Liquidia Corporation Reports Full Year 2023 Financial Results and Provides Corporate Update
Liquidia Corporation (LQDA) reported financial results for 2023, preparing to launch YUTREPIA™ upon FDA approval. The Federal Circuit rejected United Therapeutics' request for rehearing on '793 Patent. The company aims to become a full-scale commercial entity in 2024. Financially, revenue increased to $17.5 million, but net loss rose to $78.5 million in 2023.
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Net loss increased to $78.5 million in 2023, compared to $41.0 million in 2022. Research and development expenses surged by 122% to $43.2 million in 2023. General and administrative expenses rose by 38% to $44.7 million in 2023. Total other expense, net increased to $5.1 million in 2023.
The financial results reported by Liquidia Corporation indicate a significant increase in research and development expenses, which have more than doubled from the previous year. This uptick is primarily attributed to the company's investment in the exclusive license for L606 and the advancement of their YUTREPIA program. While such investments are essential for long-term growth, they have also contributed to a substantial net loss for the year, widening from the prior year. It's notable that the company has secured additional funding through equity and non-dilutive capital, strengthening its cash position. This financial maneuvering suggests a strategic approach to funding their pipeline, which could be seen as a positive signal to investors looking for growth potential despite the short-term increase in net loss.
Liquidia's focus on advancing its inhaled treprostinil portfolio, particularly with YUTREPIA and L606, reflects a commitment to addressing pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The recent legal developments, including the invalidation of a competing patent and anticipation of final FDA approval, could significantly impact the market dynamics for PAH treatments. The proprietary PRINT Technology mentioned may offer a competitive advantage in terms of delivery and dosing, which is crucial in this therapeutic area. The potential for YUTREPIA to become a first-choice treatment could disrupt the market and create new revenue streams for Liquidia, pending successful commercialization and market adoption.
From a market perspective, the anticipation of YUTREPIA's launch following the expiration of Tyvaso's market exclusivity is a pivotal moment for Liquidia. The company's strategic positioning, including the expansion of its sales force, indicates readiness to capitalize on this opportunity. However, the market's response to a new entrant will depend on the product's perceived benefits over existing treatments, adoption by healthcare providers and successful navigation of pricing and reimbursement challenges. The interim data from the ASCENT study and the initiation of the global PH-ILD study will be critical in shaping the market's perception of YUTREPIA's efficacy and safety, potentially influencing its market share in the competitive landscape of PAH treatments.
03/13/2024 - 06:00 AM
Preparing to launch YUTREPIA™ (treprostinil) inhalation powder upon final FDA approval Federal Circuit rejected request by United Therapeutics for rehearing of earlier decision finding ‘793 Patent invalid Advancing industry leading portfolio for inhaled treprostinil with YUTREPIA and sustained-release program L606 Company to host webcast today at 8:30 a.m. ET MORRISVILLE, N.C., March 13, 2024 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA) (Liquidia or the Company) today reported financial results for the full year ended December 31, 2023. The Company will host a webcast at 8:30 a.m. ET to discuss the 2023 financial results and provide a corporate update.
Roger Jeffs, Liquidia’s Chief Executive Officer, said: “Based on our success last year, we are preparing to become a full-scale commercial entity in 2024 and initiate meaningful change to the lives of patients diagnosed with PAH and PH-ILD. Given recent favorable court decisions, we have positioned the Company to be ready for launch of YUTREPIA in both indications following the expiration of Tyvaso’s market exclusivity on March 31, 2024. Once on the market, we are confident that the medical community will see first-hand that YUTREPIA has the potential to not only be the best-in-class inhaled product, but also the prostacyclin of first choice given its convenient, low-effort delivery and wide dosing range enabled by our proprietary PRINT Technology.”
Corporate Updates
Invalidity of sole patent supporting injunction was affirmed in appeal proceedings at the Federal Circuit. In December 2023, the previous ruling by the Patent Trial and Appeal Board (PTAB) that all of the claims in U.S. Patent No. 10,716,793 (‘793 Patent) are invalid was affirmed by the U.S. Court of Appeals for the Federal Circuit (Federal Circuit). On March 12, 2024, the Federal Circuit rejected United Therapeutics’ request for a rehearing of the ruling in December. Liquidia has submitted these Federal Circuit rulings to Judge Andrews and requested that he set aside the injunction preventing final regulatory approval of YUTREPIA that he entered in 2022, which is based solely on the ‘793 Patent.
Awaiting final FDA approval of YUTREPIA to treat PAH and PH-ILD after March 31, 2024. In September 2023, the U.S. Food and Drug Administration (FDA) accepted for review the Company’s amendment to the tentatively approved new drug application (NDA) for YUTREPIA to include the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD) to the label. The FDA tentatively approved YUTREPIA to treat pulmonary arterial hypertension (PAH) in November 2021 and confirmed that the addition of the PH-ILD indication would not require any new clinical studies. The FDA may grant final approval of YUTREPIA for both PAH and PH-ILD after the new clinical investigation exclusivity granted to Tyvaso® expires on March 31, 2024 and after Judge Andrews sets aside his injunction.
Advancing industry leading portfolio for inhaled treprostinil between YUTREPIA and sustained-release program, L606. In December 2023, the Company opened enrollment in the ASCENT study, an open-label prospective multicenter study to evaluate safety and tolerability of YUTREPIA in patients diagnosed with PH-ILD. Liquidia plans to complete enrollment of all 60 patients in 2024 and will share interim data at upcoming conferences. Also in December 2023, the FDA confirmed that a single Phase 3 placebo-controlled efficacy trial in PH-ILD patients would be required to support approval of L606 for the treatment of both PAH and PH-ILD under the 505(b)(2) regulatory pathway. The Company is preparing to initiate the global PH-ILD study by the end of 2024. In addition, an on-going, open-label study of L606 in U.S. patients with PAH and PH-ILD is more than one-third enrolled and includes some patients who have been successfully treated with L606 for longer than one year and at doses comparable to 25 to 27 breaths of Tyvaso, four times daily.
Full Year 2023 Financial Results
Cash and cash equivalents totaled $83.7 million as of December 31, 2023. In the first week of January, Liquidia closed two transactions that brought an additional $100 million of gross proceeds into the Company. Liquidia and an affiliate of Patient Square Capital entered into a common stock purchase agreement for the private placement of common stock that yielded gross proceeds of approximately $75.0 million . That same week, HealthCare Royalty Partners (HCRx) and Liquidia entered a fourth amendment to the Revenue Interest Financing Agreement (RIFA) to fund an additional $25.0 million . HCRx has now invested $67.5 million in non-dilutive capital from the $100 million originally contemplated from four tranches under the RIFA.
Revenue was $17.5 million for the year ended December 31, 2023, compared with $15.9 million for the year ended December 31, 2022. Revenue related primarily to the sale of Treprostinil Injection under the Promotion Agreement with Sandoz Inc. The increase of $1.6 million was primarily due to favorable gross-to-net chargeback, rebate, and managed care adjustments offset by the impact of lower sales quantities as compared to the prior year.
Cost of revenue was $2.9 million for both the year ended December 31, 2023 and the year ended December 31, 2022. Cost of revenue related to the Promotion Agreement as noted above. During the fourth quarter of 2024 our sales force expanded in size, however, this increase was offset by a decrease in amortization.
Research and development expenses were $43.2 million for the year ended December 31, 2023 compared with $19.4 million for the year ended December 31, 2022. The increase of $23.8 million or 122% was driven largely by the $10.0 million upfront license fee payment to Pharmosa for the exclusive license in North America to develop and commercialize L606. We incurred an additional $2.6 million in expenses related to our L606 program during the year ended December 31, 2023. Expenses related to our YUTREPIA program increased by $6.3 million from $6.7 million during the year ended December 31, 2022 to $13.0 million during the year ended December 31, 2023 primarily due to increased manufacturing activities related to pre-launch commercial supply and the startup of our ASCENT study during 2023. Personnel and consulting expenses, including stock compensation expense, increased $5.1 million primarily due to increased headcount to support the potential commercialization of YUTREPIA.
General and administrative expenses were $44.7 million for the year ended December 31, 2023, compared with $32.4 million for the year ended December 31, 2022. The increase of $12.3 million or 38% was primarily due to a $9.8 million increase in personnel and consulting expenses, including stock-based compensation, and a $1.4 million increase in commercial expenses in preparation for the potential commercialization of YUTREPIA.
Total other expense, net was $5.1 million for the year ended December 31, 2023, compared with $2.2 million for the year ended December 31, 2022. The increase of $2.9 million was primarily due to a $3.9 million increase in interest expense attributable to the higher borrowings under the RIFA as compared to balances outstanding under the Amended and Restated Loan and Security Agreement with Silicon Valley Bank (A&R SVB LSA) and a $1.3 million increase in loss on extinguishment of debt due offset by a $2.4 million increase in interest income attributable to higher money market yields. The year ended December 31, 2023 included a $2.3 million loss on extinguishment of debt related to repayment of the A&R SVB LSA in January 2023. The year ended December 31, 2022 included a $1.0 million loss on extinguishment of debt related to the refinance of our long-term debt with SVB in January 2022.
Net loss for the year ended December 31, 2023 was $78.5 million , or $1.21 per basic and diluted share, as compared to a net loss of $41.0 million , or $0.67 per basic and diluted share, for the year ended December 31, 2022.
About YUTREPIA™(treprostinil) inhalation powder ® technology, which enables the development of drug particles that are precise and uniform in size, shape, and composition, and that are engineered for enhanced deposition in the lung following oral inhalation. Liquidia has completed INSPIRE, or Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil, an open-label, multi-center phase 3 clinical study of YUTREPIA in patients diagnosed with PAH who are naïve to inhaled treprostinil or who are transitioning from Tyvaso® (nebulized treprostinil). YUTREPIA was previously referred to as LIQ861 in investigational studies.
Tyvaso® is a registered trademark of United Therapeutics Corporation.
About L606 (liposomal treprostinil) inhalation suspension
About Treprostinil Injection ® (treprostinil) and is offered to patients and physicians with the same level of service and support, but at a lower price than the branded drug. Liquidia PAH promotes the appropriate use of Treprostinil Injection for the treatment of PAH in the United States in partnership with its commercial partner, who holds the Abbreviated New Drug Application (ANDA) with the FDA.
About pulmonary arterial hypertension (PAH)
About pulmonary hypertension associated with interstitial lung disease (PH-ILD)
About Liquidia Corporation ® Technology. The company operates through its two wholly owned subsidiaries, Liquidia Technologies, Inc. (Liquidia Technologies) and Liquidia PAH, LLC (Liquidia PAH). Liquidia Technologies has developed YUTREPIA™ (treprostinil) inhalation powder for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). Liquidia Technologies is also developing L606, an investigational liposomal formulation of treprostinil administered twice-daily with a short-duration next-generation nebulizer, for use in North America. Liquidia PAH provides for the commercialization of pharmaceutical products to treat pulmonary disease, such as generic Treprostinil Injection. For more information, please visit www.liquidia.com .
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, the timeline or outcome related to patent litigation in the U.S. District Court for the District of Delaware, inter partes review proceedings conducted at the PTAB 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, 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,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “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.
Company Contacts
Investors: jason.adair@liquidia.com
Media Inquiries:
Liquidia Corporation Select Balance Sheet Data
December 31, December 31, 2023 2022 Cash and cash equivalents $ 83,679 $ 93,283 Total assets $ 118,332 $ 129,198 Total liabilities $ 71,039 $ 38,776 Accumulated deficit $ (429,098 ) $ (350,596 ) Total stockholders’ equity $ 47,293 $ 90,422
Liquidia Corporation Consolidated Statements of Operations and Comprehensive Loss
Year Ended December 31, 2023 2022 Revenue $ 17,488 $ 15,935 Costs and expenses: Cost of revenue 2,888 2,859 Research and development 43,242 19,435 General and administrative 44,742 32,411 Total costs and expenses 90,872 54,705 Loss from operations (73,384 ) (38,770 ) Other income (expense): Interest income 3,466 1,090 Interest expense (6,273 ) (2,338 ) Loss on extinguishment of debt (2,311 ) (997 ) Total other income (expense), net (5,118 ) (2,245 ) Net loss and comprehensive loss $ (78,502 ) $ (41,015 ) Net loss per common share, basic and diluted $ (1.21 ) $ (0.67 ) Weighted average common shares outstanding, basic and diluted 64,993,476 60,958,862
The ticker symbol for Liquidia Corporation is LQDA.
The Federal Circuit rejected United Therapeutics' request for rehearing on the invalidity of the '793 Patent.
Liquidia Corporation reported revenue of $17.5 million for the year ended December 31, 2023.
The net loss for Liquidia Corporation was $78.5 million for the year ended December 31, 2023.
Research and development expenses surged by 122% to $43.2 million for Liquidia Corporation in 2023.
