Regeneron Pharmaceuticals (REGN) official guidance

We now expect to report interim 26-week data from an exploratory cohort of our ongoing phase II/III study in early 2027, where we hope to see a trend towards slowing of lesion growth comparable to the approved agents at a similar time point.

Together, they are being evaluated as a combination therapy for paroxysmal nocturnal hemoglobinuria, or PNH, where we expect to report pivotal results by the end of the year.

We expect pivotal results from our knee replacement program starting next year, with other pivotal studies expected to read out in 2028 and beyond.

In 2028, we expect initial results from our first-line study in transplant-ineligible patients, as well as from our linvoseltamab carfilzomib combination study in patients who have received at least one prior line of therapy.

In 2027, we expect initial results from our confirmatory trial of linvoseltamab monotherapy versus standard of care in patients with multiple myeloma who have received at least one prior line of therapy.

Importantly, we expect results in 2028 from our fully enrolled phase III study of odronextamab monotherapy in first-line follicular lymphoma, which could provide these patients, who have high unmet need, with the first bispecific and chemo-free immunotherapy option.

At the American Autonomic Society Congress in November, we will be reporting initial results from our phase II study.

We are planning to initiate a potentially registrational study in the first half of next year, pending regulatory feedback, and we believe this could be a game-changing treatment for a debilitating disease with significant unmet need.

The one remaining phase III study yet to initiate in secondary stroke prevention is expected to begin enrollment by year-end.

We are also enrolling a potentially registrational cohort in second-line light chain amyloidosis and plan to start a phase III study in first-line light chain amyloidosis by early 2027.

Our first-in-human trial for our lead IL-13 antibody, which has a target dosing interval of every three to six months, is currently enrolling patients with atopic dermatitis, with registrational trials expected to begin in late 2027 and 2028.

Our first-in-human trial for our lead IL-13 antibody, which has a target dosing interval of every three to six months, is currently enrolling patients with atopic dermatitis, with registrational trials expected to begin in late 2027 and 2028.

We plan to build on our groundbreaking results combining our BCMA bispecific with Dupixent by expeditiously pursuing this more targeted approach, with clinical studies of this new bispecific antibodies to start in the first half of 2027.

We plan to begin registrational studies of this combination next year.

Three additional programs, a long-acting IL-4/13 bispecific, a long-acting antibody to IL-4 receptor alpha, and an IL-4 ligand antibody, are expected to enter the clinic next year.

We saw durable responses in heavily pre-treated patients at rates well above those historically seen with available therapies. We are already enrolling a dedicated, potentially registrational cohort and plan to start a confirmatory phase III study next year.

This year alone, we are on pace to initiate more than 15 phase III trials.

For EYLEA, we expect a sequential demand decline in the low to mid-teens in the fourth quarter.

Looking ahead to the fourth quarter, we expect continued EYLEA HD momentum, with sequential physician unit demand growth of approximately 10%, partially offset by ongoing pricing pressure, resulting in full-year net sales growth of over 50% compared with 2025.

Regarding our 2027 effective tax rate, we expect approximately 100-200 basis points of upward pressure relative to 2026, consistent with our prior long-term tax rate commentary.