Biogen Inc. (NASDAQ: BIIB)*

As of 11 March 2025

SKYCLARYS (for Friedreich's ataxia)

Initial success with 1,100 patients was from centers of excellence where patients were already diagnosed

Current challenge is finding "needle in a haystack" patients in community settings who may be misdiagnosed with MS or ALS

Using sophisticated AI model generating 100+ leads daily and deploying multiple field forces to identify patients

Patient identification is "lumpy" - sometimes finding zero patients, sometimes finding ten, sometimes finding families

MS field force now also deployed to help identify patients

Revenue affected by inventory timing and Medicare Part D IRA redesign (30% revenue impact)

International expansion ongoing with approximately 15 markets, mostly in Europe

Brazil expected to launch later in 2025, representing half of all patients outside US/Europe

LEQEMBI (for Alzheimer's Disease)

Infrastructure remains a challenge but finding one "clinical champion" accelerates adoption at institutions

Physicians who prescribe often do so only for patients who specifically request it ("grant rate")

Biogen expanded field force and leveraged existing relationships to accelerate adoption

Planning broader DTC campaign, possibly including television advertising, based on high grant rates

Most physicians are in "wait and see" mode, concerned about side effect management

Some confusion caused by Lilly's 18-month stopping rule recommendation versus LEQEMBI's continuous treatment approach

IV maintenance approval now allows monthly dosing after 18 months

Blood-based biomarkers expected to be FDA-approved later this year or early next year

Subcutaneous administration option expected next year

SPINRAZA (for SMA)

Has grown for the past three years despite competition

Many patients are "switchbacks" who tried other options but returned for efficacy

High-dose SPINRAZA approval expected Q4 2025, addressing concerns about waning efficacy

Adult business is growth driver going forward

Over 70% of potential patients have tried treatment options

International markets are experiencing competition but holding ground

ZURZUVAE (for Postpartum Depression)

Originally prepared for MDD but only received PPD approval

Discovered OB/GYNs are primary prescribers, not psychiatrists as initially assumed

Treatment window is limited to the first 90 days postpartum

Only one 15-minute appointment window to diagnose and treat

Changed targeting from individual physicians to group practices

Considering DTC campaign as "perfect product" for direct consumer advertising

Recently expanded field force, evaluating impact before launching DTC

Pipeline

Current focus areas: lupus, Alzheimer's, and rare diseases

Excited about lupus program due to high unmet need

HI-Bio's Felza potential for kidney diseases

Positive on stroke program (ex-US)

Pipeline restructured under new leadership with regional president input