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Co-Diagnostics Inc

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FY2020 Annual Report · Co-Diagnostics Inc
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2020
ANNUAL 
REPORT

2401 South Foothill Dr, Suite D
Salt Lake City, Utah 84109

codiagnostics.com

info@codiagnostics.com

 
 
 
a letter to our 
SHAREHOLDERS

Calling 2020 the single most important 

of  diagnostics  to  help  ameliorate  its 

in  helping  to  fill  the  ongoing  need  for 

year in our Company’s history would fall 

impact.  These  included  multiplex  tests 

COVID-19 diagnostics, which is expected 

short  of  accurately  describing  how 

for  several  SARS-CoV-2  genes,  such  as 

to  remain  for  some  time  as  a  part  of 

significant a year it was for Co-Diagnostics. 

influenza  A/B  and  COVID-19,  and  the 

normalization protocols and in countries 

Along  with  everyone,  we  shared  in  the 

development  of  our  new  direct  saliva 

where vaccination rates lag substantially 

hardships 

and 

challenges 

that 

technology  to  greatly 

improve  PCR 

behind  those  of  the  United  States,  we 

accompanied  the  global  pandemic, 

throughput  by  eliminating  the  costly 

believe  this  device  has  the  potential  to 

which  tested  our  mettle  in  ways  that 

and time-consuming extraction step. All 

revolutionize  how  and  where  PCR 

were  impossible  to  foresee.  Through  it 

these  tests  have  either  CE-IVD  or  FDA 

testing is performed.

all,  our  growing  and  devoted  staff 

EUA clearance or both. 

displayed  perseverance,  commitment, 

and  dedication  to  helping  as  many 

people,  in  as  many  places,  as  possible. 

Thanks to their efforts, and the support of 

our loyal shareholder base, Co-Diagnostics 

was able to share our value proposition 

of top-of-the-line, affordable diagnostics 

across  the  globe,  as  we  proved  to  the 

world  not  only  that  our  technology  can 

compete with the best, but that we can 

execute at a high level under extremely 

difficult circumstances.

This past year was transformative for the 

Company  in  a  number  of  ways.  We 

always  believed  in  the  quality  of  our 

CoPrimer™  technology  platform  and 

proprietary design system, but it wasn’t 

until  2020  that  we  had  a  gateway  to 

introduce  this  platform  and  suite  of 

high-quality  PCR  products  to  a  wider 

audience and share its success worldwide. 

After  announcing  completion  of  the 

principal design for our novel coronavirus 

test in January 2020, we quickly moved 

to complete the necessary development 

and 

validation 

to  obtain  CE-IVD 

clearance the following month—the first 

U.S.-based  company  to  do  so  for  a 

COVID-19 diagnostic. 

Our  FDA  Emergency  Use  Authorization 

followed 

shortly 

thereafter,  greatly 

expanding  our  reach  domestically,  and 

as the pandemic grew, so did our menu 

COVID-19  has  been  just  the  beginning. 

Our  meteoric 

growth 

ultimately 

Among global trends that motivated us 

culminated  in  selling  over  10  million 

to create this new platform are the long-

tests  in  2020,  netting  the  Company  

term  and 

largely  unmet  needs  for 

$42.5  million  on  revenues  of  $74.6 

inexpensive  accurate  molecular  testing 

million—a  significantly  profitable  and 

that  can  be  performed  in  a  variety  of 

successful year.

After  such  an  eventful  year,  the  logical 

question to ask is, where do we go from 

here?  Our  robust,  debt-free  balance 

sheet and continuous cash accumulation 

have provided the resources to work on 

further building out our product menus. 

This 

includes  diagnostics 

for 

liquid 

biopsy as well as infectious diseases that 

are endemic in regions all over the world, 

and for which ready-made markets now 

exist thanks to our expanded network of 

trusted  and  valued  distributors.  Even 

more  exciting  (and,  we  believe,  more 

impactful) is our Eikon testing platform 

currently under development. 

The 

Eikon 

platform 

includes  

several  breakthrough 

technological 

advancements—including  our  direct 

saliva  extraction-free  PCR  protocol—

that have taken place over the last year 

and  represents  the  culmination  of 

efforts on the part of Co-Diagnostics and 

the  team  of  world-renowned  experts 

involved  in  its  development.  While  we 

expect  this  point-of-care  and  at-home 

testing device will have its initial impact 

settings,  from  high-throughput  CLIA 

labs to remote locations that have never 

had access to PCR-quality diagnostics. It 

is  designed  to  go  far  beyond 

just 

COVID-19  alone  and  cover  any  RNA  or 

DNA  pathogen  for  which  the  Company 

develops  an  extraction-free  single  or 

multiplex  test.  Co-Diagnostics  may  not 

be the first to take this approach, but we 

do  believe  we  will  be  the  first  to  “get  it 

right,”  as  we 

intend  to  make  the 

diagnostic  gold-standard  the  standard 

for everyone, by providing a high-quality, 

fully  integrated  and  reusable molecular 

diagnostic  platform  that  is  affordable, 

fast, and accurate.

We  are  proud  of  our  growth  and 

achievements in 2020 and so far in 2021, 

and  we  believe  the  best  is  yet  to  come 

for Co-Diagnostics, our dedicated teams, 

and our valued shareholders. Thank you 

for your continued support.

Dwight H. Egan
CHIEF EXECUTIVE OFFICER

CO -D I AG NO STICS INC.  |  202 0  ANNUAL  REP ORT

OPERATING / REVENUE

30,000,000

25,000,000

20,000,000

15,000,000

10,000,000

5,000,000

0

-5,000,000

Operating Income

Revenue

1Q20

2Q20

3Q20

4Q20

U.S. CUSTOMERS

WYOMING

NORTH DAKOTA

MONTANA

NEBRASKA

MINNESOTA

WISCONSIN

ILLINOIS

NEW YORK

OHIO

CALIFORNIA

NEVADA

UTAH

COLORADO

ALASKA

TEXAS

MISSISSIPPI

OKLAHOMA

KANSAS

TENNESSEE

FLORIDA

NEW JERSEY

MARYLAND

VIRGINIA

NORTH CAROLINA

SOUTH CAROLINA

GEORGIA

US VIRGIN ISLANDS

PUERTO RICO

WORLDWIDE CUSTOMERS

CANADA

MEXICO

GUATELMALA

HONDURAS

PANAMA

COLUMBIA

PERU

BOLIVIA

UKRAINE

TURKEY

ROMANIA

LITHUANIA

GEORGIA

SLOVIC REPUBLIC
SWEDEN

GERMANY

UK

IRELAND

FRANCE
ITALY

TUNISIA
GREECE KOSOVO
LYBIA

TURKS & CAICOS

DOMINICAN REPUBLIC

BRITISH VIRGIN ISLANDS

TRINIDAD & TOBAGO

GHANA

NIGERIA

CONGO

PAKISTAN

SAUDI ARABIA

INDIA

THAILAND

PARAGUAY

ARGENTINA

URUGUAY

SOUTH AFRICA

JORDAN

ISRAEL

PHILIPPINES

INDONESIA

AUSTRALIA