Optinose, Inc. (OPTN) SEC Filing 10-K Annual report for the fiscal year ending Monday, December 31, 2018

Optinose, Inc.

CIK: 1494650 Ticker: OPTN
Exhibit 99.1


Optinose Reports Fourth Quarter and Full Year 2018 Financial Results
and Recent Operational Highlights

Company reports fourth quarter and full year 2018 net XHANCE revenue of $3.0 million and $7.1 million

XHANCE prescriptions increased 50 percent from Q3 to Q4 of 2018

Conference call and webcast to be held today at 8:00 a.m. Eastern Time

YARDLEY, Pa., March 6, 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 25th to the four-week period ended February 22nd, 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

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

Document And Entity Information Document
Consolidated Balance Sheets
Consolidated Balance Sheets (Parenthetical)
Consolidated Statements Of Cash Flows
Consolidated Statements Of Changes In Redeemable Convertible Preferred Stock And Stockholders'
Consolidated Statements Of Changes In Redeemable Convertible Preferred Stock And Stockholders' (Parenthetical)
Consolidated Statements Of Comprehensive Income And Loss
Consolidated Statements Of Operations
Accrued Expenses
Accrued Expenses (Details)
Accrued Expenses (Tables)
Avp-825 License Agreement
Avp-825 License Agreement (Details)
Commitments And Contingencies
Commitments And Contingencies (Future Minimum Lease Payments) (Details)
Commitments And Contingencies (Leases) (Details)
Commitments And Contingencies (Purchase Commitments) (Details)
Commitments And Contingencies (Tables)
Convertible Notes
Convertible Notes - Narrative (Details)
Employee Benefit Plans
Employee Benefit Plans (Details)
Income Taxes
Income Taxes (Tables)
Income Taxes - Narrative (Details)
Income Taxes - Schedule Of Deferred Tax Assets And Liabilities (Details)
Income Taxes - Schedule Of Effective Income Tax Rate Reconciliation (Details)
Income Taxes - Schedule Of Income Before Income Tax, Domestic And Foreign (Details)
Inventory (Details)
Inventory (Tables)
Liquidity (Details)
Long-Term Debt
Long-Term Debt (Tables)
Long-Term Debt - Narrative (Details)
Long-Term Debt - Schedule Of Long Term Debt (Details)
Organization And Description Of Business
Property And Equipment
Property And Equipment (Details)
Property And Equipment (Tables)
Related-Party Transactions
Related-Party Transactions (Details)
Stock-Based Compensation
Stock-Based Compensation (Tables)
Stock-Based Compensation - Black-Scholes Pricing Model Options (Details)
Stock-Based Compensation - Employee Stock Purchase Plan (Details)
Stock-Based Compensation - Narrative (Details)
Stock-Based Compensation - Service-Based Stock Options (Details)
Stock-Based Compensation - Stock-Based Compensation Expense (Details)
Stockholders' Equity
Stockholders' Equity (Details)
Stockholders' Equity - Common Stock (Details)
Stockholders' Equity - Warrants (Details)
Subsequent Events
Subsequent Events (Details)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (Details)
Summary Of Significant Accounting Policies (Policies)
Summary Of Significant Accounting Policies (Tables)
Summary Of Significant Accounting Policies - Antidilutive Shares Excluded From Earnings Per Share (Details)
Summary Of Significant Accounting Policies - Concentration Risk (Details)
Summary Of Significant Accounting Policies - Property And Equipment (Details)
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

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