MENLO PARK, Calif.--(BUSINESS WIRE)--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.
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.
Intersect ENT®, PROPEL® and SINUVA® are registered trademarks of Intersect ENT, Inc.
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.
|Intersect ENT, Inc.|
Condensed Consolidated Statements of Operations
|(in thousands, except percentages and per share data)|
|Three Months Ended|
|Cost of sales||4,645||5,482|
|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 per share, basic and diluted||$||(0.35||)||$||(0.21||)|
Weighted average common shares used to compute net loss per share, basic and diluted
|Intersect ENT, Inc.|
|Condensed Consolidated Balance Sheets|
|March 31,||December 31,|
|Cash, cash equivalents and short-term investments||$||97,586||$||100,773|
|Accounts receivable, net||17,331||19,616|
|Prepaid expenses and other current assets||2,372||2,695|
|Total current assets||131,205||134,670|
|Property and equipment, net||5,975||5,878|
|Other non-current assets||1,861||413|
|Liabilities and Stockholders' Equity|
|Other current liabilities||2,674||1,250|
|Total current liabilities||20,094||19,733|
|Other non-current liabilities||200||234|
|Total stockholders' equity||118,747||120,994|
|Total liabilities and stockholders' equity||$||139,041||$||140,961|