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Financial Data and Key Metrics Changes - Total revenue for Q2 2023 was $2.5 billion, a decrease of 5% at actual currency and 3% at constant currency compared to Q2 2022 [24] - Non-GAAP diluted earnings per share for Q2 2023 was $4.02 [24] - Total MS Products revenue was $1.2 billion, a decrease of 15% at actual currency and 14% at constant currency [24] Business Line Data and Key Metrics Changes - SPINRAZA revenue was $437 million, an increase of 1% at actual currency and 5% at constant currency, with US growth driven by patient growth [26] - Biosimilars revenue was $195 million, flat at actual currency and increased 4% at constant currency [27] - Alzheimer's disease revenue, including ADUHELM and LEQEMBI collaboration, resulted in a $20 million headwind to revenue during Q2 2023 [27] Market Data and Key Metrics Changes - The decline in MS revenue was attributed to generic entrants for TECFIDERA and broad competition in the MS market [24] - TECFIDERA's regulatory market protection in the EU was extended by one additional year until February 2, 2025 [25] - TYSABRI biosimilar launch is anticipated in the US and EU later in 2023 [25] Company Strategy and Development Direction - The company is focused on external growth opportunities in rare diseases, immunology, and neuropsychiatry [14] - A comprehensive review of R&D programs has been conducted to prioritize high-value projects and improve productivity [21] - The company aims to achieve $1 billion in annualized gross cost savings, with at least $300 million expected to be reinvested in growth opportunities [14] Management's Comments on Operating Environment and Future Outlook - Management views the approval of LEQEMBI as a historic moment in healthcare, marking the first disease-modifying treatment for Alzheimer's [5] - The company anticipates a gradual uptake of LEQEMBI due to the complexity of the treatment process and the need for physician education [51] - Management reaffirmed full-year 2023 revenue guidance of a mid-single-digit percentage decline compared to 2022 [32] Other Important Information - The company ended Q2 2023 with $7.3 billion in cash and marketable securities, and $6.3 billion in debt, resulting in a net cash position of approximately $1 billion [32] - The fit-for-growth initiative includes a significant reduction in centralized functions and a net headcount reduction of approximately 1,000 [31] Q&A Session Summary Question: What are the most important learnings regarding beta-amyloid class efficacy and safety profiles? - Management highlighted the complexity of the competitive landscape, noting differences in product mechanisms and patient populations studied [38][40] Question: Can you provide clarity on the cost savings and expectations for SG&A and R&D? - Management confirmed that savings will be a mix from both SG&A and R&D, with a slight bias towards SG&A [46] Question: How is the fit-for-growth initiative influencing thoughts on M&A and business development? - Management indicated that the initiative allows for a more strategic approach to external growth, focusing on building a robust portfolio in neuroscience and rare diseases [62][66]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ☒ ACT OF 1934 For the quarterly period ended June 30, 2023 OR TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ☐ ACT OF 1934 Commission File Number 0-19311 BIOGEN INC. (Exact name of registrant as specified in its charter) Delaware 33-0112644 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Ide ...

First Quarter 2023 Financial Results and Business Update Non-GAAP financial information This presentation and the discussions during this conference call include certain financial measures that were not prepared in accordance with accounting principles generallyaccepted in the U.S. (GAAP), including adjusted net income, adjusted diluted earnings per share, revenue growth at constant currency, which excludes the impact of changes in foreign exchange rates and hedging gains or losses, and free cash flow, whic ...

Biogen Inc. (NASDAQ:BIIB) Q1 2023 Earnings Conference Call April 25, 2023 8:00 AM ET Company Participants Chuck Triano - Head of Investor Relations Christopher Viehbacher - President and Chief Executive Officer Priya Singhal - Head of Development and Interim Head of Research and Global Safety and Regulatory Sciences Michael McDonnell - Chief Financial Officer Conference Call Participants Phil Nadeau - TD Cowen Paul Matteis - Stifel Geoff Meacham - Bank of America Salveen Richter - Goldman Sachs Umer Raffat ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ☒ ACT OF 1934 For the quarterly period ended March 31, 2023 OR TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ☐ ACT OF 1934 Commission File Number 0-19311 BIOGEN INC. (Exact name of registrant as specified in its charter) Delaware 33-0112644 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Id ...

Summary of Biogen Inc. Conference Call Company Overview - **Company**: Biogen Inc. (NASDAQ:BIIB) - **Event**: 43rd Annual Cowen Healthcare Conference Call - **Date**: March 6, 2023 Key Points Current State and Future Direction - Biogen is transitioning from a strong focus on multiple sclerosis (MS) to broader therapeutic areas, with two significant product launches anticipated in 2023 [3][4] - The company is preparing for these launches, which include zuranolone and LEQEMBI, and is exploring direct-to-consumer advertising strategies [4] Financial Performance and Cost Management - Biogen reported a $5 billion profit decline compared to 2019, indicating a need to align its cost structure with industry best practices [4] - The company is benchmarking its operational expenses (OpEx) against peers, aiming to optimize spending on SG&A and R&D [6][7] - A focus on evaluating the R&D pipeline rigorously to ensure investments are made in products with a higher likelihood of market success [8][11] R&D Portfolio Strategy - Current R&D spending is over 30%, significantly higher than peers at around 20%, prompting a reassessment of the R&D portfolio [11] - Biogen aims to balance high-risk projects with more predictable, lower-risk investments to stabilize revenue streams [12][13] Business Development and M&A Strategy - The CEO indicated openness to business development opportunities, particularly in rare diseases, but emphasized the need for strategic and financially sound deals [16][17] - There is no immediate plan for acquisitions, but the company is not ruling out potential opportunities [17] Product Launch Strategies - **LEQEMBI**: Anticipated challenges include the complexity of diagnosing Alzheimer's and the need for increased capacity in healthcare settings to manage patient influx [24][25] - The company is exploring blood diagnostics to streamline the diagnostic process and potentially reduce reliance on more invasive procedures [26] - **Zuranolone**: Positioned as a rapid-acting treatment for mental health conditions, with a unique marketing strategy focusing on short-term therapy [39][40] Long-term Sales Potential - Biogen is optimistic about LEQEMBI's long-term sales potential, with projections of $2.5 billion in sales by 2027, indicating confidence in the product's market penetration [33][34] Biosimilars Business - The biosimilars segment is viewed as important for maintaining competitiveness in the market, although it presents challenges due to high development costs and pricing pressures [47][48] Multiple Sclerosis Outlook - Biogen acknowledges the competitive landscape for MS treatments, particularly with the rise of biosimilars and generics, while continuing to invest in R&D for innovative solutions [50][51] Additional Insights - The CEO emphasized the importance of understanding unmet medical needs and managing risks in product development, moving away from rigid financial models like net present value [19][20][21] - The company is committed to addressing the needs of disadvantaged populations in Alzheimer's treatment, ensuring equitable access to new therapies [31][32]

Biogen Inc. (NASDAQ:BIIB) Q4 2022 Results Conference Call February 15, 2023 8:00 AM ET Company Participants Mike Hencke - Head, Investor Relations Christopher Viehbacher - CEO Michael McDonnell - Chief Financial Officer Priya Singhal - Interim Head, Research & Development Conference Call Participants Salveen Richter - Goldman Sachs Mohit Bansal - Wells Fargo Colin Bristow - UBS Umer Raffat - Evercore Evan Seigerman - BMO Tim Anderson - Wolfe Research Brian Abrahams - RBC Capital Markets Michael Yee - Jeffer ...

Revenue and Product Sales - TECFIDERA, TYSABRI, and SPINRAZA each accounted for more than 10.0% of total revenue for the years ended December 31, 2022, 2021, and 2020[62]. - Product sales to two wholesale distributors accounted for approximately 37.9%, 38.9%, and 45.8% of gross product revenue for the years ended December 31, 2022, 2021, and 2020, respectively[84]. - A significant portion of revenue is concentrated on sales of existing products, which face increasing competition from generics and biosimilars[242]. - Sales of TECFIDERA declined significantly due to multiple generic entrants in the U.S. market in 2020[251]. Product Launches and Approvals - BYOOVIZ launched in the U.S. in June 2022 and became commercially available during the third quarter of 2022[69]. - LUNSUMIO received accelerated approval in the U.S. during the fourth quarter of 2022[73]. - LEQEMBI is in the early stages of commercial launch in the U.S., with potential risks related to FDA approval compliance[243]. Collaborations and Partnerships - The company collaborates with Eisai for the distribution of Alzheimer's disease products in the U.S.[68]. - The company has a collaboration agreement with Eisai for the joint development and commercialization of LEQEMBI, sharing all costs equally[128]. - The company has a global collaboration with Sage Therapeutics for the development of zuranolone, sharing equal responsibility and costs for development and profits in the U.S.[131]. - The company has an exclusive collaboration agreement with Ionis Pharmaceuticals for the development of antisense therapeutics for neurological diseases, including SPINRAZA for spinal muscular atrophy[132]. - The company has a collaboration agreement with Denali Therapeutics to co-develop small molecule inhibitors of LRRK2 for Parkinson's disease, sharing costs and profits based on specified percentages[135]. - The collaboration with Sangamo Therapeutics includes the development of ST-501 for tauopathies and ST-502 for synucleinopathies, with potential tiered royalties on net sales in the high single digits to sub-teen percentages[143]. - The company has a joint venture with Samsung BioLogics to develop and market biosimilar products, including three anti-TNF biosimilar candidates over a 10-year term[137]. - The company has a collaboration agreement with UCB to jointly develop dapirolizumab pegol for SLE, sharing costs and profits equally[142]. Competition and Market Challenges - The company faces intense competition in the biopharmaceutical industry, with competitors having greater financial and research resources[99]. - The introduction of generic versions and biosimilars is expected to significantly reduce the prices and volumes of the company's products, negatively impacting revenue[104]. - TECFIDERA revenue has significantly declined due to generic competition, and the company expects this trend to continue in the future[107]. - Competition in the MS market is intense, with OCREVUS gaining market share since its approval in the U.S. in 2017 and in the E.U. in 2018[110]. - The competitive landscape is influenced by the speed of product development and approval processes, which can significantly affect market share[101]. - The company is aware of other products in development that may compete with its existing therapies, potentially affecting future sales[111]. - Competition from current and future competitors may negatively impact the company's ability to maintain pricing and market share[260]. - The company faces pressure from employers on private health insurance plans to reduce costs, affecting revenue[260]. Regulatory and Compliance - Regulatory exclusivity provides a set period of time for exclusive use of proprietary data, which varies by country and can significantly impact product commercialization[88]. - The company is subject to substantial government regulation regarding product approval and post-approval processes, which can significantly impact timelines and costs[146]. - The company must adhere to Good Manufacturing Practices (cGMP) and may face significant financial penalties if found non-compliant during inspections by regulatory agencies[165]. - The company is required to report average manufacturer price (AMP) and best price quarterly, with complex calculations that could affect rebate liabilities[174]. - Under the U.S. Orphan Drug Act, the company can receive seven years of market exclusivity for drugs with orphan designation after initial FDA approval[171]. - The Inflation Reduction Act (IRA) may lead to a material adverse effect on the company's revenue for drugs subject to price negotiation starting in 2026[177]. - The company faces potential new rebate liabilities for drugs whose prices increase faster than inflation, starting in 2022 for Medicare Part D[176]. - The company is obligated to inform regulatory agencies of any new information that may affect the evaluation of benefits and risks of its medicinal products[163]. - The company may face civil, criminal, or administrative sanctions if found non-compliant with pharmacovigilance obligations in the E.U.[162]. Research and Development - The company is committed to significant resources for research and development, focusing on unmet medical needs and differentiated drug candidates[120]. - The company seeks patent protection in the U.S. and selected countries for inventions from its research and development efforts[85]. - The company continues to pursue additional patents and extensions to enhance product exclusivity beyond current expiration dates[91]. - The company has secured exclusive rights to commercialize BYOOVIZ, a ranibizumab biosimilar, which was approved in the U.S., E.U., and U.K. in Q3 2021, and launched in the U.S. in June 2022[138]. Manufacturing and Facilities - The company plans to build a new gene therapy manufacturing facility in RTP, NC, with an estimated total investment of approximately $195.0 million, expected to be operational by the end of 2023[189]. - The company’s manufacturing facilities include a drug substance manufacturing facility in RTP, NC, and a facility in Solothurn, Switzerland, approved for the manufacture of ADUHELM and LEQEMBI by the FDA[190][193]. - The company’s second manufacturing suite at the Solothurn facility is expected to be operational by the end of 2023[193]. - The company has initiated a technology transfer for VUMERITY, with an increased royalty rate to Alkermes on future worldwide net commercial sales[194]. Environmental, Social, and Governance (ESG) - The company has committed to matching 100% of its electricity usage with renewable energy, credits, and offsets since 2014[198]. - The company’s environmental, social, and governance (ESG) efforts prioritize climate, health, and equity, with a focus on vulnerable populations[197]. - Biogen scored 100% on the Disability:IN's Disability Equality Index for the fifth consecutive year, indicating strong commitment to disability inclusion[209]. - In 2022, Biogen introduced GlobeSmart®, a tool aimed at enhancing cross-cultural collaboration and increasing cultural agility among global teams[211]. - The company conducted a global gender pay assessment in 2022, analyzing pay equity at executive, management, and other professional levels[213]. - Biogen's commitment to pay equity includes regular reviews of compensation practices to ensure equitable pay decisions across the workforce[212]. Employee and Workplace Culture - The company has approximately 8,725 employees worldwide as of December 31, 2022, with about 4,970 employees in the U.S. and 3,755 employees in foreign countries[206]. - Biogen offers over 1,200 instructor-based courses through Biogen University, with approximately 300 available virtually, and access to more than 20,000 on-demand learning modules via LinkedIn Learning[216]. - The company has refreshed flexible working arrangement policies to better support work-life balance for employees[218]. - Biogen's employee survey program allows for anonymous feedback, enabling managers to improve workplace culture and engagement[219]. - In 2022, Biogen implemented significant progress in integrating Human Performance into its Environment, Health and Safety programs, focusing on proactive problem-solving and risk management[224]. - The company actively manages succession planning to ensure long-term continuity, reviewing talent development for critical roles annually[222].