8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): January 7, 2019

Intersect ENT, Inc.

(Exact name of registrant as specified in its charter)

Delaware	001-36545	20-0280837
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)

Intersect ENT, Inc.

1555 Adams Drive

Menlo Park, California 94025

(Address of principal executive offices, including zip code)

(650) 641-2100

(Registrant’s telephone number, including area code)

Not Applicable

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company  ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

Item 2.02 Results of Operations and Financial Condition

On January 7, 2019, Intersect ENT, Inc. (the “Company”) issued a press release announcing its preliminary expectations of revenue for the fourth quarter of 2018 and the year ended December 31, 2018 as well as revenue guidance for the first quarter of 2019 and the year ending December 31, 2019. A copy of the Company press release is furnished and attached as Exhibit 99.1.

Item 7.01 Regulation FD Disclosure

Members of the Company’s management team expect to make a presentation regarding the Company (the “Presentation”) to investors and analysts and to meet with investors and analysts at the J.P. Morgan Annual Healthcare Conference between January 7, 2019 and January 10, 2019 to discuss the Presentation. A copy of the Presentation is furnished and attached as Exhibit 99.2.

The information in this Items 2.02 and 7.01 and Exhibits 99.1 and 99.2 of this Current Report on Form 8-K are being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 as amended (Exchange Act), or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (Securities Act). The information in Items 2.02 and 7.01 and Exhibits 99.1 and 99.2 shall not be deemed incorporated by reference in any filing under the Securities Act, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.	Description
99.1	Press release entitled “Intersect ENT Reports Preliminary Fourth Quarter and Full Year 2018 Revenue” dated January 7, 2019.
99.2	Presentation dated January 2019.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	Intersect ENT, Inc.
Dated: January 7, 2019
	By:	/s/ Jeryl L. Hilleman
		Jeryl L. Hilleman
		Chief Financial Officer

EX-99.1

Exhibit 99.1

Intersect ENT Reports Preliminary Fourth Quarter and Full Year 2018 Revenue

MENLO PARK, Calif.—(BUSINESS WIRE)—Jan. 7, 2019—Intersect ENT, Inc. (NASDAQ: XENT), a company dedicated to improving the quality of life for patients with ear, nose and throat conditions, today reported preliminary unaudited revenue for the fourth quarter and full year ended December 31, 2018.

Fourth Quarter and Full Year 2018 Preliminary Revenue

Preliminary unaudited revenue for the full year 2018 is expected to be in the range of $108.3 to $108.5 million, an increase of 12-13% compared to $96.3 million for 2017. Preliminary unaudited revenue for the fourth quarter of 2018 is expected to be in the range of $32.6 to $32.8 million, an increase of 11% compared to $29.5 million for the fourth quarter of 2017. These revenue ranges include preliminary SINUVA^® revenue of approximately $2.8 million for the full year 2018 and $1.2 million for the fourth quarter of 2018. The remaining revenue was comprised of sales of the PROPEL^® family of products.

The fourth quarter and full year 2018 revenue included in this release are preliminary and prior to the completion of review and audit procedures by Intersect ENT’s external auditors, and are therefore subject to adjustment. Intersect ENT expects to provide fourth quarter and full year 2018 financial results and further 2019 guidance during its fourth quarter 2018 earnings call in late February 2019.

2019 Revenue Outlook

The company forecasts full year 2019 revenue in the range of $123 to $127 million and first quarter revenue in the range of $26.0 to $26.5 million.

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 preliminary unaudited results contained in this press release and the forecasts regarding Intersect ENT’s future performance are “forward-looking” statements. These forward-looking statements are based on Intersect ENT’s current expectations and inherently involve significant risks and uncertainties and are subject to quarter-end closing adjustments. These statements and risks include Intersect ENT’s view of preliminary fourth quarter and full year 2018 revenue, including preliminary SINUVA revenue, and projections of first quarter and full year 2019 revenue. Actual results 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.

Jeri Hilleman, 650-641-2105

ir@intersectENT.com

# # #

EX-99.2

Delivering Innovation. Where It’s Needed. January 2019 Exhibit 99.2

Forward-Looking Statements Certain statements in this presentation constitute “forward-looking statements” within the meaning of the Securities Act of 1933, as amended (the “Securities Act”), and Securities Exchange Act of 1934, as amended (“Exchange Act”), including, without limitation,  statements regarding our outlook for financial performance, sales force growth, clinical studies, approval of new products and indications and the receipt of reimbursement coverage. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Securities Act and the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control, including those risks and uncertainties discussed under “Risk Factors” in our 10-K filing dated February 28, 2018 and subsequent quarterly filings with the SEC. All information in this presentation is as of the date of this presentation, and we undertake no duty to update this information unless required by law.

Intersect ENT Opportunity LARGE MARKET $3B+ TAM in US for Chronic Sinusitis GROWTH DRIVERS Expanded Salesforce PRODUCT PIPELINE Enrolling ASCENDTM RCT for Drug-Coated Sinus Balloon FINANCIAL STRENGTH GM 79% (Q318) Cash Balance $104M (Q318**) REVENUE ($M) * Preliminary estimate based on currently available information. Has not been audited or reviewed by our independent registered public accounting firm and is subject to quarter-end closing adjustments, and actual results may differ. ** Cash Balance is balance of cash, cash equivalents and investments. UNIQUE PRODUCTS Four PMA/NDA Approved Drug Releasing Implants $108.3 - 108.5M

Dedicated to Transforming ENT Care 1 in 8 Adults Top 10 Most Costly Condition for US Employers 25 work days lost per year per patient Focus on Chronic Sinusitis Providing innovative, clinically meaningful therapies

PROPEL & SINUVA: Innovative & Clinically Proven 1ST DRUG RELEASING IMPLANTS FOR CHRONIC SINUSITIS Local Delivery, Mechanical Spacing, Bioabsorbable Improving Surgical Outcomes Managing Recurrent Disease FAMILY

OFFICE HOSPITAL / ASC Portfolio Extending Across Chronic Sinusitis Indications and Care Settings Frontal Maxillary Ethmoid

Large Patient Population and Market * Company estimates. ~2M Patients, $3B TAM Early Stage (Office) Advanced (Surgery) Continuing (Office) PATIENTS 800,000 540,000 635,000 TAM $1.1B $0.8B $1.3B Addressing CS Across the Continuum of Care

Commitment to Evidence-Based Innovation 14 Prospective Clinical Studies 40 Centers in US > 900 Patients Pilot (PROPEL) 43 Patients 4 Sites ADVANCE 50 Patients 7 Sites ADVANCE II 105 Patients 11 Sites PROGRESS (mini) 80 Patients 11 Sites PROGRESS (Contour) 80 Patients 12 Sites EXCEED (Contour) 15 Patients 2 Sites RESOLVE pk 5 Patients 1 Site RESOLVE pilot 12 Patients 4 Sites RESOLVE 100 Patients 18 Sites RESOLVE II 300 Patients 40 Sites 3 PROPEL In-Office Studies 80 Patients 2 Sites ENCORE 50 Patients 12 Sites FAMILY

FAMILY Improving Surgical Outcomes

PROPEL Family 3 Surgical Products to Improve Outcomes Advanced into Surgically Enlarged Sinus Cavity OPENS Self-Expanding Implant Conforms to and Holds Open Sinus DELIVERS Sustained, Targeted Delivery of Steroid Over 30 Days MAINTAINS Opening by Reducing Post-Operative Inflammation and Scarring MULTIPLE SINUSES

Approved for Placement in Ethmoid Sinus Only Device Used in Sinus Surgery Backed by Level 1a Evidence 35% Reduction in Post-Operative Intervention PROPEL and PROPEL Mini Clinically Proven Outcomes Meta-analysis: Han JK, Marple BF, Smith TL et al. Int Forum Allergy Rhinol, Vol. 2, No. 4, July/August 2012 ETHMOID SINUS POST-OPERATIVE INTERVENTION p=0.0008 35% INFLAMMATION (POLYPOSIS) p<0.0001 46% NEED FOR ORAL STEROIDS p=0.0023 40% SCARRING (ADHESIONS) p=0.0013 70% META-ANALYSIS 200+ Patient Prospective, Randomized, Blinded, Multi-Center Trials

p=0.1094 FRONTAL AND MAXILLARY SINUSES p=0.0023 P<0.0001 p=0.0078 PROPEL Contour Clinically Proven Outcomes CONTOUR STUDY 80 Patient Prospective, Randomized, Blinded, Multi-Center Trial Post-operative Intervention* Oral Steroid Intervention** Occlusion/ Restenosis** 65% 35% 63% Surgical Intervention** 73% Luong A, et al., JAMA Otolaryngology–Head & Neck Surgery, Published online November 2, 2017. *Judged by an independent reviewer. ** Judged by clinical investigators. The p-values for the secondary endpoints adjusted for multiplicity. BENEFITS Designed for Patients in Surgical or Office Setting of Care Enhances Physician Choice: Smaller Size, Unique Hourglass Shape, Flexible Applicator

GROWTH DRIVERS Leverage expanded salesforce (~140 reps) Continue PROPEL Contour Roll-out Add New Accounts Expand Physician Usage PROPEL FAMILY Continuing Commercial Traction 1 in 8 Sinus Surgeries ~ 50% of Accounts TODAY 1 in 3 ENTs ~ 280,000 Patients Treated As of Q4, 2018

Focus on Higher Quality of Care with Lower Overall Cost COST EFFECTIVENESS STUDY1 Placement of PROPEL following FESS “is a cost-effective intervention for preventing a postoperative intervention within 60 days after surgery.” BUDGET IMPACT MODEL2 Use of PROPEL is “expected to save the plan money” Revision Surgery Polypectomy Surgical Adhesion Lysis Repair of Turbinate Lateralization Drugs 1 Rudmik L and Smith TL. Economic Evaluation of a Steroid-Eluting Sinus Implant following Endoscopic Sinus Surgery for Chronic Rhinosinusitis. Otolaryngol Head Neck Surg. 2014 May 5;151(2):359-366. 2 Rudmik L, Mallow P, Swetha, P and Rizzo, J. Budget Impact Analysis of Bioabsorbable Drug Eluting Sinus Implants for Endoscopic Sinus Surgery; International Society of Pharmocoeconomics Outcomes and Research, 2015. PROPEL Family Strong Value Proposition REIMBURSEMENT IN PLACE Covered through Hospital Facility Fee Reimbursement

Designed to Deliver

Designed for Patients Who Have Had Prior Surgery Dilates Obstructed Cavity Delivers~4x Steroid (vs. PROPEL) Over 90 Days 100% Patient Compliance OVERVIEW ETHMOID SINUS SINUVA Office Treatment for Recurrent CRS/Polyps Ethmoid Sinus Pre-implant Immediately Post-implant 6 Weeks Post-implant

NDA Approved December 2017 4 Studies Conducted in over 400 patients Targeted Commercial Launch Q218 SINUVA Clinically Proven Outcomes ETHMOID SINUS 300 Patient Prospective, Randomized, Blinded, Multi-Center Trial CO-PRIMARY and KEY SECONDARY ENDPOINTS MET Reduction in Bilateral Polyp Grade (p=0.0073) Improvement in Nasal Obstruction/Congestion (p=0.0074) Reduction in Proportion of Patients Indicated for Repeat FESS, Reduction in Ethmoid Obstruction, Improvement in Sense of Smell Outcomes 74% Relative Reduction in Polyp Grade 30% Relative Reduction in Nasal Obstruction /Congestion 61% Reduction in Indication for Revision Surgery at Day 90 RESOLVE II Study Data on file, Intersect ENT.  RESOLVE II CR-00014 Rev. 1.0 January 2018

SINUVA Reduction in Polyps and Sinus Obstruction ENDOSCOPIC OUTCOMES * p-value < 0.0001 BILATERAL POLYP GRADE ETHMOID SINUS OBSTRUCTION Treatment Control Change from Baseline 0% -5% -10% -15% -20% -25% -30% Data on file, Intersect ENT.  RESOLVE II CR-00014 Rev. 1.0 January 2018. Grading by Clinical Investigators.

SINUVA Reimbursement Basics *Ernst FR, Imhoff RJ, DeConde, Manes RP. Steroid-Eluting Sinus Implant Versus Revision Surgery for Patients with Recurrent Chronic Rhinosinusitis with Nasal Polyps (CRSwNP): An Economic model. Poster presentation at 2018 International Society of Pharmacoeconomics and Outcomes Research (ISPOR) meeting. Coding Healthcare Economics Cost Savings Budget Impact Model Indicates 23-35% Cost Savings with Use of SINUVA* PRODUCT CODE Submissions Via Unassigned J Code (J3490) Seeking Product Specific J Code PROCEDURE CODE(S) Procedure Reimbursement via Existing CPT Procedure Codes, per Physician Work Performed

SINUVA Foundation Established in 2018 Positive Clinical Experience ~1200 Patients Treated ~500 Physicians Top 6 Commercial Payors Providing Access Established Network of SPs & SDs Prior-Authorizations in <30 Days Increasing Use of Buy and Bill ~25% Salesforce Growth in ‘18 Expanded Reimbursement Team RX PAYOR COVERAGE PHYSICIAN & PATIENT PRODUCT ACCESS FIELD FORCE

ASCEND Drug Coated Balloon Emerging Pipeline Product Conducting Clinical Study of Investigational ASCEND Mometasone Furoate Drug Coated Balloon (DCB) Designed to Improve Peripheral Sinus Patency Regulatory Path: PMA MARKET OPPORTUNITY Focus primarily on office setting of care Expands product offering to meet needs of patients with early stage disease (800k patients, $1.1B TAM) DESIGNED FOR PERIPHERAL SINUSES ASCEND STUDY 70 Patient Prospective, Randomized, Blinded, Multi-Center Trial Commenced Dec. 2018, Top-line results by end 2019 The ASCEND Drug Coated Balloon is investigational and not currently available for sale in the United States. The product is limited by federal (or United States) law to investigational use only.

Emerging Opportunity Outside the US ~540K FESS / Year ~450K FESS / Year ~250K FESS / Year OUS TO CONTRIBUTE TO LONG-TERM GROWTH Establishing Germany as European beachhead Expanding to Switzerland, Austria and England Pursuing Japan Shonin Regulatory Approval

REVENUE ($M) 2019 Outlook COMMERCIAL Leverage 2018 Salesforce Expansion Ramp SINUVA REIMBURSE-MENT Streamline Product Access Secure Product Specific J Code to Support SINUVA Long-term * Preliminary estimate based on currently available information. Has not been audited or reviewed by our independent registered public accounting firm and is subject to quarter-end closing adjustments, and actual results may differ. CLINICAL STUDIES ENCORE Results Q219 (Safety of SINUVA Repeat Use) ASCEND DCB Top-Line Results by Year-End $123M - $127M

NASDAQ: XENT