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BofA Securities has made an adjustment to the price target for Liquidia Technologies (NASDAQ: NASDAQ:LQDA), bringing it down to $23.00 from the previous $24.00, while still holding a Buy rating on the stock.
The new price target comes as a response to the latest update from the U.S. Food and Drug Administration (FDA) that the final approval for Yutrepia is expected around mid-2025, which is a shift from the earlier anticipated fourth quarter of 2024.
The management team at Liquidia Technologies is set to contest the FDA's unexpected decision to extend additional regulatory exclusivity to the reference brand, Tyvaso DPI, a move that has contributed to the delay in Yutrepia's approval. The core of the dispute appears to revolve around whether the data supporting Tyvaso DPI qualifies for a three-year new dosage form exclusivity.
The uncertainty surrounding the duration of the FDA dispute process, which could potentially be longer than the nine months initially projected for approval, has led BofA Securities to revise its expectations. The firm has expressed that more updates are needed regarding the dispute process before they can refine their view on the approval timeline.
In other recent news, United Therapeutics (NASDAQ:UTHR) received a boost as Goldman Sachs retained a neutral rating on the company, acknowledging the FDA's decision to grant their product Tyvaso a three-year exclusivity period. This move delays the market entry of a competing product, Yutrepia, from Liquidia Technologies until at least May 2025. In parallel, Liquidia Technologies experienced a price target reduction by both Jefferies and BTIG, following the FDA's decision favoring Tyvaso.
Despite setbacks, Liquidia continues with its planned activities, including the ASCENT and Phase 3 L606 studies. Interestingly, the FDA has granted Liquidia's Yutrepia tentative approval for treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). Liquidia also presented at the PHA 2024 International PH Conference, showcasing their investigational products for treating PAH.
On the financial front, United Therapeutics showed robust portfolio performance, and its Accelerated Share Repurchase (ASR) program reflects a strategic approach to capital allocation. However, Liquidia reported a decrease in revenue to $3.7 million in Q2 2024, down from $4.8 million in the same quarter of the previous year. Despite this, the company maintains a comfortable cash reserve of $133 million.
InvestingPro Insights
The recent adjustment of Liquidia Technologies' (NASDAQ:LQDA) price target by BofA Securities is a significant move that aligns with some of the challenges highlighted in the InvestingPro Tips. Analysts have recently revised their earnings downwards for the upcoming period, and they do not anticipate the company to be profitable this year. This is corroborated by the fact that Liquidia Technologies has not been profitable over the last twelve months. Additionally, the stock has experienced a substantial hit over the past week, signaling potential volatility and investor concern.
InvestingPro Data further reveals the financial landscape of Liquidia Technologies. The company has a market capitalization of $751.81 million and is trading at a high Price / Book multiple of 11.99 as of the last twelve months leading up to Q2 2024. Despite a strong gross profit margin of 69.52%, the company's revenue has decreased by 16.65% during the same period. Moreover, the stock's performance has been rocky, with a 26.34% decrease in the 1-week total return, although it has seen a 40.66% increase in the 1-year total return.
The InvestingPro platform offers additional insights, with a total of 10 InvestingPro Tips available for Liquidia Technologies, which can provide investors with a deeper analysis of the company's financial health and market position. For those looking to understand the full scope of Liquidia Technologies' potential and risks, these tips can be found at https://www.investing.com/pro/LQDA.
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