MENLO PARK, Calif.--(BUSINESS WIRE)--May 6, 2019--
Intersect ENT®, Inc. (NASDAQ:XENT), a company
dedicated to transforming care for patients with ear, nose and throat
conditions, today reported financial results for the first quarter ended
March 31, 2019.
Total revenue was $26.7 million for the first quarter of 2019 compared
to $24.7 million for the same period of 2018, an increase of 8%. This
increase resulted primarily from growth in adoption of the PROPEL®
family of products and from adoption of SINUVA®, which
contributed $0.9 million, or 4% of first quarter 2019 revenue.
“We continue to work closely with physicians on the introduction of
SINUVA and are pleased with the positive feedback regarding patient
outcomes,” said Lisa Earnhardt, president and CEO of Intersect ENT.
“While we have made strides in facilitating product access and sales
force balance, we are implementing further measures to continue to
improve these areas. We are encouraged by the preliminary decision by
CMS to assign a J code, and remain excited about the opportunity for
SINUVA.”
Gross profit for the quarter was $22.0 million and gross margin was 83%,
compared to gross profit of $19.2 million and gross margin of 78% for
the same period of 2018. This increase in gross profit reflects a charge
related to SINUVA taken in the first quarter of 2018 and favorable
impact in the first quarter of 2019 related to a lower cost structure
and a higher average selling price for the PROPEL family of products.
Operating expenses for the first quarter of 2019 were $33.5
million, compared to $25.8 million in the same period of 2018, an
increase of 30%. R&D expenses increased to $6.3 million from $4.3
million, primarily due to an increase in headcount and related expenses,
and expenses related to our investigational ASCEND drug-coated sinus
balloon. SG&A expenses increased to $27.2 million from $21.5 million,
primarily due to the expansion of SINUVA commercial and market access
activities including headcount, marketing and consulting expenses.
The balance of cash, cash equivalents and short-term investments was
$97.6 million, compared to $100.8 million at the start of the year.
Outlook
Intersect ENT is updating its outlook for revenue for the full year 2019
revenue to $113 to $117 million compared to prior guidance of $123 to
$127 million, and for modest growth in the second quarter. The company’s
outlook for 2019 gross margin remains in the range of 80% to 81%. In
consideration of the change in revenue outlook, the company is reducing
its outlook for operating expenses excluding stock-based expense, which
are expected to be offset by incremental stock-based expense associated
with the leadership transition announced May 6, 2019. Thus the company
is maintaining its outlook for 2019 operating expenses in the range of
$135 to $137 million.
Webcast and Conference Call Information
Intersect ENT will host a conference call at 4:30 p.m. ET (1:30 p.m. PT)
to discuss the company’s first quarter 2019 results and business
outlook. To access the conference call via the internet, go to the
"Investor Relations" page of the company's web site at www.intersectENT.com.
To access the live conference call via phone, dial 1-844-850-0548 and
ask to join the Intersect ENT call. International callers may access the
live call by dialing 1-412-317-5205. Participants may expedite telephone
access by pre-registering for the call using the following link: http://dpregister.com/10130111.
A replay of the conference call may be accessed that same day after 8:00
p.m. ET at www.intersectENT.com or
via phone at 1-877-344-7529 or 1-412-317-0088 for international callers.
The reference number to enter the replay of the call is 10130111. The
dial-in replay will be available for a week after the call and via the
internet for approximately one month.
About Intersect ENT®
Intersect ENT is dedicated to transforming ear, nose and throat care by
providing innovative, clinically meaningful therapies to physicians and
patients. The company’s steroid releasing implants are designed to
provide mechanical spacing and deliver targeted therapy to the site of
disease. In addition, Intersect ENT is continuing to expand its
portfolio of products based on the company’s unique localized steroid
releasing technology and is committed to broadening patient access to
less invasive and more cost-effective care.
For additional information on the company or the products including
risks and benefits please visit www.IntersectENT.com.
For more information about SINUVA, please visit www.SINUVA.com.
Intersect ENT®, PROPEL® and SINUVA® are
registered trademarks of Intersect ENT, Inc.
Forward-Looking Statements
The statements in this press release regarding Intersect ENT's continued
growth and financial outlook are "forward-looking" statements. These
forward-looking statements are based on Intersect ENT's current
expectations and inherently involve significant risks and uncertainties.
These statements and risks include Intersect ENT's ability to provide
solutions to improve surgical outcomes, Intersect ENT’s ability to
expand the use and adoption of its current products and advance its
pipeline, Intersect ENT’s ability to obtain and maintain FDA or other
regulatory approvals, the ability to procure and maintain adequate
coverage and reimbursement for our products and/or the procedures in
which they are used, and Intersect ENT’s projections about 2019 full
year and second quarter revenue, gross margin and operating expenses.
Actual results and the timing of events could differ materially from
those anticipated in such forward-looking statements as a result of
these risks and uncertainties, which are described in the company's
filings on Form 10-K, Form 10-Q and the company's other filings with
the Securities and Exchange Commission (SEC) available at
the SEC's Internet site (www.sec.gov).
Intersect ENT does not undertake any obligation to update
forward-looking statements and expressly disclaims any obligation or
undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein.
XENT-F
|
Intersect ENT, Inc. |
Condensed Consolidated Statements of Operations
|
(in thousands, except percentages and per share data) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
|
|
2019 |
|
2018 |
Revenue
|
|
$
|
26,673
|
|
|
$
|
24,723
|
|
Cost of sales
|
|
|
4,645
|
|
|
|
5,482
|
|
Gross profit
|
|
|
22,028
|
|
|
|
19,241
|
|
Gross margin |
|
|
83 |
% |
|
|
78 |
% |
|
|
|
|
|
Operating expenses:
|
|
|
|
|
Selling, general and administrative
|
|
|
27,207
|
|
|
|
21,516
|
|
Research and development
|
|
|
6,266
|
|
|
|
4,273
|
|
Total operating expenses
|
|
|
33,473
|
|
|
|
25,789
|
|
Loss from operations
|
|
|
(11,445
|
)
|
|
|
(6,548
|
)
|
Interest income and other, net
|
|
|
640
|
|
|
|
412
|
|
Net loss
|
|
$
|
(10,805
|
)
|
|
$
|
(6,136
|
)
|
|
|
|
|
|
Net loss per share, basic and diluted
|
|
$
|
(0.35
|
)
|
|
$
|
(0.21
|
)
|
|
|
|
|
|
Weighted average common shares used to compute net loss per share,
basic and diluted
|
|
|
30,918
|
|
|
|
29,878
|
|
|
|
|
|
|
|
|
|
|
|
Intersect ENT, Inc. |
Condensed Consolidated Balance Sheets |
(in thousands) |
(unaudited) |
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
|
2019 |
|
2018 |
Assets |
|
|
|
|
Current assets:
|
|
|
|
|
Cash, cash equivalents and short-term investments
|
|
$
|
97,586
|
|
$
|
100,773
|
Accounts receivable, net
|
|
|
17,331
|
|
|
19,616
|
Inventory
|
|
|
13,916
|
|
|
11,586
|
Prepaid expenses and other current assets
|
|
|
2,372
|
|
|
2,695
|
Total current assets
|
|
|
131,205
|
|
|
134,670
|
Property and equipment, net
|
|
|
5,975
|
|
|
5,878
|
Other non-current assets
|
|
|
1,861
|
|
|
413
|
Total assets
|
|
$
|
139,041
|
|
$
|
140,961
|
|
|
|
|
|
Liabilities and Stockholders' Equity |
|
|
|
|
Current liabilities:
|
|
|
|
|
Accounts payable
|
|
$
|
4,240
|
|
$
|
6,202
|
Accrued compensation
|
|
|
13,180
|
|
|
12,281
|
Other current liabilities
|
|
|
2,674
|
|
|
1,250
|
Total current liabilities
|
|
|
20,094
|
|
|
19,733
|
Other non-current liabilities
|
|
|
200
|
|
|
234
|
Total liabilities
|
|
|
20,294
|
|
|
19,967
|
Total stockholders' equity
|
|
|
118,747
|
|
|
120,994
|
Total liabilities and stockholders' equity
|
|
$
|
139,041
|
|
$
|
140,961
|
|
|
|
|
|
|
|

View source version on businesswire.com: https://www.businesswire.com/news/home/20190506005728/en/
Source: Intersect ENT, Inc.
Intersect ENT, Inc.
Jeri Hilleman, 650-641-2105
ir@intersectENT.com