Healthcare: Biotechnology: 2H26: check down on key catalysts and investor debates through year-end

Research evidence excerpt

Healthcare: Biotechnology: 2H26: check down on key catalysts and investor debates through year-end

Goldman Sachs Healthcare: Biotechnology

~5.6 months for Humira), despite a more aggressive taper. We view NIU as a potentially

underappreciated $4.1B peak sales opportunity ($3.5B risk-adjusted), well above VA

consensus of ~$2B, supported by an established treated market (~47-50k US patients

on TNFi, growing ~11% CAGR).

n Post data, we expect debate to shift to: i) magnitude of earlier-line (1L) adoption vs.

our conservative 15%/40% penetration in 1L/2L; ii) competitive positioning, where

the pipeline remains sparse; and iii) upside to prevalence/diagnosis assumptions if

improved therapies expand referral capture.

n If CLARITY is positive, we expect brepo to be increasingly viewed as a

multi-indication franchise, with NIU validating an expansion opportunity potentially

exceeding the lead DM indication in peak sales, as suggested by management.

n If CLARITY completely fails, we would remove NIU revenue from our model entirely,

which would result in a DCF value of $40, representing -18% vs our current $49 price

target.

ROIV: Ph2 PHocus - Pulmonary Hypertension-Interstitial Lung Disease

Background: Following its 2024 announced acquisition of mosliciguat, ROIV embarked

on a Ph2 study of the drug in pulmonary hypertension with interstitial lung disease

(PH-ILD; primary endpoint: change in pulmonary vascular resistance), a category of

pulmonary hypertension with limited treatment options and a challenging prognosis.

Mosliciguat has previously been studied in a Ph2a in other pulmonary hypertension

categories (PAH, Cpc-PH) where it demonstrated up to 38% reduction in pulmonary

vascular resistance (PVR), the same endpoint as will be tested in PHocus.