Download intersect ent, inc. form 8-k

INTERSECT ENT, INC.
FORM
8-K
(Current report filing)
Filed 05/11/15 for the Period Ending 05/11/15
Address
Telephone
CIK
Symbol
SIC Code
Fiscal Year
1555 ADAMS DRIVE
MENLO PARK, CA 94025
650-641-2100
0001271214
XENT
3841 - Surgical and Medical Instruments and Apparatus
12/31
http://www.edgar-online.com
© Copyright 2015, EDGAR Online, Inc. All Rights Reserved.
Distribution and use of this document restricted under EDGAR Online, Inc. Terms of Use.
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): May 11, 2015
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))
Item 7.01
Regulation FD Disclosure
On May 11, 2015, Intersect ENT, Inc. made available its updated Corporate Presentation. A copy of the Corporate Presentation is attached as Exhibit 99.1.
The information in this Item 7.01 and Exhibit 99.1 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 this Item 7.01 and Exhibit 99.1 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
(d)
Financial Statements and Exhibits.
Exhibits
Exhibit
No.
Description
99.1
Corporate Presentation dated May 2015.
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: May 11, 2015
By:
/s/ Jeryl L. Hilleman
Jeryl L. Hilleman
Chief Financial Officer
INDEX TO EXHIBITS
Exhibit
No.
Description
99.1
Corporate Presentation dated May 2015.
Exhibit 99.1
Company Presentation
MAY 2015
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.
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 Form 10-K filing dated March 11,
2015 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.
1
ADVANCING CLINICALLY-PROVEN THERAPIES
for Ear, Nose and Throat (ENT)
Physicians and Patients
Focus on Chronic Sinusitis (CS)
29M
Patients in US
IMPROVING QUALITY OF LIFE
from Surgery to Office Care
2
Chronic Sinusitis: Significant Unmet Need
DEBILITATING INFLAMMATORY CONDITION
1 in 8 Adults
3.5M Managed by ENT
500,000+ Surgeries / Year
Top 10
Most Costly Condition for US Employers
3
1st Two Commercial Products
st
1 Drug Releasing Implants for Chronic Sinusitis Patients
Only PMA Approval
for CS Patients
IMPROVING
SURGICAL OUTCOMES
60,000+ Patients
to Date
Reduced Inflammation, Scarring and Need
for Additional Surgery and Oral Steroids
4
Intersect ENT Opportunity
ANNUAL REVENUE ($M)
LARGE
MARKET
$4.8B TAM in US
$39
UNIQUE
PRODUCTS
st
1 and Only Drug Releasing
Implants in ENT
$18
PRODUCT
PIPELINE
In-Office Products to Serve
Continuum of Care
TRACK
RECORD
Strong Revenue Growth
and Gross Margins (70+%)
$6
2012
2013
2014
5
CS Treatment Pathway
MEDICATION
TO TREAT
SURGERY
TO OPEN (FESS)
MANAGEMENT
TO MAINTAIN
Oral Steroids Reduce
Inflammation but Can
Cause Side Effects
Surgery Opens Pathways but
Can Result in Post-Operative
Scarring and Inflammation
Within One Year, 64%
Symptom Recurrence and
10% Revision Surgery
Challenges Across the Continuum of Care
6
Our Solution Portfolio
MEDICATION
TO TREAT
SURGERY
TO OPEN
MANAGEMENT
TO MAINTAIN
Stenting & Local Drug Delivery via
Bioabsorbable Implant Technology
NOVA
PROPEL
RESOLVE
Office Treatment for
Primary CS Patients
Treatment to Improve
Surgical Outcomes
Office Treatment for
Recurrent CS Patients
NOVA and RESOLVE are investigational and not currently available for sale in the United States.
The implants are limited by federal (or United States) law to investigational use only.
7
PROPEL / PROPEL MINI
How It Works
ETHMOID SINUS
Advanced into
Surgically Enlarged
Sinus Cavity
OPENS
DELIVERS
MAINTAINS
Self-expanding Implant
Conforms to and
Holds Open Sinus
Sustained, Targeted
Delivery of Steroid
Over 30 Days
Opening by Reducing
Post-operative
Inflammation and Scarring
8
PROPEL
Clinically Proven Surgical Outcomes
Reduction in Post-Operative
Medical and Surgical Interventions
Meta-Analysis of Two Prospective, Multicenter,
Randomized, Controlled, Double-Blind Studies
•
3 Prospective Trials, 200+ Patients
•
Only Device Used in Sinus Surgery
Backed by Level 1a Evidence
POST-OPERATIVE
INTERVENTION
INFLAMMATION
(POLYPOSIS)
NEED FOR
ORAL STEROIDS
SCARRING
(ADHESIONS)
35%
46%
40%
70%
p=0.0008
p<0.0001
p=0.0023
p=0.0013
Meta-analysis: Han JK, Marple BF, Smith TL et al. Int Forum Allergy Rhinol, Vol. 2, No. 4, July/August 2012
9
PROPEL
Commercial Success
REVENUE ($M)
78%
$13.4
$7.0
$8.5
$7.5
$13.4
Q1’15 vs.
Q1’14
$9.1
PENETRATION*
$4.2
1 in 4 Accounts
Q313
Q413
Q114
Q214
SALESFORCE
•
•
•
•
US Only
66 Territory Managers
10,000 ENTs
7,500 Perform FESS
Q314
Q414
Q115
REIMBURSEMENT
• FESS ~$14K
• Propel Treated as
Surgical Supply
• ASP $728
1 in 5 Sinus Surgeons
1 in 15 Patients
Early in
Adoption Cycle
* Intersect ENT internal estimates through Q115
10
PROPEL
Strong Base to Drive Forward Revenue
CONSISTENT ANNUALIZED
SALES/TERRITORY MGR ($000)
$1,200
70
$1,000
60
$800
50
GROWING BASE OF
RECURRING REVENUE ($M)
$16
$14
$12
40
$600
$-
$6
20
$4
10
$2
0
$0
Q1/14 Q2/14 Q3/14 Q4/14 Q1/15
Ending # of TMs
Annualized Sales/TM
85%
$8
30
$400
$200
$10
Q1/14
New
Q2/14
Q3/14
Q4/14
Q1/15
Reorder
11
PROPEL MINI
Expanding Indications
Seeking Expanded Indication for
Placement in Frontal Sinus
FRONTAL SINUS
25% of Sinus Surgeries
INVESTIGATIONAL
PROGRESS
Currently Enrolling Prospective, Randomized,
Blinded, Multi-Center Trial
80 Patients | 14 Sites
GOAL
Demonstrate Reduction in Need for Post-Operative Interventions
Such as Additional Surgery and Oral Steroids
PROPEL mini for frontal indication is an investigational device. Limited by Federal (or United States) law to investigational use
12
Our Solution Portfolio: In-Office Therapies
MEDICATION
TO TREAT
SURGERY
TO OPEN
MANAGEMENT
TO MAINTAIN
NOVA
PROPEL
RESOLVE
Office Treatment for
Primary CS Patients
Treatment to Improve
Surgical Outcomes
Office Treatment for
Recurrent CS Patients
NOVA and RESOLVE are investigational and not currently available for sale in the United States.
The implants are limited by federal (or United States) law to investigational use only.
13
RESOLVE
How It Works
IN-OFFICE POST PRIOR SURGICAL TREATMENT
Designed:
ETHMOID SINUS
• For Patients with Refractory CS/Polyps
• To Dilate Obstructed Cavity
• To Deliver Steroid Over 90 Days
• Less Invasive, More Cost Effective vs. Revision Surgery
Ethmoid Sinus
Pre-implant
Immediately
Post-implant
6 Weeks
Post-implant
Investigational Drug Only. Not approved for sale in U.S.
14
RESOLVE
Promising Results
Reduction in Polyp Burden and
Patient Symptoms
THREE TRIALS COMPLETE
•
Pilot (12)
Prospective, Multicenter, Randomized, Controlled,
Blinded 100 Patient Study
•
PK Study (5)
•
RESOLVE (100)
CHANGE IN OBSTRUCTION/
CONGESTION SCORE
CHANGE IN
BILATERAL POLYP GRADE
0
-0.2
Treatment
Control
-0.4
-0.6
-0.8
-1
p<0.05
All pts (n=100)
> Grade 2 polyps (n=74)
p = ns
p<0.05
0.0
-0.2
-0.4
-0.6
-0.8
-1.0
-1.2
-1.4
Change from Baseline in Endoscopic and Symptom Scores vs. Sham Procedure.
Format modified from Han JK, Forwith KD, Smith TL, et al. RESOLVE: a randomized, controlled, blinded study of bioabsorbabl e steroid
releasing sinus implants for in-office treatment of recurrent sinonasal polyposis. Int Forum Allergy Rhinol. 2014;4:861-870.
15
RESOLVE
IND Clinical Program
STUDY
DESCRIPTION
N
SITES
PILOT
Non-Randomized
Open Label
Single Cohort
12
4
PHARMACOKINETIC
(PK)
Non-Randomized
Open Label
Single Cohort
5
1
100
18
300
45
RESOLVE
Phase II / III
Randomized 1:1
Blinded
PUBLISHED
Implants vs. Sham Procedure
RESOLVE II
Phase III
Randomized 2:1
Blinded
Implants vs. Sham Procedure
16
NOVA
How It Works
IN-OFFICE or SURGICAL SOLUTION
FRONTAL AND
MAXILLARY SINUSES
•
•
•
•
Primary (Including Post Dilation) or Revision Patients
Hourglass Shape to Maximize Tissue Apposition and Support
Regulatory Pathway: PMA-S
Feasibility Study Completed (15 Patients, 2 US Sites)
Frontal Placement
Maxillary Placement
Investigational Device Only. Not approved for sale in U.S.
17
Large U.S. Market Opportunity
SURGICAL
$830M
NOVA
PRIMARY
2.3M Patients
$2.8B
PROPEL
540K Patients
$4.8B
in US
$1.1B
RESOLVE
REFRACTORY
770K Patients
18
Emerging Opportunity Outside the US
~250K FESS / Year
~450K FESS / Year
~540K FESS / Year
ATTRACTIVE MARKET OPPORTUNITIES
Targeting 4-6 Large Markets in Europe and
Asia Pacific
PROPEL has CE Mark Approval
DEVELOPING MARKET
COMMERCIALIZATION PLANS
Regulatory Pathways (Especially China, Japan)
Reimbursement Activities
KOL Development
Market Entry Strategy
19
Industry Landscape
MEDICATION
TO TREAT
STEROIDS
SURGERY
TO OPEN
MANAGEMENT
TO MAINTAIN
SURGICAL TOOLS / SUPPLIES
We Are a Unique Solution – Complementary to Other Technologies
20
Multiple Barriers to Entry
CLINICAL
REGULATORY
•
Level 1a Evidence
•
Only Drug Releasing Implants in ENT
•
Award Winning Clinical Science
•
Two PMA Approvals
•
15 Peer-Reviewed Publications
•
RESOLVE: NDA Pathway
INTELLECTUAL PROPERTY
R&D / MANUFACTURING
2
•
55 Issued Patents (29 US / 26 OUS)
•
50,000 ft Facility in Menlo Park, CA
•
37 Pending Patents (13 US / 24 OUS)
•
•
Covers Sinus Delivery of
Drug Releasing Implants
Specialized Capabilities in
Bioabsorbable DES
•
Robust Quality System
21
Outlook: Milestones
GROWTH
LEVERS
Commercial
PROPEL
Clinical
International
RESOLVE
Clinical
NOVA
Clinical
2015
2016
2017
2018
Ongoing Execution
PROGRESS
Frontal Indication
Enrollment Complete
Frontal Indication
PROPEL mini
PMA-S Approval
Lay OUS Groundwork
RESOLVE II
Enrollment
Commenced
RESOLVE II
Enrollment
Complete
Clinical Trials
PMA-S
Approval
frontal
NDA
Approval
PMA-S
Approval
maxillary
22
Experienced Leadership
MANAGEMENT TEAM
LISA EARNHARDT
JERI HILLEMAN
President & CEO
CFO
CHAS McKHANN
RICH KAUFMAN
Chief Commercial Officer
COO, SVP R&D & Operations
ROB BINNEY
JAMES STAMBAUGH
VP Sales
VP Clinical Affairs
SUSAN STIMSON
AMY WOLBECK
VP Marketing
VP Regulatory Affairs & Quality
EXPERIENCE INCLUDES
23
$4.8B US Market
1st and ONLY Drug Releasing Implants in ENT
EMERGING In - Office Portfolio
TRACK RECORD Strong Revenue Growth & GMs
24
NASDAQ: XENT