Exagen Inc. Reports Third Quarter 2020 Results
November 10 2020 - 4:05PM
Exagen Inc. (Nasdaq: XGN), an organization dedicated to
transforming the care continuum for patients suffering from
autoimmune diseases, today reported financial results for the
quarter ended September 30, 2020.
Third Quarter Highlights:
- Generated total revenue of $10.8 million for the quarter ended
September 30, 2020, an increase of 20% over the quarter ended
June 30, 2020 and 3% over the quarter ended September 30,
2019.
- Delivered 26,201 flagship AVISE® CTD tests, including AVISE®
Lupus, in the third quarter 2020 despite reduced patient visits
resulting from the COVID-19 pandemic.
- Number of ordering healthcare providers was 1,665 in the third
quarter, with a record 600 adopters, and sequential quarterly
retention rate of approximately 99% among adopting healthcare
providers from the prior quarter.
- Added to covered lives following the agreement with Humana
TRICARE East to make AVISE® testing covered and in-network for
approximately 6 million lives, and an agreement with Provider
Network of America making AVISE® in-network for 8 million
lives.
- Continued to expand our suite of comprehensive testing
solutions for rheumatologists, launching AVISE® Vasculitis
AAV.
“We're very pleased with our results in the third quarter, as
our core testing business performed well in an environment where
patients continued to have challenges visiting their healthcare
providers due to the COVID-19 pandemic. Despite these headwinds,
our testing volumes have approached the level of Q1 2020 volumes
which were only marginally affected by COVID-19. Meanwhile, our
co-promotion agreement with Janssen continues to supplement our top
line and enhance our gross margin," said Ron Rocca, President and
Chief Executive Officer of Exagen. "Throughout the quarter we
continued to position Exagen as a premier autoimmune company. Our
world-class R&D team launched a new product to build upon our
already robust portfolio. We continued to expand access to
our AVISE® franchise through payor and provider contracting. The
Exagen team delivered strong operational execution during the
quarter and took concrete strategic steps to strengthen the
business for long-term sustainable success."
Third Quarter 2020 Financial Results
Revenue for the three months ended September 30, 2020 was
$10.8 million, compared with $10.4 million in the third quarter of
2019. Testing revenue was $9.5 million for the third quarter of
2020, compared to $10.0 million in the third quarter of 2019, due
to lower testing volumes attributed to COVID-19 impacts and a
decrease in average reimbursement per test. Our SIMPONI®
co-promotion efforts contributed $1.3 million in the third quarter
of 2020, compared to $0.4 million in the third quarter of 2019.
Gross margin was 60% in the third quarter of 2020 compared to 54%
in the third quarter of 2019, benefiting from an increase in
SIMPONI® revenues and a decrease in royalty costs associated with
the expiration of a royalty on our CB-CAPs technology.
Operating expenses were $14.6 million in the third quarter of
2020, compared with $12.6 million in the third quarter of 2019, due
to increases in employee related expenses, including stock-based
compensation, and public company expenses.
For the third quarter of 2020, net loss was $4.3 million,
compared to a net loss of $3.1 million for the third quarter of
2019.
Cash and cash equivalents were approximately $61.4 million as of
September 30, 2020.
Conference Call
A conference call to review third quarter 2020 financial results
and to provide a business update is scheduled for today November
10, 2020 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
http://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, November 17, 2020 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 13711892. 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.
CB-CAPs assess the activation of the complement system, a
biological pathway that is widely implicated across many autoimmune
and autoimmune-related diseases, including systemic lupus
erythematosus, or SLE. Exagen’s goal is to enable rheumatologists
to improve care for patients through the differential diagnosis,
prognosis and monitoring of complex autoimmune and
autoimmune-related diseases, including SLE and rheumatoid
arthritis, or RA. Exagen’s model of integrating testing products
and therapeutics positions Exagen to offer targeted solutions to
rheumatologists and, ultimately, better serve patients. For
more information, please visit www.Exagen.com.
Forward Looking StatementsExagen 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 the company’s current beliefs and
expectations. Such forward-looking statements include, but are not
limited to, statements regarding: the expected impact of COVID-19;
the potential benefit of the company's testing products and
promoted therapeutic for patients and physicians in autoimmune
disease treatment; the potential to position the business for
long-term sustainable success; and the availability and use of
AVISE® tests through Humana TRICARE East and the Provider Network
of America network. 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 payers
and others in the medical community; the company’s ability to
successfully execute on its Dx/Rx strategy, including its promotion
efforts for SIMPONI®; third party payers 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 the company’s prior press releases and the
Company’s filings with the Securities and Exchange Commission
(SEC), including under the heading “Risk Factors” in the company’s
Annual Report on Form 10-K 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:
InvestorsWestwicke PartnersMike
CavanaughMike.Cavanaugh@westwicke.com646.677.1838
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 Ended September 30, |
|
Nine Months Ended September 30, |
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
|
|
|
|
|
(Unaudited) |
Revenue |
|
$ |
10,775 |
|
|
$ |
10,439 |
|
|
$ |
29,307 |
|
|
$ |
30,173 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Costs of revenue |
|
4,341 |
|
|
4,783 |
|
|
12,224 |
|
|
14,217 |
|
Selling, general and administrative expenses |
|
9,202 |
|
|
7,306 |
|
|
27,104 |
|
|
20,787 |
|
Research and development expenses |
|
1,018 |
|
|
507 |
|
|
2,403 |
|
|
1,610 |
|
Total operating expenses |
|
14,561 |
|
|
12,596 |
|
|
41,731 |
|
|
36,614 |
|
Loss from operations |
|
(3,786 |
) |
|
(2,157 |
) |
|
(12,424 |
) |
|
(6,441 |
) |
Interest expense |
|
(647 |
) |
|
(909 |
) |
|
(1,913 |
) |
|
(2,720 |
) |
Change in fair value of financial
instruments |
|
— |
|
|
(200 |
) |
|
— |
|
|
267 |
|
Other income, net |
|
125 |
|
|
125 |
|
|
985 |
|
|
264 |
|
Loss before income taxes |
|
(4,308 |
) |
|
(3,141 |
) |
|
(13,352 |
) |
|
(8,630 |
) |
Income tax benefit |
|
— |
|
|
— |
|
|
118 |
|
|
— |
|
Net loss |
|
(4,308 |
) |
|
(3,141 |
) |
|
(13,234 |
) |
|
(8,630 |
) |
Accretion of redeemable
convertible preferred stock |
|
— |
|
|
(338 |
) |
|
— |
|
|
(4,640 |
) |
Deemed dividend recorded in
connection with financing transactions |
|
— |
|
|
(13,601 |
) |
|
— |
|
|
(13,601 |
) |
Net loss attributable to common
stockholders |
|
$ |
(4,308 |
) |
|
$ |
(17,080 |
) |
|
$ |
(13,234 |
) |
|
$ |
(26,871 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.34 |
) |
|
$ |
(11.29 |
) |
|
$ |
(1.05 |
) |
|
$ |
(48.70 |
) |
Weighted-average number of shares
used to compute net loss per share, basic and diluted |
|
12,644,348 |
|
|
1,513,189 |
|
|
12,626,259 |
|
|
551,730 |
|
Exagen Inc.
Condensed Balance
Sheets(in thousands, except share and per share
data)
|
|
September 30, 2020 |
|
December 31, 2019 |
|
|
|
|
|
Assets |
|
(Unaudited) |
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
61,434 |
|
|
$ |
72,084 |
|
Accounts receivable, net |
|
9,297 |
|
|
5,715 |
|
Prepaid expenses and other current assets |
|
1,824 |
|
|
3,451 |
|
Total current assets |
|
72,555 |
|
|
81,250 |
|
Property and equipment, net |
|
1,758 |
|
|
1,380 |
|
Goodwill |
|
5,506 |
|
|
5,506 |
|
Other assets |
|
174 |
|
|
174 |
|
Total assets |
|
$ |
79,993 |
|
|
$ |
88,310 |
|
Liabilities and
Stockholders' Equity |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
|
$ |
2,454 |
|
|
$ |
1,476 |
|
Accrued and other current liabilities |
|
5,820 |
|
|
4,419 |
|
Total current liabilities |
|
8,274 |
|
|
5,895 |
|
Borrowings-non-current
portion, net of discounts and debt issuance costs |
|
26,453 |
|
|
25,854 |
|
Deferred tax liabilities |
|
147 |
|
|
264 |
|
Other non-current
liabilities |
|
645 |
|
|
638 |
|
Total liabilities |
|
35,519 |
|
|
32,651 |
|
Commitments and
contingencies |
|
|
|
|
Stockholders' equity: |
|
|
|
|
Preferred stock, $0.001 par value; 10,000,000 shares authorized, no
shares issued or outstanding at September 30, 2020 and
December 31, 2019 |
|
— |
|
|
— |
|
Common stock, $0.001 par value; 200,000,000 shares authorized at
September 30, 2020 and December 31, 2019; 12,652,113 and
12,560,990 shares issued and outstanding at September 30, 2020
and December 31, 2019, respectively |
|
13 |
|
|
13 |
|
Additional paid-in capital |
|
222,297 |
|
|
220,248 |
|
Accumulated deficit |
|
(177,836 |
) |
|
(164,602 |
) |
Total stockholders' equity |
|
44,474 |
|
|
55,659 |
|
Total liabilities and
stockholders' equity |
|
$ |
79,993 |
|
|
$ |
88,310 |
|
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