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Esperion (ESPR) Aims to Expand Key Drug Labels for Growth
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Esperion (ESPR - Free Report) has had a good run so far in 2023 and is progressing well with robust sale of its approved non-statin drugs, Nexletol and Nexlizet, in recent quarters.
The company has two FDA-approved drugs — Nexletol (bempedoic acid) and Nexlizet (bempedoic acid and ezetimibe) — in its commercial portfoliothat are approved for treating elevated LDL-C (bad cholesterol). These two oral drugs are marketed as Nilemdo and Nustendi in Europe and several other ex-U.S. markets in partnership with Daiichi Sankyo Europe (DSE).
The drugs’ new prescription demand has risen sequentially in the recent quarters, resulting in a strong performance. Product revenues, solely from the United States, totaled $37.3 million in the first half of 2023, indicating year-over-year growth of 39%.
The company is actively pursuing label expansion of its non-statin drugs, Nexletol and Nexlizet. In June, Esperion submitted regulatory applications in Europe and the United States, seeking approval for the use of both drugs in reducing cardiovascular risk among patients with or at high risk for atherosclerotic cardiovascular disease (ASCVD).
The regulatory filings are based on positive data from the phase III CLEAR study, which evaluated the efficiency of bempedoic acid in reducing cardiovascular (CV) risk. Data from the study showed that bempedoic acid led to CV risk reductions and significantly reduced the possibility of heart attack and coronary revascularization compared with a placebo.
Based on these results, Esperion is eligible to receive milestone payments from DSE. Per the terms of agreement with DSE, Esperion is eligible to receive a milestone payment of up to $300 million, depending on the magnitude of risk reduction in CV. However, when management communicated these results to DSE, it conveyed disagreement with the company’s assessment that the CLEAR study would support milestone payments. Esperion strongly disagrees with DSE in this regard and due to a difference in opinion, it expects a delay in the receipt of the milestone payment.
Shares of Esperion have nosedived 77.8% year to date compared with the industry’s 4.6% decline.
Image Source: Zacks Investment Research
If the new indications get approved by the regulatory agency, DSE will continue to market the drugs in Europe. DSE may also get commercialization rights of the drugs in several other countries going forward, per the new agreement. To date, the company has received $330 million in upfront and milestone payments.
The cholesterol management market represents a significant opportunity for ESPR. It is estimated that more than 18 million diagnosed patients in the United States on maximally tolerated statin therapy are unable to reach their LDL-C goal on this therapy alone. Bempedoic acid (found in Nexletol and Nexlizet) is the first therapy beyond statins to have demonstrated effective reduction of LDL-C levels and hard ischemic events in CV patients. It will not only benefit ASCVD patients but also primary prevention patients with limited treatment options at disposal.
In the past 90 days, the Zacks Consensus Estimate forANI Pharmaceuticals has gone up from $3.31 per share to $3.73 for 2023. The bottom-line estimate has gone up from $4.32 to $4.35 for 2024 during the same time frame. Shares of the company have rallied 58.6% year to date.
ANIP’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise 91.56%.
In the past 90 days, the Zacks Consensus Estimate for Annovis Bio has narrowed from a loss of $4.89 per share to a loss of $4.38 for 2023. The bottom-line estimate has narrowed from a loss of $3.18 to $2.77 for 2024 during the same time frame. Shares of the company have lost 6.2% year to date.
ANVS’ earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 13.40%.
In the past 90 days, the Zacks Consensus Estimate for Corcept’s earnings has gone up from 62 cents per share to 78 cents for 2023. The bottom-line estimate has also improved from 61 cents to 83 cents for 2024 during the same time frame. Shares of the company have rallied 56.2% year to date.
CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%.
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Esperion (ESPR) Aims to Expand Key Drug Labels for Growth
Esperion (ESPR - Free Report) has had a good run so far in 2023 and is progressing well with robust sale of its approved non-statin drugs, Nexletol and Nexlizet, in recent quarters.
The company has two FDA-approved drugs — Nexletol (bempedoic acid) and Nexlizet (bempedoic acid and ezetimibe) — in its commercial portfoliothat are approved for treating elevated LDL-C (bad cholesterol). These two oral drugs are marketed as Nilemdo and Nustendi in Europe and several other ex-U.S. markets in partnership with Daiichi Sankyo Europe (DSE).
The drugs’ new prescription demand has risen sequentially in the recent quarters, resulting in a strong performance. Product revenues, solely from the United States, totaled $37.3 million in the first half of 2023, indicating year-over-year growth of 39%.
The company is actively pursuing label expansion of its non-statin drugs, Nexletol and Nexlizet. In June, Esperion submitted regulatory applications in Europe and the United States, seeking approval for the use of both drugs in reducing cardiovascular risk among patients with or at high risk for atherosclerotic cardiovascular disease (ASCVD).
The regulatory filings are based on positive data from the phase III CLEAR study, which evaluated the efficiency of bempedoic acid in reducing cardiovascular (CV) risk. Data from the study showed that bempedoic acid led to CV risk reductions and significantly reduced the possibility of heart attack and coronary revascularization compared with a placebo.
Based on these results, Esperion is eligible to receive milestone payments from DSE. Per the terms of agreement with DSE, Esperion is eligible to receive a milestone payment of up to $300 million, depending on the magnitude of risk reduction in CV. However, when management communicated these results to DSE, it conveyed disagreement with the company’s assessment that the CLEAR study would support milestone payments. Esperion strongly disagrees with DSE in this regard and due to a difference in opinion, it expects a delay in the receipt of the milestone payment.
Shares of Esperion have nosedived 77.8% year to date compared with the industry’s 4.6% decline.
Image Source: Zacks Investment Research
If the new indications get approved by the regulatory agency, DSE will continue to market the drugs in Europe. DSE may also get commercialization rights of the drugs in several other countries going forward, per the new agreement. To date, the company has received $330 million in upfront and milestone payments.
The cholesterol management market represents a significant opportunity for ESPR. It is estimated that more than 18 million diagnosed patients in the United States on maximally tolerated statin therapy are unable to reach their LDL-C goal on this therapy alone. Bempedoic acid (found in Nexletol and Nexlizet) is the first therapy beyond statins to have demonstrated effective reduction of LDL-C levels and hard ischemic events in CV patients. It will not only benefit ASCVD patients but also primary prevention patients with limited treatment options at disposal.
Esperion Therapeutics, Inc. Price and Consensus
Esperion Therapeutics, Inc. price-consensus-chart | Esperion Therapeutics, Inc. Quote
Zacks Rank & Stocks to Consider
Esperion currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the same industry are ANI Pharmaceuticals (ANIP - Free Report) , Annovis Bio (ANVS - Free Report) and Corcept Therapeutics (CORT - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the Zacks Consensus Estimate forANI Pharmaceuticals has gone up from $3.31 per share to $3.73 for 2023. The bottom-line estimate has gone up from $4.32 to $4.35 for 2024 during the same time frame. Shares of the company have rallied 58.6% year to date.
ANIP’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise 91.56%.
In the past 90 days, the Zacks Consensus Estimate for Annovis Bio has narrowed from a loss of $4.89 per share to a loss of $4.38 for 2023. The bottom-line estimate has narrowed from a loss of $3.18 to $2.77 for 2024 during the same time frame. Shares of the company have lost 6.2% year to date.
ANVS’ earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 13.40%.
In the past 90 days, the Zacks Consensus Estimate for Corcept’s earnings has gone up from 62 cents per share to 78 cents for 2023. The bottom-line estimate has also improved from 61 cents to 83 cents for 2024 during the same time frame. Shares of the company have rallied 56.2% year to date.
CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%.