Overview
- IndustryPharmaceutical Preparations2
- HeadquartersYardley, United States2
- Incorporated inDE3
- Business address777 Township Line Road, Suite 300, Yardley, Pa 190673
- Filer categoryNon-accelerated filer, Smaller reporting company3
- Legal formCorporation2
- LEI549300CPBME7Z3CYMN162
- StatusActive2
- LEI statusLapsed (not renewed)2
- Registered addressC/O Corporation Service Company, 19808 Wilmington, United States2
- Registered withDivision of Corporations, Department of State, 48291272
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W e are a specialty pharmaceutical company focused on the development and commercialization of products for patients treated by ear, nose and throat (ENT) and allergy specialists. Our first commercial product, XHANCE ® (fluticasone propionate) nasal spray, 93 microgram (mcg), is a therapeutic utilizing our proprietary Exhalation Delivery System™ (EDS ® ) that delivers a topically-acting corticosteroid for the treatment of chronic rhinosinusitis with and without nasal polyps. Chronic rhinosinusitis is a serious nasal inflammatory disease that is treated using therapies, such as intranasal steroids (INS), which have significant limitations. We believe XHANCE has a differentiated clinical profile with the potential to become part of the standard of care for this disease because it is able to deliver medication to the primary site of inflammation high and deep in the nasal passages in region…5 From its latest annual report
Financials
From the company’s reports to the SEC. Every number links to the filing it came from.
Key numbers, fiscal 2024
Where the money goes
Where each dollar of revenue went, fiscal 2024
- Cost of revenue8¢$7.2M
- Research and development4¢$3.9M
- Selling, general and admin88¢$83.5M
Out of $78.2M in revenue.6 The company lost money this year.
Financial statements
| Fiscal year | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 |
|---|---|---|---|---|---|---|---|
| Revenue | $7.1M7 | $34.6M8 | $49.1M9 | $74.7M10 | $76.3M11 | $71.0M6 | $78.2M6 |
| Cost of revenue | $1.6M7 | $5.3M8 | $7.5M9 | $9.2M10 | $9.3M11 | $8.6M6 | $7.2M6 |
| Gross profit | $5.5M12 | ||||||
| Research and development | $10.1M7 | $20.8M8 | $23.4M9 | $25.3M10 | $15.3M11 | $5.3M6 | $3.9M6 |
| Selling, general and admin | $95.6M7 | $104.2M8 | $105.4M9 | $106.6M10 | $107.6M11 | $79.8M6 | $83.5M6 |
| Operating expenses | $141.1M10 | $132.2M11 | $93.7M6 | $94.5M6 | |||
| Operating income | -$100.2M7 | -$95.6M8 | -$87.2M9 | -$66.5M10 | -$55.9M11 | -$22.7M6 | -$16.3M6 |
| Interest | $9.2M7 | $9.6M8 | $13.0M9 | $16.0M10 | $16.8M11 | $19.5M11 | |
| Income before tax | -$82.3M10 | -$74.8M11 | -$35.5M6 | -$21.5M6 | |||
| Income tax | |||||||
| Net income | -$106.7M7 | -$110.1M8 | -$99.8M9 | -$82.3M10 | -$74.8M11 | -$35.5M6 | -$21.5M6 |
| Earnings per share | -$2.6812 | -$2.079 | -$1.4510 | -$0.8711 | -$4.756 | -$2.126 | |
| Earnings per share (diluted) | -$2.6812 | -$2.079 | -$1.4510 | -$0.8711 | -$4.756 | -$2.126 | |
| Shares (weighted, basic) | 56.9M shares10 | 85.9M shares11 | 7.5M shares6 | 10.2M shares6 | |||
| Shares (weighted, diluted) | 56.9M shares10 | 85.9M shares11 | 7.5M shares6 | 10.2M shares6 |
| Fiscal year | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 |
|---|---|---|---|---|---|---|---|
| Cash | $201.0M12 | $147.2M9 | $144.2M10 | $110.5M11 | $94.2M6 | $73.7M6 | $84.5M6 |
| Receivables | $35.4M10 | $33.9M11 | $19.9M6 | $26.4M6 | |||
| Inventory | $11.8M10 | $9.4M11 | $8.1M6 | $11.5M6 | |||
| Current assets | $212.9M7 | $168.1M8 | $180.7M9 | $160.4M10 | $140.5M11 | $105.3M6 | $125.8M6 |
| Property, plant and equipment | $1.3M10 | $795.0K11 | $815.0K6 | $605.0K6 | |||
| Total assets | $217.0M7 | $172.7M8 | $188.8M9 | $166.1M10 | $144.2M11 | $107.7M6 | $128.8M6 |
| Accounts payable | $8.0M10 | $5.3M11 | $3.9M6 | $450.0K6 | |||
| Short-term debt | $010 | $128.6M11 | $130.2M11 | $126.5M6 | |||
| Current liabilities | $25.7M7 | $36.1M8 | $52.2M9 | $59.2M10 | $178.7M11 | $176.5M6 | $162.8M6 |
| Long-term debt | $72.5M7 | $74.5M8 | $125.2M9 | $126.4M10 | $010 | ||
| Total liabilities | $98.4M7 | $111.1M8 | $182.0M9 | $187.8M10 | $200.8M11 | $194.3M6 | $169.1M6 |
| Retained earnings | -$610.1M10 | -$684.9M11 | -$720.4M6 | -$741.9M6 | |||
| Shareholders’ equity | $118.6M7 | $61.6M8 | $6.8M10 | -$21.8M11 | -$56.6M6 | -$86.6M6 | -$40.4M6 |
| Shares outstanding | 41.2M shares7 | 52.9M shares8 | 52.9M shares9 | 82.2M shares10 | 111.5M shares11 | 7.5M shares6 | 10.1M shares6 |
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
| Fiscal year | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 |
|---|---|---|---|---|---|---|---|
| Cash from operations | -$91.8M7 | -$90.8M8 | -$86.2M9 | -$76.9M10 | -$67.7M11 | -$20.5M6 | -$44.7M6 |
| Depreciation and amortization | $646.0K10 | $532.0K11 | $402.0K6 | $283.0K6 | |||
| Stock-based compensation | $10.0M10 | $8.9M11 | $5.2M6 | $6.5M6 | |||
| Capital spending | $1.7M7 | $557.0K8 | $546.0K9 | $167.0K10 | $63.0K11 | $328.0K6 | $72.0K6 |
| Free cash flow | -$93.5M | -$91.4M | -$86.8M | -$77.1M | -$67.7M | -$20.9M | -$44.8M |
| Cash from investing | -$62.0K10 | -$63.0K11 | -$328.0K6 | -$72.0K6 | |||
| Cash from financing | $43.3M10 | $51.4M11 | $300.0K6 | $55.6M6 | |||
| Dividend per share | $0.0012 | $0.007 | $0.008 | $0.009 | $0.0010 | $0.0011 |
Corporate structure
OptiNose, Inc. sits at the top of its group. 2 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.
Major holders of OptiNose, Inc.
- Nantahala Capital Management, LLC Filed SCHEDULE 13G/A on OptiNose, Inc., latest Aug 14, 2025 (3 filings since Nov 14, 2024)
- Rosalind Advisors, Inc. Filed SCHEDULE 13G/A on OptiNose, Inc., latest Aug 11, 2025 (9 filings since Jul 28, 2023)
- FMR LLC Filed SCHEDULE 13G/A on OptiNose, Inc., latest Jun 6, 2025 (5 filings since Feb 9, 2022)
- GREAT POINT PARTNERS LLC Filed SCHEDULE 13G/A on OptiNose, Inc., latest May 15, 2025 (6 filings since Dec 1, 2022)
- Stonepine Capital Management, LLC Filed SCHEDULE 13G/A on OptiNose, Inc., latest May 14, 2025 (3 filings since Nov 20, 2024)
- KINGDON CAPITAL MANAGEMENT, L.L.C. Filed SCHEDULE 13G on OptiNose, Inc., latest Apr 14, 2025
- ACORN BIOVENTURES, L.P. Filed SC 13G/A on OptiNose, Inc., latest Feb 13, 2024 (2 filings since Dec 5, 2022)
- KRUTTSCHNITT THEODORE H III Filed SC 13G/A on OptiNose, Inc., latest Feb 7, 2024 (4 filings since Feb 2, 2022)
- Avista Capital Partners II GP, LLC Filed SC 13G/A on OptiNose, Inc., latest Jan 30, 2024 (2 filings since Feb 8, 2022)
- MVM Partners, LLC Filed SC 13D/A on OptiNose, Inc., latest Feb 14, 2023 (2 filings since Nov 23, 2022)
- MVM Partners LLP Filed SC 13D on OptiNose, Inc., latest Dec 27, 2021
- OptiNose, Inc. Yardley, Pennsylvania, United States
- OptiNose US, Inc. Subsidiary · Delaware, United States
Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What OptiNose, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.
Property and equipment
| Item | Latest | A year before | Change |
|---|---|---|---|
| Property and equipment, before depreciation | $5.8M6 Dec 31, 2024 | $5.7M6 Dec 31, 2023 | +1.3% |
| Accumulated depreciation | $5.1M6 Dec 31, 2024 | $4.9M6 Dec 31, 2023 | +5.8% |
| Property and equipment, net | $605.0K6 Dec 31, 2024 | $815.0K6 Dec 31, 2023 | −25.8% |
| Operating-lease assets (leased space) | $2.3M6 Dec 31, 2024 | $1.5M6 Dec 31, 2023 | +54.6% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $84.5M6 Dec 31, 2024 | $73.7M6 Dec 31, 2023 | +14.7% |
Inventory
| Item | Latest | A year before | Change |
|---|---|---|---|
| Inventory, total | $11.5M6 Dec 31, 2024 | $8.1M6 Dec 31, 2023 | +42.4% |
| Raw materials | $1.7M6 Dec 31, 2024 | $2.4M6 Dec 31, 2023 | −28.0% |
| Work in process | $7.8M6 Dec 31, 2024 | $3.3M6 Dec 31, 2023 | +138.7% |
| Finished goods | $1.9M6 Dec 31, 2024 | $2.4M6 Dec 31, 2023 | −19.7% |
Properties, in its own words
Our principal office is located in Yardley, Pennsylvania, where we lease approximately 19,780 square feet of office space pursuant to a lease that expires in May 2027. We also lease office space in Ewing, New Jersey. We believe our facilities are adequate to meet our current needs, although we may seek to negotiate new leases or evaluate additional or alternate space for our operations.
Item 2 of the 10-K filed Mar 26, 2025.5
Leadership
Who has led OptiNose, Inc., and when. Pick a name to see everywhere that person has worked.
Chief executive
President
Chief financial officer
Chief operating officer
- Chief executive officerRamy A. Mahmoud Feb 2, 2023 to now16
- Chief executive officerPeter K. Miller Oct 12, 2017 to Jan 17, 202317
- PresidentRamy A. Mahmoud Oct 12, 2017 to Jan 17, 202318
- Chief financial officerTerry Kohler Oct 7, 2024 to now19
- Chief financial officerMichele Janis Jun 10, 2022 to Dec 19, 202220
- Chief financial officerKeith A. Goldan Oct 12, 2017 to Mar 17, 202221
- Chief operating officerRamy A. Mahmoud Oct 12, 2017 to Jan 17, 202318
Board members and other officers (18)
- Chief Accounting OfficerAnthony J. Krick Jun 10, 2022 to now22
- Chief Commercial OfficerPaul Spence Jr. Dec 15, 2022 to now23
- Chief Commercial OfficerVictor M. Clavelli Feb 20, 2020 to Dec 19, 202224
- Board memberRamy A. Mahmoud Feb 2, 2023 to now16
- Board memberR. John Fletcher Apr 26, 2022 to now25
- Board memberEric Bednarski Dec 13, 2021 to now26
- Board memberKyle Dempsey Dec 13, 2021 to now27
- Board memberCatherine E. Owen Jul 30, 2020 to now28
- Board memberTomas J. Heyman Dec 4, 2020 to now29
- Board memberSandra L. Helton Feb 22, 2018 to now30
- Board memberRobert P. O'Neil Jun 11, 2018 to Jun 12, 202031
- Board memberJoseph C. Scodari Oct 12, 2017 to Jun 9, 202232
- Board memberJoshua Alexander Tamaroff Oct 12, 2017 to Jun 12, 202033
- Board memberLarry G. Pickering Oct 12, 2017 to Feb 7, 201834
- Board memberPeter K. Miller Oct 12, 2017 to Jan 17, 202317
- Board memberRick Bierly Oct 12, 2017 to Oct 16, 201735
- Board memberSriram Venkataraman Oct 12, 2017 to Jun 12, 202036
- Board memberWilhelmus Cm Groenhuysen Oct 12, 2017 to now37
Named in SEC Form D filings
People the company listed in its private-offering notices.
- Chief Legal Officer and Corporate SecretaryMichael F. Marino named Nov 30, 2021 to May 20, 202438
Subsidiaries and ownership
Subsidiaries (Exhibit 21)
- OptiNose US, Inc. Delaware4
The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.
Timeline
- May 21, 20258-K Ended a material agreement; Completed an acquisition or sale; Listing notice or transfer39
- May 16, 20258-K Shareholder vote40
- Mar 26, 20258-K Results of operations41
- Mar 20, 20258-K Other events42
- Mar 20, 20258-K Entered a material agreement43
- Jan 15, 20258-K Results of operations44
- Dec 30, 20248-K Change to shareholders' rights; Bylaws or fiscal year changed45
- Dec 23, 20248-K Shareholder vote46
- Nov 12, 20248-K Results of operations; Other events47
- Oct 16, 20248-K Listing notice or transfer48
- Oct 8, 20248-K Executive or director change49
- Sep 25, 20248-K Executive or director change50
- Feb 2, 2023New chief executive Ramy A. Mahmoud becomes CEO16
- Oct 12, 2017New chief executive Peter K. Miller becomes CEO17
- May 26, 2010Founded OptiNose, Inc. is founded2
Calendar
When it reported results
- Mar 26, 2025Reported quarterly or annual results41
- Jan 15, 2025Reported quarterly or annual results44
- Nov 12, 2024Reported quarterly or annual results47
- Aug 8, 2024Reported quarterly or annual results51
- May 14, 2024Reported quarterly or annual results52
- May 9, 2024Reported quarterly or annual results53
- Apr 25, 2024Reported quarterly or annual results54
- Mar 7, 2024Reported quarterly or annual results55
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
307 filings to the SEC since October 2021: 5 annual reports, 11 quarterly reports, 61 major events, 118 insider forms, 38 large holders, 2 private raises, 72 other. The latest 20:
- Aug 14, 2025SCHEDULE 13G/A EDGAR
- Aug 11, 2025SCHEDULE 13G/A EDGAR
- Jun 6, 2025SCHEDULE 13G/A EDGAR
- Jun 2, 202515-12G EDGAR
- May 21, 2025EFFECT EDGAR
- May 21, 2025EFFECT EDGAR
- May 21, 2025EFFECT EDGAR
- May 21, 2025EFFECT EDGAR
- May 21, 2025EFFECT EDGAR
- May 21, 2025EFFECT EDGAR
- May 21, 2025EFFECT EDGAR
- May 21, 2025S-8 POS EDGAR
- May 21, 2025S-8 POS EDGAR
- May 21, 2025S-8 POS EDGAR
- May 21, 2025S-8 POS EDGAR
- May 21, 2025S-8 POS EDGAR
- May 21, 2025S-8 POS EDGAR
- May 21, 2025S-8 POS EDGAR
- May 21, 2025S-8 POS EDGAR
- May 21, 2025S-8 POS EDGAR
The 307 filings since October 2021 can be filtered by form type and year here when JavaScript is on.
Every filing from the last five years, summarized. The full record is on SEC EDGAR.
Insider trades
61 open-market trades by officers, directors and large owners since October 2021: 0 buys and 61 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Mar 18, 2025 | Marino Michael F IIIChief Legal Officer & Corp Sec | Sale | 246 | $5.61 | $1.4K | Form 4 |
| Mar 18, 2025 | Mahmoud Ramy AChief Executive Officer | Sale | 368 | $5.61 | $2.1K | Form 4 |
| Mar 4, 2025 | Spence Paul Jr.Chief Commercial Officer | Sale | 1,223 | $5.29 | $6.5K | Form 4 |
| Mar 4, 2025 | Marino Michael F IIIChief Legal Officer & Corp Sec | Sale | 2,145 | $5.29 | $11.3K | Form 4 |
| Mar 4, 2025 | Mahmoud Ramy AChief Executive Officer | Sale | 6,376 | $5.29 | $33.7K | Form 4 |
| Dec 17, 2024 | Marino Michael F IIIChief Legal Officer & Corp Sec | Sale | 3,050 | $0.44 | $1.3K | Form 4 |
| Dec 17, 2024 | Mahmoud Ramy AChief Executive Officer | Sale | 4,614 | $0.44 | $2.0K | Form 4 |
| Sep 17, 2024 | Marino Michael F IIIChief Legal Officer & Corp Sec | Sale | 3,226 | $0.87 | $2.8K | Form 4 |
| Sep 17, 2024 | Mahmoud Ramy AChief Executive Officer | Sale | 4,881 | $0.87 | $4.2K | Form 4 |
| Jul 17, 2024 | Krick Anthony JChief Accounting Officer | Sale | 6,845 | $1.14 | $7.8K | Form 4 |
| Jul 17, 2024 | Marino Michael F IIIChief Legal Officer & Corp Sec | Sale | 49,408 | $1.14 | $56.3K | Form 4 |
| Jul 17, 2024 | Mahmoud Ramy AChief Executive Officer | Sale | 111,426 | $1.14 | $127.0K | Form 4 |
| Jun 18, 2024 | Krick Anthony JChief Accounting Officer | Sale | 624 | $1.19 | $743 | Form 4 |
| Jun 18, 2024 | Marino Michael F IIIChief Legal Officer & Corp Sec | Sale | 2,946 | $1.19 | $3.5K | Form 4 |
| Jun 18, 2024 | Marino Michael F IIIChief Legal Officer & Corp Sec | Sale | 3,267 | $1.19 | $3.9K | Form 4 |
| Jun 18, 2024 | Mahmoud Ramy AChief Executive Officer | Sale | 18,987 | $1.19 | $22.6K | Form 4 |
| Mar 18, 2024 | Krick Anthony JChief Accounting Officer | Sale | 2,345 | $1.88 | $4.4K | Form 4 |
| Mar 18, 2024 | Marino Michael F IIIChief Legal Officer & Corp Sec | Sale | 15,059 | $1.88 | $28.3K | Form 4 |
| Mar 18, 2024 | Mahmoud Ramy AChief Executive Officer | Sale | 19,198 | $1.88 | $36.1K | Form 4 |
| Jan 31, 2024 | Mahmoud Ramy AChief Executive Officer | Sale | 52,875 | $1.31 | $69.3K | Form 4 |
All 61 trades can be filtered by person here when JavaScript is on.
From Forms 4 filed with the SEC.
Major holders
Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.
- Nantahala Capital Management, LLCSCHEDULE 13G/A, 3 filings Nov 14, 2024 to Aug 14, 202556
- Rosalind Advisors, Inc.SCHEDULE 13G/A, 9 filings Jul 28, 2023 to Aug 11, 202557
- FMR LLCSCHEDULE 13G/A, 5 filings Feb 9, 2022 to Jun 6, 202558
- GREAT POINT PARTNERS LLCSCHEDULE 13G/A, 6 filings Dec 1, 2022 to May 15, 202559
- Stonepine Capital Management, LLCSCHEDULE 13G/A, 3 filings Nov 20, 2024 to May 14, 202560
- KINGDON CAPITAL MANAGEMENT, L.L.C.SCHEDULE 13G, 1 filing Apr 14, 202561
- ACORN BIOVENTURES, L.P.SC 13G/A, 2 filings Dec 5, 2022 to Feb 13, 202462
- KRUTTSCHNITT THEODORE H IIISC 13G/A, 4 filings Feb 2, 2022 to Feb 7, 202463
- Avista Capital Partners II GP, LLCSC 13G/A, 2 filings Feb 8, 2022 to Jan 30, 202464
- MVM Partners, LLCSC 13D/A, 2 filings Nov 23, 2022 to Feb 14, 202365
- MVM Partners LLPSC 13D, 1 filing Dec 27, 202166
Funding
Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.
- Private raises (Form D) $8.7M
Figures by year
| Year | Private raises (Form D) | Total |
|---|---|---|
| 2024 | $4.7M | $4.7M |
| 2021 | $4.0M | $4.0M |
Private raises
Private offerings the company reported to the SEC on Form D. The amount is what the latest filing says was sold so far, charted in the year of the first sale. Covers filings since Oct 1, 2021.
SEC filer profile
How OptiNose, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGAROptiNose, Inc.1
- CIK0001494650
- Employer ID (EIN)42-17716105
- Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company5
- Incorporated inDelaware5
- Fiscal year endsDecember 311
- Industry code (SIC)2834 Pharmaceutical Preparations1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business address777 Township Line Road, Suite 300, Yardley, PA 190671
- Phone267-364-35001
- Shares outstanding10,127,381 as of May 1, 202515
- Public float$139.8M as of Jun 28, 20245
- AuditorErnst & Young LLP, Philadelphia, PA PCAOB ID 42; no auditor attestation of internal control over financial reporting5
- On EDGAR sinceJun 21, 20101
- Filings631 in all: 4 (228), 8-K (121), SC 13G/A (31), 3 (28), 10-Q (23), SC 13G (17), 144 (13), CORRESP (13)1
All 44 form types
DEFA14A (12), EFFECT (12), 424B5 (11), SCHEDULE 13G/A (10), DEF 14A (9), S-8 (9), S-8 POS (9), 10-K (8), D (8), UPLOAD (8), 4/A (7), 5 (7), POS AM (7), CT ORDER (3), DRSLTR (3), S-1/A (3), S-3 (3), 424B4 (2), DRS (2), DRS/A (2), PRE 14A (2), S-1 (2), S-1MEF (2), SC 13D/A (2), SCHEDULE 13G (2), SEC STAFF LETTER (2), 10-K/A (1), 15-12G (1), 25-NSE (1), 8-A12B (1), 8-K/A (1), CERTNAS (1), D/A (1), DEFM14A (1), PREM14A (1), SC 13D (1)
- Latest filingsAnnual report (10-K) Mar 26, 2025
Quarterly report (10-Q) May 14, 2025
Proxy statement (DEF 14A) Dec 12, 2024
Latest 8-K (8-K) May 21, 2025
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, $0.001 par value | OPTN | The Nasdaq Global Select Market |
From the cover page of the 10-K filed Mar 26, 2025 (Section 12(b) of the Exchange Act).5
Risk factors and legal proceedings
The risks OptiNose, Inc. names in Item 1A of its 10-K filed Mar 26, 2025: 71 risks under these headings, as written.5
- Risks Related to Our Financial Position and Capital Resources
- We have identified conditions and events that raise substantial doubt about our ability to continue as a going concern.
- We have incurred significant losses since our inception and anticipate that we will incur continued losses in the future.
- We may never achieve or maintain profitability.
- 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 service and repay our debt.
- Our failure to comply with the covenants or other terms of the A&R Note Purchase Agreement, including as a result of events beyond our control, could result in a default under the A&R Note Purchase Agreement that could materially and adversely affect the ongoing viability of our business.
- Our A&R Note Purchase Agreement contains restrictions that limit our flexibility in operating our business.
- Provisions of the Pharmakon Senior Secured Notes and the 2022 Warrants provide for certain potential payments to the holders of such securities which 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.
- We have a significant number of warrants outstanding that contain anti-dilution provisions that may result in the reduction of their exercise prices in the future.
- Our ability to use our net operating loss carry forwards and other tax attributes may be limited.
- Risks Related to Commercialization of XHANCE
The other 61 risks
- 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 depends upon its acceptance by multiple stakeholders, including physicians, patients and third-party payors.
- If third-party payors do not reimburse patients for XHANCE or if reimbursement levels are set too low for us to sell XHANCE at a profit, our ability to successfully commercialize XHANCE and our results of operations will be harmed.
- If we are unable to differentiate XHANCE from current and future products or existing methods of treatments, our ability to successfully commercialize XHANCE will be adversely affected.
- If the market opportunities for XHANCE are smaller than we believe, our revenue potential 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.
- A significant portion of our sales are to a limited number of PPN partners and pharmaceutical wholesalers. Changes in terms required by these PPN partners or wholesalers, disruptions in these relationships or a default could harm our results of operations and financial condition.
- We rely on HUB and PPN partners for distribution of XHANCE in the U.S., and the failure of those HUB and 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, HUB and other patient support service providers may result in physicians being less willing to send prescriptions to our HUB or 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 Hub, 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.
- XHANCE may become associated with undesirable adverse reactions or have other properties that could result in significant negative consequences following regulatory approval.
- 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 for the treatment of chronic rhinosinusitis with or without nasal polyps 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 other healthcare reform measures 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.
- Risks Related to Clinical Development and Regulatory Approval
- 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, HUB 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.
- 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.
- Changes in U.S. and international trade policies may adversely impact our business and operating results.
- 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 any of our future 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 substantial percentage of our stock and are able to exert significant control over matters subject to stockholder approval, which could prevent other 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.
- Risks Related to the Merger
- Failure to complete the Merger could negatively affect the price of our common stock, as well as our future business and financial results.
- Expenses related to the proposed Merger are significant and will adversely affect our operating results.
- We are subject to business uncertainties and contractual restrictions while the Merger is pending, which could adversely affect our business.
- Uncertainties associated with the Merger may cause a loss of management and other key employees and disrupt our business relationships, which could adversely affect our business.
- The Merger Agreement limits our ability to pursue alternatives to the Merger and may discourage other companies from trying to acquire us for greater consideration than what Paratek has agreed to pay.
- General Risk Factors
- 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, HUB, 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.
- We may be exposed to liabilities under the U.S. Foreign Corrupt Practices Act and other U.S. and foreign anti-corruption anti-money laundering, export control, sanctions, and other trade laws and regulations, and any determination that we violated these laws could have a material adverse effect on our business.
Legal proceedings
We are not currently a party to any material pending legal proceedings.
The opening of Item 3, Legal Proceedings.5
Sources
The numbers on this page point here. Each one links to the record it came from.
- 1SEC EDGAROptiNose, Inc. filings on SEC EDGAR
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- 3SEC EDGAROptiNose, Inc. filings on SEC EDGAR
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- 6SEC EDGAROptiNose, Inc. 10-K for fiscal 2024
- 7SEC EDGAROptiNose, Inc. 10-K for fiscal 2018
- 8SEC EDGAROptiNose, Inc. 10-K for fiscal 2019
- 9SEC EDGAROptiNose, Inc. 10-K for fiscal 2020
- 10SEC EDGAROptiNose, Inc. 10-K for fiscal 2021
- 11SEC EDGAROptiNose, Inc. 10-K for fiscal 2022
- 12SEC EDGAROptiNose, Inc. 10-K for fiscal 2018
- 13SEC EDGAROptiNose, Inc. 10-Q for fiscal 2024
- 14SEC EDGAROptiNose, Inc. 10-Q for fiscal 2024
- 15SEC EDGAROptiNose, Inc. 10-Q for fiscal 2025
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- 18SEC EDGARRamy A. Mahmoud, President
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- 25SEC EDGARR. John Fletcher, Board member
- 26SEC EDGAREric Bednarski, Board member
- 27SEC EDGARKyle Dempsey, Board member
- 28SEC EDGARCatherine E. Owen, Board member
- 29SEC EDGARTomas J. Heyman, Board member
- 30SEC EDGARSandra L. Helton, Board member
- 31SEC EDGARRobert P. O'Neil, Board member
- 32SEC EDGARJoseph C. Scodari, Board member
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- 34SEC EDGARLarry G. Pickering, Board member
- 35SEC EDGARRick Bierly, Board member
- 36SEC EDGARSriram Venkataraman, Board member
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- 40SEC EDGARShareholder vote
- 41SEC EDGARResults of operations
- 42SEC EDGAROther events
- 43SEC EDGAREntered a material agreement
- 44SEC EDGARResults of operations
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- 46SEC EDGARShareholder vote
- 47SEC EDGARResults of operations; Other events
- 48SEC EDGARListing notice or transfer
- 49SEC EDGARExecutive or director change
- 50SEC EDGARExecutive or director change
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