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Research: Healthcare
Nicox provided details of a US market survey evaluating the commercial potential of its lead candidate, NCX-470, a nitric oxide (NO) donating bimatoprost designed for the treatment of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension (OHTN). The independent market research agency commissioned by Nicox confirmed that NCX-470’s therapeutic profile, as shown in prior studies including the Phase III Mont Blanc trial, was positively received by stakeholders. Together with insights from Ocumension Therapeutics, the company’s NCX-470 partner in China and South-East Asia, Nicox estimates that annual global net sales of NCX-470 (excluding Europe) could exceed $300m within eight years of the product’s launch in the US and China, with US net sales estimated at $115–165m by year 8. We believe the US estimates may be conservative, given that US branded bimatoprost (Lumigan, AbbVie) sales exceeded $270m in 2021 and that NCX-470 is differentiated through its additional NO-mediated mechanism of action (in addition to its prostaglandin F2α mediated IOP lowering effects).
Nicox |
Nicox provides NCX-470 sales potential estimates |
Market research update |
Pharma and biotech |
13 July 2023 |
Share price performance
Business description
Analysts
Nicox is a research client of Edison Investment Research Limited. |
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Nicox provided details of a US market survey evaluating the commercial potential of its lead candidate, NCX-470, a nitric oxide (NO) donating bimatoprost designed for the treatment of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension (OHTN). The independent market research agency commissioned by Nicox confirmed that NCX-470’s therapeutic profile, as shown in prior studies including the Phase III Mont Blanc trial, was positively received by stakeholders. Together with insights from Ocumension Therapeutics, the company’s NCX-470 partner in China and South-East Asia, Nicox estimates that annual global net sales of NCX-470 (excluding Europe) could exceed $300m within eight years of the product’s launch in the US and China, with US net sales estimated at $115–165m by year 8. We believe the US estimates may be conservative, given that US branded bimatoprost (Lumigan, AbbVie) sales exceeded $270m in 2021 and that NCX-470 is differentiated through its additional NO-mediated mechanism of action (in addition to its prostaglandin F2α mediated IOP lowering effects).
Year end |
Revenue |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/21 |
8.6 |
(15.5) |
(0.32) |
0.0 |
N/A |
N/A |
12/22 |
5.2 |
(18.3) |
(0.34) |
0.0 |
N/A |
N/A |
12/23e |
6.6 |
(19.8) |
(0.39) |
0.0 |
N/A |
N/A |
12/24e |
7.6 |
(22.4) |
(0.44) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments. Revenue figures reflect gross revenues.
The research study involved ophthalmology key opinion leaders, glaucoma prescribers (US optometrists and ophthalmologists) and payors in a qualitative phase, followed by a quantitative internet survey involving 100 glaucoma prescribers. The study’s forecasts assume that new drug application regulatory filings would occur following the conclusion of the second NCX-470 Phase III study, Denali, which Nicox currently expects in 2025. Ocumension provided its own forecasts for NCX-470 sales for regions covered by their agreement (Nicox to be entitled to tiered royalties between 6–12% of net sales)
While NCX-470 did not demonstrate statistical superiority in lowering IOP compared to latanoprost in the Mont Blanc study, it did show non-inferiority to latanoprost at all nine tested timepoints, was numerically superior at all tested time points and statistically significant (p<0.049) at four of six timepoints. We view particular promise in the finding that NCX-470 demonstrated a statistically greater proportion of subjects with an at least 10 mmHg reduction versus the baseline, compared to latanoprost at multiple time points including month 3 (ranging from 69% to 46% in the NCX-470 group, compared to 60% to 34% in the latanoprost group). This finding may provide NCX-470 with a stronger competitive profile in glaucoma or OHTN cases where patients do not reach their target IOP with their existing first-line therapy. In addition, NCX-470’s NO-donating and possible retinal cell effects could be a further differentiator. Hence, we continue to believe that NCX-470 has the potential to generate $245m in net US sales in 2032, although we recognise that this is above the range communicated by the company.
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Research: Healthcare
Sequana Medical announced that it has enrolled the first patient in the open-label cohort of its MOJAVE US Phase I/IIa study evaluating its second-generation Direct Sodium Removal (DSR) product, DSR 2.0. MOJAVE is designed to assess the safety and efficacy of DSR 2.0 in diuretic-resistant chronic heart failure (CHF) patients with persistent congestion across two cohorts. Sequana expects to report initial data from the three-patient, open-label cohort by year-end 2023, which may demonstrate proof-of-concept and provide an early efficacy signal of DSR 2.0’s potential as a disease-modifying CHF treatment.