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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 17, 2025
| LIQUIDIA CORPORATION | ||
| (Exact name of registrant as specified in its charter) | ||
| Delaware | 001-39724 | 85-1710962 |
|
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
| 419 Davis Drive, Suite 100, Morrisville, North Carolina | 27560 | |
| (Address of principal executive offices) | (Zip Code) | |
Registrant’s telephone number, including area code: (919) 328-4400
| (Former name or former address, if changed since 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-4(c))
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
| Common stock | LQDA | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in 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. ¨
| Item 1.01 Entry into a Material Definitive Agreement. |
Sixth Amendment to Revenue Interest Financing Agreement
As previously disclosed, on January 9, 2023, Liquidia Technologies, Inc., a Delaware corporation (“Liquidia Technologies”) and a wholly owned subsidiary of Liquidia Corporation (the “Company”), entered into a Revenue Interest Financing Agreement with HealthCare Royalty Partners IV, L.P. (“HCR”), as amended by that certain First Amendment to Revenue Interest Financing Agreement, dated April 17, 2023, as amended by that certain Second Amendment to Revenue Interest Financing Agreement, dated June 28, 2023, as amended by that certain Third Amendment to Revenue Interest Financing Agreement, dated July 27, 2023, as amended by that certain Fourth Amendment to Revenue Interest Financing Agreement, dated January 3, 2024, and as further amended by that certain Fifth Amendment to Revenue Interest Financing Agreement, dated September 11, 2024 (as amended, the “Financing Agreement”).
On March 17, 2025 (the “Effective Date”), Liquidia Technologies and HCR entered into a Sixth Amendment to the Financing Agreement (the “Sixth Amendment”) to provide for up to an additional $100 million in financing. Pursuant to the Financing Agreement, HCR has funded an aggregate amount of $100 million prior to the Effective Date. Of the additional funds available under the Financing Agreement following the Sixth Amendment, HCR (x) funded $25.0 million on the Effective Date, (y) will fund $50.0 million after the first commercial sale of YUTREPIA following receipt of final FDA approval for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease, so long as no injunction has been issued prohibiting Liquidia from commercializing YUTREPIA for either or both of PAH and PH-ILD (“First Commercial Sale”), and (z) will fund $25.0 million upon mutual agreement of HCR and Liquidia Technologies if Liquidia Technologies achieves aggregate net sales of YUTREPIA in excess of $100 million at any time on or prior to June 30, 2026.
As consideration for the additional $25.0 million funded on the Effective Date, Liquidia Technologies has agreed to a fixed payment schedule that terminates in 2032. Payments on the last two tranches, when funded, would also follow a fixed payment schedule. As with the previously advanced funds, the aggregate payments to HCR are capped at 175% of the total amounts advanced by HCR, and there is potential for a true-up payment to be made by Liquidia Technologies if HCR’s internal rate of return is less than a minimum rate of return on the date the cap is reached. The minimum rate of return was 18% for the initial $67.5 million that was funded under the Financing Agreement and 16% for the remaining $32.5 million that was funded prior to the Sixth Amendment. With respect to the additional funds available under the Financing Agreement following the Sixth Amendment, the minimum rates of return will be (i) 16% for the $25 million funded on the Effective Date, (ii) 13% for the $50.0 million which may be funded upon the First Commercial Sale of YUTREPIA and (iii) 12% for the $25.0 million which may be funded upon the mutual agreement of Liquidia Technologies and HCR if Liquidia Technologies achieves aggregate net sales of YUTREPIA in excess of $100 million at any time on or prior to June 30, 2026.
A copy of the Sixth Amendment will be filed as an exhibit to the Company’s annual report on Form 10-K for the year ended December 31, 2024. The foregoing description of the Sixth Amendment does not purport to be complete and are qualified in their entirety by reference to such exhibits. The provisions of the Sixth Amendment, including the representations and warranties contained therein, are not for the benefit of any party other than the parties to such agreement and are not intended as a document for investors and the public to obtain factual information about the current state of affairs of the Company. Rather, investors and the public should look to other disclosures contained in the Company’s filings with the U.S. Securities and Exchange Commission.
| Item 8.01 Other Events. |
On March 18, 2025, the Company issued a press release announcing the execution of the Sixth Amendment by and between Liquidia Technologies and HCR. A copy of the press release is filed as Exhibit 99.1 hereto and is incorporated by reference into this Item 8.01.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. |
Exhibit | |
| 99.1 | Press Release of Liquidia Corporation, dated March 18, 2025. | |
| 104 | Cover Page Interactive Data File (the cover page tags are 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.
| March 18, 2025 | Liquidia Corporation | |
| By: | /s/ Michael Kaseta | |
| Name: Michael Kaseta | ||
| Title: Chief Financial Officer and Chief Operating Officer | ||
Exhibit 99.1
Liquidia Corporation Strengthens Financial Position by Amending HealthCare Royalty Agreement to Incrementally Add Up to $100 Million
MORRISVILLE, N.C., March 18, 2025 – Liquidia Corporation (NASDAQ: LQDA), a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease, today announced that it has entered into a sixth amendment to its agreement with HealthCare Royalty (“HCRx”) to provide for up to an additional $100 million of financing in three tranches (the “Sixth Amendment”), subject to certain closing conditions including the funding conditions discussed below. Liquidia intends to use the proceeds to fund ongoing commercial development of YUTREPIA™ (treprostinil) inhalation powder for the potential treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), continued development of YUTREPIA in other clinical trials, including but not limited to trials for pediatric patients and trials further evaluating the use of YUTREPIA in WHO Group 1 and WHO Group 3 patients, clinical development of L606 and for general corporate purposes.
Under the terms of the Sixth Amendment, Liquidia will receive $25.0 million at closing with the potential to receive two additional tranches of funding: $50.0 million upon the first commercial sale of YUTREPIA following receipt of final FDA approval for the treatment of PAH and PH-ILD, so long as no injunction has been issued prohibiting Liquidia from commercializing YUTREPIA for either or both of PAH and PH-ILD, and $25.0 million upon the mutual agreement of the parties after achieving aggregate net sales of YUTREPIA in excess of $100 million at any time on or prior to June 30, 2026.
Michael Kaseta, Liquidia’s Chief Financial Officer and Chief Operating Officer, said: “We appreciate the trust and commitment demonstrated by HCRx during the past several years. We are optimistic that the combination of the proceeds resulting from the Sixth Amendment, and a successful launch of YUTREPIA following the expiration of regulatory exclusivity in May 2025, could lead to Liquidia reaching profitability without the need for additional capital.”
Clarke Futch, Chairman and Chief Executive Officer of HCRx added: “We continue to look forward to Liquidia’s potential receipt of final FDA approval of YUTREPIA. We strongly believe in YUTREPIA’s ability to address unmet medical needs in patients with PAH and PH-ILD, and we are eager for patients to have access to a new therapeutic option that has demonstrated great clinical promise.”
As consideration for the additional $25.0 million funded at closing, Liquidia has agreed to a fixed payment schedule that terminates in 2032. Payments on the last two tranches, when funded, would also follow a fixed payment schedule. The aggregate payments to HCRx are capped at 175% of the total amounts advanced by HCRx, but also include a potential true-up payment to be made by Liquidia if HCRx’s internal rate of return is less than a minimum rate of return on the date the cap is reached. The minimum rates of return for the three new tranches are 16%, 13% and 12%, respectively.
About Liquidia
Corporation
Liquidia Corporation is a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease.
The company’s current focus spans the development and commercialization of products in pulmonary hypertension and other applications
of its proprietary PRINT® Technology. PRINT enabled the creation of Liquidia’s lead candidate, YUTREPIA™
(treprostinil) inhalation powder, an investigational drug for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension
associated with interstitial lung disease (PH-ILD). The company is also developing L606, an investigational sustained-release formulation
of treprostinil administered twice-daily with a next-generation nebulizer, and currently markets generic Treprostinil Injection for the
treatment of PAH. To learn more about Liquidia, please visit www.liquidia.com.
About
HealthCare Royalty
HealthCare Royalty is a leading royalty acquisition company focused on commercial or near-commercial biopharmaceutical products. With
offices in Stamford, Conn., San Francisco, Boston and London, HCRx has invested $5+ billion in over 85 biopharmaceutical products since
inception. For more information, visit https://www.hcrx.com. HEALTHCARE ROYALTY® and HCRx® are
registered trademarks of HealthCare Royalty Management, LLC.
Cautionary
Statements Regarding Forward-Looking Statements
This press release may include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
All statements contained in this press release other than statements of historical facts, including statements regarding our future results
of operations and financial position, our strategic and financial initiatives, our business strategy and plans and our objectives for
future operations, are forward-looking statements. Such forward-looking statements, including statements regarding clinical trials, clinical
studies and other clinical work (including the funding therefor, anticipated patient enrollment, safety data, study data, trial outcomes,
timing or associated costs), regulatory applications and related submission contents and timelines, including the potential for final
FDA approval of the NDA for YUTREPIA, which may occur after the expiration of the exclusivity period of TYVASO DPI, if at all, the timelines
or outcomes related to patent litigation with United Therapeutics in the U.S. District Court for the District of Delaware, litigation
with United Therapeutics and FDA in the U.S. District Court for the District of Columbia or other litigation instituted by United Therapeutics
or others, including rehearings or appeals of decisions in any such proceedings, the issuance of patents by the USPTO and our ability
to execute on our strategic or financial initiatives, the potential for future advances by HCRx, our anticipated use of net proceeds funded
under the agreement with HealthCare Royalty, our estimates regarding future expenses, capital requirements and needs for additional financing, and potential
revenue and profitability of YUTREPIA, if approved, involve significant risks and uncertainties and actual results could differ materially
from those expressed or implied herein. The favorable decisions of courts or other tribunals are not determinative of the outcome of the
appeals or rehearings of the decisions. The words “anticipate,” “believe,” “contemplate,” “continue,”
“could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,”
“potential,” “predict,” “project,” “should,” “target,” “would,”
and similar expressions are intended to identify forward-looking statements. We have based these forward-looking statements largely on
our current expectations and projections about future events and financial trends that we believe may affect our financial condition,
results of operations, business strategy, short-term and long-term business operations and objectives and financial needs. These forward-looking
statements are subject to a number of risks discussed in our filings with the SEC, as well as a number of uncertainties and assumptions.
Moreover, we operate in a very competitive and rapidly changing environment and our industry has inherent risks. New risks emerge from
time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business
or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any
forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the future events discussed in this press
release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking
statements. Nothing in this press release should be regarded as a representation by any person that these goals will be achieved, and
we undertake no duty to update our goals or to update or alter any forward-looking statements, whether as a result of new information,
future events or otherwise.
Contact Information
Investors:
Jason Adair
Chief Business Officer
919.328.4350
Jason.adair@liquidia.com
Media:
Patrick Wallace
Director, Corporate Communications
919.328.4383
patrick.wallace@liquidia.com