Currency in EUR
Last close As at 17/03/2023
EUR0.68
▲ −0.05 (−6.85%)
Market capitalisation
EUR38m
Research: Healthcare
Nicox has provided a preliminary Q422 update, reporting a c 38% y-o-y increase in FY22 net royalty payments to €3.3m, including a c 100% y-o-y elevation in Q422 net royalties to €1.0m. Nicox receives recurring royalty revenue from the sales of two out-licensed commercial-stage products, Vyzulta (latanoprostene bunod) and Zerviate (topical cetirizine), and we believe this yearly increase is largely due to strengthened Vyzulta-related revenue, as total US Vyzulta prescriptions grew 25% in Q422 (vs 37% in Q322 and c 40% in H122). Nicox also reiterated that it expects to report top-line results in 2025 for Denali, its second Phase III study of lead candidate NCX-470 in patients with open-angle glaucoma or ocular hypertension, and to start two Phase IIIb studies in H123, including one assessing the drug’s possible retinal health benefits. The company continues to expect that funds on hand (€27.7m at end FY22) will be sufficient to maintain operations into Q224, based on the development of NCX-470 alone.
Nicox |
Q4 highlights confirm continued Vyzulta growth |
Q422 initial results |
Pharma and biotech |
19 January 2023 |
Share price performance Business description
Analysts
Nicox is a research client of Edison Investment Research Limited. |
Nicox has provided a preliminary Q422 update, reporting a c 38% y-o-y increase in FY22 net royalty payments to €3.3m, including a c 100% y-o-y elevation in Q422 net royalties to €1.0m. Nicox receives recurring royalty revenue from the sales of two out-licensed commercial-stage products, Vyzulta (latanoprostene bunod) and Zerviate (topical cetirizine), and we believe this yearly increase is largely due to strengthened Vyzulta-related revenue, as total US Vyzulta prescriptions grew 25% in Q422 (vs 37% in Q322 and c 40% in H122). Nicox also reiterated that it expects to report top-line results in 2025 for Denali, its second Phase III study of lead candidate NCX-470 in patients with open-angle glaucoma or ocular hypertension, and to start two Phase IIIb studies in H123, including one assessing the drug’s possible retinal health benefits. The company continues to expect that funds on hand (€27.7m at end FY22) will be sufficient to maintain operations into Q224, based on the development of NCX-470 alone.
Year end |
Revenue |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/20 |
14.4 |
(10.2) |
(0.30) |
0.0 |
N/A |
N/A |
12/21 |
8.6 |
(15.5) |
(0.35) |
0.0 |
N/A |
N/A |
12/22e |
5.2 |
(17.3) |
(0.33) |
0.0 |
N/A |
N/A |
12/23e |
7.3 |
(17.4) |
(0.34) |
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.
As stated in a previous note, we believe that positive Mont Blanc NCX-470 Phase III results bode well for the drug’s likelihood of obtaining FDA approval (which we forecast in 2027) and that the Denali study is likely to lead to similar results. To strengthen NCX-470’s positioning, Nicox is aiming to build on previously reported preclinical retinal data to help demonstrate that, in addition to lowering intraocular pressure (IOP), NCX-470 may improve retinal perfusion and/or retinal cell health and thereby provide a supplemental therapeutic benefit in patients with glaucoma. The company is planning to start two clinical studies in H123, with one trial aiming to assess the drug’s effects on retinal blood flow using OCT-angiography the other assessing its ability to reduce episcleral venous pressure and enhance aqueous humor outflow through the trabecular meshwork.
As part of Nicox’s arrangement with Vyzulta global licensee Bausch + Lomb, it is entitled to tiered net royalties of 6–12% on net sales, which takes into account the Vyzulta-related royalties that Nicox must pay to Pfizer. Nicox has not yet reported FY22 gross royalties (or gross revenue) or the amount of royalty revenue it paid to Pfizer in FY22, but we note that in FY21 it paid €1.35m in royalties to Pfizer (€1.52m in FY20).
Nicox reported gross cash of €27.7m at 31 December 2022 (vs €25.6m at end September), boosted by the €10m (€8.9m net) private placement announced last November. Its debt position is little changed as it reported gross debt of €20.5m at end FY22, consisting of €18.7m Kreos Capital loan and €1.8m French State-guaranteed loan .
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Research: Healthcare
OpGen has announced preliminary FY22 results and provided a business update ahead of the detailed FY22 report expected in March 2023. Group revenue came in at $2.7m, slightly below the mid-point of the guidance range of $2.5–3.0m and 15% below our estimate. While the year was marked by several business advancements (including two Acuitas AMR Gene Panel commercial contracts, successful completion of the urinary tract infection (UTI) test panel trial, launch of ARES sequencing services in the US, and collaborations with FIND and BioVersys), top-line growth was undermined by a tough macroeconomic environment and longer sales cycles for ARES. The year-end gross cash balance stood at $7.4m and has been bolstered by the $6.8m in net proceeds raised in the January 2023 equity issue. Management estimates the combined balance will fund operations to June 2023. Our estimates and valuation are under review.
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