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]

Core Insights - Biogen Inc. reported quarterly earnings of $3.02 per share, missing the Zacks Consensus Estimate of $3.26 per share, and down from $3.67 per share a year ago, representing an earnings surprise of -7.36% [1] - The company posted revenues of $2.43 billion for the quarter, exceeding the Zacks Consensus Estimate by 8.91%, and up from $2.29 billion year-over-year [2] - Biogen shares have declined approximately 20.8% since the beginning of the year, compared to a decline of -5.3% for the S&P 500 [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is $4.10 on revenues of $2.33 billion, and for the current fiscal year, it is $15.63 on revenues of $9.17 billion [7] - The estimate revisions trend for Biogen is mixed, resulting in a Zacks Rank 3 (Hold), indicating expected performance in line with the market [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Biogen belongs, is currently in the top 32% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8] - Another company in the same industry, Puma Biotech, is expected to report quarterly earnings of $0.02 per share, reflecting a year-over-year change of +140%, with revenues anticipated at $43.96 million, up 0.4% from the previous year [9][10]

Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was $2.4 billion, up 6% year over year, aided by timing of SPINRAZA and corporate partner revenue shipments [44] - Non-GAAP diluted EPS for Q1 was $3.02, down 18%, impacted by a $165 million upfront payment related to the Stoke transaction [44] - Free cash flow generated in Q1 was $222 million, ending the quarter with $2.6 billion in cash [45][52] Business Line Data and Key Metrics Changes - Global product revenue from the MS franchise declined 11% year over year, primarily due to competition from biosimilars and generics [45] - VUMERITY saw increased demand, remaining the number one branded oral therapy [45] - SPINRAZA revenue grew by 4% year over year in the US, with a one-time VAT refund contributing to ex-US revenue [46][47] - Launch products generated approximately $200 million in revenue, increasing 22% quarter over quarter and more than doubling year over year [44][47] - Skyclaris revenue was $124 million, up 59% year over year and 21% quarter over quarter [17][48] Market Data and Key Metrics Changes - Skyclaris has been successful in Europe, with a significant number of patients identified and treated [19][22] - The approval of Lekembi in Europe is expected to enhance market penetration, especially in aging populations [66] - The company has seen a steady growth in patient numbers for Skyclaris, with approximately 2,400 patients on therapy globally [20] Company Strategy and Development Direction - The company is focusing on expanding its pipeline through external innovation and partnerships, particularly in rare diseases and immunology [8][24] - A major restructuring of research has been initiated to enhance collaboration and focus on preclinical partnerships [58] - The company aims to balance its pipeline between neurology and immunology, with a strong emphasis on addressing unmet needs in both areas [25][26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the pipeline's potential to deliver sustainable long-term growth, with several key approvals and data readouts expected [35] - The company is monitoring the impact of tariffs but does not expect a material impact on its 2025 financial outlook [55][56] - Management highlighted the importance of early diagnosis and treatment in Alzheimer's disease, emphasizing the potential of blood-based diagnostics [78] Other Important Information - The company plans to disclose a schedule of expected charges for each quarter to improve transparency regarding R&D activities [50] - The company is on track to deliver significant savings under its Fit for Growth initiative, with expectations of $1 billion in gross savings [54] Q&A Session Summary Question: Can you talk about the rollout strategy for Lekembi in Europe? - Management indicated that the rollout will take time, as Lekembi is a first-in-class agent that adds to the healthcare budget rather than displacing existing products [66] Question: How can the subcutaneous formulation of Lekembi help accelerate sales in the US? - Management noted that the subcutaneous formulation simplifies administration for patients and physicians, potentially increasing long-term treatment adherence [72] Question: What are the latest thoughts on business development opportunities? - Management observed a shift in the market, with more companies seeking liquidity, which may create opportunities for acquisitions and collaborations [89]

Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was $2.4 billion, up 6% year over year, aided by timing of SPINRAZA and corporate partner revenue shipments [44] - Non-GAAP diluted EPS for Q1 was $3.02, down 18%, impacted by a $165 million upfront payment related to the Stoke transaction [44][50] - Free cash flow generated in Q1 was $222 million, ending the quarter with $2.6 billion in cash [45][51] Business Line Data and Key Metrics Changes - The MS franchise saw a global product revenue decline of 11% year over year, primarily due to competition from biosimilars and generics [45] - VUMERITY showed increased demand, remaining the number one branded oral therapy [46] - SPINRAZA revenue grew by 4% year over year in the US, with a one-time VAT refund contributing to ex-US revenue [46][47] - Launch products generated approximately $200 million in revenue, increasing 22% quarter over quarter and more than doubling year over year [44][47] Market Data and Key Metrics Changes - Skyclaris had worldwide sales of $124 million, up 59% year over year and 21% quarter over quarter [18] - The company has treated approximately 2,400 patients globally with Skyclaris, now available in 26 markets [21] - The approval of Lekembi in Europe is expected to significantly impact market penetration, especially in an aging population [66] Company Strategy and Development Direction - The company is focusing on expanding its pipeline through external innovation and partnerships, particularly in rare diseases and immunology [10][24] - A major restructuring of research is underway to enhance collaboration and focus on preclinical opportunities [58] - The company aims to establish a strong presence in both neurology and immunology, balancing its therapeutic areas for future growth [25][26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the pipeline, with multiple phase three studies and regulatory decisions expected in the near future [29][35] - The company does not anticipate a material impact from potential tariffs in 2025, citing a diversified revenue base and strong US manufacturing presence [55][56] - The management highlighted the importance of early diagnosis and treatment in Alzheimer's disease, emphasizing the potential of blood-based diagnostics [78][80] Other Important Information - The company is committed to achieving $1 billion in gross savings and $800 million in net savings under its Fit for Growth initiative [54] - The company plans to provide better transparency regarding R&D activities by breaking out acquired in-process R&D charges in financial reports [50] Q&A Session Summary Question: Can you talk about the rollout strategy for Lekembi in Europe? - Management indicated that the rollout will take time, as Lekembi is a first-in-class agent that adds to healthcare budgets rather than displacing existing products [64][66] Question: How can the subcutaneous formulation of Lekembi help accelerate sales in the US? - The subcutaneous formulation is expected to simplify administration for patients and physicians, potentially increasing long-term treatment adherence [71][75] Question: What are the thoughts on Lekembi's uptake and growth with the new diagnostic tools? - Management noted that early diagnosis is crucial for treatment efficacy, and blood-based diagnostics could facilitate earlier patient engagement [78][80] Question: How is the market differentiating between Lekembi and Lilly's Kusuma? - Management believes the market will split based on physician and patient preferences, emphasizing the need for education on the importance of continued treatment [82][86] Question: What are the latest thoughts on business development opportunities? - Management acknowledged a shift in the market, with increased pressure on healthcare investors leading to potential liquidity opportunities for Biogen [88]

[Performance Overview](index=1&type=section&id=Performance%20Overview) Biogen's Q1 2025 saw total revenue rise 6% to $2.4 billion, though diluted EPS declined due to a $165 million payment, with new products now comprising 45% of total product revenue Q1 2025 Financial Highlights | | Q1 '25 | Q1 '24 | △ | |---|---|---|---| | Total Revenue (in millions) | $2,431 | $2,290 | 6% | | GAAP diluted EPS | $1.64 | $2.70 | (39)% | | Non-GAAP diluted EPS | $3.02 | $3.67 | (18)% | - The decline in EPS includes a significant impact of approximately **($0.95) per share** from a **$165 million** upfront payment to Stoke Therapeutics for the zorevunersen collaboration[5](index=5&type=chunk)[7](index=7&type=chunk) - The company's commercial portfolio is transforming, with revenue from products outside the Multiple Sclerosis (MS) business now constituting approximately **45%** of total product revenue[4](index=4&type=chunk) - Biogen highlights its significant U.S. manufacturing presence, noting that roughly **75%** of its 2024 U.S. product revenues were from products with manufacturing operations in the U.S[4](index=4&type=chunk) [Financial Performance](index=2&type=section&id=Financial%20Performance) Q1 2025 financial performance saw revenue growth from rare disease and contract manufacturing, offsetting declines in MS and biosimilars, while increased acquired IPR&D expenses were managed by cost-saving initiatives, maintaining a solid cash position [Revenue Analysis](index=2&type=section&id=Revenue%20Analysis) Total revenue increased 6% to $2.43 billion, driven by strong growth in Rare Disease and Contract Manufacturing, partially offset by declines in MS and Biosimilars, with significant growth in Alzheimer's collaboration revenue Q1 2025 Revenue by Segment (in millions) | Segment | Q1 '25 | Q1 '24 | △ | |---|---|---|---| | Multiple sclerosis (MS) product revenue | $953 | $1,076 | (11)% | | Rare disease revenue | $563 | $424 | 33% | | Biosimilars revenue | $181 | $197 | (8)% | | Alzheimer's collaboration revenue | $33 | $3 | NMF | | Contract manufacturing, royalty and other revenue | $293 | $182 | 61% | | **Total revenue** | **$2,431** | **$2,290** | **6%** | [Expense Analysis](index=2&type=section&id=Expense%20Analysis) GAAP Cost of Sales increased to 26% of revenue, R&D expenses decreased by 3%, while Acquired IPR&D significantly rose to $201 million due to collaboration payments, and SG&A expenses remained flat Q1 2025 Expense Summary (GAAP, in millions) | Expense Category | Q1 '25 | Q1 '24 | △ | |---|---|---|---| | Cost of sales | $629 | $542 | (16)% | | R&D expense | $434 | $445 | 3% | | SG&A expense | $573 | $582 | 2% | | Acquired IPR&D, upfront and milestone expense | $201 | $8 | NMF | - The increase in Acquired IPR&D expense was driven by a **$165 million** upfront payment to Stoke for the zorevunersen collaboration and a **$35 million** milestone payment to MorphoSys AG for the felzartamab Phase 3 trial initiation[14](index=14&type=chunk) [Financial Position and Cash Flow](index=3&type=section&id=Financial%20Position%20and%20Cash%20Flow) As of March 31, 2025, Biogen reported a net debt of approximately $3.7 billion, with $2.6 billion in cash and $6.3 billion in total debt, generating $259 million in net cash flow from operations and $222 million in free cash flow Key Financial Position & Cash Flow Data (as of Q1 2025) | Metric | Value (in millions) | |---|---| | Cash and cash equivalents | $2,598 | | Total Debt | ~$6,300 | | Net Debt | ~$3,700 | | Net cash flow from operations | $259 | | Free cash flow | $222 | [Business and Pipeline Highlights](index=1&type=section&id=Business%20and%20Pipeline%20Highlights) Biogen reported strong commercial momentum for new products like LEQEMBI and SKYCLARYS, while strengthening its pipeline with new collaborations and advancing key candidates like BIIB080 which received FDA Fast Track designation - LEQEMBI global in-market sales reached approximately **$96 million**, with U.S. sales contributing **$52 million**[5](index=5&type=chunk) - Global SKYCLARYS revenue was approximately **$124 million**, showing continued demand growth[5](index=5&type=chunk) - The pipeline was expanded with an agreement for zorevunersen (Dravet syndrome) and initiation of a Phase 3 study for felzartamab (kidney transplant rejection)[5](index=5&type=chunk) - BIIB080, an investigational ASO therapy for Alzheimer's disease, received FDA Fast Track designation[5](index=5&type=chunk) - The Phase 2b LUMA study for BIIB122 (Parkinson's disease), in collaboration with Denali Therapeutics, is fully enrolled with a readout expected in 2026[27](index=27&type=chunk) [Full Year 2025 Financial Guidance](index=4&type=section&id=Full%20Year%202025%20Financial%20Guidance) Biogen updated its full-year 2025 Non-GAAP diluted EPS guidance to $14.50-$15.50, reflecting a negative impact from the Stoke payment partially offset by foreign exchange, while expecting a mid-single digit revenue decline and $800 million in 'Fit for Growth' savings Full Year 2025 Non-GAAP Diluted EPS Guidance Update | | Amount | |---|---| | Prior Guidance (February 2025) | $15.25 to $16.25 | | Approx. impact from Stoke upfront payment | ($0.95) | | Benefit mainly from foreign exchange | +$0.20 | | **Updated Guidance** | **$14.50 to $15.50** | - Full year 2025 total revenue is expected to decline by a **mid-single digit percentage** at constant currency versus 2024[5](index=5&type=chunk)[16](index=16&type=chunk) - The 'Fit for Growth' program is expected to generate approximately **$800 million** in net savings by the end of 2025, with combined Non-GAAP R&D and SG&A expenses projected to be **~$3.9 billion**[16](index=16&type=chunk) [Financial Statements (Tables)](index=8&type=section&id=Financial%20Statements%20%28Tables%29) This section provides detailed unaudited financial statements for Q1 2025, including the Condensed Consolidated Statement of Income, Balance Sheets, Product Revenue breakdown, and GAAP to Non-GAAP reconciliations for key metrics [Table 1: Condensed Consolidated Statement of Income](index=8&type=section&id=Table%201%3A%20Condensed%20Consolidated%20Statement%20of%20Income) This table presents the company's Q1 2025 revenues, costs, and expenses, resulting in a net income of $240.5 million and diluted EPS of $1.64, compared to $393.4 million and $2.70 respectively in Q1 2024 Q1 2025 vs Q1 2024 Statement of Income Highlights (in millions) | | For the Three Months Ended March 31, | |---|---|---| | | 2025 | 2024 | | Total revenue | $2,431.0 | $2,290.5 | | Total cost and expense | $2,119.8 | $1,825.7 | | Income before income tax | $311.2 | $464.8 | | Net income attributable to Biogen Inc. | $240.5 | $393.4 | | Diluted earnings per share | $1.64 | $2.70 | [Table 2: Condensed Consolidated Balance Sheets](index=9&type=section&id=Table%202%3A%20Condensed%20Consolidated%20Balance%20Sheets) This table illustrates the company's financial position as of March 31, 2025, showing total assets of $28.03 billion, with cash and cash equivalents at $2.60 billion and total liabilities at $11.05 billion Balance Sheet Highlights (in millions) | | As of March 31, 2025 | As of December 31, 2024 | |---|---|---| | Cash and cash equivalents | $2,598.3 | $2,375.0 | | Total current assets | $7,626.0 | $7,456.8 | | TOTAL ASSETS | $28,033.1 | $28,049.3 | | Total current liabilities | $5,297.4 | $5,528.8 | | TOTAL LIABILITIES AND EQUITY | $28,033.1 | $28,049.3 | [Table 3: Product Revenue Details](index=10&type=section&id=Table%203%3A%20Product%20Revenue%20Details) This table provides a detailed breakdown of product revenues by drug and region, highlighting declining TYSABRI sales, growing SPINRAZA sales, and strong uptake of new products like SKYCLARYS and ZURZUVAE Q1 2025 Key Product Revenue (in millions) | Product | Q1 2025 Total Revenue | Q1 2024 Total Revenue | |---|---|---| | TYSABRI | $381.5 | $431.3 | | SPINRAZA | $423.9 | $341.3 | | SKYCLARYS | $123.9 | $78.0 | | ZURZUVAE | $27.7 | $12.4 | [Table 4: GAAP to Non-GAAP Reconciliation](index=11&type=section&id=Table%204%3A%20GAAP%20to%20Non-GAAP%20Reconciliation) This table details adjustments reconciling GAAP to Non-GAAP measures for Q1 2025, including $101.3 million for amortization and $49.4 million for inventory fair value step-up, bridging GAAP diluted EPS of $1.64 to Non-GAAP diluted EPS of $3.02 Q1 2025 GAAP to Non-GAAP EPS Reconciliation | | Per Share Amount | |---|---| | Total diluted earnings per share, GAAP | $1.64 | | Adjustments to GAAP net income | $1.38 | | **Total diluted earnings per share, Non-GAAP** | **$3.02** | Q1 2025 Free Cash Flow Reconciliation (in millions) | | Amount | |---|---| | Net cash provided by operating activities | $259.3 | | Less: Purchases of property, plant and equipment | $37.1 | | **Free cash flow** | **$222.2** |

Core Viewpoint - Analysts forecast a decline in Biogen Inc.'s quarterly earnings and revenues, indicating potential challenges for the company in the upcoming earnings report [1]. Earnings and Revenue Estimates - Biogen is expected to report earnings of $3.32 per share, reflecting a year-over-year decline of 9.5% [1]. - Revenue is anticipated to be $2.23 billion, showing a decrease of 2.6% compared to the same quarter last year [1]. - Over the past 30 days, the consensus EPS estimate has been adjusted upward by 0.1%, indicating a slight positive reassessment by analysts [2]. Product-Specific Revenue Estimates - Revenue from Multiple Sclerosis (MS) product TYSABRI is estimated at $364.47 million, down 15.5% year-over-year [5]. - Revenue from Rare Disease product SPINRAZA is projected at $365.01 million, up 7% year-over-year [5]. - Total net revenue from products is expected to reach $1.66 billion, reflecting a decline of 3% from the previous year [6]. - Revenue from Anti-CD20 therapeutic programs is estimated at $411.57 million, indicating a growth of 4.5% year-over-year [6]. Regional Revenue Estimates - Revenue from MS product TYSABRI in the United States is forecasted at $191.97 million, down 10.2% year-over-year [9]. - Revenue from MS product Fumarate (TECFIDERA) in the United States is expected to be $31.40 million, reflecting a significant decline of 28.1% [9]. - Revenue from SPINRAZA in the United States is projected at $160.72 million, up 8.2% year-over-year [7]. - Revenue from MS product Interferon in the United States is expected to be $119.70 million, down 14.4% year-over-year [10]. Market Performance - Over the past month, Biogen shares have decreased by 9%, contrasting with the Zacks S&P 500 composite's slight decline of 0.2% [10]. - Biogen holds a Zacks Rank of 3 (Hold), suggesting that its performance may align with the overall market in the near term [10].

Industry Overview - The first-quarter earnings season for the drug and biotech sector is underway, with major companies like Pfizer, Eli Lilly, Amgen, Biogen, and Regeneron set to announce results [1] - Johnson & Johnson and Merck have reported results, both exceeding first-quarter estimates for earnings and sales, while Sanofi had mixed results, beating earnings estimates but missing sales [1] Earnings Trends - As of April 23, 15% of companies in the Medical sector, representing 33.8% of the sector's market capitalization, reported quarterly earnings, with 77.8% surpassing estimates for both earnings and revenues [3] - Year-over-year earnings increased by 4.7%, and revenues rose by 9.4% [3] - Overall, first-quarter earnings for the Medical sector are expected to increase by 35%, while sales are projected to rise by 7.8% compared to the previous year [3] Company Performance Pfizer (PFE) - Pfizer has consistently exceeded earnings expectations in the last four quarters, with an average earnings surprise of 44.16% [5] - The Zacks Consensus Estimate for first-quarter sales and earnings is $13.88 billion and 64 cents per share, respectively [6] - Non-COVID operational revenues are driving growth, supported by products like Vyndaqel, Padcev, and Eliquis, despite a decline in sales of COVID products [7] Eli Lilly (LLY) - Eli Lilly has had mixed performance, exceeding earnings expectations in three of the last four quarters, with an average earnings surprise of 8.47% [8] - The Zacks Consensus Estimate for sales and earnings is $12.62 billion and $3.52 per share, respectively [8] - Growth is expected to be driven by demand for FDA-approved tirzepatide medicines, although sales of Mounjaro and Zepbound were below expectations [9][10] Amgen (AMGN) - Amgen has shown strong performance, beating earnings estimates in each of the last four quarters, with an average earnings surprise of 5.23% [11] - The Zacks Consensus Estimate for first-quarter sales and earnings is $7.96 billion and $4.15 per share, respectively [11] - Product sales are expected to be driven by strong volume growth, although prices may decline due to higher rebates [12] Biogen (BIIB) - Biogen has consistently beaten earnings estimates in the last four quarters, with an average earnings surprise of 11.80% [13] - The Zacks Consensus Estimate for sales and earnings is $2.23 billion and $3.52 per share, respectively [13] - Lower sales of multiple sclerosis drugs are likely to be offset by revenues from new drugs [14] Regeneron (REGN) - Regeneron has had mixed results, surpassing earnings expectations in three of the last four quarters, with an average earnings surprise of 3.23% [16] - The Zacks Consensus Estimate for first-quarter sales and earnings is $3.28 billion and $8.43 per share, respectively [17] - Sales of Eylea are expected to have declined due to competition, but sales of Eylea HD and Dupixent are likely to have surged [18][19]

Company Overview - Biogen Inc. (BIIB) is a profit-generating company that has experienced significant declines in earnings and share price over recent years, primarily due to decreasing revenue from its legacy Multiple Sclerosis treatments [1]. Investment Insights - The article emphasizes the importance of patient investing through both good and bad times, highlighting that wealth is created through the slow accumulation of high-quality assets [1]. - It suggests that mixing a steady investment approach with high-risk/high-reward opportunities and transformative technologies can enhance the investment experience [1].