Attached files
| file | filename |
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| 8-K - 8-K - Intersect ENT, Inc. | d922889d8k.htm |
| EX-99.2 - EX-99.2 - Intersect ENT, Inc. | d922889dex992.htm |
Exhibit 99.1
Intersect ENT Reports First Quarter 2015 Results
Revenue Increased 78% Year Over Year to $13.4 Million
MENLO PARK, Calif.—May 6, 2015— Intersect ENT, Inc. (NASDAQ:XENT), a company dedicated to improving the quality of life for patients with ear, nose and throat conditions, today reported financial results for the first quarter ended March 31, 2015.
Recent Highlights
| • | Achieved revenue growth of 78% over Q1 2014. |
| • | Realized gross margin of 79% versus 69% in Q1 2014. |
| • | Patient enrollment for both the RESOLVE II study and the PROGRESS study continues to proceed according to plan. RESOLVE II is a pivotal Phase III clinical study of the company’s RESOLVE steroid releasing implant designed to treat patients with recurrent sinus obstruction in the office setting. The PROGRESS study is designed to assess the safety and efficacy of the PROPEL® mini steroid releasing sinus implant when placed in the frontal sinus opening. |
| • | Added Chas McKhann as chief commercial officer and Kieran Gallahue and W. Anthony Vernon as members of the Board of Directors. Mr. Gallahue was recently CEO of CareFusion and Mr. Vernon was recently CEO of Kraft Foods, Inc. |
“We are off to a strong start in 2015, continuing to drive physician use of our PROPEL products and advancing our pipeline with on-plan enrollment in both clinical trials,” stated Lisa Earnhardt, president and CEO of Intersect ENT. “We believe that these accomplishments, together with the recent additions to our leadership team and expansion of our sales force and clinical teams, position us well for the future.”
First Quarter Financial Results
Revenue for the three months ended March 31, 2015 increased by 78% to $13.4 million from $7.5 million in the same period in 2014. This increase is attributable to higher unit sales via the acquisition of new accounts, driving adoption with existing customers, and a modest price increase
implemented at the start of the year. Gross margin for the first quarter of 2015 was 79%, up from 69% in the three months ended March 31, 2014. This increase in gross margin was due primarily to spreading the company’s manufacturing costs over higher production volumes.
Operating expenses for the first quarter of 2015 were $15.9 million, an increase of 73% compared to $9.2 million in the first quarter of 2014. The increase in operating expenses was driven primarily by growth in headcount, notably in sales and clinical staffing, an increase in clinical trial spending, as well as expenses associated with being a public company.
Net loss for the first quarter of 2015 was $5.3 million, compared to $4.4 million for the first quarter of 2014. First quarter 2015 basic and diluted net loss per share was $(0.23) per share.
Cash, cash equivalents and short-term investments totaled $42.9 million as of March 31, 2015.
Conference Call
Intersect ENT will host a conference call today at 4:30 p.m. ET to discuss its first quarter 2015 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 1-866-652-5200 and ask to join the Intersect ENT call. International callers may access the live call by dialing 1-412-317-6060.
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 10063386. 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, Inc. is dedicated to improving the quality of life for patients with ear, nose and throat conditions. The company markets two steroid releasing implants, PROPEL and PROPEL mini, clinically proven to improve surgical outcomes for patients with chronic sinusitis undergoing ethmoid
sinus surgery. In addition, Intersect ENT is developing new steroid releasing implants designed to provide ENT physicians with even more customized options to treat patients with chronic sinusitis less invasively and more cost effectively. Chronic sinusitis is an inflammatory condition leading to debilitating symptoms and chronic infections, and is one of the most costly conditions to U.S. employers.
Forward-Looking Statements
The statements in this press release regarding Intersect ENT’s continued growth and positioning for the future are “forward-looking” statements. These forward-looking statements are based on Intersect ENT’s current expectations and inherently involve significant risks and uncertainties. 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 include, without limitation: the performance of PROPEL and PROPEL mini and the investigational RESOLVE drug releasing sinus implant relative to alternative treatments may not be as Intersect ENT expects; the development of competitive products; the uncertain timing of, completion of and success of clinical trials; market competition; as well as other risks detailed from time to time in Intersect ENT’s filings with the Securities and Exchange Commission, including its Form 10-K filed on March 11, 2015. 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.
Jeri Hilleman, 650-641-2105
ir@intersectENT.com
Intersect ENT, Inc.
Condensed Statements of Operations
(in thousands, except percentages and per share data)
(unaudited)
| Three Months Ended March 31, |
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| 2015 | 2014 | |||||||
| Revenue |
$ | 13,372 | $ | 7,497 | ||||
| Cost of sales |
2,792 | 2,360 | ||||||
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| Gross profit |
10,580 | 5,137 | ||||||
| Gross margin |
79 | % | 69 | % | ||||
| Operating expenses: |
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| Selling, general and administrative |
12,620 | 6,658 | ||||||
| Research and development |
3,326 | 2,577 | ||||||
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| Total operating expenses |
15,946 | 9,235 | ||||||
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| Loss from operations |
(5,366 | ) | (4,098 | ) | ||||
| Interest and other income (expense), net |
28 | (311 | ) | |||||
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| Net loss |
$ | (5,338 | ) | $ | (4,409 | ) | ||
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| Net loss per share, basic and diluted |
$ | (0.23 | ) | $ | (2.49 | ) | ||
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| Weighted average common shares used to compute net loss per share, basic and diluted |
23,488 | 1,773 | ||||||
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Intersect ENT, Inc.
Condensed Balance Sheets
(in thousands)
(unaudited)
| March 31, 2015 |
December 31, 2014 |
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| Assets |
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| Current assets: |
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| Cash, cash equivalents and short-term investments |
$ | 42,906 | $ | 48,443 | ||||
| Accounts receivable, net |
7,998 | 8,337 | ||||||
| Inventory |
2,826 | 2,547 | ||||||
| Prepaid expenses and other current assets |
1,268 | 951 | ||||||
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| Total current assets |
54,998 | 60,278 | ||||||
| Property and equipment, net |
1,779 | 1,474 | ||||||
| Other non-current assets |
1,149 | 1,201 | ||||||
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| Total assets |
$ | 57,926 | $ | 62,953 | ||||
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| Liabilities and Stockholders’ Equity |
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| Current liabilities: |
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| Accounts payable |
$ | 1,974 | $ | 2,128 | ||||
| Accrued compensation |
4,294 | 5,085 | ||||||
| Other current liabilities |
878 | 898 | ||||||
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| Total current liabilities |
7,146 | 8,111 | ||||||
| Deferred rent |
1,098 | 1,030 | ||||||
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| Total liabilities |
8,244 | 9,141 | ||||||
| Total stockholders’ equity |
49,682 | 53,812 | ||||||
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| Total liabilities and stockholders’ equity |
$ | 57,926 | $ | 62,953 | ||||
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