Total Revenue

-3% " " " " "

Lower multiple sclerosis (MS) product revenue due to continued generic competition was the main driver of the decline, partially offset by growth in rare disease and Other segment revenue from new product launches. Changes in foreign exchange rates also slightly impacted the overall result. " " " " "

Operating Income (EBIT)

Improved from -US$141.2M to US$451M " "

Cost-reduction initiatives (Fit for Growth), a favorable shift in product mix, and the absence of prior-year restructuring charges helped turn a negative EBIT into a positive figure. Additionally, one-time benefits, including proceeds from a voucher sale, contributed to the improved operating performance. " "

Net Income

Improved from -US$68.1M to US$388.5M " "

Higher profitability in new and rare disease products, along with lower R&D and reduced SG&A expenses, drove net income growth. The absence of certain charges that were present in the previous period also boosted the bottom line, despite ongoing MS revenue pressure. " "

Multiple Sclerosis

-9% " " " " "

TECFIDERA and TYSABRI faced increased competition and pricing pressures, reducing demand. Continued shifts of patients to higher-efficacy therapies weakened interferon sales. These challenges led to ongoing erosion in MS product revenue. " " " " "

Rare Disease

+10% " " " " "

Strong uptake of SKYCLARYS and other rare disease therapies drove substantial revenue growth, more than offsetting the slight decline in older rare disease assets. Favorable pricing and expanded patient access in some regions further supported performance. " " " " "

Anti-CD20 Therapeutic Programs

+6% " " " " "

Higher royalty revenue from OCREVUS and stable U.S. profit-sharing contributions for RITUXAN, GAZYVA, and LUNSUMIO led to modest growth. Although RITUXAN faced biosimilar competition, improved performance of other assets offset much of the decline. " " " " "

Contract Manufacturing, Royalty, and Other

-18% " " " " "

Timing of batch production drove higher volumes in the prior year, which did not repeat at the same level this year. Additionally, lower contract manufacturing revenue from certain products and changes in royalty streams contributed to the decline. " " " " "

Other Segment

+551% " " " " "

ZURZUVAE’s commercial launch and minimal revenue in the prior period resulted in a large percentage increase. Although the absolute revenue base remains relatively small, new product introductions contributed significantly to overall growth in this category. " " " " "

Rest of World

-6% " " "

Declines in MS revenue due to competition and foreign currency headwinds impacted Rest of World sales. While rare disease products saw some uptake, overall ROW performance was constrained by pricing pressures and shipment timing in certain international markets. " " "

Non-GAAP Diluted EPS

FY 2024

$15.75 to $16.25 "

$16.10 to $16.60 "

raised

Total Revenue

FY 2024

Decline by a low single-digit percentage "

Decline by a low single-digit percentage "

no change

Cost Savings (Fit for Growth)

FY 2024

No prior guidance

$1B gross / $800M net by 2025; half by end of 2024 " "

no prior guidance

Seasonal SG&A Spending

Q4 2024

No prior guidance

Expected to be higher in Q4 2024 "

no prior guidance

LEQEMBI

Previously, strong U.S. growth but facing EMA challenges (Q2), with sustained new patient growth. In Q1, it showed 2.5x increase from Q4 2023 and regulatory delay in Europe, and in Q4 2023, no explicit headwinds but focus on advancing approvals and expanding access. " " " " " " " " " " "

Global revenue up 66%, U.S. in-market sales +33% to $39 million, with a 40% increase in new prescribers. Launch complexities remain (infrastructure for scans and infusions), but optimism persists regarding future uptake, including a planned subcutaneous formulation and the AHEAD 3-45 study. " " " "

Continues strong U.S. trajectory. Earlier focus on European regulatory issues not reiterated in Q3.

SKYCLARYS

In Q2, sentiment remained consistently positive with ahead-of-forecast performance. In Q1, it showed strong market penetration and favorable coverage; and in Q4 2023, rapid uptake with about 1,000 patients on therapy and a focus on global expansion. " " " " " " " "

Strong global demand (+8% revenue in the U.S. to $82 million) but reimbursement challenges in Europe have caused lumpiness in revenue from early access programs. " "

Shift from purely strong uptake to increased caution around European reimbursement.

SPINRAZA

Q2 commentary stayed moderately optimistic amid competition. In Q1, U.S. revenue was +1% but a 35% decline abroad due to shipment timing/competition. In Q4 2023, Biogen was optimistic about growth potential while acknowledging competitive gene therapies. " " " "

Revenue $381 million (-15%), impacted by competitive pressures but showing some resilience (U.S. +2%) and hope for the DEVOTE study to improve outcomes. " "

Moved from optimism to uncertainty due to increasing competition, with possible stabilization efforts ongoing.

Lupus pipeline

In Q2, Phase III readouts for dapi and ongoing efforts with litifilimab/felzartamab were emphasized. Q1 focused on dapi and litifilimab with no felzartamab update, and Q4 2023 also featured dapi/litifilimab progress. " " " " " "

Dapirolizumab, litifilimab, and felzartamab highlighted as key drivers with possible $9‒$14B peak sales. Biogen shared encouraging Phase III data for dapi, continuing trials for litifilimab, and plans for felzartamab in lupus nephritis. " " "

Consistently cited as a significant long-term growth area, with increased revenue potential detail in Q3.

Angelman syndrome (BIIB121)

In Q2, Biogen opted out of the Angelman program (BIIB121), citing go/no-go priorities. In Q1, there was no mention, and in Q4 2023, encouraging interim Phase I data had been shared. " " "

Not mentioned in Q3 2024.

Likely deprioritized and no longer a near-term focus.

ZURZUVAE

Introduced in Q2 with 19% U.S. revenue growth and strong uptake. In Q1, it generated $12 million amid channel stocking, and in Q4 2023, Biogen highlighted an early focus on OB-GYN prescribers. " " " "

Reported $22 million revenue (+49% vs. Q2) with a 40% increase in patients, yet minimal additional discussion in Q3. " "

New product seeing steady growth, though less detail provided in Q3.

MS franchise pressures

Q2 and Q1 highlighted ongoing erosion in interferons, competitive headwinds for TYSABRI, and the risk of biosimilars. Q4 2023 also forecast declines due to generic entry and pricing pressures. " " " " "

No specific Q3 commentary beyond a 9% decline in MS product revenue, attributed to competition. "

Continued challenges remain but less emphasis in Q3.

Business development

Cited in Q2 (HI-Bio acquisition, strong capital for immunology/rare deals), Q1 (about $4–$5B capacity in 2024), and not referenced specifically in Q4 2023. " " "

Emphasized $8‒$10B capacity over the near term with a below 2x leverage ratio, aiming for value-creating deals to supplement future growth. "

Consistently a growth priority with ample financial resources to pursue strategic opportunities.