DBV Technologies S.A. (DBVT): Business Model Canvas [11-2024 Updated]

In the rapidly evolving landscape of biopharmaceuticals, DBV Technologies S.A. (DBVT) is making waves with its innovative approach to treating food allergies through its proprietary Viaskin technology. This blog post delves into the Business Model Canvas of DBVT, highlighting key aspects such as partnerships, value propositions, and revenue streams. Discover how this company is positioning itself for success in the healthcare market and what sets it apart in the quest for effective, non-invasive treatments.

DBV Technologies S.A. (DBVT) - Business Model: Key Partnerships

Collaborations with research organizations

DBV Technologies has historically engaged in collaborations with various research organizations to enhance its R&D capabilities. Significant collaborations have included partnerships that contributed to the development of its proprietary Viaskin platform, particularly in the context of peanut allergy treatments.

As of September 30, 2024, the company reported a substantial increase in external clinical-related expenses, amounting to $49.7 million for the nine months ended September 30, 2024, up from $34.2 million in the same period in 2023, reflecting the costs associated with ongoing clinical trials.

Collaboration Partner	Focus Area	Financial Commitment (as of 2024)
NESTEC S.A.	Development of MAG1C through Phase 3 clinical trials	Terminated partnership, previously significant
Various CROs	Clinical trial management and execution	$162.4 million in ongoing trial expenses

Partnerships with healthcare providers

DBV Technologies maintains strategic partnerships with healthcare providers to facilitate clinical trials and ensure effective patient recruitment. These partnerships are critical for the successful execution of clinical studies, particularly for the Viaskin Peanut product, which is aimed at treating peanut allergies in children.

The company has focused on expanding its network of healthcare providers across North America and Europe, with a notable increase in personnel expenses related to these activities, which reached $731,000 for the nine months ending September 30, 2024, compared to $557,000 in 2023.

Healthcare Provider Type	Role in Partnership	Financial Impact (2024)
Clinical Research Centers	Conduct clinical trials for Viaskin Peanut	Part of $162.4 million in trial expenses
Patient Advocacy Groups	Facilitate patient recruitment and education	Indirect financial support through awareness campaigns

Regulatory bodies for product approval

DBV Technologies actively engages with regulatory bodies such as the FDA and EMA to secure approvals for its product candidates. The company has submitted various inquiries and applications to streamline the approval process for its Viaskin Peanut patch, which is pivotal for its market entry strategy.

The company reported a significant financial commitment to regulatory and manufacturing activities, amounting to $9.9 million in the nine months ended September 30, 2024. This reflects the ongoing costs associated with meeting regulatory requirements and preparing for potential product launch.

Regulatory Body	Focus Area	Financial Commitment (2024)
FDA	Approval of Viaskin Peanut	$9.9 million in regulatory activities
EMA	Market authorization for European launch	Included in overall regulatory expenses

DBV Technologies S.A. (DBVT) - Business Model: Key Activities

Research and development of Viaskin technology

DBV Technologies S.A. has focused its key activities on the research and development of its proprietary Viaskin technology, which is designed to treat peanut allergies. For the nine months ended September 30, 2024, the company incurred $70.4 million in research and development expenses, representing an increase of 48.5% compared to $47.4 million in the same period of 2023. This increase was primarily driven by external clinical-related expenses, which rose by $15.5 million to $49.7 million.

Expense Type	2024 Amount (in $ million)	2023 Amount (in $ million)	Change ($ million)	% Change
External clinical-related expenses	49.7	34.2	15.5	45.5%
Employee-related costs	13.1	9.8	3.3	33.3%
Share-based payment expenses	2.2	1.9	0.3	16.2%
Depreciation, amortization and other costs	5.5	1.6	3.9	243.5%
Total R&D Expenses	70.4	47.4	23.0	48.5%

Clinical trials for product candidates

The company is advancing its clinical trials, particularly the VITESSE Phase 3 trial for the Viaskin Peanut patch. As of September 30, 2024, net cash flows used in operating activities amounted to $92.2 million, an increase of $26.3 million compared to $66.0 million for the same period in 2023. The increase in cash usage was largely attributed to heightened external clinical-related expenses and regulatory activities.

In preparation for the trials, DBV Technologies has committed approximately $162.4 million globally as of September 30, 2024, compared to $114.4 million as of December 31, 2023. This financial commitment underscores the company's dedication to advancing its clinical programs.

Clinical Trial Expenses	2024 Amount (in $ million)	2023 Amount (in $ million)	Change ($ million)
Total Clinical Trial Commitments	162.4	114.4	48.0

Regulatory submissions and compliance

DBV Technologies also engages in regulatory submissions and compliance as part of its key activities. As of September 30, 2024, the company continues to prepare for potential approvals and launches, particularly of the Viaskin Peanut product. The company has incurred significant regulatory and manufacturing activity costs, amounting to $9.9 million.

The overall operating loss for the nine months ended September 30, 2024, was $90.9 million, compared to $61.5 million in the same period of 2023, reflecting the ongoing investments in clinical trials and regulatory activities.

Financial Metrics	2024 Amount (in $ million)	2023 Amount (in $ million)	Change ($ million)
Operating Loss	90.9	61.5	29.4
Regulatory and Manufacturing Costs	9.9	N/A	N/A

DBV Technologies S.A. (DBVT) - Business Model: Key Resources

Proprietary technology platform (Viaskin)

The Viaskin technology platform is DBV Technologies' core asset, designed to deliver biologics through the skin via a patch. The platform is at the forefront of the company's product development, particularly for its lead product, Viaskin Peanut, aimed at treating peanut allergies. As of September 30, 2024, the platform supported ongoing clinical trials, with significant investment allocated to research and development expenses totaling $70.4 million for the nine months ended September 30, 2024.

Experienced R&D team

DBV Technologies boasts a highly skilled research and development team, with an average of 108 employees as of September 30, 2024, up from 97 in the previous year. This increase reflects the company's commitment to enhancing its development capabilities, particularly in Medical, Quality, and Regulatory Affairs. The team is crucial in advancing the Viaskin platform and conducting clinical trials, such as the VITESSE Phase 3 trial, which saw external clinical-related expenses rise by $15.5 million.

Financial resources from equity financing

As of September 30, 2024, DBV Technologies reported $46.4 million in cash and cash equivalents, a decline from $141.4 million at the end of 2023. The company has relied heavily on equity financing to support its operations, including an At-The-Market (ATM) program established in May 2022, allowing for the sale of up to $100 million in American Depositary Shares (ADSs). However, the company has faced challenges, including a net loss of $90.9 million for the nine months ended September 30, 2024, compared to $61.5 million for the same period in 2023.

Financial Metric	September 30, 2024	December 31, 2023	Change
Cash and Cash Equivalents	$46.4 million	$141.4 million	-$94.9 million
Net Loss	$90.9 million	$61.5 million	-$29.4 million
R&D Expenses	$70.4 million	$47.4 million	+$23.0 million
Employee Count	108	97	+11

DBV Technologies S.A. (DBVT) - Business Model: Value Propositions

Innovative epicutaneous immunotherapy for food allergies

DBV Technologies S.A. focuses on developing innovative treatments for food allergies, primarily through its proprietary Viaskin technology. The flagship product, Viaskin Peanut, aims to desensitize patients to peanut allergies by delivering immunotherapy through the skin. This approach leverages the body's immune system to build tolerance to allergens without the need for invasive procedures.

Non-invasive and self-administered treatment options

The Viaskin Peanut patch is designed to be non-invasive and easy to use, allowing patients to self-administer the treatment at home. This convenience enhances patient compliance and reduces the burden of frequent clinical visits. The patch is applied to the skin, where it delivers small doses of peanut protein, facilitating a gradual immune response that can lead to desensitization over time.

Focus on safety for pediatric patients

DBV Technologies places significant emphasis on the safety of its products, particularly for pediatric patients. The company's clinical trials, including the ongoing VITESSE Phase 3 study, are designed to assess the safety and efficacy of the Viaskin Peanut patch in children aged 4 to 7 years. The focus on pediatric safety is critical, as food allergies are particularly prevalent in this demographic.

Financial Metrics	2024 (Nine Months Ended September 30)	2023 (Nine Months Ended September 30)	% Change
Operating Income	$3.64 million	$6.85 million	-46.9%
Research and Development Expenses	($70.44 million)	($47.45 million)	+48.5%
Sales and Marketing Expenses	($2.26 million)	($1.61 million)	+40.3%
General and Administrative Expenses	($23.67 million)	($22.30 million)	+6.1%
Net Loss	($90.90 million)	($61.54 million)	+47.7%
Basic/Diluted Net Loss per Share	($0.95)	($0.65)	+46.2%

As of September 30, 2024, DBV Technologies had $46.4 million in cash and cash equivalents, a significant decrease from $141.4 million at the end of 2023, reflecting ongoing operational expenses and investments in clinical trials. The company has incurred operating losses since inception, with net cash used for operating activities amounting to $92.2 million during the nine months ended September 30, 2024.

DBV Technologies S.A. (DBVT) - Business Model: Customer Relationships

Engagement with healthcare professionals

DBV Technologies focuses on building strong relationships with healthcare professionals (HCPs) to enhance the understanding and acceptance of its product candidates. The company has increased its sales and marketing expenses to $2.3 million for the nine months ended September 30, 2024, which is a 40.3% increase from $1.6 million in the same period of 2023. This increase is largely attributed to pre-commercialization activities for its lead product, Viaskin Peanut.

Support for patients and caregivers

DBV Technologies provides comprehensive support to patients and caregivers through various programs aimed at improving treatment adherence and overall patient experience. The company has also allocated significant resources towards educational initiatives, which include informational materials and support networks to assist patients in managing their conditions. The total personnel expenses for patient-related activities, including support services, amounted to approximately $731,000 for the nine months ended September 30, 2024, compared to $557,000 in 2023.

Educational resources on food allergies

DBV Technologies is committed to educating both healthcare professionals and patients about food allergies, particularly peanut allergies, through various channels. The company has reported a research tax credit of $3.64 million for the nine months ended September 30, 2024, which reflects its investment in research and educational resources. Furthermore, DBV anticipates the launch of educational campaigns surrounding the Viaskin Peanut patch, targeting both clinicians and patients to raise awareness and understanding of the product's benefits.

Category	2024 Amount (in thousands USD)	2023 Amount (in thousands USD)	% Change
Sales and Marketing Expenses	2,263	1,613	40.3%
Support Services Expenses	731	557	31.4%
Research Tax Credit	3,640	4,978	-26.9%

DBV Technologies S.A. (DBVT) - Business Model: Channels

Direct communication with healthcare providers

DBV Technologies employs a strategy of direct communication with healthcare providers to ensure that its products, particularly the Viaskin Peanut, are effectively positioned and understood within the medical community. This approach facilitates education on product benefits and usage, enhancing the adoption rate among healthcare professionals.

Clinical trial sites for product testing

The company utilizes clinical trial sites as a critical channel for product testing and validation. As of September 30, 2024, DBV Technologies has incurred approximately $162.4 million in expenses related to ongoing clinical trials, a significant increase from $114.4 million reported at the end of 2023. These trials are essential for gathering data that supports product efficacy and safety, which are pivotal for regulatory approval and market entry.

Clinical Trial Expenses (in millions)	2024	2023
Total Clinical Trial Expenses	$162.4	$114.4
Increase in Clinical Trial Expenses	$48.0	N/A

Future commercialization through partnerships

Looking ahead, DBV Technologies plans to leverage partnerships for the commercialization of its products. The company has established an At-The-Market (ATM) program, which aims to raise up to $100 million through sales of American Depositary Shares (ADSs). This funding is intended to support activities associated with the potential approval and launch of Viaskin Peanut, along with advancing other product candidates. As of September 30, 2024, the company held $46.4 million in cash and cash equivalents, down from $141.4 million at the end of 2023.

Financial Overview (in millions)	September 30, 2024	December 31, 2023
Cash and Cash Equivalents	$46.4	$141.4
Net Loss	$90.9	$61.5
Operating Income	$3.6	$6.9

DBV Technologies S.A. (DBVT) - Business Model: Customer Segments

Pediatric patients with food allergies

DBV Technologies primarily targets pediatric patients suffering from food allergies, particularly peanut allergies. In the United States, approximately 2.2% of children are estimated to have a peanut allergy, which translates to around 1.5 million children. The market for peanut allergy treatments is projected to grow significantly, with revenues expected to reach $3 billion by 2026. DBV is focused on developing the Viaskin Peanut patch, which aims to desensitize these young patients to peanuts through a non-invasive method.

Parents and caregivers seeking treatment options

Parents and caregivers represent a crucial customer segment for DBV Technologies. They are actively seeking effective treatment options for their children’s food allergies. A survey indicated that approximately 70% of parents are dissatisfied with current treatment options and are looking for innovative solutions. The financial burden of managing food allergies is significant, with families spending an average of $4,184 annually on related medical expenses, including doctor visits, medications, and emergency care. This segment is particularly motivated by the desire for safer treatment alternatives that reduce the risk of severe allergic reactions.

Healthcare providers specializing in allergy management

Healthcare providers, including allergists and pediatricians, form another essential customer segment for DBV Technologies. These professionals are pivotal in diagnosing and managing food allergies in children. In the U.S., there are approximately 30,000 practicing allergists and related healthcare providers. The increasing prevalence of food allergies has led to a rise in demand for specialized treatments, with a projected annual growth rate of 12% in the allergy treatment market. Providers are particularly interested in innovative therapies that offer improved patient outcomes and can be easily integrated into their treatment protocols.

Customer Segment	Key Statistics	Market Insights
Pediatric Patients	1.5 million children in the U.S. with peanut allergies	$3 billion expected market by 2026
Parents and Caregivers	70% dissatisfied with current treatments	Average annual spending of $4,184 on allergy management
Healthcare Providers	Approx. 30,000 allergists in the U.S.	12% projected annual growth in allergy treatment market

DBV Technologies S.A. (DBVT) - Business Model: Cost Structure

Significant R&D expenses for clinical trials

For the nine months ended September 30, 2024, DBV Technologies incurred $70.4 million in research and development (R&D) expenses, a significant increase of 48.5% compared to $47.4 million for the same period in 2023. The breakdown of R&D expenses is as follows:

Expense Category	2024 (in $ millions)	2023 (in $ millions)	Change (in $ millions)	% Change
External clinical-related expenses	49.7	34.2	15.5	45.5%
Employee-related costs	13.1	9.8	3.3	33.3%
Share-based payment expenses	2.2	1.9	0.3	16.2%
Depreciation, amortization, and other costs	5.5	1.6	3.9	243.5%

The increase in R&D expenses is largely attributed to external clinical-related expenses due to heightened patient enrollment in the VITESSE Phase 3 clinical trial and preparatory activities for the COMFORT studies.

Administrative costs related to operations

General and administrative expenses for the nine months ended September 30, 2024 amounted to $23.7 million, reflecting a 6.1% increase from $22.3 million in 2023. The components of these costs include:

Expense Category	2024 (in $ millions)	2023 (in $ millions)	Change (in $ millions)	% Change
External professional services	8.2	6.4	1.8	28.7%
Employee-related costs	7.0	6.0	1.0	16.2%
Share-based payment expenses	2.8	2.8	0.0	-0.7%
Depreciation, amortization, and other costs	5.7	7.1	(1.4)	-19.9%

The rise in general and administrative expenses is primarily due to one-time costs associated with office relocations and financing activities.

Marketing expenses for future product launch

Sales and marketing expenses totaled $2.3 million for the nine months ended September 30, 2024, an increase of 40.3% from $1.6 million in the same period of 2023. This increase is driven by:

Expense Category	2024 (in $ millions)	2023 (in $ millions)	Change (in $ millions)	% Change
Personnel expenses (incl. share-based payment expenses)	0.7	0.6	0.2	31.4%
External professional services and other costs	0.8	0.7	0.1	9.1%
Depreciation, amortization, and other costs	0.8	0.4	0.4	113.0%

The increase in marketing expenses primarily supports pre-commercialization activities for Viaskin Peanut in North America.

DBV Technologies S.A. (DBVT) - Business Model: Revenue Streams

Research Tax Credits as Primary Income

DBV Technologies S.A. primarily derives its operating income from the French research tax credit (Crédit d’Impôt Recherche, or “CIR”). For the nine months ended September 30, 2024, the company reported an operating income of $3.64 million, a decrease from $4.98 million during the same period in 2023, reflecting a 26.9% decline year-over-year.

The reduction in tax credits is attributed to a shift in clinical study activities to North America, which are not eligible for the CIR. The detailed breakdown is as follows:

Operating Income Sources	2024 (9 months)	2023 (9 months)	$ Change	% Change
Research Tax Credit	$3.64 million	$4.98 million	($1.34 million)	(26.9%)
Other Income	$0 million	$1.87 million	($1.87 million)	(100%)
Total Operating Income	$3.64 million	$6.85 million	($3.21 million)	(46.9%)

Potential Future Revenue from Product Sales

DBV Technologies is working towards the commercialization of its lead product, Viaskin Peanut, designed for the treatment of peanut allergies. The company plans to seek additional capital to support the launch, contingent upon regulatory approval. The anticipated revenue from product sales is not yet realized, as the product is still in clinical trials, with significant investments planned for marketing and distribution.

The company has projected that successful commercialization could yield substantial revenues, but specific figures remain speculative pending the outcomes of ongoing trials and regulatory reviews.

Possible Partnerships or Licensing Agreements

DBV Technologies has historically engaged in collaborations to enhance its research and development capabilities. With the termination of its collaboration agreement with NESTEC on October 30, 2023, the company now focuses on establishing new partnerships. The company intends to explore licensing agreements to leverage its technology and product candidates, aiming to generate additional income streams.

Future agreements could potentially include:

• Licensing Viaskin technology to pharmaceutical companies.
• Collaborations with research institutions to develop new treatments.
• Joint ventures for clinical trial funding and product development.

As of September 30, 2024, DBV Technologies reported total liabilities of $39.02 million, with a need for ongoing financing to support its development plans.

Updated on 16 Nov 2024

Resources:

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