Exagen Inc. (Nasdaq: XGN), a leading provider of autoimmune
testing solutions, today reported financial results for the quarter
ended June 30, 2022.
Second Quarter Highlights:
- Recognized total revenue of $9.0 million for the second quarter
of 2022. Our flagship AVISE® CTD test, including AVISE® Lupus,
recognized revenue of $7.2 million for the second quarter of
2022.
- Delivered a record 34,919 AVISE® CTD tests, including AVISE®
Lupus, in the second quarter of 2022, a 5% increase over the second
quarter of 2021 and a 13% increase over the first quarter of 2022.
Since the launch of AVISE® CTD in 2012 through the second quarter
of 2022, we have delivered over 680,000 of these tests.
- Achieved record number of ordering healthcare providers
totaling 2,273 in the second quarter of 2022, including a record of
797 adopters for the AVISE® CTD and AVISE® Lupus tests.
Additionally, we delivered sequential quarterly retention rate of
approximately 99% among adopting healthcare providers from the
prior quarter.
“Exagen once again set records in the second quarter for the
number of adopters, ordering healthcare providers and AVISE® CTD
volume. The CAPSTONE study publication in the Journal of Managed
Care & Specialty Pharma was a major milestone for Exagen as it
illustrates the superior utility and cost savings of the AVISE®
Lupus test relative to the current standard of care. With the payor
additions of Centene, WellCare, MediNcrease and Alivio, we now have
nearly 100 million in-network lives under contract. Additionally,
our research and development team continues to advance AVISE® RADR,
with the launch of our clinical experience program study today,"
said Ron Rocca, President and Chief Executive Officer of
Exagen.
Second Quarter 2022 Financial Results
Testing revenue was $9.0 million for the second quarter of 2022,
compared to $12.5 million in the second quarter of 2021, primarily
due to a decrease in AVISE® CTD revenue of $3.2 million. The
decrease in AVISE® CTD revenue was primarily due to (i) a decrease
in average reimbursement per AVISE® CTD test, (ii) a net negative
adjustment associated with changes in estimated variable
consideration related to performance obligations satisfied in
previous periods and (iii) uncertainty of the outcome of certain
claims, which have been deemed fully constrained. Our revenue
resulting from the Janssen Agreement contributed no revenue in the
second quarter of 2022, compared to $0.3 million in the second
quarter of 2021. Total revenue for the three months ended
June 30, 2022 was $9.0 million, compared with $12.8 million in
the second quarter of 2021. Gross margin was 32.2% in the second
quarter of 2022, compared to 57.3% in the second quarter of 2021,
primarily due to a decrease in revenue as described above. Testing
gross margin was 32.2% in the second quarter of 2022, compared to
56.3% in the second quarter of 2021.
Operating expenses were $21.7 million in the second quarter of
2022, compared with $18.5 million in the second quarter of 2021,
due to increases in employee related expenses from headcount
growth, including stock-based compensation and recruitment
expenses, research and development expenses, and cost of revenue
due to the increase in testing volumes.
For the second quarter of 2022, net loss was $13.3 million,
compared to a net loss of $6.4 million for the second quarter of
2021.
Cash and cash equivalents were $76.4 million as of June 30,
2022.
2022 Guidance
For the full year 2022, due to uncertainty in Medicare
reimbursement, Exagen revises its guidance and expects revenue to
be in the range of $35 million to $40 million.
Conference Call
A conference call to review second quarter 2022 financial
results and to provide a business update is scheduled for today
August 4, 2022 at 4:30 PM Eastern Time (1:30 PM Pacific Time).
Interested parties may access the conference call by dialing (404)
267-0369 (U.S.) or (888) 437-3179 (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 Thursday, August 18, 2022 at 11:59 PM Eastern Time
(8:59 PM Pacific Time). Interested parties may access the replay by
dialing (201) 612-7415 (U.S.) or (877) 660-6853 (international)
using passcode 13731768. A link to the replay of the webcast will
also be available in the investor relations section of Exagen's
website.
About Exagen
Exagen (Nasdaq: XGN) is a leading provider of autoimmune
diagnostic, prognostic, and monitoring testing solutions. Exagen is
a patient focused, discovery driven organization built on the
success of AVISE testing and is investing in its product pipeline
to support patients throughout their autoimmune diagnosis and
treatment journeys. The goal at Exagen is to assist patients,
physicians, and payors by enabling precision medicine. Exagen is
located in San Diego County with clinical and research and
development laboratories in Vista, CA.
For more information, please visit Exagen.com and follow
@ExagenInc on Twitter.
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 and any related potential
cost-savings; evaluations and interpretation of study results; the
expectation that Exagen's in-network agreements will drive
availability of its tests, and potential revenue that may be
generated by such agreements; Exagen's ability to obtain and
maintain consistent reimbursement for its tests, including its
reliance on third parties to process and transmit claims to payors
and the adverse impact of any delay, data loss, or other disruption
in processing or transmitting such claims; the expected impact and
results of further investments in its business and collaborations,
Exagen's future potential growth and ability to continue to sustain
success; and 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
its business, financial condition and results of operations,
including as a result of slowdown in its operations as well as
those of its 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 its tests causing an increase in cost per test,
its sales and commercialization activities and its ability to
receive specimens and perform or deliver the results from its
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 its tests; Exagen’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;
Exagen’s ability to successfully execute on its business
strategies; third-party payors not providing coverage and adequate
reimbursement for Exagen’s testing products or promoted
therapeutics, including Exagen's ability to collect funds due;
Exagen’s ability to obtain and maintain intellectual property
protection for its testing products; regulatory developments
affecting Exagen’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:
Investors RelationsExagen Inc.Ryan
Douglasrdouglas@exagen.com760.560.1525
CompanyExagen Inc.Kamal Adawi, Chief Financial
Officerkadawi@exagen.com760.477.5514
Exagen Inc.Unaudited
Condensed Statements of Operations(in thousands,
except share and per share data)
|
|
Three Months EndedJune 30, |
|
Six Months EndedJune 30, |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
|
Revenue |
|
$ |
8,962 |
|
|
$ |
12,772 |
|
|
$ |
19,356 |
|
|
$ |
23,359 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Costs of revenue |
|
|
6,078 |
|
|
|
5,451 |
|
|
|
11,895 |
|
|
|
10,162 |
|
Selling, general and administrative expenses |
|
|
12,903 |
|
|
|
11,171 |
|
|
|
25,055 |
|
|
|
21,211 |
|
Research and development expenses |
|
|
2,689 |
|
|
|
1,892 |
|
|
|
4,793 |
|
|
|
3,295 |
|
Total operating expenses |
|
|
21,670 |
|
|
|
18,514 |
|
|
|
41,743 |
|
|
|
34,668 |
|
Loss from operations |
|
|
(12,708 |
) |
|
|
(5,742 |
) |
|
|
(22,387 |
) |
|
|
(11,309 |
) |
Interest expense |
|
|
(606 |
) |
|
|
(663 |
) |
|
|
(1,204 |
) |
|
|
(1,308 |
) |
Other income (expense),
net |
|
|
5 |
|
|
|
(5 |
) |
|
|
10 |
|
|
|
(2 |
) |
Net loss |
|
$ |
(13,309 |
) |
|
$ |
(6,410 |
) |
|
$ |
(23,581 |
) |
|
$ |
(12,619 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.78 |
) |
|
$ |
(0.38 |
) |
|
$ |
(1.39 |
) |
|
$ |
(0.84 |
) |
Weighted-average number of
shares used to compute net loss per share, basic and diluted |
|
|
17,058,516 |
|
|
|
16,928,613 |
|
|
|
17,025,636 |
|
|
|
14,946,935 |
|
Exagen Inc.Unaudited
Condensed Balance Sheets(in thousands, except
share and per share data)
|
|
June 30, 2022 |
|
December 31,2021 |
Assets |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
76,387 |
|
|
$ |
99,442 |
|
Accounts receivable, net |
|
|
9,590 |
|
|
|
9,654 |
|
Prepaid expenses and other current assets |
|
|
3,062 |
|
|
|
3,638 |
|
Total current assets |
|
|
89,039 |
|
|
|
112,734 |
|
Property and equipment,
net |
|
|
7,216 |
|
|
|
4,772 |
|
Operating lease right-of-use
assets |
|
|
5,338 |
|
|
|
— |
|
Goodwill |
|
|
5,506 |
|
|
|
5,506 |
|
Other assets |
|
|
625 |
|
|
|
433 |
|
Total assets |
|
$ |
107,724 |
|
|
$ |
123,445 |
|
Liabilities and
Stockholders' Equity |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
|
$ |
3,105 |
|
|
$ |
2,492 |
|
Operating lease liabilities |
|
|
979 |
|
|
|
— |
|
Accrued and other current liabilities |
|
|
5,489 |
|
|
|
6,826 |
|
Total current liabilities |
|
|
9,573 |
|
|
|
9,318 |
|
Borrowings-non-current
portion, net of discounts and debt issuance costs |
|
|
27,828 |
|
|
|
27,478 |
|
Non-current operating lease
liabilities |
|
|
5,027 |
|
|
|
— |
|
Deferred tax liabilities |
|
|
306 |
|
|
|
306 |
|
Other non-current
liabilities |
|
|
810 |
|
|
|
1,407 |
|
Total liabilities |
|
|
43,544 |
|
|
|
38,509 |
|
Commitments and
contingencies |
|
|
|
|
Stockholders' equity: |
|
|
|
|
Preferred stock, $0.001 par value; 10,000,000 shares authorized, no
shares issued or outstanding at June 30, 2022 and December 31,
2021 |
|
|
— |
|
|
|
— |
|
Common stock, $0.001 par value; 200,000,000 shares authorized at
June 30, 2022 and December 31, 2021; 16,258,807 and 16,164,994
shares issued and outstanding at June 30, 2022 and December
31, 2021, respectively |
|
|
16 |
|
|
|
16 |
|
Additional paid-in capital |
|
|
295,885 |
|
|
|
293,060 |
|
Accumulated deficit |
|
|
(231,721 |
) |
|
|
(208,140 |
) |
Total stockholders' equity |
|
|
64,180 |
|
|
|
84,936 |
|
Total liabilities and
stockholders' equity |
|
$ |
107,724 |
|
|
$ |
123,445 |
|
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