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OPTN OptiNose

Optinose is a specialty pharmaceutical company focused on serving the needs of patients cared for by ear, nose and throat (ENT) and allergy specialists. Optinose has offices in the U.S. and Norway.

OPTN stock data

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Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

11 Aug 21
18 Oct 21
31 Dec 21
Quarter (USD)
Jun 21 Mar 21 Dec 20 Sep 20
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Annual (USD)
Dec 20 Dec 19 Dec 18 Dec 17
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS

Financial data from OptiNose earnings reports.

Cash burn rate (estimated) Burn method: Change in cash Burn method: Operating income/loss Burn method: FCF (opex + capex)
Last Q Avg 4Q Last Q Avg 4Q Last Q Avg 4Q
Cash on hand (at last report) 93.93M 93.93M 93.93M 93.93M 93.93M 93.93M
Cash burn (monthly) 7.36M 2.61M 6.52M 6.67M 7.5M 7.1M
Cash used (since last report) 26.63M 9.46M 23.6M 24.16M 27.15M 25.71M
Cash remaining 67.29M 84.47M 70.32M 69.76M 66.78M 68.22M
Runway (months of cash) 9.1 32.3 10.8 10.5 8.9 9.6

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
16 Sep 21 Goldan Keith A. Common Stock Sell Dispose S No No 2.789 578 1.61K 90,193
16 Sep 21 Michael F Marino III Common Stock Sell Dispose S No No 2.789 578 1.61K 98,012
16 Sep 21 Ramy A Mahmoud Common Stock Sell Dispose S No No 2.789 911 2.54K 281,765
16 Sep 21 Ramy A Mahmoud Common Stock Sell Dispose S No No 2.789 11,588 32.32K 282,676
15 Sep 21 Clavelli Victor M Common Stock Payment of exercise Dispose F No No 2.785 1,177 3.28K 139,924
15 Sep 21 Ramy A Mahmoud Common Stock Option exercise Acquire M No No 0 39,754 0 294,264
15 Sep 21 Ramy A Mahmoud RSU Common Stock Option exercise Dispose M No No 0 39,754 0 39,753
15 Sep 21 Peter K Miller Common Stock Payment of exercise Dispose F No No 2.785 2,289 6.37K 696,074
15 Sep 21 Peter K Miller Common Stock Payment of exercise Dispose F No No 2.785 21,848 60.85K 698,363
15 Sep 21 Peter K Miller Common Stock Option exercise Acquire M No No 0 79,508 0 720,211

Data for the last complete 13F reporting period. To see the most recent changes to ownership, click the ownership history button above.

70.7% owned by funds/institutions
13F holders
Current Prev Q Change
Total holders 65 68 -4.4%
Opened positions 13 13
Closed positions 16 12 +33.3%
Increased positions 18 18
Reduced positions 27 22 +22.7%
13F shares
Current Prev Q Change
Total value 137.76M 167.47M -17.7%
Total shares 37.7M 38.45M -2.0%
Total puts 0 0
Total calls 0 0
Total put/call ratio
Largest owners
Shares Value Change
Avista Capital Partners II GP 14.27M $59.09M 0.0%
FMR 7.97M $24.78M +0.3%
Entrepreneurs Fund 2.24M $9.27M 0.0%
Massachusetts Financial Services 1.77M $5.52M -0.3%
Vanguard 1.54M $4.79M -10.4%
Opaleye Management 1.23M $3.82M +48.5%
GMT Capital 1.11M $3.45M +748.6%
Rice Hall James & Associates 926.28K $2.88M -12.8%
Wasatch Advisors 773.2K $2.41M +0.3%
Millennium Management 689.75K $2.15M +939.6%
Largest transactions
Shares Bought/sold Change
BLK Blackrock 612.32K -1.84M -75.1%
GMT Capital 1.11M +979.82K +748.6%
Millennium Management 689.75K +623.4K +939.6%
Essex Investment Management 488.67K +488.67K NEW
STT State Street 94K -483.82K -83.7%
MS Morgan Stanley 448.98K +439.87K +4823.6%
Opaleye Management 1.23M +400.6K +48.5%
NTRS Northern Trust 67.97K -307.42K -81.9%
Walleye Capital 0 -272.87K EXIT
Gsa Capital Partners 357.39K +243.54K +213.9%

Financial report summary

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Risks
  • Risks Related to Our Financial Position and Capital Resources
  • We have incurred significant losses since our inception and anticipate that we will incur continued losses in the future.
  • We will likely require additional capital to fund our operations and, if we fail to obtain necessary financing, we may be unable to continue the commercialization of XHANCE and to continue the development of our other product candidates, including XHANCE for the treatment of chronic sinusitis and OPN-019.
  • Provisions of the Notes for certain potential payments to the holders of such Notes could impede a sale of the Company.
  • Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
  • Our ability to use our net operating loss carry forwards and other tax attributes may be limited.
  • Risks Related to COVID-19
  • The coronavirus (COVID-19) pandemic has and may continue to adversely affect our business, results of operations and financial condition.
  • Risks Related to Commercialization of XHANCE
  • We have a limited history of commercializing drugs, which may make it difficult for you to evaluate the success of our business to date and to assess our future viability.
  • If we are unable to successfully commercialize XHANCE, our business, financial condition and results of operations may be materially adversely affected and the price of our common stock may decline.
  • The commercial success of XHANCE will depend upon its acceptance by multiple stakeholders, including physicians, patients and healthcare payors.
  • If we are unable to differentiate XHANCE from current and future products or existing methods of treatments, our ability to successfully commercialize XHANCE would be adversely affected.
  • If the market opportunities for XHANCE are smaller than we believe, our revenue may be adversely affected, and our business may suffer.
  • Clinical practice guidelines and recommendations published by various organizations could have significant influence on the use of XHANCE.
  • We rely on PPN partners for distribution of XHANCE in the U.S., and the failure of those PPN partners to distribute XHANCE effectively would adversely affect sales of XHANCE.
  • If we cannot implement and maintain effective patient affordability programs or improve formulary access for XHANCE in the face of increasing pressure to reduce the price of medications, the adoption of XHANCE by physicians and patients may decline.
  • The negative publicity regarding specialty pharmacies or patient support service providers may result in physicians being less willing to send prescriptions to PPN partners or participate in our patient affordability programs, which would limit patient access and utilization of XHANCE.
  • We may be unable to form and maintain relationships with pharmacies that participate in our PPN and patient affordability programs, which could adversely affect the commercialization of XHANCE and our operating results.
  • Our patient affordability programs are subject to certain federal and state laws, the violation of which could have an adverse impact on our business and subject us to significant penalties.
  • If the cost of maintaining our patient affordability programs increases relative to our sales revenue, we could be forced to reduce or eliminate our financial assistance programs, which could have an adverse effect on our financial results.
  • If the FDA or other applicable regulatory authorities approve generic or similar products that compete with XHANCE, or if the FDA or other applicable regulatory authorities change or create new pathways that may expedite approval of such products, it could decrease our expected sales of XHANCE.
  • Even though we have obtained regulatory approval for XHANCE, we still face extensive FDA regulatory requirements and may face future regulatory difficulties.
  • Our relationships with physicians, patients, payors and pharmacies in the U.S. are subject to applicable anti-kickback, fraud and abuse laws and regulations. Our failure to comply with these laws could expose us to criminal, civil and administrative sanctions, reputational harm, and could harm our results of operations and financial conditions.
  • If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate Program, or other governmental pricing programs, we could be subject to additional reimbursement requirements, penalties, sanctions and fines which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
  • Regulatory approval for any approved product is limited by the FDA to those specific indications and conditions for which clinical safety and efficacy have been demonstrated.
  • Even though we have obtained FDA approval for XHANCE in the U.S., we may never obtain approval for or successfully commercialize XHANCE outside of the U.S., which would limit our ability to realize its full market potential.
  • The Affordable Care Act and any changes in healthcare law may increase the difficulty and cost for us to commercialize XHANCE and affect the prices we may obtain.
  • Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of XHANCE and any other product candidates that we may develop.
  • We are subject to intense competition and, if we are unable to compete effectively, our product candidates, if approved, may not reach their commercial potential.
  • The design and execution of clinical trials to support FDA-approval of XHANCE for the treatment of chronic sinusitis is subject to substantial risk and uncertainty.
  • The clinical and regulatory approval processes of the FDA are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business may be substantially harmed.
  • Clinical development is a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results. Clinical failure can occur at any stage of clinical development.
  • Delays in clinical trials are common and have many causes, and any delay could result in increased costs to us and jeopardize or delay our ability to obtain regulatory approval and commence product sales, or our ability to maintain regulatory approval.
  • Risks Related to Our Reliance on Third Parties
  • If we encounter difficulties in maintaining commercial manufacturing and supply agreements with our third-party manufacturers and suppliers of XHANCE, our ability to commercialize XHANCE would be impaired.
  • If we encounter issues with our contract manufacturers or suppliers, we may need to qualify alternative manufacturers or suppliers, which could impair our ability to sufficiently and timely manufacture and supply XHANCE.
  • If third-party manufacturers, wholesalers, distributors and PPN partners fail to devote sufficient time and resources to XHANCE or their performance is substandard, our product supply may be negatively impacted.
  • Manufacturing issues may arise that could increase product and regulatory approval costs or delay commercialization.
  • We rely on third parties to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, or if they terminate their agreement with us, we may not be able to obtain regulatory approval for or commercialize our product candidates.
  • Risks Related to Our Business Operations and Industry
  • Our long-term growth depends on our ability to develop and commercialize additional ENT and allergy products.
  • We are subject to risks inherent in foreign operations.
  • Our corporate structure and foreign operations may have adverse tax consequences and expose us to additional tax liabilities. In addition, tax returns we file are subject to examination by U.S. federal, state and foreign tax authorities.
  • Risks Related to Our Intellectual Property
  • If we are unable to protect our intellectual property rights or if our intellectual property rights are inadequate to protect our technology, XHANCE or our other product candidates, our competitors could develop and commercialize technology similar to ours, and our competitive position could be harmed.
  • We may become involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time consuming and unsuccessful.
  • We may not be able to protect our intellectual property rights throughout the world.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which could be uncertain and could harm our business.
  • Our competitors may be able to circumvent our patents by developing similar or alternative technologies or products in a non-infringing manner.
  • Changes in either U.S. or foreign patent law or interpretation of such laws could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • We may be subject to claims asserting that our employees, consultants, independent contractors and advisors have wrongfully used or disclosed confidential information and/or alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property.
  • Intellectual property rights do not prevent all potential threats to competitive advantages we may have.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • If our trademarks are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
  • Risks Related to Ownership of Our Common Stock
  • The price of our common stock may be volatile and you may lose all or part of your investment.
  • Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall, even if our business is doing well.
  • Future issuances of our common stock or rights to purchase common stock, including pursuant to our equity incentive plans, could result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall.
  • Our principal stockholders and management own a majority of our stock and are able to exert significant control over matters subject to stockholder approval, which could prevent new investors from influencing significant corporate decisions.
  • Some provisions of our charter documents and Delaware law may have anti-takeover effects that could discourage an acquisition of us by others, even if an acquisition would be beneficial to our stockholders, and may prevent attempts by our stockholders to replace or remove our current management.
  • Our certificate of incorporation also provides that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders' ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
  • We are an "emerging growth company" and intend to take advantage of reduced disclosure and governance requirements applicable to emerging growth companies, which could result in our common stock being less attractive to investors.
  • We may acquire other assets or businesses, or form collaborations or make investments in other companies or technologies, which could negatively impact our operating results, dilute our stockholders' ownership, increase our debt or cause us to incur significant expense.
  • Our sales force and other employees, PPN partners, CMOs, CROs, principal investigators, co-promotion partners, collaborators, independent contractors, consultants and other vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • If we fail to comply with data and privacy protection laws and regulations, we could be subject to government enforcement actions, which could include civil or criminal penalties, as well as private litigation and/or adverse publicity, any of which could negatively affect our operating results and business.
  • Our business and operations would suffer in the event of computer system failures, cyberattacks or a deficiency in our cybersecurity or those of any business partners.
Management Discussion
  • Net product revenues related to sales of XHANCE were $48.4 million and $30.4 million for the years ended December 31, 2020 and 2019, respectively. Revenue growth was attributable primarily to an increase in units sold to customers, as a result of a greater number of XHANCE prescriptions dispensed during the year ended December 31, 2020.
  • Licensing revenues were $0.8 million and $4.2 million for the years ended December 31, 2020 and 2019, respectively, as a result of payments received under the terms of the Inexia License Agreement entered into in January 2019 and the Currax License Agreement entered into in September 2019.
  • Cost of product sales related to XHANCE were $7.5 million and $5.3 million for the years ended December 31, 2020 and 2019, respectively, with the increase attributable primarily to an increase in units sold to customers, the result of a greater number of XHANCE prescriptions dispensed during the period.
Content analysis
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Positive
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Legalese
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Readability
H.S. junior Avg
New words: absence, agreed, AgreementSM, attached, buy, clarify, cohort, conclusion, constitute, copy, CS, CT, declaration, declared, diversity, entirety, exact, exceed, Exhibit, freestanding, Global, HCP, hereof, hereto, leverage, longer, modification, notice, opacification, open, percent, print, proceed, qualification, recruitment, requisite, scan, significantly, solicitation, Subtopic, suspend, text, training, transparency, unlawful
Removed: certainty, conducted, consumer, copay, front, medical, thereunder, travel, unable