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

Verve Therapeutics, Inc. (VERV) stands at the forefront of innovation in the biotech sector, particularly in the realm of gene editing for cardiovascular diseases. With a focus on delivering transformative therapies that could potentially replace chronic treatments with a single course, Verve leverages strategic partnerships and proprietary technologies to navigate the complex landscape of healthcare. Dive deeper into the intricacies of Verve's business model canvas to uncover how they aim to revolutionize patient care and drive growth in the industry.

Verve Therapeutics, Inc. (VERV) - Business Model: Key Partnerships

Collaborations with Vertex Pharmaceuticals and Eli Lilly

Verve Therapeutics has established significant collaborations with Vertex Pharmaceuticals and Eli Lilly to advance its gene editing technologies. Under the Vertex Agreement, initiated in July 2022, Verve is engaged in a four-year exclusive worldwide research collaboration focused on developing in vivo gene editing candidates for a liver disease. As of September 30, 2024, Verve recognized $8.7 million in revenue related to research services performed under this agreement. Additionally, as of the same date, the company reported $20 million as non-current deferred revenue associated with the Vertex Agreement.

In June 2023, Verve entered into a Research and Collaboration Agreement with Eli Lilly, which became effective in July 2023. This five-year collaboration initially targets Verve’s discovery-stage lipoprotein(a) gene editing program. During the three and nine months ended September 30, 2024, Verve recognized $10.6 million in revenue from the Lilly Agreement. The cumulative catch-up from a $5 million milestone achieved in March 2024 contributed $0.2 million to this total.

License agreements with Harvard and The Broad Institute

Verve holds a critical license agreement with Harvard University and The Broad Institute, established in March 2019. This agreement grants Verve exclusive, worldwide, sublicensable, royalty-bearing licenses to specific base editing technologies. Verve is obligated to pay up to $23.1 million in development milestones and $54 million in sales-based milestones. As of September 30, 2024, a development milestone payment of $0.2 million had been triggered under this agreement.

Furthermore, Verve has a collaboration and license agreement with Beam Therapeutics, which was amended in July 2022. This agreement involves milestone payments, with a development milestone of $0.1 million triggered in the nine months ended September 30, 2024.

Potential partnerships for commercialization and manufacturing

Looking forward, Verve Therapeutics is actively seeking potential partnerships to enhance its commercialization and manufacturing capabilities. The company aims to establish a sales, marketing, and distribution infrastructure to support any drug products that may receive marketing approval. This strategy may involve collaborations with established companies in the pharmaceutical sector.

As of September 30, 2024, Verve reported cash, cash equivalents, and marketable securities totaling $539.9 million, which is expected to fund operating expenses and capital expenditures through 2026. This financial position provides a strong foundation for pursuing additional strategic alliances that may facilitate the commercialization of its gene editing therapies.

Partnership Type	Partner	Agreement Date	Revenue Recognized (2024)	Deferred Revenue	Milestones Payable
Collaboration	Vertex Pharmaceuticals	July 2022	$8.7 million	$20.0 million	N/A
Collaboration	Eli Lilly	June 2023	$10.6 million	$5.7 million (short-term)	$30.7 million (long-term)
License	Harvard/Broad Institute	March 2019	N/A	N/A	$23.1 million (development), $54.0 million (sales)
License	Beam Therapeutics	April 2019 (amended July 2022)	N/A	N/A	$0.1 million (triggered)

Verve Therapeutics, Inc. (VERV) - Business Model: Key Activities

Conducting clinical trials for gene editing therapies

Verve Therapeutics is actively engaged in conducting clinical trials to evaluate its gene editing therapies, particularly targeting cardiovascular diseases. As of September 30, 2024, the company is conducting the following trials:

• Heart-1 trial for VERVE-101, focusing on patients with heterozygous familial hypercholesterolemia (HeFH).
• Heart-2 trial for VERVE-102, assessing safety and tolerability in patients with HeFH and/or premature coronary artery disease (CAD).

As of October 29, 2024, dosing has been completed in seven participants across the first two cohorts of the Heart-2 trial, with the first two doses being 0.3 mg/kg and 0.45 mg/kg. The trials have been well tolerated with no serious adverse events reported .

Developing gene editing and lipid nanoparticle delivery technologies

Verve Therapeutics is focused on advancing its proprietary gene editing technologies and lipid nanoparticle (LNP) delivery systems. The company is working on:

• VERVE-101 and VERVE-102, which target the PCSK9 gene using LNP-mediated delivery to disrupt PCSK9 protein production.
• Utilizing a proprietary GalNAc-LNP delivery technology for VERVE-102, designed to enhance liver cell access through the asialoglycoprotein receptor (ASGPR) or LDL receptor (LDLR).

Research and development expenses for the nine months ended September 30, 2024, totaled $149.3 million, reflecting ongoing investments in technology development .

Engaging in research and development for new product candidates

Verve Therapeutics is committed to ongoing research and development to identify and advance new product candidates. The company allocates significant resources to:

• Conducting preclinical studies to explore new gene editing targets.
• Developing additional product candidates beyond the current PCSK9-focused therapies, including those targeting ANGPTL3.

As of September 30, 2024, Verve's accumulated deficit stood at $692.98 million, indicating substantial investment in R&D to support its pipeline .

Activity	Details	Financial Impact (2024)
Clinical Trials	Conducting Heart-1 and Heart-2 trials for VERVE-101 and VERVE-102.	$149.3 million (R&D expenses)
Gene Editing Development	Advancing LNP delivery technologies and base editing research.	$149.3 million (R&D expenses)
New Product R&D	Identifying and developing new gene editing candidates.	$149.3 million (R&D expenses)

Verve Therapeutics, Inc. (VERV) - Business Model: Key Resources

Proprietary gene editing technology and intellectual property

Verve Therapeutics has developed advanced gene editing technologies, particularly focused on lipid metabolism and cardiovascular diseases. Their lead candidates, VERVE-101 and VERVE-102, utilize proprietary base editing and lipid nanoparticle (LNP) delivery systems. This technology aims to permanently turn off the PCSK9 gene, a critical target for lowering LDL cholesterol.

As of September 30, 2024, the company holds numerous patents related to its gene editing methodologies and LNP technology, which are essential for maintaining competitive advantage in the biotechnology sector.

Financial resources raised through equity offerings and collaborations

Since its inception in 2018, Verve Therapeutics has raised approximately $1.1 billion through various financing activities, including:

• Private placements and public offerings of common stock
• Strategic collaborations with companies like Eli Lilly and Vertex Pharmaceuticals

As of September 30, 2024, Verve reported:

Financial Metric	Value (in millions)
Cash, cash equivalents, and marketable securities	$539.9
Net proceeds from common stock sales (2024)	$24.0
Total collaboration revenue (2024)	$19.3
Milestone payments received from collaborations (2024)	$5.0

Experienced personnel in R&D, clinical development, and operations

Verve Therapeutics has built a robust team of professionals with extensive experience in research and development, clinical trials, and operational management. As of September 30, 2024, the company had:

• Employee-related expenses totaling $63.3 million for the nine months ended September 30, 2024
• Increased headcount to support R&D activities, particularly in clinical trial management
• Significant investment in training and development for staff to enhance operational efficiency

The company anticipates ongoing increases in personnel costs as it expands its clinical programs and prepares for potential commercialization activities.

Verve Therapeutics, Inc. (VERV) - Business Model: Value Propositions

Offering transformative gene editing therapies for cardiovascular diseases

Verve Therapeutics is pioneering a new class of genetic medicines specifically targeting cardiovascular diseases (CVD), focusing on a transformative model that shifts treatment from chronic management to potentially curative gene editing therapies. The company aims to address the leading cause of death globally by developing therapies that could provide lasting solutions for conditions such as familial hypercholesterolemia (FH) and atherosclerotic cardiovascular disease (ASCVD).

Potential for single-course treatments instead of chronic management

The company’s innovative approach includes utilizing gene editing technologies to create single-course treatments that could eliminate the need for lifelong medication. This model significantly reduces the burden on healthcare systems and improves patient adherence, as patients would not need to manage chronic medication regimens. Verve’s lead candidates, VERVE-101 and VERVE-102, are designed to permanently disrupt the PCSK9 gene, which is crucial for regulating LDL cholesterol levels in the blood.

Targeting validated genes for effective LDL-C reduction

Verve Therapeutics focuses on the PCSK9 and ANGPTL3 genes, which have been extensively validated as critical targets for reducing low-density lipoprotein cholesterol (LDL-C). By employing lipid nanoparticle (LNP) delivery mechanisms, these therapies aim to achieve durable reductions in LDL-C levels, potentially altering the course of cardiovascular disease for patients. The efficacy of these gene editing therapies is underscored by the following data:

Metric	Value
Net Loss (Q3 2024)	$50.1 million
Accumulated Deficit (as of Sept 30, 2024)	$693 million
Cash, Cash Equivalents, and Marketable Securities (as of Sept 30, 2024)	$539.9 million
Collaboration Revenue (Q3 2024)	$6.9 million
Research and Development Expenses (Q3 2024)	$49.9 million
Capital Raised Since Inception	$1.1 billion

Through strategic collaborations, such as those with Eli Lilly and Vertex Pharmaceuticals, Verve Therapeutics is positioned to leverage significant resources and expertise, enhancing its capabilities in gene editing. This collaborative approach not only provides financial backing but also accelerates the development of innovative therapies aimed at transforming patient care in cardiovascular disease.

Verve Therapeutics, Inc. (VERV) - Business Model: Customer Relationships

Building relationships with healthcare professionals and payers

Verve Therapeutics places significant emphasis on establishing strong relationships with healthcare professionals and payers. As of September 30, 2024, the company has recognized collaboration revenue of $6.9 million for the third quarter and $19.3 million for the nine months ended September 30, 2024, primarily under their agreements with Vertex Pharmaceuticals and Eli Lilly. These collaborations are essential for fostering trust and facilitating product access in clinical settings.

Engaging in educational initiatives about gene therapies

Verve is actively engaged in educational initiatives aimed at healthcare professionals to enhance understanding of gene therapies. This commitment is reflected in their strategy to ensure that stakeholders are well-informed about the benefits and applications of their gene editing technologies targeting cardiovascular diseases. The company is poised to provide ongoing educational resources as they advance their clinical trials, including the Heart-2 trial for VERVE-102, which has completed dosing in seven participants.

Providing ongoing support for clinical trial participants

Verve Therapeutics recognizes the importance of ongoing support for clinical trial participants. As of October 29, 2024, the Heart-2 clinical trial of VERVE-102 has been well tolerated, with no serious adverse events reported. This reflects the company’s commitment to participant safety and satisfaction, which is critical for maintaining positive relationships with both participants and healthcare providers. Ongoing communication and support are integral to ensuring participant engagement and retention throughout the trial process.

Aspect	Details
Collaboration Revenue (Q3 2024)	$6.9 million
Collaboration Revenue (9M 2024)	$19.3 million
Heart-2 Trial Completion (Participants Dosed)	7 participants
Reported Adverse Events in Heart-2 Trial	None
Cash, Cash Equivalents, and Marketable Securities (as of Sept 30, 2024)	$539.9 million

Verve Therapeutics, Inc. (VERV) - Business Model: Channels

Collaboration agreements for research and development

Verve Therapeutics has established significant collaboration agreements with major pharmaceutical companies, notably Eli Lilly and Vertex Pharmaceuticals. Under the Lilly Agreement, initiated in July 2023, Verve is engaged in a five-year worldwide research collaboration focusing on gene editing programs, particularly targeting lipoprotein(a). In the nine months ended September 30, 2024, Verve recognized $10.6 million in revenue from this collaboration.

Similarly, the Vertex Agreement, effective July 2022, is a four-year collaboration aimed at developing gene editing candidates for liver diseases. For the same period, Verve reported $8.7 million in collaboration revenue from Vertex. These agreements not only provide funding but also enhance Verve's research capabilities through shared expertise and resources.

Future commercialization through direct and partnership-led sales

As of September 30, 2024, Verve Therapeutics has not yet generated revenue from product sales, as it is still in the clinical development phase for its product candidates, including VERVE-101 and VERVE-102. However, the company plans to establish a sales and marketing infrastructure to support future commercialization efforts. This includes direct sales as well as potential partnerships with established pharmaceutical companies for distribution and marketing.

The company’s financial position supports this strategy, with cash, cash equivalents, and marketable securities totaling approximately $539.9 million as of September 30, 2024, which is expected to fund operations through 2026.

Online and medical community engagement for awareness

Verve Therapeutics actively engages with both the online and medical communities to promote awareness of its gene editing technologies and ongoing clinical trials. This engagement strategy includes leveraging digital platforms and social media to reach a broader audience, including potential patients and healthcare professionals. As part of this initiative, the company aims to disseminate information regarding its clinical trial results and the benefits of its therapies.

To measure the effectiveness of these engagement efforts, Verve monitors various metrics, including website traffic and social media engagement rates. These metrics help to assess how well the company communicates its value proposition and builds relationships with stakeholders.

Channel	Collaboration Revenue (2024)	Cash, Cash Equivalents, and Marketable Securities	Projected Funding Duration
Lilly Agreement	$10.6 million	$539.9 million	Through 2026
Vertex Agreement	$8.7 million

Verve Therapeutics, Inc. (VERV) - Business Model: Customer Segments

Patients with cardiovascular diseases, particularly familial hypercholesterolemia

Verve Therapeutics targets patients suffering from cardiovascular diseases (CVD), specifically those with familial hypercholesterolemia (FH). FH is a genetic disorder characterized by high levels of low-density lipoprotein cholesterol (LDL-C), leading to an increased risk of early-onset atherosclerotic cardiovascular disease (ASCVD). It is estimated that FH affects approximately 1 in 200 to 1 in 500 individuals globally, indicating a potential patient population of around 1.5 to 3 million in the United States alone.

Healthcare providers and institutions involved in CVD treatment

Healthcare providers, including cardiologists, primary care physicians, and specialized clinics, form a critical customer segment for Verve. These professionals are essential in diagnosing and managing patients with CVD. The American Heart Association reported that CVD accounted for approximately 697,000 deaths in the U.S. in 2020, emphasizing the necessity for effective treatment options. Verve's gene editing therapies aim to provide healthcare providers with innovative solutions to reduce LDL-C levels effectively.

Pharmaceutical partners for collaborative development

Verve Therapeutics actively collaborates with pharmaceutical companies for the development and commercialization of its gene editing therapies. Notably, the company has entered into strategic collaborations with Vertex Pharmaceuticals and Eli Lilly. In the nine months ended September 30, 2024, Verve recognized $19.3 million in collaboration revenue from these partnerships. These collaborations facilitate shared resources, expertise, and market access, enhancing the potential to reach broader patient populations.

Customer Segment	Characteristics	Market Size (Estimated)	Collaboration Revenue (2024)
Patients with FH	Genetic disorder leading to high LDL-C	1.5 to 3 million in the U.S.	N/A
Healthcare Providers	Cardiologists, clinics, hospitals	Part of the $555 billion U.S. CVD market	N/A
Pharmaceutical Partners	Collaborative development and commercialization	N/A	$19.3 million

Verve Therapeutics, Inc. (VERV) - Business Model: Cost Structure

High research and development expenses for clinical trials

For the nine months ended September 30, 2024, Verve Therapeutics incurred $149.3 million in research and development expenses, compared to $138.1 million for the same period in 2023. This increase of $11.2 million was primarily due to a $12.5 million rise in employee-related expenses, which included stock-based compensation and increased headcount.

Clinical trial costs specifically saw an increase of $6.5 million, associated with the ongoing Heart-2 clinical trial and preparations for the Pulse-1 clinical trial.

Expense Category	2024 (9 Months)	2023 (9 Months)	Change
Research and Development Expenses	$149.3 million	$138.1 million	$11.2 million
Clinical Trial Costs Increase	$6.5 million	N/A	N/A

Significant operational costs associated with manufacturing and compliance

Verve Therapeutics reported operational costs related to manufacturing activities, including third-party contract manufacturing organizations (CMOs), amounting to $27.7 million for the nine months ended September 30, 2024. This reflects a slight decrease of $3.2 million from $30.9 million in 2023.

Facility-related costs, including depreciation, were recorded at $15.9 million for the nine months ended September 30, 2024.

Operational Cost Category	2024 (9 Months)	2023 (9 Months)	Change
Manufacturing Costs (CMOs)	$27.7 million	$30.9 million	($3.2 million)
Facility-Related Costs	$15.9 million	N/A	N/A

Ongoing costs related to public company operations and reporting

General and administrative expenses for the nine months ended September 30, 2024, were $42.5 million, an increase from $37.7 million in the same period of 2023. This increase of approximately $4.9 million was primarily due to a $4.2 million rise in employee-related expenses, including stock-based compensation.

As of September 30, 2024, Verve Therapeutics had accumulated a deficit of $692.9 million.

Public Company Cost Category	2024 (9 Months)	2023 (9 Months)	Change
General and Administrative Expenses	$42.5 million	$37.7 million	$4.9 million
Accumulated Deficit	$692.9 million	N/A	N/A

Verve Therapeutics, Inc. (VERV) - Business Model: Revenue Streams

Collaboration revenue from partnerships with Vertex and Lilly

For the nine months ended September 30, 2024, Verve Therapeutics recognized $19.3 million in collaboration revenue, a significant increase from $6.6 million in the same period of 2023. This revenue was primarily derived from:

• $10.6 million from research services associated with the Lilly Agreement.
• $8.7 million from the Vertex Agreement.

During the three months ended September 30, 2024, collaboration revenue amounted to $6.9 million, comprising $4.2 million from Lilly and $2.7 million from Vertex.

Potential future revenues from product sales upon regulatory approval

Verve Therapeutics is a clinical-stage company and does not expect to generate revenue from product sales in the near future. Future revenues are contingent upon the successful development and regulatory approval of its product candidates, including VERVE-101 and VERVE-102, which target the PCSK9 gene. These products are designed to permanently inhibit the PCSK9 gene expression to lower LDL cholesterol levels.

Milestone payments from collaboration agreements and licensing deals

As part of its collaboration agreements, Verve Therapeutics is eligible for milestone payments. During the nine months ended September 30, 2024, the company received $5.0 million from Lilly due to the achievement of a research and development milestone. The company has recorded $30.7 million in long-term deferred revenue, with $5.7 million classified as short-term deferred revenue.

Revenue Type	Amount (in millions)	Details
Collaboration Revenue (2024 Q3)	$6.9	$4.2M from Lilly; $2.7M from Vertex
Collaboration Revenue (2024 YTD)	$19.3	$10.6M from Lilly; $8.7M from Vertex
Milestone Payments (from Lilly)	$5.0	Received for R&D milestone achievement
Deferred Revenue (Total)	$30.7	$5.7M short-term; $25.0M long-term

Verve Therapeutics is focused on advancing its product candidates through clinical trials to achieve regulatory approval, which will be critical for generating future revenues from product sales.

Updated on 16 Nov 2024

Resources:

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