Here you go - other attendees can correct/add as needed:Biz...

Here you go - other attendees can correct/add as needed:

Biz status/dev/growth
- summarised recent achievements (Unitaid HIV tender order, Access Bio-AT1 device Ab test approval in US market for self-test etc); all these have opened up discussions/interest from much larger US diagnostic companies beyond the small end of the market (like current partners AccBio, NG Bio etc).

- mentioned these are significant sized companies ("multi-billion valued biz") that are interested in AT1's integrated device IP for US telehealth market (due to rising interest brought about by Coid19 testing focus + the recent device validation by US FDA EUA for the AccBio Ab test). This combined with AT1's developing digital device (Elion) + eHealth app = positioning it well for these future test/OEM partner discussions

- strongly focused on opening up US + China HIV test market (in addition to ongioing Unitaid/WHO HIV tender fulfilment); also have interest from Sth America and some Asia geos to introduce HIV self-test; mentioned Viatris is strongly focused on increasing HIV test sales in LMIC countries (as they are a key player there); Viatris has "dozens of HIV self-test applications" in progress in various countries

- continuing discussions with previously ann'd large China Diagnostics company to introduce HIV self-tests into China (+ other RDT/telehealth options)

- strong interest from AU market for Ag tests (due to Delta variant issues); aged care trials underway in many states (not just Melb/Syd); are aiming to show Federal gov that Ag RDTs combined with good infection control practices (like in US/UK health systems) provide a cost effective/timely solution that could be rolled out across this sector nationally (CEO words seem to have implied that some trials have been successfully completed and "hoping" to have discussions on this with gov?)

- summarised AT1 capacity/production scale-up (~15m annual for Galileo devices; ~10m annual for Pascal with bit more scale expected for this device);

- this production/capacity scale has helped in the large US/China partner + HIV test market discussions (as AT1 can now deliver market quantities needed); was clarified that above numbers summarise production capacity not necessarily actual production per month/qtr...depends on orders incoming/time of year (since supply chain starts in China, same chain supplies Sth Africa site for HIV devices, blister machines in US + 2nd coming online in Sydney etc)

- AU site 2nd generation blister machine setup continuing; expected to be in production later 2021

- continuing AT1 registration/division development and local biz dev time hire; who will focus on developing the ongoing discussions/interests into commercial pipeline; helps if they are working from US based company + potentially future US manufacturing site with local partners

- continuing to leverage AT1's integrated device approach in developing non-blood based tests for US/China markets (did not clarify though what medium of tests)

- awaiting Lumos Dx FebriDx approval by US FDA ("next month or two"); no problems in supply and again will assist in proving AT1's device IP to larger US blood based dx market

- discussions underway with 2 India partners (who is the 2nd one? ann'd only Divoc Health so far?) - Divoc seems to be evaluating AT1 branded Ag test now, in addition to the AT1 branded Ab test agreement; India rollout has been challenging due to India market mechanics...due to the commoditised test costs; they are working through pricing

(So India market Ab + Ag test registration seems to have been no problems? No ann has been made but this seemed to be implied in the answer above to my Q, as CEO waved aside the 'approval' portion by saying it wasn't 'approval' but more just registration using the FDA approvals per India fast track process)

- explained the digital Elion device + eHealth app dev is continuing; looking to capitalise on the emerging telehealth, digital certifications for Covid19 tests, travel certs etc..expecting to launch early 2022

- recently signed up Bondi partners reviewing opp in US market; looking to execute actions proposed in this space in 2nd Qtr FY21 (to me seems tied to the ongoing US company setup + local personnel hire to execute + have discussions)

Financial:
- due to the late FY20 FDA approval (26 June'21) AccBio initial 250k device order + due to the HIV tender order delays, initial Viatris HIV test order is booked for Q1 FY21 qtr
- which means ~500k rev will be shown in Q1 already (v good start for FY21 already)
- continuing investment in the remainder of the Pascal device capacity scale-up (~10m device annual for Pascal)
- continuing 2nd blister machine setup in Sydney
- continuing R&D in new digital + eHealth app capability and new test pipeline dev (presumably with new partners?)