Release Date: March 04, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Esperion Therapeutics Inc (ESPR, Financial) received US FDA approval for expanded labels for NEXLETOL and NEXLIZET, making them the only FDA-approved non-statins to lower LDL-cholesterol and reduce the risk of myocardial infarction and coronary revascularization.
- The company achieved 12% sequential quarterly growth in total retail prescription equivalents (TRPEs) in Q4 2024, with expanded payer access covering over 173 million lives in the US.
- Esperion Therapeutics Inc (ESPR) has entered into international partnerships, including with CSL Seqirus in Australia and New Zealand, and Neopharm Israel, which are expected to drive future revenue growth.
- The company reported a 114% increase in total revenue for Q4 2024 compared to the same period in 2023, with significant growth in both US net product revenue and collaboration revenue.
- Esperion Therapeutics Inc (ESPR) has a strong financial position with cash and cash equivalents of $144.8 million as of December 31, 2024, and expects to finish 2025 with an even stronger cash position.
Negative Points
- The company faces risks and uncertainties associated with forward-looking statements, as highlighted under the Safe Harbor provision.
- Esperion Therapeutics Inc (ESPR) experienced an exceptional impact from the Medicare coverage gap in Q4 2024, affecting revenue alignment with TRPE growth.
- Research and development expenses decreased by 38% in Q4 2024 compared to the same period in 2023, primarily due to the completion of the CLEAR Outcomes study, indicating potential challenges in sustaining R&D momentum.
- Selling, general, and administrative expenses decreased by 19% in Q4 2024 compared to the same period in 2023, primarily due to onetime legal expenses, which may not be sustainable in the long term.
- Esperion Therapeutics Inc (ESPR) is still in the process of evaluating potential in-licensing or acquisition opportunities, which may delay portfolio expansion and pipeline advancement.
Q & A Highlights
Q: Have you agreed with the FDA on the regulatory path for the triple combination in the US, and will it require a cardiovascular outcomes trial (CVOT)?
A: Sheldon Koenig, President and CEO: We are not providing additional details on our discussions with the FDA at this time, but we will share more in the fall. The triple combination does not require a CVOT or any heavy clinical studies. Ben Halladay, CFO, added that this is an important step in the life cycle management of bempedoic acid and could potentially extend our patent life.
Q: Is it reasonable to expect that US bempedoic acid revenue growth will accelerate in 2025 due to improved access and changes in Medicare Part D?
A: Benjamin Halladay, CFO: We expect to see significant growth similar to past trends. The smoothing out of gross-to-net factors should lead to a more direct translation of prescription growth to revenue growth, especially in the second half of the year.
Q: How are you building efficiencies into the cost of goods sold (COGS) for US sales?
A: Benjamin Halladay, CFO: Our COGS have been consistent, with no change in price per tablet since early 2024. We are evaluating ways to reduce per tablet costs through cheaper suppliers, but this is a longer-term discussion. Once tech transfer is complete, we expect to see gross margin benefits.
Q: What feedback are you receiving from new prescribers, and what are the main reasons for not prescribing yet?
A: Eric Warren, Chief Commercial Officer: The efficacy and unique clinical profile of NEXLETOL and NEXLIZET are driving positive responses. The main opportunity is to educate prescribers about improved coverage. There is excitement in the field, and customers are responding well.
Q: Can you describe the level of maturity in your discussions for potential in-licensing?
A: Sheldon Koenig, President and CEO: We are conducting a landscape analysis and are far along in evaluating products that are late-stage or approved. We aim to leverage our infrastructure to add value and will continue to update on our progress.
Q: Are you and your European partner developing the triple combination concurrently, or is it separate?
A: Sheldon Koenig, President and CEO: Both Esperion and Daiichi Sankyo Europe are developing the triple combination. We are working together to maximize the product's potential and achieve blockbuster status.
Q: How familiar are prescribers with bempedoic acid, and do you expect awareness to increase soon?
A: Eric Warren, Chief Commercial Officer: Awareness is improving, with unaided awareness progressing and aided awareness at 95%. The team is effectively reaching healthcare providers, and the efficacy of our products is resonating well.
Q: Regarding the triple combination studies, are there any anecdotes about its use in combination, and have physicians shown interest in studying it?
A: Eric Warren, Chief Commercial Officer: There is significant utilization in combination with statins, especially lower doses of high-intensity statins. The triple combination offers a compelling value proposition with complementary mechanisms and proven cardiovascular outcomes.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
