Exagen Inc. (Nasdaq: XGN), an organization dedicated to
transforming the care continuum for patients suffering from
debilitating and chronic autoimmune diseases by enabling timely
differential diagnosis and optimizing therapeutic intervention,
today reported financial results for the fourth quarter and full
year ended December 31, 2019.
Recent Highlights:
- Generated total revenue of $40.4 million for the year ended
December 31, 2019, representing 24% year-over-year growth.
- Experienced record demand for the flagship AVISE® CTD test,
including AVISE® Lupus, to over 105,000 tests in 2019, a 26%
increase over 2018.
- Grew the number of ordering healthcare providers in the fourth
quarter by 34% year-over-year to a record 1,707.
- Sequential quarter retention rate of approximately 98% among
adopting healthcare providers in the fourth quarter of 2019.
- Advanced strategic integrated testing and therapeutics strategy
(Dx/Rx) through co-promotion agreement with Janssen Biotech for
SIMPONI®, realizing approximately $1.5 million in revenue for the
year.
“The Exagen team completed a landmark year. We completed our
initial public offering in September, delivered records in both
testing volumes and ordering healthcare providers, and generated
24% revenue growth on a year-over-year basis. We are pleased with
our continued progress towards our vision to Own the Rheumatology
Hilltop,” said Ron Rocca, Exagen President and Chief Executive
Officer. "Importantly, we believe many of the building blocks for
the next phase of the Company's growth are in place heading into
the remainder of 2020."
Fourth Quarter 2019 Financial Results
Revenue for the three months ended December 31, 2019 was $10.2
million, compared with $9.6 million in the fourth quarter of
2018. Testing revenue was $9.6 million in the quarter, flat
year-over-year. While testing volume increased, this was offset by
lower average selling prices. Revenue from our co-promotion efforts
contributed $0.6 million in the quarter.
Gross margin was 55% in the fourth quarter of 2019 compared to
59% in the fourth quarter of 2018, driven by lower average selling
prices.
Operating expenses increased to $13.1 million in the fourth
quarter of 2019, compared with $9.8 million in the fourth quarter
of 2018, due primarily to an increase in selling, general, and
administrative expenses associated with our salesforce expansion
and public company expenses not present in 2018.
For the fourth quarter of 2019, net loss was $3.4 million
compared to a net loss of $1.3 million for the fourth quarter of
2018.
Cash and cash equivalents were approximately $72.1 million as of
December 31, 2019.
Full Year 2019 Financial Results
Revenue for the full year of 2019 was $40.4 million, compared
with $32.4 million in 2018. Testing revenue increased to
$38.9 million, a 20% year-over-year increase, driven by record
testing volumes in AVISE® CTD, including AVISE® Lupus. Revenue from
our co-promotion efforts contributed $1.5 million in the full year
of 2019.
Gross margins remained consistent at 53% in the full year of
2019 and 2018.
Operating expenses increased to $49.7 million in the full year
of 2019, compared with $37.3 million in the full year of 2018, due
primarily to an increase in selling, general, and administrative
expenses associated with our salesforce expansion and an increase
in costs of revenue driven by record testing volumes in AVISE® CTD,
including AVISE® Lupus.
For the full year of 2019, net loss was $12.0 million compared
to a net loss of $8.0 million for the full year 2018.
Conference Call
A conference call to review fourth quarter and year-end 2019
financial results, and to provide a business update, is scheduled
for today, March 25th, 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 Wednesday, April 1, 2020 at 11:59 PM Eastern Time
(8:59 PM Pacific Time). Interested parties may access the replay of
the conference call by dialing (844) 512-2921 (U.S.) or (412)
317-6671 (international) using passcode 13699461. 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 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 the
company’s current beliefs and expectations. Such forward-looking
statements include, but are not limited to, statements regarding:
the company’s future potential growth and vision to Own the
Rheumatology Hilltop. 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 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®; the recent outbreak
of the COVID-19 coronavirus may have a material adverse effect on
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, disrupt the
supply chain of material needed for our tests, interrupt our
ability to receive specimens, impair our ability to perform or
deliver the results from our genomic tests, impede patient movement
or interrupt healthcare services causing a decrease in test
volumes, delay coverage decisions from Medicare and third-party
payors, and delay ongoing and planned clinical trials involving our
tests; the company’s dependence on third parties for reagents,
equipment and other materials used in its testing products; 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 Registration Statement on
Form S-1 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 December 31, |
|
Year Ended December 31, |
|
|
2019 |
|
2018 |
|
2019 |
|
2018 |
|
|
(Unaudited) |
Revenue |
|
$ |
10,214 |
|
|
$ |
9,641 |
|
|
$ |
40,387 |
|
|
$ |
32,440 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Costs of revenue (excluding amortization of purchased
technology) |
|
4,591 |
|
|
4,003 |
|
|
18,808 |
|
|
15,379 |
|
Selling, general and administrative expenses |
|
7,915 |
|
|
5,256 |
|
|
28,702 |
|
|
19,675 |
|
Research and development expenses |
|
566 |
|
|
533 |
|
|
2,176 |
|
|
2,125 |
|
Amortization of intangible assets |
|
— |
|
|
— |
|
|
— |
|
|
141 |
|
Total operating expenses |
|
13,072 |
|
|
9,792 |
|
|
49,686 |
|
|
37,320 |
|
Loss from operations |
|
(2,858 |
) |
|
(151 |
) |
|
(9,299 |
) |
|
(4,880 |
) |
Interest expense |
|
(771 |
) |
|
(770 |
) |
|
(3,491 |
) |
|
(2,868 |
) |
Change in fair value of financial
instruments |
|
— |
|
|
(373 |
) |
|
267 |
|
|
(318 |
) |
Other income, net |
|
246 |
|
|
35 |
|
|
510 |
|
|
112 |
|
Loss before income taxes |
|
(3,383 |
) |
|
(1,259 |
) |
|
(12,013 |
) |
|
(7,954 |
) |
Income tax expense |
|
25 |
|
|
58 |
|
|
25 |
|
|
58 |
|
Net loss |
|
(3,408 |
) |
|
(1,317 |
) |
|
(12,038 |
) |
|
(8,012 |
) |
Accretion of redeemable
convertible preferred stock |
|
— |
|
|
(2,856 |
) |
|
(4,640 |
) |
|
(9,318 |
) |
Deemed dividend recorded in
connection with financing transactions |
|
— |
|
|
— |
|
|
(13,601 |
) |
|
(1,152 |
) |
Net loss attributable to common
stockholders |
|
$ |
(3,408 |
) |
|
$ |
(4,173 |
) |
|
$ |
(30,279 |
) |
|
$ |
(18,482 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.27 |
) |
|
$ |
(66.23 |
) |
|
$ |
(8.46 |
) |
|
$ |
(293.34 |
) |
Weighted-average number of shares
used to compute net loss per share, basic and diluted |
|
12,560,502 |
|
|
63,005 |
|
|
3,578,771 |
|
|
63,005 |
|
|
Exagen Inc.Condensed Balance
Sheets(in thousands, except share and per share
data) |
|
|
|
December 31, 2019 |
|
December 31, 2018 |
Assets |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
72,084 |
|
|
$ |
13,164 |
|
Accounts receivable, net |
|
5,715 |
|
|
5,952 |
|
Prepaid expenses and other current assets |
|
3,451 |
|
|
2,196 |
|
Total current assets |
|
81,250 |
|
|
21,312 |
|
Property and equipment, net |
|
1,380 |
|
|
1,566 |
|
Goodwill |
|
5,506 |
|
|
5,506 |
|
Other assets |
|
174 |
|
|
503 |
|
Total assets |
|
$ |
88,310 |
|
|
$ |
28,887 |
|
Liabilities, Redeemable
Convertible Preferred Stock and Stockholders' Equity
(Deficit) |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
|
$ |
1,476 |
|
|
$ |
1,279 |
|
Accrued liabilities |
|
4,419 |
|
|
3,923 |
|
Proceeds received prior to issuance of Series G redeemable
convertible preferred stock |
|
— |
|
|
3,750 |
|
Total current liabilities |
|
5,895 |
|
|
8,952 |
|
Borrowings-non-current
portion, net of discounts and debt issuance costs |
|
25,854 |
|
|
24,617 |
|
Redeemable convertible preferred
stock warrant liabilities |
|
— |
|
|
1,503 |
|
Deferred tax liabilities |
|
264 |
|
|
245 |
|
Other non-current
liabilities |
|
638 |
|
|
304 |
|
Total liabilities |
|
32,651 |
|
|
35,621 |
|
Commitments and
contingencies |
|
|
|
|
Redeemable convertible preferred
stock, $0.001 par value; none and 750,300,000 shares authorized at
December 31, 2019 and 2018, respectively; none and 532,606,084
shares issued and outstanding at December 31, 2019 and December 31,
2018, respectively; liquidation preference of $0 and $163,316 at
December 31, 2019 and December 31, 2018, respectively |
|
— |
|
|
105,232 |
|
Stockholders' equity
(deficit): |
|
|
|
|
Preferred stock, $0.001 par value; 10,000,000 shares authorized, no
shares issued or outstanding at December 31, 2019; no shares
authorized, issued or outstanding at December 31, 2018 |
|
— |
|
|
— |
|
Common stock, $0.001 par value; 200,000,000 and 1,470,000,000
shares authorized at December 31, 2019 and December 31, 2018,
respectively; 12,560,990 and 63,005 shares issued and outstanding
at December 31, 2019 and December 31, 2018, respectively |
|
13 |
|
|
— |
|
Additional paid-in capital |
|
220,248 |
|
|
40,598 |
|
Accumulated deficit |
|
(164,602 |
) |
|
(152,564 |
) |
Total stockholders' equity (deficit) |
|
55,659 |
|
|
(111,966 |
) |
Total liabilities, redeemable
convertible preferred stock and stockholders' equity (deficit) |
|
$ |
88,310 |
|
|
$ |
28,887 |
|
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