OptiNose(OPTN) - 2020 Q3 - Quarterly Report

Note Regarding Forward-Looking Statements This section outlines forward-looking statements in Form 10-Q, based on current expectations, subject to risks, and not subject to future updates - Forward-looking statements cover various aspects including the impact of COVID-19, XHANCE product development and commercialization, OPN-019 development, future revenue growth, operating expenses, and capital requirements[9] - Statements are subject to numerous risks and uncertainties that could cause actual results to differ materially, as discussed in this Form 10-Q and the annual report on Form 10-K under 'Risk Factors'[11] - The company disclaims any obligation to update forward-looking statements, even if new information becomes available, advising readers to consult future SEC filings[12] Market, Industry and Other Data This section cautions that the report's market data, estimates, and projections are inherently uncertain and may differ from actual results - The Form 10-Q includes estimates, projections, market research, and other data from independent third parties, third parties on the company's behalf, and the company itself, concerning markets for XHANCE, market access, and prescription data[16] - Information based on estimates, projections, or similar methodologies is inherently uncertain, and actual results, events, or circumstances may differ materially[16] Part I — Financial Information Item 1. Financial Statements This section presents the unaudited interim consolidated financial statements and detailed notes explaining the company's financial position and performance Consolidated Balance Sheets The Consolidated Balance Sheets present the company's financial position, detailing assets, liabilities, and stockholders' equity as of specific dates | Metric | September 30, 2020 (in thousands) | December 31, 2019 (in thousands) | | :-------------------------- | :-------------------------------- | :-------------------------------- | | Total Assets | $181,024 | $172,650 | | Total Liabilities | $153,341 | $111,067 | | Total Stockholders' Equity | $27,683 | $61,583 | | Cash and cash equivalents | $143,134 | $147,144 | | Long-term debt, net | $105,013 | $74,531 | Consolidated Statements of Operations The Consolidated Statements of Operations detail revenues, costs, and net loss for the reported periods, highlighting performance changes | Metric | 3 Months Ended Sep 30, 2020 (in thousands) | 3 Months Ended Sep 30, 2019 (in thousands) | 9 Months Ended Sep 30, 2020 (in thousands) | 9 Months Ended Sep 30, 2019 (in thousands) | | :-------------------------------- | :--------------------------------------- | :--------------------------------------- | :--------------------------------------- | :--------------------------------------- | | Net product revenues | $15,436 | $8,667 | $32,770 | $19,320 | | Licensing revenues | $0 | $3,730 | $0 | $4,230 | | Total revenues | $15,436 | $12,397 | $32,770 | $23,550 | | Total operating expenses | $33,320 | $32,206 | $99,538 | $96,230 | | Loss from operations | $(17,884) | $(19,809) | $(66,768) | $(72,680) | | Net loss | $(21,214) | $(28,808) | $(75,922) | $(85,058) | | Net loss per share (basic & diluted) | $(0.43) | $(0.69) | $(1.62) | $(2.06) | Consolidated Statements of Comprehensive Loss The Consolidated Statements of Comprehensive Loss present net loss and other comprehensive loss components, primarily foreign currency translation adjustments | Metric | 3 Months Ended Sep 30, 2020 (in thousands) | 3 Months Ended Sep 30, 2019 (in thousands) | 9 Months Ended Sep 30, 2020 (in thousands) | 9 Months Ended Sep 30, 2019 (in thousands) | | :-------------------------------- | :--------------------------------------- | :--------------------------------------- | :--------------------------------------- | :--------------------------------------- | | Net loss | $(21,214) | $(28,808) | $(75,922) | $(85,058) | | Foreign currency translation adjustment | $13 | $(12) | $(17) | $(22) | | Comprehensive loss | $(21,201) | $(28,820) | $(75,939) | $(85,080) | Consolidated Statements of Changes in Stockholders' Equity This statement details changes in stockholders' equity, reflecting impacts from stock compensation, net loss, and common stock issuances | Metric | December 31, 2019 (in thousands) | September 30, 2020 (in thousands) | | :-------------------------- | :------------------------------- | :------------------------------- | | Total Stockholders' Equity | $61,583 | $27,683 | | Stock compensation expense (9M 2020) | N/A | $7,857 | | Net loss (9M 2020) | N/A | $(75,922) | | Sale of common stock, net of offering costs (9M 2020) | N/A | $33,405 | Consolidated Statements of Cash Flows The Consolidated Statements of Cash Flows summarize cash generated from or used in operating, investing, and financing activities, showing net cash changes | Metric | 9 Months Ended Sep 30, 2020 (in thousands) | 9 Months Ended Sep 30, 2019 (in thousands) | | :-------------------------------- | :--------------------------------------- | :--------------------------------------- | | Net cash used in operating activities | $(67,049) | $(72,709) | | Net cash used in investing activities | $(460) | $(485) | | Net cash provided by (used in) financing activities | $63,502 | $(2,302) | | Net decrease in cash, cash equivalents and restricted cash | $(4,018) | $(75,507) | | Cash, cash equivalents and restricted cash at end of period | $143,147 | $125,504 | Notes to Unaudited Interim Consolidated Financial Statements These notes provide detailed explanations and disclosures for the unaudited interim consolidated financial statements, covering key financial aspects 1. Organization and Description of Business This note describes OptiNose, Inc. as a specialty pharmaceutical company focused on ENT and allergy, with XHANCE as its primary commercial product - OptiNose, Inc. is a specialty pharmaceutical company focused on developing and commercializing products for patients treated by ear, nose and throat (ENT) and allergy specialists[31] - XHANCE (fluticasone propionate) nasal spray, 93 mcg, is the company's first commercial product, approved by the FDA in September 2017 for the treatment of nasal polyps[31] - The company has two ongoing Phase 3b clinical trials evaluating XHANCE as a treatment for chronic sinusitis[31] 2. Liquidity This note discusses the company's cash position, future capital needs, and ability to draw additional funds, emphasizing ongoing financing requirements - As of September 30, 2020, the company had cash and cash equivalents of $143.1 million[32] - The company expects to draw an additional $20 million from the Third Delayed Draw Notes by early 2021, having exceeded the XHANCE net sales and royalties threshold for Q3 2020[33] - Additional capital will likely be required in the future through equity or debt financings, partnerships, collaborations, or other sources to meet debt service obligations and fund planned development and commercial activities[34] 3. Basis of Presentation and Summary of Significant Accounting Policies This note outlines the basis of financial statement preparation, use of estimates, and key accounting policies for revenue recognition and credit risk - The unaudited interim consolidated financial statements have been prepared in conformity with US generally accepted accounting principles (GAAP)[36] - Management makes estimates and assumptions that affect the reported amounts of assets and liabilities, and actual results may materially vary from these estimates[40] - Revenue from XHANCE sales is recognized when customers obtain control of the product, with the transaction price including estimates of variable consideration such as provider chargebacks, trade discounts, product returns, government rebates, payor rebates, and patient assistance programs[46][47][50] 4. Inventory This note breaks down inventory components (raw materials, WIP, finished goods), valued at the lower of cost or net realizable value | Inventory Component | September 30, 2020 (in thousands) | December 31, 2019 (in thousands) | | :------------------ | :-------------------------------- | :-------------------------------- | | Raw materials | $2,733 | $1,227 | | Work-in-process | $2,137 | $676 | | Finished goods | $4,456 | $1,581 | | Total inventory | $9,326 | $3,484 | - Inventories are stated at the lower of cost or net realizable value, determined on a first-in, first-out basis[63] 5. Property and Equipment This note details the company's property and equipment, net of accumulated depreciation, and reports the depreciation expense incurred for the reported periods | Asset Category | September 30, 2020 (in thousands) | December 31, 2019 (in thousands) | | :-------------------------- | :-------------------------------- | :-------------------------------- | | Computer equipment and software | $1,113 | $1,112 | | Furniture and fixtures | $366 | $366 | | Machinery and equipment | $3,139 | $3,142 | | Leasehold improvements | $609 | $609 | | Construction in process | $474 | $70 | | Less: accumulated depreciation | $(3,293) | $(2,247) | | Total Property and equipment, net | $2,408 | $3,052 | - Depreciation expense was $473 thousand for the three months ended September 30, 2020 (vs. $286 thousand in 2019) and $1.0 million for the nine months ended September 30, 2020 (vs. $877 thousand in 2019)[64] 6. Leases This note describes the company's lease agreements for office space, storage, and equipment, presenting recognized operating lease assets and liabilities | Lease Metric | September 30, 2020 (in thousands) | | :-------------------------- | :-------------------------------- | | Non-current operating lease assets | $5,999 | | Current operating lease liabilities | $1,904 | | Non-current operating lease liabilities | $4,236 | | Total operating lease liabilities | $6,140 | - On September 18, 2020, the company amended an existing office lease agreement to extend the term by three years[65] 7. Accrued Expenses and Other Current Liabilities This note details accrued expenses and other current liabilities, including product revenue allowances, SG&A, R&D, and payroll expenses | Liability Category | September 30, 2020 (in thousands) | December 31, 2019 (in thousands) | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Product revenue allowances | $15,540 | $12,858 | | Selling, general and administrative expenses | $5,349 | $5,544 | | Research and development expenses | $4,363 | $3,379 | | Payroll expenses | $6,686 | $7,810 | | Total accrued expenses and other current liabilities | $37,281 | $32,514 | 8. Licensing Revenue This note details licensing agreements, outlining payments and royalties, noting no licensing revenue recognized in the reported periods - Under the Inexia License Agreement, the company received a $0.5 million upfront payment in Q1 2019 and is eligible for up to $8 million in development milestone payments and $37 million in sales milestone payments, plus tiered royalties[71] - Under the Currax License Agreement, the company received a $3.7 million upfront payment in Q3 2019 and is eligible for an additional $0.8 million in escrow, a one-time 10% royalty on Onzetra net sales over $3 million for 2020, and a $1 million regulatory milestone[73] - No licensing revenues were recognized by the company during the three and nine months ended September 30, 2020[73] 9. Long-term Debt This note describes the Pharmakon Senior Secured Notes, detailing terms, payment schedule, and covenants, with the company in compliance - The Pharmakon Senior Secured Notes provide up to $150 million in debt financing, with $80 million issued on September 12, 2019, and an additional $30 million (First Delayed Draw Notes) on February 13, 2020[74] - The company has the option to issue an additional $20 million (Third Delayed Draw Notes) by February 15, 2021, having achieved the XHANCE net sales and royalties threshold for Q3 2020[75] - The notes bear interest at a fixed rate of 10.75% per annum and are scheduled to mature on September 12, 2024, with quarterly interest payments and principal payments beginning December 15, 2022[79] - As of September 30, 2020, the company was in compliance with all covenants, including maintaining minimum trailing twelve-month consolidated XHANCE net sales and royalties, and at least $30 million of cash and cash equivalents[82] 10. Employee Benefit Plans This note outlines the defined contribution retirement plans maintained for US and Norway employees, and the associated costs incurred by the company - The company maintains a defined contribution 401(k) retirement plan for US employees, with approximately $105 thousand recorded in accrued liabilities for the company match as of September 30, 2020[88] - Defined contribution pension plans are maintained for Norway employees, incurring costs of $5 thousand for Q3 2020 (vs. $4 thousand in 2019) and $15 thousand for 9M 2020 (vs. $15 thousand in 2019)[89] 11. Stockholders' Equity This note reports on common stock activity, including a public offering that generated net proceeds, and details outstanding common stock warrants - On August 18, 2020, the company closed an underwritten public offering of 6,000,000 shares of common stock at $5.60 per share, resulting in $33.4 million in net proceeds[90] - As of September 30, 2020, the company had 52,080,552 shares of common stock issued and outstanding[19] - Outstanding warrants include 1,866,831 shares at an exercise price of $8.16 (expiring November 1, 2020) and 810,357 shares at $6.72 (expiring September 12, 2022)[91] 12. Stock-based Compensation This note details stock-based compensation expense, summarizes stock option and RSU activity, and describes the employee stock purchase plan | Expense Category | 3 Months Ended Sep 30, 2020 (in thousands) | 3 Months Ended Sep 30, 2019 (in thousands) | 9 Months Ended Sep 30, 2020 (in thousands) | 9 Months Ended Sep 30, 2019 (in thousands) | | :-------------------------- | :--------------------------------------- | :--------------------------------------- | :--------------------------------------- | :--------------------------------------- | | Cost of product sales | $25 | $33 | $113 | $78 | | Research and development | $334 | $90 | $922 | $617 | | General and administrative | $2,267 | $2,312 | $6,822 | $6,857 | | Total stock-based compensation | $2,626 | $2,435 | $7,857 | $7,552 | - As of September 30, 2020, 8,157,752 stock options were outstanding with a weighted average exercise price of $9.19, and 1,499,456 Restricted Stock Units (RSUs) were outstanding[95][98] - The unrecognized compensation cost related to unvested stock options was $14.1 million, to be recognized over an estimated weighted-average amortization period of 2.13 years[97] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on financial condition and results, discussing business updates, COVID-19 impact, and financial performance Company Overview This section reaffirms OptiNose's focus as a specialty pharmaceutical company in ENT and allergy, highlighting XHANCE and ongoing trials - OptiNose is a specialty pharmaceutical company focused on developing and commercializing products for patients treated by ENT and allergy specialists[104] - XHANCE is approved for the treatment of nasal polyps and is currently being evaluated in two Phase 3b clinical trials for chronic sinusitis, with top-line results expected in the second half of 2021[104] Business Updates in Response to the COVID-19 Pandemic This section details operational adjustments due to COVID-19, including virtual work, adverse impact on prescriptions, and withdrawal of revenue guidance - In mid-March 2020, the company transitioned to a full-time, virtual work environment, with sales representatives (territory managers) beginning virtual detailing of XHANCE[106] - XHANCE prescription growth was adversely impacted by the COVID-19 pandemic, particularly during 'shelter-in-place' efforts from late-March through May[106] - XHANCE prescriptions increased 11% from Q1 2020 to Q2 2020, and another 11% from Q2 2020 to Q3 2020, but the rate of growth was below pre-pandemic expectations[107] - The company withdrew its previous XHANCE revenue guidance for 2020 due to the uncertain duration and magnitude of the negative impact from the COVID-19 pandemic[107] Additional Business Updates This section provides key performance metrics for XHANCE, including prescriptions, market share, and prescribing breadth, plus manufacturing and trial updates | Metric | Q3 2020 | Q3 2019 | YoY Growth | | :-------------------------------- | :------ | :------ | :--------- | | Total XHANCE Prescriptions | 69,000 | 43,000 | 61% | | XHANCE New Prescriptions | 23,000 | 17,800 | 29% | | XHANCE Refill Prescriptions | 46,100 | 25,200 | 83% | | Physicians with ≥1 XHANCE patient fill | 6,443 | 5,075 | 27% | | Physicians with >15 XHANCE prescriptions | 1,153 | 665 | 73% | | Metric | Q3 2019 | Q4 2019 | Q1 2020 | Q2 2020 | Q3 2020 | | :---------------- | :------ | :------ | :------ | :------ | :------ | | XHANCE Market Share | 3.0% | 3.5% | 3.8% | 5.6% | 5.7% | - Manufacturing delays occurred in Q2 2020 due to COVID-19 but did not interrupt commercial or clinical supply; currently, all manufacturers are on time, and appropriate inventory levels are maintained[109] - The projected timeline for top-line results from chronic sinusitis trials remains in the second half of 2021, despite COVID-19 related pauses in patient enrollment[109] Sales, Marketing & Distribution This section outlines the company's commercial strategy for XHANCE, including sales force, co-promotion, patient programs, and distribution channels - The company has approximately 100 territory managers targeting over 10,000 ENTs, allergists, and 'specialty-like' primary care physicians, supplemented by digital and non-personal promotion[114] - A co-promotion agreement with kaléo, initiated in July 2020, expands XHANCE promotion to an additional audience of nearly 6,000 prescribers, about half of whom are outside Optinose's current target[115] - The XHANCE Co-Pay Savings Program offers eligible commercially insured patients a $0 co-pay for the first prescription and low subsequent co-pays ($0-$50); the ASSIST program for COVID-19 patients closed to new patients at the end of June 2020[116] - As of September 30, 2020, approximately 75% of commercially insured lives have contracted XHANCE coverage, though payors may impose restrictions like prior authorizations[117] XHANCE Development This section focuses on the XHANCE clinical trial program for chronic sinusitis, with top-line results expected in the second half of 2021 - The company initiated a clinical trial program to pursue a follow-on indication for XHANCE for the treatment of chronic sinusitis in the U.S., aiming to be the first FDA-approved drug therapy for this condition[119] - Top-line results from both ongoing Phase 3b chronic sinusitis trials are expected in the second half of 2021[119] OPN-019 This section announces OPN-019 development, combining EDS with an antiseptic, anticipating streamlined development due to existing components - Development of a new product candidate, OPN-019, combining the proprietary nasal Exhalation Delivery System (EDS) with an antiseptic, was initiated in June 2020[120] - In vitro testing of a candidate formulation showed a 4-log (99.99%) reduction in SARS-CoV-2 virus count[120] - Streamlined and accelerated development is anticipated because components of the drug-device combination product candidate are currently commercially available in the U.S[121] Financial Operations Overview This section overviews consolidated statements of operations components, including net product revenues, licensing revenues, and various expense categories - Net product revenues from XHANCE sales were $15.4 million for Q3 2020 and $32.8 million for 9M 2020[124] - Average net product revenues per prescription for Q3 2020 was approximately $224, an increase from $164 in Q2 2020, primarily due to reduced copay support and the sunsetting of the ASSIST program[125][126] - No licensing revenues were recognized during the three and nine months ended September 30, 2020[128][130] - Research and development expenses are expected to continue for the foreseeable future, driven by XHANCE chronic sinusitis development and other product candidates like OPN-019[133] Consolidated Results of Operations This section compares the company's financial performance for reported periods, analyzing changes in revenues, operating expenses, and net loss Comparison of three months ended September 30, 2020 and 2019 This sub-section analyzes financial performance for Q3 2020 vs. Q3 2019, highlighting increased net product revenues and a reduced net loss | Metric | Q3 2020 (in thousands) | Q3 2019 (in thousands) | Change | | :-------------------------- | :--------------------- | :--------------------- | :----- | | Net product revenues | $15,436 | $8,667 | +$6,769 | | Licensing revenues | $0 | $3,730 | -$3,730 | | Total revenues | $15,436 | $12,397 | +$3,039 | | Total operating expenses | $33,320 | $32,206 | +$1,114 | | Net loss | $(21,214) | $(28,808) | +$7,594 (reduced loss) | - Research and development expense increased by $1.0 million, primarily due to clinical expenses for XHANCE chronic sinusitis trials and pediatric studies ($0.8M), personnel costs ($0.3M), and OPN-019 regulatory expenses ($0.1M), partially offset by a $0.2 million decrease in consulting expenses[142] - Selling, general and administrative expense decreased by $0.7 million, mainly due to COVID-19 related expense delays/non-incurrence ($1.3M), decreased XHANCE sales expenses ($0.8M), and lower professional fees ($0.6M), offset by increased PPN partner service fees ($1.4M) and personnel expenses ($0.6M)[143][144] Comparison of nine months ended September 30, 2020 and 2019 This sub-section analyzes financial performance for 9M 2020 vs. 9M 2019, showing increased net product revenues and a reduced net loss | Metric | 9M 2020 (in thousands) | 9M 2019 (in thousands) | Change | | :-------------------------- | :--------------------- | :--------------------- | :----- | | Net product revenues | $32,770 | $19,320 | +$13,450 | | Licensing revenues | $0 | $4,230 | -$4,230 | | Total revenues | $32,770 | $23,550 | +$9,220 | | Total operating expenses | $99,538 | $96,230 | +$3,308 | | Net loss | $(75,922) | $(85,058) | +$9,136 (reduced loss) | - Research and development expense increased by $1.5 million, primarily due to clinical expenses for XHANCE chronic sinusitis trials and pediatric studies ($0.8M) and personnel expenses ($1.0M), partially offset by a $0.4 million decrease in consulting expenses[149] - Selling, general and administrative expense decreased by $0.3 million, mainly due to COVID-19 related expense delays/non-incurrence ($5.0M), decreased DTC marketing ($1.4M), and lower professional fees ($0.9M), offset by increased PPN partner service fees ($4.0M), personnel expenses ($1.8M), insurance/infrastructure ($0.7M), and market access ($0.6M)[150][152] Liquidity and Capital Resources This section discusses historical net losses, current cash position, cash flow activities, and future funding requirements, including debt details - The company incurred net losses of $75.9 million for the nine months ended September 30, 2020, and $85.1 million for the same period in 2019, resulting in an accumulated deficit of $503.9 million as of September 30, 2020[154] - Cash used in operating activities decreased by $5.7 million, from $72.7 million for 9M 2019 to $67.0 million for 9M 2020, primarily due to increased revenue and receivable collections[156] - Cash provided by financing activities was $63.5 million for 9M 2020, driven by $33.4 million net proceeds from a public offering and $30.0 million from the First Delayed Draw Notes[158] - The company expects its existing cash, plus an additional $20.0 million draw from the Pharmakon Note Purchase Agreement, to provide adequate capital through the receipt of top-line data from chronic sinusitis trials and fund operations into 2022[171] Off-balance sheet arrangements This section states that the company did not have any off-balance sheet arrangements during the reported periods, as defined by SEC rules and regulations - The company did not have, and does not currently have, any off-balance sheet arrangements as defined in the rules and regulations of the SEC[172] Contractual obligations and commitments This section summarizes contractual obligations as of September 30, 2020, including operating leases and long-term debt, detailing amounts and schedules | Obligation Type | Total (in thousands) | Less than 1 year (in thousands) | 1-3 years (in thousands) | 3-5 years (in thousands) | More than 5 years (in thousands) | | :------------------ | :------------------- | :------------------------------ | :----------------------- | :----------------------- | :------------------------------- | | Operating leases | $4,326 | $1,683 | $1,971 | $672 | $0 | | Long-term debt | $147,454 | $11,989 | $76,720 | $58,745 | $0 | | Total | $151,780 | $13,672 | $78,691 | $59,417 | $0 | - The company is also obligated to purchase a minimum number of products per month from one of its suppliers or potentially be subject to a payment of $5,000 per week for such month[173] Critical accounting policies This section refers to critical accounting policies and estimates in the annual Form 10-K, noting no material changes - The Critical Accounting Policies and Significant Judgments and Estimates included in the annual report on Form 10-K for the year ended December 31, 2019, have not materially changed[174] Recent accounting pronouncements This section directs readers to Note 3 of the unaudited interim consolidated financial statements for a description of recent accounting pronouncements - Refer to Note 3 to the unaudited interim consolidated financial statements for a description of recent accounting pronouncements applicable to the company's consolidated financial statements[175] JOBS Act As an emerging growth company, OptiNose irrevocably opted out of the extended transition period for new or revised accounting standards - As an 'emerging growth company,' OptiNose has irrevocably elected to 'opt out' of the extended transition period for complying with new or revised financial accounting standards[176] Item 3. Qualitative and Quantitative Disclosure About Market Risk This section states that as a smaller reporting company, OptiNose is not required to provide qualitative and quantitative disclosures about market risk - The company is a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934 and is not required to provide the information under this item[177] Item 4. Controls and Procedures This section details the evaluation of disclosure controls and procedures, concluding their effectiveness, with no material changes in internal control Evaluation of Disclosure Controls and Procedures Management, including the CEO and CFO, evaluated and concluded the effectiveness of disclosure controls and procedures as of September 30, 2020 - Disclosure controls and procedures are designed to ensure that information required to be disclosed in SEC reports is recorded, processed, summarized, and reported within specified time periods[178] - The Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective as of September 30, 2020[180] Changes in Internal Control over Financial Reporting This sub-section reports no material changes in internal control over financial reporting during the three months ended September 30, 2020 - There were no changes in internal control over financial reporting that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting during the three months ended September 30, 2020[181] Part II — Other Information Item 1A. Risk Factors This section refers to risk factors in the annual Form 10-K, with an updated focus on the adverse effects of the COVID-19 pandemic - Readers should carefully consider the risk factors described in the annual report on Form 10-K for the year ended December 31, 2019[182] - The coronavirus (COVID-19) pandemic has and may continue to adversely affect the company's business, results of operations, and financial condition[183] - Impacts of COVID-19 include hindered ability to detail XHANCE, reduced patient visits, potential negative effects on prescription growth and net revenues due to increased unemployment and changes in insurance coverage, and potential impairment of clinical trial enrollment and supply chain[184][186][187] Item 6. Exhibits This section lists exhibits filed as part of this Form 10-Q, including corporate documents, certifications, and XBRL data files - The exhibits include certifications of the Chief Executive Officer and Chief Financial Officer (Exhibits 31.1, 31.2, 32.1, 32.2)[195] - Inline XBRL Taxonomy Extension documents (Exhibits 101.SCH, 101.CAL, 101.DEF, 101.LAB, 101.PRE, 104) are filed as part of this report[195] Signatures This section contains the official signatures for the Form 10-Q report, confirming its submission by authorized personnel - The report was signed on November 5, 2020, by Keith A. Goldan, Chief Financial Officer (Principal Financial and Accounting Officer) of OptiNose, Inc[200]