Clinical Trial Results - Dapirolizumab pegol (DZP) met its primary endpoint, showing statistically and clinically significant improvement across all organ systems as measured by BICLA, with a 14.6% higher response rate (49.5%) compared to standard of care (SOC) alone (34.6%) [1][2] - Participants receiving DZP experienced 50% fewer severe disease flares compared to those on SOC alone [1] - At Week 24, DZP plus SOC showed a 7.9% higher BICLA response rate (46.6%) compared to SOC alone (38.3%), though the difference was not statistically significant [3] Secondary Endpoints and Clinical Improvements - 17.1% more participants receiving DZP reduced their corticosteroid dose from >7.5 mg/day to ≤7.5 mg/day at Week 48 (72.4% vs. 52.9%) [4] - DZP plus SOC showed an 18.8% higher SRI-4 response rate at Week 48 (60.1% vs. 41.1%) [4] - A 1.8-fold greater decrease in SLEDAI-2K was observed in the DZP group compared to SOC alone at Week 48 (-6.1 vs. -4.2) [4] - 20.9% more participants in the DZP group achieved Lupus Low Disease Activity State (LLDAS) at Week 48 (40.9% vs. 19.6%) [4] Safety Profile - The safety profile of DZP was generally favorable, with 82.6% of participants experiencing treatment-emergent adverse events (TEAEs) compared to 75.0% in the SOC group [6] - Serious TEAEs were reported in 9.9% of participants receiving DZP plus SOC compared to 14.8% in the SOC group [6] - Opportunistic infections were reported in 2.8% of participants receiving DZP plus SOC compared to 0.9% in the SOC group [6] Disease Background - Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease affecting multiple organ systems, primarily in women, with 90% of cases occurring in women aged 15-55 [9] - SLE is associated with a higher risk of death from infections and cardiovascular disease, and pregnancy in women with SLE carries higher maternal and fetal risks [9] Drug Mechanism and Development - Dapirolizumab pegol is a novel Fc-free anti-CD40L drug candidate that inhibits CD40L signaling, reducing B cell activation and autoantibody production [10] - The drug is currently in Phase 3 clinical development for SLE under a collaboration between UCB and Biogen [10] Company Information - UCB is a global biopharmaceutical company focused on severe diseases of the immune system and central nervous system, listed on Euronext Brussels [11] - Biogen is a leading biotechnology company pioneering innovative science to deliver new medicines, founded in 1978 [12]

Needham downgraded Biogen Inc BIIB, citing limited catalysts for the company over the next year.Alzheimer’s drug Leqembi’s (lecanemab) sales growth is expected to stay gradual without a sharp increase in the near future. The analyst remarked that the physician feedback and expert opinions indicate this slow pace will continue.Leqembi’s third-quarter global in-market sales were approximately $67 million, including U.S. in-market sales of approximately $39 million.Although investors are aware of this, market ...

Biogen Inc.’s (BIIB) Japan-based partner, Eisai announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion recommending marketing approval for Leqembi (lecanemab) for early Alzheimer’s disease.The CHMP recommended marketing approval for Leqembi as a treatment of adult patients with early Alzheimer’s disease who are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes with confirmed amyloid pathology in Europe.A final deci ...

Investors with an interest in Medical - Biomedical and Genetics stocks have likely encountered both Biogen Inc. (BIIB) and Myriad Genetics (MYGN) . But which of these two stocks offers value investors a better bang for their buck right now? We'll need to take a closer look.There are plenty of strategies for discovering value stocks, but we have found that pairing a strong Zacks Rank with an impressive grade in the Value category of our Style Scores system produces the best returns. The proven Zacks Rank put ...

Here at Zacks, our focus is on the proven Zacks Rank system, which emphasizes earnings estimates and estimate revisions to find great stocks. Nevertheless, we are always paying attention to the latest value, growth, and momentum trends to underscore strong picks.Of these, value investing is easily one of the most popular ways to find great stocks in any market environment. Value investors use tried-and-true metrics and fundamental analysis to find companies that they believe are undervalued at their current ...

Investment Group Overview - The investment group Haggerston BioHealth caters to both novice and experienced biotech investors, providing catalysts, buy/sell ratings, product sales forecasts, integrated financial statements, discounted cash flow analysis, and market-by-market analysis [2] - The group offers at least 4 exclusive stock tips weekly, focusing on Pharma, Biotech, and Healthcare sectors, alongside access to investment bank-grade financial models and research [1] - Edmund Ingham, a biotech consultant with over 5 years of experience covering biotech, healthcare, and pharma, leads the group and has compiled detailed reports on over 1,000 companies [2] Services and Expertise - The group provides detailed forecasts and sales data for all major pharmaceutical companies, along with integrated financial statements and discounted cash flow analysis [2] - Members can invest alongside a model portfolio or access high-quality financial models and research tailored to the biotech and healthcare sectors [1] - The group's focus on catalysts and market analysis helps investors identify potential opportunities and risks in the biotech and healthcare industries [2]

Biogen Inc BIIB reported upbeat earnings for the third quarter on Wednesday.The company pisted third-quarter adjusted EPS of $4.08, down 6%, beating the consensus of $3.79. The company reported sales of $2.47 billion, down 3% year over on constant currency and reported basis, beating the consensus of $2.43 billion.Biogen raised its 2024 adjusted EPS guidance to $16.10-$16.60 versus prior guidance of $15.75-$16.25 and consensus of $16.19. Biogen continues to expect 2024 revenue to decline by a low-single-dig ...

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 September 30, 2024 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 incorporation or organization)(I.R.S. Employer ...

Biogen (BIIB) reported third-quarter 2024 adjusted earnings per share (EPS) of $4.08, which beat the Zacks Consensus Estimate of $3.77. While earnings declined 6% year over year on a reported basis, it remained flat on a constant-currency basis. Total revenues came in at $2.47 billion, down 3% year over year on both reported and constant-currency basis. This decline was due to lower sales of key multiple sclerosis (MS) drugs like Tecfidera and Tysabri as well as spinal muscular atrophy (SMA) drug Spinraza, ...

Financial Data and Key Metrics - Total revenue for Q3 2024 was $2.5 billion, down 3% YoY [30] - Non-GAAP diluted EPS was $4.08, down 6% YoY [30] - Non-GAAP operating income increased 4% YoY [30] - MS product revenue declined by 9% due to competitive dynamics [31] - Rare disease franchise revenue grew 10% to $495 million [32] - SPINRAZA global revenue declined 15% to $381 million, impacted by a loss of an annual tender in Russia [33] - ZURZUVAE revenue increased 49% to $22 million [34] - LEQEMBI global in-market sales grew 66% to $67 million [34] Business Line Performance - LEQEMBI global revenue grew 66% QoQ, with US revenue up 33% [7][34] - SKYCLARYS US revenue increased 8% to $82 million, with global revenue reaching $102 million [32] - ZURZUVAE saw a 49% increase in revenue, driven by a 40% increase in patients [11][34] Market Performance - LEQEMBI saw strong uptake outside the US, particularly in Japan where revenue nearly doubled QoQ [8] - SKYCLARYS is generating revenue in 15 markets outside the US, with increased demand in Europe [10][32] - SPINRAZA US revenue grew 2% to $153 million, despite global challenges [33] Strategic Direction and Industry Competition - The company is focused on sustainable growth, building a robust pipeline, and developing future leaders [12] - LEQEMBI's growth is expected to continue, with potential catalysts like IV maintenance and subcutaneous formulations [9] - The company is expanding its immunology pipeline, with significant potential in lupus and other immune-mediated diseases [14][21] - The late-stage pipeline has a cumulative peak revenue potential of $14 billion, which could transform the company [14] Management Commentary on Operating Environment and Future Outlook - The company is optimistic about its late-stage pipeline and the potential for transformative medicines [12][27] - Management highlighted the complexity of the LEQEMBI launch but remains confident in its long-term potential [41] - The company is actively evaluating business development opportunities to enhance near-term growth [50] Other Important Information - The company raised its full-year 2024 non-GAAP diluted EPS guidance to $16.10-$16.60, reflecting expected growth of 11% at the midpoint [38] - The European Patent Office upheld the validity of Biogen's TECFIDERA patent, though generics continue to challenge it [31] - The company ended the quarter with $1.7 billion in cash and marketable securities and $4.6 billion in net debt [37] Q&A Session Summary Question: LEQEMBI's commercial efforts and alignment with Eisai - Management discussed the complexity of the LEQEMBI launch and the ongoing collaboration with Eisai to refine the commercial strategy [41][42] - The expanded field force has shown early signs of accelerating growth, particularly in regions with strong physician relationships [43] Question: Subcutaneous formulation updates for LEQEMBI - The subcutaneous maintenance filing is expected to be completed soon, with regulatory outcomes for induction therapy anticipated by Q1 2026 [45] Question: SKYCLARYS pricing and reimbursement dynamics in Europe - Revenue generation in Europe is influenced by country-specific reimbursement negotiations, with patient demand growing ahead of revenue conversion [49] Question: Business development strategy - The company is actively looking for assets that can enhance near-term growth and provide a good return on investment, with significant financial capacity for acquisitions [50][51] Question: AHEAD 3-45 study timeline and potential interim analysis - Enrollment for the AHEAD 3-45 study was completed in October, with a 216-week timeline and ongoing engagement with regulators for potential early readouts [54] Question: Lupus pipeline and competition from CD19 CAR-Ts - The company remains optimistic about its lupus pipeline, emphasizing the need for multiple treatment options and the potential of its CD40 ligand inhibitor [57][58] Question: SPINRAZA growth potential and high-dose nusinersen - SPINRAZA's growth is supported by its strong efficacy profile and the potential of high-dose nusinersen to accelerate therapeutic benefits [64][65] Question: Strategic focus on neurology vs immunology - The company remains committed to neurology but is also expanding into immunology and rare diseases, leveraging its existing capabilities and commercial model [69] Question: Margin outlook for 2025 - The company expects continued margin improvement in 2025, driven by ongoing cost-saving initiatives and operational efficiencies [72]