Exagen Inc. (Nasdaq: XGN), a leading provider of autoimmune
testing solutions, today reported financial results for the fourth
quarter and full year ended December 31, 2021.
Recent Highlights:
- Record total revenue of $48.3
million for the year ended December 31, 2021, and total
revenue of $12.7 million for the fourth quarter of 2021. Record
AVISE® CTD, including AVISE® Lupus, revenue of $39.2 million for
the year ended December 31, 2021, a 34.1% increase over 2020,
and revenue of $10.4 million for the fourth quarter of 2021, a
21.2% increase over the fourth quarter of 2020.
- Record 128,246 flagship AVISE® CTD
tests, including AVISE® Lupus, for the full year 2021, and a record
34,147 tests for the fourth quarter of 2021. Since the launch of
AVISE® CTD in 2012 and through 2021, we have delivered over 615,000
of these tests.
- Record number of ordering healthcare
providers totaling 2,126 in the fourth quarter of 2021, including a
record of 739 adopters, and sequential quarterly retention rate of
approximately 99% among adopting healthcare providers from the
prior quarter.
- Record full year 2021 gross margin
of $27.7 million, with a gross margin percent of 57.4%, and gross
margin of $7.8 million for the fourth quarter of 2021, with a gross
margin percent of 61.1%. Record full year 2021 testing gross margin
of $26.5 million, with a record testing gross margin percent of
56.3% (testing gross margin represents the gross margin for our
tests and excludes the effect of the Janssen Agreement), and record
testing gross margin of $7.6 million for the fourth quarter of
2021, with a record testing gross margin of 60.5%.
- Acquired exclusive worldwide license
for technology utilized in the development for AVISE® RADR
(Rheumatoid Arthritis Drug Response) platform for to enable
precision medicine in rheumatology.
“2021 was another record-breaking year for Exagen as we continue
to show our sustainable success in delivering autoimmune testing
solutions. I'm very proud of our team for continuing to drive
toward commercial excellence, building a robust pipeline, and
adding additional payors; all with the mission of being a patient
focused, discovery driven organization," said Ron Rocca, President
and Chief Executive Officer of Exagen. "We are excited for 2022,
and are proud to announce adding coverage and an in-network
agreement with WellCare and Centene Health Plans, which includes
over 22 million lives. We now have payor agreements for over 91
million in-network lives. We look forward to continued success and
development of our pipeline products, including our AVISE® RADR
platform."
Fourth Quarter 2021 Financial Results
Revenue for the three months ended December 31, 2021 and 2020
was $12.7 million. Testing revenue was $12.5 million for the fourth
quarter of 2021, a 14.2% year-over-year increase, driven by record
testing volumes in AVISE® CTD, including AVISE® Lupus. Our revenue
resulting from the Janssen Agreement contributed $0.2 million in
the fourth quarter of 2021, compared to $1.7 million in the fourth
quarter of 2020. Gross margin was 61.1% in the fourth quarter of
2021 compared to 65.8% in the fourth quarter of 2020, driven by the
decrease in revenue resulting from the Janssen Agreement. Testing
gross margin was 60.5% in the fourth quarter of 2021 compared to
60.4% in the fourth quarter of 2020.
Operating expenses were $18.9 million in the fourth quarter of
2021, compared with $15.4 million in the fourth quarter of 2020,
due to increases in employee related expenses from headcount
growth, including stock-based compensation, cost of revenue due to
the increase in testing volumes and research and development
expenses.
For the fourth quarter of 2021, net loss was $7.1 million,
compared to a net loss of $3.5 million for the fourth quarter of
2020.
Cash and cash equivalents were approximately $99.4 million as of
December 31, 2021.
Full Year 2021 Financial Results
Revenue for the full year of 2021 was $48.3 million, compared
with $42.0 million for the full year of 2020. Testing revenue
increased to $47.1 million, a 27.8% year-over-year increase, driven
by record testing volumes in AVISE® CTD, including AVISE® Lupus.
Our revenue resulting from the Janssen Agreement contributed $1.2
million for the full year 2021. Gross margin was 57.4% for the full
year of 2021 and testing gross margin was 56.3% for the full year
of 2021.
Operating expenses were $72.4 million for the full year of 2021,
compared with $57.2 million for the full year of 2020, due to
commercial and research and development investments.
For the full year of 2021, net loss was $26.9 million compared
to a net loss of $16.7 million for the full year of 2020.
2022 Guidance
For the full year 2022, Exagen expects revenue to be in the
range of $51 million to $53 million.
Conference Call
A conference call to review fourth quarter and year-ended 2021
financial results and to provide a business update is scheduled for
today March 22, 2022 at 4:30 PM Eastern Time (1:30 PM Pacific
Time). Interested parties may access the conference call by dialing
(877) 407-3982 (U.S.) or (201) 493-6780 (international).
Additionally, a link to a live webcast of the call will be
available in the Investor Relations section of Exagen's website at
investors.exagen.com.
Participants are asked to join a few minutes prior to the call
to register for the event. A replay of the conference call will be
available until Tuesday, March 29, 2022 at 11:59 PM Eastern Time
(8:59 PM Pacific Time). Interested parties may access the replay by
dialing (844) 512-2921 (U.S.) or (412) 317-6671 (international)
using passcode 13727619. A link to the replay of the webcast will
also be available in the investor relations section of Exagen's
website.
About Exagen
Exagen is dedicated to transforming the care continuum for
patients suffering from debilitating and chronic autoimmune
diseases by enabling timely differential diagnosis and optimizing
therapeutic intervention. Exagen has developed and is
commercializing a portfolio of innovative testing products under
its AVISE® brand, several of which are based on our proprietary
Cell-Bound Complement Activation Products, or CB-CAPs, technology.
Exagen’s goal is to enable providers to improve care for patients
through the differential diagnosis, prognosis and monitoring of
complex autoimmune and autoimmune-related diseases, including
rheumatoid arthritis and lupus. For further information please
visit www.Exagen.com.
Forward Looking Statements
Exagen cautions you that statements contained in this press
release regarding matters that are not historical facts are
forward-looking statements. These statements are based on Exagen’s
current beliefs and expectations. Such forward-looking statements
include, but are not limited to, statements regarding: Exagen's
goals and strategies; the potential utility and effectiveness of
Exagen's services and testing solutions that are currently
available or in its development pipeline; the ability of the
company to secure wider reimbursement for its tests; the expected
impact and results of further investments in our business and
collaborations; Exagen's future potential growth and ability to
continue or sustain success; and the 2022 guidance. The inclusion
of forward-looking statements should not be regarded as a
representation by Exagen that any of its plans will be achieved.
Actual results may differ from those set forth in this press
release due to the risks and uncertainties inherent in Exagen’s
business, including, without limitation: the COVID-19 pandemic may
continue to adversely affect our business, financial condition and
results of operations, including as a result of shutdowns of our
facilities and operations as well as those of our suppliers and
courier services, impeding patient movement and interruptions to
healthcare services causing a decrease in test volumes, disruptions
to the supply chain of material needed for our tests, our sales and
commercialization activities and our ability to receive specimens
and perform or deliver the results from our tests, delays in
reimbursement and coverage decisions from Medicare and third-party
payors and in interactions with regulatory authorities, and delays
in ongoing and planned clinical trials involving our tests; the
company’s commercial success depends upon attaining and maintaining
significant market acceptance of its testing products and promoted
therapeutics among rheumatologists, patients, third-party payors
and others in the medical community; the company’s ability to
successfully execute on its business strategies, including its
strategy of integrating the promotion of its existing and future
proprietary testing products with the promotion of therapeutics;
third-party payors not providing coverage and adequate
reimbursement for the company’s testing products or promoted
therapeutics; the company’s ability to obtain and maintain
intellectual property protection for its testing products;
regulatory developments affecting the company’s business; and other
risks described in Exagen’s prior press releases and Exagen’s
filings with the Securities and Exchange Commission ("SEC"),
including under the heading “Risk Factors” in Exagen’s Annual
Report on Form 10-K for the year ended December 31, 2021 and any
subsequent filings with the SEC. You are cautioned not to place
undue reliance on these forward-looking statements, which speak
only as of the date hereof, and Exagen undertakes no obligation to
update such statements to reflect events that occur or
circumstances that exist after the date hereof. All forward-looking
statements are qualified in their entirety by this cautionary
statement, which is made under the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995.
CONTACTS:
Investor RelationsExagen Inc.Ryan
Douglasrdouglas@exagen.com 760.560.1525
CompanyExagen Inc.Kamal Adawi, Chief Financial
Officerkadawi@exagen.com 760.477.5514
| |
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Exagen Inc. |
|
|
|
Unaudited Condensed Statements of
Operations(in thousands, except share and per
share data) |
| |
|
|
|
|
| |
|
Three Months Ended December 31, |
|
Year Ended December 31, |
|
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
(Unaudited) |
|
Revenue |
|
$ |
12,689 |
|
|
$ |
12,668 |
|
|
$ |
48,299 |
|
|
$ |
41,975 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Costs of revenue |
|
|
4,939 |
|
|
|
4,335 |
|
|
|
20,588 |
|
|
|
16,559 |
|
|
Selling, general and administrative expenses |
|
|
11,802 |
|
|
|
9,929 |
|
|
|
44,541 |
|
|
|
37,033 |
|
|
Research and development expenses |
|
|
2,202 |
|
|
|
1,165 |
|
|
|
7,237 |
|
|
|
3,568 |
|
|
Total operating expenses |
|
|
18,943 |
|
|
|
15,429 |
|
|
|
72,366 |
|
|
|
57,160 |
|
| Loss
from operations |
|
|
(6,254 |
) |
|
|
(2,761 |
) |
|
|
(24,067 |
) |
|
|
(15,185 |
) |
| Interest
expense |
|
|
(639 |
) |
|
|
(652 |
) |
|
|
(2,625 |
) |
|
|
(2,565 |
) |
| Other
income, net |
|
|
15 |
|
|
|
(1 |
) |
|
|
16 |
|
|
|
984 |
|
| Loss
before income taxes |
|
|
(6,878 |
) |
|
|
(3,414 |
) |
|
|
(26,676 |
) |
|
|
(16,766 |
) |
| Income
tax (expense) benefit |
|
|
(175 |
) |
|
|
(39 |
) |
|
|
(175 |
) |
|
|
79 |
|
| Net
loss |
|
$ |
(7,053 |
) |
|
$ |
(3,453 |
) |
|
$ |
(26,851 |
) |
|
$ |
(16,687 |
) |
| Net loss
per share, basic and diluted |
|
$ |
(0.42 |
) |
|
$ |
(0.27 |
) |
|
$ |
(1.68 |
) |
|
$ |
(1.32 |
) |
|
Weighted-average number of shares used to compute net loss per
share, basic and diluted |
|
|
16,969,614 |
|
|
|
12,652,202 |
|
|
|
15,972,256 |
|
|
|
12,632,780 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exagen Inc. |
|
|
|
Condensed Balance Sheets(in thousands,
except share and per share data) |
| |
|
|
| |
|
December 31, |
|
|
|
|
2021 |
|
|
|
2020 |
|
| Assets |
|
|
|
|
| Current assets: |
|
|
|
|
|
Cash and cash equivalents |
|
$ |
99,442 |
|
|
$ |
57,448 |
|
|
Accounts receivable, net |
|
|
9,654 |
|
|
|
8,910 |
|
|
Prepaid expenses and other current assets |
|
|
3,638 |
|
|
|
4,159 |
|
|
Total current assets |
|
|
112,734 |
|
|
|
70,517 |
|
| Property and equipment,
net |
|
|
4,772 |
|
|
|
2,102 |
|
| Goodwill |
|
|
5,506 |
|
|
|
5,506 |
|
| Other assets |
|
|
433 |
|
|
|
250 |
|
|
Total assets |
|
$ |
123,445 |
|
|
$ |
78,375 |
|
| Liabilities and
Stockholders' Equity |
|
|
|
|
|
|
|
|
| Current liabilities: |
|
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
2,492 |
|
|
$ |
3,014 |
|
|
Accrued and other current liabilities |
|
|
6,826 |
|
|
|
5,757 |
|
|
Total current liabilities |
|
|
9,318 |
|
|
|
8,771 |
|
| Borrowings-non-current
portion, net of discounts and debt issuance costs |
|
|
27,478 |
|
|
|
26,659 |
|
| Deferred tax liabilities |
|
|
306 |
|
|
|
158 |
|
| Other non-current
liabilities |
|
|
1,407 |
|
|
|
948 |
|
|
Total liabilities |
|
|
38,509 |
|
|
|
36,536 |
|
| Commitments and
contingencies |
|
|
|
|
|
|
|
|
| Stockholders' equity: |
|
|
|
|
|
|
|
|
|
Preferred stock, $0.001 par value; 10,000,000 shares authorized, no
shares issued or outstanding at December 31, 2021 and
December 31, 2020 |
|
|
— |
|
|
|
— |
|
|
Common stock, $0.001 par value; 200,000,000 shares authorized at
December 31, 2021and December 31, 2020; 16,164,994 and
12,652,308 shares issued and outstanding atDecember 31, 2021
and December 31, 2020, respectively |
|
|
16 |
|
|
|
13 |
|
|
Additional paid-in capital |
|
|
293,060 |
|
|
|
223,115 |
|
|
Accumulated deficit |
|
|
(208,140 |
) |
|
|
(181,289 |
) |
|
Total stockholders' equity |
|
|
84,936 |
|
|
|
41,839 |
|
| Total liabilities and
stockholders' equity |
|
$ |
123,445 |
|
|
$ |
78,375 |
|
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