Orthocell Limited

ASX:OCC

Orthocell Limited

ASX:OCC
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$1.015 (+1.5%)
Last close price
#70
Rank
14
Held by
36
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Reports (2) My Report Forum Investors
Forum Topics OCC OCC Bear Case

Pinned straw:
laoshi
Added 5 months ago

The SP has fallen back over recent months to a more sensible level from its frothy highs and received a bump today on the back of the announcement of the first US surgery using Remplir.

Some concern in online discussion about the length of time from approval to first use and no information on sales. Shows how biotech has long lead times and will be interesting to see sales figures in the 2nd half of the year.

Largest holding in SM and held in RL
mikebrisy
Added 5 months ago

@laoshi I actually thought that three months between FDA approval and first procedure is pretty good.

There are several steps a medical devices firm has to take after gaining FDA approval.

  • First is the process of appointing the distributors and registering the device with them.
  • Second, is then developing the packaging and labelling information in line with the requirements of the FDA approval.
  • Then, there is the process of onboarding the distributor, including training of staff.
  • Next pricing has to be determined with the payor organisations
  • And usually, and this can take the longest period of time, the medical device will have to be approved by the hospital VAC (valued analysis committee) which assess the healthcare economics of using the device.
  • logistics and inventory management, then needs to be set up
  • And finally, surgeons have to be trained.


This whole process typically takes anywhere from 3 to 12 months. So the three month timeframe that $OCC has experienced, is at the very fastest end of the expected time scale. This means that they almost certainly leveraged a key opinion leader surgeon to adopt the product in the shortest possible timeframe. The wider rollout will take the best part of the rest of this year and into early next year.

From my perspective, the announcement indicates that $OCC are moving rapidly in the US.

I’m likely be unable to see the webinar on the 2nd July (travelling in Europe at the moment.) So hopefully another StrawPerson will be able to report back.

Disc. Held

16
laoshi
Added 5 months ago

Thanks for that info @mikebrisy. I managed to catch the second half of the investor webinar and now feel very positive about the progress.

Other recent announcements of a record $2.73M in revenue for the June quarter (without revenue from US Remplir) with over 200 surgeons now using Remplir and Executive appointments of CFO and CCO.

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Profitability expected in the next 2 years but with a focus on revenue. 5 staff in the US in addition to the 14 distributors.

Slides show clear images of problems with sutures in nerve repair and other devices and benefit of Remplir.

Remplir has been sent to Ukraine and used mainly for nerve capping in amputations.

Stockhead interview with US Navy Captain and Harvard Professor Ian Valerio in Australia for education events explains benefits of Remplir.


15
laoshi
Added 5 months ago

A quick summary of the Investor Webinar from Bedger on HC
JDW:
28% growth (? – 22.8%) in revenue OZ, NZ, Singapore [Remplir] and wider international mkt’s Striate.
No loyalty liability => higher margins
Already sunken $80 million in costs to get to where it is i.e. ready to go commercially
Higher revenue growth over cost growth => profit
[falling] Variable cost in distribution will see revenues exceed costs
PA:
First US surgical use [Remplir] just 3 months after FDA approval
[I agree his ‘outstanding’ opinion]
Sale ramp up in next couple of quarters
14 [Remplir] distributors on US East Coast mkts (25 states); 100 reps on ground
Control over logistics; 2,000 units shipped and ready to go
Well advanced in US Hospital procurement approvals and day surgeries
“Parity in pricing globally” [obviously with reference to US medical politics]
More on US logistics, storage, etc being all set up and ready to go
Surgical feedback on scientific narrative – merits of Remplir, nerve mimicking, negates need for sutures, handling qualities, reduction in surgical time, predictable outcomes
85% 2-year function improvement outcomes discussed
Recent study of Remplir vs suture control: earlier return to function, improved function, etc
ðPart of medical education for KOL’s and new surgeons.
ð206 surgeons in 100+ hospitals – wider areas of vascular, etc.

Discusses Axogen etc, and product inferiority – lack of degrading and handling qualities, etc. Superiority of Remplir over

Sales & Manufacturing discussed; MDR approval, just in time delivery, etc:

Hybrid sales models – internal sales team working with 14 distributors
Train representatives via 5 direct sales appointments
Dr Valerio discussion – key educator and advocate for US mkt place
Humanitarian delivery to Ukraine via an unnamed defence forcefor use in amputations
EU, UK and Brazil submissions lodged for 2H 2025 approval (?)
JDW:
9% growth rates for 3 years, anticipated to increase
Balances cash flow with growth; threshold of significant growth
Q&A:
Sales revenue expected in H1 2026:
Not making forward projections – will see revenue [growth] over next few quarters
Distributors:
Concentrating on existing distributors, but expects to double, but focusing on 14 at hand
US patience reimbursement:
Political wishy-washy answer
Distribution vs future deal:
Basically, if a future deal comes online, distribution can be dissolved – not inhibited on a future deal; larger revenues in place in US to negotiate a better deal
When other approved Remplir mkts:
Singaporean sales – Thailand/Canada/HK footprint quicker by faster approvals than expected
Main game and focus are US
The usual cash raise question (what is it with these people, can they not do basic financial analysis?):
JDW basically dispelled “we have enough”; sunk costs already there; “no we are not looking to raise any cash and have adequate resources”
Manufacturing location:
US will be more expensive – Oz best location and appropriate; COG’s etc.
[good on them]
When will Orthocell be profitable [see my comment above]:
Growth over profitability but under 2 years

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