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Remplir US regulatory application on track for submission in Q4...

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rae915

4,786 Posts.

176

26/09/24

01:51

Post #: 75841471

Originally posted by saltland: ↑
Another magic trick would be great to see!

The upcoming quarter looks like it could be a productive one with the following Remplir related catalysts which should create some additional media (and investor) interest:
Top-line results from Remplir™ US market authorisation study expected in Q4 CY24
Singapore product registration in Q4 CY24
Remplir US regulatory application on track for submission in Q4 CY24
Possible distribution partner(s) for Remplir (ASEAN & U.S. or global) in Q4 CY24, otherwise Q1 CY25; possibly with upfront payment(s) for a market that has around 5x the TAM of Striate+
Side note: Promisingly, it looks like OCC are targeting a 50:50 revenue split with the distribution partner(s); compared with what looks like around 30:70 with BioHorizons. My miscalculations below based on what I thought were helpful but disregarded slides:
STRIATE+ TAM (US$) PERCENTAGE OF TARGETED MARKET WHOLESALE REVENUE @ 20% MARKET SHARE
AU/NZ (JUL-21) $34,000,000 4.6% $1,852,861
USA (JUNE-22) $300,000,000 40.9% $16,348,774
EU/UK (SEPT-23) $180,000,000 24.5% $9,809,264
CAN (JUL-24) $35,000,000 4.8% $1,907,357
BRZ $65,000,000 8.9% $3,542,234
SGP ~ ASEAN MARKET $6,000,000 0.8% $326,975
JAP $114,000,000 15.5% $6,212,534
TOTAL $734,000,000 100% $40,000,000

Implied Revenue Split? 20% x TAM = $147M BH: 70% OCC: 30%

107M/147M 40M/147M
22/6/22 - BIOHORIZONS EXCLUSIVE GLOBAL AGREEMENT FOR STRIATE+: US$16M UPFRONT PAYMENT

REMPLIR TAM (US$) PERCENTAGE OF TARGETED MARKET WHOLESALE REVENUE @ 20% MARKET SHARE
AU/NZ (NOV-22) $35,000,000 1.0% $3,355,753
SGP ~ ASEAN MARKET $7,000,000 0.2% $671,151
USA $1,602,000,000 45.9% $153,597,596
CAN $75,000,000 2.1% $7,190,899
THA $85,000,000 2.4% $8,149,685
EU/UK $1,022,000,000 29.3% $97,987,979
BRZ $421,000,000 12.0% $40,364,911
JAP $247,000,000 7.1% $23,682,026
TOTAL $3,494,000,000 100% $335,000,000

Implied Revenue Split? 20% x TAM = $700M NEW PARTNER(S): 50% OCC: 50%

365M/700M 335M/700M
Higher revenue split than Striate+due to higher product price, reimbursement & gross profit margin?
Australian reimbursement approval granted for Remplir at AU$1,354 per unit in November 2022
Axoguard US reimbursement 2024 - Physician: $765, Outpatient Facility: HOPD = $6354, ASC =$4288

axoguard nerve connector® reimbursement guide

I think it should be noted that the upcoming financial results in October sounds promising too:
"1Q FY25 displaying strong growth and ahead of expectations" - August 2024 Presentation
"We also alluded to the fact that we had a July and August revenue, well above expectations" - JVDW
“In seven quarters, we’ve had 9% CAGR up quarter on quarter, and we don’t expect that to slow down. In fact, we expect it to increase as we bring on new regulatory approvals. And what we’ve just proven with Canada, it was about eight weeks until we got our first sale, so we expect the exponential growth now to speed up” - JVDW
"First sales for Striate+, for use in dental guided bone and tissue regeneration, have quickly followed the recent regulatory approval from Health Canada in early July, demonstrating the rapid conversion from approval into sales and revenue generation in new markets" = additional revenue stream from 1Q FY25

For entertainment purposes only, I plugged my misinterpretation of the above commentary into a chart (that you may recognise since I based it off ~~one of your charts~~ company receipts) showing the exponential trendlines to see what might it look like when July and August revenues are "well above expectations":

Expand
Remplir US regulatory application on track for submission in Q4 CY24

This other procudt...Renerve is already got FDA approval...any thoughts on comparison.?

Last edited by rae915: Yesterday, 01:51

OCC Price at posting: 44.5¢ Sentiment: None Disclosure: Held

3 Upvote

0 Great analysis

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Remplir US regulatory application on track for submission in Q4...

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STRIATE+	TAM (US$)	PERCENTAGE OF TARGETED MARKET	WHOLESALE REVENUE @ 20% MARKET SHARE
AU/NZ (JUL-21)	$34,000,000	4.6%	$1,852,861
USA (JUNE-22)	$300,000,000	40.9%	$16,348,774
EU/UK (SEPT-23)	$180,000,000	24.5%	$9,809,264
CAN (JUL-24)	$35,000,000	4.8%	$1,907,357
BRZ	$65,000,000	8.9%	$3,542,234
SGP ~ ASEAN MARKET	$6,000,000	0.8%	$326,975
JAP	$114,000,000	15.5%	$6,212,534
TOTAL	$734,000,000	100%	$40,000,000

Implied Revenue Split?	20% x TAM = $147M	BH: 70%	OCC: 30%
		107M/147M	40M/147M
22/6/22 - BIOHORIZONS EXCLUSIVE GLOBAL AGREEMENT FOR STRIATE+: US$16M UPFRONT PAYMENT

REMPLIR	TAM (US$)	PERCENTAGE OF TARGETED MARKET	WHOLESALE REVENUE @ 20% MARKET SHARE
AU/NZ (NOV-22)	$35,000,000	1.0%	$3,355,753
SGP ~ ASEAN MARKET	$7,000,000	0.2%	$671,151
USA	$1,602,000,000	45.9%	$153,597,596
CAN	$75,000,000	2.1%	$7,190,899
THA	$85,000,000	2.4%	$8,149,685
EU/UK	$1,022,000,000	29.3%	$97,987,979
BRZ	$421,000,000	12.0%	$40,364,911
JAP	$247,000,000	7.1%	$23,682,026
TOTAL	$3,494,000,000	100%	$335,000,000

Implied Revenue Split?	20% x TAM = $700M	NEW PARTNER(S): 50%	OCC: 50%
		365M/700M	335M/700M
Higher revenue split than Striate+due to higher product price, reimbursement & gross profit margin?
Australian reimbursement approval granted for Remplir at AU$1,354 per unit in November 2022
Axoguard US reimbursement 2024 - Physician: $765, Outpatient Facility: HOPD = $6354, ASC =$4288

Remplir US regulatory application on track for submission in Q4...

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