The Anteotech Ltd (ASX: ADO) share price is falling in early trading this morning. This comes after the research and development company released its quarterly activities and earnings update.
Shares in Anteotech are now changing hands at 23.5 cents apiece, which is a 2.08% drop from yesterday's close.
Here we cover the central points in Anteotech's performance for the period ending 30 September 2021.
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Anteotech share price cools as regulatory approvals heat up
The company outlined several investment highlights it had achieved this quarter, including:
- Progress on achieving Australian regulatory approvals including ISO 13485 certification and TGA submission for EuGeni Reader and SARS-CoV-2 Ag rapid diagnostic test (RDT);
- Expansion of Life Science international distribution network to include 9 distributors across 17 territories;
- Addition of two new independent directors to its board;
- Established and held first meetings of clinical and energy advisory boards;
- Four new provisional product patent applications launched;
- Appointed three new executives after the quarter ended to enhance its marketing capability; and
- Continues to develop market entry strategy for EuGeni.
What happened this quarter for Anteotech?
It was a period of regulatory momentum for Anteotech. It received ISO 13485 certification and completed submissions to the Therapeutic Goods Association (TGA) for its EuGeni Reader and Covid-19 RDT.
For reference, ISO 13485 certification means the company has established an effective quality management system as it relates to safety and efficacy of medical devices.
It's a 6-step process, and receiving the certification is essential before commercialisation of medical devices. It ensures products are designed, manufactured and distributed to Australian standards.
As such, Anteotech is currently "finalising the regulatory requirements for the EuGeni platform in a number of European countries and in Australia".
This momentum was supported by efforts in expanding the company's Life Science international distribution network to now cover 17 countries using 9 distributors of its products.
Anteotech also managed to advance its product development further this quarter. It achieved a "full technical transfer of test design and scaled manufacturing to a third party in Europe", alongside the ISO 13485 audit.
The company also appointed three new executives, including Tim Pritchard as CFO.
These appointments are "the first of a number of new executives that herald an increased focus on product and market elements" for the company.
All in all, it was a quarter earmarked by significant advancements in the regulatory domain. This ultimately is another step towards full commercialisation of its EuGeni and AnteoX products.
However, the update hasn't fired up investors, with the Anteotech share price falling from market open.
What did management say?
Addressing shareholders on the EuGeni platform, Anteotech CEO Derek Thompson said:
Whilst the success of the project has delivered considerable value to the company, the profile of achievement for a new legal manufacturer entrant to the IVD industry can only be measured against industry benchmarks. In the IVD industry, the average time to deliver a fully operational multi-test platform and distribution network from scratch is five to seven years at an average cost of $US34m. EuGeni has been built and delivered in a fraction of that time and cost.
What's next for Anteotech?
Anteotech's key focus areas are centred around commercialising its EuGeni platform, according to its release.
It also hopes to "expand its international Life Science distribution network and complete country-level regulatory approvals".
Additionally, it hopes to continue building on market entry into the US for EuGeni after seeking regulatory approval there. It will also concurrently work to commercialise AnteoX.
Anteotech share price snapshot
Despite a 13% decline this past month, the Anteotech share price has soared by around 120% this year to date. It has also gained around 140% in the last 12 months.
That's well ahead of the benchmark S&P/ASX 200 Index (ASX: XJO)'s return of around 25% in that time.
