Core Insights - The Phase 3 PHOENYCS GO study results indicate that dapirolizumab pegol (DZP) shows significant clinical improvements in disease activity for patients with moderate-to-severe systemic lupus erythematosus (SLE) [1][4][6] - The study demonstrated improvements in fatigue and disease activity measures, suggesting DZP's potential as a new treatment option for SLE [2][3][5] Company Overview - UCB is a global biopharmaceutical company focused on innovative medicines for severe diseases of the immune system and central nervous system, generating €6.1 billion in revenue in 2024 [13] - Biogen is a leading biotechnology company that develops innovative therapies, leveraging deep biological understanding to create new medicines [14] Clinical Study Findings - At Week 48, 40.9% of participants receiving DZP achieved low disease activity compared to 19.6% in the standard of care (SOC) group, with significant differences noted as early as Week 12 [6][7] - Improvements in fatigue were quantified, with the DZP group showing a change from baseline of 8.9 in FACIT-Fatigue scores versus 5.2 in SOC alone [5] - The safety profile of DZP was generally favorable, with treatment-emergent adverse events (TEAEs) occurring in 82.6% of DZP participants compared to 75.0% in SOC [8] Future Developments - A second Phase 3 trial, PHOENYCS FLY, is ongoing to further confirm the efficacy and safety of dapirolizumab pegol in SLE [9]

Summary of Biogen Thematic Pipeline Seminar on Rare Kidney Disease Company and Industry Overview - **Company**: Biogen - **Industry**: Rare Kidney Disease and Nephrology Core Points and Arguments 1. **Focus on Falzartamab**: The seminar centers on Biogen's drug falzartamab and its potential across multiple nephrology indications, particularly in rare kidney diseases [3][4] 2. **Restructuring for Growth**: Biogen has restructured its business through the "fit for growth" program, leading to the launch of four disease-modifying treatments in the past two years, which now contribute significantly to total revenue [5][6] 3. **Pipeline Diversification**: The company has critically reviewed its development assets, resulting in a more diversified and promising pipeline, particularly in immunology and nephrology [6][7] 4. **Immunology Expansion**: The acquisition of Hibio has accelerated Biogen's expansion into immunology, with three phase three studies in rare nephrology indications currently being initiated [7][8] 5. **Unique Mechanism of Action**: Falzartamab targets CD38, which is believed to be effective in treating antibody-mediated diseases by depleting cells that produce autoantibodies, potentially offering a differentiated safety profile [15][16] 6. **Clinical Data for AMR**: In a phase two study for antibody-mediated rejection (AMR), over 80% of patients showed resolution of AMR features on biopsy, compared to 20% in the placebo group, indicating falzartamab's potential as a breakthrough therapy [27][28] 7. **High Unmet Need in AMR**: AMR is a leading cause of kidney transplant failure, with no approved treatments currently available, highlighting the significant opportunity for falzartamab [21][22] 8. **Cost Implications**: The cost to treat AMR is approximately $160,000 per year, emphasizing the economic burden and the need for effective therapies [23] 9. **Phase Three Study for AMR**: The TRANSCEND phase three study will enroll around 120 kidney transplant recipients with late AMR, with results expected in 2027 [30][31] 10. **IgA Nephropathy (IGAN)**: IGAN is the most common type of primary glomerulonephritis, and falzartamab has shown promise in reducing proteinuria and maintaining kidney function over time [53][60] 11. **Phase Three Study for IGAN**: The PREVAIL phase three study is underway, with data expected in 2029, focusing on the change in proteinuria and eGFR [61][62] 12. **Primary Membranous Nephropathy (PMN)**: PMN is characterized by severe antibody-mediated disease with no approved treatments, and falzartamab has shown robust reductions in anti-PLA2R antibodies in clinical studies [83][89] 13. **Phase Three Study for PMN**: The PROMINENT phase three study is set to confirm the efficacy of falzartamab in moderate to high-risk patients with PMN, with results expected in 2029 [90][91] Other Important but Possibly Overlooked Content 1. **Commercial Potential**: Each of the three indications (AMR, IGAN, PMN) presents significant commercial potential, despite varying patient populations and market sizes [110][111] 2. **Chronic Dosing Considerations**: The potential for chronic dosing in AMR and the need for ongoing treatment in PMN and IGAN are critical factors in the commercialization strategy [111][112] 3. **Future Opportunities**: Biogen is exploring additional indications for falzartamab, including lupus nephritis, with a phase one study expected to provide data by 2026 [114][115] This summary encapsulates the key points discussed during the Biogen thematic pipeline seminar, focusing on the company's strategic direction, clinical advancements, and the potential impact of falzartamab in treating rare kidney diseases.

Biogen Inc. (NASDAQ:BIIB) Goldman Sachs 46th Annual Global Healthcare Conference June 10, 2025 10:40 AM ET Company Participants Robin C. Kramer - Executive VP & CFO Conference Call Participants Salveen Jaswal Richter - Goldman Sachs Group, Inc., Research Division Salveen Jaswal Richter Great. Good morning, everyone. Thank you so much for joining us. I'm Salveen Richter, biotechnology analyst at Goldman Sachs and really pleased to have with us Robin Kramer, CFO of Biogen. Question-and-Answer Session Salveen ...

Financial Data and Key Metrics Changes - The company is executing a Fit for Growth program aimed at optimizing its cost structure, with a target of achieving $800 million in net cost savings by the end of the year [44] - The company has successfully executed activities necessary to yield $1 billion in growth and $800 million in net savings [44] Business Line Data and Key Metrics Changes - The company has shifted its focus from primarily neuroscience to include immunology and nephrology, with significant investments in four ongoing product launches [4][9] - The company has nine programs in phase three or phase three ready, indicating a robust pipeline for future growth [7] Market Data and Key Metrics Changes - The U.S. launch of Skyclaris is in a steady growth phase, while initial launches in Europe are progressing similarly [48] - The company has received approval in Brazil for Skyclaris, which is expected to be an important market [49] Company Strategy and Development Direction - The company is focused on redeploying capital from its MS business to support new growth opportunities in nephrology and immunology [5] - The company is actively pursuing business development opportunities, including the acquisition of Hai Bio, to enhance its pipeline [7][8] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the foundational position of the company for future capital deployment and growth opportunities [6] - The company is monitoring potential changes in drug pricing policies and tariffs, which could impact negotiations in the EU [14][15] Other Important Information - The company is excited about the potential of its pipeline assets, particularly in rare diseases and kidney diseases, as highlighted in an upcoming investor presentation [40][41] - The company is leveraging AI technology to identify patients for its therapies, indicating a focus on innovative approaches in patient engagement [49] Q&A Session Summary Question: How is the firm balanced now in terms of various disease areas? - The company is leveraging existing expertise in rare diseases while expanding into nephrology and immunology through strategic acquisitions [10] Question: What is the comfort level among PCP providers with the use of blood-based biomarker tests for Alzheimer's? - PCP providers are already using blood-based biomarkers alongside PET scans, indicating a growing acceptance of these tests [26] Question: What are the expectations for the upcoming readouts from the company's trials? - The company anticipates steady progression in growth and is optimistic about the potential for inflection points with new diagnostic tests and treatment methods [27]

Core Insights - Biogen and City Therapeutics have announced a strategic collaboration to develop novel RNA interference (RNAi) therapies, combining Biogen's drug development expertise with City Therapeutics' RNAi engineering technologies [1][2][3] - The collaboration will initially focus on a target related to central nervous system diseases, utilizing advanced drug delivery technologies for systemic administration [2][3] - City Therapeutics will receive $46 million, including a $16 million upfront payment and a $30 million investment, with potential milestone payments of up to $1 billion based on development success [3] Company Overview - Biogen is a leading biotechnology company founded in 1978, focused on innovative science to deliver new medicines and create shareholder value [4] - City Therapeutics is a biopharmaceutical company specializing in next-generation RNAi technologies, aiming to expand the therapeutic reach of RNAi-based medicines [6]

Last week, I took a closer look at outside days on a candlestick chart of the S&P 500 Index (SPX). As a refresher, an outside day occurs when a stock’s daily high is higher than the prior day’s high, and its low is lower than the prior day's low. Essentially, it engulfs the prior day's range. In that article, I broke down when outside days tend to be more meaningful instead of just noise. This week, I’m applying the same analysis to individual stocks within the S&P 500. By the end, I find a setup that stand ...

Core Insights - Jeito Capital has promoted Mehdi Ainouche to Partner and Julien Elric to Senior Principal, reflecting the firm's growth and commitment to internal talent development [1][6] Group 1: Promotions and Roles - Mehdi Ainouche joined Jeito in 2020 and has played a crucial role in the investment cycle, particularly with the successful sale of EyeBio to Merck & Co for up to $3 billion [2][3] - Julien Elric joined Jeito in 2021 and has been instrumental in financing and clinical development strategies, notably contributing to the investment and exit of HI-Bio acquired by Biogen Inc. for up to $1.8 billion [4][5] Group 2: Company Overview - Jeito Capital is a leading global Private Equity fund focused on biopharma, dedicated to financing and accelerating medical innovations with a patient benefit-driven approach [7] - The firm has built a diversified portfolio of clinical biopharmas addressing high unmet medical needs, with a presence in Europe and the United States [7]

Company Overview - Jeito Capital is a leading independent Private Equity fund focused on biopharma, dedicated to financing and accelerating the development of groundbreaking medical innovations [7] - The firm has a diversified portfolio of clinical biopharmas that address high unmet medical needs, with a strong presence in Europe and the United States [7] Promotions and Team Development - Mehdi Ainouche has been promoted to Partner, and Julien Elric to Senior Principal, reflecting Jeito's commitment to talent development and internal career progression [1][6] - Mehdi joined Jeito in 2020 and has played a crucial role in the investment cycle, particularly noted for the successful sale of EyeBio to Merck & Co for up to $3 billion [2] - Julien joined Jeito in 2021 and has been instrumental in financing and clinical development strategies, contributing to the investment and exit of HI-Bio™ acquired by Biogen Inc. for up to $1.8 billion [4] Leadership Insights - Dr. Rafaèle Tordjman, Founder and CEO of Jeito Capital, expressed delight in the promotions, highlighting the significant contributions of Mehdi and Julien to the firm's mission of unlocking the potential of portfolio companies [6]

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, 2025 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) (State or other jurisdiction of incorporation or organization) Delaware 33-0112644 (I.R.S. Employer Id ...

Core Viewpoint - Biogen reported first-quarter 2025 adjusted earnings per share (EPS) of $3.02, missing the Zacks Consensus Estimate of $3.32, with an 18% year-over-year decline in earnings due to a $165 million upfront payment to Stoke Therapeutics for a collaboration agreement [1][2][19] Financial Performance - Total revenues for Q1 2025 were $2.43 billion, reflecting a 6% year-over-year increase on a reported basis and an 8% increase on a constant-currency basis, surpassing the Zacks Consensus Estimate of $2.23 billion [2] - Total product sales reached $1.73 billion, up 1% year over year on a reported basis and 3% on a constant-currency basis [4] - Contract manufacturing and royalty revenues surged 61% year over year to $293 million, while Alzheimer's collaboration revenues increased to $33 million from $3 million in the prior year [5][6] Product Sales Breakdown - Multiple sclerosis (MS) revenues totaled $953 million, down 11% on a reported basis due to generic competition for Tecfidera [9] - Sales of Spinraza rose 24.2% to $423.9 million, exceeding the Zacks Consensus Estimate of $365 million [12] - New drug Qalsody for ALS recorded sales of $15.5 million, while Zurzuvae for postpartum depression generated $28 million in sales, reflecting a 21.7% sequential increase [13][14] Cost and Guidance - Adjusted R&D expenses decreased 3% year over year to $427 million, while adjusted SG&A expenses rose 1% to $572 million [16] - The company reaffirmed its total revenue guidance for 2025, expecting a mid-single-digit percentage decline in constant currency terms compared to 2024, and lowered its adjusted EPS guidance to a range of $14.50 to $15.50 [18][19] Market Performance - Year to date, Biogen's shares have declined 20.9%, compared to a 3.3% decrease in the industry [3]