Optinose, Inc. (OPTN) 10-K Annual Report March 2019

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 year ended December 31, 2018, and provided recent operational highlights.

“We made great progress in 2018 building a business that can support long-term success,” stated CEO Peter Miller. “Our focus on defining the appropriate target patient type for XHANCE, highlighting the strong data supporting the efficacy of XHANCE, and ensuring physician understanding and appreciation of our patient affordability program has bolstered physician perception of XHANCE. As a result of these efforts, I am happy to report that we accelerated XHANCE growth in the fourth quarter of 2018 and have continued to see strong growth in early 2019. The year ahead is an important one for Optinose and the launch of XHANCE. I am confident that we have the right team and plan to build a company that can serve the needs of ENT and allergy specialist physicians, and the patients they treat."

Fourth Quarter and Recent Highlights

Commercial Update

From third quarter to fourth quarter 2018 XHANCE^® (fluticasone propionate) prescriptions increased by 50 percent. In addition, XHANCE prescriptions increased 38 percent from December 2018 to January 2019, and increased 39 percent from the four-week period ended January 25^th to the four-week period ended February 22^nd, which is the most recent four-week period available.

Based on currently available third-party data and our internal analyses, the Company estimates that more than 75 percent of commercially insured lives are in a plan in which XHANCE is covered in a Tier 3 formulary position.

In April 2019, the Company plans to expand its sales force by 20 Territory Managers to call on an incremental 1,800 "XHANCE naive" physicians. The Company also intends to internalize its contract sales force in April 2019.

XHANCE Development Update

In addition to XHANCE’s existing indication for nasal polyps, the Company plans to seek approval for a follow-on indication for the treatment of chronic sinusitis in the U.S. in order to broaden its market opportunity. In December 2018, the Company initiated the first of two anticipated Phase 3b clinical trials.

Additional U.S. Patents Covering XHANCE

The United States Patent and Trademark Office (USPTO) recently issued four patents covering XHANCE. These patents, U.S. Patents 10,076,614, 10,076,615, 10,124,132, and 10,179,216, have been listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) for XHANCE and have terms that expire in years 2034, 2029, 2027, and 2033, respectively. XHANCE is now covered by 13 Orange Book-listed patents.

The full text of each patent is available on the USPTO website www.uspto.gov.

The following information was filed by Optinose, Inc. (OPTN) on Wednesday, March 6, 2019 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Material Contracts, Statements, Certifications & more

Optinose, Inc. provided additional information to their SEC Filing as exhibits

Exhibit 10.1: Material Contract

Exhibit 10.20: Material Contract

Exhibit 21.1: Subsidaries Of The Registrant

Exhibit 23.1: Consents Of Experts And Counsel

Exhibit 31.1: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 31.2: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 32.1: Section 1350 Certification

Exhibit 32.2: Section 1350 Certification

Ticker: OPTN
CIK: 1494650
Form Type: 10-K Annual Report
Accession Number: 0001494650-19-000020
Submitted to the SEC: Wed Mar 06 2019 7:14:59 AM EST
Accepted by the SEC: Wed Mar 06 2019
Period: Monday, December 31, 2018
Industry: Pharmaceutical Preparations