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BioPorto has announced the appointment of Anthony Pare and Neil Goldman as its new CEO and CFO, respectively, with effect from mid-November 2021. In addition, Thomas Magnussen, chairman of the Board of Directors, has decided to step down from his position, with vice chairman Christopher Lindop taking over. We note that both the CEO and CFO are US-domiciled and view these appointments as strategic given the company’s increasing focus on the US market as it inches closer to the completion of clini
Companies: BioPorto A/S (0JJM:LON)BioPorto A/S (BIOPOR:CSE)
Edison
BioPorto has reported its results for Q121, which included DKK5.6m in sales from all its research use only products. This is up from Q120 (DKK4.2m) but comparable to Q119 (DKK5.5m). The biggest near-term driver for the company’s revenue will be the pending results of its pivotal paediatric acute kidney injury (AKI) clinical study, which is slated to complete in summer 2021, and the subsequent regulatory submission to the FDA for De Novo 510(k) clearance.
BioPorto managed to continue sales growth for its NGAL research-use only (RUO) product in 2020 despite the headwinds of COVID-19. Sales of the product increased 28% over the prior year (DKK13.4m from DKK10.5m) despite the disruption. We are encouraged to see this growth as we expect physicians with exposure to the test to become the first customers after the launch of the approved NGAL Test for clinical use.
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BioPorto has started 2021 firing on all cylinders as it prepares to resubmit its application to the FDA for the paediatric NGAL Test for detecting acute kidney injury (AKI) in summer 2021. This should set it up for a clearance decision in H221, after which it plans to submit the application for the adult NGAL Test. Concurrent with this, the company is initiating clinical testing of its COVID-19 dipstick. It expects this testing to be complete in early 2021 and emergency use authorisation (EUA) t
With its Q320 earnings, BioPorto announced that its COVID-19 antigen test it has under development would be entering the clinic. The gathering of samples is expected to start imminently and to be complete by the end of December 2020. The company believes that this timeline supports the potential commercialisation of the product in early 2021, if the results of the study are compelling.
Companies: BioPorto A/S
BioPorto reported a major increase in Q220 sales for the NGAL research use only (RUO) test, to DKK5.0m, up from DKK3.8m in Q219. This is the single highest quarter for NGAL RUO sales, and uptake in the US has been especially strong, up 95% y-o-y. Sales for the company’s other products were down (DKK1.7m, from DKK4.0m in Q219) reflecting the company’s shift in focus to NGAL. Although RUO NGAL sales remain relatively small, they represent the beachhead for the eventual launch of the FDA-cleared NG
BioPorto announced in its Q120 earnings update that the timeline for submission of its paediatric NGAL Test would be delayed to H220 (from previous guidance of Q220) on account of COVID-19. The planned clinical study to investigate the test for risk assessment of acute kidney injury (AKI) has been put on hold due to the ongoing pandemic. This will also delay the submission of the adult NGAL Test as it was planned to occur after the paediatric submission.
BioPorto has announced a collaboration with the University of Southern Denmark (SDU) to develop a point-of-care (PoC) test for the detection of COVID-19. The test would employ the company's existing generic Rapid Assay Device (gRAD) platform for POC tests, but would require the development of anti-COVID-19 antibodies, which is being done at SDU.
BioPorto Diagnostics reported sales of DKK26.6m for 2019, driven in the largest part by sales of The NGAL test for research purposes (DKK11.6m). The company reported 9% growth in NGAL Test sales year-on-year for the US (DKK4.9m) and 9% growth as a whole, representing increasing interest in the technology. The company remains on track to submit a De Novo 510(k) application for the paediatric NGAL Test in mid-2020.
Following an interaction with the FDA, BioPorto announced on 18 November 2019 that it will need to gather more data to complete the 510(k) application for the paediatric NGAL Test. The company expects this process to take several months and to resubmit its application in Q220. The feedback from the FDA has implications relating to the ongoing adult NGAL study, which is now expected to be submitted after the paediatric application (pushed back from Q419).
BioPorto announced the decision to supplement its 510(k) paediatric application with additional data, rather than withdraw it. The FDA’s decision relating to The NGAL Test’s use in the risk assessment of acute kidney injury (AKI) in paediatric populations is expected by year end. In addition, the adult AKI programme is on track with expected FDA submission by year end. Our valuation is DKK993m (DKK5.67 per basic share).
In July 2019 BioPorto announced that the FDA had requested additional information for The NGAL Test’s 510(k) application for paediatric acute kidney injury (AKI), although few other details were disclosed. Unfortunately, the existing clinical data set does not include the requested information, so the company will need to withdraw its current application and collect additional samples, which carries additional risk (probability of success lowered to 50% from 60%). The company forecasts that it w
BioPorto announced that it had submitted an application to the FDA for the paediatric NGAL Test. The application was specifically for the risk assessment of acute kidney injury in children under the age of 21. The application was submitted with breakthrough designation, which we consider very encouraging. The designation shortens the statutory review time to 45 days (from 90) and provides that a portion of data needed be provided after marketing clearance.
Research Tree provides access to ongoing research coverage, media content and regulatory news on BioPorto A/S. We currently have 0 research reports from 1 professional analysts.
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Cavendish
Verici’s $8.2m gross raise means the company can now focus on scaling Tutivia and invest further into the development of existing and new products. With a uniquely well balanced Tutivia test, a growing sales team and LCD coverage expected later this year, we forecast Tutivia revenues of $2.6m/$4.5m in FY24E/FY25E. The Thermo Fisher deal was a huge validation of Clarava and Verici’s technology and in addition to licensing/milestone payments, we forecast double digit royalties on net Clarava sales
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Singer Capital Markets
26th March 2024 @HybridanLLP Status of this Note and Disclaimer This document has been issued to you by Hybridan LLP for information purposes only and should not be construed in any circumstances as an offer to sell or solicitation of any offer to buy any security or other financial instrument, nor shall it, or the fact of its distribution, form the basis of, or be relied upon in connection with, any contract relating to such action. This document has no regard for the specific investment object
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Hybridan
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Turner Pope Investments
SkinBioTherapeutics has reported on the 6-months to December 2023, noting steady revenue growth from lead product AxisBiotix-Ps, progress on the development of SkinBiotix with partner Croda (Sederma) and post-period end, the acquisition of Dermatonics. The company has updated on several positive developments through the start of 2024, including AxisBiotix Acne positive interim results, initiation of research on the MediBiotix Pillar and progress with the oral and inflammation programmes. The com
Companies: SkinBioTherapeutics Plc
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The Hardman & Co Healthcare Index (HHI) has been running since 2009. Its main function is to highlight the attractions of life sciences investments over the long term. For the second year running, apart from global economic influences affecting world markets, performance in 2023 was dented by the capital-intensive nature of the sector. The HHI fell 3.7%, to 483.8, underperforming the main London markets – FTSE 100 (+3.8%) and FTSE All-Share (3.8%) but outperforming the FTSE AIM All-Share Index (
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Hardman & Co
On 18th December 2023 Incanthera announced a deal with Marionnaud in Switzerland to distribute ‘Skin+CELL’, its advanced dermatological solution for the delivery of vitamin B3 for skin protection and cosmetic rejuvenation. This gives Incanthera access to a high-end cosmetics distribution presence in Europe, and in addition, ownership of Marionnaud by AS Watson, the largest cosmetics distributor in Asia, offers significant new market opportunities further afield.
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Stanford Capital Partners
FY EBITDA and EBIT came in materially above consensus FY EBITDA came in at EUR98.8m, down 4% yoy and 12% above consensus. The EBITDA margin was 12.6%. Restated for one-off costs, it was 13.1%, more than 2 percentage points above the guidance. It was fully explained by price increases, notably on X-ray, mix and control of fixed costs. FY EBITA came in at EUR38m, 46% above consensus. 2024 guidance looks conservative Guerbet is aiming for organic growth above 8% (8.8%e). With markets growing at
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BNP Paribas Exane - Sponsored Research
IRLAB Therapeutics has confirmed the FDA’s alignment with its proposed Phase III programme for mesdopetam in levodopa-induced dyskinesias (PD-LIDs), following receipt of the minutes from its end-of-Phase II (EoP2) meeting held last month. Notably, the FDA has agreed on the primary endpoint being the Unified Dyskinesia Rating Scale (UDysRS), on which mesdopetam demonstrated a statistically significant improvement (p=0.026) in the Phase IIb study (secondary endpoint of that study). IRLAB will now
Companies: Irlab Therapeutics Ab
Tissue Regenix has reported on strong performance through 2023, noting record revenues driven by product adoption and expanded distribution, positive adjusted EBITDA for the first time and an increased cash position versus H1/23. FY23 revenues grew 20% to $29.5m supported by 25% growth from BioRinse products and 17% growth from dCELL products. Significantly, Tissue Regenix reported its first adjusted EBITDA profit for the year, +$0.9m, supported by revenue growth and cost management. We expect t
Companies: Tissue Regenix Group plc
Creo Medical has published a trading update for the 12 months to December 2023, during which the company focused on commercialising its core technology. Revenue for the period increased 13% YoY to £30.8m, while the underlying operating loss improved to £16.4m. Operationally, during the period, the number of confirmed users of Creo’s Speedboat range more than doubled over the year, the first procedures with MicroBlate Flex to ablate lung tumours were performed and Creo expects to receive regulato
Companies: Creo Medical Group Plc
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LungLife AI is a medical diagnostics company focused on the development of AI-supported blood-based tests for the early detection of lung cancer. It has identified a significant medical need for non-invasive, sensitive and specific tests in early-stage lung cancer. The company’s core technology, the LungLB test, seeks to detect circulating tumour cells (CTCs) to identify malignant lung nodules. It aims to apply machine learning/AI (ML/AI) to derive algorithms to increase test accuracy. Following
Companies: LungLife AI, Inc.
This month's feature article is entitled 'Gold and a Chinese Credit Event'. A Western phenomenon? If you own, or are considering owning, gold or gold equities, it’s likely that you’re concerned about protecting your wealth, or the performance of your fund, in the expectation of some kind of financial instability. Maybe your confidence in policymakers is ebbing, or you’ve researched debt bubbles in history and concluded that physical gold and silver have been the safest places to be invested whe
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