0001494650false00014946502025-03-262025-03-26

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
____________________________________________________________________________________________

FORM 8-K
____________________________________________________________________________________________

CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 26, 2025
__________________________________________________________________________________________

optinoselogorgba31.jpg
OPTINOSE, INC.
(Exact Name of Registrant as Specified in its Charter)
____________________________________________________________________________________________
Delaware001-3824142-1771610
(State or Other Jurisdiction of Incorporation or Organization)(Commission File No.)(I.R.S. Employer Identification No.)

777 Township Line Road, Suite 300
Yardley, Pennsylvania 19067
(Address of principal executive offices and zip code)

(267) 364-3500
(Registrant’s telephone number, including area code)
(Former name or former address, if changed from last report)
____________________________________________________________________________________________

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
  
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
  
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
  
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-14(c))
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
☐Emerging growth company
☐If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading symbol(s)Name of each exchange on which registered
Common stock, par value $0.001 per shareOPTNNasdaq Global Select Market





Item 2.02 Results of Operations and Financial Condition.

On March 26, 2025, OptiNose, Inc. (the “Company”) issued a press release announcing its financial results for the quarter and year ended December 31, 2024. A copy of the press release is attached as Exhibit 99.1 to this report and is incorporated herein by reference.


* * *

The information included in Item 2.02 (including Exhibit 99.1) of this Form 8-K, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any Company filing under the Securities Act or the Exchange Act, except as expressly set forth by specific reference in such a filing.


Item 9.01 Financial Statements and Exhibits.

(d)    Exhibits
Exhibit No. Description
99.1
104
Cover Page Interactive Data File (embedded within the Inline XBRL document)




SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.
 
   
  OptiNose, Inc.
By: /s/ Terry Kohler
  Terry Kohler
  Chief Financial Officer
Date: March 26, 2025


image_0.jpg

Optinose Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Operational Highlights

Company reports fourth quarter and full year 2024 XHANCE net revenue of $22.4 million and $78.2 million, increases of 13% and 10% compared to prior year periods

Company reports 23% prescription growth from third quarter 2024 to fourth quarter 2024

YARDLEY, Pa., March 26, 2025 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 quarter and year ended December 31, 2024, and provided recent operational highlights.

Fourth Quarter 2024 and Recent Highlights

New Prescriptions (NRx) and Total Prescriptions (TRx)
An inflection in prescription demand first observed in September 2024 NRx continued in fourth quarter 2024 and extended to TRx. NRx increased 12% from approximately 25,600 in third quarter 2024 to approximately 28,700 in fourth quarter 2024. TRx increased 23% from approximately 63,900 in third quarter 2024 to approximately 78,500 in fourth quarter 2024.

Fourth Quarter 2024 Financial Results

Revenues
The Company reported $22.4 million in net revenue from sales of XHANCE during the three-month period ended December 31, 2024, an increase of 13% compared to $19.9 million during the three-month period ended December 31, 2023. For the twelve-month period ended December 31, 2024, the Company reported $78.2 million in net revenue from sales of XHANCE, an increase of 10% compared to $71.0 million during the twelve-month period ended December 31, 2023.

Costs and expenses and net loss
For the three-month and twelve-month periods ended December 31, 2024, research and development expenses were $0.8 million and $3.9 million, respectively. Selling, general and administrative expenses were $19.3 million and $83.5 million during the three-month and twelve-month periods ended December 31, 2024, respectively. In total, SG&A plus R&D expenses increased by $2.2 million, to $87.3 million for the twelve-month period ended December 31, 2024 when compared to the twelve-month period ended December 31, 2023 total of $85.1 million.

Income from operations was for the three-month period ended December 31, 2024, was $0.4 million. This is the first three-month period in which the Company reported income from operations.

The net loss for the three-month period ended December 31, 2024 was $0.4 million, or $0.04 per share (basic and diluted). The net loss for the twelve-month period ended December 31, 2024 was $21.5 million, or $2.12 per share (basic and diluted).












Balance Sheet
The Company had cash and cash equivalents of $84.5 million as of December 31, 2024.




OptiNose, Inc.
Condensed Consolidated Statement of Operations
(in thousands, except share and per share data)
(Unaudited)
Three Months EndedYear Ended
December 31,December 31,
2024202320242023
Revenues:
Net product revenues$22,418 $19,865 $78,226 $70,987 
Total revenues22,418 19,865 78,226 70,987 
Costs and expenses:
Cost of product sales$1,954 $2,131 $7,231 $8,633 
Research and development7721,2863,855 5,303 
Selling, general and administrative19,338 18,960 83,459 79,799 
Total costs and expenses22,064 22,377 94,545 93,735 
Income (loss) from operations354 (2,512)(16,319)(22,748)
Other (income) expense714 7,455 5,222 12,735 
Net (loss)$(360)$(9,967)$(21,541)$(35,483)
Net loss per share of common stock, basic and diluted$(0.03)$(1.33)$(2.12)$(4.75)
Weighted average common shares outstanding, basic and diluted11,635,909 7,487,465 10,156,745 7,472,035 






















OptiNose, Inc.
Condensed Consolidated Balance Sheet Data
(in thousands)
December 31December 31,
20242023
Cash and cash equivalents$84,485$73,684
Other assets44,30034,045
Total assets$128,785$107,729
Total current liabilities (1)
$162,813$176,524
Other liabilities6,33217,811
Total stockholders' deficit(40,360)(86,606)
Total liabilities and stockholders' deficit$128,785$107,729
(1) – All outstanding principal and fees payable upon maturity have been classified as a current liability in accordance with Generally Accepted Accounting Principles ("GAAP") because, as of the date hereof, the Company believes that it is probable that it will not maintain compliance with certain financial covenants contained in its Amended and Restated Note Purchase Agreement for at least the next 12-months. As a result, the Company's audited financial statements for the year ended December 31, 2024 (“2024 Audited Financial Statements”) will state that there is substantial doubt about the Company's ability to continue as a going concern (i.e., a "going concern" paragraph). Please refer to the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 (including the 2024 Audited Financial Statements) which will be filed after the issuance of this press release for additional information..

About 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. To learn more, please visit www.optinose.com or follow us on Twitter and LinkedIn.

About XHANCE
XHANCE is a drug-device combination product that uses the Exhalation Delivery System™ (also referred to as the EDS®) designed to deliver a topical steroid to the high and deep regions of the nasal cavity where sinuses ventilate and drain. XHANCE is approved by the U.S. Food and Drug Administration for both the treatment of chronic rhinosinusitis without nasal polyps (also called chronic sinusitis) and chronic rhinosinusitis with nasal polyps (also called nasal polyps) in patients 18 years of age or older.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS: Hypersensitivity to any ingredient in XHANCE.
WARNINGS AND PRECAUTIONS:
•Local nasal adverse reactions, including epistaxis, erosion, ulceration, septal perforation, Candida albicans infection, and impaired wound healing, can occur. Monitor patients periodically for signs of possible changes on the nasal mucosa. Avoid use in patients with recent nasal ulcerations, nasal surgery, or nasal trauma until healing has occurred.
•Glaucoma and cataracts may occur with long-term use. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use XHANCE long-term.
•Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, contact dermatitis, rash, hypotension, and bronchospasm) have been reported after administration of fluticasone propionate. Discontinue XHANCE if such reactions occur.




















•Immunosuppression and infections can occur, including potential increased susceptibility to or worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infection; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.
•Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue XHANCE slowly.
•Assess for decrease in bone mineral density initially and periodically thereafter.

ADVERSE REACTIONS:
•Chronic rhinosinusitis without nasal polyps: The most common adverse reactions (incidence ≥3%) are epistaxis, headache, and nasopharyngitis.
•Chronic rhinosinusitis with nasal polyps: The most common adverse reactions (incidence ≥3%) are epistaxis, nasal septal ulceration, nasopharyngitis, nasal mucosal erythema, nasal mucosal ulcerations, nasal congestion, acute sinusitis, nasal septal erythema, headache, and pharyngitis.

DRUG INTERACTIONS: Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. May increase risk of systemic corticosteroid effects.

USE IN SPECIFIC POPULATIONS: Hepatic impairment. Monitor patients for signs of increased drug exposure.
Please see full Prescribing Information, including Instructions for Use





















Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. All statements that are not historical facts are hereby identified as forward-looking statements for this purpose and include, among others, statements relating to the potential benefits of XHANCE; the potential benefits of the Exhalation Delivery System; the Company's belief that it is probable that it will not maintain compliance with certain financial covenants contained in its Amended and Restated Note Purchase Agreement for at least the next 12-months and the consequences thereof; and other statements regarding the Company's future operations, financial performance, financial position, prospects, objectives, strategies and other future events. Forward-looking statements are based upon management’s current expectations and assumptions and are subject to a number of risks, uncertainties and other factors that could cause actual results and events to differ materially and adversely from those indicated by such forward-looking statements including, among others: physician and patient acceptance of XHANCE for its new indication; the Company’s ability to maintain adequate third-party reimbursement for XHANCE (including its new indication); the prevalence of chronic sinusitis and market opportunities for XHANCE may be smaller than expected; the Company’s ability to efficiently generate XHANCE prescriptions and net revenues; unanticipated costs and expenses; the risk that the positive inflection in new XHANCE prescriptions starting in September does not continue and grow; the Company’s ability to comply with the covenants and other terms of its Amended and Restated Note Purchase Agreement; the Company’s ability to continue as a going concern; risks and uncertainties relating to intellectual property and competitive products; and the risks, uncertainties and other factors discussed under the caption "Item 1A. Risk Factors" and elsewhere in the Company’s most recent Form 10-K and Form 10-Q filings with the Securities and Exchange Commission - which are available at www.sec.gov. As a result, you are cautioned not to place undue reliance on any forward-looking statements. Any forward-looking statements made in this press release speak only as of the date of this press release, and the Company undertakes no obligation to update such forward-looking statements, whether as a result of new information, future developments or otherwise.


Optinose Investor Contact
Jonathan Neely
jonathan.neely@optinose.com
267.521.0531

###










v3.25.1
Cover
Mar. 26, 2025
Cover [Abstract]  
Document Type 8-K
Document Period End Date Mar. 26, 2025
Entity Registrant Name OPTINOSE, INC.
Entity Incorporation, State or Country Code DE
Entity File Number 001-38241
Entity Tax Identification Number 42-1771610
Entity Address, Address Line One 777 Township Line Road
Entity Address, Address Line Two Suite 300
Entity Address, City or Town Yardley
Entity Address, State or Province PA
Entity Address, Postal Zip Code 19067
City Area Code 267
Local Phone Number 364-3500
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Entity Emerging Growth Company false
Title of 12(b) Security Common stock, par value $0.001 per share
Trading Symbol OPTN
Entity Central Index Key 0001494650
Amendment Flag false
OptiNose (NASDAQ:OPTN)
Historical Stock Chart
From Jun 2025 to Jul 2025 Click Here for more OptiNose Charts.
OptiNose (NASDAQ:OPTN)
Historical Stock Chart
From Jul 2024 to Jul 2025 Click Here for more OptiNose Charts.