UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
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CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): December 18, 2023
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OPTINOSE, INC.
(Exact Name of Registrant as Specified in its Charter)
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| Delaware | 001-38241 | 42-1771610 |
| (State or Other Jurisdiction of Incorporation or Organization) | (Commission File No.) | (I.R.S. Employer Identification No.) |
1020 Stony Hill 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)
Securities registered pursuant to Section 12(b) of the Act:
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| Title of each class | | Trading symbol(s) | | Name of each exchange on which registered |
| Common stock, par value $0.001 per share | | OPTN | | Nasdaq Global Select Market |
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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): | | | | | |
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| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-14(c)) |
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| 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). |
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| ☐ | Emerging growth company |
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| ☐ | 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. |
Item 1.01 Entry Into a Material Definitive Agreement
On December 18, 2023, OptiNose US, Inc. ("Optinose") entered into Amendment No. 1 (the "Amendment") to its Supply Agreement, dated July 1, 2017 (the "Supply Agreement") with Hovione Inter Ltd (“Hovione”). The Supply Agreement sets forth the terms and conditions pursuant to which Hovione manufactures and supplies fluticasone propionate, the active pharmaceutical ingredient included in XHANCE®, to Optinose. Pursuant to the Amendment, among other changes:
•the term of the Supply Agreement was extended to December 31, 2026;
•the annual volume tiers and associated pricing for fluticasone propionate quantities were modified, including the addition of an annual sourcing fee payable by Optinose; and
•Optinose may now also terminate the Supply Agreement without cause provided that it pays a specified termination fee.
The Supply Agreement, as amended, does not require Optinose to purchase any minimum quantity of fluticasone propionate.
The foregoing description of the Amendment does not purport to be complete and is qualified in its entirety by reference to the full text of the Amendment, a copy of which is attached to this Current Report on Form 8-K as Exhibit 10.1 and is incorporated herein by reference.
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.
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| | | OptiNose, Inc. |
| | By: /s/ Michael F. Marino |
| | | Michael F. Marino |
| | | Chief Legal Officer |
December 21, 2023
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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| Exhibit No. | | Description |
| 10.1* | | |
| 104 | | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
* Portions of this exhibit (indicated by asterisks "[**]") have been omitted in compliance with Item 601 of Regulation S-K.
