NWR Virtual Investor Conference - AT1's presentation - 12.30pm AEST
Replay link:
https://us02web.zoom.us/webinar/register/WN_vWcRVTYnT1qtWEXW-7O1GA (28m 3sec)
Almost all of the presso was info that has been shared in the last half-yearly presentation. However several aspects about US market pipeline, China, Brazil, new tests, new digital device + eHealth app info were repeated and (to me) seemed more confidently stated.
Additional tidbits revealed today:
- building US market biz is a high priority, with a pipeline of products being considered/underway...and focused around delivering their chosen blend of direct branded products, OEM supply and joint partnership tests
- HIV global health tender (high volume over several years with lower margin) is imminent...considering they are 1 of 4 globally approved test + only one with integrated solution...they sounded very confident on this..
- Brazil, due to the current infection situation + slow vaccine rollout, seemed like they were discussing/planning a large Covid19 test supply agreement
- China, they are working with an established listed diagnostics company, who already has several China FDA approved products..see Q&A below for detail.
- again mentioned they are positioning themselves around Covid19 being a long term growth/test supply pillar - from infection control to post-vaccine confirmation/efficacy tests...and considering they are looking at many different markets with different test focuses, this seems to be a carefully considered, multi-year strategy being executed.
- looking to build dedicated US supply chain (for the US market) and similarly for the AU/Asia market (eg; the new Sydney blister machine being installed). They believe this will assist bring additional partners/tests in these markets & provide specific local appeal (and in my view, also position well to current gov/nationalistic views circulating in the world, avoid China politically driven bans, long distance supply chain disruptions etc)
Q&A portion starts at '17:55' in the recording..- answers are paraphrased:
1) (danhoff) NGBio partner replaced AT1's manufacturing with their own. How much of that is a concern that a partner can do this, effectively becoming a 'competitor'?
- CEO disagreed with this statement; NG Biotech always had their own strip manufacturing; AT1 supplied their device to NGBio as a (OEM) customer to finish the product and sell it; AT1 can purchase the finished product (under its own brand) whilst also continuing to supply the device only (for NGBio to sell under its own brand)..relationship is synergistic/symbiotic..as they are manufacturing part of the test (the core strip) which helps AT1 ultimately and is not a competitive relationship.
2) How is AT1's device IP is protected from another company producing a similar product?
- first company that brought device to market that focused on 'usability' rather than just the chemistry aspect; lot of their IP is about the functionality, usability and automation within an integrated device; registered at high level around the whole concept (collection of blood delivery, buffer delivery in a single device).
- Only company in the world with this integrated commercialized soln in the market;
- IP has been granted widely (AU, USA, China, Russia, Brazil, India etc) + taken 10yrs of proprietary process dev, specific, microfluidic, state of the art, blister manufacturing machine that was developed for this device.
- any competitor would need a top rate eng team and $60-70m dev money and 10yrs dev time...and it still might not be enough to get around the IP registered. AT1 has first mover advantage + bluechip customers already, which also helps in this space.
- one of the core IP components is the blister machine (current one) located in the USA, within AT1 owned premises, so its protected physically as well as intellectually.
3) Unit price of each product
- per unit price varies enormously, as its a platform based product, depending on its application/test type/market eg: HIV test retails much higher in AU (lower volume + higher margin) vs the global health tenders (with much higher volumes + lower margin).; depends on whether its OEM, finished product, own test or partner test, its an sizeable range
- AT1 wants to have a blended biz that covers own products, OEM biz, different tests, different markets, different partners,
4) US FDA rejected EUA for AT1's product last year? (was about Access Ab test approval)
- CEO corrected this, there was no rejection. App was submitted in Dec'20, its still ongoing, Access Bio confirmed the process is still ongoing and expects approval before/by 30 June'21. No objections or issues raised so far
- its common for US FDA to ask for more info, additional details...common process..similar to AU TGA locally.
- separate from the US FDA approval, Access Bio is committed to the 2m device purchase, regardless of approval status, which also speaks to their confidence of getting such approval.
5) (mine) Are you seeking US FDA approval for AT1 HIV test?
- yes, definitely considering this, especially as they have two other products in the FDA process currently (Access Bio Ab + Lumos FebriDx); good stepping stone for approval of their device, which is beneficial as they believe their HIV test is superior to the only other US consumer self-test approved so far.
6) Are you expecting more distros to be added (new/existing markets)
- referenced the China/Brazil discussions underway; number of US customers already using their product
- biz priority to grow a scalable US market; confident they will continue adding markets/tests as things develop
7) (mine) re: China, what are the timelines for regulatory approval + challenges from local competitors, costs etc- discussions underway with a large Chinese listed company, they have approved products already and hoping to 'add' AT1's device as an improvement/upgrade to their existing approved test product, rather than going through a new product application, which significantly reduces timeline.
- Awaiting further feedback, looking to get into this market in CY21
8) (mine) Since NGBio agreement is currently non-exclusive, is AT1 going to direct sell the same Ab test (under AT1 brand) into EU?
- yes, looking at number of options; selling AT1 branded Ab test direct and also discussions with (non-French) EU companies who have existing Covid19 biz. They are hoping to announce non-NGBio related biz in coming months.
9) Garbled question around finance, taken as 'need more CR or not'
- current $25m cash balance + operating costs, no need to raise funds for these aspects. if any particular biz investment/increased shareholder value situation develops, then they would consider raising funds on per case basis.