reports
- Sean Conroy
OpGen - Fisher deal broadens US commercialization opportunity
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 runw...
- Sean Conroy
OpGen - Expansion of FIND R&D collaboration
OpGen has announced the expansion of its initial R&D agreement (signed in September 2022) with FIND, a global non-profit alliance for diagnostics, with potential revenue of €830k, roughly €130k higher than previous management guidance. Under the expanded scope as part of the ongoing feasibility stage for the Unyvero A30 RQ platform, OpGen will provide three additional deliverables: Antimicrobial Stewardship module, a ‘Data everywhere’ concept and next-generation sequencing (NGS) strain analysis....
- Sean Conroy
OpGen - Interim milestone achieved for R&D collaboration
OpGen has announced the achievement of two interim milestones as part of its research project (PREPLEX) in collaboration with InfectoGnostics (a research campus for diagnosis of infectious diseases and pathogens) under Jena University, Germany. The initial joint R&D project, announced in September 2020, aims to develop AI-based assay for phenotypic carbapenemase resistance in Gram-negative bacteria. Completion of the interim milestones is related to the identification of novel markers for phenot...
- Sean Conroy
OpGen - Forecasts reset ahead of busy 2023
OpGen’s FY22 update reflected a busy period for the company following the FY22 preliminary update in January 2023. Top-line performance continued to be affected by longer sales cycles, although the year was marked by traction across the company’s business units. Operating losses rose to $34.6m in FY22, affected by a $12.3m impairment recognized for goodwill and in-process R&D. The adjusted operating loss of $22.2m was an improvement over the FY21 figure of $23.1m, supported by tighter control of...
- Sean Conroy
OpGen - FY22 wrap offers key operational takeaways
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, ...
- Sean Conroy
OpGen - New public offering to support funding needs
After completing the 1:20 share consolidation, OpGen has announced a $7.5m equity issue to be closed by 11 January 2023. As part of the offering, OpGen will issue 2.6m common shares (or pre-funded warrants) at $2.90 per share, along with a similar number of Series A-1 and A-2 warrants. The warrants will be exercisable immediately at a strike price of $2.65 per share with respective expiry dates of five years and 18 months. OpGen plans to use the funds raised to accelerate commercialization effor...
- Sean Conroy
OpGen - Near-term adjustments with outlook unchanged
OpGen’s valuation case rests on its ability to develop and commercialize its suite of differentiated diagnostic products, focused on combating anti-microbial resistance (AMR). Q322 was marked by several developments on this front (see our last note), albeit offset with market caution in the current macroeconomic environment. This resulted in revised FY22 guidance (revenue of $2.5–3.0m versus c $4.6m previously) with the Q322 results. The delayed sales cycle conversions, along with the regulatory...
- Sean Conroy
OpGen - Test menu expansion opportunity with positive data
OpGen has announced encouraging final data from its Unyvero Urinary Tract Infection (UTI) panel, a diagnostic test designed to detect pathogens and antimicrobial resistance markers related to UTI, from native urine specimens without the need for culturing. The study, which recruited over 1,800 patient samples across four trial sites in the United States, met its primary endpoint with an overall weighted average sensitivity of 96.4% and specificity of 97.4% in preliminary analysis. The favourable...
- Sean Conroy
OpGen - Guidance revision triggered by softer Q322
OpGen’s Q322 revenues of $0.4m missed consensus estimates (following a strong Q222 performance), with management attributing the softness to longer than expected sales cycles for ARES and lower Unyvero A50 sales in international markets. Encouragingly though, the quarter was marked by business advancements – signing a second Acuitas AMR Gene Panel commercial contract, completing the UTI test panel patient enrollment in the US, launching ARES sequencing services in the US and announcing collabora...
- Sean Conroy
OpGen - Broadening its commercial footprint in Q322
The penultimate quarter of FY22 for OpGen was marked by tangible progress in advancing its pipeline, although revenue realization was lower than anticipated at c $0.4m in Q322 (attributed to a lower-than-expected contribution from ARES). Key milestones achieved during the quarter were the signing of a second commercial contract for the Acuitas AMR Gene Panel, completion of patient enrollment for the UTI test panel in the US, launch of ARES sequencing services in the US and collaborations with FI...
- Sean Conroy
OpGen - Rapid detection collaboration with BioVersys
OpGen has announced a collaboration agreement with Swiss pharma company, BioVersys, for the use of the Unyvero platform in screening patients for the enrollment of BioVersys’ upcoming Phase II clinical trial of drug candidate BV100. Unyvero’s HPN panel, an integrated sample-to-answer pneumonia cartridge, will be used for detecting a range of pathogens and AMR markers in hospitalized pneumonia patients. This collaboration expands the utilization of the Unyvero platform and OpGen’s overall franchi...
- Sean Conroy
OpGen - Unyvero UTI panel approaching final readouts
OpGen has completed patient sample enrollment in its prospective multicenter trial for the Unyvero urinary tract infection (UTI) panel in the United States, taking the company closer to commercializing another Unyvero test panel, following the lower respiratory tract infection (LRT) and the LRT bronchoalveolar lavage tests in 2018 and 2019, respectively. OpGen reported that more than 1,800 samples have been collected across four sites in the United States as part of the study, exceeding the FDA-...
- Sean Conroy
OpGen - $3.38m raised through private placement
OpGen has announced a $3.38m (gross) fund-raising through a private placement to an existing healthcare-focused institutional investor. This is in exchange for a combined 9.66m of common stock and pre-funded warrants at $0.35/unit plus an additional 33.8k shares of series C preferred stock. The investor was also issued warrants to purchase up to an aggregate of 9.66m in common stock, at an exercise price of $0.377/share. The offer is expected to close on 3 October 2022 and is subject to sharehol...
- Sean Conroy
OpGen - Unyvero A30 RQ collaboration with FIND
OpGen has announced an R&D collaboration with FIND (a global non-profit alliance for diagnostics) and the German KfW bank for its Unyvero A30 RQ platform for pathogen identification (ID) and antimicrobial resistance (AMR testing) using blood culture samples. Phase I of the R&D collaboration will involve a feasibility study, expected to conclude by end Q123. FIND will invest €700k in the study with the option to extend the collaboration, including a potential commercialisation agreement in low- a...
- Sean Conroy
OpGen - Addressing AMR with next-generation sequencing
OpGen has announced the launch of its next-generation sequencing (NGS) services in the United States at its new Rockville-based service laboratory. The NGS lab, developed by its subsidiary Ares Genetics, offers short-turnaround genome sequencing of clinical isolates, artificial intelligence (AI) powered outbreak analysis that can be conveniently accessed through the company’s AREScloud web application. The closer proximity to a large US customer base allows OpGen to better leverage its Ares Gene...
- Sean Conroy
OpGen - Re-acceleration with momentum in the back half
OpGen’s Q222 revenue growth re-accelerated with the post-pandemic normalization in demand. Revenues of $0.97m increased 19% y-o-y, largely driven by strength in its core offering, Unyvero. Management announced several notable wins that provide momentum to close the back half of the year strong, including the signing of two commercial Acuitas AMR Gene Panel contracts, extension of the Unyvero distribution agreement with Menarini in Europe, new distribution agreements in the Middle East and Kosovo...
- Sean Conroy
OpGen - Another collaboration agreement for Ares Genetics
OpGen’s subsidiary, Ares Genetics, has signed a research collaboration agreement with the Belgian National Reference Center (BNRC) for invasive Streptococcus pneumoniae at the university hospital Leuven. Under the agreement, the partners will evaluate the utility of Ares Genetics’ next-generation sequencing platform, machine learning tools and bioinformatics to identify and characterize Streptococcus pneumoniae for diagnostic purposes. This agreement marks Ares Genetics’ second collaboration wit...
- Sean Conroy
OpGen - A catalyst-rich Q222
OpGen provided a business update including preliminary top-line Q222 results. Quarterly revenues of $1.0m increased 23.2% y-o-y from $0.8m in Q121 and 113% from the previous quarter. Management highlighted several key developments, including the first commercial contract for the Acuitas AMR Gene Panel, extension of the existing distribution agreement with European distribution partner Menarini, a new distribution agreement with Leader Life Sciences for UAE and Qatar, and an at-the-market (ATM) s...
- Sean Conroy
OpGen - Expanding presence in the Middle East
OpGen has announced plans to commercialize its Unyvero portfolio in the United Arab Emirates and Qatar through a new distribution agreement with Leader Life Sciences (LLS). This approach is similar to the company’s European roll-out, leveraging local networks to expand and strengthen Unyvero’s presence. Regulatory approval/product registration will be required in both markets before product launch, which will be initiated and managed by LLS. The three-year distribution agreement can be extended ...
- Sean Conroy
OpGen - Clinical peer-review supports the HPN panel
A recent peer-review in The Lancet Respiratory Medicine recapped the effectiveness of the Unyvero Hospitalized Pneumonia (HPN) panel in identifying gram-negative bacteria, leading to a reduction in use and duration of inappropriate antibiotic therapy in combination with antibiotic stewardship. This large, clinical investigator-initiated, multi-center, randomized, controlled and interventional study was conducted between May 2017 to September 2019 at two tertiary care centers in Switzerland (Univ...
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