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): November 27, 2017
____________________________________________________________________________________________
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 2.02 Results of Operations and Financial Condition.
On November 27, 2017, OptiNose, Inc. (the “Company”) issued a press release announcing its financial results for its third quarter ended September 30, 2017. A copy of the press release is attached as Exhibit 99.1 to this report and is incorporated herein by reference.
The information included in this Item 2.02, including Exhibit 99.1, is being "furnished" pursuant to Item 2.02 and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any Company filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act (regardless of any general incorporation language in such filing) unless expressly incorporated into such filing by specific reference to the "furnished" information contained herein.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. | Description | |
99.1 | Press Release dated November 27, 2017, announcing financial results for the third quarter ended September 30, 2017 | |
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: November 27, 2017
EXHIBIT INDEX
Optinose Reports Third Quarter 2017 Financial Results and Recent
Operating Highlights
FDA Approval of XHANCE™, Successful IPO, Leadership Team Expanded
to Drive Commercialization
YARDLEY, PA, November 27, 2017— Optinose (NASDAQ:OPTN), a pharmaceutical company focused on
patients treated by ear, nose and throat (ENT) and allergy specialists, today reported financial results for
the quarter ended September 30, 2017, and provided recent operational highlights.
“Following our successful initial public offering in October, we are well-positioned to launch XHANCE in
the second quarter of 2018,” said Optinose chief executive officer Peter Miller. “With an outstanding
leadership team in place, we expect an exciting and productive year ahead as we work to deliver
XHANCE to patients in need. We believe XHANCE has the potential to improve the lives of millions of
patients who are searching for new treatment options and lays a strong foundation for Optinose to
become a leading ENT/allergy company.”
Third Quarter 2017 and Recent Highlights
FDA Approval of XHANCE: The U.S. Food & Drug Administration approved the Company’s New Drug
Application for XHANCE (fluticasone propionate) nasal spray, 93mcg (previously referred to by the
development name OPN-375) for the treatment of nasal polyps in patients 18 years of age and older, as
announced on September 18, 2017. XHANCE is designed to deliver medicine to targeted areas high and
deep in the nose using one of Optinose’s patented Exhalation Delivery Systems (EDS) for the up to 10
million Americans who suffer from nasal polyps and the symptoms that accompany them.
Successful IPO: Optinose completed its initial public offering (IPO) of 8,625,000 shares of common stock
at a public offering price of $16.00 per share, which included an additional 1,125,000 shares of common
stock issued upon the exercise in full by the underwriters of their option to purchase additional shares,
on October 17, 2017. The aggregate gross proceeds to Optinose from the offering were approximately
$138 million before deducting underwriting discounts and commissions and estimated offering expenses
payable by Optinose. All of the shares were offered and sold by Optinose.
Leadership Team Expanded to Drive XHANCE Commercialization: On October 30, 2017, Optinose
announced the addition of five new members to the leadership team to drive the commercialization of
XHANCE:
Ricci Whitlow, Vice President, Technical Operations. With over 20 years of manufacturing, supply
chain and product development related experience, Ms. Whitlow will drive all activities associated
with the commercial supply chain; clinical supplies; chemistry, manufacturing and controls; and
device development of the product portfolio. She was most recently responsible for the
management of nine pharmaceutical manufacturing sites as part of Catalent, a large contract
pharmaceutical manufacturer, and has extensive prior technical operations experience at companies
including Johnson & Johnson and LifeCell.
Harry Sacks, MD, Vice President, Medical Affairs and Corporate Medical Officer. Bringing more
than 20 years of experience in pharmaceutical clinical development and medical affairs and deep
expertise in the respiratory therapeutic category, Dr. Sacks was recently Vice President and Head of
Respiratory, U.S. Clinical Development and Medical Affairs at Novartis. Dr. Sacks also held leadership
roles in medical and scientific affairs and clinical development with a strong focus on respiratory at
companies including Forest Research Institute, Meda Pharmaceuticals and Schering-Plough
Corporation.
John Peterkins, Vice President, Market Access. Mr. Peterkins assumes leadership of all components
of market access including pricing strategy, contracting, patient access and health plan coverage. He
has more than 20 years of relevant experience in the pharmaceutical industry, having recently
established a market access team for the launch of the branded business unit and helping lead Sun
Pharmaceuticals through three launches in two years. Prior to Sun, Mr. Peterkins spent more than
18 years at Johnson & Johnson in various leadership roles in the pharma/biologics business including
leading the managed markets team for Immunology, Oncology and Virology for the Janssen Biotech
and Janssen Therapeutics businesses.
David Fabbri, Vice President, Sales. A seasoned business leader with more than 20 years of
pharmaceutical commercial experience in sales, marketing and commercial operations roles, Mr.
Fabbri is responsible for building, training and leading a performance-driven sales team and
supporting sale force infrastructure at Optinose. Mr. Fabbri’s prior commercial experience includes
leadership roles at Johnson & Johnson and at Sun Pharmaceuticals where he led numerous
marketing and field sales teams and executed multiple product launches.
Andrew Muzsi Vice President, Marketing. Mr. Muzsi will lead the development and implementation
of marketing strategy. Mr. Muzsi brings 20 years of broad marketing experience to Optinose
including U.S. marketing, global marketing and payer marketing. Mr. Muzsi has prior experience at
Johnson & Johnson and Bayer and most recently worked at Bristol-Myers Squibb where he held
several marketing roles within the U.S. and global organizations including key leadership positions
launching market-leading products including Eliquis.
Launched Clinical Nurse Educator Team calling on approximately 10,000 ENT and Allergy Specialists:
Within six weeks of FDA approval of XHANCE, Optinose recruited, trained and deployed approximately
85 Clinical Nurse Educators (CNEs) targeting approximately 10,000 ENT and allergy specialists. The
objectives of the CNE team are to introduce Optinose as a company, raise awareness of the significant
unmet need that exists within nasal polyps, explain how the Optinose EDS enables delivery of
medication to targeted areas deep in the nose and familiarize healthcare practitioners with proper use
of XHANCE. The CNE team initiated customer engagement activities on November 13, 2017.
Third Quarter 2017 Financial Results
Research and development expenses for the three-month period ended September 30, 2017, were $6.6
million. General and administrative expenses totaled $6.6 million for the three-month period ending
September 30, 2017. Net loss for the period was $13.1 million, or $4.23 per share (basic and diluted,
after giving effect to the 1-for-2.8879 stock split that occurred on October 10, 2017). As of September
30, 2017, Optinose had cash and cash equivalents of $49.4 million. In addition, the Company raised
$125.5 million in net cash proceeds from the closing of its IPO on October 17, 2017. Following the
closing of the IPO, the Company had 37,761,273 shares of common stock outstanding.
About Optinose®
Optinose is a specialty pharmaceutical company on a mission to improve lives with a focus on patients
cared for by ear, nose and throat (ENT) and allergy specialists. The Company’s first two products rely on
its patented Exhalation Delivery Systems (EDS), which are capable of deep intranasal deposition of
medication. The exhalation delivery systems enable the creation of products with potential for
meaningful new clinical benefits. Optinose developed its first product, Onzetra® Xsail® (sumatriptan nasal
powder), through the completion of Phase 3 and subsequently out-licensed the product to Otsuka
Pharmaceutical Co., Ltd. Onzetra Xsail received FDA approval and was launched in the U.S. in 2016. The
Company’s second product, XHANCE (fluticasone propionate) nasal spray, is approved for the treatment
of nasal polyps in patients 18 years of age and older and is in development for the treatment of chronic
sinusitis. Subsequent Optinose pipeline products will aim to serve the needs of patients treated by ENT
and allergy specialists and are expected to include products using EDS as well as other technologies. The
Company is also currently engaged in the early development of products for neurologic orphan diseases
for which the “nose-to-brain” application of an EDS may enable improved treatment. This includes OPN-
300 (autism and others) and OPN-21 (narcolepsy and others). Optinose has corporate offices in the U.S.,
the U.K. and Norway. To learn more, please visit www.optinose.com.
Cautionary Note on Forward-Looking Statements
This press release contains “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
planned launch of XHANCE in the second quarter of 2018; development plans and potential advantages
of XHANCE 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 supply chain and commercial infrastructure and capabilities to launch XHANCE; physician
and patient acceptance of XHANCE; our ability to obtain adequate third-party reimbursement for
XHANCE; varying interpretation of clinical data; and the risks, uncertainties and other factors discussed
in the “Risk Factors” section and elsewhere in our filings with the Securities and Exchange Commission -
which are available at 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 press release speak only as of
the date of this press release, and we undertake no obligation to update such forward-looking
statements, whether as a result of new information, future developments or otherwise.
Optinose Media Contact
Kate Traynor, Sloane & Company
Ktraynor@sloanepr.com
212.446.1871
2017 2016 2017 2016
Licensing revenues -$ -$ -$ 47,500$
Operating expenses:
Research and development 6,641 3,868 15,620 12,241
Selling, general and administrative 6,553 1,761 13,214 5,057
Total operating expenses 13,194 5,629 28,834 17,298
(Loss) income from operations (13,194) (5,629) (28,834) 30,202
Other (income) expense, net (126) 477 517 2,001
Net (loss) income (13,068)$ (6,106)$ (29,351)$ 28,201$
Deemed dividend 4,105 2,752 11,255 8,254
Accretion to redemption value 19 527 1,093 1,582
Net (loss) income attributable to common stockholders (17,192)$ (9,385)$ (41,699)$ 18,365$
Net (loss) income per share of common stock
basic (4.23)$ (2.32)$ (10.25)$ 0.77$
diluted (4.23)$ (2.32)$ (10.25)$ 0.63$
Weighted average common shares outstanding
basic 4,067,717 4,050,065 4,067,717 4,049,800
diluted 4,067,717 4,050,065 4,067,717 4,975,012
Three Months Ended
September 30,
Nine Months Ended
September 30,
OptiNose, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
(Unaudited)
September 30, December 31,
2017 2016
(unaudited)
Cash and cash equivalents 49,410$ 36,797$
Other assets 5,725 4,754
Total assets 55,135$ 41,551$
Total other liabilities 9,699$ 9,319$
Convertible notes payable, net - 15,256
Redeemable convertible preferred stock 236,542 168,173
Total stockholders' deficit (191,106) (151,197)
Total liabilities and stockholders' deficit 55,135$ 41,551$
OptiNose, Inc.
Condensed Consolidated Balance Sheet Data
(in thousands)