEMBI represents a new class of budgetary expenses for healthcare systems.

The paragraph discusses the strategy for launching LEQEMBI, a product for an aging market in Europe, which faces various challenges and opportunities due to thorough evaluations by European Union countries. The product's efficacy, safety, and economic benefits have been scrutinized, which could aid in reimbursement processes. The conversation then shifts to the potential of a subcutaneous formulation of LEQEMBI for at-home administration in the United States, which could enhance sales by offering more convenient options for patients who have been receiving bi-weekly infusions for 18 months. The focus is on ensuring physicians and patients understand the benefits of continuing the therapy.

The paragraph discusses the advantages of transitioning from infusion-based treatments to subcutaneous administration for long-term chronic therapy, particularly for older patients. It highlights that after 36 months, patients show better outcomes with continued treatment. The convenience of subcutaneous administration is emphasized, as it allows at-home treatment, reducing the need for infusions, easing physician workloads, and being more accessible for patients in rural areas. The paragraph also notes that in urban centers, initial treatment may still involve infusions for monitoring purposes, before transitioning to subcutaneous administration.

Chris Viehbacher discusses the potential for LEQEMBI's growth, focusing on the need for early Alzheimer's diagnosis and treatment. He highlights the challenges in diagnosing Alzheimer's, as it often takes years for primary care physicians to differentiate it from normal aging or other dementias. Viehbacher emphasizes the importance of early treatment to prevent neuronal damage, citing recent data that shows promising results for early-stage patients undergoing treatment. He mentions that while there is limited information about the diagnostic tools like Fujirebio's in vitro diagnostic, establishing effective diagnostics is critical for earlier intervention and improved patient outcomes.

The paragraph discusses the competition between LEQEMBI and Lilly's Kisunla in the market, particularly focusing on their commercial positioning regarding finite dosing. Chris Viehbacher highlights that although the official launch of their product, LEQEMBI, was considered to be in September 2023 due to full approval and reimbursement clearance, there's still ongoing education needed. He notes that some physicians believe treatment can cease once plaques are removed, but emerging data suggests the importance of continued therapy to prevent plaque return and damage. There's a recognition of varying physician perspectives and the need for further education on the benefits of ongoing treatment.

The paragraph discusses the decision-making process for patients and physicians regarding the use of donanemab, a treatment option whose suitability depends on factors like the patient's age, fragility, and geographical location. It mentions that the market for these treatments could be divided between competitors, with a shared goal of expanding patient access to disease-modifying treatments. Despite some adoption, only a small fraction of patients in need are currently receiving treatment. Chris Schott from JPMorgan inquires about Biogen's business development strategies amid market volatility, and Chris Viehbacher responds, noting recent shifts in investor focus and valuation challenges, with healthcare investors under pressure to find liquidity.

The article discusses the current business environment, highlighting that many companies are hesitant to take action due to low valuations and difficulties in securing financing. However, this presents opportunities for acquisitions and collaborations, especially as some funding sources, like venture capital, dry up. Biogen is noted as being well-positioned in this climate, with a strong West Coast Hub and expertise in collaborations. The paragraph ends with a transition to a Q&A session where Michael Yee from Jefferies asks about the early AHEAD 3-45 study, noting a projected 2028 readout while competitors may have an earlier timeline.

The paragraph discusses the positioning and anticipated outcomes of the AHEAD 3-45 study for LEQEMBI in presymptomatic Alzheimer's disease. Priya Singhal highlights that the study aims to understand how LEQEMBI can preserve cognition across the full spectrum of presymptomatic Alzheimer's by conducting two parallel trials. AHEAD 3 focuses on subjects with 20 to 40 centiloids of amyloid to evaluate if amyloid accumulation can be stopped, using amyloid PET as the primary endpoint. AHEAD 45, on the other hand, includes subjects with greater than 40 centiloids, aiming to prevent cognitive decline with endpoints like the PAC-5 and amyloid and tau PET. This is contrasted with TRAILBLAZER-ALZ 3, which evaluates donanemab's effect on slowing clinical progression in a mixed population of symptomatic and presymptomatic patients. The AHEAD 3-45 study is expected to be fully enrolled and provide a readout by 2028.

The paragraph discusses the importance of the AHEAD study in determining treatment strategies for presymptomatic patients with amyloid presence, focusing on the risk-benefit equation of early treatment in Alzheimer's. Chris Viehbacher emphasizes the challenges in assessing the level of amyloid burden using blood-based diagnostics and the necessity of more comprehensive studies, like AHEAD 3 and 45, to guide physician decisions. The dialogue then shifts to a question from Mike DiFiore regarding the sales performance of Lilly's drug compared to LEQEMBI and whether Biogen and Eisai have facilitated the healthcare infrastructure for Lilly's benefit.

In the paragraph, Chris Viehbacher discusses the competitive dynamics between lecanemab and donanemab, noting that the focus is on which treatment to initiate rather than switching between the two. He emphasizes the importance of expanding the market by increasing treatment centers and education rather than competing for market share in the still small market. Then, Terence Flynn from Morgan Stanley asks about interactions with the FDA under the new administration, particularly regarding the Dravet program moving into Phase 3 and potential changes in the FDA's approach to rare diseases, surrogate endpoints, and industry favorability. Priya Singhal acknowledges the question and thanks him.

The paragraph discusses the progress of Biogen’s engagement with drug regulatory bodies regarding their treatment for Dravet syndrome. Despite the complexity of the condition and the high seizure burden in patients, Biogen’s trial of zorevunersen has shown promising results, with an 87% reduction in seizures on top of the standard of care. The data was collected from a small open-label trial but demonstrated durability over six months. Biogen has coordinated with regulatory authorities in the FDA, Europe, and Japan and agreed on the design for the Phase 3 EMPEROR’s trial. The company is confident that their approach will effectively assess the treatment’s potential as a disease-modifying therapy. Additionally, Biogen hasn’t experienced delays in FDA interactions.

The paragraph discusses recent changes at the FDA under the new commissioner, Makary, highlighting his focus on innovative processes, such as using surrogate markers and reducing animal studies, alongside AI adoption. Despite some leadership changes and staff reductions at the FDA, Biogen hasn't experienced any negative impacts and anticipates potential benefits from new perspectives. In a question from Citibank's Geoff Meacham, Biogen's manufacturing capacity in the U.S., especially in relation to Alzheimer's expectations and potential partnerships due to excess capacity, is addressed. Chris Viehbacher notes Biogen's engagement with contract development and manufacturing organizations at its Solothurn facility and third-party manufacturing at its efficient and reputable RTP site.

The paragraph concludes a conference discussion where Robin Kramer and Tim Power express their openness to new opportunities and highlight their balanced manufacturing operations for both their own products and those of their partners. Tim Power thanks the participants and invites them to contact the Investor Relations team for further questions, after which the operator concludes the conference.

This summary was generated with AI and may contain some inaccuracies.