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): April 9, 2018
____________________________________________________________________________________________
OPTINOSE, INC.
(Exact Name of Registrant as Specified in its Charter)
____________________________________________________________________________________________
DELAWARE | 001-38241 | 42-1771610 |
(State or Other Jurisdiction of Incorporation or Organization) | (Commission File No.) | (I.R.S. Employer Identification No.) |
1020 Stony Hill Road, Suite 300
Yardley, Pennsylvania 19067
(Address of principal executive offices and zip code)
(267) 364-3500
(Registrant’s telephone number, including area code)
(Former name or former address, if changed from 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 (see General Instruction A.2. below):
q | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
q | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
q | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
q | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-14(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). | |
ý | Emerging growth company |
ý | 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 7.01 Regulation FD Disclosure.
Corporate Presentation
On April 9, 2018, OptiNose, Inc. posted an updated Corporate Presentation on its website www.optinose.com. A copy of the presentation is furnished hereto as Exhibit 99.1 and is incorporated by reference herein.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. | Description | |
99.1 | ||
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.
OptiNose, Inc. | ||
By: /s/ Keith A. Goldan | ||
Keith A. Goldan | ||
Chief Financial Officer | ||
Date: April 9, 2018
Building a Leading ENT / Allergy
Specialty Company
Corporate Presentat ion
A p r i l 9 , 2 0 1 8
2
Forward Looking Statements
This presentation and our accompanying remarks contain “forward-looking statements” within the meaning
of the U.S. Private Securities Litigation Reform Act of 1995. All statements that are not historical facts are
hereby identified as forward-looking statements for this purpose and include, among others, statements
relating to: the initiation and timing of clinical trials for chronic sinusitis; brand awareness and market access
objectives; market opportunities; commercial strategies; potential advantages of XHANCETM and our product
candidates; and other statements regarding our future operations, financial performance, prospects,
intentions, objectives and other future events.
Forward-looking statements are based upon management’s current expectations and assumptions and are
subject to a number of risks, uncertainties and other factors that could cause actual results and events to
differ materially and adversely from those indicated by such forward-looking statements including, among
others: our ability to establish commercial and other capabilities to successfully launch XHANCE; physician
and patient acceptance of XHANCE; our ability to obtain adequate third-party reimbursement for XHANCE
(market access); uncertainties and delays relating to the initiation, completion and results of clinical trials;
market opportunities for XHANCE may be smaller than we believe; and the risks, uncertainties and other
factors discussed in the “Risk Factors” section and elsewhere in our most recent Form 10-K and Form 10-Q
filings with the Securities and Exchange Commission – which are available at http://www.sec.gov.
As a result, you are cautioned not to place undue reliance on any forward-looking statements. Any forward-
looking statements made in this presentation speak only as of the date of this presentation, and we
undertake no obligation to update such forward-looking statements, whether as a result of new information,
future developments or otherwise.
3
Emerging Growth Company with Approved Products
BUILDING A LEADING ENT / ALLERGY SPECIALTY COMPANY
• 3.5 Million CRS patients (1.2M with nasal polyps) being treated by 15,000 physicians
• Limited competition anticipated from any pharma companies at launch
XHANCE Represents a Significant Opportunity in Attractive ENT/Allergy Market
• Potential to be first product approved for chronic sinusitis indication—trials planned for 4Q 2018
• Expected to support expansion into primary care treating an additional 6.25M patients
“Pipeline Within a Product” Creates Substantial Near-Term Value
• Product candidates identified that could be developed using EDS platform for ENT/allergy market
• External pipeline products also identified for potential partnering or acquisition in ENT/allergy
Additional Pipeline Focused on Products for ENT/Allergy to Leverage Infrastructure/Expertise
• Several candidates (Narcolepsy, Prader-Willi) are aimed at innovative “nose-to-brain” delivery approach
• Plan to develop through proof of concept and to seek partnerships for further growth
Create Additional Value by Early Development of Additional EDS Platform Products
4
Our Research on Over 300 Products Suggests
Successful Launches are Driven by Four Key Factors
Market Access
Attractive Market…with High Unmet Need
Differentiated Product
Awareness / Execution
5
Mild Moderate
Severe
• Highly prevalent in the
United States (~65M)
• Largely OTC / generic
market
• Well-treated using INS
Allergic
Rhinitis
* Based on US Adult Population Survey (n=10,336).
• ~30M US adults suffer from
CRS—up to 10M with Nasal
Polyps
• 9.75M patients actively seeking
physician care annually
• 7M patients have had surgery
(frequently non-curative)
• Only one other FDA-approved
branded product “for the
treatment of nasal polyps” and
no FDA-approved product for
chronic sinusitis
Chronic
Rhinosinusitis
(CRS)
Allergic
Rhinitis
65M
Perennial
Rhinitis
18M
Chronic
Rhinosinusitis
w/o NP
20M
w/ NP
10M
Large CRS Population with Severe Symptoms
6
A diagnosis characterized by chronic
inflammation
• Disease persists for many years
• Significant quality of life impact (comparable to CHF,
COPD, Angina)
• Symptoms Include: congestion and blocked nose,
purulent drainage, facial pain/pressure, loss of sense of
smell, chronic sleep problems, headaches, fatigue,
halitosis, mood disorders
Persistent inflammation causes swelling, pain
and obstruction in a high and deep region of
the nasal passages where sinuses open
Flares are common and require treatment with
antibiotics and other medications
CRS (with or without Polyps)
THE ROOT ISSUE IS INFLAMMATION (NOT INFECTION)
7
High Cost, Typically Not Curative
Sinus Surgery
Up to 80% of patients may continue to have
symptoms post-surgery
Continued INS
use after surgery is typical
$8,500–$16,000 per procedure, and repeat
surgery is not uncommon
Limited Efficacy
Medical Management
Saline nasal sprays, irrigation, neti pot, nebulizers,
conventional intranasal steroids (INS)
80% of patients are frustrated with
lack of symptom relief with INS
75% of physicians believe INS nasal sprays do not
work well because they don’t sufficiently
reach site of inflammation
Existing Treatments Are Often Sub-Optimal
LIMITED EFFICACY, HIGH COST, DIFFICULT, PAINFUL, MEDICAL RISKS, FREQUENTLY NOT CURATIVE
Source: Palmer J et al . A cross-sectional population-based survey of the prevalence, disease burden, and characteristics of the US adult population with symptoms of chronic
rhinosinusitis (CRS). Poster session presented at: 62nd Annual Meeting of the American Rhinologic Society; September 16-17, 2016; San Diego, CA
Optinose Market Research. Data on file.
8
Problem:
Nasal sprays and aerosols do not effectively place drug
high and deep in the nasal passages
Solution:
Unique new concept for delivery gets medicine to
targeted sites of inflammation
Drug
released
into
airflow
Pressure
balances
Soft palate
closes
Blow into
device
Press bottle up to open device valve
and actuate
• Mouthpiece and sealing nosepiece
• Utilizes natural functional behaviors of the upper airway
Naturally exhaled breath seals the soft palate
• Drug released into the exhaled breath is deposited high and
deep in the nasal passages
• Exhaled air routed through proprietary exhalation delivery
system (EDS)
• “Positive pressure” delivery expands narrow passages
Helps the drug flow around anatomical obstructions to broadly fill one
side of the nasal cavity
• Simple, quick use with limited coordination requirements
A Breakthrough Approach to Nasal Delivery
SOLVES A KNOWN MEDICAL PROBLEM IN A UNIQUE NEW WAY
9
Optinose EDS w/Exhalation
Nasal Spray w/o Exhalation
Intranasal steroids are TOPICALLY ACTING medications:
Delivery to sites of chronic inflammation and
nasal polyp origin is important
Sinus drainage
regions are key
treatment targets
Optinose EDS Can Deliver Drug High & Deep in the Nose
KEY TO TREATING CRS (W OR W/OUT POLYPS)
10
Trial Type N Sites
NAVIGATE I
Phase 3
Pivotal
323 54
NAVIGATE II
Phase 3
Pivotal
323 38
EXHANCE-3
Phase 3
open-label
3 month
700 38
EXHANCE-12
Phase 3
open-label
12 month
223 21
Study 1102
Phase 1
bioavailability
112 2
Global Clinical Program*
Improvement on all four defining
symptoms of CRS
Reduction in the need for surgery
Magnitude of relief comparable to surgery
“Medical” polyp elimination in some patients
A substantially higher percentage of patients reported
being “much” or “very much” improved versus placebo
Key Highlights
Differentiated Clinical Profile
1,500+ Patients
792 w/o polyps
780 w/ polyps
* In Navigate I & II, 91% of patients reported previous use of a nasal steroid for the treatment of nasal polyps, and 54% reported previous sinus surgery or polypectomy
Similar improvements in patients with and without
nasal polyps
11
WAVE 1
Enter High-Density
ENT/Allergy Specialty Market
• 14,000 Physician Targets
• 80 Sales Reps Ramping up to 120
• Additional 1,000 physicians targeted
through digital and non-personal
promotion
• Limited Competition
• Promotion of Nasal Polyp Indication
~3.5M Patients
(1.2M with Nasal Polyps)
WAVE 2
Facilitate Broader Adoption
in Primary Care
• Future Chronic Sinusitis indication
facilitates broadening target market
• Additional 50,000 Primary Care
Targets
• May pursue co-promote partner
~6.25M Patients
WAVE 3
Activate Patient Demand
• Significant Direct to Patient
Opportunity
• Access “Lapsed Users” who are still
suffering
• Symptomatic nature allows patients
to self-identify for evaluation
~20M Patients
Retail
Launch
Commenced
in Early April
2018
Commercialization Strategy - Build XHANCE into a Leading Product
12
96.1%
0
5
10
15
20
25
30
35
40
45
Database
Population
% of Population
with no CRS Claim
% of Population
with CRS Claim
P
at
ie
n
t Cla
im
s Da
ta
b
as
e
41M
3.9%
30 Million U.S. Adults Suffer from Chronic Rhinosinusitis
~9.75M PATIENTS CURRENTLY UNDER ACTIVE CARE OF A PHYSICIAN FOR CRS
Approximately 3.9% of patients in claims database
have a code for CRS (2010–2012) ~9.75M CRS Patients being treated in physician offices
US Adult Population
Prevalence of
CRS Claims
ICD9 Code: 471.x and
473.x
250 Million
3.9%
9.75M
CRS Patient being Treated in
Physician Office
Patients Treated
CRS Unique Patient Claims
13
* BID dosing required for the treatment of nasal polyps, based upon Nasonex data and academic literature. WAC prices reflect a 2x multiple on the WAC price for conventional INS due
to the approved dose for the treatment of nasal polyps.
^ Nasonex and Mometasone are currently the only other intranasal steroids approved for the treatment of nasal polyps.
Pricing Landscape Offers Attractive Scenarios
FOR NASAL POLYPS
$0
$500
$1,000
$10,000
$20,000
$30,000
$40,000
Mometasone*^
(Per Month)
Fluticasone*
(Per Month)
Nasonex*^
(Per Month)
Qnasal*
(Per Month)
Dymista*
(Per Month)
Endoscopic Sinus
Surgery
(Per procedure)
Monoclonal
Antibodies
(Per Year)
$8,500 to
$16,000
$35,000
$475
CONVENTIONAL INTRANASAL STEROIDS
$425
XHANCE
(Per Month)
SURGERY / BIOLOGICS
$39 $380$357$209
TR
EA
TM
EN
T
C
O
ST
XHANCE priced at
~10% Discount to
Branded Nasonex
GENERIC
BRANDED
14
PREVALENCE
OVERALL TREATED PATIENTS
TREATED PATIENTS
IN SEGMENT
TOTAL ANNUAL US MARKET
OPPORTUNITY
SEGMENT ANNUAL MARKET
OPPORTUNITY
INCREMENTAL PCP OPPORTUNITY
(1) Target market represents ~10,000 ENT and allergy specialists and ~5,000 high-decile INS prescribing primary care physicians.
(2) Based on our internal estimates.
SPECIALTY MARKET OPPORTUNITY
~3.5 Million
CRS patients currently treated in ENT /
Allergy specialty offices annually
~6.25 Million
CRS patients currently treated by primary
care physicians annually
KEY DRIVER
$3.4B Market Opportunity Within Specialty
TOTAL MARKET OPPORTUNITY OF >$9.5B (Nasal Polyps + CS Indications)
30 Million Chronic Rhinosinusitis Sufferers in US
(7 Million Have Had Surgery)
9.75 Million
CRS patients currently in physician
offices being treated annually
ENT & Allergy Specialty Segment(1)
>$3.4B(2)
Primary Care Segment
>$6.0B(2)
Total Specialty and Primary Care
>$9.5B(2)
15
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
Allergists ENTs PCPs
Li
ke
lih
o
o
d
t
o
P
re
scri
b
e
N=200 N=202 N=302
Percent of HCPs stating they will definitely or probably prescribe a product profile similar to XHANCE
Differentiated Physician Reaction to Profile
SUGGESTS HIGH LAUNCH INTEREST AND ‘STANDARD OF CARE’ POTENTIAL
Majority of Physician Interest in
Prescribing Is Reported After Presenting a Product
Profile with Only a NP Indication
Physician Stated Interest
Product profile with
NP and CS Indications
Product profile with
NP Indication
“ ”…There is a real need in the medical community to be able to deliver intranasal steroids higher and deeper in the nasal
cavity…
Allergist / Immunologist
“ ”…If the Optinose Device is approved, I will definitely use it in my practice; no question….
Otolaryngologist
“ ”… The Optinose Device will be a game changer… and will really improve our ability to care for patients….
Director, Division of Rhinology
Source: Optinose Market Research (2015). Data on file.
16
Introducing XHANCETM
Retail
Launch
Commenced
in Early April
17
Awareness,
Trial and
Adoption
Market
Access
Brand
Differentiation
Commercial
Capabilities
LAUNCH EXECUTION PRIORITIES
18
Commercial
Capabilities
Hired an experienced first-line
sales leadership team
Recruited & trained fully-dedicated contract
territory managers (TMs)
Experienced Sales Team Optimally Deployed to
Accelerate Adoption of XHANCE at Launch
~8,000 HCPs targeted at launch
Growing to ~14,000 based on expansion of market access
(additional 1,000 physicians targeted through digital and non-personal promotion)
~80 TMs deployed on March 5th
Growing to ~120 based on expansion of market access
19
Awareness,
Trial and
Adoption
Social media: reached 10,000 ENTs and
allergists and delivered 700,000 impressions
Multi-Channel Integrated Marketing Program Increased Aided
Awareness to Over 73% in the Past 4 Months
Initial reaction from target physicians
to core brand messages is positive
Launched Xhance Xperience
program in early March
Clinical Nurse Educators: reached ~5,000
ENT/allergy physicians and delivered over
10,000 presentations
20
XHANCE Xperience Program - Initiated in Market on 3/5
▪ Limited availability program offering select physicians
and their patients an opportunity to gain initial
experience with XHANCE
▪ Enrolled patients receive up to two prescription fills of
XHANCE at no cost to them ($0 co-pay)
▪ A full-service pharmacy coordinates fulfillment
As of March 31st, more than 530 unique physicians have written
a total of 1,200+ prescriptions
XPERIENCE
21
Market Access on Track to Support Retail Launch
Market
Access
Engaged with 40 payers representing
85% of commercial lives
Objective is to achieve 75% tier 3 market
access for commercial lives by YE 2018
Covered Commercial
Lives at Launch
Favorable health system economics
(e.g., surgical cost savings) suggest potential to
more than offset drug acquisition cost
Expect > 65% tier 3 market access for
commercial lives during retail launch
22
Market Access
Current Patients Dissatisfied with Existing Treatment
Physician Dissatisfaction with Current Treatments
Attractive Market…with High Unmet Need
Differentiated Product
Physician Stated Interest to Prescribe
Covered Commercial Lives at Launch
Awareness / Execution
Awareness During Launch
AssessmentIndicator/Objective
>80% of patients frustrated with lack of symptom
relief with their current INS
>80%
Aided awareness within 8,000 target ENT and
allergists during launch
85%
65%
T3 Coverage at
Launch
70%–80%
75%
On
Target
On
Target
Market Dynamics, Product Characteristics and Execution to Date
Provide a Strong Foundation for a Successful Launch
>75% of physicians agree, in part, that INS medications do not
work because they do not reach the site of inflammation
Physicians’ stated interest to prescribe based on
product profile similar to XHANCE
23
Chronic Sinusitis Follow-on Indication (sNDA)
Plan to submit
protocol to FDA
in 1H 2018
Selection of CRO
and study
locations
First patients
expected to
enroll in 4Q 2018
Phase 3b trial design expected to include co-primary
endpoints: both an objective measure of inflammation and a
subjective measure of symptom relief
24
Achieve greater than 85% aided awareness of XHANCE in target ENT and allergist
audience during retail launch
Secure market access for XHANCE ≥65% of patients with commercial insurance
plans at retail launch expanding to 75% by year end
Successfully launch XHANCE in April 2018
Initiate clinical studies with XHANCE in fourth quarter 2018 to support future
Chronic Sinusitis indication
Focus on executing our business strategy given our strong balance sheet
2018 Stands to be an Important Year
Key
Objectives
For 2018
25
Investor Relations – NASDAQ: OPTN
Analyst Coverage1
BMO: Gary Nachman
Jefferies: David Steinberg
Piper Jaffray: David Amsellem
RBC: Randall Stanicky
Optinose Investor Contact
Jonathan Neely, VP, Investor Relations
and Business Operations
267-521-0531
1 - Optinose is followed by the analysts listed above. Please note that any opinions, estimates or forecasts regarding the Company’s performance made by
these analysts are theirs alone and do not represent opinions, forecasts or predictions of Optinose or its management. Optinose does not by its reference
above or distribution imply its endorsement of or concurrence with such information, conclusions or recommendations.
investors@optinose.com
www.optinose.com
At 31 December 2017:
– $234.5 million in cash
– 37.9 million common share o/s
– Long-term debt, net: $71.9 million
@optinose
Building a Leading ENT / Allergy
Specialty Company
Corporate Presentat ion
A p r i l 9 , 2 0 1 8