Currency in USD
Last close As at 02/06/2023
USD0.70
▲ −0.05 (−6.67%)
Market capitalisation
USD4m
Research: Healthcare
OpGen has announced a non-exclusive distribution agreement with Fisher Healthcare to market and distribute its Unyvero A50 platform and range of diagnostic assays in the United States. Although this is a departure from the company’s self-commercialization strategy for the region, we see merits in this decision, as it allows OpGen to scale market coverage while easing financial demands related to salesforce expansion. Funding is likely a key consideration for the company given the short cash runway (June 2023) and upcoming debt repayments. In another key milestone, OpGen announced the filing of the de novo application for its Unyvero urinary tract infection (UTI) panel, following encouraging data reported from the recently concluded clinical trials. If approved, we anticipate OpGen to launch the UTI panel in the United States in 2024, adding another revenue stream for the business. We also expect Fisher to distribute the UTI panel as well (once approved), which should support broader market coverage.
OpGen |
Fisher deal broadens US commercialization opportunity |
Business update |
Pharma and biotech |
20 April 2023 |
Share price performance Business description
Analysts
OpGen is a research client of Edison Investment Research Limited |
OpGen has announced a non-exclusive distribution agreement with Fisher Healthcare to market and distribute its Unyvero A50 platform and range of diagnostic assays in the United States. Although this is a departure from the company’s self-commercialization strategy for the region, we see merits in this decision, as it allows OpGen to scale market coverage while easing financial demands related to salesforce expansion. Funding is likely a key consideration for the company given the short cash runway (June 2023) and upcoming debt repayments. In another key milestone, OpGen announced the filing of the de novo application for its Unyvero urinary tract infection (UTI) panel, following encouraging data reported from the recently concluded clinical trials. If approved, we anticipate OpGen to launch the UTI panel in the United States in 2024, adding another revenue stream for the business. We also expect Fisher to distribute the UTI panel as well (once approved), which should support broader market coverage.
Year end |
Revenue |
EBITDA* ($m) |
PBT* |
EPS* |
P/E |
Net debt/(cash) |
12/21 |
4.3 |
(20.4) |
(35.7) |
(23.4) |
N/A |
(14.4) |
12/22 |
2.6 |
(20.6) |
(25.3) |
(10.4) |
N/A |
4.4 |
12/23e |
4.7 |
(17.7) |
(21.0) |
(3.8) |
N/A |
17.6 |
12/24e |
7.9 |
(15.3) |
(19.6) |
(3.6) |
N/A |
37.5 |
Note: *Figures are normalized, excluding amortization of acquired intangibles, exceptional items and share-based payments. EPS adjusted for the 1:20 share consolidation in January 2023.
Fisher Healthcare is part of Thermo Fisher Scientific and we expect OpGen to leverage Fisher’s established footprint and relationships with hospitals and diagnostic labs to expand commercial coverage of its Unyvero suite of products in the United States. We highlight that OpGen has been exclusively working with distribution partners across different geographies (including with Menarini for Europe) but had opted to self-commercialize in the United States. Following the deal with Fisher, OpGen will continue to co-commercialize in the United States, although we expect lower incremental investments in selling and marketing related activities in future. The agreement includes the distribution of OpGen’s Unyvero A50 platform and in vitro diagnostic tests for bacterial pneumonia (Unyvero LRT and LRT BAL) and its research use only test for UTI (Unyvero UTI), but we expect the deal to expand to include commercial sales of the UTI panel, once approved.
OpGen has also announced the widely anticipated de novo submission of its Unyvero UTI test panel to the US FDA. We highlight that the Unyvero UTI panel has been designed to test for a broad range of bacterial and fungal pathogens as well as antimicrobial resistance markers (25 pathogens and 15 resistance genes) directly from native urine specimens (without the need for culturing), resulting in much quicker turnaround times (four to five hours versus days in the case of culture-based tests). OpGen had reported encouraging final data from its clinical studies (assessing >1,800 patient samples), reporting an overall weighted average sensitivity of 96.4% and specificity of 97.4%. We expect approval and subsequent launch of the panel to add materially to the company’s top line. We attribute an 80% probability of approval to the panel.
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Research: Metals & Mining
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