BioPorto Diagnostics - Key leadership changes announced

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

BioPorto Diagnostics - Focused on the upcoming paediatric AKI results

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 Diagnostics - Continued growth in 2020 despite headwinds

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.

BioPorto Diagnostics - Multiple upcoming readouts

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

BioPorto Diagnostics - COVID-19 test to enter the clinic

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.

BioPorto Diagnostics - Record setting NGAL sales

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 Diagnostics - COVID-19 delays clinical studies

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 Diagnostics - BioPorto to collaborate on COVID-19 test

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 - Headed in the right direction

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.

BioPorto Diagnostics - FDA – more data needed for paediatric AKI

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 Diagnostics - Making headway towards commercialisation

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).

BioPorto Diagnostics - Paediatric AKI application pulled, Q4 resubmission

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 Diagnostics - Paediatric NGAL Test submitted with breakthrough

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.

Strong growth in core underpins FY expectations

EKF has reported a strong H1, with revenues of £37.5m and double-digit growth in underlying non-Covid related business. Management reports it is trading in line with expectations for the full year and we make no change to our profit forecasts at this stage. New growth initiatives are proceeding to plan and should lead to accelerated core growth from FY23 onwards. We continue to see substantial upside on successful execution with the shares trading on an FY23 P/E of 13.1x and an EV/EBITDA of just

Hybridan Small Cap Feast 09/08/22

Dish of the day Joiners: No joiners today. Leavers: No leavers today. What’s cooking in the IPO kitchen?** Unigel Group, intends to join the Aquis Growth Market. Unigel Group is a pioneer in the field of thixotropic gels for the fibre optic cable industry. The Company is also a supplier of laminated steel tapes to the fibre optic cable industry in the US. Thixotropic gels and laminated steel tapes are essential components to the rapidly growing global fibre optic cable market. The Group exports

Morning Note – 3 August 2022

Hybridan Small Cap Feast 16/08/22

Joiners: No joiners today. Leavers: No leavers today. What’s cooking in the IPO kitchen?** Unigel Group, intends to join the Aquis Growth Market. Unigel Group is a pioneer in the field of thixotropic gels for the fibre optic cable industry. The Company is also a supplier of laminated steel tapes to the fibre optic cable industry in the US. Thixotropic gels and laminated steel tapes are essential components to the rapidly growing global fibre optic cable market. The Group exports to over 40 count

LIBERUM: PureTech Health - Karuna hits Phase III ground running

Hybridan Small Cap Feast 05/08/22

Dish of the day Joiners: Inteliqo Limited has joined the Access Segment of AQSE Growth Market. Inteliqo Limited provides sales, marketing and distribution services to technology product owners. Leavers: Menzies (John) plc and Sanne Group have left the Premium Segment of the Main Market. What’s cooking in the IPO kitchen?** Unigel Group, intends to join the Aquis Growth Market. Unigel Group is a pioneer in the field of thixotropic gels for the fibre optic cable industry. The Company is also a sup

WHI First Light: Spectra Systems, ARC Minerals, KEFI Gold & Copper, Dekel Agri-vision, NetScientific & LifeSafe Holdings

Spectra, a leader in machine-readable high speed banknote authentication, brand protection technologies and gaming security software, has announced its first commercial sale of a Banknote Disinfection System (BDS) to an Asian central bank. The BDS system, utilising Spectra's patented technology, contributes to the safety of central bank staff who handle banknotes incoming from circulation, which may carry bacterial and viral pathogens. The system is a plug and play technology as it does not req

Morning Note – 5 August 2022

The Hardman & Co Monthly: August 2022

Feature article: Utility regulation – Changes afoot - Patching up a tainted model While the gas supply crisis – and its price implications – have dominated the UK price regulated sectors in recent months, other issues have arisen that have seriously tainted the price regulation system itself. Indeed, it is fair to ask whether it is ‘’fit for purpose’’. Back in 1984, price regulation, via an unsophisticated RPI-x formula, was introduced to prevent the privatised British Telecom (BT) from abusin

Hybridan Small Cap Feast 16/06/2022

*A corporate client of Hybridan LLP Dish of the day Joiners: No Joiners Today. Leavers: No Leavers Today. What’s cooking in the IPO kitchen? LifeSafe Holdings, a fire safety technology business with innovative fire safety products, intends to join AIM. LifeSafe has developed what the Directors believe to be market disrupting, eco-friendly fire safety protection products to both protect (via fire extinguishers) and detect (via carbon monoxide, smoke and heat alarms) fires. At the cent

WH Ireland: NetScientific (NSCI) - Portfolio company PDS Biotechnology provides a business update and Q2 2022 financial results

NetScientific is an active transatlantic life sciences, sustainability and technology investment and commercialisation group. Portfolio company, NASDAQ-listed PDS Biotechnology (PDSB), in which NSCI holds a 4.72% equity stake, announced on 8 August 2022, a business update along with Q2 2022 results to the end of June 2022.

Growth on an accelerating path

Smith & Nephew’s growth acceleration and margin expansion in Q2 should continue in H215, more reflecting internal changes than improvements in market fundamentals. Its c 13% premium on 2015 P/E to its global ortho peers is supported by its brisker growth and strategic value.

Hybridan Small Cap Feast 12-07-2022

*A corporate client of Hybridan LLP Dish of the day Joiners: Warehouse REIT (WHR.L) has transferred to AIM from the Main Market. Leavers: No leavers today. What’s cooking in the IPO kitchen? Georgina Energy, an early-stage resource company with a strategy of actively pursuing the exploration, commercial development and monetisation of helium, hydrogen and hydrocarbon interests located in the Amadeus and Officer Basins in Northern and Western Australia intends to join AIM. Georgina

Next Gen XPLOR and D2C

Belluscura has announced the launch of the next generation X-PLOR portable oxygen concentrator and expanded distribution through a D2C offering and partnership distribution plan for smaller DMEs.

Pfizer Inc.: The Biohaven Acquisition, Financial Forecasts, DCF & Comparables Valuation, ESG & Other Risks (05/22)

Pfizer had a phenomenal 2021 given the upside of the Covid-19 vaccine and medication. An estimated 1.4 billion patients have been reached by the company with its vaccines and medicines. Pfizer’s position has been upgraded from fourth to second over big bio-pharmacy companies. In R&D, its investments have been increased, and it has started 13 pivotal clinical studies. The company is increasing its investments in Covid-19 medication, Paxlovid and widening its distribution. The strength of the comp