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ESPR Settles Nexletol/Nexlizet Patent Litigation With RDY, Stock Up
ZACKS· 2025-10-06 14:56
Core Insights - Esperion Therapeutics (ESPR) has reached a settlement with Dr. Reddy's Laboratories (RDY) regarding patents for Nexletol and Nexlizet, preventing RDY from launching generic versions in the U.S. before April 19, 2040, under certain conditions [1][6] - Following the announcement, Esperion's shares increased by 13.8%, and the stock has risen 50% year-to-date, outperforming the industry growth of 14.1% [2] Patent and Litigation Summary - The settlement resolves patent litigation initiated by Esperion against RDY's abbreviated new drug application (ANDA) for generic versions of Nexletol and Nexlizet [2][5] - All disputes concerning the validity or infringement of U.S. Patent No. 7,335,799 have been resolved with this settlement [5][6] - Other patents involved in ongoing litigation are set to expire in March 2036 and June 2040 [7] Product Performance - Nexletol and Nexlizet are marketed as Nilemdo and Nustendi in international markets, with Esperion earning royalties from these sales [8] - In the first half of 2025, net product sales of Nexletol and Nexlizet in the U.S. grew by 42%, indicating strong prescription growth [9]
ESPR's Q1 Earnings Miss Estimates, Revenues Beat, Stock Down
ZACKS· 2025-05-07 17:10
Core Insights - Esperion Therapeutics reported a loss of 21 cents per share in Q1 2025, which was wider than the Zacks Consensus Estimate of a loss of 18 cents, compared to earnings of 34 cents per share in the same quarter last year [1] - Total revenues for Esperion in Q1 2025 were $65 million, reflecting a 53% year-over-year decline, primarily due to a one-time milestone payment received in Q1 2024; however, revenues exceeded the Zacks Consensus Estimate of $58 million [2] - The company's stock fell 7.1% on May 6 following the earnings announcement and has decreased 55.7% year-to-date, contrasting with a 0.4% decline in the industry [3] Financial Performance - Product revenues from the U.S. totaled $34.9 million in Q1 2025, up 41% year-over-year, driven by expanded label and commercial initiatives; this figure surpassed the Zacks Consensus Estimate of $29.8 million [5] - Collaboration revenues, including royalties and partner revenues, were $30.1 million, down almost 73% year-over-year, but beat the Zacks Consensus Estimate of $27.9 million [8] - Research and development expenses decreased by 6% to $12.6 million, while selling, general, and administrative expenses rose by 2% to $43 million due to increased marketing and consulting costs [8][9] Future Outlook - Esperion expects operating expenses for 2025 to be in the range of $215-$235 million, which includes $15 million in non-cash expenses related to stock compensation [10] - The company is developing two triple combination products with Nexletol/Nexlizet, expected to launch in 2027, which may offer LDL-C lowering of more than 60% [11] - Esperion is also planning to develop ESP-1336 for the treatment of primary sclerosing cholangitis (PSC), a market estimated to exceed $1 billion annually [12]