d2c60169434ddfaf04cc8d9f17c35ffde180d5264946c877efe4a9f5f95ab751

bba4cc8f2d7a1f564919bfd5ca294981e0a83869b481c82fcbc381811b3da877

b2b33ff37c9b2dce9746c32f0cabbe22b9f45803680fac72b5550a005c295617

23794d91c53ae875c8e247d72561e35d9d06ee07c70c9e0dbcc977a6d161504a

Average Placebo-Corrected LDL-C Lowering (%)

Reduction in Major Cardiovascular Events (%)

cda6121baf5ebc1bae6eb92ba42ac5d54ef5c30a3fee2a52bda492848e3e954e

- NEXLETOL & NEXLIZET

- Collaboration Revenue

Total Revenue

71d3a5acc7899da555f636b1ff5b64649b830b57e9c39488bd5ffb0f09a64fcd

1. Can you provide more details on the gross-to-net headwinds you're experiencing due to the recent Medicare contracts, and how do you anticipate these will impact net pricing and profitability in the coming quarters?
2. With the expansion to over 165 million patient lives under the new utilization management criteria, have you had to make significant concessions or pricing adjustments to achieve this coverage, and do you expect further concessions to secure additional contracts?
3. Despite the reported double-digit growth in prescriptions, what challenges do you foresee in maintaining this momentum, especially considering potential headwinds such as the Medicare coverage gap and the upcoming IRA changes?
4. Given the 20% increase in selling, general and administrative expenses due to higher commercial headcount and promotional costs, how do you plan to manage SG&A expenses moving forward to ensure profitability if revenue growth does not meet expectations?
5. Could you elaborate on the expected financial contributions and timelines from your international partnerships, particularly with Otsuka in Japan, and how potential delays or challenges in these markets might affect your overall financial outlook?

774645dd29e54e51cd4385cde6cf479fcef128e2ca20912ea08c7e09f343ef15

Esperion Therapeutics, Inc. is a pharmaceutical company focused on developing and commercializing oral, once-daily, non-statin medicines for patients with elevated low-density lipoprotein cholesterol (LDL-C). The company aims to address unmet needs in the treatment of atherosclerotic cardiovascular disease (ASCVD) and heterozygous familial hypercholesterolemia (HeFH) through innovative therapies. Esperion sells medications such as NEXLETOL and NEXLIZET, which are designed to lower LDL-C levels in adults with primary hyperlipidemia.  **[0001628280-24-020862_espr-20240331.htm:7]** **[0001628280-23-037195_espr-20230930.htm:6]** **[0001628280-22-027479_espr-20220930.htm:33]** 

1. **Collaboration Revenue** - Generates income through agreements with international partners, including product sales and royalties.  **[0001628280-24-020841_q12024earningspressrelease.htm:5]** **[0001628280-24-036597_q22024earningsrelease.htm:5]** 
2. **Product Sales** - Sells medications like NEXLETOL and NEXLIZET, which are used to lower LDL-C in adults with primary hyperlipidemia.  **[0001628280-24-020841_q12024earningspressrelease.htm:5]** **[0001628280-24-036597_q22024earningsrelease.htm:5]**

f4f3cce4eb2ffdc72d86ee42dd5b23f6b677612adfdfbd99c90b2db4e06e39b6

Product Sales

Collaboration Revenue

d097e6e9829e053d66ff3015f8b94482f790d9fec1e9e289598b886349fca563

| **Earnings Call Title** | **Issued Period** | **Guided Period** | **Guidance** |
|--------------------------|-------------------|-------------------|--------------|
| **Q3 2024 Earnings Call** | Q3 2024 | FY 2024 | - **Total Operating Expenses (OpEx)**: Expected to be **$225 million to $245 million**, including **$20 million in noncash expenses related to stock compensation**. **[ESPR_3406499_5]** |
| **Q2 2024 Earnings Call** | Q2 2024 | FY 2024 | - **Total Operating Expenses (OpEx)**: Expected to be **$225 million to $245 million**, including **$20 million in noncash expenses related to stock compensation**. **[ESPR_3398368_6]** - **Tech Transfer with DSE**: Completion expected by **2025**. **[ESPR_3398368_5]** - **New Drug Applications**: Planned filings in **Canada, Australia, and Israel** by the end of **2024**. **[ESPR_3398368_3]** - **Otsuka NDA in Japan**: Filing expected in **H2 2024**, with approval and pricing anticipated in **2025**. **[ESPR_3398368_3]** |
| **Q1 2024 Earnings Call** | Q1 2024 | FY 2024 | - **R&D Expense**: Expected to be **$45 million to $55 million**. **[ESPR_3386772_3]** - **SG&A Expense**: Expected to be **$180 million to $190 million**. **[ESPR_3386772_3]** - **Total Operating Expenses (OpEx)**: Expected to be **$225 million to $245 million**. **[ESPR_3386772_3]** |
| **Q4 2023 Earnings Call** | Q4 2023 | FY 2024 | - **R&D Expense**: Expected to be **$45 million to $55 million**. **[ESPR_3375184_5]** - **SG&A Expense**: Expected to be **$180 million to $190 million**. **[ESPR_3375184_5]** - **Total Operating Expenses (OpEx)**: Expected to be **$225 million to $245 million**. **[ESPR_3375184_5]** |

370ff6bf62684df27338e5135ba180c3f1c63b845a4ef98b7e64f162a37cd088

| Name              | Position                   | Start Date | Short Bio                                                                                                                                                                                                                                                                                                                                 |
|-------------------|----------------------------|------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sheldon L. Koenig | President and CEO          | May 2021   | Sheldon L. Koenig has served as the **President and Chief Executive Officer** of Esperion Therapeutics, Inc. since **May 2021**. He was also appointed to the company's Board of Directors in the same month. Prior to this role, he served as Esperion's Chief Operating Officer starting in **December 2020**.  **[0001628280-24-015824_esperion-definitive2023pro.htm:13]**                                                         |
| JoAnne Foody      | Chief Medical Officer      | June 2021  | JoAnne Foody, M.D., FACC, FAHA, has served as the **Chief Medical Officer** of Esperion Therapeutics since **June 2021**. Prior to joining Esperion, she held roles of increasing responsibility at Johnson & Johnson's Janssen Pharmaceutical Company from **November 2016 to June 2021**.  **[0001628280-24-015824_esperion-definitive2023pro.htm:16]** **[0001628280-23-011506_esperion-definitive2022pro.htm:15]** **[0001628280-22-009197_esperion-definitive2021pro.htm:15]**                                                                           |
| Benjamin Halladay | Chief Financial Officer    | Nov 2022   | Benjamin Halladay has served as the **Chief Financial Officer** of Esperion Therapeutics, Inc. since **November 2022**. He joined the company in **January 2020**, holding various roles including Senior Director of Financial Planning and Analysis (from **August 2022** to November 2022).  **[0001628280-24-015824_esperion-definitive2023pro.htm:16]** **[0001628280-23-011506_esperion-definitive2022pro.htm:15]**                                                                           |
| Benjamin Looker   | General Counsel            | Jan 2022   | Benjamin Looker has served as the **General Counsel** of Esperion Therapeutics, Inc. since **January 1, 2022**. Prior to joining Esperion, he was the General Counsel of Trillium Therapeutics from April 2021 until its acquisition by Pfizer Inc. in November 2021.  **[0001628280-24-015824_esperion-definitive2023pro.htm:17]** **[0001628280-22-000142_espr-20220104.htm:1]** **[0001628280-22-000142_ex991generalcounselhirepre.htm:0]**                                                                                                  |
| Eric Warren       | Chief Commercial Officer   | Mar 2022   | Eric Warren has served as the **Chief Commercial Officer** of Esperion Therapeutics since **March 2022**. Prior to this role, he was the company's **Vice President, US Sales and Marketing** from **January 2021 to March 2022**.  **[0001628280-24-015824_esperion-definitive2023pro.htm:17]** **[0001628280-23-011506_esperion-definitive2022pro.htm:15]** **[0001628280-23-010392_esperion-preliminary2022pr.htm:15]**                                                                                                                                     |

56db9282740d793d9495bde5668dc42d083969de2d1833a6bdd755bf7acf6ff5

1. **Medicare Coverage Expansion**  
   **Q:** Has Medicare coverage improved, and will it expand further?  
   **A:** The Medicare coverage for our products has increased from **28% at launch to over 65% now**.  **[ESPR_3406499_8]**  This improvement is effective immediately due to payers accelerating their processes, rather than waiting until 2025 or 2026.  **[ESPR_3406499_8]**  We anticipate additional Medicare contracts, positioning us to cover **90% of U.S. national lives** with our coverage.  **[ESPR_3406499_8]**  This expanded coverage is making it easier for physicians to prescribe and patients to access our products.

2. **Sales Growth and Q4 Outlook**  
   **Q:** What's driving prescription growth, and will Q4 revenue surpass Q3?  
   **A:** We experienced **double-digit growth** on all metrics in Q3, and Q4 has started off very strong.  **[ESPR_3406499_7]**  The growth is driven by improved access, with physicians now finding it easier to prescribe our products due to better coverage and reduced prior authorization requirements.  **[ESPR_3406499_7]**  We are very confident that Q4 will be even better than Q3.  **[ESPR_3406499_7]** 

3. **Removal of Prescription Barriers**  
   **Q:** Are there changes in payer dynamics impacting prescriptions?  
   **A:** Yes, the step edit through ezetimibe has been removed in both commercial and Medicare contracts.  **[ESPR_3406499_10]**  In two large accounts, **SilverScript's Caremark and Aetna**, there is **no prior authorization required**.  **[ESPR_3406499_10]**  This means getting our products has become easier for both physicians and patients, without us having to give any concessions for these changes.  **[ESPR_3406499_10]** 

4. **Market Share Gains**  
   **Q:** How is product use changing relative to PCSK9 inhibitors?  
   **A:** With increased momentum, we are seeing a shift from treating only ASCVD patients to also including primary prevention patients and those intolerant to statins.  **[ESPR_3406499_8]**  Ezetimibe is starting to lose share, and we've observed about a **one-point decrease** in new-to-brand share for PCSK9 inhibitors since our label change.  **[ESPR_3406499_8]** 

5. **Otsuka Collaboration Milestones**  
   **Q:** What are the milestone payments from the Otsuka collaboration?  
   **A:** The milestones include the filing and approval of the Japanese New Drug Application (JNDA), a milestone based on inclusion in the U.S. label payable once approved, and a pricing milestone.  **[ESPR_3406499_9]**  These payments are expected to occur by the **end of 2025**  **[ESPR_3406499_9]** , providing a significant royalty stream from Japan, one of the largest lipid markets in the world.  **[ESPR_3406499_12]** 

6. **Net Price Outlook**  
   **Q:** Is the net price expected to be stable going forward?  
   **A:** We anticipate continued standard Q4 cyclicality due to the Medicare coverage gap this year.  **[ESPR_3406499_11]**  However, with the Inflation Reduction Act (IRA), we expect a smoothing out of the gross-to-net over the course of the year.  **[ESPR_3406499_11]**  While there may not be a major change overall, the seasonality from Q1 to Q4 may diminish, resulting in more predictable and streamlined revenue.  **[ESPR_3406499_11]** 

7. **Market Dynamics in Japan**  
   **Q:** What are the expectations for the Japanese market?  
   **A:** Our partner, Otsuka, has completed a Phase III clinical trial showing statistical significance and is in the process of filing with Japanese healthcare authorities.  **[ESPR_3406499_12]**  Japan is one of the largest lipid markets globally, and we are on track with high expectations from Otsuka.  **[ESPR_3406499_12]**  This will benefit us with a significant royalty stream.  **[ESPR_3406499_12]** 

8. **Patient Copays and Preferred Status**  
   **Q:** What's the average copay for Medicare vs. commercial patients?  
   **A:** For Medicare patients, now that we're preferred, the average out-of-pocket cost has reduced to **$45**, down from $150–$200 previously.  **[ESPR_3406499_13]**  For commercial patients using our copay card, the copay is approximately **$25**.  **[ESPR_3406499_13]**  These changes make our products more accessible and affordable to patients.

4150c7bf7985d897365e7f1ebea81873b5595de061d9ef0bc8dc47f384e00466

- The recent FDA approval of broad new labels for NEXLETOL and NEXLIZET expands the addressable patient population to approximately **70 million** in the U.S., with the company focusing on **30 million** patients who are actively engaged in therapy, representing a significant market opportunity for growth.  **[ESPR_3386772_9]**
- Positive initial momentum following the label update, including strong enthusiasm from both primary care physicians and cardiologists, early week-over-week prescription growth, and increased consumer awareness through targeted campaigns (e.g., the **"Lipid Lurkers"** campaign with over **1.6 million** exposures), suggests a significant acceleration in product growth in upcoming quarters.  **[ESPR_3386772_5]** **[ESPR_3386772_10]** **[ESPR_3386772_13]**
- Favorable payer interactions, with utilization management criteria being updated to include primary prevention patients and ease statin requirements, as well as improving Medicare coverage (coverage now close to **50%**), expanding access to the drug without significant additional concessions, which could lead to increased sales and maintain margins.  **[ESPR_3386772_7]** **[ESPR_3386772_14]** **[ESPR_3386772_11]**

58bb26baf9551319b9c0d9274e62b4d716c0f810b4403cd98c31f0982d4d7c50

- Despite positive initial growth, **bempedoic acid's uptake may take longer to ramp up** as cardiovascular launches require more time compared to other indications, potentially delaying expected revenues.  **[ESPR_3398368_10]**
- **Physician confidence in prescribing NEXLETOL and NEXLIZET is still building**, indicating that additional efforts are needed to reach and convince physicians, which may slow market penetration.  **[ESPR_3398368_8]**
- **Medicare coverage is currently only around 50%**, and while efforts are being made to increase this, the limited coverage may restrict patient access and hinder prescription growth in a significant market segment.  **[ESPR_3398368_9]**

5a4651b5326fe63e5e672e3f1c1284ad6b50bfd6747c44020901c12e4d747175

- **Esperion anticipates FDA approval of its new label by March 31**, which is expected to **expand the addressable market from 10 million to over 30 million patients**, including both **primary and secondary prevention patients**, serving as a major growth catalyst.  **[ESPR_3375184_11]** **[ESPR_3375184_8]** **[ESPR_3375184_10]**
- **Positive interactions with the FDA** and **payers already making changes in anticipation of the new label**, along with **ICER's determination that NEXLIZET is cost-effective and should be on all formularies**, suggest improved payer coverage and reimbursement, facilitating wider adoption.  **[ESPR_3375184_8]** **[ESPR_3375184_10]**
- **Esperion's products are uniquely differentiated** as the only drugs besides statins studied in both secondary and primary prevention, offering physicians more choices and potentially driving substantial demand once the new label allows promotion of the **CLEAR Outcomes data**.  **[ESPR_3375184_11]** **[ESPR_3375184_10]**

9ffb31ef916ac1cd087594906fb46a7dd674dd1f1f891839bf837a435a2004c8

- **Prescription volumes have remained generally flat since the label update**, with only 1% to 5% growth over the last two weeks, raising concerns about the timing of script re-acceleration.  **[ESPR_3386772_5]**
- **It may take up to two quarters for payer utilization management criteria to align with the new label**, potentially delaying wider patient access and impacting near-term sales growth.  **[ESPR_3386772_6]**
- **The target patient population for statin intolerance might be smaller than expected**, as only about **10%** of patients are completely unable or unwilling to take statins, which could limit the market potential.  **[ESPR_3386772_8]**

53b65e8772cd43d4796f9c7b0832ba0f430489540155deab52e5f401d459b87b

- **Only 65%** of Medicare lives are currently covered under preferred status, leaving a significant portion of the Medicare market not yet accessible, which may limit growth potential in this important patient population.  **[ESPR_3406499_8]**
- **Medicare patients face higher out-of-pocket costs** with average co-pays around **$45**, compared to **$25** for commercial patients, which may hinder adoption among Medicare patients who represent a significant portion of the target population.  **[ESPR_3406499_13]**
- Upcoming changes due to the **Inflation Reduction Act** may impact net pricing and the company's revenue, introducing uncertainty into future financial performance.  **[ESPR_3406499_11]**

7b0586cb113364a408ee3cb092f8b5d42ea148cc6568442d18aaaab2cd153e35

- **Potential for early generic competition**: With the **NCE-1 date having passed**, generic companies can now file ANDAs for generic versions of **NEXLETOL and NEXLIZET**, potentially leading to earlier than expected generic competition. The company acknowledged they have been expecting this but have **not yet received any Paragraph IV notifications**.  **[ESPR_3375184_12]**
- **Delayed realization of manufacturing cost savings**: The **manufacturing transition to Daiichi Sankyo Europe (DSE)** is expected to take **16 to 18 months**, with **no significant gross margin savings anticipated until next year**. This means that the expected cost improvements from this shift **will not benefit 2024 financials**.  **[ESPR_3375184_13]**
- **Uncertainty around payer coverage post-label expansion**: Despite the upcoming **label expansion**, there is **uncertainty about how payers will adjust their coverage** of the drug. While the company is engaging with payers, the impact on **payer reimbursement and physician adoption** remains unclear, which could affect the anticipated growth from the label update.  **[ESPR_3375184_10]**

08c1799cb5f7a57693c9a88c60b3546e497a67a9b143e0d4befbb4e4f32ee4b5

- **Esperion's U.S. product revenue grew by 14% sequentially from Q1 to Q2**, demonstrating strong momentum and continuous growth in prescriptions. The company is confident in delivering progressive, continuous growth quarter-over-quarter and year-over-year.  **[ESPR_3398368_10]**
- **Coverage has significantly improved**, with over **90% of commercial plans** and **over 50% of Medicare** now covering Esperion's products. Utilization management criteria have become easier, with some accounts requiring no prior authorizations, enhancing patient access and driving prescription growth.  **[ESPR_3398368_9]**
- Positive physician feedback and confidence are increasing following label changes and prior authorization improvements, leading to continued prescription growth. The company is "happy with the overall **14%** growth" delivered from Q1 to Q2 and expects this momentum to continue.  **[ESPR_3398368_8]**

7158e75f69d2f3c18898464c9cca8f802e7bbc8d35701edd832c9f1688a824fd

- **Significant expansion in Medicare coverage, from 28% at launch to over 65% currently, increases patient access and drives growth.** The company expects further expansion, providing access to a larger patient population and enhancing prescription growth. They now cover **90% of U.S. national lives** between commercial and Medicare coverage.  **[ESPR_3406499_8]**
- **Removal of utilization management barriers simplifies prescribing and enhances competitiveness.** The company successfully negotiated the removal of prior authorizations and step edits through ezetimibe and statins, making it easier for physicians to prescribe NEXLETOL and NEXLIZET. In some large accounts like **SilverScript's Caremark and Aetna, there is no prior authorization required.**  **[ESPR_3406499_10]**
- **Strong prescription growth momentum indicates successful commercialization efforts.** The company reported **double-digit growth on all metrics in Q3**, with Q4 starting strong. Improved access and increased physician confidence have contributed to this momentum, and the company is confident that **Q4 revenue will be higher than Q3.**  **[ESPR_3406499_7]**

2233c8e2e092af21c29961444a6c019fb5ee0cb54a2ec03b7159d750f8f0d715

Esperion Therapeutics Inc (ESPR)

Financials