Esperion Therapeutics, Inc. (ESPR): Business Model Canvas [11-2024 Updated]

In the competitive landscape of pharmaceutical innovation, Esperion Therapeutics, Inc. (ESPR) stands out with its unique approach to lowering LDL cholesterol. With a focus on non-statin therapies and a robust FDA-approved product portfolio, the company is reshaping cardiovascular care. This blog post delves into the comprehensive Business Model Canvas of Esperion, exploring how its key partnerships, activities, and resources drive value for patients and healthcare providers alike. Read on to discover the intricate elements that define Esperion's strategic framework.

Esperion Therapeutics, Inc. (ESPR) - Business Model: Key Partnerships

Collaborations with DSE, Otsuka, and Daiichi Sankyo

Esperion Therapeutics has established significant collaborations with Daiichi Sankyo (DS), Otsuka Pharmaceutical Co., Ltd, and DSE. In April 2021, Esperion entered into a license and collaboration agreement with Daiichi Sankyo, which included a non-refundable upfront payment of $30 million. Additional milestone payments of up to $175 million are contingent on achieving specific commercial milestones.

For the nine months ended September 30, 2024, collaboration revenue from these partnerships amounted to $179 million, a significant increase from $26.5 million in the same period of 2023. The increase was primarily driven by revenue recognized from the Settlement Agreement with DSE and increased product sales to collaboration partners.

Agreements for Product Development and Commercialization

Esperion's partnerships facilitate the development and commercialization of its products, specifically bempedoic acid and its combination therapies. The company has delegated responsibilities for development and commercialization to its partners in designated territories, allowing it to leverage external expertise and resources.

Under the DS Agreement, Daiichi Sankyo is responsible for the commercialization of bempedoic acid in South Korea, Taiwan, and other territories, with the funding of all development costs. Similarly, Otsuka plans to file a New Drug Application (NDA) for bempedoic acid in Japan by the end of 2024.

Partnerships for Supply of Active Pharmaceutical Ingredients

Esperion has structured its partnerships to include agreements for the supply of active pharmaceutical ingredients (APIs) necessary for product development. The company recognizes revenue from these supply agreements when the partner has taken control of the API or bulk tablets.

For the three months ended September 30, 2024, Esperion recognized $20.5 million in collaboration revenue, reflecting sales of bulk tablets and royalty revenue from collaboration partners. This is an increase from $13.7 million in the same period of 2023.

Partnership	Type	Upfront Payment	Potential Milestone Payments	Collaboration Revenue (9M 2024)
Daiichi Sankyo	License and Collaboration	$30 million	$175 million	$179 million
Otsuka	Product Development	N/A	N/A	Included in total collaboration revenue
DSE	Settlement Agreement	N/A	N/A	Included in total collaboration revenue

Esperion Therapeutics, Inc. (ESPR) - Business Model: Key Activities

Research and Development of Bempedoic Acid Products

Esperion Therapeutics focuses on the research and development of bempedoic acid and its combination with ezetimibe. In the nine months ended September 30, 2024, the company incurred $35.3 million in research and development expenses, a decrease from $68.4 million in the same period of 2023, primarily due to reduced costs associated with the CLEAR Outcomes study.

Clinical Trials and Regulatory Submissions

Clinical trials are a critical part of Esperion's strategy. The company reported $5.6 million in expenses related to ongoing clinical studies during the nine months ended September 30, 2024. The CLEAR Outcomes study results in 2023 led to expanded indications for NEXLETOL and NEXLIZET, with significant regulatory milestones achieved, including FDA approvals for cardiovascular risk reduction.

Marketing and Commercialization of NEXLETOL and NEXLIZET

The marketing and commercialization of NEXLETOL and NEXLIZET are essential activities. Product sales for the nine months ended September 30, 2024, reached $84.2 million, compared to $57.6 million in the same period of 2023. Collaboration revenue for this period was $179.0 million, a significant increase from $26.5 million in the prior year, driven by increased sales and a settlement agreement with DSE.

Key Metrics	Q3 2024	Q3 2023	Change
Product Sales (Net)	$31.1 million	$20.3 million	+$10.8 million
Collaboration Revenue	$20.5 million	$13.7 million	+$6.8 million
Research and Development Expenses	$10.4 million	$14.9 million	- $4.5 million
Selling, General and Administrative Expenses	$40.0 million	$33.2 million	+$6.8 million

Overall, the commercialization efforts and expanded indications for NEXLETOL and NEXLIZET have positioned Esperion to capitalize on the growing market for LDL-C lowering therapies.

Esperion Therapeutics, Inc. (ESPR) - Business Model: Key Resources

FDA-approved product portfolio

Esperion Therapeutics has a robust portfolio of FDA-approved products aimed at lowering LDL-C levels and reducing cardiovascular risk. The main products include:

• NEXLETOL: Approved by the FDA on February 21, 2020, as an adjunct to diet and maximally tolerated statin therapy for adults with HeFH or established ASCVD.
• NEXLIZET: Approved on February 26, 2020, as an adjunct to diet and maximally tolerated statin therapy for similar indications.
• NUSTENDI: Contains bempedoic acid and ezetimibe, approved by the European Commission in March 2020, with an expanded indication for cardiovascular risk reduction approved in May 2024.
• NILEMDO: A first-in-class ACL inhibitor approved in March 2020, with an expanded indication for cardiovascular risk reduction approved in May 2024.

As of September 30, 2024, product sales for NEXLETOL and NEXLIZET totaled approximately $84.2 million, compared to $57.6 million in the same period of 2023, indicating significant growth driven by prescription volume increases.

Experienced management and scientific team

Esperion's management team consists of seasoned professionals with extensive experience in the pharmaceutical and biotechnology sectors. The leadership includes experts in drug development, commercialization, and regulatory affairs, which is critical for navigating the complexities of bringing new therapeutics to market. The scientific team is also robust, with a strong track record in lipidology and cardiovascular disease research.

Key management highlights include:

• CEO with over 25 years of experience in the pharmaceutical industry.
• Chief Medical Officer with a history of leading successful drug development programs.
• Experienced regulatory affairs team that has successfully guided multiple products through the FDA approval process.

Financial resources from equity and collaboration agreements

Esperion has secured substantial financial resources through various channels, including equity financing and collaboration agreements. Key financial figures include:

Financial Metric	2024 (Nine Months Ended September 30)	2023 (Nine Months Ended September 30)
Product Sales, Net	$84.2 million	$57.6 million
Collaboration Revenue	$179.0 million	$26.5 million
Operating Expenses	$204.4 million	$197.3 million
Net Loss	$30.4 million	$152.9 million
Cash and Cash Equivalents	$144.7 million	$82.2 million

In January 2024, Esperion raised approximately $90.7 million through an equity offering, allowing for further investment in product commercialization and research activities.

Additionally, collaboration agreements with partners such as DSE, Otsuka, and Daiichi Sankyo have provided substantial milestone and royalty payments, enhancing Esperion's liquidity and operational capacity.

Esperion Therapeutics, Inc. (ESPR) - Business Model: Value Propositions

Non-statin alternatives for LDL-C lowering

Esperion Therapeutics focuses on developing non-statin therapies to lower low-density lipoprotein cholesterol (LDL-C). The primary products, NEXLETOL (bempedoic acid) and NEXLIZET (bempedoic acid/ezetimibe), provide alternatives for patients who are statin-intolerant or require additional LDL-C lowering beyond what statins can achieve.

NEXLETOL received FDA approval in February 2020 and is indicated for use as an adjunct to diet and maximally tolerated statin therapy for adults with heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) who require additional LDL-C lowering. NEXLIZET, which combines bempedoic acid and ezetimibe, was approved shortly thereafter and offers a dual mechanism of action to lower LDL-C by an average of 38% compared to placebo when added to statin therapy.

Significant cardiovascular risk reduction

In 2024, both NEXLETOL and NEXLIZET received expanded labels from the FDA, including indications for cardiovascular risk reduction. This approval underscores the significant cardiovascular benefits provided by these therapies. The European Commission also approved NUSTENDI, which combines bempedoic acid and ezetimibe, for reducing cardiovascular risk in patients with or at high risk for atherosclerotic cardiovascular disease.

Product	LDL-C Reduction (%)	Cardiovascular Risk Reduction Indication	Approval Date
NEXLETOL	~20% (additional lowering)	Yes	February 2020
NEXLIZET	~38% (compared to placebo)	Yes	June 2020
NUSTENDI	~20% (additional lowering)	Yes	March 2020

First-in-class therapies with unique mechanisms of action

Esperion's product portfolio features first-in-class therapies that target unique mechanisms for LDL-C lowering. NILEMDO, an ACL inhibitor, was approved by the European Commission in March 2020, and it works by reducing cholesterol biosynthesis while simultaneously upregulating LDL receptors. The expanded indications for both NILEMDO and NUSTENDI in May 2024 further established these products as leaders in the market for LDL-C lowering and cardiovascular risk reduction.

In the nine months ended September 30, 2024, Esperion reported product sales of $84.2 million, an increase from $57.6 million in the same period in 2023, reflecting growing prescription volumes for NEXLETOL and NEXLIZET. The collaboration revenue for the same period was $179 million, significantly up from $26.5 million year-over-year, driven primarily by increased product sales and a settlement agreement with DSE.

Metric	2024 (Nine Months)	2023 (Nine Months)	Change ($)
Product Sales	$84.2 million	$57.6 million	$26.6 million
Collaboration Revenue	$179.0 million	$26.5 million	$152.5 million

Esperion Therapeutics, Inc. (ESPR) - Business Model: Customer Relationships

Direct interactions with healthcare providers

Esperion Therapeutics, Inc. engages directly with healthcare providers to promote its products, NEXLETOL and NEXLIZET. As of September 30, 2024, product sales, net reached $84.2 million, an increase from $57.6 million in the same period in 2023, driven by prescription growth volumes. The company has expanded its sales force to enhance these interactions, resulting in increased selling, general, and administrative expenses, which totaled $126.1 million for the nine months ended September 30, 2024, up from $97.1 million in the prior year.

Educational programs for patients and physicians

Esperion invests in educational programs aimed at both patients and healthcare providers. These programs focus on understanding the benefits of LDL-C lowering therapies and medication adherence. The company's collaboration revenue grew to $179.0 million in the nine months ended September 30, 2024, compared to $26.5 million in 2023, indicating successful engagement and educational outreach. This increase is attributed to a Settlement Agreement with DSE and enhanced product sales under collaboration agreements.

Support services for medication adherence

To enhance medication adherence, Esperion provides support services that include patient follow-ups and educational resources. The company has recorded a net loss of $30.4 million for the nine months ended September 30, 2024, a significant improvement from the loss of $152.9 million in the same period in 2023, reflecting better management of operational costs associated with these support services. The investment in these services aims to foster long-term relationships with patients, thereby improving treatment outcomes and overall satisfaction.

Metric	Q3 2024	Q3 2023	Change
Product Sales, Net	$31.1 million	$20.3 million	$10.8 million increase
Collaboration Revenue	$20.5 million	$13.7 million	$6.8 million increase
Selling, General and Administrative Expenses	$40.0 million	$33.2 million	$6.8 million increase
Net Loss	$29.5 million	$41.3 million	$11.8 million improvement

Esperion Therapeutics, Inc. (ESPR) - Business Model: Channels

Direct sales to wholesalers and specialty pharmacies

Esperion Therapeutics generates revenue primarily through direct sales of its products, NEXLETOL and NEXLIZET, to wholesalers and specialty pharmacies. For the three months ended September 30, 2024, the product sales, net reached $31.1 million, a significant increase from $20.3 million in the same period in 2023. The growth is attributed to increased prescription volumes, reflecting a strong demand for these cholesterol-lowering medications.

Period	Product Sales, Net ($ million)	Year-over-Year Growth ($ million)
Q3 2024	31.1	10.8
Q3 2023	20.3	N/A

Esperion's strategy involves selling its products to wholesalers who subsequently distribute them to pharmacies and healthcare providers. This direct sales model allows for efficient distribution and broad market access.

Collaboration partners for international markets

Esperion also collaborates with partners for international market penetration. For the nine months ended September 30, 2024, collaboration revenue was $179.0 million, a substantial increase from $26.5 million in the same period of 2023. This growth is primarily due to increased royalty sales and product sales to collaboration partners.

Period	Collaboration Revenue ($ million)	Year-over-Year Growth ($ million)
9M 2024	179.0	152.5
9M 2023	26.5	N/A

This collaboration is vital for expanding Esperion's reach into global markets where it does not have a direct presence, leveraging the expertise and networks of established pharmaceutical partners.

Digital marketing and healthcare professional outreach

Esperion employs digital marketing strategies alongside outreach to healthcare professionals to promote its products. The company's selling, general, and administrative expenses for the nine months ended September 30, 2024, were $126.1 million, up from $97.1 million in the previous year, reflecting increased investment in marketing and sales initiatives. This includes costs associated with promotional activities aimed at healthcare providers to enhance product awareness and education.

Period	SG&A Expenses ($ million)	Year-over-Year Growth ($ million)
9M 2024	126.1	29.0
9M 2023	97.1	N/A

The increase in SG&A expenses is primarily due to heightened commercial headcount and promotional costs associated with the recent expanded labels for NEXLETOL and NEXLIZET, reflecting the company's commitment to driving sales growth through effective marketing and outreach strategies.

Esperion Therapeutics, Inc. (ESPR) - Business Model: Customer Segments

Patients with elevated LDL-C and cardiovascular risk

Esperion Therapeutics focuses on patients with elevated low-density lipoprotein cholesterol (LDL-C) and those at risk for cardiovascular events. The company’s lead products, NEXLETOL and NEXLIZET, are specifically designed for individuals who are unable to achieve LDL-C goals with statin therapy. In 2024, the FDA expanded the indications for these medications to include cardiovascular risk reduction, significantly broadening the potential patient population.

As of September 30, 2024, Esperion reported product sales of $31.1 million for the third quarter, attributed to an increase in prescription volumes of NEXLETOL and NEXLIZET. Furthermore, the company aims to address the needs of over 38 million adults in the U.S. with high LDL-C levels who are at risk of cardiovascular diseases.

Healthcare providers prescribing cholesterol-lowering medications

Healthcare providers, including cardiologists, primary care physicians, and endocrinologists, are essential customer segments for Esperion. They prescribe cholesterol-lowering medications to patients unable to tolerate statins or those needing additional LDL-C reduction. In the three months ending September 30, 2024, collaboration revenue reached $20.5 million, reflecting increased sales and engagement with healthcare professionals.

Esperion's strategic marketing efforts are aimed at educating healthcare providers about the efficacy and safety of NEXLETOL and NEXLIZET. The products have shown an average LDL-C lowering of 21.1% in patients unable to take statins, as per the CLEAR Outcomes trial. This data supports the value proposition of these medications, enhancing adoption among healthcare practitioners.

Collaborators in international markets

Esperion collaborates with various international partners to expand its market presence beyond the U.S. These collaborations are crucial for entering new territories and increasing product accessibility. For instance, the company has agreements with Daiichi Sankyo and Otsuka Pharmaceutical, which facilitate the distribution and commercialization of its products in Europe and Japan.

As of September 30, 2024, collaboration revenue was noted at $179 million for the nine months period, indicating a growing international footprint and successful partnerships. The company anticipates further growth as it continues to pursue regulatory approvals in additional markets, including Canada and Australia in 2024 and 2025.

Customer Segment	Key Characteristics	Market Size (USD)	Revenue Contribution (2024)
Patients with elevated LDL-C	High LDL-C levels, at risk for cardiovascular events	Over $38 billion potential market in the U.S.	$31.1 million from product sales
Healthcare Providers	Prescribe cholesterol-lowering medications	Growing demand for non-statin therapies	$20.5 million from collaboration revenue
International Collaborators	Partners for product distribution and market expansion	Projected global market growth	$179 million from collaboration revenue

Esperion Therapeutics, Inc. (ESPR) - Business Model: Cost Structure

Research and Development Expenses

Research and development expenses for the nine months ended September 30, 2024, were $35.3 million, compared to $68.4 million for the same period in 2023, reflecting a decrease of $33.1 million. For the three months ended September 30, 2024, R&D expenses were $10.4 million, down from $14.9 million in the same quarter of 2023, a decrease of $4.5 million. This decline was primarily due to reduced costs associated with the CLEAR Outcomes study following its results announcement in 2023.

Selling, General, and Administrative Costs

Selling, general, and administrative expenses for the nine months ended September 30, 2024, totaled $126.1 million, an increase from $97.1 million in the same period of 2023, representing an increase of $29.0 million. In the three months ended September 30, 2024, these costs were $40.0 million, compared to $33.2 million in the prior year, marking an increase of $6.8 million. The increase in SG&A expenses is attributed to higher commercial headcount, bonuses, and promotional expenditures linked to the expanded labels for NEXLETOL and NEXLIZET.

Manufacturing and Supply Chain Costs

Cost of goods sold (COGS) for the nine months ended September 30, 2024, was $42.97 million, compared to $31.82 million for the same period in 2023, indicating an increase of $11.15 million. For the three months ended September 30, 2024, COGS was $17.29 million, up from $13.38 million in 2023, reflecting an increase of $3.91 million. This rise in COGS is primarily linked to increased product sales to collaboration partners under supply agreements.

Cost Category	Q3 2024 (in millions)	Q3 2023 (in millions)	Change (in millions)	9M 2024 (in millions)	9M 2023 (in millions)	Change (in millions)
Research and Development	10.4	14.9	-4.5	35.3	68.4	-33.1
Selling, General and Administrative	40.0	33.2	6.8	126.1	97.1	29.0
Cost of Goods Sold	17.29	13.38	3.91	42.97	31.82	11.15

Esperion Therapeutics, Inc. (ESPR) - Business Model: Revenue Streams

Product sales from NEXLETOL and NEXLIZET

NEXLETOL and NEXLIZET are the primary products of Esperion Therapeutics, approved for lowering LDL-C and reducing cardiovascular risk. For the nine months ended September 30, 2024, product sales, net amounted to $84.2 million, compared to $57.6 million for the same period in 2023, reflecting an increase of $26.6 million due to prescription growth volumes.

For the third quarter of 2024, product sales, net reached $31.1 million, up from $20.3 million in the third quarter of 2023, marking an increase of approximately $10.8 million.

Period	Product Sales (in millions)	Growth (in millions)
Q3 2024	$31.1	$10.8
9M 2024	$84.2	$26.6
Q3 2023	$20.3	-
9M 2023	$57.6	-

Collaboration revenue from partnership agreements

Esperion's collaboration revenue from partnership agreements has significantly increased. For the nine months ended September 30, 2024, collaboration revenue amounted to $179.0 million, compared to $26.5 million for the same period in 2023, representing an increase of $152.5 million. This increase is attributed to revenue recognized from the Settlement Agreement with DSE and increased product sales to collaboration partners.

In the third quarter of 2024, collaboration revenue was $20.5 million, up from $13.7 million in the third quarter of 2023, which reflects a growth of $6.8 million.

Period	Collaboration Revenue (in millions)	Growth (in millions)
Q3 2024	$20.5	$6.8
9M 2024	$179.0	$152.5
Q3 2023	$13.7	-
9M 2023	$26.5	-

Royalties on sales from collaboration partners

Esperion also generates revenue through royalties from sales made by collaboration partners. These royalties are recognized based on the percentage of net product sales. The company recently entered a Royalty Purchase Agreement, receiving $304.7 million for a portion of the royalties payable on net sales of Bempedoic Acid from collaboration partner DSE.

The royalty sale liability established from this agreement is projected to require repayment of 1.7x the purchase price, which totals approximately $518 million. The effective interest rate on this liability is 1.4% as of September 30, 2024.

Royalty Sale Agreement Details	Amount (in millions)
Proceeds from Royalty Sale	$304.7
Total Repayment Obligation	$518.0
Effective Interest Rate	1.4%

Updated on 16 Nov 2024

Resources:

1. Esperion Therapeutics, Inc. (ESPR) Financial Statements – Access the full quarterly financial statements for Q3 2024 to get an in-depth view of Esperion Therapeutics, Inc. (ESPR)' financial performance, including balance sheets, income statements, and cash flow statements.
2. SEC Filings – View Esperion Therapeutics, Inc. (ESPR)' latest filings with the U.S. Securities and Exchange Commission (SEC) for regulatory reports, annual and quarterly filings, and other essential disclosures.