Therma Bright Inc V.THRM

RE: Facts: Product, Marketplace/Industry, FDA-EUA &Competition

[Moemoney42]

Nice work with the calculator.. but.. if you think a small microcap that hasn't sold one test is comparable to multi billion, multi product companies, you're dreaming..! 
Not to mention those multi billion $ companies can squeeze the selling price so that any new start ups will have to price so low to attract sales, that there's no profit at all.. 
Have you ever watched a show called "Shark Tank" the minute an entrepeneur says they only need a small % of a certain big market.. the sharks jump all over them.. saying don't even go there.. that's not a plan or guarantee for profit.. the shoe fits here too.. I wish you all luck.. but lets get real.. posters don't need to justify where the stock price is heading.. the market is doing it for them.. 

Watchman21 wrote:

From a post early on another board, as to why people here should look at Product Facts, Industry & Marketplace Facts, FDA EUA Facts and Competition Fact to determine the validity of Acuvid Test and its potential for securing FDA EUA and its potential in the market place.

This is to refute all those who make subjective comments that this is going to 5cent or 10 cents.  Maybe its as high as they can count.  Don't know, but they never provide any data backing their projections.

(NOTE:  I updated some info on Quidel who posted final Q1, 2022 earning late last week https://www.medicaldevice-network.com/news/quidel-revenues-q1-2022/)

 

 

ACUVID RESEARCH:  PRODUCT PERFORMANCE

 

Acuvid tests achieve FDA EUA requirements from US (and Brazil study) per company announcement.  It also tested against variants and conducted the cross reactivity studies.

• US CLINICAL: PPA 80.3% & NPA. 98.0%.
  • Complete during Omicron and Delta

• Brazil Clinical PPA. 85.7% and 97.8 %
  • Complete June/July 2021

 

MARKETPLACE RESEARCH;  INDUSTRY FACTS & COMPETITOR SUCCESS

• Abbott made  $3.3B of $11B from Covid-19 tests Sales in Q1, 2022
  • https://abbott.mediaroom.com/2022-04-20-Abbott-Reports-First-Quarter-2022-Results
• DiaSorin reported revenues of €96.7 million for COVID-19 serology and molecular diagnostic tests,
  • https://diasoringroup.com/en/investors/financial-corner/press-releases/strong-growth-revenues-and-cash-flow-generation-q1-2022 
• Quidell made over $890M on $1B in revenues from its Q1, 2022 Profit was $740M. That's 74% profit on $1B Revenue
  • https://www.medicaldevice-network.com/news/quidel-revenues-q1-2022/
• Seimens made €329M from its Q1, 2022 Covid-19 sales
  • https://www.siemens-healthineers.com/press/releases/2022q1
• TOTAL: over $5B USD on their COVID19 test

 

These 4 companies make up 12 of the 50 COVID-19 Rapid Antigen Tests with FDA EUA. 

What revenues are the other 38 tests making?  If these 38 make $5B combined, that's $131M per test per quarter...over $500M per year with a profit margin of $250M per year (estimate 50% profit, where as Quidel had 74% profit). Today, May 13, 2022, Quidel's PE Ratio is 4.18, based on the fact 89% of its revenues came from COVID19 tests.  

If each of the 38 remaining tests were to make $250M USD [$323M CAD] profit X PE Ratio 4.0  that's a $1.00B USD [$1.292B CAD] valuation ...or $4 CAD per share on 312M shares, warrants & options.  
 

FDA RESEARCH:  FDA EUA FACTS & REQUIREMENTS

• All manufacturers have to test their device against all World Health Organizations Variants of Concern
• All manufacturers have to be able to produce a minimum of 500K test kits per week for POC or At Home
• Tests need to achieve a minimum of 80% PPA and 95%-96% NPA

 

COMPETITORS RESEARCH: COMPETITORS WITH FDA EUA

Check out the dates these all received FDA EUA.   Some during Omicron & Delta.  Others long before that.   Would Ortho and Ellume still have the same results or lower?  Even though Acuvid is lower for US study vs Brazil study in PPA, it still meets FDA EUA. Doubtful Ellume and Ortho would meet these FDA EUA standards today

 

Ortho VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack (NASAL)

Positive Percent Agreement: 80.0% (95% CI: 56.6– to 88.5%)

Negative Percent Agreement: 100.0% (95% CI: 95.2 to 100.0%)

Source:https://www.fda.gov/media/145073/download

FDA EUA GRANTED: 01/11/2021. Over 1 year ago, before Omicron & Delta

 

ellume Lab's Covid Antigen Test (NASAL)

Positive Percent Agreement: 81.8% (95% CI: 65.6% to 91.4%)

Negative Percent Agreement: 100.0% (95% CI: 93.6% to 100%)

Source: https://www.fda.gov/media/150687/download

FDA EUA GRANTED:  07/08/2021 Over 1 year ago, before Omicron & Delta

 

Xiamen Boson Biotech Co., Ltd.” Rapid SARS-CoV-2 Antigen Test Card (NASAL)

Positive Percent Agreement: 82.7% (95% CI: 71.1– to 90.4%)

Negative Percent Agreement: 99.1% (95% CI: 95.2%-99.8%)

Source:https://www.fda.gov/media/157544/download

FDA EUA Grant:  04/06/2022.  During Omicron & Delta

 

OSANG LLC OHC COVID-19 Antigen Self Test (NASAL)

Positive Percent Agreement: 82.9% (95% CI: 73.0– to 88.0%)

Negative Percent Agreement: 98.6% (95% CI: 94.4%-99.6%)

Source: https://www.fda.gov/media/157548/download

FDA EUA Grant:  04/06/2022.  During Omicron & Delta

 

DO YOUR DUE DILIGENCE

 

Learn the space, read the FDA EUA Application and website (https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2), research the performance of public competitors (such as Abbott, Diasorin, Quidel, Seimens),  Read the performance data and fact provided by THRM in public press announcements.   Do the Due Diligence And You'll see that this has some solid growth potential.