OPTINOSE, INC. IPO Filings,Withdrawn,Pricings, Calendar, Market Details-2017

Company Description-We are a specialty pharmaceutical company focused on the development and commercialization of products for patients treated by ear, nose, and throat, or ENT, and allergy specialists. Our lead product, XHANCE (fluticasone propionate) nasal spray, utilizes our proprietary Breath Powered exhalation delivery system, or EDS, to deliver a topically-acting and potent anti-inflammatory
corticosteroid for the treatment of chronic rhinosinusitis with nasal polyps and, if approved, chronic rhinosinusitis without nasal polyps. Chronic rhinosinusitis is a serious nasal inflammatory disease that is currently treated using therapies, such as intranasal steroids, or INS, that have significant limitations.
We believe XHANCE has a differentiated clinical profile with the potential to become part of the standard of care for this disease because it is able to deliver medication to the primary site of inflammation high and deep in the nasal passages in regions not adequately reached by current INS. We also believe that payors will respond favorably to XHANCE’s clinical, cost and quality-of-care profile, as compared to current and potential future costly drug therapy and surgical treatment options.We were incorporated in Delaware in May 2010. Our predecessor entity OptiNose AS was formed under the laws of Norway in September 2000. In 2010, OptiNose AS became our subsidiary as part of an internal reorganization.Our primary executive offices are located at 1020 Stony Hill Road, Suite 300,
Yardley, Pennsylvania 19067 and our telephone number are (267) 364-3500. Our
website address is www.optinose.com.

Proposed Symbols: OPTN

Market: NASDAQ Global

CIK: 0001494650

Address: 1020 STONY HILL ROAD

City, State, Zip: YARDLEY, PA 19067

Telephone: 267-364-3500

CEO: Peter K. Miller

Employee Count: 39

Fiscal Year: 12/31

URL: www.optinose.com

 

Deal Data
Status: Filed

Share Price: 15.00-17.00

Shares Offered: 6,250,000

Offer Amount:

Total Expenses: $2,800,000.00

Shares Over Alloted: 937,500

Shareholder Shares Offered:

Shares Outstanding: 35,386,273

Lockup Period / Expiration:

Quiet Period Expiration:

 

Financials
Revenue: $0.00

Net Income: ($16,283,000.00)

Total Assets: $63,962,000.00

Total Liabilities: $6,225,000.00

Stockholders’ Equity: ($174,681,000.00)
 Advisors

Lead Underwriter(s): 
BMO Capital Markets Corp
Jefferies LLC
Piper Jaffray & Co.
RBC Capital Markets, LLC

Underwriter(s) :

Company Counsel :
Hogan Lovells US LLP
Underwriter Counsel :
Cooley LLP
Auditor :
Ernst & Young LLP
Transfer Agent :
Broadridge Corporate Issuer Solutions, Inc

Description of Business-

On September 18, 2017, the U.S. Food and Drug Administration, or FDA, approved
our new drug application, or NDA, for XHANCE for the treatment of nasal polyps
in patients 18 years of age or older. We expect to launch XHANCE for the
treatment of nasal polyps in the second quarter of 2018 with a dedicated sales
force targeting a specialty prescriber base comprised of approximately 15,000
physicians in the United States. We expect our sales force will initially
consist of approximately 75 representatives. We plan to initiate additional
clinical trials of XHANCE in the second half of 2018 to seek a follow-on
indication for the treatment of chronic sinusitis to broaden our market
opportunity.

We have conducted five clinical trials evaluating over 1,500 adult patients,
including two randomized, double-blinded, placebo-controlled Phase 3 pivotal
clinical trials in adults with nasal polyps and two supportive open-label
Phase 3 clinical trials in adults with symptoms of chronic sinusitis with and
without nasal polyps. In both Phase 3 pivotal clinical trials, patients treated
with XHANCE experienced statistically significant reductions of both nasal
congestion/obstruction symptoms and total polyp grade, which was the co-primary
endpoints. Treatment benefits were also observed in all four defining symptoms
of chronic rhinosinusitis, as well as in polyp elimination, quality of life,
need for sinus surgery and patient global impression of change. In addition, the
magnitude of improvement for patients treated by XHANCE in our Phase 3 pivotal
clinical trials, as measured by the Sinonasal Outcome Test-22, a validated
clinical outcome assessment was comparable to the reported benefits in
third-party studies of endoscopic sinus surgery, or ESS, and balloon sinus
dilation. In addition, XHANCE had an adverse event profile generally comparable
to the profile reported in similarly designed studies with conventional INS. In
our supportive open-label Phase 3 clinical trials, which evaluated approximately
900 patients with symptoms of chronic sinusitis with and without nasal polyps
for a period of up to one year, XHANCE was generally well tolerated and produced
results on efficacy endpoints similar to those observed in our Phase 3 pivotal
clinical trials. In these supportive trials, we observed comparable symptom
improvements in patients with and without nasal polyps and continuing
incremental polyp reduction and symptom improvement through 12 months.

We intend to efficiently launch XHANCE into the ENT and allergy market segments.
Initially, we will focus our marketing efforts on moderate-to-severely
symptomatic patients who have not achieved satisfactory results with currently
available INS. We plan to educate physicians, payors, and patients on XHANCE’s
unique mechanism of action and differentiated efficacy profile. We also intend
to establish a meaningful value proposition for these key stakeholders by
highlighting the potential for XHANCE to reduce or delay the need for surgical
intervention, reduce antibiotic prescribing and increase patient satisfaction
with treatment outcomes. We are also engaging payors to secure broad market
access for XHANCE in the commercial segment by targeting Tier 3 payor coverage,
single step edit with no prior authorization. This level of coverage indicates
that payors would require patients to use a generic INS as a first step in
treating their disease prior to the payor covering XHANCE. However, such
coverage would not require the prior authorization of the payor. Tier 3 payor
coverage requires a patient co-pay that is higher than that required for
generics or drugs within a payor’s formulary.

Use of Proceeds-We estimate that we will receive net proceeds of $90.2 million, or $104.2
million if the underwriters exercise their option to purchase additional shares in full, from the sale of the shares of common stock offered by us in this  offering, based on an assumed initial public offering price of $16.00 per share, which is the midpoint of the price range set forth on the cover page of this
prospectus, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.A $1.00 increase (decrease) in the assumed initial public offering price of
$16.00 per share would increase (decrease) the net proceeds to us from this offering by $5.8 million, assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions.Similarly, a 1.0 million share increase (decrease) in the number of shares offered by us, as set forth on the cover page of this prospectus, would increase (decrease) the net proceeds to us by $14.9 million, based on an assumed initial public offering price of $16.00 per share, which is the midpoint of the price range set forth on the cover page of this prospectus, after deducting the estimated underwriting discounts and commissions.

We currently estimate that we will use the net proceeds of this offering as
follows:

. approximately $55.0 million to support the planned launch of XHANCE, including
investments in marketing and sales, inventory and our commercial
infrastructure;

. approximately $20.0 million to fund further development efforts for XHANCE,
including the initiation of FDA-mandated pediatric studies, clinical trials
necessary to seek approval for a follow-on indication of XHANCE for the
treatment of chronic sinusitis and medical affairs activities; and

. the remainder to fund other working capital and general corporate purposes,
including expenses to build corporate infrastructure to support us becoming a
the publicly-traded commercial company, including associated regulatory and
quality activities.

The expected use of the net proceeds from this offering represents our
intentions based upon our current plans and business conditions, which could
change in the future as our plans and business conditions evolve. The amounts
and timing of our actual expenditures depend on numerous factors, including the
success of our commercialization efforts, the progress of our clinical
development efforts for XHANCE for a follow-on indication for the treatment of
chronic sinusitis and the progress of our preclinical and clinical development
efforts with respect to our other product candidates. As a result, our
management will have broad discretion in applying the net proceeds from this
offering. An investor will not have the opportunity to evaluate the economic,
financial or other information on which we base our decisions on how to use them
net proceeds.

Although we may use a portion of the net proceeds from this offering for the
acquisition or licensing, as the case may be, of products, product candidates,
technologies, compounds, other assets or complementary businesses, we have no
current understandings, agreements or commitments to do so. Pending these uses,
we plan to invest the net proceeds from this offering in short- and
intermediate-term, interest-bearing obligations, investment-grade instruments,
certificates of deposit or direct or guaranteed obligations of the U.S.
government.

Although it is difficult to predict future liquidity requirements, we believe
that the net proceeds from this offering, together with our existing cash
resources will be sufficient to enable us to fund our operations into the first
the quarter of 2019, including to support the planned launch of XHANCE. With respect
to the additional research and development efforts for XHANCE, including the
initiation of FDA-mandated pediatric studies and the clinical trials necessary
to seek approval for a follow-on indication for the treatment of chronic
sinusitis, we expect that we will require additional funds as these studies and
trials progress, the exact amounts of which will depend on the timing, design
and outcome of the clinical trials and our cash position. We have based these
estimates on assumptions that may prove to be incorrect, and we could use our
available capital resources sooner than we currently expect. We may need to
raise additional capital through public offerings and private placements of our
equity securities, debt financings, strategic partnerships, alliances and
licensing arrangements, or a combination thereof.

Competition / Competitors-

Our industry is highly competitive and subject to rapid and significant
technological change as research provides a deeper understanding of the
pathology of diseases and new technologies and treatments are developed. We
believe our scientific knowledge, technology, and development capabilities
provide us with substantial competitive advantages, but we face potential
competition from multiple sources, including large pharmaceutical,
biotechnology, specialty pharmaceutical and, to a lesser degree, medical device
companies.

XHANCE will compete primarily with INS, oral steroids and other medical
management products, including locally compounded liquid budesonide in
high-volume nasal rinses. XHANCE will also compete with surgical procedures,
balloon sinus dilation products and steroid-releasing sinus implants. Key
competitive factors affecting the commercial success of XHANCE and any other
product candidates we may develop are likely to be efficacy, safety and
tolerability profile, reliability, the convenience of administration, price and
reimbursement.

The only other branded INS on the market indicated for the treatment of nasal
polyps is Nasonex, which is marketed by Merck & Co., Inc. A generic version of
Nasonex, mometasone furoate monohydrate, was approved by the FDA for, among
other indications, the treatment of nasal polyps and launched in 2016. In
addition, Beconase AQ, which is an INS marketed by GlaxoSmithKline, is indicated
for the prophylaxis of nasal polyps after surgical resection. There are no
products approved for the treatment of chronic sinusitis without nasal polyps.
There are two categories of INS: first-generation INS products, which include
Rhinocort, Nasacort AQ and Qnasl; and second-generation INS products, which
include Flonase, Veramyst, Omnaris, and Zetonna. The primary difference between
first- and second-generation INS products is that first-generation INS are
absorbed into the blood to a greater extent than second-generation INS, with
systemic bioavailability ranging from 10% to 50% compared to a systemic
bioavailability with fluticasone propionate, a second-generation INS, of less
than 2%. Many of the most widely-prescribed INS products are available in
generic form and some, such as Flonase (fluticasone propionate), are available
over-the-counter.

Several companies are also currently developing biologic monoclonal antibodies
for the treatment of nasal polyps. These biologic monoclonal antibodies, which
inhibit specific pathways of inflammation present in nasal polyps, include
omalizumab, reslizumab, mepolizumab, and dupilumab. Omalizumab has been studied
in investigator-initiated Phase 2 clinical trials. GlaxoSmithKline has studied
mepolizumab in a sponsor-initiated Phase 2 clinical trial and plans to begin
enrolling patients in Phase 3 clinical trial later this year with study
completion anticipated in 2019. Dupilumab has been studied in a
sponsor-initiated Phase 2 clinical trial and Sanofi is currently investigating
it in two Phase 3 clinical trials that are enrolling patients and expected to be
completed in the second half of 2018. If these biologic monoclonal antibodies
are successfully developed and approved for marketing, they could represent
significant competition for XHANCE.

Leave a Reply

Your email address will not be published. Required fields are marked *